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Sample records for randomized controlled european

  1. Effects of a Web-Based Personalized Intervention on Physical Activity in European Adults: A Randomized Controlled Trial

    PubMed Central

    Celis-Morales, Carlos; Fallaize, Rosalind; Macready, Anna L; Kolossa, Silvia; Woolhead, Clara; O'Donovan, Clare B; Forster, Hannah; Navas-Carretero, Santiago; San-Cristobal, Rodrigo; Lambrinou, Christina-Paulina; Moschonis, George; Surwillo, Agnieszka; Godlewska, Magdalena; Goris, Annelies; Hoonhout, Jettie; Drevon, Christian A; Manios, Yannis; Traczyk, Iwona; Walsh, Marianne C; Gibney, Eileen R; Brennan, Lorraine; Martinez, J Alfredo; Lovegrove, Julie A; Gibney, Michael J; Daniel, Hannelore; Mathers, John C; Saris, Wim HM

    2015-01-01

    Background The high prevalence of physical inactivity worldwide calls for innovative and more effective ways to promote physical activity (PA). There are limited objective data on the effectiveness of Web-based personalized feedback on increasing PA in adults. Objective It is hypothesized that providing personalized advice based on PA measured objectively alongside diet, phenotype, or genotype information would lead to larger and more sustained changes in PA, compared with nonpersonalized advice. Methods A total of 1607 adults in seven European countries were randomized to either a control group (nonpersonalized advice, Level 0, L0) or to one of three personalized groups receiving personalized advice via the Internet based on current PA plus diet (Level 1, L1), PA plus diet and phenotype (Level 2, L2), or PA plus diet, phenotype, and genotype (Level 3, L3). PA was measured for 6 months using triaxial accelerometers, and self-reported using the Baecke questionnaire. Outcomes were objective and self-reported PA after 3 and 6 months. Results While 1270 participants (85.81% of 1480 actual starters) completed the 6-month trial, 1233 (83.31%) self-reported PA at both baseline and month 6, but only 730 (49.32%) had sufficient objective PA data at both time points. For the total cohort after 6 months, a greater improvement in self-reported total PA (P=.02) and PA during leisure (nonsport) (P=.03) was observed in personalized groups compared with the control group. For individuals advised to increase PA, we also observed greater improvements in those two self-reported indices (P=.006 and P=.008, respectively) with increased personalization of the advice (L2 and L3 vs L1). However, there were no significant differences in accelerometer results between personalized and control groups, and no significant effect of adding phenotypic or genotypic information to the tailored feedback at month 3 or 6. After 6 months, there were small but significant improvements in the objectively

  2. Effect and Process Evaluation of a Cluster Randomized Control Trial on Water Intake and Beverage Consumption in Preschoolers from Six European Countries: The ToyBox-Study

    PubMed Central

    Pinket, An-Sofie; Van Lippevelde, Wendy; De Bourdeaudhuij, Ilse; Deforche, Benedicte; Cardon, Greet; Androutsos, Odysseas; Koletzko, Berthold; Moreno, Luis A.; Socha, Piotr; Iotova, Violeta; Manios, Yannis; De Craemer, Marieke

    2016-01-01

    Background Within the ToyBox-study, a kindergarten-based, family-involved intervention was developed to prevent overweight and obesity in European preschoolers, targeting four key behaviours related to early childhood obesity, including water consumption. The present study aimed to examine the effect of the ToyBox-intervention (cluster randomized controlled trial) on water intake and beverage consumption in European preschoolers and to investigate if the intervention effects differed by implementation score of kindergartens and parents/caregivers. Method A sample of 4964 preschoolers (4.7±0.4 years; 51.5% boys) from six European countries (Belgium, Bulgaria, Germany, Greece, Poland, Spain) was included in the data analyses. A standardized protocol was used and parents/caregivers filled in socio-demographic data and a food-frequency questionnaire. To assess intervention effects, multilevel repeated measures analyses were conducted for the total sample and for the six country-specific samples. Based on the process evaluation questionnaire of teachers and parents/caregivers, an implementation score was constructed. To assess differences in water intake and beverage consumption by implementation score in the total sample, multilevel repeated measures analyses were performed. Results Limited intervention effects on water intake from beverages and overall beverage consumption were found. However, important results were found on prepacked fruit juice consumption, with a larger decrease in the intervention group compared to the control group. However, also a decline in plain milk consumption was found. Implementation scores were rather low in both kindergartens and parents/caregivers. Nevertheless, more favorable effects on beverage choices were found in preschoolers whose parents/caregivers and kindergarten teachers had higher implementation scores compared to those with lower implementation scores. Conclusion The ToyBox-intervention can provide the basis for the

  3. Cluster Randomized Controlled Trial

    PubMed Central

    Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

    2015-01-01

    Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

  4. Neuropsychological Outcome of Children Treated for Standard Risk Medulloblastoma in the PNET4 European Randomized Controlled Trial of Hyperfractionated Versus Standard Radiation Therapy and Maintenance Chemotherapy

    SciTech Connect

    Câmara-Costa, Hugo; Resch, Anika; Kieffer, Virginie; Lalande, Clémence; Poggi, Geraldina; Kennedy, Colin; Bull, Kim; Calaminus, Gabriele; Grill, Jacques; Doz, François; Rutkowski, Stefan; Massimino, Maura; Kortmann, Rolf-Dieter; Lannering, Birgitta; Dellatolas, Georges; Chevignard, Mathilde

    2015-08-01

    Purpose: In the European HIT-SIOP PNET4 randomized controlled trial, children with standard risk medulloblastoma were allocated to hyperfractionated radiation therapy (HFRT arm, including a partially focused boost) or standard radiation therapy (STRT arm), followed, in both arms, by maintenance chemotherapy. Event-free survival was similar in both arms. Previous work showed that the HFRT arm was associated with worse growth and better questionnaire-based executive function, especially in children <8 years of age at diagnosis. Therefore, the aim of this study was to compare performance-based cognitive outcomes between treatment arms. Methods and Materials: Neuropsychological data were collected prospectively in 137 patients. Using the Wechsler Intelligence Scales, Kaufman Assessment Battery for Children, and Raven's Progressive Matrices, we estimated full-scale intelligence quotient (FSIQ) and, when available, verbal IQ (VIQ), performance IQ (PIQ), working memory index (WMI), and processing speed index (PSI). Results: Among the 137 participants (HFRT arm n=71, STRT arm n=66, 63.5% males), mean (±SD) ages at diagnosis and assessment respectively were 9.3 (±3.2) years of age (40.8% < 8 years of age at diagnosis) and 14.6 (±4.3) years of age. Mean (±SD) FSIQ was 88 (±19), and mean intergroup difference was 3.88 (95% confidence interval: −2.66 to 10.42, P=.24). No significant differences were found in children >8 years of age at diagnosis. In children <8 years of age at diagnosis, a marginally significant trend toward higher VIQ was found in those treated in the HFRT arm; a similar trend was found for PSI but not for PIQ, WMI, or FSIQ (mean intergroup differences were: 12.02 for VIQ [95% CI: 2.37-21.67; P=.02]; 3.77 for PIQ [95% CI: −5.19 to 12.74; P>.10]; 5.20 for WMI [95% CI: −2.07 to 12.47; P>.10]; 10.90 for PSI [95% CI: −1.54 to 23.36; P=.08]; and 5.28 for FSIQ [95% CI: −4.23 to 14.79; P>.10]). Conclusions: HFRT was associated with marginally

  5. Control theory for random systems

    NASA Technical Reports Server (NTRS)

    Bryson, A. E., Jr.

    1972-01-01

    A survey is presented of the current knowledge available for designing and predicting the effectiveness of controllers for dynamic systems which can be modeled by ordinary differential equations. A short discussion of feedback control is followed by a description of deterministic controller design and the concept of system state. The need for more realistic disturbance models led to the use of stochastic process concepts, in particular the Gauss-Markov process. A compensator controlled system, with random forcing functions, random errors in the measurements, and random initial conditions, is treated as constituting a Gauss-Markov random process; hence the mean-square behavior of the controlled system is readily predicted. As an example, a compensator is designed for a helicopter to maintain it in hover in a gusty wind over a point on the ground.

  6. European randomized lung cancer screening trials: Post NLST.

    PubMed

    Field, John K; van Klaveren, Rob; Pedersen, Jesper H; Pastorino, Ugo; Paci, Eugino; Becker, Nikolauss; Infante, Maurizo; Oudkerk, Matthijs; de Koning, Harry J

    2013-10-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects of their trials at August 2010, which included 32,000 people, inclusion of UKLS pilot trial will reach 36,000. An interim analysis is planned, but the final mortality data testing is scheduled for 2015. PMID:23893464

  7. Contributions of the European trials (European randomized screening group) in computed tomography lung cancer screening.

    PubMed

    Heuvelmans, Marjolein A; Vliegenthart, Rozemarijn; Oudkerk, Matthijs

    2015-03-01

    Lung cancer is the leading cause of cancer-related death worldwide. In 2011, the largest lung cancer screening trial worldwide, the US National Lung Screening Trial, published a 20% decrease in lung cancer-specific mortality in the computed tomography (CT)-screened group, compared with the group screened by chest x-ray. On the basis of this trial, different US guidelines recently have recommended CT lung cancer screening. However, several questions regarding the implementation of lung cancer screening need to be answered. In Europe, several lung cancer screening trials are ongoing. It is planned to pool the results of the lung cancer screening trials in European randomized lung cancer CT screening (EUCT). By pooling of the data, EUCT hopes to be able to provide additional information for the discussion of some important issues regarding the implementation of lung cancer screening by low-dose CT, including: the determination of the optimal screen population, the comparison between a volume-based and diameter-based nodule management protocol, and the determination of optimal screen intervals.

  8. European healthcare policies for controlling drug expenditure.

    PubMed

    Ess, Silvia M; Schneeweiss, Sebastian; Szucs, Thomas D

    2003-01-01

    In the last 20 years, expenditures on pharmaceuticals - as well as total health expenditures - have grown faster than the gross national product in all European countries. The aim of this paper was to review policies that European governments apply to reduce or at least slow down public expenditure on pharmaceutical products. Such policies can target the industry, the wholesalers and retailers, prescribers, and patients. The objectives of pharmaceutical policies are multidimensional and must take into account issues relating to public health, public expenditure and industrial incentives. Both price levels and consumption patterns determine the level of total drug expenditure in a particular country, and both factors vary greatly across countries. Licensing and pricing policies intend to influence the supply side. Three types of pricing policies can be recognised: product price control, reference pricing and profit control. Profit control is mainly used in the UK. Reference pricing systems were first used in Germany and The Netherlands and are being considered in other countries. Product price control is still the most common method for establishing the price of drugs. For the aim of fiscal consolidation, price-freeze and price-cut measures have been frequently used in the 1980s and 1990s. They have affected all types of schemes. For drug wholesalers and retailers, most governments have defined profit margins. The differences in price levels as well as the introduction of a Single European Pharmaceutical Market has led to the phenomenon of parallel imports among member countries of the European Union. This may be facilitated by larger and more powerful wholesalers and the vertical integration between wholesalers and retailers. To control costs, the use of generic drugs is encouraged in most countries, but only few countries allow pharmacists to substitute generic drugs for proprietary brands. Various interventions are used to reduce the patients' demand for drugs by

  9. Reporting Randomized Controlled Trials in Education

    ERIC Educational Resources Information Center

    Mayo-Wilson, Evan; Grant, Sean; Montgomery, Paul

    2014-01-01

    Randomized controlled trials (RCTs) are increasingly used to evaluate programs and interventions in order to inform education policy and practice. High quality reports of these RCTs are needed for interested readers to understand the rigor of the study, the interventions tested, and the context in which the evaluation took place (Mayo-Wilson et…

  10. Recruiting Participants for Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Gallagher, H. Alix; Roschelle, Jeremy; Feng, Mingyu

    2014-01-01

    The objective of this study was to look across strategies used in a wide range of studies to build a framework for researchers to use in conceptualizing the recruitment process. This paper harvests lessons learned across 19 randomized controlled trials in K-12 school settings conducted by a leading research organization to identify strategies that…

  11. A European multicentre and open-label controlled randomized trial to evaluate the efficacy of Sequential treatment with TAcrolimus–Rituximab versus steroids plus cyclophosphamide in patients with primary MEmbranous Nephropathy: the STARMEN study

    PubMed Central

    Rojas-Rivera, Jorge; Fernández-Juárez, Gema; Ortiz, Alberto; Hofstra, Julia; Gesualdo, Loreto; Tesar, Vladimir; Wetzels, Jack; Segarra, Alfons; Egido, Jesus; Praga, Manuel

    2015-01-01

    Background Patients with primary membranous nephropathy (MN) and persistent nephrotic syndrome have a high risk of progression to end-stage renal disease. The Ponticelli protocol (steroids with alkylating agents) is the most effective immunosuppressive therapy for this condition, but it has severe adverse effects. Tacrolimus and rituximab have demonstrated efficacy for remission of nephrotic syndrome in MN with a safer profile. However, the published evidence is largely based on small or short-term observational studies, historical cohorts, comparisons with conservative therapy or clinical trials without appropriate control groups, and there is no head-to-head comparison with the Ponticelli protocol. Methods The STARMEN randomized clinical trial will compare the efficacy of sequential tacrolimus–rituximab therapy with a modified Ponticelli protocol (steroids plus cyclophosphamide). The trial will also evaluate the role of antibodies against the M-type phospholipase A2 receptor (anti-PLA2R) and other antibodies as markers of response to treatment and long-term prognosis. Results The trial has already started with 23 patients having been enrolled as of 1 April 2015, an estimated 21.7% of the estimated sample. PMID:26413273

  12. A European prospective, randomized placebo-controlled doubleblind Study on the efficacy and safety of Dr Michaels® (also branded as Soratinex®) product family for stable chronic plaque psoriasis.

    PubMed

    França, K; Hercogovấ, J; Fioranelli, M; Gianfaldoni, S; Chokoeva, A A; Tchernev, G; Wollina, U; Tirant, M; Novotny, F; Roccia, M G; Maximov, G K; Lotti, T

    2016-01-01

    Psoriasis is a chronic, inflammatory, recurrent, genetically determined dermatitis that affects the skin and joints. Many patients affected by this condition seek alternatives and complementary treatment options such as herbal medicines. In order to establish the safety of these products, trials, according to medical standards should be performed to provide the highest quality of data. The aim of this study was to assess the efficacy and safety of an Australian series of herbal skincare products [Dr. Michaels® (Soratinex®) skin-care products for psoriasis] for the management of stable chronic plaque psoriasis. We studied 142 patients (68 females and 74 males) with mild to moderate, stable, chronic plaque psoriasis and they were randomly assigned to either verum or control group. Exclusion criteria were: severe psoriasis, arthropathic psoriasis, intertriginous psoriasis, palmoplantar psoriasis, use of any antipsoriatic treatment and any medication which could influence or interfere with the course of the disease. Both groups consisted of a cleansing gel, an ointment and an oil blend (skin conditioner), packed in neutral bottles, used twice daily for all lesions except the scalp, for 8 weeks. As control products, we used compositions of well-known neutral ointments and medicinal bathing oil. Assessment, using the Psoriasis Activity Severity Index (PASI) scores, was done before treatment and after 2, 4, 6 and 8 weeks. Patient improvement was determined by the percentage reduction of the PASI scores. Statistical analysis was carried out using the Mann-Whitney-U Test with SPSS for Windows. Our investigation demonstrates that complementary methods can play a role in dermatologic therapy as long as they undergo standardised clinical trials and fulfil the basic requirements such as product safety and quality assurance. This study shows that Dr Michaels (Soratinex®) herbal skin-care products improve mild to moderate stable chronic plaque psoriasis significantly. PMID

  13. A European prospective, randomized placebo-controlled doubleblind Study on the efficacy and safety of Dr Michaels® (also branded as Soratinex®) product family for stable chronic plaque psoriasis.

    PubMed

    França, K; Hercogovấ, J; Fioranelli, M; Gianfaldoni, S; Chokoeva, A A; Tchernev, G; Wollina, U; Tirant, M; Novotny, F; Roccia, M G; Maximov, G K; Lotti, T

    2016-01-01

    Psoriasis is a chronic, inflammatory, recurrent, genetically determined dermatitis that affects the skin and joints. Many patients affected by this condition seek alternatives and complementary treatment options such as herbal medicines. In order to establish the safety of these products, trials, according to medical standards should be performed to provide the highest quality of data. The aim of this study was to assess the efficacy and safety of an Australian series of herbal skincare products [Dr. Michaels® (Soratinex®) skin-care products for psoriasis] for the management of stable chronic plaque psoriasis. We studied 142 patients (68 females and 74 males) with mild to moderate, stable, chronic plaque psoriasis and they were randomly assigned to either verum or control group. Exclusion criteria were: severe psoriasis, arthropathic psoriasis, intertriginous psoriasis, palmoplantar psoriasis, use of any antipsoriatic treatment and any medication which could influence or interfere with the course of the disease. Both groups consisted of a cleansing gel, an ointment and an oil blend (skin conditioner), packed in neutral bottles, used twice daily for all lesions except the scalp, for 8 weeks. As control products, we used compositions of well-known neutral ointments and medicinal bathing oil. Assessment, using the Psoriasis Activity Severity Index (PASI) scores, was done before treatment and after 2, 4, 6 and 8 weeks. Patient improvement was determined by the percentage reduction of the PASI scores. Statistical analysis was carried out using the Mann-Whitney-U Test with SPSS for Windows. Our investigation demonstrates that complementary methods can play a role in dermatologic therapy as long as they undergo standardised clinical trials and fulfil the basic requirements such as product safety and quality assurance. This study shows that Dr Michaels (Soratinex®) herbal skin-care products improve mild to moderate stable chronic plaque psoriasis significantly.

  14. Education in infection control: A need for European certification.

    PubMed

    Zingg, W; Mutters, N T; Harbarth, S; Friedrich, A W

    2015-12-01

    Healthcare-associated infections are common adverse events in acute-care medicine, causing significant morbidity and mortality. There has been a significant increase in the commitment to infection prevention and control (IPC) among European countries in recent years. However, there is still heterogeneity in training opportunities and IPC qualifications. The European Union promotes the harmonization of IPC strategies among member states. The European Centre for Disease Prevention and Control (ECDC)-commissioned Training in Infection Control in Europe project sets the stage for harmonization of IPC activities in Europe by issuing a list of core competencies for IPC professionals. European certification of IPC training and professionals would be the next logical step, which must be achieved by close collaboration between different stakeholders in Europe such as the ECDC, the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), the European Union of Medical Specialities, and the national IPC societies. Therefore, the ESCMID has launched the new European Committee on Infection Control to take the lead in the implementation of a European (board) certificate for IPC professionals. PMID:26363403

  15. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  16. Meta-analyses of randomized controlled trials.

    PubMed

    Sacks, H S; Berrier, J; Reitman, D; Ancona-Berk, V A; Chalmers, T C

    1987-02-19

    A new type of research, termed meta-analysis, attempts to analyze and combine the results of previous reports. We found 86 meta-analyses of reports of randomized controlled trials in the English-language literature. We evaluated the quality of these meta-analyses, using a scoring method that considered 23 items in six major areas--study design, combinability, control of bias, statistical analysis, sensitivity analysis, and application of results. Only 24 meta-analyses (28 percent) addressed all six areas, 31 (36 percent) addressed five, 25 (29 percent) addressed four, 5 (6 percent) addressed three, and 1 (1 percent) addressed two. Of the 23 individual items, between 1 and 14 were addressed satisfactorily (mean +/- SD, 7.7 +/- 2.7). We conclude that an urgent need exists for improved methods in literature searching, quality evaluation of trials, and synthesizing of the results.

  17. Randomized Control Trial of Composite Cuspal Restorations

    PubMed Central

    Fennis, W.M.; Kuijs, R.H.; Roeters, F.J.; Creugers, N.H.; Kreulen, C.M.

    2014-01-01

    The objective of this randomized control trial was to compare the five-year clinical performance of direct and indirect resin composite restorations replacing cusps. In 157 patients, 176 restorations were made to restore maxillary premolars with Class II cavities and one missing cusp. Ninety-two direct and 84 indirect resin composite restorations were placed by two operators, following a strict protocol. Treatment technique and operator were assigned randomly. Follow-up period was at least 4.5 yrs. Survival rates were determined with time to reparable failure and complete failure as endpoints. Kaplan-Meier five-year survival rates were 86.6% (SE 0.27%) for reparable failure and 87.2% (SE 0.27%) for complete failure. Differences between survival rates of direct and indirect restorations [89.9% (SE 0.34%) vs. 83.2% (SE 0.42%) for reparable failure and 91.2% (SE 0.32%) vs. 83.2% (SE 0.42%) for complete failure] were not statistically significant (p = .23 for reparable failure; p = .15 for complete failure). Mode of failure was predominantly adhesive. The results suggest that direct and indirect techniques provide comparable results over the long term (trial registration number: ISRCTN29200848). PMID:24155264

  18. Pediatric Nephrologists’ Beliefs Regarding Randomized Controlled Trials

    PubMed Central

    Wightman, Aaron G; Oron, Assaf P; Symons, Jordan M; Flynn, Joseph T

    2014-01-01

    Background Pediatrics and pediatric nephrology lag behind adult medicine in producing randomized controlled trials (RCTs). Physician attitudes have been shown to play a significant role in RCT enrollment. Methods We surveyed members of the American Society of Pediatric Nephrology regarding beliefs about RCTs and factors influencing decisions to recommend RCT enrollment. Regression analyses were used to identify effects of variables on an aggregate score summarizing attitudes toward RCTs. Results 130 replies were received. 66% had enrolled patients in RCTs. Respondents in practice >15 years were more likely to have recruited a patient to a RCT than those in practice <5 years. Respondents were more willing to recommend RCT enrollment if the study was multicenter, patients were sicker or had a poorer prognosis, or if the parent or participant received a financial incentive versus the provider. In multiple regression analysis, history of enrolling patients in a RCT was the only significant predictor of higher aggregate RCT-friendly attitude. Conclusions Many pediatric nephrologists have never enrolled a patient in a RCT, particularly those in practice <5 years. Respondents who have not enrolled patients in RCTs have a less RCT-friendly attitude. Provision of improved training and resources might increase participation of junior providers in RCTs. PMID:24379023

  19. Mapping communicable disease control in the European union.

    PubMed

    Elliott, Heather A; Jones, David K; Greer, Scott L

    2012-12-01

    Understanding both the current performance of communicable disease control in Europe and the scale of the differences among systems is crucial to understanding its present performance and possible Europeanization. We attempt to identify the structure of authority in communicable disease control in each European Union (EU) member state. The primary sources of information were the competent bodies list posted on the European Centre for Disease Prevention and Control website and the Health in Transition reports produced by the European Observatory on Health Systems and Policies. Three key patterns emerge to answer the question of who does what. First, the landscape is full and crowded, with many actors involved. Second, the landscape is highly fragmented, with many organizations performing overlapping functions in each country. Third, regional patterns describe which types of organizations are assigned which functions. These full, fragmented, and regionally disparate systems show no signs of constituting a shared model. As a result, if there is an EU model of communicable disease control today, it is at most an aspiration. PMID:22899840

  20. European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP): a randomized trial.

    PubMed

    Landolfi, R; Marchioli, R

    1997-01-01

    Thrombotic complications characterize the clinical course of polycythemia vera (PV) and represent the main cause of morbidity and mortality. However, uncertainty still exists as to the benefit/risk ratio of aspirin prophylaxis in this setting. In vivo platelet biosynthesis of thromboxane A2 is enhanced and can be suppressed by low-dose aspirin in PV, thus providing a rationale for assessing the efficacy and safety of a low-dose aspirin regimen in these patients. The Gruppo Italiano Studio Policitemia Vera has recently performed a pilot study on 112 patients randomized to receive aspirin, 40 mg daily, or placebo and followed for 16 +/- 6 months (mean +/- SD). This study showed that low-dose aspirin is well tolerated in PV patients, and that a large-scale efficacy trial is feasible in this setting. In this article we report the protocol of the European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP) study, which is a randomized trial designed to assess the risk/benefit ratio of low-dose aspirin in PV. To estimate the size and the follow-up duration required for the ECLAP trial, a retrospective analysis of the clinical epidemiology of a large PV population has recently been completed by the Gruppo Italiano Studio Policitemia Vera. On this basis, approximately 3500 patients will be enrolled in the ECLAP study with a follow-up of 3 to 4 years. The uncertainty principle will be used as the main eligibility criterion: Polycythemic patients of any age, having no clear indication for or contraindication to aspirin treatment, will be randomized in a double-blind fashion to receive oral aspirin (100 mg daily) or placebo. According to current therapeutic recommendations, the basic treatment of randomized patients should be aimed at maintaining the hematocrit value < or = 45% in subjects aged < or = 50, and hematocrit < 45% as well as platelet count < 400 x 10(9)/L in patients aged > 50. Randomization will be stratified by participating center. The study is

  1. For and against a European quality control of training.

    PubMed

    Dimitrakakis, C; Michalas, S

    2001-01-01

    In a world of medicine that evolves more and more rapidly, sufficient quality of education in the arts and crafts of our discipline and control of this quality are essential for the progress and vitality of Ob/Gyn. There are variations in training within European countries but with the aim of harmonization in training programmes and the flexibility of quality control mechanisms we will meet our objective that is the high standards in the care of woman throughout Europe. PMID:11205701

  2. Clinical Research Methodology 3: Randomized Controlled Trials.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  3. Random transitions and cell cycle control.

    PubMed

    Brooks, R F

    1981-01-01

    Differences between the cycle times of sister cells are exponentially distributed, which means that these differences can be explained entirely by the existence of a single critical step in the cell cycle which occurs at random. Cycle times as a whole are not exponentially distributed, indicating an additional source of variation in the cell cycle. It follows that this additional variation must affect sister cells identically; ie, sister cell cycle times are correlated. This correlation and the overall distribution of cycle times can be predicted quantitatively by a model that was developed initially in order to explain certain problematic features of the response of quiescent cells to mitogenic stimulation - in particular, the significance of the lag that almost invariably occurs between stimulation and the onset of DNA synthesis. This model proposes that each cell cycle depends not on one but two random transitions, one of which (at reasonably high growth rates) occurs in the mother cell, its effects being inherited equally by the two daughter cells. The fundamental timing element in the cell cycle is proposed to be a lengthy process, called L, which accounts for most of the lag on mitogenic stimulation and also for the minimum cycle time in growing cultures. One of the random transitions is concerned with the initiation of L, whereas the other becomes possible on completion of L. The latter transition has two consequences: the first is the initiation of a sequence of events which includes S, G2 and M; the second is the restoration of the state from which L may be initiated once more. As a result, L may begin (at random) at any stage of the conventional cycle, ie, S, G2, M, or G1. There are marked similarities between the hypothetical process L and the biogenesis of mitotic centres - the structures responsible for organising the spindle poles. PMID:7312875

  4. A sensitivity analysis for subverting randomization in controlled trials.

    PubMed

    Marcus, S M

    2001-02-28

    In some randomized controlled trials, subjects with a better prognosis may be diverted into the treatment group. This subverting of randomization results in an unobserved non-compliance with the originally intended treatment assignment. Consequently, the estimate of treatment effect from these trials may be biased. This paper clarifies the determinants of the magnitude of the bias and gives a sensitivity analysis that associates the amount that randomization is subverted and the resulting bias in treatment effect estimation. The methods are illustrated with a randomized controlled trial that evaluates the efficacy of a culturally sensitive AIDS education video.

  5. PREFACE: European Workshop on Advanced Control and Diagnosis

    NASA Astrophysics Data System (ADS)

    Schulte, Horst; Georg, Sören

    2014-12-01

    The European Workshop on Advanced Control and Diagnosis is an annual event that has been organised since 2003 by Control Engineering departments of several European universities in Germany, France, the UK, Poland, Italy, Hungary and Denmark. The overall planning of the workshops is conducted by the Intelligent Control and Diagnosis (ICD) steering committee. This year's ACD workshop took place at HTW Berlin (University of Applied Sciences) and was organised by the Control Engineering group of School of Engineering I of HTW Berlin. 38 papers were presented at ACD 2014, with contributions spanning a variety of fields in modern control science: Discrete control, nonlinear control, model predictive control, system identification, fault diagnosis and fault-tolerant control, control applications, applications of fuzzy logic, as well as modelling and simulation, the latter two forming a basis for all tasks in modern control. Three interesting and high-quality plenary lectures were delivered. The first plenary speaker was Wolfgang Weber from Pepperl+Fuchs, a German manufacturer of state-of-the-art industrial sensors and process interfaces. The second and third plenary speakers were two internationally high-ranked researchers in their respective fields, Prof. Didier Theilliol from Université de Lorraine and Prof. Carsten Scherer from Universität Stuttgart. Taken together, the three plenary lectures sought to contribute to closing the gap between theory and applications. On behalf of the whole ACD 2014 organising committee, we would like to thank all those who submitted papers and participated in the workshop. We hope it was a fruitful and memorable event for all. Together we are looking forward to the next ACD workshop in 2015 in Pilsen, Czech Republic. Horst Schulte (General Chair), Sören Georg (Programme Chair)

  6. Agricultural pollution control under Spanish and European environmental policies

    NASA Astrophysics Data System (ADS)

    Martínez, Yolanda; Albiac, José

    2004-10-01

    Nonpoint pollution from agriculture is an important environmental policy issue in Spain and the European Union. Agricultural pollution in Spain is being addressed by the National Irrigation Plan and by the European Water Framework Directive. This article contributes to the ongoing policy decision process by analyzing nonpoint pollution control and presenting results on the efficiency of abatement measures. Results question the reliance of the Water Framework Directive on water pricing as a pollution instrument for reaching good status for all waters because higher water prices close to full recovery cost advocated by the directive appear to be inefficient as an emission control instrument. Another important result is that abatement measures based on input taxes and standards on nitrogen appear to be more suitable than the National Irrigation Plan subsidies designed to promote irrigation investments. The results also contribute with further evidence to the discussion on the appropriate instrument base for pollution control, proving that nonpoint pollution control instruments cannot be assessed accurately without a correct understanding of the key underlying biophysical processes. Nonpoint pollution is characterized by nonlinearities, dynamics, and spatial dependency, and neglect of the dynamic aspects may lead to serious consequences for the design of measures. Finally, a quantitative assessment has been performed to explore discriminating measures based on crop pollution potential on vulnerable soils. No significant welfare gains are found from discriminating control, although results are contingent upon the level of damage, and discrimination could be justified in areas with valuable ecosystems and severe pollution damages.

  7. Ocean versus atmosphere control on western European wintertime temperature variability

    NASA Astrophysics Data System (ADS)

    Yamamoto, Ayako; Palter, Jaime B.; Lozier, M. Susan; Bourqui, Michel S.; Leadbetter, Susan J.

    2015-12-01

    Using a novel Lagrangian approach, we assess the relative roles of the atmosphere and ocean in setting interannual variability in western European wintertime temperatures. We compute sensible and latent heat fluxes along atmospheric particle trajectories backtracked in time from four western European cities, using a Lagrangian atmospheric dispersion model driven with meteorological reanalysis data. The material time rate of change in potential temperature and the surface turbulent fluxes computed along the trajectory show a high degree of correlation, revealing a dominant control of ocean-atmosphere heat and moisture exchange in setting heat flux variability for atmospheric particles en route to western Europe. We conduct six idealised simulations in which one or more aspects of the climate system is held constant at climatological values and these idealised simulations are compared with a control simulation, in which all components of the climate system vary realistically. The results from these idealised simulations suggest that knowledge of atmospheric pathways is essential for reconstructing the interannual variability in heat flux and western European wintertime temperature, and that variability in these trajectories alone is sufficient to explain at least half of the internannual flux variability. Our idealised simulations also expose an important role for sea surface temperature in setting decadal scale variability of air-sea heat fluxes along the Lagrangian pathways. These results are consistent with previous studies showing that air-sea heat flux variability is driven by the atmosphere on interannual time scales over much of the North Atlantic, whereas the SST plays a leading role on longer time scales. Of particular interest is that the atmospheric control holds for the integrated fluxes along 10-day back trajectories from western Europe on an interannual time scale, despite that many of these trajectories pass over the Gulf Stream and its North Atlantic

  8. [Acceptance of alternative disease control strategies in the European Union].

    PubMed

    Nigsch, Annette; Depner, Klaus

    2012-01-01

    The European Commission intends to change its animal disease control strategy following the slogan "Prevention is better than cure". Vaccination and diagnostics should play a major role in emergency situations. A policy paper regarding the use of vaccines has been discussed with all Member States and the main aspects were evaluated in a questionnaire. In principle, the majority of Member States are in favour of a future strategy in which vaccination is replacing culling. However, questions regarding the pathogen freedom and the trade of vaccinated animals and animal products from vaccinated animals still remain open.

  9. Adaptive pumping for spectral control of random lasers

    NASA Astrophysics Data System (ADS)

    Bachelard, Nicolas; Gigan, Sylvain; Noblin, Xavier; Sebbah, Patrick

    2014-06-01

    A laser is not necessarily a sophisticated device: pumping an amplifying medium randomly filled with scatterers makes a perfectly viable `random laser'. The absence of mirrors greatly simplifies laser design, but control over the emission wavelength and directionality is lost, seriously hindering prospects for this otherwise simple laser. Recently, we proposed an approach to tame random lasers, inspired by coherent light control in complex media. Here, we implement this method in an optofluidic random laser where modes are spatially extended and overlap, making individual mode selection impossible, a priori. We show experimentally that control over laser emission can be regained even in this extreme case. By actively shaping the optical pump within the random laser, single-mode operation at any selected wavelength is achieved with spectral selectivity down to 0.06 nm and more than 10 dB side-lobe rejection. This method paves the way towards versatile tunable and controlled random lasers as well as the taming of other laser sources.

  10. Taming random lasers through active spatial control of the pump.

    PubMed

    Bachelard, N; Andreasen, J; Gigan, S; Sebbah, P

    2012-07-20

    Active control of the spatial pump profile is proposed to exercise control over random laser emission. We demonstrate numerically the selection of any desired lasing mode from the emission spectrum. An iterative optimization method is employed, first in the regime of strong scattering where modes are spatially localized and can be easily selected using local pumping. Remarkably, this method works efficiently even in the weakly scattering regime, where strong spatial overlap of the modes precludes spatial selectivity. A complex optimized pump profile is found, which selects the desired lasing mode at the expense of others, thus demonstrating the potential of pump shaping for robust and controllable single mode operation of a random laser.

  11. Taming Random Lasers through Active Spatial Control of the Pump

    NASA Astrophysics Data System (ADS)

    Bachelard, N.; Andreasen, J.; Gigan, S.; Sebbah, P.

    2012-07-01

    Active control of the spatial pump profile is proposed to exercise control over random laser emission. We demonstrate numerically the selection of any desired lasing mode from the emission spectrum. An iterative optimization method is employed, first in the regime of strong scattering where modes are spatially localized and can be easily selected using local pumping. Remarkably, this method works efficiently even in the weakly scattering regime, where strong spatial overlap of the modes precludes spatial selectivity. A complex optimized pump profile is found, which selects the desired lasing mode at the expense of others, thus demonstrating the potential of pump shaping for robust and controllable single mode operation of a random laser.

  12. Multiple input/output random vibration control system

    NASA Technical Reports Server (NTRS)

    Unruh, James F.

    1988-01-01

    A multi-input/output random vibration control algorithm was developed based on system identification concepts derived from random vibration spectral analysis theory. The unique features of the algorithm are: (1) the number of input excitors and the number of output control responses need not be identical; (2) the system inverse response matrix is obtained directly from the input/output spectral matrix; and (3) the system inverse response matrix is updated every control loop cycle to accommodate system amplitude nonlinearities. A laboratory demonstration case of two imputs with three outputs is presented to demonstrate the system capabilities.

  13. The Use of Control in Non-Randomized Designs.

    ERIC Educational Resources Information Center

    Halperin, Si; Jorgensen, Randall

    The concept of control is fundamental to comparative research. In research designs where randomization of observational units is not possible, control has been exercised statistically from a single covariate by a process of residualization. The alternative, known as subclassification on the propensity score, was developed primarily for…

  14. Affectionate Writing Reduces Total Cholesterol: Two Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Floyd, Kory; Mikkelson, Alan C.; Hesse, Colin; Pauley, Perry M.

    2007-01-01

    In two 5-week trials, healthy college students were randomly assigned either to experimental or control groups. Participants in the experimental groups wrote about their affection for significant friends, relatives, and/or romantic partners for 20 minutes on three separate occasions; on the same schedule, those in the control groups wrote about…

  15. Simulation of random wind fluctuations. [space shuttle ascent control

    NASA Technical Reports Server (NTRS)

    Perlmutter, M.

    1974-01-01

    A technique was developed for the simulation of random wind fluctuations for use in computer studies of the space shuttle ascent control. The simulated wind fluctuations were generated using the techniques of control theory that have statistical characteristics similar to the characteristics obtained from wind data at Kennedy Space Center.

  16. Challenges of randomized controlled trial design in plastic surgery.

    PubMed

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  17. Randomized Controlled Trials for the Treatment of Hidradenitis Suppurativa.

    PubMed

    van Rappard, Dominique C; Mekkes, Jan R; Tzellos, Thrasivoulos

    2016-01-01

    Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. Several treatment modalities are available, but most of them lack high-quality evidence. A systematic search was performed to identify all randomized controlled trials for the treatment of HS in order to review and evaluate the evidence. Recommendations for future randomized controlled trials include using validated scores, inclusion of patient rated outcomes, and thorough report of side effects. Evidence for long-term treatment and benefit/risk ratio of available treatment modalities is needed in order to enhance evidence-based treatment in daily clinical practice. Combining surgery with antiinflammatory treatment warrants further investigation.

  18. Improving Balance in Subacute Stroke Patients: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Goljar, Nika; Burger, Helena; Rudolf, Marko; Stanonik, Irena

    2010-01-01

    The aim of the study was to compare the efficacy of balance training in a balance trainer, a newly developed mechanical device for training balance, with conventional balance training in subacute stroke patients. This was a randomized controlled study. Fifty participants met the inclusion criteria and 39 finished the study. The participants were…

  19. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  20. Pedometer Use in University Freshmen: A Randomized Controlled Pilot Study

    ERIC Educational Resources Information Center

    LeCheminant, James D.; Smith, John D.; Covington, N. Kay; Hardin-Renschen, Tracie; Heden, Tim

    2011-01-01

    Objectives: To describe activity patterns associated with a pedometer intervention in university freshmen and compare the intervention participants to controls for several health outcomes. Methods: Forty-six university freshmen were randomized to a group that wore a pedometer across the academic year with a goal of 10,000 steps/day or to a control…

  1. A Randomized Controlled Trial of Two Online Mathematics Curricula

    ERIC Educational Resources Information Center

    Wang, Haiwen; Woodworth, Katrina

    2011-01-01

    This study applies a randomized controlled trial to examine the effects of supplemental instruction using two online mathematics curricula--DreamBox and Reasoning Mind. It is an independent evaluation intended to generate unbiased results that will help inform the ongoing development of a charter school network's hybrid instructional model, which…

  2. A Systematic Review of Randomized Controlled Studies of Art Therapy

    ERIC Educational Resources Information Center

    Maujean, Annick; Pepping, Christopher A.; Kendall, Elizabeth

    2014-01-01

    This review article examines current knowledge about the efficacy of art therapy based on the findings of 8 randomized controlled trials (RCTs) conducted with adult populations from 2008-2013 that met a high standard of rigor. Of these studies, all but one reported beneficial effects of art therapy. Review findings suggest that art therapy may…

  3. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    PubMed Central

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  4. Saving and Empowering Young Lives in Europe (SEYLE): a randomized controlled trial

    PubMed Central

    2010-01-01

    Background There have been only a few reports illustrating the moderate effectiveness of suicide-preventive interventions in reducing suicidal behavior, and, in most of those studies, the target populations were primarily adults, whereas few focused on adolescents. Essentially, there have been no randomized controlled studies comparing the efficacy, cost-effectiveness and cultural adaptability of suicide-prevention strategies in schools. There is also a lack of information on whether suicide-preventive interventions can, in addition to preventing suicide, reduce risk behaviors and promote healthier ones as well as improve young people's mental health. The aim of the SEYLE project, which is funded by the European Union under the Seventh Framework Health Program, is to address these issues by collecting baseline and follow-up data on health and well-being among European adolescents and compiling an epidemiological database; testing, in a randomized controlled trial, three different suicide-preventive interventions; evaluating the outcome of each intervention in comparison with a control group from a multidisciplinary perspective; as well as recommending culturally adjusted models for promoting mental health and preventing suicidal behaviors. Methods and design The study comprises 11,000 adolescents emitted from randomized schools in 11 European countries: Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain, with Sweden serving as the scientific coordinating center. Each country performs three active interventions and one minimal intervention as a control group. The active interventions include gatekeeper training (QPR), awareness training on mental health promotion for adolescents, and screening for at-risk adolescents by health professionals. Structured questionnaires are utilized at baseline, 3- and 12-month follow-ups in order to assess changes. Discussion Although it has been reported that suicide

  5. Control with a random access protocol and packet dropouts

    NASA Astrophysics Data System (ADS)

    Wang, Liyuan; Guo, Ge

    2016-08-01

    This paper investigates networked control systems whose actuators communicate with the controller via a limited number of unreliable channels. The access to the channels is decided by a so-called group random access protocol, which is modelled as a binary Markov sequence. Data packet dropouts in the channels are modelled as independent Bernoulli processes. For such systems, a systematic characterisation for controller synthesis is established and stated in terms of the transition probabilities of the Markov protocol and the packet dropout probabilities. The results are illustrated via a numerical example.

  6. Verifying a multiprocessor cache controller using random case generation

    SciTech Connect

    Wood, D.A.; Gibson, G.A.; Katz, R.H. )

    1989-01-01

    The newest generation of cache controller chips provide coherency to support multiprocessor systems, i.e., the controllers coordinate access to the cache memories to guarantee a single global view of memory. The cache coherency protocols they implement complicate the controller design, making design verification difficult. In the design of the cache controller for SPUR, a shared memory multiprocessor designed and built at U.C. Berkeley, the authors developed a random tester to generate and verify the complex interactions between multiple processors in the the functional simulation. Replacing the CPU model, the tester generates memory references by randomly selecting from a script of actions and checks. The checks verify correct completion of their corresponding actions. The tester was easy to develop, and detected over half of the functional bugs uncovered during simulation. They used an assembly language version of the random tester to verify the prototype hardware. A multiprocessor system is operational; it runs the Sprite operating system and is being used for experiments in parallel programming.

  7. Perceptions of Massage Therapists Participating in a Randomized Controlled Trial

    PubMed Central

    Perlman, Adam; Dreusicke, Mark; Keever, Teresa; Ali, Ather

    2015-01-01

    Background Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider–patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. Methods Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. Results Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. Conclusions Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials. PMID:26388961

  8. Extrinsic stain removal with a toothpowder: A randomized controlled trial

    PubMed Central

    Khan, Muhammad Khalil; Bokhari, Syed Akhtar Hussain; Haleem, Abdul; Kareem, Abdul; Khan, Ayyaz Ali; Hosein, Tasleem; Khan, Muhammad Usama

    2014-01-01

    Objectives The efficacy of a commercially available toothpowder was compared with toothpaste in removing extrinsic dental stains. Methods In this single-blind, randomized controlled trial, 77 volunteers were included from a residential professional college. All study subjects (control toothpaste users and test toothpowder users) plaque control measures. All study subjects were instructed to rinse with 5 ml 0.12% chlorhexidine mouthwash for 1 minute, twice and one cup of double tea bag solution three times daily for three weeks. Subjects were randomized into test (n=36) and control (n=36) groups. Toothpaste (control) and toothpowder (test) was used for two weeks to see the effects on removing stains on the labial surfaces of 12 anterior teeth. For measuring dental extrinsic stains Lobene Stain Index (SI) was used. Results The amount of stain following the use of toothpaste and toothpowder was more controlled with the experimental toothpowder. For all sites combined, there was evidence that the experimental toothpowder was significantly superior to toothpaste in reducing stain area (p<.001), stain intensity (p<.001) and composite/product (area × intensity) (p<.001). Conclusion Stain removing efficacy of toothpowder was significantly higher as compared with toothpaste. A toothpowder may be expected to be of benefit in controlling and removing extrinsic dental staining. PMID:25505862

  9. Randomized Controlled Trials in Health Technology Assessment: Overkill or Overdue?

    PubMed Central

    Bentzen, Søren M.

    2012-01-01

    Evidence-based medicine has become a cornerstone in the development of radiation oncology and the randomized controlled phase III trial remains the gold standard for assessing differential benefits in clinical outcome between therapies. Health technologies aimed at improving treatment quality should primarily be tested using process measures or operational characteristics, the reason being that the sensitivity and specificity of clinical outcome is low for detecting quality improvements. The ongoing discussion of the relative merits of intensity modulated photon vs. proton radiotherapy is used to illustrate these concepts. Concerns over clinical and individual equipoise as well as the potential limitations of health economics considerations in this setting are also discussed. Working in a technology and science based medical discipline, radiation oncology researchers need to further develop methodology for critical assessment of health technologies as a complement to randomized controlled trials. PMID:18237799

  10. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia

    PubMed Central

    Joffe, Grigori; Stenberg, Jan-Henry

    2015-01-01

    Background: Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. Methods: To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. Results: There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors’ efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Conclusions: Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups—plausibly due to differences in the mechanisms of action. Antidepressants may not worsen

  11. Supported Employment for the Reintegration of Disability Pensioners with Mental Illnesses: A Randomized Controlled Trial

    PubMed Central

    Viering, Sandra; Jäger, Matthias; Bärtsch, Bettina; Nordt, Carlos; Rössler, Wulf; Warnke, Ingeborg; Kawohl, Wolfram

    2015-01-01

    Work is beneficial for the recovery from mental illness. Although the approach of individual placement and support (IPS) has been shown to be effective in Europe, it has not yet been widely implemented in European health care systems. The aim of this randomized controlled trial was to assess the effectiveness of IPS for disability pensioners with mental illnesses new on disability benefits in Switzerland. In the study at hand, 250 participants were randomly assigned to either the control or the intervention group. The participants in the intervention group received job coaching according to IPS during 2 years. The control group received no structured support. Both groups were interviewed at baseline and followed up every 6 months (baseline, 6, 12, 16, 18, 24 months) for 2 years. Primary outcome was to obtain a job in the competitive employment. IPS was more effective for the reintegration into the competitive employment market for disability pensioners than the control condition. Thirty-two percent of the participants of the intervention group and 12% of the control group obtained new jobs in the competitive employment. IPS is also effective for the reintegration into competitive employment of people with mental illness receiving disability pensions. PMID:26539425

  12. A randomized controlled trial to promote volunteering in older adults.

    PubMed

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention.

  13. Active control of tensegrity structures under random excitation

    NASA Astrophysics Data System (ADS)

    Ganesh Raja, M.; Narayanan, S.

    2007-06-01

    In this paper we consider vibration control of tensegrity structures under stationary and nonstationary random excitations. These excitations may be representative of many physical loading conditions, such as earthquake, wind, aerodynamic and acoustic excitations. The optimal control theory based on H2 and \\mathrm {H}_{\\infty } controller with full state and limited state feedback is used for the control. The response of the tensegrity structure is represented by the zero lag covariance matrix and the same is obtained by solving the matrix Lyapunov equation. The force generated by the electro-mechanical coupling of the piezoelectric actuator is used in the formulation. A tensegrity structure of class-1 comprising of two modules, with 24 pretension cables and six struts with piezoelectric actuators, is considered.

  14. Validation of Placebo in a Manual Therapy Randomized Controlled Trial

    PubMed Central

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

    2015-01-01

    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months. PMID:26145718

  15. Randomly Sampled-Data Control Systems. Ph.D. Thesis

    NASA Technical Reports Server (NTRS)

    Han, Kuoruey

    1990-01-01

    The purpose is to solve the Linear Quadratic Regulator (LQR) problem with random time sampling. Such a sampling scheme may arise from imperfect instrumentation as in the case of sampling jitter. It can also model the stochastic information exchange among decentralized controllers to name just a few. A practical suboptimal controller is proposed with the nice property of mean square stability. The proposed controller is suboptimal in the sense that the control structure is limited to be linear. Because of i. i. d. assumption, this does not seem unreasonable. Once the control structure is fixed, the stochastic discrete optimal control problem is transformed into an equivalent deterministic optimal control problem with dynamics described by the matrix difference equation. The N-horizon control problem is solved using the Lagrange's multiplier method. The infinite horizon control problem is formulated as a classical minimization problem. Assuming existence of solution to the minimization problem, the total system is shown to be mean square stable under certain observability conditions. Computer simulations are performed to illustrate these conditions.

  16. Large-scale climatic control on European precipitation

    NASA Astrophysics Data System (ADS)

    Lavers, David; Prudhomme, Christel; Hannah, David

    2010-05-01

    Precipitation variability has a significant impact on society. Sectors such as agriculture and water resources management are reliant on predictable and reliable precipitation supply with extreme variability having potentially adverse socio-economic impacts. Therefore, understanding the climate drivers of precipitation is of human relevance. This research examines the strength, location and seasonality of links between precipitation and large-scale Mean Sea Level Pressure (MSLP) fields across Europe. In particular, we aim to evaluate whether European precipitation is correlated with the same atmospheric circulation patterns or if there is a strong spatial and/or seasonal variation in the strength and location of centres of correlations. The work exploits time series of gridded ERA-40 MSLP on a 2.5˚×2.5˚ grid (0˚N-90˚N and 90˚W-90˚E) and gridded European precipitation from the Ensemble project on a 0.5°×0.5° grid (36.25˚N-74.25˚N and 10.25˚W-24.75˚E). Monthly Spearman rank correlation analysis was performed between MSLP and precipitation. During winter, a significant MSLP-precipitation correlation dipole pattern exists across Europe. Strong negative (positive) correlation located near the Icelandic Low and positive (negative) correlation near the Azores High pressure centres are found in northern (southern) Europe. These correlation dipoles resemble the structure of the North Atlantic Oscillation (NAO). The reversal in the correlation dipole patterns occurs at the latitude of central France, with regions to the north (British Isles, northern France, Scandinavia) having a positive relationship with the NAO, and regions to the south (Italy, Portugal, southern France, Spain) exhibiting a negative relationship with the NAO. In the lee of mountain ranges of eastern Britain and central Sweden, correlation with North Atlantic MSLP is reduced, reflecting a reduced influence of westerly flow on precipitation generation as the mountains act as a barrier to moist

  17. The Effectiveness of Propolis on Gingivitis: A Randomized Controlled Trial

    PubMed Central

    Paulino, Niraldo; Nör, Jacques E.; Moreira, Alexandre

    2014-01-01

    Abstract Background: A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Methods: Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days −14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). Results: The 38 persons who completed the study (age 13–22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Conclusions: Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period. PMID:25380344

  18. Cognitive behavioral therapy for orthodontic pain control: a randomized trial.

    PubMed

    Wang, J; Jian, F; Chen, J; Ye, N S; Huang, Y H; Wang, S; Huang, R H; Pei, J; Liu, P; Zhang, L; Zhao, Z H; Chen, Q M; Lai, W L; Lin, Y F

    2012-06-01

    The objective of this study was to evaluate the efficacy of cognitive behavioral therapy intervention for patients who experienced pain during orthodontic treatment. The baseline characteristics were assessed via questionnaires and oral examinations. Four hundred and fifty eligible individuals were recruited and randomized by computer-generated block randomization into three groups: cognitive behavioral therapy intervention (n = 150), ibuprofen intervention (n = 150), and no intervention (control; n = 150). Primary outcomes were the change from baseline in pain intensity measured with 100-mm Visual Analog Scale (VAS) scores at 1, 2, 3, 7, 14, and 30 days after initial archwire placement. Outcomes assessment was blinded and followed the intention-to-treat principle. One hundred forty-three (95.30%), 145 (96.70%), and 141 (94.00%) individuals in the cognitive behavioral therapy, the ibuprofen, and the control groups, respectively, completed the one-month follow-up evaluations. Those in the cognitive behavioral therapy group showed a greater decrease in mean VAS scores than did those in the control group over the previous five time-points (p < 0.001). Cognitive behavioral therapy was shown to be effective in pain control during the initial stage of orthodontic treatment. The study registration number was ChiCTR-TRC-00000556.

  19. Biomimetic propulsion under random heaving conditions, using active pitch control

    NASA Astrophysics Data System (ADS)

    Politis, Gerasimos; Politis, Konstantinos

    2014-05-01

    Marine mammals travel long distances by utilizing and transforming wave energy to thrust through proper control of their caudal fin. On the other hand, manmade ships traveling in a wavy sea store large amounts of wave energy in the form of kinetic energy for heaving, pitching, rolling and other ship motions. A natural way to extract this energy and transform it to useful propulsive thrust is by using a biomimetic wing. The aim of this paper is to show how an actively pitched biomimetic wing could achieve this goal when it performs a random heaving motion. More specifically, we consider a biomimetic wing traveling with a given translational velocity in an infinitely extended fluid and performing a random heaving motion with a given energy spectrum which corresponds to a given sea state. A formula is invented by which the instantaneous pitch angle of the wing is determined using the heaving data of the current and past time steps. Simulations are then performed for a biomimetic wing at different heave energy spectra, using an indirect Source-Doublet 3-D-BEM, together with a time stepping algorithm capable to track the random motion of the wing. A nonlinear pressure type Kutta condition is applied at the trailing edge of the wing. With a mollifier-based filtering technique, the 3-D unsteady rollup pattern created by the random motion of the wing is calculated without any simplifying assumptions regarding its geometry. Calculated unsteady forces, moments and useful power, show that the proposed active pitch control always results in thrust producing motions, with significant propulsive power production and considerable beneficial stabilizing action to ship motions. Calculation of the power required to set the pitch angle prove it to be a very small percentage of the useful power and thus making the practical application of the device very tractable.

  20. The Beta Agonist Lung Injury Trial Prevention. A Randomized Controlled Trial

    PubMed Central

    Gates, Simon; Park, Daniel; Gao, Fang; Knox, Chris; Holloway, Ben; McAuley, Daniel F.; Ryan, James; Marzouk, Joseph; Cooke, Matthew W.; Lamb, Sarah E.; Thickett, David R.

    2014-01-01

    Rationale: Experimental studies suggest that pretreatment with β-agonists might prevent acute lung injury (ALI). Objectives: To determine if in adult patients undergoing elective esophagectomy, perioperative treatment with inhaled β-agonists effects the development of early ALI. Methods: We conducted a randomized placebo-controlled trial in 12 UK centers (2008–2011). Adult patients undergoing elective esophagectomy were allocated to prerandomized, sequentially numbered treatment packs containing inhaled salmeterol (100 μg twice daily) or a matching placebo. Patients, clinicians, and researchers were masked to treatment allocation. The primary outcome was development of ALI within 72 hours of surgery. Secondary outcomes were ALI within 28 days, organ failure, adverse events, survival, and health-related quality of life. An exploratory substudy measured biomarkers of alveolar-capillary inflammation and injury. Measurements and Main Results: A total of 179 patients were randomized to salmeterol and 183 to placebo. Baseline characteristics were similar. Treatment with salmeterol did not prevent early lung injury (32 [19.2%] of 168 vs. 27 [16.0%] of 170; odds ratio [OR], 1.25; 95% confidence interval [CI], 0.71–2.22). There was no difference in organ failure, survival, or health-related quality of life. Adverse events were less frequent in the salmeterol group (55 vs. 70; OR, 0.63; 95% CI, 0.39–0.99), predominantly because of a lower number of pneumonia (7 vs. 17; OR, 0.39; 95% CI, 0.16–0.96). Salmeterol reduced some biomarkers of alveolar inflammation and epithelial injury. Conclusion: Perioperative treatment with inhaled salmeterol was well tolerated but did not prevent ALI. Clinical trial registered with International Standard Randomized Controlled Trial Register (ISRCTN47481946) and European Union database of randomized Controlled Trials (EudraCT 2007-004096-19). PMID:24392848

  1. Building Kindergartners’ Number Sense: A Randomized Controlled Study

    PubMed Central

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2015-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

  2. Coblation tonsillectomy: a double blind randomized controlled study.

    PubMed

    Timms, M S; Temple, R H

    2002-06-01

    Tonsillectomy has been performed by a number of techniques. This double blind randomized controlled study compares the technique of tissue coblation with bipolar dissection for the removal of tonsils in 10 adult patients with a history of chronic tonsillitis. A significant reduction in post-operative pain and more rapid healing of the tonsillar fossae were found in the side removed by tissue coblation. There were no episodes of primary or secondary haemorrhage on either side. This new technique for tonsil removal warrants further study.

  3. Randomized controlled trial design in rheumatoid arthritis: the past decade

    PubMed Central

    Strand, Vibeke; Sokolove, Jeremy

    2009-01-01

    Much progress has occurred over the past decade in rheumatoid arthritis trial design. Recognized challenges have led to the establishment of a clear regulatory pathway to demonstrate efficacy of a new therapeutic. The use of pure placebo beyond 12 to 16 weeks has been demonstrated to be unethical and thus background therapy and/or early rescue has become regular practice. Goals of remission and 'treating to targets' may prove more relevant to identify real-world use of new and existing therapeutics. Identification of rare adverse events associated with new therapies has resulted in intensive safety evaluation during randomized controlled trials and emphasis on postmarketing surveillance and use of registries. PMID:19232061

  4. Efficacy of Yoga for Vasomotor Symptoms: A Randomized Controlled Trial

    PubMed Central

    Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2013-01-01

    Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673

  5. Online psychoeducational support for infertile women: a randomized controlled trial

    PubMed Central

    Cousineau, Tara M.; Green, Traci C.; Corsini, Evelyn; Seibring, A; Showstack, Marianne T.; Applegarth, Linda; Davidson, Marie; Perloe, Mark

    2008-01-01

    BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress (P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices. PMID:18089552

  6. Interpretations of parental control by Asian immigrant and European American youth.

    PubMed

    Chao, Ruth K; Aque, Christine

    2009-06-01

    Although studies have reported ethnic and cultural differences in the effects of parenting on adolescent well-being, rarely have they included specific examinations of the cultural processes underlying these differences. This study examined adolescents' affective interpretations of parents' control (i.e., feelings of anger toward control) and how these interpretations may moderate the relationship between control and adolescents' behavioral adjustment. The study comprised 1,085 immigrant youth of Chinese, Korean, and Filipino descent, and also European American youth from high schools in the greater Los Angeles area. Differences were found between European American and Asian immigrant youth in the effects of both behavioral control and psychological control. Furthermore, among European Americans only, as adolescents' feelings of anger increased, the beneficial consequences of behavioral control decreased, whereas the negative effects of psychological control on behavior problems decreased. The results suggest that feeling anger toward parents' use of psychological control may serve a protective function for European American youth but not for Asian immigrant youth. In contrast, feeling angry about behavioral control seems to reduce the beneficial consequences of control among European Americans but not Asian immigrants.

  7. Randomized Controlled Trial of Calcitriol in Severe Sepsis

    PubMed Central

    Raed, Anas; Donnino, Michael W.; Ginde, Adit A.; Waikar, Sushrut S.

    2014-01-01

    Rationale: Vitamin D and its metabolites have potent immunomodulatory effects in vitro, including up-regulation of cathelicidin, a critical antimicrobial protein. Objectives: We investigated whether administration of 1,25-dihydroxyvitamin D (calcitriol) to critically ill patients with sepsis would have beneficial effects on markers of innate immunity, inflammation, and kidney injury. Methods: We performed a double-blind, randomized, placebo-controlled, physiologic study among 67 critically ill patients with severe sepsis or septic shock. Patients were randomized to receive a single dose of calcitriol (2 μg intravenously) versus placebo. The primary outcome was plasma cathelicidin protein levels assessed 24 hours after study drug administration. Secondary outcomes included leukocyte cathelicidin mRNA expression, plasma cytokine levels (IL-10, IL-6, tumor necrosis factor-α, IL-1β, and IL-2), and urinary kidney injury markers. Measurements and Main Results: Patients randomized to calcitriol (n = 36) versus placebo (n = 31) had similar plasma cathelicidin protein levels at 24 hours (P = 0.16). Calcitriol-treated patients had higher cathelicidin (P = 0.04) and IL-10 (P = 0.03) mRNA expression than placebo-treated patients 24 hours after study drug administration. Plasma cytokine levels (IL-10, IL-6, tumor necrosis factor-α, IL-1β, and IL-2) and urinary kidney injury markers were similar in calcitriol- versus placebo-treated patients (P > 0.05 for all comparisons). Calcitriol had no effect on clinical outcomes nor were any adverse effects observed. Conclusions: Calcitriol administration did not increase plasma cathelicidin protein levels in critically ill patients with sepsis and had mixed effects on other immunomodulatory markers. Additional phase II trials investigating the dose and timing of calcitriol as a therapeutic agent in specific sepsis phenotypes may be warranted. Clinical trial registered with www.clinicaltrials.gov (NCT 01689441). PMID:25029202

  8. Preconception maternal nutrition: a multi-site randomized controlled trial

    PubMed Central

    2014-01-01

    Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of

  9. Diabetes Prevention in Hispanics: Report From a Randomized Controlled Trial

    PubMed Central

    Carosso, Elizabeth; Mariscal, Norma; Islas, Ilda; Ibarra, Genoveva; Holte, Sarah; Copeland, Wade; Linde, Sandra; Thompson, Beti

    2014-01-01

    Introduction Hispanics are at increased risk of developing type 2 diabetes. Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation. Methods We recruited Hispanic men and women (N = 320) who were residents of the Lower Yakima Valley, Washington, aged 18 years or older with hemoglobin A1c (HbA1c) levels higher than 6% to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012. The trial compared participants in the intervention arm, who received an immediate educational curriculum (n = 166), to participants in the control arm, who received a delayed educational curriculum (n = 154). The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes, diabetes treatment, and healthy dietary and physical activity behaviors. Participants were randomly assigned to the intervention and control arms, and analysts were blinded as to participant arm. We evaluated intervention effects on HbA1c levels; frequency (times per week) of fruit and vegetable consumption; and frequency (times per week) of mild, moderate, and strenuous leisure-time physical activity. At baseline, 3 months, and 6 months after randomization, participants completed a questionnaire and provided a blood sample. Analysts were blinded to intervention arm. Results The immediate intervention group (−0.64% [standard error (SE) 0.10]) showed a significant improvement in HbA1c scores (–37.5%, P = .04) compared with the delayed intervention group (–0.44%, P = .14). No significant changes were seen for dietary end points or changes in physical activity. We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group. Conclusion This home-based intervention delivered by CHWs was associated with a clinically and statistically

  10. Nurse Navigators in Early Cancer Care: A Randomized, Controlled Trial

    PubMed Central

    Wagner, Edward H.; Ludman, Evette J.; Aiello Bowles, Erin J.; Penfold, Robert; Reid, Robert J.; Rutter, Carolyn M.; Chubak, Jessica; McCorkle, Ruth

    2014-01-01

    Purpose To determine whether a nurse navigator intervention improves quality of life and patient experience with care for people recently given a diagnosis of breast, colorectal, or lung cancer. Patients and Methods Adults with recently diagnosed primary breast, colorectal, or lung cancer (n = 251) received either enhanced usual care (n = 118) or nurse navigator support for 4 months (n = 133) in a two-group cluster randomized, controlled trial with primary care physicians as the units of randomization. Patient-reported measures included the Functional Assessment of Cancer Therapy–General (FACT-G) Quality of Life scale, three subscales of the Patient Assessment of Chronic Illness Care (PACIC), and selected subscales from a cancer adaptation of the Picker Institute's patient experience survey. Self-report measures were collected at baseline, 4 months, and 12 months. Automated administrative data were used to assess time to treatment and total health care costs. Results There were no significant differences between groups in FACT-G scores. Nurse navigator patients reported significantly higher scores on the PACIC and reported significantly fewer problems with care, especially psychosocial care, care coordination, and information, as measured by the Picker instrument. Cumulative costs after diagnosis did not differ significantly between groups, but lung cancer costs were $6,852 less among nurse navigator patients. Conclusion Compared with enhanced usual care, nurse navigator support for patients with cancer early in their course improves patient experience and reduces problems in care, but did not differentially affect quality of life. PMID:24276777

  11. Randomized controlled trials in environmental health research: ethical issues.

    PubMed

    Resnik, David B

    2008-01-01

    Randomized controlled trials (RCTs) are becoming increasingly common in environmental health research. Like all studies involving human subjects, environmental health RCTs raise many ethical challenges, ranging from obtaining informed consent to minimizing risks to protecting privacy and confidentiality. One of the most important issues raised by these studies is whether it is ethical to withhold effective environmental health interventions from research subjects in order to satisfy scientific objectives. Although environmental health investigators usually do not have professional obligations to provide medical care to research subjects, they have ethical obligations to avoid exploiting them. Withholding interventions from research subjects can be ethical, provided that it does not lead to exploitation of individuals or groups. To avoid exploiting individuals or groups, investigators should ensure that research subjects and study populations receive a fair share of the benefits of research.

  12. [Critical of the additive model of the randomized controlled trial].

    PubMed

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  13. Ameliorating children's reading-comprehension difficulties: a randomized controlled trial.

    PubMed

    Clarke, Paula J; Snowling, Margaret J; Truelove, Emma; Hulme, Charles

    2010-08-01

    Children with specific reading-comprehension difficulties can read accurately, but they have poor comprehension. In a randomized controlled trial, we examined the efficacy of three interventions designed to improve such children's reading comprehension: text-comprehension (TC) training, oral-language (OL) training, and TC and OL training combined (COM). Children were assessed preintervention, midintervention, postintervention, and at an 11-month follow-up. All intervention groups made significant improvements in reading comprehension relative to an untreated control group. Although these gains were maintained at follow-up in the TC and COM groups, the OL group made greater gains than the other groups did between the end of the intervention and follow-up. The OL and COM groups also demonstrated significant improvements in expressive vocabulary compared with the control group, and this was a mediator of the improved reading comprehension of the OL and COM groups. We conclude that specific reading-comprehension difficulties reflect (at least partly) underlying oral-language weaknesses that can be effectively ameliorated by suitable teaching.

  14. Regression of Fibroadenomas with Centchroman: a Randomized Controlled Trial.

    PubMed

    Tejwani, Prakash Laxmichand; Nerkar, Hrishikesh; Dhar, Anita; Kataria, Kamal; Hari, Smriti; Thulkar, Sanjay; Chumber, Sunil; Kumar, Sunesh; Srivastava, Anurag

    2015-12-01

    Fibroadenoma is a common cause of breast lump in young girls. Nearly 10-15 % of lesions regress spontaneously over the period of 6 to 60 months. The aim of study was to investigate the role of Centchroman in regression of fibroadenoma in comparison to natural observation and to study the association of hormonal receptors with degree of regression. The study was carried out at the outpatient clinic of Department of Surgery, All India Institute of Medical Sciences, New Delhi, from November 2004 to November 2007. Patients aged ≤30 years with fibroadenoma were included. Patients with fibroadenoma equal to or larger than 5 cm and with polycystic ovarian disease were excluded. Patients were randomized in two groups. Patients in active therapy arm were prescribed Centchroman 30 mg daily for 12 weeks, and another group was observed without any intervention (control group). Patients were followed at weeks 4, 8, 12, and 24 to assess response to therapy. Twenty-two (31.88 %) fibroadenomas in Centchroman arm disappeared completely as compared to four (7.69 %) in control arm over a period of 6 months. There was a decrease in the volume of fibroadenoma in ten (19.23 %) patients in control arm and 36 (52.17 %) patients in Centchroman arm. Centchroman therapy allowed 31 % fibroadenoma to regress completely with scanty menses or amenorrhea as the only side effect. PMID:26730050

  15. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial.

    PubMed

    Praga, M; Barrio, V; Juárez, G Fernández; Luño, J

    2007-05-01

    Membranous nephropathy is a common cause of nephrotic syndrome in adults. Although some patients with membranous nephropathy achieve a spontaneous remission, renal function continues to deteriorate in others. We conducted a prospective randomized trial evaluating monotherapy with tacrolimus to achieve complete or partial remission in patients with biopsy-proven membranous nephropathy. Twenty-five patients received tacrolimus (0.05 mg/kg/day) over 12 months with a 6-month taper, whereas 23 patients were in the control group. The probability of remission in the treatment group was 58, 82, and 94% after 6, 12, and 18 months but only 10, 24, and 35%, respectively in the control group. The decrease in proteinuria was significantly greater in the treatment group. Notably, six patients in the control group and only one in the treatment group reached the secondary end point of a 50% increase in their serum creatinine. No patient in the tacrolimus group showed a relapse during the taper period. Nephrotic syndrome reappeared in almost half of the patients who were in remission by the 18th month after tacrolimus withdrawal. We conclude that tacrolimus is a very useful therapeutic option for patients with membranous nephropathy and preserved renal function. The majority of patients experienced remission with a significant reduction in the risk for deteriorating renal function.

  16. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    PubMed

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; p<0.05) and -2.84 mmHg (CI, -5.33 to -0.33 mmHg; p<0.05), respectively, after the 8-week intervention. The corresponding net change in renin activity was -1.17 ng/mL/h for the nattokinase group compared with the control group (p<0.05). In conclusion, nattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  17. Electroacupuncture for Primary Insomnia: A Randomized Controlled Trial

    PubMed Central

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Shi-Ping; Yap, Tuan-Gee; Law, Andrew C.K.

    2009-01-01

    Study Objectives: To evaluate the short-term efficacy and safety of electroacupuncture for the treatment of primary insomnia. Design: Randomized, single-blind, placebo-controlled, parallel-group. Setting: A university-based sleep clinic. Participants: Community sample of 60 Chinese adult volunteers who report having insomnia 3 or more nights per week, whose symptoms meet the DSM-IV criteria for primary insomnia for at least 3 months, and who have an Insomnia Severity Index total score of at least 15. Participants were screened with polysomnography and the Structured Clinical Interview for the DSM-IV prior to randomization. Intervention: Electroacupuncture at Yintang (EX-HN3), Baihui (GV20), bilateral ear Shenmen, Sishencong (EX-HN1), and Anmian (EX) 3 times per week for 3 weeks or placebo acupuncture using Streitberger needles at the same points. Measurements and Results: Self-reported questionnaires, 1-week sleep diaries, and 3-day actigraphy were collected at baseline and 1 week after treatment. The Insomnia Severity Index was used as the primary outcome measure. Both groups showed significant improvement compared with the pretreatment baseline. One-way analysis of covariance adjusted for baseline scores showed that there were significantly greater improvements in sleep efficiency by sleep diary and actigraphy in the electroacupuncture group. However, no significant between-group differences were observed in the Insomnia Severity Index and other outcome measures. The proportions of subjects having less than 30 minutes of wake after sleep onset and a sleep efficiency of at least 85% at the posttreatment visit were significantly higher in the electroacupuncture group. All adverse events were mild in severity. Conclusion: We found a slight advantage of electroacupuncture over placebo acupuncture in the short-term treatment of primary insomnia. Because of some limitations of the current study, further studies are necessary to verify the effectiveness of acupuncture

  18. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    PubMed Central

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y

  19. Emphasized warning reduces salt intake: a randomized controlled trial.

    PubMed

    Pinjuh Markota, Nina; Rumboldt, Mirjana; Rumboldt, Zvonko

    2015-03-01

    Excessive salt intake is a major cardiovascular risk factor. At variance to the developed countries, the main source of sodium in transitional and developing countries is salt added while cooking and/or at the table. The objective of this trial was to examine the impact of warning labels placed on home salt containers on daily salt intake.A sample of treated hypertensives (n = 150) was randomized in two subgroups, one receiving just a leaflet about the harmful effects of excessive salt intake (control; n = 74), and the other one receiving in addition warning stickers for household salt containers (intervention; n = 76). Arterial blood pressure (BP) and 24-hour urinary sodium excretion (Na24) were measured in all the subjects at the start of the trial, and 1 month and 2 months later. The average starting Na24 was 207 ± 71 mmol in the control group and 211 ± 85 mmol in the intervention group (P = .745). One month and 2 months later, a significant decrease was observed in the intervention group (to 183 ± 63 mmol and 176 ± 55 mmol; P < .0001), as opposed to the control group (203 ± 60 mmol and 200 ± 58 mmol; P = .1466). Initial BP was 143.7/84.1 mm Hg in the control, and 142.9/84.7 mm Hg in the intervention group (P = .667). One month and 2 months later, a significant drop in BP, by 5.3/2.9 mm Hg, was observed in the intervention group as opposed to the control group (0.4/0.9 mm Hg). Decrease in Na24 positively correlated to BP lowering (r(2) = 0.5989; P < .0001). A significant reduction in 24Na and BP is achieved with warning labels on harmful effects of excessive salt intake. Decreasing daily salt input by 35 mmol may result in an extra BP lowering by some 5-6/2-3 mm Hg.

  20. Effect of nitrous oxide on cisatracurium infusion demands: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Recent studies have questioned our previous understanding on the effect of nitrous oxide on muscle relaxants, since nitrous oxide has been shown to potentiate the action of bolus doses of mivacurium, rocuronium and vecuronium. This study was aimed to investigate the possible effect of nitrous oxide on the infusion requirements of cisatracurium. Methods 70 ASA physical status I-III patients aged 18-75 years were enrolled in this randomized trial. The patients were undergoing elective surgery requiring general anesthesia with a duration of at least 90 minutes. Patients were randomized to receive propofol and remifentanil by target controlled infusion in combination with either a mixture of oxygen and nitrous oxide (Nitrous oxide/TIVA group) or oxygen in air (Air/TIVA group). A 0.1 mg/kg initial bolus of cisatracurium was administered before tracheal intubation, followed by a closed-loop computer controlled infusion of cisatracurium to produce and maintain a 90% neuromuscular block. Cumulative dose requirements of cisatracurium during the 90-min study period after bolus administration were measured and the asymptotic steady state rate of infusion to produce a constant 90% block was determined by applying nonlinear curve fitting to the data on the cumulative dose requirement during the study period. Results Controller performance, i.e. the ability of the controller to maintain neuromuscular block constant at the setpoint and patient characteristics were similar in both groups. The administration of nitrous oxide did not affect cisatracurium infusion requirements. The mean steady-state rates of infusion were 0.072 +/- 0.018 and 0.066 +/- 0.017 mg * kg-1 * h-1 in Air/TIVA and Nitrous oxide/TIVA groups, respectively. Conclusions Nitrous oxide does not affect the infusion requirements of cisatracurium. Trial registration ClinicalTrials.gov NCT01152905; European Clinical Trials Database at http://eudract.emea.eu.int/2006-006037-41. PMID:20718983

  1. Teaching Children to Cross Streets Safely: A Randomized Controlled Trial

    PubMed Central

    Schwebel, David C.; McClure, Leslie A.; Severson, Joan

    2014-01-01

    Objective Child pedestrian injury is a global public health challenge. This randomized controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and websites, plus no-training control, to improve children’s street-crossing ability. Methods Pedestrian safety was evaluated among 231 seven- and eight-year-olds using both streetside (field) and laboratory-based (virtual environment) trials prior to intervention group assignment, immediately post-training, and six months post-training. All training groups received six 30-minute sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior post-intervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly post-training than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in post-intervention VR trials. Children showed minimal change in attention to traffic post-training. Children trained with videos/websites showed minimal learning. Conclusion Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds’ street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly

  2. Asthma self-management model: randomized controlled trial.

    PubMed

    Olivera, Carolina M X; Vianna, Elcio Oliveira; Bonizio, Roni C; de Menezes, Marcelo B; Ferraz, Erica; Cetlin, Andrea A; Valdevite, Laura M; Almeida, Gustavo A; Araujo, Ana S; Simoneti, Christian S; de Freitas, Amanda; Lizzi, Elisangela A; Borges, Marcos C; de Freitas, Osvaldo

    2016-10-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by a pharmacist (intervention group) and 59 patients in the control group. Data collection was performed before and after this 4-month intervention and included an evaluation of asthma knowledge, lifestyle, inhaler techniques, adhesion to treatment, pulmonary function and quality of life. An economic viability analysis was also performed. The intervention group obtained an increase in asthma knowledge scores of 58.3-79.5% (P < 0.001). In this group, there was also an increase in the number of individuals who practiced physical exercise (36-43%), in the number of correct replies regarding the use of inhalers, in the percentage of adherent patients, and in quality of life scores for all domains. We concluded that this asthma self-management model was effective in improving the quality of life of asthma patients. PMID:27473571

  3. Acupuncture for posttraumatic stress disorder: a randomized controlled pilot trial.

    PubMed

    Hollifield, Michael; Sinclair-Lian, Nityamo; Warner, Teddy D; Hammerschlag, Richard

    2007-06-01

    The purpose of the study was to evaluate the potential efficacy and acceptability of accupuncture for posttraumatic stress disorder (PTSD). People diagnosed with PTSD were randomized to either an empirically developed accupuncture treatment (ACU), a group cognitive-behavioral therapy (CBT), or a wait-list control (WLC). The primary outcome measure was self-reported PTSD symptoms at baseline, end treatment, and 3-month follow-up. Repeated measures MANOVA was used to detect predicted Group X Time effects in both intent-to-treat (ITT) and treatment completion models. Compared with the WLC condition in the ITT model, accupuncture provided large treatment effects for PTSD (F [1, 46] = 12.60; p < 0.01; Cohen's d = 1.29), similar in magnitude to group CBT (F [1, 47] = 12.45; p < 0.01; d = 1.42) (ACU vs. CBT, d = 0.29). Symptom reductions at end treatment were maintained at 3-month follow-up for both interventions. Accupuncture may be an efficacious and acceptable nonexposure treatment option for PTSD. Larger trials with additional controls and methods are warranted to replicate and extend these findings. PMID:17568299

  4. Outpatient versus inpatient opioid detoxification: a randomized controlled trial.

    PubMed

    Day, Ed; Strang, John

    2011-01-01

    Opioid detoxification is not an effective stand-alone treatment for heroin dependence but is nevertheless an essential step in the path to recovery. There has been relatively little previous controlled research on the impact of treatment setting on the likelihood of successful completion of detoxification. In this study, 68 opioid-dependent patients receiving community treatment (predominantly with methadone) and requesting detoxification were randomly assigned to an inpatient versus outpatient setting. Both groups received the same medication (lofexidine), and the primary outcome measure was being opioid-free at detoxification completion. More inpatients (n = 18, 51.4%) than outpatients (n = 12, 36.4%) completed detoxification, but this difference was not statistically significant (χ(2) = 1.56, p = .21). However, the outpatient group received a significantly longer period of medication, and when the length of detoxification was controlled for, the results favored the inpatient setting (Exp(B) = 13.9, 95% confidence interval = 2.6-75.5, p = .002). Only 11 (16%) participants were opioid-free at the 1-month follow-up and 8 at the 6-month follow-up, with no between-group difference. Inpatient and outpatient opioid detoxification settings were not significantly different in completion or follow-up abstinence rates, but aspects of the study design may have favored the outpatient setting. Future studies should test patient characteristics that predict better outcomes in each setting.

  5. Exercise during pregnancy attenuates prenatal depression: a randomized controlled trial.

    PubMed

    Perales, M; Refoyo, I; Coteron, J; Bacchi, M; Barakat, R

    2015-03-01

    Recent studies have estimated the prevalence of depression during pregnancy to be between 10% and 30%, which is higher than that in the postpartum period. Pharmacological treatment during pregnancy is difficult because of the possible side effects of antidepressants on the mother and the fetus. The aim of this study was to examine whether a supervised exercise program (EP) reduces depressive symptoms in pregnant women. A randomized controlled trial was designed. One hundred eighty four healthy pregnant women from Fuenlabrada Hospital were included (31.37 ± 3.62 years). Women from the exercise group (EG) participated in a supervised EP consisting of three, 55- to 60-min sessions per week throughout pregnancy. The main outcome measure was the patients' depression level assessed by means of the Center for Epidemiologic Studies Depression Scale (CES-D). A total of 167 pregnant women were analyzed; 90 were allocated to the EG and 77 to the control group (CG). Significant differences were found between groups at the end of the study in CES-D scores (EG: 7.67 ± 6.30 vs. CG: 11.34 ± 9.74, p = .005) and in percentages of pregnant women depressed (EG: n = 11/12.2% vs. CG: n = 19/24.7%, p = .04). Our results show that supervised physical exercise during pregnancy reduces the level of depression and its incidence in pregnant women.

  6. HealthLinks randomized controlled trial: Design and baseline results.

    PubMed

    Hannon, Peggy A; Hammerback, Kristen; Allen, Claire L; Parrish, Amanda T; Chan, K Gary; Kohn, Marlana J; Teague, Sara; Beresford, Shirley A A; Helfrich, Christian D; Harris, Jeffrey R

    2016-05-01

    Small employers, especially those in low-wage industries, frequently lack the capacity and resources to implement evidence-based health promotion interventions without support and assistance. The purpose of this paper is to (a) describe the intervention design and study protocol of the HealthLinks Trial and (b) report baseline findings. This study is a three-arm randomized controlled trial testing the impact of the HealthLinks intervention on worksites' adoption and implementation of evidence-based interventions. Group 1 will receive HealthLinks, Group 2 will receive HealthLinks plus wellness committees, and Group 3 will be a delayed control group. Seventy-eight employers are participating in the study; and 3302 employees across the worksites participated in the baseline data collection. Employers and employees will participate in follow-up surveys at one and two years after baseline to measure implementation (one year) and maintenance (two years) of HealthLinks interventions. Study outcomes will determine whether HealthLinks is an effective approach to increasing evidence-based health promotion in small, low-wage worksites and whether wellness committees are a capacity-building tool that increases HealthLinks' effectiveness. PMID:26946121

  7. Laparoscopically assisted ventriculoperitoneal shunt placement: a prospective randomized controlled trial.

    PubMed

    Schucht, Philippe; Banz, Vanessa; Trochsler, Markus; Iff, Samuel; Krähenbühl, Anna Katharina; Reinert, Michael; Beck, Jürgen; Raabe, Andreas; Candinas, Daniel; Kuhlen, Dominique; Mariani, Luigi

    2015-05-01

    OBJECT In ventriculoperitoneal (VP) shunt surgery, laparoscopic assistance can be used for placement of the peritoneal catheter. Until now, the efficacy of laparoscopic shunt placement has been investigated only in retrospective and nonrandomized prospective studies, which have reported decreased distal shunt dysfunction rates in patients undergoing laparascopic placement compared with mini-laparotomy cohorts. In this randomized controlled trial the authors compared rates of shunt failure in patients who underwent laparoscopic surgery for peritoneal catheter placement with rates in patients who underwent traditional mini-laparotomy. METHODS One hundred twenty patients scheduled for VP shunt surgery were randomized to laparoscopic surgery or mini-laparotomy for insertion of the peritoneal catheter. The primary endpoint was the rate of overall shunt complication or failure within the first 12 months after surgery. Secondary endpoints were distal shunt failure, overall complication/ failure, duration of surgery and hospitalization, and morbidity. RESULTS The overall shunt complication/failure rate was 15% (9 of 60 cases) in the laparoscopic group and 18.3% (11 of 60 cases) in the mini-laparotomy group (p = 0.404). Patients in the laparoscopic group had no distal shunt failures; in contrast, 5 (8%) of 60 patients in the mini-laparotomy group experienced distal shunt failure (p = 0.029). Intraoperative complications occurred in 2 patients (both in the laparoscopic group), and abdominal pain led to catheter removal in 1 patient per group. Infections occurred in 1 patient in the laparoscopic group and 3 in the mini-laparotomy group. The mean durations of surgery and hospitalization were similar in the 2 groups. CONCLUSIONS While overall shunt failure rates were similar in the 2 groups, the use of laparoscopic shunt placement significantly reduced the rate of distal shunt failure compared with mini-laparotomy.

  8. Facing depression with botulinum toxin: a randomized controlled trial.

    PubMed

    Wollmer, M Axel; de Boer, Claas; Kalak, Nadeem; Beck, Johannes; Götz, Thomas; Schmidt, Tina; Hodzic, Muris; Bayer, Ursula; Kollmann, Thilo; Kollewe, Katja; Sönmez, Daniela; Duntsch, Katja; Haug, Martin D; Schedlowski, Manfred; Hatzinger, Martin; Dressler, Dirk; Brand, Serge; Holsboer-Trachsler, Edith; Kruger, Tillmann H C

    2012-05-01

    Positive effects on mood have been observed in subjects who underwent treatment of glabellar frown lines with botulinum toxin and, in an open case series, depression remitted or improved after such treatment. Using a randomized double-blind placebo-controlled trial design we assessed botulinum toxin injection to the glabellar region as an adjunctive treatment of major depression. Thirty patients were randomly assigned to a verum (onabotulinumtoxinA, n = 15) or placebo (saline, n = 15) group. The primary end point was change in the 17-item version of the Hamilton Depression Rating Scale six weeks after treatment compared to baseline. The verum and the placebo groups did not differ significantly in any of the collected baseline characteristics. Throughout the sixteen-week follow-up period there was a significant improvement in depressive symptoms in the verum group compared to the placebo group as measured by the Hamilton Depression Rating Scale (F((6,168)) = 5.76, p < 0.001, η(2) = 0.17). Six weeks after a single treatment scores of onabotulinumtoxinA recipients were reduced on average by 47.1% and by 9.2% in placebo-treated participants (F((1,28)) = 12.30, p = 0.002, η(2) = 0.31, d = 1.28). The effect size was even larger at the end of the study (d = 1.80). Treatment-dependent clinical improvement was also reflected in the Beck Depression Inventory, and in the Clinical Global Impressions Scale. This study shows that a single treatment of the glabellar region with botulinum toxin may shortly accomplish a strong and sustained alleviation of depression in patients, who did not improve sufficiently on previous medication. It supports the concept, that the facial musculature not only expresses, but also regulates mood states. PMID:22364892

  9. Rural providers' access to online resources: a randomized controlled trial

    PubMed Central

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  10. Factors controlling air quality in different European subway systems.

    PubMed

    Martins, Vânia; Moreno, Teresa; Mendes, Luís; Eleftheriadis, Konstantinos; Diapouli, Evangelia; Alves, Célia A; Duarte, Márcio; de Miguel, Eladio; Capdevila, Marta; Querol, Xavier; Minguillón, María Cruz

    2016-04-01

    Sampling campaigns using the same equipment and methodology were conducted to assess and compare the air quality at three South European subway systems (Barcelona, Athens and Oporto), focusing on concentrations and chemical composition of PM2.5 on subway platforms, as well as PM2.5 concentrations inside trains. Experimental results showed that the mean PM2.5 concentrations widely varied among the European subway systems, and even among different platforms within the same underground system, which might be associated to distinct station and tunnel designs and ventilation systems. In all cases PM2.5 concentrations on the platforms were higher than those in the urban ambient air, evidencing that there is generation of PM2.5 associated with the subway systems operation. Subway PM2.5 consisted of elemental iron, total carbon, crustal matter, secondary inorganic compounds, insoluble sulphate, halite and trace elements. Of all metals, Fe was the most abundant, accounting for 29-43% of the total PM2.5 mass (41-61% if Fe2O3 is considered), indicating the existence of an Fe source in the subway system, which could have its origin in mechanical friction and wear processes between rails, wheels and brakes. The trace elements with the highest enrichment in the subway PM2.5 were Ba, Cu, Mn, Zn, Cr, Sb, Sr, Ni, Sn, Co, Zr and Mo. Similar PM2.5 diurnal trends were observed on platforms from different subway systems, with higher concentrations during subway operating hours than during the transport service interruption, and lower levels on weekends than on weekdays. PM2.5 concentrations depended largely on the operation and frequency of the trains and the ventilation system, and were lower inside the trains, when air conditioning system was operating properly, than on the platforms. However, the PM2.5 concentrations increased considerably when the train windows were open. The PM2.5 levels inside the trains decreased with the trains passage in aboveground sections.

  11. Factors controlling air quality in different European subway systems.

    PubMed

    Martins, Vânia; Moreno, Teresa; Mendes, Luís; Eleftheriadis, Konstantinos; Diapouli, Evangelia; Alves, Célia A; Duarte, Márcio; de Miguel, Eladio; Capdevila, Marta; Querol, Xavier; Minguillón, María Cruz

    2016-04-01

    Sampling campaigns using the same equipment and methodology were conducted to assess and compare the air quality at three South European subway systems (Barcelona, Athens and Oporto), focusing on concentrations and chemical composition of PM2.5 on subway platforms, as well as PM2.5 concentrations inside trains. Experimental results showed that the mean PM2.5 concentrations widely varied among the European subway systems, and even among different platforms within the same underground system, which might be associated to distinct station and tunnel designs and ventilation systems. In all cases PM2.5 concentrations on the platforms were higher than those in the urban ambient air, evidencing that there is generation of PM2.5 associated with the subway systems operation. Subway PM2.5 consisted of elemental iron, total carbon, crustal matter, secondary inorganic compounds, insoluble sulphate, halite and trace elements. Of all metals, Fe was the most abundant, accounting for 29-43% of the total PM2.5 mass (41-61% if Fe2O3 is considered), indicating the existence of an Fe source in the subway system, which could have its origin in mechanical friction and wear processes between rails, wheels and brakes. The trace elements with the highest enrichment in the subway PM2.5 were Ba, Cu, Mn, Zn, Cr, Sb, Sr, Ni, Sn, Co, Zr and Mo. Similar PM2.5 diurnal trends were observed on platforms from different subway systems, with higher concentrations during subway operating hours than during the transport service interruption, and lower levels on weekends than on weekdays. PM2.5 concentrations depended largely on the operation and frequency of the trains and the ventilation system, and were lower inside the trains, when air conditioning system was operating properly, than on the platforms. However, the PM2.5 concentrations increased considerably when the train windows were open. The PM2.5 levels inside the trains decreased with the trains passage in aboveground sections. PMID:26717078

  12. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    ERIC Educational Resources Information Center

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  13. 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.

  14. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial

    PubMed Central

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research. PMID:27703964

  15. Control Capacity and A Random Sampling Method in Exploring Controllability of Complex Networks

    PubMed Central

    Jia, Tao; Barabási, Albert-László

    2013-01-01

    Controlling complex systems is a fundamental challenge of network science. Recent advances indicate that control over the system can be achieved through a minimum driver node set (MDS). The existence of multiple MDS's suggests that nodes do not participate in control equally, prompting us to quantify their participations. Here we introduce control capacity quantifying the likelihood that a node is a driver node. To efficiently measure this quantity, we develop a random sampling algorithm. This algorithm not only provides a statistical estimate of the control capacity, but also bridges the gap between multiple microscopic control configurations and macroscopic properties of the network under control. We demonstrate that the possibility of being a driver node decreases with a node's in-degree and is independent of its out-degree. Given the inherent multiplicity of MDS's, our findings offer tools to explore control in various complex systems. PMID:23912679

  16. Coblation versus traditional tonsillectomy: A double blind randomized controlled trial

    PubMed Central

    Omrani, Mohammadreza; Barati, Behrouz; Omidifar, Navid; Okhovvat, Ahmad Reza; Hashemi, Seyed Amirhossein Ghazizadeh

    2012-01-01

    BACKGROUND: Coblation tonsillectomy is a new surgical technique and demands further research to be proven as a suitable and standard method of tonsillectomy. This study compares coblation and traditional tonsillectomy techniques in view of their advantages and complications. METHODS: In a prospective double-blind randomized controlled trial information on operation time, intraoperative blood loss, postoperative pain, time needed to regain the normal diet and activity and postoperative hemorrhage were gathered and compared between two groups containing 47 patients in each group. RESULTS: We found statistically significant differences in operation time (p < 0.05), intraoperative blood loss (p < 0.05), postoperative pain (p < 0.001), time needed to find back the normal diet (p < 0.001) and normal activity (p < 0.001). However, post operation hemorrhage (p > 0.5) was not significantly different between two groups. CONCLUSIONS: This study revealed a significantly less intraoperative or postoperative complications and morbidity in coblation tonsillectomy in comparison with traditional method. Coblation was associated with less pain and quick return to normal diet and daily activity. These findings addressed coblation tonsillectomy as an advanced method. PMID:23248656

  17. Evaluating cognitive effort in a randomized controlled trial.

    PubMed

    Turner, Travis H; Renfroe, Jenna B; Morella, Kristen; Marriott, Bernadette P

    2016-09-01

    Many randomized controlled trials (RCTs) of neuropsychiatric conditions involve cognitive outcome measures; however, validity of cognitive data relies on adequate effort during testing, and such screening is seldom performed. Given well-established rates of 10 to 30% poor effort in clinical settings, this is not a trivial concern. This preliminary study evaluated effort during cognitive testing in an RCT of omega-3 supplementation to reduce suicidality in a high-risk psychiatric population. An interim analysis of sustained attentions measures from the Connors Performance Test (CPT-2) at baseline for the first 60 participants was conducted. Previously validated cut points to detect insufficient effort on the CPT-2 were applied. At baseline, 12% (7) were identified as giving poor effort. Follow-up analyses indicated less psychiatric distress and suicidality among those who gave poor effort. Results suggest comparable likelihood of a poor effort on cognitive testing in clinical and RCT participation. Reduced psychiatric distress in the poor effort group raises concern regarding interpretation of other measures. The importance of screening cognitive data for effort in RCTs is highlighted. Future studies will examine effort at follow-up visits, and explore relationships to attrition, adherence, and response to treatment. Copyright © 2016 John Wiley & Sons, Ltd.

  18. Randomized controlled trials – a matter of design

    PubMed Central

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial. PMID:27354804

  19. Randomized controlled trials to assess therapies for multiple sclerosis.

    PubMed

    Wingerchuk, Dean M; Noseworthy, John H

    2002-04-23

    MS poses formidable challenges to clinical investigators. Obstacles to the study of MS therapies include disease chronicity, an unpredictable clinical course, radiologic and pathologic heterogeneity, and limited understanding of the underlying pathophysiology. Randomized controlled trials (RCTs) provide a means to assess therapeutic efficacy while reducing the risks of study bias and confounding factors that influence interpretation of results. RCTs have demonstrated that type 1 interferons and glatiramer acetate alter the short-term natural history of MS and have served as the basis of approval for the marketing of these treatments. Improvements and optimization of trial methodology may hasten the discovery of effective therapies and facilitate better comparisons of the results of individual drug trials. The most urgent need is for improved surrogate end points for clinical outcome with predictive validity for long-term disability. Even if RCT methodology is optimal, however, several limitations inherent to MS trials threaten to impede further progress, including obstacles to long-term studies (e.g., costs), patient withdrawal, and escalating sample size requirements to detect partial therapeutic benefit. There is a crucial need to develop alternative investigative methods, possibly through enhanced collaboration across centers and with industry, and by exploring innovative techniques to use existing RCT and natural history databases to greater advantage.

  20. Prenatal emotion management improves obstetric outcomes: a randomized control study

    PubMed Central

    Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

    2015-01-01

    Introduction: Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. Methods: All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. Results: The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P < 0.01), and a lower EPDS score 42 days postpartum (P < 0.05). The rate of cesarean section in the EM group was lower than the UC group (P < 0.01), and the cesarean section rate without a medical indication was lower (P < 0.01). The duration of the second stage of labor in the EM group was shorter than the UC group (P < 0.01). Conclusions: Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China. PMID:26309641

  1. Carnosine Treatment for Gulf War Illness: A Randomized Controlled Trial

    PubMed Central

    Baraniuk, James N.; El-Amin, Suliman; Corey, Rebecca; Rayhan, Rakib U.; Timbol, Christian R.

    2013-01-01

    About 25% of 1990-1991 Persian Gulf War veterans experience disabling fatigue, widespread pain, and cognitive dysfunction termed Gulf War illness (GWI) or Chronic Multisymptom Illness (CMI). A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species (ROS) and central nervous system injury. The endogenous antioxidant L-carnosine (β-alanyl-L-histidine) is a potential treatment since it is a free radical scavenger in nervous tissue. To determine if nutritional supplementation with L-carnosine would significantly improve pain, cognition and fatigue in GWI, a randomized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed. L-carnosine was given as 500, 1000, and 1500 mg increasing at 4 week intervals. Outcomes included subjective fatigue, pain and psychosocial questionnaires, and instantaneous fatigue and activity levels recorded by ActiWatch Score devices. Cognitive function was evaluated by WAIS-R digit symbol substitution test. Carnosine had 2 potentially beneficial effects: WAIS-R scores increased significantly, and there was a decrease in diarrhea associated with irritable bowel syndrome. No other significant incremental changes were found. Therefore, 12 weeks of carnosine (1500 mg) may have beneficial cognitive effects in GWI. Fatigue, pain, hyperalgesia, activity and other outcomes were resistant to treatment. PMID:23618477

  2. Acupuncture for Functional Dyspepsia: A Single Blinded, Randomized, Controlled Trial

    PubMed Central

    Jin, Yulian; Zhao, Qing; Zhou, Kehua; Jing, Xianghong; Yu, Xiaochun; Fang, Jiliang; Liu, Zhishun; Zhu, Bing

    2015-01-01

    In order to investigate the therapeutic potential of acupuncture on patients with functional dyspepsia (FD), patients were randomized to receive acupuncture at classic acupoints with manipulations (treatment group) versus acupuncture at nonacupoints without manipulation (control group) once every other day, three times a week, for one month and were followed up for three months. The primary outcomes included dyspeptic symptoms, quality of life, and mental status. The secondary outcomes included the fasting serum gastrin concentration, and frequency and propagation velocity of gastric slow waves. Sixty patients with FD were included, among whom, four dropped out. After one month's treatment, patients with FD showed significant improvements in primary (in both groups) and secondary (in the eight patients of the treatment group) outcomes as compared with baseline (P = 0.0078 to <0.0001); treatment group has better outcomes in all primary outcome measures (P < 0.0001 except for SDS (P = 0.0005)). Improvements on dyspeptic symptoms persist during follow-up (better in the treatment group). Acupuncture with manual manipulation had better effects on improving dyspeptic symptoms, mental status, and quality of life in patients with FD. These effects may be related to the increased frequency and propagation speed of gastric slow waves and serum gastrin secretion. PMID:26294930

  3. WTEC panel report on European nuclear instrumentation and controls

    NASA Technical Reports Server (NTRS)

    White, James D.; Lanning, David D.; Beltracchi, Leo; Best, Fred R.; Easter, James R.; Oakes, Lester C.; Sudduth, A. L.

    1991-01-01

    Control and instrumentation systems might be called the 'brain' and 'senses' of a nuclear power plant. As such they become the key elements in the integrated operation of these plants. Recent developments in digital equipment have allowed a dramatic change in the design of these instrument and control (I&C) systems. New designs are evolving with cathode ray tube (CRT)-based control rooms, more automation, and better logical information for the human operators. As these new advanced systems are developed, various decisions must be made about the degree of automation and the human-to-machine interface. Different stages of the development of control automation and of advanced digital systems can be found in various countries. The purpose of this technology assessment is to make a comparative evaluation of the control and instrumentation systems that are being used for commercial nuclear power plants in Europe and the United States. This study is limited to pressurized water reactors (PWR's). Part of the evaluation includes comparisons with a previous similar study assessing Japanese technology.

  4. Tobacco Control and Health Advocacy in the European Union: Understanding Effective Coalition-Building

    PubMed Central

    Collin, Jeff; Amos, Amanda

    2016-01-01

    Introduction: Coalitions of supporters of comprehensive tobacco control policy have been crucial in achieving policy success nationally and internationally, but the dynamics of such alliances are not well understood. Methods: Qualitative semi-structured, narrative interviews with 35 stakeholders involved in developing the European Council Recommendation on smoke-free environments. These were thematically analyzed to examine the dynamics of coalition-building, collaboration and leadership in the alliance of organizations which successfully called for the development of comprehensive European Union (EU) smoke-free policy. Results: An alliance of tobacco control and public health advocacy organizations, scientific institutions, professional bodies, pharmaceutical companies, and other actors shared the goal of fighting the harms caused by second-hand smoke. Alliance members jointly called for comprehensive EU smoke-free policy and the protection of the political debates from tobacco industry interference. The alliance’s success was enabled by a core group of national and European actors with long-standing experience in tobacco control, who facilitated consensus-building, mobilized allies and synchronized the actions of policy supporters. Representatives of Brussels-based organizations emerged as crucial strategic leaders. Conclusions: The insights gained and identification of key enablers of successful tobacco control advocacy highlight the strategic importance of investing into tobacco control at European level. Those interested in effective health policy can apply lessons learned from EU smoke-free policy to build effective alliances in tobacco control and other areas of public health. PMID:25634938

  5. Shading as a Control Method for Invasive European Frogbit (Hydrocharis morsus-ranae L.)

    PubMed Central

    Zhu, Bin; Ellis, Michael S.; Fancher, Kelly L.; Rudstam, Lars G.

    2014-01-01

    Invasive European frogbit (Hydrocharis morsus-ranae L.) has negative environmental and economic impacts in North American water bodies. It is therefore important to develop effective management tools to control this invasive species. This study investigated shading as a control method for European frogbit in both greenhouse and lake mesocosm experiments. A series of shade treatments (0%, 50%, 60%, 70%, 80%, and 100%) were tested in the greenhouse for three weeks. Results showed that the 100% shade was most effective at controlling European frogbit, and other shade treatments greater than 50% were less effective, reducing frogbit biomass up to 38.2%. There were no differences found in temperature between treatments, but dissolved oxygen decreased as shading increased. A lake mesocosm experiment utilizing 0% shade, 70% shade, and 100% shade treatments was performed in a sheltered inlet of Oneida Lake in New York State for over one month. Resulting European frogbit biomass was significantly (25 times) less in areas treated with the 70% shade and nearly zero with the 100% shade. Shading did not affect temperature but improved DO conditions. Results on the shading effects on submerged macrophytes were not conclusive: no significant differences in changes in species richness and abundance between the three groups at the end of studied period suggested no shading effects; significant differences between the beginning and end communities in the 70% shade and the 100% shade but not in the control group indicated significant impacts of shading. This study is the first one to investigate shading as a control method for European frogbit and it is concluded that a moderately high density shade can effective remove European frogbit likely with minor impacts on the environment. More experiments with larger scales and longer time periods are recommended for further investigation. PMID:24886916

  6. A Randomized Controlled Trial of a Behavioral Economic Supplement to Brief Motivational Interventions for College Drinking

    PubMed Central

    Murphy, James G.; Dennhardt, Ashley A.; Skidmore, Jessica R.; Borsari, Brian; Barnett, Nancy P.; Colby, Suzanne M.; Martens, Matthew P.

    2012-01-01

    Objective Behavioral economic theory suggests that a reduction in substance use is most likely when there is an increase in rewarding substance-free activities. The goal of this randomized controlled clinical trial was to evaluate the incremental efficacy of a novel behavioral economic supplement (Substance-Free Activity Session, SFAS) to a standard alcohol brief motivational interviewing (BMI) session for heavy drinking college students. Method Participants were 82 first-year college students (50% female, 81.7% White/European American, Mean age = 18.5 years, SD = .71) who reported two or more past-month heavy drinking episodes. After completing a baseline assessment and an individual alcohol-focused BMI, participants were randomized to either the SFAS or to a Relaxation Training (RT) control session. The SFAS was delivered in an MI style and attempted to increase the salience of delayed academic and career rewards and the patterns of behavior leading to those rewards. Results The combination of an alcohol BMI plus the SFAS was associated with significantly greater reductions in alcohol problems compared to an alcohol BMI plus RT at the 1-month and 6-month follow-up assessments (p = .015, ηp2 = .07), an effect that was partially mediated by increases in protective behavioral strategies. BMI + SFAS was also associated with greater reductions in heavy drinking among participants who at baseline reported low levels of substance-free reinforcement or symptoms of depression. Conclusion These results are consistent with behavioral economic theory and suggest that a single session focused on increasing engagement in alternatives to drinking can enhance the effects of brief alcohol interventions. PMID:22663899

  7. Spinal cord stimulation with interleaved pulses: a randomized, controlled trial.

    PubMed

    North, Richard B; Kidd, David H; Olin, John; Sieracki, Jeffrey M; Boulay, Marc

    2007-10-01

    Objectives.  The development of multicontact electrodes and programmable, implanted pulse generators has increased the therapeutic success of spinal cord stimulation (SCS) by enhancing the ability to capture and maintain pain/paresthesia overlap. This study sought to determine if interleaved stimulation and/or frequency doubling improves pain/paresthesia overlap in patients with failed back surgery syndrome. Methods.  Using a patient-interactive computer system that quantifies SCS performance and presents stimulation settings in randomized, double-blind fashion, we compared the effect on pain/paresthesia overlap of interleaved stimulation (rapidly interleaved pulse trains using two different contact combinations) vs. standard treatment with a single contact combination, controlling for frequency doubling. Stimulation amplitude (charge per phase, as determined by varying pulse voltage or width) was adjusted to a subjectively comfortable intensity (usage amplitude), which was maintained for all trials in each patient. The number of percutaneous spinal electrodes used (one or two) and the phase angle between interleaved pulses were additional study variables. Results.  Multivariate analysis of 266 test results from 15 patients revealed a statistically significant (p ≤ 0.05) association between increased computer-calculated pain/paresthesia overlap and 1) high- and low-frequency interleaved stimulation using two combinations of contacts and 2) frequency doubling using one combination. We found no significant effect for electrode configuration (single or dual), pulse width matching, or phase angle. Conclusions.  The statistically significant advantages we observed for SCS with interleaved stimulation are explained, at least in part, by the effects of frequency doubling. These findings have important implications for the design and adjustment of pulse generators. PMID:22150894

  8. Tryptophan Supplementation and Postoperative Delirium – A Randomized Controlled Trial

    PubMed Central

    Robinson, Thomas N.; Dunn, Christina L.; Adams, Jill C.; Hawkins, Carrie L.; Tran, Zung V.; Raeburn, Christopher D.; Moss, Marc

    2014-01-01

    Background/Objectives Tryptophan deficiency has been associated with increased incidence of postoperative delirium. Therefore, we hypothesized that the post-operative administration of tryptophan would be beneficial for elderly surgical patients who are at higher risk of developing post-operative delirium. Design Randomized, double-blind, placebo controlled trial. Setting: Participants A total of 325 individuals aged 60 years and older undergoing major elective operations requiring a postoperative intensive care unit admission. Intervention L-tryptophan, 1 gram orally, three times daily or placebo was started following the operation and continued for up to three days postoperatively. Measurements Delirium and its motor subtypes were measured using the Confusion Assessment Method-ICU and the Richmond Agitation and Sedation Scale. The primary outcome for between groups comparison was the incidence of excitatory (mixed and hyperactive) postoperative delirium. The secondary outcomes for comparison were the incidence and duration of overall postoperative delirium. Results The overall incidence of postoperative delirium was 39% (116) (95% confidence interval 34% to 44%). The percentages of patients with excitatory delirium in the tryptophan and placebo groups were 17% and 9% (p=0.176), and the duration of excitatory delirium was 3.3±1.7 and 3.1±1.9 days (p=0.741). The percentage of patients with overall delirium in the tryptophan and placebo groups was 40% and 37% (p=0.597), and the duration of overall delirium was 2.9±1.8 and 2.4±1.6 days (p=0.167). Conclusion Postoperative tryptophan supplementation in older adults undergoing major elective operations requiring postoperative intensive care unit admission demonstrated no efficacy in reducing the incidence of postoperative excitatory delirium or overall delirium, and the duration of excitatory or overall delirium. PMID:25112175

  9. The selection and design of control conditions for randomized controlled trials of psychological interventions.

    PubMed

    Mohr, David C; Spring, Bonnie; Freedland, Kenneth E; Beckner, Victoria; Arean, Patricia; Hollon, Steven D; Ockene, Judith; Kaplan, Robert

    2009-01-01

    The randomized controlled trial (RCT) provides critical support for evidence-based practice using psychological interventions. The control condition is the principal method of removing the influence of unwanted variables in RCTs. There is little agreement or consistency in the design and construction of control conditions. Because control conditions have variable effects, the results of RCTs can depend as much on control condition selection as on the experimental intervention. The aim of this paper is to present a framework for the selection and design of control conditions for these trials. Threats to internal validity arising from modern RCT methodology are reviewed and reconsidered. The strengths and weaknesses of several categories of control conditions are examined, including the ones that are under experimental control, the ones that are under the control of clinical service providers, and no-treatment controls. Considerations in the selection of control conditions are discussed and several recommendations are proposed. The aim of this paper is to begin to define principles by which control conditions can be selected or developed in a manner that can assist both investigators and grant reviewers.

  10. Aspects of the Acquisition of Object Control and ECM-Type Verbs in European Portuguese

    ERIC Educational Resources Information Center

    Santos, Ana Lúcia; Gonçalves, Anabela; Hyams, Nina

    2016-01-01

    We investigate the acquisition of sentential complementation under causative, perception, and object control verbs in European Portuguese, a language rich in complement types, including the typologically marked inflected infinitives. We tested 58 children between 3 and 5 years of age and 24 adults on a sentence completion task. The results support…

  11. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  12. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial

    PubMed Central

    Ware, Mark A.; Wang, Tongtong; Shapiro, Stan; Robinson, Ann; Ducruet, Thierry; Huynh, Thao; Gamsa, Ann; Bennett, Gary J.; Collet, Jean-Paul

    2010-01-01

    Background Chronic neuropathic pain affects 1%–2% of the adult population and is often refractory to standard pharmacologic treatment. Patients with chronic pain have reported using smoked cannabis to relieve pain, improve sleep and improve mood. Methods Adults with post-traumatic or postsurgical neuropathic pain were randomly assigned to receive cannabis at four potencies (0%, 2.5%, 6% and 9.4% tetrahydrocannabinol) over four 14-day periods in a crossover trial. Participants inhaled a single 25-mg dose through a pipe three times daily for the first five days in each cycle, followed by a nine-day washout period. Daily average pain intensity was measured using an 11-point numeric rating scale. We recorded effects on mood, sleep and quality of life, as well as adverse events. Results We recruited 23 participants (mean age 45.4 [standard deviation 12.3] years, 12 women [52%]), of whom 21 completed the trial. The average daily pain intensity, measured on the 11-point numeric rating scale, was lower on the prespecified primary contrast of 9.4% v. 0% tetrahydrocannabinol (5.4 v. 6.1, respectively; difference = 0.7, 95% confidence interval [CI] 0.02–1.4). Preparations with intermediate potency yielded intermediate but nonsignificant degrees of relief. Participants receiving 9.4% tetrahydrocannabinol reported improved ability to fall asleep (easier, p = 0.001; faster, p < 0.001; more drowsy, p = 0.003) and improved quality of sleep (less wakefulness, p = 0.01) relative to 0% tetrahydrocannabinol. We found no differences in mood or quality of life. The most common drug-related adverse events during the period when participants received 9.4% tetrahydrocannabinol were headache, dry eyes, burning sensation in areas of neuropathic pain, dizziness, numbness and cough. Conclusion A single inhalation of 25 mg of 9.4% tetrahydrocannabinol herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep and was well tolerated. Further long

  13. 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. PMID:26125397

  14. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    PubMed Central

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  15. Adaptive randomized algorithms for analysis and design of control systems under uncertain environments

    NASA Astrophysics Data System (ADS)

    Chen, Xinjia

    2015-05-01

    We consider the general problem of analysis and design of control systems in the presence of uncertainties. We treat uncertainties that affect a control system as random variables. The performance of the system is measured by the expectation of some derived random variables, which are typically bounded. We develop adaptive sequential randomized algorithms for estimating and optimizing the expectation of such bounded random variables with guaranteed accuracy and confidence level. These algorithms can be applied to overcome the conservatism and computational complexity in the analysis and design of controllers to be used in uncertain environments. We develop methods for investigating the optimality and computational complexity of such algorithms.

  16. Identifying components for programmatic latent tuberculosis infection control in the European Union.

    PubMed

    Sandgren, Andreas; Vonk Noordegraaf-Schouten, Jannigje M; Oordt-Speets, Anouk M; van Kessel, Gerarda B; de Vlas, Sake J; van der Werf, Marieke J

    2016-08-25

    Individuals with latent tuberculosis infection (LTBI) are the reservoir of Mycobacterium tuberculosis in a population and as long as this reservoir exists, elimination of tuberculosis (TB) will not be feasible. In 2013, the European Centre for Disease Prevention and Control (ECDC) started an assessment of benefits and risks of introducing programmatic LTBI control, with the aim of providing guidance on how to incorporate LTBI control into national TB strategies in European Union/European Economic Area (EU/EEA) Member States and candidate countries. In a first step, experts from the Member States, candidate countries, and international and national organisations were consulted on the components of programmatic LTBI control that should be considered and evaluated in literature reviews, mathematical models and cost-effectiveness studies. This was done through a questionnaire and two interactive discussion rounds. The main components identified were identification and targeting of risk groups, determinants of LTBI and progression to active TB, optimal diagnostic tests for LTBI, effective preventive treatment regimens, and to explore the potential for combining LTBI control with other health programmes. Political commitment, a solid healthcare infrastructure, and favourable economic situation in specific countries were identified as essential to facilitate the implementation of programmatic LTBI control.

  17. Identifying components for programmatic latent tuberculosis infection control in the European Union.

    PubMed

    Sandgren, Andreas; Vonk Noordegraaf-Schouten, Jannigje M; Oordt-Speets, Anouk M; van Kessel, Gerarda B; de Vlas, Sake J; van der Werf, Marieke J

    2016-08-25

    Individuals with latent tuberculosis infection (LTBI) are the reservoir of Mycobacterium tuberculosis in a population and as long as this reservoir exists, elimination of tuberculosis (TB) will not be feasible. In 2013, the European Centre for Disease Prevention and Control (ECDC) started an assessment of benefits and risks of introducing programmatic LTBI control, with the aim of providing guidance on how to incorporate LTBI control into national TB strategies in European Union/European Economic Area (EU/EEA) Member States and candidate countries. In a first step, experts from the Member States, candidate countries, and international and national organisations were consulted on the components of programmatic LTBI control that should be considered and evaluated in literature reviews, mathematical models and cost-effectiveness studies. This was done through a questionnaire and two interactive discussion rounds. The main components identified were identification and targeting of risk groups, determinants of LTBI and progression to active TB, optimal diagnostic tests for LTBI, effective preventive treatment regimens, and to explore the potential for combining LTBI control with other health programmes. Political commitment, a solid healthcare infrastructure, and favourable economic situation in specific countries were identified as essential to facilitate the implementation of programmatic LTBI control. PMID:27589214

  18. Building Kindergartners' Number Sense: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small-group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to 1 of 3 groups (n = 44 in each…

  19. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  20. Efficacy of the "Responsive Classroom" Approach: Results from a 3-Year, Longitudinal Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rimm-Kaufman, Sara E.; Larsen, Ross A. A.; Baroody, Alison E.; Curby, Timothy W.; Ko, Michelle; Thomas, Julia B.; Merritt, Eileen G.; Abry, Tashia; DeCoster, Jamie

    2014-01-01

    This randomized controlled field trial examined the efficacy of the Responsive Classroom (RC) approach on student achievement. Schools (n = 24) were randomized into intervention and control conditions; 2,904 children were studied from end of second to fifth grade. Students at schools assigned to the RC condition did not outperform students at…

  1. Intention-to-Treat Analysis in Partially Nested Randomized Controlled Trials with Real-World Complexity

    ERIC Educational Resources Information Center

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

    Demands for scientific knowledge of what works in educational policy and practice has driven interest in quantitative investigations of educational outcomes, and randomized controlled trials (RCTs) have proliferated under these conditions. In educational settings, even when individuals are randomized, both experimental and control students are…

  2. Meta-Analysis of Randomized, Controlled Treatment Trials for Pediatric Obsessive-Compulsive Disorder

    ERIC Educational Resources Information Center

    Watson, Hunna J.; Rees, Clare S.

    2008-01-01

    Objective: To conduct a meta-analysis on randomized, controlled treatment trials of pediatric obsessive-compulsive disorder (OCD). Method: Studies were included if they employed randomized, controlled methodology and treated young people (19 years or under) with OCD. A comprehensive literature search identified 13 RCTs containing 10…

  3. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    ERIC Educational Resources Information Center

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  4. Key Items to Get Right When Conducting a Randomized Controlled Trial in Education

    ERIC Educational Resources Information Center

    Coalition for Evidence-Based Policy, 2005

    2005-01-01

    This is a checklist of key items to get right when conducting a randomized controlled trial to evaluate an educational program or practice ("intervention"). It is intended as a practical resource for researchers and sponsors of research, describing items that are often critical to the success of a randomized controlled trial. A significant…

  5. A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

    ERIC Educational Resources Information Center

    Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

    2012-01-01

    This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

  6. Conceptual design of the control software for the European Solar Telescope

    NASA Astrophysics Data System (ADS)

    Di Marcantonio, P.; Cirami, R.; Romano, P.; Cosentino, R.; Ermolli, I.; Giorgi, F.

    2012-09-01

    Aim of this paper is to present an overview of the conceptual design of the Control Software for the European Solar Telescope (EST), as emerged after the successful Conceptual Design Review held in June 2011 which formally concluded the EST Preliminary Design Study. After a general description of ECS (EST Control Software) architecture end-to-end, from operation concepts and observation preparations to the control of the planned focal plane instruments, the paper focuses on the arrangement devised to date of ECS to cope with the foreseen scientific requirements. EST major subsystems together with the functions to be controlled are eventually detailed and discussed.

  7. Controlling Random Lasing with Three-Dimensional Plasmonic Nanorod Metamaterials.

    PubMed

    Wang, Zhuoxian; Meng, Xiangeng; Choi, Seung Ho; Knitter, Sebastian; Kim, Young L; Cao, Hui; Shalaev, Vladimir M; Boltasseva, Alexandra

    2016-04-13

    Plasmonics has brought revolutionary advances to laser science by enabling deeply subwavelength nanolasers through surface plasmon amplification. However, the impact of plasmonics on other promising laser systems has so far remained elusive. Here, we present a class of random lasers enabled by three-dimensional plasmonic nanorod metamaterials. While dense metallic nanostructures are usually detrimental to laser performance due to absorption losses, here the lasing threshold keeps decreasing as the volume fraction of metal is increased up to ∼0.07. This is ∼460 times higher than the optimal volume fraction reported thus far. The laser supports spatially confined lasing modes and allows for efficient modulation of spectral profiles by simply tuning the polarization of the pump light. Full-field speckle-free imaging at micron-scales has been achieved by using plasmonic random lasers as the illumination sources. Our findings show that plasmonic metamaterials hold potential to enable intriguing coherent optical sources.

  8. Controlling Random Lasing with Three-Dimensional Plasmonic Nanorod Metamaterials.

    PubMed

    Wang, Zhuoxian; Meng, Xiangeng; Choi, Seung Ho; Knitter, Sebastian; Kim, Young L; Cao, Hui; Shalaev, Vladimir M; Boltasseva, Alexandra

    2016-04-13

    Plasmonics has brought revolutionary advances to laser science by enabling deeply subwavelength nanolasers through surface plasmon amplification. However, the impact of plasmonics on other promising laser systems has so far remained elusive. Here, we present a class of random lasers enabled by three-dimensional plasmonic nanorod metamaterials. While dense metallic nanostructures are usually detrimental to laser performance due to absorption losses, here the lasing threshold keeps decreasing as the volume fraction of metal is increased up to ∼0.07. This is ∼460 times higher than the optimal volume fraction reported thus far. The laser supports spatially confined lasing modes and allows for efficient modulation of spectral profiles by simply tuning the polarization of the pump light. Full-field speckle-free imaging at micron-scales has been achieved by using plasmonic random lasers as the illumination sources. Our findings show that plasmonic metamaterials hold potential to enable intriguing coherent optical sources. PMID:27023052

  9. PREFACE: 12th European Workshop on Advanced Control and Diagnosis (ACD 2015)

    NASA Astrophysics Data System (ADS)

    Straka, Ondřej; Punčochář, Ivo; Duník, Jindřich

    2015-11-01

    The 12th European Workshop on Advanced Control and Diagnosis (ACD 2015) took place at the Research Centre NTIS - New Technologies for the Information Society, Faculty of Applied Sciences, University of West Bohemia, Pilsen, Czech Republic, on November 19 - 20, 2015. The annual European Workshop on Advanced Control and Diagnosis has been organized since 2003 by Control Engineering departments of several European universities in Germany, France, the UK, Poland, Italy, Hungary, and Denmark to bring together senior and junior academics and engineers from diverse fields of automatic control, fault detection, and signal processing. The workshop provides an opportunity for researchers and developers to present their recent theoretical developments, practical applications, or even open problems. It also offers a great opportunity for industrial partners to express their needs and priorities and to review the current activities in the fields. A total of 74 papers have been submitted for ACD 2015. Based on the peer reviews 48 papers were accepted for the oral presentation and 10 papers for the poster presentation. The accepted papers covered areas of control theory and applications, identification, estimation, signal processing, and fault detection. In addition, four excellent plenary lectures were delivered by Prof. Fredrik Gustafsson (Automotive Sensor Mining for Tire Pressure Monitoring), Prof. Vladimír Havlena (Advanced Process Control for Energy Efficiency), Prof. Silvio Simani (Advanced Issues on Wind Turbine Modelling and Control), and Prof. Robert Babuška (Learning Control in Robotics). The ACD 2015 was for the first time in the workshop history co-sponsored by the International Federation of Automatic Control (IFAC). On behalf of the ACD 2015 organising committee, we would like to thank all those who prepared and submitted papers, participated in the peer review process, supported, and attended the workshop.

  10. Eliminating bias in randomized controlled trials: importance of allocation concealment and masking.

    PubMed

    Viera, Anthony J; Bangdiwala, Shrikant I

    2007-02-01

    Randomization in randomized controlled trials involves more than generation of a random sequence by which to assign subjects. For randomization to be successfully implemented, the randomization sequence must be adequately protected (concealed) so that investigators, involved health care providers, and subjects are not aware of the upcoming assignment. The absence of adequate allocation concealment can lead to selection bias, one of the very problems that randomization was supposed to eliminate. Authors of reports of randomized trials should provide enough details on how allocation concealment was achieved so the reader can determine the likelihood of success. Fortunately, a plan of allocation concealment can always be incorporated into the design of a randomized trial. Certain methods minimize the risk of concealment failing more than others. Keeping knowledge of subjects' assignment after allocation from subjects, investigators/health care providers, or those assessing outcomes is referred to as masking (also known as blinding). The goal of masking is to prevent ascertainment bias. In contrast to allocation concealment, masking cannot always be incorporated into a randomized controlled trial. Both allocation concealment and masking add to the elimination of bias in randomized controlled trials.

  11. Combined aerobic and resistance training in breast cancer survivors: A randomized, controlled pilot trial.

    PubMed

    Herrero, F; San Juan, A F; Fleck, S J; Balmer, J; Pérez, M; Cañete, S; Earnest, C P; Foster, C; Lucía, A

    2006-07-01

    The purpose of this pilot study was to examine the effects of a combined cardiorespiratory and resistance exercise training program of short duration on the cardiorespiratory fitness, strength endurance, task specific functional muscle capacity, body composition and quality of life (QOL) in women breast cancer survivors. Sixteen subjects were randomly assigned to either a training (n = 8; age: 50 +/- 5 yrs) or control non-exercising group (n = 8; age: 51 +/- 10 yrs). The training group followed an 8-week exercise program consisting of 3 weekly sessions of 90-min duration, supervised by an experienced investigator and divided into resistance exercises and aerobic training. Before and after the intervention period, all of the subjects performed a cardiorespiratory test to measure peak oxygen uptake (VO2peak), a dynamic strength endurance test (maximum number of repetitions for chest and leg press exercise at 30 - 35 % and 100 - 110 % of body mass, respectively) and a sit-stand test. Quality of life was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC-C30) questionnaire. In response to training, QOL, VO2peak (mean 3.9 ml/kg/min; 95 % CI, 0.93, 6.90) performance in leg press (17.9 kg; 95 % CI, 12.8, 22.4) and sit-stand test (- 0.67 s; 95 % CI, - 0.52, - 1.2) improved (p < or = 0.05). We observed no significant changes in the control group. Combined cardiorespiratory and resistance training, even of very brief duration, improves the QOL and the overall physical fitness of women breast cancer survivors.

  12. Acid rain and photochemical oxidants control policies in the European community: A decision analysis framework

    NASA Astrophysics Data System (ADS)

    Bell, Sarah; Raymond, Karen; Watson, Stephen; Wenman, Paul

    The methodology and key findings are presented of a study to evaluate costs and benefits of alternative acid rain control strategies to be implemented at a European Community level between 1980 and 2000. The methodology adopted was decision analysis whose key advantage is an explicit consideration of uncertainty. Benefits predicted under some of the control strategies were found to be significantly greater than those predicted for the 'no control' case, particularly for lakes; urban environmental quality was only expected to improve greatly under the strategy that specifically targeted urban emissions; predictions for crops and forests were relatively uncertain due to inadequacies in the measurement and modelling of ozone.

  13. Mosquito-borne disease surveillance by the European Centre for Disease Prevention and Control.

    PubMed

    Zeller, H; Marrama, L; Sudre, B; Van Bortel, W; Warns-Petit, E

    2013-08-01

    For a few years, a series of traditionally tropical mosquito-borne diseases, such as chikungunya fever and dengue, have posed challenges to national public health authorities in the European region. Other diseases have re-emerged, e.g. malaria in Greece, or spread to other countries, e.g. West Nile fever. These diseases are reportable within the European Union (EU), and the European Centre for Disease Prevention and Control collects information in various ways to provide EU member states with topical assessments of disease threats, risks and trends for prompt and appropriate public health action. Using disease-specific expert networks, the European Surveillance System (TESSy) collects standardized comparable information on all statutory communicable diseases in a database. In addition, the event-based surveillance aims to detect potential public health threats early, and to allow timely response and support to blood deferral decisions for pathogens that can be transmitted through blood donation. Laboratory capacity for early detection is implemented through external quality assessments. Other activities include the development of guidelines for the surveillance of mosquito vectors, and the production of regularly updated maps on the currently known occurrence of mosquito vector species.

  14. Control problem for diffusion-type random fields

    SciTech Connect

    Knopov, P.S.; Derieva, E.N.

    1995-09-01

    Sufficient existence conditions are given for optimal control in a system described by a stochastic differential equations. These conditions are derived by Girsanov`s method of transformation of measures. Existence of {epsilon}-optimal controls is proved and a method of their construction is described.

  15. A Randomized Controlled Trial of Brief Interventions for Body Dissatisfaction

    ERIC Educational Resources Information Center

    Wade, Tracey; George, Wing Man; Atkinson, Melissa

    2009-01-01

    The authors examined the relative effectiveness of 3 different approaches to the experience of body dissatisfaction compared to a control and ruminative attention control condition, with respect to increasing weight and appearance satisfaction. One hundred female undergraduates (mean age = 24.38, SD = 9.39) underwent a body dissatisfaction…

  16. Topical treatment of tungiasis: a randomized, controlled trial.

    PubMed

    Heukelbach, J; Eisele, M; Jackson, A; Feldmeier, H

    2003-10-01

    Tungiasis is caused by the penetration of the female sand flea Tunga penetrans into the epidermis of its host. Human infestation with this ectoparasite is hyper-endemic in many resource-poor communities in sub-Saharan Africa, the Caribbean and South America and is associated with considerable morbidity. Currently, there is no effective drug available to treat tungiasis (or at least none for which a parasiticidal effect has been clearly demonstrated). In an attempt to fill this gap, the effects of treatment with topical ivermectin (lotion), thiabendazole (ointment and lotion), metrifonate (lotion) or placebo lotion were compared in a randomized trial. A total of 108 subjects with 169 tungiasis-infested feet participated in the study. The results show that topical ivermectin, metrifonate or thiabendazole can each significantly reduce the number of lesions caused by embedded sand fleas. Further studies are needed to optimise the doses and administration of these compounds.

  17. Progesterone Receptor Modulator for Emergency Contraception: A Randomized Controlled Trial

    PubMed Central

    Creinin, Mitchell D.; Schlaff, William; Archer, David F.; Wan, Livia; Frezieres, Ron; Thomas, Michael; Rosenberg, Michael; Higgins, James

    2010-01-01

    Objective Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception. Methods We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of levonorgestrel taken 12 hours apart. Follow-up was scheduled 5 to 7 days after the expected onset of the next menstrual period. Posttreatment pregnancy was established by a positive urine test at follow-up and confirmed by quantitative serum β-hCG. Daily diaries were used from the time of emergency contraception use until next menses to record adverse effects and sexual activity. Results Product efficacy was evaluable in 775 of CDB-2914 users and 774 of levonorgestrel users. Pregnancies occurred in 7 (0.9%, 95% confidence interval 0.2–1.6%) and 13 (1.7%, 95% confidence interval 0.8–2.6%) women, respectively. Based on the estimated cycle day of unprotected intercourse, 85% and 69% of anticipated pregnancies, respectively, were averted. Nausea was reported by a somewhat greater percentage of CDB-2914 than levonorgestrel users (29% compared with 24%, P=.03), but the distribution of other adverse effects was similar in both groups. Women in both groups experienced considerable variation in menstrual cycle length as compared with their reported individual normal cycle lengths. Conclusion CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile. PMID:17077229

  18. Complementary feeding: a Global Network cluster randomized controlled trial

    PubMed Central

    2011-01-01

    Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale

  19. Effects of the FITKids Randomized Controlled Trial on Executive Control and Brain Function

    PubMed Central

    Pontifex, Matthew B.; Castelli, Darla M.; Khan, Naiman A.; Raine, Lauren B.; Scudder, Mark R.; Drollette, Eric S.; Moore, Robert D.; Wu, Chien-Ting; Kamijo, Keita

    2014-01-01

    OBJECTIVE: To assess the effect of a physical activity (PA) intervention on brain and behavioral indices of executive control in preadolescent children. METHODS: Two hundred twenty-one children (7–9 years) were randomly assigned to a 9-month afterschool PA program or a wait-list control. In addition to changes in fitness (maximal oxygen consumption), electrical activity in the brain (P3-ERP) and behavioral measures (accuracy, reaction time) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility. RESULTS: Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control (1.3 mL/kg per minute, 95% confidence interval [CI]: 0.3 to 2.4; d = 0.34 for group difference in pre-to-post change score). Intervention participants exhibited greater improvements from pretest to posttest in inhibition (3.2%, 95% CI: 0.0 to 6.5; d = 0.27) and cognitive flexibility (4.8%, 95% CI: 1.1 to 8.4; d = 0.35 for group difference in pre-to-post change score) compared with control. Only the intervention group increased attentional resources from pretest to posttest during tasks requiring increased inhibition (1.4 µV, 95% CI: 0.3 to 2.6; d = 0.34) and cognitive flexibility (1.5 µV, 95% CI: 0.6 to 2.5; d = 0.43). Finally, improvements in brain function on the inhibition task (r = 0.22) and performance on the flexibility task correlated with intervention attendance (r = 0.24). CONCLUSIONS: The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control. These findings demonstrate a causal effect of a PA program on executive control, and provide support for PA for improving childhood cognition and brain health. PMID:25266425

  20. Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

    ERIC Educational Resources Information Center

    Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

    2015-01-01

    Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

  1. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    ERIC Educational Resources Information Center

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  2. Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

    ERIC Educational Resources Information Center

    Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

    2009-01-01

    When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

  3. The Late Pretest Problem in Randomized Control Trials of Education Interventions. NCEE 2009-4033

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2008-01-01

    Pretest-posttest experimental designs are often used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data are often collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  4. The Late Pretest Problem in Randomized Control Trials of Education Interventions

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2010-01-01

    Pretest-posttest experimental designs often are used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data often are collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  5. Effect of Art Production on Negative Mood: A Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Bell, Chloe E.; Robbins, Steven J.

    2007-01-01

    Art therapists have long held that art production causes reductions in stress and elevations in mood (Rubin, 1999). The authors examined this claim in a randomized, controlled trial. Fifty adults between the ages of 18 and 30 were randomly assigned to either create an art work or to view and sort a series of art prints. Three measures of overall…

  6. A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

    ERIC Educational Resources Information Center

    Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

    2012-01-01

    This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

  7. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  8. What to Do when Data Are Missing in Group Randomized Controlled Trials. NCEE 2009-0049

    ERIC Educational Resources Information Center

    Puma, Michael J.; Olsen, Robert B.; Bell, Stephen H.; Price, Cristofer

    2009-01-01

    This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups of students such as entire classrooms or schools are randomized. Missing outcome data are a…

  9. Implementation of the Orbital Maneuvering Systems Engine and Thrust Vector Control for the European Service Module

    NASA Technical Reports Server (NTRS)

    Millard, Jon

    2014-01-01

    The European Space Agency (ESA) has entered into a partnership with the National Aeronautics and Space Administration (NASA) to develop and provide the Service Module (SM) for the Orion Multipurpose Crew Vehicle (MPCV) Program. The European Service Module (ESM) will provide main engine thrust by utilizing the Space Shuttle Program Orbital Maneuvering System Engine (OMS-E). Thrust Vector Control (TVC) of the OMS-E will be provided by the Orbital Maneuvering System (OMS) TVC, also used during the Space Shuttle Program. NASA will be providing the OMS-E and OMS TVC to ESA as Government Furnished Equipment (GFE) to integrate into the ESM. This presentation will describe the OMS-E and OMS TVC and discuss the implementation of the hardware for the ESM.

  10. Balneotherapy for chronic low back pain: a randomized, controlled study.

    PubMed

    Kesiktas, Nur; Karakas, Sinem; Gun, Kerem; Gun, Nuran; Murat, Sadiye; Uludag, Murat

    2012-10-01

    A large number of treatments were used for patients with chronic low back pain. Frequent episodes have been reported very high. Although balneotherapy was found effective in this disease, there are not well-designed studies. We aimed to determine the effectiveness of balneotherapy versus physical therapy in patients with chronic low back pain. Exercise was added to both treatment programs. Sixty patients with chronic low back pain were randomly divided into two groups. Physical modalities plus exercise were applied to group 1, and group 2 was received balneotherapy plus exercise for ten sessions. The following parameters were measured: visual analogue scale at rest and movement for pain, paracetamol dose, manual muscle test for lumber muscles, modified Schoeber' test, Oswestry disability index, and Short-Form 36 at the beginning and end of the therapies and at the 3 months follow-up. The statistical analyses were performed using the SPSS 10.0 program. Both groups achieved significant improvements within themselves. But balneotherapy groups were improved at back extensor muscle test (P < 0.05), modified Schoeber's test (P < 0.03), Oswestry disability index, and the some scores of SF 36 (energy vitality, social function, role limitations related to physical problems, and general health P < 0.05). Balneotherapy combined with exercise therapy had advantages than therapy with physical modalities plus exercise in improving quality of life and flexibility of patients with chronic low back pain.

  11. Brief cognitive therapy for panic disorder: a randomized controlled trial.

    PubMed

    Clark, D M; Salkovskis, P M; Hackmann, A; Wells, A; Ludgate, J; Gelder, M

    1999-08-01

    Cognitive therapy (CT) is a specific and highly effective treatment for panic disorder (PD). Treatment normally involves 12-15 1-hr sessions. In an attempt to produce a more cost-effective version, a briefer treatment that made extensive use of between-sessions patient self-study modules was created. Forty-three PD patients were randomly allocated to full CT (FCT), brief CT (BCT), or a 3-month wait list. FCT and BCT were superior to wait list on all measures, and the gains obtained in treatment were maintained at 12-month follow-up. There were no significant differences between FCT and BCT. Both treatments had large (approximately 3.0) and essentially identical effect sizes. BCT required 6.5 hr of therapist time, including booster sessions. Patients' initial expectation of therapy success was negatively correlated with posttreatment panic-anxiety. Cognitive measures at the end of treatment predicted panic-anxiety at 12-month follow-up. PMID:10450630

  12. Deterministic quasi-random nanostructures for photon control.

    PubMed

    Martins, Emiliano R; Li, Juntao; Liu, YiKun; Depauw, Valérie; Chen, Zhanxu; Zhou, Jianying; Krauss, Thomas F

    2013-01-01

    Controlling the flux of photons is crucial in many areas of science and technology. Artificial materials with nano-scale modulation of the refractive index, such as photonic crystals, are able to exercise such control and have opened exciting new possibilities for light manipulation. An interesting alternative to such periodic structures is the class of materials known as quasi-crystals, which offer unique advantages such as richer Fourier spectra. Here we introduce a novel approach for designing such richer Fourier spectra, by using a periodic structure that allows us to control its Fourier components almost at will. Our approach is based on binary gratings, which makes the structures easy to replicate and to tailor towards specific applications. As an example, we show how these structures can be employed to achieve highly efficient broad-band light trapping in thin films that approach the theoretical (Lambertian) limit, a problem of crucial importance for photovoltaics.

  13. Stochastic Control for a Class of Random Evolution Models

    SciTech Connect

    Hongler, Max-Olivier Soner, Halil Mete Streit, Ludwig

    2004-03-15

    We construct the explicit connection existing between a solvable model of the discrete velocities non-linear Boltzmann equation and the Hamilton-Bellman-Jacobi equation associated with a simple optimal control of a piecewise deterministic process. This study extends the known relation that exists between the Burgers equation and a simple controlled diffusion problem. In both cases the resulting partial differential equations can be linearized via a logarithmic transformation and hence offer the possibility to solve physically relevant non-linear field models in full generality.

  14. Behavior Therapy for Pediatric Trichotillomania: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Franklin, Martin E.; Edson, Aubrey L.; Ledley, Deborah A.; Cahill, Shawn P.

    2011-01-01

    Objective: To examine the efficacy and durability of a behavioral therapy (BT) protocol for pediatric TTM compared with a minimal attention control (MAC) condition. It was hypothesized that the BT condition would be superior to MAC at the end of acute treatment, and would also demonstrate durability of gains through the maintenance treatment…

  15. Does Playworks Work? Findings from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    James-Burdumy, Susanne; Bleeker, Martha; Beyler, Nicholas; London, Rebecca A.; Westrich, Lisa; Stokes-Guinan, Katie; Castrechini, Sebastian

    2013-01-01

    Most school principals believe recess has a positive impact on the development of students' social skills and academic achievement. Research also suggests that physical activity and play during recess may be linked to improvements in both academic and prosocial behaviors (Centers for Disease Control and Prevention 2010). Recess, however, has been…

  16. The Pan European Phenological Database PEP725: Data Content and Data Quality Control Procedures

    NASA Astrophysics Data System (ADS)

    Jurkovic, Anita; Hübner, Thomas; Koch, Elisabeth; Lipa, Wolfgang; Scheifinger, Helfried; Ungersböck, Markus; Zach-Hermann, Susanne

    2014-05-01

    Phenology - the study of the timing of recurring biological events in the animal and plant world - has become an important approach for climate change impact studies in recent years. It is therefore a "conditio sine qua non" to collect, archive, digitize, control and update phenological datasets. Thus and with regard to cross-border cooperation and activities it was necessary to establish, operate and promote a pan European phenological database (PEP725). Such a database - designed and tested under cost action 725 in 2004 and further developed and maintained in the framework of the EUMETNET program PEP725 - collects data from different European governmental and nongovernmental institutions and thus offers a unique compilation of plant phenological observations. The data follows the same classification scheme - the so called BBCH coding system - that makes datasets comparable. Europe had a long tradition in the observation of phenological events: the history of collecting phenological data and their usage in climatology began in 1751. The first datasets in PEP725 date back to 1868. However, there are only a few observations available until 1950. From 1951 onwards, the phenological networks all over Europe developed rapidly: Currently, PEP725 provides about 9 million records from 23 European countries (covering approximately 50% of Europe). To supply the data in a good and uniform quality it is essential and worthwhile to establish and develop data quality control procedures. Consequently, one of the main tasks within PEP725 is the conception of a multi-stage-quality control. Currently the tests are stepwise composed: completeness -, plausibility -, time consistency -, climatological - and statistical checks. In a nutshell: The poster exemplifies the status quo of the data content of the PEP725 database and incipient stages of used and planned quality controls, respectively. For more details, we would also like to promote and refer to the PEP725 website (http

  17. Tuberculosis control and economic recession: longitudinal study of data from 21 European countries, 1991–2012

    PubMed Central

    Reeves, Aaron; Basu, Sanjay; McKee, Martin; Sandgren, Andreas; Semenza, Jan C

    2015-01-01

    Abstract Objective To investigate whether the economic recession affected the control of tuberculosis in the European Union. Methods Multivariate regression models were used to quantify the association between gross domestic product, public health expenditure and tuberculosis case detection rates, using data from 21 European Union member states (1991–2012). The estimated changes in case detection attributable to the recession were combined with mathematical models of tuberculosis transmission, to project the potential influence of the recession on tuberculosis epidemiology until 2030. Findings Between 1991 and 2007, detection rates for sputum-smear-positive tuberculosis in the European Union were stable at approximately 85%. During the economic recession (2008–2011) detection rates declined by a mean of 5.22% (95% confidence interval, CI: 2.54–7.90) but treatment success rates showed no significant change (P = 0.62). A fall in economic output of 100 United States dollars per capita was associated with a 0.22% (95% CI: 0.05–0.39) mean reduction in the tuberculosis case detection rate. An equivalent fall in spending on public health services was associated with a 2.74% (95% CI: 0.31–5.16) mean reduction in the detection rate. Mathematical models suggest that the recession and consequent austerity policies will lead to increases in tuberculosis prevalence and tuberculosis-attributable mortality that are projected to persist for over a decade. Conclusion Across the European Union, reductions in spending on public health services appear to have reduced tuberculosis case detection and to have increased the long-term risk of a resurgence in the disease. PMID:26240458

  18. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    ERIC Educational Resources Information Center

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  19. Distributed reservation control protocols for random access broadcasting channels

    NASA Technical Reports Server (NTRS)

    Greene, E. P.; Ephremides, A.

    1981-01-01

    Attention is given to a communication network consisting of an arbitrary number of nodes which can communicate with each other via a time-division multiple access (TDMA) broadcast channel. The reported investigation is concerned with the development of efficient distributed multiple access protocols for traffic consisting primarily of single packet messages in a datagram mode of operation. The motivation for the design of the protocols came from the consideration of efficient multiple access utilization of moderate to high bandwidth (4-40 Mbit/s capacity) communication satellite channels used for the transmission of short (1000-10,000 bits) fixed length packets. Under these circumstances, the ratio of roundtrip propagation time to packet transmission time is between 100 to 10,000. It is shown how a TDMA channel can be adaptively shared by datagram traffic and constant bandwidth users such as in digital voice applications. The distributed reservation control protocols described are a hybrid between contention and reservation protocols.

  20. Vaccine-preventable diseases: the role of the European Centre for Disease Prevention and Control.

    PubMed

    Kramarz, P; Lopalco, P L; Huitric, E; Pastore Celentano, L

    2014-05-01

    The role of the European Centre for Disease Prevention and Control (ECDC) is to strengthen the capacity of the European Union (EU) Member States to protect human health through the prevention and control of infectious diseases. The main objective of the programme on vaccine-preventable diseases and invasive bacterial infections (VPD) is to provide robust evidence and high-quality technical support to the EU Member States to help them in their efforts to prevent and control VPD. Since the establishment of ECDC, several existing VPD surveillance networks have been transferred to ECDC, namely EU-IBIS, DIPNET and EUVAC. In addition to surveillance of diseases, ECDC is collecting information and monitoring other parameters that are of crucial importance for a well-functioning immunization system, including vaccination coverage. The VPD programme also provides independent scientific opinions in the area of immunization and initiates and coordinates scientific studies in the area of vaccination to answer specific questions of public health importance, including risk perception and analysis of behaviour in different population groups. One of the overall ECDC priorities over recent years is the Centre's involvement in measles elimination. The 'Message' tool and the 'Measles Atlas' are examples of work aiming at supporting the efforts of Member States in the elimination phase.

  1. Commonality of flight control systems for support of European telecommunications missions

    NASA Technical Reports Server (NTRS)

    Debatin, Kurt

    1993-01-01

    This paper is concerned with the presentation of mission-independent software systems that provide a common software platform to ground data systems for mission operations. The objectives of such common software platforms are to reduce the cost of the development of mission-dedicated software systems and to increase the level of reliability of the ground data systems for mission operations. In accordance with this objective, the Multi-Satellite Support System (MSSS) was developed at the European Space Operations Center (ESOC). Between 1975 and 1992, the MSSS provided support to 16 European Space Agency (ESA) missions, among them very demanding science missions such as GEOS, EXOSAT, and Giotto. The successful support of these missions proved the validity of the MSSS concept with its extended mission-independent platform. This paper describes the MSSS concept and focuses on the wide use of MSSS as a flight control system for geosynchronous telecommunications satellites. Reference is made to more than 15 telecommunications missions that are operated from Western Europe using flight control systems with an underlying MSSS concept, demonstrating the benefits of a commonly used software platform. Finally, the paper outlines the design of the new generation of flight control systems, which is being developed at ESOC for this decade, following a period of more than 15 years of MSSS support.

  2. Randomized, Placebo-Controlled Trials in Alpha-1 Antitrypsin Deficiency.

    PubMed

    Sandhaus, Robert A

    2016-08-01

    Alpha-1 antitrypsin deficiency (AATD) is a condition caused by the inheritance of two mutated SERPINA1 gene alleles. Individuals with AATD are at increased risk of injury to the liver and lungs. The pulmonary manifestations include precocious onset of pulmonary emphysema and bronchiectasis. For nearly three decades, treatment has been available to individuals with emphysema caused by AATD, but this therapy-augmentation of plasma and tissue alpha-1 antitrypsin levels by intravenous administration of human plasma-derived protein-was approved by regulatory authorities based on its biochemical efficacy. This therapy appears to slow the progression of emphysema in patients with AATD. The medical, patient, and regulatory communities have sought assurance that this expensive therapy provides measurable clinical benefit. Documenting such benefit has been difficult because of the slow progression of the underlying lung disease in AATD, the rarity of this genetic condition, and the lack of direct quantitative measurements of emphysema progression. Over the past decade, quantitative computed tomography (CT) densitometry of the lungs has been found to correlate with severity and progression of emphysema. The recent publication of a well-powered, masked, placebo-controlled study using CT densitometry to evaluate the effectiveness of augmentation therapy at slowing the progression of emphysema has provided some assurance of the clinical efficacy of this therapy. PMID:27564674

  3. The quality of control groups in non-randomized studies published in Journal of Hand Surgery

    PubMed Central

    Johnson, Shepard P.; Malay, Sunitha; Chung, Kevin C.

    2016-01-01

    Purpose To evaluate control group selection in non-randomized studies published in the Journal of Hand Surgery American (JHS). Methods We reviewed all papers published in JHS in 2013 to identify studies that used non-randomized control groups. Data collected included type of study design and control group characteristics. We then appraised studies to determine if authors discussed confounding and selection bias and how they controlled for confounding. Results Thirty-seven non-randomized studies were published in JHS in 2013. The source of control was either the same institution as the study group, a different institution, a database, or not provided in the manuscript. Twenty-nine (78%) studies statistically compared key characteristics between control and study group. Confounding was controlled with matching, exclusion criteria, or regression analysis. Twenty-two (59%) papers explicitly discussed the threat of confounding and 18(49%) identified sources of selection bias. Conclusions In our review of non-randomized studies published in JHS, papers had well-defined controls that were similar to the study group, allowing for reasonable comparisons. However, we identified substantial confounding and bias that were not addressed as explicit limitations, which might lead the reader to overestimate the scientific validity of the data. Clinical relevance Incorporating a brief discussion of control group selection in scientific manuscripts should help readers interpret the study more appropriately. Authors, reviewers, and editors should strive to address this component of clinical importance. PMID:25447000

  4. One-step receding horizon H(∞) control for networked control systems with random delay and packet disordering.

    PubMed

    Liu, Andong; Yu, Li; Zhang, Wen-An

    2011-01-01

    The receding horizon H(∞) control (RHHC) problem is investigated in this paper for a class of networked control systems (NCSs) with random delay and packet disordering. A new model is proposed to describe the NCS with random delay which may be larger than one sampling period. The random delay is modeled as a Markov chain while the closed-loop system is described as a Markovian jump system. Sufficient conditions for the closed-loop NCS to be stochastically stable and the performance index to be upper bounded are derived by using the receding optimization principle. Furthermore, by solving a semi-definite programming (SDP) with linear matrix inequalities (LMIs) constraint, a piecewise-constant receding horizon H(∞) controller is obtained, and the designed piecewise-constant controller ensures that the closed-loop NCS achieves a prescribed H(∞) disturbance attenuation level. Finally, an illustrative example is given to demonstrate the effectiveness of the proposed method.

  5. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    ERIC Educational Resources Information Center

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

  6. A RANDOMIZED CONTROLLED TRIAL OF RESISTANCE EXERCISE TRAINING TO IMPROVE GLYCEMIC CONTROL IN OLDER ADULTS WITH TYPE 2 DIABETES

    Technology Transfer Automated Retrieval System (TEKTRAN)

    OBJECTIVE-To determine the efficacy of high-intensity progressive resistance training (PRT) on glycemic control in older adults with type 2 diabetes. RESEARCH DESIGN AND METHODS-We performed a 16-week randomized controlled trial in 62 Latino older adults (40 women and 22 men; mean +/- SE age 66 +/...

  7. INSTRUCTIONAL CONFERENCE ON THE THEORY OF STOCHASTIC PROCESSES: Controlled random sequences and Markov chains

    NASA Astrophysics Data System (ADS)

    Yushkevich, A. A.; Chitashvili, R. Ya

    1982-12-01

    CONTENTSIntroduction Chapter I. Foundations of the general theory of controlled random sequences and Markov chains with the expected reward criterion § 1. Controlled random sequences, Markov chains, and models § 2. Necessary and sufficient conditions for optimality § 3. The Bellman equation for the value function and the existence of (ε-) optimal strategies Chapter II. Some problems in the theory of controlled homogeneous Markov chains § 4. Description of the solutions of the Bellman equation, a characterization of the value function, and the Bellman operator § 5. Sufficiency of stationary strategies in homogeneous Markov models § 6. The lexicographic Bellman equation References

  8. Searching for control: priming randomness increases the evaluation of ritual efficacy.

    PubMed

    Legare, Cristine H; Souza, André L

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual action and a desired outcome. Two experiments were conducted (one in Brazil [n = 40] and another in the United States [n = 94]) to evaluate how the perceived efficacy of rituals is affected by feelings of randomness. In a between-subjects design, the Scramble Sentence Task was used as a priming procedure in three conditions (i.e., randomness, negativity, and neutral) and participants were then asked to rate the efficacy of rituals used for problem-solving purposes. The results demonstrate that priming randomness increased participants' perception of ritual efficacy relative to negativity and neutral conditions. Implications for increasing our understanding of the relationship between perceived control and ritualistic behavior are discussed.

  9. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

    PubMed Central

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

    2014-01-01

    Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

  10. Effectiveness of "Primary Bereavement Care" for Widows: A Cluster Randomized Controlled Trial Involving Family Physicians

    ERIC Educational Resources Information Center

    García, Jesus A.; Landa, Victor; Grandes, Gonzalo; Pombo, Haizea; Mauriz, Amaia

    2013-01-01

    Thirty-one family physicians, from 19 primary care teams in Biscay (Spain), were randomly assigned to intervention or control group. The 15 intervention family physicians, after training in primary bereavement care, saw 43 widows for 7 sessions, from the 4th to 13th month after their loss. The 16 control family physicians, without primary…

  11. A Compound Herbal Preparation (CHP) in the Treatment of Children with ADHD: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Katz, M.; Adar Levine, A.; Kol-Degani, H.; Kav-Venaki, L.

    2010-01-01

    Objective: Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. Method: Design: A randomized, double-blind, placebo-controlled trial. Setting: University-affiliated tertiary medical center. Participants: 120 children newly diagnosed with ADHD,…

  12. A Randomized Controlled Trial of Hanen's "More than Words" in Toddlers with Early Autism Symptoms

    ERIC Educational Resources Information Center

    Carter, Alice S.; Messinger, Daniel S.; Stone, Wendy L.; Celimli, Seniz; Nahmias, Allison S.; Yoder, Paul

    2011-01-01

    Background: This randomized controlled trial compared Hanen's "More than Words" (HMTW), a parent-implemented intervention, to a "business as usual" control group. Methods: Sixty-two children (51 boys and 11 girls; M age = 20 months; SD = 2.6) who met criteria for autism spectrum disorders (ASD) and their parents participated in the study. The HMTW…

  13. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    ERIC Educational Resources Information Center

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  14. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    ERIC Educational Resources Information Center

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  15. Strength and Agility Training in Adolescents with Down Syndrome: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lin, Hsiu-Ching; Wuang, Yee-Pay

    2012-01-01

    The purpose of this study was to investigate the effects of a proposed strength and agility training program of adolescents with Down syndrome. Ninety-two adolescents were recruited and evenly randomized to two intervention groups (exercise group vs. control group). The mean age for the exercise and the control group was 10.6 plus or minus 3.2 and…

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

  17. Concern about passive smoking and tobacco control policies in European countries: An ecological study

    PubMed Central

    2012-01-01

    Background Because of the magnitude of the global tobacco epidemic, the World Health Organisation developed the Framework Convention on Tobacco Control (FCTC), an international legally binding treaty to control tobacco use. Adoption and implementation of specific tobacco control measures within FCTC is an outcome of a political process, where social norms and public opinion play important roles. The objective of our study was to examine how a country’s level of tobacco control is associated with smoking prevalence, two markers of denormalisation of smoking (social disapproval of smoking and concern about passive smoking), and societal support for tobacco control. Methods An ecological study was conducted, using data from two sources. The first source was the Tobacco Control Scale (TCS) from 2011, which quantifies the implementation of tobacco control policies in European Union (EU) countries. Data on smoking prevalence, societal disapproval of smoking, concern about passive smoking, and societal support for policy measures were taken from the Eurobarometer survey of 2009. Data from Eurobarometer surveys were aggregated to country level. Data from the 27 European Union member states were used. Results Smoking prevalence rates in 2009 were negatively associated with a country’s TCS 2011 score, although not statistically significant (r = −.25; p = .21). Experience of societal disapproval was positively associated with higher TCS scores, though not significantly (r = .14; p = .48). The same was true for societal support for tobacco control (r = .27; p = .18). The TCS score in 2011 was significantly correlated with concern about passive smoking (r = .42; p =.03). Support for tobacco control measures was also strongly correlated with concern about passive smoking (r = .52, p = .006). Conclusions Smokers in countries with a higher TCS score were more concerned about whether their smoke harms others. Further, support for tobacco control measures is higher in

  18. Citalopram controls phobic symptoms in patients with panic disorder: randomized controlled trial.

    PubMed Central

    Leinonen, E; Lepola, U; Koponen, H; Turtonen, J; Wade, A; Lehto, H

    2000-01-01

    OBJECTIVE: To examine the effects of long-term treatment with citalopram or clomipramine on subjective phobic symptoms in patients with panic disorder. DESIGN: Double-blind, parallel-group, five-arm study. PATIENTS: Patients aged 18 to 65 years with panic disorder (DMS-III-R diagnosis) and with no major depressive symptoms. INTERVENTIONS: Four hundred and seventy-five patients were randomized to 8 weeks of treatment with either citalopram (10 to 15 mg per day; 20 to 30 mg per day; or 40 to 60 mg per day), clomipramine (60 to 90 mg per day) or placebo. Two hundred and seventy-nine patients continued treatment after the 8-week acute phase. OUTCOME MEASURES: Phobic symptoms were assessed using the Phobia Scale and the Symptom Checklist's (SCL-90) phobia-related factors. RESULTS: At all dosages, citalopram was more efficacious than placebo, with 20 to 30 mg generally being the most effective dosage. Citalopram (20 to 30 mg) generally decreased phobic symptoms significantly more than placebo after Month 3. Interpersonal sensitivity decreased when measured on the respective SCL-90 sub-scale. Alleviation of phobic symptoms generally continued to increase towards the end of the treatment. The effect of clomipramine was not as consistent. CONCLUSIONS: All active treatment groups, especially the group receiving 20 to 30 mg per day of citalopram, effectively controlled phobic symptoms in patients with panic disorder. Long-term treatment with citalopram further decreased phobic symptoms. PMID:10721681

  19. Efficacy of Control Measures for European Buckthorn ( Rhamnus cathartica L.) in Saskatchewan

    NASA Astrophysics Data System (ADS)

    Delanoy, Luc; Archibold, O. W.

    2007-10-01

    Introduced to Saskatchewan in the 1930s as a potential shelterbelt species, European buckthorn is now a prominent understory shrub in riparian woodland and shrub communities around Saskatoon. Locally, the Meewasin Valley Authority (MVA) is actively controlling buckthorn as part of its mandate to conserve natural heritage resources of the South Saskatchewan River Valley, with the goal of restoring the natural biodiversity of remnant patches of native vegetation. European buckthorn is normally dioecious, and MVA has chosen to treat only fruiting stems in an attempt to limit seed production. Two control techniques have been used. In one treatment, glyphosate was applied to stems after cutting; alternatively Garlon 4 Dow AgroSciences herbicide (active ingredient triclopyr) was applied as a chemical girdle directly to the stems using a streamline basal bark spray method. To date, more than 347,000 fruiting stems of buckthorn have been treated. Results indicate good initial progress in limiting seed production in dense buckthorn sites, but at a high cost. Although seed eradication is not a practical short-term goal for the Saskatoon buckthorn population, chemical girdling can substantially and strategically reduce seed and effectively limit spread. Field-tested strategies to reduce costs and improve efficiencies are discussed.

  20. Terrestrial rabies control in the European Union: historical achievements and challenges ahead.

    PubMed

    Müller, Thomas; Freuling, Conrad Martin; Wysocki, Patrick; Roumiantzeff, Micha; Freney, Jean; Mettenleiter, Thomas Christoph; Vos, Adriaan

    2015-01-01

    Due to the implementation of oral rabies vaccination (ORV) programmes, the European Union (EU) is becoming progressively free of red fox (Vulpes vulpes)-mediated rabies. Over the past three decades, the incidence of rabies had decreased substantially and vast areas of Western and Central Europe have been freed from rabies using this method of controlling an infectious disease in wildlife. Since rabies control is a top priority in the EU, the disease is expected to be eliminated from the animal source in the near future. While responsible authorities may consider the mission of eliminating fox rabies from the EU almost accomplished, there are still issues to be dealt with and challenges to be met that have not yet been in the focus of attention, but could jeopardise the ultimate goal. Among them are increasing illegal movements of animals, maintaining funding support for vaccination campaigns, devising alternative vaccine strategies in neighbouring Eastern European countries and the expanding distribution range of several potential rabies reservoir species in Europe.

  1. Treatment Effectiveness of PMTO for Children's Behavior Problems in Iceland: Child Outcomes in a Nationwide Randomized Controlled Trial.

    PubMed

    Sigmarsdóttir, Margrét; Thorlacius, Örnólfur; Guðmundsdóttir, Edda Vikar; DeGarmo, David S

    2015-09-01

    Well-documented treatment methods must be tested following their implementation in community service agencies and across different cultures to ensure continuing effectiveness. This study was a randomized controlled trial (RCT) of Parent Management Training-the Oregon model (PMTO), conducted within a nationwide implementation in Iceland. Families of 102 clinically referred children with behavior problems were recruited from five municipalities throughout Iceland. Child age ranged from 5 to 12; 73% were boys. Families were randomly assigned to either PMTO or services usually offered in the communities (SAU). Child adjustment was measured with a latent construct based on parent, child, and teacher reports of externalizing and internalizing problems and social skills. Prepost intent-to-treat analyses showed that PMTO treatment led to greater reductions in child adjustment problems relative to the comparison group, obtaining a modest to medium effect size based on the construct score. Only one indicator (parent-rated Social Skills) showed significant change independently and information on amount and kind of treatment in the SAU was limited. Overall, findings indicate that PMTO is an effective method to treat children's behavior problems in a Northern European culture and supply evidence for the method's successful implementation in community settings in Iceland. This is one of few nationwide implementation studies of PMTO outside the United States and the first RCT in Iceland to test a treatment model for children's behavior problems. PMID:25410965

  2. Treatment Effectiveness of PMTO for Children's Behavior Problems in Iceland: Child Outcomes in a Nationwide Randomized Controlled Trial.

    PubMed

    Sigmarsdóttir, Margrét; Thorlacius, Örnólfur; Guðmundsdóttir, Edda Vikar; DeGarmo, David S

    2015-09-01

    Well-documented treatment methods must be tested following their implementation in community service agencies and across different cultures to ensure continuing effectiveness. This study was a randomized controlled trial (RCT) of Parent Management Training-the Oregon model (PMTO), conducted within a nationwide implementation in Iceland. Families of 102 clinically referred children with behavior problems were recruited from five municipalities throughout Iceland. Child age ranged from 5 to 12; 73% were boys. Families were randomly assigned to either PMTO or services usually offered in the communities (SAU). Child adjustment was measured with a latent construct based on parent, child, and teacher reports of externalizing and internalizing problems and social skills. Prepost intent-to-treat analyses showed that PMTO treatment led to greater reductions in child adjustment problems relative to the comparison group, obtaining a modest to medium effect size based on the construct score. Only one indicator (parent-rated Social Skills) showed significant change independently and information on amount and kind of treatment in the SAU was limited. Overall, findings indicate that PMTO is an effective method to treat children's behavior problems in a Northern European culture and supply evidence for the method's successful implementation in community settings in Iceland. This is one of few nationwide implementation studies of PMTO outside the United States and the first RCT in Iceland to test a treatment model for children's behavior problems.

  3. The serotonin transporter 5-HTTLPR polymorphism and treatment response to nicotine patch: follow-up of a randomized controlled trial.

    PubMed

    David, Sean P; Munafò, Marcus R; Murphy, Michael F G; Walton, Robert T; Johnstone, Elaine C

    2007-02-01

    In this follow-up of a randomized placebo-controlled clinical trial of nicotine replacement transdermal patch for smoking cessation, 741 smokers of European ancestry who were randomized to receive active patch or placebo patch were genotyped for the serotonin transporter gene-linked polymorphic region. The study setting was a primary care research network in Oxfordshire, United Kingdom. The primary outcome measures were biochemically verified sustained abstinence from cigarette smoking at end of treatment and 24-week follow-up. The main effect of genotype was not associated with sustained abstinence from smoking at either end of treatment (SL: p=.33; SS: p=.81) or 24-week follow-up (SL: p=.05; SS: p=.21), and we found no evidence for a genotypextreatment interaction effect. In summary, despite the theoretically important contribution of serotonin neurotransmission to smoking cessation, the serotonin transporter gene was not associated with treatment response to nicotine patch for smoking cessation in this primary care-based trial.

  4. Evaluation of the PPAR-γ Agonist Pioglitazone in Mild Asthma: A Double-Blind Randomized Controlled Trial

    PubMed Central

    Anderson, J. R.; Pang, L.; Smith, K. M; Bailey, H.; Hodgson, D. B.; Shaw, D. E.; Knox, A. J.; Harrison, T. W.

    2016-01-01

    Background Peroxisome proliferator-activated receptor gamma (PPAR-γ) is a nuclear receptor that modulates inflammation in models of asthma. To determine whether pioglitazone improves measures of asthma control and airway inflammation, we performed a single-center randomized, double-blind, placebo-controlled, parallel-group trial. Methods Sixty-eight participants with mild asthma were randomized to 12 weeks pioglitazone (30 mg for 4 weeks, then 45 mg for 8 weeks) or placebo. The primary outcome was the adjusted mean forced expiratory volume in one second (FEV1) at 12 weeks. The secondary outcomes were mean peak expiratory flow (PEF), scores on the Juniper Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ), fractional exhaled nitric oxide (FeNO), bronchial hyperresponsiveness (PD20), induced sputum counts, and sputum supernatant interferon gamma-inducible protein-10 (IP-10), vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), and eosinophil cationic protein (ECP) levels. Study recruitment was closed early after considering the European Medicines Agency’s reports of a potential increased risk of bladder cancer with pioglitazone treatment. Fifty-five cases were included in the full analysis (FA) and 52 in the per-protocol (PP) analysis. Results There was no difference in the adjusted FEV1 at 12 weeks (-0.014 L, 95% confidence interval [CI] -0.15 to 0.12, p = 0.84) or in any of the secondary outcomes in the FA. The PP analysis replicated the FA, with the exception of a lower evening PEF in the pioglitazone group (-21 L/min, 95% CI -39 to -4, p = 0.02). Conclusions We found no evidence that treatment with 12 weeks of pioglitazone improved asthma control or airway inflammation in mild asthma. Trial Registration ClinicalTrials.gov NCT01134835 PMID:27560168

  5. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial

    PubMed Central

    Ngo, Lynn L.; Ward, Kristy K.; Mody, Sheila K.

    2015-01-01

    Objective To evaluate intramuscular ketorolac compared to placebo saline injection for pain control with intrauterine device (IUD) placement. Methods We conducted a randomized, double-blind, placebo controlled trial between July 2012 and March 2014. Patients received ketorolac 30mg or placebo saline intramuscular injection 30 minutes prior to IUD placement. The primary outcome was pain with IUD placement on a 10cm visual analog scale (VAS). Sample size was calculated to provide 80% power to show a 2.0cm difference (α=0.05) in the primary outcome. Secondary outcomes included pain with study drug injection, speculum insertion, tenaculum placement, uterine sounding, and at 5 and 15 minutes after IUD placement. Results A total of 67 women participated in the study, 33 in the ketorolac arm and 34 in the placebo arm. There were no differences in baseline demographics including age, BMI, and race. There were no differences in median pain scores for IUD placement in the placebo versus ketorolac groups (5.2cm vs 3.6cm, p=0.99). There was a decrease in median pain scores at 5 minutes (2.2cm vs 0.3cm, p=<0.001) and 15 minutes (1.6cm vs 0.1cm, p=<0.001) after IUD placement but no difference for all other time points. Nulliparous participants (n=16, 8 per arm) had a decrease in pain scores with IUD placement (8.1cm vs 5.4cm, p=0.02). In this study, 22% of participants in the placebo group and 18% in the ketorolac group reported injection pain was as painful as IUD placement. Conclusions Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement. PMID:26241253

  6. Effect of Probiotics on Glycemic Control: A Systematic Review and Meta-Analysis of Randomized, Controlled Trials

    PubMed Central

    He, Jie; Chen, Fangyao; Chen, Rongping; Chen, Hong

    2015-01-01

    Background Previous clinical trials indicate that probiotic consumption may improve blood glucose control, however, results from randomized trials on glycemic control have been inconsistent. Objective To investigate the effects of probiotics on glycemic control in a systematic review and meta-analysis of randomized controlled trials. Data Sources PubMed, Embase, Cochrane Library, and Clinicaltrial.gov through October 2014. Data Extraction and Synthesis Two independent reviewers extracted relevant data and assessed study quality and risk of bias. Data were pooled using a random-effects model and expressed as mean differences (MD) with 95% CI. Heterogeneity was assessed (Cochran Q-statistic) and quantified (I2). Results Seventeen randomized controlled trials were included, in which 17 fasting blood glucose (n = 1105), 11 fasting plasma insulin (n = 788), 8 homeostasis model assessment of insulin resistance (n = 635) comparisons were reported. Probiotic consumption, compared with placebo, significantly reduced fasting glucose (MD = -0.31 mmol/L; 95% CI 0.56, 0.06; p = 0.02), fasting plasma insulin (MD = -1.29 μU/mL; 95% CI -2.17, -0.41; p = 0.004), and HOMA-IR (MD = 0.48; 95% CI -0.83, -0.13; p = 0.007). Conclusions Probiotic consumption may improve glycemic control modestly. Modification of gut microbiota by probiotic supplementation may be a method for preventing and control hyperglycemia in clinical practice. PMID:26161741

  7. Geogenic and agricultural controls on the geochemical composition of European agricultural soils

    NASA Astrophysics Data System (ADS)

    Mol, Gerben; Saaltink, Remon; Griffioen, Jasper; Birke, Manfred

    2014-05-01

    Purpose: Concern about the environmental impact of agriculture caused by intensification is growing as large amounts of nutrients and contaminants are introduced into the environment. The aim of this paper is to identify the geogenic and agricultural controls on the elemental composition of European, grazing and agricultural soils. Materials and methods: Robust factor analysis was applied to data series for Al,B,Ca, Cd,Co, Cu, Fe, K, Mg,Mn, Na,Ni, P, S, Se, Sr, U, Zn (ICP-MS) and SiO2, K2O, Na2O, Fe2O3, Al2O3 (XRF) based on the European GEMAS dataset. In addition, the following general soil properties were included: clay content, pH, chemical index of alteration (CIA), loss on ignition (LOI), cation exchange capacity (CEC), total organic carbon (TOC) and total carbon and total sulfur. Furthermore, this dataset was coupled to a dataset containing information of historic P2O5 fertilization across Europe. Also, a mass balance was carried out for Cd, Cu and Zn to determine if concentrations of these elements found in the soils have their origin in historic P2O5 fertilization. Results and discussion: Seven geogenic factors and one agricultural factor were found of which four prominent ones (all geogenic): chemical weathering, reactive iron-aluminum oxide minerals, clay minerals and carbonate minerals. Results for grazing and agricultural soils were near identical, which further proofs the prominence of geogenic controls on the total elemental composition. When the cumulative amount of P2O5 fertilization was considered, no extra agriculture-related factors became visible. The mass balance confirms these observations. Conclusion: Overall, the geological controls are more important for the total soil chemistry in agricultural and grazing land soils than the anthropogenic controls.

  8. Analysis of random drop for gateway congestion control. M.S. Thesis

    NASA Technical Reports Server (NTRS)

    Hashem, Emam Salaheddin

    1989-01-01

    Lately, the growing demand on the Internet has prompted the need for more effective congestion control policies. Currently No Gateway Policy is used to relieve and signal congestion, which leads to unfair service to the individual users and a degradation of overall network performance. Network simulation was used to illustrate the character of Internet congestion and its causes. A newly proposed gateway congestion control policy, called Random Drop, was considered as a promising solution to the pressing problem. Random Drop relieves resource congestion upon buffer overflow by choosing a random packet from the service queue to be dropped. The random choice should result in a drop distribution proportional to the bandwidth distribution among all contending TCP connections, thus applying the necessary fairness. Nonetheless, the simulation experiments demonstrate several shortcomings with this policy. Because Random Drop is a congestion control policy, which is not applied until congestion has already occurred, it usually results in a high drop rate that hurts too many connections including well-behaved ones. Even though the number of packets dropped is different from one connection to another depending on the buffer utilization upon overflow, the TCP recovery overhead is high enough to neutralize these differences, causing unfair congestion penalties. Besides, the drop distribution itself is an inaccurate representation of the average bandwidth distribution, missing much important information about the bandwidth utilization between buffer overflow events. A modification of Random Drop to do congestion avoidance by applying the policy early was also proposed. Early Random Drop has the advantage of avoiding the high drop rate of buffer overflow. The early application of the policy removes the pressure of congestion relief and allows more accurate signaling of congestion. To be used effectively, algorithms for the dynamic adjustment of the parameters of Early Random Drop

  9. Long range geoid control through the European GPS traverse: Final results

    NASA Technical Reports Server (NTRS)

    Torge, W.; Basic, T.; Denker, H.; Doliff, J.; Wenzel, H.-G.

    1989-01-01

    The European north-south Global Positioning System (GPS)-traverse proposed by IAG SSG 3.88, should control and improve the European geoid. This traverse follows first order leveling lines, included in the United European Leveling Network. From May to August 1986 and in July 1987, the central and northern part of this traverse (approx. 3000 km) was observed using up to four TI 4100 receivers, covering Austria, Federal Republic of Germany, Denmark, Sweden and Norway. Both traverse parts contain 71 stations with distances of about 50 km. In addition, 8 stations have been occupied for overlapping connections, and traverse links were established for connecting the fundamental stations Wettzell (VLBI and SLR) and Onsala (VLBI). Final results show a GPS observation precision of a few cm for loops of some 100 km circumference. After transformation of the GPS results to geoid heights using the leveled heights, comparisons with different existing gravimetric geoid determinations including geopotential models were performed. In addition, new geopotential models complete to degree and order 360 tailored to gravity data in Europe, and gravimetric geoid solutions using 6 x 10' mean gravity anomalies were investigated. The comparison with GPS and leveling yields rms discrepancies of + or - 0.1...0.2 m over 1000 km traverse sections for the best solutions, but a strong slope is existing in Sweden and southern Norway in almost all solutions, which is probably caused by systematic errors in the available gravity data for Scandinavia. This is confirmed by a new geoid computation at the Danish Geodetic Institute where the slope has disappeared. If this new solution is taken for the northern traverse section and the best solution for the central part, the rms discrepancy reduces to approximately + or - 0.2 m over 3000 km. Thus, a + or - 10 (exp 7) relative height accuracy seems to be achievable over long distances with the GPS/leveling and the gravimetric geoid calculation techniques

  10. Observer-based H(infinity) control for networked nonlinear systems with random packet losses.

    PubMed

    Li, Jian Guo; Yuan, Jing Qi; Lu, Jun Guo

    2010-01-01

    This paper investigates the observer-based H(infinity) control problem of networked nonlinear systems with global Lipschitz nonlinearities and random communication packet losses. The random packet loss is modelled as a Bernoulli distributed white sequence with a known conditional probability distribution. In the presence of random packet losses, sufficient conditions for the existence of an observer-based feedback controller are derived, such that the closed-loop networked nonlinear system is exponentially stable in the mean-square sense, and a prescribed H(infinity) disturbance-rejection-attenuation performance is also achieved. Then a linear matrix inequality (LMI) approach for designing such an observer-based H(infinity) controller is presented. Finally, a simulation example is used to demonstrate the effectiveness of the proposed method.

  11. Promoting Healthy Beginnings: A Randomized Controlled Trial of a Preventive Intervention to Preserve Marital Quality During the Transition to Parenthood

    ERIC Educational Resources Information Center

    Schulz, Marc S.; Cowan, Carolyn Pape; Cowan, Philip A.

    2006-01-01

    Couples expecting their first child were randomly assigned to intervention (n = 28) and comparison groups (n = 38) to assess the efficacy of a couples intervention and examine marital satisfaction trajectories across the transition to parenthood. The primarily European American sample (M age = 30 years) completed assessments of marital…

  12. Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial

    PubMed Central

    Stessel, Björn; Theunissen, Maurice; Fiddelers, Audrey A.; Joosten, Elbert A.; Kessels, Alfons G.; Gramke, Hans-Fritz; Marcus, Marco A.

    2014-01-01

    Background Strong opioids in the home setting after ambulatory surgery have rarely been studied for fear of hazardous adverse effects such as respiratory depression. Objectives We compared the efficacy of paracetamol/controlled-release (CR) oxycodone and paracetamol/naproxen for treatment of acute postoperative pain at home after ambulatory surgery. Secondary outcomes were adverse effects of study medication, treatment satisfaction, and postoperative analgesic compliance. Methods Patients undergoing ambulatory knee arthroscopy or inguinal hernia repair surgery (n = 105) were randomized into 3 groups: Group1 paracetamol/naproxen (n = 35), Group 2 paracetamol/CR oxycodone for 24 hours (n = 35), and Group 3 paracetamol/CR oxycodone for 48 hours (n = 35). Pain intensity at movement and at rest using a visual analog scale as well as satisfaction with postoperative analgesia and side effects were recorded for up to 48 hours postoperatively. Compliance with study medication was also assessed. Results For pain at movement and at rest, no significant differences were found between the paracetamol/naproxen group and either the paracetamol/CR oxycodone for 24 hours group (β = 2.6 [4.9]; P = 0.597) or the paracetamol/CR oxycodone for 48 hours (β = –1.7 [5.1]; P = 0.736). No major adverse effects of study medication were registered and satisfaction with postoperative pain treatment was high in all groups. Compliance was comparable across the groups. Despite clear instructions, 8 patients with the lowest pain scores did not use any of the prescribed pain medication. Conclusions Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs

  13. Digital servo control of random sound test excitation. [in reverberant acoustic chamber

    NASA Technical Reports Server (NTRS)

    Nakich, R. B. (Inventor)

    1974-01-01

    A digital servocontrol system for random noise excitation of a test object in a reverberant acoustic chamber employs a plurality of sensors spaced in the sound field to produce signals in separate channels which are decorrelated and averaged. The average signal is divided into a plurality of adjacent frequency bands cyclically sampled by a time division multiplex system, converted into digital form, and compared to a predetermined spectrum value stored in digital form. The results of the comparisons are used to control a time-shared up-down counter to develop gain control signals for the respective frequency bands in the spectrum of random sound energy picked up by the microphones.

  14. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

    PubMed Central

    Tan, Jing-Yu; Suen, Lorna K. P.; Wang, Tao; Molassiotis, Alexander

    2015-01-01

    Objectives To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. Methods Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes. Results Sixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and “non-acupoint” stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes. Conclusions A great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes

  15. The Impact of Parental Support, Behavioral Control, and Psychological Control on the Academic Achievement and Self-Esteem of African American and European American Adolescents.

    ERIC Educational Resources Information Center

    Bean, Roy A.; Bush, Kevin R.; McKenry, Patrick C.; Wilson, Stephan M.

    2003-01-01

    Relationships between adolescent functioning and parent support, behavioral control, and psychological control were examined among European American and African American adolescents. A number of correlations were significant, including maternal support and academic achievement and self-esteem, and paternal psychological control and self-esteem.…

  16. Electrically controllable liquid crystal random lasers below the Fréedericksz transition threshold.

    PubMed

    Lee, Chia-Rong; Lin, Jia-De; Huang, Bo-Yuang; Lin, Shih-Hung; Mo, Ting-Shan; Huang, Shuan-Yu; Kuo, Chie-Tong; Yeh, Hui-Chen

    2011-01-31

    This investigation elucidates for the first time electrically controllable random lasers below the threshold voltage in dye-doped liquid crystal (DDLC) cells with and without adding an azo-dye. Experimental results show that the lasing intensities and the energy thresholds of the random lasers can be decreased and increased, respectively, by increasing the applied voltage below the Fréedericksz transition threshold. The below-threshold-electric-controllability of the random lasers is attributable to the effective decrease of the spatial fluctuation of the orientational order and thus of the dielectric tensor of LCs by increasing the electric-field-aligned order of LCs below the threshold, thereby increasing the diffusion constant and decreasing the scattering strength of the fluorescence photons in their recurrent multiple scattering. This can result in the decrease in the lasing intensity of the random lasers and the increase in their energy thresholds. Furthermore, the addition of an azo-dye in DDLC cell can induce the range of the working voltage below the threshold for the control of the random laser to reduce.

  17. Early non-invasive cardiac output monitoring in hemodynamically unstable intensive care patients: A multi-center randomized controlled trial

    PubMed Central

    2011-01-01

    Introduction Acute hemodynamic instability increases morbidity and mortality. We investigated whether early non-invasive cardiac output monitoring enhances hemodynamic stabilization and improves outcome. Methods A multicenter, randomized controlled trial was conducted in three European university hospital intensive care units in 2006 and 2007. A total of 388 hemodynamically unstable patients identified during their first six hours in the intensive care unit (ICU) were randomized to receive either non-invasive cardiac output monitoring for 24 hrs (minimally invasive cardiac output/MICO group; n = 201) or usual care (control group; n = 187). The main outcome measure was the proportion of patients achieving hemodynamic stability within six hours of starting the study. Results The number of hemodynamic instability criteria at baseline (MICO group mean 2.0 (SD 1.0), control group 1.8 (1.0); P = .06) and severity of illness (SAPS II score; MICO group 48 (18), control group 48 (15); P = .86)) were similar. At 6 hrs, 45 patients (22%) in the MICO group and 52 patients (28%) in the control group were hemodynamically stable (mean difference 5%; 95% confidence interval of the difference -3 to 14%; P = .24). Hemodynamic support with fluids and vasoactive drugs, and pulmonary artery catheter use (MICO group: 19%, control group: 26%; P = .11) were similar in the two groups. The median length of ICU stay was 2.0 (interquartile range 1.2 to 4.6) days in the MICO group and 2.5 (1.1 to 5.0) days in the control group (P = .38). The hospital mortality was 26% in the MICO group and 21% in the control group (P = .34). Conclusions Minimally-invasive cardiac output monitoring added to usual care does not facilitate early hemodynamic stabilization in the ICU, nor does it alter the hemodynamic support or outcome. Our results emphasize the need to evaluate technologies used to measure stroke volume and cardiac output--especially their impact on the process of care--before any large

  18. Controlling of CSFV in European wild boar using oral vaccination: a review

    PubMed Central

    Rossi, Sophie; Staubach, Christoph; Blome, Sandra; Guberti, Vittorio; Thulke, Hans-Hermann; Vos, Ad; Koenen, Frank; Le Potier, Marie-Frédérique

    2015-01-01

    Classical swine fever (CSF) is among the most detrimental diseases for the swine industry worldwide. Infected wild boar populations can play a crucial role in CSF epidemiology and controlling wild reservoirs is of utmost importance for preventing domestic outbreaks. Oral mass vaccination (OMV) has been implemented to control CSF in wild boars and limit the spill over to domestic pigs. This retrospective overview of vaccination experiences illustrates the potential for that option. The C-strain live vaccine was confirmed to be highly efficacious and palatable baits were developed for oral delivery in free ranging wild boars. The first field trials were performed in Germany in the 1990’s and allowed deploying oral baits at a large scale. The delivery process was further improved during the 2000’s among different European countries. Optimal deployment has to be early regarding disease emergence and correctly designed regarding the landscape structure and the natural food sources that can compete with oral baits. OMV deployment is also highly dependent on a local veterinary support working closely with hunters, wildlife and forestry agencies. Vaccination has been the most efficient strategy for CSF control in free ranging wild boar when vaccination is wide spread and lasting for a sufficient period of time. Alternative disease control strategies such as intensified hunting or creating physical boundaries such as fences have been, in contrast, seldom satisfactory and reliable. However, monitoring outbreaks has been challenging during and after vaccination deployment since OMV results in a low probability to detect virus-positive animals and the live-vaccine currently available does not allow serological differentiation of infected from vaccinated animals. The development of a new marker vaccine and companion test is thus a promising option for better monitoring outbreaks during OMV deployment as well as help to better determine when to stop vaccination efforts

  19. Controlling of CSFV in European wild boar using oral vaccination: a review.

    PubMed

    Rossi, Sophie; Staubach, Christoph; Blome, Sandra; Guberti, Vittorio; Thulke, Hans-Hermann; Vos, Ad; Koenen, Frank; Le Potier, Marie-Frédérique

    2015-01-01

    Classical swine fever (CSF) is among the most detrimental diseases for the swine industry worldwide. Infected wild boar populations can play a crucial role in CSF epidemiology and controlling wild reservoirs is of utmost importance for preventing domestic outbreaks. Oral mass vaccination (OMV) has been implemented to control CSF in wild boars and limit the spill over to domestic pigs. This retrospective overview of vaccination experiences illustrates the potential for that option. The C-strain live vaccine was confirmed to be highly efficacious and palatable baits were developed for oral delivery in free ranging wild boars. The first field trials were performed in Germany in the 1990's and allowed deploying oral baits at a large scale. The delivery process was further improved during the 2000's among different European countries. Optimal deployment has to be early regarding disease emergence and correctly designed regarding the landscape structure and the natural food sources that can compete with oral baits. OMV deployment is also highly dependent on a local veterinary support working closely with hunters, wildlife and forestry agencies. Vaccination has been the most efficient strategy for CSF control in free ranging wild boar when vaccination is wide spread and lasting for a sufficient period of time. Alternative disease control strategies such as intensified hunting or creating physical boundaries such as fences have been, in contrast, seldom satisfactory and reliable. However, monitoring outbreaks has been challenging during and after vaccination deployment since OMV results in a low probability to detect virus-positive animals and the live-vaccine currently available does not allow serological differentiation of infected from vaccinated animals. The development of a new marker vaccine and companion test is thus a promising option for better monitoring outbreaks during OMV deployment as well as help to better determine when to stop vaccination efforts. After

  20. Privacy aware access controls for medical data disclosure on European healthgrids.

    PubMed

    Rahmouni, Hanene Boussi; Solomonides, Tony; Mont, Marco Casassa; Shiu, Simon

    2010-01-01

    To be processed within a healthgrid environment, medical data goes through a complete lifecycle and several stages until it is finally used for the primary reason it has been collected for. This stage is not always the final occurrence of when the data would have been manipulated. The data could rather continue to be needed for secondary purposes of legitimate or non legitimate nature. Although other privacy issues are related to the processing of patient data while it is residing on a healthgrid environment, the control of data disclosure is our primary interest. When sharing medical data between different Healthcare and biomedical research organizations in Europe, it is important that the different parties involved in the sharing handle the data in the same way indicated by the legislation of the member state where the data was originally collected as the requirements might differ from one state to another. Privacy requirements, such as patient consent, may be subject to conflicting conditions between different national frameworks as well as between different legal and ethical frameworks within a single member state. These circumstances have made the compliance management process in European healthgrid very challenging. In this paper we are presenting an approach to tackle these issues by relying on several technologies contained in the semantic web stack. Our work suggests a direct mapping from high level legislation on privacy and data protection to operational level privacy aware controls. Additionally we suggest an architecture for the enforcement of these controls on access control models adopted by healthgrids security infrastructures.

  1. Guidelines of the Commission of the European Communities: a challenge for the control of packaging.

    PubMed

    Feigenbaum, A E; Bouquant, J; Ducruet, V J; Ehret-Henry, J; Marqué, D L; Riquet, A M; Scholler, D; Wittmann, J C

    1994-01-01

    Questions arising from the Commission of the European Communities Directives and guidelines regulating packaging materials are discussed in relation to whether compliance ensures safety in use and the consequent analytical problems. Difficulties may arise from interactions between food contact materials and food involving mass transfer (migration, off-odours, 'scalping', loss of aroma) or mass transfer and chemical interactions and the implications for safety assurance and regulation are addressed. The criteria for suitable low molecular weight fatty food simulants and conditions for migration testing are presented. In food surveillance, the usefulness of various methods of analysis differs for monomers and for additives. For monomers, IR spectroscopy can identify the polymer type and which specific monomers need controlling; for unknown mixtures of additives, preliminary functional group identification by techniques such as 1H-NMR is useful. PMID:8039575

  2. Implementation and Operational Research: Computer-Assisted Intervention for Safer Sex in HIV-Positive Men Having Sex With Men: Findings of a European Randomized Multi-Center Trial

    PubMed Central

    Platteau, Tom; Bogner, Johannes; Buyze, Jozefien; Dec-Pietrowska, Joanna; Dias, Sonia; Newbury-Helps, John; Kocsis, Agnes; Mueller, Matthias; Rojas, Daniela; Stanekova, Danica; van Lankveld, Jacques; Colebunders, Robert

    2016-01-01

    Objective: Men who have sex with men (MSM) are the key population most affected by HIV in Europe. We performed the first European multicenter, simple-randomized parallel-group study to test the effectiveness of a theory-guided computer-assisted intervention to improve safer sex among HIV-positive men who have sex with men. Methods: Between February, 2011 and February, 2013, 112 participants were enrolled in 8 different European HIV-care settings. Intervention participants received 3 individual counseling sessions facilitated by trained service providers using computer-assisted tools. The control-group received sexual health advice delivered as part of regular HIV care. Outcome behavior (self-reported condom use at last intercourse; combined HIV transmission risk score), its influencing factors, and mediating variables were assessed at baseline, and at 3 and 6 months follow-up. Mixed effects models were used to compare primary outcomes (condom use at last intercourse, HIV transmission risk score), and mediation analysis to explore intervention effects. Results: Condom use at last intercourse increased more among intervention than control participants at 3 months follow-up (odds ratio of 3.83; P = 0.03), but not significantly at 6 months follow-up. Intervention participants reported a lower transmission risk at 3 months follow-up than controls (odds ratio compared with baseline of 11.53 and 1.28, respectively; P = 0.008), but this effect became nonsignificant at 6 months. Intervention effects were mediated by the proximal variables, self-efficacy to negotiate condom use and condom attitudes. Conclusions: This intervention showed short-term effectiveness. The intervention should be replicated in other settings, eventually investigating if booster-counseling sessions would yield a longer lasting effect. PMID:26866955

  3. European Expert Consensus Paper on the implementation of Article 14 of the WHO Framework Convention on Tobacco Control.

    PubMed

    Clancy, Luke

    2016-11-01

    On 24 November 2015, under the auspices of the European Policy Roundtable on Smoking Cessation, 15 experts on tobacco control and dependence from across the European Union, chaired by Professor Luke Clancy, met in Oslo, Norway, to discuss the implementation of the Tobacco Products Directive and the WHO Framework Convention on Tobacco Control, namely Article 14. On the occasion of the 10th anniversary of the Framework Convention on Tobacco Control, this paper reports the consensus reached by all Roundtable participants on the need to further advance the availability and access to services to support cessation of tobacco use. The implementation of services to support cessation of tobacco use in line with Article 14 can and should be significantly improved to protect the health of European citizens. The meeting was initiated and funded by Pfizer.

  4. European Expert Consensus Paper on the implementation of Article 14 of the WHO Framework Convention on Tobacco Control

    PubMed Central

    2016-01-01

    On 24 November 2015, under the auspices of the European Policy Roundtable on Smoking Cessation, 15 experts on tobacco control and dependence from across the European Union, chaired by Professor Luke Clancy, met in Oslo, Norway, to discuss the implementation of the Tobacco Products Directive and the WHO Framework Convention on Tobacco Control, namely Article 14. On the occasion of the 10th anniversary of the Framework Convention on Tobacco Control, this paper reports the consensus reached by all Roundtable participants on the need to further advance the availability and access to services to support cessation of tobacco use. The implementation of services to support cessation of tobacco use in line with Article 14 can and should be significantly improved to protect the health of European citizens. The meeting was initiated and funded by Pfizer. PMID:27548882

  5. Optimally controlling the internal dynamics of a randomly oriented ensemble of molecules

    NASA Astrophysics Data System (ADS)

    Turinici, Gabriel; Rabitz, Herschel

    2004-12-01

    The ultrafast control of large polyatomic molecules in the gas and condensed phases entails working with a randomly oriented ensemble. During the short control period, little reorientation may occur, especially for cases in the condensed phases. This paper addresses the degree to which all members of the ensemble may be simultaneously controlled with respect to their internal motion by a single laser pulse. It is shown that all members of the ensemble are fully controllable if any one member is. Numerical optimal control simulations also show that excellent quality full ensemble control can be achieved even with reasonable constraints placed on the control fields. Although the full ensemble may be controlled to a high degree, the control mechanism is likely to differ for each ensemble member.

  6. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial

    PubMed Central

    Zheng, Hui; Tian, Xiao-ping; Li, Ying; Liang, Fan-rong; Yu, Shu-guang; Liu, Xu-guang; Tang, Yong; Yang, Xu-guang; Yan, Jie; Sun, Guo-jie; Chang, Xiao-rong; Zhang, Hong-xing; Ma, Ting-ting; Yu, Shu-yuan

    2009-01-01

    Background Acupuncture is widely used in China to treat functional dyspepsia (FD). However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories. Design This multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control) group. The four acupoint treatment groups will focus on: (1) specific acupoints of the stomach meridian; (2) non-specific acupoints of the stomach meridian; (3) specific acupoints of alarm and transport points; and (4) acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment. Discussion The important features of this trial include the randomization procedures (controlled by a central randomization system), a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy. Trial registration number Clinical Trials.gov Identifier: NCT00599677

  7. Can Genetics Predict Response to Complex Behavioral Interventions? Evidence from a Genetic Analysis of the Fast Track Randomized Control Trial

    PubMed Central

    Albert, Dustin; Belsky, Daniel W.; Crowley, D. Max; Latendresse, Shawn J.; Aliev, Fazil; Riley, Brien; Sun, Cuie; Dick, Danielle M.; Dodge, Kenneth R.

    2014-01-01

    Early interventions are a preferred method for addressing behavioral problems in high-risk children, but often have only modest effects. Identifying sources of variation in intervention effects can suggest means to improve efficiency. One potential source of such variation is the genome. We conducted a genetic analysis of the Fast Track Randomized Control Trial, a 10-year-long intervention to prevent high-risk kindergarteners from developing adult externalizing problems including substance abuse and antisocial behavior. We tested whether variants of the glucocorticoid receptor gene NR3C1 were associated with differences in response to the Fast Track intervention. We found that in European-American children, a variant of NR3C1 identified by the single-nucleotide polymorphism rs10482672 was associated with increased risk for externalizing psychopathology in control group children and decreased risk for externalizing psychopathology in intervention group children. Variation in NR3C1 measured in this study was not associated with differential intervention response in African-American children. We discuss implications for efforts to prevent externalizing problems in high-risk children and for public policy in the genomic era. PMID:26106668

  8. Can Genetics Predict Response to Complex Behavioral Interventions? Evidence from a Genetic Analysis of the Fast Track Randomized Control Trial.

    PubMed

    Albert, Dustin; Belsky, Daniel W; Crowley, D Max; Latendresse, Shawn J; Aliev, Fazil; Riley, Brien; Sun, Cuie; Dick, Danielle M; Dodge, Kenneth A

    2015-01-01

    Early interventions are a preferred method for addressing behavioral problems in high-risk children, but often have only modest effects. Identifying sources of variation in intervention effects can suggest means to improve efficiency. One potential source of such variation is the genome. We conducted a genetic analysis of the Fast Track randomized control trial, a 10-year-long intervention to prevent high-risk kindergarteners from developing adult externalizing problems including substance abuse and antisocial behavior. We tested whether variants of the glucocorticoid receptor gene NR3C1 were associated with differences in response to the Fast Track intervention. We found that in European-American children, a variant of NR3C1 identified by the single-nucleotide polymorphism rs10482672 was associated with increased risk for externalizing psychopathology in control group children and decreased risk for externalizing psychopathology in intervention group children. Variation in NR3C1 measured in this study was not associated with differential intervention response in African-American children. We discuss implications for efforts to prevent externalizing problems in high-risk children and for public policy in the genomic era.

  9. Targeting Children's Behavior Problems in Preschool Classrooms: A Cluster-Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Raver, C. Cybele; Jones, Stephanie M.; Li-Grining, Christine; Zhai, Fuhua; Metzger, Molly W.; Solomon, Bonnie

    2009-01-01

    The present study evaluated the efficacy of a multicomponent, classroom-based intervention in reducing preschoolers' behavior problems. The Chicago School Readiness Project model was implemented in 35 Head Start classrooms using a clustered-randomized controlled trial design. Results indicate significant treatment effects (ds = 0.53-0.89) for…

  10. Double-blind randomized controlled study of coblation tonsillotomy versus coblation tonsillectomy on postoperative pain.

    PubMed

    Arya, A; Donne, A J; Nigam, A

    2003-12-01

    This double-blind randomized controlled trial of coblation tonsillotomy versus coblation tonsillectomy uses visual analogue scoring to compare the pain experienced in the 24h postoperative period. No statistically significant difference in pain is demonstrated in the group of 14 patients studied. Tonsillectomy is recommended over tonsillotomy.

  11. Ice Hockey Players Using a Weighted Implement when Training on the Ice: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Stark, Timothy W.; Tvoric, Bojan; Walker, Bruce; Noonan, Dom; Sibla, Janeene

    2009-01-01

    The purpose of this study was to investigate the potential for improving hockey players' performance using a weighted implement on the ice. Forty-eight players were tested using a grip strength dynamometer. They also were assessed on their abilities to stick-handle. The participants were randomly placed into a control or research group. The…

  12. Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

    ERIC Educational Resources Information Center

    Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

    2010-01-01

    Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

  13. Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

  14. A Randomized Controlled Study of Brief Interventions To Teach Residents about Domestic Violence.

    ERIC Educational Resources Information Center

    Coonrod, Dean V.; Bay, R. Curtis; Rowley, Beverley D.; Del Mar, Nancy B.; Gabriele, Laura; Tessman, Terrie D.; Chambliss, Linda R.

    2000-01-01

    Medical residents were randomly assigned to either a 20-minute session on the importance of screening for domestic violence or to an unrelated topic. Subsequently, 71 percent of the trained residents diagnosed at least one case of domestic violence compared to 52 percent of residents in the control group. Rates of diagnosis also differed by…

  15. Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

    This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

  16. Management of Hypertension in Private Practice: A Randomized Controlled Trial in Continuing Medical Education.

    ERIC Educational Resources Information Center

    Gullion, David S.; And Others

    1988-01-01

    A randomized control trial was used to evaluate a physician education program designed to improve physician management of patients' hypertension, hypertension-related behaviors, and diastolic blood pressure. It was suggested that more intensive continuing medical education programs are needed to improve physician performance and patient outcome.…

  17. Randomized Controlled Caregiver Mediated Joint Engagement Intervention for Toddlers with Autism

    ERIC Educational Resources Information Center

    Kasari, Connie; Gulsrud, Amanda C.; Wong, Connie; Kwon, Susan; Locke, Jill

    2010-01-01

    This study aimed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism. The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later. Compared to caregivers and toddlers randomized to the waitlist control group the immediate treatment (IT)…

  18. A Randomized Placebo-Controlled Trial of a School-Based Depression Prevention Program.

    ERIC Educational Resources Information Center

    Merry, Sally; McDowell, Heather; Wild, Chris J.; Bir, Julliet; Cunliffe, Rachel

    2004-01-01

    Objective: To conduct a placebo-controlled study of the effectiveness of a universal school-based depression prevention program. Method: Three hundred ninety-two students age 13 to 15 from two schools were randomized to intervention (RAP-Kiwi) and placebo programs run by teachers. RAP-Kiwi was an 11-session manual-based program derived from…

  19. 77 FR 26789 - Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... violation of section 337 in the infringement of certain patents. 73 FR 75131. The principal respondent was... order. 75 FR 44989-90 (July 30, 2010). The Commission also issued cease and desist orders against those... COMMISSION Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers...

  20. Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-01-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

  1. Randomized Controlled Trial of Transdermal Secretin on Behavior of Children with Autism

    ERIC Educational Resources Information Center

    Ratliff-Schaub, Karen; Carey, Tracy; Reeves, Gretchen; Rogers, Mary

    2005-01-01

    Previous trials of secretin for the treatment of autism have utilized a single or double dose administered intravenously. This is a report of a double-blind, randomized, controlled crossover trial of transdermally applied secretin in 15 children diagnosed with autism or pervasive developmental delay. Secretin or placebo was applied daily, in…

  2. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    ERIC Educational Resources Information Center

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  3. Training Anxious Children to Disengage Attention from Threat: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bar-Haim, Yair; Morag, Inbar; Glickman, Shlomit

    2011-01-01

    Background: Threat-related attention biases have been implicated in the etiology and maintenance of anxiety disorders. As a result, attention bias modification (ABM) protocols have been employed as treatments for anxious adults. However, they have yet to emerge for children. A randomized, double-blind placebo-controlled trial was conducted to…

  4. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  5. Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-01-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

  6. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

    ERIC Educational Resources Information Center

    Braam, W.; Didden, R.; Smits, M.; Curfs, L.

    2008-01-01

    Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

  7. Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

    ERIC Educational Resources Information Center

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

    2012-01-01

    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).…

  8. Mixed Results from Six Large Randomized Controlled Trials of Learning Communities in Community Colleges

    ERIC Educational Resources Information Center

    Mayer, Alexander K.; Weiss, Michael J.; Visher, Mary G.; Sommo, Colleen; Rudd, Timothy; Cullinan, Dan; Weissman, Evan; Wathington, Heather D.

    2013-01-01

    This paper presents research that explores similarities and differences across six randomized controlled trials of learning communities in community colleges that were conducted by MDRC and the National Center for Postsecondary Research. Five of these studies track students' progress in the program semester and two follow-up semesters, and one…

  9. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  10. Randomized Controlled Non-Inferiority Trial of a Telehealth Treatment for Chronic Stuttering: The Camperdown Program

    ERIC Educational Resources Information Center

    Carey, Brenda; O'Brian, Sue; Onslow, Mark; Block, Susan; Jones, Mark; Packman, Ann

    2010-01-01

    Background: Although there are treatments that can alleviate stuttering in adults for clinically significant periods, in Australia there are barriers to the accessibility and availability of best-practice treatment. Aims: This parallel group, non-inferiority randomized controlled trial with multiple blinded outcome assessments investigated whether…

  11. Computer-Assisted Learning in Elementary Reading: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Shannon, Lisa Cassidy; Styers, Mary Koenig; Wilkerson, Stephanie Baird; Peery, Elizabeth

    2015-01-01

    This study evaluated the efficacy of Accelerated Reader, a computer-based learning program, at improving student reading. Accelerated Reader is a progress-monitoring, assessment, and practice tool that supports classroom instruction and guides independent reading. Researchers used a randomized controlled trial to evaluate the program with 344…

  12. Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

    ERIC Educational Resources Information Center

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-01-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

  13. A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1

    ERIC Educational Resources Information Center

    Savage, Robert S.; Abrami, Philip; Hipps, Geoffrey; Deault, Louise

    2009-01-01

    This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http://grover.concordia.ca/abra/version1/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental…

  14. Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

    ERIC Educational Resources Information Center

    Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

    2010-01-01

    Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

  15. Working Memory Training in Young Children with ADHD: A Randomized Placebo-Controlled Trial

    ERIC Educational Resources Information Center

    Dongen-Boomsma, Martine; Vollebregt, Madelon A.; Buitelaar, Jan K.; Slaats-Willemse, Dorine

    2014-01-01

    Background: Until now, working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD; for young children with ADHD, no studies are available. To this end, a triple-blind, randomized, placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training…

  16. Lower extremity power training in elderly subjects with moderate mobility limitations: A randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fifty-seven community-dwelling older adults were randomized to either high-velocity high-power training (POW), slow-velocity progressive resistance training (STR) or a control group of lower extremity stretching (CON). Training was performed three times per week for 12 weeks and subjects completed t...

  17. Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

    ERIC Educational Resources Information Center

    Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

    2014-01-01

    This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

  18. Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  19. Improving the General Language Skills of Second-Language Learners in Kindergarten: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rogde, Kristin; Melby-Lervåg, Monica; Lervåg, Arne

    2016-01-01

    Second-language learners display poorer general language skills in the language used at school than their monolingual peers, which is a concern because general language skills (vocabulary, grammar, language expression, and comprehension) provide the foundation for later academic success. In a randomized controlled trial, we examined the efficacy…

  20. Interpretation Training in Individuals with Generalized Social Anxiety Disorder: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Amir, Nader; Taylor, Charles T.

    2012-01-01

    Objective: To examine the efficacy of a multisession computerized interpretation modification program (IMP) in the treatment of generalized social anxiety disorder (GSAD). Method: The sample comprised 49 individuals meeting diagnostic criteria for GSAD who were enrolled in a randomized, double-blind placebo-controlled trial comparing IMP (n = 23)…

  1. The Efficiency and Efficacy of Equivalence-Based Learning: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Zinn, Tracy E.; Newland, M. Christopher; Ritchie, Katie E.

    2015-01-01

    Because it employs an emergent-learning framework, equivalence-based instruction (EBI) is said to be highly efficient, but its presumed benefits must be compared quantitatively with alternative techniques. In a randomized controlled trial, 61 college students attempted to learn 32 pairs of proprietary and generic drug names using computer-based…

  2. Attachment-Based Family Therapy for Adolescents with Suicidal Ideation: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Diamond, Guy S.; Wintersteen, Matthew B.; Brown, Gregory K.; Diamond, Gary M.; Gallop, Robert; Shelef, Karni; Levy, Suzanne

    2010-01-01

    Objective: To evaluate whether Attachment-Based Family Therapy (ABFT) is more effective than Enhanced Usual Care (EUC) for reducing suicidal ideation and depressive symptoms in adolescents. Method: This was a randomized controlled trial of suicidal adolescents between the ages of 12 and 17, identified in primary care and emergency departments. Of…

  3. Vestibular Stimulation for ADHD: Randomized Controlled Trial of Comprehensive Motion Apparatus

    ERIC Educational Resources Information Center

    Clark, David L.; Arnold, L. Eugene; Crowl, Lindsay; Bozzolo, Hernan; Peruggia, Mario; Ramadan, Yaser; Bornstein, Robert; Hollway, Jill A.; Thompson, Susan; Malone, Krista; Hall, Kristy L.; Shelton, Sara B.; Bozzolo, Dawn R.; Cook, Amy

    2008-01-01

    Objective: This research evaluates effects of vestibular stimulation by Comprehensive Motion Apparatus (CMA) in ADHD. Method: Children ages 6 to 12 (48 boys, 5 girls) with ADHD were randomized to thrice-weekly 30-min treatments for 12 weeks with CMA, stimulating otoliths and semicircular canals, or a single-blind control of equal duration and…

  4. Searching for Control: Priming Randomness Increases the Evaluation of Ritual Efficacy

    ERIC Educational Resources Information Center

    Legare, Cristine H.; Souza, André L.

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual…

  5. Cycling Versus Continuous Mode In Neuromodulator Programming: A Crossover, Randomized, Controlled Trial.

    PubMed

    Beer, Gwendolyn M; Gurule, Margaret M; Komesu, Yuko M; Qualls, Clifford R; Rogers, Rebecca G

    2016-01-01

    This is a randomized, controlled, blind, crossover trial comparing cycling versus continuous programming of a sacral neuromodulator in women diagnosed with overactive bladder (OAB). At 6 months, treatment order significantly affected Overactive Bladder Questionnaire - Short Form (OABq-SF) symptom scores. The cycling followed by continuous stimulation group had superior OABq-SF scores (p > 0.02). PMID:27501593

  6. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  7. Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

    ERIC Educational Resources Information Center

    Drits-Esser, Dina; Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K-12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The…

  8. Benefits and Harms of Sick Leave: Lack of Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Axelsson, Inge; Marnetoft, Sven-Uno

    2010-01-01

    The aim of this study was to try to identify those randomized controlled trials that compare sick leave with no sick leave or a different duration or degree of sick leave. A comprehensive, systematic, electronic search of Clinical Evidence, the Cochrane Library and PubMed, and a manual search of the Campbell Library and a journal supplement was…

  9. Reconsidering Findings of "No Effects" in Randomized Control Trials: Modeling Differences in Treatment Impacts

    ERIC Educational Resources Information Center

    Chaney, Bradford

    2016-01-01

    The primary technique that many researchers use to analyze data from randomized control trials (RCTs)--detecting the average treatment effect (ATE)--imposes assumptions upon the data that often are not correct. Both theory and past research suggest that treatments may have significant impacts on subgroups even when showing no overall effect.…

  10. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

    ERIC Educational Resources Information Center

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

    The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

  11. Covariate Adjustment Strategy Increases Power in the Randomized Controlled Trial With Discrete-Time Survival Endpoints

    ERIC Educational Resources Information Center

    Safarkhani, Maryam; Moerbeek, Mirjam

    2013-01-01

    In a randomized controlled trial, a decision needs to be made about the total number of subjects for adequate statistical power. One way to increase the power of a trial is by including a predictive covariate in the model. In this article, the effects of various covariate adjustment strategies on increasing the power is studied for discrete-time…

  12. Service Learning in Medical and Nursing Training: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, A. Y. M.; Chan, S. S. C.; Kwan, C. W.; Cheung, M. K. T.; Leung, S. S. K.; Fong, D. Y. T.

    2012-01-01

    The purpose of this study was to explore the long term effect of a service learning project on medical and nursing students' knowledge in aging and their attitudes toward older adults. A total of 124 students were recruited and then randomized to intervention group (IG) and control group (CG). A pre-and-post-intervention design measured students'…

  13. An Empirical Comparison of Randomized Control Trials and Regression Discontinuity Estimations

    ERIC Educational Resources Information Center

    Barrera-Osorio, Felipe; Filmer, Deon; McIntyre, Joe

    2014-01-01

    Randomized controlled trials (RCTs) and regression discontinuity (RD) studies both provide estimates of causal effects. A major difference between the two is that RD only estimates local average treatment effects (LATE) near the cutoff point of the forcing variable. This has been cited as a drawback to RD designs (Cook & Wong, 2008).…

  14. Thinking outside the Randomized Controlled Trials Experimental Box: Strategies for Enhancing Credibility and Social Justice

    ERIC Educational Resources Information Center

    Hesse-Biber, Sharlene

    2013-01-01

    Some evaluators employ randomized controlled trials (RCTs) as the gold standard of evidence-based practice (EBP). Critics of RCT designs argue that RCTs do not include the complexity of program participants' experiences or clinical expertise, and couple this with criticisms that it is difficult to transfer RCT findings from the laboratory to…

  15. A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

    ERIC Educational Resources Information Center

    Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

    2014-01-01

    Objective: To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants: Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods: Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list…

  16. Learning What Works in ITS from Non-Traditional Randomized Controlled Trial Data

    ERIC Educational Resources Information Center

    Pardos, Zachary A.; Dailey, Matthew D.; Heffernan, Neil T.

    2011-01-01

    The well established, gold standard approach to finding out what works in education research is to run a randomized controlled trial (RCT) using a standard pre-test and post-test design. RCTs have been used in the intelligent tutoring community for decades to determine which questions and tutorial feedback work best. Practically speaking, however,…

  17. Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction

    ERIC Educational Resources Information Center

    Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C.

    2016-01-01

    Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard…

  18. Computerized Training of Working Memory in Children with ADHD-A Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Klingberg, Torkel; Fernell, Elisabeth; Olesen, Pernille J.; Johnson, Mats; Gustafsson, Per; Dahlstrom, Kerstin; Gillberg, Christopher G.; Forssberg, Hans; Westerberg, Helena

    2005-01-01

    Objective: Deficits in executive functioning, including working memory (WM) deficits, have been suggested to be important in attention-deficit/hyperactivity disorder (ADHD). During 2002 to 2003, the authors conducted a multicenter, randomized, controlled, double-blind trial to investigate the effect of improving WM by computerized, systematic…

  19. Treatment Preferences Affect the Therapeutic Alliance: Implications for Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Iacoviello, Brian M.; McCarthy, Kevin Scott; Barrett, Marna S.; Rynn, Moira; Gallop, Robert; Barber, Jacques P.

    2007-01-01

    The influence of treatment preferences on the development of the therapeutic alliance was investigated. Seventy-five patients were followed while participating in a randomized controlled trial comparing supportive-expressive psychotherapy with sertraline or pill placebo in the treatment of major depressive disorder. Therapeutic alliance was…

  20. A Randomized Controlled Trial of a Behavioral Economic Supplement to Brief Motivational Interventions for College Drinking

    ERIC Educational Resources Information Center

    Murphy, James G.; Dennhardt, Ashley A.; Skidmore, Jessica R.; Borsari, Brian; Barnett, Nancy P.; Colby, Suzanne M.; Martens, Matthew P.

    2012-01-01

    Objective: Behavioral economic theory suggests that a reduction in substance use is most likely when there is an increase in rewarding substance-free activities. The goal of this randomized controlled clinical trial was to evaluate the incremental efficacy of a novel behavioral economic supplement (Substance-Free Activity Session [SFAS]) to a…

  1. The Effectiveness of Healthy Start Home Visit Program: Cluster Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

    Purpose: The study reported the effectiveness of a home visit program for disadvantaged Chinese parents with preschool children, using cluster randomized controlled trial design. Method: Participants included 191 parents and their children from 24 preschools, with 84 dyads (12 preschools) in the intervention group and 107 dyads (12 preschools) in…

  2. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    ERIC Educational Resources Information Center

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  3. Theory of Mind Training in Children with Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Begeer, Sander; Gevers, Carolien; Clifford, Pamela; Verhoeve, Manja; Kat, Kirstin; Hoddenbach, Elske; Boer, Frits

    2011-01-01

    Many children with Autism Spectrum Disorders (ASD) participate in social skills or Theory of Mind (ToM) treatments. However, few studies have shown evidence for their effectiveness. The current study used a randomized controlled design to test the effectiveness of a 16-week ToM treatment in 8-13 year old children with ASD and normal IQs (n = 40).…

  4. A multicomponent behavioral intervention to reduce stroke risk factor behaviors: The SHARE Cluster-Randomized Controlled Trial

    PubMed Central

    Brown, Devin L.; Conley, Kathleen M.; Sánchez, Brisa N.; Resnicow, Kenneth; Cowdery, Joan E.; Sais, Emma; Murphy, Jillian; Skolarus, Lesli E.; Lisabeth, Lynda D.; Morgenstern, Lewis B.

    2015-01-01

    Background and Purpose The Stroke Health and Risk Education (SHARE) Project was a cluster-randomized, faith-based, culturally-sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Methods Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the three outcomes was significant at the 0.05/3 level. Results Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53; 84% were Hispanic/Latino; 64% were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day (95% CI: 0.08, 0.42), p = 0.002), a greater decrease in sodium intake (−123.17 mg/day (−194.76, −51.59), p=0.04), but no difference in change in moderate or greater intensity physical activity (−27 MET-minutes per week (−526, 471), p=0.56). Conclusions This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary endpoint. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. PMID:26374480

  5. Refining Operational Practice for Controlling Introduced European Rabbits on Agricultural Lands in New Zealand

    PubMed Central

    Latham, A. David M.; Latham, M. Cecilia; Nugent, Graham; Smith, James; Warburton, Bruce

    2016-01-01

    European rabbits (Oryctolagus cuniculus) pose a major threat to agricultural production and conservation values in several countries. In New Zealand, population control via poisoning is a frontline method for limiting rabbit damage, with large areas commonly treated using the metabolic toxin sodium fluoroacetate (‘1080’) delivered in bait via aerial dispersal. However, this method is expensive and the high application rates of the active ingredient cause public antipathy towards it. To guide reductions in cost and toxin usage, we evaluated the economics and efficacy of rabbit control using an experimental approach of sowing 1080-bait in strips instead of the commonly-used broadcast sowing method (i.e. complete coverage). Over a 4-year period we studied aerial delivery of 0.02% 1080 on diced carrot bait over ~3500 ha of rabbit-prone land in the North and South islands. In each case, experimental sowing via strip patterns using 10–15 kg of bait per hectare was compared with the current best practice of aerial broadcast sowing at 30–35 kg/ha. Operational kill rates exceeded 87% in all but one case and averaged 93–94% across a total of 19 treatment replicates under comparable conditions; there was no statistical difference in overall efficacy observed between the two sowing methods. We project that strip-sowing could reduce by two thirds the amount of active 1080 applied per hectare in aerial control operations against rabbits, both reducing the non-target poisoning risk and promoting cost savings to farming operations. These results indicate that, similarly to the recently-highlighted benefits of adopting strip-sowing for poison control of introduced brushtail possums (Trichosurus vulpecula) in New Zealand, aerial strip-sowing of toxic bait could also be considered a best practice method for rabbit control in pest control policy. PMID:27341209

  6. Refining Operational Practice for Controlling Introduced European Rabbits on Agricultural Lands in New Zealand.

    PubMed

    Latham, A David M; Latham, M Cecilia; Nugent, Graham; Smith, James; Warburton, Bruce

    2016-01-01

    European rabbits (Oryctolagus cuniculus) pose a major threat to agricultural production and conservation values in several countries. In New Zealand, population control via poisoning is a frontline method for limiting rabbit damage, with large areas commonly treated using the metabolic toxin sodium fluoroacetate ('1080') delivered in bait via aerial dispersal. However, this method is expensive and the high application rates of the active ingredient cause public antipathy towards it. To guide reductions in cost and toxin usage, we evaluated the economics and efficacy of rabbit control using an experimental approach of sowing 1080-bait in strips instead of the commonly-used broadcast sowing method (i.e. complete coverage). Over a 4-year period we studied aerial delivery of 0.02% 1080 on diced carrot bait over ~3500 ha of rabbit-prone land in the North and South islands. In each case, experimental sowing via strip patterns using 10-15 kg of bait per hectare was compared with the current best practice of aerial broadcast sowing at 30-35 kg/ha. Operational kill rates exceeded 87% in all but one case and averaged 93-94% across a total of 19 treatment replicates under comparable conditions; there was no statistical difference in overall efficacy observed between the two sowing methods. We project that strip-sowing could reduce by two thirds the amount of active 1080 applied per hectare in aerial control operations against rabbits, both reducing the non-target poisoning risk and promoting cost savings to farming operations. These results indicate that, similarly to the recently-highlighted benefits of adopting strip-sowing for poison control of introduced brushtail possums (Trichosurus vulpecula) in New Zealand, aerial strip-sowing of toxic bait could also be considered a best practice method for rabbit control in pest control policy. PMID:27341209

  7. Randomized controlled trials in relapsed/refractory follicular lymphoma: a systematic review and meta-analysis.

    PubMed

    Police, Rachel L; Trask, Peter C; Wang, Jianmin; Olivares, Robert; Khan, Shahnaz; Abbe, Adeline; Colosia, Ann; Njue, Annete; Sherril, Beth; Ruiz-Soto, Rodrigo; Kaye, James A; Hamadani, Mehdi

    2016-10-01

    This systematic literature review evaluated the clinical efficacy and safety of interventions used in relapsed/refractory follicular lymphoma. Primary efficacy outcomes were objective response rate, progression-free survival and overall survival. Safety endpoints were grade 3/4 toxicities, serious adverse events and withdrawals or deaths due to toxicity. Studies were selected if they were randomized controlled trials reporting on the efficacy or safety of treatments for relapsed or refractory follicular lymphoma, and if outcomes were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 10 randomized controlled trials of treatments for relapsed/refractory follicular lymphoma. The most prominent drug investigated (alone or in combination) was rituximab. Most trials did not report median overall survival. Two trials reported median event-free survival (range, 1.2-23.2 months). Six of ten trials reported objective response rate (range, 9-93%). Meta-analysis showed only one statistically significant result: rituximab + bortezomib yielded a significantly higher objective response rate than rituximab monotherapy (relative risk, 1.28; 95% confidence interval, 1.11-1.47). Otherwise, there were no discernable differences in overall survival or progression-free survival, partly due to insufficient reporting of results in the clinical trials. The relatively small number of randomized controlled trials, few overlapping treatment arms, and variability in the randomized controlled trial features and in the endpoints studied complicate the formal comparison of therapies for relapsed/refractory follicular lymphoma. Additional well-designed randomized controlled trials are needed to fully understand the relative outcomes of older and more recently developed therapies. PMID:26320127

  8. Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent Versus Sequential Intervention.

    ERIC Educational Resources Information Center

    Spring, Bonnie; Pagoto, Sherry; Pingitore, Regina; Doran, Neal; Schneider, Kristin; Hedeker, Don

    2004-01-01

    The authors compared simultaneous versus sequential approaches to multiple health behavior change in diet, exercise, and cigarette smoking. Female regular smokers (N = 315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit smoking at Week 5, and were followed for 9 months after quit date. Weight management was…

  9. Factors controlling spatial variability of DOC concentrations in soil solution at European level

    NASA Astrophysics Data System (ADS)

    Camino Serrano, Marta; Janssens, Ivan; Luyssaert, Sebastiaan; Gielen, Bert; Guenet, Bertrand; De Vos, Bruno; Ciais, Philippe

    2013-04-01

    The lateral transport of dissolved organic carbon (DOC) is an important and not well-understood process linking terrestrial and aquatic ecosystems. Up to day very few Earth System Models (ESMs) represent explicitly this process despite its crucial role in the global carbon cycle. However, to be able to integrate DOC leaching in ESMs, more accurate information is needed in order to better understand and predict DOC dynamics. DOC concentrations mainly vary by geographical location, soil and vegetation types, topography, season and climate. Within this framework, a database was designed to compile data on DOC in soil solution at different depths in different ecosystems around the world, with special focus on European sites. The database contains information on 349 sites, with 304 being forest, gathered from published literature and datasets accessible on the internet. A substantial dataset was provided by International Co-operative Programme on Assessment and Monitoring of Air Pollution Effects on Forests (ICP Forests). The database also includes other meta-data related to the sites, such as land cover, soil properties, climate, annual water balance and other soil solution parameters. The analysis of the database has been focused on: 1) the study of the environmental and physical factors that are acting as drivers of DOC concentrations changes in soil solution across sites at European level , and 2) the DOC distribution through the soil profile and how this varies with different vegetation types and soil properties. The preliminary results show that variables related to biological processes (Dry weight of the organic layer, for example) are the most important in explaining the spatial distribution of the DOC concentration in soil solution at the European scale. However, the interactions between variables are complex and we will need further analysis in order to draw more robust conclusions. With regards to the vertical profile of DOC, we found that there is a

  10. Unicursal random maze tool path for computer-controlled optical surfacing.

    PubMed

    Wang, Chunjin; Wang, Zhenzhong; Xu, Qiao

    2015-12-01

    A novel unicursal random maze tool path is proposed in this paper, which can not only implement uniform coverage of the polishing surfaces, but also possesses randomness and multidirectionality. The simulation experiments along with the practical polishing experiments are conducted to make the comparison of three kinds of paths, including maze path, raster path, and Hilbert path. The experimental results validate that the maze path can warrant uniform polishing and avoid the appearance of the periodical structures in the polished surface. It is also more effective than the Hilbert path in restraining the mid-spatial frequency error in computer-controlled optical surfacing process.

  11. Role of Surgical Dressings in Total Joint Arthroplasty: A Randomized Controlled Trial.

    PubMed

    Springer, Bryan D; Beaver, Walter B; Griffin, William L; Mason, J Bohannon; Odum, Susan M

    2015-09-01

    We conducted a randomized controlled trial to compare efficacy of an occlusive antimicrobial barrier dressing and a standard surgical dressing in patients who underwent primary total joint arthroplasty. Two hundred sixty-two patients were randomized to receive either an occlusive dressing or a standard dressing. Wounds were closed in identical fashion. Outcomes included wound complications, dressing changes, and patient satisfaction. With use of occlusive dressing (vs standard dressing), wound complications (including skin blistering) were significantly (P = 0.15) reduced; there were significantly (P < .0001) fewer dressing changes; and patient satisfaction was significantly (P < .0001) higher. Use of occlusive dressings can reduce wound complications and promote wound healing after total joint arthroplasty.

  12. Human factors requirements for telerobotic command and control: The European Space Agency experimental programme

    NASA Technical Reports Server (NTRS)

    Stone, Robert J.

    1991-01-01

    Space Telerobotics research, performed under contract to the European Space Agency (ESA), concerning the execution of human factors experiments, and ultimately leading to the development of a telerobotics test bed, has been carried out since 1985 by a British Consortium consisting of British Aerospace, the United Kingdom Atomic Energy Authority and, more recently, the UK National Advanced Robotics Research Centre. The principal aim of the first study of the series was to derive preliminary requirements for a teleoperation servicing system, with reference to two mission model scenarios. The first scenario introduced the problem of communications time delays, and their likely effect on the ground-based operator in control of a manipulator system on board an unmanned servicing vehicle in Low Earth Orbit. In the second scenario, the operator was located on the NASA Orbiter aft flight deck, supervising the control of a prototype manipulator in the 'servicing' of an experimental payload in the cargo bay area. Human factors analyses centered on defining the requirements for the teleoperator workstation, such as identifying basic ergonomic requirements for workstation and panel layouts, defining teleoperation strategies, developing alphanumeric and graphic screen formats for the supervision or direct control of the manipulator, and the potential applications of expert system technology. The second study for ESA involved an experimental appraisal of some of the important issues highlighted in the first study, for which relevant human factors data did not exist. Of central importance during the second study was the issue of communications time delays and their effect on the manual control of a teleoperated manipulator from a ground-based command and control station.

  13. FMD vaccines: reflections on quality aspects for applicability in European disease control policy.

    PubMed

    De Clercq, K; Goris, N; Barnett, P V; MacKay, D K

    2008-01-01

    Most foot-and-mouth disease (FMD) vaccines used around the world are inactivated vaccines for prophylactic or emergency use, generally manufactured by the same basic methodology outlined in the OIE Manual and, for Europe, in the European Pharmacopoeia, and for the EU Member States in compliance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products as amended by Directive 2004/28/EC. Most of the requirements that apply to all immunological veterinary medicinal products apply equally to FMD vaccines. There are, however, some unique features of the disease and vaccines used against it that require a different approach to fulfil the requirements of the relevant legislation, if a vaccinate-to-live policy will be applied with 'authorized' vaccines. Several aspects of vaccine efficacy and safety are elaborated with emphasis on quality assurance/quality control (QA/QC). The purity of the vaccine in respect of the presence of non-structural protein antibodies could be checked indirectly by serology after vaccination. The viability of a vaccine bank approach was greatly aided by the principle of storing inactivated concentrated FMD viral antigen (Ag) over liquid nitrogen for subsequent formulation into vaccine. A worldwide Ag bank network might be an option for the far future and a solution to the problem of covering many different FMDV serotypes and strains. The producers should respect the strict FMD biosecurity rules worked out by the FAO EUFMD and described in Council Directive 2003/85/EC. Making the experience related to vaccine QA/QC available to all countries will reduce the risk of an FMD outbreak within these countries and consequently will reduce the FMD risk around the world.

  14. A PARENT–ADOLESCENT INTERVENTION TO INCREASE SEXUAL RISK COMMUNICATION: RESULTS OF A RANDOMIZED CONTROLLED TRIAL

    PubMed Central

    Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan

    2009-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent–adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HTV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6– and 12–month follow–ups. Generalized estimation equation (GEE) analysis indicates parents in the HIV risk reduction intervention reported significantly more general communication (p < .005), more sexual risk communication (p < .001) and more comfort with communication (p < .001) than parents in the control intervention. Behavioral, normative, and control beliefs significantly mediated the effect of the intervention on all communication outcomes. This study demonstrates the efficacy of an intervention to increase the quality and quantity of parent–adolescent communication related to general and sex–specific communication. PMID:18956979

  15. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery.

    PubMed

    Healy, D A; Boyle, E; McCartan, D; Bourke, M; Medani, M; Ferguson, J; Yagoub, H; Bashar, K; O'Donnell, M; Newell, J; Canning, C; McMonagle, M; Dowdall, J; Cross, S; O'Daly, S; Manning, B; Fulton, G; Kavanagh, E G; Burke, P; Grace, P A; Moloney, M Clarke; Walsh, S R

    2015-11-01

    A pilot randomized controlled trial that evaluated the effect of remote ischemic preconditioning (RIPC) on clinical outcomes following major vascular surgery was performed. Eligible patients were those scheduled to undergo open abdominal aortic aneurysm repair, endovascular aortic aneurysm repair, carotid endarterectomy, and lower limb revascularization procedures. Patients were randomized to RIPC or to control groups. The primary outcome was a composite clinical end point comprising any of cardiovascular death, myocardial infarction, new-onset arrhythmia, cardiac arrest, congestive cardiac failure, cerebrovascular accident, renal failure requiring renal replacement therapy, mesenteric ischemia, and urgent cardiac revascularization. Secondary outcomes were components of the primary outcome and myocardial injury as assessed by serum troponin values. The primary outcome occurred in 19 (19.2%) of 99 controls and 14 (14.1%) of 99 RIPC group patients (P = .446). There were no significant differences in secondary outcomes. Our trial generated data that will guide future trials. Further trials are urgently needed.

  16. Key analytic considerations in design and analysis of randomized controlled trials in osteoarthritis

    PubMed Central

    Losina, Elena; Ranstam, Jonas; Collins, Jamie; Schnitzer, Thomas J; Katz, Jeffrey N.

    2016-01-01

    Objective To highlight methodologic challenges pertinent to design, analysis, and reporting of results of randomized clinical trials in OA and offer practical suggestions to overcome these challenges. Design The topics covered in this paper include subject selection, randomization, approaches to handling missing data, subgroup analysis, sample size, and issues related to changing design mid-way through the study. Special attention is given to standardizing the reporting of results and economic analyses. Results Key findings include the importance of blinding and concealment, the distinction between superiority and non-inferiority trials, the need to minimize missing data, and appropriate analysis and interpretation of subgroup effects. Conclusion Investigators may use the findings and recommendations advanced in this paper to guide design and conduct of randomized controlled trials of interventions for osteoarthritis. PMID:25952341

  17. Can attention control conditions have detrimental effects in behavioral medicine randomized trials?

    PubMed Central

    Pagoto, Sherry; McDermott, Mary M.; Reed, George; Greenland, Philip; Mazor, Kathy M.; Ockene, Judith K.; Whited, Matt; Schneider, Kristin; Appelhans, Brad; Leung, Kathy; Merriam, Philip; Ockene, Ira

    2012-01-01

    Objective Attention control conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance is available in the literature about which behavioral interventions and outcomes merit an attention control. The primary aim of the present paper is to demonstrate a scenario in which use of attention control in a behavioral randomized trial was unnecessary and possibly detrimental. Methods Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered telephone counseling (PC) intervention reduced low-density lipoprotein cholesterol (LDL-C) levels in 355 participants with peripheral arterial disease (PAD), compared to attention control (AC) and usual care (UC) conditions. The PC intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched phone-delivered health education, and the UC condition consisted of an educational pamphlet. Results At 12-month follow-up, mean LDL-C changes were −11.1, and −6.8 mg/dl in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased use or dose intensity of medication was significantly lower in AC than UC, 17.5% versus 30.5% (p=0.03). No significant difference between AC and UC were observed on other outcomes. Conclusions The AC had significantly worse medication outcomes and there was no indication of a therapeutic effect on other endpoints. Implications for use of attention control in behavioral randomized trials are discussed. PMID:23197844

  18. Integrating biological and chemical controls in decision making: European corn borer (Lepidoptera: Crambidae) control in sweet corn as an example.

    PubMed

    Musser, Fred R; Nyrop, Jan P; Shelton, Anthony M

    2006-10-01

    As growers switch to transgenic crops and selective insecticides that are less toxic to natural enemies, natural enemies can become more important in agricultural pest management. Current decision-making guides are generally based on pest abundance and do not address pest and natural enemy toxicity differences among insecticides or the impact of natural enemies on pest survival. A refined approach to making pest management decisions is to include the impact of natural enemies and insecticides, thereby better integrating biological and chemical control. The result of this integration is a dynamic threshold that varies for each product and the level of biological control expected. To demonstrate the significance of conserved biological control in commercial production, a decision-making guide was developed that evaluates control options for European corn borer, Ostrinia nubilalis (Hübner) (Lepidoptera: Crambidae), in sweet corn, Zea mays L., where the primary natural enemies are generalist predators. Management options are lambda-cyhalothrin (broad-spectrum insecticide), spinosad (selective insecticide), Trichogramma ostriniae (Peng and Chen) (Hymenoptera: Trichogrammatidae) (parasitoid), and Bacillus thuringiensis (Bt) sweet corn (transgenic variety). The key factors influencing thresholds for all treatments are the intended market, predator populations, and the presence of alternative foods for the predators. Treatment cost is the primary factor separating the threshold for each treatment within a common scenario, with the lowest cost treatment having the lowest pest threshold. However, when the impact of a treatment on natural enemies is projected over the 3-wk control period, the impact of the treatment on predators becomes the key factor in determining the threshold, so the lowest thresholds are for broad-spectrum treatments, whereas selective products can have thresholds > 6 times higher by the third week. This decision guide can serve as a framework to help

  19. Impact of the training on the compliance and persistence of weekly bisphosphonate treatment in postmenopausal osteoporosis: a randomized controlled study.

    PubMed

    Tüzün, Şansın; Akyüz, Gülseren; Eskiyurt, Nurten; Memiş, Asuman; Kuran, Banu; İçağasıoğlu, Afitap; Sarpel, Tunay; Özdemir, Ferda; Özgirgin, Neşe; Günaydın, Rezzan; Cakçı, Aytül; Yurtkuran, Merih

    2013-01-01

    Long-term patient adherence to osteoporosis treatment is poor despite proven efficacy. In this study, we aimed to assess the impact of active patient training on treatment compliance and persistence in patients with postmenopausal osteoporosis. In the present national, multicenter, randomized controlled study, postmenopausal osteoporosis patients (45-75 years) who were on weekly bisphosphonate treatment were randomized to active training (AT) and passive training (PT) groups and followed-up by 4 visits after the initial visit at 3 months interval during 12 months of the treatment. Both groups received a bisphosphonate usage guide and osteoporosis training booklets. Additionally, AT group received four phone calls (at 2(nd), 5(th), 8(th), and 11(th) months) and participated to four interactive social/training meetings held in groups of 10 patients (at 3(rd), 6(th), 9(th), and 12(th) months). The primary evaluation criteria were self-reported persistence and compliance to the treatment and the secondary evaluation criteria was quality life of the patients assessed by 41-item Quality of Life European Foundation for Osteoporosis (QUALEFFO-41) questionnaire. Of 448 patients (mean age 62.4±7.7 years), 226 were randomized to AT group and 222 were randomized to PT group. Among the study visits, the most common reason for not receiving treatment regularly was forgetfulness (54.9% for visit 2, 44.3% for visit 3, 51.6% for visit 4, and 43.8% for visit 5), the majority of the patients always used their drugs regularly on recommended days and dosages (63.8% for visit 2, 60.9% for visit 3, 72.1% for visit 4, and 70.8% for visit 5), and most of the patients were highly satisfied with the treatment (63.4% for visit 2, 68.9% for visit 3, 72.4% for visit 4, and 65.2% for visit 5) and wanted to continue to the treatment (96.5% for visit 2, 96.5% for visit 3, 96.9% for visit 4, and 94.4% for visit 5). QUALEFFO scores of the patients in visit 1 significantly improved in visit 5 (37.7

  20. The Saving and Empowering Young Lives in Europe (SEYLE) Randomized Controlled Trial (RCT): methodological issues and participant characteristics

    PubMed Central

    2013-01-01

    Background Mental health problems and risk behaviours among young people are of great public health concern. Consequently, within the VII Framework Programme, the European Commission funded the Saving and Empowering Young Lives in Europe (SEYLE) project. This Randomized Controlled Trial (RCT) was conducted in eleven European countries, with Sweden as the coordinating centre, and was designed to identify an effective way to promote mental health and reduce suicidality and risk taking behaviours among adolescents. Objective To describe the methodological and field procedures in the SEYLE RCT among adolescents, as well as to present the main characteristics of the recruited sample. Methods Analyses were conducted to determine: 1) representativeness of study sites compared to respective national data; 2) response rate of schools and pupils, drop-out rates from baseline to 3 and 12 month follow-up, 3) comparability of samples among the four Intervention Arms; 4) properties of the standard scales employed: Beck Depression Inventory, Second Edition (BDI-II), Zung Self-Rating Anxiety Scale (Z-SAS), Strengths and Difficulties Questionnaire (SDQ), World Health Organization Well-Being Scale (WHO-5). Results Participants at baseline comprised 12,395 adolescents (M/F: 5,529/6,799; mean age=14.9±0.9) from Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain. At the 3 and 12 months follow up, participation rates were 87.3% and 79.4%, respectively. Demographic characteristics of participating sites were found to be reasonably representative of their respective national population. Overall response rate of schools was 67.8%. All scales utilised in the study had good to very good internal reliability, as measured by Cronbach’s alpha (BDI-II: 0.864; Z-SAS: 0.805; SDQ: 0.740; WHO-5: 0.799). Conclusions SEYLE achieved its objective of recruiting a large representative sample of adolescents within participating European countries. Analysis

  1. Creation and implementation of a historical controls database from randomized clinical trials

    PubMed Central

    Desai, Jigar R; Bowen, Edward A; Danielson, Mark M; Allam, Rajasekhar R; Cantor, Michael N

    2013-01-01

    Background Ethical concerns about randomly assigning patients to suboptimal or placebo arms and the paucity of willing participants for randomization into control and experimental groups have renewed focus on the use of historical controls in clinical trials. Although databases of historical controls have been advocated, no published reports have described the technical and informatics issues involved in their creation. Objective To create a historical controls database by leveraging internal clinical trial data at Pfizer, focusing on patients who received only placebo in randomized controlled trials. Methods We transformed disparate clinical data sources by indexing, developing, and integrating clinical data within internal databases and archives. We focused primarily on trials mapped into a consistent standard and trials in the pain therapeutic area as a pilot. Results Of the more than 20 000 internal Pfizer clinical trials, 2404 completed placebo controlled studies with a parallel design were identified. Due to challenges with informed consent and data standards used in older clinical trials, studies completed before 2000 were excluded, yielding 1134 studies from which placebo subjects and associated clinical data were extracted. Conclusions It is technically feasible to pool portions of placebo populations through a stratification and segmentation approach for a historical placebo group database. A sufficiently large placebo controls database would enable previous distribution calculations on representative populations to supplement, not eliminate, the placebo arm of future clinical trials. Creation of an industry-wide placebo controls database, utilizing a universal standard, beyond the borders of Pfizer would add significant efficiencies to the clinical trial and drug development process. PMID:23449762

  2. A systematic review of randomized controlled trials on sterilization methods of extracted human teeth

    PubMed Central

    Western, J. Sylvia; Dicksit, Daniel Devaprakash

    2016-01-01

    Aim of this Study: The aim was to evaluate the efficiency of different sterilization methods on extracted human teeth (EHT) by a systematic review of in vitro randomized controlled trials. Methodology: An extensive electronic database literature search concerning the sterilization of EHT was conducted. The search terms used were “human teeth, sterilization, disinfection, randomized controlled trials, and infection control.” Randomized controlled trials which aim at comparing the efficiency of different methods of sterilization of EHT were all included in this systematic review. Results: Out of 1618 articles obtained, eight articles were selected for this systematic review. The sterilization methods reviewed were autoclaving, 10% formalin, 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C. Data were extracted from the selected individual studies and their findings were summarized. Conclusion: Autoclaving and 10% formalin can be considered as 100% efficient and reliable methods. While the use of 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C was inefficient and unreliable methods of sterilization of EHT. PMID:27563183

  3. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study.

    PubMed

    John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

    2016-01-01

    Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118. PMID:27088040

  4. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

    PubMed Central

    John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

    2016-01-01

    Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118. PMID:27088040

  5. Riposte to Guest Commentaries on 'Problems associated with randomized controlled clinical trials in breast cancer.

    PubMed

    Johnson, A E

    1998-08-01

    This paper addresses the objections of Professor M. Baum and Mr W. J. Cunliffe to my thesis that the randomized controlled clinical trial is a poor tool for the investigation of the treatment of breast cancer, argued in a discussion paper entitled 'Problems associated with randomized controlled clinical trials in breast cancer' (A.E. Johnson, 1998, Journal of Evaluation in Clinical Practice 4, 119-126). The objections range from those that have a philosophical basis, through those founded on differing concepts of the classification of primary tumours and the nature of the metastatic tumour, to those that question the reliability and usefulness of the clinical evaluation of response to treatment in terms of histological grade and rate of tumour shrinkage. An alternative approach to research through primary systemic therapy with selection of treatment according to predicted tumour behaviour was severely criticized, both on the preceding grounds and because it was assumed that the alternative to randomization is management by anecdote. These objections are examined and evidence in support of reliable and useful clinical measurement of response is presented in some detail. The problems associated with randomization as a technique for the evaluation of treatments, when the intrinsic variability of tumours is very large without the intervention of treatment, remain unsolved.

  6. Searching for control: priming randomness increases the evaluation of ritual efficacy.

    PubMed

    Legare, Cristine H; Souza, André L

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual action and a desired outcome. Two experiments were conducted (one in Brazil [n = 40] and another in the United States [n = 94]) to evaluate how the perceived efficacy of rituals is affected by feelings of randomness. In a between-subjects design, the Scramble Sentence Task was used as a priming procedure in three conditions (i.e., randomness, negativity, and neutral) and participants were then asked to rate the efficacy of rituals used for problem-solving purposes. The results demonstrate that priming randomness increased participants' perception of ritual efficacy relative to negativity and neutral conditions. Implications for increasing our understanding of the relationship between perceived control and ritualistic behavior are discussed. PMID:23941272

  7. Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: A randomized placebo-controlled phase III study

    SciTech Connect

    Buentzel, Jens . E-mail: jens.buentzel@shk-ndh.de; Micke, Oliver; Adamietz, Irenaus A.; Monnier, Alain; Glatzel, Michael; Vries, Alexander de

    2006-03-01

    Purpose: Clinical trials demonstrated the efficacy and safety of intravenous (i.v.) or subcutaneous (s.c.) amifostine for reducing xerostomia and mucositis after radiotherapy or radiochemotherapy for head-and-neck cancer. This randomized, double-blinded, placebo-controlled, phase III study evaluated the efficacy and safety of i.v. amifostine during radiochemotherapy for head-and-neck cancer. Methods and Materials: Patients from European and American study centers received i.v. amifostine 300 mg/m{sup 2} (n = 67) or placebo (n = 65) before carboplatin 70 mg/m{sup 2} and radiotherapy on Days 1 to 5 and 21 to 25, and i.v. amifostine 200 mg/m{sup 2} or placebo before radiotherapy on other days. Results: Toxicity incidences were (amifostine, placebo, p value): Grade 2 or higher acute xerostomia (39%, 34%, 0.715), Grade 3 or higher acute mucositis (39%, 22%, 0.055), Grade 2 or higher late xerostomia (37%, 24%, 0.235), and Grade 3 or higher treatment-related adverse events (42%, 20%, 0.008). One-year rates of locoregional failure, progression-free survival, and overall survival were not significantly different between treatments. Conclusions: The used amifostine doses were not able to reduce the toxicity of simultaneous radiochemotherapy for head-and-neck cancer. The safety of amifostine and the lack of tumor protection were consistent with previous studies.

  8. Randomized Controlled Trial of a Web-based Indoor Tanning Intervention: Acceptability and Preliminary Outcomes

    PubMed Central

    Stapleton, Jerod L.; Manne, Sharon L.; Darabos, Katie; Greene, Kathryn; Ray, Anne E.; Turner, Amber L.; Coups, Elliot J.

    2015-01-01

    Objective This manuscript describes the acceptability and preliminary behavioral outcomes from a pilot randomized control trial of a web-based indoor tanning intervention for young adult women. The intervention targets indoor tanning user’s perceptions of then benefits and value of tanning and addresses the role of body image-related constructs in indoor tanning. Methods Participants were 186 young adult women who reported indoor tanning at least once in the past 12 months. The study design was a 2-arm randomized controlled trial with pre and post assessments and random assignment to an intervention or control condition. Intervention acceptability was assessed by obtaining participants’ evaluation of the intervention. Regression analyses were used to test for intervention condition differences in preliminary behavioral outcomes measured at 6-weeks post-intervention. Results Participants provided favorable evaluations of the intervention on several dimensions and a highly positive overall rating. Intervention participants were more likely to report abstaining from indoor tanning and indicated a lower likelihood of using indoor tanning in the future compared to control participants on the post-intervention assessment. No differences were found for sunburns. Conclusions The results of this pilot randomized controlled trial provide evidence that the indoor tanning intervention is acceptable to participants and may encourage cessation of indoor tanning behavior. The findings provide preliminary support for an indoor tanning intervention that engages tanners to challenge their beliefs about the benefits of indoor tanning. The use of a web-based indoor tanning intervention is unique and provides strong potential for dissemination. PMID:26651469

  9. Reinforcement Behavior Therapy by Kindergarten Teachers on Preschool Children’s Aggression: A Randomized Controlled Trial

    PubMed Central

    Yektatalab, Shahrzad; Alipour, Abdolrasool; Edraki, Mitra; Tavakoli, Pouran

    2016-01-01

    Background: Aggression is a kind of behavior that causes damage or harm to others. The prevalence of aggression is 8–20% in 3–6 years old children. The present study aimed to assess the effect of training kindergarten teachers regarding reinforcement behavior therapy on preschoolers’ aggression. Methods: In this cluster randomized control trial, 14 out of 35 kindergarten and preschool centers of Mohr city, Iran, were chosen using random cluster sampling and then randomly assigned to an intervention and a control group. All 370 kindergarten and preschool children in 14 kindergarten were assessed by preschoolers’ aggression questionnaire and 60 children who obtained a minimum aggression score of 117.48 for girls and 125.77 for boys were randomly selected. The teachers in the intervention group participated in 4 educational sessions on behavior therapy and then practiced this technique under the supervision of the researcher for two months. Preschoolers’ aggression questionnaire was computed in both intervention and control groups before and after a two-month period. Results: The results demonstrated a significant statistical difference in the total aggression score (P=0.01), verbal (P=0.02) and physical (P=0.01) aggression subscales scores in the intervention group in comparison to the control group after the intervention. But the scores of relational aggression (P=0.09) and impulsive anger (P=0.08) subscales were not statistically different in the intervention group compared to the controls. Conclusion: This study highlighted the importance of teaching reinforcement behavior therapy by kindergarten teachers in decreasing verbal and physical aggression in preschoolers. Trial Registration Number: IRCT2014042617436N1 PMID:26793733

  10. Occupational risk factors for mycosis fungoides: a European multicenter case-control study.

    PubMed

    Morales-Suárez-Varela, Maria M; Olsen, Jorn; Johansen, Preben; Kaerlev, Linda; Guénel, Pascal; Arveux, Patrick; Wingren, Gun; Hardell, Lennart; Ahrens, Wolfgang; Stang, Andreas; Llopis, Agustin; Merletti, Franco; Aurrekoetxea, Juan Jose; Masala, Giovanna

    2004-03-01

    Mycosis fungoides (MF) is a rare disease with an unknown etiology. Its distribution suggests that occupational exposures may play a role. In the present study, we searched for occupational factors associated with MF. A European multicenter case-control study on seven rare cancers, including MF, was conducted from 1995 to 1997. Patients between 35 and 69 years of age diagnosed with MF (n = 134) were identified and their diagnoses were checked by a reference pathologist who classified 83 cases as definitive, 35 cases as possible, and 16 cases as not histologically verified. Of the 118 histologically verified cases, 104 were interviewed, of which 76 were definitive cases. As controls, we selected population controls and colon cancer controls to serve all seven case groups. Altogether, 833 colon cancer controls and 2071 population controls were interviewed. The response rate was 91.5% for cases (76 of the 83 definitive cases), and 66.6% for controls. A high risk of MF for men was observed in the industries of other non-metallic mineral products (Odds Ratio [OR] 5.3, 95% confidence interval [CI] = 1.7-16.2) and of wholesale trade (OR 3.6, 95% CI = 1.3-10.5). A high risk was found for female employees in the sector of pulp paper manufacture (OR 14.4, 95% CI = 2.2-95.1). The male occupations with the highest risks were glass formers, potters, and ceramics workers (OR 17.9, 95% CI = 5.4-59.4) and technical salesmen (OR 8.6, 95% CI = 2.4-30.8). For women, the occupations associated with the highest risks were government executives (OR 4.8, 95% CI = 1.0-22.6) and railway and road vehicles loaders (OR 3.9, 95% CI = 1.0-14.0). The results suggest that some occupational factors are associated with MF. Working as glass formers, pottery, and ceramics workers carried the highest risk, and these findings deserve further attention and replication. Females working in the paper and pulp industries may also be exposed to carcinogens of relevance to MF.

  11. Key controls of surface carbonate system dynamics around the northwest European continental margin

    NASA Astrophysics Data System (ADS)

    Jiang, Z.; Hydes, D. J.; Hartman, S. E.; Hartman, M. C.

    2011-12-01

    Monthly sampling coupled to continuous underway observation from a ship-of-opportunity (Pride of Bilbao) provides new insights into the relative importance of processes controlling the seasonal to inter-annual variability of the carbonate system around the northwest European continental margin. Total alkalinity (TA) and total dissolved inorganic carbon (DIC) were determined alongside measurements of nutrients and continuous records of temperature, salinity, chlorophyll-fluorescence, and dissolved oxygen (DO). The northwest European continental margin is temperate latitude system with a strong seasonal cycle in biological productivity determined by light, nutrient supply, and stratification. Here we contrast findings in two areas: the shallow non stratified English Channel (depth ~50 m) and seasonally stratified oligotrophic waters of the central Bay of Biscay (depth >3000 m). In the Bay of Biscay, the seasonal variations of the carbonate system, nutrient, and DO were mainly controlled by the winter mixing and spring phytoplankton bloom. DIC and nutrients in the Bay increased from autumn and reached the annual maxima in later winter, they then decreased significantly during the spring bloom corresponding to the biological uptake. DIC fell during the spring bloom with a near Redfield ratio in relation to the nutrient uptake. In contrast, post bloom in summer, a continued decrease in DIC in the absence of measurable nitrate was possibly related to the nutrient supply from the turbulent mixing. pCO2 and pH showed a double peak in the annual cycles modulated by temperature which counterbalanced the influence of winter mixing and biological production. The inter-annual biogeochemical variability was closely related to the changes in winter mixed layer depth and the phytoplankton biomass. The Bay of Biscay acted as a sink for atmospheric CO2 in all seasons, with higher air-to-sea CO2 fluxes observed in cold winter and the productive spring season. In the more dynamic

  12. CR-Calculus and adaptive array theory applied to MIMO random vibration control tests

    NASA Astrophysics Data System (ADS)

    Musella, U.; Manzato, S.; Peeters, B.; Guillaume, P.

    2016-09-01

    Performing Multiple-Input Multiple-Output (MIMO) tests to reproduce the vibration environment in a user-defined number of control points of a unit under test is necessary in applications where a realistic environment replication has to be achieved. MIMO tests require vibration control strategies to calculate the required drive signal vector that gives an acceptable replication of the target. This target is a (complex) vector with magnitude and phase information at the control points for MIMO Sine Control tests while in MIMO Random Control tests, in the most general case, the target is a complete spectral density matrix. The idea behind this work is to tailor a MIMO random vibration control approach that can be generalized to other MIMO tests, e.g. MIMO Sine and MIMO Time Waveform Replication. In this work the approach is to use gradient-based procedures over the complex space, applying the so called CR-Calculus and the adaptive array theory. With this approach it is possible to better control the process performances allowing the step-by-step Jacobian Matrix update. The theoretical bases behind the work are followed by an application of the developed method to a two-exciter two-axis system and by performance comparisons with standard methods.

  13. Speed synchronization control for integrated automotive motor-transmission powertrain system with random delays

    NASA Astrophysics Data System (ADS)

    Zhu, Xiaoyuan; Zhang, Hui; Fang, Zongde

    2015-12-01

    This paper presents a robust speed synchronization controller design for an integrated motor-transmission powertrain system in which the driving motor and multi-gearbox are directly coupled. As the controller area network (CAN) is commonly used in the vehicle powertrain system, the possible network-induced random delays in both feedback and forward channel are considered and modeled by using two Markov chains in the controller design process. For the application perspective, the control law adopted here is a generalized proportional-integral (PI) control. By employing the system-augmentation technique, a delay-free stochastic closed-loop system is obtained and the generalized PI controller design problem is converted to a static output feedback (SOF) controller design problem. Since there are external disturbances involved in the closed-loop system, the energy-to-peak performance is considered to guarantee the robustness of the controller. And the controlled output is chosen as the speed synchronization error. To further improve the transient response of the closed-loop system, the pole placement is also employed in the energy-to-peak performance based speed synchronization control. The mode-dependent control gains are obtained by using an iterative linear matrix inequality (LMI) algorithm. Simulation results show the effectiveness of the proposed control approach.

  14. Prayer and healing: A medical and scientific perspective on randomized controlled trials.

    PubMed

    Andrade, Chittaranjan; Radhakrishnan, Rajiv

    2009-01-01

    Religious traditions across the world display beliefs in healing through prayer. The healing powers of prayer have been examined in triple-blind, randomized controlled trials. We illustrate randomized controlled trials on prayer and healing, with one study in each of different categories of outcome. We provide a critical analysis of the scientific and philosophical dimensions of such research. Prayer has been reported to improve outcomes in human as well as nonhuman species, to have no effect on outcomes, to worsen outcomes and to have retrospective healing effects. For a multitude of reasons, research on the healing effects of prayer is riddled with assumptions, challenges and contradictions that make the subject a scientific and religious minefield. We believe that the research has led nowhere, and that future research, if any, will forever be constrained by the scientific limitations that we outline.

  15. Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study.

    PubMed

    Rogel, Ainat; Guez, Jonathan; Getter, Nir; Keha, Eldad; Cohen, Tzlil; Amor, Tali; Todder, Doron

    2015-09-01

    The benefits of clinical neurofeedback training are well known, however, its adverse side-effects are less studied. This research focuses on the transient adverse side effects of neurofeedback training via a double-blind, sham/controlled methodology. Thirty healthy undergraduate students volunteers were randomly divided into three treatment groups: increasing a modified Sensory Motor Rhythm, increasing Upper Alpha, and Sham/control group who receive a random reward. The training sessions were administered for a total of ten sessions. Questionnaires of transient adverse side effects were completed by all volunteers before each session. The results suggest that similar to most medical treatments, neurofeedback can cause transient adverse side effects. Moreover, most participants reported experiencing some side effects. The side effects can be divided into non-specific side effect, associated with the neurofeedback training in general and specific ones associated with the particular protocol. Sensory Motor Rhythm protocol seems to be the most sensitive to side effects.

  16. ALCOHOLIC VERSUS NONALCOHOLIC CIRRHOSIS IN A RANDOMIZED CONTROLLED TRIAL OF EMERGENCY THERAPY OF BLEEDING VARICES

    PubMed Central

    Orloff, Marshall J.; Isenberg, Jon I.; Wheeler, Henry O.; Haynes, Kevin S.; Jinich-Brook, Horacio; Rapier, Roderick; Vaida, Florin; Hye, Robert J.; Orloff, Susan L.

    2010-01-01

    Background It has been proposed that portal-systemic shunts be avoided in alcoholic cirrhotics because survival rate is allegedly lower in alcoholics than in nonalcoholics. We examined this issue in a randomized controlled trial. Methods 211 unselected, consecutive patients with cirrhosis and bleeding esophageal varices were randomized to endoscopic sclerotherapy (EST) (n=106) or emergency portacaval shunt (EPCS) (105). Treatment was initiated within 8 hours. EST failure was treated by rescue PCS. 10-yr follow-up was 96%. Results Results strongly favored EPCS over EST (p<0.001). Among EPCS patients, 83% were alcoholic and 17% nonalcoholic. Outcomes were (1) permanent control of bleeding 100% vs. 100%; (2) 5-yr survival 71% vs.78%; (3) encephalopathy 14% vs. 19%; (4) yearly charges $38,300 vs. $43,000. Conclusions EPCS results were similar in alcoholic and nonalcoholic cirrhotics. EPCS is an effective first line emergency treatment in all forms of cirrhosis, including alcoholic. PMID:21195430

  17. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

    PubMed Central

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  18. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-07-06

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

  19. Prayer and healing: A medical and scientific perspective on randomized controlled trials

    PubMed Central

    Andrade, Chittaranjan; Radhakrishnan, Rajiv

    2009-01-01

    Religious traditions across the world display beliefs in healing through prayer. The healing powers of prayer have been examined in triple-blind, randomized controlled trials. We illustrate randomized controlled trials on prayer and healing, with one study in each of different categories of outcome. We provide a critical analysis of the scientific and philosophical dimensions of such research. Prayer has been reported to improve outcomes in human as well as nonhuman species, to have no effect on outcomes, to worsen outcomes and to have retrospective healing effects. For a multitude of reasons, research on the healing effects of prayer is riddled with assumptions, challenges and contradictions that make the subject a scientific and religious minefield. We believe that the research has led nowhere, and that future research, if any, will forever be constrained by the scientific limitations that we outline. PMID:20048448

  20. Filtering random matrices: the effect of incomplete channel control in multiple scattering.

    PubMed

    Goetschy, A; Stone, A D

    2013-08-01

    We present an analytic random matrix theory for the effect of incomplete channel control on the measured statistical properties of the scattering matrix of a disordered multiple-scattering medium. When the fraction of the controlled input channels, m1, and output channels, m2, is decreased from unity, the density of the transmission eigenvalues is shown to evolve from the bimodal distribution describing coherent diffusion, to the distribution characteristic of uncorrelated Gaussian random matrices, with a rapid loss of access to the open eigenchannels. The loss of correlation is also reflected in an increase in the information capacity per channel of the medium. Our results have strong implications for optical and microwave experiments on diffusive scattering media. PMID:23971574

  1. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  2. Controlling dispersion forces between small particles with artificially created random light fields

    PubMed Central

    Brügger, Georges; Froufe-Pérez, Luis S.; Scheffold, Frank; José Sáenz, Juan

    2015-01-01

    Appropriate combinations of laser beams can be used to trap and manipulate small particles with optical tweezers as well as to induce significant optical binding forces between particles. These interaction forces are usually strongly anisotropic depending on the interference landscape of the external fields. This is in contrast with the familiar isotropic, translationally invariant, van der Waals and, in general, Casimir–Lifshitz interactions between neutral bodies arising from random electromagnetic waves generated by equilibrium quantum and thermal fluctuations. Here we show, both theoretically and experimentally, that dispersion forces between small colloidal particles can also be induced and controlled using artificially created fluctuating light fields. Using optical tweezers as a gauge, we present experimental evidence for the predicted isotropic attractive interactions between dielectric microspheres induced by laser-generated, random light fields. These light-induced interactions open a path towards the control of translationally invariant interactions with tuneable strength and range in colloidal systems. PMID:26096622

  3. Hospital chaplains' involvement in a randomized controlled multidisciplinary trial: implications for spiritual care and research.

    PubMed

    Piderman, Katherine M; Johnson, Mary E

    2009-01-01

    Chaplains' involvement in spirituality and health research can contribute something vital and unique to these investigations. It can also provide opportunity for professional growth and increased effectiveness. This article describes the authors' experience as co-investigators in a randomized controlled trial involving patients with a life expectancy of less than five years receiving radiation therapy for advanced cancer. It also discusses the application to clinical settings and other research.

  4. Contamination by an Active Control Condition in a Randomized Exercise Trial

    PubMed Central

    Kramer, Arthur F.; McAuley, Edward

    2016-01-01

    Contamination is commonly overlooked in randomized trials. The present study examined contamination (minutes of aerobic activity outside of exercise sessions) within an active control condition in a 6-month randomized exercise trial for older adults. We hypothesized that outside aerobic activity would be greater in the control condition compared to the intervention conditions. Participants (mean age = 65.06 years, 66.2% female) were randomly assigned to: Dance (n = 50), Walking, (n = 108), or Strength/Stretching/Stability (SSS; n = 48). Dance and Walking represented the experimental conditions and SSS the control condition. Participants attended exercise sessions three times weekly for 24 weeks. Participants recorded their physical activity outside of class on a weekly home log. Group assignment and covariates (age, gender, body mass index, exercise session intensity and enjoyment, and program adherence) were examined as predictors of weekly aerobic activity outside of exercise sessions. Participants who returned zero home logs were removed from the dataset (final N = 195). Out-of-class aerobic activity was lowest in the Walking group. Significant effects of gender, group, enjoyment, and intensity on out-of-class weekly aerobic activity were observed, all p<0.003. Higher perceived enjoyment of exercise sessions was associated with more out-of-class aerobic activity, while higher perceived intensity was associated with less out-of-class aerobic activity. A group x intensity interaction, p = 0.002, indicated that group differences in out-of-class aerobic activity were evident only among those with lower intensity perceptions. Walkers may have perceived exercise sessions as sufficient weekly exercise, while the Dance and SSS groups may have perceived the sessions as necessary, but insufficient. The lower aerobic intensity Dancers attributed to exercise sessions and non-aerobic nature of SSS may partially explain contamination observed in this study. Further

  5. Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

    PubMed

    Holman, Andrew J

    2008-12-01

    A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

  6. A systematic mapping review of Randomized Controlled Trials (RCTs) in care homes

    PubMed Central

    2012-01-01

    Background A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to describe the extent of the evidence base derived from randomized controlled trials conducted in care homes. Methods A systematic mapping review was conducted of the randomized controlled trials (RCTs) conducted in care homes. Medline was searched for “Nursing Home”, “Residential Facilities” and “Homes for the Aged”; CINAHL for “nursing homes”, “residential facilities” and “skilled nursing facilities”; AMED for “Nursing homes”, “Long term care”, “Residential facilities” and “Randomized controlled trial”; and BNI for “Nursing Homes”, “Residential Care” and “Long-term care”. Articles were classified against a keywording strategy describing: year and country of publication; randomization, stratification and blinding methodology; target of intervention; intervention and control treatments; number of subjects and/or clusters; outcome measures; and results. Results 3226 abstracts were identified and 291 articles reviewed in full. Most were recent (median age 6 years) and from the United States. A wide range of targets and interventions were identified. Studies were mostly functional (44 behaviour, 20 prescribing and 20 malnutrition studies) rather than disease-based. Over a quarter focussed on mental health. Conclusions This study is the first to collate data from all RCTs conducted in care homes and represents an important resource for those providing and commissioning healthcare for this sector. The evidence-base is rapidly developing. Several areas - influenza, falls, mobility, fractures, osteoporosis – are appropriate for systematic review. For other topics, researchers need to focus on outcome measures that can be compared and collated. PMID:22731652

  7. Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

    PubMed Central

    Kraemer, Helena C.; Epstein, Robert S.; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P.; Mcnulty, James; Reed, Shelby D.; Sanchez, Juan; Leon, Andrew C.

    2013-01-01

    Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. PMID:23882433

  8. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial.

    PubMed

    Schmidt, Stefan; Grossman, Paul; Schwarzer, Barbara; Jena, Susanne; Naumann, Johannes; Walach, Harald

    2011-02-01

    Mindfulness-based stress reduction (MBSR) is a structured 8-week group program teaching mindfulness meditation and mindful yoga exercises. MBSR aims to help participants develop nonjudgmental awareness of moment-to-moment experience. Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and insomnia as major symptoms. Efficacy of MBSR for enhanced well-being of fibromyalgia patients was investigated in a 3-armed trial, which was a follow-up to an earlier quasi-randomized investigation. A total of 177 female patients were randomized to one of the following: (1) MBSR, (2) an active control procedure controlling for nonspecific effects of MBSR, or (3) a wait list. The major outcome was health-related quality of life (HRQoL) 2 months post-treatment. Secondary outcomes were disorder-specific quality of life, depression, pain, anxiety, somatic complaints, and a proposed index of mindfulness. Of the patients, 82% completed the study. There were no significant differences between groups on primary outcome, but patients overall improved in HRQoL at short-term follow-up (P=0.004). Post hoc analyses showed that only MBSR manifested a significant pre-to-post-intervention improvement in HRQoL (P=0.02). Furthermore, multivariate analysis of secondary measures indicated modest benefits for MBSR patients. MBSR yielded significant pre-to-post-intervention improvements in 6 of 8 secondary outcome variables, the active control in 3, and the wait list in 2. In conclusion, primary outcome analyses did not support the efficacy of MBSR in fibromyalgia, although patients in the MBSR arm appeared to benefit most. Effect sizes were small compared to the earlier, quasi-randomized investigation. Several methodological aspects are discussed, e.g., patient burden, treatment preference and motivation, that may provide explanations for differences. In a 3-armed randomized controlled trial in female patients suffering from fibromyalgia, patients benefited modestly from a mindfulness

  9. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... HUMAN SERVICES Food and Drug Administration Meta-Analyses of Randomized Controlled Clinical Trials (RCTs... constructive discussion and information-sharing about best practices in meta-analyses of clinical trial data... scientific approaches for the conduct and assessment of meta-analyses of randomized controlled...

  10. A Randomized Controlled Trial Evaluation of an After-School Prosocial Behavior Program in an Area of Socioeconomic Disadvantage

    ERIC Educational Resources Information Center

    O'Hare, Liam; Biggart, Andy; Kerr, Karen; Connolly, Paul

    2015-01-01

    A randomized controlled trial was used to evaluate the effects of a prosocial behavior after-school program called Mate-Tricks for 9- and 10-year-old children and their parents living in an area of significant socioeconomic disadvantage. The children were randomly assigned to an intervention (n = 220) or a control group (n = 198). Children were…

  11. The Effects of School Gardens on Children's Science Knowledge: A Randomized Controlled Trial of Low-Income Elementary Schools

    ERIC Educational Resources Information Center

    Wells, Nancy M.; Myers, Beth M.; Todd, Lauren E.; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Henderson, Charles R.; Tse, Caroline; Pattison, Karen Ostlie; Taylor, Cayla; Connerly, Laura; Carson, Janet B.; Gensemer, Alexandra Z.; Franz, Nancy K.; Falk, Elizabeth

    2015-01-01

    This randomized controlled trial or "true experiment" examines the effects of a school garden intervention on the science knowledge of elementary school children. Schools were randomly assigned to a group that received the garden intervention (n?=?25) or to a waitlist control group that received the garden intervention at the end of the…

  12. Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

    PubMed

    Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

    2014-05-01

    Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work.

  13. Effectiveness of sensorimotor training in patients with rheumatoid arthritis: a randomized controlled trial.

    PubMed

    da Silva, Kelson Nonato Gomes; Teixeira, Lucas Emmanuel Pedro de Paiva; Imoto, Aline Mizusaki; Atallah, Alvaro Nagib; Peccin, Maria Stella; Trevisani, Virginia Fernandes Moça

    2013-09-01

    The objective of this study was to evaluate the effectiveness of a sensorimotor training in patients with rheumatoid arthritis on the improvement of functional skills and quality of life, a double-blinded, prospective, randomized controlled trial. One hundred two participants with rheumatoid arthritis were selected. After the baseline evaluation, the participants were randomized to two different groups: sensorimotor group (2 sessions per week, 30-50 min each session, besides continuing taking the same drugs as the control group) and control group (control group was only submitted to the clinical drug treatment with Methotrexate, Leflunomide and/or Prednisone (5 mg), being then evaluated 4 months later). Functional capacity [Health Assessment Questionnaire (HAQ) and Timed Up & Go Test (TU>)], Balance and Gait (Berg Balance Scale (BBS) and Tinetti Test) and Quality of Life (Short Form Health Survey-SF-36). The study had been concluded with ninety-one participants, and a statistically significant improvement was found in all variables assessed: HAQ (P < .01), TU> (P < .01), BBS (P < .01), Tinetti Test (P < .01) and improvement in the subscales of SF-36 (P < .01) in the sensorimotor group in comparison with the baseline evaluation and control group. No significant difference was found related to the pre- and post-evaluation in the control group. Therefore, the sensorimotor training is effective in the improvement of the functional capacity and quality of life of patients with rheumatoid arthritis.

  14. Effects of vacuum-compression therapy on healing of diabetic foot ulcers: randomized controlled trial.

    PubMed

    Akbari, Asghar; Moodi, Hesam; Ghiasi, Fatemeh; Sagheb, Hamidreza Mahmoudzadeh; Rashidi, Homayra

    2007-01-01

    A single-blind, randomized controlled trial was conducted to evaluate vacuum-compression therapy (VCT) for the healing of diabetic foot ulcers. Eighteen diabetic patients with foot ulcers were recruited through simple nonprobability sampling. Subjects were randomly assigned to either an experimental or a control group. Before and after intervention, the foot ulcer surface area was estimated stereologically, based on Cavalieri's principle. The experimental group was treated with VCT in addition to conventional therapy for 10 sessions. The control group received only conventional therapy, including debridement, blood glucose control agents, systemic antibiotics, wound cleaning with normal saline, offloading (pressure relief), and daily wound dressings. The mean foot ulcer surface area decreased from 46.88 +/- 9.28 mm(2) to 35.09 +/- 4.09 mm(2) in the experimental group (p = 0.006) and from 46.62 +/- 10.03 mm(2) to 42.89 +/- 8.1 mm(2) in the control group (p = 0.01). After treatment, the experimental group significantly improved in measures of foot ulcer surface area compared with the control group (p = 0.024). VCT enhances diabetic foot ulcer healing when combined with appropriate wound care.

  15. An Eight Month Randomized Controlled Exercise Intervention Alters Resting State Synchrony in Overweight Children

    PubMed Central

    Krafft, Cynthia E.; Pierce, Jordan E.; Schwarz, Nicolette F.; Chi, Lingxi; Weinberger, Abby L.; Schaeffer, David J.; Rodrigue, Amanda L.; Camchong, Jazmin; Allison, Jerry D.; Yanasak, Nathan E.; Liu, Tianming; Davis, Catherine L.; McDowell, Jennifer E.

    2014-01-01

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥ 85th percentile) children 8–11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children. PMID:24096138

  16. Reliable H∞ control of discrete-time systems against random intermittent faults

    NASA Astrophysics Data System (ADS)

    Tao, Yuan; Shen, Dong; Fang, Mengqi; Wang, Youqing

    2016-07-01

    A passive fault-tolerant control strategy is proposed for systems subject to a novel kind of intermittent fault, which is described by a Bernoulli distributed random variable. Three cases of fault location are considered, namely, sensor fault, actuator fault, and both sensor and actuator faults. The dynamic feedback controllers are designed not only to stabilise the fault-free system, but also to guarantee an acceptable performance of the faulty system. The robust H∞ performance index is used to evaluate the effectiveness of the proposed control scheme. In terms of linear matrix inequality, the sufficient conditions of the existence of controllers are given. An illustrative example indicates the effectiveness of the proposed fault-tolerant control method.

  17. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A.; Robinson, John W. . E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S.; Keats, Melanie R.

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  18. The Control of Autumn Senescence in European Aspen1[W][OA

    PubMed Central

    Fracheboud, Yvan; Luquez, Virginia; Björkén, Lars; Sjödin, Andreas; Tuominen, Hannele; Jansson, Stefan

    2009-01-01

    The initiation, progression, and natural variation of autumn senescence in European aspen (Populus tremula) was investigated by monitoring chlorophyll degradation in (1) trees growing in natural stands and (2) cloned trees growing in a greenhouse under various light regimes. The main trigger for the initiation of autumn senescence in aspen is the shortening photoperiod, but there was a large degree of variation in the onset of senescence, both within local populations and among trees originating from different populations, where it correlated with the latitude of their respective origins. The variation for onset of senescence with a population was much larger than the variation of bud set. Once started, autumn senescence was accelerated by low temperature and longer nights, and clones that started to senescence late had a faster senescence. Bud set and autumn senescence appeared to be under the control of two independent critical photoperiods, but senescence could not be initiated until a certain time after bud set, suggesting that bud set and growth arrest are important for the trees to acquire competence to respond to the photoperiodic trigger to undergo autumn senescence. A timetable of events related to bud set and autumn senescence is presented. PMID:19201914

  19. Approaches for controlling illicit tobacco trade--nine countries and the European Union.

    PubMed

    Ross, Hana; Husain, Muhammad Jami; Kostova, Deliana; Xu, Xin; Edwards, Sarah M; Chaloupka, Frank J; Ahluwalia, Indu B

    2015-05-29

    An estimated 11.6% of the world cigarette market is illicit, representing more than 650 billion cigarettes a year and $40.5 billion in lost revenue. Illicit tobacco trade refers to any practice related to distributing, selling, or buying tobacco products that is prohibited by law, including tax evasion (sale of tobacco products without payment of applicable taxes), counterfeiting, disguising the origin of products, and smuggling. Illicit trade undermines tobacco prevention and control initiatives by increasing the accessibility and affordability of tobacco products, and reduces government tax revenue streams. The World Health Organization (WHO) Protocol to Eliminate Illicit Trade in Tobacco Products, signed by 54 countries, provides tools for addressing illicit trade through a package of regulatory and governing principles. As of May 2015, only eight countries had ratified or acceded to the illicit trade protocol, with an additional 32 needed for it to become international law (i.e., legally binding). Data from multiple international sources were analyzed to evaluate the 10 most commonly used approaches for addressing illicit trade and to summarize differences in implementation across select countries and the European Union (EU). Although the WHO illicit trade protocol defines shared global standards for addressing illicit trade, countries are guided by their own legal and enforcement frameworks, leading to a diversity of approaches employed across countries. Continued adoption of the methods outlined in the WHO illicit trade protocol might improve the global capacity to reduce illicit trade in tobacco products.

  20. Approaches for controlling illicit tobacco trade--nine countries and the European Union.

    PubMed

    Ross, Hana; Husain, Muhammad Jami; Kostova, Deliana; Xu, Xin; Edwards, Sarah M; Chaloupka, Frank J; Ahluwalia, Indu B

    2015-05-29

    An estimated 11.6% of the world cigarette market is illicit, representing more than 650 billion cigarettes a year and $40.5 billion in lost revenue. Illicit tobacco trade refers to any practice related to distributing, selling, or buying tobacco products that is prohibited by law, including tax evasion (sale of tobacco products without payment of applicable taxes), counterfeiting, disguising the origin of products, and smuggling. Illicit trade undermines tobacco prevention and control initiatives by increasing the accessibility and affordability of tobacco products, and reduces government tax revenue streams. The World Health Organization (WHO) Protocol to Eliminate Illicit Trade in Tobacco Products, signed by 54 countries, provides tools for addressing illicit trade through a package of regulatory and governing principles. As of May 2015, only eight countries had ratified or acceded to the illicit trade protocol, with an additional 32 needed for it to become international law (i.e., legally binding). Data from multiple international sources were analyzed to evaluate the 10 most commonly used approaches for addressing illicit trade and to summarize differences in implementation across select countries and the European Union (EU). Although the WHO illicit trade protocol defines shared global standards for addressing illicit trade, countries are guided by their own legal and enforcement frameworks, leading to a diversity of approaches employed across countries. Continued adoption of the methods outlined in the WHO illicit trade protocol might improve the global capacity to reduce illicit trade in tobacco products. PMID:26020137

  1. Impact of Tobacco Control Policy on Quitting and Nicotine Dependence among Women in Five European Countries

    PubMed Central

    Allen, JA; Gritz, ER; Xiao, H; Rubenstein, R; Kralikova, Eva; Haglund, Margaretha; Heck, JE; Niaura, R; Vallone, DM

    2014-01-01

    Objective Describe differences in and factors associated with former smoking and nicotine dependence among women in Ireland, Sweden, France, Italy and the Czech Republic. Methods A cross-sectional, random digit dial telephone survey of 5000 women, ages 18 and older, conducted in 2008. Analyses were conducted using logistic regression models. Results Respondents from Ireland and Sweden had statistically significantly higher odds of having quit smoking within the 5 years prior to survey administration as compared with respondents from the Czech Republic. Current smokers from Ireland, Sweden, France and Italy are more nicotine dependent than those from the Czech Republic. Conclusions Respondents from countries with stronger tobacco control policies were more likely to be have quit smoking compared with those living in the Czech Republic. However, respondents in countries with some of the strongest policies (Ireland, Sweden, France and Italy) had higher odds of smoking within 30 minutes of waking, an established indicator of nicotine dependence. More research in this area is warranted, but this study suggests that: 1) now that the Czech Republic is beginning to implement strong tobacco control policy, they will likely achieve a rapid decline in population-level smoking; and 2) Ireland, Sweden, France, Italy and other countries with established, strong tobacco control policies would do well to consider what additional programs they can put in place to help their highly nicotine dependent population of smokers successfully quit. PMID:23152098

  2. Educational interventions to improve screening mammography interpretation: a randomized, controlled trial

    PubMed Central

    BM, Geller; A, Bogart; PA, Carney; EA, Sickles; RA, Smith; B, Monsees; LW, Bassett; DM, Buist; K, Kerlikowske; T, Onega; B, Yankaskas; S, Haneuse; DA, Hill; M, Wallis; DL, Miglioretti

    2014-01-01

    Purpose Conduct a randomized controlled trial of educational interventions to improve performance of screening mammography interpretation. Materials and Methods We randomly assigned physicians who interpret mammography to one of three groups: (1) self-paced DVD; (2) live, expert-led educational session; or (3) control. The DVD and live interventions used mammography cases of varying difficulty and associated teaching points. Interpretive performance was compared using a pre-/post-test design. Sensitivity, specificity, and positive predictive value (PPV) were calculated relative to two outcomes: cancer status and consensus of three experts about recall, and each were compared using logistic regression adjusting for pre-test performance. Results 102 radiologists completed all aspects of the trial. After adjustment for pre-intervention performance, the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than controls (95% confidence interval [CI]: 1.00, 1.81; P=0.050). The odds of improved PPV for correctly identifying a lesion relative to both expert recall (odds ratio [OR]=1.94, 95% CI: 1.24, 3.05; P=0.004) and cancer status (OR=1.81, 95% CI: 1.01, 3.23; P=0.045) were significantly improved for DVD participants compared to controls with no significant change in specificity. For the live-intervention group, specificity was significantly lower than the control group (OR relative to expert recall=0.80; 95% CI: 0.64, 1.00; P=0.048; OR relative to cancer=0.79; 95% CI: 0.65, 0.95; P=0.015). Conclusion In this randomized controlled trial, the DVD educational intervention resulted in a significant improvement in mammography interpretive screening performance on a test-set, which could translate into improved clinical interpretative performance. PMID:24848854

  3. Humour-related interventions for people with mental illness: a randomized controlled pilot study.

    PubMed

    Rudnick, Abraham; Kohn, Paul M; Edwards, Kim R; Podnar, David; Caird, Sara; Martin, Rod

    2014-08-01

    This study explored the feasibility and effects of humour-related interventions for mentally ill adults. Twelve, randomly assigned, participated in each of 3 arms--stand up comedy training (the experimental arm), discussing comedy videos (the active control arm), and no humour-related intervention (the passive control arm). Quantitative and qualitative data were collected at baseline, end of interventions (3 months) and follow up (after another 3 months). Scale comparisons were largely negative, although self-esteem marginally increased in the experimental arm. Interview responses indicated benefits for the interventions, including improved self-esteem in the experimental arm. These results, though mixed, justify further study.

  4. A Prospective Randomized Controlled Trial of an Interpersonal Violence Prevention Program With a Mexican American Community

    PubMed Central

    Kelly, Patricia J.; Lesser, Janna; Cheng, An-Lin; Osóos-Sánchez, Manuel; Martinez, Elisabeth; Pineda, Daniel; Mancha, Juan

    2014-01-01

    Using methods of community-based participatory research, a prospective randomized controlled trial of a violence prevention program based on Latino cultural values was implemented with elementary school children in a Mexican American community. Community members participated in intervention program selection, implementation, and data collection. High-risk students who participated in the program had greater nonviolent self-efficacy and demonstrated greater endorsement of program values than did high-risk students in the control group. This collaborative partnership was able to combine community-based participatory research with a rigorous study design and provide sustained benefit to community partners. PMID:20531101

  5. A Chinese Mind-Body Exercise Improves Self-Control of Children with Autism: A Randomized Controlled Trial

    PubMed Central

    Chan, Agnes S.; Sze, Sophia L.; Siu, Nicolson Y.; Lau, Eliza M.; Cheung, Mei-chun

    2013-01-01

    Self-control problems commonly manifest as temper outbursts and repetitive/rigid/impulsive behaviors, in children with autism spectrum disorders (ASD), which often contributes to learning difficulties and caregiver burden. The present study aims to compare the effect of a traditional Chinese Chan-based mind-body exercise, Nei Yang Gong, with that of the conventional Progressive Muscle Relaxation (PMR) technique in enhancing the self-control of children with ASD. Forty-six age- and IQ-matched ASD children were randomly assigned to receive group training in Nei Yang Gong (experimental group) or PMR (control group) twice per week for four weeks. The participants’ self-control was measured by three neuropsychological tests and parental rating on standardized questionnaires, and the underlying neural mechanism was assessed by the participants’ brain EEG activity during an inhibitory-control task before and after intervention. The results show that the experimental group demonstrated significantly greater improvement in self-control than the control group, which concurs with the parental reports of reduced autistic symptoms and increased control of temper and behaviors. In addition, the experimental group showed enhanced EEG activity in the anterior cingulate cortex, a region that mediates self-control, whereas the PMR group did not. The present findings support the potential application of Chinese Chan-based mind-body exercises as a form of neuropsychological rehabilitation for patients with self-control problems. Chinese Clinical Trial Registry; Registration No.: ChiCTR-TRC-12002561; URL: www.chictr.org. PMID:23874533

  6. Psychoanalytic and cognitive-behavior therapy of chronic depression: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Despite limited effectiveness of short-term psychotherapy for chronic depression, there is a lack of trials of long-term psychotherapy. Our study is the first to determine the effectiveness of controlled long-term psychodynamic and cognitive-behavioral (CBT) treatments and to assess the effects of preferential vs. randomized assessment. Methods/design Patients are assigned to treatment according to their preference or randomized (if they have no clear preference). Up to 80 sessions of psychodynamic or psychoanalytically oriented treatments (PAT) or up to 60 sessions of CBT are offered during the first year in the study. After the first year, PAT can be continued according to the ‘naturalistic’ usual method of treating such patients within the system of German health care (normally from 240 up to 300 sessions over two to three years). CBT therapists may extend their treatment up to 80 sessions, but focus mainly maintenance and relapse prevention. We plan to recruit a total of 240 patients (60 per arm). A total of 11 assessments are conducted throughout treatment and up to three years after initiation of treatment. The primary outcome measures are the Quick Inventory of Depressive Symptoms (QIDS, independent clinician rating) and the Beck Depression Inventory (BDI) after the first year. Discussion We combine a naturalistic approach with randomized controlled trials(RCTs)to investigate how effectively chronic depression can be treated on an outpatient basis by the two forms of treatment reimbursed in the German healthcare system and we will determine the effects of treatment preference vs. randomization. Trial registration http://www.controlled-trials.com/ISRCTN91956346 PMID:22834725

  7. Asthma control and hospitalizations among inner-city children: results of a randomized trial.

    PubMed

    Guendelman, Sylvia; Meade, Kelley; Chen, Ying Qing; Benson, Mindy

    2004-01-01

    Asthma prevalence is increasing among poor and minority children. We examined the effectiveness of a novel interactive device programmed for self-management of pediatric asthma in reducing asthma control problems and hospitalizations. A randomized controlled trial (66 children in the intervention group and 68 in the control group) was conducted at home and in an outpatient hospital clinic with 8-16-year-old inner-city children with physician-diagnosed asthma. During a 12-week period, children in the experimental group received an asthma self-management and education program, the Health Buddy (Health Hero Network), designed to enable them to monitor their symptoms and transmit this information to a case manager through a secure website. Control group participants used an asthma diary. After adjusting for baseline asthma control problems, asthma severity, and seasonality, children randomized to automated self-management had a significantly lower mean number of asthma control problems at 6 weeks (2.0, SD = 1.6) as compared to children assigned to the asthma diary (2.7, SD = 1.6) (p = 0.03). By 12 weeks, after adjusting for time and the other covariates, asthma control problems dropped markedly in both groups, and did not differ by intervention modality (p = .07). The intervention modality was not a significant predictor of hospitalization. Educational interventions that encourage children's active involvement in their own care and symptom monitoring would help children increase their control of asthma problems. Compared to the asthma diary, the automated self-management had a significant short-term impact on asthma control problems. Its initial effectiveness and more consistent use suggest that remote monitoring may be successfully used in short-term interventions and in settings where staffing for case management is weak.

  8. A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program

    PubMed Central

    2016-01-01

    Objectives. To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. Methods. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. Results. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. Conclusions. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use. PMID:27689502

  9. Effects of Natural Sounds on Pain: A Randomized Controlled Trial with Patients Receiving Mechanical Ventilation Support.

    PubMed

    Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Vaismoradi, Mojtaba; Jordan, Sue

    2015-08-01

    Nonpharmacologic pain management in patients receiving mechanical ventilation support in critical care units is under investigated. Natural sounds may help reduce the potentially harmful effects of anxiety and pain in hospitalized patients. The aim of this study was to examine the effect of pleasant, natural sounds on self-reported pain in patients receiving mechanical ventilation support, using a pragmatic parallel-arm, randomized controlled trial. The study was conducted in a general adult intensive care unit of a high-turnover teaching hospital, in Tehran, Iran. Between October 2011 and June 2012, we recruited 60 patients receiving mechanical ventilation support to the intervention (n = 30) and control arms (n = 30) of a pragmatic parallel-group, randomized controlled trial. Participants in both arms wore headphones for 90 minutes. Those in the intervention arm heard pleasant, natural sounds, whereas those in the control arm heard nothing. Outcome measures included the self-reported visual analog scale for pain at baseline; 30, 60, and 90 minutes into the intervention; and 30 minutes post-intervention. All patients approached agreed to participate. The trial arms were similar at baseline. Pain scores in the intervention arm fell and were significantly lower than in the control arm at each time point (p < .05). Administration of pleasant, natural sounds via headphones is a simple, safe, nonpharmacologic nursing intervention that may be used to allay pain for up to 120 minutes in patients receiving mechanical ventilation support.

  10. Compensation method for random drifts of laser beams based on moving average feedback control

    NASA Astrophysics Data System (ADS)

    Zhang, Lixia; Wang, Ruilin; Lin, Wumei; Liao, Zhijie

    2012-10-01

    In order to eliminate the measurement errors caused by the instability of laser beams, a real-time compensation algorithms for the random drifts of laser beams based on moving average (MA) correction mechanism was presented. By establishing a correction model with two fast steering mirrors in the beam delivery path and analyzing the pulse to pulse beam fluctuation, a real-time beam drifts correction is implemented based on closed loop feedback control, which especially focuses on reducing the pulse to pulse drifts and ground fluctuations. The simulation results show that this algorithm can control beam drifts effectively. Optimal MA can be reduced to 3n-1/2 times (n--pulse numbers in a window) without the ground vibrations. There are a series of improvements on the moving standard deviation (MSD) as well. MSD get a sudden decline at the window pulse. Meanwhile, the drifts can be restrained while loading the ground vibrations without any big jump, and the dropping amplitude is bigger than without the ground vibration. MSD drop while the whole system is controlled by this compensation method and the results are stable. The key of this compensation method for random drifts of laser beams based on moving average feedback control lies in the appropriate corrections formula. What is more, this algorithm which is practical can achieve high precision control of direction drifts.

  11. Olive Oil Polyphenols Decrease LDL Concentrations and LDL Atherogenicity in Men in a Randomized Controlled Trial123

    PubMed Central

    Hernáez, Álvaro; Remaley, Alan T; Farràs, Marta; Fernández-Castillejo, Sara; Subirana, Isaac; Schröder, Helmut; Fernández-Mampel, Mireia; Muñoz-Aguayo, Daniel; Sampson, Maureen; Solà, Rosa; Farré, Magí; de la Torre, Rafael; López-Sabater, María-Carmen; Nyyssönen, Kristiina; Zunft, Hans-Joachim F; Covas, María-Isabel; Fitó, Montserrat

    2015-01-01

    Background: Olive oil polyphenols have shown protective effects on cardiovascular risk factors. Their consumption decreased oxidative stress biomarkers and improved some features of the lipid profile. However, their effects on LDL concentrations in plasma and LDL atherogenicity have not yet been elucidated. Objective: Our objective was to assess whether the consumption of olive oil polyphenols could decrease LDL concentrations [measured as apolipoprotein B-100 (apo B-100) concentrations and the total number of LDL particles] and atherogenicity (the number of small LDL particles and LDL oxidizability) in humans. Methods: The study was a randomized, cross-over controlled trial in 25 healthy European men, aged 20–59 y, in the context of the EUROLIVE (Effect of Olive Oil Consumption on Oxidative Damage in European Populations) study. Volunteers ingested 25 mL/d raw low-polyphenol-content olive oil (LPCOO; 366 mg/kg) or high-polyphenol-content olive oil (HPCOO; 2.7 mg/kg) for 3 wk. Interventions were preceded by 2-wk washout periods. Effects of olive oil polyphenols on plasma LDL concentrations and atherogenicity were determined in the sample of 25 men. Effects on lipoprotein lipase (LPL) gene expression were assessed in another sample of 18 men from the EUROLIVE study. Results: Plasma apo B-100 concentrations and the number of total and small LDL particles decreased (mean ± SD: by 5.94% ± 16.6%, 11.9% ± 12.0%, and 15.3% ± 35.1%, respectively) from baseline after the HPCOO intervention. These changes differed significantly from those after the LPCOO intervention, which resulted in significant increases of 6.39% ± 16.6%, 4.73% ± 22.0%, and 13.6% ± 36.4% from baseline (P < 0.03). LDL oxidation lag time increased by 5.0% ± 10.3% from baseline after the HPCOO intervention, which was significantly different only relative to preintervention values (P = 0.038). LPL gene expression tended to increase by 26% from baseline after the HPCOO intervention (P = 0.08) and did

  12. Trends in the methodological quality of published randomized controlled trials on antibacterial agents

    PubMed Central

    Falagas, Matthew E; Pitsouni, Eleni I; Bliziotis, Ioannis A

    2008-01-01

    AIM To investigate the trends of the methodological quality of randomized controlled trials (RCTs) of antimicrobial agents published during the last 30 years. METHODS We randomly selected from the Cochrane Central Register of Controlled Trials database 70 RCTs of antibacterial agents that were published during a 30-year study period (1975–2005); specifically, we randomly selected 10 RCTs published during each of the following years: 1975, 1980, 1985, 1990, 1995, 2000 and 2005. In each of the selected RCTs, we searched for information on various methodological aspects and graded the methodological quality of the RCTs to evaluate trends for possible improvement. RESULTS No improvement was noted in most of the analysed methodological aspects of the RCTs during the 30-year study period. Description of randomization, double blinding, description of the blinding, and allocation concealment were rather scarce among the evaluated RCTs, without observing a trend for improvement during the study period. We noted improvement in reporting power of the study calculations, baseline data as well as in reporting the presence or not of statistical significance and the statistical cut-off of significance. In only 1/70 RCTs were all 13 of the examined methodological quality aspects met and in one more RCT 12 of them were met. CONCLUSIONS We did not observe considerable improvement in the quality of the reporting and methodology of RCTs on antibacterial agents during the last 30 years. The methodological quality aspects that need most improvement are those that help safeguard against various types of biases. WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT Randomized controlled trials (RCTs) are believed to be one of the best methods of clinical research because they can minimize systematic errors of various types. Temporal trends in the various aspects of RCTs have been studied in several medical fields (e.g. nephrology, hepatology, oncology). However, there is lack of data regarding the

  13. Massage Therapy for Patients with Metastatic Cancer: A Pilot Randomized Controlled Trial

    PubMed Central

    Toth, Maria; Marcantonio, Edward R.; Davis, Roger B.; Walton, Tracy; Kahn, Janet R.

    2013-01-01

    Abstract Objectives The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. Design This was a randomized controlled trial. Settings/location Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects Subjects were patients with metastatic cancer. Interventions There were three interventions: massage therapy, no-touch intervention, and usual care. Outcome measures Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. Results In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. Conclusions The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings. PMID:23368724

  14. VHR image region-based classification potential in the framework of the control with remote sensing of the European CAP

    NASA Astrophysics Data System (ADS)

    Carleer, Alexandre P.; Wolff, Eléonore

    2005-10-01

    In the framework of the European CAP (Common Agricultural Policy), the European Commission imposes on member states to prevent irregularities, and recommends the control with remote sensing (CwRS) of the declared crops and declared area of crop fields. In the framework of remote sensing procedure, the European Commission, by the way of his Joint Research Centre, advises the use of very high spatial resolution (VHR) satellite data. These data are extraordinary from the point of view of the spatial resolution but the use of these kinds of data involves some problems in the traditional per-pixel classification like the salt and pepper effect and the poor spectral resolution of the VHR data. The region-based classification could solve these problems and allows the use of other features on top of spectral features in the classification process. This study present the potential of the VHR data region-based classification to the classification of the agricultural and rural land cover in the framework of the remote sensing control of the European Union CAP.

  15. Assessment of heterogeneity between European Populations: a Baltic and Danish replication case-control study of SNPs from a recent European ulcerative colitis genome wide association study

    PubMed Central

    2011-01-01

    Background Differences in the genetic architecture of inflammatory bowel disease between different European countries and ethnicities have previously been reported. In the present study, we wanted to assess the role of 11 newly identified UC risk variants, derived from a recent European UC genome wide association study (GWAS) (Franke et al., 2010), for 1) association with UC in the Nordic countries, 2) for population heterogeneity between the Nordic countries and the rest of Europe, and, 3) eventually, to drive some of the previous findings towards overall genome-wide significance. Methods Eleven SNPs were replicated in a Danish sample consisting of 560 UC patients and 796 controls and nine missing SNPs of the German GWAS study were successfully genotyped in the Baltic sample comprising 441 UC cases and 1156 controls. The independent replication data was then jointly analysed with the original data and systematic comparisons of the findings between ethnicities were made. Pearson's χ2, Breslow-Day (BD) and Cochran-Mantel-Haenszel (CMH) tests were used for association analyses and heterogeneity testing. Results The rs5771069 (IL17REL) SNP was not associated with UC in the Danish panel. The rs5771069 (IL17REL) SNP was significantly associated with UC in the combined Baltic, Danish and Norwegian UC study sample driven by the Norwegian panel (OR = 0.89, 95% CI: 0.79-0.98, P = 0.02). No association was found between rs7809799 (SMURF1/KPNA7) and UC (OR = 1.20, 95% CI: 0.95-1.52, P = 0.10) or between UC and all other remaining SNPs. We had 94% chance of detecting an association for rs7809799 (SMURF1/KPNA7) in the combined replication sample, whereas the power were 55% or lower for the remaining SNPs. Statistically significant PBD was found for OR heterogeneity between the combined Baltic, Danish, and Norwegian panel versus the combined German, British, Belgian, and Greek panel (rs7520292 (P = 0.001), rs12518307 (P = 0.007), and rs2395609 (TCP11) (P = 0.01), respectively

  16. A postdeployment expressive writing intervention for military couples: a randomized controlled trial.

    PubMed

    Baddeley, Jenna L; Pennebaker, James W

    2011-10-01

    The current study tested the effectiveness of a brief expressive writing intervention on the marital adjustment of 102 military couples recently reunited following a deployment to Iraq or Afghanistan. Active duty soldiers and their spouses were randomly assigned to write about either their relationship or a nonemotional topic on 3 occasions on a single day. The resulting design included 4 couple-level writing topic conditions: soldier-expressive/spouse-expressive, soldier-expressive/spouse-control, soldier-control/spouse-expressive, and soldier-control/spouse-control. Participants completed marital adjustment measures before writing, 1 month, and 6 months after writing. When soldiers, but not spouses, did expressive writing, couples increased in marital satisfaction over the next month, particularly if the soldier had had high combat exposure.

  17. Randomized-Control Screening Trials to Lower Gall Bladder Cancer Mortality in High Risk Populations.

    PubMed

    Krishnatreya, Manigreeva; Kataki, Amal Chandra

    2016-01-01

    Gall bladder cancer is generally fatal. The high morbidity and mortality due to gall bladder cancer exerts a significant impact on efforts towards cancer control in high risk populations of the World and a rationale program for control of gall bladder cancer mortality has remained as an unmet need in these populations. Currently there are no effective strategies for controlling gall bladder cancer mortality. This mini review is to highlight the need and feasibility for secondary prevention of gall bladder cancer by screening in high risk populations. A way forward is to assess the role of secondary prevention of gall bladder cancers by conducting randomized- controlled screening trials in high risk populations. PMID:27221939

  18. Bedside charting of pain levels in hospitalized patients with cancer: a randomized controlled trial.

    PubMed

    Kravitz, R L; Delafield, J P; Hays, R D; Drazin, R; Conolly, M

    1996-02-01

    Despite advances in the technology of cancer pain assessment and control, cancer pain often remains undertreated even in hospital settings. To determine whether a graphical display of cancer patients' pain levels might improve their treatment, the investigators conducted a randomized controlled trial. Patients assigned to the intervention group (N = 40) had periodic pain assessments by study staff, who graphically recorded their reported pain-intensity levels on bedside wall charts. Control group patients (N = 38) had periodic pain assessments by study staff but did not have this information displayed. The results failed to show a significant beneficial effect of the intervention on pain control, sleep, cancer-related symptoms, or analgesic dosing, but confidence intervals were broad. More research is needed to improve the quality of care for inpatients with cancer-related pain. PMID:8907138

  19. Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

    PubMed Central

    2011-01-01

    Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI) from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010 PMID:21388554

  20. The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Cramer, Holger; Ward, Lesley; Saper, Robert; Fishbein, Daniel; Dobos, Gustav; Lauche, Romy

    2015-08-15

    As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P < 0.01) occurred in the yoga group; serious adverse events and dropouts due to adverse events were comparable between groups. Findings from this review indicate that yoga appears as safe as usual care and exercise. The adequate reporting of safety data in future randomized trials of yoga is crucial to conclusively judge its safety.

  1. Herbal Medicines for Parkinson's Disease: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Kim, Tae-Hun; Cho, Ki-Ho; Jung, Woo-Sang; Lee, Myeong Soo

    2012-01-01

    Objective We conducted systematic review to evaluate current evidence of herbal medicines (HMs) for Parkinson's disease (PD). Methods Along with hand searches, relevant literatures were located from the electronic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED, PsycInfo, CNKI, 7 Korean Medical Databases and J-East until August, 2010 without language and publication status. Randomized controlled trials (RCTs), quasi-randomized controlled trials and randomized crossover trials, which evaluate HMs for idiopathic PD were selected for this review. Two independent authors extracted data from the relevant literatures and any disagreement was solved by discussion. Results From the 3432 of relevant literatures, 64 were included. We failed to suggest overall estimates of treatment effects on PD because of the wide heterogeneity of used herbal recipes and study designs in the included studies. When compared with placebo, specific effects were not observed in favor of HMs definitely. Direct comparison with conventional drugs suggested that there was no evidence of better effect for HMs. Many studies compared combination therapy with single active drugs and combination therapy showed significant improvement in PD related outcomes and decrease in the dose of anti-Parkinson's drugs with low adverse events rate. Conclusion Currently, there is no conclusive evidence about the effectiveness and efficacy of HMs on PD. For establishing clinical evidence of HMs on PD, rigorous RCTs with sufficient statistical power should be promoted in future. PMID:22615738

  2. Perioperative Continuous Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy: A Randomized Controlled Double-blind Trial.

    PubMed

    Fassoulaki, Argyro; Vassi, Emilia; Korkolis, Dimitrios; Zotou, Marianna

    2016-02-01

    Wound infusion with local anesthetics has been used for postoperative pain relief with variable results. This randomized, controlled, double-blind clinical trial examines the effect of ropivacaine infusion on pain after laparoscopic cholecystectomy. A total of 110 patients were randomly assigned to 2 groups. After induction of anesthesia a 75-mm catheter was inserted subcutaneously and connected to an elastomeric pump containing either 0.75% ropivacaine (ropivacaine group) or normal saline (control group) for 24 hours postoperatively. Before skin closure, each hole was infiltrated with 2 mL of 0.75% ropivacaine or normal saline according to randomization. Pain at rest, pain during cough, and analgesic consumption were recorded in the postanesthesia care unit and at 2, 4, 8, 24, and 48 hours postoperatively. Analgesic requirements and pain scores were recorded 1 and 3 months after surgery. The ropivacaine group reported less pain during cough (P=0.044) in the postanesthesia care unit (P=0.017) and 4 hours postoperatively (P=0.038). Ropivacaine wound infusion had no effect on late and chronic pain. PMID:26679680

  3. A randomized controlled trial of an automated telephone intervention to improve blood pressure control.

    PubMed

    Harrison, Teresa N; Ho, Timothy S; Handler, Joel; Kanter, Michael H; Goldberg, Ruthie A; Reynolds, Kristi

    2013-09-01

    The objective of this study was to evaluate the effectiveness of a telephonic outreach program to improve blood pressure (BP) control among patients with hypertension. The authors identified adults 18 years and older with uncontrolled BP within the previous 12 months. Patients received either an automated telephone call advising them to have a walk-in BP check (n=31,619) or usual care (n=33,154). The primary outcome was BP control at 4 weeks. Significantly more patients who received the intervention achieved BP control compared with the usual care group (32.5% vs 23.7%; P<.0001). Patients in the intervention arm with cardiovascular disease, chronic kidney disease, or diabetes mellitus achieved better BP control. Older age, female sex, and having a household income above the median were associated with BP control. When designing quality-improvement interventions to increase BP control rates, health care organizations should consider utilizing an automated telephone outreach campaign. PMID:24034658

  4. Quality and Reporting of Cluster Randomized Controlled Trials Evaluating Occupational Therapy Interventions

    PubMed Central

    Tokolahi, Ema; Hocking, Clare; Kersten, Paula; Vandal, Alain C.

    2015-01-01

    Growing use of cluster randomized control trials (RCTs) in health care research requires careful attention to study designs, with implications for the development of an evidence base for practice. The objective of this study is to investigate the characteristics, quality, and reporting of cluster RCTs evaluating occupational therapy interventions to inform future research design. An extensive search of cluster RCTs evaluating occupational therapy was conducted in several databases. Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomized, and five reported intercluster correlation coefficients (50%): Protocols had higher compliance. Risk of bias was most evident in unblinding of participants. Statistician involvement was associated with improved trial quality and reporting. Quality of cluster RCTs of occupational therapy interventions is comparable with those from other areas of health research and needs improvement. PMID:27504689

  5. A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia.

    PubMed

    Carson, James W; Carson, Kimberly M; Jones, Kim D; Bennett, Robert M; Wright, Cheryl L; Mist, Scott D

    2010-11-01

    A mounting body of literature recommends that treatment for fibromyalgia (FM) encompass medications, exercise and improvement of coping skills. However, there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping. The aim of this randomized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping. A sample of 53 female FM patients were randomized to the 8-week Yoga of Awareness program (gentle poses, meditation, breathing exercises, yoga-based coping instructions, group discussions) or to wait-listed standard care. Data were analyzed by intention to treat. At post-treatment, women assigned to the yoga program showed significantly greater improvements on standardized measures of FM symptoms and functioning, including pain, fatigue, and mood, and in pain catastrophizing, acceptance, and other coping strategies. This pilot study provides promising support for the potential benefits of a yoga program for women with FM.

  6. The case for randomized controlled trials to assess the impact of clinical information systems

    PubMed Central

    Wyatt, Jeremy C

    2011-01-01

    There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit. PMID:21270132

  7. Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

    PubMed Central

    Chow, Roberta; Pirotta, Marie

    2008-01-01

    Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs) of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection. PMID:18955233

  8. Design and conduct of a large obstetric or neonatal randomized controlled trial.

    PubMed

    Tarnow-Mordi, William; Cruz, Melinda; Morris, Jonathan

    2015-12-01

    As event rates fall, if mortality and disability are to improve further there is increasing need for large, well-designed trials. These should enroll more patients, more rapidly and at lower cost, with better representation of infants at highest risk and greater integration with routine care. This may require simpler datasets, linkage with routinely collected data, and international collaboration. It may be helpful to draw attention to recent evidence that participation in Phase III randomized controlled trials (RCTs) is at least as safe as receiving established care. Nationally coordinated clinical research networks employing local research staff may be the single most effective strategy to integrate clinical trials into routine practice. Other goals are: international standardization of outcomes; consensus on composite endpoints, biomarkers, surrogates and measures of disability; greater efficiency through randomized factorial designs and cluster or cross-over cluster RCTs; and equipping parents as partners in all aspects of the conduct of RCTs and in implementing their results. PMID:26522427

  9. Lysergic acid diethylamide (LSD) for alcoholism: meta-analysis of randomized controlled trials.

    PubMed

    Krebs, Teri S; Johansen, Pål-Ørjan

    2012-07-01

    Assessments of lysergic acid diethylamide (LSD) in the treatment of alcoholism have not been based on quantitative meta-analysis. Hence, we performed a meta-analysis of randomized controlled trials in order to evaluate the clinical efficacy of LSD in the treatment of alcoholism. Two reviewers independently extracted the data, pooling the effects using odds ratios (ORs) by a generic inverse variance, random effects model. We identified six eligible trials, including 536 participants. There was evidence for a beneficial effect of LSD on alcohol misuse (OR, 1.96; 95% CI, 1.36-2.84; p = 0.0003). Between-trial heterogeneity for the treatment effects was negligible (I² = 0%). Secondary outcomes, risk of bias and limitations are discussed. A single dose of LSD, in the context of various alcoholism treatment programs, is associated with a decrease in alcohol misuse.

  10. Personal view: randomized controlled trials in epilepsy specialist nursing: the seduction of content by form.

    PubMed

    Brown, Stephen

    2002-04-01

    Research into the effectiveness of epilepsy specialist nursing needs to take into account a number of factors, which have not been adequately addressed in previous studies. Nursing outcome measures are different to medical ones and it is inappropriate to confuse these. Specialist nurses affect the whole culture of a service, and their impact on service quality may go beyond that of their individual patient contacts. Thus randomized studies within a service that already has specialist nurses may not give valid results. Some service users will benefit more from direct contact with a specialist nurse than others, and people who give informed consent to take part in randomized controlled trials might not be representative of those who would benefit most from specialist nurse access. The stampede for level one evidence risks failing to address the issues properly by overvaluing research process (form) against its appropriateness (content), yet there remain great opportunities for good quality research in this area.

  11. Personal view: Randomized controlled trials in epilepsy specialist nursing: the seduction of content by form.

    PubMed

    Brown, S

    2001-12-01

    Research into the effectiveness of epilepsy specialist nursing needs to take into account a number of factors, which have not been adequately addressed in previous studies. Nursing outcome measures are different to medical ones and it is inappropriate to confuse these. Specialist nurses affect the whole culture of a service, and their impact on service quality may go beyond that of their individual patient contacts. Thus randomized studies within a service that already has specialist nurses may not give valid results. Some service users will benefit more from direct contact with a specialist nurse than others, and people who give informed consent to take part in randomized controlled trials might not be representative of those who would benefit most from specialist nurse access. The stampede for level one evidence risks failing to address the issues properly by overvaluing research process (form) against its appropriateness (content), yet there remain great opportunities for good quality research in this area.

  12. Differential Effect of Taekwondo Training on Knee Muscle Strength and Reactive and Static Balance Control in Children with Developmental Coordination Disorder: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Fong, Shirley S. M.; Chung, Joanne W. Y.; Chow, Lina P. Y.; Ma, Ada W. W.; Tsang, William W. N.

    2013-01-01

    This randomized controlled trial aimed to investigate the effect of short-term intensive TKD training on the isokinetic knee muscle strength and reactive and static balance control of children with developmental coordination disorder (DCD). Among the 44 children with DCD (mean age: 7.6 plus or minus 1.3 years) recruited, 21 were randomly assigned…

  13. Effects of Periodontal Therapy on Rate of Preterm Delivery A Randomized Controlled Trial

    PubMed Central

    Offenbacher, Steven; Beck, James D.; Jared, Heather L.; Mauriello, Sally M.; Mendoza, Luisto C.; Couper, David J.; Stewart, Dawn D.; Murtha, Amy P.; Cochran, David L.; Dudley, Donald J.; Reddy, Michael S.; Geurs, Nicolaas C.; Hauth, John C.

    2010-01-01

    OBJECTIVE To test the effects of maternal periodontal disease treatment on the incidence of preterm birth (delivery before 37 weeks of gestation). METHODS The Maternal Oral Therapy to Reduce Obstetric Risk Study was a randomized, treatment-masked, controlled clinical trial of pregnant women with periodontal disease who were receiving standard obstetric care. Participants were assigned to either a periodontal treatment arm, consisting of scaling and root planing early in the second trimester, or a delayed treatment arm that provided periodontal care after delivery. Pregnancy and maternal periodontal status were followed to delivery and neonatal outcomes until discharge. The primary outcome (gestational age less than 37 weeks) and the secondary outcome (gestational age less than 35 weeks) were analyzed using a χ2 test of equality of two proportions. RESULTS The study randomized 1,806 patients at three performance sites and completed 1,760 evaluable patients. At baseline, there were no differences comparing the treatment and control arms for any of the periodontal or obstetric measures. The rate of preterm delivery for the treatment group was 13.1% and 11.5% for the control group (P=.316). There were no significant differences when comparing women in the treatment group with those in the control group with regard to the adverse event rate or the major obstetric and neonatal outcomes. CONCLUSION Periodontal therapy did not reduce the incidence of preterm delivery. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, www.clinicaltrials.gov, NCT00097656. LEVEL OF EVIDENCE I PMID:19701034

  14. General acteoside of Rehmanniae leaves in the treatment of primary chronic glomerulonephritis: a randomized controlled trial.

    PubMed

    Qiu, HongYu; Fan, WenXing; Fu, Ping; Zuo, Chuan; Feng, Ping; Liu, Fang; Zhou, Li; Chen, Feng; Zhong, Hui; Liang, YaPing; Shi, Mei

    2013-01-01

    The objective of the study was to investigate the effectiveness and efficacy of the randomized, parallel, and controlled trial of Traditional Chinese Medicine, general acteoside of Rehmanniae leaves, compared with piperazine ferulate in the treatment of primary chronic glomerulonephritis. Rehmanniae leaves and piperazine ferulate can reduce proteinuria and erythrocyturia effectively in the treatment of primary chronic glomerulonephritis. A total of 400 patients diagnosed with primary chronic glomerulonephritis were recruited from outpatient clinics and were randomly assigned to the treatment group (general acteoside of Rehmanniae leaves, two 200mg tablets, bid) or the control group (piperazine ferulate, four 50-mg tablets, bid ). The primary outcome was 24-h urinary protein. Secondary outcome measures included estimated glomerular filtration rate (eGFR), erythrocyturia, and electrolytes. After 8 weeks of treatment, the treatment group and the control group showed a mean reduction in 24-h proteinuria of 34.81% and 37.66%. The 95% CI of difference of the mean reduction in 24-h proteinuria between the two groups was [-11.50%, 5.80%]. No significant differences were found between the two groups in the erythrocyturia reduction. Neither group showed obvious changes between baseline and 8 weeks in eGFR or electrolytes. Adverse events occurred at a similarly low rate in the treatment group (1.5%) and control group (2.5%, P = 0.7238). Both general acteoside of Rehmanniae leaves and piperazine ferulate can reduce proteinuria and erythrocyturia effectively in the treatment of primary chronic glomerulonephritis.

  15. Beneficial Effect of Cyproheptadine on Body Mass Index in Undernourished Children: A Randomized Controlled Trial

    PubMed Central

    Najib, Khadijehsadat; Karamizadeh, Zohreh; Fallahzadeh, Ebrahim

    2014-01-01

    Objective: Cyproheptadine hydrochloride (CH) is a first-generation antihistamine which is used as an appetite stimulant. This study was designed to identify the role of CH therapy on weight gain, linear growth and body mass index in children with mild to moderate undernutrition. Methods: Eighty-nine patients were enrolled. The present randomized, double-blinded controlled trial included 77 evaluable patients, aged 24–64 months with undernutrition. The patients were randomized to receive cyproheptadine with multivitamin, or multivitamin over a period of four weeks. The weight, height and body mass index were measured at the baseline, four weeks after intervention and four weeks after discontinuation. Findings: A significant higher body mass index was observed among CH-treated patients after 8 weeks intervention with cyproheptadine compared with the control group (P<0.041). Mean weight gain after eight weeks was 0.11 kg in the control group and 0.60 kg in the CH group. There were no significant differences in changes of weight and height velocity across the study between CH-treated and control group at the end of study. Conclusion: In our study, cyproheptadine promotes increase in body mass index in children with mild to moderate undernutrition after four weeks treatment. PMID:26019782

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

    PubMed

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

    2014-02-01

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

  17. Efficacy of a triclosan formula in controlling early subgingival biofilm formation: a randomized trial.

    PubMed

    Andrade, Ernesto; Weidlich, Patricia; Angst, Patrícia Daniela Melchiors; Gomes, Sabrina Carvalho; Oppermann, Rui Vicente

    2015-01-01

    The aim of this study was to determine the efficacy of rinses with slurries of a dentifrice containing triclosan (TCS), as compared with rinses with slurries from a control dentifrice, in controlling early subgingival biofilm formation. A double-blind, randomized and cross-over clinical trial was designed, and 26 dental students were included. In the first period, participants were randomized to rinse with a TCS slurry or a control slurry, in a 12 h interval, and to refrain from mechanical cleaning. A Plaque Free Zone Index was assessed at 24 h, 48 h, 72 h and 96 h. After a washout period of 10 days, the second experimental period was conducted, following the same protocol as the first period, except that the slurry groups were switched. Use of the TCS slurry resulted in a significantly higher percentage of plaque-free surfaces, both at 24 h and at 72 h (p < 0.01). In the of 48-72 h interval, the triclosan slurry showed a lower percentage of sites converted to a score of 2 (38.1% for the test versus 40% for the control product, p = 0.015). In conclusion, rinsing with slurries of dentifrice containing TCS retards the down growth of bacterial biofilms from the supra- to the subgingival environment. PMID:26039907

  18. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    PubMed

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p < 0.05). The total sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended.

  19. Insulation workers in Belfast. 1. Comparison of a random sample with a control population1

    PubMed Central

    Wallace, William F. M.; Langlands, Jean H. M.

    1971-01-01

    Wallace, W. F. M., and Langlands, J. H. M. (1971).Brit. J. industr. Med.,28, 211-216. Insulation workers in Belfast. 1. Comparison of a random sample with a control population. A sample of 50 men was chosen at random from the population of asbestos insulators in Belfast and matched with a control series of men of similar occupational group with respect to age, height, and smoking habit. Significantly more of the insulators complained of cough and sputum and had basal rales on examination. Clubbing was assessed by means of measurements of the hyponychial angle of both index fingers. These angles were significantly greater in the group of insulators. Twenty-one insulators had ϰ-rays which showed pleural calcification with or without pulmonary fibrosis; one control ϰ-ray showed pulmonary fibrosis. The insulators had no evidence of airways obstruction but static lung volume was reduced and their arterial oxygen tension was lower than that of the controls and their alveolar-arterial oxygen gradient was greater. PMID:5557841

  20. The effects of intravenous ephedrine during spinal anesthesia for cesarean delivery: a randomized controlled trial.

    PubMed

    Kol, Iclal Ozdemir; Kaygusuz, Kenan; Gursoy, Sinan; Cetin, Ali; Kahramanoglu, Zeki; Ozkan, Fikret; Mimaroglu, Caner

    2009-10-01

    We designed a randomized, double-blinded study to determine the efficacy and safety of 0.5 mg/kg intravenous ephedrine for the prevention of hypotension during spinal anesthesia for cesarean delivery. Patients were randomly allocated into two groups: ephedrine group (n=21) and control group (n=21). Intravenous preload of 15 mL/kg lactated Ringer's solution was given. Shortly after the spinal injection, ephedrine 0.5 mg/kg or saline was injected intravenous for 60 sec. The mean of highest and lowest heart rate in the ephedrine group was higher than those of control group (P<0.05). There were significant lower incidences of hypotension and nausea and vomiting in the ephedrine group compared with the control group (8 [38.1%] vs. 18 [85.7%]); (4 [19%] vs. 12 [57.1%], respectively) (P<0.05). The first rescue ephedrine time in the ephedrine group was significantly longer (14.9+/-7.1 min vs. 7.9+/-5.4 min) than that of the control group (P<0.05). Neonatal outcome were similar between the study groups. These findings suggest, the prophylactic bolus dose of 0.5 mg/kg intravenous ephedrine given at the time of intrathecal block after a crystalloid fluid preload, plus rescue boluses reduce the incidence of hypotension.

  1. Efficacy of a triclosan formula in controlling early subgingival biofilm formation: a randomized trial.

    PubMed

    Andrade, Ernesto; Weidlich, Patricia; Angst, Patrícia Daniela Melchiors; Gomes, Sabrina Carvalho; Oppermann, Rui Vicente

    2015-01-01

    The aim of this study was to determine the efficacy of rinses with slurries of a dentifrice containing triclosan (TCS), as compared with rinses with slurries from a control dentifrice, in controlling early subgingival biofilm formation. A double-blind, randomized and cross-over clinical trial was designed, and 26 dental students were included. In the first period, participants were randomized to rinse with a TCS slurry or a control slurry, in a 12 h interval, and to refrain from mechanical cleaning. A Plaque Free Zone Index was assessed at 24 h, 48 h, 72 h and 96 h. After a washout period of 10 days, the second experimental period was conducted, following the same protocol as the first period, except that the slurry groups were switched. Use of the TCS slurry resulted in a significantly higher percentage of plaque-free surfaces, both at 24 h and at 72 h (p < 0.01). In the of 48-72 h interval, the triclosan slurry showed a lower percentage of sites converted to a score of 2 (38.1% for the test versus 40% for the control product, p = 0.015). In conclusion, rinsing with slurries of dentifrice containing TCS retards the down growth of bacterial biofilms from the supra- to the subgingival environment.

  2. The Efficacy of Computerized Cognitive Training in Adults With ADHD: A Randomized Controlled Trial.

    PubMed

    Stern, Adi; Malik, Elad; Pollak, Yehuda; Bonne, Omer; Maeir, Adina

    2014-04-22

    Objective: This is a randomized control trial examining the efficiency of computerized cognitive training (CCT) for adults with ADHD, comparing two training conditions with graded levels of executive cognitive demands. Method: Adults with ADHD (n = 60) were randomized into study (n = 34) and control (n = 26) groups. Training was conducted with the computerized AttenFocus program. Control group received a simple, non-hierarchical version with less executive demands. Results: Significant positive changes in symptoms ratings, ecological measures of executive functions, and occupational performance were found in both groups. No significant changes were found in variables of neurocognitive performance battery and quality of life. No significant time by group interaction effects were found. Conclusion: No benefits of the intervention were found relative to the control. Lack of interaction effects may be due to insufficient power, non-specific cognitive training or placebo effects. Results demonstrate some positive findings for general CCT, yet do not support the inclusion of specific higher level executive training. PMID:24756172

  3. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    PubMed

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p < 0.05). The total sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended. PMID:26757356

  4. An Evaluation of the Effectiveness of Recruitment Methods: The Staying Well after Depression Randomized Controlled Trial

    PubMed Central

    Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J. Mark G.

    2014-01-01

    Background Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited and trials often fail to report sufficient details about the recruitment sources and resources utilised. Purpose We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. Methods We describe eight recruitment methods utilised and two further sources not initiated by the research team and examine their efficacy in terms of (i) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial, (ii) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants, and (iii) comparison of sociodemographic characteristics of individuals recruited from different sources. Results Poster advertising, web-based advertising and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. Limitations It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other

  5. Automated Internet-based pain coping skills training to manage osteoarthritis pain: a randomized controlled trial.

    PubMed

    Rini, Christine; Porter, Laura S; Somers, Tamara J; McKee, Daphne C; DeVellis, Robert F; Smith, Meredith; Winkel, Gary; Ahern, David K; Goldman, Roberta; Stiller, Jamie L; Mariani, Cara; Patterson, Carol; Jordan, Joanne M; Caldwell, David S; Keefe, Francis J

    2015-05-01

    Osteoarthritis (OA) places a significant burden on worldwide public health because of the large and growing number of people affected by OA and its associated pain and disability. Pain coping skills training (PCST) is an evidence-based intervention targeting OA pain and disability. To reduce barriers that currently limit access to PCST, we developed an 8-week, automated, Internet-based PCST program called PainCOACH and evaluated its potential efficacy and acceptability in a small-scale, 2-arm randomized controlled feasibility trial. Participants were 113 men and women with clinically confirmed hip or knee OA and associated pain. They were randomized to a group completing PainCOACH or an assessment-only control group. Osteoarthritis pain, pain-related interference with functioning, pain-related anxiety, self-efficacy for pain management, and positive and negative affect were measured before intervention, midway through the intervention, and after intervention. Findings indicated high acceptability and adherence: 91% of participants randomized to complete PainCOACH finished all 8 modules over 8 to 10 weeks. Linear mixed models showed that, after treatment, women who received the PainCOACH intervention reported significantly lower pain than that in women in the control group (Cohen d = 0.33). Intervention effects could not be tested in men because of their low pain and small sample size. Additionally, both men and women demonstrated increases in self-efficacy from baseline to after intervention compared with the control group (d = 0.43). Smaller effects were observed for pain-related anxiety (d = 0.20), pain-related interference with functioning (d = 0.13), negative affect (d = 0.10), and positive affect (d = 0.24). Findings underscore the value of continuing to develop an automated Internet-based approach to disseminate this empirically supported intervention.

  6. Alcohol Interventions Among Underage Drinkers in the ED: A Randomized Controlled Trial

    PubMed Central

    Chermack, Stephen T.; Ehrlich, Peter F.; Carter, Patrick M.; Booth, Brenda M.; Blow, Frederic C.; Barry, Kristen L.; Walton, Maureen A.

    2015-01-01

    OBJECTIVES: This study examined the efficacy of emergency department (ED)-based brief interventions (BIs), delivered by a computer or therapist, with and without a post-ED session, on alcohol consumption and consequences over 12 months. METHODS: Patients (ages 14–20 years) screening positive for risky drinking were randomized to: BI (n = 277), therapist BI (n = 278), or control (n = 281). After the 3-month follow-up, participants were randomized to receive a post-ED BI session or control. Incorporating motivational interviewing, the BIs addressed alcohol consumption and consequences, including driving under the influence (DUI), and alcohol-related injury, as well as other concomitant drug use. The computer BI was an offline, Facebook-styled program. RESULTS: Among 4389 patients screened, 1054 patients reported risky drinking and 836 were enrolled in the randomized controlled trial. Regression models examined the main effects of the intervention conditions (versus control) and the interaction effects (ED condition × post-ED condition) on primary outcomes. The therapist and computer BIs significantly reduced consumption at 3 months, consequences at 3 and 12 months, and prescription drug use at 12 months; the computer BI reduced the frequency of DUI at 12 months; and the therapist BI reduced the frequency of alcohol-related injury at 12 months. The post-ED session reduced alcohol consequences at 6 months, benefiting those who had not received a BI in the ED. CONCLUSIONS: A single-session BI, delivered by a computer or therapist in the ED, shows promise for underage drinkers. Findings for the fully automated stand-alone computer BI are particularly appealing given the ease of future implementation. PMID:26347440

  7. A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

    PubMed Central

    Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

    2015-01-01

    Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

  8. Staff training and ambulatory tuberculosis treatment outcomes: a cluster randomized controlled trial in South Africa.

    PubMed Central

    Lewin, Simon; Dick, Judy; Zwarenstein, Merrick; Lombard, Carl J.

    2005-01-01

    OBJECTIVE: To assess whether adding a training intervention for clinic staff to the usual DOTS strategy (the internationally recommended control strategy for tuberculosis (TB)) would affect the outcomes of TB treatment in primary care clinics with treatment success rates below 70%. METHODS: A cluster randomized controlled trial was conducted from July 1996 to July 2000 in nurse-managed ambulatory primary care clinics in Cape Town, South Africa. Clinics with successful TB treatment completion rates of less than 70% and annual adult pulmonary TB loads of more than 40 patients per year were randomly assigned to either the intervention (n = 12) or control (n = 12) groups. All clinics completed follow-up. Treatment outcomes were measured in cohorts of adult, pulmonary TB patients before the intervention (n = 1200) and 9 months following the training (n = 1177). The intervention comprised an 18-hour experiential, participatory in-service training programme for clinic staff delivered by nurse facilitators and focusing on patient centredness, critical reflection on practice, and quality improvement. The main outcome measure was successful treatment, defined as patients who were cured and those who had completed tuberculosis treatment. FINDINGS: The estimated effect of the intervention was an increase in successful treatment rates of 4.8% (95% confidence interval (CI): -5.5% to 15.2%) and in bacteriological cure rates of 10.4% (CI: -1.2% to 22%). A treatment effect of 10% was envisaged, based on the views of policy-makers on the minimum effect size for large-scale implementation. CONCLUSION: This is the first evidence from a randomized controlled trial on the effects of experiential, participatory training on TB outcomes in primary care facilities in a developing country. Such training did not appear to improve TB outcomes. However, the results were inconclusive and further studies are required. PMID:15868015

  9. How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials

    PubMed Central

    2010-01-01

    Background While several recent large randomized trials found clinically relevant effects of acupuncture over no treatment or routine care, blinded trials comparing acupuncture to sham interventions often reported only minor or no differences. This raises the question whether (sham) acupuncture is associated with particularly potent nonspecific effects. We aimed to investigate the size of nonspecific effects associated with acupuncture interventions. Methods MEDLINE, Embase, Cochrane Central Register of Controlled Clinical Trials and reference lists were searched up to April 2010 to identify randomized trials of acupuncture for any condition, including both sham and no acupuncture control groups. Data were extracted by one reviewer and verified by a second. Pooled standardized mean differences were calculated using a random effects model with the inverse variance method. Results Thirty-seven trials with a total of 5754 patients met the inclusion criteria. The included studies varied strongly regarding patients, interventions, outcome measures, methodological quality and effect sizes reported. Among the 32 trials reporting a continuous outcome measure, the random effects standardized mean difference between sham acupuncture and no acupuncture groups was -0.45 (95% confidence interval, -0.57, -0.34; I2 = 54%; Egger's test for funnel plot asymmetry, P = 0.25). Trials with larger effects of sham over no acupuncture reported smaller effects of acupuncture over sham intervention than trials with smaller nonspecific effects (β = -0.39, P = 0.029). Conclusions Sham acupuncture interventions are often associated with moderately large nonspecific effects which could make it difficult to detect small additional specific effects. Compared to inert placebo interventions, effects associated with sham acupuncture might be larger, which would have considerable implications for the design and interpretation of clinical trials. PMID:21092261

  10. A four-kallikrein panel predicts prostate cancer in men with recent screening: data from the European Randomized Study of Prostate Cancer Screening, Rotterdam

    PubMed Central

    Vickers, Andrew J.; Cronin, Angel M; Roobol, Monique J.; Savage, Caroline J.; Peltola, Mari; Pettersson, Kim; Scardino, Peter T.; Schröder, Fritz H.; Lilja, Hans

    2010-01-01

    Purpose We have developed a statistical prediction model for prostate cancer based on four kallikrein markers in blood: total, free, and intact prostate specific antigen (PSA) and kallikrein-related peptidase 2 (hK2). Although this model accurately predicts the result of biopsy in unscreened men, its properties for men with a history of PSA screening have not been fully characterized. Experimental Design 1501 previously screened men with elevated PSA underwent initial biopsy during rounds 2 and 3 of the European Randomized Study of Prostate Cancer Screening, Rotterdam, with 388 cancers diagnosed. Biomarker levels were measured in serum samples taken before biopsy. The prediction model developed on the unscreened cohort was then applied and predictions compared to biopsy outcome. Results The previously developed four-kallikrein prediction model had much higher predictive accuracy than PSA and age alone (area-under-the-curve of 0.711 vs. 0.585 and 0.713 vs. 0.557 with and without digital rectal exam, respectively; both p<0.001). Similar statistically significant enhancements were seen for high-grade cancer. Applying the model with a cut-off of 20% cancer risk as the criterion for biopsy would reduce the biopsy rate by 362 for every 1000 men with elevated PSA. Although diagnosis would be delayed for 47 cancers, these would be predominately low stage and low grade (83% Gleason 6 T1c). Conclusions A panel of four kallikreins can help predict the result of initial biopsy in previously screened men with elevated PSA. Use of a statistical model based on the panel would substantially decrease rates of unnecessary biopsy. PMID:20400522

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

    PubMed Central

    2012-01-01

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

  12. 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

  13. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

    PubMed Central

    Azar, Kristen MJ; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

    2015-01-01

    Background In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions The randomized trial will provide rigorous evidence regarding the efficacy of

  14. Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Hip fractures are very painful leading to lengthy hospital stays. Conventional methods of treating pain are limited. Non-steroidal anti-inflammatories are relatively contraindicated and opioids have significant side effects.Regional anaesthesia holds promise but results from these techniques are inconsistent. Trials to date have been inconclusive with regard to which blocks to use and for how long. Interpatient variability remains a problem. Methods/Design This is a single centre study conducted at Queen’s Medical Centre, Nottingham; a large regional trauma centre in England. It is a pragmatic, parallel arm, randomized controlled trial. Sample size will be 150 participants (75 in each group). Randomization will be web-based, using computer generated concealed tables (service provided by Nottingham University Clinical Trials Unit). There is no blinding. Intervention will be a femoral nerve block (0.5 mls/kg 0.25% levo-bupivacaine) followed by ropivacaine (0.2% 5 ml/hr−1) infused via a femoral nerve catheter until 48 hours post-surgery. The control group will receive standard care. Participants will be aged over 70 years, cognitively intact (abbreviated mental score of seven or more), able to provide informed consent, and admitted directly through the Emergency Department from their place of residence. Primary outcomes will be cumulative ambulation score (from day 1 to 3 postoperatively) and cumulative dynamic pain scores (day 1 to 3 postoperatively). Secondary outcomes will be cumulative dynamic pain score preoperatively, cumulative side effects, cumulative calorific and protein intake, EUROQOL EQ-5D score, length of stay, and rehabilitation outcome (measured by mobility score). Discussion Many studies have shown the effectiveness of regional blockade in neck of femur fractures, but the techniques used have varied. This study aims to identify whether early and continuous femoral nerve block can be effective in relieving pain and enhancing mobilization

  15. Clinical Hypnosis in the Treatment of Post-Menopausal Hot Flashes: A Randomized Controlled Trial

    PubMed Central

    Elkins, Gary R.; Fisher, William I.; Johnson, Aimee K.; Carpenter, Janet S.; Keith, Timothy Z.

    2012-01-01

    Objective The use of estrogen and progesterone to manage vasomotor symptoms (i.e., hot flashes, night sweats) has declined due to concerns over their risks and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized, controlled trial of clinical hypnosis in treating vasomotor symptoms among post-menopausal women. Methods Randomized, single-blind, controlled, clinical trial involving 187 post-menopausal women reporting a minimum of seven hot flashes per day, or at least 50 hot flashes a week at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries at weeks 2–6, and 12. Secondary outcomes included measures of hot flash related daily interference, sleep quality and treatment satisfaction. Results In a modified intent-to-treat analysis that included all randomized participants that provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 hot flashes for the clinical hypnosis intervention (74.16%), versus a 12.89 hot flash reduction (17.13%) for the control (p<.001, 95% CI, 36.15–49.67). Mean reduction in hot flash score was 18.83 (80.32%) for the clinical hypnosis intervention as compared to 3.53 (15.38%) for the control (p<.001, 95% CI, 12.60–17.54). At 12 week follow-up, the mean reduction in physiologically monitored hot flashes was 5.92 (56.86%) for clinical hypnosis and .88 (9.94%) for the control (p<.001, 95% CI, 2.00–5.46). Secondary outcomes were significantly improved compared to control at 12 week follow-up in hot flash related interference (p<.001, 95% CI, 2.74–4.02), sleep quality (p<.001, 95% CI, 3.65–5.84), and treatment satisfaction (p<.001, 95% CI, 7.79–8.59). Conclusion Compared

  16. Applying an equity lens to tobacco-control policies and their uptake in six Western-European countries.

    PubMed

    Giskes, K; Kunst, A E; Ariza, C; Benach, J; Borrell, C; Helmert, U; Judge, K; Lahelma, E; Moussa, K; Ostergren, P O; Patja, K; Platt, S; Prättälä, R; Willemsen, M C; Mackenbach, J P

    2007-07-01

    We identified policies that may be effective in reducing smoking among socioeconomically disadvantaged groups, and examined trends in their level of application between 1985 and 2000 in six western-European countries (Sweden, Finland, the United Kingdom, the Netherlands, Germany, and Spain). We located studies from literature searches in major databases, and acquired policy data from international data banks and questionnaires distributed to tobacco policy organisations/researchers. Advertising bans, smoking bans in workplaces, removing barriers to smoking cessation therapies, and increasing the cost of cigarettes have the potential to reduce socioeconomic inequalities in smoking. Between 1985 and 2000, tobacco control policies in most countries have become more targeted to decrease the smoking behaviour of low-socioeconomic groups. Despite this, many national tobacco-control strategies in western-European countries still fall short of a comprehensive policy approach to addressing smoking inequalities.

  17. The prevention of depressive symptoms in rural school children: a randomized controlled trial.

    PubMed

    Roberts, Clare; Kane, Robert; Thomson, Helen; Bishop, Brian; Hart, Bret

    2003-06-01

    A controlled trial was conducted to evaluate a prevention program aimed at reducing depressive and anxious symptoms in rural school children. Seventh-grade children with elevated depression were selected. Nine primary schools (n = 90) were randomly assigned to receive the program, and 9 control schools (n = 99) received their usual health education classes. Children completed questionnaires on depression, anxiety, explanatory style, and social skills. Parents completed the Child Behavior Checklist (T. M. Achenbach, 1991). No intervention effects were found for depression. Intervention group children reported less anxiety than the control group after the program and at 6-month follow-up and more optimistic explanations at postintervention. Intervention group parents reported fewer child internalizing and externalizing symptoms at postintervention only. PMID:12795585

  18. A Double-Blind Randomized Controlled Trial of Continuous Intravenous Ketorolac vs Placebo for Adjuvant Pain Control After Renal Surgery

    PubMed Central

    Grimsby, Gwen M.; Conley, Sarah P.; Trentman, Terrence L.; Castle, Erik P.; Andrews, Paul E.; Mihalik, Laurie A.; Hentz, Joseph G.; Humphreys, Mitchell R.

    2012-01-01

    Objective To evaluate the efficacy and safety of a novel, continuous intravenous infusion of ketorolac, a powerful nonopioid analgesic, for postoperative pain control. Patients and Methods A prospective, double-blind, randomized, placebo-controlled trial of a continuous infusion of ketorolac tromethamine in 1 L of normal saline vs placebo was performed in 135 patients aged 18 to 75 years after laparoscopic donor nephrectomy or percutaneous nephrolithotomy completed from October 7, 2008, through July 21, 2010. Primary study end points were the 24-hour differences in visual analog pain scores and total narcotic consumption, whereas secondary end points were differences in urine output, serum creatinine level, and hemoglobin level. Results The study was stopped after randomization of 135 patients (68 in the ketorolac group and 67 in the placebo group) when interim analysis indicated that the difference in mean pain scores between the 2 groups (difference, 0.6) was smaller than the 1-point threshold set forth in the power calculations. No statistically significant change was noted in hemoglobin levels from preoperative to postoperative values (P=.13) or in postoperative serum creatinine levels (P=.13). Conclusion Although continuous infusion of ketorolac produced only a modest decrease in the use of narcotics, it appears to offer a safe therapeutic option for nonnarcotic pain control. Trial Registration clinicaltrials.gov Identifiers: NCT00765128 and NCT00765232 PMID:23058854

  19. Introduction to the special issue on the 2011 Joint IEEE International Frequency Control Symposium and European Frequency and Time Forum.

    PubMed

    Burt, Eric; Gill, Patrick

    2012-03-01

    The 8 invited and 17 contributed papers in this special issue focus on the following topical areas covered at the 2011 Joint IEEE International Frequency Control Symposium and European Frequency and Time Forum, held in San Francisco, California: 1) Materials and Resonators; 2) Oscillators, Synthesizers, and Noise; 3) Microwave Frequency Standards; 4) Sensors and Transducers; 5) Timekeeping and Time and Frequency Transfer; and 6) Optical Frequency Standards.

  20. Hypnosis as a treatment of chronic widespread pain in general practice: A randomized controlled pilot trial

    PubMed Central

    Grøndahl, Jan Robert; Rosvold, Elin Olaug

    2008-01-01

    Background Hypnosis treatment in general practice is a rather new concept. This pilot study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP). Methods The study was designed as a randomized control group-controlled study. Sixteen patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering. Data were analyzed by means of T-tests. Results The treatment group improved from their symptoms, (change from 62.5 to 55.4), while the control group deteriorated, (change from 37.2 to 45.1), (p = 0,045). The 12 patients who completed the treatment showed a mean improvement from 51.5 to 41.6. (p = 0,046). One year later the corresponding result was 41.3, indicating a persisting improvement. Conclusion The study indicates that hypnosis treatment may have a positive effect on pain and quality of life for patients with chronic muscular pain. Considering the limited number of patients, more studies should be conducted to confirm the results. Trial Registration The study was registered in ClinicalTrials.gov and released 27.08.07 Reg nr NCT00521807 Approval Number: 05032001. PMID:18801190

  1. Effect of Ayurvedic herbs on control of plaque and gingivitis: A randomized controlled trial

    PubMed Central

    Kadam, Avinash; Prasad, B. S.; Bagadia, Dilesh; Hiremath, V. R.

    2011-01-01

    Ayurveda had mentioned various procedures for maintaining oral hygiene. These include procedures like gandusha, kavala, dantadhavana, and jivha lekhana (cleaning tongue). Various plants have been mentioned in Ayurveda for dantakashta. Various Ayurvedic dental formulations are available in market in the form of powders, paste, etc. Present study was conducted for evaluating the effect of one of such Ayurvedic toothpowder named UDM, in controlling plaque and reducing gum inflammation in patients of moderate gingivitis. Scaling, root planning, and polishing were done for all the patients participating in the study. Oral hygiene instructions were given that included brushing twice/day with assigned tooth powder using BASS method for tooth brushing and also massage over gum tissue with finger. All the patients were recalled after 15 days. Scores of plaque index and gingival index was recorded on day 1 and day 15 of treatment. Total of 15 patients were recruited in each group. The mean reduction in gingival index was 1.15 (P<0.05) and 1.26 (P<0.05) in positive control and UDM treatment groups, respectively. However, the mean reduction in plaque indices were found to be 2.03 (P<0.05) and 2.16 (P<0.05) in positive control and UDM groups, respectively. No significant difference was seen in both the parameters between the two groups. PMID:22661849

  2. Do motion controllers make action video games less sedentary? A randomized experiment.

    PubMed

    Lyons, Elizabeth J; Tate, Deborah F; Ward, Dianne S; Ribisl, Kurt M; Bowling, J Michael; Kalyanaraman, Sriram

    2012-01-01

    Sports- and fitness-themed video games using motion controllers have been found to produce physical activity. It is possible that motion controllers may also enhance energy expenditure when applied to more sedentary games such as action games. Young adults (N = 100) were randomized to play three games using either motion-based or traditional controllers. No main effect was found for controller or game pair (P > .12). An interaction was found such that in one pair, motion control (mean [SD] 0.96 [0.20] kcal · kg(-1) · hr(-1)) produced 0.10 kcal · kg(-1) · hr(-1) (95% confidence interval 0.03 to 0.17) greater energy expenditure than traditional control (0.86 [0.17] kcal · kg(-1) · hr(-1), P = .048). All games were sedentary. As currently implemented, motion control is unlikely to produce moderate intensity physical activity in action games. However, some games produce small but significant increases in energy expenditure, which may benefit health by decreasing sedentary behavior.

  3. An 8-Month Randomized Controlled Exercise Trial Alters Brain Activation During Cognitive Tasks in Overweight Children

    PubMed Central

    Krafft, Cynthia E.; Schwarz, Nicolette F.; Chi, Lingxi; Weinberger, Abby L.; Schaeffer, David J.; Pierce, Jordan E.; Rodrigue, Amanda L.; Yanasak, Nathan E.; Miller, Patricia H.; Tomporowski, Phillip D.; Davis, Catherine L.; McDowell, Jennifer E.

    2014-01-01

    Objective Children who are less fit reportedly have lower performance on tests of cognitive control and differences in brain function. This study examined the effect of an exercise intervention on brain function during two cognitive control tasks in overweight children. Design and Methods Participants included 43 unfit, overweight (BMI ≥ 85th percentile) children 8- to 11-years old (91% Black), who were randomly divided into either an aerobic exercise (n = 24) or attention control group (n = 19). Each group was offered a separate instructor-led after-school program every school day for 8 months. Before and after the program, all children performed two cognitive control tasks during functional magnetic resonance imaging (fMRI): antisaccade and flanker. Results Compared to the control group, the exercise group decreased activation in several regions supporting antisaccade performance, including precentral gyrus and posterior parietal cortex, and increased activation in several regions supporting flanker performance, including anterior cingulate and superior frontal gyrus. Conclusions Exercise may differentially impact these two task conditions, or the paradigms in which cognitive control tasks were presented may be sensitive to distinct types of brain activation that show different effects of exercise. In sum, exercise appears to alter efficiency or flexible modulation of neural circuitry supporting cognitive control in overweight children. PMID:23788510

  4. Random-start GnRH antagonist for emergency fertility preservation: a self-controlled trial

    PubMed Central

    Checa, Miguel A; Brassesco, Mario; Sastre, Margalida; Gómez, Manuel; Herrero, Julio; Marque, Laura; Brassesco, Arturo; Espinós, Juan José

    2015-01-01

    The aim of this study is to evaluate the feasibility and safety of random-start controlled ovarian hyperstimulation (COH) for emergency fertility preservation, regardless of the phase of the menstrual cycle. A self-controlled pilot clinical trial (NCT01385332) was performed in an acute-care teaching hospital and in two private reproductive centers in Barcelona, Spain. Eleven egg donors participated in the study. Two random-start gonadotropin-releasing hormone (GnRH) antagonist protocols were assessed in which ganirelix was initiated on either day 10 (protocol B) or on day 20 (protocol C) of the menstrual cycle and was continued until estradiol levels were below 60 pg/dL. These protocols were compared with a standard protocol (protocol A). The main outcome of interest was the number of metaphase 2 oocytes retrieved. Results from this study show that the number of mature oocytes retrieved was comparable across the different protocols (14.3±4.6 in the standard protocol versus 13.0±9.1 and 13.2±5.2 in protocols B and C, respectively; values expressed as mean ± standard deviation). The mean number of days needed for a GnRH antagonist to lower estradiol levels, as well as the ongoing pregnancy rates, were also similar when protocols B (stimulation in follicular phase) and C (stimulation on luteal phase) were compared with protocol A (standard stimulation). GnRH antagonists can be effectively used for random-start controlled ovarian hyperstimulation with an ovarian response similar to that of standard protocols, and the antagonists appear suitable for emergency fertility preservation in cancer patients. PMID:25709506

  5. Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548

    PubMed Central

    Ersek, Mary; Turner, Judith A; Cain, Kevin C; Kemp, Carol A

    2004-01-01

    Background Chronic pain is a common and frequently disabling problem in older adults. Clinical guidelines emphasize the need to use multimodal therapies to manage persistent pain in this population. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples. This training includes education about pain as well as instruction and practice in several management techniques, including relaxation, physical exercise, modification of negative thoughts, and goal setting. Few studies have examined the effectiveness of this therapy in older adult samples. Methods/Design This is a randomized, controlled trial to assess the effectiveness of a pain self-management training group intervention, as compared with an education-only control condition. Participants are recruited from retirement communities in the Pacific Northwest of the United States and must be 65 years or older and experience persistent, noncancer pain that limits their activities. The primary outcome is physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes are depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurs by facility to minimize cross-contamination between groups. The target sample size is 273 enrolled, which assuming a 20% attrition rate at 12 months, will provide us with 84% power to detect a moderate effect size of .50 for the primary outcome. Discussion Few studies have investigated the effects of multimodal pain self-management training among older adults. This randomized controlled trial is designed to assess the efficacy of a pain self-management program that incorporates physical and psychosocial pain coping skills among adults in the mid-old to old-old range. PMID:15285783

  6. A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy.

    PubMed

    Klopstock, Thomas; Yu-Wai-Man, Patrick; Dimitriadis, Konstantinos; Rouleau, Jacinthe; Heck, Suzette; Bailie, Maura; Atawan, Alaa; Chattopadhyay, Sandip; Schubert, Marion; Garip, Aylin; Kernt, Marcus; Petraki, Diana; Rummey, Christian; Leinonen, Mika; Metz, Günther; Griffiths, Philip G; Meier, Thomas; Chinnery, Patrick F

    2011-09-01

    Major advances in understanding the pathogenesis of inherited metabolic disease caused by mitochondrial DNA mutations have yet to translate into treatments of proven efficacy. Leber's hereditary optic neuropathy is the most common mitochondrial DNA disorder causing irreversible blindness in young adult life. Anecdotal reports support the use of idebenone in Leber's hereditary optic neuropathy, but this has not been evaluated in a randomized controlled trial. We conducted a 24-week multi-centre double-blind, randomized, placebo-controlled trial in 85 patients with Leber's hereditary optic neuropathy due to m.3460G>A, m.11778G>A, and m.14484T>C or mitochondrial DNA mutations. The active drug was idebenone 900 mg/day. The primary end-point was the best recovery in visual acuity. The main secondary end-point was the change in best visual acuity. Other secondary end-points were changes in visual acuity of the best eye at baseline and changes in visual acuity for both eyes in each patient. Colour-contrast sensitivity and retinal nerve fibre layer thickness were measured in subgroups. Idebenone was safe and well tolerated. The primary end-point did not reach statistical significance in the intention to treat population. However, post hoc interaction analysis showed a different response to idebenone in patients with discordant visual acuities at baseline; in these patients, all secondary end-points were significantly different between the idebenone and placebo groups. This first randomized controlled trial in the mitochondrial disorder, Leber's hereditary optic neuropathy, provides evidence that patients with discordant visual acuities are the most likely to benefit from idebenone treatment, which is safe and well tolerated. PMID:21788663

  7. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    PubMed Central

    Venekamp, Roderick P.; Bonten, Marc J.M.; Rovers, Maroeska M.; Verheij, Theo J.M.; Sachs, Alfred P.E.

    2012-01-01

    Background: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic corticosteroid monotherapy for clinically diagnosed, uncomplicated acute rhinosinusitis. Methods: We conducted a block-randomized, double-blind, placebo-controlled clinical trial at 54 primary care practices (68 family physicians) in the Netherlands between Dec. 30, 2008, and Apr. 28, 2011. Adult patients with clinically diagnosed acute rhinosinusitis were randomly assigned to receive either prednisolone 30 mg/d or placebo for 7 days and asked to complete a symptom diary for 14 days. The primary outcome measure was the proportion of patients with resolution of facial pain or pressure on day 7. Results: Of the 185 patients included in the trial (93 in the treatment group, 92 in the placebo group), 2 withdrew from the study and 9 were excluded from the primary analysis because of incomplete symptom reporting. The remaining 174 patients (88 in the treatment group, 86 in the placebo group) were included in the intention-to-treat analysis. The proportions of patients with resolution of facial pain or pressure on day 7 were 62.5% (55/88) in the prednisolone group and 55.8% (48/86) in the placebo group (absolute risk difference 6.7%, 95% confidence interval −7.9% to 21.2%). The groups were similar with regard to the decrease over time in the proportion of patients with total symptoms (combined symptoms of runny nose, postnasal discharge, nasal congestion, cough and facial pain) and health-related quality of life. Adverse events were mild and did not differ significantly between the groups. Interpretation: Systemic corticosteroid monotherapy had no clinically relevant beneficial effects among patients with clinically diagnosed acute rhinosinusitis. Netherlands Trial Register

  8. A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy.

    PubMed

    Klopstock, Thomas; Yu-Wai-Man, Patrick; Dimitriadis, Konstantinos; Rouleau, Jacinthe; Heck, Suzette; Bailie, Maura; Atawan, Alaa; Chattopadhyay, Sandip; Schubert, Marion; Garip, Aylin; Kernt, Marcus; Petraki, Diana; Rummey, Christian; Leinonen, Mika; Metz, Günther; Griffiths, Philip G; Meier, Thomas; Chinnery, Patrick F

    2011-09-01

    Major advances in understanding the pathogenesis of inherited metabolic disease caused by mitochondrial DNA mutations have yet to translate into treatments of proven efficacy. Leber's hereditary optic neuropathy is the most common mitochondrial DNA disorder causing irreversible blindness in young adult life. Anecdotal reports support the use of idebenone in Leber's hereditary optic neuropathy, but this has not been evaluated in a randomized controlled trial. We conducted a 24-week multi-centre double-blind, randomized, placebo-controlled trial in 85 patients with Leber's hereditary optic neuropathy due to m.3460G>A, m.11778G>A, and m.14484T>C or mitochondrial DNA mutations. The active drug was idebenone 900 mg/day. The primary end-point was the best recovery in visual acuity. The main secondary end-point was the change in best visual acuity. Other secondary end-points were changes in visual acuity of the best eye at baseline and changes in visual acuity for both eyes in each patient. Colour-contrast sensitivity and retinal nerve fibre layer thickness were measured in subgroups. Idebenone was safe and well tolerated. The primary end-point did not reach statistical significance in the intention to treat population. However, post hoc interaction analysis showed a different response to idebenone in patients with discordant visual acuities at baseline; in these patients, all secondary end-points were significantly different between the idebenone and placebo groups. This first randomized controlled trial in the mitochondrial disorder, Leber's hereditary optic neuropathy, provides evidence that patients with discordant visual acuities are the most likely to benefit from idebenone treatment, which is safe and well tolerated.

  9. Ligustrazine for the Treatment of Unstable Angina: A Meta-Analysis of 16 Randomized Controlled Trials

    PubMed Central

    Cao, Suman; Zhao, Wenli; Bu, Huaien; Zhao, Ye; Yu, Chunquan

    2016-01-01

    Ligustrazine is a principal ingredient of chuanxiong. Concerns regarding the evaluation of the effectiveness of ligustrazine in the treatment of UA have resulted in a meta-analysis combined with recent clinical evidence. Seven computer databases that included the China hospital knowledge database (CHKD), Wanfang Med Online, the Chinese medical journal database (CMJD), PubMed, Cochrane, Embase (Ovid), and Medline (Ovid) were systematically searched. We included randomized controlled trials and quasi-randomized controlled trials. Our systematic review identified 16 RCTs that met our eligibility criteria. Ligustrazine combined with conventional medicine was associated with an increased rate of marked improvement in symptoms and an increased rate of marked improvement of ECG compared with conventional Western medicine alone. Additionally, the use of ligustrazine was associated with significant trends in the reduction of the consumption of nitroglycerin and the level of fibrinogen when compared with conventional Western medicine alone. No firm results were found between the intervention and the control method groups in the reduction of the time of onset or the frequency of acute attack angina due to the high level of heterogeneity. In conclusion, our meta-analysis found that ligustrazine was associated with some benefits for people with unstable angina. PMID:27213001

  10. Can orthotic insoles prevent lower limb overuse injuries? A randomized-controlled trial of 228 subjects.

    PubMed

    Mattila, V M; Sillanpää, P J; Salo, T; Laine, H-J; Mäenpää, H; Pihlajamäki, H

    2011-12-01

    Lower limb overuse injuries are common among people who are exposed to physical stress. Orthotic shoe insoles are widely used to prevent lower limb overuse injuries. Here, we conducted a randomized-controlled study to examine whether the use of orthotic insoles prevents lower limb overuse injuries. Participants (n=228) were randomly assigned to use (n=73) or not to use (n=147) orthotic insoles. The insoles were molded to the shape of the foot to provide support during physical activity. The main outcome measure in the present study was the physician-diagnosed lower limb overuse injury. Thirty-four (46.6%) subjects in the insole group were diagnosed with a lower limb overuse injury compared with 56 (38.1%) in the control group (P=0.29) during the 6-month study period. When body mass index and the results of a 12-min running test and muscle strength were adjusted in a Cox's regression model, the hazard ratio for lower limb overuse injury in the insole group was 1.3 (95% confidence intervals: 0.8-2.1) compared with the control group. Use of orthotic insoles was not associated with a decrease in lower limb overuse injuries. Our findings suggest that routine use of orthotic insoles does not prevent physical-stress-related lower limb injuries in healthy young male adults.

  11. Maternal Music Exposure during Pregnancy Influences Neonatal Behaviour: An Open-Label Randomized Controlled Trial

    PubMed Central

    Arya, Ravindra; Chansoria, Maya; Konanki, Ramesh; Tiwari, Dileep K.

    2012-01-01

    Objective. This study evaluated the effect of antenatal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS). Methods. This was a single-centre, randomized, open-label controlled trial. Primigravida mothers aged 19–29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less, were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard antenatal care (intervention arm) or standard care only (control arm). Perinatal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol. The trial is registered with ClinicalTrials.gov (NCT01278329). Results. One hundred and twenty-six newborns in the music group and 134 in the control group were subjected to BNBAS assessment. The infants of mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation (ES 1.13, 95% CI 0.82–1.44, P < 0.0001) and habituation (ES 1.05, 95% CI 0.53–1.57, P = 0.0001). Conclusion. Prenatal music exposure to mother significantly and favourably influences neonatal behaviour. PMID:22518187

  12. Design and implementation of a randomized controlled trial of genomic counseling for patients with chronic disease.

    PubMed

    Sweet, Kevin; Gordon, Erynn S; Sturm, Amy C; Schmidlen, Tara J; Manickam, Kandamurugu; Toland, Amanda Ewart; Keller, Margaret A; Stack, Catharine B; García-España, J Felipe; Bellafante, Mark; Tayal, Neeraj; Embi, Peter; Binkley, Philip; Hershberger, Ray E; Sadee, Wolfgang; Christman, Michael; Marsh, Clay

    2014-01-01

    We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF) or hypertension (HTN), managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC). Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®). OSUWMC patient participants with chronic disease (CD) receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling-active arm, versus web-based only return of results-control arm. Study-specific surveys measure: (1) change in risk perception; (2) knowledge retention; (3) perceived personal control; (4) health behavior change; and, for the active arm (5), overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx) through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices. PMID:24926413

  13. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial.

    PubMed

    Flaugnacco, Elena; Lopez, Luisa; Terribili, Chiara; Montico, Marcella; Zoia, Stefania; Schön, Daniele

    2015-01-01

    There is some evidence for a role of music training in boosting phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development. Poor performance in tasks requiring temporal processing, rhythm perception and sensorimotor synchronization seems to be a crucial factor underlying dyslexia in children. Interestingly, children with dyslexia show deficits in temporal processing, both in language and in music. Within this framework, we test the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia. The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test (ID NCT02316873). After rehabilitation, the music group (N = 24) performed better than the control group (N = 22) in tasks assessing rhythmic abilities, phonological awareness and reading skills. This is the first randomized control trial testing the effect of music training in enhancing phonological and reading abilities in children with dyslexia. The findings show that music training can modify reading and phonological abilities even when these skills are severely impaired. Through the enhancement of temporal processing and rhythmic skills, music might become an important tool in both remediation and early intervention programs.Trial Registration: ClinicalTrials.gov NCT02316873

  14. Ligustrazine for the Treatment of Unstable Angina: A Meta-Analysis of 16 Randomized Controlled Trials.

    PubMed

    Cao, Suman; Zhao, Wenli; Bu, Huaien; Zhao, Ye; Yu, Chunquan

    2016-01-01

    Ligustrazine is a principal ingredient of chuanxiong. Concerns regarding the evaluation of the effectiveness of ligustrazine in the treatment of UA have resulted in a meta-analysis combined with recent clinical evidence. Seven computer databases that included the China hospital knowledge database (CHKD), Wanfang Med Online, the Chinese medical journal database (CMJD), PubMed, Cochrane, Embase (Ovid), and Medline (Ovid) were systematically searched. We included randomized controlled trials and quasi-randomized controlled trials. Our systematic review identified 16 RCTs that met our eligibility criteria. Ligustrazine combined with conventional medicine was associated with an increased rate of marked improvement in symptoms and an increased rate of marked improvement of ECG compared with conventional Western medicine alone. Additionally, the use of ligustrazine was associated with significant trends in the reduction of the consumption of nitroglycerin and the level of fibrinogen when compared with conventional Western medicine alone. No firm results were found between the intervention and the control method groups in the reduction of the time of onset or the frequency of acute attack angina due to the high level of heterogeneity. In conclusion, our meta-analysis found that ligustrazine was associated with some benefits for people with unstable angina. PMID:27213001

  15. Effect of a physical conditioning versus health promotion intervention in dancers: a randomized controlled trial.

    PubMed

    Roussel, Nathalie A; Vissers, Dirk; Kuppens, Kevin; Fransen, Erik; Truijen, Steven; Nijs, Jo; De Backer, Wilfried

    2014-12-01

    Although dancing requires extensive physical exertion, dancers do not often train their physical fitness outside dance classes. Reduced aerobic capacity, lower muscle strength and altered motor control have been suggested as contributing factors for musculoskeletal injuries in dancers. This randomized controlled trial examined whether an intervention program improves aerobic capacity and explosive strength and reduces musculoskeletal injuries in dancers. Forty-four dancers were randomly allocated to a 4-month conditioning (i.e. endurance, strength and motor control training) or health promotion program (educational sessions). Outcome assessment was conducted by blinded assessors. When accounting for differences at baseline, no significant differences were observed between the groups following the intervention, except for the subscale "Pain" of the Short Form 36 Questionnaire (p = 0.03). Injury incidence rate and the proportion of injured dancers were identical in both groups, but dancers following the conditioning program had significant less low back injuries (p = 0.02). Supplementing regular dance training with a 4-month conditioning program does not lead to a significant increase in aerobic capacity or explosive strength in pre-professional dancers compared to a health promotion program without conditioning training, but leads to less reported pain. Further research should explore how additional training may be organized, taking into account the demanding dance schedule of pre-professional dancers. The trial is registered at ClinicalTrials.gov, number NCT01440153. PMID:24951437

  16. Can Inner Peace be Improved by Mindfulness Training: A Randomized Controlled Trial.

    PubMed

    Liu, Xinghua; Xu, Wei; Wang, Yuzheng; Williams, J Mark G; Geng, Yan; Zhang, Qian; Liu, Xin

    2015-08-01

    This article reports a randomized controlled trial to investigate whether mindfulness training can successfully improve inner peace in participants with no known mental disorder. Fifty-seven participants were randomized to either mindfulness training (n = 29) or wait-list control (n = 28). The experience sampling method was used to measure the fleeting momentary experience of inner peace in participants. In addition, we used an experimental approach to assessing ability to focus attention: the Meditation Breath Attention Score, as well as the self-report Five-Facet Mindfulness Questionnaire (FFMQ). Compared with the wait-list control group, mindfulness training led to an increase in scores of inner peace, Meditation Breath Attention Score and FFMQ, using analysis of repeated measures analysis of variance. Change in inner peace was not, however, mediated by changes in self-rated mindfulness (FFMQ) nor by increased attentional focus. The findings provide first evidence suggesting that using mindfulness training improves the participants' inner peace. The focus here was on the immediate effects and future studies need to use follow-up.

  17. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field. PMID:26248094

  18. Effect of a physical conditioning versus health promotion intervention in dancers: a randomized controlled trial.

    PubMed

    Roussel, Nathalie A; Vissers, Dirk; Kuppens, Kevin; Fransen, Erik; Truijen, Steven; Nijs, Jo; De Backer, Wilfried

    2014-12-01

    Although dancing requires extensive physical exertion, dancers do not often train their physical fitness outside dance classes. Reduced aerobic capacity, lower muscle strength and altered motor control have been suggested as contributing factors for musculoskeletal injuries in dancers. This randomized controlled trial examined whether an intervention program improves aerobic capacity and explosive strength and reduces musculoskeletal injuries in dancers. Forty-four dancers were randomly allocated to a 4-month conditioning (i.e. endurance, strength and motor control training) or health promotion program (educational sessions). Outcome assessment was conducted by blinded assessors. When accounting for differences at baseline, no significant differences were observed between the groups following the intervention, except for the subscale "Pain" of the Short Form 36 Questionnaire (p = 0.03). Injury incidence rate and the proportion of injured dancers were identical in both groups, but dancers following the conditioning program had significant less low back injuries (p = 0.02). Supplementing regular dance training with a 4-month conditioning program does not lead to a significant increase in aerobic capacity or explosive strength in pre-professional dancers compared to a health promotion program without conditioning training, but leads to less reported pain. Further research should explore how additional training may be organized, taking into account the demanding dance schedule of pre-professional dancers. The trial is registered at ClinicalTrials.gov, number NCT01440153.

  19. Training pharmacy workers in recognition, management, and prevention of STDs: district-randomized controlled trial.

    PubMed Central

    Garcia, Patricia; Hughes, James; Carcamo, Cesar; Holmes, King K.

    2003-01-01

    OBJECTIVES: To determine the effectiveness of an intervention for pharmacy workers in improving their recognition and management of sexually transmitted disease (STD) syndromes. METHODS: We randomly selected 14 districts (total population nearly 4 million) from the 24 districts of low socioeconomic status in Lima, Peru. We randomly assigned paired districts to receive training and support for management and prevention of STDs or a control intervention about management of diarrhoea. The STD intervention included interactive luncheon seminars on recognition and management of four STD syndromes (urethral discharge, vaginal discharge, genital ulcers, and pelvic inflammatory disease) and STD/HIV prevention counselling; monthly pharmacy visits by "prevention salespersons" who distributed materials that included "STD/HIV prevention packets" containing information, condoms, and cards given to patients for referral of their sex partners; and workshops for physicians on managing patients with STD syndromes referred from pharmacies. Standardized simulated patients visited pharmacies in intervention and control districts at one, three, and six months after training to assess outcomes. FINDINGS: Standardized simulated patients reported significantly better recognition and management (appropriate antimicrobial regimens provided for discharge syndromes and referral to specially trained physicians for genital ulcers or pelvic inflammatory disease) by pharmacy workers of all four STD syndromes. They also reported significantly more frequent recommendations for use of condoms and treatment of partners at pharmacies in intervention districts than in control districts (by "intention-to-train" analyses, P<0.05 for 47/48 primary outcome comparisons). CONCLUSION: Training was feasible and effectively improved pharmacy workers' practices. PMID:14758407

  20. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    PubMed Central

    Ferreira, Giovanni E.; Barreto, Rodrigo G. P.; Robinson, Caroline C.; Plentz, Rodrigo D. M.; Silva, Marcelo F.

    2016-01-01

    ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Results Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. Conclusion GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions. PMID:27437710

  1. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial.

    PubMed

    Flaugnacco, Elena; Lopez, Luisa; Terribili, Chiara; Montico, Marcella; Zoia, Stefania; Schön, Daniele

    2015-01-01

    There is some evidence for a role of music training in boosting phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development. Poor performance in tasks requiring temporal processing, rhythm perception and sensorimotor synchronization seems to be a crucial factor underlying dyslexia in children. Interestingly, children with dyslexia show deficits in temporal processing, both in language and in music. Within this framework, we test the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia. The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test (ID NCT02316873). After rehabilitation, the music group (N = 24) performed better than the control group (N = 22) in tasks assessing rhythmic abilities, phonological awareness and reading skills. This is the first randomized control trial testing the effect of music training in enhancing phonological and reading abilities in children with dyslexia. The findings show that music training can modify reading and phonological abilities even when these skills are severely impaired. Through the enhancement of temporal processing and rhythmic skills, music might become an important tool in both remediation and early intervention programs.Trial Registration: ClinicalTrials.gov NCT02316873 PMID:26407242

  2. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  3. Replicating ¡Cuídate!: 6-Month Impact Findings of a Randomized Controlled Trial

    PubMed Central

    Layzer, Carolyn; Layzer, Jean; Price, Cristofer; Juras, Randall; Blocklin, Michelle; Mendez, Jacqueline

    2016-01-01

    Objectives. To test whether ¡Cuídate!, a program culturally adapted for Hispanic youths, affects sexual risk behavior. Methods. We evaluated 3 replications of ¡Cuídate! in California, Arizona, and Massachusetts in a randomized controlled trial (registry no. NCT02540304) in which 2169 primarily Hispanic participants were randomly assigned to an intervention (n = 1326) or a control (n = 870) group. Youths were surveyed at baseline (September 2012–April 2014) and 6 months postbaseline (March 2013–October 2014). We estimated pooled and subgroup impacts using a regression framework with baseline covariates to increase statistical precision (1216 youths analyzed in the treatment group, 806 analyzed in the control group). Results. We found no impacts on the study’s primary outcomes of recent sexual activity or recent unprotected sexual activity. However, ¡Cuídate! improved knowledge (10%–20% increase; P < .001), attitudes (effect size = .24; P < .001), and skills (effect size = .14; P = .002). Exploratory subgroup analyses suggest potentially problematic effects for some groups. Conclusions. Findings suggest that ¡Cuídate! was effective in improving youths’ knowledge and attitudes. However, after 6 months, these changes did not translate to improvements in reported sexual risk behaviors. PMID:27689498

  4. Zonisamide for Bipolar Depression: A Randomized, Double Blind, Placebo-Controlled, Adjunctive Trial

    PubMed Central

    Dauphinais, Deborah; Knable, Michael; Rosenthal, Joshua; Polanski, Mark; Rosenthal, Norman

    2011-01-01

    Objective This is the first multicenter, double blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of adjunctive zonisamide for the treatment of bipolar depression. Experimental design One hundred two patients with bipolar disorder, type I or II in the depressed phase of illness were randomized to either adjunctive zonisamide or placebo. The study consisted of three phases, a 7 to 30 day screening and stabilization phase, 6 weeks of blinded treatment and a 1 to 3 week discontinuation phase. MADRS score was the primary outcome variable. Secondary outcome measures included the YMRS, CGI-S, CGI-I, Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and an a priori analysis of response and remission. Metabolic parameters including weight, waist-hip ratio, body mass index, fasting glucose, cholesterol and triglyceride levels were also evaluated. Side effects were measured using the SAFTEE. Principal observations There were no statistically significant differences in response between subjects treated with adjunctive zonisamide vs. placebo controls for the primary or secondary outcome measures. There were also no differences between the groups with regard to response rate or remission rate. Conclusions In contrast to preliminary open label studies that suggested a role for zonisamide in bipolar depression, we could not confirm these results in a large double blind controlled study.

  5. Music Training Increases Phonological Awareness and Reading Skills in Developmental Dyslexia: A Randomized Control Trial

    PubMed Central

    Flaugnacco, Elena; Lopez, Luisa; Terribili, Chiara; Montico, Marcella; Zoia, Stefania; Schön, Daniele

    2015-01-01

    There is some evidence for a role of music training in boosting phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development. Poor performance in tasks requiring temporal processing, rhythm perception and sensorimotor synchronization seems to be a crucial factor underlying dyslexia in children. Interestingly, children with dyslexia show deficits in temporal processing, both in language and in music. Within this framework, we test the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia. The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test (ID NCT02316873). After rehabilitation, the music group (N = 24) performed better than the control group (N = 22) in tasks assessing rhythmic abilities, phonological awareness and reading skills. This is the first randomized control trial testing the effect of music training in enhancing phonological and reading abilities in children with dyslexia. The findings show that music training can modify reading and phonological abilities even when these skills are severely impaired. Through the enhancement of temporal processing and rhythmic skills, music might become an important tool in both remediation and early intervention programs. Trial Registration ClinicalTrials.gov NCT02316873 PMID:26407242

  6. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials

    PubMed Central

    Kim, Sang-Dol

    2016-01-01

    [Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

  7. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials.

    PubMed

    Kim, Sang-Dol

    2016-07-01

    [Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

  8. Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials.

    PubMed

    Stanworth, S J; Brunskill, S J; Hyde, C J; McClelland, D B L; Murphy, M F

    2004-07-01

    Summary Randomized controlled trials of good quality are a recognized means to robustly assess the efficacy of interventions in clinical practice. A systematic identification and appraisal of all randomized trials involving fresh frozen plasma (FFP) has been undertaken in parallel to the drafting of the updated British Committee for Standards in Haematology guidelines on the use of FFP. A total of 57 trials met the criteria for inclusion in the review. Most clinical uses of FFP, currently recommended by practice guidelines, are not supported by evidence from randomized trials. In particular, there is little evidence for the effectiveness of the prophylactic use of FFP. Many published trials on the use of FFP have enrolled small numbers of patients, and provided inadequate information on the ability of the trial to detect meaningful differences in outcomes between the two patient groups. Other concerns about the design of the trials include the dose of FFP used, and the potential for bias. No studies have taken adequate account of the extent to which adverse effects might negate the clinical benefits of treatment with FFP. There is a need to consider how best to develop new trials to determine the efficacy of FFP in different clinical scenarios to provide the evidence base to support national guidelines for transfusion practice. Trials of modified FFP (e.g. pathogen inactivated) are of questionable value when there is little evidence that the standard product is an effective treatment. PMID:15198745

  9. Controlled random search technique for estimation of convective heat transfer coefficient

    NASA Astrophysics Data System (ADS)

    Mehta, R. C.; Tiwari, S. B.

    2007-09-01

    This paper is concerned with a method for solving inverse heat conduction problem. The method is based on the controlled random search (CRS) technique in conjunction with modified Newton-Raphson method. The random search procedure does not need the computation of derivative of the function to be evaluated. Therefore, it is independent of the calculation of the sensitivity coefficient for nonlinear parameter estimation. The algorithm does not depend on the future-temperature information and can predict convective heat transfer coefficient with random errors in the input temperature data. The technique is first validated against an analytical solution of heat conduction equation for a typical rocket nozzle. Comparison with an earlier analysis of inverse heat conduction problem of a similar experiment shows that the present method provides solutions, which are fully consistent with the earlier results. Once validated, the technique is used to investigate another estimation of heat transfer coefficient for an experiment of short duration, high heating rate, and employing indepth temperature measurement. The CRS procedure, in conjunction with modified Newton-Raphson method, is quite useful in estimating the value of the convective heat-transfer coefficient from the measured transient temperature data on the outer surface or imbedded thermocouple inside the rocket nozzle. Some practical examples are illustrated, which demonstrate the stability and accuracy of the method to predict the surface heat flux.

  10. Noninvasive Ventilation for Preterm Twin Neonates with Respiratory Distress Syndrome: A Randomized Controlled Trial

    PubMed Central

    Chen, Long; Wang, Li; Li, Jie; Wang, Nan; Shi, Yuan

    2015-01-01

    Noninvasive ventilation has been proven to be effective strategies for reducing the need for endotracheal ventilation in preterm infant with respiratory distress syndrome (RDS), however the best option needs to be further determined. A single center, paired design, randomized, controlled trial was conducted between Jan 2011 and July 2014. Preterm twins with RDS were included. One of a pair was randomized to NIPPV, while another to NCPAP. Surfactant was administrated as rescue treatment. The primary outcome was the need for endotracheal ventilation. The secondary outcomes were the complications. 143 pairs were randomized and 129 pairs finished the trial. The rates of endotracheal ventilation did not differ significantly between NIPPV and NCPAP groups (11.9% vs 19.6%, P = 0.080). This difference was not observed in the subgroup of infants who received surfactant therapy (11.1% vs 19.7%, P = 0.087). No secondary outcomes also differed significantly between the two groups. NIPPV did not result in a significantly lower incidence of intubation as compared with NCPAP in preterm twins with RDS. PMID:26399752

  11. An Intervention To Reduce Postpartum Depressive Symptoms: A Randomized Controlled Trial

    PubMed Central

    Howell, Elizabeth A; Bodnar-Deren, Susan; Balbierz, Amy; Loudon, Holly; Mora, Pablo A.; Zlotnick, Caron; Wang, Jason; Leventhal, Howard

    2013-01-01

    Depressive symptoms and depression are a common complication of childbirth and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high income mothers in a second randomized trial. Mothers in the intervention arm received a 2-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3-weeks, 3-months, and 6-months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum were unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention vs. enhanced usual care post hospitalization: 3-weeks (6.0 % vs. 5.6%, p=.83), 3-months (5.1% vs. 6.5%, p=.53) and 6-months (3.6% vs. 4.6%, p=.53). PMID:24019052

  12. Accelerated Hepatitis B Vaccine Schedule among Drug Users – A Randomized Controlled Trial

    PubMed Central

    Hwang, Lu-Yu; Grimes, Carolyn Z.; Tran, Thanh Quoc; Clark, April; Xia, Rui; Lai, Dejian; Troisi, Catherine; Williams, Mark

    2010-01-01

    Background Hepatitis B vaccine provides a model for improving uptake and completion of multi-dose vaccinations in the drug-using community. Methods DASH project conducted randomized controlled trial among not-in-treatment current drug users in two urban neighborhoods. Neighborhoods were cluster-randomized to receive a standard (HIV information) or enhanced (HBV vaccine acceptance/adherence) behavioral intervention; participants within clusters were randomized to a standard (0, 1, 6 mo) or accelerated (0, 1, 2 mo) vaccination schedule. Outcomes were completion of three-dose vaccine and HBV seroprotection. Results Of those screening negative for HIV/HBV, 77% accepted HB vaccination and 75% of those received all 3 doses. Injecting drug users (IDUs) on the accelerated schedule were significantly more likely to receive 3 doses (76%) than those on the standard schedule (66%, p=.04), although for drug users as a whole the adherence was 77% and 73%. No difference in adherence was observed between behavioral intervention groups. Predictors of adherence were older age, African American race, stable housing, and alcohol use. Cumulative HBV seroprotection (≥10 mIU/mL) was gained by 12 months by 65% of those completing. Seroprotection at 6 months was greater for the accelerated schedule group. Conclusions The accelerated vaccine schedule improves hepatitis B vaccination adherence among IDU. PMID:20936979

  13. The effectiveness of breakfast recommendations on weight loss: a randomized controlled trial123

    PubMed Central

    Dhurandhar, Emily J; Dawson, John; Alcorn, Amy; Larsen, Lesli H; Thomas, Elizabeth A; Cardel, Michelle; Bourland, Ashley C; Astrup, Arne; St-Onge, Marie-Pierre; Hill, James O; Apovian, Caroline M; Shikany, James M; Allison, David B

    2014-01-01

    Background: Breakfast is associated with lower body weight in observational studies. Public health authorities commonly recommend breakfast consumption to reduce obesity, but the effectiveness of adopting these recommendations for reducing body weight is unknown. Objective: We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting. Design: We conducted a multisite, 16-wk, 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [body mass index (in kg/m2) between 25 and 40] aged 20–65 y. Our primary outcome was weight change. We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [no breakfast (NB)]. Randomization was stratified by prerandomization breakfast eating habits. A total of 309 participants were randomly assigned. Results: A total of 283 of the 309 participants who were randomly assigned completed the intervention. Treatment assignment did not have a significant effect on weight loss, and there was no interaction between initial breakfast eating status and treatment. Among skippers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.71 ± 1.16, −0.76 ± 1.26, and −0.61 ± 1.18 kg for the control, breakfast, and NB groups, respectively. Among breakfast consumers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.53 ± 1.16, −0.59 ± 1.06, and −0.71 ± 1.17 kg for the control, breakfast, and NB groups, respectively. Self-reported compliance with the recommendation was 93.6% for the breakfast group and 92.4% for the NB group. Conclusions: A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits, but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who

  14. How to Measure Motivational Interviewing Fidelity in Randomized Controlled Trials: Practical Recommendations.

    PubMed

    Jelsma, Judith G M; Mertens, Vera-Christina; Forsberg, Lisa; Forsberg, Lars

    2015-07-01

    Many randomized controlled trials in which motivational interviewing (MI) is a key intervention make no provision for the assessment of treatment fidelity. This methodological shortcoming makes it impossible to distinguish between high- and low-quality MI interventions, and, consequently, to know whether MI provision has contributed to any intervention effects. This article makes some practical recommendations for the collection, selection, coding and reporting of MI fidelity data, as measured using the Motivational Interviewing Treatment Integrity Code. We hope that researchers will consider these recommendations and include MI fidelity measures in future studies.

  15. Randomized, Controlled Trial of a Comprehensive Program for Young Students with Autism Spectrum Disorder.

    PubMed

    Young, Helen E; Falco, Ruth A; Hanita, Makoto

    2016-02-01

    This randomized, controlled trial, comparing the Comprehensive Autism Program (CAP) and business as usual programs, studied outcomes for 3-5 year old students with autism spectrum disorder (ASD). Participants included 84 teachers and 302 students with ASD and their parents. CAP utilized specialized curricula and training components to implement specific evidence-based practices both at school and home. A comprehensive set of outcome areas was studied. Hierarchical linear modeling was used to estimate the treatment impact. CAP had small positive impacts on the students' receptive language (effect size of .13) and on their social skills as rated by teachers (effect size of .19). Treatment effects were moderated by severity of ASD.

  16. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    PubMed

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto

    2014-03-01

    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety. PMID:23362335

  17. Screening Obstetric Ultrasound Training for a Five-Country Cluster Randomized Controlled Trial

    PubMed Central

    Nathan, Robert; Swanson, Jonathan; Marks, William; Goldsmith, Nicole; Vance, Cheryl; Sserwanga, Brian; Swanson, David; McClure, Elizabeth M.; Franklin, Holly; Mirza, Waseem; Mwenechanya, Musaku; Muyodi, David; Figuero, Lester; Bolamba, Victor Lokomba; Goldenberg, Robert L.

    2015-01-01

    With decreased equipment cost, provision of ultrasound is now feasible in some low resource settings. Screening obstetric ultrasound may identify potential pregnancy complications and with this knowledge, allow women to plan to deliver at the appropriate level of care. In this paper we describe a ten-day course with quality assurance activities to train ultrasound-naïve non-physician healthcare professionals at mid-level health facilities to perform screening obstetric ultrasound. Those trained will participate in a cluster-randomized controlled trial to assess the impact of screening obstetric ultrasound on maternal and newborn outcomes. PMID:25415862

  18. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    PubMed

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto

    2014-03-01

    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety.

  19. Training infection control and hospital hygiene professionals in Europe, 2010: agreed core competencies among 33 European countries.

    PubMed

    Brusaferro, S; Cookson, B; Kalenic, S; Cooper, T; Fabry, J; Gallagher, R; Hartemann, P; Mannerquist, K; Popp, W; Privitera, G; Ruef, C; Viale, P; Coiz, F; Fabbro, E; Suetens, C; Varela Santos, C

    2014-12-11

    The harmonisation of training programmes for infection control and hospital hygiene (IC/HH) professionals in Europe is a requirement of the Council recommendation on patient safety. The European Centre for Disease Prevention and Control commissioned the 'Training Infection Control in Europe' project to develop a consensus on core competencies for IC/HH professionals in the European Union (EU). Core competencies were drafted on the basis of the Improving Patient Safety in Europe (IPSE) project's core curriculum (CC), evaluated by questionnaire and approved by National Representatives (NRs) for IC/HH training. NRs also re-assessed the status of IC/HH training in European countries in 2010 in comparison with the situation before the IPSE CC in 2006. The IPSE CC had been used to develop or update 28 of 51 IC/HH courses. Only 10 of 33 countries offered training and qualification for IC/HH doctors and nurses. The proposed core competencies are structured in four areas and 16 professional tasks at junior and senior level. They form a reference for standardisation of IC/HH professional competencies and support recognition of training initiatives.

  20. Randomized Controlled Trials to Define Viral Load Thresholds for Cytomegalovirus Pre-Emptive Therapy

    PubMed Central

    Griffiths, Paul D.; Rothwell, Emily; Raza, Mohammed; Wilmore, Stephanie; Doyle, Tomas; Harber, Mark; O’Beirne, James; Mackinnon, Stephen; Jones, Gareth; Thorburn, Douglas; Mattes, Frank; Nebbia, Gaia; Atabani, Sowsan; Smith, Colette; Stanton, Anna; Emery, Vincent C.

    2016-01-01

    Background To help decide when to start and when to stop pre-emptive therapy for cytomegalovirus infection, we conducted two open-label randomized controlled trials in renal, liver and bone marrow transplant recipients in a single centre where pre-emptive therapy is indicated if viraemia exceeds 3000 genomes/ml (2520 IU/ml) of whole blood. Methods Patients with two consecutive viraemia episodes each below 3000 genomes/ml were randomized to continue monitoring or to immediate treatment (Part A). A separate group of patients with viral load greater than 3000 genomes/ml was randomized to stop pre-emptive therapy when two consecutive levels less than 200 genomes/ml (168 IU/ml) or less than 3000 genomes/ml were obtained (Part B). For both parts, the primary endpoint was the occurrence of a separate episode of viraemia requiring treatment because it was greater than 3000 genomes/ml. Results In Part A, the primary endpoint was not significantly different between the two arms; 18/32 (56%) in the monitor arm had viraemia greater than 3000 genomes/ml compared to 10/27 (37%) in the immediate treatment arm (p = 0.193). However, the time to developing an episode of viraemia greater than 3000 genomes/ml was significantly delayed among those randomized to immediate treatment (p = 0.022). In Part B, the primary endpoint was not significantly different between the two arms; 19/55 (35%) in the less than 200 genomes/ml arm subsequently had viraemia greater than 3000 genomes/ml compared to 23/51 (45%) among those randomized to stop treatment in the less than 3000 genomes/ml arm (p = 0.322). However, the duration of antiviral treatment was significantly shorter (p = 0.0012) in those randomized to stop treatment when viraemia was less than 3000 genomes/ml. Discussion The results illustrate that patients have continuing risks for CMV infection with limited time available for intervention. We see no need to alter current rules for stopping or starting pre-emptive therapy. PMID:27684379

  1. Apps for IMproving FITness and Increasing Physical Activity Among Young People: The AIMFIT Pragmatic Randomized Controlled Trial

    PubMed Central

    Jiang, Yannan; Whittaker, Robyn; Maddison, Ralph

    2015-01-01

    Background Given the global prevalence of insufficient physical activity (PA), effective interventions that attenuate age-related decline in PA levels are needed. Mobile phone interventions that positively affect health (mHealth) show promise; however, their impact on PA levels and fitness in young people is unclear and little is known about what makes a good mHealth app. Objective The aim was to determine the effects of two commercially available smartphone apps (Zombies, Run and Get Running) on cardiorespiratory fitness and PA levels in insufficiently active healthy young people. A second aim was to identify the features of the app design that may contribute to improved fitness and PA levels. Methods Apps for IMproving FITness (AIMFIT) was a 3-arm, parallel, randomized controlled trial conducted in Auckland, New Zealand. Participants were recruited through advertisements in electronic mailing lists, local newspapers, flyers posted in community locations, and presentations at schools. Eligible young people aged 14-17 years were allocated at random to 1 of 3 conditions: (1) use of an immersive app (Zombies, Run), (2) use of a nonimmersive app (Get Running), or (3) usual behavior (control). Both smartphone apps consisted of a fully automated 8-week training program designed to improve fitness and ability to run 5 km; however, the immersive app featured a game-themed design and narrative. Intention-to-treat analysis was performed using data collected face-to-face at baseline and 8 weeks, and all regression models were adjusted for baseline outcome value and gender. The primary outcome was cardiorespiratory fitness, objectively assessed as time to complete the 1-mile run/walk test at 8 weeks. Secondary outcomes were PA levels (accelerometry and self-reported), enjoyment, psychological need satisfaction, self-efficacy, and acceptability and usability of the apps. Results A total of 51 participants were randomized to the immersive app intervention (n=17), nonimmersive

  2. Evaluation of the UP4FUN Intervention: A Cluster Randomized Trial to Reduce and Break Up Sitting Time in European 10-12-Year-Old Children

    PubMed Central

    Vik, Frøydis N.; Lien, Nanna; Berntsen, Sveinung; De Bourdeaudhuij, Ilse; Grillenberger, Monika; Manios, Yannis; Kovacs, Eva; Chinapaw, Mai J. M.; Brug, Johannes; Bere, Elling

    2015-01-01

    Background The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time), and breaking up sitting time in school among 10–12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects. Methodology/Principal Findings A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1–2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and total sedentary time and breaking up sitting time by accelerometry. The effect of the intervention on these behaviors was evaluated by multilevel regression analyses. All analyses were adjusted for baseline values and gender. Significance level was p≤0.01. No significant intervention effects were observed, neither for self-reported TV/DVD or computer/game console time, nor for accelerometer-assessed total sedentary time and number of breaks in sitting time. The intervention group, however, reported more positive attitudes towards (β = 0.25 (95% CI 0.11, 0.38)) and preferences/liking for (β = 0.20 (95% CI 0.08, 0.32)) breaking up sitting time than the control group. Conclusions/Significance No significant intervention effect on self-reported screen time or accelerometer-assessed sedentary time or breaks in sitting time was observed, but positive effects on beliefs regarding breaking up sitting time were found in favor of the intervention group. Overall, these results do not warrant wider dissemination of the present UP4FUN intervention. Trial Registration International Standard Randomized Controlled Trial Number Registry ISRCTN34562078 PMID:25826704

  3. The Ethics of Randomized Controlled Trials in Social Settings: Can Social Trials Be Scientifically Promising and Must There Be Equipoise?

    ERIC Educational Resources Information Center

    Fives, Allyn; Russell, Daniel W.; Canavan, John; Lyons, Rena; Eaton, Patricia; Devaney, Carmel; Kearns, Norean; O'Brien, Aoife

    2015-01-01

    In a randomized controlled trial (RCT), treatments are assigned randomly and treatments are withheld from participants. Is it ethically permissible to conduct an RCT in a social setting? This paper addresses two conditions for justifying RCTs: that there should be a state of equipoise and that the trial should be scientifically promising.…

  4. Interventions to Improve Medication Adherence among Older Adults: Meta-Analysis of Adherence Outcomes among Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Ruppar, Todd M.; Mehr, David R.; Russell, Cynthia L.

    2009-01-01

    Purpose: This study investigated the effectiveness of interventions to improve medication adherence (MA) in older adults. Design and Methods: Meta-analysis was used to synthesize results of 33 published and unpublished randomized controlled trials. Random-effects models were used to estimate overall mean effect sizes (ESs) for MA, knowledge,…

  5. A Facility Specialist Model for Improving Retention of Nursing Home Staff: Results from a Randomized, Controlled Study

    ERIC Educational Resources Information Center

    Pillemer, Karl; Meador, Rhoda; Henderson, Charles, Jr.; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

    2008-01-01

    Purpose: This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. Design and Methods: We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and…

  6. Cognitive-Behavioral Treatment for Panic Disorder with Agoraphobia: A Randomized, Controlled Trial and Cost-Effectiveness Analysis

    ERIC Educational Resources Information Center

    Roberge, Pasquale; Marchand, Andre; Reinharz, Daniel; Savard, Pierre

    2008-01-01

    A randomized, controlled trial was conducted to examine the cost-effectiveness of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants were randomly assigned to standard (n = 33), group (n = 35), and brief (n = 32) treatment conditions. Results show significant clinical and statistical improvement…

  7. Mechanism of Developmental Change in the PLAY Project Home Consultation Program: Evidence from a Randomized Control Trial

    ERIC Educational Resources Information Center

    Mahoney, Gerald; Solomon, Richard

    2016-01-01

    This investigation is a secondary analysis of data from a randomized control trial of the PLAY Home Consultation Intervention Program which was conducted with 112 preschool children with Autism Spectrum Disorders and their parents (Solomon et al. in "J Dev Behav Pediatr" 35:475-485, 2014). Subjects were randomly assigned to either a…

  8. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

    2007-01-01

    We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

  9. Implementing Quality Control on a Random Number Stream to Improve a Stochastic Weather Generator

    Technology Transfer Automated Retrieval System (TEKTRAN)

    For decades stochastic modelers have used computerized random number generators to produce random numeric sequences fitting a specified statistical distribution. Unfortunately, none of the random number generators we tested satisfactorily produced the target distribution. The result is generated d...

  10. Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol

    PubMed Central

    2013-01-01

    Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the

  11. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study)

    PubMed Central

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

    2016-01-01

    To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of “less tight” (target diastolic blood pressure [dBP] 100 mm Hg) versus “tight” control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×109/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×109/L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence. Clinical Trial Registration— URL: http://pre-empt.cfri.ca/. Unique identifier: ISRCTN

  12. Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial

    PubMed Central

    McGraw, Thomas

    2016-01-01

    Purpose To evaluate the safety and tolerability of aqueous solution concentrate (ASC) of polyethylene glycol (PEG) 3350 in patients with functional constipation. Patients and methods The patients who met Rome III diagnostic criteria for functional constipation were randomized in this multicenter, randomized, placebo-controlled, single-blind study to receive once daily dose of PEG 3350 (17 g) ASC or placebo solution for 14 days. The study comprised a screening period (visit 1), endoscopy procedure (visits 2 and 3), and followup telephone calls 30 days post-treatment. Safety end points included adverse events (AEs), clinical laboratory evaluations, vital signs, and others. The primary end points were the proportion of patients with abnormalities of the oral and esophageal mucosa, detected by visual and endoscopic examination of the oral cavity and esophagus, respectively, compared with placebo. A secondary objective was to compare the safety and tolerability of ASC by evaluating AEs or adverse drug reactions. Results A total of 65 patients were enrolled in this study, 31 were randomized to PEG 3350 ASC and 34 were randomized to placebo, of which 62 patients completed the study. No patients in either group showed abnormalities in inflammation of the oral mucosa during visit 2 (before treatment) or visit 3 (after treatment). Fewer abnormalities of the esophageal mucosa were observed in the PEG 3350 ASC group than in the placebo group on visit 3, with no significant difference in the proportion of abnormalities between the treatment groups. Overall, 40 treatment-emergent AEs were observed in 48.4% of patients treated with PEG 3350 ASC, and 41 treatment-emergent AEs were observed in 55.9% of patients treated with placebo – nonsignificant difference of −7.5% (95% CI: −21.3, 6.3) between treatment groups. No serious AEs or deaths were reported, and no patient discontinued because of an AE. Conclusion PEG 3350 ASC is safe and well tolerated in patients with functional

  13. Patients’ ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial

    PubMed Central

    Umasunthar, T; Procktor, A; Hodes, M; Smith, J G; Gore, C; Cox, H E; Marrs, T; Hanna, H; Phillips, K; Pinto, C; Turner, P J; Warner, J O; Boyle, R J

    2015-01-01

    Background Previous work has shown patients commonly misuse adrenaline autoinjectors (AAI). It is unclear whether this is due to inadequate training, or poor device design. We undertook a prospective randomized controlled trial to evaluate ability to administer adrenaline using different AAI devices. Methods We allocated mothers of food-allergic children prescribed an AAI for the first time to Anapen or EpiPen using a computer-generated randomization list, with optimal training according to manufacturer's instructions. After one year, participants were randomly allocated a new device (EpiPen, Anapen, new EpiPen, JEXT or Auvi-Q), without device-specific training. We assessed ability to deliver adrenaline using their AAI in a simulated anaphylaxis scenario six weeks and one year after initial training, and following device switch. Primary outcome was successful adrenaline administration at six weeks, assessed by an independent expert. Secondary outcomes were success at one year, success after switching device, and adverse events. Results We randomized 158 participants. At six weeks, 30 of 71 (42%) participants allocated to Anapen and 31 of 73 (43%) participants allocated to EpiPen were successful – RR 1.00 (95% CI 0.68–1.46). Success rates at one year were also similar, but digital injection was more common at one year with EpiPen (8/59, 14%) than Anapen (0/51, 0%, P = 0.007). When switched to a new device without specific training, success rates were higher with Auvi-Q (26/28, 93%) than other devices (39/80, 49%; P < 0.001). Conclusions AAI device design is a major determinant of successful adrenaline administration. Success rates were low with several devices, but were high using the audio-prompt device Auvi-Q. PMID:25850463

  14. Taekwondo training improves sensory organization and balance control in children with developmental coordination disorder: a randomized controlled trial.

    PubMed

    Fong, Shirley S M; Tsang, William W N; Ng, Gabriel Y F

    2012-01-01

    Children with developmental coordination disorder (DCD) have poorer postural control and are more susceptible to falls and injuries than their healthy counterparts. Sports training may improve sensory organization and balance ability in this population. This study aimed to evaluate the effects of three months of Taekwondo (TKD) training on the sensory organization and standing balance of children with DCD. It is a randomized controlled trial. Forty-four children with DCD (mean age: 7.6±1.3 years) and 18 typically developing children (mean age: 7.2±1.0 years) participated in the study. Twenty-one children with DCD were randomly selected to undergo daily TKD training for three months (1 h per day). Twenty-three children with DCD and 18 typically developing children received no training as controls. Sensory organization and standing balance were evaluated using a sensory organization test (SOT) and unilateral stance test (UST), respectively. Repeated measures MANCOVA showed a significant group by time interaction effect. Post hoc analysis demonstrated that improvements in the vestibular ratio (p=0.003) and UST sway velocity (p=0.007) were significantly greater in the DCD-TKD group than in the DCD-control group. There was no significant difference in the average vestibular ratio or UST sway velocity between the DCD-TKD and normal-control group after three months of TKD training (p>0.05). No change was found in the somatosensory ratio after TKD training (p>0.05). Significant improvements in visual ratios, vestibular ratios, SOT composite scores and UST sway velocities were also observed in the DCD-TKD group after training (p≤0.01). Three months of daily TKD training can improve sensory organization and standing balance for children with DCD. Clinicians can suggest TKD as a therapeutic leisure activity for this population. PMID:22093652

  15. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial.

    PubMed

    Emerson, John F; Welch, Madelyn; Rossman, Whitney E; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2016-01-01

    Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a

  16. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial.

    PubMed

    Emerson, John F; Welch, Madelyn; Rossman, Whitney E; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2015-12-22

    Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a

  17. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    PubMed Central

    Emerson, John F.; Welch, Madelyn; Rossman, Whitney E.; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G.; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2015-01-01

    Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a

  18. Cognitive Behavioral Therapy for Insomnia in Posttraumatic Stress Disorder: A Randomized Controlled Trial

    PubMed Central

    Talbot, Lisa S.; Maguen, Shira; Metzler, Thomas J.; Schmitz, Martha; McCaslin, Shannon E.; Richards, Anne; Perlis, Michael L.; Posner, Donn A.; Weiss, Brandon; Ruoff, Leslie; Varbel, Jonathan; Neylan, Thomas C.

    2014-01-01

    Study Objectives: Examine whether cognitive behavioral therapy for insomnia (CBT-I) improves sleep in posttraumatic stress disorder (PTSD) as well as nightmares, nonsleep PTSD symptoms, depression symptoms, and psychosocial functioning. Design: Randomized controlled trial with two arms: CBT-I and monitor-only waitlist control. Setting: Department of Veterans Affairs (VA) Medical Center. Participants: Forty-five adults (31 females: [mean age 37 y (22-59 y)] with PTSD meeting research diagnostic criteria for insomnia, randomly assigned to CBT-I (n = 29; 22 females) or monitor-only waitlist control (n = 16; nine females). Interventions: Eight-session weekly individual CBT-I delivered by a licensed clinical psychologist or a board-certified psychiatrist. Measurements and Results: Measures included continuous monitoring of sleep with diary and actigraphy; prepolysomnography and postpolysomnography and Clinician-Administered PTSD Scale (CAPS); and pre, mid, and post self-report questionnaires, with follow-up of CBT-I participants 6 mo later. CBT-I was superior to the waitlist control condition in all sleep diary outcomes and in polysomnography-measured total sleep time. Compared to waitlist participants, CBT-I participants reported improved subjective sleep (41% full remission versus 0%), disruptive nocturnal behaviors (based on the Pittsburgh Sleep Quality Index-Addendum), and overall work and interpersonal functioning. These effects were maintained at 6-mo follow-up. Both CBT-I and waitlist control participants reported reductions in PTSD symptoms and CAPS-measured nightmares. Conclusions: Cognitive behavioral therapy for insomnia (CBT-I) improved sleep in individuals with posttraumatic stress disorder, with durable gains at 6 mo. Overall psychosocial functioning improved following CBT-I. The initial evidence regarding CBT-I and nightmares is promising but further research is needed. Results suggest that a comprehensive approach to treatment of posttraumatic stress

  19. Effectiveness of a pharmacist-led drug counseling on enhancing antihypertensive adherence and blood pressure control: a randomized controlled trial.

    PubMed

    Wong, Martin C S; Liu, Kirin Q L; Wang, Harry H X; Lee, Catherine L S; Kwan, Mandy W M; Lee, Ken W S; Cheung, Yu; Lee, Gabrielle K Y; Morisky, Donald E; Griffiths, Sian M

    2013-07-01

    Adherence to antihypertensive medications represents a crucial success factor for optimal blood pressure (BP) control in clinical practice. This study evaluated whether an additional pharmacist-led medication counseling could achieve better optimal BP control and enhance compliance. In a designated family clinic in a region with similar resident characteristics to Hong Kong, patients taking ≥ one antihypertensive agent with suboptimal compliance were randomly allocated to a brief 3-minute drug advice (control; n = 161) or pharmacist counseling (intervention; n = 113). The two groups were compared by repeated measure ANOVA at 3-months and 6-months with BP control and medication compliance as outcome variables, respectively. The proportions of patients having optimal compliance increased from 0% to 41.1% at 3 months and 61.9% at 6 months (P < 0.001). The proportion of patients having optimal BP control improved from 64.1% at baseline to 74.0% at 3 months and 74.5% at 6 months (P = 0.023). There were no significant differences between the two groups in the changes of BP control and compliance levels. This study implied that even a brief 3-minute drug advice might lead to improved BP levels among patients on antihypertensive medications in general practice, but did not demonstrate additional effects by pharmacist counseling.

  20. Randomized Controlled Trial of BASICS for Heavy Drinking Mandated and Volunteer Undergraduates: 12-Month Outcomes

    PubMed Central

    Terlecki, Meredith A.; Buckner, Julia D.; Larimer, Mary E.; Copeland, Amy L.

    2014-01-01

    This is the first randomized trial testing whether heavy drinking undergraduates mandated to the Brief Alcohol Screening and Intervention for College Students (BASICS) program following a campus alcohol violation would benefit as much as heavy drinking volunteers up to one year post-intervention using control groups with high-risk drinkers to model disciplinary-related and naturalistic changes in drinking. Participants (61% male; 51% mandated; 84% Caucasian; Mage = 20.14 years) were screened for heavy drinking and randomized to BASICS (n = 115) or assessment-only control (n = 110). Outcome measures (drinking, alcohol problems) were collected at baseline, 4 weeks, 3, 6, and 12 months post-intervention. At 4 weeks post-intervention, intent-to-treat multilevel longitudinal models showed that regardless of referral group (mandated or volunteer) BASICS significantly decreased weekly drinking, typical drinks, and peak drinks relative to controls (ds = .41-.92). BASICS had a large effect on decreases in alcohol problems (d = .87). At 12 months post-intervention, BASICS participants (regardless of referral group) reported significantly fewer alcohol problems (d = .56) compared to controls. Significant long-term intervention gains for peak and typical drinks were sustained in both referral groups relative to controls (ds = .42; .11). Referral group had no significant main effect and did not interact with intervention condition to predict outcomes. Given that BASICS was associated with less drinking and fewer alcohol problems (even among heavier drinking mandated students up to one year post-intervention), provision of BASICS-style programs within disciplinary settings may help reduce heavy and problematic drinking among at-risk students. PMID:25844834

  1. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial

    PubMed Central

    Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

    2010-01-01

    Objective To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Methods Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. Results For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p<0.001) and culture results (4 vs 8 days, p<0.001) and had a lower proportion of ‘late’ DSTs taking >60 days to arrive (p<0.001) than the control. For peripheral HCs, the intervention group had similar communication times for DST (median 22 vs 19 days, p=0.30) and culture (10 vs 9 days, p=0.10) results, as well as proportion of ‘late’ DSTs (p=0.57) compared with the control. Conclusions Only point-of-care HCs with direct access to the e-Chasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting. PMID:21113076

  2. Effects of Voice Rehabilitation After Radiation Therapy for Laryngeal Cancer: A Randomized Controlled Study

    SciTech Connect

    Tuomi, Lisa; Andréll, Paulin

    2014-08-01

    Background: Patients treated with radiation therapy for laryngeal cancer often experience voice problems. The aim of this randomized controlled trial was to assess the efficacy of voice rehabilitation for laryngeal cancer patients after having undergone radiation therapy and to investigate whether differences between different tumor localizations with regard to rehabilitation outcomes exist. Methods and Materials: Sixty-nine male patients irradiated for laryngeal cancer participated. Voice recordings and self-assessments of communicative dysfunction were performed 1 and 6 months after radiation therapy. Thirty-three patients were randomized to structured voice rehabilitation with a speech-language pathologist and 36 to a control group. Furthermore, comparisons with 23 healthy control individuals were made. Acoustic analyses were performed for all patients, including the healthy control individuals. The Swedish version of the Self Evaluation of Communication Experiences after Laryngeal Cancer and self-ratings of voice function were used to assess vocal and communicative function. Results: The patients who received vocal rehabilitation experienced improved self-rated vocal function after rehabilitation. Patients with supraglottic tumors who received voice rehabilitation had statistically significant improvements in voice quality and self-rated vocal function, whereas the control group did not. Conclusion: Voice rehabilitation for male patients with laryngeal cancer is efficacious regarding patient-reported outcome measurements. The patients experienced better voice function after rehabilitation. Patients with supraglottic tumors also showed an improvement in terms of acoustic voice outcomes. Rehabilitation with a speech-language pathologist is recommended for laryngeal cancer patients after radiation therapy, particularly for patients with supraglottic tumors.

  3. Cognitive Behaviour Therapy for Anxiety and Depression among People Undergoing Haemodialysis: A Randomized Control Trial

    PubMed Central

    Bhat, Shripathy M.; Latha, K.S.

    2016-01-01

    Introduction Chronic Kidney Disease (CKD) is becoming a major public health problem worldwide. The very diagnosis of CKD brings a plethora of psychological problems that adds to the agony of the debilitating illness. Financial difficulties apart from the excruciating physical burden of the disease, owing to series of psychosocial issues. Anxiety and depression are two major concerns that to be managed effectively to sustain the life of people undergoing Haemodialysis. Aim The study aimed at finding the effect of Cognitive Behaviour Therapy (CBT) on anxiety and depression among people undergoing haemodialysis. Materials and Methods An experimental approach with Randomized controlled trial design was adopted for the study. The instruments used for data collection were Background Proforma and Hospital Anxiety and Depression Scale (HADS). A total of 150 subjects undergoing haemodialysis in a tertiary care hospital of South Karnataka were screened for inclusion and exclusion criteria and 80 participants were recruited for the study. Through computerized block randomization 40 each were allotted to experimental and control groups whereas 33 and 34 respectively in both the groups completed the study. CBT, a structured individual therapy of cognitive, behavioural and didactic techniques, with 10 weekly sessions each was administered to the experimental group. Non-directed counseling, a psychological intervention with ten weekly sessions of individual counseling was given to the control group. Results The findings of the study revealed that there was a significant reduction of mean anxiety (F=76.739, p=0.001) and depression (F=57.326, p= 0.001) in the experimental group when compared with the control group. Conclusion Researchers concluded that CBT can be effectively utilized for people undergoing haemodialysis in order to obtain control over their negative thoughts thereby reducing anxiety and depression. PMID:27656536

  4. Preparing individuals to communicate genetic test results to their relatives: report of a randomized control trial.

    PubMed

    Montgomery, Susan V; Barsevick, Andrea M; Egleston, Brian L; Bingler, Ruth; Ruth, Karen; Miller, Suzanne M; Malick, John; Cescon, Terrence P; Daly, Mary B

    2013-09-01

    This study reports a randomized clinical trial evaluating the efficacy of an intervention to prepare individuals to communicate BRCA1/BRCA2 results to family members. Women aged 18 years and older, who had genetic testing, and who had adult first-degree relatives, were randomly assigned to a communication skills-building intervention or a wellness control session. Primary outcomes were the percentage of probands sharing test results, and the level of distress associated with sharing. The ability of the theory of planned behavior variables to predict the outcomes was explored. Four hundred twenty-two women were enrolled in the study, 219 (intervention) and 203 (control). Data from 137 in the intervention group and 112 in the control group were analyzed. Two hundred forty-nine probands shared test results with 838 relatives (80.1 %). There were no significant differences between study groups in the primary outcomes. Combining data from both arms revealed that perceived control and specific social influence were associated with sharing. Probands were more likely to share genetic test results with their children, female relatives and relatives who they perceived had a favorable opinion about learning the results. The communication skills intervention did not impact sharing of test results. The proband's perception of her relative's opinion of genetic testing and her sense of control in relaying this information influenced sharing. Communication of test results is selective, with male relatives and parents less likely to be informed. Prevalent psychosocial factors play a role in the communication of genetic test results within families.

  5. Supportive Nursing Care and Satisfaction of Patients Receiving Electroconvulsive Therapy: A Randomized Controlled Clinical Trial

    PubMed Central

    Navidian, Ali; Ebrahimi, Hossein; Keykha, Roghaieh

    2015-01-01

    Background: Patient satisfaction is the most important criterion in evaluating the quality of care. Besides, its assessment in patients with severe mental disorder treated by electroconvulsive therapy (ECT) is highly appropriate. The ECT is accompanied by lower satisfaction and may exacerbate the patients’ condition. Objectives: The current study aimed to determine the effect of supportive nursing care on the satisfaction of patients receiving ECT. Patients and Methods: This randomized controlled trial was conducted in the education center of Baharan psychiatric hospital, Zahedan, Iran. Seventy hospitalized patients receiving ECT were randomly divided into two groups of control (n = 35) and intervention (n = 35).The socio-personal and Webster Satisfaction Questionnaire were used as data collection tools. The intervention group received supportive nursing care by nurses trained in informational, emotional, and physical aspects. The control group received only regular nursing care. The levels of satisfaction were measured and compared between groups, before and after the intervention. Data were analyzed using the SPSS software, and Chi-square, independent and paired t tests, as well as covariance analysis were performed. Results: The results showed similarities in socio-personal characteristics of both groups. However, there was a significant difference (P < 0.001) between the means of satisfaction in the groups, predominantly for the intervention group. In other words, a significant difference (P < 0.001) was observed between the means of satisfaction of the intervention (54.71 ± 5.27) and control (36.28 ± 7.00) groups after intervention by controlling the effect of socio-personal variables. Conclusions: Results of the current study confirmed the effect of supportive nursing care on increasing the level of satisfaction in ECT receiving patients, recommending the use of this therapeutic method. PMID:26473077

  6. Occupation and small bowel adenocarcinoma: a European case-control study

    PubMed Central

    Kaerlev, L.; Teglbjaerg, P. S.; Sabroe, S.; Kolstad, H.; Ahrens, W.; Eriksson, M.; Gonzalez, A. L.; Guenel, P.; Hardell, L.; Launoy, G.; Merler, E.; Merletti, F.; Suarez-Varela, M.; Stang, A.

    2000-01-01

    OBJECTIVES—Because of the rarity of small bowel adenocarcinoma (SBA), little is known about the aetiology of this disease. This study aimed to identify occupational clustering of cases SBA as a systematic approach to new hypotheses on the aetiology of this disease.
METHODS—A European multicentre case-control study was conducted in 1995-7, inclusive. Incident cases aged 35-69 years with SBA (n=168) were recruited before acceptance by a pathologist. Altogether 107 cases and 3915 controls were accepted, of which 79 cases, 579 colon cancer controls, and 2070 population controls were interviewed.
RESULTS—The strongest industrial risk factors for SBA taking account of 10 years' exposure lag were dry cleaning, manufacture of workwear, mixed farming (women), and manufacture of motor vehicles (men). A significantly increased risk of SBA (odds ratio (OR) and 95% confidence interval (95% CI)) was found among men employed as building caretakers, OR 6.7 (1.7 to 26.0) and women employed as housekeepers, OR 2.2 (1.1 to 4.9); general farm labourers, OR 4.7 (1.8 to 12.2); dockers, OR 2.9 (1.0 to 8.2); dry cleaners or launderers, OR 4.1 (1.2 to 13.6); and textile workers (sewers or embroiders), OR 2.6 (1.0 to 6.8). For the last four groups, together with welders OR 2.7 (1.1 to 6.6) (men) an exposure-response pattern was found when calculating the ORs for jobs held 1-5 years and >5 years, with never having held the job as reference. The ORs (95% CIs) for 1-5 years and >5 years were 4.3 (0.4 to 44.0) and 3.5 (0.9 to 13.7), 3.0 (0.3 to 26.2) and 4.3 (0.9 to 21.2), 4.6 (0.4 to 48.1) and 11.0 (2.0 to 60.4), 1.3 (0.2 to 11.0) and 5.8 (2.0 to 17.2), and 2.8 (0.3 to 23.8) and 4.6 (1.3 to 16.6), respectively, for each of these occupations. Among welders, people performing semiautomatic arc welding (MIG/MAG) were identified as a high risk group (OR 5.0 (1.3 to 19.6)). 
CONCLUSIONS—This explorative study suggests an increased occurrence

  7. Control logic to track the outputs of a command generator or randomly forced target

    NASA Technical Reports Server (NTRS)

    Trankle, T. L.; Bryson, A. E., Jr.

    1977-01-01

    A procedure is presented for synthesizing time-invariant control logic to cause the outputs of a linear plant to track the outputs of an unforced (or randomly forced) linear dynamic system. The control logic uses feed-forward of the reference system state variables and feedback of the plant state variables. The feed-forward gains are obtained from the solution of a linear algebraic matrix equation of the Liapunov type. The feedback gains are the usual regulator gains, determined to stabilize (or augment the stability of) the plant, possibly including integral control. The method is applied here to the design of control logic for a second-order servomechanism to follow a linearly increasing (ramp) signal, an unstable third-order system with two controls to track two separate ramp signals, and a sixth-order system with two controls to track a constant signal and an exponentially decreasing signal (aircraft landing-flare or glide-slope-capture with constant velocity).

  8. Effectiveness of a Novel Integrative Online Treatment for Depression (Deprexis): Randomized Controlled Trial

    PubMed Central

    Berger, Thomas; Caspar, Franz; Beevers, Christopher G; Andersson, Gerhard; Weiss, Mario

    2009-01-01

    Background Depression is associated with immense suffering and costs, and many patients receive inadequate care, often because of the limited availability of treatment. Web-based treatments may play an increasingly important role in closing this gap between demand and supply. We developed the integrative, Web-based program Deprexis, which covers therapeutic approaches such as behavioral activation, cognitive restructuring, mindfulness/acceptance exercises, and social skills training. Objective To evaluate the effectiveness of the Web-based intervention in a randomized controlled trial. Methods There were 396 adults recruited via Internet depression forums in Germany, and they were randomly assigned in an 80:20 weighted randomization sequence to either 9 weeks of immediate-program-access as an add-on to treatment-as-usual (N = 320), or to a 9-week delayed-access plus treatment-as-usual condition (N = 76). At pre- and post-treatment and 6-month follow-up, we measured depression (Beck Depression Inventory) as the primary outcome measure and social functioning (Work and Social Adjustment Scale) as the secondary outcome measure. Completer analyses and intention-to-treat analyses were performed. Results Of 396 participants, 216 (55%) completed the post-measurement 9 weeks later. Available case analyses revealed a significant reduction in depression severity (BDI), Cohen’s d = .64 (CI 95% = 0.33 - 0.94), and significant improvement in social functioning (WSA), Cohen’s d = .64, 95% (CI 95% = 0.33 - 0.95). These improvements were maintained at 6-month follow-up. Intention-to-treat analyses confirmed significant effects on depression and social functioning improvements (BDI: Cohen’s d = .30, CI 95% = 0.05 - 0.55; WSA: Cohen’s d = .36, CI 95% = 0.10 - 0.61). Moreover, a much higher percentage of patients in the intervention group experienced a significant reduction of depression symptoms (BDI: odds ratio [OR] = 6.8, CI 95% = 2.90 - 18.19) and recovered more often (OR

  9. A Randomized Controlled Study to Compare Conventional and Evidence Based Treatment Protocols in Fresh Compound Fractures

    PubMed Central

    Mahajan, Kanika; Singh, Girish Kumar; Kumar, Santosh; Avasthi, Sachin

    2016-01-01

    Introduction A recent concept review in Journal of Bone and Joint Surgery (JBJS) outlines evidence to control peri-operative infections in compound fractures. However, evidence for impact of adopting a protocol combining measures that have some evidence is lacking in literature. The present method of treatment at King George’s Medical University (KGMU) is representative of the conventional practice of managing compound fractures in India and is an appropriate control for trial against the Experimental Evidence Based Protocol (EBP). Aim To study the additional impact of adopting Evidence Based Protocol on parameters defining infection rate and bone union. Materials and Methods This randomized controlled study was conducted at the orthopaedics department of KGMU. Two hundred and twenty six patients of compound fractures of both bone leg, age > 12y were randomized to two groups. One group received standard treatment and the experimental group received treatment as per JBJS review. Statistical Analysis Random allocation was tested by comparing baseline characteristics of the two groups. The two groups were compared for all the outcome variables in terms of time to a negative wound culture, time to wound healing, time to union at fracture site and time to achieve complete range of motion at knee joint. Results Random allocation was successful. EBP group reported significantly lesser time to a negative culture report from wound (mean in conventional=4.619, experimental=1.9146, p=0.0006), lesser time to bony union (mean in conventional=23.8427 weeks, experimental=22.8125 weeks, p=0.0027), lesser time to wound healing (mean in conventional=14.4425 weeks experimental=10.4513 weeks, p=0.0032), and a lesser duration of hospital stay (mean in conventional=6.5982 days, experimental=4.5000 days, p=0.0343). Conclusion EBP based on the guidelines suggested by Fletcher et al., significantly shorten the time taken for achieving a negative culture and hasten wound and fracture

  10. Supported Telemonitoring and Glycemic Control in People with Type 2 Diabetes: The Telescot Diabetes Pragmatic Multicenter Randomized Controlled Trial

    PubMed Central

    Wild, Sarah H.; Hanley, Janet; Lewis, Stephanie C.; McKnight, John A.; Padfield, Paul L.; Parker, Richard A.; Pinnock, Hilary; Sheikh, Aziz; McKinstry, Brian

    2016-01-01

    Background Self-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes. Methods and Findings We performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56–5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62–3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant

  11. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    PubMed

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits.

  12. Traumatic Brain Injury in Latin America: Lifespan Analysis Randomized Control Trial Protocol

    PubMed Central

    Chesnut, Randall M.; Temkin, Nancy; Carney, Nancy; Dikmen, Sureyya; Pridgeon, Jim; Barber, Jason; Celix, Juanita M.; Chaddock, Kelley; Cherner, Marianna; Hendrix, Terence; Lujan, Silvia; Machamer, Joan; Petroni, Gustavo; Rondina, Carlos; Videtta, Walter

    2012-01-01

    Background Although in the developed world the intracranial pressure (ICP) monitor is considered “standard of care” for patients with severe traumatic brain injury (TBI), its usefulness to direct treatment decisions has never been tested rigorously. Objective The primary focus is to conduct a high quality randomized, controlled trial to determine if ICP monitoring used to direct TBI treatment improves patient outcomes. By providing education, equipment, and structure, the project will enhance the research capacity of the collaborating investigators and will foster the collaborations established during earlier studies (add refs to papers from earlier studies). Methods Study centers were selected that routinely treated ICP based on clinical examination and CT imaging using internal protocols. We randomize patients to either an ICP Monitor Group or an Imaging and Clinical Examination Group. Treatment decisions for the ICP Monitor Group are guided by ICP monitoring, based on established guidelines. Treatment decisions for the Imaging and Clinical Examination Group are made using a single protocol derived from those previously being used at those centers. Expected Outcomes There are two study hypotheses: 1) Patients with severe TBI whose acute care treatment is managed using ICP monitors will have improved outcomes and 2) incorporating ICP monitoring into the care of patients with severe TBI will minimize complications and decrease length of ICU stay. Discussion This clinical trial tests the effectiveness of a management protocol based on technology considered pivotal to brain trauma treatment in the developed world - the ICP monitor. A randomized controlled trial of ICP monitoring has never been performed - a critical gap in the evidence base that supports the role of ICP monitoring in TBI care. As such, the results of this RCT will have global implications regardless of the level of development of the trauma system. PMID:22986600

  13. Safety data from randomized controlled trials: applying models for recurrent events.

    PubMed

    Hengelbrock, Johannes; Gillhaus, Johanna; Kloss, Sebastian; Leverkus, Friedhelm

    2016-07-01

    Simple descriptive listings and inference statistics based on 2×2 tables are still the most common way of summarizing and reporting adverse events data from randomized controlled trials, although these methods do not account for differences in observation times between treatment groups. Using standard methods from survival analysis such as the Cox model or Kaplan-Meier estimates would overcome this problem but limit the analysis to the first safety-related event of each subject. As an alternative, we discuss two models for recurrent events data-the Andersen-Gill and Prentice-Williams-Peterson model-regarding their applicability to safety data from randomized controlled trials. We argue that these models can be used to estimate two different quantities: a direct treatment effect on the risk of an event (Prentice-Williams-Peterson) and a total treatment effect as sum of the direct effect and the treatment's indirect effect via the event history (Anderson-Gill). Using simulated data, we illustrate the difference between these treatment effects and analyze the performance of both models in different scenarios. Because both models are limited to the analysis of cause-specific hazards if competing risks are present, we suggest to incorporate estimates of the mean frequency of events in the analysis to additionally allow the comparison of treatment effects on absolute event probabilities. We demonstrate the application of both models and the mean frequency function to safety endpoints with an illustrative analysis of data from a randomized phase-III study. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27291933

  14. A randomized placebo-controlled trial of Ginkgo biloba for the prevention of cognitive decline

    PubMed Central

    Zitzelberger, T.; Oken, B.S.; Howieson, D.; Kaye, J.

    2009-01-01

    Objective To assess the feasibility, safety, and efficacy of Ginkgo biloba extract (GBE) on delaying the progression to cognitive impairment in normal elderly aged 85 and older. Methods Randomized, placebo-controlled, double-blind, 42-month pilot study with 118 cognitively intact subjects randomized to standardized GBE or placebo. Kaplan-Meier estimation, Cox proportional hazard, and random-effects models were used to compare the risk of progression from Clinical Dementia Rating (CDR) = 0 to CDR = 0.5 and decline in episodic memory function between GBE and placebo groups. Results In the intention-to-treat analysis, there was no reduced risk of progression to CDR = 0.5 (log-rank test, p = 0.06) among the GBE group. There was no less of a decline in memory function among the GBE group (p = 0.05). In the secondary analysis, where we controlled the medication adherence level, the GBE group had a lower risk of progression from CDR = 0 to CDR = 0.5 (HR = 0.33, p = 0.02), and a smaller decline in memory scores (p = 0.04). There were more ischemic strokes and TIAs in the GBE group (p = 0.01). Conclusions In unadjusted analyses, Ginkgo biloba extract (GBE) neither altered the risk of progression from normal to Clinical Dementia Rating (CDR) = 0.5, nor protected against a decline in memory function. Secondary analysis taking into account medication adherence showed a protective effect of GBE on the progression to CDR = 0.5 and memory decline. Results of larger prevention trials taking into account medication adherence may clarify the effectiveness of GBE. More stroke and TIA cases observed among the GBE group requires further study to confirm. PMID:18305231

  15. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol

    PubMed Central

    Lester, Richard T; Mills, Edward J; Kariri, Antony; Ritvo, Paul; Chung, Michael; Jack, William; Habyarimana, James; Karanja, Sarah; Barasa, Samson; Nguti, Rosemary; Estambale, Benson; Ngugi, Elizabeth; Ball, T Blake; Thabane, Lehana; Kimani, Joshua; Gelmon, Lawrence; Ackers, Marta; Plummer, Francis A

    2009-01-01

    Background The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya. Methods and Design A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to receive either a structured weekly SMS ('short message system' or text message) slogan (the intervention) or current standard of care support mechanisms alone (the control). Our hypothesis is that using a structured mobile phone protocol to keep in touch with patients will improve adherence to ART and other patient outcomes. Participants are evaluated at baseline, and then at six and twelve months after initiating ART. The care providers keep a weekly study log of all phone based communications with study participants. Primary outcomes are self-reported adherence to ART and suppression of HIV viral load at twelve months scheduled follow-up. Secondary outcomes are improvements in health, quality of life, social and economic factors, and retention on ART. Primary analysis is by 'intention-to-treat'. Sensitivity analysis will be used to assess per-protocol effects. Analysis of covariates will be undertaken to determine factors that contribute or deter from expected and determined outcomes. Discussion This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting. Trial Registration Trial Registration Number: NCT00830622 PMID:19772596

  16. Mental practice with motor imagery in stroke recovery: randomized controlled trial of efficacy

    PubMed Central

    Johnston, Marie; Dijkerman, H. Chris; Joice, Sara; Scott, Clare L.; MacWalter, Ronald S.; Hamilton, Steven J.C.

    2011-01-01

    This randomized controlled trial evaluated the therapeutic benefit of mental practice with motor imagery in stroke patients with persistent upper limb motor weakness. There is evidence to suggest that mental rehearsal of movement can produce effects normally attributed to practising the actual movements. Imagining hand movements could stimulate restitution and redistribution of brain activity, which accompanies recovery of hand function, thus resulting in a reduced motor deficit. Current efficacy evidence for mental practice with motor imagery in stroke is insufficient due to methodological limitations. This randomized controlled sequential cohort study included 121 stroke patients with a residual upper limb weakness within 6 months following stroke (on average <3 months post-stroke). Randomization was performed using an automated statistical minimizing procedure. The primary outcome measure was a blinded rating on the Action Research Arm test. The study analysed the outcome of 39 patients involved in 4 weeks of mental rehearsal of upper limb movements during 45-min supervised sessions three times a week and structured independent sessions twice a week, compared to 31 patients who performed equally intensive non-motor mental rehearsal, and 32 patients receiving normal care without additional training. No differences between the treatment groups were found at baseline or outcome on the Action Research Arm Test (ANCOVA statistical P = 0.77, and effect size partial η2 = 0.005) or any of the secondary outcome measures. Results suggest that mental practice with motor imagery does not enhance motor recovery in patients early post-stroke. In light of the evidence, it remains to be seen whether mental practice with motor imagery is a valid rehabilitation technique in its own right. PMID:21515905

  17. A Behavioral Intervention for War-Affected Youth in Sierra Leone: A Randomized Controlled Trial

    PubMed Central

    Betancourt, Theresa S.; McBain, Ryan; Newnham, Elizabeth A.; Akinsulure-Smith, Adeyinka M.; Brennan, Robert T.; Weisz, John R.; Hansen, Nathan B.

    2016-01-01

    Objective Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)–based group mental health intervention for multisymptomatic war-affected youth (aged 15–24 years) in Sierra Leone. Method War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. Results The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. Conclusion YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI

  18. Massage Therapy for Fibromyalgia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Li, Yan-hui; Wang, Feng-yun; Feng, Chun-qing; Yang, Xia-feng; Sun, Yi-hua

    2014-01-01

    Background Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM), the role of massage therapy in the management of FM remained controversial. Objective The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. Methods Electronic databases (up to June 2013) were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD) and 95% confidence intervals (CI) were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I2 statistic. Results Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03), anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01), and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005) in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI −0.38 to 0.75; p = 0.52). Conclusion Massage therapy with duration ≥5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings. PMID:24586677

  19. Randomized controlled trial of the Medifast 5 & 1 Plan for weight loss

    PubMed Central

    Shikany, James M.; Thomas, Amy S.; Beasley, T. Mark; Lewis, Cora E.; Allison, David B.

    2013-01-01

    Objective The Medifast 5 & 1 Plan (MD) is a portion-controlled, nutritionally-balanced, low-fat weight-loss plan. We studied the effects of MD compared with a reduced-energy, food-based diet (FB) on body weight, waist circumference, fat mass, and other measures in adults. Design We conducted a 2 parallel-arm, randomized, controlled trial comparing MD to FB over 52 weeks. A total of 120 men and women aged 19-65 years with BMI ≥35 and ≤50 kg/m2 were randomized to MD (n = 60) or FB (n = 60). Follow-up included a 26-week weight-loss phase and 26-week weight-maintenance phase. Anthropometric, body composition, biochemical, and appetite/satiety measures were performed at baseline, 26 and 52 weeks. An intention-to-treat, linear mixed models analysis was the primary analysis. Results Fifty MD subjects (83.3%) and 45 FB subjects (75.0%) completed the study on assigned treatment. At 26 weeks, race-adjusted mean weight loss was 7.5 kg in MD subjects vs. 3.8 kg in FB subjects (P = 0.0002 for difference); reduction in waist circumference was 5.7 cm in MD vs. 3.7 cm in FB (P = 0.0064); and fat mass loss was 6.4 kg in MD vs. 3.7 kg in FB (P = 0.0011). At 52 weeks, the corresponding reductions were 4.7 vs. 1.9 kg (P = 0.0004); 5.0 vs. 3.6 cm (P = 0.0082); and 4.1 vs. 1.9 kg (P = 0.0019) in MD and FB subjects, respectively. Conclusion In obese adults, MD resulted in significantly greater reductions in body weight and fat compared with an FB diet for one year after randomization. PMID:23567927

  20. Implementing Randomized Controlled Trials in Preschool Settings That Include Young Children with Disabilities: Considering the Context of Strain and Bovey

    ERIC Educational Resources Information Center

    Snyder, Patricia

    2011-01-01

    In this commentary, developments related to conducting randomized controlled trials in authentic preschool settings that include young children with disabilities are discussed in relation to the Strain and Bovey study.

  1. Effect of Chromium Supplementation on Glucose Metabolism and Lipids: A Systematic Review with Meta-Analysis of Randomized Controlled Trials

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Objective. A systematic review of the effect of chromium supplementation on glucose metabolism and lipid levels. Research Design and Methods. Literature search conducted in MEDLINE and Commonwealth Agricultural Bureau. Eligible studies were English language randomized controlled trials of chromium ...

  2. Adaptive control of the propagation of ultrafast light through random and nonlinear media

    NASA Astrophysics Data System (ADS)

    Moores, Mark David

    2001-12-01

    Ultrafast light sources generate coherent pulses with durations of less than one picosecond, and represent the next generation of illuminators for medical imaging and optical communications applications. Such sources are already widely used experimentally. Correction of temporal widths or pulse envelopes after traversal of optically non-ideal materials is critical for the delivery of optimal ultrashort pulses. It is important to investigate the physical mechanisms that distort pulses and to develop and implement methods for minimizing these effects. In this work, we investigate methods for characterizing and manipulating pulse propagation dynamics in random (scattering) and nonlinear optical media. In particular, we use pulse shaping to manipulate the light field of ultrashort infrared pulses. Application of spectral phase by a liquid crystal spatial light modulator is used to control the temporal pulse shape. The applied phase is controlled by a genetic algorithm that adaptively responds to the feedback from previous phase profiles. Experiments are detailed that address related aspects of the character of ultrafast pulses-the short timescales and necessarily wide frequency bandwidths. Material dispersion is by definition frequency dependent. Passage through an inhomogeneous system of randomly situated boundaries (scatterers) causes additional distortion of ballistic pulses due to multiple reflections. The reflected rays accumulate phase shifts that depend on the separation of the reflecting boundaries and the photon frequency. Ultrafast bandwidths present a wide range of frequencies for dispersion and interaction with macroscopic dielectric structure. The shaper and adaptive learning algorithm are used to reduce these effects, lessening the impact of the scattering medium on propagating pulses. The timescale of ultrashort pulses results in peak intensities that interact with the electronic structure of optical materials to induce polarization that is no longer

  3. Just-in-Time Information Improved Decision-Making in Primary Care: A Randomized Controlled Trial

    PubMed Central

    McGowan, Jessie; Hogg, William; Campbell, Craig; Rowan, Margo

    2008-01-01

    Background The “Just-in-time Information” (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. Methods and Finding A randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued. Conclusions In this study, providing timely information to clinical questions had a highly positive impact on decision

  4. Topical Tacrolimus versus Hydrocortisone on Atopic Dermatitis in Paediatric Patients: A Randomized Controlled Trial.

    PubMed

    Rahman, M F; Nandi, A K; Kabir, S; Kamal, M; Basher, M S; Banu, L A

    2015-07-01

    Atopic dermatitis (AD) is a chronic, inflammatory skin disease in early childhood. Atopic dermatitis is familial disease, often coexists with other atopic diseases with multiple risk factors associated with atopic eczema. The disease is more frequent in urban areas compared with rural areas. Changes in nutrition and a decrease in infant breast-feeding and respiratory allergies are contributory factors for the condition. A Randomized Controlled Trial (RCT) was carried to compare the efficacy and safety of Tacrolimus ointment with a topical corticosteroid reference therapy. A total 60 patients aged between 2 to 10 years, having atopic dermatitis for at least one year and comply Hanifin-Rajka criteria were selected using random number table and allocated into study and control groups through randomization. Study group was treated with topical Tacrolimus 0.03% twice daily for three weeks, while the control group was treated with 1% Hydrocortisone acetate for the same period. Both groups had a washed out phase for 2 weeks with a follow up period of 6 weeks. Eczema Area and Severity lndex (EASI) was assessed at baseline and three weeks after treatment. Efficacy was evaluated at each visit by six clinical signs of atopic dermatitis through measurement of the affected surface area and the EASI score in each of four body regions. Before intervention, in study group mean EASI score was 11.29 with a SD of 2.14, while in control group it was 11.05 with a SD of 2.46. Difference was statistically insignificant (p>0.05). At the end of the treatment, in study group mean EASI score was 4.86 with a SD of 1.01, while in control group it was 7.97 with a SD of 1.80. Statistically high significant difference was observed between EASI scores of two groups before and after the treatment (p<0.001). After getting treatment with Tacrolimus, median reduction of EASI score was 56.07 in study group, while getting treatment with Hydrocortisone, median reduction of EASI score was 27

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

    PubMed Central

    2012-01-01

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

  6. Generation of a human control iPSC line with a European mitochondrial haplogroup U background.

    PubMed

    Galera, Teresa; Zurita, Francisco; González-Páramos, Cristina; Moreno-Izquierdo, Ana; Fraga, Mario F; Fernández, Agustin F; Garesse, Rafael; Gallardo, M Esther

    2016-01-01

    Human iPSC line N44SV.5 was generated from primary normal human dermal fibroblasts belonging to the European mitochondrial haplogroup U. For this purpose, reprogramming factors Oct3/4, Sox2, Klf4, and cMyc were delivered using a non-integrative methodology that involves the use of Sendai virus. PMID:27345790

  7. Probiotic supplementation can positively affect anxiety and depressive symptoms: a systematic review of randomized controlled trials.

    PubMed

    Pirbaglou, Meysam; Katz, Joel; de Souza, Russell J; Stearns, Jennifer C; Motamed, Mehras; Ritvo, Paul

    2016-09-01

    Gastrointestinal microbiota, consisting of microbial communities in the gastrointestinal tract, play an important role in digestive, metabolic, and immune functioning. Preclinical studies on rodents have linked behavioral and neurochemical changes in the central nervous system with deficits or alterations in these bacterial communities. Moreover, probiotic supplementation in rodents has been shown to markedly change behavior, with correlated changes in central neurochemistry. While such studies have documented behavioral and mood-related supplementation effects, the significance of these effects in humans, especially in relation to anxiety and depression symptoms, are relatively unknown. Thus, the purpose of this paper was to systematically evaluate current literature on the impact of probiotic supplementation on anxiety and depression symptoms in humans. To this end, multiple databases, including Medline, PsycINFO, PubMed, Scopus, and Web of Science were searched for randomized controlled trials published between January 1990 and January 2016. Search results led to a total of 10 randomized controlled trials (4 in clinically diagnosed and 6 in non-clinical samples) that provided limited support for the use of some probiotics in reducing human anxiety and depression. Despite methodological limitations of the included trials and the complex nature of gut-brain interactions, results suggest the detection of apparent psychological benefits from probiotic supplementation. Nevertheless a better understanding of developmental, modulatory, and metagenomic influences on the GI microbiota, specifically as they relate to mood and mental health, represent strong priorities for future research in this area. PMID:27632908

  8. Primary prevention of skin dysplasia in renal transplant recipients with photodynamic therapy: a randomized controlled trial.

    PubMed

    Togsverd-Bo, K; Omland, S H; Wulf, H C; Sørensen, S S; Haedersdal, M

    2015-11-01

    Organ transplant recipients (OTRs) are at high risk of developing cutaneous squamous cell carcinoma (SCC); prevention includes early treatment of premalignant actinic keratosis (AK). Photodynamic therapy (PDT) is a noninvasive field therapy that reduces new AKs in patients with existing AK and delays SCC development in mice. We investigated the effect of repeated PDT over 5 years for primary prophylaxis of skin dysplasia. These data represent an interim analysis of an on-going randomized controlled trial. During 2008-2011, 25 renal transplant recipients with clinically normal skin were randomized to split-side PDT of the face, forearm and hand, the contralateral side serving as untreated control. Patients received PDT on inclusion and at 6-monthly intervals for 5 years. Blinded evaluation was performed at each visit. We found that prophylactic PDT significantly delayed onset of AK compared with untreated skin, p = 0.020. At 3-year follow-up, we observed AK in 63% of patients in untreated skin areas compared with 28% of patients in PDT-treated skin, with a total number of cumulated AKs in untreated skin (n = 43) compared with PDT-treated skin (n = 8), p = 0.005. These preliminary data indicate a novel approach to early prevention of skin dysplasia that may reduce morbidity from multiple AKs and SCCs in OTR. PMID:26018207

  9. Does Encouragement Matter in Improving Gender Imbalances in Technical Fields? Evidence from a Randomized Controlled Trial.

    PubMed

    Unkovic, Cait; Sen, Maya; Quinn, Kevin M

    2016-01-01

    Does encouragement help address gender imbalances in technical fields? We present the results of one of the first and largest randomized controlled trials on the topic. Using an applied statistics conference in the social sciences as our context, we randomly assigned half of a pool of 3,945 graduate students to receive two personalized emails encouraging them to apply (n = 1,976) and the other half to receive nothing (n = 1,969). We find a robust, positive effect associated with this simple intervention and suggestive evidence that women responded more strongly than men. However, we find that women's conference acceptance rates are higher within the control group than in the treated group. This is not the case for men. The reason appears to be that female applicants in the treated group solicited supporting letters at lower rates. Our findings therefore suggest that "low dose" interventions may promote diversity in STEM fields but may also have the potential to expose underlying disparities when used alone or in a non-targeted way.

  10. A Randomized, Controlled Trial of Immersive Virtual Reality Analgesia during Physical Therapy for Pediatric Burn Injuries

    PubMed Central

    Schmitt, Yuko S.; Hoffman, Hunter G.; Blough, David K.; Patterson, David R.; Jensen, Mark P.; Soltani, Maryam; Carrougher, Gretchen J.; Nakamura, Dana; Sharar, Sam R.

    2010-01-01

    This randomized, controlled, within-subjects (crossover design) study examined the effects of immersive virtual reality as an adjunctive analgesic technique for hospitalized pediatric burn inpatients undergoing painful physical therapy. Fifty-four subjects (6–19 years old) performed range-of-motion exercises under a therapist’s direction for one to five days. During each session, subjects spent equivalent time in both the virtual reality and the control conditions (treatment order randomized and counterbalanced). Graphic rating scale scores assessing the sensory, affective, and cognitive components of pain were obtained for each treatment condition. Secondary outcomes assessed subjects’ perception of the virtual reality experience and maximum range-of-motion. Results showed that on study day one, subjects reported significant decreases (27–44%) in pain ratings during virtual reality. They also reported improved affect (“fun”) during virtual reality. The analgesia and affect improvements were maintained with repeated virtual reality use over multiple therapy sessions. Maximum range-of-motion was not different between treatment conditions, but was significantly greater after the second treatment condition (regardless of treatment order). These results suggest that immersive virtual reality is an effective nonpharmacologic, adjunctive pain reduction technique in the pediatric burn population undergoing painful rehabilitation therapy. The magnitude of the analgesic effect is clinically meaningful and is maintained with repeated use. PMID:20692769

  11. Acupoints Stimulation for Anxiety and Depression in Cancer Patients: A Quantitative Synthesis of Randomized Controlled Trials

    PubMed Central

    Wang, Tao; Deng, Renli; Tan, Jing-Yu; Guan, Feng-Guang

    2016-01-01

    This study aims at concluding the current evidence on the therapeutic effects of acupoints stimulation for cancer patients with anxiety and depression. Randomized controlled trials using acupoints stimulation for relieving anxiety and/or depression in cancer patients were searched, and 11 studies were finally included, of which eight trials compared acupoints stimulation with standard methods of treatment/care, and acupoints stimulation showed significantly better effects in improving depression than using standard methods of treatment/care. Four studies compared true acupoints stimulation with sham methods, and no significant differences can be found between groups for either depression or anxiety, although the pooled effects still favored true intervention. For the five studies that evaluated sleep quality, the results were conflicting, with three supporting the superiority of acupoints stimulation in improving sleep quality and two demonstrating no differences across groups. Acupoints stimulation seems to be an effective approach in relieving depression and anxiety in cancer patients, and placebo effects may partially contribute to the benefits. However, the evidence is not conclusive due to the limited number of included studies and the clinical heterogeneity identified among trials. More rigorous designed randomized, sham-controlled studies are necessary in future research. PMID:27118981

  12. Shape-controlled percolation transition in 2D random packing of asymmetric dimers

    NASA Astrophysics Data System (ADS)

    Han, Youngkyu; Lee, Juncheol; Choi, Siyoung Q.; Choi, Myung Chul; Kim, Mahn Won

    2015-03-01

    In this paper, we report on an experimental investigation of a shape-controlled percolation transition in two-dimensional (2D) amorphous packing of dimers without long-range order. In the maximally random jammed (MRJ) packing of asymmetric dimers consisting of head and body, a dramatic increase in the connectivity of heads upon increasing the head-to-body size ratio γ leads to a percolation transition of the heads at the well-defined percolation threshold. In comparison with binary disks, the existence of a bond in dimers causes the heads to be homogeneously distributed over a system by inhibiting the local segregation. Interestingly, we found, however, that the cluster structure at the percolation threshold is insensitive to the bond, even though the existence of the bonds affects the percolation threshold as well as the head distribution. The fractal dimensions at the percolation threshold obey the universal law of the 2D percolation theory independently of the existence of bonds. Our finding can provide us with a new perspective of interesting applications of randomly assembled binary composites by using the homogeneous particle distribution and the sensitively tunable connectivity under particle shape control.

  13. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    PubMed

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  14. Adjunctive mirror exposure for eating disorders: a randomized controlled pilot study.

    PubMed

    Hildebrandt, Tom; Loeb, Katharine; Troupe, Sara; Delinsky, Sherrie

    2012-12-01

    Mirror exposure therapy has proven efficacious in improving body image among individuals with shape/weight concerns and eating disorders. No randomized controlled trials have examined the effect of mirror exposure in a healthy-weight clinical sample of eating disordered individuals. The purpose of the current study was to test the efficacy of a five-session acceptance based mirror exposure therapy (A-MET) versus a non directive body image therapy (ND) control as an adjunctive treatment to outpatient eating disorder treatment. Thirty-three males and females aged 14-65 with a body mass index of 18.5-29.9 were randomized to five sessions of A-MET or ND with a 1-month follow-up. Results indicated large to moderate effect size differences for efficacy of A-MET across measures of body checking, body image dissatisfaction, and eating disorder symptoms (d = -0.38 to -1.61) at end of treatment and follow-up. Baseline measures of social comparison and history of appearance-related teasing were predictive of treatment response. There were also differential effects of treatment on participants' perceived homework quality, but no differences in therapeutic alliance. Results suggest that A-MET is a promising adjunctive treatment for residual body image disturbance among normal and overweight individuals undergoing treatment for an eating disorder. Future research and clinical implications are discussed.

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

    PubMed Central

    2014-01-01

    Background Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke. Methods/Design In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events. Discussion This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function. Trial registration Chinese Clinical Trial Registry ChiCTR-TRC-12001971. PMID:24908241

  16. A randomized controlled trial to increase information, motivation, and behavioral skills in Ugandan adolescents

    PubMed Central

    Ybarra, Michele L.; Korchmaros, Josephine D.; Prescott, Tonya L.; Birungi, Ruth

    2015-01-01

    Background One in twenty-five Ugandan adolescents is HIV positive. Purpose Examine the impact of an Internet-based HIV prevention program on Information-Motivation-Behavior Skills Model-related constructs. Methods Three hundred and sixty-six sexually experienced and inexperienced students 12-18+ years-old in Mbarara, Uganda were randomly assigned to: the five-lesson CyberSenga program or treatment-as-usual. Half of the intervention participants were further randomized to a booster session. Assessments were collected at three and six months post-baseline. Results Participants’ HIV-related information improved over time at a greater rate for the intervention groups compared to the control group. Motivation for condom use changed to a greater degree over time for the intervention group – especially those in the intervention+booster group - compared to the control group. Behavioral skills for condom use, and motivation and behavioral skills for abstinence were statistically similar over time for both groups. Conclusions CyberSenga improves HIV preventive information and motivation to use condoms. PMID:25633626

  17. Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Laparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published. Methods/Design This is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management. The primary study endpoint is the length of postoperative hospital stay in days. Sample size was estimated based on preliminary retrospective cohort, which suggested that 102 patients would provide 80% power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05. Secondary endpoints include passage of stool, commencement of enteral nutrition, 30-day mortality, complications, postoperative pain, and the length of sick leave. Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up. Long-term follow-up by letter or telephone interview will take place at 1, 5, and 10 years. Discussion To the best of our knowledge, this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction. Trial registration ClinicalTrials.gov identifier: NCT01867528. Date of registration May 26th 2013. PMID:25306234

  18. Group critical incident stress debriefing with emergency services personnel: a randomized controlled trial.

    PubMed

    Tuckey, Michelle R; Scott, Jill E

    2014-01-01

    Although single-session individual debriefing is contraindicated, the efficacy of group psychological debriefing remains unresolved. We conducted the first randomized controlled trial of critical incident stress debriefing (CISD) with emergency workers (67 volunteer fire-fighters) following shared exposure to an occupational potentially traumatic event (PTE). The goals of group CISD are to prevent post-traumatic stress and promote return to normal functioning following a PTE. To assess both goals we measured four outcomes, before and after the intervention: post-traumatic stress, psychological distress, quality of life, and alcohol use. Fire brigades were randomly assigned to one of three treatment conditions: (1) CISD, (2) Screening (i.e., no-treatment), or (3) stress management Education. Controlling for pre-intervention scores, CISD was associated with significantly less alcohol use post-intervention relative to Screening, and significantly greater post-intervention quality of life relative to Education. There were no significant effects on post-traumatic stress or psychological distress. Overall, CISD may benefit broader functioning following exposure to work-related PTEs. Future research should focus on individual, group, and organizational factors and processes that can promote recovery from operational stressors. Ultimately, an occupational health (rather than victim-based) approach will provide the best framework for understanding and combating potential threats to the health and well-being of workers at high risk for PTE exposure. PMID:23799773

  19. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials

    PubMed Central

    Doyle, Orla; McGlanaghy, Edel; O’Farrelly, Christine; Tremblay, Richard E.

    2016-01-01

    This study examined the impact of a targeted Irish early intervention program on children’s emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally. Trial Registration: ISRCTN Registry ISRCTN04631728 PMID:27253184

  20. Effects of resistance training on sarcopenic obesity index in older women: A randomized controlled trial.

    PubMed

    Gadelha, André Bonadias; Paiva, Flávio Macedo Lahud; Gauche, Rafael; de Oliveira, Ricardo Jacó; Lima, Ricardo Moreno

    2016-01-01

    The purpose of this study was to examine the effects of resistance training (RT) on sarcopenic obesity (SO) in older women. 243 older women underwent body composition measurement using dual-energy X-ray absorptiometry, and the SO index was calculated. This randomized controlled trial adopted from the baseline sample, 113 volunteers (67.0±5.2years) were randomly assigned to a control group (CG, n=64) or an experimental group (EG, n=69). The EG took part in a 24-week RT program, conducted three times per week. Body composition measurements were repeated at the end of the training program. RT induced a significant increase in fat-free mass (P<0.01), but not decrease in fat mass in the EG. Moreover, the SO index was also significantly improved in the EG (P<0.01), while it decreased significantly in the CG (P<0.01). It is concluded that RT is an effective approach to promote body composition alterations in older women, and it might improve SO-related phenotypes. PMID:27057600

  1. Comparative efficacy of aloe vera mouthwash and chlorhexidine on periodontal health: A randomized controlled trial

    PubMed Central

    Jha, Abhishek; Bhashyam, Mamtha

    2016-01-01

    Background With introduction of many herbal medicines, dentistry has recently evidenced shift of approach for treating many inflammatory oral diseases by using such modalities. Aloe vera is one such product exhibiting multiple benefits and has gained considerable importance in clinical research recently. Aim To compare the efficacy of Aloevera and Chlorhexidine mouthwash on Periodontal Health. Material and Methods Thirty days randomized controlled trial was conducted among 390 dental students. The students were randomized into two intervention groups namely Aloe Vera (AV) chlorhexidine group (CHX) and one control (placebo) group. Plaque index and gingival index was recorded for each participant at baseline, 15 days and 30 days. The findings were than statistically analyzed, ANOVA and Post Hoc test were used. Results There was significant reduction (p<0.05) in the mean scores of all the parameters with Aloe Vera (AV) and chlorhexidine group. Post hoc test showed significant difference (p<0.000) in mean plaque and gingival index scores of aloe Vera and placebo and chlorhexidine and placebo group. No significant difference (p<0.05) was observed between AloeVera and chlorhexidine group. Conclusions Being an herbal product AloeVera has shown equal effectiveness as Chlorhexidine. Hence can be used as an alternative product for curing and preventing gingivitis. Key words:Aloe vera, chlorhexidine, dental plaque, gingivitis. PMID:27703614

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

    PubMed Central

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

    2015-01-01

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

  3. Effect of management training in organizational justice: a randomized controlled trial

    PubMed Central

    NAKAMURA, Saki; SOMEMURA, Hironori; SASAKI, Norio; YAMAMOTO, Megumi; TANAKA, Mika; TANAKA, Katsutoshi

    2016-01-01

    Organizational justice (OJ) influences the well-being of employees of organizations. We conducted a randomized controlled trial to examine whether or not brief management training increases OJ for subordinates. Study participants were managers and subordinates working in the private manufacturing sector. Randomization at the departmental level generated an intervention group of 23 departments (93 managers and 248 subordinates) and a control group of 23 departments (91 managers and 314 subordinates). Managers in the intervention group received a 90-min training session to investigate the attitudes and behavior of managers and help increase OJ. Subordinates completed self-administered OJ questionnaire surveys on procedural, interpersonal, and informational justice before and 3 months after intervention. For all subordinates, the interaction between group and time in OJ scores obtained before and 3 months after intervention were not significant. However, in subgroup analyses of the lowest tertile group in relation to the baseline of each of the three OJ subscales and total scores, the lowest tertile group of the interpersonal justice subscale showed significant improvement. The results of this study suggest that brief management training in OJ for managers significantly improves a low rating from subordinates in interpersonal justice. Further studies are required to develop a specific intervention method to increase OJ. PMID:26860786

  4. Effect of ozonated oil and chlorhexidine gel on plaque induced gingivitis: A randomized control clinical trial

    PubMed Central

    Indurkar, Maya Sanjeev; Verma, Renu

    2016-01-01

    Background: Several chemotherapeutic agents have been developed to prevent gingivitis and its progression into periodontitis. In this present study, the efficacy of ozonated oil and chlorhexidine gel was assessed and compared on plaque induced gingivitis. Aim: To evaluate the effect of ozonated oil on plaque induced gingivitis and to compare its efficacy with chlorhexidine gel. Materials and Methods: A total of 20 subjects, aged from 18 to 65 years, with plaque-induced gingivitis were selected from the outpatient Department of Periodontology, Government Dental College and Hospital, Aurangabad, for this study. They were divided randomly into the test or ozonated oil group (Group I) and the control or chlorhexidine gel group (Group II) with 10 subjects in each group. Subjects were randomly assigned to massage their gingiva thrice a day for 3 weeks with ozonated oil (test), and chlorhexidine gel (control). Plaque index and gingival index scores were recorded for the 20 subjects at baseline and after 3 weeks. Results: Ozonated oil (Group I) and chlorhexidine gel (Group II) groups showed statistically significant differences with respect to plaque index and gingival index, from the baseline to 3 weeks (P < 0.001 in both). But the difference between Group I and Group II, at the end of the study period, was not statistically significant with respect to the plaque index and gingival index. Conclusions: The ozonated oil and chlorhexidine gel, both can be used as an effective agent in maintaining and improving gingival health. PMID:27041835

  5. 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

  6. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: A Randomized Controlled Trial

    PubMed Central

    Farchione, Todd J.; Fairholme, Christopher P.; Ellard, Kristen K.; Boisseau, Christina L.; Thompson-Hollands, Johanna; Carl, Jenna R.; Gallagher, Matthew W.; Barlow, David H.

    2012-01-01

    This study further evaluates the efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP). A diagnostically heterogeneous clinical sample of 37 patients with a principal anxiety disorder diagnosis was enrolled in a randomized controlled trial (RCT) involving up to 18 sessions of treatment and a 6-month follow-up period. Patients were randomly assigned to receive either immediate treatment with the UP (n=26) or delayed treatment, following a 16-week wait-list control period (WLC; n= 11). The UP resulted in significant improvement on measures of clinical severity, general symptoms of depression and anxiety, levels of negative and positive affect, and a measure of symptom interference in daily functioning across diagnoses. In comparison, participants in the WLC condition exhibited little to no change following the 16-week wait-list period. The effects of UP treatment were maintained over the 6-month follow-up period. Results from this RCT provide additional evidence for the efficacy of the UP in the treatment of anxiety and comorbid depressive disorders, and provide additional support for a transdiagnostic approach to the treatment of emotional disorders. PMID:22697453

  7. Is EEG-biofeedback an effective treatment in autism spectrum disorders? A randomized controlled trial.

    PubMed

    Kouijzer, Mirjam E J; van Schie, Hein T; Gerrits, Berrie J L; Buitelaar, Jan K; de Moor, Jan M H

    2013-03-01

    EEG-biofeedback has been reported to reduce symptoms of autism spectrum disorders (ASD) in several studies. However, these studies did not control for nonspecific effects of EEG-biofeedback and did not distinguish between participants who succeeded in influencing their own EEG activity and participants who did not. To overcome these methodological shortcomings, this study evaluated the effects of EEG-biofeedback in ASD in a randomized pretest-posttest control group design with blinded active comparator and six months follow-up. Thirty-eight participants were randomly allocated to the EEG-biofeedback, skin conductance (SC)-biofeedback or waiting list group. EEG- and SC-biofeedback sessions were similar and participants were blinded to the type of feedback they received. Assessments pre-treatment, post-treatment, and after 6 months included parent ratings of symptoms of ASD, executive function tasks, and 19-channel EEG recordings. Fifty-four percent of the participants significantly reduced delta and/or theta power during EEG-biofeedback sessions and were identified as EEG-regulators. In these EEG-regulators, no statistically significant reductions of symptoms of ASD were observed, but they showed significant improvement in cognitive flexibility as compared to participants who managed to regulate SC. EEG-biofeedback seems to be an applicable tool to regulate EEG activity and has specific effects on cognitive flexibility, but it did not result in significant reductions in symptoms of ASD. An important finding was that no nonspecific effects of EEG-biofeedback were demonstrated.

  8. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    PubMed

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. PMID:26121535

  9. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial.

    PubMed

    Farchione, Todd J; Fairholme, Christopher P; Ellard, Kristen K; Boisseau, Christina L; Thompson-Hollands, Johanna; Carl, Jenna R; Gallagher, Matthew W; Barlow, David H

    2012-09-01

    This study further evaluates the efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP). A diagnostically heterogeneous clinical sample of 37 patients with a principal anxiety disorder diagnosis was enrolled in a randomized controlled trial (RCT) involving up to 18 sessions of treatment and a 6-month follow-up period. Patients were randomly assigned to receive either immediate treatment with the UP (n=26) or delayed treatment, following a 16-week wait-list control period (WLC; n=11). The UP resulted in significant improvement on measures of clinical severity, general symptoms of depression and anxiety, levels of negative and positive affect, and a measure of symptom interference in daily functioning across diagnoses. In comparison, participants in the WLC condition exhibited little to no change following the 16-week wait-list period. The effects of UP treatment were maintained over the 6-month follow-up period. Results from this RCT provide additional evidence for the efficacy of the UP in the treatment of anxiety and comorbid depressive disorders, and provide additional support for a transdiagnostic approach to the treatment of emotional disorders.

  10. Does Encouragement Matter in Improving Gender Imbalances in Technical Fields? Evidence from a Randomized Controlled Trial

    PubMed Central

    Unkovic, Cait; Sen, Maya; Quinn, Kevin M.

    2016-01-01

    Does encouragement help address gender imbalances in technical fields? We present the results of one of the first and largest randomized controlled trials on the topic. Using an applied statistics conference in the social sciences as our context, we randomly assigned half of a pool of 3,945 graduate students to receive two personalized emails encouraging them to apply (n = 1,976) and the other half to receive nothing (n = 1,969). We find a robust, positive effect associated with this simple intervention and suggestive evidence that women responded more strongly than men. However, we find that women’s conference acceptance rates are higher within the control group than in the treated group. This is not the case for men. The reason appears to be that female applicants in the treated group solicited supporting letters at lower rates. Our findings therefore suggest that “low dose” interventions may promote diversity in STEM fields but may also have the potential to expose underlying disparities when used alone or in a non-targeted way. PMID:27097315

  11. Herbal Medicines for Treating Metabolic Syndrome: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Ko, Youme; Sasaki, Yui; Hwang, Eui-Hyoung; Song, Yun-Kyung; Shin, Yong-Cheol

    2016-01-01

    Objective. The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines in the management of metabolic syndrome. Materials and Methods. On December 9, 2015, we searched PubMed, EMBASE, Cochrane Library, SCOPUS, AMED, CNKI, KoreaMed, KMBASE, OASIS, and J-STAGE with no restriction on language or published year. We selected randomized controlled trials that involved patients with metabolic syndrome being treated with herbal medicines as intervention. The main keywords were “Chinese herbal medicines”, “metabolic syndrome”, and “randomized controlled trials”. Herbal substances which were not based on East Asian medical theory, combination therapy with western medicines, and concurrent diseases other than metabolic syndrome were excluded. The risk of bias was assessed by Cochrane's “Risk of Bias” tool. The protocol or review was registered in PROSPERO (an international prospective register of systematic reviews) (CRD42014006842). Results. From 1,098 articles, 12 RCTs were included in this review: five trials studied herbal medicines versus a placebo or no treatment, and seven trials studied herbal medicines versus western medicines. Herbal medicines were effective on decreasing waist circumference, blood glucose, blood lipids, and blood pressure. Conclusion. This study suggests the possibility that herbal medicines can be complementary and alternative medicines for metabolic syndrome. PMID:27413388

  12. Qualitative Contributions to a Randomized Controlled Trial Addressing HIV/AIDS-Stigma in Medical Students

    PubMed Central

    Marzán-Rodríguez, Melissa; Varas-Díaz, Nelson; Neilands, Torsten

    2016-01-01

    Specialized training for healthcare professionals (HCP) in order to reduce HIV/AIDS related stigma must be part of a public health model for HIV/AIDS. Tested interventions to reduce HIV/AIDS related stigma among HCP have been mostly absent from these efforts. A qualitative approach was used to assess stigma reduction within a traditional randomized controlled design in order to better understand how our current stigma intervention worked and was understood by 2nd year medical students. After conducting a quantitative follow up survey one-year post intervention we conducted 20 in-depth qualitative interviews with a subsample of our intervention group participants as part of the overall evaluation process. Once the interviews were finished, we transcribed them and used NVivo (v.8) to organized the qualitative data. In the process of analyzing the qualitative data we identified core intervention areas participants described as useful for their training and development: (1) acquiring more HIV/AIDS-related knowledge, (2) increased skills for management of high stigma situations, and (3) the ability to identify socio-structural factors that foster HIV infection among clients. The gathered information is important in order to have a deep understanding of how attitudinal change happens as part of our intervention strategies. Keywords: HIV/AIDS, Stigma, Randomized Controlled Trial, Qualitative Evaluation, Medical Students, Puerto Rico PMID:26855975

  13. Does Encouragement Matter in Improving Gender Imbalances in Technical Fields? Evidence from a Randomized Controlled Trial.

    PubMed

    Unkovic, Cait; Sen, Maya; Quinn, Kevin M

    2016-01-01

    Does encouragement help address gender imbalances in technical fields? We present the results of one of the first and largest randomized controlled trials on the topic. Using an applied statistics conference in the social sciences as our context, we randomly assigned half of a pool of 3,945 graduate students to receive two personalized emails encouraging them to apply (n = 1,976) and the other half to receive nothing (n = 1,969). We find a robust, positive effect associated with this simple intervention and suggestive evidence that women responded more strongly than men. However, we find that women's conference acceptance rates are higher within the control group than in the treated group. This is not the case for men. The reason appears to be that female applicants in the treated group solicited supporting letters at lower rates. Our findings therefore suggest that "low dose" interventions may promote diversity in STEM fields but may also have the potential to expose underlying disparities when used alone or in a non-targeted way. PMID:27097315

  14. A randomized controlled trial of the effect of dietary fibre on blood pressure.

    PubMed

    Margetts, B M; Beilin, L J; Vandongen, R; Armstrong, B K

    1987-03-01

    Eighty-eight healthy omnivores with normal blood pressure participated in a randomized, controlled, cross-over trial of the effect on blood pressure of increasing dietary fibre intake. Subjects were randomly allocated to a control group eating a low fibre diet throughout, or to one of two experimental groups eating a high fibre diet for one of two 6-week experimental periods. Changes in body weight, other dietary constituents and lifestyle factors were avoided as far as possible. Twenty-four hour diet records showed a substantial increase in dietary fibre when subjects were on the high fibre diet. There was no consistent effect of change in dietary fibre intake on group mean systoloic or diastolic blood pressures. Adjusting blood pressures for changes in other dietary components, plasma lipids, electrolytes, body weight and other lifestyle variables did not alter this result. These findings do not support the hypothesis that the blood pressure lowering effect of a vegetarian diet is solely due to an increase in fibre intake.

  15. Video-Assisted Thoracoscopic Sympathectomy for Palmar Hyperhidrosis: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Zhang, Wenxiong; Yu, Dongliang; Jiang, Han; Xu, Jianjun; Wei, Yiping

    2016-01-01

    Objectives Video-assisted thoracoscopic sympathectomy (VTS) is effective in treating palmar hyperhidrosis (PH). However, it is no consensus over which segment should undergo VTS to maximize efficacy and minimize the complications of compensatory hyperhidrosis (CH). This study was designed to compare the efficiency and side effects of VTS of different segments in the treatment of PH. Methods A comprehensive search of PubMed, Ovid MEDLINE, EMBASE, Web of Science, ScienceDirect, the Cochrane Library, Scopus and Google Scholar was performed to identify studies comparing VTS of different segments for treatment of PH. The data was analyzed by Revman 5.3 software and SPSS 18.0. Results A total of eight randomized controlled trials (RCTs) involving 1200 patients were included. Meta-analysis showed that single segment/low segments VTS could reduce the risk of moderate/severe CH compared with multiple segments/high segments. The risk of total CH had a similar trend. In the subgroup analysis of single segment VTS, no significant differences were found between T2/T3 VTS and other segments in postoperative CH and degree of CH. T4 VTS showed better efficacy in limiting CH compared with other segments. Conclusions T4 appears to be the best segment for the surgical treatment of PH. Our findings require further validation in more high-quality, large-scale randomized controlled trials. PMID:27187774

  16. Herbal Medicines for Treating Metabolic Syndrome: A Systematic Review of Randomized Controlled Trials.

    PubMed

    Jang, Soobin; Jang, Bo-Hyoung; Ko, Youme; Sasaki, Yui; Park, Jeong-Su; Hwang, Eui-Hyoung; Song, Yun-Kyung; Shin, Yong-Cheol; Ko, Seong-Gyu

    2016-01-01

    Objective. The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines in the management of metabolic syndrome. Materials and Methods. On December 9, 2015, we searched PubMed, EMBASE, Cochrane Library, SCOPUS, AMED, CNKI, KoreaMed, KMBASE, OASIS, and J-STAGE with no restriction on language or published year. We selected randomized controlled trials that involved patients with metabolic syndrome being treated with herbal medicines as intervention. The main keywords were "Chinese herbal medicines", "metabolic syndrome", and "randomized controlled trials". Herbal substances which were not based on East Asian medical theory, combination therapy with western medicines, and concurrent diseases other than metabolic syndrome were excluded. The risk of bias was assessed by Cochrane's "Risk of Bias" tool. The protocol or review was registered in PROSPERO (an international prospective register of systematic reviews) (CRD42014006842). Results. From 1,098 articles, 12 RCTs were included in this review: five trials studied herbal medicines versus a placebo or no treatment, and seven trials studied herbal medicines versus western medicines. Herbal medicines were effective on decreasing waist circumference, blood glucose, blood lipids, and blood pressure. Conclusion. This study suggests the possibility that herbal medicines can be complementary and alternative medicines for metabolic syndrome. PMID:27413388

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

    PubMed Central

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

    2014-01-01

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

  18. Gate controllable resistive random access memory devices using reduced graphene oxide

    NASA Astrophysics Data System (ADS)

    Hazra, Preetam; Resmi, A. N.; Jinesh, K. B.

    2016-04-01

    The biggest challenge in the resistive random access memory (ReRAM) technology is that the basic operational parameters, such as the set and reset voltages, the current on-off ratios (hence the power), and their operational speeds, strongly depend on the active and electrode materials and their processing methods. Therefore, for its actual technological implementations, the unification of the operational parameters of the ReRAM devices appears to be a difficult task. In this letter, we show that by fabricating a resistive memory device in a thin film transistor configuration and thus applying an external gate bias, we can control the switching voltage very accurately. Taking partially reduced graphene oxide, the gate controllable switching is demonstrated, and the possible mechanisms are discussed.

  19. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer.

    PubMed

    Monti, Daniel A; Peterson, Caroline; Kunkel, Elisabeth J Shakin; Hauck, Walter W; Pequignot, Edward; Rhodes, Lora; Brainard, George C

    2006-05-01

    The purpose of this study was to gather data on the efficacy of a newly developed psychosocial group intervention for cancer patients, called mindfulness-based art therapy (MBAT). One hundred and eleven women with a variety of cancer diagnoses were paired by age and randomized to either an eight-week MBAT intervention group or a wait-list control group. Ninety-three participants (84%) completed both the pre- and post-study measurements. As compared to the control group, the MBAT group demonstrated a significant decrease in symptoms of distress (as measured by the Symptoms Checklist-90-Revised) and significant improvements in key aspects of health-related quality of life (as measured by the Medical Outcomes Study Short-Form Health Survey). This investigation of MBAT provides initial encouraging data that support a possible future role for the intervention as a psychosocial treatment option for cancer patients.

  20. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    PubMed

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179