Synaptic Tagging During Memory Allocation

PubMed Central

Rogerson, Thomas; Cai, Denise; Frank, Adam; Sano, Yoshitake; Shobe, Justin; Aranda, Manuel L.; Silva, Alcino J.

2014-01-01

There is now compelling evidence that the allocation of memory to specific neurons (neuronal allocation) and synapses (synaptic allocation) in a neurocircuit is not random and that instead specific mechanisms, such as increases in neuronal excitability and synaptic tagging and capture, determine the exact sites where memories are stored. We propose an integrated view of these processes, such that neuronal allocation, synaptic tagging and capture, spine clustering and metaplasticity reflect related aspects of memory allocation mechanisms. Importantly, the properties of these mechanisms suggest a set of rules that profoundly affect how memories are stored and recalled. PMID:24496410

47 CFR 1.1417 - Allocation of Unusable Space Costs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 1 2014-10-01 2014-10-01 false Allocation of Unusable Space Costs. 1.1417... by Random Selection Pole Attachment Complaint Procedures § 1.1417 Allocation of Unusable Space Costs... providing unusable space on a pole so that such apportionment equals two-thirds of the costs of providing...

47 CFR 1.1417 - Allocation of Unusable Space Costs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 1 2013-10-01 2013-10-01 false Allocation of Unusable Space Costs. 1.1417... by Random Selection Pole Attachment Complaint Procedures § 1.1417 Allocation of Unusable Space Costs... providing unusable space on a pole so that such apportionment equals two-thirds of the costs of providing...

47 CFR 1.1417 - Allocation of Unusable Space Costs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 1 2012-10-01 2012-10-01 false Allocation of Unusable Space Costs. 1.1417... by Random Selection Pole Attachment Complaint Procedures § 1.1417 Allocation of Unusable Space Costs... providing unusable space on a pole so that such apportionment equals two-thirds of the costs of providing...

The Effect of Trimethoprim on Serum Folate Levels in Humans: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Meidahl Petersen, Kasper; Eplov, Kasper; Kjær Nielsen, Torben; Jimenez-Solem, Espen; Petersen, Morten; Broedbaek, Kasper; Daugaard Popik, Sara; Kallehave Hansen, Lina; Enghusen Poulsen, Henrik; Trærup Andersen, Jon

2016-01-01

Trimethoprim antagonize the actions of folate by inhibition of dihydrofolate reductase. This could diminish serum folate levels in humans and causes folate deficiency in some patients. We conducted a randomized, double-blind, placebo-controlled trial, to investigate the effect of trimethoprim on serum folate levels in healthy participants after a 7-day trial period. Thirty young, healthy males were randomly allocated to receive trimethoprim, 200 mg twice daily, and 30 were randomly allocated to placebo. Before trial initiation, participant numbers were given randomly generated treatment allocations within sealed opaque envelopes. Participants and all staff were kept blinded to treatment allocations during the trial. Serum folate was measured at baseline and at end of trial. In the 58 participants analyzed (30 in the trimethoprim group and 28 in the placebo group), 8 had folate deficiency at baseline. Within the trimethoprim group, serum folate was significantly decreased (P = 0.018) after the trial. We found a mean decrease in serum folate among trimethoprim exposed of 1.95 nmol/L, compared with a 0.21 nmol/L mean increase in the placebo group (P = 0.040). The proportion of folate-deficient participants increased significantly within the trimethoprim group (P = 0.034). No serious adverse events were observed. In conclusion, we found that a daily dose of 400 mg trimethoprim for 7 days significantly lowered serum folate levels in healthy study participants.

RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

PubMed

Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

2015-08-01

Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform

PubMed Central

Gu, Jing; Wang, Qi; Wang, Xiaogang; Li, Hailong; Gu, Mei; Ming, Haixia; Dong, Xiaoli; Yang, Kehu; Wu, Hongyan

2014-01-01

Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration. PMID:24688591

Assessment of Registration Information on Methodological Design of Acupuncture RCTs: A Review of 453 Registration Records Retrieved from WHO International Clinical Trials Registry Platform.

PubMed

Gu, Jing; Wang, Qi; Wang, Xiaogang; Li, Hailong; Gu, Mei; Ming, Haixia; Dong, Xiaoli; Yang, Kehu; Wu, Hongyan

2014-01-01

Background. This review provides the first methodological information assessment of protocol of acupuncture RCTs registered in WHO International Clinical Trials Registry Platform (ICTRP). Methods. All records of acupuncture RCTs registered in the ICTRP have been collected. The methodological design assessment involved whether the randomization methods, allocation concealment, and blinding were adequate or not based on the information of registration records (protocols of acupuncture RCTs). Results. A total of 453 records, found in 11 registries, were examined. Methodological details were insufficient in registration records; there were 76.4%, 89.0%, and 21.4% records that did not provide information on randomization methods, allocation concealment, and blinding respectively. The proportions of adequate randomization methods, allocation concealment, and blinding were only 107 (23.6%), 48 (10.6%), and 210 (46.4%), respectively. The methodological design improved year by year, especially after 2007. Additionally, methodology of RCTs with ethics approval was clearly superior to those without ethics approval and different among registries. Conclusions. The overall methodological design based on registration records of acupuncture RCTs is not very well but improved year by year. The insufficient information on randomization methods, allocation concealment, and blinding maybe due to the relevant description is not taken seriously in acupuncture RCTs' registration.

Trends in E & G Expenditure Allocations. Indicators of Recession or Increased Productivity?

ERIC Educational Resources Information Center

Minter, John

1992-01-01

A random sample of 300 financial officers at public and independent 4-year and public 2-year institutions reveal their projected fiscal 1992 year-end expenditures and 1992-93 budget allocations. Summarized in chart form are the findings on changes in growth rates on salary and wage allocations for a variety of institutional functions. (GLR)

Optimizing Utilization of Detectors

DTIC Science & Technology

2016-03-01

provide a quantifiable process to determine how much time should be allocated to each task sharing the same asset . This optimized expected time... allocation is calculated by numerical analysis and Monte Carlo simulation. Numerical analysis determines the expectation by involving an integral and...determines the optimum time allocation of the asset by repeatedly running experiments to approximate the expectation of the random variables. This

Evaluation of the procedure 1A component of the 1980 US/Canada wheat and barley exploratory experiment

NASA Technical Reports Server (NTRS)

Chapman, G. M. (Principal Investigator); Carnes, J. G.

1981-01-01

Several techniques which use clusters generated by a new clustering algorithm, CLASSY, are proposed as alternatives to random sampling to obtain greater precision in crop proportion estimation: (1) Proportional Allocation/relative count estimator (PA/RCE) uses proportional allocation of dots to clusters on the basis of cluster size and a relative count cluster level estimate; (2) Proportional Allocation/Bayes Estimator (PA/BE) uses proportional allocation of dots to clusters and a Bayesian cluster-level estimate; and (3) Bayes Sequential Allocation/Bayesian Estimator (BSA/BE) uses sequential allocation of dots to clusters and a Bayesian cluster level estimate. Clustering in an effective method in making proportion estimates. It is estimated that, to obtain the same precision with random sampling as obtained by the proportional sampling of 50 dots with an unbiased estimator, samples of 85 or 166 would need to be taken if dot sets with AI labels (integrated procedure) or ground truth labels, respectively were input. Dot reallocation provides dot sets that are unbiased. It is recommended that these proportion estimation techniques are maintained, particularly the PA/BE because it provides the greatest precision.

Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes.

PubMed

Fransen, Marlene; Nairn, Lillias; Winstanley, Julie; Lam, Paul; Edmonds, John

2007-04-15

To determine whether Tai Chi or hydrotherapy classes for individuals with chronic symptomatic hip or knee osteoarthritis (OA) result in measurable clinical benefits. A randomized controlled trial was conducted among 152 older persons with chronic symptomatic hip or knee OA. Participants were randomly allocated for 12 weeks to hydrotherapy classes (n = 55), Tai Chi classes (n = 56), or a waiting list control group (n = 41). Outcomes were assessed 12 and 24 weeks after randomization and included pain and physical function (Western Ontario and McMaster Universities Osteoarthritis Index), general health status (Medical Outcomes Study Short Form 12 Health Survey [SF-12], version 2), psychological well-being, and physical performance (Up and Go test, 50-foot walk time, timed stair climb). At 12 weeks, compared with controls, participants allocated to hydrotherapy classes demonstrated mean improvements (95% confidence interval) of 6.5 (0.4, 12.7) and 10.5 (3.6, 14.5) for pain and physical function scores (range 0-100), respectively, whereas participants allocated to Tai Chi classes demonstrated improvements of 5.2 (-0.8, 11.1) and 9.7 (2.8, 16.7), respectively. Both class allocations achieved significant improvements in the SF-12 physical component summary score, but only allocation to hydrotherapy achieved significant improvements in the physical performance measures. All significant improvements were sustained at 24 weeks. In this almost exclusively white sample, class attendance was higher for hydrotherapy, with 81% attending at least half of the available 24 classes, compared with 61% for Tai Chi. Access to either hydrotherapy or Tai Chi classes can provide large and sustained improvements in physical function for many older, sedentary individuals with chronic hip or knee OA.

Reactive Power Pricing Model Considering the Randomness of Wind Power Output

NASA Astrophysics Data System (ADS)

Dai, Zhong; Wu, Zhou

2018-01-01

With the increase of wind power capacity integrated into grid, the influence of the randomness of wind power output on the reactive power distribution of grid is gradually highlighted. Meanwhile, the power market reform puts forward higher requirements for reasonable pricing of reactive power service. Based on it, the article combined the optimal power flow model considering wind power randomness with integrated cost allocation method to price reactive power. Meanwhile, considering the advantages and disadvantages of the present cost allocation method and marginal cost pricing, an integrated cost allocation method based on optimal power flow tracing is proposed. The model realized the optimal power flow distribution of reactive power with the minimal integrated cost and wind power integration, under the premise of guaranteeing the balance of reactive power pricing. Finally, through the analysis of multi-scenario calculation examples and the stochastic simulation of wind power outputs, the article compared the results of the model pricing and the marginal cost pricing, which proved that the model is accurate and effective.

Methodological reporting of randomized clinical trials in respiratory research in 2010.

PubMed

Lu, Yi; Yao, Qiuju; Gu, Jie; Shen, Ce

2013-09-01

Although randomized controlled trials (RCTs) are considered the highest level of evidence, they are also subject to bias, due to a lack of adequately reported randomization, and therefore the reporting should be as explicit as possible for readers to determine the significance of the contents. We evaluated the methodological quality of RCTs in respiratory research in high ranking clinical journals, published in 2010. We assessed the methodological quality, including generation of the allocation sequence, allocation concealment, double-blinding, sample-size calculation, intention-to-treat analysis, flow diagrams, number of medical centers involved, diseases, funding sources, types of interventions, trial registration, number of times the papers have been cited, journal impact factor, journal type, and journal endorsement of the CONSORT (Consolidated Standards of Reporting Trials) rules, in RCTs published in 12 top ranking clinical respiratory journals and 5 top ranking general medical journals. We included 176 trials, of which 93 (53%) reported adequate generation of the allocation sequence, 66 (38%) reported adequate allocation concealment, 79 (45%) were double-blind, 123 (70%) reported adequate sample-size calculation, 88 (50%) reported intention-to-treat analysis, and 122 (69%) included a flow diagram. Multivariate logistic regression analysis revealed that journal impact factor ≥ 5 was the only variable that significantly influenced adequate allocation sequence generation. Trial registration and journal impact factor ≥ 5 significantly influenced adequate allocation concealment. Medical interventions, trial registration, and journal endorsement of the CONSORT statement influenced adequate double-blinding. Publication in one of the general medical journal influenced adequate sample-size calculation. The methodological quality of RCTs in respiratory research needs improvement. Stricter enforcement of the CONSORT statement should enhance the quality of RCTs.

Dynamic Resource Allocation and Access Class Barring Scheme for Delay-Sensitive Devices in Machine to Machine (M2M) Communications.

PubMed

Li, Ning; Cao, Chao; Wang, Cong

2017-06-15

Supporting simultaneous access of machine-type devices is a critical challenge in machine-to-machine (M2M) communications. In this paper, we propose an optimal scheme to dynamically adjust the Access Class Barring (ACB) factor and the number of random access channel (RACH) resources for clustered machine-to-machine (M2M) communications, in which Delay-Sensitive (DS) devices coexist with Delay-Tolerant (DT) ones. In M2M communications, since delay-sensitive devices share random access resources with delay-tolerant devices, reducing the resources consumed by delay-sensitive devices means that there will be more resources available to delay-tolerant ones. Our goal is to optimize the random access scheme, which can not only satisfy the requirements of delay-sensitive devices, but also take the communication quality of delay-tolerant ones into consideration. We discuss this problem from the perspective of delay-sensitive services by adjusting the resource allocation and ACB scheme for these devices dynamically. Simulation results show that our proposed scheme realizes good performance in satisfying the delay-sensitive services as well as increasing the utilization rate of the random access resources allocated to them.

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.

Perioperative Aspirin for Prevention of Venous Thromboembolism: The PeriOperative ISchemia Evaluation-2 Trial and a Pooled Analysis of the Randomized Trials.

PubMed

Eikelboom, John W; Kearon, Clive; Guyatt, Gordon; Sessler, Daniel I; Yusuf, Salim; Cook, Deborah; Douketis, James; Patel, Ameen; Kurz, Andrea; Allard, Rene; Jones, Philip M; Dennis, Rodolfo J; Painter, Thomas W; Bergese, Sergio D; Leslie, Kate; Wijeysundera, Duminda N; Balasubramanian, Kumar; Duceppe, Emmanuelle; Miller, Scott; Diedericks, Johan; Devereaux, P J

2016-12-01

The PeriOperative ISchemia Evaluation-2 (POISE-2) trial compared aspirin with placebo after noncardiac surgery. The authors randomly assigned 10,010 patients undergoing noncardiac surgery to receive 200 mg aspirin or placebo 2 to 4 h before surgery and then 100 mg aspirin daily or placebo daily for up to 30 days after surgery. Herein, the authors report the effect of aspirin on venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, as well as an updated pooled analysis of randomized trials of antiplatelet therapy for VTE prevention in noncardiac surgery patients. Six thousand five hundred forty-eight patients (65.4%) received anticoagulant prophylaxis. VTE occurred in 53 patients (1.1%) allocated to aspirin and in 60 patients (1.2%) allocated to placebo (hazard ratio, 0.89; 95% CI, 0.61 to 1.28). Major or life-threatening bleeding occurred in 312 patients (6.3%) allocated to aspirin and in 256 patients (5.1%) allocated to placebo (hazard ratio, 1.22; 95% CI, 1.04 to 1.44). Concomitant use of anticoagulant prophylaxis did not modify the effect of aspirin on VTE or bleeding. Pooled analysis of the POISE-2 and Pulmonary Embolism Prevention trials demonstrated that symptomatic VTE occurred in 173 (1.3%) of 13,724 patients allocated to aspirin and in 246 (1.8%) of 13,730 patients allocated to placebo (odds ratio, 0.71; 95% CI, 0.56 to 0.89; heterogeneity P = 0.27; I = 17%); the impact of aspirin was very similar in those who did and did not receive pharmacologic prophylaxis. Pooled estimates for symptomatic VTE were similar to the pooled estimates for any deep vein thrombosis and pulmonary embolism from the POISE-2 trial, Pulmonary Embolism Prevention trial, and the Antiplatelet Trialists' Collaboration meta-analysis. Aspirin in the POISE-2 trial did not reduce VTE, but two thirds of patients received anticoagulant prophylaxis, there were few VTE events, and results were consistent with a wide range of aspirin effects. A pooled analysis of the randomized trials demonstrates evidence for the efficacy of aspirin for VTE prevention in hospitalized surgical patients.

Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness.

PubMed

Zhao, Wenle; Weng, Yanqiu; Wu, Qi; Palesch, Yuko

2012-01-01

To evaluate the performance of randomization designs under various parameter settings and trial sample sizes, and identify optimal designs with respect to both treatment imbalance and allocation randomness, we evaluate 260 design scenarios from 14 randomization designs under 15 sample sizes range from 10 to 300, using three measures for imbalance and three measures for randomness. The maximum absolute imbalance and the correct guess (CG) probability are selected to assess the trade-off performance of each randomization design. As measured by the maximum absolute imbalance and the CG probability, we found that performances of the 14 randomization designs are located in a closed region with the upper boundary (worst case) given by Efron's biased coin design (BCD) and the lower boundary (best case) from the Soares and Wu's big stick design (BSD). Designs close to the lower boundary provide a smaller imbalance and a higher randomness than designs close to the upper boundary. Our research suggested that optimization of randomization design is possible based on quantified evaluation of imbalance and randomness. Based on the maximum imbalance and CG probability, the BSD, Chen's biased coin design with imbalance tolerance method, and Chen's Ehrenfest urn design perform better than popularly used permuted block design, EBCD, and Wei's urn design. Copyright © 2011 John Wiley & Sons, Ltd.

Why does primary angioplasty not work in registries? Quantifying the susceptibility of real-world comparative effectiveness data to allocation bias.

PubMed

Sen, Sayan; Davies, Justin E; Malik, Iqbal S; Foale, Rodney A; Mikhail, Ghada W; Hadjiloizou, Nearchos; Hughes, Alun; Mayet, Jamil; Francis, Darrel P

2012-11-01

Meta-analysis of registries (comparative effectiveness research) shows that primary angioplasty and fibrinolysis have equivalent real-world survival. Yet, randomized, controlled trials consistently find primary angioplasty superior. Can unequal allocation of higher-risk patients in registries have masked primary angioplasty benefit? First, we constructed a model to demonstrate the potential effect of allocation bias. We then analyzed published registries (55022 patients) for allocation of higher-risk patients (Killip class ≥1) to determine whether the choice of reperfusion therapy was affected by the risk level of the patient. Meta-regression was used to examine the relationship between differences in allocation of high-risk patient to primary angioplasty or fibrinolysis and mortality. Initial modeling suggested that registry outcomes are sensitive to allocation bias of high-risk patients. Across the registries, the therapy receiving excess high-risk patients had worse mortality. Unequal distribution of high-risk status accounted for most of the between-registry variance (adjusted R(2)(meta)=83.1%). Accounting for differential allocation of higher-risk patients, primary angioplasty gave 22% lower mortality (odds ratio, 0.78; 95% confidence interval, 0.64-0.97; P=0.029). We derive a formula, called the number needed to abolish, highlighting situations in which comparative effectiveness studies are particularly vulnerable to this bias. In ST-segment elevation myocardial infarction, clinicians' preference for management of a few high-risk patients can shift mortality substantially. Comparative effectiveness research in any disease is vulnerable to this, especially diseases with an immediately identifiable high-risk subgroup that clinicians prefer to allocate to 1 therapy. For this reason, preliminary indications from registry-based comparative effectiveness research should be definitively tested by randomized, controlled trials.

Suicide prevention after traumatic brain injury: a randomized controlled trial of a program for the psychological treatment of hopelessness.

PubMed

Simpson, Grahame K; Tate, Robyn L; Whiting, Diane L; Cotter, Rachel E

2011-01-01

To evaluate the efficacy of a psychological treatment to reduce moderate to severe hopelessness after severe traumatic brain injury (TBI). Randomized controlled trial. Participants were aged between 18 and 65 years, experienced posttraumatic amnesia more than 1day and moderate to severe hopelessness (Beck Hopelessness Scale [BHS]) and/or suicide ideation. Intervention comprised a 20-hour manualized group cognitive behavior therapy program. Participants were randomly allocated using concealed allocation (treatment n = 8; wait-list n = 9); all remained in their allocated group. Outcome variables were collected by assessors blind to group allocation. No between-groups differences were observed on demographic, injury, cognitive, and psychosocial variables at baseline (time 1). A significant group-by-time interaction was found for BHS in the treatment group (F1,15 = 13.20, P = .002), reflecting a reduction in mean BHS scores between time 1 and time 2 (posttreatment) with no main effects for group or time. At 3-month follow-up (time 3), the treatment gains were maintained or improved for 75% (6/8) of participants. Secondary outcome variables (suicide ideation, depression, social problem solving, self-esteem, hopefulness) displayed no significant group-by-time interactions or main effects. This trial provides initial evidence for the efficacy of a psychological intervention in reducing hopelessness among long-term survivors with severe TBI.

TT : a program that implements predictor sort design and analysis

Treesearch

S. P. Verrill; D. W. Green; V. L. Herian

1997-01-01

In studies on wood strength, researchers sometimes replace experimental unit allocation via random sampling with allocation via sorts based on nondestructive measurements of strength predictors such as modulus of elasticity and specific gravity. This report documents TT, a computer program that implements recently published methods to increase the sensitivity of such...

ADAPTIVE MATCHING IN RANDOMIZED TRIALS AND OBSERVATIONAL STUDIES

PubMed Central

van der Laan, Mark J.; Balzer, Laura B.; Petersen, Maya L.

2014-01-01

SUMMARY In many randomized and observational studies the allocation of treatment among a sample of n independent and identically distributed units is a function of the covariates of all sampled units. As a result, the treatment labels among the units are possibly dependent, complicating estimation and posing challenges for statistical inference. For example, cluster randomized trials frequently sample communities from some target population, construct matched pairs of communities from those included in the sample based on some metric of similarity in baseline community characteristics, and then randomly allocate a treatment and a control intervention within each matched pair. In this case, the observed data can neither be represented as the realization of n independent random variables, nor, contrary to current practice, as the realization of n/2 independent random variables (treating the matched pair as the independent sampling unit). In this paper we study estimation of the average causal effect of a treatment under experimental designs in which treatment allocation potentially depends on the pre-intervention covariates of all units included in the sample. We define efficient targeted minimum loss based estimators for this general design, present a theorem that establishes the desired asymptotic normality of these estimators and allows for asymptotically valid statistical inference, and discuss implementation of these estimators. We further investigate the relative asymptotic efficiency of this design compared with a design in which unit-specific treatment assignment depends only on the units’ covariates. Our findings have practical implications for the optimal design and analysis of pair matched cluster randomized trials, as well as for observational studies in which treatment decisions may depend on characteristics of the entire sample. PMID:25097298

RECAL: A Computer Program for Selecting Sample Days for Recreation Use Estimation

Treesearch

D.L. Erickson; C.J. Liu; H. Ken Cordell; W.L. Chen

1980-01-01

Recreation Calendar (RECAL) is a computer program in PL/I for drawing a sample of days for estimating recreation use. With RECAL, a sampling period of any length may be chosen; simple random, stratified random, and factorial designs can be accommodated. The program randomly allocates days to strata and locations.

Sydney Playground Project: A Cluster-Randomized Trial to Increase Physical Activity, Play, and Social Skills

ERIC Educational Resources Information Center

Bundy, Anita; Engelen, Lina; Wyver, Shirley; Tranter, Paul; Ragen, Jo; Bauman, Adrian; Baur, Louise; Schiller, Wendy; Simpson, Judy M.; Niehues, Anita N.; Perry, Gabrielle; Jessup, Glenda; Naughton, Geraldine

2017-01-01

Background: We assessed the effectiveness of a simple intervention for increasing children's physical activity, play, perceived competence/social acceptance, and social skills. Methods: A cluster-randomized controlled trial was conducted, in which schools were the clusters. Twelve Sydney (Australia) primary schools were randomly allocated to…

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

USDA-ARS?s Scientific Manuscript database

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

Transcutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms and its impact on health-related quality of life in patients with Parkinson disease: a randomized controlled trial.

PubMed

Perissinotto, Maria Carolina; DʼAncona, Carlos Arturo Levi; Lucio, Adélia; Campos, Renata Martins; Abreu, Anelyssa

2015-01-01

A randomized controlled trial study was performed to evaluate the efficacy of transcutaneous tibial nerve stimulation (TTNS) and sham TTNS, in patients with Parkinson disease (PD) with lower urinary tract symptoms (LUTS). Randomized controlled trial. Thirteen patients with a diagnosis of PD and bothersome LUTS were randomly allocated to one of the following groups: Group I: TTNS group (n = 8) and group II: Sham group (n = 5). Both groups attended twice a week during 5 weeks; each session lasted 30 minutes. Eight patients received TTNS treatment and 5 subjects allocated to group II were managed with sham surface electrodes that delivered no electrical stimulation. Assessments were performed before and after the treatment; they included a 3-day bladder diary, Overactive Bladder Questionnaire (OAB-V8), and the International Consultation on Incontinence Quality of Life Questionnaire Short Form (ICIQ-SF), and urodynamic evaluation. Following 5 weeks of treatment, patients allocated to TTNS demonstrated statistically significant reductions in the number of urgency episodes (P = .004) and reductions in nocturia episodes (P < .01). Participants allocated to active treatment also showed better results after treatment in the OAB-V8 and ICIQ-SF scores (P < .01, respectively). Urodynamic testing revealed that patients in the active treatment group showed improvements in intravesical volume at strong desire to void (P < .05) and volume at urgency (P < .01) when compared to subjects in the sham treatment group. These findings suggest that TTNS is effective in the treatment of LUTS in patients with PD, reducing urgency and nocturia episodes and improving urodynamic parameters as well as symptom scores measured by the OAB-V8 and health-related quality-of-life scores measured by the ICIQ-SF.

Examining farmers' willingness to grow and allocate land for oilseed crops for biofuel production

USDA-ARS?s Scientific Manuscript database

The purpose of this paper is to determine farmers’ willingness to adopt and allocate land for growing non-food oilseeds as bio-energy crops across the western US. A mail survey was conducted in three regions of the western US from randomly selected wheat farmers. Data was analyzed using Heckman’s tw...

Deservingness and Equality in Children's Reward Allocations: Developmental Trends.

ERIC Educational Resources Information Center

Kaplan, Martin F.; Yehl, H. Michael

A total of 96 students (16 males and 16 females, chosen randomly from each of the first, fourth, and seventh grades of a grade school and a middle school,) allocated rewards in response to stimuli representing pairs of children differing in work output and effort. Stimulus materials consisted of: (1) a booklet containing nine drawings representing…

Predictor sort sampling, tight t`s, and the analysis of covariance : theory, tables, and examples

Treesearch

S. P. Verrill; D. W. Green

In recent years wood strength researchers have begun to replace experimental unit allocation via random sampling with allocation via sorts based on nondestructive measurements of strength predictors such as modulus of elasticity and specific gravity. Although this procedure has the potential of greatly increasing experimental sensitivity, as currently implemented it...

Resource Allocation and Time Utilization in IGE and Non-IGE Schools. Technical Paper No. 410.

ERIC Educational Resources Information Center

Rossmiller, Richard A.; Geske, Terry G.

This study addressed two basic questions; (1) Do individually guided education (IGE) schools cost more or exhibit different expenditure patterns than non-IGE schools? (2) Do instructional personnel in IGE schools allocate their time differently than instructional personnel in non-IGE schools? Data were obtained from a random sample of 41 IGE…

The Effect of IV Amino Acid Supplementation on Mortality in ICU Patients May Be Dependent on Kidney Function: Post Hoc Subgroup Analyses of a Multicenter Randomized Trial.

PubMed

Zhu, Ran; Allingstrup, Matilde J; Perner, Anders; Doig, Gordon S

2018-05-15

We investigated whether preexisting kidney function determines if ICU patients may benefit from increased (2.0 g/kg/d) protein intake. Post hoc, hypothesis-generating, subgroup analysis of a multicenter, phase 2, randomized clinical trial. All analyses were conducted by intention to treat and maintained group allocation. Ninety-day mortality was the primary outcome. ICUs of 16 hospitals throughout Australia and New Zealand. Adult critically ill patients expected to remain in the study ICU for longer than 2 days. Random allocation to receive a daily supplement of up to 100 g of IV amino acids to achieve a total protein intake of 2.0 g/kg/d or standard nutrition care. A total of 474 patients were randomized: 235 to standard care and 239 to IV amino acid supplementation. There was a statistically significant interaction between baseline kidney function and supplementation with study amino acids (p value for interaction = 0.026). Within the subgroup of patients with normal kidney function at randomization, patients who were allocated to receive the study amino acid supplement were less likely to die before study day 90 (covariate-adjusted risk difference, -7.9%; 95% CI, -15.1 to -0.7; p = 0.034). Furthermore, amino acid supplementation significantly increased estimated glomerular filtration rate in these patients (repeated-measures treatment × time interaction p = 0.009). Within the subgroup of patients with baseline kidney dysfunction and/or risk of progression of acute kidney injury, a significant effect of the study intervention on mortality was not found (covariate-adjusted risk difference, -0.6%; 95% CI, -16.2 to 15.2; p = 0.95). In this post hoc, hypothesis-generating, subgroup analysis, we observed reduced mortality and improved estimated glomerular filtration rate in ICU patients with normal kidney function who were randomly allocated to receive increased protein intake (up to 2.0 g/kg/d). We strongly recommend confirmation of these results in trials with low risk of bias before this treatment is recommended for routine care.

An intervention that reduces stress in people who combine work with informal care: randomized controlled trial results.

PubMed

Boezeman, Edwin J; Nieuwenhuijsen, Karen; Sluiter, Judith K

2018-06-01

The aim of the research was to examine whether a role-focused self-help course intervention would decrease caregiver stress and distress, and functioning problems, among people who suffer stress because they combine paid work with informal care. A pre-registered (NTR 5528) randomized controlled design was applied (intervention vs. wait list control). Participants (n = 128) were people who had paid work and were suffering stress due to their involvement in informal care activities. Participants allocated to the intervention group (n = 65) received the role-focused self-help course. Control group members (n = 63) received this intervention after all measurements. Prior to the random allocation (pre-test), and 1 month (post-test 1) and 2 months (post-test 2) after allocation, all participants completed a questionnaire that measured their caregiver stress (primary outcome), distress, work functioning, negative care-to-work interference and negative care-to-social and personal life interference. Mixed model ANOVAs were used to test the effectiveness of the intervention. Two months after allocation, the intervention group participants had lower levels of caregiver stress and distress compared with the control group participants. The intervention did not directly resolve impaired work functioning or interference of care with work and social/personal life. The intervention decreases caregiver stress and distress in people who suffer stress because they combine paid work with informal caring. The intervention (Dutch version) can be downloaded at no cost from www.amc.nl/mantelzorgstress.

A distributed scheduling algorithm for heterogeneous real-time systems

NASA Technical Reports Server (NTRS)

Zeineldine, Osman; El-Toweissy, Mohamed; Mukkamala, Ravi

1991-01-01

Much of the previous work on load balancing and scheduling in distributed environments was concerned with homogeneous systems and homogeneous loads. Several of the results indicated that random policies are as effective as other more complex load allocation policies. The effects of heterogeneity on scheduling algorithms for hard real time systems is examined. A distributed scheduler specifically to handle heterogeneities in both nodes and node traffic is proposed. The performance of the algorithm is measured in terms of the percentage of jobs discarded. While a random task allocation is very sensitive to heterogeneities, the algorithm is shown to be robust to such non-uniformities in system components and load.

Pseudo-random dynamic address configuration (PRDAC) algorithm for mobile ad hoc networks

NASA Astrophysics Data System (ADS)

Wu, Shaochuan; Tan, Xuezhi

2007-11-01

By analyzing all kinds of address configuration algorithms, this paper provides a new pseudo-random dynamic address configuration (PRDAC) algorithm for mobile ad hoc networks. Based on PRDAC, the first node that initials this network randomly chooses a nonlinear shift register that can generates an m-sequence. When another node joins this network, the initial node will act as an IP address configuration sever to compute an IP address according to this nonlinear shift register, and then allocates this address and tell the generator polynomial of this shift register to this new node. By this means, when other node joins this network, any node that has obtained an IP address can act as a server to allocate address to this new node. PRDAC can also efficiently avoid IP conflicts and deal with network partition and merge as same as prophet address (PA) allocation and dynamic configuration and distribution protocol (DCDP). Furthermore, PRDAC has less algorithm complexity, less computational complexity and more sufficient assumption than PA. In addition, PRDAC radically avoids address conflicts and maximizes the utilization rate of IP addresses. Analysis and simulation results show that PRDAC has rapid convergence, low overhead and immune from topological structures.

A multi-assets artificial stock market with zero-intelligence traders

NASA Astrophysics Data System (ADS)

Ponta, L.; Raberto, M.; Cincotti, S.

2011-01-01

In this paper, a multi-assets artificial financial market populated by zero-intelligence traders with finite financial resources is presented. The market is characterized by different types of stocks representing firms operating in different sectors of the economy. Zero-intelligence traders follow a random allocation strategy which is constrained by finite resources, past market volatility and allocation universe. Within this framework, stock price processes exhibit volatility clustering, fat-tailed distribution of returns and reversion to the mean. Moreover, the cross-correlations between returns of different stocks are studied using methods of random matrix theory. The probability distribution of eigenvalues of the cross-correlation matrix shows the presence of outliers, similar to those recently observed on real data for business sectors. It is worth noting that business sectors have been recovered in our framework without dividends as only consequence of random restrictions on the allocation universe of zero-intelligence traders. Furthermore, in the presence of dividend-paying stocks and in the case of cash inflow added to the market, the artificial stock market points out the same structural results obtained in the simulation without dividends. These results suggest a significative structural influence on statistical properties of multi-assets stock market.

Principles of scarce medical resource allocation in natural disaster relief: a simulation approach.

PubMed

Cao, Hui; Huang, Simin

2012-01-01

A variety of triage principles have been proposed. The authors sought to evaluate their effects on how many lives can be saved in a hypothetical disaster. To determine an optimal scarce resource-rationing principle in the emergency response domain, considering the trade-off between lifesaving efficiency and ethical issues. A discrete event simulation model is developed to examine the efficiency of four resource-rationing principles: first come-first served, random, most serious first, and least serious first. Seven combinations of available resources are examined in the simulations to evaluate the performance of the principles under different levels of resource scarcity. The simulation results indicate that the performance of the medical resource allocation principles is related to the level of the resource scarcity. When the level of the scarcity is high, the performances of the four principles differ significantly. The least serious first principle performs best, followed by the random principle; the most serious first principle acts worst. However, when the scarcity is relieved, there are no significant differences among the random, first come-first served, and least serious first principles, yet the most serious first principle still performs worst. Although the least serious first principle exhibits the highest efficiency, it is not ethically flawless. Considering the trade off between the lifesaving efficiency and the ethical issues, random selection is a relatively fair and efficient principle for allocating scarce medical resources in natural disaster responses.

On the Upward Bias of the Dissimilarity Index and Its Corrections

ERIC Educational Resources Information Center

Mazza, Angelo; Punzo, Antonio

2015-01-01

The dissimilarity index of Duncan and Duncan is widely used in a broad range of contexts to assess the overall extent of segregation in the allocation of two groups in two or more units. Its sensitivity to random allocation implies an upward bias with respect to the unknown amount of systematic segregation. In this article, following a multinomial…

Dynamic Quantum Allocation and Swap-Time Variability in Time-Sharing Operating Systems.

ERIC Educational Resources Information Center

Bhat, U. Narayan; Nance, Richard E.

The effects of dynamic quantum allocation and swap-time variability on central processing unit (CPU) behavior are investigated using a model that allows both quantum length and swap-time to be state-dependent random variables. Effective CPU utilization is defined to be the proportion of a CPU busy period that is devoted to program processing, i.e.…

A Cluster Randomized Controlled Trial Testing the Effectiveness of Houvast: A Strengths-Based Intervention for Homeless Young Adults

ERIC Educational Resources Information Center

Krabbenborg, Manon A. M.; Boersma, Sandra N.; van der Veld, William M.; van Hulst, Bente; Vollebergh, Wilma A. M.; Wolf, Judith R. L. M.

2017-01-01

Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended.…

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

PubMed

Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

2013-11-01

To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

Mentalization-based therapy for parents in entrenched conflict: A random allocation feasibility study.

PubMed

Hertzmann, Leezah; Target, Mary; Hewison, David; Casey, Polly; Fearon, Pasco; Lassri, Dana

2016-12-01

To explore the effectiveness of a mentalization-based therapeutic intervention specifically developed for parents in entrenched conflict over their children. To the best of our knowledge, this is the first randomized controlled intervention study in the United Kingdom to work with both parents postseparation, and the first to focus on mentalization in this situation. Using a mixed-methods study design, 30 parents were randomly allocated to either mentalization-based therapy for parental conflict-Parenting Together, or the Parents' Group, a psycho-educational intervention for separated parents based on elements of the Separated Parents Information Program-part of the U.K. Family Justice System and approximating to treatment as usual. Given the challenges of recruiting parents in these difficult circumstances, the sample size was small and permitted only the detection of large differences between conditions. The data, involving repeated measures of related individuals, was explored statistically, using hierarchical linear modeling, and qualitatively. Significant findings were reported on the main predicted outcomes, with clinically important trends on other measures. Qualitative findings further contributed to the understanding of parents' subjective experience, pre- and posttreatment. Findings indicate that a larger scale randomized controlled trial would be worthwhile. These encouraging findings shed light on the dynamics maintaining these high-conflict situations known to be damaging to children. We established that both forms of intervention were acceptable to most parents, and we were able to operate a random allocation design with extensive quantitative and qualitative assessments of the kind that would make a larger-scale trial feasible and productive. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Age-Related Changes in Temporal Allocation of Visual Attention: Evidence from the Rapid Serial Visual Presentation (RSVP) Paradigm

ERIC Educational Resources Information Center

Berger, Carole; Valdois, Sylviane; Lallier, Marie; Donnadieu, Sophie

2015-01-01

The present study explored the temporal allocation of attention in groups of 8-year-old children, 10-year-old children, and adults performing a rapid serial visual presentation task. In a dual-condition task, participants had to detect a briefly presented target (T2) after identifying an initial target (T1) embedded in a random series of…

The Quantitative Effect of Students Using Podcasts in a First Year Undergraduate Exercise Physiology Module

ERIC Educational Resources Information Center

Abt, Grant; Barry, Tim

2007-01-01

This study reports the quantitative effect of students using podcasts in a 1st year undergraduate exercise physiology module. From a cohort of 70 students, 50 volunteered and completed the study. Using a pre-post random allocation research design, students were allocated to either a podcast group (PG) or control group (CG) based on a 32-question…

Enhancements and Algorithms for Avionic Information Processing System Design Methodology.

DTIC Science & Technology

1982-06-16

programming algorithm is enhanced by incorporating task precedence constraints and hardware failures. Stochastic network methods are used to analyze...allocations in the presence of random fluctuations. Graph theoretic methods are used to analyze hardware designs, and new designs are constructed with...There, spatial dynamic programming (SDP) was used to solve a static, deterministic software allocation problem. Under the current contract the SDP

Randomised clinical trial of strategies for improving medication compliance in primary hypertension.

PubMed

Sackett, D L; Haynes, R B; Gibson, E S; Hackett, B C; Taylor, D W; Roberts, R S; Johnson, A L

1975-05-31

230 Canadian steelworkers with hypertension took part in a randomised trial to see if compliance with antihypertensive drug regimens could be improved. For care and follow-up these men were randomly allocated to see either their own family doctors outside working-hours or industrial physicians during work shifts; the same men were randomly allocated to receive or not receive an educational programme aimed at instructing them about hypertension and its treatment. Surprisingly, the convenience of follow-up at work had no effect upon these men's compliance with antihypertensive drug regimens. Similarly, although men receiving health education learned a lot about hypertension, they were not more likely to take their medicine.

Quasi-experimental study designs series-paper 1: introduction: two historical lineages.

PubMed

Bärnighausen, Till; Røttingen, John-Arne; Rockers, Peter; Shemilt, Ian; Tugwell, Peter

2017-09-01

The objective of this study was to contrast the historical development of experiments and quasi-experiments and provide the motivation for a journal series on quasi-experimental designs in health research. A short historical narrative, with concrete examples, and arguments based on an understanding of the practice of health research and evidence synthesis. Health research has played a key role in developing today's gold standard for causal inference-the randomized controlled multiply blinded trial. Historically, allocation approaches developed from convenience and purposive allocation to alternate and, finally, to random allocation. This development was motivated both by concerns for manipulation in allocation as well as statistical and theoretical developments demonstrating the power of randomization in creating counterfactuals for causal inference. In contrast to the sequential development of experiments, quasi-experiments originated at very different points in time, from very different scientific perspectives, and with frequent and long interruptions in their methodological development. Health researchers have only recently started to recognize the value of quasi-experiments for generating novel insights on causal relationships. While quasi-experiments are unlikely to replace experiments in generating the efficacy and safety evidence required for clinical guidelines and regulatory approval of medical technologies, quasi-experiments can play an important role in establishing the effectiveness of health care practice, programs, and policies. The papers in this series describe and discuss a range of important issues in utilizing quasi-experimental designs for primary research and quasi-experimental results for evidence synthesis. Copyright © 2017 Elsevier Inc. All rights reserved.

[Non-randomized evaluation studies (TREND)].

PubMed

Vallvé, Carles; Artés, Maite; Cobo, Erik

2005-12-01

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

Examining the Minimal Required Elements of a Computer-Tailored Intervention Aimed at Dietary Fat Reduction: Results of a Randomized Controlled Dismantling Study

ERIC Educational Resources Information Center

Kroeze, Willemieke; Oenema, Anke; Dagnelie, Pieter C.; Brug, Johannes

2008-01-01

This study investigated the minimally required feedback elements of a computer-tailored dietary fat reduction intervention to be effective in improving fat intake. In all 588 Healthy Dutch adults were randomly allocated to one of four conditions in an randomized controlled trial: (i) feedback on dietary fat intake [personal feedback (P feedback)],…

Random Measurement Error as a Source of Discrepancies between the Reports of Wives and Husbands Concerning Marital Power and Task Allocation.

ERIC Educational Resources Information Center

Quarm, Daisy

1981-01-01

Findings for couples (N=119) show wife's work, money, and spare time low between-spouse correlations are due in part to random measurement error. Suggests that increasing reliability of measures by creating multi-item indices can also increase correlations. Car purchase, vacation, and child discipline were not accounted for by random measurement…

A Dexterous Optional Randomized Response Model

ERIC Educational Resources Information Center

Tarray, Tanveer A.; Singh, Housila P.; Yan, Zaizai

2017-01-01

This article addresses the problem of estimating the proportion Pi[subscript S] of the population belonging to a sensitive group using optional randomized response technique in stratified sampling based on Mangat model that has proportional and Neyman allocation and larger gain in efficiency. Numerically, it is found that the suggested model is…

Dynamic fair node spectrum allocation for ad hoc networks using random matrices

NASA Astrophysics Data System (ADS)

Rahmes, Mark; Lemieux, George; Chester, Dave; Sonnenberg, Jerry

2015-05-01

Dynamic Spectrum Access (DSA) is widely seen as a solution to the problem of limited spectrum, because of its ability to adapt the operating frequency of a radio. Mobile Ad Hoc Networks (MANETs) can extend high-capacity mobile communications over large areas where fixed and tethered-mobile systems are not available. In one use case with high potential impact, cognitive radio employs spectrum sensing to facilitate the identification of allocated frequencies not currently accessed by their primary users. Primary users own the rights to radiate at a specific frequency and geographic location, while secondary users opportunistically attempt to radiate at a specific frequency when the primary user is not using it. We populate a spatial radio environment map (REM) database with known information that can be leveraged in an ad hoc network to facilitate fair path use of the DSA-discovered links. Utilization of high-resolution geospatial data layers in RF propagation analysis is directly applicable. Random matrix theory (RMT) is useful in simulating network layer usage in nodes by a Wishart adjacency matrix. We use the Dijkstra algorithm for discovering ad hoc network node connection patterns. We present a method for analysts to dynamically allocate node-node path and link resources using fair division. User allocation of limited resources as a function of time must be dynamic and based on system fairness policies. The context of fair means that first available request for an asset is not envied as long as it is not yet allocated or tasked in order to prevent cycling of the system. This solution may also save money by offering a Pareto efficient repeatable process. We use a water fill queue algorithm to include Shapley value marginal contributions for allocation.

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

PubMed

Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

2015-02-08

Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis. This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

Is Reducing Uncertain Control the Key to Successful Test Anxiety Intervention for Secondary School Students? Findings from a Randomized Control Trial

ERIC Educational Resources Information Center

Putwain, David W.; Pescod, Marc

2018-01-01

The aim of the study was to conduct a randomized control trial of a targeted, facilitated, test anxiety intervention for a group of adolescent students, and to examine the mediating role of uncertain control. Fifty-six participants (male = 19, white = 21, mean age = 14.7 years) were randomly allocated to an early intervention or wait-list control…

A Randomized Controlled Trial of Exposure Therapy and Cognitive Restructuring for Posttraumatic Stress Disorder

ERIC Educational Resources Information Center

Bryant, Richard A.; Moulds, Michelle L.; Guthrie, Rachel M.; Dang, Suzanne T.; Mastrodomenico, Julie; Nixon, Reginald D. V.; Felmingham, Kim L.; Hopwood, Sally; Creamer, Mark

2008-01-01

Previous studies have reported that adding cognitive restructuring (CR) to exposure therapy does not enhance treatment gains in posttraumatic stress disorder (PTSD). This study investigated the extent to which CR would augment treatment response when provided with exposure therapy. The authors randomly allocated 118 civilian trauma survivors with…

Behavioral Family Intervention for Children with Developmental Disabilities and Behavioral Problems

ERIC Educational Resources Information Center

Roberts, Clare; Mazzucchelli, Trevor; Studman, Lisa; Sanders, Matthew R.

2006-01-01

The outcomes of a randomized clinical trial of a new behavioral family intervention, Stepping Stones Triple P, for preschoolers with developmental and behavior problems are presented. Forty-eight children with developmental disabilities participated, 27 randomly allocated to an intervention group and 20 to a wait-list control group. Parents…

Menstruation and Education in Nepal. NBER Working Paper No. 14853

ERIC Educational Resources Information Center

Oster, Emily; Thornton, Rebecca

2009-01-01

This paper presents the results from a randomized evaluation that distributed menstrual cups (menstrual sanitary products) to adolescent girls in rural Nepal. Girls in the study were randomly allocated a menstrual cup for use during their monthly period and were followed for fifteen months to measure the effects of having modern sanitary products…

Telephone-Based Coping Skills Training for Patients Awaiting Lung Transplantation

ERIC Educational Resources Information Center

Blumenthal, James A.; Babyak, Michael A.; Keefe, Francis J.; Davis, R. Duane; LaCaille, Rick A.; Carney, Robert M.; Freedland, Kenneth E.; Trulock, Elbert; Palmer, Scott M.

2006-01-01

Impaired quality of life is associated with increased mortality in patients with advanced lung disease. Using a randomized controlled trial with allocation concealment and blinded outcome assessment at 2 tertiary care teaching hospitals, the authors randomly assigned 328 patients with end-stage lung disease awaiting lung transplantation to 12…

Individual mineral supplement intake by ewes swath grazing or confinement fed pea-barley forage

USDA-ARS?s Scientific Manuscript database

Sixty mature ewes (non-pregnant, non-lactating) were used in a completely randomized design to determine if feeding method of pea-barley forage (swath grazing or hay in confinement) had an effect on individual ewe mineral consumption. Thirty ewes were randomly allocated to 3 confinement pens and 30 ...

Promoting Protective Factors for Young Adolescents: ABCD Parenting Young Adolescents Program Randomized Controlled Trial

ERIC Educational Resources Information Center

Burke, Kylie; Brennan, Leah; Cann, Warren

2012-01-01

This study examined the efficacy of a program for parents of young adolescents combining behavioral family intervention with acceptance-based strategies. 180 parents were randomly allocated to a 6-session group ABCD Parenting Young Adolescent Program or wait-list condition. Completer analysis indicated parents in the intervention reported…

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

ERIC Educational Resources Information Center

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

2013-01-01

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

As-built design specification for proportion estimate software subsystem

NASA Technical Reports Server (NTRS)

Obrien, S. (Principal Investigator)

1980-01-01

The Proportion Estimate Processor evaluates four estimation techniques in order to get an improved estimate of the proportion of a scene that is planted in a selected crop. The four techniques to be evaluated were provided by the techniques development section and are: (1) random sampling; (2) proportional allocation, relative count estimate; (3) proportional allocation, Bayesian estimate; and (4) sequential Bayesian allocation. The user is given two options for computation of the estimated mean square error. These are referred to as the cluster calculation option and the segment calculation option. The software for the Proportion Estimate Processor is operational on the IBM 3031 computer.

Long-term outcomes in women with polycystic ovary syndrome initially randomized to receive laparoscopic electrocautery of the ovaries or ovulation induction with gonadotrophins.

PubMed

Nahuis, M J; Kose, N; Bayram, N; van Dessel, H J H M; Braat, D D M; Hamilton, C J C M; Hompes, P G A; Bossuyt, P M; Mol, B W J; van der Veen, F; van Wely, M

2011-07-01

Long-term effects of laparoscopic electrocautery of the ovaries are unknown. To study the long-term effects of laparoscopic electrocautery of the ovaries and gonadotrophins, we followed women with clomiphene-resistant polycystic ovary syndrome (PCOS) randomly allocated to one of these treatments until 8-12 years after their initial treatment. Between February 1998 and October 2001 168 women with clomiphene citrate-resistant PCOS were included in a randomized controlled trial comparing an electrocautery strategy to a strategy starting with rFSH. In 2009 these women were contacted about their reproductive outcome and menstrual cycle regularity. Analysis was by intention-to-treat. We compared time to conception resulting in live birth, subsequent pregnancies, ectopic and multiple pregnancies, menopause, as well as minimal and maximal menstrual cycle length. After 8-12 years, the cumulative proportion of women with a first child was 86% in women who had been allocated to electrocautery versus 81% in women who had been allocated to immediate rFSH [relative ratio (RR): 1.1; 95% confidence interval (CI): 0.92-1.2]. Treatment with electrocautery resulted in a significantly lower need for stimulated cycles to reach a live birth; 53% after electrocautery versus 76% after rFSH (RR: 0.69; 95% CI: 0.55-0.88).The cumulative proportion of women with a second child was 61% after electrocautery versus 46% after immediate rFSH (RR: 1.4; 95% CI: 1.00-1.9). Overall, there were 7 twins out of 134 deliveries (5%) after electrocautery versus 10 twins out of 124 deliveries (8%) in the rFSH group (RR: 0.65; 95% CI: 0.25-1.6). Fifty-four per cent of the women allocated to electrocautery had a regular menstrual cycle 8-12 years after randomization versus 36% in those allocated to rFSH (RR: 1.5; 95% CI: 0.87-2.6). In women with clomiphene-resistant PCOS, laparoscopic electrocautery of the ovaries is as effective as ovulation induction with FSH treatment in terms of live births, but reduces the need for ovulation induction or ART in a significantly higher proportion of women and increases the chance for a second child. Clinicians may use these data when informing clomiphene-resistant anovulatory women about treatment options.

OxMaR: open source free software for online minimization and randomization for clinical trials.

PubMed

O'Callaghan, Christopher A

2014-01-01

Minimization is a valuable method for allocating participants between the control and experimental arms of clinical studies. The use of minimization reduces differences that might arise by chance between the study arms in the distribution of patient characteristics such as gender, ethnicity and age. However, unlike randomization, minimization requires real time assessment of each new participant with respect to the preceding distribution of relevant participant characteristics within the different arms of the study. For multi-site studies, this necessitates centralized computational analysis that is shared between all study locations. Unfortunately, there is no suitable freely available open source or free software that can be used for this purpose. OxMaR was developed to enable researchers in any location to use minimization for patient allocation and to access the minimization algorithm using any device that can connect to the internet such as a desktop computer, tablet or mobile phone. The software is complete in itself and requires no special packages or libraries to be installed. It is simple to set up and run over the internet using online facilities which are very low cost or even free to the user. Importantly, it provides real time information on allocation to the study lead or administrator and generates real time distributed backups with each allocation. OxMaR can readily be modified and customised and can also be used for standard randomization. It has been extensively tested and has been used successfully in a low budget multi-centre study. Hitherto, the logistical difficulties involved in minimization have precluded its use in many small studies and this software should allow more widespread use of minimization which should lead to studies with better matched control and experimental arms. OxMaR should be particularly valuable in low resource settings.

Effect of Reassuring Information About Musculoskeletal and Mental Health Complaints at the Workplace: A Cluster Randomized Trial of the atWork Intervention.

PubMed

Johnsen, Tone Langjordet; Eriksen, Hege Randi; Baste, Valborg; Indahl, Aage; Odeen, Magnus; Tveito, Torill Helene

2018-05-21

Purpose The purpose of this study was to investigate the possible difference between the Modified atWork intervention (MAW) and the Original atWork intervention (OAW) on sick leave and other health related outcomes. atWork is a group intervention using the workplace as an arena for distribution of evidence-based knowledge about musculoskeletal and mental health complaints. Methods A cluster randomized controlled trial with 93 kindergartens, comprising a total of 1011 employees, was conducted. Kindergartens were stratified by county and size and randomly allocated to MAW (45 clusters, 324 respondents) or OAW (48 clusters, 313 respondents). The randomization and intervention allocation processes were concealed. There was no blinding to group allocation. Primary outcome was register data on sick leave at cluster level. Secondary outcomes were health complaints, job satisfaction, social support, coping, and beliefs about musculoskeletal and mental health complaints, measured at the individual level. Results The MAW group reduced sick leave by 5.7% during the intervention year, while the OAW group had a 7.5% increase. Overall, the changes were not statistically significant, and no difference was detected between groups, based on 45 and 47 kindergartens. Compared to the OAW group, the MAW group had a smaller reduction for two of the statements concerning faulty beliefs about back pain, but believed less in the hereditary nature of depression. Conclusions The MAW did not have a different effect on sick leave at cluster level compared to the OAW. Trial registration https://Clinicaltrials.gov/ : NCT02396797. Registered March 23th, 2015.

National survey of physicians to determine the effect of unconditional incentives on response rates of physician postal surveys

PubMed Central

Abdulaziz, Kasim; Brehaut, Jamie; Taljaard, Monica; Émond, Marcel; Sirois, Marie-Josée; Lee, Jacques S; Wilding, Laura; Perry, Jeffrey J

2015-01-01

Objectives Physicians are a commonly targeted group in health research surveys, but their response rates are often relatively low. The goal of this paper was to evaluate the effect of unconditional incentives in the form of a coffee card on physician postal survey response rates. Design Following 13 key informant interviews and eight cognitive interviews a survey questionnaire was developed. Participants A random sample of 534 physicians, stratified by physician group (geriatricians, family physicians, emergency physicians) was selected from a national medical directory. Setting Using computer generated random numbers; half of the physicians in each stratum were allocated to receive a coffee card to a popular national coffee chain together with the first survey mailout. Interventions The intervention was a $10 Tim Hortons gift card given to half of the physicians who were randomly allocated to receive the incentive. Results 265 (57.0%) physicians completed the survey. The response rate was significantly higher in the group allocated to receive the incentive (62.7% vs 51.3% in the control group; p=0.01). Conclusions Our results indicate that an unconditional incentive in the form of a coffee gift card can substantially improve physician response rates. Future research can look at the effect of varying amounts of cash on the gift cards on response rates. PMID:25694460

Efficient Graph-Based Resource Allocation Scheme Using Maximal Independent Set for Randomly- Deployed Small Star Networks

PubMed Central

Zhou, Jian; Wang, Lusheng; Wang, Weidong; Zhou, Qingfeng

2017-01-01

In future scenarios of heterogeneous and dense networks, randomly-deployed small star networks (SSNs) become a key paradigm, whose system performance is restricted to inter-SSN interference and requires an efficient resource allocation scheme for interference coordination. Traditional resource allocation schemes do not specifically focus on this paradigm and are usually too time consuming in dense networks. In this article, a very efficient graph-based scheme is proposed, which applies the maximal independent set (MIS) concept in graph theory to help divide SSNs into almost interference-free groups. We first construct an interference graph for the system based on a derived distance threshold indicating for any pair of SSNs whether there is intolerable inter-SSN interference or not. Then, SSNs are divided into MISs, and the same resource can be repetitively used by all the SSNs in each MIS. Empirical parameters and equations are set in the scheme to guarantee high performance. Finally, extensive scenarios both dense and nondense are randomly generated and simulated to demonstrate the performance of our scheme, indicating that it outperforms the classical max K-cut-based scheme in terms of system capacity, utility and especially time cost. Its achieved system capacity, utility and fairness can be close to the near-optimal strategy obtained by a time-consuming simulated annealing search. PMID:29113109

Mentalization-Based Treatment for Self-Harm in Adolescents: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Rossouw, Trudie I.; Fonagy, Peter

2012-01-01

Objective: We examined whether mentalization-based treatment for adolescents (MBT-A) is more effective than treatment as usual (TAU) for adolescents who self-harm. Method: A total of 80 adolescents (85% female) consecutively presenting to mental health services with self-harm and comorbid depression were randomly allocated to either MBT-A or TAU.…

Bibliotherapy for Children with Anxiety Disorders Using Written Materials for Parents: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Rapee, Ronald M.; Abbott, Maree J.; Lyneham, Heidi J.

2006-01-01

The current trial examined the value of modifying empirically validated treatment for childhood anxiety for application via written materials for parents of anxious children. Two hundred sixty-seven clinically anxious children ages 6-12 years and their parents were randomly allocated to standard group treatment, wait list, or a bibliotherapy…

Gender Differences in the Maintenance of Response to Cognitive Behavior Therapy for Posttraumatic Stress Disorder

ERIC Educational Resources Information Center

Felmingham, Kim L.; Bryant, Richard A.

2012-01-01

Objective: To examine potential differential responses in men and women to cognitive behavior therapy for posttraumatic stress disorder (PTSD). Method: Fifty-two men and 56 women diagnosed with PTSD participated in randomized controlled trials of cognitive behavior therapy for PTSD. Participants were randomly allocated to either (a) exposure-only…

The Oregon health insurance experiment: when limited policy resources provide research opportunities.

PubMed

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

2013-12-01

In 2008 Oregon allocated access to its Medicaid expansion program, Oregon Health Plan Standard, by drawing names from a waiting list by lottery. The lottery was chosen by policy makers and stakeholders as the preferred way to allocate limited resources. At the same time, it also gave rise to the Oregon Health Insurance Experiment: an unprecedented opportunity to do a randomized evaluation - the gold standard in medical and scientific research - of the impact of expanding Medicaid. In this article we provide historical context for Oregon's decision to conduct a lottery, discuss the importance of randomized controlled designs for policy evaluation, and describe some of the practical challenges in successfully capitalizing on the research opportunity presented by the Oregon lottery through public-academic partnerships. Since policy makers will always face tough choices about how to distribute scarce resources, we urge thoughtful consideration of the opportunities to incorporate randomization that can substantially improve the evidence available to inform policy decisions without compromising policy goals.

Interrelation Between Safety Factors and Reliability

NASA Technical Reports Server (NTRS)

Elishakoff, Isaac; Chamis, Christos C. (Technical Monitor)

2001-01-01

An evaluation was performed to establish relationships between safety factors and reliability relationships. Results obtained show that the use of the safety factor is not contradictory to the employment of the probabilistic methods. In many cases the safety factors can be directly expressed by the required reliability levels. However, there is a major difference that must be emphasized: whereas the safety factors are allocated in an ad hoc manner, the probabilistic approach offers a unified mathematical framework. The establishment of the interrelation between the concepts opens an avenue to specify safety factors based on reliability. In cases where there are several forms of failure, then the allocation of safety factors should he based on having the same reliability associated with each failure mode. This immediately suggests that by the probabilistic methods the existing over-design or under-design can be eliminated. The report includes three parts: Part 1-Random Actual Stress and Deterministic Yield Stress; Part 2-Deterministic Actual Stress and Random Yield Stress; Part 3-Both Actual Stress and Yield Stress Are Random.

Can self-care health books affect amount of contact with the primary health care team? A randomized controlled trial in general practice.

PubMed

Platts, Amanda; Mitton, Rosly; Boniface, David; Friedli, Karin

2005-09-01

To investigate the effects of two differently styled self-care health books in general practice on the frequency and duration of patients' consultations and their views of the books. Random allocation of patients to either a descriptive or a decision-tree based self-care health book, or a no-book control condition. Three- and 12-months follow-up by postal questionnaire and monitoring of consultations. A large general practice in the South East of England. A total of 1967 volunteer, adult patients who attended the practice in 2001 participated. Demographics; health problems; use of health services; use and perceptions of the trial book; frequency and duration of consultations. Response rates to postal questionnaires at 3 and 12 months were 80% and 74%. In all, 48% consulted their allocated book, compared with 25% who consulted any healthcare book in the Control group. Those reporting health problems were more likely to have consulted their allocated book; 60% reported that the allocated book made them more likely to deal with a problem themselves and 40% reported themselves less likely to consult the practice. However, there were no differences in consultation rates or durations of consultations between the three groups. Handing out of self-care health books may provide qualitative benefits for patients but is unlikely to reduce attendance at the GP practice.

An exploratory study on equity in funding allocation for essential medicines and health supplies in Uganda's public sector.

PubMed

Kusemererwa, Donna; Alban, Anita; Obua, Ocwa Thomas; Trap, Birna

2016-08-30

To ascertain equity in financing for essential medicines and health supplies (EMHS) in Uganda, this paper explores the relationships among government funding allocations for EMHS, patient load, and medicines availability across facilities at different levels of care. We collected data on EMHS allocations and availability of selected vital medicines from 43 purposively sampled hospitals and the highest level health centers (HC IV), 44 randomly selected lower-level health facilities (HC II, III), and from over 400 facility health information system records and National Medical Stores records. The data were analyzed to determine allocations per patient within and across levels of care and the effects of allocations on product availability. EMHS funding allocations per patient varied widely within facilities at the same level, and allocations per patient between levels overlapped considerably. For example, HC IV allocations per patient ranged from US$0.25 to US$2.14 (1:9 ratio of lowest to highest allocation), and over 75 % of HC IV facilities had the same or lower average allocation per patient than HC III facilities. Overall, 43 % of all the facilities had optimal stock levels, 27 % were understocked, and 30 % were overstocked. Using simulations, we reduced the ratio between the highest and lowest allocations per patient within a level of care to less than two and eliminated the overlap in allocation per patient between levels. Inequity in EMHS allocation is demonstrated by the wide range of funding allocations per patient and the corresponding disparities in medicines availability. We show that using patient load to calculate EMHS allocations has the potential to improve equity significantly. However, more research in this area is urgently needed. The article does not report any results of human participants. It is implemented in collaboration with the Uganda's Ministry of Health, Pharmacy Division.

The statistical pitfalls of the partially randomized preference design in non-blinded trials of psychological interventions.

PubMed

Gemmell, Isla; Dunn, Graham

2011-03-01

In a partially randomized preference trial (PRPT) patients with no treatment preference are allocated to groups at random, but those who express a preference receive the treatment of their choice. It has been suggested that the design can improve the external and internal validity of trials. We used computer simulation to illustrate the impact that an unmeasured confounder could have on the results and conclusions drawn from a PRPT. We generated 4000 observations ("patients") that reflected the distribution of the Beck Depression Index (DBI) in trials of depression. Half were randomly assigned to a randomized controlled trial (RCT) design and half were assigned to a PRPT design. In the RCT, "patients" were evenly split between treatment and control groups; whereas in the preference arm, to reflect patient choice, 87.5% of patients were allocated to the experimental treatment and 12.5% to the control. Unadjusted analyses of the PRPT data consistently overestimated the treatment effect and its standard error. This lead to Type I errors when the true treatment effect was small and Type II errors when the confounder effect was large. The PRPT design is not recommended as a method of establishing an unbiased estimate of treatment effect due to the potential influence of unmeasured confounders. Copyright © 2011 John Wiley & Sons, Ltd.

Mindfulness-Based Cognitive Therapy for Individuals Whose Lives Have Been Affected by Cancer: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Foley, Elizabeth; Baillie, Andrew; Huxter, Malcolm; Price, Melanie; Sinclair, Emma

2010-01-01

Objective: This study evaluated the effectiveness of mindfulness-based cognitive therapy (MBCT) for individuals with a diagnosis of cancer. Method: Participants (N = 115) diagnosed with cancer, across site and stage, were randomly allocated to either the treatment or the wait-list condition. Treatment was conducted at 1 site, by a single…

Personality-Targeted Interventions Delay Uptake of Drinking and Decrease Risk of Alcohol-Related Problems when Delivered by Teachers

ERIC Educational Resources Information Center

O'Leary-Barrett, Maeve; Mackie, Clare J.; Castellanos-Ryan, Natalie; Al-Khudhairy, Nadia; Conrod, Patricia J.

2010-01-01

Objective: This trial examined the efficacy of teacher-delivered personality-targeted interventions for alcohol-misuse over a 6-month period. Method: This randomized controlled trial randomly allocated participating schools to intervention (n = 11) or control (n = 7) conditions. A total of 2,506 (mean age, 13.7 years) were assessed for elevated…

The Acute Effect of Methylphenidate in Brazilian Male Children and Adolescents with ADHD: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Szobot, C. M.; Ketzer, C.; Parente, M. A.; Biederman, J.; Rohde, L. A.

2004-01-01

Objective: To evaluate the acute efficacy of methylphenidate (MPH) in Brazilian male children and adolescents with ADHD. Method: In a 4-day, double-blind, placebo-controlled, randomized, fix dose escalating, parallel-group trial, 36 ADHD children and adolescents were allocated to two groups: MPH (n = 19) and placebo (n = 17). Participants were…

Mum, why do you keep on growing? Impacts of environmental variability on optimal growth and reproduction allocation strategies of annual plants.

PubMed

De Lara, Michel

2006-05-01

In their 1990 paper Optimal reproductive efforts and the timing of reproduction of annual plants in randomly varying environments, Amir and Cohen considered stochastic environments consisting of i.i.d. sequences in an optimal allocation discrete-time model. We suppose here that the sequence of environmental factors is more generally described by a Markov chain. Moreover, we discuss the connection between the time interval of the discrete-time dynamic model and the ability of the plant to rebuild completely its vegetative body (from reserves). We formulate a stochastic optimization problem covering the so-called linear and logarithmic fitness (corresponding to variation within and between years), which yields optimal strategies. For "linear maximizers'', we analyse how optimal strategies depend upon the environmental variability type: constant, random stationary, random i.i.d., random monotonous. We provide general patterns in terms of targets and thresholds, including both determinate and indeterminate growth. We also provide a partial result on the comparison between ;"linear maximizers'' and "log maximizers''. Numerical simulations are provided, allowing to give a hint at the effect of different mathematical assumptions.

Antibiotic treatment to prevent postextraction complications: a monocentric, randomized clinical trial. Preliminary outcomes.

PubMed

Barone, Antonio; Marchionni, Francesco S; Cinquini, Chiara; Cipolli Panattoni, Andrea; Toti, Paolo; Marconcini, Simone; Covani, Ugo; Gabriele, Mario

2017-08-01

Tooth extraction is a very common procedure in oral surgery. Despite this, very little information is available in the literature as to the antibiotic management of the patient. The aim of this study is to evaluate whether the antibiotic prophylaxis could be beneficial in preventing postextraction local complications and whether the use of a probiotic could help reduce the antibiotic gastro-intestinal side effects. One hundred eleven patients meeting the inclusion criteria were initially included in this randomized clinical trial and randomly allocated to one of the three experimental groups according to a computer-generated randomization list. Patients allocated to the group 1 were given amoxicillin+clavulanic acid (2 g/day for 6 days), patients allocated to the group 2 received antibiotic + probiotic (Bifidobacterium longum+lactoferrin) and patients allocated to the group 3 received no antibiotic therapy after the extraction. To evaluate post-extractive complications, controls were performed at days 7, 14 and 21 after the extraction. At T1 pain at the surgical site was present in the 48%, 30% and 71.4% of the patients belonging respectively to the antibiotic alone group, to the antibiotic+probiotic group and to the control group. The mean Numeric Rating Score (NRS) score was 1.56±1.91, 1.08±1.93, 2.02±2.27 respectively (P=0.0498). Two patients belonging to the control group experienced dry socket. In addition, 9 patients (33.3%) in the antibiotic-alone group and 1 patient (2.7%) in the antibiotic+probiotic group reported intestinal distension (P=0.0012), 7 days after surgery. Finally, diarrhea was recorded in 5 patients of the antibiotic alone group (18.5%), on the other hand, no patients of the antibiotic+probiotic group and the control group reported diarrhea. Postextractive complications observed in each group have been mild and fast to resolve. The antibiotic administration showed a decrease in pain suffered by patients but a higher incidence of gastrointestinal side effects, such as abdominal distension and diarrhea, which seemed to be relieved by the concomitant use of the probiotic.

HPS2-THRIVE randomized placebo-controlled trial in 25 673 high-risk patients of ER niacin/laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment.

PubMed

2013-05-01

Niacin has potentially favourable effects on lipids, but its effect on cardiovascular outcomes is uncertain. HPS2-THRIVE is a large randomized trial assessing the effects of extended release (ER) niacin in patients at high risk of vascular events. Prior to randomization, 42 424 patients with occlusive arterial disease were given simvastatin 40 mg plus, if required, ezetimibe 10 mg daily to standardize their low-density lipoprotein (LDL)-lowering therapy. The ability to remain compliant with ER niacin 2 g plus laropiprant 40 mg daily (ERN/LRPT) for ~1 month was then assessed in 38 369 patients and about one-third were excluded (mainly due to niacin side effects). A total of 25 673 patients were randomized between ERN/LRPT daily vs. placebo and were followed for a median of 3.9 years. By the end of the study, 25% of participants allocated ERN/LRPT vs. 17% allocated placebo had stopped their study treatment. The most common medical reasons for stopping ERN/LRPT were related to skin, gastrointestinal, diabetes, and musculoskeletal side effects. When added to statin-based LDL-lowering therapy, allocation to ERN/LRPT increased the risk of definite myopathy [75 (0.16%/year) vs. 17 (0.04%/year): risk ratio 4.4; 95% CI 2.6-7.5; P < 0.0001]; 7 vs. 5 were rhabdomyolysis. Any myopathy (definite or incipient) was more common among participants in China [138 (0.66%/year) vs. 27 (0.13%/year)] than among those in Europe [17 (0.07%/year) vs. 11 (0.04%/year)]. Consecutive alanine transaminase >3× upper limit of normal, in the absence of muscle damage, was seen in 48 (0.10%/year) ERN/LRPT vs. 30 (0.06%/year) placebo allocated participants. The risk of myopathy was increased by adding ERN/LRPT to simvastatin 40 mg daily (with or without ezetimibe), particularly in Chinese patients whose myopathy rates on simvastatin were higher. Despite the side effects of ERN/LRPT, among individuals who were able to tolerate it for ~1 month, three-quarters continued to take it for ~4 years.

Pregnancy complications and metabolic disease in women with clomiphene citrate-resistant anovulation randomized to receive laparoscopic electrocautery of the ovaries or ovulation induction with gonadotropins: a 10-year follow-up.

PubMed

Nahuis, Marleen J; Oude Lohuis, Eefje J; Bayram, Neriman; Hompes, Peter G A; Oosterhuis, G Jurjen E; van der Veen, Fulco; Mol, Ben Willem J; van Wely, Madelon

2014-01-01

To assess long-term effects of laparoscopic electrocautery of the ovaries compared with ovulation induction with gonadotropins in women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS) on the incidence of pregnancy complications like gestational diabetes, hypertensive disorders, and metabolic or cardiovascular disease. Long-term follow-up study. Twenty-eight hospitals within the Netherlands. One hundred sixty-eight CC-resistant women who had participated in a randomized controlled trial between 1998 and 2001 comparing electrocautery and gonadotropins. Postal questionnaire, search in medical files. Pregnancy complications, metabolic or cardiovascular disease. Eighty-two percent of follow-up data were obtained. Thirteen of 68 women (19%) allocated to electrocautery, and 14 of 63 women (22%) allocated to gonadotropins had evidence for pregnancy complications (relative risk 0.86; 95% confidence interval 0.43-1.7). At follow-up, 12 of 69 (17%) women allocated to electrocautery, and 13 of 69 (19%) women allocated to gonadotropins had evidence for metabolic or cardiovascular disease (relative risk 0.90; 95% confidence interval 0.39-2.1). The risk of these was modified by body mass index (BMI), but not by female age or treatment allocation. This study is based on questionnaires and data from medical files. In the absence of routine screening, under-reporting in our follow-up study is likely. Electrocautery in women with CC-resistant PCOS does not affect pregnancy complications or metabolic or cardiovascular disease later in life compared with ovulation induction with gonadotropins. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Comparison of in-vivo failure of single-thread and dual-thread temporary anchorage devices over 18 months: A split-mouth randomized controlled trial.

PubMed

Durrani, Owais Khalid; Shaheed, Sohrab; Khan, Arsalan; Bashir, Ulfat

2017-10-01

The purpose of this study was to compare the in-vivo failure rates of single-thread and dual-thread temporary anchorage device (TAD) designs over 18 months. Thirty patients with skeletal Class II Division 1 malocclusion requiring anchorage from TADs for retraction of maxillary incisors into the extracted premolar space were recruited in this parallel group, split-mouth, randomized controlled trial. A block randomization sequence was generated with Random Allocation Software (version 2.0; Isfahan, Iran) with the allocations concealed in sequentially numbered, opaque, sealed envelopes. A total of 60 TADs (diameter, 2 mm; length, 10 mm) were placed in the maxillary arches of these patients with random allocation of the 2 types to the left and the right sides in a 1:1 ratio. All TADs were placed between the roots of the second premolar and the first molar and were immediately loaded. Patients were followed for a minimum of 12 months and a maximum of 18 months for the failure of the TADs. Data were analyzed blindly on an intention-to-treat basis. Four TADs (13.3%) failed in the single-thread group, and 6 TADs (20%) failed in the dual-thread group. The McNemar test showed an insignificant difference (P = 0.72) between the 2 groups. An odds ratio of 1.6 (95% confidence interval, 0.39-6.97) showed no significant associations among the variables. Most TADs failed in the first month after insertion (50%). The failure rate of dual-thread TADs compared with single-thread TADs is statistically insignificant when placed in the maxilla for retraction of the anterior segment. Registration: The trial was not registered before commencement. The protocol was not published before the trial. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

National survey of physicians to determine the effect of unconditional incentives on response rates of physician postal surveys.

PubMed

Abdulaziz, Kasim; Brehaut, Jamie; Taljaard, Monica; Émond, Marcel; Sirois, Marie-Josée; Lee, Jacques S; Wilding, Laura; Perry, Jeffrey J

2015-02-18

Physicians are a commonly targeted group in health research surveys, but their response rates are often relatively low. The goal of this paper was to evaluate the effect of unconditional incentives in the form of a coffee card on physician postal survey response rates. Following 13 key informant interviews and eight cognitive interviews a survey questionnaire was developed. A random sample of 534 physicians, stratified by physician group (geriatricians, family physicians, emergency physicians) was selected from a national medical directory. Using computer generated random numbers; half of the physicians in each stratum were allocated to receive a coffee card to a popular national coffee chain together with the first survey mailout. The intervention was a $10 Tim Hortons gift card given to half of the physicians who were randomly allocated to receive the incentive. 265 (57.0%) physicians completed the survey. The response rate was significantly higher in the group allocated to receive the incentive (62.7% vs 51.3% in the control group; p=0.01). Our results indicate that an unconditional incentive in the form of a coffee gift card can substantially improve physician response rates. Future research can look at the effect of varying amounts of cash on the gift cards on response rates. 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.

Evaluating the importance of sham controlled trials in the investigation of medical devices in interventional cardiology.

PubMed

Byrne, Robert A; Capodanno, Davide; Mahfoud, Felix; Fajadet, Jean; Windecker, Stephan; Jüni, Peter; Baumbach, Andreas; Wijns, William; Haude, Michael

2018-05-22

Cardiovascular medicine is one of the specialties that has relied most heavily on evidence from randomized clinical trials in determining best practice for the management of common disease conditions. When comparing treatment approaches, trials incorporating random allocation are the most appropriate method for protecting against treatment allocation bias. In order to protect against performance and ascertainment bias, trial designs including placebo control are preferable where feasible. In contrast to testing of medicines, treatments based on procedures or use of medical devices are more challenging to assess, as sham procedures are necessary to facilitate blinding of participants. However, in many cases, ethical concerns exist, as individual patients allocated to sham procedure are exposed only to risk without potential for benefit. Accordingly, the potential benefits to the general patient population must be carefully weighed against the risks of the exposed individuals. For this reason, trial design and study conduct are critically important to ensure that the investigation has the best chance of answering the study question at hand. In the current manuscript, we aim to review issues relating to the conduct of sham-controlled trials and discuss a number of recent examples in the field of interventional cardiology.

Research on memory management in embedded systems

NASA Astrophysics Data System (ADS)

Huang, Xian-ying; Yang, Wu

2005-12-01

Memory is a scarce resource in embedded system due to cost and size. Thus, applications in embedded systems cannot use memory randomly, such as in desktop applications. However, data and code must be stored into memory for running. The purpose of this paper is to save memory in developing embedded applications and guarantee running under limited memory conditions. Embedded systems often have small memory and are required to run a long time. Thus, a purpose of this study is to construct an allocator that can allocate memory effectively and bear a long-time running situation, reduce memory fragmentation and memory exhaustion. Memory fragmentation and exhaustion are related to the algorithm memory allocated. Static memory allocation cannot produce fragmentation. In this paper it is attempted to find an effective allocation algorithm dynamically, which can reduce memory fragmentation. Data is the critical part that ensures an application can run regularly, which takes up a large amount of memory. The amount of data that can be stored in the same size of memory is relevant with the selected data structure. Skills for designing application data in mobile phone are explained and discussed also.

When They Call, Will They Come? A Contextually Responsive Approach for Engaging Multistressed Families in an Urban Child Mental Health Center: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Stern, Susan B.; Walsh, Margaret; Mercado, Micaela; Levene, Kathryn; Pepler, Debra J.; Carr, Ashley; Heppell, Allison; Lowe, Erin

2015-01-01

Objective: This study examines the effect of an ecological and contextually responsive approach, during initial intake call, on engagement for multistressed families seeking child mental health services in an urban setting. Methods: Using a randomized design, parents were allocated to phone Intake As Usual (IAU) or Enhanced Engagement Phone Intake…

Effects of a Cognitive Behavioral Self-Help Program on Emotional Problems for People with Acquired Hearing Loss: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Garnefski, Nadia; Kraaij, Vivian

2012-01-01

The aim of the study was to examine whether a cognitive-behavioral self-help program was effective in improving depressed mood and anxiety in people with acquired deafness. Participants were 45 persons with acquired deafness, randomly allocated to the Cognitive-Behavioral Self-help (CBS) group or the Waiting List Control (WLC) group. Depression…

Methodological Reporting Quality of Randomized Controlled Trials in 3 Leading Diabetes Journals From 2011 to 2013 Following CONSORT Statement: A System Review.

PubMed

Zhai, Xiao; Wang, Yiran; Mu, Qingchun; Chen, Xiao; Huang, Qin; Wang, Qijin; Li, Ming

2015-07-01

To appraise the current reporting methodological quality of randomized clinical trials (RCTs) in 3 leading diabetes journals.We systematically searched the literature for RCTs in Diabetes Care, Diabetes and Diabetologia from 2011 to 2013.Characteristics were extracted based on Consolidated Standards of Reporting Trials (CONSORT) statement. Generation of allocation, concealment of allocation, intention-to-treat (ITT) analysis and handling of dropouts were defined as primary outcome and "low risk of bias." Sample size calculation, type of intervention, country, number of patients, funding source were also revealed and descriptively reported. Trials were compared among journals, study years, and other characters.A total of 305 RCTs were enrolled in this study. One hundred eight (35.4%) trials reported adequate generation of allocation, 87 (28.5%) trials reported adequate concealment of allocation, 53 (23.8%) trials used ITT analysis, and 130 (58.3%) trials were adequate in handling of dropouts. Only 15 (4.9%) were "low risk of bias" trials. Studies at a large scale (n > 100) or from European presented with more "low risk of bias" trials than those at a small scale (n ≤ 100) or from other regions. No improvements were found in these 3 years.This study shows that methodological reporting quality of RCTs in the major diabetes journals remains suboptimal. It can be further improved to meet and keep up with the standards of the CONSORT statement.

Sperm competition games: sperm selection by females.

PubMed

Ball, M A; Parker, G A

2003-09-07

We analyse a co-evolutionary sexual conflict game, in which males compete for fertilizations (sperm competition) and females operate sperm selection against unfavourable ejaculates (cryptic female choice). For simplicity, each female mates with two males per reproductive event, and the competing ejaculates are of two types, favourable (having high viability or success) or unfavourable (where progeny are less successful). Over evolutionary time, females can increase their level of sperm selection (measured as the proportion of unfavourable sperm eliminated) by paying a fecundity cost. Males can regulate sperm allocations depending on whether they will be favoured or disfavoured, but increasing sperm allocation reduces their mating rate. The resolution of this game depends on whether males are equal, or unequal. Males could be equal: each is favoured with probability, p, reflecting the proportion of females in the population that favour his ejaculate (the 'random-roles' model); different males are favoured by different sets of females. Alternatively, males could be unequal: given males are perceived consistently by all females as two distinct types, favoured and disfavoured, where p is now the frequency of the favoured male type in the population (the 'constant-types' model). In both cases, the evolutionarily stable strategy (ESS) is for females initially to increase sperm selection from zero as the viability of offspring from unfavourable ejaculates falls below that of favourable ejaculates. But in the random-roles model, sperm selection decreases again towards zero as the unfavourable ejaculates become disastrous (i.e. as their progeny viability decreases towards zero). This occurs because males avoid expenditure in unfavourable matings, to conserve sperm for matings in the favoured role where their offspring have high viability, thus allowing females to relax sperm selection. If sperm selection is costly to females, ESS sperm selection is high across a region of intermediate viabilities. If it is uncostly, there is no ESS in this region unless sperm limitation (i.e. some eggs fail to be fertilized because sperm numbers are too low) is included into the model. In the constant-types model, no relaxation of sperm selection occurs at very low viabilities of disfavoured male progeny. If sperm selection is sufficiently costly, ESS sperm selection increases as progeny viability decreases down towards zero; but if it is uncostly, there is no ESS at the lowest viabilities, and unlike the random-roles model, this cannot be stabilized by including sperm limitation. Sperm allocations in the ESS regions differ between the two models. With random roles, males always allocate more sperm in the favoured role. With constant types, the male type that is favoured allocates less sperm than the disfavoured type. These results suggests that empiricists studying cryptic female choice and sperm allocation patterns need to determine whether sperm selection is applied differently, or consistently, on given males by different females in the same population.

Sharing Resources In Mobile/Satellite Communications

NASA Technical Reports Server (NTRS)

Yan, Tsun-Yee; Sue, Miles K.

1992-01-01

Report presents preliminary theoretical analysis of several alternative schemes for allocation of satellite resource among terrestrial subscribers of landmobile/satellite communication system. Demand-access and random-access approaches under code-division and frequency-division concepts compared.

Randomized controlled trials in evidence-based mental health care: getting the right answer to the right question.

PubMed

Essock, Susan M; Drake, Robert E; Frank, Richard G; McGuire, Thomas G

2003-01-01

The purpose of clinical research is to answer this question: Would a new treatment, when added to the existing range of treatment options available in practice, help patients? Randomized controlled trials (RCTs)--in particular, double-blind RCTs--have important methodological advantages over observational studies for addressing this question. These advantages, however, come at a price. RCTs compare treatments using a particular allocation rule for assigning patients to treatments (random assignment) that does not mimic real-world practice. "Favorable" results from an RCT indicating that a new treatment is superior to existing treatments are neither necessary nor sufficient for establishing a "yes" answer to the question posed above. Modeled on an experimental design, RCTs are expensive in time and money and must compare simple differences in treatments. Findings have a high internal validity but may not address the needs of the field, particularly where treatment is complex and rapidly evolving. Design of clinical research needs to take account of the way treatments are allocated in actual practice and include flexible designs to answer important questions most effectively.

Laboratory animal research published in plastic surgery journals in 2014 has extensive waste: A systematic review.

PubMed

Freshwater, M Felix

2015-11-01

Laboratory animal research must be designed in a manner that minimizes bias if it is to yield valid and reproducible results. In 2009, a survey that examined 271 animal studies found that 87% did not use randomization and 86% did not use blinding. This has been called "research waste" because it wasted time and resources. This systematic review measured the quantity of research waste in plastic surgery journals in 2014. The PRISMA-P protocol was used. SCOPUS and PubMed searches were done for all animal studies published in 2014 in Aesthetic Plast Surg, Aesthet Surg J, Ann Plast Surg, JPRAS, J Plast Surg Hand Surg and Plast Reconstr Surg. These were supplemented by manual searches of the 2014 issues not indexed. Articles were analyzed for descriptions of randomization, randomization methodology, allocation concealment, and blinding of the primary outcome assessment. Corresponding authors who mentioned randomization without elaborating were emailed for details. 112 of 154 articles met the inclusion criteria. Only 24/112 (21.4%) had blinding of the primary outcome measure, 28/110 (25.5%) of articles that required randomization mentioned it. While 12/28 articles clearly described randomizing the intervention, only 4/28 described the method of randomization, and 2/28 mentioned allocation concealment. Only two authors responded and described the randomization methodology. The quality of plastic surgery laboratory animal research published in 2014 was poor. Use of the National Centre for the Replacement Refinement & Reduction of Animals in Research's "Animal Research: Reporting In Vivo Experiments" (ARRIVE) Guidelines by authors, and enforcement of them by editors and reviewers could improve research quality and reduce waste. Copyright © 2015 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Randomised clinical trials with clinician-preferred treatment.

PubMed

Korn, E L; Baumrind, S

1991-01-19

The standard design for randomised clinical trials may be inappropriate when the clinician believes that one of the treatments being tested is superior for the patient, or when the clinician has a preference for one of the treatments. For such instances the suggestion is that the patient is randomly allocated to treatment only when there is clinical disagreement about treatment of choice for that patient, and then the patient is assigned to a clinician who had thought that the regimen allocated is the one most appropriate for that patient.

Revisiting sample size: are big trials the answer?

PubMed

Lurati Buse, Giovanna A L; Botto, Fernando; Devereaux, P J

2012-07-18

The superiority of the evidence generated in randomized controlled trials over observational data is not only conditional to randomization. Randomized controlled trials require proper design and implementation to provide a reliable effect estimate. Adequate random sequence generation, allocation implementation, analyses based on the intention-to-treat principle, and sufficient power are crucial to the quality of a randomized controlled trial. Power, or the probability of the trial to detect a difference when a real difference between treatments exists, strongly depends on sample size. The quality of orthopaedic randomized controlled trials is frequently threatened by a limited sample size. This paper reviews basic concepts and pitfalls in sample-size estimation and focuses on the importance of large trials in the generation of valid evidence.

Multimedia transmission in MC-CDMA using adaptive subcarrier power allocation and CFO compensation

NASA Astrophysics Data System (ADS)

Chitra, S.; Kumaratharan, N.

2018-02-01

Multicarrier code division multiple access (MC-CDMA) system is one of the most effective techniques in fourth-generation (4G) wireless technology, due to its high data rate, high spectral efficiency and resistance to multipath fading. However, MC-CDMA systems are greatly deteriorated by carrier frequency offset (CFO) which is due to Doppler shift and oscillator instabilities. It leads to loss of orthogonality among the subcarriers and causes intercarrier interference (ICI). Water filling algorithm (WFA) is an efficient resource allocation algorithm to solve the power utilisation problems among the subcarriers in time-dispersive channels. The conventional WFA fails to consider the effect of CFO. To perform subcarrier power allocation with reduced CFO and to improve the capacity of MC-CDMA system, residual CFO compensated adaptive subcarrier power allocation algorithm is proposed in this paper. The proposed technique allocates power only to subcarriers with high channel to noise power ratio. The performance of the proposed method is evaluated using random binary data and image as source inputs. Simulation results depict that the bit error rate performance and ICI reduction capability of the proposed modified WFA offered superior performance in both power allocation and image compression for high-quality multimedia transmission in the presence of CFO and imperfect channel state information conditions.

Molecular and Cellular Mechanisms for Trapping and Activating Emotional Memories

PubMed Central

Cai, Denise J.; Sano, Yoshitake; Lee, Yong-Seok; Zhou, Yu; Bekal, Pallavi; Deisseroth, Karl; Silva, Alcino J.

2016-01-01

Recent findings suggest that memory allocation to specific neurons (i.e., neuronal allocation) in the amygdala is not random, but rather the transcription factor cAMP-response element binding protein (CREB) modulates this process, perhaps by regulating the transcription of channels that control neuronal excitability. Here, optogenetic studies in the mouse lateral amygdala (LA) were used to demonstrate that CREB and neuronal excitability regulate which neurons encode an emotional memory. To test the role of CREB in memory allocation, we overexpressed CREB in the lateral amygdala to recruit the encoding of an auditory-fear conditioning (AFC) memory to a subset of neurons. Then, post-training activation of these neurons with Channelrhodopsin-2 was sufficient to trigger recall of the memory for AFC, suggesting that CREB regulates memory allocation. To test the role of neuronal excitability in memory allocation, we used a step function opsin (SFO) to transiently increase neuronal excitability in a subset of LA neurons during AFC. Post-training activation of these neurons with Volvox Channelrhodopsin-1 was able to trigger recall of that memory. Importantly, our studies show that activation of the SFO did not affect AFC by either increasing anxiety or by strengthening the unconditioned stimulus. Our findings strongly support the hypothesis that CREB regulates memory allocation by modulating neuronal excitability. PMID:27579481

Stochastic Optimization For Water Resources Allocation

NASA Astrophysics Data System (ADS)

Yamout, G.; Hatfield, K.

2003-12-01

For more than 40 years, water resources allocation problems have been addressed using deterministic mathematical optimization. When data uncertainties exist, these methods could lead to solutions that are sub-optimal or even infeasible. While optimization models have been proposed for water resources decision-making under uncertainty, no attempts have been made to address the uncertainties in water allocation problems in an integrated approach. This paper presents an Integrated Dynamic, Multi-stage, Feedback-controlled, Linear, Stochastic, and Distributed parameter optimization approach to solve a problem of water resources allocation. It attempts to capture (1) the conflict caused by competing objectives, (2) environmental degradation produced by resource consumption, and finally (3) the uncertainty and risk generated by the inherently random nature of state and decision parameters involved in such a problem. A theoretical system is defined throughout its different elements. These elements consisting mainly of water resource components and end-users are described in terms of quantity, quality, and present and future associated risks and uncertainties. Models are identified, modified, and interfaced together to constitute an integrated water allocation optimization framework. This effort is a novel approach to confront the water allocation optimization problem while accounting for uncertainties associated with all its elements; thus resulting in a solution that correctly reflects the physical problem in hand.

A Simple Probabilistic Combat Model

DTIC Science & Technology

2016-06-13

This page intentionally left blank. 1. INTRODUCTION The Lanchester combat model1 is a simple way to assess the effects of quantity and quality...case model. For the random case, assume R red weapons are allocated to B blue weapons randomly. We are interested in the distribution of weapons...since the initial condition is very close to the break even line. What is more interesting is that the probability density tends to concentrate at

Optimal allocation of testing resources for statistical simulations

NASA Astrophysics Data System (ADS)

Quintana, Carolina; Millwater, Harry R.; Singh, Gulshan; Golden, Patrick

2015-07-01

Statistical estimates from simulation involve uncertainty caused by the variability in the input random variables due to limited data. Allocating resources to obtain more experimental data of the input variables to better characterize their probability distributions can reduce the variance of statistical estimates. The methodology proposed determines the optimal number of additional experiments required to minimize the variance of the output moments given single or multiple constraints. The method uses multivariate t-distribution and Wishart distribution to generate realizations of the population mean and covariance of the input variables, respectively, given an amount of available data. This method handles independent and correlated random variables. A particle swarm method is used for the optimization. The optimal number of additional experiments per variable depends on the number and variance of the initial data, the influence of the variable in the output function and the cost of each additional experiment. The methodology is demonstrated using a fretting fatigue example.

Randomized clinical trial of postoperative strontium-90 radiation therapy for pterygia: treatment using 30 Gy/3 fractions vs. 40 Gy/4 fractions.

PubMed

Nakamatsu, Kiyoshi; Nishimura, Yasumasa; Kanamori, Shuichi; Koike, Ryuta; Tachibana, Izumi; Nishikawa, Tatsuyuki; Shibata, Toru

2011-07-01

Postoperative adjuvant treatment with strontium-90 radiation therapy (RT) is a proven technique for reducing the recurrence of pterygium. This randomized trial was conducted to evaluate whether a total dose of 40 Gy provides a better local control rate than a total dose of 30 Gy for surgically resected pterygia. A single institutional randomized trial was conducted. Between 1999 and 2003, 74 pterygia in 71 patients were randomly allocated to 30 Gy/3 fractions/15 days (arm A) or to 40 Gy/4 fractions/22 days (arm B). Only primary pterygia for which RT could be started within 3 days of surgical resection were included. Postoperative RT was given by a strontium-90 eye applicator, and a dose of 10 Gy per fraction was delivered in weekly fractions (day 1, 8, 15, 22). Of the 74 pterygia treated, 73 in 70 patients were analyzed. Of the 73 pterygia, 41 were allocated to arm A, and the remaining 32 to arm B. The 2-year local control rates for arm A and arm B were 85% and 75%, respectively, without significant difference. No serious acute and late complications were noted in either arm. Our new standard fractionation for postoperative RT for pterygia is 30 Gy/3 fractions.

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

PubMed

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

2017-01-24

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

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

PubMed

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

2016-03-15

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

A randomized controlled trial of fresh frozen plasma for coagulopathy in Russell's viper (Daboia russelii) envenoming.

PubMed

Isbister, G K; Jayamanne, S; Mohamed, F; Dawson, A H; Maduwage, K; Gawarammana, I; Lalloo, D G; de Silva, H J; Scorgie, F E; Lincz, L F; Buckley, N A

2017-04-01

Essentials Russell's viper envenoming is a major health issue in South Asia and causes coagulopathy. We studied the effect of fresh frozen plasma and two antivenom doses on correcting coagulopathy. Fresh frozen plasma did not hasten recovery of coagulopathy. Low-dose antivenom did not worsen coagulopathy. Background Russell's viper (Daboia russelii) envenoming is a major health issue in South Asia and causes venom-induced consumption coagulopathy (VICC). Objectives To investigate the effects of fresh frozen plasma (FFP) and two antivenom doses in correcting VICC. Methods We undertook an open-label randomized controlled trial in patients with VICC at two Sri Lankan hospitals. Patients with suspected Russell's viper bites and coagulopathy were randomly allocated (1 : 1) to high-dose antivenom (20 vials) or low-dose antivenom (10 vials) plus 4 U of FFP. The primary outcome was the proportion of patients with an International Normalized Ratio (INR) of < 2 at 6 h after antivenom administration. Secondary outcomes included anaphylaxis, major hemorrhage, death, and clotting factor recovery. Results From 214 eligible patients, 141 were randomized: 71 to high-dose antivenom, and 70 to low-dose antivenom/FFP; five had no post-antivenom blood tests. The groups were similar except for a delay of 1 h in antivenom administration for FFP patients. Six hours after antivenom administration, 23 of 69 (33%) patients allocated to high-dose antivenom had an INR of < 2, as compared with 28 of 67 (42%) allocated to low-dose antivenom/FFP (absolute difference 8%; 95% confidence interval - 8% to 25%). Fifteen patients allocated to FFP did not receive it. Severe anaphylaxis occurred equally frequently in each group. One patient given FFP developed transfusion-related acute lung injury. Three deaths occurred in low-dose antivenom/FFP patients, including one intracranial hemorrhage. There was no difference in recovery rates of INR or fibrinogen, but there was more rapid initial recovery of factor V and FX in FFP patients. Conclusion FFP after antivenom administration in patients with Russell's viper bites did not hasten recovery of coagulopathy. Low-dose antivenom/FFP did not worsen VICC, suggesting that low-dose antivenom is sufficient. © 2017 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.

The effect of telephone reminders on attendance in respiratory outpatient clinics.

PubMed

Roberts, Nicola; Meade, Karen; Partridge, Martyn

2007-04-01

Patient non-attendance is an area of concern for all health care providers. A randomized controlled trial was undertaken to investigate whether reminder telephone calls improved attendance at respiratory outpatient clinics in the English National Health Service (NHS). Patients were randomly allocated into one of two groups, either telephone reminder group or usual care. The telephone reminder group received a reminder telephone call between 9 am and 5 pm during the week prior to their appointment. Attendance and demographic information (age, sex, diagnosis and home postcode) were recorded. A total of 504 patients were recruited, 258 patients were allocated to the control group and 246 patients were allocated to the telephone reminder group. Fifty-eight percent of the patients allocated to the telephone reminder group were not contactable. Within the telephone reminder group, of the 104 patients who could be contacted, 86% attended. There was a significant 15% increase in attendance in the contacted group (n = 104) when compared both with the control group (71%, n = 258) and with the patients who could not be contacted (68%, n = 142) (P = 0.007; P = 0.004). It was estimated that the cost of telephoning 200 patients could be offset by preventing one non-attendance. Routine telephoning of outpatients should become standard practice if reducing non-attendance is thought to be desirable, but general practitioner (GP) referral letters and hospital records of current hospital outpatients need to include an up-to-date telephone number. Consideration should be given to 'out-of-hours' reminder calls to maximize the contact rate.

Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design.

PubMed

Mathe, Nonsikelelo; Johnson, Steven T; Wozniak, Lisa A; Majumdar, Sumit R; Johnson, Jeffrey A

2015-08-25

Randomized controlled trials are considered the "gold standard" for scientific rigor in the assessment of benefits and harms of interventions in healthcare. They may not always be feasible, however, when evaluating quality improvement interventions in real-world healthcare settings. Non-randomized controlled trials (NCTs) are designed to answer questions of effectiveness of interventions in routine clinical practice to inform a decision or process. The on-off NCT design is a relatively new design where participant allocation is by alternation. In alternation, eligible patients are allocated to the intervention "on" or control "off " groups in time series dependent sequential clusters. We used two quality improvement studies undertaken in a Canadian primary care setting to illustrate the features of the on-off design. We also explored the perceptions and experiences of healthcare providers tasked with implementing the on-off study design. The on-off design successfully allocated patients to intervention and control groups. Imbalances between baseline variables were attributed to chance, with no detectable biases. However, healthcare providers' perspectives and experiences with the design in practice reveal some conflict. Specifically, providers described the process of allocating patients to the off group as unethical and immoral, feeling it was in direct conflict with their professional principle of providing care for all. The degree of dissatisfaction seemed exacerbated by: 1) the patient population involved (e.g., patient population viewed as high-risk (e.g., depressed or suicidal)), 2) conducting assessments without taking action (e.g., administering the PHQ-9 and not acting on the results), and 3) the (non-blinded) allocation process. Alternation, as in the on-off design, is a credible form of allocation. The conflict reported by healthcare providers in implementing the design, while not unique to the on-off design, may be alleviated by greater emphasis on the purpose of the research and having research assistants allocate patients and collect data instead of the healthcare providers implementing the trial. In addition, consultation with front-line staff implementing the trials with an on-off design on appropriateness to the setting (e.g., alignment with professional values and the patient population served) may be beneficial. Health Eating and Active Living with Diabetes: ClinicalTrials.gov identifier: NCT00991380. Date registered: 7 October 2009. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Clintrials.gov Identifier: NCT01328639 Date registered: 30 March 2011.

Distortion outage minimization in Nakagami fading using limited feedback

NASA Astrophysics Data System (ADS)

Wang, Chih-Hong; Dey, Subhrakanti

2011-12-01

We focus on a decentralized estimation problem via a clustered wireless sensor network measuring a random Gaussian source where the clusterheads amplify and forward their received signals (from the intra-cluster sensors) over orthogonal independent stationary Nakagami fading channels to a remote fusion center that reconstructs an estimate of the original source. The objective of this paper is to design clusterhead transmit power allocation policies to minimize the distortion outage probability at the fusion center, subject to an expected sum transmit power constraint. In the case when full channel state information (CSI) is available at the clusterhead transmitters, the optimization problem can be shown to be convex and is solved exactly. When only rate-limited channel feedback is available, we design a number of computationally efficient sub-optimal power allocation algorithms to solve the associated non-convex optimization problem. We also derive an approximation for the diversity order of the distortion outage probability in the limit when the average transmission power goes to infinity. Numerical results illustrate that the sub-optimal power allocation algorithms perform very well and can close the outage probability gap between the constant power allocation (no CSI) and full CSI-based optimal power allocation with only 3-4 bits of channel feedback.

The Differential Effects of Reward on Space- and Object-Based Attentional Allocation

PubMed Central

Shomstein, Sarah

2013-01-01

Estimating reward contingencies and allocating attentional resources to a subset of relevant information are the most important contributors to increasing adaptability of an organism. Although recent evidence suggests that reward- and attention-based guidance recruits overlapping cortical regions and has similar effects on sensory responses, the exact nature of the relationship between the two remains elusive. Here, using event-related fMRI on human participants, we contrasted the effects of reward on space- and object-based selection in the same experimental setting. Reward was either distributed randomly or biased a particular object. Behavioral and neuroimaging results show that space- and object-based attention is influenced by reward differentially. Space-based attentional allocation is mandatory, integrating reward information over time, whereas object-based attentional allocation is a default setting that is completely replaced by the reward signal. Nonadditivity of the effects of reward and object-based attention was observed consistently at multiple levels of analysis in early visual areas as well as in control regions. These results provide strong evidence that space- and object-based allocation are two independent attentional mechanisms, and suggest that reward serves to constrain attentional selection. PMID:23804086

Non-Orthogonal Random Access in MIMO Cognitive Radio Networks: Beamforming, Power Allocation, and Opportunistic Transmission

PubMed Central

Lin, Huifa; Shin, Won-Yong

2017-01-01

We study secondary random access in multi-input multi-output cognitive radio networks, where a slotted ALOHA-type protocol and successive interference cancellation are used. We first introduce three types of transmit beamforming performed by secondary users, where multiple antennas are used to suppress the interference at the primary base station and/or to increase the received signal power at the secondary base station. Then, we show a simple decentralized power allocation along with the equivalent single-antenna conversion. To exploit the multiuser diversity gain, an opportunistic transmission protocol is proposed, where the secondary users generating less interference are opportunistically selected, resulting in a further reduction of the interference temperature. The proposed methods are validated via computer simulations. Numerical results show that increasing the number of transmit antennas can greatly reduce the interference temperature, while increasing the number of receive antennas leads to a reduction of the total transmit power. Optimal parameter values of the opportunistic transmission protocol are examined according to three types of beamforming and different antenna configurations, in terms of maximizing the cognitive transmission capacity. All the beamforming, decentralized power allocation, and opportunistic transmission protocol are performed by the secondary users in a decentralized manner, thus resulting in an easy implementation in practice. PMID:28076402

Non-Orthogonal Random Access in MIMO Cognitive Radio Networks: Beamforming, Power Allocation, and Opportunistic Transmission.

PubMed

Lin, Huifa; Shin, Won-Yong

2017-01-01

We study secondary random access in multi-input multi-output cognitive radio networks, where a slotted ALOHA-type protocol and successive interference cancellation are used. We first introduce three types of transmit beamforming performed by secondary users, where multiple antennas are used to suppress the interference at the primary base station and/or to increase the received signal power at the secondary base station. Then, we show a simple decentralized power allocation along with the equivalent single-antenna conversion. To exploit the multiuser diversity gain, an opportunistic transmission protocol is proposed, where the secondary users generating less interference are opportunistically selected, resulting in a further reduction of the interference temperature. The proposed methods are validated via computer simulations. Numerical results show that increasing the number of transmit antennas can greatly reduce the interference temperature, while increasing the number of receive antennas leads to a reduction of the total transmit power. Optimal parameter values of the opportunistic transmission protocol are examined according to three types of beamforming and different antenna configurations, in terms of maximizing the cognitive transmission capacity. All the beamforming, decentralized power allocation, and opportunistic transmission protocol are performed by the secondary users in a decentralized manner, thus resulting in an easy implementation in practice.

Urn models for response-adaptive randomized designs: a simulation study based on a non-adaptive randomized trial.

PubMed

Ghiglietti, Andrea; Scarale, Maria Giovanna; Miceli, Rosalba; Ieva, Francesca; Mariani, Luigi; Gavazzi, Cecilia; Paganoni, Anna Maria; Edefonti, Valeria

2018-03-22

Recently, response-adaptive designs have been proposed in randomized clinical trials to achieve ethical and/or cost advantages by using sequential accrual information collected during the trial to dynamically update the probabilities of treatment assignments. In this context, urn models-where the probability to assign patients to treatments is interpreted as the proportion of balls of different colors available in a virtual urn-have been used as response-adaptive randomization rules. We propose the use of Randomly Reinforced Urn (RRU) models in a simulation study based on a published randomized clinical trial on the efficacy of home enteral nutrition in cancer patients after major gastrointestinal surgery. We compare results with the RRU design with those previously published with the non-adaptive approach. We also provide a code written with the R software to implement the RRU design in practice. In detail, we simulate 10,000 trials based on the RRU model in three set-ups of different total sample sizes. We report information on the number of patients allocated to the inferior treatment and on the empirical power of the t-test for the treatment coefficient in the ANOVA model. We carry out a sensitivity analysis to assess the effect of different urn compositions. For each sample size, in approximately 75% of the simulation runs, the number of patients allocated to the inferior treatment by the RRU design is lower, as compared to the non-adaptive design. The empirical power of the t-test for the treatment effect is similar in the two designs.

Technical Report 1205: A Simple Probabilistic Combat Model

DTIC Science & Technology

2016-07-08

This page intentionally left blank. 1. INTRODUCTION The Lanchester combat model1 is a simple way to assess the effects of quantity and quality...model. For the random case, assume R red weapons are allocated to B blue weapons randomly. We are interested in the distribution of weapons assigned...the initial condition is very close to the break even line. What is more interesting is that the probability density tends to concentrate at either a

Randomization in clinical trials: stratification or minimization? The HERMES free simulation software.

PubMed

Fron Chabouis, Hélène; Chabouis, Francis; Gillaizeau, Florence; Durieux, Pierre; Chatellier, Gilles; Ruse, N Dorin; Attal, Jean-Pierre

2014-01-01

Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. This software will help investigators choose the appropriate randomization method in future two-arm trials.

Effects of royal jelly supplementation on glycemic control and oxidative stress factors in type 2 diabetic female: a randomized clinical trial.

PubMed

Pourmoradian, Samira; Mahdavi, Reza; Mobasseri, Majid; Faramarzi, Elnaz; Mobasseri, Mehrnoosh

2014-05-01

It has been proposed that royal jelly has antioxidant properties and may improve oxidative stress and glycemic control. Therefore, we investigated the effects of royal jelly supplementation in diabetic females. In this pilot, parallel design randomized clinical trial, 50 female volunteers with type 2 diabetes were randomly allocated to the supplemented (25, cases) and placebo (25, cases) groups, based on random block procedure produced by Random Allocation Software, given a daily dose of 1,000 mg royal jelly soft gel or placebo, respectively, for 8 weeks. Before and after intervention, glycemic control indices, antioxidant and oxidative stress factors were measured. After royal jelly supplementation, the mean fasting blood glucose decreased remarkably (163.05±42.51 mg/dL vs. 149.68±42.7 mg/dL). Royal jelly supplementation resulted in significant reduction in the mean serum glycosylated hemoglobin levels (8.67%±2.24% vs. 7.05%±1.45%, P=0.001) and significant elevation in the mean insulin concentration (70.28±29.16 pmol/L vs. 86.46±27.50 pmol/L, P=0.01). Supplementation significantly increased erythrocyte superoxidase dismutase and glutathione peroxidase activities and decreased malondialdehyde levels (P<0.05). At the end of study, the mean total antioxidant capacity elevated insignificantly in both groups. On the basis of our findings, it seems that royal jelly supplementation may be beneficial in controlling diabetes outcomes. Further studies with larger sample size are warranted.

Analysis of causality from observational studies and its application in clinical research in Intensive Care Medicine.

PubMed

Coscia Requena, C; Muriel, A; Peñuelas, O

2018-02-28

Random allocation of treatment or intervention is the key feature of clinical trials and divides patients into treatment groups that are approximately balanced for baseline, and therefore comparable covariates except for the variable treatment of the study. However, in observational studies, where treatment allocation is not random, patients in the treatment and control groups often differ in covariates that are related to intervention variables. These imbalances in covariates can lead to biased estimates of the treatment effect. However, randomized clinical trials are sometimes not feasible for ethical, logistical, economic or other reasons. To resolve these situations, interest in the field of clinical research has grown in designing studies that are most similar to randomized experiments using observational (i.e. non-random) data. Observational studies using propensity score analysis methods have been increasing in the scientific papers of Intensive Care. Propensity score analyses attempt to control for confounding in non-experimental studies by adjusting for the likelihood that a given patient is exposed. However, studies with propensity indexes may be confusing, and intensivists are not familiar with this methodology and may not fully understand the importance of this technique. The objectives of this review are: to describe the fundamentals of propensity index methods; to present the techniques to adequately evaluate propensity index models; to discuss the advantages and disadvantages of these techniques. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

Thymoglobulin induction in liver transplant recipients with a tacrolimus, mycophenolate mofetil, and steroid immunosuppressive regimen: a five-year randomized prospective study.

PubMed

Boillot, Olivier; Seket, Belhassen; Dumortier, Jérôme; Pittau, Gabriella; Boucaud, Catherine; Bouffard, Yves; Scoazec, Jean-Yves

2009-11-01

This randomized, comparative study assessed the long-term efficacy and tolerability of thymoglobulin (TMG) induction in 93 liver transplant patients with an initial regimen of tacrolimus (Tac), mycophenolate mofetil (MMF), and steroids. Forty-four patients were randomly allocated to the TMG+ group, and 49 patients were randomly allocated to the TMG- group. In both groups, Tac was given orally at the initial daily dose of 0.075 mg/kg twice daily, and MMF was given at the initial daily dose of 2 g/day. Steroid withdrawal was planned at 3 months after liver transplantation. The results were evaluated with respect to acute rejection incidence, patient and graft survival, graft function, and medical complications until 5 years or death for all patients. No significant differences were found between groups for the incidence of acute rejection at 5 years (11.4% versus 14.3%), 5-year patient survival (77.3% versus 87.8%), graft function, or postoperative renal function. One patient in the TMG- group underwent retransplantation. There was no difference between groups with respect to the incidence of medical complications, excepted for a higher rate of leukopenia in the TMG+ group, during the 5-year follow-up. In conclusion, the results of this prospective randomized study suggest that the addition of TMG to a triple immunosuppressive regimen (Tac, MMF, and steroids) did not modify the incidence of acute rejection episodes or long-term survival and was responsible for increased leukopenia rates.

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

PubMed

Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

2014-02-24

The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. ClinicalTrials.gov identifier NCT01232764.

Artemisinin derivatives for treating severe malaria.

PubMed

McIntosh, H M; Olliaro, P

2000-01-01

Artemisinin derivatives may have advantages over quinoline drugs for treating severe malaria since they are fast acting and effective against quinine resistant malaria parasites. The objective of this review was to assess the effects of artemisinin drugs for severe and complicated falciparum malaria in adults and children. We searched the Cochrane Infectious Diseases Group trials register, Cochrane Controlled Trials Register, Medline, Embase, Science Citation Index, Lilacs, African Index Medicus, conference abstracts and reference lists of articles. We contacted organisations, researchers in the field and drug companies. Randomised and pseudo-randomised trials comparing artemisinin drugs (rectal, intramuscular or intravenous) with standard treatment, or comparisons between artemisinin derivatives in adults or children with severe or complicated falciparum malaria. Eligibility, trial quality assessment and data extraction were done independently by two reviewers. Study authors were contacted for additional information. Twenty three trials are included, allocation concealment was adequate in nine. Sixteen trials compared artemisinin drugs with quinine in 2653 patients. Artemisinin drugs were associated with better survival (mortality odds ratio 0.61, 95% confidence interval 0.46 to 0.82, random effects model). In trials where concealment of allocation was adequate (2261 patients), this was barely statistically significant (odds ratio 0.72, 95% CI 0.54 to 0.96, random effects model). In 1939 patients with cerebral malaria, mortality was also lower with artemisinin drugs overall (odds ratio 0.63, 95% CI 0.44 to 0.88, random effects model). The difference was not significant however when only trials reporting adequate concealment of allocation were analysed (odds ratio 0.78, 95% CI 0.55 to 1.10, random effects model) based on 1607 patients. No difference in neurological sequelae was shown. Compared with quinine, artemisinin drugs showed faster parasite clearance from the blood and similar adverse effects. The evidence suggests that artemisinin drugs are no worse than quinine in preventing death in severe or complicated malaria. No artemisinin derivative appears to be better than the others.

Effectiveness of Different Bristle Designs of Toothbrushes and Periodontal Status among Fixed Orthodontic Patients: A Double-blind Crossover Design.

PubMed

Naik, Sandhya P; Punathil, Sameer; Shetty, Praveena; Jayanti, Ipsita; Jalaluddin, Md; Avijeeta, Anisha

2018-02-01

The aim of the present study was to evaluate the effectiveness of different bristle designs of toothbrushes and the periodontal status among patients undergoing fixed orthodontic treatment. This randomized controlled trial (RCT) consisted of 45 adolescents (comprising 20 males and 25 females) undergoing fixed orthodontic treatment. The study participants were randomly allocated to three groups, each group being assigned a locally available toothbrush with a particular design of toothbrush bristle. In the first test phase, group I study participants were allocated to toothbrush with flat bristles, group II study subjects were allocated to toothbrush with zigzag bristles, and group III study participants were allocated to toothbrush with crisscross bristles. The study participants were recalled after 4 weeks to check the effectiveness of the allocated toothbrushes. A washout period of 1 week was maintained to ensure that there was no carryover effect of the different bristle designs. In the second test phase, each patient used the opposite toothbrush bristle design (group I: toothbrush with zigzag bristles, group II: toothbrush with crisscross bristles, and group III: toothbrush with flat bristles). Plaque scores were measured using Turesky-Gilmore-Glickman modification of Quigley-Hein plaque index (PI). In both phase 1 and 2 of this RCT, toothbrush with crisscross bristles exhibited maximum plaque reduction among the three different bristle design toothbrushes following 30 days (p = 0.312 ± 0.102 and 0.280 ± 0.110, respectively), which was statistically significant. It was concluded that all the three designs of toothbrushes were effective in removing plaque in patients with fixed orthodontic appliances. But among the three different toothbrushes, toothbrush with crisscross bristles showed the highest mean plaque reduction. Plaque accumulation around the orthodontic brackets and gingival margins is quite common among the fixed orthodontic patients, who encounter difficulty in maintaining good oral hygiene. Specially designed toothbrushes are very essential for effective plaque removal among the patients undergoing fixed orthodontic treatment.

No evidence for intervention-dependent influence of methodological features on treatment effect.

PubMed

Jacobs, Wilco C H; Kruyt, Moyo C; Moojen, Wouter A; Verbout, Ab J; Oner, F Cumhur

2013-12-01

The goal of this systematic review was to evaluate if the influence of methodological features on treatment effect differs between types of intervention. MEDLINE, Embase, Web of Science, Cochrane methodology register, and reference lists were searched for meta-epidemiologic studies on the influence of methodological features on treatment effect. Studies analyzing influence of methodological features related to internal validity were included. We made a distinction among surgical, pharmaceutical, and therapeutical as separate types of intervention. Heterogeneity was calculated to identify differences among these types. Fourteen meta-epidemiologic studies were found with 51 estimates of influence of methodological features on treatment effect. Heterogeneity was observed among the intervention types for randomization. Surgical intervention studies showed a larger treatment effect when randomized; this was in contrast to pharmaceutical studies that found the opposite. For allocation concealment and double blinding, the influence of methodological features on the treatment effect was comparable across different types of intervention. For the remaining methodological features, there were insufficient observations. The influence of allocation concealment and double blinding on the treatment effect is consistent across studies of different interventional types. The influence of randomization although, may be different between surgical and nonsurgical studies. Copyright © 2013 Elsevier Inc. All rights reserved.

Challenges in defining an optimal approach to formula-based allocations of public health funds in the United States.

PubMed

Buehler, James W; Holtgrave, David R

2007-03-29

Controversy and debate can arise whenever public health agencies determine how program funds should be allocated among constituent jurisdictions. Two common strategies for making such allocations are expert review of competitive applications and the use of funding formulas. Despite widespread use of funding formulas by public health agencies in the United States, formula allocation strategies in public health have been subject to relatively little formal scrutiny, with the notable exception of the attention focused on formula funding of HIV care programs. To inform debates and deliberations in the selection of a formula-based approach, we summarize key challenges to formula-based funding, based on prior reviews of federal programs in the United States. The primary challenge lies in identifying data sources and formula calculation methods that both reflect and serve program objectives, with or without adjustments for variations in the cost of delivering services, the availability of local resources, capacity, or performance. Simplicity and transparency are major advantages of formula-based allocations, but these advantages can be offset if formula-based allocations are perceived to under- or over-fund some jurisdictions, which may result from how guaranteed minimum funding levels are set or from "hold-harmless" provisions intended to blunt the effects of changes in formula design or random variations in source data. While fairness is considered an advantage of formula-based allocations, the design of a formula may implicitly reflect unquestioned values concerning equity versus equivalence in setting funding policies. Whether or how past or projected trends are taken into account can also have substantial impacts on allocations. Insufficient attention has been focused on how the approach to designing funding formulas in public health should differ for treatment or service versus prevention programs. Further evaluations of formula-based versus competitive allocation methods are needed to promote the optimal use of public health funds. In the meantime, those who use formula-based strategies to allocate funds should be familiar with the nuances of this approach.

A Block Randomized Controlled Trial of a Brief Smoking Cessation Counselling and Advice through Short Message Service on Participants Who Joined the Quit to Win Contest in Hong Kong

ERIC Educational Resources Information Center

Chan, Sophia S. C.; Wong, David C. N.; Cheung, Yee Tak Derek; Leung, Doris Y. P.; Lau, Lisa; Lai, Vienna; Lam, Tai-Hing

2015-01-01

The present trial examined the effectiveness of brief interventions for smokers who joined the Hong Kong Quit to Win Contest to quit smoking. A block randomized controlled trial allocated 1003 adult daily smokers to three groups: (i) The TEL group (n = 338) received a 5-min nurse-led telephone counselling; (ii) The SMS group (n = 335) received…

Effectiveness of the clinical teaching associate model to improve clinical learning outcomes: a randomized controlled trial.

PubMed

Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh

2014-01-01

This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.

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.

Randomized controlled trial of perioperative antimicrobial therapy based on the results of preoperative bile cultures in patients undergoing biliary reconstruction.

PubMed

Okamura, Kunishige; Tanaka, Kimitaka; Miura, Takumi; Nakanishi, Yoshitsugu; Noji, Takehiro; Nakamura, Toru; Tsuchikawa, Takahiro; Okamura, Keisuke; Shichinohe, Toshiaki; Hirano, Satoshi

2017-07-01

The high frequency of surgical site infections (SSIs) after hepato-pancreato-biliary (HPB) surgery is a problem that needs to be addressed. This prospective, randomized, controlled study examined whether perioperative prophylactic use of antibiotics based on preoperative bile culture results in HPB surgery could decrease SSI. Participants comprised 126 patients who underwent HPB (bile duct, gallbladder, ampullary, or pancreatic) cancer surgery with biliary reconstruction at Hokkaido University Hospital between August 2008 and March 2013 (UMIN Clinical Trial Registry #00001278). Before surgery, subjects were randomly allocated to a targeted group administered antibiotics based on bile culture results or a standard group administered cefmetazole. The primary endpoint was SSI rates within 30 days after surgery. Secondary endpoint was SSI rates for each operative procedure. Of the 126 patients, 124 were randomly allocated (targeted group, n = 62; standard group, n = 62). Frequency of SSI after surgery was significantly lower in the targeted group (27 patients, 43.5%) than in the standard group (44 patients, 71.0%; P = 0.002). Among patients who underwent pancreaticoduodenectomy and hepatectomy, SSI occurred significantly less frequently in the targeted group (P = 0.001 and P = 0.025, respectively). This study demonstrated that preoperative bile culture-targeted administration of prophylactic antibiotics decreased SSIs following HBP surgery with biliary reconstruction. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol.

PubMed

Pérula-de-Torres, Luis Á; Martínez-Adell, Miguel Á; González-Blanco, Virginia; Baena-Díez, José M; Martín-Rioboó, Enrique; Parras-Rejano, Juan M; González-Lama, Jesús; Martín-Alvarez, Remedios; Ruiz-Moral, Roger; Fernández-García, José Á; Pérez-Díaz, Modesto; Ruiz-de-Castroviejo, Joaquin; Pérula-de-Torres, Carlos; Valero-Martín, Antonio; Roldán-Villalobos, Ana; Criado-Larumbe, Margarita; Burdoy-Joaquín, Emili; Coma-Solé, Montserrat; Cervera-León, Mercè; Cuixart-Costa, Lluís

2012-10-30

Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. The study is registered as NCT01291953 (ClinicalTrials.gob).

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

PubMed Central

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

2016-01-01

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

Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

PubMed Central

2013-01-01

Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. Methods/Design The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. Discussion This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the execution of the program and the resultant threats to the study, we discuss our analytical plan and intentions for endline data collection. Trials registration Current Controlled Trials ISRCTN76061874 PMID:23953975

Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group.

PubMed

Pradhan, Menno; Brinkman, Sally A; Beatty, Amanda; Maika, Amelia; Satriawan, Elan; de Ree, Joppe; Hasan, Amer

2013-08-16

This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the execution of the program and the resultant threats to the study, we discuss our analytical plan and intentions for endline data collection. Current Controlled Trials ISRCTN76061874.

Adaptive adjustment of the randomization ratio using historical control data

PubMed Central

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

2013-01-01

Background Prospective trial design often occurs in the presence of “acceptable” [1] historical control data. Typically this data is only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al. [2], succeeded a similar trial reported by Saltz et al. [3], and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS) characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors [4] are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure leads to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Limitations Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. Conclusions The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on pre-existing information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare. PMID:23690095

Adaptive adjustment of the randomization ratio using historical control data.

PubMed

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

2013-01-01

Prospective trial design often occurs in the presence of 'acceptable' historical control data. Typically, these data are only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al., succeeded a similar trial reported by Saltz et al., and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS), characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial's frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure lead to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on preexisting information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare.

Sample size allocation for food item radiation monitoring and safety inspection.

PubMed

Seto, Mayumi; Uriu, Koichiro

2015-03-01

The objective of this study is to identify a procedure for determining sample size allocation for food radiation inspections of more than one food item to minimize the potential risk to consumers of internal radiation exposure. We consider a simplified case of food radiation monitoring and safety inspection in which a risk manager is required to monitor two food items, milk and spinach, in a contaminated area. Three protocols for food radiation monitoring with different sample size allocations were assessed by simulating random sampling and inspections of milk and spinach in a conceptual monitoring site. Distributions of (131)I and radiocesium concentrations were determined in reference to (131)I and radiocesium concentrations detected in Fukushima prefecture, Japan, for March and April 2011. The results of the simulations suggested that a protocol that allocates sample size to milk and spinach based on the estimation of (131)I and radiocesium concentrations using the apparent decay rate constants sequentially calculated from past monitoring data can most effectively minimize the potential risks of internal radiation exposure. © 2014 Society for Risk Analysis.

Recovery of motor deficit accompanying sciatica--subgroup analysis of a randomized controlled trial.

PubMed

Overdevest, Gijsbert M; Vleggeert-Lankamp, Carmen L A M; Jacobs, Wilco C H; Brand, Ronald; Koes, Bart W; Peul, Wilco C

2014-09-01

In patients with sciatica due to a lumbar disc herniation, it is generally recommended to reserve surgical treatment for those who suffer from intolerable pain or those who demonstrate persistent symptoms after conservative management. Controversy exists about the necessity of early surgical intervention for those patients that have an additional motor deficit. The aim of this study was to compare the recovery of motor deficit among patients receiving early surgery to those receiving prolonged conservative treatment. Subgroup analysis of a randomized controlled trial. This subgroup analysis focuses on 150 (53%) of 283 patients with sciatica due to a lumbar disc herniation and whose symptoms at baseline (before randomization) were accompanied by a motor deficit. Motor deficit was assessed through manual muscle testing and graded according to the Medical Research Council (MRC) scale. In total, 150 patients with 6 to 12 weeks of sciatica due to a lumbar disc herniation and whose symptoms were accompanied by a moderate (MRC Grade 4) or severe (MRC Grade 3) motor deficit were randomly allocated to early surgery or prolonged conservative treatment. Repeated standardized neurologic examinations were performed at baseline and at 8, 26, and 52 weeks after randomization. This study was supported by a grant from the Netherlands Organization for Health Research and Development (ZonMW) and the Hoelen Foundation The Hague. Sciatica recovered among seven (10%) of the 70 patients assigned to early surgery before surgery could be performed, and of the 80 patients assigned to conservative treatment, 32 patients (40%) were treated surgically because of intolerable pain. Baseline severity of motor deficit was graded moderate in 84% of patients and severe in 16% of patients. Motor deficit recovered significantly faster among patients allocated to early surgery (p=.01), but the difference was no longer significant at 26 (p=.21) or 52 weeks (p=.92). At 1 year, complete recovery of motor deficit was found in 81% of patients allocated to early surgery and in 80% of patients allocated to prolonged conservative treatment. Perceived overall recovery of sciatica was directly related to the presence of an accompanying motor deficit. Severe motor deficit at baseline (odds ratio, 5.4; confidence interval, 1.7-17.4) and a lumbar disc herniation encompassing ≥25% of the cross-sectional area of the spinal canal (odds ratio, 6.4; confidence interval, 1.3-31.8) were the most important risk factors for persistent deficit at 1 year. Early surgery resulted in a faster recovery of motor deficit accompanying sciatica compared with prolonged conservative treatment but the difference was no longer significant during the final follow-up examination at 1 year. Copyright © 2014 Elsevier Inc. All rights reserved.

New Mathematical Strategy Using Branch and Bound Method

NASA Astrophysics Data System (ADS)

Tarray, Tanveer Ahmad; Bhat, Muzafar Rasool

In this paper, the problem of optimal allocation in stratified random sampling is used in the presence of nonresponse. The problem is formulated as a nonlinear programming problem (NLPP) and is solved using Branch and Bound method. Also the results are formulated through LINGO.

Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol.

PubMed

Alqualo-Costa, Renata; Thomé, Gustavo R; Perracini, Mônica R; Liebano, Richard E

2018-05-03

The aim of this study is to investigate the effects of low-level laser therapy and interferential current (IFC) on pain intensity, central sensitization, muscle strength and functional capacity in patients with knee osteoarthritis. Participants will be patients aged between 50 and 80 years, with knee osteoarthritis, pain intensity ranging from 3 to 8 points (0-10 scale), Lequesne Algofunctional Index ranging from 5 to 15 points, and Kellgren & Lawrence grade ≥2. A total of 168 patients will be randomly allocated into four groups as follows: active IFC + laser sham (G1), IFC sham + active laser (G2), active IFC + laser (G3) and IFC + laser sham (G4). Evaluators will be blinded to group allocation. Primary outcomes will be pain at rest and during movement measured with the visual analog pain scale. Clinical Trials Registry (NCT02898025. Registered on 20 April 2016).

Effects of a Meditation Program on Nurses' Power and Quality of Life.

PubMed

Chang, Sun Ju; Kwak, Eun Young; Hahm, Bong-Jin; Seo, Se Hee; Lee, Da Woon; Jang, Sun Joo

2016-07-01

This study evaluated the effects of meditation programs on nurses' power and quality of life. In this study, Barrett's power theory derived from Rogers' unitary human being science was used as a theoretical framework. A randomized controlled design with 50 recruited and randomly allocated participants was used. The results demonstrated that the eight-week meditation program significantly improved nurses' power and quality of life. These results suggest that meditation has positive effects on power and quality of life. © The Author(s) 2016.

A pilot randomized controlled trial of a self-management group intervention for people with early-stage dementia (The SMART study).

PubMed

Quinn, Catherine; Toms, Gill; Jones, Carys; Brand, Andrew; Edwards, Rhiannon Tudor; Sanders, Fiona; Clare, Linda

2016-05-01

Self-management equips people to manage the symptoms and lifestyle changes that occur in long-term health conditions; however, there is limited evidence about its effectiveness for people with early-stage dementia. This pilot randomized controlled trial (RCT) explored the feasibility of a self-management intervention for people with early-stage dementia. The participants were people with early-stage dementia (n = 24) and for each participant a caregiver also took part. Participants were randomly allocated to either an eight-week self-management group intervention or treatment as usual (TAU). Assessments were conducted at baseline, three months and six months post-randomization by a researcher blind to group allocation. The primary outcome measure was self-efficacy score at three months. Thirteen people with dementia were randomized to the intervention and 11 to TAU. Two groups were run, the first consisting of six people with dementia and the second of seven people with dementia. There was a small positive effect on self-efficacy with the intervention group showing gains in self-efficacy compared to the TAU group at three months (d = 0.35), and this was maintained at six months (d = 0.23). In terms of intervention acceptability, attrition was minimal, adherence was good, and satisfaction ratings were high. Feedback from participants was analyzed with content analysis. The findings suggest the positive aspects of the intervention were that it fostered independence and reciprocity, promoted social support, offered information, and provided clinician support. This study has provided preliminary evidence that self-management may be beneficial for people with early-stage dementia.

Delayed versus immediate treatment for patients with acute hepatitis C: a randomised controlled non-inferiority trial.

PubMed

Deterding, Katja; Grüner, Norbert; Buggisch, Peter; Wiegand, Johannes; Galle, Peter R; Spengler, Ulrich; Hinrichsen, Holger; Berg, Thomas; Potthoff, Andrej; Malek, Nisar; Großhennig, Anika; Koch, Armin; Diepolder, Helmut; Lüth, Stefan; Feyerabend, Sandra; Jung, Maria Christina; Rogalska-Taranta, Magdalena; Schlaphoff, Verena; Cornberg, Markus; Manns, Michael P; Wedemeyer, Heiner

2013-06-01

Early treatment of acute hepatitis C virus (HCV) infection with interferon alfa monotherapy is very effective, with cure rates of greater than 85%. However, spontaneous clearance of HCV occurs in 10-50% of cases. We aimed to assess an alternative treatment strategy of delayed antiviral therapy in patients who do not eliminate the virus spontaneously compared with immediate treatment. In our open-label phase 3 non-inferiority trial, we enrolled adults (≥18 years) with acute hepatitis C but no HIV or hepatitis B co-infection at 72 centres in Germany. We randomly allocated patients with symptomatic acute hepatitis C (1:1) to receive immediate pegylated interferon alfa-2b treatment for 24 weeks or delayed treatment with pegylated interferon alfa-2b plus ribavirin (for 24 weeks) starting 12 weeks after randomisation if HCV RNA remained positive. We used a computer-generated randomisation sequence and block sizes of eight, stratified by bilirubin concentration. We assigned all asymptomatic patients to immediate treatment with pegylated interferon alfa-2b for 24 weeks. The primary endpoint was sustained HCV RNA negativity in all randomly allocated participants who completed screening (intention-to-treat analysis), with a non-inferiority margin of 10%. For the primary analysis, we calculated the virological response of patients in the immediate and delayed treatment groups and an absolute risk difference stratified by bilirubin status. The trial was stopped early on advice from the study advisory committee because of slow recruitment of participants. This study is registered, number ISRCTN88729946. Between April, 2004, and February, 2010, we recruited 107 symptomatic and 25 asymptomatic patients. 37 (67%) of 55 symptomatic patients randomly allocated to receive immediate treatment and 28 (54%) of 52 symptomatic patients randomly allocated to receive delayed treatment had a sustained virological response (difference 13·7%, 95% CI -4·6 to 32·0; p=0·071). 18 (72%) of 25 asymptomatic patients had a sustained virological response. 22 (42%) of 52 symptomatic patients allocated to receive delayed treatment did not complete follow-up compared with 20 (25%) of 80 symptomatic or asymptomatic patients assigned immediate treatment (p=0·037). 11 symptomatic patients (21%) assigned delayed treatment had spontaneous HCV clearance. 14 patients who received delayed pegylated interferon alfa-2b plus ribavirin treatment and completed follow-up achieved sustained virological response. Delayed treatment is effective although not of equal efficacy to immediate treatment; coupled with the rate of spontaneous clearance it can reduce unnecessary treatment in closely monitored populations. Immediate treatment seems preferable in populations where loss to follow-up is great. German Network of Competence on Viral Hepatitis (HepNet, funded by the German Federal Ministry of Education and Research, grants 01KI0102, 01KI0401, and 01KI0601), MSD, Schering-Plough. Copyright © 2013 Elsevier Ltd. All rights reserved.

Allocation of attention during pursuit of large objects is no different than during fixation.

PubMed

Watamaniuk, Scott N J; Heinen, Stephen J

2015-01-01

Attention allocation during pursuit of a spot is usually characterized as asymmetric with more attention placed ahead of the target than behind it. However, attention is symmetrically allocated across larger pursuit stimuli. An unresolved issue is how tightly attention is constrained on large stimuli during pursuit. Although some work shows it is tightly locked to the fovea, other work shows it is allocated flexibly. To investigate this, we had observers perform a character identification task on large pursuit stimuli composed of arrays of five, nine, or 15 characters spaced between 0.6° and 4.0° apart. Initially, the characters were identical, but at a random time, they all changed briefly, rendering one of them unique. Observers identified the unique character. Consistent with previous literature, attention appeared narrow and symmetric around the pursuit target for tightly spaced (0.6°) characters. Increasing spacing dramatically expanded the attention scope, presumably by mitigating crowding. However, when we controlled for crowding, performance was limited by set size, suffering more for eccentric targets. Interestingly, the same limitations on attention allocation were observed with stationary and pursued stimuli-evidence that attention operates similarly during fixation and pursuit of a stimulus that extends into the periphery. The results suggest that attention is flexibly allocated during pursuit, but performance is limited by crowding and set size. In addition, performing the identification task did not hurt pursuit performance, further evidence that pursuit of large stimuli is relatively inattentive.

A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6 months from symptom onset. Early, intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) can delay the onset and progression of joint damage. The primary objective of the study is to investigate the value of magnetic resonance imaging (MRI) or radiography (X-ray) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA. Methods A double-blind, randomized controlled trial has been designed. Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6 months. Baseline adaptive randomization will be used to allocate participants to MRI, X-ray, or sham-intervention groups on a background of standard of care. Prognostic markers, treating physician, and baseline DMARD therapy will be used as intervention allocation parameters. The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images, respectively. Radiologists will score anonymized images for all patients regardless of intervention allocation. Disease progression will be determined based on the study-specific, inter-rater smallest detectable difference. Allocation-dependent, intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist. Negative reports will be delivered for the sham-intervention group. Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care. DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective. A sample size of 186 (62 per group) patients will be required to determine a 36% difference in pharmacological treatment escalation between the three groups with intermediate dispersion of data with 90% power at a 5% level of significance. Discussion This study will determine if monitoring RA and undifferentiated inflammatory arthritis patients using MRI and X-ray every 6 months over 2 years provides incremental evidence over standard of care to influence pharmacotherapeutic decision-making and ultimately hinder disease progression. Trial registration This trial has been registered at ClinicalTrials.gov: NCT00808496 (registered on 12 December 2008). PMID:24997587

Sample size re-estimation and other midcourse adjustments with sequential parallel comparison design.

PubMed

Silverman, Rachel K; Ivanova, Anastasia

2017-01-01

Sequential parallel comparison design (SPCD) was proposed to reduce placebo response in a randomized trial with placebo comparator. Subjects are randomized between placebo and drug in stage 1 of the trial, and then, placebo non-responders are re-randomized in stage 2. Efficacy analysis includes all data from stage 1 and all placebo non-responding subjects from stage 2. This article investigates the possibility to re-estimate the sample size and adjust the design parameters, allocation proportion to placebo in stage 1 of SPCD, and weight of stage 1 data in the overall efficacy test statistic during an interim analysis.

Effect of postnatal home visits on maternal/infant outcomes in Syria: a randomized controlled trial.

PubMed

Bashour, Hyam N; Kharouf, Mayada H; Abdulsalam, Asma A; El Asmar, Khalil; Tabbaa, Mohammed A; Cheikha, Salah A

2008-01-01

Early postpartum home visiting is universal in many Western countries. Studies from developing countries on the effects of home visits are rare. In Syria, where the postpartum period is rather ignored, this study aimed to assess whether a community-based intervention of postnatal home visits has an effect on maternal postpartum morbidities; infant morbidity; uptake of postpartum care; use of contraceptive methods; and on selected neonatal health practices. A randomized controlled trial was carried out in Damascus. Three groups of new mothers were randomly allocated to receive either 4 postnatal home visits (A), one visit (B), or no visit (C). A total of 876 women were allocated and followed up. Registered midwives with special training made a one or a series of home visits providing information, educating, and supporting women. A significantly higher proportion of mothers in Groups A and B reported exclusively breastfeeding their infants (28.5% and 30%, respectively) as compared with Group C (20%), who received no visits. There were no reported differences between groups in other outcomes. While postpartum home visits significantly increased exclusive breastfeeding, other outcomes did not change. Further studies framed in a nonbiomedical context are needed. Other innovative approaches to improve postnatal care in Syria are needed.

Does routine psychosocial screening improve referral to psychosocial care providers and patient-radiotherapist communication? A cluster randomized controlled trial.

PubMed

Braeken, Anna P B M; Lechner, Lilian; Eekers, Daniëlle B P; Houben, Ruud M A; van Gils, Francis C J M; Ambergen, Ton; Kempen, Gertrudis I J M

2013-11-01

This study tests whether using a screening instrument improves referral to psychosocial care providers (e.g. psychologist) and facilitates patient-radiotherapist communication. A cluster randomized controlled trial was used. Fourteen radiotherapists were randomly allocated to the experimental or control group and 568 of their patients received care in accordance with the group to which their radiotherapist was allocated. Patients in the experimental group were asked to complete a screening instrument before and at the end of the radiation treatment period. All patients were requested to complete questionnaires concerning patient-physician communication after the first consultation and concerning psychosocial care 3 and 12 months post-intervention. Patients who completed the screening instrument were referred to social workers at an earlier stage than patients who did not (P<0.01). No effects were observed for numbers of referred patients, or for improved patient-radiotherapist communication. Our results suggest that a simple screening procedure can be valuable for the timely treatment of psychosocial problems in patients. Future efforts should be directed at appropriate timing of screening and enhancing physicians' awareness regarding the importance of identifying, discussing and treating psychosocial problems in cancer patients. Psychosocial screening can be enhanced by effective radiotherapist-patient communication. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Effectiveness of cefoxitin on preventing endometritis after uterine curettage for spontaneous incomplete abortion: a randomized controlled trial study.

PubMed

Titapant, Vitaya; Cherdchoogieat, Panida

2012-11-01

There are only few studies concerning the usage of antibiotics in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion and no conclusion can be demonstrated To investigate the effectiveness of prophylactic cefoxitin in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion. Eighty-four women with spontaneous first trimester incomplete abortion were randomly allocated into two groups using a computer-generated random number list and the allocation concealment was maintained using a sealed opaque envelope. The patients in the study group were given 1 g of cefoxitin while the patients in the control group were given 0.1 ml of vitamin B complex intravenously 20 minutes prior to curettage. Uterine curettage was performed after intravenous sedation and analgesic drugs were administered. The patients were evaluated on the first, third and seventh day after uterine curettage. Seventy-nine cases had completed the study protocol. There were no statistically significant differences in demographic data and details of uterine curettage between both groups. Two cases of endometritis were found in the control group but none in the study group. However the difference did not reach the statistical significance (p = 0.241). Prophylactic cefoxitin is not effective in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion.

The Effect of Attributional Processes Concerning Medication Taking on Return of Fear

ERIC Educational Resources Information Center

Powers, Mark B.; Smits, Jasper A. J.; Whitley, Diana; Bystritsky, Alexander; Telch, Michael J.

2008-01-01

In this investigation, the authors examined the effect of attributional processes concerning medication taking on return of fear following exposure-based treatment. Participants (87% undergraduate students and 13% community volunteers) displaying marked claustrophobic fear (N = 95) were randomly allocated to a waitlist condition, a psychological…

Student Engagement with a Science Simulation: Aspects That Matter

ERIC Educational Resources Information Center

Rodrigues, Susan; Gvozdenko, Eugene

2011-01-01

It is argued that multimedia technology affords an opportunity to better visualise complex relationships often seen in chemistry. This paper describes the influence of chemistry simulation design facets on user progress through a simulation. Three versions of an acid-base titration simulation were randomly allocated to 36 volunteers to examine…

Effects of a Culture-Adaptive Forgiveness Intervention for Chinese College Students

ERIC Educational Resources Information Center

Ji, Mingxia; Hui, Eadaoin; Fu, Hong; Watkins, David; Tao, Linjin; Lo, Sing Kai

2016-01-01

The understanding and application of forgiveness varies across cultures. The current study aimed to examine the effect of a culture-adaptive Forgiveness Intervention on forgiveness attitude, self-esteem, empathy and anxiety of Mainland Chinese college students. Thirty-six participants were randomly allocated to either experimental groups or a…

Ethamsylate in vaginal surgery under lumbar epidural anaesthesia.

PubMed Central

Smith, G. B.; Eltringham, R. J.; Nightingale, J. J.

1983-01-01

Sixty patients scheduled for vaginal surgery under lumbar epidural block were randomly allocated into two groups, one of which received ethamsylate intravenously prior to induction of anaesthesia. Ethamsylate did not reduce the blood loss at operation in these patients. The possible factors underlying this observation are discussed. PMID:6338800

Using the Science Writing Heuristic to Improve Undergraduate Writing in Biology

ERIC Educational Resources Information Center

Cronje, Ruth; Murray, Kelly; Rohlinger, Spencer; Wellnitz, Todd

2013-01-01

Our objective was to investigate the impact of the Science Writing Heuristic (SWH) on undergraduates' ability to express logical conclusions and include appropriate evidence in formal writing assignments. Students in three laboratory sections were randomly allocated to the SWH treatment ("n"?=?51 students) with another three sections…

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...

Effects of the Case-Based Instruction Method on the Experience of Learning

ERIC Educational Resources Information Center

Amiri Farahani, Leila; Heidari, Tooba

2014-01-01

This semi-experimental study was conducted with twenty-seven midwifery students who were randomly allocated to either case-based instruction or lecture-based instruction groups. The selected subjects -- foetal intrapartum assessment, foetal antepartum assessment, ABO and Rh blood group system mismatch -- were presented in four ninety-minute…

The Efficacy of Stuttering Measurement Training: Evaluating Two Training Programs

ERIC Educational Resources Information Center

Bainbridge, Lauren A.; Stavros, Candace; Ebrahimian, Mineh; Wang, Yuedong; Ingham, Roger J.

2015-01-01

Purpose: Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Method: Four groups, each with 12 randomly allocated participants, completed a pretest-posttest design training study. They were evaluated by their counts of…

Grazing Soybean to Increase Voluntary Cow Traffic in a Pasture-based Automatic Milking System

PubMed Central

Clark, C. E. F.; Horadagoda, A.; Kerrisk, K. L.; Scott, V.; Islam, M. R.; Kaur, R.; Garcia, S. C.

2014-01-01

Pasture-based automatic milking systems (AMS) require cow traffic to enable cows to be milked. The interval between milkings can be manipulated by strategically allocating pasture. The current experiment investigated the effect of replacing an allocation of grazed pasture with grazed soybean (Glycine max) with the hypothesis that incorporating soybean would increase voluntary cow traffic and milk production. One hundred and eighty mixed age, primiparous and multiparous Holstein-Friesian/Illawarra cows were randomly assigned to two treatment groups (n = 90/group) with a 2×2 Latin square design. Each group was either offered treatments of kikuyu grass (Pennisetum clandestinum Hoach ex Chiov.) pasture (pasture) or soybean from 0900 h to 1500 h during the experimental period which consisted of 2 periods of 3 days following 5 days of training and adaptation in each period with groups crossing over treatments after the first period. The number of cows trafficking to each treatment was similar together with milk yield (mean ≈18 L/cow/d) in this experiment. For the cows that arrived at soybean or pasture there were significant differences in their behaviour and consequently the number of cows exiting each treatment paddock. There was greater cow traffic (more cows and sooner) exiting pasture allocations. Cows that arrived at soybean stayed on the allocation for 25% more time and ate more forage (8.5 kg/cow/d/allocation) relative to pasture (4.7 kg/cow/d/allocation). Pasture cows predominantly replaced eating time with rumination. These findings suggest that replacing pasture with alternative grazeable forages provides no additional incentive to increase voluntary cow traffic to an allocation of feed in AMS. This work highlights the opportunity to increase forage intakes in AMS through the incorporation of alternative forages. PMID:25049970

10-year trend in quantity and quality of pediatric randomized controlled trials published in mainland China: 2002–2011

PubMed Central

2013-01-01

Background Quality assessment of pediatric randomized controlled trials (RCTs) in China is limited. The aim of this study was to evaluate the quantitative trends and quality indicators of RCTs published in mainland China over a recent 10-year period. Methods We individually searched all 17 available pediatric journals published in China from January 1, 2002 to December 30, 2011 to identify RCTs of drug treatment in participants under the age of 18 years. The quality was evaluated according to the Cochrane quality assessment protocol. Results Of 1287 journal issues containing 44398 articles, a total of 2.4% (1077/44398) articles were included in the analysis. The proportion of RCTs increased from 0.28% in 2002 to 0.32% in 2011. Individual sample sizes ranged from 10 to 905 participants (median 81 participants); 2.3% of the RCTs were multiple center trials; 63.9% evaluated Western medicine, 32.5% evaluated traditional Chinese medicine; 15% used an adequate method of random sequence generation; and 10.4% used a quasi-random method for randomization. Only 1% of the RCTs reported adequate allocation concealment and 0.6% reported the method of blinding. The follow-up period was from 7 days to 96 months, with a median of 7.5 months. There was incomplete outcome data reported in 8.3%, of which 4.5% (4/89) used intention-to-treat analysis. Only 0.4% of the included trials used adequate random sequence allocation, concealment and blinding. The articles published from 2007 to 2011 revealed an improvement in the randomization method compared with articles published from 2002 to 2006 (from 2.7% to 23.6%, p = 0.000). Conclusions In mainland China, the quantity of RCTs did not increase in the pediatric population, and the general quality was relatively poor. Quality improvements were suboptimal in the later 5 years. PMID:23914882

Efficacy of tamoxifen and radiotherapy for prevention and treatment of gynaecomastia and breast pain caused by bicalutamide in prostate cancer: a randomised controlled trial.

PubMed

Perdonà, Sisto; Autorino, Riccardo; De Placido, Sabino; D'Armiento, Massimo; Gallo, Antonio; Damiano, Rocco; Pingitore, Domenico; Gallo, Luigi; De Sio, Marco; Bianco, Angelo Raffaele; Di Lorenzo, Giuseppe

2005-05-01

Gynaecomastia and breast pain are frequent adverse events with bicalutamide monotherapy, and might cause some patients to withdraw from treatment. We aimed to compare tamoxifen with radiotherapy for prevention and treatment of gynaecomastia, breast pain, or both during bicalutamide monotherapy for prostate cancer. 51 patients were randomly assigned to 150 mg bicalutamide per day, 50 patients to 150 mg bicalutamide per day and to 10 mg tamoxifen per day for 24 weeks, and 50 patients to 150 mg bicalutamide per day and radiotherapy (one 12-Gy fraction on the day of starting bicalutamide). 35 of the 51 patients allocated bicalutamide alone developed gynaecomastia or breast pain and were subsequently randomly allocated to tamoxifen (n=17) or radiotherapy (n=18) soon after symptoms started (median 180 days, range 160-195). Gynaecomastia and breast pain were assessed once a month. Severity of gynaecomastia was scored on the basis of the largest diameter. Breast pain was scored as none, mild, moderate, or severe. The primary outcome was frequency of gynaecomastia or breast pain; secondary outcomes were safety and tolerability, relapse-free survival, as assessed by concentration of prostate specific antigen, and quality of life. Analyses were by intention to treat. 35 of 51 patients assigned bicalutamide alone developed gynaecomastia, compared with four of 50 assigned bicalutamide and tamoxifen (odds ratio [OR] 0.1 [95% CI 0.08-0.12], p=0.0009), and with 17 of 50 assigned bicalutamide and radiotherapy (0.51 [0.47-0.54], p=0.008). Breast pain was seen in 29 of 51 patients allocated bicalutamide alone, compared with three allocated bicalutamide and tamoxifen (0.1 [0.07-0.11], p=0.009), and with 15 allocated bicalutamide and radiotherapy (0.43 [0.40-0.45], p=0.02) In 35 patients assigned bicalutamide alone who subsequently developed gynaecomastia, breast pain, or both, tamoxifen significantly reduced the frequency of gynaecomastia (0.2 [0.18-0.22], p=0.02). Antioestrogen treatment with tamoxifen could help patients with prostate cancer to tolerate the hypergonadotropic effects of bicalutamide monotherapy.

Bayesian dose selection design for a binary outcome using restricted response adaptive randomization.

PubMed

Meinzer, Caitlyn; Martin, Renee; Suarez, Jose I

2017-09-08

In phase II trials, the most efficacious dose is usually not known. Moreover, given limited resources, it is difficult to robustly identify a dose while also testing for a signal of efficacy that would support a phase III trial. Recent designs have sought to be more efficient by exploring multiple doses through the use of adaptive strategies. However, the added flexibility may potentially increase the risk of making incorrect assumptions and reduce the total amount of information available across the dose range as a function of imbalanced sample size. To balance these challenges, a novel placebo-controlled design is presented in which a restricted Bayesian response adaptive randomization (RAR) is used to allocate a majority of subjects to the optimal dose of active drug, defined as the dose with the lowest probability of poor outcome. However, the allocation between subjects who receive active drug or placebo is held constant to retain the maximum possible power for a hypothesis test of overall efficacy comparing the optimal dose to placebo. The design properties and optimization of the design are presented in the context of a phase II trial for subarachnoid hemorrhage. For a fixed total sample size, a trade-off exists between the ability to select the optimal dose and the probability of rejecting the null hypothesis. This relationship is modified by the allocation ratio between active and control subjects, the choice of RAR algorithm, and the number of subjects allocated to an initial fixed allocation period. While a responsive RAR algorithm improves the ability to select the correct dose, there is an increased risk of assigning more subjects to a worse arm as a function of ephemeral trends in the data. A subarachnoid treatment trial is used to illustrate how this design can be customized for specific objectives and available data. Bayesian adaptive designs are a flexible approach to addressing multiple questions surrounding the optimal dose for treatment efficacy within the context of limited resources. While the design is general enough to apply to many situations, future work is needed to address interim analyses and the incorporation of models for dose response.

Reporting of participant flow diagrams in published reports of randomized trials.

PubMed

Hopewell, Sally; Hirst, Allison; Collins, Gary S; Mallett, Sue; Yu, Ly-Mee; Altman, Douglas G

2011-12-05

Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented.

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation. Discussion This is the first trial investigating the effect of a set of integrated interventions to control both dengue and diarrhea. This is also the first trial to study the combination of diarrhea-dengue disease control in school settings. Trial registration Current Controlled Trials ISRCTN40195031 PMID:23034084

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial.

PubMed

Overgaard, Hans J; Alexander, Neal; Mátiz, Maria Ines; Jaramillo, Juan Felipe; Olano, Victor Alberto; Vargas, Sandra; Sarmiento, Diana; Lenhart, Audrey; Seidu, Razak; Stenström, Thor Axel

2012-10-03

Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation. This is the first trial investigating the effect of a set of integrated interventions to control both dengue and diarrhea. This is also the first trial to study the combination of diarrhea-dengue disease control in school settings. Current Controlled Trials ISRCTN40195031.

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization.

PubMed

Velthuis, Miranda J; May, Anne M; Monninkhof, Evelyn M; van der Wall, Elsken; Peeters, Petra H M

2012-03-01

Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information. We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation. The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group. We conclude that the alternatives were not better than conventional randomization. Copyright © 2012 Elsevier Inc. All rights reserved.

Datasets for supplier selection and order allocation with green criteria, all-unit quantity discounts and varying number of suppliers.

PubMed

Hamdan, Sadeque; Cheaitou, Ali

2017-08-01

This data article provides detailed optimization input and output datasets and optimization code for the published research work titled "Dynamic green supplier selection and order allocation with quantity discounts and varying supplier availability" (Hamdan and Cheaitou, 2017, In press) [1]. Researchers may use these datasets as a baseline for future comparison and extensive analysis of the green supplier selection and order allocation problem with all-unit quantity discount and varying number of suppliers. More particularly, the datasets presented in this article allow researchers to generate the exact optimization outputs obtained by the authors of Hamdan and Cheaitou (2017, In press) [1] using the provided optimization code and then to use them for comparison with the outputs of other techniques or methodologies such as heuristic approaches. Moreover, this article includes the randomly generated optimization input data and the related outputs that are used as input data for the statistical analysis presented in Hamdan and Cheaitou (2017 In press) [1] in which two different approaches for ranking potential suppliers are compared. This article also provides the time analysis data used in (Hamdan and Cheaitou (2017, In press) [1] to study the effect of the problem size on the computation time as well as an additional time analysis dataset. The input data for the time study are generated randomly, in which the problem size is changed, and then are used by the optimization problem to obtain the corresponding optimal outputs as well as the corresponding computation time.

Neuronal Allocation to a Hippocampal Engram

PubMed Central

Park, Sungmo; Kramer, Emily E; Mercaldo, Valentina; Rashid, Asim J; Insel, Nathan; Frankland, Paul W; Josselyn, Sheena A

2016-01-01

The dentate gyrus (DG) is important for encoding contextual memories, but little is known about how a population of DG neurons comes to encode and support a particular memory. One possibility is that recruitment into an engram depends on a neuron's excitability. Here, we manipulated excitability by overexpressing CREB in a random population of DG neurons and examined whether this biased their recruitment to an engram supporting a contextual fear memory. To directly assess whether neurons overexpressing CREB at the time of training became critical components of the engram, we examined memory expression while the activity of these neurons was silenced. Chemogenetically (hM4Di, an inhibitory DREADD receptor) or optogenetically (iC++, a light-activated chloride channel) silencing the small number of CREB-overexpressing DG neurons attenuated memory expression, whereas silencing a similar number of random neurons not overexpressing CREB at the time of training did not. As post-encoding reactivation of the activity patterns present during initial experience is thought to be important in memory consolidation, we investigated whether post-training silencing of neurons allocated to an engram disrupted subsequent memory expression. We found that silencing neurons 5 min (but not 24 h) following training disrupted memory expression. Together these results indicate that the rules of neuronal allocation to an engram originally described in the lateral amygdala are followed in different brain regions including DG, and moreover, that disrupting the post-training activity pattern of these neurons prevents memory consolidation. PMID:27187069

Neuronal Allocation to a Hippocampal Engram.

PubMed

Park, Sungmo; Kramer, Emily E; Mercaldo, Valentina; Rashid, Asim J; Insel, Nathan; Frankland, Paul W; Josselyn, Sheena A

2016-12-01

The dentate gyrus (DG) is important for encoding contextual memories, but little is known about how a population of DG neurons comes to encode and support a particular memory. One possibility is that recruitment into an engram depends on a neuron's excitability. Here, we manipulated excitability by overexpressing CREB in a random population of DG neurons and examined whether this biased their recruitment to an engram supporting a contextual fear memory. To directly assess whether neurons overexpressing CREB at the time of training became critical components of the engram, we examined memory expression while the activity of these neurons was silenced. Chemogenetically (hM4Di, an inhibitory DREADD receptor) or optogenetically (iC++, a light-activated chloride channel) silencing the small number of CREB-overexpressing DG neurons attenuated memory expression, whereas silencing a similar number of random neurons not overexpressing CREB at the time of training did not. As post-encoding reactivation of the activity patterns present during initial experience is thought to be important in memory consolidation, we investigated whether post-training silencing of neurons allocated to an engram disrupted subsequent memory expression. We found that silencing neurons 5 min (but not 24 h) following training disrupted memory expression. Together these results indicate that the rules of neuronal allocation to an engram originally described in the lateral amygdala are followed in different brain regions including DG, and moreover, that disrupting the post-training activity pattern of these neurons prevents memory consolidation.

Evaluating the statewide dissemination of smoking prevention curricula: factors in teacher compliance.

PubMed

Perry, C L; Murray, D M; Griffin, G

1990-12-01

As part of a larger study to evaluate the impact of a state-levied tax increase on tobacco products and the allocation of funds for smoking education, 81 schools were assigned randomly to one of four recommended smoking prevention programs for adolescents. The four programs differed in amount of program structure and extent of teacher training required. A one-session observation was made of 106 teachers in the 81 schools to assess the percentage of time allocated to recommended activities--those based on the social influences model. Data suggest an explicit curriculum with designed activities and face-to-face teacher training results in greater compliance to prescribed program components.

[The distribution of health resources: a hybrid model of equality and maximization].

PubMed

Farmer, Yanick

2012-01-01

In the allocation of resources for health care, it is generally acknowledged that models based exclusively either on efficiency and maximizing the cost/benefit ratio of interventions, or on equity and justice through the notion of "maximin," are unsatisfactory when taken separately. To fill this gap, this commentary suggests a hybrid model of resource allocation that integrates the idea of a random distribution of resources using a lottery. The general aim of this model is to safeguard the notions of justice and equal access to resources to the maximum extent possible in a climate where budget restrictions and the economic downturn may lead to future reductions in services.

Usefulness of Mendelian Randomization in Observational Epidemiology

PubMed Central

Bochud, Murielle; Rousson, Valentin

2010-01-01

Mendelian randomization refers to the random allocation of alleles at the time of gamete formation. In observational epidemiology, this refers to the use of genetic variants to estimate a causal effect between a modifiable risk factor and an outcome of interest. In this review, we recall the principles of a “Mendelian randomization” approach in observational epidemiology, which is based on the technique of instrumental variables; we provide simulations and an example based on real data to demonstrate its implications; we present the results of a systematic search on original articles having used this approach; and we discuss some limitations of this approach in view of what has been found so far. PMID:20616999

A person based formula for allocating commissioning funds to general practices in England: development of a statistical model.

PubMed

Dixon, Jennifer; Smith, Peter; Gravelle, Hugh; Martin, Steve; Bardsley, Martin; Rice, Nigel; Georghiou, Theo; Dusheiko, Mark; Billings, John; Lorenzo, Michael De; Sanderson, Colin

2011-11-22

To develop a formula for allocating resources for commissioning hospital care to all general practices in England based on the health needs of the people registered in each practice Multivariate prospective statistical models were developed in which routinely collected electronic information from 2005-6 and 2006-7 on individuals and the areas in which they lived was used to predict their costs of hospital care in the next year, 2007-8. Data on individuals included all diagnoses recorded at any inpatient admission. Models were developed on a random sample of 5 million people and validated on a second random sample of 5 million people and a third sample of 5 million people drawn from a random sample of practices. All general practices in England as of 1 April 2007. All NHS inpatient admissions and outpatient attendances for individuals registered with a general practice on that date. All individuals registered with a general practice in England at 1 April 2007. Power of the statistical models to predict the costs of the individual patient or each practice's registered population for 2007-8 tested with a range of metrics (R(2) reported here). Comparisons of predicted costs in 2007-8 with actual costs incurred in the same year were calculated by individual and by practice. Models including person level information (age, sex, and ICD-10 codes diagnostic recorded) and a range of area level information (such as socioeconomic deprivation and supply of health facilities) were most predictive of costs. After accounting for person level variables, area level variables added little explanatory power. The best models for resource allocation could predict upwards of 77% of the variation in costs at practice level, and about 12% at the person level. With these models, the predicted costs of about a third of practices would exceed or undershoot the actual costs by 10% or more. Smaller practices were more likely to be in these groups. A model was developed that performed well by international standards, and could be used for allocations to practices for commissioning. The best formulas, however, could predict only about 12% of the variation in next year's costs of most inpatient and outpatient NHS care for each individual. Person-based diagnostic data significantly added to the predictive power of the models.

Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

PubMed

Gudavalli, M Ram; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Corber, Lance; Patwardhan, Avinash G; Goertz, Christine M

2015-06-05

Manual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain. We conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions. We randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were documented. This pilot study demonstrated the feasibility of a clinical trial protocol and the utility of a traction-based, minimal intervention as an attention-touch control for future efficacy trials of MCD for patients with neck pain. ClinicalTrials.gov NCT01765751 (Registration Date 30 May 2012).

Atherogenic Lipoprotein Subfractions Determined by Ion Mobility and First Cardiovascular Events After Random Allocation to High-Intensity Statin or Placebo: The Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial.

PubMed

Mora, Samia; Caulfield, Michael P; Wohlgemuth, Jay; Chen, Zhihong; Superko, H Robert; Rowland, Charles M; Glynn, Robert J; Ridker, Paul M; Krauss, Ronald M

2015-12-08

Cardiovascular disease (CVD) can occur in individuals with low low-density lipoprotein (LDL) cholesterol (LDL-C). We investigated whether detailed measures of LDL subfractions and other lipoproteins can be used to assess CVD risk in a population with both low LDL-C and high C-reactive protein who were randomized to high-intensity statin or placebo. In 11 186 Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) participants, we tested whether lipids, apolipoproteins, and ion mobility-measured particle concentrations at baseline and after random allocation to rosuvastatin 20 mg/d or placebo were associated with first CVD events (n=307) or CVD/all-cause death (n=522). In placebo-allocated participants, baseline LDL-C was not associated with CVD (adjusted hazard ratio [HR] per SD, 1.03; 95% confidence interval [CI], 0.88-1.21). In contrast, associations with CVD events were observed for baseline non-high-density lipoprotein (HDL) cholesterol (HR, 1.18; 95% CI, 1.01-1.38), apolipoprotein B (HR, 1.28; 95% CI, 1.11-1.48), and ion mobility-measured non-HDL particles (HR, 1.19; 95% CI, 1.05-1.35) and LDL particles (HR, 1.21; 95% CI, 1.07-1.37). Association with CVD events was also observed for several LDL and very-low-density lipoprotein subfractions but not for ion mobility-measured HDL subfractions. In statin-allocated participants, CVD events were associated with on-treatment LDL-C, non-HDL cholesterol, and apolipoprotein B; these were also associated with CVD/all-cause death, as were several LDL and very-low-density lipoprotein subfractions, albeit with a pattern of association that differed from the baseline risk. In JUPITER, baseline LDL-C was not associated with CVD events, in contrast with significant associations for non-HDL cholesterol and atherogenic particles: apolipoprotein B and ion mobility-measured non-HDL particles, LDL particles, and select subfractions of very-low-density lipoprotein particles and LDL particles. During high-intensity statin therapy, on-treatment levels of LDL-C and atherogenic particles were associated with residual risk of CVD/all-cause death. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00239681. © 2015 American Heart Association, Inc.

Evaluation of Preparatory Measures for Coping with Anxiety Raised by Media Coverage of Terrorism

ERIC Educational Resources Information Center

Slone, Michelle; Shoshani, Anat

2006-01-01

This study examines effects of television broadcasts of terrorism on viewers' anxiety and raises suggestions for 2 intervention strategies to moderate elevated anxiety. Participants were 120 young Israeli adults randomly allocated to a terrorism or a nonterrorism television broadcast and assigned to 1 of 3 intervention conditions prior to…

Using Chemistry Simulations: Attention Capture, Selective Amnesia and Inattentional Blindness

ERIC Educational Resources Information Center

Rodrigues, Susan

2011-01-01

Twenty-one convenience sample student volunteers aged between 14-15 years worked in pairs (and one group of three) with two randomly allocated high quality conceptual (molecular level) and operational (mimicking wet labs) simulations. The volunteers were told they had five minutes to play, repeat, review, restart or stop the simulation, which in…

Computer-Assisted Intervention for Children with Low Numeracy Skills

ERIC Educational Resources Information Center

Rasanen, Pekka; Salminen, Jonna; Wilson, Anna J.; Aunio, Pirjo; Dehaene, Stanislas

2009-01-01

We present results of a computer-assisted intervention (CAI) study on number skills in kindergarten children. Children with low numeracy skill (n = 30) were randomly allocated to two treatment groups. The first group played a computer game (The Number Race) which emphasized numerical comparison and was designed to train number sense, while the…

Information needs for increasing log transport efficiency

Treesearch

Timothy P. McDonald; Steven E. Taylor; Robert B. Rummer; Jorge Valenzuela

2001-01-01

Three methods of dispatching trucks to loggers were tested using a log transport simulation model: random allocation, fixed assignment of trucks to loggers, and dispatch based on knowledge of the current status of trucks and loggers within the system. This 'informed' dispatch algorithm attempted to minimize the difference in time between when a logger would...

Testing the Efficacy of Theoretically Derived Improvements in the Treatment of Social Phobia

ERIC Educational Resources Information Center

Rapee, Ronald M.; Gaston, Jonathan E.; Abbott, Maree J.

2009-01-01

Recent theoretical models of social phobia suggest that targeting several specific cognitive factors in treatment should enhance treatment efficacy over that of more traditional skills-based treatment programs. In the current study, 195 people with social phobia were randomly allocated to 1 of 3 treatments: standard cognitive restructuring plus in…

Reading Intervention for Poor Readers at the Transition to Secondary School

ERIC Educational Resources Information Center

Clarke, Paula J.; Paul, Shirley-Anne S.; Smith, Glynnis; Snowling, Margaret J.; Hulme, Charles

2017-01-01

This study evaluated two 20-week reading interventions for pupils entering secondary school with reading difficulties. The interventions were delivered by trained teaching assistants (three 35-min sessions per week). 287 pupils (ages 11-13) from 27 schools were randomly allocated to three groups: reading intervention (targeting word recognition…

The Impact of Institutional Grant Aid on College Choice

ERIC Educational Resources Information Center

Hurwitz, Michael

2012-01-01

In this study, I exploit exogenous differences in institutional policies regarding the treatment of home equity in grant aid allocation to estimate a causal impact of institutional grant aid on college choice. Because institutional grant aid is typically not awarded randomly, the college-estimated home equity value serves as an instrumental…

First Year Effects of Induction Arrangements on Beginning Teachers' Psychological Processes

ERIC Educational Resources Information Center

Helms-Lorenz, Michelle; Slof, Bert; van de Grift, Wim

2013-01-01

This study examined the (1) effects of a supportive program (i.e., induction arrangement) on beginning teachers' (BTs') psychological processes after a period of 1 year and (2) psychological paths of influence of the arrangement. Participants (56 Dutch secondary schools with 143 BTs) were randomly allocated to two conditions. Experimental schools…

Effects of spatial allocation and parameter variability on lakewide estimates from surveys of Lake Superior, North America’s largest lake

EPA Science Inventory

Lake Superior was sampled in 2011 using a Generalized Random Tessellation Stratified design (n=54 sites) to characterize biological and chemical properties of this huge aquatic resource, with statistical confidence. The lake was divided into two strata (inshore <100m and offsh...

13 CFR 123.410 - Which loan requests will SBA fund?

Code of Federal Regulations, 2012 CFR

2012-01-01

... each application (loan request) as it is received. SBA will fund loan requests which meet the selection... allocated all available program funds. Multiple applications received on the same day will be ranked by a computer based random selection system to determine their funding order. SBA will notify you in writing of...

13 CFR 123.410 - Which loan requests will SBA fund?

Code of Federal Regulations, 2013 CFR

2013-01-01

... each application (loan request) as it is received. SBA will fund loan requests which meet the selection... allocated all available program funds. Multiple applications received on the same day will be ranked by a computer based random selection system to determine their funding order. SBA will notify you in writing of...

13 CFR 123.410 - Which loan requests will SBA fund?

Code of Federal Regulations, 2014 CFR

2014-01-01

... each application (loan request) as it is received. SBA will fund loan requests which meet the selection... allocated all available program funds. Multiple applications received on the same day will be ranked by a computer based random selection system to determine their funding order. SBA will notify you in writing of...

Impact of an Educational Intervention on Breast Cancer Knowledge in Western Kenya

ERIC Educational Resources Information Center

Kisuya, J.; Wachira, J.; Busakhala, N.; Naanyu, V.; Chite, A. F.; Omenge, O.; Otieno, G.; Keter, A.; Mwangi, A.; Inui, T.

2015-01-01

Our objective was to assess the effectiveness of educational sessions that accompanied breast cancer screening events in three communities in western Kenya between October and November 2013. Five hundred and thirty-two women were recruited to complete a test of breast cancer-relevant knowledge and randomly allocated to "pre-test" or…

A Randomised Efficacy Study of Web-Based Synthetic and Analytic Programmes among Disadvantaged Urban Kindergarten Children

ERIC Educational Resources Information Center

Comaskey, Erin M.; Savage, Robert S.; Abrami, Philip

2009-01-01

This study explores whether two computer-based literacy interventions--a "synthetic phonics" and an "analytic phonics" approach produce qualitatively distinct effects on the early phonological abilities and reading skills of disadvantaged urban Kindergarten (Reception) children. Participants (n=53) were assigned by random allocation to one of the…

Randomly biased investments and the evolution of public goods on interdependent networks

NASA Astrophysics Data System (ADS)

Chen, Wei; Wu, Te; Li, Zhiwu; Wang, Long

2017-08-01

Deciding how to allocate resources between interdependent systems is significant to optimize efficiency. We study the effects of heterogeneous contribution, induced by such interdependency, on the evolution of cooperation, through implementing the public goods games on two-layer networks. The corresponding players on different layers try to share a fixed amount of resources as the initial investment properly. The symmetry breaking of investments between players located on different layers is able to either prevent investments from, or extract them out of the deadlock. Results show that a moderate investment heterogeneity is best favorable for the evolution of cooperation, and random allocation of investment bias suppresses the cooperators at a wide range of the investment bias and the enhancement effect. Further studies on time evolution with different initial strategy configurations show that the non-interdependent cooperators along the interface of interdependent cooperators also are an indispensable factor in facilitating cooperative behavior. Our main results are qualitatively unchanged even diversifying investment bias that is subject to uniform distribution. Our study may shed light on the understanding of the origin of cooperative behavior on interdependent networks.

Social support influences preferences for feminine facial cues in potential social partners.

PubMed

Watkins, Christopher D; DeBruine, Lisa M; Little, Anthony C; Jones, Benedict C

2012-01-01

Most previous studies of individual differences in women's and men's preferences for sexually dimorphic physical characteristics have focused on the importance of mating-related factors for judgments of opposite-sex individuals. Although studies have suggested that people may show stronger preferences for feminine individuals of both sexes under conditions where social support may be at a premium (e.g., during phases of the menstrual cycle where raised progesterone prepares women's bodies for pregnancy), these studies have not demonstrated that perceptions of available social support directly influence femininity preferences. Here we found that (1) women and men randomly allocated to low social support priming conditions demonstrated stronger preferences for feminine shape cues in own- and opposite-sex faces than did individuals randomly allocated to high social support priming conditions and (2) that people perceived men and women displaying feminine characteristics as more likely to provide them with high-quality social support than those displaying relatively masculine characteristics. Together, these findings suggest that social support influences face preferences directly, potentially implicating facultative responses whereby people increase their preferences for pro-social individuals under conditions of low social support.

A randomised group comparison controlled trial of 'preschoolers with autism': a parent education and skills training intervention for young children with autistic disorder.

PubMed

Tonge, Bruce; Brereton, Avril; Kiomall, Melissa; Mackinnon, Andrew; Rinehart, Nicole J

2014-02-01

To determine the effect of parent education on adaptive behaviour, autism symptoms and cognitive/language skills of young children with autistic disorder. A randomised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample. Two rural and two metropolitan regions were randomly allocated to intervention groups (n = 70) or control (n = 35). Parents from autism assessment services in the intervention regions were randomly allocated to parent education and behaviour management (n = 35) or parent education and counselling (n = 35). Parent education and behaviour management resulted in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour. Parent education and behaviour management was superior to parent education and counselling. We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children.

Double jeopardy, the equal value of lives and the veil of ignorance: a rejoinder to Harris.

PubMed

McKie, J; Kuhse, H; Richardson, J; Singer, P

1996-08-01

Harris levels two main criticisms against our original defence of QALYs (Quality Adjusted Life Years). First, he rejects the assumption implicit in the QALY approach that not all lives are of equal value. Second, he rejects our appeal to Rawls's veil of ignorance test in support of the QALY method. In the present article we defend QALYs against Harris's criticisms. We argue that some of the conclusions Harris draws from our view that resources should be allocated on the basis of potential improvements in quality of life and quantity of life are erroneous, and that others lack the moral implications Harris claims for them. On the other hand, we defend our claim that a rational egoist, behind a veil of ignorance, could consistently choose to allocate life-saving resources in accordance with the QALY method, despite Harris's claim that a rational egoist would allocate randomly if there is no better than a 50% chance of being the recipient.

Double jeopardy, the equal value of lives and the veil of ignorance: a rejoinder to Harris.

PubMed Central

McKie, J; Kuhse, H; Richardson, J; Singer, P

1996-01-01

Harris levels two main criticisms against our original defence of QALYs (Quality Adjusted Life Years). First, he rejects the assumption implicit in the QALY approach that not all lives are of equal value. Second, he rejects our appeal to Rawls's veil of ignorance test in support of the QALY method. In the present article we defend QALYs against Harris's criticisms. We argue that some of the conclusions Harris draws from our view that resources should be allocated on the basis of potential improvements in quality of life and quantity of life are erroneous, and that others lack the moral implications Harris claims for them. On the other hand, we defend our claim that a rational egoist, behind a veil of ignorance, could consistently choose to allocate life-saving resources in accordance with the QALY method, despite Harris's claim that a rational egoist would allocate randomly if there is no better than a 50% chance of being the recipient. PMID:8863144

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955–2013

PubMed Central

Armijo-Olivo, Susan; Cummings, Greta G.; Amin, Maryam; Flores-Mir, Carlos

2017-01-01

Objectives To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. Methods We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Results Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955–2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. Conclusions The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed. PMID:29272315

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

PubMed

Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

2017-01-01

To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955-2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed.

A randomized clinical trial of a financial education intervention with nicotine replacement therapy (NRT) for low socio-economic status Australian smokers: a study protocol.

PubMed

Courtney, Ryan J; Bradford, Deborah; Martire, Kristy A; Bonevski, Billie; Borland, Ron; Doran, Christopher; Hall, Wayne; Farrell, Michael; Siahpush, Mohammad; Sanson-Fisher, Rob; West, Robert; Mattick, Richard P

2014-10-01

Reducing smoking prevalence among smokers from low socio-economic status (SES) is a preventative health priority. Financial stress (e.g. shortage of money or inability to pay bills) may be a major barrier to quitting smoking. This study evaluates the efficacy of a financial education and support programme coupled with pharmacotherapy at improving cessation rates at 8-month follow-up among Australian low SES smokers (people receiving a government pension or allowance). A two-group parallel block randomized (ratio 1 : 1) open-label clinical trial (RCT) with allocation concealment will be conducted. Allocation will be concealed to interviewers at data collection-points. The study will be conducted primarily by telephone with baseline, follow-up interviews and telephone-based support sessions. Nicotine replacement therapy (NRT) delivery will be mail-based. Daily smokers who are interested in quitting smoking and are currently in receipt of government benefits (n = 1046) will be recruited through study advertisements placed in newspapers, posters placed in government social assistance agencies and Quitline telephone-based cessation support services. After completion of a baseline computer-assisted telephone interview, participants will be allocated randomly to control or intervention group using a permuted block approach. Participants in both groups will receive 8 weeks of free combination NRT plus Quitline support. Participants in the intervention group will also receive four telephone-delivered financial education and support sessions. The primary outcome measure will be prolonged abstinence (at 8-month follow-up) assessed using Russell Standard criteria and biochemically verified (urine cotinine). This is the first intervention study to evaluate the potential of co-managing financial stress as a means of enhancing smokers' capacity to quit smoking. Such an intervention may provide a scalable intervention to help low SES smokers to quit. © 2014 Society for the Study of Addiction.

Effects of preoperative aspirin in coronary artery bypass grafting: a double-blind, placebo-controlled, randomized trial.

PubMed

Deja, Marek A; Kargul, Tomasz; Domaradzki, Wojciech; Stącel, Tomasz; Mazur, Witold; Wojakowski, Wojciech; Gocoł, Radosław; Gaszewska-Żurek, Ewa; Żurek, Paweł; Pytel, Agata; Woś, Stanisław

2012-07-01

This trial was undertaken to determine the safety and efficacy of preoperative aspirin administration in a contemporary cardiac surgical practice setting. This randomized, double-blind, parallel-group, single-center trial involved patients with stable coronary artery disease who were assigned to receive either 300 mg of aspirin or placebo the night before coronary bypass surgery. Using a random digit table, patients were allocated to receive the tablet from 1 of the 40 coded bottles containing either aspirin or placebo. Patients, surgeons, anesthetists, and investigators were all masked to treatment allocation. The primary safety end points were as follows: more than 750 mL of bleeding during the first postoperative 12 hours and more than 1000 mL of total discharge from the chest drains. The secondary efficacy end point was a composite of cardiovascular death, myocardial infarction, or repeat revascularization. A total of 390 patients were allocated to aspirin (387 analyzed) and 399 to placebo (396 analyzed). The follow-up median was 53 months. Fifty-four placebo recipients and 86 aspirin recipients bled more than 750 mL in the first 12 hours (odds ratio [OR], 1.81; 95% confidence interval [CI], 1.25-2.63), while total chest drain discharge was above 1000 mL in 96 placebo and 131 aspirin recipients (OR, 1.60; 95% CI, 1.17-2.18). Preoperative aspirin decreased the long-term hazard of nonfatal coronary event (infarction or repeat revascularization)-hazard ratio (HR), 0.58 (95% CI, 0.33-0.99)--and tended to decrease the hazard of a major cardiac event (cardiovascular death, infarction, or repeat revascularization--HR, 0.65 [95% CI, 0.41-1.03]). Performing coronary grafts on aspirin is associated with increased postoperative bleeding but may decrease the long-term hazard of coronary events. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol

PubMed Central

2012-01-01

Background Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. Methods/design An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). Discussion If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. Trial registration The study is registered as NCT01291953 (ClinicalTrials.gob) PMID:23130754

Allocating forage to fall-calving cow-calf pairs strip-grazing stockpiled tall fescue.

PubMed

Curtis, L E; Kallenbach, R L; Roberts, C A

2008-03-01

In a 2-yr study, we evaluated the effect of different forage allocations on the performance of lactating beef cows and their calves grazing stockpiled tall fescue. Allocations of stockpiled tall fescue at 2.25, 3.00, 3.75, and 4.50% of cow-calf pair BW/d were set as experimental treatments. Conventional hay-feeding was also evaluated as a comparison to grazing stockpiled tall fescue. The experiment had a randomized complete block design with 3 replications and was divided into 3 phases each year. From early December to late February (phase 1) of each year, cows and calves grazed stockpiled tall fescue or were fed hay in the treatments described above. Immediately after phase 1, cows and calves were commingled and managed as a single group until weaning in April (phase 2) so that residual effects could be documented. Residual effects on cows were measured after the calves were weaned in April until mid-July (phase 3). During phase 1 of both years, apparent DMI of cow-calf pairs allocated stockpiled tall fescue at 4.50% of BW/d was 31% greater (P < 0.01) than those allocated 2.25% of BW/d. As allocation of stockpiled tall fescue increased from 2.25 to 4.50% of cow-calf BW/d, pasture utilization fell (P < 0.01) from 84 +/- 7% to 59 +/- 7%. During phase 1 of both years, cow BW losses increased linearly (P < 0.02) as forage allocations decreased, although the losses in yr 1 were almost double (P < 0.01) those in yr 2. During phases 2 and 3, few differences were noted across treatment groups, such that by the end of phase 3, cow BW in all treatments did not differ either year (P > 0.40). Calf ADG in phase 1 increased linearly (P < 0.01) with forage allocation (y = 0.063x + 0.513; R(2) = 0.91). However, calf gain per hectare decreased linearly (P < 0.01) as stockpiled tall fescue allocations increased (y = -26.5x + 212; R(2) = 0.97) such that gain per hectare for cow-calf pairs allocated stockpiled tall fescue at 4.50% BW/d was nearly 40% less (P < 0.01) than for those allocated 2.25% of BW/d. Allocating cow-calf pairs stockpiled tall fescue at 2.25% of BW/d likely optimizes its use; because cow body condition is easily regained in the subsequent spring and summer months, less forage is used during winter, and calf gain per hectare is maximized.

Priority setting and the ethics of resource allocation within VA healthcare facilities: results of a survey.

PubMed

Foglia, Mary Beth; Pearlman, Robert A; Bottrell, Melissa M; Altemose, Jane A; Fox, Ellen

2008-01-01

Setting priorities and the subsequent allocation of resources is a major ethical issue facing healthcare facilities, including the Veterans Health Administration (VHA), the largest integrated healthcare delivery network in the United States. Yet despite the importance of priority setting and its impact on those who receive and those who provide care, we know relatively little about how clinicians and managers view allocation processes within their facilities. The purpose of this secondary analysis of survey data was to characterize staff members' perceptions regarding the fairness of healthcare ethics practices related to resource allocation in Veterans Administration (VA) facilities. The specific aim of the study was to compare the responses of clinicians, clinician managers, and non-clinician managers with respect to these survey items. We utilized a paper and web-based survey and a cross-sectional design of VHA clinicians and managers. Our sample consisted of a purposive stratified sample of 109 managers and a stratified random sample of 269 clinicians employed 20 or more hours per week in one of four VA medical centers. The four medical centers were participating as field sites selected to test the logistics of administering and reporting results of the Integrated Ethics Staff Survey, an assessment tool aimed at characterizing a broad range of ethical practices within a healthcare organization. In general, clinicians were more critical than clinician managers or non-clinician managers of the institutions' allocation processes and of the impact of resource decisions on patient care. Clinicians commonly reported that they did not (a) understand their facility's decision-making processes, (b) receive explanations from management regarding the reasons behind important allocation decisions, or (b) perceive that they were influential in allocation decisions. In addition, clinicians and managers both perceived that education related to the ethics of resource allocation was insufficient and that their facilities could increase their effectiveness in identifying and resolving ethical problems related to resource allocation. How well a healthcare facility ensures fairness in the way it allocates its resources across programs and services depends on multiple factors, including awareness by decision makers that setting priorities and allocating resources is a moral enterprise (moral awareness), the availability of a consistent process that includes important stakeholder groups (procedural justice), and concurrence by stakeholders that decisions represent outcomes that fairly balance competing interests and have a positive net effect on the quality of care (distributive justice). In this study, clinicians and managers alike identified the need for improvement in healthcare ethics practices related to resource allocation.

The effects of motivation feedback in patients with severe mental illness: a cluster randomized controlled trial

PubMed Central

Jochems, Eline C; van der Feltz-Cornelis, Christina M; van Dam, Arno; Duivenvoorden, Hugo J; Mulder, Cornelis L

2015-01-01

Objective To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness. Methods Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968). Participants: adult outpatients with a primary diagnosis of a psychotic disorder or a personality disorder and their clinicians, treated in 12 community mental health teams (the clusters) of two mental health institutions in the Netherlands. Interventions: monthly motivation feedback (MF) generated by clinicians additional to treatment as usual (TAU) and TAU by the community mental health teams. Primary outcome: treatment engagement at patient level, assessed at 12 months by clinicians. Randomization: teams were allocated to MF or TAU by a computerized randomization program that randomized each team to a single treatment by blocks of varying size. All participants within these teams received similar treatment. Clinicians and patients were not blind to treatment allocation at the 12-month assessment. Results The 294 randomized patients (148 MF, 146 TAU) and 57 clinicians (29 MF, 28 TAU) of 12 teams (6 MF, 6 TAU) were analyzed according to the intention-to-treat principle. No statistically significant differences between treatment groups on treatment engagement were found (adjusted mean difference =0.1, 95% confidence interval =−2.2 to 2.3, P=0.96, d=0). Preplanned ancillary analyses showed statistically significant interaction effects between treatment group and primary diagnosis on treatment motivation and quality of life (secondary outcomes), which were beneficial for patients with a primary diagnosis of a personality disorder but not for those with a psychotic disorder. There were no reports of adverse events. Conclusion The current findings imply that monitoring and discussing the patient’s motivation is insufficient to improve motivation and treatment engagement, and suggests that more elaborate interventions for severe mental illness patients are needed. PMID:26715847

Prediction of motivational impairment: 12-month follow-up of the randomized-controlled trial on extended early intervention for first-episode psychosis.

PubMed

Chang, W C; Kwong, V W Y; Chan, G H K; Jim, O T T; Lau, E S K; Hui, C L M; Chan, S K W; Lee, E H M; Chen, E Y H

2017-03-01

Amotivation is prevalent in first-episode psychosis (FEP) patients and is a major determinant of functional outcome. Prediction of amotivation in the early stage of psychosis, however, is under-studied. We aimed to prospectively examine predictors of amotivation in FEP patients in a randomized-controlled trial comparing a 1-year extension of early intervention (Extended EI, 3-year EI) with step-down psychiatric care (SC, 2-year EI). One hundred sixty Chinese patents were recruited from a specialized EI program for FEP in Hong Kong after they have completed this 2-year EI service, randomly allocated to Extended EI or SC, and followed up for 12 months. Assessments on premorbid adjustment, onset profiles, baseline symptom severity and treatment characteristics were conducted. Data analysis was based on 156 subjects who completed follow-up assessments. Amotivation at 12-month follow-up was associated with premorbid adjustment, allocated treatment condition, and levels of positive symptoms, disorganization, amotivation, diminished expression (DE) and depression at study intake. Hierarchical multiple regression analysis revealed that Extended EI and lower levels of DE independently predicted better outcome on 12-month amotivation. Our findings indicate a potentially critical therapeutic role of an extended specialized EI on alleviating motivational impairment in FEP patients. The longer-term effect of Extended EI on amotivation merits further investigation. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Transcutaneous bilirubinometry reduces the need for blood sampling in neonates with visible jaundice.

PubMed

Mishra, S; Chawla, D; Agarwal, R; Deorari, A K; Paul, V K; Bhutani, V K

2009-12-01

We determined usefulness of transcutaneous bilirubinometry to decrease the need for blood sampling to assay serum total bilirubin (STB) in the management of jaundiced healthy Indian neonates. Newborns, > or =35 weeks' gestation, with clinical evidence of jaundice were enrolled in an institutional approved randomized clinical trial. The severity of hyperbilirubinaemia was determined by two non-invasive methods: i) protocol-based visual assessment of bilirubin (VaB) and ii) transcutaneous bilirubin (TcB) determination (BiliCheck). By a random allocation, either method was used to decide the need for blood sampling, which was defined to be present if assessed STB by allocated method exceeded 80% of hour-specific threshold values for phototherapy (2004 AAP Guidelines). A total of 617 neonates were randomized to either TcB (n = 314) or VaB (n = 303) groups with comparable gestation, birth weight and postnatal age. Need for blood sampling to assay STB was 34% lower (95% CI: 10% to 51%) in the TcB group compared with VaB group (17.5% vs 26.4% assessments; risk difference: -8.9%, 95% CI: -2.4% to -15.4%; p = 0.008). Routine use of transcutaneous bilirubinometry compared with systematic visual assessment of bilirubin significantly reduced the need for blood sampling to assay STB in jaundiced term and late-preterm neonates. (ClinicalTrials.gov number, NCT00653874).

Trends in the application of dynamic allocation methods in multi-arm cancer clinical trials.

PubMed

Pond, Gregory R; Tang, Patricia A; Welch, Stephen A; Chen, Eric X

2010-06-01

Dynamic allocation (DA) methods which attempt to balance baseline prognostic factors between treatment arms, can be used in multi-arm clinical trials to sequentially allocate patients to treatment. Although some experts express concern regarding the validity of inference from trials using DA, others believe DA methods produce more credible results. A review of published multi-arm cancer clinical trials was conducted to explore the frequency of DA use in oncology. Multi-arm phase III clinical trials of at least 100 patients per arm, published in 13 major oncology journals from 1995-2005 were manually reviewed. Information about reported use of DA methods, or randomization via random permuted blocks (PB), was extracted along with trial characteristics. Of 476 published clinical trials, 112 (23.5%) reported using some form of DA method, while 103 (21.6%) reported using PB methods. Most trials (403 or 84.7%) reported stratifying on at least one baseline factor. The mean number of stratification factors was 2.70 per trial, and 78.6% of DA trials reported 3 or more stratification factors compared with 30.2% of non-DA trials (p < 0.001). The frequency of DA use increased over time, with 20.2%, 21.3%, 25.8%, 28.8% and 38.9% of trials reported use in 1995-2001, 2002, 2003, 2004, and 2005, respectively. Use of DA methods was more frequently reported in trials involving an academic co-operative group (28.4% vs. 13.8%), however, no difference was observed between industry-funded and other-funded trials (24.0% vs. 23.2%) or geographical region (19.7% of North American trials, 26.2% of European trials and 21.7% of multinational/other trials). As a retrospective analysis, the true frequency of DA use is likely underreported. Few trials gave complete details of the allocation method used, thus it is possible some manuscripts reported incorrect allocation methods. Journals were selected which were assumed to publish most large, multi-arm clinical trials in cancer from 1995-2005, however, some trials were likely reported in journals other than what was reviewed. DA methods are frequently used in multi-arm cancer clinical trials. The use of DA appears to becoming more common over time and are used more frequently when an academic cooperative group is involved. No relationship between industry funded trials or geographic region and allocation method was observed. Clinical Trials 2010; 7: 227-234. http://ctj.sagepub.com.

The Therapeutic Alliance in Schema-Focused Therapy and Transference-Focused Psychotherapy for Borderline Personality Disorder

ERIC Educational Resources Information Center

Spinhoven, Philip; Giesen-Bloo, Josephine; van Dyck, Richard; Kooiman, Kees; Arntz, Arnoud

2007-01-01

This study investigated the quality and development of the therapeutic alliance as a mediator of change in schema-focused therapy (SFT) and transference-focused psychotherapy (TFP) for borderline personality disorder. Seventy-eight patients were randomly allocated to 3 years of biweekly SFT or TFP. Scores of both therapists and patients for the…

Reducing Problem Behavior during Care-Giving in Families of Preschool-Aged Children with Developmental Disabilities

ERIC Educational Resources Information Center

Plant, Karen M.; Sanders, Matthew R.

2007-01-01

This study evaluated two variants of a behavioral parent training program known as Stepping Stones Triple P (SSTP) using 74 preschool-aged children with developmental disabilities. Families were randomly allocated to an enhanced parent training intervention that combined parenting skills and care-giving coping skills (SSTP-E), standard parent…

Performance by Fall-Calving Cows Grazing Tall Fescue Pastures With Different Proportions Stockpiled

USDA-ARS?s Scientific Manuscript database

Tall fescue [Lolium arundinaceum (Schreb.) S.J. Darbyshire.] is often stockpiled to reduce winter feed costs for cattle. Over two consecutive years, a total of 158 Gelbvieh × Angus fall-calving cows (1318 plus/minus 13.2 lb) were allocated randomly to one of eight 24-acre tall fescue pastures on 18 ...

Performance by Fall-Calving Cows Grazing Tall Fescue Pastures with Different Proportions Stockpiled

USDA-ARS?s Scientific Manuscript database

Tall fescue [Lolium arundinaceum (Schreb.) Darbysh.] is often stockpiled to reduce winter feed costs for cattle. Over two consecutive years, a total of 158 Gelbvieh × Angus fall-calving cows (599 ± 6.0 kg) were allocated randomly to one of eight 10-ha tall fescue pastures (subdivided into six 1.6-h...

Improving Ascertainment of Risk Factors for HIV Infection: Results of a Group-Randomized Evaluation

ERIC Educational Resources Information Center

Harrison, Kathleen McDavid; Pals, Sherri L.; Sajak, Tammy; Chase, Jennifer; Kajese, Tebitha

2010-01-01

To allow appropriate allocation of prevention and care funding, HIV/AIDS surveillance data must include risk factor information, currently available for less than 70% of cases reported in the United States. The authors evaluated an intervention consisting of provider training and materials to improve risk factor reporting. Facilities were matched…

Cognitive-Behavioral Therapy versus Temporal Pulse Amplitude Biofeedback Training for Recurrent Headache

ERIC Educational Resources Information Center

Martin, Paul R.; Forsyth, Michael R.; Reece, John

2007-01-01

Sixty-four headache sufferers were allocated randomly to cognitive-behavioral therapy (CBT), temporal pulse amplitude (TPA) biofeedback training, or waiting-list control. Fifty-one participants (14M/37F) completed the study, 30 with migraine and 21 with tension-type headache. Treatment consisted of 8, 1-hour sessions. CBT was highly effective,…

Mindfulness-Based Cognitive Therapy: Further Issues in Current Evidence and Future Research

ERIC Educational Resources Information Center

Williams, J. Mark G.; Russell, Ian; Russell, Daphne

2008-01-01

The authors respond to the article by H. F. Coelho, P. H. Canter, and E. Ernst (2007), which reviewed the current status of mindfulness-based cognitive therapy (MBCT). First, they clarify the randomization procedures in the 2 main MBCT trials. Second, they report posttreatment and follow-up data to show that trial participants allocated to…

The Evolution of the School-Entry Age Effect in a School Tracking System

ERIC Educational Resources Information Center

Muhlenweg, Andrea M.; Puhani, Patrick A.

2010-01-01

In Germany, students are streamed at age ten into an academic or nonacademic track. We demonstrate that the randomly allocated disadvantage of being born just before as opposed to just after the cutoff date for school entry leads to substantially different schooling experiences. Relatively young students are initially only two-thirds as likely to…

Effect of aspirin treatment on chondromalacia patellae.

PubMed Central

Bentley, G; Leslie, I J; Fischer, D

1981-01-01

Twenty-nine patients (21 females and 8 males) with chondromalacia patellae diagnosed by arthroscopy were randomly allocated to receive aspirin or placebo for 3 months. Clinical and arthroscopic examination after 3 months showed no significant change in symptoms, signs, or macroscopic appearances in either group. Surgical treatment was performed in 14 patients for deteriorating symptoms. Images PMID:7008711

Composition, biomass and structure of mangroves within the Zambezi River Delta

Treesearch

Carl C. Trettin; Christina E. Stringer; Stan Zarnoch

2015-01-01

We used a stratified random sampling design to inventory the mangrove vegetation within the Zambezi River Delta, Mozambique, to provide a basis for estimating biomass pools. We used canopy height, derived from remote sensing data, to stratify the inventory area, and then applied a spatial decision support system to objectively allocate sample plots among five...

The Additive Benefit of Hypnosis and Cognitive-Behavioral Therapy in Treating Acute Stress Disorder

ERIC Educational Resources Information Center

Bryant, Richard A.; Moulds, Michelle L.; Guthrie, Rachel M.; Nixon, Reginald D. V.

2005-01-01

This research represents the first controlled treatment study of hypnosis and cognitive- behavioral therapy (CBT) of acute stress disorder (ASD). Civilian trauma survivors (N = 87) who met criteria for ASD were randomly allocated to 6 sessions of CBT, CBT combined with hypnosis (CBT-hypnosis), or supportive counseling (SC). CBT comprised exposure,…

Evaluation of a Short-term, Cognitive-Behavioral Intervention for Primary Age Children with Anger-Related Difficulties

ERIC Educational Resources Information Center

Cole, Rachel L.; Treadwell, Susanne; Dosani, Sima; Frederickson, Norah

2013-01-01

This study evaluated the school-based short-term, cognitive-behavioral group anger management programme, "Learning How to Deal with our Angry Feelings" (Southampton Psychology Service, 2003). Thirteen groups of children aged 7- to 11-years-old were randomly allocated to two different cohorts: One cohort ("n"?=?35) first…

Longitudinal Effects of Induction on Teaching Skills and Attrition Rates of Beginning Teachers

ERIC Educational Resources Information Center

Helms-Lorenz, Michelle; van de Grift, Wim; Maulana, Ridwan

2016-01-01

The teaching profession faces a shortage as well as a decline of teaching skills. A possible way to mitigate this is to implement evidence-based induction arrangements. Seventy-one schools with 338 beginning secondary education teachers were randomly allocated to an experimental or a control group. The experimental schools used induction…

Effect of Task-Centered Instructional Programs on Hypertensives' Ability to Achieve and Maintain Reduced Dietary Sodium Intake.

ERIC Educational Resources Information Center

Mann, Karen V.; Sullivan, Patricia L.

This study sought to determine the effectiveness of systematically designed instructional programs in helping adult hypertensives to achieve and maintain dietary sodium intake. Sixty-six subjects were randomly allocated to one of three groups: task-centered instruction; task-centered instruction plus goal-setting and self-monitoring; or control.…

Interventions to Reduce Distress in Adult Victims of Rape and Sexual Violence: A Systematic Review

ERIC Educational Resources Information Center

Regehr, Cheryl; Alaggia, Ramona; Dennis, Jane; Pitts, Annabel; Saini, Michael

2013-01-01

Objectives: This article presents a systematic evaluation of the effectiveness of interventions aimed at reducing distress in adult victims of rape and sexual violence. Method: Studies were eligible for the review if the assignment of study participants to experimental or control groups was by random allocation or parallel cohort design. Results:…

Medical resource preparation and allocation for humanitarian assistance based on module organization.

PubMed

Zhu, Min; Chen, Ruxue; Zhong, Shaobo; Qian, Yangming; Huang, Quanyi

2017-02-01

This research aims to associate the allocation of medical resources with the function of the modular organization and the possible needs for humanitarian assistance missions. The overseas humanitarian medical assistance mission, which was sent after a disaster on the hospital ship Peace Ark, part of China's People's Liberation Army (PLA) Navy, was considered as study model. The cases used for clustering and matching sample formation were randomly selected from the existing information related to Peace Ark's mission. Categories of the reusable resources clustered by this research met the requirement of the actual consumption almost completely (more than 95%) and the categories of non-reusable resources met the requirement by more than 80%. In the mission's original resource preparing plan, more than 30% of the non-reusable resource categories remained unused during the mission. In the original resource preparing plan, some key non-reusable resources inventories were completely exhausted at the end of the mission, while 5% to 30% of non-reusable resources remained in the resource allocation plan generated by this research at the end of the mission. The medical resource allocation plan generated here can enhance the supporting level for the humanitarian assistance mission. This research could lay the foundation for an assistant decision-making system for humanitarian assistance mission.

Behavioral family intervention for children with developmental disabilities and behavioral problems.

PubMed

Roberts, Clare; Mazzucchelli, Trevor; Studman, Lisa; Sanders, Matthew R

2006-06-01

The outcomes of a randomized clinical trial of a new behavioral family intervention, Stepping Stones Triple P, for preschoolers with developmental and behavior problems are presented. Forty-eight children with developmental disabilities participated, 27 randomly allocated to an intervention group and 20 to a wait-list control group. Parents completed measures of parenting style and stress, and independent observers assessed parent-child interactions. The intervention was associated with fewer child behavior problems reported by mothers and independent observers, improved maternal and paternal parenting style, and decreased maternal stress. All effects were maintained at 6-month follow-up.

The reporting characteristics of bovine respiratory disease clinical intervention trials published prior to and following publication of the REFLECT statement.

PubMed

Totton, Sarah C; Cullen, Jonah N; Sargeant, Jan M; O'Connor, Annette M

2018-02-01

The goal of the REFLECT Statement (Reporting guidElines For randomized controLled trials in livEstoCk and food safeTy) (published in 2010) was to provide the veterinary research community with reporting guidelines tailored for randomized controlled trials for livestock and food safety. Our objective was to determine the prevalence of REFLECT Statement reporting of items 1-19 in controlled trials published in journals between 1970 and 2017 examining the comparative efficacy of FDA-registered antimicrobials against naturally acquired BRD (bovine respiratory disease) in weaned beef calves in Canada or the USA, and to compare the prevalence of reporting before and after 2010, when REFLECT was published. We divided REFLECT Statement, items 3, 5, 10, and 11 into subitems, because each dealt with multiple elements requiring separate assessment. As a result, 28 different items or subitems were evaluated independently. We searched MEDLINE ® and CABI (CAB Abstracts ® and Global Health ® ) (Web of Science™) in April 2017 and screened 2327 references. Two reviewers independently assessed the reporting of each item and subitem. Ninety-five references were eligible for the study. The reporting of the REFLECT items showed a point estimate for the prevalence ratio >1 (i.e. a higher proportion of studies published post-2010 reported this item compared to studies published pre-2010), apart from items 10.3, i.e., item 10, subitem 3 (who assigned study units to the interventions), 13 (the flow of study units through the study), 16 (number of study units in analysis), 18 (multiplicity), and 19 (adverse effects). Fifty-three (79%) of 67 studies published before 2010 and all 28 (100%) papers published after 2010 reported using a random allocation method in either the title, abstract, or methods (Prevalence ratio = 1.25; 95% CI (1.09,1.43)). However, 8 studies published prior to 2010 and 7 studies published post-2010 reported the term "systematic randomization" or variations of this term (which is not true randomization) to describe the allocation procedure. Fifty-five percent (37/67) of studies published pre-2010 reported blinding status (blinded/not blinded) of outcome assessors, compared to 24/28 (86%) of studies published post-2010 (Prevalence ratio = 1.5, 95% CI (1.19, 2.02)). The reporting of recommended items in journal articles in this body of work is generally improving; however, there is also evidence of confusion about what constitutes a random allocation procedure, and this suggests an educational need. As this study is observational, this precludes concluding that the publication of the REFLECT Statement was the cause of this trend. Copyright © 2017 Elsevier B.V. All rights reserved.

Long-term follow-up of laparoscopic electrocautery of the ovaries versus ovulation induction with recombinant FSH in clomiphene citrate-resistant women with polycystic ovary syndrome: an economic evaluation.

PubMed

Nahuis, M J; Oude Lohuis, E; Kose, N; Bayram, N; Hompes, P; Oosterhuis, G J E; Kaaijk, E M; Cohlen, B J; Bossuyt, P P M; van der Veen, F; Mol, B W; van Wely, M

2012-12-01

Laparoscopic electrocautery of the ovaries and ovulation induction with gonadotrophins are both second line treatments for women with clomiphene citrate-resistant polycystic ovary syndrome (PCOS). Long-term follow-up after electrocautery versus ovulation induction with gonadotrophins has demonstrated at least comparable chances for a first live born child with a reduced need for ovulation induction or assisted reproduction treatment and increased chances for a second live born child. In this study, we report on the long-term economic consequences of both treatment modalities. Between February 1998 and October 2001, we performed a multi-centre randomized controlled trial (RCT) comparing a strategy of laparoscopic electrocautery of the ovaries, followed by clomiphene citrate and gonadotrophins when anovulation persisted, and a strategy of ovulation induction with gonadotrophins in women with clomiphene citrate-resistant PCOS. Eight to twelve years after randomization we performed a follow-up study on reproductive outcome in these women and the fertility treatments they had needed including data on direct medical costs of pregnancy and delivery. Clinical data included number of treatment cycles, live births, miscarriages, ectopic pregnancies and multiple pregnancies. We calculated mean costs per woman after randomization until the first live birth. Confidence intervals (CIs) were estimated by bootstrapping. We obtained data for an economic analysis on 159 of the 168 randomized women (95%). In total, 71 of 83 women (86%) allocated to the electrocautery strategy and 69 of 85 women (81%) allocated to the gonadotrophin strategy had at least one live birth. Given the equivalence between the two treatment strategies in terms of a first live birth-the primary outcome measure-our analysis focused on the cost difference between the two strategies within a mean follow-up time of 8-12 years. The mean costs per first live birth after randomization were €11 176 (95% CI: €9689-€12 549) for the electrocautery group and €14 423 (95% CI: €12 239-€16 606) for the recombinant FSH group, resulting in significantly lower costs (P < 0.05) per first live birth for women allocated to the electrocautery group (mean difference €3247; 95% CI: €650-€5814). In women with clomiphene-resistant PCOS, laparoscopic electrocautery of the ovaries results in significantly lower costs per live birth than ovulation induction with gonadotrophins for an at least equal effectiveness.

The ASCENT (Allocation System Changes for Equity in Kidney Transplantation) Study: a Randomized Effectiveness-Implementation Study to Improve Kidney Transplant Waitlisting and Reduce Racial Disparity.

PubMed

Patzer, Rachel E; Smith, Kayla; Basu, Mohua; Gander, Jennifer; Mohan, Sumit; Escoffery, Cam; Plantinga, Laura; Melanson, Taylor; Kalloo, Sean; Green, Gary; Berlin, Alex; Renville, Gary; Browne, Teri; Turgeon, Nicole; Caponi, Susan; Zhang, Rebecca; Pastan, Stephen

2017-05-01

The United Network for Organ Sharing (UNOS) implemented a new Kidney Allocation System (KAS) in December 2014 that is expected to substantially reduce racial disparities in kidney transplantation among waitlisted patients. However, not all dialysis facility clinical providers and end stage renal disease (ESRD) patients are aware of how the policy change could improve access to transplant. We describe the ASCENT (Allocation System Changes for Equity in KidNey Transplantation) study, a randomized controlled effectiveness-implementation study designed to test the effectiveness of a multicomponent intervention to improve access to the early steps of kidney transplantation among dialysis facilities across the United States. The multicomponent intervention consists of an educational webinar for dialysis medical directors, an educational video for patients and an educational video for dialysis staff, and a dialysis-facility specific transplant performance feedback report. Materials will be developed by a multidisciplinary dissemination advisory board and will undergo formative testing in dialysis facilities across the United States. This study is estimated to enroll ~600 U.S. dialysis facilities with low waitlisting in all 18 ESRD Networks. The co-primary outcomes include change in waitlisting, and waitlist disparity at 1 year; secondary outcomes include changes in facility medical director knowledge about KAS, staff training regarding KAS, patient education regarding transplant, and a medical director's intent to refer patients for transplant evaluation. The results from the ASCENT study will demonstrate the feasibility and effectiveness of a multicomponent intervention designed to increase access to the deceased-donor kidney waitlist and reduce racial disparities in waitlisting.

Bezafibrate for the treatment of dyslipidemia in patients with coronary artery disease: 20-year mortality follow-up of the BIP randomized control trial.

PubMed

Arbel, Yaron; Klempfner, Robert; Erez, Aharon; Goldenberg, Ilan; Benzekry, Sagit; Shlomo, Nir; Fisman, Enrique Z; Tenenbaum, Alexander

2016-01-22

Recent data support the renewed interest in hypertriglyceridemia as a possible important therapeutic target for cardiovascular risk reduction. This study was designed to address the question of all-cause mortality during extended follow-up of the BIP trial in patients stratified by baseline triglyceride levels. In the BIP trial 3090 patients with proven coronary artery disease were randomized to bezafibrate 400 mg/day or placebo. All-cause mortality data after 20 years of follow-up, were obtained from the National Israeli Population Registry. Patients with hypertriglyceridemia (triglycerides ≥200 mg/dL, n = 458) were equally distributed among the study groups (15 % in both placebo and bezafibrate groups). During follow-up 1869 patients died (952 in placebo vs. 917 in bezafibrate group). Following multivariate adjustment allocation to bezafibrate was associated with small but significant 10 % mortality risk reduction (HR 0.90; 95 % CI 0.82-0.98, p = 0.026). Variables associated with significantly increased mortality risk were history of a past MI, NYHA class, diabetes, age, higher BMI and glucose level. In patients with hypertriglyceridemia multivariate analysis demonstrated a 25 % all-cause mortality risk reduction associated with allocation to bezafibrate (HR 0.75, CI 95 % 0.60-0.94; p = 0.012). In patients without hypertriglyceridemia bezafibrate had no significant effect on long-term mortality. During long-term follow-up bezafibrate-allocated patients experienced a modest but significant 10 % reduction in the adjusted risk of mortality. This effect of bezafibrate was more prominent among patients with baseline hypertriglyceridemia (25 % mortality risk reduction).

Are reports of randomized controlled trials improving over time? A systematic review of 284 articles published in high-impact general and specialized medical journals.

PubMed

To, Matthew J; Jones, Jennifer; Emara, Mohamed; Jadad, Alejandro R

2013-01-01

Inadequate reporting undermines findings of randomized controlled trials (RCTs). This study assessed and compared articles published in high-impact general medical and specialized journals. Reports of RCTs published in high-impact general and specialized medical journals were identified through a search of MEDLINE from January to March of 1995, 2000, 2005, and 2010. Articles that provided original data on adult patients diagnosed with chronic conditions were included in the study. Data on trial characteristics, reporting of allocation concealment, quality score, and the presence of a trial flow diagram were extracted independently by two reviewers, and discrepancies were resolved by consensus or independent adjudication. Descriptive statistics were used for quantitative variables. Comparisons between general medical and specialized journals, and trends over time were performed using Chi-square tests. Reports of 284 trials were analyzed. There was a significantly higher proportion of RCTs published with adequate reporting of allocation concealment (p = 0.003), presentation of a trial flow diagram (p<0.0001) and high quality scores (p = 0.038) over time. Trials published in general medical journals had higher quality scores than those in specialized journals (p = 0.001), reported adequate allocation concealment more often (p = 0.013), and presented a trial flow diagram more often (p<0.001). We found significant improvements in reporting quality of RCTs published in high-impact factor journals over the last fifteen years. These improvements are likely attributed to concerted international efforts to improve reporting quality such as CONSORT. There is still much room for improvement, especially among specialized journals.

Reporting of participant flow diagrams in published reports of randomized trials

PubMed Central

2011-01-01

Background Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. Methods A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. Results Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. Conclusions Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented. PMID:22141446

Study on psychoeducation enhancing results of adherence in patients with schizophrenia (SPERA-S): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Poor adherence to pharmacotherapy negatively affects the course and the outcome of schizophreniaspectrum psychoses, enhancing the risk of relapse. Falloon and coworkers developed a Psychoeducation Program aimed at improving communication and problem-solving abilities in patients and their families. This study set out to evaluate changes in adherence to pharmacotherapy in patients diagnosed with schizophrenia-spectrum psychoses, by comparing one group exposed to the Falloon Psychoeducation Program (FPP) with another group exposed to family supportive therapy with generic information on the disorders. Methods 340 patients diagnosed with schizophrenia and related disorders according to standardized criteria from 10 participating units distributed throughout the Italian National Health System (NHS), will be enrolled with 1:1 allocation by the method of blocks of randomized permutations. Patients will be reassessed at 6, 12 and 18 months after start of treatment (duration: 6 months). The primary objective is to evaluate changes in adherence to pharmacotherapy after psychoeducation. Adherence will be assessed at three-month intervals by measuring blood levels of the primary prescribed drug using high pressure liquid chromatography, and via the Medication Adherence Questionnaire and a modified version of the Adherence Interview. Secondary objectives are changes in the frequency of relapse and readmission, as the main indicator of the course of the disorder. Enrolled patients will be allocated to the FPP (yes/no) randomly, 1:1, in a procedure controlled by the coordinating unit; codes will be masked until the conclusion of the protocol (or the occurrence of a severe negative event). The raters will be blind to treatment allocation and will be tested for blinding after treatment completion. Intention-to-treat will be applied in considering the primary and secondary outcomes. Multiple imputations will be applied to integrate the missing data. The study started recruitment in February 2013; the total duration of the study is 27 months. Discussion If the psychoeducation program proves effective in improving adherence to pharmacotherapy and in reducing relapse and readmissions, its application could be proposed as a standard adjunctive psychosocial treatment within the Italian NHS. Trial registration Protocol Registration System of ClinicalTrials.gov NCT01433094; registered on 20 August 2011; first patient was randomized on 12 February 2013. PMID:24099414

TRUST-tPA trial: Telemedicine for remote collaboration with urgentists for stroke-tPA treatment.

PubMed

Mazighi, Mikael; Meseguer, Elena; Labreuche, Julien; Miroux, Patrick; Le Gall, Catherine; Roy, Patricia; Tubach, Florence; Amarenco, Pierre

2017-01-01

Background Previous observational studies have shown that telemedicine is feasible and safe to deliver intravenous (IV) recombinant tissue plasminogen activator (rt-PA). However, implementation of telemedicine may be challenging. To illustrate this fact, we report a study showing that telemedicine failed to improve clinical outcome and analyze the reasons for this shortcoming. Methods We established a tele-stroke network of 10 emergency rooms (ERs) of community hospitals connected to a stroke center to perform a randomized, open-label clinical trial with blinded outcome evaluation. Eligible patients were randomly assigned to either a usual care arm (i.e. immediate transfer to the stroke center and administration of IV rt-PA if indication was confirmed upon stroke arrival) or tele-thrombolysis arm (i.e. immediate administration of IV rt-PA in ER and transfer to the stroke center). The primary efficacy outcome was an excellent outcome (modified Rankin scale (mRS) 0-1 at 90 days). Secondary endpoints included favorable outcome (90-day mRS 0-2) and early neurological improvement (NIHSS score 0-1 at 24 hours or a decrease of ≥ 4 points within 24 hours). Safety outcomes included symptomatic intracerebral hemorrhage (ICH) per ECASS II definition, any ICH and all-cause mortality. Results During an accrual time of 48 months, because of a slow enrollment rate, only 49 of 270 patients initially planned for inclusion were randomized into usual care ( n = 23) and tele-thrombolysis ( n = 26). Despite random assignment, patients allocated to tele-thrombolysis were older and had more severe stroke than patients allocated to usual care. The median duration of video-conference was 23 minutes in the usual care arm and 73 minutes in the tele-thrombolysis arm. Eighty-four percent of patients in the tele-thrombolysis arm were treated by IV rt-PA in comparison to 18% in the usual care arm. In univariate analysis but not after adjustment for age and baseline NIHSS, patients allocated in the usual care arm had a higher rate of excellent or favorable outcome. There were no differences in safety outcomes, with only one symptomatic ICH occurring in the tele-thrombolysis arm. Conclusions Stroke patients included in the telemedicine arm of the TRUST-tPA trial increased their rt-PA eligibility five-fold. However, the efficacy and safety remains to be determined (ClinicalTrials.org, NCT00279149).

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)

PubMed Central

de SOUZA, Raphael Freitas; CHAVES, Carolina de Andrade Lima; CHAVES, Carolina de Andrade Lima; CHAVES, Carolina de Andrade Lima; NASSER, Mona; FEDOROWICZ, Zbys

2010-01-01

Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles. This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. Objective The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Material and methods Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. Criteria to assess methodological quality included: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-totreat analysis had been carried out. Results The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-totreat analysis or any similar procedure. Conclusions The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e.g. the CONSORT statement. PMID:20485919

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO).

PubMed

de Souza, Raphael Freitas; Chaves, Carolina de Andrade Lima; Nasser, Mona; Fedorowicz, Zbys

2010-01-01

Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. CRITERIA TO ASSESS METHODOLOGICAL QUALITY INCLUDED: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-to-treat analysis had been carried out. The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-to-treat analysis or any similar procedure. The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e.g. the CONSORT statement.

Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction.

PubMed

Homer, Dawn; Nightingale, Peter; Jobanputra, Paresh

2009-06-01

Communicating information about disease-modifying anti-rheumatic drugs (DMARDs) before patients start treatment is a key role for some rheumatology clinical nurse specialists. This is done in our unit to promote understanding of the risks and benefits of drug therapy and encourage timely and reliable use of DMARDs. Information is routinely provided individually but this can lead to delays in starting treatment because of limited nursing resources. In this randomized trial we tested the feasibility of giving patients, who were about to start on a DMARD, information about the drug in groups and compared this with information given individually. Adults with a clinical diagnosis of rheumatoid arthritis or psoriatic arthritis who were referred to the nursing team for counselling about starting on methotrexate, sulfasalazine or leflunomide were included. Patients who had previously taken a DMARD were not excluded and those consenting were randomized to receive drug information individually or in groups (of three to six patients). We provided all patients with written materials about the relevant drug and discussed the risks and benefits of drug use verbally. Patients allocated to group counselling received this intervention in a teaching room, with a slide presentation. The primary outcome was adherence with medication use, ascertained by pill counts, self-report diaries and prescription dispensation. Secondary outcomes included satisfaction with information about medicines (SIMS) by questionnaire; time taken to provide information; adherence to scheduled hospital appointments and blood monitoring schedules; and DMARD continuation rates at four and twelve months. Of 127 eligible patients referred for counselling about DMARDs, 62 consented to take part: 32 were randomized to receive drug information individually and 30 to receiving it in groups. Patients allocated to the two different interventions were comparable for age and diagnoses at baseline but more patients allocated individual counselling had not taken a DMARD previously: 56% (18/32) versus 20% (6/30). More patients counselled in groups were adherent (27/30; 90%) compared with patients counselled individually (22/32; 69%; p = 0.06) by pill counts. However, on self-report diaries, similar proportions were adherent (group counselling 97% (29/30) versus individual 94% (30/32); p = 1.0). All but two prescriptions were dispensed. More patients allocated to individual counselling missed at least one blood monitoring visit (25% versus 17%; p = 0.54) and at least one scheduled clinic visit (19% versus 3%; p = 0.10). SIMS scores indicated high levels of patient satisfaction and were similar for both groups. The time taken to run group and individual counselling sessions were similar (median of 35 minutes versus 33 minutes, respectively). Nursing time per individual patient in those allocated group counselling was 11.6 minutes. Drug continuation rates were higher for those counselled in groups compared with those counselled individually: at four months, 73% versus 63 %; p = 0.42; at twelve months, 47% versus 38%; p = 0.61). Our pilot study demonstrated the feasibility of providing counselling on DMARDs to groups of patients with important time savings for specialist nurses and while maintaining high levels of patient satisfaction. There was a trend for better outcomes in terms of adherence and drug continuation rates for patients counselled in groups, indicating potential benefits from group interactions. However, these findings need to be investigated further in a larger, fully powered trial. 2008 John Wiley & Sons, Ltd.

A RANDOMIZED TRIAL OF BIRTHING WITH AND WITHOUT STIRRUPS

PubMed Central

CORTON, Marlene M.; LANKFORD, Janice C.; AMES, Rebecca; MCINTIRE, Donald D.; ALEXANDER, James M.; LEVENO, Kenneth J.

2012-01-01

OBJECTIVE To determine if bed delivery without stirrups reduces the incidence of perineal lacerations compared to delivery in stirrups. STUDY DESIGN In this randomized trial we compared bed delivery without stirrups to delivery in stirrups in nulliparous women. The primary outcome was any perineal laceration (first- through fourth-degree). RESULTS 108 women were randomized to delivery without stirrups and 106 to stirrups. A total of 82 (76%) women randomized to no stirrups sustained perineal lacerations compared to 83 (78%) in women allocated to stirrups, p = .8. There was no significant difference in the severity of lacerations or in obstetric outcomes such as prolonged second stage of labor, forceps delivery, or cesarean birth. Similarly, infant outcomes were unaffected. CONCLUSION Our results do not incriminate stirrups as a cause of perineal lacerations. Alternatively, our findings of no difference in perineal lacerations suggest that delivering in bed without stirrups confers no advantages nor disadvantages. PMID:22840725

Evaluation of Brief Group-Administered Instruction for Parents to Prevent or Minimize Sleep Problems in Young Children with Down Syndrome

ERIC Educational Resources Information Center

Stores, Rebecca; Stores, Gregory

2004-01-01

Background: The study concerns the unknown value of group instruction for mothers of young children with Down syndrome (DS) in preventing or minimizing sleep problems. Method: (1) Children with DS were randomly allocated to an Instruction group (given basic information about children's sleep) and a Control group for later comparison including…

South Winnipeg Integrated Geriatric Program (SWING): A Rapid Community-Response Program for the Frail Elderly

ERIC Educational Resources Information Center

Montgomery, Patrick R.; Fallis, Wendy M.

2003-01-01

The objective of this study was to compare enhanced access to geriatric assessment and case management to usual home care service provision for the frail elderly. This was a demonstration project, with randomized allocation to control or intervention groups of frail elderly persons who had been referred to the Home Care service in Winnipeg. Of the…

Dietary Bacillus subtilis-based direct-fed microbials alleviate LPS-induced intestinal immunological stress and improve intestinal barrier gene expression in commercial broiler chickens

USDA-ARS?s Scientific Manuscript database

The present study investigated the effects of B. subtilis-based probiotics on performance, modulation of host inflammatory responses and intestinal barrier integrity of broilers subjected to LPS challenge. Birds at day 0 of age were randomly allocated to one of the 3 dietary treatments - controls, ...

Using "The Transporters DVD" as a Learning Tool for Children with Autism Spectrum Disorders (ASD)

ERIC Educational Resources Information Center

Young, Robyn L.; Posselt, Miriam

2012-01-01

Data from two groups of children who were randomly allocated to those groups showed that the ability of children with ASD to identify and label basic and complex facial expressions following a 3-week home based DVD intervention significantly improved when viewing "The Transporters" DVD. Improvements in emotion recognition appear related to the…

Paper-Based and Computer-Based Concept Mappings: The Effects on Computer Achievement, Computer Anxiety and Computer Attitude

ERIC Educational Resources Information Center

Erdogan, Yavuz

2009-01-01

The purpose of this paper is to compare the effects of paper-based and computer-based concept mappings on computer hardware achievement, computer anxiety and computer attitude of the eight grade secondary school students. The students were randomly allocated to three groups and were given instruction on computer hardware. The teaching methods used…

Effects on Coping Skills and Anxiety of a Universal School-Based Mental Health Intervention Delivered in Scottish Primary Schools

ERIC Educational Resources Information Center

Collins, Sabrina; Woolfson, Lisa Marks; Durkin, Kevin

2014-01-01

Anxiety disorders are common in children and may signal risk of depression, social, or academic difficulties. This study evaluated the effects of a universal mental health promotion intervention delivered in primary schools. Three hundred and seventeen 9- to 10-year-olds were randomly allocated by class group to intervention conditions…

Camelina meal supplementation to beef cattle: III. Effects on acute-phase and thyroid responses

USDA-ARS?s Scientific Manuscript database

Sixty Angus x Hereford steers were ranked by BW on d -28 of the study and allocated to 20 drylot pens, which were randomly assigned to receive: 1) supplement containing (as-fed basis) 84% corn, 14% soybean meal, and 2% mineral mix (CO) offered during preconditioning (PC; d -28 to 0) and feedlot rece...

A Comparison of Short- And Long-Term Family Therapy for Adolescent Anorexia Nervosa.

ERIC Educational Resources Information Center

Lock, James; Agras, W. Stewart; Bryson, Susan; Kraemer, Helena C.

2005-01-01

Objective: Research suggests that family treatment for adolescents with anorexia nervosa may be effective. This study was designed to determine the optimal length of such family therapy. Method: Eighty-six adolescents (12-18 years of age) diagnosed with anorexia nervosa were allocated at random to either a short-term (10 sessions over 6 months) or…

The Effect of Diagnostic Label on Care Staff's Perceptions of Cause of Challenging Behaviour in Individuals with Learning Disabilities

ERIC Educational Resources Information Center

Gifford, Clive; Knott, Fiona

2016-01-01

Background: This study investigated whether care staff's causal attributions and emotional reactions to the challenging behaviour displayed by service users were influenced by the service user's diagnostic label. Materials and Method: One hundred and twenty care staff were randomly allocated to one of three conditions. Participants viewed a video…

Enhancing the Mental Health Promotion Component of a Health and Personal Development Programme in Irish Schools

ERIC Educational Resources Information Center

Fitzpatrick, Carol; Conlon, Andrea; Cleary, Deirdre; Power, Mike; King, Frances; Guerin, Suzanne

2013-01-01

This study set out to examine the impact of a health and personal development programme (the Social, Personal and Health Education Programme) which had been "enhanced" by the addition of a mental health promotion component. Students aged 12-16 years attending 17 secondary schools were randomly allocated as clusters to participate in…

Learning where to look: electrophysiological and behavioral indices of visual search in young and old subjects.

PubMed

Looren de Jong, H; Kok, A; Woestenburg, J C; Logman, C J; Van Rooy, J C

1988-06-01

The present investigation explores the way young and elderly subjects use regularities in target location in a visual display to guide search for targets. Although both young and old subjects show efficient use of search strategies, slight but reliable differences in reaction times suggest decreased ability in the elderly to use complex cues. Event-related potentials were very different for the young and the old. In the young, P3 amplitudes were larger on trials where the rule that governed the location of the target became evident; this was interpreted as an effect of memory updating. Enhanced positive Slow Wave amplitude indicated uncertainty in random search conditions. Elderly subjects' P3 and SW, however, seemed unrelated to behavioral performance, and they showed a large negative Slow Wave at central and parietal sites to randomly located targets. The latter finding was tentatively interpreted as a sign of increased effort in the elderly to allocate attention in visual space. This pattern of behavioral and ERP results suggests that age-related differences in search tasks can be understood in terms of changes in the strategy of allocating visual attention.

Random Forest Segregation of Drug Responses May Define Regions of Biological Significance.

PubMed

Bukhari, Qasim; Borsook, David; Rudin, Markus; Becerra, Lino

2016-01-01

The ability to assess brain responses in unsupervised manner based on fMRI measure has remained a challenge. Here we have applied the Random Forest (RF) method to detect differences in the pharmacological MRI (phMRI) response in rats to treatment with an analgesic drug (buprenorphine) as compared to control (saline). Three groups of animals were studied: two groups treated with different doses of the opioid buprenorphine, low (LD), and high dose (HD), and one receiving saline. PhMRI responses were evaluated in 45 brain regions and RF analysis was applied to allocate rats to the individual treatment groups. RF analysis was able to identify drug effects based on differential phMRI responses in the hippocampus, amygdala, nucleus accumbens, superior colliculus, and the lateral and posterior thalamus for drug vs. saline. These structures have high levels of mu opioid receptors. In addition these regions are involved in aversive signaling, which is inhibited by mu opioids. The results demonstrate that buprenorphine mediated phMRI responses comprise characteristic features that allow a supervised differentiation from placebo treated rats as well as the proper allocation to the respective drug dose group using the RF method, a method that has been successfully applied in clinical studies.

Efficacy of kinesio taping on isokinetic quadriceps torque in knee osteoarthritis: a double blinded randomized controlled study.

PubMed

Anandkumar, Sudarshan; Sudarshan, Shobhalakshmi; Nagpal, Pratima

2014-08-01

Double blind pre-test post-test control group design. To compare the isokinetic quadriceps torque, standardized stair-climbing task (SSCT) and pain during SSCT between subjects diagnosed with knee osteoarthritis pre and post kinesio tape (KT) application with and without tension. Strength of the quadriceps and torque producing capability is frequently found to be compromised in knee osteoarthritis. The efficacy of KT in improving isokinetic quadriceps torque in knee osteoarthritis is unknown, forming the basis for this study. Forty subjects were randomly allocated to either the experimental (therapeutic KT with tension) or control group (sham KT without tension) with the allocation being concealed. Pre and post test measurements of isokinetic quadriceps torque, SSCT and pain during SSCT were carried out by a blinded assessor. A large effect size with significant improvements in the peak quadriceps torque (concentric and eccentric at angular velocities of 90° per second and 120° per second), SSCT and pain were obtained in the experimental group when compared to the control group. Application of therapeutic KT is effective in improving isokinetic quadriceps torque, SSCT and reducing pain in knee osteoarthritis.

Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial.

PubMed

Rand, Debbie; Zeilig, Gabi; Kizony, Rachel

2015-06-18

Impaired dexterity of the weaker upper extremity is common post stroke and it is recommended that these individuals practice many repetitions of movement to regain function. However, stroke rehabilitation methods do not achieve the required intensity to be effective. Touchscreen tablet technology may be used as a motivating tool for self-training impaired dexterity of the weaker upper extremity post stroke. Rehab-let is a self-training protocol utilizing game apps on a touchscreen for practicing movement of the weaker upper extremity. We will conduct a pilot randomized controlled trial to assess Rehab-let compared to traditional self-training to improve dexterity of the weaker hand, and to increase self-training time and satisfaction in individuals with subacute stroke. Forty individuals with stroke undergoing subacute rehabilitation will be randomly allocated to Rehab-let or a traditional self-training program using therapeutic aids such as balls, blocks and pegs. All participants will be requested to perform self-training for 60 minutes a day, 5 times a week for 4 weeks. Dexterity assessed by The Nine Hole Peg Test is the main outcome measure. Assessments will be administered pre and post the self-training intervention by assessors blind to the group allocation. The outcomes of this study will inform the design of a fully powered randomized controlled trial to evaluate the effectiveness of Rehab-let. If found to be effective, Rehab-let can be used during subacute rehabilitation to increase treatment intensity and improve dexterity. Potentially, Rehab-let can also be used after discharge and might be ideal for individuals with mild stroke who are often not referred to formal rehabilitation. Current Controlled Trials NCT02136433 registered on 17 September 2014.

Treatment of retained placenta with misoprostol: a randomised controlled trial in a low-resource setting (Tanzania).

PubMed

van Beekhuizen, Heleen J; Pembe, Andrea B; Fauteck, Heiner; Lotgering, Fred K

2009-10-23

Retained placenta is one of the common causes of maternal mortality in developing countries where access to appropriate obstetrical care is limited. Current treatment of retained placenta is manual removal of the placenta under anaesthesia, which can only take place in larger health care facilities. Medical treatment of retained placenta with prostaglandins E1 (misoprostol) could be cost-effective and easy-to-use and could be a life-saving option in many low-resource settings. The aim of this study is to assess the efficacy and safety of sublingually administered misoprostol in women with retained placenta in a low resource setting. Multicentered randomised, double-blind, placebo-controlled trial, to be conducted in 5 hospitals in Tanzania, Africa. Women with retained placenta, at a gestational age of 28 weeks or more and blood loss less than 750 ml, 30 minutes after delivery of the newborn despite active management of third stage of labour. Trial Entry & Randomisation & Study Medication: After obtaining informed consent, eligible women will be allocated randomly to the treatment groups using numbered envelopes that will be randomized in variable blocks containing identical capsules with either 800 microgram of misoprostol or placebo. The drugs will be given sublingually. The women, maternal care providers and researchers will be blinded to treatment allocation. 117 women, to show a 40% reduction in manual removals of the placenta (p = 0.05, 80% power). The randomization will be misoprostol: placebo = 2:1. PRIMARY STUDY OUTCOME: Expulsion of the placenta without manual removal. Secondary outcome is the number of blood transfusions. This is a protocol for a randomized trial in a low resource setting to assess if medical treatment of women with retained placenta with misoprostol reduces the incidence of manual removal of the placenta. Current Controlled Trials ISRCTN16104753.

The Conduct and Reporting of Child Health Research: An Analysis of Randomized Controlled Trials Published in 2012 and Evaluation of Change over 5 Years.

PubMed

Gates, Allison; Hartling, Lisa; Vandermeer, Ben; Caldwell, Patrina; Contopoulos-Ioannidis, Despina G; Curtis, Sarah; Fernandes, Ricardo M; Klassen, Terry P; Williams, Katrina; Dyson, Michele P

2018-02-01

For child health randomized controlled trials (RCTs) published in 2012, we aimed to describe design and reporting characteristics and evaluate changes since 2007; assess the association between trial design and registration and risk of bias (RoB); and assess the association between RoB and effect size. For 300 RCTs, we extracted design and reporting characteristics and assessed RoB. We assessed 5-year changes in design and reporting (based on 300 RCTs we had previously analyzed) using the Fisher exact test. We tested for associations between design and reporting characteristics and overall RoB and registration using the Fisher exact, Cochran-Armitage, Kruskal-Wallis, and Jonckheere-Terpstra tests. We pooled effect sizes and tested for differences by RoB using the χ 2 test for subgroups in meta-analysis. The 2012 and 2007 RCTs differed with respect to many design and reporting characteristics. From 2007 to 2012, RoB did not change for random sequence generation and improved for allocation concealment (P < .001). Fewer 2012 RCTs were rated high overall RoB and more were rated unclear (P = .03). Only 7.3% of 2012 RCTs were rated low overall RoB. Trial registration doubled from 2007 to 2012 (23% to 46%) (P < .001) and was associated with lower RoB (P = .009). Effect size did not differ by RoB (P = .43) CONCLUSIONS: Random sequence generation and allocation concealment were not often reported, and selective reporting was prevalent. Measures to increase trialists' awareness and application of existing reporting guidance, and the prospective registration of RCTs is needed to improve the trustworthiness of findings from this field. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

PubMed

Bazazi, Alexander R; Wickersham, Jeffrey A; Wegman, Martin P; Culbert, Gabriel J; Pillai, Veena; Shrestha, Roman; Al-Darraji, Haider; Copenhaver, Michael M; Kamarulzaman, Adeeba; Altice, Frederick L

2017-08-01

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: a randomized controlled trial.

PubMed

Gulluoglu, Bahadir M; Guler, Sertac Ata; Ugurlu, M Umit; Culha, Gulcan

2013-01-01

To assess the impact of prophylactic antibiotics on the prevention of surgical site infection (SSI) and the cost-effectiveness of this prophylaxis for breast cancer surgery in overweight or obese women. SSI is higher than expected after breast surgery. Obesity was found to be one of the risk factors. The trial was designed as a phase IV randomized, controlled, parallel-group efficacy trial. It was conducted at a tertiary university hospital. Overweight or obese women with clinically early-stage breast cancer who had been assigned to undergo surgery were eligible. Patients were randomly allocated to either a prophylaxis or a control group by using a computer-generated list. The prophylaxis group received 1 g ampicillin-sulbactam intravenously at anesthesia. The control group received no intervention. Patients and observers were blinded to the assignments. The primary outcome was the comparison of SSI incidences of the 2 groups. Patients were monitored for 30 days. A total of 369 patients were included in final analysis, out of which 187 were allocated for prophylaxis and 182 were randomly assigned to the control group. Analysis was done according to the intention-to-treat principle. Prophylaxis significantly reduced the SSI rate (4.8%) in the prophylaxis group when compared with that in the control group [13.7%; relative risk (RR) 0.35; 95% CI: 0.17-0.73]. No adverse reaction was observed. The mean SSI-related cost (20.26 USD) was found to be significantly higher in the control group when compared with that (8.48 USD) in the prophylaxis group. Antibiotic prophylaxis significantly decreased SSI incidence after elective surgery and was shown to be cost-effective in obese breast cancer patients. ClinicalTrials.gov Identifier: NCT00356148.

Accelerated Titration of Oxytocin in Nulliparous Women with Labour Dystocia: Results of the ACTION Pilot Randomized Controlled Trial.

PubMed

Dy, Jessica; Rainey, Jenna; Walker, Mark C; Fraser, William; Smith, Graeme N; White, Ruth Rennicks; Waddell, Patti; Janoudi, Ghayath; Corsi, Daniel J; Wei, Shu Qin

2018-06-01

The primary objective was to determine the feasibility of a large RCT assessing the effectiveness of an accelerated oxytocin titration (AOT) protocol compared with a standard gradual oxytocin titration (GOT) in reducing the risk of CS in nulliparous women diagnosed with dystocia in the first stage of labour. The secondary objective was to obtain preliminary data on the safety and efficacy of the foregoing AOT protocol. This was a multicentre, double-masked, parallel-group pilot RCT. This study was conducted in three Canadian birthing centres. A total of 79 term nulliparous women carrying a singleton pregnancy in spontaneous labour, with a diagnosis of labour dystocia, were randomized to receive either GOT (initial dose 2 mU/min with increments of 2 mU/min) or AOT (initial dose 4 mU/min with increments of 4 mU/min), in a 1:1 ratio. An intention-to-treat analysis was applied. A total of 252 women were screened and approached, 137 (54.4%) consented, and 79 (31.3%) were randomized. Overall protocol adherence was 76 of 79 (96.2%). Of the women randomized, 10 (25.6%) allocated to GOT had a CS compared with six (15.0%) allocated to AOT (Fisher exact test P = 0.27). This pilot study demonstrated that a large, multicentre RCT is not only feasible, but also necessary to assess the effectiveness and safety of an AOT protocol for labour augmentation with regard to CS rate and indicators of maternal and perinatal morbidities. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

Randomized trial of constraint-induced movement therapy and bimanual training on activity outcomes for children with congenital hemiplegia.

PubMed

Sakzewski, Leanne; Ziviani, Jenny; Abbott, David F; Macdonell, Richard A L; Jackson, Graeme D; Boyd, Roslyn N

2011-04-01

To determine if constraint-induced movement therapy (CIMT) is more effective than bimanual training (BIM) in improving upper limb activity outcomes for children with congenital hemiplegia in a matched-pairs randomized trial. Sixty-three children (mean age 10.2, SD 2.7, range 5-16 y; 33 males, 30 females), 16 in Manual Ability Classification System level I, 46 level II, and 1 level III and 16 in Gross Motor Function Classification level I, 47 level II) were randomly allocated to either CIMT or BIM group day camps (60 hours over 10 days). The Melbourne Assessment of Unilateral Upper Limb Function assessed unimanual capacity of the impaired limb and Assisting Hand Assessment evaluated bimanual coordination at baseline, 3 and 26 weeks, scored by blinded raters. After concealed random allocation, there was no baseline difference between groups. CIMT had superior outcomes compared with BIM for unimanual capacity at 26 weeks (estimated mean difference [EMD] 4.4, 95% confidence interval [CI] 2.2-6.7; p < 0.001). There was no other significant difference between groups post-intervention. Both groups demonstrated significant improvements in bimanual performance at 3 weeks, with gains maintained by BIM at 26 weeks (EMD 2.3; 95% CI 0.6-4.0; p = 0.008). Interpretation  Overall, there were only small differences between the two training approaches. CIMT yielded greater changes in unimanual capacity of the impaired upper limb compared with BIM. Results generally reflect specificity of practice, with CIMT improving unimanual capacity and BIM improving bimanual performance. Considerable inter-individual variation in response to either intervention was evident. Future research should consider serial sequencing unimanual then BIM approaches to optimize upper limb outcomes for children with congenital hemiplegia. © The Authors. Journal compilation © Mac Keith Press 2011.

Observational Study Designs for Comparative Effectiveness Research: An Alternative Approach to Close Evidence Gaps in Head-and-Neck Cancer

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

Goulart, Bernardo H.L., E-mail: bhg@uw.edu; University of Washington, Seattle, Washington; Ramsey, Scott D.

Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H and N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in H and N RCTs, which limits the validity of their results to the broader H and N cancer patient population seenmore » in clinical practice. Randomized controlled trials often do not address other knowledge gaps in the management of H and N cancer, including treatment comparisons for rare types of H and N cancers, monitoring of rare or late toxicity events (eg, osteoradionecrosis), or in some instances an RCT is simply not feasible. Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomization, may address several of these gaps in knowledge, thereby complementing the role of RCTs. This critical review discusses how observational CER studies complement RCTs in generating the evidence to inform healthcare decisions and improve the quality of care and outcomes of H and N cancer patients. Review topics include a balanced discussion about the strengths and limitations of both RCT and observational CER study designs; a brief description of design and analytic techniques to handle selection bias in observational studies; examples of observational studies that inform current clinical practices and management of H and N cancers; and suggestions for relevant CER questions that could be addressed by an observational study design.« less

Observational study designs for comparative effectiveness research: an alternative approach to close evidence gaps in head-and-neck cancer.

PubMed

Goulart, Bernardo H L; Ramsey, Scott D; Parvathaneni, Upendra

2014-01-01

Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H&N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in H&N RCTs, which limits the validity of their results to the broader H&N cancer patient population seen in clinical practice. Randomized controlled trials often do not address other knowledge gaps in the management of H&N cancer, including treatment comparisons for rare types of H&N cancers, monitoring of rare or late toxicity events (eg, osteoradionecrosis), or in some instances an RCT is simply not feasible. Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomization, may address several of these gaps in knowledge, thereby complementing the role of RCTs. This critical review discusses how observational CER studies complement RCTs in generating the evidence to inform healthcare decisions and improve the quality of care and outcomes of H&N cancer patients. Review topics include a balanced discussion about the strengths and limitations of both RCT and observational CER study designs; a brief description of design and analytic techniques to handle selection bias in observational studies; examples of observational studies that inform current clinical practices and management of H&N cancers; and suggestions for relevant CER questions that could be addressed by an observational study design. Copyright © 2014 Elsevier Inc. All rights reserved.

The Treatment of Brain Arteriovenous Malformation Study (TOBAS): A preliminary inter- and intra-rater agreement study on patient management.

PubMed

Fahed, Robert; Batista, André L; Darsaut, Tim E; Gentric, Jean-Christophe; Ducroux, Célina; Chaalala, Chiraz; Roberge, David; Bojanowski, Michel W; Weill, Alain; Roy, Daniel; Magro, Elsa; Raymond, Jean

2017-07-01

The best management of brain arteriovenous malformation (bAVM) patients remains unknown. Randomized allocation may be more readily accepted when there is uncertainty and disagreement regarding the management of potential participants. In planning for a trial, we aimed to assess variability and agreement among physicians managing bAVM patients. A portfolio composed of 35 patients was sent to 47 clinicians of various specialties managing bAVM patients. For each patient, physicians were asked their best management decision (surgery/embolization/radiosurgery/conservative), their confidence level, and whether they would include the patient in a randomized trial comparing conservative and curative management. Seven physicians, who had access to all images of each patient, independently responded twice, to assess inter and intra-rater agreement using kappa statistics. The inter-rater agreement (30 raters, including 16 neuroradiologists) for best management decision was only "fair" (κ [95%CI]=0.210[0.157; 0.295]). Agreement remained below 'substantial' (κ<.6) between physicians of the same specialty, and when no distinctions were made between various treatments (when responses were dichotomized as conservative versus curative). With access to all images the inter-rater agreement remained fair. The intra-rater agreement reached "substantial" only for the dichotomized decisions. Responding clinicians were willing to include 54.4% of patients (mainly unruptured bAVMs) in a randomized trial. There is a lack of agreement among clinicians involved in the management of bAVM patients. In this study a substantial proportion of clinicians were willing to offer randomized allocation of management options to a substantial number of patients. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Transfusion Requirements in Cardiac Surgery III (TRICS III): Study Design of a Randomized Controlled Trial.

PubMed

Shehata, Nadine; Whitlock, Richard; Fergusson, Dean A; Thorpe, Kevin E; MacAdams, Charlie; Grocott, Hilary P; Rubens, Fraser; Fremes, Stephen; Lellouche, Francois; Bagshaw, Sean; Royse, Alistair; Rosseel, Peter M; Hare, Greg; Medicis, Etienne De; Hudson, Christopher; Belley-Cote, Emilie; Bainbridge, Daniel; Kent, Blaine; Shaw, Andrew; Byrne, Kelly; Syed, Summer; Royse, Colin F; McGuiness, Shay; Hall, Judith; Mazer, C David

2018-02-01

To determine if a restrictive transfusion threshold is noninferior to a higher threshold as measured by a composite outcome of mortality and serious morbidity. Transfusion Requirements in Cardiac Surgery (TRICS) III was a multicenter, international, open-label randomized controlled trial of two commonly used transfusion strategies in patients having cardiac surgery using a noninferiority trial design (ClinicalTrials.gov number, NCT02042898). Eligible patients were randomized prior to surgery in a 1:1 ratio. Potential participants were 18 years or older undergoing planned cardiac surgery using cardiopulmonary bypass (CPB) with a preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more. Five thousand patients; those allocated to a restrictive transfusion group received a red blood cell (RBC) transfusion if the hemoglobin concentration (Hb) was less than 7.5 g/dL intraoperatively and/or postoperatively. Patients allocated to a liberal transfusion strategy received RBC transfusion if the Hb was less than 9.5 g/dL intraoperatively or postoperatively in the intensive care unit or less than 8.5 g/dL on the ward. The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, or new onset renal dysfunction requiring dialysis at hospital discharge or day 28, whichever comes first. The primary outcome was analyzed as a per-protocol analysis. The trial monitored adherence closely as adherence to the transfusion triggers is important in ensuring that measured outcomes reflect the transfusion strategy. By randomizing prior to surgery, the TRICS III trial captured the most acute reduction in hemoglobin during cardiopulmonary bypass. Copyright © 2018. Published by Elsevier Inc.

One-day compared with 7-day nitrofurantoin for asymptomatic bacteriuria in pregnancy: a randomized controlled trial.

PubMed

Lumbiganon, Pisake; Villar, Jose; Laopaiboon, Malinee; Widmer, Mariana; Thinkhamrop, Jadsada; Carroli, Guillermo; Duc Vy, Nguyen; Mignini, Luciano; Festin, Mario; Prasertcharoensuk, Witoon; Limpongsanurak, Sompop; Liabsuetrakul, Tippawan; Sirivatanapa, Pannee

2009-02-01

To evaluate whether a 1-day nitrofurantoin regimen is as effective as a 7-day regimen in eradicating asymptomatic bacteriuria during pregnancy. A multicenter, double-blind, randomized, placebo controlled noninferiority trial was conducted in antenatal clinics in Thailand, the Philippines, Vietnam, and Argentina. Pregnant women seeking antenatal care between March 2004 and March 2007 who met the inclusion and exclusion criteria were invited to participate in the study. Those who consented were randomly allocated to receive either a 1-day or a 7-day course of 100 mg capsules of nitrofurantoin, which was taken twice daily. The primary outcome was bacteriologic cure on day 14 of treatment. : A total of 1,248 of 24,430 eligible women had asymptomatic bacteriuria, making the overall prevalence of 5.1%. Of these 1,248 women, 778 women were successfully recruited, and 386 and 392 women were randomly allocated to 1-day and 7-day regimens, respectively. Escherichia coli was the most common potentially pathogenic bacteria detected, its prevalence approaching 50%. Bacteriologic cure rates at treatment day 14 were 75.7% and 86.2% for 1-day and 7-day regimens, respectively. The cure rate difference was -10.5% (95% confidence interval -16.1% to -4.9%). Mean birth weight and mean gestational age at delivery were significantly lower in the 1-day regimen group. There were fewer adverse effects in the 1-day regimen group, but the differences were not statistically significant. A 1-day regimen of nitrofurantoin is significantly less effective than a 7-day regimen. Women with asymptomatic bacteriuria in pregnancy should receive the standard 7-day regimen. ISRCTN, isrctn.org, ISRCTN11966080 I.

Has the quality of reporting in periodontology changed in 14 years? A systematic review.

PubMed

Leow, Natalie M; Hussain, Zahra; Petrie, Aviva; Donos, Nikolaos; Needleman, Ian G

2016-10-01

Quality of reporting randomized controlled trials (RCTs) in periodontology has been poor. Consolidated Standards of Reporting Trials guidelines and an extension for non-pharmacologic trials (CONSORT-NPE), were introduced to aid in improving this. The aim of this study was to assess the quality of reporting in periodontology, changes over the last 14 years, and adherence to CONSORT-NPE. Randomized controlled trials in humans, published in three periodontal journals, from 2013 to 2015 were included. Search was conducted through Medline, Embase and hand searching. One hundred and seventy-three full-text articles included. Two reviewers screened for reporting quality (κ = 0.69, 95% CI 0.60-0.76). 84% of studies (n = 145) described randomization methods, 74% (n = 128) highlighted examiner blinding and 87% (n = 151) accounted for patients at study conclusion. Patient and caregiver blinding was addressed in 50% (n = 70) and 50% (n = 27) of studies respectively. 64% (n = 110) described adequate allocation concealment. Compared with Montenegro et al. (2002, Journal of Dental Research, 81, 866), improvements seen in describing randomization (2002, 16.5%; 2016, 84%), allocation concealment (2002, 6.5%; 2016, 64%), caregiver masking (2002, 17%; 2016, 50%). CONSORT-NPE; 62% (n = 107) had detailed explanations of all treatments, 88% (n = 152) lacked protocols for adherence of caregivers' to an intervention. Only 17% (n = 29) described caregivers' expertise and case volume. Substantial improvements have occurred. Attention is required for statistical analysis of patient losses and masking. CONSORT-NPE aspects were poorly reported. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension: results from the PREVER-treatment randomized trial.

PubMed

Fuchs, Flávio D; Scala, Luiz César N; Vilela-Martin, José F; de Mello, Renato Bandeira; Mosele, Francisca; Whelton, Paul K; Poli-de-Figueiredo, Carlos E; de Alencastro, Paulo Ricardo; E Silva, Ricardo Pereira; Gus, Miguel; Bortolotto, Luiz Aparecido; Schlatter, Rosane; Cesarino, Evandro José; Castro, Iran; Neto, José A Figueiredo; Chaves, Hilton; Steffens, André Avelino; Alves, João Guilherme; Brandão, Andréa Araujo; de Sousa, Marcos R; Jardim, Paulo Cesar; Moreira, Leila B; Franco, Roberto Silva; Gomes, Marco Mota; Neto, Abrahão Afiune; Fuchs, Felipe Costa; Filho, Dario C Sobral; Nóbrega, Antônio C; Nobre, Fernando; Berwanger, Otávio; Fuchs, Sandra C

2016-04-01

To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of stage I hypertension. In a randomized, double-blind, controlled trial, 655 participants were followed for 18 months in 21 Brazilian academic centers. Trial participants were adult volunteers aged 30-70 years with stage I hypertension (BP 140-159 or 90-99 mmHg) following 3 months of a lifestyle intervention. Participants were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 333) or 50 mg of losartan (N = 322). If BP remained uncontrolled after 3 months, study medication dose was doubled, and if uncontrolled after 6 months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg twice daily) were added as open-label drugs in a progressive fashion. At the end of follow-up, 609 (93%) participants were evaluated. The difference in SBP during 18 months of follow-up was 2.3 (95% confidence interval: 1.2 to 3.3) mmHg favoring chlorthalidone/amiloride. Compared with those randomized to diuretic, more participants allocated to losartan had their initial dose doubled and more of them used add-on antihypertensive medication. Levels of blood glucose, glycosilated hemoglobin, and incidence of diabetes were no different between the two treatment groups. Serum potassium was lower and serum cholesterol was higher in the diuretic arm. Microalbuminuria tended to be higher in patients with diabetes allocated to losartan (28.5 ± 40.4 versus 16.2 ± 26.7 mg, P = 0.09). Treatment with a combination of chlorthalidone and amiloride compared with losartan yielded a greater reduction in BP. NCT00971165.

Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening.

PubMed

Wong, Arthur D; Kirby, John; Guyatt, Gordon H; Moayyedi, Paul; Vora, Parag; You, John J

2013-02-11

Investigators often face challenges when recruiting participants into randomized controlled trials (RCTs). Some data suggest that telephone reminders may lead to greater participant enrollment. Patients aged 50 to 70 years from family practice rosters were initially mailed invitations to participate in an RCT of colorectal cancer screening. Patients who did not respond were randomly allocated to follow-up invitations by either telephone or mail four weeks after the initial invitation. The primary outcome was attendance for eligibility screening with the study nurse. After mailing invitations to 1,348 patients, 104 patients were initially enrolled in the RCT of colon cancer screening. Of 952 patients who did not respond to the initial mailed invitation, we randomly allocated 480 to follow-up invitation by telephone and 472 to follow-up invitation by mail. Attendance for eligibility screening with the study nurse was more frequent when non-responders were followed-up by telephone (84/480, 17.5%) than by mail (43/472, 9.1%) (relative risk (RR) 1.92, 95% confidence interval (CI) 1.36 to 2.71, P < 0.001). Enrollment into the RCT was also greater among patients followed-up by telephone (59/480, 12.3%) compared to those followed-up by mail (35/472, 7.4%) (RR 1.66, 95% CI 1.11 to 2.47, P=0.01). Telephone-based follow-up results in greater enrollment compared to a mail-based method. Our findings should be of interest to investigators conducting RCTs, particularly trials of screening interventions involving asymptomatic participants for which volunteer participation may be challenging. Clinicaltrials.gov NCT00865527.

Conic Sampling: An Efficient Method for Solving Linear and Quadratic Programming by Randomly Linking Constraints within the Interior

PubMed Central

Serang, Oliver

2012-01-01

Linear programming (LP) problems are commonly used in analysis and resource allocation, frequently surfacing as approximations to more difficult problems. Existing approaches to LP have been dominated by a small group of methods, and randomized algorithms have not enjoyed popularity in practice. This paper introduces a novel randomized method of solving LP problems by moving along the facets and within the interior of the polytope along rays randomly sampled from the polyhedral cones defined by the bounding constraints. This conic sampling method is then applied to randomly sampled LPs, and its runtime performance is shown to compare favorably to the simplex and primal affine-scaling algorithms, especially on polytopes with certain characteristics. The conic sampling method is then adapted and applied to solve a certain quadratic program, which compute a projection onto a polytope; the proposed method is shown to outperform the proprietary software Mathematica on large, sparse QP problems constructed from mass spectometry-based proteomics. PMID:22952741

United Kingdom transient ischaemic attack (UK-TIA) aspirin trial: interim results

PubMed Central

1988-01-01

From 1979 to 1985, 2435 patients thought to have had a transient ischaemic attack or minor ischaemic stroke were allocated at random to receive long term blind treatment with either aspirin 600 mg twice daily (n=815), aspirin 300 mg once daily (806), or placebo (814). Treatment continued with about 85% compliance until September 1986 (mean four years). The odds of suffering one or more of four categories of event—namely, non-fatal myocardial infarction, non-fatal major stroke, vascular death, or non-vascular death—were 18% less in the two groups allocated to receive aspirin than in the group allocated to receive placebo (2p=0·01). The more relevant but less frequent composite event of disabling stroke or vascular death was reduced by only 7%; this reduction was not significantly different from zero, but nor was it significantly different from a 25% reduction. There was no definite difference between responses to the 300 mg and 1200 mg daily doses, except that the lower dose was significantly less gastrotoxic. PMID:2894232

Time pressure and attention allocation effect on upper limb motion steadiness.

PubMed

Liu, Sicong; Eklund, Robert C; Tenenbaum, Gershon

2015-01-01

Following ironic process theory (IPT), the authors aimed at investigating how attentional allocation affects participants' upper limb motion steadiness under low and high levels of mental load. A secondary purpose was to examine the validity of skin conductance level in measuring perception of pressure. The study consisted of 1 within-participant factor (i.e., phase: baseline, test) and 4 between-participant factors (i.e., gender: male, female; mental load: fake time constraints, no time constraints; attention: positive, suppressive; order: baseline → → → test, test → → baseline). Eighty college students (40 men and 40 women, Mage = 20.20 years, SD(age) = 1.52 years) participated in the study. Gender-stratified random assignment was employed in a 2 × 2 × 2 × 2 × 2 mixed experimental design. The findings generally support IPT but its predictions on motor performance under mental load may not be entirely accurate. Unlike men, women's performance was not susceptible to manipulations of mental load and attention allocation. The validity of skin conductance readings as an index of pressure perception was called into question.

A person based formula for allocating commissioning funds to general practices in England: development of a statistical model

PubMed Central

Smith, Peter; Gravelle, Hugh; Martin, Steve; Bardsley, Martin; Rice, Nigel; Georghiou, Theo; Dusheiko, Mark; Billings, John; Lorenzo, Michael De; Sanderson, Colin

2011-01-01

Objectives To develop a formula for allocating resources for commissioning hospital care to all general practices in England based on the health needs of the people registered in each practice Design Multivariate prospective statistical models were developed in which routinely collected electronic information from 2005-6 and 2006-7 on individuals and the areas in which they lived was used to predict their costs of hospital care in the next year, 2007-8. Data on individuals included all diagnoses recorded at any inpatient admission. Models were developed on a random sample of 5 million people and validated on a second random sample of 5 million people and a third sample of 5 million people drawn from a random sample of practices. Setting All general practices in England as of 1 April 2007. All NHS inpatient admissions and outpatient attendances for individuals registered with a general practice on that date. Subjects All individuals registered with a general practice in England at 1 April 2007. Main outcome measures Power of the statistical models to predict the costs of the individual patient or each practice’s registered population for 2007-8 tested with a range of metrics (R2 reported here). Comparisons of predicted costs in 2007-8 with actual costs incurred in the same year were calculated by individual and by practice. Results Models including person level information (age, sex, and ICD-10 codes diagnostic recorded) and a range of area level information (such as socioeconomic deprivation and supply of health facilities) were most predictive of costs. After accounting for person level variables, area level variables added little explanatory power. The best models for resource allocation could predict upwards of 77% of the variation in costs at practice level, and about 12% at the person level. With these models, the predicted costs of about a third of practices would exceed or undershoot the actual costs by 10% or more. Smaller practices were more likely to be in these groups. Conclusions A model was developed that performed well by international standards, and could be used for allocations to practices for commissioning. The best formulas, however, could predict only about 12% of the variation in next year’s costs of most inpatient and outpatient NHS care for each individual. Person-based diagnostic data significantly added to the predictive power of the models. PMID:22110252

Development of an E-learning System for the Endoscopic Diagnosis of Early Gastric Cancer: An International Multicenter Randomized Controlled Trial.

PubMed

Yao, K; Uedo, N; Muto, M; Ishikawa, H; Cardona, H J; Filho, E C Castro; Pittayanon, R; Olano, C; Yao, F; Parra-Blanco, A; Ho, S H; Avendano, A G; Piscoya, A; Fedorov, E; Bialek, A P; Mitrakov, A; Caro, L; Gonen, C; Dolwani, S; Farca, A; Cuaresma, L F; Bonilla, J J; Kasetsermwiriya, W; Ragunath, K; Kim, S E; Marini, M; Li, H; Cimmino, D G; Piskorz, M M; Iacopini, F; So, J B; Yamazaki, K; Kim, G H; Ang, T L; Milhomem-Cardoso, D M; Waldbaum, C A; Carvajal, W A Piedra; Hayward, C M; Singh, R; Banerjee, R; Anagnostopoulos, G K; Takahashi, Y

2016-07-01

In many countries, gastric cancer is not diagnosed until an advanced stage. An Internet-based e-learning system to improve the ability of endoscopists to diagnose gastric cancer at an early stage was developed and was evaluated for its effectiveness. The study was designed as a randomized controlled trial. After receiving a pre-test, participants were randomly allocated to either an e-learning or non-e-learning group. Only those in the e-learning group gained access to the e-learning system. Two months after the pre-test, both groups received a post-test. The primary endpoint was the difference between the two groups regarding the rate of improvement of their test results. 515 endoscopists from 35 countries were assessed for eligibility, and 332 were enrolled in the study, with 166 allocated to each group. Of these, 151 participants in the e-learning group and 144 in the non-e-learning group were included in the analysis. The mean improvement rate (standard deviation) in the e-learning and non-e-learning groups was 1·24 (0·26) and 1·00 (0·16), respectively (P<0·001). This global study clearly demonstrated the efficacy of an e-learning system to expand knowledge and provide invaluable experience regarding the endoscopic detection of early gastric cancer (R000012039). Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Rehabilitation of Executive Functions in Patients with Chronic Acquired Brain Injury with Goal Management Training, External Cuing, and Emotional Regulation: A Randomized Controlled Trial.

PubMed

Tornås, Sveinung; Løvstad, Marianne; Solbakk, Anne-Kristin; Evans, Jonathan; Endestad, Tor; Hol, Per Kristian; Schanke, Anne-Kristine; Stubberud, Jan

2016-04-01

Executive dysfunction is a common consequence of acquired brain injury (ABI), causing significant disability in daily life. This randomized controlled trial investigated the efficacy of Goal Management Training (GMT) in improving executive functioning in patients with chronic ABI. Seventy patients with a verified ABI and executive dysfunction were randomly allocated to GMT (n=33) or a psycho-educative active control condition, Brain Health Workshop (BHW) (n=37). In addition, all participants received external cueing by text messages. Neuropsychological tests and self-reported questionnaires of executive functioning were administered pre-intervention, immediately after intervention, and at 6 months follow-up. Assessors were blinded to group allocation. Questionnaire measures indicated significant improvement of everyday executive functioning in the GMT group, with effects lasting at least 6 months post-treatment. Both groups improved on the majority of the applied neuropsychological tests. However, improved performance on tests demanding executive attention was most prominent in the GMT group. The results indicate that GMT combined with external cueing is an effective metacognitive strategy training method, ameliorating executive dysfunction in daily life for patients with chronic ABI. The strongest effects were seen on self-report measures of executive functions 6 months post-treatment, suggesting that strategies learned in GMT were applied and consolidated in everyday life after the end of training. Furthermore, these findings show that executive dysfunction can be improved years after the ABI.

Embryo Transfer Catheters: Softer is Easier.

PubMed

Ruhlmann, Claudio; Gnocchi, Diego C; Cattaneo, Antonio R; Molina, Lucas G; Rivadeneira, Luciano Ruiz; Tessari, Lautaro; Martínez, Alejandro G

2015-11-01

This study aimed to compare the use of semi-rigid and flexible catheters in terms of pregnancy rate and level of difficulty of the embryo transfer (ET) procedure. Seven hundred and thirty-nine consecutive follicular aspirations for IVF or ICSI performed in our private fertility clinic within a 30-month period were randomly divided into two groups. Patients were allocated to either of the groups at the time of follicular retrieval with the aid of a random number generator according to the catheter used in ET: Group 1 (n = 370) - Frydman Classic Catheter 4.5 catheters; and Group 2 (n = 369) - Frydman Ultrasoft 4.5 catheters. Only patients offered ET in the randomized cycle were included (Group 1 = 363 and Group 2 = 340). Patients did not change groups after catheter allocation. Statistical analysis was carried out using an unpaired t-test or a chi square test as appropriate. Differences with P<0.05 were considered. A statistically significant difference in favor of the use of the Ultrasoft catheter was evident for parameters use of a tenaculum (19.8% vs. 5.9%) or a hysterometer (5.0% vs. 1.2%), presence of blood during post-ET inspection of the catheter (9.9% vs. 3.8%), and implantation rate (13.0% vs. 16.4%). Clinical pregnancy and delivery rates were comparable in both groups. Our results suggest that a softer catheter may help with difficult ETs. Softer catheters, as also reported by other authors, resulted in better implantation rates.

Deficiencies of effectiveness of intervention studies in veterinary medicine: a cross-sectional survey of ten leading veterinary and medical journals

PubMed Central

Meursinge Reynders, Reint

2016-01-01

The validity of studies that assess the effectiveness of an intervention (EoI) depends on variables such as the type of study design, the quality of their methodology, and the participants enrolled. Five leading veterinary journals and 5 leading human medical journals were hand-searched for EoI studies for the year 2013. We assessed (1) the prevalence of randomized controlled trials (RCTs) among EoI studies, (2) the type of participants enrolled, and (3) the methodological quality of the selected studies. Of 1707 eligible articles, 590 were EoI articles and 435 RCTs. Random allocation to the intervention was performed in 52% (114/219; 95%CI:45.2–58.8%) of veterinary EoI articles, against 87% (321/371; 82.5–89.7%) of human EoI articles (adjusted OR:9.2; 3.4–24.8). Veterinary RCTs were smaller (median: 26 animals versus 465 humans) and less likely to enroll real patients, compared with human RCTs (OR:331; 45–2441). Only 2% of the veterinary RCTs, versus 77% of the human RCTs, reported power calculations, primary outcomes, random sequence generation, allocation concealment and estimation methods. Currently, internal and external validity of veterinary EoI studies is limited compared to human medical ones. To address these issues, veterinary interventional research needs to improve its methodology, increase the number of published RCTs and enroll real clinical patients. PMID:26835187

Investigating the relationship between predictability and imbalance in minimisation: a simulation study

PubMed Central

2013-01-01

Background The use of restricted randomisation methods such as minimisation is increasing. This paper investigates under what conditions it is preferable to use restricted randomisation in order to achieve balance between treatment groups at baseline with regard to important prognostic factors and whether trialists should be concerned that minimisation may be considered deterministic. Methods Using minimisation as the randomisation algorithm, treatment allocation was simulated for hypothetical patients entering a theoretical study having values for prognostic factors randomly assigned with a stipulated probability. The number of times the allocation could have been determined with certainty and the imbalances which might occur following randomisation using minimisation were examined. Results Overall treatment balance is relatively unaffected by reducing the probability of allocation to optimal treatment group (P) but within-variable balance can be affected by any P <1. This effect is magnified by increased numbers of prognostic variables, the number of categories within them and the prevalence of these categories within the study population. Conclusions In general, for smaller trials, probability of treatment allocation to the treatment group with fewer numbers requires a larger value P to keep treatment and variable groups balanced. For larger trials probability of allocation values from P = 0.5 to P = 0.8 can be used while still maintaining balance. For one prognostic variable there is no significant benefit in terms of predictability in reducing the value of P. However, for more than one prognostic variable, significant reduction in levels of predictability can be achieved with the appropriate choice of P for the given trial design. PMID:23537389

Investigating the relationship between predictability and imbalance in minimisation: a simulation study.

PubMed

McPherson, Gladys C; Campbell, Marion K; Elbourne, Diana R

2013-03-27

The use of restricted randomisation methods such as minimisation is increasing. This paper investigates under what conditions it is preferable to use restricted randomisation in order to achieve balance between treatment groups at baseline with regard to important prognostic factors and whether trialists should be concerned that minimisation may be considered deterministic. Using minimisation as the randomisation algorithm, treatment allocation was simulated for hypothetical patients entering a theoretical study having values for prognostic factors randomly assigned with a stipulated probability. The number of times the allocation could have been determined with certainty and the imbalances which might occur following randomisation using minimisation were examined. Overall treatment balance is relatively unaffected by reducing the probability of allocation to optimal treatment group (P) but within-variable balance can be affected by any P <1. This effect is magnified by increased numbers of prognostic variables, the number of categories within them and the prevalence of these categories within the study population. In general, for smaller trials, probability of treatment allocation to the treatment group with fewer numbers requires a larger value P to keep treatment and variable groups balanced. For larger trials probability of allocation values from P = 0.5 to P = 0.8 can be used while still maintaining balance. For one prognostic variable there is no significant benefit in terms of predictability in reducing the value of P. However, for more than one prognostic variable, significant reduction in levels of predictability can be achieved with the appropriate choice of P for the given trial design.

Learning automata-based solutions to the nonlinear fractional knapsack problem with applications to optimal resource allocation.

PubMed

Granmo, Ole-Christoffer; Oommen, B John; Myrer, Svein Arild; Olsen, Morten Goodwin

2007-02-01

This paper considers the nonlinear fractional knapsack problem and demonstrates how its solution can be effectively applied to two resource allocation problems dealing with the World Wide Web. The novel solution involves a "team" of deterministic learning automata (LA). The first real-life problem relates to resource allocation in web monitoring so as to "optimize" information discovery when the polling capacity is constrained. The disadvantages of the currently reported solutions are explained in this paper. The second problem concerns allocating limited sampling resources in a "real-time" manner with the purpose of estimating multiple binomial proportions. This is the scenario encountered when the user has to evaluate multiple web sites by accessing a limited number of web pages, and the proportions of interest are the fraction of each web site that is successfully validated by an HTML validator. Using the general LA paradigm to tackle both of the real-life problems, the proposed scheme improves a current solution in an online manner through a series of informed guesses that move toward the optimal solution. At the heart of the scheme, a team of deterministic LA performs a controlled random walk on a discretized solution space. Comprehensive experimental results demonstrate that the discretization resolution determines the precision of the scheme, and that for a given precision, the current solution (to both problems) is consistently improved until a nearly optimal solution is found--even for switching environments. Thus, the scheme, while being novel to the entire field of LA, also efficiently handles a class of resource allocation problems previously not addressed in the literature.

Methodological reporting of randomized trials in five leading Chinese nursing journals.

PubMed

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.

Prophylactic antibiotics for the prevention of cellulitis (erysipelas) of the leg: results of the UK Dermatology Clinical Trials Network's PATCH II trial.

PubMed

Thomas, Kim; Crook, Angela; Foster, Katharine; Mason, James; Chalmers, Joanne; Bourke, John; Ferguson, Adam; Level, Nick; Nunn, Andrew; Williams, Hywel

2012-01-01

Cellulitis (erysipelas) of the leg is a common, painful infection of the skin and underlying tissue. Repeat episodes are frequent, cause significant morbidity and result in high health service costs. To assess whether prophylactic antibiotics prescribed after an episode of cellulitis of the leg can prevent further episodes. Double-blind, randomized controlled trial including patients recently treated for an episode of leg cellulitis. Recruitment took place in 20 hospitals. Randomization was by computer-generated code, and treatments allocated by post from a central pharmacy. Participants were enrolled for a maximum of 3 years and received their randomized treatment for the first 6 months of this period. Participants (n=123) were randomized (31% of target due to slow recruitment). The majority (79%) had suffered one episode of cellulitis on entry into the study. The primary outcome of time to recurrence of cellulitis included all randomized participants and was blinded to treatment allocation. The hazard ratio (HR) showed that treatment with penicillin reduced the risk of recurrence by 47% [HR 0·53, 95% confidence interval (CI) 0·26-1·07, P=0·08]. In the penicillin V group 12/60 (20%) had a repeat episode compared with 21/63 (33%) in the placebo group. This equates to a number needed to treat (NNT) of eight participants in order to prevent one repeat episode of cellulitis [95% CI NNT(harm) 48 to ∞ to NNT(benefit) 3]. We found no difference between the two groups in the number of participants with oedema, ulceration or related adverse events. Although this trial was limited by slow recruitment, and the result failed to achieve statistical significance, it provides the best evidence available to date for the prevention of recurrence of this debilitating condition. © 2011 The Authors. BJD © 2011 British Association of Dermatologists.

Clinical and Aesthetic Outcome with Post-Extractive Implants with or without Soft Tissue Augmentation: A 2-Year Randomized Clinical Trial.

PubMed

Migliorati, Marco; Amorfini, Leonardo; Signori, Alessio; Biavati, Armando Silvestrini; Benedicenti, Stefano

2015-10-01

The aesthetic outcome of an implant-supported restoration is first of all dependent on the soft tissue volume. Because the labial bone plate resorbs in every direction after tooth extraction, even when an implant is placed immediately, most patients end up with compromised aesthetics. In this parallel-designed, randomized clinical trial, participants were randomly assigned to the test group (immediate load post-extractive implant treated with subepithelial connective tissue graft placed using the tunnel technique in the labial area) and control group (immediate load post-extractive implant treated without raising a flap) with an allocation ratio of 1:1. Both groups received deproteinized bovine bone mineral. Patients were observed at baseline, crown insertion, 1-year follow-up, and 2-year follow-up. Clinical, radiological and aesthetic parameters were recorded to assess primary treatment outcomes. A random permuted block system was blindly generated ensuring uniformity of the patient allocation during the trial by randomly distributing three participants to the test and three participants to the control group every six treated patients. At the 2-year examination, all 47 implants were successfully integrated, demonstrating stability and healthy peri-implant soft tissues as documented by standard clinical parameters. The results showed a soft tissue remodeling of -10% in thickness and -18% in highness in the non-grafted group, whereas in the grafted group there was a gain of 35% in thickness and a slight reduction of -11% in highness. Test group reported an increase of aesthetic result (mean pink aesthetic score [PES] 8) compared with control group (mean PES 6.65). This prospective study demonstrates the effectiveness of placing a soft tissue graft at the time of immediate implant placement in the aesthetic zone. At the 2-year follow-up, test group revealed a better aesthetic outcomes and stable facial soft tissues compared with control group. © 2013 Wiley Periodicals, Inc.

Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial.

PubMed

Al-Sibaie, Salma; Hajeer, Mohammad Y

2014-06-01

No randomized controlled trial has tried to compare treatment outcomes between the sliding en-masse retraction of upper anterior teeth supported by mini-implants and the two-step sliding retraction technique employing conventional anchorage devices. To evaluate skeletal, dental, and soft tissue changes following anterior teeth retraction. Parallel-groups randomized controlled trial on patients with class II division 1 malocclusion treated at the University of Al-Baath Dental School in Hamah, Syria between July 2011 and May 2013. One hundred and thirty-three patients with an upper dentoalveolar protrusion were evaluated and 80 patients fulfilled the inclusion criteria. Randomization was performed using computer-generated tables; allocation was concealed using sequentially numbered opaque and sealed envelopes. Fifty-six participants were analysed (mean age 22.34 ± 4.56 years). They were randomly distributed into two groups with 28 patients in each group (1:1 allocation ratio). Following first premolar extraction, space closure was accomplished using either the en-masse technique with mini-implants or the two-step technique with transpalatal arches (TPAs). The antero-posterior displacements of upper incisal edges and upper first molars were measured on lateral cephalograms at three assessment times. Assessor blinding was employed. A bodily retraction (-4.42 mm; P < 0.001) with a slight intrusion (-1.53 mm; P < 0.001) of the upper anterior teeth was achieved in the mini-implants group, whereas upper anterior teeth retraction was achieved by controlled palatal tipping in the TPA group. When retracting anterior teeth in patients with moderate to severe protrusion, the en-masse retraction based on mini-implants anchorage gave superior results compared to the two-step retraction based on conventional anchorage in terms of speed, dental changes, anchorage loss, and aesthetic outcomes.

Proof of impact and pipeline planning: directions and challenges for social audit in the health sector.

PubMed

Andersson, Neil

2011-12-21

Social audits are typically observational studies, combining qualitative and quantitative uptake of evidence with consultative interpretation of results. This often falters on issues of causality because their cross-sectional design limits interpretation of time relations and separation out of other indirect associations.Social audits drawing on methods of randomised controlled cluster trials (RCCT) allow more certainty about causality. Randomisation means that exposure occurs independently of all events that precede it--it converts potential confounders and other covariates into random differences. In 2008, CIET social audits introduced randomisation of the knowledge translation component with subsequent measurement of impact in the changes introduced. This "proof of impact" generates an additional layer of evidence in a cost-effective way, providing implementation-ready solutions for planners.Pipeline planning is a social audit that incorporates stepped wedge RCCTs. From a listing of districts/communities as a sampling frame, individual entities (communities, towns, districts) are randomly assigned to waves of intervention. Measurement of the impact takes advantage of the delay occasioned by the reality that there are insufficient resources to implement everywhere at the same time. The impact in the first wave contrasts with the second wave, which in turn contrasts with a third wave, and so on until all have received the intervention. Provided care is taken to achieve reasonable balance in the random allocation of communities, towns or districts to the waves, the resulting analysis can be straightforward.Where there is sufficient management interest in and commitment to evidence, pipeline planning can be integrated in the roll-out of programmes where real time information can improve the pipeline. Not all interventions can be randomly allocated, however, and random differences can still distort measurement. Other issues include contamination of the subsequent waves, ambiguity of indicators, "participant effects" that result from lack of blinding and lack of placebos, ethics and, not least important, the skills to do pipeline planning correctly.

Proof of impact and pipeline planning: directions and challenges for social audit in the health sector

PubMed Central

2011-01-01

Social audits are typically observational studies, combining qualitative and quantitative uptake of evidence with consultative interpretation of results. This often falters on issues of causality because their cross-sectional design limits interpretation of time relations and separation out of other indirect associations. Social audits drawing on methods of randomised controlled cluster trials (RCCT) allow more certainty about causality. Randomisation means that exposure occurs independently of all events that precede it – it converts potential confounders and other covariates into random differences. In 2008, CIET social audits introduced randomisation of the knowledge translation component with subsequent measurement of impact in the changes introduced. This “proof of impact” generates an additional layer of evidence in a cost-effective way, providing implementation-ready solutions for planners. Pipeline planning is a social audit that incorporates stepped wedge RCCTs. From a listing of districts/communities as a sampling frame, individual entities (communities, towns, districts) are randomly assigned to waves of intervention. Measurement of the impact takes advantage of the delay occasioned by the reality that there are insufficient resources to implement everywhere at the same time. The impact in the first wave contrasts with the second wave, which in turn contrasts with a third wave, and so on until all have received the intervention. Provided care is taken to achieve reasonable balance in the random allocation of communities, towns or districts to the waves, the resulting analysis can be straightforward. Where there is sufficient management interest in and commitment to evidence, pipeline planning can be integrated in the roll-out of programmes where real time information can improve the pipeline. Not all interventions can be randomly allocated, however, and random differences can still distort measurement. Other issues include contamination of the subsequent waves, ambiguity of indicators, “participant effects” that result from lack of blinding and lack of placebos, ethics and, not least important, the skills to do pipeline planning correctly. PMID:22376386

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

PubMed

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

2001-10-01

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

Effectiveness of 3 methods of anchorage reinforcement for maximum anchorage in adolescents: A 3-arm multicenter randomized clinical trial.

PubMed

Sandler, Jonathan; Murray, Alison; Thiruvenkatachari, Badri; Gutierrez, Rodrigo; Speight, Paul; O'Brien, Kevin

2014-07-01

The objective of this 3-arm parallel randomized clinical trial was to compare the effectiveness of temporary anchorage devices (TADs), Nance button palatal arches, and headgear for anchorage supplementation in the treatment of patients with malocclusions that required maximum anchorage. This trial was conducted between August 2008 and February 2013 in 2 orthodontic departments in the United Kingdom. The study included 78 patients (ages, 12-18 years; mean age, 14.2 years) who needed maximum anchorage. Eligibility criteria included no active caries, exemplary oral hygiene, and maximum anchorage required. The primary outcome was mesial molar movement during the period in which anchorage supplementation was required. The secondary outcomes were duration of anchorage reinforcement, number of treatment visits, number of casual and failed appointments, total treatment time, dento-occlusal change, and patients' perceptions of the method of anchorage supplementation. Treatment allocation was implemented by contacting via the Internet the randomization center at the University of Nottingham, Clinical Trials Unit. The randomization was based on a computer-generated pseudo-random code with random permuted blocks of randomly varying size. A research assistant who was blinded to the group allocation recorded all data. The patients were randomly allocated to receive anchorage supplementation with TADs, a Nance button on a palatal arch, or headgear. They were all treated with maxillary and mandibular preadjusted edgewise fixed appliances with 0.022-in slot prescription brackets. They were followed until orthodontic treatment was complete. Seventy-eight patients were randomized in a 1:1:1 ratio among the 3 groups. The baseline characteristics were similar in the groups, and they were treated for an average of 27.4 months (SD, 7.1 months); 71 completed orthodontic treatment. The data were analyzed on a per-protocol basis and showed no differences in the effectiveness of anchorage supplementation between TADs, Nance button palatal arches, and headgear. Compared with headgear, the average mesial movements of the maxillary right molar were 0.62 mm (-0.32 to 1.55 mm) with the Nance and -0.58 mm (-1.53 to 0.36 mm) with TADs; the maxillary left molar was moved -0.09 mm (-1.00 to 0.83 mm) with the Nance and -0.96 mm (-1.89 to -0.04 mm) with the TADs. Peer assessment rating scores were significantly better with the TADs than in the headgear and Nance groups. The patient questionnaires showed that comfort levels on placement of the TADs and the Nance were similar. Headgear was more troublesome and less popular with the patients. There was no difference in the effectiveness between the 3 groups in terms of anchorage support. There were more problems with the headgear and Nance buttons than with the TADs. The quality of treatment was better with TADs. As a result, TADS might be the preferred method for reinforcing orthodontic anchorage in patients who need maximum anchorage. ClinicalTrials.gov Identifier: NCT00995436. The protocol was published on the above site before the trial commencement. The British Orthodontic Society Foundation funded the study and American Orthodontics provided all the TADs and associated equipment. Copyright © 2014 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Mitigating wildland fire hazard using complex network centrality measures

NASA Astrophysics Data System (ADS)

Russo, Lucia; Russo, Paola; Siettos, Constantinos I.

2016-12-01

We show how to distribute firebreaks in heterogeneous forest landscapes in the presence of strong wind using complex network centrality measures. The proposed framework is essentially a two-tire one: at the inner part a state-of- the-art Cellular Automata model is used to compute the weights of the underlying lattice network while at the outer part the allocation of the fire breaks is scheduled in terms of a hierarchy of centralities which influence the most the spread of fire. For illustration purposes we applied the proposed framework to a real-case wildfire that broke up in Spetses Island, Greece in 1990. We evaluate the scheme against the benchmark of random allocation of firebreaks under the weather conditions of the real incident i.e. in the presence of relatively strong winds.

Publication bias in animal research presented at the 2008 Society of Critical Care Medicine Conference.

PubMed

Conradi, Una; Joffe, Ari R

2017-07-07

To determine a direct measure of publication bias by determining subsequent full-paper publication (P) of studies reported in animal research abstracts presented at an international conference (A). We selected 100 random (using a random-number generator) A from the 2008 Society of Critical Care Medicine Conference. Using a data collection form and study manual, we recorded methodology and result variables from A. We searched PubMed and EMBASE to June 2015, and DOAJ and Google Scholar to May 2017 to screen for subsequent P. Methodology and result variables were recorded from P to determine changes in reporting from A. Predictors of P were examined using Fisher's Exact Test. 62% (95% CI 52-71%) of studies described in A were subsequently P after a median 19 [IQR 9-33.3] months from conference presentation. Reporting of studies in A was of low quality: randomized 27% (the method of randomization and allocation concealment not described), blinded 0%, sample-size calculation stated 0%, specifying the primary outcome 26%, numbers given with denominators 6%, and stating number of animals used 47%. Only being an orally presented (vs. poster presented) A (14/16 vs. 48/84, p = 0.025) predicted P. Reporting of studies in P was of poor quality: randomized 39% (the method of randomization and allocation concealment not described), likely blinded 6%, primary outcome specified 5%, sample size calculation stated 0%, numbers given with denominators 34%, and number of animals used stated 56%. Changes in reporting from A to P occurred: from non-randomized to randomized 19%, from non-blinded to blinded 6%, from negative to positive outcomes 8%, from having to not having a stated primary outcome 16%, and from non-statistically to statistically significant findings 37%. Post-hoc, using publication data, P was predicted by having positive outcomes (published 62/62, unpublished 33/38; p = 0.003), or statistically significant results (published 58/62, unpublished 20/38; p < 0.001). Only 62% (95% CI 52-71%) of animal research A are subsequently P; this was predicted by oral presentation of the A, finally having positive outcomes, and finally having statistically significant results. Publication bias is prevalent in critical care animal research.

Population screening and intervention for vascular disease in Danish men (VIVA): a randomised controlled trial.

PubMed

Lindholt, Jes S; Søgaard, Rikke

2017-11-18

Abdominal aortic aneurysm is the only cardiovascular disease targeted by population screening. In this study, we test the effect of screening and subsequent intervention for abdominal aortic aneurysm, peripheral arterial disease, and hypertension combined. In this randomised controlled trial, we randomly allocated (1:1) all men aged 65-74 years living in the Central Denmark Region to screening for abdominal aortic aneurysm, peripheral arterial disease, and hypertension, or to no screening. We based allocation on computer-generated random numbers from 1 to 100 in blocks of 1067 to 4392, stratified by 19 municipalities. Only the non-screening group and the investigator assessing outcomes were masked. We invited participants who were found to have abdominal aortic aneurysm or peripheral arterial disease back for confirmation and eventual initiation of relevant pharmacological therapy. We further offered participants with abdominal aortic aneurysm annual control or surgical repair. We referred participants with suspected hypertension to their general practitioner. The primary outcome was all-cause mortality, assessed 5 years after randomisation, analysed in all randomly allocated participants except for those who had incorrect person identification numbers. This trial is registered at ClinicalTrials.gov, number NCT00662480. Between Oct 8, 2008, and Jan 11, 2011, we randomly allocated 50 156 participants, with 25 078 (50%) each in the screening and non-screening groups. Four (<1%) participants in the screening group were lost to follow-up. After a median follow-up of 4·4 years (IQR 3·9-4·8), 2566 (10·2%) of 25 074 participants in the screening group and 2715 (10·8%) of 25 078 in the non-screening group had died. This finding resulted in a significant hazard ratio of 0·93 (95% CI 0·88-0·98; p=0·01), an absolute risk reduction of 0·006 (0·001-0·011), and a number needed to invite of 169 (89-1811). Incidences of diabetes (3995 per 100 000 person-years in the screening group vs 4129 per 100 000 person-years in the non-screening group), intracerebral haemorrhage (146 vs 140), renal failure (612 vs 649), cancer (3578 vs 3719), or 30 day mortality after cardiovascular surgery (44·57 vs 39·33) did not differ between groups. The observed reduction of mortality risk from abdominal aortic aneurysm, peripheral arterial disease, and hypertension has never been seen before in the population screening literature and can be linked primarily to initiation of pharmacological therapy. Health policy makers should consider implementing combined screening whether no screening or isolated abdominal aortic aneurysm screening is currently offered. The 7th European Framework Programme, Central Denmark Region, Viborg Hospital, and the Danish Council for Independent Research. Copyright © 2017 Elsevier Ltd. All rights reserved.

CREB regulates memory allocation in the insular cortex

PubMed Central

Sano, Yoshitake; Shobe, Justin L.; Zhou, Miou; Huang, Shan; Shuman, Tristan; Cai, Denise J.; Golshani, Peyman; Kamata, Masakazu; Silva, Alcino J.

2016-01-01

Summary The molecular and cellular mechanisms of memory storage have attracted a great deal of attention. By comparison, little is known about memory allocation, the process that determines which specific neurons in a neural network will store a given memory [1, 2]. Previous studies demonstrated that memory allocation is not random in the amygdala; these studies showed that amygdala neurons with higher levels of the cAMP response element binding protein (CREB) are more likely to be recruited into encoding and storing fear memory [3–6]. To determine whether specific mechanisms also regulate memory allocation in other brain regions, and whether CREB also has a role in this process, we studied insular cortical memory representations for conditioned taste aversion (CTA). In this task, an animal learns to associate a taste (CS) with the experience of malaise (such as that induced by LiCl; US). The insular cortex is required for CTA memory formation and retrieval [7–12]. CTA learning activates a subpopulation of neurons in this structure [13–15], and the insular cortex and the basolateral amygdala (BLA) interact during CTA formation [16, 17]. Here, we used a combination of approaches, including viral vector transfections of insular cortex, arc Fluorescence In Situ Hybridization (FISH) and Designer Receptors Exclusively Activated by Designer Drugs (DREADD) system, to show that CREB levels determine which insular cortical neurons go on to encode a given conditioned taste memory. PMID:25454591

Effects of Study Design and Allocation on participant behaviour--ESDA: study protocol for a randomized controlled trial.

PubMed

Kypri, Kypros; McCambridge, Jim; Wilson, Amanda; Attia, John; Sheeran, Paschal; Bowe, Steve; Vater, Tina

2011-02-14

What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study design and allocation on participant drinking behaviour. A three-arm parallel group randomised controlled trial design will be used. All recruitment, screening, randomisation, and follow-up will be conducted on-line among university students. Participants who indicate a hazardous level of alcohol consumption will be randomly assigned to one of three groups. Group A will be informed their drinking will be assessed at baseline and again in one month (as in a cohort study design). Group B will be told the study is an intervention trial and they are in the control group. Group C will be told the study is an intervention trial and they are in the intervention group. All will receive exactly the same brief educational material to read. After one month, alcohol intake for the past 4 weeks will be assessed. The experimental manipulations address subtle and previously unexplored ways in which participant behaviour may be unwittingly influenced by standard practice in trials. Given the necessity of relying on self-reported outcome, it will not be possible to distinguish true behaviour change from reporting artefact. This does not matter in the present study, as any effects of awareness of study design or allocation involve bias that is not well understood. There has been little research on awareness effects, and our outcomes will provide an indication of the possible value of further studies of this type and inform hypothesis generation. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000846022.

One and done? Equality of opportunity and repeated access to scarce, indivisible medical resources

PubMed Central

2012-01-01

Background Existing ethical guidelines recommend that, all else equal, past receipt of a medical resource (e.g. a scarce organ) should not be considered in current allocation decisions (e.g. a repeat transplantation). Discussion One stated reason for this ethical consensus is that formal theories of ethics and justice do not persuasively accept or reject repeated access to the same medical resources. Another is that restricting attention to past receipt of a particular medical resource seems arbitrary: why couldn’t one just as well, it is argued, consider receipt of other goods such as income or education? In consequence, simple allocation by lottery or first-come-first-served without consideration of any past receipt is thought to best afford equal opportunity, conditional on equal medical need. There are three issues with this view that need to be addressed. First, public views and patient preferences are less ambiguous than formal theories of ethics. Empirical work shows strong preferences for fairness in health care that have not been taken into account: repeated access to resources has been perceived as unfair. Second, while difficult to consider receipt of many other prior resources including non-medical resources, this should not be used a motive for ignoring the receipt of any and all goods including the focal resource in question. Third, when all claimants to a scarce resource are equally deserving, then use of random allocation seems warranted. However, the converse is not true: mere use of a randomizer does not by itself make the merits of all claimants equal. Summary My conclusion is that not ignoring prior receipt of the same medical resource, and prioritizing those who have not previously had access to the medical resource in question, may be perceived as fairer and more equitable by society. PMID:22624597

Early rehabilitation after total knee replacement surgery: a multicenter, noninferiority, randomized clinical trial comparing a home exercise program with usual outpatient care.

PubMed

Han, Annie S Y; Nairn, Lillias; Harmer, Alison R; Crosbie, Jack; March, Lyn; Parker, David; Crawford, Ross; Fransen, Marlene

2015-02-01

To determine, at 6 weeks postsurgery, if a monitored home exercise program (HEP) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement (TKR) surgery for osteoarthritis. We conducted a multicenter, randomized clinical trial. Patients ages 45-75 years were allocated at the time of hospital discharge to usual care rehabilitation (n = 196) or the HEP (n = 194). Outcomes assessed 6 weeks after surgery included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales, knee range of motion, and the 50-foot walk time. The upper bound of the 95% confidence interval (95% CI) mean difference favoring usual care was used to determine noninferiority. At 6 weeks after surgery there were no significant differences between usual care and HEP, respectively, for pain (7.4 and 7.2; 95% CI mean difference [MD] -0.7, 0.9), physical function (22.5 and 22.4; 95% CI MD -2.5, 2.6), knee flexion (96° and 97°; 95% CI MD -4°, 2°), knee extension (-7° and -6°; 95% CI MD -2°, 1°), or the 50-foot walk time (12.9 and 12.9 seconds; 95% CI MD -0.8, 0.7 seconds). At 6 weeks, 18 patients (9%) allocated to usual care and 11 (6%) to the HEP did not achieve 80° knee flexion. There was no difference between the treatment allocations in the number of hospital readmissions. The HEP was not inferior to usual care as an early rehabilitation protocol after primary TKR. Copyright © 2015 by the American College of Rheumatology.

One and done? Equality of opportunity and repeated access to scarce, indivisible medical resources.

PubMed

Huesch, Marco D

2012-05-24

Existing ethical guidelines recommend that, all else equal, past receipt of a medical resource (e.g. a scarce organ) should not be considered in current allocation decisions (e.g. a repeat transplantation). One stated reason for this ethical consensus is that formal theories of ethics and justice do not persuasively accept or reject repeated access to the same medical resources. Another is that restricting attention to past receipt of a particular medical resource seems arbitrary: why couldn't one just as well, it is argued, consider receipt of other goods such as income or education? In consequence, simple allocation by lottery or first-come-first-served without consideration of any past receipt is thought to best afford equal opportunity, conditional on equal medical need.There are three issues with this view that need to be addressed. First, public views and patient preferences are less ambiguous than formal theories of ethics. Empirical work shows strong preferences for fairness in health care that have not been taken into account: repeated access to resources has been perceived as unfair. Second, while difficult to consider receipt of many other prior resources including non-medical resources, this should not be used a motive for ignoring the receipt of any and all goods including the focal resource in question. Third, when all claimants to a scarce resource are equally deserving, then use of random allocation seems warranted. However, the converse is not true: mere use of a randomizer does not by itself make the merits of all claimants equal. My conclusion is that not ignoring prior receipt of the same medical resource, and prioritizing those who have not previously had access to the medical resource in question, may be perceived as fairer and more equitable by society.

Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records.

PubMed

Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C; Trial Steering Committee

2014-07-01

The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810. © 2014 American Heart Association, Inc.

An Experimental Study of Effects on Schoolchildren of Exposure to Point-of-Sale Cigarette Advertising and Pack Displays

ERIC Educational Resources Information Center

Wakefield, Melanie; Germain, Daniella; Durkin, Sarah; Henriksen, Lisa

2006-01-01

By creating a sense of familiarity with tobacco, cigarette advertising and bold packaging displays in stores where children often visit may help to pre-dispose them to smoking. A total of 605 ninth-grade students were randomly allocated to view a photograph of a typical convenience store point-of-sale which had been digitally manipulated to show…

Practice Makes Poorer: Practice Gambling Modes and Their Effects on Real-Play in Simulated Roulette

ERIC Educational Resources Information Center

Bednarz, Jana; Delfabbro, Paul; King, Daniel

2013-01-01

The aim of this study was to examine the role of free-play modes on gambling behaviour in computer-based roulette. Eighty participants were randomly allocated to one of four pre-exposure conditions: no exposure (control group), a loss condition, a break-even and a profit condition in which the return to player was greater than 100%. Behavioural…

Testing for Near and Far Transfer Effects with a Short, Face-to-Face Adaptive Working Memory Training Intervention in Typical Children

ERIC Educational Resources Information Center

Henry, Lucy A.; Messer, David J.; Nash, Gilly

2014-01-01

A relatively quick, face-to-face, adaptive working memory training intervention was assessed in 5-to 8-year-old typically developing children, randomly allocated to a 6-week intervention condition, or an active control condition. All children received 18 sessions of 10?minutes, three times/week for 6?weeks. Assessments of six working memory…

Camelina meal supplementation to beef cattle: I. Effects on performance, DMI, and acute-phase protein response of feeder steers following transport

USDA-ARS?s Scientific Manuscript database

Sixty Angus x Hereford steers were ranked by BW on d -28 of the study and allocated to 20 drylot pens which were randomly assigned to receive: 1) supplement containing (as-fed basis) 84% corn, 14% soybean meal, and 2% mineral mix (CO) offered during preconditioning (PC; d -28 to 0) and feedlot recei...

How Need-Based Financial Aid Reduces College Attrition among Low-Income Public University Students: The Role of Time Use

ERIC Educational Resources Information Center

Goldrick-Rab, Sara; Harris, Douglas N.; Benson, James

2011-01-01

The authors examine whether a need-based financial grant distribution "at random" to 1,500 Wisconsin Pell Grant recipients attending 13 public universities had an impact on how they allocated their time devoted to (a) working, (b) studying, (c) sleeping, and (d) socializing. To test whether time use mediates the relationship between aid…

The Effect of Text Messaging on 9- and 10-Year-Old Children's Reading, Spelling and Phonological Processing Skills

ERIC Educational Resources Information Center

Wood, C.; Jackson, E.; Hart, L.; Plester, B.; Wilde, L.

2011-01-01

This paper reports on an intervention study that considered the impact of text messaging on 9- to 10-year-old children's literacy skills. One hundred and fourteen children who had never owned a mobile phone before were recruited and randomly allocated to either the intervention or control conditions. All children were pre- and post-tested on a…

Differential Learning as a Key Training Approach to Improve Creative and Tactical Behavior in Soccer

ERIC Educational Resources Information Center

Santos, Sara; Coutinho, Diogo; Gonçalves, Bruno; Schöllhorn, Wolfgang; Sampaio, Jaime; Leite, Nuno

2018-01-01

Purpose: The aim of this study was to identify the effects of a differential-learning program, embedded in small-sided games, on the creative and tactical behavior of youth soccer players. Forty players from under-13 (U13) and under-15 (U15) were allocated into control and experimental groups and were tested using a randomized pretest to posttest…

Texting Your Way to Healthier Eating? Effects of Participating in a Feedback Intervention Using Text Messaging on Adolescents' Fruit and Vegetable Intake

ERIC Educational Resources Information Center

Pedersen, Susanne; Grønhøj, Alice; Thøgersen, John

2016-01-01

This study investigates the effects of a feedback intervention employing text messaging during 11 weeks on adolescents' behavior, self-efficacy and outcome expectations regarding fruit and vegetable intake. A pre- and post-survey was completed by 1488 adolescents school-wise randomly allocated to a control group and two experimental groups. Both…

The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.

PubMed

Wang, Gang; Mao, Bing; Xiong, Ze-Yu; Fan, Tao; Chen, Xiao-Dong; Wang, Lei; Liu, Guan-Jian; Liu, Jia; Guo, Jia; Chang, Jing; Wu, Tai-Xiang; Li, Ting-Qian

2007-07-01

The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004. Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus. Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%). The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.

[Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

PubMed

Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

2018-02-01

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions. Copyright© by the Chinese Pharmaceutical Association.

Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial.

PubMed

Buhagiar, Mark A; Naylor, Justine M; Harris, Ian A; Xuan, Wei; Kohler, Friedbert; Wright, Rachael J; Fortunato, Renee

2013-12-17

Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function. This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%.The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required. The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty. U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153.

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

PubMed

Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary

2010-06-01

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.

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

PubMed

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

2016-06-02

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

Pretreatment with remifentanil, fentanyl, or lidocaine to prevent withdrawal after rocuronium using venous occlusion technique in children and adolescents: a prospective randomized placebo-controlled double-blind study.

PubMed

Abu-Halaweh, S A; Aloweidi, A K; Qudaisat, I Y; Al-Hussami, M O; Al Zaben, K R; Abu-Halaweh, A S

2014-12-01

Pain caused by intravenous injection of the muscle relaxant rocuronium bromide is common in children and adolescents. The cause of this unwanted effect is still unclear, and different pretreatment drugs have been administered in attempts to alleviate this side effect, with varying degrees of success. This study used a 60-s venous occlusion technique to evaluate the effectiveness of pretreatment with lidocaine, fentanyl, or remifentanil in preventing pain-induced withdrawal caused by intravenous injection of rocuronium bromide during the induction of general anesthesia. One hundred and one child and adolescent patients, ASA Ι-II, requiring various surgical procedures under general anesthesia with muscle relaxation and mechanical ventilation, were enrolled. Patients were allocated randomly using computer-generated randomization into one of four pretreatment groups: a remifentanil group (1 µg/kg, n = 25), fentanyl group (1 µg/kg, n = 26), lidocaine 1% group (0.5 mg/kg, n = 25), and normal saline group (n = 25). Drug doses were prepared in normal saline to a total volume of 5 ml. Venous occlusion was applied 10 cm above the venous access site. Pretreatment drugs were injected and retained for 60 s at the site of injection by an anesthetist blinded to group allocation. After release of the tourniquet, rocuronium (0.5 mg/kg) was then injected over 5 s, and withdrawal was recorded by another anesthetist blinded to group allocation. Descriptive statistics, analysis of variance, and a chi-squared test were used to statistically analyze the results as appropriate. Compared to normal saline, all other pretreatment groups scored a significantly lower mean of withdrawal response (P < 0.001). Lidocaine was superior to both remifentanil (P < 0.05) and fentanyl (P < 0.05) in suppressing the withdrawal response to rocuronium injection. Remifentanil was superior to fentanyl in suppressing the withdrawal response caused by rocuronium injection (P < 0.001). Using a venous occlusion technique for 60 s, lidocaine was found to be most effective in preventing the withdrawal effect caused by rocuronium injection in children and adolescents. Lidocaine was superior to remifentanil which, in turn, was more effective than fentanyl.

Quality of life and psychosocial and physical well-being among 1,023 women during their first assisted reproductive technology treatment: secondary outcome to a randomized controlled trial comparing gonadotropin-releasing hormone (GnRH) antagonist and GnRH agonist protocols.

PubMed

Toftager, Mette; Sylvest, Randi; Schmidt, Lone; Bogstad, Jeanette; Løssl, Kristine; Prætorius, Lisbeth; Zedeler, Anne; Bryndorf, Thue; Pinborg, Anja

2018-01-01

To compare self-reported quality of life, psychosocial well-being, and physical well-being during assisted reproductive technology (ART) treatment in 1,023 women allocated to either a short GnRH antagonist or long GnRH agonist protocol. Secondary outcome of a prospective phase 4, open-label, randomized controlled trial. Four times during treatment a questionnaire on self-reported physical well-being was completed. Further, a questionnaire on self-reported quality of life and psychosocial well-being was completed at the day of hCG testing. Fertility clinics at university hospitals. Women referred for their first ART treatment were randomized in a 1:1 ratio and started standardized ART protocols. Gonadotropin-releasing hormone analogue; 528 women allocated to a short GnRH antagonist protocol and 495 women allocated to a long GnRH agonist protocol. Self-reported quality of life, psychosocial well-being, and physical well-being based on questionnaires developed for women receiving ART treatment. Baseline characteristics were similar, and response rates were 79.4% and 74.3% in the GnRH antagonist and GnRH agonist groups, respectively. Self-reported quality of life during ART treatment was rated similar and slightly below normal in both groups. However, women in the GnRH antagonist group felt less emotional (adjusted odds ratio [AOR] 0.69), less limited in their everyday life (AOR 0.74), experienced less unexpected crying (AOR 0.71), and rated quality of sleep better (AOR 1.55). Further, women receiving GnRH agonist treatment felt worse physically. Women in a short GnRH antagonist protocol rated psychosocial and physical well-being during first ART treatment better than did women in a long GnRH agonist protocol. However, the one item on self-reported general quality of life was rated similarly. NCT00756028. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Effect of adding postoperative noninvasive ventilation to usual care to prevent pulmonary complications in patients undergoing coronary artery bypass grafting: a randomized controlled trial.

PubMed

Al Jaaly, Emad; Fiorentino, Francesca; Reeves, Barnaby C; Ind, Philip W; Angelini, Gianni D; Kemp, Scott; Shiner, Robert J

2013-10-01

We compared the efficacy of noninvasive ventilation with bilevel positive airway pressure added to usual care versus usual care alone in patients undergoing coronary artery bypass grafting. We performed a 2-group, parallel, randomized controlled trial. The primary outcome was time until fit for discharge. Secondary outcomes were partial pressure of carbon dioxide, forced expiratory volume in 1 second, atelectasis, adverse events, duration of intensive care stay, and actual postoperative stay. A total of 129 patients were randomly allocated to bilevel positive airway pressure (66) or usual care (63). Three patients allocated to bilevel positive airway pressure withdrew. The median duration of bilevel positive airway pressure was 16 hours (interquartile range, 11-19). The median duration of hospital stay until fit for discharge was 5 days for the bilevel positive airway pressure group (interquartile range, 4-6) and 6 days for the usual care group (interquartile range, 5-7; hazard ratio, 1.68; 95% confidence interval, 1.08-2.31; P = .019). There was no significant difference in duration of intensive care, actual postoperative stay, and mean percentage of predicted forced expiratory volume in 1 second on day 3. Mean partial pressure of carbon dioxide was significantly reduced 1 hour after bilevel positive airway pressure application, but there was no overall difference between the groups up to 24 hours. Basal atelectasis occurred in 15 patients (24%) in the usual care group and 2 patients (3%) in the bilevel positive airway pressure group. Overall, 30% of patients in the bilevel positive airway pressure group experienced an adverse event compared with 59% in the usual care group. Among patients undergoing elective coronary artery bypass grafting, the use of bilevel positive airway pressure at extubation reduced the recovery time. Supported by trained staff, more than 75% of all patients allocated to bilevel positive airway pressure tolerated it for more than 10 hours. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Appropriate prescribing in nursing homes demonstration project (APDP) study protocol: pragmatic, cluster-randomized trial and mixed methods process evaluation of an Ontario policy-maker initiative to improve appropriate prescribing of antipsychotics.

PubMed

Desveaux, Laura; Gomes, Tara; Tadrous, Mina; Jeffs, Lianne; Taljaard, Monica; Rogers, Jess; Bell, Chaim M; Ivers, Noah M

2016-03-29

Antipsychotic medications are routinely prescribed in nursing homes to address the behavioral and psychological symptoms of dementia. Unfortunately, inappropriate prescribing of antipsychotic medications is common and associated with increased morbidity, adverse drug events, and hospitalizations. Multifaceted interventions can achieve a 12-20 % reduction in antipsychotic prescribing levels in nursing homes. Effective interventions have featured educational outreach and ongoing performance feedback. This pragmatic, cluster-randomized control trial and embedded process evaluation seeks to determine the effect of adding academic detailing to audit and feedback on prescribing of antipsychotic medications in nursing homes, compared with audit and feedback alone. Nursing homes within pre-determined regions of Ontario, Canada, are eligible if they express an interest in the intervention. The academic detailing intervention will be delivered by registered health professionals following an intensive training program including relevant clinical issues and techniques to support health professional behavior change. Physicians in both groups will have the opportunity to access confidential reports summarizing their prescribing patterns for antipsychotics in comparison to the local and provincial average. Participating homes will be allocated to one of the two arms of the study (active/full intervention versus standard audit and feedback) in two waves, with a 2:1 allocation ratio. Homes will be randomized after stratifying for geography, baseline antipsychotic prescription rates, and size, to ensure a balance of characteristics. The primary outcome is antipsychotic dispensing in nursing homes, measured 6 months after allocation; secondary outcomes include clinical outcomes and healthcare utilization. Policy-makers and the public have taken note that antipsychotics are used in nursing homes in Ontario far more than other jurisdictions. Academic detailing can be an effective technique to address challenges in appropriate prescribing in nursing homes, but effect sizes vary widely. This opportunistic, policy-driven evaluation, embedded within a government-initiated demonstration project, was designed to ensure policy-makers receive the best evidence possible regarding whether and how to scale up the intervention. ClinicalTrials.gov NLM Identifier: NCT02604056 .

Worldwide trends in volume and quality of published protocols of randomized controlled trials

PubMed Central

Alldinger, Ingo; Cieslak, Kasia P.; Wennink, Roos; Clarke, Mike; Ali, Usama Ahmed; Besselink, Marc G. H.

2017-01-01

Introduction Publishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols. Methods A systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty. Results The number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40–0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09–3.45, p = 0.02). Conclusion Publishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between geographical regions and across medical specialties was seen. This emphasizes the importance of international standards of comprehensive training in RCT methodology. PMID:28296925

Sexual intercourse for cervical ripening and induction of labour.

PubMed

Kavanagh, J; Kelly, A J; Thomas, J

2001-01-01

The role of prostaglandins for cervical ripening and induction of labour has been examined extensively. Human semen is the biological source that is presumed to contain the highest prostaglandin concentration. The role of sexual intercourse in the initiation of labour is uncertain. The action of sexual intercourse in stimulating labour is unclear, it may in part be due to the physical stimulation of the lower uterine segment, or endogenous release of oxytocin as a result of orgasm or from the direct action of prostaglandins in semen. Furthermore nipple stimulation may be part of the process of initiation. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. To determine the effects of sexual intercourse for third trimester cervical ripening or induction of labour in comparison with other methods of induction. The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: November 2000. (1) clinical trials comparing sexual intercourse for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusion. A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. There was one included study of 28 women which reported very limited data, from which no meaningful conclusions can be drawn. The role of sexual intercourse as a method of induction of labour is uncertain. Any future trials investigating sexual intercourse as a method of induction need to be of sufficient power to detect clinically relevant differences in standard outcomes. However, it may prove difficult to standardise sexual intercourse as an intervention to allow meaningful comparisons with other methods of induction of labour.

Randomization Does Not Help Much, Comparability Does

PubMed Central

Saint-Mont, Uwe

2015-01-01

According to R.A. Fisher, randomization “relieves the experimenter from the anxiety of considering innumerable causes by which the data may be disturbed.” Since, in particular, it is said to control for known and unknown nuisance factors that may considerably challenge the validity of a result, it has become very popular. This contribution challenges the received view. First, looking for quantitative support, we study a number of straightforward, mathematically simple models. They all demonstrate that the optimism surrounding randomization is questionable: In small to medium-sized samples, random allocation of units to treatments typically yields a considerable imbalance between the groups, i.e., confounding due to randomization is the rule rather than the exception. In the second part of this contribution, the reasoning is extended to a number of traditional arguments in favour of randomization. This discussion is rather non-technical, and sometimes touches on the rather fundamental Frequentist/Bayesian debate. However, the result of this analysis turns out to be quite similar: While the contribution of randomization remains doubtful, comparability contributes much to a compelling conclusion. Summing up, classical experimentation based on sound background theory and the systematic construction of exchangeable groups seems to be advisable. PMID:26193621

Doxycycline for outpatient-treated acute exacerbations of COPD: a randomised double-blind placebo-controlled trial.

PubMed

van Velzen, Patricia; Ter Riet, Gerben; Bresser, Paul; Baars, Jeroen J; van den Berg, Bob T J; van den Berg, Jan W K; Brinkman, Paul; Dagelet, Jennece W F; Daniels, Johannes M A; Groeneveld-Tjiong, Dewi R G L; Jonkers, René E; van Kan, Coen; Krouwels, Frans H; Pool, Karin; Rudolphus, Arjan; Sterk, Peter J; Prins, Jan M

2017-06-01

Antibiotics do not reduce mortality or short-term treatment non-response in patients receiving treatment for acute exacerbations of COPD in an outpatient setting. However, the long-term effects of antibiotics are unknown. The aim of this study was to investigate if the antibiotic doxycycline added to the oral corticosteroid prednisolone prolongs time to next exacerbation in patients with COPD receiving treatment for an exacerbation in the outpatient setting. In this randomised double-blind placebo-controlled trial, we recruited a cohort of patients with COPD from outpatient clinics of nine teaching hospitals and three primary care centres in the Netherlands. Inclusion criteria were an age of at least 45 years, a smoking history of at least 10 pack-years, mild-to-severe COPD (Global Initiative of Chronic Obstructive Lung Disease [GOLD] stage 1-3), and at least one exacerbation during the past 3 years. Exclusion criteria were poor mastery of the Dutch language, poor cognitive functioning, known allergy to doxycycline, pregnancy, and a life expectancy of shorter than 1 month. If a participant had an exacerbation, we randomly assigned them (1:1; with permuted blocks of variable sizes [ranging from two to ten]; stratified by GOLD stage 1-2 vs 3) to a 7 day course of oral doxycycline 100 mg daily (200 mg on the first day) or placebo. Exclusion criteria for randomisation were fever, admission to hospital, and current use of antibiotics or use within the previous 3 weeks. Patients in both groups received a 10 day course of 30 mg oral prednisolone daily. Patients, investigators, and those assessing outcomes were masked to treatment assignment. The primary outcome was time to next exacerbation in all randomly allocated patients except for those incorrectly randomly allocated who did not meet the inclusion criteria or met the exclusion criteria. This trial is registered with the Netherlands Trial Register, number NTR2499. Between Dec 22, 2010, and Aug 6, 2013, we randomly allocated 305 (34%) patients from the cohort of 887 patients to doxycycline (152 [50%]) or placebo (153 [50%]), excluding four (1%) patients (two [1%] from each group) who were incorrectly randomly allocated from the analysis. 257 (85%) of 301 patients had a next exacerbation (131 [87%] of 150 in the doxycycline group vs 126 [83%] of 151 in the placebo group). Median time to next exacerbation was 148 days (95% CI 95-200) in the doxycycline group compared with 161 days (118-211) in the placebo group (hazard ratio 1·01 [95% CI 0·79-1·31]; p=0·91). We did not note any significant differences between groups in the frequency of adverse events during the first 2 weeks after randomisation (47 [31%] of 150 in the doxycycline group vs 53 [35%] of 151 in the placebo group; p=0·54) or in serious adverse events during the 2 years of follow-up (42 [28%] vs 43 [29%]; p=1). In patients with mild-to-severe COPD receiving treatment for an exacerbation in an outpatient setting, the antibiotic doxycycline added to the oral corticosteroid prednisolone did not prolong time to next exacerbation compared with prednisolone alone. These findings do not support prescription of antibiotics for COPD exacerbations in an outpatient setting. Netherlands Organization for Health Research and Development. Copyright © 2017 Elsevier Ltd. All rights reserved.

Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial

PubMed Central

HASSAN, S. S.; ROMERO, R.; VIDYADHARI, D.; FUSEY, S.; BAXTER, J. K.; KHANDELWAL, M.; VIJAYARAGHAVAN, J.; TRIVEDI, Y.; SOMA-PILLAY, P.; SAMBAREY, P.; DAYAL, A.; POTAPOV, V.; O’BRIEN, J.; ASTAKHOV, V.; YUZKO, O.; KINZLER, W.; DATTEL, B.; SEHDEV, H.; MAZHEIKA, L.; MANCHULENKO, D.; GERVASI, M. T.; SULLIVAN, L.; CONDE-AGUDELO, A.; PHILLIPS, J. A.; CREASY, G. W.

2012-01-01

Objectives Women with a sonographic short cervix in the mid-trimester are at increased risk for preterm delivery. This study was undertaken to determine the ef cacy and safety of using micronized vaginal progesterone gel to reduce the risk of preterm birth and associated neonatal complications in women with a sonographic short cervix. Methods This was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled asymptomatic women with a singleton pregnancy and a sonographic short cervix (10–20 mm) at 19 + 0to23 + 6 weeks of gestation. Women were allocated randomly to receive vaginal progesterone gel or placebo daily starting from 20 to 23 + 6 weeks until 36 + 6 weeks, rupture of membranes or delivery, whichever occurred rst. Randomization sequence was strati ed by center and history of a previous preterm birth. The primary endpoint was preterm birth before 33 weeks of gestation. Analysis was by intention to treat. Results Of 465 women randomized, seven were lost to follow-up and 458 (vaginal progesterone gel, n = 235; placebo, n = 223) were included in the analysis. Women allocated to receive vaginal progesterone had a lower rate of preterm birth before 33 weeks than did those allocated to placebo (8.9% (n = 21) vs 16.1% (n = 36); relative risk (RR), 0.55; 95% CI, 0.33–0.92; P = 0.02). The effect remained signi cant after adjustment for covariables (adjusted RR, 0.52; 95% CI, 0.31–0.91; P = 0.02). Vaginal progesterone was also associated with a signi cant reduction in the rate of preterm birth before 28 weeks(5.1%vs10.3%; RR, 0.50;95%CI, 0.25–0.97; P = 0.04) and 35 weeks (14.5% vs 23.3%; RR, 0.62; 95% CI, 0.42–0.92; P = 0.02), respiratory distress syndrome (3.0% vs 7.6%; RR, 0.39; 95% CI, 0.17–0.92; P = 0.03), any neonatal morbidity or mortality event (7.7% vs 13.5%; RR, 0.57; 95% CI, 0.33–0.99; P = 0.04) and birth weight < 1500 g (6.4% (15/234) vs 13.6% (30/220); RR, 0.47; 95% CI, 0.26–0.85; P = 0.01). There were no differences in the incidence of treatment-related adverse events between the groups. Conclusions The administration of vaginal progesterone gel to women with a sonographic short cervix in the mid-trimester is associated with a 45% reduction in the rate of preterm birth before 33 weeks of gestation and with improved neonatal outcome. PMID:21472815

Semmelweis's methodology from the modern stand-point: intervention studies and causal ontology.

PubMed

Persson, Johannes

2009-09-01

Semmelweis's work predates the discovery of the power of randomization in medicine by almost a century. Although Semmelweis would not have consciously used a randomized controlled trial (RCT), some features of his material-the allocation of patients to the first and second clinics-did involve what was in fact a randomization, though this was not realised at the time. This article begins by explaining why Semmelweis's methodology, nevertheless, did not amount to the use of a RCT. It then shows why it is descriptively and normatively interesting to compare what he did with the modern approach using RCTs. The argumentation centres on causal inferences and the contrast between Semmelweis's causal concept and that deployed by many advocates of RCTs. It is argued that Semmelweis's approach has implications for matters of explanation and medical practice.

Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT): a multicentre, open-label randomised controlled trial.

PubMed

Koopmans, Corine M; Bijlenga, Denise; Groen, Henk; Vijgen, Sylvia M C; Aarnoudse, Jan G; Bekedam, Dick J; van den Berg, Paul P; de Boer, Karin; Burggraaff, Jan M; Bloemenkamp, Kitty W M; Drogtrop, Addy P; Franx, Arie; de Groot, Christianne J M; Huisjes, Anjoke J M; Kwee, Anneke; van Loon, Aren J; Lub, Annemiek; Papatsonis, Dimitri N M; van der Post, Joris A M; Roumen, Frans J M E; Scheepers, Hubertina C J; Willekes, Christine; Mol, Ben W J; van Pampus, Maria G

2009-09-19

Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36-41 weeks' gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome--maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 mL blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825. 756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0.71, 95% CI 0.59-0.86, p<0.0001). No cases of maternal or neonatal death or eclampsia were recorded. Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation. ZonMw.

Empirical Analysis of EEG and ERPs for Psychophysiological Adaptive Task Allocation

NASA Technical Reports Server (NTRS)

Prinzel, Lawrence J., III; Pope, Alan T.; Freeman, Frederick G.; Scerbo, Mark W.; Mikulka, Peter J.

2001-01-01

The present study was designed to test the efficacy of using Electroencephalogram (EEG) and Event-Related Potentials (ERPs) for making task allocation decisions. Thirty-six participants were randomly assigned to an experimental, yoked, or control group condition. Under the experimental condition, a tracking task was switched between task modes based upon the participant's EEG. The results showed that the use of adaptive aiding improved performance and lowered subjective workload under negative feedback as predicted. Additionally, participants in the adaptive group had significantly lower RMSE and NASA-TLX ratings than participants in either the yoked or control group conditions. Furthermore, the amplitudes of the N1 and P3 ERP components were significantly larger under the experimental group condition than under either the yoked or control group conditions. These results are discussed in terms of the implications for adaptive automation design.

The Program and Treatment Effect of Summer Jobs on Girls' Post-Schooling Incomes.

PubMed

Alam, Moudud; Carling, Kenneth; Nääs, Ola

2015-06-01

Public programs offering summer jobs to smooth the transition from school to work is commonplace. However, the empirical support for summer jobs is limited. This article exploits the availability of registered individual information and random allocation to summer jobs to provide empirical evidence on this issue. To identify the effect of summer job programs on the post-schooling incomes of the intended participants. Also to identify the effect of sophomore girls' high school work experience on their post-schooling incomes. In this article, 1,447 sophomore girls from 1997 to 2003 are followed 5-12 years after graduation. They all applied to Falun municipality's (Sweden) summer job program, and about 25% of them were randomly allotted a job. The random allocation to a summer job is used to identify the causal effect of sophomore girls' high school income on their post-schooling incomes. All the 1,447 sophomore girls who applied to Falun municipality's summer job program during 1997-2003. Annual post-schooling income is used as an outcome measure. The work experience of girls in high school is also measured in terms of total income while in high school. The program led to a substantially larger accumulation of income during high school as well as 19% higher post-schooling incomes. The high school income led to a post-schooling income elasticity of 0.37 which is, however, potentially heterogeneous with regard to academic ability. Both the program effect and the causal effect of high school income on post-schooling incomes were substantial and statistically significant. © The Author(s) 2015.

A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol.

PubMed

Garrison, Kathleen A; Pal, Prasanta; Rojiani, Rahil; Dallery, Jesse; O'Malley, Stephanie S; Brewer, Judson A

2015-04-14

Tobacco use is responsible for the death of about 1 in 10 individuals worldwide. Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation. Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training. This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up. A two-group parallel-randomized clinical trial with allocation concealment will be conducted. Group assignment will be concealed from study researchers through to follow-up. The study will be conducted by smartphone and online. Daily smokers who are interested in quitting smoking and own a smartphone (n = 140) will be recruited through study advertisements posted online. After completion of a baseline survey, participants will be allocated randomly to the control or intervention group. Participants in both groups will receive a 22-day smartphone-based treatment program for smoking. Participants in the intervention group will receive mobile mindfulness training plus experience sampling. Participants in the control group will receive experience sampling-only. The primary outcome measure will be one-week point prevalence abstinence from smoking (at 6-months follow-up) assessed using carbon monoxide breath monitoring, which will be validated through smartphone-based video chat. This is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation. Such an intervention may provide treatment in-hand, in real-world contexts, to help individuals quit smoking. Clinicaltrials.gov NCT02134509 . Registered 7 May 2014.

Long-chain omega-3 fatty acids in aneurysmal subarachnoid hemorrhage: A randomized pilot trial of pharmaconutrition.

PubMed

Saito, Geisi; Zapata, Rodrigo; Rivera, Rodrigo; Zambrano, Héctor; Rojas, David; Acevedo, Hernán; Ravera, Franco; Mosquera, John; Vásquez, Juan E; Mura, Jorge

2017-01-01

Functional recovery after aneurysmal subarachnoid hemorrhage (SAH) remains a significant problem. We tested a novel therapeutic approach with long-chain omega-3 polyunsaturated fatty acids (n-3 PUFAs) to assess the safety and feasibility of an effectiveness trial. We conducted a multicentre, parallel, randomized, open-label pilot trial. Patients admitted within 72 hours after SAH with modified Fisher scale scores of 3 or 4 who were selected for scheduled aneurysm clipping were allocated to receive either n-3 PUFA treatment (parenteral perioperative: 5 days; oral: 8 weeks) plus usual care or usual care alone. Exploratory outcome measures included major postoperative intracranial bleeding complications (PIBCs), cerebral infarction caused by delayed cerebral ischemia, shunt-dependent hydrocephalus, and consent rate. The computed tomography evaluator was blinded to the group assignment. Forty-one patients were randomized, but one patient had to be excluded after allocation. Twenty patients remained for intention to treat analysis in each trial arm. No PIBs (95% confidence interval [CI]: 0.00 to 0.16) or other unexpected harm were observed in the intervention group (IG). No patient suspended the intervention due to side effects. There was a trend towards improvements in all benefit-related outcomes in the IG. The overall consent rate was 0.91 (95% CI: 0.78 to 0.96), and there was no consent withdrawal. Although the balance between the benefit and harm of the intervention appears highly favourable, further testing on SAH patients is required. We recommend proceeding with amendments in a dose-finding trial to determine the optimal duration of parenteral treatment.

Cost-effectiveness of a primary care treatment program for depression in low-income women in Santiago, Chile.

PubMed

Araya, Ricardo; Flynn, Terry; Rojas, Graciela; Fritsch, Rosemarie; Simon, Greg

2006-08-01

The authors compared the incremental cost-effectiveness of a stepped-care, multicomponent program with usual care for the treatment of depressed women in primary care in Santiago, Chile. A cost-effectiveness study was conducted of a previous randomized controlled trial involving 240 eligible women with DSM-IV major depression who were selected from a consecutive sample of adult women attending primary care clinics. The patients were randomly allocated to usual care or a multicomponent stepped-care program led by a nonmedical health care worker. Depression-free days and health care costs derived from local sources were assessed after 3 and 6 months. A health service perspective was used in the economic analysis. Complete data were determined for 80% of the randomly assigned patients. After we adjusted for initial severity, women receiving the stepped-care program had a mean of 50 additional depression-free days over 6 months relative to patients allocated to usual care. The stepped-care program was marginally more expensive than usual care (an extra 216 Chilean pesos per depression-free day). There was a 90% probability that the incremental cost of obtaining an extra depression-free day with the intervention would not exceed 300 pesos (1.04 US dollars). The stepped-care program was significantly more effective and marginally more expensive than usual care for the treatment of depressed women in primary care. Small investments to improve depression appear to yield larger gains in poorer environments. Simple and inexpensive treatment programs tested in developing countries might provide good study models for developed countries.

Does Computerized Cognitive Behavioral Therapy Help People with Inflammatory Bowel Disease? A Randomized Controlled Trial.

PubMed

McCombie, Andrew; Gearry, Richard; Andrews, Jane; Mulder, Roger; Mikocka-Walus, Antonina

2016-01-01

Cognitive behavioral therapy may be useful for improving health-related quality of life (HRQOL) of at least some patients with inflammatory bowel disease (IBD), especially those with psychiatric comorbidities. However, cognitive behavioral therapy can be difficult to access. These difficulties can be overcome by computerized cognitive behavioral therapy (CCBT). This is a randomized controlled trial of a self-administered CCBT intervention for patients with IBD focused on improving HRQOL. It is hypothesized that CCBT completers will have an improved HRQOL relative to people not allocated to CCBT. Patients with IBD were randomly allocated to CCBT (n = 113) versus treatment as usual (n = 86). The IBD Questionnaire at 12 weeks after baseline was the primary outcome, while generic HRQOL, anxiety, depression, coping strategies, perceived stress, and IBD symptoms were secondary outcomes. Outcomes were also measured at 6 months after baseline. Predictors of dropout were also determined. Twenty-nine CCBT participants (25.7%) completed the CCBT. The IBD Questionnaire was significantly increased at 12 weeks in CCBT completers compared with treatment-as-usual patients (F = 6.38, P = 0.01). Short Form-12 mental score (F = 5.00, P = 0.03) was also significantly better in CCBT compared with treatment-as-usual patients at 12 weeks. These outcomes were not maintained at 6 months. The predictors of dropout were baseline depression, biological use, lower IBD Questionnaire scores, and not having steroids. Improvements at 12 weeks after baseline were not maintained at 6 months. Future research should aim to improve adherence rates. Moreover, CCBT may not work for patients with IBD with comorbid depression.

Does the bracket–ligature combination affect the amount of orthodontic space closure over three months? A randomized controlled trial

PubMed Central

Wong, Henry; Collins, Jill; Tinsley, David; Sandler, Jonathan; Benson, Philip

2013-01-01

Objective: To investigate the effect of bracket–ligature combination on the amount of orthodontic space closure over three months. Design: Randomized clinical trial with three parallel groups. Setting: A hospital orthodontic department (Chesterfield Royal Hospital, UK). Participants: Forty-five patients requiring upper first premolar extractions. Methods: Informed consent was obtained and participants were randomly allocated into one of three groups: (1) conventional pre-adjusted edgewise brackets and elastomeric ligatures; (2) conventional pre-adjusted edgewise brackets and Super Slick® low friction elastomeric ligatures; (3) Damon 3MX® passive self-ligating brackets. Space closure was undertaken on 0·019×0·025-inch stainless steel archwires with nickel–titanium coil springs. Participants were recalled at four weekly intervals. Upper alginate impressions were taken at each visit (maximum three). The primary outcome measure was the mean amount of space closure in a 3-month period. Results: A one-way ANOVA was undertaken [dependent variable: mean space closure (mm); independent variable: group allocation]. The amount of space closure was very similar between the three groups (1 mm per 28 days); however, there was a wide variation in the rate of space closure between individuals. The differences in the amount of space closure over three months between the three groups was very small and non-significant (P = 0·718). Conclusion: The hypothesis that reducing friction by modifying the bracket/ligature interface increases the rate of space closure was not supported. The major determinant of orthodontic tooth movement is probably the individual patient response. PMID:23794696

Promoting Peer Acceptance of Females with Higher-Functioning Autism in a Mainstream Education Setting: A Replication and Extension of the Effects of an Autism Anti-Stigma Program

ERIC Educational Resources Information Center

Ranson, Natalia J.; Byrne, Mitchell K.

2014-01-01

This study evaluated the effects of an eight-session female higher-functioning autism anti-stigma program on the knowledge, attitudes and behavioural intentions of adolescent girls. Participants were seventh-, eighth- and ninth-grade students (N = 273) in a mainstream school. Two-eighth-grade classes were randomly allocated to the intervention…

Effects of a Special Olympics Unified Sports Soccer Program on Psycho-Social Attributes of Youth with and without Intellectual Disability

ERIC Educational Resources Information Center

Ozer, D.; Baran, F.; Aktop, A.; Nalbant, S.; Aglamis, E.; Hutzler, Y.

2012-01-01

The purpose of the study was to investigate the effects of a Special Olympics (SO) Unified Sports (UNS) soccer program on psycho-social attributes of youth with and without intellectual disabilities (ID). Participants were 76 male youth with (n = 38) and without (n = 38) ID. Participants with ID were randomly allocated into a SO athletes group (n…

Effects of transcutaneous electrical nerve stimulation on pain, walking function, respiratory muscle strength and vital capacity in kidney donors: a protocol of a randomized controlled trial

PubMed Central

2013-01-01

Background Pain is a negative factor in the recovery process of postoperative patients, causing pulmonary alterations and complications and affecting functional capacity. Thus, it is plausible to introduce transcutaneous electrical nerve stimulation (TENS) for pain relief to subsequently reduce complications caused by this pain in the postoperative period. The objective of this paper is to assess the effects of TENS on pain, walking function, respiratory muscle strength and vital capacity in kidney donors. Methods/design Seventy-four patients will be randomly allocated into 2 groups: active TENS or placebo TENS. All patients will be assessed for pain intensity, walk function (Iowa Gait Test), respiratory muscle strength (maximal inspiratory pressure and maximal expiratory pressure) and vital capacity before and after the TENS application. The data will be collected by an assessor who is blinded to the group allocation. Discussion This study is the first to examine the effects of TENS in this population. TENS during the postoperative period may result in pain relief and improvements in pulmonary tests and mobility, thus leading to an improved quality of life and further promoting organ donation. Trial registration Registro Brasileiro de Ensaios Clinicos (ReBEC), number RBR-8xtkjp. PMID:23311705

Random Forest Segregation of Drug Responses May Define Regions of Biological Significance

PubMed Central

Bukhari, Qasim; Borsook, David; Rudin, Markus; Becerra, Lino

2016-01-01

The ability to assess brain responses in unsupervised manner based on fMRI measure has remained a challenge. Here we have applied the Random Forest (RF) method to detect differences in the pharmacological MRI (phMRI) response in rats to treatment with an analgesic drug (buprenorphine) as compared to control (saline). Three groups of animals were studied: two groups treated with different doses of the opioid buprenorphine, low (LD), and high dose (HD), and one receiving saline. PhMRI responses were evaluated in 45 brain regions and RF analysis was applied to allocate rats to the individual treatment groups. RF analysis was able to identify drug effects based on differential phMRI responses in the hippocampus, amygdala, nucleus accumbens, superior colliculus, and the lateral and posterior thalamus for drug vs. saline. These structures have high levels of mu opioid receptors. In addition these regions are involved in aversive signaling, which is inhibited by mu opioids. The results demonstrate that buprenorphine mediated phMRI responses comprise characteristic features that allow a supervised differentiation from placebo treated rats as well as the proper allocation to the respective drug dose group using the RF method, a method that has been successfully applied in clinical studies. PMID:27014046

Predicting losing and gaining river reaches in lowland New Zealand based on a statistical methodology

NASA Astrophysics Data System (ADS)

Yang, Jing; Zammit, Christian; Dudley, Bruce

2017-04-01

The phenomenon of losing and gaining in rivers normally takes place in lowland where often there are various, sometimes conflicting uses for water resources, e.g., agriculture, industry, recreation, and maintenance of ecosystem function. To better support water allocation decisions, it is crucial to understand the location and seasonal dynamics of these losses and gains. We present a statistical methodology to predict losing and gaining river reaches in New Zealand based on 1) information surveys with surface water and groundwater experts from regional government, 2) A collection of river/watershed characteristics, including climate, soil and hydrogeologic information, and 3) the random forests technique. The surveys on losing and gaining reaches were conducted face-to-face at 16 New Zealand regional government authorities, and climate, soil, river geometry, and hydrogeologic data from various sources were collected and compiled to represent river/watershed characteristics. The random forests technique was used to build up the statistical relationship between river reach status (gain and loss) and river/watershed characteristics, and then to predict for river reaches at Strahler order one without prior losing and gaining information. Results show that the model has a classification error of around 10% for "gain" and "loss". The results will assist further research, and water allocation decisions in lowland New Zealand.

Managing military training-related environmental disturbance.

PubMed

Zentelis, Rick; Banks, Sam; Roberts, J Dale; Dovers, Stephen; Lindenmayer, David

2017-12-15

Military Training Areas (MTAs) cover at least 2 percent of the Earth's terrestrial surface and occur in all major biomes. These areas are potentially important for biodiversity conservation. The greatest challenge in managing MTAs is balancing the disturbance associated with military training and environmental values. These challenges are unique as no other land use is managed for these types of anthropogenic disturbances in a natural setting. We investigated how military training-related disturbance is best managed on MTAs. Specifically, we explored management options to maximise the amount of military training that can be undertaken on a MTA while minimising the amount of environmental disturbance. MTAs comprise of a number of ranges designed to facilitate different types of military training. We simulated military training-related environmental disturbance at different range usage rates under a typical range rotation use strategy, and compared the results to estimated ecosystem recovery rates from training activities. We found that even at relatively low simulated usage rates, random allocation and random spatial use of training ranges within an MTA resulted in environmental degradation under realistic ecological recovery rates. To avoid large scale environmental degradation, we developed a decision-making tool that details the best method for managing training-related disturbance by determining how training activities can be allocated to training ranges. Copyright © 2017 Elsevier Ltd. All rights reserved.

Strategic allocation of attention reduces temporally predictable stimulus conflict

PubMed Central

Appelbaum, L. Gregory; Boehler, Carsten N.; Won, Robert; Davis, Lauren; Woldorff, Marty G.

2013-01-01

Humans are able to continuously monitor environmental situations and adjust their behavioral strategies to optimize performance. Here we investigate the behavioral and brain adjustments that occur when conflicting stimulus elements are, or are not, temporally predictable. Event-related potentials (ERPs) were collected while manual-response variants of the Stroop task were performed in which the stimulus onset asynchronies (SOAs) between the relevant-color and irrelevant-word stimulus components were either randomly intermixed, or held constant, within each experimental run. Results indicated that the size of both the neural and behavioral effects of stimulus incongruency varied with the temporal arrangement of the stimulus components, such that the random-SOA arrangements produced the greatest incongruency effects at the earliest irrelevant-first SOA (−200 ms) and the constant-SOA arrangements produced the greatest effects with simultaneous presentation. These differences in conflict processing were accompanied by rapid (~150 ms) modulations of the sensory ERPs to the irrelevant distracter components when they occurred consistently first. These effects suggest that individuals are able to strategically allocate attention in time to mitigate the influence of a temporally predictable distracter. As these adjustments are instantiated by the subjects without instruction, they reveal a form of rapid strategic learning for dealing with temporally predictable stimulus incongruency. PMID:22360623

Randomization in cancer clinical trials: permutation test and development of a computer program.

PubMed Central

Ohashi, Y

1990-01-01

When analyzing cancer clinical trial data where the treatment allocation is done using dynamic balancing methods such as the minimization method for balancing the distribution of important prognostic factors in each arm, conservativeness occurs if such a randomization scheme is ignored and a simple unstratified analysis is carried out. In this paper, the above conservativeness is demonstrated by computer simulation, and the development of a computer program that carries out permutation tests of the log-rank statistics for clinical trial data where the allocation is done by the minimization method or a stratified permuted block design is introduced. We are planning to use this program in practice to supplement a usual stratified analysis and model-based methods such as the Cox regression. The most serious problem in cancer clinical trials in Japan is how to carry out the quality control or data management in trials that are initiated and conducted by researchers without support from pharmaceutical companies. In the final section of this paper, one international collaborative work for developing international guidelines on data management in clinical trials of bladder cancer is briefly introduced, and the differences between the system adopted in US/European statistical centers and the Japanese system is described. PMID:2269216

A Web-Based Telehealth Training Platform Incorporating Automated Nonverbal Behavior Feedback for Teaching Communication Skills to Medical Students: A Randomized Crossover Study

PubMed Central

2016-01-01

Background In the interests of patient health outcomes, it is important for medical students to develop clinical communication skills. We previously proposed a telehealth communication skills training platform (EQClinic) with automated nonverbal behavior feedback for medical students, and it was able to improve medical students’ awareness of their nonverbal communication. Objective This study aimed to evaluate the effectiveness of EQClinic to improve clinical communication skills of medical students. Methods We conducted a 2-group randomized crossover trial between February and June 2016. Participants were second-year medical students enrolled in a clinical communication skills course at an Australian university. Students were randomly allocated to complete online EQClinic training during weeks 1–5 (group A) or to complete EQClinic training during weeks 8–11 (group B). EQClinic delivered an automated visual presentation of students’ nonverbal behavior coupled with human feedback from a standardized patient (SP). All students were offered two opportunities to complete face-to-face consultations with SPs. The two face-to-face consultations were conducted in weeks 6–7 and 12–13 for both groups, and were rated by tutors who were blinded to group allocation. Student-Patient Observed Communication Assessment (SOCA) was collected by blinded assessors (n=28) at 2 time points and also by an SP (n=83). Tutor-rated clinical communications skill in face-to-face consultations was the primary outcome and was assessed with the SOCA. We used t tests to examine the students’ performance during face-to-face consultations pre- and postexposure to EQClinic. Results We randomly allocated 268 medical students to the 2 groups (group A: n=133; group B: n=135). SOCA communication skills measures (score range 4–16) from the first face-to-face consultation were significantly higher for students in group A who had completed EQClinic training and reviewed the nonverbal behavior feedback, compared with group B, who had completed only the course curriculum components (P=.04). Furthermore, at the second face-to-face assessment, the group that completed a teleconsultation between the two face-to-face consultations (group B) showed improved communication skills (P=.005), and the one that had teleconsultations before the first face-to-face consultation (group A) did not show improvement. Conclusions The EQClinic is a useful tool for medical students’ clinical communication skills training that can be applied to university settings to improve students clinical communication skills development. PMID:27619564

Minimum intervention dentistry approach to managing early childhood caries: a randomized control trial.

PubMed

Arrow, Peter; Klobas, Elizabeth

2015-12-01

A pragmatic randomized control trial was undertaken to compare the minimum intervention dentistry (MID) approach, based on the atraumatic restorative treatment procedures (MID-ART: Test), against the standard care approach (Control) to treat early childhood caries in a primary care setting. Consenting parent/child dyads were allocated to the Test or Control group using stratified block randomization. Inclusion and exclusion criteria were applied. Participants were examined at baseline and at follow-up by two calibrated examiners blind to group allocation status (κ = 0.77), and parents completed a questionnaire at baseline and follow-up. Dental therapists trained in MID-ART provided treatment to the Test group and dentists treated the Control group using standard approaches. The primary outcome of interest was the number of children who were referred for specialist pediatric care. Secondary outcomes were the number of teeth treated, changes in child oral health-related quality of life and dental anxiety and parental perceptions of care received. Data were analyzed on an intention to treat basis; risk ratio for referral for specialist care, test of proportions, Wilcoxon rank test and logistic regression were used. Three hundred and seventy parents/carers were initially screened; 273 children were examined at baseline and 254 were randomized (Test = 127; Control = 127): mean age = 3.8 years, SD 0.90; 59% male, mean dmft = 4.9, SD 4.0. There was no statistically significant difference in age, sex, baseline caries experience or child oral health-related quality of life between the Test and Control group. At follow-up (mean interval 11.4 months, SD 3.1 months), 220 children were examined: Test = 115, Control = 105. Case-notes review of 231 children showed Test = 6 (5%) and Control = 53 (49%) were referred for specialist care, P < 0.0001. More teeth were filled in the Test group (mean = 2.93, SD 2.48) than in the Control group (mean = 1.54, SD 2.20), Wilcoxon's test, P < 0.0001. Logistic regression, after controlling for age and baseline caries experience, showed a higher risk of referral by allocation to control group, OR 32.6, 95% CI 10.8-98.4, P < 0.0001. The MID-ART approach reduced significantly the likelihood of referral for specialist care, and more children and teeth were provided with treatment. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A Web-Based Telehealth Training Platform Incorporating Automated Nonverbal Behavior Feedback for Teaching Communication Skills to Medical Students: A Randomized Crossover Study.

PubMed

Liu, Chunfeng; Lim, Renee L; McCabe, Kathryn L; Taylor, Silas; Calvo, Rafael A

2016-09-12

In the interests of patient health outcomes, it is important for medical students to develop clinical communication skills. We previously proposed a telehealth communication skills training platform (EQClinic) with automated nonverbal behavior feedback for medical students, and it was able to improve medical students' awareness of their nonverbal communication. This study aimed to evaluate the effectiveness of EQClinic to improve clinical communication skills of medical students. We conducted a 2-group randomized crossover trial between February and June 2016. Participants were second-year medical students enrolled in a clinical communication skills course at an Australian university. Students were randomly allocated to complete online EQClinic training during weeks 1-5 (group A) or to complete EQClinic training during weeks 8-11 (group B). EQClinic delivered an automated visual presentation of students' nonverbal behavior coupled with human feedback from a standardized patient (SP). All students were offered two opportunities to complete face-to-face consultations with SPs. The two face-to-face consultations were conducted in weeks 6-7 and 12-13 for both groups, and were rated by tutors who were blinded to group allocation. Student-Patient Observed Communication Assessment (SOCA) was collected by blinded assessors (n=28) at 2 time points and also by an SP (n=83). Tutor-rated clinical communications skill in face-to-face consultations was the primary outcome and was assessed with the SOCA. We used t tests to examine the students' performance during face-to-face consultations pre- and postexposure to EQClinic. We randomly allocated 268 medical students to the 2 groups (group A: n=133; group B: n=135). SOCA communication skills measures (score range 4-16) from the first face-to-face consultation were significantly higher for students in group A who had completed EQClinic training and reviewed the nonverbal behavior feedback, compared with group B, who had completed only the course curriculum components (P=.04). Furthermore, at the second face-to-face assessment, the group that completed a teleconsultation between the two face-to-face consultations (group B) showed improved communication skills (P=.005), and the one that had teleconsultations before the first face-to-face consultation (group A) did not show improvement. The EQClinic is a useful tool for medical students' clinical communication skills training that can be applied to university settings to improve students clinical communication skills development.

Methodology Series Module 4: Clinical Trials.

PubMed

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

Methodology Series Module 4: Clinical Trials

PubMed Central

Setia, Maninder Singh

2016-01-01

In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an “open trial.” However, many of the trials are not open – they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India. PMID:27512184

Use of simulation to compare the performance of minimization with stratified blocked randomization.

PubMed

Toorawa, Robert; Adena, Michael; Donovan, Mark; Jones, Steve; Conlon, John

2009-01-01

Minimization is an alternative method to stratified permuted block randomization, which may be more effective at balancing treatments when there are many strata. However, its use in the regulatory setting for industry trials remains controversial, primarily due to the difficulty in interpreting conventional asymptotic statistical tests under restricted methods of treatment allocation. We argue that the use of minimization should be critically evaluated when designing the study for which it is proposed. We demonstrate by example how simulation can be used to investigate whether minimization improves treatment balance compared with stratified randomization, and how much randomness can be incorporated into the minimization before any balance advantage is no longer retained. We also illustrate by example how the performance of the traditional model-based analysis can be assessed, by comparing the nominal test size with the observed test size over a large number of simulations. We recommend that the assignment probability for the minimization be selected using such simulations. Copyright (c) 2008 John Wiley & Sons, Ltd.

Design and challenges of a randomized controlled trial for reducing risk factors of metabolic syndrome in Mexican women through water intake

PubMed Central

Hernández-Cordero, Sonia; González-Castell, Dinorah; Rodríguez-Ramírez, Sonia; Villanueva-Borbolla, María Ángeles; Unar, Mishel; Barquera, Simón; de Cossío, Teresita González; Rivera-Dommarco, Juan; Popkin, Barry M

2014-01-01

Objective To describe the design, methods, and challenges encountered during a randomized clinical trial aimed to promote water intake for reducing risks of metabolic syndrome in Mexican women. Materials and methods In a randomized clinical trial in Cuernavaca, Mexico, overweight and obese (body mass index [BMI] ≥ 25 < 39) women, 18 – < 45 years old with an intake of sugar-sweetened beverages ≥ 250 kilocalories per day (kcal/day) were randomly allocated to the water and education provision group (n = 120) or the education provision only group (n = 120). Results We screened 1 756 women. The main difficulties encountered were identifying participants with the recruitment criteria, delivering water to participants, and the time demanded from the study participants. Conclusions The trial’s main challenges were difficulties surrounding recruitment, delivery of the intervention, and the time demanded from the study participants. Modifications were effectively implemented without jeopardizing the original protocol. PMID:24715012

Designing management strategies for carbon dioxide storage and utilization under uncertainty using inexact modelling

NASA Astrophysics Data System (ADS)

Wang, Yu; Fan, Jie; Xu, Ye; Sun, Wei; Chen, Dong

2017-06-01

Effective application of carbon capture, utilization and storage (CCUS) systems could help to alleviate the influence of climate change by reducing carbon dioxide (CO2) emissions. The research objective of this study is to develop an equilibrium chance-constrained programming model with bi-random variables (ECCP model) for supporting the CCUS management system under random circumstances. The major advantage of the ECCP model is that it tackles random variables as bi-random variables with a normal distribution, where the mean values follow a normal distribution. This could avoid irrational assumptions and oversimplifications in the process of parameter design and enrich the theory of stochastic optimization. The ECCP model is solved by an equilibrium change-constrained programming algorithm, which provides convenience for decision makers to rank the solution set using the natural order of real numbers. The ECCP model is applied to a CCUS management problem, and the solutions could be useful in helping managers to design and generate rational CO2-allocation patterns under complexities and uncertainties.

The Effect of Holly Quran Voice With and Without Translation on Stress, Anxiety and Depression During Pregnancy: A Randomized Controlled Trial.

PubMed

Jabbari, Batoul; Mirghafourvand, Mojgan; Sehhatie, Fahimeh; Mohammad-Alizadeh-Charandabi, Sakineh

2017-05-30

This study aimed to investigate the effect of Holy Quran on stress, anxiety and depression in Iranian pregnant women. A total of 168 participants were allocated randomly into three groups. Group I received broadcast of the Holy Quran with translation, group II received broadcast of the Holy Quran without translation, and group III was the control group. After intervention, scores of perceived stress, state anxiety, trait anxiety and depression in group I and group II were significantly lower compared with the control group. The Holly Quran with translation and without it, both are the effective for reducing stress, anxiety and depression during pregnancy.

Joint Interference Alignment and Power Allocation for K-User Multicell MIMO Channel through Staggered Antenna Switching.

PubMed

Selvaprabhu, Poongundran; Chinnadurai, Sunil; Sarker, Md Abdul Latif; Lee, Moon Ho

2018-01-28

In this paper, we characterise the joint interference alignment (IA) and power allocation strategies for a K -user multicell multiple-input multiple-output (MIMO) Gaussian interference channel. We consider a MIMO interference channel with blind-IA through staggered antenna switching on the receiver. We explore the power allocation and feasibility condition for cooperative cell-edge (CE) mobile users (MUs) by assuming that the channel state information is unknown. The new insight behind the transmission strategy of the proposed scheme is premeditated (randomly generated transmission strategy) and partial cooperative CE MUs, where the transmitter is equipped with a conventional antenna, the receiver is equipped with a reconfigurable multimode antenna (staggered antenna switching pattern), and the receiver switches between preset T modes. Our proposed scheme assists and aligns the desired signals and interference signals to cancel the common interference signals because the received signal must have a corresponding independent signal subspace. The capacity for a K -user multicell MIMO Gaussian interference channel with reconfigurable multimode antennas is completely characterised. Furthermore, we show that the proposed K -user multicell MIMO scheduling and K -user L -cell CEUs partial cooperation algorithms elaborate the generalisation of K -user IA and power allocation strategies. The numerical results demonstrate that the proposed intercell interference scheme with partial-cooperative CE MUs achieves better capacity and signal-to-interference plus noise ratio (SINR) performance compared to noncooperative CE MUs and without intercell interference schemes.

Joint Interference Alignment and Power Allocation for K-User Multicell MIMO Channel through Staggered Antenna Switching

PubMed Central

2018-01-01

In this paper, we characterise the joint interference alignment (IA) and power allocation strategies for a K-user multicell multiple-input multiple-output (MIMO) Gaussian interference channel. We consider a MIMO interference channel with blind-IA through staggered antenna switching on the receiver. We explore the power allocation and feasibility condition for cooperative cell-edge (CE) mobile users (MUs) by assuming that the channel state information is unknown. The new insight behind the transmission strategy of the proposed scheme is premeditated (randomly generated transmission strategy) and partial cooperative CE MUs, where the transmitter is equipped with a conventional antenna, the receiver is equipped with a reconfigurable multimode antenna (staggered antenna switching pattern), and the receiver switches between preset T modes. Our proposed scheme assists and aligns the desired signals and interference signals to cancel the common interference signals because the received signal must have a corresponding independent signal subspace. The capacity for a K-user multicell MIMO Gaussian interference channel with reconfigurable multimode antennas is completely characterised. Furthermore, we show that the proposed K-user multicell MIMO scheduling and K-user L-cell CEUs partial cooperation algorithms elaborate the generalisation of K-user IA and power allocation strategies. The numerical results demonstrate that the proposed intercell interference scheme with partial-cooperative CE MUs achieves better capacity and signal-to-interference plus noise ratio (SINR) performance compared to noncooperative CE MUs and without intercell interference schemes. PMID:29382100

Multiple sensitive estimation and optimal sample size allocation in the item sum technique.

PubMed

Perri, Pier Francesco; Rueda García, María Del Mar; Cobo Rodríguez, Beatriz

2018-01-01

For surveys of sensitive issues in life sciences, statistical procedures can be used to reduce nonresponse and social desirability response bias. Both of these phenomena provoke nonsampling errors that are difficult to deal with and can seriously flaw the validity of the analyses. The item sum technique (IST) is a very recent indirect questioning method derived from the item count technique that seeks to procure more reliable responses on quantitative items than direct questioning while preserving respondents' anonymity. This article addresses two important questions concerning the IST: (i) its implementation when two or more sensitive variables are investigated and efficient estimates of their unknown population means are required; (ii) the determination of the optimal sample size to achieve minimum variance estimates. These aspects are of great relevance for survey practitioners engaged in sensitive research and, to the best of our knowledge, were not studied so far. In this article, theoretical results for multiple estimation and optimal allocation are obtained under a generic sampling design and then particularized to simple random sampling and stratified sampling designs. Theoretical considerations are integrated with a number of simulation studies based on data from two real surveys and conducted to ascertain the efficiency gain derived from optimal allocation in different situations. One of the surveys concerns cannabis consumption among university students. Our findings highlight some methodological advances that can be obtained in life sciences IST surveys when optimal allocation is achieved. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Does distraction reduce the alcohol-aggression relation? A cognitive and behavioral test of the attention-allocation model.

PubMed

Gallagher, Kathryn E; Parrott, Dominic J

2011-06-01

This study provided the first direct test of the cognitive underpinnings of the attention-allocation model and attempted to replicate and extend past behavioral findings for this model as an explanation for alcohol-related aggression. A diverse community sample (55% African American) of men (N = 159) between 21 and 35 years of age (M = 25.80) were randomly assigned to 1 of 2 beverage conditions (i.e., alcohol, no-alcohol control) and 1 of 2 distraction conditions (i.e., distraction, no-distraction). Following beverage consumption, participants were provoked via reception of electric shocks and a verbal insult from a fictitious male opponent. Participants' attention allocation to aggression words (i.e., aggression bias) and physical aggression were measured using a dot probe task and a shock-based aggression task, respectively. Intoxicated men whose attention was distracted displayed significantly lower levels of aggression bias and enacted significantly less physical aggression than intoxicated men whose attention was not distracted. However, aggression bias did not account for the lower levels of alcohol-related aggression in the distraction, relative to the no-distraction, condition. These results replicated and extended past evidence that cognitive distraction is associated with lower levels of alcohol-related aggression in highly provoked males and provide the first known cognitive data to support the attentional processes posited by the attention-allocation model. Discussion focused on how these data inform intervention programming for alcohol-related aggression. (PsycINFO Database Record (c) 2011 APA, all rights reserved).

Does Distraction Reduce the Alcohol-Aggression Relation?: A Cognitive and Behavioral Test of the Attention-Allocation Model

PubMed Central

Gallagher, Kathryn E.; Parrott, Dominic J.

2011-01-01

Objective This study provided the first direct test of the cognitive underpinnings of the attention-allocation model and attempted to replicate and extend past behavioral findings for this model as an explanation for alcohol-related aggression. Method A diverse community sample (55% African-American) of males (N = 159) between 21 and 35 years of age (M = 25.80) were randomly assigned to one of two beverage conditions (i.e., alcohol, no-alcohol control) and one of two distraction conditions (i.e., distraction, no-distraction). Following beverage consumption, participants were provoked via reception of electric shocks and a verbal insult from a fictitious male opponent. Participants’ attention-allocation to aggression words (i.e., aggression bias) and physical aggression were measured using a dot probe task and a shock-based aggression task, respectively. Results Intoxicated men whose attention was distracted displayed significantly lower levels of aggression bias and enacted significantly less physical aggression than intoxicated men whose attention was not distracted. However, aggression bias did not account for the lower levels of alcohol-related aggression in the distraction, relative to the no-distraction, condition. Conclusions These results replicated and extended past evidence that cognitive distraction is associated with lower levels of alcohol-related aggression in highly provoked males and provide the first known cognitive data to support the attentional processes posited by the attention-allocation model. Discussion focused on how these data inform intervention programming for alcohol-related aggression. PMID:21500889

A two-way enriched clinical trial design: combining advantages of placebo lead-in and randomized withdrawal.

PubMed

Ivanova, Anastasia; Tamura, Roy N

2015-12-01

A new clinical trial design, designated the two-way enriched design (TED), is introduced, which augments the standard randomized placebo-controlled trial with second-stage enrichment designs in placebo non-responders and drug responders. The trial is run in two stages. In the first stage, patients are randomized between drug and placebo. In the second stage, placebo non-responders are re-randomized between drug and placebo and drug responders are re-randomized between drug and placebo. All first-stage data, and second-stage data from first-stage placebo non-responders and first-stage drug responders, are utilized in the efficacy analysis. The authors developed one, two and three degrees of freedom score tests for treatment effect in the TED and give formulae for asymptotic power and for sample size computations. The authors compute the optimal allocation ratio between drug and placebo in the first stage for the TED and compare the operating characteristics of the design to the standard parallel clinical trial, placebo lead-in and randomized withdrawal designs. Two motivating examples from different disease areas are presented to illustrate the possible design considerations. © The Author(s) 2011.

A Bayesian sequential design with adaptive randomization for 2-sided hypothesis test.

PubMed

Yu, Qingzhao; Zhu, Lin; Zhu, Han

2017-11-01

Bayesian sequential and adaptive randomization designs are gaining popularity in clinical trials thanks to their potentials to reduce the number of required participants and save resources. We propose a Bayesian sequential design with adaptive randomization rates so as to more efficiently attribute newly recruited patients to different treatment arms. In this paper, we consider 2-arm clinical trials. Patients are allocated to the 2 arms with a randomization rate to achieve minimum variance for the test statistic. Algorithms are presented to calculate the optimal randomization rate, critical values, and power for the proposed design. Sensitivity analysis is implemented to check the influence on design by changing the prior distributions. Simulation studies are applied to compare the proposed method and traditional methods in terms of power and actual sample sizes. Simulations show that, when total sample size is fixed, the proposed design can obtain greater power and/or cost smaller actual sample size than the traditional Bayesian sequential design. Finally, we apply the proposed method to a real data set and compare the results with the Bayesian sequential design without adaptive randomization in terms of sample sizes. The proposed method can further reduce required sample size. Copyright © 2017 John Wiley & Sons, Ltd.

Influence of antibiotic prophylaxis on the stability of orthodontic microimplants: A pilot randomized controlled trial.

PubMed

Łyczek, Jan; Kawala, Beata; Antoszewska-Smith, Joanna

2018-05-01

The aims of this 2-arm parallel pilot randomized controlled trial were to investigate the influence of antibiotic prophylaxis on the stability of orthodontic microimplants and to evaluate the efficacy of systemic inflammatory marker measurements in detecting infections in tissues surrounding microscrews. Orthodontic patients requiring en-masse distalization in the maxilla received antibiotics or a placebo before microimplant placement. Eligibility criteria included 13 years of age, and good general and oral health. Exclusion criteria comprised allergy to antibiotics, severe systemic allergy, heart and kidney diseases, and recent antibiotic treatment. Stability of the microimplants was the primary outcome; inflammation of the tissues surrounding the microscrews, pain related to the microimplantation, and serum levels of inflammatory markers were the secondary outcomes. Randomization in a 1:1 ratio was performed by auxilliary staff via a flip of a coin between 2 participants of the same sex and developmental stage, and the "winner" was allocated to the intervention group. Pharmaceutically prepared identical capsules with either amoxicillin (intervention) or glucose (control) given 1 hour before microimplant placement according to the allocation provided blinding of the participants. Subsequently, 1 clinician unaware of the allocation inserted the microimplants and assessed the outcomes, which simultaneously blinded the operator-assessor. Blood samples for laboratory analysis of inflammatory markers were collected a day before and 1, 3, and 7 days postoperatively. Out of 80 participants initially assessed for eligibility, 41 received the randomized allocation. Three patients were lost to follow-up. Eventually, data of 18 and 20 participants (mean age, 20.4 ± 5.9 years) were available for analysis in the intervention and control groups, in which 1 and 2 patients lost a microimplant, respectively, resulting in odds ratio of 0.53 (95% confidence interval [CI], 0.0084-11.23; P = 1.0). The odds ratio for inflammation development was 1.22 (95% CI, 0.34-4.38), and the odds ratio for feeling milder pain was 1.174 (95% CI, 0.350-3.941) in the intervention compared with the control group, but the result was not statistically significant (P = 0.758; P = 0.795, respectively). The inflammatory marker levels did not increase due to either microimplantation (procalcitonin, P = 0.445; C-reactive protein, P = 0.4) or peri-implantitis. Antibiotic prophylaxis slightly decreased the levels of the biomarkers in the intervention group; however, the results were not statistically significant (P = 0.68; P = 0.908, respectively). No harms caused by the microimplantation procedure or drug intake were noted. Antibiotics provided no benefit in terms of microimplant stability, inflammation of soft tissues, or postoperative pain in our pilot sample. Measurements of serum levels of inflammatory markers were inefficient in detecting soft tissue inflammations. These initial results should be interpreted with caution until validated by a large multicenter definitive trial. This trial was not registered. The protocol was not published before trial commencement. The trial was funded by Wroclaw Medical University; grant number pbmn91 and supported by Diagnostyka. Copyright © 2018 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial.

PubMed

Gray, Richard; Ives, Natalie; Rick, Caroline; Patel, Smitaa; Gray, Alastair; Jenkinson, Crispin; McIntosh, Emma; Wheatley, Keith; Williams, Adrian; Clarke, Carl E

2014-09-27

Whether initial treatment for Parkinson's disease should consist of levodopa, dopamine agonists, or monoamine oxidase type B inhibitors (MAOBI) is uncertain. We aimed to establish which of these three classes of drug, as initial treatment, provides the most effective long-term control of symptoms and best quality of life for people with early Parkinson's disease. In this pragmatic, open-label randomised trial, patients newly diagnosed with Parkinson's disease were randomly assigned (by telephone call to a central office; 1:1:1) between levodopa-sparing therapy (dopamine agonists or MAOBI) and levodopa alone. Patients and investigators were not masked to group assignment. Primary outcomes were the mobility dimension on the 39-item patient-rated Parkinson's disease questionnaire (PDQ-39) quality-of-life scale (range 0-100 with six points defined as the minimally important difference) and cost-effectiveness. Analysis was intention to treat. This trial is registered, number ISRCTN69812316. Between Nov 9, 2000, and Dec 22, 2009, 1620 patients were assigned to study groups (528 to levodopa, 632 to dopamine agonist, 460 to MAOBI). With 3-year median follow-up, PDQ-39 mobility scores averaged 1·8 points (95% CI 0·5-3·0, p=0·005) better in patients randomly assigned to levodopa than those assigned to levodopa-sparing therapy, with no increase or attrition of benefit during 7 years' observation. PDQ-39 mobility scores were 1·4 points (95% CI 0·0-2·9, p=0·05) better in patients allocated MAOBI than in those allocated dopamine agonists. EQ-5D utility scores averaged 0·03 (95% CI 0·01-0·05; p=0·0002) better with levodopa than with levodopa-sparing therapy; rates of dementia (hazard ratio [HR] 0·81, 95% CI 0·61-1·08, p=0·14), admissions to institutions (0·86, 0·63-1·18; p=0·4), and death (0·85, 0·69-1·06, p=0·17) were not significantly different, but the upper CIs precluded any substantial increase with levodopa compared with levodopa-sparing therapy. 179 (28%) of 632 patients allocated dopamine agonists and 104 (23%) of 460 patients allocated MAOBI discontinued allocated treatment because of side-effects compared with 11 (2%) of 528 patients allocated levodopa (p<0·0001). Very small but persistent benefits are shown for patient-rated mobility scores when treatment is initiated with levodopa compared with levodopa-sparing therapy. MAOBI as initial levodopa-sparing therapy was at least as effective as dopamine agonists. UK National Institute for Health Research Health Technology Assessment Programme and UK Department of Health. Copyright © 2014 Elsevier Ltd. All rights reserved.

Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial.

PubMed

Paramsothy, Sudarshan; Kamm, Michael A; Kaakoush, Nadeem O; Walsh, Alissa J; van den Bogaerde, Johan; Samuel, Douglas; Leong, Rupert W L; Connor, Susan; Ng, Watson; Paramsothy, Ramesh; Xuan, Wei; Lin, Enmoore; Mitchell, Hazel M; Borody, Thomas J

2017-03-25

The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis. We conducted a multicentre, double-blind, randomised, placebo-controlled trial at three hospitals in Australia. We randomly allocated patients with active ulcerative colitis (Mayo score 4-10) in a 1:1 ratio, using a pre-established randomisation list, to either faecal microbiota transplantation or placebo colonoscopic infusion, followed by enemas 5 days per week for 8 weeks. Patients, treating clinicians, and other study staff were unaware of the assigned treatment. Faecal microbiota transplantation enemas were each derived from between three and seven unrelated donors. The primary outcome was steroid-free clinical remission with endoscopic remission or response (Mayo score ≤2, all subscores ≤1, and ≥1 point reduction in endoscopy subscore) at week 8. Analysis was by modified intention-to-treat and included all patients receiving one study dose. We performed 16S rRNA stool analysis to assess associated microbial changes. This trial is registered with ClinicalTrials.gov, number NCT01896635. The trial has ended; this report presents the final analysis. From November, 2013, to May, 2015, 85 patients were enrolled to our trial, of whom 42 were randomly assigned faecal microbiota transplantation and 43 were allocated placebo. One patient assigned faecal microbiota transplantation and three allocated placebo did not receive study treatment and were excluded from the analysis. The primary outcome was achieved in 11 (27%) of 41 patients allocated faecal microbiota transplantation versus three (8%) of 40 who were assigned placebo (risk ratio 3·6, 95% CI 1·1-11·9; p=0·021). Adverse events were reported by 32 (78%) of 41 patients allocated faecal microbiota transplantation and 33 (83%) of 40 who were assigned placebo; most were self-limiting gastrointestinal complaints, with no significant difference in number or type of adverse events between treatment groups. Serious adverse events occurred in two patients assigned faecal microbiota transplantation and in one allocated placebo. Microbial diversity increased with and persisted after faecal microbiota transplantation. Several bacterial taxa were associated with clinical outcome; in particular, the presence of Fusobacterium spp was associated with lack of remission. Intensive-dosing, multidonor, faecal microbiota transplantation induces clinical remission and endoscopic improvement in active ulcerative colitis and is associated with distinct microbial changes that relate to outcome. Faecal microbiota transplantation is, thus, a promising new therapeutic option for ulcerative colitis. Future work should focus on precisely defining the optimum treatment intensity and the role of donor-recipient matching based on microbial profiles. Broad Medical Research Program, Gastroenterological Society of Australia, Mount Sinai (New York) SUCCESS fund, University of New South Wales. Copyright © 2017 Elsevier Ltd. All rights reserved.

Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

PubMed

Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

2015-01-01

This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study. Copyright © 2015 Elsevier Inc. All rights reserved.

Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

PubMed

Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

2014-08-01

Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

Proton Pump Inhibitors Decrease Phlebotomy Need in HFE Hemochromatosis: Double-Blind Randomized Placebo-Controlled Trial.

PubMed

Vanclooster, Annick; van Deursen, Cees; Jaspers, Reggy; Cassiman, David; Koek, Ger

2017-09-01

Phlebotomy constitutes the established treatment for HFE-related hemochromatosis. Retrospective studies have suggested proton pump inhibitors (PPIs) reduce the need for phlebotomy in this population. We conducted a randomized controlled trial to prove this. Thirty p.C282Y homozygous patients were randomly allocated to PPI (pantoprazole 40 mg/day) or placebo for 12 months. Phlebotomies were performed when serum ferritin was > 100 μg/L. Phlebotomy need turned out to be significantly lower in patients taking PPI (P = .0052). PPI treatment significantly reduces the need for phlebotomies in p.C282Y homozygous patients. In view of the known long-term safety profile of PPI, they can be a valuable addition to standard therapy. Clinicaltrials.gov: NCT01524757. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Variances and uncertainties of the sample laboratory-to-laboratory variance (S(L)2) and standard deviation (S(L)) associated with an interlaboratory study.

PubMed

McClure, Foster D; Lee, Jung K

2012-01-01

The validation process for an analytical method usually employs an interlaboratory study conducted as a balanced completely randomized model involving a specified number of randomly chosen laboratories, each analyzing a specified number of randomly allocated replicates. For such studies, formulas to obtain approximate unbiased estimates of the variance and uncertainty of the sample laboratory-to-laboratory (lab-to-lab) STD (S(L)) have been developed primarily to account for the uncertainty of S(L) when there is a need to develop an uncertainty budget that includes the uncertainty of S(L). For the sake of completeness on this topic, formulas to estimate the variance and uncertainty of the sample lab-to-lab variance (S(L)2) were also developed. In some cases, it was necessary to derive the formulas based on an approximate distribution for S(L)2.

Effects of a resistance training program on balance and fatigue perception in patients with Parkinson's disease: A randomized controlled trial.

PubMed

Ortiz-Rubio, Araceli; Cabrera-Martos, Irene; Torres-Sánchez, Irene; Casilda-López, Jesús; López-López, Laura; Valenza, Marie Carmen

2017-11-22

Fatigue and balance impairment leads to a loss of independence and are important to adequately manage. The objective of this study was to examine the effects of a resistance training program on dynamic balance and fatigue in patients with Parkinson's disease (PD). Randomized controlled trial. Forty-six patients with PD were randomly allocated to an intervention group receiving a 8-week resistance training program focused on lower limbs or to a control group. Balance was assessed using the Mini-BESTest and fatigue was assessed by the Piper Fatigue Scale. Patients in the intervention group improved significantly (p<0.05) on dynamic balance (reactive postural control and total values) and perceived fatigue. An 8-week resistance training program was found to be effective at improving dynamic balance and fatigue in patients with PD. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Smartphone app design for the wireless control of a neuromuscular electrical stimulator device with integrated randomization allocation process for RCT applications.

PubMed

Sweeney, Dean; Quinlan, Leo R; OLaighin, Gearoid

2015-08-01

The use of NMES has evolved over the last five decades. Technological advancements have transformed these once complex systems into user-friendly devices with enhanced control functions, leading to new applications of NMES being investigated. The use of Randomized Control Trial (RCT) methodology in evaluating the effectiveness of new and existing applications of NMES is a demanding process adding time and cost to a translation into clinical practice. Poor quality trials may result in poor evidence of NMES effectiveness. In this paper some of the key challenges encountered in NMES clinical trials are identified with the aim of purposing a solution to address these challenges through the adoption of Smartphone technology. The design and evaluation of a smartphone application to provide automatic blind randomization control and facilitating the wireless temporal control of a portable Bluetooth enabled NMES is presented.

Cognitive Aspects and Behavioral Effects of Transitions Between Levels of Automation

DTIC Science & Technology

2007-01-06

operator’s mental load: − changes in performance due to the allocation of resources to multiple tasks; − operator’s self-reports (e.g., NASA - TLX , SWAT...difficulty was randomized across participants. After each block participants compiled the NASA -Task Load indeX ( NASA - TLX : Hart & Staveland, 1988) for...the subjective assessment of mental workload. DATA ANALYSIS AND RESULTS NASA - TLX weighted scores and number of completed lines (an index of

Cryotherapy versus electrocautery in the treatment of genital warts.

PubMed Central

Simmons, P D; Langlet, F; Thin, R N

1981-01-01

Forty-two male patients with ano-genital warts were randomly allocated to a single-blind study of cryotherapy versus electrocautery. There was no significant difference in the success rates of these two forms of treatment in patients followed for three months. Cryotherapy was qualitatively much more acceptable to the patients than electrocautery. It seems particularly suited to patients with widely scattered warts who are unable to attend for regular treatment. PMID:7272706

Can Using Rigorous Evidence to Guide Federal Education Funds Improve Student Achievement? Randomized Trials Show Encouraging Initial Results for DoED's Investing in Innovation Fund

ERIC Educational Resources Information Center

Coalition for Evidence-Based Policy, 2014

2014-01-01

An important recent development in evidence-based policy is the federal government's use of a "tiered evidence" approach to allocating funding in grant programs such as the U.S. Department of Education's Investing in Innovation Fund (i3). A central feature of this approach is that the largest grants are awarded to fund large-scale…

Virtual volatility

NASA Astrophysics Data System (ADS)

Silva, A. Christian; Prange, Richard E.

2007-03-01

We introduce the concept of virtual volatility. This simple but new measure shows how to quantify the uncertainty in the forecast of the drift component of a random walk. The virtual volatility also is a useful tool in understanding the stochastic process for a given portfolio. In particular, and as an example, we were able to identify mean reversion effect in our portfolio. Finally, we briefly discuss the potential practical effect of the virtual volatility on an investor asset allocation strategy.

The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial.

PubMed

Rodrigues, Marcela Perdomo; Dos Santos, Luciana Kaercher John; Fuchs, Flavio Danni; Fuchs, Sandra Costa; Moreira, Leila Beltrami

2017-07-21

The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the ability of overcoming obstacles regarding sodium-restriction behavior. The present study aims to describe the protocol and randomization of a clinical trial design in order to evaluate the effectiveness of an educational intervention based on Dietary Sodium Restriction Questionnaire (DSRQ) scores. The effectiveness measures are the DSRQ score variation and reduction in urinary sodium values from baseline to after 2 and 6 months. This parallel, randomized clinical trial will include 120 participants, recruited and randomized as follows: 60 of them to be allocated to a sodium-restriction educational intervention group whose results are based on the DSRQ application; and the other 60 allocated to a control group with usual care. Educational orientation and usual care sessions will be conducted once a month for a period of 6 months. Both spot urine collection - estimating sodium intake - and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. There will also be blood collection and 24-h ambulatory blood pressure monitoring (ABPM) at the beginning and end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-h food recall will be collected during follow-up. The study "The effectiveness of an educational intervention to sodium restriction in patients with hypertension" is based on the results of the DSRQ application, whose objective is to evaluate aspects related to nonadherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, hypertension control. ClinicalTrials.gov, Identifier: NCT02848690 . Registered retrospectively on 27 July 2016.

Comprehensive geriatric intervention program with and without weekly class-style exercise: research protocol of a cluster randomized controlled trial in Kyoto-Kameoka Study

PubMed Central

Yoshida, Tsukasa; Yoshinaka, Yasuko; Yoshimoto, Mie; Tanaka, Yoko; Itoi, Aya; Yamagata, Emi; Ebine, Naoyuki; Ishikawa-Takata, Kazuko; Kimura, Misaka

2018-01-01

Objective The number of long-term care (LTC) users and the associated expenditures in Japan are increasing dramatically. The national government recommends LTC prevention through activation of communities. However, there is no clear evidence of the effect of population-based comprehensive geriatric intervention program (CGIP) for restraints of LTC users and the associated expenditures in the future. The aims of the current paper are to describe the study protocol and progress of a cluster randomized controlled trial (RCT) with a CGIP in Kameoka City. Methods The cluster RCT involved random allocation of regions as intervention (n=4,859) and nonintervention (n=7,195). Participants were elderly persons aged ≥65 years without LTC certification who had responded to a mailing survey. The residents living in intervention regions were invited to a physical check-up, and 1,463 people participated (30.3%). These individuals were invited to the CGIP, and 526 accepted. The CGIP comprised instructions on: 1) low-load resistance training using bodyweight, ankle weights, and elastic bands; 2) increasing daily physical activity; 3) oral motor exercise and care; and 4) a well-balanced diet based on a program from Ministry of Health, Labour and Welfare. We allocated the intervention regions randomly into home-based self-care program alone (HB group, 5 regions, n=275) and home-based program+weekly class-style session (CS group, 5 regions, n=251). We evaluated the effects of the CGIP at 12 weeks and at 12 or 15 months on physical function, and are conducting follow-up data collection for an indefinite period regarding LTC certification, medical costs, and mortality. Results and discussion The study was launched with good response rates in each phase. Participants of both groups significantly increased their step counts by ~1,000 per day from the baseline during the CGIP. This RCT will provide valuable information and evidence about effectiveness of a community-based CGIP. PMID:29872280

Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial.

PubMed

Belgaid, Djouhar Roufeida; Khan, Zara; Zaidi, Mariam; Hobbs, Adrian

2016-09-15

Assessing the safety and effectiveness of left atrial appendage (LAA) (pouch found in the upper chambers of the heart) occlusion, using the Watchman device compared to long term warfarin therapy (drug that reduces clot formation), in preventing the risk of stroke in patients with atrial fibrillation (most common type of irregular heart beat). 90% of strokes in atrial fibrillation arise from clots forming in this pouch. By mechanically blocking it using the device less clots are suggested to be formed. This is an alternative to taking warfarin especially in patients who cannot take it. 50 sites in the United States enrolled 407 participants. After being randomly allocated, the device group had 269 participants and warfarin group (comparator)had 138 participants. Patients with atrial fibrillation and at high risk of stroke were randomly allocated a group after they were deemed eligible. Patients in the device group had to take warfarin and aspirin for 45days till the complete closure of the LAA. The oral anticoagulant was followed by dual antiplatelet therapy until 6months and then ASA. Patients in the warfarin group have to take it for life and were continually monitored. The study ran for 26months. The trial assessed the rate of adverse events using three endpoints: The PREVAIL trial was not designed to show superiority, but non-inferiority. It met the safety endpoint and one efficacy endpoint for the watchman device compared to long term warfarin for overall efficacy of the device. The results established that LAA occlusion is not worse than warfarin intake for the prevention of stroke more than 1week after randomization. Compared to previous trials, the safety of the device has also improved. LAA occlusion is a reasonable alternative to chronic warfarin therapy in stroke prevention for patients with atrial fibrillation. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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

2010-08-01

To evaluate implant and prosthesis movement after myoconjunctival enucleation and subsequent polymethyl methacrylate (PMMA) implantation, compared with the traditional enucleation with muscle imbrication using a PMMA implant and with enucleation accompanied by porous polyethylene implantation. Randomized, controlled, observer-masked, interventional study. One hundred fifty patients, equally and randomly allocated to the 3 groups. Group 1 consisted of patients in whom a PMMA implant was used after enucleation with muscle imbrication (traditional PMMA group). Group 2 consisted of patients in whom a PMMA implant was used after enucleation with a myoconjunctival technique (myoconjunctival PMMA group). Group 3 consisted of patients in whom a porous polyethylene implant was used after enucleation by the scleral cap technique (porous polyethylene group). Fifty patients were included in each group. Patients were allocated to 1 of the 3 groups using stratified randomization. Informed consent was obtained. Acrylic prostheses custom made by a trained ocularist were fitted 6 weeks after surgery in all patients. A masked observer measured implant and prosthesis movement 6 weeks after surgery using a slit-lamp device with real-time video and still photographic documentation. Analysis of implant and prosthesis movement was carried out using the Mann-Whitney U test, and a P value of < or =0.03 was considered significant. Complications including implant displacement and exposure also were noted. Implant and prosthesis movement. Myoconjunctival PMMA implant movement was better than the traditional PMMA implant (P = 0.001), but was similar to that of the porous polyethylene implant. Prosthesis movement with the myoconjunctival PMMA implant was better than that of either the traditional PMMA (P = 0.001) or porous polyethylene (P = 0.002) implants. Myoconjunctival enucleation technique with a PMMA implant provides statistically and clinically significantly better implant and prosthesis movement than the traditional PMMA implant and better prosthesis movement than the porous polyethylene implant. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2017-08-23

The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer. An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization. From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74). Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression. Clinical Trials identifier NCT02133274 . Registered May 6, 2014.

Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials.

PubMed

Meropol, Neal J; Wong, Yu-Ning; Albrecht, Terrance; Manne, Sharon; Miller, Suzanne M; Flamm, Anne Lederman; Benson, Al Bowen; Buzaglo, Joanne; Collins, Michael; Egleston, Brian; Fleisher, Linda; Katz, Michael; Kinzy, Tyler G; Liu, Tasnuva M; Margevicius, Seunghee; Miller, Dawn M; Poole, David; Roach, Nancy; Ross, Eric; Schluchter, Mark D

2016-02-10

Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient's barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers. © 2015 by American Society of Clinical Oncology.

Blastocyst utilization rates after continuous culture in two commercial single-step media: a prospective randomized study with sibling oocytes.

PubMed

Sfontouris, Ioannis A; Kolibianakis, Efstratios M; Lainas, George T; Venetis, Christos A; Petsas, George K; Tarlatzis, Basil C; Lainas, Tryfon G

2017-10-01

The aim of this study is to determine whether blastocyst utilization rates are different after continuous culture in two different commercial single-step media. This is a paired randomized controlled trial with sibling oocytes conducted in infertility patients, aged ≤40 years with ≥10 oocytes retrieved assigned to blastocyst culture and transfer. Retrieved oocytes were randomly allocated to continuous culture in either Sage one-step medium (Origio) or Continuous Single Culture (CSC) medium (Irvine Scientific) without medium renewal up to day 5 post oocyte retrieval. Main outcome measure was the proportion of embryos suitable for clinical use (utilization rate). A total of 502 oocytes from 33 women were randomly allocated to continuous culture in either Sage one-step medium (n = 250) or CSC medium (n = 252). Fertilization was performed by either in vitro fertilization or intracytoplasmic sperm injection, and embryo transfers were performed on day 5. Two patients had all blastocysts frozen due to the occurrence of severe ovarian hyperstimulation syndrome. Fertilization and cleavage rates, as well as embryo quality on day 3, were similar in the two media. Blastocyst utilization rates (%, 95% CI) [55.4% (46.4-64.1) vs 54.7% (44.9-64.6), p = 0.717], blastocyst formation rates [53.6% (44.6-62.5) vs 51.9 (42.2-61.6), p = 0.755], and proportion of good quality blastocysts [36.8% (28.1-45.4) vs 36.1% (27.2-45.0), p = 0.850] were similar in Sage one-step and CSC media, respectively. Continuous culture of embryos in Sage one-step and CSC media is associated with similar blastocyst development and utilization rates. Both single-step media appear to provide adequate support during in vitro preimplantation embryo development. Whether these observations are also valid for other continuous single medium protocols remains to be determined. NCT02302638.

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.

Impact of aspirin resistance on outcomes among patients following coronary artery bypass grafting: exploratory analysis from randomized controlled trial (NCT01159639).

PubMed

Petricevic, Mate; Kopjar, Tomislav; Gasparovic, Hrvoje; Milicic, Davor; Svetina, Lucija; Zdilar, Boris; Boban, Marko; Mihaljevic, Martina Zrno; Biocina, Bojan

2015-05-01

Individual variability in the response to aspirin, has been established by various platelet function assays, however, the clinical relevance of aspirin resistance (AR) in patients undergoing coronary artery bypass grafting (CABG) has to be evaluated. Our working group conducted a randomized controlled trial (NCT01159639) with the aim to assess impact of dual antiplatelet therapy (APT) on outcomes among patients with AR following CABG. Patients that were aspirin resistant on fourth postoperative day (POD 4) were randomly assigned to receive either dual APT with clopidogrel (75 mg) plus aspirin (300 mg)-intervention arm or monotherapy with aspirin (300 mg)-control arm. This exploratory analysis compares clinical outcomes between aspirin resistant patients allocated to control arm and patients that have had adequate platelet inhibitory response to aspirin at POD 4. Both groups were treated with 300 mg of aspirin per day following surgery. We sought to evaluate the impact of early postoperative AR on outcomes among patients following CABG. Exploratory analysis included a total number of 325 patients. Of those, 215 patients with adequate response to aspirin and 110 patients with AR allocated to aspirin monotherapy following randomization protocol. The primary efficacy end point (MACCEs-major adverse cardiac and cardiovascular events) occurred in 10 and 6 % of patients with AR and with adequate aspirin response, respectively (p = 0.27). Non-significant differences were observed in bleeding events occurrence. Subgroup analysis of the primary end point revealed that aspirin resistant patients with BMI > 30 kg/m(2) tend to have a higher occurrence of MACCEs 18 versus 5 % (relative risk 0.44 [95 % CI 0.16-1.16]; p = 0.05). This exploratory analysis did not reveal significant impact of aspirin resistance on outcomes among patients undergoing CABG. Further, sufficiently powered studies are needed in order to evaluate clinical relevance of AR in patients undergoing CABG.

Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty.

PubMed

Golpanian, Samuel; DiFede, Darcy L; Pujol, Marietsy V; Lowery, Maureen H; Levis-Dusseau, Silvina; Goldstein, Bradley J; Schulman, Ivonne H; Longsomboon, Bangon; Wolf, Ariel; Khan, Aisha; Heldman, Alan W; Goldschmidt-Clermont, Pascal J; Hare, Joshua M

2016-03-15

Frailty is a syndrome associated with reduced physiological reserves that increases an individual's vulnerability for developing increased morbidity and/or mortality. While most clinical trials have focused on exercise, nutrition, pharmacologic agents, or a multifactorial approach for the prevention and attenuation of frailty, none have studied the use of cell-based therapies. We hypothesize that the application of allogeneic human mesenchymal stem cells (allo-hMSCs) as a therapeutic agent for individuals with frailty is safe and efficacious. The CRATUS trial comprises an initial non-blinded phase I study, followed by a blinded, randomized phase I/II study (with an optional follow-up phase) that will address the safety and pre-specified beneficial effects in patients with the aging frailty syndrome. In the initial phase I protocol, allo-hMSCs will be administered in escalating doses via peripheral intravenous infusion (n=15) to patients allocated to three treatment groups: Group 1 (n=5, 20 million allo-hMSCs), Group 2 (n=5, 100 million allo-hMSCs), and Group 3 (n=5, 200 million allo-hMSCs). Subsequently, in the randomized phase, allo-hMSCs or matched placebo will be administered to patients (n=30) randomly allocated in a 1:1:1 ratio to one of two doses of MSCs versus placebo: Group A (n=10, 100 million allo-hMSCs), Group B (n=10, 200 million allo-hMSCs), and Group C (n=10, placebo). Primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCs administered in frail older individuals. This study will determine the safety of intravenous infusion of stem cells and compare phenotypic outcomes in patients with aging frailty.

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

Cost-effectiveness of health research study participant recruitment strategies: a systematic review.

PubMed

Huynh, Lynn; Johns, Benjamin; Liu, Su-Hsun; Vedula, S Swaroop; Li, Tianjing; Puhan, Milo A

2014-10-01

A large fraction of the cost of conducting clinical trials is allocated to recruitment of participants. A synthesis of findings from studies that evaluate the cost and effectiveness of different recruitment strategies will inform investigators in designing cost-efficient clinical trials. To systematically identify, assess, and synthesize evidence from published comparisons of the cost and yield of strategies for recruitment of participants to health research studies. We included randomized studies in which two or more strategies for recruitment of participants had been compared. We focused our economic evaluation on studies that randomized participants to different recruitment strategies. We identified 10 randomized studies that compared recruitment strategies, including monetary incentives (cash or prize), direct contact (letters or telephone call), and medical referral strategies. Only two of the 10 studies compared strategies for recruiting participants to clinical trials. We found that allocating additional resources to recruit participants using monetary incentives or direct contact yielded between 4% and 23% additional participants compared to using neither strategy. For medical referral, recruitment of prostate cancer patients by nurses was cost-saving compared to recruitment by consultant urologists. For all underlying study designs, monetary incentives cost more than direct contact with potential participants, with a median incremental cost per recruitment ratio of Int$72 (Int$-International dollar, a theoretical unit of currency) for monetary incentive strategy compared to Int$28 for direct contact strategy. Only monetary incentives and source of referral were evaluated for recruiting participants into clinical trials. We did not review studies that presented non-monetary cost or lost opportunity cost. We did not adjust for the number of study recruitment sites or the study duration in our economic evaluation analysis. Systematic and explicit reporting of cost and effectiveness of recruitment strategies from randomized comparisons is required to aid investigators to select cost-efficient strategies for recruiting participants to health research studies including clinical trials. © The Author(s) 2014.

Optimum allocation for a dual-frame telephone survey.

PubMed

Wolter, Kirk M; Tao, Xian; Montgomery, Robert; Smith, Philip J

2015-12-01

Careful design of a dual-frame random digit dial (RDD) telephone survey requires selecting from among many options that have varying impacts on cost, precision, and coverage in order to obtain the best possible implementation of the study goals. One such consideration is whether to screen cell-phone households in order to interview cell-phone only (CPO) households and exclude dual-user household, or to take all interviews obtained via the cell-phone sample. We present a framework in which to consider the tradeoffs between these two options and a method to select the optimal design. We derive and discuss the optimum allocation of sample size between the two sampling frames and explore the choice of optimum p , the mixing parameter for the dual-user domain. We illustrate our methods using the National Immunization Survey , sponsored by the Centers for Disease Control and Prevention.

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

PubMed

Staniland, Jessica J; Byrne, Mitchell K

2013-12-01

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

Kinetics of matching.

PubMed

Mark, T A; Gallistel, C R

1994-01-01

Rats responded on concurrent variable interval schedules of brain stimulation reward in 2-trial sessions. Between trials, there was a 16-fold reversal in the relative rate of reward. In successive, narrow time windows, the authors compared the ratio of the times spent on the 2 levers to the ratio of the rewards received. Time-allocation ratios tracked wide, random fluctuations in the reward ratio. The adjustment to the midsession reversal in relative rate of reward was largely completed within 1 interreward interval on the leaner schedule. Both results were unaffected by a 16-fold change in the combined rates of reward. The large, rapid, scale-invariant shifts in time-allocation ratios that underlie matching behavior imply that the subjective relative rate of reward can be determined by a very few of the most recent interreward intervals and that this estimate can directly determine the ratio of the expected stay durations.

Methodological Reporting of Randomized Trials in Five Leading Chinese Nursing Journals

PubMed Central

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Background Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. Methods In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. Results In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34±0.97 (Mean ± SD). No RCT reported descriptions and changes in “trial design,” changes in “outcomes” and “implementation,” or descriptions of the similarity of interventions for “blinding.” Poor reporting was found in detailing the “settings of participants” (13.1%), “type of randomization sequence generation” (1.8%), calculation methods of “sample size” (0.4%), explanation of any interim analyses and stopping guidelines for “sample size” (0.3%), “allocation concealment mechanism” (0.3%), additional analyses in “statistical methods” (2.1%), and targeted subjects and methods of “blinding” (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of “participants,” “interventions,” and definitions of the “outcomes” and “statistical methods.” The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. Conclusions The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods. PMID:25415382

Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial.

PubMed

Ridd, Matthew J; Redmond, Niamh M; Hollinghurst, Sandra; Ball, Nicola; Shaw, Lindsay; Guy, Richard; Wilson, Victoria; Metcalfe, Chris; Purdy, Sarah

2015-07-15

Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for 'flares', such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time? This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants. Recruitment is on-going. At the end of the study, as well as being able to answer the question, 'Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?', we will also have collected important data on the acceptability and effectiveness of four commonly used emollients. Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.

Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial.

PubMed

Alfawal, Alaa M H; Hajeer, Mohammad Y; Ajaj, Mowaffak A; Hamadah, Omar; Brad, Bassel

2018-02-17

To evaluate the effectiveness of two minimally invasive surgical procedures in the acceleration of canine retraction: piezocision and laser-assisted flapless corticotomy (LAFC). Trial design: A single-centre randomized controlled trial with a compound design (two-arm parallel-group design and a split-mouth design for each arm). 36 Class II division I patients (12 males, 24 females; age range: 15 to 27 years) requiring first upper premolars extraction followed by canine retraction. piezocision group (PG; n = 18) and laser-assisted flapless corticotomy group (LG; n = 18). A split-mouth design was applied for each group where the flapless surgical intervention was randomly allocated to one side and the other side served as a control side. the rate of canine retraction (primary outcome), anchorage loss and canine rotation, which were assessed at 1, 2, 3 and 4 months following the onset of canine retraction. Also the duration of canine retraction was recorded. Random sequence: Computer-generated random numbers. Allocation concealment: sequentially numbered, opaque, sealed envelopes. Blinding: Single blinded (outcomes' assessor). Seventeen patients in each group were enrolled in the statistical analysis. The rate of canine retraction was significantly greater in the experimental side than in the control side in both groups by two-fold in the first month and 1.5-fold in the second month (p < 0.001). Also the overall canine retraction duration was significantly reduced in the experimental side as compared with control side in both groups about 25% (p ≤ 0.001). There were no significant differences between the experimental and the control sides regarding loss of anchorage and upper canine rotation in both groups (p > 0.05). There were no significant differences between the two flapless techniques regarding the studied variables during all evaluation times (p > 0.05). Piezocision and laser-assisted flapless corticotomy appeared to be effective treatment methods for accelerating canine retraction without any significant untoward effect on anchorage or canine rotation during rapid retraction. ClinicalTrials.gov (Identifier: NCT02606331 ).

Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom.

PubMed

Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth

2011-10-01

Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

Community-wide promotion of physical activity in middle-aged and older Japanese: a 3-year evaluation of a cluster randomized trial.

PubMed

Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Harada, Kazuhiro; Lee, I-Min; Bauman, Adrian; Miyachi, Motohiko

2015-06-23

Promotion of physical activity (PA) is a key strategy to prevent non-communicable diseases. However, evidence on the effectiveness of community-wide interventions (CWIs) for promoting PA is limited. To evaluate the effectiveness of a 3-year CWI for promoting PA in middle-aged and older adults compared with usual public health services. This study is an extension to an original 1-year investigation study. Cluster randomized controlled trial with community as unit of randomization and individual as unit of analysis. 12 communities in Unnan, Japan were randomly allocated to the intervention (9) or the control (3). Additionally intervention communities were randomly allocated to aerobic activity promotion (Group A), flexibility and muscle-strengthening activities promotion (Group FM), or aerobic, flexibility, and muscle-strengthening activities promotion (Group AFM), each consisting of three communities. Randomly-sampled 4414 residents aged 40 to 79 years responded to the baseline survey (74%), and were analyzed in 2013-2014. A 3-year CWI based on social marketing, to promote PA from 2009 to 2012. The primary outcome was a change in regular aerobic, flexibility, and/or muscle-strengthening activities, defined by (1) engaging in 150 mins/week or more of walking, (2) engaging in daily flexibility activity, or (3) engaging 2 or more days/week in muscle-strengthening activities, evaluated at the individual level. Secondary outcomes were changes in specific types of PA and musculoskeletal pain. Outcomes were measured at baseline and at 1 and 3 years (2009, 2010, and 2012). The CWI did not significantly increase the proportion of adults who reached recommended levels of aerobic, flexibility, and/or muscle-strengthening activities (adjusted change difference = 1.6% [95% CI: -3.5, 6.6]). In the subgroup analysis, compared to the controls, adults doing flexibility activity daily significantly increased in Group FM (6.3% [95% CI: 1.9, 10.7]). In Group A and AFM for PA outcomes and in all groups for pain outcomes, there was no significant change compared to controls. The CWI did not achieve significant increase in the proportion of adults who reached recommended PA levels. However, it might be effective in promoting flexibility activity in middle-aged and older Japanese. UMIN-CTR UMIN000002683 .

Modular Approach to Therapy for Anxiety, Depression, Trauma, or Conduct Problems in outpatient child and adolescent mental health services in New Zealand: study protocol for a randomized controlled trial.

PubMed

Lucassen, Mathijs F G; Stasiak, Karolina; Crengle, Sue; Weisz, John R; Frampton, Christopher M A; Bearman, Sarah Kate; Ugueto, Ana M; Herren, Jennifer; Cribb-Su'a, Ainsleigh; Faleafa, Monique; Kingi-'Ulu'ave, Denise; Loy, Jik; Scott, Rebecca M; Hartdegen, Morgyn; Merry, Sally N

2015-10-12

Mental health disorders are common and disabling for young people because of the potential to disrupt key developmental tasks. Implementation of evidence-based psychosocial therapies in New Zealand is limited, owing to the inaccessibility, length, and cost of training in these therapies. Furthermore, most therapies address one problem area at a time, although comorbidity and changing clinical needs commonly occur in practice. A more flexible approach is needed. The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC) is designed to overcome these challenges; it provides a range of treatment modules addressing different problems, within a single training program. A clinical trial of MATCH-ADTC in the USA showed that MATCH-ADTC outperformed usual care and standard evidence-based treatment on several clinical measures. We aim to replicate these findings and evaluate the impact of providing training and supervision in MATCH-ADTC to: (1) improve clinical outcomes for youth attending mental health services; (2) increase the amount of evidence-based therapy content; (3) increase the efficiency of service delivery. This is an assessor-blinded multi-site effectiveness randomized controlled trial. Randomization occurs at two levels: (1) clinicians (≥60) are randomized to intervention or usual care; (2) youth participants (7-14 years old) accepted for treatment in child and adolescent mental health services (with a primary disorder that includes anxiety, depression, trauma-related symptoms, or disruptive behavior) are randomly allocated to receive MATCH-ADTC or usual care. Youth participants are recruited from 'mainstream', Māori-specific, and Pacific-specific child and adolescent mental health services. We originally planned to recruit 400 youth participants, but this has been revised to 200 participants. Centralized computer randomization ensures allocation concealment. The primary outcome measures are: (i) the difference in trajectory of change of clinical severity between groups (using the parent-rated Brief Problem Monitor); (ii) clinicians' use of evidence-based treatment procedures during therapy sessions; (iii) total time spent by clinicians delivering therapy. If MATCH-ADTC demonstrates effectiveness it could offer a practical efficient method to increase access to evidence-based therapies, and improve outcomes for youth attending secondary care services. Australian and New Zealand Clinical Trials Registry ACTRN12614000297628 .

Precision of systematic and random sampling in clustered populations: habitat patches and aggregating organisms.

PubMed

McGarvey, Richard; Burch, Paul; Matthews, Janet M

2016-01-01

Natural populations of plants and animals spatially cluster because (1) suitable habitat is patchy, and (2) within suitable habitat, individuals aggregate further into clusters of higher density. We compare the precision of random and systematic field sampling survey designs under these two processes of species clustering. Second, we evaluate the performance of 13 estimators for the variance of the sample mean from a systematic survey. Replicated simulated surveys, as counts from 100 transects, allocated either randomly or systematically within the study region, were used to estimate population density in six spatial point populations including habitat patches and Matérn circular clustered aggregations of organisms, together and in combination. The standard one-start aligned systematic survey design, a uniform 10 x 10 grid of transects, was much more precise. Variances of the 10 000 replicated systematic survey mean densities were one-third to one-fifth of those from randomly allocated transects, implying transect sample sizes giving equivalent precision by random survey would need to be three to five times larger. Organisms being restricted to patches of habitat was alone sufficient to yield this precision advantage for the systematic design. But this improved precision for systematic sampling in clustered populations is underestimated by standard variance estimators used to compute confidence intervals. True variance for the survey sample mean was computed from the variance of 10 000 simulated survey mean estimates. Testing 10 published and three newly proposed variance estimators, the two variance estimators (v) that corrected for inter-transect correlation (ν₈ and ν(W)) were the most accurate and also the most precise in clustered populations. These greatly outperformed the two "post-stratification" variance estimators (ν₂ and ν₃) that are now more commonly applied in systematic surveys. Similar variance estimator performance rankings were found with a second differently generated set of spatial point populations, ν₈ and ν(W) again being the best performers in the longer-range autocorrelated populations. However, no systematic variance estimators tested were free from bias. On balance, systematic designs bring more narrow confidence intervals in clustered populations, while random designs permit unbiased estimates of (often wider) confidence interval. The search continues for better estimators of sampling variance for the systematic survey mean.

Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function. Methods/Design This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%. The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required. Discussion The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty. Trial registration U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153 PMID:24341348

Quality of reporting of randomized clinical trials in implant dentistry. A systematic review on critical aspects in design, outcome assessment and clinical relevance.

PubMed

Cairo, Francesco; Sanz, Ignacio; Matesanz, Paula; Nieri, Michele; Pagliaro, Umberto

2012-02-01

The aim of this systematic review (SR) was to assess the quality of reporting randomized clinical trials (RCTs) in the field of implant dentistry, its evolution over time and the possible relations between quality items and reported outcomes. RCTs in implant dentistry were retrieved through electronic and hand searches. Risk of bias in individual studies was assessed focusing on study design, outcome assessment and clinical relevance. Associations between quality items and year of publication of RCTs or reporting of statistically significant outcomes were tested. Among the 495 originally screened manuscripts published from 1989 to April 2011, 276 RCTs were assessed in this SR; 59% of them were published between 2006 and 2011. RCTs were mainly parallel (65%), with a single centre (83%) and a superiority design (88%). Trials in implant dentistry showed several methodological flaws: only 37% showed a random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, only 12% performed a correct sample size calculation, the examiner was blind solely in 42% of studies where blinding was feasible. In addition, only 21% of RCTs declared operator experience and 31% reported patient-related outcomes. Many quality items improved over time. Allocation concealment at high risk of bias (p = 0.0125), no information on drop-out (p = 0.0318) and lack of CONSORT adherence (p = 0.0333) were associated with statistically significant reported outcomes. The overall quality of reporting of RCTs in implant dentistry is poor and only partially improved in the last years. Caution is suggested when interpreting these RCTs since risk of bias was associated with higher chance of reporting of statistically significant results. © 2012 John Wiley & Sons A/S.

Effects of massage therapy and occlusal splint therapy on mandibular range of motion in individuals with temporomandibular disorder: a randomized clinical trial.

PubMed

Gomes, Cid André Fidelis de Paula; Politti, Fabiano; Andrade, Daniel Ventura; de Sousa, Dowglas Fernando Magalhães; Herpich, Carolina Marciela; Dibai-Filho, Almir Vieira; Gonzalez, Tabajara de Oliveira; Biasotto-Gonzalez, Daniela Aparecida

2014-01-01

The purpose of this study was to investigate the effects of massage therapy compared with occlusal splint therapy on mandibular range of motion (ROM) in individuals with temporomandibular disorder (TMD) and compare the results with ROM obtained in a group of individuals without this disorder. A blinded randomized clinical trial was conducted. Twenty-eight volunteers with TMD were randomly distributed into either a massage therapy group or an occlusal splint group. Both treatments were provided for 4 weeks. Fourteen individuals without TMD were consecutively allocated to a comparison group. Fonseca anamnestic index was used to characterize TMD and allocate the volunteers to either of the intervention groups or asymptomatic comparison group. Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way repeated-measures analysis of variance with a post hoc Bonferroni testing was used for intergroup and intragroup comparisons (level of significance was set to 5%). Cohen d was used to calculate the effect size. In the intragroup analysis, significant increases in ROM were found for all measures in both the massage and occlusal splint groups (P < .05). A small to moderate clinical effect of treatment with the occlusal splint was found regarding right and left lateral excursion in comparison with the massage therapy and asymptomatic comparison groups (0.2

The effect of green tea extract supplementation on sputum smear conversion and weight changes in pulmonary TB patients: A randomized controlled trial

PubMed Central

Honarvar, Mohammad Reza; Eghtesadi, Shahryar; Gill, Pooria; Jazayeri, Shima; Vakili, Mohammad Ali; Shamsardekani, Mohammad Reza; Abbasi, Abdollah

2016-01-01

Background: Acceleration in sputum smear conversion helps faster improvement and decreased probability of the transfer of TB. In this study, we aimed to investigate the effect of green tea extract supplementation on sputum smear conversion and weight changes in smear positive pulmonary TB patients in Iran. Methods: In this double blind clinical study, TB patients were divided into intervention, (n=43) receiving 500 mg green tea extract (GTE), and control groups (n=40) receiving placebo for two months, using balanced randomization. Random allocation and allocation concealment were observed. Height and weight were measured at the beginning, and two and six months post-treatment. Evaluations were performed on three slides, using the ZiehlNeelsen method. Independent and paired t test, McNemar’s, Wilcoxon, Kaplan-Meier, Cox regression model and Log-Rank test were utilized. Statistical significance was set at p<0.05. This trial was registered under IRCT201212232602N11. Results: The interventional changes and the interactive effect of intervention on weight were not significant (p>0.05). In terms of shortening the duration of conversion, the case to control proportion showed a significant difference (p=0.032). Based on the Cox regression model, the hazard ratio of the relative risk of delay in sputum smear conversion was 3.7 (p=0.002) in the higher microbial load group compared to the placebo group and 0.54 (95% CI: 0.31-0.94) in the intervention compared to the placebo group. Conclusion: GTE decreases the risk of delay in sputum smear conversion, but has no effect on weight gain. Moreover, it may be used as an adjuvant therapy for faster rehabilitation for pulmonary TB patients. PMID:27493925

Comparative Analgesic Efficacy of Oxycodone/Acetaminophen Versus Hydrocodone/Acetaminophen for Short-term Pain Management in Adults Following ED Discharge.

PubMed

Chang, Andrew K; Bijur, Polly E; Holden, Lynne; Gallagher, E John

2015-11-01

The objective was to test the hypothesis that oxycodone/acetaminophen provides superior analgesia to hydrocodone/acetaminophen for the treatment of acute extremity pain following emergency department (ED) discharge. This was a prospective, randomized, double-blind clinical trial of nonelderly adult ED patients with acute musculoskeletal extremity pain, randomly allocated at discharge to receive oxycodone/acetaminophen (5 mg/325 mg) or hydrocodone/acetaminophen (5 mg/325 mg). The primary outcome was the between-group difference in improvement in numerical rating scale (NRS) pain scores over a 2-hour period following the most recent ingestion of study drug, obtained during telephone contact 24 hours after ED discharge. Secondary outcomes included proportionate decrease in pain, comparative side-effect profiles, and patient satisfaction. A total of 240 patients were enrolled. The final sample consisted of 220 patients, 107 randomly allocated to oxycodone/acetaminophen and 113 to hydrocodone/acetaminophen. At 24 hours after ED discharge, the mean NRS pain scores prior to the most recent dose of outpatient pain medication were 7.8 and 7.9 in the oxycodone/acetaminophen and hydrocodone/acetaminophen groups, respectively. The mean decreases in pain scores over 2 hours were 4.4 NRS units in the oxycodone/acetaminophen group versus 4.0 NRS units in the hydrocodone/acetaminophen group, for a difference of 0.4 NRS units (95% confidence interval = -0.2 to 1.1 NRS units). Satisfaction with the analgesics was similar. This study design could not detect a clinically or statistically significant difference in analgesic efficacy between oxycodone/acetaminophen (5 mg/325 mg) and hydrocodone/acetaminophen (5 mg/325 mg) for treatment of acute musculoskeletal extremity pain in adults following ED discharge. Both opioids reduced pain scores by approximately 50%. © 2015 by the Society for Academic Emergency Medicine.

Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial.

PubMed

Raghav, Kumar; Van Wijk, A J; Abdullah, Fawzia; Islam, Md Nurul; Bernatchez, Marc; De Jongh, Ad

2016-02-27

Virtual Reality Exposure Therapy (VRET) is found to be a promising and a viable alternative for in vivo exposure in the treatment of specific phobias. However, its usefulness for treating dental phobia is unexplored. The aims of the present study are to determine: (a) the efficacy of VRET versus informational pamphlet (IP) control group in terms of dental trait and state anxiety reductions at 1 week, 3 months and 6 months follow-up (b) the real-time physiological arousal [heart rate (HR)] of VRET group participants during and following therapy (c) the relation between subjective (presence) and objective (HR) measures during VRET. This study is a single blind, randomized controlled trial with two parallel arms in which participants will be allocated to VRET or IP with a ratio of 1:1. Thirty participants (18-50 years) meeting the Phobia Checklist criteria of dental phobia will undergo block randomization with allocation concealment. The primary outcome measures include participants' dental trait anxiety (Modified Dental Anxiety Scale and Dental Fear Survey) and state anxiety (Visual Analogue Scale) measured at baseline (T0), at intervention (T1), 1-week (T2), 3 months (T3) and 6 months (T4) follow-up. A behavior test will be conducted before and after the intervention. The secondary outcome measures are real-time evaluation of HR and VR (Virtual Reality) experience (presence, realism, nausea) during and following the VRET intervention respectively. The data will be analyzed using intention-to-treat and per-protocol analysis. This study uses novel non-invasive VRET, which may provide a possible alternative treatment for dental anxiety and phobia. ISRCTN25824611 , Date of registration: 26 October 2015.

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial.

PubMed

Zachariae, Robert; Amidi, Ali; Damholdt, Malene F; Clausen, Cecilie D R; Dahlgaard, Jesper; Lord, Holly; Thorndike, Frances P; Ritterband, Lee M

2018-02-20

Insomnia is two to three times more prevalent in cancer survivors than in the general population, where it is estimated to be 10% to 20%. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, but meeting survivor needs remains a challenge. Internet-delivered CBT-I (iCBT-I) has been shown efficacious in otherwise healthy adults. We tested the efficacy of iCBT-I in breast cancer survivors with clinically significant sleep disturbance. Women from a national sample of Danish breast cancer survivors who experienced clinically significant sleep disturbance were randomly allocated to iCBT-I or waitlist control (55:45). The fully automated iCBT-I program consisted of six cores. Online measures of insomnia severity, sleep quality, and fatigue were collected at baseline, postintervention (nine weeks), and follow-up (15 weeks). Online sleep diaries were completed over two-week periods pre- and postintervention. Intention-to-treat analyses (time × group interactions) were conducted with mixed linear models and corrected for multiple outcomes. All statistical tests were two-sided. A total of 255 women were randomly allocated to iCBT-I (n = 133) or waitlist control (n = 122). Statistically significant (P ≤ .02) time × group interactions were found for all sleep-related outcomes from pre- to postintervention. Effect sizes (Cohen's d) ranged from 0.33 (95% confidence interval [CI] = 0.06 to 0.61) for wake after sleep onset to 1.17 (95% CI = 0.87 to 1.47) for insomnia severity. Improvements were maintained for outcomes measured at follow-up (d = 0.66-1.10). iCBT-I appears to be effective in breast cancer survivors, with additional benefit in terms of reduced fatigue. This low-cost treatment could be incorporated in cancer rehabilitation programs.

Agents for facilitation of laryngeal mask airway insertion: a comparative study between thiopentone sodium and propofol.

PubMed

Sengupta, Janmejoy; Sengupta, Mohua; Nag, Tulsi

2014-01-01

Development of endotracheal intubation to avoid deleterious effect on hemodynamic responses occurring during laryngoscopy and intubation compelled researchers to venture into alternative measures of airway management with subtle hemodynamic responses. This study was carried out to compare the conditions for laryngeal mask airways LMA insertion with widely used intravenous induction agents, thiopentone sodium and propofol, and also to compare the undesired responses occurring during LMA insertion with them. The study was prospective, randomized, and double blind. All patients selected were randomly allocated into two groups: Group 1 (propofol) and group II (thiopentone). Preinduction heart rate and blood pressure were recorded. Sixty healthy adult patients of either sex belonging to age group of 20-60 years and ASA grade I or II, to undergo surgery less than 1 h, were selected for the study-Patients were randomly allocated in two groups, 30 in each group. Premedication with midazolam 0.04 mg/kg and fentanyl 2 mg/kg done in both groups. Thereafter, group 1 was induced with 2 mg/kg of propofol and group 2 with 5 mg/kg of thiopentone sodium. The study revealed that, ease of insertion of LMA, was statistically significantly greater in group 1 when compared with group 2 (P 0.05). The time required for successful insertion of LMA was lesser in group 1 patients (53.8 ± 7.77 s) than in group 2 patients (84.7 ± 16.54 s) (P 0.001). Severity of undesired responses were more in group 2, as incremental boluses of respective induction agents were required in 20% patients in thiopentone group compared to only 6% patients in propofol group and 13% of patients in thiopentone group required rescue succinylcholine.

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

PubMed

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

2017-01-01

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

Exercise improves cardiorespiratory fitness in people with depression: A meta-analysis of randomized control trials.

PubMed

Stubbs, Brendon; Rosenbaum, Simon; Vancampfort, Davy; Ward, Philip B; Schuch, Felipe B

2016-01-15

Cardiorespiratory fitness (CRF) is an independent predictor of cardiovascular disease and all-cause mortality. CRF improves in response to exercise interventions, yet the effectiveness of such interventions to improve CRF among people with depression is unclear. We conducted a systematic review and meta-analysis to evaluate whether CRF improves in people with depression in exercise randomized control trials (RCTs). Three authors identified RCTs from a recent Cochrane review and conducted updated searches of major electronic databases. We included RCTs of exercise interventions in people with depression (including major depressive disorder (MDD) and above-threshold depressive symptoms) that reported CRF (defined as predicted maximal oxygen uptake (VO2max predicted) or peak oxygen uptake (VO2peak)) versus a control condition. A random effects meta-analysis was conducted. Seven unique RCTs including 8 aerobic exercise interventions for depression were eligible, including 293 people allocated to exercise (mean age=40.3 years, range=27.2-64.7 years and 35-100% female) and 205 allocated to control conditions. Across all studies exercise results in a significant increase in CRF (g=0.64, 95%CI=0.32-0.96, p<0.001) equating to a mean increase of 3.05 ml/kg/min. Results remained significant when restricted to MDD only (N=5, g=0.41, 95%CI=0.18-0.64, p<0.001) and in high quality studies (N=5, g=0.60, 95%CI=0.19-1.00, p=0.004). People with depression can achieve clinically relevant improvements in CRF in response to exercise interventions. Targeting 'fitness' rather than 'fatness' may be another feasible intervention strategy in this population. Copyright © 2015 Elsevier B.V. All rights reserved.

Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures.

PubMed

2014-06-26

Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

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.

Motivational Interviewing to Treat Overweight Children: 24-Month Follow-Up of a Randomized Controlled Trial.

PubMed

Broccoli, Serena; Davoli, Anna Maria; Bonvicini, Laura; Fabbri, Alessandra; Ferrari, Elena; Montagna, Gino; Panza, Costantino; Pinotti, Mirco; Storani, Simone; Tamelli, Marco; Candela, Silvia; Bellocchio, Eletta; Giorgi Rossi, Paolo

2016-01-01

Pediatrician-led motivational interviewing can be an effective way of controlling BMI in overweight children in the short term. Its long-term efficacy is unknown. The primary aim was to determine whether the short-term (12-month) impact of family pediatrician-led motivational interviews on the BMI of overweight children could be sustained in the long term (24 months), in the absence of any other intervention. Children were recruited in 2011 by family pediatricians working in the province of Reggio Emilia, Italy, and randomly allocated to receive either 5 interviews delivered over a 12-month period or usual care. Eligible participants were all 4- to 7-year-old overweight children resident in the province of Reggio Emilia who had been receiving care from the pediatrician for ≥ 12 months. The primary outcome of this study was individual variation in BMI between the baseline visit and the 24-month follow-up, assessed by pediatricians not blinded to treatment group allocation. Of 419 eligible families, 372 (89%) participated; 187 children were randomized to receive intervention and 185 to usual care. Ninety-five percent of the children attended the 12-month follow-up, and 91% attended the 24-month follow-up. After the 12-month intervention period, BMI in the intervention group increased less than in the control group (0.46 and 0.78, respectively; difference -0.32; P = .005). At the 24-month follow-up, the difference had disappeared (1.52 and 1.56, respectively; difference -0.04; P = .986). The intervention lost its effectiveness within 1 year of cessation. Sustainable boosters are required for weight control and obesity prevention. Copyright © 2016 by the American Academy of Pediatrics.

Augmentation effect of acupuncture on Bi'nao for hypophasis in patients with Bell's palsy: study protocol for a randomized controlled trial.

PubMed

Li, Xiaoyan; Chen, Chunlan; Zhao, Chuang; Li, Zunyuan; Liang, Wei; Liu, Zhidan

2018-06-11

Hypophasis is one of the most frequently observed sequelae of patients with Bell's palsy, who have not recovered completely, creating a clinical difficulty for physicians. Acupuncture therapy has been widely used to treat Bell's palsy as a reasonable resolution for management of symptoms such as hypophasis. The number of acupuncture points (acu-points) is frequently selected in the approach of acupuncture therapy; however, whether these had high efficiency has not been proved. According to the literature review, Bi'nao was useful for treating eye and eye lipid diseases, which could be proved only by some successful cases. Thus, a randomized controlled trial was designed to evaluate the efficiency of the acu-point Bi'nao. Participants with hypophasis as the major symptom are selected among patients with Bell's palsy and randomly allocated into one of the three groups at a 1:1:1 allocation ratio. All participants receive conventional acupuncture therapy; however, those assigned to the real acupuncture group will be given added acupuncture therapy on the acu-point Bi'nao, while those assigned to the sham acupuncture group were given extra acupuncture therapy on the sham Bi'nao as a placebo. The efficacy of the acupuncture therapy on the acu-point Bi'nao for hypophasis will be evaluated by Eye Crack Width Measurement (ECWM) and Eyelid Strength Assessment (ESA) before and after therapy. This is the first study assessing the safety and efficiency of Bi'nao in treating the hypophasis of patients with Bell's palsy that might support the application of this acupuncture therapy. However, evaluating hypophasis is challenging, and, thus, ECWM and ESA were applied to measure the eyelid movement. Chinese Clinical Trials Registry, ChiCTR-INR-17012955 . Registered on 12 October 2017.

The Effects of a Gluten-free Diet Versus a Hypocaloric Diet Among Patients With Fibromyalgia Experiencing Gluten Sensitivity-like Symptoms: A Pilot, Open-Label Randomized Clinical Trial.

PubMed

Slim, Mahmoud; Calandre, Elena P; Garcia-Leiva, Juan M; Rico-Villademoros, Fernando; Molina-Barea, Rocio; Rodriguez-Lopez, Carmen M; Morillas-Arques, Piedad

2017-07-01

Patients with fibromyalgia frequently present with symptoms similar to those experienced by patients with gluten-related disorders, raising the possibility that a subgroup of these patients could be experiencing underlying gluten sensitivity. This study aimed to evaluate the effects of a gluten-free diet (GFD) compared with a hypocaloric diet (HCD) among patients with fibromyalgia. Adult patients diagnosed with fibromyalgia were randomly allocated to receive a GFD or a HCD over a 24-week period. The primary outcome measure was the change in the number of gluten sensitivity symptoms. The following secondary outcomes were evaluated: body mass index, Revised Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Brief Pain Inventory, Beck Depression Inventory-II, State-Trait Anxiety Inventory, Short-Form Health Survey, Patient Global Impression Scale of Severity, Patient Global Impression Scale of Improvement, and adverse events. Seventy-five subjects were randomly allocated to receive either a GFD (n=35) or an HCD (n=40). The least squares mean change in the total number of gluten sensitivity symptoms from baseline did not differ significantly between the GFD and HCD groups (-2.44±0.40 for the GFD; -2.10±0.37 for the HCD; P=0.343). Similarly, the 2 dietary interventions did not differ in any of the remaining measured secondary outcomes. Both dietary interventions were well tolerated. Both dietary interventions were associated with similar beneficial outcomes in reducing gluten sensitivity symptoms and other secondary outcomes. However, despite its specificity, GFD was not superior to HCD in reducing the number of gluten sensitivity symptoms or secondary outcomes.

Low-Dose Daily Intake of Vitamin K(2) (Menaquinone-7) Improves Osteocalcin γ-Carboxylation: A Double-Blind, Randomized Controlled Trials.

PubMed

Inaba, Naoko; Sato, Toshiro; Yamashita, Takatoshi

2015-01-01

Vitamin K is essential for bone health, but the effects of low-dose vitamin K intake in Japanese subjects remain unclear. We investigated the effective minimum daily menaquinone-7 dose for improving osteocalcin γ-carboxylation. Study 1 was a double-blind, randomized controlled dose-finding trial; 60 postmenopausal women aged 50-69 y were allocated to one of four dosage group and consumed 0, 50, 100, or 200 μg menaquinone-7 daily for 4 wk, respectively, with a controlled diet in accordance with recommended daily intakes for 2010 in Japan. Study 2 was a double-blind, randomized placebo-controlled trial based on the results of Study 1; 120 subjects aged 20-69 y were allocated to the placebo or MK-7 group and consumed 0 or 100 μg menaquinone-7 daily for 12 wk, respectively. In both studies, circulating carboxylated osteocalcin and undercarboxylated osteocalcin were measured. The carboxylated osteocalcin/undercarboxylated osteocalcin ratio decreased significantly from baseline in the 0 μg menaquinone-7 group, in which subjects consumed the recommended daily intake of vitamin K with vitamin K1 and menaquinone-4 (Study 1). Menaquinone-7 increased the carboxylated osteocalcin/undercarboxylated osteocalcin ratio dose dependently, and significant effects were observed in both the 100 and 200 μg groups compared with the 0 μg group. Undercarboxylated osteocalcin concentrations decreased significantly, and the carboxylated osteocalcin/undercarboxylated osteocalcin ratio increased significantly in the 100 μg menaquinone-7 group compared with the placebo group (Study 2). Daily menaquinone-7 intake ≥100 μg was suggested to improve osteocalcin γ-carboxylation.

Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial.

PubMed

Mackeen, A Dhanya; Durie, Danielle E; Lin, Monique; Huls, Christopher K; Qureshey, Emma; Paglia, Michael J; Sun, Haiyan; Sciscione, Anthony

2018-01-01

To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes. This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than 2 cm or 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat. We enrolled 201 women: 93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groups: in the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, P<.01) in the Foley group compared with the oxytocin group. There were no differences for other infectious morbidities or any other variable studied. In patients with prelabor rupture of membranes, the use of a transcervical Foley catheter in addition to oxytocin does not shorten the time to delivery compared with oxytocin alone, but may increase the incidence of intraamniotic infection. ClinicalTrials.gov, NCT01973036.

Evaluation of the alignment efficiency of nickel-titanium and copper-nickel-titanium archwires in patients undergoing orthodontic treatment over a 12-week period: A single-center, randomized controlled clinical trial.

PubMed

Aydın, Burcu; Şenışık, Neslihan Ebru; Koşkan, Özgür

2018-05-01

The aim of this trial was to compare the alignment efficiency and intermaxillary arch dimension changes of nickel-titanium (NiTi) or copper-nickel-titanium (CuNiTi) round archwires with increasing diameters applied sequentially to the mandibular arch. The initial alignment phase of fixed orthodontic treatment with NiTi or CuNiTi round archwires was studied in a randomly allocated sample of 66 patients. The NiTi group comprised 26 women, 10 men, and the CuNiTi (27℃) group comprised 20 women, 10 men. The eligibility criteria were as follows: anterior mandibular crowding of minimum 6 mm according to Little's Irregularity Index (LII), treatment requiring no extraction of premolars, 12 to 18 years of age, permanent dentition, skeletal and dental Class I malocclusion. The main outcome measure was the alignment of the mandibular anterior dentition; the secondary outcome measure was the change in mandibular dental arch dimensions during 12 weeks. Simple randomization (allocation ratio 1:1) was used in this single-blind study. LII and mandibular arch dimensions were measured on three-dimensional digital dental models at 2-week intervals. No statistically significant difference was observed between NiTi and CuNiTi according to LII ( p > 0.05). Intercanine and intermolar arch perimeters increased in the CuNiTi group ( p < 0.001). Inter-first premolar width showed a statistically significant interaction in week × diameter × application ( p < 0.05). The effects of NiTi and CuNiTi round archwires were similar in terms of their alignment efficiency. However, the intercanine and intermolar arch perimeters, and the inter-first premolar width changes differed between groups.

Quality of reporting of modern randomized controlled trials in medical oncology: a systematic review.

PubMed

Péron, Julien; Pond, Gregory R; Gan, Hui K; Chen, Eric X; Almufti, Roula; Maillet, Denis; You, Benoit

2012-07-03

The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. A total of 357 RCTs were reviewed. The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. The results show that numerous items remained unreported for many trials. Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.

Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial.

PubMed

Sundstrup, Emil; Jakobsen, Markus D; Andersen, Christoffer H; Jay, Kenneth; Persson, Roger; Aagaard, Per; Andersen, Lars L

2014-01-01

Chronic pain and disability of the arm, shoulder, and hand severely affect labor market participation. Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain. An alternative strategy could be to increase physical capacity of the worker by physical conditioning. To investigate the effect of 2 contrasting interventions, conventional ergonomic training (usual care) versus resistance training, on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work. Examiner-blinded, parallel-group randomized controlled trial with allocation concealment. Slaughterhouses located in Denmark, Europe. Sixty-six adults with chronic pain in the shoulder, elbow/forearm, or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder, arm, and hand muscles for 3 x 10 minutes per week, or ergonomic training and education (usual care control group). Pain intensity (average of shoulder, arm, and hand, scale 0 - 10) was the primary outcome, and disability (Work module of DASH questionnaire) as well as isometric shoulder and wrist muscle strength were secondary outcomes. Pain intensity, disability, and muscle strength improved more following resistance training than usual care (P < 0.001, P = 0.05, P <0.0001, respectively [corrected]). Pain intensity decreased by 1.5 points (95% confidence interval -2.0 to -0.9) following resistance training compared with usual care, corresponding to an effect size of 0.91 (Cohen's d). Blinding of participants is not possible in behavioral interventions. However, at baseline outcome expectations of the 2 interventions were similar. Resistance training at the workplace results in clinical relevant improvements in pain, disability, and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work. NCT01671267.

Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial.

PubMed

Williams, Amanda; Wiggers, John; OʼBrien, Kate M; Wolfenden, Luke; Yoong, Sze Lin; Hodder, Rebecca K; Lee, Hopin; Robson, Emma K; McAuley, James H; Haskins, Robin; Kamper, Steven J; Rissel, Chris; Williams, Christopher M

2018-06-01

We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial, embedded within a cohort multiple randomised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and body mass index ≥27 kg/m and <40 kg/m were randomly allocated, using a central concealed random allocation process, to receive advice and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks, and monthly for 6 months. Data analysis was by intention-to-treat according to a prepublished analysis plan. Between May 13, 2015, and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference = 6.5, 95% confidence interval -8.0 to 21.0; P = 0.38) or any secondary outcome. In the intervention group, 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared with usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

Social network intervention in patients with schizophrenia and marked social withdrawal: a randomized controlled study.

PubMed

Terzian, Emanuela; Tognoni, Gianni; Bracco, Renata; De Ruggieri, Edoardo; Ficociello, Rita Angela; Mezzina, Roberto; Pillo, Giuseppe

2013-11-01

To evaluate the efficacy and feasibility of actions intended to implement or improve patients' social network within the Italian National Health Service community mental health services. We conducted a randomized clinical trial through a network of 47 community mental health services on patients with a diagnosis in the schizophrenia spectrum (F20 in the International Classification of Diseases, 10th Revision), who were young (aged younger than 45 years), and with a poor social network (less than 5 relationships). In addition to routine treatments, for the experimental group, the staff identified possible areas of interest for individual patients and proposed social activities taking place outside the services' resources and with members of the community. The main outcome was an improvement in the patients' social network; secondary end points were clinical outcome, abilities of daily living, and work. One- and 2-year outcomes of 345 and 327, respectively, of the 357 patients randomized were analyzed by intention-to-treat. A social network improvement was observed at year 1 in 25% of the patients allocated to routine treatment and in 39.9% of those allocated to the experimental arm (OR 2.0, 95% CI 1.3 to 3.1; adjusted OR 2.4, 95% CI 1.4 to 3.9). The difference remained statistically significant at year 2. No significant differences emerged for any of the other end points. However, patients with 1 or more other areas of improvement at year 1 and 2 showed a statistically significant social network improvement. The activation of social networks as an activity integrated with standard psychiatric care is practicable, without added economic and organizational costs, and appears to produce an effect persisting well beyond its implementation.

Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial.

PubMed

Ross, Sue; Tang, Selphee; Schulz, Jane; Murphy, Magnus; Goncalves, Jose; Kaye, Stephen; Dederer, Lorel; Robert, Magali

2014-12-22

In 2006, Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence, the Gynecare TVT Secur®. For device licensing, no new evidence of TVT Secur efficacy and safety was needed: rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate retropubic tension-free vaginal tape device. Before adopting TVT Secur into our routine clinical practice, we decided to evaluate it. The objective of our Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, TVT Secur, to the established TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life. The sample size estimate for our trial was 300, but the trial stopped early because of poor recruitment. 74 women participated (40 allocated to TVT Secur, 34 to TVT). At 12 months postoperatively, 27/33(82%) of TVT Secur group were cured, compared with 25/28(89%) of the TVT group (relative risk 0.92, 95% confidence interval 0.75 to 1.13, p=0.49). Most women reported little or no SUI symptoms (35/37(95%) vs 29/30(97%), >0.999). Quality of life improved significantly from baseline for both groups (IIQ-7 mean change -25 for both groups) but did not differ between groups (p=0.880). Our small randomized trial did not find statistically significant differences in outcomes between women allocated to the TVT Secur device versus those allocated to the TVT device for stress urinary incontinence. Despite the discontinuation of TVT Secur in March 2013 for commercial reasons, the importance of our study lies in making evidence available for the many women who had a TVT Secur device implanted and their physicians who may be considering alternative treatments. Our experience illustrates the difficulty of undertaking research on new licensed devices in a rapidly changing surgical specialty, and further highlights the need for research before licensing if surgeons and their patients are to be confident in the effectiveness and safety of new surgical devices. ClinicalTrials.gov NCT00685217, 22 May 2008.

Timing of Radiation Therapy and Chemotherapy After Breast-Conserving Surgery for Node-Positive Breast Cancer: Long-Term Results From International Breast Cancer Study Group Trials VI and VII

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

Karlsson, Per, E-mail: per.karlsson@oncology.gu.se; Cole, Bernard F.; Price, Karen N.

Purpose: To update the previous report from 2 randomized clinical trials, now with a median follow-up of 16 years, to analyze the effect of radiation therapy timing on local failure and disease-free survival. Patients and Methods: From July 1986 to April 1993, International Breast Cancer Study Group trial VI randomly assigned 1475 pre-/perimenopausal women with node-positive breast cancer to receive 3 or 6 cycles of initial chemotherapy (CT). International Breast Cancer Study Group trial VII randomly assigned 1212 postmenopausal women with node-positive breast cancer to receive tamoxifen for 5 years, or tamoxifen for 5 years with 3 early cycles of initial CT. Formore » patients who received breast-conserving surgery (BCS), radiation therapy (RT) was delayed until initial CT was completed; 4 or 7 months after BCS for trial VI and 2 or 4 months for trial VII. We compared RT timing groups among 433 patients on trial VI and 285 patients on trial VII who received BCS plus RT. Endpoints were local failure, regional/distant failure, and disease-free survival (DFS). Results: Among pre-/perimenopausal patients there were no significant differences in disease-related outcomes. The 15-year DFS was 48.2% in the group allocated 3 months initial CT and 44.9% in the group allocated 6 months initial CT (hazard ratio [HR] 1.12; 95% confidence interval [CI] 0.87-1.45). Among postmenopausal patients, the 15-year DFS was 46.1% in the no-initial-CT group and 43.3% in the group allocated 3 months initial CT (HR 1.11; 95% CI 0.82-1.51). Corresponding HRs for local failures were 0.94 (95% CI 0.61-1.46) in trial VI and 1.51 (95% CI 0.77-2.97) in trial VII. For regional/distant failures, the respective HRs were 1.15 (95% CI 0.80-1.63) and 1.08 (95% CI 0.69-1.68). Conclusions: This study confirms that, after more than 15 years of follow-up, it is reasonable to delay radiation therapy until after the completion of standard CT.« less

Sedatives for opiate withdrawal in newborn infants.

PubMed

Osborn, David A; Jeffery, Heather E; Cole, Michael J

2010-10-06

Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. To assess the effectiveness and safety of using a sedative compared to a non-opiate control for NAS due to withdrawal from opiates, and to determine which type of sedative is most effective and safe. This update included searches of the Cochrane Central Register of Controlled Trials (Issue 1, 2010), MEDLINE 1966 to April 2010 and abstracts of conference proceedings. Trials enrolling infants with NAS born to mothers with an opiate dependence with > 80% follow-up and using random or quasi-random allocation to sedative or control. Control could include another sedative or non-pharmacological treatment. Each author assessed study quality and extracted data independently. Seven studies enrolling 385 patients were included. There were substantial methodological concerns for most studies including the use of quasi-random allocation methods and sizeable, largely unexplained differences in reported numbers allocated to each group.One study reported phenobarbitone compared to supportive care alone did not reduce treatment failure or time to regain birthweight, but resulted in a significant reduction in duration of supportive care (MD -162.1 min/day, 95% CI -249.2, -75.1). Comparing phenobarbitone to diazepam, meta-analysis of two studies found phenobarbitone resulted in a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). Comparing phenobarbitone with chlorpromazine, one study reported no significant difference in treatment failure.In infants treated with an opiate, one study reported addition of clonidine resulted in no significant difference in treatment failure, seizures or mortality. In infants treated with an opiate, one study reported addition of phenobarbitone significantly reduced the proportion of time infants had a high abstinence severity score, duration of hospitalisation and maximal daily dose of opiate. Infants with NAS due to opiate withdrawal should receive initial treatment with an opiate. Where a sedative is used, phenobarbitone should be used in preference to diazepam. In infants treated with an opiate, the addition of phenobarbitone or clonidine may reduce withdrawal severity. Further studies are needed to determine the role of sedatives in infants with NAS due to opiate withdrawal and the safety and efficacy of adding phenobarbitone or clonidine in infants treated with an opiate for NAS.

Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial.

PubMed

Veroniki, Areti Angeliki; Straus, Sharon E; Ashoor, Huda; Stewart, Lesley A; Clarke, Mike; Tricco, Andrea C

2016-03-15

Individual patient data (IPD) meta-analysis is considered the "gold standard" for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer's dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors' response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences. This trial is registered in Clinical Trials.gov, ID number NCT02569411 . Date of registration 5 October 2015.

Health-related quality of life in women with newly diagnosed polycystic ovary syndrome randomized between clomifene citrate plus metformin or clomifene citrate plus placebo.

PubMed

Moll, E; van Wely, M; Lambalk, C B; Bossuyt, P M M; van der Veen, F

2012-11-01

What is the health-related quality of life (HRQoL) in women with polycystic ovary syndrome (PCOS) undergoing ovulation induction with clomifene citrate (CC) combined with metformin compared with those using CC combined with placebo? Overall quality of life in women with PCOS treated with CC plus metformin was significantly lower than in women treated with CC plus placebo. There are no data on HRQoL in adult women who receive ovulation induction with the purpose of conceiving. Women with PCOS have higher scores on depression and anxiety scales and lower QoL scores than women without PCOS. This study was a secondary analysis of a multi-centre RCT completed between June 2001 and May 2004. The randomization was stratified per centre, and the centres received blinded, numbered containers with medication. There were172 women available for the HRQoL assessment: 85 were allocated to metformin and 87 were allocated to placebo. The Rotterdam Symptom Checklist (RSCL), a standard self-administered questionnaire, was used to assess physical symptoms, psychological distress, activity levels and overall HRQoL. In the intention to treat analysis, we found differences between the treatment groups with respect to physical symptoms and overall HRQoL. Physical well-being was significantly impaired in women allocated to metformin but not in women allocated to placebo. The increase in physical symptoms in the metformin group was caused by side-effects typical of metformin, and was most pronounced at Week 1 (mean difference 12 [95% confidence interval (CI): 8-16] and still apparent at Week 16 [mean difference 7 (95% CI 2-12]. Overall well-being was significantly impaired in the metformin group compared with the placebo group [mean difference 13 (95% CI 6-20)]. RSCL measurements were available only for three quarters of the participants. Although the number of missing questionnaires and the baseline measurements, were comparable between the treatment groups, some form of selection bias cannot be ruled out. Our finding that metformin was more burdensome than placebo, strengthens the recommendation that CC only and not CC plus metformin should be the drug of choice in this patient population. None of the authors declared a conflict of interest. There was no study funding. ISRCTN55906981.

Energy-efficient downlink resource management in self-organized OFDMA-based two-tier femtocell networks

NASA Astrophysics Data System (ADS)

Shahid, Adnan; Aslam, Saleem; Kim, Hyung Seok; Lee, Kyung-Geun

2015-12-01

Femtocell is a novel technology that is used for escalating indoor coverage as well as the capacity of traditional cellular networks. However, interference is the limiting factor for performance improvement due to co-channel deployment between macrocells and femtocells. The traditional network planning is not feasible because of the random deployment of femtocells. Therefore, self-organization approaches are the key to having successful deployment of femtocells. This study presents the joint resource block (RB) and power allocation task for the two-tier femtocell network in a self-organizing manner, with the concern to minimizing the impact of interference and maximizing the energy efficiency. In this study, we analyze the performance of the system in terms of the energy efficiency, which is composed of both the transmission and circuit power. Most of the previous studies investigate the performance regarding the throughput requirement of the two-tier femtocell network while the energy efficiency aspect is largely ignored. Here, the joint allocation task is modeled as a non-cooperative game which is demonstrated to exhibit pure and unique Nash equilibrium. In order to reduce the complexity of the proposed non-cooperative game, the joint RB and power allocation task is divided into two subproblems: an RB allocation and a particle swarm optimization-based power allocation. The analysis of the proposed game is carried out in terms of not only energy efficiency but also throughput. With practical 3rd Generation Partnership Project (3GPP) Long-Term Evolution (LTE) parameters, the simulation results illustrate the superior performance of the proposed game as compared to the traditional methods. Also, the comparison is carried out with the joint allocation scheme which only considers the throughput as the objective function. The results illustrate that significant performance improvement is achieved in terms of energy efficiency with slight loss in the throughput. The analysis in regard to energy efficiency and throughput of the two-tier femtocell network is carried out in terms of the performance metrics, which include convergence, impact of varying RBs, impact of femtocell density, and the fairness index.

Fundamental resource-allocating model in colleges and universities based on Immune Clone Algorithms

NASA Astrophysics Data System (ADS)

Ye, Mengdie

2017-05-01

In this thesis we will seek the combination of antibodies and antigens converted from the optimal course arrangement and make an analogy with Immune Clone Algorithms. According to the character of the Algorithms, we apply clone, clone gene and clone selection to arrange courses. Clone operator can combine evolutionary search and random search, global search and local search. By cloning and clone mutating candidate solutions, we can find the global optimal solution quickly.

Simulation Of Research And Development Projects

NASA Technical Reports Server (NTRS)

Miles, Ralph F.

1987-01-01

Measures of preference for alternative project plans calculated. Simulation of Research and Development Projects (SIMRAND) program aids in optimal allocation of research and development resources needed to achieve project goals. Models system subsets or project tasks as various network paths to final goal. Each path described in terms of such task variables as cost per hour, cost per unit, and availability of resources. Uncertainty incorporated by treating task variables as probabilistic random variables. Written in Microsoft FORTRAN 77.

The effect of a secondary cognitive task on landing mechanics and jump performance.

PubMed

Dai, Boyi; Cook, Ross F; Meyer, Elizabeth A; Sciascia, Yvonne; Hinshaw, Taylour J; Wang, Chaoyi; Zhu, Qin

2018-06-01

Anterior cruciate ligament (ACL) injuries commonly occur during jump-landing tasks when individuals' attention is simultaneously allocated to other objects and tasks. The purpose of the current study was to investigate the effect of allocation of attention imposed by a secondary cognitive task on landing mechanics and jump performance. Thirty-eight recreational athletes performed a jump-landing task in three conditions: no counting, counting backward by 1 s from a randomly given number, and counting backward by 7 s from a randomly given number. Three-dimensional kinematics and ground reaction forces were collected and analysed. Participants demonstrated decreased knee flexion angles at initial contact (p = 0.001) for the counting by 1 s condition compared with the no counting condition. Participants also showed increased peak posterior and vertical ground reaction forces during the first 100 ms of landing (p ≤ 0.023) and decreased jump height (p < 0.001) for the counting by 1 s and counting by 7 s conditions compared with the no counting condition. Imposition of a simultaneous cognitive challenge resulted in landing mechanics associated with increased ACL loading and decreased jump performance. ACL injury risk screening protocols and injury prevention programmes may incorporate cognitive tasks into jump-landing tasks to better simulate sports environments.

Needling versus liquid nitrogen cryotherapy for the treatment of pedal warts a randomized controlled pilot study.

PubMed

Cunningham, Daniel J; Brimage, Jessica T; Naraghi, Reza N; Bower, Virginia M

2014-07-01

We hypothesized that needling of a pedal wart creates local inflammation and a subsequent cell-mediated immune response (CMIR) against human papillomavirus. The primary objective of this study was to investigate whether needling to induce a CMIR against human papillomavirus is an effective treatment for pedal warts compared with liquid nitrogen cryotherapy. A secondary objective was to investigate whether the CMIR induced by needling is effective against satellite pedal warts. Eligible patients with pedal warts were randomly allocated to receive either needling or liquid nitrogen cryotherapy. Only the primary pedal wart was treated during the study. Follow-up was 12 weeks, with outcome assessments made independently under blinded circumstances. Of 37 patients enrolled in the study, 18 were allocated to receive needling and 19 to receive liquid nitrogen cryotherapy. Regression of the primary pedal wart occurred in 64.7% of the needling group (11 of 17) and in 6.2% of the liquid nitrogen cryotherapy group (1 of 16) (P =  .001). No significant relationship was found between needling of the primary pedal wart and regression of satellite pedal warts (P = .615) or complete pedal wart regression (P = .175). There was no significant difference in pain, satisfaction, or cosmesis between the two groups. The regression rate of the primary pedal wart was significantly higher in the needling group compared with the liquid nitrogen cryotherapy group.

Preliminary investigation into application of problem-based learning in the practical teaching of diagnostics

PubMed Central

Rui, Zeng; Rong-Zheng, Yue; Hong-Yu, Qiu; Jing, Zeng; Xue-Hong, Wan; Chuan, Zuo

2015-01-01

Background Problem-based learning (PBL) is a pedagogical approach based on problems. Specifically, it is a student-centered, problem-oriented teaching method that is conducted through group discussions. The aim of our study is to explore the effects of PBL in diagnostic teaching for Chinese medical students. Methods A prospective, randomized controlled trial was conducted. Eighty junior clinical medical students were randomly divided into two groups. Forty students were allocated to a PBL group and another 40 students were allocated to a control group using the traditional teaching method. Their scores in the practice skills examination, ability to write and analyze medical records, and results on the stage test and behavior observation scale were compared. A questionnaire was administered in the PBL group after class. Results There were no significant differences in scores for writing medical records, content of interviewing, physical examination skills, and stage test between the two groups. However, compared with the control group, the PBL group had significantly higher scores on case analysis, interviewing skills, and behavioral observation scales. Conclusion The questionnaire survey revealed that PBL could improve interest in learning, cultivate an ability to study independently, improve communication and analytical skills, and good team cooperation spirit. However, there were some shortcomings in systematization of imparting knowledge. PBL has an obvious advantage in teaching with regard to diagnostic practice. PMID:25848334

Rigid versus semi-rigid orthotic use following TMC arthroplasty: a randomized controlled trial.

PubMed

Prosser, Rosemary; Hancock, Mark J; Nicholson, Leslie; Merry, Cathy; Thorley, Felicity; Wheen, Douglass

2014-01-01

The trapeziometacarpal (TMC) joint of the human thumb is the second most common joint in the hand affected by osteoarthritis. TMC arthroplasty is a common procedure used to alleviate symptoms. No randomized controlled trials have been published on the efficacy of different post-operative orthotic regimes. Fifty six participants who underwent TMC arthroplasty were allocated to either rigid orthotic or semi-rigid orthotic groups. Both groups started an identical exercise program at two weeks following surgery. Outcome measures were assessed by an assessor blinded to group allocation. The primary outcome was the Patient Rated Wrist and Hand Evaluation (PRWHE) and secondary outcomes included the Michigan Hand Questionnaire (MHQ), thumb palmar abduction, first metacarpophalangeal extension and three point pinch grip. Measures were taken pre-operatively, at six weeks, three months and one year post-operatively. Between-group differences were analyzed with linear regression. Both groups performed equally well. There was no significant between-group difference for PRWHE scores (0.47, CI -11.5 to 12.4), including subscales for pain and function, or for any of the secondary outcomes at one year follow-up. We found no difference in outcomes between using a rigid or semi-rigid orthosis after TMC arthroplasty. Patient comfort, cost and availability may determine choice between orthoses in clinical practice. 1b RCT. Copyright © 2014 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

The effect of micronutrient supplementation on treatment outcome in patients with pulmonary tuberculosis: a randomized controlled trial in Mwanza, Tanzania.

PubMed

Range, Nyagosya; Andersen, Ase B; Magnussen, Pascal; Mugomela, Apolinary; Friis, Henrik

2005-09-01

The aim of the study was to assess the effects of micronutrient supplementation on culture conversion in tuberculosis (TB) patients. The study was a randomized, double-blind placebo-controlled 2 x 2 trial of zinc and multi-micronutrient (MMN) supplementation in pulmonary TB patients in Tanzania. A total of 499 pulmonary TB patients were included in the trial after being confirmed sputum-positive by microscopy or culture. At 8 weeks, 25% were sputum-smear positive but only 11% were culture-positive (P<0.0001). No significant differences were observed in culture conversion rate among those allocated to MMN or placebo (89.5 vs. 86.2%, P=0.29) at 8 weeks, although at week 4 those allocated to MMN had a slightly reduced culture conversion rate (42.8 vs. 52.8%, P=0.058). Zinc had no effects on culture conversion. MMN increased weight gain by 0.78 kg [95% confidence interval (CI): 0.12--1.43] at week 8, while zinc supplementation had no effect. The effects of MMN and zinc did not interact and neither MMN nor zinc interacted with human immunodeficiency virus status, sex and culture-intensity at baseline. Neither zinc nor MMN supplementation had significant effects on culture conversion, but MMN supplementation increased weight gain in TB patients.

The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

PubMed

Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan

2017-05-03

The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

Local rhamnosoft, ceramides and L-isoleucine in atopic eczema: a randomized, placebo controlled trial

PubMed Central

Marseglia, Alessia; Licari, Amelia; Agostinis, Fabio; Barcella, Antonio; Bonamonte, Domenico; Puviani, Mario; Milani, Massimo; Marseglia, GianLuigi

2014-01-01

Background A non-steroidal, anti-inflammatory moisturizing cream containing rhamnosoft, ceramides, and L-isoleucine (ILE) (pro-AMP cream) has been recently developed for the specific treatment of atopic eczema (AE) of the face. In this trial, we evaluated the clinical efficacy and tolerability of pro-AMP cream in the treatment of facial AE in children in comparison with an emollient cream. Methods In a randomized, prospective, assessor-blinded, parallel groups (2:1) controlled trial, 107 children (72 allocated to pro-AMP cream and 35 allocated to control group) with mild-to-moderate chronic AE of the face were enrolled. Treatments were applied twice daily for a 6-week period. Facial Eczema Severity Score (ESS) was evaluated at baseline, week 3, and week 6, by an assessor unaware of treatment allocation. Investigator's Global Assessment (IGA) score was assessed at week 3 and at week 6. Tolerability was evaluated at week 3 and at week 6 using a 4-point score (from 0: low tolerability to 3: very good tolerability). Results At baseline ESS, mean (SD) was 6.1 (2.4) in the pro-AMP cream group and 5.3 (3) in the control group. In the pro-AMP group, in comparison with baseline, ESS was significantly reduced to 2.5 (−59%) after 3 wks and to 1.0 (−84%) at week 6 (p = 0.0001). In the control group, ESS was reduced to 3 (−42%) at week 2 and to 2.6 (−50%) at week 6. At week 6, ESS in pro-AMP cream was significantly lower than the control group (1.0 vs. 2.6; p = 0.001). Both products were well tolerated. Conclusion Pro-AMP cream has shown to be effective in the treatment of mild-to-moderate chronic lesion of AE of the face. Clinical efficacy was greater in comparison with an emollient cream. (Clinical trial Registry: NTR4084). PMID:24750568

Impact of Sustained Use of a Multifaceted Computerized Quality Improvement Intervention for Cardiovascular Disease Management in Australian Primary Health Care.

PubMed

Patel, Bindu; Peiris, David; Usherwood, Tim; Li, Qiang; Harris, Mark; Panaretto, Kathryn; Zwar, Nicholas; Patel, Anushka

2017-10-24

We evaluated a multifaceted, computerized quality improvement intervention for management of cardiovascular disease (CVD) risk in Australian primary health care. After completion of a cluster randomized controlled trial, the intervention was made available to both trial arms. Our objective was to assess intervention outcomes in the post-trial period and any heterogeneity based on original intervention allocation. Data from 41 health services were analyzed. Outcomes were (1) proportion of eligible population with guideline-recommended CVD risk factor measurements; and (2) the proportion at high CVD risk with current prescriptions for guideline-recommended medications. Patient-level analyses were conducted using generalized estimating equations to account for clustering and time effects and tests for heterogeneity were conducted to assess impact of original treatment allocation. Median follow-up for 22 809 patients (mean age, 64.2 years; 42.5% men, 26.5% high CVD risk) was 17.9 months post-trial and 35 months since trial inception. At the end of the post-trial period there was no change in CVD risk factor screening overall when compared with the end of the trial period (64.7% versus 63.5%, P =0.17). For patients at high CVD risk, there were significant improvements in recommended prescriptions at end of the post-trial period when compared with the end of the trial period (65.2% versus 56.0%, P <0.001). There was no heterogeneity of treatment effects on the outcomes based on original randomization allocation. CVD risk screening improvements were not observed in the post-trial period. Conversely, improvements in prescribing continued, suggesting that changes in provider and patient actions may take time when initiating medications. URL: http://www.anzctr.org.au. Unique identifier: 12611000478910. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Controlling collective dynamics in complex minority-game resource-allocation systems

NASA Astrophysics Data System (ADS)

Zhang, Ji-Qiang; Huang, Zi-Gang; Dong, Jia-Qi; Huang, Liang; Lai, Ying-Cheng

2013-05-01

Resource allocation takes place in various kinds of real-world complex systems, such as traffic systems, social services institutions or organizations, or even ecosystems. The fundamental principle underlying complex resource-allocation dynamics is Boolean interactions associated with minority games, as resources are generally limited and agents tend to choose the least used resource based on available information. A common but harmful dynamical behavior in resource-allocation systems is herding, where there are time intervals during which a large majority of the agents compete for a few resources, leaving many other resources unused. Accompanying the herd behavior is thus strong fluctuations with time in the number of resources being used. In this paper, we articulate and establish that an intuitive control strategy, namely pinning control, is effective at harnessing the herding dynamics. In particular, by fixing the choices of resources for a few agents while leaving the majority of the agents free, herding can be eliminated completely. Our investigation is systematic in that we consider random and targeted pinning and a variety of network topologies, and we carry out a comprehensive analysis in the framework of mean-field theory to understand the working of control. The basic philosophy is then that, when a few agents waive their freedom to choose resources by receiving sufficient incentives, the majority of the agents benefit in that they will make fair, efficient, and effective use of the available resources. Our work represents a basic and general framework to address the fundamental issue of fluctuations in complex dynamical systems with significant applications to social, economical, and political systems.

A random walk model for evaluating clinical trials involving serial observations.

PubMed

Hopper, J L; Young, G P

1988-05-01

For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.

Experiences of being a control group: lessons from a UK-based randomized controlled trial of group singing as a health promotion initiative for older people.

PubMed

Skingley, Ann; Bungay, Hilary; Clift, Stephen; Warden, June

2014-12-01

Existing randomized controlled trials within the health field suggest that the concept of randomization is not always well understood and that feelings of disappointment may occur when participants are not placed in their preferred arm. This may affect a study's rigour and ethical integrity if not addressed. We aimed to test whether these issues apply to a healthy volunteer sample within a health promotion trial of singing for older people. Written comments from control group participants at two points during the trial were analysed, together with individual semi-structured interviews with a small sample (n = 11) of this group. We found that motivation to participate in the trial was largely due to the appeal of singing and disappointment resulted from allocation to the control group. Understanding of randomization was generally good and feelings of disappointment lessened over time and with a post-research opportunity to sing. Findings suggest that measures should be put in place to minimize the potential negative impacts of randomized controlled trials in health promotion research. © The Author (2013). Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Does framing the hot hand belief change decision-making behavior in volleyball?

PubMed

Raab, Markus; MacMahon, Clare

2015-06-01

Previous discussions of the hot hand belief, wherein athletes believe that they have a greater chance of scoring after 2 or 3 hits (successes) compared with 2 or 3 misses, have focused on whether this is the case within game statistics. Researchers have argued that the perception of the hot hand in random sequences is a bias of the cognitive system. Yet most have failed to explore the impact of framing on the stability of the belief and the behavior based on it. The authors conducted 2 studies that manipulated the frame of a judgment task. In Study 1, framing was manipulated via instructions in a playmaker allocation paradigm in volleyball. In Study 2, the frame was manipulated by presenting videos for allocation decisions from either the actor or observer perspective. Both manipulations changed the hot hand belief and sequential choices. We found in both studies that the belief in continuation of positive or negative streaks is nonlinear and allocations to the same player after 3 successive hits are reduced. The authors argue that neither the hot hand belief nor hot hand behavior is stable, but rather, both are sensitive to decision frames. The results can inform coaches on the importance of how to provide information to athletes.

Allocating under the influence: Effects of alcohol intoxication and social identification on in-group favoritism.

PubMed

Zhou, Jin; Heim, Derek; Monk, Rebecca; Levy, Andrew; Pollard, Paul

2018-06-01

The "social lubrication" function of alcohol during interpersonal interactions is well documented. However, less is known about the effects of alcohol consumption on group-level behavior. Empirical findings from social psychological literature suggest that individuals tend to favor those who are considered as members of their own social group. Not yet evaluated is how alcohol intoxication interacts with this group-level bias. Therefore, the current study examined experimentally the effects of intoxication on group bias. Ninety-four individuals (M age = 20.18, SD = 2.36, 55 women, 39 men) were randomly assigned to consume an alcoholic (n = 48) or a placebo (n = 46) drink before completing manipulated allocation matrices, a task which measured the distribution of hypothetical monetary awards based on social groups. Results point to an interaction between drink condition and social group identification, whereby identification was significantly associated with in-group favoritism among intoxicated individuals only. Following alcohol consumption, participants with higher identification with their social group were more likely to demonstrate allocation strategies that favored their own group members. However, nonsignificant effects were observed for those in the placebo condition. The findings highlight how alcohol intoxication may facilitate group bias that results from social group identification. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The relationship between prevalence of active trachoma, water availability and its use in a Tanzanian village.

PubMed

Polack, Sarah; Kuper, Hannah; Solomon, Anthony W; Massae, Patrick A; Abuelo, Carolina; Cameron, Ewen; Valdmanis, Vivian; Mahande, Michael; Foster, Allen; Mabey, David

2006-11-01

This study aimed to establish the relationship between the prevalence of active trachoma in children, water availability and household water use in a village in Tanzania. Nine hundred and fourteen children aged 1-9 years were examined for signs of trachoma. Data were collected on time taken to collect water, amount of water collected and other trachoma risk factors. In a sub-study, 99 randomly selected households were visited twice daily on two consecutive days to document patterns of water use. The prevalence of active trachoma in the children examined was 18.4% (95% CI 15.9-20.9). Active trachoma prevalence increased with increasing water collection time (OR 2.25; 95% CI 1.13-4.46) but was unrelated to the amount of water collected. In the sub-study, active trachoma prevalence was substantially lower in children from households where more water was used for personal hygiene (P for trend < or =0.01), independent of the total amount of water used. The allocation of water to hygiene was predicted by lower water collection time. The key element in the relationship between water availability and trachoma is the allocation of water within households. Collection time may influence both the quantity of water collected and its allocation within the household.

Agricultural waste utilisation strategies and demand for urban waste compost: Evidence from smallholder farmers in Ethiopia.

PubMed

Nigussie, Abebe; Kuyper, Thomas W; de Neergaard, Andreas

2015-10-01

The use of agricultural waste for soil amendment is limited in developing countries. Competition between fuel and feed is the major cause for the insufficient application of agricultural waste on cropland. The aims of this study were therefore (i) to investigate variation in agricultural waste allocation between groups of farmers with different livelihood strategies and link this allocation with the nutrient balances of their production systems, (ii) to identify farm characteristics that influence utilisation of agricultural waste for soil amendment, and (iii) to assess demand for urban waste compost. A total of 220 farmers were selected randomly and interviewed using standardised semi-structured questionnaires. Four groups of farmers, namely (i) field crop farmers, (ii) vegetable producers, (iii) ornamental-plant growers, and (iv) farmers practising mixed farming, were identified using categorical principal component and two-step cluster analyses. Field crop farmers produced the largest quantity of agricultural waste, but they allocated 80% of manure to fuel and 85% of crop residues to feed. Only <10% of manure and crop residues were applied on soils. Farmers also sold manure and crop residues, and this generated 5-10% of their annual income. Vegetable and ornamental-plant growers allocated over 40% of manure and crop residues to soil amendment. Hence, nutrient balances were less negative in vegetable production systems. Education, farm size, land tenure and access to extension services were the variables that impeded allocation of agricultural waste to soil amendment. Replacement of fuel and feed through sustainable means is a viable option for soil fertility management. Urban waste compost should also be used as alternative option for soil amendment. Our results showed variation in compost demand between farmers. Education, landownership, experience with compost and access to extension services explained variation in compost demand. We also demonstrated that labour availability should be used to estimate compost demand beside cash. Copyright © 2015 Elsevier Ltd. All rights reserved.

Sedatives for opiate withdrawal in newborn infants.

PubMed

Osborn, D A; Jeffery, H E; Cole, M J

2002-01-01

Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. To assess the effectiveness and safety of using a sedative compared to a non-opiate control for NAS due to withdrawal from opiates, and to determine which type of sedative is most effective and safe. The standard search strategy of the Neonatal Review Group was used. This included searches of the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002) and MEDLINE 1966-2002. Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to sedative or control. Control could include another sedative or non-pharmacological treatment. Each author assessed study quality and extracted data independently. Primary outcomes included treatment failure (failure to achieve symptom control or use of additional drug treatment), seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. Five studies enrolling a total of 285 patients met inclusion criteria (Finnegan 1984, Kahn 1969, Kaltenbach 1986, Khoo 1995, Madden 1977); however, two (Finnegan 1984, Kaltenbach 1986) may be sequential reports that include some identical patients. Methodological concerns included the use of quasi-random rather than random patient allocation methods in three studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in three studies. Phenobarbital compared to supportive care alone has not been shown to reduce treatment failure or time to regain birthweight (one study). However, the duration of supportive care required to be given to infants each day was significantly reduced (MD -162.1 minutes/day, 95% CI -249.2, -75.1). Comparing phenobarbital to diazepam, meta-analysis of two studies found that phenobarbital produced a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). There was no significant difference in duration of treatment or duration of hospital stay. Comparing phenobarbital with chlorpromazine, one study found no significant difference in treatment failure rate. No data for neurodevelopment were available, reported by treatment group as allocated. No trials were eligible that assessed clonidine for NAS. In newborn infants with NAS, there is no evidence that phenobarbital, compared with supportive care alone, reduces treatment failure; however, phenobarbital may reduce the daily duration of supportive care needed. Phenobarbital, compared to diazepam, reduces treatment failure. There is insufficient evidence to support the use of chlorpromazine or clonidine in newborn infants with NAS. Clonidine and chlorpromazine should only be used in the context of a randomised clinical trial. The results of this review, taken in conjunction with the related review, Opiate treatment for opiate withdrawal in newborn infants (Osborn 2002), indicate that treatment with opiates is the preferred initial therapy for NAS. It is hypothesised that this is particularly true for infants whose mothers have used only opiates during pregnancy. If a sedative is used, phenobarbital is preferred to diazepam. The results of an ongoing trial of the addition of phenobarbital to an opiate are awaited.

Toward Large-Graph Comparison Measures to Understand Internet Topology Dynamics

DTIC Science & Technology

2013-09-01

continuously from randomly selected vantage points in these monitors to destination IP addresses . From each IPv4 /24 prefix on the Internet, a destination is...expected to be more similar. This was verified when the esd and vsd measures applied to this dataset gave a low reading 5 An IPv4 address is a 32-bit...integer value. /24 is the prefix of the IPv4 network starting at a given address , having 24 bits allocated for the network prefix. 6 This utility

Image Annotation and Topic Extraction Using Super-Word Latent Dirichlet Allocation

DTIC Science & Technology

2013-09-01

an image can be used to improve automated image annotation performance over existing generalized annotators. Second, image anno - 3 tations can be used...the other variables. The first ratio in the sampling Equation 2.18 uses word frequency by total words, φ̂ (w) j . The second ratio divides word...topics by total words in that document θ̂ (d) j . Both leave out the current assignment of zi and the results are used to randomly choose a new topic

Two Extremely Red Galaxies

NASA Technical Reports Server (NTRS)

Joseph, Robert D.; Hora, Joseph; Stockton, Alan; Hu, Esther; Sanders, David

1997-01-01

This report concerns one of the major observational studies in the ISO Central Programme, the ISO Normal Galaxy Survey. This is a survey of an unbiased sample of spiral and lenticular galaxies selected from the Revised Shapley-Ames Catalog. It is therefore optically-selected, with a brightness limit of blue magnitude = 12, and otherwise randomly chosen. The original sample included 150 galaxies, but this was reduced to 74 when the allocated observing time was expended because the ISO overheads encountered in flight were much larger than predicted.

Positive effects of subliminal stimulation on memory.

PubMed

Chakalis, E; Lowe, G

1992-06-01

To assess the effect of subliminally embedded auditory material on short-term recall, 60 volunteer subjects undertook a face-name-occupation memory test before and after a 15-min. intervention. They were randomly assigned into three groups (a control group and two experimental groups) and allocated to one of the following conditions: (1) no sound, (2) supraliminal presentation of relaxing music, and (3) subliminal presentation of memory-improvement affirmations embedded in relaxing music. After intervention, only the subliminal group significantly improved their performance on recall of names.

Diclofenac vs oxybuprocaine eyedrops for analgesia in paediatric strabismus surgery.

PubMed

Morton, N S; Benham, S W; Lawson, R A; McNicol, L R

1997-01-01

Forty children undergoing strabismus surgery as day patients were randomly allocated to receive oxybuprocaine 0.4% eyedrops or 0.1% diclofenac eyedrops for perioperative analgesia. A non-invasive anaesthetic technique using the reinforced laryngeal mask airway was used. The study demonstrated that both topical analgesics provided good to excellent analgesia and the anaesthetic technique was associated with a relatively low incidence of nausea and vomiting. Complications were limited to two children who were admitted with persistent postoperative nausea and vomiting.

Diclofenac vs oxybuprocaine eyedrops for analgesia in paediatric strabismus surgery.

PubMed

Morton, N; Benham, S; Lawson, R; McNICOL, L

1997-05-01

Forty children undergoing strabismus surgery as day patients were randomly allocated to receive oxybuprocaine 0.4% eyedrops or 0.1% diclofenac eyedrops for perioperative analgesia. A non-invasive anaesthetic technique using the reinforced laryngeal mask airway was used. The study demonstrated that both topical analgesics provided good to excellent analgesia and the anaesthetic technique was associated with a relatively low incidence of nausea and vomiting. Complications were limited to two children who were admitted with persistent postoperative nausea and vomiting. 1997 Blackwell Science Ltd.

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Cash transfer programme, productive activities and labour supply: Evidence from randomized experiment in Kenya

PubMed Central

Asfaw, Solomon; Davis, Benjamin; Dewbre, Josh; Handa, Sudhanshu; Winters, Paul

2015-01-01

This paper reports analysis of the impact of Kenya’s Cash Transfer for Orphans and Vulnerable Children Programme on the household decisions on productive activities using data from a randomized experimental design. Results show that the programme had a positive and significant impact on food consumption coming from home production, accumulation of productive assets, especially on the ownership of small livestock and on formation of nonfarm enterprise, especially for females. The programme has provided more flexibility to families in terms of labour allocation decisions, particularly for those who are geographically isolated. The programme was also found to have reduced child labour, an important objective of the programme. However we find very little impact of the programme on direct indicators of crop production. PMID:25663712

A novel artificial fish swarm algorithm for solving large-scale reliability-redundancy application problem.

PubMed

He, Qiang; Hu, Xiangtao; Ren, Hong; Zhang, Hongqi

2015-11-01

A novel artificial fish swarm algorithm (NAFSA) is proposed for solving large-scale reliability-redundancy allocation problem (RAP). In NAFSA, the social behaviors of fish swarm are classified in three ways: foraging behavior, reproductive behavior, and random behavior. The foraging behavior designs two position-updating strategies. And, the selection and crossover operators are applied to define the reproductive ability of an artificial fish. For the random behavior, which is essentially a mutation strategy, the basic cloud generator is used as the mutation operator. Finally, numerical results of four benchmark problems and a large-scale RAP are reported and compared. NAFSA shows good performance in terms of computational accuracy and computational efficiency for large scale RAP. Copyright © 2015 ISA. Published by Elsevier Ltd. All rights reserved.

Monthly plasmapheresis for systemic lupus erythematosus with diffuse proliferative glomerulonephritis: a pilot study

PubMed Central

Clark, William F.; Lindsay, Robert M.; Cattran, Daniel C.; Chodirker, William B.; Barnes, Colin C.; Linton, Adam L.

1981-01-01

Twelve patients with systemic lupus erythematosus and biopsy-proved diffuse proliferative glomerulonephritis were randomly allocated to a control group (to continue receiving conventional therapy only) or to a plasmapheresis group (to receive conventional therapy along with one 4-I plasma exchange a month). The six patients treated with plasmapheresis had better preservation of renal function, reduced disease activity, fewer admissions to hospital and less need for steroid and immunosuppressive therapy than the six control patients. The patients treated with plasmapheresis also showed evidence of reduced immunologic activity and had no side effects attributable to the plasma exchange. These results suggest that monthly plasma exchange should be assessed in a controlled randomized trial as a possible therapeutic adjunct in patients with systemic lupus erythematosus and diffuse proliferative glomerulonephritis. PMID:7272867

Linear discriminant analysis with misallocation in training samples

NASA Technical Reports Server (NTRS)

Chhikara, R. (Principal Investigator); Mckeon, J.

1982-01-01

Linear discriminant analysis for a two-class case is studied in the presence of misallocation in training samples. A general appraoch to modeling of mislocation is formulated, and the mean vectors and covariance matrices of the mixture distributions are derived. The asymptotic distribution of the discriminant boundary is obtained and the asymptotic first two moments of the two types of error rate given. Certain numerical results for the error rates are presented by considering the random and two non-random misallocation models. It is shown that when the allocation procedure for training samples is objectively formulated, the effect of misallocation on the error rates of the Bayes linear discriminant rule can almost be eliminated. If, however, this is not possible, the use of Fisher rule may be preferred over the Bayes rule.

Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

PubMed

Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

2015-04-01

Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

Randomized, Double-Blinded, Phase 2 Trial of WR 279,396 (Paromomycin and Gentamicin) for Cutaneous Leishmaniasis in Panama

PubMed Central

Sosa, Néstor; Capitán, Zeuz; Nieto, Javier; Nieto, Melissa; Calzada, José; Paz, Hector; Spadafora, Carmenza; Kreishman-Deitrick, Mara; Kopydlowski, Karen; Ullman, Diane; McCarthy, William F.; Ransom, Janet; Berman, Jonathan; Scott, Charles; Grogl, Max

2013-01-01

In this randomized, double-blinded Phase 2 trial, 30 patients with Leishmania panamensis cutaneous leishmaniasis were randomly allocated (1:1) to receive once daily topical treatment with WR 279,396 (15% paromomycin + 0.5% gentamicin) or Paromomycin Alone (15% paromomycin) for 20 days. The index lesion cure rate after 6 months follow-up was 13 of 15 (87%) for WR 279,396 and 9 of 15 (60%) for Paromomycin Alone (P = 0.099). When all treated lesions were included, the final cure rate for WR 279,398-treated patients was again 87%, but the final cure rate for Paromomycin Alone-treated patients was 8 of 15 (53.3%; P = 0.046). Both creams were well tolerated with mild application site reactions being the most frequent adverse event. The increased final cure rate in the WR 279,396 group in this small Phase 2 study suggests that the combination product may provide greater clinical benefit than paromomycin monotherapy against L. panamensis cutaneous leishmaniasis. PMID:23857024

The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial.

PubMed

Bagheri-Nesami, Masoumeh; Shorofi, Seyed Afshin; Zargar, Nahid; Sohrabi, Maryam; Gholipour-Baradari, Afshin; Khalilian, Alireza

2014-02-01

To examine the effects of foot reflexology massage on anxiety in patients following CABG surgery. In this randomized controlled trial, 80 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups after they were matched on age and gender. On the days following surgery, the experimental group received foot reflexology massage on their left foot 20 min a day for 4 days, while the control group was given a gentle foot rub with oil for one minute. Anxiety was measured using the short-form of the Spielberger State-Trait Anxiety Inventory and the Visual Analogue Scale-Anxiety. Both measurement instruments confirmed a significant decrease in anxiety following the foot reflexology massage. The significant decrease in anxiety in the experimental group following the foot reflexology massage supports the use of this complementary therapy technique for the relief of anxiety. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

Improving diabetes care among patients overdue for recommended testing: a randomized controlled trial of automated telephone outreach.

PubMed

Simon, Steven R; Trinacty, Connie Mah; Soumerai, Stephen B; Piette, John D; Meigs, James B; Shi, Ping; Ensroth, Arthur; Ross-Degnan, Dennis

2010-07-01

The study's objective was to assess the effects of automated telephone outreach with speech recognition (ATO-SR) on diabetes-related testing. We identified 1,200 health plan members who were overdue for diabetes-related testing and randomly allocated 600 to ATO-SR and 600 to usual care (no intervention). The intervention included three interactive calls encouraging recommended testing. The primary outcome was retinopathy testing, since this was the health plan's principal goal. Tests for glycemia, hyperlipidemia, and nephropathy were secondary outcomes. In total, 232 participants (39%) verbally responded to the calls. There was no difference between the intervention and the usual care groups in the primary outcome (adjusted hazard ratio 0.93 [95% CI 0.71-1.22]) and no effect of the intervention on any of the secondary outcomes. Fewer than 40% of the patients randomized to ATO-SR interacted verbally with the system. The intervention had no effect on the study's outcomes.

Are glucose levels, glucose variability and autonomic control influenced by inspiratory muscle exercise in patients with type 2 diabetes? Study protocol for a randomized controlled trial.

PubMed

Schein, Aso; Correa, Aps; Casali, Karina Rabello; Schaan, Beatriz D

2016-01-20

Physical exercise reduces glucose levels and glucose variability in patients with type 2 diabetes. Acute inspiratory muscle exercise has been shown to reduce these parameters in a small group of patients with type 2 diabetes, but these results have yet to be confirmed in a well-designed study. The aim of this study is to investigate the effect of acute inspiratory muscle exercise on glucose levels, glucose variability, and cardiovascular autonomic function in patients with type 2 diabetes. This study will use a randomized clinical trial crossover design. A total of 14 subjects will be recruited and randomly allocated to two groups to perform acute inspiratory muscle loading at 2 % of maximal inspiratory pressure (PImax, placebo load) or 60 % of PImax (experimental load). Inspiratory muscle training could be a novel exercise modality to be used to decrease glucose levels and glucose variability. ClinicalTrials.gov NCT02292810 .

Improved Neural Networks with Random Weights for Short-Term Load Forecasting

PubMed Central

Lang, Kun; Zhang, Mingyuan; Yuan, Yongbo

2015-01-01

An effective forecasting model for short-term load plays a significant role in promoting the management efficiency of an electric power system. This paper proposes a new forecasting model based on the improved neural networks with random weights (INNRW). The key is to introduce a weighting technique to the inputs of the model and use a novel neural network to forecast the daily maximum load. Eight factors are selected as the inputs. A mutual information weighting algorithm is then used to allocate different weights to the inputs. The neural networks with random weights and kernels (KNNRW) is applied to approximate the nonlinear function between the selected inputs and the daily maximum load due to the fast learning speed and good generalization performance. In the application of the daily load in Dalian, the result of the proposed INNRW is compared with several previously developed forecasting models. The simulation experiment shows that the proposed model performs the best overall in short-term load forecasting. PMID:26629825

Improved Neural Networks with Random Weights for Short-Term Load Forecasting.

PubMed

Lang, Kun; Zhang, Mingyuan; Yuan, Yongbo

2015-01-01

An effective forecasting model for short-term load plays a significant role in promoting the management efficiency of an electric power system. This paper proposes a new forecasting model based on the improved neural networks with random weights (INNRW). The key is to introduce a weighting technique to the inputs of the model and use a novel neural network to forecast the daily maximum load. Eight factors are selected as the inputs. A mutual information weighting algorithm is then used to allocate different weights to the inputs. The neural networks with random weights and kernels (KNNRW) is applied to approximate the nonlinear function between the selected inputs and the daily maximum load due to the fast learning speed and good generalization performance. In the application of the daily load in Dalian, the result of the proposed INNRW is compared with several previously developed forecasting models. The simulation experiment shows that the proposed model performs the best overall in short-term load forecasting.

Effects of an internet-based cognitive behavioral therapy intervention on improving work engagement and other work-related outcomes: an analysis of secondary outcomes of a randomized controlled trial.

PubMed

Imamura, Kotaro; Kawakami, Norito; Furukawa, Toshi A; Matsuyama, Yutaka; Shimazu, Akihito; Umanodan, Rino; Kawakami, Sonoko; Kasai, Kiyoto

2015-05-01

This study reported a randomized controlled trial of the effectiveness of an Internet-based cognitive behavioral therapy (iCBT) program on work engagement and secondary work-related outcomes. Participants who fulfilled the inclusion criteria were randomly allocated to an intervention or a control group (N = 381 for each). A 6-week, 6-lesson iCBT program using a Manga (Japanese comic) story was provided only to the intervention group. Work engagement was assessed at baseline and at 3- and 6-month follow-ups for both groups. The iCBT program showed a significant intervention effect on work engagement (P = 0.04) with small effect sizes (Cohen's d = 0.16 at 6-month follow-up). The study showed computerized cognitive behavior therapy delivered via the Internet to be effective (with a small effect size) in increasing work engagement in the general working population. UMIN Clinical Trials Registry (UMIN-CTR) UMIN000006210.

Bubble CPAP versus ventilator CPAP in preterm neonates with early onset respiratory distress--a randomized controlled trial.

PubMed

Tagare, Amit; Kadam, Sandeep; Vaidya, Umesh; Pandit, Anand; Patole, Sanjay

2013-04-01

Bubble continuous positive airway pressure (BCPAP) is a low cost nasal CPAP delivery system with potential benefits to developing nations. To compare the efficacy and safety of BCPAP with ventilator-derived CPAP (VCPAP) in preterm neonates with respiratory distress. In a randomized controlled trial, preterm neonates with Silverman-Anderson score ≥ 4 and oxygen requirement >30% within first 6 h of life were randomly allocated to BCPAP or VCPAP. Proportion of neonates with success or failure was compared. In all, 47 of 57 (82.5%) neonates from BCPAP group and 36 of 57 (63.2%) neonates from the VCPAP group completed CPAP successfully (p = 0.03). Neonates who failed CPAP had higher Silverman-Anderson score (p < 0.01), lower arterial to alveolar oxygenation ratio (p < 0.05) and needed surfactant more frequently (p < 0.01). BCPAP has higher success rate than VCPAP for managing preterm neonates with early onset respiratory distress, with comparable safety.

Efficacy of a Social Self-Value Empowerment Intervention to Improve Quality of Life of HIV Infected People Receiving Antiretroviral Treatment in Nepal: A Randomized Controlled Trial.

PubMed

Bhatta, Dharma Nand; Liabsuetrakul, Tippawan

2017-06-01

We developed a comprehensive and culturally applicable empowerment intervention social self-value package with an aim to assess its efficacy in order to improve the quality of life (QoL) of HIV infected people receiving antiretroviral treatment. Participants were randomly allocated to receive either six weekly intervention sessions or standard care. Nonlinear mixed-effects models were performed to compare changes in empowerment scores over time. Between September and November 2014, 1447 individuals were screened, of whom 132 were randomly assigned to either the intervention or control group. The mean scores of empowerment, social support and quality of life increased and stigma scores were reduced in the intervention group at 3- and 6-months. An intervention effect on social support, stigma and QoL was significantly increased by time and group with low and high empowerment. No adverse events were reported. The empowerment intervention was efficacious in improving QoL of HIV infected people.

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.

Flexible attention deployment in threatening contexts: an instructed fear conditioning study.

PubMed

Shechner, Tomer; Pelc, Tatiana; Pine, Daniel S; Fox, Nathan A; Bar-Haim, Yair

2012-10-01

Factors leading humans to shift attention away from danger cues remain poorly understood. Two laboratory experiments reported here show that context interacts with learning experiences to shape attention avoidance of mild danger cues. The first experiment exposed 18 participants to contextual threat of electric shock. Attention allocation to mild danger cues was then assessed with the dot-probe task. Results showed that contextual threat caused subjects to avert attention from danger cues. In the second experiment, 36 participants were conditioned to the same contextual threat used in Experiment 1. These subjects then were randomly assigned to either an experimental group, trained to shift attention toward danger cues, or a placebo group exposed to the same stimuli without the training component. As in Experiment 1, contextual threat again caused attention allocation away from danger in the control group. However, this did not occur in the experimental group. These experiments show that acute contextual threat and learning experiences interact to shape the deployment of attention away from danger cues.

Looking Across and Looking Beyond the Knowledge Frontier: Intellectual Distance, Novelty, and Resource Allocation in Science

PubMed Central

Boudreau, Kevin J.; Guinan, Eva C.; Lakhani, Karim R.; Riedl, Christoph

2016-01-01

Selecting among alternative projects is a core management task in all innovating organizations. In this paper, we focus on the evaluation of frontier scientific research projects. We argue that the “intellectual distance” between the knowledge embodied in research proposals and an evaluator’s own expertise systematically relates to the evaluations given. To estimate relationships, we designed and executed a grant proposal process at a leading research university in which we randomized the assignment of evaluators and proposals to generate 2,130 evaluator–proposal pairs. We find that evaluators systematically give lower scores to research proposals that are closer to their own areas of expertise and to those that are highly novel. The patterns are consistent with biases associated with boundedly rational evaluation of new ideas. The patterns are inconsistent with intellectual distance simply contributing “noise” or being associated with private interests of evaluators. We discuss implications for policy, managerial intervention, and allocation of resources in the ongoing accumulation of scientific knowledge. PMID:27746512

Optimized design and analysis of preclinical intervention studies in vivo

PubMed Central

Laajala, Teemu D.; Jumppanen, Mikael; Huhtaniemi, Riikka; Fey, Vidal; Kaur, Amanpreet; Knuuttila, Matias; Aho, Eija; Oksala, Riikka; Westermarck, Jukka; Mäkelä, Sari; Poutanen, Matti; Aittokallio, Tero

2016-01-01

Recent reports have called into question the reproducibility, validity and translatability of the preclinical animal studies due to limitations in their experimental design and statistical analysis. To this end, we implemented a matching-based modelling approach for optimal intervention group allocation, randomization and power calculations, which takes full account of the complex animal characteristics at baseline prior to interventions. In prostate cancer xenograft studies, the method effectively normalized the confounding baseline variability, and resulted in animal allocations which were supported by RNA-seq profiling of the individual tumours. The matching information increased the statistical power to detect true treatment effects at smaller sample sizes in two castration-resistant prostate cancer models, thereby leading to saving of both animal lives and research costs. The novel modelling approach and its open-source and web-based software implementations enable the researchers to conduct adequately-powered and fully-blinded preclinical intervention studies, with the aim to accelerate the discovery of new therapeutic interventions. PMID:27480578

Optimized design and analysis of preclinical intervention studies in vivo.

PubMed

Laajala, Teemu D; Jumppanen, Mikael; Huhtaniemi, Riikka; Fey, Vidal; Kaur, Amanpreet; Knuuttila, Matias; Aho, Eija; Oksala, Riikka; Westermarck, Jukka; Mäkelä, Sari; Poutanen, Matti; Aittokallio, Tero

2016-08-02

Recent reports have called into question the reproducibility, validity and translatability of the preclinical animal studies due to limitations in their experimental design and statistical analysis. To this end, we implemented a matching-based modelling approach for optimal intervention group allocation, randomization and power calculations, which takes full account of the complex animal characteristics at baseline prior to interventions. In prostate cancer xenograft studies, the method effectively normalized the confounding baseline variability, and resulted in animal allocations which were supported by RNA-seq profiling of the individual tumours. The matching information increased the statistical power to detect true treatment effects at smaller sample sizes in two castration-resistant prostate cancer models, thereby leading to saving of both animal lives and research costs. The novel modelling approach and its open-source and web-based software implementations enable the researchers to conduct adequately-powered and fully-blinded preclinical intervention studies, with the aim to accelerate the discovery of new therapeutic interventions.

Power corrupts co-operation: cognitive and motivational effects in a double EEG paradigm.

PubMed

Kanso, Riam; Hewstone, Miles; Hawkins, Erin; Waszczuk, Monika; Nobre, Anna Christina

2014-02-01

This study investigated the effect of interpersonal power on co-operative performance. We used a paired electro-encephalogram paradigm: pairs of participants performed an attention task, followed by feedback indicating monetary loss or gain on every trial. Participants were randomly allocated to the power-holder, subordinate or neutral group by creating different levels of control over how a joint monetary reward would be allocated. We found that power was associated with reduced behavioural accuracy. Event-related potential analysis showed that power-holders devoted less motivational resources to their targets than did subordinates or neutrals, but did not differ at the level of early conflict detection. Their feedback potential results showed a greater expectation of rewards but reduced subjective magnitude attributed to losses. Subordinates, on the other hand, were asymmetrically sensitive to power-holders' targets. They expected fewer rewards, but attributed greater significance to losses. Our study shows that power corrupts balanced co-operation with subordinates.

Social problem-solving plus psychoeducation for adults with personality disorder: pragmatic randomised controlled trial.

PubMed

Huband, Nick; McMurran, Mary; Evans, Chris; Duggan, Conor

2007-04-01

Social problem-solving therapy may be relevant in the treatment of personality disorder, although assessments of its effectiveness are uncommon. To determine the effectiveness of a problem-solving intervention for adults with personality disorder in the community under conditions resembling routine clinical practice. Participants were randomly allocated to brief psychoeducation plus 16 problem-solving group sessions (n=87) or to waiting-list control (n=89). Primary outcome was comparison of scores on the Social Problem Solving Inventory and the Social Functioning Questionnaire between intervention and control arms at the conclusion of treatment, on average at 24 weeks after randomisation. In intention-to-treat analysis, those allocated to intervention showed significantly better problem-solving skills (P<0.001), higher overall social functioning (P=0.031) and lower anger expression (P=0.039) compared with controls. No significant differences were found on use of services during the intervention period. Problem-solving plus psychoeducation has potential as a preliminary intervention for adults with personality disorder.

Looking Across and Looking Beyond the Knowledge Frontier: Intellectual Distance, Novelty, and Resource Allocation in Science.

PubMed

Boudreau, Kevin J; Guinan, Eva C; Lakhani, Karim R; Riedl, Christoph

2016-10-01

Selecting among alternative projects is a core management task in all innovating organizations. In this paper, we focus on the evaluation of frontier scientific research projects. We argue that the "intellectual distance" between the knowledge embodied in research proposals and an evaluator's own expertise systematically relates to the evaluations given. To estimate relationships, we designed and executed a grant proposal process at a leading research university in which we randomized the assignment of evaluators and proposals to generate 2,130 evaluator-proposal pairs. We find that evaluators systematically give lower scores to research proposals that are closer to their own areas of expertise and to those that are highly novel. The patterns are consistent with biases associated with boundedly rational evaluation of new ideas. The patterns are inconsistent with intellectual distance simply contributing "noise" or being associated with private interests of evaluators. We discuss implications for policy, managerial intervention, and allocation of resources in the ongoing accumulation of scientific knowledge.

Power corrupts co-operation: cognitive and motivational effects in a double EEG paradigm

PubMed Central

Kanso, Riam; Hewstone, Miles; Hawkins, Erin; Waszczuk, Monika; Nobre, Anna Christina

2014-01-01

This study investigated the effect of interpersonal power on co-operative performance. We used a paired electro-encephalogram paradigm: pairs of participants performed an attention task, followed by feedback indicating monetary loss or gain on every trial. Participants were randomly allocated to the power-holder, subordinate or neutral group by creating different levels of control over how a joint monetary reward would be allocated. We found that power was associated with reduced behavioural accuracy. Event-related potential analysis showed that power-holders devoted less motivational resources to their targets than did subordinates or neutrals, but did not differ at the level of early conflict detection. Their feedback potential results showed a greater expectation of rewards but reduced subjective magnitude attributed to losses. Subordinates, on the other hand, were asymmetrically sensitive to power-holders’ targets. They expected fewer rewards, but attributed greater significance to losses. Our study shows that power corrupts balanced co-operation with subordinates. PMID:23160813

Dinoprostone vaginal insert versus intravenous oxytocin to reduce postpartum blood loss following vaginal or cesarean delivery.

PubMed

Ozalp, E; Tanir, H M; Sener, T

2010-01-01

To compare the impact of a dinoprostone vaginal insert and intravenous oxytocin in reducing blood loss of women undergoing vaginal or cesarean delivery. This study was conducted among term singleton pregnancies delivered vaginally or by elective cesarean section. In the vaginally delivered cases, active management of the third stage of labor was conducted. During cesarean delivery, 20 IU of intravenous oxytocin was administered. Women, who either delivered via the vaginal or abdominal route, were then randomly allocated to receive 10 mg vaginal dinoprostone insert for 12 hours (group I, n: 100) or intravenous oxytocin (group II, n: 100), respectively. Mean blood loss and need for additional uterotonics and postpartum hemoglobin and hematocrit levels at 24 and 36 hours after delivery did not differ between the two groups. Women allocated to the dinoprostone vaginal insert arm experienced more nausea and vomiting. Dinoprostone vaginal insert was as effective as intravenous oxytocin in the prevention of postpartum blood loss.

Adaptive sampling of information in perceptual decision-making.

PubMed

Cassey, Thomas C; Evens, David R; Bogacz, Rafal; Marshall, James A R; Ludwig, Casimir J H

2013-01-01

In many perceptual and cognitive decision-making problems, humans sample multiple noisy information sources serially, and integrate the sampled information to make an overall decision. We derive the optimal decision procedure for two-alternative choice tasks in which the different options are sampled one at a time, sources vary in the quality of the information they provide, and the available time is fixed. To maximize accuracy, the optimal observer allocates time to sampling different information sources in proportion to their noise levels. We tested human observers in a corresponding perceptual decision-making task. Observers compared the direction of two random dot motion patterns that were triggered only when fixated. Observers allocated more time to the noisier pattern, in a manner that correlated with their sensory uncertainty about the direction of the patterns. There were several differences between the optimal observer predictions and human behaviour. These differences point to a number of other factors, beyond the quality of the currently available sources of information, that influences the sampling strategy.

Method for position emission mammography image reconstruction

DOEpatents

Smith, Mark Frederick

2004-10-12

An image reconstruction method comprising accepting coincidence datat from either a data file or in real time from a pair of detector heads, culling event data that is outside a desired energy range, optionally saving the desired data for each detector position or for each pair of detector pixels on the two detector heads, and then reconstructing the image either by backprojection image reconstruction or by iterative image reconstruction. In the backprojection image reconstruction mode, rays are traced between centers of lines of response (LOR's), counts are then either allocated by nearest pixel interpolation or allocated by an overlap method and then corrected for geometric effects and attenuation and the data file updated. If the iterative image reconstruction option is selected, one implementation is to compute a grid Siddon retracing, and to perform maximum likelihood expectation maiximization (MLEM) computed by either: a) tracing parallel rays between subpixels on opposite detector heads; or b) tracing rays between randomized endpoint locations on opposite detector heads.

How selection structures species abundance distributions

PubMed Central

Magurran, Anne E.; Henderson, Peter A.

2012-01-01

How do species divide resources to produce the characteristic species abundance distributions seen in nature? One way to resolve this problem is to examine how the biomass (or capacity) of the spatial guilds that combine to produce an abundance distribution is allocated among species. Here we argue that selection on body size varies across guilds occupying spatially distinct habitats. Using an exceptionally well-characterized estuarine fish community, we show that biomass is concentrated in large bodied species in guilds where habitat structure provides protection from predators, but not in those guilds associated with open habitats and where safety in numbers is a mechanism for reducing predation risk. We further demonstrate that while there is temporal turnover in the abundances and identities of species that comprise these guilds, guild rank order is conserved across our 30-year time series. These results demonstrate that ecological communities are not randomly assembled but can be decomposed into guilds where capacity is predictably allocated among species. PMID:22787020

Impact of peer-led quality improvement networks on quality of inpatient mental health care: study protocol for a cluster randomized controlled trial.

PubMed

Aimola, Lina; Jasim, Sarah; Tripathi, Neeraj; Tucker, Sarah; Worrall, Adrian; Quirk, Alan; Crawford, Mike J

2016-09-21

Quality improvement networks are peer-led programmes in which members of the network assess the quality of care colleagues provide according to agreed standards of practice. These networks aim to help members identify areas of service provision that could be improved and share good practice. Despite the widespread use of peer-led quality improvement networks, there is very little information about their impact. We are conducting a cluster randomized controlled trial of a quality improvement network for low-secure mental health wards to examine the impact of membership on the process and outcomes of care over a 12 month period. Standalone low secure units in England and Wales that expressed an interest in joining the quality improvement network were recruited for the study from 2012 to 2014. Thirty-eight units were randomly allocated to either the active intervention (participation in the network n = 18) or a control arm (delayed participation in the network n = 20). Using a 5 % significance level and 90 % power, it was calculated that a sample size of 60 wards was required taking into account a 10 % drop out. A total of 75 wards were assessed at baseline and 8 wards dropped out the study before the data collection at follow up. Researchers masked to the allocation status of the units assessed all study outcomes at baseline and follow-up 12 months later. The primary outcome is the quality of the physical environment and facilities on the wards. The secondary outcomes are: safety of the ward, patient-rated satisfaction with care and mental well-being, staff burnout, training and supervision. Relative to control wards, it is hypothesized that the quality of the physical environment and facilities will be higher on wards in the active arm of the trial 12 months after randomization. To our knowledge, this is the first randomized evaluation of a peer-led quality improvement network that has examined the impact of participation on both patient-level and service-level outcomes. The study has the potential to help shape future efforts to improve the quality of inpatient care. Current Controlled Trials ISRCTN79614916 . Retrospectively registered 28 March 2014].

Evidence-based new service package vs. routine service package for smoking cessation to prevent high risk patients from cardiovascular diseases (CVD): study protocol for randomized controlled trial

PubMed Central

2013-01-01

Background Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries. While several interventions to stop smoking have been proved successful, the question of how to increase their effectiveness and practicality in developing countries remains. In this study, a newly devised evidence-based smoking cessation service package will be compared with the existing service in a randomized controlled trial within the community setting of Thailand. Method/Design This randomized control trial will recruit 440 current smokers at CVD risk because of being diabetic and/or hypertensive. Informed, consented participants will be randomly allocated into the new service-package arm and the routine service arm. The study will take place in the non-communicable disease clinics of the Maetha District Hospital, Lampang, northern Thailand. The new smoking-cessation service-package comprises (1) regular patient motivation and coaching from the same primary care nurse over a 3-month period; (2) monthly application of piCO + smokerlyzer to sustain motivation of smoker’s quitting attempt and provide positive feedback over a 3-month period; (3) assistance by an assigned family member; (4) nicotine replacement chewing gum to relieve withdrawal symptoms. This new service will be compared with the traditional routine service comprising the 5A approach in a 1-year follow-up. Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-randomized arm, where they will be just followed up and monitored. Primary outcome of the study is smoking cessation rate at 1-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air. Secondary outcomes are smoking cessation rate at the 6-month follow-up, blood pressure and heart rate, CVD risk according to the Framingham general cardiovascular risk score, CVD events and deaths at the 12-month follow-up, and the cost-effectiveness of the health service packages. Intention-to-treat analysis will be followed. Factors influencing smoking cessation will be analyzed by the structure equation model. Discussion This multicomponent intervention, accessible at primary healthcare clinics, and focusing on the individual as well as the family and social environment, is unique and expected to work effectively. Trial registration Current Controlled Trials ISRCTN89315117 PMID:24308874

Evidence-based new service package vs. routine service package for smoking cessation to prevent high risk patients from cardiovascular diseases (CVD): study protocol for randomized controlled trial.

PubMed

Aung, Myo Nyein; Yuasa, Motoyuki; Lorga, Thaworn; Moolphate, Saiyud; Fukuda, Hiroshi; Kitajima, Tsutomu; Yokokawa, Hirohide; Minematsu, Kazuo; Tanimura, Susumu; Hiratsuka, Yoshimune; Ono, Koichi; Naunboonruang, Prissana; Thinuan, Payom; Kawai, Sachio; Suya, Yaoyanee; Chumvicharana, Somboon; Marui, Eiji

2013-12-05

Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries. While several interventions to stop smoking have been proved successful, the question of how to increase their effectiveness and practicality in developing countries remains. In this study, a newly devised evidence-based smoking cessation service package will be compared with the existing service in a randomized controlled trial within the community setting of Thailand. This randomized control trial will recruit 440 current smokers at CVD risk because of being diabetic and/or hypertensive. Informed, consented participants will be randomly allocated into the new service-package arm and the routine service arm. The study will take place in the non-communicable disease clinics of the Maetha District Hospital, Lampang, northern Thailand. The new smoking-cessation service-package comprises (1) regular patient motivation and coaching from the same primary care nurse over a 3-month period; (2) monthly application of piCO + smokerlyzer to sustain motivation of smoker's quitting attempt and provide positive feedback over a 3-month period; (3) assistance by an assigned family member; (4) nicotine replacement chewing gum to relieve withdrawal symptoms. This new service will be compared with the traditional routine service comprising the 5A approach in a 1-year follow-up. Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-randomized arm, where they will be just followed up and monitored. Primary outcome of the study is smoking cessation rate at 1-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air. Secondary outcomes are smoking cessation rate at the 6-month follow-up, blood pressure and heart rate, CVD risk according to the Framingham general cardiovascular risk score, CVD events and deaths at the 12-month follow-up, and the cost-effectiveness of the health service packages. Intention-to-treat analysis will be followed. Factors influencing smoking cessation will be analyzed by the structure equation model. This multicomponent intervention, accessible at primary healthcare clinics, and focusing on the individual as well as the family and social environment, is unique and expected to work effectively. Current Controlled Trials ISRCTN89315117.

Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests.

PubMed

Ferrante di Ruffano, Lavinia; Dinnes, Jacqueline; Sitch, Alice J; Hyde, Chris; Deeks, Jonathan J

2017-02-24

There is a growing recognition for the need to expand our evidence base for the clinical effectiveness of diagnostic tests. Many international bodies are calling for diagnostic randomized controlled trials to provide the most rigorous evidence of impact to patient health. Although these so-called test-treatment RCTs are very challenging to undertake due to their methodological complexity, they have not been subjected to a systematic appraisal of their methodological quality. The extent to which these trials may be producing biased results therefore remains unknown. We set out to address this issue by conducting a methodological review of published test-treatment trials to determine how often they implement adequate methods to limit bias and safeguard the validity of results. We ascertained all test-treatment RCTs published 2004-2007, indexed in CENTRAL, including RCTs which randomized patients to diagnostic tests and measured patient outcomes after treatment. Tests used for screening, monitoring or prognosis were excluded. We assessed adequacy of sequence generation, allocation concealment and intention-to-treat, appropriateness of primary analyses, blinding and reporting of power calculations, and extracted study characteristics including the primary outcome. One hundred three trials compared 105 control with 119 experimental interventions, and reported 150 primary outcomes. Randomization and allocation concealment were adequate in 57 and 37% of trials. Blinding was uncommon (patients 5%, clinicians 4%, outcome assessors 21%), as was an adequate intention-to-treat analysis (29%). Overall 101 of 103 trials (98%) were at risk of bias, as judged using standard Cochrane criteria. Test-treatment trials are particularly susceptible to attrition and inadequate primary analyses, lack of blinding and under-powering. These weaknesses pose much greater methodological and practical challenges to conducting reliable RCT evaluations of test-treatment strategies than standard treatment interventions. We suggest a cautious approach that first examines whether a test-treatment intervention can accommodate the methodological safeguards necessary to minimize bias, and highlight that test-treatment RCTs require different methods to ensure reliability than standard treatment trials. Please see the companion paper to this article: http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0286-0 .

Electroacupuncture plus moxibustion therapy for patients with major depressive disorder: study protocol for a randomized controlled trial.

PubMed

Kim, Mikyung; Choi, Eun-Ji; Kim, Sung-Phil; Kim, Jung-Eun; Park, Hyo-Ju; Kim, Ae-Ran; Seo, Bok-Nam; Kwon, O-Jin; Cho, Jung Hyo; Chung, Sun-Yong; Kim, Joo-Hee

2017-01-13

Major depressive disorder (MDD) is one of the most prevalent mental health disorders and has a significant societal economic burden. Antidepressants and cognitive behavioral therapy are two primary interventions for the standardized treatment of MDD. However, their weaknesses, such as a low response rate, a high risk of adverse events from medication, and the high cost of cognitive behavioral therapy, have resulted in a need for complementary and alternative medicine (CAM). Among the various therapeutic interventions in CAM, electroacupuncture and moxibustion have been widely used to treat various mental illnesses, including MDD. The aim of this study is to evaluate the feasibility of conducting a full-scale randomized controlled trial to investigate the efficacy and safety of electroacupuncture plus moxibustion therapy for MDD. We will include patients between the ages of 19 to 65 years with MDD. A total of 30 participants will be recruited, and they will be randomly allocated into two groups at a 1:1 ratio. Patients in the treatment and control groups will, respectively, receive real and sham electroacupuncture/moxibustion treatments, for a total of 20 sessions over 8 weeks. The primary outcome will be the Hamilton Rating Scale for Depression, and the secondary outcomes will be Beck's Depression Inventory, the Insomnia Severity Index, the State-Trait Anxiety Inventory, the EuroQol 5-Dimension Index, the Measure Yourself Medical Outcome Profile version 2, and electroencephalography. Adverse events will be monitored at each visit to assess safety. All outcomes will be assessed and analyzed by researchers blinded to the treatment allocation. This is a two-armed, parallel-design, patient-assessor blinded, multicenter, randomized, sham-controlled pilot clinical trial. Data will be analyzed before and after treatment and during a 4-week follow-up. The results of the trial will provide a basis for further studies assessing the efficacy and safety of electroacupuncture plus moxibustion treatment for MDD. Korean Clinical Trial Registry, CRIS-KCT0001810 . Registered on 5 February 2016 (retrospectively registered; date of enrollment of the first participant to the trial: 2 December 2015).

Effectiveness of a multimodal standard nursing program on health-related quality of life in Chinese mainland female patients with breast cancer: protocol for a single-blind cluster randomized controlled trial.

PubMed

Zhou, Kaina; Wang, Duolao; He, Xiaole; Huo, Lanting; An, Jinghua; Li, Minjie; Wang, Wen; Li, Xiaomei

2016-08-31

Breast cancer and its treatment-related adverse effects are harmful to physical, psychological, and social functioning, leading to health-related quality of life (HRQoL) impairment in patients. Many programs have been used with this population for HRQoL improvement; however, few studies have considered the physical, psychological, and social health domains comprehensively, and few have constructed multimodal standard nursing interventions based on specific theories. The purpose of this trial is to examine the effect of a health belief model (HBM)-based multimodal standard nursing program (MSNP) on HRQoL in female patients with breast cancer. This is a two-arm single-blind cluster randomized controlled trial (cRCT) in clinical settings. Twelve tertiary hospitals will be randomly selected from the 24 tertiary hospitals in Xi'an, China, and allocated to the intervention arm and control arm using a computer-generated random numbers table. Inpatient female patients with breast cancer from each hospital will receive either MSNP plus routine nursing care immediately after recruitment (intervention arm), or only routine nursing care (control arm). The intervention will be conducted by trained nurses for 12 months. All recruited female patients with breast cancer, participating clinical staff, and trained data collectors from the 12 hospitals will be blind with respect to group allocation. Patients of the control arm will not be offered any information about the MSNP during the study period to prevent bias. The primary outcome is HRQoL measured through the Functional Assessment of Cancer Therapy-Breast version 4.0 at 12 months. Secondary outcomes include pain, fatigue, sleep, breast cancer-related lymphedema, and upper limb function, which are evaluated by a visual analogue scale, the circumference method, and the Constant-Murley Score. This trial will provide important evidence on the effectiveness of multimodal nursing interventions delivered by nurses in clinical settings. Study findings will inform strategies for scaling up comprehensive standard intervention programs on health management in the population of female patients with breast cancer. Chictr.org.cn ChiCTR-IOR-16008253 (April 9, 2016).

Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol.

PubMed

DePaul, Vincent G; Wishart, Laurie R; Richardson, Julie; Lee, Timothy D; Thabane, Lehana

2011-10-21

Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP), a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT) in community-dwelling, ambulatory, adults within 1 year of stroke. A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1) using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used. In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that outcomes will be optimized through the application of a task-related training program that is consistent with key motor learning principles related to practice, guidance and feedback. ClinicalTrials.gov # NCT00561405.

Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol

PubMed Central

2011-01-01

Background Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP), a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT) in community-dwelling, ambulatory, adults within 1 year of stroke. Methods/Design A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1) using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used. Discussion In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that outcomes will be optimized through the application of a task-related training program that is consistent with key motor learning principles related to practice, guidance and feedback. Trial Registration ClinicalTrials.gov # NCT00561405 PMID:22018267

Improving the application of a practice guideline for the assessment and treatment of suicidal behavior by training the full staff of psychiatric departments via an e-learning supported Train-the-Trainer program: study protocol for a randomized controlled trial.

PubMed

de Beurs, Derek P; de Groot, Marieke H; de Keijser, Jos; Verwey, Bastiaan; Mokkenstorm, Jan; Twisk, Jos W R; van Duijn, Erik; van Hemert, Albert M; Verlinde, Lia; Spijker, Jan; van Luijn, Bert; Vink, Jan; Kerkhof, Ad J F M

2013-01-09

In 2012, in The Netherlands a multidisciplinary practice guideline for the assessment and treatment of suicidal behavior was issued. The release of guidelines often fails to change professional behavior due to multiple barriers. Structured implementation may improve adherence to guidelines. This article describes the design of a study measuring the effect of an e-learning supported Train-the-Trainer program aiming at the training of the full staff of departments in the application of the guideline. We hypothesize that both professionals and departments will benefit from the program. In a multicenter cluster randomized controlled trial, 43 psychiatric departments spread over 10 regional mental health institutions throughout The Netherlands will be clustered in pairs with respect to the most prevalent diagnostic category of patients and average duration of treatment. Pair members are randomly allocated to either the experimental or the control condition. In the experimental condition, the full staff of departments, that is, all registered nurses, psychologists, physicians and psychiatrists (n = 532, 21 departments) will be trained in the application of the guideline, in a one-day small interactive group Train-the-Trainer program. The program is supported by a 60-minute e-learning module with video vignettes of suicidal patients and additional instruction. In the control condition (22 departments, 404 professionals), the guideline shall be disseminated in the traditional way: through manuals, books, conferences, internet, reviews and so on. The effectiveness of the program will be assessed at the level of both health care professionals and departments. We aim to demonstrate the effect of training of the full staff of departments with an e-learning supported Train-the-Trainer program in the application of a new clinical guideline. Strengths of the study are the natural setting, the training of full staff, the random allocation to the conditions, the large scale of the study and the willingness of both staff and management to participate in the study. Dutch trial register: NTR3092.

Improving the application of a practice guideline for the assessment and treatment of suicidal behavior by training the full staff of psychiatric departments via an e-learning supported Train-the-Trainer program: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background In 2012, in The Netherlands a multidisciplinary practice guideline for the assessment and treatment of suicidal behavior was issued. The release of guidelines often fails to change professional behavior due to multiple barriers. Structured implementation may improve adherence to guidelines. This article describes the design of a study measuring the effect of an e-learning supported Train-the-Trainer program aiming at the training of the full staff of departments in the application of the guideline. We hypothesize that both professionals and departments will benefit from the program. Method In a multicenter cluster randomized controlled trial, 43 psychiatric departments spread over 10 regional mental health institutions throughout The Netherlands will be clustered in pairs with respect to the most prevalent diagnostic category of patients and average duration of treatment. Pair members are randomly allocated to either the experimental or the control condition. In the experimental condition, the full staff of departments, that is, all registered nurses, psychologists, physicians and psychiatrists (n = 532, 21 departments) will be trained in the application of the guideline, in a one-day small interactive group Train-the-Trainer program. The program is supported by a 60-minute e-learning module with video vignettes of suicidal patients and additional instruction. In the control condition (22 departments, 404 professionals), the guideline shall be disseminated in the traditional way: through manuals, books, conferences, internet, reviews and so on. The effectiveness of the program will be assessed at the level of both health care professionals and departments. Discussion We aim to demonstrate the effect of training of the full staff of departments with an e-learning supported Train-the-Trainer program in the application of a new clinical guideline. Strengths of the study are the natural setting, the training of full staff, the random allocation to the conditions, the large scale of the study and the willingness of both staff and management to participate in the study. Trial registration Dutch trial register: NTR3092 PMID:23302322

Weight management program for treatment-emergent weight gain in olanzapine-treated patients with schizophrenia or schizoaffective disorder: A 12-week randomized controlled clinical trial.

PubMed

Kwon, Jun Soo; Choi, Jung-Seok; Bahk, Won-Myoung; Yoon Kim, Chang; Hyung Kim, Chan; Chul Shin, Young; Park, Byung-Joo; Geun Oh, Chang

2006-04-01

The main objective was to assess the efficacy of a weight management program designed for outpatients taking olanzapine for schizophrenia or schizoaffective disorder and to compare these patients with a randomized control group. The effects of the weight management program were also assessed with regard to safety and quality of life. Forty-eight patients were enrolled in a 12-week, randomized, multicenter weight management study. Thirty-three patients were randomly allocated to an intervention group in which they received olanzapine within a weight management program. Fifteen patients were allocated to a control group in which they were given olanzapine treatment as usual outpatients. Weight, body mass index (BMI), and measurements of safety and quality of life were evaluated. The study was conducted from January 7, 2003, to September 16, 2003. Thirty-six patients (75%) completed this study. We found significant differences in weight (-3.94 +/- 3.63 kg vs. -1.48 +/- 1.88 kg, p = .006) and BMI (-1.50 +/- 1.34 vs. -0.59 +/- 0.73, p = .007) change from baseline to endpoint between the intervention and control groups, respectively. Significant differences in weight reduction were initially observed at week 8 (p = .040). No significant differences were found with regard to the safety outcomes. When the ratio of low-density lipoproteins to high-density lipoproteins was calculated, change from baseline was greater in the intervention group than the control group (-0.19 vs. -0.04), but the difference was not statistically significant (p = .556). After the completion of the weight management program, there was a trend toward statistical difference in the physical health score changes between the weight management and control groups (1.12 in the intervention group vs. -0.93 in the control group, p = .067). The weight management program was effective in terms of weight reduction in patients with schizophrenia or schizoaffective disorder taking olanzapine and was also found to be safe in terms of psychiatric symptoms, vital signs, and laboratory data. In addition, such a weight management program might improve quality of life in patients with schizophrenia or schizoaffective disorder with respect to their physical well-being.

Positive end-expiratory pressure during resuscitation at birth in very-low birth weight infants: A randomized-controlled pilot trial.

PubMed

Kitsommart, Ratchada; Nakornchai, Kittaya; Yangthara, Buranee; Jiraprasertwong, Ratchada; Paes, Bosco

2017-12-09

There is limited evidence of the effect of positive end-expiratory pressure (PEEP) during resuscitation soon after birth. Premature neonates may experience respiratory distress from surfactant insufficiency and providing PEEP after the very first breath, may improve outcomes following appropriate resuscitation. The objective of this study was to evaluate the short term respiratory outcomes after positive pressure ventilation (PPV) with PEEP in preterm infants at birth. A prospective randomized-controlled, pilot trial was conducted. Premature neonates ≤ 32 weeks gestational age or birth weight < 1500 g were recruited. Subjects were allocated to either PEEP of 5 cm H 2 O (PEEP-5) or no PEEP (PEEP-0) if PPV was administered. Pre-ductal, peripheral capillary oxygen saturation (SpO 2 ) and fraction of inspired oxygen concentration (FiO 2 ) were monitored at 1, 3, 5, 10, 15, and 20 min after birth. FiO 2 was adjusted to achieve targeted SpO 2 using the 2010 neonatal resuscitation protocol guidelines. 56% (14/25; PEEP-0) and 50% (13/26; PEEP-5) infants received PPV. Mean gestational age was 30 (PEEP-0) vs 31 (PEEP-5) weeks. The mean [SD] birthweight (g) of PEEP-0 was significantly lower than PEEP-5 (1050.4 [262.7] vs 1218.8 [236.8], p = 0.02). Pre-ductal SpO 2, FiO 2 delivered at each time point, and rates of pneumothorax, surfactant administration and oxygen dependency at 36 weeks postmenstrual age or death was similar. Due to the small sample size and potential bias accrued through random allocation of higher birthweight infants to the PEEP-5 group, the results did not confirm differences in outcomes between the groups, despite evidence favoring postnatal ventilation with PEEP. A further randomized, controlled clinical trial with a larger sample size is warranted to determine the utility and safety of PEEP during the resuscitation of premature infants immediately after birth. Copyright © 2017. Published by Elsevier B.V.

A Prospective Randomized Clinical Trial of a Novel, Noninvasive Perfusion Enhancement System for the Prevention of Hospital-Acquired Sacral Pressure Injuries.

PubMed

Bharucha, Jitendra B; Seaman, Linda; Powers, Michele; Kelly, Erica; Seaman, Rodney; Forcier, Lea; McGinnis, Janice; Nodiff, Isabel; Pawlak, Brooke; Snyder, Samantha; Nodiff, Susan; Patel, Rohan; Squitieri, Rafael; Wang, Lansheng

2018-06-08

The purpose of this study was to determine the effectiveness of a novel, noninvasive perfusion enhancement system versus beds with integrated alternating pressure capabilities for the prevention of hospital-acquired sacral region (sacral, coccygeal, and ischium) pressure injuries in a high-risk, acute care patient population. A prospective randomized trial of high-risk inpatients without preexisting sacral region pressure injuries was conducted. The sample comprised 431 randomly enrolled adult patients in a 300-bed tertiary care community teaching hospital. Subjects were randomly allocated to one of 2 groups: control and experimental. Both groups received "standard-of-care" pressure injury prevention measures per hospital policy, and both were placed on alternating pressure beds during their hospital stays. In addition, patients in the experimental group used a noninvasive perfusion enhancement system placed on top of their alternating pressure beds and recovery chairs throughout their hospital stay. Fischer's exact probability test was used to compare group differences, and odds ratio (OR) were calculated for comparing pressure injury rates in the experimental and control groups. Three hundred ninety-nine patients completed the trial; 186 patients were allocated to the experimental group and 213 patients to the control group. Eleven patients in the control group versus 2 in the experimental group developed hospital-acquired sacral region pressure injuries (51.6% vs 1.07%; P = .024). Control patients were 5.04 times more likely to develop hospital-acquired sacral region pressure injuries (OR = 0.1996; 95% CI, 0.0437-0.9125). Patients using a noninvasive perfusion enhancement system developed significantly fewer hospital-acquired sacral pressure injuries than those using an alternating pressure bed without the perfusion enhancement system. These findings suggest that a perfusion enhancement system enhances the success of use of pressure redistributing beds for prevention of hospital-acquired sacral pressure injuries.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

PubMed

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be laid down on the quality of trials being conducted in order to provide justice in the name of EBP. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of a Skin Barrier Cream on Management of Incontinence-Associated Dermatitis in Older Women: A Cluster Randomized Controlled Trial.

PubMed

Kon, Yuka; Ichikawa-Shigeta, Yoshie; Iuchi, Terumi; Nakajima, Yukari; Nakagami, Gojiro; Tabata, Keiko; Sanada, Hiromi; Sugama, Junko

The purpose of this study was to examine the effects of a skin barrier cream with moisturization and skin-protectant characteristics for improving the severity of incontinence-associated dermatitis (IAD) pertaining to the skin physiology and appearance. We measured the following outcomes: (1) skin physiological characteristics indicating skin protection and enhancement of the skin's moisture barrier (stratum corneum hydration, dermis hydration level, transepidermal water loss, and skin pH); and (2) changes in skin appearance (the degree of erythema and pigmentation, and the sulcus cutis condition). Single-blind, cluster randomized controlled trial. The study was conducted in a long-term care facility in Japan between November 7, 2011, and May 6, 2012. We used block randomization to obtain a random sample of 6 (4 experimental and 2 control) out of 10 available wards. All subjects were elderly women with IAD of the buttock or inner thigh. We assessed 295 patients, but only 33 met inclusion criteria; 18 were allocated to the experimental group and 15 were allocated to the control group. All participants were managed with cleansing with a skin cleanser and application of a moisturizer daily. In addition, a skin barrier cream designed to enhance the skin's moisture barrier and act as a protective barrier was applied to the skin of patients in the experimental group 3 times a day when absorptive briefs were changed. Skin physiological and appearance characteristics were scored only at the buttock or thigh area. All data were collected on days 1 and 14 of the study. Univariate analysis found that the erythema index was lower in the intervention group than in the control group at day 14 (P = .004). Multivariate analysis found significant associations between use of the skin barrier cream and increased stratum corneum hydration (β= .443, P = .031), decreased skin pH (β=-.439, P = .020), and magnitude of erythema (β=-.451, P = .018). Study findings suggest that a barrier cream designed to enhance the skin's moisture barrier and act as a skin protectant increased stratum corneum hydration, reduced cutaneous pH, and reduced erythema.

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial.

PubMed

Pai, Menaka; Lloyd, Nancy S; Cheng, Ji; Thabane, Lehana; Spencer, Frederick A; Cook, Deborah J; Haynes, R Brian; Schünemann, Holger J; Douketis, James D

2013-01-02

Venous thromboembolism (VTE) is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. We conducted a 16-week pilot cluster randomized controlled trial (RCT) to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines) within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians' orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters) in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place). Blinding was not used. A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group) were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022), and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE prophylaxis strategy, including local champions, support from clinical and administrative leaders, mandatory use, and a simple, clinically relevant risk assessment tool. Hospitals allocated to our multicomponent intervention did not have a higher rate of medical inpatients appropriately managed for thromboprophylaxis than did hospitals that were not allocated to this strategy.

Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer's disease: study protocol of a randomized controlled trial (The FIT-AD trial).

PubMed

Yu, Fang; Bronas, Ulf G; Konety, Suma; Nelson, Nathaniel W; Dysken, Maurice; Jack, Clifford; Wyman, Jean F; Vock, David; Smith, Glenn

2014-10-11

Alzheimer's disease, a global public health issue, accounts for 60 to 80% of all dementias. Alzheimer's disease primarily causes cognitive impairment and drugs have only modest short-term effects, highlighting a pressing need to develop effective interventions. Aerobic exercise holds promise for treating cognitive impairment in Alzheimer's disease through biologically sound mechanisms. Nonetheless, aerobic exercise studies in Alzheimer's disease are limited with mixed findings. This pilot randomized controlled trial will investigate the effects of a 6-month, individualized, moderate-intensity cycling intervention (20 to 50 minutes per session, 3 times a week) on cognition and hippocampal volume in community-dwelling older adults with mild-to-moderate Alzheimer's disease. The specific aims are to: 1) determine the immediate effect of the cycling intervention on cognition in Alzheimer's disease; 2) examine if the cycling intervention slows cognitive decline in Alzheimer's disease from baseline to 12 months; and 3) assess the effect of aerobic exercise on hippocampal volume over 12 months. Ninety subjects will be randomized on a 2:1 allocation ratio to cycling or attention control (low-intensity stretching) and followed for another 6 months. Allocations will be concealed to all investigators and outcome assessors will be blinded to group assignments and previous data. Cognition will be measured by the Alzheimer's disease Assessment Scale-Cognition at baseline before randomization and at 3, 6, 9, and 12 months. Hippocampal volume will be measured by magnetic resonance imaging at baseline and 6 and 12 months. The sample size of 90 will give 80% power to detect a 2.5-point difference in within-group changes in the Alzheimer's disease Assessment Scale-Cognition at 6 months for the cycling group. Findings from this study will address the critical gap of exercise efficacy in Alzheimer's disease and use of magnetic resonance imaging as an outcome measure in clinical trials. This study will provide a potential treatment that may increase physical function and quality of life and curb the prohibitive costs for the growing dementia population. Primary registration: (NCT01954550; date of registration: 20 September 2013). Secondary registration: (NCT01954550; date of registration: 1 October 2013).

Acute effects of whole-body vibration on the motor function of patients with stroke: a randomized clinical trial.

PubMed

Silva, Adriana Teresa; Dias, Miqueline Pivoto Faria; Calixto, Ruanito; Carone, Antonio Luis; Martinez, Beatriz Bertolaccini; Silva, Andreia Maria; Honorato, Donizeti Cesar

2014-04-01

The aim of this study was to investigate the acute effects of whole-body vibration on the motor function of patients with stroke. The present investigation was a randomized clinical trial studying 43 individuals with hemiparesis after stroke, with 33 subjects allocated to the intervention group and 10 subjects allocated to the control group. The intervention group was subjected to one session of vibration therapy (frequency of 50 Hz and amplitude of 2 mm) comprising four 1-min series with 1-min rest intervals between series in three body positions: bipedal stances with the knees flexed to 30 degrees and 90 degrees and a unipedal stance on the paretic limb. The analytical tests were as follows: simultaneous electromyography of the affected and unaffected tibialis anterior and rectus femoris muscles bilaterally in voluntary isometric contraction; the Six-Minute Walk Test; the Stair-Climb Test; and the Timed Get-Up-and-Go Test. The data were analyzed by independent and paired t tests and by analysis of covariance. There was no evidence of effects on the group and time interaction relative to variables affected side rectus femoris, unaffected side rectus femoris, affected side tibialis anterior, unaffected side tibialis anterior, and the Stair-Climb Test (P > 0.05). There was evidence of effects on the group interaction relative to variables Six-Minute Walk Test and Timed Get-Up-and-Go Test (P < 0.05). Whole-body vibration contributed little to improve the functional levels of stroke patients.

Intravenous rocuronium 0.3 mg/kg improves the conditions for tracheal intubation in cats: a randomized, placebo-controlled trial.

PubMed

Sakai, Daniel M; Zornow, Kailee Anne; Campoy, Luis; Cable, Christina; Appel, Leslie D; Putnam, Holly J; Martin-Flores, Manuel

2018-01-01

Objectives We evaluated the use of rocuronium 0.3 mg/kg intravenously (IV) to facilitate tracheal intubation in cats anesthetized for elective ovariohysterectomy. Methods Thirty female cats were randomly allocated to receive rocuronium 0.3 mg/kg IV or an equal volume of normal saline, following induction of anesthesia with ketamine and midazolam. Thirty seconds after induction, a single investigator, unaware of treatment allocation, attempted tracheal intubation. The number of attempts and the time to complete intubation were measured. Intubating conditions were assessed as acceptable or unacceptable based on a composite score consisting of five different components. Duration of apnea after induction was measured and cases of hemoglobin desaturation (SpO 2 <90%) were identified. Results Intubation was completed faster (rocuronium 12 s [range 8-75 s]; saline 60 s [range 9-120 s]) and with fewer attempts (rocuronium 1 [range 1-2]; saline 2 [range 1-3], both P = 0.006) in cats receiving rocuronium. Unacceptable intubating conditions on the first attempt occurred in 3/15 cats with rocuronium and in 10/15 with saline ( P = 0.01). Apnea lasted 4 ± 1.6 mins with rocuronium and 2.3 ± 0.5 mins with saline ( P = 0.0007). No cases of desaturation were observed. Conclusions and relevance Rocuronium 0.3 mg/kg IV improves intubating conditions compared with saline and reduces the time and number of attempts to intubate with only a short period of apnea in cats.

Systematic review of non-surgical therapies for osteoarthritis of the hand: an update.

PubMed

Lue, S; Koppikar, S; Shaikh, K; Mahendira, D; Towheed, T E

2017-09-01

To update our earlier systematic reviews which evaluated all published randomized controlled trials (RCTs) evaluating pharmacological and non-pharmacological therapies in patients with hand osteoarthritis (OA). Surgical therapies were not evaluated. RCTs published between March 2008 and December 2015 were added to the previous systematic reviews. A total of 95 RCTs evaluating various pharmacological and non-pharmacological therapies in hand OA were analyzed in this update. Generally, the methodological quality of these RCTs has improved since the last update, with more studies describing their methods for randomization, blinding, and allocation concealment. However, RCTs continue to be weakened by a lack of consistent case definition and a lack of standardized outcome assessments specific to hand OA. The number and location of evaluated hand joints continues to be underreported, and only 25% of RCTs adequately described the method used to ensure allocation concealment. These remain major weaknesses of published RCTs. A meta-analysis could not be performed because of marked study heterogeneity, insufficient statistical data available in the published RCTs, and a small number of identical comparators. Hand OA is a complex area in which to study the efficacy of therapies. There has been an improvement in the overall design and conduct of RCTs, however, additional large RCTs with a more robust methodological approach specific to hand OA are needed in order to make clinically relevant conclusions about the efficacy of the diverse treatment options available. Copyright © 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Protective effect of selenium on cisplatin induced nephrotoxicity: A double-blind controlled randomized clinical trial.

PubMed

Ghorbani, Ali; Omidvar, Bita; Parsi, Abazar

2013-04-01

Renal injury is common following cisplatin infusion. Some agents have been used to attenuate cisplatin nephrotoxicity. However, except hydration, none of them has been proved to be effective. In this study selenium as an antioxidant supplement was tested on cisplatin induced renal injury. 122 cancerous patients (85 male and 37 female; age range of 14 to 82 years old) were enrolled to receive chemotherapy regimens consisting cisplatin. They were allocated into two groups using a random number list . Investigators, patients and analyzers all, were blinded in allocation by using sealed opaque envelopes. Intervention group received a single 400 mcg selenium tablet and patients in control group took a placebo tablet which was similar with selenium preparation in color, weight, shape and taste. Primary end points were an increase in plasma creatinine above 1.5 mg/dl in men and 1.4mg/dl in women, or increase of plasma creatinine more than 50% from baseline or urine flow rate less than 0.5 ml/kg/h. Creatinine level was measured initially and on the 5th day after cisplatin therapy. There was no difference in cumulative dose of cisplatin between the groups (p=0.54). There were not evidences of acute renal failure (ARF) in cases. While, among placebo group, 7 patients had criteria of acute kidney injury. Conclusions :selenium could probably prevent cisplatin-induced acute kidney injury, when it is added to hydration therapy in cancerous patients.

Integrating cognitive bias modification into a standard cognitive behavioural treatment package for social phobia: a randomized controlled trial.

PubMed

Rapee, Ronald M; MacLeod, Colin; Carpenter, Leigh; Gaston, Jonathan E; Frei, Jacqueline; Peters, Lorna; Baillie, Andrew J

2013-05-01

The aim of the current study was to integrate recent developments in the retraining of attentional biases towards threat into a standard cognitive behavioural treatment package for social phobia. 134 participants (M age-32.4: 53% female) meeting DSM-IV criteria for social phobia received a 12-week cognitive behavioural treatment program. They were randomly allocated to receive on a daily basis using home practice, either an additional computerised probe procedure designed to train attentional resource allocation away from threat, or a placebo variant of this procedure. Measures included diagnostic severity, social anxiety symptoms, life interference, and depression as well as state anxiety in response to a laboratory social threat. At the end of treatment there were no significant differences between groups in attentional bias towards threat or in treatment response (all p's>0.05). Both groups showed similar and highly significant reductions in diagnostic severity, social anxiety symptoms, depression symptoms, and life interference at post-treatment that was maintained and in most cases increased at 6 month follow-up (uncontrolled effect sizes ranged from d=0.34 to d=1.90). The current results do not indicate that integration of information processing-derived attentional bias modification procedures into standard treatment packages as conducted in this study augments attentional change or enhances treatment efficacy. Further refinement of bias modification techniques, and better methods of integrating them with conventional approaches, may be needed to produce better effects. Copyright © 2013 Elsevier Ltd. All rights reserved.

Diagnostic precision of mentally estimated home blood pressure means.

PubMed

Ouattara, Franck Olivier; Laskine, Mikhael; Cheong, Nathalie Ng; Birnbaum, Leora; Wistaff, Robert; Bertrand, Michel; van Nguyen, Paul; Kolan, Christophe; Durand, Madeleine; Rinfret, Felix; Lamarre-Cliche, Maxime

2018-05-07

Paper home blood pressure (HBP) charts are commonly brought to physicians at office visits. The precision and accuracy of mental calculations of blood pressure (BP) means are not known. A total of 109 hypertensive patients were instructed to measure and record their HBP for 1 week and to bring their paper charts to their office visit. Study section 1: HBP means were calculated electronically and compared to corresponding in-office BP estimates made by physicians. Study section 2: 100 randomly ordered HBP charts were re-examined repetitively by 11 evaluators. Each evaluator estimated BP means four times in 5, 15, 30, and 60 s (random order) allocated for the task. BP means and diagnostic performance (determination of therapeutic systolic and diastolic BP goals attained or not) were compared between physician estimates and electronically calculated results. Overall, electronically and mentally calculated BP means were not different. Individual analysis showed that 83% of in-office physician estimates were within a 5-mmHg systolic BP range. There was diagnostic disagreement in 15% of cases. Performance improved consistently when the time allocated for BP estimation was increased from 5 to 15 s and from 15 to 30 s, but not when it exceeded 30 s. Mentally calculating HBP means from paper charts can cause a number of diagnostic errors. Chart evaluation exceeding 30 s does not significantly improve accuracy. BP-measuring devices with modern analytical capacities could be useful to physicians.

Design of clinical trials involving multiple hypothesis tests with a common control.

PubMed

Schou, I Manjula; Marschner, Ian C

2017-07-01

Randomized clinical trials comparing several treatments to a common control are often reported in the medical literature. For example, multiple experimental treatments may be compared with placebo, or in combination therapy trials, a combination therapy may be compared with each of its constituent monotherapies. Such trials are typically designed using a balanced approach in which equal numbers of individuals are randomized to each arm, however, this can result in an inefficient use of resources. We provide a unified framework and new theoretical results for optimal design of such single-control multiple-comparator studies. We consider variance optimal designs based on D-, A-, and E-optimality criteria, using a general model that allows for heteroscedasticity and a range of effect measures that include both continuous and binary outcomes. We demonstrate the sensitivity of these designs to the type of optimality criterion by showing that the optimal allocation ratios are systematically ordered according to the optimality criterion. Given this sensitivity to the optimality criterion, we argue that power optimality is a more suitable approach when designing clinical trials where testing is the objective. Weighted variance optimal designs are also discussed, which, like power optimal designs, allow the treatment difference to play a major role in determining allocation ratios. We illustrate our methods using two real clinical trial examples taken from the medical literature. Some recommendations on the use of optimal designs in single-control multiple-comparator trials are also provided. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Patients' Perceptions of an Exercise Program Delivered Following Discharge From Hospital After Critical Illness (the Revive Trial).

PubMed

Ferguson, Kathryn; Bradley, Judy M; McAuley, Daniel F; Blackwood, Bronagh; O'Neill, Brenda

2017-01-01

The REVIVE randomized controlled trial (RCT) investigated the effectiveness of an individually tailored (personalized) exercise program for patients discharged from hospital after critical illness. By including qualitative methods, we aimed to explore patients' perceptions of engaging in the exercise program. Patients were recruited from general intensive care units in 6 hospitals in Northern Ireland. Patients allocated to the exercise intervention group were invited to participate in this qualitative study. Independent semistructured interviews were conducted at 6 months after randomization. Interviews were audio-recorded, transcribed, and content analysis used to explore themes arising from the data. Of 30 patients allocated to the exercise group, 21 completed the interviews. Patients provided insight into the physical and mental sequelae they experienced following critical illness. There was a strong sense of patients' need for the exercise program and its importance for their recovery following discharge home. Key facilitators of the intervention included supervision, tailoring of the exercises to personal needs, and the exercise manual. Barriers included poor mental health, existing physical limitations, and lack of motivation. Patients' views of outcome measures in the REVIVE RCT varied. Many patients were unsure about what would be the best way of measuring how the program affected their health. This qualitative study adds an important perspective on patients' attitude to an exercise intervention following recovery from critical illness, and provides insight into the potential facilitators and barriers to delivery of the program and how programs should be evolved for future trials.

Healing pressure ulcers with collagen or hydrocolloid: a randomized, controlled trial.

PubMed

Graumlich, James F; Blough, Linda S; McLaughlin, Richard G; Milbrandt, Joseph C; Calderon, Cesar L; Agha, Syed Abbas; Scheibel, L William

2003-02-01

To compare the effects of topical collagen and hydrocolloid on pressure ulcer healing. Randomized (allocation concealed), single-blind (outcome assessors), controlled trial with 8-week follow-up. Eleven nursing homes in central Illinois. Sixty-five patient-residents with Stage II or III pressure ulcers: median age 83.1, median Braden score 12, 63% female, 80% Stage II ulcers, and 20% Stage III ulcers. Exclusion criteria included cellulitis and osteomyelitis. Thirty-five patients were allocated to topical collagen daily, 30 to topical hydrocolloid twice weekly. The primary outcome was complete healing within 8 weeks. Secondary outcomes were time to heal, ulcer area healed per day, linear healing of wound edge, and cost of therapy. Analysis by intention to treat revealed similar complete ulcer healing within 8 weeks in collagen (51%) and hydrocolloid (50%) recipients (difference 1%, 95% confidence interval (CI) = 26-29%). Mean healing time was similar: collagen healed in 5 weeks (95% CI = 4-6), hydrocolloid healed in 6 weeks (95% CI = 5-7). Mean area healed per day was 6 mm(2)/d in both treatment groups. Mean linear healing of the wound edge was 3 mm in both groups. In multivariate analysis, baseline ulcer depth was the only independent predictor of complete ulcer healing within 8 weeks (odds ratio = 0.56, 95% CI = 0.38-0.81). Cost analysis favored hydrocolloid. There were no significant differences in healing outcome between collagen and hydrocolloid. Collagen was more expensive and offered no major benefits to patients otherwise eligible for hydrocolloid treatment.