Randomized trials published in some Chinese journals: how many are randomized?

PubMed

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-07-02

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0). Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed Central

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-01-01

Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0). Conclusion Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed. PMID:19573242

Robust Takagi-Sugeno fuzzy control for fractional order hydro-turbine governing system.

PubMed

Wang, Bin; Xue, Jianyi; Wu, Fengjiao; Zhu, Delan

2016-11-01

A robust fuzzy control method for fractional order hydro-turbine governing system (FOHGS) in the presence of random disturbances is investigated in this paper. Firstly, the mathematical model of FOHGS is introduced, and based on Takagi-Sugeno (T-S) fuzzy rules, the generalized T-S fuzzy model of FOHGS is presented. Secondly, based on fractional order Lyapunov stability theory, a novel T-S fuzzy control method is designed for the stability control of FOHGS. Thirdly, the relatively loose sufficient stability condition is acquired, which could be transformed into a group of linear matrix inequalities (LMIs) via Schur complement as well as the strict mathematical derivation is given. Furthermore, the control method could resist random disturbances, which shows the good robustness. Simulation results indicate the designed fractional order T-S fuzzy control scheme works well compared with the existing method. Copyright © 2016 ISA. Published by Elsevier Ltd. All rights reserved.

Percolation in three-dimensional fracture networks for arbitrary size and shape distributions

NASA Astrophysics Data System (ADS)

Thovert, J.-F.; Mourzenko, V. V.; Adler, P. M.

2017-04-01

The percolation threshold of fracture networks is investigated by extensive direct numerical simulations. The fractures are randomly located and oriented in three-dimensional space. A very wide range of regular, irregular, and random fracture shapes is considered, in monodisperse or polydisperse networks containing fractures with different shapes and/or sizes. The results are rationalized in terms of a dimensionless density. A simple model involving a new shape factor is proposed, which accounts very efficiently for the influence of the fracture shape. It applies with very good accuracy in monodisperse or moderately polydisperse networks, and provides a good first estimation in other situations. A polydispersity index is shown to control the need for a correction, and the corrective term is modelled for the investigated size distributions.

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

PubMed

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-11-30

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

Performance-Based Scholarships: Replication at Six Sites Using Randomized Controlled Trials

ERIC Educational Resources Information Center

Mayer, Alexander

2014-01-01

Performance-based scholarships were developed to help tackle some of the financial obstacles facing students in the postsecondary education system. In general, these scholarships aim to help reduce the financial burdens of low-income college students, and are structured to help incentivize good academic progress. Performance-based scholarships…

Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1.

PubMed

Jansen, Jeroen P; Fleurence, Rachael; Devine, Beth; Itzler, Robbin; Barrett, Annabel; Hawkins, Neil; Lee, Karen; Boersma, Cornelis; Annemans, Lieven; Cappelleri, Joseph C

2011-06-01

Evidence-based health-care decision making requires comparisons of all relevant competing interventions. In the absence of randomized, controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best choice(s) of treatment. Mixed treatment comparisons, a special case of network meta-analysis, combine direct and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than a traditional meta-analysis. This report from the ISPOR Indirect Treatment Comparisons Good Research Practices Task Force provides guidance on the interpretation of indirect treatment comparisons and network meta-analysis to assist policymakers and health-care professionals in using its findings for decision making. We start with an overview of how networks of randomized, controlled trials allow multiple treatment comparisons of competing interventions. Next, an introduction to the synthesis of the available evidence with a focus on terminology, assumptions, validity, and statistical methods is provided, followed by advice on critically reviewing and interpreting an indirect treatment comparison or network meta-analysis to inform decision making. We finish with a discussion of what to do if there are no direct or indirect treatment comparisons of randomized, controlled trials possible and a health-care decision still needs to be made. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Adaptive mechanism-based congestion control for networked systems

NASA Astrophysics Data System (ADS)

Liu, Zhi; Zhang, Yun; Chen, C. L. Philip

2013-03-01

In order to assure the communication quality in network systems with heavy traffic and limited bandwidth, a new ATRED (adaptive thresholds random early detection) congestion control algorithm is proposed for the congestion avoidance and resource management of network systems. Different to the traditional AQM (active queue management) algorithms, the control parameters of ATRED are not configured statically, but dynamically adjusted by the adaptive mechanism. By integrating with the adaptive strategy, ATRED alleviates the tuning difficulty of RED (random early detection) and shows a better control on the queue management, and achieve a more robust performance than RED under varying network conditions. Furthermore, a dynamic transmission control protocol-AQM control system using ATRED controller is introduced for the systematic analysis. It is proved that the stability of the network system can be guaranteed when the adaptive mechanism is finely designed. Simulation studies show the proposed ATRED algorithm achieves a good performance in varying network environments, which is superior to the RED and Gentle-RED algorithm, and providing more reliable service under varying network conditions.

Motion control of the rabbit ankle joint with a flat interface nerve electrode.

PubMed

Park, Hyun-Joo; Durand, Dominique M

2015-12-01

A flat interface nerve electrode (FINE) has been shown to improve fascicular and subfascicular selectivity. A recently developed novel control algorithm for FINE was applied to motion control of the rabbit ankle. A 14-contact FINE was placed on the rabbit sciatic nerve (n = 8), and ankle joint motion was controlled for sinusoidal trajectories and filtered random trajectories. To this end, a real-time controller was implemented with a multiple-channel current stimulus isolator. The performance test results showed good tracking performance of rabbit ankle joint motion for filtered random trajectories and sinusoidal trajectories (0.5 Hz and 1.0 Hz) with <10% average root-mean-square (RMS) tracking error, whereas the average range of ankle joint motion was between -20.0 ± 9.3° and 18.1 ± 8.8°. The proposed control algorithm enables the use of a multiple-contact nerve electrode for motion trajectory tracking control of musculoskeletal systems. © 2015 Wiley Periodicals, Inc.

Continuous Passive Motion Provides Good Pain Control in Patients with Adhesive Capsulitis

ERIC Educational Resources Information Center

Dundar, Umit; Toktas, Hasan; Cakir, Tuncay; Evcik, Deniz; Kavuncu, Vural

2009-01-01

Painful stiffening of the shoulder, "frozen shoulder" is a common cause of shoulder pain and disability. Continuous passive motion (CPM) is an established method of preventing joint stiffness and of overcoming it. A randomized, comparative prospective clinical trial was planned to compare the early response with different rehabilitation…

Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial.

PubMed

Meinich Petersen, Sandra; Zoffmann, Vibeke; Kjærgaard, Jesper; Graff Stensballe, Lone; Graff Steensballe, Lone; Greisen, Gorm

2014-04-15

When a child participates in a clinical trial, informed consent has to be given by the parents. Parental motives for participation are complex, but the hope of getting a new and better treatment for the child is important. We wondered how parents react when their child is allocated to the control group of a randomized controlled trial, and how it will affect their future engagement in the trial. We included parents of newborns randomized to the control arm in the Danish Calmette study at Rigshospitalet in Copenhagen. The Calmette study is a randomized clinical trial investigating the non-specific effects of early BCG-vaccine to healthy neonates. Randomization is performed immediately after birth and parents are not blinded to the allocation. We set up a semi-structured focus group with six parents from four families. Afterwards we telephone-interviewed another 19 mothers to achieve saturation. Thematic analysis was used to identify themes across the data sets. The parents reported good understanding of the randomization process. Their most common reaction to allocation was disappointment, though relief was also seen. A model of reactions to being allocated to the control group was developed based on the participants' different positions along two continuities from 'Our participation in trial is not important' to 'Our participation in trial is important', and 'Vaccine not important to us' to 'Vaccine important to us'. Four very disappointed families had thought of getting the vaccine elsewhere, and one had actually had their child vaccinated. All parents involved in the focus group and the telephone interviews wanted to participate in the follow-ups planned for the Calmette study. This study identified an almost universal experience of disappointment among parents of newborns who were randomized to the control group, but also a broad expression of understanding and accepting the idea of randomization. The trial staff might use the model of reactions in understanding the parents' disappointment and in this way support their motives for participation. A generalized version might be applicable across randomized controlled trials at large. The Calmette study is registered in EudraCT (https://eudract.ema.europa.eu/) with trial number 2010-021979-85.

The effects of mindfulness eating and yoga exercise on blood sugar levels of pregnant women with gestational diabetes mellitus.

PubMed

Youngwanichsetha, Sununta; Phumdoung, Sasitorn; Ingkathawornwong, Thitiporn

2014-11-01

This randomized controlled trial was carried out to investigate the effect of mindfulness eating and yoga exercise on blood sugar levels among pregnant Thai women with GDM. Interventions promoting achievement of good glycemic control result in desired pregnancy outcomes. Little is known about the health benefits of mindfulness eating and yoga exercise on blood sugar levels among pregnant with GDM. A randomized controlled trial was carried out. Main outcome measures were capillary fasting plasma glucose, 2-h postprandial blood glucose, and hemoglobin A1c. The intervention group showed significantly reduced fasting plasma glucose, 2-h postprandial blood glucose, and glycosylated hemoglobin (HbA1c) in the intervention group (p<0.05). Mindfulness eating and yoga exercise had health benefits on glycemic control in pregnant women with GDM. It should be recommended in clinical and community health services. Copyright © 2014 Elsevier Inc. All rights reserved.

What is covered by "cancer rehabilitation" in PubMed? A review of randomized controlled trials 1990-2011.

PubMed

Gudbergsson, Sævar Berg; Dahl, Alv A; Loge, Jon Håvard; Thorsen, Lene; Oldervoll, Line M; Grov, Ellen K

2015-02-01

This focused review examines randomized controlled studies included by the term "cancer rehabilitation" in PubMed. The research questions concern the type of interventions performed and their methodological quality. Using the Medical Subject Headings (MeSH) terms: neoplasm AND rehabilitation, all articles with randomized controlled studies that included adult cancer patients, written in English, were extracted from PubMed. Papers covering physical exercise, psychiatric/psychological treatment or social support only were excluded as they had been reviewed recently. Abstracts and papers were assessed by 3 pairs of reviewers, and descriptive information was extracted systematically. Methodological quality was rated on a 10-item index scale, and the cut-off for acceptable quality was set at ≥ 8. A total of 132 (19%) of the 683 identified papers met the eligibility criteria and were assessed in detail. The papers were grouped into 5 thematic categories: 44 physical; 15 art and expressive; 47 psycho-educative; 21 emotionally supportive; and 5 others. Good quality of design was observed in 32 studies, 18 of them uni-dimensional and 14 multi-dimensional. Published randomized controlled studies on cancer rehabilitation are heterogeneous in terms of content and samples, and are mostly characterized by suboptimal design quality. Future studies should be more specific and well-designed with sufficient statistical strength.

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

PubMed Central

Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

2009-01-01

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

Impact of a clinical decision model for febrile children at risk for serious bacterial infections at the emergency department: a randomized controlled trial.

PubMed

de Vos-Kerkhof, Evelien; Nijman, Ruud G; Vergouwe, Yvonne; Polinder, Suzanne; Steyerberg, Ewout W; van der Lei, Johan; Moll, Henriëtte A; Oostenbrink, Rianne

2015-01-01

To assess the impact of a clinical decision model for febrile children at risk for serious bacterial infections (SBI) attending the emergency department (ED). Randomized controlled trial with 439 febrile children, aged 1 month-16 years, attending the pediatric ED of a Dutch university hospital during 2010-2012. Febrile children were randomly assigned to the intervention (clinical decision model; n = 219) or the control group (usual care; n = 220). The clinical decision model included clinical symptoms, vital signs, and C-reactive protein and provided high/low-risks for "pneumonia" and "other SBI". Nurses were guided by the intervention to initiate additional tests for high-risk children. The clinical decision model was evaluated by 1) area-under-the-receiver-operating-characteristic-curve (AUC) to indicate discriminative ability and 2) feasibility, to measure nurses' compliance to model recommendations. Primary patient outcome was defined as correct SBI diagnoses. Secondary process outcomes were defined as length of stay; diagnostic tests; antibiotic treatment; hospital admission; revisits and medical costs. The decision model had good discriminative ability for both pneumonia (n = 33; AUC 0.83 (95% CI 0.75-0.90)) and other SBI (n = 22; AUC 0.81 (95% CI 0.72-0.90)). Compliance to model recommendations was high (86%). No differences in correct SBI determination were observed. Application of the clinical decision model resulted in less full-blood-counts (14% vs. 22%, p-value < 0.05) and more urine-dipstick testing (71% vs. 61%, p-value < 0.05). In contrast to our expectations no substantial impact on patient outcome was perceived. The clinical decision model preserved, however, good discriminatory ability to detect SBI, achieved good compliance among nurses and resulted in a more standardized diagnostic approach towards febrile children, with less full blood-counts and more rightfully urine-dipstick testing. Nederlands Trial Register NTR2381.

Impact of a Clinical Decision Model for Febrile Children at Risk for Serious Bacterial Infections at the Emergency Department: A Randomized Controlled Trial

PubMed Central

de Vos-Kerkhof, Evelien; Nijman, Ruud G.; Vergouwe, Yvonne; Polinder, Suzanne; Steyerberg, Ewout W.; van der Lei, Johan; Moll, Henriëtte A.; Oostenbrink, Rianne

2015-01-01

Objectives To assess the impact of a clinical decision model for febrile children at risk for serious bacterial infections (SBI) attending the emergency department (ED). Methods Randomized controlled trial with 439 febrile children, aged 1 month-16 years, attending the pediatric ED of a Dutch university hospital during 2010-2012. Febrile children were randomly assigned to the intervention (clinical decision model; n=219) or the control group (usual care; n=220). The clinical decision model included clinical symptoms, vital signs, and C-reactive protein and provided high/low-risks for “pneumonia” and “other SBI”. Nurses were guided by the intervention to initiate additional tests for high-risk children. The clinical decision model was evaluated by 1) area-under-the-receiver-operating-characteristic-curve (AUC) to indicate discriminative ability and 2) feasibility, to measure nurses’ compliance to model recommendations. Primary patient outcome was defined as correct SBI diagnoses. Secondary process outcomes were defined as length of stay; diagnostic tests; antibiotic treatment; hospital admission; revisits and medical costs. Results The decision model had good discriminative ability for both pneumonia (n=33; AUC 0.83 (95% CI 0.75-0.90)) and other SBI (n=22; AUC 0.81 (95% CI 0.72-0.90)). Compliance to model recommendations was high (86%). No differences in correct SBI determination were observed. Application of the clinical decision model resulted in less full-blood-counts (14% vs. 22%, p-value<0.05) and more urine-dipstick testing (71% vs. 61%, p-value<0.05). Conclusions In contrast to our expectations no substantial impact on patient outcome was perceived. The clinical decision model preserved, however, good discriminatory ability to detect SBI, achieved good compliance among nurses and resulted in a more standardized diagnostic approach towards febrile children, with less full blood-counts and more rightfully urine-dipstick testing. Trial Registration Nederlands Trial Register NTR2381 PMID:26024532

Assessment of contamination and misclassification biases in a randomized controlled trial of a social network peer education intervention to reduce HIV risk behaviors among drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand.

PubMed

Simmons, Nicole; Donnell, Deborah; Ou, San-San; Celentano, David D; Aramrattana, Apinun; Davis-Vogel, Annet; Metzger, David; Latkin, Carl

2015-10-01

Controlled trials of HIV prevention and care interventions are susceptible to contamination. In a randomized controlled trial of a social network peer education intervention among people who inject drugs and their risk partners in Philadelphia, PA and Chiang Mai, Thailand, we tested a contamination measure based on recall of intervention terms. We assessed the recall of test, negative and positive control terms among intervention and control arm participants and compared the relative odds of recall of test versus negative control terms between study arms. The contamination measures showed good discriminant ability among participants in Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was strong evidence of diffusion and contamination. Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in experimental interventions.

Random blood glucose may be used to assess long-term glycaemic control among patients with type 2 diabetes mellitus in a rural African clinical setting.

PubMed

Rasmussen, Jon B; Nordin, Lovisa S; Rasmussen, Niclas S; Thomsen, Jakúp A; Street, Laura A; Bygbjerg, Ib C; Christensen, Dirk L

2014-12-01

To investigate the diagnostic accuracy of random blood glucose (RBG) on good glycaemic control among patients with diabetes mellitus (DM) in a rural African setting. Cross-sectional study at St. Francis' Hospital in eastern Zambia. RBG and HbA1c were measured during one clinical review only. Other information obtained was age, sex, body mass index, waist circumference, blood pressure, urine albumin-creatinine ratio, duration since diagnosis and medication. One hundred and one patients with DM (type 1 DM = 23, type 2 DM = 78) were included. Spearman's rank correlation coefficient revealed a significant correlation between RBG and HbA1c among the patients with type 2 DM (r = 0.73, P < 0.001) but not patients with type 1 DM (r = 0.17, P = 0.44). Furthermore, in a multivariate linear regression model (R(2) = 0.71) RBG (per mmol/l increment) (B = 0.28, 95% CI:0.24-0.32, P < 0.001) was significantly associated with HbA1c among the patients with type 2 DM. Based on ROC analysis (AUC = 0.80, SE = 0.05), RBG ≤7.5 mmol/l was determined as the optimal cut-off value for good glycaemic control (HbA1c <7.0% [53 mmol/mol]) among patients with type 2 DM (sensitivity = 76.7%; specificity = 70.8%; positive predictive value = 62.2%; negative predictive value = 82.9%). Random blood glucose could possibly be used to assess glycaemic control among patients with type 2 DM in rural settings of sub-Saharan Africa. © 2014 John Wiley & Sons Ltd.

Reducing Physical Violence Toward Primary School Students With Disabilities.

PubMed

Devries, Karen; Kuper, Hannah; Knight, Louise; Allen, Elizabeth; Kyegombe, Nambusi; Banks, Lena Morgon; Kelly, Susan; Naker, Dipak

2018-03-01

We tested whether the Good School Toolkit reduces physical violence from peers and school staff toward students with and without disabilities in Ugandan primary schools. We conducted a cluster randomized controlled trial, with data collected via cross-sectional surveys in 2012 and 2014. Forty-two primary schools in Luwero District, Uganda, were randomly assigned to receive the Good School Toolkit for 18 months, or to a waitlisted control group. The primary outcome was past week physical violence from school staff, measured by primary 5, 6, and 7 students' (aged 11-14 years) self-reports using the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool-Child Institutional. Disability was assessed through the six Short Set Washington Group questions on functioning. Analyses were by intention to treat. At endline, 53% of control group students with no functional difficulties reported violence from peers or school staff, versus 84% of students with a disability. Prevalence of past week physical violence from school staff was lower in intervention schools than in the control schools after the intervention, in students with no functional difficulties (adjusted odds ratio [aOR] = .41, 95% confidence interval [CI .26-.65]), students with some functional difficulties (aOR = .36, 95% CI .21-.63), and students with disabilities (aOR = .29, 95% CI .14-.59). The intervention also reduced violence from peers in young adolescents, with no evidence of a difference in effect by disability status. The Good School Toolkit is an effective intervention to reduce violence perpetrated by peers and school staff against young adolescents with disabilities in Ugandan primary schools. Copyright © 2017 The Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

A Six-Month Randomized Controlled Trial of Whole Soy and Isoflavones Daidzein on Body Composition in Equol-Producing Postmenopausal Women with Prehypertension

PubMed Central

Liu, Zhao-min; Ho, Suzanne C.; Chen, Yu-ming; Woo, Jean

2013-01-01

Objectives. This paper reported the effects of commonly used whole soy foods (soy flour) and purified daidzein (one of the major isoflavones and the precursor of equol) on changes in anthropometric measurements and body composition in a 6-month double-blind, randomized, placebo-controlled trial among prehypertensive postmenopausal women who are also equol producers. Methods. 270 eligible women were randomized to either one of the three treatments: 40 g soy flour (whole soy group), 40 g low-fat milk powder + 63 mg daidzein (daidzein group), or 40 g low-fat milk powder (placebo group) daily each for 6 months. Anthropometric indicators and body composition were measured before and after intervention. Results. 253 subjects completed the study with good compliance. Urinary isoflavones levels suggested good compliance of subjects with supplementation. Whole soy and purified daidzein had no significant effect on body weight, body mass index (BMI), waist and hip circumferences, waist to hip ratio (WHR), body fat percentage, fat mass, and free fat mass. Conclusion. Six-month consumption of whole soy and purified daidzein at provided dosage had no improvement on body weight and composition compared with isocaloric milk placebo among prehypertensive equol-producing postmenopausal women. This trial is registered with ClinicalTrials.gov NCT01270737. PMID:23984051

Effectiveness of peer-led education on knowledge, attitude and risk behavior practices related to HIV among students at a Malaysian public university--a randomized controlled trial.

PubMed

Ibrahim, Normala; Rampal, Lekhraj; Jamil, Zubaidah; Zain, Azhar Mohd

2012-11-01

Develop, implement and evaluate the effectiveness of a peer-led education program related to HIV/AIDS among university students. randomized controlled trial with 276 university students at Faculty of Medicine and Health Sciences University Putra Malaysia (UPM), Serdang in 2011. A peer-led education program on HIV prevention by university students. differences in knowledge, attitude and risk behavior practices related to HIV between baselines, immediate follow-up after intervention and after three months. Significant improvement in sound knowledge in the intervention group as compared to the control group (Odds ratio, 1.75; 95% CI 1.01, 3.00; p=0.04) and improvement in good attitude related to HIV (Odds ratio 2.22; 95% CI 1.37, 3.61; p=0.01). The odds of high substance risk behavior was significantly reduced in the intervention group as compared to the control group (Odds ratio 0.07; 95% CI 0.02, 0.34; p=0.01). The association between good knowledge and intervention was modified by the different time points (baseline, immediately after intervention and 3 months after intervention), ethnicity and gender. Peer-led education program in HIV prevention improves knowledge, attitude and substance risk behavior. Changes in sexual risk behavior may require a longer follow-up. Copyright © 2012 Elsevier Inc. All rights reserved.

Complementary and alternative medicine for rheumatic diseases: A systematic review of randomized controlled trials.

PubMed

Phang, Jie Kie; Kwan, Yu Heng; Goh, Hendra; Tan, Victoria Ie Ching; Thumboo, Julian; Østbye, Truls; Fong, Warren

2018-04-01

To summarize all good quality randomized controlled trials (RCTs) using complementary and alternative medicine (CAM) interventions in patients with rheumatic diseases. A systematic literature review guided by the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) was performed. We excluded non-English language articles and abstract-only publications. Due to the large number of RCTs identified, we only include "good quality" RCTs with Jadad score of five. We identified 60 good quality RCTs using CAM as intervention for patients with rheumatic diseases: acupuncture (9), Ayurvedic treatment (3), homeopathic treatment (3), electricity (2), natural products (31), megavitamin therapies (8), chiropractic or osteopathic manipulation (3), and energy healing therapy (1). The studies do not seem to suggest a particular type of CAM is effective for all types for rheumatic diseases. However, some CAM interventions appear to be more effective for certain types of rheumatic diseases. Acupuncture appears to be beneficial for osteoarthritis but not rheumatoid arthritis. For the other therapeutic modalities, the evidence base either contains too few trials or contains trials with contradictory findings which preclude any definitive summary. There were only minor adverse reactions observed for CAM interventions presented. We identified 60 good quality RCTs which were heterogenous in terms of interventions, disease, measures used to assess outcomes, and efficacy of CAM interventions. Evidence indicates that some CAM therapies may be useful for rheumatic diseases, such as acupuncture for osteoarthritis. Further research with larger sample size is required for more conclusive evidence regarding efficacy of CAM interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

What Is Design-Based Causal Inference for RCTs and Why Should I Use It? NCEE 2017-4025

ERIC Educational Resources Information Center

Schochet, Peter Z.

2017-01-01

Design-based methods have recently been developed as a way to analyze data from impact evaluations of interventions, programs, and policies. The impact estimators are derived using the building blocks of experimental designs with minimal assumptions, and have good statistical properties. The methods apply to randomized controlled trials (RCTs) and…

Good Grubbin': Impact of a TV Cooking Show for College Students Living off Campus

ERIC Educational Resources Information Center

Clifford, Dawn; Anderson, Jennifer; Auld, Garry; Champ, Joseph

2009-01-01

Objective: To determine if a series of 4 15-minute, theory-driven (Social Cognitive Theory) cooking programs aimed at college students living off campus improved cooking self-efficacy, knowledge, attitudes, and behaviors regarding fruit and vegetable intake. Design: A randomized controlled trial with pre-, post- and follow-up tests. Setting:…

Improving general practitioner clinical records with a quality assurance minimal intervention.

PubMed Central

Del Mar, C B; Lowe, J B; Adkins, P; Arnold, E; Baade, P

1998-01-01

BACKGROUND: Although good medical records have been associated with good care, there is considerable room for their improvement in general practice. AIM: To improve the quality of general practice medical records at minimal cost. METHOD: A total of 150 randomly sampled general practitioners (GPs) in suburban Brisbane, Australia, were randomized in a controlled trial to receive or not receive an intervention. The intervention consisted of 6 to 12 one-hour monthly meetings when the pairs of GPs assessed samples of each other's medical records using a 12-item instrument. This was developed previously by a process of consensus of general practice teachers. Mean scores of 10 medical records selected at random from before the intervention started and one year later were compared. RESULTS: After the intervention, the increase in the total score (for which the maximum possible was 18) for the intervention GPs (from a baseline of 11.5 to 12.3) was not significantly greater than for the controls (from 11.4 to 11.7). Legibility and being able to determine the doctor's assessment of the consultation were significantly improved. The post-intervention increase of 1.06 (9.3%) of the total scores of the 47% of intervention GPs who complied with the intervention was significantly greater than that for the controls. CONCLUSION: The quality assurance activity improved some components of the quality of GPs' clinical records. However, the improvement was small, and the search for activities for Australian GPs that demonstrate an improvement in the quality of their practice must continue. Images p1311-a PMID:9747547

Effects of adaptive servo-ventilation therapy on cardiac function and remodeling in patients with chronic heart failure (SAVIOR-C): study protocol for a randomized controlled trial.

PubMed

Seino, Yoshihiko; Momomura, Shin-Ichi; Kihara, Yasuki; Adachi, Hitoshi; Yasumura, Yoshio; Yokoyama, Hiroyuki

2015-01-16

Adaptive servo-ventilation (ASV) therapy, which is a form of noninvasive positive pressure ventilation therapy and uses an innovative ventilator that has simple operability and provides good patient adherence, potentially has therapeutic benefits-suppression of the deterioration and progression of chronic heart failure (CHF) and a reduction in the number of repeated hospitalizations. Therefore, ASV therapy draws attention as a novel, noninvasive nonpharmacotherapy for patients with CHF owing to its hemodynamics-improving effect, and it is currently being accepted in real-world clinical settings in Japan. However, clinical evidence sufficient for treatment recommendation is lacking because a multicenter, randomized, controlled study of ASV therapy has never been conducted. The present study is a confirmatory, prospective, multicenter, collaborative, open-label, blinded-endpoint, parallel-group, randomized, controlled study. At 40 medical institutions in Japan, 200 Japanese outpatients with mild to severe CHF (age: ≥ 20 years; New York Heart Association classification: greater than or equal to class II) will be randomly assigned to either of the following two study groups: the ASV group, in which 100 outpatients undergo guideline-directed medical therapy and ASV therapy for 24 weeks; and the control group, in which 100 outpatients undergo only guideline-directed medical therapy for 24 weeks. The objective of the present study is to confirm whether the ASV group is superior to the control group concerning the improvement of left ventricular contractility and remodeling, both assessed by two-dimensional echocardiography. Furthermore, the present study will also secondarily examine the effects of ASV therapy on the prognosis and quality of life of patients with CHF. ASV therapy using the device has the potential to provide therapeutic benefits based on its simple operability and good patient adherence and possesses the potential to improve left ventricular contractility and remodeling. Therefore, the present study is expected to afford more solid scientific evidence regarding ASV therapy as a novel, noninvasive, nonpharmacological, in-home, long-term ventilation therapy for patients with mild to severe CHF. UMIN identifier: UMIN000006549 , registered on 17 October, 2011.

Working Memory Training in ADHD: Controlling for Engagement, Motivation, and Expectancy of Improvement (Pilot Study).

PubMed

Mawjee, Karizma; Woltering, Steven; Lai, Nathan; Gotlieb, Howell; Kronitz, Reena; Tannock, Rosemary

2017-09-01

The aim of this study was to evaluate whether a shortened-length session of CogMed Working Memory Training (CWMT) would be a suitable active control group and evaluate study protocol to aid in design refinements for a larger randomized controlled trial (RCT). Thirty-eight post-secondary students diagnosed with ADHD were randomized into 25 sessions of standard (45 min/session) or shortened (15 min/session) CWMT, or into a waitlist control group. There was no significant difference in completion rate or training index score between the standard- and shortened-length groups indicating that both groups showed improvement and put forth good effort during training. Preliminary findings suggest that shorter training sessions may induce similar levels of engagement, motivation, and expectancy of improvement in participants. We conclude that a larger scale RCT that utilizes shortened-length training as an active control group is warranted, but that a few modifications to the study protocol will be required.

Computed Tomographic Perfusion Predicts Poor Outcomes in a Randomized Trial of Endovascular Therapy.

PubMed

Wannamaker, Robert; Guinand, Taurian; Menon, Bijoy K; Demchuk, Andrew; Goyal, Mayank; Frei, Donald; Bharatha, Aditya; Jovin, Tudor G; Shankar, Jai; Krings, Timo; Baxter, Blaise; Holmstedt, Christine; Swartz, Richard; Dowlatshahi, Dar; Chan, Richard; Tampieri, Donatella; Choe, Hana; Burns, Paul; Gentile, Nina; Rempel, Jeremy; Shuaib, Ashfaq; Buck, Brian; Bivard, Andrew; Hill, Michael; Butcher, Kenneth

2018-06-01

In the ESCAPE trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times), patients with large vessel occlusions and small infarct cores identified with computed tomography (CT)/CT angiography were randomized to endovascular therapy or standard of care. CT perfusion (CTP) was obtained in some cases but was not used to select patients. We tested the hypothesis that patients with penumbral CTP patterns have higher rates of good clinical outcome. All CTP data acquired in ESCAPE patients were analyzed centrally using a semiautomated perfusion threshold-based approach. A penumbral pattern was defined as an infarct core <70 mL, penumbral volume >15 mL, and a total hypoperfused volume:core volume ratio of >1.8. The primary outcome was good functional outcome at 90 days (modified Rankin Scale score, 0-2). CTP was acquired in 138 of 316 ESCAPE patients. Penumbral patterns were present in 116 of 128 (90.6%) of patients with interpretable CTP data. The rate of good functional outcome in penumbral pattern patients (53 of 114; 46%) was higher than that in nonpenumbral patients (2 of 12; 17%; P =0.041). In penumbral patients, endovascular therapy increased the likelihood of a good clinical outcome (34 of 58; 57%) compared with those in the control group (19 of 58; 33%; odds ratio, 2.68; 95% confidence interval, 1.25-5.76; P =0.011). Only 3 of 12 nonpenumbral patients were randomized to the endovascular group, preventing an analysis of treatment effect. The majority of patients with CTP imaging in the ESCAPE trial had penumbral patterns, which were associated with better outcomes overall. Patients with penumbra treated with endovascular therapy had the greatest odds of good functional outcome. Nonpenumbral patients were much less likely to achieve good outcomes. © 2018 American Heart Association, Inc.

Randomized controlled trial of a good practice approach to treatment of childhood obesity in Malaysia: Malaysian Childhood Obesity Treatment Trial (MASCOT).

PubMed

Wafa, Sharifah W; Talib, Ruzita A; Hamzaid, Nur H; McColl, John H; Rajikan, Roslee; Ng, Lai O; Ramli, Ayiesah H; Reilly, John J

2011-06-01

Few randomized controlled trials (RCTs) of interventions for the treatment of childhood obesity have taken place outside the Western world. To test whether a good practice intervention for the treatment of childhood obesity would have a greater impact on weight status and other outcomes than a control condition in Kuala Lumpur, Malaysia. Assessor-blinded RCT of a treatment intervention in 107 obese 7- to 11-year olds. The intervention was relatively low intensity (8 hours contact over 26 weeks, group based), aiming to change child sedentary behavior, physical activity, and diet using behavior change counselling. Outcomes were measured at baseline and six months after the start of the intervention. Primary outcome was BMI z-score, other outcomes were weight change, health-related quality of life (Peds QL), objectively measured physical activity and sedentary behavior (Actigraph accelerometry over 5 days). The intervention had no significant effect on BMI z score relative to control. Weight gain was reduced significantly in the intervention group compared to the control group (+1.5 kg vs. +3.5 kg, respectively, t-test p < 0.01). Changes in health-related quality of life and objectively measured physical activity and sedentary behavior favored the intervention group. Treatment was associated with reduced rate of weight gain, and improvements in physical activity and quality of life. More substantial benefits may require longer term and more intensive interventions which aim for more substantive lifestyle changes.

Physiological and psychological effects of delivering medical news using a simulated physician-patient scenario.

PubMed

Cohen, Lorenzo; Baile, Walter F; Henninger, Evelyn; Agarwal, Sandeep K; Kudelka, Andrzej P; Lenzi, Renato; Sterner, Janet; Marshall, Gailen D

2003-10-01

We examined the acute stress response associated with having to deliver either bad or good medical news using a simulated physician-patient scenario. Twenty-five healthy medical students were randomly assigned to a bad medical news (BN), a good medical news (GN), or a control group that read magazines during the session. Self-report measures were obtained before and after the task. Blood pressure and heart rate were measured throughout the task period. Four blood samples were obtained across the task period. The BN and GN tasks produced significant increases in self-reported distress and cardiovascular responses compared with the control group. There was also a significant increase in natural killer cell function 10 min into the task in the BN group compared with the control group. The BN task was also somewhat more stressful than the GN task, as shown by the self-report and cardiovascular data. These findings suggest that a simulated physician-patient scenario produces an acute stress response in the "physician," with the delivery of bad medical news more stressful than the delivery of good medical news.

Relationship between Response to Methylphenidate Treatment in Children with ADHD and Psychopathology in Their Families

ERIC Educational Resources Information Center

Grizenko, Natalie; Kovacina, Bojan; Amor, Leila Ben; Schwartz, George; Ter-Stepanian, Marina; Joober, Ridha

2006-01-01

Objective: To compare the pattern of familial aggregation of psychopathology in children who are good responders (GR) to methylphenidate (MPH) versus those who are poor responders (PR). Method: A total of 118 clinically referred children ages 6 to 12 years, diagnosed with ADHD participated in a double-blind, placebo-controlled, randomized 2-week…

Diet quality of a pregnant, primarily African American cohort residing in the Mississippi Delta: Delta Healthy Sprouts

USDA-ARS?s Scientific Manuscript database

At no point during a woman’s life is good nutrition more important than during her reproductive years as her dietary choices affect not only her health but also that of her child. Delta Healthy Sprouts is a randomized, controlled, comparative trial testing the impact of two Maternal, Infant, and Ea...

Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

PubMed

Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

2012-07-01

Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

A randomized controlled trial of positioning treatments in infants with positional head shape deformities.

PubMed

Hutchison, B Lynne; Stewart, Alistair W; De Chalain, Tristan B; Mitchell, Edwin A

2010-10-01

Randomized controlled trials of treatment for deformational plagiocephaly and brachycephaly have been lacking in the literature. Infants (n = 126) presenting to a plagiocephaly clinic were randomized to either positioning strategies or to positioning plus the use of a Safe T Sleep™ positioning wrap. Head shape was measured using a digital photographic technique, and neck function was assessed. They were followed up at home 3, 6 and 12 months later. There was no difference in head shape outcomes for the two treatment groups after 12 months of follow-up, with 42% of infants having head shapes in the normal range by that time. Eighty per cent of children showed good improvement. Those that had poor improvement were more likely to have both plagiocephaly and brachycephaly and to have presented later to clinic. Most infants improved over the 12-month study period, although the use of a sleep positioning wrap did not increase the rate of improvement. © 2010 The Author(s)/Journal Compilation © 2010 Foundation Acta Paediatrica.

The GOOD life: Study protocol for a social norms intervention to reduce alcohol and other drug use among Danish adolescents.

PubMed

Stock, Christiane; Vallentin-Holbech, Lotte; Rasmussen, Birthe Marie

2016-08-03

It is currently unknown if school-based social norms interventions are effective in preventing harmful alcohol consumption and other drug use among adolescents in Denmark. This paper describes the social norms-based programme The GOOD life and the design of a cluster-randomized controlled trial to test its effectiveness. The intervention The GOOD life is composed of three social norms components representing three different communication channels, namely face-to-face communication (normative feedback session), print communication (posters) and interactive media (web application). The intervention period of 8 weeks is preceded and followed by data collection, with the follow-up taking place 3 months after baseline. Public schools in the Region of Southern Denmark with grades 8 and 9 are invited to participate in the study and participating schools are randomly allocated to either intervention or control schools. The aim is to recruit a total of 39 schools and a sample of 1.400 pupils for the trial. An online questionnaire is conducted to examine the use of alcohol, tobacco and marijuana as well as the perceived frequency of use among peers of their own grade, which is measured before and after the intervention. Baseline data is used to develop social norms messages which are included in the three intervention components. Primary outcomes are binge drinking (more than 5 units at one occasion) and perceived frequency of binge drinking among peers, while smoking, marijuana use and alcohol-related harm will be assessed as secondary outcomes. The GOOD life study will provide necessary insights on descriptive and injunctive norms regarding alcohol and other drug use among Danish adolescents. In addition, it will provide new knowledge and insight on the feasibility, implementation context and effectiveness of a newly developed social norms intervention in the Danish school context. Date of registration: 17 February 2016 (retrospectively registered) at Current Controlled Trials with study ID ISRCTN27491960.

An overview of reliability assessment and control for design of civil engineering structures

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

Field, R.V. Jr.; Grigoriadis, K.M.; Bergman, L.A.

1998-06-01

Random variations, whether they occur in the input signal or the system parameters, are phenomena that occur in nearly all engineering systems of interest. As a result, nondeterministic modeling techniques must somehow account for these variations to ensure validity of the solution. As might be expected, this is a difficult proposition and the focus of many current research efforts. Controlling seismically excited structures is one pertinent application of nondeterministic analysis and is the subject of the work presented herein. This overview paper is organized into two sections. First, techniques to assess system reliability, in a context familiar to civil engineers,more » are discussed. Second, and as a consequence of the first, active control methods that ensure good performance in this random environment are presented. It is the hope of the authors that these discussions will ignite further interest in the area of reliability assessment and design of controlled civil engineering structures.« less

[Periodontal treatment for cardiovascular risk factors: a systematic review].

PubMed

Deng, Linkai; Li, Chunjie; Li, Qian; Zhang, Yukui; Zhao, Hongwei

2013-10-01

To evaluate the efficacy of periodontal treatment for the management of cardiovascular risk factors. Eligible studies in Cochrane Controlled Trials Register/CENTRAL, PubMed, EMBASE, and China Biology Medicine disc (CBMdisc) were searched until October 13, 2011. References of the included studies were hand searched. Two reviewers assessed the risk of bias and extracted the data of the included studies in duplicate. Meta-analysis was conducted with Revman 5.1. Six randomized controlled trials involving 682 participants were included. One case had low risk of bias, another one had moderate risk of bias, and the remaining four had high risk of bias. Meta-analysis showed that periodontal treatment has no significant effect on C-reactive protein, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P > 0.05). However, the treatment had a significant effect on high-density lipoprotein cholesterol [MD = 0.05, 95% CI (0.00, 0.09), P = 0.04]. Periodontal treatment has good effects on controlling high-density lipoprotein cholesterol although more randomized controlled trials must be conducted to verify its effectiveness.

Assessment of contamination and misclassification biases in a randomized controlled trial of a social network peer education intervention to reduce HIV risk behaviors among drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand

PubMed Central

Simmons, Nicole; Donnell, Deborah; Ou, San-san; Celentano, David D.; Aramrattana, Apinun; Davis-Vogel, Annet; Metzger, David; Latkin, Carl

2015-01-01

Context Controlled trials of educational interventions are susceptible to contamination. Objectives To test a contamination measure based on recall of terms. Main study A randomized controlled trial of a social network peer education intervention among 1,123 injection drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand. Methods We assessed the recall of test, negative and positive control terms by intervention and control arm participants and compared the relative odds (OR) of recall of test vs. negative control terms between study arms. Results The contamination measure showed good discriminant ability only among participants from Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was evidence of diffusion and contamination of 4 of 5 terms tested. Conclusions Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in trials of educational interventions. PMID:25935214

Intralesional immunotherapy with tuberculin purified protein derivative (PPD) in recalcitrant wart: A randomized, placebo-controlled, double-blind clinical trial including an extra group of candidates for cryotherapy.

PubMed

Amirnia, Mehdi; Khodaeiani, Effat; Fouladi, Daniel F; Masoudnia, Sima

2016-01-01

Due to paucity of randomized clinical trials, intralesional immunotherapy has not been yet accepted as a standard therapeutic method. To examine the efficacy and safety of intralesional immunotherapy with tuberculin purified protein derivative (PPD) for treating recalcitrant wart. In this randomized, placebo-controlled, double-blind clinical trial, a total of 69 patients with recalcitrant warts received either intralesional PPD antigen (n = 35) or intralesional saline (n = 34) for six times at 2-week intervals. A third group of candidates for cryotherapy (n = 33) was also included. The decrease in lesion size (good: complete response, intermediate: 50-99% improvement, poor: <50% improvement), adverse effects and recurrence within 6-month follow-up were documented. At the final session, good, intermediate and poor responses were observed in 77.1%, 22.9% and 0% of the PPD patients; 0%, 14.7% and 85.3% of the placebo patients and 18.2%, 33.3% and 48.5% of the cryotherapy patients, respectively (PPD versus placebo: p < 0.001; PPD versus cryotherapy: p < 0.001). No significant complication was seen in the PPD group. The recurrence rate was 8.6%, 5.9% and 24.2% in the PPD, placebo and cryotherapy groups, respectively (p > 0.05). Intralesional immunotherapy with PPD antigen is highly effective and safe for treating recalcitrant warts. IRCT201407089844N3 in the Iranian Registry of Clinical Trials (IRCT).

[Hyaluronate sodium treatment for internal derangement of temporomandibular joint: a systematic review based on randomized controlled trials].

PubMed

Li, Chunjie; Zhang, Yifan; Jia, Yuanyuan; Lü, Jun; Li, Longjiang; Shi, Zong-Dao

2011-10-01

To assess the efficacy and safety of hyaluronate sodium (HS) for internal derangement of temporomandibular joint by means of systematic review on relevant randomized controlled trials. After identifing the study question of the efficacy and safety of HS for internal derangement of temporomandibular joint, Medline, Cochrane Controlled Trials Register, EMBASE, OPEN SIGLE and CBM were searched electronically till October 3rd 2010. Hand-searching covering 19 dental journals in Chinese were also performed. Risk of bias assessment, with Cochrane Collaboration's tool, and data extraction of included studies were conducted by two reviewers in duplicate. Meta analysis was done with Revman 5.0.23 and the quality of evidence was evaluated by GRADE. 10 randomized controlled trials met the eligibility criteria and were included. All these studies had unclear risk of bias. When compared with negative control, HS showed a significant advantage on maximal mouth opening in short and long-term (P < 0.05), and clinical overall assessment in short-term (P < 0.05), but its effect on pain control and long-term effect on clinical overall assessment had no extra benefit (P > 0.05). Additionally, when compared with glucocorticoids, the participants who received HS injection would get a better clinical overall assessment in short-term and less adverse drug reactions (P < 0.05), but presented a similar temporomandibular joint pain relief and maximal mouth opening (P > 0.05). To a certain extent, HS had good efficacy and better safety than controls when treating internal derangement of temporomandibular joint. However, as the quality of some included studies were limited, more randomized controlled trials are needed to reinforce the conclusion.

Attack Vulnerability of Network Controllability

PubMed Central

2016-01-01

Controllability of complex networks has attracted much attention, and understanding the robustness of network controllability against potential attacks and failures is of practical significance. In this paper, we systematically investigate the attack vulnerability of network controllability for the canonical model networks as well as the real-world networks subject to attacks on nodes and edges. The attack strategies are selected based on degree and betweenness centralities calculated for either the initial network or the current network during the removal, among which random failure is as a comparison. It is found that the node-based strategies are often more harmful to the network controllability than the edge-based ones, and so are the recalculated strategies than their counterparts. The Barabási-Albert scale-free model, which has a highly biased structure, proves to be the most vulnerable of the tested model networks. In contrast, the Erdős-Rényi random model, which lacks structural bias, exhibits much better robustness to both node-based and edge-based attacks. We also survey the control robustness of 25 real-world networks, and the numerical results show that most real networks are control robust to random node failures, which has not been observed in the model networks. And the recalculated betweenness-based strategy is the most efficient way to harm the controllability of real-world networks. Besides, we find that the edge degree is not a good quantity to measure the importance of an edge in terms of network controllability. PMID:27588941

Attack Vulnerability of Network Controllability.

PubMed

Lu, Zhe-Ming; Li, Xin-Feng

2016-01-01

Controllability of complex networks has attracted much attention, and understanding the robustness of network controllability against potential attacks and failures is of practical significance. In this paper, we systematically investigate the attack vulnerability of network controllability for the canonical model networks as well as the real-world networks subject to attacks on nodes and edges. The attack strategies are selected based on degree and betweenness centralities calculated for either the initial network or the current network during the removal, among which random failure is as a comparison. It is found that the node-based strategies are often more harmful to the network controllability than the edge-based ones, and so are the recalculated strategies than their counterparts. The Barabási-Albert scale-free model, which has a highly biased structure, proves to be the most vulnerable of the tested model networks. In contrast, the Erdős-Rényi random model, which lacks structural bias, exhibits much better robustness to both node-based and edge-based attacks. We also survey the control robustness of 25 real-world networks, and the numerical results show that most real networks are control robust to random node failures, which has not been observed in the model networks. And the recalculated betweenness-based strategy is the most efficient way to harm the controllability of real-world networks. Besides, we find that the edge degree is not a good quantity to measure the importance of an edge in terms of network controllability.

Does a mineral wristband affect balance? A randomized, controlled, double-blind study.

PubMed

Hansson, Eva Ekvall; Beckman, Anders; Persson, Liselott

2015-06-26

Having good balance is a facilitating factor in the performance of everyday activities. Good balance is also essential in various sport activities in order to both get results and prevent injury. A common measure of balance is postural sway, which can be measured both antero-posteriorly and medio-laterally. There are several companies marketing wristbands whose intended function is to improve balance, strength and flexibility. Randomized controlled trials have shown that wristbands with holograms have no effect on balance but studies on wristbands with minerals seem to be lacking. The aim of this study was to investigate if the mineral wristband had any effect on postural sway in a group of healthy individuals. Randomized, controlled, double-blind study. The study group consisted of 40 healthy persons. Postural sway was measured antero-posteriorly and medio-laterally on a force plate, to compare: the mineral wristband, a placebo wristband, and without any wristband. The measurements were performed for 30 s, in four situations: with open eyes and closed eyes, standing on a firm surface and on foam. Analyses were made with multilevel technique. The use of wristband with or without minerals did not alter postural sway. Closed eyes and standing on foam both prolonged the dependent measurement, irrespective if it was medio-lateral or antero-posterior. Wearing any wristband (mineral or placebo) gave a small (0.22-0.36 mm/s) but not statistically significant reduction of postural sway compared to not wearing wristband. This study showed no effect on postural sway by using the mineral wristband, compared with a placebo wristband or no wristband. Wearing any wristband at all (mineral or placebo) gave a small but not statistically significant reduction in postural sway, probably caused by sensory input.

Evaluation of postoperative recovery in day surgery patients using a mobile phone application: a multicentre randomized trial.

PubMed

Jaensson, M; Dahlberg, K; Eriksson, M; Nilsson, U

2017-11-01

Many patients undergoing anaesthesia and surgery experience postoperative complications. Our aim was to investigate whether a systematic follow-up smartphone-based assessment, using recovery assessment by phone points (RAPP) compared with standard care, had a positive effect on day surgery patients' postoperative recovery. We also investigated whether there were differences in women and men's recovery and recovery scores. The study was a single-blind, multicentre randomized controlled trial. A total of 997 patients were randomly allocated to either RAPP or standard care. The Swedish web version of a quality of recovery (SwQoR) questionnaire was used to evaluate the patients' postoperative recovery, either on paper or using an application (RAPP) on postoperative days seven and 14. On postoperative day seven the RAPP group reported significantly better values in seven out of 24 items of the SwQoR: sleeping difficulties; not having a general feeling of wellbeing; having difficulty feeling relaxed/comfortable; and dizziness; headache; pain in the surgical wound; and a swollen surgical wound compared with the control group, implying a good postoperative recovery. Both men and women in the RAPP group reported significantly better values (and, hence good postoperative recovery) compared with the control group in the items sleeping difficulties; not having a general feeling of wellbeing and pain in the surgical wound. Measurement of patient-reported outcomes using a smartphone-based application was associated with decreased discomfort from several postoperative symptoms. Systematic e-assessment can thereby increase patients' quality of recovery and identify key areas for improvement in perioperative care. NCT02492191. © The Author 2017. Published by Oxford University Press on behalf of the British Journal of Anaesthesia.

Financial incentives and purchase restrictions in a food benefit program affect the types of foods and beverages purchased: results from a randomized trial.

PubMed

French, Simone A; Rydell, Sarah A; Mitchell, Nathan R; Michael Oakes, J; Elbel, Brian; Harnack, Lisa

2017-09-16

This research evaluated the effects of financial incentives and purchase restrictions on food purchasing in a food benefit program for low income people. Participants (n=279) were randomized to groups: 1) Incentive- 30% financial incentive for fruits and vegetables purchased with food benefits; 2) Restriction- no purchase of sugar-sweetened beverages, sweet baked goods, or candies with food benefits; 3) Incentive plus Restriction; or 4) Control- no incentive or restrictions. Participants received a study-specific debit card where funds were added monthly for 12-weeks. Food purchase receipts were collected over 16 weeks. Total dollars spent on grocery purchases and by targeted food categories were computed from receipts. Group differences were examined using general linear models. Weekly purchases of fruit significantly increased in the Incentive plus Restriction ($4.8) compared to the Restriction ($1.7) and Control ($2.1) groups (p <.01). Sugar-sweetened beverage purchases significantly decreased in the Incentive plus Restriction (-$0.8 per week) and Restriction ($-1.4 per week) groups compared to the Control group (+$1.5; p< .0001). Sweet baked goods purchases significantly decreased in the Restriction (-$0.70 per week) compared to the Control group (+$0.82 per week; p < .01). Paired financial incentives and restrictions on foods and beverages purchased with food program funds may support more healthful food purchases compared to no incentives or restrictions. Clinicaltrials.gov Identifier: NCT02643576 .

Scientific publications on portal vein thrombosis and Budd-Chiari syndrome: a global survey of the literature.

PubMed

Qi, Xingshun; Jia, Jia; Ren, Weirong; Yang, Man; De Stefano, Valerio; Wang, Juan; Fan, Daiming

2014-03-01

Portal vein thrombosis (PVT) and Budd-Chiari syndrome (BCS) are two rare vascular disorders of the liver that can lead to life-threatening complications. We conducted a global survey to systematically analyze the scientific publications in the fields of PVT and BCS. All papers regarding PVT and BCS were identified via the PubMed, EMBASE, and Cochrane library databases. The publication year, country, type of paper, study design, and number of citations were summarized. Good quality papers were defined as those in which a high proportion of homogeneous patients with BCS and/or PVT was observed. We identified 6691 and 4325 papers regarding PVT and BCS, respectively. The number of papers gradually increased over time. Researchers from the USA published the greatest number of papers (PVT: n=1418; BCS: n=888). Clinical studies were the most common type of paper (PVT: n=5395; BCS n=3171), but fewer than half of these observed more than 10 patients (PVT: n=2667/5395; BCS: n=1092/3171). Furthermore, fewer than half of the clinical studies with more than 10 patients were of good quality (PVT: 976/2667; BCS: 466/1092). According to the study design, the good quality papers were classified as cohort studies (PVT: n=865; BCS: n=421), case-control studies (PVT: n=98; BCS: n=45), and randomized controlled trials (PVT: n=13; BCS: n=0). The 5 most frequently cited original articles and guidelines/consensuses were also listed. Despite an increase in the number of papers regarding PVT and BCS over time, most of the papers had a small sample size, suggesting the necessity of large cohort studies or randomized controlled trials.

Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup.

PubMed

Hardarson, Thorir; Bungum, Mona; Conaghan, Joe; Meintjes, Marius; Chantilis, Samuel J; Molnar, Laszlo; Gunnarsson, Kristina; Wikland, Matts

2015-12-01

To study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media. Randomized, double-blinded sibling trial. Independent in vitro fertilization (IVF) clinics. One hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms. Embryos randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media. Percentage of good-quality blastocysts on day 5. Percentage of day 5 good-quality blastocysts was 21.1% (standard deviation [SD] ± 21.6%) and 22.2% (SD ± 22.1%) in the single-step time-lapse medium (G-TL) and the sequential media (G-1/G-2) groups, respectively. The mean difference (-1.2; 95% CI, -6.0; 3.6) between the two media systems for the primary end point was less than the noninferiority margin of -8%. There was a statistically significantly lower number of good-quality embryos on day 3 in the G-TL group [50.7% (SD ± 30.6%) vs. 60.8% (SD ± 30.7%)]. Four out of the 11 measured morphokinetic parameters were statistically significantly different for the two media used. The mean levels of ammonium concentration in the media at the end of the culture period was statistically significantly lower in the G-TL group as compared with the G-2 group. We have shown that a single-step culture medium supports blastocyst development equivalently to established sequential media. The ammonium concentrations were lower in the single-step media, and the measured morphokinetic parameters were modified somewhat. NCT01939626. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus

PubMed Central

Chamarthi, Bindu; Gaziano, J. Michael; Blonde, Lawrence; Scranton, Richard E.; Ezrokhi, Michael; Rutty, Dean; Cincotta, Anthony H.

2015-01-01

Background. Type 2 diabetes (T2DM) patients, including those in good glycemic control, have an increased risk of cardiovascular disease (CVD). Maintaining good glycemic control may reduce long-term CVD risk. However, other risk factors such as elevated vascular sympathetic tone and/or endothelial dysfunction may be stronger potentiators of CVD. This study evaluated the impact of bromocriptine-QR, a sympatholytic dopamine D2 receptor agonist, on progression of metabolic disease and CVD in T2DM subjects in good glycemic control (HbA1c ≤7.0%). Methods. 1834 subjects (1219 bromocriptine-QR; 615 placebo) with baseline HbA1c ≤7.0% derived from the Cycloset Safety Trial (this trial is registered with ClinicalTrials.gov Identifier: NCT00377676), a 12-month, randomized, multicenter, placebo-controlled, double-blind study in T2DM, were evaluated. Treatment impact upon a prespecified composite CVD endpoint (first myocardial infarction, stroke, coronary revascularization, or hospitalization for angina/congestive heart failure) and the odds of losing glycemic control (HbA1c >7.0% after 52 weeks of therapy) were determined. Results. Bromocriptine-QR reduced the CVD endpoint by 48% (intention-to-treat; HR: 0.52 [0.28−0.98]) and 52% (on-treatment analysis; HR: 0.48 [0.24−0.95]). Bromocriptine-QR also reduced the odds of both losing glycemic control (OR: 0.63 (0.47−0.85), p = 0.002) and requiring treatment intensification to maintain HbA1c ≤7.0% (OR: 0.46 (0.31−0.69), p = 0.0002). Conclusions. Bromocriptine-QR therapy slowed the progression of CVD and metabolic disease in T2DM subjects in good glycemic control. PMID:26060823

Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus.

PubMed

Chamarthi, Bindu; Gaziano, J Michael; Blonde, Lawrence; Vinik, Aaron; Scranton, Richard E; Ezrokhi, Michael; Rutty, Dean; Cincotta, Anthony H

2015-01-01

Type 2 diabetes (T2DM) patients, including those in good glycemic control, have an increased risk of cardiovascular disease (CVD). Maintaining good glycemic control may reduce long-term CVD risk. However, other risk factors such as elevated vascular sympathetic tone and/or endothelial dysfunction may be stronger potentiators of CVD. This study evaluated the impact of bromocriptine-QR, a sympatholytic dopamine D2 receptor agonist, on progression of metabolic disease and CVD in T2DM subjects in good glycemic control (HbA1c ≤ 7.0%). 1834 subjects (1219 bromocriptine-QR; 615 placebo) with baseline HbA1c ≤ 7.0% derived from the Cycloset Safety Trial (this trial is registered with ClinicalTrials.gov Identifier: NCT00377676), a 12-month, randomized, multicenter, placebo-controlled, double-blind study in T2DM, were evaluated. Treatment impact upon a prespecified composite CVD endpoint (first myocardial infarction, stroke, coronary revascularization, or hospitalization for angina/congestive heart failure) and the odds of losing glycemic control (HbA1c >7.0% after 52 weeks of therapy) were determined. Bromocriptine-QR reduced the CVD endpoint by 48% (intention-to-treat; HR: 0.52 [0.28-0.98]) and 52% (on-treatment analysis; HR: 0.48 [0.24-0.95]). Bromocriptine-QR also reduced the odds of both losing glycemic control (OR: 0.63 (0.47-0.85), p = 0.002) and requiring treatment intensification to maintain HbA1c ≤ 7.0% (OR: 0.46 (0.31-0.69), p = 0.0002). Bromocriptine-QR therapy slowed the progression of CVD and metabolic disease in T2DM subjects in good glycemic control.

A community-based randomized controlled trial of Mom Power parenting intervention for mothers with interpersonal trauma histories and their young children.

PubMed

Rosenblum, Katherine L; Muzik, Maria; Morelen, Diana M; Alfafara, Emily A; Miller, Nicole M; Waddell, Rachel M; Schuster, Melisa M; Ribaudo, Julie

2017-10-01

We conducted a study to evaluate the effectiveness of Mom Power, a multifamily parenting intervention to improve mental health and parenting among high-risk mothers with young children in a community-based randomized controlled trial (CB-RCT) design. Participants (N = 122) were high-risk mothers (e.g., interpersonal trauma histories, mental health problems, poverty) and their young children (age <6 years), randomized either to Mom Power, a parenting intervention (treatment condition), or weekly mailings of parenting information (control condition). In this study, the 13-session intervention was delivered by community clinicians trained to fidelity. Pre- and post-trial assessments included mothers' mental health symptoms, parenting stress and helplessness, and connection to care. Mom Power was delivered in the community with fidelity and had good uptake (>65%) despite the risk nature of the sample. Overall, we found improvements in mental health and parenting stress for Mom Power participants but not for controls; in contrast, control mothers increased in parent-child role reversal across the trial period. The benefits of Mom Power treatment (vs. control) were accentuated for mothers with interpersonal trauma histories. Results of this CB-RCT confirm the effectiveness of Mom Power for improving mental health and parenting outcomes for high-risk, trauma-exposed women with young children. ClinicalTrials.gov Identifier: NCT01554215.

Effect of a social intervention of choice vs. control on depressive symptoms, melancholy, feeling of loneliness, and perceived togetherness in older Finnish people: a randomized controlled trial.

PubMed

Pynnönen, Katja; Törmäkangas, Timo; Rantanen, Taina; Tiikkainen, Pirjo; Kallinen, Mauri

2018-01-01

This study examined effects of a social intervention on depressive symptoms, melancholy, loneliness, and perceived togetherness in community-dwelling Finnish older people. Promotion of mental well-being in older people (GoodMood; ISRCTN78426775) was a single-blinded randomized control trial lasting 1.5 years. Two hundred and twenty-three persons aged 75-79 years reporting symptoms of loneliness or melancholy were randomized into intervention and control groups. The intervention group was allowed to choose among supervised exercise, social activity, or personal counseling. Follow-up measurements were conducted at the end of 6-month intervention, and at 3, 6, and 12 months post intervention. Number of depressive symptoms remained unchanged, while loneliness and melancholy decreased in both the intervention and control groups during the study (p < 0.001). Social integration increased in the intervention group but not in controls (p = 0.041). Attachment and guidance increased in both groups (p < 0.001). The intervention did not alleviate depressed mood. Positive changes over time were observed in loneliness, feelings of melancholy, attachment, and guidance but these occurred independently of the intervention. Our secondary analysis suggests that the intervention increased perceived social integration. In sum, the effects of the intervention were moderate only and did not expedite further overcoming depressive mood or loneliness.

Effect of health education combining diet and exercise supervision in Chinese women with perimenopausal symptoms: a randomized controlled trial.

PubMed

Xi, S; Mao, L; Chen, X; Bai, W

2017-04-01

This study aimed to evaluate the effect of health education combining diet and exercise supervision on menopausal symptoms and diet/exercise habits. The randomized controlled study enrolled 60 patients with perimenopausal syndrome (Kupperman Menopause Index (KMI) score ≥15). The participants were randomized into either an intervention group (n = 30) or a control group (n = 30). Women were interviewed with questionnaires about perimenopausal symptoms, diet pattern and exercise habit. Their height and weight were measured. Women in the intervention group received health education, diet supervision and exercise supervision twice a week while those in the control group continued as normal. The total KMI score, scores of individual symptoms, diet pattern and exercise habit were measured after intervention. The total KMI score, the individual KMI scores for paresthesia, irritability, depression/suspicious, fatigue, arthralgia/myalgia, and palpitations of the intervention group were significantly lower compared with the control group after intervention. The intake of cereal, meat, fats and oils of the intervention group were significantly lower at week 12 compared with baseline. The percentage of women with a regular exercise habit was significantly higher in the intervention group than in the control group after intervention. Twelve weeks intervention of health education combining diet and exercise supervision could improve perimenopausal symptoms and help the patients establish good living habits.

[The randomized controlled trial of the treatment for clavicular fracture by rotatory manual reduction with forceps holder and retrograde percutaneous pinning transfixation].

PubMed

Bi, Hong-zheng; Yang, Mao-qing; Tan, Yuan-chao; Fu, Song

2008-07-01

To study the curative effect and safety of rotatory manual reduction with forceps holder and retrograde percutaneous pinning transfixation in treating clavicular fracture. All 201 cases of clavicular fractures were randomly divided into treatment group (101 cases) and control group (100 cases). The treatment group was treated by rotatory manual reduction with forceps holder and retrograde percutaneous pinning transfixation. The control group was treated by open reduction and internal fixation with Kirschner pin. All cases were followed up for 4 to 21 months (mean 10.6 months). SPSS was used to analyze clinic healing time of fracture and shoulder-joint function in both two groups. After operation, 101 cases of treatment group achieved union of fracture and the clinical healing time was 28 to 49 days (mean 34.5+/-2.7 days). In control group,there were 4 cases with nonunion of fracture,the other 96 cases were union,the clinical healing time was 36 to 92 days (mean 55.3+/-4.8 days). The excellent and good rate of shoulder-joint function was 100% in treatment group and 83% in control group. By t-test and chi2-test, there was significant difference between the two groups in curative effect (P<0.05). Rotatory manual reduction with forceps holder and retrograde pinning transfixation can be used in various kinds of clavicular shaft fracture, with many virtues such as easy operation, reliable fixation, short union time of fracture, good functional recovery of shoulder-joint and no incision scar affecting appearance.

LETTER TO THE EDITOR: Mixed population Minority Game with generalized strategies

NASA Astrophysics Data System (ADS)

Jefferies, P.; Hart, M.; Johnson, N. F.; Hui, P. M.

2000-11-01

We present a quantitative theory, based on crowd effects, for the market volatility in a Minority Game played by a mixed population. Below a critical concentration of generalized strategy players, we find that the volatility in the crowded regime remains above the random coin-toss value regardless of the `temperature' controlling strategy use. Our theory yields good agreement with numerical simulations.

A Randomized Rounding Approach for Optimization of Test Sheet Composing and Exposure Rate Control in Computer-Assisted Testing

ERIC Educational Resources Information Center

Wang, Chu-Fu; Lin, Chih-Lung; Deng, Jien-Han

2012-01-01

Testing is an important stage of teaching as it can assist teachers in auditing students' learning results. A good test is able to accurately reflect the capability of a learner. Nowadays, Computer-Assisted Testing (CAT) is greatly improving traditional testing, since computers can automatically and quickly compose a proper test sheet to meet user…

Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight

USDA-ARS?s Scientific Manuscript database

Our objective was to evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control). In a prospective noninferiority, randomiz...

Associations among maternal nutrition and infant birth outcomes in a cohort of pregnant, primarily African American, rural, Southern women: Delta Healthy Sprouts

USDA-ARS?s Scientific Manuscript database

Background and aims: At no point during a woman’s life is good nutrition more important than during her reproductive years as her dietary choices affect not only her health but also that of her child. Delta Healthy Sprouts is a randomized, controlled, comparative trial testing the impact of two Ma...

Adaptive Peer Sampling with Newscast

NASA Astrophysics Data System (ADS)

Tölgyesi, Norbert; Jelasity, Márk

The peer sampling service is a middleware service that provides random samples from a large decentralized network to support gossip-based applications such as multicast, data aggregation and overlay topology management. Lightweight gossip-based implementations of the peer sampling service have been shown to provide good quality random sampling while also being extremely robust to many failure scenarios, including node churn and catastrophic failure. We identify two problems with these approaches. The first problem is related to message drop failures: if a node experiences a higher-than-average message drop rate then the probability of sampling this node in the network will decrease. The second problem is that the application layer at different nodes might request random samples at very different rates which can result in very poor random sampling especially at nodes with high request rates. We propose solutions for both problems. We focus on Newscast, a robust implementation of the peer sampling service. Our solution is based on simple extensions of the protocol and an adaptive self-control mechanism for its parameters, namely—without involving failure detectors—nodes passively monitor local protocol events using them as feedback for a local control loop for self-tuning the protocol parameters. The proposed solution is evaluated by simulation experiments.

Policy entrepreneurship in UK central government: The behavioural insights team and the use of randomized controlled trials

PubMed Central

2014-01-01

What factors explain the success of the UK Cabinet Office’s Behavioural Insights Team? To answer this question, this article applies insights from organizational theory, particularly accounts of change agents. Change agents are able—with senior sponsorship—to foster innovation by determination and skill: they win allies and circumvent more traditional bureaucratic procedures. Although Behavioural Insights Team is a change agent—maybe even a skunkworks unit—not all the facilitating factors identified in the literature apply in this central government context. Key factors are its willingness to work in a non-hierarchical way, skills at forming alliances, and the ability to form good relationships with expert audiences. It has been able to promote a more entrepreneurial approach to government by using randomized controlled trials as a robust method of policy evaluation. PMID:28596638

Effects of induced social roles on the High School Personality Questionnaire.

PubMed

Merydith, S P; Wallbrown, F H

1995-08-01

A one-way multivariate analysis of variance design with a control group (regular directions) and three treatment groups using induced social roles (Faking Good, Teacher, and Ideal Teacher) as independent variables and the High School Personality Questionnaire primary scores as dependent variables was used. Subjects were 384 male high school students from Grades 9 through 12. Within each classroom, students were randomly assigned to the four groups noted above. A broad pattern of differences in scores on primary and secondary personality dimensions were obtained. Significant differences between the control (standard directions) and the Faking Good, Teacher, and Ideal Teacher roles were obtained on three secondary and most of the primary personality dimensions. In several cases the ideal social role and neutral social role showed distinct differences from the more pervasive favorable impression role.

Bacterial colonization patterns in daily chlorhexidine care at the exit site in peritoneal dialysis patients-A prospective, randomized controlled trial.

PubMed

Wang, Hsi-Hao; Hung, Shih-Yuan; Chang, Min-Yu; Lee, Yi-Che; Lin, Hsiu-Fang; Lin, Tsun-Mei; Yang, Su-Pen; Lin, Hsi-Hsun; Yang, Su-Ching; Wang, Jiun-Ling

2017-01-01

Bacterial colonization patterns in daily chlorhexidine care at the exit site in peritoneal dialysis (PD) patients were not known. We performed a prospective, randomized controlled trial enrolling 89 PD patients. After stratification by initial Staphylococcus aureus (SA) carrier status, patients were randomly assigned to receive daily 4% chlorhexidine care (intervention group) or normal saline (control group) at the exit site. Monthly, we cultured bacteria from the exit site and nasal swabs for 1 year. The SA colonization rates at exit site at 6 and 12 months were significantly lower in the intervention group than the control group (5.0% vs. 22.9%, p = 0.023 and 8.6% vs. 28.1%, p = 0.037 for 6 and 12 months, respectively). The Methicillin-resistant SA (MRSA) colonization rate at exit site at 6 months was similar (5.7% vs. 2.5%,p = 0.596) in control and intervention group, but significantly lower in the intervention group than the control group at exit site at 12months (0% vs. 12.5%, p = 0.047). The gram-negative bacilli (GNB) colonization rates were similar between the intervention and control groups at 6 and 12 months. Genotyping of all MRSA isolates showed ST (sequence type) 59 was the most predominant clone. In conclusion, chlorhexidine care at the exit site in PD patients may be a good strategy for SA and MRSA decolonization. ClinicalTrials.gov NCT02446158.

Comparison of two surgical procedures for use of the acellular dermal matrix graft in the treatment of gingival recessions: a randomized controlled clinical study.

PubMed

Felipe, Maria Emília M C; Andrade, Patrícia F; Grisi, Marcio F M; Souza, Sérgio L S; Taba, Mário; Palioto, Daniela B; Novaes, Arthur B

2007-07-01

The aim of this randomized, controlled, clinical investigation was to compare two surgical techniques for root coverage with the acellular dermal matrix graft to evaluate which technique provided better root coverage, a better esthetic result, and less postoperative discomfort. Fifteen patients with bilateral Miller Class I or II gingival recessions were selected. Fifteen pairs of recessions were treated and assigned randomly to the test group, and the contralateral recessions were assigned to the control group. The control group was treated with a broader flap and vertical releasing incisions; the test group was treated with the proposed surgical technique, without vertical releasing incisions. The clinical parameters evaluated were probing depth, relative clinical attachment level, gingival recession (GR), width of keratinized tissue, thickness of keratinized tissue, esthetic result, and pain evaluation. The measurements were taken before the surgeries and after 6 months. At baseline, all parameters were similar for both groups. At 6 months, a statistically significant greater reduction in GR favored the control group. The percentage of root coverage was 68.98% and 84.81% for the test and control groups, respectively. The esthetic result was equivalent between the groups, and all patients tolerated both procedures well. Both techniques provided significant root coverage, good esthetic results, and similar levels of postoperative discomfort. However, the control technique had statistically significantly better results for root coverage of localized gingival recessions.

Web-Based Education Prior to Outpatient Orthopaedic Surgery Enhances Early Patient Satisfaction Scores: A Prospective Randomized Controlled Study.

PubMed

van Eck, Carola F; Toor, Aneet; Banffy, Michael B; Gambardella, Ralph A

2018-01-01

A good patient-surgeon relationship relies on adequate preoperative education and counseling. Several multimedia resources, such as web-based education tools, have become available to enhance aspects of perioperative care. The purpose of this study was to evaluate the effect of an interactive web-based education tool on perioperative patient satisfaction scores after outpatient orthopaedic surgery. It was hypothesized that web-based education prior to outpatient orthopaedic surgery enhances patient satisfaction scores. Randomized controlled trial; Level of evidence, 1. All patients undergoing knee arthroscopy with meniscectomy, chondroplasty, or anterior cruciate ligament reconstruction or shoulder arthroscopy with rotator cuff repair were eligible for inclusion and were randomized to the study or control group. The control group received routine education by the surgeon, whereas the study group received additional web-based education. At the first postoperative visit, all patients completed the OAS CAHPS (Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems) survey. Differences in patient satisfaction scores between the study and control groups were determined with an independent t test. A total of 177 patients were included (104 [59%] males; mean age, 42 ± 14 years); 87 (49%) patients were randomized to receive additional web-based education. Total patient satisfaction score was significantly higher in the study group (97 ± 5) as compared with the control group (94 ± 8; P = .019), specifically for the OAS CAHPS core measure "recovery" (92 ± 13 vs 82 ± 23; P = .001). Age, sex, race, workers' compensation status, education level, overall health, emotional health, procedure type and complexity, and addition of a video did not influence patient satisfaction scores. Supplemental web-based patient education prior to outpatient orthopaedic surgery enhances patient satisfaction scores.

Impact of red versus blue light on tolerability and efficacy of PDT: a randomized controlled trial.

PubMed

Gholam, Patrick; Bosselmann, Ina; Enk, Alexander; Fink, Christine

2018-06-01

Various light sources may be used for photodynamic therapy of actinic keratosis since photosensitizing agents are activated by different wavelengths. However, the relative impact of red and blue light irradiation on the efficacy and tolerability of therapy is controversial. The aim of this study is to compare the efficacy and tolerability of therapy with red versus blue light sources, as well as the patients' evaluation of cosmetic results, clinical response, painfulness and preferred light source for future photodynamic treatments. This is a prospective, single-center, randomized, controlled, open-label study with 28 patients undergoing elective photodynamic therapy. Red and blue light sources both showed very good results with a complete response rate of 84 % and 85 % respectively. Pain during photodynamic therapy was 6.1 vs. 5.4 (and 2.1 vs. 1.5 eight hours after therapy) on the visual analogue scale. Although these differences were statistically significant, the clinical relevance is low, since the number of therapy interruptions were equally distributed in both groups, and patients' subjective evaluation of the treatment showed no personal preference towards the light sources. Both light sources showed very good clinical results and satisfactory tolerability in this study. © 2018 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

A Comparison of Three Random Number Generators for Aircraft Dynamic Modeling Applications

NASA Technical Reports Server (NTRS)

Grauer, Jared A.

2017-01-01

Three random number generators, which produce Gaussian white noise sequences, were compared to assess their suitability in aircraft dynamic modeling applications. The first generator considered was the MATLAB (registered) implementation of the Mersenne-Twister algorithm. The second generator was a website called Random.org, which processes atmospheric noise measured using radios to create the random numbers. The third generator was based on synthesis of the Fourier series, where the random number sequences are constructed from prescribed amplitude and phase spectra. A total of 200 sequences, each having 601 random numbers, for each generator were collected and analyzed in terms of the mean, variance, normality, autocorrelation, and power spectral density. These sequences were then applied to two problems in aircraft dynamic modeling, namely estimating stability and control derivatives from simulated onboard sensor data, and simulating flight in atmospheric turbulence. In general, each random number generator had good performance and is well-suited for aircraft dynamic modeling applications. Specific strengths and weaknesses of each generator are discussed. For Monte Carlo simulation, the Fourier synthesis method is recommended because it most accurately and consistently approximated Gaussian white noise and can be implemented with reasonable computational effort.

The Good School Toolkit for reducing physical violence from school staff to primary school students: a cluster-randomised controlled trial in Uganda.

PubMed

Devries, Karen M; Knight, Louise; Child, Jennifer C; Mirembe, Angel; Nakuti, Janet; Jones, Rebecca; Sturgess, Joanna; Allen, Elizabeth; Kyegombe, Nambusi; Parkes, Jenny; Walakira, Eddy; Elbourne, Diana; Watts, Charlotte; Naker, Dipak

2015-07-01

Violence against children from school staff is widespread in various settings, but few interventions address this. We tested whether the Good School Toolkit-a complex behavioural intervention designed by Ugandan not-for-profit organisation Raising Voices-could reduce physical violence from school staff to Ugandan primary school children. We randomly selected 42 primary schools (clusters) from 151 schools in Luwero District, Uganda, with more than 40 primary 5 students and no existing governance interventions. All schools agreed to be enrolled. All students in primary 5, 6, and 7 (approximate ages 11-14 years) and all staff members who spoke either English or Luganda and could provide informed consent were eligible for participation in cross-sectional baseline and endline surveys in June-July 2012 and 2014, respectively. We randomly assigned 21 schools to receive the Good School Toolkit and 21 to a waitlisted control group in September, 2012. The intervention was implemented from September, 2012, to April, 2014. Owing to the nature of the intervention, it was not possible to mask assignment. The primary outcome, assessed in 2014, was past week physical violence from school staff, measured by students' self-reports using the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool-Child Institutional. Analyses were by intention to treat, and are adjusted for clustering within schools and for baseline school-level means of continuous outcomes. The trial is registered at clinicaltrials.gov, NCT01678846. No schools left the study. At 18-month follow-up, 3820 (92·4%) of 4138 randomly sampled students participated in a cross-sectional survey. Prevalence of past week physical violence was lower in the intervention schools (595/1921, 31·0%) than in the control schools (924/1899, 48·7%; odds ratio 0·40, 95% CI 0·26-0·64, p<0·0001). No adverse events related to the intervention were detected, but 434 children were referred to child protective services because of what they disclosed in the follow-up survey. The Good School Toolkit is an effective intervention to reduce violence against children from school staff in Ugandan primary schools. MRC, DfID, Wellcome Trust, Hewlett Foundation. Copyright © 2015 Devries et al. Open access article published under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

Snoezelen Room and Childbirth Outcome: A Randomized Clinical Trial.

PubMed

Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh

2015-05-01

One of the strategies for a good outcome and pain free childbearing is to design the delivery room. The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants' intervention vs. 66% of control participants had perinea laceration (P = 0.041). According to the findings of the present study, distracting senses in snoezelen room decreases mother's pain intensity, the length of labor, and incidence of episiotomy.

Snoezelen Room and Childbirth Outcome: A Randomized Clinical Trial

PubMed Central

Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh

2015-01-01

Background: One of the strategies for a good outcome and pain free childbearing is to design the delivery room. Objectives: The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. Patients and Methods: This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. Results: The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants’ intervention vs. 66% of control participants had perinea laceration (P = 0.041). Conclusions: According to the findings of the present study, distracting senses in snoezelen room decreases mother’s pain intensity, the length of labor, and incidence of episiotomy. PMID:26082849

Magnetic resonance imaging-three-dimensional printing technology fabricates customized scaffolds for brain tissue engineering

PubMed Central

Fu, Feng; Qin, Zhe; Xu, Chao; Chen, Xu-yi; Li, Rui-xin; Wang, Li-na; Peng, Ding-wei; Sun, Hong-tao; Tu, Yue; Chen, Chong; Zhang, Sai; Zhao, Ming-liang; Li, Xiao-hong

2017-01-01

Conventional fabrication methods lack the ability to control both macro- and micro-structures of generated scaffolds. Three-dimensional printing is a solid free-form fabrication method that provides novel ways to create customized scaffolds with high precision and accuracy. In this study, an electrically controlled cortical impactor was used to induce randomized brain tissue defects. The overall shape of scaffolds was designed using rat-specific anatomical data obtained from magnetic resonance imaging, and the internal structure was created by computer-aided design. As the result of limitations arising from insufficient resolution of the manufacturing process, we magnified the size of the cavity model prototype five-fold to successfully fabricate customized collagen-chitosan scaffolds using three-dimensional printing. Results demonstrated that scaffolds have three-dimensional porous structures, high porosity, highly specific surface areas, pore connectivity and good internal characteristics. Neural stem cells co-cultured with scaffolds showed good viability, indicating good biocompatibility and biodegradability. This technique may be a promising new strategy for regenerating complex damaged brain tissues, and helps pave the way toward personalized medicine. PMID:28553343

Computational methods of robust controller design for aerodynamic flutter suppression

NASA Technical Reports Server (NTRS)

Anderson, L. R.

1981-01-01

The development of Riccati iteration, a tool for the design and analysis of linear control systems is examined. First, Riccati iteration is applied to the problem of pole placement and order reduction in two-time scale control systems. Order reduction, yielding a good approximation to the original system, is demonstrated using a 16th order linear model of a turbofan engine. Next, a numerical method for solving the Riccati equation is presented and demonstrated for a set of eighth order random examples. A literature review of robust controller design methods follows which includes a number of methods for reducing the trajectory and performance index sensitivity in linear regulators. Lastly, robust controller design for large parameter variations is discussed.

Promoting physical activity in children with juvenile idiopathic arthritis through an internet-based program: results of a pilot randomized controlled trial.

PubMed

Lelieveld, Otto T H M; Armbrust, Wineke; Geertzen, Jan H B; de Graaf, Inez; van Leeuwen, Miek A; Sauer, Pieter J J; van Weert, Ellen; Bouma, Jelte

2010-05-01

Patients with juvenile idiopathic arthritis (JIA) are less physically active than healthy peers. Therefore, we developed an Internet-based intervention to improve physical activity (PA). The aim of this study was to examine the effectiveness of the program in improving PA. PA was determined by activity-related energy expenditure, PA level, time spent on moderate to vigorous PA, and the number of days with > or =1 hour of moderate to vigorous activity, and was assessed with a 7-day activity diary. Aerobic exercise capacity was assessed by means of a Bruce treadmill test and was recorded as maximum endurance time. Disease activity was assessed by using the JIA core set. Adherence was electronically monitored. Of 59 patients, 33 eligible patients were included and randomized in an intervention (n = 17, mean +/- SD age 10.6 +/- 1.5 years) or control waiting-list group (n = 16, mean +/- SD age 10.8 +/- 1.4 years). All patients completed baseline and T1 testing. PA significantly improved in both groups. Maximum endurance time significantly improved in the intervention group but not in the control group. In a subgroup analysis for patients with low PA (intervention: n = 7, control: n = 5), PA improved in the intervention group but not in the control group. The intervention was safe, feasible, and showed a good adherence. An Internet-based program for children with JIA ages 8-12 years directed at promoting PA in daily life effectively improves PA in those patients with low PA levels. It is also able to improve endurance and it is safe, feasible, and has good adherence.

The social marketing of safety behaviors: a quasi-randomized controlled trial of tractor retrofitting incentives.

PubMed

Sorensen, Julie A; Jenkins, Paul L; Emmelin, Maria; Stenlund, Hans; Weinehall, Lars; Earle-Richardson, Giulia B; May, John J

2011-04-01

We assessed the effect of social marketing incentives on dispositions toward retrofitting and retrofitting behavior among farmers whose tractors lacked rollover protective structures. From 2006 to 2007, we conducted a quasi-randomized controlled trial with 391 farm owners in New York and Pennsylvania surveyed before and after exposure to 1 of 3 tractor retrofitting incentive combinations. These combinations were offered in 3 trial regions; region 1 received rebates; region 2 received rebates, messages, and promotion and was considered the social marketing region; and region 3 received messages and promotion. A fourth region served as a control. The social marketing region generated the greatest increases in readiness to retrofit, intentions to retrofit, and message recall. In addition, postintervention stage of change, intentions, attitudes, subjective norms, and perceived behavioral control levels were higher among farmers who had retrofitted tractors. Our results showed that a social marketing approach (financial incentives, tailored messages, and promotion) had the greatest influence on message recall, readiness to retrofit tractors, and intentions to retrofit tractors and that behavioral measures were fairly good predictors of tractor retrofitting behaviors.

Scale of reference bias and the evolution of health.

PubMed

Groot, Wim

2003-09-01

The analysis of subjective measures of well-being-such as self-reports by individuals about their health status is frequently hampered by the problem of scale of reference bias. A particular form of scale of reference bias is age norming. In this study we corrected for scale of reference bias by allowing for individual specific effects in an equation on subjective health. A random effects ordered response model was used to analyze scale of reference bias in self-reported health measures. The results indicate that if we do not control for unobservable individual specific effects, the response to a subjective health state measure suffers from age norming. Age norming can be controlled for by a random effects estimation technique using longitudinal data. Further, estimates are presented on the rate of depreciation of health. Finally, simulations of life expectancy indicate that the estimated model provides a reasonably good fit of the true life expectancy.

Randomized controlled trial of false safety behavior elimination therapy: a unified cognitive behavioral treatment for anxiety psychopathology.

PubMed

Schmidt, Norman B; Buckner, Julia D; Pusser, Andrea; Woolaway-Bickel, Kelly; Preston, Jennifer L; Norr, Aaron

2012-09-01

We tested the efficacy of a unified cognitive-behavioral therapy protocol for anxiety disorders. This group treatment protocol, termed false safety behavior elimination therapy (F-SET), is a cognitive-behavioral approach designed for use across various anxiety disorders such as panic disorder (PD), social anxiety disorder (SAD), and generalized anxiety disorder (GAD). F-SET simplifies, as well as broadens, key therapeutic elements of empirically validated treatments for anxiety disorders to allow for easier delivery to heterogeneous groups of patients with anxiety psychopathology. Patients with a primary anxiety disorder diagnosis (N=96) were randomly assigned to F-SET or a wait-list control. Data indicate that F-SET shows good efficacy and durability when delivered to mixed groups of patients with anxieties (i.e., PD, SAD, GAD) by relatively inexperienced clinicians. Findings are discussed in the context of balancing treatment efficacy and clinical utility. Copyright © 2012. Published by Elsevier Ltd.

Hyperbaric oxygen therapy for children with autism spectrum disorder.

PubMed

Sakulchit, Teeranai; Ladish, Chris; Goldman, Ran D

2017-06-01

Question As autism spectrum disorder (ASD) is a multifactorial condition, with genetic and environmental risk factors contributing to children's unique presentation and symptom severity, a range of treatments have been suggested. Parents of children with ASD in my clinic are asking me about alternative therapies to improve their children's condition. One of those therapies is hyperbaric oxygen therapy (HBOT); commercial advertisement in the past has suggested good results with this approach. Should I recommend the use of HBOT for children with ASD? Answer Hyperbaric oxygen therapy provides a higher concentration of oxygen delivered in a chamber or tube containing higher than sea level atmospheric pressure. Case series and randomized controlled trials show no evidence to support the benefit of HBOT for children with ASD. Only 1 randomized controlled trial reported effectiveness of this treatment, and those results have yet to be repeated. Copyright© the College of Family Physicians of Canada.

What is the Optimal Strategy for Adaptive Servo-Ventilation Therapy?

PubMed

Imamura, Teruhiko; Kinugawa, Koichiro

2018-05-23

Clinical advantages in the adaptive servo-ventilation (ASV) therapy have been reported in selected heart failure patients with/without sleep-disorder breathing, whereas multicenter randomized control trials could not demonstrate such advantages. Considering this discrepancy, optimal patient selection and device setting may be a key for the successful ASV therapy. Hemodynamic and echocardiographic parameters indicating pulmonary congestion such as elevated pulmonary capillary wedge pressure were reported as predictors of good response to ASV therapy. Recently, parameters indicating right ventricular dysfunction also have been reported as good predictors. Optimal device setting with appropriate pressure setting during appropriate time may also be a key. Large-scale prospective trial with optimal patient selection and optimal device setting is warranted.

[Effects of Cangfu Congxian Decoction on Oxidative Stress in Polycystic Ovary Syndrome Patients].

PubMed

Liang, Ying; Tian, Qian-hua; Mu, Yu-xia; Du, Hui-lan

2016-06-01

To observe the effect of Cangfu Congxian Decoction (CCD) on oxidative stress in granulosa cells of polycystic ovary syndrome (PCOS) patients. Forty PCOS patients underwent in vitro fertilization-embryo transfer (IVF-ET) were assigned to the treatment group and the control group 1 according to random digit table, 20 in each group. Patients in the treatment group took CCD (200 mL, once in the morning and once in the afternoon) 2 months before IVF-ET, while those in the control group 1 took no Chinese medical decoction. Recruited were another 20 patients undergoing IVF-ET for tubal factors (as the control group 2). The clinical effect of IVF-ET were observed, including oocyte retrieval number, 2 pronuclear (2PN) fertilization rate, good quality embryo rate, clinical pregnancy rate, and ovarian hyperstimulation syndrome (OHSS) induced transplantation cancel rate. The expression of relative oxygen species (ROS) in granulosa cells was detected using cell immunofluorescence combined with confocal microscopy and FCM. Compared with the control group 1, occyte retrieval number, 2PN fertilization rate, and good quality embryo rate increased in the control group 2 and the treatment group (P <0. 05). OHSS induced transplantation cancel rate decreased in the control group 2 (P < 0.05). Fluorescence intensity of ROS decreased in the treatment group and the control group 2, as compared with the control group 1 (P < 0.01). CCD increased good quality embryo rate by down-regulating the expression of ROS protein in ovarian granulosa cells, and correcting in vivo oxidative stress.

Large-deviation theory for diluted Wishart random matrices

NASA Astrophysics Data System (ADS)

Castillo, Isaac Pérez; Metz, Fernando L.

2018-03-01

Wishart random matrices with a sparse or diluted structure are ubiquitous in the processing of large datasets, with applications in physics, biology, and economy. In this work, we develop a theory for the eigenvalue fluctuations of diluted Wishart random matrices based on the replica approach of disordered systems. We derive an analytical expression for the cumulant generating function of the number of eigenvalues IN(x ) smaller than x ∈R+ , from which all cumulants of IN(x ) and the rate function Ψx(k ) controlling its large-deviation probability Prob[IN(x ) =k N ] ≍e-N Ψx(k ) follow. Explicit results for the mean value and the variance of IN(x ) , its rate function, and its third cumulant are discussed and thoroughly compared to numerical diagonalization, showing very good agreement. The present work establishes the theoretical framework put forward in a recent letter [Phys. Rev. Lett. 117, 104101 (2016), 10.1103/PhysRevLett.117.104101] as an exact and compelling approach to deal with eigenvalue fluctuations of sparse random matrices.

Image compression-encryption algorithms by combining hyper-chaotic system with discrete fractional random transform

NASA Astrophysics Data System (ADS)

Gong, Lihua; Deng, Chengzhi; Pan, Shumin; Zhou, Nanrun

2018-07-01

Based on hyper-chaotic system and discrete fractional random transform, an image compression-encryption algorithm is designed. The original image is first transformed into a spectrum by the discrete cosine transform and the resulting spectrum is compressed according to the method of spectrum cutting. The random matrix of the discrete fractional random transform is controlled by a chaotic sequence originated from the high dimensional hyper-chaotic system. Then the compressed spectrum is encrypted by the discrete fractional random transform. The order of DFrRT and the parameters of the hyper-chaotic system are the main keys of this image compression and encryption algorithm. The proposed algorithm can compress and encrypt image signal, especially can encrypt multiple images once. To achieve the compression of multiple images, the images are transformed into spectra by the discrete cosine transform, and then the spectra are incised and spliced into a composite spectrum by Zigzag scanning. Simulation results demonstrate that the proposed image compression and encryption algorithm is of high security and good compression performance.

Error control techniques for satellite and space communications

NASA Technical Reports Server (NTRS)

Costello, Daniel J., Jr.

1989-01-01

The performance of bandwidth efficient trellis codes on channels with phase jitter, or those disturbed by jamming and impulse noise is analyzed. An heuristic algorithm for construction of bandwidth efficient trellis codes with any constraint length up to about 30, any signal constellation, and any code rate was developed. Construction of good distance profile trellis codes for sequential decoding and comparison of random coding bounds of trellis coded modulation schemes are also discussed.

Comparison of group-based outpatient physiotherapy with usual care after total knee replacement: a feasibility study for a randomized controlled trial.

PubMed

Artz, Neil; Dixon, Samantha; Wylde, Vikki; Marques, Elsa; Beswick, Andrew D; Lenguerrand, Erik; Blom, Ashley W; Gooberman-Hill, Rachael

2017-04-01

To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. A feasibility study for a randomized controlled trial. One secondary-care hospital orthopaedic centre, Bristol, UK. A total of 46 participants undergoing primary total knee replacement. The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial.

Effects of green tea (Camellia sinensis) mouthwash containing 1% tannin on dental plaque and chronic gingivitis: a double-blinded, randomized, controlled trial.

PubMed

Radafshar, Golpar; Ghotbizadeh, Mahshid; Saadat, Farshid; Mirfarhadi, Nastaran

2017-02-01

The aim of the present study was to explore the effects of Iranian green tea mouthwash containing 1% tannin on dental plaque and chronic gingivitis. In this randomized, double-blinded, parallel, controlled clinical trial, 40 volunteer dental students with a gingival index ≥1 were enrolled. At baseline, gingival, plaque, and bleeding indices were recorded and all the participants received dental polishing. Based on random allocation, 20 participants used the test and 20 used chlorhexidine mouthwash with no change in regular toothbrushing methods. The participants were asked to use 15 mL of the respective mouthwash for 1 min, twice a day for 28 days. All indices, as well as stain index, were recorded after 1 and 4 weeks post-rinsing. Data were analyzed using repeated-measures ANOVA and Bonferroni tests. Significant in-group differences, but not between-group differences, were observed in all indices after 1 and 4 weeks compared to baseline. The test mouthwash resulted in significantly less tooth staining than the control. The 1% tannin green tea mouthwash could be a safe and feasible adjunct to mechanical plaque control. The tested green tea mouthwash could be considered a good alternative for chlorhexidine in contraindicating situations. © 2015 Wiley Publishing Asia Pty Ltd.

RANDOMIZED CONTROLLED TRIAL OF PARENT-INFANT PSYCHOTHERAPY FOR PARENTS WITH MENTAL HEALTH PROBLEMS AND YOUNG INFANTS.

PubMed

Fonagy, Peter; Sleed, Michelle; Baradon, Tessa

2016-01-01

There is a dearth of good-quality research investigating the outcomes of psychoanalytic parent-infant psychotherapy (PIP). This randomized controlled trial investigated the outcomes of PIP for parents with mental health problems who also were experiencing high levels of social adversity and their young infants (<12 months). Dyads were clinically referred and randomly allocated to PIP or a control condition of standard secondary and specialist primary care treatment (n = 38 in each group). Outcomes were assessed at baseline and at 6-month and 12-month follow-ups. The primary outcome was infant development. Secondary outcomes included parent-infant interaction, maternal psychopathology, maternal representations, maternal reflective functioning, and infant attachment. There were no differential effects over time between the groups on measures of infant development, parent-infant interaction, or maternal reflective functioning. Infant attachment classifications, measured only at the 12-month follow-up, did not differ between the groups. There were favorable outcomes over time for the PIP-treated dyads relative to the control group on several measures of maternal mental health, parenting stress, and parental representations of the baby and their relationship. The findings indicate potential benefits of parent-infant psychotherapy for improving mothers' psychological well-being and their representations of their baby and the parent-infant relationship. © 2016 Michigan Association for Infant Mental Health.

Systematic review and meta-analyses of randomized controlled trials examining tinnitus management

PubMed Central

Hoare, Derek J; Kowalkowski, Victoria L; Kang, Sujin; Hall, Deborah A

2011-01-01

Objectives/Hypothesis To evaluate the existing level of evidence for tinnitus management strategies identified in the UK Department of Health's Good Practice Guideline. Study Design Systematic review of peer-reviewed literature and meta-analyses. Methods Searches were conducted in PubMed, Cambridge Scientific Abstracts, Web of Science, and EMBASE (earliest to August 2010), supplemented by hand searches in October 2010. Only randomized controlled trials that used validated questionnaire measures of symptoms (i.e., measures of tinnitus distress, anxiety, depression) were included. Results Twenty-eight randomized controlled trials met our inclusion criteria, most of which provide moderate levels of evidence for the effects they reported. Levels of evidence were generally limited by the lack of blinding, lack of power calculations, and incomplete data reporting in these studies. Only studies examining cognitive behavioral therapy were numerous and similar enough to perform meta-analysis, from which the efficacy of cognitive behavioral therapy (moderate effect size) appears to be reasonably established. Antidepressants were the only drug class to show any evidence of potential benefit. Conclusions The efficacy of most interventions for tinnitus benefit remains to be demonstrated conclusively. In particular, high-level assessment of the benefit derived from those interventions most commonly used in practice, namely hearing aids, maskers, and tinnitus retraining therapy needs to be performed. PMID:21671234

Efficacy and Safety of Gabapentin in the Treatment of Chronic Cough: A Systematic Review.

PubMed

Shi, Guanglin; Shen, Qin; Zhang, Caixin; Ma, Jun; Mohammed, Anaz; Zhao, Huan

2018-06-19

Despite recent clinical guidelines, the optimal therapeutic strategy for the management of refractory chronic cough is still a challenge. The present systematic review was designed to assess the evidence for efficacy and safety of gabapentin in the treatment of chronic cough. A systematic search of PubMed, Embase, Cochrane Library databases, and publications cited in bibliographies was performed. Articles were searched by two reviewers with a priori criteria for study selection. Seven relevant articles were identified, including two randomized controlled trials, one prospective case-series designed with consecutive patients, one retrospective case series of consecutive patients, one retrospective case series with unknown consecutive status, and two case reports comprising six and two patients, respectively. Improvements were detected in cough-specific quality of life (Leicester Cough Questionnaire score) and cough severity (visual analogue scale score) following gabapentin treatment in randomized controlled trials. The results of prospective case-series showed that the rate of overall improvement of cough and sensory neuropathy with gabapentin was 68%. Gabapentin treatment of patients with chronic cough showed superior efficacy and a good safety record compared with placebo or standard medications. Additional randomized and controlled trials are needed. Copyright©2018. The Korean Academy of Tuberculosis and Respiratory Diseases.

Comparison of oral versus rectal administration of acetaminophen with codeine in postoperative pediatric adenotonsillectomy patients.

PubMed

Owczarzak, Vicki; Haddad, Joseph

2006-08-01

To examine whether acetaminophen with codeine administered per rectum is an effective alternative for pain control compared with oral administration after an adenotonsillectomy. A prospective, randomized control study. Seventy-five children aged 1 to 5 were recruited for this study. Each child was assigned randomly to receive either rectal or oral postoperative pain medication. A journal with eight questions was kept for 10 days after the operation, and an overall survey of five questions was filled out at the first postoperative visit. Postoperative pain was adequately controlled in those patients receiving suppositories when compared with those patients receiving oral pain medication. Adverse effects and total number of doses given per day were similar. Parents found the suppositories easy to administer, and more parents would switch or consider switching from oral pain medication to suppositories if given the choice. The suppositories achieved equivalent pain control as oral medication with few side effects and good tolerance. Furthermore, many parents preferred the suppositories to oral medication in maintaining postoperative pain control because of ease of administration. If given the choice for future surgeries, many parents would switch or consider switching from oral pain medication to suppositories.

Right ventricular function during one-lung ventilation: effects of pressure-controlled and volume-controlled ventilation.

PubMed

Al Shehri, Abdullah M; El-Tahan, Mohamed R; Al Metwally, Roshdi; Qutub, Hatem; El Ghoneimy, Yasser F; Regal, Mohamed A; Zien, Haytham

2014-08-01

To test the effects of pressure-controlled (PCV) and volume-controlled (VCV) ventilation during one-lung ventilation (OLV) for thoracic surgery on right ventricular (RV) function. A prospective, randomized, double-blind, controlled, crossover study. A single university hospital. Fourteen pairs of consecutive patients scheduled for elective thoracotomy. Patients were assigned randomly to ventilate the dependent lung with PCV or VCV mode, each in a randomized crossover order using tidal volume of 6 mL/kg, I: E ratio 1: 2.5, positive end-expiratory pressure (PEEP) of 5 cm H2O and respiratory rate adjusted to maintain normocapnia. Intraoperative changes in RV function (systolic and early diastolic tricuspid annular velocity (TAV), end-systolic volume (ESV), end-diastolic volume (EDV) and fractional area changes (FAC)), airway pressures, compliance and oxygenation index were recorded. The use of PCV during OLV resulted in faster systolic (10.1±2.39 vs. 5.8±1.67 cm/s, respectively), diastolic TAV (9.2±1.99 vs. 4.6±1.42 cm/s, respectively) (p<0.001) and compliance and lower ESV, EDV and airway pressures (p<0.05) than during the use of VCV. Oxygenation indices were similar during the use of VCV and PCV. The use of PCV offers more improved RV function than the use of VCV during OLV for open thoracotomy. These results apply specifically to younger patients with good ventricular and pulmonary functions. © 2014 Elsevier Inc. All rights reserved.

Breathing exercises in upper abdominal surgery: a systematic review and meta-analysis.

PubMed

Grams, Samantha T; Ono, Lariane M; Noronha, Marcos A; Schivinski, Camila I S; Paulin, Elaine

2012-01-01

There is currently no consensus on the indication and benefits of breathing exercises for the prevention of postoperative pulmonary complications PPCs and for the recovery of pulmonary mechanics. To undertake a systematic review of randomized and quasi-randomized studies that assessed the effects of breathing exercises on the recovery of pulmonary function and prevention of PCCs after upper abdominal surgery UAS. We searched the Physiotherapy Evidence Database PEDro, Scientific Electronic Library Online SciELO, MEDLINE, and Cochrane Central Register of Controlled Trials. We included randomized controlled trials and quasi-randomized controlled trials on pre- and postoperative UAS patients, in which the primary intervention was breathing exercises without the use of incentive inspirometers. The methodological quality of the studies was rated according to the PEDro scale. Data on maximal respiratory pressures MIP and MEP, spirometry, diaphragm mobility, and postoperative complications were extracted and analyzed. Data were pooled in fixed-effect meta-analysis whenever possible. Six studies were used for analysis. Two meta-analyses including 66 participants each showed that, on the first day post-operative, the breathing exercises were likely to have induced MEP and MIP improvement treatment effects of 11.44 mmH2O (95%CI 0.88 to 22) and 11.78 mmH2O (95%CI 2.47 to 21.09), respectively. Breathing exercises are likely to have a beneficial effect on respiratory muscle strength in patients submitted to UAS, however the lack of good quality studies hinders a clear conclusion on the subject.

Comparing parecoxib and ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion: a prospective randomized double-blinded placebo-controlled trial.

PubMed

Siribumrungwong, Koopong; Cheewakidakarn, Julin; Tangtrakulwanich, Boonsin; Nimmaanrat, Sasikaan

2015-03-18

Poor postoperative pain control is frequently associated with complications and delayed discharge from a hospital. Preemptive analgesia is one of the methods suggested for reducing postoperative pain. Opioids are effective for pain control, but there known addictive properties make physicians cautious about using them. Parecoxib and ketorolac are potent non-opioid NSAIDs that are attractive alternative drugs to opioids to avoid opioid-related side effects. However, there are no good head-to-head comparisons between these two drugs in the aspect of preemptive analgesic effects in lumbar spinal fusion surgery. This study aimed to compare the efficacy in terms of postoperative pain control and safety of parecoxib with ketorolac as preemptive analgesia in posterior lumbar spinal fusion patients. A prospective, double-blinded randomized controlled trial was carried out in patients undergoing posterior lumbar spinal fusion, who were randomized into 3 groups (n = 32). Parecoxib, ketorolac or a placebo was given to each patient via injection around 30 minutes prior to incision. The efficacy of postoperative pain control was assessed by a verbal numerical rating score (0-10). And various postoperative things were monitored for analysis, such as total opioid consumption, complications, and estimated blood loss. Both the ketorolac and parecoxib groups showed significantly better early postoperative pain reduction at the postanesthesia care unit (PACU) than the control group (p < 0.05). There were no differences between the pain scores of ketorolac and parecoxib at any time points. Complications and bleeding were not significantly different between all three groups. Preemptive analgesia using both ketorolac and parecoxib showed a significantly better early postoperative pain control in the PACU than the control group in patients undergoing lumbar spinal fusion. ClinicalTrials.gov NCT01859585. Registered 15 May 2013.

[Randomized controlled trials of needle knife therapy combined with rotation traction manipulation for the treatment of cervical spondylotic radiculopathy].

PubMed

Zhou, Zhong-Liang; Su, Guo-Hong; Zheng, Bao-Zhu; Zuo, Yu-Zhu; Wei, Fu-Liang

2016-09-25

To compare the therapeutic effects between needle knife therapy combined with rotation traction manipulation and rotation traction manipulation for the treatment of cervical spondylotic radiculopathy. From November 2013 to June 2015, 80 patients with cervical spondylotic radiculopathy meeting the inclusion criteria were divided into two groups randomly:the control group in which 39 patients were treated with rotation traction manipulation, and the treatment group in which 41 patients were treated with needle knife combined with rotation traction manipulation. The patients in the control group were treated once dayly for 2 weeks, which was 1 course. The patients in the treatment group were treated with needle knife firstly once a week for 2 weeks, which was 1 course;then were treated with the same methods as the patients in the control group. The symptoms, signs score and the therapeutic effects of the two groups before and after treatment were observed. After treatment, symptoms and signs scores declined in both groups( P <0.05). The results of the treatment group were better than effects in the control group( P <0.05). In the treatment group, 19 patients got an excellent result, 16 good, 5 fair and 1 bad;while in the control group, 10 patients got an excellent result, 10 good, 16 fair and 3 bad;the results of the treatment group were better than the results of the control group( P <0.01). Needle knife combined with rotation traction manipulation is an effective method for the treatment of cervical spondylotic radiculopathy, which is better than using manipulation method simply. Needle knife therapy has follow advantages:improving local blood circulation, reducing local content of pain substance, increasing production of substances resisting pain, opening channels and collaterals, and make body reaching new static and dynamic balance on the new foundation.

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials.

PubMed

Chen, Minghao; Wei, Shiyou; Hu, Junyan; Yuan, Jing; Liu, Fenghua

2017-01-01

The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94-1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06-1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80-1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use.

Tretinoin Nanogel 0.025% Versus Conventional Gel 0.025% in Patients with Acne Vulgaris: A Randomized, Active Controlled, Multicentre, Parallel Group, Phase IV Clinical Trial

PubMed Central

Chandrashekhar, B S; Anitha, M.; Ruparelia, Mukesh; Vaidya, Pradyumna; Aamir, Riyaz; Shah, Sunil; Thilak, S; Aurangabadkar, Sanjeev; Pal, Sandeep; Saraswat, Abir

2015-01-01

Background: Conventional topical tretinoin formulation is often associated with local adverse events. Nanogel formulation of tretinoin has good physical stability and enables good penetration of tretinoin into the pilo-sebaceous glands. Aim: The present study was conducted to assess the efficacy and safety of a nanogel formulation of tretinoin as compared to its conventional gel formulation in the treatment of acne vulgaris of the face. Materials and Methods: This randomized, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by the two gel formulations locally applied once daily at night for 12 wk. Acne lesion counts (inflammatory, non-inflammatory & total) and severity grading were carried out on the monthly scheduled visits along with the tolerability assessments. Results: A total of 207 patients were randomized in the study. Reductions in the total (72.9% vs. 65.0%; p = 0.03) and inflammatory (78.1% vs. 66.9%; p = 0.02) acne lesions were reported to be significantly greater with the nanogel formulation as compared to the conventional gel formulation. Local adverse events were significantly less (p = 0.04) in the nanogel group (13.3%) as compared to the conventional gel group (24.7%). Dryness was the most common adverse event reported in both the treatment groups while peeling of skin, burning sensation and photosensitivity were reported in patients using the conventional gel only. Conclusion: In the treatment of acne vulgaris of the face, tretinoin nanogel formulation appears to be more effective and better tolerated than the conventional gel formulation. PMID:25738069

S-1 versus S-1 plus cisplatin concurrent intensity modulated radiation therapy in the treatment of esophageal squamous cell carcinoma: Study protocol for a randomized controlled phase II trial.

PubMed

Wen, Yixue; Zhao, Zhenhuan; Miao, Jidong; Yang, Qilin; Gui, Yan; Sun, Mingqiang; Tian, Honggang; Jia, Qiang; Liao, Dongbiao; Yang, Chen; Du, Xiaobo

2017-12-01

Chemotherapy regimens are often a 2-drug regimen in concurrent chemotherapy and radiotherapy for esophageal cancer (EC). However, some retrospective studies have suggested that for patients with EC receiving radiotherapy combined with 2-drug chemotherapy have the severe toxicity. And S-1 alone with the combination of radiotherapy treatment effect is good, and achieved good clinical remission rate. The purpose of this trial is compare the efficacy and toxicity of combining S-1 or S-1 plus cisplatin with radiotherapy for esophageal squamous cell carcinoma. The study is a randomized, controlled, multicenter trial, comparing S-1 versus S-1 plus cisplatin concurrent radiotherapy for patients with esophageal squamous cell carcinoma. Eighty-eight patients with unresectable or medically unfit for surgery esophageal squamous cell carcinoma (clinical stage I to III), will randomly assigned to receive four cycles (2 concomitant and 2 postradiotherapy) S-1 or S-1 plus cisplatin along with radiotherapy 60-66 Gy/30 to 33 fractions. The primary outcome is complete response rate of primary tumor which will be measured by endoscopy and computer screen at 3 months after the completion of treatment. Secondary outcomes include survival and toxicity. To our knowledge, this study protocol is the first to test the effect between S-1 versus S-1 plus cisplatin concurrent intensity modulated radiation therapy in the treatment of esophageal squamous cell carcinoma. If the result will be the same effect and fewer side effects and less costly in S-1 plus radiotherapy. It will supply more treatment selection for esophageal squamous cell carcinoma.

Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study.

PubMed

Ahn, Shin; Kim, Youn-Jung; Sohn, Chang Hwan; Seo, Dong Woo; Lim, Kyoung Soo; Donnino, Michael W; Kim, Won Young

2018-04-01

Sodium bicarbonate administration during cardiopulmonary resuscitation (CPR) is controversial. Current guidelines recommend sodium bicarbonate injection in patients with existing metabolic acidosis, but clinical trials, particularly, those involving patients with acidosis, are limited. We aimed to evaluate the efficacy of sodium bicarbonate administration in out-of-hospital cardiac arrest (OHCA) patients with severe metabolic acidosis during prolonged CPR. Prospective, double-blind, randomized placebo-controlled pilot trial was conducted between January 2015 and December 2015, at a single center emergency department (ED). After 10 minutes of CPR, patients who failed to achieve return of spontaneous circulation (ROSC) and with severe metabolic acidosis (pH<7.1 or bicarbonate <10 mEq/L) were enrolled. Sodium bicarbonate (n=25) or normal saline (n=25) were administered. The primary end point was sustained ROSC. The secondary end points were the change of acidosis and good neurologic survival. Sodium bicarbonate group had significant effect on pH (6.99 vs. 6.90, P=0.038) and bicarbonate levels (21.0 vs. 8.0 mEq/L, P=0.007). However, no significant differences showed between sodium bicarbonate and placebo groups in sustained ROSC (4.0% vs. 16.0%, P=0.349) or good neurologic survival at 1 month (0.0% vs. 4.0%, P=1.000). The use of sodium bicarbonate improved acid-base status, but did not improve the rate of ROSC and good neurologic survival. We could not draw a conclusion, but our pilot data could be used to design a larger trial to verify the efficacy of sodium bicarbonate. NCT02303548 (http://www.ClinicalTrials.gov).

Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil on post-breast surgery pain: a randomized controlled trial.

PubMed

Nonaka, Takahiro; Hara, Marie; Miyamoto, Chisato; Sugita, Michiko; Yamamoto, Tatsuo

2016-06-01

Acetaminophen is known to be a relatively weak analgesic with fewer side effects than nonsteroidal anti-inflammatory drugs (NSAIDs). This study aimed to determine whether intravenous (iv) acetaminophen produces comparable analgesic effects to those of flurbiprofen (positive control drug), an intravenously injectable NSAID, after partial mastectomies. The primary outcome assessed was pain intensity during the first 24 h after the operation, and the secondary outcome was the satisfaction rating at discharge. After obtaining Institutional Ethics Committee approval, a series of 40 consecutive female patients who were scheduled for partial mastectomies were enrolled. Participants were randomly divided into two groups: an acetaminophen (1000 mg × 3) group (group A) and a flurbiprofen (50 mg × 3) group (group F). Each drug was administered 15 min before the end of surgery, and at 6 and 12 h after the operation. Postoperative pain was evaluated using a 100-mm visual analog scale (VAS) at 3, 6, and 24 h postoperatively. Satisfaction rating was evaluated on a 5-point scale (very good, good, well, bad, and very bad). VAS scores (mm) with movement in groups A and F at 3, 6, and 24 h after the surgery were 22 vs. 28, 14 vs. 24, and 12 vs. 20.5 (median), respectively, with no significant differences between the two groups. Eighteen of 20 patients in group A and 20 of 20 patients in group F expressed a satisfaction rating of greater than good. Acetaminophen produces an equivalent analgesic effect to flurbiprofen in post-partial mastectomy patients.

Outcome of Percutaneous Release of Tennis Elbow: A Non-Randomized Controlled Trial Study.

PubMed

Panthi, Sagar; Khatri, Kishor; Kharel, Krishna; Byanjankar, Subin; Shrestha, Rahul; Sharma, Jay R; Vaishya, Raju; Agarwal, Amit Kumar; Vijay, Vipul

2017-01-02

Tennis elbow is a common disorder of the upper extremity. It can be treated conservatively in the majority of patients, but some resistant cases eventually can be treated by percutaneous release with good functional outcome. This non-randomized control trial was conducted at the Department of Orthopaedics Surgery in a tertiary care hospital from July 2015 to June 2016 on 50 patients who underwent percutaneous release of the common extensor origin using an 18 gauge hypodermic needle. These patients did not respond to conservative treatment including rest, nonsteroidal anti-inflammatory drugs (NSAIDS) and local steroid injections. The outcome was graded as Excellent, Good, Fair, and Poor. Fifty patients (50 elbows) were included in the study. Thirty-two patients were female (64%), and 18 were male (36%). The right side was affected in 37 patients (74%) and left side in 13 (26%). The time taken to achieve a completely pain-free elbow ranged from one day to two months (average of 26.2 days). Those who did not achieve a pain-free elbow had a residual pain of 1.5 to six on the visual analogue scale (VAS) (average 2.32). Excellent outcome was noticed in 24 patients (48%); Good result in eight patients (36% ); Fair in four patients (eight percent) and Poor in four patients (eight percent). Tennis elbow probably results from the degenerative tear of the common extensor origin, and a percutaneous tenotomy using an 18 gauge hypodermic needle is a simple, safe, patient-friendly, efficient, and easily reproducible method of treating tennis elbow in those who are resistant to conservative treatment, and it can be done as an outpatient procedure.

Outcome of Percutaneous Release of Tennis Elbow: A Non-Randomized Controlled Trial Study

PubMed Central

Khatri, Kishor; Kharel, Krishna; Byanjankar, Subin; Shrestha, Rahul; Sharma, Jay R; Vaishya, Raju; Agarwal, Amit kumar; Vijay, Vipul

2017-01-01

Background Tennis elbow is a common disorder of the upper extremity. It can be treated conservatively in the majority of patients, but some resistant cases eventually can be treated by percutaneous release with good functional outcome. Materials and methods This non-randomized control trial was conducted at the Department of Orthopaedics Surgery in a tertiary care hospital from July 2015 to June 2016 on 50 patients who underwent percutaneous release of the common extensor origin using an 18 gauge hypodermic needle. These patients did not respond to conservative treatment including rest, nonsteroidal anti-inflammatory drugs (NSAIDS) and local steroid injections. The outcome was graded as Excellent, Good, Fair, and Poor. Results Fifty patients (50 elbows) were included in the study. Thirty-two patients were female (64%), and 18 were male (36%). The right side was affected in 37 patients (74%) and left side in 13 (26%). The time taken to achieve a completely pain-free elbow ranged from one day to two months (average of 26.2 days). Those who did not achieve a pain-free elbow had a residual pain of 1.5 to six on the visual analogue scale (VAS) (average 2.32). Excellent outcome was noticed in 24 patients (48%); Good result in eight patients (36% ); Fair in four patients (eight percent) and Poor in four patients (eight percent). Conclusion Tennis elbow probably results from the degenerative tear of the common extensor origin, and a percutaneous tenotomy using an 18 gauge hypodermic needle is a simple, safe, patient-friendly, efficient, and easily reproducible method of treating tennis elbow in those who are resistant to conservative treatment, and it can be done as an outpatient procedure. PMID:28168130

Nitrofurantoin vs other prophylactic agents in reducing recurrent urinary tract infections in adult women: a systematic review and meta-analysis.

PubMed

Price, Jameca Renee; Guran, Larissa A; Gregory, W Thomas; McDonagh, Marian S

2016-11-01

The clinical and financial burden from bladder infections is significant. Daily antibiotic use is the recommended strategy for recurrent urinary tract infection prevention. Increasing antibiotic resistance rates, however, require immediate identification of innovative alternative prophylactic therapies. This systematic review aims to provide guidance on gaps in evidence to guide future research. The objective of this review was to provide current pooled estimates of randomized control trials comparing the effects of nitrofurantoin vs other agents in reducing recurrent urinary tract infections in adult, nonpregnant women and assess relative adverse side effects. Data sources included the following: MEDLINE, Jan. 1, 1946, to Jan. 31, 2015; Cochrane Central Register of Controlled Trials the Cochrane Database of Systematic Reviews, and web sites of the National Institute for Clinical Excellence, and the National Guideline Clearinghouse from 2000 to 2015. Randomized control trials of women with recurrent urinary tract infections comparing nitrofurantoin with any other treatment were included. A protocol for the study was developed a priori. Published guidance was followed for assessment of study quality. All meta-analyses were performed using random-effects models with Stats Direct Software. Dual review was used for all decisions and data abstraction. Twelve randomized control trials involving 1063 patients were included. One study that had a serious flaw was rated poor in quality, one study rated good, and the remainder fair. No significant differences in prophylactic antibiotic treatment with nitrofurantoin and norfloxacin, trimethoprim, sulfamethoxazole/trimethoprim, methamine hippurate, estriol, or cefaclor were found in clinical or microbiological cure in adult nonpregnant women with recurrent urinary tract infections (9 randomized control trials, 673 patients, relative risk ratio, 1.06; 95% confidence interval, 0.89-1.27; I 2 , 65%; and 12 randomized control trials, 1063 patients, relative risk ratio, 1.06; 95% confidence interval, 0.90-1.26; I 2 , 76%, respectively). Duration of prophylaxis also did not have a significant impact on outcomes. There was a statistically significant difference in overall adverse effects, with nitrofurantoin resulting in greater risk than other prophylactic treatments (10 randomized control trials, 948 patients, relative risk ratio, 2.17; 95% confidence interval, 1.34-3.50; I 2 , 61%). Overall, the majority of nitrofurantoin adverse effects were gastrointestinal, with a significant difference for withdrawals (12 randomized control trials, 1063 patients, relative risk ratio, 2.14; 95% confidence interval, 1.28-3.56; I 2 , 8%). Nitrofurantoin had similar efficacy but a greater risk of adverse events than other prophylactic treatments. Balancing the risks of adverse events, particularly gastrointestinal symptoms, with potential benefits of decreasing collateral ecological damage should be considered if selecting nitrofurantoin. Copyright © 2016 Elsevier Inc. All rights reserved.

Patient satisfaction with intravenous acetaminophen: a pooled analysis of five randomized, placebo-controlled studies in the acute postoperative setting.

PubMed

Apfel, Christian C; Souza, Kimberly; Portillo, Juan; Dalal, Poorvi; Bergese, Sergio D

2015-01-01

Intravenous (IV) acetaminophen has been shown to reduce postoperative pain and opioid consumption, which may lead to increased patient satisfaction. To determine the effect IV acetaminophen has on patient satisfaction, a pooled analysis from methodologically homogenous studies was conducted. We obtained patient-level data from five randomized, placebo-controlled studies in adults undergoing elective surgery in which patient satisfaction was measured using a 4-point categorical rating scale. The primary endpoint was "excellent" satisfaction and the secondary endpoint was "good" or "excellent" satisfaction at 24 hr after first study drug administration. Bivariate analyses were conducted using the chi-square test and Student's t-test and multivariable analyses were conducted using logistic regression analysis. Patients receiving IV acetaminophen were more than twice as likely as those who received placebo to report "excellent" patient satisfaction ratings (32.3% vs. 15.9%, respectively). Of all variables that remained statistically significant in the multivariable analysis (i.e., type of surgery, duration of anesthesia, last pain rating, and opioid consumption), IV acetaminophen had the strongest positive effect on "excellent" patient satisfaction with an odds ratio of 2.76 (95% CI 1.81-4.23). Results for "excellent" or "good" satisfaction were similar. When given as part of a perioperative analgesic regimen, IV acetaminophen was associated with significantly improved patient satisfaction.

Improvement in Growth After 1 Year of Growth Hormone Therapy in Well-Nourished Infants with Growth Retardation Secondary to Chronic Renal Failure: Results of a Multicenter, Controlled, Randomized, Open Clinical Trial

PubMed Central

Moreno, M. Llanos; Neto, Arlete; Ariceta, Gema; Vara, Julia; Alonso, Angel; Bueno, Alberto; Afonso, Alberto Caldas; Correia, António Jorge; Muley, Rafael; Barrios, Vicente; Gómez, Carlos; Argente, Jesús

2010-01-01

Background and objectives: Our aim was to evaluate the growth-promoting effect of growth hormone (GH) treatment in infants with chronic renal failure (CRF) and persistent growth retardation despite adequate nutritional and metabolic management. Design, setting, participants, & measurements: The study design included randomized, parallel groups in an open, multicenter trial comparing GH (0.33 mg/kg per wk) with nontreatment with GH during 12 months. Sixteen infants who had growth retardation, were aged 12 ± 3 months, had CRF (GFR ≤60 ml/min per 1.73 m2), and had adequate nutritional intake and good metabolic control were recruited from eight pediatric nephrology departments from Spain and Portugal. Main outcome measures were body length, body weight, bone age, biochemical and hormonal analyses, renal function, bone mass, and adverse effects. Results: Length gain in infants who were treated with GH was statistically greater (P < 0.05) than that of nontreated children (14.5 versus 9.5 cm/yr; SD score 1.43 versus −0.11). The GH-induced stimulation of growth was associated with no undesirable effects on bone maturation, renal failure progression, or metabolic control. In addition, GH treatment improved forearm bone mass and increased serum concentrations of total and free IGF-I and IGF-binding protein 3 (IGFBP-3), whereas IGF-II, IGFBP-1, IGFBP-2, GH-binding protein, ghrelin, and leptin were not modified. Conclusions: Infants with CRF and growth retardation despite good metabolic and nutritional control benefit from GH treatment without adverse effects during 12 months of therapy. PMID:20522533

A randomized, open-label, standard controlled, parallel group study of efficacy and safety of baclofen, and chlordiazepoxide in uncomplicated alcohol withdrawal syndrome.

PubMed

Girish, K; Vikram Reddy, K; Pandit, Lakshmi V; Pundarikaksha, H P; Vijendra, R; Vasundara, K; Manjunatha, R; Nagraj, Moulya; Shruthi, R

2016-02-01

Alcohol withdrawal syndrome (AWS) is a distressing condition, generally controlled by benzodiazepines (BZD's). Baclofen, a gamma-aminobutyric acid-B (GABAB) agonist, has also shown promising results in controlling AWS. As there are few studies comparing the efficacy and tolerability of chlordiazepoxide with baclofen, the present study was taken up. The objective of this study was to compare efficacy and tolerability of baclofen with chlordiazepoxide in uncomplicated AWS. Sixty subjects with uncomplicated AWS were randomized into two groups of 30 each, to receive baclofen (30 mg) or chlordiazepoxide (75 mg) in decremented fixed dose regime for 9 days. Clinical efficacy was assessed by Clinical Institute Withdrawal Assessment for Alcohol-Revised Scale (CIWA-Ar) and tolerability by the nature and severity of adverse events. Lorazepam was used as rescue medication. Secondary efficacy parameters were Clinical Global Impression scores, symptom-free days, and subject satisfaction as assessed by visual analog scale. This study was registered with Clinical Trial Registry-India (CTRI/2013/04/003588), also subsequently registered with WHO's ICTRP clinical trial portal. Both baclofen and chlordiazepoxide showed a consistent reduction in the total CIWA-Ar scores. However, chlordiazepoxide showed a faster and a more effective control of anxiety and agitation requiring lesser lorazepam supplementation, and also showed a better subject satisfaction compared to baclofen. Both the drugs showed good tolerability with mild self-limiting adverse events. The present study demonstrates that baclofen is not as good as chlordiazepoxide in the treatment of uncomplicated AWS. However, baclofen might be considered as an alternative. Copyright © 2016 Chang Gung University. Published by Elsevier B.V. All rights reserved.

Increasing older adults’ walking through primary care: results of a pilot randomized controlled trial

PubMed Central

Mutrie, Nanette

2012-01-01

Background. Physical activity can positively influence health for older adults. Primary care is a good setting for physical activity promotion. Objective. To assess the feasibility of a pedometer-based walking programme in combination with physical activity consultations. Methods. Design: Two-arm (intervention/control) 12-week randomized controlled trial with a 12-week follow-up for the intervention group. Setting: One general practice in Glasgow, UK. Participants: Participants were aged ≥65 years. The intervention group received two 30-minute physical activity consultations from a trained practice nurse, a pedometer and a walking programme. The control group continued as normal for 12 weeks and then received the intervention. Both groups were followed up at 12 and 24 weeks. Outcome measures: Step counts were measured by sealed pedometers and an activPALTM monitor. Psychosocial variables were assessed and focus groups conducted. Results. The response rate was 66% (187/284), and 90% of those randomized (37/41) completed the study. Qualitative data suggested that the pedometer and nurse were helpful to the intervention. Step counts (activPAL) showed a significant increase from baseline to week 12 for the intervention group, while the control group showed no change. Between weeks 12 and 24, step counts were maintained in the intervention group, and increased for the control group after receiving the intervention. The intervention was associated with improved quality of life and reduced sedentary time. Conclusions. It is feasible to recruit and retain older adults from primary care and help them increase walking. A larger trial is necessary to confirm findings and consider cost-effectiveness. PMID:22843637

Theory-based self-management educational interventions on patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Zhao, Fang-Fang; Suhonen, Riitta; Koskinen, Sanna; Leino-Kilpi, Helena

2017-04-01

To synthesize the effects of theory-based self-management educational interventions on patients with type 2 diabetes (T2DM) in randomized controlled trials. Type 2 diabetes is a common chronic disease causing complications that put a heavy burden on society and reduce the quality of life of patients. Good self-management of diabetes can prevent complications and improve the quality of life of T2DM patients. Systematic review with meta-analysis of randomized controlled trials following Cochrane methods. A literature search was carried out in the MEDLINE, EMBASE, CINAHL, PSYCINFO, and Web of Science databases (1980-April 2015). The risk of bias of these eligible studies was assessed independently by two authors using the Cochrane Collaboration's tool. The Publication bias of the main outcomes was examined. Statistical heterogeneity and random-effects model were used for meta-analysis. Twenty studies with 5802 participants met the inclusion criteria. The interventions in the studies were based on one or more theories which mostly belong to mid-range theories. The pooled main outcomes by random-effects model showed significant improvements in HbA1c, self-efficacy, and diabetes knowledge, but not in BMI. As for quality of life, no conclusions can be drawn as the pooled outcome became the opposite with reduced heterogeneity after one study was excluded. No significant publication bias was found in the main outcomes. To get theory-based interventions to produce more effects, the role of patients should be more involved and stronger and the education team should be trained beyond the primary preparation for the self-management education program. © 2016 John Wiley & Sons Ltd.

Polydextrose: its impact on short-term food intake and subjective feelings of satiety in males-a randomized controlled cross-over study.

PubMed

Ranawana, Viren; Muller, Adelaide; Henry, C Jeya K

2013-04-01

Polydextrose is a low-calorie highly branched-chain glucose polymer that is poorly digested in the upper gastrointestinal tract and therefore demonstrates fibre-like properties. Fibre has been shown to increase satiety and possibly reduce food intake. Therefore, the objective of the current study was to examine the effects of polydextrose on short-term satiety and energy intake. In a repeated-measures randomized blind cross-over design, 26 healthy males consumed a 400-g fruit smoothie containing 12 g (3 %) of polydextrose, and a buffet lunch 60 min after the smoothie. Motivational ratings for satiety and palatability and lunch energy intake were measured. The effects of the polydextrose-containing smoothie were compared against a polydextrose-free control smoothie. Polydextrose did not significantly alter the taste and palatability of the fruit smoothie. Consuming the polydextrose-containing smoothie resulted in a significantly lower energy intake at lunch (102 kcal less) compared to the control. Polydextrose may be a good fortificant for reducing short-term food intake.

Cognitive remediation for individuals with psychosis in a supported education setting: a randomized controlled trial.

PubMed

Kidd, Sean A; Kaur, Jaswant; Virdee, Gursharan; George, Tony P; McKenzie, Kwame; Herman, Yarissa

2014-08-01

Cognitive remediation (CR) has demonstrated good outcomes when paired with supported employment, however little is known about its effectiveness when integrated into a supported education program. This randomized controlled trial examined the effectiveness of integrating CR within a supported education program compared with supported education without CR. Thirty-seven students with psychosis were recruited into the study in the 2012 academic year. Academic functioning, cognition, self-esteem, and symptomatology were assessed at baseline, at 4months following the first academic term in which CR was provided, and at 8months assessing maintenance of gains. The treatment group demonstrated better retention in the academic program and a trend of improvement across a range of academic functional domains. While both treatment and control groups showed improvement in cognitive measures, the outcomes were not augmented by CR training. CR was also associated with significant and sustained improvements in self esteem. Further research, investigating specific intervention components is required to clarify the mixed findings regarding the effectiveness of CR in an education setting. Copyright © 2014 Elsevier B.V. All rights reserved.

Combining Motivational and Physical Intervention Components to Promote Fall-Reducing Physical Activity Among Community-Dwelling Older Adults: A Feasibility Study.

PubMed

McMahon, Siobhan Kathleen; Wyman, Jean F; Belyea, Michael J; Shearer, Nelma; Hekler, Eric B; Fleury, Julie

2016-11-01

To assess the feasibility of a new intervention, Ready~Steady, in terms of demand, acceptability, implementation, and limited efficacy. Randomized controlled trial; repeated measures. Two rural communities in Itasca County, Minnesota. Thirty participants were randomized to an intervention (n = 16) or attention-control (n = 14) group. Ready~Steady combined two components: (1) motivational (motivational support, social network support, empowering education), and (2) fall-reducing physical activities (PAs; guidance to practice leg-strengthening, balance, and flexibility activities and walking). Acceptability questionnaire and Indices of Procedural Consistency (investigator developed), Community Health Activity Model Program for Seniors Questionnaire (confirmed with accelerometry), Short Physical Performance Battery, Perceived Environmental Support Scale, Social Support for Exercise Questionnaire, Goal Attainment Scale, Index of Readiness, and Index of Self-Regulation. Descriptive statistics and a marginal approach to repeated-measures analysis of variance, using mixed-model procedures. Attrition was 7% and mean attendance was 7.2 of 8 sessions, participants evaluated Ready~Steady as acceptable, and implementation fidelity was good. The intervention group improved significantly more than the attention-control group in PA behavior, F 1,27 = 11.92, p = .002; fall risk (functional balance and strength), F 1,27 = 14.89, p = .001; support for exercise from friends, F 1,27 = 11.44, p = .002; and self-regulation, F 1,26 = 38.82, p < .005. The Ready~Steady intervention was feasible as evidenced by low attrition and good attendance and implementation, as well as positive effects on targeted outcomes and theoretical mechanisms of change. © 2016 by American Journal of Health Promotion, Inc.

A philosophical argument against evidence-based policy.

PubMed

Anjum, Rani Lill; Mumford, Stephen D

2017-10-01

Evidence-based medicine has two components. The methodological or ontological component consists of randomized controlled trials and their systematic review. This makes use of a difference-making conception of cause. But there is also a policy component that makes a recommendation for uniform intervention, based on the evidence from randomized controlled trials. The policy side of evidence-based medicine is basically a form of rule utilitarianism. But it is then subject to an objection from Smart that rule utilitarianism inevitably collapses. If one assumes (1) you should recommend the intervention that has brought most benefit (the core of evidence-based policy making), (2) individual variation (acknowledged by use of randomization) and (3) no intervention benefits all (contingent but true), then the objection can be brought to bear. A utility maximizer should always ignore the rule in an individual case where greater benefit can be secured through doing so. In the medical case, this would mean that a clinician who knows that a patient would not benefit from the recommended intervention has good reason to ignore the recommendation. This is indeed the feeling of many clinicians who would like to offer other interventions but for an aversion to breaking clinical guidelines. © 2016 John Wiley & Sons, Ltd.

Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training.

PubMed

van Dongen, Heleen; Emanuel, Mark Hans; Wolterbeek, Ron; Trimbos, J Baptist; Jansen, Frank Willem

2008-01-01

The purpose of this randomized controlled study was to compare conventional resectoscopy and hysteroscopic morcellation among residents in training (Canadian Task Force classification I). Sixty women with an intrauterine polyp or myoma were randomized to either hysteroscopic removal by conventional resectoscopy or hysteroscopic morcellation performed by 6 residents in training for obstetrics and gynecology (10 procedures per resident). The mean operating time for resectosocpy and morcellation was 17.0 (95% confidence interval [95% CI] 14.1-17.9, standard deviation [SD] 8.4) and 10.6 (95% CI 7.3-14.0, SD 9.5) min, respectively (p = .008). Multiple linear regression analysis showed that operating time increased significantly, for both resectoscopy and morcellator, when volume of intrauterine disorder increased. The use of the hysteroscopic morcellator reduced operating time more than 8 min in comparison to conventional resectoscopy (p < .001) when correction for volume was applied. Subjective surgeon and trainer scores for convenience of technique on a visual analog scale were in favor of the morcellator. No learning curve was observed. In conclusion, the hysteroscopic morcellator for removal of intrauterine polyps and myomas offers a good alternative to conventional resectoscopy for residents in training.

Student perceptions of a good teacher: the gender perspective.

PubMed

Jules, V; Kutnick, P

1997-12-01

A large-scale survey of pupils' perceptions of a good teacher in the Caribbean republic of Trinidad and Tobago is reported. An essay-based, interpretative mode of research was used to elicit and identify constructs used by boys and girls. The study explores similarities and differences between boys and girls in their perceptions of a good teacher, in a society where girls achieve superior academic performance (than boys). A total of 1756 pupils and students aged between 8 and 16 provided the sample, which was proportional, stratified, clustered. Within these constraints classrooms were randomly selected to be representative of primary and secondary schools across the two islands. Altogether 1539 essays and 217 interviews were content analysed, coded for age development and compared between boys and girls. Content items identified by the pupils were logically grouped into: physical and personal characteristics of the teacher, quality of the relationship between the teacher and pupil, control of behaviour by the teacher, descriptions of the teaching process, and educational and other outcomes obtained by pupils due to teacher efforts. Female pupils identified more good teacher concepts at all age levels than males. There was some commonality between the sexes in concepts regarding interpersonal relationships and inclusiveness in the good teachers' teaching practices and boys showed significantly greater concerns regarding teacher control and use of punishment. Males as young as 8 years stated that good teachers should be sensitive to their needs. Only among the 16-year-old males were males noted as good teachers. Consideration is given to the roles of male and female teachers, how their classroom actions may set the basis for future success (or failure) of their pupils, and the needs of pupils with regard to teacher support within developing and developed countries.

The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial: a community-based participatory research (CBPR) trial with African-American church congregations for reducing cardiovascular disease risk factors--recruitment, measurement, and randomization.

PubMed

DeHaven, Mark J; Ramos-Roman, Maria A; Gimpel, Nora; Carson, JoAnn; DeLemos, James; Pickens, Sue; Simmons, Chris; Powell-Wiley, Tiffany; Banks-Richard, Kamakki; Shuval, Kerem; Duvahl, Julie; Duval, Julie; Tong, Liyue; Hsieh, Natalie; Lee, Jenny J

2011-09-01

Although cardiovascular diseases (CVD) are the leading cause of death among Americans, significant disparities persist in CVD prevalence, morbidity, and mortality based on race and ethnicity. However, few studies have examined risk factor reduction among the poor and ethnic minorities. Community-based participatory research (CBPR) study using a cluster randomized design--African-American church congregations are the units of randomization and individuals within the congregations are the units of analysis. Outcome variables include dietary change (Diet History Questionnaire), level of physical activity (7-Day Physical Activity Recall), lipoprotein levels, blood pressure, fasting glucose, and hemoglobin A1c. Eighteen (18) church congregations were randomized to either a health maintenance intervention or a control condition. Complete data were obtained on 392 African-American individuals, 18 to 70 years of age, predominantly employed women with more than a high school diploma. Treatment and intervention groups were similar at baseline on saturated fat intake, metabolic equivalent of tasks (METS) per day, and other risk factors for CVD. The GoodNEWS trial successfully recruited and evaluated CVD-related risk among African-American participants using a CBPR approach. Several logistical challenges resulted in extending the recruitment, preliminary training, and measurement periods. The challenges were overcome with the assistance of a local community consultant and a professional event planner. Our experience supports the need for incorporating non-traditional community-based staff into the design and operational plan of CBPR trials. Copyright © 2011 Elsevier Inc. All rights reserved.

Ultrathin Silicon Sheet in the Management of Unilateral Post-traumatic Temporo-Mandibuar Joint Ankylosis in Children: A Good Alternative to Conventional Techniques.

PubMed

Aggarwal, Sushil Kumar; Ankur, Bhatnagar; Jain, R K

2015-09-01

We have described a new technique of using ultra-thin silicon sheet (0.2 mm) between two transected bony ends for temporo-mandibular joint (TMJ) ankylosis in children with advantages of short operative time, minimal foreign material insertion and faster recovery time post-operatively which makes our technique a good alternative to conventional techniques. Our study is a non-randomized prospective study conducted on 10 children aged between 4 and 15 years who presented to our tertiary care institute with severe trismus after traumatic injury and were willing to undergo this new technique. The main outcome measure taken into consideration was difference between pre-operative, intra-operative (on table) and post-operative mouth opening (minimum 2 years follow-up). The pre-operative mouth opening in our cases varied from 1 to 5 mm. The intra-operative mouth opening achieved ranged from 2.8 to 3.2 cm. The mouth opening was about more than 2.7 cm in all our cases at 2 years of follow-up. Our technique is a good alternative to conventional techniques used for TMJ ankylosis in children but few more randomized controlled trials are required to assess its effectiveness in comparison to conventional techniques and for universal adoption of this technique.

Rotator cuff healing after needling of a calcific deposit using platelet-rich plasma augmentation: a randomized, prospective clinical trial.

PubMed

Verhaegen, Filip; Brys, Peter; Debeer, Philippe

2016-02-01

Arthroscopic needling of a rotator cuff calcification is a highly reliable operation in terms of pain relief and return of function. However, during the needling process, a cuff defect is created. Little is known about the evolution of this defect. We conducted a prospective, randomized controlled clinical trial to investigate the evolution of the aforementioned defect and the role of platelet-rich plasma (PRP) augmentation in this healing process. Patients were randomized to either group 1 (PRP, n = 20) or group 2 (no PRP [control group], n = 20). Patients in group 1 received a perioperative PRP infiltration at the rotator cuff defect, whereas the control group did not. Patients were assessed clinically preoperatively and postoperatively at 6 weeks, 3 and 6 months, and 1 year. The Constant score, Simple Shoulder Test, and QuickDASH (short version of Disabilities of the Arm, Shoulder and Hand questionnaire) were used as outcome measures. The evolution of the cuff defect was evaluated on sonography at 3 and 6 months and with magnetic resonance imaging after 1 year. All patients improved significantly after surgery (P < .05). There was no difference in clinical outcome or rotator cuff healing between groups. We observed a high rate of persistent rotator cuff defects after 1 year in both groups. The presence of residual cuff defects did not influence the clinical outcome. Arthroscopic needling is an operation with a predictive, good clinical outcome. We found a high rate of persistent rotator cuff defects after 1 year. This study could not identify any beneficial effect of the addition of PRP on rotator cuff healing. Level II; Randomized Controlled Trial; Treatment Study. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

A school-based comprehensive lifestyle intervention among chinese kids against obesity (CLICK-Obesity): rationale, design and methodology of a randomized controlled trial in Nanjing city, China.

PubMed

Xu, Fei; Ware, Robert S; Tse, Lap Ah; Wang, Zhiyong; Hong, Xin; Song, Aiju; Li, Jiequan; Wang, Youfa

2012-06-15

The prevalence of childhood obesity among adolescents has been rapidly rising in Mainland China in recent decades, especially in urban and rich areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited data regarding adolescent overweight prevention in China are available. Thus, we developed a school-based intervention with the aim of reducing excess body weight in children. This report described the study design. We designed a cluster randomized controlled trial in 8 randomly selected urban primary schools between May 2010 and December 2013. Each school was randomly assigned to either the intervention or control group (four schools in each group). Participants were the 4th graders in each participating school. The multi-component program was implemented within the intervention group, while students in the control group followed their usual health and physical education curriculum with no additional intervention program. The intervention consisted of four components: a) classroom curriculum, (including physical education and healthy diet education), b) school environment support, c) family involvement, and d) fun programs/events. The primary study outcome was body composition, and secondary outcomes were behaviour and behavioural determinants. The intervention was designed with due consideration of Chinese cultural and familial tradition, social convention, and current primary education and exam system in Mainland China. We did our best to gain good support from educational authorities, school administrators, teachers and parents, and to integrate intervention components into schools' regular academic programs. The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainland China. ChiCTR-ERC-11001819.

The Social Marketing of Safety Behaviors: A Quasi–Randomized Controlled Trial of Tractor Retrofitting Incentives

PubMed Central

Jenkins, Paul L.; Emmelin, Maria; Stenlund, Hans; Weinehall, Lars; Earle-Richardson, Giulia B.; May, John J.

2011-01-01

Objectives. We assessed the effect of social marketing incentives on dispositions toward retrofitting and retrofitting behavior among farmers whose tractors lacked rollover protective structures. Methods. From 2006 to 2007, we conducted a quasi–randomized controlled trial with 391 farm owners in New York and Pennsylvania surveyed before and after exposure to 1 of 3 tractor retrofitting incentive combinations. These combinations were offered in 3 trial regions; region 1 received rebates; region 2 received rebates, messages, and promotion and was considered the social marketing region; and region 3 received messages and promotion. A fourth region served as a control. Results. The social marketing region generated the greatest increases in readiness to retrofit, intentions to retrofit, and message recall. In addition, postintervention stage of change, intentions, attitudes, subjective norms, and perceived behavioral control levels were higher among farmers who had retrofitted tractors. Conclusions. Our results showed that a social marketing approach (financial incentives, tailored messages, and promotion) had the greatest influence on message recall, readiness to retrofit tractors, and intentions to retrofit tractors and that behavioral measures were fairly good predictors of tractor retrofitting behaviors. PMID:21330581

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

PubMed

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

1999-07-01

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

On framing the research question and choosing the appropriate research design.

PubMed

Parfrey, Patrick S; Ravani, Pietro

2015-01-01

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, to ensure adequate samples, to measure input and output variables appropriately, to consider external and internal validities, to limit bias, and to address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision-making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.

On framing the research question and choosing the appropriate research design.

PubMed

Parfrey, Patrick; Ravani, Pietro

2009-01-01

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires the definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, ensure adequate samples, measure input and output variables appropriately, consider external and internal validities, limit bias, and address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.

A randomized trial of a lay person-led self-management group intervention for back pain patients in primary care.

PubMed

Von Korff, M; Moore, J E; Lorig, K; Cherkin, D C; Saunders, K; González, V M; Laurent, D; Rutter, C; Comite, F

1998-12-01

Randomized, controlled trial. To evaluate a four-session self-management group intervention for patients with pain in primary care, led by trained lay persons with back pain. The intervention was designed to reduce patient worries, encourage self-care, and reduce activity limitations. Randomized trials of educational interventions suggest that activating interventions may improve back pain outcomes. Expert opinion increasingly regards effective self-management of back pain as important in achieving good outcomes. In this study, an educational intervention designed to activate patients and support effective self-management was evaluated. Six to 8 weeks after a primary care visit for back pain, patients were invited to participate in an educational program to improve back pain self-management. Those showing interest by returning a brief questionnaire became eligible for the study. Participants (n = 255) randomly were assigned to either a self-management group intervention or to a usual care control group. The effect of the intervention, relative to usual care, was assessed 3, 6, and 12 months after randomization, controlling for baseline values. The intervention consisted of a four-session group applying problem-solving techniques to back pain self-management, supplemented by educational materials (book and videos) supporting active management of back pain. The groups were led by lay persons trained to implement a fully structured group protocol. The control group received usual care, supplemented by a book on back pain care. Participants randomly assigned to the self-management groups reported significantly less worry about back pain and expressed more confidence in self-care. Roland Disability Questionnaire Scores were significantly lower among participants in the self-management groups relative to the usual care controls at 6 months (P = 0.007), and this difference was sustained at 12 months at borderline significance levels (P = 0.09). Among self-management group participants, 48% showed a 50% or greater reduction in Roland Disability Questionnaire Score at 6 months, compared with 33% among the usual care controls. Self-management groups led by trained lay persons following a structured protocol were more effective than usual care in reducing worries, producing positive attitudes toward self-care, and reducing activity limitations among patients with back pain in primary care.

A method for the analysis of nonlinearities in aircraft dynamic response to atmospheric turbulence

NASA Technical Reports Server (NTRS)

Sidwell, K.

1976-01-01

An analytical method is developed which combines the equivalent linearization technique for the analysis of the response of nonlinear dynamic systems with the amplitude modulated random process (Press model) for atmospheric turbulence. The method is initially applied to a bilinear spring system. The analysis of the response shows good agreement with exact results obtained by the Fokker-Planck equation. The method is then applied to an example of control-surface displacement limiting in an aircraft with a pitch-hold autopilot.

Research on the adaptive optical control technology based on DSP

NASA Astrophysics Data System (ADS)

Zhang, Xiaolu; Xue, Qiao; Zeng, Fa; Zhao, Junpu; Zheng, Kuixing; Su, Jingqin; Dai, Wanjun

2018-02-01

Adaptive optics is a real-time compensation technique using high speed support system for wavefront errors caused by atmospheric turbulence. However, the randomness and instantaneity of atmospheric changing introduce great difficulties to the design of adaptive optical systems. A large number of complex real-time operations lead to large delay, which is an insurmountable problem. To solve this problem, hardware operation and parallel processing strategy are proposed, and a high-speed adaptive optical control system based on DSP is developed. The hardware counter is used to check the system. The results show that the system can complete a closed loop control in 7.1ms, and improve the controlling bandwidth of the adaptive optical system. Using this system, the wavefront measurement and closed loop experiment are carried out, and obtain the good results.

Different clinical prognostic factors are associated with improved glycaemic control: findings from MARCH randomized trial.

PubMed

Han, J; Yu, H; Tu, Y; Pang, J; Liu, F; Bao, Y; Yang, W; Jia, W

2017-04-01

Metformin and acarbose have comparable efficacy as initial therapy for HbA 1c reduction in Chinese patients with newly diagnosed Type 2 diabetes. However, not all participants achieved glycaemic control. Our aim was to discover a monotherapy predictor for therapeutic response in Type 2 diabetes on the basis of baseline features. Data from the MARCH trial were collected, resulting in 698 individuals being available for longitudinal analyses. All participants were divided into subgroups based on successful and unsuccessful achievement of the glycaemic target according to primary endpoints at week 24 (HbA 1c < 53 mmol/mol; 7.0%). Logistic regression analysis with stepwise variable selection was performed to assess the independent risk factors for good glycaemic control of monotherapy with metformin or acarbose. Median HbA 1c was 66 ± 1 mmol/mol (8.2 ± 0.07%) in the metformin group at baseline, and 66 ± 1 mmol/mol (8.2 ± 0.07%) in the acarbose group. After 24 weeks of monotherapy, 79.8% of participants in the metformin group achieved glycaemic targets compared with 78.7% of those in the acarbose group. Multivariate regression analysis showed that BMI and fasting blood glucose were significant independent predictors for the maintenance of good glycaemic control in the metformin group, whereas phase I insulin secretion (Insulin/Glucose at 30 min, I30/G30) and duration of diabetes were associated with good glycaemic control in the acarbose group. For newly diagnosed Type 2 diabetes, some clinical features and laboratory parameters are important prognostic factors for predicting drug responsiveness. Participants with a higher BMI and lower fasting blood glucose achieved good glycaemic control when metformin was selected as the initial treatment. Acarbose was best for participants with higher phase I insulin secretion (I30/G30) and shorter duration of Type 2 diabetes. © 2016 Diabetes UK.

HIV Interventions to Reduce HIV/AIDS Stigma: A Systematic Review

PubMed Central

Banks, Bahby; Jonas, Dan; Miles, Margaret Shandor; Smith, Giselle Corbie

2011-01-01

We reviewed the literature to determine the effectiveness of HIV-related interventions in reducing HIV/AIDS stigma. Studies selected had randomized controlled trial (RCT), pretest–posttest with a non-randomized control group, or pretest–posttest one group study designs in which HIV-related interventions were being evaluated, and in which HIV/AIDS stigma was one of the outcomes being measured. A checklist was used to extract data from accepted studies, assess their internal validity, and overall quality. Data were extracted from 19 studies, and 14 of these studies demonstrated effectiveness in reducing HIV/ AIDS stigma. Only 2 of these 14 effective studies were considered good studies, based on quality, the extent to which the intervention focused on reducing HIV/AIDS stigma, and the statistics reported to demonstrate effectiveness. Future studies to reduce HIV/AIDS stigma could improve by designing interventions that pay greater attention to internal validity, use validated HIV/AIDS stigma instruments, and achieve both statistical and public health significance. PMID:21088989

Upper Extremity Muscle Volumes and Functional Strength After Resistance Training in Older Adults

PubMed Central

Daly, Melissa; Vidt, Meghan E.; Eggebeen, Joel D.; Simpson, W. Greg; Miller, Michael E.; Marsh, Anthony P.; Saul, Katherine R.

2014-01-01

Aging leads to a decline in strength and an associated loss of independence. The authors examined changes in muscle volume, maximum isometric joint moment, functional strength, and 1-repetition maximum (1RM) after resistance training (RT) in the upper extremity of older adults. They evaluated isometric joint moment and muscle volume as predictors of functional strength. Sixteen healthy older adults (average age 75 ± 4.3 yr) were randomized to a 6-wk upper extremity RT program or control group. The RT group increased 1RM significantly (p < .01 for all exercises). Compared with controls, randomization to RT led to greater functional pulling strength (p = .003), isometric shoulder-adduction moment (p = .041), elbow-flexor volume (p = .017), and shoulder-adductor volume (p = .009). Shoulder-muscle volumes and isometric moments were good predictors of functional strength. The authors conclude that shoulder strength is an important factor for performing functional reaching and pulling tasks and a key target for upper extremity RT interventions. PMID:22952203

HIV interventions to reduce HIV/AIDS stigma: a systematic review.

PubMed

Sengupta, Sohini; Banks, Bahby; Jonas, Dan; Miles, Margaret Shandor; Smith, Giselle Corbie

2011-08-01

We reviewed the literature to determine the effectiveness of HIV-related interventions in reducing HIV/AIDS stigma. Studies selected had randomized controlled trial (RCT), pretest-posttest with a non-randomized control group, or pretest-posttest one group study designs in which HIV-related interventions were being evaluated, and in which HIV/AIDS stigma was one of the outcomes being measured. A checklist was used to extract data from accepted studies, assess their internal validity, and overall quality. Data were extracted from 19 studies, and 14 of these studies demonstrated effectiveness in reducing HIV/AIDS stigma. Only 2 of these 14 effective studies were considered good studies, based on quality, the extent to which the intervention focused on reducing HIV/AIDS stigma, and the statistics reported to demonstrate effectiveness. Future studies to reduce HIV/AIDS stigma could improve by designing interventions that pay greater attention to internal validity, use validated HIV/AIDS stigma instruments, and achieve both statistical and public health significance.

Long-term follow-up of a randomized study of support group intervention in women with primary breast cancer.

PubMed

Björneklett, Helena Granstam; Rosenblad, Andreas; Lindemalm, Christina; Ojutkangas, Marja-Leena; Letocha, Henry; Strang, Peter; Bergkvist, Leif

2013-04-01

Despite a fairly good prognosis, many breast-cancer patients suffer from symptoms such as anxiety, depression and fatigue, which may affect health-related quality of life and may persist for several years. The aim of the present study was to perform a long-term follow-up of a randomized study of support group intervention in women after primary breast cancer treatment. Three hundred and eighty two women with primary breast cancer were randomized to support group intervention or control group, 181 in each group. Women in the intervention group participated in 1 week of intervention followed by 4 days of follow-up 2 months later. This is a long-term follow-up undertaken, in average, 6.5 years after randomization. Patients answered the questionnaires the European Organisation for Research and Treatment of Cancer, quality of life questionnaire (EORTC QLQ-C30) and the breast cancer module questionnaire (BR 23), the hospital anxiety and depression scale (HAD) and the Norwegian version of the fatigue scale (FQ). After adjusting for treatment with chemotherapy, age, marriage, education and children at home, there was a significant improvement in physical, mental and total fatigue (FQ), cognitive function, body image and future perspective (EORTC QLQ C30 and BR23) in the intervention group compared with controls. The proportion of women affected by high anxiety and depression scores were not significantly different between the groups. Support intervention significantly improved cognitive function, body image, future perspective and fatigue, compared with to the findings in the control group. Copyright © 2012 Elsevier Inc. All rights reserved.

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.

PubMed

Gareb, B; van Bakelen, N B; Buijs, G J; Jansma, J; de Visscher, J G A M; Hoppenreijs, Th J M; Bergsma, J E; van Minnen, B; Stegenga, B; Bos, R R M

2017-01-01

Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation. The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery. The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS). After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups. In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures. http://controlled-trials.com ISRCTN44212338.

Spend today, clean tomorrow: Predicting methamphetamine abstinence in a randomized controlled trial

PubMed Central

Murtaugh, Kimberly Ling; Krishnamurti, Tamar; Davis, Alexander L.; Reback, Cathy J.; Shoptaw, Steven

2013-01-01

Objective This secondary analysis of data from a randomized controlled trial tested two behavioral economics mechanisms (substitutability and delay discounting) to explain outcomes using contingency management (CM) for methamphetamine dependence. Frequency and purchase type (hedonic/utilitarian and consumable/durable) of CM payments were also examined. Methods 82 methamphetamine-dependent gay/bisexual men randomly assigned to conditions delivering CM received monetary vouchers in exchange for stimulant-negative urine samples in a 16-week trial requiring thrice weekly visits (Shoptaw et al., 2005). At any visit participants could redeem vouchers for goods. A time-lagged counting process Cox Proportional Hazards model for recurrent event survival analysis examined aspects of the frequency and type of these CM purchases. Results After controlling for severity of baseline methamphetamine use and accumulated CM wealth, as measured by cumulative successful earning days, participants who redeemed CM earnings at any visit (“spenders”) were significantly more likely to produce stimulant-negative urine samples in the subsequent visit, compared to those who did not redeem (“savers”) 1.011* [1.005, 1.017], Z=3.43, p<0.001. Conclusions Findings support the economic concept of substitutability of CM purchases and explain trial outcomes as a function of frequency of CM purchases rather than frequency or accumulated total CM earnings. Promotion of frequent purchases in incentive-based programs should facilitate substitution for the perceived value of methamphetamine and improve abstinence outcomes. PMID:24001246

Narcolepsy: current treatment options and future approaches

PubMed Central

Billiard, Michel

2008-01-01

The management of narcolepsy is presently at a turning point. Three main avenues are considered in this review: 1) Two tendencies characterize the conventional treatment of narcolepsy. Modafinil has replaced methylphenidate and amphetamine as the first-line treatment of excessive daytime sleepiness (EDS) and sleep attacks, based on randomized, double blind, placebo-controlled clinical trials of modafinil, but on no direct comparison of modafinil versus traditional stimulants. For cataplexy, sleep paralysis, and hypnagogic hallucinations, new antidepressants tend to replace tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs) in spite of a lack of randomized, double blind, placebo-controlled clinical trials of these compounds; 2) The conventional treatment of narcolepsy is now challenged by sodium oxybate, the sodium salt of gammahydroxybutyrate, based on a series of randomized, double-blind, placebo-controlled clinical trials and a long-term open label study. This treatment has a fairly good efficacy and is active on all symptoms of narcolepsy. Careful titration up to an adequate level is essential both to obtain positive results and avoid adverse effects; 3) A series of new treatments are currently being tested, either in animal models or in humans, They include novel stimulant and anticataplectic drugs, endocrine therapy, and, more attractively, totally new approaches based on the present state of knowledge of the pathophysiology of narcolepsy with cataplexy, hypocretine-based therapies, and immunotherapy. PMID:18830438

Phenotypic differences between male physicians, surgeons, and film stars: comparative study.

PubMed

Trilla, Antoni; Aymerich, Marta; Lacy, Antonio M; Bertran, Maria J

2006-12-23

To test the hypothesis that, on average, male surgeons are taller and better looking than male physicians, and to compare both sets of doctors with film stars who play doctors on screen. Comparative study. Typical university hospital in Spain, located in Barcelona and not in a sleepy backwater. Random sample of 12 surgeons and 12 physicians plus 4 external controls (film stars who play doctors), matched by age (50s) and sex (all male). An independent committee (all female) evaluated the "good looking score" (range 1-7). Height (cm) and points on the good looking score. Surgeons were significantly taller than physicians (mean height 179.4 v 172.6 cm; P=0.01). Controls had significantly higher good looking scores than surgeons (mean score 5.96 v 4.39; difference between means 1.57, 95% confidence interval 0.69 to 2.45; P=0.013) and physicians (5.96 v 3.65; 2.31, 1.58 to 3.04; P=0.003). Surgeons had significantly higher good looking scores than physicians (4.39 v 3.65; 0.74; 0.25 to 1.23; P=0.010). Male surgeons are taller and better looking than physicians, but film stars who play doctors on screen are better looking than both these groups of doctors. Whether these phenotypic differences are genetic or environmental is unclear.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial.

PubMed

Rowe, Sarah L; Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-30

Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG). ©Sarah L Rowe, Krisna Patel, Rebecca S French, Claire Henderson, Dennis Ougrin, Mike Slade, Paul Moran. Originally published in JMIR Mental Health (http://mental.jmir.org), 30.01.2018.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial

PubMed Central

Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-01

Background Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. Objective The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. Methods We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Results Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. Conclusions A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. Trial Registration International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG) PMID:29382626

Effectiveness and efficiency of the two trolley system as an infection control mechanism in the operating theatre.

PubMed

Tuisawana, Viliame

2009-11-01

A good infection control manager understands the need to prevent a complete cycle of infection. The Infection Control Working Group Manual of Fiji, emphasised that the Cycle of Infection is the series of stage in which infection is spread. Operating theatres have infection control protocols. Most equipments and instruments used in operating theatre circulate within the theatre. The theatre trolleys are a main component in managing an operating theatre but the least recognised. This paper reviews the effectiveness and efficiency of the current two-trolley system as an infection control mechanism in theatre. The paper will discuss infection control using the current trolley system in relation to the layout of Labasa Hospital operating theatre, human resource, equipment standard and random swab results. The following are random swab results of theatre equipments taken by the Infection Control Nurse from 2006 to 2008. The Labasa Hospital Infection Committee have discouraged random swab sample from mid 2008 based on new guidelines on infection control. The two trolley system, in which an allocated outside trolley transports patients from the ward to a semi-sterile area in theatre. The inside trolley which transports the patient to the operating table. The two trolley system means more trolleys, extra staffs for lifting, additional handling of very sick patients, congestion and delay in taking patients to operating table in theatres should be considered. The one-trolley system in theatre greatly reduces the chances of manually lifting patients, thus reducing the risk of patient injury from fall and risk of back injuries to nurses. There are other evident based practices which can compliment the one trolley system for an effective infection control mechanism in theatres. The Fiji Infection Control Manual (2002) emphases the importance of regularly cleaning the environment and equipments in theatre but there is never a mention about using a two trolley system as an infection control mechanism for theatre.

Anatomical and functional evaluation of tympanoplasty using a transitory natural latex biomembrane implant from the rubber tree Hevea brasiliensis.

PubMed

Araujo, Marcos Miranda; Massuda, Eduardo Tanaka; Hyppolito, Miguel Angelo

2012-08-01

To compare the role of transitory latex and sylastic® implants in tympanoplasty on the closure of tympanic perforations. A randomized double-blind prospective study was conducted on 107 patients with chronic otitis media submitted to underlay tympanoplasty and divided at random into three groups: control with no transitory implant, latex membrane group, and sylastic® membrane group. Greater graft vascularization occurred in the latex membrane group (p<0.05). Good biocompatibility was obtained with the use of the latex and silicone implants, with no effect on the occurrence of infection, otorrhea or otorragy. The use of a transitory latex implant induced greater graft vascularization, with a biocompatible interaction with the tissue of the human tympanic membrane.

Research: Treatment Study to determine the durability of glycaemic control with early treatment with a vildagliptin–metformin combination regimen vs. standard-of-care metformin monotherapy—the VERIFY trial: a randomized double-blind trial

PubMed Central

Del Prato, S; Foley, J E; Kothny, W; Kozlovski, P; Stumvoll, M; Paldánius, P M; Matthews, D R

2014-01-01

Aims Durability of good glycaemic control (HbA1c) is of importance as it can be the foundation for delaying diabetic complications. It has been hypothesized that early initiation of treatment with the combination of oral anti-diabetes agents with complementary mechanisms of action can increase the durability of glycaemic control compared with metformin monotherapy followed by a stepwise addition of oral agents. Dipeptidyl peptidase-4 inhibitors are good candidates for early use as they are efficacious in combination with metformin, show weight neutrality and a low risk of hypoglycaemia. We aimed to test the hypothesis that early combined treatment of metformin and vildagliptin slows β-cell deterioration as measured by HbA1c. Methods Approximately 2000 people with Type 2 diabetes mellitus who were drug-naive or who were treated with metformin for less than 1 month, and who have HbA1c of 48–58 mmol/mol (6.5–7.5%), will be randomized in a 1:1 ratio in VERIFY, a 5-year multinational, double-blind, parallel-group study designed to compare early initiation of a vildagliptin–metformin combination with standard-of-care initiation of metformin monotherapy, followed by the stepwise addition of vildagliptin when glycaemia deteriorates. Further deterioration will be treated with insulin. The primary analysis for treatment failure will be from a Cox proportional hazard regression model and the durability of glycaemic control will be evaluated by assessing treatment failure rate and the rate of loss in glycaemic control over time as co-primary endpoints. Summary VERIFY is the first study to investigate the long-term clinical benefits of early combination treatment vs. the standard-of-care metformin monotherapy with a second agent added by threshold criteria. PMID:24863949

Novel incentives and messaging in an online college smoking intervention.

PubMed

Berg, Carla J; Stratton, Erin; Sokol, Michael; Santamaria, Andrew; Bryant, Lawrence; Rodriguez, Rolando

2014-09-01

To examine the feasibility, acceptability, and potential effectiveness of an online intervention targeting college smokers. The incentives involved discounted or free goods and services from businesses proximal to each campus. A randomized controlled trial was conducted with 122 current smokers recruited from 2 Southeastern US universities. The intervention involved health behavior monitoring, targeted messaging, and incentives for healthy goods and services versus the American Cancer Society's Guide to Quitting Smoking online. The intervention achieved greater adherence and utilization (p's < .001). Overall, 55.6% learned about a local business through this program. At end-of-treatment, intervention participants less frequently attempted to quit (p = .02) but smoked fewer cigarettes/day (p = .05). Both groups demonstrated significant end-of-treatment cessation rates. This intervention demonstrated feasibility and acceptability.

Loupe magnification for small incision cataract surgery--an alternative to microscope magnification?

PubMed

Singh, S K; Winter, I; Hennig, A

2008-01-01

A Prospective randomized controlled study was conducted to compare outcome of Small Incision Cataract Surgery (SICS) using microscope or loupe magnification. Two hundred fifty one patient with mature cataract were randomly allocated to SICS-Fishhook Technique with either microscope (127 eyes) or loupe (124 eyes) magnification. Intra- and postoperative complications and immediate visual outcome were analyzed. Nearly two third (microscope 65% and magnifying loupe 62.9%) of all patients had good visual outcome on first postoperative day. Poor outcome (<6/60) was recorded in 8% (microscope group) and 7% (magnifying loupe group). Mean visual acuity with Snellen was 0.39 (SD 0.2) in microscope group and 0.38 (SD 0.2) in magnifying loupe group. Intra operative complications were comparable in both groups. Mean surgery time with loupe magnification was significantly shorter. Comparatively equivalent good surgical outcome was achieved with loupe as well as with microscope magnification. However performing SICS with loupe magnification is significantly faster. Small incision cataract surgery with loupe magnification is safe and effective procedure for cataract surgery so it can play a role in reducing cataract blindness in developing countries of the world.

Synthesis of hover autopilots for rotary-wing VTOL aircraft

NASA Technical Reports Server (NTRS)

Hall, W. E.; Bryson, A. E., Jr.

1972-01-01

The practical situation is considered where imperfect information on only a few rotor and fuselage state variables is available. Filters are designed to estimate all the state variables from noisy measurements of fuselage pitch/roll angles and from noisy measurements of both fuselage and rotor pitch/roll angles. The mean square response of the vehicle to a very gusty, random wind is computed using various filter/controllers and is found to be quite satisfactory although, of course, not so good as when one has perfect information (idealized case). The second part of the report considers precision hover over a point on the ground. A vehicle model without rotor dynamics is used and feedback signals in position and integral of position error are added. The mean square response of the vehicle to a very gusty, random wind is computed, assuming perfect information feedback, and is found to be excellent. The integral error feedback gives zero position error for a steady wind, and smaller position error for a random wind.

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

PubMed

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

2017-11-01

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

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

PubMed Central

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

2017-01-01

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

Social adjustment and competence 35 years after onset of childhood epilepsy: a prospective controlled study.

PubMed

Jalava, M; Sillanpää, M; Camfield, C; Camfield, P

1997-06-01

To study the effect of childhood-onset epilepsy without other neurologic deficit on adult social adjustment and competence. Social competence was studied in a prospective, population-based cohort of childhood-onset epilepsy after a mean follow-up of 35 years. One hundred patients (60% of the total cohort) had no other neurologic problems ("epilepsy only"), and for each patient, two matched controls, a "random" control and an "employee" control were chosen. Good social outcome was significantly reduced in the "epilepsy only" cohort compared with random controls: education [cumulative odds ratio (COR), 2.4; 95% confidence interval (CI), 1.4-4.1]; employability (COR, 7.3; 95% CI, 2.7-20.0); and marriage rate (COR, 3.7; 95% CI, 1.9-7.3). The patients with epilepsy rated their own ability to control their lives as "poor or missing" four times more frequently than the employee controls. Patients receiving antiepileptic polytherapy, but not monotherapy, were significantly less satisfied with their present life (OR, 6.7; 95% CI, 1.9-24.1) and felt their general health was significantly poorer (OR, 5.1; 95% CI, 1.2-21.3) than did the employee controls. Furthermore, patients with continuing seizures were significantly less satisfied with their present life (OR, 4.1; 95% CI, 1.1-15.1) than were employee controls. Many patients with "epilepsy only" beginning in childhood have persistent and significant social-adjustment and competence problems in adulthood.

A Monte Carlo analysis of breast screening randomized trials.

PubMed

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

2016-12-01

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

A health economic outcome evaluation of an internet-based mobile-supported stress management intervention for employees.

PubMed

Ebert, David Daniel; Kählke, Fanny; Buntrock, Claudia; Berking, Matthias; Smit, Filip; Heber, Elena; Baumeister, Harald; Funk, Burkhardt; Riper, Heleen; Lehr, Dirk

2018-03-01

Objective This study aimed to estimate and evaluate the cost-effectiveness and cost-benefit of a guided internet- and mobile-supported occupational stress-management intervention (iSMI) for employees from the employer's perspective alongside a randomized controlled trial. Methods A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was randomly assigned either to the iSMI or a waitlist control (WLC) group with unrestricted access to treatment as usual. The iSMI consisted of seven sessions of problem-solving and emotion-regulation techniques and one booster session. Self-report data on symptoms of perceived stress and economic data were assessed at baseline, and at six months following randomization. A cost-benefit analysis (CBA) and a cost-effectiveness analysis (CEA) with symptom-free status as the main outcome from the employer's perspective was carried out. Statistical uncertainty was estimated using bootstrapping (N=5000). Results The CBA yielded a net-benefit of EUR181 [95% confidence interval (CI) -6043-1042] per participant within the first six months following randomization. CEA showed that at a willingness-to-pay ceiling of EUR0, EUR1000, EUR2000 for one additional symptom free employee yielded a 67%, 90%, and 98% probability, respectively, of the intervention being cost-effective compared to the WLC. Conclusion The iSMI was cost-effective when compared to WLC and even lead to cost savings within the first six months after randomization. Offering stress-management interventions can present good value for money in occupational healthcare.

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.

A large-scale cluster randomized trial to determine the effects of community-based dietary sodium reduction--the China Rural Health Initiative Sodium Reduction Study.

PubMed

Li, Nicole; Yan, Lijing L; Niu, Wenyi; Labarthe, Darwin; Feng, Xiangxian; Shi, Jingpu; Zhang, Jianxin; Zhang, Ruijuan; Zhang, Yuhong; Chu, Hongling; Neiman, Andrea; Engelgau, Michael; Elliott, Paul; Wu, Yangfeng; Neal, Bruce

2013-11-01

Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health. This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24-hour urine. The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups. The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide. © 2013.

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials

PubMed Central

Yuan, Jing; Liu, Fenghua

2017-01-01

Objective The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Methods Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Results Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94–1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06–1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80–1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Conclusions Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use. PMID:28570713

Patient satisfaction with wait times at an emergency ophthalmology on-call service.

PubMed

Chan, Brian J; Barbosa, Joshua; Moinul, Prima; Sivachandran, Nirojini; Donaldson, Laura; Zhao, Lily; Mullen, Sarah J; McLaughlin, Christopher R; Chaudhary, Varun

2018-04-01

To assess patient satisfaction with emergency ophthalmology care and determine the effect provision of anticipated appointment wait time has on scores. Single-centre, randomized control trial. Fifty patients triaged at the Hamilton Regional Eye Institute (HREI) from November 2015 to July 2016. Fifty patients triaged for next-day appointments at the HREI were randomly assigned to receive standard-of-care preappointment information or standard-of-care information in addition to an estimated appointment wait time. Patient satisfaction with care was assessed postvisit using the modified Judgements of Hospital Quality Questionnaire (JHQQ). In determining how informing patients of typical wait times influenced satisfaction, the Mann-Whitney U test was performed. As secondary study outcomes, we sought to determine patient satisfaction with the intervention material using the Fisher exact test and the effect that wait time, age, sex, education, mobility, and number of health care providers seen had on satisfaction scores using logistic regression analysis. The median JHQQ response was "very good" (4/5) and between "very good" and "excellent" (4.5/5) in the intervention and control arms, respectively. There was no difference in patient satisfaction between the cohorts (Mann-Whitney U = 297.00, p = 0.964). Logistic regression analysis demonstrated that wait times influenced patient satisfaction (OR = 0.919, 95% CI 0.864-0.978, p = 0.008). Of the intervention arm patients, 92.0% (N = 23) found the preappointment information useful, whereas only 12.5% (N = 3) of the control cohort patients noted the same (p < 0.001). Provision of anticipated wait time information to patients in an emergency on-call ophthalmology clinic did not influence satisfaction with care as captured by the JHQQ. Copyright © 2018 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Socioeconomic factors and effect of evidence-based patient information about primary prevention of type 2 diabetes mellitus--are there interactions?

PubMed

Genz, Jutta; Haastert, Burkhard; Müller, Hardy; Verheyen, Frank; Cole, Dennis; Rathmann, Wolfgang; Nowotny, Bettina; Roden, Michael; Giani, Guido; Ohmann, Christian; Icks, Andrea

2014-08-18

Having shown in a recent randomized controlled trial that evidence-based patient information (EBPI) significantly increased knowledge on primary prevention of diabetes compared to standard patient information, we now investigated interaction between socioeconomic status (SES) and the effect of an EBPI. 1,120 visitors (aged 40-70 years, without known diabetes) to the "Techniker Krankenkasse" and the "German Diabetes Center" websites were randomized. The intervention group received a newly developed on-line EBPI, the control group standard on-line information. The primary outcome measure was knowledge, classified as "good/average/poor". We analyzed associations of knowledge with socioeconomic variables (education, vocational training, employment, subjective social status) combined with intervention effect including interactions, adjusted for possible confounding by knowledge before intervention, self-reported blood glucose measurements, blood pressure, blood lipid levels, age and gender. Logistic regression models were fitted to the subpopulation (n = 647) with complete values in these variables.Education (high vs. low) was significantly associated with knowledge (good vs. average/poor); however, there was no significant interaction between education and intervention. After adjustment, the other socioeconomic variables were not significantly associated with knowledge. Socioeconomic variables did not significantly change the effect of the intervention. There was a tendency towards a lower effect where lower educated individuals were concerned. Possibly the power was too low to detect interaction effects. Larger studies using SES-specific designs are needed to clarify the effect of SES. We suggest considering the socioeconomic status when evaluating a decision aid, e.g. an EBPI, to ensure its effectiveness not only in higher socioeconomic groups. Current Controlled Trials ISRCTN22060616 (Date assigned: 12 September 2008).

Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial

PubMed Central

Laviano, Alessandro; Lonnqvist, Fredrik; Muscaritoli, Maurizio; Öhlander, Maria; Schols, Annemie

2017-01-01

Abstract Background Cachectic patients with chronic obstructive pulmonary disease (COPD) may benefit from nutritional support. This double‐blind, randomized, controlled trial evaluated the safety and efficacy of targeted medical nutrition (TMN) vs. an isocaloric comparator in pre‐cachectic and cachectic patients with COPD. Methods Patients aged ≥50 years with moderate‐to‐severe COPD and involuntary weight loss or low body mass index (16–18 kg/m2) were randomized 1:1 to receive TMN (~230 kcal; 2 g omega‐3 fatty acids; 10 μg 25‐hydroxy‐vitamin D3) or isocaloric comparator twice daily for 12 weeks (ClinicalTrials.gov Identifier: NCT02442908). Primary safety endpoints comprised adverse events and changes in vital signs, laboratory parameters, and concomitant medications. Secondary efficacy endpoints included changes in weight, body composition, exercise tolerance, metabolic biomarkers, and systemic inflammation. Results Forty‐five patients were randomized to receive TMN (n = 22; mean 69.2 years) or isocaloric comparator (n = 23; mean 69.7 years). TMN was well tolerated. Adverse events were similar in number and type in both groups. Compliance to both products was good (TMN, 79%; comparator, 77%). Both groups gained weight, but the TMN group gained comparatively more fat mass (P = 0.0013). Reductions in systolic blood pressure (P = 0.0418) and secondary endpoints of triglycerides (P = 0.0217) and exercise‐induced fatigue (P = 0.0223) and dyspnoea (P = 0.0382), and increases in high‐density lipoprotein cholesterol (P = 0.0254), were observed in the TMN vs. the comparator group by week 12. Conclusions Targeted medical nutrition containing high‐dose omega‐3 fatty acids, vitamin D, and high‐quality protein is well tolerated with a good safety profile and has positive effects on blood pressure and blood lipids and on exercise‐induced fatigue and dyspnoea. Therefore, this TMN could be clinically beneficial in the nutritional and metabolic support of pre‐cachectic and cachectic patients with COPD. PMID:28891198

Targeted medical nutrition for cachexia in chronic obstructive pulmonary disease: a randomized, controlled trial.

PubMed

Calder, Philip C; Laviano, Alessandro; Lonnqvist, Fredrik; Muscaritoli, Maurizio; Öhlander, Maria; Schols, Annemie

2018-02-01

Cachectic patients with chronic obstructive pulmonary disease (COPD) may benefit from nutritional support. This double-blind, randomized, controlled trial evaluated the safety and efficacy of targeted medical nutrition (TMN) vs. an isocaloric comparator in pre-cachectic and cachectic patients with COPD. Patients aged ≥50 years with moderate-to-severe COPD and involuntary weight loss or low body mass index (16-18 kg/m 2 ) were randomized 1:1 to receive TMN (~230 kcal; 2 g omega-3 fatty acids; 10 μg 25-hydroxy-vitamin D3) or isocaloric comparator twice daily for 12 weeks (ClinicalTrials.gov Identifier: NCT02442908). Primary safety endpoints comprised adverse events and changes in vital signs, laboratory parameters, and concomitant medications. Secondary efficacy endpoints included changes in weight, body composition, exercise tolerance, metabolic biomarkers, and systemic inflammation. Forty-five patients were randomized to receive TMN (n = 22; mean 69.2 years) or isocaloric comparator (n = 23; mean 69.7 years). TMN was well tolerated. Adverse events were similar in number and type in both groups. Compliance to both products was good (TMN, 79%; comparator, 77%). Both groups gained weight, but the TMN group gained comparatively more fat mass (P = 0.0013). Reductions in systolic blood pressure (P = 0.0418) and secondary endpoints of triglycerides (P = 0.0217) and exercise-induced fatigue (P = 0.0223) and dyspnoea (P = 0.0382), and increases in high-density lipoprotein cholesterol (P = 0.0254), were observed in the TMN vs. the comparator group by week 12. Targeted medical nutrition containing high-dose omega-3 fatty acids, vitamin D, and high-quality protein is well tolerated with a good safety profile and has positive effects on blood pressure and blood lipids and on exercise-induced fatigue and dyspnoea. Therefore, this TMN could be clinically beneficial in the nutritional and metabolic support of pre-cachectic and cachectic patients with COPD. © 2017 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of the Society on Sarcopenia, Cachexia and Wasting Disorders.

Intake of potassium- and magnesium-enriched salt improves functional outcome after stroke: a randomized, multicenter, double-blind controlled trial.

PubMed

Pan, Wen-Harn; Lai, Ying-Ho; Yeh, Wen-Ting; Chen, Jiunn-Rong; Jeng, Jiann-Shing; Bai, Chyi-Huey; Lin, Ruey-Tay; Lee, Tsong-Hai; Chang, Ku-Chou; Lin, Huey-Juan; Hsiao, Chin-Fu; Chern, Chang-Ming; Lien, Li-Ming; Liu, Chung-Hsiang; Chen, Wei-Hung; Chang, Anna

2017-11-01

Background: Stroke is one of the leading causes of mortality and neurologic deficits. Management measures to improve neurologic outcomes are in great need. Our previous intervention trial in elderly subjects successfully used salt as a carrier for potassium, demonstrating a 41% reduction in cardiovascular mortality by switching to potassium-enriched salt. Dietary magnesium has been associated with lowered diabetes and/or stroke risk in humans and with neuroprotection in animals. Objective: Because a large proportion of Taiwanese individuals are in marginal deficiency states for potassium and for magnesium and salt is a good carrier for minerals, it is justifiable to study whether further enriching salt with magnesium at an amount near the Dietary Reference Intake (DRI) amount may provide additional benefit for stroke recovery. Design: This was a double-blind, randomized controlled trial comprising 291 discharged stroke patients with modified Rankin scale (mRS) ≤4. There were 3 arms: 1 ) regular salt (Na salt) ( n = 99), 2 ) potassium-enriched salt (K salt) ( n = 97), and 3 ) potassium- and magnesium-enriched salt (K/Mg salt) ( n = 95). The NIH Stroke Scale (NIHSS), Barthel Index (BI), and mRS were evaluated at discharge, at 3 mo, and at 6 mo. A good neurologic performance was defined by NIHSS = 0, BI = 100, and mRS ≤1. Results: After the 6-mo intervention, the proportion of patients with good neurologic performance increased in a greater magnitude in the K/Mg salt group than in the K salt group and the Na salt group, in that order. The K/Mg salt group had a significantly increased OR (2.25; 95% CI: 1.09, 4.67) of achieving good neurologic performance compared with the Na salt group. But the effect of K salt alone (OR: 1.58; 95% CI: 0.77, 3.22) was not significant. Conclusions: This study suggests that providing the DRI amount of magnesium and potassium together long term is beneficial for stroke patient recovery from neurologic deficits. This trial was registered at clinicaltrials.gov as NCT02910427. © 2017 American Society for Nutrition.

New lidocaine lozenge as topical anesthesia compared to lidocaine viscous oral solution before upper gastrointestinal endoscopy

PubMed Central

Mogensen, Stine; Treldal, Charlotte; Feldager, Erik; Pulis, Sylvia; Jacobsen, Jette; Andersen, Ove; Rasmussen, Mette

2012-01-01

Objective To evaluate the effect and acceptance of a new lidocaine lozenge compared with a lidocaine viscous oral solution as a pharyngeal anesthetic before upper gastrointestinal endoscopy (UGE), a diagnostic procedure commonly performed worldwide during which many patients experience severe discomfort mostly because of the gag reflex. Participants The single-blinded, randomized, controlled study involved 110 adult patients undergoing diagnostic UGE at the Department of Gastroenterology, Hvidovre University Hospital, Denmark. Methods The patients were randomized to receive either 100 mg lidocaine as a lozenge or 5 mL lidocaine viscous oral solution 2%. Intravenous midazolam was administered if needed. The effect of a lidocaine lozenge in reducing patient discomfort, including the gag reflex, during UGE compared with a lidocaine oral solution was assessed. Results Questionnaires from the patients showed that the gag reflex was acceptable for 64% in the lozenge group compared with 33% in the oral solution group (P = 0.0072). UGE was evaluated as acceptable by 69% in the lozenge group compared with 39% in the oral solution group (P = 0.0092). The taste was evaluated as good by 78% in the lozenge group (P < 0.0001), and 82% found the lozenge to have good texture (P < 0.0001). Conclusion The lozenge reduced the gag reflex, diminished patients’ discomfort during UGE, and was evaluated as having a good taste and texture. The lozenge improved patients’ acceptance of UGE. PMID:22915898

[Interrater-reliability of the OPD-CA, the axes conflict and structure].

PubMed

Stefini, Annette; Reich, Günter; Horn, Hildegard; Winkelmann, Klaus; Ohmes, Ursula; Frost, Ulrike; Kronmüller, Klaus-Thomas

2013-01-01

The reliability of the meanwhile widely used Operationalized Psychodynamic Diagnostics in childhood and adolescence (OPD-CA) is only rarely examined. By means of audiovisual recordings of OPD-CA-interviews with 39 adolescents in the context of a randomized-controlled psychotherapy study for the treatment female adolescents with bulimia nervosa and atypical bulimia nervosa the reliability of the axis conflict and the axis structure were examined. This was carried out by the calculation of Intraklassen-correlations of three raters. The rater agreements ranged from good to excellent, except for impulse control in the axis structure, where the results were satisfactory. The relevance of the results for clinical practice is discussed.

Understanding health economic analysis in critical care: insights from recent randomized controlled trials.

PubMed

Sud, Sachin; Cuthbertson, Brian H

2011-10-01

The article reviews the methods of health economic analysis (HEA) in clinical trials of critically ill patients. Emphasis is placed on the usefulness of HEA in the context of positive and 'no effect' studies, with recent examples. The need to control costs and promote effective spending in caring for the critically ill has garnered considerable attention due to the high cost of critical illness. Many clinical trials focus on short-term mortality, ignoring costs and quality of life, and fail to change clinical practice or promote efficient use of resources. Incorporating HEA into clinical trials is a possible solution. Such studies have shown some interventions, although expensive, provide good value, whereas others should be withdrawn from clinical practice. Incorporating HEA into randomized controlled trials (RCTs) requires careful attention to collect all relevant costs. Decision trees, modeling assumptions and methods for collecting costs and measuring outcomes should be planned and published beforehand to minimize bias. Costs and cost-effectiveness are potentially useful outcomes in RCTs of critically ill patients. Future RCTs should incorporate parallel HEA to provide both economic outcomes, which are important to the community, alongside patient-centered outcomes, which are important to individuals.

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

PubMed Central

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

2009-01-01

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

Electroforming free controlled bipolar resistive switching in Al/CoFe2O4/FTO device with self-compliance effect

NASA Astrophysics Data System (ADS)

Munjal, Sandeep; Khare, Neeraj

2018-02-01

Controlled bipolar resistive switching (BRS) has been observed in nanostructured CoFe2O4 (CFO) films using an Al (aluminum)/CoFe2O4/FTO (fluorine-doped tin oxide) device. The fabricated device shows electroforming-free uniform BRS with two clearly distinguished and stable resistance states without any application of compliance current, with a resistance ratio of the high resistance state (HRS) and the low resistance state (LRS) of >102. Small switching voltage (<1 volt) and lower current in both the resistance states confirm the fabrication of a low power consumption device. In the LRS, the conduction mechanism was found to be Ohmic in nature, while the high-resistance state (HRS/OFF state) was governed by the space charge-limited conduction mechanism, which indicates the presence of an interfacial layer with an imperfect microstructure near the top Al/CFO interface. The device shows nonvolatile behavior with good endurance properties, an acceptable resistance ratio, uniform resistive switching due to stable, less random filament formation/rupture, and a control over the resistive switching properties by choosing different stop voltages, which makes the device suitable for its application in future nonvolatile resistive random access memory.

Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial.

PubMed

Liao, Guoyang; Li, Rongcheng; Li, Changgui; Sun, Mingbo; Li, Yanping; Chu, Jiayou; Jiang, Shude; Li, Qihan

2012-01-15

The production of Sabin inactivated poliovirus vaccine (IPV) can reduce biosafety requirements in the posteradication/post-oral poliovirus vaccine (OPV) era. We conducted a phase II, randomized, positive-controlled trial to assess the safety and immunogenicity of Sabin IPV. The test groups (A, B, and C) received 3 doses of high, middle, and low D antigen (D Ag) of Sabin IPV at ages 2, 3, and 4 months, respectively. Infants in 2 control groups, group D and group E, received 3 doses of trivalent OPV and conventional IPV (cIPV), respectively, on the same schedule as that of groups A, B, and C. Serum samples were collected before and 30 days after the administration of the third dose. In total, 500 infants were randomly assigned to 5 groups, and 449 infants completed the vaccine series. No serious adverse events were associated with vaccinations. After 3 doses, the seroconversion rates in groups A, B, C, D, and E were 100%, 97.8%, 96.6%, 100%, and 90.1%, respectively, for type 1 poliovirus; 97.7%, 95.7%, 78.7%, 100%, and 90.1%, respectively, for type 2; and 98.8%, 98.9%, 93.3%, 100%, and 97.8%, respectively, for type 3. Sabin IPV has good safety characteristics. The seroconversion rates for type 1 poliovirus (most appropriate concentration, 15 D Ag units [DU]), type 2 (32 DU), and type 3 (45 DU) Sabin IPV were similar to those of the OPV and cIPV control groups. NCT01056705.

Evaluation of a "Just-in-Time" Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial.

PubMed

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p < 0.01), osteoporosis knowledge (p = 0.04), activation (p < 0.01), dietary self-efficacy (p = 0.06), and osteoporosis care satisfaction (p < 0.01). Compared with PAADRN intervention participants (n = 39), nurse consultation participants had improved dietary self-efficacy (p = 0.07) and osteoporosis care satisfaction (p = 0.05). No significant improvements in osteoporosis-related outcomes were achieved vs PAADRN controls (n = 70). "Just-in-time" nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care.

Interpolating between random walks and optimal transportation routes: Flow with multiple sources and targets

NASA Astrophysics Data System (ADS)

Guex, Guillaume

2016-05-01

In recent articles about graphs, different models proposed a formalism to find a type of path between two nodes, the source and the target, at crossroads between the shortest-path and the random-walk path. These models include a freely adjustable parameter, allowing to tune the behavior of the path toward randomized movements or direct routes. This article presents a natural generalization of these models, namely a model with multiple sources and targets. In this context, source nodes can be viewed as locations with a supply of a certain good (e.g. people, money, information) and target nodes as locations with a demand of the same good. An algorithm is constructed to display the flow of goods in the network between sources and targets. With again a freely adjustable parameter, this flow can be tuned to follow routes of minimum cost, thus displaying the flow in the context of the optimal transportation problem or, by contrast, a random flow, known to be similar to the electrical current flow if the random-walk is reversible. Moreover, a source-targetcoupling can be retrieved from this flow, offering an optimal assignment to the transportation problem. This algorithm is described in the first part of this article and then illustrated with case studies.

Verification of effect of sleep health education program in workplace: a quasi-randomized controlled trial.

PubMed

Nakada, Yukari; Sugimoto, Aya; Kadotani, Hiroshi; Yamada, Naoto

2018-02-07

Short sleep duration is a serious problem that not only enhances the risk of various mental and physical disorders, but also affects the productivity in the workplace. However, in terms of studies focused on workers, there are few reports that evaluated sleeping conditions in an objective way. The purpose of this study is to implement sleep health education in the workplace in terms of primary prevention of mental health disorder and then to investigate the subjective and objective effectiveness of the education using self-administered questionnaires (sleep duration, ESS, AIS, PHQ-9, SF-8) and an activity monitor (MTN-210). Study design is a quasi-randomized controlled trial. Sleep health education was provided through three 50-min lectures (total 150 min) as a single cycle for five months in the Intervention group. We obtained baseline data and then six months later. The study analyzed 70 subjects (36 Intervention group, 34 Control group). The weekday sleep duration for the Control group decreased by 12.9 min, whereas that of the Intervention group increased by 14.3 min (difference of 27.2 min), resulting in a significantly increase in score for the Intervention group. The present study suggests that sleep health education may be beneficial for good sleep habits in workers.

Efficacy of nitroglycerine ointment in the treatment of pediatric anal fissure.

PubMed

Joda, Ali E; Al-Mayoof, Ali F

2017-11-01

Anal fissure is the most common anal disease in children. In the past few decades, the understanding of its pathophysiology has led to a progressive reduction in invasive procedures in favor of conservative treatment based on stool softeners and the relaxation of the anal sphincter. This randomized controlled study assessed the safety and efficacy of nitroglycerine (NTG) ointment in the treatment of pediatric anal fissure, which had not yet been proved. An unequal randomized controlled study included 105 pediatric patients with anal fissure who had presented to the private and outpatient clinics of the Central Teaching Hospital of Pediatrics during the period from February 2015 to May 2016. The control group consisted of 70 patients. Both groups were treated with classical conservative therapy of sitz bath, stool softener, and local anesthetic. In the second group, chemical sphincterotomy with 0.2% NTG ointment was used in 35 patients, and was applied at the anal canal twice daily for 8weeks. The primary outcomes of symptomatic improvement and healed fissure, as well as side effects, were analyzed. The average age of patients was 2years (range, 4months to 5years). Patients in the NTG group had 77% symptomatic relief and 60% healed fissure compared to the control group, which had 54% and 32.8% respectively. All were statistically significant. No serious adverse effects were noticed during the treatment period. The use of 0.2% NTG ointment is an effective therapy for anal fissure in children in terms of good healing rate and rapid symptom relief, but it has the drawback of a long treatment period, making patient compliance more difficult, in addition to the problems of tolerance and recurrence. Prospective randomized controlled study (treatment study). Type 2. Copyright © 2017 Elsevier Inc. All rights reserved.

Randomized controlled trial of peer mentoring for individuals with traumatic brain injury and their significant others.

PubMed

Hanks, Robin A; Rapport, Lisa J; Wertheimer, Jeffrey; Koviak, Carole

2012-08-01

To examine the efficacy of a peer-mentoring program for persons with traumatic brain injury (TBI) and their significant others, and to determine the relationship of this mentoring program to 3 main outcomes: (1) emotional well-being; (2) post-TBI quality of life; and (3) community integration. Randomized controlled trial. Midwestern rehabilitation hospital. Persons with TBI (n=96) and significant others/caregivers (n=62). Persons with TBI and friends/caregivers who knew the person prior to their injury were randomly assigned to a treatment (mentored) or no-treatment (no mentoring) control group immediately prior to discharge from the rehabilitation unit and were mentored for up to 2 years. Peer Mentoring Questionnaire; Brief Symptom Inventory-18; Family Assessment Device; Coping Inventory for Stressful Situations; Short Michigan Alcohol Screening Test; Medical Outcomes Study 12-Item Short-Form Health Survey; and Community Integration Measure. Eighty-eight percent of individuals who were involved in the mentoring program reported positive experiences. t tests revealed that among persons with TBI, individuals who received mentoring had significantly better behavioral control and less chaos in the living environment (P=.04), lower alcohol use (P=.01), less emotion-focused (P=.04) and avoidance coping (P=.03), and good physical quality of life (P=.04) compared with those who did not receive mentoring. Among significant others, mentored individuals demonstrated greater community integration (P=.03) than the nonmentored control group. Mentoring can be an effective way to benefit mood and healthy coping after TBI, and it can help to prevent maladaptive behaviors, such as substance abuse and behavioral dyscontrol, in the living situation. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Rationale and baseline characteristics of PREVENT: a second-generation intervention trial in subjects at-risk (prodromal) of developing first-episode psychosis evaluating cognitive behavior therapy, aripiprazole, and placebo for the prevention of psychosis.

PubMed

Bechdolf, Andreas; Müller, Hendrik; Stützer, Hartmut; Wagner, Michael; Maier, Wolfgang; Lautenschlager, Marion; Heinz, Andreas; de Millas, Walter; Janssen, Birgit; Gaebel, Wolfgang; Michel, Tanja Maria; Schneider, Frank; Lambert, Martin; Naber, Dieter; Brüne, Martin; Krüger-Özgürdal, Seza; Wobrock, Thomas; Riedel, Michael; Klosterkötter, Joachim

2011-09-01

Antipsychotics, cognitive behavioral therapy (CBT), and omega-3-fatty acids have been found superior to control conditions as regards prevention of psychosis in people at-risk of first-episode psychosis. However, no large-scale trial evaluating the differential efficacy of CBT and antipsychotics has been performed yet. In PREVENT, we evaluate CBT, aripiprazole, and clinical management (CM) as well as placebo and CM for the prevention of psychosis in a randomized, double-blind, placebo-controlled trial with regard to the antipsychotic intervention and a randomized controlled trial with regard to the CBT intervention with blinded ratings. The hypotheses are first that CBT and aripiprazole and CM are superior to placebo and CM and second that CBT is not inferior to aripiprazole and CM combined. The primary outcome is transition to psychosis. By November 2010, 156 patients were recruited into the trial. The subjects were substantially functionally compromised (Social and Occupational Functioning Assessment Scale mean score 52.5) and 78.3% presented with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition axis I comorbid diagnosis. Prior to randomization, 51.5% of the participants preferred to be randomized into the CBT arm, whereas only 12.9% preferred pharmacological treatment. First, assessments of audiotaped treatment sessions confirmed the application of CBT-specific skills in the CBT condition and the absence of those in CM. The overall quality rating of the CBT techniques applied in the CBT condition was good. When the final results of the trial are available, PREVENT will substantially expand the current limited evidence base for best clinical practice in people at-risk (prodromal) of first-episode psychosis.

Heavy Slow Resistance Versus Eccentric Training as Treatment for Achilles Tendinopathy: A Randomized Controlled Trial.

PubMed

Beyer, Rikke; Kongsgaard, Mads; Hougs Kjær, Birgitte; Øhlenschlæger, Tommy; Kjær, Michael; Magnusson, S Peter

2015-07-01

Previous studies have shown that eccentric training has a positive effect on Achilles tendinopathy, but few randomized controlled trials have compared it with other loading-based treatment regimens. To evaluate the effectiveness of eccentric training (ECC) and heavy slow resistance training (HSR) among patients with midportion Achilles tendinopathy. Randomized controlled trial; Level of evidence, 1. A total of 58 patients with chronic (>3 months) midportion Achilles tendinopathy were randomized to ECC or HSR for 12 weeks. Function and symptoms (Victorian Institute of Sports Assessment-Achilles), tendon pain during activity (visual analog scale), tendon swelling, tendon neovascularization, and treatment satisfaction were assessed at 0 and 12 weeks and at the 52-week follow-up. Analyses were performed on an intention-to-treat basis. Both groups showed significant (P < .0001) improvements in Victorian Institute of Sports Assessment-Achilles and visual analog scale from 0 to 12 weeks, and these improvements were maintained at the 52-week follow-up. Concomitant with the clinical improvement, there was a significant reduction in tendon thickness and neovascularization. None of these robust clinical and structural improvements differed between the ECC and HSR groups. However, patient satisfaction tended to be greater after 12 weeks with HSR (100%) than with ECC (80%; P = .052) but not after 52 weeks (HSR, 96%; ECC, 76%; P = .10), and the mean training session compliance rate was 78% in the ECC group and 92% in the HSR group, with a significant difference between groups (P < .005). The results of this study show that both traditional ECC and HSR yield positive, equally good, lasting clinical results in patients with Achilles tendinopathy and that the latter tends to be associated with greater patient satisfaction after 12 weeks but not after 52 weeks. © 2015 The Author(s).

Comparing surgical repair with conservative treatment for degenerative rotator cuff tears: a randomized controlled trial.

PubMed

Lambers Heerspink, Frederik O; van Raay, Jos J A M; Koorevaar, Rinco C T; van Eerden, Pepijn J M; Westerbeek, Robin E; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L

2015-08-01

Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff tears. We conducted a randomized controlled trial that included 56 patients with a degenerative full-thickness rotator cuff tear between January 2009 and December 2012; 31 patients were treated conservatively, and rotator cuff repair was performed in 25 patients. Outcome measures, including the Constant-Murley score (CMS), visual analog scale (VAS) pain and VAS disability scores, were assessed preoperatively and after 6 weeks and 3, 6, and 12 months. Magnetic resonance imaging was performed preoperatively and at 12 months postoperatively. At 12 months postoperatively, the mean CMS was 81.9 (standard deviation [SD], 15.6) in the surgery group vs 73.7 (SD, 18.4) in the conservative group (P = .08). VAS pain (P = .04) and VAS disability (P = .02) were significantly lower in the surgery group at the 12-month follow-up. A subgroup analysis showed postoperative CMS results were significantly better in surgically treated patients without a retear compared with conservatively treated patients (88.5 [SD, 6.2] vs 73.7 [SD, 18.4]). In our population of patients with degenerative rotator cuff tears who were randomly treated by surgery or conservative protocol, we did not observe differences in functional outcome as measured with the CMS 1 year after treatment. However, significant differences in pain and disabilities were observed in favor of surgical treatment. The best outcomes in function and pain were seen in patients with an intact rotator cuff postoperatively. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Translation of an Effective Tai Chi Intervention Into a Community-Based Falls-Prevention Program

PubMed Central

Li, Fuzhong; Harmer, Peter; Glasgow, Russell; Mack, Karin A.; Sleet, David; Fisher, K. John; Kohn, Melvin A.; Millet, Lisa M.; Mead, Jennifer; Xu, Junheng; Lin, Mei-Li; Yang, Tingzhong; Sutton, Beth; Tompkins, Yvaughn

2008-01-01

Tai Chi—Moving for Better Balance, a falls-prevention program developed from a randomized controlled trial for community-based use, was evaluated with the RE-AIM framework in 6 community centers. The program had a 100% adoption rate and 87% reach into the target older adult population. All centers implemented the intervention with good fidelity, and participants showed significant improvements in health-related outcome measures. This evidence-based tai chi program is practical to disseminate and can be effectively implemented and maintained in community settings. PMID:18511723

Laparoscopic management of gastric gastrointestinal stromal tumors

PubMed Central

Correa-Cote, Juan; Morales-Uribe, Carlos; Sanabria, Alvaro

2014-01-01

Gastrointestinal stromal tumors (GISTs) are the most frequent gastrointestinal tumors of mesodermal origin. Gastric GISTs represent approximately 70% of all gastrointestinal GISTs. The only curative option is surgical resection. Many surgical groups have shown good results with the laparoscopic approach. There have not been any randomized controlled trials comparing the open vs laparoscopic approach, and all recommendations have been based on observational studies. The experience obtained from gastric laparoscopic surgery during recent decades and the development of specific devices have allowed the treatment of most gastric GISTs through the laparoscopic approach. PMID:25031788

Laparoscopic management of gastric gastrointestinal stromal tumors.

PubMed

Correa-Cote, Juan; Morales-Uribe, Carlos; Sanabria, Alvaro

2014-07-16

Gastrointestinal stromal tumors (GISTs) are the most frequent gastrointestinal tumors of mesodermal origin. Gastric GISTs represent approximately 70% of all gastrointestinal GISTs. The only curative option is surgical resection. Many surgical groups have shown good results with the laparoscopic approach. There have not been any randomized controlled trials comparing the open vs laparoscopic approach, and all recommendations have been based on observational studies. The experience obtained from gastric laparoscopic surgery during recent decades and the development of specific devices have allowed the treatment of most gastric GISTs through the laparoscopic approach.

Advances in heroin addiction treatment with traditional Chinese medicine: a systematic review of recent Chinese language journals.

PubMed

Jordan, James B; Tu, Xiang

2008-01-01

The aim of this review is to critically examine the clinical trial research on Traditional Chinese Medicine (TCM) as an intervention in treating heroin addiction in People's Republic of China. This review examines Chinese-language-only publications for the patent medicines: Shenfu Tuodu, Fukang Pian, and Shifu Sheng. Other compound medicines will be reviewed in future publications. A systematic review of the literature was conducted in Western and Chinese databases. Most trials were excluded because they did not declare randomization and had poor methodology or reporting. The majority of clinical evidence in the random controlled trials demonstrates good evidence for TCM patent medicines in heroin addiction treatment. When compared to typical Western medications, TCMs demonstrate fewer side-effects, in addition to equal measures of treatment efficacy and safety.

Preventing the development of depression at work: a systematic review and meta-analysis of universal interventions in the workplace

PubMed Central

2014-01-01

Background Depression is a major public health problem among working-age adults. The workplace is potentially an important location for interventions aimed at preventing the development of depression, but to date, the mental health impact of universal interventions in the workplace has been unclear. Method A systematic search was conducted in relevant databases to identify randomized controlled trials of workplace interventions aimed at universal prevention of depression. The quality of studies was assessed using the Downs and Black checklist. A meta-analysis was performed using results from studies of adequate methodological quality, with pooled effect size estimates obtained from a random effects model. Results Nine workplace-based randomized controlled trials (RCT) were identified. The majority of the included studies utilized cognitive behavioral therapy (CBT) techniques. The overall standardized mean difference (SMD) between the intervention and control groups was 0.16 (95% confidence interval (CI): 0.07, 0.24, P = 0.0002), indicating a small positive effect. A separate analysis using only CBT-based interventions yielded a significant SMD of 0.12 (95% CI: 0.02, 0.22, P = 0.01). Conclusions There is good quality evidence that universally delivered workplace mental health interventions can reduce the level of depression symptoms among workers. There is more evidence for the effectiveness of CBT-based programs than other interventions. Evidence-based workplace interventions should be a key component of efforts to prevent the development of depression among adults. PMID:24886246

Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial

PubMed Central

van Bakelen, N. B.; Buijs, G. J.; Jansma, J.; de Visscher, J. G. A. M.; Hoppenreijs, Th. J. M.; Bergsma, J. E.; van Minnen, B.; Stegenga, B.; Bos, R. R. M.

2017-01-01

Background Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation. Aim The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery. Materials and methods The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS). Results After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05–3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups. Conclusion In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures. Trial registration http://controlled-trials.com ISRCTN44212338. PMID:28493922

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: long-term follow-up of a randomized controlled trial.

PubMed

Hallén, Magnus; Bergenfelz, Anders; Westerdahl, Johan

2008-03-01

We have conducted a randomized controlled trial of totally extraperitoneal hernia repair (TEP) versus tension-free open repair (Lichtenstein repair); we have presented the results previously up to 1 year after the operation. The aim of this study was to compare patient outcome in both groups at a median follow-up of 7.3 years after operation. Of 168 patients included in a prospective, randomized controlled trial designed to compare TEP with an open tension-free technique, 154 patients (92%) answered a questionnaire and 147 patients (88%) were followed up at an outpatient clinic after a minimum of 6 years after operation. Overall, 89% of patients in the TEP group and 95% of patients in the open group reported complete long-term recovery (P = .23). Permanent impaired inguinal sensibility was more common in the open group (P = .004), whereas the proportion of patients with reported testicular pain was higher in the TEP group (P = .003). Three recurrences were found in the TEP group, and 4 recurrences were found in the open group (P = .99). Four patients in the TEP group underwent operations for complications related to the hernia repair (small bowel obstruction, umbilical hernia, testicular pain, and neuralgia). Overall, both groups showed good long-term results with low rates of recurrences. However, the TEP group was associated with a higher proportion of patients with long-term testicular pain, whereas impaired inguinal sensibility was more common in the open group.

Comparison of topical ropivacaine with and without ketamine on post-surgical pain in children undergoing tonsillectomy: a randomized controlled double-blind study.

PubMed

Hong, Boohwi; Lim, Chae Seong; Kim, Yoon-Hee; Lee, Jung Un; Kim, Yong Min; Jung, Choonho; Jo, Yumin

2017-08-01

Tonsillectomy in pediatric patients may cause severe postoperative pain. Topical local anesthetics are an easy and safe way to control post-tonsillectomy pain, but there is no benefit during the early postoperative stage. Topical ketamine shows a good effect on early stage postoperative pain. We compared the effect of topical ropivacaine with and without ketamine on post-tonsillectomy pain. Patients aged 3-7 years undergoing tonsillectomy were selected to participate in the study. Our study was performed in a randomized, placebo-controlled, double-blind manner. Patients were randomly assigned to one of two groups using computer-generated random numbers. The researchers who assessed the pain score, the caregivers, and the patient were blinded to group assignment. One group received topical ropivacaine with saline (RS group) and the other group received topical ropivacaine with 20 mg ketamine (RK group) on the tonsillar bed. Pain scores using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) at 15 min and 30 min, and at 1, 2, 4, 8, 16 and 24 h were recorded. Rescue analgesic requirement and complications were also recorded. A total of 66 patients were randomly assigned to the RS group (n = 33) and the RK group (n = 33). The mCHEOPS scores were significantly lower in the RK group at 15 min (P = 0.046). The mCHEOPS scores of the two groups decreased with time, but there was no intergroup interaction. The RS group received more analgesics until 1 h after surgery and the RK group received more analgesics during 1-24 h after surgery. There were no differences in adverse outcomes. Topical ropivacaine with ketamine can reduce immediate postoperative pain and analgesic requirement better than ropivacaine alone.

Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

Chen, Yuping; Fanchiang, HsinChen D; Howard, Ayanna

2018-01-01

Researchers recently investigated the effectiveness of virtual reality (VR) in helping children with cerebral palsy (CP) to improve motor function. A systematic review of randomized controlled trials (RCTs) using a meta-analytic method to examine the effectiveness of VR in children with CP was thus needed. The purpose of this study was to update the current evidence about VR by systematically examining the research literature. A systematic literature search of PubMed, CINAHL, Cochrane Central Register of Controlled Trials, ERIC, PsycINFO, and Web of Science up to December 2016 was conducted. Studies with an RCT design, children with CP, comparisons of VR with other interventions, and movement-related outcomes were included. A template was created to systematically code the demographic, methodological, and miscellaneous variables of each RCT. The Physiotherapy Evidence Database (PEDro) scale was used to evaluate the study quality. Effect size was computed and combined using meta-analysis software. Moderator analyses were also used to explain the heterogeneity of the effect sizes in all RCTs. . The literature search yielded 19 RCT studies with fair to good methodological quality. Overall, VR provided a large effect size (d = 0.861) when compared with other interventions. A large effect of VR on arm function (d = 0.835) and postural control (d = 1.003) and a medium effect on ambulation (d = 0.755) were also found. Only the VR type affected the overall VR effect: an engineer-built system was more effective than a commercial system. The RCTs included in this study were of fair to good quality, had a high level of heterogeneity and small sample sizes, and used various intervention protocols. Then compared with other interventions, VR seems to be an effective intervention for improving motor function in children with CP. © 2017 American Physical Therapy Association

Epilation for Minor Trachomatous Trichiasis: Four-Year Results of a Randomised Controlled Trial

PubMed Central

Habtamu, Esmael; Rajak, Saul N.; Tadesse, Zerihun; Wondie, Tariku; Zerihun, Mulat; Guadie, Birhan; Gebre, Teshome; Kello, Amir Bedri; Callahan, Kelly; Mabey, David C. W.; Khaw, Peng T.; Gilbert, Clare E.; Weiss, Helen A.; Emerson, Paul M.; Burton, Matthew J.

2015-01-01

Background Trachomatous trichiasis (TT) needs to be managed to reduce the risk of vision loss. The long-term impact of epilation (a common traditional practice of repeated plucking of lashes touching the eye) in preventing visual impairment and corneal opacity from TT is unknown. We conducted a randomized controlled trial of epilation versus surgery for the management of minor TT (fewer than six lashes touching the eye) in Ethiopia. Here we report the four-year outcome and the effect on vision and corneal opacity. Methodology/ Principal Findings 1300 individuals with minor TT were recruited and randomly assigned to quality trichiasis surgery or repeated epilation using high quality epilation forceps by a trained person with good near vision. Participants were examined six-monthly for two-years, and then at four-years after randomisation. At two-years all epilation arm participants were offered free surgery. At four-years 1151 (88.5%) were re-examined: 572 (88%) and 579 (89%) from epilation and surgery arms, respectively. At that time, 21.1% of the surgery arm participants had recurrent TT; 189/572 (33%) of the epilation arm had received surgery, while 383 (67%) declined surgery and had continued epilating (“epilation-only”). Among the epilation-only group, 207 (54.1%) fully controlled their TT, 166 (43.3%) had minor TT and 10 (2.6%) had major TT (>5 lashes). There were no differences between participants in the epilation-only, epilation-to-surgery and surgery arm participants in changes in visual acuity and corneal opacity between baseline and four-years. Conclusions/ Significance Most minor TT participants randomised to the epilation arm continued epilating and controlled their TT. Change in vision and corneal opacity was comparable between surgery and epilation-only participants. This suggests that good quality epilation with regular follow-up is a reasonable second-line alternative to surgery for minor TT for individuals who either decline surgery or do not have immediate access to surgical treatment. PMID:25768796

Quality of life outcomes from the Exercise and Nutrition Enhance Recovery and Good Health for You (ENERGY)-randomized weight loss trial among breast cancer survivors

PubMed Central

Colditz, Graham A.; Rock, Cheryl L.; Sedjo, Rebecca L.; Liu, Jingxia; Wolin, Kathleen Y.; Krontiras, Helen; Byers, Tim; Pakiz, Bilgé; Parker, Barbara A.; Naughton, Michael; Elias, Anthony; Ganz, Patricia A.

2015-01-01

Obesity is a poor prognostic factor and is negatively related to quality of life (QOL) in breast cancer survivors. Exercise and Nutrition to Enhance Recovery and Good Health for You is the largest weight loss trial completed among cancer survivors. Percent losses in body weight with an intensive group-based intervention versus an attention control were 6.0 versus 1.5 % (p < 0.0001) and 3.7 versus 1.3 % (p<0.0001) at 12 and 24 months, respectively. ENERGY also was designed to answer the research question: Does weight loss significantly improve vitality and physical function (key components of QOL)? 692 breast cancer survivors (BMI: 25–45 kg/m2) at 4 US sites were randomized to a year-long intensive intervention of 52 group sessions and telephone counseling contacts versus a non-intensive (control) of two in-person counseling sessions. Weight, self-reported QOL, and symptoms were measured semi-annually for two years. Significant decreases in physical function and increases in symptoms were observed among controls from baseline to 6 months, but not in the intervention arm, −3.45 (95 % Confidence Interval [CI] −6.10, –0.79, p = 0.0109) and 0.10 (95 %CI 0.04, 0.16, p = 0.0021), respectively. Improvements in vitality were seen in both arms but trended toward greater improvement in the intervention arm −2.72 (95 % CI −5.45, 0.01, p = 0.0508). These differences diminished over time; however, depressive symptoms increased in the intervention versus control arms and became significant at 24 months, −1.64 (95 % CI −3.13, –0.15, p = 0.0308). Increased QOL has been reported in shorter term diet and exercise trials among cancer survivors. These longer term data suggest that diet and exercise interventions improve some aspects of QOL, but these benefits may diminish over time. PMID:26518022

Population levels of wellbeing and the association with social capital.

PubMed

Taylor, A W; Kelly, G; Dal Grande, E; Kelly, D; Marin, T; Hey, N; Burke, K J; Licinio, J

2017-07-03

This research investigates wellbeing at the population level across demographic, social and health indicators and assesses the association between wellbeing and social capital. Data from a South Australian monthly chronic disease/risk factor surveillance system of randomly selected adults (mean age 48.7 years; range 16-99) from 2014/5 (n = 5551) were used. Univariable analyses compared wellbeing/social capital indicators, socio-demographic, risk factors and chronic conditions. Multi-nominal logistic regression modelling, adjusting for multiple covariates was used to simultaneously estimate odds ratios for good wellbeing (reference category) versus neither good nor poor, and good wellbeing versus poor wellbeing. 48.6% were male, mean age 48.7 (sd 18.3), 54.3% scored well on all four of the wellbeing indicators, and positive social capital indicators ranged from 93.1% for safety to 50.8% for control over decisions. The higher level of social capital corresponded with the good wellbeing category. Modeling showed higher odds ratios for all social capital variables for the lowest level of wellbeing. These higher odds ratios remained after adjusting for confounders. The relationship between wellbeing, resilience and social capital highlights areas for increased policy focus.

Ketoanalogue-Supplemented Vegetarian Very Low-Protein Diet and CKD Progression.

PubMed

Garneata, Liliana; Stancu, Alexandra; Dragomir, Diana; Stefan, Gabriel; Mircescu, Gabriel

2016-07-01

Dietary protein restriction may improve determinants of CKD progression. However, the extent of improvement and effect of ketoanalogue supplementation are unclear. We conducted a prospective, randomized, controlled trial of safety and efficacy of ketoanalogue-supplemented vegetarian very low-protein diet (KD) compared with conventional low-protein diet (LPD). Primary end point was RRT initiation or >50% reduction in initial eGFR. Nondiabetic adults with stable eGFR<30 ml/min per 1.73 m(2), proteinuria <1 g/g urinary creatinine, good nutritional status, and good diet compliance entered a run-in phase on LPD. After 3 months, compliant patients were randomized to KD (0.3 g/kg vegetable proteins and 1 cps/5 kg ketoanalogues per day) or continue LPD (0.6 g/kg per day) for 15 months. Only 14% of screened patients patients were randomized, with no differences between groups. Adjusted numbers needed to treat (NNTs; 95% confidence interval) to avoid composite primary end point in intention to treat and per-protocol analyses in one patient were 4.4 (4.2 to 5.1) and 4.0 (3.9 to 4.4), respectively, for patients with eGFR<30 ml/min per 1.73 m(2) Adjusted NNT (95% confidence interval) to avoid dialysis was 22.4 (21.5 to 25.1) for patients with eGFR<30 ml/min per 1.73 m(2) but decreased to 2.7 (2.6 to 3.1) for patients with eGFR<20 ml/min per 1.73 m(2) in intention to treat analysis. Correction of metabolic abnormalities occurred only with KD. Compliance to diet was good, with no changes in nutritional parameters and no adverse reactions. Thus, this KD seems nutritionally safe and could defer dialysis initiation in some patients with CKD. Copyright © 2016 by the American Society of Nephrology.

Effects of calcium on the incidence of recurrent colorectal adenomas

PubMed Central

Veettil, Sajesh K.; Ching, Siew Mooi; Lim, Kean Ghee; Saokaew, Surasak; Phisalprapa, Pochamana; Chaiyakunapruk, Nathorn

2017-01-01

Abstract Background: Protective effects of calcium supplementation against colorectal adenomas have been documented in systematic reviews; however, the results have not been conclusive. Our objective was to update and systematically evaluate the evidence for calcium supplementation taking into consideration the risks of systematic and random error and to GRADE the evidence. Methods: The study comprised a systematic review with meta-analysis and trial sequential analysis (TSA) of randomized controlled trials (RCTs). We searched for RCTs published up until September 2016. Retrieved trials were evaluated using risk of bias. Primary outcome measures were the incidences of any recurrent adenomas and of advanced adenomas. Meta-analytic estimates were calculated with the random-effects model and random errors were evaluated with trial sequential analyses (TSAs). Results: Five randomized trials (2234 patients with a history of adenomas) were included. Two of the 5 trials showed either unclear or high risks of bias in most criteria. Meta-analysis of good quality RCTs suggest a moderate protective effect of calcium supplementation on recurrence of adenomas (relative risk [RR], 0.88 [95% CI 0.79–0.99]); however, its effects on advanced adenomas did not show statistical significance (RR, 1.02 [95% CI 0.67–1.55]). Subgroup analyses demonstrated a greater protective effect on recurrence of adenomas with elemental calcium dose ≥1600 mg/day (RR, 0.74 [95% CI 0.56–0.97]) compared to ≤1200 mg/day (RR, 0.84 [95% CI 0.73–0.97]). No major serious adverse events were associated with the use of calcium, but there was an increase in the incidence of hypercalcemia (P = .0095). TSA indicated a lack of firm evidence for a beneficial effect. Concerns with directness and imprecision rated down the quality of the evidence to “low.” Conclusion: The available good quality RCTs suggests a possible beneficial effect of calcium supplementation on the recurrence of adenomas; however, TSA indicated that the accumulated evidence is still inconclusive. Using GRADE-methodology, we conclude that the quality of evidence is low. Large well-designed randomized trials with low risk of bias are needed. PMID:28796047

A systematic review of treatments for constipation in children and young adults undergoing cancer treatment.

PubMed

Phillips, Robert S; Gibson, Faith

2008-11-01

Constipation is a common problem in children and young people with cancer. Treatment of this complication is subject to wide variation in practice. We undertook a systematic review of randomized controlled trials to build a rational approach to prophylaxis and treatment of this complication. Randomized controlled trials of any intervention (pharmacologic, physical, complementary, or alternative) to prevent or treat constipation were to be included if they included children and young people 16 years old and younger who were undergoing treatment for malignancy. Of the 1336 abstracts retrieved from the searches, only 3 papers were identified for further assessment, and no studies were suitable for inclusion. There are no good data on which to base the management of constipation in children and young people with cancer. This is not to say that we do not know if laxatives work-they are clearly effective. Our ignorance is of the comparative value of different agents. The practical problems with undertaking specific trials of supportive care measures are large, and integration of such questions into treatment trials is essential.

Biodegradable implants versus standard metal fixation for displaced radial head fractures. A prospective, randomized, multicenter study.

PubMed

Helling, Hanns-Joachim; Prokop, Axel; Schmid, Hans Ulrich; Nagel, Michael; Lilienthal, Jürgen; Rehm, Klaus Emil

2006-01-01

This multicenter, prospective, randomized study compares the use of biodegradable polylactide pins with standard metal mini-fragment implants for the treatment of displaced radial head fractures. It compares complication rates and clinical outcomes of both treatment methods. At 2 years, 135 (82%) of 164 patients were available for evaluation. Equivalence of treatment method was defined as a difference of 10% or less in the number of complication-free patients. Functional status was assessed by using the Broberg and Morrey Elbow Score and compared by an unpaired t test. Good or excellent clinical results were achieved by 92% (56/61) of the control patients and 96% (71/74) of the polylactide patients. The incidence of complication-free patients was 3.7% less in the polylactide group than in the control group. The 1-sided 95% confidence interval for the treatment difference between the 2 groups was more than -6.1%. Biodegradable polylactide pins have at least comparable outcomes as standard metal implants for the internal fixation of reconstructable displaced radial head fractures.

Effectiveness of information and communication technologies interventions to increase mental health literacy: A systematic review.

PubMed

Tay, Jing Ling; Tay, Yi Fen; Klainin-Yobas, Piyanee

2018-06-13

Most mental health conditions affect adolescent and young adults. The onset of many mental disorders occurs in the young age. This is a critical period to implement interventions to enhance mental health literacy (MHL) and to prevent the occurrence of mental health problems. This systematic review examined the effectiveness of information and communication technologies interventions on MHL (recognition of conditions, stigma and help-seeking). The authors searched for both published and unpublished studies. Nineteen studies were included with 9 randomized controlled trials and 10 quasi-experimental studies. Informational interventions were useful to enhance MHL of less-known disorders such as anxiety disorder and anorexia, but not depression. Interventions that were effective in enhancing depression MHL comprised active component such as videos or quizzes. Interventions that successfully elevated MHL also reduced stigma. Elevated MHL levels did not improve help-seeking, and reduction in stigma levels did not enhance help-seeking behaviours. Future good quality, large-scale, multi-sites randomized controlled trials are necessary to evaluate MHL interventions. © 2018 John Wiley & Sons Australia, Ltd.

Efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II trial): study protocol for a randomized controlled trial.

PubMed

Tamura, Tomoyoshi; Hayashida, Kei; Sano, Motoaki; Onuki, Shuko; Suzuki, Masaru

2017-10-23

Hydrogen gas inhalation (HI) improved survival and neurological outcomes in an animal model of post-cardiac arrest syndrome (PCAS). The feasibility and safety of HI for patients with PCAS was confirmed in a pilot study. The objective of this study is to evaluate the efficacy of HI for patients with PCAS. The efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II) trial is an investigator-initiated, randomized, double-blind, placebo-controlled trial designed to enroll 360 adult comatose (Glasgow Coma Scale score < 8) patients who will be resuscitated following an out-of-hospital cardiac arrest of a presumed cardiac cause. The patients will be randomized (1:1) to either the HI or control group. Patients in the HI group will inhale 2% hydrogen with 24% to 50% oxygen, and those in the control group will inhale 24% to 50% oxygen for 18 h after admission via mechanical ventilation. Multidisciplinary post-arrest care, including targeted temperature management (TTM) between 33 °C and 36 °C, will be provided in accordance with the latest guidelines. The primary outcome of interest is the 90-day neurological outcome, as evaluated using the Cerebral Performance Categories scale (CPC). The secondary outcomes of interest are the 90-day survival rate and other neurological outcomes. This study will provide 80% power to detect a 15% change in the proportion of patients with good neurological outcomes (CPCs of 1 and 2), from 50% to 65%, with an overall significance level of 0.05. The first multicenter randomized trial is underway to confirm the efficacy of HI on neurological outcomes in comatose out-of-hospital cardiac arrest survivors. Our study has the potential to address HI as an appealing and innovative therapeutic strategy for PCAS in combination with TTM. University Hospital Medical Information Network (UMIN), 000019820 . Registered on 17 November 2015.

Comparative Effectiveness of Anticholinergic Therapy for Overactive Bladder in Women: A Systematic Review and Meta-analysis.

PubMed

Reynolds, W Stuart; McPheeters, Melissa; Blume, Jeffery; Surawicz, Tanya; Worley, Katherine; Wang, Li; Hartmann, Katherine

2015-06-01

To summarize evidence about reduction in voiding and resolution of urine loss in overactive bladder comparing data from the active drug arms with the placebo arms of randomized trials. We searched MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, and ClinicalTrials.gov in March 2014. Multiple reviewers screened original research published in English on community-dwelling women with nonneurogenic overactive bladder undergoing pharmacotherapy with medications available in the United States. Studies in which women comprised less than 75% of the population or those with a sample size less than 50 were excluded. Study designs included randomized controlled trials for meta-analysis and cohorts, case-control, and case series for harms data. Our search identified 50 randomized controlled trials from among 144 candidate publications (one was of good quality, 38 fair, and 11 poor). Multiple team members performed data extraction independently with secondary review of data entry to ensure quality and validity. Studies were assessed for risk of bias. Meta-analysis was performed using fixed-effects regression models. The primary outcomes and measurements were the numbers of daily voids and urge incontinence episodes. Medications delivered as a daily dose reduced urge incontinence by 1.73 episodes per day (95% confidence interval [CI] 1.37-2.09) and voids by 2.06 per day (95% CI 1.66-2.46) from 2.79 (95% CI 0.70-4.88) and 11.28 (95% CI 7.77-14.80) at baseline, respectively. Placebo reduced urge incontinence episodes by 1.06 (95% CI 0.7-1.42) and voids by 1.2 (95% CI 0.72-1.67) per day. No individual agent demonstrated superiority over another. The majority (98%) of studies reporting funding were sponsored by industry. Evidence from more than 27,000 women participating in randomized controlled trials suggests that improvement in symptoms with anticholinergic management of overactive bladder is modest and rarely fully resolves symptoms.

Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial.

PubMed

Magee, Laura A; von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Gruslin, Andrée; Helewa, Michael; Hutton, Eileen; Lee, Shoo K; Logan, Alexander G; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G; Moutquin, Jean Marie

2016-07-01

For women with chronic or gestational hypertension in CHIPS (Control of Hypertension In Pregnancy Study, NCT01192412), we aimed to examine whether clinical predictors collected at randomization could predict adverse outcomes. This was a planned, secondary analysis of data from the 987 women in the CHIPS Trial. Logistic regression was used to examine the impact of 19 candidate predictors on the probability of adverse perinatal (pregnancy loss or high level neonatal care for >48 h, or birthweight <10th percentile) or maternal outcomes (severe hypertension, preeclampsia, or delivery at <34 or <37 weeks). A model containing all candidate predictors was used to start the stepwise regression process based on goodness of fit as measured by the Akaike information criterion. For face validity, these variables were forced into the model: treatment group ("less tight" or "tight" control), antihypertensive type at randomization, and blood pressure within 1 week before randomization. Continuous variables were represented continuously or dichotomized based on the smaller p-value in univariate analyses. An area-under-the-receiver-operating-curve (AUC ROC) of ≥0.70 was taken to reflect a potentially useful model. Point estimates for AUC ROC were <0.70 for all but severe hypertension (0.70, 95% CI 0.67-0.74) and delivery at <34 weeks (0.71, 95% CI 0.66-0.75). Therefore, no model warranted further assessment of performance. CHIPS data suggest that when women with chronic hypertension develop an elevated blood pressure in pregnancy, or formerly normotensive women develop new gestational hypertension, maternal and current pregnancy clinical characteristics cannot predict adverse outcomes in the index pregnancy. © 2016 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

PubMed

Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

2018-06-07

Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

A LARGE-SCALE CLUSTER RANDOMIZED TRIAL TO DETERMINE THE EFFECTS OF COMMUNITY-BASED DIETARY SODIUM REDUCTION – THE CHINA RURAL HEALTH INITIATIVE SODIUM REDUCTION STUDY

PubMed Central

Li, Nicole; Yan, Lijing L.; Niu, Wenyi; Labarthe, Darwin; Feng, Xiangxian; Shi, Jingpu; Zhang, Jianxin; Zhang, Ruijuan; Zhang, Yuhong; Chu, Hongling; Neiman, Andrea; Engelgau, Michael; Elliott, Paul; Wu, Yangfeng; Neal, Bruce

2013-01-01

Background Cardiovascular diseases are the leading cause of death and disability in China. High blood pressure caused by excess intake of dietary sodium is widespread and an effective sodium reduction program has potential to improve cardiovascular health. Design This study is a large-scale, cluster-randomized, trial done in five Northern Chinese provinces. Two counties have been selected from each province and 12 townships in each county making a total of 120 clusters. Within each township one village has been selected for participation with 1:1 randomization stratified by county. The sodium reduction intervention comprises community health education and a food supply strategy based upon providing access to salt substitute. Subsidization of the price of salt substitute was done in 30 intervention villages selected at random. Control villages continued usual practices. The primary outcome for the study is dietary sodium intake level estimated from assays of 24 hour urine. Trial status The trial recruited and randomized 120 townships in April 2011. The sodium reduction program was commenced in the 60 intervention villages between May and June of that year with outcome surveys scheduled for October to December 2012. Baseline data collection shows that randomisation achieved good balance across groups. Discussion The establishment of the China Rural Health Initiative has enabled the launch of this large-scale trial designed to identify a novel, scalable strategy for reduction of dietary sodium and control of blood pressure. If proved effective, the intervention could plausibly be implemented at low cost in large parts of China and other countries worldwide. PMID:24176436

The Impact of the Good Behavior Game, a Universal Classroom-Based Preventive Intervention in First and Second Grades, on High-Risk Sexual Behaviors and Drug Abuse and Dependence Disorders into Young Adulthood

PubMed Central

Wang, Wei; Mackenzie, Amelia C. L.; Brown, C. Hendricks; Ompad, Danielle C.; Or, Flora; Ialongo, Nicholas S.; Poduska, Jeanne M.; Windham, Amy

2013-01-01

The Good Behavior Game (GBG), a method of teacher classroom behavior management, was tested in first-and second-grade classrooms in 19 Baltimore City Public Schools beginning in the 1985–1986 school year. The intervention was directed at the classroom as a whole to socialize children to the student role and reduce aggressive, disruptive behaviors, confirmed antecedents of a profile of externalizing problem outcomes. This article reports on the GBG impact on the courses and interrelationships among aggressive, disruptive behavior through middle school, risky sexual behaviors, and drug abuse and dependence disorders through ages 19–21. In five poor to lower-middle class, mainly African American urban areas, classrooms within matched schools were assigned randomly to either the GBG intervention or the control condition. Balanced assignment of children to classrooms was made, and teachers were randomly assigned to intervention or control. Analyses involved multilevel growth mixture modeling. By young adulthood, significant GBG impact was found in terms of reduced high-risk sexual behaviors and drug abuse and dependence disorders among males who in first grade and through middle school were more aggressive, disruptive. A replication with the next cohort of first-grade children with the same teachers occurred during the following school year, but with minimal teacher mentoring and monitoring. Findings were not significant but generally in the predicted direction. A universal classroom-based prevention intervention in first- and second-grade classrooms can reduce drug abuse and dependence disorders and risky sexual behaviors. PMID:23070695

How strong is the evidence that solar ultraviolet B and vitamin D reduce the risk of cancer?: An examination using Hill's criteria for causality.

PubMed

Grant, William B

2009-01-01

The ultraviolet-B (UVB)-vitamin D-cancer hypothesis was proposed in 1980. Since then, several ecological and observational studies have examined the hypothesis, in addition to one good randomized, controlled trial. Also, the mechanisms whereby vitamin D reduces the risk of cancer have been elucidated. This report aims to examine the evidence to date with respect to the criteria for causality in a biological system first proposed by Robert Koch and later systematized by A. Bradford Hill. The criteria of most relevance are strength of association, consistency, biological gradient, plausibility/mechanisms and experimental verification. Results for several cancers generally satisfy these criteria. Results for breast and colorectal cancer satisfy the criteria best, but there is also good evidence that other cancers do as well, including bladder, esophageal, gallbladder, gastric, ovarian, rectal, renal and uterine corpus cancer, as well as Hodgkin's and non-Hodgkin's lymphoma. Several cancers have mixed findings with respect to UVB and/or vitamin D, including pancreatic and prostate cancer and melanoma. Even for these, the benefit of vitamin D seems reasonably strong. Although ecological and observational studies are not generally regarded as able to provide convincing evidence of causality, the fact that humanity has always existed with vitamin D from solar UVB irradiance means that there is a wealth of evidence to be harvested using the ecological and observational approaches. Nonetheless, additional randomized, controlled trials are warranted to further examine the link between vitamin D and cancer incidence, survival and mortality.

Patient-reported outcomes of azelaic acid foam 15% for patients with papulopustular rosacea: secondary efficacy results from a randomized, controlled, double-blind, phase 3 trial.

PubMed

Tyring, Stephen; Solomon, James A; Staedtler, Gerald; Lott, Jason P; Nkulikiyinka, Richard; Shakery, Kaweh

2016-10-01

Patient-reported treatment outcomes are important for evaluating the impact of drug therapies on patient experience. A randomized, double-blind, vehicle-controlled, parallel-group, multicenter, phase 3 study was conducted in 961 participants to assess patient perception of efficacy, utility, and effect on quality of life (QOL) of an azelaic acid (AzA) 15% foam formulation for the treatment of papulopustular rosacea (PPR). Secondary end points included patient-reported global assessment of treatment response, global assessment of tolerability, and opinion on cosmetic acceptability and practicability of product use. Quality of life assessments included the Dermatology Quality of Life Index (DLQI) and Rosacea Quality of Life Index (RosaQOL). Self-reported global assessment of treatment response favored AzA foam over vehicle foam (P<.001), with 57.2% of the AzA foam group reporting excellent or good improvement versus 44.7% in the vehicle foam group. Tolerability was rated excellent or good in 67.8% of the AzA foam group versus 78.2% of the vehicle foam group. Mean overall DLQI scores at end of treatment (EoT) were improved (P=.018) in favor of the AzA foam group compared with the vehicle foam group. Both treatment groups showed improvements in RosaQOL. Treatment with AzA foam was associated with improved QOL and meaningful reductions in the patient-perceived burden of PPR, which correlates with earlier reported primary end points of this study and supports the inclusion of patient perspectives in studies evaluating the effects of topical dermatologic treatments.

Using an informed consent in mammography screening: a randomized trial.

PubMed

Baena-Cañada, José M; Rosado-Varela, Petra; Expósito-Álvarez, Inmaculada; González-Guerrero, Macarena; Nieto-Vera, Juan; Benítez-Rodríguez, Encarnación

2015-12-01

Spanish women do not make an informed choice regarding breast cancer screening (BCS). Our aim was to evaluate the impact of receiving information regarding real BCS benefits and risks on knowledge, attitude, decision, feelings, and worries about cancer. Randomized controlled clinical trial of 355 women aged between 45 and 67 years, 177 and 178 assigned to the intervention group (IG) and control group (CG), respectively. After breast screening, women received either Nordic Cochrane Centre information on BCS or standard information. The primary outcome (knowledge) was determined from questionnaire administered at baseline and after a month. Answers were scored from 0 to 10 and scores of 5 or more indicated that women were well informed (had "good knowledge"). Questionnaires regarding attitudes, future screening intentions, and psychosocial impact were also administered. The Chi-squared and Student's t-tests were used to compare qualitative and quantitative variables, respectively. Good knowledge was acquired by 32 (18.10%) IG women and 15 (8.40%) CG women (P = 0.008). Mean scores from first to second interview increased from 2.97 (SD 1.16) to 3.43 (SD 1.39) in the CG and from and from 2.96 (SD 1.23) to 3.95 (SD 1.78) (P = 0.002) in the IG. No differences were found in the secondary endpoints. Women receiving information based on the Nordic Cochrane Centre document were better informed. This means of providing information is not very efficacious, nor does it modify attitude, decision, feelings, or worries about cancer. © 2015 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

The impact of the Good Behavior Game, a universal classroom-based preventive intervention in first and second grades, on high-risk sexual behaviors and drug abuse and dependence disorders into young adulthood.

PubMed

Kellam, Sheppard G; Wang, Wei; Mackenzie, Amelia C L; Brown, C Hendricks; Ompad, Danielle C; Or, Flora; Ialongo, Nicholas S; Poduska, Jeanne M; Windham, Amy

2014-02-01

The Good Behavior Game (GBG), a method of teacher classroom behavior management, was tested in first- and second-grade classrooms in 19 Baltimore City Public Schools beginning in the 1985-1986 school year. The intervention was directed at the classroom as a whole to socialize children to the student role and reduce aggressive, disruptive behaviors, confirmed antecedents of a profile of externalizing problem outcomes. This article reports on the GBG impact on the courses and interrelationships among aggressive, disruptive behavior through middle school, risky sexual behaviors, and drug abuse and dependence disorders through ages 19-21. In five poor to lower-middle class, mainly African American urban areas, classrooms within matched schools were assigned randomly to either the GBG intervention or the control condition. Balanced assignment of children to classrooms was made, and teachers were randomly assigned to intervention or control. Analyses involved multilevel growth mixture modeling. By young adulthood, significant GBG impact was found in terms of reduced high-risk sexual behaviors and drug abuse and dependence disorders among males who in first grade and through middle school were more aggressive, disruptive. A replication with the next cohort of first-grade children with the same teachers occurred during the following school year, but with minimal teacher mentoring and monitoring. Findings were not significant but generally in the predicted direction. A universal classroom-based prevention intervention in first- and second-grade classrooms can reduce drug abuse and dependence disorders and risky sexual behaviors.

Prediction models for clustered data: comparison of a random intercept and standard regression model

PubMed Central

2013-01-01

Background When study data are clustered, standard regression analysis is considered inappropriate and analytical techniques for clustered data need to be used. For prediction research in which the interest of predictor effects is on the patient level, random effect regression models are probably preferred over standard regression analysis. It is well known that the random effect parameter estimates and the standard logistic regression parameter estimates are different. Here, we compared random effect and standard logistic regression models for their ability to provide accurate predictions. Methods Using an empirical study on 1642 surgical patients at risk of postoperative nausea and vomiting, who were treated by one of 19 anesthesiologists (clusters), we developed prognostic models either with standard or random intercept logistic regression. External validity of these models was assessed in new patients from other anesthesiologists. We supported our results with simulation studies using intra-class correlation coefficients (ICC) of 5%, 15%, or 30%. Standard performance measures and measures adapted for the clustered data structure were estimated. Results The model developed with random effect analysis showed better discrimination than the standard approach, if the cluster effects were used for risk prediction (standard c-index of 0.69 versus 0.66). In the external validation set, both models showed similar discrimination (standard c-index 0.68 versus 0.67). The simulation study confirmed these results. For datasets with a high ICC (≥15%), model calibration was only adequate in external subjects, if the used performance measure assumed the same data structure as the model development method: standard calibration measures showed good calibration for the standard developed model, calibration measures adapting the clustered data structure showed good calibration for the prediction model with random intercept. Conclusion The models with random intercept discriminate better than the standard model only if the cluster effect is used for predictions. The prediction model with random intercept had good calibration within clusters. PMID:23414436

Prediction models for clustered data: comparison of a random intercept and standard regression model.

PubMed

Bouwmeester, Walter; Twisk, Jos W R; Kappen, Teus H; van Klei, Wilton A; Moons, Karel G M; Vergouwe, Yvonne

2013-02-15

When study data are clustered, standard regression analysis is considered inappropriate and analytical techniques for clustered data need to be used. For prediction research in which the interest of predictor effects is on the patient level, random effect regression models are probably preferred over standard regression analysis. It is well known that the random effect parameter estimates and the standard logistic regression parameter estimates are different. Here, we compared random effect and standard logistic regression models for their ability to provide accurate predictions. Using an empirical study on 1642 surgical patients at risk of postoperative nausea and vomiting, who were treated by one of 19 anesthesiologists (clusters), we developed prognostic models either with standard or random intercept logistic regression. External validity of these models was assessed in new patients from other anesthesiologists. We supported our results with simulation studies using intra-class correlation coefficients (ICC) of 5%, 15%, or 30%. Standard performance measures and measures adapted for the clustered data structure were estimated. The model developed with random effect analysis showed better discrimination than the standard approach, if the cluster effects were used for risk prediction (standard c-index of 0.69 versus 0.66). In the external validation set, both models showed similar discrimination (standard c-index 0.68 versus 0.67). The simulation study confirmed these results. For datasets with a high ICC (≥15%), model calibration was only adequate in external subjects, if the used performance measure assumed the same data structure as the model development method: standard calibration measures showed good calibration for the standard developed model, calibration measures adapting the clustered data structure showed good calibration for the prediction model with random intercept. The models with random intercept discriminate better than the standard model only if the cluster effect is used for predictions. The prediction model with random intercept had good calibration within clusters.

A randomized controlled trial on the effects of combined aerobic-resistance exercise on muscle strength and fatigue, glycemic control and health-related quality of life of type 2 diabetes patients.

PubMed

Tomas-Carus, Pablo; Ortega-Alonso, Alfredo; Pietilainen, Kirsi H; Santos, Vitoria; Goncalves, Helena; Ramos, Jorge; Raimundo, Armando

2016-05-01

The aim of this paper was to evaluate the effects of a 12-weeks combined aerobic-resistance exercise therapy on fatigue and isokinetic muscle strength, glycemic control and health-related quality of life (HRQoL) in moderately affected type 2 diabetes (T2DM) patients. A randomized controlled trial design was employed. Forty-three T2DM patients were assigned to an exercise group (N.=22), performing 3 weekly sessions of 60 minutes of combined aerobic-resistance exercise for 12-weeks; or a no exercise control group (N.=21). Both groups were evaluated at a baseline and after 12-weeks of exercise therapy for: 1) muscle strength and fatigue by isokinetic dynamometry; 2) plasma glycated hemoglobin A1C (HbA1C); and 3) HRQoL utilizing the SF-36 questionnaire. The exercise therapy led to improvements in muscle fatigue in knee extensors (-55%) and increased muscle strength in knee flexors and extensors (+15 to +30%), while HbA1C decreased (-18%). In addition, the exercising patients showed sizeable improvements in HRQoL: physical function (+53%), vitality (+21%) and mental health (+40%). Twelve-weeks of combined aerobic-resistance exercise was highly effective to improve muscle strength and fatigue, glycemic control and several aspects of HRQoL in T2DM patients. These data encourage the use of aerobic and resistance exercise in the good clinical care of T2DM.

Race-ethnicity on blood pressure control after ischemic stroke: a prospective cohort study.

PubMed

Nguyen-Huynh, Mai N; Hills, Nancy K; Sidney, Stephen; Klingman, Jeffrey G; Johnston, S Claiborne

2017-01-01

Disparities in health care access and socioeconomic status (SES) have been associated with racial-ethnic differences in blood pressure (BP) control. We examined post-ischemic stroke BP in a multiethnic cohort with good health care access. We included all hypertensive patients (n = 2972) from a randomized quality improvement trial on secondary stroke prevention, conducted in 14 Kaiser Permanente hospitals in Northern California from 2004-2006 (QUISP). Average age 73.2 ± 12.2 years; 52% female, 66% non-Hispanic white, 14% African-American, 11% Asian, 8% Hispanic, and 1% other. Demographics, diagnoses, health care utilization, BP measurements, and medications were obtained as part of routine care. We used random effects logistic regression models to examine race as a predictor of blood pressure control (<140/90 mm Hg) at 6 months post-discharge, adjusted for SES, age, gender, dementia, antihypertensive therapy, and attendance at follow-up visits. At 6 months, BP was controlled in 52.7% of blacks compared to 61.4% of whites (OR = 0.63, 95% CI, 0.48-0.82, P = .001). Black race remained independently associated with poorer BP control in adjusted analysis, although blacks were as likely to attend post-discharge visits, and more likely to be on any antihypertensive therapy than whites. Greater difficulty in controlling BP and lifestyle differences may account for this difference. Copyright © 2016 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

The relationship between mental health and social solidarity among apartment residents in shahrekord, iran.

PubMed

Ganji, Forouzan; Nekooee, Afsaneh; Safdari, Faranak; Parvin, Neda; Shafei, Akbar; Ganji, Hanife

2012-01-01

To examine the relationship between psychological well-being and social solidarity of apartment residents in Shahrekord, Iran. A sample of 200 apartment dwellers was selected randomly. Fessler Social Solidarity Inventory and General Health Questionnaire were used to gather data. Using partial correlation test and having controlled the effect of age, sex and education, we found significant relationship between mental health and social solidarity (r = 0.47; p= 0.023). After controlling education and marital status, it was also revealed that women were in a better solidarity situation compared to men (p< 0.05). There is a relation between the mental health and social solidarity of apartment residents in Sharekord. Good mental health accompanied with better social solidarity.

Comparative study of intravenous Tramadol versus Ketorolac for preventing postoperative pain after third molar surgery--a prospective randomized study.

PubMed

Gopalraju, Prathibha; Lalitha, Ramanujapuram Manikarnike; Prasad, Kavitha; Ranganath, Krishnappa

2014-07-01

The aim of this comparative, prospective, randomized, controlled study was to evaluate two different regimens of analgesics: a preoperative intravenous dose of either Tramadol or Ketorolac given 10 min prior to surgery to assess their impact on clinical recovery after third molar surgery. Forty patients requiring surgical extraction of unilateral impacted mandibular third molars similar in position were enrolled in the study. Patients were randomly divided into two groups based on permuting the numbers. Patients in Group 1 and Group 2 were administered either Tramadol 50 mg or Ketorolac 30 mg, intravenously, 10 min prior to surgery. The difference in postoperative pain was assessed by four primary points: pain intensity as measured by a 10 mm visual analogue scale hourly for 12 h, median time to rescue analgesics, number of analgesics consumed and patient's overall 5-point global assessment scale. Throughout the 12 h investigation period, patients treated with Ketorolac reported significantly lower pain intensity scores, significantly longer time to rescue analgesics (Acetaminophen 500 mg) and less intake of postoperative analgesics. In Group 2, 40% of the patient had good overall assessment as compared to Group 1 where only 25% of patients had good overall assessment. The current study shows that pre-emptive use of Inj. Ketorolac 30 mg intravenously can reduce the severity of the postoperative sequelae of asymptomatic impacted mandibular third molar surgery. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Impact of the Good Behavior Game, a Universal Classroom–Based Behavior Intervention, on Young Adult Service Use for Problems with Emotions, Behavior, or Drugs or Alcohol

PubMed Central

Poduska, Jeanne; Kellam, Sheppard; Wang, Wei; Brown, C. Hendricks; Ialongo, Nicholas; Toyinbo, Peter

2009-01-01

Background The Good Behavior Game (GBG) is a classroom behavior management strategy focused on socializing children to the role of student and aimed at reducing early aggressive, disruptive behavior, a confirmed antecedent to service use. The GBG was tested in a randomized field trial in 19 elementary schools in two cohorts of children as they attended first and second grades. This article reports on the impact of the GBG on service use through young adulthood. Methods Three or four schools in each of five urban areas were matched and randomly assigned to one of three conditions: 1) GBG, 2) an intervention aimed at academic achievement, or 3) the standard program of the school system. Children were assigned to classrooms to ensure balance, and teachers and classrooms were randomly assigned to intervention conditions. Results This study provides evidence of a positive impact of a universal preventive intervention on later service use by males, although not by females, for problems with emotions, behavior, or drugs or alcohol. For both cohorts, males in GBG classrooms who had been rated as highly aggressive, disruptive by their teachers in the fall of first grade had a lower rate of school-based service use than their counterparts in control classrooms. Replication The design employed two cohorts of students. Although both first- and second-grade teachers received less training and support with the second cohorts of students than with the first cohort, the impact of GBG was similar across both cohorts. PMID:18249508

Housing and inequalities in health: a study of socioeconomic dimensions of housing and self reported health from a survey of Vancouver residents

PubMed Central

Dunn, J

2002-01-01

Study objective: To investigate the relation between housing, socioeconomic status, and self reported general and mental health. This study is an empirical investigation of social and economic dimensions of housing, specifically, demand, control, and material (affordability, dwelling type) and meaningful (pride in dwelling, home as a refuge) dimensions of everyday life as they occur in the domestic environment. Design: A cross sectional telephone survey was administered to a random sample of households. Survey items included measures of demand, control, and meaningfulness of the domestic environment, as well as standard measures of socioeconomic status and social support. Main outcome measures were self reported health (excellent, very good, good, fair, poor) and self reported frequency of feeling "downhearted and blue" in the two weeks before interview (from the Rand Mental Health Index). Setting: Households (n=650) from 12 neighbourhood areas in the city of Vancouver, Canada. Participants: One randomly selected adult from each of 650 households completed the interview and constitute the sample for this study. Main results: In bivariate analyses, measures of housing demand, control and meaningfulness exhibited strong and significantly graded relations with self reported health and somewhat less strong relations with mental health. In logistic regression analyses housing demand and control variables made significant contributions to health both general and mental health. Respondents were more likely to report fair/poor health if they: reported that they couldn't stand to be at home sometimes (OR=2.29, p<0.05); rated their domestic housework as somewhat or quite a strain (OR=5.71, p<0.001); were somewhat or very dissatisfied with their social activities (OR=3.41, p<0.001); and reported that they were constantly under stress a good bit of the time or more (OR=3.56, p<0.05). In terms of mental health, respondents were more likely to report poorer mental health if they: lived longer in their neighbourhood (OR=1.05, p<0.05); reported their housework duties to be somewhat or quite a strain (OR=5.55, p<0.001); reported that they did not have somebody that could help them if they needed it (OR=9.28, p<0.001); and reported that they were constantly under stress a good bit of the time or more in the two weeks before the interview (OR=5.26, p<0.001). One of the main hypotheses investigated—that meaningful dimensions of housing are associated with health status—found support in bivariate analyses without controls, but did not contribute to multivariable models. Conclusions: The influence of housing demand and control variables superseded a well known correlate of health status, educational attainment, attesting to their importance. The findings of this paper lend support to the hypothesis that features of the domestic environment, especially as they pertain to the exercise of control and the experience of demand, are significant predictors of self reported general and mental health status. Housing is a concrete manifestation of socioeconomic status, which has an important part to play in the development of explanations of the social production of health inequalities. PMID:12177083

Eggs in Early Complementary Feeding and Child Growth: A Randomized Controlled Trial.

PubMed

Iannotti, Lora L; Lutter, Chessa K; Stewart, Christine P; Gallegos Riofrío, Carlos Andres; Malo, Carla; Reinhart, Gregory; Palacios, Ana; Karp, Celia; Chapnick, Melissa; Cox, Katherine; Waters, William F

2017-07-01

Eggs are a good source of nutrients for growth and development. We hypothesized that introducing eggs early during complementary feeding would improve child nutrition. A randomized controlled trial was conducted in Cotopaxi Province, Ecuador, from March to December 2015. Children ages 6 to 9 months were randomly assigned to treatment (1 egg per day for 6 months [ n = 83]) and control (no intervention [ n = 80]) groups. Both arms received social marketing messages to encourage participation in the Lulun Project ( lulun meaning "egg" in Kichwa). All households were visited once per week to monitor morbidity symptoms, distribute eggs, and monitor egg intakes (for egg group only). Baseline and end point outcome measures included anthropometry, dietary intake frequencies, and morbidity symptoms. Mothers or other caregivers reported no allergic reactions to the eggs. Generalized linear regression modeling showed the egg intervention increased length-for-age z score by 0.63 (95% confidence interval [CI], 0.38-0.88) and weight-for-age z score by 0.61 (95% CI, 0.45-0.77). Log-binomial models with robust Poisson indicated a reduced prevalence of stunting by 47% (prevalence ratio [PR], 0.53; 95% CI, 0.37-0.77) and underweight by 74% (PR, 0.26; 95% CI, 0.10-0.70). Children in the treatment group had higher dietary intakes of eggs (PR, 1.57; 95% CI, 1.28-1.92) and reduced intake of sugar-sweetened foods (PR, 0.71; 95% CI, 0.51-0.97) compared with control. The findings supported our hypothesis that early introduction of eggs significantly improved growth in young children. Generally accessible to vulnerable groups, eggs have the potential to contribute to global targets to reduce stunting. Copyright © 2017 by the American Academy of Pediatrics.

Evaluation of a “Just-in-Time” Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial

PubMed Central

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Context Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. Objective To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Design Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Main Outcome Measures Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Results Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p < 0.01), osteoporosis knowledge (p = 0.04), activation (p < 0.01), dietary self-efficacy (p = 0.06), and osteoporosis care satisfaction (p < 0.01). Compared with PAADRN intervention participants (n = 39), nurse consultation participants had improved dietary self-efficacy (p = 0.07) and osteoporosis care satisfaction (p = 0.05). No significant improvements in osteoporosis-related outcomes were achieved vs PAADRN controls (n = 70). Conclusion “Just-in-time” nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care. PMID:28746019

Effects of combined high-intensity aerobic interval training program and Mediterranean diet recommendations after myocardial infarction (INTERFARCT Project): study protocol for a randomized controlled trial.

PubMed

Maldonado-Martín, Sara; Jayo-Montoya, Jon Ander; Matajira-Chia, Tatiana; Villar-Zabala, Beatriz; Goiriena, Juan José; Aispuru, G Rodrigo

2018-03-02

Exercise therapy has long been used for rehabilitation purposes after myocardial infarction (MI) and the benefit of regular physical exercise is also well-established. High-intensity interval training (HIIT) has been proposed to be more effective than continuous exercise for improving exercise capacity and health-related adaptations to low-volume (LV) and HIIT are also known. Furthermore, the Mediterranean diet (Mediet) has been widely reported to be a model of healthy eating for its contribution to a favorable health status and a better quality of life, reducing overall mortality. This study will investigate the effects of different HIIT programs (high-volume [HV] vs LV) and Mediet recommendations in clinical condition, cardiorespiratory fitness, biomarkers, ventricular function, and perception of quality of life after MI, and compared to an attention control group that is recommended to Mediet and physical activity without supervision sessions. In this randomized controlled trial, cardiorespiratory fitness, anthropometry, central and peripheral cardiovascular variables, biochemical and nutritional condition, and quality of life will be assessed before and after 16 weeks of intervention in 177 participants diagnosed with MI type 1. All participants will be randomly (1:1:1) assigned to the attention control group or two exercise groups (Mediet recommendations plus supervised aerobic exercise two days/week: (1) HV (40 min) HIIT group and (2) LV (20 min) HIIT group. This study will be the first clinical trial comparing the effects of two different volumes of HIIT programs with Mediet recommendations for people after MI. The results of this study will provide good evidence for physical rehabilitation in this population. ClinicalTrials.gov, NCT02876952 . Registered on 24 August 2016.

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].

How to design and write a clinical research protocol in Cosmetic Dermatology*

PubMed Central

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

Human cooperation by lethal group competition.

PubMed

Egas, Martijn; Kats, Ralph; van der Sar, Xander; Reuben, Ernesto; Sabelis, Maurice W

2013-01-01

Why humans are prone to cooperate puzzles biologists, psychologists and economists alike. Between-group conflict has been hypothesized to drive within-group cooperation. However, such conflicts did not have lasting effects in laboratory experiments, because they were about luxury goods, not needed for survival ("looting"). Here, we find within-group cooperation to last when between-group conflict is implemented as "all-out war" (eliminating the weakest groups). Human subjects invested in helping group members to avoid having the lowest collective pay-off, whereas they failed to cooperate in control treatments with random group elimination or with no subdivision in groups. When the game was repeated, experience was found to promote helping. Thus, not within-group interactions alone, not random group elimination, but pay-off-dependent group elimination was found to drive within-group cooperation in our experiment. We suggest that some forms of human cooperation are maintained by multi-level selection: reciprocity within groups and lethal competition among groups acting together.

Why the evidence for outpatient commitment is good enough.

PubMed

Swanson, Jeffrey W; Swartz, Marvin S

2014-06-01

After nearly three decades of studies evaluating the legal practice of involuntary outpatient commitment, there is yet little consensus about its effectiveness and only limited implementation. Debate continues over how best to assist adults with serious mental illnesses who are unable or unwilling to participate in prescribed community treatment and as a result experience repeated involuntary hospitalizations or involvement with the criminal justice system. The authors comment on the Oxford Community Treatment Order Evaluation Trial (OCTET), a recently conducted randomized trial of outpatient commitment, and discuss the limitations of the study's design for resolving the persistent question of whether compulsory treatment is more effective than purely voluntary treatment for this difficult-to-reach target population. The authors conclude that the search for a definitive and generalizable randomized trial of outpatient commitment may be a quixotic quest; the field should, rather, welcome the results of well-conducted, large-scale, quasi-experimental and naturalistic studies with rigorous multivariable statistical controls.

The Effects of Kangaroo Mother Care and Swaddling on Venipuncture Pain in Premature Neonates: A Randomized Clinical Trial.

PubMed

Dezhdar, Shahin; Jahanpour, Faezeh; Firouz Bakht, Saeedeh; Ostovar, Afshin

2016-04-01

Hospitalized premature babies often undergo various painful procedures. Kangaroo mother care (KMC) and swaddling are two pain reduction methods. This study was undertaken to compare the effects of swaddling and KMC on pain during venous sampling in premature neonates. This study was performed as a randomized clinical trial on 90 premature neonates. The neonates were divided into three groups using a random allocation block. The three groups were group A (swaddling), group B (KMC), and group C (control). In all three groups, the heart rate and arterial oxygen saturation were measured and recorded in time intervals of 30 seconds before, during, and 30, 60, 90, and 120 seconds after blood sampling. The neonate's face was video recorded and assessed using the premature infant pain profile (PIPP) at time intervals of 30 seconds. The data was analyzed using the t-test, chi-square test, Repeated Measure analysis of variance (ANOVA), Kruskal-Wallis, Post-hoc, and Bonferroni test. The findings revealed that pain was reduced to a great extent in the swaddling and KMC methods compared to the control group. However, there was no significant difference between KMC and swaddling (P ≥ 0.05). The results of this study indicate that there is no meaningful difference between swaddling and KMC on physiological indexes and pain in neonates. Therefore, the swaddling method may be a good substitute for KMC.

Methodological and ethical aspects of randomized controlled clinical trials in minors with malignant diseases.

PubMed

Rothenberger, Lillian G; Henschel, Andreas Dirk; Schrey, Dominik; Becker, Andreas; Boos, Joachim

2011-10-01

Due to the new European regulations for pediatric medications, future clinical trials will include an increasing number of minors. It is therefore important to reconsider and evaluate recent methodological and ethical aspects of clinical trials in minors. The following questions were investigated: How are randomized controlled clinical trials (RCTs) performed in practice? Do investigators take into consideration biomedical ethical principles, explicated for example by Beauchamp and Childress, when planning and conducting a trial? The study was conducted in a descriptive manner. A systematic, algorithm-guided search focusing on RCTs in minors with malignant diseases was carried out in PubMed. One-thousand-nine-hundred-sixty-two publications from 2001 to 2005 were randomized in sequence. The first 1,000 publications were screened according to a priori defined inclusion criteria. One hundred seventy-five publications met the criteria and were reviewed using the SIGN methodological checklist (2004), the CONSORT Statement (2001, section Methods, items 3-12) and indicators for ethical aspects. Seventeen publications were checked by two raters. Information on randomization and blinding was often equivocal. The publications were mainly rated positive for the criteria of the SIGN checklist, and mostly rated negative for the additional items of the CONSORT Statement. Regarding the ethical principles, only few contributions were found in the publications. Inter-rater reliability was good. In the publications analyzed, we found only limited information concerning methods and reflections on ethical principles of the trials. Improvements are thus necessary and possible. We suggest how such trials and their respective publications can be optimized for these aspects. Copyright © 2011 Wiley-Liss, Inc.

Random and externally controlled occurrences of Dansgaard-Oeschger events

NASA Astrophysics Data System (ADS)

Lohmann, Johannes; Ditlevsen, Peter D.

2018-05-01

Dansgaard-Oeschger (DO) events constitute the most pronounced mode of centennial to millennial climate variability of the last glacial period. Since their discovery, many decades of research have been devoted to understand the origin and nature of these rapid climate shifts. In recent years, a number of studies have appeared that report emergence of DO-type variability in fully coupled general circulation models via different mechanisms. These mechanisms result in the occurrence of DO events at varying degrees of regularity, ranging from periodic to random. When examining the full sequence of DO events as captured in the North Greenland Ice Core Project (NGRIP) ice core record, one can observe high irregularity in the timing of individual events at any stage within the last glacial period. In addition to the prevailing irregularity, certain properties of the DO event sequence, such as the average event frequency or the relative distribution of cold versus warm periods, appear to be changing throughout the glacial. By using statistical hypothesis tests on simple event models, we investigate whether the observed event sequence may have been generated by stationary random processes or rather was strongly modulated by external factors. We find that the sequence of DO warming events is consistent with a stationary random process, whereas dividing the event sequence into warming and cooling events leads to inconsistency with two independent event processes. As we include external forcing, we find a particularly good fit to the observed DO sequence in a model where the average residence time in warm periods are controlled by global ice volume and cold periods by boreal summer insolation.

Double-blind randomized controlled trial comparing misoprostol and oxytocin for management of the third stage of labor in a Nigerian hospital.

PubMed

Musa, Abdulkarim O; Ijaiya, Munir'deen A; Saidu, Rakiya; Aboyeji, Abiodun P; Jimoh, Abiodun A; Adesina, Kikelomo T; Abdul, Ishaq F

2015-06-01

To compare the efficacy of oral misoprostol with that of oxytocin for active management of the third stage of labor (AMTSL). A double-blind randomized control trial was undertaken at a center in Ilorin, Nigeria, between January and June 2013. Every other eligible patient (in the first stage of labor at term, to have a spontaneous vaginal delivery, and no/low risk of postpartum hemorrhage [PPH]) were randomly assigned with computer-generated random numbers to receive oral misoprostol (600μg) plus placebo injection or oral placebo plus oxytocin injection (1mL of 10IU) in the third stage of labor. The primary outcome was amount of blood loss during delivery. Mean postpartum blood loss was 325.85±164.72mL in the 100 patients given misoprostol and 303.95±163.33mL in the 100 patients given oxytocin (P=0.391). PPH (≥500mL blood loss) was recorded in 15 (15.0%) patients given misoprostol and 14 (14.0%) given oxytocin (P=0.841). Shivering, pyrexia, and diarrhea were all significantly more common in the misoprostol group (P<0.01 for all). The efficacy of oral misoprostol was similar to that of intramuscular oxytocin. Adverse effects associated with misoprostol were transient and self-limiting. Thus, oral misoprostol is efficacious and a good alternative to oxytocin for AMTSL. Pan African Clinical Trials Registry:PACTR201407000825227. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight.

PubMed

Hair, Amy B; Blanco, Cynthia L; Moreira, Alvaro G; Hawthorne, Keli M; Lee, Martin L; Rechtman, David J; Abrams, Steven A

2014-11-01

To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control). In a prospective noninferiority, randomized, unmasked study, infants with a birth weight 750-1250 g were randomly assigned to the control or cream group. The control group received mother's own milk or donor HM with donor HM-derived fortifier. The cream group received a HM-derived cream supplement if the energy density of the HM tested <20 kcal/oz using a near infrared HM analyzer. Infants were continued on the protocol until 36 weeks postmenstrual age. Primary outcomes included growth velocities and amount of donor HM-derived fortifier used. The hypothesis of noninferiority was established if the lower bound of the one-sided 95% CI for the difference in weight velocities exceeded -3 g/kg/day. There were no differences between groups in baseline demographics for the 78 infants studied except racial distribution (P = .02). The cream group (n = 39) had superior weight (14.0 ± 2.5 vs 12.4 ± 3.0 g/kg/d, P = .03) and length (1.03 ± 0.33 vs 0.83 ± 0.41 cm/wk, P = .02) velocity compared with the control group (n = 39). There were no significant differences in amount of fortifier used between study groups. The 1-sided 95% lower bound of the CI for the difference in mean velocity (cream-control) was 0.38 g/kg/d. Premature infants who received HM-derived cream to fortified HM had improved weight and length velocity compared with the control group. HM-derived cream should be considered an adjunctive supplement to an exclusive HM-based diet to improve growth rates in premature infants. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Binomial leap methods for simulating stochastic chemical kinetics.

PubMed

Tian, Tianhai; Burrage, Kevin

2004-12-01

This paper discusses efficient simulation methods for stochastic chemical kinetics. Based on the tau-leap and midpoint tau-leap methods of Gillespie [D. T. Gillespie, J. Chem. Phys. 115, 1716 (2001)], binomial random variables are used in these leap methods rather than Poisson random variables. The motivation for this approach is to improve the efficiency of the Poisson leap methods by using larger stepsizes. Unlike Poisson random variables whose range of sample values is from zero to infinity, binomial random variables have a finite range of sample values. This probabilistic property has been used to restrict possible reaction numbers and to avoid negative molecular numbers in stochastic simulations when larger stepsize is used. In this approach a binomial random variable is defined for a single reaction channel in order to keep the reaction number of this channel below the numbers of molecules that undergo this reaction channel. A sampling technique is also designed for the total reaction number of a reactant species that undergoes two or more reaction channels. Samples for the total reaction number are not greater than the molecular number of this species. In addition, probability properties of the binomial random variables provide stepsize conditions for restricting reaction numbers in a chosen time interval. These stepsize conditions are important properties of robust leap control strategies. Numerical results indicate that the proposed binomial leap methods can be applied to a wide range of chemical reaction systems with very good accuracy and significant improvement on efficiency over existing approaches. (c) 2004 American Institute of Physics.

Effects of a wearable type lumbosacral support for low back pain among hospital workers: A randomized controlled trial.

PubMed

Hagiwara, Yoshihiro; Yabe, Yutaka; Yamada, Hiroyuki; Watanabe, Takashi; Kanazawa, Kenji; Koide, Masashi; Sekiguchi, Takuya; Hatano, Hirokazu; Itoi, Eiji

2017-03-28

To examine the effects of a new wearable type of lumbosacral support on low back pain. A total of 121 healthcare workers participated in this study. They were randomly allocated into the experimental and control groups and the former wore the support with signals of compression on the back by poor posture for the first 3 months. The control group remained on a waiting list for the first 3 months. Medical history, musculoskeletal symptoms, feeling in good posture, sleep habits, psychological distress, Roland-Morris Disability Questionnaire, and Somatosensory Amplification Scale (SSAS) were evaluated. The range of motion (ROM) in the shoulder and hip joints as well as spinal alignment were evaluated. Our primary concern was the difference in the change of low back pain measured by visual analog scale (VAS) between the two groups. A total of 54 participants in the experimental and 53 participants in the control groups were analyzed. VAS and SSAS scores as well as lumbar spinal ROM in the experimental group significantly decreased. Low back pain (OR=0.401, 95% CI=0.168-0.954) and neck pain in the experimental group (OR=0.198, 95% CI=0.052-0.748) significantly decreased. The new lumbar support reduced VAS and SSAS scores, lumbar spinal ROM, low back pain, and neck pain. This new type of lumbar support reduced low back pain among healthcare workers.

Endoscopic and laparoscopic treatment of gastroesophageal reflux.

PubMed

Watson, David I; Immanuel, Arul

2010-04-01

Gastroesophageal reflux is extremely common in Western countries. For selected patients, there is an established role for the surgical treatment of reflux, and possibly an emerging role for endoscopic antireflux procedures. Randomized trials have compared medical versus surgical management, laparoscopic versus open surgery and partial versus total fundoplications. However, the evidence base for endoscopic procedures is limited to some small sham-controlled studies, and cohort studies with short-term follow-up. Laparoscopic fundoplication has been shown to be an effective antireflux operation. It facilitates quicker convalescence and is associated with fewer complications, but has a similar longer term outcome compared with open antireflux surgery. In most randomized trials, antireflux surgery achieves at least as good control of reflux as medical therapy, and these studies support a wider application of surgery for the treatment of moderate-to-severe reflux. Laparoscopic partial fundoplication is an effective surgical procedure with fewer side effects, and it may achieve high rates of patient satisfaction at late follow-up. Many of the early endoscopic antireflux procedures have failed to achieve effective reflux control, and they have been withdrawn from the market. Newer procedures have the potential to fashion a surgical fundoplication. However, at present there is insufficient evidence to establish the safety and efficacy of endoscopic procedures for the treatment of gastroesophageal reflux, and no endoscopic procedure has achieved equivalent reflux control to that achieved by surgical fundoplication.

Itopride therapy for functional dyspepsia: a meta-analysis.

PubMed

Huang, Xuan; Lv, Bin; Zhang, Shuo; Fan, Yi-Hong; Meng, Li-Na

2012-12-28

To evaluate the therapeutic effects of itopride vs other drugs (placebo, domperidone, mosapride) for functional dyspepsia (FD). Randomized controlled trials (RCTs) of itopride for FD were retrieved from databases. Relevant information was extracted and analyzed, using the relative risk (RR) and weighted mean deviation, as appropriate. A random or fixed effect model was used, based on the heterogeneity of the included articles, and visual inspection of funnel plots was used to evaluate publication bias. Nine RCTs enrolling 2620 FD cases were included; 1372 cases received itopride treatment and 1248 cases received placebo or other drugs (control groups). Compared with control groups, itopride had superior RR values of 1.11 [95%CI: (1.03, 1.19), P = 0.006], 1.21 [95%CI: (1.03, 1.44), P = 0.02], and 1.24 [95%CI: (1.01, 1.53), P = 0.04] for global patient assessment, postprandial fullness, and early satiety, respectively. For the Leeds Dyspepsia Questionnaire score, the weighted mean deviation was -1.38 [95%CI: (-1.75, -1.01), P < 0.01]. The incidence of adverse effects was similar in the itopride and control groups. The funnel plots for all indicators showed no evidence of publication bias. Itopride has good efficacy in terms of global patients assessment, postprandial fullness, and early satiety in the treatment of patients with FD and shows a low rate of adverse reactions. Itopride can greatly improve FD syndromes-score.

Mean deviation coupling synchronous control for multiple motors via second-order adaptive sliding mode control.

PubMed

Li, Lebao; Sun, Lingling; Zhang, Shengzhou

2016-05-01

A new mean deviation coupling synchronization control strategy is developed for multiple motor control systems, which can guarantee the synchronization performance of multiple motor control systems and reduce complexity of the control structure with the increasing number of motors. The mean deviation coupling synchronization control architecture combining second-order adaptive sliding mode control (SOASMC) approach is proposed, which can improve synchronization control precision of multiple motor control systems and make speed tracking errors, mean speed errors of each motor and speed synchronization errors converge to zero rapidly. The proposed control scheme is robustness to parameter variations and random external disturbances and can alleviate the chattering phenomena. Moreover, an adaptive law is employed to estimate the unknown bound of uncertainty, which is obtained in the sense of Lyapunov stability theorem to minimize the control effort. Performance comparisons with master-slave control, relative coupling control, ring coupling control, conventional PI control and SMC are investigated on a four-motor synchronization control system. Extensive comparative results are given to shown the good performance of the proposed control scheme. Copyright © 2016 ISA. Published by Elsevier Ltd. All rights reserved.

Efficacy of early physical therapy in severe Bell's palsy: a randomized controlled trial.

PubMed

Nicastri, Maria; Mancini, Patrizia; De Seta, Daniele; Bertoli, Gianantonio; Prosperini, Luca; Toni, Danilo; Inghilleri, Maurizio; Filipo, Roberto

2013-01-01

Bell's palsy (BP) is the most frequent form of peripheral palsy of the facial nerve. Prognosis for recovery is good for most patients; in the remaining cases, different grades of residual impairment persist. Physical therapy, in association with drug administration, aims to improve outcomes. To assess the efficacy of early physical therapy in association with standard drug administration versus pharmacological therapy only, in terms of time to maximum gains and grade of recovery of function, and to examine who will most benefit from rehabilitation. From June 2008 to May 2010, 232 individuals were evaluated. The 87 patients meeting the eligibility criteria were randomly assigned to the experimental group (prednisone and valacyclovir plus physical therapy, n = 39) or the control group (pharmacological therapy, n = 48) within 10 days of onset. Intention-to-treat analyses were done. The physical therapy had a significant effect on grade (P = .038) and time (P = .044) to recovery only in patients presenting with severe facial palsy (House-Brackmann [HB] grade V/VI). No significant differences were found between the study and control groups for outcome of synkinesis. Physical therapy appears to be effective only in the more severe BP (baseline HB grade V/VI), whereas less severe BP (baseline HB grade IV) results in complete spontaneous recovery, regardless of physical therapy.

Factors influencing hand washing behaviour in primary schools: process evaluation within a randomized controlled trial.

PubMed

Chittleborough, Catherine R; Nicholson, Alexandra L; Basker, Elaine; Bell, Sarah; Campbell, Rona

2012-12-01

This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57). Pupils and staff in intervention and control schools demonstrated a similar level of understanding of how, when and why they should wash their hands. Lack of time, poor adult modelling of regular hand washing and unattractive facilities were seen as important barriers to regular hand washing. Reminders and explanations for the importance of hand hygiene were thought to have a positive impact. Influencing individual choices about hand washing through education and information may be necessary, but not sufficient, for initiating and maintaining good hand washing practices. Structural factors, including having time to wash hands using accessible, clean facilities, and being encouraged through the existence of hand washing opportunities in the daily routine and hand washing being viewed as the social norm, will also influence hand washing behaviour. The effectiveness of educational interventions at improving hand hygiene in primary schools may be improved by changing priorities of staff and increasing accessibility to quality facilities.

Three-dimensional porous poly-DL-lactide/basic fibroblast growth factor composites for bone defect repair: an experimental study.

PubMed

Min, Shao-xiong; Jin, An-min; Tong, Bin-hui; Zhu, Li-xin; Tian, Jing

2003-04-01

To investigate the osteoinductive ability of the composites consisting of basic fibroblast growth factor (bFGF) and porous poly-DL-lactide (PDLLA) for the development of a new absorbable osteosynthesis material. Highly porous foams of PDLLA with the pore size ranging from 150 to 300 microm were prepared by a solvent-casting, particulate-leaching technique with NaCl as the leachable component. Animal models of radial diaphyseal defects of 1.0 cm with complete removal of the periosteum were induced in 45 rabbits, which were randomly divided into 3 groups to receive the defect repair with PDLLA and PDLLA/bFGF respectively, leaving one group untreated to serve as the control group. The implant specimens were harvested at 2, 4, 8, and 12 weeks respectively after the surgery and X-ray, histological and scanning electron microscopic (SEM) examinations were performed to evaluate the effectiveness of defect repair. At 8 and 12 weeks after implantation, biomechanical test (for three-point bending strength) was employed to study the quality of bone formation. PDLLA/bFGF composite stimulated more bone formation and had higher bending strength than PDLLA (P<0.05), and the bone formation induced by both materials was significantly more than that observed in the control group in every postoperative stage (P<0.05). PDLLA possesses good biocompatibility and absorbability, and when prepared into a porous material, it exhibits good osteoconductibility. As a good bFGF carrier, the foam of PDLLA with three- dimensional structure shows good osteoinductive ability with regard to the rapidity, quantity and quality of the bone formation.

How Do School-Based Prevention Programs Impact Teachers? Findings from a Randomized Trial of an Integrated Classroom Management and Social-Emotional Program.

PubMed

Domitrovich, Celene E; Bradshaw, Catherine P; Berg, Juliette K; Pas, Elise T; Becker, Kimberly D; Musci, Rashelle; Embry, Dennis D; Ialongo, Nicholas

2016-04-01

A number of classroom-based interventions have been developed to improve social and behavioral outcomes for students, yet few studies have examined how these programs impact the teachers who are implementing them. Impacts on teachers may affect students and therefore also serve as an important proximal outcome to examine. The current study draws upon data from a school-based randomized controlled trial testing the impact of two prevention programs. In one intervention condition, teachers were trained in the classroom behavior management program, PAX Good Behavior Game (PAX GBG). In a second intervention condition, teachers were trained to use an integrated program, referred to as PATHS to PAX, of the PAX GBG and a social and emotional learning curriculum called Promoting Alternative Thinking Strategies (PATHS©). This study aimed to determine whether both interventions positively impacted teachers, with a particular interest in the teachers' own beliefs and perceptions regarding self-efficacy, burnout, and social-emotional competence. The sample included 350 K-5 teachers across 27 schools (18 schools randomized to intervention, 9 to control). Multilevel latent growth curve analyses indicated that the PATHS to PAX condition generally demonstrated the most benefits to teachers, relative to both the control and PAX GBG conditions. These findings suggest that school-based preventive interventions can have a positive impact on teachers' beliefs and perceptions, particularly when the program includes a social-emotional component. Several possible mechanisms might account for the added benefit to teachers. Additional research is needed to better understand how these programs impact teachers, as well as students.

Self-efficacy is associated with increased food security in novel food pantry program.

PubMed

Martin, Katie S; Colantonio, Angela G; Picho, Katherine; Boyle, Katie E

2016-12-01

We examined the effect of a novel food pantry intervention (Freshplace) that includes client-choice and motivational interviewing on self-efficacy and food security in food pantry clients. The study was designed as a randomized control trial. Participants were recruited over one year from traditional food pantries in Hartford, CT. Participants were randomized to Freshplace or traditional food pantries (controls) and data collection occurred at baseline with quarterly follow-ups for 18 months. Food security was measured using the USDA 18-item Food Security Module. A newly developed scale was utilized to measure self-efficacy. Scale reliability was measured using a Cronbach alpha test; validity was measured via correlating with a related variable. Analyses included chi-square tests for bivariate analyses and hierarchical linear modeling for longitudinal analyses. A total of 227 adults were randomized to the Freshplace intervention ( n =112) or control group ( n =115). The overall group was 60% female, 73% Black, mean age=51. The new self-efficacy scale showed good reliability and validity. Self-efficacy was significantly inversely associated with very low food security ( p <.05). Being in the Freshplace intervention ( p =.01) and higher self-efficacy ( p =.04) were independently associated with decreased very low food security. The traditional food pantry model fails to recognize the influence of self-efficacy on a person's food security. A food pantry model with client-choice, motivational interviewing and targeted referral services can increase self-efficacy of clients. Prioritizing the self-efficacy of clients over the efficiency of pantry operations is required to increase food security among disadvantaged populations.

[Tolerance and adequacy of a 100% lactose infant formula. A controlled randomized double-blind study].

PubMed

Girardet, J-P; Fournier, V; Bakhache, P; Beck, L; Kempf, C; Lachambre, E

2012-07-01

Lactose has beneficial nutritional effects in infancy, particularly on calcium retention and on Bifidobacterium colon microflora development. The objective of this controlled, prospective, randomized double-blind study was to assess the adequacy and safety of an infant formula containing only lactose as carbohydrate, as compared to a usual formula. Healthy non-breast-fed infants aged under 7 days were randomized to be fed exclusively with a conventional formula containing lactose (9.6 g/100 kcal) and maltodextrin (1.6 g/100 kcal) or the isocaloric-isoprotein study formula containing 100% lactose (11.2 g/100 kcal) for 120 days. Primary outcome was daily weight gain at D0 and D120. Weight, length, body mass index, formula consumption, tolerance, and safety were assessed monthly. The non-inferiority of the study formula was rejected if the difference in weight gain was higher than 2.5 g/day in the control group. One hundred and seventy-eight infants were enrolled. Mean daily weight gain in the study group differed by 0.71 g/day (95% CI: -2.23; 0.82) indicating the non-inferiority of the study formula. Growth was normal and similar in the two groups, but formula intake was decreased in the study group, leading to a decrease in energy and protein intakes. Tolerance was good and adverse events did not differ between the two groups. The 100% lactose study infant formula was safe and non-inferior to a conventional formula in ensuring normal growth during the first 4 months of life. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

[Effectiveness of the transparent sterile dressing vs standard to fix the peripheral venous catheter (PVC) on the incidence of phlebitis. A randomized controlled trial].

PubMed

Forni, Cristiana; D'Alessandro, Fabio; Gambino, Orazio; Amodeo, Alfredo; Pignotti, Elettra; Zanotti, Enrichetta; Tremosini, Morena; Trofa, Carmela; Sabattini, Tania; Matino, Federica; Genco, Rossana; Schiavone, Miguel; Bombino, Caterina; Mini, Sandra; Rocchegiani, Laura; Notarnicola, Teresa; Capezzali, Daniela; Boschi, Rita; Loro, Loretta

2012-01-01

Effectiveness of the transparent sterile dressing vs standard to fix the peripheral venous catheter (PVC), on the incidence of phlebitis. A randomized controlled trial. The type of dressing could contribute to the incidence of phlebitis, infiltration and accidental removals but the results of the studies are contrasting and samples are limited. To compare the effectiveness of a transparent polyurethane sterile dressing on the rate of phlebitis associated to peripheral venous catheter (PVC) vs a non sterile sticking plaster in use in current practice (standard dressing). Randomized controlled trial. Participants. 1061 PVCs (703 patients, adults and children) at a research orthopedic hospital in the north of Italy; 540 PVCs allocated to receive the sterile and 521 the standard dressing. 96 PVCs were excluded for phlebitis, 48 (9.6%) in the sterile and 48 (10.1%) in the standard dressing group, RR 0.96 (95%CI 0.697 - 1.335). Accidental removal of the PVCs was more frequent with the sterile dressing (9.6% vs 6.3%) but the number of catheters removed without complications was larger in the standard dressing group (48.9% vs 54.9% P=0.0503). Eighty-five PVCs were replaced for detachment of the dressing (50, 9.2% sterile and 35, 6.7% standard dressing). The cheapest transparent sterile dressing costs 32 cents while the standard 9 cents. A sticking non sterile plasters is not influential on the rate of phlebitis and ensures an good fix of the PVC compared the transparent sterile dressing to of polyurethane film.

Error analysis and algorithm implementation for an improved optical-electric tracking device based on MEMS

NASA Astrophysics Data System (ADS)

Sun, Hong; Wu, Qian-zhong

2013-09-01

In order to improve the precision of optical-electric tracking device, proposing a kind of improved optical-electric tracking device based on MEMS, in allusion to the tracking error of gyroscope senor and the random drift, According to the principles of time series analysis of random sequence, establish AR model of gyro random error based on Kalman filter algorithm, then the output signals of gyro are multiple filtered with Kalman filter. And use ARM as micro controller servo motor is controlled by fuzzy PID full closed loop control algorithm, and add advanced correction and feed-forward links to improve response lag of angle input, Free-forward can make output perfectly follow input. The function of lead compensation link is to shorten the response of input signals, so as to reduce errors. Use the wireless video monitor module and remote monitoring software (Visual Basic 6.0) to monitor servo motor state in real time, the video monitor module gathers video signals, and the wireless video module will sent these signals to upper computer, so that show the motor running state in the window of Visual Basic 6.0. At the same time, take a detailed analysis to the main error source. Through the quantitative analysis of the errors from bandwidth and gyro sensor, it makes the proportion of each error in the whole error more intuitive, consequently, decrease the error of the system. Through the simulation and experiment results shows the system has good following characteristic, and it is very valuable for engineering application.

The Role of Bolus Injection of Saline with Arm Elevation on Rocuronium onset Time: A Randomized Control Study

PubMed Central

Kulkarni, Malavika; Chuchendra, L. S.; Bhavya, P. J.

2018-01-01

Background: The onset time of neuromuscular blockade is a crucial time associated with the risk of hypoxia and pulmonary aspiration. Various strategies have been undertaken to shorten this onset time. Therefore, we investigated the effects of bolus of 20 ml saline followed by limb elevation after administration of rocuronium in a dose of 0.6 mg/kg to study the onset time. Methodology: Thirty patients were randomly allocated to the bolus saline group or control group. General anesthesia was induced and maintained with fentanyl and propofol. Rocuronium 0.6 mg/kg intravenous (IV) was administered followed by 20 ml saline bolus and limb elevation in the study group compared to administration of 0.6 mg/kg in a running drip only in the control. Onset of neuromuscular block was assessed by acceleromyography at the adductor pollicis muscle with train-of-four stimulation. Results: The lag time was shorter in bolus group (34 s median) than in control group (45 s median), P < 0.017. The onset time was shorter in bolus group (55 s median) than in control group (110 s median), P < 0.001. The T1 recovery to 25% was longer in bolus group (42 min median) than in control group (39 min median) which was statistically not significant. Conclusion: Rocuronium 0.6 mg/kg IV followed by bolus 20 ml saline and concomitant limb elevation resulted in shorter lag time, faster onset of neuromuscular blockade, good intubating conditions without prolonging clinical duration of action when compared to the control. PMID:29628555

Knowledge and Preventive Practices related to Avian Influenza among Poultry Workers of Kamalamai Municipality, Sindhuli, Nepal.

PubMed

Shrestha, R; Shrestha, K B; Ghimire, S; Shrestha, N

2016-01-01

Avian influenza (AI) is currently a threat to global health. Prevention and control of AI depends on the knowledge and preventive practices of the poultry workers as well as of general population. This study aims to assess knowledge and preventive practices related to AI among poultry workers. Cross-sectional study was carried out among poultry workers of Kamalamai Municipality, Sindhuli. Data was collected from randomly selected 122 respondents through face-to-face interview. The collected data was entered in Epi-data version 3.1 and analyzed in terms of descriptive statistics (proportion, 95% CI, mean and standard deviation) by using SPSS, version 20. A scoring system was used to assess knowledge and preventive practices. Out of total, 93.4% (95% CI, 87.6- 96.6%) of the respondents had heard about AI. More than half (54.9%) of the respondents had poor knowledge on AI. Only 5.3% of respondents had good preventive practice against AI. 30.3% respondents had good knowledge and good practice and 24.6% had poor knowledge as well as poor practice. 20.5% of the respondents had good practice but poor knowledge, whereas, 24.6% had good knowledge but poor practice towards prevention. The knowledge and practice of AI among poultry workers were low. The groups should be targeted for appropriate intervention based on whether they lack knowledge or practice or both.

Effect of Breathing Technique of Blowing on the Extent of Damage to the Perineum at the Moment of Delivery: A Randomized Clinical Trial

PubMed Central

Ahmadi, Zohre; Torkzahrani, Shahnaz; Roosta, Firouze; Shakeri, Nezhat; Mhmoodi, Zohre

2017-01-01

Introduction: One of the important tasks in managing labor is the protection of perineum. An important variable affecting this outcome is maternal pushing during the second stage of labor. This study was done to investigate the effect of breathing technique on perineal damage extention in laboring Iranian women. Materials and Methods: This randomized clinical trial was performed on 166 nulliparous pregnant women who had reached full-term pregnancy, had low risk pregnancy, and were candidates for vaginal delivery in two following groups: using breathing techniques (case group) and valsalva maneuver (control group). In the control group, pushing was done with holding the breath. In the case group, the women were asked to take 2 deep abdominal breaths at the onset of pain, then take another deep breath, and push 4–5 seconds with the open mouth while controlling exhalation. From the crowning stage onward, the women were directed to control their pushing, and do the blowing technique. Results: According to the results, intact perineum was more observed in the case group (P = 0.002). Posterior tears (Grade 1, 2, and 3) was considerably higher in the control group (P = 0.003). Anterior tears (labias) and episiotomy were not significantly different in the two groups. Conclusions: It was concluded that breathing technique of blowing can be a good alternative to Valsalva maneuver in order to reduce perineal damage in laboring women. PMID:28382061

[Effect of oral administration of probiotics on intestinal colonization with drug-resistant bacteria in preterm infants].

PubMed

Hua, Xin-Tian; Tang, Jun; Mu, De-Zhi

2014-06-01

To evaluate the effect of oral administration of probiotics on intestinal colonization with drug-resistant bacteria among preterm infants in the neonatal intensive care unit (NICU). A double-blind, randomized, placebo-controlled trial was carried out in the preterm infants who were transferred to the NICU immediately after birth. These infants were stratified by whether they were breastfed and then randomized into test group and control group. The test group was given probiotics from the day when enteral feeding began, while the control group was treated conventionally without probiotics. The two groups were compared in terms of the colonization with extended-spectrum beta-lactamase-producing bacteria, as assessed by rectal swabs on days 1, 3, 7, and 14 after birth, and the incidence of diseases. Rectal colonization with drug-resistant bacteria was found in the test group (n=119) and control group (n=138) on days 1, 3, 7, and 14 after birth. There were no significant differences in the incidence of late-onset sepsis and necrotizing enterocolitis between the two groups (P>0.05). Among non-breastfed infants, the test group had significantly decreased rectal colonization with drug-resistant bacteria compared with the control group on day 14 after birth (71.1% vs 88.9%; P=0.04). No probiotic-related adverse events were observed in the study. Oral administration of probiotics may reduce rectal colonization with drug-resistant bacteria in preterm infants under certain conditions and shows good safety.

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

PubMed Central

2014-01-01

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

Reliability of individual valuations of public and private goods: Choice consistency, response time, and preference refinement

Treesearch

Thomas C. Brown; David Kingsley; George L. Peterson; Nicholas E. Flores; Andrea Clarke; Andrej Birjulin

2008-01-01

We examined the reliability of a large set of paired comparison value judgments involving public goods, private goods, and sums of money. As respondents progressed through a random sequence of paired choices they were each given, their response time decreased and they became more consistent, apparently fine-tuning their responses, suggesting that respondents tend to...

Three Doses of an Experimental Detoxified L3-Derived Lipooligosaccharide Meningococcal Vaccine Offer Good Safety but Low Immunogenicity in Healthy Young Adults ▿

PubMed Central

Bonvehí, Pablo; Boutriau, Dominique; Casellas, Javier; Weynants, Vincent; Feron, Christiane; Poolman, Jan

2010-01-01

This open, randomized phase I study evaluated the safety and reactogenicity of an experimental meningococcal serogroup B (MenB) vaccine obtained from outer membrane vesicle detoxified L3-derived lipooligosaccharide. Healthy young adults (n = 150) were randomized to receive either experimental vaccine (provided in five formulations, n = 25 in each group) or VA-Mengoc-BC (control, n = 25) administered on a 0- to 6-week/6-month schedule. Serum bactericidal assays performed against three MenB wild-type strains assessed the immune response, defined as a 4-fold increase from pre- to postvaccination. No serious adverse events related to vaccination were reported. Pain at the injection site, fatigue, and headache were the most commonly reported adverse events. Solicited adverse events graded level 3 (i.e., preventing daily activity) were pain (up to 17% of the test subjects versus 32% of the controls), fatigue (up to 12% of the test subjects versus 8% of the controls), and headache (up to 4% of any group). Swelling graded level 3 (greater than 50 mm) occurred in up to 4% of the test subjects versus 8% of the controls. The immune responses ranged from 5% to 36% across experimental vaccines for the L3 H44-76 strain (versus 27% for the control), from 0% to 11% for the L3 NZ98/124 strain (versus 23% for the control), and from 0% to 13% for the L2 760676 strain (versus 59% for the control). All geometric mean titers were below those measured with the control vaccine. The five experimental formulations were safe and well tolerated but tended to be less immunogenic than the control vaccine. PMID:20660140

Stage-oriented comprehensive acupuncture treatment plus rehabilitation training for apoplectic hemiplegia.

PubMed

Mao, Min; Chen, Xin; Chen, Yuefeng; Rao, Ping; Liu, Jian

2008-06-01

To study the effect of stage-oriented comprehensive acupuncture treatment plus rehabilitation training for the recovery of apoplectic hemiplegia. The 60 cases of acute apoplectic hemiplegia were divided randomly into the treatment and control groups with 30 in each. Based on the routine medication, acupuncture combined with modern rehabilitation techniques was applied for the treatment group, while only rehabilitation treatment for the control group. Before and three months after treatment, the evaluation was done on the motor function and daily life ability for both groups respectively with simplified Fugl-Meyer Evaluation and modified Barthel index. The therapeutic effect of treatment group was significantly superior to that of the control group (P < 0.05). Based on Brunnstrom's theory of six-stage in the recovery of hemiplegia, the effect of stage-oriented comprehensive acupuncture therapy combined with rehabilitation training is very good, helpful in raising the daily life ability of patients.

Predicting Baseline for Analysis of Electricity Pricing

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

Kim, T.; Lee, D.; Choi, J.

2016-05-03

To understand the impact of new pricing structure on residential electricity demands, we need a baseline model that captures every factor other than the new price. The standard baseline is a randomized control group, however, a good control group is hard to design. This motivates us to devlop data-driven approaches. We explored many techniques and designed a strategy, named LTAP, that could predict the hourly usage years ahead. The key challenge in this process is that the daily cycle of electricity demand peaks a few hours after the temperature reaching its peak. Existing methods rely on the lagged variables ofmore » recent past usages to enforce this daily cycle. These methods have trouble making predictions years ahead. LTAP avoids this trouble by assuming the daily usage profile is determined by temperature and other factors. In a comparison against a well-designed control group, LTAP is found to produce accurate predictions.« less

Is the Whipple procedure harmful for long-term outcome in treatment of chronic pancreatitis? 15-years follow-up comparing the outcome after pylorus-preserving pancreatoduodenectomy and Frey procedure in chronic pancreatitis.

PubMed

Bachmann, Kai; Tomkoetter, Lena; Kutup, Asad; Erbes, Johannes; Vashist, Yogesh; Mann, Oliver; Bockhorn, Maximilian; Izbicki, Jakob R

2013-11-01

The aim of this study was to report on 15-year long-term results of a randomized controlled trial comparing extended drainage procedure (Frey) and classical resectional procedure [pylorus-preserving pancreatoduodenectomy (PD)] in patients with chronic pancreatitis. Chronic pancreatitis is a common inflammatory disease with a prevalence of 10 to 30 cases per 100,000 inhabitants. It is characterized by the progressive conversion of pancreatic parenchyma to fibrous tissue. Different surgical procedures are used in treatment of persistent pain. Sixty-four patients suffering from chronic pancreatitis with inflammatory mass in the pancreatic head were randomly assigned in 2 treatment groups (PD, n = 32) and (Frey, n = 32). The perioperative course of the randomized controlled trial and the 7 years follow-up have been previously published. All participating patients were contacted with a standardized, validated questionnaire (EORTC QLQ C30) to evaluate the long-term survival, quality-of-life pain, and exocrine and endocrine function. In the 15-year long-term follow-up, the pain control was good and comparable between both groups, but the quality of life was better after Frey procedure in regard of the physical status [PD: 100 (0-100) vs PD: 60 (0-100) (P = 0.011)]. No significant differences in terms of the Pain Score were detected between both groups [PD: 7 (0-100) vs Frey 4 (0-100) P = 0.258]. Seven patients after Frey OP and 6 patients after PD were free of pain. Analyzing the postoperative overall survival, a higher long-term mortality was found after PD (53%) than that found after Frey procedure (30%) resulting in a longer mean survival (14.5 ± 0.8 vs 11.3 ± 0.8 years; P = 0.037). No correlation between endocrine or exocrine pancreatic function and pain was found, whereas continuous alcohol consumption was associated with poorer outcome regarding quality of life (P < 0.001) and pain score (P < 0.001). PD and Frey procedure provide good and permanent pain relief and improvement of the quality of life in long-term follow-up. In addition, a longer survival was found after the organ sparing resection. Together with better short-term results, the organ-sparing procedure seems to be favorable in treatment of chronic pancreatitis.

PubMed Central

Baillargeon, L.

1997-01-01

OBJECTIVE: To familiarize family physicians with cognitive and behavioural treatments for insomnia. DATA SOURCES: MEDLINE was searched from 1983 to 1995 and Psychlit from 1974 to 1995 using the key words "behaviour therapy," "cognitive therapy," "phototherapy," and "insomnia." STUDY SELECTION: We chose randomized trials and meta-analyses on the treatment of insomnia. Information was extracted on time-lag before sleep, frequency and duration of wakeful periods during the night, consumption of hynotics, and subjects' own assessment of their sleep before and after treatment. SYNTHESIS: The most effective interventions were relaxation training, sleep restriction, and stimulus control. Practising good sleeping habits was only somewhat effective and should always be used in conjunction with other interventions. CONCLUSION: Stimulus control for insomnia has been demonstrated to be effective when used by primary care physicians. Other nonpharmacologic treatments should be evaluated in a similar manner. PMID:9063996

The Relationship Between Mental Health and Social Solidarity Among Apartment Residents in Shahrekord, Iran

PubMed Central

Ganji, Forouzan; Nekooee, Afsaneh; Safdari, Faranak; Parvin, Neda; Shafei, Akbar; Ganji, Hanife

2012-01-01

Objective: To examine the relationship between psychological well-being and social solidarity of apartment residents in Shahrekord, Iran. Methods: A sample of 200 apartment dwellers was selected randomly. Fessler Social Solidarity Inventory and General Health Questionnaire were used to gather data. Results: Using partial correlation test and having controlled the effect of age, sex and education, we found significant relationship between mental health and social solidarity (r = 0.47; p= 0.023). After controlling education and marital status, it was also revealed that women were in a better solidarity situation compared to men (p< 0.05). Conclusion: There is a relation between the mental health and social solidarity of apartment residents in Sharekord. Good mental health accompanied with better social solidarity. PMID:24644465

Effect of an educational intervention in primary care physicians on the compliance of indicators of good clinical practice in the treatment of type 2 diabetes mellitus [OBTEDIGA project].

PubMed

Vidal-Pardo, J I; Pérez-Castro, T R; López-Álvarez, X L; Santiago-Pérez, M I; García-Soidán, F J; Muñiz, J

2013-08-01

To evaluate the effect of an educational intervention among primary care physicians on several indicators of good clinical practice in diabetes care. Two groups of physicians were randomly assigned to the intervention or control group (IG and CG). Every physician randomly selected two samples of patients from all type 2 diabetic patients aged 40 years and above and diagnosed more than a year ago. Baseline and final information were collected cross-sectionally 12 months apart, in two independent samples of 30 patients per physician. The educational intervention comprised: distribution of educational materials and physicians' specific bench-marking information, an on-line course and three on-site educational workshops on diabetes. External observers collected information directly from the physicians and from the medical records of the patients on personal and family history of disease and on the evolution and treatment of their disease. Baseline information was collected retrospectively in the control group. Intervention group comprised 53 physicians who included a total of 3018 patients in the baseline and final evaluations. CG comprised 50 physicians who included 2868 patients in the same evaluations. Measurement of micro-albuminuria in the last 12 months (OR = 1.6, 95% CI: 1.1-2.4) and foot examination in the last year (OR = 2.0, 95% CI: 1.1-3.6) were the indicators for which greater improvement was found in the IG. No other indicator considered showed statistically significant improvement between groups. The identification of indicators with very low level of compliance and the implementation of a simple intervention in physicians to correct them is effective in improving the quality of care of diabetic patients. © 2013 John Wiley & Sons Ltd.

Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline.

PubMed

Chou, Roger; Atlas, Steven J; Stanos, Steven P; Rosenquist, Richard W

2009-05-01

Systematic review. To systematically assess benefits and harms of nonsurgical interventional therapies for low back and radicular pain. Although use of certain interventional therapies is common or increasing, there is also uncertainty or controversy about their efficacy. Electronic database searches on Ovid MEDLINE and the Cochrane databases were conducted through July 2008 to identify randomized controlled trials and systematic reviews of local injections, botulinum toxin injection, prolotherapy, epidural steroid injection, facet joint injection, therapeutic medial branch block, sacroiliac joint injection, intradiscal steroid injection, chemonucleolysis, radiofrequency denervation, intradiscal electrothermal therapy, percutaneous intradiscal radiofrequency thermocoagulation, Coblation nucleoplasty, and spinal cord stimulation. All relevant studies were methodologically assessed by 2 independent reviewers using criteria developed by the Cochrane Back Review Group (for trials) and by Oxman (for systematic reviews). A qualitative synthesis of results was performed using methods adapted from the US Preventive Services Task Force. For sciatica or prolapsed lumbar disc with radiculopathy, we found good evidence that chemonucleolysis is moderately superior to placebo injection but inferior to surgery, and fair evidence that epidural steroid injection is moderately effective for short-term (but not long-term) symptom relief. We found fair evidence that spinal cord stimulation is moderately effective for failed back surgery syndrome with persistent radiculopathy, though device-related complications are common. We found good or fair evidence that prolotherapy, facet joint injection, intradiscal steroid injection, and percutaneous intradiscal radiofrequency thermocoagulation are not effective. Insufficient evidence exists to reliably evaluate other interventional therapies. Few nonsurgical interventional therapies for low back pain have been shown to be effective in randomized, placebo-controlled trials.

Effectiveness of Plaque Control with Novel Pediatric Oral Hygiene Need Station (Modified Oral Irrigation Device) as Compared with Manual Brushing and Flossing: Randomized Controlled Pilot Trial.

PubMed

Murthy, Prashanth Sadashiva; Shaik, Naseemoon; Deshmukh, Seema; Girish, M S

2018-01-01

Establishing good hygiene habits are valuable for present and future oral health. Below 6 years, tooth brushing should be performed by parents, as increasing dexterity and cognition may permit supervised brushing until the child is capable of independent brushing. The aim of the present study was to evaluate the effectiveness of modified oral irrigation device in children in terms of plaque control and to compare the effectiveness of plaque control with manual brushing with the modified oral irrigation device in children. A randomized clinical trial was performed on 12 subjects who were allocated to the two study groups. After obtaining the consent, the control group was instructed tooth brushing with regular pediatric commercially available toothbrush and the intervention group with modified oral irrigation device. Plaque scores in both groups were assessed pre- and post-brushing using modified navy plaque index. The data were subjected to Descriptive statistics and Paired t -test using SPSS version 22. Intragroup comparison of mean difference of plaque score in control group and intervention group pre- and post-brushing was statistically significant. Intergroup comparison of manual brushing group with modified oral irrigation group shows P < 0.05 was statistically significant. Within the limitation of the present study, it has been found novel pediatric oral hygiene need Station is more effective than manual brushing since it combined the effect of brushing, flossing (water floss), and rinsing in children simultaneously and at the same time did not demand any special motor skill.

Validation of self-reported start year of mobile phone use in a Swedish case-control study on radiofrequency fields and acoustic neuroma risk.

PubMed

Pettersson, David; Bottai, Matteo; Mathiesen, Tiit; Prochazka, Michaela; Feychting, Maria

2015-01-01

The possible effect of radiofrequency exposure from mobile phones on tumor risk has been studied since the late 1990s. Yet, empirical information about recall of the start of mobile phone use among adult cases and controls has never been reported. Limited knowledge about recall errors hampers interpretations of the epidemiological evidence. We used network operator data to validate the self-reported start year of mobile phone use in a case-control study of mobile phone use and acoustic neuroma risk. The answers of 96 (29%) cases and 111 (22%) controls could be included in the validation. The larger proportion of cases reflects a more complete and detailed reporting of subscription history. Misclassification was substantial, with large random errors, small systematic errors, and no significant differences between cases and controls. The average difference between self-reported and operator start year was -0.62 (95% confidence interval: -1.42, 0.17) years for cases and -0.71 (-1.50, 0.07) years for controls, standard deviations were 3.92 and 4.17 years, respectively. Agreement between self-reported and operator-recorded data categorized into short, intermediate and long-term use was moderate (kappa statistic: 0.42). Should an association exist, dilution of risk estimates and distortion of exposure-response patterns for time since first mobile phone use could result from the large random errors in self-reported start year. Retrospective collection of operator data likely leads to a selection of "good reporters", with a higher proportion of cases. Thus, differential recall cannot be entirely excluded.

Therapeutic efficacy of self-ligating brackets: A systematic review.

PubMed

Dehbi, Hasnaa; Azaroual, Mohamed Faouzi; Zaoui, Fatima; Halimi, Abdelali; Benyahia, Hicham

2017-09-01

Over the last few years, the use of self-ligating brackets in orthodontics has progressed considerably. These systems have been the subject of numerous studies with good levels of evidence making it possible to evaluate their efficacy and efficiency compared to conventional brackets. The aim of this study was to evaluate the therapeutic efficacy of self-ligating brackets by means of a systematic review of the scientific literature. A systematic study was undertaken in the form of a recent search of the electronic Pubmed database, oriented by the use of several keywords combined by Boolean operators relating to the therapeutic efficacy of self-ligating brackets through the study of tooth alignment, space closure, expansion, treatment duration and degree of discomfort. The search was limited to randomized controlled studies, and two independent readers identified studies corresponding to the selection criteria. The chosen articles comprised 20 randomized controlled trials. The studies analyzed revealed the absence of significant differences between the two types of system on the basis of the clinical criteria adopted, thereby refuting the hypothesis of the superiority of self-ligating brackets over conventional systems. Copyright © 2017 CEO. Published by Elsevier Masson SAS. All rights reserved.

Primary care quality: community health center and health maintenance organization.

PubMed

Shi, Leiyu; Starfield, Barbara; Xu, Jiahong; Politzer, Robert; Regan, Jerrilyn

2003-08-01

This study compares the primary health care quality of community health centers (CHCs) and health maintenance organizations (HMOs) in South Carolina to elucidate the quality of CHC performance relative to mainstream settings such as the HMO. Mail surveys were used to obtain data from 350 randomly selected HMO users. Surveys with follow-up interviews were conducted to obtain data from 540 randomly selected CHC users. A validated adult primary care assessment tool was used in both surveys. Multivariate analyses were performed to assess the association of health care setting (HMO versus CHC) with primary care quality while controlling for sociodemographic and health care characteristics. After controlling for sociodemographic and health care use measures, CHC patients demonstrated higher scores in several primary care domains (ongoing care, coordination of service, comprehensiveness, and community orientation) as well as total primary care performance. Users of CHC are more likely than HMO users to rate their primary health care provider as good, except in the area of ease of first contact. The positive rating of the CHC is particularly impressive after taking into account that many CHC users have characteristics associated with poorer ratings of care.

Dental plaque removal with a novel battery-powered toothbrush.

PubMed

Biesbrock, Aaron R; Walters, Patricia; Bartizek, Robert D; Ruhlman, Douglas; Donly, Kevin J

2002-04-01

To compare the plaque removal efficacy of a positive control power toothbrush (Oral-B Ultra Plaque Remover) to an experimental power toothbrush (Crest SpinBrush) following a single use. This study was a randomized, controlled, examiner-blind, 2-period crossover design which examined plaque removal with the two toothbrushes following a single use in 38 completed subjects. Plaque was scored before and after brushing using the Turesky Modification of the Quigley-Hein Index. Baseline plaque scores were 1.89 and 1.91 for the experimental toothbrush and control toothbrush treatment groups, respectively. With respect to all surfaces examined, the experimental toothbrush delivered an adjusted (via analysis of covariance) mean difference between baseline and post-brushing plaque scores of 0.46 while the control toothbrush delivered an adjusted mean difference of 0.45. These results were not statistically significant (P=0.645). A 95% one-sided upper confidence limit on the Ultra Plaque Remover minus SpinBrush difference in amount of plaque removed was calculated as 9.4% of the Ultra Plaque Remover adjusted mean. A common criterion for what is known as an "at least as good as" test is that the 95% one-sided confidence limit on the product difference is below 10% of the control product mean. Using this criterion, the SpinBrush is at least as good as the Oral-B Ultra Plaque Remover. With respect to buccal and lingual surfaces, the experimental toothbrush delivered very similar results relative to the control toothbrush. These results were also not statistically significant (P> 0.564).

Efficacy of Noninvasive Stellate Ganglion Blockade Performed Using Physical Agent Modalities in Patients with Sympathetic Hyperactivity-Associated Disorders: A Systematic Review and Meta-Analysis.

PubMed

Liao, Chun-De; Tsauo, Jau-Yih; Liou, Tsan-Hon; Chen, Hung-Chou; Rau, Chi-Lun

2016-01-01

Stellate ganglion blockade (SGB) is mainly used to relieve symptoms of neuropathic pain in conditions such as complex regional pain syndrome and has several potential complications. Noninvasive SGB performed using physical agent modalities (PAMs), such as light irradiation and electrical stimulation, can be clinically used as an alternative to conventional invasive SGB. However, its application protocols vary and its clinical efficacy remains controversial. This study investigated the use of noninvasive SGB for managing neuropathic pain or other disorders associated with sympathetic hyperactivity. We performed a comprehensive search of the following online databases: Medline, PubMed, Excerpta Medica Database, Cochrane Library Database, Ovid MEDLINE, Europe PubMed Central, EBSCOhost Research Databases, CINAHL, ProQuest Research Library, Physiotherapy Evidence Database, WorldWideScience, BIOSIS, and Google Scholar. We identified and included quasi-randomized or randomized controlled trials reporting the efficacy of SGB performed using therapeutic ultrasound, transcutaneous electrical nerve stimulation, light irradiation using low-level laser therapy, or xenon light or linearly polarized near-infrared light irradiation near or over the stellate ganglion region in treating complex regional pain syndrome or disorders requiring sympatholytic management. The included articles were subjected to a meta-analysis and risk of bias assessment. Nine randomized and four quasi-randomized controlled trials were included. Eleven trials had good methodological quality with a Physiotherapy Evidence Database (PEDro) score of ≥6, whereas the remaining two trials had a PEDro score of <6. The meta-analysis results revealed that the efficacy of noninvasive SGB on 100-mm visual analog pain score is higher than that of a placebo or active control (weighted mean difference, -21.59 mm; 95% CI, -34.25, -8.94; p = 0.0008). Noninvasive SGB performed using PAMs effectively relieves pain of various etiologies, making it a valuable addition to the contemporary pain management armamentarium. However, this evidence is limited by the potential risk of bias.

Comparing spatial regression to random forests for large environmental data sets

EPA Science Inventory

Environmental data may be “large” due to number of records, number of covariates, or both. Random forests has a reputation for good predictive performance when using many covariates, whereas spatial regression, when using reduced rank methods, has a reputatio...

Disturbance observer based Takagi-Sugeno fuzzy control for an active seat suspension

NASA Astrophysics Data System (ADS)

Ning, Donghong; Sun, Shuaishuai; Zhang, Fei; Du, Haiping; Li, Weihua; Zhang, Bangji

2017-09-01

In this paper, a disturbance observer based Takagi-Sugeno (TS) fuzzy controller is proposed for an active seat suspension; both simulations and experiments have been performed verifying the performance enhancement and stability of the proposed controller. The controller incorporates closed-loop feedback control using the measured acceleration of the seat and deflection of the suspension; these two variables can be easily measured in practical applications, thus allowing the proposed controller to be robust and adaptable. A disturbance observer that can estimate the disturbance caused by friction, model simplification, and controller output error has also been used to compensate a H∞ state feedback controller. The TS fuzzy control method is applied to enhance the controller's performance by considering the variation of driver's weight during operation. The vibration of a heavy duty vehicle seat is largest in the frequency range between 2 Hz and 4 Hz, in the vertical direction; therefore, it is reasonable to focus on controlling low frequency vibration amplitudes and maintain the seat suspensions passivity at high frequency. Moreover, both the simulation and experimental results show that the active seat suspension with the proposed controller can effectively isolate unwanted vibration amplitudes below 4.5 Hz, when compared with a well-tuned passive seat suspension. The active controller has been further validated under bump and random road tests with both a 55 kg and a 70 kg loads. The bump road test demonstrated the controller has good transient response capabilities. The random road test result has been presented both in the time domain and the frequency domain. When with the above two loads, the controlled seat suspensions root-mean-square (RMS) accelerations were reduced by 45.5% and 49.5%, respectively, compared with a well-tuned passive seat suspension. The proposed active seat suspension controller has great potential and is very practical for application as it can significantly improve heavy duty driver's ride comfort.

The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals

PubMed Central

2011-01-01

Background Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. Methods The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and a process evaluation will be performed. Discussion When it is proven effective compared to a control group, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in hospitals to improve employees' mental health and work functioning. Trial Registration NTR2786 PMID:21569282

The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals.

PubMed

Gärtner, Fania R; Ketelaar, Sarah M; Smeets, Odile; Bolier, Linda; Fischer, Eva; van Dijk, Frank J H; Nieuwenhuijsen, Karen; Sluiter, Judith K

2011-05-10

Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and a process evaluation will be performed. When it is proven effective compared to a control group, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in hospitals to improve employees' mental health and work functioning. NTR2786.

Predicting the onset and persistence of episodes of depression in primary health care. The predictD-Spain study: Methodology

PubMed Central

Bellón, Juan Ángel; Moreno-Küstner, Berta; Torres-González, Francisco; Montón-Franco, Carmen; GildeGómez-Barragán, María Josefa; Sánchez-Celaya, Marta; Díaz-Barreiros, Miguel Ángel; Vicens, Catalina; de Dios Luna, Juan; Cervilla, Jorge A; Gutierrez, Blanca; Martínez-Cañavate, María Teresa; Oliván-Blázquez, Bárbara; Vázquez-Medrano, Ana; Sánchez-Artiaga, María Soledad; March, Sebastia; Motrico, Emma; Ruiz-García, Victor Manuel; Brangier-Wainberg, Paulette Renée; del Mar Muñoz-García, María; Nazareth, Irwin; King, Michael

2008-01-01

Background The effects of putative risk factors on the onset and/or persistence of depression remain unclear. We aim to develop comprehensive models to predict the onset and persistence of episodes of depression in primary care. Here we explain the general methodology of the predictD-Spain study and evaluate the reliability of the questionnaires used. Methods This is a prospective cohort study. A systematic random sample of general practice attendees aged 18 to 75 has been recruited in seven Spanish provinces. Depression is being measured with the CIDI at baseline, and at 6, 12, 24 and 36 months. A set of individual, environmental, genetic, professional and organizational risk factors are to be assessed at each follow-up point. In a separate reliability study, a proportional random sample of 401 participants completed the test-retest (251 researcher-administered and 150 self-administered) between October 2005 and February 2006. We have also checked 118,398 items for data entry from a random sample of 480 patients stratified by province. Results All items and questionnaires had good test-retest reliability for both methods of administration, except for the use of recreational drugs over the previous six months. Cronbach's alphas were good and their factorial analyses coherent for the three scales evaluated (social support from family and friends, dissatisfaction with paid work, and dissatisfaction with unpaid work). There were 191 (0.16%) data entry errors. Conclusion The items and questionnaires were reliable and data quality control was excellent. When we eventually obtain our risk index for the onset and persistence of depression, we will be able to determine the individual risk of each patient evaluated in primary health care. PMID:18657275

Promoting Afterschool Quality and Positive Youth Development: Cluster Randomized Trial of the Pax Good Behavior Game.

PubMed

Smith, Emilie Phillips; Osgood, D Wayne; Oh, Yoonkyung; Caldwell, Linda C

2018-02-01

This randomized trial tested a strategy originally developed for school settings, the Pax Good Behavior Game (PAX GBG), in the new context of afterschool programs. We examined this approach in afterschool since 70% of all juvenile crime occurs between the hours of 3-6 pm, making afterschool an important setting for prevention and promotion. Dual-career and working families need monitoring and supervision for their children in quality settings that are safe and appropriately structured. While substantial work has identified important features of afterschool programs, increasing attention is being given to how to foster quality. PAX GBG, with its focus on shared norms, cooperative teams, contingent activity rewards, and liberal praise, could potentially enhance not only appropriate structure and supportive relationships, but also youth self-regulation, co-regulation, and socio-emotional development. This study examined the PAX GBG among 76 afterschool programs, serving 811 youth ages 5-12, who were diverse in race-ethnicity, socio-economic status, and geographic locale. Demographically matched pairs of afterschool programs were randomized to PAX GBG or treatment-as-usual. Independent observers conducted ratings of implementation fidelity and program quality across time; along with surveys of children's problem and prosocial behavior. Interaction effects were found using hierarchical linear models such that experimental programs evidencing higher implementation fidelity demonstrated better program quality than controls, (i.e., less harshness, increased appropriate structure, support, and engagement), as well as reduced child-reported hyperactivity and intent-to-treat effects on prosocial behavior. This study demonstrates that best practices fostered by PAX GBG and implemented with fidelity in afterschool result in higher quality contexts for positive youth development.

Treatment of premenstrual dysphoric disorder (PMDD) with a novel formulation of drospirenone and ethinyl estradiol.

PubMed

De Berardis, Domenico; Serroni, Nicola; Salerno, Rosa Maria; Ferro, Filippo Maria

2007-08-01

Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome (PMS). Pharmacologic options studied for treating severe PMS and PMDD may include selective serotonin reuptake inhibitors, anxiolytic agents, gonadotropin-releasing hormone agonists and the diuretic spironolactone. However, the use of combined oral contraceptives (COC) may be a therapeutic option in treating PMS and PMDD. The combination of drospirenone with ethinylestradiol (EE/drospirenone) was approved for marketing as an oral contraceptive in Europe and the United States. The preparation is characterized by a high contraceptive efficacy in combination with excellent cycle control, good tolerability, and a favourable impact on lipid and glucose metabolism. Recently, some placebo-controlled, randomized studies have tested clinical efficacy and tolerability of this COC in the treatment of PMDD. The aim of the present review was to elucidate the possible benefits or disadvantages of PMDD treatment with this novel formulation of EE/drospirenone. The results of trials evaluating the use of EE/drospirenone combination in the treatment of PMDD are encouraging but further studies are needed. However, the reported clinical efficacy and the relative good tolerability of EE/drospirenone may contribute to widen the therapeutic spectrum of PMDD.

Treatment of premenstrual dysphoric disorder (PMDD) with a novel formulation of drospirenone and ethinyl estradiol

PubMed Central

De Berardis, Domenico; Serroni, Nicola; Salerno, Rosa Maria; Ferro, Filippo Maria

2007-01-01

Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome (PMS). Pharmacologic options studied for treating severe PMS and PMDD may include selective serotonin reuptake inhibitors, anxiolytic agents, gonadotropin-releasing hormone agonists and the diuretic spironolactone. However, the use of combined oral contraceptives (COC) may be a therapeutic option in treating PMS and PMDD. The combination of drospirenone with ethinylestradiol (EE/drospirenone) was approved for marketing as an oral contraceptive in Europe and the United States. The preparation is characterized by a high contraceptive efficacy in combination with excellent cycle control, good tolerability, and a favourable impact on lipid and glucose metabolism. Recently, some placebo-controlled, randomized studies have tested clinical efficacy and tolerability of this COC in the treatment of PMDD. The aim of the present review was to elucidate the possible benefits or disadvantages of PMDD treatment with this novel formulation of EE/drospirenone. The results of trials evaluating the use of EE/drospirenone combination in the treatment of PMDD are encouraging but further studies are needed. However, the reported clinical efficacy and the relative good tolerability of EE/drospirenone may contribute to widen the therapeutic spectrum of PMDD. PMID:18472980

Turning lemonade into lemons: Dampening appraisals reduce positive affect and increase negative affect during positive activity scheduling.

PubMed

Burr, Leigh-Anne; Javiad, Mahmood; Jell, Grace; Werner-Seidler, Aliza; Dunn, Barnaby D

2017-04-01

The way individuals appraise positive emotions may modulate affective experience during positive activity scheduling. Individuals may either engage in dampening appraisals (e.g., think "this is too good to last") or amplifying appraisals (e.g., think "I deserve this"). A cross-over randomized design was used to examine the consequences of these appraisal styles. Participants (N = 43) rated positive affect (PA) and negative affect (NA) during four daily walks in pleasant locations, whilst following dampening, emotion-focus amplifying (focusing on how good one feels), self-focus amplifying (focusing on positive self qualities), or control instructions. There was no difference between the two amplifying and control conditions, which all increased PA and reduced NA during the walks. However, the dampening condition significantly differed from all other conditions, reducing PA and increasing NA during the walk. Individual differences in anhedonia symptoms did not significantly moderate the pattern of findings. This evidence supports the view that dampening appraisals may be one mechanism driving anhedonia and may account for why positive activity scheduling can sometimes backfire when utilized in the clinic. Copyright © 2017 Elsevier Ltd. All rights reserved.

Innovative hyperchaotic encryption algorithm for compressed video

NASA Astrophysics Data System (ADS)

Yuan, Chun; Zhong, Yuzhuo; Yang, Shiqiang

2002-12-01

It is accepted that stream cryptosystem can achieve good real-time performance and flexibility which implements encryption by selecting few parts of the block data and header information of the compressed video stream. Chaotic random number generator, for example Logistics Map, is a comparatively promising substitute, but it is easily attacked by nonlinear dynamic forecasting and geometric information extracting. In this paper, we present a hyperchaotic cryptography scheme to encrypt the compressed video, which integrates Logistics Map with Z(232 - 1) field linear congruential algorithm to strengthen the security of the mono-chaotic cryptography, meanwhile, the real-time performance and flexibility of the chaotic sequence cryptography are maintained. It also integrates with the dissymmetrical public-key cryptography and implements encryption and identity authentification on control parameters at initialization phase. In accord with the importance of data in compressed video stream, encryption is performed in layered scheme. In the innovative hyperchaotic cryptography, the value and the updating frequency of control parameters can be changed online to satisfy the requirement of the network quality, processor capability and security requirement. The innovative hyperchaotic cryprography proves robust security by cryptoanalysis, shows good real-time performance and flexible implement capability through the arithmetic evaluating and test.

Meta-analyses evaluating surrogate endpoints for overall survival in cancer randomized trials: A critical review.

PubMed

Savina, Marion; Gourgou, Sophie; Italiano, Antoine; Dinart, Derek; Rondeau, Virginie; Penel, Nicolas; Mathoulin-Pelissier, Simone; Bellera, Carine

2018-03-01

In cancer randomized controlled trials (RCT), alternative endpoints are increasingly being used in place of overall survival (OS) to reduce sample size, duration and cost of trials. It is necessary to ensure that these endpoints are valid surrogates for OS. Our aim was to identify meta-analyses that evaluated surrogate endpoints for OS and assess the strength of evidence for each meta-analysis (MA). We performed a systematic review to identify MA of cancer RCTs assessing surrogate endpoints for OS. We evaluated the strength of the association between the endpoints based on (i) the German Institute of Quality and Efficiency in Health Care guidelines and (ii) the Biomarker-Surrogate Evaluation Schema. Fifty-three publications reported on 164 MA, with heterogeneous statistical methods Disease-free survival (DFS) and progression-free survival (PFS) showed good surrogacy properties for OS in colorectal, lung and head and neck cancers. DFS was highly correlated to OS in gastric cancer. The statistical methodology used to evaluate surrogate endpoints requires consistency in order to facilitate the accurate interpretation of the results. Despite the limited number of clinical settings with validated surrogate endpoints for OS, there is evidence of good surrogacy for DFS and PFS in tumor types that account for a large proportion of cancer cases. Copyright © 2017 Elsevier B.V. All rights reserved.

Comparison effect of physiotherapy with surgery on sexual function in patients with pelvic floor disorder: A randomized clinical trial.

PubMed

Eftekhar, Tahereh; Sohrabi, Maryam; Haghollahi, Fedyeh; Shariat, Mamak; Miri, Elahe

2014-01-01

Female sexual dysfunction is a common problem among general population, especially in urogynecological patient, and can lead to a decrease in quality of life and affect martial relationship. This study was compared the effect of surgical methods versus physiotherapy on sexual function in pelvic floor disorder. This randomized controlled trial was performed in Urogynecology clinic since August 2007 to December 2009 on 90 patients aged from 25-55 years with previous delivery, positive history of sexual dysfunction with stage <3 of pelvic organ prolapsed and divided in two groups. Group A (n=45) received standard rectocele repair and prineorrhaphy, group B (n=45) received physiotherapy for eight weeks twice a week (electrical stimulation, Kegel exercises). The female sexual function index (FSFI) used to evaluate the sexual function in cases before and after intervention. Frequency of variable scores (libido, orgasm, dysparunia) included without disorder, frequently good, sometimes good, very much and extreme were compared between two groups. Libido and arousal were improved in both groups (p=0.007, p=0.001 respectively). Orgasm and dyspareunia were improved in group B (p=0.001). Dysparunia was more painful in group A. There was significant difference between two groups (improvement of orgasm and dysparunia in group B) (p=0.001). It seems that physiotherapy is an appropriate method for treatment of sexual disorder in pelvic floor disorder. IRCT2013031112790N1.

Randomized assessment of rapid endovascular treatment of ischemic stroke.

PubMed

Goyal, Mayank; Demchuk, Andrew M; Menon, Bijoy K; Eesa, Muneer; Rempel, Jeremy L; Thornton, John; Roy, Daniel; Jovin, Tudor G; Willinsky, Robert A; Sapkota, Biggya L; Dowlatshahi, Dar; Frei, Donald F; Kamal, Noreen R; Montanera, Walter J; Poppe, Alexandre Y; Ryckborst, Karla J; Silver, Frank L; Shuaib, Ashfaq; Tampieri, Donatella; Williams, David; Bang, Oh Young; Baxter, Blaise W; Burns, Paul A; Choe, Hana; Heo, Ji-Hoe; Holmstedt, Christine A; Jankowitz, Brian; Kelly, Michael; Linares, Guillermo; Mandzia, Jennifer L; Shankar, Jai; Sohn, Sung-Il; Swartz, Richard H; Barber, Philip A; Coutts, Shelagh B; Smith, Eric E; Morrish, William F; Weill, Alain; Subramaniam, Suresh; Mitha, Alim P; Wong, John H; Lowerison, Mark W; Sajobi, Tolulope T; Hill, Michael D

2015-03-12

Among patients with a proximal vessel occlusion in the anterior circulation, 60 to 80% of patients die within 90 days after stroke onset or do not regain functional independence despite alteplase treatment. We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core, a proximal intracranial arterial occlusion, and moderate-to-good collateral circulation. We randomly assigned participants to receive standard care (control group) or standard care plus endovascular treatment with the use of available thrombectomy devices (intervention group). Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset. Patients with a large infarct core or poor collateral circulation on computed tomography (CT) and CT angiography were excluded. Workflow times were measured against predetermined targets. The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care (shift analysis). The trial was stopped early because of efficacy. At 22 centers worldwide, 316 participants were enrolled, of whom 238 received intravenous alteplase (120 in the intervention group and 118 in the control group). In the intervention group, the median time from study CT of the head to first reperfusion was 84 minutes. The rate of functional independence (90-day modified Rankin score of 0 to 2) was increased with the intervention (53.0%, vs. 29.3% in the control group; P<0.001). The primary outcome favored the intervention (common odds ratio, 2.6; 95% confidence interval, 1.7 to 3.8; P<0.001), and the intervention was associated with reduced mortality (10.4%, vs. 19.0% in the control group; P=0.04). Symptomatic intracerebral hemorrhage occurred in 3.6% of participants in intervention group and 2.7% of participants in control group (P=0.75). Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderate-to-good collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality. (Funded by Covidien and others; ESCAPE ClinicalTrials.gov number, NCT01778335.).

Comparing twice- versus four-times daily insulin in mothers with gestational diabetes in Pakistan and its implications.

PubMed

Saleem, Nazish; Godman, Brian; Hussain, Shahzad

2016-08-01

Gestational diabetes mellitus is a common medical problem associated with maternal and fetal complications. Good glycemic control is the cornerstone of treatment. Compare outcomes between four times (q.i.d) and twice daily (b.i.d) regimens. The morning dose of the b.i.d regimen contained two-thirds of the total insulin, comprising a third human regular insulin and two-thirds human intermediate insulin; equal amounts in the evening. 480 women at >30 weeks with gestational diabetes mellitus with failure to control blood glucose were randomly assigned to either regimen. Mean time to the control of blood glucose was significantly less and glycemic control significantly increased with the q.i.d regimen. Operative deliveries, extent of neonatal hypoglycemia, babies with low Agpar scores and those with hyperbilirubinemia were significantly higher with the b.i.d daily regimen. The q.i.d daily regime was associated with improved fetal and maternal outcomes. Consequently should increasingly be used in Pakistan, assisted by lower acquisition costs.

Protocol for digital intervention for effective health promotion of small children-A cluster randomized trial.

PubMed

Pakarinen, Anni; Flemmich, Magda; Parisod, Heidi; Selänne, Laura; Hamari, Lotta; Aromaa, Minna; Leppänen, Ville; Löyttyniemi, Eliisa; Smed, Jouni; Salanterä, Sanna

2018-03-08

This article introduces the protocol of a study aiming to evaluate the effectiveness of digital WellWe intervention in supporting the participation of families with small children in the promotion of their health. Early childhood is a meaningful period for building a strong base for good health. Parents play a key role in affecting the health behaviour and psychosocial development of their children. A family-centred approach makes it possible to support families' individual health literacy needs and empower them to take actions towards promoting healthier behaviour. However, there are a lack of family-centred digital health interventions intended for parents and their small children. The study is designed as a two-arm cluster, randomized, controlled trial with a 4-month follow-up. The data are being collected from 200 families with a 4-year-old child. Cluster randomization is being performed at the municipality level. Municipalities (N = 4) located in Southwest Finland, comprising child health clinics (N = 15) with their family clients, were randomly allocated to either an intervention (WellWe intervention) or a control group (usual care). The outcome measures include parental self-efficacy for healthy behaviours, mindfulness in parenting and the family-centred approach of the extensive health examination. Data collection is being performed at baseline, after the intervention and at a 4-month follow-up. The results from this study will make it possible to determine whether this new method can be recommended for implementation in child health clinic settings to support the participation of families with small children in promoting their health. © 2018 John Wiley & Sons Ltd.

Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study.

PubMed

Shah, Gaurang R; Chaudhari, Manojkumar V; Patankar, Suresh B; Pensalwar, Shrikant V; Sabale, Vilas P; Sonawane, Navneet A

2012-09-15

Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) - a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study. 78 men aged 25-50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator's Global assessment and Subjects' opinion. In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P < 0.0001). Similar results were observed in each of the remaining four domains of the IIEF (orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P < 0.001. Thirty-five out of 39 (90%) subjects from the VXP group and one (3%) from the placebo group wished to continue with the treatment they received. Investigator's global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject's rating for tolerability of treatment was similar in both groups. VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men. Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009.

Genomic relations among 31 species of Mammillaria haworth (Cactaceae) using random amplified polymorphic DNA.

PubMed

Mattagajasingh, Ilwola; Mukherjee, Arup Kumar; Das, Premananda

2006-01-01

Thirty-one species of Mammillaria were selected to study the molecular phylogeny using random amplified polymorphic DNA (RAPD) markers. High amount of mucilage (gelling polysaccharides) present in Mammillaria was a major obstacle in isolating good quality genomic DNA. The CTAB (cetyl trimethyl ammonium bromide) method was modified to obtain good quality genomic DNA. Twenty-two random decamer primers resulted in 621 bands, all of which were polymorphic. The similarity matrix value varied from 0.109 to 0.622 indicating wide variability among the studied species. The dendrogram obtained from the unweighted pair group method using arithmetic averages (UPGMA) analysis revealed that some of the species did not follow the conventional classification. The present work shows the usefulness of RAPD markers for genetic characterization to establish phylogenetic relations among Mammillaria species.

A randomized, controlled trial of a multifaceted intervention including alcohol-based hand sanitizer and hand-hygiene education to reduce illness transmission in the home.

PubMed

Sandora, Thomas J; Taveras, Elsie M; Shih, Mei-Chiung; Resnick, Elissa A; Lee, Grace M; Ross-Degnan, Dennis; Goldmann, Donald A

2005-09-01

Good hand hygiene may reduce the spread of infections in families with children who are in out-of-home child care. Alcohol-based hand sanitizers rapidly kill viruses that are commonly associated with respiratory and gastrointestinal (GI) infections. The objective of this study was to determine whether a multifactorial campaign centered on increasing alcohol-based hand sanitizer use and hand-hygiene education reduces illness transmission in the home. A cluster randomized, controlled trial was conducted of homes of 292 families with children who were enrolled in out-of-home child care in 26 child care centers. Eligible families had > or =1 child who was 6 months to 5 years of age and in child care for > or =10 hours/week. Intervention families received a supply of hand sanitizer and biweekly hand-hygiene educational materials for 5 months; control families received only materials promoting good nutrition. Primary caregivers were phoned biweekly and reported respiratory and GI illnesses in family members. Respiratory and GI-illness-transmission rates (measured as secondary illnesses per susceptible person-month) were compared between groups, adjusting for demographic variables, hand-hygiene practices, and previous experience using hand sanitizers. Baseline demographics were similar in the 2 groups. A total of 1802 respiratory illnesses occurred during the study; 443 (25%) were secondary illnesses. A total of 252 GI illnesses occurred during the study; 28 (11%) were secondary illnesses. The secondary GI-illness rate was significantly lower in intervention families compared with control families (incidence rate ratio [IRR]: 0.41; 95% confidence interval [CI]: 0.19-0.90). The overall rate of secondary respiratory illness was not significantly different between groups (IRR: 0.97; 95% CI: 0.72-1.30). However, families with higher sanitizer usage had a marginally lower secondary respiratory illness rate than those with less usage (IRR: 0.81; 95% CI: 0.65-1.09). A multifactorial intervention emphasizing alcohol-based hand sanitizer use in the home reduced transmission of GI illnesses within families with children in child care. Hand sanitizers and multifaceted educational messages may have a role in improving hand-hygiene practices within the home setting.

A randomized, controlled trial of oral sulfate solution plus polyethylene glycol as a bowel preparation for colonoscopy.

PubMed

Rex, Douglas K; McGowan, John; Cleveland, Mark vB; Di Palma, Jack A

2014-09-01

No bowel preparation for colonoscopy is optimal with regard to efficacy, safety, and tolerability. New options for bowel preparation are needed. To compare a new hybrid preparation consisting of a reduced dose of oral sulfate solution (OSS) plus 2 L of sulfate-free electrolyte lavage solution (SF-ELS) with 2 low-volume preparations based on polyethylene glycol electrolyte lavage solution (PEG-ELS). Two randomized, controlled trials. Twenty-four U.S. centers. A total of 737 outpatients undergoing colonoscopy. In study 1, OSS plus SF-ELS was given as a split dose, and in study 2, OSS plus SF-ELS was given in its entirety the evening before colonoscopy. In study 1, the active control was 2 L of PEG-ELS plus ascorbic acid (PEG-EA) given as a split dose. In study 2, the control was 10 mg of bisacodyl plus 2 L of SF-ELS taken the evening before colonoscopy. Rates of successful (good or excellent) bowel preparation. In study 1, the rates of successful (excellent or good) preparation with OSS plus SF-ELS and PEG-EA were identical at 93.5% for split-dose preparation. OSS plus SF-ELS was noninferior to PEG-EA (P < .001). In study 2, OSS plus SF-ELS resulted in successful preparation in 89.8% of patients compared with 83.5% with bisacodyl plus SF-ELS in a same-day preparation regimen. OSS plus SF-ELS was noninferior to bisacodyl plus SF-ELS (P <.001). In study 1, vomiting was more frequent with OSS plus SF-ELS (13.5% vs 6.7%; P = .042), and bloating was rated worse with PEG-EA (P = .025). In study 2, overall discomfort was rated worse with OSS plus SF-ELS (mean score 2.1 vs 1.8; P = .032). There were no deaths in either study and no serious adverse events considered related to the preparation. Bowel cleansing was not scored by colon segment. Adenoma detection was not compared between the regimens. OSS plus SF-ELS is a new, safe, and effective bowel preparation for colonoscopy. Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

[Justification of off-label antibiotics uses in hospitalized children].

PubMed

Berthod, Christelle; Kassaï, Behrouz; Boussageon, Remy; Adelaide, Léopold; Jacquet-Lagrèze, Matthias; Lajoinie, Audrey

2017-12-01

Unlicensed and off-label (UL/OL) drugs are commonly used in pediatrics wards, especially the antibiotics. It remains unclear if this strategy is justified by randomized controlled trials of good quality? The aim of this study was to compare the level of evidence of UL/OL antibiotics prescription in hospitalized children. The initial hypothesis was that the UL/OL antibiotics prescriptions had a lower level of evidence than licensed antibiotics. This observational study assessed the antibiotics prescription in the children mother and women hospital of Lyon. Each antibiotic medicine courses was classified depending on: (i) they were licensed, UL or OL, (ii) their level of evidence for efficiency (sufficient evidence, insufficient evidence, no evidence) and (iii) the existence or not of randomized controlled trials (RCT) or not. The antibiotics medicine courses in atypical cases were excluded (rare disease, lack of diagnosis, comorbidities modifying antibiotic use). Data were collected with computerized patient file data. The data were compared using Fisher exact test and χ 2 . One hundred and eight medicine courses were identified, corresponding to 72 mono, bi or tri-antibiotic therapies administered to 62 patients; 34% were OL and 66% were licensed. No prescriptions were UL. Thirty-two prescriptions were excluded from the evidence assessment. No proof of efficiency was found for any of the 76 analyzed medicine courses. RCTs were found for 36 of the analyzed medicine courses (47%); licensed medicine courses were significantly more justified by RCTs than UL/OL medicine courses (63% vs. 16%, P<0.001). This study has shown the absence of RCTs of good quality to justify the prescriptions of antibiotics in pediatrics, regardless their license status. Nevertheless, the licensed prescriptions have shown more data of efficiency than OL prescriptions. Still, even when data were found, no antibiotics prescriptions reach the threshold of good quality studies. New clinical trials should respond to the patient needs. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Comparing the Effects of Zinc Sulfate, Calcium Pantothenate, Their Combination and Minoxidil Solution Regimens on Controlling Hair Loss in Women: A Randomized Controlled Trial.

PubMed

Siavash, Mansour; Tavakoli, Fereshteh; Mokhtari, Fatemeh

2017-01-01

This study was conducted to evaluate the combination of oral supplements with 2% minoxidil solution in four groups of women with hair loss. A prospective, randomized controlled trial was conducted from July to December 2016 in dermatology clinics affiliated to Isfahan University of Medical Sciences. A total of 73, 15-45-year-old, women with hair loss participated in this 4-month study. Simple randomization using Random Allocation Software was done to put the participants in four groups to receive coadministration of zinc sulfate and calcium pantothenate, zinc sulfate, calcium pantothenate, and 2% minoxidil solution. The primary endpoint was the change in hair density and diameter measured by dermatoscope. Secondary endpoints included the researcher's evaluation, dermatologist's opinion - which was blinded to the study - from comparing the participants' photographs before and after treatment and finally, overall changes in hair density measured by participants' self-assessment. Seventy-three women participated in this study. Primary hair count and thickness were 118.5 ± 10 hairs/cm 2 and 58.8 ± 5.8 μ that changed to 124 ± 11 hairs/cm 2 and 62.3 ± 4.3 μ respectively ( P < 0.001) which in the zinc plus pantothenate group these changes were from 118.6 ± 9.9 hairs/cm 2 to 121.9 ± 11.1 hairs/cm 2 ( P = 0.042) and from 62.2 ± 6.6 μ to 64.0 ± 5.0 μ ( P = 0.126), respectively. Hair density increments were more obvious in the minoxidil group, and hair thickness increments were more obvious in pantothenate group. Participants' satisfaction was 85% in the combination therapy which was more than other groups. Participants' satisfaction, author's and blind dermatologist's opinion showed a significant correlation ( P = 0.0001). Based on the participants' satisfaction, the combination of zinc sulfate and calcium pantothenate when administered in a pulse therapy way could be a good choice for hair loss controlling in initial stages.

Who Recommends Long-Term Care Matters

ERIC Educational Resources Information Center

Kane, Robert L.; Bershadsky, Boris; Bershadsky, Julie

2006-01-01

Purpose: Making good consumer decisions requires having good information. This study compared long-term-care recommendations among various types of health professionals. Design and Methods: We gave randomly varied scenarios to a convenience national sample of 211 professionals from varying disciplines and work locations. For each scenario, we…

Tetracycline treatment of type III prostatitis nanobacteria infection of 100 cases report

NASA Astrophysics Data System (ADS)

Guo, Junyi; Li, Chongxian; Wu, Baisuo; Hao, Shaojun; Ming, Aimin; Zhang, Xinji; Li, Wenjun; Zhang, Zhengchen

2018-04-01

To investigate the efficacy of tetracycline treatment of nanobacterial infection in 100 cases of type III prostatitis. randomly divided into treatment group and control group with double blind method, the treatment group was given Tetracycline Tablets 250mg, oral, 2 times a day; the control group were treated with Levofloxacin Tablets 0.lg, oral, 2 times a day; observation of curative effect of two groups of patients after 1 months of treatment. after the treatment group patients NIH-CPSI score and pain, urinary symptoms and quality of life scores were significantly lower than that of control group (P<0.01); after treatment, observation group lecithin corpuscle scale score was significantly higher than the control group (P<0.05). The treatment group and the control group patients after prostate fluid and cultured positive cases of nanobacterial numbers were 21 (21%) and 100 cases (100%), the positive rate of nanobacteria in observation group was significantly lower than the control group (P<0.05). There is a good effect Tetracycline Tablets treatment of nanobacterial infection of type III prostatitis.

[Effects of Ginkgo biloba extract in improving episodic memory of patients with mild cognitive impairment: a randomized controlled trial].

PubMed

Zhao, Ming-xing; Dong, Zhen-hua; Yu, Zhong-hai; Xiao, Shi-yuan; Li, Ya-ming

2012-06-01

Mild cognitive impairment is a transitional stage between normal aging and dementia. It is important in terms of recognizing memory loss in older people as well as identifying a group of individuals at high risk of developing dementia and who may benefit from preventive strategies. Ginkgo biloba extract has been shown to possess polyvalent properties, such as anti-oxidation, anti-apoptosis and anti-inflammation. Ginkgo biloba extract appears to have a neuroprotective effect against neurodegenerative diseases. To observe the efficacy of Ginkgo biloba leaf tablet in improving episodic memory of mild cognitive impairment. This is a multicenter, randomized, controlled trial. The authors enrolled generally healthy, ambulatory or ambulatory-aided amnestic subjects with MCI, 60 to 85 years old, who expressed a memory complaint from Huadong Hospital, seven Community Health Centers in Shanghai, and Shanghai First Welfare Institution. A total of 120 MCI patients were randomly assigned to the Ginkgo biloba leaf tablet group (treatment group, 60 cases) and control group (60 cases). The patients in the treatment group took Ginkgo biloba leaf tablets 3 times a day, 19.2 mg each dose. The control group did not receive any intelligence-promoting or vasodilator reflex treatment except some health care. The patients were tested with nonsense picture recognition of the clinical memory scale and the logical memory test based on the Wechsler memory scale before and after treatment. After 6 months of treatment, the scores of the logical memory test and nonsense picture recognition were increased significantly in the treatment group (P<0.01, P<0.05), while the scores of the two tests from the control group had no statistically significant difference (P>0.05). After treatment, the positive rate of nonsense picture recognition was 55.17% in the treatment group, which was significantly higher than that of the control group at 32.73% (P<0.05). The efficacy rate of logical memory was 58.62% in the treatment group, also higher than 38.18% in the control group (P<0.05). Ginkgo biloba leaf tablet showed good efficacy in promoting episodic memory function in MCI patients.

Randomized and controlled clinical study of modified prescriptions of Simiao Pill in the treatment of acute gouty arthritis.

PubMed

Shi, Xin-de; Li, Guo-chun; Qian, Zu-xi; Jin, Ze-qiu; Song, Yan

2008-03-01

To investigate the compatibility of a modified prescription of Simiao Pill in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial. A randomized and controlled clinical trial was designed based on clinical epidemiological principles. A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group I) included 27 patients taking gout prescription I; the second group (Group II) included 27 patients taking gout prescription II; the third group (Group III) included 28 patients taking gout prescription III; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment, the index of blood uric acid, blood leukocyte count, score of clinical symptoms, etc. were observed and measured. The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%, significantly superior to that of the control group (68%, P<0.05). In terms of the improvement of main symptoms, the scores of four symptoms in all TCM treatment and control groups decreased after treatment, with statistically significant differences (P<0.05). Moreover, the scores markedly fell more so in the three Chinese herb groups than in the control group, and especially in Group III (P<0.05). There was a statistically significant difference in blood uric acid values before and after the treatment in the same group but no significant inter-group difference was seen. The modified prescriptions, based on the clinical research, clinical experience and traditional Chinese medicine theory, did show a better effect than Western medicine in this clinical study. Moreover, the prescriptions were precise, with the herbs inexpensive and readily available. The patients had good compliance with less adverse reactions noted. The modified prescription has a favorable prospect for future development and is worthy of further blind trials with larger samples.

A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

PubMed Central

Kim, Jinyoung; Cho, Jae-Heung

2017-01-01

This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication, Gongjindan (GJD), in patients with chronic dizziness. This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, clinical trial. Seventy-eight patients diagnosed with Meniere's disease, psychogenic dizziness, or dizziness of unknown cause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g GJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale) and frequency of dizziness, balance function (Berg Balance Scale), fatigue (Fatigue Severity Scale) and deficiency pattern/syndrome (qi blood yin yang-deficiency questionnaire) levels, and depression (Korean version of Beck's Depression Inventory) and anxiety (State-Trait Anxiety Inventory) levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the incremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions' questionnaire) and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two-sided). This trial is registered with ClinicalTrials.gov NCT03219515, in July 2017. PMID:29387128

A randomized 3-month clinical comparison of a power toothbrush to a manual toothbrush in the reduction of gingivitis.

PubMed

Li, Zhen; He, Tao; Li, Chun; Sun, Lily; Chang, Jinlan; He, Yanyan; Zhao, Jizhi; Ji, Ning

2016-08-01

To compare the anti-gingivitis effect of a power toothbrush relative to a manual toothbrush control. This was a 3-month, randomized and controlled, single-center, parallel group, examiner-blinded clinical study. 123 Chinese adults in good general health and with at least 15 gingival bleeding sites, as measured by the Gingival Bleeding Index, were enrolled into the study. At baseline, pre-treatment gingivitis levels were assessed using the Mazza Bleeding Index. Subjects were then randomly assigned to receive either an oscillating-rotating power toothbrush [Oral-B Professional Care 7000 (D17u/EB17)] or a flat-trim manual toothbrush with tapered filaments (Lion Dentor Systema). Subjects brushed at home twice-daily with their assigned toothbrush and a marketed sodium fluoride dentifrice (Crest Cavity Protection dentifrice), and were reevaluated at Months 1, 2, and 3. 113 evaluable subjects completed the study. Both groups showed significant reductions in gingivitis from baseline for all time points measured (P< 0.001). At Months 1, 2 and 3, the power toothbrush demonstrated significantly greater gingivitis reductions of 7.11%, 9.20% and 8.47%, respectively, than the manual toothbrush (P< 0.01), and significantly fewer bleeding sites (17.3%, 23.9% and 24.3%, respectively, P< 0.05). No adverse events were reported or observed for either brush during the study. The power brush provided statistically significantly greater reductions in gingivitis compared with a manual toothbrush at Months 1, 2 and 3.

A booster dose of an inactivated enterovirus 71 vaccine in chinese young children: a randomized, double-blind, placebo-controlled clinical trial.

PubMed

Shenyu, Wang; Jingxin, Li; Zhenglun, Liang; Xiuling, Li; Qunying, Mao; Fanyue, Meng; Hua, Wang; Yuntao, Zhang; Fan, Gao; Qinghua, Chen; Yuemei, Hu; Xin, Yao; Huijie, Guo; Fengcai, Zhu

2014-10-01

A significant waning of enterovirus 71 (EV71) antibody titer after priming immunization with an inactivated EV71 vaccine implied the potential need for a booster dose. In this randomized, double-blind, placebo-controlled clinical trial, we recruited participants who had received at least 1 dose of priming EV71 vaccine in an early phase 2 clinical trial that was conducted in healthy infants and children aged 6-35 months. All participants were grouped according to the priming EV71 vaccine formulations (160 U, 320 U, and 640 U with adjuvant and 640 U without adjuvant) and then randomly assigned (ratio, 2:1) to receive a booster dose of vaccine or placebo within each formulation group. The primary end point was the geometric mean titer 28 days after the booster dose. A total of 773 participants were enrolled. Significantly greater immunological responses were induced by the booster shot of all 4 formulations of EV71 vaccine, compared with that induced by placebo (P < .0001). The frequencies of adverse reactions were similar between vaccine and placebo groups within each formulation group. A booster dose of EV71 vaccine 1 year after the priming EV71 immunization shows excellent immunogenicity and good safety profile. Clinical Trials Registration: NCT01734408. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

How best to assess suppression in patients with high anisometropia.

PubMed

Li, Jinrong; Hess, Robert F; Chan, Lily Y L; Deng, Daming; Chen, Xiang; Yu, Minbin; Thompson, Benjamin S

2013-02-01

We have recently described a rapid technique for measuring suppression using a dichoptic signal/noise task. Here, we report a modification of this technique that allows for accurate measurements to be made in amblyopic patients with high levels of anisometropia. This was necessary because aniseikonic image size differences between the two eyes can provide a cue for signal/noise segregation and, therefore, influence suppression measurement in these patients. Suppression was measured using our original technique and with a modified technique whereby the size of the signal and noise elements was randomized across the stimulus to eliminate size differences as a cue for task performance. Eleven patients with anisometropic amblyopia, five with more than 5 diopters (D) spherical equivalent difference (SED), six with less than 5 D SED between the eyes, and 10 control observers completed suppression measurements using both techniques. Suppression measurements in controls and patients with less than 5 D SED were constant across the two techniques; however, patients with more than 5 D SED showed significantly stronger suppression on the modified technique with randomized element size. Measurements made with the modified technique correlated with the loss of visual acuity in the amblyopic eye and were in good agreement with previous reports using detailed psychophysical measurements. The signal/noise technique for measuring suppression can be applied to patients with high levels of anisometropia and aniseikonia if element size is randomized. In addition, deeper suppression is associated with a greater loss of visual acuity in patients with anisometropic amblyopia.

Teleconsultation in type 1 diabetes mellitus (TELEDIABE).

PubMed

Bertuzzi, Federico; Stefani, Ilario; Rivolta, Benedetta; Pintaudi, Basilio; Meneghini, Elena; Luzi, Livio; Mazzone, Antonino

2018-02-01

The growing incidence of diabetes and the need to contain healthcare costs empower the necessity to identify new models of care. Telemedicine offers an acknowledged instrument to provide clinical health care at a distance, increasing patient compliance and the achievement of therapeutical goals. The objective was to test the feasibility and the efficacy in the improvement of the glycemic control of the teleconsultation for patients with type 1 diabetes mellitus. A randomized open-label, parallel arms, controlled trial was conducted in two diabetes centers in Italy. Participants affected by type 1 diabetes mellitus have been randomly (1:1) assigned to receive their visits as standard or a web-based care. Patients in the teleconsultation group can arrange their appointments on a Web site and can also have access to web educational courses or to nutritional and psychological counseling. The primary outcome was the assessment of glycemic control by HbA1c measurement after a 12-month follow-up. Overall 74 participants were followed for 1 year. HbA1c changes were not statistically different within (p = 0.56 for standard care group; p = 0.45 for telemedicine group) and between (p = 0.60) groups when considering differences from baseline to the end of the study. Patients randomized to teleconsultation reported reduced severe hypoglycemic episodes (p = 0.03). In addition, they were largely satisfied with the activities, perceived a good improvement in the self-management of the diabetes, and reported to have a time saving and a cost reduction. In conclusion, TELEDIABE proposes a new system for the management of patients with type 1 diabetes mellitus.

Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study.

PubMed

Leng, Xiaomei; Li, Zhanguo; Lv, Houshan; Zheng, Yi; Liu, Yi; Dai, Kerong; Yao, Chen; Yan, Xiaoyan; Zeng, Xiaofeng

2015-07-01

The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to severe musculoskeletal pain inadequately controlled with nonsteroidal anti-inflammatory drugs, compared with sustained-release tramadol tablets. Eligible patients were randomized (1:1) to receive low-dose 7-day BTDS (5, 10, and 20 μg/h, maximum dosage of 20 μg/h) or sustained-release tramadol tablets (100 mg, maximum dosage of 400 mg/d) over an 8-week double-blind treatment period (3-week titration, 5-week maintenance). The primary endpoint was the difference in the visual analogue scale (VAS) pain scores from baseline to treatment completion. Noninferiority was assumed if the treatment difference on the VAS scale was within ±1.5 cm, this threshold indicating a clinically meaningful result. ClinicalTrials.gov identifier: NCT01476774. Two hundred eighty patients were randomized to BTDS (n=141) or to tramadol (n=139). Both treatments were associated with a significant reduction in pain by the end of the treatment. The least squares mean difference of the change from baseline in VAS scores between the BTDS and tramadol groups were 0.45 (95% confidence interval, -0.02 to 0.91), which was within the ±1.5 cm predefined threshold, indicating that the effectiveness of BTDS was not inferior to the effectiveness of sustained-release tramadol tablets. The incidence of adverse events was comparable between the 2 treatment groups. Our results suggest that BTDS is a good therapeutic option for patients experiencing chronic musculoskeletal pain of moderate to severe intensity that is insufficiently controlled by nonsteroidal anti-inflammatory drugs.

Efficacy of a new sealant to prevent white spot lesions during fixed orthodontic treatment : A 12-month, single-center, randomized controlled clinical trial.

PubMed

Hammad, Shaza M; Knösel, Michael

2016-11-01

White spot lesions (WSLs) are an undesirable side effect of fixed orthodontic appliance therapy and are reported to occur in 2-96 % of orthodontic patients. In this study, the efficacy of a new sealant to prevent WSLs during fixed orthodontic treatment was compared to a control group that did not receive sealant. For this 2-arm parallel-group randomized trial, 50 subjects aged 12-18 years (mean age 14.57 ± 2.04 years) were recruited from the orthodontics department at Mansoura University, Egypt. Eligibility criteria were no restorations, no active WSLs or caries, and adequate oral hygiene. Subjects were randomized in a 1:1 ratio to one of the two arms prior to undergoing fixed orthodontic treatment, namely a single application of SeLECT Defense™ sealant during the bracketing appointment or no sealant (control arm). Instructions and dentifrices for local home fluoridation regimen were identical in both groups. Oral hygiene was assessed using the Approximal Plaque Index (API) at specified time intervals. Dental photographs were taken for blinded WSLs assessment; inter- and intra-operator error were also calculated. Categorical data were tested using the χ 2 test, and a logistic regression model was adopted to detect associations between decalcification (WSLs), sealant application, and oral hygiene status. Only excellent or good oral hygiene were independent prognostic factors for preventing severe WSLs (p = 0.035). No significant effect on caries incidence was observed for the sealant. In combination with adequate oral hygiene SeLECT Defense™ helps to reduced the frequency of WSLs. However, the sealat showed no significant effect as sole preventive strategy.

Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial.

PubMed

Boussi-Gross, Rahav; Golan, Haim; Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

2013-01-01

Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. "Mindstreams" was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. ClinicalTrials.gov NCT00715052.

Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial.

PubMed

Taverner, Murray; Loughnan, Terence

2014-02-01

Shoulder pain is the third most common musculoskeletal problem and accounts for 5% of general practitioner consultations. Although many treatments are described, there is no consensus on optimal treatment and up to 40% of patients still have pain 12 months after initially seeking help for pain. Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT. Patients were assessed at 4 and 12 weeks by a blinded observer and compared with baseline. We observed sustained reductions in pain at night, pain with activity, and functional improvement at 4 and 12 weeks with active but not sham TCPRFT. The 25 subjects who received active treatment showed statistically significant reductions of 24/100 in pain at night and 20/100 of pain with activity at 4 weeks and 18/100 and 19/100, respectively, at 12 weeks from baseline. Statistically significant lower Brief Pain Inventory pain and function scores (4 and 12 weeks), improved pain self-efficacy (4 weeks), Oxford Shoulder scores (12 weeks), and internal rotation (12 weeks) were seen. Pain at both rest and shoulder elevation were not improved by active treatment. No complications were seen. This study of a simple, low risk, outpatient treatment confirms the findings of our earlier study of TCPRFT for knee pain and shoulder pain audit that transcutaneous pulsed radiofrequency treatment may help some people with painful shoulders. © 2013 The Authors Pain Practice © 2013 World Institute of Pain.

Short- and long-term effects of mud-bath treatment on hand osteoarthritis: a randomized clinical trial

NASA Astrophysics Data System (ADS)

Fioravanti, Antonella; Tenti, Sara; Giannitti, Chiara; Fortunati, Nicola Angelo; Galeazzi, Mauro

2014-01-01

The aim of this study was to evaluate both the short-term and the long-term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA). This was a prospective randomized, single blind controlled trial. Sixty outpatients with primary bilateral hand OA were included in the study and randomized to one of two groups. One group ( n = 30) was treated with 12 daily local mud packs and generalized thermal baths with a sulfate-calcium-magnesium-fluorides mineral water added to usual treatment. The control group ( n = 30) continued regular outpatient care routine (exercise, NSAIDs and/or analgesics). Each patient was examined at baseline, after 2 weeks, and after 3, 6, 9 and 12 months. Primary outcome measures were global spontaneous hand pain on a visual analogue scale (VAS) and the functional index for hand osteoarthritis (FIHOA) score; secondary outcomes were health assessment questionnaire (HAQ), duration of morning stiffness, medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption. Our results demonstrated that the efficacy of spa therapy was significant in all the assessed parameters, both at the end of therapy and after 3 months; the values of FIHOA, HAQ and drugs consumption continued to be significantly better after 6 months in comparison with baseline. There were no significant modifications of the parameters throughout the follow-up in the control group. Differences between the two groups were significant for all parameters at the 15th day and at 3 months follow-up; regarding FIHOA, HAQ, and symptomatic drugs consumption, the difference between the two groups persisted and was significant at 6month follow-up. Tolerability of spa therapy seemed to be good. In conclusion, our results confirm that the beneficial effects of spa therapy in patients with hand OA last over time.

Effect of whole soy and purified daidzein on ambulatory blood pressure and endothelial function--a 6-month double-blind, randomized controlled trial among Chinese postmenopausal women with prehypertension.

PubMed

Liu, Z-M; Ho, S C; Chen, Y-M; Tomlinson, B; Ho, S; To, K; Woo, J

2015-10-01

Although observational studies suggest that soy foods or isoflavones are cardio-protective, clinical trials on whole soy or isoflavone daidzein (one major isoflavone and the precursor of equol) on blood pressure (BP) and endothelial function (EF) are few and have not been specifically conducted among equol producers, a population most likely to benefit from soy treatment. We performed a 6-month double-blind, randomized, placebo-controlled trial to examine the effect of whole soy (soy flour) or purified daidzein on BP and EF in prehypertensive or untreated hypertensive postmenopausal women verified to be equol producers. A total of 270 eligible women were recruited and randomized to either one of the three treatment groups, 40 g soy flour (whole soy group), 40 g low-fat milk powder+63 mg daidzein (daidzein group) or 40 g low-fat milk powder (active control group) daily, each given as a solid beverage powder for 6 months. The primary outcome measures were 24 h ambulatory BP (ABP) and EF assessed by flow-mediated dilation using brachial artery ultrasound. A total of 253 subjects completed the study according to protocol. Urinary isoflavones indicated good compliance with the interventions. Intention to treat and per-protocol analysis indicated that there was no significant difference in the 6-month changes or % changes in parameters of ABP and brachial flow-mediated dilation among the three treatment groups. A further subgroup analysis among hypertensive women (n=138) did not alter the conclusions. Whole soy and purified daidzein had no significant effect on BP and vascular function among equol-producing postmenopausal women with prehypertension or untreated hypertension.

Three-unit posterior zirconia-ceramic fixed dental prostheses (FDPs) veneered with layered and milled (CAD-on) veneering ceramics: 1-year follow-up of a randomized controlled clinical trial.

PubMed

Grohmann, Philipp; Bindl, Andreas; Hämmerle, Christoph; Mehl, Albert; Sailer, Irena

2015-01-01

The aim of this multicenter randomized controlled clinical trial was to test posterior zirconia-ceramic fixed dental prostheses (FDPs) veneered with a computer-aided design/computer- assisted manufacture (CAD/CAM) lithium disilicate veneering ceramic (CAD-on) and manually layered zirconia veneering ceramic with respect to survival of the FDPs, and technical and biologic outcomes. Sixty patients in need of one posterior three-unit FDP were included. The zirconia frameworks were produced with a CAD/CAM system (Cerec inLab 3D/Cerec inEOS inLab). Thirty FDPs were veneered with a CAD/CAM lithium disilicate veneering ceramic (Cad-on) (test) and 30 were veneered with a layered zirconia veneering ceramic (control). For the clinical evaluation at baseline, 6, and 12 months, the United States Public Health Service (USPHS) criteria were used. The biologic outcome was judged by comparing the plaque control record (PCR), bleeding on probing (BOP), and probing pocket depth (PPD). Data were statistically analyzed. Fifty-six patients were examined at a mean follow-up of 13.9 months. At the 1-year follow-up the survival rate was 100% in the test and in the control group. No significant differences of the technical outcomes occurred. Major chipping occurred in the control group (n = 3) and predominantly minor chipping in the test group (minor n = 2, major n = 1). No biologic problems or differences were found. Both types of zirconia-ceramic FDPs exhibited very good clinical outcomes without differences between groups. Chipping occurred in both types of FDPs at small amounts, yet the extension of the chippings differed. The test FDPs predominantly exhibited minor chipping, the control FDPs major chipping.

DO CONSUMER PRICE SUBSIDIES REALLY IMPROVE NUTRITION?*

PubMed Central

Jensen, Robert T.; Miller, Nolan H.

2010-01-01

Many developing countries use food-price subsidies or controls to improve nutrition. However, subsidizing goods on which households spend a high proportion of their budget can create large wealth effects. Consumers may then substitute towards foods with higher non-nutritional attributes (e.g., taste), but lower nutritional content per unit of currency, weakening or perhaps even reversing the subsidy’s intended impact. We analyze data from a randomized program of large price subsidies for poor households in two provinces of China and find no evidence that the subsidies improved nutrition. In fact, it may have had a negative impact for some households. (JEL I38; O12; Q18) PMID:22505779

Effectiveness of mindfulness meditation (Vipassana) in the management of chronic low back pain

PubMed Central

Patil, Sangram G

2009-01-01

Summary Chronic low back pain (CLBP) is challenging to treat with its significant psychological and cognitive behavioural element involved. Mindfulness meditation helps alter the behavioural response in chronic pain situations. Significant body of research in the filed of mindfulness meditation comes from the work of Dr Kabat-Zinn. The current evidence in the field, though not grade one, shows that there is a place for mindfulness meditation in managing chronic pain conditions including CLBP. Further research to test the usefulness of mindfulness in CLBP should involve good quality randomized controlled trials of pure mindfulness based technique in matched subjects. PMID:20640116

Analysis of reliable sub-ns spin-torque switching under transverse bias magnetic fields

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

D'Aquino, M., E-mail: daquino@uniparthenope.it; Perna, S.; Serpico, C.

2015-05-07

The switching process of a magnetic spin-valve nanosystem subject to spin-polarized current pulses is considered. The dependence of the switching probability on the current pulse duration is investigated. The further application of a transverse field along the intermediate anisotropy axis of the particle is used to control the quasi-random relaxation of magnetization to the reversed magnetization state. The critical current amplitudes to realize the switching are determined by studying the phase portrait of the Landau-Lifshtz-Slonczewski dynamics. Macrospin numerical simulations are in good agreement with the theoretical prediction and demonstrate reliable switching even for very short (below 100 ps) current pulses.

Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study.

PubMed

Wang, Man; Tong, Jian-hua; Zhu, Gang; Liang, Guang-ming; Yan, Hong-fei; Wang, Xiu-zhen

2012-06-01

To evaluate the efficacy of metformin for treatment of antipsychotic-induced weight gain. Seventy-two patients with first-episode schizophrenia who gained more than 7% of their predrug weight were randomly assigned to receive 1000 mg/d of metformin or placebo in addition to their ongoing treatment for 12 weeks using a double-blind study design. The primary outcome was change in body weight. The secondary outcomes included changes in body mass index, fasting glucose and insulin, and insulin resistance index. Of the 72 patients who were randomly assigned, 66 (91.6%) completed treatments. The body weight, body mass index, fasting insulin and insulin resistance index decreased significantly in the metformin group, but increased in the placebo group during the 12-week follow-up period. Significantly more patients in the metformin group lost their baseline weight by more than 7%, which was the cutoff for clinically meaningful weight loss. Metformin was tolerated well by majority patients. Metformin was effective and safe in attenuating antipsychotic-induced weight gain and insulin resistance in first-episode schizophrenia patients. Patients displayed good adherence to metformin. Copyright © 2012 Elsevier B.V. All rights reserved.

Scaling of Device Variability and Subthreshold Swing in Ballistic Carbon Nanotube Transistors

NASA Astrophysics Data System (ADS)

Cao, Qing; Tersoff, Jerry; Han, Shu-Jen; Penumatcha, Ashish V.

2015-08-01

In field-effect transistors, the inherent randomness of dopants and other charges is a major cause of device-to-device variability. For a quasi-one-dimensional device such as carbon nanotube transistors, even a single charge can drastically change the performance, making this a critical issue for their adoption as a practical technology. Here we calculate the effect of the random charges at the gate-oxide surface in ballistic carbon nanotube transistors, finding good agreement with the variability statistics in recent experiments. A combination of experimental and simulation results further reveals that these random charges are also a major factor limiting the subthreshold swing for nanotube transistors fabricated on thin gate dielectrics. We then establish that the scaling of the nanotube device uniformity with the gate dielectric, fixed-charge density, and device dimension is qualitatively different from conventional silicon transistors, reflecting the very different device physics of a ballistic transistor with a quasi-one-dimensional channel. The combination of gate-oxide scaling and improved control of fixed-charge density should provide the uniformity needed for large-scale integration of such novel one-dimensional transistors even at extremely scaled device dimensions.

Echo Statistics of Aggregations of Scatterers in a Random Waveguide: Application to Biologic Sonar Clutter

DTIC Science & Technology

2012-09-01

used in this paper to compare probability density functions, the Lilliefors test and the Kullback - Leibler distance. The Lilliefors test is a goodness ... of interest in this study are the Rayleigh distribution and the exponential distribution. The Lilliefors test is used to test goodness - of - fit for...Lilliefors test for goodness of fit with an exponential distribution. These results suggests that,

Itopride therapy for functional dyspepsia: A meta-analysis

PubMed Central

Huang, Xuan; Lv, Bin; Zhang, Shuo; Fan, Yi-Hong; Meng, Li-Na

2012-01-01

AIM: To evaluate the therapeutic effects of itopride vs other drugs (placebo, domperidone, mosapride) for functional dyspepsia (FD). METHODS: Randomized controlled trials (RCTs) of itopride for FD were retrieved from databases. Relevant information was extracted and analyzed, using the relative risk (RR) and weighted mean deviation, as appropriate. A random or fixed effect model was used, based on the heterogeneity of the included articles, and visual inspection of funnel plots was used to evaluate publication bias. RESULTS: Nine RCTs enrolling 2620 FD cases were included; 1372 cases received itopride treatment and 1248 cases received placebo or other drugs (control groups). Compared with control groups, itopride had superior RR values of 1.11 [95%CI: (1.03, 1.19), P = 0.006], 1.21 [95%CI: (1.03, 1.44), P = 0.02], and 1.24 [95%CI: (1.01, 1.53), P = 0.04] for global patient assessment, postprandial fullness, and early satiety, respectively. For the Leeds Dyspepsia Questionnaire score, the weighted mean deviation was -1.38 [95%CI: (-1.75, -1.01), P < 0.01]. The incidence of adverse effects was similar in the itopride and control groups. The funnel plots for all indicators showed no evidence of publication bias. CONCLUSION: Itopride has good efficacy in terms of global patients assessment, postprandial fullness, and early satiety in the treatment of patients with FD and shows a low rate of adverse reactions. Itopride can greatly improve FD syndromes-score. PMID:23326147

Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: an international multicenter study.

PubMed

Mahler, Michael; Radice, Antonella; Sinico, Renato A; Damoiseaux, Jan; Seaman, Andrea; Buckmelter, Kristen; Vizjak, Alenka; Buchner, Carol; Binder, Walter L; Fritzler, Marvin J; Cui, Zhao

2012-01-01

Autoantibodies to the non-collagen region (NC1) of the alpha-3 subunit of collagen IV represent a serological hallmark in the diagnosis of Goodpasture's syndrome (GPS). The objective of our study was to carefully analyze the performance characteristics of a novel anti-glomerular basement membrane (GBM) chemiluminescence immunoassay (CIA). Sera from patients with GPS (n = 90) were collected from four clinical centers. Samples from different disease groups (n = 397) and healthy individuals (n = 400) were used as controls. All samples were tested for anti-GBM antibodies by a rapid, random access CIA (QUANTA Flash™ GBM). Most of the samples were also tested using other methods including different commercial anti-GBM IgG assays and research assays for anti-GBM IgA and IgM. The sensitivity and specificity of the novel CIA was 95.6% [95% confidence interval (CI) 89.0-98.8%] and 99.6% (95% CI 98.9-99.9%), respectively. Receiver operating characteristic analysis showed good discrimination between GPS patients and controls. The area under the curve was 0.98 (CI 0.96-1.0). The three anti-GBM antibody-positive samples from the control group were from two healthy individuals and one human immunodeficiency virus (HIV)-infected patient. All three individuals had low levels of anti-GBM antibodies [20, 24 and 25 chemiluminescent unit (CU), cutoff 20 CU]. When the results of the new CIA were compared to other methods, good agreement was observed: 95.8% (kappa = 0.92) versus EliA™ GBM, 97.4% (kappa = 0.95) versus both BINDAZYME™ Anti-GBM and QUANTA Lite® GBM. Anti-GBM IgA was detectable in low concentrations in patients with GPS and was associated with anti-GBM IgG but was less useful in discriminating GPS patients and controls. No discrimination was found for anti-GBM IgM. The novel QUANTA Flash™ GBM CIA demonstrated good sensitivity and specificity and had good agreement with other methods. Our data confirm that ∼5% of patients with GPS do not have detectable levels of anti-GBM antibodies.

What would you do? The effect of verbal persuasion on task choice.

PubMed

Lamarche, Larkin; Gionfriddo, Alicia M; Cline, Lindsay E; Gammage, Kimberley L; Adkin, Allan L

2014-01-01

Verbal persuasion has been shown to influence psychological and behavioral outcomes. The present study had two objectives: (1) to examine the effect of verbal persuasion on task choice in a balance setting and (2) to evaluate the use of verbal persuasion as an approach to experimentally induce mismatches between perceived and actual balance. Healthy young adults (N=68) completed an 8-m tandem walk task without vision and then were randomly assigned to a feedback group (good, control, or poor), regardless of actual balance. Following the feedback, participants chose to perform the task in one of three conditions differing in level of challenge and also were required to perform the task under the same pre-feedback conditions. Balance efficacy and perceived stability were rated before and after each pre- and post-feedback task, respectively. Balance performance measures were also collected. Following the feedback, participants in the good group were more likely to choose the most challenging task while those in the poor group were more likely to choose the least challenging task. Following the feedback, all groups showed improved balance performance. However, balance efficacy and perceived stability increased for the good and control groups but balance efficacy decreased and perceived stability was unchanged for the poor group. Thus, these findings demonstrate that verbal persuasion can influence task choice and may be used as an approach to experimentally create mismatches between perceived and actual balance. Copyright © 2013 Elsevier B.V. All rights reserved.

RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial.

PubMed

Burbach, J P Maarten; Verkooijen, Helena M; Intven, Martijn; Kleijnen, Jean-Paul J E; Bosman, Mirjam E; Raaymakers, Bas W; van Grevenstein, Wilhelmina M U; Koopman, Miriam; Seravalli, Enrica; van Asselen, Bram; Reerink, Onne

2015-02-22

Treatment for locally advanced rectal cancer (LARC) consists of chemoradiation therapy (CRT) and surgery. Approximately 15% of patients show a pathological complete response (pCR). Increased pCR-rates can be achieved through dose escalation, thereby increasing the number patients eligible for organ-preservation to improve quality of life (QoL). A randomized comparison of 65 versus 50Gy with external-beam radiation alone has not yet been performed. This trial investigates pCR rate, clinical response, toxicity, QoL and (disease-free) survival in LARC patients treated with 65Gy (boost + chemoradiation) compared with 50Gy standard chemoradiation (sCRT). This study follows the 'cohort multiple randomized controlled trial' (cmRCT) design: rectal cancer patients are included in a prospective cohort that registers clinical baseline, follow-up, survival and QoL data. At enrollment, patients are asked consent to offer them experimental interventions in the future. Eligible patients-histologically confirmed LARC (T3NxM0 <1 mm from mesorectal fascia, T4NxM0 or TxN2M0) located ≤10 cm from the anorectal transition who provided consent for experimental intervention offers-form a subcohort (n = 120). From this subcohort, a random sample is offered the boost prior to sCRT (n = 60), which they may accept or refuse. Informed consent is signed only after acceptance of the boost. Non-selected patients in the subcohort (n = 60) undergo sCRT alone and are not notified that they participate in the control arm until the trial is completed. sCRT consists of 50Gy (25 × 2Gy) with concomitant capecitabine. The boost (without chemotherapy) is given prior to sCRT and consists of 15 Gy (5 × 3Gy) delivered to the gross tumor volume (GTV). The primary endpoint is pCR (TRG 1). Secondary endpoints include acute grade 3-4 toxicity, good pathologic response (TRG 1-2), clinical response, surgical complications, QoL and (disease-free) survival. Data is analyzed by intention to treat. The boost is delivered prior to sCRT so that GTV adjustment for tumor shrinkage during sCRT is not necessary. Small margins also aim to limit irradiation of healthy tissue. The cmRCT design provides opportunity to overcome common shortcomings of classic RCTs, such as slow recruitment, disappointment-bias in control arm patients and poor generalizability. The Netherlands Trials Register NL46051.041.13. Registered 22 August 2013. ClinicalTrials.gov NCT01951521 . Registered 18 September 2013.

[Dexpanthenol nasal spray as an effective therapeutic principle for treatment of rhinitis sicca anterior].

PubMed

Kehrl, W; Sonnemann, U

1998-09-01

Controlled clinical studies on medical treatment of rhinitis sicca anterior have not yet been published. Therapy recommendations are based on experiences but not on results of controlled clinical studies. The aim of this study was to examine the efficacy and tolerance of a new form of application of Dexpanthenol in physiologic saline solution (Nasicur). A randomized comparison of parallel groups was performed. One group was treated with the nasal spray while the control group received a placebo. The assessment of nasal breathing resistance and the extent of crust formation according to scores were defined as target parameters. Statistical analysis was carried out according to Wilcoxon at alpha < or = 0.05. Forty-eight outpatients diagnosed with rhinitis sicca anterior were included in this study. Twenty-four received the medication, and 29 were treated with a placebo. The superiority of the dexpanthenol nasal spray in comparison to the placebo medication was demonstrated for both target parameters as clinically relevant and statistically significant. The placebo spray showed clinical improvement of the other treatment outcome parameters. Dexpanthenol nasal spray showed no statistically significant difference in comparison to placebo. The clinically proven efficacy is emphasized by good tolerance of both treatments which was validated by the objective rhinoscopy findings. Good compliance was confirmed. The result of the controlled clinical study confirms that the dexpanthenol nasal spray is an effective medicinal treatment of rhinitis sicca anterior and is more effective than common medications.

Making a measurable difference in advanced Huntington disease care.

PubMed

Moskowitz, Carol Brown; Rao, Ashwini K

2017-01-01

Neurologists' role in the care of people with advanced Huntington disease (HD) (total functional capacity <7), often limited by a lack of clinical research to support good practice, includes the following: (1) provide comprehensive health records to an interdisciplinary care staff before admission to a more intense care setting (home health services, day program, assisted living, group home, long-term skilled nursing facility, palliative care); (2) consult with and refer to rehabilitation (occupational therapy, physical therapy, speech and language pathology), behavioral and psychiatric professionals for problem-solving strategies, which must be reviewed with direct care staff before implementation; (3) encourage and support qualitative and quantitative interdisciplinary research studies, and randomized controlled studies of nonpharmacologic interventions; and (4) assist in the development of meaningful measures to further document what works to provide a good quality of life for the patient and family and a comfortable thoughtful approach to a good death. Collaborative models of care depend on: (1) clear communication; (2) ongoing education and support programs; with (3) pharmacologic and rehabilitation interventions, always in the context of respect for the person with HD, a preservation of the individuals' dignity, autonomy, and individual preferences. Copyright © 2017 Elsevier B.V. All rights reserved.

Factors Associated with Successful Functioning in American Indian Youths

ERIC Educational Resources Information Center

Silmere, Hile; Stiffman, Arlene Rubin

2006-01-01

This study examines environmental and cultural factors related to successful functioning in a stratified random sample of 401 American Indian youths. The success index included seven indicators: good mental health, being alcohol and drug free, absence of serious misbehavior, clean police record, good grades, positive psychosocial functioning, and…

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

Safety, efficacy, actions, and patient acceptability of drospirenone/ethinyl estradiol contraceptive pills in the treatment of premenstrual dysphoric disorder.

PubMed

Breech, Lesley L; Braverman, Paula K

2010-08-09

Premenstrual dysphoric disorder (PMDD) is estimated to affect 3%-8% of reproductive age women. Multiple therapeutic modalities have been evaluated with varying efficacy for the associated somatic and mood symptoms. The majority of older studies had shown that oral contraceptive pills (OCs) were most effective for the physical symptoms. However, newer OCs containing a novel progestin, drospirenone, have shown promise in alleviating both the somatic and affective/behavioral symptoms. This progestin, which is a derivative of spironolactone, has both antimineralocorticoid and antiandrogenic activity. A 24/4 formulation containing 20 μg of ethinyl estradiol has been found effective in randomized double-blind placebo-controlled trials utilizing established scales documenting symptoms associated with PMDD. Multiple studies have shown that drospirenone-containing OCs are safe without evidence of clinically adverse effects on carbohydrate metabolism, lipids, blood pressure, weight, serum potassium or increased thrombotic events compared to other low dose OCs. In addition, significant improvements have been demonstrated in acne, hirsutism, and fluid retention symptoms. Several open label studies demonstrated good patient compliance and reported satisfaction with the method. Because of the significant placebo effect demonstrated in the blinded placebo-controlled trials, additional large randomized placebo-controlled trials are needed to confirm the efficacy of the drospirenone OCs in the treatment of PMDD. However, this OC formulation appears to be a promising therapeutic modality.

Safety, efficacy, actions, and patient acceptability of drospirenone/ethinyl estradiol contraceptive pills in the treatment of premenstrual dysphoric disorder

PubMed Central

Breech, Lesley L; Braverman, Paula K

2010-01-01

Premenstrual dysphoric disorder (PMDD) is estimated to affect 3%–8% of reproductive age women. Multiple therapeutic modalities have been evaluated with varying efficacy for the associated somatic and mood symptoms. The majority of older studies had shown that oral contraceptive pills (OCs) were most effective for the physical symptoms. However, newer OCs containing a novel progestin, drospirenone, have shown promise in alleviating both the somatic and affective/behavioral symptoms. This progestin, which is a derivative of spironolactone, has both antimineralocorticoid and antiandrogenic activity. A 24/4 formulation containing 20 μg of ethinyl estradiol has been found effective in randomized double-blind placebo-controlled trials utilizing established scales documenting symptoms associated with PMDD. Multiple studies have shown that drospirenone-containing OCs are safe without evidence of clinically adverse effects on carbohydrate metabolism, lipids, blood pressure, weight, serum potassium or increased thrombotic events compared to other low dose OCs. In addition, significant improvements have been demonstrated in acne, hirsutism, and fluid retention symptoms. Several open label studies demonstrated good patient compliance and reported satisfaction with the method. Because of the significant placebo effect demonstrated in the blinded placebo-controlled trials, additional large randomized placebo-controlled trials are needed to confirm the efficacy of the drospirenone OCs in the treatment of PMDD. However, this OC formulation appears to be a promising therapeutic modality. PMID:21072278

Outcome Evaluation of Family Eats.

PubMed

Cullen, Karen Weber; Thompson, Debbe; Chen, Tzu-An

2017-02-01

This article presents the results of a randomized clinical trial evaluating the eight-session Family Eats web-based intervention promoting healthy home food environments for African American families. African American families ( n = 126) with 8- to 12-year-old children completed online baseline questionnaires and were randomized into intervention or control groups. Data collection occurred at baseline, immediately postintervention (Post 1), and 4 months later (Post 2), for parents and children, separately. There were two group by time intervention effects: Control group parents reported a significantly greater frequency of drinking 100% fruit juice at Post 1 compared with intervention group parents. Parent menu planning skills were significantly higher at Post 2 for the intervention group compared with the control group. Significant positive changes overtime were noted for both groups for home fruit/vegetable availability, food preparation practices, and healthy restaurant selection. Intervention group children reported a significant increase in home juice availability at Post 1 compared with the control group; home fruit availability improved for both groups. There was no difference in log on rates by group: 84% and 86% for those who completed Post 1 and Post 2 measurements, respectively. Sixty-four participants completed the evaluation survey: 17 control (50%) and 47 intervention (51%) participants. All participants reported liking the program components; all but one gave it an A or B grade. An Internet-delivered nutrition intervention for families was successful in achieving change in some mediating variables, with good log on rates. Future research with Family Eats should include larger sample sizes, with longer follow-up and a more objective measure of diet.

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

PubMed

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

2012-09-07

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

Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial.

PubMed

Long, Judith A; Jahnle, Erica C; Richardson, Diane M; Loewenstein, George; Volpp, Kevin G

2012-03-20

Compared with white persons, African Americans have a greater incidence of diabetes, decreased control, and higher rates of microvascular complications. A peer mentorship model could be a scalable approach to improving control in this population and reducing disparities in diabetic outcomes. To determine whether peer mentors or financial incentives are superior to usual care in helping African American veterans decrease their hemoglobin A(1c) (HbA(1c)) levels. A 6-month randomized, controlled trial. (ClinicalTrials.gov registration number: NCT01125956) Philadelphia Veterans Affairs Medical Center. African American veterans aged 50 to 70 years with persistently poor diabetes control. 118 patients were randomly assigned to 1 of 3 groups: usual care, a peer mentoring group, and a financial incentives group. Usual care patients were notified of their starting HbA(1c) level and recommended goals for HbA(1c). Those in the peer mentoring group were assigned a mentor who formerly had poor glycemic control but now had good control (HbA(1c) level ≤7.5%). The mentor was asked to talk with the patient at least once per week. Peer mentors were matched by race, sex, and age. Patients in the financial incentive group could earn $100 by decreasing their HbA(1c) level by 1% and $200 by decreasing it by 2% or to an HbA(1c) level of 6.5%. Change in HbA(1c) level at 6 months. Mentors and mentees talked the most in the first month (mean calls, 4; range, 0 to 30), but calls decreased to a mean of 2 calls (range, 0 to 10) by the sixth month. Levels of HbA(1c) decreased from 9.9% to 9.8% in the control group, from 9.8% to 8.7% in the peer mentor group, and from 9.5% to 9.1% in the financial incentive group. Mean change in HbA(1c) level from baseline to 6 months relative to control was -1.07% (95% CI, -1.84% to -0.31%) in the peer mentor group and -0.45% (CI, -1.23% to 0.32%) in the financial incentive group. The study included only veterans and lasted only 6 months. Peer mentorship improved glucose control in a cohort of African American veterans with diabetes. National Institute on Aging Roybal Center.

The frequency hopping pattern design for random hopping frequency signal based on stationary phase principle

NASA Astrophysics Data System (ADS)

Liao, Zhikun; Lu, Dawei; Hu, Jiemin; Zhang, Jun

2018-04-01

For the random hopping frequency signal, the modulated frequencies are randomly distributed over given bandwidth. The randomness of modulated frequency not only improves the electronic counter countermeasure capability for radar systems, but also determines its performance of range compression. In this paper, the range ambiguity function of RHF signal is firstly derived. Then, a design method of frequency hopping pattern based on stationary phase principle to improve the peak to side-lobe ratio is proposed. Finally, the simulated experiments show a good effectiveness of the presented design method.

Canine model of crush syndrome established by a digital crush injury device platform

PubMed Central

Song, Jie; Ding, Hui; Fan, Hao-Jun; Dong, Wen-Long; Sun, Zhen-Xing; Hou, Shi-Ke

2015-01-01

Objective: To establish a canine model of crush syndrome (CS). Methods: A total of 16 healthy adult female Beagle dogs were randomly divided into the control group (n=8) and the experimental group (n=8). The crush injury was created in the left hind leg of each dog in the experimental group. Results: The biochemical indexes in the experimental group changed significantly compared to the values before extrusion. And they were also significantly different from the values of the control group. The glomerular capillary dilation, renal tubular epithelial cell degeneration, and renal interstitial lymphocytic infiltration were found in the kidneys. Conclusion: The canine CS model established by the digital crush injury device platform was successful according with the diagnosis of CS. It is good for the investigation of the CS mechanism and treatment using this model. PMID:26261489

[Cannabinoids in pain medicine].

PubMed

Karst, M

2018-06-07

The endocannabinoid system (ECS) controls a large number of vital functions. Suboptimal tone of the ECS in certain regions of the nervous system may be associated with disorders that are also associated with pain. Pain and inflammation processes can be modulated by the exogenous supply of cannabinoids. Low-to-moderate pain-relieving effects and in individual cases large pain-relieving effects were observed in randomized, controlled studies of various types of chronic pain. People with chronic neuropathic pain and stress symptoms seem to particularly benefit. The therapeutic range of cannabinoids is small; often small doses are sufficient for clinically significant effects. The "Cannabis-als-Medizin-Gesetz" (cannabis as medicine law) allows the prescription of cannabis preparations under certain conditions. Available data indicate good long-term efficacy and tolerability. However, there is little systematic long-term experience from clinical studies.

[Behavior and cognitive treatments for insomnia. An alternative to pharmacotherapy].

PubMed

Baillargeon, L

1997-02-01

To familiarize family physicians with cognitive and behavioural treatments for insomnia. MEDLINE was searched from 1983 to 1995 and Psychlit from 1974 to 1995 using the key words "behaviour therapy," "cognitive therapy," "phototherapy," and "insomnia." We chose randomized trials and meta-analyses on the treatment of insomnia. Information was extracted on time-lag before sleep, frequency and duration of wakeful periods during the night, consumption of hynotics, and subjects' own assessment of their sleep before and after treatment. The most effective interventions were relaxation training, sleep restriction, and stimulus control. Practising good sleeping habits was only somewhat effective and should always be used in conjunction with other interventions. Stimulus control for insomnia has been demonstrated to be effective when used by primary care physicians. Other nonpharmacologic treatments should be evaluated in a similar manner.

Alignment of gold nanorods by angular photothermal depletion

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

Taylor, Adam B.; Chow, Timothy T. Y.; Chon, James W. M., E-mail: jchon@swin.edu.au

2014-02-24

In this paper, we demonstrate that a high degree of alignment can be imposed upon randomly oriented gold nanorod films by angular photothermal depletion with linearly polarized laser irradiation. The photothermal reshaping of gold nanorods is observed to follow quadratic melting model rather than the threshold melting model, which distorts the angular and spectral hole created on 2D distribution map of nanorods to be an open crater shape. We have accounted these observations to the alignment procedures and demonstrated good agreement between experiment and simulations. The use of multiple laser depletion wavelengths allowed alignment criteria over a large range ofmore » aspect ratios, achieving 80% of the rods in the target angular range. We extend the technique to demonstrate post-alignment in a multilayer of randomly oriented gold nanorod films, with arbitrary control of alignment shown across the layers. Photothermal angular depletion alignment of gold nanorods is a simple, promising post-alignment method for creating future 3D or multilayer plasmonic nanorod based devices and structures.« less

A Novel Ni/WOX/W Resistive Random Access Memory with Excellent Retention and Low Switching Current

NASA Astrophysics Data System (ADS)

Chien, Wei-Chih; Chen, Yi-Chou; Lee, Feng-Ming; Lin, Yu-Yu; Lai, Erh-Kun; Yao, Yeong-Der; Gong, Jeng; Horng, Sheng-Fu; Yeh, Chiao-Wen; Tsai, Shih-Chang; Lee, Ching-Hsiung; Huang, Yu-Kai; Chen, Chun-Fu; Kao, Hsiao-Feng; Shih, Yen-Hao; Hsieh, Kuang-Yeu; Lu, Chih-Yuan

2011-04-01

The behavior of WOX resistive random access memory (ReRAM) is a strong function of the top electrode material, which controls the conduction mechanism and the forming process. When using a top electrode with low work function, the current conduction is limited by space charges. On the other hand, the mechanism becomes thermionic emission for devices with a high work function top electrode. These (thermionic) devices are also found to have higher initial resistance, reduced forming current, and larger resistance window. Based on these insights and considering the compatibility to complementary metal-oxide-semiconductor (CMOS) process, we proposed to use Ni as the top electrode for high performance WOX ReRAM devices. The new Ni/WOX/W device can be switched at a low current density less than 8×105 A/cm2, with RESET/SET resistance ratio greater than 100, and extremely good data retention of more than 300 years at 85 °C.

OCT Amplitude and Speckle Statistics of Discrete Random Media.

PubMed

Almasian, Mitra; van Leeuwen, Ton G; Faber, Dirk J

2017-11-01

Speckle, amplitude fluctuations in optical coherence tomography (OCT) images, contains information on sub-resolution structural properties of the imaged sample. Speckle statistics could therefore be utilized in the characterization of biological tissues. However, a rigorous theoretical framework relating OCT speckle statistics to structural tissue properties has yet to be developed. As a first step, we present a theoretical description of OCT speckle, relating the OCT amplitude variance to size and organization for samples of discrete random media (DRM). Starting the calculations from the size and organization of the scattering particles, we analytically find expressions for the OCT amplitude mean, amplitude variance, the backscattering coefficient and the scattering coefficient. We assume fully developed speckle and verify the validity of this assumption by experiments on controlled samples of silica microspheres suspended in water. We show that the OCT amplitude variance is sensitive to sub-resolution changes in size and organization of the scattering particles. Experimentally determined and theoretically calculated optical properties are compared and in good agreement.

Adherence Rating Scale for Cognitive Processing Therapy - Cognitive Only: Analysis of Psychometric Properties.

PubMed

Dittmann, Clara; Müller-Engelmann, Meike; Resick, Patricia A; Gutermann, Jana; Stangier, Ulrich; Priebe, Kathlen; Fydrich, Thomas; Ludäscher, Petra; Herzog, Julia; Steil, Regina

2017-11-01

The assessment of therapeutic adherence is essential for accurately interpreting treatment outcomes in psychotherapy research. However, such assessments are often neglected. To fill this gap, we aimed to develop and test a scale that assessed therapeutic adherence to Cognitive Processing Therapy - Cognitive Only (CPT), which was adapted for a treatment study targeting patients with post-traumatic stress disorder and co-occurring borderline personality symptoms. Two independent, trained raters assessed 30 randomly selected treatment sessions involving seven therapists and eight patients who were treated in a multicentre randomized controlled trial. The inter-rater reliability for all items and the total score yielded good to excellent results (intraclass correlation coefficient [ICC] = 0.70 to 1.00). Cronbach's α was .56 for the adherence scale. Regarding content validity, three experts confirmed the relevance and appropriateness of each item. The adherence rating scale for the adapted version of CPT is a reliable instrument that can be helpful for interpreting treatment effects, analysing possible relationships between therapeutic adherence and treatment outcomes and teaching therapeutic skills.

Chemotherapy in advanced ovarian cancer: four systematic meta-analyses of individual patient data from 37 randomized trials. Advanced Ovarian Cancer Trialists' Group.

PubMed Central

Aabo, K.; Adams, M.; Adnitt, P.; Alberts, D. S.; Athanazziou, A.; Barley, V.; Bell, D. R.; Bianchi, U.; Bolis, G.; Brady, M. F.; Brodovsky, H. S.; Bruckner, H.; Buyse, M.; Canetta, R.; Chylak, V.; Cohen, C. J.; Colombo, N.; Conte, P. F.; Crowther, D.; Edmonson, J. H.; Gennatas, C.; Gilbey, E.; Gore, M.; Guthrie, D.; Yeap, B. Y.

1998-01-01

The purpose of this systematic study was to provide an up to date and reliable quantitative summary of the relative benefits of various types of chemotherapy (non-platinum vs platinum, single-agent vs combination and carboplatin vs cisplatin) in the treatment of advanced ovarian cancer. Also, to investigate whether well-defined patient subgroups benefit more or less from cisplatin- or carboplatin-based therapy. Meta-analyses were based on updated individual patient data from all available randomized controlled trials (published and unpublished), including 37 trials, 5667 patients and 4664 deaths. The results suggest that platinum-based chemotherapy is better than non-platinum therapy, show a trend in favour of platinum combinations over single-agent platinum, and suggest that cisplatin and carboplatin are equally effective. There is no good evidence that cisplatin is more or less effective than carboplatin in any particular subgroup of patients. Images Figure 1 Figure 2 Figure 3 PMID:9836481

Human cooperation by lethal group competition

PubMed Central

Egas, Martijn; Kats, Ralph; van der Sar, Xander; Reuben, Ernesto; Sabelis, Maurice W.

2013-01-01

Why humans are prone to cooperate puzzles biologists, psychologists and economists alike. Between-group conflict has been hypothesized to drive within-group cooperation. However, such conflicts did not have lasting effects in laboratory experiments, because they were about luxury goods, not needed for survival (“looting”). Here, we find within-group cooperation to last when between-group conflict is implemented as “all-out war” (eliminating the weakest groups). Human subjects invested in helping group members to avoid having the lowest collective pay-off, whereas they failed to cooperate in control treatments with random group elimination or with no subdivision in groups. When the game was repeated, experience was found to promote helping. Thus, not within-group interactions alone, not random group elimination, but pay-off-dependent group elimination was found to drive within-group cooperation in our experiment. We suggest that some forms of human cooperation are maintained by multi-level selection: reciprocity within groups and lethal competition among groups acting together. PMID:23459158

Layout decomposition of self-aligned double patterning for 2D random logic patterning

NASA Astrophysics Data System (ADS)

Ban, Yongchan; Miloslavsky, Alex; Lucas, Kevin; Choi, Soo-Han; Park, Chul-Hong; Pan, David Z.

2011-04-01

Self-aligned double pattering (SADP) has been adapted as a promising solution for sub-30nm technology nodes due to its lower overlay problem and better process tolerance. SADP is in production use for 1D dense patterns with good pitch control such as NAND Flash memory applications, but it is still challenging to apply SADP to 2D random logic patterns. The favored type of SADP for complex logic interconnects is a two mask approach using a core mask and a trim mask. In this paper, we first describe layout decomposition methods of spacer-type double patterning lithography, then report a type of SADP compliant layouts, and finally report SADP applications on Samsung 22nm SRAM layout. For SADP decomposition, we propose several SADP-aware layout coloring algorithms and a method of generating lithography-friendly core mask patterns. Experimental results on 22nm node designs show that our proposed layout decomposition for SADP effectively decomposes any given layouts.

Random matrix approach to plasmon resonances in the random impedance network model of disordered nanocomposites

NASA Astrophysics Data System (ADS)

Olekhno, N. A.; Beltukov, Y. M.

2018-05-01

Random impedance networks are widely used as a model to describe plasmon resonances in disordered metal-dielectric and other two-component nanocomposites. In the present work, the spectral properties of resonances in random networks are studied within the framework of the random matrix theory. We have shown that the appropriate ensemble of random matrices for the considered problem is the Jacobi ensemble (the MANOVA ensemble). The obtained analytical expressions for the density of states in such resonant networks show a good agreement with the results of numerical simulations in a wide range of metal filling fractions 0

Implementing a knowledge translation intervention in long-term care: feasibility results from the Vitamin D and Osteoporosis Study (ViDOS).

PubMed

Kennedy, Courtney C; Thabane, Lehana; Ioannidis, George; Adachi, Jonathan D; Papaioannou, Alexandra

2014-12-01

To evaluate the feasibility of implementing an interdisciplinary, multifaceted knowledge translation intervention within long-term care (LTC) and to identify any challenges that should be considered in designing future studies. Cluster randomized controlled trial. Forty LTC homes across the province of Ontario, Canada. LTC teams composed of physicians, nurses, pharmacists, and other staff. Cluster-level feasibility measures, including recruitment, retention, data completion, and participation in the intervention. A process evaluation was completed by directors of care indicating which process/policy changes had been implemented. Recruitment and retention rates were 22% and 63%, respectively. Good fidelity with the intervention was achieved, including attendance at educational meetings. After ViDOS, 7 process indicators were being newly implemented by more than 50% of active intervention homes. Despite recruitment and retention challenges, the multifaceted intervention produced a number of policy/process changes and had good intervention fidelity. This study is registered at ClinicalTrials.gov NCT01398527. Copyright © 2014. Published by Elsevier Inc.

Efficacy and durability of hyaluronic acid fillers for malar enhancement: A prospective, randomized, split-face clinical controlled trial.

PubMed

Jeong, Ki Heon; Gwak, Min Jae; Moon, Sung Kyung; Lee, Sang Jun; Shin, Min Kyung

2018-06-01

Various hyaluronic acid fillers can be used for facial attenuation and rejuvenation. The efficacy and durability of hyaluronic acid fillers are of major concern to dermatologists and patients. This study aimed to evaluate three-dimensional morphology, tissue distribution, and changes in volume after injection of two different hyaluronic acid fillers. Ten Korean women were enrolled in this study. Each subject was injected with monophasic hyaluronic acid filler in one malar area and biphasic filler in the other. Clinical outcome was measured before and after injection, and after 2, 4, 6, 8, 12, and 24 weeks, using the Global Aesthetic Improvement Scale, photographs and Moire's topography. Facial magnetic resonance imaging (MRI) was performed twice over six months. Both products showed good results after injection and demonstrated good durability over time. MRI was a useful modality for assessing tissue distribution and volume changes. The effects and durability after injection of monophasic hyaluronic acid filler and biphasic hyaluronic acid filler are generally comparable.

Competition of individual and institutional punishments in spatial public goods games

NASA Astrophysics Data System (ADS)

Szolnoki, Attila; Szabó, György; Czakó, Lilla

2011-10-01

We have studied the evolution of strategies in spatial public goods games where both individual (peer) and institutional (pool) punishments are present in addition to unconditional defector and cooperator strategies. The evolution of strategy distribution is governed by imitation based on the random sequential comparison of neighbors’ payoff for a fixed level of noise. Using numerical simulations, we evaluate the strategy frequencies and phase diagrams when varying the synergy factor, punishment cost, and fine. Our attention is focused on two extreme cases describing all the relevant behaviors in such a complex system. According to our numerical data peer punishers prevail and control the system behavior in a large segments of parameters while pool punishers can only survive in the limit of weak peer punishment when a rich variety of solutions is observed. Paradoxically, the two types of punishment may extinguish each other’s impact, resulting in the triumph of defectors. The technical difficulties and suggested methods are briefly discussed.

Addressing the controversy of rate-versus-rhythm control in atrial fibrillation.

PubMed

Contractor, Tahmeed; Levin, Vadim; Desai, Ravi; Marchlinski, Francis E

2013-09-01

Atrial fibrillation is the most common sustained cardiac arrhythmia and significantly increases patient risk of stroke, cardiomyopathy, and mortality. Rate versus rhythm control as the "best" treatment strategy remains an issue of considerable, ongoing debate. A multitude of clinical trials have compared the 2 strategies and have not shown any benefit of one approach over the other. However, the trials were conducted in specific subgroups of patients and demonstrated low success rates with antiarrhythmic drug (AAD) therapy and a high incidence of adverse AAD effects. Sub-analyses of the trials have confirmed that successful rhythm control with sinus rhythm restoration is associated with a significant reduction in patient mortality. More recently, radiofrequency ablation (RFA) has emerged as a relatively effective procedure for maintaining sinus rhythm compared with use of AADs. Prospective randomized studies have shown good treatment results after the use of RFA, with acceptable risk. Given the limitation of pharmacologic rate versus rhythm control studies, and the promise of RFA, rhythm control should again be reconsidered as the "best" approach for managing many subgroups of patients with atrial fibrillation.

AIDE-Acute Illness and Depression in Elderly Patients. Cognitive Behavioral Group Psychotherapy in Geriatric Patients With Comorbid Depression: A Randomized, Controlled Trial.

PubMed

Hummel, Jana; Weisbrod, Cecilia; Boesch, Leila; Himpler, Katharina; Hauer, Klaus; Hautzinger, Martin; Gaebel, Andrea; Zieschang, Tania; Fickelscherer, Andrea; Diener, Slawomira; Dutzi, Ilona; Krumm, Bertram; Oster, Peter; Kopf, Daniel

2017-04-01

Comorbid depression is highly prevalent in geriatric patients and associated with functional loss, frequent hospital re-admissions, and a higher mortality rate. Cognitive behavioral psychotherapy (CBT) has shown to be effective in older depressive patients living in the community. To date, CBT has not been applied to older patients with acute physical illness and comorbid depression. To evaluate the effectiveness of CBT in depressed geriatric patients, hospitalized for acute somatic illness. Randomized controlled trial with waiting list control group. Postdischarge intervention in a geriatric day clinic; follow-up evaluations at the patients' homes. A total of 155 randomized patients, hospitalized for acute somatic illness, aged 82 ± 6 years and suffering from depression [Hospital Anxiety and Depression Scale (HADS) scores >7]. Exclusion criteria were dementia, delirium, and terminal state of medical illness. Fifteen, weekly group sessions based on a CBT manual. Commencement of psychotherapy immediately after discharge in the intervention group and a 4-month waiting list interval with usual care in the control group. HADS depression total score after 4 months. Secondary endpoints were functional, cognitive, psychosocial and physical status, resource utilization, caregiver burden, and amount of contact with physician. The intervention group improved significantly in depression scores (HADS baseline 18.8; after 4 months 11.4), whereas the control group deteriorated (HADS baseline 18.1; after 4 months 21.6). Significant improvement in the intervention group, but not in the control group, was observed for most secondary outcome parameters such as the Barthel and Karnofsky indexes. Intervention effects were less pronounced in patients with cognitive impairment or acute fractures. CBT is feasible and highly effective in geriatric patients. The benefits extend beyond effective recovery and include improvement in physical and functional parameters. Early diagnosis, good access to psychotherapy, and early intervention could improve care for depressive older patients. www.germanctr.de German Trial Register DRKS 00004728. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Short-term effectiveness of web-based guided self-help for phobic outpatients: randomized controlled trial.

PubMed

Kok, Robin N; van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

2014-09-29

Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice. Netherlands Trial Register NTR2233; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2233 (Archived by WebCite at http://www.webcitation.org/6O2ioOQSs).

Effectiveness of Plaque Control with Novel Pediatric Oral Hygiene Need Station (Modified Oral Irrigation Device) as Compared with Manual Brushing and Flossing: Randomized Controlled Pilot Trial

PubMed Central

Murthy, Prashanth Sadashiva; Shaik, Naseemoon; Deshmukh, Seema; Girish, M. S.

2018-01-01

Background: Establishing good hygiene habits are valuable for present and future oral health. Below 6 years, tooth brushing should be performed by parents, as increasing dexterity and cognition may permit supervised brushing until the child is capable of independent brushing. Aim and Objectives: The aim of the present study was to evaluate the effectiveness of modified oral irrigation device in children in terms of plaque control and to compare the effectiveness of plaque control with manual brushing with the modified oral irrigation device in children. Materials and Methods: A randomized clinical trial was performed on 12 subjects who were allocated to the two study groups. After obtaining the consent, the control group was instructed tooth brushing with regular pediatric commercially available toothbrush and the intervention group with modified oral irrigation device. Plaque scores in both groups were assessed pre- and post-brushing using modified navy plaque index. Results: The data were subjected to Descriptive statistics and Paired t-test using SPSS version 22. Intragroup comparison of mean difference of plaque score in control group and intervention group pre- and post-brushing was statistically significant. Intergroup comparison of manual brushing group with modified oral irrigation group shows P < 0.05 was statistically significant. Conclusion: Within the limitation of the present study, it has been found novel pediatric oral hygiene need Station is more effective than manual brushing since it combined the effect of brushing, flossing (water floss), and rinsing in children simultaneously and at the same time did not demand any special motor skill. PMID:29875555

The Fallacy of Average: How Using HbA1c Alone to Assess Glycemic Control Can Be Misleading.

PubMed

Beck, Roy W; Connor, Crystal G; Mullen, Deborah M; Wesley, David M; Bergenstal, Richard M

2017-08-01

HbA 1c is a v aluable metric for comparing treatment groups in a randomized trial, for assessing glycemic trends in a population over time, or for cross-sectional comparisons of glycemic control in different populations. However, what is not widely appreciated is that HbA 1c may not be a good indicator of an individual patient's glycemic control because of the wide range of mean glucose concentrations and glucose profiles that can be associated with a given HbA 1c level. To illustrate this point, we plotted mean glucose measured with continuous glucose monitoring (CGM) versus central laboratory-measured HbA 1c in 387 participants in three randomized trials, showing that not infrequently HbA 1c may underestimate or overestimate mean glucose, sometimes substantially. Thus, if HbA 1c is to be used to assess glycemic control, it is imperative to know the patient's actual mean glucose to understand how well HbA 1c is an indicator of the patient's glycemic control. With knowledge of the mean glucose, an estimated HbA 1c (eA1C) can be calculated with the formula provided in this article to compare with the measured HbA 1c . Estimating glycemic control from HbA 1c alone is in essence applying a population average to an individual, which can be misleading. Thus, a patient's CGM glucose profile has considerable value for optimizing his or her diabetes management. In this era of personalized, precision medicine, there are few better examples with respect to the fallacy of applying a population average to a specific patient rather than using specific information about the patient to determine the optimal approach to treatment. © 2017 by the American Diabetes Association.

Ethical acceptability of offering financial incentives for taking antipsychotic depot medication: patients' and clinicians' perspectives after a 12-month randomized controlled trial.

PubMed

Noordraven, Ernst L; Schermer, Maartje H N; Blanken, Peter; Mulder, Cornelis L; Wierdsma, André I

2017-08-29

A randomized controlled trial 'Money for Medication'(M4M) was conducted in which patients were offered financial incentives for taking antipsychotic depot medication. This study assessed the attitudes and ethical considerations of patients and clinicians who participated in this trial. Three mental healthcare institutions in secondary psychiatric care in the Netherlands participated in this study. Patients (n = 169), 18-65 years, diagnosed with schizophrenia, schizoaffective disorder or another psychotic disorder who had been prescribed antipsychotic depot medication, were randomly assigned to receive 12 months of either treatment as usual plus a financial reward for each depot of medication received (intervention group) or treatment as usual alone (control group). Structured questionnaires were administered after the 12-month intervention period. Data were available for 133 patients (69 control and 64 intervention) and for 97 clinicians. Patients (88%) and clinicians (81%) indicated that financial incentives were a good approach to improve medication adherence. Ethical concerns were categorized according to the four-principles approach (autonomy, beneficence, non-maleficence, and justice). Patients and clinicians alike mentioned various advantages of M4M in clinical practice, such as increased medication adherence and improved illness insight; but also disadvantages such as reduced intrinsic motivation, loss of autonomy and feelings of dependence. Overall, patients evaluated financial incentives as an effective method of improving medication adherence and were willing to accept this reward during clinical treatment. Clinicians were also positive about the use of this intervention in daily practice. Ethical concerns are discussed in terms of patient autonomy, beneficence, non-maleficence and justice. We conclude that this intervention is ethically acceptable under certain conditions, and that further research is necessary to clarify issues of benefit, motivation and the preferred size and duration of the incentive. Nederlands Trial Register, number NTR2350 .

Emotional Intelligence and Life Adjustment for Nigerian Secondary Students

ERIC Educational Resources Information Center

Ogoemeka, Obioma Helen

2013-01-01

In the process of educating adolescents, good emotional development and life adjustment are two significant factors for teachers to know. This study employed random cluster sampling of senior secondary school students in Ondo and Oyo States in south-western Nigeria. The Random sampling was employed to select 1,070 students. The data collected were…

Dispensing good sleep health behaviours not pills--a cluster-randomized controlled trial to test the feasibility and efficacy of pharmacist-provided brief behavioural treatment for insomnia.

PubMed

Fuller, Joanne M; Wong, Keith K; Hoyos, Camilla; Krass, Ines; Saini, Bandana

2016-02-01

Behavioural therapies are recommended as the first-line treatment of insomnia; however, sedatives and hypnotics constitute the main treatment modality used in primary care. Community pharmacies provide a unique conduit for identifying and providing appropriate treatment for those with insomnia either purchasing prescription sedatives or seeking over-the-counter treatments. A feasibility study using a cluster-randomized controlled trial, testing the efficacy of trained pharmacists providing behavioural interventions such as stimulus control and sleep restriction to patients with insomnia, in improving insomnia severity was conducted. The intervention involved three pharmacy visits (baseline, 1 and 3 months follow-up). The control group received usual care and information sheets on insomnia. The primary outcome was the Insomnia Severity Index. Twelve community pharmacists (five control, seven intervention) in New South Wales, Australia were recruited and trained. These pharmacists, in turn, recruited 46 patients (22 control, 24 intervention (mean age 53.7 ± 18.4, 72% females) and delivered a brief behavioural therapy intervention. The overall decrease in Insomnia Severity Index from baseline to the 3-month follow-up in the intervention group, n = 17 (7.6 ± 4.3 points), was significantly greater than for the control group, n = 19 (2.9 ± 8.8 points) (mean difference 4.6, 95% confidence interval: 0.005-9.2, P = 0.05). However, when the effect of clustering was taken into account using a mixed-effects model, the estimated difference in Insomnia Severity Index (change from baseline to visit 3) between the intervention and control groups was not significant (group difference in Insomnia Severity Index change = 3.78, 95% confidence interval: -0.81 to 8.37, P = 0.11; intracluster correlation = 0.18). The study highlights the use of a novel venue to deliver brief behavioural therapies for insomnia using trained non-psychologist health professionals. Although, when cluster effect was taken into account, the difference in Insomnia Severity Index reduction between the intervention versus control groups was non-significant, the results highlight that reductions in insomnia severity can be gained using trained pharmacists providing brief behavioural interventions. Future research in this area is warranted, with appropriately sized studies using the conventional, robust randomized trial design. © 2015 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.

31 CFR 560.306 - Iranian-origin goods or services; goods or services owned or controlled by the Government of Iran.

Code of Federal Regulations, 2012 CFR

2012-07-01

...; goods or services owned or controlled by the Government of Iran. 560.306 Section 560.306 Money and... goods or services; goods or services owned or controlled by the Government of Iran. (a) The terms goods..., extracted, or processed in Iran; and (2) Goods which have entered into Iranian commerce. (b) The terms...

31 CFR 560.306 - Iranian-origin goods or services; goods or services owned or controlled by the Government of Iran.

Code of Federal Regulations, 2011 CFR

2011-07-01

...; goods or services owned or controlled by the Government of Iran. 560.306 Section 560.306 Money and... goods or services; goods or services owned or controlled by the Government of Iran. (a) The terms goods..., extracted, or processed in Iran; and (2) Goods which have entered into Iranian commerce. (b) The terms...

31 CFR 560.306 - Iranian-origin goods or services; goods or services owned or controlled by the Government of Iran.

Code of Federal Regulations, 2010 CFR

2010-07-01

...; goods or services owned or controlled by the Government of Iran. 560.306 Section 560.306 Money and... goods or services; goods or services owned or controlled by the Government of Iran. (a) The terms goods..., extracted, or processed in Iran; and (2) Goods which have entered into Iranian commerce. (b) The terms...

Mechanical properties of electrospun bilayer fibrous membranes as potential scaffolds for tissue engineering.

PubMed

Pu, Juan; Komvopoulos, Kyriakos

2014-06-01

Bilayer fibrous membranes of poly(l-lactic acid) (PLLA) were fabricated by electrospinning, using a parallel-disk mandrel configuration that resulted in the sequential deposition of a layer with fibers aligned across the two parallel disks and a layer with randomly oriented fibers, both layers deposited in a single process step. Membrane structure and fiber alignment were characterized by scanning electron microscopy and two-dimensional fast Fourier transform. Because of the intricacies of the generated electric field, bilayer membranes exhibited higher porosity than single-layer membranes consisting of randomly oriented fibers fabricated with a solid-drum collector. However, despite their higher porosity, bilayer membranes demonstrated generally higher elastic modulus, yield strength and toughness than single-layer membranes with random fibers. Bilayer membrane deformation at relatively high strain rates comprised multiple abrupt microfracture events characterized by discontinuous fiber breakage. Bilayer membrane elongation yielded excessive necking of the layer with random fibers and remarkable fiber stretching (on the order of 400%) in the layer with fibers aligned in the stress direction. In addition, fibers in both layers exhibited multiple localized necking, attributed to the nonuniform distribution of crystalline phases in the fibrillar structure. The high membrane porosity, good mechanical properties, and good biocompatibility and biodegradability of PLLA (demonstrated in previous studies) make the present bilayer membranes good scaffold candidates for a wide range of tissue engineering applications. Copyright © 2014 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!).

PubMed

Coffey, Frank; Dissmann, Patrick; Mirza, Kazim; Lomax, Mark

2016-11-01

Acute pain remains highly prevalent in the Emergency Department (ED) setting. This double-blind, randomized, placebo-controlled UK study investigated the efficacy and safety of low-dose methoxyflurane analgesia for the treatment of acute pain in the ED in the adult population of the STOP! trial. Patients presenting to the ED requiring analgesia for acute pain (pain score of 4-7 on the Numerical Rating Scale) due to minor trauma were randomized in a 1:1 ratio to receive methoxyflurane (up to 6 mL) or placebo (normal saline), both via a Penthrox ® (Medical Developments International Limited, Scoresby, Australia) inhaler. Rescue medication (paracetamol/opioids) was available immediately upon request. Change from baseline in visual analog scale (VAS) pain intensity was the primary endpoint. 300 adult and adolescent patients were randomized; data are presented for the adult subgroup (N = 204). Mean baseline VAS pain score was ~66 mm in both groups. The mean change from baseline to 5, 10, 15 and 20 min was greater for methoxyflurane (-20.7, -27.4, -33.3 and -34.8 mm, respectively) than placebo (-8.0, -11.1, -12.3 and -15.2 mm, respectively). The primary analysis showed a highly significant treatment effect overall across all four time points (-17.4 mm; 95% confidence interval: -22.3 to -12.5 mm; p < 0.0001). Median time to first pain relief was 5 min with methoxyflurane [versus 20 min with placebo; (hazard ratio: 2.32; 95% CI: 1.63, 3.30; p < 0.0001)]; 79.4% of methoxyflurane-treated patients experienced pain relief within 1-10 inhalations. 22.8% of placebo-treated patients requested rescue medication within 20 min compared with 2.0% of methoxyflurane-treated patients (p = 0.0003). Methoxyflurane treatment was rated 'Excellent', 'Very Good' or 'Good' by 77.6% of patients, 74.5% of physicians and 72.5% of nurses. Treatment-related adverse events (mostly dizziness/headache) were reported by 42.2% of patients receiving methoxyflurane and 14.9% of patients receiving placebo; none caused withdrawal and the majority were mild and transient. The results of this study support the evidence from previous trials that low-dose methoxyflurane administered via the Penthrox inhaler is a well-tolerated, efficacious and rapid-acting analgesic. Medical Developments International (MDI) Limited and Mundipharma Research GmbH & Co.KG. Clinicaltrials.gov identifier: NCT01420159, EudraCT number: 2011-000338-12.

Effects of interventions on trajectories of health-related quality of life among older patients with hip fracture: a prospective randomized controlled trial.

PubMed

Tseng, Ming-Yueh; Liang, Jersey; Shyu, Yea-Ing L; Wu, Chi-Chuan; Cheng, Huey-Shinn; Chen, Ching-Yen; Yang, Shu-Fang

2016-03-03

Health-related quality of life (HRQoL) has been used to assess subjects' prognosis and recovery following hip fracture. However, evidence is mixed regarding the effectiveness of interventions to improve HRQoL of elders with hip fracture. The purposes of this study were to identify distinct HRQoL trajectories and to evaluate the effects of two care models on these trajectories over 12 months following hip-fracture surgery. For this secondary analysis, data came from a randomized controlled trial of subjects with hip fracture receiving three treatment care models: interdisciplinary care (n = 97), comprehensive care (n = 91), and usual care (n = 93). Interdisciplinary care consisted of geriatric consultation, discharge planning, and 4 months of in-home rehabilitation. Comprehensive care consisted of interdisciplinary care plus management of malnutrition and depressive symptoms, fall prevention, and 12 months of in-home rehabilitation. Usual care included only in-hospital rehabilitation and occasional discharge planning, without geriatric consultation and in-home rehabilitation. Mental and physical HRQoL were measured at 1, 3, 6, and 12 months after discharge by the physical component summary scale (PCS) and mental component summary scale (MCS), respectively, of the Medical Outcomes Study Short Form 36, Taiwan version. Latent class growth modeling was used to identify PCS and MCS trajectories and to evaluate how they were affected by the interdisciplinary and comprehensive care models. We identified three quadratic PCS trajectories: poor PCS (n = 103, 36.6 %), moderate PCS (n = 96, 34.2 %), and good PCS (n = 82, 29.2 %). In contrast, we found three linear MCS trajectories: poor MCS (n = 39, 13.9 %), moderate MCS (n = 84, 29.9 %), and good MCS (n = 158, 56.2 %). Subjects in the comprehensive care and interdisciplinary care groups were more likely to experience a good PCS trajectory (b = 0.99, odds ratio [OR] = 2.69, confidence interval [CI] = 7.24-1.00, p = 0.049, and b = 1.32, OR = 3.75, CI = 10.53-1.33, p = 0.012, respectively) than those who received usual care. However, neither care model improved MCS. The interdisciplinary and comprehensive care models improved recovery from hip fracture by increasing subjects' odds for following a trajectory of good physical functioning after hospitalization. ClinicalTrials.gov ( NCT01350557 ).

Is It Necessary to Repair Stable Ramp Lesions of the Medial Meniscus During Anterior Cruciate Ligament Reconstruction? A Prospective Randomized Controlled Trial.

PubMed

Liu, Xin; Zhang, Hui; Feng, Hua; Hong, Lei; Wang, Xue-Song; Song, Guan-Yang

2017-04-01

A special type of meniscal lesion involving the peripheral attachment of the posterior horn of the medial meniscus (PHMM), termed a "ramp lesion," is commonly associated with an anterior cruciate ligament (ACL) injury. However, its treatment is still controversial. Recently, stable ramp lesions treated with abrasion and trephination alone have been shown to have good clinical outcomes after ACL reconstruction. Stable ramp lesions treated with abrasion and trephination alone during ACL reconstruction will result in similar clinical outcomes compared with those treated with surgical repair. Randomized controlled trial; Level of evidence, 2. A prospective randomized controlled study was performed in 91 consecutive patients who had complete ACL injuries and concomitant stable ramp lesions of the medial meniscus. All patients were randomly allocated to 1 of 2 groups based on whether the stable ramp lesions were surgically repaired (study group; n = 50) or only abraded and trephined (control group; n = 41) during ACL reconstruction. All surgical procedures were performed by a single surgeon who was blinded to the functional assessment findings of the patients. The Lysholm score, subjective International Knee Documentation Committee (IKDC) score, and stability assessments (pivot-shift test, Lachman test, KT-1000 arthrometer side-to-side difference, and KT-1000 arthrometer differences of <3, 3-5, and >5 mm) were evaluated preoperatively and at the last follow-up. Moreover, magnetic resonance imaging (MRI) was used to evaluate the healing status of the ramp lesions. All consecutive patients who were screened for eligibility from August 2008 to April 2012 were enrolled and observed clinically. There were 40 patients in the study group and 33 patients in the control group who were observed for at least 2 years. At the final follow-up, there were no significant differences between the study group and the control group in terms of the mean Lysholm score (88.7 ± 4.8 vs 90.4 ± 5.8, respectively; P = .528), mean subjective IKDC score (83.6 ± 3.7 vs 82.2 ± 4.5, respectively; P = .594), pivot-shift test results ( P = .658), Lachman test results ( P = .525), KT-1000 arthrometer side-to-side difference (1.6 ± 1.2 vs 1.5 ± 1.1, respectively; P = .853), or KT-1000 arthrometer grading ( P = .738). Overall, for both groups (n = 73), 67 patients showed completely healed (38 study, 29 control), 3 showed partially healed (1 study, 2 control), and 3 showed nonhealed (1 study, 2 control) signals on follow-up MRI when evaluating the healing status of the ramp lesions. There was no significant difference regarding the healing status of the ramp lesions between the 2 groups ( P = .543). This prospective randomized controlled trial showed that, in terms of subjective scores, knee stability, and meniscal healing status, concomitant stable ramp lesions of the medial meniscus treated with abrasion and trephination alone during ACL reconstruction resulted in similar clinical outcomes compared with those treated with surgical repair.

Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis.

PubMed

Peyro Saint Paul, Laure; Debruyne, Danièle; Bernard, Delphine; Mock, Donald M; Defer, Gilles L

2016-01-01

Multiple sclerosis (MS) is a chronic, potentially highly disabling neurological disorder. No disease-modifying treatments are approved in the progressive and not active forms of the disease. High doses of biotin were tested in an open-label pilot study involving 23 patients with progressive MS and reported positive results. A randomized, double-blind, placebo-controlled trial in 154 progressive MS patients confirmed the beneficial effect of MD1003 (high-dose biotin) on reversing or stabilizing disability progression, with a good safety profile. It is proposed that MD1003 in progressive MS 1) increases energy production in demyelinated axons and/or 2) enhances myelin synthesis in oligodendrocytes. Biotin is highly bioavailable; absorption and excretion are rapid. The major route of elimination is urinary excretion. A high oral dose of biotin seems generally well tolerated but a few important safety concerns were identified: 1) teratogenicity in one species and 2) interference with some biotin-based laboratory immunoassays. The animal toxicity data are limited at such high doses. Further preclinical studies would be useful to address the mechanism of action of MD1003. Assessment of clinical benefit duration in responders will be also very important to set. Results of randomized, placebo-controlled trial are reassuring and provide hope for the treatment of progressive MS.

Optimizing lay counsellor services for chronic care in South Africa: a qualitative systematic review.

PubMed

Petersen, Inge; Fairall, Lara; Egbe, Catherine O; Bhana, Arvin

2014-05-01

To conduct a qualitative systematic review on the use of lay counsellors in South Africa to provide lessons on optimizing their use for psychological and behavioural change counselling for chronic long-term care in scare-resource contexts. A qualitative systematic review of the literature on lay counsellor services in South Africa. Twenty-nine studies met the inclusion criteria. Five randomized control trials and two cohort studies reported that lay counsellors can provide behaviour change counselling with good outcomes. One multi-centre cohort study provided promising evidence of improved anti-retroviral treatment adherence and one non-randomized controlled study provided promising results for counselling for depression. Six studies found low fidelity of lay counsellor-delivered interventions in routine care. Reasons for low fidelity include poor role definition, inconsistent remuneration, lack of standardized training, and poor supervision and logistical support. Within resource-constrained settings, adjunct behaviour change and psychological services provided by lay counsellors can be harnessed to promote chronic care at primary health care level. Optimizing lay counsellor services requires interventions at an organizational level that provide a clear role definition and scope of practice; in-service training and formal supervision; and sensitization of health managers to the importance and logistical requirements of counselling. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa.

PubMed

Bågesund, Mats; Tabrizi, Parisa

2008-11-01

Topical anaesthetics are important to provide pain control at dental injection. The aim was to evaluate the effectiveness of the intraoral topical anaesthetics lidocaine 20% patch (DentiPatch) and lidocaine 5% gel. The randomized unblinded cross-over study included 31 patients (ten boys, 21 girls) aged 13.5 +/- 2.5 years. Application of lidocaine patch or gel was randomly used at first and second visit in the upper premolar region. Heart rate was measured before and at each needle insertion after 2.5, 5, and 15 min and at injection after 15 min. Discomfort and pain were expressed in visual analogue scales (VAS). Paired t-test and Mann-Whitney U-test were used for statistic analyses. Heart rate at buccal injection decreased more when the patch was used (P = 0.0149). Heart rate was lower at the second visit (P = 0.0287). Patients expressed less discomfort when the patch was used on both buccal (P = 0.0150) and palatal (P = 0.0391) site. Boys had lower heart rate and VAS pain scale ratings than girls. Good pain control can reduce the patients' anxiety level--expressed in heart rate--at the second appointment. The patch and gel seem to provide similar pain reduction at needle stick and injection of local anaesthetics.

The Effect of Different Exercise Programs on Size and Function of Deep Cervical Flexor Muscles in Patients With Chronic Nonspecific Neck Pain: A Systematic Review of Randomized Controlled Trials.

PubMed

Amiri Arimi, Somayeh; Mohseni Bandpei, Mohammad Ali; Javanshir, Khodabakhsh; Rezasoltani, Asghar; Biglarian, Akbar

2017-08-01

Neck pain is one of the major public health problems, which has a great impact on people's lives. The purpose of this study was to systematically review published studies conducted on the effect of different exercise programs on activity, size, endurance, and strength of deep cervical flexor (DCF) muscles in patients with chronic neck pain. The PubMed, Science Direct, OVID, Google scholar, Cochrane Library, and Physiotherapy Evidence Databases were searched to determine relevant articles published from 1990 to March 2016. The articles were qualitatively assessed based on the Physiotherapy Evidence Databases scale for randomized controlled trials studies. Nine articles were identified and evaluated in the final analysis. Four studies had moderate quality, and five studies had good quality. From those nine studies, eight studies gave support to the effectiveness of specific low-load exercise training on DCF muscles parameters, while one study reported no significant difference between this exercise and other cervical exercise programs. The results of reviewed studies are in favor of specific low-load craniocervical flexion exercise, which seems to be a highly effective exercise regimen compared to other types of exercises in improving DCF muscles impairments in patients with chronic neck pain.

The lipid-lowering effects of 4 weeks of daily soymilk or dairy milk ingestion in a postmenopausal female population.

PubMed

Beavers, Kristen M; Serra, Monica C; Beavers, Daniel P; Hudson, Geoffrey M; Willoughby, Darryn S

2010-06-01

Alterations in plasma cholesterol concentrations, especially increases in low-density lipoprotein (LDL), are well-known risk factors in the development of atherosclerosis. Numerous studies have examined the lipid-lowering effects of functional soy-containing foods, but few have specifically examined soymilk, with equivocal findings reported. In September 2008, a single-blind, randomized, controlled trial was conducted on 32 postmenopausal women at Baylor University, Waco, TX, USA. After a 2-week run-in period, subjects were randomly assigned to consume three servings of vanilla soy (n = 16) or reduced-fat dairy (n = 16) milk per day for 4 weeks. Plasma lipid profiles were obtained pre- and post-supplementation. Plasma high-density lipoprotein, LDL, and triglycerides were not significantly different between groups post-intervention (P = .45) or from baseline (P = .83). Separate analysis of plasma total cholesterol levels yielded similar results (P = .19 and P = .92, respectively). Furthermore, subanalyses controlling for dyslipidemia (n = 23) and lipid-lowering medication usage (n = 28) did not significantly alter results. Despite good dietary compliance, our study failed to show a significant hypocholesterolemic effect of soymilk consumption in this postmenopausal female population. Potential reasons for this nonsignificant finding are discussed, and future research directions are presented.

[Phosphodiesterase inhibitors in clinical practice. The present and the future. Part II].

PubMed

Baksheev, B I; Kolomiets, N M

2007-01-01

Type Sphosphodiesterase inhibitors (FDEI-5) used to be applied as the main drugs for treatment of erectile dysfunction. At present, this pharmacological group is being studied intensively in various fields of clinical medicine, such as pulmonology, cardiology, gastroenterology, gynecology etc. Part II of this system literature review is dedicated to analysis of the results of such application. In many randomized and non-randomized controlled studies sildenafil decreased pulmonary arterial pressure (independently of etiology) and pulmonary vascular resistance; it could be successfully combined with nitric oxide, illoprost, or epoprostenolol. Clinical studies have also demonstrated an increase in physical load tolerance, optimization of PAH studies according to NYHA functional classes, and good tolerance to the drug. In the recent years, antiischaemic effects of FDEI-5 and their ability to inhibit apoptosis have been proved It is possible to draw the conclusion that nature created a universal phosphodiesterase mechanism for the interconnection of biochemical processes that provide the vital activity of the cell and organism. The fact that more than 15 controlled studies of clinical application of sildenafil not for treatment of erectile dysfunction have been planned and commenced confirms the importance of further studies of this mechanism. Further analysis of the results will show how universal this mechanism is.

Integrating Epitaxial-Like Pb(Zr,Ti)O3 Thin-Film into Silicon for Next-Generation Ferroelectric Field-Effect Transistor

PubMed Central

Park, Jae Hyo; Kim, Hyung Yoon; Jang, Gil Su; Seok, Ki Hwan; Chae, Hee Jae; Lee, Sol Kyu; Kiaee, Zohreh; Joo, Seung Ki

2016-01-01

The development of ferroelectric random-access memory (FeRAM) technology with control of grain boundaries would result in a breakthrough for new nonvolatile memory devices. The excellent piezoelectric and electrical properties of bulk ferroelectrics are degraded when the ferroelectric is processed into thin films because the grain boundaries then form randomly. Controlling the nature of nucleation and growth are the keys to achieving a good crystalline thin-film. However, the sought after high-quality ferroelectric thin-film has so far been thought to be impossible to make, and research has been restricted to atomic-layer deposition which is extremely expensive and has poor reproducibility. Here we demonstrate a novel epitaxial-like growth technique to achieve extremely uniform and large rectangular-shaped grains in thin-film ferroelectrics by dividing the nucleation and growth phases. With this technique, it is possible to achieve 100-μm large uniform grains, even made available on Si, which is large enough to fabricate a field-effect transistor in each grain. The electrical and reliability test results, including endurance and retention test results, were superior to other FeRAMs reported so far and thus the results presented here constitute the first step toward the development of FeRAM using epitaxial-like ferroelectric thin-films. PMID:27005886

Timing of cord clamping in very preterm infants: more evidence is needed.

PubMed

Tarnow-Mordi, William O; Duley, Lelia; Field, David; Marlow, Neil; Morris, Jonathan; Newnham, John; Paneth, Nigel; Soll, Roger F; Sweet, David

2014-08-01

In December 2012, the American College of Obstetricians and Gynecologists published a Committee Opinion entitled "Timing of umbilical cord clamping after birth." It stated that "evidence exists to support delayed cord clamping in preterm infants, when feasible. The single most important benefit for preterm infants is the possibility for a nearly 50% reduction in IVH." However, the Committee Opinion added that the ideal timing of umbilical cord clamping has yet to be determined and recommended that large clinical trials be conducted in the most preterm infants. Published randomized controlled trials include <200 infants of <30 weeks' gestation, with assessments of neurodevelopmental outcome in less than one-half of the children. This is a major gap in the evidence. Without reliable data from randomized controlled trials that optimally include childhood follow-up evaluations, we will not know whether delayed cord clamping may do more overall harm than good. Ongoing trials of delayed cord clamping plan to report childhood outcomes in >2000 additional very preterm infants. Current recommendations may need to change when these results become available. Greater international collaboration could accelerate resolution of whether this promising intervention will improve disability-free survival in about 1 million infants who will be born very preterm globally each year. Copyright © 2014 Mosby, Inc. All rights reserved.

Coffee, caffeine, and sleep: A systematic review of epidemiological studies and randomized controlled trials.

PubMed

Clark, Ian; Landolt, Hans Peter

2017-02-01

Caffeine is the most widely consumed psychoactive substance in the world. It is readily available in coffee and other foods and beverages, and is used to mitigate sleepiness, enhance performance, and treat apnea in premature infants. This review systematically explores evidence from epidemiological studies and randomized controlled trials as to whether coffee and caffeine have deleterious effects on sleep. Caffeine typically prolonged sleep latency, reduced total sleep time and sleep efficiency, and worsened perceived sleep quality. Slow-wave sleep and electroencephalographic (EEG) slow-wave activity were typically reduced, whereas stage-1, wakefulness, and arousals were increased. Dose- and timing-response relationships were established. The sleep of older adults may be more sensitive to caffeine compared to younger adults. Pronounced individual differences are also present in young people, and genetic studies isolated functional polymorphisms of genes implicated in adenosine neurotransmission and metabolism contributing to individual sensitivity to sleep disruption by caffeine. Most studies were conducted in male adults of Western countries, which limits the generalizability of the findings. Given the importance of good sleep for general health and functioning, longitudinal investigations aimed at establishing possible causal relationships among coffee- and caffeine-induced changes in sleep quality and health development are warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 2.

PubMed

Hoaglin, David C; Hawkins, Neil; Jansen, Jeroen P; Scott, David A; Itzler, Robbin; Cappelleri, Joseph C; Boersma, Cornelis; Thompson, David; Larholt, Kay M; Diaz, Mireya; Barrett, Annabel

2011-06-01

Evidence-based health care decision making requires comparison of all relevant competing interventions. In the absence of randomized controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best treatment(s). Mixed treatment comparisons, a special case of network meta-analysis, combine direct evidence and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than traditional meta-analysis. This report from the International Society for Pharmacoeconomics and Outcomes Research Indirect Treatment Comparisons Good Research Practices Task Force provides guidance on technical aspects of conducting network meta-analyses (our use of this term includes most methods that involve meta-analysis in the context of a network of evidence). We start with a discussion of strategies for developing networks of evidence. Next we briefly review assumptions of network meta-analysis. Then we focus on the statistical analysis of the data: objectives, models (fixed-effects and random-effects), frequentist versus Bayesian approaches, and model validation. A checklist highlights key components of network meta-analysis, and substantial examples illustrate indirect treatment comparisons (both frequentist and Bayesian approaches) and network meta-analysis. A further section discusses eight key areas for future research. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Comparison effect of physiotherapy with surgery on sexual function in patients with pelvic floor disorder: A randomized clinical trial

PubMed Central

Eftekhar, Tahereh; Sohrabi, Maryam; Haghollahi, Fedyeh; Shariat, Mamak; Miri, Elahe

2014-01-01

Background: Female sexual dysfunction is a common problem among general population, especially in urogynecological patient, and can lead to a decrease in quality of life and affect martial relationship. Objective: This study was compared the effect of surgical methods versus physiotherapy on sexual function in pelvic floor disorder. Materials and Methods: This randomized controlled trial was performed in Urogynecology clinic since August 2007 to December 2009 on 90 patients aged from 25-55 years with previous delivery, positive history of sexual dysfunction with stage <3 of pelvic organ prolapsed and divided in two groups. Group A (n=45) received standard rectocele repair and prineorrhaphy, group B (n=45) received physiotherapy for eight weeks twice a week (electrical stimulation, Kegel exercises). The female sexual function index (FSFI) used to evaluate the sexual function in cases before and after intervention. Frequency of variable scores (libido, orgasm, dysparunia) included without disorder, frequently good, sometimes good, very much and extreme were compared between two groups. Results: Libido and arousal were improved in both groups (p=0.007, p=0.001 respectively). Orgasm and dyspareunia were improved in group B (p=0.001). Dysparunia was more painful in group A. There was significant difference between two groups (improvement of orgasm and dysparunia in group B) (p=0.001). Conclusion: It seems that physiotherapy is an appropriate method for treatment of sexual disorder in pelvic floor disorder. Registration ID in IRCT: IRCT2013031112790N1. PMID:24799856

A Comparative Study of Random Patterns for Digital Image Correlation

NASA Astrophysics Data System (ADS)

Stoilov, G.; Kavardzhikov, V.; Pashkouleva, D.

2012-06-01

Digital Image Correlation (DIC) is a computer based image analysis technique utilizing random patterns, which finds applications in experimental mechanics of solids and structures. In this paper a comparative study of three simulated random patterns is done. One of them is generated according to a new algorithm, introduced by the authors. A criterion for quantitative evaluation of random patterns after the calculation of their autocorrelation functions is introduced. The patterns' deformations are simulated numerically and realized experimentally. The displacements are measured by using the DIC method. Tensile tests are performed after printing the generated random patterns on surfaces of standard iron sheet specimens. It is found that the new designed random pattern keeps relatively good quality until reaching 20% deformation.

Association of Acculturation and Health Literacy with Prevalent Dysglycemia and Diabetes Control Among Latinos in the Boston Area Community Health (BACH) Survey.

PubMed

López, Lenny; Grant, Richard W; Marceau, Lisa; Piccolo, Rebecca; McKinlay, John B; Meigs, James B

2016-12-01

This study assessed the effect of acculturation on type 2 diabetes and whether health literacy may mediate this association. The Boston Area Community Health cohort is a multi-stage stratified random sample of adults from Boston including 744 Latinos. We defined dysglycemia as a HbA1c ≥5.7 %. Multivariable analyses examined the associations between acculturation and health literacy adjusting for demographic and clinical variables. Similar analyses were performed among participants with HbA1c ≥7.0 % to assess the association between acculturation and diabetes control. Among an insured primarily foreign born Spanish speaking Latino population, with a long residence period in the US and good healthcare utilization, higher levels of acculturation were not associated with dysglycemia. Lower levels of acculturation were associated with worse diabetes control. Health literacy level did not modify these associations. Elucidating the components of heterogeneity among Latinos will be essential for understanding the influence of acculturation on diabetes.

On the nature of the fragment environment created by the range destruction or random failure of solid rocket motor casings

NASA Technical Reports Server (NTRS)

Eck, M.; Mukunda, M.

1988-01-01

Given here are predictions of fragment velocities and azimuths resulting from the Space Transportation System Solid Rocket Motor range destruct, or random failure occurring at any time during the 120 seconds of Solid Rocket Motor burn. Results obtained using the analytical methods described showed good agreement between predictions and observations for two specific events. It was shown that these methods have good potential for use in predicting the fragmentation process of a number of generically similar casing systems. It was concluded that coupled Eulerian-Lagrangian calculational methods of the type described here provide a powerful tool for predicting Solid Rocket Motor response.

[Improving wound healing after nose surgery by combined administration of xylometazoline and dexpanthenol].

PubMed

Kehrl, W; Sonnemann, U

2000-03-01

The aim of this study was the examination of efficacy and tolerability of an application-form of the new combination of Xylometazoline with Dexpanthenol (Nasic) versus Xylometazoline alone. Randomized verum controlled parallel-group-comparison of two weeks treatment of a nasal-spray. 61 inpatients with the diagnosis Rhinitis following nasal operation were included in this study and 30 patients were treated with verum and placebo each. The assessment of nasal-breathing-resistance according to scores was defined as target-parameter. Confirmatory statistical analysis was carried out according to Wilcoxon-Mann-Whitney-U two-sided at alpha < or = 0.05. The superiority of the combination of Xylometazoline-Dexpanthenol nasal-spray versus Xylometazoline nasal spray could be proven for the target-parameter as clinically relevant and statistically significant. The clinically proven efficacy is emphasized by good tolerability of both treatments. Due to easy handling of the nasal-spray a good compliance was confirmed. Distinct improvement of symptoms in patients following nasal operations underlines the efficacy of both medications. With respect to the tolerability therapy with the combination is more beneficial in comparison to the alternative therapy. The result of this controlled clinical study confirms that the combination Xylometazoline-Dexpanthenol is an enlargement and improvement of effective medicinal treatment of rhinitis following nasal operation in comparison to therapy with Xylometazoline alone.

Impact of specialist home-based palliative care services in a tertiary oncology set up: a prospective non-randomized observational study.

PubMed

Dhiliwal, Sunil R; Muckaden, Maryann

2015-01-01

Home-based specialist palliative care services are developed to meet the needs of the patients in advanced stage of cancer at home with physical symptoms and distress. Specialist home care services are intended to improve symptom control and quality of life, enable patients to stay at home, and avoid unnecessary hospital admission. Total 690 new cases registered under home-based palliative care service in the year 2012 were prospectively studied to assess the impact of specialist home-based services using Edmonton symptom assessment scale (ESAS) and other parameters. Out of the 690 registered cases, 506 patients received home-based palliative care. 50.98% patients were cared for at home, 28.85% patients needed hospice referral and 20.15% patients needed brief period of hospitalization. All patients receiving specialist home care had good relief of physical symptoms (P < 0.005). 83.2% patients received out of hours care (OOH) through liaising with local general practitioners; 42.68% received home based bereavement care and 91.66% had good bereavement outcomes. Specialist home-based palliative care improved symptom control, health-related communication and psychosocial support. It promoted increased number of home-based death, appropriate and early hospice referral, and averted needless hospitalization. It improved bereavement outcomes, and caregiver satisfaction.

Public reporting as a prescriptions quality improvement measure in primary care settings in China: variations in effects associated with diagnoses

PubMed Central

Tang, Yuqing; Liu, Chaojie; Zhang, Xinping

2016-01-01

The overprovision and irrational use of antibiotics and injections are a major public health concern. Public reporting has been adopted as a strategy to encourage good prescribing practices. This study evaluated the effects of public reporting on antibiotic and injection prescriptions in urban and rural primary care settings in Hubei province, China. A randomized control trial was conducted, with 10 primary care institutions being subject to public reporting and another 10 serving as controls. Prescription indicators were publicly reported monthly over a one-year period. Prescriptions for bronchitis, gastritis and hypertension before and after the intervention were collected. Difference-in-difference tests were performed to estimate the effect size of the intervention on five prescription indicators: percentage of prescriptions containing antibiotics; percentage of prescriptions containing two or more antibiotics; percentage of prescriptions containing injections; percentage of prescriptions containing antibiotic injections; and average prescription cost. Public reporting had varied effects on prescriptions for different diagnoses. It reduced antibiotic prescribing for gastritis. Prescriptions containing injections, especially antibiotic injections, also declined, but only for gastritis. A reduction of prescription costs was noted for bronchitis and gastritis. Public reporting has the potential to encourage good prescribing practices. Its effects vary with different disease conditions. PMID:27996026

Clinical observation of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma: a prospective randomized controlled study of 32 cases.

PubMed

Zhang, Xiangmin; Liu, Folin; Lan, Xiaolin; Yu, Lijiang; Wu, Wei; Wu, Xiuhong; Xiao, Fufu; Li, Shaojin

2014-02-21

The aim of this study was to evaluate the clinical efficacy of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma. Using the randomized controlled clinical research method, 65 patients with nasopharyngeal carcinoma were randomly divided into an experimental group consisting of 32 patients and a control group consisting of 33 patients. The submandibular glands were averted to the submental region in 32 patients with nasopharyngeal carcinoma before they received conventional radiotherapy; a lead block was used to shield the submental region during therapy. Prior to radiotherapy, the function of the submandibular glands was assessed using imaging. Submandibular gland function was measured using 99mTc radionuclide scanning at 60 months after radiotherapy. The data in the questionnaire regarding the degree of xerostomia were investigated and saliva secretion was measured at 3, 6, 12, and 60 months after radiotherapy. In addition, the 5-year survival rate was calculated. After follow-up for 3, 6, and 12 months, the incidence of moderate to severe xerostomia was significantly lower in the experimental group than in the control group. The average amount of saliva produced by the experimental and control groups was 1.60 g and 0.68 g, respectively (P<0.001). After follow-up for 60 months, the uptake and secretion functions of the submandibular glands in the experimental group were found to be significantly higher than in the control group (P<0.001 and P<0.001, respectively). The incidence of moderate or severe xerostomia was significantly lower than in the control group (15.4% and 76.9%, respectively; P<0.001). The 5-year survival rates of the experimental group and the control group were 81.3% and 78.8%, respectively, and there was no significant difference between the two groups (P=0.806). After a 5 year follow-up period involving 32 patients who had their submandibular glands transferred for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma, we found that clinical efficacy was good. This approach could improve the quality of life of nasopharyngeal carcinoma patients after radiotherapy and would not affect long-term treatment efficacy.

Clinical observation of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma: a prospective randomized controlled study of 32 cases

PubMed Central

2014-01-01

Background The aim of this study was to evaluate the clinical efficacy of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma. Methods Using the randomized controlled clinical research method, 65 patients with nasopharyngeal carcinoma were randomly divided into an experimental group consisting of 32 patients and a control group consisting of 33 patients. The submandibular glands were averted to the submental region in 32 patients with nasopharyngeal carcinoma before they received conventional radiotherapy; a lead block was used to shield the submental region during therapy. Prior to radiotherapy, the function of the submandibular glands was assessed using imaging. Submandibular gland function was measured using 99mTc radionuclide scanning at 60 months after radiotherapy. The data in the questionnaire regarding the degree of xerostomia were investigated and saliva secretion was measured at 3, 6, 12, and 60 months after radiotherapy. In addition, the 5-year survival rate was calculated. Results After follow-up for 3, 6, and 12 months, the incidence of moderate to severe xerostomia was significantly lower in the experimental group than in the control group. The average amount of saliva produced by the experimental and control groups was 1.60 g and 0.68 g, respectively (P < 0.001). After follow-up for 60 months, the uptake and secretion functions of the submandibular glands in the experimental group were found to be significantly higher than in the control group (P < 0.001 and P < 0.001, respectively). The incidence of moderate or severe xerostomia was significantly lower than in the control group (15.4% and 76.9%, respectively; P < 0.001). The 5-year survival rates of the experimental group and the control group were 81.3% and 78.8%, respectively, and there was no significant difference between the two groups (P = 0.806). Conclusions After a 5 year follow-up period involving 32 patients who had their submandibular glands transferred for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma, we found that clinical efficacy was good. This approach could improve the quality of life of nasopharyngeal carcinoma patients after radiotherapy and would not affect long-term treatment efficacy. PMID:24555575

Using augmented reality to inform consumer choice and lower carbon footprints

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

Isley, Steven C.; Ketcham, Robert; Arent, Douglas J.

Consumers who wish to consider product attributes like carbon footprints in their purchasing decisions are often blocked from meaningful action by a lack of information. We conducted a single randomized controlled trial at a grocery store to evaluate the effects of providing such product attribute and carbon footprint information via augmented reality (AR) displays on bottled water and breakfast cereal, two frequently purchased goods. Using an AR smartphone app that incorporates comparative and detailed product information into personalized data and recommendations, a 23% statistically significant reduction in carbon footprint was found for bottled water, and non-significant reductions for breakfast cereal.more » Furthermore, AR informed choice lead to healthier cereal choices.« less

Using augmented reality to inform consumer choice and lower carbon footprints

DOE PAGES

Isley, Steven C.; Ketcham, Robert; Arent, Douglas J.

2017-05-23

Consumers who wish to consider product attributes like carbon footprints in their purchasing decisions are often blocked from meaningful action by a lack of information. We conducted a single randomized controlled trial at a grocery store to evaluate the effects of providing such product attribute and carbon footprint information via augmented reality (AR) displays on bottled water and breakfast cereal, two frequently purchased goods. Using an AR smartphone app that incorporates comparative and detailed product information into personalized data and recommendations, a 23% statistically significant reduction in carbon footprint was found for bottled water, and non-significant reductions for breakfast cereal.more » Furthermore, AR informed choice lead to healthier cereal choices.« less

Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

PubMed Central

2013-01-01

Purpose Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Methods Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. Results No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. Conclusion The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities. PMID:23819489

Continuous wound infusion and local infiltration analgesia for postoperative pain and rehabilitation after total hip arthroplasty.

PubMed

Fusco, Pierfrancesco; Cofini, Vincenza; Petrucci, Emiliano; Scimia, Paolo; Fiorenzi, Maurizio; Paladini, Giuseppe; Behr, Astrid U; Borghi, Battista; Flamini, Stefano; Pizzoferrato, Renzo; Colafarina, Olivo; Di Francesco, Alexander; Tabacco, Tito; Necozione, Stefano; Marinangeli, Franco

2018-05-01

Total hip arthroplasty is one of the most common procedures in orthopedic surgery. We hypothesized that local infiltration of analgesia and continuous wound infusion of anesthetics in the first 72 hours after surgery could provide more effective postoperative analgesia with better rehabilitation. A double-blind, randomized, controlled study was conducted with 96 patients who underwent total hip arthroplasty. The patients were randomized to receive either a local infiltration analgesia and continuous wound infusion of anesthetics or a local infiltration analgesia and continuous wound infusion of saline solution. The patients in both groups received subarachnoid anesthesia and a local infiltration analgesia. A multihole catheter was placed next to the implant and connected to an electronic pump containing a 300-mL solution of 0.2% levobupivacaine (experimental group) or saline (control group). A total of 96 consecutive patients were enrolled and randomized. Of these, 48 patients received local infiltration analgesia and continuous wound infusion of local anesthetics, and the remainder received local infiltration analgesia and continuous wound infusion of saline solution. The analysis showed a significant main effect of treatment on the postoperative incident of pain (Ftreat(1,93)=22.62, P=0.000) and on resting pain during the post-surgery follow-up (Ftreat(1,93)=15.62, P=0.0002). The pain scores during the rehabilitation period were significantly less in the experimental group. Analgesic consumption was less in the experimental group. The addition of continuous wound infusion of anesthetics to local infiltration analgesia provided an extended analgesic effect associated with good rehabilitation performance.

The effect of Polygonum minus extract on cognitive and psychosocial parameters according to mood status among middle-aged women: a randomized, double-blind, placebo-controlled study

PubMed Central

Shahar, Suzana; Aziz, Ainor Farahin; Ismail, Siti Nur Arina; Yahya, Hanis Mastura; Din, Normah Che; Manaf, Zahara Abdul; Badrasawi, Manal M

2015-01-01

Background Polygonum minus (PM) or locally known in Malaysia, as “kesum” is rich in micronutrients and natural antioxidants. However, its beneficial effect on outcome associates with oxidative stress including cognitive function is yet to be discovered. We assessed the efficacy of PM extract (LineMinus™) on cognitive function and psychosocial status among middle-aged women in Klang Valley of Malaysia. Methods A randomized, double-blind, placebo-controlled trial among 35 healthy middle-aged women was performed, and subjects were randomized to receive either 250 mg PM or placebo of 100 mg maltodextrin each were taken twice daily for 6 weeks. Subjects were assessed for neuropsychological test, psychosocial status, and anthropometric at baseline, week 3, and week 6. Biomarkers were also determined at baseline and week 6. Results The supplementation of PM showed significant intervention effect on Digit Span test (P<0.05) social functioning domain of 36-Item Short Form Health Survey (P<0.05) among subjects with mood disturbance. While, among subjects with good mood, PM supplementation improved Wechsler Abbreviated Scale of Intelligence (WASI) for IQ verbal (P=0.016) and Full Scale IQ of WASI (P=0.004). There were no adverse effects reported for the supplementation as indicated using biomarkers, including liver function and clinical symptoms. Conclusion Supplementation of PM is safe to be consumed for 6 weeks, with potential benefits to attention, short-term memory, improved quality of life, and mood, as well as IQ. PMID:26445532

Brief psychosocial therapy for the treatment of agitation in Alzheimer disease (the CALM-AD trial).

PubMed

Ballard, Clive; Brown, Richard; Fossey, Jane; Douglas, Simon; Bradley, Paul; Hancock, Judith; James, Ian A; Juszczak, Edmund; Bentham, Peter; Burns, Alistair; Lindesay, James; Jacoby, Robin; O'Brien, John; Bullock, Roger; Johnson, Tony; Holmes, Clive; Howard, Robert

2009-09-01

Good practice guidelines state that a psychological intervention should usually precede pharmacotherapy, but there are no data evaluating the feasibility of psychological interventions used in this way. At the first stage of a randomized blinded placebo-controlled trial, 318 patients with Alzheimer disease (AD) with clinically significant agitated behavior were treated in an open design with a psychological intervention (brief psychosocial therapy [BPST]) for 4 weeks, preceding randomization to pharmacotherapy. The therapy involved social interaction, personalized music, or removal of environmental triggers. Overall, 318 patients with AD completed BPST with an improvement of 5.6 points on the total Cohen-Mansfield Agitation Inventory (CMAI; mean [SD], 63.3 [16.0] to 57.7 [18.4], t = 4.8, df = 317, p < 0.0001). Therapy worksheets were completed in six of the eight centers, with the key elements of the intervention delivered according to the manual for >95% of patients. More detailed evaluation of outcome was completed for the 198 patients with AD from these centers, who experienced a mean improvement of 6.6 points on the total CMAI (mean [SD], 62.2 [14.3] to 55.6 [15.8], t = 6.5, df = 197, p < 0.0001). Overall, 43% of participants achieved a 30% improvement in their level of agitation. The specific attributable benefits of BPST cannot be determined from an open trial. However, the BPST therapy was feasible and was successfully delivered according to an operationalized manual. The encouraging outcome indicates the need for a randomized controlled trial of BPST.

Seminar on Understanding Digital Control and Analysis in Vibration Test Systems, part 2

NASA Technical Reports Server (NTRS)

1975-01-01

A number of techniques for dealing with important technical aspects of the random vibration control problem are described. These include the generation of pseudo-random and true random noise, the control spectrum estimation problem, the accuracy/speed tradeoff, and control correction strategies. System hardware, the operator-system interface, safety features, and operational capabilities of sophisticated digital random vibration control systems are also discussed.

[Case-control study on T-shaped locking internal fixation and external fixation for the treatment of dorsal Barton's fracture].

PubMed

Chen, Huan-qing; Wen, Xi-le; Li, Yang-ming; Wen, Cong-you

2015-06-01

To compare clinical effect of T-shaped locking internal fixation and external fixation in treating dorsal Barton's fracture,and investigate selective strategy of internal fixation. From January 2008 to January 2013, 100 patients with dorsal Barton's fracture were randomly divided into two groups. In treatment group, there were 30 males and 20 females with an average age of (33.8±3.6) years old;30 cases were type B, 20 cases were type C;and treated with T-shaped locking internal fixation. In control group, there were 32 male and 18 females with an average age of (32.9±3.4) years old; 29 cases were type B, 21 cases were type C; and treated with external fixation. Volar tilt, ulnar deviation and radial height at 3 months after operation were detected and compared between two groups. Mechara functional evaluation were used to evaluate postoperative clinical effects. Clinical cure time, postoperative complications,joint mobility and function score were recorded and compared between two groups. In treatment group,volar tilt was (11.9±2.7)°, ulnar deviation was (20.8+ 2.9)°,and radial height was (10.9±1.8) mm; while volar tilt was (9.1±1.6)°, ulnar deviation was (17.1±2.9)°, and radial height was (8.1±1.5) mm in control group. Treatment group was better than control group in volar tilt, ulnar deviation and radial height. Clinical cure time in treatment group was(12.0±2.3) weeks, shorter than control group (18.0±4.1) weeks. The incidence of complications in treatment group was lower than control group. According to Mehara functional evaluation,20 cases got excellent results, 25 good, 3 moderate and 2 poor in treatment group; 16 cases got excellent results, 14 good, 10 moderate and 10 poor in control group. Treatment group was better than control group in clinical effects. T-shaped locking internal fixation with postoperative functional exercise for the treatment of dorsal Barton's fracture fits for biomechanics demands,and has advantages of stable fixation,rapid recovery, less complications and good functional recovery, it has better clinical effects.

Conducting Rigorous Research in Multilingual Context: A Randomized Field Trial of the Good Behavior Game

ERIC Educational Resources Information Center

Kurki, Anja; Wang, Wei; Poduska, Jeanne; Gomez, Mary Jane; Li, Yibing; Brown, C. Hendricks

2012-01-01

This paper describes the design and preliminary results regarding the testing of the Good Behavior Game in schools that vary in their proportion of Latinos and the use of bilingual instruction. The authors discuss how working with multicultural schools/school district has influenced the design, intervention and training, data collection, and…

A Gompertzian model with random effects to cervical cancer growth

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

Mazlan, Mazma Syahidatul Ayuni; Rosli, Norhayati

2015-05-15

In this paper, a Gompertzian model with random effects is introduced to describe the cervical cancer growth. The parameters values of the mathematical model are estimated via maximum likehood estimation. We apply 4-stage Runge-Kutta (SRK4) for solving the stochastic model numerically. The efficiency of mathematical model is measured by comparing the simulated result and the clinical data of the cervical cancer growth. Low values of root mean-square error (RMSE) of Gompertzian model with random effect indicate good fits.

31 CFR 560.306 - Iranian-origin goods or services; goods or services owned or controlled by the Government of Iran.

Code of Federal Regulations, 2013 CFR

2013-07-01

...; goods or services owned or controlled by the Government of Iran. 560.306 Section 560.306 Money and... Iranian-origin goods or services; goods or services owned or controlled by the Government of Iran. (a) The..., extracted, or processed in Iran; and (2) Goods which have entered into Iranian commerce. (b) The terms...

31 CFR 560.306 - Iranian-origin goods or services; goods or services owned or controlled by the Government of Iran.

Code of Federal Regulations, 2014 CFR

2014-07-01

...; goods or services owned or controlled by the Government of Iran. 560.306 Section 560.306 Money and... Iranian-origin goods or services; goods or services owned or controlled by the Government of Iran. (a) The..., extracted, or processed in Iran; and (2) Goods which have entered into Iranian commerce. (b) The terms...

A meta-analysis of long follow-up outcomes of laparoscopic Nissen (total) versus Toupet (270°) fundoplication for gastro-esophageal reflux disease based on randomized controlled trials in adults.

PubMed

Du, Xing; Hu, Zhiwei; Yan, Chao; Zhang, Chao; Wang, Zhonggao; Wu, Jimin

2016-08-02

Laparoscopic Nissen fundoplication (LNF) is the most common surgical procedure for the surgical management of gastro-esophageal reflux disease (GERD). Laparoscopic Toupet fundoplication (LTF) has been reported to have a lower prevalence of postoperative complications yet still obtain a similar level of reflux control. We conducted a meta-analysis to confirm the value of LNF and LTF. PubMed, Medline, Embase, Cochrane Library and Springerlink were searched for randomized controlled trials (RCTs) comparing LNF and LTF. Data regarding the benefits and adverse results of two techniques were extracted and compared using a meta-analysis. Eight eligible RCTs comparing LNF (n = 625) and LTF (n = 567) were identified. There were no significant differences between LNF and LTF with regard to hospitalization duration, perioperative complications, patient satisfaction, postoperative heartburn, regurgitation, postoperative DeMeester scores, or esophagites. A shorter operative time and higher postoperative lower esophageal sphincter pressure were associated with LNF. Prevalence of postoperative dysphagia, gas-bloating, inability to belch, dilatation for dysphagia and reoperation were higher after LNF, but subgroup analyses showed that differences with respect to dysphagia between LNF and LTF disappeared over time. Subgroup analyses did not support "tailored therapy" according to preoperative esophageal motility. LNF and LTF have equivalently good control of GERD and result in a similar prevalence of patient satisfaction. Based on current evidence, it is not rational or advisable to abandon LNF when choosing a surgical procedure for GERD.

Effect of the good school toolkit on school staff mental health, sense of job satisfaction and perceptions of school climate: Secondary analysis of a cluster randomised trial.

PubMed

Kayiwa, Joshua; Clarke, Kelly; Knight, Louise; Allen, Elizabeth; Walakira, Eddy; Namy, Sophie; Merrill, Katherine G; Naker, Dipak; Devries, Karen

2017-08-01

The Good School Toolkit, a complex behavioural intervention delivered in Ugandan primary schools, has been shown to reduce school staff-perpetrated physical violence against students. We aimed to assess the effect of this intervention on staff members' mental health, sense of job satisfaction and perception of school climate. We analysed data from a cluster-randomised trial administered in 42 primary schools in Luwero district, Uganda. The trial was comprised of cross-sectional baseline (June/July 2012) and endline (June/July 2014) surveys among staff and students. Twenty-one schools were randomly selected to receive the Toolkit, whilst 21 schools constituted a wait-listed control group. We generated composite measures to assess staff members' perceptions of the school climate and job satisfaction. The trial is registered at clinicaltrials.gov (NCT01678846). No schools dropped out of the study and all 591 staff members who completed the endline survey were included in the analysis. Staff in schools receiving the Toolkit had more positive perspectives of their school climate compared to staff in control schools (difference in mean scores 2.19, 95% Confidence Interval 0.92, 3.39). We did not find any significant differences for job satisfaction and mental health. In conclusion, interventions like the Good School Toolkit that reduce physical violence by school staff against students can improve staff perceptions of the school climate, and could help to build more positive working and learning environments in Ugandan schools. Copyright © 2017 Elsevier Inc. All rights reserved.

Cooking does not decrease hydrophilic antioxidant capacity of wild blueberries.

PubMed

Murphy, Rebecca Ree; Renfroe, Michael H; Brevard, Patricia Bowling; Lee, Robert E; Gloeckner, Janet W

2009-01-01

The present study examined the effects of domestic cooking methods on the hydrophilic antioxidant activity (HAA) of wild blueberries. Baked, microwaved, simmered, and pan-fried frozen wild blueberries, and a thawed uncooked control, were analyzed for HAA using an ABTS/H(2)O(2)/HRP decoloration method. All cooking treatments were derived from recipes using wild blueberries, and were performed in triplicate. A randomized block design was used to determine whether there were statistical differences in antioxidant content after cooking and between each of the trials. There were no statistically significant decreases after cooking the thawed berries. On both a fresh weight and a dry weight basis, pan-fried blueberries had significantly higher HAA than baked, simmered, and control blueberries (P<0.05). Antioxidants in wild blueberries appear to be heat stable since cooked berries retained significant HAA. Cooked wild blueberries can be recommended as a good source of dietary antioxidants.

Efficacy and tolerability of Hairgain in individuals with hair loss: a placebo-controlled, double-blind study.

PubMed

Thom, E

2001-01-01

This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of a new agent for the treatment of hair loss, based on a marine protein, minerals and vitamins. Sixty subjects with hair loss of different aetiologies participated in the 6-month blinded phase of the study. Objective assessments indicated that the treatment was effective and subjective assessments showed a statistically significant positive effect of treatment. Exposure to the active preparation for a further 6 months in an open phase indicated a further improvement in hair growth. Exposure of the patients previously treated with placebo to the active preparation for 12 months gave similar results. Tolerability was good and no side-effects were reported. The product investigated may provide an alternative to pharmacotherapy for the treatment of hair-loss problems in individuals with androgenic alopecia.

Fixed-rate layered multicast congestion control

NASA Astrophysics Data System (ADS)

Bing, Zhang; Bing, Yuan; Zengji, Liu

2006-10-01

A new fixed-rate layered multicast congestion control algorithm called FLMCC is proposed. The sender of a multicast session transmits data packets at a fixed rate on each layer, while receivers each obtain different throughput by cumulatively subscribing to deferent number of layers based on their expected rates. In order to provide TCP-friendliness and estimate the expected rate accurately, a window-based mechanism implemented at receivers is presented. To achieve this, each receiver maintains a congestion window, adjusts it based on the GAIMD algorithm, and from the congestion window an expected rate is calculated. To measure RTT, a new method is presented which combines an accurate measurement with a rough estimation. A feedback suppression based on a random timer mechanism is given to avoid feedback implosion in the accurate measurement. The protocol is simple in its implementation. Simulations indicate that FLMCC shows good TCP-friendliness, responsiveness as well as intra-protocol fairness, and provides high link utilization.

Comparing spatial regression to random forests for large ...

EPA Pesticide Factsheets

Environmental data may be “large” due to number of records, number of covariates, or both. Random forests has a reputation for good predictive performance when using many covariates, whereas spatial regression, when using reduced rank methods, has a reputation for good predictive performance when using many records. In this study, we compare these two techniques using a data set containing the macroinvertebrate multimetric index (MMI) at 1859 stream sites with over 200 landscape covariates. Our primary goal is predicting MMI at over 1.1 million perennial stream reaches across the USA. For spatial regression modeling, we develop two new methods to accommodate large data: (1) a procedure that estimates optimal Box-Cox transformations to linearize covariate relationships; and (2) a computationally efficient covariate selection routine that takes into account spatial autocorrelation. We show that our new methods lead to cross-validated performance similar to random forests, but that there is an advantage for spatial regression when quantifying the uncertainty of the predictions. Simulations are used to clarify advantages for each method. This research investigates different approaches for modeling and mapping national stream condition. We use MMI data from the EPA's National Rivers and Streams Assessment and predictors from StreamCat (Hill et al., 2015). Previous studies have focused on modeling the MMI condition classes (i.e., good, fair, and po

[Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].

PubMed

Kong, Wei-ping; Tao, Qing-wen; Zhang, Ying-ze; Yang, Shu; Xu, Yuan; Zhu, Xiao-xia; Jin, Yue; Yang, Wen-xue; Yan, Xiao-ping

2015-06-01

To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients. A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment. After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P < 0.05]. Scores for CM syndromes, BASDAI, night pain index, spinal pain index, PGA, CRP were improved in the BSG group (P < 0.05, P < 0.01). The incidence of adverse events in the BSG group was lower than that of the control group. BSG based on Shen supplementing, Du-channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

Study protocol: The Technology-Enhanced Coaching (TEC) program to improve diabetes outcomes – A randomized controlled trial

PubMed Central

Heisler, Michele; Mase, Rebecca; Brown, Brianne; Wilson, Shayla; Reeves, Pamela J.

2017-01-01

Background Racial and ethnic minority adults with diabetes living in under-resourced communities face multiple barriers to sustaining self-management behaviors necessary to improve diabetes outcomes. Peer support and decision support tools each have been associated with improved diabetes outcomes. Methods 289 primarily African American adults with poor glycemic control will be recruited from the Detroit Veteran’s Administration Hospital and randomized to Technology-Enhanced Coaching (TEC) or Peer Coaching alone. Participants in both arms will be assigned a peer coach trained in autonomy-supportive approaches. Coaches are diabetes patients with prior poor glycemic control who now have good control. All participants meet face-to-face initially with their coach to review diabetes education materials and develop an action plan. Educational materials in the TEC arm are delivered via a web-based, educational tool tailored with each participant’s personalized health data (iDecide). Over the next six months, Coaches call their assigned participants once a week to provide support for weekly action steps. Data are also collected on an Observational Control group with no contact with study staff. Changes in A1c, blood pressure, other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. Discussion Tailored e-Health tools with educational content may enhance the effectiveness of peer coaching programs to better prepare patients to set self-management goals, identify action plans, and discuss treatment options with their health care providers. The study will provide insights for scalable self-management support programs for diabetes and chronic illnesses that require high levels of sustained patient self-management. PMID:28132876

Acupuncture paired with herbal medicine for prediabetes: study protocol for a randomized controlled trial.

PubMed

Li, Xinger; Liu, Haiyan; Feng, Huiping; Xian, Zhongren; Chen, Yanhong; Chen, Jianping; Tang, Chunzhi; Lai, Xinsheng; Lan, Xiaoling; Huang, Huanzhen; Yu, Dongdong

2017-06-28

Type-2 diabetes has become a major disease and is known to seriously impair people's health worldwide. Prediabetes includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) and is the most critical period for preventing type-2 diabetes, as it can be identified and reversed. Studies in the past decade have indicated that acupuncture and Chinese herbal medicine may be beneficial for treating prediabetes. However, a randomized controlled trial (RCT) should be conducted to obtain more clinical evidence on this topic. An RCT will be implemented in this study, using a72-week study period (24 weeks for the intervention and 48 weeks for follow-up). Participants will be recruited from the Fifth Affiliated Hospital of Guangzhou Medical University in China. Eighty participants will be randomized to the treatment group (acupuncture plus herbal medicine and health education) or the control group (health education only), 40 participants in each. People included in this study must have been diagnosed with prediabetes using Western medicine criteria. The endpoint indices include the incidence of diabetes mellitus and the reversion rate. The primary outcome is fasting plasma glucose (FPG) level, 2-h plasma glucose (2-hPG) level after a 75-g oral glucose tolerance test (OGTT), and glycosylated hemoglobin (HbA 1c ) level. Secondary outcomes include the following: Body Mass Index (BMI); hemorheology, including shear rates of whole-blood viscosity and plasma viscosity. Safety indices include hepatic (ALT, AST) and renal function (BUN, Cr) and records of adverse events, including diarrhoea, colds, pharyngitis, and sleep disorders. Quality control will be implemented, including quality control of the laboratory, researchers, participants, investigational drugs, data and documents, occurrence of bias, supervision, among others, according to uniform standard operating procedures (SOPs) which have been established by the Good Clinical Practice (GCP) office of the Fifth Affiliated Hospital of Guangzhou Medical University. The aim of this study is to evaluate the efficacy and safety of acupuncture paired with herbal medicine for the treatment of patients with prediabetes. Chinese clinical trials register ChiCTR-INR-16008891 . Registered on 23 July 2016.

Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial.

PubMed

Firouzi, Somayyeh; Majid, Hazreen Abdul; Ismail, Amin; Kamaruddin, Nor Azmi; Barakatun-Nisak, Mohd-Yusof

2017-06-01

Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation-also refers to multi-strain probiotics-on glycemic control and other diabetes-related outcomes in people with type 2 diabetes. A randomized, double-blind, parallel-group, controlled clinical trial. Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia. A total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks. Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract. Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate. With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p < 0.05, small effect size of 0.050), while these changes were not significant in ITT analysis. Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis. These changes were significant between groups at both analyses (p < 0.05, medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis). Secondary outcomes did not change significantly. Probiotics successfully passed through the gastrointestinal tract. Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes.

Sequential change detection and monitoring of temporal trends in random-effects meta-analysis.

PubMed

Dogo, Samson Henry; Clark, Allan; Kulinskaya, Elena

2017-06-01

Temporal changes in magnitude of effect sizes reported in many areas of research are a threat to the credibility of the results and conclusions of meta-analysis. Numerous sequential methods for meta-analysis have been proposed to detect changes and monitor trends in effect sizes so that meta-analysis can be updated when necessary and interpreted based on the time it was conducted. The difficulties of sequential meta-analysis under the random-effects model are caused by dependencies in increments introduced by the estimation of the heterogeneity parameter τ 2 . In this paper, we propose the use of a retrospective cumulative sum (CUSUM)-type test with bootstrap critical values. This method allows retrospective analysis of the past trajectory of cumulative effects in random-effects meta-analysis and its visualization on a chart similar to CUSUM chart. Simulation results show that the new method demonstrates good control of Type I error regardless of the number or size of the studies and the amount of heterogeneity. Application of the new method is illustrated on two examples of medical meta-analyses. © 2016 The Authors. Research Synthesis Methods published by John Wiley & Sons Ltd. © 2016 The Authors. Research Synthesis Methods published by John Wiley & Sons Ltd.

Evaluation of a home-based exercise program in the treatment of Alzheimer's disease: the Maximizing Independence in Dementia (MIND) study.

PubMed

Steinberg, Martin; Leoutsakos, Jeannie-Marie Sheppard; Podewils, Laura Jean; Lyketsos, C G

2009-07-01

To determine the feasibility and efficacy of a home-based exercise intervention program to improve the functional performance of patients with Alzheimer's Disease (AD). Twenty-seven home-dwelling patients with AD were randomized to either an exercise intervention program delivered by their caregivers or a home safety assessment control. Measures of functional performance (primary), cognition, neuropsychiatric symptoms, quality of life and caregiver burden (secondary) were obtained at baseline and at 6 and 12 weeks following randomization. For each outcome measure, intent-to-treat analyses using linear random effects models were performed. Feasibility and adverse events were also assessed. Adherence to the exercise program was good. On the primary outcomes (functional performance) patients in the exercise group demonstrated a trend for improved performance on measures of hand function and lower extremity strength. On secondary outcome measures, trends toward worse depression and lower quality of life ratings were noted. The physical exercise intervention developed for the study, delivered by caregivers to home-dwelling patients with AD, was feasible and was associated with a trend for improved functional performance in this group of frail patients. Given the limited efficacy to date of pharmacotherapies for AD, further study of exercise intervention, in a variety of care setting, is warranted.

A comparison of the efficacy of powered and manual toothbrushes in controlling plaque and gingivitis: a clinical study

PubMed Central

Jain, Yashika

2013-01-01

Background Plaque is intimately related to the production and progress of dental caries and inflammatory gingival and periodontal diseases. Good plaque control facilitates the return to health for patients with gingival and periodontal diseases. Daily use of a toothbrush and other oral hygiene aids is the most dependable way to achieve oral health benefits for all patients. Methods A randomized clinical trial was conducted to compare the efficacy of a powered toothbrush with a manual toothbrush in controlling plaque and gingivitis over a 6-week period. The sample consisted of 60 dental students of both sexes, with ages ranging from 18 to 28 years. The samples were stratified and randomly divided into two groups of 30 by a second examiner using the coin toss method; one group used a manual toothbrush and the other group used a powered toothbrush. Each participant’s gingival index, plaque index and oral hygiene index were assessed on the seventh, 14th, and 45th days on the basis of the assigned toothbrush. Collected data were analyzed and different subgroups were compared using Student’s t-test. Results A paired t-test revealed a highly significant reduction in the gingival, plaque, and oral hygiene index scores of the manual and powered groups at the first, second, and sixth weeks (P-value < 0.0001). An unpaired t-test revealed a significant reduction between the plaque index scores of the manual and powered groups at the second week (P-value < 0.05). Another unpaired t-test revealed a highly significant reduction between the plaque index scores of the manual and powered groups at the sixth week (P-value < 0.0001). Conclusion The subject group using the powered toothbrush demonstrated clinical and statistical improvement in overall plaque scores. Powered toothbrushes offer an individual the ability to brush the teeth in a way that is optimal in terms of removing plaque and improving gingival health, conferring good brushing technique on all who use them, irrespective of manual dexterity or training. PMID:23674927

Lumbar spinous process splitting decompression provides equivalent outcomes to conventional midline decompression in degenerative lumbar canal stenosis: a prospective, randomized controlled study of 51 patients.

PubMed

Rajasekaran, S; Thomas, Ashok; Kanna, Rishi M; Prasad Shetty, Ajoy

2013-09-15

Prospective, randomized controlled study. To compare the functional outcomes and extent of paraspinal muscle damage between 2 decompressive techniques for lumbar canal stenosis. Lumbar spinous process splitting decompression (LSPSD) preserves the muscular and liga-mentous attachments of the posterior elements of the spine. It can potentially avoid problems such as paraspinal muscle atrophy and trunk extensor weakness that can occur after conventional midline decompression. However, large series prospective randomized controlled studies are lacking. Patients with lumbar canal stenosis were randomly allocated into 2 groups: LSPSD (28 patients) and conventional midline decompression (23 patients). The differences in operative time, blood loss, time to comfortable mobilization, and hospital stay were studied. Paraspinal muscle damage was assessed by postoperative rise in creatine phosphokinase and C-reactive protein levels. Functional outcome was evaluated at 1 year by Japanese Orthopaedic Association score, neurogenic claudication outcome score, and visual analogue scale for back pain and neurogenic claudication. Fifty-one patients of mean age 56 years were followed-up for a mean 14.2 ± 2.9 months. There were no significant differences in the operative time, blood loss, and hospital stay. Both the groups showed significant improvement in the functional outcome scores at 1 year. Between the 2 groups, the Japanese Orthopaedic Association score, neurogenic claudication outcome score improvement, visual analogue scale for back pain, neurogenic claudication visual analogue scale, and the postoperative changes in serum C-reactive protein and creatine phosphokinase levels did not show any statistically significant difference. On the basis of the Japanese Orthopaedic Association recovery rate, it was found that 73.9% of conventional midline decompression group had good outcomes compared with only 60.7% after LSPSD. The functional outcome scores, back pain, and claudication pain in the immediate period and at the end of 1 year are similar in both the techniques. More patients had better functional outcomes after conventional decompression than the LSPSD technique. On the basis of this study, the superiority of one technique compared with the other is not established, mandating the need for further long-term studies. 2.

Efficacy of Noninvasive Stellate Ganglion Blockade Performed Using Physical Agent Modalities in Patients with Sympathetic Hyperactivity-Associated Disorders: A Systematic Review and Meta-Analysis

PubMed Central

Liao, Chun-De; Tsauo, Jau-Yih; Liou, Tsan-Hon

2016-01-01

Background Stellate ganglion blockade (SGB) is mainly used to relieve symptoms of neuropathic pain in conditions such as complex regional pain syndrome and has several potential complications. Noninvasive SGB performed using physical agent modalities (PAMs), such as light irradiation and electrical stimulation, can be clinically used as an alternative to conventional invasive SGB. However, its application protocols vary and its clinical efficacy remains controversial. This study investigated the use of noninvasive SGB for managing neuropathic pain or other disorders associated with sympathetic hyperactivity. Materials and Methods We performed a comprehensive search of the following online databases: Medline, PubMed, Excerpta Medica Database, Cochrane Library Database, Ovid MEDLINE, Europe PubMed Central, EBSCOhost Research Databases, CINAHL, ProQuest Research Library, Physiotherapy Evidence Database, WorldWideScience, BIOSIS, and Google Scholar. We identified and included quasi-randomized or randomized controlled trials reporting the efficacy of SGB performed using therapeutic ultrasound, transcutaneous electrical nerve stimulation, light irradiation using low-level laser therapy, or xenon light or linearly polarized near-infrared light irradiation near or over the stellate ganglion region in treating complex regional pain syndrome or disorders requiring sympatholytic management. The included articles were subjected to a meta-analysis and risk of bias assessment. Results Nine randomized and four quasi-randomized controlled trials were included. Eleven trials had good methodological quality with a Physiotherapy Evidence Database (PEDro) score of ≥6, whereas the remaining two trials had a PEDro score of <6. The meta-analysis results revealed that the efficacy of noninvasive SGB on 100-mm visual analog pain score is higher than that of a placebo or active control (weighted mean difference, −21.59 mm; 95% CI, −34.25, −8.94; p = 0.0008). Conclusions Noninvasive SGB performed using PAMs effectively relieves pain of various etiologies, making it a valuable addition to the contemporary pain management armamentarium. However, this evidence is limited by the potential risk of bias. PMID:27911934

Experimental studies of the effects of buffered particle dampers attached to a multi-degree-of-freedom system under dynamic loads

NASA Astrophysics Data System (ADS)

Lu, Zheng; Lu, Xilin; Lu, Wensheng; Masri, Sami F.

2012-04-01

This paper presents a systematic experimental investigation of the effects of buffered particle dampers attached to a multi-degree-of-freedom (mdof) system under different dynamic loads (free vibration, random excitation as well as real onsite earthquake excitations), and analytical/computational study of such a system. A series of shaking table tests of a three-storey steel frame with the buffered particle damper system are carried out to evaluate the performance and to verify the analysis method. It is shown that buffered particle dampers have good performance in reducing the response of structures under dynamic loads, especially under random excitation case. It can effectively control the fundamental mode of the mdof primary system; however, the control effect for higher modes is variable. It is also shown that, for a specific container geometry, a certain mass ratio leads to more efficient momentum transfer from the primary system to the particles with a better vibration attenuation effect, and that buffered particle dampers have better control effect than the conventional rigid ones. An analytical solution based on the discrete element method is also presented. Comparison between the experimental and computational results shows that reasonably accurate estimates of the response of a primary system can be obtained. Properly designed buffered particle dampers can effectively reduce the response of lightly damped mdof primary system with a small weight penalty, under different dynamic loads.

BounceBack capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study.

PubMed

Udani, Jay K; Singh, Betsy B; Singh, Vijay J; Sandoval, Elizabeth

2009-06-05

Delayed onset muscle soreness (DOMS) is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack, to alleviate the severity of DOMS after standardized eccentric exercise. The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18-45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. In this controlled pilot study, intake of BounceBack capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein) and muscle damage (creatine phosphokinase and myoglobin). BounceBack capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results.

BounceBack™ capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study

PubMed Central

Udani, Jay K; Singh, Betsy B; Singh, Vijay J; Sandoval, Elizabeth

2009-01-01

Background Delayed onset muscle soreness (DOMS) is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack™, to alleviate the severity of DOMS after standardized eccentric exercise. Methods The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18–45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. Results In this controlled pilot study, intake of BounceBack™ capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein) and muscle damage (creatine phosphokinase and myoglobin). Conclusion BounceBack™ capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results. PMID:19500355

Effectiveness of Stress Management Skill Training on the Depression, Anxiety and Stress Levels in Drug Addicts after Drug Withdrawal

PubMed Central

Habibi, Zahra; Tourani, Somayeh; Sadeghi, Hasan; Abolghasemi, Abbass

2013-01-01

Background Stressful life events may cause initiation of drug use among people. The main purpose of this study was to evaluate the effectiveness of stress management skill training on depression, anxiety and stress levels in drug addicts after withdrawal. Objectives The population included all drug addicts after withdrawal in 2012 in Alborz province. Materials and Methods The study was quasi-experimental with pretest-posttest design with a control group. Levels of emotional reactions (depression, anxiety and stress) in all referrals to a counseling center for drug withdrawal in 2012 using the Depression, Anxiety, Stress (DASS-21) questionnaire was assessed. The study population included drug addicts after withdrawal. The sampling method was available sampling and random assignment. Thirty people who had higher emotional reactions were randomly selected and divided into two test (n = 15) and control (n = 15) groups. For the test group, a stress management skill training course was held in twelve 90-minute sessions, but the control group received no intervention. The obtained data were analyzed using SPSS-19 software with analysis of covariance. Results The results showed that stress management skill training has a significant effect on reducing emotional reactions (P < 0.01). It was noted that after 2 months test group follow-up, stress management training has retained its effect. Conclusion Apparently, training addicts about life skills, particularly stress management seems to be a good idea. PMID:24971280

Controlling indoor allergens.

PubMed

Custovic, Adnan; Murray, Clare S; Gore, Robin B; Woodcock, Ashley

2002-05-01

Reading of this article reinforces the reader's knowledge of the role of allergen exposure in relation to asthma and its severity, as well as the relevance of allergen avoidance in the treatment of asthma. Initial literature search for existing evidence-based guidelines, reviews, and meta-analyses was carried out, and further literature searches were performed to review individual randomized controlled trials. Evidence level was graded according to the Scottish Intercollegiate Guidelines Network recommendations. There is good evidence for the link between mite and cockroach allergen exposure and sensitization, and between sensitization and asthma. For pet allergens, some studies found that exposure to pets in early life was associated with specific immunoglobulin E sensitization and allergic disease later in childhood, whereas others reported a protective effect. The effectiveness of allergen reduction in the treatment of asthma is suggested by studies in which the patients improve substantially when moved into the low-allergen environment of hospitals or high-altitude sanatoria. Because of limitations in the design of the most clinical of studies, we do not yet have a conclusive answer on the effectiveness of domestic aeroallergen avoidance. Minimizing the impact of identified environmental risk factors is an important first step to reduce the severity of asthma. Although environmental control is difficult, it should be an integral part of the overall management of sensitized patients. However, what is unclear is which patients would benefit and by how much, and whether the intervention is cost-effective. These questions will be answered satisfactorily only by large randomized trials.

Mechanical versus manual chest compressions for out-of-hospital cardiac arrest: a meta-analysis of randomized controlled trials

PubMed Central

Tang, Lu; Gu, Wan-Jie; Wang, Fei

2015-01-01

Recent evidence regarding mechanical chest compressions in out-of-hospital cardiac arrest (OHCA) is conflicting. The objective of this study was to perform a meta-analysis of randomized controlled trials (RCTs) to compare the effect of mechanical versus manual chest compressions on resuscitation outcomes in OHCA. PubMed, Embase, the Cochrane Central Register of Controlled Trials, and the ClinicalTrials.gov registry were searched. In total, five RCTs with 12,510 participants were included. Compared with manual chest compressions, mechanical chest compressions did not significantly improve survival with good neurological outcome to hospital discharge (relative risks (RR) 0.80, 95% CI 0.61–1.04, P = 0.10; I2 = 65%), return of spontaneous circulation (RR 1.02, 95% CI 0.95–1.09, P = 0.59; I2 = 0%), or long-term (≥6 months) survival (RR 0.96, 95% CI 0.79–1.16, P = 0.65; I2 = 16%). In addition, mechanical chest compressions were associated with worse survival to hospital admission (RR 0.94, 95% CI 0.89–1.00, P = 0.04; I2 = 0%) and to hospital discharge (RR 0.88, 95% CI 0.78–0.99, P = 0.03; I2 = 0%). Based on the current evidence, widespread use of mechanical devices for chest compressions in OHCA cannot be recommended. PMID:26503429

75 FR 16507 - In the Matter of Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-01

... Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and Products Containing Same... synchronous dynamic random access memory controllers and products containing same by reason of infringement of... semiconductor chips having synchronous dynamic random access memory controllers and products containing same...

Trials and Tribulations: The ‘Use’ (and ‘Misuse’) of Evidence in Public Policy

PubMed Central

Deeming, Christopher

2013-01-01

Randomized controlled trials (RCTs) are increasingly playing a central role in shaping policy for development. By comparison, social experimentation has not driven the great transformation of welfare within the developed world. This introduces a range of issues for those interested in the nature of research evidence for making policy. In this article we will seek a greater understanding of why the RCT is increasingly seen as the ‘gold standard’ for policy experiments in low- and middle-income countries (LMICs), but not in the more advanced liberal democracies, and we will explore the implications of this. One objection to the use of RCTs, however can be cost, but implementing policies and programmes without good evidence or a good understanding of their effectiveness is unlikely to be a good use of resources either. Other issues arise. Trials are often complex to run and ethical concerns often arise in social ‘experiments’ with human subjects. However, rolling out untested policies may also be morally objectionable. This article sheds new light on the relationship between evidence and evaluation in public policy in both the global north and developing south. It also tackles emerging issues concerning the ‘use’ and ‘misuse’ of evidence and evaluation within public policy. PMID:23935229

Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making.

PubMed

Berger, Marc L; Sox, Harold; Willke, Richard J; Brixner, Diana L; Eichler, Hans-Georg; Goettsch, Wim; Madigan, David; Makady, Amr; Schneeweiss, Sebastian; Tarricone, Rosanna; Wang, Shirley V; Watkins, John; Mullins, C Daniel

2017-09-01

Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders. Copyright © 2017. Published by Elsevier Inc.

Ultrastructural changes of sheep cumulus-oocyte complexes following different methods of vitrification.

PubMed

Ebrahimi, Bita; Valojerdi, Mojtaba Rezazadeh; Eftekhari-Yazdi, Poopak; Baharvand, Hossein

2012-05-01

To determine the ultrastructural changes of sheep cumulus-oocyte complexes (COCs) following different methods of vitrification, good quality isolated COCs (GV stage) were randomly divided into the non-vitrified control, conventional straw, cryotop and solid surface vitrification groups. In both conventional and cryotop methods, vitrified COCs were respectively loaded by conventional straws and cryotops, and then plunged directly into liquid nitrogen (LN2); whereas in the solid surface group, vitrified COCs were first loaded by cryotops and then cooled before plunging into LN2. Post-warming survivability and ultrastructural changes of healthy COCs in the cryotop group especially in comparison with the conventional group revealed better viability rate and good preservation of the ooplasm organization. However in all vitrification groups except the cryotop group, mitochondria were clumped. Solely in the conventional straw group, the mitochondria showed different densities and were extremely distended. Moreover in the latter group, plenty of large irregular connected vesicles in the ooplasm were observed and in some parts their membrane ruptured. Also, in the conventional and solid surface vitrification groups, cumulus cells projections became retracted from the zona pellucida in some parts. In conclusion, the cryotop vitrification method as compared with other methods seems to have a good post-warming survivability and shows less deleterious effects on the ultrastructure of healthy vitrified-warmed sheep COCs.

Effect of granulocyte-colony stimulating factor on empiric therapy with flomoxef sodium and tobramycin in febrile neutropenic patients with hematological malignancies. Kan-etsu Hematological Disease and Infection Study Group.

PubMed

Yoshida, M; Karasawa, M; Naruse, T; Fukuda, M; Hirashima, K; Oh, H; Ninomiya, H; Abe, T; Saito, K; Shishido, H; Moriyama, Y; Shibata, A; Motoyoshi, K; Nagata, N; Miura, Y

1999-02-01

The clinical effects of concomitant use of granulocyte-colony stimulating factor (G-CSF) on empiric antibiotic therapy in febrile neutropenic patients were evaluated in a randomized fashion. Two hundred and fourteen neutropenic febrile episodes (neutrophil counts < 1.0 x 10(9)/l) were treated with flomoxef sodium and tobramycin with or without G-CSF. The resolution of fever at day 4 (excellent response) or at day 7 (good response) was deemed effective. Among 157 evaluable episodes, the observed excellent responses were 31 (38.8%) and the good responses were 20 (25.0%) in the G-CSF group; those in the control group were 26 (33.8%) and 25 (32.5%), respectively. The overall efficacy rate was 63.8% (51/80) in the G-CSF group and 66.2% (51/77) in the control group (not significant). The initial neutrophil count was 0.186 +/- 0.249 x 10(9)/l in the G-CSF group and 0.235 +/- 0.290 x 10(9)/l in the control group, and rose to 2.889 +/- 4.198 x 10(9)/l and 0.522 +/- 0.844 x 10(9)/l, respectively, at day 7. These results indicate that G-CSF does not affect the rate of response to empiric antibiotic therapy in febrile neutropenic patients, although a significant effect of G-CSF was observed on neutrophil recovery.

Active control of an innovative seat suspension system with acceleration measurement based friction estimation

NASA Astrophysics Data System (ADS)

Ning, Donghong; Sun, Shuaishuai; Li, Hongyi; Du, Haiping; Li, Weihua

2016-12-01

In this paper, an innovative active seat suspension system for vehicles is presented. This seat suspension prototype is built with two low cost actuators each of which has one rotary motor and one gear reducer. A H∞ controller with friction compensation is designed for the seat suspension control system where the friction is estimated and compensated based on the measurement of seat acceleration. This principal aim of this research was to control the low frequency vibration transferred or amplified by the vehicle (chassis) suspension, and to maintain the passivity of the seat suspension at high frequency (isolation vibration) while taking into consideration the trade-off between the active seat suspension cost and its high frequency performance. Sinusoidal excitations of 1-4.5 Hz were applied to test the active seat suspension both when controlled and when uncontrolled and this is compared with a well-tuned passive heavy duty vehicle seat suspension. The results indicate the effectiveness of the proposed control algorithm within the tested frequencies. Further tests were conducted using the excitations generated from a quarter-car model under bump and random road profiles. The bump road tests indicate the controlled active seat suspension has good transient response performance. The Power Spectral Density (PSD) method and ISO 2631-1 standards were applied to analyse the seat suspension's acceleration under random road conditions. Although some low magnitude and high frequency noise will inevitably be introduced by the active system, the weighted-frequency Root Mean Square (RMS) acceleration shows that this may not have a large effect on ride comfort. In fact, the ride comfort is improved from being an 'a little uncomfortable' to a 'not uncomfortable' level when compared with the well-tuned passive seat suspension. This low cost active seat suspension design and the proposed controller with the easily measured feedback signals are very practical for real applications.

All optical mode controllable Er-doped random fiber laser with distributed Bragg gratings.

PubMed

Zhang, W L; Ma, R; Tang, C H; Rao, Y J; Zeng, X P; Yang, Z J; Wang, Z N; Gong, Y; Wang, Y S

2015-07-01

An all-optical method to control the lasing modes of Er-doped random fiber lasers (RFLs) is proposed and demonstrated. In the RFL, an Er-doped fiber (EDF) recoded with randomly separated fiber Bragg gratings (FBG) is used as the gain medium and randomly distributed reflectors, as well as the controllable element. By combining random feedback of the FBG array and Fresnel feedback of a cleaved fiber end, multi-mode coherent random lasing is obtained with a threshold of 14 mW and power efficiency of 14.4%. Moreover, a laterally-injected control light is used to induce local gain perturbation, providing additional gain for certain random resonance modes. As a result, active mode selection of the RFL is realized by changing locations of the laser cavity that is exposed to the control light.

Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

PubMed

Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

2013-12-01

Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

A pilot randomized controlled trial of cognitive behavioral therapy for perinatal depression adapted for women with low incomes.

PubMed

O'Mahen, Heather; Himle, Joseph A; Fedock, Gina; Henshaw, Erin; Flynn, Heather

2013-07-01

Perinatal women with identified depression in prenatal care settings have low rates of engagement and adherence with depression-specific psychotherapy. We report the feasibility and symptom outcomes of Cognitive Behavioral Therapy (CBT) modified (mCBT) to address the needs of perinatal, low-income women with Major Depressive Disorder (MDD). Pregnant women (n = 1421) were screened for depressive symptoms in obstetrics clinics in conjunction with prenatal care visits. A total of 59 women met diagnostic criteria for MDD; 55 women were randomly assigned to mCBT or Treatment as Usual (TAU). The mCBT intervention included an initial engagement session, outreach, specific perinatal content and interpersonal components. Measures were gathered at pre-treatment, 16 week post-randomization, and 3-month follow-up. Most participants attended at least one CBT session and met study criteria for treatment adherence. Active research staff outreach promoted engagement and retention in the trial. Treatment satisfaction was rated as very good. In both observed and multiple imputation results, women who received mCBT demonstrated greater improvement in depressed mood than those in TAU at 16-week post-randomization and 3-month follow-up, Cohen's d = -0.71 (95% CI -4.93, -5.70). Modified CBT offers promise as a feasible and acceptable treatment for perinatal women with low-incomes in prenatal care settings. Targeted delivery and content modifications are needed to engage populations tailored to setting and psychosocial challenges specific to the perinatal period. © 2013 Wiley Periodicals, Inc.

Effect of tailoring in an internet-based intervention for smoking cessation: randomized controlled trial.

PubMed

Wangberg, Silje C; Nilsen, Olav; Antypas, Konstantinos; Gram, Inger Torhild

2011-12-15

Studies suggest that tailored materials are superior to nontailored materials in supporting health behavioral change. Several trials on tailored Internet-based interventions for smoking cessation have shown good effects. There have, however, been few attempts to isolate the effect of the tailoring component of an Internet-based intervention for smoking cessation and to compare it with the effectiveness of the other components. The study aim was to isolate the effect of tailored emails in an Internet-based intervention for smoking cessation by comparing two versions of the intervention, with and without tailored content. We conducted a two-arm, randomized controlled trial of the open and free Norwegian 12-month follow-up, fully automated Internet-based intervention for smoking cessation, slutta.no. We collected information online on demographics, smoking, self-efficacy, use of the website, and participant evaluation at enrollment and subsequently at 1, 3, and 12 months. Altogether, 2298 self-selected participants aged 16 years or older registered at the website between August 15, 2006 and December 7, 2007 and were randomly assigned to either a multicomponent, nontailored Internet-based intervention for smoking cessation (control) or a version of the same Internet-based intervention with tailored content delivered on the website and via email. Of the randomly assigned participants, 116 (of 419, response rate = 27.7%) in the intervention group and 128 (of 428, response rate = 29.9%) in the control group had participated over the 12 months and responded at the end of follow-up. The 7-day intention-to-treat abstinence rate at 1 month was 15.2% (149/982) among those receiving the tailored intervention, compared with 9.4% (94/999) among those who received the nontailored intervention (P < .001). The corresponding figures at 3 months were 13.5% (122/902) and 9.4% (84/896, P =.006) and at 12 months were 11.2% (47/419) and 11.7% (50/428, P = .91). Likewise, the intervention group had higher self-efficacy and perceived tailoring at 1 and 3 months. Self-efficacy was found to partially mediate the effect of the intervention. Tailoring an Internet-based intervention for smoking cessation seems to increase the success rates in the short term, but not in the long term.

A randomized, double-blind, placebo- controlled study on the anti-haemostatic effects of Curcuma longa, Angelica sinensis and Panax ginseng.

PubMed

Fung, Foon Yin; Wong, Wan Hui; Ang, Seng Kok; Koh, Hwee Ling; Kun, Mei Ching; Lee, Lai Heng; Li, Xiaomei; Ng, Heng Joo; Tan, Chuen Wen; Zhao, Yan; Linn, Yeh Ching

2017-08-15

Herbs with "blood-activating" properties by traditional medicine theory often raise concerns for their possible anti-platelet or anticoagulation effects based on reports from in vitro studies. Such herbs have been implicated for bleeding manifestations based on only anecdotal reports. In particular, the combination of such herbs with anti-platelet agents is often empirically advised against despite lack of good clinical evidence. Here we studied 3 commonly used herbal preparations Curcuma longa, Angelica sinensis and Panax ginseng on their respective anti-platelet and anticoagulation effect, alone and in combination with aspirin. This is a randomized, double-blind, placebo-controlled trial involving 25 healthy volunteers for each herbal preparation. Each subject underwent 3 phases comprising of herbal product alone, aspirin alone and aspirin with herbal product, where each phase lasted for 3 weeks with 2 weeks of washout between phases. PT/APTT, platelet function by light transmission aggregometry and thrombin generation assay by calibrated automated thrombogram were measured at baseline and after each phase. Information on adverse reaction including bleeding manifestations was collected after each phase. On the whole there was no clinically relevant impact on platelet and coagulation function. With the exception of 5 of 24 subjects in the Curcuma longa group, 2 of 24 subjects in the Angelica sinensis group and 1 of 23 subjects in the Panax ginseng group who had an inhibition in arachidonic-acid induced platelet aggregation, there was no effect of these 3 herbals products on platelet aggregation by other agonists. Combination of these herbal products with aspirin respectively did not further aggravate platelet inhibition caused by aspirin. None of the herbs impaired PT/APTT or thrombin generation. There was no significant bleeding manifestation. This study on healthy volunteers provides good evidence on the lack of bleeding risks of Curcuma longa, Angelica sinensis and Panax ginseng either used alone or in combination with aspirin. Copyright © 2017 Elsevier GmbH. All rights reserved.

Aspects of Endowment: A Query Theory of Value Construction

ERIC Educational Resources Information Center

Johnson, Eric J.; Haubl, Gerald; Keinan, Anat

2007-01-01

How do people judge the monetary value of objects? One clue is provided by the typical endowment study (D. Kahneman, J. L. Knetsch, & R. H. Thaler, 1991), in which participants are randomly given either a good, such as a coffee mug, that they may later sell ("sellers") or a choice between the good and amounts of cash ("choosers"). Sellers…

A Monte Carlo Investigation of Conjoint Analysis Index-of-Fit: Goodness of Fit, Significance and Power.

ERIC Educational Resources Information Center

Umesh, U. N.; Mishra, Sanjay

1990-01-01

Major issues related to index-of-fit conjoint analysis were addressed in this simulation study. Goals were to develop goodness-of-fit criteria for conjoint analysis; develop tests to determine the significance of conjoint analysis results; and calculate the power of the test of the null hypothesis of random data distribution. (SLD)

A randomized trial of a low-dose Rasagiline and Pramipexole combination (P2B001) in early Parkinson's disease.

PubMed

Olanow, C Warren; Kieburtz, Karl; Leinonen, Mika; Elmer, Lawrence; Giladi, Nir; Hauser, Robert A; Klepiskaya, Olga S; Kreitzman, David L; Lew, Mark F; Russell, David S; Kadosh, Shaul; Litman, Pninit; Friedman, Hadas; Linvah, Nurit; The P B Study Group, For

2017-05-01

Rasagiline and pramipexole act to improve striatal dopaminergic transmission in PD via distinct and potentially synergistic mechanisms. We performed a placebo-controlled study to determine whether 2 doses of a novel slow-release, low-dose combination of rasagiline and pramipexole (P2B001) are effective and have a good safety profile in patients with early untreated PD. Previously untreated patients with early PD were randomized (1:1:1) to once-daily treatment with P2B001 (0.3 mg pramipexole/0.75 mg rasagiline), P2B001 (0.6 mg pramipexole/0.75 mg rasagiline) or placebo in a 12-week multicenter double-blind, placebo-controlled trial. The primary endpoint was the change from baseline to final visit in Total-UPDRS score versus placebo. Secondary measures included responder analyses of patients achieving ≥4 UPDRS point reduction, and changes in Parkinson Disease Quality of Life Scale-39 and UPDRS activities of daily living and motor scores. A total of 149 participants were randomized and 136 (91.3%) completed the study. Adjusted mean change from baseline to final visit versus placebo in Total-UPDRS score was -4.67 ± 1.28 points for the P2B001 0.6/0.75 mg group (P = .0004) and -3.84 ± 1.25 points for the 0.3/0.75 mg group (P = .003). Significant benefits were also observed for both doses in the responder analysis (P = .0002 and P = .0001), Parkinson Disease Quality of Life Scale-39 scores (P = .05 and P = .01), and the UPDRS motor (P = .02 and P = .006) and activities of daily living (P = .005 and P = .0004) subscores. Adverse events of P2B001 were comparable to placebo apart from transient nausea and somnolence, which were more common with P2B001 treatment. P2B001 offers a promising treatment option for patients with early PD with good clinical efficacy and a low risk of adverse events. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

Effects of Subsidies and Prohibitions on Nutrition in a Food Benefit Program: A Randomized Clinical Trial.

PubMed

Harnack, Lisa; Oakes, J Michael; Elbel, Brian; Beatty, Timothy; Rydell, Sarah; French, Simone

2016-11-01

Strategies to improve the nutritional status of those participating in the Supplemental Nutrition Assistance Program (SNAP) are of interest to policymakers. To evaluate whether the proposed policy of incentivizing the purchase of fruits and vegetables and prohibiting the purchase of less nutritious foods in a food benefit program improves the nutritional quality of participants' diets. Lower income participants (n = 279) not currently enrolled in SNAP were randomized to 1 of 4 experimental financial food benefit conditions: (1) incentive (30% financial incentive for fruits and vegetables purchased using food benefits); (2) restriction (not allowed to buy sugar sweetened beverages, sweet baked goods, or candies with food benefits); (3) incentive plus restriction (30% financial incentive on fruits and vegetables and restriction of purchase of sugar sweetened beverages, sweet baked goods, or candy with food benefits); or (4) control (no incentive or restrictions on foods purchased with food benefits). Participants in all conditions were given a study-specific debit card where funds were added every 4 weeks for a 12-week period. Outcome measures were collected at baseline and in the final 4 weeks of the experimental period. Primary outcomes (from 24-hour dietary recalls) included intake of energy, discretionary calories, and overall diet quality. A number of favorable changes were observed in the incentive plus restriction condition that were significantly different from changes in the control condition. These included (1) reduced intake of energy (-96 kcal/d, standard error [SE], 59.9); (2) reduced intake of discretionary calories (-64 kcal/d, SE 26.3); (3) reduced intake of sugar sweetened beverages, sweet baked goods, and candies (-0.6 servings/d, SE 0.2); (4) increased intake of solid fruit (0.2 servings/d, SE 0.1); and (5) improved Healthy Eating Index score (4.1 points, SE 1.4). Fewer improvements were observed in the incentive only and restriction only arms. A food benefit program that pairs incentives for purchasing more fruits and vegetables with restrictions on the purchase of less nutritious foods may reduce energy intake and improve the nutritional quality of the diet of participants compared with a program that does not include incentives or restrictions. clinicaltrials.gov Identifier: NCT02643576.

A short history of randomized experiments in criminology. A meager feast.

PubMed

Farrington, David P

2003-06-01

This article discusses advantages of randomized experiments and key issues raised in the following articles. The main concern is the growth and decrease in the use of randomized experiments by the California Youth Authority, the U.S. National Institute of Justice, and the British Home Office, although other experiments are also discussed. It is concluded that feast and famine periods are influenced by key individuals. It is recommended that policy makers, practitioners, funders, the mass media, and the general public need better education in research quality so that they can tell the difference between good and poor evaluation studies. They might then demand better evaluations using randomized experiments.

Biodegradable screw versus a press-fit bone plug fixation for hamstring anterior cruciate ligament reconstruction: a prospective randomized study.

PubMed

Jagodzinski, Michael; Geiges, Bjoern; von Falck, Christian; Knobloch, Karsten; Haasper, Carl; Brand, Juergen; Hankemeier, Stefan; Krettek, Christian; Meller, Rupert

2010-03-01

Press-fit fixation of a tendon graft has been advocated to achieve tendon-to-bone healing. Fixation of hamstring tendon grafts with a porous bone scaffold limits bone tunnel enlargement compared with a biodegradable interference screw fixation. Randomized controlled trial; Level of evidence, 1. Methods Between 2005 and 2006, 20 patients (17 men, 3 women) with a primary reconstruction of the anterior cruciate ligament (ACL) were enrolled in this study. Patients were randomized to obtain graft fixation in the tibial tunnel either by means of an interference screw (I) or a press-fit fixation with a porous bone cylinder (P). At 3 months after surgery, a computed tomography (CT) scan of the knee was performed, and tunnel enlargement was analyzed in the coronal and sagittal planes for the proximal, middle, and distal thirds of the tunnel. After 6 months and 1 and 2 years, radiographs of the knee in the sagittal and coronal plane were analyzed for bone tunnel widening. The International Knee Documentation Committee (IKDC), Tegner, and Lysholm scores of both groups were compared after 1 and 2 years. The bone tunnel enlargement determined by CT was 106.9% + or - 10.9% for group P and 121.9% + or - 9.0% for group I (P < .02) in the anteroposterior (AP) plane and 102.8% + or - 15.2% versus 121.5% + or - 10.1% in the coronal plane (P <.01). The IKDC, Tegner, and Lysholm scores improved in both groups from preoperatively to postoperatively without significant differences between the 2 groups. There was a trend to higher knee stability in group P after 3 months (0.6 + or - 1.4 mm vs 1.8 + or - 1.5 mm; P = .08). Both interference screw and a press-fit fixation lead to a high number of good or very good outcomes after ACL reconstruction. Tibial press-fit fixation decreases the amount of proximal bone tunnel enlargement.

CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration

PubMed Central

Hopewell, Sally; Clarke, Mike; Moher, David; Wager, Elizabeth; Middleton, Philippa; Altman, Douglas G; Schulz, Kenneth F

2008-01-01

Background Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract. Methods and Findings We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item. Conclusions CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results. PMID:18215107

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

The effect of instruction in analgesic use compared with neuromuscular exercise on knee-joint load in patients with knee osteoarthritis: a randomized, single-blind, controlled trial.

PubMed

Holsgaard-Larsen, A; Clausen, B; Søndergaard, J; Christensen, R; Andriacchi, T P; Roos, E M

2017-04-01

To investigate the effect of a neuro-muscular exercise (NEMEX) therapy program compared with instructions in optimized analgesics and anti-inflammatory drug use (PHARMA), on measures of knee-joint load in people with mild to moderate knee osteoarthritis (OA). We hypothesized that knee joint loading during walking would be reduced by NEMEX and potentially increased by PHARMA. Single-blind, randomized controlled trial (RCT) comparing NEMEX therapy twice a week with PHARMA. Participants with mild-to-moderate medial tibiofemoral knee OA were randomly allocated (1:1) to one of two 8-week treatments. Primary outcome was change in knee load during walking (Knee Index, a composite score from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes were frontal plane peak knee adduction moment (KAM), Knee Injury and Osteoarthritis Outcome Scores (KOOS) and functional performance tests. Ninety three participants (57% women, 58 ± 8 years with a body mass index [BMI] of 27 ± 4 kg/m 2 (mean ± standard deviation [SD])) were randomized to NEMEX group (n = 47) or PHARMA (n = 46); data from 44 (94%) and 41 (89%) participants respectively, were available at follow-up. 49% of the participants in NEMEX and only 7% in PHARMA demonstrated good compliance. We found no difference in the primary outcome as evaluated by the Knee Index -0.07 [-0.17; 0.04] Nm/%BW HT. Secondary outcomes largely supported this finding. We found no difference in the primary outcome; knee joint load change during walking from a NEMEX program vs information on the recommended use of analgesics and anti-inflammatory drugs. ClinicalTrials.gov Identifier: NCT01638962 (July 3, 2012). Ethical Committee: S-20110153. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

[CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration].

PubMed

Hopewel, Sally; Clarke, Mike; Moher, David; Wager, Elizabeth; Middleton, Philippa; Altman, Douglas G; Schulz, Kenneth F; The, Consort Group

2008-03-01

Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract. We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item. CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.

Research protocol for a randomized controlled trial of the health effects of volunteering for seniors.

PubMed

Pettigrew, Simone; Jongenelis, Michelle; Newton, Robert U; Warburton, Jeni; Jackson, Ben

2015-06-04

A growing evidence base demonstrates that interventions that focus on participation in physical and social activities can assist in preventing and treating both physical and mental health problems. In addition, there is some evidence that engaging in volunteering activities can provide beneficial social, physical, psychological, and cognitive outcomes for older people. This study will use a randomized controlled trial approach to investigate the potential for interventions involving volunteer activities to produce positive physical and psychological outcomes for older people, thereby contributing to the limited evidence relating to the potential for volunteering to provide multiple health effects. This randomized controlled trial will involve 400 retired/non-employed individuals in good health aged 60+ years living in the metropolitan area in Perth, Western Australia. Participants will be recruited from the Perth metropolitan area using a variety of recruitment methods to achieve a diverse sample in terms of age, gender, and socioeconomic status. Consenting and eligible participants will be randomly assigned to an intervention (n = 200) or control group (n = 200). Those in the intervention group will be asked to engage in a minimum 60 min of volunteer activities per week for a period of 6 months, while those in the control group will be asked to maintain their existing lifestyle or take on new activities as they see fit. Physical and psychological outcomes will be assessed. Primary physical outcomes will include physical activity and sedentary time (measured using pedometers and Actigraph monitors) and physical health (measured using a battery of physical functioning tests, resting heart rate, blood pressure, BMI, and girth). Primary psychological outcomes will include psychological well-being, depression, self-esteem, and quality of life (measured using the Warwick-Edinburgh Mental Well-Being Scale, Center for Epidemiologic Studies Depression Scale, the Rosenberg Self-Esteem Survey, and the Global Quality of Life Scale, respectively). Secondary outcomes of interest will include attitudes to volunteering (measured via open-ended interviews) and personal growth, purpose in life, social support, and self-efficacy (measured using the Personal Growth and Purpose in Life subscales of Ryff's Psychological Well-Being Scale, the Social Provisions Scale, and the Generalized Self-Efficacy Scale, respectively). Participants will be re-assessed on these measures after 6 months. The results of this randomized controlled trial will generate new knowledge relating to the physical and psychological health benefits of different levels and types of volunteering for older people. In addition, insight will be provided into the major factors influencing the recruitment and retention of older volunteers. Understanding the full potential for volunteering to affect physical and mental well-being will provide policy makers with the evidence they require to determine appropriate investment in the volunteering sector, especially in relation to encouraging volunteering among older people who constitute an important resource for the community. Australian and New Zealand Clinical Trials Registry ACTRN12615000091505. Date registered: 3 February, 2015.

Examining the controllability of sepsis using genetic algorithms on an agent-based model of systemic inflammation.

PubMed

Cockrell, Robert Chase; An, Gary

2018-02-01

Sepsis, a manifestation of the body's inflammatory response to injury and infection, has a mortality rate of between 28%-50% and affects approximately 1 million patients annually in the United States. Currently, there are no therapies targeting the cellular/molecular processes driving sepsis that have demonstrated the ability to control this disease process in the clinical setting. We propose that this is in great part due to the considerable heterogeneity of the clinical trajectories that constitute clinical "sepsis," and that determining how this system can be controlled back into a state of health requires the application of concepts drawn from the field of dynamical systems. In this work, we consider the human immune system to be a random dynamical system, and investigate its potential controllability using an agent-based model of the innate immune response (the Innate Immune Response ABM or IIRABM) as a surrogate, proxy system. Simulation experiments with the IIRABM provide an explanation as to why single/limited cytokine perturbations at a single, or small number of, time points is unlikely to significantly improve the mortality rate of sepsis. We then use genetic algorithms (GA) to explore and characterize multi-targeted control strategies for the random dynamical immune system that guide it from a persistent, non-recovering inflammatory state (functionally equivalent to the clinical states of systemic inflammatory response syndrome (SIRS) or sepsis) to a state of health. We train the GA on a single parameter set with multiple stochastic replicates, and show that while the calculated results show good generalizability, more advanced strategies are needed to achieve the goal of adaptive personalized medicine. This work evaluating the extent of interventions needed to control a simplified surrogate model of sepsis provides insight into the scope of the clinical challenge, and can serve as a guide on the path towards true "precision control" of sepsis.

Characterization of Albendazole-Randomly Methylated-β-Cyclodextrin Inclusion Complex and In Vivo Evaluation of Its Antihelmitic Activity in a Murine Model of Trichinellosis

PubMed Central

García, Agustina; Leonardi, Darío; Vasconi, María D.; Hinrichsen, Lucila I.; Lamas, María C.

2014-01-01

Albendazole is a benzimidazole carbamate extensively used in oral chemotherapy against intestinal parasites, due to its broad spectrum activity, good tolerance and low cost. However, the drug has the disadvantage of poor bioavailability due to its very low solubility in water; as a consequence, a very active area of research focuses on the development of new pharmaceutical formulations to increase its solubility, dissolution rate, and bioavailability. The primary objective of this study was to prepare randomly methylated β-cyclodextrins inclusion complexes to increase albendazole dissolution rate, in order to enhance its antiparasitic activity. This formulation therapeutic efficacy was contrasted with that of the pure drug by treating Trichinella spiralis infected mice during the intestinal phase of the parasite cycle, on days five and six post-infection. This protocol significantly decreased muscle larval burden measured in the parenteral stage on day 30 post-infection, when compared with the untreated control. Thus, it could be demonstrated that the inclusion complexes improve the in vivo therapeutic activity of albendazole. PMID:25406084

Impact of preoperative patient education on the prevention of postoperative complications after major visceral surgery: the cluster randomized controlled PEDUCAT trial.

PubMed

Klaiber, Ulla; Stephan-Paulsen, Lisa M; Bruckner, Thomas; Müller, Gisela; Auer, Silke; Farrenkopf, Ingrid; Fink, Christine; Dörr-Harim, Colette; Diener, Markus K; Büchler, Markus W; Knebel, Phillip

2018-05-24

The prevention of postoperative complications is of prime importance after complex elective abdominal operations. Preoperative patient education may prevent postoperative complications and improve patients' wellbeing, but evidence for its efficacy is poor. The aims of the PEDUCAT trial were (a) to assess the impact of preoperative patient education on postoperative complications and patient-reported outcomes in patients scheduled for elective complex visceral surgery and (b) to evaluate the feasibility of cluster randomization in this setting. Adult patients (age ≥ 18 years) scheduled for elective major visceral surgery were randomly assigned in clusters to attend a preoperative education seminar or to the control group receiving the department's standard care. Outcome measures were the postoperative complications pneumonia, deep vein thrombosis (DVT), pulmonary embolism, burst abdomen, and in-hospital fall, together with patient-reported outcomes (postoperative pain, anxiety and depression, patient satisfaction, quality of life), length of hospital stay (LOS), and postoperative mortality within 30 days after the index operation. Statistical analysis was primarily by intention to treat. In total 244 patients (60 clusters) were finally included (intervention group 138 patients; control group 106 patients). Allocation of hospital wards instead of individual patients facilitated study conduct and reduced confusion about group assignment. In the intervention and control groups respectively, pneumonia occurred in 7.4% versus 8.3% (p = 0.807), pulmonary embolism in 1.6% versus 1.0% (p = 0.707), burst abdomen in 4.2% versus 1.0% (p = 0.165), and in-hospital falls in 0.0% versus 4.2% of patients (p = 0.024). DVT did not occur in any of the patients. Mortality rates (1.4% versus 1.9%, p = 0.790) and LOS (14.2 (+/- 12.0) days versus 16.1 (+/- 15.0) days, p = 0.285) were also similar in the intervention and control groups. Cluster randomization was feasible in the setting of preoperative patient education and reduced the risk of contamination effects. The results of this trial indicate good postoperative outcomes in patients undergoing major visceral surgery without superiority of preoperative patient education compared to standard patient care at a high-volume center. However, preoperative patient education is a helpful instrument not only for teaching patients but also for training the nursing staff. German Clinical Trials Registry, DRKS00004226 . Registered on 23 October 2012. Registered 8 days after the first enrollment.

Medical treatment for botulism.

PubMed

Chalk, Colin; Benstead, Tim J; Keezer, Mark

2011-03-16

Botulism is an acute paralytic illness caused by a neurotoxin produced by Clostridium botulinum. Supportive care, including intensive care, is key but the role of other medical treatments is unclear. To assess the effects of medical treatments on mortality, duration of hospitalization, mechanical ventilation, tube or parenteral feeding and risk of adverse events in botulism. We searched the Cochrane Neuromuscular Disease Group Specialized Register (10 January 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (10 January 2010 in The Cochrane Library, Issue 4 2010), MEDLINE (January 1966 to January 2011) and EMBASE (January 1980 to January 2011). We reviewed bibliographies, and contacted authors and experts. We included randomized and quasi-randomized controlled trials examining the medical treatment of any of the four major types of botulism (infant intestinal botulism, food-borne botulism, wound botulism and adult intestinal toxemia). Medical treatments included equine serum trivalent botulism antitoxin, human-derived botulinum immune globulin, plasma exchange, 3,4-diaminopyridine and guanidine. Two authors selected studies, assessed risk of bias and extracted data independently onto data extraction forms.Our primary outcome was in-hospital death from any cause occurring within four weeks. Secondary outcomes were death occurring within 12 weeks, duration of hospitalization, mechanical ventilation, tube or parenteral feeding and risk of adverse events. A single randomized controlled trial met the inclusion criteria. This trial evaluated human-derived botulinum immune globulin for the treatment of infant botulism. This study included 59 treatment patients and 63 control patients. There were no deaths in either group making any treatment effect on mortality inestimable. There was a significant benefit in the treatment group on duration of hospitalization (mean difference (MD) 3.10 weeks, 95% confidence interval (CI) 1.68 to 4.52), mechanical ventilation (MD 2.60 weeks, 95% CI 1.14 to 4.06), and tube or parenteral feeding (MD 6.40 weeks, 95% CI 2.80 to 10.00) but not on risk of adverse events or complications (relative risk reduction 0.92, 95% CI 0.72 to 1.18; absolute risk reduction 0.06, 95% CI 0.22 to -0.11). There is good evidence supporting the use of human-derived botulinum immune globulin in infant intestinal botulism. A single randomized controlled trial demonstrated significant decreases in the duration of hospitalization, mechanical ventilation and tube or parenteral feeding among treated patients. Our search did not reveal any evidence examining the use of other medical treatments including serum trivalent botulism antitoxin.

Resource-oriented coaching for reduction of examination-related stress in medical students: an exploratory randomized controlled trial.

PubMed

Kötter, Thomas; Niebuhr, Frank

2016-01-01

The years spent in acquiring medical education is considered a stressful period in the life of many students. Students whose mental health deteriorates during this long period of study are less likely to become empathic and productive physicians. In addition to other specific stressors, academic examinations seem to further induce medical school-related stress and anxiety. Combined group and individual resource-oriented coaching early in medical education might reduce examination-related stress and anxiety and, consequently, enhance academic performance. Good quality evidence, however, remains scarce. In this study, therefore, we explored the question of whether coaching affects examination-related stress and health in medical students. We conducted a randomized controlled trial. Students who registered for the first medical academic examination in August 2014 at the University of Lübeck were recruited and randomized into three groups. The intervention groups 1 and 2 received a 1-hour psychoeducative seminar. Group 1 additionally received two 1-hour sessions of individual coaching during examination preparation. Group 3 served as a control group. We compared changes in self-rated general health (measured by a single item), anxiety and depression (measured by the hospital anxiety and depression scale), as well as medical school stress (measured by the perceived medical school stress instrument). In order to further investigate the influence of group allocation on perceived medical school stress, we conducted a linear regression analysis. We saw a significant deterioration of general health and an increase in anxiety and depression scores in medical students while preparing for an examination. We found a small, but statistically significant, effect of group allocation on the development of perceived medical school stress. However, we could not differentiate between the effects of group coaching only and group coaching in combination with two sessions of individual coaching. The health of medical students deteriorated while preparing for an examination. Short-term resource-oriented coaching might be an effective means of reducing medical school stress in candidates preparing for an examination.

A Decision Aid to Promote Appropriate Colorectal Cancer Screening among Older Adults: A Randomized Controlled Trial.

PubMed

Lewis, Carmen L; Kistler, Christine E; Dalton, Alexandra F; Morris, Carolyn; Ferrari, Renée; Barclay, Colleen; Brewer, Noel T; Dolor, Rowena; Harris, Russell; Vu, Maihan; Golin, Carol E

2018-07-01

Concerns have been raised about both over- and underutilization of colorectal cancer (CRC) screening in older patients and the need to align screening behavior with likelihood of net benefit. The purpose of this study was to test a novel use of a patient decision aid (PtDA) to promote appropriate CRC screening in older adults. A total of 424 patients ages 70 to 84 y who were not up to date with CRC screening participated in a double-blinded randomized controlled trial of a PtDA targeted to older adults making decisions about whether to undergo CRC screening from March 2012 to February 2015. Patients were randomized to a targeted PtDA or an attention control. The PtDA was designed to facilitate individualized decision making-helping patients understand the potential risks, benefits, and uncertainties of CRC screening given advanced age, health state, preferences, and values. Two composite outcomes, appropriate CRC screening behavior 6 mo after the index visit and appropriate screening intent immediately after the visit, were defined as completed screening or intent for patients in good health, discussion about screening with their provider for patients in intermediate health, and no screening or intent for patients in poor health. Health state was determined by age and Charlson Comorbidity Index. Four hundred twelve (97%) and 421 (99%) patients were analyzed for the primary and secondary outcomes, respectively. Appropriate screening behavior at 6 mo was higher in the intervention group (55% v. 45%, P = 0.023) as was appropriate screening intent following the provider visit (61% v. 47%, P = 0.003). The study took place in a single geographic region. The appropriate CRC screening classification system used in this study has not been formally validated. A PtDA for older adults promoted appropriate CRC screening behavior and intent. Clinicaltrials.gov, registration number NCT01575990. https://clinicaltrials.gov/ct2/show/NCT01575990?term=epic-d&rank=1.

Effect of whole soy and purified isoflavone daidzein on renal function--a 6-month randomized controlled trial in equol-producing postmenopausal women with prehypertension.

PubMed

Liu, Zhao-min; Ho, Suzanne C; Chen, Yu-ming; Tang, Nelson; Woo, Jean

2014-09-01

The aim of the study was to examine the long-term effect of commonly used whole soy foods (soy flour) and purified daidzein (one major isoflavone and the precursor of equol) on renal function among prehypertensive postmenopausal women who are also equol producers, a population most likely to benefit from soy intervention. This was a 6-month double-blind, randomized, placebo-controlled trial. Two hundred seventy eligible Chinese women were randomized to either one of the three treatments: 40 g soy flour (whole soy group), 40 g low-fat milk powder + 63 mg daidzein (daidzein group) or 40 g low-fat milk powder (placebo group) daily each for 6 months. Fasting blood and 24-h urine samples were collected at the beginning and end of trial. Serum creatinine, cystatin C, urea, angiotensin-converting enzyme, minerals and 24-h urinary creatinine and minerals were analyzed. Estimated glomerular filtration rate (eGFR) was calculated with the Cockcroft-Gault and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations. Two hundred fifty-three subjects completed the study according to the protocol. Urinary isoflavones indicated good compliance of participants. No significant changes were observed in most of renal parameters, however, there was a less decrease in eGFRcockcroft in 6-month change (p=0.044) and %change (p=0.031) with whole soy intake relative to milk placebo. Subgroup analysis among women with lowered renal function suggested whole soy consumption tended to improve markers of renal function relative to control. Six-month consumption of whole soy tended to have a modest improvement of renal function in prehypertensive postmenopausal women with lowered renal function. Future trials in subjects with more declined renal function are necessary. The trial was registered in ClinicalTrials.gov with identifier of NCT01270737. (URL: http://clinicaltrials.gov/ct2/show/NCT01270737). Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Hyperbaric Oxygen Therapy Can Improve Post Concussion Syndrome Years after Mild Traumatic Brain Injury - Randomized Prospective Trial

PubMed Central

Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

2013-01-01

Background Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. Methods and Findings The trial population included 56 mTBI patients 1–5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. “Mindstreams” was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. Conclusions HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. Trial Registration ClinicalTrials.gov NCT00715052 PMID:24260334

Coherent light scattering of heterogeneous randomly rough films and effective medium in the theory of electromagnetic wave multiple scattering

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

Berginc, G

2013-11-30

We have developed a general formalism based on Green's functions to calculate the coherent electromagnetic field scattered by a random medium with rough boundaries. The approximate expression derived makes it possible to determine the effective permittivity, which is generalised for a layer of an inhomogeneous random medium with different types of particles and bounded with randomly rough interfaces. This effective permittivity describes the coherent propagation of an electromagnetic wave in a random medium with randomly rough boundaries. We have obtained an expression, which contains the Maxwell – Garnett formula at the low-frequency limit, and the Keller formula; the latter hasmore » been proved to be in good agreement with experiments for particles whose dimensions are larger than a wavelength. (coherent light scattering)« less

A Randomized Controlled Trial of the Group-Based Modified Story Memory Technique in TBI

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-16-1-0726 TITLE: A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI PRINCIPAL...2017 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI 5b. GRANT...forthcoming, The current study addresses this need through a double blind, placebo- controlled , randomized clinical trial (RCT) of a group

Endoscopic Evacuation of Basal Ganglia Hemorrhage via Keyhole Approach Using an Adjustable Cannula in Comparison with Craniotomy

PubMed Central

Zhang, Heng-Zhu; Li, Yu-Ping; Yan, Zheng-cun; Wang, Xing-dong; She, Lei; Wang, Xiao-dong; Dong, Lun

2014-01-01

Neuroendoscopic (NE) surgery as a minimal invasive treatment for basal ganglia hemorrhage is a promising approach. The present study aims to evaluate the efficacy and safety of NE approach using an adjustable cannula to treat basal ganglia hemorrhage. In this study, we analysed the clinical and radiographic outcomes between NE group (21 cases) and craniotomy group (30 cases). The results indicated that NE surgery might be an effective and safe approach for basal ganglia haemorrhage, and it is also suggested that NE approach may improve good functional recovery. However, NE approach only suits the selected patient, and the usefulness of NE approach needs further randomized controlled trials (RCTs) to evaluate. PMID:24949476

Xylitol lozenges were not effective in overall dental caries prevention in adults.

PubMed

Fontana, Margherita; Gonzalez-Cabezas, Carlos

2013-09-01

Results from the xylitol for adult caries trial (X-ACT). Bader JD, Vollmer WM, Shugars DA, Gilbert GH, Amaechi BT, Brown JP, Laws RL, Kunkhouser KA, Makhija SK, Ritter AV, Leo MC. JADA 2013; 144(1): 21-30. Margherita Fontana, DDS, PhD, Carlos Gonzalez-Cabezas, DDS, MSD, PhD PURPOSE/QUESTION: Among an adult population at risk of dental caries, does the use of five 1 g xylitol lozenges per day over 33 months reduce the experience of cavitated caries lesions? Government: National Institute of Dental and Craniofacial Research Multicenter, double blind, placebo-controlled, randomized clinical trial Level 1: Good quality, patient-oriented evidence B: Limited quality patient-oriented evidence. Published by Mosby, Inc.

Survey of Obstetrician-Gynecologists about Giardiasis

PubMed Central

Krueger, Amy; Schulkin, Jay; L. Jones, Jeffrey

2007-01-01

Giardiasis is one of the most common parasitic diseases in the United States with over 15 400 cases reported in 2005. A survey was conducted by The American College of Obstetricians and Gynecologists (ACOG) in collaboration with the Centers for Disease Control and Prevention (CDC) to evaluate the knowledge of obstetricians and gynecologists regarding the diagnosis and treatment of giardiasis. The questionnaire was distributed to a random sample of 1200 ACOG fellows during February through June of 2006. Five hundred and two (42%) responded to the survey. The respondents showed good general knowledge about diagnosis, transmission, and prevention; however, there was some uncertainty about the treatment of giardiasis and which medications are the safest to administer during the first trimester of pregnancy. PMID:17710238

The balance principle in scientific research.

PubMed

Hu, Liang-ping; Bao, Xiao-lei; Wang, Qi

2012-05-01

The principles of balance, randomization, control and repetition, which are closely related, constitute the four principles of scientific research. The balance principle is the kernel of the four principles which runs through the other three. However, in scientific research, the balance principle is always overlooked. If the balance principle is not well performed, the research conclusion is easy to be denied, which may lead to the failure of the whole research. Therefore, it is essential to have a good command of the balance principle in scientific research. This article stresses the definition and function of the balance principle, the strategies and detailed measures to improve balance in scientific research, and the analysis of the common mistakes involving the use of the balance principle in scientific research.

Are Locking Constructs in Distal Femoral Fractures Always Best? A Prospective Multicenter Randomized Controlled Trial Comparing the Less Invasive Stabilization System With the Minimally Invasive Dynamic Condylar Screw System.

PubMed

2016-01-01

The purpose of this clinical study is to determine whether the rate of fracture healing and fracture union, repaired with a locked device, will be as good as or better than standard nonlocking bicortical fixation in distal femoral fractures. Institutional review board-approved, multicenter prospective randomized controlled trial. Seven level 1 trauma centers across Canada. Fifty-two patients with distal femoral fractures (AO/OTA 33A1 to 33C2) were enrolled in the randomized trial. Twelve AO/OTA 33C3 fractures were excluded from the randomized trial but followed up as a nonrandomized cohort. Patients were treated through a standardized minimally invasive approach. Fractures were randomized 1:1 to treatment with the locked Less Invasive Stabilization System (LISS; Synthes, Paoli, PA) or the dynamic condylar screw (DCS). The nonrandomized cohort was treated at the surgeon's discretion. Primary outcomes were time to radiological union and number of delayed/nonunions at 12 months. Secondary outcomes were postoperative function and complications. Fifty-two patients were randomized including 34 women and 18 men. The mean age was 59 years. Twenty-eight patients were treated with the LISS and 24 with the DCS. There was no statistically significant difference between the LISS and the DCS in terms of the number of fractures healed, time to union, or functional scores. Complications and revisions were more common in the LISS group. There were 7 reoperations in the LISS group and one in the DCS group. Only 52% of the LISS group healed without intervention by 12 months compared with 91% in the DCS group. There was no advantage to the locking plate design in the management of distal femoral fractures in this study. The higher cost of the locking plates, challenges in technique, and lack of superiority have led the authors to discontinue the use of this lateral unicortical locking device in favor of other devices that allow locked or nonlocked bicortical fixation, articular compression, and bridging of the comminuted fracture segments. The cost-effective treatment for a subgroup or periarticular fractures may be a fixed-angle nonlocked device in patients with reasonable bone quality. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars.

PubMed

Prager, Welf; Gauglitz, Gerd G

2018-06-14

An occlusive overnight intensive patch medical device (OIP) containing onion extract and allantoin has been developed for preventing and treating dermatologic scars and keloids. Here, we examined the efficacy and safety of the OIP for post-dermatologic surgery scars. This was an intra-individual randomized, observer-blind, controlled study in adults with post-dermatologic surgery scars. Two scars per subject were randomized to no treatment or overnight treatment with the OIP for 12-24 weeks. Scar quality was assessed using the Patient and Observer Scar Assessment Scale (POSAS) and a Global Aesthetic Improvement Scale. A total of 125 subjects were included. The decrease in observer-assessed POSAS from baseline was significantly greater for treated than untreated scars at week 6 (p < 0.001) and 24 (p = 0.001). The decrease in patient-assessed POSAS was significantly greater for the treated scar than the untreated scar at week 12 (p = 0.017) and 24 (p = 0.014). Subject- and investigator-evaluated Global Aesthetic Improvement Scale scores were higher for the treated than the untreated scar at all visits. All subjects considered the global comfort of the OIP to be good or very good, and no safety concerns were identified. This study confirmed that the OIP safely promotes scar healing after minor dermatologic surgery. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Efficacy and tolerability of EPs 7630 in children and adolescents with acute bronchitis - a randomized, double-blind, placebo-controlled multicenter trial with a herbal drug preparation from Pelargonium sidoides roots.

PubMed

Kamin, W; Maydannik, V; Malek, F A; Kieser, M

2010-03-01

The study aim was to demonstrate the efficacy and to investigate the tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides roots, in the treatment of patients (1 - 18 years) with acute bronchitis outside the strict indication for antibiotics. A total of 200 patients were randomized to receive either active drug containing EPs 7630 (1 - 6 years: 3 x 10 drops/d; > 6 - 12 years: 3 x 20 drops/d; > 12 - 18 years: 3 x 30 drops/d) or placebo for 7 consecutive days. change in the total score of bronchitis-specific symptoms (BSS) from Day 0 to Day 7. Main secondary outcome measures: treatment outcome, patients' satisfaction with treatment, onset of effect, bed rest. From baseline to Day 7, the mean BSS score improved significantly more for EPs 7630 compared with placebo (3.4 +/- 1.8 vs. 1.2 +/- 1.8 points, p < 0.0001). On Day 7, treatment outcome was significantly better (p < 0.0001), satisfaction with treatment more pronounced (77.6% vs. 25.8%, p < 0.0001), onset of effect faster, and time of bed rest shorter as compared with placebo. Tolerability was similarly good in both groups. All adverse events were assessed as non-serious. EPs 7630 was shown to be efficacious and safe in the treatment of acute bronchitis in children and adolescents outside the strict indication for antibiotics with patients treated with EPs 7630 perceiving a more favorable course of the disease and a good tolerability as compared with placebo.

Efficacy and safety profile evaluation of acarbose alone and in association with other antidiabetic drugs: a systematic review.

PubMed

Derosa, Giuseppe; Maffioli, Pamela

2012-06-01

Epidemiologic studies have revealed that postprandial hyperglycemia significantly contributes to high glycated hemoglobin concentrations and could be linked to the development of chronic diabetic complications. The purpose of our review was to evaluate the clinical efficacy and safety profile of treatment with acarbose alone and combined with other antidiabetic drugs. A systematic search strategy was developed to identify randomized controlled trials included in MEDLINE and the Cochrane Register of Controlled Trials. The terms acarbose, α-glucosidase inhibitors, type 2 diabetes, adverse events, combination therapy, and postprandial glucose were incorporated into an electronic search strategy that included the Dickersin filter for randomized controlled trials. To qualify for inclusion, clinical trials had to be randomized trials comparing treatment with acarbose at any dosage with any other antidiabetic drug in patients with type 2 diabetes mellitus or impaired glucose tolerance. Eligible trials had to present results on glycemic control or adverse events. Trial participants needed to be affected by type 2 diabetes mellitus or have impaired glucose tolerance, and the intervention had to include acarbose at any dosage as monotherapy or combined with other antidiabetic drugs. A validated 3-item scale was used to evaluate the overall reporting quality of the trials selected for inclusion in the present review. Nineteen trials were included. Treatment with acarbose significantly reduced glycated hemoglobin levels when given as monotherapy and as an add-on to other antidiabetic drug treatment (P < 0.0001). Acarbose treatment was effective in patients with uncontrolled type 2 diabetes and in patients with apparently good metabolic control owing to its positive effect on postprandial hyperglycemia (P < 0.0001). Treatment with acarbose seemed to improve the lipid profile (P < 0.05), reduce circulating levels of cell adhesion molecules (P < 0.05), reduce intima-media thickness progression (P = 0.01), and reverse impaired glucose tolerance to normal glucose tolerance (P < 0.0001). When current therapy is not adequate to obtain glycemic control, acarbose could be an option as monotherapy and as an add-on to other antidiabetic drug treatment, especially when postprandial hyperglycemia is the main concern. Long-term studies are needed to determine whether the effects observed with acarbose use are maintained over the years. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Short-Term Effectiveness of Web-Based Guided Self-Help for Phobic Outpatients: Randomized Controlled Trial

PubMed Central

van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

2014-01-01

Background Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. Objective The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. Methods We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. Results At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Conclusions Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in routine outpatient practice. Trial Registration Netherlands Trial Register NTR2233; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2233 (Archived by WebCite at http://www.webcitation.org/6O2ioOQSs). PMID:25266929

Patient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation-a randomized controlled trial.

PubMed

Vide, João; Freitas, Tânia Pinto; Ramos, Acácio; Cruz, Henrique; Sousa, João Paulo

2017-08-01

This randomized controlled trial was conducted to compare patient-specific instrumentation (PSI) to standard instrumentation regarding efficacy to achieve a good coronal alignment and differences in surgical time, blood loss and length of stay. Ninety-five of 100 randomized patients eligible for total knee arthroplasty were analysed. PSI with magnetic resonance and long-leg radiograph was performed in 47 patients, while 48 patients received standard instrumentation. Primary outcome measure was coronal alignment, evaluated with long-leg radiograph. Deviation >3° varus/valgus was considered an outlier. Surgical time was compared from skin to skin. Length of stay was a post hoc analysis. Blood loss was evaluated comparing the number of blood units spent, fall in haemoglobin and haematocrit levels. Standard instrumentation had a higher number of outliers in the coronal alignment with a relative risk of 3.015, compared to PSI. Surgical time was reduced by 18 min (24.8 %) with the PSI, as well as length of stay, with a half-day reduction. Number of blood units spent was significantly less in the PSI group. Relative risk of transfusion was 7.09 for patients in the standard instrumentation group. Difference in Hg and Htc levels were not significant. No patient had to abandon PSI. Minor changes to preoperative plan occurred in 14.9 % of the patient: cut review in 4.3 % and insert change in 10.6 %. Patient-specific instrumentation (PSI) is able to provide important advantages over standard instrumentation in total knee arthroplasty: it lowers the risk of outliers and transfusion, is a faster procedure and enables a shorter length of stay with a low rate of intraoperative adjustments. I.

Effects of Mind-Body Exercises for Mood and Functional Capabilities in Patients with Stroke: An Analytical Review of Randomized Controlled Trials.

PubMed

Zou, Liye; Yeung, Albert; Zeng, Nan; Wang, Chaoyi; Sun, Li; Thomas, Garrett Anthony; Wang, Huiru

2018-04-11

Objective : The effects of stroke are both physical and mental in nature and may have serious implications on the overall well-being of stroke survivors. This analytical review aims to critically evaluate and statistically synthesize the existing literature regarding the effects of mind-body (MB) exercises on mood and functional capabilities in patients with stroke. Methods : A structured literature review was performed in both English (PubMed, PEDro, and Cochrane Library) and Chinese (Wanfang and CNKI (Chinese National Knowledge Information Database)) databases. Sixteen randomized controlled trials were considered eligible for meta-analysis. Based on the random effects model, we used the pooled effect size to determine the magnitude of rehabilitative effect of MB exercise intervention on depression, anxiety, activities of daily living, and functional mobility among stroke survivors. The sum PEDro score ranged from five to nine points (fair-to-good methodological quality), but the absence of concealed allocation and blinded assessors were reported in most studies. Results : The aggregated results showed that MB exercise intervention is associated with significantly improved ADL (Hedges' g = 1.31, 95% CI 0.85 to 1.77, p < 0.001, I ² = 79.82%) and mobility (Hedges' g = 0.67, 95% CI 0.25 to 1.09, p < 0.001, I ² = 69.65%), and reduced depression (Hedges' g = -0.76, 95% CI -1.16 to -0.35, p < 0.001, I ² = 74.84%). Conclusions : as add-on treatments, the MB exercises may potentially improve depression, activities of daily living, and mobility of these post-stroke patients. Future studies with more robust methodology will be needed to provide a more definitive conclusion.

Periconceptional iron supplementation does not reduce anemia or improve iron status among pregnant women in rural Bangladesh.

PubMed

Khambalia, Amina Z; O'Connor, Deborah L; Macarthur, Colin; Dupuis, Annie; Zlotkin, Stanley H

2009-11-01

There is a growing interest in periconceptional iron supplementation in developing countries by researchers and policy makers; however, there are no randomized controlled trials that examine the effectiveness of this strategy in decreasing anemia during pregnancy. The aim was to determine whether periconceptional iron supplementation reduces anemia during pregnancy. A randomized, double-blind, controlled trial was conducted in rural Bangladesh. Married, nulliparous women were randomly assigned to receive daily iron and folic acid (IFA; 60 mg ferrous fumarate and 400 microg folic acid) (n = 134) or folic acid (FA; 400 microg) (n = 138) in the form of a powdered supplement added to food. Women were followed until pregnancy or the end of 9 mo. Primary outcomes included hemoglobin, plasma ferritin, and plasma transferrin receptor concentrations. Among 88 pregnant women, periconceptional IFA in comparison with FA did not affect anemia or iron status at 15 wk gestation. However, each 1% increase in adherence was associated with a 10-g/L increase in change in hemoglobin from baseline (P = 0.03), and those who initiated supplementation at a mean (+/-SD) time of 72.9 +/- 57.8 d before conception showed a 7.3-g/L increase in change in hemoglobin from baseline compared with those who initiated supplementation at 26.3 +/- 12.3 d after conception (P = 0.01). Among 146 nonpregnant women, IFA decreased anemia (odds ratio: 0.19; 95% CI: 0.04, 0.95) and improved iron stores (P = 0.001) more than did FA. Good adherence and initiation of supplementation before conception are needed to reduce anemia during early pregnancy. This trial was registered at www.clinicaltrials.gov as NCT00953134.

Efficacy and safety of methantheline bromide (Vagantin(®) ) in axillary and palmar hyperhidrosis: results from a multicenter, randomized, placebo-controlled trial.

PubMed

Müller, C; Berensmeier, A; Hamm, H; Dirschka, T; Reich, K; Fischer, T; Rzany, B

2013-10-01

Focal hyperhidrosis can severely affect quality of life. So far, knowledge on the effect of systemic therapy of focal hyperhidrosis is limited. To assess the efficacy and safety of methantheline bromide (MB) in the treatment of axillary and palmar-axillary hyperhidrosis. A multicenter controlled randomized double-blind clinical trial was conducted in patients with axillary or palmar-axillary hyperhidrosis defined by a sweat production >50 mg/5 min. Patients received 3 × 50 mg MB daily or placebo over a period of 28 ± 1 days. Main outcome criterion was the reduction of sweat as measured by gravimetry on day 28 ± 1. Quality of life was assessed by Dermatology Life Quality Index (DLQI) and Hyperhidrosis Disease Severity Score (HDSS). A total of 339 patients were randomly assigned to receive MB or placebo. On day 28 ± 1, the mean axillary sweat production was 99 mg for MB and 130 mg for placebo compared with 168 mg and 161 mg respectively at baseline (P = 0.004). Patient's HDSS score decreased in the MB group from 3.2 to 2.4 compared with 3.2 to 2.7 for placebo (P = 0.002). Similar results could be obtained for the DLQI with 9.7 for MB and 12.2 for placebo, which decreased from 16.4 or 17 respectively (P = 0.003). Tolerability was good for both groups. The most frequent adverse event was dry mouth. Fifty milligrams methantheline bromide three times a day is an effective and safe treatment of axillary hyperhidrosis. © 2012 The Authors. Journal of the European Academy of Dermatology and Venereology © 2012 European Academy of Dermatology and Venereology.

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial.

PubMed

Borius, Pierre-Yves; Garnier, Stéphanie Ranque; Baumstarck, Karine; Castinetti, Frédéric; Donnet, Anne; Guedj, Eric; Cornu, Philippe; Blond, Serge; Salas, Sébastien; Régis, Jean

2017-08-02

Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life. Copyright © 2017 by the Congress of Neurological Surgeons

A study of donepezil in female breast cancer survivors with self-reported cognitive dysfunction 1 to 5 years following adjuvant chemotherapy.

PubMed

Lawrence, J A; Griffin, L; Balcueva, E P; Groteluschen, D L; Samuel, T A; Lesser, G J; Naughton, M J; Case, L D; Shaw, E G; Rapp, S R

2016-02-01

Some breast cancer survivors report cognitive difficulties greater than 1 year after chemotherapy. Acetylcholinesterase inhibitors (AChEI) may improve cognitive impairment. We conducted a randomized, placebo-controlled, pilot study to assess the feasibility of using the AChEI, donepezil, to improve subjective and objective measures of cognitive function in breast cancer survivors. Women who received adjuvant chemotherapy 1-5 years prior with current cognitive dysfunction symptoms were randomized to 5 mg of donepezil/day vs placebo for 6 weeks and if tolerated 10 mg/day for 18 weeks for a total of 24 weeks. A battery of validated measures of attention, memory, language, visuomotor skills, processing speed, executive function, and motor dexterity and speed was administered at baseline and at 24 and 36 weeks. Subjective cognitive function, fatigue, sleep, mood, and health-related quality of life were evaluated at baseline and at 12, 24, and 36 weeks. Sixty-two patients were enrolled, 76 % completed the study, self-reported compliance was 98 %, and toxicities were minimal. At the end of treatment, the donepezil group performed significantly better than the control group on two parameters of memory-the Hopkins Verbal Learning Test -Revised (HVLT-R) Total Recall (p = 0.033) and HVLT-R Discrimination (p = 0.036). There were no significant differences on other cognitive variables or in subjective cognitive function or quality of life. Accrual to this feasibility trial was robust, retention was good, compliance was excellent, and toxicities were minimal. Randomized clinical trials in breast cancer survivors to improve cognitive dysfunction are feasible. A phase III trial testing the efficacy of donepezil is warranted given these pilot results.

Surgical Mask to Prevent Influenza Transmission in Households: A Cluster Randomized Trial

PubMed Central

Canini, Laetitia; Andréoletti, Laurent; Ferrari, Pascal; D'Angelo, Romina; Blanchon, Thierry; Lemaitre, Magali; Filleul, Laurent; Ferry, Jean-Pierre; Desmaizieres, Michel; Smadja, Serge; Valleron, Alain-Jacques; Carrat, Fabrice

2010-01-01

Background Facemasks and respirators have been stockpiled during pandemic preparedness. However, data on their effectiveness for limiting transmission are scarce. We evaluated the effectiveness of facemask use by index cases for limiting influenza transmission by large droplets produced during coughing in households. Methodology and Principal Findings A cluster randomized intervention trial was conducted in France during the 2008–2009 influenza season. Households were recruited during a medical visit of a household member with a positive rapid influenza A test and symptoms lasting less than 48 hours. Households were randomized either to the mask or control group for 7 days. In the intervention arm, the index case had to wear a surgical mask from the medical visit and for a period of 5 days. The trial was initially intended to include 372 households but was prematurely interrupted after the inclusion of 105 households (306 contacts) following the advice of an independent steering committee. We used generalized estimating equations to test the association between the intervention and the proportion of household contacts who developed an influenza-like illness during the 7 days following the inclusion. Influenza-like illness was reported in 24/148 (16.2%) of the contacts in the intervention arm and in 25/158 (15.8%) of the contacts in the control arm and the difference between arms was 0.40% (95%CI: −10% to 11%, P = 1.00). We observed a good adherence to the intervention. In various sensitivity analyses, we did not identify any trend in the results suggesting effectiveness of facemasks. Conclusion This study should be interpreted with caution since the lack of statistical power prevents us to draw formal conclusion regarding effectiveness of facemasks in the context of a seasonal epidemic. Trial Registration clinicaltrials.gov NCT00774774 PMID:21103330

[Effect of Xinling Wan in treatment of stable angina pectoris: a randomized, double-blinded, placebo parallel-controlled, multicenter trial].

PubMed

Gao, Jian-Wei; Gao, Xue-Min; Zou, Ting; Zhao, Tian-Meng; Wang, Dong-Hua; Wu, Zong-Gui; Ren, Chang-Jie; Wang, Xing; Geng, Nai-Zhi; Zhao, Ming-Jun; Liang, Qiu-Ming; Feng, Xing; Yang, Bai-Song; Shi, Jun-Ling; Hua, Qi

2018-03-01

To evaluate the effectiveness and safety of Xinling Wan on patients with stable angina pectoris, a randomized, double-blinded, placebo parallel-controlled, multicenter clinical trial was conducted. A total of 232 subjects were enrolled and randomly divided into experiment group and placebo group. The experiment group was treated with Xinling Wan (two pills each time, three times daily) for 4 weeks, and the placebo group was treated with placebo. The effectiveness evaluation showed that Xinling Wan could significantly increase the total duration of treadmill exercise among patients with stable angina pectoris. FAS analysis showed that the difference value of the total exercise duration was between experiment group (72.11±139.32) s and placebo group (31.25±108.32) s. Xinling Wan could remarkably increase the total effective rate of angina pectoris symptom score, and the analysis showed that the total effective rate was 78.95% in experiment group and 42.61% in placebo group. The reduction of nitroglycerin dose was (2.45±2.41) tablets in experiment group and (0.50±2.24) tablets in placebo group on the basis of FAS analysis. The decrease of symptom integral was (4.68±3.49) in experiment group and (3.19±3.31) in placebo group based on FAS analysis. Besides, Xinling Wan could decrease the weekly attack time and the duration of angina pectoris. PPS analysis results were similar to those of FAS analysis. In conclusion, Xinling Wan has an obvious therapeutic effect in treating stable angina pectoris, with a good safety and a low incidence of adverse event and adverse reaction in experiment group. Copyright© by the Chinese Pharmaceutical Association.

Phase II double-blind placebo-controlled randomized study of armodafinil for brain radiation-induced fatigue

PubMed Central

Page, Brandi R.; Shaw, Edward G.; Lu, Lingyi; Bryant, David; Grisell, David; Lesser, Glenn J.; Monitto, Drew C.; Naughton, Michelle J.; Rapp, Stephen R.; Savona, Steven R.; Shah, Sunjay; Case, Doug; Chan, Michael D.

2015-01-01

Background Common acute-term side effects of brain radiotherapy (RT) include fatigue, drowsiness, decreased physical functioning, and decreased quality of life (QOL). We hypothesized that armodafinil (a wakefulness-promoting drug known to reduce fatigue and increase cognitive function in breast cancer patients receiving chemotherapy) would result in reduced fatigue and sleepiness for patients receiving brain RT. Methods A phase II, multi-institutional, placebo-controlled randomized trial assessed feasibility of armodafinil 150 mg/day in participants receiving brain RT, from whom we obtained estimates of variability for fatigue, sleepiness, QOL, cognitive function, and treatment effect. Results From September 20, 2010, to October 20, 2012, 54 participants enrolled with 80% retention and 94% self-reported compliance. There were no grade 4–5 toxicities, and the incidence of grade 2–3 toxicities was similar between treatment arms, the most common of which were anxiety and nausea (15%), headaches (19%), and insomnia (20%). There were no statistically significant differences in end-RT or 4 week post-RT outcomes between armodafinil and placebo in any outcomes (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue, Brief Fatigue Inventory, Epworth Sleepiness Scale, FACT-Brain, and FACIT-cognitive function). However, in participants with more baseline fatigue, those treated with armodafinil did better than those who received the placebo on the end-RT assessments for several outcomes. Conclusion Armodafinil 150 mg/day was well tolerated in primary brain tumor patients undergoing RT with good compliance. While there was no overall significant effect on fatigue, those with greater baseline fatigue experienced improved QOL and reduced fatigue when using armodafinil. These data suggest that a prospective, phase III randomized trial is warranted for patients with greater baseline fatigue. PMID:25972454

A double-blind randomized placebo-controlled trial with short-term beta-glucuronidase therapy in children with chronic rhinoconjunctivitis and/or asthma due to dust mite allergy.

PubMed

Galli, E; Bassi, M S; Mora, E; Martelli, M; Gianni, S; Auricchio, G; Arabito, E; Rossi, P

2006-01-01

Enzyme potentiated desensitization, in which beta-glucuronidase (BG) is administered with low doses of mixed allergens, was proposed in the 1970s for specific immunotherapy. The BG currently commercially available in a purified and standardized preparation devoid of any allergen has been suggested as a regulator in the allergic immune response, acting on the cytokine-network of type 2 helper T cells. A double-blind trial with a single-dose of BG proved effective in preventing symptoms in adult patients with rhinoconjunctivitis due to grass pollens. The aim of this randomized double-blind placebo-controlled trial was to confirm the safety and effectiveness of double-dose intradermal BG immunotherapy in preventing symptoms in children suffering from chronic rhinoconjunctivitis and/or asthma due to dust mite. We randomized 125 children with dust-mite related chronic rhinoconjunctivitis and/or asthma to the BG treated group (67) or the placebo group (58). All patients were screened before treatment (TO), at BG or placebo administration (T1 and T3), and at 3 and 9 months after T1 (T2 and T4). Drug intake and bronchial, nasal and ocular symptoms were recorded in a diary. Patients in both groups completed the study and BG treatment was well tolerated without side effects. Significant differences in symptoms were observed, in particular for conjunctivitis (P= .008). The total drug intake for allergic symptoms was significantly lower in the treated group than in the placebo group (P<. 01). BG immunotherapy is efficacious, safe, and well tolerated in allergic children. Moreover, good compliance with the administration of 2 doses per year and the lack of significant side effects makes the benefit/risk ratio of this treatment particularly favorable.

Bisphosphonates for treatment of Complex Regional Pain Syndrome type 1: A systematic literature review and meta-analysis of randomized controlled trials versus placebo.

PubMed

Chevreau, Maxime; Romand, Xavier; Gaudin, Philippe; Juvin, Robert; Baillet, Athan

2017-07-01

Complex Regional Pain Syndrome Type 1 is a severely disabling pain syndrome with no definite established treatment. We have performed a systematic literature review and meta-analysis of all randomized controlled trials to assess the benefit of bisphosphonates on pain and function in patients with Complex Regional Pain Syndrome Type 1. A systematic literature search was performed in the Medline, Embase and Cochrane databases. Two authors selected independently blinded randomized trials comparing bisphosphonates to placebo on short-term (J30 to J40) and medium term pain (M2-M3), safety and function in patients with CRPS 1. The methodological quality of the studies was analyzed. Data were aggregated using the method of the inverse of the variance. 258 articles were identified. Four trials of moderate to good quality comprising 181 patients (90 in the bisphosphonate group and 91 in the placebo group) were included in this meta-analysis. Short-term pain Visual Analog Scale was significantly lower in the bisphosphonate group versus the placebo group (SMD=-2.6, 95%CI [-1.8, -3.4], P<0.001), as well as the medium term Visual Analog Scale pain (SMD=-2.5, 95%CI [-1.4, -3.6], P<0.001). There were more adverse events in the bisphosphonate group (35.5%) than in the placebo group (16.4%) with a relative risk of 2.1 (95%CI [1.3, 3.5], P=0.004) and a number needed to harm of 4.6, (95%CI [2.4, 168.0]) but no serious side effects. Our results suggest that bisphosphonates reduce pain in patients with Complex Regional Pain Syndrome type 1. Other studies are needed to determine their effectiveness. Copyright © 2017. Published by Elsevier SAS.

Choice architecture to promote fruit and vegetable purchases by families participating in the Special Supplemental Program for Women, Infants, and Children (WIC): randomized corner store pilot study.

PubMed

Thorndike, Anne N; Bright, Oliver-John M; Dimond, Melissa A; Fishman, Ronald; Levy, Douglas E

2017-05-01

To conduct a pilot study to determine if improving the visibility and quality of fresh produce (choice architecture) in corner stores would increase fruit/vegetable purchases by families participating in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Six stores were randomly assigned to choice architecture intervention or control. Store-level WIC sales data were provided by the state. Primary outcomes were WIC fruit/vegetable voucher and non-fruit/vegetable voucher sales, comparing trends from baseline (December 2012-October 2013) with the five-month intervention period (December 2013-April 2014). Secondary outcomes were differences in customer self-reported fruit/vegetable purchases between baseline and end of the intervention. Chelsea, MA, USA, a low-income urban community. Adult customers (n 575) completing store exit interviews. During baseline, WIC fruit/vegetable and non-fruit/vegetable sales decreased in both intervention and control stores by $US 16/month. During the intervention period, WIC fruit/vegetable sales increased in intervention stores by $US 40/month but decreased in control stores by $US 23/month (difference in trends: $US 63/month; 95 % CI 4, 121 $US/month; P=0·036); WIC non-fruit/vegetable sales were not different (P=0·45). Comparing baseline and intervention-period exit interview responses by customers participating in WIC (n 134), intervention store customers reported increased fruit/vegetable purchases compared with control store customers (18 v. -2 %), but this did not achieve statistical significance (P=0·11). Placement of fruits/vegetables near the front of corner stores increased purchase of produce by customers using WIC. New policies that incentivize stores to stock and prominently display good-quality produce could promote healthier food choices of low-income families.

Challenges in randomized controlled trials and emerging multiple sclerosis therapeutics.

PubMed

Huang, DeRen

2015-12-01

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

Cost-Effectiveness of Wisconsin TEAM Model for Improving Adherence and Hypertension Control in Black Patients

PubMed Central

Shireman, Theresa I.; Svarstad, Bonnie L.

2016-01-01

Objective To assess the cost-effectiveness of the 6-month Team Education and Adherence Monitoring (TEAM) intervention for black patients with hypertension in community pharmacies using prospectively collected cost data. Design Cost-effectiveness analysis of a cluster-randomized trial. Setting 28 chain pharmacies in five Wisconsin cities from December 2006 to February 2009. Participants 576 black patients with uncontrolled hypertension Intervention Pharmacists and pharmacy technicians using novel tools for improving adherence and feedback to patients and physicians as compared to information only control group. Main outcome measure(s) Incremental cost analysis of variable costs from the pharmacy perspective captured prospectively at the participant level. Outcomes (effect measures) were 6-month refill adherence, changes in SBP and DBP, and proportion of patients achieving BP control. Results Mean cost of intervention personnel time and tools was $104.8± 45.2. Incremental variable costs per mmHg decrease in SBP and DBP were $22.2 ± 16.3 and $66.0 ± 228.4, respectively. The cost of helping one more person achieve the BP goal (< 140/90) was $665.2 ± 265.2; the cost of helping one more person achieve good refill adherence was $463.3 ± 110.7. Prescription drug costs were higher for the TEAM group ($392.8, SD = 396.3 versus $307.0, SD = 295.2, p = 0.02). The start-up cost for pharmacy furniture, equipment, and privacy screen was $168 per pharmacy. Conclusions Our randomized, practice based intervention demonstrated that community pharmacists can implement a cost-effective intervention to improve hypertension control in blacks. This approach imposes a nominal expense at the pharmacy level, can be integrated into the ongoing pharmacist-patient relationship, and can enhance clinical and behavioral outcomes. PMID:27184784

Enhanced cognitive behavioral therapy for eating disorders adapted for a group setting.

PubMed

Wade, Stephanie; Byrne, Sue; Allen, Karina

2017-08-01

This randomized control trial is an evaluation of the effectiveness of enhanced cognitive behavioral treatment (CBT-E) for eating disorders adapted for a group setting. The study aimed to examine the effects of group CBT-E on eating disorder psychopathology and additional maintaining pathology. A transdiagnostic sample of individuals with eating disorders with a BMI ≥ 18 kg/m 2 (N = 40) were randomized to an immediate-start or delayed-start condition so as to compare therapeutic effects of group CBT-E with a waitlist control. Global Eating Disorder Examination Questionnaire (EDE-Q) scores, BMI, and measures of Clinical Perfectionism, Self-Esteem, Interpersonal Difficulties, and Mood Intolerance were measured across the 8-week control period, throughout the group treatment and at 3-months post-treatment. Over 70% of those who entered the trial completed treatment. The first eight weeks of group CBT-E were more effective at reducing Global EDE-Q scores than no treatment (waitlist control). By post-treatment, good outcome (a Global EDE-Q within 1 SD of Australian community norms plus BMI ≥ 18.5) was achieved by 67.9% of treatment completers and 66.7% of the total sample. Symptom abstinence within the previous month was reported by 14.3% of treatment completers and 10.3% of the total sample. Significant reductions in Clinical Perfectionism, Self-Esteem, Interpersonal Difficulties, and Mood Intolerance were also observed. This study demonstrated that a group version of CBT-E can be effective at reducing eating disorder psychopathology in a transdiagnostic sample of individuals with eating disorders. Group CBT-E could provide a means of increasing availability of evidence-based treatment for eating disorders. © 2017 Wiley Periodicals, Inc.

Systematic review of interventions for children with Fetal Alcohol Spectrum Disorders

PubMed Central

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

2009-01-01

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

Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study.

PubMed

Cho, Yoon Soo; Joo, So Young; Cui, Huisong; Cho, Sung-Rae; Yim, Haejun; Seo, Cheong Hoon

2016-08-01

Extracorporeal shock wave therapy (ESWT) has been used to reduce pain in patients with various musculoskeletal diseases and wounds. We investigated the effect of ESWT on scar pain after complete wound epithelialization in burn patients. A prospective, single-blind, placebo-controlled study was conducted from February 2014 to 2015. Forty patients with burn scar pain despite standard therapy (medication, physical therapy, and burn rehabilitation massage therapy) were randomized into ESWT or control (sham ESWT) groups. ESWT was administered at 100 impulses/cm (0.05-0.15 mJ/mm) once per week for 3 weeks. The treatment effects were assessed using the numerical rating scale (NRS), pain threshold, Nirschl pain phase system, and Roles and Maudsley scores. The characteristics of patients between the 2 study groups were balanced (P >0.05) for age, sex, and total burn surface area (%). In both groups, the NRS, pain threshold (Ib/cm), and Nirschl pain phase system values significantly improved (P <0.05) after 3 sessions of ESWT or sham therapy, and there were significant differences between the 2 groups in terms of these 3 variables (P <0.001, P <0.001, P = 0.013, respectively). The Roles and Maudsley scores significantly improved; among 20 patients, 17 reported a score of poor (85%) and 3 reported fair (15%) before ESWT, whereas 3 reported poor (15%), 8 reported fair (40%), 5 reported good (25%), and 4 reported excellent (20%) after ESWT (P = 0.004). The scores did not improve in the control group (P = 0.128). ESWT significantly reduced scar pain in burn patients after wound recovery.

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus.

PubMed

Goday, A; Bellido, D; Sajoux, I; Crujeiras, A B; Burguera, B; García-Luna, P P; Oleaga, A; Moreno, B; Casanueva, F F

2016-09-19

Brackground:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients. Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional weight loss program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM. Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m(-)(2) participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional weight loss (VLCK diet), and 44 to the standard low-calorie diet. No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up. The interventional weight loss program based on a VLCK diet is most effective in reducing body weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.

Promoting Physical Activity in Middle School Girls: Trial of Activity for Adolescent Girls

PubMed Central

Webber, Larry S.; Catellier, Diane J.; Lytle, Leslie A.; Murray, David M.; Pratt, Charlotte A.; Young, Deborah R.; Elder, John P.; Lohman, Timothy G.; Stevens, June; Jobe, Jared B.; Pate, Russell R.

2008-01-01

Background Physical activity is important for weight control and good health; however, activity levels decline in the adolescent years, particularly in girls. Design Group randomized controlled trial Setting/participants Middle school girls with English-speaking skills and no conditions to prevent participation in physical activity in 36 schools in six geographically diverse areas of the United States. Random, cross-sectional samples were drawn within schools: 6th graders in 2003 (n=1721) and 8th graders in 2005 (n=3504) and 2006 (n=3502). Intervention A 2-year study-directed intervention (fall 2003 to spring 2005) targeted schools, community agencies, and girls to increase opportunities, support, and incentives for increased physical activity. Components included programs linking schools and community agencies, physical education, health education, and social marketing. A third-year intervention used school and community personnel to direct intervention activities. Main outcome measures The primary outcome, daily MET-weighted minutes of moderate-to-vigorous physical activity (MET-weighted MVPA), was assessed using accelerometry. Percent body fat was assessed using anthropometry. Results After the staff-directed intervention (pre-stated primary outcome), there were no differences (mean= −0.4, 95% CI= CI= −8.2 to 7.4) in adjusted MET-weighted MVPA between 8th-grade girls in schools assigned to intervention or control. Following the Program Champion–directed intervention, girls in intervention schools were more physically active than girls in control schools (mean difference 10.9 MET-weighted minutes of MVPA, 95% CI=0.52–21.2). This difference is about 1.6 minutes of daily MVPA or 80 kcal per week. There were no differences in fitness or percent body fat at either 8th-grade timepoint. Conclusion A school-based, community-linked intervention modestly improved physical activity in girls. PMID:18312804

Effects of intentionally enhanced chocolate on mood.

PubMed

Radin, Dean; Hayssen, Gail; Walsh, James

2007-01-01

A double-blind, randomized, placebo-controlled experiment investigated whether chocolate exposed to "good intentions" would enhance mood more than unexposed chocolate. Individuals were assigned to one of four groups and asked to record their mood each day for a week by using the Profile of Mood States. For days three, four and five, each person consumed a half ounce of dark chocolate twice a day at prescribed times. Three groups blindly received chocolate that had been intentionally treated by three different techniques. The intention in each case was that people who ate the chocolate would experience an enhanced sense of energy, vigor, and well-being. The fourth group blindly received untreated chocolate as a placebo control. The hypothesis was that mood reported during the three days of eating chocolate would improve more in the intentional groups than in the control group. Stratified random sampling was used to distribute 62 participants among the four groups, matched for age, gender, and amount of chocolate consumed on average per week. Most participants lived in the same geographic region to reduce mood variations due to changes in weather, and the experiment was conducted during one week to reduce effects of current events on mood fluctuations. On the third day of eating chocolate, mood had improved significantly more in the intention conditions than in the control condition (P = .04). Analysis of a planned subset of individuals who habitually consumed less than the grand mean of 3.2 ounces of chocolate per week showed a stronger improvement in mood (P = .0001). Primary contributors to the mood changes were the factors of declining fatigue (P = .01) and increasing vigor (P = .002). All three intentional techniques contributed to the observed results. The mood-elevating properties of chocolate can be enhanced with intention.

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.

A randomized controlled trial of internet-based therapy in depression.

PubMed

Moritz, Steffen; Schilling, Lisa; Hauschildt, Marit; Schröder, Johanna; Treszl, András

2012-08-01

Depression is among the most prevalent disorders worldwide. In view of numerous treatment barriers, internet-based interventions are increasingly adopted to "treat the untreated". The present trial (registered as NCT01401296) was conducted over the internet and aimed to assess the efficacy of an online self-help program for depression (Deprexis). In random order, participants with elevated depression symptoms received program access or were allocated to a wait-list control condition. After eight weeks, participants were invited to take part in an online re-assessment. To compensate for common problems of online studies, such as low completion rates and unclear diagnostic status, reminders and incentives were used, and clinical diagnoses were externally confirmed in a subgroup of 29% of participants. Relative to the wait-list group, program users experienced significant symptom decline on the Beck Depression Inventory (BDI; primary outcome), the Dysfunctional Attitudes Scale (DAS), the Quality of Life scale (WHOQOL-BREF) and the Rosenberg Self-Esteem Scale (RSE). Compared to wait-list participants, symptom decline was especially pronounced among those with moderate symptoms at baseline as well as those not currently consulting a therapist. Completion (82%) and re-test reliability of the instruments (r = .72-.87) were good. The results of this trial suggest that online treatment can be beneficial for people with depression, particularly for those with moderate symptoms. Copyright © 2012 Elsevier Ltd. All rights reserved.

A systematic review of evidence for the effectiveness of practitioner-based complementary and alternative therapies in the management of rheumatic diseases: osteoarthritis.

PubMed

Macfarlane, Gary J; Paudyal, Priya; Doherty, Michael; Ernst, Edzard; Lewith, George; MacPherson, Hugh; Sim, Julius; Jones, Gareth T

2012-12-01

To critically review the evidence on the efficacy and effectiveness of practitioner-based complementary therapies for patients with osteoarthritis. We excluded t'ai chi and acupuncture, which have been the subject of recent reviews. Randomized controlled trials, published in English up to May 2011, were identified using systematic searches of bibliographic databases and searching of reference lists. Information was extracted on outcomes, statistical significance in comparison with alternative treatments and reported side effects. The methodological quality of the identified studies was determined using the Jadad scoring system. Outcomes considered were pain and patient global assessment. In all, 16 eligible trials were identified covering 12 therapies. Overall, there was no good evidence of the effectiveness of any of the therapies in relation to pain or global health improvement/quality of life because most therapies only had a single randomized controlled trial. Where positive results were reported, they were often comparing an active intervention with no intervention. Therapies with multiple trials either provided null (biofeedback) or inconsistent results (magnet therapy), or the trials available scored poorly for quality (chiropractic). There were few adverse events reported in the trials. There is not sufficient evidence to recommend any of the practitioner-based complementary therapies considered here for the management of OA, but neither is there sufficient evidence to conclude that they are not effective or efficacious.

Randomized controlled trials and meta-analysis in medical education: what role do they play?

PubMed

Cook, David A

2012-01-01

Education researchers seek to understand what works, for whom, in what circumstances. Unfortunately, educational environments are complex and research itself is highly context dependent. Faced with these challenges, some have argued that qualitative methods should supplant quantitative methods such as randomized controlled trials (RCTs) and meta-analysis. I disagree. Good qualitative and mixed-methods research are complementary to, rather than exclusive of, quantitative methods. The complexity and challenges we face should not beguile us into ignoring methods that provide strong evidence. What, then, is the proper role for RCTs and meta-analysis in medical education? First, the choice of study design depends on the research question. RCTs and meta-analysis are appropriate for many, but not all, study goals. They have compelling strengths but also numerous limitations. Second, strong methods will not compensate for a pointless question. RCTs do not advance the science when they make confounded comparisons, or make comparison with no intervention. Third, clinical medicine now faces many of the same challenges we encounter in education. We can learn much from other fields about how to handle complexity in RCTs. Finally, no single study will definitively answer any research question. We need carefully planned, theory-building, programmatic research, reflecting a variety of paradigms and approaches, as we accumulate evidence to change the art and science of education.

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

PubMed

Weaver, Christopher S; Terrell, Kevin M

2003-01-01

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

A randomized controlled trial of aromatherapy massage in a hospice setting.

PubMed

Soden, Katie; Vincent, Karen; Craske, Stephen; Lucas, Caroline; Ashley, Sue

2004-03-01

Research suggests that patients with cancer, particularly in the palliative care setting, are increasingly using aromatherapy and massage. There is good evidence that these therapies may be helpful for anxiety reduction for short periods, but few studies have looked at the longer term effects. This study was designed to compare the effects of four-week courses of aromatherapy massage and massage alone on physical and psychological symptoms in patients with advanced cancer. Forty-two patients were randomly allocated to receive weekly massages with lavender essential oil and an inert carrier oil (aromatherapy group), an inert carrier oil only (massage group) or no intervention. Outcome measures included a Visual Analogue Scale (VAS) of pain intensity, the Verran and Snyder-Halpern (VSH) sleep scale, the Hospital Anxiety and Depression (HAD) scale and the Rotterdam Symptom Checklist (RSCL). We were unable to demonstrate any significant long-term benefits of aromatherapy or massage in terms of improving pain control, anxiety or quality of life. However, sleep scores improved significantly in both the massage and the combined massage (aromatherapy and massage) groups. There were also statistically significant reductions in depression scores in the massage group. In this study of patients with advanced cancer, the addition of lavender essential oil did not appear to increase the beneficial effects of massage. Our results do suggest, however, that patients with high levels of psychological distress respond best to these therapies.

Diode laser surgery versus scalpel surgery in the treatment of fibrous hyperplasia: a randomized clinical trial.

PubMed

Amaral, M B F; de Ávila, J M S; Abreu, M H G; Mesquita, R A

2015-11-01

Fibrous hyperplasia is treated by surgical incision using a scalpel, together with removal of the source of chronic trauma. However, scalpel techniques do not provide the haemostasis that is necessary when dealing with highly vascular tissues. Diode laser surgery can be used in the management of oral tissues due to its high absorption by water and haemoglobin, and has provided good results in both periodontal surgery and oral lesions. The aim of the present study was to compare the effects of diode laser surgery to those of the conventional technique in patients with fibrous hyperplasia. A randomized clinical trial was performed in which surgical and postoperative evaluations were analyzed. On comparison of the laser-treated (study group) patients to those treated with a scalpel (control group), significant differences were observed in the duration of surgery and the use of analgesic medications. Over a 3-week period, clinical healing of the postoperative wound was significantly faster in the control group as compared to the study group. In conclusion, diode laser surgery proved to be more effective and less invasive when compared to scalpel surgery in the management of fibrous hyperplasia. However, wound healing proved to be faster when using scalpel surgery. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

[Compliancy of pre-exposure prophylaxis for HIV infection in men who have sex with men in Chengdu].

PubMed

Xu, J Y; Mou, Y C; Ma, Y L; Zhang, J Y

2017-05-10

Objective: To evaluate the compliancy of HIV pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM) in Chengdu, Sichuan province, and explore the influencing factors. Methods: From 1 July 2013 to 30 September 2015, a random, open, multi-center and parallel control intervention study was conducted in 328 MSM enrolled by non-probability sampling in Chengdu. The MSM were divided into 3 groups randomly, i.e. daily group, intermittent group (before and after exposure) and control group. Clinical follow-up and questionnaire survey were carried out every 3 months. Their PrEP compliances were evaluated respectively and multivariate logistic regression analysis was conducted to identify the related factors. Results: A total of 141 MSM were surveyed, in whom 59(41.8 % ) had good PrEP compliancy. The PrEP compliancy rate was 69.0 % in daily group, higher than that in intermittent group (14.3 % ), the difference had significance ( χ (2)=45.29, P <0.001). Multivariate logistic analysis indicated that type of PrEP was the influencing factors of PrEP compliancy. Compared with daily group, the intermittent group had worse PrEP compliancy ( OR =0.07, 95 %CI : 0.03-0.16). Conclusion: The PrEP compliance of the MSM in this study was poor, the compliancy would be influenced by the type of PrEP.

A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia.

PubMed

Holtmann, G; Gschossmann, J; Mayr, P; Talley, N J

2002-09-01

To compare the efficacy of simethicone with placebo and the prokinetic cisapride in patients with functional dyspepsia. One hundred and eighty-five patients with functional dyspepsia were randomized and treated in a double-dummy technique with simethicone (105 mg t.d.s.), cisapride (10 mg t.d.s.) or placebo (t.d.s.). The primary outcome measure was the O'Brien global measure of the patients' rating of 10 upper gastrointestinal symptoms (graded as absent = 0, moderate = 1, severe = 2 or very severe = 3). Outcome measures were assessed at baseline and after 2, 4 and 8 weeks of treatment (intention-to-treat). At 2, 4 and 8 weeks, treatment with simethicone and cisapride yielded significantly (all P values < 0.0001) better improvement of symptoms compared to placebo. Simethicone was significantly better than cisapride after 2 weeks (P = 0.0007), but the differences were not statistically significant after 4 and 8 weeks. Patients treated with simethicone judged the efficacy of their treatment as very good in 46% of cases, compared to 15% and 16% receiving cisapride and placebo, respectively. Simethicone and cisapride were significantly better than placebo for symptom control in patients with functional dyspepsia after 2, 4 and 8 weeks of treatment. Simethicone was also superior to the prokinetic cisapride in the first 2 weeks of treatment.

Meta-analysis of food safety training on hand hygiene knowledge and attitudes among food handlers.

PubMed

Soon, Jan Mei; Baines, Richard; Seaman, Phillip

2012-04-01

Research has shown that traditional food safety training programs and strategies to promote hand hygiene increases knowledge of the subject. However, very few studies have been conducted to evaluate the impact of food safety training on food handlers' attitudes about good hand hygiene practices. The objective of this meta-analytical study was to assess the extent to which food safety training or intervention strategies increased knowledge of and attitudes about hand hygiene. A systematic review of food safety training articles was conducted. Additional studies were identified from abstracts from food safety conferences and food science education conferences. Search terms included combinations of "food safety," "food hygiene," "training," "education," "hand washing," "hand hygiene," "knowledge," "attitudes," "practices," "behavior," and "food handlers." Only before- and after-training approaches and cohort studies with training (intervention group) and without training (control group) in hand hygiene knowledge and including attitudes in food handlers were evaluated. All pooled analyses were based on a random effects model. Meta-analysis values for nine food safety training and intervention studies on hand hygiene knowledge among food handlers were significantly higher than those of the control (without training), with an effect size (Hedges' g) of 1.284 (95% confidence interval [CI] ∼ 0.830 to 1.738). Meta-analysis of five food safety training and intervention studies in which hand hygiene attitudes and self-reported practices were monitored produced a summary effect size of 0.683 (95% CI ∼ 0.523 to 0.843). Food safety training increased knowledge and improved attitudes about hand hygiene practices. Refresher training and long-term reinforcement of good food handling behaviors may also be beneficial for sustaining good hand washing practices.

A 2011 Updated Systematic Review and Clinical Practice Guideline for the Management of Malignant Extradural Spinal Cord Compression

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

Loblaw, D. Andrew, E-mail: andrew.loblaw@sunnybrook.ca; Mitera, Gunita; Ford, Michael

2012-10-01

Purpose: To update the 2005 Cancer Care Ontario practice guidelines for the diagnosis and treatment of adult patients with a suspected or confirmed diagnosis of extradural malignant spinal cord compression (MESCC). Methods: A review and analysis of data published from January 2004 to May 2011. The systematic literature review included published randomized control trials (RCTs), systematic reviews, meta-analyses, and prospective/retrospective studies. Results: An RCT of radiation therapy (RT) with or without decompressive surgery showed improvements in pain, ambulatory ability, urinary continence, duration of continence, functional status, and overall survival. Two RCTs of RT (30 Gy in eight fractions vs. 16more » Gy in two fractions; 16 Gy in two fractions vs. 8 Gy in one fraction) in patients with a poor prognosis showed no difference in ambulation, duration of ambulation, bladder function, pain response, in-field failure, and overall survival. Retrospective multicenter studies reported that protracted RT schedules in nonsurgical patients with a good prognosis improved local control but had no effect on functional or survival outcomes. Conclusions: If not medically contraindicated, steroids are recommended for any patient with neurologic deficits suspected or confirmed to have MESCC. Surgery should be considered for patients with a good prognosis who are medically and surgically operable. RT should be given to nonsurgical patients. For those with a poor prognosis, a single fraction of 8 Gy should be given; for those with a good prognosis, 30 Gy in 10 fractions could be considered. Patients should be followed up clinically and/or radiographically to determine whether a local relapse develops. Salvage therapies should be introduced before significant neurologic deficits occur.« less

Metasurfaced Reverberation Chamber.

PubMed

Sun, Hengyi; Li, Zhuo; Gu, Changqing; Xu, Qian; Chen, Xinlei; Sun, Yunhe; Lu, Shengchen; Martin, Ferran

2018-01-25

The concept of metasurfaced reverberation chamber (RC) is introduced in this paper. It is shown that by coating the chamber wall with a rotating 1-bit random coding metasurface, it is possible to enlarge the test zone of the RC while maintaining the field uniformity as good as that in a traditional RC with mechanical stirrers. A 1-bit random coding diffusion metasurface is designed to obtain all-direction backscattering under normal incidence. Three specific cases are studied for comparisons, including a (traditional) mechanical stirrer RC, a mechanical stirrer RC with a fixed diffusion metasurface, and a RC with a rotating diffusion metasurface. Simulation results show that the compact rotating diffusion metasurface can act as a stirrer with good stirring efficiency. By using such rotating diffusion metasurface, the test region of the RC can be greatly extended.

Low-Budget Instrumentation of a Conventional Leg Press to Measure Reliable Isometric-Strength Capacity.

PubMed

Baur, Heiner; Groppa, Alessia Severina; Limacher, Regula; Radlinger, Lorenz

2016-02-02

Maximum strength and rate of force development (RFD) are 2 important strength characteristics for everyday tasks and athletic performance. Measurements of both parameters must be reliable. Expensive isokinetic devices with isometric modes are often used. The possibility of cost-effective measurements in a practical setting would facilitate quality control. The purpose of this study was to assess the reliability of measurements of maximum isometric strength (Fmax) and RFD on a conventional leg press. Sixteen subjects (23 ± 2 y, 1.68 ± 0.05 m, 59 ± 5 kg) were tested twice within 1 session. After warm-up, subjects performed 2 times 5 trials eliciting maximum voluntary isometric contractions on an instrumented leg press (1- and 2-legged randomized). Fmax (N) and RFD (N/s) were extracted from force-time curves. Reliability was determined for Fmax and RFD by calculating the intraclass correlation coefficient (ICC), the test-retest variability (TRV), and the bias and limits of agreement. Reliability measures revealed good to excellent ICCs of .80-.93. TRV showed mean differences between measurement sessions of 0.4-6.9%. The systematic error was low compared with the absolute mean values (Fmax 5-6%, RFD 1-4%). The implementation of a force transducer into a conventional leg press provides a viable procedure to assess Fmax and RFD. Both performance parameters can be assessed with good to excellent reliability allowing quality control of interventions.

All part of the job? The contribution of the psychosocial and physical work environment to health inequalities in Europe and the European health divide.

PubMed

Toch, Marlen; Bambra, Clare; Lunau, Thorsten; van der Wel, Kjetil A; Witvliet, Margot I; Dragano, Nico; Eikemo, Terje A

2014-01-01

This study is the first to examine the contribution of both psychosocial and physical risk factors to occupational inequalities in self-assessed health in Europe. Data from 27 countries were obtained from the 2010 European Working Conditions Survey for men and women aged 16 to 60 (n = 21,803). Multilevel logistic regression analyses (random intercept) were applied, estimating odds ratios of reporting less than good health. Analyses indicate that physical working conditions account for a substantial proportion of occupational inequalities in health in both Central/Eastern and Western Europe. Physical, rather than psychosocial, working conditions seem to have the largest effect on self-assessed health in manual classes. For example, controlling for physical working conditions reduced the inequalities in the prevalence of"less than good health" between the lowest (semi- and unskilled manual workers) and highest (higher controllers) occupational groups in Europe by almost 50 percent (Odds Ratio 1.87, 95% Confidence Interval 1.62-2.16 to 1.42, 1.23-1.65). Physical working conditions contribute substantially to health inequalities across "post-industrial" Europe, with women in manual occupations being particularly vulnerable, especially those living in Central/Eastern Europe. An increased political and academic focus on physical working conditions is needed to explain and potentially reduce occupational inequalities in health.

The effect of Iron Supplying on VO2 MAX and Haematology Parameter on Menstrual Woman

NASA Astrophysics Data System (ADS)

Nailuvar Sinaga, Rika; Sari Harahap, Novita; Mediyana Sari, Rima

2018-03-01

One of the supporting factors to have good aerobic endurance requires high VO2 max levels supported by good quality and quantity level of Haematology parameter especially such as erythrocytes, hematocrit and hemoglobin. One of the components in hemoglobin is iron which functions as theoxygen transport to parts of all body required in the process of metabolism. The objective of this research was to find out the difference between VO2 Max and Haematology parameter between iron supplying and no iron supplyingonmenstrual woman. The type of this research is quasi experimental research with non-randomized control group Pretest-Postest Design. The subjectsarethe studentsat faculty of Sports Sciences, Medan State University with the criteria of female gender, monthly regular menstrual cycle, having the level of health and the level of training, willing to be a sample by filling out informed consent. The total number of research subjectsis twenty students, divided into two groups namely the treatment group and the control group. The hematology parameter was measuredby Haemotology analyzer and VO2 Max was measured by multi-stage run. The result showed that there was a significant effect of iron supplyingon the increase of erythrocyte level on menstrual women, hemotocrit, haemoglobin and an increase in VO2 Max. Iron supplying on menstrual woman has the effect on the increase of erythrocyte, hematocrit, hemoglobin level and VO2 Max

Mentoring Interventions for Underrepresented Scholars in Biomedical and Behavioral Sciences: Effects on Quality of Mentoring Interactions and Discussions

PubMed Central

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

2017-01-01

Mentors rarely receive education about the unique needs of underrepresented scholars in the biomedical and behavioral sciences. We hypothesized that mentor-training and peer-mentoring interventions for these scholars would enrich the perceived quality and breadth of discussions between mentor–protégé dyads (i.e., mentor–protégé pairs). Our multicenter, randomized study of 150 underrepresented scholar–mentor dyads compared: 1) mentor training, 2) protégé peer mentoring, 3) combined mentor training and peer mentoring, and 4) a control condition (i.e., usual practice of mentoring). In this secondary analysis, the outcome variables were quality of dyad time and breadth of their discussions. Protégé participants were graduate students, fellows, and junior faculty in behavioral and biomedical research and healthcare. Dyads with mentor training were more likely than those without mentor training to have discussed teaching and work–life balance. Dyads with peer mentoring were more likely than those without peer mentoring to have discussed clinical care and career plans. The combined intervention dyads were more likely than controls to perceive that the quality of their time together was good/excellent. Our study supports the value of these mentoring interventions to enhance the breadth of dyad discussions and quality of time together, both important components of a good mentoring relationship. PMID:28747354

Factors associated with good TB infection control practices among primary healthcare workers in the Free State Province, South Africa.

PubMed

Engelbrecht, Michelle; Janse van Rensburg, André; Kigozi, Gladys; van Rensburg, Hcj Dingie

2016-11-04

Despite the availability of TB infection control guidelines, and good levels of healthcare worker knowledge about infection control, often these measures are not well implemented. This study sought to determine the factors associated with healthcare workers' good TB infection control practices in primary health care facilities in the Free State Province, South Africa. A cross-sectional self-administered survey among nurses (n = 202) and facility-based community healthcare workers (n = 34) as well as facility observations were undertaken at all 41 primary health care facilities in a selected district of the Free State Province. The majority of respondents were female (n = 200; 87.7 %) and the average age was 44.19 years (standard deviation ±10.82). Good levels of knowledge were recorded, with 42.8 % (n = 101) having an average score (i.e. 65-79 %) and 31.8 % (n = 75) a good score (i.e. ≥ 80 %). Most respondents (n = 189; 80.4 %) had positive attitudes towards TB infection control practices (i.e. ≥ 80 %). While good TB infection control practices were reported by 72.9 % (n = 161) of the respondents (i.e. ≥75 %), observations revealed this to not necessarily be the case. For every unit increase in attitudes, good practices increased 1.090 times (CI:1.016-1.169). Respondents with high levels of knowledge (≥80 %) were 4.029 (CI: 1.550-10.469) times more likely to have good practices when compared to respondents with poor levels of knowledge (<65 %). The study did not find TB/HIV-related training to be a predictor of good practices. Positive attitudes and good levels of knowledge regarding TB infection control were the main factors associated with good infection control practices. Although many respondents reported good infection control practices - which was somewhat countered by the observations - there are areas that require attention, particularly those related to administrative controls and the use of personal protective equipment.

A Randomized Controlled Trial of Intensive Sleep Retraining (ISR): A Brief Conditioning Treatment for Chronic Insomnia

PubMed Central

Harris, Jodie; Lack, Leon; Kemp, Kristyn; Wright, Helen; Bootzin, Richard

2012-01-01

Study Objective: To investigate the effectiveness of intensive sleep retraining in comparison and combination with traditional behavioral intervention for chronic primary insomnia. Participants: Seventy-nine volunteers with chronic sleep-onset insomnia (with or without sleep maintenance difficulties) were randomly assigned either to intensive sleep retraining (ISR), stimulus control therapy (SCT), ISR plus SCT, or the control (sleep hygiene) treatment condition. Intervention: ISR treatment consisted of 50 sleep onset trials over a 25-h sleep deprivation period. Measurements and Results: Treatment response was assessed with sleep diary, activity monitoring, and questionnaire measures. The active treatment groups (ISR, SCT, ISR+SCT) all resulted in significant improvements in sleep onset latency and sleep efficiency, with moderate to large effect sizes from pre- to post-treatment. Wake time after sleep onset decreased significantly in the SCT and ISR+SCT groups. Total sleep time increased significantly in the ISR and ISR+SCT treatment groups. Participants receiving ISR (ISR, ISR+SCT) experienced rapidly improved SOL and TST during treatment, suggesting an advantage of rapid improvements in sleep in response to ISR. Although there were few statistically significant differences between groups on individual variables, ISR+SCT resulted in consistently larger effect sizes of change than other treatments, including questionnaire measures of sleep quality, sleep self-efficacy, and daytime functioning. The combination treatment group (ISR+SCT) showed trends to outperform other active treatment groups with fewer treatment dropouts, and a greater proportion of treatment responders with 61% reaching “good sleeper” status. Treatment gains achieved at post-treatment in the active treatment groups were largely maintained throughout follow-up periods to 6 months. Conclusion: This 25-hour intensive conditioning treatment for chronic insomnia can produce rapid improvements in sleep, daytime functioning, and psychological variables. Adding ISR to traditional interventions seems to result in a superior treatment response. Citation: Harris J; Lack L; Kemp K; Wright H; Bootzin R. A randomized controlled trial of intensive sleep retraining (ISR): a brief conditioning treatment for chronic insomnia. SLEEP 2012;35(1):49-60. PMID:22215918

Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study

PubMed Central

Li, Jing; Kang, Jian; Wang, Changzheng; Yang, Jing; Wang, Linda; Kottakis, Ioannis; Humphries, Michael

2016-01-01

Purpose Omalizumab is the preferred add-on therapy for patients with moderate-to-severe persistent allergic asthma and has demonstrated efficacy and safety in various ethnicities. This study evaluated the efficacy and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma. Methods This randomized, double-blind, parallel-group, placebo-controlled, phase III study assessed lung function, quality of life, asthma control, and safety of omalizumab after 24-week therapy in Chinese patients (18-75 years of age). Results A total of 616 patients were randomized (1:1) to omalizumab or placebo. The primary endpoint, least squares mean treatment difference (LSM-TD) in morning peak expiratory flow (PEF) (omalizumab vs placebo), at Weeks >20-24 was 8.85 L/min (Full analysis set; P=0.062). Per-protocol analysis set showed significant improvements with LSM-TD of 11.53 L/min in mean mPEF at Weeks >20-24 (P=0.022). The FEV1 % predicted was significantly improved with omalizumab vs placebo from 8 to 24 weeks (after 24-week treatment: LSM-TD=4.12%; P=0.001). At Week 24, a higher proportion of omalizumab-treated patients achieved clinically relevant improvements in standardized AQLQ (58.2% vs 39.3%; LSM=0.51 vs 0.10; P<0.001) and ACQ (49.5% vs 35.5%; LSM=-0.51 vs -0.34; P=0.002) scores vs placebo. Total and nighttime symptom scores reduced significantly with omalizumab vs placebo (LSM-TD=-0.21, P=0.048 and -0.12, P=0.011, respectively). Although the study was not powered to study differences in exacerbation rates (P=0.097), exacerbations in winter months were less frequent in the omalizumab vs placebo group (2 vs 21). Adverse event and severe adverse event rates were comparable between omalizumab and placebo. Conclusions Omalizumab improves lung function, quality of life, and asthma control in Chinese patients with moderate-to-severe persistent allergic asthma and has a good safety profile. PMID:27126725

Early food for future health: a randomized controlled trial evaluating the effect of an eHealth intervention aiming to promote healthy food habits from early childhood.

PubMed

Helle, Christine; Hillesund, Elisabet Rudjord; Omholt, Mona Linge; Øverby, Nina Cecilie

2017-09-20

Childhood overweight and obesity is a global public health challenge. Primary prevention initiatives targeting parents have been called for to encourage a positive feeding environment and healthy eating habits that may lay a good foundation for future health. At the same time, there is a need for interventions which combine accessibility and scalability with cost effectiveness. Today's parents are extensive Internet-users, but only a few randomized controlled trials have investigated the use of Internet to promote healthy eating habits in early childhood. In Early Food for Future Health we have developed and will evaluate an Internet-based tool for parents of children between 6 and 12 months, aiming to increase knowledge about infant nutrition and foster protective feeding behavior. During springtime 2016, parents of children aged between 3 and 5 months were recruited through Norwegian child health centres and announcements on Facebook. After completing the baseline questionnaire, 718 parents were individually randomized to intervention- or control group. The intervention group received monthly emails with links to an age-appropriate web-site when their child was between 6 and 12 months. The control group received ordinary care from the child health centres. The data-collection is ongoing. All participants will be followed up at ages 12 and possibly 24 and 48 months, with questionnaires relating to eating behaviour and feeding practices, food variety and diet quality. Providing guidance and counseling to parents of infants is an important task for health authorities and the public child health services. Early Food for Future health is an intervention focusing on promoting early healthy food-habits which may prevent childhood overweight and obesity. If proven to be effective, Early Food for Future Health can be used by parents and public health nurses for supplementary guidance on feeding practices and diet. This study has the potential to provide greater insight and understanding regarding early parental feeding practices, child eating behavior and the development and efficacy of Internet-based public health interventions. ISRCTN13601567 .

Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study.

PubMed

Li, Jing; Kang, Jian; Wang, Changzheng; Yang, Jing; Wang, Linda; Kottakis, Ioannis; Humphries, Michael; Zhong, Nanshan

2016-07-01

Omalizumab is the preferred add-on therapy for patients with moderate-to-severe persistent allergic asthma and has demonstrated efficacy and safety in various ethnicities. This study evaluated the efficacy and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma. This randomized, double-blind, parallel-group, placebo-controlled, phase III study assessed lung function, quality of life, asthma control, and safety of omalizumab after 24-week therapy in Chinese patients (18-75 years of age). A total of 616 patients were randomized (1:1) to omalizumab or placebo. The primary endpoint, least squares mean treatment difference (LSM-TD) in morning peak expiratory flow (PEF) (omalizumab vs placebo), at Weeks >20-24 was 8.85 L/min (Full analysis set; P=0.062). Per-protocol analysis set showed significant improvements with LSM-TD of 11.53 L/min in mean mPEF at Weeks >20-24 (P=0.022). The FEV1 % predicted was significantly improved with omalizumab vs placebo from 8 to 24 weeks (after 24-week treatment: LSM-TD=4.12%; P=0.001). At Week 24, a higher proportion of omalizumab-treated patients achieved clinically relevant improvements in standardized AQLQ (58.2% vs 39.3%; LSM=0.51 vs 0.10; P<0.001) and ACQ (49.5% vs 35.5%; LSM=-0.51 vs -0.34; P=0.002) scores vs placebo. Total and nighttime symptom scores reduced significantly with omalizumab vs placebo (LSM-TD=-0.21, P=0.048 and -0.12, P=0.011, respectively). Although the study was not powered to study differences in exacerbation rates (P=0.097), exacerbations in winter months were less frequent in the omalizumab vs placebo group (2 vs 21). Adverse event and severe adverse event rates were comparable between omalizumab and placebo. Omalizumab improves lung function, quality of life, and asthma control in Chinese patients with moderate-to-severe persistent allergic asthma and has a good safety profile.

Continued benefits of a technical assistance web site to local tobacco control coalitions during a state budget shortfall.

PubMed

Buller, David B; Young, Walter F; Bettinghaus, Erwin P; Borland, Ron; Walther, Joseph B; Helme, Donald; Andersen, Peter A; Cutter, Gary R; Maloy, Julie A

2011-01-01

A state budget shortfall defunded 10 local tobacco coalitions during a randomized trial but defunded coalitions continued to have access to 2 technical assistance Web sites. To test the ability of Web-based technology to provide technical assistance to local tobacco control coalitions. Randomized 2-group trial with local tobacco control coalitions as the unit of randomization. Local communities (ie, counties) within the State of Colorado. Leaders and members in 34 local tobacco control coalitions funded by the state health department in Colorado. Two technical assistance Web sites: A Basic Web site with text-based information and a multimedia Enhanced Web site containing learning modules, resources, and communication features. Use of the Web sites in minutes, pages, and session and evaluations of coalition functioning on coalition development, conflict resolution, leadership satisfaction, decision-making satisfaction, shared mission, personal involvement, and organization involvement in survey of leaders and members. Coalitions that were defunded but had access to the multimedia Enhanced Web site during the Fully Funded period and after defunding continued to use it (treatment group × funding status × period, F(3,714) = 3.18, P = .0234). Coalitions with access to the Basic Web site had low Web site use throughout and use by defunded coalitions was nearly zero when funding ceased. Members in defunded Basic Web site coalitions reported that their coalitions functioned worse than defunded Enhanced Web site coalitions (coalition development: group × status, F(1,360) = 4.81, P = .029; conflict resolution: group × status, F(1,306) = 5.69, P = .018; leadership satisfaction: group × status, F(1,342) = 5.69, P = .023). The Enhanced Web site may have had a protective effect on defunded coalitions. Defunded coalitions may have increased their capacity by using the Enhanced Web site when fully funded or by continuing to use the available online resources after defunding. Web-based technical assistance with online training and resources may be a good investment when future funding is not ensured.

A Multi-centric, Double-blind, Placebo-controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of Carica papaya Leaf Extract, as Empirical Therapy for Thrombocytopenia associated with Dengue Fever.

PubMed

Kasture, Prabhu Nagnathappa; Nagabhushan, K H; Kumar, Arun

2016-06-01

Dengue is a rapidly expanding global health problem. Approximately 2.5 billion people live in dengue-risk regions with about 100 million new cases each year worldwide. The cumulative dengue diseases burden has attained an unprecedented proportion in recent times with sharp increase in the size of human population at risk. The management of dengue virus infection is essentially supportive and symptomatic and no specific treatment is available for increasing the fallen platelets, which have a significant role in causing the mortality of dengue patient.This study was conducted to evaluate the platelet increasing efficacy of Carica papaya leaf extract (CPLE) in patients with dengue fever (DF). The administration of Carica papaya leaf extract should significantly increase the platelet count in cases of thrombocytopenia associated with dengue, preventing the patient to go in DHF or DSS conditions. A Multi-centric, Double blind, Placebo controlled, Randomized, prospective study was conducted in 300 patients across 5 centres', to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue fever. The subjects were randomized into two groups, as control and intervention group. Both the groups were managed by the standard management guidelines for dengue except steroid administration. In addition to this, the intervention group received CPLE tablet three times daily for five days. All of them were followed daily with platelet monitoring. This study has been registered in the clinical trial registry-India (CTRI Registration number: CTRI/2015/05/005806). The results indicate that CPLE had significant increase(p< 0.01) in the platelet count over the therapy duration, in dengue fever patients, confirming CPLE accelerates the increase in platelet count compared to the control group. There were few adverse events related to GI disturbance like nausea and vomiting which were similar in both groups. Thus this study concluded that Carica papaya leaf extract (CPLE) does significantly increase the platelet count in patients with thrombocytopenia associated with dengue with fewer side effects and good tolerability.

Efficacy and safety of ipragliflozin as an add-on therapy to sitagliptin and metformin in Korean patients with inadequately controlled type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Han, Kyung-Ah; Chon, Suk; Chung, Choon Hee; Lim, Soo; Lee, Kwan-Woo; Baik, SeiHyun; Jung, Chang Hee; Kim, Dong-Sun; Park, Kyong Soo; Yoon, Kun-Ho; Lee, In-Kyu; Cha, Bong-Soo; Sakatani, Taishi; Park, Sumi; Lee, Moon-Kyu

2018-06-04

To evaluate the efficacy and safety of ipragliflozin versus placebo as add-on therapy to metformin and sitagliptin in Korean patients with type 2 diabetes mellitus (T2DM). This double-blind, placebo-controlled, multi-center, phase 3 study was conducted in Korea in 2015-2017. Patients were randomized to receive either ipragliflozin 50 mg/day or placebo once daily for 24 weeks in addition to metformin and sitagliptin. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to end of treatment (EOT). In total, 143 patients were randomized and 139 were included in efficacy analyses (ipragliflozin: 73, placebo: 66). Baseline mean (SD) HbA1c levels were 7.90% (0.69) for ipragliflozin add-on and 7.92% (0.79) for placebo. The corresponding mean (SD) changes from baseline to EOT were -0.79% (0.59) and 0.03% (0.84), respectively, in favor of ipragliflozin (adjusted mean difference: -0.83% [95% CI -1.07 to -0.59%]) (P<0.0001). More ipragliflozin-treated patients than placebo-treated patients achieved HbA1c target levels of <7.0% (44.4% vs. 12.1%) and <6.5% (12.5% vs. 1.5%) at EOT (P<0.05 for both). Fasting plasma glucose, fasting serum insulin, body weight, and homeostatic model assessment for insulin resistance decreased significantly at EOT, in favor of ipragliflozin (adjusted mean difference: -29.55 mg/dL, -1.50 μU/mL, -1.72 kg, and -0.99, respectively) (P<0.05 for all). Adverse event rates were similar between groups (ipragliflozin: 51.4%; placebo: 50.0%). No previously unreported safety concerns were noted. Ipragliflozin add-on to metformin and sitagliptin significantly improved glycemic parameters and demonstrated a good safety profile in Korean patients with inadequately controlled T2DM. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability.

PubMed

de Francisco, Angel L M; Leidig, Michael; Covic, Adrian C; Ketteler, Markus; Benedyk-Lorens, Ewa; Mircescu, Gabriel M; Scholz, Caecilia; Ponce, Pedro; Passlick-Deetjen, Jutta

2010-11-01

Phosphate binders are required to control serum phosphorus in dialysis patients. A phosphate binder combining calcium and magnesium offers an interesting therapeutic option. This controlled randomized, investigator-masked, multicentre trial investigated the effect of calcium acetate/magnesium carbonate (CaMg) on serum phosphorus levels compared with sevelamer hydrochloride (HCl). The study aim was to show non-inferiority of CaMg in lowering serum phosphorus levels into Kidney Disease Outcome Quality Initiative (K/DOQI) target level range after 24 weeks. Three hundred and twenty-six patients from five European countries were included. After a phosphate binder washout period, 255 patients were randomized in a 1:1 fashion. Two hundred and four patients completed the study per protocol (CaMg, N = 105; dropouts N = 18; sevelamer-HCl, N = 99; dropouts N = 34). Patient baseline characteristics were similar in both groups. Serum phosphorus levels had decreased significantly with both drugs at week 25, and the study hypothesis of CaMg not being inferior to sevelamer-HCl was confirmed. The area under the curve for serum phosphorus (P = 0.0042) and the number of visits above K/DOQI (≤1.78 mmol/L, P = 0.0198) and Kidney disease: Improving global outcomes (KDIGO) targets (≤1.45 mmol/L, P = 0.0067) were significantly lower with CaMg. Ionized serum calcium did not differ between groups; total serum calcium increased in the CaMg group (treatment difference 0.0477 mmol/L; P = 0.0032) but was not associated with a higher risk of hypercalcaemia. An asymptomatic increase in serum magnesium occurred in CaMg-treated patients (treatment difference 0.2597 mmol/L, P < 0.0001). There was no difference in the number of patients with adverse events. CaMg was non-inferior to the comparator at controlling serum phosphorus levels at Week 25. There was no change in ionized calcium; there was minimal increase in total serum calcium and a small increase in serum magnesium. It had a good tolerability profile and thus may represent an effective treatment of hyperphosphataemia.

Record statistics of financial time series and geometric random walks

NASA Astrophysics Data System (ADS)

Sabir, Behlool; Santhanam, M. S.

2014-09-01

The study of record statistics of correlated series in physics, such as random walks, is gaining momentum, and several analytical results have been obtained in the past few years. In this work, we study the record statistics of correlated empirical data for which random walk models have relevance. We obtain results for the records statistics of select stock market data and the geometric random walk, primarily through simulations. We show that the distribution of the age of records is a power law with the exponent α lying in the range 1.5≤α≤1.8. Further, the longest record ages follow the Fréchet distribution of extreme value theory. The records statistics of geometric random walk series is in good agreement with that obtained from empirical stock data.

Effects of medication reviews performed by a physician on treatment with fracture-preventing and fall-risk-increasing drugs in older adults with hip fracture-a randomized controlled study.

PubMed

Sjöberg, Christina; Wallerstedt, Susanna M

2013-09-01

To investigate whether medication reviews increase treatment with fracture-preventing drugs and decrease treatment with fall-risk-increasing drugs. Randomized controlled trial (1:1). Departments of orthopedics, geriatrics, and medicine at Sahlgrenska University Hospital, Gothenburg, Sweden. One hundred ninety-nine consecutive individuals with hip fracture aged 65 and older. Medication reviews, based on assessments of risks of falls and fractures, regarding fracture-preventing and fall-risk-increasing drugs, performed by a physician, conveyed orally and in written form to hospital physicians during the hospital stay, and to general practitioners after discharge. Primary outcomes were changes in treatment with fracture-preventing and fall-risk-increasing drugs 12 months after discharge. Secondary outcomes were falls, fractures, deaths, and physicians' attitudes toward the intervention. At admission, 26% of intervention and 29% of control participants were taking fracture-preventing drugs, and 12% and 11%, respectively, were taking bone-active drugs, predominantly bisphosphonates. After 12 months, 77% of intervention and 58% of control participants were taking fracture-preventing drugs (P = .01), and 29% and 15%, respectively, were taking bone-active drugs (P = .04). Mean number of fall-risk-increasing drugs per participants was 3.1 (intervention) and 3.1 (control) at admission and 2.9 (intervention) and 3.1 (control) at 12 months (P = .62). No significant differences in hard endpoints were found. The responding physicians (n = 65) appreciated the intervention; on a scale from 1 (very bad) to 6 (very good), the median rating was 5 (interquartile range (IQR) 4-6) for the oral part and 5 (IQR 4-5.5) for the text part. Medication reviews performed and conveyed by a physician increased treatment with fracture-preventing drugs but did not significantly decrease treatment with fall-risk-increasing drugs in older adults with hip fracture. Prescribing physicians appreciated this intervention. © 2013, Copyright the Authors Journal compilation © 2013, The American Geriatrics Society.

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

Autoshaping, random control, and omission training in the rat1

PubMed Central

Locurto, Charles; Terrace, H. S.; Gibbon, John

1976-01-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping. PMID:16811960

Autoshaping, random control, and omission training in the rat.

PubMed

Locurto, C; Terrace, H S; Gibbon, J

1976-11-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

Factors associated with glycemic control among diabetic adult out-patients in Northeast Ethiopia.

PubMed

Fiseha, Temesgen; Alemayehu, Ermiyas; Kassahun, Wongelawit; Adamu, Aderaw; Gebreweld, Angesom

2018-05-18

The aim of this study was to determine the status of glycemic control and identify factors associated with poor glycemic control among diabetic out-patients. A hospital based cross-sectional study was conducted among randomly selected 384 (126 type 1 and 258 type 2) diabetic adults attending a hospital in Northeast Ethiopia from January 1 to April 30, 2017. Of the total participants, 70.8% had poor status of glycemic control (defined as mean fasting blood glucose level above 130 mg/dl). In the multivariate analysis, rural residence (AOR = 2.61, 95% CI 1.37-4.96), low educational level (AOR = 7.10, 95% CI 2.94-17.17) and longer duration of diabetes (AOR = 2.20, 95% CI 1.18-4.08) were significantly associated with increased odds of poor glycemic control. Moreover, merchants (AOR = 3.39, 95% CI 1.16-9.96) were significantly more likely to have poor glycemic control compared to government employee. Diabetic patients receiving oral anti-diabetics (AOR = 5.12, 95% CI 2.10-12.52) or insulin (AOR = 3.26, 95% CI 1.26-8.48) were more likely to be poorly controlled. These results highlight the needed for appropriate management of patients focusing on associated factors identified for poor glycemic control to maintain good glycemic control and improve adverse outcomes of the disease in this study setting.

Distributive routing and congestion control in wireless multihop ad hoc communication networks

NASA Astrophysics Data System (ADS)

Glauche, Ingmar; Krause, Wolfram; Sollacher, Rudolf; Greiner, Martin

2004-10-01

Due to their inherent complexity, engineered wireless multihop ad hoc communication networks represent a technological challenge. Having no mastering infrastructure the nodes have to selforganize themselves in such a way that for example network connectivity, good data traffic performance and robustness are guaranteed. In this contribution the focus is on routing and congestion control. First, random data traffic along shortest path routes is studied by simulations as well as theoretical modeling. Measures of congestion like end-to-end time delay and relaxation times are given. A scaling law of the average time delay with respect to network size is revealed and found to depend on the underlying network topology. In the second step, a distributive routing and congestion control is proposed. Each node locally propagates its routing cost estimates and information about its congestion state to its neighbors, which then update their respective cost estimates. This allows for a flexible adaptation of end-to-end routes to the overall congestion state of the network. Compared to shortest-path routing, the critical network load is significantly increased.

Flight performance, energetics and water turnover of tippler pigeons with a harness and dorsal load

USGS Publications Warehouse

Gessaman, J.A.; Workman, G.W.; Fuller, M.R.

1991-01-01

We measured carbon dioxide production and water efflux of 12 tippler pigeons (Columba spp.) during seven experimental flights using the doubly labeled water (DLW) method. Prior to the experiment birds were randomly assigned to one of two groups. One group flew as controls (no load or harness) on all seven flights. The other group wore a harness on two flights, a dorsal load/harness package (weighing about 5% of a bird's mass) on two flights, and they were without a load in three flights. Flight duration of pigeons with only a harness and with a dorsal load/harness package was 21 and 26% less, respectively, than the controls. Pigeons wearing a harness, or wearing a dorsal load/harness package lost water 50-90%, and 57-100% faster, respectively, than control pigeons. The mean CO2 production of pigeons wearing a harness or a load/harness package was not significantly different than pigeons without a harness or load. The small sample sizes and large variability in DLW measuremets precluded a good test of the energetic cost of flying with a harness and dorsal load.

Flight performance energetics and water turnovers of Tippler Pigeons with a harness and doorsal load

USGS Publications Warehouse

Gessaman, James A.; Workman, Gar W.; Fuller, Mark R.

1991-01-01

We measured carbon dioxide production and water efflux of 12 tippler pigeons (Columba spp.) during seven experimental flights using the doubly labeled water (DLW) method. Prior to the experiment birds were randomly assigned to one of two groups. One group flew as controls (no load or harness) on all seven flights. The other group wore a harness on two flights, a dorsal load/harness package (weighing about 5% of a birda??s mass) on two flights, and they were without a load in three flights. Plight duration of pigeons with only a harness and with a dorsal load/harness package was 21 and 26% less, respectively, than the controls. Pigeons wearing a harness, or wearing a dorsal load/harness package lost water 50-90%, and 57-100% faster, respectively, than control pigeons. The mean CO, production of pigeons wearing a harness or a load/harness package was not significantly different than pigeons without a harness or load. The small sample sizes and large variability in DLW measurements precluded a good test of the energetic cost of flying with a harness and dorsal load.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial.

PubMed

Hollands, Kristen L; Pelton, Trudy A; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M; Wing, Alan M; Tyson, Sarah F; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M

2015-01-01

Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services. Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments. Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Clinicaltrials.gov NCT01600391.

Working memory training in survivors of pediatric cancer: a randomized pilot study.

PubMed

Hardy, Kristina K; Willard, Victoria W; Allen, Taryn M; Bonner, Melanie J

2013-08-01

Survivors of pediatric brain tumors and acute lymphoblastic leukemia (ALL) are at increased risk for neurocognitive deficits, but few empirically supported treatment options exist. We examined the feasibility and preliminary efficacy of a home-based, computerized working memory training program, CogmedRM, with survivors of childhood cancer. Survivors of brain tumors or ALL (n = 20) with identified deficits in attention and/or working memory were randomized to either the success-adapted computer intervention or a non-adaptive, active control condition. Specifically, children in the adaptive condition completed exercises that became more challenging with each correct trial, whereas those in the non-adaptive version trained with exercises that never increased in difficulty. All participants were asked to complete 25 training sessions at home, with weekly, phone-based coaching support. Brief assessments were completed pre-intervention and post-intervention; outcome measures included both performance-based and parent-report measures of working memory and attention. Eighty-five percent of survivors were compliant with the intervention, with no adverse events reported. After controlling for baseline intellectual functioning, survivors who completed the intervention program evidenced significant post-training improvements in their visual working memory and in parent-rated learning problems compared with those in the active control group. No differences in verbal working memory functioning were evident between groups, however. Home-based, computerized cognitive training demonstrates good feasibility and acceptability in our sample. Children with higher intellectual functioning at baseline appeared to benefit more from the training, although further study is needed to clarify the strength, scope, and particularly the generalizability of potential treatment effects. Copyright © 2012 John Wiley & Sons, Ltd.

Physical activity in prevention and treatment of the metabolic syndrome.

PubMed

Lakka, Timo A; Laaksonen, David E

2007-02-01

Randomised controlled trials have shown that exercise training has a mild or moderate favourable effect on many metabolic and cardiovascular risk factors that constitute or are related to the metabolic syndrome (MetS). Epidemiological studies suggest that regular physical activity prevents type 2 diabetes, cardiovascular disease, and premature mortality in large part through these risk factors. Although randomized controlled trials with the prevention or treatment of the MetS as the main outcome have not been published, several large randomized controlled trials provide strong evidence that favourable lifestyle changes, including regular physical activity, are effective in the prevention of type 2 diabetes in individuals who are overweight and have impaired glucose tolerance. Compliance with the current recommendations to increase the total volume of moderate-intensity physical activity and to maintain good cardiorespiratory and muscular fitness appears to markedly decrease the likelihood of developing the MetS, especially in high-risk groups. Walking is the most common form of physical activity--it improves health in many ways and is generally safe. Therefore, brisk walking for at least 30 min daily can be recommended as the principal form of physical activity at the population level. If there are no contraindications, more vigorous physical exercise or resistance training should also be considered to obtain additional health benefits. Unstructured and low-intensity physical activity may also decrease the likelihood of developing the MetS, especially when substituted for sedentary behaviours such as watching television. The measurement of maximal oxygen consumption may provide an efficient means to target even individuals with relatively few metabolic risk factors who may benefit from more intensive intervention.