Impact of a social franchising program on uptake of oral rehydration solution plus zinc for childhood diarrhea in myanmar: a community-level randomized controlled trial.

PubMed

Aung, Tin; Montagu, Dominic; Su Su Khin, Hnin; Win, Zaw; San, Ang Kyaw; McFarland, Willi

2014-06-01

Diarrhea's impact on childhood morbidity can be reduced by administering oral rehydration solution (ORS) with zinc; challenges to wider use are changing health-seeking behavior and ensuring access. We conducted a randomized controlled trial to increase ORS plus zinc uptake in rural Myanmar. Village tracts, matched in 52 pairs, were randomized to standard ORS access vs. a social franchising program training community educators and supplying ORS plus zinc. Intervention and control communities were comparable on demographics, prevalence of diarrhea and previous use of ORS. One year after randomization, ORS plus zinc use was 13.7% in the most recent case of diarrhea in intervention households compared with 1.8% in control households (p < 0.001) (N = 3605). A significant increase in ORS plus zinc use was noted in the intervention (p = 0.044) but not in the control (p = 0.315) group. Social franchising increased optimal treatment of childhood diarrhea in rural Myanmar. Scale-up stands to reduce morbidity among children in similar settings. Current Controlled Trials ISRCTN73606238. © The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Dynamic probability of reinforcement for cooperation: Random game termination in the centipede game.

PubMed

Krockow, Eva M; Colman, Andrew M; Pulford, Briony D

2018-03-01

Experimental games have previously been used to study principles of human interaction. Many such games are characterized by iterated or repeated designs that model dynamic relationships, including reciprocal cooperation. To enable the study of infinite game repetitions and to avoid endgame effects of lower cooperation toward the final game round, investigators have introduced random termination rules. This study extends previous research that has focused narrowly on repeated Prisoner's Dilemma games by conducting a controlled experiment of two-player, random termination Centipede games involving probabilistic reinforcement and characterized by the longest decision sequences reported in the empirical literature to date (24 decision nodes). Specifically, we assessed mean exit points and cooperation rates, and compared the effects of four different termination rules: no random game termination, random game termination with constant termination probability, random game termination with increasing termination probability, and random game termination with decreasing termination probability. We found that although mean exit points were lower for games with shorter expected game lengths, the subjects' cooperativeness was significantly reduced only in the most extreme condition with decreasing computer termination probability and an expected game length of two decision nodes. © 2018 Society for the Experimental Analysis of Behavior.

Do Health Reforms to Improve Quality Have Long-Term Effects? Results of a Follow-Up on a Randomized Policy Experiment in the Philippines.

PubMed

Quimbo, Stella; Wagner, Natascha; Florentino, Jhiedon; Solon, Orville; Peabody, John

2016-02-01

We tracked doctors who had previously participated in a randomized policy experiment in the Philippines. The original experiment involved 30 district hospitals divided equally into one control site and two intervention sites that increased insurance payments (full insurance support for children under 5 years old) or made bonus payments to hospital staff. During the 3 years of the intervention, quality-as measured by clinical performance and value vignettes-improved and was sustained in both intervention sites compared with controls. Five years after the interventions were discontinued, we remeasured the quality of care of the doctors. We found that the intervention sites continued to have significantly higher quality compared with the control sites. The previously documented quality improvement in intervention sites appears to be sustained; moreover, it was subject to a very low (less than 1% per year) rate of decay in quality scores. Copyright © 2015 John Wiley & Sons, Ltd.

Oral contraceptive use changes brain activity and mood in women with previous negative affect on the pill--a double-blinded, placebo-controlled randomized trial of a levonorgestrel-containing combined oral contraceptive.

PubMed

Gingnell, Malin; Engman, Jonas; Frick, Andreas; Moby, Lena; Wikström, Johan; Fredrikson, Mats; Sundström-Poromaa, Inger

2013-07-01

Most women on combined oral contraceptives (COC) report high levels of satisfaction, but 4-10% complain of adverse mood effects. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate if COC use would induce more pronounced mood symptoms than placebo in women with previous history of COC-induced adverse mood. A second aim was to determine if COC use is associated with changes in brain reactivity in regions previously associated with emotion processing. Thirty-four women with previous experience of mood deterioration during COC use were randomized to one treatment cycle with a levonorgestrel-containing COC or placebo. An emotional face matching task (vs. geometrical shapes) was administered during functional magnetic resonance imaging (fMRI) prior to and during the COC treatment cycle. Throughout the trial, women recorded daily symptom ratings on the Cyclicity Diagnoser (CD) scale. During the last week of the treatment cycle COC users had higher scores of depressed mood, mood swings, and fatigue than placebo users. COC users also had lower emotion-induced reactivity in the left insula, left middle frontal gyrus, and bilateral inferior frontal gyri as compared to placebo users. In comparison with their pretreatment cycle, the COC group had decreased emotion-induced reactivity in the bilateral inferior frontal gyri, whereas placebo users had decreased reactivity in the right amygdala. COC use in women who previously had experienced emotional side effects resulted in mood deterioration, and COC use was also accompanied by changes in emotional brain reactivity. These findings are of relevance for the understanding of how combined oral contraceptives may influence mood. Placebo-controlled fMRI studies in COC sensitive women could be of relevance for future testing of adverse mood effects in new oral contraceptives. Copyright © 2012 Elsevier Ltd. All rights reserved.

A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis

PubMed Central

Chao, Ming; Wu, Hao; Jin, Kai; Li, Bin; Wu, Jianjun; Zhang, Guangqiang; Yang, Gong; Hu, Xun

2016-01-01

Study design: Previous works suggested that neutralizing intratumoral lactic acidosis combined with glucose deprivation may deliver an effective approach to control tumor. We did a pilot clinical investigation, including a nonrandomized (57 patients with large HCC) and a randomized controlled (20 patients with large HCC) studies. Methods: The patients were treated with transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor. Results: In the nonrandomized controlled study, geometric mean of viable tumor residues (VTR) in TACE with bicarbonate was 6.4-fold lower than that in TACE without bicarbonate (7.1% [95% CI: 4.6%–10.9%] vs 45.6% [28.9%–72.0%]; p<0.0001). This difference was recapitulated by a subsequent randomized controlled study. TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized). The survival data suggested that bicarbonate may bring survival benefit. Conclusion: Bicarbonate markedly enhances the anticancer activity of TACE. Clinical trail registration: ChiCTR-IOR-14005319. DOI: http://dx.doi.org/10.7554/eLife.15691.001 PMID:27481188

The use of a non-benzodiazepine hypnotic sleep-aid (Zolpidem) in patients undergoing ACL reconstruction: a randomized controlled clinical trial.

PubMed

Tompkins, Marc; Plante, Matthew; Monchik, Keith; Fleming, Braden; Fadale, Paul

2011-05-01

Previous studies have addressed post-operative pain management after ACL reconstruction by examining the use of intra-articular analgesia and/or modification of anesthesia techniques. To our knowledge, however, no previous studies have evaluated the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction. The purpose of this prospective, blinded, randomized, controlled clinical study was to evaluate the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction. Twenty-nine patients undergoing arthroscopic ACL reconstruction were randomized to a treatment group or placebo group. Both groups received post-operative hydrocodone/acetaminophen bitartrate (Vicodin ES). Patients in the treatment group received a single dose of zolpidem for the first seven post-operative nights. Patients in the placebo group received a gelatin capsule similar in appearance to zolpidem. The amount of Vicodin used in each group, the amount of post-operative pain, and the amount of post-operative fatigue were analyzed. Following ACL reconstruction, a 28% reduction was seen in the total amount of narcotic consumed with zolpidem (P = 0.047) when compared to placebo. There were no significant differences in post-operative pain or fatigue levels between zolpidem and placebo. Adding zolpidem to the post-operative medication regimen after arthroscopic ACL reconstruction helps to lower the amount of narcotic pain medication required for adequate analgesia. Randomized controlled clinical trial, Level I.

SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer.

PubMed

van Hazel, Guy A; Heinemann, Volker; Sharma, Navesh K; Findlay, Michael P N; Ricke, Jens; Peeters, Marc; Perez, David; Robinson, Bridget A; Strickland, Andrew H; Ferguson, Tom; Rodríguez, Javier; Kröning, Hendrik; Wolf, Ido; Ganju, Vinod; Walpole, Euan; Boucher, Eveline; Tichler, Thomas; Shacham-Shmueli, Einat; Powell, Alex; Eliadis, Paul; Isaacs, Richard; Price, David; Moeslein, Fred; Taieb, Julien; Bower, Geoff; Gebski, Val; Van Buskirk, Mark; Cade, David N; Thurston, Kenneth; Gibbs, Peter

2016-05-20

SIRFLOX was a randomized, multicenter trial designed to assess the efficacy and safety of adding selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres to standard fluorouracil, leucovorin, and oxaliplatin (FOLFOX)-based chemotherapy in patients with previously untreated metastatic colorectal cancer. Chemotherapy-naïve patients with liver metastases plus or minus limited extrahepatic metastases were randomly assigned to receive either modified FOLFOX (mFOLFOX6; control) or mFOLFOX6 plus SIRT (SIRT) plus or minus bevacizumab. The primary end point was progression-free survival (PFS) at any site as assessed by independent centralized radiology review blinded to study arm. Between October 2006 and April 2013, 530 patients were randomly assigned to treatment (control, 263; SIRT, 267). Median PFS at any site was 10.2 v 10.7 months in control versus SIRT (hazard ratio, 0.93; 95% CI, 0.77 to 1.12; P = .43). Median PFS in the liver by competing risk analysis was 12.6 v 20.5 months in control versus SIRT (hazard ratio, 0.69; 95% CI, 0.55 to 0.90; P = .002). Objective response rates (ORRs) at any site were similar (68.1% v 76.4% in control v SIRT; P = .113). ORR in the liver was improved with the addition of SIRT (68.8% v 78.7% in control v SIRT; P = .042). Grade ≥ 3 adverse events, including recognized SIRT-related effects, were reported in 73.4% and 85.4% of patients in control versus SIRT. The addition of SIRT to FOLFOX-based first-line chemotherapy in patients with liver-dominant or liver-only metastatic colorectal cancer did not improve PFS at any site but significantly delayed disease progression in the liver. The safety profile was as expected and was consistent with previous studies. © 2016 by American Society of Clinical Oncology.

Role of re-screening of cervical smears in internal quality control.

PubMed Central

Baker, A; Melcher, D; Smith, R

1995-01-01

AIMS--To investigate the use of rapid re-screening as a quality control method for previously screened cervical slides; to compare this method with 10% random re-screening and clinically indicated double screening. METHODS--Between June 1990 and December 1994, 117,890 negative smears were subjected to rapid re-screening. RESULTS--This study shows that rapid re-screening detects far greater numbers of false negative cases when compared with both 10% random re-screening and clinically indicated double screening, with no additional demand on human resources. The technique also identifies variation in the performance of screening personnel as an additional benefit. CONCLUSION--Rapid re-screening is an effective method of quality control. Although less sensitive, rapid re-screening should replace 10% random re-screening and selected re-screening as greater numbers of false negative results are detected while consuming less resources. PMID:8543619

Statins but Not Aspirin Reduce Thrombotic Risk Assessed by Thrombin Generation in Diabetic Patients without Cardiovascular Events: The RATIONAL Trial

PubMed Central

Macchia, Alejandro; Laffaye, Nicolás; Comignani, Pablo D.; Cornejo Pucci, Elena; Igarzabal, Cecilia; Scazziota, Alejandra S.; Herrera, Lourdes; Mariani, Javier A.; Bragagnolo, Julio C.; Catalano, Hugo; Tognoni, Gianni; Nicolucci, Antonio

2012-01-01

Background The systematic use of aspirin and statins in patients with diabetes and no previous cardiovascular events is controversial. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG) among patients with type II diabetes mellitus and no previous cardiovascular events. Methodology/Principal Findings Prospective, randomized, open, blinded to events evaluation, controlled, 2×2 factorial clinical trial including 30 patients randomly allocated to aspirin 100 mg/d, atorvastatin 40 mg/d, both or none. Outcome measurements included changes in TG levels after treatment (8 to 10 weeks), assessed by a calibrated automated thrombogram. At baseline all groups had similar clinical and biochemical profiles, including TG levels. There was no interaction between aspirin and atorvastatin. Atorvastatin significantly reduced TG measured as peak TG with saline (85.09±55.34 nmol vs 153.26±75.55 nmol for atorvastatin and control groups, respectively; p = 0.018). On the other hand, aspirin had no effect on TG (121.51±81.83 nmol vs 116.85±67.66 nmol, for aspirin and control groups, respectively; p = 0.716). The effects of treatments on measurements of TG using other agonists were consistent. Conclusions/Significance While waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by TG. Trial Registration ClinicalTrials.gov NCT00793754 PMID:22470429

Effect of metformin added to insulin on glycemic control among overweight/obese adolescents with type 1 diabetes: A randomized clinical trial

USDA-ARS?s Scientific Manuscript database

Previous studies assessing the effect of metformin on glycemic control in adolescents with type 1 diabetes have produced inconclusive results. To assess the efficacy and safety of metformin as an adjunct to insulin in treating overweight adolescents with type 1 diabetes. Multicenter (26 pediatric en...

Positive Outlook as a Moderator of the Effectiveness of an HIV/STI Intervention with Adolescents in Detention

ERIC Educational Resources Information Center

Schmiege, Sarah J.; Ewing, Sarah W. Feldstein; Hendershot, Christian S.; Bryan, Angela D.

2011-01-01

Justice-involved adolescents engage in high levels of risky sexual behavior, underscoring the need for targeted, effective, prevention interventions geared toward this population. In a randomized controlled trial, 484 detained adolescents received a theory-based intervention or an information-only control. We have previously demonstrated that the…

Effects of a Community Toxic Release on the Psychological Status of Children

ERIC Educational Resources Information Center

Greve, Kevin W.; Bianchini, Kevin J.; Stickle, Timothy R.; Love, Jeffrey M.; Doane, Bridget M.; Thompson, Matthew D.

2007-01-01

This study sought to determine the emotional effects of a major community toxic release on children in the exposed community while controlling for the potential effects of response bias. Controlling for the response bias inherent in litigated contexts is an advance over previous studies of toxic exposure in children. A randomly selected…

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

PubMed Central

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

2012-01-01

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

A multicenter randomized controlled evaluation of automated home monitoring and telephonic disease management in patients recently hospitalized for congestive heart failure: the SPAN-CHF II trial.

PubMed

Weintraub, Andrew; Gregory, Douglas; Patel, Ayan R; Levine, Daniel; Venesy, David; Perry, Kathleen; Delano, Christine; Konstam, Marvin A

2010-04-01

We performed a prospective, randomized investigation assessing the incremental effect of automated health monitoring (AHM) technology over and above that of a previously described nurse directed heart failure (HF) disease management program. The AHM system measured and transmitted body weight, blood pressure, and heart rate data as well as subjective patient self-assessments via a standard telephone line to a central server. A total of 188 consented and eligible patients were randomized between intervention and control groups in 1:1 ratio. Subjects randomized to the control arm received the Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) heart failure disease management program. Subjects randomized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system. The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days. The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 (95%CI [0.25-0.99], P = .05). Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment. Long-term benefits in this model remain to be studied. (c) 2010 Elsevier Inc. All rights reserved.

Implantable cardioverter defibrillators for primary prevention in patients with nonischemic cardiomyopathy: A systematic review and meta-analysis.

PubMed

Akel, Tamer; Lafferty, James

2017-06-01

Implantable cardioverter defibrillators (ICDs) have proved their favorable outcomes on survival in selected patients with cardiomyopathy. Although previous meta-analyses have shown benefit for their use in primary prevention, the evidence remains less robust for patients with nonischemic cardiomyopathy (NICM) in comparison to patients with coronary artery disease (CAD). To evaluate the effect of ICD therapy on reducing all-cause mortality and sudden cardiac death (SCD) in patients with NICM. PubMed (1993-2016), the Cochrane Central Register of Controlled Trials (2000-2016), reference lists of relevant articles, and previous meta-analyses. Search terms included defibrillator, heart failure, cardiomyopathy, randomized controlled trials, and clinical trials. Eligible trials were randomized controlled trials with at least an arm of ICD, an arm of medical therapy and enrolled some patients with NICM. The primary endpoint in the trials should include all-cause mortality or mortality from SCD. Hazard ratios (HRs) for all-cause mortality and mortality from SCD were either extracted or calculated along with their standard errors. Of the 1047 abstracts retained by the initial screen, eight randomized controlled trials were identified. Five of these trials reported relevant data regarding patients with NICM and were subsequently included in this meta-analysis. Pooled analysis of HRs suggested a statistically significant reduction in all-cause mortality among a total of 2573 patients randomized to ICD vs medical therapy (HR 0.80; 95% CI, 0.67-0.96; P=.02). Pooled analysis of HRs for mortality from SCD was also statistically significant (n=1677) (HR 0.51; 95% CI, 0.34-0.76; P=.001). ICD implantation is beneficial in terms of all-cause mortality and mortality from SCD in certain subgroups of patients with NICM. © 2017 John Wiley & Sons Ltd.

Study protocol for a randomized controlled trial: tongue strengthening exercises in head and neck cancer patients, does exercise load matter?

PubMed

Van Nuffelen, Gwen; Van den Steen, Leen; Vanderveken, Olivier; Specenier, Pol; Van Laer, Carl; Van Rompaey, Diane; Guns, Cindy; Mariën, Steven; Peeters, Marc; Van de Heyning, Paul; Vanderwegen, Jan; De Bodt, Marc

2015-09-04

Reduced tongue strength is an important factor contributing to early and late dysphagia in head and neck cancer patients previously treated with chemoradiotherapy. The evidence is growing that tongue strengthening exercises can improve tongue strength and swallowing function in both healthy and dysphagic subjects. However, little is known about the impact of specific features of an exercise protocol for tongue strength on the actual outcome (strength or swallowing function). Previous research originating in the fields of sports medicine and physical rehabilitation shows that the degree of exercise load is an influential factor for increasing muscle strength in the limb skeletal muscles. Since the tongue is considered a muscular hydrostat, it remains to be proven whether the same concepts will apply. This ongoing randomized controlled trial in chemoradiotherapy-treated patients with head and neck cancer investigates the effect of three tongue strengthening exercise protocols, with different degrees of exercise load, on tongue strength and swallowing. At enrollment, 51 patients whose dysphagia is primarily related to reduced tongue strength are randomly assigned to a training schedule of 60, 80, or 100% of their maximal tongue strength. Patients are treated three times a week for 8 weeks, executing 120 repetitions of the assigned exercise once per training day. Exercise load is progressively adjusted every 2 weeks. Patients are evaluated before, during and after treatment by means of tongue strength measurements, fiber-optic endoscopic evaluation of swallowing and quality-of-life questionnaires. This randomized controlled trial is the first to systematically investigate the effect of different exercise loads in tongue strengthening exercise protocols. The results will allow the development of more efficacious protocols. Current Controlled Trials ISRCTN14447678.

Parkinson's Patients with Dyskinesia Switched from Immediate Release Amantadine to Open‐label ADS‐5102

PubMed Central

Fahn, Stanley; Pahwa, Rajesh; Tanner, Caroline M.; Espay, Alberto J.; Trenkwalder, Claudia; Adler, Charles H.; Patni, Rajiv; Johnson, Reed

2018-01-01

Abstract Background ADS‐5102 (amantadine) extended release capsules (GOCOVRI™) are a treatment for dyskinesia in patients with Parkinson's disease (PD). ADS‐5102 reduced dyskinesia and OFF time in phase 3 controlled trials of up to six months. Amantadine immediate release (IR) is used for dyskinesia, but suboptimal durability and tolerability limit its clinical utility. Methods In an ongoing, open‐label, phase 3 study in the US and Western Europe (NCT02202551), patients with PD received 274 mg of ADS‐5102 (equivalent to 340 mg amantadine HCl) once daily at bedtime for up to two years. Study outcomes included safety and assessment of motor complications, as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS‐UPDRS) Part IV. This manuscript focuses on those patients switched to ADS‐5102 from amantadine IR. Results in two groups of patients who previously completed a randomized controlled trial (EASE LID or EASE LID 3) are also presented according to use of ADS‐5102 or placebo in that study before enrollment in the open‐label study. Results Change in MDS‐UPDRS Part IV at week 8 was –0.3 in the previous ADS‐5102 subgroup (n = 61), –3.4 in the previous placebo subgroup (n = 79), and –3.4 in the previous amantadine IR subgroup (n = 32). Effects were maintained to week 64. In the previous amantadine IR subgroup (mean treatment duration, 2.5 years), mean amantadine IR dose was 221 mg. Safety data were consistent with previous randomized controlled trials of ADS‐5102. Conclusion These open‐label data suggest ADS‐5102 provides incremental reduction from baseline in MDS‐UDPRS Part IV score in patients switched directly from amantadine IR, without exacerbating adverse events.

Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review.

PubMed

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-11-30

Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%-80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.

Are mammographic changes in the tumor bed more pronounced after intraoperative radiotherapy for breast cancer? Subgroup analysis from a randomized trial (TARGIT-A).

PubMed

Engel, Dorothee; Schnitzer, Andreas; Brade, Joachim; Blank, Elena; Wenz, Frederik; Suetterlin, Marc; Schoenberg, Stefan; Wasser, Klaus

2013-01-01

Intraoperative radiotherapy (IORT) with low-energy x-rays is increasingly used in breast-conserving therapy (BCT). Previous non-randomized studies have observed mammographic changes in the tumor bed to be more pronounced after IORT. The purpose of this study was to reassess the postoperative changes in a randomized single-center subgroup of patients from a multicenter trial (TARGIT-A). In this subgroup (n = 48) 27 patients received BCT with IORT, 21 patients had BCT with standard whole-breast radiotherapy serving as controls. Overall 258 postoperative mammograms (median follow-up 4.3 years, range 3-8) were retrospectively evaluated by two radiologists in consensus focusing on changes in the tumor bed. Fat necroses showed to be significantly more frequent (56% versus 24%) and larger (8.7 versus 1.6 sq cm, median) after IORT than those in controls. Scar calcifications were also significantly more frequent after IORT (63% versus 19%). The high incidence of large fat necroses in our study confirms previous study findings. However, the overall higher incidence of calcifications in the tumor bed after IORT represents a new finding, requiring further attention. © 2012 Wiley Periodicals, Inc.

Retreatment With Varenicline for Smoking Cessation in Smokers Who Have Previously Taken Varenicline: A Randomized, Placebo-Controlled Trial

PubMed Central

Gonzales, D; Hajek, P; Pliamm, L; Nackaerts, K; Tseng, L-J; McRae, T D; Treadow, J

2014-01-01

The efficacy and safety of retreatment with varenicline in smokers attempting to quit were evaluated in this randomized, double-blind, placebo-controlled, multicenter trial (Australia, Belgium, Canada, the Czech Republic, France, Germany, the United Kingdom, and the United States). Participants were generally healthy adult smokers (≥10 cigarettes/day) with ≥1 prior quit attempt (≥2 weeks) using varenicline and no quit attempts in ≤3 months; they were randomly assigned (1:1) to 12 weeks' varenicline (n = 251) or placebo (n = 247) treatment, with individual counseling, plus 40 weeks' nontreatment follow-up. The primary efficacy end point was the carbon monoxide–confirmed (≤10 ppm) continuous abstinence rate for weeks 9–12, which was 45.0% (varenicline; n = 249) vs. 11.8% (placebo; n = 245; odds ratio: 7.08; 95% confidence interval: 4.34, 11.55; P < 0.0001). Common varenicline group adverse events were nausea, abnormal dreams, and headache, with no reported suicidal behavior. Varenicline is efficacious and well tolerated in smokers who have previously taken it. Abstinence rates are comparable with rates reported for varenicline-naive smokers. PMID:24911368

Enhancing the parent-child relationship: a Hong Kong community-based randomized controlled trial.

PubMed

Fabrizio, Cecilia S; Stewart, Sunita M; Ip, Alison K Y; Lam, Tai Hing

2014-02-01

Adolescence is a critical risk period for negative academic and behavioral outcomes, but a strong parent-child relationship can be a powerful protective factor. Our previous pilot of an academic-community agency collaborative randomized controlled trial (RCT) demonstrated initial evidence of benefit for a parenting intervention with preadolescents in Hong Kong. The present RCT assessed the effect of brief training in positive discipline parenting skills on parental satisfaction with the parent-child relationship. A community sample of 461 Hong Kong Chinese parents of children aged 10-13 years were randomized to (a) the Harmony@Home intervention, (b) an attention control, or (c) a third active intervention that shared the control group. Participants were followed for 12 months and multiple methods of assessment were used. Compared with the control group, the Harmony@Home group reported an increase in the primary outcome of satisfaction with the parent-child relationship at 3 months' postintervention. Although results are mixed, this study demonstrates how a culturally adaptive community intervention can improve the parental behaviors that serve as protective factors against negative academic and behavioral outcomes for Chinese adolescents.

[Tele-medicine system for high-risk asthmatic patients].

PubMed

Kokubu, F; Suzuki, H; Sano, Y; Kihara, N; Adachi, M

1999-07-01

We have developed a tele-medicine system to monitor the airway status at home for patients with poorly controlled asthma, whereby a nurse provides instructions to individuals via the telephone to help them manage exacerbation under the supervision of their physicians. We examined the effectiveness of this system with a randomized control study. Patients with high hospitalization risk were enrolled in the study by screening patients for those with multiple previous emergency room visits and randomly assigned to either the tele-medicine or control group. After six months of participation in the program, the number of emergency room visits decreased significantly and the activities of daily living were improved in the tele-medicine group. Most of the patients in the tele-medicine group were able to continue measuring and transmitting peak expiratory flow (PEF) value successfully, and at six months had noticed an improvement in PEF. We therefore conclude that the system effectively contributes to the management of poorly controlled asthma. In addition, further consideration suggests that the reduction of emergency room visits may lead to reduction in hospitalization since we found a good correlation between number of emergency room visits and hospitalization from the studies published previously.

Neighborhood Effects in a Behavioral Randomized Controlled Trial

PubMed Central

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

2015-01-01

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

Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trial.

PubMed

Chen, Lifang; Fang, Jianqiao; Ma, Ruijie; Froym, Ronen; Gu, Xudong; Li, Jianhua; Chen, Lina; Xu, Shouyu; Ji, Conghua

2014-06-08

Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke. In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events. This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function. Chinese Clinical Trial Registry ChiCTR-TRC-12001971.

Packet Randomized Experiments for Eliminating Classes of Confounders

PubMed Central

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

2014-01-01

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

A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma.

PubMed

Gómez-Aguayo, Francisco; Paczka, José A; Leñero-Córdova, Rubén; Jiménez-Román, Jesús; Davila-Villarreal, Jaime; Hartleben, Curt; Baiza-Durán, Leopoldo; Olvera-Montaño, Oscar; García-Velez, Francisco; Muñoz-Villegas, Patricia

2018-06-01

The aim of this prospective crossover study was to evaluate the non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by evaluating its efficacy, tolerability and safety in subjects with controlled primary open-angle glaucoma (POAG) previously treated with KOF for at least 2 months. In a prospective, crossover, randomized, double-masked multicenter study, patients previously treated with KOF were randomly assigned to receive either PRO-122 or KOF for 30 days. On day 31, the A sequence changed to KOF, while the B sequence received PRO-122. All patients remained in the protocol for 30 additional days for a total of 60 days. The main efficacy endpoint was maintaining the controlled intraocular pressure (IOP). The safety and tolerability of both products were assessed by the presence of adverse events (AEs), ocular findings, a questionnaire on ocular comfort and the VF-14 index. A total of 51 patients participated. After application of PRO-122 twice a day, its efficacy was demonstrated through maintenance of the controlled IOP in patients previously controlled with KOF. The crossover between PRO-122 and KOF and vice versa, after 30 days of use, did not affect IOP control. PRO-122 was shown not to be inferior to KOF in maintaining IOP at control levels. The safety of both drugs is similar, as neither presented drug-related AEs or differences regarding safety issues. The tolerability of the two medications-evaluated by ocular findings, the questionnaire on ocular comfort and the VF-14 index-was also determined to be similar. The controlled IOP in patients with controlled POAG treated with PRO-122 was maintained both in relation to the initial controlled IOP of the study and when compared with KOF in the B sequence. Finally, the treatment with PRO-122 demonstrated similar safety and tolerability to KOF. Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México). ClinicalTrials.gov identifier: NCT03257813 (registered retrospectively).

Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial.

PubMed

Diederichsen, Søren Zöga; Haugan, Ketil Jørgen; Køber, Lars; Højberg, Søren; Brandes, Axel; Kronborg, Christian; Graff, Claus; Holst, Anders Gaarsdal; Nielsen, Jonas Bille; Krieger, Derk; Svendsen, Jesper Hastrup

2017-05-01

Atrial fibrillation (AF) increases the rate of stroke 5-fold, and AF-related strokes have a poorer prognosis compared with non-AF-related strokes. Atrial fibrillation and stroke constitute an intensifying challenge, and health care organizations are calling for awareness on the topic. Previous studies have demonstrated that AF is often asymptomatic and consequently undiagnosed. The implantable loop recorder (ILR) allows for continuous, long-term electrocardiographic monitoring with daily transmission of arrhythmia information, potentially leading to improvement in AF detection and stroke prevention. The LOOP study is an investigator-initiated, randomized controlled trial with 6,000 participants randomized 3:1 to a control group or to receive an ILR with continuous electrocardiographic monitoring. Participants are identified from Danish registries and are eligible for inclusion if 70years or older and previously diagnosed as having at least one of the following conditions: hypertension, diabetes mellitus, heart failure, or previous stroke. Exclusion criteria include history of AF and current oral anticoagulation treatment. When an AF episode lasting ≥6minutes is detected, oral anticoagulation will be initiated according to guidelines. Expected follow-up is 4years. The primary end point is time to stroke or systemic embolism, whereas secondary end points include time to AF diagnosis and death. The LOOP study will evaluate health benefits and cost-effectiveness of ILR as a screening tool for AF to prevent stroke in patients at risk. Secondary objectives include identification of risk factors for the development of AF and characterization of arrhythmias in the population. The trial holds the potential to influence the future of stroke prevention. Copyright © 2017 Elsevier Inc. All rights reserved.

Electronic prompts significantly increase response rates to postal questionnaires: a randomized trial within a randomized trial and meta-analysis.

PubMed

Clark, Laura; Ronaldson, Sarah; Dyson, Lisa; Hewitt, Catherine; Torgerson, David; Adamson, Joy

2015-12-01

To assess the effectiveness of sending electronic prompts to randomized controlled trial participants to return study questionnaires. A "trial within a trial" embedded within a study determining the effectiveness of chronic obstructive pulmonary disease (DOC) screening on smoking cessation. Those participants taking part in DOC who provided a mobile phone number and/or an electronic mail address were randomized to either receive an electronic prompt or no electronic prompt to return a study questionnaire. The results were combined with two previous studies in a meta-analysis. A total of 437 participants were randomized: 226 to the electronic prompt group and 211 to the control group. A total of 285 (65.2%) participants returned the follow-up questionnaire: 157 (69.5%) in the electronic prompt group and 128 (60.7%) in the control group [difference 8.8%; 95% confidence interval (CI): -0.11%, 17.7%; P = 0.05]. The mean time to response was 23 days in the electronic prompt group and 33 days in the control group (hazard ratio = 1.27; 95% CI: 1.105, 1.47). The meta-analysis of all three studies showed an increase in response rate of 7.1% (95% CI: 0.8%, 13.3%). The use of electronic prompts increased response rates and reduces the time to response. Copyright © 2015 Elsevier Inc. All rights reserved.

Probabilistic DHP adaptive critic for nonlinear stochastic control systems.

PubMed

Herzallah, Randa

2013-06-01

Following the recently developed algorithms for fully probabilistic control design for general dynamic stochastic systems (Herzallah & Káarnáy, 2011; Kárný, 1996), this paper presents the solution to the probabilistic dual heuristic programming (DHP) adaptive critic method (Herzallah & Káarnáy, 2011) and randomized control algorithm for stochastic nonlinear dynamical systems. The purpose of the randomized control input design is to make the joint probability density function of the closed loop system as close as possible to a predetermined ideal joint probability density function. This paper completes the previous work (Herzallah & Káarnáy, 2011; Kárný, 1996) by formulating and solving the fully probabilistic control design problem on the more general case of nonlinear stochastic discrete time systems. A simulated example is used to demonstrate the use of the algorithm and encouraging results have been obtained. Copyright © 2013 Elsevier Ltd. All rights reserved.

Enhancing Risk Detection Among Homeless Youth: A Randomized Clinical Trial of a Promising Pilot Intervention.

PubMed

Bender, Kimberly A; DePrince, Anne; Begun, Stephanie; Hathaway, Jessica; Haffejee, Badiah; Schau, Nicholas

2016-03-02

Homeless youth frequently experience victimization, and youth with histories of trauma often fail to detect danger risks, making them vulnerable to subsequent victimization. The current study describes a pilot test of a skills-based intervention designed to improve risk detection among homeless youth through focusing attention to internal, interpersonal, and environmental cues. Youth aged 18 to 21 years (N = 74) were recruited from a shelter and randomly assigned to receive usual case management services or usual services plus a 3-day manualized risk detection intervention. Pretest and posttest interviews assessed youths' risk detection abilities through vignettes describing risky situations and asking youth to identify risk cues present. Separate 2 (intervention vs. control) × 2 (pretest vs. posttest) mixed ANOVAs found significant interaction effects, as intervention youth significantly improved in overall risk detection compared with control youth. Post hoc subgroup analyses found the intervention had a greater effect for youth without previous experiences of indirect victimization than those with previous indirect victimization experiences. © The Author(s) 2016.

Direct versus Indirect and Individual versus Group Modes of Language Therapy for Children with Primary Language Impairment: Principal Outcomes from a Randomized Controlled Trial and Economic Evaluation

ERIC Educational Resources Information Center

Boyle, James M.; McCartney, Elspeth; O'Hare, Anne; Forbes, John

2009-01-01

Background: Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and…

Framing preventive care messaging and cervical cancer screening in a health-insured population in South Africa: Implications for population-based communication?

PubMed

Adonis, Leegale; Paramanund, Jithen; Basu, Debashis; Luiz, John

2017-09-01

The impact of health message framing on cervical cancer screening uptake is poorly understood. In a prospective randomized control study with 748 females, aged 21-65 years with no Pap smear in the previous 3 years, they randomly received a loss-framed, gain-framed, or neutral health message (control) regarding cervical cancer screening by email. Screening rate in the control group was 9.58 percent (CI: 9.29%-9.87%), 5.71 percent (CI: 5.48%-6.98%) in the gain-framed group, and 8.53 percent (CI: 8.24%-8.81%) in the loss-framed group. Statistically there was no difference between the three screening rates. Framing of health messages may not be a significant consideration when communicating through emails.

Core ADHD Symptom Improvement with Atomoxetine versus Methylphenidate: A Direct Comparison Meta-Analysis

ERIC Educational Resources Information Center

Hazell, Philip L.; Kohn, Michael R.; Dickson, Ruth; Walton, Richard J.; Granger, Renee E.; van Wyk, Gregory W.

2011-01-01

Objective: Previous studies comparing atomoxetine and methylphenidate to treat ADHD symptoms have been equivocal. This noninferiority meta-analysis compared core ADHD symptom response between atomoxetine and methylphenidate in children and adolescents. Method: Selection criteria included randomized, controlled design; duration 6 weeks; and…

Practical Effects of Classwide Mathematics Intervention

ERIC Educational Resources Information Center

VanDerHeyden, Amanda M.; Codding, Robin S.

2015-01-01

The current article presents additional analyses of a classwide mathematics intervention, from a previously reported randomized controlled trial, to offer new information about the treatment and to demonstrate the utility of different types of effect sizes. Multilevel modeling was used to examine treatment effects by race, sex, socioeconomic…

Randomized controlled trial in rural Ethiopia to assess a portable water treatment device.

PubMed

Boisson, Sophie; Schmidt, Wolf-Peter; Berhanu, Tsegahiwot; Gezahegn, Henock; Clasen, Thomas

2009-08-01

We conducted a randomized controlled trial to assess the Lifestraw Personal pipe-style water treatment device among a rural population in Ethiopia. A total of 313 households (including 1516 persons) were randomly assigned either to an intervention group in which each householder received a Lifestraw Personal or a control. Households were visited fortnightly over a five-month intervention period and asked to report any episode of diarrhea during the previous week. A random sample of 160 devices was tested each month to assess the presence of thermotolerant coliforms (TTC) and residual iodine in treated water and to measure flow rate under simulated use. Members of the intervention group had 25% fewer weeks with diarrhea than those of the control group (longitudinal prevalence ratio = 0.75; 95% CI 0.60; 0.95). All 718 filtered water samples were free of TTC, were free of detectable iodine disinfectant, and showed a constant flow rate over time. After the five-month intervention period, 34% of participants reported use of device in the preceding week and 13% reported consistent use. While the device was associated with a 25% reduction in longitudinal prevalence of diarrhea, low levels of use suggest that much of this effect is likely to be attributable to reporting bias that is common in open trials with nonobjective outcomes.

Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

PubMed Central

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-01-01

Aim Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. Method A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Results Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Conclusions Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes. PMID:21197303

Neighborhood effects in a behavioral randomized controlled trial.

PubMed

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

2014-11-01

Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient's CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. Copyright © 2014 Elsevier Ltd. All rights reserved.

Computer access security code system

NASA Technical Reports Server (NTRS)

Collins, Earl R., Jr. (Inventor)

1990-01-01

A security code system for controlling access to computer and computer-controlled entry situations comprises a plurality of subsets of alpha-numeric characters disposed in random order in matrices of at least two dimensions forming theoretical rectangles, cubes, etc., such that when access is desired, at least one pair of previously unused character subsets not found in the same row or column of the matrix is chosen at random and transmitted by the computer. The proper response to gain access is transmittal of subsets which complete the rectangle, and/or a parallelepiped whose opposite corners were defined by first groups of code. Once used, subsets are not used again to absolutely defeat unauthorized access by eavesdropping, and the like.

Prolonged Follow-Up of Patients in the U.S. Multicenter Trial of Ursodeoxycholic Acid for Primary Biliary Cirrhosis

PubMed Central

Combes, Burton; Luketic, Velimir A.; Peters, Marion G.; Zetterman, Rowen K.; Garcia-Tsao, Guadalupe; Munoz, Santiago J.; Lin, Danyu; Flye, Nancy; Carithers, Robert L.

2013-01-01

OBJECTIVE Randomized, double-blind, placebo-controlled trials of ursodeoxycholic acid (UDCA) in patients with primary biliary cirrhosis (PBC) have not demonstrated improvement in survival during the placebo-controlled phases of these trials. Analyses purporting to demonstrate a survival advantage of UDCA are largely dependent on data obtained after the placebo phases were terminated, and placebo-treated patients were offered open-label UDCA. After completion of our 2-yr placebo-controlled trial of UDCA in which we observed no survival benefit for UDCA, we provided the patients with open-label UDCA to see if delay in providing UDCA for 2 yr had any effect on subsequent liver transplantation or death without liver transplantation. METHODS In our previously reported 2-yr placebo-controlled trial, 151 patients with PBC were randomized to receive either UDCA (n = 77) or placebo (n = 74). The number of patients who progressed to liver transplantation or death without transplantation were similar in both the groups, 12 (16%) in the UDCA-treated and 11 (15%) in placebo-treated patients. All the patients were then offered open-label UDCA, with 61 original UDCA and 56 original placebo-treated patients now taking UDCA in an extended open-label phase of the trial. RESULTS No significant differences were observed in the number of patients who underwent liver transplantation or died without liver transplantation in the open-label phase of the trial. Moreover, no difference in the time to these endpoints was seen over the period of observation of as long as 6 yr from the time of initial randomization. CONCLUSIONS Results of open-label extensions of previous conducted placebo-controlled trials of UDCA in PBC leave uncertain whether UDCA impacts significantly on liver transplantation and death without liver transplantation in patients with PBC. PMID:15046215

Effect of Regular Resistance Training on Motivation, Self-Perceived Health, and Quality of Life in Previously Inactive Overweight Women: A Randomized, Controlled Trial.

PubMed

Heiestad, Hege; Rustaden, Anne Mette; Bø, Kari; Haakstad, Lene A H

2016-01-01

Objectives. The aim was to investigate the effects of three different types of resistance training implementation. Design. Randomized controlled trial. Methods. Inactive, overweight women (n = 143), mean BMI 31.3 ± 5.2 kg/m(2), mean age 39.9 ± 10.5 years, were randomized to one of the following groups: A (BodyPump group training), B (individual follow-up by a personal trainer), C (nonsupervised exercise), or D (controls). The intervention included 12 weeks of 45-60 minutes' full-body resistance training three sessions per week. The outcomes in this paper are all secondary outcome measures: exercise motivation, self-perceived health, and quality of life. Results. Adherence averaged 26.1 ± 10.3 of 36 prescribed sessions. After the intervention period, all three training groups (A-C) had better scores on exercise motivation (A = 43.9 ± 19.8, B = 47.6 ± 15.4, C = 48.4 ± 17.8) compared to the control group (D) (26.5 ± 18.2) (p < 0.001). Groups B and C scored better on self-perceived health (B = 1.9 ± 0.8, C = 2.3 ± 0.8), compared to group D (3.0 ± 0.6) (p < 0.001). For quality of life measurement, there was no statistically significant difference between either intervention groups or the control. Conclusions. Resistance training contributed to higher scores in important variables related to exercise motivation and self-perceived health. Low adherence showed that it was difficult to motivate previously inactive, overweight women to participate in regular strength training.

Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial

PubMed Central

Ferrer, Assumpta; Formiga, Francesc; Sanz, Héctor; de Vries, Oscar J; Badia, Teresa; Pujol, Ramón

2014-01-01

Background The purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people, including individuals with cognitive impairment or comorbidities. Methods A randomized, single-blind, parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona). Of 696 referred people who were born in 1924, 328 were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both patients and their primary care providers. Primary outcomes were risk of falling and time until falls. Data analyses were by intention-to-treat. Results Sixty-five (39.6%) subjects in the intervention group and 48 (29.3%) in the control group fell during follow-up. The difference in the risk of falls was not significant (relative risk 1.28, 95% confidence interval [CI] 0.94–1.75). Cox regression models with time from randomization to the first fall were not significant. Cox models for recurrent falls showed that intervention had a negative effect (hazard ratio [HR] 1.46, 95% CI 1.03–2.09) and that functional impairment (HR 1.42, 95% CI 0.97–2.12), previous falls (HR 1.09, 95% CI 0.74–1.60), and cognitive impairment (HR 1.08, 95% CI 0.72–1.60) had no effect on the assessment. Conclusion This multifactorial intervention among octogenarians, including individuals with cognitive impairment or comorbidities, did not result in a reduction in falls. A history of previous falls, disability, and cognitive impairment had no effect on the program among the community-dwelling subjects in this study. PMID:24596458

Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial.

PubMed

Murphy, Patrick; Lee, Kevin; Dubois, Luc; DeRose, Guy; Forbes, Thomas; Power, Adam

2015-11-04

Rates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization. In this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed. The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs. NCT02084017 , March 2014.

Cockroach allergen reduction by cockroach control alone in low-income urban homes: a randomized control trial.

PubMed

Sever, Michelle L; Arbes, Samuel J; Gore, J Chad; Santangelo, Richard G; Vaughn, Ben; Mitchell, Herman; Schal, Coby; Zeldin, Darryl C

2007-10-01

We previously reported significant reductions in cockroach allergen concentrations in urban homes by reducing cockroach infestations. To determine the effectiveness of pest control performed by professional entomologists, compared with commercial companies, in reducing cockroach allergen. This 3-arm randomized controlled trial enrolled 60 cockroach-infested homes in North Carolina. Homes were randomly assigned to a control group or 1 of 2 treatment groups. Treatment 1 had insecticide baits placed by entomologists from North Carolina State University. Treatment 2 received pest control from a randomly assigned commercial company. Vacuumed dust sampling and cockroach trapping were conducted at 0, 6, and 12 months. Dust samples were analyzed by ELISA. In treatment 1 homes, there were significant reductions in geometric mean trap counts compared with control and treatment 2 homes at 12 months. Relative to control, significant 12-month reductions in Bla g 1 were evident in treatment 1 homes at all sampled sites, except bedroom floor. From baseline to month 12, geometric mean Bla g 1 concentrations (U/g) decreased from 64.2 to 5.6 in kitchen, 10.6 to 1.1 in living room, 10.7 to 1.9 on bedroom floor, and 3.6 to 2.3 in bed. Treatment 2 homes showed no significant 12-month allergen reductions versus control. Reductions in Bla g 1 in cockroach-infested homes can be achieved by reducing infestations; however, the magnitude of allergen reduction is dependent on the thoroughness and effectiveness of cockroach eradication efforts. Elimination of cockroaches is an effective method for reducing exposure to cockroach allergen.

Knee osteoarthritis and role for surgical intervention: lessons learned from randomized clinical trials and population-based cohorts.

PubMed

Buchbinder, Rachelle; Richards, Bethan; Harris, Ian

2014-03-01

Over the last decade, there has been increased recognition of the importance of high-quality randomized controlled trials in determining the role of surgery for knee osteoarthritis. This review highlights key findings from the best available studies, and considers whether or not this knowledge has resulted in better evidence-based care. Use of arthroscopy to treat knee osteoarthritis has not declined despite strong evidence-based recommendations that do not sanction its use. A large randomized controlled trial has demonstrated that arthroscopic partial meniscectomy followed by a standardized physical therapy program results in similar improvements in pain and function at 6 and 12 months in comparison to physical therapy alone in patients with knee osteoarthritis and a symptomatic meniscal tear, confirming the findings of two previous trials. Two recent randomized controlled trials have demonstrated that decision aids help people to reach better-informed decisions about total knee arthroplasty. A majority of studies have indicated that for people with obesity the positive results of total knee arthroplasty may be compromised by postoperative complications, particularly infection. More efforts are needed to overcome significant evidence-practice gaps in the surgical management of knee osteoarthritis, particularly arthroscopy. Decision aids are a promising tool.

Examining the Efficacy of the Modified Story Memory Technique (mSMT) in Persons With TBI Using Functional Magnetic Resonance Imaging (fMRI): The TBI-MEM Trial.

PubMed

Chiaravalloti, Nancy D; Dobryakova, Ekaterina; Wylie, Glenn R; DeLuca, John

2015-01-01

New learning and memory deficits are common following traumatic brain injury (TBI). Yet few studies have examined the efficacy of memory retraining in TBI through the most methodologically vigorous randomized clinical trial. Our previous research has demonstrated that the modified Story Memory Technique (mSMT) significantly improves new learning and memory in multiple sclerosis. The present double-blind, placebo-controlled, randomized clinical trial examined changes in cerebral activation on functional magnetic resonance imaging following mSMT treatment in persons with TBI. Eighteen individuals with TBI were randomly assigned to treatment (n = 9) or placebo (n = 9) groups. Baseline and follow-up functional magnetic resonance imaging was collected during a list-learning task. Significant differences in cerebral activation from before to after treatment were noted in regions belonging to the default mode network and executive control network in the treatment group only. Results are interpreted in light of these networks. Activation differences between the groups likely reflect increased use of strategies taught during treatment. This study demonstrates a significant change in cerebral activation resulting from the mSMT in a TBI sample. Findings are consistent with previous work in multiple sclerosis. Behavioral interventions can show significant changes in the brain, validating clinical utility.

Moderate intensity exercise as an adjunct to standard smoking cessation treatment for women: a pilot study.

PubMed

Williams, David M; Whiteley, Jessica A; Dunsiger, Shira; Jennings, Ernestine G; Albrecht, Anna E; Ussher, Michael H; Ciccolo, Joseph T; Parisi, Alfred F; Marcus, Bess H

2010-06-01

Previous randomized controlled trials have not supported moderate intensity exercise as an efficacious adjunct to smoking cessation treatments for women; however, compliance with exercise programs in these studies has been poor. The purpose of this pilot study was to estimate the effects of moderate intensity exercise on smoking cessation outcomes under optimal conditions for exercise program compliance. Sixty previously sedentary, healthy, female smokers were randomized to an 8-week program consisting of brief baseline smoking cessation counseling and the nicotine patch plus either 150 min/week of moderate intensity exercise or contact control. Participants attended a median of 86.4% and 95.5% of prescribed exercise/control sessions, respectively. There was a moderate, though statistically nonsignificant, effect of exercise at post-treatment for objectively verified 7-day point prevalence abstinence (48.3% vs. 23.3%; OR = 3.07, 95% CI: 0.89-11.07) and prolonged abstinence (34.5% vs. 20.0%; OR = 2.11, 95% CI: 0.56-8.32). Effects were attenuated when controlling for potential confounders, and after a 1-month, no-treatment period. The findings provide a preliminary indication that, given adequate compliance, moderate intensity exercise may enhance short-term smoking cessation outcomes for women; however, a larger trial is warranted. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

34 CFR 200.89 - MEP allocations; Re-interviewing; Eligibility documentation; and Quality control.

Code of Federal Regulations, 2011 CFR

2011-07-01

... determinations being tested) trained to conduct personal interviews and to understand and apply program... child eligibility determinations through the re-interview of a randomly selected sample of children previously identified as migratory. In conducting these re-interviews, an SEA must— (i) Use, at least once...

34 CFR 200.89 - MEP allocations; Re-interviewing; Eligibility documentation; and Quality control.

Code of Federal Regulations, 2010 CFR

2010-07-01

... determinations being tested) trained to conduct personal interviews and to understand and apply program... child eligibility determinations through the re-interview of a randomly selected sample of children previously identified as migratory. In conducting these re-interviews, an SEA must— (i) Use, at least once...

Randomized controlled pilot trial of naloxone‐on‐release to prevent post‐prison opioid overdose deaths

PubMed Central

Parmar, Mahesh K. B.; Strang, John; Choo, Louise; Meade, Angela M.

2016-01-01

Abstract Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug‐related death soon after release from prison. The NALoxone InVEstigation (N‐ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone‐on‐release (NOR) to eligible prisoners in England. Design. Parallel‐group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre‐randomization, release due within 3 months and more than 6 months since previous N‐ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single ‘rescue’ injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self‐questionnaires (RPSQs: 207), NOR‐carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70–74%]; 218 RPSQs were received; NOR‐carriage (95% CI = 63–79%) and overdose presence (95% CI = 75–84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one‐third of NOR administrations were to the ex‐prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take‐home emergency naloxone prior to prison release may be a life‐saving interim measure to prevent heroin overdose deaths among ex‐prisoners and the wider population. PMID:27776382

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

PubMed

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

2016-01-01

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

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

PubMed Central

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

2016-01-01

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

The effects of testosterone on body composition in obese men are not sustained after cessation of testosterone treatment.

PubMed

Ng Tang Fui, Mark; Hoermann, Rudolf; Zajac, Jeffrey D; Grossmann, Mathis

2017-10-01

Testosterone treatment in obese dieting men augments the diet-associated loss of fat mass, but protects against loss of lean mass. We assessed whether body composition changes are maintained following withdrawal of testosterone treatment. We conducted a prespecified double-blind randomized placebo-controlled observational follow-up study of a randomized controlled trial (RCT). Participants were men with baseline obesity (body mass index >30 kg/m 2 ) and a repeated total testosterone level <12 nmol/L, previously enrolled in a 56-week testosterone treatment trial combined with a weight loss programme. Main outcome measures were mean adjusted differences (MAD) (95% confidence interval), in body composition between testosterone- and placebo-treated men at the end of the observation period. Of the 100 randomized men, 82 completed the RCT and 64 the subsequent observational study. Median [IQR] observation time after completion of the RCT was 82 weeks [74; 90] in men previously receiving testosterone (cases) and 81 weeks [67;91] in men previously receiving placebo (controls), P=.51. At the end of the RCT, while losing similar amounts of weight, cases had, compared to controls, lost more fat mass, MAD -2.9 kg (-5.7, -0.2), P=.04, but had lost less lean mass MAD 3.4 kg (1.3, 5.5), P=.002. At the end of the observation period, the former between-group differences in fat mass, MAD -0.8 kg (-3.6, 2.0), P=1.0, in lean mass, MAD -1.3 kg (-3.0, 0.5), P=.39, and in appendicular lean mass, MAD -0.1 kg/m 2 (-0.3, 0.1), P=.45, were no longer apparent. During observation, cases lost more lean mass, MAD -3.7 kg (-5.5, -1.9), P=.0005, and appendicular lean mass, MAD -0.5 kg/m 2 (-0.8, -0.3), P<.0001 compared to controls. The favourable effects of testosterone on body composition in men subjected to a concomitant weight loss programme were not maintained at 82 weeks after testosterone treatment cessation. © 2017 John Wiley & Sons Ltd.

Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study.

PubMed

Essebag, Vidal; Verma, Atul; Healey, Jeff S; Krahn, Andrew D; Kalfon, Eli; Coutu, Benoit; Ayala-Paredes, Felix; Tang, Anthony S; Sapp, John; Sturmer, Marcio; Keren, Arieh; Wells, George A; Birnie, David H

2016-03-22

The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma. The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection. The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection. The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk. CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Effect of endometrial biopsy on intrauterine insemination outcome in controlled ovarian stimulation cycle.

PubMed

Wadhwa, Leena; Pritam, Amrita; Gupta, Taru; Gupta, Sangeeta; Arora, Sarika; Chandoke, Rajkumar

2015-01-01

The objective was to evaluate the effect of endometrial biopsy (EB) on intrauterine insemination (IUI) outcome in controlled ovarian stimulation (COS) cycle. Prospective randomized control study. Tertiary care center. A total of 251 subjects were enrolled in the study. Subjects undergoing COS with IUI were randomly allocated into three groups. Group A: EB was taken between D19 and 24 of the spontaneous menstrual cycles that precedes the fertility treatment and IUI, which was done in next cycle (n = 86). Group B: EB was taken before D6 of the menstrual cycle, and fertility treatment and IUI was done in the same cycle (n = 90). Group C: (control group) no EB in previous 3 cycle (n = 75). Clinical pregnancy rate (CPR). Clinical pregnancy rate was 19.77%, 31.11%, and 9.3% for Group A, Group B, and Group C, respectively. The results show a highly significant value for the paired t-test of intervention Group B and control Group C of the cases (P = 0.000957). CPR was maximum after first cycle of ovulation induction and IUI following EB scratch in both Groups A and in Group B (P < 0.001). Endometrial biopsy done in early follicular phase in the same cycle of stimulation with IUI gives better CPR as compared with EB done in the luteal phase of the previous cycle.

A scaling law for random walks on networks

PubMed Central

Perkins, Theodore J.; Foxall, Eric; Glass, Leon; Edwards, Roderick

2014-01-01

The dynamics of many natural and artificial systems are well described as random walks on a network: the stochastic behaviour of molecules, traffic patterns on the internet, fluctuations in stock prices and so on. The vast literature on random walks provides many tools for computing properties such as steady-state probabilities or expected hitting times. Previously, however, there has been no general theory describing the distribution of possible paths followed by a random walk. Here, we show that for any random walk on a finite network, there are precisely three mutually exclusive possibilities for the form of the path distribution: finite, stretched exponential and power law. The form of the distribution depends only on the structure of the network, while the stepping probabilities control the parameters of the distribution. We use our theory to explain path distributions in domains such as sports, music, nonlinear dynamics and stochastic chemical kinetics. PMID:25311870

An instrumental variable random-coefficients model for binary outcomes

PubMed Central

Chesher, Andrew; Rosen, Adam M

2014-01-01

In this paper, we study a random-coefficients model for a binary outcome. We allow for the possibility that some or even all of the explanatory variables are arbitrarily correlated with the random coefficients, thus permitting endogeneity. We assume the existence of observed instrumental variables Z that are jointly independent with the random coefficients, although we place no structure on the joint determination of the endogenous variable X and instruments Z, as would be required for a control function approach. The model fits within the spectrum of generalized instrumental variable models, and we thus apply identification results from our previous studies of such models to the present context, demonstrating their use. Specifically, we characterize the identified set for the distribution of random coefficients in the binary response model with endogeneity via a collection of conditional moment inequalities, and we investigate the structure of these sets by way of numerical illustration. PMID:25798048

A scaling law for random walks on networks

NASA Astrophysics Data System (ADS)

Perkins, Theodore J.; Foxall, Eric; Glass, Leon; Edwards, Roderick

2014-10-01

The dynamics of many natural and artificial systems are well described as random walks on a network: the stochastic behaviour of molecules, traffic patterns on the internet, fluctuations in stock prices and so on. The vast literature on random walks provides many tools for computing properties such as steady-state probabilities or expected hitting times. Previously, however, there has been no general theory describing the distribution of possible paths followed by a random walk. Here, we show that for any random walk on a finite network, there are precisely three mutually exclusive possibilities for the form of the path distribution: finite, stretched exponential and power law. The form of the distribution depends only on the structure of the network, while the stepping probabilities control the parameters of the distribution. We use our theory to explain path distributions in domains such as sports, music, nonlinear dynamics and stochastic chemical kinetics.

A scaling law for random walks on networks.

PubMed

Perkins, Theodore J; Foxall, Eric; Glass, Leon; Edwards, Roderick

2014-10-14

The dynamics of many natural and artificial systems are well described as random walks on a network: the stochastic behaviour of molecules, traffic patterns on the internet, fluctuations in stock prices and so on. The vast literature on random walks provides many tools for computing properties such as steady-state probabilities or expected hitting times. Previously, however, there has been no general theory describing the distribution of possible paths followed by a random walk. Here, we show that for any random walk on a finite network, there are precisely three mutually exclusive possibilities for the form of the path distribution: finite, stretched exponential and power law. The form of the distribution depends only on the structure of the network, while the stepping probabilities control the parameters of the distribution. We use our theory to explain path distributions in domains such as sports, music, nonlinear dynamics and stochastic chemical kinetics.

VAGINAL PROGESTERONE VERSUS CERVICAL CERCLAGE FOR THE PREVENTION OF PRETERM BIRTH IN WOMEN WITH A SONOGRAPHIC SHORT CERVIX, SINGLETON GESTATION, AND PREVIOUS PRETERM BIRTH: A SYSTEMATIC REVIEW AND INDIRECT COMPARISON META-ANALYSIS

PubMed Central

CONDE-AGUDELO, Agustin; ROMERO, Roberto; NICOLAIDES, Kypros; CHAIWORAPONGSA, Tinnakorn; O'BRIEN, John M.; CETINGOZ, Elcin; DA FONSECA, Eduardo; CREASY, George; SOMA-PILLAY, Priya; FUSEY, Shalini; CAM, Cetin; ALFIREVIC, Zarko; HASSAN, Sonia S.

2012-01-01

OBJECTIVE No randomized controlled trial has directly compared vaginal progesterone and cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix in the midtrimester, singleton gestation, and previous spontaneous preterm birth. We performed an indirect comparison of vaginal progesterone versus cerclage, using placebo/no cerclage as the common comparator. STUDY DESIGN Adjusted indirect meta-analysis of randomized controlled trials. RESULTS Four studies evaluating vaginal progesterone versus placebo (158 patients) and five evaluating cerclage versus no cerclage (504 patients) were included. Both interventions were associated with a statistically significant reduction in the risk of preterm birth <32 weeks of gestation and composite perinatal morbidity and mortality compared with placebo/no cerclage. Adjusted indirect meta-analyses did not show statistically significant differences between vaginal progesterone and cerclage in reducing preterm birth or adverse perinatal outcomes. CONCLUSION Based on state-of-the-art methodology for indirect comparisons, either vaginal progesterone or cerclage are equally efficacious in the prevention of preterm birth in women with a sonographic short cervix in the midtrimester, singleton gestation, and previous preterm birth. The selection of the optimal treatment may depend upon adverse events, cost and patient/clinician preferences. PMID:23157855

A Cognitive Behavioral Smoking Abstinence Intervention for Adults with Chronic Pain: A Randomized Controlled Pilot Trial

PubMed Central

Hooten, W. Michael; Townsend, Cynthia O.; Hays, J. Taylor; Ebnet, Kaye L.; Gauvin, Thomas R.; Gehin, Jessica M.; Laures, Heidi J.; Patten, Christi A.; Warner, David O.

2015-01-01

Current evidence suggests it may be difficult for patients with chronic pain to quit smoking and, based on previous formative work, a 7-session individual and group-based cognitive behavioral (CB) intervention was developed. The primary aim of this randomized controlled pilot trial was to test the hypothesis that abstinence at month 6 would be greater among patients with chronic pain who received the CB intervention compared to a control condition. Upon admission to a 3-week interdisciplinary pain treatment (IPT) program, patients were randomized to receive the CB intervention (n = 30) or the control condition (n = 30). The 7-day point prevalence of self-reported smoking status was assessed at week 3 (upon completion of the 3-week IPT program) and at month 6 in an intent-to-treat analysis. At week 3, 30% (n=9) of patients in the CB condition were abstinent from smoking compared to 10% (n=3) in the control group (P=.104). At month 6, 20% (n=6) of patients who received the CB intervention were abstinent compared to none in the control group (P=.024). At week 3, a significant group by time interaction effect was found where the CB patients experienced greater improvements in self-efficacy from baseline compared to the control group (P=.002). A greater proportion of patients randomized to the CB group completed the IPT program (P=.052). The findings of this pilot trial suggest that integration of a CB-based smoking abstinence intervention into ongoing pain therapy may be an effective treatment for smokers with chronic pain. PMID:24333035

Tubal anastomosis after previous sterilization: a systematic review.

PubMed

van Seeters, Jacoba A H; Chua, Su Jen; Mol, Ben W J; Koks, Carolien A M

2017-05-01

Female sterilization is one of the most common contraceptive methods. A small number of women, however, opt for reversal of sterilization procedures after they experience regret. Procedures can be performed by laparotomy or laparoscopy, with or without robotic assistance. Another commonly utilized alternative is IVF. The choice between surgery and IVF is often influenced by reimbursement politics for that particular geographic location. We evaluated the fertility outcomes of different surgical methods available for the reversal of female sterilization, compared these to IVF and assessed the prognostic factors for success. Two search strategies were employed. Firstly, we searched for randomized and non-randomized clinical studies presenting fertility outcomes of sterilization reversal up to July 2016. Data on the following outcomes were collected: pregnancy rate, ectopic pregnancy rate, cost of the procedure and operative time. Eligible study designs included prospective or retrospective studies, randomized controlled trials, cohort studies, case-control studies and case series. No age restriction was applied. Exclusion criteria were patients suffering from tubal infertility from any other reason (e.g. infection, endometriosis and adhesions from previous surgery) and studies including <10 participants. The following factors likely to influence the success of sterilization reversal procedures were then evaluated: female age, BMI and duration and method of sterilization. Secondly, we searched for randomized and non-randomized clinical studies that compared reversal of sterilization to IVF and evaluated them for pregnancy outcomes and cost effectiveness. We included 37 studies that investigated a total of 10 689 women. No randomized controlled trials were found. Most studies were retrospective cohort studies of a moderate quality. The pooled pregnancy rate after sterilization reversal was 42-69%, with heterogeneity seen from the different methods utilized. The reported ectopic pregnancy rate was 4-8%. The only prognostic factor affecting the chance of conception was female age. The surgical approach (i.e. laparotomy [microscopic], laparoscopy or robotic) had no impact on the outcome, with the exception of the macroscopic laparotomic technique, which had inferior results and is not currently utilized. For older women, IVF could be a more cost-effective alternative for the reversal of sterilization. However, direct comparative data are lacking and a cut-off age cannot be stated. In sterilized women who suffer regret, surgical tubal re-anastomosis is an effective treatment, especially in younger women. However, there is a need for randomized controlled trials comparing the success rates and costs of surgical reversal with IVF. © 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

Previous history of tuberculosis is associated with rheumatoid arthritis.

PubMed

Shen, T-C; Lin, C-L; Wei, C-C; Chen, C-H; Tu, C-Y; Hsia, T-C; Shih, C-M; Hsu, W-H; Chung, C-J; Sung, F-C; Kao, C-H

2015-11-01

Previous studies have suggested that mycobacterial infections could trigger autoimmune diseases, including rheumatoid arthritis (RA). To explore the association between previous tuberculosis (TB) and RA. We conducted a case-control study using data obtained from the National Health Insurance (NHI) system of Taiwan. We identified 26 535 adults with RA from 2002 to 2011, with the date of diagnosis as the index date. This number was randomly selected and frequency-matched four times by age, sex and the year of index date from among non-RA individuals. Odds ratios (ORs) of RA were calculated for associations with TB. Compared with controls, RA patients had a crude OR of 1.77 for TB (95%CI 1.61-1.94). The strength of the association between RA and TB remained at the same level after controlling for other potential risk factors (adjusted OR 1.73, 95%CI 1.57-1.90), although RA patients tended to have a higher prevalence of hypertension, coronary artery disease and kidney disease. TB was much more prevalent in RA patients than in control subjects. Prospective cohort studies are required to establish a causal relationship between previous TB and RA.

Mindfulness-based cognitive therapy may reduce thought suppression in previously suicidal participants: findings from a preliminary study.

PubMed

Hepburn, Silvia R; Crane, Catherine; Barnhofer, Thorsten; Duggan, Danielle S; Fennell, Melanie J V; Williams, J Mark G

2009-06-01

Thought suppression is a strategy aimed at mental control that may paradoxically increase the frequency of unwanted thoughts. This preliminary study examined effects of mindfulness-based cognitive therapy (MBCT) on thought suppression and depression in individuals with past depression and suicidality. In a randomized controlled trial design, 68 participants were allocated to an MBCT group or a treatment-as-usual waitlist control. Measures of thought suppression and depression were taken pre- and post-treatment. MBCT did not reduce thought suppression as measured by the White Bear Suppression Inventory, but significantly reduced self-reported attempts to suppress in the previous week. Preliminary evidence suggests that MBCT for suicidality may reduce thought suppression, but differential effects on thought suppression measures warrant further studies.

Replication of a Prospective Randomized Controlled Trial of Resource Facilitation to Improve Return to Work and School After Brain Injury.

PubMed

Trexler, Lance E; Parrott, Devan R; Malec, James F

2016-02-01

To determine the extent to which previous findings on the effectiveness of resource facilitation to impact return to work and school could be replicated. Randomized controlled trial. Outpatient rehabilitation clinic. Outpatients with acquired brain injury (N=44). Fifteen months of resource facilitation services. A revised version of the Vocational Independence Scale and the Mayo-Portland Adaptability Inventory-4 Participation Index. Participants randomized to the resource facilitation group demonstrated a significant advantage in terms of rate and timing of return to productive community-based work relative to control participants. When examining only return to competitive work (and not return to school), 69% of the resource facilitation group was able to return compared with 50% of the control participants. Analyses of measures of participation in household and community activities revealed that both groups improved significantly over the 15-month study period, but no significant advantage for either group was demonstrated. This study replicates the positive impact of resource facilitation in improving productive community-based activity, including competitive employment and volunteering in the community. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Evaluating Psychosocial and Behavioral Mechanisms of Change in a Tailored Communication Intervention

ERIC Educational Resources Information Center

Elder, John P.; Ayala, Guadalupe X.; Slymen, Donald J.; Arredondo, Elva M.; Campbell, Nadia R.

2009-01-01

This study examined the impact of a tailored nutrition intervention at 3 and 6 months postintervention. In all, 357 Latinas were randomly assigned to one of three conditions: (1) a control condition comprised of previously developed Spanish language targeted materials, (2) tailored print materials, or (3) tailored print materials accompanied by…

Development of Children at Risk for Adverse Outcomes Participating in Early Intervention in Developing Countries: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Wallander, Jan L.; Bann, Carla M.; Biasini, Fred J.; Goudar, Shivaprasad S.; Pasha, Omrana; Chomba, Elwyn; McClure, Elizabeth; Carlo, Waldemar A.

2014-01-01

Background: Previous research has indicated positive effects of early developmental intervention (EDI) on the development of children in developing countries. Few studies, however, have examined longitudinally when differential treatment effects may be observed and whether differential outcomes are associated with exposure to different risk…

Self-Management Education for Rehabilitation Inpatients Suffering from Inflammatory Bowel Disease: A Cluster-Randomized Controlled Trial

ERIC Educational Resources Information Center

Reusch, A.; Weiland, R.; Gerlich, C.; Dreger, K.; Derra, C.; Mainos, D.; Tuschhoff, T.; Berding, A.; Witte, C.; Kaltz, B.; Faller, H.

2016-01-01

Although inflammatory bowel disease (IBD) affects patients' psychological well-being, previous educational programs have failed to demonstrate effects on psychosocial outcomes and quality of life. Therefore, we developed a group-based psychoeducational program that combined provision of both medical information and psychological self-management…

Implementing Cognitive Behavioral Therapy for Chronic Fatigue Syndrome in a Mental Health Center: A Benchmarking Evaluation

ERIC Educational Resources Information Center

Scheeres, Korine; Wensing, Michel; Knoop, Hans; Bleijenberg, Gijs

2008-01-01

Objective: This study evaluated the success of implementing cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS) in a representative clinical practice setting and compared the patient outcomes with those of previously published randomized controlled trials (RCTs) of CBT for CFS. Method: The implementation interventions were the…

Examining the Relationship between Family Meal Frequency and Individual Dietary Intake: Does Family Cohesion Play a Role?

ERIC Educational Resources Information Center

Welsh, Ericka M.; French, Simone A.; Wall, Melanie

2011-01-01

Objective: To confirm previously reported associations between family meal frequency and dietary intake, and to examine family cohesion as a potential mediator of this relationship. Design: Cross-sectional observational study. Data collected at baseline via questionnaire. Setting: Randomized, controlled household weight gain prevention trial.…

Just-So Stories: Vaccines, Autism, and the Single-Bullet Disorder

ERIC Educational Resources Information Center

Bearman, Peter

2010-01-01

When should people believe in science, especially in scientific explanations of the causes of health, ill or otherwise? One line of argumentation is that scientific evidence based in robust ecological data, supported by previously tested animal or biological models or double-blinded randomized control trials trumps intuition or just plain "common…

JPL CMOS Active Pixel Sensor Technology

NASA Technical Reports Server (NTRS)

Fossum, E. R.

1995-01-01

This paper will present the JPL-developed complementary metal- oxide-semiconductor (CMOS) active pixel sensor (APS) technology. The CMOS APS has achieved performance comparable to charge coupled devices, yet features ultra low power operation, random access readout, on-chip timing and control, and on-chip analog to digital conversion. Previously published open literature will be reviewed.

The Evolution, Design and Implementation of the Minds in Motion Curriculum

ERIC Educational Resources Information Center

Cottone, Elizabeth; Chen, Wei-Bing; Brock, Laura

2013-01-01

Building on the empirical work of the previous two studies, this paper describes the development of the Minds In Motion curriculum (MIM), as well as the setting and circumstances of a randomized controlled trial conducted to evaluate this intervention. Throughout this paper the authors emphasize the benefits and challenges of assembling an…

Scale-Up of Safe & Civil Schools' Model for School-Wide Positive Behavioral Interventions and Supports

ERIC Educational Resources Information Center

Smolkowski, Keith; Strycker, Lisa; Ward, Bryce

2016-01-01

This study evaluated the scale-up of a Safe & Civil Schools "Foundations: Establishing Positive Discipline Policies" positive behavioral interventions and supports initiative through 4 years of "real-world" implementation in a large urban school district. The study extends results from a previous randomized controlled trial…

Inside the Black Box: Examining Mediators and Moderators of a Middle School Science Intervention

ERIC Educational Resources Information Center

Desimone, Laura M.; Hill, Kirsten Lee

2017-01-01

We use data from a randomized controlled trial of a middle school science intervention to explore the causal mechanisms by which the intervention produced previously documented gains in student achievement. Our study finds that implementation fidelity, operationalized as a measure of the frequency of implementation of the cognitive science…

Effect of decision aid for breast cancer prevention on decisional conflict in women with a BRCA1 or BRCA2 mutation: a multisite, randomized, controlled trial.

PubMed

Metcalfe, Kelly A; Dennis, Cindy-Lee; Poll, Aletta; Armel, Susan; Demsky, Rochelle; Carlsson, Lindsay; Nanda, Sonia; Kiss, Alexander; Narod, Steven A

2017-03-01

Women with a BRCA1 or BRCA2 mutation are at high risk for breast cancer and must make important decisions about breast cancer prevention and screening. In the current study, we report a multisite, randomized, controlled trial evaluating the effectiveness of a decision aid for breast cancer prevention in women with a BRCA mutation with no previous diagnosis of cancer. Within 1 month of receiving a positive BRCA result, women were randomized to receive either usual care (control group) or decision aid (intervention group). Participants were followed at 3, 6, and 12 months; were asked about preventive measures; and completed standardized questionnaires assessing decision making and psychosocial functioning. One hundred fifty women were randomized. Mean cancer-related distress scores were significantly lower in the intervention group compared with the control group at 6 months (P = 0.01) and at 12 months postrandomization (P = 0.05). Decisional conflict scores declined over time for both groups and at no time were there statistical differences between the two groups. The decision aid for breast cancer prevention in women with a BRCA1 or BRCA2 mutation is effective in significantly decreasing cancer-related distress within the year following receipt of positive genetic test results.Genet Med 19 3, 330-336.

Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

PubMed

Posser, Simone Regina; Callegaro, Carine Cristina; Beltrami-Moreira, Marina; Moreira, Leila Beltrami

2016-08-02

Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

Theory-based behavioral intervention increases self-reported physical activity in South African men: a cluster-randomized controlled trial.

PubMed

Jemmott, John B; Jemmott, Loretta S; Ngwane, Zolani; Zhang, Jingwen; Heeren, G Anita; Icard, Larry D; O'Leary, Ann; Mtose, Xoliswa; Teitelman, Anne; Carty, Craig

2014-07-01

To determine whether a health-promotion intervention increases South African men's adherence to physical-activity guidelines. We utilized a cluster-randomized controlled trial design. Eligible clusters, residential neighborhoods near East London, South Africa, were matched in pairs. Within randomly selected pairs, neighborhoods were randomized to theory-based, culturally congruent health-promotion intervention encouraging physical activity or attention-matched HIV/STI risk-reduction control intervention. Men residing in the neighborhoods and reporting coitus in the previous 3 months were eligible. Primary outcome was self-reported individual-level adherence to physical-activity guidelines averaged over 6-month and 12-month post-intervention assessments. Data were collected in 2007-2010. Data collectors, but not facilitators or participants, were blind to group assignment. Primary outcome intention-to-treat analysis included 22 of 22 clusters and 537 of 572 men in the health-promotion intervention and 22 of 22 clusters and 569 of 609 men in the attention-control intervention. Model-estimated probability of meeting physical-activity guidelines was 51.0% in the health-promotion intervention and 44.7% in attention-matched control (OR=1.34; 95% CI, 1.09-1.63), adjusting for baseline prevalence and clustering from 44 neighborhoods. A theory-based culturally congruent intervention increased South African men's self-reported physical activity, a key contributor to deaths from non-communicable diseases in South Africa. ClinicalTrials.gov Identifier: NCT01490359. Copyright © 2014 Elsevier Inc. All rights reserved.

Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized controlled trial

PubMed Central

Michopoulos, Vasiliki; Mancini, Fulvia; Loucks, Tammy L.; Berga, Sarah L.

2013-01-01

Objective To determine whether cognitive behavior therapy (CBT), which we previously showed restored ovarian function in women with functional hypothalamic amenorrhea (FHA), also ameliorated hypercortisolemia and improved other neuroendocrine and metabolic concomitants of in FHA. Design Randomized controlled trial. Intervention CBT vs. observation. Setting Clinical research center at an academic medical university. Patient(s) Seventeen women with FHA were randomized either to CBT or observation. Main Outcome Measure(s) Circulatory concentrations of cortisol, leptin, TSH, total and free thyronine (T3), and total and free thyroxine (T4) before and immediately after completion of CBT or observation. Each woman served as her own control. Results CBT but not observation reduced cortisol levels in women with FHA. There were no changes in cortisol, leptin, TSH, T3, or T4 levels in women randomized to observation. Women treated with CBT showed increased levels of leptin and TSH, while levels of T3 and T4 remained unchanged. Conclusions CBT ameliorated hypercortisolism and improved neuroendocrine and metabolic concomitants of FHA while observation did not. We conclude that a cognitive, nonpharmacological approach aimed at alleviating problematic attitudes not only restored ovarian activity but also improved neuroendocrine and metabolic function in women with FHA. PMID:23507474

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

PubMed

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

2017-08-01

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

Impact of Free Glasses and a Teacher Incentive on Children's Use of Eyeglasses: A Cluster-Randomized Controlled Trial.

PubMed

Yi, Hongmei; Zhang, Haiqing; Ma, Xiaochen; Zhang, Linxiu; Wang, Xiuqin; Jin, Ling; Naidoo, Kovin; Minto, Hasan; Zou, Haidong; Lu, Lina; Rozelle, Scott; Congdon, Nathan

2015-11-01

To study the effect of free glasses combined with teacher incentives on in-school glasses wear among Chinese urban migrant children. Cluster-randomized controlled trial. Children with visual acuity (VA) ≤6/12 in either eye owing to refractive error in 94 randomly chosen primary schools underwent randomization by school to receive free glasses, education on their use, and a teacher incentive (Intervention), or glasses prescriptions only (Control). Intervention group teachers received a tablet computer if ≥80% of children given glasses wore them during unannounced visits 6 weeks and 6 months (main outcome) after intervention. Among 4376 children, 728 (16.7%, mean age 10.9 years, 51.0% boys) met enrollment criteria and were randomly allocated, 358 (49.2%, 47 schools) to Intervention and 370 (50.8%, 47 schools) to Control. Among these, 693 children (95.2%) completed the study and underwent analysis. Spectacle wear was significantly higher at 6 months among Intervention children (Observed [main outcome]: 68.3% vs 23.9%, adjusted odds ratio [OR] = 11.5, 95% confidence interval [CI] 5.91-22.5, P < .001; Self-reported: 90.6% vs 32.1%, OR = 43.7, 95% CI = 21.7-88.5, P < .001). Other predictors of observed wear at 6 months included baseline spectacle wear (P < .001), uncorrected VA <6/18 (P = .01), and parental spectacle wear (P = .02). The 6-month observed wear rate was only 41% among similar-aged children provided free glasses in our previous trial without teacher incentives. Free spectacles and teacher incentives maintain classroom wear in the large majority of children needing glasses over a school year. Low wear among Control children demonstrates the need for interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

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

2015-08-28

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

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.

Reconfigurable Antenna Aperture with Optically Controlled GeTe-Based RF Switches

DTIC Science & Technology

2015-03-31

duration (~100ns) but high amplitude raises the material’s temperature above the melting point . As a liquid, the atoms are randomly distributed...100ns, there is sufficient optical energy to heat and melt a 100nm thick GeTe PCM area of approximately 3µm 2 . Figure 3. Optimum PCM area...which tracks well with previously published thin film heater model [9]. Figure 4. Validation of Melt /Quench Thermal Model Optical Control: The

Particle chaos and pitch angle scattering

NASA Technical Reports Server (NTRS)

Burkhart, G. R.; Dusenbery, P. B.; Speiser, T. W.

1995-01-01

Pitch angle scattering is a factor that helps determine the dawn-to-dusk current, controls particle energization, and it has also been used as a remote probe of the current sheet structure. Previous studies have interpreted their results under the exception that randomization will be greatest when the ratio of the two timescales of motion (gyration parallel to and perpendicular to the current sheet) is closet to one. Recently, the average expotential divergence rate (AEDR) has been calculated for particle motion in a hyperbolic current sheet (Chen, 1992). It is claimed that this AEDR measures the degree of chaos and therefore may be thought to measure the randomization. In contrast to previous expectations, the AEDR is not maximized when Kappa is approximately equal to 1 but instead increases with decreasing Kappa. Also contrary to previous expectations, the AEDR is dependent upon the parameter b(sub z). In response to the challenge to previous expectations that has been raised by this calculation of the AEDR, we have investigated the dependence of a measure of particle pitch angle scattering on both the parameters Kappa and b(sub z). We find that, as was previously expected, particle pitch angle scattering is maximized near Kappa = 1 provided that Kappa/b(sub z) greater than 1. In the opposite regime, Kappa/b(sub z) less than 1, we find that particle pitch angle scattering is still largest when the two timescales are equal, but the ratio of the timescales is proportional to b(sub z). In this second regime, particle pitch angle scattering is not due to randomization, but is instead due to a systematic pitch angle change. This result shows that particle pitch angle scattering need not be due to randomization and indicates how a measure of pitch angle scattering can exhibit a different behavior than a measure of chaos.

Outcome evaluation of a high school smoking reduction intervention based on extracurricular activities.

PubMed

Brown, K Stephen; Cameron, Roy; Madill, Cheryl; Payne, M Elizabeth; Filsinger, Stephanie; Manske, Stephen R; Best, J Allan

2002-11-01

An outcome evaluation of a high school tobacco control intervention using extracurricular activities developed by teachers and students is reported. Eligible subjects (n = 3,028) had participated in a randomized trial of an elementary school smoking prevention curriculum. Their high schools were matched in pairs; one school in each pair was randomly assigned to the intervention condition, the second to a "usual-care" control condition. Data were collected at the end of Grades 9 and 10. For Grade 8 never smokers, regular smoking rates were significantly lower for males from intervention schools (9.8 vs 16.2%, P = 0.02) at the end of Grade 10. There were no significant differences among Grade 10 smoking rates for females, or for students of either gender with previous smoking experience in Grade 8. The extracurricular activities approach to tobacco control is practical to implement and has promise.

Improving influenza vaccination rates in the workplace: a randomized trial.

PubMed

Nowalk, Mary Patricia; Lin, Chyongchiou J; Toback, Seth L; Rousculp, Matthew D; Eby, Charles; Raymund, Mahlon; Zimmerman, Richard K

2010-03-01

To minimize absenteeism resulting from influenza, employers frequently offer on-site influenza vaccination to employees. Yet the level of uptake of vaccine is low among working adults. This study was designed to increase workplace influenza vaccination rates by offering both a choice of intranasal (LAIV) and injectable (TIV) influenza vaccines to eligible employees, and an incentive for being vaccinated, and by increasing awareness of the vaccine clinic. This study used a stratified randomized cluster trial. A total of 12,222 employees in 53 U.S. companies with previous influenza vaccine clinics were examined. Control sites advertised and offered vaccine clinics as previously done. Choice sites offered LAIV or TIV and maintained their previous advertising level but promoted the choice of vaccines. Choice Plus sites increased advertising and promoted and offered a choice of vaccines and a nominal incentive. These included vaccination rates among eligible employees. Hierarchic linear modeling (HLM) was used to determine factors associated with vaccination. The overall vaccination rate increased from 39% in 2007-2008 to 46% in 2008-2009 (p<0.001). The difference in vaccination rates for LAIV was 6.5% for Choice versus Control and 9.9% for Choice Plus versus Control (both p<0.001). Rates of TIV increased by 15.9 percentage points in the Choice Plus arm versus Control for workers aged > or =50 years (p=0.024). Rates of TIV did not change in workers aged 18-49 years in either intervention arm or in workers aged > or =50 years in the Choice arm. In HLM analyses, factors significantly associated with increased vaccination were older age, female gender, previous company vaccination rate, and the Choice Plus intervention. An incentive for vaccination, an intensified advertising campaign, and offering a choice of influenza vaccines improved vaccination rates in the workplace. Copyright (c) 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Mindfulness Meditation Training and Executive Control Network Resting State Functional Connectivity: A Randomized Controlled Trial.

PubMed

Taren, Adrienne A; Gianaros, Peter J; Greco, Carol M; Lindsay, Emily K; Fairgrieve, April; Brown, Kirk Warren; Rosen, Rhonda K; Ferris, Jennifer L; Julson, Erica; Marsland, Anna L; Creswell, J David

Mindfulness meditation training has been previously shown to enhance behavioral measures of executive control (e.g., attention, working memory, cognitive control), but the neural mechanisms underlying these improvements are largely unknown. Here, we test whether mindfulness training interventions foster executive control by strengthening functional connections between dorsolateral prefrontal cortex (dlPFC)-a hub of the executive control network-and frontoparietal regions that coordinate executive function. Thirty-five adults with elevated levels of psychological distress participated in a 3-day randomized controlled trial of intensive mindfulness meditation or relaxation training. Participants completed a resting state functional magnetic resonance imaging scan before and after the intervention. We tested whether mindfulness meditation training increased resting state functional connectivity (rsFC) between dlPFC and frontoparietal control network regions. Left dlPFC showed increased connectivity to the right inferior frontal gyrus (T = 3.74), right middle frontal gyrus (MFG) (T = 3.98), right supplementary eye field (T = 4.29), right parietal cortex (T = 4.44), and left middle temporal gyrus (T = 3.97, all p < .05) after mindfulness training relative to the relaxation control. Right dlPFC showed increased connectivity to right MFG (T = 4.97, p < .05). We report that mindfulness training increases rsFC between dlPFC and dorsal network (superior parietal lobule, supplementary eye field, MFG) and ventral network (right IFG, middle temporal/angular gyrus) regions. These findings extend previous work showing increased functional connectivity among brain regions associated with executive function during active meditation by identifying specific neural circuits in which rsFC is enhanced by a mindfulness intervention in individuals with high levels of psychological distress. Clinicaltrials.gov,NCT01628809.

Effect of endometrial biopsy on intrauterine insemination outcome in controlled ovarian stimulation cycle

PubMed Central

Wadhwa, Leena; Pritam, Amrita; Gupta, Taru; Gupta, Sangeeta; Arora, Sarika; Chandoke, Rajkumar

2015-01-01

OBJECTIVE: The objective was to evaluate the effect of endometrial biopsy (EB) on intrauterine insemination (IUI) outcome in controlled ovarian stimulation (COS) cycle. DESIGN: Prospective randomized control study. SETTING: Tertiary care center. MATERIALS AND METHODS: A total of 251 subjects were enrolled in the study. Subjects undergoing COS with IUI were randomly allocated into three groups. Group A: EB was taken between D19 and 24 of the spontaneous menstrual cycles that precedes the fertility treatment and IUI, which was done in next cycle (n = 86). Group B: EB was taken before D6 of the menstrual cycle, and fertility treatment and IUI was done in the same cycle (n = 90). Group C: (control group) no EB in previous 3 cycle (n = 75). MAIN OUTCOME MEASURE: Clinical pregnancy rate (CPR). RESULTS: Clinical pregnancy rate was 19.77%, 31.11%, and 9.3% for Group A, Group B, and Group C, respectively. The results show a highly significant value for the paired t-test of intervention Group B and control Group C of the cases (P = 0.000957). CPR was maximum after first cycle of ovulation induction and IUI following EB scratch in both Groups A and in Group B (P < 0.001). CONCLUSIONS: Endometrial biopsy done in early follicular phase in the same cycle of stimulation with IUI gives better CPR as compared with EB done in the luteal phase of the previous cycle. PMID:26538858

Role of supplemental calcium in the recurrence of colorectal adenomas: a metaanalysis of randomized controlled trials.

PubMed

Shaukat, Aasma; Scouras, Nicole; Schünemann, Holger J

2005-02-01

Colorectal adenomas are neoplastic growths that are important targets for chemoprevention. Dietary calcium is thought to play an important role in chemoprevention. However, the role of calcium supplementation for preventing recurrence of adenomas is controversial. We performed a systematic review and meta-analysis to study the role of calcium supplementation in preventing recurrence of adenomas. We searched electronic bibliographic databases (Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, CINAHL, EMBASE, and MEDLINE) and contacted authors to identify potentially eligible studies. We identified three trials including 1,485 subjects with previously removed adenomas who were randomized to calcium versus placebo supplementation. The study endpoint was recurrence of adenomas at the end of 3-4 yr in 1,279 patients who completed the trials. We found that the recurrence of adenomas was significantly lower in subjects randomized to calcium supplementation (RR: 0.80, CI: 0.68, 0.93; p-value = 0.004). This systematic review and meta-analysis suggest that calcium supplementation prevents recurrent colorectal adenomas.

Kindness in the blood: A randomized controlled trial of the gene regulatory impact of prosocial behavior.

PubMed

Nelson-Coffey, S Katherine; Fritz, Megan M; Lyubomirsky, Sonja; Cole, Steve W

2017-07-01

Prosocial behavior is linked to longevity, but few studies have experimentally manipulated prosocial behavior to identify the causal mechanisms underlying this association. One possible mediating pathway involves changes in gene expression that may subsequently influence disease development or resistance. In the current study, we examined changes in a leukocyte gene expression profile known as the Conserved Transcriptional Response to Adversity (CTRA) in 159 adults who were randomly assigned for 4 weeks to engage in prosocial behavior directed towards specific others, prosocial behavior directed towards the world in general, self-focused kindness, or a neutral control task. Those randomized to prosocial behavior towards specific others demonstrated improvements (i.e., reductions) in leukocyte expression of CTRA indicator genes. No significant changes in CTRA gene expression were observed in the other 3 conditions. These findings suggest that prosocial behavior can causally impact leukocyte gene expression profiles in ways that might potentially help explain the previously observed health advantages associated with social ties. Copyright © 2017 Elsevier Ltd. All rights reserved.

Response-Order Effects in Survey Methods: A Randomized Controlled Crossover Study in the Context of Sport Injury Prevention.

PubMed

Chan, Derwin K; Ivarsson, Andreas; Stenling, Andreas; Yang, Sophie X; Chatzisarantis, Nikos L; Hagger, Martin S

2015-12-01

Consistency tendency is characterized by the propensity for participants responding to subsequent items in a survey consistent with their responses to previous items. This method effect might contaminate the results of sport psychology surveys using cross-sectional design. We present a randomized controlled crossover study examining the effect of consistency tendency on the motivational pathway (i.e., autonomy support → autonomous motivation → intention) of self-determination theory in the context of sport injury prevention. Athletes from Sweden (N = 341) responded to the survey printed in either low interitem distance (IID; consistency tendency likely) or high IID (consistency tendency suppressed) on two separate occasions, with a one-week interim period. Participants were randomly allocated into two groups, and they received the survey of different IID at each occasion. Bayesian structural equation modeling showed that low IID condition had stronger parameter estimates than high IID condition, but the differences were not statistically significant.

Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke: A Randomized Controlled Trial.

PubMed

Bath, Philip M; Scutt, Polly; Love, Jo; Clavé, Pere; Cohen, David; Dziewas, Rainer; Iversen, Helle K; Ledl, Christian; Ragab, Suzanne; Soda, Hassan; Warusevitane, Anushka; Woisard, Virginie; Hamdy, Shaheen

2016-06-01

Dysphagia is common after stroke, associated with increased death and dependency, and treatment options are limited. Pharyngeal electric stimulation (PES) is a novel treatment for poststroke dysphagia that has shown promise in 3 pilot randomized controlled trials. We randomly assigned 162 patients with a recent ischemic or hemorrhagic stroke and dysphagia, defined as a penetration aspiration score (PAS) of ≥3 on video fluoroscopy, to PES or sham treatment given on 3 consecutive days. The primary outcome was swallowing safety, assessed using the PAS, at 2 weeks. Secondary outcomes included dysphagia severity, function, quality of life, and serious adverse events at 6 and 12 weeks. In randomized patients, the mean age was 74 years, male 58%, ischemic stroke 89%, and PAS 4.8. The mean treatment current was 14.8 (7.9) mA and duration 9.9 (1.2) minutes per session. On the basis of previous data, 45 patients (58.4%) randomized to PES seemed to receive suboptimal stimulation. The PAS at 2 weeks, adjusted for baseline, did not differ between the randomized groups: PES 3.7 (2.0) versus sham 3.6 (1.9), P=0.60. Similarly, the secondary outcomes did not differ, including clinical swallowing and functional outcome. No serious adverse device-related events occurred. In patients with subacute stroke and dysphagia, PES was safe but did not improve dysphagia. Undertreatment of patients receiving PES may have contributed to the neutral result. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25681641. © 2016 The Authors.

Insights, attitudes and perceptions about asthma and its treatment: findings from a multinational survey of patients from 8 Asia-Pacific countries and Hong Kong.

PubMed

Thompson, Philip J; Salvi, Sundeep; Lin, Jiangtao; Cho, Young Joo; Eng, Philip; Abdul Manap, Roslina; Boonsawat, Watchara; Hsu, Jeng-Yuan; Faruqi, Rab A; Moreno-Cantu, Jorge J; Fish, James E; Ho, James Chung-Man

2013-08-01

The Asthma Insight and Management (AIM) survey was conducted in North America, Europe, the Asia-Pacific region and Latin America to characterize patients' insights, attitudes and perceptions about their asthma and its treatment. We report findings from the Asia-Pacific survey. Asthma patients (≥12 years) from Australia, China, Hong Kong, India, Malaysia, Singapore, South Korea, Taiwan and Thailand were surveyed. Patients answered 53 questions exploring general health, diagnosis/history, symptoms, exacerbations, patient burden, disease management, medications/treatments and patient's attitudes. The Global Initiative for Asthma guidelines were used to assess asthma control. The survey was conducted by random digit telephone dialling (Australia, China and Hong Kong) or by random face-to-face interviews (India, Malaysia, Singapore, South Korea, Taiwan and Thailand). There were 80 761 households screened. Data from 3630 patients were collected. Wide disparity existed between objective measures of control and patient perception. Reported exacerbations during the previous year ranged from 19% (Hong Kong) to 67% (India). Reported unscheduled urgent/emergency visits to a doctor's office/hospital/clinic in the previous year ranged from 15% (Hong Kong) to 46% (Taiwan). Patients who reported having controlled asthma in the previous month ranged from 27% (South Korea) to 84% (Taiwan). Substantial functional and emotional limitations due to asthma were identified by 13% (South Korea) to 78% (India) of patients. Asthma has a profound impact on patients' well-being despite the availability of effective treatments and evidence-based management guidelines. Substantial differences across the surveyed countries exist, suggesting unmet, country-specific cultural and educational needs. A large proportion of asthma patients overestimate their level of control. © 2013 The Authors. Respirology © 2013 Asian Pacific Society of Respirology.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

PubMed

Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

A Randomized Controlled Trial to Examine the Effects of the Tackling Teenage Psychosexual Training Program for Adolescents with Autism Spectrum Disorder

ERIC Educational Resources Information Center

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

2017-01-01

Background: Previous research underscores the importance of psychosexual guidance for adolescents with autism spectrum disorder (ASD). Such guidance is provided in the Tackling Teenage Training (TTT) program, in which adolescents with ASD receive psycho-education and practice communicative skills regarding topics related to puberty, sexuality, and…

School-Based Mentoring Programs: Using Volunteers to Improve the Academic Outcomes of Underserved Students

ERIC Educational Resources Information Center

Bayer, Amanda; Grossman, Jean Baldwin; DuBois, David L.

2013-01-01

Previous research suggests that school-based mentoring programs like those offered by Big Brothers Big Sisters of America (BBBSA) yield small but statistically significant improvements in the academic performance of mentored students and in their beliefs in their own scholastic efficacy. The present study uses data from a randomized control trial…

Acceptance and Commitment Therapy versus Cognitive Therapy for the Treatment of Comorbid Eating Pathology

ERIC Educational Resources Information Center

Juarascio, Adrienne S.; Forman, Evan M.; Herbert, James D.

2010-01-01

Previous research has indicated that although eating pathology is prevalent in college populations, both CBT and non-CBT-based therapies achieve only limited effectiveness. The current study examined several questions related to the treatment of eating pathology within the context of a larger randomized controlled trial that compared standard CBT…

Utilizing Peer Moderating in Online Discussions: Addressing the Controversy between Teacher Moderation and Nonmoderation

ERIC Educational Resources Information Center

Seo, Kay Kyeongju

2007-01-01

This study focused on the effects of peer moderation on meaningful interactions in online discussions. A meaningful interaction was defined as a message relating to a discussion topic, responding to a previous message, and adding substance to the discussion. A randomized-subject, posttest-only control group design was used to test the first…

Understanding Relations among Early Family Environment, Cortisol Response, and Child Aggression via a Prevention Experiment

ERIC Educational Resources Information Center

O'Neal, Colleen R.; Brotman, Laurie Miller; Huang, Keng-Yen; Gouley, Kathleen Kiely; Kamboukos, Dimitra; Calzada, Esther J.; Pine, Daniel S.

2010-01-01

This study examined relations among family environment, cortisol response, and behavior in the context of a randomized controlled trial with 92 children (M = 48 months) at risk for antisocial behavior. Previously, researchers reported an intervention effect on cortisol response in anticipation of a social challenge. The current study examined…

Effectiveness of Semantic Therapy for Word-Finding Difficulties in Pupils with Persistent Language Impairments: A Randomized Control Trial

ERIC Educational Resources Information Center

Ebbels, Susan H.; Nicoll, Hilary; Clark, Becky; Eachus, Beth; Gallagher, Aoife L.; Horniman, Karen; Jennings, Mary; McEvoy, Kate; Nimmo, Liz; Turner, Gail

2012-01-01

Background: Word-finding difficulties (WFDs) in children have been hypothesized to be caused at least partly by poor semantic knowledge. Therefore, improving semantic knowledge should decrease word-finding errors. Previous studies of semantic therapy for WFDs are inconclusive. Aims: To investigate the effectiveness of semantic therapy for…

A Randomized Controlled Trial Validating the Impact of the LASER Model of Science Education on Student Achievement and Teacher Instruction

ERIC Educational Resources Information Center

Kaldon, Carolyn R.; Zoblotsky, Todd A.

2014-01-01

Previous research has linked inquiry-based science instruction (i.e., science instruction that engages students in doing science rather than just learning about science) with greater gains in student learning than text-book based methods (Vanosdall, Klentschy, Hedges & Weisbaum, 2007; Banilower, 2007; Ferguson 2009; Bredderman, 1983;…

Implementing Large-Scale Instructional Technology in Kenya: Changing Instructional Practice and Developing Accountability in a National Education System

ERIC Educational Resources Information Center

Piper, Benjamin; Oyanga, Arbogast; Mejia, Jessica; Pouezevara, Sarah

2017-01-01

Previous large-scale education technology interventions have shown only modest impacts on student achievement. Building on results from an earlier randomized controlled trial of three different applications of information and communication technologies (ICTs) on primary education in Kenya, the Tusome Early Grade Reading Activity developed the…

Multi-Exciter Vibroacoustic Simulation of Hypersonic Flight Vibration

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

GREGORY,DANNY LYNN; CAP,JEROME S.; TOGAMI,THOMAS C.

1999-11-11

Many aerospace structures must survive severe high frequency, hypersonic, random vibration during their flights. The random vibrations are generated by the turbulent boundary layer developed along the exterior of the structures during flight. These environments have not been simulated very well in the past using a fixed-based, single exciter input with an upper frequency range of 2 kHz. This study investigates the possibility of using acoustic ardor independently controlled multiple exciters to more accurately simulate hypersonic flight vibration. The test configuration, equipment, and methodology are described. Comparisons with actual flight measurements and previous single exciter simulations are also presented.

Random Signal Fluctuations Can Reduce Random Fluctuations in Regulated Components of Chemical Regulatory Networks

NASA Astrophysics Data System (ADS)

Paulsson, Johan; Ehrenberg, Måns

2000-06-01

Many intracellular components are present in low copy numbers per cell and subject to feedback control. We use chemical master equations to analyze a negative feedback system where species X and S regulate each other's synthesis with standard intracellular kinetics. For a given number of X-molecules, S-variation can be significant. We show that this signal noise does not necessarily increase X-variation as previously thought but, surprisingly, can be necessary to reduce it below a Poissonian limit. The principle resembles Stochastic Resonance in that signal noise improves signal detection.

Simulation using computer-piloted point excitations of vibrations induced on a structure by an acoustic environment

NASA Astrophysics Data System (ADS)

Monteil, P.

1981-11-01

Computation of the overall levels and spectral densities of the responses measured on a launcher skin, the fairing for instance, merged into a random acoustic environment during take off, was studied. The analysis of transmission of these vibrations to the payload required the simulation of these responses by a shaker control system, using a small number of distributed shakers. Results show that this closed loop computerized digital system allows the acquisition of auto and cross spectral densities equal to those of the responses previously computed. However, wider application is sought, e.g., road and runway profiles. The problems of multiple input-output system identification, multiple true random signal generation, and real time programming are evoked. The system should allow for the control of four shakers.

Criticality of Adaptive Control Dynamics

NASA Astrophysics Data System (ADS)

Patzelt, Felix; Pawelzik, Klaus

2011-12-01

We show, that stabilization of a dynamical system can annihilate observable information about its structure. This mechanism induces critical points as attractors in locally adaptive control. It also reveals, that previously reported criticality in simple controllers is caused by adaptation and not by other controller details. We apply these results to a real-system example: human balancing behavior. A model of predictive adaptive closed-loop control subject to some realistic constraints is introduced and shown to reproduce experimental observations in unprecedented detail. Our results suggests, that observed error distributions in between the Lévy and Gaussian regimes may reflect a nearly optimal compromise between the elimination of random local trends and rare large errors.

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial

PubMed Central

Chaillous, Lucy; Franc, Sylvia; Benhamou, Pierre-Yves; Schaepelynck, Pauline; Hanaire, Hélène; Catargi, Bogdan; Farret, Anne; Fontaine, Pierre; Guerci, Bruno; Reznik, Yves; Penfornis, Alfred; Borot, Sophie; Serusclat, Pierre; Kherbachi, Yacine; D'Orsay, Geneviève; Detournay, Bruno; Simon, Pierre; Charpentier, Guillaume

2018-01-01

Background Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Objective Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. Methods TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. Results The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. Conclusions The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. Trial Registration ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd) PMID:29674306

Randomized Controlled Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder.

PubMed

Gabriels, Robin L; Pan, Zhaoxing; Dechant, Briar; Agnew, John A; Brim, Natalie; Mesibov, Gary

2015-07-01

This study expands previous equine-assisted intervention research by evaluating the effectiveness of therapeutic horseback riding (THR) on self-regulation, socialization, communication, adaptive, and motor behaviors in children with autism spectrum disorder (ASD). Participants with ASD (aged 6-16 years; N = 127) were stratified by nonverbal IQ standard scores (≤85 or >85) and randomized to 1 of 2 groups for 10 weeks: THR intervention or a barn activity (BA) control group without horses that used similar methods. The fidelity of the THR intervention was monitored. Participants were evaluated within 1 month pre- and postintervention by raters blinded to intervention conditions and unblinded caregiver questionnaires. During the intervention, caregivers rated participants' behaviors weekly. Intent-to-treat analysis conducted on the 116 participants who completed a baseline assessment (THR n = 58; BA control n = 58) revealed significant improvements in the THR group compared to the control on measures of irritability (primary outcome) (p = .02; effect size [ES] = 0.50) and hyperactivity (p = .01; ES = 0.53), beginning by week 5 of the intervention. Significant improvements in the THR group were also observed on a measure of social cognition (p = .05; ES = 0.41) and social communication (p = .003; ES = 0.63), along with the total number of words (p = .01; ES = 0.54) and new words (p = .01; ES = 0.54) spoken during a standardized language sample. Sensitivity analyses adjusting for age, IQ, and per protocol analyses produced consistent results. This is the first large-scale, randomized, controlled trial demonstrating efficacy of THR for the ASD population, and findings are consistent with previous equine-assisted intervention studies. Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder; http://clinicaltrials.gov; NCT02301195. Published by Elsevier Inc.

Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial.

PubMed

Saper, Robert B; Lemaster, Chelsey M; Elwy, A Rani; Paris, Ruth; Herman, Patricia M; Plumb, Dorothy N; Sherman, Karen J; Groessl, Erik J; Lynch, Susan; Wang, Shihwe; Weinberg, Janice

2016-04-29

Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations. This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records. This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities. ClinicalTrials.gov: NCT02224183.

Fabrication of scalable tissue engineering scaffolds with dual-pore microarchitecture by combining 3D printing and particle leaching.

PubMed

Mohanty, Soumyaranjan; Sanger, Kuldeep; Heiskanen, Arto; Trifol, Jon; Szabo, Peter; Dufva, Marin; Emnéus, Jenny; Wolff, Anders

2016-04-01

Limitations in controlling scaffold architecture using traditional fabrication techniques are a problem when constructing engineered tissues/organs. Recently, integration of two pore architectures to generate dual-pore scaffolds with tailored physical properties has attracted wide attention in tissue engineering community. Such scaffolds features primary structured pores which can efficiently enhance nutrient/oxygen supply to the surrounding, in combination with secondary random pores, which give high surface area for cell adhesion and proliferation. Here, we present a new technique to fabricate dual-pore scaffolds for various tissue engineering applications where 3D printing of poly(vinyl alcohol) (PVA) mould is combined with salt leaching process. In this technique the sacrificial PVA mould, determining the structured pore architecture, was filled with salt crystals to define the random pore regions of the scaffold. After crosslinking the casted polymer the combined PVA-salt mould was dissolved in water. The technique has advantages over previously reported ones, such as automated assembly of the sacrificial mould, and precise control over pore architecture/dimensions by 3D printing parameters. In this study, polydimethylsiloxane and biodegradable poly(ϵ-caprolactone) were used for fabrication. However, we show that this technique is also suitable for other biocompatible/biodegradable polymers. Various physical and mechanical properties of the dual-pore scaffolds were compared with control scaffolds with either only structured or only random pores, fabricated using previously reported methods. The fabricated dual-pore scaffolds supported high cell density, due to the random pores, in combination with uniform cell distribution throughout the scaffold, and higher cell proliferation and viability due to efficient nutrient/oxygen transport through the structured pores. In conclusion, the described fabrication technique is rapid, inexpensive, scalable, and compatible with different polymers, making it suitable for engineering various large scale organs/tissues. Copyright © 2015. Published by Elsevier B.V.

Low back pain in female elite football and handball players compared with an active control group.

PubMed

Tunås, Paula; Nilstad, Agnethe; Myklebust, Grethe

2015-09-01

The purpose of this cross-sectional study was to compare the prevalence of low back pain (LBP) among female elite football and handball players to a matched non-professional active control group. The participants were requested to answer a questionnaire based on standardized Nordic questionnaires for musculoskeletal symptoms to assess the prevalence of LBP. Included participants were elite female football (n = 277) and handball players (n = 190), and a randomly selected control group from the Norwegian population (n = 167). Fifty-seven percentage of the football players, 59 % of the handball players and 60 % of the control group had experienced LBP the previous year. There were no significant group differences in the prevalence of LBP ever (p = 0.62), the previous year (p = 0.85) or the previous 7 days (p = 0.63). For both sports, there was a significant increase in prevalence of LBP from the resting period to the competitive periods of the season (p ≤ 0.001). Seventy percent of the goalkeepers in both football and handball had experienced LBP the previous year. There were no difference in LBP among female elite football and handball players compared with the control group. However, female elite athletes in football and handball reported a high prevalence of LBP compared to previous studies. The variations in LBP and playing positions indicate that specific field positions, in football and handball, is a risk factor for developing LBP.

Effects of barbell deadlift training on submaximal motor unit firing rates for the vastus lateralis and rectus femoris.

PubMed

Stock, Matt S; Thompson, Brennan J

2014-01-01

Previous investigations that have studied motor unit firing rates following strength training have been limited to small muscles, isometric training, or interventions involving exercise machines. We examined the effects of ten weeks of supervised barbell deadlift training on motor unit firing rates for the vastus lateralis and rectus femoris during a 50% maximum voluntary contraction (MVC) assessment. Twenty-four previously untrained men (mean age  = 24 years) were randomly assigned to training (n = 15) or control (n = 9) groups. Before and following the intervention, the subjects performed isometric testing of the right knee extensors while bipolar surface electromyographic signals were detected from the two muscles. The signals were decomposed into their constituent motor unit action potential trains, and motor units that demonstrated accuracy levels less than 92.0% were not considered for analysis. One thousand eight hundred ninety-two and 2,013 motor units were examined for the vastus lateralis and rectus femoris, respectively. Regression analyses were used to determine the linear slope coefficients (pulses per second [pps]/% MVC) and y-intercepts (pps) of the mean firing rate and firing rate at recruitment versus recruitment threshold relationships. Deadlift training significantly improved knee extensor MVC force (Cohen's d = .70), but did not influence force steadiness. Training had no influence on the slopes and y-intercepts for the mean firing rate and firing rate at recruitment versus recruitment threshold relationships. In agreement with previous cross-sectional comparisons and randomized control trials, our findings do not support the notion that strength training affects the submaximal control of motor units.

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

PubMed

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

2008-04-01

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

Expressive writing intervention and self-reported physical health out-comes - Results from a nationwide randomized controlled trial with breast cancer patients.

PubMed

Jensen-Johansen, Mikael B; O'Toole, Mia S; Christensen, Søren; Valdimarsdottir, Heiddis; Zakowski, Sandra; Bovbjerg, Dana H; Jensen, Anders B; Zachariae, Robert

2018-01-01

The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related to emotion regulation as possible moderators of the effect. Women who had recently completed treatment for primary breast cancer (n = 507) were randomly assigned to three 20 min. home-based writing exercises, one week apart, focusing on emotional disclosure (EWI) of a distressing experience (their cancer or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about their own cancer, but not women writing about other topics, showed a larger decrease than controls. The results from this large randomized trial are concordant with previous findings showing that EWI is unlikely to be a generally applicable intervention to improve health-related outcomes in cancer patients and cancer survivors. However, written disclosure might have a beneficial impact for individuals who write about their own cancer, as well as for those low in alexithymia.

Expressive writing intervention and self-reported physical health out-comes – Results from a nationwide randomized controlled trial with breast cancer patients

PubMed Central

Jensen-Johansen, Mikael B.; Christensen, Søren; Valdimarsdottir, Heiddis; Zakowski, Sandra; Bovbjerg, Dana H.; Jensen, Anders B.; Zachariae, Robert

2018-01-01

The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related to emotion regulation as possible moderators of the effect. Women who had recently completed treatment for primary breast cancer (n = 507) were randomly assigned to three 20 min. home-based writing exercises, one week apart, focusing on emotional disclosure (EWI) of a distressing experience (their cancer or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints, and writing topic. Results revealed no group by time interaction effects for any outcomes. Moderation analyses showed that 1) low alexithymic women in the EWI group showed larger decreases in GP telephone calls over time than both high alexithymic women and controls and 2) women in the EWI group writing about their own cancer, but not women writing about other topics, showed a larger decrease than controls. The results from this large randomized trial are concordant with previous findings showing that EWI is unlikely to be a generally applicable intervention to improve health-related outcomes in cancer patients and cancer survivors. However, written disclosure might have a beneficial impact for individuals who write about their own cancer, as well as for those low in alexithymia. PMID:29474441

Effects of Massage on Blood Pressure in Patients With Hypertension and Prehypertension: A Meta-analysis of Randomized Controlled Trials.

PubMed

Liao, I-Chen; Chen, Shiah-Lian; Wang, Mei-Yeh; Tsai, Pei-Shan

2016-01-01

Massage may help reduce blood pressure; previous studies on the effect of massage on blood pressure have presented conflicting findings. In addition, no systematic review is available. The aim of this study was to evaluate the evidence concerning the effect of massage on blood pressure in patients with hypertension or prehypertension. A search was performed on electronic database records up to October 31, 2013, based on the following medical subject headings or keywords: hypertension, massage, chiropractic, manipulation, and blood pressure. The methodological quality of randomized controlled trials was assessed based on the Cochrane collaboration tool. A meta-analysis was performed to evaluate the effect of massage on hypertension. The study selection, data extraction, and validation were performed independently by 2 reviewers. Nine randomized controlled trials met our inclusion criteria. The results of this study show that massage contributes to significantly enhanced reduction in both systolic blood pressure (SBP) (mean difference, -7.39 mm Hg) and diastolic blood pressure (DBP) (mean difference, -5.04 mm Hg) as compared with control treatments in patients with hypertension and prehypertension. The effect size (Hedges g) for SBP and DBP was -0.728 (95% confidence interval, -1.182 to -0.274; P = .002) and -0.334 (95% confidence interval, -0.560 to -0.107; P = .004), respectively. This systematic review found a medium effect of massage on SBP and a small effect on DBP in patients with hypertension or prehypertension. High-quality randomized controlled trials are urgently required to confirm these results, although the findings of this study can be used to guide future research.

Closed loop statistical performance analysis of N-K knock controllers

NASA Astrophysics Data System (ADS)

Peyton Jones, James C.; Shayestehmanesh, Saeed; Frey, Jesse

2017-09-01

The closed loop performance of engine knock controllers cannot be rigorously assessed from single experiments or simulations because knock behaves as a random process and therefore the response belongs to a random distribution also. In this work a new method is proposed for computing the distributions and expected values of the closed loop response, both in steady state and in response to disturbances. The method takes as its input the control law, and the knock propensity characteristic of the engine which is mapped from open loop steady state tests. The method is applicable to the 'n-k' class of knock controllers in which the control action is a function only of the number of cycles n since the last control move, and the number k of knock events that have occurred in this time. A Cumulative Summation (CumSum) based controller falls within this category, and the method is used to investigate the performance of the controller in a deeper and more rigorous way than has previously been possible. The results are validated using onerous Monte Carlo simulations, which confirm both the validity of the method and its high computational efficiency.

Impact of an Intervention Designed to Reduce Sexual Health Risk Behaviors of African American Adolescents: Results of a Randomized Controlled Trial

PubMed Central

Jenner, Lynne W.; Walsh, Sarah; Demby, Hilary; Gregory, Alethia; Davis, Erin

2016-01-01

Objectives. To replicate an evidence-based HIV risk reduction program and assess its impact on 2 behavioral outcomes—inconsistency of condom use and frequency of sex—6 months after the program. Methods. The study was an individual-level randomized controlled trial in which we randomly assigned 850 youths (aged 14–18 years) to 1 of 2 conditions. The treatment (Becoming a Responsible Teen) is a group-level sociocognitive and skills training sexual education course; the control is a general health intervention that includes the same initial informational component as the treatment. Participants were recruited over 3 summers (2012–2014) from a summer employment program in New Orleans, Louisiana, that serves primarily African American adolescents. Results. Six months after program exposure, we found no statistically significant difference between treatment and control group members’ self-reported inconsistency of condom use or frequency of sex (P > .05). Conclusions. Although previous evidence has indicated that this particular program can be effective, this study’s findings indicate that it was not effective in this setting with this specific population. Results should provide an incentive to learn why the intervention works in some cases and what conditions are necessary for causal impacts. PMID:27689499

Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial

PubMed Central

2013-01-01

Background The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvements in several clinical outcomes. The aim of the present study is to investigate the effect of OMT on LOS in premature infants. Methods A randomized controlled trial was conducted on preterm newborns admitted to a single NICU between 2008-2009. N=110 subjects free of medical complications and with gestational age >28 and < 38 weeks were enrolled and randomized in two groups: study group (N=55) and control group (N=55). All subjects received routine pediatric care and OMT was performed to the study group for the entire period of hospitalization. Endpoints of the study included differences in LOS and daily weight gain. Results Results showed a significant association between OMT and LOS reduction (mean difference between treated and control group: -5.906; 95% C.I. -7.944, -3.869; p<0.001). OMT was not associated to any change in daily weight gain. Conclusions The present study suggests that OMT may have an important role in the management of preterm infants hospitalization. Trial registration ClinicalTrials.gov, NCT01544257. PMID:23622070

Randomized controlled GH trial: effects on anthropometry, body composition and body proportions in a large group of children with Prader-Willi syndrome.

PubMed

Festen, Dederieke A M; de Lind van Wijngaarden, Roderick; van Eekelen, Marielle; Otten, Barto J; Wit, Jan M; Duivenvoorden, Hugo J; Hokken-Koelega, Anita C S

2008-09-01

Prader-Willi syndrome (PWS) children have impaired growth, and abnormal body composition. Previous 1-year controlled studies showed improvement of height and body composition during GH-treatment. To evaluate growth, body composition and body proportions during GH-treatment in a large group of PWS children. We performed a randomized controlled GH trial in 91 prepubertal PWS children (42 infants, 49 children, aged 3-14 years). After stratification for age, infants were randomized to GH-treatment (GH-group; 1 mg/m(2)/day; n = 20), or no treatment (control group; n = 22) for 1 year. In the second year all infants were treated with GH. After stratification for BMI, children > 3 years of age were randomized to GH-treatment (GH-group; 1 mg/m(2)/day; n = 27) or no treatment (control group; n = 22) for 2 years. Anthropometric parameters were assessed once in every 3 months. Body composition was measured by Dual Energy X-ray Absorptiometry. Median (interquartile range, iqr) height SDS increased during 2 years of GH in infants from -2.3 (-2.8 to -0.7) to -0.4 (-1.1-0.0) and in prepubertal children from -2.0 (-3.1 to -1.7) to -0.6 (-1.1 to -0.1). In non-GH-treated children height SDS did not increase. Head circumference completely normalized during 1 and 2 years of GH in infants and children, respectively. Body fat percentage and body proportions improved in GH-treated children, but did not completely normalize. Lean body mass SDS improved compared to the control group. Serum IGF-I increased to levels above the normal range in most GH-treated children. Our randomized study shows that GH-treatment in PWS children significantly improves height, BMI, head circumference, body composition and body proportions. PWS children are highly sensitive to GH, suggesting that monitoring of serum IGF-I is indicated.

A randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux disease (GERD): 3-year outcomes.

PubMed

Anvari, Mehran; Allen, Christopher; Marshall, John; Armstrong, David; Goeree, Ron; Ungar, Wendy; Goldsmith, Charles

2011-08-01

A randomized controlled trial (RCT) investigated patients with gastroesophageal reflux disease (GERD) who were stable and symptomatically controlled with long-term medical therapy to compare ongoing optimized medical therapy with laparoscopic Nissen fundoplication (LNF). Of the 180 patients eligible for randomization, 104 gave informed consent, and 3 withdrew from the study immediately after randomization. The patients randomized to medical therapy received optimized treatment with proton pump inhibitors (PPIs) using a standardized management protocol based on best evidence and published guidelines. The surgical patients underwent LNF by one of four surgeons using a previously published technique. The patients underwent symptom evaluation using the GERD symptom scale (GERSS) and the global visual analog scale (VAS) for overall symptom control. They had 24-h esophageal pH monitoring at baseline and after 3 years. The medical patients were evaluated receiving PPI, and the surgical patients were evaluated not receiving PPI. For the 3-year follow-up assessment, 93 patients were available. At 3 years, surgery was associated with more heartburn-free days, showing a mean difference of -1.35 days per week (p = 0.0077) and a lower VAS score (p = 0.0093) than medical management. Surgical patients reported improved quality of life on the general health subscore of the Medical Outcomes Survey Short Form 36 (SF-36) at 3 years, with a mean difference of -12.19 (p = 0.0124). The groups did not differ significantly in terms of GERSS or acid exposure on 24-h esophageal pH monitoring at 3 years. There were six treatment failures (11.8%) in the surgical group and eight treatment failures (16%) in the medical group by 3 years. For patients whose GERD symptoms are stable and controlled with PPI, continuing medical therapy and laparoscopic antireflux surgery are equally effective, although surgery may result in better symptom control and quality of life.

Methodological Challenges of Multiple-Component Intervention: Lessons Learned from a Randomized Controlled Trial of Functional Recovery After Hip Fracture

PubMed Central

Peterson, Margaret G.E.; Cornell, Charles N.; MacKenzie, C. Ronald; Robbins, Laura; Horton, Roberta; Ganz, Sandy B.; Ruchlin, Hirsch S.; Russo, Pamela Williams; Paget, Stephen A.; Charlson, Mary E.

2006-01-01

We conducted a randomized controlled trial to assess the efficacy and safety of a multiple-component intervention designed to improve functional recovery after hip fracture. One hundred seventy-six patients who underwent surgery for a primary unilateral hip fracture were assigned randomly to receive usual care (control arm, n = 86) or a brief motivational videotape, supportive peer counseling, and high-intensity muscle-strength training (intervention arm, n = 90). Between-group differences on the physical functioning, role-physical, and social functioning domains of the SF-36 were assessed postoperatively at 6 months. At the end of the trial, 32 intervention and 27 control patients (34%) completed the 6-month outcome assessment. Although patient compliance with all three components of the intervention was uneven, over 90% of intervention patients were exposed to the motivational videotape. Intervention patients experienced a significant (P = 0.03) improvement in the role-physical domain (mean change, −11 ± 33) compared to control patients (mean change, −37 ± 41). Change in general health (P = 0.2) and mental health (P = 0.1) domain scores was also directionally consistent with the study hypothesis. Although our findings are consistent with previous reports of comprehensive rehabilitation efforts for hip fracture patients, the trial was undermined by high attrition and the possibility of self-selection bias at 6-month follow-up. We discuss the methodological challenges and lessons learned in conducting a randomized controlled trial that sought to implement and assess the impact of a complex intervention in a population that proved difficult to follow up once they had returned to the community. PMID:18751772

Optimization of controllability and robustness of complex networks by edge directionality

NASA Astrophysics Data System (ADS)

Liang, Man; Jin, Suoqin; Wang, Dingjie; Zou, Xiufen

2016-09-01

Recently, controllability of complex networks has attracted enormous attention in various fields of science and engineering. How to optimize structural controllability has also become a significant issue. Previous studies have shown that an appropriate directional assignment can improve structural controllability; however, the evolution of the structural controllability of complex networks under attacks and cascading has always been ignored. To address this problem, this study proposes a new edge orientation method (NEOM) based on residual degree that changes the link direction while conserving topology and directionality. By comparing the results with those of previous methods in two random graph models and several realistic networks, our proposed approach is demonstrated to be an effective and competitive method for improving the structural controllability of complex networks. Moreover, numerical simulations show that our method is near-optimal in optimizing structural controllability. Strikingly, compared to the original network, our method maintains the structural controllability of the network under attacks and cascading, indicating that the NEOM can also enhance the robustness of controllability of networks. These results alter the view of the nature of controllability in complex networks, change the understanding of structural controllability and affect the design of network models to control such networks.

Immediate effect of a functional wrist orthosis for children with cerebral palsy or brain injury: A randomized controlled trial.

PubMed

Jackman, Michelle; Novak, Iona; Lannin, Natasha; Galea, Claire

2017-10-28

Two-group randomized controlled trial. Upper limb orthoses worn during functional tasks are commonly used in pediatric neurologic rehabilitation, despite a paucity of high-level evidence. The purpose of this study was to investigate if a customized functional wrist orthosis, when placed on the limb, leads to an immediate improvement in hand function for children with cerebral palsy or brain injury. A 2-group randomized controlled trial involving 30 children was conducted. Participants were randomized to either receive a customized functional wrist orthosis (experimental, n = 15) or not receive an orthosis (control, n = 15). The box and blocks test was administered at baseline and repeated 1 hour after experimental intervention, with the orthosis on if randomized to the orthotic group. After intervention, there were no significant differences on the box and blocks test between the orthotic group (mean, 10.13; standard deviation, 11.476) and the no orthotic group (mean, 14.07; standard deviation, 11.106; t[28], -0.954; P = .348; and 95% confidence interval, -12.380 to 4.513). In contrast to the findings of previous studies, our results suggest that a functional wrist orthosis, when supporting the joint in a 'typical' position, may not lead to an immediate improvement in hand function. Wearing a functional wrist orthosis did not lead to an immediate improvement in the ability of children with cerebral palsy or brain injury to grasp and release. Further research is needed combining upper limb orthoses with task-specific training and measuring outcomes over the medium to long term. Copyright © 2017 Hanley & Belfus. All rights reserved.

Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention.

PubMed

Farquharson, Barbara; Johnston, Marie; Smith, Karen; Williams, Brian; Treweek, Shaun; Dombrowski, Stephan U; Dougall, Nadine; Abhyankar, Purva; Grindle, Mark

2017-05-01

To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text + visual and text-only) with usual care. Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for acute coronary syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions. A three-arm web-based, parallel randomized controlled trial of a theory-based intervention. The intervention comprises 12 behaviour change techniques systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n = 177 participants who have experienced acute coronary syndrome in the previous 6 months from a National Health Service Hospital. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care, ii) usual care plus text-only behaviour change technique-based intervention or iii) usual care plus text + visual behaviour change technique-based intervention. The primary outcome will be the change in intention to phone an ambulance immediately with symptoms of acute coronary syndrome ≥15-minute duration, assessed using two randomized series of eight scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care). Funding granted January 2014. Positive results changing intentions would lead to a randomized controlled trial of the behaviour change intervention in clinical practice, assessing patient delay in the event of actual symptoms. Registered at ClinicalTrials.gov: NCT02820103. © 2016 John Wiley & Sons Ltd.

Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports: Findings from a Randomized Controlled Effectiveness Trial

ERIC Educational Resources Information Center

Bradshaw, Catherine P.; Waasdorp, Tracy E.; Leaf, Philip J.

2015-01-01

School-Wide Positive Behavioral Interventions and Supports (SWPBIS; Sugai & Horner, 2006) is currently implemented in over 20,000 schools across the country with the goal of preventing disruptive behavior problems and enhancing the school climate. While previous studies have indicated significant main effects of SWPBIS on student outcomes, the…

Effect of Foster Care on Language Learning at Eight Years: Findings from the Bucharest Early Intervention Project

ERIC Educational Resources Information Center

Windsor, Jennifer; Moraru, Ana; Nelson, Charles A., III.; Fox, Nathan A.; Zeanah, Charles H.

2013-01-01

This study reports on language outcomes at eight years from the Bucharest Early Intervention Project, a randomized controlled study of foster care. We previously have shown that children placed in foster care by age two have substantially stronger preschool language outcomes than children placed later and children remaining in institutional care.…

A Randomized Controlled Trial of Acceptance-Based Behavior Therapy and Cognitive Therapy for Test Anxiety: A Pilot Study

ERIC Educational Resources Information Center

Brown, Lily A.; Forman, Evan M.; Herbert, James D.; Hoffman, Kimberly L.; Yuen, Erica K.; Goetter, Elizabeth M.

2011-01-01

Many university students suffer from test anxiety that is severe enough to impair performance. Given mixed efficacy results of previous cognitive-behavior therapy (CBT) trials and a theoretically driven rationale, an acceptance-based behavior therapy (ABBT) approach was compared to traditional CBT (i.e., Beckian cognitive therapy; CT) for the…

Randomized Controlled Double-Blind Trial of Optimal Dose Methylphenidate in Children and Adolescents with Severe Attention Deficit Hyperactivity Disorder and Intellectual Disability

ERIC Educational Resources Information Center

Simonoff, Emily; Taylor, Eric; Baird, Gillian; Bernard, Sarah; Chadwick, Oliver; Liang, Holan; Whitwell, Susannah; Riemer, Kirsten; Sharma, Kishan; Sharma, Santvana Pandey; Wood, Nicky; Kelly, Joanna; Golaszewski, Ania; Kennedy, Juliet; Rodney, Lydia; West, Nicole; Walwyn, Rebecca; Jichi, Fatima

2013-01-01

Background: Attention deficit hyperactivity disorder is increased in children with intellectual disability. Previous research has suggested stimulants are less effective than in typically developing children but no studies have titrated medication for individual optimal dosing or tested the effects for longer than 4 weeks. Method: One hundred and…

Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group

PubMed Central

Bourmaud, Aurelie; Soler-Michel, Patricia; Oriol, Mathieu; Regnier, Véronique; Tinquaut, Fabien; Nourissat, Alice; Bremond, Alain; Moumjid, Nora; Chauvin, Franck

2016-01-01

Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated. PMID:26883201

Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized, controlled trial.

PubMed

Michopoulos, Vasiliki; Mancini, Fulvia; Loucks, Tammy L; Berga, Sarah L

2013-06-01

To determine whether cognitive behavior therapy (CBT), which we had shown in a previous study to restore ovarian function in women with functional hypothalamic amenorrhea (FHA), could also ameliorate hypercortisolemia and improve other neuroendocrine and metabolic concomitants of in FHA. Randomized controlled trial. Clinical research center at an academic medical university. Seventeen women with FHA were randomized either to CBT or observation. CBT versus observation. Circulatory concentrations of cortisol, leptin, thyroid-stimulating hormone (TSH), total and free thyronine (T(3)), and total and free thyroxine (T(4)) before and immediately after completion of CBT or observation. (Each woman served as her own control.) Cognitive behavior therapy but not observation reduced cortisol levels in women with FHA. There were no changes in cortisol, leptin, TSH, T(3), or T(4) levels in women randomized to observation. Women treated with CBT showed increased levels of leptin and TSH, but their levels of T(3) and T(4) remained unchanged. In women with FHA, CBT ameliorated hypercortisolism and improved the neuroendocrine and metabolic concomitants of FHA while observation did not. We conclude that a cognitive, nonpharmacologic approach aimed at alleviating problematic attitudes not only can restore ovarian activity but also improve neuroendocrine and metabolic function in women with FHA. NCT01674426. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

A theory of eu-estrogenemia: a unifying concept

PubMed Central

Turner, Ralph J.; Kerber, Irwin J.

2017-01-01

Abstract Objective: The aim of the study was to propose a unifying theory for the role of estrogen in postmenopausal women through examples in basic science, randomized controlled trials, observational studies, and clinical practice. Methods: Review and evaluation of the literature relating to estrogen. Discussion: The role of hormone therapy and ubiquitous estrogen receptors after reproductive senescence gains insight from basic science models. Observational studies and individualized patient care in clinical practice may show outcomes that are not reproduced in randomized clinical trials. The understanding gained from the timing hypothesis for atherosclerosis, the critical window theory in neurosciences, randomized controlled trials, and numerous genomic and nongenomic actions of estrogen discovered in basic science provides new explanations to clinical challenges that practitioners face. Consequences of a hypo-estrogenemic duration in women's lives are poorly understood. The Study of Women Across the Nation suggests its magnitude is greater than was previously acknowledged. We propose that the healthy user bias was the result of surgical treatment (hysterectomy with oophorectomy) for many gynecological maladies followed by pharmacological and physiological doses of estrogen to optimize patient quality of life. The past decade of research has begun to demonstrate the role of estrogen in homeostasis. Conclusions: The theory of eu-estrogenemia provides a robust framework to unify the timing hypothesis, critical window theory, randomized controlled trials, the basic science of estrogen receptors, and clinical observations of patients over the past five decades. PMID:28562489

Meta-analysis of randomized controlled trials comparing 17α-hydroxyprogesterone caproate and vaginal progesterone for the prevention of recurrent spontaneous preterm delivery.

PubMed

Oler, Elizabeth; Eke, Ahizechukwu C; Hesson, Ashley

2017-07-01

Vaginal progesterone and 17α-hydroxyprogesterone (17α-OHP) are both used to prevent preterm delivery in women who have experienced spontaneous preterm delivery (SPTD) previously. Randomized trial data of the comparative effectiveness of these interventions have been mixed. To compare the efficacy of intramuscular 17α-OHP and vaginal progesterone in the prevention of recurrent SPTD. Cochrane Central Register of Controlled Trials, African Journals Online, Embase, Google Scholar, ISI Web of Science, LILACS, CINAHL, PubMed, and registers of ongoing trials were searched using keywords related to 17α-OHP, vaginal progesterone, and preterm delivery. Randomized controlled trials published between January 1, 1966, and November 30, 2016, comparing 17α-OHP and vaginal progesterone for the prevention of recurrent SPTD during singleton pregnancies were included. Study data were extracted and meta-analyses were performed when outcomes were comparable. The meta-analyses included data from three randomized trials. Lower rates of SPTD before 34 weeks (relative risk 0.71, 95% confidence interval 0.53-0.95) and before 32 weeks (relative risk 0.62, 95% confidence interval 0.40-0.94) of pregnancy were observed among patients treated with vaginal progesterone. Vaginal progesterone and 17α-OHP were comparable for the prevention of recurrent SPTD in singleton pregnancies; vaginal progesterone could be superior. © 2017 International Federation of Gynecology and Obstetrics.

Perceived control moderates the relationship between social capital and binge drinking: longitudinal findings from the Montreal Neighborhood Networks and Health Aging (MoNNET-HA) panel.

PubMed

Child, Stephanie; Stewart, Steven; Moore, Spencer

2017-02-01

Cross-sectional research suggests social capital has negative consequences for problem drinking behaviors. Previous studies have suggested psychosocial resources, including perceived control, may buffer this association. Little research has examined whether such relationships persist longitudinally. Random effects models examined between-person relationships among problem drinking, social capital, and perceived control, and whether perceived control moderated the relationship between social capital and drinking. Fixed effects models assessed whether social capital and perceived control were related to changes in problem drinking. Greater network capital and generalized trust predicted higher odds of binge drinking (RR = 1.08; 95% CI = 1.03-1.12 and RR = 1.23; 95% CI = 1.03-1.48, respectively). Perceived control moderated the positive association of network capital with binge drinking (RR = 0.91; 95% CI = 0.87-0.96). The present findings support previous notions about the complex role of social capital on health, and offer new insights on the role of perceived control on problem drinking. Copyright © 2016 Elsevier Inc. All rights reserved.

Visual Evoked Cortical Potential (VECP) Elicited by Sinusoidal Gratings Controlled by Pseudo-Random Stimulation

PubMed Central

Araújo, Carolina S.; Souza, Givago S.; Gomes, Bruno D.; Silveira, Luiz Carlos L.

2013-01-01

The contributions of contrast detection mechanisms to the visual cortical evoked potential (VECP) have been investigated studying the contrast-response and spatial frequency-response functions. Previously, the use of m-sequences for stimulus control has been almost restricted to multifocal electrophysiology stimulation and, in some aspects, it substantially differs from conventional VECPs. Single stimulation with spatial contrast temporally controlled by m-sequences has not been extensively tested or compared to multifocal techniques. Our purpose was to evaluate the influence of spatial frequency and contrast of sinusoidal gratings on the VECP elicited by pseudo-random stimulation. Nine normal subjects were stimulated by achromatic sinusoidal gratings driven by pseudo random binary m-sequence at seven spatial frequencies (0.4–10 cpd) and three stimulus sizes (4°, 8°, and 16° of visual angle). At 8° subtence, six contrast levels were used (3.12–99%). The first order kernel (K1) did not provide a consistent measurable signal across spatial frequencies and contrasts that were tested–signal was very small or absent–while the second order kernel first (K2.1) and second (K2.2) slices exhibited reliable responses for the stimulus range. The main differences between results obtained with the K2.1 and K2.2 were in the contrast gain as measured in the amplitude versus contrast and amplitude versus spatial frequency functions. The results indicated that K2.1 was dominated by M-pathway, but for some stimulus condition some P-pathway contribution could be found, while the second slice reflected the P-pathway contribution. The present work extended previous findings of the visual pathways contribution to VECP elicited by pseudorandom stimulation for a wider range of spatial frequencies. PMID:23940546

A Preliminary Randomized Controlled Trial of a Behavioral Exercise Intervention for Smoking Cessation

PubMed Central

Bloom, Erika Litvin; Strong, David R.; Riebe, Deborah; Marcus, Bess H.; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A.

2014-01-01

Introduction: Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. Methods: The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. Results: There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. Conclusions: The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. PMID:24812023

Enoxaparin and Aspirin Compared With Aspirin Alone to Prevent Placenta-Mediated Pregnancy Complications: A Randomized Controlled Trial.

PubMed

Haddad, Bassam; Winer, Norbert; Chitrit, Yvon; Houfflin-Debarge, Véronique; Chauleur, Céline; Bages, Karine; Tsatsaris, Vassilis; Benachi, Alexandra; Bretelle, Florence; Gris, Jean-Christophe; Bastuji-Garin, Sylvie

2016-11-01

To evaluate whether daily enoxaparin, added to low-dose aspirin, started before 14 weeks of gestation reduces placenta-mediated complications in pregnant women with previous severe preeclampsia diagnosed before 34 weeks of gestation. In this open-label multicenter randomized trial, we enrolled consenting pregnant women with previous severe preeclampsia diagnosed before 34 weeks of gestation, gestational age at randomization of 7-13 weeks, singleton pregnancy, and no plan for anticoagulation. Eligible patients were randomly assigned to a one-to-one ratio to receive daily either 4,000 international units enoxaparin plus 100 mg aspirin or 100 mg aspirin alone. Randomization was done by a web-based randomization system. The primary composite outcome comprised maternal death, perinatal death, preeclampsia, small for gestational age (less than the 10th percentile), and placental abruption. A sample size of 232 women equally divided into two groups was needed to detect a significant reduction in primary outcome from 55% in the aspirin group to 36.7% in the enoxaparin-aspirin group (α: 0.05, β: 0.8, two-sided). Between November 14, 2009, and February 21, 2015, 257 participants were enrolled. Baseline demographic and clinical factors were similar between groups. Eight women were excluded after randomization (six in the enoxaparin-aspirin group and two in the aspirin group), leaving 124 participants assigned to enoxaparin-aspirin and 125 to aspirin. Five participants were lost to follow-up (two in the enoxaparin-aspirin group and three in the aspirin group). There was no significant difference between the groups in the primary outcome: enoxaparin-aspirin 42 of 122 (34.4%) compared with aspirin alone 50 of 122 (41%) (relative risk 0.84, 95% confidence interval 0.61-1.16, P=.29). The occurrence of complications did not differ between the two groups. Antepartum prophylactic enoxaparin does not significantly reduce placenta-mediated complications in women receiving low-dose aspirin for previous severe preeclampsia diagnosed before 34 weeks of gestation. ClinicalTrials.gov, https://clinicaltrials.gov, NCT00986765.

Efficacy of homeopathically potentized antimony on blood coagulation. A randomized placebo controlled crossover trial.

PubMed

Heusser, Peter; Berger, Sarah; Stutz, Monika; Hüsler, André; Haeberli, André; Wolf, Ursula

2009-02-01

Homeopathically potentized antimony 6x is traditionally used in anthroposophic medicine for an alleged pro-coagulatory effect in bleeding disorders. However, the scientific evidence base is yet insufficient. Results of a previous in vitro study suggested a slight increase of maximal clot firmness (MCF) and a tendency towards a shorter clotting time (CT). The objective of this study was to investigate the pro-coagulatory effects of antimony in vivo, and possible unexpected or adverse events. A randomized placebo controlled double blind crossover study was carried out in 30 healthy volunteers (15 males, 15 females). Each participant received intravenously 10 ml of antimony 6x and placebo in a randomized order at an interval of 1 month. Thrombelastography (TEG) was carried out immediately before and 30 and 60 min after the injection. Statistically significant pro-coagulatory effects were observed 30 min after injection for CT in men (p = 0.0306), and for MCF in men and women combined (p = 0.0476). The effect of antimony was significantly larger on test day 1 than on test day 2, whereas the effect of placebo was similar on both test days. No unexpected adverse or adverse events causally related to antimony were observed. This study adds evidence to the hypothesis that homeopathically potentized antimony may be efficacious in vivo. The consistency of the results with previous in vitro results indicates an effect on MCF and CT. The in vivo application of antimony 6x is safe. Copyright (c) 2009 S. Karger AG, Basel.

Teacher-Child Interaction Training: A Pilot Study With Random Assignment.

PubMed

Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G

2015-07-01

Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.

Long-term outcomes and recurrence patterns of standard versus extended pancreatectomy for pancreatic head cancer: a multicenter prospective randomized controlled study.

PubMed

Jang, Jin-Young; Kang, Jae Seung; Han, Youngmin; Heo, Jin Seok; Choi, Seong Ho; Choi, Dong Wook; Park, Sang Jae; Han, Sung-Sik; Yoon, Dong Sup; Park, Joon Seong; Yu, Hee Chul; Kang, Koo Jeong; Kim, Sang Geol; Lee, Hongeun; Kwon, Wooil; Yoon, Yoo-Seok; Han, Ho-Seong; Kim, Sun-Whe

2017-07-01

Our previous randomized controlled trial revealed no difference in 2-year overall survival (OS) between extended and standard resection for pancreatic adenocarcinoma. The present study evaluated the 5-year OS and recurrence patterns according to the extent of pancreatectomy. Between 2006 and 2009, 169 consecutive patients were prospectively enrolled and randomized to standard (n = 83) or extended resection (n = 86) groups to compare 5-year OS rate, long-term recurrence patterns and factors associated with long-term survival. The surgical R0 rate was similar between the standard and extended groups (85.5 vs. 90.7%, P = 0.300). Five-year OS (18.4 vs. 14.4%, P = 0.388), 5-year disease-free survival (14.8 vs. 14.0%, P = 0.531), and overall recurrence rates (74.7 vs. 69.9%, P = 0.497) were not significantly different between the two groups, although the incidence of peritoneal seeding was higher in the extended group (25 vs. 8.1%, P = 0.014). Extended pancreatectomy does not have better short-term and long-term survival outcomes, and shows similar R0 rates and overall recurrence rates compared with standard pancreatectomy. Extended pancreatectomy does not have to be performed routinely for all cases of resectable pancreatic adenocarcinoma, especially considering its associated increased morbidity shown in our previous study. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Long-term effectiveness of bee venom acupuncture and physiotherapy in the treatment of adhesive capsulitis: a one-year follow-up analysis of a previous randomized controlled trial.

PubMed

Park, Yeon Cheol; Koh, Pil Seong; Seo, Byung Kwan; Lee, Jung Woo; Cho, Nam Su; Park, Hyung Soon; Park, Dong Suk; Baek, Yong Hyeon

2014-12-01

An earlier randomized controlled trial (RCT) study showed that bee venom acupuncture (BVA) in combination with physiotherapy can be more effective in functional improvement and pain reduction in patients with adhesive capsulitis (AC). The objective of the current study was to examine the long-term effect of BVA in combination with physiotherapy on AC of the shoulder. Retrospective 1-year follow-up analysis of a previous RCT using a telephone interview method. Outpatient joint center at the Gang Dong Kyung Hee University Hospital of Seoul, Republic of Korea. A total of 192 patients had been enrolled in the previous study, and 124 of these were excluded from the current study. Sixty-eight patients who had been treated with combined BVA and physiotherapy for AC of the shoulder for 2 months were interviewed at approximately 1 year after treatment by telephone. Sixty of 68 patients were included in the follow-up analysis. Twenty received BV 1 treatment (1:10,000 concentration BVA plus physiotherapy), 22 received BV 2 treatment (1:30,000 concentration BVA plus physiotherapy), and 18 received control treatment (normal saline injection plus physiotherapy). The primary outcome measure was Shoulder Pain And Disability Index (SPADI) score. Secondary outcome measure was score on verbal rating scale for pain and patient satisfaction. Baseline characteristics of the groups did not significantly differ. SPADI scores at 1 year significantly differed between the BV 1 group and the control group (p=0.043). No significant differences were found in pain verbal rating scores after 1 year. Treatment satisfaction with therapy was also assessed, and the BV 1 and BV 2 groups showed significantly greater satisfaction compared with the control group. BVA combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.

Subjective randomness as statistical inference.

PubMed

Griffiths, Thomas L; Daniels, Dylan; Austerweil, Joseph L; Tenenbaum, Joshua B

2018-06-01

Some events seem more random than others. For example, when tossing a coin, a sequence of eight heads in a row does not seem very random. Where do these intuitions about randomness come from? We argue that subjective randomness can be understood as the result of a statistical inference assessing the evidence that an event provides for having been produced by a random generating process. We show how this account provides a link to previous work relating randomness to algorithmic complexity, in which random events are those that cannot be described by short computer programs. Algorithmic complexity is both incomputable and too general to capture the regularities that people can recognize, but viewing randomness as statistical inference provides two paths to addressing these problems: considering regularities generated by simpler computing machines, and restricting the set of probability distributions that characterize regularity. Building on previous work exploring these different routes to a more restricted notion of randomness, we define strong quantitative models of human randomness judgments that apply not just to binary sequences - which have been the focus of much of the previous work on subjective randomness - but also to binary matrices and spatial clustering. Copyright © 2018 Elsevier Inc. All rights reserved.

Surgical novices randomized to train in two video games become more motivated during training in MIST-VR and GI Mentor II than students with no video game training.

PubMed

Hedman, Leif; Schlickum, Marcus; Felländer-Tsai, Li

2013-01-01

We investigated if engagement modes and perceived self-efficacy differed in surgical novices before and after randomized training in two different video games during five weeks, and a control group with no training. The control group expressed to a higher extent negative engagement modes during training in MIST-VR and GI Mentor II than the experimental groups. No statistically significant differences in self-efficacy were identified between groups. Both engagement modes and self-efficacy showed a positive correlation with previous and present video game experience. It is suggested that videogame training could have a framing effect on surgical simulator performance. EM and SE might be important intermediate variables between the strength of relationship between current videogame experience and simulator performance.

Evolution of Endovascular Therapy in Acute Stroke: Implications of Device Development

PubMed Central

Balasubramaian, Adithya; Mitchell, Peter; Dowling, Richard

2015-01-01

Intravenous thrombolysis is an effective treatment for acute ischaemic stroke. However, vascular recanalization rates remain poor especially in the setting of large artery occlusion. On the other hand, endovascular intra-arterial therapy addresses this issue with superior recanalization rates compared with intravenous thrombolysis. Although previous randomized controlled studies of intra-arterial therapy failed to demonstrate superiority, the failings may be attributed to a combination of inferior intra-arterial devices and suboptimal selection criteria. The recent results of several randomized controlled trials have demonstrated significantly improved outcomes, underpinning the advantage of newer intra-arterial devices and superior recanalization rates, leading to renewed interest in establishing intra-arterial therapy as the gold standard for acute ischaemic stroke. The aim of this review is to outline the history and development of different intra-arterial devices and future directions in research. PMID:26060800

A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up

PubMed Central

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M.; Waterworth, John A.

2015-01-01

This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary. PMID:25926790

Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru.

PubMed

Lanata, Claudio F; Andrade, Teresa; Gil, Ana I; Terrones, Cynthia; Valladolid, Omar; Zambrano, Betzana; Saville, Melanie; Crevat, Denis

2012-09-07

In a randomized, placebo-controlled, monocenter, observer blinded study conducted in an area where dengue is endemic, we assessed the safety and immunogenicity of a recombinant, live, attenuated, tetravalent dengue vaccine candidate (CYD-TDV) in 2-11 year-olds with varying levels of pre-existing yellow-fever immunity due to vaccination 1-7 years previously. 199 children received 3 injections of CYD-TDV (months 0, 6 and 12) and 99 received placebo (months 0 and 6) or pneumococcal polysaccharide vaccine (month 12). One month after the third dengue vaccination, serotype specific neutralizing antibody GMTs were in the range of 178-190 (1/dil) (versus 16.7-38.1 in the control group), a 10-20 fold-increase from baseline, and 94% of vaccines were seropositive to all four serotypes (versus 39% in the control group). There were no vaccine-related SAEs. The observed reactogenicity profile was consistent with phase I studies, with severity grade 1-2 injection site pain, headache, malaise and fever most frequently reported and no increase after subsequent vaccinations. Virologically confirmed dengue cases were seen after completion of the 3 doses: 1 in the CYD-TDV group (N=199), and 3 in the control group (N=99). A 3-dose regimen of CYD-TDV had a good safety profile in 2-11 year olds with a history of YF vaccination and elicited robust antibody responses that were balanced against the four serotypes. Copyright © 2012 Elsevier Ltd. All rights reserved.

A randomized controlled trial of brain training with non-action video games in older adults: results of the 3-month follow-up.

PubMed

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Toril, Pilar; Pita, Carmen; Laura, Ponce de León; Reales, José M; Waterworth, John A

2015-01-01

This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training sessions with selected games from a commercial package on several age-declining cognitive functions and subjective wellbeing after a 3-month no-contact period. Two groups of cognitively normal older adults participated in both the post-training (posttest) and the present follow-up study, the experimental group who received training and the control group who attended several meetings with the research team during the study but did not receive training. Groups were similar at baseline on demographics, vocabulary, global cognition, and depression status. Significant improvements in the trained group, and no variation in the control group had been previously found at posttest, in processing speed, attention and visual recognition memory, as well as in two dimensions of subjective wellbeing. In the current study, improvement from baseline to 3 months follow-up was found only in wellbeing (Affection and Assertivity dimensions) in the trained group whereas there was no change in the control group. Previous significant improvements in processing speed, attention and spatial memory become non-significant after the 3-month interval. Training older adults with non-action video games enhanced aspects of cognition just after training but this effect disappeared after a 3-month no-contact follow-up period. Cognitive plasticity can be induced in older adults by training, but to maintain the benefits periodic boosting sessions would be necessary.

Association of Airborne Microorganisms in the Operating Room With Implant Infections: A Randomized Controlled Trial.

PubMed

Darouiche, Rabih O; Green, David M; Harrington, Melvyn A; Ehni, Bruce L; Kougias, Panagiotis; Bechara, Carlos F; O'Connor, Daniel P

2017-01-01

OBJECTIVE To evaluate the association of airborne colony-forming units (CFU) at incision sites during implantation of prostheses with the incidence of either incisional or prosthesis-related surgical site infections. DESIGN Randomized, controlled trial. SETTING Primary, public institution. PATIENTS Three hundred patients undergoing total hip arthroplasty, instrumented spinal procedures, or vascular bypass graft implantation. METHODS Patients were randomly assigned in a 1:1 ratio to either the intervention group or the control group. A novel device (Air Barrier System), previously shown to reduce airborne CFU at incision sites, was utilized in the intervention group. Procedures assigned to the control group were performed without the device, under routine operating room atmospheric conditions. Patients were followed up for 12 months to determine whether airborne CFU levels at the incision sites predicted the incidence of incisional or prosthesis-related infection. RESULTS Data were available for 294 patients, 148 in the intervention group and 146 in the control group. CFU density at the incision site was significantly lower in the intervention group than in the control group (P<.001). The density of airborne CFU at the incision site during the procedures was significantly related to the incidence of implant infection (P=.021). Airborne CFU densities were 4 times greater in procedures with implant infection versus no implant infection. All 4 of the observed prosthesis infections occurred in the control group. CONCLUSION Reduction of airborne CFU specifically at the incision site during operations may be an effective strategy to reduce prosthesis-related infections. clinicaltrials.gov Identifier: NCT01610271 Infect Control Hosp Epidemiol 2016;1-8.

Validity and power of association testing in family-based sampling designs: evidence for and against the common wisdom.

PubMed

Knight, Stacey; Camp, Nicola J

2011-04-01

Current common wisdom posits that association analyses using family-based designs have inflated type 1 error rates (if relationships are ignored) and independent controls are more powerful than familial controls. We explore these suppositions. We show theoretically that family-based designs can have deflated type-error rates. Through simulation, we examine the validity and power of family designs for several scenarios: cases from randomly or selectively ascertained pedigrees; and familial or independent controls. Family structures considered are as follows: sibships, nuclear families, moderate-sized and extended pedigrees. Three methods were considered with the χ(2) test for trend: variance correction (VC), weighted (weights assigned to account for genetic similarity), and naïve (ignoring relatedness) as well as the Modified Quasi-likelihood Score (MQLS) test. Selectively ascertained pedigrees had similar levels of disease enrichment; random ascertainment had no such restriction. Data for 1,000 cases and 1,000 controls were created under the null and alternate models. The VC and MQLS methods were always valid. The naïve method was anti-conservative if independent controls were used and valid or conservative in designs with familial controls. The weighted association method was generally valid for independent controls, and was conservative for familial controls. With regard to power, independent controls were more powerful for small-to-moderate selectively ascertained pedigrees, but familial and independent controls were equivalent in the extended pedigrees and familial controls were consistently more powerful for all randomly ascertained pedigrees. These results suggest a more complex situation than previously assumed, which has important implications for study design and analysis. © 2011 Wiley-Liss, Inc.

The Impact of Tai Chi Exercise on Self-Efficacy, Social Support, and Empowerment in Heart Failure: Insights from a Qualitative Sub-Study from a Randomized Controlled Trial.

PubMed

Yeh, Gloria Y; Chan, Caroline W; Wayne, Peter M; Conboy, Lisa

2016-01-01

To qualitatively explore perceived physical and psychosocial effects and overall patient experience associated with a 12-week tai chi (TC) intervention and an education group in a clinical trial of patients with chronic heart failure (HF). We randomized 100 patients with chronic systolic HF (NYHA Class 1-3, ejection fraction≤40%) to a 12-week group TC program or an education control. At 12-weeks, semi-structured interviews were conducted on a random subset (n = 32; n = 17 in TC, n = 15 in control), audiorecorded and transcribed verbatim. Two independent reviewers extracted information using grounded-theory methods for emergent themes. We explored similarities and differences in themes/sub-themes between the groups, and examined qualitative association with changes from baseline to post-intervention in previously reported quantitative measures (e.g., Minnesota Living with HF, Cardiac Exercise Self Efficacy and Profile of Mood States). The mean age (±SD) of participants was 68±9 years, baseline ejection fraction 29±7%, and median New York Heart Association class 2 HF. We idenitifed themes related to the patient's experience of illness, perceptions of self, and relationship to others. Specific psychosocial and physical benefits were described. Common themes emerged from both groups including: social support and self-efficacy related to activity/exercise and diet. The tai chi group, however, also exhibited a more global empowerment and perceived control. Additional themes in TC included mindfulness/self-awareness, decreased stress reactivity, and renewed social role. These themes mirrored improvements in previously reported quantitative measures (quality-of-life, self-efficacy, and mood) in TC compared to control. Patients in TC also reported physical benefits (e.g., decreased pain, improved energy, endurance, flexibility). Positive themes emerged from both groups, although there were qualitative differences in concepts of self-efficacy and perceived control between groups. Those in tai chi reported not only self efficacy and social support, but overall empowerment with additional gains such as internal locus of control, self-awareness and stress management. Future studies of mind-body exercise might further examine perceived control, self-efficacy, and locus-of-control as potential mediators of effect.

Do government brochures affect physical activity cognition? A pilot study of Canada's physical activity guide to healthy active living.

PubMed

Kliman, Aviva M; Rhodes, Ryan

2008-08-01

Health Canada has published national physical activity (PA) guidelines, which are included in their 26-page Physical Activity Guide to Healthy Active Living (CPAG). To date, the use of CPAG as a motivational instrument for PA promotion has not been evaluated. The purpose of this study was to determine whether reading CPAG 1) increased motivational antecedents to engage in regular PA, and 2) increased regular PA intention and behaviour over 1 month. Participants included 130 randomly sampled Canadian adults (18 years or older) who were randomly mailed pack ages consisting of either 1) a questionnaire and a copy of CPAG, or 2) a questionnaire. Questionnaire items pertained to participants' sociodemographics, previous PA behaviours (Godin Leisure-Time Questionnaire) and PA motivation (theory of planned behaviour). Participants were then sent a follow-up questionnaire pertaining to their PA behaviours throughout the previous month. Results revealed significant interactions between the guide condition and previous activity status on instrumental behavioural beliefs about strength activities and subjective norms about endurance activities (p < 0.05), but all other factors were not significantly different. It was concluded that among previously inactive people, receiving this guide may change some informational/motivational constructs, but key motivational antecedents (affective attitude, perceived behavioural control) and outcomes (intention, behaviour) seem unaffected.

One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure.

PubMed

Mann, Douglas L; Lee, Randall J; Coats, Andrew J S; Neagoe, Gheorghe; Dragomir, Dinu; Pusineri, Enrico; Piredda, Massimo; Bettari, Luca; Kirwan, Bridget-Anne; Dowling, Robert; Volterrani, Maurizio; Solomon, Scott D; Sabbah, Hani N; Hinson, Andy; Anker, Stefan D

2016-03-01

AUGMENT-HF was an international, multicentre, prospective, open-label, randomized, controlled evaluation testing the hypothesis that Algisyl (injectable calcium alginate hydrogel) is superior to standard medical therapy (SMT) for improving functional capacity and clinical outcomes in patients with advanced heart failure (HF). We previously reported results following 6 months of follow-up. This report presents the results from 1 year of extended follow up for this clinical trial. We enrolled 78 patients with advanced HF, randomized (1:1), to Algisyl with SMT or SMT alone as previously reported. Patient inclusion criteria were LVEF ≤35%, peak VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m(2) (LVEDD/body surface area). Patients must have been on stable, evidence-based therapy for HF. A total of 58 patients, mean age 62.3 ± 9.6 years, with ischaemic (57.7%) or non-ischaemic (42.3%) HF completed 12 months of follow-up. Treatment with Algisyl was associated with improved peak VO2 at 12 months; treatment effect vs. control of +2.10 mL/kg/min (95% confidence interval 0.96-3.24, P < 0.001). Statistically significant improvements were observed for VO2 at anaerobic threshold, 6-min walk test distance, and NYHA functional class (all P < 0.001). Through 12 months of follow-up there were 4 (10.5%) deaths in the control group and 9 (22.5%) deaths in the Algisyl group. Algisyl in addition to SMT was more effective than SMT alone for providing sustained 1-year benefits in exercise capacity, symptoms, and clinical status for patients with advanced HF. These data support larger clinical evaluations of this novel therapy. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

Retention of blinding at follow-up in a randomized clinical study using a sham-control cervical manipulation procedure for neck pain: secondary analyses from a randomized clinical study.

PubMed

Vernon, Howard; Triano, John T; Soave, David; Dinulos, Maricelle; Ross, Kim; Tran, Steven

2013-10-01

Participants in clinical trials of spinal manipulation have not been rigorously blinded to group assignment. This study reports on secondary analyses of the retention of participant blinding beyond the immediate posttreatment time frame following a single-session, randomized clinical study. A novel control cervical manipulation procedure that has previously been shown to be therapeutically inert was contrasted with a typical manipulation procedure. A randomized clinical study of a single session of typical vs sham-control manipulation in patients with chronic neck pain was conducted. Findings of self-reported group registration at 24 to 48 hours posttreatment were computed. The Blinding Index (BI) of Bang et al was then applied to both the immediate and post-24- to 48-hour results. Twenty-four to 48 hours after treatment, 94% and 22% of participants in the typical and control groups, respectively, correctly identified their group assignment. When analyzed with the BI of Bang et al, the immediate posttreatment BI for the group receiving a typical manipulation was 0.22 (95% confidence interval [CI], -0.03 to 0.47); for the group receiving a control manipulation, it was 0.19 (95% CI, -0.06 to 0.43). The BI at post-24 hours was as follows: typical = 0.75 (95% CI, 0.59-0.91) and control = -0.34 (95% CI, -0.58 to -0.11). This study found that the novel sham-control cervical manipulation procedure may be effective in blinding sham group allocation up to 48 hours posttreatment. It appears that, at 48 hours posttreatment, the modified form of the typical cervical manipulation was not. The sham-control procedure appears to be a promising procedure for future clinical trials. © 2013. Published by National University of Health Sciences All rights reserved.

Goal selection versus process control while learning to use a brain-computer interface

NASA Astrophysics Data System (ADS)

Royer, Audrey S.; Rose, Minn L.; He, Bin

2011-06-01

A brain-computer interface (BCI) can be used to accomplish a task without requiring motor output. Two major control strategies used by BCIs during task completion are process control and goal selection. In process control, the user exerts continuous control and independently executes the given task. In goal selection, the user communicates their goal to the BCI and then receives assistance executing the task. A previous study has shown that goal selection is more accurate and faster in use. An unanswered question is, which control strategy is easier to learn? This study directly compares goal selection and process control while learning to use a sensorimotor rhythm-based BCI. Twenty young healthy human subjects were randomly assigned either to a goal selection or a process control-based paradigm for eight sessions. At the end of the study, the best user from each paradigm completed two additional sessions using all paradigms randomly mixed. The results of this study were that goal selection required a shorter training period for increased speed, accuracy, and information transfer over process control. These results held for the best subjects as well as in the general subject population. The demonstrated characteristics of goal selection make it a promising option to increase the utility of BCIs intended for both disabled and able-bodied users.

School-based prevention of depressive symptoms: A randomized controlled study of the effectiveness and specificity of the Penn Resiliency Program.

PubMed

Gillham, Jane E; Reivich, Karen J; Freres, Derek R; Chaplin, Tara M; Shatté, Andrew J; Samuels, Barbra; Elkon, Andrea G L; Litzinger, Samantha; Lascher, Marisa; Gallop, Robert; Seligman, Martin E P

2007-02-01

The authors investigated the effectiveness and specificity of the Penn Resiliency Program (PRP; J. E. Gillham, L. H. Jaycox, K. J. Reivich, M. E. P. Seligman, & T. Silver, 1990), a cognitive-behavioral depression prevention program. Children (N = 697) from 3 middle schools were randomly assigned to PRP, Control (CON), or the Penn Enhancement Program (PEP; K. J. Reivich, 1996; A. J. Shatté, 1997), an alternate intervention that controls for nonspecific intervention ingredients. Children's depressive symptoms were assessed through 3 years of follow-up. There was no intervention effect on average levels of depressive symptoms in the full sample. Findings varied by school. In 2 schools, PRP significantly reduced depressive symptoms across the follow-up relative to both CON and PEP. In the 3rd school, PRP did not prevent depressive symptoms. The authors discuss the findings in relation to previous research on PRP and the dissemination of prevention programs. Copyright 2007 APA, all rights reserved.

School-Based Prevention of Depressive Symptoms: A Randomized Controlled Study of the Effectiveness and Specificity of the Penn Resiliency Program

PubMed Central

Gillham, Jane E.; Reivich, Karen J.; Freres, Derek R.; Chaplin, Tara M.; Shatté, Andrew J.; Samuels, Barbra; Elkon, Andrea G. L.; Litzinger, Samantha; Lascher, Marisa; Gallop, Robert; Seligman, Martin E. P.

2015-01-01

The authors investigated the effectiveness and specificity of the Penn Resiliency Program (PRP; J. E. Gillham, L. H. Jaycox, K. J. Reivich, M. E. P. Seligman, & T. Silver, 1990), a cognitive–behavioral depression prevention program. Children (N = 697) from 3 middle schools were randomly assigned to PRP, Control (CON), or the Penn Enhancement Program (PEP; K. J. Reivich, 1996; A. J. Shatté, 1997), an alternate intervention that controls for nonspecific intervention ingredients. Children’s depressive symptoms were assessed through 3 years of follow-up. There was no intervention effect on average levels of depressive symptoms in the full sample. Findings varied by school. In 2 schools, PRP significantly reduced depressive symptoms across the follow-up relative to both CON and PEP. In the 3rd school, PRP did not prevent depressive symptoms. The authors discuss the findings in relation to previous research on PRP and the dissemination of prevention programs. PMID:17295559

Therapeutic Exercise Training to Reduce Chronic Headache in Working Women: Design of a Randomized Controlled Trial.

PubMed

Rinne, Marjo; Garam, Sanna; Häkkinen, Arja; Ylinen, Jari; Kukkonen-Harjula, Katriina; Nikander, Riku

2016-05-01

Cervicogenic headache and migraine are common causes of visits to physicians and physical therapists. Few randomized trials utilizing active physical therapy and progressive therapeutic exercise have been previously published. The existing evidence on active treatment methods supports a moderate effect on cervicogenic headache. The aim of this study is to investigate whether a progressive, group-based therapeutic exercise program decreases the intensity and frequency of chronic headache among women compared with a control group receiving a sham dose of transcutaneous electrical nerve stimulation (TENS) and stretching exercises. A randomized controlled trial with 6-month intervention and follow-up was developed. The participants were randomly assigned to either a treatment group or a control group. The study is being conducted at 2 study centers. The participants are women aged 18 to 60 years with chronic cervicogenic headache or migraine. The treatment group's exercise program consisted of 6 progressive therapeutic exercise modules, including proprioceptive low-load progressive craniocervical and cervical exercises and high-load exercises for the neck muscles. The participants in the control group received 6 individually performed sham TENS treatment sessions. The primary outcome is the intensity of headache. The secondary outcomes are changes in frequency and duration of headache, neck muscle strength, neck and shoulder flexibility, impact of headache on daily life, neck disability, fear-avoidance beliefs, work ability, and quality of life. Between-group differences will be analyzed separately at 6, 12, and 24 months with generalized linear mixed models. In the case of count data (eg, frequency of headache), Poisson or negative binomial regression will be used. The therapists are not blinded. The effects of specific therapeutic exercises on frequency, intensity, and duration of chronic headache and migraine will be reported. © 2016 American Physical Therapy Association.

Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial.

PubMed

Fulkerson, Jayne A; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y

2015-12-15

Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011-2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

A Randomized Clinical Trial of Cogmed Working Memory Training in School-Age Children with ADHD: A Replication in a Diverse Sample Using a Control Condition

ERIC Educational Resources Information Center

Chacko, A.; Bedard, A. C.; Marks, D. J.; Feirsen, N.; Uderman, J. Z.; Chimiklis, A.; Rajwan, E.; Cornwell, M.; Anderson, L.; Zwilling, A.; Ramon, M.

2014-01-01

Background: Cogmed Working Memory Training (CWMT) has received considerable attention as a promising intervention for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children. At the same time, methodological weaknesses in previous clinical trials call into question reported efficacy of CWMT. In particular, lack of equivalence…

Effect of Strength Training on Rate of Force Development in Older Women

ERIC Educational Resources Information Center

Gurjao, Andre Luiz Demantova; Gobbi, Lilian Teresa Bucken; Carneiro, Nelson Hilario; Goncalves, Raquel; Ferreira de Moura, Rodrigo; Cyrino, Edilson Serpeloni; Altimari, Leandro Ricardo; Gobbi, Sebastiao

2012-01-01

We analyzed the effect of an 8-week strength training (ST) program on the rate of force development (RFD) and electromyographic activity (EMG) in older women. Seventeen women (M age = 63.4 years, SD = 4.9) without previous ST experience were randomly assigned to either a control (n = 7) or training (n = 10) group. A leg-press isometric test was…

Training Mispronunciation Correction and Word Meanings Improves Children's Ability to Learn to Read Words

ERIC Educational Resources Information Center

Dyson, Hannah; Best, Wendy; Solity, Jonathan; Hulme, Charles

2017-01-01

Previous research has suggested that learning to read irregular words depends upon knowledge of a word's meaning and the ability to correct imperfect decoding attempts by reference to the known pronunciations of a word. In an experimental training study, 84 children ages 5-7 years were randomly assigned to an intervention or control group.…

Photodynamic therapy as an adjunct to non-surgical periodontal treatment: a randomized, controlled clinical trial.

PubMed

Christodoulides, Nicos; Nikolidakis, Dimitris; Chondros, Panagiotis; Becker, Jürgen; Schwarz, Frank; Rössler, Ralf; Sculean, Anton

2008-09-01

Recent preclinical and clinical data have suggested a potential benefit of photodynamic therapy (PDT) in the treatment of periodontitis. However, there are very limited data from controlled clinical trials evaluating the effect of PDT in the treatment of periodontitis. The aim of this study was to evaluate the clinical and microbiologic effects of the adjunctive use of PDT to non-surgical periodontal treatment. Twenty-four subjects with chronic periodontitis were randomly treated with scaling and root planing followed by a single episode of PDT (test) or scaling and root planing alone (control). Full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), gingival recession, and clinical attachment level (CAL) were measured at baseline and 3 and 6 months after therapy. Primary outcome variables were changes in PD and CAL. Microbiologic evaluation of Aggregatibacter actinomycetemcomitans (previously Actinobacillus actinomycetemcomitans), Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia (previously T. forsythensis), Treponema denticola, Parvimonas micra (previously Peptostreptococcus micros or Micromonas micros), Fusobacterium nucleatum, Campylobacter rectus, Eubacterium nodatum, Eikenella corrodens, and Capnocytophaga spp. was performed at baseline and 3 and 6 months following therapy by using a commercially available polymerase chain reaction test. At 3 and 6 months after treatment, there were no statistically significant differences between the groups with regard to CAL, PD, FMPS, or microbiologic changes. At 3 and 6 months, a statistically significantly greater improvement in FMBS was found in the test group. The additional application of a single episode of PDT to scaling and root planing failed to result in an additional improvement in terms of PD reduction and CAL gain, but it resulted in a significantly higher reduction in bleeding scores compared to scaling and root planing alone.

Effects of Barbell Deadlift Training on Submaximal Motor Unit Firing Rates for the Vastus Lateralis and Rectus Femoris

PubMed Central

Stock, Matt S.; Thompson, Brennan J.

2014-01-01

Previous investigations that have studied motor unit firing rates following strength training have been limited to small muscles, isometric training, or interventions involving exercise machines. We examined the effects of ten weeks of supervised barbell deadlift training on motor unit firing rates for the vastus lateralis and rectus femoris during a 50% maximum voluntary contraction (MVC) assessment. Twenty-four previously untrained men (mean age  = 24 years) were randomly assigned to training (n = 15) or control (n = 9) groups. Before and following the intervention, the subjects performed isometric testing of the right knee extensors while bipolar surface electromyographic signals were detected from the two muscles. The signals were decomposed into their constituent motor unit action potential trains, and motor units that demonstrated accuracy levels less than 92.0% were not considered for analysis. One thousand eight hundred ninety-two and 2,013 motor units were examined for the vastus lateralis and rectus femoris, respectively. Regression analyses were used to determine the linear slope coefficients (pulses per second [pps]/% MVC) and y-intercepts (pps) of the mean firing rate and firing rate at recruitment versus recruitment threshold relationships. Deadlift training significantly improved knee extensor MVC force (Cohen's d = .70), but did not influence force steadiness. Training had no influence on the slopes and y-intercepts for the mean firing rate and firing rate at recruitment versus recruitment threshold relationships. In agreement with previous cross-sectional comparisons and randomized control trials, our findings do not support the notion that strength training affects the submaximal control of motor units. PMID:25531294

The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial.

PubMed

Su, Tongsheng; Zhou, Jing; Liu, Zhishun; Chen, Yuelai; Zhang, Wei; Chu, Haoran; Luo, Qiong; Lu, Jin; An, Junming; Liu, Baoyan

2015-02-08

Previous research has shown that electroacupuncture therapy has a potential therapeutic effect for simple female stress urinary incontinence. In this study, pelvic floor muscle training, the first-line treatment for stress urinary incontinence in women based on meta-analysis of numerous randomized control trials and recommended by international clinical practice, is used as a control group to demonstrate whether electroacupuncture therapy is a better method for female stress urinary incontinence. A randomized controlled trial has been designed to evaluate the therapeutic benefit of electroacupuncture for female stress urinary incontinence compared with pelvic floor muscle training. The safety of electroacupuncture and patient compliance will also be evaluated. Untoward reaction to the electroacupuncture, including a broken needle, fainting on acupuncture, or pain during acupuncture, will be recorded and the therapy will be stopped if an untoward reaction occurs. After we have received full ethical approval and patient consent, participants will be randomized to receive a series of 24 electroacupuncture or pelvic floor muscle training interventions. The frequency and amount of leakage will be measured as the primary outcome parameters. Secondary outcome parameters include the 1-hour pad test, the short-form of the International Consultation on Incontinence Questionnaire, patient subjective effectiveness evaluation, weekly usage of pad, and usage of specialty therapy for female stress urinary incontinence. This trial will help to determine whether electroacupuncture is a more effective treatment than pelvic floor muscle training for patients with female stress urinary incontinence. ClinicalTrials.gov NCT01940432 (12 September 2013).

Examination of Cognitive Function During Six Months of Calorie Restriction: Results of a Randomized Controlled Trial

PubMed Central

Martin, Corby K.; Anton, Stephen D.; Han, Hongmei; York-Crowe, Emily; Redman, Leanne M.; Ravussin, Eric; Williamson, Donald A.

2009-01-01

Background Calorie restriction increases longevity in many organisms, and calorie restriction or its mimetic might increase longevity in humans. It is unclear if calorie restriction/dieting contributes to cognitive impairment. During this randomized controlled trial, the effect of 6 months of calorie restriction on cognitive functioning was tested. Methods Participants (n = 48) were randomized to one of four groups: (1) control (weight maintenance), (2) calorie restriction (CR; 25% restriction), (3) CR plus structured exercise (CR + EX, 12.5% restriction plus 12.5% increased energy expenditure via exercise), or (4) low-calorie diet (LCD; 890 kcal/d diet until 15% weight loss, followed by weight maintenance). Cognitive tests (verbal memory, visual memory, attention/concentration) were conducted at baseline and months 3 and 6. Mixed linear models tested if cognitive function changed significantly from baseline to months 3 and 6, and if this change differed by group. Correlation analysis was used to determine if average daily energy deficit (quantified from change in body energy stores) was associated with change in cognitive test performance for the three dieting groups combined. Results No consistent pattern of verbal memory, visual retention/memory, or attention/concentration deficits emerged during the trial. Daily energy deficit was not significantly associated with change in cognitive test performance. Conclusions This randomized controlled trial suggests that calorie restriction/dieting was not associated with a consistent pattern of cognitive impairment. These conclusions must be interpreted in the context of study limitations, namely small sample size and limited statistical power. Previous reports of cognitive impairment might reflect sampling biases or information processing biases. PMID:17518698

Effect of low-level laser therapy (LLLT) and light-emitting diodes (LEDT) applied during combined training on performance and post-exercise recovery: protocol for a randomized placebo-controlled trial.

PubMed

Machado, Aryane Flauzino; Micheletti, Jéssica Kirsch; Vanderlei, Franciele Marques; Nakamura, Fabio Yuzo; Leal-Junior, Ernesto Cesar Pinto; Netto Junior, Jayme; Pastre, Carlos Marcelo

Previous studies have shown positive results of phototherapy for improving performance and accelerating recovery; however, the effects of phototherapy during training and after a primary adaptation remain unclear. The aim of this randomized controlled trial is to analyze the effects of phototherapy and combined training on clinical, functional, and psychological outcomes and on vascular endothelial growth factor. This randomized placebo-controlled trial by stratified sample will involve 45 healthy male participants. In phase 1, the participants will undergo six weeks of combined training (sprints and squats). In phase 2, participants will be allocated through stratified randomization (based on adaptation capacity) into three groups: active phototherapy group (AG), placebo group (PG), and non-treatment control group (CG). A new six-week training program will then start and the participants will receive the recovery strategy between sprints and squats. The primary outcome will be maximal isometric contraction. The secondary outcomes include strength and power testing, maximal incremental test, squat jump, sprint test, muscle soreness, pain threshold, perceptions of exertion and recovery, psychological questionnaire, and vascular endothelial growth factor. This will be the first trial to include phototherapy during training. We believe that this strategy will combine the ergogenic and prophylactic effects in the same session. Furthermore, an application protocol performed after primary adaptation may reflect the real effect of the technique. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Stroke prevention by cilostazol in patients with atherothrombosis: meta-analysis of placebo-controlled randomized trials.

PubMed

Uchiyama, Shinichiro; Demaerschalk, Bart M; Goto, Shinya; Shinohara, Yukito; Gotoh, Fumio; Stone, William M; Money, Samuel R; Kwon, Sun Uck

2009-01-01

Cilostazol is an antiplatelet agent that inhibits phosphodiesterase III in platelets and vascular endothelium. Previous randomized controlled trials of cilostazol for prevention of cerebrovascular events have garnered mixed results. We performed a systematic review and meta-analysis of the randomized clinical trials in patients with atherothrombotic diseases to determine the effects of cilostazol on cerebrovascular, cardiac, and all vascular events, and on all major hemorrhagic events. Relevant trials were identified by searching MEDLINE, EMBASE, and the Cochrane Controlled Trial Registry for titles and abstracts. Data from 12 randomized controlled trials, involving 5674 patients, were analyzed for end points of cerebrovascular, cardiac, and major bleeding events. Searching, determination of eligibility, data extraction, and meta-analyses were conducted by multiple independent investigators. Data were available in 3782, 1187, and 705 patients with peripheral arterial disease, cerebrovascular disease, and coronary stenting, respectively. Incidence of total vascular events was significantly lower in the cilostazol group compared with the placebo group (relative risk [RR], 0.86; 95% confidence interval [CI], 0.74-0.99; P=.038). This was particularly influenced by a significant decrease of incidence of cerebrovascular events in the cilostazol group (RR, 0.58; 95% CI, 0.43-0.78; P < .001). There was no significant intergroup difference in incidence of cardiac events (RR, 0.99; 95% CI, 0.83-1.17; P=.908) and serious bleeding complications (RR, 1.00; 95% CI, 0.66-1.51; P=.996). This first meta-analysis of cilostazol in patients with atherothrombosis demonstrated a significant risk reduction for cerebrovascular events, with no associated increase of bleeding risk.

Randomized controlled trial of a behavioral intervention targeting symptoms and physical activity in multiple sclerosis.

PubMed

Pilutti, L A; Dlugonski, D; Sandroff, B M; Klaren, R; Motl, R W

2014-04-01

Exercise training is beneficial, but most persons with multiple sclerosis (MS) are sedentary and physically inactive. This has prompted a new focus on the promotion of lifestyle physical activity in MS. We previously designed, tested, and refined a behavioral intervention delivered through the Internet that successfully increased lifestyle physical activity in MS, but have not evaluated the effects on secondary symptomatic and health-related quality of life (HRQOL) outcomes. We conducted a 6-month randomized controlled trial (RCT) that examined the efficacy of an Internet-delivered, behavioral intervention for improving outcomes of fatigue, depression, anxiety, pain, sleep quality, and HRQOL in 82 ambulatory persons with MS. The secondary aim was to replicate previous results regarding change in free-living physical activity. There was a significant and positive effect of the intervention on fatigue severity (p=.001, η ρ (2)=.15) and its physical impact (p=.008, η ρ (2)=.09), depression (p=.006, η ρ (2)=.10), and anxiety (p=.006, η ρ (2)=.10). There were non-significant improvements in pain (p=.08, η ρ (2)=.04), sleep quality (p=.06, η ρ (2)=.05), and physical HRQOL (p=.06, η ρ (2)=.05). We replicated our previous results by demonstrating an increase in self-reported physical activity (p=.001, η ρ (2)=.13). Our results support behavioral interventions targeting lifestyle physical activity as an alternative approach for managing symptoms in MS.

Effect of dietary fiber on circulating C-reactive protein in overweight and obese adults: a meta-analysis of randomized controlled trials.

PubMed

Jiao, Jun; Xu, Jia-Ying; Zhang, Weiguo; Han, Shufen; Qin, Li-Qiang

2015-02-01

Previous studies suggested that dietary fiber intake may have a lowing effect on circulating C-reactive protein (CRP) level, a sensitive marker of inflammation, in overweight/obese adults with inconsistent results. A literature search was performed in April 2014 for related randomized controlled trials (RCTs) and meta-analysis was conducted. Meta-analysis including 14 RCTs showed that intervention with dietary fiber or fiber-rich food, compared with control, produced a slight, but significant reduction of 0.37 mg/L (95% CI -0.74, 0) in circulating CRP level among this population. Subgroup analyses showed that such a significant reduction was only observed after combining studies where the total fiber intake was 8 g/d higher in the intervention group than in the control group. No obvious heterogeneity and publication bias were found in the meta-analysis. In conclusion, this meta-analysis provides evidence that dietary fiber or food naturally rich in fiber has beneficial effects on circulating CRP level in overweight/obese adults.

Personalized contact strategies and predictors of time to survey completion: analysis of two sequential randomized trials.

PubMed

Dinglas, Victor D; Huang, Minxuan; Sepulveda, Kristin A; Pinedo, Mariela; Hopkins, Ramona O; Colantuoni, Elizabeth; Needham, Dale M

2015-01-09

Effective strategies for contacting and recruiting study participants are critical in conducting clinical research. In this study, we conducted two sequential randomized controlled trials of mail- and telephone-based strategies for contacting and recruiting participants, and evaluated participant-related variables' association with time to survey completion and survey completion rates. Subjects eligible for this study were survivors of acute lung injury who had been previously enrolled in a 12-month observational follow-up study evaluating their physical, cognitive and mental health outcomes, with their last study visit completed at a median of 34 months previously. Eligible subjects were contacted to complete a new research survey as part of two randomized trials, initially using a randomized mail-based contact strategy, followed by a randomized telephone-based contact strategy for non-responders to the mail strategy. Both strategies focused on using either a personalized versus a generic approach. In addition, 18 potentially relevant subject-related variables (e.g., demographics, last known physical and mental health status) were evaluated for association with time to survey completion. Of 308 eligible subjects, 67% completed the survey with a median (IQR) of 3 (2, 5) contact attempts required. There was no significant difference in the time to survey completion for either randomized trial of mail- or phone-based contact strategy. Among all subject-related variables, age ≤40 years and minority race were independently associated with a longer time to survey completion. We found that age ≤40 years and minority race were associated with a longer time to survey completion, but personalized versus generic approaches to mail- and telephone-based contact strategies had no significant effect. Repeating both mail and telephone contact attempts was important for increasing survey completion rate. NCT00719446.

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

PubMed Central

2013-01-01

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

The Hi Five study: design of a school-based randomized trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark.

PubMed

Johansen, Anette; Denbæk, Anne Maj; Bonnesen, Camilla Thørring; Due, Pernille

2015-03-01

Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children. Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses. However, most of these studies include small populations and almost none of them are conducted as randomized controlled trials. The overall aim of the Hi Five study was to develop, implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20% compared to control schools. This paper describes the development and the evaluation design of Hi Five. The Hi Five study was designed as a tree-armed cluster-randomized controlled trial. A national random sample of schools (n = 44) was randomized to one of two intervention groups (n = 29) or to a control group with no intervention (n = 15). A total of 8,438 six to fifteen-year-old school children were enrolled in the study. The Hi Five intervention consisted of three components: 1) a curriculum component 2) mandatory daily hand washing before lunch 3) extra cleaning of school toilets during the school day. Baseline data was collected from December 2011 to April 2012. The intervention period was August 2012 to June 2013. The follow-up data was collected from December 2012 to April 2013. The Hi Five study fills a gap in international research. This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum. No previous studies have involved supplementary cleaning at the school toilets as an intervention component. The study will have the added value of providing new knowledge about usability of short message service (SMS, text message) for collecting data on infectious illness and absenteeism in large study populations. Current Controlled Trials ISRCTN19287682 , 21 December 2012.

Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial.

PubMed

Tannenbaum, Cara; Martin, Philippe; Tamblyn, Robyn; Benedetti, Andrea; Ahmed, Sara

2014-06-01

The American Board of Internal Medicine Foundation Choosing Wisely Campaign recommends against the use of benzodiazepine drugs for adults 65 years and older. The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown. To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults. Cluster randomized trial (EMPOWER [Eliminating Medications Through Patient Ownership of End Results] study [2010-2012, 6-month follow-up]). Community pharmacies were randomly allocated to the intervention or control arm in nonstratified, blocked groups of 4. Participants (303 long-term users of benzodiazepine medication aged 65-95 years, recruited from 30 community pharmacies) were screened and enrolled prior to randomization: 15 pharmacies randomized to the educational intervention included 148 participants and 15 pharmacies randomized to the "wait list" control included 155 participants. Participants, physicians, pharmacists, and evaluators were blinded to outcome assessment. The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol. The control arm received usual care. Benzodiazepine therapy discontinuation at 6 months after randomization, ascertained by pharmacy medication renewal profiles. A total of 261 participants (86%) completed the 6-month follow-up. Of the recipients in the intervention group, 62% initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist. At 6 months, 27% of the intervention group had discontinued benzodiazepine use compared with 5% of the control group (risk difference, 23% [95% CI, 14%-32%]; intracluster correlation, 0.008; number needed to treat, 4). Dose reduction occurred in an additional 11% (95% CI, 6%-16%). In multivariate subanalyses, age greater than 80 years, sex, duration of use, indication for use, dose, previous attempt to taper, and concomitant polypharmacy (10 drugs or more per day) did not have a significant interaction effect with benzodiazepine therapy discontinuation. Direct-to-consumer education effectively elicits shared decision making around the overuse of medications that increase the risk of harm in older adults. clinicaltrials.gov Identifier: NCT01148186.

Internet-Delivered Exposure Therapy for Fibromyalgia: A Randomized Controlled Trial.

PubMed

Hedman-Lagerlöf, Maria; Hedman-Lagerlöf, Erik; Axelsson, Erland; Ljótsson, Brjánn; Engelbrektsson, Johanna; Hultkrantz, Sofia; Lundbäck, Karolina; Björkander, Daniel; Wicksell, Rikard K; Flink, Ida; Andersson, Erik

2018-06-01

Fibromyalgia (FM) is a common and disabling chronic pain disorder, for which existing pharmacological and psychological treatments have yet yielded insufficient effects. Previous literature has shown that exposure therapy may be an effective treatment for chronic pain. This study constitutes the first randomized controlled trial evaluating exposure therapy for FM. A total of 140 participants with diagnosed FM were randomized to a 10-week Internet-delivered exposure treatment (iExp; n=70) or a waitlist control condition (WLC; n=70). Primary outcome measure were FM symptoms and impact, and secondary outcome measures were fatigue, disability, quality of life, pain-related distress and avoidance behaviors, insomnia, depression, and anxiety. Data retention was high (100% data completion at posttreatment for primary outcome, 96% at 6-month follow-up and 94% at 12-month follow-up). Results showed that participants in the iExp group made large and superior improvements compared with WLC on FM symptoms and impact (B, -1.93; z, -10.14; P<0.001, between-group Cohen d=0.90), as well as all secondary outcomes (between-group Cohen d ranging from 0.44 to 1.38) with sustained results. We conclude that iExp seems to be an efficacious treatment for FM compared with no treatment, and the results also highlight the potential increase of accessibility by using the Internet format to deliver psychological treatments for these patients. Future trials with active control conditions are warranted.

Injuries in Sedentary Individuals Enrolled in a 12-Month, Randomized, Controlled, Exercise Trial

PubMed Central

Campbell, Kristin L.; Foster-Schubert, Karen; Xiao, Liren; Cadmus Bertram, Lisa A.; Duggan, Catherine; Irwin, Melinda; McTiernan, Anne

2014-01-01

Background The risk of musculoskeletal injury with the introduction of moderate-to-vigorous exercise in sedentary adults is not well established. The purpose of this report is to examine the effect of a 12-month exercise intervention on musculoskeletal injury and bodily pain in predominately overweight, sedentary, men (n=102) and women (n=100), aged 40–75 years. Methods Participants were randomized to a moderate-to-vigorous aerobic exercise intervention (EX) (6 d/wk, 60 min/d, 60–85% max. heart rate) or usual lifestyle control (CON). Participants completed a self-report of musculoskeletal injury and body pain at baseline and 12-months. Results The number of individuals reporting an injury (CON; 27% vs. EX; 28%, p= .95) did not differ by group. The most commonly injured site was lower leg/ankle/foot. The most common causes of injury were sports/physical activity, home maintenance or “other”. In the control group, bodily pain increased over the 12 months compared to the exercise group (CON −7.9, EX −1.4, p=.05). Baseline demographics and volume of exercise were not associated with injury risk. Conclusions Previously sedentary men and women randomized to a 12-month aerobic exercise intervention with a goal of 360 min/wk reported the same number of injuries as those in the control group and less bodily pain. PMID:22368219

Effects of Video Game Training on Behavioral and Electrophysiological Measures of Attention and Memory: Protocol for a Randomized Controlled Trial

PubMed Central

Mayas, Julia; Ruiz-Marquez, Eloisa; Prieto, Antonio; Toril, Pilar; Ponce de Leon, Laura; de Ceballos, Maria L; Reales Avilés, José Manuel

2017-01-01

Background Neuroplasticity-based approaches seem to offer promising ways of maintaining cognitive health in older adults and postponing the onset of cognitive decline symptoms. Although previous research suggests that training can produce transfer effects, this study was designed to overcome some limitations of previous studies by incorporating an active control group and the assessment of training expectations. Objective The main objectives of this study are (1) to evaluate the effects of a randomized computer-based intervention consisting of training older adults with nonaction video games on brain and cognitive functions that decline with age, including attention and spatial working memory, using behavioral measures and electrophysiological recordings (event-related potentials [ERPs]) just after training and after a 6-month no-contact period; (2) to explore whether motivation, engagement, or expectations might account for possible training-related improvements; and (3) to examine whether inflammatory mechanisms assessed with noninvasive measurement of C-reactive protein in saliva impair cognitive training-induced effects. A better understanding of these mechanisms could elucidate pathways that could be targeted in the future by either behavioral or neuropsychological interventions. Methods A single-blinded randomized controlled trial with an experimental group and an active control group, pretest, posttest, and 6-month follow-up repeated measures design is used in this study. A total of 75 cognitively healthy older adults were randomly distributed into experimental and active control groups. Participants in the experimental group received 16 1-hour training sessions with cognitive nonaction video games selected from Lumosity, a commercial brain training package. The active control group received the same number of training sessions with The Sims and SimCity, a simulation strategy game. Results We have recruited participants, have conducted the training protocol and pretest assessments, and are currently conducting posttest evaluations. The study will conclude in the first semester of 2017. Data analysis will take place during 2017. The primary outcome is transfer of benefit from training to attention and working memory functions and the neural mechanisms underlying possible cognitive improvements. Conclusions We expect that mental stimulation with video games will improve attention and memory both at the behavioral level and in ERP components promoting brain and mental health and extending independence among elderly people by avoiding the negative personal and economic consequences of long-term care. Trial Registration Clinicaltrials.gov NCT02796508; https://clinicaltrials.gov/ct2/show/NCT02796508 (archived by WebCite at http://www.webcitation.org/6nFeKeFNB) PMID:28119279

Evidence-Based Medicine in Aesthetic Surgery: The Significance of Level to Aesthetic Surgery.

PubMed

Rohrich, Rod J; Cho, Min-Jeong

2017-05-01

Since its popularization in the 1980s, evidence-based medicine has become the cornerstone of American health care. Many specialties rapidly adapted to the paradigm shift of health care by delivering treatment using the evidence-based guidelines. However, the field of plastic surgery has been slow to implement evidence-based medicine compared with the other specialties because of the challenges of performing randomized controlled trials, such as funding, variability in surgical skills, and difficulty with standardization of techniques. To date, aesthetic surgery has been at the forefront of evidence-based medicine in plastic surgery by having the most randomized controlled trials. Nevertheless, a detailed analysis of these studies has not been previously performed. In this article, the level I and II articles of aesthetic surgery are discussed to increase awareness of high-quality evidence-based medicine in aesthetic surgery.

Feasibility of dialectical behavior therapy with suicidal and self-harming adolescents with multi-problems: training, adherence, and retention.

PubMed

Tørmoen, A J; Grøholt, B; Haga, E; Brager-Larsen, A; Miller, A; Walby, F; Stanley, B; Mehlum, L

2014-01-01

We evaluated the feasibility of DBT training, adherence, and retention preparing for a randomized controlled trial of Dialectical Behavior Therapy (DBT) adapted for Norwegian adolescents engaging in self-harming behavior and diagnosed with features of borderline personality disorder. Therapists were intensively trained and evaluated for adherence. Adherence scores, treatment retention, and present and previous self-harm were assessed. Twenty-seven patients were included (mean age 15.7 years), all of them with recent self-harming behaviors and at least 3 features of Borderline Personality Disorder. Therapists were adherent and 21 (78%) patients completed the whole treatment. Three subjects reported self-harm at the end of treatment, and urges to self-harm decreased. At follow up, 7 of 10 subjects reported no self-harm. DBT was found to be well accepted and feasible. Randomized controlled trials are required to test the effectiveness of DBT for adolescents.

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

PubMed

Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

2015-10-07

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial.

PubMed

Ajimsha, M S; Binsu, D; Chithra, S

2014-06-01

Previous studies have reported that stretching of the calf musculature and the plantar fascia are effective management strategies for plantar heel pain (PHP). However, it is unclear whether myofascial release (MFR) can improve the outcomes in this population. To investigate whether myofascial release (MFR) reduces the pain and functional disability associated with plantar heel pain (PHP) in comparison with a control group receiving sham ultrasound therapy (SUST). Randomized, controlled, double blinded trial. Nonprofit research foundation clinic in India. Sixty-six patients, 17 men and 49 women with a clinical diagnosis of PHP were randomly assigned into MFR or a control group and given 12 sessions of treatment per client over 4 weeks. The Foot Function Index (FFI) scale was used to assess pain severity and functional disability. The primary outcome measure was the difference in FFI scale scores between week 1 (pretest score), week 4 (posttest score), and follow-up at week 12 after randomization. Additionally, pressure pain thresholds (PPT) were assessed over the affected gastrocnemii and soleus muscles, and over the calcaneus, by an assessor blinded to the treatment allocation. The simple main effects analysis showed that the MFR group performed better than the control group in weeks 4 and 12 (P<0.001). Patients in the MFR and control groups reported a 72.4% and 7.4% reduction, respectively, in their pain and functional disability in week 4 compared with that in week 1, which persisted as 60.6% in the follow-up at week 12 in the MFR group compared to the baseline. The mixed ANOVA also revealed significant group-by-time interactions for changes in PPT over the gastrocnemii and soleus muscles, and the calcaneus (P<0.05). This study provides evidence that MFR is more effective than a control intervention for PHP. Copyright © 2014 Elsevier Ltd. All rights reserved.

Dendritic growth model of multilevel marketing

NASA Astrophysics Data System (ADS)

Pang, James Christopher S.; Monterola, Christopher P.

2017-02-01

Biologically inspired dendritic network growth is utilized to model the evolving connections of a multilevel marketing (MLM) enterprise. Starting from agents at random spatial locations, a network is formed by minimizing a distance cost function controlled by a parameter, termed the balancing factor bf, that weighs the wiring and the path length costs of connection. The paradigm is compared to an actual MLM membership data and is shown to be successful in statistically capturing the membership distribution, better than the previously reported agent based preferential attachment or analytic branching process models. Moreover, it recovers the known empirical statistics of previously studied MLM, specifically: (i) a membership distribution characterized by the existence of peak levels indicating limited growth, and (ii) an income distribution obeying the 80 - 20 Pareto principle. Extensive types of income distributions from uniform to Pareto to a "winner-take-all" kind are also modeled by varying bf. Finally, the robustness of our dendritic growth paradigm to random agent removals is explored and its implications to MLM income distributions are discussed.

Erlotinib in African Americans with Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Study with Genetic and Pharmacokinetic Analysis

PubMed Central

Phelps, Mitch A.; Stinchcombe, Thomas E.; Blachly, James S.; Zhao, Weiqiang; Schaaf, Larry J.; Starrett, Sherri L.; Wei, Lai; Poi, Ming; Wang, Danxin; Papp, Audrey; Aimiuwu, Josephine; Gao, Yue; Li, Junan; Otterson, Gregory A.; Hicks, William J.; Socinski, Mark A.; Villalona-Calero, Miguel A.

2014-01-01

Prospective studies focusing on EGFR inhibitors in African Americans with NSCLC have not been previously performed. In this phase II randomized study, 55 African Americans with NSCLC received erlotinib 150mg/day or a body weight adjusted dose with subsequent escalations to the maximum allowable, 200mg/day, to achieve rash. Erlotinib and OSI-420 exposures were lower compared to previous reports, consistent with CYP3A pharmacogenetics implying higher metabolic activity. Tumor genetics revealed only two EGFR mutations, EGFR amplification in 17/47 samples, 8 KRAS mutations and 5 EML4-ALK translocations. Although absence of rash was associated with shorter time to progression (TTP), disease control rate, TTP, and 1-year survival were not different between the two dose groups, indicating the dose-to-rash strategy failed to increase clinical benefit. Observed low incidence of toxicity and low erlotinib exposure suggest standardized and maximum allowable dosing may be suboptimal in African Americans. PMID:24781527

Computer-delivered screening and brief intervention (e-SBI) for postpartum drug use: a randomized trial.

PubMed

Ondersma, Steven J; Svikis, Dace S; Thacker, Leroy R; Beatty, Jessica R; Lockhart, Nancy

2014-01-01

Electronic screening and brief intervention (e-SBI) approaches for substance use have shown early promise. This trial was designed to replicate previous findings from a single 20-minute e-SBI for drug use among postpartum women. A total of 143 postpartum, primarily low-income African-American women meeting criteria for drug use, were randomly assigned to either a tailored e-SBI or a time-matched control condition. Blinded follow-up evaluation 3- and 6-months following childbirth revealed strong effects for confirmed illicit drug use abstinence at the 3-month observation (OR=3.3, p=.01), as did hair analysis at 6months (OR=4.8, p=.018). Additional primary outcomes suggested small to moderate effect sizes in favor of the e-SBI, but did not reach significance. This result replicates previous findings but fails to show durable effects. Assessment reactivity, e-SBI design, and possible extension of e-SBI via tailored messaging all merit careful consideration. © 2013 Elsevier Inc. All rights reserved.

Randomized, Controlled Trial of Fractional Carbon Dioxide Laser Resurfacing Followed by Ultrashort Incubation Aminolevulinic Acid Blue Light Photodynamic Therapy for Actinic Keratosis.

PubMed

Alexiades, Macrene

2017-08-01

Aminolevulinic acid (ALA) photodynamic therapy (PDT) is an established treatment option for actinic keratosis (AK), and recently fractional carbon dioxide (CO2) laser was shown to improve outcomes; but studies of short incubation photosensitizer are lacking. Assess the efficacy of short incubation ALA followed by blue light PDT with and without previous fractional CO2 treatment for the treatment of AK. Randomized, paired split-design, controlled trial of fractional CO2 followed by ultrashort 15-minute versus 30-minute incubation ALA and blue light PDT for the treatment of AK on the face. The complete clearance rates (CRs) at 8 weeks after ALA PDT with and without FxCO2 at 30- and 15-minute ALA incubation times were 89.78% (+FxCO2) versus 71.20% CR (-FxCO2) at 30', and 86.38% (+FxCO2) versus 69.23% (-FxCO2) at 15' ALA incubation. All lesion improvements were statistically significant. This randomized, comparative paired group controlled clinical study demonstrates that ultrashort 15- and 30-minute incubation ALA PDTs are of limited efficacy for the treatment of AK. Pretreatment with fractional ablative resurfacing yields statistically significant greater AK clearance with ALA-PDT at ultrashort ALA incubations followed by blue light.

Balance--a pragmatic randomized controlled trial of an online intensive self-help alcohol intervention.

PubMed

Brendryen, Håvar; Lund, Ingunn Olea; Johansen, Ayna Beate; Riksheim, Marianne; Nesvåg, Sverre; Duckert, Fanny

2014-02-01

To compare a brief versus a brief plus intensive self-help version of 'Balance', a fully automated online alcohol intervention, on self-reported alcohol consumption. A pragmatic randomized controlled trial. Participants in both conditions received an online single session screening procedure including personalized normative feedback. The control group also received an online booklet about the effects of alcohol. The treatment group received the online multi-session follow-up program, Balance. Online study in Norway. At-risk drinkers were recruited by internet advertisements and assigned randomly to one of the two conditions (n = 244). The primary outcome was self-reported alcohol consumption the previous week measured 6 months after screening. Regression analysis, using baseline carried forward imputation (intent-to-treat), with baseline variables as covariates, showed that intervention significantly affected alcohol consumption at 6 months (B = 2.96; 95% confidence interval = 0.02-5.90; P = 0.049). Participants in the intensive self-help group drank an average of three fewer standard alcohol units compared with participants in the brief self-help group. The online Balance intervention, added to a brief online screening intervention, may aid reduction in alcohol consumption compared with the screening intervention and an educational booklet. © 2013 Society for the Study of Addiction.

Learning From Past Failures of Oral Insulin Trials.

PubMed

Michels, Aaron W; Gottlieb, Peter A

2018-07-01

Very recently one of the largest type 1 diabetes prevention trials using daily administration of oral insulin or placebo was completed. After 9 years of study enrollment and follow-up, the randomized controlled trial failed to delay the onset of clinical type 1 diabetes, which was the primary end point. The unfortunate outcome follows the previous large-scale trial, the Diabetes Prevention Trial-Type 1 (DPT-1), which again failed to delay diabetes onset with oral insulin or low-dose subcutaneous insulin injections in a randomized controlled trial with relatives at risk for type 1 diabetes. These sobering results raise the important question, "Where does the type 1 diabetes prevention field move next?" In this Perspective, we advocate for a paradigm shift in which smaller mechanistic trials are conducted to define immune mechanisms and potentially identify treatment responders. The stage is set for these interventions in individuals at risk for type 1 diabetes as Type 1 Diabetes TrialNet has identified thousands of relatives with islet autoantibodies and general population screening for type 1 diabetes risk is under way. Mechanistic trials will allow for better trial design and patient selection based upon molecular markers prior to large randomized controlled trials, moving toward a personalized medicine approach for the prevention of type 1 diabetes. © 2018 by the American Diabetes Association.

Random fiber laser based on artificially controlled backscattering fibers.

PubMed

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

2018-01-10

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

More randomized and resilient in the topological properties of functional brain networks in patients with major depressive disorder.

PubMed

Li, Huaizhou; Zhou, Haiyan; Yang, Yang; Wang, Haiyuan; Zhong, Ning

2017-10-01

Previous studies have reported the enhanced randomization of functional brain networks in patients with major depressive disorder (MDD). However, little is known about the changes of key nodal attributes for randomization, the resilience of network, and the clinical significance of the alterations. In this study, we collected the resting-state functional MRI data from 19 MDD patients and 19 healthy control (HC) individuals. Graph theory analysis showed that decreases were found in the small-worldness, clustering coefficient, local efficiency, and characteristic path length (i.e., increase of global efficiency) in the network of MDD group compared with HC group, which was consistent with previous findings and suggested the development toward randomization in the brain network in MDD. In addition, the greater resilience under the targeted attacks was also found in the network of patients with MDD. Furthermore, the abnormal nodal properties were found, including clustering coefficients and nodal efficiencies in the left orbital superior frontal gyrus, bilateral insula, left amygdala, right supramarginal gyrus, left putamen, left posterior cingulate cortex, left angular gyrus. Meanwhile, the correlation analysis showed that most of these abnormal areas were associated with the clinical status. The observed increased randomization and resilience in MDD might be related to the abnormal hub nodes in the brain networks, which were attacked by the disease pathology. Our findings provide new evidence to indicate that the weakening of specialized regions and the enhancement of whole brain integrity could be the potential endophenotype of the depressive pathology. Copyright © 2017 Elsevier Ltd. All rights reserved.

An Ecological Momentary Intervention to Reduce Alcohol Consumption in Young Adults Delivered During Drinking Events: Protocol for a Pilot Randomized Controlled Trial.

PubMed

Wright, Cassandra Jc; Dietze, Paul M; Agius, Paul A; Kuntsche, Emmanuel; Room, Robin; Livingston, Michael; Hellard, Margaret; Lim, Megan Sc

2017-05-25

Risky drinking is a significant public health issue in young Australian adults. Brief interventions are one of few effective methods of reducing risky drinking but are time and cost intensive; innovative methods of delivery are therefore of interest. Mobile phones offer new opportunities to collect data and intervene during risky drinking events. Mobile phones have successfully been used for delivery of alcohol-related brief interventions and data collection but not in combination with or during drinking events. This pilot study will investigate the efficacy of an ecological momentary intervention (EMI), with combined ecological momentary assessment (EMA) and brief intervention delivered by mobile phones to young adults during risky drinking events. We will use a 3-armed randomized controlled trial to investigate the efficacy of the intervention for reducing peak single occasion drinking. Our sample is recruited from an observational cohort study of young, risky drinkers. Participants will be randomized into 1 of 3 intervention arms. On 6 nights across a 12-week study period, EMI and EMA groups will complete hourly EMA surveys on their mobile phone. EMI participants will receive tailored feedback short message service (SMS) texts corresponding to their EMA survey responses. The EMI participants will not receive feedback SMS. A third group will have no contact (no-contact control). All groups will then be contacted for a follow-up interview within 4 weeks of the 12-week study period ending. The primary outcome is mean reduction in standard drinks consumed during their most recent heavy drinking occasion as measured at follow-up. Secondary outcomes include alcohol consumption over the previous 6 months, experiences of alcohol-related harms, attitudes toward drinking and drunkenness, hazardous drinking and use of tobacco and illicit drugs. A random effects mixed modelling approach using maximum likelihood estimation will be used to provide estimates of differences in mean drinking levels between those receiving the intervention and control participants. This study is novel in that, unlike previous work, it will intervene repeatedly during single occasion drinking events. Further, it extends previous research in this area, which has applied limited tailoring of message content for SMS-based brief interventions. The findings of this study will contribute to the growing body of evidence to inform the use of mobile health interventions for reducing alcohol consumption and harms. Australian New Zealand Clinical Trials ACTRN12616001323415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=369534 (Archived by WebCite at http://www.webcitation.org/ 6qDqBZV9b). ©Cassandra JC Wright, Paul M Dietze, Paul A Agius, Emmanuel Kuntsche, Robin Room, Michael Livingston, Margaret Hellard, Megan SC Lim. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.05.2017.

An Ecological Momentary Intervention to Reduce Alcohol Consumption in Young Adults Delivered During Drinking Events: Protocol for a Pilot Randomized Controlled Trial

PubMed Central

Dietze, Paul M; Agius, Paul A; Kuntsche, Emmanuel; Room, Robin; Livingston, Michael; Hellard, Margaret; Lim, Megan SC

2017-01-01

Background Risky drinking is a significant public health issue in young Australian adults. Brief interventions are one of few effective methods of reducing risky drinking but are time and cost intensive; innovative methods of delivery are therefore of interest. Mobile phones offer new opportunities to collect data and intervene during risky drinking events. Mobile phones have successfully been used for delivery of alcohol-related brief interventions and data collection but not in combination with or during drinking events. Objective This pilot study will investigate the efficacy of an ecological momentary intervention (EMI), with combined ecological momentary assessment (EMA) and brief intervention delivered by mobile phones to young adults during risky drinking events. Methods We will use a 3-armed randomized controlled trial to investigate the efficacy of the intervention for reducing peak single occasion drinking. Our sample is recruited from an observational cohort study of young, risky drinkers. Participants will be randomized into 1 of 3 intervention arms. On 6 nights across a 12-week study period, EMI and EMA groups will complete hourly EMA surveys on their mobile phone. EMI participants will receive tailored feedback short message service (SMS) texts corresponding to their EMA survey responses. The EMI participants will not receive feedback SMS. A third group will have no contact (no-contact control). All groups will then be contacted for a follow-up interview within 4 weeks of the 12-week study period ending. Results The primary outcome is mean reduction in standard drinks consumed during their most recent heavy drinking occasion as measured at follow-up. Secondary outcomes include alcohol consumption over the previous 6 months, experiences of alcohol-related harms, attitudes toward drinking and drunkenness, hazardous drinking and use of tobacco and illicit drugs. A random effects mixed modelling approach using maximum likelihood estimation will be used to provide estimates of differences in mean drinking levels between those receiving the intervention and control participants. Conclusions This study is novel in that, unlike previous work, it will intervene repeatedly during single occasion drinking events. Further, it extends previous research in this area, which has applied limited tailoring of message content for SMS-based brief interventions. The findings of this study will contribute to the growing body of evidence to inform the use of mobile health interventions for reducing alcohol consumption and harms. Trial Registration Australian New Zealand Clinical Trials ACTRN12616001323415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=369534 (Archived by WebCite at http://www.webcitation.org/ 6qDqBZV9b) PMID:28546136

Vaginal delivery after previous caesarean section: is X-ray pelvimetry necessary?

PubMed

Thubisi, M; Ebrahim, A; Moodley, J; Shweni, P M

1993-05-01

To determine whether antepartum X-ray pelvimetry (XRP) reliably identified women suitable for a trial labour or repeat elective caesarean section after one previous section. A prospective controlled trial in which women were randomly allocated to either an antepartum XRP group who had XRP at 36 weeks gestation to determine mode of delivery, or a control group who had a trial labour without antepartum XRP. Following delivery, all controls had postpartum XRP. Department of Obstetrics and Gynaecology, King Edward VIII Hospital, Durban, South Africa. Three hundred-six women with a history of one previous caesarean section. Mode of delivery, birthweight and maternal and perinatal mortality and morbidity in the two groups. In the antepartum XRP group, 23 of 144 (16%) of women delivered vaginally compared with 60 of 144 (42%) controls (P < 0.0001). Of the 84 women with adequate antepartum XRP only 23 (27.7%) delivered vaginally. In the control group, 33 of 60 (55%) women who had vaginal deliveries had inadequate postpartum XRP and would have had a caesarean section if this information was known in the antepartum period; 62 of 84 (74%) caesarean sections in the control group had adequate postpartum XRP. Birthweight of the infants was similar in the two groups. There were no maternal or perinatal deaths. Maternal morbidity was similar in the two groups. Neonatal morbidity was minimal. Antepartum XRP is not necessary prior to a trial labour in women with one previous caesarean section. It increases the caesarean section rate and is a poor predictor of the outcome of labour.

Reaching out, inviting back: using Interactive voice response (IVR) technology to recycle relapsed smokers back to Quitline treatment – a randomized controlled trial

PubMed Central

2012-01-01

Background Tobacco dependence is a chronic, relapsing condition that typically requires multiple quit attempts and extended treatment. When offered the opportunity, relapsed smokers are interested in recycling back into treatment for a new, assisted quit attempt. This manuscript presents the results of a randomized controlled trial testing the efficacy of interactive voice response (IVR) in recycling low income smokers who had previously used quitline (QL) support back to QL support for a new quit attempt. Methods A sample of 2985 previous QL callers were randomized to either receive IVR screening for current smoking (control group) or IVR screening plus an IVR intervention. The IVR intervention consists of automated questions to identify and address barriers to re-cycling in QL support, followed by an offer to be transferred to the QL and reinitiate treatment. Re-enrollment in QL services for both groups was documented. Results The IVR system successfully reached 715 (23.9%) former QL participants. Of those, 27% (194/715) reported to the IVR system that they had quit smoking and were therefore excluded from the study and analysis. The trial’s final sample was composed of 521 current smokers. The re-enrollment rate was 3.3% for the control group and 28.2% for the intervention group (p < .001). Logistic regression results indicated an 11.2 times higher odds for re-enrollment of the intervention group than the control group (p < .001). Results did not vary by gender, race, ethnicity, or level of education, however recycled smokers were older (Mean =45.2; SD = 11.7) than smokers who declined a new treatment cycle (Mean = 41.8; SD = 13.2); (p = 0.013). The main barriers reported for not engaging in a new treatment cycle were low self-efficacy and lack of interest in quitting. After delivering IVR messages targeting these reported barriers, 32% of the smokers reporting low self-efficacy and 4.8% of those reporting lack of interest in quitting re-engaged in a new QL treatment cycle. Conclusion Proactive IVR outreach is a promising tool to engage low income, relapsed smokers back into a new cycle of treatment. Integration of IVR intervention for recycling smokers with previous QL treatment has the potential to decrease tobacco-related disparities. Trial registration ClinicalTrials.gov Identifier: NCT01260597 PMID:22768793

Internet-based self-management plus education compared with usual care in asthma: a randomized trial.

PubMed

van der Meer, Victor; Bakker, Moira J; van den Hout, Wilbert B; Rabe, Klaus F; Sterk, Peter J; Kievit, Job; Assendelft, Willem J J; Sont, Jacob K

2009-07-21

The Internet may support patient self-management of chronic conditions, such as asthma. To evaluate the effectiveness of Internet-based asthma self-management. Randomized, controlled trial. 37 general practices and 1 academic outpatient department in the Netherlands. 200 adults with asthma who were treated with inhaled corticosteroids for 3 months or more during the previous year and had access to the Internet. Asthma-related quality of life at 12 months (minimal clinically significant difference of 0.5 on the 7-point scale), asthma control, symptom-free days, lung function, and exacerbations. Participants were randomly assigned by using a computer-generated permuted block scheme to Internet-based self-management (n = 101) or usual care (n = 99). The Internet-based self-management program included weekly asthma control monitoring and treatment advice, online and group education, and remote Web communications. Asthma-related quality of life improved by 0.56 and 0.18 points in the Internet and usual care groups, respectively (adjusted between-group difference, 0.38 [95% CI, 0.20 to 0.56]). An improvement of 0.5 point or more occurred in 54% and 27% of Internet and usual care patients, respectively (adjusted relative risk, 2.00 [CI, 1.38 to 3.04]). Asthma control improved more in the Internet group than in the usual care group (adjusted difference, -0.47 [CI, -0.64 to -0.30]). At 12 months, 63% of Internet patients and 52% of usual care patients reported symptom-free days in the previous 2 weeks (adjusted absolute difference, 10.9% [CI, 0.05% to 21.3%]). Prebronchodilator FEV1 changed with 0.24 L and -0.01 L for Internet and usual care patients, respectively (adjusted difference, 0.25 L [CI, 0.03 to 0.46 L]). Exacerbations did not differ between groups. The study was unblinded and lasted only 12 months. Internet-based self-management resulted in improvements in asthma control and lung function but did not reduce exacerbations, and improvement in asthma-related quality of life was slightly less than clinically significant. Netherlands Organization for Health Research and Development, ZonMw, and Netherlands Asthma Foundation.

The role of patent ductus arteriosus ligation in bronchopulmonary dysplasia: reexamining a randomized controlled trial.

PubMed

Clyman, Ronald; Cassady, George; Kirklin, James K; Collins, Monica; Philips, Joseph B

2009-06-01

To reexamine data from a randomized controlled trial of prophylactic ductus ligation to determine whether ligation contributes directly to the development of bronchopulmonary dysplasia (BPD) in extremely low birth weight infants. The control group underwent ligation only if they had development of a symptomatic patent ductus arteriosus (PDA). The Prophylactic Ligation group underwent ligation within 24 hours of birth regardless of the presence or absence of symptoms of a PDA. We hypothesized that the incidence of BPD would be higher in the prophylactic ligation group because more ligations were performed than in the control group. Prophylactic ligation significantly increased the incidence of BPD (defined as a supplemental oxygen requirement at 36 weeks postmenstrual age) and the incidence of mechanical ventilation at 36 weeks. The groups were statistically similar in gestation, sex, race, fluid administration, intraventricular hemorrhage, pulmonary air leaks, and survival to 36 weeks. The lower incidence of BPD in the control group occurred despite the fact that the incidence of necrotizing enterocolitis (a known risk factor for BPD) was significantly elevated in the control group. Only infants who had previously undergone a PDA ligation had development of BPD in the control group. Prophylactic ligation, while eliminating the PDA, increases the risk for BPD.

Failing to Prepare Is Preparing to Fail: A Single-Blinded, Randomized Controlled Trial to Determine the Impact of a Preoperative Instructional Video on the Ability of Residents to Perform Laparoscopic Right Colectomy.

PubMed

Crawshaw, Benjamin P; Steele, Scott R; Lee, Edward C; Delaney, Conor P; Mustain, W Conan; Russ, Andrew J; Shanmugan, Skandan; Champagne, Bradley J

2016-01-01

Laparoscopic colorectal resection is an index case for advanced skills training, yet many residents struggle to reach proficiency by graduation. Current methods to reduce the learning curve for residents remain expensive, time consuming, and poorly validated. The purpose of this study was to assess the impact of the addition of a preprocedural instructional video to improve the ability of a general surgery resident to perform laparoscopic right colectomy when compared with standard preparation. This was a single-blinded, randomized control study. Four university-affiliated teaching hospitals were included in the study. General surgery residents in postgraduation years 2 through 5 participated. Residents were randomly assigned to preparation with a narrated instructional video versus standard preparation. Resident performance, scored by a previously validated global assessment scale, was measured. Fifty-four residents were included. Half (n = 27) were randomly assigned to view the training video and half (n = 27) to standard preparation. There were no differences between groups in terms of training level or previous operative experience or in patient demographics (all p > 0.05). Groups were similar in the percentage of the case completed by residents (p = 0.39) and operative time (p = 0.74). Residents in the video group scored significantly higher in total score (mean: 46.8 vs 42.3; p = 0.002), as well as subsections directly measuring laparoscopic skill (vascular control mean: 11.3 vs 9.7, p < 0.001; mobilization mean: 7.6 vs. 7.0, p = 0.03) and overall performance score (mean: 4.0 vs 3.1; p < 0.001). Statistical significance persisted across training levels. There is potential for Hawthorne effect, and the study is underpowered at the individual postgraduate year level. The simple addition of a brief, narrated preprocedural video to general surgery resident case preparation significantly increased trainee ability to successfully perform a laparoscopic right colectomy. In an era of shortened hours and less exposure to cases, incorporating a brief but effective instructional video before surgery may improve the learning curve of trainees and ultimately improve safety.

Unexpected perturbations training improves balance control and voluntary stepping times in older adults - a double blind randomized control trial.

PubMed

Kurz, Ilan; Gimmon, Yoav; Shapiro, Amir; Debi, Ronen; Snir, Yoram; Melzer, Itshak

2016-03-04

Falls are common among elderly, most of them occur while slipping or tripping during walking. We aimed to explore whether a training program that incorporates unexpected loss of balance during walking able to improve risk factors for falls. In a double-blind randomized controlled trial 53 community dwelling older adults (age 80.1±5.6 years), were recruited and randomly allocated to an intervention group (n = 27) or a control group (n = 26). The intervention group received 24 training sessions over 3 months that included unexpected perturbation of balance exercises during treadmill walking. The control group performed treadmill walking with no perturbations. The primary outcome measures were the voluntary step execution times, traditional postural sway parameters and Stabilogram-Diffusion Analysis. The secondary outcome measures were the fall efficacy Scale (FES), self-reported late life function (LLFDI), and Performance-Oriented Mobility Assessment (POMA). Compared to control, participation in intervention program that includes unexpected loss of balance during walking led to faster Voluntary Step Execution Times under single (p = 0.002; effect size [ES] =0.75) and dual task (p = 0.003; [ES] = 0.89) conditions; intervention group subjects showed improvement in Short-term Effective diffusion coefficients in the mediolateral direction of the Stabilogram-Diffusion Analysis under eyes closed conditions (p = 0.012, [ES] = 0.92). Compared to control there were no significant changes in FES, LLFDI, and POMA. An intervention program that includes unexpected loss of balance during walking can improve voluntary stepping times and balance control, both previously reported as risk factors for falls. This however, did not transferred to a change self-reported function and FES. ClinicalTrials.gov NCT01439451 .

Acetyl-L-Carnitine as an Adjunctive Therapy in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A Placebo-Controlled Trial

ERIC Educational Resources Information Center

Abbasi, Seyed-Hesameddin; Heidari, Shahram; Mohammadi, Mohammad-Reza; Tabrizi, Mina; Ghaleiha, Ali; Akhondzadeh, Shahin

2011-01-01

The objective of this study was to test whether a previous observed Acetyl-L-carnitine (ALC) treatment effect could be repeated in an ALC adjunctive therapy treatment trial of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This was a six-week, randomized clinical trial undertaken in an outpatient child and adolescent…

Single-Session Personalized Cognitive Counseling to Change HIV Risk Behavior among HIV-Negative Men Who Have Sex with Men: A Two-Part Case Study

ERIC Educational Resources Information Center

McPhee, Brian; Skinta, Matthew D.; Paul, Jay; Dilley, James W.

2012-01-01

Two previous randomized controlled clinical trials have shown the effectiveness of a single-session cognitive intervention, personalized cognitive counseling (PCC), in decreasing HIV risk among men who have sex with men (MSM; Dilley et al., 2002; Dilley et al., 2007). PCC is a counseling technique based on social cognitive theory and the stages of…

Randomized Controlled Trial of a Book-Sharing Intervention in a Deprived South African Community: Effects on Carer-Infant Interactions, and Their Relation to Infant Cognitive and Socioemotional Outcome

ERIC Educational Resources Information Center

Murray, Lynne; De Pascalis, Leonardo; Tomlinson, Mark; Vally, Zahir; Dadomo, Harold; MacLachlan, Brenda; Woodward, Charlotte; Cooper, Peter J.

2016-01-01

Background: Consistent with evidence from high-income countries (HICs), we previously showed that, in an informal peri-urban settlement in a low-middle income country, training parents in book sharing with their infants benefitted infant language and attention (Vally, Murray, Tomlinson, & Cooper, [Vally, Z., 2015]). Here, we investigated…

Does Humor Have an Effect on the Performance of College Freshmen in Improving Scores on the Nelson Denny Reading Post Test?

ERIC Educational Resources Information Center

Schiller, Maryann F.

A study was conducted to investigate the effects of humor on the performance of college freshmen on the Nelson Denny Reading Post Test. The subjects, 36 college freshmen from two developmental reading improvement classes, were randomly assigned to experimental A or B or control sample groups. Students had previously taken forms F and C of the test…

The genetic control of phenformin 4-hydroxylation.

PubMed Central

Shah, R R; Evans, D A; Oates, N S; Idle, J R; Smith, R L

1985-01-01

Previously published results of phenformin 4-hydroxylation in 195 unrelated white British volunteers and 87 family members of 27 randomly selected probands have been subjected to genetic analysis. The results clearly show that about 9% of this population has a genetically determined defect in carrying out this oxidation reaction. The character for the defect is inherited in a Mendelian autosomal recessive fashion. The polymorphism shows a substantial degree of dominance. PMID:4078865

What The Oregon Health Study Can Tell Us About Expanding Medicaid

PubMed Central

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

2012-01-01

The recently enacted Patient Protection and Affordable Care Act includes a major expansion of Medicaid to low-income adults in 2014. This paper describes the Oregon Health Study, a randomized controlled trial that will be able to shed some light on the likely effects of such expansions. In 2008, Oregon randomly drew names from a waiting list for its previously closed public insurance program. Our analysis of enrollment into this program found that people who signed up for the waiting list and enrolled in the Oregon Medicaid program were likely to have worse health than those who did not. However, actual enrollment was fairly low, partly because many applicants did not meet eligibility standards. PMID:20679654

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

PubMed

Arrieta, Carlos; Navarro, José; Vicente, Susana

2008-11-01

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

Long-term safety of early consumption of Lactobacillus fermentum CECT5716: A 3-year follow-up of a randomized controlled trial.

PubMed

Maldonado-Lobón, J A; Gil-Campos, M; Maldonado, J; López-Huertas, E; Flores-Rojas, K; Valero, A D; Rodríguez-Benítez, M V; Bañuelos, O; Lara-Villoslada, F; Fonollá, J; Olivares, M

2015-01-01

Lactobacillus fermentum CECT5716 is a probiotic strain originally isolated from human breast milk. Previous clinical studies in infants showed that the early administration of a milk formula containing this probiotic strain was safe and may be useful for the prevention of community-acquired infections. This is a 3-year follow-up study aimed at evaluating the long-term effects produced by the early consumption of an infant formula supplemented with L. fermentum CECT5716 (experimental group, EG) compared with a control formula without the probiotic (control group, CG). The infants included in this follow-up study had previously completed a 5-month randomized double-blind controlled trial (from 1 to 6 months of age), where the safety and tolerance of the probiotic formula was evaluated. The main outcome of the follow-up study was the growth of the children. The secondary outcomes included the incidence of infectious and non-infectious diseases, parameters related with intestinal function and faecal microbiota. At 3 years, the mean values of weight, length and head circumference were similar in children of the EG compared with those of the CG. No differences were observed in the incidence of infectious and non-infectious diseases or disorders related with intestinal function. The pattern of faecal microbiota was also similar between both groups. In conclusion, this 3-year study shows that the early administration of the probiotic of L. fermentum CECT5716 in an infant formula is safe and it does not produce measurable differences in children compared with a control formula. Copyright © 2015 Elsevier Ltd. All rights reserved.

Higher Strength Lanthanum Carbonate Provides Serum Phosphorus Control With a Low Tablet Burden and Is Preferred by Patients and Physicians: A Multicenter Study

PubMed Central

Mehrotra, Rajnish; Martin, Kevin J.; Fishbane, Steven; Sprague, Stuart M.; Zeig, Steven; Anger, Michael

2008-01-01

Background and objectives: Management of hyperphosphatemia, a predictor of mortality in chronic kidney disease, is challenging. Nonadherence to dietary phosphate binders, in part, contributes to uncontrolled serum phosphorus levels. This phase IIIb trial assessed the efficacy of increased dosages (3000 to 4500 mg/d) of reformulated lanthanum carbonate (500-, 750-, and 1000-mg tablets) in nonresponders to dosages of up to 3000 mg/d. Design, setting, participants, & measurements: This 8-wk study with a 4-mo open-label extension enrolled 513 patients who were undergoing maintenance hemodialysis. Patients who achieved serum phosphorus control at week 4 with ≤3000 mg/d lanthanum carbonate entered cohort A; nonresponders were randomly assigned to receive 3000, 3750, or 4500 mg/d (cohort B). The primary outcome measure was the control rate for predialysis serum phosphorus levels at the end of week 8, among patients in cohort B. Results: At the end of week 4, 54% of patients achieved serum phosphorus control at dosages ≤3000 mg/d administered as one tablet per meal. Among patients who entered cohort B, control rates of 25, 38, and 32% for patients who were randomly assigned to 3000, 3750, or 4500 mg/d lanthanum carbonate, respectively, were achieved, with no increase in adverse events. Patients and physicians reported significantly higher levels of satisfaction with reformulated lanthanum carbonate compared with previous phosphate binders, partly because of reduced tablet burden with higher dosage strengths. Physicians and patients also expressed a preference for lanthanum carbonate over previous medication. Conclusions: Reformulated lanthanum carbonate is an effective phosphate binder that may reduce daily tablet burden. PMID:18579668

Less deep vein thrombosis due to transcutaneous fibular nerve stimulation in total knee arthroplasty: a randomized controlled trial.

PubMed

Izumi, Masashi; Ikeuchi, Masahiko; Aso, Koji; Sugimura, Natsuki; Kamimoto, Yuko; Mitani, Tetsuya; Ueta, Tadashi; Sato, Takayuki; Yokoyama, Masataka; Sugiura, Tetsuro; Tani, Toshikazu

2015-11-01

It has been known for years that deep vein thrombi (DVT) start to develop during total joint arthroplasty. Previously, we reported effective prevention of venous stasis by transcutaneous electrical nerve stimulation (TENS). It is hypothesized that TENS might be a thromboprophylactic tool for the limb undergoing surgery. The purpose of this study is to clarify the clinical efficacy and safety of TENS in patients during total knee arthroplasty (TKA). Ninety patients undergoing primary TKA were involved and randomly allocated to the TENS or control group. In the TENS group, electrical stimulation of the common fibular nerve, which produced a brisk dorsiflexion of the ankle, was performed for the operated leg during surgery. In the control group, no electrical stimulation was applied. Serum D-dimer and soluble fibrin monomer complex (SFMC) levels were measured before surgery, immediately after surgery, and post-operative day (POD) 1. Ultrasonography was performed on POD 1. Immediately after surgery, D-dimer and SFMC levels of each group were significantly lower in the TENS group compared with control (p < 0.05). The incidence of DVT was 11 % (five cases) in the TENS group while 31 % (14 cases) in control (p = 0.02). There were no adverse effects related to TENS. TENS during TKA showed significant effects on preventing DVT. Sustaining muscle pump activation during surgery prevented not only venous stasis, but also hypercoagulability of blood. Intraoperative TENS is a safe and novel strategy against early post-operative thromboembolism, which is difficult to be completed through existing prophylaxis after total joint arthroplasty. Randomized controlled trial, Level I.

Acromegaly treatment in Romania. How close are we to disease control?

PubMed

Niculescu, Dan Alexandru; Baciu, Ionela Florina; Capatina, Cristina; Galoiu, Simona Andreea; Gheorghiu, Monica Livia; Radian, Serban; Trifanescu, Raluca Alexandra; Caragheorgheopol, Andra; Coculescu, Mihail; Poiana, Catalina

2017-01-01

In Romania, no nationwide data for acromegaly treatment and control rate are available. Our objective was to assess the acromegaly control rate in a tertiary referral centre, which covers an important part of Romanian territory and population of patients with acromegaly. We reviewed the records of all 164 patients (49 males and 115 females; median age 55 [47, 63.5] years) with newly or previously diagnosed acromegaly, who have been assessed at least once in our tertiary referral centre between January 1, 2012 and March 31, 2016. This sample represents 13.6% of the total expected 1200 Romanian patients with acromegaly and covers 82.9% of the counties in Romania. Control of acromegaly was defined as a random serum growth hormone (GH) < 1 ng/mL and an age-normalised serum insulin-like growth factor-I (IGF-I) value. The GH and IGF-I values used for calculation of the control rate were those at the last evaluation. The same assays for GH and IGF-I measurement were used in all patients. There were 147 treated and 17 untreated patients. Of the 147 patients assessed after therapy, 137 (93.2%) had pituitary surgery, 116 (78.9%) were on medical treatment at the last evaluation, and 67 (45.5%) had radiotherapy. Seventy-one (48.3%) had a random GH < 1 ng/mL, 54 (36.7%) had a normalised, age-adjusted IGF-I, and 42 (28.6%) had both normal random serum GH and IGF-I. In Romania, acromegaly benefits from the whole spectrum of therapeutic interventions. However, the control rate remains disappointing.

Efficacy of web-based personalized normative feedback: a two-year randomized controlled trial.

PubMed

Neighbors, Clayton; Lewis, Melissa A; Atkins, David C; Jensen, Megan M; Walter, Theresa; Fossos, Nicole; Lee, Christine M; Larimer, Mary E

2010-12-01

Web-based brief alcohol interventions have the potential to reach a large number of individuals at low cost; however, few controlled evaluations have been conducted to date. The present study was designed to evaluate the efficacy of gender-specific versus gender-nonspecific personalized normative feedback (PNF) with single versus biannual administration in a 2-year randomized controlled trial targeting a large sample of heavy-drinking college students. Participants included 818 freshmen (57.6% women; 42% non-Caucasian) who reported 1 or more heavy-drinking episodes in the previous month at baseline. Participants were randomly assigned in a 2 (gender-specific vs. gender-nonspecific PNF) × 2 (single vs. biannual administration of PNF) + 1 (attention control) design. Assessments occurred every 6 months for a 2-year period. Results from hierarchical generalized linear models provided modest effects on weekly drinking and alcohol-related problems but not on heavy episodic drinking. Relative to control, gender-specific biannual PNF was associated with reductions over time in weekly drinking (d = -0.16, 95% CI [-0.02, -0.31]), and this effect was partially mediated by changes in perceived norms. For women, but not men, gender-specific biannual PNF was associated with reductions over time in alcohol-related problems relative to control (d = -0.29, 95% CI [-0.15, -0.58]). Few other effects were evident. The present research provides modest support for the use of biannually administered web-based gender-specific PNF as an alternative to more costly indicated prevention strategies. (c) 2010 APA, all rights reserved.

Evaluation of Tai Chi Yunshou exercises on community-based stroke patients with balance dysfunction: a study protocol of a cluster randomized controlled trial.

PubMed

Tao, Jing; Rao, Ting; Lin, Lili; Liu, Wei; Wu, Zhenkai; Zheng, Guohua; Su, Yusheng; Huang, Jia; Lin, Zhengkun; Wu, Jinsong; Fang, Yunhua; Chen, Lidian

2015-02-25

Balance dysfunction after stroke limits patients' general function and participation in daily life. Previous researches have suggested that Tai Chi exercise could offer a positive improvement in older individuals' balance function and reduce the risk of falls. But convincing evidence for the effectiveness of enhancing balance function after stroke with Tai Chi exercise is still inadequate. Considering the difficulties for stroke patients to complete the whole exercise, the current trial evaluates the benefit of Tai Chi Yunshou exercise for patients with balance dysfunction after stroke through a cluster randomization, parallel-controlled design. A single-blind, cluster-randomized, parallel-controlled trial will be conducted. A total of 10 community health centers (5 per arm) will be selected and randomly allocated into Tai Chi Yunshou exercise group or balance rehabilitation training group. Each community health centers will be asked to enroll 25 eligible patients into the trial. 60 minutes per each session, 1 session per day, 5 times per week and the total training round is 12 weeks. Primary and secondary outcomes will be measured at baseline and 4-weeks, 8-weeks, 12-weeks, 6-week follow-up, 12-week follow-up after randomization. Safety and economic evaluation will also be assessed. This protocol aims to evaluate the effectiveness of Tai Chi Yunshou exercise for the balance function of patients after stroke. If the outcome is positive, this project will provide an appropriate and economic balance rehabilitation technology for community-based stroke patients. Chinese Clinical Trial Registry: ChiCTR-TRC-13003641. Registration date: 22 August, 2013 http://www.chictr.org/usercenter/project/listbycreater.aspx .

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

Management of lumbar zygapophysial (facet) joint pain

PubMed Central

Manchikanti, Laxmaiah; Hirsch, Joshua A; Falco, Frank JE; Boswell, Mark V

2016-01-01

AIM: To investigate the diagnostic validity and therapeutic value of lumbar facet joint interventions in managing chronic low back pain. METHODS: The review process applied systematic evidence-based assessment methodology of controlled trials of diagnostic validity and randomized controlled trials of therapeutic efficacy. Inclusion criteria encompassed all facet joint interventions performed in a controlled fashion. The pain relief of greater than 50% was the outcome measure for diagnostic accuracy assessment of the controlled studies with ability to perform previously painful movements, whereas, for randomized controlled therapeutic efficacy studies, the primary outcome was significant pain relief and the secondary outcome was a positive change in functional status. For the inclusion of the diagnostic controlled studies, all studies must have utilized either placebo controlled facet joint blocks or comparative local anesthetic blocks. In assessing therapeutic interventions, short-term and long-term reliefs were defined as either up to 6 mo or greater than 6 mo of relief. The literature search was extensive utilizing various types of electronic search media including PubMed from 1966 onwards, Cochrane library, National Guideline Clearinghouse, clinicaltrials.gov, along with other sources including previous systematic reviews, non-indexed journals, and abstracts until March 2015. Each manuscript included in the assessment was assessed for methodologic quality or risk of bias assessment utilizing the Quality Appraisal of Reliability Studies checklist for diagnostic interventions, and Cochrane review criteria and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool for therapeutic interventions. Evidence based on the review of the systematic assessment of controlled studies was graded utilizing a modified schema of qualitative evidence with best evidence synthesis, variable from level I to level V. RESULTS: Across all databases, 16 high quality diagnostic accuracy studies were identified. In addition, multiple studies assessed the influence of multiple factors on diagnostic validity. In contrast to diagnostic validity studies, therapeutic efficacy trials were limited to a total of 14 randomized controlled trials, assessing the efficacy of intraarticular injections, facet or zygapophysial joint nerve blocks, and radiofrequency neurotomy of the innervation of the facet joints. The evidence for the diagnostic validity of lumbar facet joint nerve blocks with at least 75% pain relief with ability to perform previously painful movements was level I, based on a range of level I to V derived from a best evidence synthesis. For therapeutic interventions, the evidence was variable from level II to III, with level II evidence for lumbar facet joint nerve blocks and radiofrequency neurotomy for long-term improvement (greater than 6 mo), and level III evidence for lumbosacral zygapophysial joint injections for short-term improvement only. CONCLUSION: This review provides significant evidence for the diagnostic validity of facet joint nerve blocks, and moderate evidence for therapeutic radiofrequency neurotomy and therapeutic facet joint nerve blocks in managing chronic low back pain. PMID:27190760

Safety and immunogenicity of revaccination with reduced dose intradermal and standard dose intramuscular influenza vaccines in adults 18-64 years of age.

PubMed

Gorse, Geoffrey J; Falsey, Ann R; Johnson, Carol M; Morrison, Dennis; Fried, David L; Ervin, John E; Greenberg, David P; Ozol-Godfrey, Ayca; Landolfi, Victoria; Tsang, Peter H

2013-12-05

This clinical trial examined the safety and immunogenicity of annual revaccination with Fluzone(®) Intradermal (Sanofi Pasteur, Swiftwater, PA) vaccine compared to a standard intramuscular (IM) split-virion trivalent influenza vaccine (Fluzone(®), Sanofi Pasteur). This phase II, active-controlled, multi-centre, open-label trial was conducted in 2009 and 2010, and enrolled 1250 adults 18-64 years of age who were randomly selected from participants in a phase III influenza vaccine trial the previous year (NCT00772109). Subjects who had previously received the ID vaccine were randomized 2:1 to be revaccinated with the ID or IM vaccine and those who previously received the IM vaccine were randomized 1:1. Solicited reactions were recorded on the day of vaccination and continuing for the next 7 days, non-serious adverse events for 28 days, and serious adverse events for 6 months after vaccination. Hemagglutination inhibition antibody titres were assessed pre-vaccination and at day 28. Reactions were well-tolerated and resolved in the first 7 days, but erythema, induration, swelling, pruritus and ecchymosis were reported by more subjects receiving the ID vaccine than the IM vaccine. Compared to receipt of IM vaccine in the previous year, ID vaccine in the previous year led to statistically higher rates of erythema, swelling and induration after IM vaccine in the second year. Injection-site pain and systemic reactions did not differ between ID and IM vaccines. No treatment-related serious adverse events were reported. Geometric mean antibody titres, seroprotection rates, and seroconversion rates were non-inferior for the ID and IM vaccines for all three viral strains. The ID vaccine was as immunogenic as the IM vaccine, and raised no safety concerns. It can be used interchangeably with the IM vaccine for annual revaccination in adults 18-64 years of age in consecutive years without safety concerns. Copyright © 2013 Elsevier Ltd. All rights reserved.

Attention shaping as a means to improve emotion perception deficits in outpatients with schizophrenia and impaired controls.

PubMed

Combs, Dennis R; Chapman, Dustin; Waguspack, Jace; Basso, Michael R; Penn, David L

2011-04-01

Deficits in emotion perception are common in people with schizophrenia and current research has focused on improving these deficits. In our previous research, we demonstrated that directing attention to salient facial features via attention shaping can improve these deficits among inpatients. In this study, we examined the efficacy of an enhanced attention shaping program that contains 192 emotional expressions from which 25 are randomly presented for training. We extended our previous work by using repeated administrations of the shaping intervention and testing its effect in outpatients with schizophrenia and impaired controls. Fifteen participants with schizophrenia and fourteen college student controls with emotion perception deficits were randomly assigned to 1, 3 or 5 sessions of attention shaping. Participants completed 2 outcome measures of emotion perception, the FEIT and BLERT, not presented during the training, and underwent eye tracking at pre and post-tests. All conditions and groups improved, but the largest improvements on the BLERT and FEIT were found for persons assigned to the 5 session condition. Performance on the shaping program was positively correlated with the two outcome measures of emotion perception. There was less support for changes in visual scanning of faces as there was a relative reduction in total scanning time from pre-test to post-test. Results are interpreted in terms of the efficacy of attention shaping as a means to improve emotion perception deficits. Copyright © 2010 Elsevier B.V. All rights reserved.

Life skills, mathematical reasoning and critical thinking: a curriculum for the prevention of problem gambling.

PubMed

Turner, Nigel E; Macdonald, John; Somerset, Matthew

2008-09-01

Previous studies have shown that youth are two to three times more likely than adults to report gambling related problems. This paper reports on the development and pilot evaluation of a school-based problem gambling prevention curriculum. The prevention program focused on problem gambling awareness and self-monitoring skills, coping skills, and knowledge of the nature of random events. The results of a controlled experiment evaluating the students learning from the program are reported. We found significant improvement in the students' knowledge of random events, knowledge of problem gambling awareness and self-monitoring, and knowledge of coping skills. The results suggest that knowledge based material on random events, problem gambling awareness and self-monitoring skills, and coping skills can be taught. Future development of the curriculum will focus on content to expand the students' coping skill options.

Tamoxifen with ovarian function suppression versus tamoxifen alone as an adjuvant treatment for premenopausal breast cancer: a meta-analysis of published randomized controlled trials

PubMed Central

Yan, Shunchao; Li, Kai; Jiao, Xin; Zou, Huawei

2015-01-01

Background Ovarian function suppression (OFS) significantly downregulates the concentration of plasma estrogens. However, it is unclear whether it offers any survival benefits if combined with adjuvant tamoxifen treatment in premenopausal women. This meta-analysis was designed to assess data from previous studies involving adjuvant tamoxifen treatment plus OFS in premenopausal breast cancer. Methods Electronic literature databases (PubMed, Embase, the Web of Science, and the Cochrane Library) were searched for relevant randomized controlled trials published prior to February 1, 2015. Only randomized controlled trials that compared tamoxifen alone with tamoxifen plus OFS for premenopausal women with breast cancer were selected. The evaluated endpoints were disease-free survival and overall survival. Results Four randomized controlled trials comprising 6,279 patients (OFS combination, n=3,133; tamoxifen alone, n=3,146) were included in the meta-analysis. There was no significant improvement in disease-free survival or overall survival with addition of OFS in either the whole population or the hormone receptor-positive subgroup. The risk of distant recurrence was not reduced with the addition of OFS in the whole population. A subgroup analysis showed that addition of OFS significantly improved overall survival in patients who were administered chemotherapy. Conclusion Based on the available studies, concurrent administration of OFS and adjuvant tamoxifen treatment for premenopausal women with breast cancer has no effect on prolonging disease-free survival and overall survival, excluding patients who were administered chemotherapy. It should not be widely recommended, except perhaps for women who were hormone-receptor positive and who were also administered adjuvant chemotherapy. PMID:26109867

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

USGS Publications Warehouse

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

2018-01-01

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

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

PubMed

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

2015-07-09

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

A study of caloric restriction versus standard diet in overweight men with newly diagnosed prostate cancer: a randomized controlled trial

PubMed Central

Wright, Jonathan L; Plymate, Stephen; D’Oria-Cameron, Andrea; Bain, Carolyn; Haugk, Kathy; Xiao, Liren; Lin, Daniel W; Stanford, Janet L; McTiernan, Anne

2013-01-01

Introduction Obese men have an increased risk of prostate cancer (PCa)-specific mortality. Potential mechanisms include insulin and related proteins. We investigate whether a short-term caloric restriction diet in overweight/obese men with newly diagnosed PCa can lead to measurable changes in patient anthropometrics and insulin-related proteins. Methods Overweight and obese PCa patients choosing active surveillance or radical prostatectomy were randomized to a 6-week, caloric-restricted diet or to continue their current diet. Changes from baseline to end of study in anthropometrics, dietary constituents and serum proteins (insulin, c-peptide, IGF-1, adiponectin, IGF-BP3) were compared between the intervention and control groups using a Generalized Estimating Equation model. Results Nineteen patients were randomized to the intervention (N=10) or control (N=9) group. Men in the intervention group had a 1.7% (3.7 lbs.) mean decline in weight vs. 1.0% (2.0 lbs.) in controls (p<0.05), and a reduced intake of calories, total and saturated fat, protein and starch, (all p<0.1 compared to controls). There was a significant difference (p=0.002) in mean serum IGFBP-3 between the intervention (+2.8%) and control group (−6.9%). Other biomarkers changed with the diet intervention to a degree similar to previous weight loss studies but were not statistically significant compared with controls. Conclusion In this small pilot study, a 6-week caloric restricted diet in men with newly diagnosed PCa produced changes in weight, diet and serum proteins possibly related to prognosis. These results support larger-scale trials testing longer-term weight loss effects on potential PCa progression biomarkers. PMID:23775525

A randomized study of rotigotine dose response on 'off' time in advanced Parkinson's disease.

PubMed

Nicholas, Anthony P; Borgohain, Rupam; Chaná, Pedro; Surmann, Erwin; Thompson, Emily L; Bauer, Lars; Whitesides, John; Elmer, Lawrence W

2014-01-01

Previous phase III studies in patients with advanced Parkinson's disease (PD) not adequately controlled on levodopa demonstrated significant reduction of 'off' time with rotigotine transdermal system up to 16 mg/24 h. However, the minimal effective dose has not been established. This international, randomized, double-blind, placebo-controlled study (SP921; NCT00522379) investigated rotigotine dose response up to 8 mg/24 h. Patients with advanced idiopathic PD (≥2.5 h of daily 'off' time on stable doses of levodopa) were randomized 1:1:1:1:1 to receive rotigotine 2, 4, 6, or 8 mg/24 h or placebo, titrated over 4 weeks and maintained for 12 weeks. The primary efficacy variable was change from baseline to end of maintenance in absolute time spent 'off'. 409/514 (80%) randomized patients completed maintenance. Mean (±SD) baseline daily 'off' times (h/day) were placebo: 6.4 (±2.5), rotigotine 2-8 mg/24 h: 6.4 (±2.6). Rotigotine 8 mg/24 h was the minimal dose to significantly reduce 'off' time versus placebo. LS mean (±SE) absolute change in daily 'off' time (h/day) from baseline was -2.4 (±0.28) with rotigotine 8 mg/24 h, and -1.5 (±0.26) with placebo; absolute change in 'off' time in the 8 mg/24 h group compared with placebo was -0.85 h/day (95% CI -1.59, -0.11; p = 0.024). There was an apparent dose-dependent trend. Adverse events (AEs) reported at a higher incidence in the rotigotine 8 mg/24 h group versus placebo included application site reactions, nausea, dry mouth, and dyskinesia; there was no worsening of insomnia, somnolence, orthostatic hypotension, confusional state or hallucinations, even in patients ≥75 years of age. The minimal statistically significant effective dose of rotigotine to reduce absolute 'off' time was 8 mg/24 h. The AE profile was similar to previous studies.

Blood Pressure Reduction and Secondary Stroke Prevention: A Systematic Review and Metaregression Analysis of Randomized Clinical Trials.

PubMed

Katsanos, Aristeidis H; Filippatou, Angeliki; Manios, Efstathios; Deftereos, Spyridon; Parissis, John; Frogoudaki, Alexandra; Vrettou, Agathi-Rosa; Ikonomidis, Ignatios; Pikilidou, Maria; Kargiotis, Odysseas; Voumvourakis, Konstantinos; Alexandrov, Anne W; Alexandrov, Andrei V; Tsivgoulis, Georgios

2017-01-01

Current recommendations do not specifically address the optimal blood pressure (BP) reduction for secondary stroke prevention in patients with previous cerebrovascular events. We conducted a systematic review and metaregression analysis on the association of BP reduction with recurrent stroke and cardiovascular events using data from randomized controlled clinical trials of secondary stroke prevention. For all reported events during each eligible study period, we calculated the corresponding risk ratios to express the comparison of event occurrence risk between patients randomized to antihypertensive treatment and those randomized to placebo. On the basis of the reported BP values, we performed univariate metaregression analyses according to the achieved BP values under the random-effects model (Method of Moments) for those adverse events reported in ≥10 total subgroups of included randomized controlled clinical trials. In pairwise meta-analyses, antihypertensive treatment lowered the risk for recurrent stroke (risk ratio, 0.73; 95% confidence interval, 0.62-0.87; P<0.001), disabling or fatal stroke (risk ratio, 0.71; 95% confidence interval, 0.59-0.85; P<0.001), and cardiovascular death (risk ratio, 0.85; 95% confidence interval, 0.75-0.96; P=0.01). In metaregression analyses, systolic BP reduction was linearly related to the lower risk of recurrent stroke (P=0.049), myocardial infarction (P=0.024), death from any cause (P=0.001), and cardiovascular death (P<0.001). Similarly, diastolic BP reduction was linearly related to a lower risk of recurrent stroke (P=0.026) and all-cause mortality (P=0.009). Funnel plot inspection and Egger statistical test revealed no evidence of publication bias. The extent of BP reduction is linearly associated with the magnitude of risk reduction in recurrent cerebrovascular and cardiovascular events. Strict and aggressive BP control seems to be essential for effective secondary stroke prevention. © 2016 American Heart Association, Inc.

Extending health maintenance organization insurance to the uninsured. A controlled measure of health care utilization.

PubMed

Bograd, H; Ritzwoller, D P; Calonge, N; Shields, K; Hanrahan, M

1997-04-02

To investigate the utilization of health care services of previously uninsured low-income patients after becoming insured by a health maintenance organization (HMO). Retrospective study of utilization in a previously uninsured study group compared with an age- and sex-matched randomly selected control group of commercial HMO enrollees. Group model HMO. A study group of 346 previously uninsured low-income patients and 382 controls. utpatient visits for primary and specialty care, outpatient pharmacy, laboratory, and radiology use, and inpatient admissions and hospital days over a 2-year period. Self-reported health status measures were obtained to control for differences in health status. There were no differences between the study and control groups in hospital admissions, hospital days, and measures of outpatient laboratory, pharmacy, and radiology use. The odds of having an outpatient visit per patient per month was 30% higher for the study group. Approximately half the increase in the odds ratio for outpatient visits was related to the worse self-perceived health status of the study group. While both groups utilized more services in the early phase of their enrollment, the intensity of this start-up effect was similar for both groups. Compared with a commercial group of the same age and sex, the patterns of utilization were similar and the financial costs of care were only moderately more for a previously uninsured group provided with comprehensive HMO insurance. With the growth of managed care, these data should be beneficial in the development of health care programs for the growing number of uninsured Americans.

Changes in work affect in response to lunchtime walking in previously physically inactive employees: A randomized trial.

PubMed

Thøgersen-Ntoumani, C; Loughren, E A; Kinnafick, F-E; Taylor, I M; Duda, J L; Fox, K R

2015-12-01

Physical activity may regulate affective experiences at work, but controlled studies are needed and there has been a reliance on retrospective accounts of experience. The purpose of the present study was to examine the effect of lunchtime walks on momentary work affect at the individual and group levels. Physically inactive employees (N = 56; M age = 47.68; 92.86% female) from a large university in the UK were randomized to immediate treatment or delayed treatment (DT). The DT participants completed both a control and intervention period. During the intervention period, participants partook in three weekly 30-min lunchtime group-led walks for 10 weeks. They completed twice daily affective reports at work (morning and afternoon) using mobile phones on two randomly chosen days per week. Multilevel modeling was used to analyze the data. Lunchtime walks improved enthusiasm, relaxation, and nervousness at work, although the pattern of results differed depending on whether between-group or within-person analyses were conducted. The intervention was effective in changing some affective states and may have broader implications for public health and workplace performance. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Medical Treatment of New-Onset Peripartum Cardiomyopathy: A Systematic Review of Prospective Studies.

PubMed

Desplantie, Olivier; Tremblay-Gravel, Maxime; Avram, Robert; Marquis-Gravel, Guillaume; Ducharme, Anique; Jolicoeur, E Marc

2015-12-01

Peripartum cardiomyopathy (PPCM) is a rare disorder with potentially fatal consequences, which occurs mainly in previously healthy women. The aetiology of PPCM remains unknown and various pathologic mechanisms have been proposed, including immune-mediated injuries and impaired response to oxidative stress and inflammatory cytokines. Several therapies have been studied, but few have been validated in a well-designed randomized controlled trial. In the present study we sought to review the medical treatment intended for acute PPCM. To this end, we performed a systematic review of the literature of randomized and nonrandomized prospective clinical studies. We identified 2 randomized controlled trials that evaluated the dopamine agonist bromocriptine and the inotrope levosimendan, respectively, and 1 nonrandomized study that evaluated the nonselective phosphodiesterase inhibitor pentoxifylline. We reviewed the pathophysiological, pharmacological, and clinical properties for each treatment option identified. Bromocriptine and pentoxifylline both improved left ventricular systolic function and patient-oriented clinical end points and levosimendan did not improve mortality or echocardiographic findings of PPCM. In this review we identified bromocriptine and pentoxifylline, but not levosimendan, as potentially useful agents to improve left ventricle function and outcomes in PPCM. Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Influence of therapist competence and quantity of cognitive behavioural therapy on suicidal behaviour and inpatient hospitalisation in a randomised controlled trial in borderline personality disorder: further analyses of treatment effects in the BOSCOT study.

PubMed

Norrie, John; Davidson, Kate; Tata, Philip; Gumley, Andrew

2013-09-01

We investigated the treatment effects reported from a high-quality randomized controlled trial of cognitive behavioural therapy (CBT) for 106 people with borderline personality disorder attending community-based clinics in the UK National Health Service - the BOSCOT trial. Specifically, we examined whether the amount of therapy and therapist competence had an impact on our primary outcome, the number of suicidal acts, using instrumental variables regression modelling. Randomized controlled trial. Participants from across three sites (London, Glasgow, and Ayrshire/Arran) were randomized equally to CBT for personality disorders (CBTpd) plus Treatment as Usual or to Treatment as Usual. Treatment as Usual varied between sites and individuals, but was consistent with routine treatment in the UK National Health Service at the time. CBTpd comprised an average 16 sessions (range 0-35) over 12 months. We used instrumental variable regression modelling to estimate the impact of quantity and quality of therapy received (recording activities and behaviours that took place after randomization) on number of suicidal acts and inpatient psychiatric hospitalization. A total of 101 participants provided full outcome data at 2 years post randomization. The previously reported intention-to-treat (ITT) results showed on average a reduction of 0.91 (95% confidence interval 0.15-1.67) suicidal acts over 2 years for those randomized to CBT. By incorporating the influence of quantity of therapy and therapist competence, we show that this estimate of the effect of CBTpd could be approximately two to three times greater for those receiving the right amount of therapy from a competent therapist. Trials should routinely control for and collect data on both quantity of therapy and therapist competence, which can be used, via instrumental variable regression modelling, to estimate treatment effects for optimal delivery of therapy. Such estimates complement rather than replace the ITT results, which are properly the principal analysis results from such trials. © 2013 The British Psychological Society.

Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial.

PubMed

Lisón, Juan F; Amer-Cuenca, Juan J; Piquer-Martí, Silvia; Benavent-Caballer, Vicente; Biviá-Roig, Gemma; Marín-Buck, Alejandro

2017-02-01

To evaluate the pain-relieving effect of transcutaneous electrical nerve stimulation (TENS) during office-based hysteroscopy without sedation. We conducted a randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to the active TENS, placebo TENS, or control group. The active TENS intervention consisted of a varying high-frequency (80-100 Hz), 400-microseconds, individually adjusted, high-intensity TENS application with two self-adhesive electrodes placed parallel to the spinal cord at the T10-L1 and S2-S4 levels. In the placebo group, participants were connected to the TENS unit but delivering no electrical stimulation. The primary outcome was self-reported pain intensity (0-100 mm) measured on a visual analog scale at several stages (entry, contact, biopsy, and residual). The minimum clinically relevant difference for the visual analog scale has been previously reported as 10 mm. Sample size was calculated to provide 80% power to show a 10-mm difference (α=0.0125) in the primary outcome. Secondary outcomes included duration of the procedure, vital parameters, vasovagal symptoms, and participant satisfaction index (0-10 rating scale). A total of 138 women (46 per group) participated in the study between January 2016 and April 2016. No differences were found between groups regarding age, weight, body mass index, parity status, menopausal status, or previous hysteroscopy status. Visual analog scale scores highlighted a decrease in pain in the active TENS group compared with the placebo group (entry: -11 mm, 95% confidence interval [CI] -17 to -5; contact: -21.9 mm, 95% CI -30 to -13.9; biopsy: -30.5 mm, 95% CI -47.1 to -13.8, P<.001). Moreover, the reduction in pain reached the minimum clinically relevant difference. Regarding satisfaction, results also revealed differences between active TENS and placebo groups (1.3, 95% CI 0.5-2.2, P=.001). Transcutaneous electrical nerve stimulation reduces pain and increases patient satisfaction during office hysteroscopy without sedation. ClinicalTrials.gov, www.clinicaltrials.gov, NCT02647008.

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation.

PubMed

Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A

2014-08-01

Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The 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

The effect of bench model fidelity on fluoroscopy-guided transforaminal epidural injection training: a randomized control study.

PubMed

Gonzalez-Cota, Alan; Chiravuri, Srinivas; Stansfield, R Brent; Brummett, Chad M; Hamstra, Stanley J

2013-01-01

The purpose of this study was to determine whether high-fidelity simulators provide greater benefit than low-fidelity models in training fluoroscopy-guided transforaminal epidural injection. This educational study was a single-center, prospective, randomized 3-arm pretest-posttest design with a control arm. Eighteen anesthesia and physical medicine and rehabilitation residents were instructed how to perform a fluoroscopy-guided transforaminal epidural injection and assessed by experts on a reusable injectable phantom cadaver. The high- and low-fidelity groups received 30 minutes of supervised hands-on practice according to group assignment, and the control group received 30 minutes of didactic instruction from an expert. We found no differences at posttest between the high- and low-fidelity groups on global ratings of performance (P = 0.17) or checklist scores (P = 0.81). Participants who received either form of hands-on training significantly outperformed the control group on both the global rating of performance (control vs low-fidelity, P = 0.0048; control vs high-fidelity, P = 0.0047) and the checklist (control vs low-fidelity, P = 0.0047; control vs high-fidelity, P = 0.0047). Training an epidural procedure using a low-fidelity model may be equally effective as training on a high-fidelity model. These results are consistent with previous research on a variety of interventional procedures and further demonstrate the potential impact of simple, low-fidelity training models.

Manage Your Life Online: A Web-Based Randomized Controlled Trial Evaluating the Effectiveness of a Problem-Solving Intervention in a Student Sample.

PubMed

Bird, Timothy; Mansell, Warren; Wright, Jason; Gaffney, Hannah; Tai, Sara

2018-01-25

Evidence for the efficacy of computer-based psychological interventions is growing. A number of such interventions have been found to be effective, especially for mild to moderate cases. They largely rely on psychoeducation and 'homework tasks', and are specific to certain diagnoses (e.g. depression). This paper presents the results of a web-based randomized controlled trial of Manage Your Life Online (MYLO), a program that uses artificial intelligence to engage the participant in a conversation across any problem topic. Healthy volunteers (n = 213) completed a baseline questionnaire and were randomized to the MYLO program or to an active control condition where they used the program ELIZA, which emulates a Rogerian psychotherapist. Participants completed a single session before completing post-study and 2-week follow-up measures. Analyses were per protocol with intent to follow-up. Both programs were associated with improvements in problem distress, anxiety and depression post-intervention, and again 2 weeks later, but MYLO was not found to be more effective than ELIZA. MYLO was rated as significantly more helpful than ELIZA, but there was no main effect of intervention on problem resolution. Findings are consistent with those of a previous smaller, laboratory-based trial and provide support for the acceptability and effectiveness of MYLO delivered over the internet for a non-clinical sample. The lack of a no-treatment control condition means that the effect of spontaneous recovery cannot be ruled out.

Brief Motivational Interviewing Intervention for Peer Violence and Alcohol Use in Teens: One-Year Follow-up

PubMed Central

Chermack, Stephen T.; Zimmerman, Marc A.; Shope, Jean T.; Bingham, C. Raymond; Blow, Frederic C.; Walton, Maureen A.

2012-01-01

BACKGROUND AND OBJECTIVES: Emergency department (ED) visits present an opportunity to deliver brief interventions (BIs) to reduce violence and alcohol misuse among urban adolescents at risk for future injury. Previous analyses demonstrated that a BI resulted in reductions in violence and alcohol consequences up to 6 months. This article describes findings examining the efficacy of BIs on peer violence and alcohol misuse at 12 months. METHODS: Patients (14–18 years of age) at an ED reporting past year alcohol use and aggression were enrolled in the randomized control trial, which included computerized assessment, random assignment to control group or BI delivered by a computer or therapist assisted by a computer. The main outcome measures (at baseline and 12 months) included violence (peer aggression, peer victimization, violence-related consequences) and alcohol (alcohol misuse, binge drinking, alcohol-related consequences). RESULTS: A total of 3338 adolescents were screened (88% participation). Of those, 726 screened positive for violence and alcohol use and were randomly selected; 84% completed 12-month follow-up. In comparison with the control group, the therapist assisted by a computer group showed significant reductions in peer aggression (P < .01) and peer victimization (P < .05) at 12 months. BI and control groups did not differ on alcohol-related variables at 12 months. CONCLUSIONS: Evaluation of the SafERteens intervention 1 year after an ED visit provides support for the efficacy of computer-assisted therapist brief intervention for reducing peer violence. PMID:22614776

A barber-based intervention for hypertension in African American men: design of a group randomized trial.

PubMed

Victor, Ronald G; Ravenell, Joseph E; Freeman, Anne; Bhat, Deepa G; Storm, Joy S; Shafiq, Moiz; Knowles, Patricia; Hannan, Peter J; Haley, Robert; Leonard, David

2009-01-01

Barbershops constitute potential sites for community health promotion programs targeting hypertension (HTN) in African American men but such programs previously have not been formally evaluated. A randomized trial (ClinicalTrials.gov no. NCT00325533) will test whether a continuous HTN detection and medical referral program conducted by influential peers (barbers) in a receptive community setting (barbershops) can promote treatment-seeking behavior and thus lower blood pressure (BP) among the regular customers with HTN. Barbers will offer a BP check with each haircut and encourage appropriate medical referral using real stories of other customers modeling the desired behaviors. A cohort of 16 barbershops will go through a pretest/posttest group-randomization protocol. Serial cross-sectional data collection periods (10 weeks each) will be conducted by interviewers to obtain accurate snapshots of HTN control in each barbershop before and after 10 months of either barber-based intervention or no active intervention. The primary outcome is BP control: BP <135/85 mm Hg (nondiabetic subjects) and <130/80 mm Hg (diabetic subjects) measured in the barbershop during the 2 data collection periods. The multilevel analysis plan uses hierarchical models to assess the effect of covariates on HTN control and secondary outcomes while accounting for clustering of observations within barbershops. By linking community health promotion to the health care system, this program could serve as a new model for HTN control and cardiovascular risk reduction in African American men on a nationwide scale.

Is caffeine intake a risk factor leading to infertility? A protocol of an epidemiological systematic review of controlled clinical studies.

PubMed

Cao, Huijuan; Ren, Jun; Feng, Xue; Yang, Guoyan; Liu, Jianping

2016-03-15

Previous studies showed that high dose of caffeine intake may induce some specific human reproductive system diseases, even lead to infertility. In consideration of the high consumption of caffeine according to the latest population-based survey, this review is aimed to systematically review the evidence from all controlled clinical studies of caffeine intake for infertility. Relevant randomized/quasi-randomized controlled trials, non-randomized clinical studies, cohort studies, and case-control studies will be included in this review. Participants will be either those without a history of infertility who are willing to have a baby (for prospective studies) or infertile patients with confirmed diagnosis (for retrospective studies). Caffeine or caffeine-containing beverage will be observed as the exposure factor. The key outcome will be the diagnosis of infertility in participants. All relevant published/unpublished or ongoing studies will be searched from seven databases and four online systems until December 2015. Two authors will screen the literatures and extract the data independently. Methodological quality of the included studies will be assessed by two authors according to either Risk of Bias Assessment or Newcastle-Ottawa Scale. We will use R software to analyze the data. Dose of caffeine will be quantified on a daily basis, and relative risk with their 95 % confidence interval will be measured. If data permit, meta-analysis and dose-response analysis will be conducted. Summary of findings tables will be generated using Guideline Development Tool online. PROSPERO CRD42015015714.

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

PubMed

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

2014-06-25

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

Evaluating the Sustained Health Impact of Household Chlorination of Drinking Water in Rural Haiti

PubMed Central

Harshfield, Eric; Lantagne, Daniele; Turbes, Anna; Null, Clair

2012-01-01

The Jolivert Safe Water for Families program has sold sodium hypochlorite solution (chlorine) and conducted household visits in rural Haiti since 2002. To assess the impact of the program on diarrheal disease, in 2010 we conducted a survey and water quality testing in 201 program participants and 425 control households selected at random. Fifty-six percent of participants (versus 10% of controls) had free chlorine residuals between 0.2 and 2.0 mg/L, indicating correct water treatment. Using intention-to-treat analysis, we found that significantly fewer children < 5 in participant households had an episode of diarrhea in the previous 48 hours (32% versus 52%; P < 0.001) with 59% reduced odds (odds ratio = 0.41, 95% confidence interval = 0.21–0.79). Treatment-on-treated estimates of the odds of diarrhea indicated larger program effects for participants who met more stringent verifications of participation. Diarrheal disease reduction in this long-term program was comparable with that seen in short-term randomized, controlled interventions, suggesting that household chlorination can be an effective long-term water treatment strategy. PMID:22987657

Subclinical hypothyroidism: to treat or not to treat, that is the question! A systematic review with meta-analysis on lipid profile

PubMed Central

Lau, Eva; de Sousa Pinto, Bernardo; Carvalho, Davide

2017-01-01

Previous studies suggested that subclinical hypothyroidism has a detrimental effect on cardiovascular risk factors, and that its effective treatment may have a beneficial impact on overall health. The main purpose of this review and meta-analysis was to assess whether subclinical hypothyroidism treatment is of clinical relevance, based on cardiovascular risk parameters correction. A systemic research of the literature using MEDLINE tool was performed to identify the relevant studies. Only placebo-controlled randomized control trials were included. A quantitative analysis was also performed. This systematic review and meta-analysis of randomized placebo-controlled trials assess the different impact of levothyroxine vs placebo treatment. A significant decrease in serum thyroid-stimulating hormone and total and low-density lipoprotein cholesterol was obtained with levothyroxine therapy (66, 9 and 14%, respectively) and, although modest, this could be significant in terms of reduction of the incidence of coronary artery disease. Other significant results of lipid parameters were not obtained. This systematic review provides a strong evidence-based data in favour of specific changes and beneficial effects of levothyroxine treatment. PMID:28249936

Random noise can help to improve synchronization of excimer laser pulses.

PubMed

Mingesz, Róbert; Barna, Angéla; Gingl, Zoltán; Mellár, János

2016-02-01

Recently, we have reported on a compact microcontroller-based unit developed to accurately synchronize excimer laser pulses (Mingesz et al. 2012 Fluct. Noise Lett. 11, 1240007 (doi:10.1142/S021947751240007X)). We have shown that dithering based on random jitter noise plus pseudorandom numbers can be used in the digital control system to radically reduce the long-term drift of the laser pulse from the trigger and to improve the accuracy of the synchronization. In this update paper, we present our new experimental results obtained by the use of the delay-controller unit to tune the timing of a KrF excimer laser as an addition to our previous numerical simulation results. The hardware was interfaced to the laser using optical signal paths in order to reduce sensitivity to electromagnetic interference and the control algorithm tested by simulations was applied in the experiments. We have found that the system is able to reduce the delay uncertainty very close to the theoretical limit and performs well in real applications. The simple, compact and flexible system is universal enough to also be used in various multidisciplinary applications.

Evaluating the sustained health impact of household chlorination of drinking water in rural Haiti.

PubMed

Harshfield, Eric; Lantagne, Daniele; Turbes, Anna; Null, Clair

2012-11-01

The Jolivert Safe Water for Families program has sold sodium hypochlorite solution (chlorine) and conducted household visits in rural Haiti since 2002. To assess the impact of the program on diarrheal disease, in 2010 we conducted a survey and water quality testing in 201 program participants and 425 control households selected at random. Fifty-six percent of participants (versus 10% of controls) had free chlorine residuals between 0.2 and 2.0 mg/L, indicating correct water treatment. Using intention-to-treat analysis, we found that significantly fewer children < 5 in participant households had an episode of diarrhea in the previous 48 hours (32% versus 52%; P < 0.001) with 59% reduced odds (odds ratio = 0.41, 95% confidence interval = 0.21-0.79). Treatment-on-treated estimates of the odds of diarrhea indicated larger program effects for participants who met more stringent verifications of participation. Diarrheal disease reduction in this long-term program was comparable with that seen in short-term randomized, controlled interventions, suggesting that household chlorination can be an effective long-term water treatment strategy.

Neurophysiological study on the effect of various short durations of deep breathing: A randomized controlled trial.

PubMed

Cheng, Kok Suen; Han, Ray P S; Lee, Poh Foong

2018-02-01

The study aims to study the effects of short duration deep breathing on the EEG power with topography based on parallel group randomized controlled trial design which was lacking in prior reports. 50 participants were split into 4 groups: control (CONT), deep breathing (DB) for 5 (DB5), 7 (DB7), and 9 (DB9) minutes. EEG recordings were obtained during baseline, deep breathing session, after deep breathing, and a follow-up session after 7 days of consecutive practice. Frontal theta power of DB5 and DB9 was significantly larger than that of CONT after the deep breathing session (p = 0.027 and p = 0.006, respectively) and the profound finding showed that the theta topography obtained a central-focused distribution for DB7 and DB9. The result obtained was consistent with previous literature, albeit for certain deep breathing durations only, indicating a possible linkage between the deep breathing duration and the neurophysiology of the brain. Copyright © 2017 Elsevier B.V. All rights reserved.

Upper-limb robot-assisted therapy in rehabilitation of acute stroke patients: focused review and results of new randomized controlled trial.

PubMed

Masiero, Stefano; Armani, Mario; Rosati, Giulio

2011-01-01

The successful motor rehabilitation of stroke patients requires early intensive and task-specific therapy. A recent Cochrane Review, although based on a limited number of randomized controlled trials (RCTs), showed that early robotic training of the upper limb (i.e., during acute or subacute phase) can enhance motor learning and improve functional abilities more than chronic-phase training. In this article, a new subacute-phase RCT with the Neuro-Rehabilitation-roBot (NeReBot) is presented. While in our first study we used the NeReBot in addition to conventional therapy, in this new trial we used the same device in substitution of standard proximal upper-limb rehabilitation. With this protocol, robot patients achieved similar reductions in motor impairment and enhancements in paretic upper-limb function to those gained by patients in a control group. By analyzing these results and those of previous studies, we hypothesize a new robotic protocol for acute and subacute stroke patients based on both treatment modalities (in addition and in substitution).

Texting to Reduce Alcohol Misuse (TRAM): main findings from a randomized controlled trial of a text message intervention to reduce binge drinking among disadvantaged men.

PubMed

Crombie, Iain K; Irvine, Linda; Williams, Brian; Sniehotta, Falko F; Petrie, Dennis; Jones, Claire; Norrie, John; Evans, Josie M M; Emslie, Carol; Rice, Peter M; Slane, Peter W; Humphris, Gerry; Ricketts, Ian W; Melson, Ambrose J; Donnan, Peter T; Hapca, Simona M; McKenzie, Andrew; Achison, Marcus

2018-06-01

To test the effectiveness of a theoretically based text-message intervention to reduce binge drinking among socially disadvantaged men. A multi-centre parallel group, pragmatic, individually randomized controlled trial. Community-based study conducted in four regions of Scotland. A total of 825 men aged 25-44 years recruited from socially disadvantaged areas who had two or more episodes of binge drinking (> 8 UK units on a single occasion) in the preceding 28 days: 411 men were randomized to the intervention and 414 to the control. A series of 112 interactive text messages was delivered by mobile phone during a 12-week period. The intervention was structured around the Health Action Process Approach, a comprehensive model which allows integration of a range of evidence-based behaviour change techniques. The control group received 89 texts on general health, with no mention of alcohol or use of behaviour change techniques. The primary outcome measure was the proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) at 12 months post-intervention. The proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) was 41.5% in the intervention group and 47.8% in the control group. Formal analysis showed that there was no evidence that the intervention was effective [odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.57-1.08; absolute reduction 5.7%, 95% CI = -13.3 to 1.9]. The Bayes factor for this outcome was 1.3, confirming that the results were inconclusive. The retention was high and similar in intervention (84.9%) and control (86.5%) groups. Most men in the intervention group engaged with the text messages: almost all (92%) replied to text messages and 67% replied more than 10 times. A theoretically based text-messaging intervention aimed at reducing binge drinking in disadvantaged men was not found to reduce prevalence of binge drinking at 12-month follow-up. © 2018 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Effects of Housing First on Employment and Income of Homeless Individuals: Results of a Randomized Trial.

PubMed

Poremski, Daniel; Stergiopoulos, Vicky; Braithwaite, Erika; Distasio, Jino; Nisenbaum, Rosane; Latimer, Eric

2016-06-01

Housing First is emerging as an evidence-based practice for housing and supporting people who are homeless and have a mental illness. The objective of this study was to determine whether Housing First increases the odds of obtaining competitive employment in this population and affects income, including income from informal and illegal sources. A total of 2,148 people with a mental illness were recruited from five Canadian cities while they were homeless, classified as having moderate or high needs, and randomly assigned to Housing First or usual care. Housing First participants with high needs received assertive community treatment (ACT), and those with moderate needs received intensive case management (ICM). Every three months, participants were interviewed about employment and earnings in the previous months (median follow-up=745 days). Regression models were estimated via generalized estimating equations. ICM recipients had lower odds of obtaining employment compared with the control group with moderate needs. The odds of obtaining employment among ICM recipients increased but their employment rate never exceeded that of the control group. For ACT recipients, the odds of obtaining employment were not significantly different from those of the control group. Among Housing First participants, persons employed at baseline, men, and younger participants had greater odds of employment compared with control participants. Housing First did not appear to significantly increase income. This was the first large-scale randomized controlled study of Housing First's effects on employment. Further research is needed to determine how Housing First may be enhanced to increase odds of obtaining employment.

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

PubMed

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

2015-08-01

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

The influence of short-chain essential fatty acids on children with attention-deficit/hyperactivity disorder: a double-blind placebo-controlled study.

PubMed

Raz, Raanan; Carasso, Rafael L; Yehuda, Shlomo

2009-04-01

Essential fatty acids (EFA) are needed for normal sensory, cognitive, and motor function. The EFA blood profile seems to be different in children with attention-deficit/hyperactivity disorder (ADHD) as compared to matched controls. Previous open EFA supplementation trials were successful in demonstrating significant therapeutic effects in this population, whereas most of the randomized controlled trials failed to show any benefit over placebo. The current randomized, double-blind, placebo-controlled trial tested the influence of short-chain EFA supplementation on ADHD children, using parent and teacher questionnaires and a computerized continuous performance test. A total of 73 unmedicated children aged 7-13 years with a diagnosis of ADHD participated in the study; 63 children completed the study. The EFA supplement contained 480 mg of linoleic acid and 120 mg of alpha-linolenic acid, and the placebo contained 1000 mg of vitamin C (daily amounts); both were given for a 7-week supplementation period. Analysis of variance for repeated measures revealed that both treatments ameliorated some of the symptoms, but no significant differences were found between the groups in any of the treatment effects.

Interferential and horizontal therapies in chronic low back pain due to multiple vertebral fractures: a randomized, double blind, clinical study.

PubMed

Zambito, A; Bianchini, D; Gatti, D; Rossini, M; Adami, S; Viapiana, O

2007-11-01

Chronic low back pain due to multiple vertebral fractures is of difficult management. Electrical nerve stimulation is frequently used, but its efficacy has never been properly evaluated. In a randomized placebo-controlled clinical trial, we have shown that both interferential currents and horizontal therapy are more effective than placebo for functional. Multiple vertebral fractures almost invariably ensue in chronic low back pain that remains of difficult management. Electrical nerve stimulation is frequently used but its efficacy has never been properly evaluated. One hundred and fifteen women with chronic back pain due to previous multiple vertebral osteoporotic fractures (CBPMF) were randomly assigned to either interferential currents (IFT), horizontal therapy (HT) or sham HT administered for 30 minutes daily for 5 days per week for two weeks together with a standard exercise program. Efficacy assessment was obtained at baseline and at week 2, 6 and 14 and included a functional questionnaire (Backill), the standard visual analog scale (VAS) and the mean analgesic consumption. At week 2 a significant and similar improvement in both the VAS and Backill score was observed in the three groups. The two scores continued to improve in the two active groups with changes significantly (p < 0.001) greater than those observed in control patients at week 6 and 14. The use of analgesic medications improved only in the HT group. This randomized double-blind controlled study provides the first evidence that IFT and HT therapy are significantly effective in alleviating both pain and disability in patients with CBPMF.

Random fiber lasers based on artificially controlled backscattering fibers

NASA Astrophysics Data System (ADS)

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

2017-10-01

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

Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial.

PubMed

Kuhmmer, Regina; Lima, Karine Margarites; Ribeiro, Rodrigo Antonini; Hammes, Luciano Serpa; Bastos, Gisele Alsina Nader; Cotta de Souza, Maria Claudia Schardosim; Polanczyk, Carisi Anne; Soares Rollin, Guilherme Alcides Flores; Caon, Suhelen; Guterres, Cátia Moreira; Araújo Leite, Leni Everson; Delabary, Tássia Scholante; Falavigna, Maicon

2015-02-25

Patient education on pharmacological therapy may increase medication adherence and decrease hospitalizations. Our aim is to evaluate the effectiveness of pharmaceutical care at emergency department discharge in patients with hypertension and/or diabetes. This is a randomized controlled trial. Participants will be recruited from a public emergency department at Restinga district in Porto Alegre, southern Brazil. A total of 380 patients will be randomly assigned into 2 groups at the moment of emergency department discharge after receiving medical orientations: an intervention group, consisting of a structured individual counseling session by a pharmacist in addition to written orientations, or a control group, consisting only of written information about the disease. Outcomes will be assessed in an ambulatory visit 2 months after the randomization. The primary outcome is the proportion of patients with high medication adherence assessed using the Morisky-Green Test and the Brief Medication Questionnaire. The secondary outcomes are reduction of blood pressure, glycated hemoglobin, fasting plasma glucose, quality of life and number of visits to the emergency department. Pharmaceutical care interventions have shown to be feasible and effective in increasing medication adherence in both hospital outpatient and community pharmacy settings. However, there have been no previous assessments of the effectiveness of pharmacy care interventions initiated in patients discharged from emergency departments. Our hypothesis is that pharmaceutical counseling is also effective in this population. ClinicalTrials.gov registration number: NCT01978925 (11 November 2013) and Brazilian Registry of Clinical Trials U1111-1149-8922 (5 November 2013).

Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial.

PubMed

Diéras, Véronique; Miles, David; Verma, Sunil; Pegram, Mark; Welslau, Manfred; Baselga, José; Krop, Ian E; Blackwell, Kim; Hoersch, Silke; Xu, Jin; Green, Marjorie; Gianni, Luca

2017-06-01

The antibody-drug conjugate trastuzumab emtansine is indicated for the treatment of patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. Approval of this drug was based on progression-free survival and interim overall survival data from the phase 3 EMILIA study. In this report, we present a descriptive analysis of the final overall survival data from that trial. EMILIA was a randomised, international, open-label, phase 3 study of men and women aged 18 years or older with HER2-positive unresectable, locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane. Enrolled patients were randomly assigned (1:1) via a hierarchical, dynamic randomisation scheme and an interactive voice response system to trastuzumab emtansine (3·6 mg/kg intravenously every 3 weeks) or control (capecitabine 1000 mg/m 2 self-administered orally twice daily on days 1-14 on each 21-day cycle, plus lapatinib 1250 mg orally once daily on days 1-21). Randomisation was stratified by world region (USA vs western Europe vs or other), number of previous chemotherapy regimens for unresectable, locally advanced, or metastatic disease (0 or 1 vs >1), and disease involvement (visceral vs non-visceral). The coprimary efficacy endpoints were progression-free survival (per independent review committee assessment) and overall survival. Efficacy was analysed in the intention-to-treat population; safety was analysed in all patients who received at least one dose of study treatment, with patients analysed according to the treatment actually received. On May 30, 2012, the study protocol was amended to allow crossover from control to trastuzumab emtansine after the second interim overall survival analysis crossed the prespecified overall survival efficacy boundary. This study is registered with ClinicalTrials.gov, number NCT00829166. Between Feb 23, 2009, and Oct 13, 2011, 991 eligible patients were enrolled and randomly assigned to either trastuzumab emtansine (n=495) or capecitabine and lapatinib (control; n=496). In this final descriptive analysis, median overall survival was longer with trastuzumab emtansine than with control (29·9 months [95% CI 26·3-34·1] vs 25·9 months [95% CI 22·7-28·3]; hazard ratio 0·75 [95% CI 0·64-0·88]). 136 (27%) of 496 patients crossed over from control to trastuzumab emtansine after the second interim overall survival analysis (median follow-up duration 24·1 months [IQR 19·5-26·1]). Of those patients originally randomly assigned to trastuzumab emtansine, 254 (51%) of 495 received capecitabine and 241 [49%] of 495 received lapatinib (separately or in combination) after study drug discontinuation. In the safety population (488 patients treated with capecitabine plus lapatinib, 490 patients treated with trastuzumab emtansine), fewer grade 3 or worse adverse events occurred with trastuzumab emtansine (233 [48%] of 490) than with capecitabine plus lapatinib control treatment (291 [60%] of 488). In the control group, the most frequently reported grade 3 or worse adverse events were diarrhoea (103 [21%] of 488 patients) followed by palmar-plantar erythrodysaesthesia syndrome (87 [18%]), and vomiting (24 [5%]). The safety profile of trastuzumab emtansine was similar to that reported previously; the most frequently reported grade 3 or worse adverse events in the trastuzumab emtansine group were thrombocytopenia (70 [14%] of 490), increased aspartate aminotransferase levels (22 [5%]), and anaemia (19 [4%]). Nine patients died from adverse events; five of these deaths were judged to be related to treatment (two in the control group [coronary artery disease and multiorgan failure] and three in the trastuzumab emtansine group [metabolic encephalopathy, neutropenic sepsis, and acute myeloid leukaemia]). This descriptive analysis of final overall survival in the EMILIA trial shows that trastuzumab emtansine improved overall survival in patients with previously treated HER2-positive metastatic breast cancer even in the presence of crossover treatment. The safety profile was similar to that reported in previous analyses, reaffirming trastuzumab emtansine as an efficacious and tolerable treatment in this patient population. F Hoffmann-La Roche/Genentech. Copyright © 2017 Elsevier Ltd. All rights reserved.

Amnioinfusion for women with a singleton breech presentation and a previous failed external cephalic version: a randomized controlled trial.

PubMed

Diguisto, Caroline; Winer, Norbert; Descriaud, Celine; Tavernier, Elsa; Weymuller, Victoire; Giraudeau, Bruno; Perrotin, Franck

2018-04-01

Our trial aimed to assess the effectiveness of amnioinfusion for a second attempt at external cephalic version (ECV). This open randomized controlled trial was planned with a sequential design. Women at a term ≥36 weeks of gestation with a singleton fetus in breech presentation and a first unsuccessful ECV were recruited in two level-3 maternity units. They were randomly allocated to transabdominal amnioinfusion with a 500-mL saline solution under ultrasound surveillance or no amnioinfusion before the second ECV attempt. Trained senior obstetricians performed all procedures. The primary outcome was the cephalic presentation rate at delivery. Analyses were conducted according to intention to treat (NCT00465712). Recruitment difficulties led to stopping the trial after a 57-month period, 119 women were randomized: 59 allocated to amnioinfusion + ECV and 60 to ECV only. Data were analyzed without applying the sequential feature of the design. The rate of cephalic presentation at delivery did not differ significantly according to whether the second version attempt was or was not preceded by amnioinfusion (20 versus 12%, p = .20). Premature rupture of the membranes occurred for 15% of the women in the amnioinfusion group. Amnioinfusion before a second attempt to external version does not significantly increase the rate of cephalic presentation at delivery.

Telephone based cognitive behavioral therapy targeting major depression among urban dwelling, low income people living with HIV/AIDS: results of a randomized controlled trial.

PubMed

Himelhoch, Seth; Medoff, Deborah; Maxfield, Jennifer; Dihmes, Sarah; Dixon, Lisa; Robinson, Charles; Potts, Wendy; Mohr, David C

2013-10-01

This pilot randomized controlled trial evaluated a previously developed manualized telephone based cognitive behavioral therapy (T-CBT) intervention compared to face-to-face (f2f) therapy among low-income, urban dwelling HIV infected depressed individuals. The primary outcome was the reduction of depressive symptoms as measured by the Hamliton rating scale for depression scale. The secondary outcome was adherence to HAART as measured by random telephone based pill counts. Outcome measures were collected by trained research assistants masked to treatment allocation. Analysis was based on intention-to-treat. Thirty-four participants met eligibility criteria and were randomly assigned to receive T-CBT (n = 16) or f2f (n = 18). There was no statistically significant difference in depression treatment outcomes comparing f2f to T-CBT. Within group evaluation demonstrated that both the T-CBT and the f2f psychotherapy groups resulted in significant reductions in depressive symptoms. Those who received the T-CBT were significantly more likely to maintain their adherence to antiretroviral medication compared to the f2f treatment. None of the participants discontinued treatment due to adverse events. T-CBT can be delivered to low-income, urban dwelling HIV infected depressed individuals resulting in significant reductions in depression symptoms and improved adherence to antiretroviral medication. Clinical Trial.gov identifier: NCT01055158.

Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.

PubMed

Adams, Lindsay B; Chang, Craig; Pope, Janet; Kim, Yeonsoo; Liu, Pei; Yates, Amy

2016-05-01

Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.

Provable classically intractable sampling with measurement-based computation in constant time

NASA Astrophysics Data System (ADS)

Sanders, Stephen; Miller, Jacob; Miyake, Akimasa

We present a constant-time measurement-based quantum computation (MQC) protocol to perform a classically intractable sampling problem. We sample from the output probability distribution of a subclass of the instantaneous quantum polynomial time circuits introduced by Bremner, Montanaro and Shepherd. In contrast with the usual circuit model, our MQC implementation includes additional randomness due to byproduct operators associated with the computation. Despite this additional randomness we show that our sampling task cannot be efficiently simulated by a classical computer. We extend previous results to verify the quantum supremacy of our sampling protocol efficiently using only single-qubit Pauli measurements. Center for Quantum Information and Control, Department of Physics and Astronomy, University of New Mexico, Albuquerque, NM 87131, USA.

Prophylactic tetracycline does not diminish the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash: results from the North Central Cancer Treatment Group (Supplementary N03CB).

PubMed

Jatoi, Aminah; Dakhil, Shaker R; Sloan, Jeff A; Kugler, John W; Rowland, Kendrith M; Schaefer, Paul L; Novotny, Paul J; Wender, Donald B; Gross, Howard M; Loprinzi, Charles L

2011-10-01

Previous studies suggest tetracycline and other antibiotics lessen the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash. This study sought to confirm such findings. Patients starting an EGFR inhibitor were eligible for this randomized, double-blinded, placebo-controlled study and had to be rash-free. They were then randomly assigned to tetracycline 500 mg orally twice a day for 28 days versus a placebo. Rash development and severity (monthly physician assessment and weekly patient-reported questionnaires), quality of life (SKINDEX-16), and adverse events were monitored during the 4-week intervention and then for an additional 4 weeks. The primary objective was to compare the incidence of grade 2 or worse rash between study arms; 32 patients per group provided a 90% probability of detecting a 40% difference in incidence with a type I error rate of 0.05 (two-sided). Sixty-five patients were enrolled, and groups were balanced on baseline characteristics. During the first 4 weeks, healthcare provider-reported data found that 27 tetracycline-treated patients (82%) and 24 placebo-exposed patients (75%) developed a rash. This rash was a grade 2+ in 17 (52%) and 14 (44%), respectively (p = 0.62). Comparable grade 2+ rash rates were observed during weeks 5 through 8 as well as with patient-reported rash data throughout the study period. Quality of life was comparable across study arms, and tetracycline was well tolerated. Although previous studies suggest otherwise, this randomized, double-blinded, placebo-controlled study did not find that tetracycline lessened rash incidence or severity in patients who were taking EGFR inhibitors.

OpT2mise: a randomized controlled trial to compare insulin pump therapy with multiple daily injections in the treatment of type 2 diabetes-research design and methods.

PubMed

Aronson, Ronnie; Cohen, Ohad; Conget, Ignacio; Runzis, Sarah; Castaneda, Javier; de Portu, Simona; Lee, Scott; Reznik, Yves

2014-07-01

In insulin-requiring type 2 diabetes patients, current insulin therapy approaches such as basal-alone or basal-bolus multiple daily injections (MDI) have not consistently provided achievement of optimal glycemic control. Previous studies have suggested a potential benefit of continuous subcutaneous insulin infusion (CSII) in these patients. The OpT2mise study is a multicenter, randomized, trial comparing CSII with MDI in a large cohort of subjects with evidence of persistent hyperglycemia despite previous MDI therapy. Subjects were enrolled into a run-in period for optimization of their MDI insulin regimen. Subjects showing persistent hyperglycemia (glycated hemoglobin [HbA1c] ≥8% and ≤12%) were then randomly assigned to CSII or continuing an MDI regimen for a 6-month phase followed by a single crossover of the MDI arm, switching to CSII. The primary end point is the between-group difference in mean change in HbA1c from baseline to 6 months. Secondary end points include change in mean 24-h glucose values, area under the curve and time spent in hypoglycemia and hyperglycemia, measures of glycemic excursions, change in postprandial hyperglycemia, and evaluation of treatment satisfaction. Safety end points include hypoglycemia, hospital admissions, and emergency room visits. When subject enrollment was completed in May 2013, 495 subjects had been enrolled in the study. The study completion for the primary end point is expected in January 2014. OpT2mise will represent the largest studied homogeneous cohort of type 2 diabetes patients with persistent hyperglycemia despite optimized MDI therapy. OpT2mise will help define the role of CSII in insulin intensification and define its safety, rate of hypoglycemia, patient adherence, and patient satisfaction.

[Antibiotic prophylaxis with prulifloxacin in women undergoing induced abortion: a randomized controlled trial].

PubMed

Caruso, S; Di Mari, L; Cacciatore, A; Mammana, G; Agnello, C; Cianci, A

2008-02-01

To verify the efficacy of prulifloxacin in prevention of infective morbidity in women undergoing first trimester induced abortion. The aim of the study was to observe the incidence of infection during four weeks following abortion by monitoring the symptoms which require general practitioner prescription or hospitalization. Randomized controlled trial carried on by the Research Group for Sexology, Familiar Planning Service of the Department of Microbiological and Gynecological Science, University of Catania from September 2005 to March 2007. The study included 466 women, ranging in age from 14 to 44 years (mean age 26.7), who were randomized in three groups: group A (153 subjects) treated with 600 mg daily of prulifloxacin for 5 days after abortion; group B (155 subjects) treated with 600 mg daily of prulifloxacin for 3 days after abortion; group C (158 subjects) treated with 600 mg daily of prulifloxacin one day before and 2 days after abortion. Two hundred sixteen were nulliparous (47%), 96 were pluriparous (38.5%). Thirty-two nulliparous (15%) were under eighteen. Among pluriparous, 96 (38.5%) have had previous surgery delivery and 154 (61.5%) spontaneous delivery; moreover, 56 women have had previous surgical interruption during the first-trimester of pregnancy. Surgical abortion was practiced in a range of gestational age between 6th and 11th week of amenorrhea (average week 8.2). The percentage of pelvic inflammatory disease symptoms (pain, fever, leucoxantorrhea ) were about 10.5 in group A, 7.1 in group B and 2.5 in group C. Group C protocol was statistically more effective than group A protocol (P<0.05), but not than group B, even if prevalence of adverse events were less. Antibiotic prophylaxis before surgical abortion and shortening supplies after abortion is more effective than post abortion treatment alone.

Can Atypical Antipsychotic Augmentation Reduce Subsequent Treatment Failure More Effectively Among Depressed Patients with a Higher Degree of Treatment Resistance? A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Wang, Hee Ryung; Woo, Young Sup; Ahn, Hyeong Sik; Ahn, Il Min; Kim, Hyun Jung; Bahk, Won-Myong

2015-01-01

Background: Atypical antipsychotic augmentation was demonstrated to be efficacious in treatment-resistant depression (TRD) in previous meta-analyses. We investigate whether there are differences in the effect size of atypical antipsychotic augmentation in major depressive disorder according to the degree of treatment resistance. Methods: A comprehensive search of four databases identified 11 randomized controlled trials. The 11 trials, which included 3 341 participants, were pooled using a random-effects meta-analysis. Results: Atypical antipsychotic augmentation of antidepressant therapy showed superior efficacy compared to antidepressant monotherapy in TRD in terms of both response and remission rates (response, risk ratio [RR] = 1.38, 95% confidence interval [CI] = 1.25 to 1.53; remission, RR = 1.62, 95% CI = 1.42 to 1.85). In addition, regarding response rates in the TRD trials, atypical antipsychotic augmentation exhibited significantly different effect sizes according to the degree of treatment resistance (TRD 1: RR = 1.24; TRD 2: RR = 1.37; TRD 2–4: RR = 1.58). In non-TRD trials, atypical antipsychotic augmentation failed to show superior efficacy over antidepressant monotherapy in terms of remission rates (RR = 0.89; 95% CI = 0.69 to 1.14). Atypical antipsychotic augmentation of antidepressant therapy exhibits greater effect size in patients with a higher degree of treatment resistance. Conclusions: This finding strengthens the rationale for considering atypical antipsychotic augmentation among depressed patients with multiple previous treatment failures in clinical practice. The efficacy of atypical antipsychotic augmentation for non-TRD seems to be different from that for TRD and, thus, further studies of non-TRD populations are needed. PMID:25770098

Raloxifene as an Adjunctive Treatment for Postmenopausal Women With Schizophrenia: A 24-Week Double-Blind, Randomized, Parallel, Placebo-Controlled Trial

PubMed Central

Usall, Judith; Huerta-Ramos, Elena; Labad, Javier; Cobo, Jesús; Núñez, Christian; Creus, Marta; Parés, Gemma García; Cuadras, Daniel; Franco, José; Miquel, Eva; Reyes, Julio César; Roca, Mercedes

2016-01-01

The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator, appears to act similarly to estrogens on dopamine and serotonin brain systems. One previous trial by our team found that raloxifene was useful to improve negative, positive, and general psychopathological symptoms, without having the negative side effects of estrogens. In this study, we assess the utility of raloxifene in treating negative and other psychotic symptoms in postmenopausal women with schizophrenia exhibiting prominent negative symptoms. This was a 24-week, randomized, parallel, double-blind, placebo-controlled study. Patients were recruited from the inpatient and outpatient departments of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy postmenopausal women with schizophrenia (DSM-IV) were randomized to either adjunctive raloxifene (38 women) or adjunctive placebo (32 women). Psychopathological symptoms were assessed at baseline and at weeks 4, 12, and 24 with the Positive and Negative Syndrome Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS). The addition of raloxifene (60mg/d) to regular antipsychotic treatment significantly reduced negative (P = .027), general (P = .003), and total symptomatology (P = .005) measured with the PANSS during the 24-week trial, as compared to women receiving placebo. Also Alogia SANSS subscale improved more in the raloxifene (P = .048) than the placebo group. In conclusion, raloxifene improved negative and general psychopathological symptoms, compared with antipsychotic medication alone, in postmenopausal women with schizophrenia. These data replicate our previous results with a larger sample and a longer follow-up. Trial registration: NCT01573637. PMID:26591005

Analyzing social experiments as implemented: A reexamination of the evidence from the HighScope Perry Preschool Program

PubMed Central

Heckman, James; Moon, Seong Hyeok; Pinto, Rodrigo; Savelyev, Peter; Yavitz, Adam

2012-01-01

Social experiments are powerful sources of information about the effectiveness of interventions. In practice, initial randomization plans are almost always compromised. Multiple hypotheses are frequently tested. “Significant” effects are often reported with p-values that do not account for preliminary screening from a large candidate pool of possible effects. This paper develops tools for analyzing data from experiments as they are actually implemented. We apply these tools to analyze the influential HighScope Perry Preschool Program. The Perry program was a social experiment that provided preschool education and home visits to disadvantaged children during their preschool years. It was evaluated by the method of random assignment. Both treatments and controls have been followed from age 3 through age 40. Previous analyses of the Perry data assume that the planned randomization protocol was implemented. In fact, as in many social experiments, the intended randomization protocol was compromised. Accounting for compromised randomization, multiple-hypothesis testing, and small sample sizes, we find statistically significant and economically important program effects for both males and females. We also examine the representativeness of the Perry study. PMID:23255883

The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial.

PubMed

Asl Aminabadi, Naser; Erfanparast, Leila; Sohrabi, Azin; Ghertasi Oskouei, Sina; Naghili, Armaghan

2012-01-01

Dental practitioners have numerous methods to control anxiety and pain in children, and distracting the child appears to be the most common technique used for behavior management during dental procedures. The aim of the present study was to evaluate the influence of using virtual reality eyeglasses on severity of pain and anxiety during dental procedures in pediatric patients. This study included 120 healthy children aged 4-6 years. Children with no previous anxiety disorder were randomly divided into two groups, each consisting of 60 children. The study consisted of 3 consecutive treatment sessions. During the first visit fluoride therapy was carried out in both groups. In the next sessions, the groups received restorative treatment with and without virtual reality eyeglasses in a randomized single-blind-controlled crossover fashion. Then at the end of each session the subjects' pain severity was assessed using Wong Baker FACES Pain Rating Scale and state anxiety was measured by Faces version of the Modified Child Dental Anxiety Scale [MCDAS (f)]. There was a significant decrease in pain perception (P < 0.001) and state anxiety scores (P < 0.001) with the use of virtual reality eyeglasses during dental treatment. Results of this study showed that virtual reality eyeglasses can successfully decrease pain perception and state anxiety during dental treatment. 201103126036N1.

Recruitment and Baseline Characteristics of Participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)—A Randomized Controlled Lifestyle Trial †

PubMed Central

Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

2014-01-01

Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60–77 years, the dementia risk score ≥6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons. PMID:25211775

Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial.

PubMed

Liu, Zhishun; Wang, Yang; Xu, Huanfang; Wu, Jiani; He, Liyun; Jiang, John Yi; Yan, Shiyan; Du, Ruosang; Liu, Baoyan

2014-06-21

Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture. In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made. Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms. ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).

Treatment of Multiple-Resistant and/or Recurrent Cutaneous Warts With Squaric Acid Dibutylester: A Randomized, Double-blind, Vehicle-controlled Clinical Trial.

PubMed

DallʼOglio, Federica; Luca, Maria; Barresi, Sebastiano; Micali, Giuseppe

Contact immunotherapy with squaric acid dibutylester (SADBE) for cutaneous warts has been reported to be effective, although no controlled studies are available so far. The aim of this study was to evaluate the efficacy of SADBE on cutaneous warts by a randomized, double-blind, vehicle-controlled, clinical trial. Thirty-six patients were randomly assigned to SADBE (18 cases) or vehicle (18 cases) group. At 8 weeks, subjects were clinically evaluated for number/size reduction rate and for Investigator Global Assessment. Those who showed improvement extended therapy up to 40 weeks, whereas those who showed unresponsiveness were either switched to SADBE application for up to 48 weeks (if in the vehicle group) or withdrawn from the study (if under SADBE). At 8 weeks, a significant reduction in wart number (P = 0.020) and size (P = 0.010) in the SADBE group, with clearing rates of 41.2% versus 12.5% in the SADBE and vehicle groups, respectively, was observed. Nine remaining SADBE responders who underwent treatment extension up to 40 weeks achieved clearing versus 2 patients of the vehicle group who remained unresponsive. Clearing was obtained in 81.8% of patients who underwent previous ineffective vehicle treatment and had been switched to SADBE. Squaric acid dibutylester is an effective therapeutic option and is significantly more effective than vehicle.

Effects of the addition of transcranial direct current stimulation to virtual reality therapy after stroke: a pilot randomized controlled trial.

PubMed

Viana, R T; Laurentino, G E C; Souza, R J P; Fonseca, J B; Silva Filho, E M; Dias, S N; Teixeira-Salmela, L F; Monte-Silva, K K

2014-01-01

Upper limb (UL) impairment is the most common disabling deficit following a stroke. Previous studies have suggested that transcranial direct current stimulation (tDCS) enhances the effect of conventional therapies. This pilot double-blind randomized control trial aimed to determine whether or not tDCS, combined with Wii virtual reality therapy (VRT), would be superior to Wii therapy alone in improving upper limb function and quality of life in chronic stroke individuals. Twenty participants were randomly assigned either to an experimental group that received VRT and tDCS, or a control group that received VRT and sham tDCS. The therapy was delivered over 15 sessions with 13 minutes of active or sham anodal tDCS, and one hour of virtual reality therapy. The outcomes included were determined using the Fugl-Meyer scale, the Wolf motor function test, the modified Ashworth scale (MAS), grip strength, and the stroke specific quality of life scale (SSQOL). Minimal clinically important differences (MCID) were observed when assessing outcome data. Both groups demonstrated gains in all evaluated areas, except for the SSQOL-UL domain. Differences between groups were only observed in wrist spasticity levels in the experimental group, where more than 50% of the participants achieved the MCID. These findings support that tDCS, combined with VRT therapy, should be investigated and clarified further.

Randomized controlled trial comparing the effect of 8.4% sodium bicarbonate and 5% sodium chloride on raised intracranial pressure after traumatic brain injury.

PubMed

Bourdeaux, Chris P; Brown, Jules M

2011-08-01

Hypertonic sodium chloride solutions are routinely used to control raised intracranial pressure (ICP) after traumatic brain injury but have the potential to cause a hyperchloremic metabolic acidosis. Sodium bicarbonate 8.4% has previously been shown to reduce ICP and we have therefore conducted a randomized controlled trial to compare these two solutions. Patients with severe traumatic brain injury were randomly allocated to receive an equiosmolar dose of either 100 ml of sodium chloride 5% or 85 ml of sodium bicarbonate 8.4% for each episode of intracranial hypertension. ICP and blood pressure were measured continuously. Arterial pCO(2), sodium, chloride, osmolality, and pH were measured at intervals. We studied 20 episodes of intracranial hypertension in 11 patients. Treatments with 8.4% sodium bicarbonate and 5% sodium chloride reduced raised ICP effectively with a significant fall in ICP from baseline at all time points (P < 0.001). There was no significant difference in ICP with time between those episodes treated with 5% sodium chloride or 8.4% sodium bicarbonate, P = 0.504. Arterial pH was raised after treatment with 8.4% sodium bicarbonate. An equiosmolar infusion of 8.4% sodium bicarbonate is as effective as 5% sodium chloride for reduction of raised ICP after traumatic brain injury when infused over 30 min.

Mangiferin supplementation improves serum lipid profiles in overweight patients with hyperlipidemia: a double-blind randomized controlled trial.

PubMed

Na, Lixin; Zhang, Qiao; Jiang, Shuo; Du, Shanshan; Zhang, Wei; Li, Ying; Sun, Changhao; Niu, Yucun

2015-05-19

Our previous studies have shown that mangiferin decreased serum triglycerides and free fatty acids (FFAs) by increasing FFAs oxidation in both animal and cell experiments. This study sought to evaluate the effects of mangiferin on serum lipid profiles in overweight patients with hyperlipidemia. Overweight patients with hyperlipidemia (serum triglyceride ≥ 1.70 mmol/L, and total cholesterol ≥ 5.2 mmol/L) were included in this double-blind randomized controlled trial. Participants were randomly allocated to groups, either receiving mangiferin (150 mg/day) or identical placebo for 12 weeks. The lipid profile and serum levels of mangiferin, glucose, L-carnitine, β-hydroxybutyrate, and acetoacetate were determined at baseline and 12 weeks. A total of 97 participants completed the trial. Compared with the placebo control, mangiferin supplementation significantly decreased the serum levels of triglycerides and FFAs, and insulin resistance index. Mangiferin supplementation also significantly increased the serum levels of mangiferin, high-density lipoprotein cholesterol, L-carnitine, β-hydroxybutyrate, and acetoacetate, and increased lipoprotein lipase activity. However, there were no differences in the serum levels of total cholesterol, low-density lipoprotein cholesterol, serum glucose, and insulin between groups. Mangiferin supplementation could improve serum lipid profiles by reducing serum triglycerides and FFAs in overweight patients with hyperlipidemia, partly due to the promotion of FFAs oxidation.

Mangiferin supplementation improves serum lipid profiles in overweight patients with hyperlipidemia: a double-blind randomized controlled trial

PubMed Central

Na, Lixin; Zhang, Qiao; Jiang, Shuo; Du, Shanshan; Zhang, Wei; Li, Ying; Sun, Changhao; Niu, Yucun

2015-01-01

Our previous studies have shown that mangiferin decreased serum triglycerides and free fatty acids (FFAs) by increasing FFAs oxidation in both animal and cell experiments. This study sought to evaluate the effects of mangiferin on serum lipid profiles in overweight patients with hyperlipidemia. Overweight patients with hyperlipidemia (serum triglyceride ≥ 1.70 mmol/L, and total cholesterol ≥ 5.2 mmol/L) were included in this double-blind randomized controlled trial. Participants were randomly allocated to groups, either receiving mangiferin (150 mg/day) or identical placebo for 12 weeks. The lipid profile and serum levels of mangiferin, glucose, L-carnitine, β-hydroxybutyrate, and acetoacetate were determined at baseline and 12 weeks. A total of 97 participants completed the trial. Compared with the placebo control, mangiferin supplementation significantly decreased the serum levels of triglycerides and FFAs, and insulin resistance index. Mangiferin supplementation also significantly increased the serum levels of mangiferin, high-density lipoprotein cholesterol, L-carnitine, β-hydroxybutyrate, and acetoacetate, and increased lipoprotein lipase activity. However, there were no differences in the serum levels of total cholesterol, low-density lipoprotein cholesterol, serum glucose, and insulin between groups. Mangiferin supplementation could improve serum lipid profiles by reducing serum triglycerides and FFAs in overweight patients with hyperlipidemia, partly due to the promotion of FFAs oxidation. PMID:25989216

EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

PubMed Central

Acarturk, Ceren; Konuk, Emre; Cetinkaya, Mustafa; Senay, Ibrahim; Sijbrandij, Marit; Cuijpers, Pim; Aker, Tamer

2015-01-01

Background The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population. Objective Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15) or wait-list control (n=14). The main outcome measures were Impact of Event Scale-Revised (IES-R) and Beck Depression Inventory (BDI-II) at posttreatment and 4-week follow-up. Results Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64). The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92). Conclusion The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost-) effectiveness of EMDR in similar populations are needed. PMID:25989952

Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects

PubMed Central

Tay, Lee; Leon, Francisco; Vratsanos, George; Raymond, Ralph; Corbo, Michael

2007-01-01

The effect of abatacept, a selective T-cell co-stimulation modulator, on vaccination has not been previously investigated. In this open-label, single-dose, randomized, parallel-group, controlled study, the effect of a single 750 mg infusion of abatacept on the antibody response to the intramuscular tetanus toxoid vaccine (primarily a memory response to a T-cell-dependent peptide antigen) and the intramuscular 23-valent pneumococcal vaccine (a less T-cell-dependent response to a polysaccharide antigen) was measured in 80 normal healthy volunteers. Subjects were uniformly randomized to receive one of four treatments: Group A (control group), subjects received vaccines on day 1 only; Group B, subjects received vaccines 2 weeks before abatacept; Group C, subjects received vaccines 2 weeks after abatacept; and Group D, subjects received vaccines 8 weeks after abatacept. Anti-tetanus and anti-pneumococcal (Danish serotypes 2, 6B, 8, 9V, 14, 19F and 23F) antibody titers were measured 14 and 28 days after vaccination. While there were no statistically significant differences between the dosing groups, geometric mean titers following tetanus or pneumococcal vaccination were generally lower in subjects who were vaccinated 2 weeks after receiving abatacept, compared with control subjects. A positive response (defined as a twofold increase in antibody titer from baseline) to tetanus vaccination at 28 days was seen, however, in ≥ 60% of subjects across all treatment groups versus 75% of control subjects. Similarly, over 70% of abatacept-treated subjects versus all control subjects (100%) responded to at least three pneumococcal serotypes, and approximately 25–30% of abatacept-treated subjects versus 45% of control subjects responded to at least six serotypes. PMID:17425783

Effects of Video Game Training on Measures of Selective Attention and Working Memory in Older Adults: Results from a Randomized Controlled Trial.

PubMed

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Ruiz-Marquez, Eloísa; Toril, Pilar; Reales, José M

2017-01-01

Video game training with older adults potentially enhances aspects of cognition that decline with aging and could therefore offer a promising training approach. Although, previous published studies suggest that training can produce transfer, many of them have certain shortcomings. This randomized controlled trial (RCT; Clinicaltrials.gov ID: NCT02796508) tried to overcome some of these limitations by incorporating an active control group and the assessment of motivation and expectations. Seventy-five older volunteers were randomly assigned to the experimental group trained for 16 sessions with non-action video games from Lumosity , a commercial platform (http://www.lumosity.com/) or to an active control group trained for the same number of sessions with simulation strategy games. The final sample included 55 older adults (30 in the experimental group and 25 in the active control group). Participants were tested individually before and after training to assess working memory (WM) and selective attention and also reported their perceived improvement, motivation and engagement. The results showed improved performance across the training sessions. The main results were: (1) the experimental group did not show greater improvements in measures of selective attention and working memory than the active control group (the opposite occurred in the oddball task); (2) a marginal training effect was observed for the N -back task, but not for the Stroop task while both groups improved in the Corsi Blocks task. Based on these results, one can conclude that training with non-action games provide modest benefits for untrained tasks. The effect is not specific for that kind of training as a similar effect was observed for strategy video games. Groups did not differ in motivation, engagement or expectations.

Effects of online games on student performance in undergraduate physics

NASA Astrophysics Data System (ADS)

Sadiq, Irfan

The present state of physics teaching and learning is a reflection of the difficulty of the subject matter which has resulted in students' low motivation toward physics as well as lack of meaningful and deeper learning experiences. In light of an overall decline in interest in physics, an investigation of alternate teaching and learning methods and tools was appropriate. The research posed the following question: To what extent do online games about kinematics and two-dimensional motion impact student performance in undergraduate general physics as measured by a unit posttest? Two intact classes of 20 students each were randomly assigned to either the experimental group or the control group. Only the experimental group received the treatment of using online games. The duration of topics covered in the game content was identical to the lecture on kinematics and two-dimensional motion. Instructors for the experimental group incorporated online games in their regular classroom teaching, whereas those in the control group continued with their previously used curriculum without games. This study was conducted in three weekly sessions. Although students were not selected using random sampling, existing classes were randomly assigned to either the experimental group or the control group. There were 20 students in the experimental group and 20 students in the control group. The independent samples t test was conducted to compare the means of two independently sampled experimental and control groups. Analysis of covariance (ANCOVA) was used to determine if the two groups were significantly different with regard to their general physics performance on the posttest while controlling for the pretest scores. Analysis of posttest and pretest scores revealed that game-based learning did not significantly impact student performance.

Impact of a short home-based yoga programme on blood pressure in patients with hypertension: a randomized controlled trial in primary care.

PubMed

Wolff, M; Rogers, K; Erdal, B; Chalmers, J P; Sundquist, K; Midlöv, P

2016-10-01

The present study was designed to evaluate yoga's impact on blood pressure (BP) and quality of life (QOL) and on stress, depression and anxiety in patients with hypertension in a primary care setting. We conducted a multi-centre randomized controlled trial with follow-up after 12-week intervention completion. Adult primary care patients diagnosed with hypertension were randomly allocated to yoga or usual care. The intervention group performed a short home-based Kundalini yoga programme 15 min twice-daily during the 12-week intervention period. At baseline and follow-up, the participants underwent standardized BP measurements and completed questionnaires on QOL, stress, anxiety and depression. Data obtained from 191 patients (mean age 64.7 years, s.d. 8.4) allocated to yoga intervention (n=96) and control group (n=95), with a total proportion of 52% women, showed a significant reduction in systolic and diastolic BP for both groups (-3.8/-1.7 mm Hg for yoga and -4.5/-3.0 mm Hg for control groups, respectively). However, the BP reduction for the yoga group was not significantly different from control. There were small but significant improvements for the yoga group in some of the QOL and depression measures (P<0.05, Hospital Anxiety and Depression scale, HADS-D) compared with control. The findings of our study, which is the largest study from an OECD country (Organization for Economic Co-operation and Development) to date, do not support the suggestion from previous smaller studies that yoga lowers the BP. Further clinical trials are needed to confirm these findings. However, the yoga patients had other health benefits.

Effects of Video Game Training on Measures of Selective Attention and Working Memory in Older Adults: Results from a Randomized Controlled Trial

PubMed Central

Ballesteros, Soledad; Mayas, Julia; Prieto, Antonio; Ruiz-Marquez, Eloísa; Toril, Pilar; Reales, José M.

2017-01-01

Video game training with older adults potentially enhances aspects of cognition that decline with aging and could therefore offer a promising training approach. Although, previous published studies suggest that training can produce transfer, many of them have certain shortcomings. This randomized controlled trial (RCT; Clinicaltrials.gov ID: NCT02796508) tried to overcome some of these limitations by incorporating an active control group and the assessment of motivation and expectations. Seventy-five older volunteers were randomly assigned to the experimental group trained for 16 sessions with non-action video games from Lumosity, a commercial platform (http://www.lumosity.com/) or to an active control group trained for the same number of sessions with simulation strategy games. The final sample included 55 older adults (30 in the experimental group and 25 in the active control group). Participants were tested individually before and after training to assess working memory (WM) and selective attention and also reported their perceived improvement, motivation and engagement. The results showed improved performance across the training sessions. The main results were: (1) the experimental group did not show greater improvements in measures of selective attention and working memory than the active control group (the opposite occurred in the oddball task); (2) a marginal training effect was observed for the N-back task, but not for the Stroop task while both groups improved in the Corsi Blocks task. Based on these results, one can conclude that training with non-action games provide modest benefits for untrained tasks. The effect is not specific for that kind of training as a similar effect was observed for strategy video games. Groups did not differ in motivation, engagement or expectations. PMID:29163136

MRI Customized Play Therapy in Children Reduces the Need for Sedation--A Randomized Controlled Trial.

PubMed

Bharti, Bhavneet; Malhi, Prahbhjot; Khandelwal, N

2016-03-01

To evaluate the effectiveness of an MRI-specific play therapy intervention on the need for sedation in young children. All children in the age group of 4-10 y, who were advised an MRI scan over a period of one year were randomized. Exclusion criteria included children with neurodevelopmental disorders impairing cognition and children who had previously undergone diagnostic MRI. A total of 79 children were randomized to a control or an intervention condition. The intervention involved familiarizing the child with the MRI model machine, listing the steps involved in the scan to the child in vivid detail, training the child to stand still for 5 min, and conducting several dry runs with a doll or a favorite toy. The study was approved by the Institute ethical committee. The need for sedation was 41 % (n = 16) in the control group and this declined to 20 % (n = 8) in the intervention group (χ(2) = 4.13; P = 0.04). The relative risk of sedation decreased by 49 % in the intervention group as compared to the control group (RR 0.49; 95 % CI: 0.24-1.01) and this difference was statistically significant (P = 0.04). The absolute risk difference in sedation use between intervention and control group was 21 % (95 % CI 1.3 %-40.8 %). Even on adjusting for age, relative risk of sedation remained significantly lower in children undergoing play therapy as compared to the control (RR 0.57, 95 % CI: 0.32-0.98) with P value of 0.04. The use of an MRI customized play therapy with pediatric patients undergoing diagnostic MRI resulted in significant reduction of the use of sedation.

Effects of sodium intake and diet on racial differences in urinary potassium excretion: results from the Dietary Approaches to Stop Hypertension (DASH)-Sodium trial.

PubMed

Turban, Sharon; Thompson, Carol B; Parekh, Rulan S; Appel, Lawrence J

2013-01-01

We previously showed that African Americans excreted less urinary potassium than whites, even while consuming similar diets in the Dietary Approaches to Stop Hypertension (DASH) trial. We hypothesized that a low-sodium diet may eliminate these differences. Data from the DASH-Sodium randomized controlled feeding trial were analyzed. 412 adults with prehypertension or stage 1 hypertension. Random assignment to either a typical American "control" diet (1.7 g [43 mEq] potassium/2,100 kcal/d) or the DASH diet (4.1 g [105 mEq] potassium/2,100 kcal/d). Within each diet, participants received 3 levels of sodium intake in random order for 30 days. 24-hour urine samples were analyzed at the end of each period. The primary outcome was urinary potassium excretion. On the DASH diet, African Americans consistently excreted significantly less urinary potassium (mean 24-hour urinary potassium excretion, 2,594 ± 961 mg [66 ± 25 mEq]) than whites (3,412 ± 1,016 mg [87 ± 26 mEq]) at the highest sodium level; adjusted (P < 0.001); this difference was not altered by sodium level (P = 0.6 comparing white to African American difference in urinary potassium excretion on high- vs low-sodium diet). In contrast, there was a smaller but significant white-African American difference in mean daily urinary potassium excretion in participants fed the control/high-sodium diet that was not present in the control/low-sodium diet (adjusted differences of 281 mg [7 mEq]/d vs 20 mg [0.5 mEq]/d, respectively; P = 0.007). Significant interactions were found between race and diet (P < 0.001) and between race and sodium (P = 0.02). Single rather than multiple urine collections were available at each time. Lack of stool potassium and sweat potassium values. Racial differences in urinary potassium excretion depend on sodium intake and diet. Our results may help explain the previously documented large variability in urinary potassium excretion. Copyright © 2012 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label, partially controlled, 6-month extension of a previously published trial.

PubMed

Bucci, C; Tremolaterra, F; Gallotta, S; Fortunato, A; Cappello, C; Ciacci, C; Iovino, P

2014-04-01

In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul(®)) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture. This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation). Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected. Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.

Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial.

PubMed

Colombel, Jean-Frederic; Panaccione, Remo; Bossuyt, Peter; Lukas, Milan; Baert, Filip; Vaňásek, Tomas; Danalioglu, Ahmet; Novacek, Gottfried; Armuzzi, Alessandro; Hébuterne, Xavier; Travis, Simon; Danese, Silvio; Reinisch, Walter; Sandborn, William J; Rutgeerts, Paul; Hommes, Daniel; Schreiber, Stefan; Neimark, Ezequiel; Huang, Bidan; Zhou, Qian; Mendez, Paloma; Petersson, Joel; Wallace, Kori; Robinson, Anne M; Thakkar, Roopal B; D'Haens, Geert

2018-12-23

Biomarkers of intestinal inflammation, such as faecal calprotectin and C-reactive protein, have been recommended for monitoring patients with Crohn's disease, but whether their use in treatment decisions improves outcomes is unknown. We aimed to compare endoscopic and clinical outcomes in patients with moderate to severe Crohn's disease who were managed with a tight control algorithm, using clinical symptoms and biomarkers, versus patients managed with a clinical management algorithm. CALM was an open-label, randomised, controlled phase 3 study, done in 22 countries at 74 hospitals and outpatient centres, which evaluated adult patients (aged 18-75 years) with active endoscopic Crohn's disease (Crohn's Disease Endoscopic Index of Severity [CDEIS] >6; sum of CDEIS subscores of >6 in one or more segments with ulcers), a Crohn's Disease Activity Index (CDAI) of 150-450 depending on dose of prednisone at baseline, and no previous use of immunomodulators or biologics. Patients were randomly assigned at a 1:1 ratio to tight control or clinical management groups, stratified by smoking status (yes or no), weight (<70 kg or ≥70 kg), and disease duration (≤2 years or >2 years) after 8 weeks of prednisone induction therapy, or earlier if they had active disease. In both groups, treatment was escalated in a stepwise manner, from no treatment, to adalimumab induction followed by adalimumab every other week, adalimumab every week, and lastly to both weekly adalimumab and daily azathioprine. This escalation was based on meeting treatment failure criteria, which differed between groups (tight control group before and after random assignment: faecal calprotectin ≥250 μg/g, C-reactive protein ≥5mg/L, CDAI ≥150, or prednisone use in the previous week; clinical management group before random assignment: CDAI decrease of <70 points compared with baseline or CDAI >200; clinical management group after random assignment: CDAI decrease of <100 points compared with baseline or CDAI ≥200, or prednisone use in the previous week). De-escalation was possible for patients receiving weekly adalimumab and azathioprine or weekly adalimumab alone if failure criteria were not met. The primary endpoint was mucosal healing (CDEIS <4) with absence of deep ulcers 48 weeks after randomisation. Primary and safety analyses were done in the intention-to-treat population. This trial has been completed, and is registered with ClinicalTrials.gov, number NCT01235689. Between Feb 11, 2011, and Nov 3, 2016, 244 patients (mean disease duration: clinical management group, 0·9 years [SD 1·7]; tight control group, 1·0 year [2·3]) were randomly assigned to monitoring groups (n=122 per group). 29 (24%) patients in the clinical management group and 32 (26%) patients in the tight control group discontinued the study, mostly because of adverse events. A significantly higher proportion of patients in the tight control group achieved the primary endpoint at week 48 (56 [46%] of 122 patients) than in the clinical management group (37 [30%] of 122 patients), with a Cochran-Mantel-Haenszel test-adjusted risk difference of 16·1% (95% CI 3·9-28·3; p=0·010). 105 (86%) of 122 patients in the tight control group and 100 (82%) of 122 patients in the clinical management group reported treatment-emergent adverse events; no treatment-related deaths occurred. The most common adverse events were nausea (21 [17%] of 122 patients), nasopharyngitis (18 [15%]), and headache (18 [15%]) in the tight control group, and worsening Crohn's disease (35 [29%] of 122 patients), arthralgia (19 [16%]), and nasopharyngitis (18 [15%]) in the clinical management group. CALM is the first study to show that timely escalation with an anti-tumour necrosis factor therapy on the basis of clinical symptoms combined with biomarkers in patients with early Crohn's disease results in better clinical and endoscopic outcomes than symptom-driven decisions alone. Future studies should assess the effects of such a strategy on long-term outcomes such as bowel damage, surgeries, hospital admissions, and disability. AbbVie. Copyright © 2017 Elsevier Ltd. All rights reserved.

From online randomized controlled trials to participant preference studies: morphing the San Francisco Stop Smoking site into a worldwide smoking cessation resource.

PubMed

Muñoz, Ricardo F; Aguilera, Adrian; Schueller, Stephen M; Leykin, Yan; Pérez-Stable, Eliseo J

2012-06-27

Internet interventions have the potential to address many of the health problems that produce the greatest global burden of disease. We present a study illustrating this potential. The Spanish/English San Francisco Stop Smoking Internet site, which yielded quit rates of 20% or more at 12 months in published randomized controlled trials (RCTs), was modified to make it accessible to Spanish- and English-speaking smokers 18 years of age or older anywhere in the world. To illustrate that Internet interventions designed to conduct RCTs can be adapted to serve as universal health care resources. We also examine quit rates obtained in the current participant preference study (in which users could choose from all elements tested in previous RCTs) to determine whether they differ from the quit rates found in the RCTs. We modified the San Francisco Stop Smoking Internet site so that, instead of being randomly assigned to a specific intervention, participants could personalize the site by choosing among nine site elements (eg, stop smoking guide, reminder emails, journal, mood management intervention, or virtual group). Participants completed a baseline assessment, and reported smoking and mood data at 1-, 3-, 6-, and 12-month follow-ups. We assessed the modified website's reach and outcomes (quit rates), and compared the quit rates of the current participant preference study with those of the previous RCTs. In the first year of recruitment, 94,158 individuals from 152 countries and territories visited the site; 13,488 participants left some data; 9173 signed consent; 7763 completed the baseline survey; and 1955, 1362, 1106, and 1096 left 1-, 3-, 6-, and 12-month data, respectively. Observed quit rates were 38.1% (n = 668), 44.9% (n = 546), 43.6% (n = 431), and 45.4% (n = 449), respectively. The current participant preference study yielded higher observed quit rates (odds ratio 1.30) than the previous RCT when controlling for individuals' demographic and smoking characteristics. After strict RCTs are completed, Internet intervention sites can be made into worldwide health intervention resources without reducing their effectiveness. Clinicaltrials.gov NCT00721786; http://clinicaltrials.gov/ct2/show/NCT00721786 (Archived by WebCite at http://www.webcitation.org/66npiZF4y).

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial.

PubMed

Jeandidier, Nathalie; Chaillous, Lucy; Franc, Sylvia; Benhamou, Pierre-Yves; Schaepelynck, Pauline; Hanaire, Hélène; Catargi, Bogdan; Farret, Anne; Fontaine, Pierre; Guerci, Bruno; Reznik, Yves; Penfornis, Alfred; Borot, Sophie; Serusclat, Pierre; Kherbachi, Yacine; D'Orsay, Geneviève; Detournay, Bruno; Simon, Pierre; Charpentier, Guillaume

2018-04-19

Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Here, we present the protocol for a new study (Suivi A Grande Echelle d'une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. TELESAGE is a multicenter, double-randomized, open-label, three parallel-arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist's task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd). ©Nathalie Jeandidier, Lucy Chaillous, Sylvia Franc, Pierre-Yves Benhamou, Pauline Schaepelynck, Hélène Hanaire, Bogdan Catargi, Anne Farret, Pierre Fontaine, Bruno Guerci, Yves Reznik, Alfred Penfornis, Sophie Borot, Pierre Serusclat, Yacine Kherbachi, Geneviève D'Orsay, Bruno Detournay, Pierre Simon, Guillaume Charpentier. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.04.2018.

Effects of Video Game Training on Behavioral and Electrophysiological Measures of Attention and Memory: Protocol for a Randomized Controlled Trial.

PubMed

Ballesteros, Soledad; Mayas, Julia; Ruiz-Marquez, Eloisa; Prieto, Antonio; Toril, Pilar; Ponce de Leon, Laura; de Ceballos, Maria L; Reales Avilés, José Manuel

2017-01-24

Neuroplasticity-based approaches seem to offer promising ways of maintaining cognitive health in older adults and postponing the onset of cognitive decline symptoms. Although previous research suggests that training can produce transfer effects, this study was designed to overcome some limitations of previous studies by incorporating an active control group and the assessment of training expectations. The main objectives of this study are (1) to evaluate the effects of a randomized computer-based intervention consisting of training older adults with nonaction video games on brain and cognitive functions that decline with age, including attention and spatial working memory, using behavioral measures and electrophysiological recordings (event-related potentials [ERPs]) just after training and after a 6-month no-contact period; (2) to explore whether motivation, engagement, or expectations might account for possible training-related improvements; and (3) to examine whether inflammatory mechanisms assessed with noninvasive measurement of C-reactive protein in saliva impair cognitive training-induced effects. A better understanding of these mechanisms could elucidate pathways that could be targeted in the future by either behavioral or neuropsychological interventions. A single-blinded randomized controlled trial with an experimental group and an active control group, pretest, posttest, and 6-month follow-up repeated measures design is used in this study. A total of 75 cognitively healthy older adults were randomly distributed into experimental and active control groups. Participants in the experimental group received 16 1-hour training sessions with cognitive nonaction video games selected from Lumosity, a commercial brain training package. The active control group received the same number of training sessions with The Sims and SimCity, a simulation strategy game. We have recruited participants, have conducted the training protocol and pretest assessments, and are currently conducting posttest evaluations. The study will conclude in the first semester of 2017. Data analysis will take place during 2017. The primary outcome is transfer of benefit from training to attention and working memory functions and the neural mechanisms underlying possible cognitive improvements. We expect that mental stimulation with video games will improve attention and memory both at the behavioral level and in ERP components promoting brain and mental health and extending independence among elderly people by avoiding the negative personal and economic consequences of long-term care. Clinicaltrials.gov NCT02796508; https://clinicaltrials.gov/ct2/show/NCT02796508 (archived by WebCite at http://www.webcitation.org/6nFeKeFNB). ©Soledad Ballesteros, Julia Mayas, Eloisa Ruiz-Marquez, Antonio Prieto, Pilar Toril, Laura Ponce de Leon, Maria L de Ceballos, José Manuel Reales Avilés. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.01.2017.

Total hip arthroplasty after a previous pelvic osteotomy: A systematic review and meta-analysis.

PubMed

Shigemura, T; Yamamoto, Y; Murata, Y; Sato, T; Tsuchiya, R; Wada, Y

2018-06-01

There are several reports regarding total hip arthroplasty (THA) after a previous pelvic osteotomy (PO). However, to our knowledge, until now there has been no formal systematic review and meta-analysis published to summarize the clinical results of THA after a previous PO. Therefore, we conducted a systematic review and meta-analysis of results of THA after a previous PO. We focus on these questions as follows: does a previous PO affect the results of subsequent THA, such as clinical outcomes, operative time, operative blood loss, and radiological parameters. Using PubMed, Web of Science, and Cochrane Library, we searched for relevant original papers. The pooling of data was performed using RevMan software (version 5.3, Cochrane Collaboration, Oxford, UK). A p-value<0.05 was judged as significant. Standardized mean differences (SMD) were calculated for continuous data with a 95% confidence interval (CI) was reported. Statistical heterogeneity was assessed based on I 2 using standard χ 2 test. When I 2 >50%, significant heterogeneity was assumed and a random-effects model was applied for the meta-analysis. A fixed-effects model was applied in the absence of significant heterogeneity. Eleven studies were included in this meta-analysis. The pooled results indicated that there was no significant difference in postoperative Merle D'Aubigne-Postel score (I 2 =0%, SMD=-0.15, 95% CI: -0.36 to 0.06, p=0.17), postoperative Harris hip score (I 2 =60%, SMD=-0.23, 95% CI: -0.50 to 0.05, p=0.10), operative time (I 2 =86%, SMD=0.37, 95% CI: -0.09 to 0.82, p=0.11), operative blood loss (I 2 =82%, SMD=0.23, 95% CI: -0.17 to 0.63, p=0.25), and cup abduction angle (I 2 =43%, SMD=-0.08, 95% CI: -0.25 to 0.09, p=0.38) between THA with and without a previous PO. However, cup anteversion angle of THA with a previous PO was significantly smaller than that of without a previous PO (I 2 =77%, SMD=-0.63, 95% CI: -1.13 to -0.13, p=0.01). Systematic review and meta-analysis of results of THA after a previous PO was performed. A previous PO did not affect the results of subsequent THA, except for cup anteversion. Because of the low quality evidence currently available, high-quality randomized controlled trials are required. Level III, meta-analysis of case-control studies. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial

PubMed Central

2013-01-01

Background Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. Methods/Design This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. Discussion This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. Trial registration NCT01695850 PMID:24180235

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial.

PubMed

Zhong, Linda L D; Cheng, Chung Wah; Chan, Yawen; Chan, King Hong; Lam, Ting Wa; Chen, Xiao Rui; Wong, Chi Tak; Wu, Justin C Y; Bian, Zhao Xiang

2013-11-04

Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. NCT01695850.

Implementation and Operational Research: Impact of a Systems Engineering Intervention on PMTCT Service Delivery in Côte d'Ivoire, Kenya, Mozambique: A Cluster Randomized Trial.

PubMed

Rustagi, Alison Silvis; Gimbel, Sarah; Nduati, Ruth; Cuembelo, Maria de Fatima; Wasserheit, Judith N; Farquhar, Carey; Gloyd, Stephen; Sherr, Kenneth

2016-07-01

Efficacious interventions to prevent mother-to-child HIV transmission (PMTCT) have not translated well into effective programs. Previous studies of systems engineering applications to PMTCT lacked comparison groups or randomization. Thirty-six health facilities in Côte d'Ivoire, Kenya, and Mozambique were randomized to usual care or a systems engineering intervention, stratified by country and volume. The intervention guided facility staff to iteratively identify and then rectify barriers to PMTCT implementation. Registry data quantified coverage of HIV testing during first antenatal care visit, antiretrovirals (ARVs) for HIV-positive pregnant women, and screening HIV-exposed infants (HEI) for HIV by 6-8 weeks. We compared the change between baseline (January 2013-January 2014) and postintervention (January 2015-March 2015) periods using t-tests. All analyses were intent-to-treat. ARV coverage increased 3-fold [+13.3% points (95% CI: 0.5 to 26.0) in intervention vs. +4.1 (-12.6 to 20.7) in control facilities] and HEI screening increased 17-fold [+11.6 (-2.6 to 25.7) in intervention vs. +0.7 (-12.9 to 14.4) in control facilities]. In prespecified subgroup analyses, ARV coverage increased significantly in Kenya [+20.9 (-3.1 to 44.9) in intervention vs. -21.2 (-52.7 to 10.4) in controls; P = 0.02]. HEI screening increased significantly in Mozambique [+23.1 (10.3 to 35.8) in intervention vs. +3.7 (-13.1 to 20.6) in controls; P = 0.04]. HIV testing did not differ significantly between arms. In this first randomized trial of systems engineering to improve PMTCT, we saw substantially larger improvements in ARV coverage and HEI screening in intervention facilities compared with controls, which were significant in prespecified subgroups. Systems engineering could strengthen PMTCT service delivery and protect infants from HIV.

A Spectral Approach for Quenched Limit Theorems for Random Expanding Dynamical Systems

NASA Astrophysics Data System (ADS)

Dragičević, D.; Froyland, G.; González-Tokman, C.; Vaienti, S.

2018-06-01

We prove quenched versions of (i) a large deviations principle (LDP), (ii) a central limit theorem (CLT), and (iii) a local central limit theorem for non-autonomous dynamical systems. A key advance is the extension of the spectral method, commonly used in limit laws for deterministic maps, to the general random setting. We achieve this via multiplicative ergodic theory and the development of a general framework to control the regularity of Lyapunov exponents of twisted transfer operator cocycles with respect to a twist parameter. While some versions of the LDP and CLT have previously been proved with other techniques, the local central limit theorem is, to our knowledge, a completely new result, and one that demonstrates the strength of our method. Applications include non-autonomous (piecewise) expanding maps, defined by random compositions of the form {T_{σ^{n-1} ω} circ\\cdotscirc T_{σω}circ T_ω}. An important aspect of our results is that we only assume ergodicity and invertibility of the random driving {σ:Ω\\toΩ} ; in particular no expansivity or mixing properties are required.

A Spectral Approach for Quenched Limit Theorems for Random Expanding Dynamical Systems

NASA Astrophysics Data System (ADS)

Dragičević, D.; Froyland, G.; González-Tokman, C.; Vaienti, S.

2018-01-01

We prove quenched versions of (i) a large deviations principle (LDP), (ii) a central limit theorem (CLT), and (iii) a local central limit theorem for non-autonomous dynamical systems. A key advance is the extension of the spectral method, commonly used in limit laws for deterministic maps, to the general random setting. We achieve this via multiplicative ergodic theory and the development of a general framework to control the regularity of Lyapunov exponents of twisted transfer operator cocycles with respect to a twist parameter. While some versions of the LDP and CLT have previously been proved with other techniques, the local central limit theorem is, to our knowledge, a completely new result, and one that demonstrates the strength of our method. Applications include non-autonomous (piecewise) expanding maps, defined by random compositions of the form {T_{σ^{n-1} ω} circ\\cdotscirc T_{σω}circ T_ω} . An important aspect of our results is that we only assume ergodicity and invertibility of the random driving {σ:Ω\\toΩ} ; in particular no expansivity or mixing properties are required.

Preconceptional motivational interviewing interventions to reduce alcohol-exposed pregnancy risk.

PubMed

Ingersoll, Karen S; Ceperich, Sherry D; Hettema, Jennifer E; Farrell-Carnahan, Leah; Penberthy, J Kim

2013-04-01

Alcohol exposed pregnancy (AEP) is a leading cause of preventable birth defects. While randomized controlled trials (RCTs) have shown that multi-session motivational interviewing-based interventions reduce AEP risk, a one-session intervention could facilitate broader implementation. The purposes of this study were to: (1) test a one-session motivational AEP prevention intervention for community women and (2) compare outcomes to previous RCTs. Participants at risk for AEP (N=217) were randomized to motivational interviewing+assessment feedback (EARLY), informational video, or informational brochure conditions. Outcomes were drinks per drinking day (DDD), ineffective contraception rate, and AEP risk at 3 and 6 months. All interventions were associated with decreased DDD, ineffective contraception rate, and AEP risk. Participants who received EARLY had larger absolute risk reductions in ineffective contraception and AEP risk, but not DDD. Effect sizes were compared to previous RCTs. The one-session EARLY intervention had less powerful effects than multi-session AEP prevention interventions among community women, but may provide a new option in a continuum of preventive care. Copyright © 2013 Elsevier Inc. All rights reserved.

Random Number Generation and Executive Functions in Parkinson's Disease: An Event-Related Brain Potential Study.

PubMed

Münte, Thomas F; Joppich, Gregor; Däuper, Jan; Schrader, Christoph; Dengler, Reinhard; Heldmann, Marcus

2015-01-01

The generation of random sequences is considered to tax executive functions and has been reported to be impaired in Parkinson's disease (PD) previously. To assess the neurophysiological markers of random number generation in PD. Event-related potentials (ERP) were recorded in 12 PD patients and 12 age-matched normal controls (NC) while either engaging in random number generation (RNG) by pressing the number keys on a computer keyboard in a random sequence or in ordered number generation (ONG) necessitating key presses in the canonical order. Key presses were paced by an external auditory stimulus at a rate of 1 tone every 1800 ms. As a secondary task subjects had to monitor the tone-sequence for a particular target tone to which the number "0" key had to be pressed. This target tone occurred randomly and infrequently, thus creating a secondary oddball task. Behaviorally, PD patients showed an increased tendency to count in steps of one as well as a tendency towards repetition avoidance. Electrophysiologically, the amplitude of the P3 component of the ERP to the target tone of the secondary task was reduced during RNG in PD but not in NC. The behavioral findings indicate less random behavior in PD while the ERP findings suggest that this impairment comes about, because attentional resources are depleted in PD.

Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

DTIC Science & Technology

2015-02-01

Stewart. 20 August 2014: Change site PI from Helenna Nakama to Judy Kovell. 28 October 2014: MFR reviewed regarding failure to report local SAE and...failure to report was an isolated incident and after review of all previous submissions found to be the only instance. A MFR was written to the IO at WRMC...Feb 2016 – Feb 2017). Challenges TAMC coordinator began employment on 10 March 2014 and completed training. The LRMC coordinator resigned 10 July

Evidence-based emergency medicine. Update: do ophthalmic nonsteroidal anti-inflammatory drugs reduce the pain associated with simple corneal abrasion without delaying healing?

PubMed

Weaver, Christopher S; Terrell, Kevin M

2003-01-01

Some studies have suggested that ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) decrease the pain associated with corneal abrasions without impairing healing. This evidence-based emergency medicine (EBEM) critical appraisal reviews the literature, including additional studies appearing since the publication of an earlier EBEM review in 1999. The updated search for randomized controlled trials from 1999 to 2002 complemented the previous 1966 to 1999 search. The methodologic quality of the studies was assessed. Qualitative methods were used to summarize the study results. The search identified 3 studies not included in the previously published review of ophthalmic NSAIDs, yielding a total of 5 blinded, randomized, placebo-controlled trials involving NSAIDs for corneal abrasions. The methodologic quality of the new studies was somewhat higher than that of the 2 original studies and was rated as "good" to "strong." The qualitative summary indicates that NSAIDs provide greater pain relief and improvement of other subjective symptoms when compared with placebo. However, whether the reduction of pain, as measured by visual analog pain scales, exceeds the minimal clinically significant difference is equivocal. The use of ophthalmic NSAIDs may decrease the need for sedating analgesics. Ophthalmic NSAIDs appear to be useful for decreasing pain in patients with corneal abrasions who can afford the medication and who must return to work immediately, particularly where potential opioid-induced sedation is intolerable.

Assessing the impact of a school-based latrine cleaning and handwashing program on pupil absence in Nyanza Province, Kenya: A cluster-randomized trial

PubMed Central

Caruso, Bethany A.; Freeman, Matthew C.; Garn, Joshua V.; Dreibelbis, Robert; Saboori, Shadi; Muga, Richard; Rheingans, Richard

2016-01-01

Improving school water, sanitation and hygiene (WASH) conditions has been shown to be effective in reducing pupil absence and illness. However, the benefit of sanitation and hygiene promotion improvements at school may depend on the conditions of the latrines and availability of consumables. We employed a three-arm, cluster-randomized trial to determine if a low-cost, policy-relevant, environmental-level latrine cleaning intervention could a) improve latrine cleanliness, b) increase latrine use, and c) reduce absenteeism. We assessed absence via periodical roll-call among 17,564 pupils in 60 schools that previously received WASH Improvements as part of the SWASH+ project. Latrine conditions and use were also assessed using structured observation. Latrine cleanliness increased significantly during the post-intervention period among schools receiving the latrine-cleaning package compared to controls. Handwashing with soap increased as well in intervention schools relative to controls. We found no difference in latrine use and absence across arms. The additive impact of cleaning may not have been strong enough to impact absence above and beyond reductions attributable to the original WASH infrastructure improvements and basic hygiene education the schools previously received. Improving latrine conditions is important for the dignity and well being of pupils, and investments and strategies are necessary to ensure school sanitation environments are clean and pupil-friendly. PMID:25055716

Long-term followup of a phase I/II randomized, placebo-controlled trial of palifermin to prevent graft-versus-host disease (GVHD) after related donor allogeneic hematopoietic cell transplantation (HCT)

PubMed Central

Levine, John E.; Blazar, Bruce R.; DeFor, Todd; Ferrara, James L.M.; Weisdorf, Daniel J.

2008-01-01

We previously conducted a randomized, double-blind, placebo-controlled study conducted from 2000–2003 of palifermin, a recombinant human keratinocyte growth factor, dosed from 240 mcg/kg to 720 mcg/kg, in 100 allogeneic hematopoietic stem cell transplantation (HCT) recipients. Treatment with palifermin showed beneficial effects on mucositis, but no significant effect on engraftment, acute GVHD, or early survival. In addition to the effect of palifermin on mucosa, other pleotrophic effects, including more rapid immune reconstitution, have been seen in experimental transplant models. Therefore, we investigated whether with longer follow-up we could detect additional differences between the palifermin treated and placebo cohorts. We found no differences in CMV or invasive fungal infections, chronic GVHD, or long-term survival between cohorts. We conclude that the benefits of palifermin appear to primarily be limited to ameliorating mucotoxicity when given to allogeneic HCT recipients. PMID:18721764

Exploratory Analysis of Exercise Adherence Patterns with Sedentary Pregnant Women

PubMed Central

Yeo, SeonAe; Cisewski, Jessi; Lock, Eric F.; Marron, J. S.

2010-01-01

Background It is not well understood how sedentary women who wish to engage in regular exercise adhere to interventions during pregnancy and what factors may influence adherence over time. Objective To examine longitudinal patterns of pregnant women’s adherence to exercise. Methods Exploratory secondary data analyses were carried out with 124 previously sedentary pregnant women (ages 31 ± 5 years; 85% non-Hispanic White) from a randomized controlled trial. Daily exercise logs (n = 92) from 18 through 35 weeks of gestation were explored using linear regression, functional data, and principal component analyses. Results Adherence decreased as gestation week increased (p < .001); the top adherers maintained levels of adherence, and the bottom adherers decreased levels of adherence; and adherence pattern was influenced by types of exercise throughout the study period. Discussion Exercise behavior patterns were explored in a randomized controlled trial study, using chronometric data on exercise attendance. A new analytic approach revealed that sedentary pregnant women may adopt exercise habits differently from other populations. PMID:20585224

A randomized trial to evaluate the efficacy of a computer-tailored intervention to promote safer injection practices among drug users.

PubMed

Gagnon, Hélène; Godin, Gaston; Alary, Michel; Bruneau, Julie; Otis, Joanne

2010-06-01

The aim of this study was to evaluate the efficacy of a theory-based intervention to increase the use of a new syringe for each injection among injection drug users (IDUs). Users of two needle exchange programs (NEPs) were involved. At both sites, participants were assigned at random to either the experimental or the control group. Once a week for four weeks, users reported to the NEPs where they logged onto a computer and received an audiovisual message. A total of 260 IDUs were recruited. At baseline, 52.3% of participants reported that they had not always used new syringes in the previous week. The results indicate that it is possible for IDUs to adopt safer injection practices. One month after the intervention began, participants in the experimental group were using fewer dirty syringes compared to the control group (RR: 0.47 CI(95%) 0.28-0.79; P = .004). This short-term effect was no longer present 3 months later.

User's Guide to Galoper: A Program for Simulating the Shapes of Crystal Size Distributions from Growth Mechanisms - and Associated Programs

USGS Publications Warehouse

Eberl, Dennis D.; Drits, V.A.; Srodon, J.

2000-01-01

GALOPER is a computer program that simulates the shapes of crystal size distributions (CSDs) from crystal growth mechanisms. This manual describes how to use the program. The theory for the program's operation has been described previously (Eberl, Drits, and Srodon, 1998). CSDs that can be simulated using GALOPER include those that result from growth mechanisms operating in the open system, such as constant-rate nucleation and growth, nucleation with a decaying nucleation rate and growth, surface-controlled growth, supply-controlled growth, and constant-rate and random growth; and those that result from mechanisms operating in the closed system such as Ostwald ripening, random ripening, and crystal coalescence. In addition, CSDs for two types weathering reactions can be simulated. The operation of associated programs also is described, including two statistical programs used for comparing calculated with measured CSDs, a program used for calculating lognormal CSDs, and a program for arranging measured crystal sizes into size groupings (bins).

Immediate effects of blood donation on physical and cognitive performance-A randomized controlled double-blinded trial.

PubMed

Eliassen, Håkon S; Hervig, Tor; Backlund, Sebastian; Sivertsen, Joar; Iversen, Vegard Vereide; Kristoffersen, Morten; Wengaard, Eivind; Gramstad, Arne; Fosse, Theodor; Bjerkvig, Christopher K; Apelseth, Torunn; Doughty, Heidi; Strandenes, Geir

2018-06-01

The success of implementing damage control resuscitation principles pre-hospital has been at the expense of several logistic burdens including the requirements for resupply, and the question of donor safety during the development of whole blood programs. Previous studies have reported effects on physical performance after blood donation; however, none have investigated the effects of blood donation on cognitive performance. We describe a prospective double-blinded, randomized, controlled study comprised of a battery of tests: three cognitive tests, and VO2max testing on a cycle ergometer. Testing was performed 7 days before blinded donation (baseline day), immediately after donation (Day 0), and 7 days (Day 7) after donation. The inclusion criteria included being active blood donors at the Haukeland University Hospital blood bank, where eligibility requirements were met on the testing days, and providing informed consent. Participants were randomized to either the experimental (n = 26) or control group (n = 31). Control group participants underwent a 'mock donation" in which a phlebotomy needle was placed but blood was not withdrawn. In the experimental group, mean ± SEM VO2max declined 6% from 41.35 ± 1.7 mLO2/(min·kg) at baseline to 39.0 ± 1.6 mLO2/(min·kg) on Day 0 and increased to 40.51 ± 1.5 mLO2/(min·kg) on Day 7. Comparable values in the control group were 42.1 ± 1.8 mLO2/(min·kg) at baseline, 41.6 ± 1.8 mLO2/(min·kg)) on Day 1 (1% decline from baseline), and 41.8 ± 1.8 mLO2/(min·kg) on Day 7.Comparing scores of all three cognitive tests on Day 0 and Day 7 showed no significant differences (p > 0.05). Our main findings are that executive cognitive and physical performances were well maintained after whole blood donation in healthy blood donors. The findings inform postdonation guidance on when donors may be required to return to duty. Randomized, controlled, double-blinded prospective trial study, level 1.

A Monte Carlo analysis of breast screening randomized trials.

PubMed

Zamora, Luis I; Forastero, Cristina; Guirado, Damián; Lallena, Antonio M

2016-12-01

To analyze breast screening randomized trials with a Monte Carlo simulation tool. A simulation tool previously developed to simulate breast screening programmes was adapted for that purpose. The history of women participating in the trials was simulated, including a model for survival after local treatment of invasive cancers. Distributions of time gained due to screening detection against symptomatic detection and the overall screening sensitivity were used as inputs. Several randomized controlled trials were simulated. Except for the age range of women involved, all simulations used the same population characteristics and this permitted to analyze their external validity. The relative risks obtained were compared to those quoted for the trials, whose internal validity was addressed by further investigating the reasons of the disagreements observed. The Monte Carlo simulations produce results that are in good agreement with most of the randomized trials analyzed, thus indicating their methodological quality and external validity. A reduction of the breast cancer mortality around 20% appears to be a reasonable value according to the results of the trials that are methodologically correct. Discrepancies observed with Canada I and II trials may be attributed to a low mammography quality and some methodological problems. Kopparberg trial appears to show a low methodological quality. Monte Carlo simulations are a powerful tool to investigate breast screening controlled randomized trials, helping to establish those whose results are reliable enough to be extrapolated to other populations and to design the trial strategies and, eventually, adapting them during their development. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Albumin in Burn Shock Resuscitation: A Meta-Analysis of Controlled Clinical Studies.

PubMed

Navickis, Roberta J; Greenhalgh, David G; Wilkes, Mahlon M

2016-01-01

Critical appraisal of outcomes after burn shock resuscitation with albumin has previously been restricted to small relatively old randomized trials, some with high risk of bias. Extensive recent data from nonrandomized studies assessing the use of albumin can potentially reduce bias and add precision. The objective of this meta-analysis was to determine the effect of burn shock resuscitation with albumin on mortality and morbidity in adult patients. Randomized and nonrandomized controlled clinical studies evaluating mortality and morbidity in adult patients receiving albumin for burn shock resuscitation were identified by multiple methods, including computer database searches and examination of journal contents and reference lists. Extracted data were quantitatively combined by random-effects meta-analysis. Four randomized and four nonrandomized studies with 688 total adult patients were included. Treatment effects did not differ significantly between the included randomized and nonrandomized studies. Albumin infusion during the first 24 hours showed no significant overall effect on mortality. However, significant statistical heterogeneity was present, which could be abolished by excluding two studies at high risk of bias. After those exclusions, albumin infusion was associated with reduced mortality. The pooled odds ratio was 0.34 with a 95% confidence interval of 0.19 to 0.58 (P < .001). Albumin administration was also accompanied by decreased occurrence of compartment syndrome (pooled odds ratio, 0.19; 95% confidence interval, 0.07-0.50; P < .001). This meta-analysis suggests that albumin can improve outcomes of burn shock resuscitation. However, the scope and quality of current evidence are limited, and additional trials are needed.

Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke

PubMed Central

Scutt, Polly; Love, Jo; Clavé, Pere; Cohen, David; Dziewas, Rainer; Iversen, Helle K.; Ledl, Christian; Ragab, Suzanne; Soda, Hassan; Warusevitane, Anushka; Woisard, Virginie; Hamdy, Shaheen

2016-01-01

Background and Purpose— Dysphagia is common after stroke, associated with increased death and dependency, and treatment options are limited. Pharyngeal electric stimulation (PES) is a novel treatment for poststroke dysphagia that has shown promise in 3 pilot randomized controlled trials. Methods— We randomly assigned 162 patients with a recent ischemic or hemorrhagic stroke and dysphagia, defined as a penetration aspiration score (PAS) of ≥3 on video fluoroscopy, to PES or sham treatment given on 3 consecutive days. The primary outcome was swallowing safety, assessed using the PAS, at 2 weeks. Secondary outcomes included dysphagia severity, function, quality of life, and serious adverse events at 6 and 12 weeks. Results— In randomized patients, the mean age was 74 years, male 58%, ischemic stroke 89%, and PAS 4.8. The mean treatment current was 14.8 (7.9) mA and duration 9.9 (1.2) minutes per session. On the basis of previous data, 45 patients (58.4%) randomized to PES seemed to receive suboptimal stimulation. The PAS at 2 weeks, adjusted for baseline, did not differ between the randomized groups: PES 3.7 (2.0) versus sham 3.6 (1.9), P=0.60. Similarly, the secondary outcomes did not differ, including clinical swallowing and functional outcome. No serious adverse device-related events occurred. Conclusions— In patients with subacute stroke and dysphagia, PES was safe but did not improve dysphagia. Undertreatment of patients receiving PES may have contributed to the neutral result. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25681641. PMID:27165955

High dietary zinc feeding promotes persistence of multi-resistant E. coli in the swine gut.

PubMed

Ciesinski, Lisa; Guenther, Sebastian; Pieper, Robert; Kalisch, Martin; Bednorz, Carmen; Wieler, Lothar H

2018-01-01

High levels of zinc oxide are used frequently as feed additive in pigs to improve gut health and growth performance and are still suggested as an alternative to antimicrobial growth promoters. However, we have recently described an increase of multi-resistant E. coli in association to zinc feeding in piglets. This previous study focused on clonal diversity of E. coli, observing the effect on multi-resistant strains by chance. To shed further light into this highly important topic and falsify our previous findings, we performed a zinc pig feeding trial where we specifically focused on in-depth analysis of antimicrobial resistant E. coli. Under controlled experimental conditions, piglets were randomly allocated to a high dietary zinc (zinc group) and a background zinc feeding group (control group). At different ages samples were taken from feces, digesta, and mucosa and absolute E. coli numbers were determined. A total of 2665 E. coli isolates were than phenotypically tested for antimicrobial resistance and results were confirmed by minimum inhibitory concentration testing for random samples. In piglets fed with high dietary zinc, we detected a substantial increase of multi-resistant E. coli in all gut habitats tested, ranging from 28.9-30.2% multi-resistant E. coli compared to 5.8-14.0% in the control group. This increase was independent of the total number of E. coli. Interestingly, the total amount of the E. coli population decreased over time. Thus, the increase of the multi-resistant E. coli populations seems to be linked with persistence of the resistant population, caused by the influence of high dietary zinc feeding. In conclusion, these findings corroborate our previous report linking high dietary zinc feeding of piglets with the occurrence of antimicrobial resistant E. coli and therefore question the feeding of high dietary zinc oxide as alternative to antimicrobial growth promoters.

High dietary zinc feeding promotes persistence of multi-resistant E. coli in the swine gut

PubMed Central

Guenther, Sebastian; Pieper, Robert; Kalisch, Martin; Bednorz, Carmen; Wieler, Lothar H.

2018-01-01

High levels of zinc oxide are used frequently as feed additive in pigs to improve gut health and growth performance and are still suggested as an alternative to antimicrobial growth promoters. However, we have recently described an increase of multi-resistant E. coli in association to zinc feeding in piglets. This previous study focused on clonal diversity of E. coli, observing the effect on multi-resistant strains by chance. To shed further light into this highly important topic and falsify our previous findings, we performed a zinc pig feeding trial where we specifically focused on in-depth analysis of antimicrobial resistant E. coli. Under controlled experimental conditions, piglets were randomly allocated to a high dietary zinc (zinc group) and a background zinc feeding group (control group). At different ages samples were taken from feces, digesta, and mucosa and absolute E. coli numbers were determined. A total of 2665 E. coli isolates were than phenotypically tested for antimicrobial resistance and results were confirmed by minimum inhibitory concentration testing for random samples. In piglets fed with high dietary zinc, we detected a substantial increase of multi-resistant E. coli in all gut habitats tested, ranging from 28.9–30.2% multi-resistant E. coli compared to 5.8–14.0% in the control group. This increase was independent of the total number of E. coli. Interestingly, the total amount of the E. coli population decreased over time. Thus, the increase of the multi-resistant E. coli populations seems to be linked with persistence of the resistant population, caused by the influence of high dietary zinc feeding. In conclusion, these findings corroborate our previous report linking high dietary zinc feeding of piglets with the occurrence of antimicrobial resistant E. coli and therefore question the feeding of high dietary zinc oxide as alternative to antimicrobial growth promoters. PMID:29373597

Do children with grapheme-colour synaesthesia show cognitive benefits?

PubMed

Simner, Julia; Bain, Angela E

2018-02-01

Grapheme-colour synaesthesia is characterized by conscious and consistent associations between letters and colours, or between numbers and colours (e.g., synaesthetes might see A as red, 7 as green). Our study explored the development of this condition in a group of randomly sampled child synaesthetes. Two previous studies (Simner & Bain, 2013, Frontiers in Human Neuroscience, 7, 603; Simner, Harrold, Creed, Monro, & Foulkes, 2009, Brain, 132, 57) had screened over 600 primary school children to find the first randomly sampled cohort of child synaesthetes. In this study, we evaluate this cohort to ask whether their synaesthesia is associated with a particular cognitive profile of strengths and/or weaknesses. We tested our child synaesthetes at age 10-11 years in a series of cognitive tests, in comparison with matched controls and baseline norms. One previous study (Green & Goswami, 2008, Cognition, 106, 463) had suggested that child synaesthetes might perform differently to non-synaesthetes in such tasks, although those participants may have been a special type of population independent of their synaesthesia. In our own study of randomly sampled child synaesthetes, we found no significant advantages or disadvantages in a receptive vocabulary test and a memory matrix task. However, we found that synaesthetes demonstrated above-average performance in a processing-speed task and a near-significant advantage in a letter-span task (i.e., memory/recall task of letters). Our findings point to advantages for synaesthetes that go beyond those expected from enhanced coding accounts and we present the first picture of the broader cognitive profile of a randomly sampled population of child synaesthetes. © 2017 The British Psychological Society.

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

PubMed

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

2009-05-20

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

Attention Training to Reduce Attention Bias and Social Stressor Reactivity: An Attempt to Replicate and Extend Previous Findings

PubMed Central

Julian, Kristin; Beard, Courtney; Schmidt, Norman B.; Powers, Mark B.; Smits, Jasper A. J.

2012-01-01

Cognitive theories suggest that social anxiety is maintained, in part, by an attentional bias toward threat. Recent research shows that a single session of attention modification training (AMP) reduces attention bias and vulnerability to a social stressor (Amir, Weber, Beard, Bomyea, & Taylor, 2008). In addition, exercise may augment the effects of attention training by its direct effects on attentional control and inhibition, thereby allowing participants receiving the AMP to more effectively disengage attention from the threatening cues and shift attention to the neutral cues. We attempted to replicate and extend previous findings by randomizing participants (N = 112) to a single session of: a) Exercise + attention training (EX + AMP); b) Rest + attention training (REST + AMP); c) Exercise + attention control condition (EX + ACC); or d) Rest + attention control condition (REST + ACC) prior to completing a public speaking challenge. We used identical assessment and training procedures to those employed by Amir et al. (2008). Results showed there was no effect of attention training on attention bias or anxiety reactivity to the speech challenge and no interactive effects of attention training and exercise on attention bias or anxiety reactivity to the speech challenge. The failure to replicate previous findings is discussed. PMID:22466022

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.

Evaluation of the Oral Tolerance of Three Fluoride Toothpaste Formulations in a Dry Mouth Population: Results from Two Randomized Studies.

PubMed

Jose, Anto; Ward, John; Shneyer, Lucy; Skinner, Jacob; Jeal, Nathan; Cronin, Matthew; Bosma, Mary Lynn

2016-03-01

To evaluate the oral tolerance of three experimental toothpaste formulations containing sodium fluoride (NaF), compared with two marketed sodium monofluorophosphate (SMFP)-containing biotène® toothpastes, in a dry mouth population after 14 days (primary objective) and 7 days (secondary objective) of use. Toothpastes were tested in two separate dual-site, examiner-blind, randomized, parallel group studies in subjects (35-84 years) with self-reported dry mouth. Oral soft tissue (OST) and oral hard tissue (OHT) examinations were performed at screening, followed by a 7- to 28-day wash-in period using a control toothpaste. Subjects were randomized to receive a NaF-containing toothpaste (Study 1: commercially available toothpaste Pronamel® for Children, n = 82; Study 2: experimental plaque biofilm-loosening formula [PBF] toothpaste, n = 79; or experimental Gentle Mint toothpaste, n = 78) or a reference toothpaste (Study 1: biotène® Fresh Mint Original toothpaste [previously marketed formulation], n = 82; Study 2: biotène® Gentle Mint Gel toothpaste [previously marketed formulation], n = 77) during the 14-day treatment phase. Subjects brushed their teeth twice daily for one timed minute with a ribbon of toothpaste to cover the head of the toothbrush provided. Subjects received further OST and OHT examinations at Day 1 and Day 15, and an additional OST examination at Day 8. Adverse events (AEs) and serious AEs (SAEs) were reported throughout the study. Study 1: At Day 15, 42 oral treatment-emergent AEs (TEAEs) were reported in 33 subjects, of which seven in five subjects (commercially available toothpaste Pronamel for Children: n = 2; control: n = 3) were considered to be treatment-related. One SAE (dyspnea) was reported in a participant who was randomized but withdrew from the study before receiving the allocated toothpaste. Study 2: At Day 15, 41 oral TEAEs were reported in 38 subjects, of which two in two subjects (experimental Gentle Mint toothpaste: n = 1; control: n = 1) were considered treatment-related, according to the investigator. No SAEs were reported. In both studies, the experimental and reference toothpastes were well tolerated after 7 and 14 days of use. The experimental NaF-containing toothpastes offer potential alternatives to individuals with dry mouth.

The detection of problem analytes in a single proficiency test challenge in the absence of the Health Care Financing Administration rule violations.

PubMed

Cembrowski, G S; Hackney, J R; Carey, N

1993-04-01

The Clinical Laboratory Improvement Act of 1988 (CLIA 88) has dramatically changed proficiency testing (PT) practices having mandated (1) satisfactory PT for certain analytes as a condition of laboratory operation, (2) fixed PT limits for many of these "regulated" analytes, and (3) an increased number of PT specimens (n = 5) for each testing cycle. For many of these analytes, the fixed limits are much broader than the previously employed Standard Deviation Index (SDI) criteria. Paradoxically, there may be less incentive to identify and evaluate analytically significant outliers to improve the analytical process. Previously described "control rules" to evaluate these PT results are unworkable as they consider only two or three results. We used Monte Carlo simulations of Kodak Ektachem analyzers participating in PT to determine optimal control rules for the identification of PT results that are inconsistent with those from other laboratories using the same methods. The analysis of three representative analytes, potassium, creatine kinase, and iron was simulated with varying intrainstrument and interinstrument standard deviations (si and sg, respectively) obtained from the College of American Pathologists (Northfield, Ill) Quality Assurance Services data and Proficiency Test data, respectively. Analytical errors were simulated in each of the analytes and evaluated in terms of multiples of the interlaboratory SDI. Simple control rules for detecting systematic and random error were evaluated with power function graphs, graphs of probability of error detected vs magnitude of error. Based on the simulation results, we recommend screening all analytes for the occurrence of two or more observations exceeding the same +/- 1 SDI limit. For any analyte satisfying this condition, the mean of the observations should be calculated. For analytes with sg/si ratios between 1.0 and 1.5, a significant systematic error is signaled by the mean exceeding 1.0 SDI. Significant random error is signaled by one observation exceeding the +/- 3-SDI limit or the range of the observations exceeding 4 SDIs. For analytes with higher sg/si, significant systematic or random error is signaled by violation of the screening rule (having at least two observations exceeding the same +/- 1 SDI limit). Random error can also be signaled by one observation exceeding the +/- 1.5-SDI limit or the range of the observations exceeding 3 SDIs. We present a practical approach to the workup of apparent PT errors.

Design of a school-based randomized trial to reduce smoking among 13 to 15-year olds, the X:IT study.

PubMed

Andersen, Anette; Bast, Lotus Sofie; Ringgaard, Lene Winther; Wohllebe, Louise; Jensen, Poul Dengsøe; Svendsen, Maria; Dalum, Peter; Due, Pernille

2014-05-28

Adolescent smoking is still highly prevalent in Denmark. One in four 13-year olds indicates that they have tried to smoke, and one in four 15-year olds answer that they smoke regularly. Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries. Previous school-based programs to prevent smoking have shown contrasting results internationally. In Denmark, previous programs have shown limited or no effect. This indicates a need for developing a well-designed, comprehensive, and multi-component intervention aimed at Danish schools with careful implementation and thorough evaluation.This paper describes X:IT, a study including 1) the development of a 3-year school-based multi-component intervention and 2) the randomized trial investigating the effect of the intervention. The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25%. The X:IT study is based on the Theory of Triadic Influences. The theory organizes factors influencing adolescent smoking into three streams: cultural environment, social situation, and personal factors. We added a fourth stream, the community aspects. The X:IT program comprises three main components: 1) smoke-free school premises, 2) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents, and 3) a curricular component. The study encompasses process- and effect-evaluations as well as health economic analyses. Ninety-four schools in 17 municipalities were randomly allocated to the intervention (51 schools) or control (43 schools) group. At baseline in September 2010, 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire (response rate = 93.3%). The X:IT study is a large, randomized controlled trial evaluating the effect of an intervention, based on components proven to be efficient in other Nordic settings. The X:IT study directs students, their parents, and smoking prevention policies at the schools. These elements have proven to be effective tools in preventing smoking among adolescents. Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation. X:IT creates the basis for thorough effect and process evaluation, focusing on various social groups. Current Controlled Trials ISRCTN77415416.

Design of a school-based randomized trial to reduce smoking among 13 to 15-year olds, the X:IT study

PubMed Central

2014-01-01

Background Adolescent smoking is still highly prevalent in Denmark. One in four 13-year olds indicates that they have tried to smoke, and one in four 15-year olds answer that they smoke regularly. Smoking is more prevalent in socioeconomically disadvantaged populations in Denmark as well as in most Western countries. Previous school-based programs to prevent smoking have shown contrasting results internationally. In Denmark, previous programs have shown limited or no effect. This indicates a need for developing a well-designed, comprehensive, and multi-component intervention aimed at Danish schools with careful implementation and thorough evaluation. This paper describes X:IT, a study including 1) the development of a 3-year school-based multi-component intervention and 2) the randomized trial investigating the effect of the intervention. The study aims at reducing the prevalence of smoking among 13 to 15-year olds by 25%. Methods/Design The X:IT study is based on the Theory of Triadic Influences. The theory organizes factors influencing adolescent smoking into three streams: cultural environment, social situation, and personal factors. We added a fourth stream, the community aspects. The X:IT program comprises three main components: 1) smoke-free school premises, 2) parental involvement including smoke-free dialogues and smoke-free contracts between students and parents, and 3) a curricular component. The study encompasses process- and effect-evaluations as well as health economic analyses. Ninety-four schools in 17 municipalities were randomly allocated to the intervention (51 schools) or control (43 schools) group. At baseline in September 2010, 4,468 year 7 students were eligible of which 4,167 answered the baseline questionnaire (response rate = 93.3%). Discussion The X:IT study is a large, randomized controlled trial evaluating the effect of an intervention, based on components proven to be efficient in other Nordic settings. The X:IT study directs students, their parents, and smoking prevention policies at the schools. These elements have proven to be effective tools in preventing smoking among adolescents. Program implementation is thoroughly evaluated to be able to add to the current knowledge of the importance of implementation. X:IT creates the basis for thorough effect and process evaluation, focusing on various social groups. Trial registration Current Controlled Trials ISRCTN77415416. PMID:24886206

Slow-release L-Cysteine (Acetium®) Lozenge Is an Effective New Method in Smoking Cessation. A Randomized, Double-blind, Placebo-controlled Intervention.

PubMed

Syrjänen, Kari; Eronen, Katja; Hendolin, Panu; Paloheimo, Lea; Eklund, Carita; Bäckström, Anna; Suovaniemi, Osmo

2017-07-01

Because of the major health problems and annual economic burden caused by cigarette smoking, effective new tools for smoking intervention are urgently needed. Our previous randomized controlled trial (RCT) provided promising results on the efficacy of slow-release L-cysteine lozenge in smoking intervention, but the study was not adequately powered. To confirm in an adequately-powered study the results of the previous RCT implicating that effective elimination of acetaldehyde in saliva by slow-release L-cysteine (Acetium® lozenge, Biohit Oyj, Helsinki), would assist in smoking cessation by reducing acetaldehyde-enhanced nicotine addiction. On this matter, we undertook a double-blind, randomized, placebo-controlled trial comparing Acetium® lozenge and placebo in smoking intervention. A cohort of 1,998 cigarette smokers were randomly allocated to intervention (n=996) and placebo arms (n=1,002). At baseline, smoking history was recorded by a questionnaire, with nicotine dependence testing according to the Fagerström scale (FTND). The subjects used smoking diary recording the daily numbers of cigarettes, lozenges and subjective sensations of smoking. The data were analysed separately for point prevalence of abstinence (PPA) and prolonged abstinence (PA) endpoints. Altogether, 753 study subjects completed the trial per protocol (PP), 944 with violations (mITT), and the rest (n=301) were lost to follow-up (LTF). During the 6-month intervention, 331 subjects stopped smoking; 181 (18.2%) in the intervention arm and 150 (15.0%) in the placebo arm (OR=1.43; 95%CI=1.09-1.88); p=0.010). In the PP group, 170 (45.3%) quitted smoking in the intervention arm compared to 134 (35.4%) in the placebo arm (OR=1.51, 95%CI=1.12-2.02; p=0.006). In multivariate (Poisson regression) model, decreased level of smoking pleasure (p=0.010) and "smoking sensations changed" were powerful independent predictors of quit events (IRR=12.01; 95%CI=1.5-95.6). Acetium® lozenge, herein confirmed in an adequately powered study to be an effective means to aid smoking quit, represents a major breakthrough in the development of smoking intervention methods, because slow-release L-cysteine is non-toxic, with no side-effects or limitations of use. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Prevention of gestational diabetes through lifestyle intervention: study design and methods of a Finnish randomized controlled multicenter trial (RADIEL).

PubMed

Rönö, Kristiina; Stach-Lempinen, Beata; Klemetti, Miira M; Kaaja, Risto J; Pöyhönen-Alho, Maritta; Eriksson, Johan G; Koivusalo, Saila B

2014-02-14

Maternal overweight, obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide. The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before, during and after pregnancy in a primary health care setting for preventing gestational diabetes, later type 2 diabetes and other metabolic consequences. RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes (a previous history of gestational diabetes or prepregnancy BMI ≥30 kg/m2). Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics. All participants visited a study nurse every three months before and during pregnancy, and at 6 weeks, 6 and 12 months postpartum. Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers.Of the 728 women [mean age 32.5 years (SD 4.7); median parity 1 (range 0-9)] considered to be eligible for the study 235 were non-pregnant and 493 pregnant [mean gestational age 13 (range 6 to 18) weeks] at the time of enrollment. The proportion of nulliparous women was 29.8% (n = 217). Out of all participants, 79.6% of the non-pregnant and 40.4% of the pregnant women had previous gestational diabetes and 20.4% of the non-pregnant and 59.6% of the pregnant women were recruited because of a prepregnancy BMI ≥30 kg/m2. Mean BMI at first visit was 30.1 kg/m2 (SD 6.2) in the non-pregnant and 32.7 kg/m2 (SD 5.6) in the pregnant group. To our knowledge, this is the first randomized lifestyle intervention trial, which includes, besides the pregnancy period, both the prepregnancy and the postpartum period. This study design also provides an opportunity to focus upon the health of the next generation. The study is expected to produce novel information on the optimal timing and setting of interventions and for allocating resources to prevent obesity and diabetes in women of reproductive age.

Barriers to Patient Use of Control Solution for Glucose Meters: Surveys of Patients, Pharmacists, and Providers in a Metropolitan Area.

PubMed

Johnson, Jeremy L; O'Neal, Katherine S; Pack, Christopher C; Carter, Sandra M

2017-05-01

An important factor in controlling diabetes is self-monitoring of blood glucose. Manufacturers of glucose meters recommend routine use of control solution to ensure accuracy. Previous studies have demonstrated that glucose meters vary in accuracy and that patients are not using control solution as recommended. The purpose of this study is to identify potential barriers to control solution use from multiple perspectives including patient, pharmacist, and provider. This study was a prospective, observational survey design. First, 25 randomly selected chain and independent pharmacies in the Tulsa metropolitan area were audited for control solution accessibility. These pharmacies were then used to survey pharmacists, via telephone, regarding control solution inventory and perception of importance of use. Next, providers were electronically surveyed on their routine practice recommendations, while 60 patients with diabetes were randomly selected for telephone survey on use and perceptions of control solution. Twenty-five pharmacies were audited and 23 pharmacists, 60 patients, and 29 providers were surveyed. Only 39% of pharmacies stated they supplied control solution, however, only 1 pharmacy visibly stocked it. The only patient factor that appeared to have an impact on control solution usage was having type 1 versus type 2 diabetes (38% vs 15%). Providers are aware of what control solution is (62%), but only half felt it should be routine practice with 44% of those never recommending it. This study raises awareness for the need to educate patients, providers, and pharmacists about use of control solution to ensure glucose meter accuracy.

A randomized controlled trial evaluating the efficacy of a 67% sodium bicarbonate toothpaste on gingivitis.

PubMed

Lomax, A; Patel, S; Wang, N; Kakar, K; Kakar, A; Bosma, M L

2017-11-01

In previous studies, toothpastes with high levels of sodium bicarbonate (>50%) have reduced gingival inflammation and oral malodour. This study compared the effects of brushing for 6 weeks with 67% (test group) or 0% (control group) sodium bicarbonate toothpaste on gingival health. This was a single-centre, single examiner-blind, randomized, controlled, two-treatment, parallel-group study. Eligible subjects (≥18 years) had ≥20 gradable teeth, mild-to-moderate gingivitis, a positive response to bleeding on brushing and ≥20 bleeding sites. The primary objective was to compare the number of bleeding sites following twice-daily use of 67% sodium bicarbonate toothpaste or 0% sodium bicarbonate toothpaste after 6 weeks. Secondary endpoints included Modified Gingival Index (MGI), Bleeding Index (BI) and volatile sulphur compounds (VSC), assessed after 6 weeks. Safety was assessed by treatment-emergent oral soft tissue abnormalities and adverse events. Of 148 patients randomized (74 to each treatment), 66 (89.2%) completed the study in the test group, compared with 69 (93.2%) in the control group. Compared with the control group, the test group had a significant reduction in the number of bleeding sites at Week 6 (absolute difference - 11.0 [-14.0, -8.0], P < 0.0001; relative difference - 25.4%), together with significant reductions in MGI and BI (both P < 0.0001). Although the median reductions from baseline for VSC were numerically greater in the test group, the difference did not reach statistical significance (P = 0.9701). This 67% sodium bicarbonate toothpaste provided statistically significant improvements in gingival health and bleeding after 6 weeks of use. © 2016 The Authors. International Journal of Dental Hygiene Published by John Wiley & Sons Ltd.

Stepped-Wedge Cluster Randomized Controlled Trial to Promote Option B+ Retention in Central Mozambique.

PubMed

Pfeiffer, James T; Napúa, Manuel; Wagenaar, Bradley H; Chale, Falume; Hoek, Roxanne; Micek, Mark; Manuel, João; Michel, Cathy; Cowan, Jessica Greenberg; Cowan, James F; Gimbel, Sarah; Sherr, Kenneth; Gloyd, Stephen; Chapman, Rachel R

2017-11-01

This randomized trial studied performance of Option B+ in Mozambique and evaluated an enhanced retention package in public clinics. The study was conducted at 6 clinics in Manica and Sofala Provinces in central Mozambique. Seven hundred sixty-one pregnant women tested HIV+, immediately initiated antiretroviral (ARV) therapy, and were followed to track retention at 6 clinics from May 2014 to May 2015. Clinics were randomly allocated within a stepped-wedge fashion to intervention and control periods. The intervention included (1) workflow modifications and (2) active patient tracking. Retention was defined as percentage of patients returning for 30-, 60-, and 90-day medication refills within 25-35 days of previous refills. During control periods, 52.3% of women returned for 30-day refills vs. 70.8% in intervention periods [odds ratio (OR): 1.80; 95% confidence interval (CI): 1.05 to 3.08]. At 60 days, 46.1% control vs. 57.9% intervention were retained (OR: 1.82; CI: 1.06 to 3.11), and at 90 days, 38.3% control vs. 41.0% intervention (OR: 1.04; CI: 0.60 to 1.82). In prespecified subanalyses, birth before pickups was strongly associated with failure-women giving birth before ARV pickup were 33.3 times (CI: 4.4 to 250.3), 7.5 times (CI: 3.6 to 15.9), and 3.7 times (CI: 2.2 to 6.0) as likely to not return for ARV pickups at 30, 60, and 90 days, respectively. The intervention was effective at 30 and 60 days, but not at 90 days. Combined 90-day retention (40%) and adherence (22.5%) were low. Efforts to improve retention are particularly important for women giving birth before ARV refills.

Interferential and horizontal therapies in chronic low back pain: a randomized, double blind, clinical study.

PubMed

Zambito, A; Bianchini, D; Gatti, D; Viapiana, O; Rossini, M; Adami, S

2006-01-01

Chronic Low Back Pain (CLBP) is one of the most frequent medical problems. Electrical nerve stimulation is frequently used but its efficacy remains controversial. Twenty-six men and 94 women with CLBP associated with either degenerative disk disease or previous multiple vertebral osteoporotic fractures were randomly assigned to either interferential currents (IFT), horizontal therapy (HT) or sham HT administered for 10, 40 and 40 minutes, respectively, daily for 5 days per week for two weeks together with a standard flexion-extension stretching exercise program, Blind efficacy assessment were obtained at baseline and at week 2, 6 and 14 and included a functional questionnaire (Backill), the standard visual analog scale (VAS) and the mean analgesic consumption. At week 2 a significant and similar improvement in both the VAS and Backill score was observed in all three groups. The Backill score continued to improve only in the two active groups with changes significantly greater than those observed in control patients at week 14. The pain VAS score returned to baseline values at week 6 and 14 in the control group while in the IFT and HT groups it continued to improve (p< 0.01 vs controls). The use of analgesic medications significantly improved at week 14 versus pretreatment assessment and over control patients only in the HT group. This randomized double-blind controlled study provides the first evidence that IFT and HT therapy are significantly effective in alleviating both pain and disability in patients with CLBP. The placebo effect is remarkable at the beginning of the treatment but it tends to vanish within a couple of weeks.

Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial.

PubMed

Redeker, Nancy S; Knies, Andrea K; Hollenbeak, Christopher; Klar Yaggi, H; Cline, John; Andrews, Laura; Jacoby, Daniel; Sullivan, Anna; O'Connell, Meghan; Iennaco, Joanne; Finoia, Lisa; Jeon, Sangchoon

2017-04-01

Chronic insomnia is associated with disabling symptoms and decrements in functional performance. It may contribute to the development of heart failure (HF) and incident mortality. In our previous work, cognitive-behavioral therapy for insomnia (CBT-I), compared to HF self-management education, provided as an attention control condition, was feasible, acceptable, and had large effects on insomnia and fatigue among HF patients. The purpose of this randomized controlled trial (RCT) is to evaluate the sustained effects of group CBT-I compared with HF self-management education (attention control) on insomnia severity, sleep characteristics, daytime symptoms, symptom clusters, functional performance, and health care utilization among patients with stable HF. We will estimate the cost-effectiveness of CBT-I and explore the effects of CBT-I on event-free survival (EFS). Two hundred participants will be randomized in clusters to a single center parallel group (CBT-I vs. attention control) RCT. Wrist actigraphy and self-report will elicit insomnia, sleep characteristics, symptoms, and functional performance. We will use the psychomotor vigilance test to evaluate sleep loss effects and the Six Minute Walk Test to evaluate effects on daytime function. Medical record review and interviews will elicit health care utilization and EFS. Statistical methods will include general linear mixed models and latent transition analysis. Stochastic cost-effectiveness analysis with a competing risk approach will be employed to conduct the cost-effectiveness analysis. The results will be generalizable to HF patients with chronic comorbid insomnia and pave the way for future research focused on the dissemination and translation of CBT-I into HF settings. Copyright © 2017 Elsevier Inc. All rights reserved.

Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial

PubMed Central

Manfredini, Fabio; Mallamaci, Francesca; D’Arrigo, Graziella; Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Lamberti, Nicola; Bertoli, Silvio; Ciurlino, Daniele; Rocca-Rey, Lisa; Barillà, Antonio; Battaglia, Yuri; Rapanà, Renato Mario; Zuccalà, Alessandro; Bonanno, Graziella; Fatuzzo, Pasquale; Rapisarda, Francesco; Rastelli, Stefania; Fabrizi, Fabrizio; Messa, Piergiorgio; De Paola, Luciano; Lombardi, Luigi; Cupisti, Adamasco; Fuiano, Giorgio; Lucisano, Gaetano; Summaria, Chiara; Felisatti, Michele; Pozzato, Enrico; Malagoni, Anna Maria; Castellino, Pietro; Aucella, Filippo; Abd ElHafeez, Samar; Provenzano, Pasquale Fabio; Tripepi, Giovanni; Catizone, Luigi

2017-01-01

Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n=145) or walking exercise (n=151); 227 patients (exercise n=104; control n=123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; P<0.001 between groups). Similarly, the five times sit-to-stand test time improved in the exercise group (mean time±SD: baseline, 20.5±6.0 seconds; 6 months, 18.2±5.7 seconds) but not in the control group (baseline, 20.9±5.8 seconds; 6 months, 20.2±6.4 seconds; P=0.001 between groups). The cognitive function score (P=0.04) and quality of social interaction score (P=0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis. PMID:27909047

Goal-directed Fluid Therapy Does Not Reduce Primary Postoperative Ileus after Elective Laparoscopic Colorectal Surgery: A Randomized Controlled Trial.

PubMed

Gómez-Izquierdo, Juan C; Trainito, Alessandro; Mirzakandov, David; Stein, Barry L; Liberman, Sender; Charlebois, Patrick; Pecorelli, Nicolò; Feldman, Liane S; Carli, Franco; Baldini, Gabriele

2017-07-01

Inadequate perioperative fluid therapy impairs gastrointestinal function. Studies primarily evaluating the impact of goal-directed fluid therapy on primary postoperative ileus are missing. The objective of this study was to determine whether goal-directed fluid therapy reduces the incidence of primary postoperative ileus after laparoscopic colorectal surgery within an Enhanced Recovery After Surgery program. Randomized patient and assessor-blind controlled trial conducted in adult patients undergoing laparoscopic colorectal surgery within an Enhanced Recovery After Surgery program. Patients were assigned randomly to receive intraoperative goal-directed fluid therapy (goal-directed fluid therapy group) or fluid therapy based on traditional principles (control group). Primary postoperative ileus was the primary outcome. One hundred twenty-eight patients were included and analyzed (goal-directed fluid therapy group: n = 64; control group: n = 64). The incidence of primary postoperative ileus was 22% in the goal-directed fluid therapy and 22% in the control group (relative risk, 1; 95% CI, 0.5 to 1.9; P = 1.00). Intraoperatively, patients in the goal-directed fluid therapy group received less intravenous fluids (mainly less crystalloids) but a greater volume of colloids. The increase of stroke volume and cardiac output was more pronounced and sustained in the goal-directed fluid therapy group. Length of hospital stay, 30-day postoperative morbidity, and mortality were not different. Intraoperative goal-directed fluid therapy compared with fluid therapy based on traditional principles does not reduce primary postoperative ileus in patients undergoing laparoscopic colorectal surgery in the context of an Enhanced Recovery After Surgery program. Its previously demonstrated benefits might have been offset by advancements in perioperative care.

Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial.

PubMed

Scheltens, Philip; Twisk, Jos W R; Blesa, Rafael; Scarpini, Elio; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Swinkels, Sophie H N; Stam, Cornelis J; de Waal, Hanneke; Wurtman, Richard J; Wieggers, Rico L; Vellas, Bruno; Kamphuis, Patrick J G H

2012-01-01

Souvenaid aims to improve synapse formation and function. An earlier study in patients with Alzheimer's disease (AD) showed that Souvenaid increased memory performance after 12 weeks in drug-naïve patients with mild AD. The Souvenir II study was a 24-week, randomized, controlled, double-blind, parallel-group, multi-country trial to confirm and extend previous findings in drug-naïve patients with mild AD. Patients were randomized 1:1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. The primary outcome was the memory function domain Z-score of the Neuropsychological Test Battery (NTB) over 24 weeks. Electroencephalography (EEG) measures served as secondary outcomes as marker for synaptic connectivity. Assessments were done at baseline, 12, and 24 weeks. The NTB memory domain Z-score was significantly increased in the active versus the control group over the 24-week intervention period (p = 0.023; Cohen's d = 0.21; 95% confidence interval [-0.06]-[0.49]). A trend for an effect was observed on the NTB total composite z-score (p = 0.053). EEG measures of functional connectivity in the delta band were significantly different between study groups during 24 weeks in favor of the active group. Compliance was very high (96.6% [control] and 97.1% [active]). No difference between study groups in the occurrence of (serious) adverse events. This study demonstrates that Souvenaid is well tolerated and improves memory performance in drug-naïve patients with mild AD. EEG outcomes suggest that Souvenaid has an effect on brain functional connectivity, supporting the underlying hypothesis of changed synaptic activity.

Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc

PubMed Central

Majd, Mohammed E.; Isaza, Jorge E.; Blumenthal, Scott L.; McAfee, Paul C.; Guyer, Richard D.; Hochschuler, Stephen H.; Geisler, Fred H.; Garcia, Rolando; Regan, John J.

2007-01-01

Background Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion. Methods In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charité group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages). Inclusion criteria included confirmed single-level degenerative disc disease at L4-5 or L5-S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study. Results The rate of approach-related complications was 9.8% in the investigational group and 10.1% in the control group. The rate of major neurological complications was similar between the 2 groups (investigational = 4.4%, control = 4.0%). There was a higher rate of superficial wound infection in the investigational group but no deep wound infections in either group. Pseudarthrosis occurred in 9.1% of control group patients. The rate of subsidence in the investigational group was 3.4%. The reoperation rate was 5.4% in the investigational group and 9.1% in the control group. Conclusions The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study. PMID:25802575

Direct versus indirect and individual versus group modes of language therapy for children with primary language impairment: principal outcomes from a randomized controlled trial and economic evaluation.

PubMed

Boyle, James M; McCartney, Elspeth; O'Hare, Anne; Forbes, John

2009-01-01

Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and each delivery mode offered to children individually or in groups. To investigate the relative effectiveness of indirect and direct intervention therapy modes delivered individually or in groups for children with primary language impairment. A multi-centre randomized controlled trial investigated 161 children with primary language impairment aged 6-11 years randomized to a usual-therapy control group or to direct individual, indirect individual, direct group or indirect group therapy modes. Intervention was delivered three times a week for 30-40-min sessions in mainstream schools over 15 weeks. Language performance was assessed at baseline, post-therapy and at 12 months. Cost analysis was based on salary and travel costs for intervention modes and usual therapy. Compared with controls, children receiving project therapy made short-term improvements in expressive (p = 0.031), but not receptive, language immediately following intervention. Children with specific expressive language delay were more likely to show improvement than those with mixed receptive-expressive difficulties. The four project therapy modes did not differ on primary language outcomes (all p-values>0.392) and there were no further improvements evident at follow-up. Indirect group therapy was the least costly mode, with direct individual therapy the most costly. Intervention in this age group can be effective for expressive language and can be delivered equally effectively though speech and language therapy assistants and to children in groups.

Effects of selenium on short-term control of hyperthyroidism due to Graves' disease treated with methimazole: results of a randomized clinical trial.

PubMed

Leo, M; Bartalena, L; Rotondo Dottore, G; Piantanida, E; Premoli, P; Ionni, I; Di Cera, M; Masiello, E; Sassi, L; Tanda, M L; Latrofa, F; Vitti, P; Marcocci, C; Marinò, M

2017-03-01

In spite of previous conflicting results, an adjuvant role of selenium in the treatment of Graves' disease (GD) hyperthyroidism has been proposed. To address this issue, a randomized clinical trial was carried out aimed at investigating whether selenium is beneficial on the short-term control of GD hyperthyroidism treated with methimazole (MMI). Thirty newly diagnosed hyperthyroid GD patients were randomly assigned to treatment with: (i) MMI or (ii) MMI plus selenium. Primary outcomes were: control of hyperthyroidism and clinical and biochemical manifestations of hyperthyroidism [heart rate, cholesterol, sex hormone-binding globulin (SHBG), hyperthyroidism symptoms] at 90 days. Baseline features of the two groups did not differ. Serum selenium at baseline was similar in the two groups and within the recommended range to define selenium sufficiency. Selenium increased with treatment in the MMI-selenium group and became significantly higher than in the MMI group. Serum malondialdehyde, a marker of oxidative stress, was similar in the two groups and decreased significantly with treatment, with no difference between groups. Administration of MMI was followed by a reduction of FT 3 and FT 4 , with no difference between groups. Heart rate, SHBG and symptoms of hyperthyroidism decreased, whereas total cholesterol increased in both groups with no difference between groups. Our study, carried out in a selenium-sufficient cohort of GD patients, failed to show an adjuvant role of selenium in the short-term control of hyperthyroidism. However, selenium might be beneficial in patients from selenium-deficient areas, as well as in the long-term outcome of antithyroid treatment.

Randomized controlled trial of attention bias modification in a racially diverse, socially anxious, alcohol dependent sample.

PubMed

Clerkin, Elise M; Magee, Joshua C; Wells, Tony T; Beard, Courtney; Barnett, Nancy P

2016-12-01

Attention biases may be an important treatment target for both alcohol dependence and social anxiety. This is the first ABM trial to investigate two (vs. one) targets of attention bias within a sample with co-occurring symptoms of social anxiety and alcohol dependence. Additionally, we used trial-level bias scores (TL-BS) to capture the phenomena of attention bias in a more ecologically valid, dynamic way compared to traditional attention bias scores. Adult participants (N = 86; 41% Female; 52% African American; 40% White) with elevated social anxiety symptoms and alcohol dependence were randomly assigned to an 8-session training condition in this 2 (Social Anxiety ABM vs. Social Anxiety Control) by 2 (Alcohol ABM vs. Alcohol Control) design. Symptoms of social anxiety, alcohol dependence, and attention bias were assessed across time. Multilevel models estimated the trajectories for each measure within individuals, and tested whether these trajectories differed according to the randomized training conditions. Across time, there were significant or trending decreases in all attention TL-BS parameters (but not traditional attention bias scores) and most symptom measures. However, there were not significant differences in the trajectories of change between any ABM and control conditions for any symptom measures. These findings add to previous evidence questioning the robustness of ABM and point to the need to extend the effects of ABM to samples that are racially diverse and/or have co-occurring psychopathology. The results also illustrate the potential importance of calculating trial-level attention bias scores rather than only including traditional bias scores. Copyright © 2016 Elsevier Ltd. All rights reserved.

Randomized Controlled Trial of Attention Bias Modification in a Racially Diverse, Socially Anxious, Alcohol Dependent Sample

PubMed Central

Clerkin, Elise M.; Magee, Joshua C.; Wells, Tony T.; Beard, Courtney; Barnett, Nancy P.

2016-01-01

Objective Attention biases may be an important treatment target for both alcohol dependence and social anxiety. This is the first ABM trial to investigate two (vs. one) targets of attention bias within a sample with co-occurring symptoms of social anxiety and alcohol dependence. Additionally, we used trial-level bias scores (TL-BS) to capture the phenomena of attention bias in a more ecologically valid, dynamic way compared to traditional attention bias scores. Method Adult participants (N=86; 41% Female; 52% African American; 40% White) with elevated social anxiety symptoms and alcohol dependence were randomly assigned to an 8-session training condition in this 2 (Social Anxiety ABM vs. Social Anxiety Control) by 2 (Alcohol ABM vs. Alcohol Control) design. Symptoms of social anxiety, alcohol dependence, and attention bias were assessed across time. Results Multilevel models estimated the trajectories for each measure within individuals, and tested whether these trajectories differed according to the randomized training conditions. Across time, there were significant or trending decreases in all attention TL-BS parameters (but not traditional attention bias scores) and most symptom measures. However, there were not significant differences in the trajectories of change between any ABM and control conditions for any symptom measures. Conclusions These findings add to previous evidence questioning the robustness of ABM and point to the need to extend the effects of ABM to samples that are racially diverse and/or have co-occurring psychopathology. The results also illustrate the potential importance of calculating trial-level attention bias scores rather than only including traditional bias scores. PMID:27591918

Chronic graft-versus-host disease: long-term results from a randomized trial on graft-versus-host disease prophylaxis with or without anti-T-cell globulin ATG-Fresenius.

PubMed

Socié, Gérard; Schmoor, Claudia; Bethge, Wolfgang A; Ottinger, Hellmut D; Stelljes, Matthias; Zander, Axel R; Volin, Liisa; Ruutu, Tapani; Heim, Dominik A; Schwerdtfeger, Rainer; Kolbe, Karin; Mayer, Jiri; Maertens, Johan A; Linkesch, Werner; Holler, Ernst; Koza, Vladimir; Bornhäuser, Martin; Einsele, Hermann; Kolb, Hans-Jochem; Bertz, Hartmut; Egger, Matthias; Grishina, Olga; Finke, Jürgen

2011-06-09

Previous randomized graft-versus-host disease (GVHD)-prophylaxis trials have failed to demonstrate reduced incidence and severity of chronic GVHD (cGVHD). Here we reanalyzed and updated a randomized phase 3 trial comparing standard GVHD prophylaxis with or without pretransplantation ATG-Fresenius (ATG-F) in 201 adult patients receiving myeloablative conditioning before transplantation from unrelated donors. The cumulative incidence of extensive cGVHD after 3 years was 12.2% in the ATG-F group versus 45.0% in the control group (P < .0001). The 3-year cumulative incidence of relapse and of nonrelapse mortality was 32.6% and 19.4% in the ATG-F group and 28.2% and 33.5% in the control group (hazard ratio [HR] = 1.21, P = .47, and HR = 0.68, P = .18), respectively. This nonsignificant reduction in nonrelapse mortality without increased relapse risk led to an overall survival rate after 3 years of 55.2% in the ATG-F group and 43.3% in the control group (HR = 0.84, P = .39, nonsignificant). The HR for receiving immunosuppressive therapy (IST) was 0.31 after ATG-F (P < .0001), and the 3-year probability of survival free of IST was 52.9% and 16.9% in the ATG-F versus control, respectively. The addition of ATG-F to standard cyclosporine, methotrexate GVHD prophylaxis lowers the incidence and severity of cGVHD, and the risk of receiving IST without raising the relapse rate. ATG-F prophylaxis reduces cGVHD morbidity.

The variability of software scoring of the CDMAM phantom associated with a limited number of images

NASA Astrophysics Data System (ADS)

Yang, Chang-Ying J.; Van Metter, Richard

2007-03-01

Software scoring approaches provide an attractive alternative to human evaluation of CDMAM images from digital mammography systems, particularly for annual quality control testing as recommended by the European Protocol for the Quality Control of the Physical and Technical Aspects of Mammography Screening (EPQCM). Methods for correlating CDCOM-based results with human observer performance have been proposed. A common feature of all methods is the use of a small number (at most eight) of CDMAM images to evaluate the system. This study focuses on the potential variability in the estimated system performance that is associated with these methods. Sets of 36 CDMAM images were acquired under carefully controlled conditions from three different digital mammography systems. The threshold visibility thickness (TVT) for each disk diameter was determined using previously reported post-analysis methods from the CDCOM scorings for a randomly selected group of eight images for one measurement trial. This random selection process was repeated 3000 times to estimate the variability in the resulting TVT values for each disk diameter. The results from using different post-analysis methods, different random selection strategies and different digital systems were compared. Additional variability of the 0.1 mm disk diameter was explored by comparing the results from two different image data sets acquired under the same conditions from the same system. The magnitude and the type of error estimated for experimental data was explained through modeling. The modeled results also suggest a limitation in the current phantom design for the 0.1 mm diameter disks. Through modeling, it was also found that, because of the binomial statistic nature of the CDMAM test, the true variability of the test could be underestimated by the commonly used method of random re-sampling.

Genetically predicted milk consumption and bone health, ischemic heart disease and type 2 diabetes: a Mendelian randomization study.

PubMed

Yang, Q; Lin, S L; Au Yeung, S L; Kwok, M K; Xu, L; Leung, G M; Schooling, C M

2017-08-01

Milk provides protein and micronutrients, and is recommended by some dietary guidelines, particularly for bone health. Meta-analysis of small randomized controlled trials suggests that milk may increase bone mineral density, but they are very heterogeneous. No randomized controlled trial has assessed the effects of milk on major chronic diseases. Previous Mendelian randomization studies of milk did not consider bone health, found no effects on ischemic heart disease (IHD) or type 2 diabetes (T2D) but higher body mass index. Using larger genetic studies, we estimated the effects of milk on osteoporosis, IHD, T2D, adiposity, lipids and glycemic traits. Instrumental variable analysis based on a genetic variant endowing lactase persistence (rs4988235 (MCM6)) was used to obtain estimates for osteoporosis (GEFOS), IHD (CARDIoGRAMplusC4D), T2D (DIAGRAM), adiposity (GIANT), lipids (GLGC) and glycaemic traits (MAGIC). Eye color was a negative control for IHD, as it mirrors the distribution of lactase persistence and IHD in Western Europe. Genetically predicted adult milk consumption was not clearly associated with bone mineral density, IHD (odds ratio (OR): 1.03 per s.d., 95% confidence interval (CI): 0.95-1.12) and or T2D (OR: 0.92, 95% CI: 0.83-1.02) but was associated with higher log-transformed fasting insulin (0.05, 95% CI: 0.02-0.07) and body mass index (0.06, 95% CI: 0.03-0.09). Genetically predicted eye color was not associated with IHD. The lack of association of genetically predicted milk consumption with bone health, IHD or T2D suggests few beneficial effects but is more consistent with milk promoting adiposity.

Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials.

PubMed

Gerson, Lauren; Stouch, Bruce; Lobonţiu, Adrian

2018-01-01

The TIF procedure has emerged as an endoscopic treatment for patients with refractory gastro-esophageal reflux disease (GERD). Previous systematic reviews of the TIF procedure conflated findings from studies with modalities that do not reflect the current 2.0 procedure technique or refined data-backed patient selection criteria. A meta-analysis was conducted using data only from randomized studies that assessed the TIF 2.0 procedure compared to a control. The purpose of the meta-analysis was to determine the efficacy and long-term outcomes associated with performance of the TIF 2.0 procedure in patients with chronic long-term refractory GERD on optimized PPI therapy, including esophageal pH, PPI utilization and quality of life. Methods: Three prospective research questions were predicated on the outcomes of the TIF procedure compared to patients who received PPI therapy or sham, concomitant treatment for GERD, and the patient-reported quality of life. Event rates were calculated using the random effect model. Since the time of follow-up post-TIF procedure was variable, analysis was performed to incorporate the time of follow-up for each individual patient at the 3-year time point. Results: Results from this meta-analysis, including data from 233 patients, demonstrated that TIF subjects at 3 years had improved esophageal pH, a decrease in PPI utilization, and improved quality of life. Conclusions: In a meta-analysis of randomized, controlled trials (RCTs), the TIF procedure data for patients with GERD refractory to PPI's produces significant changes, compared with sham or PPI therapy, in esophageal pH, decreased PPI utilization, and improved quality of life. Celsius.

Heavy Slow Resistance Versus Eccentric Training as Treatment for Achilles Tendinopathy: A Randomized Controlled Trial.

PubMed

Beyer, Rikke; Kongsgaard, Mads; Hougs Kjær, Birgitte; Øhlenschlæger, Tommy; Kjær, Michael; Magnusson, S Peter

2015-07-01

Previous studies have shown that eccentric training has a positive effect on Achilles tendinopathy, but few randomized controlled trials have compared it with other loading-based treatment regimens. To evaluate the effectiveness of eccentric training (ECC) and heavy slow resistance training (HSR) among patients with midportion Achilles tendinopathy. Randomized controlled trial; Level of evidence, 1. A total of 58 patients with chronic (>3 months) midportion Achilles tendinopathy were randomized to ECC or HSR for 12 weeks. Function and symptoms (Victorian Institute of Sports Assessment-Achilles), tendon pain during activity (visual analog scale), tendon swelling, tendon neovascularization, and treatment satisfaction were assessed at 0 and 12 weeks and at the 52-week follow-up. Analyses were performed on an intention-to-treat basis. Both groups showed significant (P < .0001) improvements in Victorian Institute of Sports Assessment-Achilles and visual analog scale from 0 to 12 weeks, and these improvements were maintained at the 52-week follow-up. Concomitant with the clinical improvement, there was a significant reduction in tendon thickness and neovascularization. None of these robust clinical and structural improvements differed between the ECC and HSR groups. However, patient satisfaction tended to be greater after 12 weeks with HSR (100%) than with ECC (80%; P = .052) but not after 52 weeks (HSR, 96%; ECC, 76%; P = .10), and the mean training session compliance rate was 78% in the ECC group and 92% in the HSR group, with a significant difference between groups (P < .005). The results of this study show that both traditional ECC and HSR yield positive, equally good, lasting clinical results in patients with Achilles tendinopathy and that the latter tends to be associated with greater patient satisfaction after 12 weeks but not after 52 weeks. © 2015 The Author(s).

Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial Injury after Noncardiac Surgery (MANAGE).

PubMed

Duceppe, Emmanuelle; Yusuf, Salim; Tandon, Vikas; Rodseth, Reitze; Biccard, Bruce M; Xavier, Denis; Szczeklik, Wojciech; Meyhoff, Christian S; Franzosi, Maria Grazia; Vincent, Jessica; Srinathan, Sadeesh K; Parlow, Joel; Magloire, Patrick; Neary, John; Rao, Mangala; Chaudhry, Navneet K; Mayosi, Bongani; de Nadal, Miriam; Popova, Ekaterine; Villar, Juan Carlos; Botto, Fernando; Berwanger, Otavio; Guyatt, Gordon; Eikelboom, John W; Sessler, Daniel I; Kearon, Clive; Pettit, Shirley; Connolly, Stuart J; Sharma, Mukul; Bangdiwala, Shrikant I; Devereaux, P J

2018-03-01

Worldwide approximately 200 million adults undergo major surgery annually, of whom 8 million are estimated to suffer a myocardial injury after noncardiac surgery (MINS). There is currently no trial data informing the management of MINS. Antithrombotic agents such as direct oral anticoagulants might prevent major vascular complications in patients with MINS. The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial is a large international blinded randomized controlled trial of dabigatran vs placebo in patients who suffered MINS. We used a partial factorial design to also determine the effect of omeprazole vs placebo in reducing upper gastrointestinal bleeding and complications. Both study drugs were initiated in eligible patients within 35 days of suffering MINS and continued for a maximum of 2 years. The primary outcome is a composite of major vascular complications for the dabigatran trial and a composite of upper gastrointestinal complications for the omeprazole trial. We present the rationale and design of the trial and baseline characteristics of enrolled patients. The trial randomized 1754 patients between January 2013 and July 2017. Patients' mean age was 69.9 years, 51.1% were male, 14.3% had a history of peripheral artery disease, 6.6% had a history of stroke or transient ischemic attack, 12.9% had a previous myocardial infarction, and 26.0% had diabetes. The diagnosis of MINS was on the basis of an isolated ischemic troponin elevation in 80.4% of participants. MANAGE is the first randomized controlled trial to evaluate a potential treatment of patients who suffered MINS. Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

A randomized double-blind, placebo-controlled trial of minocycline in children and adolescents with fragile x syndrome.

PubMed

Leigh, Mary Jacena S; Nguyen, Danh V; Mu, Yi; Winarni, Tri I; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M; Hessl, David; Hagerman, Randi J

2013-04-01

Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Previous open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, aged 3.5 years to 16 years (n = 55, mean age 9.2 [SD, 3.6] years). Participants were randomized to minocycline or placebo for 3 months and then switched to the other treatment. Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared with placebo (2.49 ± 0.13 and 2.97 ± 0.13, respectively, p = .0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analog Scale (minocycline: 5.26 cm ± 0.46 cm, placebo: 4.05 cm ± 0.46 cm; p = .0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding, and preliminary efficacy analysis results known to investigators. Minocycline treatment for 3 months in children with FXS resulted in greater global improvement than placebo. Treatment for 3 months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline.

STAR 3 randomized controlled trial to compare sensor-augmented insulin pump therapy with multiple daily injections in the treatment of type 1 diabetes: research design, methods, and baseline characteristics of enrolled subjects.

PubMed

Davis, Stephen N; Horton, Edward S; Battelino, Tadej; Rubin, Richard R; Schulman, Kevin A; Tamborlane, William V

2010-04-01

Sensor-augmented pump therapy (SAPT) integrates real-time continuous glucose monitoring (RT-CGM) with continuous subcutaneous insulin infusion (CSII) and offers an alternative to multiple daily injections (MDI). Previous studies provide evidence that SAPT may improve clinical outcomes among people with type 1 diabetes. Sensor-Augmented Pump Therapy for A1c Reduction (STAR) 3 is a multicenter randomized controlled trial comparing the efficacy of SAPT to that of MDI in subjects with type 1 diabetes. Subjects were randomized to either continue with MDI or transition to SAPT for 1 year. Subjects in the MDI cohort were allowed to transition to SAPT for 6 months after completion of the study. SAPT subjects who completed the study were also allowed to continue for 6 months. The primary end point was the difference between treatment groups in change in hemoglobin A1c (HbA1c) percentage from baseline to 1 year of treatment. Secondary end points included percentage of subjects with HbA1c < or =7% and without severe hypoglycemia, as well as area under the curve of time spent in normal glycemic ranges. Tertiary end points include percentage of subjects with HbA1c < or =7%, key safety end points, user satisfaction, and responses on standardized assessments. A total of 495 subjects were enrolled, and the baseline characteristics similar between the SAPT and MDI groups. Study completion is anticipated in June 2010. Results of this randomized controlled trial should help establish whether an integrated RT-CGM and CSII system benefits patients with type 1 diabetes more than MDI.

Adaptive Designs for Randomized Trials in Public Health

PubMed Central

Brown, C. Hendricks; Have, Thomas R. Ten; Jo, Booil; Dagne, Getachew; Wyman, Peter A.; Muthén, Bengt; Gibbons, Robert D.

2009-01-01

In this article, we present a discussion of two general ways in which the traditional randomized trial can be modified or adapted in response to the data being collected. We use the term adaptive design to refer to a trial in which characteristics of the study itself, such as the proportion assigned to active intervention versus control, change during the trial in response to data being collected. The term adaptive sequence of trials refers to a decision-making process that fundamentally informs the conceptualization and conduct of each new trial with the results of previous trials. Our discussion below investigates the utility of these two types of adaptations for public health evaluations. Examples are provided to illustrate how adaptation can be used in practice. From these case studies, we discuss whether such evaluations can or should be analyzed as if they were formal randomized trials, and we discuss practical as well as ethical issues arising in the conduct of these new-generation trials. PMID:19296774

Laser backscattered from partially convex targets of large sizes in random media for E-wave polarization.

PubMed

El-Ocla, Hosam

2006-08-01

The characteristics of a radar cross section (RCS) of partially convex targets with large sizes up to five wavelengths in free space and random media are studied. The nature of the incident wave is an important factor in remote sensing and radar detection applications. I investigate the effects of beam wave incidence on the performance of RCS, drawing on the method I used in a previous study on plane-wave incidence. A beam wave can be considered a plane wave if the target size is smaller than the beam width. Therefore, to have a beam wave with a limited spot on the target, the target size should be larger than the beam width (assuming E-wave incidence wave polarization. The effects of the target configuration, random medium parameters, and the beam width on the laser RCS and the enhancement in the radar cross section are numerically analyzed, resulting in the possibility of having some sort of control over radar detection using beam wave incidence.

Fluid Physics Under a Stochastic Acceleration Field

NASA Technical Reports Server (NTRS)

Vinals, Jorge

2001-01-01

The research summarized in this report has involved a combined theoretical and computational study of fluid flow that results from the random acceleration environment present onboard space orbiters, also known as g-jitter. We have focused on a statistical description of the observed g-jitter, on the flows that such an acceleration field can induce in a number of experimental configurations of interest, and on extending previously developed methodology to boundary layer flows. Narrow band noise has been shown to describe many of the features of acceleration data collected during space missions. The scale of baroclinically induced flows when the driving acceleration is random is not given by the Rayleigh number. Spatially uniform g-jitter induces additional hydrodynamic forces among suspended particles in incompressible fluids. Stochastic modulation of the control parameter shifts the location of the onset of an oscillatory instability. Random vibration of solid boundaries leads to separation of boundary layers. Steady streaming ahead of a modulated solid-melt interface enhances solute transport, and modifies the stability boundaries of a planar front.

Evaluation of App-Based Serious Gaming as a Training Method in Teaching Chest Tube Insertion to Medical Students: Randomized Controlled Trial

PubMed Central

Ober, Julian; Walker, Tilman; Bergdolt, Christian; Friedrich, Mirco; Müller-Stich, Beat Peter; Forchheim, Franziska; Fischer, Christian; Schmidmaier, Gerhard; Tanner, Michael C

2018-01-01

Background The insertion of a chest tube should be as quick and accurate as possible to maximize the benefit and minimize possible complications for the patient. Therefore, comprehensive training and assessment before an emergency situation are essential for proficiency in chest tube insertion. Serious games have become more prevalent in surgical training because they enable students to study and train a procedure independently, and errors made have no effect on patients. However, up-to-date evidence regarding the effect of serious games on performance in procedures in emergency medicine remains scarce. Objective The aim of this study was to investigate the serious gaming approach in teaching medical students an emergency procedure (chest tube insertion) using the app Touch Surgery and a modified objective structural assessment of technical skills (OSATS). Methods In a prospective, rater-blinded, randomized controlled trial, medical students were randomized into two groups: intervention group or control group. Touch Surgery has been established as an innovative and cost-free app for mobile devices. The fully automatic software enables users to train medical procedures and afterwards self-assess their training effort. The module chest tube insertion teaches each key step in the insertion of a chest tube and enables users the meticulous application of a chest tube. In contrast, the module “Thoracocentesis” discusses a basic thoracocentesis. All students attended a lecture regarding chest tube insertion (regular curriculum) and afterwards received a Touch Surgery training lesson: intervention group used the module chest tube insertion and the control group used Thoracocentesis as control training. Participants’ performance in chest tube insertion on a porcine model was rated on-site via blinded face-to-face rating and via video recordings using a modified OSATS tool. Afterwards, every participant received an individual questionnaire for self-evaluation. Here, trainees gave information about their individual training level, as well as previous experiences, gender, and hobbies. Primary end point was operative performance during chest tube insertion by direct observance. Results A total of 183 students enrolled, 116 students participated (63.4%), and 21 were excluded because of previous experiences in chest tube insertion. Students were randomized to the intervention group (49/95, 52%) and control group (46/95, 48%). The intervention group performed significantly better than the control group (Intervention group: 38.0 [I50=7.0] points; control group: 30.5 [I50=8.0] points; P<.001). The intervention group showed significantly improved economy of time and motion (P=.004), needed significantly less help (P<.001), and was more confident in handling of instruments (P<.001) than the control group. Conclusions The results from this study show that serious games are a valid and effective tool in education of operative performance in chest tube insertion. We believe that serious games should be implemented in the surgical curriculum, as well as residency programs, in addition to traditional learning methods. Trial Registration German Clinical Trials Register (DRKS) DRKS00009994; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00009994 (Archived by Webcite at http://www.webcitation.org/6ytWF1CWg) PMID:29784634

Multifamily psychoeducation for improvement of mental health among relatives of patients with major depressive disorder lasting more than one year: study protocol for a randomized controlled trial.

PubMed

Katsuki, Fujika; Takeuchi, Hiroshi; Watanabe, Norio; Shiraishi, Nao; Maeda, Tohru; Kubota, Yosuke; Suzuki, Masako; Yamada, Atsurou; Akechi, Tatsuo

2014-08-12

Major depressive disorder (MDD) is a long-lasting disorder with frequent relapses that have significant effects on the patient's family. Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder. A previous randomized controlled trial has found that family psychoeducation is effective in enhancing the treatment of MDD. Although MDD can easily become a chronic illness, there has been no intervention study on the families of patients with chronic depression. In the present study, we design a randomized controlled trial to examine the effectiveness of family psychoeducation in improving the mental health of relatives of patients with MDD lasting more than one year. Participants are patients with MDD lasting more than one year and their relatives. Individually randomized, parallel-group trial design will be employed. Participants will be allocated to one of two treatment conditions: relatives will receive (a) family psychoeducation (four, two-hour biweekly multifamily psychoeducation sessions) plus treatment-as-usual for the patient (consultation by physicians), or (b) counseling for the family (one counseling session from a nurse) plus treatment-as-usual for the patient. The primary outcome measure will be relatives' mental health as measured by K6 that was developed to screen for DSM-IV depressive and anxiety disorder. Additionally, the severity of depressive symptoms in patients measured by the Beck Depression Inventory-II (BDI-II) scale will be assessed. Data from the intention-to-treat sample will be analyzed 16 weeks after randomization. This is the first study to evaluate the effectiveness of family psychoeducation for relatives of patients with MDD lasting more than one year. If this type of intervention is effective, it could be a new method of rehabilitation for patients with MDD lasting more than one year. Clinical Trials.gov NCT01734291 (registration date: 18 October 2012).

Incentive Spirometry after Lung Resection: A Randomized Controlled Trial.

PubMed

Malik, Peter Ra; Fahim, Christine; Vernon, Jordyn; Thomas, Priya; Schieman, Colin; Finley, Christian J; Agzarian, John; Shargall, Yaron; Farrokhyar, Forough; Hanna, Wael C

2018-04-24

Incentive spirometry (IS) is thought to reduce the incidence of postoperative pulmonary complications (PPC) after lung resection. We sought to determine whether the addition of IS to routine physiotherapy following lung resection results in a lower rate of PPC, as compared to physiotherapy alone. A single-blind prospective randomized controlled trial was conducted in adults undergoing lung resection. Individuals with previous lung surgery or home oxygen were excluded. Participants randomized to the control arm (PHY) received routine physiotherapy alone (deep breathing, ambulation and shoulder exercises). Those randomized to the intervention arm (PHY/IS) received IS in addition to routine physiotherapy. The trial was powered to detect a 10% difference in the rate of PPC (beta=80%). Student's t-test and chi-square were utilized for continuous and categorical variables respectively, with a significance level of p=0.05. A total of 387 participants (n=195 PHY/IS; n=192 PHY) were randomized between 2014-2017. Baseline characteristics were comparable for both arms. The majority of patients underwent a pulmonary lobectomy (PHY/IS=59.5%, PHY=61.0%, p=0.84), with no difference in the rates of minimally invasive and open procedures. There were no differences in the incidence of PPC at 30 days postoperatively (PHY/IS=12.3%, PHY=13.0%, p=0.88). There were no differences in rates of pneumonia (PHY/IS=4.6%, PHY=7.8%, p=0.21), mechanical ventilation (PHY/IS=2.1%, PHY=1.0%, p=0.41), home-oxygen (PHY/IS=13.8%, PHY=14.6%, p=0.89), hospital length of stay (PHY/IS=4 days, PHY=4 days, p=0.34), or rate of readmission to hospital (PHY/IS=10.3%, PH=9.9%, p=1.00). The addition of IS to routine postoperative physiotherapy does not reduce the incidence of PPC after lung resection. Copyright © 2018. Published by Elsevier Inc.

The effects of training by virtual reality or gym ball on pelvic floor muscle strength in postmenopausal women: a randomized controlled trial.

PubMed

Martinho, Natalia M; Silva, Valéria R; Marques, Joseane; Carvalho, Leonardo C; Iunes, Denise H; Botelho, Simone

2016-03-22

To evaluate the effectiveness of abdominopelvic training by virtual reality compared to pelvic floor muscle training (PFMT) using a gym ball (a previously tested and efficient protocol) on postmenopausal women's pelvic floor muscle (PFM) strength. A randomized controlled trial was conducted with 60 postmenopausal women, randomly allocated into two groups: Abdominopelvic training by virtual reality - APT_VR (n=30) and PFMT using a gym ball - PFMT_GB (n=30). Both types of training were supervised by the same physical therapist, during 10 sessions each, for 30 minutes. The participants' PFM strength was evaluated by digital palpation and vaginal dynamometry, considering three different parameters: maximum strength, average strength and endurance. An intention-to-treat approach was used to analyze the participants according to original groups. No significant between-group differences were observed in most analyzed parameters. The outcome endurance was higher in the APT_VR group (p=0.003; effect size=0.89; mean difference=1.37; 95% CI=0.46 to 2.28). Both protocols have improved the overall PFM strength, suggesting that both are equally beneficial and can be used in clinical practice. Muscle endurance was higher in patients who trained using virtual reality.

The effects of training by virtual reality or gym ball on pelvic floor muscle strength in postmenopausal women: a randomized controlled trial

PubMed Central

Martinho, Natalia M.; Silva, Valéria R.; Marques, Joseane; Carvalho, Leonardo C.; Iunes, Denise H.; Botelho, Simone

2016-01-01

ABSTRACT Objective To evaluate the effectiveness of abdominopelvic training by virtual reality compared to pelvic floor muscle training (PFMT) using a gym ball (a previously tested and efficient protocol) on postmenopausal women’s pelvic floor muscle (PFM) strength. Method A randomized controlled trial was conducted with 60 postmenopausal women, randomly allocated into two groups: Abdominopelvic training by virtual reality – APT_VR (n=30) and PFMT using a gym ball – PFMT_GB (n=30). Both types of training were supervised by the same physical therapist, during 10 sessions each, for 30 minutes. The participants’ PFM strength was evaluated by digital palpation and vaginal dynamometry, considering three different parameters: maximum strength, average strength and endurance. An intention-to-treat approach was used to analyze the participants according to original groups. Results No significant between-group differences were observed in most analyzed parameters. The outcome endurance was higher in the APT_VR group (p=0.003; effect size=0.89; mean difference=1.37; 95% CI=0.46 to 2.28). Conclusion Both protocols have improved the overall PFM strength, suggesting that both are equally beneficial and can be used in clinical practice. Muscle endurance was higher in patients who trained using virtual reality. PMID:27437716

Mental skills training with basic combat training soldiers: A group-randomized trial.

PubMed

Adler, Amy B; Bliese, Paul D; Pickering, Michael A; Hammermeister, Jon; Williams, Jason; Harada, Coreen; Csoka, Louis; Holliday, Bernie; Ohlson, Carl

2015-11-01

Cognitive skills training has been linked to greater skills, self-efficacy, and performance. Although research in a variety of organizational settings has demonstrated training efficacy, few studies have assessed cognitive skills training using rigorous, longitudinal, randomized trials with active controls. The present study examined cognitive skills training in a high-risk occupation by randomizing 48 platoons (N = 2,432 soldiers) in basic combat training to either (a) mental skills training or (b) an active comparison condition (military history). Surveys were conducted at baseline and 3 times across the 10-week course. Multilevel mixed-effects models revealed that soldiers in the mental skills training condition reported greater use of a range of cognitive skills and increased confidence relative to those in the control condition. Soldiers in the mental skills training condition also performed better on obstacle course events, rappelling, physical fitness, and initial weapons qualification scores, although effects were generally moderated by gender and previous experience. Overall, effects were small; however, given the rigor of the design, the findings clearly contribute to the broader literature by providing supporting evidence that cognitive training skills can enhance performance in occupational and sports settings. Future research should address gender and experience to determine the need for targeting such training appropriately. (c) 2015 APA, all rights reserved).

Effects of Aloe Sterol Supplementation on Skin Elasticity, Hydration, and Collagen Score: A 12-Week Double-Blind, Randomized, Controlled Trial.

PubMed

Tanaka, Miyuki; Yamamoto, Yuki; Misawa, Eriko; Nabeshima, Kazumi; Saito, Marie; Yamauchi, Koji; Abe, Fumiaki; Furukawa, Fukumi

2016-01-01

Our previous study confirmed that Aloe sterol stimulates collagen and hyaluronic acid production in human dermal fibroblasts. This study aims to investigate whether Aloe sterol intake affects skin conditions. We performed a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of oral Aloe sterol supplementation on skin elasticity, hydration, and the collagen score in 64 healthy women (age range 30-59 years; average 44.3 years) who were randomly assigned to receive either a placebo or an Aloe sterol-supplemented yogurt. Skin parameters were measured and ultrasound analysis of the forearm was performed. ANCOVA revealed statistical differences in skin moisture, transepidermal water loss, skin elasticity, and collagen score between the Aloe sterol and placebo groups. The gross elasticity (R2), net elasticity (R5), and biological elasticity (R7) scores of the Aloe sterol group significantly increased with time. In addition, skin fatigue area F3, which is known to decrease with age and fatigue, also increased with Aloe sterol intake. Ultrasound echogenicity revealed that the collagen content in the dermis increased with Aloe sterol intake. The results suggest that continued Aloe sterol ingestion contributes to maintaining healthy skin. © 2017 S. Karger AG, Basel.

Will reducing sugar-sweetened beverage consumption reduce obesity? Evidence supporting conjecture is strong, but evidence when testing effect is weak

PubMed Central

Kaiser, Kathryn A.; Shikany, James M.; Keating, Karen D.; Allison, David B.

2014-01-01

We provide arguments to the debate question and update a previous meta-analysis with recently published studies on effects of sugar-sweetened beverages (SSBs) on body weight/composition indices (BWIs). We abstracted data from randomized controlled trials examining effects of consumption of SSBs on BWIs. Six new studies met these criteria: 1) human trials, 2) 3 weeks duration, 3) random assignment to conditions differing only in consumption of SSBs, and 4) including a BWI outcome. Updated meta-analysis of a total of seven studies that added SSBs to persons’ diets showed dose-dependent increases in weight. Updated meta-analysis of eight studies attempting to reduce SSB consumption showed an equivocal effect on BWIs in all randomized subjects. When limited to subjects overweight at baseline, meta-analysis showed a significant effect of roughly 0.25 standard deviations (more weight loss/less weight gain) relative to controls. Evidence to date is equivocal in showing that decreasing SSB consumption will reduce the prevalence of obesity. Although new evidence suggests that an effect may yet be demonstrable in some populations, the integrated effect size estimate remains very small and of equivocal statistical significance. Problems in this research area and suggestions for future research are highlighted. PMID:23742715

Long-lasting changes in brain activation induced by a single REAC technology pulse in Wi-Fi bands. Randomized double-blind fMRI qualitative study.

PubMed

Rinaldi, Salvatore; Mura, Marco; Castagna, Alessandro; Fontani, Vania

2014-07-11

The aim of this randomized double-blind study was to evaluate in healthy adult subjects, with functional magnetic resonance imaging (fMRI), long lasting changes in brain activation patterns following administration of a single, 250 milliseconds pulse emitted with radio-electric asymmetric conveyer (REAC) technology in the Wi-Fi bands. The REAC impulse was not administered during the scan, but after this, according to a protocol that has previously been demonstrated to be effective in improving motor control and postural balance, in healthy subjects and patients. The study was conducted on 33 healthy volunteers, performed with a 1.5 T unit while operating a motor block task involving cyclical and alternating flexion and extension of one leg. Subsequently subjects were randomly divided into a treatment and a sham treatment control group. Repeated fMRI examinations were performed following the administration of the REAC pulse or sham treatment. The Treated group showed cerebellar and ponto-mesencephalic activation components that disappeared in the second scan, while these activation components persisted in the Sham group. This study shows that a very weak signal, such as 250 milliseconds Wi-Fi pulse, administered with REAC technology, could lead to lasting effects on brain activity modification.

Landscape and Residential Variables Associated with Plague-Endemic Villages in the West Nile Region of Uganda

PubMed Central

MacMillan, Katherine; Enscore, Russell E.; Ogen-Odoi, Asaph; Borchert, Jeff N.; Babi, Nackson; Amatre, Gerald; Atiku, Linda A.; Mead, Paul S.; Gage, Kenneth L.; Eisen, Rebecca J.

2011-01-01

Plague, caused by the bacteria Yersinia pestis, is a severe, often fatal disease. This study focuses on the plague-endemic West Nile region of Uganda, where limited information is available regarding environmental and behavioral risk factors associated with plague infection. We conducted observational surveys of 10 randomly selected huts within historically classified case and control villages (four each) two times during the dry season of 2006 (N = 78 case huts and N = 80 control huts), which immediately preceded a large plague outbreak. By coupling a previously published landscape-level statistical model of plague risk with this observational survey, we were able to identify potential residence-based risk factors for plague associated with huts within historic case or control villages (e.g., distance to neighboring homestead and presence of pigs near the home) and huts within areas previously predicted as elevated risk or low risk (e.g., corn and other annual crops grown near the home, water storage in the home, and processed commercial foods stored in the home). The identified variables are consistent with current ecologic theories on plague transmission dynamics. This preliminary study serves as a foundation for future case control studies in the area. PMID:21363983

Blinded randomized controlled study of a web-based otoscopy simulator in undergraduate medical education.

PubMed

Stepniak, Camilla; Wickens, Brandon; Husein, Murad; Paradis, Josee; Ladak, Hanif M; Fung, Kevin; Agrawal, Sumit K

2017-06-01

OtoTrain is a Web-based otoscopy simulator that has previously been shown to have face and content validity. The objective of this study was to evaluate the effectiveness of this Web-based otoscopy simulator in teaching diagnostic otoscopy to novice learners STUDY DESIGN: Prospective, blinded randomized control trial. Second-year medical students were invited to participate in the study. A pretest consisted of a series of otoscopy videos followed by an open-answer format assessment pertaining to the characteristics and diagnosis of each video. Participants were then randomly divided into a control group and a simulator group. Following the pretest, both groups attended standard otology lectures, but the simulator group was additionally given unlimited access to OtoTrain for 1 week. A post-test was completed using a separate set of otoscopy videos. Tests were graded based on a comprehensive marking scheme. The pretest and post-test were anonymized, and the three evaluators were blinded to student allotment. A total of 41 medical students were enrolled in the study and randomized to the control group (n = 20) and the simulator group (n = 21). There was no significant difference between the two groups on their pretest scores. With the standard otology lectures, the control group had a 31% improvement in their post-test score (mean ± standard error of the mean, 30.4 ± 1.5) compared with their pretest score (23.3 ± 1.8) (P < .001). The simulator group had the addition of OtoTrain to the otology lectures, and their score improved by 71% on their post-test (37.8 ± 1.6) compared to their pretest (22.1 ± 1.9) (P < .001). Comparing the post-test results, the simulator group had a 24% higher score than the control group (P < .002). Inter-rater reliability between the blinded evaluators was excellent (r = 0.953, P < .001). The use of OtoTrain increased the diagnostic otoscopic performance in novice learners. OtoTrain may be an effective teaching adjunct for undergraduate medical students. 1b. Laryngoscope, 127:1306-1311, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

The CHOLEGAS study: multicentric randomized, blinded, controlled trial of gastrectomy plus prophylactic cholecystectomy versus gastrectomy only, in adults submitted to gastric cancer surgery with curative intent.

PubMed

Farsi, Marco; Bernini, Marco; Bencini, Lapo; Miranda, Egidio; Manetti, Roberto; de Manzoni, Giovanni; Verlato, Giuseppe; Marrelli, Daniele; Pedrazzani, Corrado; Roviello, Francesco; Marchet, Alberto; Cristadoro, Luigi; Gerard, Leonardo; Moretti, Renato

2009-05-15

The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus nerve branches and the anatomical gastrointestinal reconstruction. Therefore, some surgeons perform routine concomitant cholecystectomy during standard surgery for gastric malignancies. However, not all the patients who are diagnosed to have cholelithiasis after gastric cancer surgery will develop symptoms or require additional surgical treatments and a standard laparoscopic cholecystectomy is feasible even in those patients who underwent previous gastric surgery. At the present, no randomized study has been published and the decision of gallbladder management is left to each surgeon preference. The study is a randomized controlled investigation. The study will be performed in the General and Oncologic Surgery, Department of Oncology-Azienda Ospedaliero-Universitaria Careggi-Florence-Italy, a large teaching institution, with the participation of all surgeons who accept to be involved in, together with other Italian Surgical Centers, on behalf of the GIRCG (Italian Research Group for Gastric Cancer).The patients will be randomized into two groups: in the first group the patient will be submitted to prophylactic cholecystectomy during standard surgery for curable gastric cancer (subtotal or total gastrectomy), while in the second group he/she will be submitted to standard gastric surgery only. ClinicalTrials.gov ID. NCT00757640.

Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial.

PubMed

Williams, Hywel C; Bath-Hextall, Fiona; Ozolins, Mara; Armstrong, Sarah J; Colver, Graham B; Perkins, William; Miller, Paul S J

2017-03-01

We previously reported modest clinical 3-year benefit for topical imiquimod compared with surgery for superficial or nodular basal cell carcinoma at low-risk sites in our noninferiority randomized controlled SINS trial. Here we report 5-year data. Participants were randomized to imiquimod 5% cream once daily (superficial basal cell carcinoma, 6 weeks; nodular basal cell carcinoma, 12 weeks) or excisional surgery (4-mm margin). The primary outcome was clinical absence of initial failure or signs of recurrence at the 3-year dermatology review. Five-year success was defined as 3-year success plus absence of recurrences identified through hospital, histopathology, and general practitioner records. Of 501 participants randomized, 401 contributed to the modified intention-to-treat analyses at year 3 (primary outcome), 383 (96%) of whom had data at year 5. Five-year success rates for imiquimod were 82.5% (170/206) compared with 97.7% (173/177) for surgery (relative risk of imiquimod success = 0.84, 95% confidence interval = 0.77-0.91, P < 0.001). These were comparable to year 3 success rates of 83.6% (178/213) and 98.4% (185/188) for imiquimod and surgery, respectively. Most imiquimod treatment failures occurred in year 1. Although surgery is clearly superior to imiquimod, this study shows sustained benefit for lesions that respond early to topical imiquimod. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Data Randomization and Cluster-Based Partitioning for Botnet Intrusion Detection.

PubMed

Al-Jarrah, Omar Y; Alhussein, Omar; Yoo, Paul D; Muhaidat, Sami; Taha, Kamal; Kim, Kwangjo

2016-08-01

Botnets, which consist of remotely controlled compromised machines called bots, provide a distributed platform for several threats against cyber world entities and enterprises. Intrusion detection system (IDS) provides an efficient countermeasure against botnets. It continually monitors and analyzes network traffic for potential vulnerabilities and possible existence of active attacks. A payload-inspection-based IDS (PI-IDS) identifies active intrusion attempts by inspecting transmission control protocol and user datagram protocol packet's payload and comparing it with previously seen attacks signatures. However, the PI-IDS abilities to detect intrusions might be incapacitated by packet encryption. Traffic-based IDS (T-IDS) alleviates the shortcomings of PI-IDS, as it does not inspect packet payload; however, it analyzes packet header to identify intrusions. As the network's traffic grows rapidly, not only the detection-rate is critical, but also the efficiency and the scalability of IDS become more significant. In this paper, we propose a state-of-the-art T-IDS built on a novel randomized data partitioned learning model (RDPLM), relying on a compact network feature set and feature selection techniques, simplified subspacing and a multiple randomized meta-learning technique. The proposed model has achieved 99.984% accuracy and 21.38 s training time on a well-known benchmark botnet dataset. Experiment results demonstrate that the proposed methodology outperforms other well-known machine-learning models used in the same detection task, namely, sequential minimal optimization, deep neural network, C4.5, reduced error pruning tree, and randomTree.

Community-based Randomized Controlled Trial of Non-pharmacological Interventions in Prevention and Control of Hypertension among Young Adults.

PubMed

Saptharishi, Lg; Soudarssanane, Mb; Thiruselvakumar, D; Navasakthi, D; Mathanraj, S; Karthigeyan, M; Sahai, A

2009-10-01

Hypertension is a major chronic lifestyle disease. Several non-pharmacological interventions are effective in bringing down the blood pressure (BP). This study focuses on the effectiveness of such interventions among young adults. To measure the efficacy of physical exercise, reduction in salt intake, and yoga, in lowering BP among young (20-25) pre-hypertensives and hypertensives, and to compare their relative efficacies. The study was done in the urban service area of JIPMER. Pre-hypertensives and hypertensives, identified from previous studies, constituted the universe. The participants were randomized into one control and three interventional groups. A total of 113 subjects: 30, 28, 28 and 27 in four groups respectively participated for eight weeks: control (I), physical exercise (II) - brisk walking for 50-60 minutes, four days/week, salt intake reduction (III) - to at least half of their previous intake, and practice of yoga (IV) - for 30-45 minutes/day on at least five days/week. Efficacy was assessed using paired t test and ANOVA with Games Howell post hoc test. An intention to treat analysis was also performed. A total of 102 participants (29, 27, 25 and 21 in groups I, II, III and IV) completed the study. All three intervention groups showed a significant reduction in BP (SBP/DBP: 5.3/6.0 in group II, 2.6/3.7 in III, and 2.0/2.6 mm Hg in IV respectively). There was no significant change (SBP/DBP: 0.2/0.5 mmHg) of BP in control group (I). Physical exercise was most effective (considered individually); salt intake reduction and yoga were also effective. Physical exercise, salt intake reduction, and yoga are effective non-pharmacological interventions in significantly reducing BP among young hypertensives and pre-hypertensives. These can therefore be positively recommended for hypertensives. There is also a case to deploy these interventions in the general population.

Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes

PubMed Central

2013-01-01

Background The association between pulmonary tuberculosis (PTB) and diabetes mellitus (DM) has been previously attracted much attention. Diabetes alters immunity to tuberculosis, leading to more frequent treatment failure in TB patients with DM. Moreover, TB and DM often coincide with micronutrients deficiencies, such as retinol and vitamin D, which are especially important to immunity of the body and may influence pancreas β-cell function. However, the effects of retinol and vitamin D supplementation in active TB patients with diabetes on treatment outcomes, immune and nutrition state are still uncertain. We are conducting a randomized controlled trial of vitamin A and/or D in active PTB patients with DM in a network of 4 TB treatment clinics to determine whether the supplementation could improve the outcome in the patients. Methods/design This is a 2×2 factorial trial. We plan to enroll 400 active PTB patients with DM, and randomize them to VA (2000 IU daily retinol); VD (400 IU daily cholecalciferol); VAD (2000 IU daily retinol plus 400 IU cholecalciferol) or control (placebo) group. Our primary outcome measure is the efficacy of anti-tuberculosis treatment and ameliorating of glucose metabolism, and the secondary outcome measure being immune and nutrition status of the subjects. Of the first 37 subjects enrolled: 8 have been randomized to VA, 10 to VD, 9 to VAD and 10 to control. To date, the sample is 97.3% Han Chinese and 91.9% female. The average fasting plasma glucose level is 12.19 mmol/L. Discussion This paper describes the design and rationale of a randomized clinical trial comparing VA and/or VD supplementation to active pulmonary TB patients with DM. Our trial will allow rigorous evaluation of the efficacy of the supplementation to active TB and DM therapy for improving clinical outcomes and immunological condition. This detailed description of trial methodology can serve as a template for the development of future treatment scheme for active TB patient with DM. Trial registration ChiCTR-TRC-12002546 PMID:23442225

Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial

PubMed Central

2013-01-01

Background A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention. Methods/design To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention. Discussion Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been unsuccessful. By using a stepped wedge design, and obtain high management commitment and support we intend to improve implementation and aim to establish the effectiveness of a multi-faceted intervention to prevent low back pain. This study will potentially provide knowledge of prevention of low back pain and its consequences among nurses’ aides. Results are expected to be published in 2015–2016. Trial registration The study is registered as ISRCTN78113519. PMID:24261985

Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes.

PubMed

Wang, Qiuzhen; Ma, Aiguo; Bygbjerg, Ib Christian; Han, Xiuxia; Liu, Yufeng; Zhao, Shanliang; Cai, Jing

2013-02-26

The association between pulmonary tuberculosis (PTB) and diabetes mellitus (DM) has been previously attracted much attention. Diabetes alters immunity to tuberculosis, leading to more frequent treatment failure in TB patients with DM. Moreover, TB and DM often coincide with micronutrients deficiencies, such as retinol and vitamin D, which are especially important to immunity of the body and may influence pancreas β-cell function. However, the effects of retinol and vitamin D supplementation in active TB patients with diabetes on treatment outcomes, immune and nutrition state are still uncertain. We are conducting a randomized controlled trial of vitamin A and/or D in active PTB patients with DM in a network of 4 TB treatment clinics to determine whether the supplementation could improve the outcome in the patients. This is a 2×2 factorial trial. We plan to enroll 400 active PTB patients with DM, and randomize them to VA (2000 IU daily retinol); VD (400 IU daily cholecalciferol); VAD (2000 IU daily retinol plus 400 IU cholecalciferol) or control (placebo) group. Our primary outcome measure is the efficacy of anti-tuberculosis treatment and ameliorating of glucose metabolism, and the secondary outcome measure being immune and nutrition status of the subjects. Of the first 37 subjects enrolled: 8 have been randomized to VA, 10 to VD, 9 to VAD and 10 to control. To date, the sample is 97.3% Han Chinese and 91.9% female. The average fasting plasma glucose level is 12.19 mmol/L. This paper describes the design and rationale of a randomized clinical trial comparing VA and/or VD supplementation to active pulmonary TB patients with DM. Our trial will allow rigorous evaluation of the efficacy of the supplementation to active TB and DM therapy for improving clinical outcomes and immunological condition. This detailed description of trial methodology can serve as a template for the development of future treatment scheme for active TB patient with DM. ChiCTR-TRC-12002546.

Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

PubMed Central

Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C.

2015-01-01

Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

Neurofeedback reduces overeating episodes in female restrained eaters: a randomized controlled pilot-study.

PubMed

Schmidt, Jennifer; Martin, Alexandra

2015-12-01

Overeating episodes, despite of intentions to control weight, are a common problem among women. Recurring episodes of overeating and dietary failure have been reported to result in higher Body Mass Indexes and to induce severe distress even in non-clinical groups. Based on findings from physiological research on eating behavior and craving, as well as previous biofeedback studies, we derived a cue exposure based EEG neurofeedback protocol to target overeating episodes. The treatment was evaluated in a randomized controlled trial, comparing a neurofeedback group (NFG; n = 14) with a waiting list control group (WLG; n = 13) in a sub-clinical sample of female restrained eaters. At post-treatment, the number of weekly overeating episodes and subsequent distress were significantly reduced in the NFG compared to the WLG (p < .01; r > .50). In a 3 month follow-up, effects in the NFG remained stable. As secondary outcomes, perceived dieting success was enhanced after the treatment. At follow-up, additional beneficial effects on trait food craving were observed. Altogether, we found preliminary evidence for the cue exposure neurofeedback against overeating episodes in female restrained eaters, although specific effects and underlying mechanisms still have to be explored in future research.

Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial.

PubMed

Leśniak, Marcin; Polanowska, Katarzyna; Seniów, Joanna; Członkowska, Anna

2014-01-01

To determine whether cumulative anodal transcranial direct current stimulation (A-tDCS) of the left dorsolateral prefrontal cortex (DLPFC) could enhance rehabilitation of memory and attention in patients with traumatic brain injury (TBI). Inpatient and outpatient neurorehabilitation unit. Twenty-three adult patients, 4- to 92- months post severe TBI. Participants were randomly allocated to 2 groups. The experimental group received A-tDCS (10 minutes; 1 mA; in the DLPFC), followed by rehabilitative cognitive training, daily for 15 days. Controls received A-tDCS for 25 seconds (sham condition) with the same rehabilitation. Battery of memory and attention tests, which included visual and auditory modalities. Participants were tested twice before beginning rehabilitation (to control for spontaneous recovery), after rehabilitation completion, and 4 months later. Tests scores in both groups were similar at 3 weeks before and immediately before treatment. After treatment, the experimental group exhibited larger effect sizes in 6 of 8 cognitive outcome measures, but they were not significantly different from controls. At follow-up, differences remained insignificant. In contrast to previous studies, our study did not provide sufficient evidence to support the efficacy of repeated A-tDCS for enhancing rehabilitation of memory and attention in patients after severe TBI.

Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

PubMed

Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C; Milella, Luigi

2015-01-01

Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20-40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits.

Goal management training of executive functions in patients with spina bifida: a randomized controlled trial.

PubMed

Stubberud, Jan; Langenbahn, Donna; Levine, Brian; Stanghelle, Johan; Schanke, Anne-Kristine

2013-07-01

Executive dysfunction causes significant real-life disability for patients with spina bifida (SB). However, no previous research has been directed toward the amelioration of executive functioning deficits amongst persons with SB. Goal Management Training (GMT) is a compensatory cognitive rehabilitation approach, addressing underlying deficits in sustained attention to improve executive function. GMT has received empirical support in studies of other patient groups. The purpose of the present study was to determine the efficacy of GMT in treating subjects with SB, using inpatient intervention periods. We hypothesized post-intervention changes in scores on neuropsychological measures to reflect improved attentional control, including sustained attention and inhibitory control. Thirty-eight adult subjects with SB were included in this randomized controlled trial. Inclusion was based upon the presence of executive functioning complaints. Experimental subjects (n = 24) received 21 hr of GMT, with efficacy of GMT being compared to results of subjects in a wait-list condition (n = 14). All subjects were assessed at baseline, post-intervention, and at 6-month follow-up. Findings indicated superior effects of GMT on domain-specific neuropsychological measures and on a functional "real-life" measure, all lasting at least 6 months post-treatment. These results show that deficits in executive functioning can be ameliorated in patients with congenital brain dysfunction.

A randomized, controlled trial of negative pressure wound therapy of pressure ulcers via a novel polyurethane foam.

PubMed

Wagstaff, Marcus James Dermot; Driver, Sara; Coghlan, Patrick; Greenwood, John Edward

2014-01-01

The objectives of the study were (1) to look for any local, clinically apparent response, within and around a debrided wound, to a novel biocompatible polyurethane foam during repeated, short-term implantation, and (2) to assess the material's efficacy as a negative pressure wound therapy (NPWT) interface compared with a widely used, commercially available foam. Twenty pressure ulcers in 18 patients underwent surgical debridement, then randomization to receive novel treatment or control foam as the wound interface for NPWT. Dressing changes every 2-3 days allowed qualitative wound assessment and quantitative measurement to compare outcomes. No adverse reaction was observed in any patient receiving the new foam. The new "novel foam" performed as a NPWT interface as effectively as the control "standard foam." In deep wounds, the new foam was easier to remove, fragmented less, and showed less retention than the control foam. No marginal in-growth occurred, making removal less traumatic and reducing bleeding from cavity wall granulations. The results support previous large animal studies, and independent ISO10993 testing, that the new foam is safe and biocompatible. Its efficacy as an NPWT interface, nontraumatic removal with low fragmentation and retention rate, favors the new material, especially in deep cavity wounds. © 2014 by the Wound Healing Society.

Bolus Calculator Reduces Hypoglycemia in the Short Term and Fear of Hypoglycemia in the Long Term in Subjects with Type 1 Diabetes (CBMDI Study)

PubMed Central

Carreira, Mónica; Anarte, María Teresa; Linares, Francisca; Olveira, Gabriel; González Romero, Stella

2017-01-01

Abstract Background: In a previous study we demonstrated improvement in metabolic control and reduction in hypoglycemia in people with type 1 diabetes on multiple daily injections, after having used a bolus calculator for 4 months. Objective: To demonstrate whether (1) extending its use (2) or introducing it in the control group, previously subjected to treatment intensification, could further improve metabolic control and related psychological issues. Methods: After the previous clinical trial, in which the subjects were randomized either to treatment with the calculator or to control group for 4 months, both groups used the calculator during an additional 4-month period. Results: In the previous control group, after using the device, HbA1c did not improve (7.86% ± 0.87% vs. 8.01% ± 0.93%, P 0.215), although a significant decrease in postprandial hypoglycemia was observed (2.3 ± 2 vs. 1.1 ± 1.2/2 weeks, P 0.002). In the group in which the treatment was extended from 4 to 8 months, HbA1c did not improve either (7.61 ± 0.58 vs. 7.73 ± 0.65, P 0.209); however this group had a greater perceived treatment satisfaction (12.03 ± 4.26 vs. 13.71 ± 3.75, P 0.007) and a significant decrease in fear of hypoglycemia (28.24 ± 8.18 basal vs. 25.66 ± 8.02 at 8 months, P 0.026). Conclusions: The extension in the use of the calculator or its introduction in a previously intensified control group did not improve metabolic control, although it did confirm a decrease in hypoglycemic episodes in the short term, while the extension of its use to 8 months was associated with a reduction in fear of hypoglycemia and greater treatment satisfaction. PMID:28594575

Conservatism and "copy-if-better" in chimpanzees (Pan troglodytes).

PubMed

van Leeuwen, Edwin J C; Call, Josep

2017-05-01

Social learning is predicted to evolve in socially living animals provided the learning process is not random but biased by certain socio-ecological factors. One bias of particular interest for the emergence of (cumulative) culture is the tendency to forgo personal behaviour in favour of relatively better variants observed in others, also known as the "copy-if-better" strategy. We investigated whether chimpanzees employ copy-if-better in a simple token-exchange paradigm controlling for individual and random social learning. After being trained on one token-type, subjects were confronted with a conspecific demonstrator who either received the same food reward as the subject (control condition) or a higher value food reward than the subject (test condition) for exchanging another token-type. In general, the chimpanzees persisted in exchanging the token-type they were trained on individually, indicating a form of conservatism consistent with previous studies. However, the chimpanzees were more inclined to copy the demonstrator in the test compared to the control condition, indicating a tendency to employ a copy-if-better strategy. We discuss the validity of our results by considering alternative explanations and relate our findings to the emergence of cumulative culture.

Enhanced visual statistical learning in adults with autism

PubMed Central

Roser, Matthew E.; Aslin, Richard N.; McKenzie, Rebecca; Zahra, Daniel; Fiser, József

2014-01-01

Individuals with autism spectrum disorder (ASD) are often characterized as having social engagement and language deficiencies, but a sparing of visuo-spatial processing and short-term memory, with some evidence of supra-normal levels of performance in these domains. The present study expanded on this evidence by investigating the observational learning of visuospatial concepts from patterns of covariation across multiple exemplars. Child and adult participants with ASD, and age-matched control participants, viewed multi-shape arrays composed from a random combination of pairs of shapes that were each positioned in a fixed spatial arrangement. After this passive exposure phase, a post-test revealed that all participant groups could discriminate pairs of shapes with high covariation from randomly paired shapes with low covariation. Moreover, learning these shape-pairs with high covariation was superior in adults with ASD than in age-matched controls, while performance in children with ASD was no different than controls. These results extend previous observations of visuospatial enhancement in ASD into the domain of learning, and suggest that enhanced visual statistical learning may have arisen from a sustained bias to attend to local details in complex arrays of visual features. PMID:25151115

Impact of long-term contraceptive promotion on incident pregnancy: a randomized controlled trial among HIV-positive couples in Lusaka, Zambia.

PubMed

Wall, Kristin M; Vwalika, Bellington; Haddad, Lisa; Khu, Naw H; Vwalika, Cheswa; Kilembe, William; Chomba, Elwyn; Stephenson, Rob; Kleinbaum, David; Nizam, Azhar; Brill, Ilene; Tichacek, Amanda; Allen, Susan

2013-05-01

To evaluate the impact of family planning promotion on incident pregnancy in a combined effort to address Prongs 1 and 2 of prevention of mother-to-child transmission of HIV. We conducted a factorial randomized controlled trial of 2 video-based interventions. "Methods" and "Motivational" messages promoted long-term contraceptive use among 1060 couples with HIV in Lusaka, Zambia. Among couples not using contraception before randomization (n = 782), the video interventions had no impact on incident pregnancy. Among baseline contraceptive users, viewing the "Methods video" which focused on the intrauterine device and contraceptive implant was associated with a significantly lower pregnancy incidence [hazard ratio (HR) = 0.38; 95% confidence interval (CI): 0.19 to 0.75] relative to those viewing control and/or motivational videos. The effect was strongest in concordant positive couples (HR = 0.22; 95% CI: 0.08 to 0.58) and couples with HIV-positive women (HR = 0.23; 95% CI: 0.09 to 0.55). The "Methods video" intervention was previously shown to increase uptake of long-acting contraception and to prompt a shift from daily oral contraceptives to quarterly injectables and long-acting methods such as the intrauterine device and implant. Follow-up confirms sustained intervention impact on pregnancy incidence among baseline contraceptive users, in particular couples with HIV-positive women. Further work is needed to identify effective interventions to promote long-acting contraception among couples who have not yet adopted modern methods.

A randomized controlled trial for the effect of passive stretching on measures of hamstring extensibility, passive stiffness, strength, and stretch tolerance.

PubMed

Marshall, Paul W M; Cashman, Anthony; Cheema, Birinder S

2011-11-01

To measure hamstring extensibility, stiffness, stretch tolerance, and strength following a 4-week passive stretching program. Randomized controlled trial. Twenty-two healthy participants were randomly assigned to either a 4-week stretching program consisting of 4 hamstring and hip stretches performed 5 times per week, or a non-stretching control group. Hamstring extensibility and stiffness were measured before and after training using the instrumented straight leg raise test (iSLR). Stretch tolerance was measured as the pain intensity (visual analog scale; VAS) elicited during the maximal stretch. Hamstring strength was measured using isokinetic dynamometry at 30 and 120° s(-1). Hamstring extensibility increased by 20.9% in the intervention group following 4 weeks of training (p<0.001; d=0.86). Passive stiffness was reduced by 31% in the intervention group (p<0.05; d=-0.89). Stretch tolerance VAS scores were not different between groups at either time point, and no changes were observed following training. There were no changes in hamstring concentric strength measured at 30 and 120° s(-1). Passive stretching increases hamstring extensibility and decreases passive stiffness, with no change in stretch tolerance defined by pain intensity during the stretch. Compared to previous research, the volume of stretching was higher in this study. The volume of prescribed stretching is important for eliciting the strong clinical effect observed in this study. Copyright © 2011 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: long-term follow-up of a randomized controlled trial.

PubMed

Hallén, Magnus; Bergenfelz, Anders; Westerdahl, Johan

2008-03-01

We have conducted a randomized controlled trial of totally extraperitoneal hernia repair (TEP) versus tension-free open repair (Lichtenstein repair); we have presented the results previously up to 1 year after the operation. The aim of this study was to compare patient outcome in both groups at a median follow-up of 7.3 years after operation. Of 168 patients included in a prospective, randomized controlled trial designed to compare TEP with an open tension-free technique, 154 patients (92%) answered a questionnaire and 147 patients (88%) were followed up at an outpatient clinic after a minimum of 6 years after operation. Overall, 89% of patients in the TEP group and 95% of patients in the open group reported complete long-term recovery (P = .23). Permanent impaired inguinal sensibility was more common in the open group (P = .004), whereas the proportion of patients with reported testicular pain was higher in the TEP group (P = .003). Three recurrences were found in the TEP group, and 4 recurrences were found in the open group (P = .99). Four patients in the TEP group underwent operations for complications related to the hernia repair (small bowel obstruction, umbilical hernia, testicular pain, and neuralgia). Overall, both groups showed good long-term results with low rates of recurrences. However, the TEP group was associated with a higher proportion of patients with long-term testicular pain, whereas impaired inguinal sensibility was more common in the open group.

Effects of music on physiological and behavioral responses of premature infants: a randomized controlled trial.

PubMed

Alipour, Zahra; Eskandari, Narges; Ahmari Tehran, Hoda; Eshagh Hossaini, Seyed Kamal; Sangi, Sareh

2013-08-01

Despite persuasive theories about the beneficial effects of music and singing in developmental care for premature infants, few small studies are available in this regard. We conducted this study to investigate the physiological and behavioral responses of premature infants to recorded lullaby music and silence. In a randomized controlled trial, 90 premature infants in the neonatal care unit of a hospital in Qom (Iran) were randomly allocated to intervention (lullaby and silence) or control groups. Lullaby music was played via headphones at a volume of 50-60 dB. In the silence group, headphones were placed on the infants' ears while no music was played. The three groups were surveyed for physiological responses including oxygen saturation, respiratory and heart rates, and behavioral states every five minutes before, during, and after the intervention. The three groups were not significantly different in terms of mean values of respiratory and heart rates, oxygen saturation, and behavioral states of infants. Similarly, no significant within group differences in respiratory and heart rates, oxygen saturation, and behavioral states were observed at different times. Our findings did not support the beneficial effects of music for premature infants. However, music is a noninvasive, non-pharmaceutical, and relatively low-cost intervention that can be implemented at infants' bedside. Thus further research is warranted to determine whether the effects noted in previous studies can be consistently replicated in diverse settings and with diverse groups of preterm infants. Copyright © 2013 Elsevier Ltd. All rights reserved.

Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.

PubMed

Ferrando, Carlos; Soro, Marina; Canet, Jaume; Unzueta, Ma Carmen; Suárez, Fernando; Librero, Julián; Peiró, Salvador; Llombart, Alicia; Delgado, Carlos; León, Irene; Rovira, Lucas; Ramasco, Fernando; Granell, Manuel; Aldecoa, César; Diaz, Oscar; Balust, Jaume; Garutti, Ignacio; de la Matta, Manuel; Pensado, Alberto; Gonzalez, Rafael; Durán, M Eugenia; Gallego, Lucia; Del Valle, Santiago García; Redondo, Francisco J; Diaz, Pedro; Pestaña, David; Rodríguez, Aurelio; Aguirre, Javier; García, Jose M; García, Javier; Espinosa, Elena; Charco, Pedro; Navarro, Jose; Rodríguez, Clara; Tusman, Gerardo; Belda, Francisco Javier

2015-04-27

Postoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative lung-protective approach. The trial presented here aims at comparing postoperative complications when using an individualized ventilatory management strategy in the intraoperative and immediate postoperative periods with those when using a standard protective ventilation strategy in patients scheduled for major abdominal surgery. This is a comparative, prospective, multicenter, randomized, and controlled, four-arm trial that will include 1012 patients with an intermediate or high risk for postoperative pulmonary complications. The patients will be divided into four groups: (1) individualized perioperative group: intra- and postoperative individualized strategy; (2) intraoperative individualized strategy + postoperative continuous positive airway pressure (CPAP); (3) intraoperative standard ventilation + postoperative CPAP; (4) intra- and postoperative standard strategy (conventional strategy). The primary outcome is a composite analysis of postoperative complications. The Individualized Perioperative Open-lung Ventilatory Strategy (iPROVE) is the first multicenter, randomized, and controlled trial to investigate whether an individualized perioperative approach prevents postoperative pulmonary complications. Registered on 5 June 2014 with identification no. NCT02158923 .

Influence of therapist competence and quantity of cognitive behavioural therapy on suicidal behaviour and inpatient hospitalisation in a randomised controlled trial in borderline personality disorder: Further analyses of treatment effects in the BOSCOT study

PubMed Central

Norrie, John; Davidson, Kate; Tata, Philip; Gumley, Andrew

2013-01-01

Objectives We investigated the treatment effects reported from a high-quality randomized controlled trial of cognitive behavioural therapy (CBT) for 106 people with borderline personality disorder attending community-based clinics in the UK National Health Service – the BOSCOT trial. Specifically, we examined whether the amount of therapy and therapist competence had an impact on our primary outcome, the number of suicidal acts†, using instrumental variables regression modelling. Design Randomized controlled trial. Participants from across three sites (London, Glasgow, and Ayrshire/Arran) were randomized equally to CBT for personality disorders (CBTpd) plus Treatment as Usual or to Treatment as Usual. Treatment as Usual varied between sites and individuals, but was consistent with routine treatment in the UK National Health Service at the time. CBTpd comprised an average 16 sessions (range 0–35) over 12 months. Method We used instrumental variable regression modelling to estimate the impact of quantity and quality of therapy received (recording activities and behaviours that took place after randomization) on number of suicidal acts and inpatient psychiatric hospitalization. Results A total of 101 participants provided full outcome data at 2 years post randomization. The previously reported intention-to-treat (ITT) results showed on average a reduction of 0.91 (95% confidence interval 0.15–1.67) suicidal acts over 2 years for those randomized to CBT. By incorporating the influence of quantity of therapy and therapist competence, we show that this estimate of the effect of CBTpd could be approximately two to three times greater for those receiving the right amount of therapy from a competent therapist. Conclusions Trials should routinely control for and collect data on both quantity of therapy and therapist competence, which can be used, via instrumental variable regression modelling, to estimate treatment effects for optimal delivery of therapy. Such estimates complement rather than replace the ITT results, which are properly the principal analysis results from such trials. Practitioner points Assessing the impact of the quantity and quality of therapy (competence of therapists) is complex. More competent therapists, trained in CBTpd, may significantly reduce the number of suicidal act in patients with borderline personality disorder. PMID:23420622

Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial.

PubMed

Bucur, Roxana C; Reid, Lauren S; Hamilton, Celeste J; Cummings, Steven R; Jamal, Sophie A

2013-09-08

Organic nitrates uncouple bone turnover, improve bone mineral density, and improve trabecular and cortical components of bone. These changes in turnover, strength and geometry may translate into an important reduction in fractures. However, before proceeding with a large fracture trial, there is a need to identify the nitrate formulation that has both the greatest efficacy (with regards to bone turnover markers) and gives the fewest headaches. Ascertaining which nitrate formulation this may be is the purpose of the current study. This will be an open-label randomized, controlled trial conducted at Women's College Hospital comparing five formulations of nitrates for their effects on bone turnover markers and headache. We will recruit postmenopausal women age 50 years or older with no contraindications to nitroglycerin. Our trial will consist of a run-in phase and a treatment phase. We will enroll 420 women in the run-in phase, each to receive all of the 5 potential treatments in random order for 2 days, each with a 2-day washout period between treatments. Those who tolerate all formulations will enter the 12-week treatment phase and be randomly assigned to one of five groups: 0.3 mg sublingual nitroglycerin tablet, 0.6 mg of the sublingual tablet, a 20 mg tablet of isosorbide mononitrate, a 160 mg nitroglycerin transdermal patch (used for 8 h), and 15 mg of nitroglycerin ointment as used in a previous trial by our group. We will continue enrolment until we have randomized 210 women or 35 women per group. Concentrations of bone formation (bone-specific alkaline phosphatase and procollagen type I N-terminal propeptide) and bone resorption (C-telopeptides of collagen crosslinks and N-terminal crosslinks of collagen) agents will be measured in samples taken at study entry (the start of the run in phase) and 12 weeks. Subjects will record the frequency and severity of headaches daily during the run-in phase and then monthly after that. We will use the 'multiple comparisons with the best' approach for data analyses, as this strategy allows practical considerations of ease of use and tolerability to guide selection of the preparation for future studies. Data from this protocol will be used to develop a randomized, controlled trial of nitrates to prevent osteoporotic fractures. ClinicalTrials.gov Identifier: NCT01387672. Controlled-Trials.com: ISRCTN08860742.

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

Impact of random and systematic recall errors and selection bias in case--control studies on mobile phone use and brain tumors in adolescents (CEFALO study).

PubMed

Aydin, Denis; Feychting, Maria; Schüz, Joachim; Andersen, Tina Veje; Poulsen, Aslak Harbo; Prochazka, Michaela; Klaeboe, Lars; Kuehni, Claudia E; Tynes, Tore; Röösli, Martin

2011-07-01

Whether the use of mobile phones is a risk factor for brain tumors in adolescents is currently being studied. Case--control studies investigating this possible relationship are prone to recall error and selection bias. We assessed the potential impact of random and systematic recall error and selection bias on odds ratios (ORs) by performing simulations based on real data from an ongoing case--control study of mobile phones and brain tumor risk in children and adolescents (CEFALO study). Simulations were conducted for two mobile phone exposure categories: regular and heavy use. Our choice of levels of recall error was guided by a validation study that compared objective network operator data with the self-reported amount of mobile phone use in CEFALO. In our validation study, cases overestimated their number of calls by 9% on average and controls by 34%. Cases also overestimated their duration of calls by 52% on average and controls by 163%. The participation rates in CEFALO were 83% for cases and 71% for controls. In a variety of scenarios, the combined impact of recall error and selection bias on the estimated ORs was complex. These simulations are useful for the interpretation of previous case-control studies on brain tumor and mobile phone use in adults as well as for the interpretation of future studies on adolescents. Copyright © 2011 Wiley-Liss, Inc.

Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Limited controlled data exist to guide treatment choices for clinicians caring for patients with major depressive disorder (MDD). Although many putative predictors of treatment response have been reported, most were identified through retrospective analyses of existing datasets and very few have been replicated in a manner that can impact clinical practice. One major confound in previous studies examining predictors of treatment response is the patient’s treatment history, which may affect both the predictor of interest and treatment outcomes. Moreover, prior treatment history provides an important source of selection bias, thereby limiting generalizability. Consequently, we initiated a randomized clinical trial designed to identify factors that moderate response to three treatments for MDD among patients never treated previously for the condition. Methods/design Treatment-naïve adults aged 18 to 65 years with moderate-to-severe, non-psychotic MDD are randomized equally to one of three 12-week treatment arms: (1) cognitive behavior therapy (CBT, 16 sessions); (2) duloxetine (30–60 mg/d); or (3) escitalopram (10–20 mg/d). Prior to randomization, patients undergo multiple assessments, including resting state functional magnetic resonance imaging (fMRI), immune markers, DNA and gene expression products, and dexamethasone-corticotropin-releasing hormone (Dex/CRH) testing. Prior to or shortly after randomization, patients also complete a comprehensive personality assessment. Repeat assessment of the biological measures (fMRI, immune markers, and gene expression products) occurs at an early time-point in treatment, and upon completion of 12-week treatment, when a second Dex/CRH test is also conducted. Patients remitting by the end of this acute treatment phase are then eligible to enter a 21-month follow-up phase, with quarterly visits to monitor for recurrence. Non-remitters are offered augmentation treatment for a second 12-week course of treatment, during which they receive a combination of CBT and antidepressant medication. Predictors of the primary outcome, remission, will be identified for overall and treatment-specific effects, and a statistical model incorporating multiple predictors will be developed to predict outcomes. Discussion The PReDICT study’s evaluation of biological, psychological, and clinical factors that may differentially impact treatment outcomes represents a sizeable step toward developing personalized treatments for MDD. Identified predictors should help guide the selection of initial treatments, and identify those patients most vulnerable to recurrence, who thus warrant maintenance or combination treatments to achieve and maintain wellness. Trial registration Clinicaltrials.gov Identifier: NCT00360399. Registered 02 AUG 2006. First patient randomized 09 FEB 2007. PMID:22776534

Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial.

PubMed

Huo, Jian; Liu, Li-Sha; Jian, Wen-Yuan; Zeng, Jie-Ping; Duan, Jun-Guo; Lu, Xue-Jing; Yin, Shuo

2018-06-18

Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).

3D surface perception from motion involves a temporal–parietal network

PubMed Central

Beer, Anton L.; Watanabe, Takeo; Ni, Rui; Sasaki, Yuka; Andersen, George J.

2010-01-01

Previous research has suggested that three-dimensional (3D) structure-from-motion (SFM) perception in humans involves several motion-sensitive occipital and parietal brain areas. By contrast, SFM perception in nonhuman primates seems to involve the temporal lobe including areas MT, MST and FST. The present functional magnetic resonance imaging study compared several motion-sensitive regions of interest including the superior temporal sulcus (STS) while human observers viewed horizontally moving dots that defined either a 3D corrugated surface or a 3D random volume. Low-level stimulus features such as dot density and velocity vectors as well as attention were tightly controlled. Consistent with previous research we found that 3D corrugated surfaces elicited stronger responses than random motion in occipital and parietal brain areas including area V3A, the ventral and dorsal intraparietal sulcus, the lateral occipital sulcus and the fusiform gyrus. Additionally, 3D corrugated surfaces elicited stronger activity in area MT and the STS but not in area MST. Brain activity in the STS but not in area MT correlated with interindividual differences in 3D surface perception. Our findings suggest that area MT is involved in the analysis of optic flow patterns such as speed gradients and that the STS in humans plays a greater role in the analysis of 3D SFM than previously thought. PMID:19674088

Real-time, adaptive machine learning for non-stationary, near chaotic gasoline engine combustion time series.

PubMed

Vaughan, Adam; Bohac, Stanislav V

2015-10-01

Fuel efficient Homogeneous Charge Compression Ignition (HCCI) engine combustion timing predictions must contend with non-linear chemistry, non-linear physics, period doubling bifurcation(s), turbulent mixing, model parameters that can drift day-to-day, and air-fuel mixture state information that cannot typically be resolved on a cycle-to-cycle basis, especially during transients. In previous work, an abstract cycle-to-cycle mapping function coupled with ϵ-Support Vector Regression was shown to predict experimentally observed cycle-to-cycle combustion timing over a wide range of engine conditions, despite some of the aforementioned difficulties. The main limitation of the previous approach was that a partially acasual randomly sampled training dataset was used to train proof of concept offline predictions. The objective of this paper is to address this limitation by proposing a new online adaptive Extreme Learning Machine (ELM) extension named Weighted Ring-ELM. This extension enables fully causal combustion timing predictions at randomly chosen engine set points, and is shown to achieve results that are as good as or better than the previous offline method. The broader objective of this approach is to enable a new class of real-time model predictive control strategies for high variability HCCI and, ultimately, to bring HCCI's low engine-out NOx and reduced CO2 emissions to production engines. Copyright © 2015 Elsevier Ltd. All rights reserved.

Isotopically enhanced triple-quantum-dot qubit

PubMed Central

Eng, Kevin; Ladd, Thaddeus D.; Smith, Aaron; Borselli, Matthew G.; Kiselev, Andrey A.; Fong, Bryan H.; Holabird, Kevin S.; Hazard, Thomas M.; Huang, Biqin; Deelman, Peter W.; Milosavljevic, Ivan; Schmitz, Adele E.; Ross, Richard S.; Gyure, Mark F.; Hunter, Andrew T.

2015-01-01

Like modern microprocessors today, future processors of quantum information may be implemented using all-electrical control of silicon-based devices. A semiconductor spin qubit may be controlled without the use of magnetic fields by using three electrons in three tunnel-coupled quantum dots. Triple dots have previously been implemented in GaAs, but this material suffers from intrinsic nuclear magnetic noise. Reduction of this noise is possible by fabricating devices using isotopically purified silicon. We demonstrate universal coherent control of a triple-quantum-dot qubit implemented in an isotopically enhanced Si/SiGe heterostructure. Composite pulses are used to implement spin-echo type sequences, and differential charge sensing enables single-shot state readout. These experiments demonstrate sufficient control with sufficiently low noise to enable the long pulse sequences required for exchange-only two-qubit logic and randomized benchmarking. PMID:26601186

Personalized versus standardized dosing strategies for the treatment of childhood amblyopia: study protocol for a randomized controlled trial.

PubMed

Moseley, Merrick J; Wallace, Michael P; Stephens, David A; Fielder, Alistair R; Smith, Laura C; Stewart, Catherine E

2015-04-25

Amblyopia is the commonest visual disorder of childhood in Western societies, affecting, predominantly, spatial visual function. Treatment typically requires a period of refractive correction ('optical treatment') followed by occlusion: covering the nonamblyopic eye with a fabric patch for varying daily durations. Recent studies have provided insight into the optimal amount of patching ('dose'), leading to the adoption of standardized dosing strategies, which, though an advance on previous ad-hoc regimens, take little account of individual patient characteristics. This trial compares the effectiveness of a standardized dosing strategy (that is, a fixed daily occlusion dose based on disease severity) with a personalized dosing strategy (derived from known treatment dose-response functions), in which an initially prescribed occlusion dose is modulated, in a systematic manner, dependent on treatment compliance. A total of 120 children aged between 3 and 8 years of age diagnosed with amblyopia in association with either anisometropia or strabismus, or both, will be randomized to receive either a standardized or a personalized occlusion dose regimen. To avoid confounding by the known benefits of refractive correction, participants will not be randomized until they have completed an optical treatment phase. The primary study objective is to determine whether, at trial endpoint, participants receiving a personalized dosing strategy require fewer hours of occlusion than those in receipt of a standardized dosing strategy. Secondary objectives are to quantify the relationship between observed changes in visual acuity (logMAR, logarithm of the Minimum Angle of Resolution) with age, amblyopia type, and severity of amblyopic visual acuity deficit. This is the first randomized controlled trial of occlusion therapy for amblyopia to compare a treatment arm representative of current best practice with an arm representative of an entirely novel treatment regimen based on statistical modelling of previous trial outcome data. Should the personalized dosing strategy demonstrate superiority over the standardized dosing strategy, then its adoption into routine practice could bring practical benefits in reducing the duration of treatment needed to achieve an optimal outcome. ISRCTN ISRCTN12292232.

Phase II randomized trial of radiation therapy, cetuximab, and pemetrexed with or without bevacizumab in patients with locally advanced head and neck cancer.

PubMed

Argiris, A; Bauman, J E; Ohr, J; Gooding, W E; Heron, D E; Duvvuri, U; Kubicek, G J; Posluszny, D M; Vassilakopoulou, M; Kim, S; Grandis, J R; Johnson, J T; Gibson, M K; Clump, D A; Flaherty, J T; Chiosea, S I; Branstetter, B; Ferris, R L

2016-08-01

We previously reported the safety of concurrent cetuximab, an antibody against epidermal growth factor receptor (EGFR), pemetrexed, and radiation therapy (RT) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). In this non-comparative phase II randomized trial, we evaluated this non-platinum combination with or without bevacizumab, an inhibitor of vascular endothelial growth factor (VEGF). Patients with previously untreated stage III-IVB SCCHN were randomized to receive: conventionally fractionated radiation (70 Gy), concurrent cetuximab, and concurrent pemetrexed (arm A); or the identical regimen plus concurrent bevacizumab followed by bevacizumab maintenance for 24 weeks (arm B). The primary end point was 2-year progression-free survival (PFS), with each arm compared with historical control. Exploratory analyses included the relationship of established prognostic factors to PFS and quality of life (QoL). Seventy-eight patients were randomized: 66 oropharynx (42 HPV-positive, 15 HPV-negative, 9 unknown) and 12 larynx; 38 (49%) had heavy tobacco exposure. Two-year PFS was 79% [90% confidence interval (CI) 0.69-0.92; P < 0.0001] for arm A and 75% (90% CI 0.64-0.88; P < 0.0001) for arm B, both higher than historical control. No differences in PFS were observed for stage, tobacco history, HPV status, or type of center (community versus academic). A significantly increased rate of hemorrhage occurred in arm B. SCCHN-specific QoL declined acutely, with marked improvement but residual symptom burden 1 year post-treatment. RT with a concurrent non-platinum regimen of cetuximab and pemetrexed is feasible in academic and community settings, demonstrating expected toxicities and promising efficacy. Adding bevacizumab increased toxicity without apparent improvement in efficacy, countering the hypothesis that dual EGFR-VEGF targeting would overcome radiation resistance, and enhance clinical benefit. Further development of cetuximab, pemetrexed, and RT will require additional prospective study in defined, high-risk populations where treatment intensification is justified. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

[Withdrawal of a specialised diabetes education program in primary care: long term impact on the metabolic control outcomes].

PubMed

Jurado Campos, Jerónimo; Caula Ros, Jacint A; Hernández Anguera, Josep M; Juvinyà Canal, Dolors; Pou Torelló, José M

2009-12-01

To evaluate the possible relationships between a health policy decision, in relation to the diabetes education strategies and the metabolic control outcomes. Longitudinal prospective cohort study. A random cohort sample of 276 type II diabetes mellitus subjects. All primary care centres in three regions of Catalonia. Patients were classified as specialised (n=59) or non-specialised (n=217) groups, as regards whether having received previous diabetes education before the start of the study. HbA1c values were evaluated in all subjects at baseline and after 5 years after receiving only conventional education. Baseline evaluation showed a better metabolic control in the specialised group (P=0.009). The final evaluation showed no significant differences in outcomes between the two groups (P=0.679). When baseline and outcomes values were compared, significant differences were observed in all subjects (P=0.001), the specialised group showed significantly poorer metabolic control (P<0.001), but in the group with previous conventional education no significant differences were observed (P=0.058). Our results suggest that the withdrawal of higher levels of diabetes education may play a major role in poor metabolic control, and that conventional diabetes education does not improve outcomes. Health policy in Primary Care should consider improving the level of diabetes education.

New and old ways to control meiotic recombination.

PubMed

Phadnis, Naina; Hyppa, Randy W; Smith, Gerald R

2011-10-01

The unique segregation of homologs, rather than sister chromatids, at the first meiotic division requires the formation of crossovers (COs) between homologs by meiotic recombination in most species. Crossovers do not form at random along chromosomes. Rather, their formation is carefully controlled, both at the stage of formation of DNA double-strand breaks (DSBs) that can initiate COs and during the repair of these DSBs. Here, we review control of DSB formation and two recently recognized controls of DSB repair: CO homeostasis and CO invariance. Crossover homeostasis maintains a constant number of COs per cell when the total number of DSBs in a cell is experimentally or stochastically reduced. Crossover invariance maintains a constant CO density (COs per kb of DNA) across much of the genome despite strong DSB hotspots in some intervals. These recently uncovered phenomena show that CO control is even more complex than previously suspected. Copyright © 2011 Elsevier Ltd. All rights reserved.

Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong.

PubMed

Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

2016-07-29

Most positive psychology interventions conducted in the West have been focused on the individual. Family relationships are highly valued in the Chinese collectivist culture, and it is of interest to know whether family-focused interventions can improve the well-being of Chinese people. We have previously reported the effectiveness of a positive psychology family intervention in terms of family well-being. Based on the data derived from the Happy Family Kitchen II project, this paper examines the effectiveness of a community-based positive psychology family intervention on subjective happiness and health-related quality of life. Thirty-one social service units and schools organized intervention programs for 2070 participants in Hong Kong. In a cluster randomized controlled trial, participants were randomly assigned on the basis of computer-generated numbers into the intervention group or the control group. The intervention programs emphasized one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. The control group engaged in activities unrelated to the intervention, such as arts and crafts workshops. Subjective happiness and mental and physical quality of life were assessed at baseline and at 4 weeks and 12 weeks postintervention. Data of 1261 participants were analyzed. The results showed that the intervention was more effective than the control condition in improving subjective happiness, with a small effect size, at 12 weeks postintervention (β = .15, p = .020, Cohen's d = .16). However, there were no improvements in mental and physical quality of life in the intervention group compared with the control group at 4 weeks (β = .39, p = .494, d = .05; β = -.10, p = 1.000, d = -.01, respectively) and 12 weeks postintervention (β = .71, p = .233, d = .08; β = -.05, p = 1.000, d = -.01, respectively). Furthermore, the booster session was no more effective than the tea gathering session in improving subjective happiness (β = .00, p = .990, d = .00) or mental (β = 1.20, p = 1.000, d = -.04) and physical quality of life (β = .15, p = 1.000, d = -.01). The analyses extend previous findings of salutary effects on family well-being by showing that positive psychology family interventions can improve subjective happiness. Suggestions for future research are proposed. ClinicalTrials.gov NCT01796275 . Retrospectively registered 19 February 2013.

Implementing Group Medical Visits for Older Adults at Group Health Cooperative

PubMed Central

Levine, Martin D.; Ross, Tyler R.; Balderson, Benjamin H.K.; Phelan, Elizabeth A.

2010-01-01

In a pair of randomized controlled trials in Kaiser Colorado in the 1990s, Group Visits for older adults (monthly non disease-specific group medical appointments for a cohort of patients led by primary care teams) were proven to reduce costs, decrease hospitalizations, and improve patient and provider satisfaction. As part of a translational effort, this Group Visit intervention was replicated in a delivery system in Seattle, WA, and the log of total health care costs measured in the first year of the intervention. Utilization and patient and physician satisfaction were secondary outcomes. For the cost and utilization analysis, a retrospective case-control design compared 221 case patients 65 years of age and older with high outpatient utilization in the previous 18 months with 1,015 control patient selected randomly from clinics not participating in the intervention. Controls were matched to cases on the number of primary care visits in the prior 18 months. Total costs were not statistically different for intervention patients compared to controls ($8,845 vs. $10,288, p=0.11), nor were there statistically significant differences in utilization, including hospital admissions and outpatient visits. However, patient and provider satisfaction was high. This translational effort did not demonstrate the cost savings of the original efficacy trials. Possible explanations for these divergent results may have to do with differences in those who participated and differences between the two delivery systems. PMID:20002506

Partial-thickness burn wounds healing by topical treatment: A randomized controlled comparison between silver sulfadiazine and centiderm.

PubMed

Saeidinia, Amin; Keihanian, Faeze; Lashkari, Ardalan Pasdaran; Lahiji, Hossein Ghavvami; Mobayyen, Mohammadreza; Heidarzade, Abtin; Golchai, Javad

2017-03-01

Burns are common event and associated with a high incidence of death, disability, and high costs. Centella asiatica (L.) is a medicinal herb, commonly growing in humid areas in several tropical countries that improve wound healing. On the basis of previous studies, we compared the efficacy of Centiderm versus silver sulfadiazine (SSD) in partial thickness burning patients. Study population comprised burn victims referred to Velayat Burning Hospital at Rasht, Iran. The intervention group received Centiderm and control group SSD cream. Burn wounds were treated once daily at home. All of the wounds were evaluated till complete healing occurred and at the admission, days 3, 7, 14 objective signs; visual acuity score (VAS) and subjective signs were recorded. Re-epithelialization time and complete healing days were recorded. We used random fixed block for randomization. The randomization sequence was created using the computer. Patients and burning specialist physician were blinded. Seventy-five patients randomized into 2 groups; (40 patients: Centiderm group; 35 patients: SSD group). The mean age of them was 30.67 ± 9.91 years and 19 of them were male (31.7%). Thirty patients in Centiderm and 30 patients in SSD group were analyzed. All of objective and subjective signs and mean of re-epithelialization and complete healing were significantly better in Centiderm group rather than SSD group (P < 0.05). There was no infection in Centiderm group. We showed that use of Centiderm ointment not only improved the objective and subjective signs in less than 3 days, but also the re-epithelialization and complete healing rather than SSD without any infection in the subjects.

A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial.

PubMed

Vierhout, Bastiaan P; Saleem, Ben R; Ott, Alewijn; van Dijl, Jan Maarten; de Kempenaer, Ties D van Andringa; Pierie, Maurice E N; Bottema, Jan T; Zeebregts, Clark J

2015-09-14

Access for endovascular repair of abdominal aortic aneurysms (EVAR) is obtained through surgical cutdown or percutaneously. The only devices suitable for percutaneous closure of the 20 French arteriotomies of the common femoral artery (CFA) are the Prostar(™) and Proglide(™) devices (Abbott Vascular). Positive effects of these devices seem to consist of a lower infection rate, and shorter operation time and hospital stay. This conclusion was published in previous reports comparing techniques in patients in two different groups (cohort or randomized). Access techniques were never compared in one and the same patient; this research simplifies comparison because patient characteristics will be similar in both groups. Percutaneous access of the CFA is compared to surgical cutdown in a single patient; in EVAR surgery, access is necessary in both groins in each patient. Randomization is performed on the introduction site of the larger main device of the endoprosthesis. The contralateral device of the endoprosthesis is smaller. When we use this type of randomization, both groups will contain a similar number of main and contralateral devices. Preoperative nose cultures and perineal cultures are obtained, to compare colonization with postoperative wound cultures (in case of a surgical site infection). Furthermore, patient comfort will be considered, using VAS-scores (Visual analog scale). Punch biopsies of the groin will be harvested to retrospectively compare skin of patients who suffered a surgical site infection (SSI) to patients who did not have an SSI. The PiERO trial is a multicenter randomized controlled clinical trial designed to show the consequences of using percutaneous access in EVAR surgery and focuses on the occurrence of surgical site infections. NTR4257 10 November 2013, NL44578.042.13.

Comparison of efficacy and tolerance between combination therapy and monotherapy as first-line chemotherapy in elderly patients with advanced gastric cancer: Study protocol for a randomized controlled trial.

PubMed

Lee, Keun-Wook; Zang, Dae Young; Ryu, Min-Hee; Kim, Ki Hyang; Kim, Mi-Jung; Han, Hye Sook; Koh, Sung Ae; Park, Jin Hyun; Kim, Jin Won; Nam, Byung-Ho; Choi, In Sil

2017-12-01

The combination of a fluoropyrimidine [5-fluorouracil (5-FU), capecitabine, or S-1] with a platinum analog (cisplatin or oxaliplatin) is the most widely accepted first-line chemotherapy regimen for metastatic or recurrent advanced gastric cancer (AGC), based on the results of clinical trials. However, there is little evidence to guide chemotherapy for elderly patients with AGC because of under-representation of this age group in clinical trials. Thus, the aim of this study is to determine the optimal chemotherapy regimen for elderly patients with AGC by comparing the efficacies and safeties of combination therapy versus monotherapy as first-line chemotherapy. This study is a randomized, controlled, multicenter, phase III trial. A total of 246 elderly patients (≥70 years old) with metastatic or recurrent AGC who have not received previous palliative chemotherapy will be randomly allocated to a combination therapy group or a monotherapy group. Patients randomized to the combination therapy group will receive fluoropyrimidine plus platinum combination chemotherapy (capecitabine/cisplatin, S-1/cisplatin, capecitabine/oxaliplatin, or 5-FU/oxaliplatin), and those randomized to the monotherapy group will receive fluoropyrimidine monotherapy (capecitabine, S-1, or 5-FU). The primary outcome is the overall survival of patients in each treatment group. The secondary outcomes include progression-free survival, response rate, quality of life, and safety. We are conducting this pragmatic trial to determine whether elderly patients with AGC will obtain the same benefit from chemotherapy as younger patients. We expect that this study will help guide decision-making for the optimal treatment of elderly patients with AGC.

Patients' ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial.

PubMed

Umasunthar, T; Procktor, A; Hodes, M; Smith, J G; Gore, C; Cox, H E; Marrs, T; Hanna, H; Phillips, K; Pinto, C; Turner, P J; Warner, J O; Boyle, R J

2015-07-01

Previous work has shown patients commonly misuse adrenaline autoinjectors (AAI). It is unclear whether this is due to inadequate training, or poor device design. We undertook a prospective randomized controlled trial to evaluate ability to administer adrenaline using different AAI devices. We allocated mothers of food-allergic children prescribed an AAI for the first time to Anapen or EpiPen using a computer-generated randomization list, with optimal training according to manufacturer's instructions. After one year, participants were randomly allocated a new device (EpiPen, Anapen, new EpiPen, JEXT or Auvi-Q), without device-specific training. We assessed ability to deliver adrenaline using their AAI in a simulated anaphylaxis scenario six weeks and one year after initial training, and following device switch. Primary outcome was successful adrenaline administration at six weeks, assessed by an independent expert. Secondary outcomes were success at one year, success after switching device, and adverse events. We randomized 158 participants. At six weeks, 30 of 71 (42%) participants allocated to Anapen and 31 of 73 (43%) participants allocated to EpiPen were successful - RR 1.00 (95% CI 0.68-1.46). Success rates at one year were also similar, but digital injection was more common at one year with EpiPen (8/59, 14%) than Anapen (0/51, 0%, P = 0.007). When switched to a new device without specific training, success rates were higher with Auvi-Q (26/28, 93%) than other devices (39/80, 49%; P < 0.001). AAI device design is a major determinant of successful adrenaline administration. Success rates were low with several devices, but were high using the audio-prompt device Auvi-Q. © 2015 The Authors Allergy Published by John Wiley & Sons Ltd.

Randomized Controlled Trial Comparing Open Versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The CAPD I Trial.

PubMed

van Laanen, Jorinde H H; Cornelis, Tom; Mees, Barend M; Litjens, Elisabeth J; van Loon, Magda M; Tordoir, Jan H M; Peppelenbosch, Arnoud G

2018-01-01

To determine the best operation technique, open versus laparoscopic, for insertion of a peritoneal dialysis (PD) catheter with regard to clinical success. Clinical success was defined as an adequate function of the catheter 2 - 4 weeks after insertion. All patients with end-stage renal disease who were suitable for PD and gave informed consent were randomized for either open surgery or laparoscopic surgery. A previous laparotomy was not considered an exclusion criterion. Laparoscopic placement had the advantage of pre-peritoneal tunneling, the possibility for adhesiolysis, and placement of the catheter under direct vision. Catheter fixation techniques, omentopexy, or other adjunct procedures were not performed. Other measured parameters were in-hospital morbidity and mortality and post-operative infections. Between 2010 and 2016, 95 patients were randomized to this study protocol. After exclusion of 5 patients for various reasons, 44 patients received an open procedure and 46 patients a laparoscopic procedure. Gender, age, body mass index (BMI), hypertension, current hemodialysis, severe heart failure, and previous an abdominal operation were not significantly different between the groups. However, in the open surgery group, fewer patients had a previous median laparotomy compared with the laparoscopic group (6 vs 16 patients; p = 0.027). There was no statistically significant difference in mean operation time (36 ± 24 vs 38 ± 15 minutes) and hospital stay (2.1 ± 2.7 vs 3.1 ± 7.3 days) between the groups. In the open surgery group 77% of the patients had an adequate functioning catheter 2 - 4 weeks after insertion compared with 70% of patients in the laparoscopic group ( p = not significant [NS]). In the open surgery group there was 1 post-operative death (2%) compared with none in the laparoscopic group ( p = NS). The morbidity in both groups was low and not significantly different. In the open surgery group, 2 patients had an exit-site infection and 1 patient had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome. Copyright © 2018 International Society for Peritoneal Dialysis.

Set Shifting Training with Categorization Tasks

PubMed Central

Soveri, Anna; Waris, Otto; Laine, Matti

2013-01-01

The very few cognitive training studies targeting an important executive function, set shifting, have reported performance improvements that also generalized to untrained tasks. The present randomized controlled trial extends set shifting training research by comparing previously used cued training with uncued training. A computerized adaptation of the Wisconsin Card Sorting Test was utilized as the training task in a pretest-posttest experimental design involving three groups of university students. One group received uncued training (n = 14), another received cued training (n = 14) and the control group (n = 14) only participated in pre- and posttests. The uncued training group showed posttraining performance increases on their training task, but neither training group showed statistically significant transfer effects. Nevertheless, comparison of effect sizes for transfer effects indicated that our results did not differ significantly from the previous studies. Our results suggest that the cognitive effects of computerized set shifting training are mostly task-specific, and would preclude any robust generalization effects with this training. PMID:24324717

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

PubMed Central

2012-01-01

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

Acupuncture for alcohol withdrawal: a randomized controlled trial.

PubMed

Trümpler, François; Oez, Suzan; Stähli, Peter; Brenner, Hans Dieter; Jüni, Peter

2003-01-01

Previous trials on acupuncture in alcohol addiction were in outpatients and focused on relapse prevention. Rates of dropout were high and interpretation of results difficult. We compared auricular laser and needle acupuncture with sham laser stimulation in reducing the duration of alcohol withdrawal. Inpatients undergoing alcohol withdrawal were randomly allocated to laser acupuncture (n = 17), needle acupuncture (n = 15) or sham laser stimulation (n = 16). Attempts were made to blind patients, therapists and outcome assessors, but this was not feasible for needle acupuncture. The duration of withdrawal symptoms (as assessed using a nurse-rated scale) was the primary outcome; the duration of sedative prescription was the secondary outcome. Patients randomized to laser and sham laser had identical withdrawal symptom durations (median 4 days). Patients randomized to needle stimulation had a shorter duration of withdrawal symptoms (median 3 days; P = 0.019 versus sham intervention), and tended to have a shorter duration of sedative use, but these differences diminished after adjustment for baseline differences. The data from this pilot trial do not suggest a relevant benefit of auricular laser acupuncture for alcohol withdrawal. A larger trial including adequate sham interventions is needed, however, to reliably determine the effectiveness of any type of auricular acupuncture in this condition.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-07-02

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0). Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed Central

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-01-01

Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0). Conclusion Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed. PMID:19573242

Cognitive Behaviour Therapy for Bulimia Nervosa and Eating Disorders Not Otherwise Specified: Translation from Randomized Controlled Trial to a Clinical Setting.

PubMed

Knott, Sarah; Woodward, Debbie; Hoefkens, Antonia; Limbert, Caroline

2015-11-01

Enhanced Cognitive Behaviour Therapy (CBT-E) (Fairburn, Cooper and Shafran, 2003) was developed as a treatment approach for eating disorders focusing on both core psychopathology and additional maintenance mechanisms. To evaluate treatment outcomes associated with CBT-E in a NHS Eating Disorders Service for adults with bulimia and atypical eating disorders and to make comparisons with a previously published randomized controlled trial (Fairburn et al., 2009) and "real world" evaluation (Byrne, Fursland, Allen and Watson, 2011). Participants were referred to the eating disorder service between 2002 and 2011. They were aged between 18-65 years, registered with a General Practitioner within the catchment area, and had experienced symptoms fulfilling criteria for BN or EDNOS for a minimum of 6 months. CBT-E was commenced by 272 patients, with 135 completing treatment. Overall, treatment was associated with significant improvements in eating disorder and associated psychopathology, for both treatment completers and the intention to treat sample. Findings support dissemination of CBT-E in this context, with significant improvements in eating disorder psychopathology. Improvements to global EDE-Q scores were higher for treatment completers and lower for the intention to treat sample, compared to previous studies (Fairburn et al., 2009; Byrne et al., 2011). Level of attrition was found at 40.8% and non-completion of treatment was associated with higher levels of anxiety. Potential explanations for these findings are discussed.

Intensive exercise reduces the fear of additional falls in elderly people: findings from the Korea falls prevention study.

PubMed

Oh, Dong Hyun; Park, Ji Eun; Lee, Eon Sook; Oh, Sang Woo; Cho, Sung Il; Jang, Soong Nang; Baik, Hyun Wook

2012-12-01

Falls among older people are a major public health problem and may result in fracture, medical complications that require hospitalization, and fear of additional falls. Given the prevalence and impact of the fear of falling again, reducing the incidence of falls is important to prevent additional falls. This study analyzed whether exercise programs decrease the fear of future falls in elderly patients who have fallen previously. A randomized controlled study was performed that included 65 elderly community-dwelling subjects who had fallen in the previous year. Subjects were randomized into two groups: an exercise group (EG, n = 36) and a control group (CG, n = 29). The EG participated in three exercise sessions per week for 12 weeks. Muscle strength, balance, agility, flexibility, and muscular endurance were measured at baseline and after 12 weeks. After the 12-week exercise program, the subjects in the EG demonstrated remarkable improvement in their walking speed, balance (p = 0.003), back strength (p = 0.08), lower extremity strength (p = 0.004), and flexibility (p < 0.001). When asked whether they were afraid of falling, more participants in the EG than in the CG responded "not at all" or "a little." The 12-week exercise program described here reduced the fear of falling (p = 0.02). It also improved the balance, flexibility, and muscle strength of the participants and was associated with improved quality of life.

Long-term effects of high-intensity interval training in heart transplant recipients: A 5-year follow-up study of a randomized controlled trial.

PubMed

Yardley, Marianne; Gullestad, Lars; Bendz, Bjørn; Bjørkelund, Elisabeth; Rolid, Katrine; Arora, Satish; Nytrøen, Kari

2017-01-01

Previous studies have demonstrated that high-intensity interval training (HIT) is superior to moderate-continuous exercise in general and in cardiovascular diseases. Recently, we also found HIT safe and efficient after heart transplantation (HTx). This study reports the 5-year long-term effects. Forty-one HTx patients who had completed the previous 12-month randomized controlled trial, comparing HIT intervention with usual care, were eligible. In particular, we measured VO 2peak , muscular capacity, intravascular ultrasound, and questionnaires measuring physical and mental health. The baseline mean±SD values were as follows: age; 49.1±16.5 years, men; 68%, time since HTx: 4.1±2.2 years. Within the HIT group, initial VO 2peak increased significantly from 27.7±5.7 to 31.2±5.3 mL/kg/min. However, during the next 4 years, VO 2peak decreased to 26.0±6.2 mL/kg/min. The control group showed slightly decreasing VO 2peak values during the entire 5-year period. The HIT group reported significantly less anxiety symptoms, but there were no long-term differences in VO 2peak , muscular capacity, or cardiac allograft vasculopathy between the groups. The similar VO 2peak values correspond to our findings of similar everyday activity. Our findings suggest that intermittent periods of HIT may be necessary to maintain the initial benefits gained from the intervention. However, HIT probably reduces the burden of anxiety, which is a frequent health issue following HTx. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Oral administration of Lactobacillus paracasei NCC 2461 for the modulation of grass pollen allergic rhinitis: a randomized, placebo-controlled study during the pollen season.

PubMed

Nembrini, Chiara; Singh, Anurag; De Castro, Carlos Antonio; Mercenier, Annick; Nutten, Sophie

2015-01-01

The efficacy of Lactobacillus paracasei NCC 2461 in modulating allergic rhinitis was previously evaluated in two exploratory clinical studies. Oral administration with NCC 2461 reduced specific subjective symptoms following nasal provocation tests with controlled grass pollen allergen concentrations. Our aim was to confirm the anti-allergic effect of NCC 2461 in grass pollen allergic subjects exposed to natural doses of allergens during the pollen season. A double-blind, randomized, placebo-controlled, parallel study was conducted with 131 grass pollen allergic subjects from May to July 2012 in concomitance with the pollen season in Berlin. NCC 2461 or placebo was administered daily for an 8-week period to adult subjects with clinical history of allergic rhinitis to grass pollen, positive skin prick test and IgE to grass pollen. During the 8 weeks, symptoms and quality of life questionnaires were filled out, and plasma was collected for IgE analysis at screening and at the end of the intervention. All subjects were included within a 5-day interval, ensuring exposure to similar air pollen counts for each individual during the trial period. The results obtained show that symptoms increased with pollen loads, confirming a natural exposure to the allergen and presence of pollen-induced allergic rhinitis in the subjects. However, no significant differences were observed in allergic rhinitis symptoms scores, quality of life, or specific IgE levels between subjects receiving NCC 2461 as compared to placebo administration. In contrast to previous findings, oral administration of NCC 2461 did not show a beneficial effect on allergic rhinitis in a field trial. The influence of study design, allergen exposure and intervention window on the efficacy of NCC 2461 in modulating respiratory allergy should be further evaluated.

Cigar Box Arthroscopy: A Randomized Controlled Trial Validates Nonanatomic Simulation Training of Novice Arthroscopy Skills.

PubMed

Sandberg, Rory P; Sherman, Nathan C; Latt, L Daniel; Hardy, Jolene C

2017-11-01

The goal of this study was to validate the cigar box arthroscopy trainer (CBAT) as a training tool and then compare its effectiveness to didactic training and to another previously validated low-fidelity but anatomic model, the anatomic knee arthroscopy trainer (AKAT). A nonanatomic knee arthroscopy training module was developed at our institution. Twenty-four medical students with no prior arthroscopic or laparoscopic experience were enrolled as subjects. Eight subjects served as controls. The remaining 16 subjects were randomized to participate in 4 hours of either the CBAT or a previously validated AKAT. Subjects' skills were assessed by 1 of 2 faculty members through repeated attempts at performing a diagnostic knee arthroscopy on a cadaveric specimen. Objective scores were given using a minimally adapted version of the Basic Arthroscopic Knee Skill Scoring System. Total cost differences were calculated. Seventy-five percent of subjects in the CBAT and AKAT groups succeeded in reaching minimum proficiency in the allotted time compared with 25% in the control group (P < .05). There was no significant difference in the number of attempts to reach proficiency between the CBAT and AKAT groups. The cost to build the CBAT was $44.12, whereas the cost was $324.33 for the AKAT. This pilot study suggests the CBAT is an effective knee arthroscopy trainer that may decrease the learning curve of residents without significant cost to a residency program. This study demonstrates the need for an agreed-upon objective scoring system to properly evaluate residents and compare the effectiveness of different training tools. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Comparative effect of a new mouthrinse containing chlorhexidine, triclosan and zinc on volatile sulphur compounds: a randomized, crossover, double-blind study.

PubMed

Mendes, L; Coimbra, J; Pereira, A L; Resende, M; Pinto, M G

2016-08-01

The aims of this study were to compare the volatile sulphur compounds (VSC)-reducing effect of two commercial mouthrinses using a morning bad breath model and to assess the role of mechanical plaque control (MPC) when performed previously to mouthrinse use. Eleven volunteers with good oral health were enrolled in a double-blind, randomized, six-step crossover design study with a 7-day washout period. Two commercial mouthrinses were tested using a saline solution (NaCl 0.9%) as a negative control: one mouthrinse contained 0.05% chlorhexidine, 0.05% cetylpyridinium chloride and 0.14% zinc lactate (CHX-CPC-Zn), while the other contained 0.05% chlorhexidine, 0.15% triclosan and 0.18% zinc pidolate (CHX-triclosan-Zn). A portable sulphide monitor (Halimeter(®) ) was used for VSC quantification. Measurements were made at baseline, and 1, 3 and 5 h after rinsing. Significant differences were detected by analysis of variance. No significant differences between groups were detected at baseline. We were unable to demonstrate a significant influence of mechanical plaque control on the reduction of VSC levels when performed before mouthrinse use (P = 0.631). Both mouthrinses effectively lowered VSC levels in all test intervals (P < 0.05). No statistically significant differences were found between mouthrinses in any of the test intervals (P = 0.629, 0.069 and 0.598 at 1, 3 and 5 h). This study demonstrated that CHX-CPC-Zn and CHX-triclosan-Zn have significant and similar effects in reducing VSC levels, which persist for at least 5 h. Such effects were independent of previous MPC, which failed to improve on the results of mouthrinse use alone. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study.

PubMed

Yinger, Olivia Swedberg

2016-01-01

Children undergoing routine immunizations frequently experience severe distress, which may be improved through music therapy as procedural support. The purpose of this study was to examine effects of live, cognitive-behavioral music therapy during immunizations on (a) the behaviors of children, their parents, and their nurses; and (b) parental perceptions. Participants were children between the ages of 4 and 6 years (N = 58) who underwent immunizations, their parents (N = 62), and the nurses who administered the procedure (N = 19). Parent/child dyads were randomly assigned to receive music therapy (n = 29) or standard care (n = 29) during their immunization. Afterward, each parent rated their child's level of pain and the distress their child experienced compared to previous medical experiences. All procedures were videotaped and later viewed by trained observers, who classified child, parent, and nurse behaviors using the categories of the Child-Adult Medical Procedure Interaction Scale-Revised (CAMPIS-R). Significant differences between the music therapy and control groups were found in rates of child coping and distress behaviors and parent distress-promoting behaviors. Parents of children who received music therapy reported that their child's level of distress was less than during previous medical experiences, whereas parents of children in the control group reported that their child's level of distress was greater. No significant differences between groups were found in parents' ratings of children's pain or in rates of nurse behavior. Live, cognitive-behavioral music therapy has potential benefits for young children and their parents during immunizations. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: a Spanish Group for Research on Sarcomas study.

PubMed

García-Del-Muro, Xavier; López-Pousa, Antonio; Maurel, Joan; Martín, Javier; Martínez-Trufero, Javier; Casado, Antonio; Gómez-España, Auxiliadora; Fra, Joaquín; Cruz, Josefina; Poveda, Andrés; Meana, Andrés; Pericay, Carlos; Cubedo, Ricardo; Rubió, Jordi; De Juan, Ana; Laínez, Nuria; Carrasco, Juan Antonio; de Andrés, Raquel; Buesa, José M

2011-06-20

To assess the activity and toxicity of the combination of gemcitabine plus dacarbazine (DTIC) in patients with advanced soft tissue sarcoma (STS) in a randomized, multicenter, phase II study using DTIC alone as a control arm. Patients with previously treated advanced STS were randomly assigned to receive either fixed-dose rate gemcitabine (10 mg/m2/min) at 1800 mg/m2 followed by DTIC at 500 mg/m2 every 2 weeks, or DTIC alone at 1200 mg/m2 every 3 weeks. The primary end point of the study was progression-free rate (PFR) at 3 months. From November 2005 to September 2008, 113 patients were included. PFR at 3 months was 56% for gemcitabine plus DTIC versus 37% for DTIC alone (P = .001). Median progression-free survival was 4.2 months versus 2 months (hazard ratio [HR], 0.58; 95% CI, 0.39 to 0.86; P = .005), and median overall survival was 16.8 months versus 8.2 months (HR, 0.56; 95% CI, 0.36 to 0.90; P = .014); both favored the arm of gemcitabine plus DTIC. Gemcitabine plus DTIC was also associated with a higher objective response or higher stable disease rate than was DTIC alone (49% v 25%; P = .009). Severe toxicities were uncommon, and treatment discontinuation for toxicity was rare. Granulocytopenia was the more common serious adverse event, but febrile neutropenia was uncommon. Asthenia, emesis, and stomatitis were the most frequent nonhematologic effects. The combination of gemcitabine and DTIC is active and well tolerated in patients with STS, providing in this phase II randomized trial superior progression-free survival and overall survival than DTIC alone. This regimen constitutes a valuable therapeutic alternative for these patients.

Effect of Ginkgo biloba on visual field and contrast sensitivity in Chinese patients with normal tension glaucoma: a randomized, crossover clinical trial.

PubMed

Guo, Xinxing; Kong, Xiangbin; Huang, Rui; Jin, Ling; Ding, Xiaohu; He, Mingguang; Liu, Xing; Patel, Mehul Chimanlal; Congdon, Nathan G

2014-01-07

We evaluated the effect of ginkgo biloba extract on visual field defect and contrast sensitivity in a Chinese cohort with normal tension glaucoma. In this prospective, randomized, placebo-controlled crossover study, patients newly diagnosed with normal tension glaucoma, either in a tertiary glaucoma clinic (n = 5) or in a cohort undergoing routine general physical examinations in a primary care clinic (n = 30), underwent two 4-week phases of treatment, separated by a washout period of 8 weeks. Randomization determined whether ginkgo biloba extract (40 mg, 3 times per day) or placebo (identical-appearing tablets) was received first. Primary outcomes were change in contrast sensitivity and mean deviation on 24-2 SITA standard visual field testing, while secondary outcomes included IOP and self-reported adverse events. A total of 35 patients with mean age 63.7 (6.5) years were randomized to the ginkgo biloba extract-placebo (n = 18) or the placebo-ginkgo biloba extract (n = 17) sequence. A total of 28 patients (80.0%, 14 in each group) who completed testing did not differ at baseline in age, sex, visual field mean deviation, contrast sensitivity, IOP, or blood pressure. Changes in visual field and contrast sensitivity did not differ by treatment received or sequence (P > 0.2 for all). Power to have detected a difference in mean defect as large as previously reported was 80%. In contrast to some previous reports, ginkgo biloba extract treatment had no effect on mean defect or contrast sensitivity in this group of normal tension glaucoma patients. (http://www.chictr.org number, ChiCTR-TRC-08000724).

The SOS Suicide Prevention Program: Further Evidence of Efficacy and Effectiveness.

PubMed

Schilling, Elizabeth A; Aseltine, Robert H; James, Amy

2016-02-01

This study replicated and extended previous evaluations of the Signs of Suicide (SOS) prevention program in a high school population using a more rigorous pre-test post-test randomized control design than used in previous SOS evaluations in high schools (Aseltine and DeMartino 2004; Aseltine et al. 2007). SOS was presented to an ethnically diverse group of ninth grade students in technical high schools in Connecticut. After controlling for the pre-test reports of suicide behaviors, exposure to the SOS program was associated with significantly fewer self-reported suicide attempts in the 3 months following the program. Ninth grade students in the intervention group were approximately 64% less likely to report a suicide attempt in the past 3 months compared with students in the control group. Similarly, exposure to the SOS program resulted in greater knowledge of depression and suicide and more favorable attitudes toward (1) intervening with friends who may be exhibiting signs of suicidal intent and (2) getting help for themselves if they were depressed or suicidal. In addition, high-risk SOS participants, defined as those with a lifetime history of suicide attempt, were significantly less likely to report planning a suicide in the 3 months following the program compared to lower-risk participants. Differential attrition is the most serious limitation of the study; participants in the intervention group who reported a suicide attempt in the previous 3 months at baseline were more likely to be missing at post-test than their counterparts in the control group.

[Phase II clinical trial of nedaplatin in advanced non-small cell lung cancer].

PubMed

Xu, Rui-hua; Guan, Zhong-zhen; Jiang, Wen-qi; Huang, He; Hu, Xiao-hua; Xie, Wei-min; Li, Xing-gen; Liu, Ya-li; Pan, Liang-xi; Dai, Ai-di; Zhuang, Wu; Zhang, Chun; Ma, Zhi-yong; Wang, Jian-hua

2002-12-01

The aim of this study was to observe the efficacy and the side effects of nedaplatin in treatment of non-small cell lung cancer (NSCLC). This is a multi-center phase II clinical trial. The previously chemotherapy treated patients with NSCLC were administrated nedaplatin alone. Nedaplatin was given at 100 mg/m2, i.v., repeated every 3 weeks. The chemonaive patients with NSCLC were randomized to two groups. The combination trial group was given with nedaplatin + vindesine regimen, and the combination control group with cisplatin + vindesine. Of 138 patients, 16 were in the nedaplatin single drug group; 60 were in the combination trial group; and 62 were in the combination control group. All of the 16 cases in the single drug group, which were treated with platinum previously, achieved 12.5% of response rate. And the combination trial group and control group had a very similar response rate, which were 26.7% versus 25.8%, respectively. The incidence rates of neutropenia and anemia were similar in the two groups. But the incidence rate of thrombocytopenia was higher in the trial group than that in the control group. Nedaplatin has a possibility to result in mild nausea/vomiting. Nedaplatin is an effective platinum drug in the treatment of NSCLC, not only for no previously chemotherapy patients, but also for those patients resistant to cisplatin/carboplatin. Nedaplatin has a good clinical tolerance. And the main adverse reaction was myelosuppression, especially thrombocytopenia.

Dissociation in undergraduate students: disruptions in executive functioning.

PubMed

Giesbrecht, Timo; Merckelbach, Harald; Geraerts, Elke; Smeets, Ellen

2004-08-01

The concept of dissociation refers to disruptions in attentional control. Attentional control is an executive function. Few studies have addressed the link between dissociation and executive functioning. Our study investigated this relationship in a sample of undergraduate students (N = 185) who completed the Dissociative Experiences Scale and the Random Number Generation Task. We found that minor disruptions in executive functioning were related to a subclass of dissociative experiences, notably dissociative amnesia and the Dissociative Experiences Scale Taxon. However, the two other subscales of the Dissociative Experiences Scale, measuring depersonalization and absorption, were unrelated to executive functioning. Our findings suggest that a failure to inhibit previous responses might contribute to the pathological memory manifestations of dissociation.

Efficacy of killed whole-parasite vaccines in the prevention of leishmaniasis: a meta-analysis.

PubMed

Noazin, Sassan; Khamesipour, Ali; Moulton, Lawrence H; Tanner, Marcel; Nasseri, Kiumarss; Modabber, Farrokh; Sharifi, Iraj; Khalil, E A G; Bernal, Ivan Dario Velez; Antunes, Carlos M F; Smith, Peter G

2009-07-30

Despite decades of investigation in countries on three continents, an efficacious vaccine against Leishmania infections has not been developed. Although some indication of protection was observed in some of the controlled trials conducted with "first-generation" whole, inactivated Leishmania parasite vaccines, convincing evidence of protection was lacking. After reviewing all previously published or unpublished randomized, controlled field efficacy clinical trials of prophylactic candidate vaccines, a meta-analysis of qualified trials was conducted to evaluate whether there was some evidence of protection revealed by considering the results of all trials together. The findings indicate that the whole-parasite vaccine candidates tested do not confer significant protection against human leishmaniasis.

High-power femtosecond pulses without a modelocked laser

PubMed Central

Fu, Walter; Wright, Logan G.; Wise, Frank W.

2017-01-01

We demonstrate a fiber system which amplifies and compresses pulses from a gain-switched diode. A Mamyshev regenerator shortens the pulses and improves their coherence, enabling subsequent amplification by parabolic pre-shaping. As a result, we are able to control nonlinear effects and generate nearly transform-limited, 140-fs pulses with 13-MW peak power—an order-of-magnitude improvement over previous gain-switched diode sources. Seeding with a gain-switched diode results in random fluctuations of 2% in the pulse energy, which future work using known techniques may ameliorate. Further development may allow such systems to compete directly with sources based on modelocked oscillators in some applications while enjoying unparalleled robustness and repetition rate control. PMID:29214187

Randomized controlled trial of a book-sharing intervention in a deprived South African community: effects on carer-infant interactions, and their relation to infant cognitive and socio-emotional outcome

PubMed Central

Murray, Lynne; De Pascalis, Leonardo; Tomlinson, Mark; Vally, Zahir; Dadomo, Harold; MacLachlan, Brenda; Woodward, Charlotte; Cooper, Peter J.

2017-01-01

Background Consistent with evidence from high income countries, we previously showed that, in an informal peri-urban settlement in a low-middle income country, training parents in book-sharing with their infants benefitted infant language and attention (Vally et al., 2015). Here, we investigated whether these benefits were explained by improvements in carer-infant interactions in both book-sharing and non-book-sharing contexts. We also explored whether infant socio-emotional development benefitted from book-sharing. Methods We conducted a randomized controlled trial in Khayelitsha, South Africa. Carers of 14–16 month-old infants were randomized to 8 weeks’ training in book-sharing (n = 49) or a wait list control group (n = 42). In addition to the cognitive measures reported previously, independent assessments were made at base line and follow-up of carer-infant interactions during book-sharing and toy play. Assessments were also made, at follow-up only, of infant pro-social behaviour in a ‘help task’, and of infant imitation of doll characters’ non-social actions and an interpersonal interaction. Eighty-two carer-infant pairs (90%) were assessed at follow-up. (Trial registration ISRCTN39953901). Results Carers who received the training showed significant improvements in book-sharing interactions (sensitivity, elaborations, reciprocity), and, to a smaller extent, in toy-play interactions (sensitivity). Infants in the intervention group showed a significantly higher rate of pro-social behaviour, and tended to show more frequent imitation of the interpersonal interaction. Improvements in carer behaviour during book-sharing, but not during toy play, mediated intervention effects on all infant cognitive outcomes, and tended to mediate intervention effects on infant interpersonal imitation. Conclusions Training in book sharing, a simple, inexpensive intervention that has been shown to benefit infant cognitive development in a low-middle income country, also shows promise for improving infant socio-emotional outcomes in this context. Benefits are mediated by improvements in carer-infant interactions, particularly in book-sharing contexts. PMID:27465028

Randomized controlled trial of a book-sharing intervention in a deprived South African community: effects on carer-infant interactions, and their relation to infant cognitive and socioemotional outcome.

PubMed

Murray, Lynne; De Pascalis, Leonardo; Tomlinson, Mark; Vally, Zahir; Dadomo, Harold; MacLachlan, Brenda; Woodward, Charlotte; Cooper, Peter J

2016-12-01

Consistent with evidence from high-income countries (HICs), we previously showed that, in an informal peri-urban settlement in a low-middle income country, training parents in book sharing with their infants benefitted infant language and attention (Vally, Murray, Tomlinson, & Cooper, ). Here, we investigated whether these benefits were explained by improvements in carer-infant interactions in both book-sharing and non-book-sharing contexts. We also explored whether infant socioemotional development benefitted from book sharing. We conducted a randomized controlled trial in Khayelitsha, South Africa. Carers of 14-16-month-old infants were randomized to 8 weeks' training in book sharing (n = 49) or a wait-list control group (n = 42). In addition to the cognitive measures reported previously, independent assessments were made at base line and follow-up of carer-infant interactions during book sharing and toy play. Assessments were also made, at follow-up only, of infant prosocial behaviour in a 'help task', and of infant imitation of doll characters' nonsocial actions and an interpersonal interaction. Eighty-two carer-infant pairs (90%) were assessed at follow-up. (Trial registration ISRCTN39953901). Carers who received the training showed significant improvements in book-sharing interactions (sensitivity, elaborations, reciprocity), and, to a smaller extent, in toy-play interactions (sensitivity). Infants in the intervention group showed a significantly higher rate of prosocial behaviour, and tended to show more frequent imitation of the interpersonal interaction. Improvements in carer behaviour during book sharing, but not during toy play, mediated intervention effects on all infant cognitive outcomes, and tended to mediate intervention effects on infant interpersonal imitation. Training in book sharing, a simple, inexpensive intervention that has been shown to benefit infant cognitive development in a low-middle income country, also shows promise for improving infant socioemotional outcomes in this context. Benefits are mediated by improvements in carer-infant interactions, particularly in book-sharing contexts. © 2016 Association for Child and Adolescent Mental Health.

The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients.

PubMed

Griva, Konstadina; Mooppil, Nandakumar; Seet, Penny; Krishnan, Deby Sarojiuy Pala; James, Hayley; Newman, Stanton P

2011-01-28

Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care. This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change. The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients.

Rotigotine transdermal patch in Chinese patients with advanced Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study.

PubMed

Zhang, Zhen-Xin; Liu, Chun-Feng; Tao, En-Xiang; Shao, Ming; Liu, Yi-Ming; Wang, Jian; Asgharnejad, Mahnaz; Xue, Hai-Bo; Surmann, Erwin; Bauer, Lars

2017-11-01

Rotigotine was demonstrated to be efficacious and well-tolerated in three placebo-controlled studies (CLEOPATRA-PD/PREFER/SP921) of patients with advanced-stage Parkinson's disease (PD), most of whom were Caucasian. This multicenter phase 3 study (SP1037; NCT01646255) was the first to investigate the efficacy and safety of rotigotine in Chinese patients with advanced-stage PD. Chinese patients with PD, inadequately controlled on levodopa (stable dose ≥200 mg/day), with ≥2.5 h/day "off" time, and Hoehn & Yahr stage 2-4, were randomized 1:1 to receive transdermal rotigotine or placebo, titrated over ≤7 weeks, maintained at optimal/maximum dose (4-16 mg/24 h) for 12 weeks. Primary efficacy variable: mean change in absolute "off" time (according to patient diaries) from baseline to end of maintenance. Safety variables included adverse events (AEs) and discontinuations due to AEs. 346 patients were randomized and 89.9% completed the study (87.8% placebo; 92.0% rotigotine). All were Chinese (58.7% male; mean ± SD age: 62.2 ± 8.9 years; mean ± SD time since PD diagnosis: 6.62 ± 3.70 years). Rotigotine significantly reduced "off" time vs placebo (LS mean [95% CI] treatment difference: -1.20 h/day [-1.83, -0.57]; p = 0.0002), and resulted in more responders (≥30% decrease in "off" time: 36.9% placebo; 48.8% rotigotine; p = 0.0269). AEs were reported for 86 (50.0%) placebo- and 103 (59.2%) rotigotine-treated patients; 15 discontinued due to AEs (placebo 7; rotigotine 8). The most common AEs (≥5%) were dizziness, nausea, pruritus, and dyskinesia. Rotigotine was efficacious in Chinese patients with advanced-stage PD as add-on therapy to levodopa, significantly reducing "off" time vs placebo; the treatment difference was similar to that observed in previous studies of mainly Caucasian patients. Rotigotine was generally well-tolerated and had a similar AE profile to those observed in previous studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

A novel iterative mixed model to remap three complex orthopedic traits in dogs

PubMed Central

Huang, Meng; Hayward, Jessica J.; Corey, Elizabeth; Garrison, Susan J.; Wagner, Gabriela R.; Krotscheck, Ursula; Hayashi, Kei; Schweitzer, Peter A.; Lust, George; Boyko, Adam R.; Todhunter, Rory J.

2017-01-01

Hip dysplasia (HD), elbow dysplasia (ED), and rupture of the cranial (anterior) cruciate ligament (RCCL) are the most common complex orthopedic traits of dogs and all result in debilitating osteoarthritis. We reanalyzed previously reported data: the Norberg angle (a quantitative measure of HD) in 921 dogs, ED in 113 cases and 633 controls, and RCCL in 271 cases and 399 controls and their genotypes at ~185,000 single nucleotide polymorphisms. A novel fixed and random model with a circulating probability unification (FarmCPU) function, with marker-based principal components and a kinship matrix to correct for population stratification, was used. A Bonferroni correction at p<0.01 resulted in a P< 6.96 ×10−8. Six loci were identified; three for HD and three for RCCL. An associated locus at CFA28:34,369,342 for HD was described previously in the same dogs using a conventional mixed model. No loci were identified for RCCL in the previous report but the two loci for ED in the previous report did not reach genome-wide significance using the FarmCPU model. These results were supported by simulation which demonstrated that the FarmCPU held no power advantage over the linear mixed model for the ED sample but provided additional power for the HD and RCCL samples. Candidate genes for HD and RCCL are discussed. When using FarmCPU software, we recommend a resampling test, that a positive control be used to determine the optimum pseudo quantitative trait nucleotide-based covariate structure of the model, and a negative control be used consisting of permutation testing and the identical resampling test as for the non-permuted phenotypes. PMID:28614352

Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial.

PubMed

Nash, Peter; Kirkham, Bruce; Okada, Masato; Rahman, Proton; Combe, Benard; Burmester, Gerd-Ruediger; Adams, David H; Kerr, Lisa; Lee, Chin; Shuler, Catherine L; Genovese, Mark

2017-06-10

Patients who have had inadequate response to tumour necrosis factor inhibitors have fewer treatment options and are generally more treatment refractory to subsequent therapeutic interventions than previously untreated patients. We report the efficacy and safety of ixekizumab, a monoclonal antibody that selectively targets interleukin-17A, in patients with active psoriatic arthritis and previous inadequate response to tumour necrosis factor inhibitors. In this double-blind, multicentre, randomised, placebo-controlled, phase 3 study (SPIRIT-P2), patients were recruited from 109 centres across ten countries in Asia, Australia, Europe, and North America. Patients were aged 18 years or older, had a confirmed diagnosis of psoriatic arthritis for at least 6 months, and had a previous inadequate response, distinguished by being refractory to therapy or had loss of efficacy, or were intolerant to tumour necrosis factor inhibitors. Patients were randomly assigned (1:1:1) by a computer-generated random sequence to receive a subcutaneous injection of 80 mg ixekizumab every 4 weeks or every 2 weeks after a 160 mg starting dose or placebo. The primary endpoint was the proportion of patients who attained at least 20% improvement in the American College of Rheumatology response criteria (ACR-20) at week 24. This study is registered with ClinicalTrials.gov, number NCT02349295. Between March 3, 2015, to March 22, 2016, 363 patients were randomly assigned to placebo (n=118), ixekizumab every 4 weeks (n=122), or ixekizumab every 2 weeks (n=123). At week 24, a higher proportion of patients attained ACR-20 with ixekizumab every 4 weeks (65 [53%] patients; effect size vs placebo 33·8% [95% CI 22·4-45·2]; p<0·0001) and ixekizumab every 2 weeks (59 [48%] patients; 28.5% [17·1-39.8]; p<0·0001) than did patients with placebo (23 [20%] patients). Up to week 24, serious adverse events were reported in three (3%) patients with ixekizumab every 4 weeks, eight (7%) with ixekizumab every 2 weeks, and four (3%) with placebo; no deaths were reported. Infections were reported in 47 (39%) patients with ixekizumab every 4 weeks, 47 (38%) with ixekizumab every 2 weeks, and 35 (30%) with placebo. Three (2%) serious infections, all in patients in the ixekizumab every 2 weeks group, were reported. Both the 2-week and 4-week ixekizumab dosing regimens improved the signs and symptoms of patients with active psoriatic arthritis and who had previously inadequate response to tumour necrosis factor inhibitors, with a safety profile consistent with previous studies investigating ixekizumab. Eli Lilly and Company. Copyright © 2017 Elsevier Ltd. All rights reserved.

A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery.

PubMed

Prochaska, Judith J; Delucchi, Kevin; Hall, Sharon M

2004-12-01

This meta-analysis examined outcomes of smoking cessation interventions evaluated in 19 randomized controlled trials with individuals in current addictions treatment or recovery. Smoking and substance use outcomes at posttreatment and long-term follow-up (> or = 6 months) were summarized with random effects models. Intervention effects for smoking cessation were significant at posttreatment and comparable for participants in addictions treatment and recovery; however, intervention effects for smoking cessation were nonsignificant at long-term follow-up. Smoking cessation interventions provided during addictions treatment were associated with a 25% increased likelihood of long-term abstinence from alcohol and illicit drugs. Short-term smoking cessation effects look promising, but innovative strategies are needed for long-term cessation. Contrary to previous concerns, smoking cessation interventions during addictions treatment appeared to enhance rather than compromise long-term sobriety. Copyright 2004 APA.

The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients

PubMed Central

2011-01-01

Background Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care. Methods/Design This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change. Discussion The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients. Trial registration Current Controlled Trials ISRTN31434033 PMID:21272382

Intensive glycemic control is not associated with fractures or falls in the ACCORD randomized trial.

PubMed

Schwartz, Ann V; Margolis, Karen L; Sellmeyer, Deborah E; Vittinghoff, Eric; Ambrosius, Walter T; Bonds, Denise E; Josse, Robert G; Schnall, Adrian M; Simmons, Debra L; Hue, Trisha F; Palermo, Lisa; Hamilton, Bruce P; Green, Jennifer B; Atkinson, Hal H; O'Connor, Patrick J; Force, Rex W; Bauer, Douglas C

2012-07-01

Older adults with type 2 diabetes are at high risk of fractures and falls, but the effect of glycemic control on these outcomes is unknown. To determine the effect of intensive versus standard glycemic control, we assessed fractures and falls as outcomes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) randomized trial. ACCORD participants were randomized to intensive or standard glycemia strategies, with an achieved median A1C of 6.4 and 7.5%, respectively. In the ACCORD BONE ancillary study, fractures were assessed at 54 of the 77 ACCORD clinical sites that included 7,287 of the 10,251 ACCORD participants. At annual visits, 6,782 participants were asked about falls in the previous year. During an average follow-up of 3.8 (SD 1.3) years, 198 of 3,655 participants in the intensive glycemia and 189 of 3,632 participants in the standard glycemia group experienced at least one nonspine fracture. The average rate of first nonspine fracture was 13.9 and 13.3 per 1,000 person-years in the intensive and standard groups, respectively (hazard ratio 1.04 [95% CI 0.86-1.27]). During an average follow-up of 2.0 years, 1,122 of 3,364 intensive- and 1,133 of 3,418 standard-therapy participants reported at least one fall. The average rate of falls was 60.8 and 55.3 per 100 person-years in the intensive and standard glycemia groups, respectively (1.10 [0.84-1.43]). Compared with standard glycemia, intensive glycemia did not increase or decrease fracture or fall risk in ACCORD.

Effect Evaluation of a Randomized Trial to Reduce Infectious Illness and Illness-related Absenteeism Among Schoolchildren: The Hi Five Study.

PubMed

Denbæk, Anne Maj; Andersen, Anette; Bonnesen, Camilla Thørring; Laursen, Bjarne; Ersbøll, Annette Kjær; Due, Pernille; Johansen, Anette

2018-01-01

Previous school-based hand hygiene interventions have reported to successfully reduce infectious illness among schoolchildren. But few studies have tested the effect in large populations with adequate statistical power and analyses. The aim of this study was to evaluate whether a school-based multicomponent intervention to improve handwashing among schoolchildren, the Hi Five study, succeeded in reducing infectious illness and illness-related absenteeism in schools. The Hi Five study was a three-armed cluster-randomized controlled trial involving 43 randomly selected Danish schools; two intervention arms involving 14 schools each, and 15 control schools. Infectious illness days, infectious illness episodes and illness-related absenteeism were estimated in multilevel regressions, based on available cases of text messages answered by parents and based on questionnaire data reported by schoolchildren, respectively. At follow-up, children in the intervention schools did not differ from the control schools in number of illness days [odds ratio (OR)I-arm I: 0.91 (0.77-1.07) and ORI-arm II: 0.94 (0.79-1.12)] and illness episodes [ORI-arm I: 0.95 (0.81-1.11) and ORI-arm II: 0.98 (0.84-1.16)] or in reporting illness-related absenteeism [ORI-arm I: 1.09 (0.83-1.43) & ORI-arm II: 1.06 (0.81-1.40)]. The multicomponent Hi Five intervention achieved no difference in the number of illness days, illness episodes or illness-related absenteeism among children in intervention schools compared with control schools. It is noteworthy that one of the main components in the intervention, a mandatory daily handwashing before lunch, was only implemented by 1 of 3 of teachers in intervention schools.

Does flushing the endometrial cavity with follicular fluid after oocyte retrieval affect pregnancy rates in subfertile women undergoing intracytoplasmic sperm injection? A randomized controlled trial.

PubMed

Hashish, N M; Badway, H S; Abdelmoty, H I; Mowafy, A; Youssef, M A F M

2014-05-01

Follicular fluid of mature oocytes is rich in growth factors and cytokines that may exert paracrine and autocrine effects on implantation. The aim of this study was to investigate if flushing the endometrial cavity with follicular fluid after oocyte retrieval improved pregnancy rates in subfertile women undergoing intracytoplasmic sperm injection (ICSI). One hundred subfertile women undergoing ICSI between April 2012 and September 2012 at the centre for reproductive medicine, Cairo University, Egypt were enrolled in this open label, parallel randomized controlled study. Patients were randomized into two groups at the start of treatment using a computer-generated programme and sealed opaque envelopes: the follicular fluid group (n=50) and the control group (n=50). Inclusion criteria were: age 20-38 years; basal follicle-stimulating hormone <10mIU/ml; body mass index <35kg/m(2); and ostradiol >1000pg/ml and <4000pg/ml on the day of human chorionic gonadotrophin administration. Exclusion criteria were: evidence of endometriosis; uterine myoma; hydrosalpinges; endocrinological disorders; history of implantation failure in previous in-vitro fertilization/ICSI cycles; and severe male factor infertility. Clinical pregnancy and implantation rates were higher in the follicular fluid group compared with the control group [354% (17/48) vs 319% (15/47); p=0718] and (18.6% vs 11.3%; p=0.153), respectively. However, the difference was not statistically significant. Flushing the endometrial cavity with follicular fluid after oocyte retrieval neither improved nor adversely affected clinical pregnancy and implantation rates in subfertile women undergoing ICSI. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A randomized controlled trial of a nurse-led case management programme for hospital-discharged older adults with co-morbidities

PubMed Central

Chow, Susan Ka Yee; Wong, Frances Kam Yuet

2014-01-01

Aim To examine the effects of a nurse-led case management programme for hospital-discharged older adults with co-morbidities. Background The most significant chronic conditions today involve diseases of the cardiovascular, respiratory, endocrine and renal systems. Previous studies have suggested that a nurse-led case management approach using either telephone follow-ups or home visits was able to improve clinical and patient outcomes for patients having a single, chronic disease, while the effects for older patients having at least two long-term conditions are unknown. A self-help programme using motivation and empowerment approaches is the framework of care in the study. Design Randomized controlled trial. Method The study was conducted from 2010–2012. Older patients having at least two chronic diseases were included for analysis. The participants were randomized into three arms: two study groups and one control group. Data were collected at baseline and at 4 and 12 weeks later. Results Two hundred and eighty-one patients completed the study. The interventions demonstrated significant differences in hospital readmission rates within 84 days post discharge. The two intervention groups had lower readmission rates than the control group. Patients in the two study arms had significantly better self-rated health and self-efficacy. There was significant difference between the groups in the physical composite score, but no significant difference in mental component score in SF-36 scale. Conclusion The postdischarge interventions led by the nurse case managers on self-management of disease using the empowerment approach were able to provide effective clinical and patient outcomes for older patients having co-morbidities. PMID:24617755

A randomized controlled trial of cognitive-behavioral stress management in breast cancer: survival and recurrence at 11-year follow-up.

PubMed

Stagl, Jamie M; Lechner, Suzanne C; Carver, Charles S; Bouchard, Laura C; Gudenkauf, Lisa M; Jutagir, Devika R; Diaz, Alain; Yu, Qilu; Blomberg, Bonnie B; Ironson, Gail; Glück, Stefan; Antoni, Michael H

2015-11-01

Non-metastatic breast cancer patients often experience psychological distress which may influence disease progression and survival. Cognitive-behavioral stress management (CBSM) improves psychological adaptation and lowers distress during breast cancer treatment and long-term follow-ups. We examined whether breast cancer patients randomized to CBSM had improved survival and recurrence 8-15 years post-enrollment. From 1998 to 2005, women (N = 240) 2-10 weeks post-surgery for non-metastatic Stage 0-IIIb breast cancer were randomized to a 10-week, group-based CBSM intervention (n = 120) or a 1-day psychoeducational seminar control (n = 120). In 2013, 8-15 years post-study enrollment (11-year median), recurrence and survival data were collected. Cox Proportional Hazards Models and Weibull Accelerated Failure Time tests were used to assess group differences in all-cause mortality, breast cancer-specific mortality, and disease-free interval, controlling for biomedical confounders. Relative to the control, the CBSM group was found to have a reduced risk of all-cause mortality (HR = 0.21; 95 % CI [0.05, 0.93]; p = .040). Restricting analyses to women with invasive disease revealed significant effects of CBSM on breast cancer-related mortality (p = .006) and disease-free interval (p = .011). CBSM intervention delivered post-surgery may provide long-term clinical benefit for non-metastatic breast cancer patients in addition to previously established psychological benefits. Results should be interpreted with caution; however, the findings contribute to the limited evidence regarding physical benefits of psychosocial intervention post-surgery for non-metastatic breast cancer. Additional research is necessary to confirm these results and investigate potential explanatory mechanisms, including physiological pathways, health behaviors, and treatment adherence changes.

Impact of a school-based intervention to promote fruit intake: a cluster randomized controlled trial.

PubMed

Rosário, R; Araújo, A; Padrão, P; Lopes, O; Moreira, A; Abreu, S; Vale, S; Pereira, B; Moreira, P

2016-07-01

There is evidence that fruit consumption among school children is below the recommended levels. This study aims to examine the effects of a dietary education intervention program me, held by teachers previously trained in nutrition, on the consumption of fruit as a dessert at lunch and dinner, among children 6-12 years old. This is a randomized trial with the schools as the unit of randomisation. A total of 464 children (239 female, 6-12years) from seven elementary schools participated in this cluster randomized controlled trial. Three schools were allocated to the intervention and four to the control group. For the intervention schools, we delivered professional development training to school teachers (12 sessions of 3 h each). The training provided information about nutrition, healthy eating, the importance of drinking water and healthy cooking activities. After each session, teachers were encouraged to develop classroom activities focused on the learned topics. Sociodemographic was assessed at baseline and anthropometric, dietary intake and physical activity assessments were performed at baseline and at the end of the intervention. Dietary intake was evaluated by a 24-h dietary recall and fruit consumption as a dessert was gathered at lunch and dinner. Intervened children reported a significant higher intake in the consumption of fruit compared to the controlled children at lunch (P = 0.001) and at dinner (P = 0.012), after adjusting for confounders. Our study provides further support for the success of intervention programmes aimed at improving the consumption of fruit as a dessert in children. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Outcomes from a randomized controlled trial of a multi-component alcohol use preventive intervention for urban youth: project northland Chicago.

PubMed

Komro, Kelli A; Perry, Cheryl L; Veblen-Mortenson, Sara; Farbakhsh, Kian; Toomey, Traci L; Stigler, Melissa H; Jones-Webb, Rhonda; Kugler, Kari C; Pasch, Keryn E; Williams, Carolyn L

2008-04-01

The goal of this group-randomized trial was to test the effectiveness of an adapted alcohol use preventive intervention for urban, low-income and multi-ethnic settings. Sixty-one public schools in Chicago were recruited to participate, were grouped into neighborhood study units and assigned randomly to intervention or 'delayed program' control condition. The study sample (n = 5812 students) was primarily African American, Hispanic and low-income. Students, beginning in sixth grade (age 12 years), received 3 years of intervention strategies (curricula, family interventions, youth-led community service projects, community organizing). Students participated in yearly classroom-based surveys to measure their alcohol use and related risk and protective factors. Additional evaluation components included a parent survey, a community leader survey and alcohol purchase attempts. Overall, the intervention, compared with a control condition receiving 'prevention as usual', was not effective in reducing alcohol use, drug use or any hypothesized mediating variables (i.e. related risk and protective factors). There was a non-significant trend (P = 0.066) that suggested the ability to purchase alcohol by young-appearing buyers was reduced in the intervention communities compared to the control communities, but this could be due to chance. Secondary outcome analyses to assess the effects of each intervention component indicated that the home-based programs were associated with reduced alcohol, marijuana and tobacco use combined (P = 0.01), with alcohol use alone approaching statistical significance (P = 0.06). Study results indicate the importance of conducting evaluations of previously validated programs in contexts that differ from the original study sample. Also, the findings highlight the need for further research with urban, low-income adolescents from different ethnic backgrounds to identify effective methods to prevent and reduce alcohol use.

Efficacy of Topical Alpha Ointment (Containing Natural Henna) Compared to Topical Hydrocortisone (1%) in the Healing of Radiation-Induced Dermatitis in Patients with Breast Cancer: A Randomized Controlled Clinical Trial

PubMed Central

Ansari, Mansour; Dehsara, Farzin; Mosalaei, Ahmad; Omidvari, Shapour; Ahmadloo, Niloofar; Mohammadianpanah, Mohammad

2013-01-01

Background: This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients. Methods: The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy. Results: The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm2 in the control arm and 17.02 cm2 in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients’ complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully. Conclusion: Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer. Trial Registration Numbers: IRCT201206099979N1, ACTRN12612000837820 PMID:24293782

Efficacy of topical alpha ointment (containing natural henna) compared to topical hydrocortisone (1%) in the healing of radiation-induced dermatitis in patients with breast cancer: a randomized controlled clinical trial.

PubMed

Ansari, Mansour; Farzin, Dehsara; Mosalaei, Ahmad; Omidvari, Shapour; Ahmadloo, Niloofar; Mohammadianpanah, Mohammad

2013-12-01

This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients. The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy. The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm(2) in the control arm and 17.02 cm(2) in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients' complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer. IRCT201206099979N1, ACTRN12612000837820.

Survival in Malnourished Older Patients Receiving Post-Discharge Nutritional Support; Long-Term Results of a Randomized Controlled Trial.

PubMed

Neelemaat, F; van Keeken, S; Langius, J A E; de van der Schueren, M A E; Thijs, A; Bosmans, J E

2017-01-01

Previous analyses have shown that a post-discharge individualized nutritional intervention had positive effects on body weight, lean body mass, functional limitations and fall incidents in malnourished older patients. However, the impact of this intervention on survival has not yet been studied. The objective of this randomized controlled study was to examine the effect of a post-discharge individualized nutritional intervention on survival in malnourished older patients. Malnourished older patients, aged ≥ 60 years, were randomized during hospitalization to a three-months post-discharge nutritional intervention group (protein and energy enriched diet, oral nutritional supplements, vitamin D3/calcium supplement and telephone counseling by a dietitian) or to a usual care regimen (control group). Survival data were collected 4 years after enrollment. Survival analyses were performed using intention-to-treat analysis by Log-rank tests and Cox regression adjusted for confounders. The study population consisted of 94 men (45%) and 116 women with a mean age of 74.5 (SD 9.5) years. There were no statistically significant differences in baseline characteristics. Survival data was available in 208 out of 210 patients. After 1 and 4 years of follow-up, survival rates were respectively 66% and 29% in the intervention group (n=104) and 73% and 30% in the control group (n=104). There were no statistically significant differences in survival between the two groups 1 year (HR= 0.933, 95% CI=0.675-1.289) and 4 years after enrollment (HR=0.928, 95% CI=0.671-1.283). The current study failed to show an effect of a three-months post-discharge multi-component nutritional intervention in malnourished older patients on long-term survival, despite the positive effects on short-term outcome such as functional limitations and falls.

Effect of patient navigation on colorectal cancer screening in a community-based randomized controlled trial of urban African American adults

PubMed Central

Phelan-Emrick, Darcy F.; Pollack, Craig E.; Markakis, Diane; Wenzel, Jennifer; Ahmed, Saifuddin; Garza, Mary A.; Shapiro, Gary R.; Bone, Lee R.; Johnson, Lawrence B.; Ford, Jean G.

2015-01-01

Purpose In recent years, colorectal cancer (CRC) screening rates have increased steadily in the USA, though racial and ethnic disparities persist. In a community-based randomized controlled trial, we investigated the effect of patient navigation on increasing CRC screening adherence among older African Americans. Methods Participants in the Cancer Prevention and Treatment Demonstration were randomized to either the control group, receiving only printed educational materials (PEM), or the intervention arm where they were assigned a patient navigator in addition to PEM. Navigators assisted participants with identifying and overcoming screening barriers. Logistic regression analyses were used to assess the effect of patient navigation on CRC screening adherence. Up-to-date with screening was defined as self-reported receipt of colonoscopy/sigmoidoscopy in the previous 10 years or fecal occult blood testing (FOBT) in the year prior to the exit interview. Results Compared with controls, the intervention group was more likely to report being up-to-date with CRC screening at the exit interview (OR 1.55, 95 % CI 1.07–2.23), after adjusting for select demographics. When examining the screening modalities separately, the patient navigator increased screening for colonoscopy/sigmoidoscopy (OR 1.53, 95 % CI 1.07–2.19), but not FOBT screening. Analyses of moderation revealed stronger effects of navigation among participants 65–69 years and those with an adequate health literacy level. Conclusions In a population of older African Americans adults, patient navigation was effective in increasing the likelihood of CRC screening. However, more intensive navigation may be necessary for adults over 70 years and individuals with low literacy levels. PMID:25516073

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

PubMed Central

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

2018-01-01

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

Effect of a pragmatic, cluster-randomized controlled trial on patient experience with care: The Transforming Outcomes for Patients through Medical home Evaluation and reDesign (TOPMED) study

PubMed Central

Dorr, David A.; Anastas, Tracy; Ramsey, Katrina; Wagner, Jesse; Sachdeva, Bhavaya; Michaels, LeAnn; Fagnan, Lyle

2016-01-01

Background Health reform programs like the Patient-Centered Medical Home (PCMH) are intended to improve the Triple Aim. Previous studies on PCMHs have shown mixed effects, but High Value Elements (HVEs) are expected to improve the Triple Aim. Objective To understand whether focusing on high value elements (HVEs) would improve patient experience with care. Methods Eight clinics were cluster-randomized in a year-long trial. Both arms received practice facilitation, IT-based reporting, and financial incentives. Intervention practices were encouraged to choose HVEs for QI goals. To assess patient experience, 1,597 Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys were sent pre- and post-trial to a stratified random sample of patients. Difference in difference multivariate analysis was used to compare patient responses from intervention and control practices, adjusting for confounders. Results The response rate was 43% (n=686). Non-respondent analysis showed no difference between arms, although differences were seen by risk status and age. The overall difference in difference was 2.8%, favoring the intervention. The intervention performed better in 9 of 11 composites. The intervention performed significantly better in Follow-up on test results (p=.091) and Patients’ rating of the provider (p=.091), while the control performed better in Access to care (p=.093). Both arms also had decreases, including 4 of 11 composites for the intervention, and 8 of 11 for the control. Discussion Practices that targeted HVEs showed significantly more improvement in patient experience of care. However, contemporaneous trends may have affected results, leading to declines in patient experience in both arms. PMID:27116107

Transfusion of irradiated red blood cell units with a potassium adsorption filter: A randomized controlled trial.

PubMed

Cid, Joan; Villegas, Vanessa; Carbassé, Gloria; Alba, Cristina; Perea, Dolores; Lozano, Miguel

2016-05-01

The irradiation of red blood cells (RBCs) causes damage of the RBC membrane with increased potassium (K) leak during storage compared with nonirradiated RBC units of similar age. A previous in vitro study showed a mean reduction of K of 94 ± 5% with a potassium adsorption filter (PAF). A prospective, single-center, nonblinded, randomized controlled trial (RCT) was designed to evaluate the safety and efficacy of transfusing irradiated RBC units with the PAF. Patients 18 years of age or older who received irradiated RBC units due to chemotherapy-induced anemia were randomly assigned to receive irradiated RBC units with the PAF (PAF group) or with the standard blood infusion set (control group). Primary outcome measures were safety and efficacy of the PAF (absolute change in hemoglobin [Hb] and K, respectively, in patient's blood values after transfusing the irradiated RBC units with or without the PAF). A total of 63 irradiated RBC units were transfused to 17 patients in the control group, and a total of 56 irradiated RBC units were transfused to 13 patients in the PAF group. The absolute change of Hb (9.3 ± 6.3 g/L vs. 8.1 ± 5.8 g/L; p = 0.3) and the absolute change of K (-0.01 ± 0.4 mmol/L vs. -0.01 ± 0.3 mmol/L; p = 0.2) were comparable between the two groups of the trial. The transfusion of 1 irradiated RBC unit with the PAF was as safe and efficacious as the transfusion of 1 irradiated RBC unit with the standard blood infusion set in patients with chemotherapy-induced anemia. © 2016 AABB.

Daily potassium intake and sodium-to-potassium ratio in the reduction of blood pressure: a meta-analysis of randomized controlled trials.

PubMed

Binia, Aristea; Jaeger, Jonathan; Hu, Youyou; Singh, Anurag; Zimmermann, Diane

2015-08-01

To evaluate the efficacy of daily potassium intake on decreasing blood pressure in non-medicated normotensive or hypertensive patients, and to determine the relationship between potassium intake, sodium-to-potassium ratio and reduction in blood pressure. Mixed-effect meta-analyses and meta-regression models. Medline and the references of previous meta-analyses. Randomized controlled trials with potassium supplementation, with blood pressure as the primary outcome, in non-medicated patients. Fifteen randomized controlled trials of potassium supplementation in patients without antihypertensive medication were selected for the meta-analyses (917 patients). Potassium supplementation resulted in reduction of SBP by 4.7 mmHg [95% confidence interval (CI) 2.4-7.0] and DBP by 3.5 mmHg (95% CI 1.3-5.7) in all patients. The effect was found to be greater in hypertensive patients, with a reduction of SBP by 6.8 mmHg (95% CI 4.3-9.3) and DBP by 4.6 mmHg (95% CI 1.8-7.5). Meta-regression analysis showed that both increased daily potassium excretion and decreased sodium-to-potassium ratio were associated with blood pressure reduction (P < 0.05). Increased total daily potassium urinary excretion from 60 to 100 mmol/day and decrease of sodium-to-potassium ratio were shown to be necessary to explain the estimated effect. Potassium supplementation is associated with reduction of blood pressure in patients who are not on antihypertensive medication, and the effect is significant in hypertensive patients. The reduction in blood pressure significantly correlates with decreased daily urinary sodium-to-potassium ratio and increased urinary potassium. Patients with elevated blood pressure may benefit from increased potassium intake along with controlled or decreased sodium intake.

Effect of patient navigation on colorectal cancer screening in a community-based randomized controlled trial of urban African American adults.

PubMed

Horne, Hisani N; Phelan-Emrick, Darcy F; Pollack, Craig E; Markakis, Diane; Wenzel, Jennifer; Ahmed, Saifuddin; Garza, Mary A; Shapiro, Gary R; Bone, Lee R; Johnson, Lawrence B; Ford, Jean G

2015-02-01

In recent years, colorectal cancer (CRC) screening rates have increased steadily in the USA, though racial and ethnic disparities persist. In a community-based randomized controlled trial, we investigated the effect of patient navigation on increasing CRC screening adherence among older African Americans. Participants in the Cancer Prevention and Treatment Demonstration were randomized to either the control group, receiving only printed educational materials (PEM), or the intervention arm where they were assigned a patient navigator in addition to PEM. Navigators assisted participants with identifying and overcoming screening barriers. Logistic regression analyses were used to assess the effect of patient navigation on CRC screening adherence. Up-to-date with screening was defined as self-reported receipt of colonoscopy/sigmoidoscopy in the previous 10 years or fecal occult blood testing (FOBT) in the year prior to the exit interview. Compared with controls, the intervention group was more likely to report being up-to-date with CRC screening at the exit interview (OR 1.55, 95 % CI 1.07-2.23), after adjusting for select demographics. When examining the screening modalities separately, the patient navigator increased screening for colonoscopy/sigmoidoscopy (OR 1.53, 95 % CI 1.07-2.19), but not FOBT screening. Analyses of moderation revealed stronger effects of navigation among participants 65-69 years and those with an adequate health literacy level. In a population of older African Americans adults, patient navigation was effective in increasing the likelihood of CRC screening. However, more intensive navigation may be necessary for adults over 70 years and individuals with low literacy levels.

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

PubMed

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

2017-01-01

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

Mirror therapy in chronic stroke survivors with severely impaired upper limb function: a randomized controlled trial.

PubMed

Colomer, Carolina; NOé, Enrique; Llorens, Roberto

2016-06-01

Mirror therapy (MT) has been proposed to improve the motor function of chronic individuals with stroke with mild to moderate impairment. With regards to severe upper limb paresis, MT has shown to provide limited motor improvement in the acute or sub-acute phase. However, no previous research has described the effects of MT in chronic individuals with stroke with severely impaired upper limb function. The aim of this study was to determine the effectiveness of MT on chronic stroke survivors with severe upper-limb impairment in comparison with passive mobilization. A randomized controlled trial. Rehabilitative outpatient unit. A total of 31 chronic subjects poststroke with severely impaired upper limb function were randomly assigned to either an experimental group (N.=15), or a control group (N.=16). Twenty-four intervention sessions were performed for both groups. Each session included 45-minute period of MT (experimental group) or passive mobilization (control group), administered three days a week. Participants were assessed before and after the intervention with the Wolf Motor Function Test, the Fugl-Meyer Assessment, and the Nottingham Sensory Assessment. Improvement in motor function was observed in both groups on the time (P=0.002) and ability (P=0.001) subscales of the Wolf Motor Function Test. No differences were detected in kinesthesis or stereognosis. However, the experimental group showed a significant improvement in tactile sensation that was mainly observed as an increased sensitivity to light touches. In comparison with passive mobilization, MT in chronic stroke survivors with severely impaired upper-limb function may provide a limited but positive effect on light touch sensitivity while providing similar motor improvement. MT is a therapeutic approach that can be used in the rehabilitation of severely impaired upper limb in chronic stroke survivors, specifically to address light touch sensitivity deficits.

Genetic variation in the ADIPOQ gene, adiponectin concentrations and risk of colorectal cancer: a Mendelian Randomization analysis using data from three large cohort studies.

PubMed

Nimptsch, Katharina; Song, Mingyang; Aleksandrova, Krasimira; Katsoulis, Michail; Freisling, Heinz; Jenab, Mazda; Gunter, Marc J; Tsilidis, Konstantinos K; Weiderpass, Elisabete; Bueno-De-Mesquita, H Bas; Chong, Dawn Q; Jensen, Majken K; Wu, Chunsen; Overvad, Kim; Kühn, Tilman; Barrdahl, Myrto; Melander, Olle; Jirström, Karin; Peeters, Petra H; Sieri, Sabina; Panico, Salvatore; Cross, Amanda J; Riboli, Elio; Van Guelpen, Bethany; Myte, Robin; Huerta, José María; Rodriguez-Barranco, Miguel; Quirós, José Ramón; Dorronsoro, Miren; Tjønneland, Anne; Olsen, Anja; Travis, Ruth; Boutron-Ruault, Marie-Christine; Carbonnel, Franck; Severi, Gianluca; Bonet, Catalina; Palli, Domenico; Janke, Jürgen; Lee, Young-Ae; Boeing, Heiner; Giovannucci, Edward L; Ogino, Shuji; Fuchs, Charles S; Rimm, Eric; Wu, Kana; Chan, Andrew T; Pischon, Tobias

2017-05-01

Higher levels of circulating adiponectin have been related to lower risk of colorectal cancer in several prospective cohort studies, but it remains unclear whether this association may be causal. We aimed to improve causal inference in a Mendelian Randomization meta-analysis using nested case-control studies of the European Prospective Investigation into Cancer and Nutrition (EPIC, 623 cases, 623 matched controls), the Health Professionals Follow-up Study (HPFS, 231 cases, 230 controls) and the Nurses' Health Study (NHS, 399 cases, 774 controls) with available data on pre-diagnostic adiponectin concentrations and selected single nucleotide polymorphisms in the ADIPOQ gene. We created an ADIPOQ allele score that explained approximately 3% of the interindividual variation in adiponectin concentrations. The ADIPOQ allele score was not associated with risk of colorectal cancer in logistic regression analyses (pooled OR per score-unit unit 0.97, 95% CI 0.91, 1.04). Genetically determined twofold higher adiponectin was not significantly associated with risk of colorectal cancer using the ADIPOQ allele score as instrumental variable (pooled OR 0.73, 95% CI 0.40, 1.34). In a summary instrumental variable analysis (based on previously published data) with higher statistical power, no association between genetically determined twofold higher adiponectin and risk of colorectal cancer was observed (0.99, 95% CI 0.93, 1.06 in women and 0.94, 95% CI 0.88, 1.01 in men). Thus, our study does not support a causal effect of circulating adiponectin on colorectal cancer risk. Due to the limited genetic determination of adiponectin, larger Mendelian Randomization studies are necessary to clarify whether adiponectin is causally related to lower risk of colorectal cancer.

Effects of Exercise on Cognitive Function in Older People with Dementia: A Randomized Controlled Trial.

PubMed

Toots, Annika; Littbrand, Håkan; Boström, Gustaf; Hörnsten, Carl; Holmberg, Henrik; Lundin-Olsson, Lillemor; Lindelöf, Nina; Nordström, Peter; Gustafson, Yngve; Rosendahl, Erik

2017-01-01

Although physical exercise has been suggested to influence cognitive function, previous exercise studies show inconsistent results in people with dementia. To investigate effects of exercise on cognitive function in people with dementia. The Umeå Dementia and Exercise (UMDEX) study, a cluster-randomized controlled trial, was set in 16 nursing homes in Umeå, Sweden. One hundred-and-forty-one women and 45 men with dementia; mean age of 85 y and mean Mini-Mental State Examination (MMSE) score of 15, were randomized to a High-Intensity Functional Exercise program or a seated attention control activity. Blinded assessors measured global cognitive function using the MMSE and the Alzheimer's disease Assessment Scale - Cognitive subscale (ADAS-Cog), and executive function using Verbal fluency (VF) at baseline and 4 months (directly after intervention completion), and MMSE and VF at 7 months. Linear mixed models showed no between-group effects in mean difference from baseline (95% confidence intervals, CI) at 4 months in MMSE (-0.27; 95% CI -1.4 to 0.87, p = 0.644), ADAS-Cog (-1.04, 95% CI -4 to 1.92, p = 0.491), or VF (-0.53, 95% CI -1.42 to 0.35, p = 0.241) or at 7 months in MMSE (-1.15, 95% CI -2.32 to 0.03, p = 0.056) or VF (-0.18, 95% CI -1.09 to 0.74, p = 0.707). A 4-month, high-intensity functional exercise program had no superior effects on global cognition or executive function in people with dementia living in nursing homes when compared with an attention control activity.

A randomized controlled trial of low carbohydrate and low fat/high fiber diets for weight loss.

PubMed Central

Baron, J A; Schori, A; Crow, B; Carter, R; Mann, J I

1986-01-01

Among 135 overweight subjects, we conducted a three-month randomized controlled trial of two sets of dietary advice, each providing approximately 1,000 calories per day but differing in fiber, carbohydrate, and fat content. Information on weight and eating habits, as well as measures of lipoprotein and glucose metabolism were obtained at entry and one and three months later. We found that dieters given low carbohydrate/low fiber dietary advice tended to lose more weight than those given a higher carbohydrate/higher fiber regimen (5.0 vs 3.7 kg on average at three months). This pattern was particularly marked among women, and among participants who were under age 40 or of lower social class. There were no differences between the diet groups in the proportion complaining of hunger but, in general, members of the low carbohydrate group complained of more problems in dieting. There were only minor differences in the serum lipoprotein patterns during the diet period. In view of these results, we believe previous claims of the benefits of fiber for weight loss may have been overstated. PMID:3021006

Learning by (video) example: a randomized study of communication skills training for end-of-life and error disclosure family care conferences.

PubMed

Schmitz, Connie C; Braman, Jonathan P; Turner, Norman; Heller, Stephanie; Radosevich, David M; Yan, Yelena; Miller, Jane; Chipman, Jeffrey G

2016-11-01

Teaching residents to lead end of life (EOL) and error disclosure (ED) conferences is important. We developed and tested an intervention using videotapes of EOL and error disclosure encounters from previous Objective Structured Clinical Exams. Residents (n = 72) from general and orthopedic surgery programs at 2 sites were enrolled. Using a prospective, pre-post, block group design with stratified randomization, we hypothesized the treatment group would outperform the control on EOL and ED cases. We also hypothesized that online course usage would correlate positively with post-test scores. All residents improved (pre-post). At the group level, treatment effects were insignificant, and post-test performance was unrelated to course usage. At the subgroup level for EOL, low performers assigned to treatment scored higher than controls at post-test; and within the treatment group, post graduate year 3 residents outperformed post graduate year ​1 residents. To be effective, online curricula illustrating communication behaviors need face-to-face interaction, individual role play with feedback and discussion. Copyright © 2016 Elsevier Inc. All rights reserved.

Pregnancy Rates Among Juvenile Justice Girls in Two RCTs of Multidimensional Treatment Foster Care

PubMed Central

Kerr, David C. R.; Leve, Leslie D.; Chamberlain, Patricia

2009-01-01

Preventing adolescent pregnancy is a national research priority that has had limited success. The present study examined whether Multidimensional Treatment Foster Care (MTFC) relative to intervention services as usual (group care [GC]) decreased pregnancy rates among juvenile justice girls mandated to out-of-home care. Girls (ages 13–17) with histories of criminal referrals (Mdn = 10) were randomly assigned to MTFC (n = 81) or GC (n = 85) as part of two randomized controlled trials. Pregnancy histories were assessed from baseline through 24 months. Fewer postbaseline pregnancies were reported for MTFC girls (26.9%) than for GC girls (46.9%), an effect that remained significant after controlling for baseline criminal referrals, pregnancy history, and sexual activity. MTFC has previously been shown to decrease arrest and lock-up rates. The present findings support the long-term preventive effects of MTFC on adolescent girls’ pregnancy rates. Findings are consistent with the notion that programs that target delinquency by impacting general risk behavior pathways and contexts may more successfully prevent teen pregnancy than those that directly target sexual behaviors. PMID:19485598

Reviving Cochrane's contribution to evidence-based medicine: bridging the gap between evidence of efficacy and evidence of effectiveness and cost-effectiveness.

PubMed

James, Jack E

2017-09-01

Throughout the quarter century since the advent of evidence-based medicine (EBM), medical research has prioritized 'efficacy' (i.e. internal validity) using randomized controlled trials. EBM has consistently neglected 'effectiveness' and 'cost-effectiveness', identified in the pioneering work of Archie Cochrane as essential for establishing the external (i.e. clinical) validity of health care interventions. Neither Cochrane nor other early pioneers appear to have foreseen the extent to which EBM would be appropriated by the pharmaceutical and medical devices industries, which are responsible for extensive biases in clinical research due to selective reporting, exaggeration of benefits, minimization of risks, and misrepresentation of data. The promise of EBM to effect transformational change in health care will remain unfulfilled until (i) studies of effectiveness and cost-effectiveness are pursued with some of the same fervour that previously succeeded in elevating the status of the randomized controlled trial, and (ii) ways are found to defeat threats to scientific integrity posed by commercial conflicts of interest. © 2017 Stichting European Society for Clinical Investigation Journal Foundation.

Decreasing harsh discipline in mothers at risk for maltreatment: a randomized control trial.

PubMed

Pereira, Mariana; Negrão, Mariana; Soares, Isabel; Mesman, Judi

2014-01-01

This study tested the effectiveness of the attachment-based program Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD; F. Juffer, M.J. Bakermans-Kranenburg, & M.H. van IJzendoorn, 2008) in decreasing harsh discipline of 43 mothers and their 1- to 4-year-old-children from severely deprived families. Based on previous studies, parenting stress was tested as a potential moderator of intervention effects on harsh discipline. Using a randomized control design, maternal harsh discipline was observed during home visits at the pretest and posttest, and mothers filled in questionnaires at both assessments. The VIPP-SD proved to be effective in decreasing maternal harsh discipline, but only for mothers who experienced higher levels of parenting stress at intake. These findings provide support for the program's ability to improve parenting in families who are most at risk for harsh parenting and for potentially maltreating child-parent interactions. The results are discussed in terms of the VIPP-SD elements most relevant to decreasing harsh discipline, and the challenges of parenting interventions in severely deprived populations. © 2014 Michigan Association for Infant Mental Health.

A smartphone application to support recovery from alcoholism: A randomized controlled trial

PubMed Central

Gustafson, David H.; McTavish, Fiona M.; Chih, Ming-Yuan; Atwood, Amy K.; A. Johnson, Roberta; G. Boyle, Michael; S. Levy, Michael; Driscoll, Hilary; M. Chisholm, Steven; Dillenburg, Lisa; Isham, Andrew; Shah, Dhavan

2014-01-01

Importance: Patients leaving treatment for alcohol-use disorders (AUDs) are not typically offered evidence-based continuing care, although research suggests that continuing care is associated with better outcomes. A smartphone-based application could provide effective continuing care. Objective: To determine whether patients leaving residential treatment for AUDs with a smartphone application to support recovery have fewer risky drinking days than control-group patients. Design: An un-blinded randomized controlled trial. Patients were randomized to treatment as usual or treatment as usual plus a smartphone with A-CHESS, an application designed to improve continuing care for AUDs. “A-CHESS” stands for Addiction – Comprehensive Health Enhancement Support System. Setting: Three residential programs operated by one treatment organization in the Midwestern US and 2 residential programs operated by one organization in the Northeastern US. Participants: 349 patients who met the criteria for DSM-IV alcohol dependence when they entered residential treatment. 179 were randomized to the control group and 170 to the treatment group. Intervention: Treatment as usual varied across programs; none offered patients coordinated continuing care after discharge. A-CHESS provides monitoring, information, communication, and support services to patients, including ways for patients and counselors to stay in contact. The intervention lasted 8 months and the follow-up period lasted 4 months. Main Outcome Measure: Risky drinking days—the number of days during which a patient’s drinking in a 2-hour period exceeded, for men, 4 standard drinks and for women, 3 standard drinks. Patients were asked to report their risky drinking days in the previous 30 days on surveys taken 4, 8, and 12 months after discharge from residential treatment. Results: For the 8 months of the intervention and 4 months of follow-up, patients in the A-CHESS group reported significantly fewer risky drinking days than patients in the control group (M = 1.39 vs. 2.75, respectively; P = .003; 95% CI [.46, 2.27]). Conclusions and Relevance: The findings suggest that a multi-featured smartphone application may have significant benefit to patients in continuing care for AUDs. Trial registration: clinicaltrials.gov Identifier: NCT01003119 PMID:24671165

The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial.

PubMed

Freeman, Daniel; Startup, Helen; Myers, Elissa; Harvey, Allison; Geddes, John; Yu, Ly-Mee; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Lister, Rachel

2013-07-11

Patients with psychosis frequently report difficulties getting or staying asleep (insomnia). Dissatisfaction with sleep is high. Insomnia should be treated in this group, but typically it is not even assessed. Importantly, recent evidence indicates that insomnia triggers and exacerbates delusions and hallucinations. The clinical implication is that if the insomnia is treated then the psychotic symptoms will significantly lessen. In a case series with 15 patients with persecutory delusions resistant to previous treatment this is exactly what we found: cognitive behavioural therapy for insomnia (CBT-I) led to large reductions in both the insomnia and delusions. The clear next step is a pilot randomized controlled test. The clinical aim is to test whether CBT-I can reduce both insomnia and psychotic symptoms. The trial will inform decisions for a definitive large-scale evaluation. We will carry out a randomized controlled trial (the Better Sleep Trial, or the BEST study) with 60 patients with distressing delusions or hallucinations in the context of a schizophrenia spectrum diagnosis. Half of the participants will be randomized to receive CBT-I, in addition to their standard treatment, for up to eight sessions over 12 weeks. The other half will continue with treatment as usual. Blind assessments will take place at 0 weeks, 12 weeks (post-treatment) and 24 weeks (follow-up). The primary outcome hypotheses are that CBT-I added to treatment as usual will improve sleep, delusions and hallucinations compared with only treatment as usual. All main analyses will be carried out at the end of the last follow-up assessments and will be based on the intention-to-treat principle. The trial is funded by the NHS National Institute for Health Research (NIHR) Research for Patient Benefit Programme. Data collection will be complete by the end of 2014. This will be the first controlled test of CBT-I for patients with delusions and hallucinations. It will provide significant evidence for an easily administered intervention that is likely to prove very popular with patients experiencing the difficult-to-treat problems of delusions and hallucinations. Current Controlled Trials ISRCTN 33695128.

The effect of India's total sanitation campaign on defecation behaviors and child health in rural Madhya Pradesh: a cluster randomized controlled trial.

PubMed

Patil, Sumeet R; Arnold, Benjamin F; Salvatore, Alicia L; Briceno, Bertha; Ganguly, Sandipan; Colford, John M; Gertler, Paul J

2014-08-01

Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009), and revisited households 21 months later (February-April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. ClinicalTrials.gov NCT01465204. Please see later in the article for the Editors' Summary.

The Effect of India's Total Sanitation Campaign on Defecation Behaviors and Child Health in Rural Madhya Pradesh: A Cluster Randomized Controlled Trial

PubMed Central

Patil, Sumeet R.; Arnold, Benjamin F.; Salvatore, Alicia L.; Briceno, Bertha; Ganguly, Sandipan; Colford, John M.; Gertler, Paul J.

2014-01-01

Background Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). Methods and Findings We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May–July 2009), and revisited households 21 months later (February–April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%–26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%–15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. Conclusions The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. Trial Registration ClinicalTrials.gov NCT01465204 Please see later in the article for the Editors' Summary PMID:25157929

Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder.

PubMed

Banaschewski, Tobias; Johnson, Mats; Lecendreux, Michel; Zuddas, Alessandro; Adeyi, Ben; Hodgkins, Paul; Squires, Liza A; Coghill, David R

2014-12-01

The stimulant prodrug lisdexamfetamine dimesylate (LDX) is an effective and generally well tolerated treatment for the symptoms of attention-deficit/hyperactivity disorder (ADHD). Positive impacts of LDX on health-related quality of life and functional impairment have previously been demonstrated in a 7-week, randomized, double-blind, placebo-controlled, phase III study in children and adolescents in Europe. Maintenance of these broad benefits, as well as symptomatic control, is a key goal of long-term management of ADHD. Secondary objectives of this multinational study in children and adolescents with ADHD were to assess the long-term maintenance of effectiveness of LDX in improving health-related quality of life and reducing functional impairment, as gauged using the Child Health and Illness Profile-Child Edition: Parent Report Form (CHIP-CE: PRF) and the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P), respectively. Patients aged 6-17 years with diagnosed ADHD and a baseline ADHD Rating Scale IV total score of at least 28 were enrolled from the previous European study and from US sites. Patients who completed an open-label LDX treatment period of at least 26 weeks were randomized (1:1) to continue on their optimized dose of LDX or to switch to placebo for a 6-week, double-blind, withdrawal period. Parents completed CHIP-CE: PRF and WFIRS-P questionnaires at weeks 0, 8 and 26 of the open-label period and at weeks 0 and 6 of the randomized-withdrawal period, or at early termination. The endpoint of each period was defined as the last visit with valid data. Effect sizes were the difference (LDX minus placebo) in least-squares (LS)-mean change from baseline to endpoint divided by root-mean-square error. P values were nominal and not adjusted for multiple comparisons. The open-label and randomized full analysis sets comprised 262 and 153 (LDX n = 76; placebo n = 77) patients, respectively. Mean pretreatment CHIP-CE: PRF T-scores were more than one standard deviation below the normative mean in four of the five domains, and there was significant improvement across all domains from baseline to endpoint of the open-label period. In the randomized-withdrawal period, LS-mean CHIP-CE: PRF T-scores deteriorated in all domains in the placebo group, but not in the LDX group. Compared with placebo, the effect of LDX was significant in the Risk Avoidance (effect size 0.829; p < 0.001), Achievement (0.696; p < 0.001) and Satisfaction (0.636; p < 0.001) domains. Mean pretreatment WFIRS-P scores were lowest in the Family domain and the Learning and School domain. WFIRS-P total score and scores in all domains improved significantly from baseline to endpoint of the open-label period. In the randomized-withdrawal period, LS-mean scores deteriorated in the placebo group but not in the LDX group. Compared with placebo, the effect of LDX was significant in the Family, Learning and School, and Risky Activities domains and in total (effect size 0.908; p < 0.001). Using parent-rated instruments, long-term maintenance of the beneficial effect of LDX in multiple domains of health-related quality of life and functional impairment was demonstrated by comparison of treatment continuation and withdrawal under randomized, double-blind, placebo-controlled conditions.

The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial

PubMed Central

Wild, Beate; Friederich, Hans-Christoph; Gross, Gaby; Teufel, Martin; Herzog, Wolfgang; Giel, Katrin E; de Zwaan, Martina; Schauenburg, Henning; Schade-Brittinger, Carmen; Schäfer, Helmut; Zipfel, Stephan

2009-01-01

Background Anorexia nervosa is a serious eating disorder leading to high morbidity and mortality as a result of both malnutrition and suicide. The seriousness of the disorder requires extensive knowledge of effective treatment options. However, evidence for treatment efficacy in this area is remarkably weak. A recent Cochrane review states that there is an urgent need for large, well-designed treatment studies for patients with anorexia nervosa. The aim of this particular multi-centre study is to evaluate the efficacy of two standardized outpatient treatments for patients with anorexia nervosa: focal psychodynamic (FPT) and cognitive behavioural therapy (CBT). Each therapeutic approach is compared to a "treatment-as-usual" control group. Methods/Design 237 patients meeting eligibility criteria are randomly and evenly assigned to the three groups – two intervention groups (CBT and FPT) and one control group. The treatment period for each intervention group is 10 months, consisting of 40 sessions respectively. Body weight, eating disorder related symptoms, and variables of therapeutic alliance are measured during the course of treatment. Psychotherapy sessions are audiotaped for adherence monitoring. The treatment in the control group, both the dosage and type of therapy, is not regulated in the study protocol, but rather reflects the current practice of established outpatient care. The primary outcome measure is the body mass index (BMI) at the end of the treatment (10 months after randomization). Discussion The study design surmounts the disadvantages of previous studies in that it provides a randomized controlled design, a large sample size, adequate inclusion criteria, an adequate treatment protocol, and a clear separation of the treatment conditions in order to avoid contamination. Nevertheless, the study has to deal with difficulties specific to the psychopathology of anorexia nervosa. The treatment protocol allows for dealing with the typically occurring medical complications without dropping patients from the protocol. However, because patients are difficult to recruit and often ambivalent about treatment, a drop-out rate of 30% is assumed for sample size calculation. Due to the ethical problem of denying active treatment to patients with anorexia nervosa, the control group is defined as "treatment-as-usual". Trial registration Current Controlled Trials ISRCTN72809357 PMID:19389245

Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the MINERVA randomized multicentre international trial.

PubMed

Boriani, Giuseppe; Tukkie, Raymond; Manolis, Antonis S; Mont, Lluis; Pürerfellner, Helmut; Santini, Massimo; Inama, Giuseppe; Serra, Paolo; de Sousa, João; Botto, Giovanni Luca; Mangoni, Lorenza; Grammatico, Andrea; Padeletti, Luigi

2014-09-14

Atrial fibrillation (AF) is a common comorbidity in bradycardia patients. Advanced pacemakers feature atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), which minimizes unnecessary right ventricular pacing. We evaluated whether DDDRP and MVP might reduce mortality, morbidity, or progression to permanent AF when compared with standard dual-chamber pacing (Control DDDR). In a randomized, parallel, single-blind, multi-centre trial we enrolled 1300 patients with bradycardia and previous atrial tachyarrhythmias, in whom a DDDRP pacemaker had recently been implanted. History of permanent AF and third-degree atrioventricular block were exclusion criteria. After a 1-month run-in period, 1166 eligible patients, aged 74 ± 9 years, 50% females, were randomized to Control DDDR, DDDRP + MVP, or MVP. Analysis was intention-to-treat. The primary outcome, i.e. the 2-year incidence of a combined endpoint composed of death, cardiovascular hospitalizations, or permanent AF, occurred in 102/385 (26.5%) Control DDDR patients, in 76/383 (19.8%) DDDRP + MVP patients [hazard ratio (HR) = 0.74, 95% confidence interval 0.55-0.99, P = 0.04 vs. Control DDDR] and in 85/398 (21.4%) MVP patients (HR = 0.89, 95% confidence interval 0.77-1.03, P = 0.125 vs. Control DDDR). When compared with Control DDDR, DDDRP + MVP reduced the risk for AF longer than 1 day (HR = 0.66, 95% CI 0.52-0.85, P < 0.001), AF longer than 7 days (HR = 0.52, 95% CI 0.36-0.73, P < 0.001), and permanent AF (HR = 0.39, 95% CI 0.21-0.75, P = 0.004). In patients with bradycardia and atrial tachyarrhythmias, DDDRP + MVP is superior to standard dual-chamber pacing. The primary endpoint was significantly lowered through the reduction of the progression of atrial tachyarrhythmias to permanent AF. NCT00262119. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.

Influence of Inter-Training Intervals on Intermanual Transfer Effects in Upper-Limb Prosthesis Training: A Randomized Pre-Posttest Study.

PubMed

Romkema, Sietske; Bongers, Raoul M; van der Sluis, Corry K

2015-01-01

Improvement in prosthetic training using intermanual transfer (the transfer of motor skills from the trained, “unaffected” hand to the untrained, “affected” hand) has been shown in previous studies. The aim of this study is to determine the influence of the inter-training interval on the magnitude of the intermanual transfer effects. This was done using a mechanistic, randomized, single-blinded pretest-posttest design. Sixty-four able-bodied, right-handed participants were randomly assigned to the Short and Long Interval Training Groups and the Short and Long Interval Control Groups. The Short and Long Interval Training Groups used a prosthesis simulator in their training program. The Short and Long Interval Control Groups executed a sham training program, that is, a dummy training program in which the same muscles were trained as with the prosthesis simulator. The Short Interval Training Group and the Short Interval Control Groups trained on consecutive days, while the Long Interval Training Group and Long Interval Control Group trained twice a week. To determine the improvement in skills, a test was administered before, immediately after, and at two points in time after the training. Training was performed with the “unaffected” arm; tests were performed with the “affected” arm. The outcome measurements were: the movement time (the time from the beginning of the movement until completion of the task); the duration of maximum hand opening, (the opening of the prosthetic hand while grasping an object); and the grip-force control (the error from the required grip-force during a tracking task). Intermanual transfer was found in movement times, but not in hand opening or grip-force control. The length of the inter-training interval did not affect the magnitude of intermanual transfer effects. No difference in the intermanual transfer effect in upper-limb prosthesis training was found for training on a daily basis as compared to training twice a week. Nederlands Trial Register NTR3888.

Influence of Inter-Training Intervals on Intermanual Transfer Effects in Upper-Limb Prosthesis Training: A Randomized Pre-Posttest Study

PubMed Central

Romkema, Sietske; Bongers, Raoul M.; van der Sluis, Corry K.

2015-01-01

Improvement in prosthetic training using intermanual transfer (the transfer of motor skills from the trained, “unaffected” hand to the untrained, “affected” hand) has been shown in previous studies. The aim of this study is to determine the influence of the inter-training interval on the magnitude of the intermanual transfer effects. This was done using a mechanistic, randomized, single-blinded pretest-posttest design. Sixty-four able-bodied, right-handed participants were randomly assigned to the Short and Long Interval Training Groups and the Short and Long Interval Control Groups. The Short and Long Interval Training Groups used a prosthesis simulator in their training program. The Short and Long Interval Control Groups executed a sham training program, that is, a dummy training program in which the same muscles were trained as with the prosthesis simulator. The Short Interval Training Group and the Short Interval Control Groups trained on consecutive days, while the Long Interval Training Group and Long Interval Control Group trained twice a week. To determine the improvement in skills, a test was administered before, immediately after, and at two points in time after the training. Training was performed with the “unaffected” arm; tests were performed with the “affected” arm. The outcome measurements were: the movement time (the time from the beginning of the movement until completion of the task); the duration of maximum hand opening, (the opening of the prosthetic hand while grasping an object); and the grip-force control (the error from the required grip-force during a tracking task). Intermanual transfer was found in movement times, but not in hand opening or grip-force control. The length of the inter-training interval did not affect the magnitude of intermanual transfer effects. No difference in the intermanual transfer effect in upper-limb prosthesis training was found for training on a daily basis as compared to training twice a week. Trial Registration Nederlands Trial Register NTR3888 PMID:26075396

No Effect of Insecticide Treated Curtain Deployment on Aedes Infestation in a Cluster Randomized Trial in a Setting of Low Dengue Transmission in Guantanamo, Cuba

PubMed Central

Lambert, Isora; Montada, Domingo; Baly, Alberto; Van der Stuyft, Patrick

2015-01-01

Objective & Methodology The current study evaluated the effectiveness and cost-effectiveness of Insecticide Treated Curtain (ITC) deployment for reducing dengue vector infestation levels in the Cuban context with intensive routine control activities. A cluster randomized controlled trial took place in Guantanamo city, east Cuba. Twelve neighborhoods (about 500 households each) were selected among the ones with the highest Aedes infestation levels in the previous two years, and were randomly allocated to the intervention and control arms. Long lasting ITC (PermaNet) were distributed in the intervention clusters in March 2009. Routine control activities were continued in the whole study area. In both study arms, we monitored monthly pre- and post-intervention House Index (HI, number of houses with at least 1 container with Aedes immature stages/100 houses inspected), during 12 and 18 months respectively. We evaluated the effect of ITC deployment on HI by fitting a generalized linear regression model with a negative binomial link function to these data. Principal Findings At distribution, the ITC coverage (% of households using ≥1 ITC) reached 98.4%, with a median of 3 ITC distributed/household. After 18 months, the coverage remained 97.4%. The local Aedes species was susceptible to deltamethrin (mosquito mortality rate of 99.7%) and the residual deltamethrin activity in the ITC was within acceptable levels (mosquito mortality rate of 73.1%) after one year of curtain use. Over the 18 month observation period after ITC distribution, the adjusted HI rate ratio, intervention versus control clusters, was 1.15 (95% CI 0.57 to 2.34). The annualized cost per household of ITC implementation was 3.8 USD, against 16.8 USD for all routine ACP activities. Conclusion Deployment of ITC in a setting with already intensive routine Aedes control actions does not lead to reductions in Aedes infestation levels. PMID:25794192

Long-term effects of a 12 weeks high-intensity functional exercise program on physical function and mental health in nursing home residents with dementia: a single blinded randomized controlled trial.

PubMed

Telenius, Elisabeth Wiken; Engedal, Knut; Bergland, Astrid

2015-12-03

Research indicates that exercise can have a positive effect on both physical and mental health in nursing home patients with dementia, however the lasting effect is rarely studied. In a previously published article we investigated the immediate effect of a 12 weeks functional exercise program on physical function and mental health in nursing home residents with dementia. In this paper we studied the long-term effect of this exercise program. We explored the differences between the exercise and control group from baseline to 6 months follow-up and during the detraining period from month 3 to 6. A single blind, randomized controlled trial was conducted and a total of 170 nursing home residents with dementia were included. The participants were randomly allocated to an intervention (n = 87) or a control group (n = 83). The intervention consisted of intensive strengthening and balance exercises in small groups twice a week for 12 weeks. The control condition was leisure activities. Thirty participants were lost between baseline and six-month follow-up. Linear mixed model analyses for repeated measurements were used to investigate the effect of exercise after detraining period. The exercise group improved their scores on Berg Balance Scale from baseline to 6 months follow-up by 2.7 points in average. The control group deteriorated in the same period and the difference between groups was statistically significant (p = 0.031). The exercise group also scored better on NPI agitation sub-score after 6 months (p = 0.045). The results demonstrate long-time positive effects of a high intensity functional exercise program on balance and indicate a positive effect on agitation, after an intervention period of 12 weeks followed by a detraining period of 12 weeks. Identifier at ClinicalTrials.gov: NCT02262104.

Mental practice enhances surgical technical skills: a randomized controlled study.

PubMed

Arora, Sonal; Aggarwal, Rajesh; Sirimanna, Pramudith; Moran, Aidan; Grantcharov, Teodor; Kneebone, Roger; Sevdalis, Nick; Darzi, Ara

2011-02-01

To assess the effects of mental practice on surgical performance. Increasing concerns for patient safety have highlighted a need for alternative training strategies outside the operating room. Mental practice (MP), "the cognitive rehearsal of a task before performance," has been successful in sport and music to enhance skill. This study investigates whether MP enhances performance in laparoscopic surgery. After baseline skills testing, 20 novice surgeons underwent training on an evidence-based virtual reality curriculum. After randomization using the closed envelope technique, all participants performed 5 Virtual Reality (VR) laparoscopic cholecystectomies (LC). Mental practice participants performed 30 minutes of MP before each LC; control participants viewed an online lecture. Technical performance was assessed using video Objective Structured Assessment of Technical Skills-based global ratings scale (scored from 7 to 35). Mental imagery was assessed using a previously validated Mental Imagery Questionnaire. Eighteen participants completed the study. There were no intergroup differences in baseline technical ability. Learning curves were demonstrated for both MP and control groups. Mental practice was superior to control (global ratings) for the first LC (median 20 vs 15, P = 0.005), second LC (20.5 vs 13.5, P = 0.001), third LC (24 vs 15.5, P < 0.001), fourth LC (25.5 vs 15.5, P < 0.001) and the fifth LC (27.5 vs 19.5, P = 0.00). The imagery for the MP group was also significantly superior to the control group across all sessions (P < 0.05). Improved imagery significantly correlated with better quality of performance (ρ 0.51–0.62, Ps < 0.05). This is the first randomized controlled study to show that MP enhances the quality of performance based on VR laparoscopic cholecystectomy. This may be a time- and cost-effective strategy to augment traditional training in the OR thus potentially improving patient care.

Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study.

PubMed

Klein-Laansma, Christien T; Jong, Mats; von Hagens, Cornelia; Jansen, Jean Pierre C H; van Wietmarschen, Herman; Jong, Miek C

2018-03-22

Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) bother a substantial number of women. Homeopathy seems a promising treatment, but it needs investigation using reliable study designs. The feasibility of organizing an international randomized pragmatic trial on a homeopathic add-on treatment (usual care [UC] + HT) compared with UC alone was evaluated. A multicenter, randomized, controlled pragmatic trial with parallel groups. The study was organized in general and private homeopathic practices in the Netherlands and Sweden and in an outpatient university clinic in Germany. Women diagnosed as having PMS/PMDD, based on prospective daily rating by the daily record of severity of problems (DRSP) during a period of 2 months, were included and randomized. Women were to receive UC + HT or UC for 4 months. Homeopathic medicine selection was according to a previously tested prognostic questionnaire and electronic algorithm. Usual care was as provided by the women's general practitioner according to their preferences. Before and after treatment, the women completed diaries (DRSP), the measure yourself concerns and well-being, and other questionnaires. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. In Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03). With respect to recruitment and different legal status, it does not seem feasible to perform a larger, international, pragmatic randomized trial on (semi-)individualized homeopathy for PMS/PMDD. Since the added value of HT compared with UC was demonstrated by significant differences in symptom score changes, further studies are warranted.

Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial

PubMed Central

Little, Paul; Stuart, Beth; Wingrove, Zoe; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Richards-Hall, Samantha; Williamson, Ian; Yao, Lily; Zhu, Shihua; Moore, Michael

2017-01-01

BACKGROUND: Reducing the use of antibiotics for upper respiratory tract infections is needed to limit the global threat of antibiotic resistance. We estimated the effectiveness of probiotics and xylitol for the management of pharyngitis. METHODS: In this parallel-group factorial randomized controlled trial, participants in primary care (aged 3 years or older) with pharyngitis underwent randomization by nurses who provided sequential intervention packs. Pack contents for 3 kinds of material and advice were previously determined by computer-generated random numbers: no chewing gum, xylitol-based chewing gum (15% xylitol; 5 pieces daily) and sorbitol gum (5 pieces daily). Half of each group were also randomly assigned to receive either probiotic capsules (containing 24 × 109 colony-forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was mean self-reported severity of sore throat and difficulty swallowing (scale 0–6) in the first 3 days. We used multiple imputation to avoid the assumption that data were missing completely at random. RESULTS: A total of 1009 individuals consented, 934 completed the baseline assessment, and 689 provided complete data for the primary outcome. Probiotics were not effective in reducing the severity of symptoms: mean severity scores 2.75 with no probiotic and 2.78 with probiotic (adjusted difference −0.001, 95% confidence interval [CI] −0.24 to 0.24). Chewing gum was also ineffective: mean severity scores 2.73 without gum, 2.72 with sorbitol gum (adjusted difference 0.07, 95% CI −0.23 to 0.37) and 2.73 with xylitol gum (adjusted difference 0.01, 95% CI −0.29 to 0.30). None of the secondary outcomes differed significantly between groups, and no harms were reported. INTERPRETATION: Neither probiotics nor advice to chew xylitol-based chewing gum was effective for managing pharyngitis. Trial registration: ISRCTN, no. ISRCTN51472596 PMID:29255098

Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial.

PubMed

Little, Paul; Stuart, Beth; Wingrove, Zoe; Mullee, Mark; Thomas, Tammy; Johnson, Sophie; Leydon, Gerry; Richards-Hall, Samantha; Williamson, Ian; Yao, Lily; Zhu, Shihua; Moore, Michael

2017-12-18

Reducing the use of antibiotics for upper respiratory tract infections is needed to limit the global threat of antibiotic resistance. We estimated the effectiveness of probiotics and xylitol for the management of pharyngitis. In this parallel-group factorial randomized controlled trial, participants in primary care (aged 3 years or older) with pharyngitis underwent randomization by nurses who provided sequential intervention packs. Pack contents for 3 kinds of material and advice were previously determined by computer-generated random numbers: no chewing gum, xylitol-based chewing gum (15% xylitol; 5 pieces daily) and sorbitol gum (5 pieces daily). Half of each group were also randomly assigned to receive either probiotic capsules (containing 24 × 10 9 colony-forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was mean self-reported severity of sore throat and difficulty swallowing (scale 0-6) in the first 3 days. We used multiple imputation to avoid the assumption that data were missing completely at random. A total of 1009 individuals consented, 934 completed the baseline assessment, and 689 provided complete data for the primary outcome. Probiotics were not effective in reducing the severity of symptoms: mean severity scores 2.75 with no probiotic and 2.78 with probiotic (adjusted difference -0.001, 95% confidence interval [CI] -0.24 to 0.24). Chewing gum was also ineffective: mean severity scores 2.73 without gum, 2.72 with sorbitol gum (adjusted difference 0.07, 95% CI -0.23 to 0.37) and 2.73 with xylitol gum (adjusted difference 0.01, 95% CI -0.29 to 0.30). None of the secondary outcomes differed significantly between groups, and no harms were reported. Neither probiotics nor advice to chew xylitol-based chewing gum was effective for managing pharyngitis. Trial registration: ISRCTN, no. ISRCTN51472596. © 2017 Joule Inc. or its licensors.

Seminar on Understanding Digital Control and Analysis in Vibration Test Systems, part 2

NASA Technical Reports Server (NTRS)

1975-01-01

A number of techniques for dealing with important technical aspects of the random vibration control problem are described. These include the generation of pseudo-random and true random noise, the control spectrum estimation problem, the accuracy/speed tradeoff, and control correction strategies. System hardware, the operator-system interface, safety features, and operational capabilities of sophisticated digital random vibration control systems are also discussed.

SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Sedentary lifestyles are now becoming a major concern for governments of developed and developing countries with physical inactivity related to increased all-cause mortality, lower quality of life, and increased risk of obesity, diabetes, hypertension and many other chronic diseases. The powerful onboard computing capacity of smartphones, along with the unique relationship individuals have with their mobile phones, suggests that mobile devices have the potential to influence behavior. However, no previous trials have been conducted using smartphone technology to promote physical activity. This project has the potential to provide robust evidence in this area of innovation. The aim of this study is to evaluate the effectiveness of a smartphone application as an intervention to promote physical activity in primary care. Methods/design A two-group, parallel randomized controlled trial (RCT) with a main outcome measure of mean difference in daily step count between baseline and follow up over eight weeks. A minimum of 80 active android smartphone users over 16 years of age who are able to undertake moderate physical activity are randomly assigned to the intervention group (n = 40) or to a control group (n = 40) for an eight week period. After randomization, all participants will complete a baseline period of one week during which a baseline mean daily step count will be established. The intervention group will be instructed in the usability features of the smartphone application, will be encouraged to try to achieve 10,000 steps per day as an exercise goal and will be given an exercise promotion leaflet. The control group will be encouraged to try to walk an additional 30 minutes per day along with their normal activity (the equivalent of 10,000 steps) as an exercise goal and will be given an exercise promotion leaflet. The primary outcome is mean difference in daily step count between baseline and follow-up. Secondary outcomes are systolic and diastolic blood pressure, resting heart rate, mental health score using HADS and quality of life score using Euroqol. Randomization and allocation to the intervention and groups will be carried out by an independent researcher, ensuring the allocation sequence is concealed from the study researchers until the interventions are assigned. The primary analysis is based on mean daily step count, comparing the mean difference in daily step count between the baseline and the trial periods in the intervention and control groups at follow up. Trial registration Current Controlled Trials ISRCTN99944116 PMID:23714362

Randomized, Double-Blinded, Placebo-Controlled Crossover Trial of Treating Erectile Dysfunction with Sildenafil After Radiotherapy and Short-Term Androgen Deprivation Therapy: Results of RTOG 0215

PubMed Central

Bruner, Deborah Watkins; James, Jennifer L.; Bryan, Charlene J.; Pisansky, Thomas M.; Rotman, Marvin; Corbett, Thomas; Speight, Joycelyn; Byhardt, Roger; Sandler, Howard; Bentzen, Søren; Kachnic, Lisa; Berk, Lawrence

2013-01-01

Introduction Erectile dysfunction (ED) may be the most commonly observed adverse event (AE) associated with the combination of radiation therapy (RT) and androgen deprivation therapy (ADT). A significant number of men are trying phosphodiesterase type 5 inhibitors (PDE5s) such as sildenafil to treat ED, yet sildenafil studies to date shed little light on the response to ED after ADT. Aim The purpose of this trial was to evaluate sildenafil in the treatment of ED in prostate cancer patients previously treated with external beam RT and neoadjuvant and concurrent ADT. Methods In this randomized, double-blinded crossover trial, eligible patients received RT/ADT for intermediate risk prostate cancer and currently had ED as defined by the International Index of Erectile Function (IIEF). Patients were randomized to 12 weeks of sildenafil or placebo followed by 1 week of no treatment then 12 weeks of the alternative. Treatment differences were evaluated using a marginal model for binary crossover data. Main Outcome Measures The primary end point was improved erectile function, as measured by the IIEF. Results The study accrued 115 patients and 61 (55%) completed all three IIEF assessments. Sildenafil effect was significant (P = 0.009) with a difference in probabilities of erectile response of 0.17 (95% confidence interval: 0.06, 0.29), and 0.21 (0.06, 0.38) for patients receiving ≤120 days of ADT. However, as few as 21% of patients had a treatment-specific response, only improving during sildenafil but not during the placebo phase. Conclusions This is the first controlled trial to suggest a positive sildenafil response for ED treatment in patients previously treated with RT/ADT, however, only a minority of patients responded to treatment. ADT duration may be associated with response and requires further study. The overall low response rate suggests the need for study of additional or preventative strategies for ED after RT/ADT for prostate cancer. PMID:21235716

Phase III randomized trial comparing LDR and HDR brachytherapy in treatment of cervical carcinoma.

PubMed

Lertsanguansinchai, Prasert; Lertbutsayanukul, Chawalit; Shotelersuk, Kanjana; Khorprasert, Chonlakiet; Rojpornpradit, Prayuth; Chottetanaprasith, Taywin; Srisuthep, Apiradee; Suriyapee, Sivalee; Jumpangern, Chotika; Tresukosol, Damrong; Charoonsantikul, Chulee

2004-08-01

Intracavitary brachytherapy plays an important role in the treatment of cervical carcinoma. Previous results have shown controversy between the effect of dose rate on tumor control and the occurrence of complications. We performed a prospective randomized clinical trial to compare the clinical outcomes between low-dose-rate (LDR) and high-dose-rate (HDR) intracavitary brachytherapy for treatment of invasive uterine cervical carcinoma. A total of 237 patients with previously untreated invasive carcinoma of the uterine cervix treated at King Chulalongkorn Memorial Hospital were randomized between June 1995 and December 2001. Excluding ineligible, incomplete treatment, and incomplete data patients, 109 and 112 patients were in the LDR and HDR groups, respectively. All patients were treated with external beam radiotherapy and LDR or HDR intracavitary brachytherapy using the Chulalongkorn treatment schedule. The median follow-up for the LDR and HDR groups was 40.2 and 37.2 months, respectively. The actuarial 3-year overall and relapse-free survival rate for all patients was 69.6% and 70%, respectively. The 3-year overall survival rate in the LDR and HDR groups was 70.9% and 68.4% (p = 0.75) and the 3-year pelvic control rate was 89.1% and 86.4% (p = 0.51), respectively. The 3-year relapse-free survival rate in both groups was 69.9% (p = 0.35). Most recurrences were distant metastases, especially in Stage IIB and IIIB patients. Grade 3 and 4 complications were found in 2.8% and 7.1% of the LDR and HDR groups (p = 0.23). Comparable outcomes were demonstrated between LDR and HDR intracavitary brachytherapy. Concerning patient convenience, the lower number of medical personnel needed, and decreased radiation to health care workers, HDR intracavitary brachytherapy is an alternative to conventional LDR brachytherapy. The high number of distant failure suggests that other modalities such as systemic concurrent or adjuvant chemotherapy might lower this high recurrence, especially in Stage IIB and IIIB.

Raloxifene as an Adjunctive Treatment for Postmenopausal Women With Schizophrenia: A 24-Week Double-Blind, Randomized, Parallel, Placebo-Controlled Trial.

PubMed

Usall, Judith; Huerta-Ramos, Elena; Labad, Javier; Cobo, Jesús; Núñez, Christian; Creus, Marta; Parés, Gemma García; Cuadras, Daniel; Franco, José; Miquel, Eva; Reyes, Julio César; Roca, Mercedes

2016-03-01

The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator, appears to act similarly to estrogens on dopamine and serotonin brain systems. One previous trial by our team found that raloxifene was useful to improve negative, positive, and general psychopathological symptoms, without having the negative side effects of estrogens. In this study, we assess the utility of raloxifene in treating negative and other psychotic symptoms in postmenopausal women with schizophrenia exhibiting prominent negative symptoms. This was a 24-week, randomized, parallel, double-blind, placebo-controlled study. Patients were recruited from the inpatient and outpatient departments of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy postmenopausal women with schizophrenia (DSM-IV) were randomized to either adjunctive raloxifene (38 women) or adjunctive placebo (32 women). Psychopathological symptoms were assessed at baseline and at weeks 4, 12, and 24 with the Positive and Negative Syndrome Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS). The addition of raloxifene (60 mg/d) to regular antipsychotic treatment significantly reduced negative (P = .027), general (P = .003), and total symptomatology (P = .005) measured with the PANSS during the 24-week trial, as compared to women receiving placebo. Also Alogia SANSS subscale improved more in the raloxifene (P = .048) than the placebo group. In conclusion, raloxifene improved negative and general psychopathological symptoms, compared with antipsychotic medication alone, in postmenopausal women with schizophrenia. These data replicate our previous results with a larger sample and a longer follow-up. NCT01573637. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Survey of asthma management in Thailand - the asthma insight and management study.

PubMed

Boonsawat, Watchara; Thompson, Philip J; Zaeoui, Uraiwan; Samosorn, Chanee; Acar, Gurbet; Faruqi, Rab; Poonnoi, Piriya

2015-03-01

Previous Thai surveys of asthma care have shown suboptimal management and poor control. Since then several editions of the Thailand National Asthma Guidelines have been distributed to help improve asthma control. A new survey was undertaken to see if any improvement in care had occurred. It examined patients' insights, attitudes and perceptions about their asthma and its treatment. Asthma patients (>12 years) were randomly selected and participated in face-to-face interviews. Patients answered 53 questions exploring general health, diagnosis, symptoms, exacerbations, patient burden, disease management, treatment and attitudes. The Global Initiative for Asthma guidelines were used to assess asthma control. Data were obtained from 400 asthma patients from 8,177 screened households. This showed that 36% had had exacerbations in the previous year, 17% had been hospitalized and 35% had had an unscheduled emergency visit to hospital or a doctor's office or clinic. Work or school was missed by 44% due to asthma while a similar number had had an asthma episode that made them feel their life was in danger. Only 8% had good asthma control. Patients had low expectations with respect to asthma treatment and their understanding of how to use therapies was poor. Forty-four percent of participants reported day-time symptoms and about one-third (34%) of adults and adolescents in the survey reported night-time symptoms at least once a week in the previous 4 weeks. Asthma patients in Thailand rated their average productivity when asthma was at its worst at 48%, on a scale of 0 to 100%, which equates to a 36% decline in productivity. Rescue medication during the previous four weeks had been used by 44% of asthma patients while 54% had used a controller medication. Pill controller medication is the most used form among those reporting controller medication use (67%), whereas 57% reported taking an inhaler. Oral steroids had been used in the previous 12 months by 40% of patients with the average number for 3 day or longer at 24 times, while the median was about 4 times. Asthma had a profound impact on patients' wellbeing, despite the availability of effective treatments and evidence-based management guidelines. A large proportion of asthma patients overestimate their asthma control and have inappropriate concepts about asthma treatment. Gaining better insight into patient's attitudes about self-care is critical to improve asthma management.

Hormone therapy and physical function change among older women in the Women’s Health Initiative: a randomized controlled trial

PubMed Central

Michael, Yvonne L.; Gold, Rachel; Manson, JoAnn E.; Keast, Erin M.; Cochrane, Barbara B.; Woods, Nancy F.; Brzyski, Robert G.; McNeeley, S. Gene; Wallace, Robert B.

2011-01-01

Objective Although estrogen may be linked to biological pathways that maintain higher physical function, the evidence is derived mostly from observational epidemiology and therefore has numerous limitations. We examined whether hormone therapy affected physical function in women 65 to 79 years of age at enrollment. Methods This study involves an analysis of the Women’s Health Initiative randomized controlled trials of hormone therapy in which 922 nondisabled women who had previous hysterectomies were randomized to receive estrogen therapy or a placebo and 1,458 nondisabled women with intact uteri were randomized to receive estrogen + progestin therapy or a placebo. Changes in physical function were analyzed for treatment effect, and subgroup differences were evaluated. All women completed performance-based measures of physical function (grip strength, chair stands, and timed walk) at baseline. These measures were repeated after 1, 3, and 6 years. Results Overall, participants’ grip strength declined by 12.0%, chair stands declined by 3.5%, and walk pace slowed by 11.4% in the 6 years of follow-up (all P values <0.0001). Hormone therapy, as compared with placebo, was not associated with an increased or decreased risk of decline in physical function in either the intention-to-treat analyses or in analyses restricted to participants who were compliant in taking study pills. Conclusions Hormone therapy provided no overall protection against functional decline in nondisabled postmenopausal women 65 years or older in 6 years of follow-up. This study did not address the influence of hormone therapy for women of younger ages. PMID:19858764

Urinary retention: benefit of gradual bladder decompression - myth or truth? A randomized controlled trial.

PubMed

Boettcher, S; Brandt, A S; Roth, S; Mathers, M J; Lazica, D A

2013-01-01

Urinary retention is a common emergency requiring immediate catheterization. Gradual decompression (GD) of the extended bladder is believed to minimize the risk of complications such as bleeding or circulatory collapse, but to date it has not been compared with rapid decompression (RD) in controlled trials. Male patients presenting with urinary retention (n = 294) were randomized to rapid or gradual catheterization. For the latter, the transurethral catheter was clamped for 5 min after every 200-ml outflow until the bladder was completely empty. Patients were monitored for at least 30 min thereafter with regular checks of vital signs and presence of macroscopic hematuria. Of 294 patients, 142 (48.3%) were randomized to the GD and 152 (51.7%) to the RD group. Both groups showed no statistically significant difference with regard to age, anticoagulation treatment, catheter size and material, or volume retained. Hematuria occurred in 16 (11.3%) of the GD and 16 (10.5%) of the RD group; 6 patients in the former and 4 in the latter required further treatment. No circulatory collapse occurred. We noted a decrease in the previously raised blood pressure and heart rate in both groups, although without clinical significance. In this first randomized trial, no statistically significant difference was noted between gradual and rapid emptying of the bladder for urinary retention. Gradual emptying did not reduce the risk of hematuria or circulatory collapse. Therefore, there is no need to prefer gradual over rapid emptying, which is both easy and safe. © 2013 S. Karger AG, Basel.

Radiofrequency and Microwave Ablation Compared to Systemic Chemotherapy and to Partial Hepatectomy in the Treatment of Colorectal Liver Metastases: A Systematic Review and Meta-Analysis.

PubMed

Meijerink, Martijn R; Puijk, Robbert S; van Tilborg, Aukje A J M; Henningsen, Kirsten Holdt; Fernandez, Llenalia Garcia; Neyt, Mattias; Heymans, Juanita; Frankema, Jacqueline S; de Jong, Koert P; Richel, Dick J; Prevoo, Warner; Vlayen, Joan

2018-04-17

To assess safety and outcome of radiofrequency ablation (RFA) and microwave ablation (MWA) as compared to systemic chemotherapy and partial hepatectomy (PH) in the treatment of colorectal liver metastases (CRLM). MEDLINE, Embase and the Cochrane Library were searched. Randomized trials and comparative observational studies with multivariate analysis and/or matching were included. Guidelines from National Guideline Clearinghouse and Guidelines International Network were assessed using the AGREE II instrument. The search revealed 3530 records; 328 were selected for full-text review; 48 were included: 8 systematic reviews, 2 randomized studies, 26 comparative observational studies, 2 guideline-articles and 10 case series; in addition 13 guidelines were evaluated. Literature to assess the effectiveness of ablation was limited. RFA + systemic chemotherapy was superior to chemotherapy alone. PH was superior to RFA alone but not to RFA + PH or to MWA. Compared to PH, RFA showed fewer complications, MWA did not. Outcomes were subject to residual confounding since ablation was only employed for unresectable disease. The results from the EORTC-CLOCC trial, the comparable survival for ablation + PH versus PH alone, the potential to induce long-term disease control and the low complication rate argue in favour of ablation over chemotherapy alone. Further randomized comparisons of ablation to current-day chemotherapy alone should therefore be considered unethical. Hence, the highest achievable level of evidence for unresectable CRLM seems reached. The apparent selection bias from previous studies and the superior safety profile mandate the setup of randomized controlled trials comparing ablation to surgery.

Evaluation of App-Based Serious Gaming as a Training Method in Teaching Chest Tube Insertion to Medical Students: Randomized Controlled Trial.

PubMed

Haubruck, Patrick; Nickel, Felix; Ober, Julian; Walker, Tilman; Bergdolt, Christian; Friedrich, Mirco; Müller-Stich, Beat Peter; Forchheim, Franziska; Fischer, Christian; Schmidmaier, Gerhard; Tanner, Michael C

2018-05-21

The insertion of a chest tube should be as quick and accurate as possible to maximize the benefit and minimize possible complications for the patient. Therefore, comprehensive training and assessment before an emergency situation are essential for proficiency in chest tube insertion. Serious games have become more prevalent in surgical training because they enable students to study and train a procedure independently, and errors made have no effect on patients. However, up-to-date evidence regarding the effect of serious games on performance in procedures in emergency medicine remains scarce. The aim of this study was to investigate the serious gaming approach in teaching medical students an emergency procedure (chest tube insertion) using the app Touch Surgery and a modified objective structural assessment of technical skills (OSATS). In a prospective, rater-blinded, randomized controlled trial, medical students were randomized into two groups: intervention group or control group. Touch Surgery has been established as an innovative and cost-free app for mobile devices. The fully automatic software enables users to train medical procedures and afterwards self-assess their training effort. The module chest tube insertion teaches each key step in the insertion of a chest tube and enables users the meticulous application of a chest tube. In contrast, the module "Thoracocentesis" discusses a basic thoracocentesis. All students attended a lecture regarding chest tube insertion (regular curriculum) and afterwards received a Touch Surgery training lesson: intervention group used the module chest tube insertion and the control group used Thoracocentesis as control training. Participants' performance in chest tube insertion on a porcine model was rated on-site via blinded face-to-face rating and via video recordings using a modified OSATS tool. Afterwards, every participant received an individual questionnaire for self-evaluation. Here, trainees gave information about their individual training level, as well as previous experiences, gender, and hobbies. Primary end point was operative performance during chest tube insertion by direct observance. A total of 183 students enrolled, 116 students participated (63.4%), and 21 were excluded because of previous experiences in chest tube insertion. Students were randomized to the intervention group (49/95, 52%) and control group (46/95, 48%). The intervention group performed significantly better than the control group (Intervention group: 38.0 [I 50 =7.0] points; control group: 30.5 [I 50 =8.0] points; P<.001). The intervention group showed significantly improved economy of time and motion (P=.004), needed significantly less help (P<.001), and was more confident in handling of instruments (P<.001) than the control group. The results from this study show that serious games are a valid and effective tool in education of operative performance in chest tube insertion. We believe that serious games should be implemented in the surgical curriculum, as well as residency programs, in addition to traditional learning methods. German Clinical Trials Register (DRKS) DRKS00009994; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00009994 (Archived by Webcite at http://www.webcitation.org/6ytWF1CWg). ©Patrick Haubruck, Felix Nickel, Julian Ober, Tilman Walker, Christian Bergdolt, Mirco Friedrich, Beat Peter Müller-Stich, Franziska Forchheim, Christian Fischer, Gerhard Schmidmaier, Michael C Tanner. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 21.05.2018.

The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial.

PubMed

Mühlmann, Charlotte; Madsen, Trine; Hjorthøj, Carsten; Kerkhof, Ad; Nordentoft, Merete; Erlangsen, Annette

2017-01-28

Suicidal thoughts are common, causing distress for millions of people all over the world. However, people with suicidal thoughts might not access support due to financial restraints, stigma or a lack of available treatment offers. Self-help programs provided online could overcome these barriers, and previous efforts show promising results in terms of reducing suicidal thoughts. This study aims to examine the effectiveness of an online self-help intervention in reducing suicidal thoughts among people at risk of suicide. The Danish Self-help Online against Suicidal thoughts (SOS) trial is a partial replication of a previously conducted Dutch trial. A randomized, waiting-list controlled trial with 1:1 allocation ratio will be carried out. A total of 438 people with suicidal thoughts will be recruited from the Danish suicide hotline, The Lifeline's, website and allocated to the intervention condition (N = 219) or the control condition (N = 219). The intervention condition consists of a 6-week, Internet-based self-help therapy intervention. The format of the intervention is self-help, but the participants can be guided by the trial manager. The control condition consists of a waiting-list assignment for 32 weeks. The primary outcomes are frequency and intensity of suicidal thoughts. Secondary outcome measures include depressive symptoms, hopelessness, worrying, quality of life, costs related to health care utilization and production loss. Number of deliberate self-harm episodes, suicides and deaths will, as well as the participant's evaluation of the intervention and the experience of negative effects, be investigated. Assessments will be conducted over the intervention website through self-report questionnaires at baseline, 2 weeks, 4 weeks, 6 weeks and 32 weeks (6 months post intervention). If we find the intervention to be linked to reductions in suicidal thoughts, this will strengthen the evidence that online self-help interventions are relevant tools for people with suicidal thoughts. ClinicalTrials.gov, NCT02872610 . Registered on 9 August 2016.

Conserved directed percolation: exact quasistationary distribution of small systems and Monte Carlo simulations

NASA Astrophysics Data System (ADS)

César Mansur Filho, Júlio; Dickman, Ronald

2011-05-01

We study symmetric sleepy random walkers, a model exhibiting an absorbing-state phase transition in the conserved directed percolation (CDP) universality class. Unlike most examples of this class studied previously, this model possesses a continuously variable control parameter, facilitating analysis of critical properties. We study the model using two complementary approaches: analysis of the numerically exact quasistationary (QS) probability distribution on rings of up to 22 sites, and Monte Carlo simulation of systems of up to 32 000 sites. The resulting estimates for critical exponents β, \\beta /\

Does behaviour modification affect post-stroke risk factor control? Three-year follow-up of a randomized controlled trial.

PubMed

McManus, Julie Ann; Craig, Alison; McAlpine, Christine; Langhorne, Peter; Ellis, Graham

2009-02-01

Little is known about the long-term effectiveness after stroke of interventions for behaviour modification and ensuring concordance with therapies. We describe a follow-up study of a previous randomized controlled trial of a brief period of behaviour modification. The aim of this study was to determine outcomes three years after the initial intervention. Survivors of the original cohort were contacted and asked to attend for follow-up interview, within a geriatric day hospital. This study was carried out in the Geriatric Day Hospital at Stobhill Hospital, Balornock Road, Glasgow. Details of risk factor control, including blood pressure, cholesterol levels and diabetic control, were assessed. Questionnaires used in the initial study were repeated including the Geriatric Depression Scale score, Euroqol Perceived Health Status and Stroke Services Satisfaction Questionnaire. Primary outcome was collective risk factor control. Clinical outcomes including recurrent cerebrovascular events, medication persistence and perceived health status were also recorded. Mean length of follow-up was 3.6 years (SD 0.43). Of the 205 patients enrolled in the initial study, 102 patients attended for repeat interview(49 intervention/53 control). There were no significant differences in the percentage of controlled risk factors between groups (intervention 51.7% versus control 55.9%, P = 0.53). Similarities were observed in the number of recurrent clinical events and medication persistence between groups. No overall difference was observed in perceived health status, satisfaction with care or depression scores. Brief intervention with respect to behaviour modification and risk factor control does not appear to have any long-term benefit. These results must be cautiously interpreted in light of the small study number and further research is required.

Motor Sequence Learning-Induced Neural Efficiency in Functional Brain Connectivity

PubMed Central

Karim, Helmet T; Huppert, Theodore J; Erickson, Kirk I; Wollam, Mariegold E; Sparto, Patrick J; Sejdić, Ervin; VanSwearingen, Jessie M

2016-01-01

Previous studies have shown the functional neural circuitry differences before and after an explicitly learned motor sequence task, but have not assessed these changes during the process of motor skill learning. Functional magnetic resonance imaging activity was measured while participants (n=13) were asked to tap their fingers to visually presented sequences in blocks that were either the same sequence repeated (learning block) or random sequences (control block). Motor learning was associated with a decrease in brain activity during learning compared to control. Lower brain activation was noted in the posterior parietal association area and bilateral thalamus during the later periods of learning (not during the control). Compared to the control condition, we found the task-related motor learning was associated with decreased connectivity between the putamen and left inferior frontal gyrus and left middle cingulate brain regions. Motor learning was associated with changes in network activity, spatial extent, and connectivity. PMID:27845228

The culture and identity schedule a measure of cultural affiliation: acculturation, marginalization and schizophrenia.

PubMed

Bhugra, Dinesh; Leff, Julian; Mallett, Rosemarie; Morgan, Craig; Zhao, Jing-Hua

2010-09-01

Previous epidemiological studies have shown a high incidence of schizophrenia in African-Caribbeans in the UK, but not in Asians. We investigated the hypothesis that cultural adherence might protect the Asians against the stress of living in a majority white culture. The Culture and Identity Schedule (CANDID) was given to patients with a diagnosis of schizophrenia making their first contact with psychiatric services, and to a matched group of controls randomly selected from the general population. While the Asian patients displayed no drift away from the traditional values as espoused by their controls, the African-Caribbean patients were less traditional than their controls. The fact that a movement away from their traditional culture distinguishes African-Caribbean patients with a severe psychiatric illness, schizophrenia, from their mentally healthy controls strongly favours marginalization over biculturalism as an interpretation of this shift.

Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73).

PubMed

Ramsden, Christopher E; Zamora, Daisy; Majchrzak-Hong, Sharon; Faurot, Keturah R; Broste, Steven K; Frantz, Robert P; Davis, John M; Ringel, Amit; Suchindran, Chirayath M; Hibbeln, Joseph R

2016-04-12

To examine the traditional diet-heart hypothesis through recovery and analysis of previously unpublished data from the Minnesota Coronary Experiment (MCE) and to put findings in the context of existing diet-heart randomized controlled trials through a systematic review and meta-analysis. The MCE (1968-73) is a double blind randomized controlled trial designed to test whether replacement of saturated fat with vegetable oil rich in linoleic acid reduces coronary heart disease and death by lowering serum cholesterol. Recovered MCE unpublished documents and raw data were analyzed according to hypotheses prespecified by original investigators. Further, a systematic review and meta-analyses of randomized controlled trials that lowered serum cholesterol by providing vegetable oil rich in linoleic acid in place of saturated fat without confounding by concomitant interventions was conducted. One nursing home and six state mental hospitals in Minnesota, United States. Unpublished documents with completed analyses for the randomized cohort of 9423 women and men aged 20-97; longitudinal data on serum cholesterol for the 2355 participants exposed to the study diets for a year or more; 149 completed autopsy files. Serum cholesterol lowering diet that replaced saturated fat with linoleic acid (from corn oil and corn oil polyunsaturated margarine). Control diet was high in saturated fat from animal fats, common margarines, and shortenings. Death from all causes; association between changes in serum cholesterol and death; and coronary atherosclerosis and myocardial infarcts detected at autopsy. The intervention group had significant reduction in serum cholesterol compared with controls (mean change from baseline -13.8%v-1.0%; P<0.001). Kaplan Meier graphs showed no mortality benefit for the intervention group in the full randomized cohort or for any prespecified subgroup. There was a 22% higher risk of death for each 30 mg/dL (0.78 mmol/L) reduction in serum cholesterol in covariate adjusted Cox regression models (hazard ratio 1.22, 95% confidence interval 1.14 to 1.32; P<0.001). There was no evidence of benefit in the intervention group for coronary atherosclerosis or myocardial infarcts. Systematic review identified five randomized controlled trials for inclusion (n=10,808). In meta-analyses, these cholesterol lowering interventions showed no evidence of benefit on mortality from coronary heart disease (1.13, 0.83 to 1.54) or all cause mortality (1.07, 0.90 to 1.27). Available evidence from randomized controlled trials shows that replacement of saturated fat in the diet with linoleic acid effectively lowers serum cholesterol but does not support the hypothesis that this translates to a lower risk of death from coronary heart disease or all causes. Findings from the Minnesota Coronary Experiment add to growing evidence that incomplete publication has contributed to overestimation of the benefits of replacing saturated fat with vegetable oils rich in linoleic acid. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

High- and low-intensity exercise do not improve cognitive function after stroke: A randomized controlled trial.

PubMed

Tang, Ada; Eng, Janice J; Krassioukov, Andrei V; Tsang, Teresa S M; Liu-Ambrose, Teresa

2016-11-11

To determine the effects of high versus low-intensity exercise on cognitive function following stroke. Secondary analysis from a randomized controlled trial with blinded assessors. 50-80 years old, living in the community, > 1 year post-stroke. Participants were randomized into a high-intensity Aerobic Exercise or low-intensity non-aerobic Balance/Flexibility program. Both programs were 6 months long, with 3 60-min sessions/week. Verbal item and working memory, selective attention and conflict resolution, set shifting were assessed before and after the program. Forty-seven participants completed the study (22/25 in Aerobic Exercise group, 25/25 in Balance/Flexibility group). There was an improvement in verbal item memory in both groups (time effect p = 0.04), and no between-group differences in improvement in the other outcomes (p > 0.27). There was no association between pre-exercise cognitive function and post-exercise improvement. In contrast to a small body of previous research suggesting positive benefits of exercise on cognition post-stroke, the current study found that 6 months of high or low intensity exercise was not effective in improving cognitive function, specifically executive functions. Further research in this area is warranted to establish the effectiveness of post-stroke exercise programs on cognition, and examine the mechanisms that underlie these changes.

[Donepezil in patients with Alzheimer's disease--a critical appraisal of the AD2000 study].

PubMed

Kaiser, Thomas; Florack, Christiane; Franz, Heinrich; Sawicki, Peter T

2005-03-15

The AD2000 study was a randomized placebo-controlled trial, the effects of donepezil, a cholinesterase inhibitor, in patients with Alzheimer's disease. It was the first long-term RCT not sponsored by the pharmaceutical industry. The study did not show any significant effect on patient-relevant outcomes. However, donepezil had a significant effect on cognitive scores. More patients taking donepezil stopped treatment due to adverse events, even when taking only 5 mg once daily. There are major concerns regarding the conduction of the AD2000 study as well as the presentation of the results. Much less patients than previously planned have been recruited, resulting in a low statistical power to detect a significant difference between both treatments. In addition, no true intention-to-treat analysis based on the first randomization is presented. The validity of the AD2000 trial has to be questioned. However, there is still insufficient evidence to support the claim that cholinesterase inhibitors have beneficial effects on patient-relevant outcomes in patients with Alzheimer's disease. The change of cognitive performance as measured by different scales does not necessarily correspond to substantial changes in patient-relevant outcomes. In conclusion, the widespread use of cholinesterase inhibitors in patients with Alzheimer's disease is not supported by current evidence. Long-term-randomized controlled trials focusing on patient-relevant outcomes instead of cognitive scores are urgently needed.

Psychological Intervention for Improving Cognitive Function in Cancer Survivors: A Literature Review and Randomized Controlled Trial

PubMed Central

King, Summer; Green, Heather Joy

2015-01-01

Although the impact of cancer and associated treatments on cognitive functioning is becoming an increasingly recognized problem, there are few published studies that have investigated psychological interventions to address this issue. A waitlist randomized controlled trial methodology was used to assess the efficacy of a group cognitive rehabilitation intervention (“ReCog”) that successfully targeted cancer-related cognitive decline in previously published pilot research. Participants were 29 cancer survivors who were randomly allocated to either the intervention group or a waitlist group who received the intervention at a later date, and 16 demographically matched community volunteers with no history of cancer (trial registration ACTRN12615000009516, available at http://www.ANZCTR.org.au/ACTRN12615000009516.aspx). The study was the first to include an adapted version of the Traumatic Brain Injury Self-Efficacy Scale to assess cognitive self-efficacy (CSE) in people who have experienced cancer. Results revealed participating in the intervention was associated with significantly faster performance on one objective cognitive task that measures processing speed and visual scanning. Significantly larger improvements for the intervention group were also found on measures of perceived cognitive impairments and CSE. There was some evidence to support the roles of CSE and illness perceptions as potential mechanisms of change for the intervention. Overall, the study provided additional evidence of feasibility and efficacy of group psychological intervention for targeting cancer-related cognitive decline. PMID:25859431

Association Splitting: A randomized controlled trial of a new method to reduce craving among inpatients with alcohol dependence.

PubMed

Schneider, Brooke C; Moritz, Steffen; Hottenrott, Birgit; Reimer, Jens; Andreou, Christina; Jelinek, Lena

2016-04-30

Association Splitting, a novel cognitive intervention, was tested in patients with alcohol dependence as an add-on intervention in an initial randomized controlled trial. Preliminary support for Association Splitting has been found in patients with obsessive-compulsive disorder, as well as in an online pilot study of patients with alcohol use disorders. The present variant sought to reduce craving by strengthening neutral associations with alcohol-related stimuli, thus, altering cognitive networks. Eighty-four inpatients with verified diagnoses of alcohol dependence, who were currently undergoing inpatient treatment, were randomly assigned to Association Splitting or Exercise Therapy. Craving was measured at baseline, 4-week follow-up, and six months later with the Obsessive-Compulsive Drinking Scale (primary outcome) and the Alcohol Craving Questionnaire. There was no advantage for Association Splitting after three treatment sessions relative to Exercise Therapy. Among Association Splitting participants, 51.9% endorsed a subjective decline in craving and 88.9% indicated that they would use Association Splitting in the future. Despite high acceptance, an additional benefit of Association Splitting beyond standard inpatient treatment was not found. Given that participants were concurrently undergoing inpatient treatment and Association Splitting has previously shown moderate effects, modification of the study design may improve the potential to detect significant effects in future trials. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Adjunctive α-lipoic acid reduces weight gain compared with placebo at 12 weeks in schizophrenic patients treated with atypical antipsychotics: a double-blind randomized placebo-controlled study.

PubMed

Kim, Nam Wook; Song, Yul-Mai; Kim, Eosu; Cho, Hyun-Sang; Cheon, Keun-Ah; Kim, Su Jin; Park, Jin Young

2016-09-01

α-Lipoic acid (ALA) has been reported to be effective in reducing body weight in rodents and obese patients. Our previous open trial showed that ALA may play a role in reducing weight gain in patients with schizophrenia on atypical antipsychotics. The present study evaluated the efficacy of ALA in reducing weight and BMI in patients with schizophrenia who had experienced significant weight gain since taking atypical antipsychotics. In a 12-week, double-blind randomized placebo-controlled study, 22 overweight and clinically stable patients with schizophrenia were randomly assigned to receive ALA or placebo. ALA was administered at 600-1800 mg, as tolerated. Weight, BMI, abdomen fat area measured by computed tomography, and metabolic values were determined. Adverse effects were also assessed to examine safety. Overall, 15 patients completed 12 weeks of treatment. There was significant weight loss and decreased visceral fat levels in the ALA group compared with the placebo group. There were no instances of psychopathologic aggravation or severe ALA-associated adverse effects. ALA was effective in reducing weight and abdominal obesity in patients with schizophrenia who had experienced significant weight gain since beginning an atypical antipsychotic regimen. Moreover, ALA was well tolerated throughout this study. ALA might play an important role as an adjunctive treatment in decreasing obesity in patients who take atypical antipsychotics.

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

PubMed Central

Baker, Elizabeth A.; Robinson, Robert G.

2014-01-01

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

Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial.

PubMed

Harada, Tasuku; Momoeda, Mikio

2016-12-01

To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea. Placebo-controlled, double-blind, randomized trial. Clinical trial sites. Two hundred fifteen subjects with dysmenorrhea. Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles. Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics. The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred. The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea. NCT01129102. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Effect of community health clubs on child diarrhoea in western Rwanda: cluster-randomised controlled trial.

PubMed

Sinharoy, Sheela S; Schmidt, Wolf-Peter; Wendt, Ronald; Mfura, Leodomir; Crossett, Erin; Grépin, Karen A; Jack, William; Rwabufigiri, Bernard Ngabo; Habyarimana, James; Clasen, Thomas

2017-07-01

Community health clubs are multi-session village-level gatherings led by trained facilitators and designed to promote healthy behaviours mainly related to water, sanitation, and hygiene. They have been implemented in several African and Asian countries but have never been evaluated rigorously. We aimed to evaluate the effect of two versions of the community health club model on child health and nutrition outcomes. We did a cluster-randomised trial in Rusizi district, western Rwanda. We defined villages as clusters. We assessed villages for eligibility then randomly selected 150 for the study using a simple random sampling routine in Stata. We stratified villages by wealth index and by the proportion of children younger than 2 years with caregiver-reported diarrhoea within the past 7 days. We randomly allocated these villages to three study groups: no intervention (control; n=50), eight community health club sessions (Lite intervention; n=50), or 20 community health club sessions (Classic intervention; n=50). Households in these villages were enrolled in 2013 for a baseline survey, then re-enrolled in 2015 for an endline survey. The primary outcome was caregiver-reported diarrhoea within the previous 7 days in children younger than 5 years. Analysis was by intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT01836731. At the baseline survey undertaken between May, 2013, and August, 2013, 8734 households with children younger than 5 years of age were enrolled. At the endline survey undertaken between Sept 21, 2015, and Dec 22, 2015, 7934 (91%) of the households were re-enrolled. Among children younger than 5 years, the prevalence of caregiver-reported diarrhoea in the previous 7 days was 514 (14%) of 3616 assigned the control, 453 (14%) of 3196 allocated the Lite intervention (prevalence ratio compared with control 0·97, 95% CI 0·81-1·16; p=0·74), and 495 (14%) of 3464 assigned the Classic intervention (prevalence ratio compared with control 0·99, 0·85-1·15; p=0·87). Community health clubs, in this setting in western Rwanda, had no effect on caregiver-reported diarrhoea among children younger than 5 years. Our results question the value of implementing this intervention at scale for the aim of achieving health gains. Bill & Melinda Gates Foundation. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial.

PubMed

Leem, Jungtae; Lee, Seung Min Kathy; Park, Jun Hyeong; Lee, Suji; Chung, Hyemoon; Lee, Jung Myung; Kim, Weon; Lee, Sanghoon; Woo, Jong Shin

2017-07-11

The purpose of this trial is to evaluate the effectiveness and safety of electroacupuncture in the treatment of acute decompensated heart failure compared with sham electroacupuncture. This protocol is for a randomized, sham controlled, patient- and assessor-blinded, parallel group, single center clinical trial that can overcome the limitations of previous trials examining acupuncture and heart failure. Forty-four acute decompensated heart failure patients admitted to the cardiology ward will be randomly assigned into the electroacupuncture treatment group (n = 22) or the sham electroacupuncture control group (n = 22). Participants will receive electroacupuncture treatment for 5 days of their hospital stay. The primary outcome of this study is the difference in total diuretic dose between the two groups during hospitalization. On the day of discharge, follow-up heart rate variability, routine blood tests, cardiac biomarkers, high-sensitivity C-reactive protein (hs-CRP) level, and N-terminal pro b-type natriuretic peptide (NT-pro BNP) level will be assessed. Four weeks after discharge, hs-CRP, NT-pro BNP, heart failure symptoms, quality of life, and a pattern identification questionnaire will be used for follow-up analysis. Six months after discharge, major cardiac adverse events and cardiac function measured by echocardiography will be assessed. Adverse events will be recorded during every visit. The result of this clinical trial will offer evidence of the effectiveness and safety of electroacupuncture for acute decompensated heart failure. Clinical Research Information Service: KCT0002249 .

Online attention modification for social anxiety disorder: replication of a randomized controlled trial.

PubMed

Carleton, R Nicholas; Teale Sapach, Michelle J N; Oriet, Chris; LeBouthillier, Daniel M

2017-01-01

Social anxiety disorder (SAD) models posit vigilance for external social threat cues and exacerbated self-focused attention as key in disorder development and maintenance. Evidence indicates a modified dot-probe protocol may reduce symptoms of SAD; however, the efficacy when compared to a standard protocol and long-term maintenance of treatment gains remains unclear. Furthermore, the efficacy of such protocols on SAD-related constructs remains relatively unknown. The current investigation clarified these associations using a randomized control trial replicating and extending previous research. Participants with SAD (n = 113; 71% women) were randomized to complete a standard (i.e. control) or modified (i.e. active) dot-probe protocol consisting of 15-min sessions twice weekly for four weeks. Self-reported symptoms were measured at baseline, post-treatment, and 4-month and 8-month follow-ups. Hierarchical linear modeling indicated significant self-reported reductions in symptoms of social anxiety, fear of negative evaluation, trait anxiety, and depression, but no such reductions in fear of positive evaluation. Symptom changes did not differ based on condition and were maintained at 8-month follow-up. Attentional biases during the dot-probe task were not related to symptom change. Overall, our results replicate support for the efficacy of both protocols in reducing symptoms of SAD and specific related constructs, and suggest a role of exposure, expectancy, or practice effects, rather than attention modification, in effecting such reductions. The current results also support distinct relationships between fears of negative and positive evaluation and social anxiety. Further research focused on identifying the mechanisms of change in attention modification protocols appears warranted.

Effect of Rivastigmine Augmentation in Treatment of Male Patients With Combat-Related Chronic Posttraumatic Stress Disorder: A Randomized Controlled Trial.

PubMed

Rezaei Ardani, Amir; Hosseini, Golkoo; Fayyazi Bordbar, Mohammad Reza; Talaei, Ali; Mostafavi Toroghi, Hesam

2017-02-01

Posttraumatic stress disorder (PTSD) is one of the chronic and disabling psychiatric disorders, particularly in combat veterans. In a case series, rivastigmine was suggested to be an effective augmentation in treatment of PTSD. The aim of the present study was to evaluate this finding in a randomized controlled trial. A 12-week, double-blind, placebo-controlled clinical trial was performed on 36 male patients (aged 42-60 years) diagnosed with chronic, combat-related PTSD. Subjects were screened for apparent cognitive deficits by means of Mini-Mental State Examination. All patients received selective serotonin reuptake inhibitors plus sodium valproate for 4 weeks and then reevaluated. Subjects who did not show adequate response were randomly assigned into 3 groups receiving rivastigmine (up to 6 mg/d), placebo, or the prior treatment regimen. Efficacy of medication was measured by administering PTSD Check List-Military Version at baseline and weeks 2, 4, 8, and 12. Collected data were analyzed by analysis of variance and repeated measurement. Reported differences were considered significant at the level of 0.05 or less. The 3 groups showed statistically significant reductions in the total PTSD Check List-Military Version, avoidance subscale, and the reexperience subscale but not in the hyperarousal subscale. No significant differences were found between the 3 groups. In contrast to the previous case series, findings of the current study did not support the efficacy of adjunctive rivastigmine in treatment of PTSD. This hypothetically could be due to the fact that all the study's subjects scored higher than 25 on Mini-Mental State Examination.