Teaching Social-Communication Skills to Preschoolers with Autism: Efficacy of Video versus in Vivo Modeling in the Classroom

ERIC Educational Resources Information Center

Wilson, Kaitlyn P.

2013-01-01

Video modeling is a time- and cost-efficient intervention that has been proven effective for children with autism spectrum disorder (ASD); however, the comparative efficacy of this intervention has not been examined in the classroom setting. The present study examines the relative efficacy of video modeling as compared to the more widely-used…

Efficacy of terbinafine compared to lanoconazole and luliconazole in the topical treatment of dermatophytosis in a guinea pig model.

PubMed

Ghannoum, M A; Long, L; Kim, H G; Cirino, A J; Miller, A R; Mallefet, P

2010-05-01

The in vivo efficacy of terbinafine was compared to lanoconazole and luliconazole in the topical treatment of dermatophytosis caused by Trichophyton mentagrophytes using a guinea pig model. Topical antifungal treatment commenced three days post-infection, and each agent was applied once daily for seven consecutive days. Upon completion of the treatment period, evaluations of clinical and mycological efficacies were performed, as was scanning electron microscopy (SEM) analyses. Data showed that while all tested antifungals demonstrated significant mycological efficacy in terms of eradicating the fungi over untreated control, terbinafine and luliconazole showed superior clinical efficacy compared to lanoconazole (P-values < 0.001 & 0.003, respectively). Terbinafine demonstrated the highest clinical percent efficacy. SEM analysis revealed hairs from terbinafine and lanoconazole-treated animals had near complete clearance of fungi, while samples from luliconazole-treated animals were covered with debris and few conidia. This study demonstrates that, in general, terbinafine possessed similar efficacy to lanoconazole and luliconazole in the treatment of dermatophytosis. Terbinafine tended to have superior clinical efficacy compared to the azoles tested, although this difference was not statistically significant against luliconazole. This apparent superiority may be due to the fungicidal activity of terbinafine compared to the fungistatic effect of the other two drugs.

Citalopram and escitalopram in the treatment of major depressive disorder: a pooled analysis of 3 clinical trials.

PubMed

Li, Huafang; Li, Ting; Li, Guanjun; Luo, Jianfeng

2014-11-01

Pooled analysis is a powerful technique that is increasingly used to detect differences in efficacy between pharmacologic agents. Some studies have compared the efficacy and tolerability of citalopram and escitalopram, with contradictory results. The aim of this study was to compare the efficacy and tolerability of citalopram and escitalopram in the treatment of major depressive disorder (MDD) using pooled analyses. Data from 3 randomized, double-blind studies that compared citalopram (20 to 40 mg/d) and escitalopram (10 to 20 mg/d) were pooled and analyzed. The primary efficacy parameter was change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score. Efficacy assessments were made at weeks 0 (baseline), 1, 2, 4, and 6. Based on the mean change from baseline in the HAM-D-17 at weeks 1, 2, 4, and 6, the efficacy of citalopram, 20 to 40 mg/d, was equivalent to escitalopram, 10 to 20 mg/d (P > .05). Similar results were seen for severely depressed patients, with a mean treatment difference of 13.9 (SE = 7.6) vs 15.9 (SE = 7.5). Response and remission rates at week 6 were similar (response, 72.4% for citalopram, compared with 73.5% for escitalopram; remission, 52.6% vs 54.5%, respectively). The pooled analysis showed that over a 6-week treatment period, citalopram, 20 to 40 mg/d, is equivalent to escitalopram, 10 to 20 mg/d, in both efficacy and tolerability.

Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study.

PubMed

Hyun, M Y; Lee, Y; No, Y A; Yoo, K H; Kim, M N; Hong, C K; Chang, S E; Won, C H; Kim, B J

2015-03-01

Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds. In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events. At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases. PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. © 2014 British Association of Dermatologists.

Teacher Leadership and Teacher Efficacy: A Correlational Study Comparing Teacher Perceptions of Leadership and Efficacy and Teacher Evaluation Scores from the North Carolina Educator Evaluation System

ERIC Educational Resources Information Center

Guenzler, April M.

2016-01-01

This study sought to identify correlations between constructs of teacher leadership, teacher efficacy, and teacher evaluation. Teacher perceptual data of support of teacher leadership, perceptual data on personal teacher efficacy, and teacher self-reported scores from the North Carolina Educator Evaluation System were gathered. The relationships…

A Comparative Study of Pre-Service Teachers' Teaching Efficacy Beliefs before and after Work-Integrated Learning: Part Two

ERIC Educational Resources Information Center

Junqueira, K. E.; Matoti, S. N.

2013-01-01

The study, which is grounded in Bandura's concept of self-efficacy, assessed the teaching efficacy beliefs of student teachers before and after completing six months of work-integrated learning. This was necessitated by research which shows that self-efficacy is an important aspect which influences a teacher's ability to teach as well as the…

A comparative study of self-efficacy, outcome expectancy, and retention of beginning urban science teachers

NASA Astrophysics Data System (ADS)

Klein, Nina

The purpose of the multi-tiered study presented is to compare the effect of credentialing route on the self-efficacy, outcome expectancy, and retention of beginning urban science teachers serving students in a large urban school district in Southern California. Candidates from one traditional, university-based teacher education program and from two alternative programs, the Teach for America and District Intern Programs, were surveyed and interviewed during the second semester of their first year of teaching. To determine the potential of a difference in self-efficacy and outcome expectancy, the study gave teachers a modified version of the Science Teachers' Efficacy Belief Instrument (STEBI), developed and validated by Riggs and Enochs (1989). Two representative candidates from each program were then interviewed in order to probe for deeper understanding of possible sources of their efficacy and outcome expectancy. The final part of the study is an evaluation of retention data from the three programs, each to triangulate this information with data collected from the surveys, and comparing these retention rates with published data. The study provides data on unresearched questions about traditionally and alternatively credentialed science teachers in urban settings in California.

Investigating the Efficacy of Practical Skill Teaching: A Pilot-Study Comparing Three Educational Methods

ERIC Educational Resources Information Center

Maloney, Stephen; Storr, Michael; Paynter, Sophie; Morgan, Prue; Ilic, Dragan

2013-01-01

Effective education of practical skills can alter clinician behaviour, positively influence patient outcomes, and reduce the risk of patient harm. This study compares the efficacy of two innovative practical skill teaching methods, against a traditional teaching method. Year three pre-clinical physiotherapy students consented to participate in a…

Comparing maternal breastfeeding self-efficacy during first week and sixth week postpartum

PubMed Central

Pakseresht, Sedighe; Pourshaban, Farzane; khalesi, Zahra Bostani

2017-01-01

Introduction The ideal nourishment for the first 12 months of a child’s life comes from breastfeeding its mother’s milk, and maternal self-efficacy is one factor which affects breastfeeding duration. Therefore, the present study aimed to compare the maternal breastfeeding self-efficacy during the first week and sixth-week postpartum. Methods This descriptive, analytical study was conducted on 767 women referring to the Family Health Research Center of Rasht in 2014. Mothers were selected through continuous sampling. For data collection, we used demographic questionnaires, and Dennis breastfeeding self-efficacy scale. For data analysis, Chi-square, Mann-Whitney U, Pearson’s correlation coefficient and multiple regression were performed using SPSS version 19. Results In this study, most mothers had scores compatible with moderate self-efficacy in the first week, and in the sixth week had high self-efficacy for breastfeeding. There was a significant relationship between breastfeeding self-efficacy (BSE) score and employment status (p<0.0001). Also, we found significant BSE score differences between primiparous and multiparous women (p<0.001). Conclusion Results of the study indicate that breastfeeding duration increases the breastfeeding self-efficacy levels. So, Developing and implementing appropriate approaches are needed to improve breastfeeding duration in mothers. PMID:28465802

[Study on material base of Carthamus tinctorius with antioxidant effect based on selective knock-out].

PubMed

Wang, Lin-Yan; Tang, Yu-Ping; Liu, Xin; Ge, Ya-Hui; Li, Shu-Jiao; Shang, Er-Xin; Duan, Jin-Ao

2014-04-01

To establish a method for studying efficacious materials of traditional Chinese medicines from an overall perspective. Carthamus tinctorius was taken the example. Its major components were depleted by preparing liquid chromatography. Afterwards, the samples with major components depleted were evaluated for their antioxidant effect, so as to compare and analyze the major efficacious materials of C. tinctorius with antioxidant activity and the contributions. Seven major components were depleted from C. tinctorius samples, and six of them were identified with MS data and control comparison. After all of the samples including depleted materials are compared and evaluated for their antioxidant effect, the findings showed that hydroxysafflor yellow A, anhydrosafflor yellow B and 6-hydroxykaempferol-3, 6-di-O-glucoside-7-O-glucuronide were the major efficacious materials. This study explored a novel and effective method for studying efficacious materials of traditional Chinese medicines. Through this method, we could explain the direct and indirect contributions of different components to the efficacy of traditional Chinese medicines, and make the efficacious material expression of traditional Chinese medicines clearer.

Patterns of Self-Efficacy among College Students in Developmental Reading

ERIC Educational Resources Information Center

Cantrell, Susan Chambers; Correll, Pamela; Clouse, Jane; Creech, Kimberly; Bridges, Sharon; Owens, Danielle

2013-01-01

In this study, we investigated the self-efficacy beliefs and sources of self-efficacy among first-year college students placed in developmental reading courses. Students enrolled in developmental reading were compared to students who were not placed in developmental reading courses in terms of self-efficacy in various contexts and sources of…

Self-efficacy, pros, and cons as variables associated with adjacent stages of change for regular exercise in Japanese college students.

PubMed

Horiuchi, Satoshi; Tsuda, Akira; Kobayashi, Hisanori; Fallon, Elizabeth A; Sakano, Yuji

2017-07-01

This study examined self-efficacy (confidence to exercise), pros (exercise's advantages), and cons (exercise's disadvantages) as variables associated across the transtheoretical model's six stages of change in 403 Japanese college students. A series of logistic regression analyses were conducted. Results showed that higher pros and lower cons were associated with being in contemplation compared to precontemplation. Lower cons were associated with being in preparation compared to contemplation. Higher self-efficacy was associated with being in action compared to preparation as well as being in maintenance compared to action. Lower cons were associated with being in termination compared to maintenance.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population.

PubMed

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population

PubMed Central

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

Background The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Methods Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Results Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Conclusion Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding. PMID:28553116

Empowering the Middle: A High School Study Skills Program and Its Impact on Academic Achievement and Self-Efficacy

ERIC Educational Resources Information Center

Simmons, Stephanie Yvette

2017-01-01

This study examined the impact of a self-regulatory skills course on the academic achievement and self-efficacy of 11th-grade students. The researcher compared intervention and control groups participants' pre- and posttest scores on the General Self-Efficacy Scale and the Learning and Study Skills Assessment Inventory-High School version. Scores…

The Relationship between Statistics Self-Efficacy, Statistics Anxiety, and Performance in an Introductory Graduate Statistics Course

ERIC Educational Resources Information Center

Schneider, William R.

2011-01-01

The purpose of this study was to determine the relationship between statistics self-efficacy, statistics anxiety, and performance in introductory graduate statistics courses. The study design compared two statistics self-efficacy measures developed by Finney and Schraw (2003), a statistics anxiety measure developed by Cruise and Wilkins (1980),…

A randomized trial to study the comparative efficacy of phenylbutyrate and benzoate on nitrogen excretion and ureagenesis in healthy volunteers

PubMed Central

Nagamani, Sandesh C.S.; Agarwal, Umang; Tam, Allison; Azamian, Mahshid; McMeans, Ann; Didelija, Inka C.; Mohammad, Mahmoud A.; Marini, Juan C.

2017-01-01

Summary Purpose Benzoate and phenylbutyrate are widely used in the treatment of urea cycle disorders, but detailed studies on pharmacokinetics and comparative efficacy on nitrogen excretion are lacking. Methods We conducted a randomized, three arm, crossover trial in healthy volunteers to study pharmacokinetics and comparative efficacy of phenylbutyrate (NaPB; 7.15 g•m−2BSA•day−1), benzoate (NaBz; 5.5 g•m−2BSA•day−1), and a combination of two medications (MIX arm; 3.575 g NaPB and 2.75 g NaBz•m−2BSA•day−1) on nitrogen excretion. Stable isotopes were used to study effects on urea production and dietary nitrogen disposal. Results The conjugation efficacy for both phenylbutyrate and benzoate was 65%; conjugation was superior at the lower dose used in the MIX arm. Whereas NaPB and MIX treatments were more effective at excreting nitrogen than NaBz, nitrogen excretion as a drug conjugate was similar between phenylbutyrate and MIX arms. Nitrogen-excreted-per-USD was higher with combination therapy compared to NaPB. Conclusions Phenylbutyrate was more effective than benzoate at disposing nitrogen. Increasing phenylbutyrate dose may not result in higher nitrogen excretion due to decreased conjugation efficiency at higher doses. Combinatorial therapy with phenylbutyrate and benzoate has the potential to significantly decrease treatment cost without compromising the nitrogen disposal efficacy. PMID:29693650

Long-term Persistence of Zoster Vaccine Efficacy

PubMed Central

Morrison, Vicki A.; Johnson, Gary R.; Schmader, Kenneth E.; Levin, Myron J.; Zhang, Jane H.; Looney, David J.; Betts, Robert; Gelb, Larry; Guatelli, John C.; Harbecke, Ruth; Pachucki, Connie; Keay, Susan; Menzies, Barbara; Griffin, Marie R.; Kauffman, Carol A.; Marques, Adriana; Toney, John; Boardman, Kathy; Su, Shu-Chih; Li, Xiaoming; Chan, Ivan S. F.; Parrino, Janie; Annunziato, Paula; Oxman, Michael N.; Davis, LE.; Kauffman, CA; Keay, SK; Straus, SE; Marques, AR; Soto, NE; Brunell, P; Gnann, JW; Serrao, R; Cotton, DJ; Goodman, RP; Arbeit, RD; Pachucki, CT; Levin, MJ; Schmader, KE; Keitel, WA; Greenberg, RN; Morrison, VA; Wright, PF; Griffin, MR; Simberkoff, MS; Yeh, SS; Lobo, Z; Holodniy, M; Loutit, J; Betts, RF; Gelb, LD; Crawford, GE; Guatelli, J; Brooks, PA; Looney, DJ; Neuzil, KM; Toney, JF; Kauffman, CA; Keay, SK; Marques, AR; Pachucki, CT; Levin, MJ; Schmader, KE; Morrison, VA; Wright, PF; Griffin, MR; Betts, RF; Gelb, LD; Guatelli, JC; Looney, DJ; Neuzil, KM; Menzies, B; Toney, JF

2015-01-01

Background. The Shingles Prevention Study (SPS) demonstrated zoster vaccine efficacy through 4 years postvaccination. A Short-Term Persistence Substudy (STPS) demonstrated persistence of vaccine efficacy for at least 5 years. A Long-Term Persistence Substudy (LTPS) was undertaken to further assess vaccine efficacy in SPS vaccine recipients followed for up to 11 years postvaccination. Study outcomes were assessed for the entire LTPS period and for each year from 7 to 11 years postvaccination. Methods. Surveillance, case determination, and follow-up were comparable to those in SPS and STPS. Because SPS placebo recipients were offered zoster vaccine before the LTPS began, there were no unvaccinated controls. Instead, SPS and STPS placebo results were used to model reference placebo groups. Results. The LTPS enrolled 6867 SPS vaccine recipients. Compared to SPS, estimated vaccine efficacy in LTPS decreased from 61.1% to 37.3% for the herpes zoster (HZ) burden of illness (BOI), from 66.5% to 35.4% for incidence of postherpetic neuralgia, and from 51.3% to 21.1% for incidence of HZ, and declined for all 3 outcome measures from 7 through 11 years postvaccination. Vaccine efficacy for the HZ BOI was significantly greater than zero through year 10 postvaccination, whereas vaccine efficacy for incidence of HZ was significantly greater than zero only through year 8. Conclusions. Estimates of vaccine efficacy decreased over time in the LTPS population compared with modeled control estimates. Statistically significant vaccine efficacy for HZ BOI persisted into year 10 postvaccination, whereas statistically significant vaccine efficacy for incidence of HZ persisted only through year 8. PMID:25416754

Atomoxetine and Methylphenidate Treatment in Children with ADHD: The Efficacy, Tolerability and Effects on Executive Functions

ERIC Educational Resources Information Center

Yildiz, Ozlem; Sismanlar, Sahika G.; Memik, Nursu Cakin; Karakaya, Isik; Agaoglu, Belma

2011-01-01

The aim of this study was to compare the safety, efficacy, tolerability, and the effects of atomoxetine and OROS-MPH on executive functions in children with ADHD. This study was an open-label study that only included two medication groups. Children were randomized to open-label atomoxetine or OROS-MPH for 12 weeks. Primary efficacy measures were…

Effectiveness versus efficacy trials in COPD: how study design influences outcomes and applicability.

PubMed

Woodcock, Ashley; Boucot, Isabelle; Leather, David A; Crawford, Jodie; Collier, Susan; Bakerly, Nawar Diar; Hilton, Emma; Vestbo, Jørgen

2018-02-01

Guidelines for chronic obstructive pulmonary disease (COPD) management are based largely on results from double-blind randomised controlled trials (RCTs) of efficacy. These trials have high internal validity and test whether a drug is efficacious, but they are conducted in highly selected populations that may differ significantly from patients with COPD seen in routine practice.We compared the baseline characteristics, healthcare use and outcomes between the Salford Lung Study (SLS), an open-label effectiveness RCT, with six recent large-scale efficacy RCTs. We also calculated the proportion of SLS patients who would have been eligible for inclusion in an efficacy RCT by applying the inclusion criteria used in efficacy trials of combination treatments.SLS patients were older, included more females and more current smokers, had more comorbidities (including asthma), and had more often experienced exacerbations prior to inclusion. In the SLS, rates of moderate or severe exacerbations, incidence of overall serious adverse events (SAEs), and SAEs of pneumonia were more frequent. A maximum of 30% of patients enrolled in the SLS would have been eligible for a phase IIIa regulatory exacerbation study.Patients in large COPD efficacy RCTs have limited representativeness compared with an effectiveness trial. This should be considered when interpreting efficacy RCT outcomes and their inclusion into guidelines. Copyright ©ERS 2018.

Planning a Stigmatized Nonvisible Illness Disclosure: Applying the Disclosure Decision-Making Model

PubMed Central

Choi, Soe Yoon; Venetis, Maria K.; Greene, Kathryn; Magsamen-Conrad, Kate; Checton, Maria G.; Banerjee, Smita C.

2016-01-01

This study applied the disclosure decision-making model (DD-MM) to explore how individuals plan to disclose nonvisible illness (Study 1), compared to planning to disclose personal information (Study 2). Study 1 showed that perceived stigma from the illness negatively predicted disclosure efficacy; closeness predicted anticipated response (i.e., provision of support) although it did not influence disclosure efficacy; disclosure efficacy led to reduced planning, with planning leading to scheduling. Study 2 demonstrated that when information was considered to be intimate, it negatively influenced disclosure efficacy. Unlike the model with stigma (Study 1), closeness positively predicted both anticipated response and disclosure efficacy. The rest of the hypothesized relationships showed a similar pattern to Study 1: disclosure efficacy reduced planning, which then positively influenced scheduling. Implications of understanding stages of planning for stigmatized information are discussed. PMID:27662447

Planning a Stigmatized Nonvisible Illness Disclosure: Applying the Disclosure Decision-Making Model.

PubMed

Choi, Soe Yoon; Venetis, Maria K; Greene, Kathryn; Magsamen-Conrad, Kate; Checton, Maria G; Banerjee, Smita C

2016-11-16

This study applied the disclosure decision-making model (DD-MM) to explore how individuals plan to disclose nonvisible illness (Study 1), compared to planning to disclose personal information (Study 2). Study 1 showed that perceived stigma from the illness negatively predicted disclosure efficacy; closeness predicted anticipated response (i.e., provision of support) although it did not influence disclosure efficacy; disclosure efficacy led to reduced planning, with planning leading to scheduling. Study 2 demonstrated that when information was considered to be intimate, it negatively influenced disclosure efficacy. Unlike the model with stigma (Study 1), closeness positively predicted both anticipated response and disclosure efficacy. The rest of the hypothesized relationships showed a similar pattern to Study 1: disclosure efficacy reduced planning, which then positively influenced scheduling. Implications of understanding stages of planning for stigmatized information are discussed.

Comparison of Self-Efficacy for Managing Chronic Disease between patients with systemic sclerosis and other chronic conditions: a systematic review.

PubMed

Thombs, Brett D; Kwakkenbos, Linda; Riehm, Kira E; Saadat, Nazanin; Fedoruk, Claire

2017-02-01

The complexity and burden of systemic sclerosis (SSc) pose challenges to developing and sustaining disease management self-efficacy. The objective of this systematic review was to compare scores on a commonly used self-efficacy measure, the Self-Efficacy for Managing Chronic Disease (SEMCD) Scale, between SSc and other diseases. Data sources included the CINAHL, EMBASE, MEDLINE, and Scopus databases, searched through January 25, 2016, and reference lists of included articles and relevant reviews. Studies in any language that reported total SEMCD scores or individual item scores in adult non-psychiatric medical patients were eligible. We identified one eligible non-intervention study of SSc patients (n = 553), 13 other non-intervention studies, and 21 studies with pre-intervention data for patients enrolled in a self-management program or a trial of a program. Of 13 non-intervention studies with published total score means in cancer, cardiovascular disease, Parkinson's disease, spinal cord injuries, organ transplant candidates and recipients, dialysis, and lupus, SEMCD scores were statistically significantly lower (poorer self-efficacy) in SSc than 6 other disease samples, not significantly different from 6, and significantly higher than lupus patients. Compared to 18 studies of patients in self-management programs or trials with published total score means, SSc patients were similar or lower than 9 samples and significantly higher than 9 samples. Compared to patients with other diseases not enrolled in programs to improve self-efficacy, SSc patients report lower self-efficacy scores than most patient groups. Rigorously tested self-care interventions designed to meet the unique needs of patients with SSc are needed.

Comparative efficacy of tulathromycin versus florfenicol and tilmicosin against undifferentiated bovine respiratory disease in feedlot cattle.

PubMed

Skogerboe, Terry L; Rooney, Kathleen A; Nutsch, Robert G; Weigel, Daniel J; Gajewski, Kimberly; Kilgore, W Randal

2005-01-01

Four studies conducted at feedlots in Greeley and Wellington, Colorado; Nebraska; and Texas compared the efficacy of tulathromycin to florfenicol or tilmicosin for the treatment of cattle with undifferentiated bovine respiratory disease (BRD) and subsequent feedlot performance and carcass characteristics. In each study, 100 calves with BRD were treated with tulathromycin given SC at 2.5 mg/kg body weight. At the Greeley, CO, and Nebraska study locations, 100 calves were treated with florfenicol given SC at 40 mg/kg body weight, and at the Wellington, CO, and Texas study locations, tilmicosin was given SC at 10 mg/kg body weight. Cure rate, a derived variable that included assessments of mortality, rectal temperature, and attitude and respiratory scores from day 3 to day 28 and day 3 through harvest, was the primary assessment of BRD efficacy. Cure rates of calves treated with tulathromycin were significantly (P < or = .009) higher than those calves treated with florfenicol. At Wellington, CO, the cure rate of calves treated with tulathromycin was significantly higher (P < or = .018) compared with tilmicosin-treated calves. The differences in cure rates between tulathromycin and tilmicosin treatment groups in the Texas study were not significantly different (P > .05). Tulathromycin was more efficacious in the treatment of undifferentiated BRD compared with florfenicol and, in one study, compared with tilmicosin.

The effects of antenatal education on fear of childbirth, maternal self-efficacy and post-traumatic stress disorder (PTSD) symptoms following childbirth: an experimental study.

PubMed

Gökçe İsbir, Gözde; İnci, Figen; Önal, Hatice; Yıldız, Pelin Dıkmen

2016-11-01

Fear of birth and low childbirth self-efficacy is predictive of post-traumatic stress disorder symptoms following childbirth. The efficacy of antenatal education classes on fear of birth and childbirth self-efficacy has been supported; however, the effectiveness of antenatal classes on post-traumatic stress disorder symptoms after childbirth has received relatively little research attention. This study examined the effects of antenatal education on fear of childbirth, maternal self-efficacy and post-traumatic stress disorder symptoms following childbirth. Quasi-experimental study. The study was conducted in a city located in the Middle Anatolia region of Turkey and data were collected between December 2013 and May 2015. Two groups of women were compared-an antenatal education intervention group (n=44), and a routine prenatal care control group (n=46). The Wijma Delivery Expectancy/Experience Questionnaire, Version A and B, Childbirth Self-efficacy Inventory and Impact of Event Scale-Revised was used to assess fear of childbirth, maternal self-efficacy and PTSD symptoms following childbirth. Compared to the control group, women who attended antenatal education had greater childbirth self-efficacy, greater perceived support and control in birth, and less fear of birth and post-traumatic stress disorder symptoms following childbirth (all comparisons, p<0.05). Antenatal education appears to alleviate post-traumatic stress disorder symptoms after childbirth. Copyright © 2016 Elsevier Inc. All rights reserved.

Prematurity and parental self-efficacy: the Preterm Parenting & Self-Efficacy Checklist.

PubMed

Pennell, Claire; Whittingham, Koa; Boyd, Roslyn; Sanders, Matthew; Colditz, Paul

2012-12-01

There is a lack of research investigating parental self-efficacy in parents of infants born preterm as well as a paucity of parental self-efficacy measures that are domain-specific and theoretically grounded. This study aimed to compare parental self-efficacy in parents of infants born term, preterm and very preterm as well as to test whether parental self-efficacy mediates the relationship between psychological symptoms and parental competence. In order to achieve this, a new measure of parental self-efficacy and parental competence relevant for the preterm population and consistent with Bandura's (1977, 1986, 1989) conceptualisation of self-efficacy was developed. Participants included 155 parents, 83 of whom were parents of very preterm (GA<32 weeks), 40 parents of preterm (GA<37 weeks) and 32 parents of term born infants. Parents completed the Preterm Parenting & Self-Efficacy Checklist (the new measure), Family Demographic Questionnaire, Depression Anxiety Stress Scale and Self-Efficacy Questionnaire. This initial study indicates that the Preterm Parenting & Self-Efficacy Checklist has adequate content validity, construct validity, internal consistency and split half reliability. Contrary to expectations, parents of very preterm infants did not report significantly lower overall levels of parental self-efficacy or significantly higher levels of psychological symptoms compared to parents of preterm and term infants. Parental self-efficacy about parenting tasks mediated the relationship between psychological symptoms and self perceived parental competence as predicted. Clinical implications of the results and suggestions for future research are discussed. Crown Copyright © 2012. Published by Elsevier Inc. All rights reserved.

Comparison of African American and Caucasian Caregiver Self-Efficacy.

PubMed

Easom, Leisa; Cotter, Ellen; Ramos, Angel

2018-03-01

Self-efficacy influences one's behavior and can determine the degree to which one is motivated to take action. The current study explores changes in caregiver self-efficacy pre- and post-participation in a Resources for Enhancing Alzheimer's Caregiver Health (REACH II) program, a multi-component intervention aimed at caregivers of individuals with Alzheimer's disease. The study specifically compared this construct in African American and Caucasian populations, which may give indications of how to empower dementia caregivers and whether REACH II is culturally sensitive and thus, an important component to examine. Nurses are the connection between families and community resources and must serve as referral sources to programs that work. Although African American and Caucasian caregivers showed comparable rates of increase in self-efficacy, African American caregivers started and ended at higher rates of self-efficacy for obtaining respite and overall self-efficacy. Applications of the results and directions for future research are discussed. [Journal of Gerontological Nursing, 44(3), 16-21.]. Copyright 2018, SLACK Incorporated.

A systematic review of dermal fillers for age-related lines and wrinkles.

PubMed

Sturm, Lana P; Cooter, Rodney D; Mutimer, Keith L; Graham, John C; Maddern, Guy J

2011-01-01

Dermal fillers are gaining popularity for rapid aesthetic improvement. Long-term efficacy and safety have not been well documented. The aim of this systematic review was to assess the safety and efficacy of injectable dermal fillers compared with other facial augmentation techniques for the management of age-related lines and wrinkles. Studies including patients receiving injectable semi-permanent or permanent dermal fillers for age-related lines and wrinkles were included in this review. Efficacy outcomes (including changes in skin thickness and patient satisfaction) and safety outcomes (including mortality, lumps and infections) were examined. Three randomized control trials and six case series were included. Permanent and semi-permanent dermal fillers improved subjective ratings of appearance and resulted in higher patient satisfaction than temporary fillers. Long-term efficacy appeared good in the few studies that reported it. Short-term safety appeared favourable. Lumps were reported in all but one study but received little follow-up. Long-term safety data were limited. The treatment of age-related lines and wrinkles with permanent and semi-permanent dermal fillers is more efficacious compared with temporary fillers in those studies that compared them. Case series evidence suggests that these fillers achieve their objective, which is to decrease the visible effects of age-related changes. These fillers appear at least as safe as temporary fillers in the short term in those studies that compared them. Long-term safety could not be determined. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

Hyperhidrosis: Anatomy, Pathophysiology and Treatment with Emphasis on the Role of Botulinum Toxins

PubMed Central

Lakraj, Amanda-Amrita D.; Moghimi, Narges; Jabbari, Bahman

2013-01-01

Clinical features, anatomy and physiology of hyperhidrosis are presented with a review of the world literature on treatment. Level of drug efficacy is defined according to the guidelines of the American Academy of Neurology. Topical agents (glycopyrrolate and methylsulfate) are evidence level B (probably effective). Oral agents (oxybutynin and methantheline bromide) are also level B. In a total of 831 patients, 1 class I and 2 class II blinded studies showed level B efficacy of OnabotulinumtoxinA (A/Ona), while 1 class I and 1 class II study also demonstrated level B efficacy of AbobotulinumtoxinA (A/Abo) in axillary hyperhidrosis (AH), collectively depicting Level A evidence (established) for botulinumtoxinA (BoNT-A). In a comparator study, A/Ona and A/Inco toxins demonstrated comparable efficacy in AH. For IncobotulinumtoxinA (A/Inco) no placebo controlled studies exist; thus, efficacy is Level C (possibly effective) based solely on the aforementioned class II comparator study. For RimabotulinumtoxinB (B/Rima), one class III study has suggested Level U efficacy (insufficient data). In palmar hyperhidrosis (PH), there are 3 class II studies for A/Ona and 2 for A/Abo (individually and collectively level B for BoNT-A) and no blinded study for A/Inco (level U). For B/Rima the level of evidence is C (possibly effective) based on 1 class II study. Botulinum toxins (BoNT) provide a long lasting effect of 3–9 months after one injection session. Studies on BoNT-A iontophoresis are emerging (2 class II studies; level B); however, data on duration and frequency of application is inconsistent. PMID:23612753

Effects of Social Persuasion from Parents and Teachers on Chinese Students' Self-Efficacy: An Exploratory Study

ERIC Educational Resources Information Center

Lam, Yuen Yi; Chan, Joanne Chung Yan

2017-01-01

This study compared the effects of social persuasion from parents and teachers on students' self-efficacy in reading comprehension in English as a foreign language. Ninety-nine Grade 8 Chinese students in a secondary school in Hong Kong completed a questionnaire with six scenarios which tapped their self-efficacy after receiving positive and…

A Cross-Cultural Comparison of Singaporean and Taiwanese Eighth Graders' Science Learning Self-Efficacy from a Multi-Dimensional Perspective

ERIC Educational Resources Information Center

Lin, Tzung-Jin; Tan, Aik Ling; Tsai, Chin-Chung

2013-01-01

Due to the scarcity of cross-cultural comparative studies in exploring students' self-efficacy in science learning, this study attempted to develop a multi-dimensional science learning self-efficacy (SLSE) instrument to measure 316 Singaporean and 303 Taiwanese eighth graders' SLSE and further to examine the differences between the two student…

Anti-Cancer Efficacy of Silybin Derivatives - A Structure-Activity Relationship

PubMed Central

Agarwal, Chapla; Wadhwa, Ritambhara; Deep, Gagan; Biedermann, David; Gažák, Radek; Křen, Vladimír; Agarwal, Rajesh

2013-01-01

Silybin or silibinin, a flavonolignan isolated from Milk thistle seeds, is one of the popular dietary supplements and has been extensively studied for its antioxidant, hepatoprotective and anti-cancer properties. We have envisioned that potency of silybin could be further enhanced through suitable modification/s in its chemical structure. Accordingly, here, we synthesized and characterized a series of silybin derivatives namely 2,3-dehydrosilybin (DHS), 7-O-methylsilybin (7OM), 7-O-galloylsilybin (7OG), 7,23-disulphatesilybin (DSS), 7-O-palmitoylsilybin (7OP), and 23-O-palmitoylsilybin (23OP); and compared their anti-cancer efficacy using human bladder cancer HTB9, colon cancer HCT116 and prostate carcinoma PC3 cells. In all the 3 cell lines, DHS, 7OM and 7OG demonstrated better growth inhibitory effects and compared to silybin, while other silybin derivatives showed lesser or no efficacy. Next, we prepared the optical isomers (A and B) of silybin, DHS, 7OM and 7OG, and compared their anti-cancer efficacy. Isomers of these three silybin derivatives also showed better efficacy compared with respective silybin isomers, but in each, there was no clear cut silybin A versus B isomer activity preference. Further studies in HTB cells found that DHS, 7OM and 7OG exert better apoptotic activity than silibinin. Clonogenic assays in HTB9 cells further confirmed that both the racemic mixtures as well as pure optical isomers of DHS, 7OM and 7OG were more effective than silybin. Overall, these results clearly suggest that the anti-cancer efficacy of silybin could be significantly enhanced through structural modifications, and identify strong anti-cancer efficacy of silybin derivatives, namely DHS, 7OM, and 7OG, signifying that their efficacy and toxicity should be evaluated in relevant pre-clinical cancer models in rodents. PMID:23555889

Efficacy and safety profile of xanthines in COPD: a network meta-analysis.

PubMed

Cazzola, Mario; Calzetta, Luigino; Barnes, Peter J; Criner, Gerard J; Martinez, Fernando J; Papi, Alberto; Gabriella Matera, Maria

2018-06-30

Theophylline can still have a role in the management of stable chronic obstructive pulmonary disease (COPD), but its use remains controversial, mainly due to its narrow therapeutic window. Doxofylline, another xanthine, is an effective bronchodilator and displays a better safety profile than theophylline. Therefore, we performed a quantitative synthesis to compare the efficacy and safety profile of different xanthines in COPD.The primary end-point of this meta-analysis was the impact of xanthines on lung function. In addition, we assessed the risk of adverse events by normalising data on safety as a function of person-weeks. Data obtained from 998 COPD patients were selected from 14 studies and meta-analysed using a network approach.The combined surface under the cumulative ranking curve (SUCRA) analysis of efficacy (change from baseline in forced expiratory volume in 1 s) and safety (risk of adverse events) showed that doxofylline was superior to aminophylline (comparable efficacy and significantly better safety), bamiphylline (significantly better efficacy and comparable safety), and theophylline (comparable efficacy and significantly better safety).Considering the overall efficacy/safety profile of the investigated agents, the results of this quantitative synthesis suggest that doxofylline seems to be the best xanthine for the treatment of COPD. Copyright ©ERS 2018.

Interdependent Self-Construal, Self-Efficacy, and Community Involvement as Predictors of Perceived Knowledge Gain Among MMORPG Players.

PubMed

Hopp, Toby; Barker, Valerie; Schmitz Weiss, Amy

2015-08-01

This study explored the relationship between interdependent self-construal, video game self-efficacy, massively multiplayer online role-playing game (MMORPG) community involvement, and self-reported learning outcomes. The results suggested that self-efficacy and interdependent self-construal were positive and significant predictors of MMORPG community involvement. For its part, MMORPG community involvement was a positive predictor of self-reported learning in both focused and incidental forms. Supplementary analyses suggested that self-efficacy was a comparatively more robust predictor of MMORPG community involvement when compared to self-construal. Moreover, the present data suggest that community involvement significantly facilitated indirect relationships between self-construal, game-relevant self-efficacy, and both focused and incidental learning.

Efficacy of exposure versus cognitive therapy in anxiety disorders: systematic review and meta-analysis

PubMed Central

2011-01-01

Background There is growing evidence of the effectiveness of Cognitive Behavioural Therapy (CBT) for a wide range of psychological disorders. There is a continued controversy about whether challenging maladaptive thoughts rather than use of behavioural interventions alone is associated with the greatest efficacy. However little is known about the relative efficacy of various components of CBT. This review aims to compare the relative efficacy of Cognitive Therapy (CT) versus Exposure (E) for a range of anxiety disorders using the most clinically relevant outcome measures and estimating the summary relative efficacy by combining the studies in a meta-analysis. Methods Psych INFO, MEDLINE and EMBASE were searched from the first available year to May 2010. All randomised controlled studies comparing the efficacy of exposure with cognitive therapy were included. Odds ratios (OR) or standardised means' differences (Hedges' g) for the most clinically relevant primary outcomes were calculated. Outcomes of the studies were grouped according to specific disorders and were combined in meta-analyses exploring short-term and long-term outcomes. Results 20 Randomised Controlled Trials with (n = 1,308) directly comparing the efficacy of CT and E in anxiety disorders were included in the meta-analysis. No statistically significant difference in the relative efficacy of CT and E was revealed in Post Traumatic Stress Disorder (PTSD), in Obsessive Compulsive Disorder (OCD) and in Panic Disorder (PD). There was a statistically significant difference favouring CT versus E in Social Phobia both in the short-term (Z = 3.72, p = 0.0002) and the long-term (Z = 3.28, p = 0.001) outcomes. Conclusions On the basis of extant literature, there appears to be no evidence of differential efficacy between cognitive therapy and exposure in PD, PTSD and OCD and strong evidence of superior efficacy of cognitive therapy in social phobia PMID:22185596

TPACK Competencies and Technology Integration Self-Efficacy Perceptions of Pre-Service Teachers

ERIC Educational Resources Information Center

Keser, Hafize; Karaoglan Yilmaz, Fatma Gizem; Yilmaz, Ramazan

2015-01-01

This study compared the technological pedagogical content knowledge (TPACK) competency of pre-service teachers with their self-efficacy perception towards technology integration, based on various variables; and the correlation between their TPACK competencies and self-efficacy perceptions towards technology integration were examined. The study…

Replacing Relative Reinforcing Efficacy with Behavioral Economic Demand Curves

ERIC Educational Resources Information Center

Johnson, Matthew W.; Bickel, Warren K.

2006-01-01

Relative reinforcing efficacy refers to the behavior-strengthening or maintaining property of a reinforcer when compared to that of another reinforcer. Traditional measures of relative reinforcing efficacy sometimes have led to discordant results across and within studies. By contrast, previous investigations have found traditional measures to be…

Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy.

PubMed

Koren, Gideon; Clark, Shannon; Hankins, Gary D V; Caritis, Steve N; Umans, Jason G; Miodovnik, Menachem; Mattison, Donald R; Matok, Ilan

2016-11-24

Nausea and vomiting of pregnancy (NVP) affects up to 80% of expecting mothers. In April 2013 the FDA approved the delayed-release combination of doxylamine succinate and pyridoxine hydrochloride (Diclegis®) for NVP, based in part, on the results of a phase III randomized trial demonstrating the efficacy of this drug combination [study drug marketed under the trade name Diclectin® in Canada and Diclegis® in the United States] compared to placebo in pregnant women. Study drug dosing occurred for 14 days, which is substantially longer than what has been performed in similar studies. The objective of this study was to evaluate, through secondary analysis, whether the primary measure of efficacy can be demonstrated after five days of treatment. Women suffering from NVP were randomized to receive Diclegis® (n = 131) or placebo (n = 125) for 14 days at doses ranging from two to four tablets a day, based on a pre-specified titration protocol. The primary efficacy endpoint was the change in the validated Pregnancy-Unique Quantification of Emesis (PUQE) score at baseline versus Day 15 between Diclegis®-treated and placebo-treated women. For the present study, the change in PUQE score between baseline and Day 15 (end of the study) was compared to the changes observed for Days 3, 4, and 5. The use of delayed-release doxylamine succinate and pyridoxine hydrochloride tablets show improved NVP symptom control as compared to placebo on Days 3,4 and 5, with sustained efficacy until the end of the trial. A four day study drug dosing trial with Diclegis® is sufficient to document efficacy, as the results are similar to those achieved after 14 study drug dosing days. The benefit seen at the earlier time validates drug efficacy and minimizes the natural course of improvement. CTR No. NCT006 14445 2007.

Comparative In Vitro Efficacy of Doripenem and Imipenem Against Multi-Drug Resistant Pseudomonas aeruginosa.

PubMed

Wali, Nadia; Mirza, Irfan Ali

2016-04-01

To compare the in vitro efficacy of doripenem and imipenem against multi-drug resistant (MDR) Pseudomonas aeruginosa from various clinical specimens. Descriptive cross-sectional study. Department of Microbiology, Armed Forces Institute of Pathology, Rawalpindi, from November 2012 to November 2013. MDR Pseudomonas aeruginosa isolates from various clinical samples were included in the study. Susceptibility of Pseudomonas aeruginosa against doripenem and imipenem was performed by E-test strip and agar dilution methods. The results were interpreted as recommended by Clinical Laboratory Standard Institute (CLSI) guidelines. The maximum number of Pseudomonas aeruginosa were isolated from pure pus and pus swabs. In vitro efficacy of doripenem was found to be more effective as compared to imipenem against MDR Pseudomonas aeruginosa with both E-test strip and agar dilution methods. Overall, p-values of 0.014 and 0.037 were observed when susceptibility patterns of doripenem and imipenem were evaluated with E-test strip and agar dilution methods. In vitro efficacy of doripenem was found to be better against MDR Pseudomonas aeruginosaas compared to imipenem when tested by both E-test and agar dilution methods.

Efficacy and safety of statins and exercise combination therapy compared to statin monotherapy in patients with dyslipidaemia: A systematic review and meta-analysis.

PubMed

Gui, Ya-Jun; Liao, Cai-Xiu; Liu, Qiong; Guo, Yuan; Yang, Tao; Chen, Jing-Yuan; Wang, Ya-Ting; Hu, Jia-Hui; Xu, Dan-Yan

2017-06-01

Background Statin treatment in association with physical exercise can substantially reduce mortality in dyslipidaemic individuals. However, the available data to compare the efficacy and safety of statins and exercise combination therapy with statin monotherapy are limited. Design Systematic review and meta-analysis. Methods We systematically searched PubMed, Embase and the Cochrane Library from database inception until December 2016. We included randomised and non-randomised studies that compared the efficacy and safety of statins and exercise combination therapy with statin monotherapy in patients with dyslipidaemia. Standardised mean differences were calculated and pooled by means of fixed effects models. The risk of bias and heterogeneity among trials was also assessed. Seven articles were assessed in terms of the efficacy of therapy and 13 from the viewpoint of therapeutic safety. Results In terms of efficacy, statins and exercise combination decreased the incidence of diabetes mellitus, improved insulin sensitivity and inflammation, but caused no change in lipid profile compared to statins alone. In terms of safety, statins and exercise combination increased peak oxygen uptake (standardised mean difference 1.01, 95% confidence interval 0.46 to 1.57) compared to statins alone. In contrast to statin-induced myopathy, chronic exercise training prior to statin treatment could counteract statin-induced adverse effects in skeletal muscle. Conclusion Statins and exercise combination therapy is more effective than statin monotherapy in terms of insulin sensitivity, inflammation and exercise capacity. The small number of studies warrants the need for more randomised controlled trials evaluating the efficacy and safety of combination therapy.

[Meta-analysis of needle-knife treatment on cervical spondylosis].

PubMed

Kan, Li-Li; Wang, Hai-Dong; Liu, An-Guo

2013-11-01

To assess the efficacy of cervical spondylosis by needle-knife treatment according to the correlated literature of RCT,to compare advantages of needle-knife treatment. Randomized Controlled Trials about needle-knife treatment of cervical spondylosis were indexed from Chinese HowNet (CNKI) and Wanfang (WF) from 2000 to 2012, then were analyzed the efficacy by Review Manager 5.1 software. A total of 13 RCT literatures and 1 419 patients were included. The methods of included studies were poor in quality evaluation because of large sample and multi-center RCT studies was lacked, randomization method was not accurate enough, diagnostic criteria and efficacy evaluation were various, only four studies described long-term efficacy, most of the literature didn't describe the adverse event and fall off,all studies did not use the blind method. The Meta analysis outcome showed overall efficiency of needle-knife therapy was better than acupuncture and traction. Needle-knife therapy compared with Acupuncture, the total RR = 0.19, 95% confidence interval was (0.15, 0.24), P < 0.000.01. Compared with traction therapy the total RR = 1.30, 95% confidence intervalwas (1.18,1.42), P < 0.00001. Compared with acupuncture therapy,the overall effectiveness of needle-knife therapy is higher;compared with traction therapy, although,needle-knife therapy has a high overall effectiveness, but because of the loss of total sample size, the outcome RCT researches to confirm.

Effectiveness of simulation for improvement in self-efficacy among novice nurses: a meta-analysis.

PubMed

Franklin, Ashley E; Lee, Christopher S

2014-11-01

The influence of simulation on self-efficacy for novice nurses has been reported inconsistently in the literature. Effect sizes across studies were synthesized using random-effects meta-analyses. Simulation improved self-efficacy in one-group, pretest-posttest studies (Hedge's g=1.21, 95% CI [0.63, 1.78]; p<0.001). Simulation also was favored over control teaching interventions in improving self-efficacy in studies with experimental designs (Hedge's g=0.27, 95% CI [0.1, 0.44]; p=0.002). In nonexperimental designs, consistent conclusions about the influence of simulation were tempered by significant between-study differences in effects. Simulation is effective at increasing self-efficacy among novice nurses, compared with traditional control groups. Copyright 2014, SLACK Incorporated.

Effects of the weight management program based self-efficacy for body composition, blood lipid profile, weight self-efficacy lifestyles, depression in middle-aged obese women.

PubMed

Park, Nam Hee; An, Hye Gyung

2006-12-01

This study was done to determine the effects of weight management program using self-efficacy in middle-aged obese women. The study also attempted to measure the effects of the program on the weight efficacy lifestyle, body composition, and depression. The research design of this study was a nonequivalent control group pretest-posttest design. The experimental group consisted of 21 middle-aged obese women and another 21 middle-aged obese women in the control group. The women in the experimental group participated in the weight management program for 12 weeks using self-efficacy. The weight management program using self-efficacy included education on effects of exercise for weight control, aerobic exercise program, muscle training and counseling through the telephone. After 12 weeks of participation in the program, BMI (p<.0001), body fat % (p<.0001), abdominal fat (p<.0001), in the experimental group were significantly decreased compared to the control group. Weight self-efficacy lifestyle (p<.0001) and depression (p=.006) in the experimental group were significantly improved after the program compared to the control group. According to these findings, weight management program self-efficacy for middle-aged obese women could increase weight efficacy lifestyle, and decrease depression, BMI, body fat, and abdominal fat. The result also suggested that the increasing weight efficacy and lifestyle help the obese women to perform and continue exercise. This program could be used in the community such as public health center for weight care and mental health promotion of middle-aged obese women.

Math and Science Pursuits: A Self-Efficacy Intervention Comparison Study

ERIC Educational Resources Information Center

Cordero, Elizabeth D.; Porter, Sarah H.; Israel, Tania; Brown, Michael T.

2010-01-01

This study compared two interventions to increase math self-efficacy among undergraduate students. Ninety-nine first-year undergraduate students participated in an intervention involving performance accomplishment or an intervention combining performance accomplishment and belief-perseverance techniques in which participants constructed a…

Rural High School Teachers' Self-Efficacy in Student Engagement, Instructional Strategies, and Classroom Management

ERIC Educational Resources Information Center

Shoulders, Tori L.; Krei, Melinda Scott

2015-01-01

The purpose of this study was to compare the differences in rural high school teachers' (n = 256) self-efficacy in student engagement, instructional practices, and classroom management using selected teacher characteristics. Analysis of variance showed significant mean differences between different levels of education in self-efficacy for…

The Self-Efficacy of Preservice Elementary Teachers in Kuwaiti Science Programs

ERIC Educational Resources Information Center

Ebrahim, Ali H.

2012-01-01

This study examined educational factors that positively influenced the confidence of students training to be elementary science educators (self efficacy). Specifically, it compared the impacts of a science method course and a practicum teaching course on Kuwait University students. Using a pre/post design, The Science Teaching Efficacy Belief…

Comparative Analysis of Expectancies of Efficacy in In-Service and Prospective Teachers

ERIC Educational Resources Information Center

de la Torre Cruz, Manuel J.; Casanova Arias, Pedro F.

2007-01-01

This study examines the beliefs about effective teaching in student teachers and inservice teachers. We constructed a measurement composed of an adaptation in Spanish of the Gibson and Dembo's (1984. Teacher efficacy: A construct validation. "Journal of Educational Psychology", 76, 569-582). Teacher Efficacy Scale and of the items…

A Comparative Study on the Teaching Profession in Turkey and South Korea: Secondary Analysis of TALIS 2008 Data in Relation to Teacher Self-Efficacy

ERIC Educational Resources Information Center

Aslan, Berna

2015-01-01

Problem Statement: Teacher self-efficacy is important factor for school and student success. This study investigates the variables that explain teacher self-efficacy in Turkey and South Korea according to TALIS 2008 data. A detailed comparison was conducted and the state of the teaching profession in both countries is discussed. Purpose of the…

Liposomal-benzocaine gel formulation: correlation between in vitro assays and in vivo topical anesthesia in volunteers.

PubMed

Franz-Montan, Michelle; Cereda, Cintia Maria Saia; Gaspari, Adele; da Silva, Camila Morais Gonçalves; de Araújo, Daniele Ribeiro; Padula, Cristina; Santi, Patrizia; Narvaes, Eliene; Novaes, Pedro Duarte; Groppo, Francisco Carlos; de Paula, Eneida

2013-03-01

The aim of the present study was to characterize a liposome-based benzocaine (BZC) formulation designed for topical use on the oral mucosa and to evaluate its in vitro retention and permeation using the Franz-type diffusion cells through pig esophagus mucosa. To predict the effectiveness of new designed formulations during preclinical studies, a correlation between in vitro assays and in vivo efficacy was performed. Liposomal BZC was characterized in terms of membrane/water partition coefficient, encapsulation efficiency, size, polydispersity, zeta potential, and morphology. Liposomal BZC (BL10) was incorporated into gel formulation and its performances were compared to plain BZC gel (B10) and the commercially available BZC gel (B20). BL10 and B10 presented higher flux and retention on pig esophagus mucosa with a shorter lag time, when compared to B20. BZC flux was strongly correlated with in vivo anesthetic efficacy, but not with topical anesthesia duration. The retention studies did not correlate with any of the in vivo efficacy parameters. Thus, in vitro permeation study can be useful to predict anesthetic efficacy during preclinical tests, because a correlation between flux and anesthetic efficacy was observed. Therefore, in vitro assays, followed by in vivo efficacy, are necessary to confirm anesthetic performance.

The efficacy of methylene blue encapsulated in silica nanoparticles compared to naked methylene blue for photodynamic applications.

PubMed

Makhadmeh, Ghaseb Naser; Abdul Aziz, Azlan; Abdul Razak, Khairunisak

2016-05-01

This study analyzed the physical effects of methylene blue (MB) encapsulated within silica nanoparticles (SiNPs) in photodynamic therapy. The optimum concentration of MB needed to destroy red blood cells (RBCs) was determined, and the efficacy of encapsulated MB-SiNPs compared to that of naked MB was verified. The results confirmed the applicability of MB encapsulated in SiNPs on RBCs, and established a relationship between the concentration of the SiNP-encapsulated MB and the time required to rupture 50% of the RBCs (t50). The MB encapsulated in SiNPs exhibited higher efficacy compared to that of naked MB.

Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids.

PubMed

Seitz, Christian; Bumbuliene, Žana; Costa, Ana Rosa; Heikinheimo, Oskari; Heweker, Andrea; Hudeček, Robert; Jacquemyn, Yves; Melis, Gian Benedetto; Parashar, Pooja; Rechberger, Tomasz; Sánchez, Antonio Cano; van Aken, Bart; Zatik, János; Gemzell-Danielsson, Kristina

2017-04-01

Uterine fibroids (UFs) may be treated with progesterone receptor modulators (PRMs), which have been shown to reduce heavy menstrual bleeding and the size of UFs. To date, one PRM (ulipristal acetate) has received regulatory approval for the treatment of UFs; therapy comprises intermittent treatment courses of up to 3months each, followed by a break to allow two menstruations to occur. We report the design of ASTEROID (Assess Safety and efficacy of vilaprisan in patients with uTERine fibrOIDs) 2, a phase 2 study examining the efficacy and safety of a novel PRM, vilaprisan, in women with UFs. In this randomized multi-arm study, vilaprisan (2mg daily) will be administered in different regimens: continuous treatment for 12 or 24weeks, or two 12-week treatment periods separated by a break to allow one menstruation to occur. Efficacy and safety will be compared with that of ulipristal acetate (5mg daily) and placebo. Patients randomized to receive placebo for 12weeks will also be given active treatment for 12weeks. The primary measure of efficacy will be amenorrhoea rate; secondary measures include time to normalized menstrual bleeding and percentage change in UF volume. Endometrial changes will be monitored throughout the study. The placebo- and active comparator-controlled trial ASTEROID 2 is the first study to evaluate systematically the efficacy and safety of different treatment regimens of PRMs in women with UFs. The findings of this study will direct the planning of future clinical trials of vilaprisan. Copyright © 2017 Bayer AG. Published by Elsevier Inc. All rights reserved.

Hyaluronic acid in the treatment of knee osteoarthritis: a systematic review and meta-analysis with emphasis on the efficacy of different products.

PubMed

Colen, Sascha; van den Bekerom, Michel P J; Mulier, Michiel; Haverkamp, Daniël

2012-08-01

Although accepted as a conservative treatment option for knee osteoarthritis, the debate about the effectiveness of intra-articular treatment with hyaluronic acid (HA) is still ongoing because of contrasting outcomes in different clinical studies. Several well designed clinical studies showed a significant improvement in pain at follow-up compared with baseline but no significant improvement comparing the efficacy of HA with placebo (saline) or with other conservative treatment options. Notwithstanding the effectiveness of different types of intra-articular HA products, the question of whether one HA product is better than another is still unanswered. In this systematic review we compare the effects of intra-articularly administered HA with intra-articularly administered placebo in general and, more specifically, the effects of individual HA products with placebo. We also compare the efficacy of different HA products. A systematic review of randomized controlled trials (RCTs) was conducted using databases including MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trial Register and EMBASE. Seventy-four RCTs were included in this systematic review. HA improves pain by approximately 40-50% compared with baseline levels. However, when compared with saline the difference in efficacy is not that large. Due to a large 'placebo effect' of saline (approximately 30% pain reduction, persisting for at least 3 months) we determined a weighted mean difference between the efficacy of HA and saline of just 10.20 using the visual analog scale for pain. It is debatable whether this difference reaches the minimum clinically important difference. Comparing the different HA products, which vary in the molecular weight, concentration, and volume of HA, we were not able to conclude that one brand has a better efficacy than another due to the heterogeneity of the studies and outcomes. In the future it will be important to determine the exact mechanism of action of placebo as this may give us an idea of how to treat osteoarthritis more efficiently. Due to the limitations of this review (follow-up of just 3 months and large heterogeneity of the included studies), it is also important to compare the different HA products to determine which product(s), or which molecular weight range, concentration, or volume of HA is the best option to treat osteoarthritis. Our recommendation is to start large (multicenter) RCTs to give us more evidence about the efficacy of the different HA products.

Academic Efforts and Study Habits among Students in a Principles of Macroeconomics Course.

ERIC Educational Resources Information Center

Okpala, Amon O.; Okpala, Comfort O.; Ellis, Richard

2000-01-01

Students in a macroeconomics course (n=132) were compared on grade point average, academic efficacy, credit hours accumulated, and study hours/habits. Academic efficacy and study habits significantly explained achievement. The amount of study time had no significant impact. Scholastic Assessment Test scores and credit hours explained achievement…

The contribution of perceived parental support to the career self-efficacy of deaf, hard-of-hearing, and hearing adolescents.

PubMed

Michael, Rinat; Most, Tova; Cinamon, Rachel Gali

2013-01-01

The current study examined the contribution of different types of parental support to career self-efficacy among 11th and 12th grade students (N = 160): 66 students with hearing loss (23 hard of hearing and 43 deaf) and 94 hearing students. Participants completed the Career-Related Parent Support Scale, the Career Decision-Making Self-Efficacy Scale, and the Self-Efficacy for the Management of Work-Family Conflict questionnaire. Different aspects of parental support predicted different types of career self-efficacies across the 3 groups. Differences among groups were also found when levels of parental support were compared. The deaf group perceived lower levels of parental career-related modeling and verbal encouragement in comparison with the hard-of-hearing students and higher levels of parental emotional support compared with the hearing participants. No significant differences were found among the research groups in career decision-making self-efficacy and self-efficacy in managing work-family conflict. Implications for theory and practice are discussed.

Comparing the Efficacy of Digital Flashcards versus Paper Flashcards to Improve Receptive and Productive L2 Vocabulary

ERIC Educational Resources Information Center

Dizon, Gilbert; Tang, Daniel

2017-01-01

Several researchers have compared the efficacy of digital flashcards (DFs) versus paper flashcards (PFs) to improve L2 vocabulary and have concluded that using DFs is more effective (Azabdaftari & Mozaheb, 2012; Basoglu & Akdemir, 2010; Kiliçkaya & Krajka, 2010). However, these studies did not utilize vocabulary learning strategies…

Comparative Efficacy of the Picture Exchange Communication System (PECS) versus a Speech-Generating Device: Effects on Requesting Skills

ERIC Educational Resources Information Center

Boesch, Miriam C.; Wendt, Oliver; Subramanian, Anu; Hsu, Ning

2013-01-01

An experimental, single-subject research study investigated the comparative efficacy of the Picture Exchange Communication System (PECS) versus a speech-generating device (SGD) in developing requesting skills for three elementary-age children with severe autism and little to no functional speech. Results demonstrated increases in requesting…

The role of political efficacy on the relationship between facebook use and participatory behaviors: a comparative study of young American and Chinese adults.

PubMed

Chan, Michael; Guo, Jing

2013-06-01

This comparative study of young adults in an established democracy (America) and transitional democracy (Hong Kong) analyzed the impact of political efficacy on the relationship between Internet/Facebook use on political and civic participation. Regression analyses in both samples showed that Facebook use consistently predicted both types of participation. Moreover, there were significant negative interaction effects of political efficacy and Facebook use on participation, such that the relationship between Facebook use and participation was stronger for those with lower levels of political efficacy. The findings provide cross-cultural support for the argument that social media use among youth can facilitate greater political and civic engagement, particularly for those who perceive that they have limited ability to participate and understand political affairs.

Characteristics of the Spanish- and English-Language Self-Efficacy to Manage Diabetes Scales.

PubMed

Ritter, Philip L; Lorig, Kate; Laurent, Diana D

2016-04-01

The purpose of this study was to examine the characteristics of the Spanish-language diabetes self-efficacy scale (DSES-S) and the English-language version (DSES). This study consists of secondary data from 3 randomized studies that administered the DSES-S and DSES at 2 time points. The scales consist of 8 Likert-type 10-point items. Principal component analysis was applied to determine if the scales were unitary or consisted of subscales. Univariate statistics were used to describe the scales. Sensitivity to change was measured by comparing randomized treatment with control groups, where the treatment included methods designed to enhance self-efficacy. General linear models were used to examine the association between the scales and the 8 medical outcomes after controlling for demographic variables. Principal component analysis indicated that there were 2 subscales for both versions: self-efficacy for behaviors and self-efficacy to manage blood levels and medical condition. The measures had similar means across the 3 studies, high internal consistent reliability, values distributed across the entire range, and they showed no evidence of floor effects and little evidence of ceiling effects. The measures were sensitive to change. They were associated with several health indicators and behaviors at baseline, and changes were associated with changes in health measures. The self-efficacy measures behaved consistently across the 3 studies and were highly reliable. Associations with medical indicators and behaviors suggested validity, although further study would be desirable to compare other measures of self-efficacy for people with type 2 diabetes. These brief scales are appropriate for measuring self-efficacy to manage diabetes. © 2016 The Author(s).

What is the role of combination drug therapy in the treatment of overactive bladder? ICI-RS 2014.

PubMed

Visco, Anthony G; Fraser, Matthew O; Newgreen, Donald; Oelke, Matthias; Cardozo, Linda

2016-02-01

The role of combination therapy using oral antimuscarinic medications for the treatment of overactive bladder was proposed at the 2014 International Consultation on Incontinence-Research Society in Bristol, UK to identify key factors to consider when making clinical decisions and to guide future research design. Combination therapy is justified if monotherapy is associated with suboptimal efficacy or bothersome side effects. Combination therapy has the potential to improve efficacy with fewer side effects than monotherapy. Two Phase 2 studies comparing combination therapy that included an antimuscarinic demonstrated improvement in mean voided volume, the primary outcome chosen, with some combinations showing improved micturition frequency and quality of life. The two studies found no evidence of an increased safety risk with combination therapy compared to monotherapy. Future studies should use clinically meaningful or patient reported outcomes such as incontinence episodes when comparing efficacy. If surrogate measures are used, a clear justification should be provided. Cost analyses should be planned for clinical research trials evaluating combination drug therapy. Combination therapy is reasonable when monotherapy has suboptimal efficacy or bothersome side effects. Future research studies evaluating combination therapy for urgency urinary incontinence should ideally(1) be performed as part of a randomized clinical trial,(2) evaluate non-responders to monotherapy,(3) evaluate combination therapy using medications with different mechanisms of action,(4) include clinically meaningful and patient reported outcomes when evaluating efficacy, and(5) include cost-effectiveness analyses to justify any increased cost by showing improvement in efficacy or reduction in side effects. © 2016 Wiley Periodicals, Inc.

Self-efficacy and physical activity in children with congenital heart disease: is there a relationship?

PubMed

Ray, Trenda D; Henry, Karen

2011-04-01

This study examined the relationship between self-efficacy and physical activity in 10- to 14-year-old children with congenital heart disease. Cross-sectional study using self-report instruments. In 84 participants, self-efficacy scores were similar to those published for healthy adolescents, 30.8 as compared with 29.4. Physical activity participation as prescribed by the Centers for Disease Control and Prevention was low (38%). Self-efficacy scores were moderately correlated with physical activity participation (r = .47; p < .001). Interventions are needed to increase physical activity in this high-risk group. Interventions that focus on self-efficacy may be particularly helpful given the link between self-efficacy and physical activity. © 2011, Wiley Periodicals, Inc.

Arthritis self-efficacy scale scores in knee osteoarthritis: a systematic review and meta-analysis comparing arthritis self-management education with or without exercise.

PubMed

Brand, Emily; Nyland, John; Henzman, Cameron; McGinnis, Mark

2013-12-01

Systematic literature review and meta-analysis. To evaluate studies that used arthritis self-management education alone or with exercise to improve Arthritis Self-Efficacy Scale scores of patients with knee osteoarthritis. Increasing self-efficacy may improve patient knee osteoarthritis symptom management and function. MEDLINE (1946-March 2013), CINAHL (1981-March 2013), and PsycINFO (1967-March 2013) databases were searched. Twenty-four studies, including 3163 subjects (women, n = 2547 [80.5%]; mean ± SD age, 65.3 ± 6.5 years), met the inclusion criteria. A meta-analysis was performed to compare the standardized mean difference effect sizes (Cohen d) of randomized controlled studies that used the Arthritis Self-Efficacy Scale pain (13 studies, n = 1906), other symptoms (13 studies, n = 1957), and function (5 studies, n = 399) subscales. Cohen d effect sizes were also calculated for cohort studies that used the Arthritis Self-Efficacy Scale pain (10 studies, n = 1035), other symptoms (9 studies, n = 913), and function (3 studies, n = 141) subscales. Both randomized controlled studies and cohort studies were grouped by intervention type (intervention 1, arthritis self-management education alone; intervention 2, arthritis self-management education with exercise), and effect sizes were compared (Mann-Whitney U tests, P<.05). Interventions that used arthritis self-management education with exercise displayed higher methodological quality scale scores (76.8 ± 13.1 versus 61.6 ± 19.6, P = .03). Statistically significant standardized effect-size differences between intervention 1 and intervention 2 were not observed. Small to moderate effect sizes were observed regardless of whether the intervention included exercise. Exercise interventions used in conjunction with arthritis self-management education programs need to be developed to better enhance the self-efficacy of patients with knee osteoarthritis. Therapy, level 2b-.

Randomized Crossover Study of the Natural Restorative Environment Intervention to Improve Attention and Mood in Heart Failure.

PubMed

Jung, Miyeon; Jonides, John; Northouse, Laurel; Berman, Marc G; Koelling, Todd M; Pressler, Susan J

In heart failure (HF), attention may be decreased because of lowered cerebral blood flow and increased attentional demands needed for self-care. Guided by the Attention Restoration Theory, the objective was to test the efficacy of the natural restorative environment (NRE) intervention on improving attention and mood among HF patients and healthy adults. A randomized crossover pilot study was conducted among 20 HF patients and an age- and education-matched comparison group of 20 healthy adults to test the efficacy of the NRE intervention compared with an active control intervention. Neuropsychological tests were administered to examine attention, particularly attention span, sustained attention, directed attention, and attention switching, at before and after the intervention. Mood was measured with the Positive and Negative Affect Schedule. No significant differences were found in attention and mood after the NRE intervention compared with the control intervention among the HF patients and the healthy adults. In analyses with HF patients and healthy adults combined (n = 40), significant differences were found. Compared with the control intervention, sustained attention improved after the NRE intervention (P = .001) regardless of the presence of HF. Compared with the healthy adults, HF patients performed significantly worse on attention switching after the control intervention (P = .045). The NRE intervention may be efficacious in improving sustained attention in HF patients. Future studies are needed to enhance the NRE intervention to be more efficacious and tailored for HF patients and test the efficacy in a larger sample of HF patients.

Clinical Efficacy Comparison of Saccharomyces Boulardii and Lactic Acid as Probiotics in Acute Pediatric Diarrhea.

PubMed

Asmat, Shakila; Shaukat, Fouzia; Asmat, Raheela; Bakhat, Hafiz Faiq Siddique Gul; Asmat, Tauseef M

2018-03-01

To compare the efficacy of Saccharomyces boulardii and lactic acid producing probiotics in addition to usual treatment regimen to cure diarrhea among children (6 months to 5 years of age). Randomized controlled trial. Department of Pediatrics, Sheikh Zayed Hospital, Lahore, from February to July 2015. Children suffering from acute diarrhea were orally administered Saccharomyces boulardii and lactic acid producing probiotics for 5 days. The efficacy of administered probiotics was monitored. Patients were given Saccharomyces boulardii and lactic acid producing probiotics randomly to remove the bias. Two hundred patients randomly selected for trials; out of which, 100 were treated with Saccharomyces boulardii while the other 100 were supplemented with lactic acid concomitantly along with conventional diarrhea treatment. Results indicated that Saccharomyces boulardii treatment group has significantly higher efficacy rate (45%) compared to lactic acid producing probiotics (26%). This study concluded that Saccharomyces boulardii has a better efficacy compared to lactic acid and may be adopted as a probiotic of choice.

One-month comparative efficacy of three topical ectoparasiticides against adult brown dog ticks (Rhipicephalus sanguineus sensu lato) on mixed-bred dogs in controlled environment.

PubMed

Varloud, Marie; Fourie, Josephus J

2015-05-01

This study was designed to compare the therapeutic and residual efficacy for 1 month of three topical ectoparasiticides on mixed-bred dogs against the brown dog tick, Rhipicephalus sanguineus. Adult dogs (n = 32, 10.8-18.4 kg BW) were allocated to 4 groups (n = 8) and infested with 50 adult ticks on days -8, -2, 7, 14, 21, and 28. Within each group, dogs were treated topically on day 0 with a control solution (CS), Vectra 3D (DPP), Frontline Plus (FM), or K9 Advantix (IP). Ticks were enumerated on dogs 24 h after treatment and each subsequent tick infestation by in situ thumb count assessment without removal and at 48 h by combing and removal. Acaricidal efficacy was calculated using arithmetic means for all 24 and 48 h tick count assessments. From 42 to 56% of the total, infested ticks were found on dogs 48 h post-challenge in the CS group. Therapeutic efficacy for all treatments ranged from 45.5 to 64.6% after 48 h of infestation. Residual efficacy after FM treatment was consistently lower compared to DPP or IP treatments at the 24 h assessments on days 8, 22, 23, and 29. Residual efficacy measured at this last time point was 94.8% for DPP, 83.1% for IP, and 46.9% for FM. This study demonstrates that permethrin-based formulations (DPP and IP) provided a quicker onset of residual protection against brown dog ticks compared to FM. Although DPP and IP are both permethrin-based formulations, DPP exhibited consistently higher residual acaricidal efficacies and was the only treatment that provided >90% protection for 1 month at 24 h post challenge.

Network meta-analysis of first- and second-generation protease inhibitors for chronic hepatitis C genotype 1: efficacy based on RVR and SVR 24.

PubMed

Borba, Helena H; Wiens, Astrid; Steimbach, Laiza M; Perlin, Cassio M; Tonin, Fernanda S; Pedroso, Maria L A; Fernandez-Llimos, Fernando; Pontarolo, Roberto

2017-01-01

This study aimed to compare the efficacy among direct-acting antiviral agents (first and second-generation direct-acting antiviral agents (DAAs)) with placebo and with standard dual therapy (pegylated interferon + ribavirin (Peg-IFN + RBV)) in terms of rapid virologic response (RVR) and sustained virologic response (SVR) in chronic hepatitis C genotype 1 treatment. We performed a systematic review of randomized controlled trials (RCTs) in MEDLINE, International Pharmaceutical Abstracts, Cochrane Library, SCIELO, and Scopus and conducted a network meta-analysis to compare the efficacy of boceprevir (BOC), daclatasvir (DCV), grazoprevir, simeprevir (SMV) and telaprevir (TVR), in treatment-naive and treatment-experienced patients. Sixteen studies encompassing 7171 patients were analysed. Associations between DAAs therapies (IFN-free regimens) could not be addressed since no common comparator was found in the RCTs among these associations and the other agents included in the present analysis. All agents were more efficacious than placebo or Peg-IFN + RBV in terms of RVR, while only BOC and SMV showed statistically significant superiority for the SVR outcome when compared to placebo or standard dual therapy. No significant differences between the DAAs were observed. The analysis prioritized treatment with DCV for both efficacy outcomes. Node-splitting analysis showed that our networks are robust (p > 0.05). The superiority of DAAs over placebo or standard dual therapy with Peg-IFN + RBV was confirmed, indicating the greater efficacy of DCV. This study is the first network meta-analysis that included RVR as an outcome in the evaluation of these agents via indirect comparison. Further investigation should be carried out addressing safety and tolerability outcomes.

Therapeutic efficacy of alternative primaquine regimens to standard treatment in preventing relapses by Plasmodium vivax: A systematic review and meta-analysis.

PubMed

Zuluaga-Idarraga, Lina Marcela; Tamayo Perez, María-Eulalia; Aguirre-Acevedo, Daniel Camilo

2015-12-30

To compare efficacy and safety of primaquine regimens currently used to prevent relapses by P. vivax. A systematic review was carried out to identify clinical trials evaluating efficacy and safety to prevent malaria recurrences by P. vivax of primaquine regimen 0.5 mg/kg/ day for 7 or 14 days compared to standard regimen of 0.25 mg/kg/day for 14 days. Efficacy of primaquine according to cumulative incidence of recurrences after 28 days was determined. The overall relative risk with fixed-effects meta-analysis was estimated. For the regimen 0.5 mg/kg/day/7 days were identified 7 studies, which showed an incidence of recurrence between 0% and 20% with follow-up 60-210 days; only 4 studies comparing with the standard regimen 0.25 mg/kg/day/14 days and no difference in recurrences between both regimens (RR= 0.977, 95% CI= 0.670 to 1.423) were found. 3 clinical trials using regimen 0.5 mg/kg/day/14 days with an incidence of recurrences between 1.8% and 18.0% during 330-365 days were identified; only one study comparing with the standard regimen (RR= 0.846, 95% CI= 0.484 to 1.477). High risk of bias and differences in handling of included studies were found. Available evidence is insufficient to determine whether currently PQ regimens used as alternative rather than standard treatment have better efficacy and safety in preventing relapse of P. vivax. Clinical trials are required to guide changes in treatment regimen of malaria vivax.

Legionella: macrolides or quinolones?

PubMed

Pedro-Botet, L; Yu, V L

2006-05-01

Following the first outbreaks of legionnaire's disease, erythromycin emerged as the treatment of choice without the foundation of rigorous clinical trials. The number of therapeutic failures with erythromycin, as well as the side-effects and drug interactions, led to the consideration of other drugs such as the new macrolides and quinolones for the treatment of legionnaire's disease in the 1990s. In this article, 19 studies in in-vitro intracellular models and seven animal studies that compared macrolides to quinolones were reviewed. Quinolones were found to have greater activity in intracellular models and improved efficacy in animal models compared with macrolides. No randomised trials comparing the clinical efficacy of the new macrolides and new quinolones have ever been performed. Three observational studies totalling 458 patients with legionnaire's disease have compared the clinical efficacy of macrolides (not including azithromycin) and quinolones (mainly levofloxacin). The results suggested that quinolones may produce a superior clinical response compared with the macrolides (erythromycin and clarithromycin) with regard to defervescence, complications, and length of hospital stay. Little data exist for direct comparison of quinolones and azithromycin.

A multi-center, open-label trial to compare the efficacy and pharmacokinetics of Artemether-Lumefantrine in children with severe acute malnutrition versus children without severe acute malnutrition: study protocol for the MAL-NUT study.

PubMed

Denoeud-Ndam, Lise; Dicko, Alassane; Baudin, Elisabeth; Guindo, Ousmane; Grandesso, Francesco; Sagara, Issaka; Lasry, Estrella; Palma, Pedro Pablo; Parra, Angeles M Lima; Stepniewska, Kasia; Djimde, Abdoulaye A; Barnes, Karen I; Doumbo, Ogobara K; Etard, Jean-François

2015-06-12

Malnutrition and malaria frequently coexist in sub-Saharan African countries. Studies on efficacy of antimalarial treatments usually follow the WHO standardized protocol in which severely malnourished children are systematically excluded. Few studies have assessed the efficacy of chloroquine, sulfadoxine-pyrimethamine and quinine in severe acute malnourished children. Overall, efficacy of these treatments appeared to be reduced, attributed to lower immunity and for some antimalarials altered pharmacokinetic profiles and lower drug concentrations. However, similar research on the efficacy and pharmacokinetic profiles of artemisinin-combination therapies (ACTs) and especially artemether-lumefantrine in malnourished children is currently lacking. The main objective of this study is to assess whether artemether-lumefantrine is less efficacious in children suffering from severe acute malnutrition (SAM) compared to non-SAM children, and if so, to what extent this can be attributed to a sub-optimal pharmacokinetic profile. In two sites, Ouelessebougou, Mali and Maradi, Niger, children with uncomplicated microscopically-confirmed P. falciparum malaria aged between 6 and 59 months will be enrolled. Two non-SAM children will be enrolled after the enrolment of each SAM case. Children with severe manifestations of malaria or complications of acute malnutrition needing intensive treatment will be excluded. Treatment intakes will be supervised and children will be followed-up for 42 days, according to WHO guidance for surveillance of antimalarial drug efficacy. Polymerase Chain Reaction genotyping will be used to distinguish recrudescence from re-infection. SAM children will also benefit from the national nutritional rehabilitation program. Outcomes will be compared between the SAM and non-SAM populations. The primary outcome will be adequate clinical and parasitological response at day 28 after PCR correction, estimated by Kaplan-Meier analysis. To assess the pharmacokinetic profile of lumefantrine, a sparse sampling approach will be used with randomized allocation of sampling times (5 per child). A total of 180 SAM children and 360 non-SAM children will be recruited during the 2013 and 2014 malaria seasons. This study will provide important information that is currently lacking on the effect of SAM on therapeutic efficacy and pharmacokinetic profile of artemether-lumefantrine. If it shows lower therapeutic efficacy and decreased lumefantrine concentrations, it would inform dose optimization studies in SAM children. ClinicalTrials.gov: NCT01958905.

Decline in placebo-controlled trial results suggests new directions for comparative effectiveness research.

PubMed

Olfson, Mark; Marcus, Steven C

2013-06-01

The Affordable Care Act offers strong support for comparative effectiveness research, which entails comparisons among active treatments, to provide the foundation for evidence-based practice. Traditionally, a key form of research into the effectiveness of therapeutic treatments has been placebo-controlled trials, in which a specified treatment is compared to placebo. These trials feature high-contrast comparisons between treatments. Historical trends in placebo-controlled trials have been evaluated to help guide the comparative effectiveness research agenda. We investigated placebo-controlled trials reported in four leading medical journals between 1966 and 2010. We found that there was a significant decline in average effect size or average difference in efficacy (the ability to produce a desired effect) between the active treatment and placebo. On average, recently studied treatments offered only small benefits in efficacy over placebo. A decline in effect sizes in conventional placebo-controlled trials supports an increased emphasis on other avenues of research, including comparative studies on the safety, tolerability, and cost of treatments with established efficacy.

Systematic review with network meta-analysis: the efficacy of anti-tumour necrosis factor-alpha agents for the treatment of ulcerative colitis.

PubMed

Stidham, R W; Lee, T C H; Higgins, P D R; Deshpande, A R; Sussman, D A; Singal, A G; Elmunzer, B J; Saini, S D; Vijan, S; Waljee, A K

2014-04-01

Antibodies against tumour necrosis factor-alpha (anti-TNF) are effective therapies in the treatment of ulcerative colitis (UC), but their comparative efficacy is unknown. To perform a network meta-analysis comparing the efficacy of anti-TNF agents in UC. After screening 506 studies, reviewers extracted information on seven studies. Traditional meta-analysis (TMA) was used to compare each anti-TNF agent to placebo. Bayesian network meta-analysis (NMA) was performed to compare the effects of anti-TNF agents to placebo. In addition, sample sizes for comparative efficacy trials were calculated. Compared to placebo, TMA revealed that anti-TNF agents result in a higher likelihood of induction of remission and response (RR: 2.45, 95% CI: 1.72-3.47 and RR: 1.65, 95% CI: 1.37-1.99 respectively) as well as maintenance of remission and response (RR: 2.00, 95% CI: 1.52-2.62 and RR: 1.76, 95% CI: 1.46-2.14 respectively). Individually, infliximab, adalimumab and goliumumab resulted in a higher likelihood of induction and maintenance for both remission and response. NMA found nonsignificant trends in comparisons of the individual agents. The required sample sizes for direct head-to-head trials between infliximab and adalimumab for induction and maintenance are 174 and 204 subjects respectively. This study demonstrates that, compared to placebo, infliximab, adalimumab and golimumab are all effective for the induction and maintenance of remission in ulcerative colitis. However, network meta-analysis demonstrates that no single agent is clinically superior to the others and therefore, other factors such as cost, safety, route of administration and patient preference should dictate our choice of anti-TNF agents. A randomised comparative efficacy trial between infliximab and adalimumab in UC is of practical size and should be performed. © 2014 John Wiley & Sons Ltd.

A proposed framework for evaluating and comparing efficacy estimates in clinical trials of new rotavirus vaccines.

PubMed

Neuzil, Kathleen M; Zaman, K; Victor, John C

2014-08-11

Oral rotavirus vaccines have yielded different point estimates of efficacy when tested in different populations. While population and environmental factors may account for these differences, study design characteristics should also be considered. We review the study design elements of rotavirus vaccine trials that may affect point estimates of efficacy, and propose a framework for evaluating new rotavirus vaccines. Copyright © 2014. Published by Elsevier Ltd.

Efficacy of Helicobacter pylori eradication therapies in Korea: A systematic review and network meta-analysis.

PubMed

Jung, Yoon Suk; Park, Chan Hyuk; Park, Jung Ho; Nam, Eunwoo; Lee, Hang Lak

2017-08-01

The efficacy of Helicobacter pylori eradication regimens may depend on the country where the studies were performed because of the difference in antibiotic resistance. We aimed to analyze the efficacy of H. pylori eradication regimens in Korea where clarithromycin resistance rate is high. We searched for all relevant randomized controlled trials published until November 2016 that investigated the efficacy of H. pylori eradication therapies in Korea. A network meta-analysis was performed to calculate the direct and indirect estimates of efficacy among the eradication regimens. Forty-three studies were identified through a systematic review, of which 34 studies, published since 2005, were included in the meta-analysis. Among 21 included regimens, quinolone-containing sequential therapy for 14 days (ST-Q-14) showed the highest eradication rate (91.4% [95% confidence interval [CI], 86.9%-94.4%] in the intention-to-treat [ITT] analysis). The eradication rate of the conventional triple therapy for 7 days, standard sequential therapy for 10 days, hybrid therapy for 10-14 days, and concomitant therapy for 10-14 days was 71.1% (95% CI, 68.3%-73.7%), 76.2% (95% CI, 72.8%-79.3%), 79.4% (95% CI, 75.5%-82.8%), and 78.3% (95% CI, 75.3%-80.9%), respectively, in the ITT analysis. In the network meta-analysis, ST-Q-14 showed a better comparative efficacy than the conventional triple therapy, standard sequential therapy, hybrid therapy, and concomitant therapy. In addition, tolerability of ST-Q-14 was comparable to those regimens. In Korea, ST-Q-14 showed the highest efficacy in terms of eradication and a comparable tolerability, compared to the results reported for the conventional triple therapy, standard sequential therapy, hybrid therapy, and concomitant therapy. © 2017 John Wiley & Sons Ltd.

Randomised, double-blind, comparative study to evaluate the efficacy and safety of ganaton (itopride hydrochloride) and mosapride citrate in the management of functional dyspepsia.

PubMed

Amarapurkar, Deepak N; Rane, Priya

2004-12-01

Prokinetic agents like itopride hydrochloride and mosapride citrate are commonly used in the management of functional dyspepsia. However, in a recently conducted international, multicentric study, efficacy of 3 different regimens of mosapride was shown to be comparable to placebo. The objective of this phase 4 randomised, double blind, prospective study was to compare the efficacy and safety of ganaton (itopride hydrochloride) and mosapride citrate in the management of functional dyspepsia among patients attending the gastroenterology outpatient department of a tertiary care hospital. Ganaton 50 mg or mosapride citrate 5 mg three times daily before meals for a period of 2 weeks was administered orally. Thirty functional dyspepsia patients in each group (total = 60) were randomised to receive itopride hydrochloride or mosapride citrate treatment for 2 weeks. In itopride versus mosapride groups, global efficacy as judged by patients was excellent in 17 versus 9 (p < 0.05) and poor in 0 versus 3 (p < 0.05). In itopride versus mosapride group global efficacy as judged by physician was excellent in 24 (80%) versus 15 (50%) and poor in 0 (0%) versus 3 (10%) patients respectively. The global efficacy was rated as excellent to good in significantly (p < 0.05) more number of patients in itopride (93.3%) group as compared to mosapride (63.33 %) group. None of the patients reported any adverse events with itopride treatment. In the mosapride group 5 patients (16.7%) reported adverse events. Two patients (6.7%) were withdrawn from mosapride treatment due to adverse events. The physician rated global tolerability ofitopride versus mosapride treatment as excellent in 23 (76.7%) versus 8 (26.7%) (p < 0.05) and poor in 0 (0%) versus 6 (20%) patients respectively. It may be concluded that ganaton (itopride hydrochloride) is superior in efficacy and safety over mosapride citrate in the management of functional dyspepsia.

Examining the Influence of Self-Efficacy and Self-Regulation in Online Learning

ERIC Educational Resources Information Center

Bradley, Rachel L.; Browne, Blaine L.; Kelley, Heather M.

2017-01-01

This paper examined self-efficacy and self-regulatory skills and their influence on achievement in an online learning environment. This study utilized the Online Academic Success Indicators Scale (OASIS). The results of the scale were compared to previous tests measuring the predictive nature of self-efficacy and self-regulatory skills on academic…

Pre-Service Teachers' Efficacy Beliefs and Concerns in Malaysia, England and New Zealand

ERIC Educational Resources Information Center

Berg, David A. G.; Smith, Lisa F.

2014-01-01

This study compared perceptions of teacher efficacy beliefs and concerns about teaching in pre-service teacher cohorts from New Zealand, Malaysia, and England. Participants were primary pre-service teachers from Malaysia (n = 53), New Zealand (n = 100), and England (n = 119), who completed the Teachers' Sense of Efficacy (long form)…

A Comparative Examination of Pre-Service Teacher Self-Efficacy Related to Literacy Instruction

ERIC Educational Resources Information Center

Helfrich, Sara R.; Clark, Sarah K.

2016-01-01

This study investigated differences in self-efficacy to teach literacy between two groups of pre-service teachers. The authors hypothesized that pre-service teachers enrolled in one program focusing on fewer grade levels (K-3) and requiring more literacy-focused courses would have higher self-efficacy than pre-service teachers enrolled in another…

Comparative testing of disinfectant efficacy on planktonic bacteria and bacterial biofilms using a new assay based on kinetic analysis of metabolic activity.

PubMed

Günther, F; Scherrer, M; Kaiser, S J; DeRosa, A; Mutters, N T

2017-03-01

The aim of our study was to develop a new reproducible method for disinfectant efficacy testing on bacterial biofilms and to evaluate the efficacy of different disinfectants against biofilms. Clinical multidrug-resistant strains were chosen as test isolates to ensure practical relevance. We compared the standard qualitative suspension assay for disinfectant testing, which does not take into account biofilm formation, to the new biofilm viability assay that uses kinetic analysis of metabolic activity in biofilms after disinfectant exposure to evaluate disinfectant efficacy. In addition, the efficacy of four standard disinfectants to clinical isolates was tested using both methods. All tested disinfectants were effective against test isolates when in planktonic state using the standard qualitative suspension assay, while disinfectants were only weakly effective against bacteria in biofilms. Disinfectant efficacy testing on planktonic organisms ignores biofilms and overestimates disinfectant susceptibility of bacteria. However, biofilm forming, e.g. on medical devices or hospital surfaces, is the natural state of bacterial living and needs to be considered in disinfectant testing. Although bacterial biofilms are the predominant manner of bacterial colonization, most standard procedures for antimicrobial susceptibility testing and efficacy testing of disinfectants are adapted for application to planktonic bacteria. To our knowledge, this is the first study to use a newly developed microplate-based biofilm test system that uses kinetic analysis of the metabolic activity in biofilms, after disinfectant exposure, to evaluate disinfectant efficacy. Our study shows that findings obtained from disinfectant efficacy testing on planktonic bacteria cannot be extrapolated to predict disinfectant efficacy on bacterial biofilms of clinically relevant multidrug-resistant organisms. © 2016 The Society for Applied Microbiology.

Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: systematic review and meta-analysis.

PubMed

Borba, Helena Hiemisch Lobo; Wiens, Astrid; de Souza, Thais Teles; Correr, Cassyano Januário; Pontarolo, Roberto

2014-04-01

The objectives of this study were to evaluate the efficacy, safety, and tolerability of biologic drugs compared with placebo for systemic lupus erythematosus (SLE) treatment. A systematic review evaluating the efficacy and safety of biologic therapies compared with placebo in adult SLE patients treatment was performed. Data from studies performed before September 2013 were collected from several databases (MEDLINE, Cochrane Library, SCIELO, Scopus, and International Pharmaceutical Abstracts). Study eligibility criteria included randomized, double-blind, placebo-controlled trials; regarding treatment with biologic agents in SLE adult patients; and published in English, German, Portuguese, and Spanish. Extracted data were statistically analyzed in a meta-analysis using the Review Manager (RevMan) 5.1 software. Efficacy outcomes included the SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index) score, the SRI (Systemic Lupus Erythematosus Responder Index), normalization of low C3 (<90 mg/dL), anti-double-stranded DNA positive to negative, and no new BILAG (British Isles Lupus Assessment Group index) 1A or 2B flares. Data on safety profile included adverse events, serious and severe adverse events, death, malignancy, infections, and infusion reactions. We also evaluated withdrawals from treatment due to lack of efficacy or adverse events. Thirteen randomized placebo-controlled trials met the criteria for data extraction for systematic review. A meta-analysis regarding the efficacy and safety of belimumab compared with placebo involving four of these trials was undertaken and the remainder contributed to a meta-analysis of the safety of biologic agents. In addition, two trials allowed the performance of a meta-analysis regarding the efficacy and safety of rituximab compared with placebo. Belimumab was more effective than placebo in most evaluated outcomes. No significant differences in the safety and tolerability data were observed between the belimumab and placebo groups. No differences were observed between the rituximab and placebo groups for the efficacy outcomes or safety parameters. Extracted data from the 13 studies were pooled, allowing assessment of the safety of biologic drugs. The meta-analysis revealed a satisfactory safety profile of these agents when used for SLE treatment, as there were no significant differences between the two evaluated groups (biologic agents and placebo) for all outcomes analyzed. Belimumab exhibited a satisfactory profile regarding efficacy, safety, and tolerability. Rituximab showed no superiority over placebo in terms of efficacy, despite its suitable safety profile. Biologic agents exhibited a good safety profile for SLE treatment, indicating that these agents are promising therapies and should be further investigated.

The Efficacy of Collaborative Strategic Reading in Middle School Science and Social Studies Classes

ERIC Educational Resources Information Center

Boardman, Alison G.; Klingner, Janette K.; Buckley, Pamela; Annamma, Subini; Lasser, Cristin J.

2015-01-01

This study investigated the efficacy of a multi-component reading comprehension instructional approach, Collaborative Strategic Reading (CSR), compared to business-as-usual instructional methods with 19 teachers and 1074 students in middle school social studies and science classrooms in a large urban district. Researchers collaborated with school…

[Clinical assessment of infrasonic phonophoresis efficacy in the treatment of bacterial keratitis].

PubMed

Sidorenko, E I; Filatov, V V; Alimova, Iu M

1999-01-01

Therapeutic efficacy of infrasonic phonophoresis is studied in 30 patients with bacterial keratitis. Control group consisted of 87 patients with the same diagnosis. Clinical studies included comparative evaluation of the therapeutic efficacy of infrasonic phonophoresis and traditional local instillations of the same drugs. Before treatment, visual acuity was the same in both groups, while after regression of inflammation after treatment it was 0.13 higher in the phonophoresis group. Results of clinical studies indicate a higher efficacy of infrasonic therapy of patients with keratitis. The duration of therapy was decreased, number of bed-days decreased, and visual acuity after treatment improved.

Are there any differences in the efficacy and safety of different formulations of Oral 5-ASA used for induction and maintenance of remission in ulcerative colitis? evidence from cochrane reviews.

PubMed

Feagan, Brian G; Chande, Nilesh; MacDonald, John K

2013-08-01

We systematically reviewed and compared the efficacy and safety of oral mesalamine formulations (sustained release, delayed release, and prodrugs) used for induction and maintenance of remission in ulcerative colitis. The main objective of this review was to determine if there are any differences in efficacy or safety among the oral 5-ASA drugs. A literature search in February 2013 identified all applicable randomized trials. Study quality was evaluated using the Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation criteria were used to assess the overall quality of the evidence. Studies were subgrouped by common mesalamine comparators for meta-analysis. Studies were pooled for analysis if they compared equimolar doses of oral 5-ASA. Seventeen studies that evaluated 2925 patients were identified. The risk of bias was low for most factors, although 1 study was single blind and 3 were open label. No difference was observed between oral 5-ASA and comparator 5-ASA formulations in the proportion of patients with clinical remission (relative risk, 0.94; 95% confidence interval, 0.86-1.02), clinical improvement (relative risk, 0.89; 95% confidence interval, 0.77-1.01), or relapse at 12 months (relative risk, 1.01; 95% confidence interval, 0.80-1.28). Subgroup analyses showed no important differences in efficacy. No significant difference was demonstrated in rates of adverse events or withdrawal due to adverse events. There does not seem to be any difference in efficacy or safety among the various formulations of oral 5-ASA. Oral mesalamine is an effective and safe treatment of mild-to-moderate or quiescent ulcerative colitis regardless of the chosen formulation.

Efficacy of Curcuma for Treatment of Osteoarthritis

PubMed Central

Perkins, Kimberly; Sahy, William; Beckett, Robert D.

2016-01-01

The objective of this review is to identify, summarize, and evaluate clinical trials to determine the efficacy of curcuma in the treatment of osteoarthritis. A literature search for interventional studies assessing efficacy of curcuma was performed, resulting in 8 clinical trials. Studies have investigated the effect of curcuma on pain, stiffness, and functionality in patients with knee osteoarthritis. Curcuma-containing products consistently demonstrated statistically significant improvement in osteoarthritis-related endpoints compared with placebo, with one exception. When compared with active control, curcuma-containing products were similar to nonsteroidal anti-inflammatory drugs, and potentially to glucosamine. While statistical significant differences in outcomes were reported in a majority of studies, the small magnitude of effect and presence of major study limitations hinder application of these results. Further rigorous studies are needed prior to recommending curcuma as an effective alternative therapy for knee osteoarthritis. PMID:26976085

A meta-analysis of hypnosis for chronic pain problems: a comparison between hypnosis, standard care, and other psychological interventions.

PubMed

Adachi, Tomonori; Fujino, Haruo; Nakae, Aya; Mashimo, Takashi; Sasaki, Jun

2014-01-01

Hypnosis is regarded as an effective treatment for psychological and physical ailments. However, its efficacy as a strategy for managing chronic pain has not been assessed through meta-analytical methods. The objective of the current study was to conduct a meta-analysis to assess the efficacy of hypnosis for managing chronic pain. When compared with standard care, hypnosis provided moderate treatment benefit. Hypnosis also showed a moderate superior effect as compared to other psychological interventions for a nonheadache group. The results suggest that hypnosis is efficacious for managing chronic pain. Given that large heterogeneity among the included studies was identified, the nature of hypnosis treatment is further discussed.

Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety.

PubMed

Shimonovich, Shachar; Gigi, Roy; Shapira, Amir; Sarig-Meth, Tal; Nadav, Danielle; Rozenek, Mattan; West, Debra; Halpern, Pinchas

2016-11-09

Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine. A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction. The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively. IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications. Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477.

Comparative efficacy of disease-modifying therapies for patients with relapsing remitting multiple sclerosis: Systematic review and network meta-analysis.

PubMed

Fogarty, Emer; Schmitz, Susanne; Tubridy, Niall; Walsh, Cathal; Barry, Michael

2016-09-01

Randomised studies have demonstrated efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis (RRMS). However it is unclear how the magnitude of treatment efficacy varies across all currently available therapies. To perform a systematic review and network meta-analysis to evaluate the comparative efficacy of available therapies in reducing relapses and disability progression in RRMS. A systematic review identified 28 randomised, placebo-controlled and direct comparative trials. A network meta-analysis was conducted within a Bayesian framework to estimate comparative annualised relapse rates (ARR) and risks of disability progression (defined by both a 3-month, and 6-month confirmation interval). Potential sources of treatment-effect modification from study-level covariates and baseline risk were evaluated through meta-regression methods. The Surface Under the Cumulative RAnking curve (SUCRA) method was used to provide a ranking of treatments for each outcome. The magnitude of ARR reduction varied between 15-36% for all interferon-beta products, glatiramer acetate and teriflunomide, and from 50 to 69% for alemtuzumab, dimethyl fumarate, fingolimod and natalizumab. The risk of disability progression (3-month) was reduced by 19-28% with interferon-beta products, glatiramer acetate, fingolimod and teriflunomide, by 38-45% for pegylated interferon-beta, dimethyl fumarate and natalizumab and by 68% with alemtuzumab. Broadly similar estimates for the risk of disability progression (6-month), with the exception of interferon-beta-1b 250mcg which was much more efficacious based on this definition. Alemtuzumab and natalizumab had the highest SUCRA scores (97% and 95% respectively) for ARR, while ranking for disability progression varied depending on the definition of the outcome. Interferon-beta-1b 250mcg ranked among the most efficacious treatments for disability progression confirmed after six months (92%) and among the least efficacious when the outcome was confirmed after three months (30%). No significant modification of relative treatment effects was identified from study-level covariates or baseline risk. Compared with placebo, clear reductions in ARR with disease-modifying therapies were accompanied by more uncertain changes in disability progression. The magnitude of the reduction and the uncertainty associated with treatment effects varied between DMTs. While natalizumab and alemtuzumab demonstrated consistently high ranking across outcomes, with older interferon-beta and glatiramer acetate products ranking lowest, variation in disability progression definitions lead to variation in the relative ranking of treatments. Rigorously conducted comparative studies are required to fully evaluate the comparative treatment effects of disease modifying therapies for RRMS. Copyright © 2016 Elsevier B.V. All rights reserved.

Child versus Family Cognitive-Behavioral Therapy in Clinically Anxious Youth: An Efficacy and Partial Effectiveness Study

ERIC Educational Resources Information Center

Bodden, Denise H. M.; Bogels, Susan M.; Nauta, Maaike H.; De Hann, Else; Ringrose, Jaap; Appelboom, Carla; Brinkman, Andries G.; Appelboom-Geerts, Karen C. M. M. J.

2008-01-01

Child-focused and family-focused cognitive-behavioral therapy (CBT) for 128 children with clinical anxiety disorders and their parents were compared in terms of efficacy and partial effectiveness. Results indicate that 53% of the children under the child CBT became free of anxiety disorders at posttreamtent compared to only 28% under family CBT.…

Efficacy and safety of donepezil, galantamine, and rivastigmine for the treatment of Alzheimer’s disease: A systematic review and meta-analysis

PubMed Central

Hansen, Richard A; Gartlehner, Gerald; Webb, Aaron P; Morgan, Laura C; Moore, Charity G; Jonas, Daniel E

2008-01-01

Pharmacologic treatments for Alzheimer’s disease include the cholinesterase inhibitors donepezil, galantamine, and rivastigmine. We reviewed their evidence by searching MEDLINE®, Embase, The Cochrane Library, and the International Pharmaceutical Abstracts from 1980 through 2007 (July) for placebo-controlled and comparative trials assessing cognition, function, behavior, global change, and safety. Thirty-three articles on 26 studies were included in the review. Meta-analyses of placebo-controlled data support the drugs’ modest overall benefits for stabilizing or slowing decline in cognition, function, behavior, and clinical global change. Three open-label trials and one double-blind randomized trial directly compared donepezil with galantamine and rivastigmine. Results are conflicting; two studies suggest no differences in efficacy between compared drugs, while one study found donepezil to be more efficacious than galantamine, and one study found rivastigmine to be more efficacious than donepezil. Adjusted indirect comparison of placebo-controlled data did not find statistically significant differences among drugs with regard to cognition, but found the relative risk of global response to be better with donepezil and rivastigmine compared with galantamine (relative risk = 1.63 and 1.42, respectively). Indirect comparisons also favored donepezil over galantamine with regard to behavior. Across trials, the incidence of adverse events was generally lowest for donepezil and highest for rivastigmine. PMID:18686744

Systematic Review with Network Meta-Analysis: Comparative Efficacy of Biologics in the Treatment of Moderately to Severely Active Ulcerative Colitis.

PubMed

Vickers, Adrian D; Ainsworth, Claire; Mody, Reema; Bergman, Annika; Ling, Caroline S; Medjedovic, Jasmina; Smyth, Michael

2016-01-01

Biological therapies are increasingly used to treat ulcerative colitis (UC). To compare the efficacy of biologics in adults with moderately-to-severely active UC, stratified by prior exposure to anti-tumour necrosis factor (anti-TNF) therapy. A systematic literature review was undertaken to identify studies of biologics approved for UC. Network meta-analysis was conducted for endpoints at induction and maintenance. Seven studies were included in the meta-analysis of induction treatment for anti-TNF therapy-naïve patients. All biologics were more effective than placebo in inducing clinical response, clinical remission, and mucosal healing. Infliximab demonstrated a statistically significant improvement over adalimumab in clinical response (odds ratio [OR] [95% credible interval (CrI)]: 2.19 [1.35-3.55]), clinical remission (OR [95% CrI]: 2.81 [1.49-5.49]), and mucosal healing (OR [95% CrI]: 2.23 [1.21-4.14]); there were no other significant differences between biologics for induction efficacy. Five studies were included in the meta-analysis of maintenance treatment, two studies rerandomised responder patients at end of induction, and three followed the same patients 'straight through'. To account for design differences, the number of responders at end of induction was assumed to be equivalent to the number rerandomised. Vedolizumab showed significantly different durable clinical response from comparators (OR [95% CrI] infliximab 3.18 [1.14-9.20], golimumab 2.33 [1.04-5.41], and adalimumab 3.96 [1.67-9.84]). In anti-TNF therapy-experienced patients, only vedolizumab and adalimumab could be compared. At induction, no significant differences in efficacy were seen. During maintenance, vedolizumab showed significantly improved rates of mucosal healing versus adalimumab (OR [95% CrI]: 6.72 [1.36-41.0]). This study expands the understanding of comparative efficacies of biologic treatments for UC, encompassing outcomes and populations not previously studied. All biologic treatments were effective for UC during induction. Vedolizumab demonstrated possible clinical benefits in the maintenance setting versus all comparators, irrespective of prior anti-TNF exposure and after adjusting for differences in study design.

Probiotics in Helicobacter pylori eradication therapy: Systematic review and network meta-analysis.

PubMed

Wang, Fan; Feng, Juerong; Chen, Pengfei; Liu, Xiaoping; Ma, Minxing; Zhou, Rui; Chang, Ying; Liu, Jing; Li, Jin; Zhao, Qiu

2017-09-01

Several probiotics were effective in the eradication treatment for Helicobacter pylori (Hp), but their comparative efficacy was unknown. To compare the efficacy of different probiotics when supplemented in Hp eradication therapy. A comprehensive search was conducted to identify all relevant studies in multiple databases and previous meta-analyses. Bayesian network meta-analysis was performed to combine direct and indirect evidence and estimate the relative effects. One hundred and forty studies (44 English and 96 Chinese) were identified with a total of 20,215 patients, and more than 10 probiotic strategies were supplemented in Hp eradication therapy. The rates of eradication and adverse events were 84.1 and 14.4% in probiotic group, while 70.5 and 30.1% in the control group. In general, supplementary probiotics were effective in improving the efficacy of Hp eradication and decreasing the incidence of adverse events, despite of few ineffective subtypes. In triple eradication therapy, there was no significant difference among the effective probiotics, and combined probiotics did not show a better efficacy and tolerance than single use. In triple therapy of 7 days and 14 days, Lactobacillus acidopilus was a slightly better choice, while Saccharomyces boulardii was more applicable for 10-day triple therapy. Compared to placebo, most probiotic strategies were effective when supplemented in Hp eradication therapy. In triple eradication therapy, no probiotic showed a superior efficacy to the others. Compared to single use, combined probiotics could not improve the efficacy or tolerance significantly. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Clinical efficacy of moxifloxacin versus comparator therapies for community-acquired pneumonia caused by Legionella spp.

PubMed

Garau, J; Fritsch, A; Arvis, P; Read, R C

2010-08-01

The aim of this study was to compare outcomes for patients with community-acquired pneumonia (CAP) caused by Legionella spp. following treatment with moxifloxacin or a range of comparator antimicrobial agents. Data were pooled from four sequential I.V./P.O. trials of moxifloxacin in the treatment of CAP. Comparators were ceftriaxone +/- erythromycin, amoxicillin/clavulanate +/- clarithromycin, trovafloxacin, levofloxacin, or ceftriaxone + levofloxacin. Legionella infection was diagnosed by culture, urine antigen testing and/or serology. Clinical success rates for the efficacy-valid (per protocol) populations were recorded at the test-of-cure visit (5-30 days post-therapy). Severity of CAP was determined using the modified American Thoracic Society criteria.Of 1786 efficacy-valid patients, 33 (1.8%) had documented infection with Legionella spp. (moxifloxacin: n=13; comparator: n=20). Of these, 30 cases were identified by serology and/or urine antigen detection and 3 by respiratory culture. The success rate of moxifloxacin vs. comparator therapy was 92.3% vs. 80.0% for the I.V./P.O. trials.Sequential (I.V./P.O.) moxifloxacin demonstrated clinical efficacy that was at least as good as that of comparator treatments for the treatment of CAP due to Legionella.

Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study.

PubMed

Rogawski, Elizabeth T; Platts-Mills, James A; Colgate, E Ross; Haque, Rashidul; Zaman, K; Petri, William A; Kirkpatrick, Beth D

2018-03-05

The low efficacy of rotavirus vaccines in clinical trials performed in low-resource settings may be partially explained by acquired immunity from natural exposure, especially in settings with high disease incidence. In a clinical trial of monovalent rotavirus vaccine in Bangladesh, we compared the original per-protocol efficacy estimate to efficacy derived from a recurrent events survival model in which children were considered naturally exposed and potentially immune after their first rotavirus diarrhea (RVD) episode. We then simulated trial cohorts to estimate the expected impact of prior exposure on efficacy estimates for varying rotavirus incidence rates and vaccine efficacies. Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%. The simulations demonstrated that this expected impact increases linearly with RVD incidence, will be greatest for vaccine efficacies near 50%, and can reach 20% in settings with high incidence and low efficacy. High rotavirus incidence leads to predictably lower vaccine efficacy estimates due to the acquisition of natural immunity in unvaccinated children, and this phenomenon should be considered when comparing efficacy estimates across settings. NCT01375647.

Evaluation of a kojic acid, emblica extract, and glycolic acid formulation compared with hydroquinone 4% for skin lightening.

PubMed

Draelos, Zoe Diana; Yatskayer, Margarita; Bhushan, Pragya; Pillai, Sreekumar; Oresajo, Christian

2010-09-01

Hydroquinone has been the standard prescription agent for skin lightening; however, its use recently has become controversial. Hydroquinone is banned in Europe and parts of Asia because of potential long-term consequences, including carcinogenesis when orally consumed. These concerns have stimulated research to develop alternative skin lightening agents with efficacy comparable to hydroquinone but with a better safety profile. This double-blind study examined the skin lightening ability of a topical formulation containing kojic acid, emblica extract, and glycolic acid compared with prescription generic hydroquinone cream 4%. Eighty multiethnic participants with mild to moderate facial dyschromia were randomly assigned to use the study product or hydroquinone 4% twice daily for 12 weeks to evaluate product efficacy, tolerability, and safety using investigator assessment, participant assessment, and dermospectrophotometry. Study results demonstrated efficacy parity between the study product and hydroquinone 4%. Thus this novel skin lightening preparation is an alternative to hydroquinone 4% for participants with mild to moderate facial dyschromia.

A Comparative Study on the Efficacy of Solifenacin Succinate in Patients with Urinary Frequency with or without Urgency

PubMed Central

Han, Ji-Yeon; Lee, Kyu-Sung; Park, Won Hee; Park, Choal Hee; Lee, Jeong Gu; Lee, Jeong Zoo; Kim, Duk Yoon; Na, Yong Gil; Kwon, Dong Deuk; Choo, Myung-Soo

2014-01-01

Objectives Patients with overactive bladder (OAB) often have trouble perceiving urgency because of difficulties in distinguishing between urgency and desire to void. Empirical antimuscarinic treatment of patients with frequency only may be reasonable if conservative management has failed. We compared the efficacy of solifenacin in patients with frequency with or without urgency. Materials and Methods This multicenter, 12-week, open-label, comparative, non-inferiority clinical trial assessed whether the solifenacin efficacy for frequency without urgency is non-inferior to its efficacy for frequency with urgency. All patients had micturition frequency ≥8 voids/day with or without urgency. Primary efficacy variable: daily frequency change at 12 weeks relative to baseline. Secondary efficacy variables: change at 12 weeks relative to baseline in Patients' Perception of Bladder Condition (PPBC), OAB Symptom Score (OABSS), and Benefit, Satisfaction, Willingness to continue (BSW) questionnaire. Results Of the 286 enrolled patients, 240 (83.9%) completed the study (without urgency n = 115; with urgency n = 125). Full dataset analysis revealed that the groups without and with urgency exhibited significant reductions in daily micturition frequency of −2.49±0.35 (mean ± standard error) and −2.63±0.37, respectively. The lower limit of the 95% two-sided CI of the comparison of the two group means was −1.14, which is smaller than the −0.8 margin of clinical equivalence. The two groups did not differ in improvement in PPBC, OABSS, or BSW scores. Both tolerated the treatment well. Conclusions It was not possible to verify that the solifenacin efficacy for frequency alone was non-inferior to its efficacy for OAB. Nevertheless, solifenacin tended to be effective for frequency regardless of urgency. Trial Registration ClinicalTrials.gov NCT00979472 PMID:25401784

Encapsulation efficacy of natural and synthetic photosensitizers by silica nanoparticles for photodynamic applications.

PubMed

Makhadmeh, Ghaseb Naser; Abdul Aziz, Azlan; Abdul Razak, Khairunisak; Abu Noqta, Osama

2015-12-01

This study analysed the physical effects of Cichorium Pumilum (CP), as a natural photosensitizer (PS), and Protoporphyrin IX (PpIX), as a synthetic PS, encapsulated with silica nanoparticles (SiNPs) in photodynamic therapy. The optimum concentrations of CP and PpIX, needed to destroy Red Blood Cells (RBC), were determined and the efficacy of encapsulated CP and PpIX were compared with naked CP and PpIX was verified. The results confirmed the applicability of CP and PpIX encapsulated in SiNPs on RBCs, and established a relationship between the encapsulated CP and PpIX concentration and the time required to rupture 50% of the RBCs (t50). The CP and PpIX encapsulated in SiNPs exhibited higher efficacy compared with that of naked CP and PpIX, respectively, and CP had less efficacy compared with PpIX.

Efficacy of omeprazole/sodium bicarbonate treatment in gastroesophageal reflux disease: a systematic review.

PubMed

Higuera-de-la-Tijera, Fátima

2018-03-14

Proton pump inhibitors are the most effective medical therapy for gastroesophageal reflux disease, but their onset of action may be slow. To assess the available literature regarding the efficacy of omeprazole/sodium bicarbonate in gastroesophageal reflux patients. A systematic review was conducted. A systematic literature search starting from 2000. Reviewed manuscripts concerning the effectiveness of omeprazole/sodium bicarbonate treatment in gastroesophageal reflux disease were reviewed and the data were extracted. Data were subsequently analyzed with descriptive statistics. This review included information of four studies. Two trials compared the efficacy of omeprazole/sodium bicarbonate versus omeprazole. One study compared the efficacy of once-daily morning or nighttime dosing. And another study compared omeprazole/sodium bicarbonate/alginate versus omeprazole. In total, there was no difference between omeprazole/sodium bicarbonate and omeprazole. However, there is a trend towards more sustained response and a greater proportion of patients with sustained total relief by 30 minutes with omeprazole/sodium bicarbonate. Omeprazole/sodium bicarbonate therapy is not more effective than omeprazole in the treatment of gastroesophageal reflux disease. However, data obtained suggest that it can have a more sustained response and sustained total relief.

The relationship between self-efficacy and transition to work or studies in young adults with disabilities.

PubMed

Andersén, Åsa; Larsson, Kjerstin; Pingel, Ronnie; Kristiansson, Per; Anderzén, Ingrid

2018-03-01

To investigate perceived self-efficacy in unemployed young adults with disabilities, and the association between self-efficacy and transition to work or studies. This prospective cohort study collected data through self-report questionnaires and registry data from a vocational rehabilitation project with young adults, aged 19-29 years. The Swedish Social Insurance Agency, the Swedish Public Employment Service and the participating municipalities identified potential participants for the study. A total of 531 participants were included in the study, of which 249 (47%) were available for analysis. Multinomial logistic regression models were carried out to estimate the associations between self-efficacy, demographic (age, country of birth, education level), health and employment status. The latter was coded as: 'no transition to work or studies', 'transition to studies', and 'transition to work'. A higher level of self-efficacy was associated with increased odds for 'transition to work' (OR = 2.37, p < 0.05). This finding remained consistent when adjusting for possible confounders. The mean value of self-efficacy was low, and participants with lower self-efficacy reported worse self-rated health ( p < 0.001) compared to participants with higher self-efficacy. The results from this study suggest that self-efficacy should be addressed in the vocational rehabilitation of young adults with disabilities in order to support their transition and integration into the labour market.

Community-Based Service-Learning as a Source of Personal Self-Efficacy: Preparing Preservice Elementary Teachers to Teach Science for Diversity

ERIC Educational Resources Information Center

Cone, Neporcha

2009-01-01

Bandura (1997) contends that when compared to other sources of efficacy, mastery experiences, when presented appropriately, have the most powerful influence on self-efficacy. The purpose of this study was to investigate the effects of community-based service learning (CBSL) experiences on preservice elementary teachers' personal self-efficacy…

A Comparative Examination of Canadian and American Pre-Service Teachers' Self-Efficacy Beliefs for Literacy Instruction

ERIC Educational Resources Information Center

Ciampa, Katia; Gallagher, Tiffany L.

2018-01-01

This study explored Canadian and American pre-service elementary teachers' self-efficacy beliefs for literacy instruction, as well as the contextual factors (i.e., course and field experiences) that contribute to these self-efficacy beliefs. Survey data were collected over a two-year period at the beginning and end of a required elementary…

Curcumin-polymeric nanoparticles against colon-26 tumor-bearing mice: cytotoxicity, pharmacokinetic and anticancer efficacy studies.

PubMed

Chaurasia, Sundeep; Chaubey, Pramila; Patel, Ravi R; Kumar, Nagendra; Mishra, Brahmeshwar

2016-01-01

Curcumin (CUR), can inhibit proliferation and induce apoptosis of tumor cells, its extreme insolubility and limited bioavailability restricted its clinical application. An innovative polymeric nanoparticle of CUR has been developed to enhance the bioavailability and anti-cancer efficacy of CUR, in vitro and in vivo. Cationic copolymer Eudragit E 100 was selected as carrier, which can enhance properties of poor bioavailable chemotherapeutic drugs (CUR). The CUR-loaded Eudragit E 100 nanoparticles (CENPs) were prepared by emulsification-diffusion-evaporation method. The in vitro cytotoxicity study of CENPs was carried out using sulphorhodamine B assay. Pharmacokinetic and anti-cancer efficacy of CENPs was investigated in Wister rats as well as colon-26 tumor-bearing mice after oral administration. CENPs showed acceptable particle size and percent entrapment efficiency. In vitro cytotoxicity studies in terms of 50% cell growth inhibition values demonstrated ∼19-fold reduction when treated with CENPs as compared to pure CUR. ∼91-fold increase in Cmax and ∼95-fold increase in AUC0-12h were observed indicating a significant enhancement in the oral bioavailability of CUR when orally administered as CENPs compared to pure CUR. The in vivo anti-cancer study performed with CENPs showed a significant increase in efficacy compared with pure CUR, as observed by tumor volume, body weight and survival rate. The results clearly indicate that the developed polymeric nanoparticles offer a great potential to improve bioavailability and anticancer efficacy of hydrophobic chemotherapeutic drug.

Type D personality and physical inactivity: The mediating effects of low self-efficacy.

PubMed

Wiencierz, Stacey; Williams, Lynn

2017-07-01

Type D personality is associated with health-damaging behaviours among the general population. This study assessed the relationship between Type D personality, physical activity and self-efficacy. A total of 189 participants completed measures of Type D personality, physical activity and self-efficacy. Type D individuals had significantly lower levels of self-efficacy and engaged in significantly less walking and total exercise compared to non-Type D's. Furthermore, self-efficacy fully mediated the relationship between Type D and physical activity. Low levels of self-efficacy may be one mechanism to help explain why Type D individuals engage in more disease-promoting behaviours.

The efficacy of atomoxetine in treating adult attention deficit hyperactivity disorder (ADHD): A meta-analysis of controlled trials.

PubMed

Ravishankar, Vinutha; Chowdappa, Suresh Vedaveni; Benegal, Vivek; Muralidharan, Kesavan

2016-12-01

Atomoxetine, a non-stimulant, is FDA approved drug used in the management of adult ADHD. Since the presentation of adult ADHD is different from the childhood onset condition, there is an urgent need to study the efficacy of atomoxetine on the different symptom domains of adult ADHD. To study the efficacy of atomoxetine in treating adult ADHD compared to placebo, we performed a Medline search for English language publications of Randomized Controlled Trials (RCTs) comparing atomoxetine to placebo for adult ADHD using the keywords "adult ADHD", "atomoxetine" and "placebo". A total of 41 RCTs were returned of which we included 13 relevant RCTs reporting data on 1824 patients with adult ADHD in the analysis. Standardized mean difference between atomoxetine and placebo for the mean baseline-to-endpoint change in total ADHD scores, impulsivity/hyperactivity and inattention scores was calculated, with a 95% confidence limit. Atomoxetine had superior efficacy than placebo on overall adult ADHD scores [-0.45; 95% CI -0.54, -0.35; overall effect p<0.00001]. Atomoxetine was superior to placebo on the domains of both inattention [-0.42; 95% CI -0.49, -0.35; overall effect p<0.00001] and impulsivity/hyperactivity [-0.36; 95% CI -0.44, -0.29; overall effect p<0.00001]. Atomoxetine was significantly more efficacious (p<0.00001) in treating inattention than hyperactivity/impulsivity. Atomoxetine is efficacious in treating adult ADHD compared to placebo, though the efficacy is significantly superior for inattention than hyperactivity/impulsivity. Copyright © 2016. Published by Elsevier B.V.

Efficacy of artesunate-amodiaquine for treating uncomplicated falciparum malaria in sub-Saharan Africa: a multi-centre analysis

PubMed Central

Zwang, Julien; Olliaro, Piero; Barennes, Hubert; Bonnet, Maryline; Brasseur, Philippe; Bukirwa, Hasifa; Cohuet, Sandra; D'Alessandro, Umberto; Djimdé, Abdulaye; Karema, Corine; Guthmann, Jean-Paul; Hamour, Sally; Ndiaye, Jean-Louis; Mårtensson, Andreas; Rwagacondo, Claude; Sagara, Issaka; Same-Ekobo, Albert; Sirima, Sodiomon B; van den Broek, Ingrid; Yeka, Adoke; Taylor, Walter RJ; Dorsey, Grant; Randrianarivelojosia, Milijaona

2009-01-01

Background Artesunate and amodiaquine (AS&AQ) is at present the world's second most widely used artemisinin-based combination therapy (ACT). It was necessary to evaluate the efficacy of ACT, recently adopted by the World Health Organization (WHO) and deployed over 80 countries, in order to make an evidence-based drug policy. Methods An individual patient data (IPD) analysis was conducted on efficacy outcomes in 26 clinical studies in sub-Saharan Africa using the WHO protocol with similar primary and secondary endpoints. Results A total of 11,700 patients (75% under 5 years old), from 33 different sites in 16 countries were followed for 28 days. Loss to follow-up was 4.9% (575/11,700). AS&AQ was given to 5,897 patients. Of these, 82% (4,826/5,897) were included in randomized comparative trials with polymerase chain reaction (PCR) genotyping results and compared to 5,413 patients (half receiving an ACT). AS&AQ and other ACT comparators resulted in rapid clearance of fever and parasitaemia, superior to non-ACT. Using survival analysis on a modified intent-to-treat population, the Day 28 PCR-adjusted efficacy of AS&AQ was greater than 90% (the WHO cut-off) in 11/16 countries. In randomized comparative trials (n = 22), the crude efficacy of AS&AQ was 75.9% (95% CI 74.6–77.1) and the PCR-adjusted efficacy was 93.9% (95% CI 93.2–94.5). The risk (weighted by site) of failure PCR-adjusted of AS&AQ was significantly inferior to non-ACT, superior to dihydroartemisinin-piperaquine (DP, in one Ugandan site), and not different from AS+SP or AL (artemether-lumefantrine). The risk of gametocyte appearance and the carriage rate of AS&AQ was only greater in one Ugandan site compared to AL and DP, and lower compared to non-ACT (p = 0.001, for all comparisons). Anaemia recovery was not different than comparator groups, except in one site in Rwanda where the patients in the DP group had a slower recovery. Conclusion AS&AQ compares well to other treatments and meets the WHO efficacy criteria for use against falciparum malaria in many, but not all, the sub-Saharan African countries where it was studied. Efficacy varies between and within countries. An IPD analysis can inform general and local treatment policies. Ongoing monitoring evaluation is required. PMID:19698172

Striving for Effectiveness in the Treatment of Adolescent Depression: Cognitive Behavior Therapy for Multisite Community Intervention

ERIC Educational Resources Information Center

Curry, John F.; Wells, Karen C.

2005-01-01

The Treatment for Adolescents With Depression Study (TADS) was designed to compare the relative and combined effectiveness of cognitive behavior therapy (CBT) and fluoxetine, each of which had demonstrated efficacy in carefully controlled single-site studies. Models of CBT from these efficacy studies served as the foundation for the TADS…

Exploring self-efficacy as a predictor of disease management.

PubMed

Clark, N M; Dodge, J A

1999-02-01

Self-efficacy is posited in social cognitive theory as fundamental to behavior change. Few health behavior studies have examined self-efficacy prospectively, viewed it as part of a reciprocal behavioral process, or compared self-efficacy beliefs in the same population across different behaviors. This article first discusses self-efficacy in its theoretical context and reviews the available prospective studies. Second, it explores self-efficacy as a predictor of disease management behaviors in 570 older women with heart disease. Although the R2 statistics in each case were modest, the construct is shown to be a statistically significant (p<.05) predictor at both 4 and 12 months postbaseline of several disease management behaviors: using medicine as prescribed, getting adequate exercise, managing stress, and following a recommended diet. Building self-efficacy is likely a reasonable starting point for interventions aiming to enhance heart disease management behaviors of mature female patients.

A pilot study of the comparative efficacy of 100 Hz magnetic seizure therapy and electroconvulsive therapy in persistent depression.

PubMed

Fitzgerald, Paul B; Hoy, Kate E; Elliot, David; McQueen, Susan; Wambeek, Lenore E; Chen, Leo; Clinton, Anne Maree; Downey, Glenn; Daskalakis, Zafiris J

2018-05-01

Magnetic seizure therapy (MST) is a novel brain stimulation technique that uses a high-powered transcranial magnetic stimulation device to produce therapeutic seizures. Preliminary MST studies have found antidepressant effects in the absence of cognitive side effects but its efficacy compared to electroconvulsive therapy (ECT) remains unclear. The aim of this study was to investigate the therapeutic efficacy and cognitive profile of MST compared to standard right unilateral ECT treatment. Thirty-seven patients completed a course of at least nine ECT or MST treatments in a randomized double-blind protocol. Assessments of depression severity and cognition were performed before and after treatment. No difference in the antidepressant effectiveness between the treatments was seen across any of the clinical outcome measures, although the overall response rates in both groups were quite low. In regards to cognition, following MST there were significant improvements in tests of psychomotor speed, verbal memory, and cognitive inhibition, with no reductions in cognitive performance. Following ECT there was significant improvement in only one of the cognitive inhibition tasks. With respect to the between-group comparisons, the MST group showed a significantly greater improvement on psychomotor speed than ECT. MST showed similar efficacy to right unilateral ECT in patients with treatment-resistant depression without cognitive side effects but in a sample that was only of sufficient size to demonstrate relatively large differences in response between the two groups. Future research should aim to optimize the methods of MST administration and compare its efficacy to ECT in large randomized controlled trials. © 2018 Wiley Periodicals, Inc.

Using comparative effectiveness design to improve the generalizability of bipolar treatment trials data: contrasting LiTMUS baseline data with pre-existing placebo controlled trials.

PubMed

Friedman, E S; Calabrese, J R; Ketter, T A; Leon, A C; Thase, M E; Bowden, C L; Sylvia, L G; Ostracher, M J; Severe, J; Iosifescu, D V; Nierenberg, A A; Reilly-Harrington, N A

2014-01-01

Efficacy-based double-blind placebo controlled trials were conducted to establish efficacy and safety for FDA approval. Such designs allowed and encouraged the use of exclusion criteria to improve assay sensitivity and internal validity. The LiTMUS trial increased the representation of real-world individuals with bipolar disorder despite the acknowledgment that this compromises assay sensitivity. To maximize generalizability, LiTMUS used broad inclusion and narrow exclusion criteria: participants experiencing mood symptoms of sufficient intensity (at least with a CGI-BP ≥ 3) that would warrant a change in treatment, and that lithium treatment would be a reasonable therapeutic option if they were randomized to it. At baseline demographic, illness, clinical, and treatment characteristics were collected. The LiTMUS study design and baseline sociodemographic data were compared to previous efficacy studies. As compared to the previous bipolar disorder efficacy studies, LiTMUS participants were of similar age, gender, weight and illness severity; however LiTMUS participants were more racially and ethnically representative of the general population, had a greater number of mood episodes in the past 12 months, more Axis I/II comorbidity, a greater number of prior suicide attempts, and higher functional capacity. LiTMUS was a comparative effectiveness trial that had broad inclusion and minimal exclusion criteria that produced a more representative sample comprised of real-world participants. This design enables the results of the LiTMUS study to be a more representative of real world pharmacotherapuetic outcomes. Limitations include possible selection bias, paucity of sociodemographic data in efficacy trials, and lack of a placebo. Copyright © 2013. Published by Elsevier B.V.

Efficacy and safety of prophylactic levetiracetam in supratentorial brain tumour surgery: a systematic review and meta‐analysis

PubMed Central

Tsaousi, Georgia; Apostolidou, Eirini; Karakoulas, Konstantinos; Kouvelas, Dimitrios; Amaniti, Ekaterini

2016-01-01

Aims The aim of this study was to perform an up‐to‐date systematic review and meta‐analysis on the efficacy and safety of prophylactic administration of levetiracetam in brain tumour patients. Method A systematic review of studies published until April 2015 was conducted using Scopus/Elsevier, EMBASE and MEDLINE. The search was limited to articles reporting results from adult patients, suffering from brain tumour, undergoing supratentorial craniotomy for tumour resection or biopsy and administered levetiracetam in the perioperative period for seizure prophylaxis. Outcomes included the efficacy and safety of levetiracetam, as well as the tolerability of the specific regimen, defined by the discontinuation of the treatment due to side effects. Results The systematic review included 1148 patients from 12 studies comparing levetiracetam with no treatment, phenytoin and valproate, while only 243 patients from three studies, comparing levetiracetam vs phenytoin efficacy and safety, were included in the meta‐analysis. The combined results from the meta‐analysis showed that levetiracetam administration was followed by significantly fewer seizures than treatment with phenytoin (OR = 0.12 [0.03–0.42]: χ2 = 1.76: I2 = 0%). Analysis also showed significantly fewer side effects in patients receiving levetiracetam, compared to other groups (P < 0.05). The combined results showed fewer side effects in the levetiracetam group compared to the phenytoin group (OR = 0.65 [0.14–2.99]: χ2 = 8.79: I2 = 77%). Conclusions The efficacy of prophylaxis with levetiracetam seems to be superior to that with phenytoin and valproate administration. Moreover, levetiracetam use demonstrates fewer side effects in brain tumour patients. Nevertheless, high risk of bias and moderate methodological quality must be taken into account when considering these results. PMID:26945547

Comparable pharmacodynamics, efficacy, and safety of linagliptin 5 mg among Japanese, Asian and white patients with type 2 diabetes.

PubMed

Sarashina, Akiko; Friedrich, Christian; Crowe, Susanne; Patel, Sanjay; Graefe-Mody, Ulrike; Hayashi, Naoyuki; Horie, Yoshiharu

2016-09-01

The efficacy and safety of drugs can vary between different races or ethnic populations because of differences in the relationship of dose to exposure, pharmacodynamic response or clinical efficacy and safety. In the present post-hoc analysis, we assessed the influence of race on the pharmacokinetics, pharmacodynamics, efficacy and safety of monotherapy with the dipeptidyl peptidase-4 inhibitor, linagliptin, in patients with type 2 diabetes enrolled in two comparable, previously reported randomized phase III trials. Study 1 (with a 12-week placebo-controlled phase) recruited Japanese patients only (linagliptin, n = 159; placebo, n = 80); study 2 (24-week trial) enrolled Asian (non-Japanese; linagliptin, n = 156; placebo, n = 76) and white patients (linagliptin, n = 180; placebo, n = 90). Linagliptin trough concentrations were equivalent across study and race groups, and were higher than half-maximal inhibitory concentration, resulting in dipeptidyl peptidase-4 inhibition >80% at trough. Linagliptin inhibited plasma dipeptidyl peptidase-4 activity to a similar degree in study 1 and study 2. Linagliptin reduced fasting plasma glucose concentrations by a similar magnitude across groups, leading to clinically relevant reductions in glycated hemoglobin in all groups. Glycated hemoglobin levels decreased to a slightly greater extent in study 1 (Japanese) and in Asian (non-Japanese) patients from study 2. Linagliptin had a favorable safety profile in each race group. Trough exposure, pharmacodynamic response, and efficacy and safety of linagliptin monotherapy were comparable among Japanese, Asian (non-Japanese) and white patients, confirming that the recommended 5-mg once-daily dose of linagliptin is appropriate for use among different race groups. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Comparing Domain-Specific Physical Activity Efficacy Level between Turkish Adolescent Girls and Boys

ERIC Educational Resources Information Center

Çatikkas, Fatih

2017-01-01

The adolescence period is a very critical developmental period for personality, socializing and promotion of physical activity. In this regard, the aim of this study was to compare domain-specific physical activity efficacy level between adolescent boys and girls. A total of 219 girls (body weight: 57.50 ± 10.44 kg, height: 160.30 ± 7.40 cm, age…

Comparing the Self-Efficacy of Dual Enrollment Students Taking Classes at the High School, at the College, and Online

ERIC Educational Resources Information Center

Wallace, Tyler Lewis

2017-01-01

This quantitative causal comparative study investigated how the modality of course content delivery impacts the self-efficacy of dual enrollment students. The problem was that it is unclear how the benefits of dual enrollment impact different student groups based on the location of the course. The purpose was to verify existing research linking…

Efficacy of Curcuma for Treatment of Osteoarthritis.

PubMed

Perkins, Kimberly; Sahy, William; Beckett, Robert D

2017-01-01

The objective of this review is to identify, summarize, and evaluate clinical trials to determine the efficacy of curcuma in the treatment of osteoarthritis. A literature search for interventional studies assessing efficacy of curcuma was performed, resulting in 8 clinical trials. Studies have investigated the effect of curcuma on pain, stiffness, and functionality in patients with knee osteoarthritis. Curcuma-containing products consistently demonstrated statistically significant improvement in osteoarthritis-related endpoints compared with placebo, with one exception. When compared with active control, curcuma-containing products were similar to nonsteroidal anti-inflammatory drugs, and potentially to glucosamine. While statistical significant differences in outcomes were reported in a majority of studies, the small magnitude of effect and presence of major study limitations hinder application of these results. Further rigorous studies are needed prior to recommending curcuma as an effective alternative therapy for knee osteoarthritis. © The Author(s) 2016.

Observation interventions as a means to manipulate collective efficacy in groups.

PubMed

Bruton, Adam M; Mellalieu, Stephen D; Shearer, David A

2014-02-01

The purpose of this multistudy investigation was to examine observation as an intervention for the manipulation of individual collective efficacy beliefs. Study 1 compared the effects of positive, neutral, and negative video footage of practice trials from an obstacle course task on collective efficacy beliefs in assigned groups. The content of the observation intervention (i.e., positive, neutral, and negative video footage) significantly influenced the direction of change in collective efficacy (p < .05). Study 2 assessed the influence of content familiarity (own team/sport vs. unfamiliar team/sport) on individual collective efficacy perceptions when observing positive footage of competitive basketball performance. Collective efficacy significantly increased for both the familiar and unfamiliar conditions postintervention, with the largest increase for the familiar condition (p < .05). The studies support the use of observation as an intervention to enhance individual perceptions of collective efficacy in group-based activities. The findings suggest that observations of any group displaying positive group characteristics are likely to increase collective efficacy beliefs; however, observation of one's own team leads to the greatest increases.

Early postpartum breast-feeding outcomes and breast-feeding self-efficacy in Turkish mothers undergoing vaginal birth or cesarean birth with different types of anesthesia.

PubMed

Alus Tokat, Merlinda; Serçekuş, Pinar; Yenal, Kerziban; Okumuş, Hülya

2015-04-01

To compare the breast-feeding outcomes and breast-feeding self-efficacy, in the first 24 postpartum hours, of mothers who underwent vaginal birth, cesarean birth with epidural anesthesia, and cesarean birth with general anesthesia. A comparative study was conducted in Turkey. A total of 334 mothers participated. Data were evaluated through descriptive data form, breast-feeding outcomes form, and the Breastfeeding Self-Efficacy Scale. It was observed that the mothers who had cesarean birth with general anesthesia experienced more breast-feeding problems. With regard to breast-feeding self-efficacy, all the groups were similar. For reducing breast-feeding problems, nurses should provide more care and support to mothers undergoing cesarean birth. Therefore, the fact that the breast-feeding self-efficacy was similar among the groups might be related to culture. © 2014 NANDA International, Inc.

Novel Composite Efficacy Measure To Demonstrate the Rationale and Efficacy of Combination Antiviral–Anti-Inflammatory Treatment for Recurrent Herpes Simplex Labialis

PubMed Central

Levin, Myron J.; Tyring, Stephen K.; Spruance, Spotswood L.

2014-01-01

Historically, the primary target for research and treatment of recurrent herpes simplex labialis (HSL) has been limited to inhibiting herpes simplex virus (HSV) replication. Antiviral monotherapy, however, has proven only marginally effective in curtailing the duration and severity of recurrent lesions. Recently, the role of inflammation in the progression and resolution of recurrences has been identified as an additional target. This was evaluated in a randomized study comparing combination topical 5% acyclovir-1% hydrocortisone cream (AHC) with 5% acyclovir alone (AC; in the AHC vehicle) and the vehicle. The efficacy of each topical therapy was evaluated for cumulative lesion size—a novel composite efficacy endpoint incorporating episode duration, lesion area, and proportion of nonulcerative lesions. In that study, cumulative lesion area was significantly decreased with AHC compared with AC (25% decrease; P < 0.05) and the vehicle (50% decrease; P < 0.0001). As research continues in this arena, cumulative lesion area should be included as a measure of efficacy in clinical trials of recurrent HSL therapies. PMID:24342632

Parenting self-efficacy moderates linkage between partner relationship dissatisfaction and avoidant infant-mother attachment: A Dutch study.

PubMed

Cassé, Julie F H; Oosterman, Mirjam; Schuengel, Carlo

2016-12-01

The early infant-mother attachment relationship is part of a network of close relationships in which the relationship between parents is especially relevant. Evidence for linkages between maternal satisfaction with the partner relationship and infant-mother attachment is equivocal. The current study tested whether associations between partner relationship dissatisfaction and infant-mother attachment quality might be conditional on mothers' parenting self-efficacy. The bivariate effect of partner relationship dissatisfaction on infant-mother attachment as well as moderation of this effect by parenting self-efficacy was tested in a sample of 260 infant-mother dyads 1 year after birth. There was no direct effect of partner dissatisfaction on attachment. Unexpectedly, for high parenting self-efficacy, greater partner dissatisfaction increased the odds of an avoidant infant attachment (compared with a disorganized) whereas, for low parenting self-efficacy, greater partner dissatisfaction decreased the odds of an avoidant infant attachment (compared with secure and disorganized). Findings underline the importance of parenting cognitions for understanding contextual factors of infant-mother attachment quality. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Bullying Behaviors and Self Efficacy among Nursing Students at Clinical Settings: Comparative Study

ERIC Educational Resources Information Center

Kassem, Awatef Hassan

2015-01-01

Background: Nursing students who experienced bullying behaviors feel anger and missing their concentration, their capability to achieve a desired outcome. Also self-efficacy, often referred to as self-confidence, is essential to nursing students' ability and performance in the clinical setting. Aim: Study aimed to examine relation between bullying…

The Efficacy of a Vocabulary Intervention for Dual-Language Learners with Language Impairment

ERIC Educational Resources Information Center

Restrepo, Maria Adelaida; Morgan, Gareth P.; Thompson, Marilyn S.

2013-01-01

Purpose: In this study, the authors evaluated the efficacy of a Spanish-English versus English-only vocabulary intervention for dual-language learners (DLLs) with language impairment compared to mathematics intervention groups and typically developing controls with no intervention. Further, in this study the authors also examined whether the…

The Efficacy of Electronic Books in Fostering Kindergarten Children's Emergent Story Understanding

ERIC Educational Resources Information Center

de Jong, Maria T.; Bus, Adriana G.

2004-01-01

A counterbalanced, within-subjects design was carried out to study the efficacy of electronic books in fostering kindergarten children's emergent story understanding. The study compared effects of children's independent reading of stories electronically with effects of printed books read aloud by adults. Participants were 18 four- to five-year-old…

Increasing Students' Perceived Sociopolitical Empowerment through Online and Face-to-Face Community Psychology Seminars

ERIC Educational Resources Information Center

Francescato, Donata; Solimeno, Andrea; Mebane, Minou Ella; Tomai, Manuela

2009-01-01

Community psychology theorists underline the importance of promoting sociopolitical empowerment, but few studies have been conducted on the evaluation of the efficacy of empowering programs among university students. The authors report two studies: the first, with 216 psychology majors, compared the efficacy of face-to-face and online community…

Comparing student clinical self-efficacy and team process outcomes for a DEU, blended, and traditional clinical setting: A quasi-experimental research study.

PubMed

Plemmons, Christina; Clark, Michele; Feng, Du

2018-03-01

Clinical education is vital to both the development of clinical self-efficacy and the integration of future nurses into health care teams. The dedicated education unit clinical teaching model is an innovative clinical partnership, which promotes skill development, professional growth, clinical self-efficacy, and integration as a team member. Blended clinical teaching models are combining features of the dedicated education unit and traditional clinical model. The aims of this study are to explore how each of three clinical teaching models (dedicated education unit, blended, traditional) affects clinical self-efficacy and attitude toward team process, and to compare the dedicated education unit model and blended model to traditional clinical. A nonequivalent control-group quasi-experimental design was utilized. The convenience sample of 272 entry-level baccalaureate nursing students included 84 students participating in a dedicated education unit model treatment group, 66 students participating in a blended model treatment group, and 122 students participating in a traditional model control group. Perceived clinical self-efficacy was evaluated by the pretest/posttest scores obtained on the General Self-Efficacy scale. Attitude toward team process was evaluated by the pretest/posttest scores obtained on the TeamSTEPPS® Teamwork Attitude Questionnaire. All three clinical teaching models resulted in significant increases in both clinical self-efficacy (p=0.04) and attitude toward team process (p=0.003). Students participating in the dedicated education unit model (p=0.016) and students participating in the blended model (p<0.001) had significantly larger increases in clinical self-efficacy compared to students participating in the traditional model. These findings support the use of dedicated education unit and blended clinical partnerships as effective alternatives to the traditional model to promote both clinical self-efficacy and team process among entry-level baccalaureate nursing students. Copyright © 2017 Elsevier Ltd. All rights reserved.

Science Teacher Efficacy and Outcome Expectancy as Predictors of Students' End-of-Instruction (EOI) Biology I Test Scores

ERIC Educational Resources Information Center

Angle, Julie; Moseley, Christine

2009-01-01

The purpose of this study was to compare teacher efficacy beliefs of secondary Biology I teachers whose students' mean scores on the statewide End-of-Instruction (EOI) Biology I test met or exceeded the state academic proficiency level (Proficient Group) to teacher efficacy beliefs of secondary Biology I teachers whose students' mean scores on the…

"A Compliment Is All I Need"--Teachers Telling Principals How to Promote Their Staff's Self-Efficacy

ERIC Educational Resources Information Center

Kass, Efrat

2013-01-01

The purpose of the present study is to compare the perceptions of teachers representing opposite ends of the self-efficacy spectrum regarding the effects of the principal's behavior on their professional self-efficacy. In the first quantitative stage, a statistical procedure was conducted to identify the two groups of teachers: a group of 16…

Cleanliness in the Root Canal System: An Scanning Electron Microscopic Evaluation of Manual and Automated Instrumentation using 4% Sodium Hypochlorite and EDTA (Glyde File Prep)―An in vitro Study

PubMed Central

Meshram, GK

2010-01-01

ABSTRACT Aim : To assess the cleaning efficacy of manual and automated instrumentation using 4% sodium hypochlorite singly and in combination with Glyde file Prep as root canal irrigant. Methodology : The study utilized 40 extracted human permanent premolars with single, straight and fully formed root. The teeth were then divided into four groups of ten each, Group I and II were prepared by manual instruments with 4% sodium hypochlorite used as irrigant singly [Group I] or in combination with Glyde file prep. Group III and IV were prepared by automated instruments at 250 rpm with 4% sodium hypochlorite as irrigant singly [Group III] and in combination with glyde file prep [Group IV] automated instrumentation. After completion of the root canal preparation the canal, teeth were prepared for SEM examination. These photomicrographs were qualitatively evaluated using criteria. Overall cleanliness, presence or absence of the smear layer, presence or absence of the debris, patency of the opening of dentinal tubules. Results : When comparing the cleansing efficacy of manual and automated instrumentation using 4% sodium hypochlorite better cleansing was there with manual instrumentation. When comparing the cleansing efficacy of manual and automated instrumentation using combination regime cleansing is better with automated instrumentation. When comparing the cleansing efficacy of manual instrumentation using 4% sodium hypochlorite singly and in combination with EDTA, the combination regime led to better cleansing. When comparing the cleansing efficacy of automated instrumentation using 4% sodium hypochlorite singly and in combination regime lead to better cleansing. Conclusion : Neither of instrumentation technique, nor irrigating regimes were capable of providing a completely clean canal. Automated instrumentation with a combination of sodium hypochlorite & EDTA resulted the best cleansing efficacy. PMID:27616839

Scientific Inquiry Self-Efficacy and Computer Game Self-Efficacy as Predictors and Outcomes of Middle School Boys' and Girls' Performance in a Science Assessment in a Virtual Environment

NASA Astrophysics Data System (ADS)

Bergey, Bradley W.; Ketelhut, Diane Jass; Liang, Senfeng; Natarajan, Uma; Karakus, Melissa

2015-10-01

The primary aim of the study was to examine whether performance on a science assessment in an immersive virtual environment was associated with changes in scientific inquiry self-efficacy. A secondary aim of the study was to examine whether performance on the science assessment was equitable for students with different levels of computer game self-efficacy, including whether gender differences were observed. We examined 407 middle school students' scientific inquiry self-efficacy and computer game self-efficacy before and after completing a computer game-like assessment about a science mystery. Results from path analyses indicated that prior scientific inquiry self-efficacy predicted achievement on end-of-module questions, which in turn predicted change in scientific inquiry self-efficacy. By contrast, computer game self-efficacy was neither predictive of nor predicted by performance on the science assessment. While boys had higher computer game self-efficacy compared to girls, multi-group analyses suggested only minor gender differences in how efficacy beliefs related to performance. Implications for assessments with virtual environments and future design and research are discussed.

Efficacy of photodynamic therapy in the treatment of symptomatic oral lichen planus: A systematic review.

PubMed

Al-Maweri, Sadeq Ali; Ashraf, Sajna; Kalakonda, Butchibabu; Halboub, Esam; Petro, Waleed; AlAizari, Nader Ahmed

2018-04-01

The aim of this study was to systematically review the efficacy of photodynamic therapy (PDT) in the management of symptomatic oral lichen planus (OLP). PubMed/MEDLINE, Scopus, and ISI Web of knowledge were searched until July 2017, using the following keywords: OLP, erosive lichen planus, lichen planus, and PDT. Five clinical studies were included. The risk of bias was considered high in 4 studies and moderate in 1 study. The efficacy of PDT was compared with topical corticosteroids in all included studies. Laser wavelengths, duration of irradiation, and power density ranged between 420-660 nm, 30 seconds to 10 minutes, and 10-500 mW/cm 2 , respectively. All studies reported PDT to be effective in the management of symptomatic OLP. Two studies reported PDT to be as effective as corticosteroids, 1 study reported a better efficacy of PDT compared to corticosteroids, whereas 2 studies found PDT to be inferior to corticosteroids. The limited available evidence suggests that PDT is an effective treatment option for the management of OLP. However, due to the limited number of studies included in this review and heterogeneity among these studies, more well-designed clinical trials with adequate sample sizes are highly warranted. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Effects of a one session spouse-support enhancement childbirth education on childbirth self-efficacy and perception of childbirth experience in women and their husbands].

PubMed

Eom, So Ye; Kim, Eun Sil; Kim, Hyun Jung; Bang, Yang Ok; Chun, Nami

2012-08-01

This study was conducted to evaluate the effect of a one-session spouse-support enhancement childbirth education on childbirth self-efficacy and perception of childbirth experience. The design of this study was a nonequivalent control group pretest-posttest experiment. The participants in the study were 31 couples in the experimental group and 30 in the control group. The experimental couples were provided with one session on spouse-support enhancement childbirth education the night before delivery. Data were collected at two hours after delivery using the Childbirth Self-Efficacy Inventory (CBSEI) and perception of childbirth experience scale. Data were analyzed using PASW statistics 18 program. Frequencies, percentage, mean, χ² test, t-test were used for data analysis. Childbirth self-efficacy significantly increased in the experimental group as compared to the control group, but there was no significant difference in perception of childbirth experience in the experimental group compared to the control group. The results suggest that a one-session childbirth education has beneficial effects on enhancing childbirth self-efficacy in pregnant couples. A one-session spouse-support enhancement childbirth education is recommended as an effective nursing intervention to promote couple's childbirth self-efficacy and it is also recommended that modifications of program to promote women's childbirth experience should be considered.

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

PubMed

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

2016-02-01

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

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1.

PubMed

Huang, David B; O'Riordan, William; Overcash, J Scott; Heller, Barry; Amin, Faisal; File, Thomas M; Wilcox, Mark H; Torres, Antoni; Dryden, Matthew; Holland, Thomas L; McLeroth, Patrick; Shukla, Rajesh; Corey, G Ralph

2018-04-03

Our objective in this study was to demonstrate the safety and efficacy of iclaprim compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs). REVIVE-1 was a phase 3, 600-patient, double-blinded, randomized (1:1), active-controlled trial among patients with ABSSSI that compared the safety and efficacy of iclaprim 80 mg fixed dose with vancomycin 15 mg/kg, both administered intravenously every 12 hours for 5-14 days. The primary endpoint of this study was a ≥20% reduction in lesion size (early clinical response [ECR]) compared with baseline among patients randomized to iclaprim or vancomycin at the early time point (ETP), 48 to 72 hours after the start of administration of study drug in the intent-to-treat population. ECR among patients who received iclaprim and vancomycin at the ETP was 80.9% (241 of 298) of patients receiving iclaprim compared with 81.0% (243 of 300) of those receiving vancomycin (treatment difference, -0.13%; 95% confidence interval, -6.42%-6.17%). Iclaprim was well tolerated in the study, with most adverse events categorized as mild. Iclaprim achieved noninferiority (10% margin) at ETP compared with vancomycin and was well tolerated in this phase 3 clinical trial for the treatment of ABSSSI. Based on these results, iclaprim appears to be an efficacious and safe treatment for ABSSSI suspected or confirmed to be due to gram-positive pathogens. NCT02600611.

Meta-analysis of randomized, controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis.

PubMed

Tey, Hong Liang; Tan, Andy Soon Leong; Chan, Yuin Chew

2011-04-01

Griseofulvin has been the standard treatment for tinea capitis but newer antifungal agents, particularly terbinafine, are increasingly being used because of their shorter duration of treatment and more consistent absorption rates. We sought to compare the efficacy of oral griseofulvin and oral terbinafine in the treatment of tinea capitis. A search of MEDLINE, EMBASE, Cochrane Central Register of Clinical Trials, and the Cochrane Skin Group Ongoing Skin Trials Register was performed up to January 2010 for randomized controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis in immunocompetent patients. The primary outcome measure was the complete cure rate. The mycological and clinical cure rates and adverse effects were secondary outcome measures. Pooling of treatment effect was accomplished using a random effects model and the I(2) test was used to check for heterogeneity among the studies. Seven studies involving 2163 subjects were included. There was no significant difference in efficacy between griseofulvin (mean duration of treatment 8 weeks, range 6-12 weeks) and terbinafine (mean duration of treatment 4 weeks, range 2-6 weeks); odds ratio = 1.22 favoring terbinafine (95% confidence interval [CI] = 0.785-1.919; P = .37). In the pooled analysis of 5 studies in which Trichophyton species were the predominant (≥65%) pathogenic dermatophyte, terbinafine showed a trend toward greater efficacy (odds ratio 1.49; 95% CI = 0.975-2.277; P = .065). Subgroup analysis revealed that terbinafine was more efficacious than griseofulvin in treating Trichophyton species (1.616; 95% CI = 1.274-2.051; P < .001) and griseofulvin was more efficacious than terbinafine in treating Microsporum species (0.408; 95% CI = 0.254-0.656; P < .001). Both griseofulvin and terbinafine demonstrated good safety profiles in the studies. Data on efficacy of griseofulvin and terbinafine for separate groups of Trichophyton and Microsporum species were not available from every study. In the subgroup analysis of Microsporum species, data from only 3 studies were available. This meta-analysis suggests that terbinafine is more efficacious than griseofulvin in treating tinea capitis caused by Trichophyton species, whereas griseofulvin is more efficacious than terbinafine in treating tinea capitis caused by Microsporum species. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Rationale for the tinnitus retraining therapy trial.

PubMed

Formby, Craig; Scherer, Roberta

2013-01-01

The Tinnitus Retraining Therapy Trial (TRTT) is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT) and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1) directive counseling and sound therapy using conventional sound generators; (2) directive counseling and placebo sound generators; or (3) standard of care as administered in the military. Study centers include a Study Chair's Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ) score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators) with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant's life.

Effect of intensive diet and exercise on self-efficacy in overweight and obese adults with knee osteoarthritis: The IDEA randomized clinical trial.

PubMed

Mihalko, Shannon L; Cox, Phillip; Beavers, Daniel P; Miller, Gary D; Nicklas, Barbara J; Lyles, Mary; Hunter, David J; Eckstein, Felix; Guermazi, Ali; Loeser, Richard F; DeVita, Paul; Messier, Stephen P

2018-04-04

Physical activity decreases the risk of osteoarthritis (OA)-related disability; however, pain and lack of confidence represent barriers for older adults with knee OA. The purpose of this study was to examine (a) the baseline associations among self-efficacy and physical activity, function, and pain; (b) longitudinal changes in self-efficacy; and (c) whether self-efficacy mediates treatment effects on clinical outcomes. The Intensive Diet and Exercise for Arthritis (IDEA) trial was a single-blind, randomized controlled 18-month study including 454 overweight/obese older adults (M age = 66 years) with knee OA. Participants were randomized to one of three interventions: exercise (E), diet-induced weight loss (D), or both (D+E). Self-efficacy for gait, balance, and walking duration were assessed at baseline, 6 months, and 18 months. Baseline associations were tested using Pearson correlations, and group least squares means were compared using mixed linear models at follow-up. Participants with higher self-efficacy reported significantly better physical function and less knee pain at baseline, walked farther (6-min walk), and were more physically active (all |r| > 0.12, all p < .01). Significant differences between groups were detected for all self-efficacy measures at 18 months; the D+E group reported significantly (all p < .005) higher self-efficacy for gait, walking duration, and balance compared with the D- or E-only groups. Self-efficacy significantly (p < .05) mediated treatment effects on physical function and pain at 18 months. A combined intervention of diet-induced weight loss and exercise is the treatment of choice to maximize self-efficacy, improve physical function, and reduce pain in overweight/obese adults with knee OA.

Comparative Efficacy and Acceptability of Anti-Diabetic Agents for Alzheimer's Disease and Mild Cognitive Impairment: A Systematic Review and Network Meta-analysis.

PubMed

Cao, Bing; Rosenblat, Joshua D; Brietzke, Elisa; Park, Caroline; Lee, Yena; Musial, Natalie; Pan, Zihang; Mansur, Rodrigo B; McIntyre, Roger S

2018-05-23

The current meta-analysis compares the efficacy (i.e., pro-cognitive effects) and acceptability of anti-diabetic agents for Alzheimer's disease (AD) and mild cognitive impairment (MCI). Cochrane Library (CENTRAL), PubMed/MEDLINE, EMBASE and PsycINFO were searched from inception to January 15, 2018 for randomized controlled trials (RCTs) comparing anti-diabetic agents with placebo and/or another active anti-diabetic agent for the treatment of AD or MCI. Nineteen eligible studies (n = 4,855) evaluating the effects of six different anti-diabetic drugs (i.e., intranasal insulin, pioglitazone, rosiglitazone, metformin, sitagliptin and liraglutide) were included. The results of 29 pairwise comparisons indicated that cognition was significantly improved in subjects treated with anti-diabetic agents compared to placebo. Pioglitazone 15-30 mg demonstrated the greatest efficacy compared to placebo in network meta-analysis. No significant differences in acceptability were identified when comparing agents with each other and with placebo. The current findings indicate a pro-cognitive class effect of anti-diabetic agents in AD/MCI. Other anti-diabetic agents should also be investigated in future studies. This study is registered with PROSPERO (CRD42018085967). This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Efficacy of Pharmacist Based Diabetes Educational Interventions on Clinical Outcomes of Adults With Type 2 Diabetes Mellitus: A Network Meta-Analysis.

PubMed

Bukhsh, Allah; Khan, Tahir M; Lee, Shaun W H; Lee, Learn-Han; Chan, Kok-Gan; Goh, Bey-Hing

2018-01-01

Background: Comparative efficacy of different pharmacist based interventions on glycemic control of type 2 diabetes patients is unclear. This review aimed to evaluate and compare the efficacy of different pharmacist based interventions on clinical outcomes of type 2 diabetes patients. Methods: A systematic search was conducted across five databases from date of database inception to September 2017. All randomized clinical trials evaluating the efficacy of pharmacist based interventions on type 2 diabetes patients were included for network meta-analysis (NMA). The protocol is available with PROSPERO (CRD42017078854). Results: A total of 43 studies, involving 6259 type 2 diabetes patients, were included. NMA demonstrated that all interventions significantly lowered glycosylated hemoglobin (HbA1c) levels compared to usual care, but there was no statistical evidence from this study that one intervention was significantly better than the other for reducing HbA1c levels. Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy for reducing HbA1c levels [-0.86, 95% CI -0.983, -0.727; p < 0.001]. Pharmacist based diabetes education plus pharmaceutical care was observed to be statistically significant in lowering levels of systolic blood pressure [-4.94; 95%CI -8.65, -1.23] and triglycerides levels [-0.26, 95%CI -0.51, -0.01], as compared to the interventions which involved diabetes education by pharmacist, and for body mass index (BMI) [-0.57; 95%CI -1.25, -0.12] in comparison to diabetes education by health care team involving pharmacist as member. Conclusion: The findings of this review demonstrate that all interventions had a significantly positive effect on HbA1c, but there was no statistical evidence from this study that one intervention was significantly better than the other for achieving glycemic control.Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy on HbA1c and rest of the clinical outcomes.

Anti-bacterial efficacy of alcoholic hand rubs in the Kenyan market, 2015.

PubMed

Ochwoto, Missiani; Muita, Lucy; Talaam, Keith; Wanjala, Cecilia; Ogeto, Frank; Wachira, Faith; Osman, Saida; Kimotho, James; Ndegwa, Linus

2017-01-01

Hand hygiene is known to be effective in preventing hospital and community-acquired infections. The increasing number of hand sanitizer brands in Kenyan hospitals and consumer outlets is of concern. Thus the main aim of this study was to evaluate the anti-bacterial efficacy and organoleptic properties of these hand sanitizers in Kenya. This was an experimental, laboratory-based study of 14 different brands of hand sanitizers (coded HS1-14) available in various retail outlets and hospitals in Kenya. Efficacy was evaluated using standard non-pathogenic Escherichia coli (ATCC 25922), Staphylococcus aureus (ATCC 25923) and Pseudomonas aeruginosa (ATCC 27853) as per the European Standard (EN). The logarithmic reduction factors (RF) were assessed at baseline and after treatment, and log reduction then calculated. Ten and 25 healthy volunteers participated in the efficacy and organoleptic studies respectively. Four (28.6%) hand sanitizers (HS12, HS9, HS13 and HS14) showed a 5.9 reduction factor on all the three bacteria strains. Seven (50%) hand sanitizers had efficacies of <3 against all the three bacteria strains used. Efficacy on E. Coli was higher compared to the other pathogens. Three hand sanitizers were efficacious on one of the pathogens and not the other. In terms of organoleptic properties, gel-based formulations were rated far higher than the liquid based formulations brands. Fifty percent (50%) of the selected hand sanitizers in the Kenyan market have efficacy that falls below the World Health Organization (WHO) and DIN EN 1500:2013. Of the 14 hand sanitizers found in the Kenyan market, only four showed efficacies that were comparable to the WHO-formulation. There is a need to evaluate how many of these products with <3 efficacy that have been incorporated into the health system for hand hygiene and the country's policy on regulations on their usage.

The Efficacy of an Immersive 3D Virtual versus 2D Web Environment in Intercultural Sensitivity Acquisition

ERIC Educational Resources Information Center

Coffey, Amy Jo; Kamhawi, Rasha; Fishwick, Paul; Henderson, Julie

2017-01-01

Relatively few studies have empirically tested computer-based immersive virtual environments' efficacy in teaching or enhancing pro-social attitudes, such as intercultural sensitivity. This channel study experiment was conducted (N = 159) to compare what effects, if any, an immersive 3D virtual environment would have upon subjects' intercultural…

Meta-Analysis of Cognitive-Behavioral Treatments for Generalized Anxiety Disorder: A Comparison with Pharmacotherapy

ERIC Educational Resources Information Center

Mitte, Kristin

2005-01-01

The efficacy of (cognitive) behavioral therapy ([C]BT) for generalized anxiety disorder was investigated and compared with the efficacy of pharmacological therapy using meta-analytic techniques. A total of 65 (C)BT studies and pharmacological studies were included. (C)BT was more effective than control conditions. The results of the comparison…

Experience and challenges presented by a multicenter crossover study of combination analgesic therapy for the treatment of painful HIV-associated polyneuropathies.

PubMed

Harrison, Taylor; Miyahara, Sachiko; Lee, Anthony; Evans, Scott; Bastow, Barbara; Simpson, David; Gilron, Ian; Dworkin, Robert; Daar, Eric S; Wieclaw, Linda; Clifford, David B

2013-07-01

There is limited evidence for efficacy of analgesics as monotherapy for neuropathic pain associated with HIV-associated polyneuropathies, in spite of demonstrated efficacy in other neuropathic pain conditions. We evaluated the tolerability and analgesic efficacy of duloxetine, methadone, and the combination of duloxetine-methadone compared with placebo. This study was a phase II, randomized, double-blind, placebo-controlled, four-period crossover multicenter study of analgesic therapy for patients with at least moderate neuropathic pain due to HIV-associated polyneuropathy. Duloxetine, methadone, combination duloxetine-methadone, and placebo were administered in four different possible sequences. The primary outcome measure was mean pain intensity (MPI) measured daily in a study-supplied pain diary. A total of 15 patients were enrolled from eight study sites and eight patients completed the entire trial. Study treatments failed to show statistically significant change in MPI compared with placebo. Adverse events were frequent and associated with high rates of drug discontinuation and study dropout. Challenges with participant recruitment and poor retention precluded trial completion to its planned targets, limiting our evaluation of the analgesic efficacy of the study treatments. Challenges to successful completion of this study and lessons learned are discussed. Wiley Periodicals, Inc.

Experience and challenges presented by a multicenter crossover study of combination analgesic therapy for the treatment of painful HIV-associated polyneuropathies

PubMed Central

Harrison, Taylor; Miyahara, Sachiko; Lee, Anthony; Evans, Scott; Bastow, Barbara; Simpson, David; Gilron, Ian; Dworkin, Robert; Daar, Eric S.; Wieclaw, Linda; Clifford, David B.

2014-01-01

Objective There is limited evidence for efficacy of analgesics as monotherapy for neuropathic pain associated with HIV-associated polyneuropathies, in spite of demonstrated efficacy in other neuropathic pain conditions. We evaluated the tolerability and analgesic efficacy of duloxetine, methadone, and the combination of duloxetine-methadone compared to placebo. Design This study was a phase II, randomized, double blind, placebo-controlled, four-period crossover multi-center study of analgesic therapy for patients with at least moderate neuropathic pain due to HIV-associated polyneuropathy. Duloxetine, methadone, combination duloxetine-methadone, and placebo were administered in four different possible sequences. The primary outcome measure was mean pain intensity (MPI) measured daily in a study-supplied pain diary. Results A total of 15 patients were enrolled from 8 study sites and 8 patients completed the entire trial. Study treatments failed to show statistically significant change in MPI compared to placebo. Adverse events were frequent and associated with high rates of drug discontinuation and study drop-out. Conclusions Challenges with participant recruitment and poor retention precluded trial completion to its planned targets, limiting our evaluation of the analgesic efficacy of the study treatments. Challenges to successful completion of this study and lessons learned are discussed. PMID:23565581

A comparative study evaluating the efficacy of IS_MAP04 with IS900 and IS_MAP02 as a new diagnostic target for the detection of Mycobacterium avium subspecies paratuberculosis from bovine faeces.

PubMed

de Kruijf, Marcel; Govender, Rodney; Yearsley, Dermot; Coffey, Aidan; O'Mahony, Jim

2017-05-01

The aim of this study was to investigate the efficacy of IS_MAP04 as a potential new diagnostic quantitative PCR (qPCR) target for the detection of Mycobacterium avium subspecies paratuberculosis from bovine faeces. IS_MAP04 primers were designed and tested negative against non-MAP strains. The detection limit of IS_MAP04 qPCR was evaluated on different MAP K-10 DNA concentrations and on faecal samples spiked with different MAP K-10 cell dilutions. A collection of 106 faecal samples was analysed and the efficacy of IS_MAP04 was statistically compared with IS900 and IS_MAP02. The detection limits observed for IS_MAP04 and IS900 on MAP DNA was 34 fg and 3.4 fg respectively. The detection limit of MAP from inoculated faecal samples was 10 2 CFU/g for both IS_MAP04 and IS900 targets and a detection limit of 10 2 CFU/g was also achieved with a TaqMan qPCR targeting IS_MAP04. The efficacy of IS_MAP04 to detect positive MAP faecal samples was 83.0% compared to 85.8% and 83.9% for IS900 and IS_MAP02 respectively. Strong kappa agreements were observed between IS_MAP04 and IS900 (κ=0.892) and between IS_MAP04 and IS_MAP02 (κ=0.897). As a new molecular target, IS_MAP04 showed that the detection limit was comparable to IS900 to detect MAP from inoculated faecal material. The MAP detection efficacy of IS_MAP04 from naturally infected faecal samples proved to be relatively comparable to IS_MAP02, but yielded efficacy results slightly less than IS900. Moreover, IS_MAP04 could be of significant value when used in duplex or multiplex qPCR assays. Copyright © 2017 Elsevier B.V. All rights reserved.

Efficacy and safety of brand-risperidone versus similar-risperidone in elderly patients with neuropsychiatric disorders: A retrospective study

PubMed Central

Folquitto, Jefferson Cunha; de Barros, Sérgio Barbosa; Pinto Junior, Jony Arrais; Bottino, Cássio M.C.

2010-01-01

To compare the efficacy and tolerability of brand-risperidone against similar-risperidone in elderly outpatients. Method The medical files of 16 elderly outpatients from the IPq-HCFMUSP treated with two formulations of risperidone (brand and similar) between July/1999 and February/2000 were reviewed. Two independent raters, using the Clinical Global Impression scale, evaluated the efficacy of the treatment with risperidone and the frequency of adverse effects. Results Comparing October/1999 to November/1999, Rater 1 observed a trend (p=0.059) and Rater 2 found a statistically significant difference, in favor of the brand-risperidone group (p=0.014). Comparing October/1999 to February/2000, Rater 1 observed no statistically significant difference (p=0.190), but the Rater 2 found a statistically significant difference in favor of the brand-risperidone group (p=0.029). Comparing November/1999 to February/2000, both raters found no statistically significant differences between both risperidone formulations. Regarding adverse effects, a statistically significant difference (p=0.046) was found in favor of the patients treated with brand-risperidone. Conclusions The risperidone-reference, compared to similar-risperidone, showed a trend toward greater efficacy and tolerability. PMID:29213664

Cultural differences in the understanding of modelling and feedback as sources of self-efficacy information.

PubMed

Ahn, Hyun Seon; Usher, Ellen L; Butz, Amanda; Bong, Mimi

2016-03-01

The potential role of culture in the development and operation of self-efficacy has been acknowledged by researchers. Clearer understanding of this cultural impact will benefit from research that shows how the same efficacy information is evaluated across cultures. We tested whether two sources of self-efficacy information delivered by multiple social agents (i.e., vicarious experience and social persuasion) were weighed differently by adolescents in different cultures. Of 2,893 middle school students in Korea (n = 416), the Philippines (n = 522), and the United States (n = 1,955) who completed the survey, 400 students were randomly pooled from each country. Invariance of the measurement and of the latent means for self-efficacy and self-efficacy sources across the groups was tested by multigroup confirmatory factor analysis. Predictive utility of the self-efficacy sources was compared by multigroup structural equation modelling. Compared to the students in the two collectivistic countries, the US students reported significantly higher mathematics self-efficacy. Whereas the efficacy beliefs of the Korean and the US students were predicted equally well by the vicarious experience from their teachers and the social persuasion by their family and peers, those of the Filipino adolescents were best predicted by the social persuasion from their peers. This study provided empirical evidence that socially conveyed sources of self-efficacy information are construed and evaluated differently across cultures, depending on who delivered the efficacy-relevant information. © 2015 The British Psychological Society.

Meta-analysis using individual patient data: efficacy and durability of topical alicaforsen for the treatment of active ulcerative colitis.

PubMed

Vegter, S; Tolley, K; Wilson Waterworth, T; Jones, H; Jones, S; Jewell, D

2013-08-01

The antisense ICAM-1 inhibitor alicaforsen has been studied in four phase 2 studies in ulcerative colitis (UC). Recruited patients varied as to the extent of their colitis and in the severity of disease at entry. To investigate the efficacy of alicaforsen enema in specific UC populations. Efficacy was analysed for short-term (week 6-10) and long-term (week 30) outcomes compared with either placebo or a high-dose mesalazine (mesalamine) enema in patients with disease extent up to 40 cm from the anal verge in patients with moderate or severe disease, and in patients with both of these features. Individual patient data meta-analyses of 200 patients from four phase 2 studies evaluating nightly alicaforsen 240 mg enema and comparators. Patient data were pooled and analysed in a single data set. Continuous outcomes were evaluated using anova; dichotomous outcomes were evaluated using Pearson chi-square or Fisher's exact tests. Alicaforsen showed superior efficacy vs. placebo in: patients with disease extent up to 40 cm, patients with moderate and severe disease and especially when both those conditions were satisfied. In these patient groups, mesalazine also showed short-term efficacy. At week 30, however, the efficacy of mesalazine waned and alicaforsen became significantly more efficacious. This post hoc meta-analysis showed that alicaforsen is effective in patients with active UC, especially in patients with distal disease, which is of moderate/severe activity. The efficacy of alicaforsen was durable in these sub-groups, suggesting a disease-modifying effect. This analysis suggests that alicaforsen enema may offer an effective, potentially durable response in moderate/severe distal active UC. © 2013 John Wiley & Sons Ltd.

Superintendent Efficacy Investigation of a Six-Component Leadership Framework for Developing Effective Learning Environments

ERIC Educational Resources Information Center

Devono, Frank D.

2009-01-01

This study, using the "Superintendent Efficacy Questionnaire" (Devono, Diaz & Callejo Perez, 2008), compared 413 West Virginian K-12 superintendents', principals' and teachers' perceptions of 6 superintendent leadership components: staff development administration, communication of mission, curriculum/instruction expertise,…

Systematic Review with Network Meta-Analysis: Comparative Efficacy of Biologics in the Treatment of Moderately to Severely Active Ulcerative Colitis

PubMed Central

Vickers, Adrian D.; Ainsworth, Claire; Mody, Reema; Bergman, Annika; Ling, Caroline S.; Medjedovic, Jasmina; Smyth, Michael

2016-01-01

Background Biological therapies are increasingly used to treat ulcerative colitis (UC). Aim To compare the efficacy of biologics in adults with moderately-to-severely active UC, stratified by prior exposure to anti-tumour necrosis factor (anti-TNF) therapy. Methods A systematic literature review was undertaken to identify studies of biologics approved for UC. Network meta-analysis was conducted for endpoints at induction and maintenance. Results Seven studies were included in the meta-analysis of induction treatment for anti-TNF therapy-naïve patients. All biologics were more effective than placebo in inducing clinical response, clinical remission, and mucosal healing. Infliximab demonstrated a statistically significant improvement over adalimumab in clinical response (odds ratio [OR] [95% credible interval (CrI)]: 2.19 [1.35–3.55]), clinical remission (OR [95% CrI]: 2.81 [1.49–5.49]), and mucosal healing (OR [95% CrI]: 2.23 [1.21–4.14]); there were no other significant differences between biologics for induction efficacy. Five studies were included in the meta-analysis of maintenance treatment, two studies rerandomised responder patients at end of induction, and three followed the same patients ‘straight through’. To account for design differences, the number of responders at end of induction was assumed to be equivalent to the number rerandomised. Vedolizumab showed significantly different durable clinical response from comparators (OR [95% CrI] infliximab 3.18 [1.14–9.20], golimumab 2.33 [1.04–5.41], and adalimumab 3.96 [1.67–9.84]). In anti-TNF therapy-experienced patients, only vedolizumab and adalimumab could be compared. At induction, no significant differences in efficacy were seen. During maintenance, vedolizumab showed significantly improved rates of mucosal healing versus adalimumab (OR [95% CrI]: 6.72 [1.36–41.0]). Conclusions This study expands the understanding of comparative efficacies of biologic treatments for UC, encompassing outcomes and populations not previously studied. All biologic treatments were effective for UC during induction. Vedolizumab demonstrated possible clinical benefits in the maintenance setting versus all comparators, irrespective of prior anti-TNF exposure and after adjusting for differences in study design. PMID:27776175

Lipopolysaccharide based oral nanocarriers for the improvement of bioavailability and anticancer efficacy of curcumin.

PubMed

Chaurasia, Sundeep; Patel, Ravi R; Chaubey, Pramila; Kumar, Nagendra; Khan, Gayasuddin; Mishra, Brahmeshwar

2015-10-05

Soluthin MD(®), a unique phosphatidylcholine-maltodextrin based hydrophilic lipopolysaccharide, which exhibits superior biocompatibility and bioavailability enhancer properties for poorly water soluble drug(s). Curcumin (CUR) is a potential natural anticancer drug with low bioavailability due to poor aqueous solubility. The study aims at formulation and optimization of CUR loaded lipopolysaccharide nanocarriers (C-LPNCs) to enhance oral bioavailability and anticancer efficacy in colon-26 tumor-bearing mice in vitro and in vivo. The Optimized C-LPNCs demonstrated favorable mean particle size (108 ± 3.4 nm) and percent entrapment efficiency (65.29 ± 1.0%). Pharmacokinetic parameters revealed ∼130-fold increase in oral bioavailability and cytotoxicity studies demonstrated ∼23-fold reduction in 50% cell growth inhibition when treated with optimized C-LPNCs as compared to pure CUR. In vivo anticancer study performed with optimized C-LPNCs showed significant increase in efficacy compared with pure CUR. Thus, lipopolysaccharide nanocarriers show potential delivery strategy to improve oral bioavailability and anticancer efficacy of CUR in the treatment of colorectal cancer. Copyright © 2015 Elsevier Ltd. All rights reserved.

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis.

PubMed

Manguso, Francesco; Bennato, Raffaele; Lombardi, Giovanni; Riccio, Elisabetta; Costantino, Giuseppe; Fries, Walter

2016-01-01

We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23-2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03-1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00-2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76-2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24-1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44-1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.

Associations Between Self-Efficacy and Secondary Health Conditions in People Living With Spinal Cord Injury: A Systematic Review and Meta-Analysis.

PubMed

van Diemen, Tijn; Crul, Tim; van Nes, Ilse; Geertzen, Jan H; Post, Marcel W

2017-12-01

To describe the association between self-efficacy and secondary health conditions (SHCs) in people living with spinal cord injury (SCI). PubMed, EMBASE, the Cochrane Library, and CINAHL were systematically searched from database inception to September 2016. Studies describing patients living with SCI in which self-efficacy was measured by a standardized questionnaire and an association was made with somatic or psychological SHCs. An independent extraction by multiple observers was performed based on the Strengthening the Reporting of Observational Studies in Epidemiology statements checklist. A meta-analysis concerning the association between self-efficacy and SHCs in people with SCI was performed if a minimum of 4 comparable studies were available. Of 670 unique articles screened, 22 met the inclusion criteria. Seven of these 22 studies investigated associations between self-efficacy and somatic SHCs. Only a trend toward an association between higher self-efficacy and less pain, fatigue, number of SHCs, and limitations caused by SHCs was found. Twenty-one studies described the association between self-efficacy and psychological SHCs. All correlations of higher self-efficacy with fewer depressive (18 studies) and anxiety symptoms (7 studies) were significant, and meta-analysis showed a strong negative correlation of -.536 (-.584 to -.484) and -.493 (-.577 to -.399), respectively. A small number of studies (2) showed a trend toward a positive correlation between self-efficacy and quality of life. Self-efficacy is negatively associated with depressive and anxiety symptoms in SCI. Therefore, self-efficacy seems an important target in the rehabilitation of patients living with SCI. More research is necessary to clarify the associations between self-efficacy and somatic SHCs. Future research should also focus on different types of self-efficacy and their association with SHCs. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Ethinyl estradiol and levonorgestrel in a transdermal contraceptive delivery system.

PubMed

Sriprasert, Intira; Stanczyk, Frank Z; Archer, David F

2015-01-01

The new transdermal contraceptive delivery system (TCDS) developed by Agile Therapeutics containing ethinyl estradiol and levonorgestrel (EE/LNG) is a reversible contraceptive method that maintains stable serum levels of both estrogen and progestin, and has efficacy similar to that of combination oral contraceptives (COC). We provided information of this new TCDS compared with the only TCDS available on the market that contains EE and norelgestromin, and has a higher EE exposure than a COC with 35 µg of EE potentially increasing the risk of venous thromboembolism. The article will summarize finding from clinical studies Phase I, II and III of EE/LNG TCDS. The development of the lower dose EE/LNG TCDS has demonstrated less EE exposure. The serum levels of EE and LNG were stable and comparable between various application sites and daily life conditions. Moreover, the EE/LNG TCDS showed comparable efficacy among obese and non-obese users. However, the Pearl index of this EE/LNG TCDS is questionable and the problem of compliance is a potential confounder of the results. The current Phase III efficacy study will contribute to a further evaluation of compliance and efficacy and will be completed in 2016.

Examination of Self-Efficacy and Burnout Dynamics of Preschool Teachers in Turkey and the United States

ERIC Educational Resources Information Center

Orçan, Maide

2013-01-01

This study aimed to comparatively examine the self-efficacy and burnout levels of preschool teachers in Turkey and the United States. Of the general screening models, the study uses the relational screening model. A total of 90 teachers participated in the study. 32 of the participants were from the United States and 58 were from Turkey. The…

Effect of self-efficacy and social support on adherence to antihypertensive drugs.

PubMed

Criswell, Thomas J; Weber, Cynthia A; Xu, Yinghui; Carter, Barry L

2010-05-01

To determine the relationship between poor adherence and self-efficacy or social support after a pharmacist intervention. Post-hoc analysis of data from two randomized controlled trials of physician-pharmacist collaborative interventions (6 and 9 mo, respectively) to improve blood pressure control. Eleven university-affiliated primary care clinics. Five hundred eighty-four patients (aged 21-85 yrs) with uncontrolled primary hypertension; 296 were in the intervention group and 288 were in the control group. Pharmacists provided intensified hypertension management and drug adherence counseling to patients in the intervention group. Social support and self-efficacy questionnaires were administered at baseline and end-of-study visits. Patient adherence was monitored by using the Morisky self-reported adherence questionnaire. Self-reported adherence scores improved significantly in the control group (p=0.0053) but not in the intervention group; however, adherence at baseline in both groups was high. There were small, but significant, improvements in self-efficacy (p<0.04) and social support (p<0.05) scores in the intervention group but not the control group at the end of the study. Social support and, to a lesser extent, self-efficacy improved as a function of duration of study participation (9-mo vs 6-mo intervention), regardless of whether the patient received the intervention. Blood pressure control in both groups improved significantly at the end of the study; however, mean blood pressure was significantly lower in the intervention group (129.7/76.6 mm Hg) compared with the control group (140.8/78.9 mm Hg; p<0.0001 for systolic, p=0.032 for diastolic). Social support and self-efficacy improved significantly in the intervention group at the end of the pharmacist intervention. Drug adherence was correlated with self-efficacy even though drug adherence did not improve significantly in the intervention group. The fact that social support and self-efficacy improved as a function of duration of study participation suggests that participation in a research study may have had a positive influence on these measures. Even though the changes in social support, self-efficacy, and drug adherence were modest, there was significantly better blood pressure control in the intervention group compared with the control group. These findings indicate that changes in drug adherence, self-efficacy, or social support probably played a minor role in the blood pressure outcomes in these studies.

Iron-Magnesium Hydroxycarbonate (Fermagate): A Novel Non-Calcium-Containing Phosphate Binder for the Treatment of Hyperphosphatemia in Chronic Hemodialysis Patients

PubMed Central

McIntyre, Christopher W.; Pai, Pearl; Warwick, Graham; Wilkie, Martin; Toft, Alex J.; Hutchison, Alastair J.

2009-01-01

Background and objectives: This phase II study tested the safety and efficacy of fermagate, a calcium-free iron and magnesium hydroxycarbonate binder, for treating hyperphosphatemia in hemodialysis patients. Design, setting, participants, & measurements: A randomized, double-blind, three-arm, parallel-group study compared two doses of fermagate (1 g three times daily or 2 g three times daily with placebo). Sixty-three patients who had been on a stable hemodialysis regimen for ≥3 mo were randomized to the treatment phase. Study medication was administered three times daily just before meals for 21 d. The primary endpoint was reduction in serum phosphate over this period. Results: In the intention-to-treat analysis, mean baseline serum phosphate was 2.16 mmol/L. The fermagate 1- and 2-g three-times-daily treatment arms were associated with statistical reductions in mean serum phosphate to 1.71 and 1.47 mmol/L, respectively. Adverse event (AE) incidence in the 1-g fermagate arm was statistically comparable to the placebo group. The 2-g arm was associated with a statistically higher number of patients reporting AEs than the 1-g arm, particularly gastrointestinal AEs, as well as a higher number of discontinuations, complicating interpretation of this dose's efficacy. Both doses were associated with elevations of prehemodialysis serum magnesium levels. Conclusions: The efficacy and tolerability of fermagate were dose dependent. Fermagate showed promising efficacy in the treatment of hyperphosphatemia in chronic hemodialysis patients as compared with placebo in this initial phase II study. The optimal balance between efficacy and tolerability needs to be determined from future dose-titration studies, or fixed-dose comparisons of more doses. PMID:19158369

Efficacy of hormone therapy with and without methyltestosterone augmentation of venlafaxine in the treatment of postmenopausal depression: a double-blind controlled pilot study.

PubMed

Dias, Rodrigo S; Kerr-Corrêa, Florence; Moreno, Ricardo A; Trinca, Luzia A; Pontes, Anagloria; Halbe, Hans W; Gianfaldoni, Arlete; Dalben, Ivete S

2006-01-01

This study evaluated the augmentation of venlafaxine with hormone therapy in the treatment of postmenopausal depression. The hormones evaluated were estrogen (0.625 mg) in combination with medroxyprogesterone acetate (2.5 mg) and methyltestosterone (2.5 mg). Seventy-two menopausal women (mean age: 53.6 +/- 4.27 years) diagnosed with depression (Montgomery-Asberg Depression Rating Scale [MADRS] scores > or = 20) were treated with venlafaxine and one of the following hormone therapy combinations, in a double-blind regimen: estrogen + medroxyprogesterone + methyltestosterone (group 1, n = 20); estrogen + medroxyprogesterone acetate (group 2, n = 20); methyltestosterone only (group 3, n = 16); and no hormone therapy (group 4, n = 16). Study duration was 24 weeks. Primary efficacy outcome was remission according to the MADRS, whereas secondary efficacy measures included the Clinical Global Impression (CGI), Blatt-Kupperman Index, and Women's Health Questionnaire (WHQ). Forty-eight patients completed the study. All groups showed significant improvement from baseline. Group 3 demonstrated significant improvement on the MADRS compared with placebo (group 4) at weeks 20 (P = 0.048) and 24 (P = 0.030); effect size 8.04 (0.83; 15.26) (P = 0.029), but also had the highest dropout rate. Groups 1 and 3 had significant CGI improvement rates compared with placebo: 42.23% (P = 0.012) and 44.45% (P = 0.08), respectively. There were no differences in the WHQ or BKI scores among the groups. Methyltestosterone 2.5 mg had the highest effect size compared with placebo, but the high dropout rate prevented its efficacy from being determined. Estrogen plus medroxyprogesterone, combined with methyltestosterone or otherwise, demonstrated a trend toward increased efficacy of venlafaxine. Further larger-scale clinical trials are needed to elucidate the findings of this pilot study.

Safety and efficacy of conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: randomized controlled trial in adult renal transplantation.

PubMed

Oh, Chang-Kwon; Huh, Kyu Ha; Lee, Jong Soo; Cho, Hong Rae; Kim, Yu Seun

2014-09-01

The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction. This prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation, while patients in the control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfaction for the two drugs at 6 months post-transplantation were compared. Sixty patients were enrolled and randomized to the investigational group (28 of 29 patients completed the study) or the control group (26 of 31 patients completed the study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and control groups were 0% and 10.7%, respectively; patient survival was 100% in each group. No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation (p=0.97). The safety and satisfaction profile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35). Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.

An in vivo comparison of antimicrobial efficacy of sodium hypochlorite and Biopure MTAD™ against enterococcus faecalis in primary teeth: A qPCR study.

PubMed

Tulsani, S G; Chikkanarasaiah, N; Bethur, S

2014-01-01

Biopure MTAD™, a new root canal irrigant has shown promising results against the most common resistant microorganism, E. faecalis, in permanent teeth. However, there is lack of studies comparing its antimicrobial effectiveness with NaOCl in primary teeth. The purpose of this study was to compare the in vivo antimicrobial efficacy of NaOCl 2.5% and Biopure MTAD™ against E. faecalis in primary teeth. Forty non vital single rooted primary maxillary anterior teeth of children aged 4-8 years, were irrigated either with NaOCl 2.5% (n=15), Biopure MTAD™ (n=15) and 0.9% Saline (n=10, control group). Paper point samples were collected at baseline (S1) and after chemomechanical preparation (S2) during the pulpectomy procedure. The presence of E. faecalis in S1 & S2 was evaluated using Real time Polymerase Chain Reaction. Statistical significant difference was found in the antimicrobial efficacy of NaOCl 2.5 % and BioPure MTAD™ when compared to saline (p>0.05). However, no statistical significant difference was found between the efficacies of both the irrigants. NaOCl 2.5% and BioPure MTAD™, both irrigants are equally efficient against E. faecalis in necrotic primary anterior teeth. MTAD is a promising irrigant, however clinical studies are required to establish it as ideal root canal irrigant in clinical practice.

Self-Control Strength Depletion Reduces Self-Efficacy and Impairs Exercise Performance.

PubMed

Graham, Jeffrey D; Bray, Steven R

2015-10-01

The purpose of this study was to investigate the role of task self-efficacy as a psychological factor involved in the relationship between self-control depletion and physical endurance. Participants (N = 37) completed two isometric handgrip endurance trials, separated by a Stroop task, which was either congruent (control) or incongruent (causing depletion). Task self-efficacy for the second endurance trial was measured following the Stroop task. Participants in the depletion condition reported lower task self-efficacy and showed a greater reduction in performance on the second endurance trial when compared with controls. Task self-efficacy also mediated the relationship between self-control depletion and endurance performance. The results of this study provide evidence that task self-efficacy is negatively affected following self-control depletion. We recommend that task self-efficacy be further investigated as a psychological factor accounting for the negative change in self-control performance of physical endurance and sport tasks following self-control strength depletion.

A comparison of the efficacy of new asymmetric bispyridinium oximes (K027, K048) with currently available oximes against tabun by in vivo methods.

PubMed

Kassa, Jiri; Kuca, Kamil; Cabal, Jiri; Paar, Martin

2006-10-01

The potency of newly developed asymmetric bispyridinium oximes (K027, K048) in reactivating tabun-inhibited acetylcholinesterase (AChE) and in eliminating tabun-induced acute toxic effects was compared with commonly used oximes (obidoxime, trimedoxime, the oxime HI-6) using in vivo methods. Studies determined the percent of reactivation of tabun-inhibited blood and tissue AChE in poisoned rats and showed that the reactivating efficacy of both newly developed oximes is comparable with obidoxime and trimedoxime, the most efficacious known reactivators of tabun-inhibited AChE. These were also found to be sufficiently efficacious in the elimination of acute lethal toxic effects in tabun-poisoned rats. The oxime HI-6, relatively efficacious against soman, did not seem to be an adequately effective oxime in reactivation of tabun-inhibited AChE and in counteracting acute lethal effects of tabun. In addition, our results confirm that the efficacy of oximes in reactivating tabun-inhibited AChE in blood, diaphragm, and brain correlates with the potency of oximes in protecting rats poisoned with supralethal doses of tabun.

Effects of dosage and dosing frequency on the efficacy and safety of high-dose metformin in Japanese patients with type 2 diabetes mellitus.

PubMed

Kanto, Kousei; Ito, Hiroyuki; Noso, Shinsuke; Babaya, Naru; Hiromine, Yoshihisa; Taketomo, Yasunori; Toma, Junko; Niwano, Fumimaru; Yasutake, Sara; Kawabata, Yumiko; Ikegami, Hiroshi

2017-09-30

Differences in the efficacy and safety of antidiabetic drugs among different ethnic groups are well documented. Metformin is widely used in the treatment of type 2 diabetes in Western countries, but high doses of metformin have been approved only recently for clinical use in Japan. The aim of the present study was to investigate the effects of dosage and dosing frequency on the efficacy and safety of high-dose metformin in Japanese patients. A total of 71 Japanese patients with type 2 diabetes were prospectively studied for the effects of dosage and dosing frequency on the efficacy and safety of metformin during hospitalization. Dose effects were studied in 27 patients treated with 0, 500, 1,000, 1,500 and 2,250 mg/day of metformin. The effect of dosing frequency was compared in 56 patients with 1,500 mg/day of metformin administered either two or three times per day. Significant dose-dependent improvement in daily profiles of blood glucose was observed with metformin dosages up to 1,500 mg/day, with a trend towards further improvement observed at 2,250 mg/day. The efficacy of 1,500 mg of metformin was comparable when the drug was administered either two or three times per day. The most frequently reported side-effects were gastrointestinal symptoms, which were not affected by the dosage or dosing frequency of metformin. These results show that the efficacy of high-dose metformin is dose-dependent in Japanese patients. The efficacy and safety of metformin were similar when the drug was administered either two or three times per day. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Studies of certain sulfonamide drugs for use in juvenile chinook salmon

USGS Publications Warehouse

Amend, D.F.; Fryer, J.L.; Pilcher, K.S.

1969-01-01

In the work described in this paper, the efficacies of sulfisoxazole and sulfadimethoxine were compared to the efficacy of sulfamethazine. Experiments were designed to determine the rate of intestinal absorption, the rate of elimination from the blood, the effect on growth, and the toxicity of each drug in juvenile chinook salmon (Oncorhynchus tshawytscha). The comparative bacteriostatic activity against two common fish pathogens was also determined for each drug. 

Visual presentations of efficacy data in direct-to-consumer prescription drug print and television advertisements: A randomized study.

PubMed

Sullivan, Helen W; O'Donoghue, Amie C; Aikin, Kathryn J; Chowdhury, Dhuly; Moultrie, Rebecca R; Rupert, Douglas J

2016-05-01

To determine whether visual aids help people recall quantitative efficacy information in direct-to-consumer (DTC) prescription drug advertisements, and if so, which types of visual aids are most helpful. Individuals diagnosed with high cholesterol (n=2504) were randomized to view a fictional DTC print or television advertisement with no visual aid or one of four visual aids (pie chart, bar chart, table, or pictograph) depicting drug efficacy. We measured drug efficacy and risk recall, drug perceptions and attitudes, and behavioral intentions. For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph and the table was better than the pie chart. For television advertisements, any visual aid, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph or the table. Visual aids depicting quantitative efficacy information in DTC print and television advertisements increased drug efficacy recall, which may help people make informed decisions about prescription drugs. Adding visual aids to DTC advertising may increase the public's knowledge of how well prescription drugs work. Published by Elsevier Ireland Ltd.

Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study.

PubMed

Lee, Saridpong; Tanglertsampan, Chuchai; Tanchotikul, Mingkwan; Worapunpong, Nigun

2014-02-01

Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side-effects were also evaluated. Thirty-nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side-effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis. © 2014 Japanese Dermatological Association.

Efficacy and safety of rasagiline as an adjunct to levodopa treatment in Chinese patients with Parkinson's disease: a randomized, double-blind, parallel-controlled, multi-centre trial.

PubMed

Zhang, Lina; Zhang, Zhiqin; Chen, Yangmei; Qin, Xinyue; Zhou, Huadong; Zhang, Chaodong; Sun, Hongbin; Tang, Ronghua; Zheng, Jinou; Yi, Lin; Deng, Liying; Li, Jinfang

2013-08-01

Rasagiline mesylate is a highly potent, selective and irreversible monoamine oxidase type B (MAOB) inhibitor and is effective as monotherapy or adjunct to levodopa for patients with Parkinson's disease (PD). However, few studies have evaluated the efficacy and safety of rasagiline in the Chinese population. This study was designed to investigate the safety and efficacy of rasagiline as adjunctive therapy to levodopa treatment in Chinese PD patients. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial conducted over a 12-wk period that enrolled 244 PD patients with motor fluctuations. Participants were randomly assigned to oral rasagiline mesylate (1 mg) or placebo, once daily. Altogether, 219 patients completed the trial. Rasagiline showed significantly greater efficacy compared with placebo. During the treatment period, the primary efficacy variable--mean adjusted total daily off time--decreased from baseline by 1.7 h in patients treated with 1.0 mg/d rasagiline compared to placebo (p < 0.05). Scores using the Unified Parkinson's Disease Rating Scale also improved during rasagiline treatment. Rasagiline was well tolerated. This study demonstrated that rasagiline mesylate is effective and well tolerated as an adjunct to levodopa treatment in Chinese PD patients with fluctuations.

Surgeons' and trainees' perceived self-efficacy in operating theatre non-technical skills.

PubMed

Pena, G; Altree, M; Field, J; Thomas, M J W; Hewett, P; Babidge, W; Maddern, G J

2015-05-01

An important factor that may influence an individual's performance is self-efficacy, a personal judgement of capability to perform a particular task successfully. This prospective study explored newly qualified surgeons' and surgical trainees' self-efficacy in non-technical skills compared with their non-technical skills performance in simulated scenarios. Participants undertook surgical scenarios challenging non-technical skills in two simulation sessions 6 weeks apart. Some participants attended a non-technical skills workshop between sessions. Participants completed pretraining and post-training surveys about their perceived self-efficacy in non-technical skills, which were analysed and compared with their performance in surgical scenarios in two simulation sessions. Change in performance between sessions was compared with any change in participants' perceived self-efficacy. There were 40 participants in all, 17 of whom attended the non-technical skills workshop. There was no significant difference in participants' self-efficacy regarding non-technical skills from the pretraining to the post-training survey. However, there was a tendency for participants with the highest reported self-efficacy to adjust their score downwards after training and for participants with the lowest self-efficacy to adjust their score upwards. Although there was significant improvement in non-technical skills performance from the first to second simulation sessions, a correlation between participants' self-efficacy and performance in scenarios in any of the comparisons was not found. The results suggest that new surgeons and surgical trainees have poor insight into their non-technical skills. Although it was not possible to correlate participants' self-belief in their abilities directly with their performance in a simulation, in general they became more critical in appraisal of their abilities as a result of the intervention. © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd.

52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis

PubMed Central

Emery, Paul; Vencovský, Jiří; Sylwestrzak, Anna; Leszczyński, Piotr; Porawska, Wieslawa; Baranauskaite, Asta; Tseluyko, Vira; Zhdan, Vyacheslav M.; Stasiuk, Barbara; Milasiene, Roma; Barrera Rodriguez, Aaron Alejandro; Cheong, Soo Yeon; Ghil, Jeehoon

2017-01-01

Abstract Objective To compare the 52-week efficacy and safety of SB4 [an etanercept biosimilar] with reference etanercept (ETN) in patients with active RA. Methods In a phase 3, randomized, double-blind, multicentre study, patients with moderate to severe RA despite MTX treatment were randomized to receive 50 mg/week of s.c. SB4 or ETN up to week 52. Efficacy assessments included ACR response rates, 28-joint DAS, Simplified and Clinical Disease Activity Indices and changes in the modified total Sharp score (mTSS). Safety and immunogenicity were also evaluated. Results A total of 596 patients were randomized to receive either SB4 (n = 299) or ETN (n = 297) and 505 (84.7%) patients completed 52 weeks of the study. At week 52, the ACR20 response rates in the per-protocol set were comparable between SB4 (80.8%) and ETN (81.5%). All efficacy results were comparable between the two groups and they were maintained up to week 52. Radiographic progression was also comparable and the change from baseline in the mTSS was 0.45 for SB4 and 0.74 for ETN. The safety profile of SB4 was similar to that of ETN and the incidence of anti-drug antibody development up to week 52 was 1.0 and 13.2% in the SB4 and ETN groups, respectively. Conclusion Efficacy including radiographic progression was comparable between SB4 and ETN up to week 52. SB4 was well tolerated and had a similar safety profile to that of ETN. Trial registration number ClinicalTrials.gov NCT01895309, EudraCT 2012-005026-30 PMID:28968793

Comparative speed of efficacy against Ctenocephalides felis of two oral treatments for dogs containing either afoxolaner or fluralaner.

PubMed

Beugnet, Frederic; Liebenberg, Julian; Halos, Lenaïg

2015-01-30

A study was designed to compare the efficacy of NexGard(®) and Bravecto™, 2 recently introduced oral ectoparasiticides containing isoxazolines, against fleas (Ctenocephalides felis) on dogs. Twenty-four healthy dogs, weighing 9.2 kg to 28.6 kg, were included in this parallel group design, randomized, and controlled efficacy study. On Day -1, the 24 dogs were allocated to 3 study groups: untreated control; Nexgard(®) treated and Bravecto™ treated. The treatments were administered on Days 0, 28 and 56 for Nexgard(®) (labelled for monthly administration), and once on Day 0 for Bravecto™ (labelled for a 12 week use). Flea infestations were performed weekly with 100 adult unfed C. felis on each dog from Days 42 to 84. Fleas were counted and re-applied at 6 and 12 h post-infestation and removed and counted 24 h post-infestation. The arithmetic mean flea count for the untreated group ranged from 62.9 to 77.6 at 24 h post-infestation, indicating vigorous flea challenges on all assessment days. Both the Nexgard(®) and Bravecto™ treated groups had statistically significantly (p<0.05) less fleas compared to the untreated group on all assessment time points and days. Significantly fewer fleas were recorded for NexGard(®) treated dogs compared to Bravecto™ treated dogs at 6 h post-infestation on Day 56, 63, 70, 77 and 84 and at 12 h post-infestation on Days 70 and 84. No statistically significant (p<0.05) differences were recorded between the treated groups at 24 h post-infestation. Efficacies recorded 6 h post-infestation for Nexgard(®) ranged from 62.8% (Day 49) to 97.3% (Day 56), and efficacies ranged from 94.1% (Day 49) to 100% (Days 42, 56, 70 and 84) at 12 h post-infestation. Efficacies recorded for Bravecto™ ranged from 45.1% (Day 84) to 97.8% (Day 42) at 6 h post-infestation, and from 64.7% (Day 84) to 100% (Days 42 and 56) at 12 h post-infestation. Efficacies observed at 24 h were 100% for both products during the study except 99.6% on Day 84 for Bravecto™. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

Comparative study of therapeutic response to baclofen vs tolperisone in spasticity.

PubMed

Agarwal, Saurabh; Patel, Tejas; Shah, Nehal; Patel, Bhoomika M

2017-03-01

Spasticity from the upper motor neuron syndrome can result from a variety of conditions affecting the cortex or spinal cord. Some of the more common conditions associated with spasticity include spinal cord injury, cerebral palsy, and post-stroke syndrome. In this study we compared the efficacy and safety of baclofen vs tolperisone in spasticity. One hundred fifty patients with cerebral palsy or post stroke or spinal cord injury associated spasticity were enrolled in present study. Group I comprised of Seventy-five patients receiving baclofen and group II comprised of 75 patients receiving tolperisone. For efficacy measurement 4 evaluation methods were used, 1) Modified Ashworth Scale for muscle tone, 2) Medical research council scale for muscle strength and 3) Barthel Index for functional outcome 4) Coefficient of efficacy. In efficacy evaluation, both groups showed significant improvement in muscle tone, muscle strength and functional outcome at week 6 (Group I, 1.55±0.053, 2.79+0.032, 59.31±1.32; Group II, 1.57±0.053, 3.04±0.032, 73±1.32 respectively). In between the group analysis, there was no significant difference in muscle tone improvement in both the groups after 6 weeks (Group I, 1.055±0.053 vs Group II, 1.57±0.053, p>0.05). Group II showed non-significant but greater improvement in muscle strength (Week 6; Group I, 2.79±0.032 vs Group II, 3.04±0.032, p>0.07). Improvement in functional outcomes was greater in group II as compared to group I (Group I, 59.31±1.32 vs Group II, 73±1.32, p<0.05). Overall efficacy coefficient was greater for group II (3.6) as compared to group I (2.3). Baclofen showed more side effects compared to tolperisone in, asthenia being the most frequent. Tolperisone offers greater improvement in activities of daily living compared to baclofen. Tolperisone is more tolerable drug as compared to baclofen. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

The IPSO study: ibuprofen, paracetamol study in osteoarthritis. A randomised comparative clinical study comparing the efficacy and safety of ibuprofen and paracetamol analgesic treatment of osteoarthritis of the knee or hip

PubMed Central

Boureau, F; Schneid, H; Zeghari, N; Wall, R; Bourgeois, P

2004-01-01

Objective: To compare the analgesic efficacy of single and multiple doses of ibuprofen with that of paracetamol in patients with knee or hip osteoarthritis (IPSO study). Method: 222 patients were randomised in a double blind, multicentre study—156 (70%) had a painful knee joint and 66 (30%) a painful hip joint. The main efficacy criterion was pain intensity assessment after a single dose (ibuprofen 400 mg, paracetamol 1000 mg). Functional disability assessment and patient global assessment were carried out over 14 days. Results: The sum of the pain intensity difference over 6 hours after the first administration was significantly higher (p = 0.046) in the ibuprofen group than in the paracetamol group. Over 14 days pain intensity decreased from the first day and was significantly lower in the ibuprofen group than in the paracetamol group (p<0.05). The functional disability of the patient was assessed using the WOMAC; the ibuprofen group improved significantly over 2 weeks compared with the paracetamol group for each of the subscales: stiffness (p<0.002), pain (p<0.001), physical function (p<0.002). The drugs were equally safe. Conclusion: The IPSO study shows that for the treatment of osteoarthritic pain, ibuprofen 400 mg at a single and multiple dose (1200 mg/day) for 14 days is more effective than paracetamol, either as a single dose of 1000 mg or a multiple dose (3000 mg/day). Because ibuprofen and paracetamol have similar tolerability, this study indicates that the efficacy/tolerability ratio of ibuprofen is better than that of paracetamol in this indication over 14 days. PMID:15308513

Effect of the dedicated education unit on nursing student self-efficacy: A quasi-experimental research study.

PubMed

George, Lynn E; Locasto, Lisa W; Pyo, Katrina A; W Cline, Thomas

2017-03-01

Although the Dedicated Education Unit (DEU) has shown initial promise related to satisfaction with the teaching/learning environment, few studies have examined student outcomes related to the use of the DEU as a clinical education model beyond student satisfaction. The purpose of this quantitative, quasi-experimental study was to compare student outcomes from the traditional clinical education (TCE) model with those from the DEU model. Participants were students enrolled in a four-year baccalaureate program in nursing (n = 193) who had clinical education activities in one of three clinical agencies. Participants were assigned to either the DEU or a TCE model. Pre-clinical and post-clinical self-efficacy scores were measured for each group using an adapted Generalized Self-Efficacy Scale (Schwarzer and Jerusalem, 1995). Both groups experienced a significant increase in self-efficacy scores post clinical education. The increase in self-efficacy for the DEU students was significantly greater than the increase in self-efficacy for the traditional students. Self-efficacy is considered an important outcome of nursing education because high self-efficacy has been linked to making an easier transition from student to nursing professional. This study supports the quality of the DEU as a clinical education model by examining student self-efficacy outcomes. Copyright © 2017 Elsevier Ltd. All rights reserved.

Diagnostic efficacy of in vitro methods vs. skin testing in patients with inhalant allergies

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

Corey, J.P.; Liudahl, J.J.; Young, S.A.

1991-03-01

The purpose of our study was to investigate the diagnostic efficacy of two selected methods of in vitro allergy testing. Specifically, the PRIST/modified RAST I125 isotope systems and the Quantizyme/modified EAST alkaline phosphatase method were compared. The time, expense, convenience, and diagnostic efficacy of the two procedures are discussed. Special attention is given to the practicality of each method for the practicing physician.

Obesity-induced chronic inflammation is associated with the reduced efficacy of influenza vaccine.

PubMed

Park, Hye-Lim; Shim, Seung-Hyun; Lee, Eun-Young; Cho, Whajung; Park, Sooho; Jeon, Hyun-Jung; Ahn, Sun-Young; Kim, Hun; Nam, Jae-Hwan

2014-01-01

The relationship between obesity and vaccine efficacy is a serious issue. Previous studies have shown that vaccine efficacy is lower in the obese than in the non-obese. Here, we examined the influence of obesity on the efficacy of influenza vaccination using high fat diet (HFD) and regular fat diet (RFD) mice that were immunized with 2 types of influenza virus vaccines-cell culture-based vaccines and egg-based vaccines. HFD mice showed lower levels of neutralizing antibody titers as compared with RFD mice. Moreover, HFD mice showed high levels of MCP-1 in serum and adipocytes, and low level of influenza virus-specific effector memory CD8(+) T cells. After challenge with influenza virus, the lungs of HFD mice showed more severe inflammatory responses as compared with the lungs of RFD mice, even after vaccination. Taken together, our data suggested that the inflammatory condition in obesity may contribute to the suppressed efficacy of influenza vaccination.

A Study of the Relationship between Multicultural Teaching Training Methods and Teacher Attitudes about Diversity in Rural Schools

ERIC Educational Resources Information Center

Gray, Russell E.

2010-01-01

The lack of research about the efficacy of the three primary methods for training teachers to work with students from diverse cultures makes it difficult for universities to provide the proper training. The following quantitative, non-experimental, causal-comparative, ex-post facto study gathered and analyzed data concerning the efficacy of the…

Rubrics and Self-Assessment Scripts Effects on Self-Regulation, Learning and Self-Efficacy in Secondary Education

ERIC Educational Resources Information Center

Panadero, Ernesto; Tapia, Jesus Alonso; Huertas, Juan Antonio

2012-01-01

This study compares the effects of two different self-assessment tools--rubrics and scripts--on self-regulation, learning and self-efficacy in interaction with two other independent variables (type of instructions and feedback). A total of 120 secondary school students analyzed landscapes--a usual task when studying Geography--in one of twelve…

Local scale comparisons of biodiversity as a test for global protected area ecological performance: a meta-analysis.

PubMed

Coetzee, Bernard W T; Gaston, Kevin J; Chown, Steven L

2014-01-01

Terrestrial protected areas (PAs) are cornerstones of global biodiversity conservation. Their efficacy in terms of maintaining biodiversity is, however, much debated. Studies to date have been unable to provide a general answer as to PA conservation efficacy because of their typically restricted geographic and/or taxonomic focus, or qualitative approaches focusing on proxies for biodiversity, such as deforestation. Given the rarity of historical data to enable comparisons of biodiversity before/after PA establishment, many smaller scale studies over the past 30 years have directly compared biodiversity inside PAs to that of surrounding areas, which provides one measure of PA ecological performance. Here we use a meta-analysis of such studies (N = 86) to test if PAs contain higher biodiversity values than surrounding areas, and so assess their contribution to determining PA efficacy. We find that PAs generally have higher abundances of individual species, higher assemblage abundances, and higher species richness values compared with alternative land uses. Local scale studies in combination thus show that PAs retain more biodiversity than alternative land use areas. Nonetheless, much variation is present in the effect sizes, which underscores the context-specificity of PA efficacy.

In vitro-in vivo sequence studies as a method of selecting the most efficacious alcohol-based solution for hygienic hand disinfection.

PubMed

Herruzo, R; Vizcaino, M J; Herruzo, I

2010-05-01

The use of alcohol-based hand rubs serves to reduce hospital-acquired infections. Many products of this type are now on offer and it is essential to know how to rank their efficacy. A sequence of tests is proposed here to compare any given new alcohol-based solution against the reference solution (60% 2-isopropyl-alcohol) with 30 s of contact time: (i) in vitro (with pig skin as carrier) testing of >30 species of microorganism; (ii) in vitro assessment of residual efficacy (after 30 min of drying); (iii) in vivo study of transient microbiota (modification of the EN 1500 standard procedure) using four ATCC strains; (iv) in vivo study of resident hand microbiota. After performing the in vitro evaluation of seven alcohol-based hand rubs, the two most efficacious (chlorhexidine-quac-alcohol and mecetronium- alcohol) were chosen and studied, comparatively with the reference solution (60% isopropyl alcohol), in vitro (for chemical sustainability on the skin) and in vivo (against transient and resident microbiota). Chlorhexidine-quac-alcohol proved to be significantly superior to mecetronium-alcohol or the reference solution in all tests, except against resident microbiota for which the improvement was not statistically significant.

Multi-country assessment of residual bio-efficacy of insecticides used for indoor residual spraying in malaria control on different surface types: results from program monitoring in 17 PMI/USAID-supported IRS countries.

PubMed

Dengela, Dereje; Seyoum, Aklilu; Lucas, Bradford; Johns, Benjamin; George, Kristen; Belemvire, Allison; Caranci, Angela; Norris, Laura C; Fornadel, Christen M

2018-01-30

Indoor residual spraying (IRS) is the application of insecticide to the interior walls of household structures that often serve as resting sites for mosquito vectors of malaria. Human exposure to malaria vectors is reduced when IRS involves proper application of pre-determined concentrations of the active ingredient specific to the insecticide formulation of choice. The impact of IRS can be affected by the dosage of insecticide, spray coverage, vector behavior, vector susceptibility to insecticides, and the residual efficacy of the insecticide applied. This report compiles data on the residual efficacy of insecticides used in IRS campaigns implemented by the United States President's Malaria Initiative (PMI)/United States Agency for International Development (USAID) in 17 African countries and compares observed length of efficacy to ranges proposed in World Health Organization (WHO) guidelines. Additionally, this study provides initial analysis on variation of mosquito mortality depending on the surface material of sprayed structures, country spray program, year of implementation, source of tested mosquitoes, and type of insecticide. Residual efficacy of the insecticides used for PMI/USAID-supported IRS campaigns was measured in Benin, Burkina Faso, Ethiopia, Ghana, Kenya, Liberia, Madagascar, Malawi, Mali, Mozambique, Nigeria, Rwanda, Senegal, Tanzania, Uganda, Zambia and Zimbabwe. The WHO cone bioassay tests were used to assess the mortality rate of mosquitoes exposed to insecticide-treated mud, wood, cement, and other commonly used housing materials. Baseline tests were performed within weeks of IRS application and follow-up tests were continued until the mortality of exposed mosquitoes dropped below 80% or the program monitoring period ended. Residual efficacy in months was then evaluated with respect to WHO guidelines that provide suggested ranges of residual efficacy for insecticide formulations recommended for use in IRS. Where the data allowed, direct comparisons of mosquito mortality rates were then made to determine any significant differences when comparing insecticide formulation, country, year, surface type, and the source of the mosquitoes used in testing. The residual efficacy of alpha-cypermethrin ranged from 4 to 10 months (average = 6.4 months), with no reported incidents of underperformance when compared to the efficacy range provided in WHO guidelines. Deltamethrin residual efficacy results reported a range of 1 to 10 months (average = 4.9 months), with two instances of underperformance. The residual efficacy of bendiocarb ranged from 2 weeks to 7 months (average = 2.8 months) and failed to achieve proposed minimum efficacy on 14 occasions. Lastly, long-lasting pirimiphos-methyl efficacy ranged from 2 months to 9 months (average = 5.3 months), but reported 13 incidents of underperformance. Much of the data used to determine application rate and expected efficacy of insecticides approved for use in IRS programs are collected in controlled laboratory or pilot field studies. However, the generalizability of the results obtained under controlled conditions are limited and unlikely to account for variation in locally sourced housing materials, climate, and the myriad other factors that may influence the bio-efficacy of insecticides. Here, data are presented that confirm the variation in residual efficacy observed when monitoring household surfaces sprayed during PMI/USAID-supported IRS campaigns. All insecticides except alpha-cypermethrin showed evidence of failing to meet the minimum range of residual efficacy proposed in WHO criteria at least once. However, this initial effort in characterizing program-wide insecticide bio-efficacy indicates that some insecticides, such as bendiocarb and pirimiphos-methyl, may be vulnerable to variations in the local environment. Additionally, the comparative analysis performed in this study provides evidence that mosquito mortality rates differ with respect to factors including: the types of insecticide sprayed, surface material, geographical location, year of spraying, and tested mosquitoes. It is, therefore, important to locally assess the residual efficacy of insecticides on various surfaces to inform IRS programming.

What do large scale studies of medication in schizophrenia add to our management strategies?

PubMed

Agius, Mark; Davis, Abigail; Gilhooley, Michael; Chapman, Shelley; Zaman, Rashid

2010-06-01

A number of large naturalistic trials have reported in recent years comparing second generation antipsychotic drugs with their predecessors. The conclusions they draw have rightly sparked much debate, but are these studies truly comparable? If not, which of them are most methodologically robust and are these the studies most suitable as a foundation for clinical care guidelines with a strong evidence base. We aimed to conduct a review of the current literature to establish the appropriateness of several recent major clinical studies being used as the basis for clinical guidelines. A literature search using the PUBMED database was carried out. Five major studies comparing antipsychotic efficacy were selected as possible candidates and subjected to further analysis. The studies were: * CUTLASS (Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia study); * CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness study); * SOHO (Schizophrenia outpatients Health Outcomes study); * CAFE (Comparison of Atypicals in First Episode study); * EUFEST (European First Episode Schizophrenia Trial). The trials: * CAFE - the trial, although well randomised and blinded, uses discontinuation as a primary endpoint - this is hard to draw conclusions from: patients may discontinue due to side effects, due to lack of efficacy or with against medical advice for a multitude of reasons. As a secondary endpoint, the study does make use of a PANSS scoring system to measure efficacy, adding some weight to the conclusion that olanzapine, quetiaine and risperidone in early psychosis patients have equivalent efficacies. * CATIE - This trial was a comparative study, and so lacked a control arm and used discontinuation of medication an inverse measure of efficacy - an easily quantifiable event, but making for difficult interpretation. However most criticism has been directed at the unusually low (quitiapine, ziprasidone) and high (olanzapine and perphenazine) doses of drug used, which were reflected in their differing rates of efficacy. * CUtLASS This trial allows for less generalisation of its findings to the general population as it makes use a specific sub-population (those switching from one medication to another after a period of treatment). Also some patients were prescribed oral medications and some depot injections - making comparisons difficult due to possible differences in compliance. * EUFEST This trial makes use of discontinuation as an endpoint with the weaknesses we have described. Treatment of first episodes of psychosis is shown to be feasible, but it could not suggest if haloperidol or second generation drugs may be more efficacious. * SOHO - This trial hindered by the observational design of the study and small numbers reaching the primary end point (4%) caution should be exercised in the conclusion that olanzapine is superior to risperidone, quetiapine or typical antipsychotics. There is much information useful for clinical practice to be gathered from the results of these major studies, however, interpretation is hampered by both variations and weakness in study design. On balance it does appear that different antipsychotics possess differing efficacy, but also of relevance to the development of sound clinical guidelines is their differing side effects profile.

Source entitativity and the elaboration of persuasive messages: the roles of perceived efficacy and message discrepancy.

PubMed

Clark, Jason K; Wegener, Duane T

2009-07-01

Compared with nonentitative groups, entitative targets are considered to elicit more elaborative processing because of the singularity or unity they represent. However, when groups serve as sources of persuasive messages, other dynamics may operate. The current research suggests that entitativity is intrinsically linked to perceptions of a group's efficacy related to the advocacy, and this efficacy combines with the position of the appeal to determine message elaboration. When messages are counterattitudinal, entitative (efficacious) sources should elicit greater processing than nonentitative groups because of concern that the entitative sources may be more likely to bring about the negative outcomes proposed. However, when appeals are proattitudinal, sources low in entitativity (nonefficacious) should initiate more elaboration due to concern that they may be unlikely to facilitate the positive outcomes proposed. These hypotheses were supported in a series of studies. Preliminary studies established the entitativity-efficacy relation (Studies 1A and 1B). Primary persuasion studies showed that manipulations of source entitativity (Studies 2 and 3) and source efficacy (Studies 4A and 4B) have opposite effects on processing as a function of message discrepancy. (PsycINFO Database Record (c) 2009 APA, all rights reserved).

A simple experimental method to study depigmenting agents.

PubMed

Abella, M L; de Rigal, J; Neveux, S

2007-08-01

The first objective of the study was to verify that a controlled UV exposure of four areas of the forearms together with randomized product application enabled to compare treatment efficacy and then to compare the depigmenting efficacy of different products with a simple experimental method. Sixteen volunteers received 0.7 minimal erythermal dose for four consecutive days. Products tested were ellagic acid (0.5%), vitamin C (5%) and C8-LHA (2%). Product application started 72 h post last exposure, was repeated for 42 days, the control zone being exposed, non-treated. Colour measurements included Chromameter, Chromasphere, Spectro-colorimeter and visual assessment. Comparison of colour values at day 1 and at day 7 showed that all zones were comparably tanned, allowing a rigorous comparison of the treatments. We report a new simple experimental model, which enables the rapid comparison of different depigmenting products. The efficacy and good tolerance of C8-LHA make it an excellent candidate for the treatment of hyperpigmentory disorders.

The comparative evidence basis for the efficacy of second-generation antidepressants in the treatment of depression in the US: A Bayesian meta-analysis of Food and Drug Administration reviews.

PubMed

Monden, Rei; Roest, Annelieke M; van Ravenzwaaij, Don; Wagenmakers, Eric-Jan; Morey, Richard; Wardenaar, Klaas J; de Jonge, Peter

2018-08-01

Studies have shown similar efficacy of different antidepressants in the treatment of depression. Data of phase-2 and -3 clinical-trials for 16 antidepressants (levomilnacipran, desvenlafaxine, duloxetine, venlafaxine, paroxetine, escitalopram, vortioxetine, mirtazapine, venlafaxine XR, sertraline, fluoxetine, citalopram, paroxetine CR, nefazodone, bupropion, vilazodone), approved by the FDA for the treatment of depression between 1987 and 2016, were extracted from the FDA reviews that were used to evaluate efficacy prior to marketing approval, which are less liable to reporting biases. Meta-analytic Bayes factors, which quantify the strength of evidence for efficacy, were calculated. In addition, posterior pooled effect-sizes were calculated and compared with classical estimations. The resulted Bayes factors showed that the evidence load for efficacy varied strongly across antidepressants. However, all tested drugs except for bupropion and vilazodone showed strong evidence for their efficacy. The posterior effect-size distributions showed variation across antidepressants, with the highest pooled estimated effect size for venlafaxine followed by paroxetine, and the lowest for bupropion and vilazodone. Not all published trials were included in the study. The results illustrate the importance of considering both the effect size and the evidence-load when judging the efficacy of a treatment. In doing so, the currently employed Bayesian approach provided clear insights on top of those gained with traditional approaches. Copyright © 2018 Elsevier B.V. All rights reserved.

Reduction in the urinary aflatoxin M1 biomarker as an early indicator of the efficacy of dietary interventions to reduce exposure to aflatoxins.

PubMed

Mitchell, Nicole J; Kumi, Justice; Johnson, Natalie M; Dotse, Eunice; Marroquin-Cardona, Alicia; Wang, Jia-Sheng; Jolly, Pauline E; Ankrah, Nii-Ayi; Phillips, Timothy D

2013-08-01

Aflatoxin B1 is a persistent public health issue in Ghana. Assessment of AFB1 intervention efficacy is currently dependent on long-term biomarkers. This study was designed to determine whether daily AFM1 biomarker levels could be utilized as an early detection method for intervention efficacy. Participants were treated with a refined calcium montmorillonite clay (UPSN) or a placebo (calcium carbonate) in a crossover study. Urine samples were assessed for AFM1 levels daily. UPSN treatment reduced AFM1 biomarkers by 55% compared to the placebo. This is the first study to show that daily urinary AFM1 levels can be used as a biomarker of internal aflatoxin B1 exposure in short-term intervention trials to determine efficacy.

Evaluation of Course-Specific Self-Efficacy Assessment Methods.

ERIC Educational Resources Information Center

Bong, Mimi

A study was conducted to compare three methods of assessing course-level self-efficacy beliefs within a multitrait multimethod (MTMM) framework. The methods involved: (1) successfully performing a number of domain-related tasks; (2) obtaining specific letter grades in the course; and (3) successfully performing generic academic tasks in the…

Teacher Self-Efficacy in a Classical Christian Environment versus a Traditional Christian Environment

ERIC Educational Resources Information Center

Anderson, Emily Rose

2016-01-01

Teachers in a classical Christian environment oftentimes are not taught in the classic manner themselves, requiring different training from that in teacher-education programs. This study compared teacher self-efficacy between traditional Christian-education environments and classical Christian-education environments. The purpose of this…

Self-Efficacy, Adversity Quotient, and Students' Achievement in Mathematics

ERIC Educational Resources Information Center

Suryadi, Bambang; Santoso, Teguh Iman

2017-01-01

Indonesian students' achievement in mathematics is generally still low compared with other countries. Many psychological factors, both internal and external, influence this poor performance. This study aimed to measure the effect of self-efficacy and the adversity quotient of Grade IX students regarding achievement in mathematics. Both of these…

Study on the efficacy of ELA-Max (4% liposomal lidocaine) compared with EMLA cream (eutectic mixture of local anesthetics) using thermosensory threshold analysis in adult volunteers.

PubMed

Tang, M B Y; Goon, A T J; Goh, C L

2004-04-01

ELA-Max and EMLA cream are topical anesthetics that have been shown to have similar anesthetic efficacy in previous studies. To evaluate the analgesic efficacy of ELA-Max in comparison with EMLA cream using a novel method of thermosensory threshold analysis. A thermosensory analyzer was used to assess warmth- and heat-induced pain thresholds. No statistically significant difference was found in pain thresholds using either formulation. However, EMLA cream increased the heat-induced pain threshold to a greater extent than ELA-Max. Thermosensory measurement and analysis was well tolerated and no adverse events were encountered. EMLA cream may be superior to ELA-Max for heat-induced pain. This study suggests that thermosensory measurement may be another suitable tool for future topical anesthetic efficacy studies.

The effect of neck-specific exercise with, or without a behavioral approach, on pain, disability, and self-efficacy in chronic whiplash-associated disorders: a randomized clinical trial.

PubMed

Ludvigsson, Maria L; Peterson, Gunnel; O'Leary, Shaun; Dedering, Åsa; Peolsson, Anneli

2015-04-01

The aim of this study was to compare the effect on self-rated pain, disability, and self-efficacy of 3 interventions for the management of chronic whiplash-associated disorders: physiotherapist-led neck-specific exercise (NSE), physiotherapist-led NSE with the addition of a behavioral approach, or Prescription of Physical Activity (PPA). A total of 216 volunteers with chronic whiplash-associated disorders participated in this randomized, assessor blinded, clinical trial of 3 exercise interventions. Self-rated pain/pain bothersomeness (Visual Analogue Scale), disability (Neck Disability Index), and self-efficacy (Self-Efficacy Scale) were evaluated at baseline and at 3 and 6 months. The proportion of patients reaching substantial reduction in pain bothersomness (at least 50% reduction) was more evident (P<0.01) in the 2 NSE groups (29% to 48%) compared with the PPA group (5%) at 3 months. At 6 months 39% to 44% of the patients in the 2 neck-specific groups and 28% in the PPA group reported substantial pain reduction. Reduction of disability was also larger in the 2 neck-specific exercise groups at both 3 and 6 months (P<0.02). Self-efficacy was only improved in the NSE group without a behavioral approach (P=0.02). However, there were no significant differences in any outcomes between the 2 physiotherapist-led NSE groups. NSE resulted in superior outcomes compared with PPA in this study, but the observed benefits of adding a behavioral approach to the implementation of exercise in this study were inconclusive.

Rationale for the tinnitus retraining therapy trial

PubMed Central

Formby, Craig; Scherer, Roberta

2013-01-01

The Tinnitus Retraining Therapy Trial (TRTT) is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT) and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1) directive counseling and sound therapy using conventional sound generators; (2) directive counseling and placebo sound generators; or (3) standard of care as administered in the military. Study centers include a Study Chair’s Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ) score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators) with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant’s life. PMID:23571304

The Effect of Neck-specific Exercise With, or Without a Behavioral Approach, on Pain, Disability, and Self-Efficacy in Chronic Whiplash-associated Disorders

PubMed Central

Peterson, Gunnel; O’Leary, Shaun; Dedering, Åsa; Peolsson, Anneli

2015-01-01

Objectives: The aim of this study was to compare the effect on self-rated pain, disability, and self-efficacy of 3 interventions for the management of chronic whiplash-associated disorders: physiotherapist-led neck-specific exercise (NSE), physiotherapist-led NSE with the addition of a behavioral approach, or Prescription of Physical Activity (PPA). Materials and Methods: A total of 216 volunteers with chronic whiplash-associated disorders participated in this randomized, assessor blinded, clinical trial of 3 exercise interventions. Self-rated pain/pain bothersomeness (Visual Analogue Scale), disability (Neck Disability Index), and self-efficacy (Self-Efficacy Scale) were evaluated at baseline and at 3 and 6 months. Results: The proportion of patients reaching substantial reduction in pain bothersomness (at least 50% reduction) was more evident (P<0.01) in the 2 NSE groups (29% to 48%) compared with the PPA group (5%) at 3 months. At 6 months 39% to 44% of the patients in the 2 neck-specific groups and 28% in the PPA group reported substantial pain reduction. Reduction of disability was also larger in the 2 neck-specific exercise groups at both 3 and 6 months (P<0.02). Self-efficacy was only improved in the NSE group without a behavioral approach (P=0.02). However, there were no significant differences in any outcomes between the 2 physiotherapist-led NSE groups. Discussion: NSE resulted in superior outcomes compared with PPA in this study, but the observed benefits of adding a behavioral approach to the implementation of exercise in this study were inconclusive. PMID:24918474

Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: mixed treatment comparison analysis of 22 844 patient years of follow-up from randomised trials

PubMed Central

Kumar, Sunil; Fusaro, Mario; Amoroso, Nicholas; Kirtane, Ajay J; Byrne, Robert A; Williams, David O; Slater, James; Cutlip, Donald E; Feit, Frederick

2012-01-01

Objectives To evaluate the efficacy and safety of currently used drug eluting stents compared with each other and compared with bare metal stents in patients with diabetes. Design Mixed treatment comparison meta-analysis. Data sources and study selection PubMed, Embase, and CENTRAL were searched for randomised clinical trials, until April 2012, of four durable polymer drug eluting stents (sirolimus eluting stents, paclitaxel eluting stents, everolimus eluting stents, and zotarolimus eluting stents) compared with each other or with bare metal stents for the treatment of de novo coronary lesions and enrolling at least 50 patients with diabetes. Primary outcomes Efficacy (target vessel revascularisation) and safety (death, myocardial infarction, stent thrombosis). Results From 42 trials with 22 844 patient years of follow-up, when compared with bare metal stents (reference rate ratio 1) all of the currently used drug eluting stents were associated with a significant reduction in target vessel revascularisation (37% to 69%), though the efficacy varied with the type of stent (everolimus eluting stents∼sirolimus eluting stents>paclitaxel eluting stents∼zotarolimus eluting stent>bare metal stents). There was about an 87% probability that everolimus eluting stents were the most efficacious compared with all others, though there were limited usable data for the zotarolimus eluting Resolute stent in patients with diabetes. Moreover, there was no increased risk of any safety outcome (including very late stent thrombosis) with any drug eluting stents compared with bare metal stents. There was about a 62% probability that the everolimus eluting stent was the safest stent for the outcome of “any” stent thrombosis. Conclusions Among patients with diabetes treated with coronary stents all currently available drug eluting stents were efficacious without compromising safety compared with bare metal stents. There were relative differences among the drug eluting stents, such that the everolimus eluting stent was the most efficacious and safe. PMID:22885395

The development of an instrument to measure the self-efficacy of students participating in VEX robotics competitions

NASA Astrophysics Data System (ADS)

Robinson, Trevor P.

The number of robotics competitions has steadily increased over the past 30 years. Schools are implementing robotics competitions to increase student content knowledge and interest in science, technology, engineering, and mathematics (STEM). Companies in STEM-related fields are financially supporting robotics competitions to help increase the number of students pursuing careers in STEM among other reasons. These financial supporters and school administrations are asking what the outcomes of students participating in competitive robotics are. Few studies have been conducted to investigate these outcomes. The studies that have been conducted usually compare students in robotics to students not in robotics. There have not been any studies that compare students to themselves before and after participating in robotics competitions. This may be due to the lack of available instruments to measure student outcomes. This study developed an instrument to measure the self-efficacy of students participating in VEX Robotics Competitions (VRC). The VRC is the world's largest and fastest growing robotics competition available for middle and high school students. Self-efficacy was measured because of its importance to the education community. Students with higher self-efficacy tend to persevere through difficult tasks more frequently than students with low self-efficacy. A person's self-efficacy has major influence over what interests, activities, classes, college majors, and careers he or she will pursue in life. The self-efficacy survey instrument created through this study was developed through an occupational and task analysis (OTA), and initial content and face validity was established through the OTA process. Exploratory and confirmatory factor analyses were also conducted to assist in instrument validation. The reliability was calculated using Cronbach's alpha. Face validity was established through the OTA process. Construct validity was established through the factor analyses. The processes of the OTA and factor analyses have created an instrument that results indicate is reliable and valid to use in further research studies.

Which is the better timing between embolization and surgery for hypervascular spinal tumors, the same day or the next day?: A retrospective comparative study.

PubMed

Tang, Benqiang; Ji, Tao; Guo, Wei; Tang, Xiaodong; Jin, Long; Dong, Sen; Xie, Lu

2018-06-01

Previous series presented the timing between embolization and surgery in a wide range on the basis of their experience rather than supportive data. And comparative studies were limited to small samples. In addition, there is no study publishing the timing by considering both safety and efficacy of embolization. The aim of this study was to determine the better timing (the same day or the next day) between embolization and surgery for hypervascular spinal tumors by assessing the safety and efficacy of embolization.One hundred twenty-five embolizations with subsequent 120 operations for hypervascular spinal tumors between January 2010 and April 2013 were retrospectively reviewed. The time between embolization and surgery was mainly determined by interventional radiologist schedules and operating room available. Major complications of embolization were documented. The efficacy of embolization was compared between the same day and the next day group.Of the 125 embolizations, there were 4 major complications, all of which occurred on the same day of procedure. Of the 120 operations, 36 cases were operated on the same day of embolization, 74 on the next day, and 10 on the second day. When comparing the efficacy of embolization between the same day and the next day group, intraoperative blood loss (1483 ± 1475 vs 1548 ± 1099 mL, P = .80), intraoperative transfusion requirement (1011 ± 1200 vs 1112 ± 890 mL, P = .62), and postoperative blood loss (1146 ± 933 vs 1031 ± 777 mL, P = .50) were not significantly different.Embolization carries certain risks (4/125, 3.2%) for major complications, which may occur within the time window of 1 day. Two patient groups showed no difference on the efficacy of embolization. Operation should be scheduled on the next day of embolization if possible.

Creating opportunities to influence self-efficacy through modeling instruction

NASA Astrophysics Data System (ADS)

Sawtelle, Vashti; Brewe, Eric; Goertzen, Renee Michelle; Kramer, Laird H.

2012-02-01

In this paper we present an initial analysis connecting key elements of Modeling Instruction (MI) to self-efficacy experience opportunities. Previously, we demonstrated that MI has positive effects on self-efficacy when compared with traditional Lecture instruction [1]. We also found a particularly strong positive effect on the social persuasion source of self-efficacy for women in the MI class. Our current study seeks to understand through what mechanisms MI influences self-efficacy. We demonstrate this connection through an in-depth analysis of video chosen to exemplify Modeling techniques used in a problem-solving episode by three female participants enrolled in a MI introductory physics class. We provide a rich and descriptive analysis of the self-efficacy experiences opportunities within this context and discuss how these opportunities provide a potential explanation of how MI influences self-efficacy.

Efficacy of brief telephone psychotherapy with callers to a suicide hotline.

PubMed

Rhee, Wayne K; Merbaum, Michael; Strube, Michael J; Self, Susan M

2005-06-01

The efficacy of two types of theapy conducted exclusively over the telephone was studied. Clients (N=55) were recruited from a pool of callers to a suicide hotline and were randomly assigned to a waiting list control (WC) or Solution Focused Brief Therapy (SFBT) or Common Factors Therapy (CFT). It was hypothesized that improvements would be significantly higher in the two therapy conditions compared to the waitlist control and SFBT would be significantly more efficacious than CFT. Results confirmed that improvement was significantly higher in the two treatment conditions compared to the waitlist control, but no difference in improvement was found between SFBT and CFT. The implications of these findings for suicide hotlines are discussed.

Antibiotic Treatment of Experimental Pneumonic Plague in Mice

PubMed Central

Byrne, William R.; Welkos, Susan L.; Pitt, M. Louise; Davis, Kelly J.; Brueckner, Ralf P.; Ezzell, John W.; Nelson, Gene O.; Vaccaro, Joseph R.; Battersby, Luann C.; Friedlander, Arthur M.

1998-01-01

A mouse model was developed to evaluate the efficacy of antibiotic treatment of pneumonic plague; streptomycin was compared to antibiotics with which there is little or no clinical experience. Infection was induced by inhalation of aerosolized Yersinia pestis organisms. Antibiotics were administered by intraperitoneal injection every 6 hours for 5 days, at doses that produced levels of drug in serum comparable to those observed in humans treated for other serious infections. These studies compared in vitro to in vivo activity and evaluated the efficacy of antibiotics started at different times after exposure. Early treatment (started 24 h after challenge, when 0 of 10 mice tested had positive blood cultures) with netilmicin, ciprofloxacin, ofloxacin, ceftriaxone, ceftazidime, aztreonam, ampicillin, and rifampin (but not cefazolin, cefotetan, or ceftizoxime) demonstrated efficacy comparable to streptomycin. Late treatment (started 42 h after exposure, when five of five mice tested had positive blood cultures) with netilmicin, ciprofloxacin, ofloxacin, and a high dose (20 mg/kg of body weight every 6 h) of gentamicin produced survival rates comparable to that with streptomycin, while all of the beta-lactam antibiotics (cefazolin, cefotetan, ceftriaxone, ceftazidime, aztreonam, and ampicillin) and rifampin were significantly inferior to streptomycin. In fact, all groups of mice treated late with beta-lactam antibiotics experienced accelerated mortality rates compared to normal-saline-treated control mice. These studies indicate that netilmicin, gentamicin, ciprofloxacin, and ofloxacin may be alternatives for the treatment of pneumonic plague in humans. However, the beta-lactam antibiotics are not recommended, based upon poor efficacy in this mouse model of pneumonic plague, particularly when pneumonic plague may be associated with bacteremia. PMID:9517950

An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine.

PubMed

Carson, Shannon S; Goss, Christopher H; Patel, Sanjay R; Anzueto, Antonio; Au, David H; Elborn, Stuart; Gerald, Joe K; Gerald, Lynn B; Kahn, Jeremy M; Malhotra, Atul; Mularski, Richard A; Riekert, Kristin A; Rubenfeld, Gordon D; Weaver, Terri E; Krishnan, Jerry A

2013-11-15

Comparative effectiveness research (CER) is intended to inform decision making in clinical practice, and is central to patient-centered outcomes research (PCOR). To summarize key aspects of CER definitions and provide examples highlighting the complementary nature of efficacy and CER studies in pulmonary, critical care, and sleep medicine. An ad hoc working group of the American Thoracic Society with experience in clinical trials, health services research, quality improvement, and behavioral sciences in pulmonary, critical care, and sleep medicine was convened. The group used an iterative consensus process, including a review by American Thoracic Society committees and assemblies. The traditional efficacy paradigm relies on clinical trials with high internal validity to evaluate interventions in narrowly defined populations and in research settings. Efficacy studies address the question, "Can it work in optimal conditions?" The CER paradigm employs a wide range of study designs to understand the effects of interventions in clinical settings. CER studies address the question, "Does it work in practice?" The results of efficacy and CER studies may or may not agree. CER incorporates many attributes of outcomes research and health services research, while placing greater emphasis on meeting the expressed needs of nonresearcher stakeholders (e.g., patients, clinicians, and others). CER complements traditional efficacy research by placing greater emphasis on the effects of interventions in practice, and developing evidence to address the needs of the many stakeholders involved in health care decisions. Stakeholder engagement is an important component of CER.

Perceived efficacy of herbal remedies by users accessing primary healthcare in Trinidad

PubMed Central

Clement, Yuri N; Morton-Gittens, Jamie; Basdeo, Luke; Blades, Alexander; Francis, Marie-Joanna; Gomes, Natalie; Janjua, Meer; Singh, Adelle

2007-01-01

Background The increasing global popularity of herbal remedies requires further investigation to determine the probable factors driving this burgeoning phenomenon. We propose that the users' perception of efficacy is an important factor and assessed the perceived efficacy of herbal remedies by users accessing primary health facilities throughout Trinidad. Additionally, we determined how these users rated herbal remedies compared to conventional allopathic medicines as being less, equally or more efficacious. Methods A descriptive cross-sectional study was undertaken at 16 randomly selected primary healthcare facilities throughout Trinidad during June-August 2005. A de novo, pilot-tested questionnaire was interviewer-administered to confirmed herbal users (previous or current). Stepwise multiple regression analysis was done to determine the influence of predictor variables on perceived efficacy and comparative efficacy with conventional medicines. Results 265 herbal users entered the study and cited over 100 herbs for the promotion of health/wellness and the management of specific health concerns. Garlic was the most popular herb (in 48.3% of the sample) and was used for the common cold, cough, fever, as 'blood cleansers' and carminatives. It was also used in 20% of hypertension patients. 230 users (86.8%) indicated that herbs were efficacious and perceived that they had equal or greater efficacy than conventional allopathic medicines. Gender, ethnicity, income and years of formal education did not influence patients' perception of herb efficacy; however, age did (p = 0.036). Concomitant use of herbs and allopathic medicines was relatively high at 30%; and most users did not inform their attending physician. Conclusion Most users perceived that herbs were efficacious, and in some instances, more efficacious than conventional medicines. We suggest that this perception may be a major contributing factor influencing the sustained and increasing popularity of herbs. Evidence-based research in the form of randomized controlled clinical trials should direct the proper use of herbs to validate (or otherwise) efficacy and determine safety. In the Caribbean, most indigenous herbs are not well investigated and this points to the urgent need for biomedical investigations to assess the safety profile and efficacy of our popular medicinal herbs. PMID:17286858

Systematic review of published studies on safety and efficacy of thoracoscopic and robot-assisted lobectomy for lung cancer.

PubMed

Nakamura, Hiroshige

2014-01-01

The safety and efficacy of thoracoscopic and robot-assisted lobectomies for primary lung cancer were reviewed in the literature. Thoracoscopic surgery is less invasive compared to thoracotomy, and it has been reported to be superior with regard to the outcome. In addition, the operability of a surgical robot (da Vinci) is favorable and supplements the disadvantages of conventional endoscopic surgery. Robot-assisted lobectomy has been reported to be comparable to thoracoscopic surgery with regard to the safety and efficacy based on analysis of perioperative results and superior with regard to the operability and length of the learning curve. However, a high cost and a long operative time are of concern. Since robot-assisted surgery has been performed only in early cases, the continuation of a comparative investigation may be necessary.

Teachers' Sense of Efficacy: Examining the Relationship of Teacher Efficacy and Student Achievement

NASA Astrophysics Data System (ADS)

Alrefaei, Nouf

The purpose of this study was to investigate which teachers' characteristics have an impact on teachers' sense of efficacy. In addition, the relationship between mathematics and science fifth grade teachers' sense of efficacy and student achievement was examined. Two characteristics related to teachers were examined: teachers' years of teaching experience and teachers' highest degree. Participants included 62 mathematics and science teachers from three school districts in Northwest Arkansas. When comparing fifth grade mathematics and science teachers' efficacy beliefs based on their highest degree, a significant difference in teachers' efficacy beliefs was found based on their degrees. Teachers with a Bachelor degree have higher total efficacy than teachers who hold Master's degrees. Moreover, an investigation to determine if there is a difference in mathematics and science teachers' efficacy beliefs in the three subscale of teachers' efficacy (for classroom management, for student engagement, and for instructional strategies) revealed a significant difference in teachers' efficacy for two of the three constructs. However, when examining teachers' sense of efficacy based on their teaching experience, no differences in teachers' efficacy were found. A correlation was conducted and the results indicated that there was no significant relationship between fifth grade teachers' sense of efficacy and students' achievement in the benchmark test in mathematics and science. The recommendations from this study should be used to inform other scholars and administrators of the importance of teachers' sense of efficacy in order to improve students' achievement gains.

Efficacy of transcutaneous electrical nerve stimulation for rotator cuff tendinopathy: a systematic review.

PubMed

Desmeules, F; Boudreault, J; Roy, J S; Dionne, C E; Frémont, P; MacDermid, J C

2016-03-01

To perform a systematic review on the efficacy of transcutaneous electrical nerve stimulation (TENS) for the treatment of rotator cuff tendinopathy in adults. A literature search was conducted in four databases (CINAHL, Embase, PubMed and PeDRO) for randomised controlled trials published from date of inception until April 2015, comparing the efficacy of TENS for the treatment of rotator cuff tendinopathy with placebo or any other intervention. Risk of bias was evaluated using the Cochrane risk of bias tool. Results were summarised qualitatively. Six studies were included in this review. The mean methodological score was 49% (standard deviation 16%), indicating an overall high risk of bias. One placebo-controlled trial reported that a single TENS session provided immediate pain reduction for patients with rotator cuff tendinopathy, but did not follow the participants in the short, medium or long term. Two trials that compared ultrasound therapy with TENS reported discrepancy and contradictory results in terms of pain reduction and shoulder range of motion. Corticosteroid injections were found to be superior to TENS for pain reduction in the short term, but the differences were not clinically important. Other studies included in this review concluded that TENS was not superior to heat or pulsed radiofrequency. Due to the limited number of studies and the overall high risk of bias of the studies included in this review, no conclusions can be drawn on the efficacy of TENS for the treatment of rotator cuff tendinopathy. More methodologically sound studies are needed to document the efficacy of TENS. Until then, clinicians should prefer other evidence-based rehabilitation interventions proven to be efficacious to treat patients with rotator cuff tendinopathy. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Equine-assisted activities and the impact on perceived social support, self-esteem and self-efficacy among adolescents – an intervention study

PubMed Central

Hauge, Hilde; Kvalem, Ingela L.; Berget, Bente; Enders-Slegers, Marie-José; Braastad, Bjarne O.

2013-01-01

In this project, we examined the effect of a 4-month intervention with horses on perceived social support, self-esteem and general self-efficacy among Norwegian adolescents aged 12–15 years. The intervention took place at farm-based stables and included work with the horses and riding. A waiting-list crossover design was used and the participants answered questionnaires at three time periods. Study I (N = 49) examined the effect of the intervention compared with the control group. Study II (N = 41) examined the relationship between the same psychological variables and change in mastering skills with horse. The intervention group reported a significant increase in perceived social support compared with the control group. There were no differences in self-esteem and general self-efficacy between the groups. The results from study II showed that a lower level of perceived social support prior to the intervention predicted an increase in mastering skills with the horse during the intervention. PMID:24833811

A study comparing the hypnotic efficacies and residual effects on actual driving performance of midazolam 15 mg, triazolam 0.5 mg, temazepam 20 mg and placebo in shiftworkers on night duty

DOT National Transportation Integrated Search

1988-11-01

The purpose of the study was to determine the hypnotic efficacy and residual effects of three hypnotics administered for the treatment of transient insomnia in the day-sleep of rotating shift workers. The average duration of day-sleep in rotating shi...

Comparison of Self-Efficacy between Male and Female Pre-Service Early Childhood Teachers

ERIC Educational Resources Information Center

Sak, Ramazan

2015-01-01

Teaching in early childhood classrooms is a female-dominated job all over the world. The aim of this study is to compare male and female pre-service early childhood teachers' sense of self-efficacy. The study sample of 451 pre-service teachers consisted of 231 female and 220 males. The Turkish-language version of the Teachers' Sense of Efficacy…

Review of the Persistence of Herpes Zoster Vaccine Efficacy in Clinical Trials.

PubMed

Cook, Stephen J; Flaherty, Dennis K

2015-11-01

The live attenuated herpes zoster vaccine(*) was approved for the prevention of shingles in 2006. Initial Phase III clinical trials proved vaccine efficacy persisted during the study duration; however, assessment of long-term efficacy required additional studies. This article reviews efficacy data for the zoster vaccine that have been published since 2004. It focuses on studies assessing declining vaccine efficacy. MEDLINE, EMBASE, CENTRAL, and CINAHL databases were searched for zoster vaccine efficacy trials. Randomized controlled trials published from 2004 to 2015 were included in the review. Six studies were included in the review. The zoster vaccine reduced the risk of herpes zoster by 51.3% to 72.4% in 2 Phase III trials. Primary and other analyses showed the vaccine was effective at reducing the burden of illness (61.1%), postherpetic neuralgia (66.5%), disease interference on functional status (66.2%), and disease impact on health-related quality of life (55%) compared with placebo. Surveillance studies showed a decrease in vaccine efficacy for reducing the incidence of herpes zoster during follow-up years 3.3 to 7.8 (39.6% relative reduction) and 4.7 to 11.6 (21.1% relative reduction). Initial zoster vaccine efficacy is significant, but declines in post-vaccination years 3 to 11. This raises the question about the need for possible revaccination with the zoster vaccine. Clinicians should consider the declining efficacy when administering the zoster vaccine to patients. Future studies will need to address the impact of the varicella vaccine on the incidence of shingles and whether this impacts the efficacy of the zoster vaccine. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Comparison of Kato-Katz thick-smear and McMaster egg counting method for the assessment of drug efficacy against soil-transmitted helminthiasis in school children in Jimma Town, Ethiopia.

PubMed

Bekana, Teshome; Mekonnen, Zeleke; Zeynudin, Ahmed; Ayana, Mio; Getachew, Mestawet; Vercruysse, Jozef; Levecke, Bruno

2015-10-01

There is a paucity of studies that compare efficacy of drugs obtained by different diagnostic methods. We compared the efficacy of a single oral dose albendazole (400 mg), measured as egg reduction rate, against soil-transmitted helminth infections in 210 school children (Jimma Town, Ethiopia) using both Kato-Katz thick smear and McMaster egg counting method. Our results indicate that differences in sensitivity and faecal egg counts did not imply a significant difference in egg reduction rate estimates. The choice of a diagnostic method to assess drug efficacy should not be based on sensitivity and faecal egg counts only. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Fibrin chain cross-linking, fibrinolysis, and in vivo sealing efficacy of differently structured fibrin sealants.

PubMed

Hedrich, Hans Christian; Simunek, Manuela; Reisinger, Sonja; Ferguson, James; Gulle, Heinz; Goppelt, Andreas; Redl, Heinz

2012-08-01

In this study, we compared the sealing characteristics and efficacy of a fibrin sealant with reduced plasminogen (FS-rplg) and a fibrin sealant with aprotinin as a fibrinolysis inhibitor (FS-apr). The relevant sealing characteristics including clot structure, fibrin chain cross-linking, and clot lysis were tested in the laboratory. The sealing efficacy was then investigated in a follow-up animal model to determine differences in the in vivo sealing properties. A total of 46 animals were available for the final analysis with 23 animals in each treatment arm. In conclusion, we saw differences in vitro between FS-rplg and FS-apr in ultrastructure and α-chain cross-linking rates as well as in the rate of fibrinolysis. These differences may explain the significantly enhanced sealing efficacy in FS-apr compared to FS-rplg shown in vivo in a rabbit intestinal model. Copyright © 2012 Wiley Periodicals, Inc.

Impact of Physical Activity Intervention Programs on Self-Efficacy in Youths: A Systematic Review

PubMed Central

Cataldo, Rosa; John, Janice; Chandran, Latha; Pati, Susmita; Shroyer, A. Laurie W.

2013-01-01

Lack of physical activity has contributed to the nation's childhood obesity crisis, but the impact of physical activity on self-efficacy as a mediator of behavior change has not been examined. This systematic review (SR) describes the published evidence related to the impact of physical activity intervention programs on self-efficacy among youths. From January 2000 to June 2011, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards were used to identify publications from PubMed, PsychInfo, Web of Knowledge, and the Cochran Database of Systematic Reviews. The Cochrane Population, Intervention, Control, Outcome, Study Design (PICOS) approach guided this SR articles selection and evaluation process. Of the 102 publications screened, 10 original studies matched the SR inclusion criteria. The types of physical activity interventions and self-efficacy assessments for these 10 studies were diverse. Of the 10 included articles, 6 articles identified an improvement in post-self-efficacy assessments compared to baseline and 4 showed no effect. In conclusion, physical activity intervention programs may improve self-efficacy in youths. A standardized approach to classify and measure self-efficacy is required. Further research is needed to quantify the association of self-efficacy ratings after completing physical activity interventions with objective health improvements, such as weight loss. PMID:24555151

Retention of basic life support knowledge, self-efficacy and chest compression performance in Thai undergraduate nursing students.

PubMed

Partiprajak, Suphamas; Thongpo, Pichaya

2016-01-01

This study explored the retention of basic life support knowledge, self-efficacy, and chest compression performance among Thai nursing students at a university in Thailand. A one-group, pre-test and post-test design time series was used. Participants were 30 nursing students undertaking basic life support training as a care provider. Repeated measure analysis of variance was used to test the retention of knowledge and self-efficacy between pre-test, immediate post-test, and re-test after 3 months. A Wilcoxon signed-rank test was used to compare the difference in chest compression performance two times. Basic life support knowledge was measured using the Basic Life Support Standard Test for Cognitive Knowledge. Self-efficacy was measured using the Basic Life Support Self-Efficacy Questionnaire. Chest compression performance was evaluated using a data printout from Resusci Anne and Laerdal skillmeter within two cycles. The training had an immediate significant effect on the knowledge, self-efficacy, and skill of chest compression; however, the knowledge and self-efficacy significantly declined after post-training for 3 months. Chest compression performance after training for 3 months was positively retaining compared to the first post-test but was not significant. Therefore, a retraining program to maintain knowledge and self-efficacy for a longer period of time should be established after post-training for 3 months. Copyright © 2015 Elsevier Ltd. All rights reserved.

Efficacy of tulathromycin compared with tilmicosin and florfenicol for the control of respiratory disease in cattle at high risk of developing bovine respiratory disease.

PubMed

Rooney, Kathleen A; Nutsch, Robert G; Skogerboe, Terry L; Weigel, Daniel J; Gajewski, Kimberly; Kilgore, W Randal

2005-01-01

Three studies conducted at feedlots in Colorado, Idaho, and Texas examined the comparative efficacy of tulathromycin injectable solution for the treatment of cattle at high risk of developing undifferentiated bovine respiratory disease (BRD). Each study randomly allocated 250 calves to receive tulathromycin at 2.5 mg/kg and 250 calves to receive either tilmicosin at 10 mg/kg (Colorado site) or florfenicol at 40 mg/kg (Idaho and Texas sites) on arrival at the feedlot. Calves were housed by treatment group in pens with 50 calves/pen. Beginning 3 days after antimicrobial treatment, cattle were observed for signs of BRD daily until harvest. In all three studies, the treatment success rates at 28 days after treatment and at harvest were significantly higher (P < or = .013) for cattle treated with tulathromycin than for cattle treated with either tilmicosin or florfenicol. Fewer tulathromycin-treated cattle were removed from the group as "chronics" or "mortalities" at 28 days posttreatment (P < or = .014) in all three studies. Tulathromycin demonstrated superior efficacy compared with tilmicosin and florfenicol when treating groups of high-risk cattle before the onset of signs of BRD.

A comparative clinical study evaluating stain removal efficacy of a new sensitivity whitening dentifrice compared to commercially available whitening dentifrices.

PubMed

Hughes, Nathan; Maggio, Brenda; Sufi, Farzana; Mason, Stephen; Kleber, Carl J

2009-01-01

To assess the extrinsic stain removal efficacy of a new sensitivity dentifrice containing sodium tripolyphosphate (STP) to marketed whitening toothpastes after six weeks of product use. This was a single-center, double-blind, stratified, six-week clinical study comparing the reduction in stain area and intensity of Sensodyne Extra Whitening to Crest Maximum Strength Sensitivity Protection Whitening plus Scope and Colgate Tartar Control Plus Whitening Mint dentifrice, as measured by MacPherson's Modification of the Lobene Stain Index (MMLSI) in a forced stain model. Two-hundred and ninety-five subjects completed the study. Tooth stain MMSLI scores showed significant differences between Sensodyne and Crest dentifrices in favor of Sensodyne for all surface sites (p = 0.014), and individually for facial (p = 0.023), lingual (p = 0.027), and interproximal (p = 0.014) surfaces. No significant statistical differences between Sensodyne and Colgate dentifrices were observed for any of the surfaces. Results from this stain removal clinical study demonstrate significant extrinsic stain removal efficacy for all dentifrices relative to baseline. Significant differences between the two marketed sensitivity whitening dentifrices were demonstrated in favor of the new Sensodyne Sensitivity Whitening dentifrice.

Perceived threat, risk perception, and efficacy beliefs related to SARS and other (emerging) infectious diseases: results of an international survey.

PubMed

de Zwart, Onno; Veldhuijzen, Irene K; Elam, Gillian; Aro, Arja R; Abraham, Thomas; Bishop, George D; Voeten, Hélène A C M; Richardus, Jan Hendrik; Brug, Johannes

2009-01-01

To study the levels of perceived threat, perceived severity, perceived vulnerability, response efficacy, and self-efficacy for severe acute respiratory syndrome (SARS) and eight other diseases in five European and three Asian countries. A computer-assisted phone survey was conducted among 3,436 respondents. The questionnaire focused on perceived threat, vulnerability, severity, response efficacy, and self-efficacy related to SARS and eight other diseases. Perceived threat of SARS in case of an outbreak in the country was higher than that of other diseases. Perceived vulnerability of SARS was at an intermediate level and perceived severity was high compared to other diseases. Perceived threat for SARS varied between countries in Europe and Asia with a higher perceived severity of SARS in Europe and a higher perceived vulnerability in Asia. Response efficacy and self-efficacy for SARS were higher in Asia compared to Europe. In multiple linear regression analyses, country was strongly associated with perceived threat. The relatively high perceived threat for SARS indicates that it is seen as a public health risk and offers a basis for communication in case of an outbreak. The strong association between perceived threat and country and different regional patterns require further research.

The effect of modified trampoline training on balance, gait, and falls efficacy of stroke patients

PubMed Central

Hahn, Joohee; Shin, Seonhae; Lee, Wanhee

2015-01-01

[Purpose] This research was conducted to investigate the effects of modified trampoline training on the balance, gait, and falls efficacy of stroke patients. [Subjects] Twenty-four stroke patients participated in this study. The subjects were randomly allocated to one of two groups: the trampoline group (n=12) or the control group (n=12). [Methods] Both groups participated in conventional physical therapy for thirty minutes per day, three times a week for six weeks. The trampoline group also took part in trampoline training for thirty minutes per day, three times a week for six weeks. We evaluated balance (Berg balance scale, timed up and go test), gait (dynamic gait index), and falls efficacy (falls efficacy scale-K) to confirm the effects of the intervention. [Results] Both the trampoline and the control group showed significant improvements in balance, gait, and falls efficacy compared to before the intervention, and the improvements were significantly greater in the trampoline group than in the control group. [Conclusion] Modified trampoline training resulted in significantly improved balance, dynamic gait, and falls efficacy of stroke patients compared to the control group. These results suggest that modified trampoline training is feasible and effective at improving balance, dynamic gait, and falls efficacy after stroke. PMID:26696696

The effect of modified trampoline training on balance, gait, and falls efficacy of stroke patients.

PubMed

Hahn, Joohee; Shin, Seonhae; Lee, Wanhee

2015-11-01

[Purpose] This research was conducted to investigate the effects of modified trampoline training on the balance, gait, and falls efficacy of stroke patients. [Subjects] Twenty-four stroke patients participated in this study. The subjects were randomly allocated to one of two groups: the trampoline group (n=12) or the control group (n=12). [Methods] Both groups participated in conventional physical therapy for thirty minutes per day, three times a week for six weeks. The trampoline group also took part in trampoline training for thirty minutes per day, three times a week for six weeks. We evaluated balance (Berg balance scale, timed up and go test), gait (dynamic gait index), and falls efficacy (falls efficacy scale-K) to confirm the effects of the intervention. [Results] Both the trampoline and the control group showed significant improvements in balance, gait, and falls efficacy compared to before the intervention, and the improvements were significantly greater in the trampoline group than in the control group. [Conclusion] Modified trampoline training resulted in significantly improved balance, dynamic gait, and falls efficacy of stroke patients compared to the control group. These results suggest that modified trampoline training is feasible and effective at improving balance, dynamic gait, and falls efficacy after stroke.

Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis: A systematic review

PubMed Central

Brito, Nayara Castelano; Rabello, Ana

2017-01-01

Background The mainstays of cutaneous leishmaniasis (CL) treatment, in several world regions, are pentavalent antimony (Sbv) compounds administered parenterally, despite their recognized toxicity, which requires frequent laboratory monitoring and complicates their use in areas with scarce infrastructure. As result of these drawbacks, the WHO Expert Committee on leishmaniasis has expanded the recommendations for the use of local therapies, including Sbv intralesional infiltration (IL-Sbv), as CL therapy alternatives even in the New World. However, the efficacy of these approaches has never been compiled. The aim of this study was to critically and systematically assess the efficacy of IL-Sbv for CL treatment. Methodology The PRISMA guidelines for systematic reviews and the Cochrane manual were followed. The sources used were the MEDLINE and LILACS databases and the International Clinical Trials Registry Platform of the World Health Organization. The outcome of interest was a clinical cure, defined as complete re-epithelialization of all lesions. The IL-Sbv pooled cure rate was estimated for several subgroups and direct comparisons were performed when possible. Results Thirty nine articles (40 studies) involving 5679 patients treated with IL-Sbv infiltration were included. In direct comparison, only three studies involving 229 patients compared IL-Sbv infiltration versus placebo and no difference was observed (OR: 1,9; 95%IC 0,93 to 3,82) based on cure rate 69.6% (95%CI 17.6–96.1%) and 83,2% (95%CI 66–92.7%) for placebo and IL-Sbv, respectively. In an alternative and non-comparative analysis, gathering all study arms using the intervention, the pooled IL-Sbv efficacy rate was 75% (95%CI 68–81%). In the Old World, the observed overall IL-Sbv efficacy rate was 75% (95%CI 66–82%), and the cure rates were significantly higher with sodium stibogluconate (SSG) than with meglumine antimoniate (MA): 83% (95%CI 75–90%) versus 68% (95%CI 54–79%), p = 0.03. Studies directly comparing IL-Sbv with topical 15% paromomycin ointment, IL hypertonic saline, radiofrequency-induced heat therapy, topical trichloroacetic acid and cryotherapy showed no significant difference in efficacy between the interventions. The analyses suggested a higher efficacy of IL-Sbv combined with cryotherapy (81.8%, 95%IC 62.4–92.4%) when compared with IL-Sbv alone (53.3%, 95%IC 46.1–66%), OR: 3.14 (95%CI 1.1–8.9), p = 0.03. In the New World, the global IL-Sbv efficacy was 77%(95%CI 66–85%). In contrast with the Old World, a significant difference favoring MA in relation to SSG was observed: 61% (95%CI 49–73%) versus 82% (95%CI 70–89%).By comparing IL infiltration schedules, it was determined that patients submitted to IL-Sbv treatments longer than 14 days had higher cure rates. Conclusions Despite the high heterogeneity and low methodological quality of studies, an indirect comparison shows that the antimony infiltration efficacy rate is similar to that reported for antimony systemic use. The evidence gathered thus far is insufficient to identify the ideal IL therapeutic regime or estimate the rates of adverse events and mucosal late complications. PMID:28926630

Efficacy and Safety of Citalopram Compared to Atypical Antipsychotics on Agitation in Nursing Home Residents With Alzheimer Dementia.

PubMed

Viscogliosi, Giovanni; Chiriac, Iulia Maria; Ettorre, Evaristo

2017-09-01

To assess efficacy and safety of citalopram compared to quetiapine and olanzapine for the treatment of agitation in patients with Alzheimer disease (AD). Longitudinal, 6-month study. Nursing home (NH). 75 NH residents with AD and agitation, randomized to citalopram (n = 25), quetiapine (n = 25), or olanzapine (n = 25). Changes in Neuropsychiatric Inventory (NPI) agitation subscale score and the modified Alzheimer Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC) were used to assess treatment efficacy. Participants were surveilled for adverse health outcomes. Citalopram treatment (30±5.8 mg/d) resulted in similar 6-month efficacy compared to both quetiapine (94.0±40.4 mg/d) and olanzapine (5.2±1.6 mg/d), lower occurrence of falls than olanzapine [odds ratio (OR) = 0.81, 95% confidence interval (CI) = 0.68-0.97, P = .012], lower incidence of orthostatic hypotension than both quetiapine (OR = 0.80, 95% CI = 0.66-0.95, P = .032) and olanzapine (OR = 0.75, 95% CI = 0.69-0.91, P = .02), and less all-cause hospitalizations than both quetiapine (OR = 0.92, 95% CI = 0.88-0.95, P = .016) and olanzapine (OR = 0.78, 95% CI = 0.64-0.92, P = .004), after multiple adjustment for potentially confounding variables. No differences were observed for cognitive and functional decline, QTc prolongation, and infections. Citalopram resulted in similar efficacy and less adverse outcomes when compared to 2 atypical antipsychotics for treatment of agitation in NH residents with AD. Replication of these findings and assessment of long-term efficacy and safety of citalopram for treatment of neuropsychiatric symptoms in dementia are needed. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Comparative assessment of the efficacy and safety of acarbose and metformin combined with premixed insulin in patients with type 2 diabetes mellitus

PubMed Central

Wu, Honghua; Liu, Jie; Lou, Qingqing; Liu, Jing; Shen, Li; Zhang, Mingxia; Lv, Xiaofeng; Gu, Mingjun; Guo, Xiaohui

2017-01-01

Abstract This study, a subgroup analysis of the data from the Organization Program of DiabEtes INsulIN ManaGement study, aimed to compare the efficacy and safety profiles of acarbose and metformin used in combination with premixed insulin. This analysis included 80 and 192 patients taking only 1 oral antidiabetic drug, classified into acarbose (treated with acarbose + insulin) and metformin groups (treated with metformin + insulin), respectively. The efficacy and safety data were analyzed for within- and between-group differences. The clinical trial registry number was NCT01338376. The percentage of patients who achieved target hemoglobin A1c (HbA1c) <7% in the acarbose and metformin groups were 38.75% and 30.73%, respectively, after a 16-week treatment. The average HbA1c levels in the acarbose and metformin groups were comparable at baseline and decreased significantly in both groups at the end of the study. All 7 blood glucose decreased significantly in both groups at endpoint compared with that at baseline. Insulin consumption was higher in the metformin group in terms of total daily amount and units/kg body weight. Incidences of hypoglycemia were similar in both groups. Body weight changed significantly in both groups from baseline to endpoint, but with no significant difference between the groups. Mean scores of Morisky Medication Adherence Scale improved in both groups at endpoint. Combination of insulin with acarbose or metformin could improve glycemic control in patients with type 2 diabetes mellitus. Acarbose and metformin were found to be comparable in terms of efficacy, weight gain, and incidence of hypoglycemia. PMID:28858080

Comparative assessment of the efficacy and safety of acarbose and metformin combined with premixed insulin in patients with type 2 diabetes mellitus.

PubMed

Wu, Honghua; Liu, Jie; Lou, Qingqing; Liu, Jing; Shen, Li; Zhang, Mingxia; Lv, Xiaofeng; Gu, Mingjun; Guo, Xiaohui

2017-09-01

This study, a subgroup analysis of the data from the Organization Program of DiabEtes INsulIN ManaGement study, aimed to compare the efficacy and safety profiles of acarbose and metformin used in combination with premixed insulin.This analysis included 80 and 192 patients taking only 1 oral antidiabetic drug, classified into acarbose (treated with acarbose + insulin) and metformin groups (treated with metformin + insulin), respectively. The efficacy and safety data were analyzed for within- and between-group differences. The clinical trial registry number was NCT01338376.The percentage of patients who achieved target hemoglobin A1c (HbA1c) <7% in the acarbose and metformin groups were 38.75% and 30.73%, respectively, after a 16-week treatment. The average HbA1c levels in the acarbose and metformin groups were comparable at baseline and decreased significantly in both groups at the end of the study. All 7 blood glucose decreased significantly in both groups at endpoint compared with that at baseline. Insulin consumption was higher in the metformin group in terms of total daily amount and units/kg body weight. Incidences of hypoglycemia were similar in both groups. Body weight changed significantly in both groups from baseline to endpoint, but with no significant difference between the groups. Mean scores of Morisky Medication Adherence Scale improved in both groups at endpoint.Combination of insulin with acarbose or metformin could improve glycemic control in patients with type 2 diabetes mellitus. Acarbose and metformin were found to be comparable in terms of efficacy, weight gain, and incidence of hypoglycemia.

Efficacy of iontophoresis-assisted ablative fractional laser photodynamic therapy with short incubation time for the treatment of actinic keratosis: 12-month follow-up results of a prospective, randomised, comparative trial.

PubMed

Choi, Seung-Hwan; Kim, Tae-Hoon; Song, Ki-Hoon

2017-06-01

Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic species across membranes and may have significant benefit for the treatment of actinic keratosis (AK) by ablative fractional laser-primed photodynamic therapy (AFL-PDT). The aims of this study were to compare the efficacy, recurrence rate, cosmetic outcome and safety of iontophoresis-assisted AFL-PDT with 2h of incubation vs. those of conventional AFL-PDT with 2- and 3-h incubation in patients with facial and scalp AK. Patients were randomly assigned to iontophoresis-assisted AFL-PDT with a 2-h incubation time (group A) and conventional AFL-PDT with a 2-h (group B) and 3-h (group C) incubation time. All patients underwent AFL-PDT, and group A patients were assigned to treatment with iontophoresis after methyl-aminolevulinate (MAL) application. After 2 or 3h, MAL-applied lesions were irradiated using a red light. Patients were followed up at 1-week, 3 months and 12 months after treatment. Efficacy, cosmetic outcomes and adverse events were assessed. In total, 41 patients (160 AK lesions) completed the study and were evaluated. Efficacy was significantly higher in Group A (88.7%) than in Group B (73.2%); the efficacy of groups A and C (92.2%) at 3 months follow-up was comparable. The recurrence rates were not significantly different between the groups at 12 months (P=0.841). The three groups did not differ in terms of cosmetic outcomes and safety. Iontophoresis-assisted AFL-PDT showed higher efficacy than AFL-PDT with short incubation time. Iontophoresis may effectively reduce the incubation time in AFL-PDT. Copyright © 2017 Elsevier B.V. All rights reserved.

Preventing necrotizing enterocolitis by food additives in neonates: A network meta-analysis revealing the efficacy and safety.

PubMed

Yu, Wentao; Sui, Wu; Mu, Linsong; Yi, Wenying; Li, Haijuan; Wei, Liqin; Yin, Weihong

2017-05-01

Necrotizing enterocolitis (NEC) is a serious multifactorial gastrointestinal disease which is often discovered in premature infants. Various additives have been used to prevent NEC; yet, their relative efficacy and safety remain disputed. This study aims to compare the efficacy and safety of 5 food additives, namely, probiotics, probiotics + fructo-oligosaccharides, pentoxifylline, arginine, and lactoferrin in preventing NEC in neonates. Embase, PubMed, and Cochrane Library had been searched for all eligible randomized control trials. Odds ratios (ORs) were estimated for dichotomous data and mean differences with 95% credible intervals (CrIs) were estimated for continuous data. Surface under the cumulative ranking curve was used to rank efficacy and safety of the prevention methods on each endpoint. A total of 27 eligible studies with 4649 preterm infants were included in this network meta-analysis (NMA), and the efficacy and safety of 5 food additives were evaluated. Probiotic and arginine exhibited better preventive efficacy compared with placebo (OR = 0.50, 95% CrIs: 0.32-0.73; OR = 0.30, 95% CrIs: 0.12-0.73, respectively). Only probiotic achieved a considerable decrease in the risk of mortality compared to placebo (OR = 0.68, 95% CrIs: 0.46-0.98). NEC patients with lactoferrin appeared to have lower incidence of sepsis than those of placebo (OR = 0.13, 95% CrIs: 0.03-0.61) or probiotic (OR = 0.18, 95% CrIs: 0.03-0.83). Based on this NMA, probiotics had the potential to be the most preferable additive, since it exhibited a significant superiority for NEC and mortality as well as a relatively balanced performance in safety.

Knock-down and speed of kill of a combination of fipronil and permethrin for the prevention of Ctenocephalides felis flea infestation in dogs.

PubMed

Halos, Lénaïg; Fourie, Josephus J; Fankhauser, Becky; Beugnet, Frederic

2016-02-02

A topical combination of fipronil + permethrin (Frontline Tri-Act/Frontect, Merial) has recently been developed to control fleas, ticks, mosquitoes, sandflies and stable flies on dogs. Two studies were conducted to assess its speed of kill and knock-down effect on Ctenocephalides felis fleas. The combination was compared to either fipronil alone or to a combination of permethrin, dinotefuran, and pyriproxyfen, In each study, 18 dogs were randomly allocated to one of three groups: (Group 1: untreated dog; Group 2: treated once on D0 with the combination of fipronil and permethrin; Group 3: treated once on D0 either with fipronil alone (study 1) or with a combination of permethrin, dinetofuran and pyriproxyfen (study 2)). Each dog was infested with 100 unfed adult C. felis fleas on Days 2 (study 2), 7, 14, 21 and 28. Fleas were collected from dogs at 1 h and 12 h post- infestations (PI) (study 1) or at 2 h and 6 h PI (study 2) to assess efficacy and from collection pans underneath cages 1 h (study 1) or 5 min (study 2) PI to assess knock-down effect. All treated dogs had significantly (p ≤ 0.01) lower flea counts than untreated dogs at every time point in both studies. For a whole month, a significant knock-down effect against infesting fleas is obtained in five minutes PI with the combination of permethrin and fipronil. Complete efficacy (>95%) was achieved in 1 h (study 1) or 2 h (study 2) PI for 14 days and by 6 h PI for all challenges conducted throughout the month. Efficacy remains >85% at 2 h PI for the whole month. A significantly higher efficacy of the fipronil + permethrin combination compared to other treatments was demonstrated at the earliest time points for the month (1 h knock-down effect and insecticidal efficacy compared to fipronil alone; 5 min knock-down effect compared to the combination of permethrin + dinetofuran + pyriproxyfen). The rapid flea knock-down effect and speed of kill demonstrated by the spot on combination of fipronil + permethrin provide a reliable strategy against flea infestations in dogs.

Efficacy of high doses of levofloxacin in experimental foreign-body infection by methicillin-susceptible Staphylococcus aureus.

PubMed

Murillo, O; Doménech, A; Garcia, A; Tubau, F; Cabellos, C; Gudiol, F; Ariza, J

2006-12-01

Antimicrobial efficacy in orthopedic device infections is diminished because of bacterial biofilms which express tolerance to antibiotics. Recently, the use of high doses of levofloxacin with rifampin has been recommended for staphylococcal infections. In the present study, we evaluated the efficacy of levofloxacin at doses of 50 mg/kg/day and 100 mg/kg/day (mimicking the usual and high human doses of 500 mg/day and 750 to 1,000 mg/day, respectively) and compared it to that of to linezolid, cloxacillin, vancomycin, and rifampin in a rat tissue cage model of experimental foreign-body infection by Staphylococcus aureus. The antimicrobial efficacy in vitro (by MIC, minimum bactericidal concentration, and kill curves) for logarithmic- and stationary-phase bacteria was compared with the in vivo efficacy. In vitro bactericidal activity at clinically relevant concentrations was reached by all drugs except rifampin and linezolid in the log-phase studies but only by levofloxacin in the stationary-phase studies. The bacterial count decreases from in vivo tissue cage fluids (means) for levofloxacin at 50 and 100 mg/kg/day, rifampin, cloxacillin, vancomycin, linezolid, and controls, respectively, were: -1.24, -2.26, -2.1, -1.56, -1.47, -1.15, and 0.33 (all groups versus controls, P < 0.05). Levofloxacin at 100 mg/kg/day (area under the concentration-time curve/MIC ratio, 234) was the most active therapy (P = 0.03 versus linezolid). Overall, in vivo efficacy was better predicted by stationary-phase studies, in which it reached a high correlation coefficient even if the rifampin group was excluded (r = 0.96; P < 0.05). Our results, including in vitro studies with nongrowing bacteria, pharmacodynamic parameters, and antimicrobial efficacy in experimental infection, provide good evidence to support the use of levofloxacin at high doses (750 to 1,000 mg/day), as recently recommended for treating patients with orthopedic prosthesis infections.

Efficacy of aspiration in amebic liver abscess.

PubMed

Ghosh, Jayant Kumar; Goyal, Sundeep Kumar; Behera, Manas Kumar; Tripathi, Manish Kumar; Dixit, Vinod Kumar; Jain, Ashok Kumar; Shukla, Ramchandra

2015-01-01

Amebic liver abscess (ALA) is a common and serious problem in our country. There are only a few controlled trials on the efficacy and advantages of combination therapy with percutaneous needle aspiration and pharmacotherapy, over pharmacotherapy alone for amebic liver abscess. This study was conducted to compare the efficacy of two different treatment modalities i.e. drug treatment alone vs. drug treatment and aspiration of abscess cavity in patients with small (up to 5 cm) and large (5 cm to 10 cm) size ALA. This is one of the largest single center, prospective, randomized studies comparing the efficacy of aspiration in ALA. (i) Mean body temperature, liver tenderness, total leukocyte count (TLC), serum alanine aminotransferase (ALT) and liver span were significantly decreased in the aspiration group on days 8 and 15 as compared to non-aspiration group especially in large abscess (5 cm to 10 cm). (ii) Abscess cavity maximum diameter decreased significantly in aspiration group on days 8 and 15, and 1 month & 3 months in large abscess (5cm to 10 cm). (i) Needle aspiration along with metronidazole hastens clinical improvement especially in large (5 cm up to 10 cm) cavities in patients with ALA. (ii) Aspiration is safe and no major complications occurred. (iii) Hence, combination therapy should be the first choice especially in large ALA (5 cm to 10 cm).

Influence of students' STEM self-efficacy on STEM and physics career choice

NASA Astrophysics Data System (ADS)

Halim, Lilia; Rahman, Norshariani Abd; Ramli, Nor Aidillina Mohd; Mohtar, Lilia Ellany

2018-01-01

Interest towards STEM and STEM careers is declining worldwide. Among the STEM related careers, the physics discipline has been the most affected in terms of numbers and imbalance of gender. This study investigates the role of self-efficacy in STEM towards STEM careers and Physics career based on gender and types of school. Findings showed that there is a positive and significant correlation between students' STEM self-efficacy and interest towards all disciplines in STEM and Physics career. Boys showed high level of self-efficacy in engineering discipline while the girls' associate more with science. Students from boarding schools showed higher self-efficacy and interest towards STEM careers compared to students from public schools. An implication of the study is that self-efficacy and interest in STEM careers are enhanced through engagement with STEM activities in and outside of school. Emphasis should be given to the role of counselors in making STEM careers relevant to students.

Relationship between critical thinking disposition and teaching efficacy among special education integration program teachers in Malaysia

NASA Astrophysics Data System (ADS)

Sulaiman, Tajularipin; a/l Kuppusamy, Suresh Kumar; Ayub, Ahmad Fauzi Mohd; Rahim, Suzieleez Syrene Abdul

2017-01-01

This study aims to assess the level of critical thinking disposition and teaching efficacy among the Special Education Integration Programme (SEIP) teachers in Negeri Sembilan, Malaysia. The level of critical thinking dispositions and teaching efficacy in the SEIP were compared based on teaching experience and gender. The study also examined the relationship between critical thinking disposition and teaching efficacy at SEIP. The research adopted a quantitative survey approach. A total of 190 primary school teachers from the SEIP in Negeri Sembilan were selected using proportional sampling method. The instrument used in this study comprised of three sections; demography, critical thinking disposition and teaching efficacy. Descriptive and inferential statistics were used in the analysis. Analysis shows that the respondents have a moderate level of critical thinking disposition (M = 2.99, S.D = 0.160) and teaching efficacy (M = 3.01 S.D. = 0.128) was at a high level. For teaching experience, the analysis showed that thinking disposition of novice teachers (mean = 2.52, SD = .503) are significantly higher than experienced teachers (mean = 2.35, SD = .481, t = 2.244, p <.05). There was no significant difference between male and female SEIP teachers in critical thinking disposition and teaching efficacy. Findings also indicated that there is a significant positive moderate relationship (r = .477) between critical thinking disposition and teaching efficacy among SEIP teachers. This study suggests that critical thinking disposition and teaching efficacy play an important role to enhance the performance of SEIP teachers.

A comparative efficacy study of photic driving brainwave entrainment technology with a novel form of more direct entrainment

NASA Astrophysics Data System (ADS)

Knowles, Richard Thomas

This exploratory study compared the efficacy of a novel brainwave electromagnetic (EM) entrainment technology against a more conventional technology utilizing the photic-driving technique. Both experimental conditions were also compared with a 7-minute control session that took place immediately before each stimulation session. The Schumann Resonance (SR) frequency was selected as the delivery signal and was chosen because of previous findings suggesting that entrainment to this frequency can often produce transpersonal if not paranormal, experiences in the entrainee, which sometimes resemble remote viewing or out-of-body experiences. A pilot study determined which of two novel entrainment modalities (a copper coil or a 16-solenoid headset) worked most effectively for use with the rest of the study. In the main study, an artificial SR signal at 7.8Hz was delivered during the photic-driving sessions, but a recording of the real-time SR was used to deliver the entrainment signal during sessions devoted to the electromagnetic entrainment modality. Sixteen participants were recruited from the local area, and EEG recordings were acquired via a 32-channel Deymed electroencephalography system. Comparative analyses were performed between the control and experimental portions of each session to assess for efficacy of the novel entrainment modality used, and, in the main study, between the electromagnetic and photic-driving sessions, to assess for differential entrainment efficacy between these groups. A follow-up study was additionally performed primarily to determine whether responders could replicate their entrainment effect from the main study. Results showed that EM entrainment appeared to be possible but is not nearly as robust or reliable as photic driving. Additionally, no profound transpersonal or paranormal experiences were elicited during the course of the study, and, when asked, participants were not able to determine with any degree of success, when the stimulation coil was turned on or off.

The efficacy of oral non-steroidal anti-inflammatory drugs for rotator cuff tendinopathy: a systematic review and meta-analysis.

PubMed

Boudreault, Jennifer; Desmeules, François; Roy, Jean-Sébastien; Dionne, Clermont; Frémont, Pierre; Macdermid, Joy C

2014-04-01

To conduct a systematic review and meta-analysis on the efficacy of oral non-steroidal anti-inflammatory drugs for rotator cuff tendinopathy. Systematic review. A literature search was conducted in 4 databases for randomized controlled trials published until 05/2013, comparing the efficacy of oral anti-inflammatory drugs to any other intervention. Studies characteristics were extracted using a standardized form and the methodological quality was evaluated. Results were summarized qualitatively or quantitatively. The mean methodological score of the 12 included studies was 53.6 ± 8.8%. The majority of studies included acute cases and were underpowered to detect differences in adverse events. Compared to a placebo, oral non-steroidal anti-inflammatory drugs were found to provide short-term pain relief (pooled mean difference: -2.69; 95% confidence interval: -1.96 to -3.41) but not function. Oral anti-inflammatory- drugs and corticosteroids injections have similar short-term efficacy in terms of pain reduction as well as in function (pooled standardized mean difference: 0.09; 95% confidence interval: -0.25 to 0.44). Low to moderate grade evidence exists regarding the efficacy of non-steroidal anti-inflammatory drugs for rotator cuff tendinopathy. Oral anti-inflammatory drugs are effective in reducing short-term pain but not function. In terms of pain and function, oral anti-inflammatory drugs in the short term are as effective as corticosteroid injections.

Expected and perceived efficacy of complementary and alternative medicine: A comparison views of patients with cancer and oncologists.

PubMed

Kim, Sang Hyuck; Shin, Dong Wook; Nam, You-Seon; Kim, So Young; Yang, Hyung-Kook; Cho, Be Long; Park, Keeho; Jo, Heui-Sug; Yim, Chang-Yeol; Kam, Sin; Park, Jong-Hyock

2016-10-01

This study sought to identify discrepancies between the expectations of patients with cancer and oncologists regarding the efficacy of complementary and alternative medicines (CAMs), and to determine how patients evaluate CAM efficacy after its use. Data from the Cancer Patient Experience Study, a nationwide survey, were used. Seven subdivided efficacy domains were included in the survey. An oncologist-patient matching analysis was done to assess the concordance of CAM efficacies between oncologists and patients with cancer. In addition, the patients' expectations of CAM efficacies were compared before and after use. Out of 719 participants, 201 patients with cancer (28.0%) reported using CAMs. The patients with cancer generally tended to be more positive about CAM efficacies than the oncologists. The largest discrepancy in efficacy perception was found in the efficacy domain of survival benefit, which included complete disease remission and prolonged survival. Many patients reported that they did not experience the positive efficacy they had anticipated before use. However, a substantial proportion of patients indicated that CAMs were as effective as they had expected, even though there is little evidence supporting the CAM efficacies. There was a marked discrepancy and a lack of concordance in expectations of CAM efficacy between patients with cancer and oncologists. Better communication between the patients and oncologists regarding CAM efficacy would be needed to make the patients to have shared expectations, and to reduce unnecessary CAM use. Copyright © 2016. Published by Elsevier Ltd.

Sweat Therapy Theory, Practice, and Efficacy

ERIC Educational Resources Information Center

Eason, Allen; Colmant, Stephen; Winterowd, Carrie

2009-01-01

The purpose of this article is to examine the potential application of sweat rituals to group counseling, adventure therapy, and other forms of group work by describing a theoretical model for how sweat rituals work and presenting the results of a randomized comparative outcome study on the efficacy of sweat therapy. The theoretical model proposes…

Efficacy and Safety of Dexmethylphenidate Extended-Release Capsules in Children with Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Greenhill, Laurence L.; Muniz, Rafael; Ball, Roberta R.; Levine, Alan; Pestreich, Linda; Jiang, Hai

2006-01-01

Objective: The efficacy and safety of dexmethylphenidate extended release (d-MPH-ER) was compared to placebo in pediatric patients with attention-deficit/hyperactivity disorder (ADHD). Method: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, two-phase study included 97 patients (ages 6-17 years) with…

Efficacy of Pharmacist Based Diabetes Educational Interventions on Clinical Outcomes of Adults With Type 2 Diabetes Mellitus: A Network Meta-Analysis

PubMed Central

Bukhsh, Allah; Khan, Tahir M.; Lee, Shaun W. H.; Lee, Learn-Han; Chan, Kok-Gan; Goh, Bey-Hing

2018-01-01

Background: Comparative efficacy of different pharmacist based interventions on glycemic control of type 2 diabetes patients is unclear. This review aimed to evaluate and compare the efficacy of different pharmacist based interventions on clinical outcomes of type 2 diabetes patients. Methods: A systematic search was conducted across five databases from date of database inception to September 2017. All randomized clinical trials evaluating the efficacy of pharmacist based interventions on type 2 diabetes patients were included for network meta-analysis (NMA). The protocol is available with PROSPERO (CRD42017078854). Results: A total of 43 studies, involving 6259 type 2 diabetes patients, were included. NMA demonstrated that all interventions significantly lowered glycosylated hemoglobin (HbA1c) levels compared to usual care, but there was no statistical evidence from this study that one intervention was significantly better than the other for reducing HbA1c levels. Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy for reducing HbA1c levels [−0.86, 95% CI −0.983, −0.727; p < 0.001]. Pharmacist based diabetes education plus pharmaceutical care was observed to be statistically significant in lowering levels of systolic blood pressure [−4.94; 95%CI −8.65, −1.23] and triglycerides levels [−0.26, 95%CI −0.51, −0.01], as compared to the interventions which involved diabetes education by pharmacist, and for body mass index (BMI) [−0.57; 95%CI −1.25, −0.12] in comparison to diabetes education by health care team involving pharmacist as member. Conclusion: The findings of this review demonstrate that all interventions had a significantly positive effect on HbA1c, but there was no statistical evidence from this study that one intervention was significantly better than the other for achieving glycemic control.Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy on HbA1c and rest of the clinical outcomes. PMID:29692730

Postural control and balance self-efficacy in women with fibromyalgia: are there differences?

PubMed

Muto, L H A; Sauer, J F; Yuan, S L K; Sousa, A; Mango, P C; Marques, A P

2015-04-01

Fibromyalgia (FM) is a rheumatic disease characterized by chronic widespread pain and symptoms such as fatigue, sleep disturbances, cognitive difficulties, and depression. Postural instability is a debilitating disorder increasingly recognized as part of FM. To assess and compare postural control and balance self-efficacy in women with and without FM and verify the association of these variables with pain, symptom severity, and strength. Case-control study Physiotherapeutic Clinical Research and Electromyography Laboratory Department of Physical Therapy, Speech Therapy, and Occupational Therapy, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil. Case-control study of 117 women ranging from age 35 to 60 years. Of these, 67 had FM. Posture control was assessed with the modified clinical test of sensory interaction on balance with patients in forceplates, balance self-efficacy with the Activities-specific Balance Confidence Scale, pain severity with the Visual Analog Scale, tender point pain threshold with digital algometry, symptom severity with the fibromyalgia impact questionnaire, and lower limb strength with a dynamometer. Individuals with FM had impaired postural control showing increased speed of oscillation of the center of gravity (P=0.004) and decreased balance self-efficacy (P<0.001). They had moderate to excellent correlations of balance self-efficacy with pain (r=0.7, P<0.01), muscle strength (r=0.52, P<0.01), and symptom severity (r=0.78, P<0.10) compared with the control group. Correlation of postural control with the same variables was weak. Patients with FM have impaired postural control and low balance self-efficacy that are associated with pain, muscle strength, and symptom severity. Postural control and balance self-efficacy needs to be assessed in patients with FM and the treatment goals should be the improvement of postural control and balance self-efficacy.

Gender differences in determinants of condom use among HIV clients in Uganda.

PubMed

Walusaga, Happy Annet; Kyohangirwe, Rossette; Wagner, Glenn J

2012-11-01

Little research has examined gender differences in reporting of condom use, which is the goal of our analysis. A baseline study was conducted in two urban clinics and we examined data from sexually active clients entering HIV care who enrolled in a prospective longitudinal cohort study. The primary outcome was consistent condom use and determinant variables were demographics, physical health and immune status, economic well-being, relationship characteristics, psychosocial functioning, and self-efficacy. Of 280 participants, 129 were males and 151 females, and 41.7% had at least some secondary education; 60.7% did not always use condoms. Nearly half (48.1%) of men reported always using condoms compared to 31.8% of females. In bivariate analyses, men who consistently use condoms were more likely to be working, have a primary partner who was HIV negative, to have disclosed their HIV status to their primary partner, and to have higher general self-efficacy and condom use self-efficacy compared to men who did not always use condoms. Higher general self-efficacy and condom use self-efficacy were the only variables associated with reported consistent condom use among women. In regression analysis, working in the last 7 days, general self efficacy, and condom use self-efficacy were associated with consistent condom use among men. These findings reveal low rates of consistent condom use among people living with HIV, and a gender difference with men more likely to report consistent condom use. These data suggest the need for gender sensitive prevention programs and strategies, including programs that can provide women with greater control and self-efficacy regarding use of protective methods.

Does the use of efficacy or effectiveness evidence in cost-effectiveness analysis matter?

PubMed

Dilokthornsakul, Piyameth; Chaiyakunapruk, Nathorn; Campbell, Jonathan D

2017-01-02

To test the association of clinical evidence type, efficacy-based or effectiveness-based ("E"), versus whether or not asthma interventions' cost-effectiveness findings are favorable. We conducted a systematic review of PubMed, EMBASE, Tufts CEA registry, Cochrane CENTRAL, and the UK National Health Services Economic Evaluation Database from 2009 to 2014. All cost-effectiveness studies evaluating asthma medication(s) were included. Clinical evidence type, "E," was classified as efficacy-based if the evidence was from an explanatory randomized controlled trial(s) or meta-analysis, while evidence from pragmatic trial(s) or observational study(s) was classified as effectiveness-based. We defined three times the World Health Organization cost-effectiveness willingness-to-pay (WTP) threshold or less as a favorable cost-effectiveness finding. Logistic regression tested the likelihood of favorable versus unfavorable cost-effectiveness findings against the type of "E." 25 cost-effectiveness studies were included. Ten (40.0%) studies were effectiveness-based, yet 15 (60.0%) studies were efficacy-based. Of 17 studies using endpoints that could be compared to WTP threshold, 7 out of 8 (87.5%) effectiveness-based studies yielded favorable cost-effectiveness results, whereas 4 out of 9 (44.4%) efficacy-based studies yielded favorable cost-effectiveness results. The adjusted odds ratio was 15.12 (95% confidence interval; 0.59 to 388.75) for effectiveness-based versus efficacy-based achieving favorable cost-effectiveness findings. More asthma cost-effectiveness studies used efficacy-based evidence. Studies using effectiveness-based evidence trended toward being more likely to disseminate favorable cost-effective findings than those using efficacy. Health policy decision makers should pay attention to the type of clinical evidence used in cost-effectiveness studies for accurate interpretation and application.

Efficacy and safety of selective glucocorticoid receptor modulators in comparison to glucocorticoids in arthritis, a systematic review.

PubMed

Safy, M; de Hair, M J H; Jacobs, J W G; Buttgereit, F; Kraan, M C; van Laar, J M

2017-01-01

Long-term treatment with glucocorticoids (GCs) plays an important role in the management of arthritis patients, although the efficacy/safety balance is unfavorable. Alternatives with less (severe) adverse effects but with good efficacy are needed. Selective GC receptor modulators (SGRMs) are designed to engage the GC receptor with dissociative characteristics: transactivation of genes, which is mainly responsible for unwanted effects, is less strong while trans-repression of genes, reducing inflammation, is maintained. It is expected that SGRMs thus have a better efficacy/safety balance than GCs. A systematic review providing an overview of the evidence in arthritis is lacking. To systematically review the current literature on efficacy and safety of oral SGRMs in comparison to GCs in arthritis. A search was performed in Medline, Embase and the Cochrane Library, from inception dates of databases until May 2017. Experimental studies involving animal arthritis models or human material of arthritis patients, as well as clinical studies in arthritis patients were included, provided they reported original data. All types of arthritis were included. Data was extracted on the SGRM studied and on the GC used as reference standard; the design or setting of the study was extracted as well as the efficacy and safety results. A total of 207 articles was retrieved of which 17 articles were eligible for our analysis. Two studies concerned randomized controlled trials (RCT), five studies were pre-clinical studies using human material, and 10 studies involved pre-clinical animal models (acute and/or chronic arthritis induced in mice or rats). PF-04171327, the only compound investigated in a clinical trial setting, had a better efficacy/safety balance compared to GCs: better clinical anti-inflammatory efficacy and similar safety. Studies assessing both efficacy and safety of SGRMs are scarce. There is limited evidence for dissociation of anti-inflammatory and metabolic effects of the SGRMs studied. Development of many SGRMs is haltered in a preclinical phase. One SGRM showed a better clinical efficacy/safety balance.

Nivel de Actividad Física, Autoeficacia, Beneficios y Barreras Percibidas en Mujeres Mayores Mexicanas Independientes (Physical Activity Level, Exercise Self-Efficacy, Benefits and Perceived Barriers of Independent Mexican Older Women).

PubMed

Enríquez-Reyna, María Cristina; Cruz-Castruita, Rosa María; Zamarripa, Jorge; Ceballos-Gurrola, Oswaldo; Guevara-Valtier, Milton Carlos

2016-03-01

This descriptive comparative study examined differences in personal characteristics, exercise self-efficacy, benefits and barriers of independent elderly women to perform physical activity (PA) according with the PA level. Two hundred three women older than 60 years of age, from a community located in Nuevo Leon, Mexico participated in the study. Data was collected using: a) A personal data questionnaire, b) Exercise Self-Efficacy Scale, c) Exercise Benefits/ Barriers Scale and d) Physical Activity Scale for the Elderly were completed. Age was similar in participants with low and acceptable PA level. Participants with lower levels of PA reported consuming more medications, fewer years of education and lower values of exercise self-efficacy, benefits and barriers. In this sample, exercise self-efficacy and benefits were positively associated with the PA level. © 2016. All rights reserved.

Efficacy of Botulinum toxin A for the treatment of Bladder pain syndrome: A systematic review.

PubMed

Ochoa Vargas, D C; García Perdómo, H A

2018-04-01

To determine the efficacy and safety of BTX-A, compared with other interventions for the treatment of BPS to improve quality of life. This systematic review fulfils all the requirements of the Cochrane manual and PRISMA reporting guidelines. The PROSPERO registration number is: CRD42016039480.Clinical trials without language discrimination were included. BPS patients over 18 y/o that were treated with BTX-A were included. Studies were searched in published databases and no published literature from inception to the present day. Risk of bias analysis was done using the Cochrane risk of bias tool. 88 articles were found with the designed search strategies. After exclusions, four studies were included in the qualitative analyses. Kasyan et al., 2012 compared BTX-A with hydrodistention. Manning et al., 2014 compared the injection of BTX-A with the injection of normal saline in previously hydrodistended bladders. In both cases, primary end point was measured by the O'Leary-Sant questionnaire score. El-Bahnasy et al., 2009 compared BTX-A with BCG administration, through Global Response Assessment. Kuo et al., 2015 compared hydrodistention plus suburothelial injections of BTX-A with hydrodistension plus normal saline injections. Reduction in pain was estimated by VAS bladder pain score. A similar efficacy to their controls had been found in Kasyan and Manning studies. El-Bahnasy had found improvement in BTX-A in all parameters. Kuo el al. 2015, found a significantly reduction in pain in the BTX-A group. Regarding the risk of bias, three studies did not have adequate descriptions of selection, performance and detection bias. The study of Manning had low risk of selection, attrition and reporting bias. There is not enough evidence to conclude the efficacy of BTX-A for the treatment of interstitial cystitis to improve quality of life. Copyright © 2017 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

[Comparative efficacy of two topical formulations containing 10% fipronil on the control of Ctenocephalides felis felis on cats].

PubMed

Tancredi, Michelle Godan de Freitas; Correia, Thaís Ribeiro; Ribeiro, Francisco de Assis; Botelho, Maria Clara da Silva Negreiros; Tavares, Pedro Vianna; Scott, Fabio Barbour; Verocai, Guilherme Gomes; Coumendouros, Katherina

2009-01-01

The goal of the present study was to evaluate the comparative efficacy of two topical formulations containing 10% fipronil on the control of Ctenocephalides felis felis on cats. The trial was performed at the Laboratory of Experimental Chemotherapy in Veterinary Parasitology from the Department of Animal Parasitology of the Institute of Veterinary of the Universidade Federal Rural do Rio de Janeiro. Eighteen mixed-breed cats were divided in three groups of six animals each. One group remained without treatment (control). The other groups received as treatment the two topical formulations, a commercial reference and the novel one, both containing 10% fipronil. Treated animals received 0.5 mL of product along their cervical region. Cats were infested on days - 2, +5, +12, +19, +26 and +33. Evaluations were made using the "comb test". The first one was undertaken 4 days after the initial infestation (day +2), and others 48 hours after following infestations (days +7, +14, +21, +28 and + 35). Both tested formulations had satisfactory efficacy until day + 35. No differences were observed comparing the efficacy levels between both formulations throughout the experimental period. The novel topical 10% fipronil formulation presented desirable efficacy on the control of C. f. felis on cats.

Efficacy of a standardized herbal preparation (Roidosanal®) in the treatment of hemorrhoids: A randomized, controlled, open-label multicentre study

PubMed Central

Aggrawal, Kapil; Satija, Naveen; Dasgupta, Gita; Dasgupta, Partha; Nain, Parul; Sahu, Aditya R.

2014-01-01

Background: Catechins and epicatechins are monomers of naturally occurring proanthocyanidins, which have been reported with free radical scavenging, antioxidant, antiinflammatory, antiallergic, and vasodilatory properties. Plant parts rich in proanthocyanidins have been used for years in treatment of various ano-rectal diseases. This study compares the efficacy of two herbal preparations, Daflon® 500 mg and Roidosanal®, in ameliorating the signs and symptoms associated with hemorrhoids. Objective: To evaluate the safety and to compare the efficacy of a herbal preparation, Roidosanal® versus Daflon® 500 mg, on signs and symptoms of hemorrhoidal disease. Materials and Methods: In this pilot, active controlled, open-labeled multicentre study, 73 patients with proctoscopy proven hemorrhoids (Grade I to III) were randomly assigned to receive either Roidosanal® (Gr R; n = 37) or Daflon® 500 mg (Gr D; n = 36), for 15 days, at three centers in India. Assessment of hemorrhoidal symptoms was carried out in all patients at different time points. Intent-to-treat analysis was performed for both primary and secondary endpoints. Results: Baseline characteristics were comparable between the two groups. Both products were found to be equally effective in improving the ano-rectal conditions in Grade I and Grade II hemorrhoids; however, Roidosanal® demonstrated better efficacy in patients with Grade III hemorrhoids. Hemorrhoids associated symptoms like bleeding, pain, etc., improved in both groups, although intergroup comparisons were comparable. Conclusion: Both Roidosanal® and Daflon® 500 mg were equally effective in resolving signs and symptoms of hemorrhoids. Roidosanal® can be tried as a safe and effective treatment option for treatment of hemorrhoids. Further randomized, double-blind and large multicentre studies are recommended. PMID:24948863

Fenoterol hydrobromide delivered via HFA-MDI or CFC-MDI in patients with asthma: a safety and efficacy comparison.

PubMed

Goldberg, J; Böhning, W; Schmidt, P; Freund, E

2000-10-01

The main objective of the study was to compare the long-term safety and tolerability of fenoterol hydrobromide delivered using a metered-dose inhaler formulated with the alternative propellant, hydrofluoroalkane 134a (HFA-MDI), with delivery using the currently available chlorofluorocarbon MDI (CFC-MDI; Berotec 100). A further objective was to compare the efficacy of fenoterol HFA-MDI with fenoterol CFC-MDI, using the pulmonary function parameters of forced expiratory volume in 1 sec (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF). Following a 2-week run-in phase, a 12-week, double-blind parallel group comparison was undertaken in 290 patients randomized on a 2:1 basis to two puffs of 100 microg fenoterol four times a day (HFA-MDI=197 patients; CFC-MDI=93 patients). A total of 236 patients in this multi-centre study completed the trial as planned. The overall incidence of adverse events (AEs) was similar in both groups (29.9% of HFA-MDI patients and 28% of CFC-MDI patients). Reports of respiratory disorder AEs were also comparable (21.8% HFA-MDI; 22.6% CFCMDI). End of study laboratory tests, ECG, pulse, blood pressure and physical examination showed no significant differences from pre-study baselines in either group and both treatments appeared to be well tolerated. Pre-dose FEV1 measurements taken at the three clinic visits were constant and increase in FEV1 at 5 and 30 min post-dose demonstrated equivalent efficacy for the two formulations. No difference between the two groups was observed in PEF or in the use of rescue medication. We conclude from these findings that the long-term safety and efficacy profile of fenoterol HFA-MDI is comparable to that of the fenoterol CFC-MDI.

The efficacy beliefs of preservice science teachers in professional development school and traditional school settings

NASA Astrophysics Data System (ADS)

Newsome, Demetria Lynn

Teachers' efficacy beliefs have been shown to correlate positively with to the successful implementation of science reform measures (National Research Council, 1996) and are context specific (Koul & Rubba, 1999). Studies on teacher efficacy in specific contexts have been conducted including the availability of resources and parent support (Tschannen-Moran & Hoy, 2002), classroom management (Emmer & Hickman, 1990; Raudenbush, Rowen, & Cheong, 1992); and institutional climate and behavior of the principal (Hoy & Woolfolk, 1993). The purpose of this study was to compare the science teaching efficacy beliefs of teacher interns prepared in professional development schools with those of student teachers prepared in traditional school settings. Other variables examined included academic level, academic major, and area of science concentration. Preservice science teacher efficacy beliefs were measured using the Science Teaching Efficacy Beliefs Instrument for Preservice Science Teachers, STEBI Form B (Enoch & Riggs, 1990) with demographic information being collected by an accompanying questionnaire. Analyses included scoring the surveys on two scales, Personal Science Teaching Efficacy Beliefs Scale and the Outcome Expectancy Scale, calculating descriptive statistics, as well as performing MANOVAS and correlations. Results indicate that preservice science teachers working in professional development schools exhibit higher personal science teaching efficacy beliefs. This finding corroborates previous studies on the efficacy beliefs of preservice teachers working in PDS schools (Long, 1996; Sandholtz & Dadlez, 2000). Results also show a strong correlation between the personal science teaching efficacy beliefs and the setting where student teaching takes place. In addition, significant differences were found in the personal science teaching efficacy beliefs between elementary education majors and science majors, science education majors, and secondary education majors. Findings of the study have implications for the design of preservice science teacher clinical experiences including providing longer, organized clinical experiences and preferential selection of preservice science teachers for PDS practicum assignments.

Feasibility of extended use of an electromagnetic lithotripter beyond the manufacturer's recommended maintenance schedule.

PubMed

Chen, Tony Y H; Ponsot, Yves; Brouillette, Martin; Tétrault, Jean-Píerre; Tu, Le Mai

2007-06-01

The study evaluates the effect of chronic usage, beyond the recommended maintenance schedule, on the efficacy of electromagnetic lithotripter. To our knowledge, there is no publication investigating the effect of chronic usage on the electromagnetic lithotripter, despite the maintenance schedule established by the manufacturers. Our goal is to verify if the acoustic parameters of the shock wave changed with usage, and if this change could be associated with change in clinical efficacy. This study lasted 18 months. Every 6 months the lithotripter's efficacy was evaluated in two ways: objectively and clinically. Objective efficacy was measured using a piezoelectric hydrophone and artificial stones to capture the acoustic parameters and the crater of fragmentation, respectively. Clinical efficacy data was collected by studying the rate of successful extracorporeal shock wave lithotripsy treatment in patients with urolithiasis. The changes in clinical efficacy, acoustic parameters, and craters of fragmentation were compared and analyzed with appropriate statistical methods. Five hundred twenty five patients participated in the study. The clinical efficacy remained stable throughout the three observation periods (55.7%, 66.2% and 55.5%; p = 0.11). The focal head of the lithotripter was used three times the recommended schedule. There was no obvious change in the acoustic parameters of the shock waves, and the focal zone remained stable. The clinical efficacy of the electromagnetic lithotripter appears to be stable despite usage beyond the recommended maintenance schedule. More studies are needed to validate the safety of this practice.

In vivo cleansing efficacy of biodegradable exfoliating beads assessed by skin bioengineering techniques.

PubMed

Kitsongsermthon, J; Duangweang, K; Kreepoke, J; Tansirikongkol, A

2017-11-01

The plastic microbeads, used in many cleansers, will be banned in cosmetic and personal care products within 2017 since they are non-degradable and can disturb the living organisms in water reservoirs. Various choices of biodegradable beads are commercially available, but their efficacy has not been proven yet. This study aimed to compare the cleansing efficacy in dirt and sebum removal aspects of three types of exfoliating beads. The gel scrubs with polyethylene (PE) beads, mannan beads or wax beads, were formulated and evaluated for their stability. The in vivo evaluation was done in 38 healthy volunteers and the skin irritation, efficacy for dirt and sebum removal were measured by Mexameter ® , Colorimeter ® , and Sebumeter ® , respectively. The selected gel scrubs did not cause an irritation in any volunteers. The differences in dirt residues between before and after scrubbing were not statistically significant among three gel scrubs and the similar result was also reported in the sebum removal study. All gel scrubs demonstrated the comparable cleansing efficacy in term of dirt and sebum removal. Thus, mannan beads and wax beads may be replaced non-biodegradable PE beads to achieve the similar cleansing effect. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Drug delivery systems for ovarian cancer treatment: a systematic review and meta-analysis of animal studies

PubMed Central

Raavé, René; de Vries, Rob B.M.; Massuger, Leon F.; van Kuppevelt, Toin H.

2015-01-01

Current ovarian cancer treatment involves chemotherapy that has serious limitations, such as rapid clearance, unfavorable biodistribution and severe side effects. To overcome these limitations, drug delivery systems (DDS) have been developed to encapsulate chemotherapeutics for delivery to tumor cells. However, no systematic assessment of the efficacy of chemotherapy by DDS compared to free chemotherapy (not in a DDS) has been performed for animal studies. Here, we assess the efficacy of chemotherapy in DDS on survival and tumor growth inhibition in animal studies. We searched PubMed and EMBASE (via OvidSP) to systematically identify studies evaluating chemotherapeutics encapsulated in DDS for ovarian cancer treatment in animal studies. Studies were assessed for quality and risk of bias. Study characteristics were collected and outcome data (survival/hazard ratio or tumor growth inhibition) were extracted and used for meta-analyses. Meta-analysis was performed to identify and explore which characteristics of DDS influenced treatment efficacy. A total of 44 studies were included after thorough literature screening (2,735 studies found after initial search). The risk of bias was difficult to assess, mainly because of incomplete reporting. A total of 17 studies (377 animals) and 16 studies (259 animals) could be included in the meta-analysis for survival and tumor growth inhibition, respectively. In the majority of the included studies chemotherapeutics entrapped in a DDS significantly improved efficacy over free chemotherapeutics regarding both survival and tumor growth inhibition. Subgroup analyses, however, revealed that cisplatin entrapped in a DDS did not result in additional tumor growth inhibition compared to free cisplatin, although it did result in improved survival. Micelles did not show a significant tumor growth inhibition compared to free chemotherapeutics, which indicates that micelles may not be a suitable DDS for ovarian cancer treatment. Other subgroup analyses, such as targeted versus non-targeted DDS or IV versus IP administration route, did not identify specific characteristics of DDS that affected treatment efficacy. This systematic review shows the potential, but also the limitations of chemotherapy by drug delivery systems for ovarian cancer treatment. For future animal research, we emphasize that data need to be reported with ample attention to detailed reporting. PMID:26713240

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis

PubMed Central

Bennato, Raffaele; Lombardi, Giovanni; Riccio, Elisabetta; Costantino, Giuseppe; Fries, Walter

2016-01-01

Background and Aim We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA. Methods Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis. Results Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23–2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03–1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00–2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76–2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24–1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44–1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD. Conclusions Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile. PMID:27846307

In vivo pharmacological evaluation and efficacy study of methotrexate-encapsulated polymer-coated layered double hydroxide nanoparticles for possible application in the treatment of osteosarcoma.

PubMed

Ray, Sayantan; Saha, Suman; Sa, Biswanath; Chakraborty, Jui

2017-04-01

Considering the existing drawbacks of methotrexate (MTX) with respect to its solubility and toxicity, we incorporated it in a nanoceramic matrix, Mg-Al-layered double hydroxide (LDH) to form LDH-MTX nanoparticles, and the same was in turn encapsulated in a nontoxic and biodegradable polymer, poly (D,L-lactide-co-glycolide) (PLGA), to arrest the initial burst release and dose-dumping-related toxicity, already reported by our group. Our present study was designed to evaluate the pharmacokinetics, tissue distribution, survival rate of the test animals, and antitumor efficacy of the PLGA-LDH-MTX nanoparticles and its counterpart without LDH, PLGA-MTX nanoparticles compared with bare MTX. The median lethal dose (LD 50 ) of the former was higher, compared with bare MTX, using Balb/c nude mice, indicating it to be completely safe for use. Also, a comparative pharmacokinetic and antitumour efficacy study using MTX, PLGA-MTX, and PLGA-LDH-MTX nanoparticles in osteosarcoma-induced Balb/c nude mice in vivo demonstrated superiority of PLGA-LDH-MTX as compared to PLGA-MTX and bare MTX. The results suggest that PLGA-LDH-MTX nanoparticles might exhibit potential advantages over the present-day chemotherapy over bare MTX, for the possibility of treatment of osteosarcoma.

The Quest for Comparability: Studying the Invariance of the Teachers’ Sense of Self-Efficacy (TSES) Measure across Countries

PubMed Central

Scherer, Ronny; Jansen, Malte; Nilsen, Trude; Areepattamannil, Shaljan; Marsh, Herbert W.

2016-01-01

Teachers’ self-efficacy is an important motivational construct that is positively related to a variety of outcomes for both the teachers and their students. This study addresses challenges associated with the commonly used ‘Teachers’ Sense of Self-Efficacy (TSES)’ measure across countries and provides a synergism between substantive research on teachers’ self-efficacy and the novel methodological approach of exploratory structural equation modeling (ESEM). These challenges include adequately representing the conceptual overlap between the facets of self-efficacy in a measurement model (cross-loadings) and comparing means and factor structures across countries (measurement invariance). On the basis of the OECD Teaching and Learning International Survey (TALIS) 2013 data set comprising 32 countries (N = 164,687), we investigate the effects of cross-loadings in the TSES measurement model on the results of measurement invariance testing and the estimation of relations to external constructs (i.e., working experience, job satisfaction). To further test the robustness of our results, we replicate the 32-countries analyses for three selected sub-groups of countries (i.e., Nordic, East and South-East Asian, and Anglo-Saxon country clusters). For each of the TALIS 2013 participating countries, we found that the factor structure of the self-efficacy measure is better represented by ESEM than by confirmatory factor analysis (CFA) models that do not allow for cross-loadings. For both ESEM and CFA, only metric invariance could be achieved. Nevertheless, invariance levels beyond metric invariance are better achieved with ESEM within selected country clusters. Moreover, the existence of cross-loadings did not affect the relations between the dimensions of teachers’ self-efficacy and external constructs. Overall, this study shows that a conceptual overlap between the facets of self-efficacy exists and can be well-represented by ESEM. We further argue for the cross-cultural generalizability of the corresponding measurement model. PMID:26959236

The Quest for Comparability: Studying the Invariance of the Teachers' Sense of Self-Efficacy (TSES) Measure across Countries.

PubMed

Scherer, Ronny; Jansen, Malte; Nilsen, Trude; Areepattamannil, Shaljan; Marsh, Herbert W

2016-01-01

Teachers' self-efficacy is an important motivational construct that is positively related to a variety of outcomes for both the teachers and their students. This study addresses challenges associated with the commonly used 'Teachers' Sense of Self-Efficacy (TSES)' measure across countries and provides a synergism between substantive research on teachers' self-efficacy and the novel methodological approach of exploratory structural equation modeling (ESEM). These challenges include adequately representing the conceptual overlap between the facets of self-efficacy in a measurement model (cross-loadings) and comparing means and factor structures across countries (measurement invariance). On the basis of the OECD Teaching and Learning International Survey (TALIS) 2013 data set comprising 32 countries (N = 164,687), we investigate the effects of cross-loadings in the TSES measurement model on the results of measurement invariance testing and the estimation of relations to external constructs (i.e., working experience, job satisfaction). To further test the robustness of our results, we replicate the 32-countries analyses for three selected sub-groups of countries (i.e., Nordic, East and South-East Asian, and Anglo-Saxon country clusters). For each of the TALIS 2013 participating countries, we found that the factor structure of the self-efficacy measure is better represented by ESEM than by confirmatory factor analysis (CFA) models that do not allow for cross-loadings. For both ESEM and CFA, only metric invariance could be achieved. Nevertheless, invariance levels beyond metric invariance are better achieved with ESEM within selected country clusters. Moreover, the existence of cross-loadings did not affect the relations between the dimensions of teachers' self-efficacy and external constructs. Overall, this study shows that a conceptual overlap between the facets of self-efficacy exists and can be well-represented by ESEM. We further argue for the cross-cultural generalizability of the corresponding measurement model.

Comparable Efficacy of Idelalisib Plus Rituximab and Ibrutinib in Relapsed/refractory Chronic Lymphocytic Leukemia: A Retrospective Case Matched Study of the Polish Adult Leukemia Group (PALG).

PubMed

Puła, Bartosz; Budziszewska, Bożena Katarzyna; Rybka, Justyna; Gil, Lidia; Subocz, Edyta; Długosz-Danecka, Monika; Zawirska, Daria; Waszczuk-Gajda, Anna; Iskierka-Jażdżewska, Elżbieta; Kopacz, Agnieszka; Szymczyk, Agnieszka; Czyż, Jarosław; Lech-Marańda, Ewa; Warzocha, Krzysztof; Jamroziak, Krzysztof

2018-05-01

There is limited amount of data available on the comparative efficacy of ibrutinib and idelalisib, the B-cell receptor inhibitors (BCRi) newly approved for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL) treatment. The aim of our study was to analyze and compare the outcomes of real-world r/r CLL/SLL patients treated with these two BCRi in outside clinical trials. A comparative case matched 1:2 analysis was performed on idelalisib combined with rituximab and ibrutinib efficacy in 102 patients with r/r CLL/SLL from two observational studies of the Polish Adult Leukemia Group (PALG). Both therapies produced similar overall response rates (idelalisib plus rituximab 76.4% and ibrutinib 72.1%). Median progression-free survival (PFS) and overall survival (OS) in both groups were not reached. Furthermore, no significant difference was observed between both BCRi regimens in regard to PFS (HR=0.75, 95% CI=0.30-1.86, p=0.55) and OS (HR=0.65, 95%CI=0.26-1.68, p=0.39). In summary, the results of this retrospective analysis suggest that idelalisib combined with rituximab and ibrutinib therapies have comparable activity in r/r CLL/SLL in daily clinical practice. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Testing the Efficacy of Two New Variants of Recasts with Standard Recasts in Communicative Conversational Settings: An Exploratory Longitudinal Study

ERIC Educational Resources Information Center

Wacha, Richard Charles; Liu, Yeu-Ting

2017-01-01

The purpose of this exploratory longitudinal study was to evaluate the efficacy of two new forms of recasts (i.e., elaborated and paraphrased recasts), each of which was designed to be more in accordance with contested views of input processing. The effectiveness of the two new forms of recasts was compared to that of conventional standard…

A Comparison of Two Teaching Strategies on Nursing Students' Knowledge and Self-Efficacy Regarding Their Geriatric Nursing Care

ERIC Educational Resources Information Center

Diggle-Fox, B. Suzy

2013-01-01

The purpose of this study was to examine the effectiveness of the most frequently utilized teaching strategy of lecturing followed by discussion and to compare it with lecturing followed by role playing to determine how to best prepare nursing students both in terms of knowledge and self-efficacy. The primary goal of the study was to learn how to…

A Comparison of the Influences of Different Training Approaches on Trainees' Perceptions of Self-Efficacy to Achieve Training Outcomes among Bankers in Taiwan

ERIC Educational Resources Information Center

Huang, WenRou

2010-01-01

The purpose of this study was to compare the influences of the classroom training and the structured on-the-job training (S-OJT) approaches on trainees' self-efficacy to achieve the training outcomes among bankers in Taiwan. Based on the conditions for training effectiveness identified in the literature, the study examined whether trainees with…

Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example.

PubMed

Lai, Zhihong; La Noce, Anna

2016-01-01

The global development of a biosimilar product is a methodologically complex affair, lined with potential design pitfalls and operational missteps to be avoided. Without careful attention to experimental design and meticulous execution, a development programme may fail to demonstrate equivalence, as would be anticipated for a biosimilar product, and not receive regulatory approval based on current guidance. In order to demonstrate similarity of a biosimilar product versus the originator (ie, the branded product), based on regulatory guidance, a stepwise approach is usually taken, starting with a comprehensive structural and functional characterisation of the new biological moiety. Given the sequential nature of the review process, the extent and nature of the non-clinical in vivo studies and the clinical studies to be performed depend on the level of evidence obtained in these previous step(s). A clinical efficacy trial is often required to further demonstrate biosimilarity of the two products (biosimilar vs branded) in terms of comparative safety and effectiveness. Owing to the focus on demonstrating biosimilarity and not safety and efficacy de novo, designing an adequate phase III (potentially pivotal) clinical efficacy study of a biosimilar may present some unique challenges. Using adalimumab as an example, we highlight design elements that may deserve special attention.

Clinical efficacy and safety of imepitoin in comparison with phenobarbital for the control of idiopathic epilepsy in dogs.

PubMed

Tipold, A; Keefe, T J; Löscher, W; Rundfeldt, C; de Vries, F

2015-04-01

The anticonvulsant activity and safety of imepitoin, a novel antiepileptic drug licensed in the European Union, were evaluated in a multicentre field efficacy study as well as in a safety study under laboratory conditions. Efficacy of imepitoin was compared with phenobarbital in 226 client-owned dogs in a blinded parallel group design. The administration of imepitoin twice daily in incremental doses of 10, 20 or 30 mg/kg demonstrated comparable efficacy to phenobarbital in controlling seizures in dogs. The frequency of adverse events including somnolence/sedation, polydipsia and increased appetite was significantly higher in the phenobarbital group. In phenobarbital-treated dogs, significantly increased levels of alkaline phosphatase, gamma-glutamyl-transferase and other liver enzymes occurred, while no such effect was observed in the imepitoin group. In a safety study under laboratory conditions, healthy beagle dogs were administered 0, 30, 90 or 150 mg/kg imepitoin twice daily for 26 weeks. A complete safety evaluation including histopathology was included in the study. A no-observed-adverse-event level of 90 mg/kg twice daily was determined. These results indicate that imepitoin is a potent and safe antiepileptic drug for dogs. © 2014 The Authors. Journal of Veterinary Pharmacology and Therapeutics Published by John Wiley & Sons Ltd.

The Potential Efficacy of Psychological First Aid on Self-Reported Anxiety and Mood: A Pilot Study.

PubMed

Everly, George S; Lating, Jeffrey M; Sherman, Martin F; Goncher, Ian

2016-03-01

The authors explored the efficacy of a randomized controlled trial to assess the potential benefits of psychological first aid (PFA) compared with a social acknowledgement condition in a sample of 42 participants who spoke about a stressful life event. Demographics and standardized questionnaires, including the state version of the State Trait Anxiety Inventory Scale and the Brief Profile of Mood States, assessed anxiety and mood state. Those in the PFA group evidenced significantly lower anxiety scores at 30-minute postdisclosure than at baseline and, although not significant, showed lowered distressed mood compared with baseline at 30-minute postdisclosure. Those in the social acknowledgment condition evidenced increases in anxiety and distressed mood scores, albeit not significantly, at 30 minutes post disclosure compared with their baseline scores. These results provide preliminary empirical evidence for the efficacy of PFA, and implications for intervention and additional assessment are suggested.

Antinociceptive efficacy of buprenorphine and hydromorphone in red-eared slider turtles (Trachemys scripta elegans).

PubMed

Mans, Christoph; Lahner, Lesanna L; Baker, Bridget B; Johnson, Stephen M; Sladky, Kurt K

2012-09-01

Despite the frequent clinical use of buprenorphine in reptiles, its antinociceptive efficacy is not known. In a randomized, complete cross-over study, the antinociceptive efficacy of buprenorphine (0.2 mg/kg s.c.) was compared with hydromorphone (0.5 mg/kg s.c.), and saline (0.9% s.c. equivalent volume) in 11 healthy red-eared slider turtles (Trachemys scripta elegans). Additionally, buprenorphine at 0.1 and 1 mg/kg was compared with saline in six turtles. Hindlimb withdrawal latencies were measured after exposure to a focal, thermal noxious stimulus before and between 3 hr and up to 96 hr after drug administration. Buprenorphine did not significantly increase hindlimb withdrawal latencies at any time point compared with saline. In contrast, hydromorphone administration at 0.5 mg/kg significantly increased hindlimb withdrawal latencies for up to 24 hr. These results show that hydromorphone, but not buprenorphine, provides thermal antinociception in red-eared slider turtles.

Comparative efficacy of tilmicosin versus tulathromycin as a metaphylactic antimicrobial in feedlot calves at moderate risk for respiratory disease.

PubMed

Van Donkersgoed, Joyce; Merrill, John; Hendrick, Steven

2008-01-01

The purpose of this study was to compare the efficacy and cost-effectiveness of tilmicosin (MIC) versus tulathromycin (DRAX) as a metaphylactic antimicrobial in feedlot calves at moderate risk for bovine respiratory disease (BRD). Calves that received DRAX had significantly (P < or = .05) lower initial BRD treatment rates compared with calves that received MIC. However, there were no significant differences in the BRD relapse rate, railer rate, total mortality rate, BRD mortality rate, average daily gain, and dry matter conversion between the two groups. The economic advantage of the MIC group was Can$8.29/animal. Based on these results, while DRAX was more efficacious in reducing initial treatments for BRD in feedlot calves at moderate risk for disease, MIC was more cost-effective. The lower initial BRD treatment costs in the DRAX group did not offset the higher metaphylactic cost of DRAX.

Efficacy of afoxolaner in a clinical field study in dogs naturally infested with Sarcoptes scabiei.

PubMed

Beugnet, Frédéric; de Vos, Christa; Liebenberg, Julian; Halos, Lénaïg; Larsen, Diane; Fourie, Josephus

2016-01-01

The acaricidal efficacy of afoxolaner (NexGard(®), Merial) was evaluated against Sarcoptes scabiei var. canis in a field efficacy study, when administered orally at a minimum dose of 2.5 mg/kg to dogs naturally infested with the mites. Twenty mixed-breed dogs of either sex (6 males and 14 females), aged over 6 months and weighing 4-18 kg, were studied in this randomised controlled field efficacy trial. Dogs, naturally infested with Sarcoptes scabiei var. canis confirmed by skin scrapings collected prior to allocation, were randomly divided into two equal groups. Dogs in Group 1 were not treated. Dogs in Group 2 were treated on Days 0 and 28. On Days 0 (pre-treatment), 28 (pre-treatment) and 56, five skin scrapings of similar size were taken from different sites with lesions suggestive of sarcoptic mange. The extent of lesions was also recorded on Days 0, 28 and 56, and photographs were taken. Dogs treated orally with afoxolaner had significantly (p < 0.001) lower mite counts than untreated control animals at Days 28 and 56 with no mites recovered from treated dogs at these times (100% efficacy based on mite counts). In addition, dogs treated with NexGard had significantly (p < 0.05) better lesion resolution at Day 56 than Day 0; no treated dog showed pruritus compared to 7/10 dogs in the control group, 1/9 treated dogs had crusts compared to 5/10 controls and 8/9 dogs recovered 90% of hairs on lesions compared to 0/10 control dogs. © F. Beugnet et al., published by EDP Sciences, 2016.

Efficacy of afoxolaner in a clinical field study in dogs naturally infested with Sarcoptes scabiei

PubMed Central

Beugnet, Frédéric; de Vos, Christa; Liebenberg, Julian; Halos, Lénaïg; Larsen, Diane; Fourie, Josephus

2016-01-01

The acaricidal efficacy of afoxolaner (NexGard®, Merial) was evaluated against Sarcoptes scabiei var. canis in a field efficacy study, when administered orally at a minimum dose of 2.5 mg/kg to dogs naturally infested with the mites. Twenty mixed-breed dogs of either sex (6 males and 14 females), aged over 6 months and weighing 4–18 kg, were studied in this randomised controlled field efficacy trial. Dogs, naturally infested with Sarcoptes scabiei var. canis confirmed by skin scrapings collected prior to allocation, were randomly divided into two equal groups. Dogs in Group 1 were not treated. Dogs in Group 2 were treated on Days 0 and 28. On Days 0 (pre-treatment), 28 (pre-treatment) and 56, five skin scrapings of similar size were taken from different sites with lesions suggestive of sarcoptic mange. The extent of lesions was also recorded on Days 0, 28 and 56, and photographs were taken. Dogs treated orally with afoxolaner had significantly (p < 0.001) lower mite counts than untreated control animals at Days 28 and 56 with no mites recovered from treated dogs at these times (100% efficacy based on mite counts). In addition, dogs treated with NexGard had significantly (p < 0.05) better lesion resolution at Day 56 than Day 0; no treated dog showed pruritus compared to 7/10 dogs in the control group, 1/9 treated dogs had crusts compared to 5/10 controls and 8/9 dogs recovered 90% of hairs on lesions compared to 0/10 control dogs. PMID:27317462

A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs

PubMed Central

Harman, Robert; Carlson, Kim; Gaynor, Jamie; Gustafson, Scott; Dhupa, Sarit; Clement, Keith; Hoelzler, Michael; McCarthy, Tim; Schwartz, Pamela; Adams, Cheryl

2016-01-01

Osteoarthritis (OA) is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells (MSCs) have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with OA. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM) and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived MSCs in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2 versus 55.4%, p = 0.029). The veterinary pain on manipulation score (92.8 versus 50.2%, p = 0.017) and the veterinary global score (86.9 versus 30.8%, p = 0.009) were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy. PMID:27695698

Physiotherapists use a small number of behaviour change techniques when promoting physical activity: A systematic review comparing experimental and observational studies.

PubMed

Kunstler, Breanne E; Cook, Jill L; Freene, Nicole; Finch, Caroline F; Kemp, Joanne L; O'Halloran, Paul D; Gaida, James E

2018-06-01

Physiotherapists promote physical activity as part of their practice. This study reviewed the behaviour change techniques physiotherapists use when promoting physical activity in experimental and observational studies. Systematic review of experimental and observational studies. Twelve databases were searched using terms related to physiotherapy and physical activity. We included experimental studies evaluating the efficacy of physiotherapist-led physical activity interventions delivered to adults in clinic-based private practice and outpatient settings to individuals with, or at risk of, non-communicable diseases. Observational studies reporting the techniques physiotherapists use when promoting physical activity were also included. The behaviour change techniques used in all studies were identified using the Behaviour Change Technique Taxonomy. The behaviour change techniques appearing in efficacious and inefficacious experimental interventions were compared using a narrative approach. Twelve studies (nine experimental and three observational) were retained from the initial search yield of 4141. Risk of bias ranged from low to high. Physiotherapists used seven behaviour change techniques in the observational studies, compared to 30 behaviour change techniques in the experimental studies. Social support (unspecified) was the most frequently identified behaviour change technique across both settings. Efficacious experimental interventions used more behaviour change techniques (n=29) and functioned in more ways (n=6) than did inefficacious experimental interventions (behaviour change techniques=10 and functions=1). Physiotherapists use a small number of behaviour change techniques. Less behaviour change techniques were identified in observational studies compared to experimental studies, suggesting physiotherapists use less BCTs clinically than experimentally. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Probability of assertive behaviour, interpersonal anxiety and self-efficacy of South African registered dietitians.

PubMed

Paterson, Marie; Green, J M; Basson, C J; Ross, F

2002-02-01

There is little information on the probability of assertive behaviour, interpersonal anxiety and self-efficacy in the literature regarding dietitians. The objective of this study was to establish baseline information of these attributes and the factors affecting them. Questionnaires collecting biographical information and self-assessment psychometric scales measuring levels of probability of assertiveness, interpersonal anxiety and self-efficacy were mailed to 350 subjects, who comprised a random sample of dietitians registered with the Health Professions Council of South Africa. Forty-one per cent (n=145) of the sample responded. Self-assessment inventory results were compared to test levels of probability of assertive behaviour, interpersonal anxiety and self-efficacy. The inventory results were compared with the biographical findings to establish statistical relationships between the variables. The hypotheses were formulated before data collection. Dietitians had acceptable levels of probability of assertive behaviour and interpersonal anxiety. The probability of assertive behaviour was significantly lower than the level noted in the literature and was negatively related to interpersonal anxiety and positively related to self-efficacy.

A Systematic Review of the Safety and Efficacy of Mesenchymal Stem Cells for Disc Degeneration: Insights and Future Directions for Regenerative Therapeutics

PubMed Central

Yim, Rita Lok-Hay; Lee, Juliana Tsz-Yan; Bow, Cora H.; Meij, Björn; Leung, Victor; Cheung, Kenneth M.C.; Vavken, Patrick

2014-01-01

Intervertebral disc degeneration is associated with low-back pain. Mesenchymal stem cells (MSCs) have been used to “regenerate” the disc. The aim of this study was to perform a systematic review of comparative controlled studies that have assessed the safety and efficacy of using MSCs for disc regeneration. Literature databases were extensively searched. Trial design, subject-type, MSC sources, injection method, disc assessment, outcome intervals, and complication events were assessed. Validity of each study was performed. Twenty-four animal studies were included with 20.8% of the studies reporting randomization of groups. Trials in humans fulfilling inclusion criteria were not noted. The studies represented 862 discs that were injected with MSCs and 1,603 discs as controls. All three types of MSCs (ie, bone marrow, synovial, and adipose tissues) showed successful inhibition of disc degeneration. Bone-marrow-derived MSCs demonstrated superior quality of repair compared with other non-MSC treatments. A 2.7% overall complication rate was noted, whereby complications were noted only in rabbits. Overall, evidence suggested that MSCs increased disc space height in the majority of animal models. This is the first systematic review to assess the safety and efficacy of MSCs for the treatment of disc degeneration. Short-term MSC transplantation is safe and effective; however, additional, larger, and higher-quality studies are needed to assess the long-term safety and efficacy. Inconsistencies in methodological design and outcome parameters prevent any robust conclusions. Human-based clinical trials are needed. Recommendations are further made to improve efficacy, reduce potential complications, and standardize techniques for future studies. PMID:25050446

[Therapeutic efficacy and safety of repetitive Transcranial Magnetic Stimulation in depressions of the elderly: a review].

PubMed

Jalenques, I; Legrand, G; Vaille-Perret, E; Tourtauchaux, R; Galland, F

2010-06-01

During the past 15 years, therapeutic effects of repetitive Transcranial Magnetic Stimulation (rTMS) have been studied in psychiatric diseases, particularly in the treatment of depressive disorders. There are more and more data suggesting its efficacy in the treatment of depression in older patients. Thus, the authors found it useful to conduct an up-to-date review of studies that examined the efficacy and safety of rTMS to treat depressive disorders in the aged. After an exhaustive consultation of databases (Medline/PubMed and the Avery-George-Holtzheimer Database of rTMS Depression Studies), supplemented by a manual research, the authors retained studies evaluating the therapeutic efficacy of rTMS on depressive disorders in the aged. Fifteen studies were retained. Four open studies using high frequency rTMS, applied to the left dorsolateral prefrontal cortex (DLPFC), demonstrated a decrease in the mean Hamilton Depression Rating Scale (HDRS) scores; however, only a quarter of the aged patients studied experienced a significant remission of depression. Five parallel arm double-blind versus placebo studies concluded in contradicting results: two studies confirmed a significantly greater efficacy of rTMS compared to placebo, whereas three studies did not; but the sham procedure (positioning coil at 90 degrees from the scalp) was disputable in most studies. One study concluded in therapeutic efficacy by inhibiting the right DLPFC. Three controlled parallel arm studies compared rTMS and electroconvulsive-therapy (ECT); one study concluded in greater efficacy of ECT at end of treatment, but the number of ECT treatments depended on the patients' response, whereas a 15-day course of rTMS was systematically administered; additionally HDRS scores were similar in two groups of patients (rTMS and ECT) at 6 months. Lastly, three studies focused on aged patients with cerebrovascular disease. They showed the efficacy of rTMS, although older age and smaller frontal gray mater volumes were associated with a poorer response to rTMS. Thus, although some studies concluded contradicting results, literature data globally sustain an efficacy of rTMS for depression in the elderly. Several parameters might be associated with greater antidepressant efficacy (higher intensity pulses of rTMS of the left DLPFC; higher number of stimulations or higher number of rTMS sessions). Poorer responsiveness to rTMS may be related to several patients' factors including older age and smaller frontal gray matter volumes; lesions of the white matter pathways connecting the left DLPFC and the left anterior cingulate cortex might explain a poor response to rTMS. Literature data globally confirm that rTMS is safe and does not produce cognitive deficits, even among highly vulnerable patients with clinical evidence of cerebrovascular disease. Many questions remain concerning the optimal stimulation parameters, administration protocol, and privileged indications. Thus, the next rTMS studies should be carefully designed to clarify these questions. Copyright (c) 2009 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

Social and emotional self-efficacy at work.

PubMed

Loeb, Carina; Stempel, Christiane; Isaksson, Kerstin

2016-04-01

Research has shown that self-efficacy is often one of the most important personal resources in the work context. However, because this research has focused on cognitive and task-oriented self-efficacy, little is known about social and emotional dimensions of self-efficacy at work. The main aim of the present study was to investigate social and emotional self-efficacy dimensions at work and to compare them to a cognitive and task-oriented dimension. Scales to measure social and emotional self-efficacy at work were developed and validated and found to be well differentiated from the cognitive task-oriented occupational self-efficacy scale. Confirmatory factor analyses of data from 226 Swedish and 591 German employees resulted in four separate but correlated self-efficacy dimensions: (1) occupational; (2) social; (3) self-oriented emotional; and (4) other-oriented emotional. Social self-efficacy explained additional variance in team climate and emotional self-efficacy in emotional irritation and emotional exhaustion, over and above effects of occupational self-efficacy. Men reported higher occupational self-efficacy, whereas social and emotional self-efficacy revealed no clear gender differences. The scales have strong psychometric properties in both Swedish and German language versions. The positive association between social self-efficacy and team climate, and the negative relationships between self-oriented emotional self-efficacy and emotional irritation and emotional exhaustion may provide promising tools for practical applications in work settings such as team-building, staff development, recruitment or other training programs aiming for work place health promotion. The next step will be to study how social and emotional self-efficacy relate to leadership, well-being and health over time. © 2016 Scandinavian Psychological Associations and John Wiley & Sons Ltd.

The role of self-efficacy in explaining gender differences in physical activity among adolescents: a multilevel analysis.

PubMed

Spence, John C; Blanchard, Chris M; Clark, Marianne; Plotnikoff, Ronald C; Storey, Kate E; McCargar, Linda

2010-03-01

The purposes of this study were to determine if a) gender moderated the relationship between self-efficacy and physical activity (PA) among youth in Alberta, Canada, and, alternatively b) if self-efficacy mediated the relationship between gender and PA. A novel web-based tool was used to survey a regionally diverse sample of 4779 students (boys = 2222, girls = 2557) from 117 schools in grades 7 to 10 (mean age = 13.64 yrs.). Among other variables, students were asked about their PA and self-efficacy for participating in PA. Based upon a series of multilevel analyses, self-efficacy was found to be a significantly stronger correlate of PA for girls. But, boys had significantly higher self-efficacy compared with girls, which resulted in significantly more PA. Findings suggest self-efficacy is an important correlate of PA among adolescent girls but that boys are more physically active because they have more self-efficacy for PA.

Comparative study of antibacterial and antifungal effects of rigid gas permeable contact lens disinfecting solutions.

PubMed

Kuzman, Tomislav; Kutija, Marija Barisić; Kordić, Rajko; Popović-Sui, Smiljka; Jandroković, Sonja; Skegro, Ivan; Pokupec, Rajko

2013-04-01

The aim of this study was to compare antimicrobial efficacy of rigid contact lens disinfecting solutions. We tested five commercially available solutions: Unique pH (Alcon Laboratories), Boston Advance (Polymer Technology Corp.), Nitilens Conditioner GP (Avizor), Total Care (AMO), Boston Simplus (Bausch&Lomb). Their efficacy to disinfect saline solution experimentally contaminated with American Type Culture Collection (ATCC): Staphylococcus aureus (ATCC 25923), Escherichia coli (ATCC 25922), Pseudomonas aeruginosa (ATCC 27853), Candida albicans (ATCC 90028) and Staphylococcus epidermidis (isolated from our laboratory) was tested. All tested solutions reduced concentrations of bacteria and fungi below 1000 CFU/mL (Colony forming unit; reduction by 3 log and 1 log, respectively) after the 8 hours period. Overall, all contact lens care solutions showed good disinfecting activity against tested bacteria and fungi, with more variation in their antifungal than in antibacterial efficacy. Results of our study might be valuable when selecting appropriate solutions for non-compliant contact lens wearers.

[Treatment of clavicular fractures using intramedullary nailing or K-wire versus plating fixation: a meta-analysis].

PubMed

Zhang, Ke-xue; Zhao, Jing-xin; Zhao, Zhe; Ng, Li-cheng; Su, Xiu-yun; Long, An-hua; Mao, Zhi; Zhang, Jin-hui; Zhang, Li-hai; Tang, Pei-fu

2015-05-01

TFo compare the efficacy and complications rate of intramedullary (IM) nailing or K-wire versus plating fixation for clavicular fractures. Pubmed, Embase, Cochrane Library databases, CNKI, VIP and Wangfang databases were searched to find all randomized or quasi-randomized controlled trials of clavicle fractures using plating versus IM nailing or K-wire. The methodologic quality of the studies was assessed. After independent study selection by 2 authors ,data were collected and extracted independently. Outcomes of postoperative shoulder functional measurement, the efficacy and information of the operation and complications rate were meta-analyzed using RevMan 5 software. Nine hundreds and seventy-six patients in 10 randomized controlled trials (RCTs) and 3 quasi-RCTs were involved in the meta-analysis,of which 5 studies compared the K-wire and the plating fixations and 8 studies compared the IM nailing and the plating fixations. The overall odds ratio(OR) (with 95% CI) of the operation efficacy for K-wire versus the plating was 3.79 (1.93, 7.46). The overall weighted mean difference (with 95% CI) of Constant Shoulder score for plating versus IM fixation was -1.39 (-3.43, 0.65) in 6 studies. The overall OR of the plating versus IM nailing was 9.34(2.70, 32.32) for the overall major complications in 5 studies and 5.04 (1.52,16.77) for the revision rate in 5 studies. The current limited evidences suggested that the IM fixation could reduce the incidences of the overall major complications and the revision surgery, while the post-operative efficacy of the plating was superior to the K-wire. More high quality RCTs are still needed in the future.

Polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence in women: a systematic review of the literature.

PubMed

Kasi, Anushuya Devi; Pergialiotis, Vasilios; Perrea, Despina N; Khunda, Azar; Doumouchtsis, Stergios K

2016-03-01

Polyacrylamide hydrogel (PAHG, Bulkamid®) is one of several injectable agents currently used for the treatment of women with urinary stress incontinence. Although bulking agents appear to have lower efficacy rates compared to other surgical treatments, current evidence based on large prospective or comparative studies as well as systematic reviews is limited. The purpose of this study was to conduct a systematic review on the efficacy of PAHG in the treatment of female patients with stress urinary incontinence with regard to reproducibility, feasibility, safety and clinical outcome. We searched MEDLINE (1966-2015), Scopus (2004-2015), POPLINE (1974-2015) and ClinicalTrials.gov (2008-2015) along with reference lists of electronically retrieved studies. Observational studies, prospective, retrospective and randomized controlled studies were included. Two reviewers independently selected studies, assessed the risk of bias and tabulated data to structured forms. We included 8 studies, which enrolled a total of 767 patients who received treatment with PAHG. We found that 186 of 767 women (24.3 %, range 12-35 %) required reinjection in order to achieve adequate efficacy. The most frequent adverse effects were pain at the site of injection (4-14 %) and urinary tract infections (3-7 %). Both the number of incontinence episodes/24 h and the number of ml/24 h were significantly reduced 1 year following treatment and the quality of life of patients was significantly improved. PAHG is a safe intervention for treating women with stress urinary incontinence, but repeat injections are often required. Further research is mandated in the field in order to compare its efficacy to other bulking agents.

Experimental evaluation of efficacy and healing response of everolimus-eluting stents in the familial hypercholesterolemic swine model: a comparative study of bioabsorbable versus durable polymer stent platforms.

PubMed

Tellez, Armando; Seifert, Paul S; Donskoy, Elina; Sushkova, Natalia; Pennington, Douglas E; Milewski, Krzysztof; Krueger, Christian G; Kaluza, Greg L; Eppihimer, Michael J; Huibregtse, Barbara A; Dawkins, Keith D; Granada, Juan F

2014-05-01

The utility of animal models for the prediction of drug-eluting stent (DES) efficacy in human clinical trials is still unclear. The familial hypercholesterolemic swine (FHS) model has been shown to induce a human-like neointimal response to bare metal stent (BMS) implantation. However, its utility to discriminate efficacy signals following DES implantation is unknown. In this study, we aimed to test the efficacy and healing response of several everolimus-eluting stent (EES) platforms in the coronary territory of the FHS. A total of 19 EES platforms (SYNERGY=6, SYNERGY½-dose=7, and PROMUS Element=6) and an identical BMS control (Element=6) were implanted into the coronary arteries of nine FHS. All implants were performed under intravascular ultrasound guidance using a 1.2 : 1 overstretch ratio. At 30 days, the vascular response to the implant was evaluated by quantitative coronary angiography, optical coherence tomography, and histology. At 28 days, all EES platforms showed a significant decrease in angiographic late lumen loss (between 27 and 37%) compared with the BMS control group. This finding was confirmed both by optical coherence tomography (mean neointimal thickness=28-42% reduction) and by histology (mean neointimal thickness=44-55% reduction). All EES platforms showed similar degrees of neointimal inhibition. The presence of moderate to severe para-strut inflammation was observed in 83% of the stent sections in the BMS group compared with 28.6% in the SYNERGY½-dose group and 0% in the SYNERGY and PROMUS groups (P=0.0002). There was a 68-95% reduction in MMP9 expression in the media in all EES platforms compared with the BMS controls. The presence of mild to moderate para-strut fibrin deposits ranged from 66.7 to 83.4% in all EES platforms compared with 16.7% in the EBMS group. The FHS coronary injury model showed the efficacy of several EES platforms compared with an identical BMS control. Everolimus eluted from different polymeric platforms showed lower levels of inflammation and slightly higher fibrin deposits compared with BMS controls.

Evaluation of a mobile social networking application for improving diabetes Type 2 knowledge: an intervention study using WhatsApp.

PubMed

Turki, Alanzi; Sulaiman, Bah; Sara, Alzahrani; Sirah, Alshammari; Fatima, Almunsef

2018-06-26

The aim of this study is to evaluate the WhatsApp social networking application for improving knowledge, self-efficacy and awareness about diabetes management. The study was conducted with intervention and control groups at Teaching Hospital in Al-Khobar, Saudi Arabia. The intervention group received weekly educational messages using WhatsApp, while the control group received regular care. Statistically, compared with the control group, the diabetes knowledge and self-efficacy of the intervention group increased significantly after the intervention with the WhatsApp application. The WhatsApp application can be effectively used for enhancing diabetes knowledge, self-efficacy and awareness among the Saudi population.

Comparative Efficacy of Tongxinluo Capsule and Beta-Blockers in Treating Angina Pectoris: Meta-Analysis of Randomized Controlled Trials.

PubMed

Jia, Yongliang; Leung, Siu-wai

2015-11-01

There have been no systematic reviews, let alone meta-analyses, of randomized controlled trials (RCTs) comparing tongxinluo capsule (TXL) and beta-blockers in treating angina pectoris. This study aimed to evaluate the efficacy of TXL and beta-blockers in treating angina pectoris by a meta-analysis of eligible RCTs. The RCTs comparing TXL with beta-blockers (including metoprolol) in treating angina pectoris were searched and retrieved from databases including PubMed, Chinese National Knowledge Infrastructure, and WanFang Data. Eligible RCTs were selected according to prespecified criteria. Meta-analysis was performed on the odds ratios (OR) of symptomatic and electrocardiographic (ECG) improvements after treatment. Subgroup analysis, sensitivity analysis, meta-regression, and publication biases analysis were conducted to evaluate the robustness of the results. Seventy-three RCTs published between 2000 and 2014 with 7424 participants were eligible. Overall ORs comparing TXL with beta-blockers were 3.40 (95% confidence interval [CI], 2.97-3.89; p<0.0001) for symptomatic improvement and 2.63 (95% CI, 2.29-3.02; p<0.0001) for ECG improvement. Subgroup analysis and sensitivity analysis found no statistically significant dependence of overall ORs on specific study characteristics except efficacy criteria. Meta-regression found no significant except sample sizes for data on symptomatic improvement. Publication biases were statistically significant. TXL seems to be more effective than beta-blockers in treating angina pectoris, on the basis of the eligible RCTs. Further RCTs are warranted to reduce publication bias and verify efficacy.

Perceived somatic and affective barriers for self-efficacy and physical activity.

PubMed

Warner, Lisa M; Wolff, Julia K; Spuling, Svenja M; Wurm, Susanne

2017-05-01

According to Bandura's social-cognitive theory, perceptions of somatic and affective barriers are sources of self-efficacy. This longitudinal study compares general indicators of health barriers with measures of perceived somatic and affective barriers to predict self-efficacy and accelerometer-assessed physical activity in a subsample of n = 153 (selected at random from N = 310) community-dwelling German older adults. Perceived somatic and affective barriers longitudinally predicted physical activity mediated by self-efficacy, whereas general health barriers did not. Perceived health barriers to physical activity might be more important than more objective health barriers for older adults' physical activity levels.

A comparative study to evaluate efficacy, safety and cost-effectiveness between Whitfield's ointment + oral fluconazole versus topical 1% butenafine in tinea infections of skin.

PubMed

Thaker, Saket J; Mehta, Dimple S; Shah, Hiral A; Dave, Jayendra N; Kikani, Kunjan M

2013-01-01

The aim of this study is to compare the efficacy, safety and cost-effectiveness of topical Whitfield's ointment plus oral fluconazole with topical 1% butenafine in tinea infections of the skin. Patients were randomly allocated to the two treatment groups and advised to apply either agent topically twice-a-day for 4 weeks on the lesions and fluconazole (150 mg) was administered once a week for 4 weeks in the study group applying Whitfield's ointment. Patients were followed-up at an interval of 10 days for clinical score and global evaluation response was assessed at baseline and during each follow-up. Out of 120 patients enrolled in the study 103 completed the study. Patients treated with Whitfield's ointment and oral fluconazole reduced mean sign and symptom score from 8.81 ± 0.82 to 0.18 ± 0.59 while butenafine treated patients reduced it from 8.88 ± 0.53 to 0.31 ± 0.67 at the end of the treatment. Nearly, 98% patients were completely cleared of the lesion on the 3(rd) follow-up with both treatments. Whitfield's ointment with oral fluconazole is as efficacious, safe and cost-effective as compared with 1% butenafine in tinea infections of the skin.

Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

PubMed

Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

2017-11-01

Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

Ziprasidone and amisulpride effectively treat negative symptoms of schizophrenia: results of a 12-week, double-blind study.

PubMed

Olié, Jean-Pierre; Spina, Edoardo; Murray, Stephen; Yang, Ruoyong

2006-05-01

We compared the efficacy of ziprasidone and amisulpride in the treatment of negative symptoms and overall psychopathology in subjects who had chronic schizophrenia with predominantly negative symptoms. This multicentre, 12-week, double-blind study randomly assigned subjects with predominantly negative-symptom schizophrenia [i.e. Positive and Negative Syndrome Scale (PANSS) Negative Subscale score >or=6 points greater than Positive Subscale score] to ziprasidone (40-80 mg b.i.d.; n=60) or amisulpride (50-100 mg b.i.d.; n=63). The primary efficacy variable was the change from baseline in PANSS Negative Subscale score. Secondary efficacy variables included change in scores for PANSS Total, Global Assessment of Functioning, Brief Psychiatric Rating Scale derived from PANSS Total and Core, Clinical Global Impression (CGI)-Severity and CGI-Improvement. For the change in PANSS Negative Subscale score, a ratio to assess the equivalence of the treatment groups was calculated from the least squares mean changes from baseline, with equivalence claimed if the lower limit of the 95% confidence interval of the ratio exceeded 0.60. Mean daily dose, adjusted for differential numbers of subjects and differential days between visits, was 118.0 mg for ziprasidone and 144.7 mg for amisulpride. Mean PANSS Negative Subscale scores improved over the 12-week treatment period for intent-to-treat subjects, evaluable subjects (subjects with >or=4 weeks of double-blind treatment and no protocol deviations) and completers in both treatment groups. Ziprasidone demonstrated efficacy comparable to amisulpride in improving negative symptoms and global psychopathology. The groups demonstrated comparable improvements in secondary efficacy variables. Both agents were generally well tolerated, with comparably low incidences of movement disorders. In subjects with negative symptom-prominent schizophrenia, ziprasidone in mean daily doses of 118 mg was equivalent to amisulpride in mean daily doses of 148 mg in ameliorating negative symptoms and comparable in improving overall psychopathology and global illness severity.

Efficacy and safety of curcumin and its combination with boswellic acid in osteoarthritis: a comparative, randomized, double-blind, placebo-controlled study.

PubMed

Haroyan, Armine; Mukuchyan, Vahan; Mkrtchyan, Nana; Minasyan, Naira; Gasparyan, Srbuhi; Sargsyan, Aida; Narimanyan, Mikael; Hovhannisyan, Areg

2018-01-09

The aim of this clinical trial was to assess the efficacy and safety of curcuminoid complex extract from turmeric rhizome with turmeric volatile oil (CuraMed®) and its combination with boswellic acid extract from Indian frankincense root (Curamin®) vs placebo for the treatment of 40- to 70-year-old patients with osteoarthritis (OA). The effects of CuraMed® 500-mg capsules (333 mg curcuminoids) and Curamin® 500-mg capsules (350 mg curcuminoids and 150 mg boswellic acid) taken orally three times a day for 12 weeks in 201 patients was investigated in a three-arm, parallel-group, randomized, double-blinded, placebo-controlled trial. Primary outcome efficacy measures included OA physical function performance-based tests, the WOMAC recommended index of joint pain, morning stiffness, limitations of physical function, and the patients' global assessment of disease severity. Favorable effects of both preparations compared to placebo were observed after only 3 months of continuous treatment. A significant effect of Curamin® compared to placebo was observed both in physical performance tests and the WOMAC joint pain index, while superior efficacy of CuraMed vs placebo was observed only in physical performance tests. The effect size compared to placebo was comparable for both treatment groups but was superior in the Curamin® group. The treatments were well tolerated. Twelve-week use of curcumin complex or its combination with boswellic acid reduces pain-related symptoms in patients with OA. Curcumin in combination with boswellic acid is more effective. Combining Curcuma longa and Boswellia serrata extracts in Curamin® increases the efficacy of OA treatment presumably due to synergistic effects of curcumin and boswellic acid. This trial is registered at the database www.clinicaltrials.gov . https://clinicaltrials.gov/ct2/show/NCT02390349?term=EuroPharma&rank=1 . Study registration number: NCT02390349 .

Sex Differences in Smoking Cessation Pharmacotherapy Comparative Efficacy: A Network Meta-analysis

PubMed Central

Weinberger, Andrea H.; Zhang, Ju; Emme, Erin; Mazure, Carolyn M.; McKee, Sherry A.

2017-01-01

Abstract Introduction: Converging clinical and biological evidence suggest sex is an important factor when selecting a pharmacological intervention for smoking cessation. The current investigation used network meta-analyses to estimate sex differences in the comparative efficacy of transdermal nicotine (TN), varenicline, and sustained release (SR) bupropion for smoking cessation. Methods: Systematically searched previously published reviews and databases (Medline, PsycINFO, Embase) of randomized, double-blind, placebo-controlled trials of bupropion-SR, TN, and varenicline for cigarette smoking cessation in primary care/general community samples were included. Results: Thirty-two studies met all criteria and 28 (88%) were included in the final analyses, representing 14 389 smokers (51% female). Results of the full sample (women and men combined) mirrored those from a Cochrane Tobacco Addiction Group network meta-analysis of smoking cessation pharmacotherapy, showing VAR>TN=BUP. All medications improved quit rates over placebo for both women and men. Relative to placebo, varenicline efficacy was similar for women and men. Significant sex differences were evident when comparing varenicline versus TN and varenicline versus bupropion. For women, varenicline was more efficacious than TN (RR = 1.41; 95% CI = 1.12,1.76) and bupropion (RR = 1.38; 95% CI = 1.08,1.77). For men, outcomes for those treated with TN and bupropion were similar to those treated with varenicline. There were no differences in efficacy when comparing bupropion versus TN. Conclusions: The advantage of varenicline over bupropion SR and TN is greater for women than men. Clinicians should strongly consider varenicline as the first option treatment for women. Among men, the advantage of varenicline over TN or bupropion is less clear. Implications: This study provides information for the sex-informed treatment of nicotine addiction among cigarette smokers. Relative to placebo, women and men achieved similar outcomes when treated with varenicline; however the advantages of varenicline over transdermal patch and bupropion were greater for women compared to men. PMID:27613893

Single-Dose Oritavancin Treatment of Acute Bacterial Skin and Skin Structure Infections: SOLO Trial Efficacy by Eron Severity and Management Setting.

PubMed

Deck, Daniel H; Jordan, Jennifer M; Holland, Thomas L; Fan, Weihong; Wikler, Matthew A; Sulham, Katherine A; Ralph Corey, G

2016-09-01

Introduction of new antibiotics enabling single-dose administration, such as oritavancin may significantly impact site of care decisions for patients with acute bacterial skin and skin structure infections (ABSSSI). This analysis compared the efficacy of single-dose oritavancin with multiple-dose vancomycin in patients categorized according to disease severity via modified Eron classification and management setting. SOLO I and II were phase 3 studies evaluating single-dose oritavancin versus 7-10 days of vancomycin for treatment of ABSSSI. Patient characteristics were collected at baseline and retrospectively analyzed. Study protocols were amended, allowing outpatient management at the discretion of investigators. In this post hoc analysis, patients were categorized according to a modified Eron severity classification and management setting (outpatient vs. inpatient) and the efficacy compared. Overall, 1910 patients in the SOLO trials were categorized into Class I (520, 26.5%), II (790, 40.3%), and III (600, 30.6%). Of the 767 patients (40%) in the SOLO trials who were managed entirely in the outpatient setting 40.3% were categorized as Class II and 30.6% were Class III. Clinical efficacy was similar between oritavancin and vancomycin treatment groups, regardless of severity classification and across inpatient and outpatient settings. Class III patients had lower response rates (oritavancin 73.3%, vancomycin 76.6%) at early clinical evaluation when compared to patients in Class I (82.6%) or II (86.1%); however, clinical cure rates at the post-therapy evaluation were similar for Class III patients (oritavancin 79.8%, vancomycin 79.9%) when compared to Class I and II patients (79.1-85.7%). Single-dose oritavancin therapy results in efficacy comparable to multiple-dose vancomycin in patients categorized according to modified Eron disease severity classification regardless of whether management occurred in the inpatient or outpatient setting. The Medicines Company, Parsippany, NJ, USA. ClinicalTrials.gov identifiers, NCT01252719 (SOLO I) and NCT01252732 (SOLO II).

Comparison of Efficacy Between Endoscopic Cyclophotocoagulation and Alternative Surgeries in Refractory Glaucoma

PubMed Central

Yang, Yangfan; Zhong, Jing; Dun, Zhongjun; Liu, Xiao-an; Yu, Minbin

2015-01-01

Abstract Refractory glaucoma refers to uncontrolled intraocular pressure (IOP) despite anti-glaucoma medication and surgical treatment, which remains a challenge to be treated. The objective of this study is to evaluate and statistically compare the clinical efficacy between endoscopic cyclophotocoagulation (ECP) and alternative surgical techniques in the treatment of refractory glaucoma in this article, as a meta-analysis. Data sources are China Biomedical Database (Sinomed, online version), China National Knowledge Infrastructure (CNKI), Cqvip, Wanfang database, and PubMed. The randomized controlled trial (RCT) and case–control study literatures evaluating the clinical efficacy between ECP and other surgical techniques were searched electronically from public databases. The methodology quality of the retrieved articles was evaluated according to the RCT or case–control study criteria. The success rate of treatment, intraocular pressure (IOP) and visual acuity were statistically compared. RevMan 5.3 software was used for the meta-analysis. In total, 6 relevant control studies were selected in this study with a total sampling of 429 cases (429 eyes), including 204 eyes in the ECP group and 225 in the non-ECP group. Meta-analysis demonstrated that the clinical efficacy did not significantly differ between 2 groups (P > 0.05). Postoperative IOP was dramatically reduced in both groups. However, it was difficult to evaluate the combined influence of ECP and non-ECP therapies upon IOP reduction. In conclusion, ECP and non-ECP treatment yielded almost equivalent clinical efficacy in treating refractory glaucoma. The IOP-lowering degree, safety, and incidence of complications remain to be further elucidated by RCTs with a larger sample size. PMID:26426659

Strengths, weaknesses and future challenges of biosimilars' development. An opinion on how to improve the knowledge and use of biosimilars in clinical practice.

PubMed

Scavone, Cristina; Rafaniello, Concetta; Berrino, Liberato; Rossi, Francesco; Capuano, Annalisa

2017-12-01

Biosimilars started receiving the marketing authorization by European Medicine Agency since 2006. The development of biosimilars follows a well-defined step-wise approach, the so-called comparability exercise, which aims to compare non-clinical (mainly quality features and biological activity) and clinical (efficacy and safety profiles) features of new biosimilars with their respective reference products. Despite the undeniable advantages of such procedure, some concerns (such as the absence of switching studies or the evaluation of efficacy and safety in all therapeutic indications) still exist about its. In particular, the European regulatory framework on biosimilars approval does not include the conduction of switching studies demonstrating the interchangeability to be carried out before marketing authorization. This is one of the main aspects that negatively affects healthcare professionals' clinical decisions on switch. In order to achieve a better knowledge on safety and efficacy of biosimilar drugs, real world data should be collected and post-marketing efficacy and safety clinical studies (including those evaluating specific endpoints, therapeutic regimens and patients population), should be planned. also the conduction of well-designed switching studies is highly advisable, especially in the case of biosimilar drugs used in oncology settings. Lastly, considering the critical role of antidrug antibodies on efficacy/safety profile of biologic drugs, studies based on therapeutic drug monitoring would be useful in order to achieve treatment optimization. Implementing the above strategies could be helpful to fill the gap in knowledge observed in the present European biosimilar regulatory framework. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effects of a Web-Based Antenatal Care System on Maternal Stress and Self-Efficacy During Pregnancy: A Study in Taiwan.

PubMed

Tsai, Yi-Jing; Hsu, Yu-Yun; Hou, Ting-Wei; Chang, Chiung-Hsin

2018-03-01

Women may experience significant stress during pregnancy, and antenatal care and education provide a means to address this. E-health, the use of computer and information technology for health care, has been incorporated into antenatal care and education, but e-health has not been evaluated for its usefulness in addressing stress. The objective of this study was to investigate the effectiveness of a web-based antenatal care and education system on pregnancy-related stress, general self-efficacy, and satisfaction with antenatal care. A quasi-experimental design enrolled pregnant women at 16 to 24 weeks' gestation with a low-risk pregnancy. Women in the control group (n = 67) received routine antenatal care; women in the experimental group (n = 68) also received a web-based antenatal care and education program in the second trimester. Pregnancy stress and general self-efficacy were assessed at study entry and again at 36 to 38 weeks' gestation; satisfaction with care was assessed at the study endpoint. When the pretest scores were controlled, the women in the experimental group reported significantly lower pregnancy-related stress (F  =  12.9, P < .001) and significantly higher self-efficacy (F = 17.61, P < .001) than did the women in the control group. Women in the experimental group reported lower pregnancy-related stress (t = 5.09, P < .001) and a higher general self-efficacy (t = -3.17, P = .001) at posttest compared to pretest. However, the women in the control group reported a lower general self-efficacy at posttest compared to pretest (t = 2.86, P = .006). Women in the experimental group reported significantly higher satisfaction levels with antenatal care than those in the control group. A web-based antenatal care and education system can improve pregnancy-related stress and general self-efficacy among pregnant women. Integrating health care with web-based or internet-based interventions may improve the quality of antenatal care. © 2018 by the American College of Nurse-Midwives.

Hydromorphone efficacy and treatment protocol impact on tolerance and mu-opioid receptor regulation.

PubMed

Kumar, Priyank; Sunkaraneni, Soujanya; Sirohi, Sunil; Dighe, Shveta V; Walker, Ellen A; Yoburn, Byron C

2008-11-12

This study examined the antinociceptive (analgesic) efficacy of hydromorphone and hydromorphone-induced tolerance and regulation of mu-opioid receptor density. Initially s.c. hydromorphone's time of peak analgesic (tail-flick) effect (45 min) and ED50 using standard and cumulative dosing protocols (0.22 mg/kg, 0.37 mg/kg, respectively) were determined. The apparent analgesic efficacy (tau) of hydromorphone was then estimated using the operational model of agonism and the irreversible mu-opioid receptor antagonist clocinnamox. Mice were injected with clocinnamox (0.32-25.6 mg/kg, i.p.) and 24 h later, the analgesic potency of hydromorphone was determined. The tau value for hydromorphone was 35, which suggested that hydromorphone is a lower analgesic efficacy opioid agonist. To examine hydromorphone-induced tolerance, mice were continuously infused s.c. with hydromorphone (2.1-31.5 mg/kg/day) for 7 days and then morphine cumulative dose response studies were performed. Other groups of mice were injected with hydromorphone (2.2-22 mg/kg/day) once, or intermittently every 24 h for 7 days. Twenty-four hours after the last injection, mice were tested using morphine cumulative dosing studies. There was more tolerance with infusion treatments compared to intermittent treatment. When compared to higher analgesic efficacy opioids, hydromorphone infusions induced substantially more tolerance. Finally, the effect of chronic infusion (31.5 mg/kg/day) and 7 day intermittent (22 mg/kg/day) hydromorphone treatment on spinal cord mu-opioid receptor density was determined. Hydromorphone did not produce any change in mu-opioid receptor density following either treatment. These results support suggestions that analgesic efficacy is correlated with tolerance magnitude and regulation of mu-opioid receptors when opioid agonists are continuously administered. Taken together, these studies indicate that analgesic efficacy and treatment protocol are important in determining tolerance and regulation of mu-opioid receptors.

Comparison of the medical students' perceived self-efficacy and the evaluation of the observers and patients.

PubMed

Ammentorp, Jette; Thomsen, Janus Laust; Jarbøl, Dorte Ejg; Holst, René; Øvrehus, Anne Lindebo Holm; Kofoed, Poul-Erik

2013-04-08

The accuracy of self-assessment has been questioned in studies comparing physicians' self-assessments to observed assessments; however, none of these studies used self-efficacy as a method for self-assessment. The aim of the study was to investigate how medical students' perceived self-efficacy of specific communication skills corresponds to the evaluation of simulated patients and observers. All of the medical students who signed up for an Objective Structured Clinical Examination (OSCE) were included. As a part of the OSCE, the student performance in the "parent-physician interaction" was evaluated by a simulated patient and an observer at one of the stations. After the examination the students were asked to assess their self-efficacy according to the same specific communication skills. The Calgary Cambridge Observation Guide formed the basis for the outcome measures used in the questionnaires. A total of 12 items was rated on a Likert scale from 1-5 (strongly disagree to strongly agree). We used extended Rasch models for comparisons between the groups of responses of the questionnaires. Comparisons of groups were conducted on dichotomized responses. Eighty-four students participated in the examination, 87% (73/84) of whom responded to the questionnaire. The response rate for the simulated patients and the observers was 100%. Significantly more items were scored in the highest categories (4 and 5) by the observers and simulated patients compared to the students (observers versus students: -0.23; SE:0.112; p=0.002 and patients versus students:0.177; SE:0.109; p=0.037). When analysing the items individually, a statistically significant difference only existed for two items. This study showed that students scored their communication skills lower compared to observers or simulated patients. The differences were driven by only 2 of 12 items. The results in this study indicate that self-efficacy based on the Calgary Cambridge Observation guide seems to be a reliable tool.

Improving the self-efficacy of teachers in schools: results of health promotion program.

PubMed

Farokhzadian, Jamileh; Sabzi, Amirreza; Mangolian Shahrbabaki, Parvin

2018-06-12

Background In order to effectively facilitate behavior change, it is essential to conduct health promotion programs on self-efficacy. Given the importance of the role of teachers in fostering the next generation, it appears that the promotion of self-efficacy in them can greatly contribute to the health of the community. The present study aimed to evaluate the impact of a health promotion training workshop on self-efficacy for health practices and also, on general self-efficacy of teachers in schools. Methods This study was a quasi-experimental study, in which 120 teachers were selected by random sampling and randomly divided into two equal intervention and control groups (60 in each group). A health promotion training workshop was conducted for the intervention group. Data were collected by a three-section questionnaire (demographic, self-rated ability for health practices scale and general self-efficacy) before and 1 month after the training intervention. Results The self-efficacy scores for health practices and general self-efficacy were not significantly different between the intervention and control groups before the intervention (p > 0.05). However, participants in the intervention group reported higher scores on both the self-efficacy for health practices (t = 4.05, p = 0.001) and general self-efficacy (t = 2.92, p = 0.004) compared to those in the control group one month after the intervention. Conclusion The health promotion training program had improving effects on the self-efficacy for health practices and general self-efficacy. This program was potentially a valid community health nursing intervention that can be presented and evaluated in various community settings.

Effects of a Brief Interest Inventory Intervention on Career Decision Self-Efficacy

ERIC Educational Resources Information Center

Isik, Erkan

2014-01-01

The purpose of this study was to examine the effects of a brief interest inventory intervention on career decision self-efficacy in an undergraduate sample. A pretest-posttest equivalent group design compared students who completed an interest inventory and participated in two sessions of its interpretation, students who only completed an interest…

Impact of Mentoring on K-12 Beginning Teachers' Efficacy and Commitment: A Comparative Phenomenological Study

ERIC Educational Resources Information Center

Mozdzanowski, Sandra Kay

2016-01-01

Despite a growing body of literature on the needs of beginning teachers, little is known about the impact of mentoring on K-12 beginning teachers' efficacy and commitment to teaching, and why beginning teachers in special education received less mentoring than their counterparts in general education. This qualitative phenomenological study…

Discovering the Impact of Community Policing: The Broken Windows Thesis, Collective Efficacy, and Citizens' Judgment

ERIC Educational Resources Information Center

Xu, Yili; Fiedler, Mora L.; Flaming, Karl H.

2005-01-01

The main purpose of the present study is to demonstrate the structure, mechanisms, and efficacy of community policing and its impact on perceived disorder, crime, quality of life in the community, citizens' fear, and satisfaction with the police. It compares traditional and community policing paradigms on three dimensions: goal, measurement of…

High versus Low Theoretical Fidelity Pedometer Intervention Using Social-Cognitive Theory on Steps and Self-Efficacy

ERIC Educational Resources Information Center

Raedeke, Thomas D.; Dlugonski, Deirdre

2017-01-01

Purpose: This study was designed to compare a low versus high theoretical fidelity pedometer intervention applying social-cognitive theory on step counts and self-efficacy. Method: Fifty-six public university employees participated in a 10-week randomized controlled trial with 2 conditions that varied in theoretical fidelity. Participants in the…

The Effect of a Campaign Internship on Political Efficacy and Trust

ERIC Educational Resources Information Center

Mariani, Mack; Klinkner, Philip

2009-01-01

This study examines the effect of a 10-week campaign internship course on political efficacy and trust. We compared changes in these key political attitudes between a group of 33 undergraduate students in a campaign internship course and a control group of 65 students taking government courses. A multiple regression analysis indicates that…

The Effects of Online Homework on Achievement and Self-Efficacy of College Algebra Students

ERIC Educational Resources Information Center

Brewer, David Shane

2009-01-01

This study compared the effectiveness, in terms of mathematical achievement and mathematics self-efficacy, of online homework to textbook homework over an entire semester for 145 students enrolled in multiple sections of college algebra at a large community college. A quasi-experimental, posttest design was used to analyze the effect on…

Being Nontraditional and Learning Online: Assessing the Psychosocial Learning Environments, Self-Efficacy, and Affective Outcomes among College Student Groups

ERIC Educational Resources Information Center

Ashford, Roslyn La'Toya

2014-01-01

The study compared traditional and nontraditional students' attitudes about the psychosocial learning environment and their influence on self-efficacy, enjoyment of online learning, and student satisfaction by using Moos' (1979) Model of Environmental and Personal Variables and the three dimensions of social climate as its theoretical framework.…

Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

ERIC Educational Resources Information Center

McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

2008-01-01

No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

Identifying Taiwanese University Students' Physics Learning Profiles and Their Role in Physics Learning Self-Efficacy

ERIC Educational Resources Information Center

Lin, Tzung-Jin; Liang, Jyh-Chong; Tsai, Chin-Chung

2015-01-01

The main purposes of this study were to identify Taiwanese university students' physics learning profiles in terms of their critical conceptions of learning physics and to compare their physics learning self-efficacy with the different learning profiles. A total of 250 Taiwanese undergraduates who were majoring in physics participated in this…

Substituted N-aryl-6-pyrimidinones: A new class of potent, selective, and orally active p38 MAP kinase inhibitors

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

Devadas, Balekudru; Selness, Shaun R.; Xing, Li

2012-02-28

A novel series of highly potent and selective p38 MAP kinase inhibitors was developed originating from a substituted N-aryl-6-pyrimidinone scaffold. SAR studies coupled with in vivo evaluations in rat arthritis model culminated in the identification of 10 with excellent oral efficacy. Compound 10 exhibited a significantly enhanced dissolution rate compared to 1, translating to a high oral bioavailability (>90%) in rat. In animal studies 10 inhibited LPS-stimulated production of tumor necrosis factor-{alpha} in a dose-dependent manner and demonstrated robust efficacy comparable to dexamethasone in a rat streptococcal cell wall-induced arthritis model.

The efficacy and safety of blonanserin compared with haloperidol in acute-phase schizophrenia: a randomized, double-blind, placebo-controlled, multicentre study.

PubMed

Garcia, Esther; Robert, Marta; Peris, Francesc; Nakamura, Hiroshi; Sato, Noriko; Terazawa, Yoshikatsu

2009-01-01

Blonanserin is a novel atypical antipsychotic agent with potent dopamine D(2) and serotonin 5-HT(2) antagonist properties. It may potentially have a lower incidence of adverse events than other antipsychotic agents. To determine the efficacy and safety of three doses of blonanserin compared with placebo and haloperidol in patients with acute-phase schizophrenia. This was a 6-week, randomized, double-blind, placebo- and haloperidol-controlled, international, multicentre study. Patients with an acute exacerbation of their schizophrenia, with a Positive and Negative Syndrome Scale (PANSS) score >/=70 and a Clinical Global Impression - Severity of Illness (CGI-S) score >/=4 ('moderately ill') [with no decrease >/=20% or >/=1 point, respectively, during the wash-out period] were randomized into one of five treatment groups (blonanserin 2.5, 5 or 10 mg, haloperidol 10 mg or placebo once daily). Patients were assessed weekly for clinical efficacy, adverse events, extrapyramidal symptoms (EPS) and drug compliance, and were assessed biweekly for other safety variables. All 307 randomized patients received at least one dose of study medication and 228 (74.3%) completed the study. The mean reduction in PANSS total score at week 6 was significantly greater with all active treatments compared with placebo (-12.58; p < 0.001); blonanserin 10 mg was significantly superior to blonanserin 2.5 mg (-30.18 vs -20.6; p < 0.001), but blonanserin 5 mg (-27.19) and haloperidol 10 mg (-28.16) were not. All active treatments showed greater efficacy against the positive symptoms of schizophrenia, and blonanserin (5 and 10 mg) was more effective against the negative symptoms than haloperidol. Blonanserin was well tolerated at all doses and there was no evidence of clinically important weight gain, orthostatic hypotension, corrected QT interval prolongation or clinically relevant changes in laboratory test results. Haloperidol caused persistent elevation in prolactin levels, but this was not seen with any dose of blonanserin throughout the study period. There was a lower incidence of EPS with blonanserin 10 mg (26.6%) than with haloperidol 10 mg (53.3%). Blonanserin was effective in the treatment of acute schizophrenia and showed greater efficacy in negative symptoms compared with placebo and haloperidol. Blonanserin was well tolerated and its safety profile compared favourably with haloperidol, particularly with respect to prolactin elevation and EPS frequency.

SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study in the Environment and During Challenge in the Controlled Adverse Environment Model.

PubMed

Petrov, Anton; Perekhvatova, Natalia; Skulachev, Maxim; Stein, Linda; Ousler, George

2016-01-01

This Phase 2 clinical trial assessed the efficacy and safety of the novel antioxidative, renewable compound SkQ1 for topical treatment of dry eye signs and symptoms. In a single-center, randomized, double-masked, placebo-controlled, 29-day study, 91 subjects with mild to moderate dry eye instilled the study drug twice daily and recorded dry eye symptoms daily. Subjects were randomized 1:1:1 into one of three ophthalmic solution treatment groups: SkQ1 1.55 µg/mL, SkQ1 0.155 µg/mL, or 0.0 µg/mL (placebo). Subjects were exposed to a controlled adverse environment chamber at 3 of the 4 study visits (Day -7, Day 1, and Day 29). Investigator assessments occurred at all study visits. SkQ1 was safe and efficacious in treating dry eye signs and symptoms. Statistically significant improvements with SkQ1 compared to placebo occurred for the dry eye signs of corneal fluorescein staining and lissamine green staining in the central region and lid margin redness, and for the dry eye symptoms of ocular discomfort, dryness, and grittiness. In addition, SkQ1 demonstrated greater efficacy compared to placebo, although the differences were not statistically significant, for corneal fluorescein staining in other regions and/or time points (total staining score, central region, corneal sum score, and temporal region), lissamine green staining for the central and nasal regions, and blink rate scores. This Phase 2 study indicated that SkQ1 is safe and efficacious for the treatment of dry eye signs and symptoms and supported previous study results. Clinicaltrials.gov identifier: NCT02121301. Miotech S.A.

Efficacy of topical recombinant human platelet-derived growth factor for treatment of diabetic lower-extremity ulcers: Systematic review and meta-analysis.

PubMed

Zhao, Xiao-hong; Gu, Hai-feng; Xu, Zhe-rong; Zhang, Qin; Lv, Xue-ying; Zheng, Xiao-jun; Yang, Yun-mei

2014-10-01

Recombinant human platelet-derived growth factor (rhPDGF) is used topically in the treatment of diabetic lower-extremity ulcers. There have been few meta-analyses of the efficacy of rhPDGF in this treatment context. The aim of this study was to perform an updated systematic review and meta-analysis to assess the clinical efficacy of rhPDGF in the treatment of diabetic lower-extremity ulcers. We searched the MEDLINE, Cochrane Library, EMBASE and Web of Knowledge databases up to April 30, 2014. Studies were identified and selected, and data were extracted by two independent reviewers. The primary efficacy outcome was complete healing rate. Adverse events were also assessed. The studies were evaluated for quality and publication bias. A total of 6 randomized controlled trials including 992 patients were selected from 173 identified studies. The studies compared rhPDGF treatment in the context of standard of care (SOC) to placebo or SOC alone. In the absence of study heterogeneity, a fixed-effects model was performed, and the combined odds ratio (OR) indicated a significantly greater complete healing rate in patients treated with rhPDGF compared to placebo or SOC alone. The ORs ranged from 0.58 to 2.77, with a combined OR of 1.53 (95% CI = 1.14 to 2.04, p = 0.004). A sensitivity analysis (leave-one-out method) indicated good study reliability, and a funnel plot with Egger test showed no publication bias. These results indicate that rhPDGF is efficacious in the treatment of diabetic lower-extremity ulcers. Copyright © 2014 Elsevier Inc. All rights reserved.

Comparative efficacy and safety of oxcarbazepine versus divalproex sodium in the treatment of acute mania: a pilot study.

PubMed

Kakkar, Ashish Kumar; Rehan, H S; Unni, K E S; Gupta, Neeraj Kumar; Chopra, Deepti; Kataria, Dinesh

2009-04-01

This study compared the efficacy and safety of oxcarbazepine and divalproex sodium in acute mania patients. In this 12 week, randomized, double-blind pilot study, 60 patients diagnosed with acute mania (DSM-IV) and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexibly dosed oxcarbazepine (1,000-2,400 mg/day) or divalproex (750-2,000 mg/day). The mean decrease in the YMRS score from baseline was used as the main outcome measure of response to treatment. A priori protocol-defined threshold scores were or=15 for relapse. Number of patients showing adequate response and the time taken to achieve improvement was compared. Adverse events were systematically recorded throughout the study. Over 12 weeks, mean improvement in YMRS scores was comparable for both the groups including the mean total scores as well as percentage fall from baseline. There were no significant differences between treatments in the rates of symptomatic mania remission (90% in divalproex and 80% in oxcarbazepine group) and subsequent relapse. Median time taken to symptomatic remission was 56 days in divalproex group while it was 70 days in the oxcarbazepine group (p=0.123). A significantly greater number of patients in divalproex group experienced one or more adverse drug events as compared to patients in the oxcarbazepine group (66.7% versus 30%, p<0.01). Oxcarbazepine demonstrated comparable efficacy to divalproex sodium in the management of acute mania. Also the overall adverse event profile was found to be superior for oxcarbazepine.

Self-Efficacy Manipulation Influences Physical Activity Enjoyment in Chinese Adolescents.

PubMed

Hu, Liang; Cheng, Shoubin; Lu, Jiaying; Zhu, Lele; Chen, Ling

2016-02-01

In this study, we examined the effect of the manipulation of exercise self-efficacy on the enjoyment of physical activity in a sample of 44 Chinese adolescents (age = 14.27 ± .87 y), including 22 boys and 22 girls. The participants were randomized into a low-efficacy or high-efficacy condition, and their self-efficacy beliefs for engaging in moderate-intensity physical activity were manipulated by providing false feedback after a submaximal exercise test. The participants' self-efficacy was measured and compared before and after the exercise test and the participants' enjoyment of physical activity was assessed after the exercise test. It was found that exercise self-efficacy was successfully manipulated in the expected direction in both conditions, which significantly influenced the participants' enjoyment of physical activity. After the exercise test, the participants in the low-efficacy condition reported lower enjoyment scores relative to the high-efficacy participants. These results suggest that self-efficacy may have an important influence on the enjoyment of physical activity among Chinese adolescents. We recommend that physical activity promotion programs should be tailored to enhance adolescents' self-efficacy beliefs and enjoyment of the experience of physical activity.

Caregiver self-efficacy, ethnicity, and kinship differences in dementia caregivers.

PubMed

Depp, Colin; Sorocco, Kristen; Kasl-Godley, Julia; Thompson, Larry; Rabinowitz, Yaron; Gallagher-Thompson, Dolores

2005-09-01

The authors sought to determine the effect of kinship status (daughters versus wives) and ethnicity (Hispanic/Latino versus Caucasian) on self-efficacy to perform tasks relevant to caregiving in a sample of family caregivers for people with memory problems. Baseline data were collected from 238 female caregivers who participated in an intervention program. Ethnic and kin relationship groups were compared on measures of caregiver self-efficacy, acculturation within the Hispanic/Latino sample, and the relationship of self-efficacy to key outcome variables. Hispanics/Latinos reported higher self-efficacy on two of three self-efficacy subscales (Responding to Disruptive Behaviors and Controlling Negative Thoughts About Caregiving). Daughters reported higher self-efficacy on all three self-efficacy scales. Among Hispanics/Latinos, acculturation did not relate strongly to self-efficacy. Caucasian and spousal caregivers appeared to make more generalized appraisals about caregiving. Higher self-efficacy among Hispanic/Latino caregivers may relate to cultural values about caregiving and/or ethnic differences in appraisal. Wives may be more at risk for low self-efficacy, which may relate to greater role frustration and distress. This study highlights the heterogeneity among caregivers in their experience of caregiving.

Clinical study on the efficacy of Amoebex (coded herbal drug) compared with Metronidazole for the treatment of Amoebic dysentery.

PubMed

Shah, Syed MuhammadAli; Usmanghani, Khan; Akhtar, Naveed; Akram, Muhammad; Asif, Hafiz Muhammad; Hasan, Muhammad Mohtasheemul

2016-11-01

Amoebiasisis an infectious disease, which originated with the single-celled parasitic protozoan Entamoeba histolytica. The parasitic amoeba infects the liver and intestine and may cause mild diarrhea and serious dysentery with bloody and mucoid stool. A study was conducted to evaluate the efficacy of Amoebex (400mg), a herbal formulation for the treatment of amoebiasis infections as compared to that of Metronidazole (400mg). The therapeutic evaluations of these medicines were carried out on 184 clinically diagnosed cases of the amoebiasis infection. Sample sizes of Ameobex for this study included a total of 93 patients and for Metronidazole a total of 91 were registered and treated. Comparison of the data recorded for the participants relating to sign and symptoms variables showed significant differences of efficacy between test and control groups (p<0.0357) and no side effects were at all recorded in test group. According to observation, there was a difference in the overall clinical success of both treatment groups, however, the efficacy of the test treated medication (Amoebex) was superior to that of Metronidazole as (p<0.03), and on the basis of the statistical analysis done by the chi square test, the null hypothesis was rejected. `It is clearly evident that Amoebex possesses therapeutic value for the treatment of amoebiasis associated symptoms but also the eradication rate of amoebiasis is superior by Amoebex as compared to that of Metronidazole (Control drug).

In vitro and in vivo anthelmintic activity of seed extract of Coriandrum sativum compared to Niclosamid against Hymenolepis nana infection.

PubMed

Hosseinzadeh, Samaneh; Ghalesefidi, Maryam Jamshidian; Azami, Mehdi; Mohaghegh, Mohammad Ali; Hejazi, Seyed Hossein; Ghomashlooyan, Mohsen

2016-12-01

Phytotherapy can be an alternative for the control of gastrointestinal parasites in human and animals. Coriander ( Coriandrum sativum L.) is a medicinal plant which grown as a spice crop all over the world. The seeds of this plant have been used to treat parasitic disease, indigestion, diabetes, rheumatism and pain in the joints. This study was carried out to compare the efficacy of Niclosamid and alcoholic seed extract of C. sativum on Hymenolepis nana infection, in vivo and vitro. For in vivo study, Balb/c mice were used, to compare the efficacy of 50 mg/kg body weight (B.W) of Niclosamid with different doses of alcoholic extracts of C. sativum (250, 500, and 750 mg/kg B.W). It was found that the efficacy of Niclosamid had reached 100 % after 11 days post treatment, while the efficacy of 500 and 750 mg/kg B.W of C. sativum reached to 100 % after 15 days after treatment. For in vitro study, special nutrient broth media was used. It was found that the addition of 1000 mg/ml of Niclosamid had paralyzed and killed worms within 5 min, while C. sativum killed them within 30 min. Our results showed that extract of C. sativum has good effect against H. nana and could be use in traditional medicine for treatment of parasitic disease.

Engagement, Flow, Self-Efficacy, and Eustress of University Students: A Cross-National Comparison Between the Philippines and Argentina.

PubMed

Mesurado, Belén; Richaud, María Cristina; Mateo, Niño José

2016-01-01

This study examined how self-efficacy, eustress, and flow interact with academic engagement. First, it aimed to test a theoretical model that proposes that self-efficacy and eustress promote both flow and engagement and that, in turn, the state of flow promotes academic engagement in undergraduate student. We hypothesized that the theoretical model would be invariant for two countries: the Philippines and Argentina. Secondly, this research aimed to compare the levels of self-efficacy, eustress, study-flow and academic engagement experiences in students from both countries. One hundred seventy-six Filipinos and 171 Argentinean students participated in the study by completing inventories using the Utrecht Student Engagement Scale (Schaufeli, Martínez, et al., 2002), Optimal Experience Survey (Mesurado, 2008), Self-efficacy Scale (O'Sullivan, 2011), and Eustress Scale (O'Sullivan, 2011). Results show that the theoretical model fits the data well in both countries and is invariant across the Philippines and Argentina. Self-efficacy has a positive effect on flow and engagement, whereas eustress has a significant positive relationship with flow but is not directly associated with engagement. However, eustress has an indirect effect, through flow, on student engagement. On the other hand, there are different levels of engagement, flow, self-efficacy, and eustress. Argentinean students scored higher on absorption, dedication, self-efficacy, and flow. Filipino students, meanwhile, scored higher on eustress.

A brief intervention changing oral self-care, self-efficacy, and self-monitoring.

PubMed

Schwarzer, Ralf; Antoniuk, Agata; Gholami, Maryam

2015-02-01

The roles of self-efficacy and self-monitoring as proximal predictors of dental flossing frequency are studied in the context of an oral health intervention. A study among 287 university students, aged 19 to 26 years, compared an intervention group that received a brief self-regulatory treatment, with a passive and an active control group. Dental flossing, self-efficacy, and self-monitoring were assessed at baseline and 3 weeks later. The intervention led to an increase in dental flossing regardless of experimental condition. However, treatment-specific gains were documented for self-efficacy and self-monitoring. Moreover, changes in the latter two served as mediators in a path model, linking the intervention with subsequent dental flossing and yielding significant indirect effects. Self-efficacy and self-monitoring play a mediating role in facilitating dental flossing. Interventions that aim at an improvement in oral self-care should consider using these constructs. Statement of contribution What is already known on this subject? The adoption and maintenance of oral self-care can be facilitated by a number of social-cognitive variables. Interventions that include planning, action control, or self-efficacy components have been shown to improve dental flossing. In one recent study on flossing in adolescent girls, planning intervention effects were mediated by self-efficacy. What does this study add? Self-monitoring is associated with better oral self-care. A 10-min intervention improves self-efficacy and self-monitoring. Self-efficacy and self-monitoring operate as mediators between treatment and flossing. © 2014 The British Psychological Society.

Are all first-generation antipsychotics equally effective in treating schizophrenia? A meta-analysis of randomised, haloperidol-controlled trials.

PubMed

Dold, Markus; Tardy, Magdolna; Samara, Myrto T; Li, Chunbo; Kasper, Siegfried; Leucht, Stefan

2016-04-01

Narrative, unsystematic reviews revealed no differences in efficacy between the various first-generation antipsychotics (FGAs) resulting in the psychopharmacological assumption of comparable efficacy between the different FGAs. We sought to determine if the assumption of comparable efficacy of all FGAs can be regarded as evidence-based using meta-analytic statistics. A systematic literature survey (Cochrane Schizophrenia Group trial register) was applied to identify all RCTs that compared oral haloperidol with another oral FGA in schizophrenia. Primary outcome was dichotomous treatment response. Secondary outcomes were symptom severity measured by rating scales, discontinuation rates, and specific adverse effects. Altogether, 79 RCTs with 4343 participants published between 1962 and 1999 were included. We found a significant between-group difference only between haloperidol and nemonapride, but not for the remaining 19 investigated FGAs. There were no significant differences for discontinuation rates. As most of the single meta-analytic comparisons can be regarded as underpowered, the evidence for the assumption of comparable efficacy of all FGAs is inconclusive. We therefore cannot confirm or reject the statements of previous narrative, unsystematic reviews in this regard. Our findings were limited by the small sample size in the individual comparisons and the low methodological quality in many included studies.

Understanding exercise self-efficacy and barriers to leisure-time physical activity among postnatal women.

PubMed

Cramp, Anita G; Bray, Steven R

2011-07-01

Studies have demonstrated that postnatal women are at high risk for physical inactivity and generally show lower levels of leisure-time physical activity (LTPA) compared to prepregnancy. The overall purpose of the current study was to investigate social cognitive correlates of LTPA among postnatal women during a 6-month period following childbirth. A total of 230 women (mean age = 30.9) provided descriptive data regarding barriers to LTPA and completed measures of LTPA and self-efficacy (exercise and barrier) for at least one of the study data collection periods. A total of 1,520 barriers were content analyzed. Both exercise and barrier self-efficacy were positively associated with subsequent LTPA. Exercise self-efficacy at postnatal week 12 predicted LTPA from postnatal weeks 12 to 18 (β = .40, R (2) = .18) and exercise self-efficacy at postnatal week 24 predicted LTPA during weeks 24-30 (β = .49, R (2) = .30). Barrier self-efficacy at week 18 predicted LTPA from weeks 18 to 24 (β = .33, R (2) = .13). The results of the study identify a number of barriers to LTPA at multiple time points closely following childbirth which may hinder initiation, resumption or maintenance of LTPA. The results also suggest that higher levels of exercise and barrier self-efficacy are prospectively associated with higher levels of LTPA in the early postnatal period. Future interventions should be designed to investigate causal effects of developing participants' exercise and barrier self-efficacy for promoting and maintaining LTPA during the postnatal period.

Safety and efficacy of bridging with low molecular weight heparins: a systematic review and partial meta-analysis.

PubMed

Eijgenraam, Pieter; ten Cate, Hugo; Ten Cate-Hoek, Arina

2013-01-01

Surgical interventions in patients on long term vitamin K antagonist (VKA) treatment create a dilemma; periprocedural interruption of anticoagulation raises the risk of thrombosis, while continuation raises the risk of bleeding. The anticoagulation- free interval is minimized by "bridging" with parenteral anticoagulants. The efficacy and safety of bridging with low molecular weight heparins (LMWH) has however not been unequivocally established. We performed an EMBASE and MEDLINE search for studies that compared bridging anticoagulation with continuation or cessation of VKA without bridging; with thromboembolism (TE) and bleeding as outcomes. We identified 878 articles and finally selected 17. Results of individual studies were pooled. None of the included studies reported significant differences in incidence of TEs between the bridging group and the comparator group; 4 out of 13 studies reported zero TEs. Heparin was identified as a risk factor for bleeding in multivariable adjusted analyses in 3 studies on pacemaker/implantable cardioverter defibrillator (PM/ICD) surgery. In 5 studies (different types of surgery) with unadjusted analyses, bridging was compared to warfarin cessation: 3 studies reported null results for bleeding; 2 studies identified bridging as a risk factor. We pooled a subset of 6 studies regarding postoperative bleeding after PM/ICD surgery and found a relative risk (RR) of 3.03 (95% confidence interval (CI), 1.86-4.95) for bridging compared to continuation of VKA. While the antithrombotic efficacy of bridging with LMWH has not been demonstrated, increased bleeding risk is observed in different types of surgery. PM/ICD surgery can be safely performed on continued VKA.

Field trial assessment of ivermectin pharmacokinetics and efficacy against susceptible and resistant nematode populations in cattle.

PubMed

Canton, Candela; Canton, Lucila; Domínguez, María Paula; Moreno, Laura; Lanusse, Carlos; Alvarez, Luis; Ceballos, Laura

2018-05-30

The study compared the pharmacokinetic (PK) behaviour and anthelmintic efficacy against susceptible and resistant nematodes following subcutaneous (SC) and oral administration of ivermectin (IVM) to cattle. Six commercial farms were involved: Farms 1 and 2 (IVM-susceptible nematode population) and Farms 3, 4, 5 and 6 (IVM-resistant nematode population). On each farm, forty-five calves naturally infected with gastrointestinal (GI) nematodes were randomly allocated into three groups (n = 15): untreated control, IVM SC administration, and IVM oral administration (both at 0.2 mg/kg). PK assessment (plasma and faeces) was performed on Farm 1. Efficacy was determined by Faecal Egg Count Reduction Test. IVM systemic availability upon SC administration (421 ± 70.3 ng·d/mL) was higher (P < 0.05) compared to the oral treatment (132 ± 31.3 ng·d/mL). However, higher (P < 0.05) faecal IVM concentrations were observed following oral treatment (9896 ± 1931 ng·d/mL) compared to SC administration (4760 ± 924 ng·d/mL). Similar (91-93%) IVM efficacy was observed on Farms 1 and 2 by both routes. Efficacy against resistant nematodes was slightly higher on Farms 3 and 4 after the oral (63 and 82%, respectively) compared to the SC (36 and 68%, respectively) treatment. However, there was complete therapeutic failure (0% efficacy) on Farm 5 and a very low response on Farm 6 (40 and 41% for SC and oral administration, respectively). Although larger faecal concentrations following IVM oral administration may increase drug exposure of GI adult worms, this does not always improve efficacy against resistant nematodes. The potential therapeutic advantages of oral treatments should be cautiously assessed, especially in presence of anthelmintic resistance. Copyright © 2018 Elsevier B.V. All rights reserved.

Comparative efficacy of a new spot-on combination product containing selamectin and sarolaner (Stronghold®Plus) versus fluralaner (Bravecto®) against induced infestations with Ixodes ricinus ticks on cats.

PubMed

Geurden, Thomas; Borowski, Stasia; Wozniakiewicz, Magda; King, Vickie; Fourie, Josephus; Liebenberg, Julian

2017-06-29

Ticks are increasingly reported on cats worldwide, with Ixodes ricinus being a relevant species across Europe and in near by areas of North Africa and the Middle East. Yet there are few acaracidal products with proven efficacy approved for use in cats. The objective of this study was to compare the efficacy of a new spot-on formulation containing selamectin and sarolaner with a topical application of fluralaner (Bravecto®) against Ixodes ricinus ticks on cats. To that end, twenty-four (24) cats were randomly allocated to one of three treatment groups. The cats in the control group remained untreated. Cats in group 2 were treated with selamectin/sarolaner (Stronghold®Plus; Zoetis) at the minimum recommended dose of 1.0 mg/kg sarolaner and 6.0 mg/kg selamectin on Days 0, 30 and 60. The cats in group 3 received a fluralaner treatment (Bravecto®spot-on solution for cats, MSD) at the minimum recommended dose of 40.0 mg/kg on Day 0. Cats were infested with 50 (± 4) viable, adult, unfed I. ricinus ticks on Days 26, 54, 82 and 89 and ticks were removed for counting 48 h (± 2 h) later. Three monthly treatments with selamectin/sarolaner provided high and consistent efficacy against I. ricinus for the entire duration of the study period. In contrast, the efficacy of fluralaner declined in the second month after treatment and was below the efficacy threshold of 90% on Days 56, 84 and 91. The percentage efficacy against I. ricinus was numerically higher in the selemectin/sarolaner treated group than in the fluralaner-treated group on Days 56, 84 and 91. Furthermore, greasiness and spiking of the hair, as well as white deposits were frequently observed in the fluralaner-treated cats. The results of the present study confirm the high and consistent efficacy of a new spot-on combination product containing selamectin and sarolaner against I. ricinus in cats, and indicate a decline in fluralaner efficacy during the 91 day period after treatment.

[Mirtazapine versus other antidepressive agents for depression].

PubMed

Knud Larsen, Jens

2012-11-12

A Cochrane analysis compared efficacy and side effects of mirtazapine with other antidepressants. After six weeks of treatment no reliable difference of efficacy between mirtazapine, selective serotonin reuptake inhibitors (SSRI), noradrenaline reuptake inhibitors or tricyclic antidepressants was found. The side effects like increased sleep and weight gain were compared by treatment with mirtazapine and treatment with SSRI antidepressants. The very fact of the sleep effect and the fast onset of action have probably increased the effect size compared with SSRI antidepressants. The results of the Cochrane analysis cannot for certain be generalized to inpatients, as other studies have found tricyclic antidepressants to be especially effective.

Efficacy or inefficacy, that's the question: burnout and work engagement, and their relationships with efficacy beliefs.

PubMed

Schaufeli, Wilmar B; Salanova, Marisa

2007-06-01

We challenge traditional view that lack of efficacy - measured with the corresponding reversed efficacy scale (Maslach Burnout Inventory, MBI) - is a burnout dimension. Instead, we claim that in addition to exhaustion and cynicism, inefficacy - measured with a newly developed scale - characterizes burnout. MBI-efficacy is apparently related to work engagement, considered as the positive antithesis of burnout. We performed Structural Equation Modeling in two samples of Spanish (n=239) and Dutch (n=235) university students, and two Spanish employee samples, working in various jobs (n=342) and working with information and communication technologies (n=283). Our expectations were largely confirmed: (1) compared with efficacy beliefs inefficacy beliefs relate more strongly to the other two burnout components; (2) the alternative three-factor burnout model including inefficacy fits better to the data than the traditional model including efficacy; (3) a model with inefficacy loading on burnout and efficacy loading on engagement fits the data. It is suggested that an inefficacy scale rather than a reversed efficacy scale should be used to assess burnout in future studies.

Methotrexate use in allergic contact dermatitis: a retrospective study.

PubMed

Patel, Ashaki; Burns, Erin; Burkemper, Nicole M

2018-03-01

Methotrexate, a folate antimetabolite, is used to treat atopic dermatitis and psoriasis. Although methotrexate's therapeutic efficacy has been noted in the literature, there are few data on the efficacy of methotrexate treatment for allergic contact dermatitis. To evaluate the efficacy and tolerability of methotrexate in treating allergic contact dermatitis at a single institution, and also to assess methotrexate efficacy in patients with chronic, unavoidable allergen exposure. We performed a retrospective chart review of 32 patients diagnosed with allergic contact dermatitis by positive patch test reactions, and who received treatment with methotrexate from November 2010 to November 2014. Demographic and treatment-associated data were collected from electronic medical records. Ten patients were identified as allergen non-avoiders secondary to their occupation, and were subgrouped as such. Seventy-eight per cent (25/32) of patients showed either a partial or a complete response. Methotrexate had a comparable efficacy rate in the allergen non-avoiders subset, at 10 of 10. Of the 32 patients, 23% (5/22) had complete clearance of their dermatitis, and 1/10 of allergen non-avoiders had complete clearance of their dermatitis. Methotrexate is a well-tolerated and effective treatment for allergic contact dermatitis, and shows comparable efficacy to immunomodulatory agents such as cyclosporine and azathioprine, with robust efficacy despite persistent allergen exposure in patients with allergic contact dermatitis. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Persistent differences in asthma self-efficacy by race, ethnicity, and income in adults with asthma.

PubMed

Ejebe, Ifna H; Jacobs, Elizabeth A; Wisk, Lauren E

2015-02-01

The objective of this population-based study was to determine if and to what extent there are differences in asthma self-efficacy by race/ethnicity and income, and whether health status, levels of acculturation, and health care factors may explain these differences. We conducted a secondary data analysis of asthma self-efficacy using the 2009 and 2011-2012 California Health Interview Survey, in adults with asthma (n=7874). In order to examine if and how the effect of race/ethnicity and income on asthma self-efficacy may have been altered by health status, acculturation, and health care factors, we used staged multivariable logistic regression models. We conducted mediation analyses to evaluate which of these factors might mediate disparities in self-efficacy by race/ethnicity and income. 69.8% of adults reported having high asthma self-efficacy. Latinos (OR 0.66; 95% CI 0.51-0.86), African-Americans (OR 0.50; 95% CI 0.29-0.83), American Indian/Alaskan Natives (OR 0.55; 95% CI 0.31-0.98) and Asian/Pacific Islanders (OR 0.34; 95% CI 0.23-0.52) were less likely to report high self-efficacy compared to Whites. Individuals with income below the federal poverty level (OR 0.56; 95% CI 0.40-0.78) were less likely to report high self-efficacy compared to higher income individuals. The relationship between income and self-efficacy was no longer significant after further adjustment for health care factors; however, the differences in race and ethnicity persisted. Receiving an asthma management plan mediated the relationship in certain subgroups. Addressing modifiable health care factors may play an important role in reducing disparities in asthma self-efficacy.

A meta-analytic review of the relationship of cancer coping self-efficacy with distress and quality of life

PubMed Central

Chirico, Andrea; Lucidi, Fabio; Merluzzi, Thomas; Alivernini, Fabio; De Laurentiis, Michelino; Botti, Gerardo; Giordano, Antonio

2017-01-01

Self-efficacy for coping with cancer is a specific construct that refers to behaviors that occur in the course of dealing with a cancer diagnosis, cancer treatments, and transitioning to survivorship. One of the more widely used measures of self-efficacy for coping strategies with cancer is the Cancer Behavior Inventory. The following general questions provide a framework for this research: 1. Is self-efficacy for coping with cancer related to distress and quality of life of a cancer patient?. 2. Do self-efficacy for coping with cancer and the target psychological outcomes (i.e., distress and quality of life) change in longitudinal studies, with or without intervention? One-hundred eighty studies cited the different versions of the Cancer Behavior Inventory and 47 used the scale. Result showed an inverse relationship between self-efficacy for coping with cancer and distress, and a positive relationship between self-efficacy for coping with cancer and Quality of Life, both with a large effect size. The strong relationship of self-efficacy and outcomes, resulted of the specificity of the instrument, which targets specific coping strategies that are closely aligned with positive outcomes in adjusting to cancer. However, the results are consistent with the theory, which states that compared to those with low efficacy, highly efficacious people demonstrate less anxiety and better adjustment in stressful situations and consistent with prior results in which self-efficacy is positively related to quality of life. PMID:28404938

GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial

PubMed Central

2014-01-01

Background Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT. Methods/design A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n = 128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation. Discussion This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD. Trial registration German Clinical Trial Registration (DRKS): DRKS00005025 PMID:24476555

Rabeprazole vs esomeprazole in non-erosive gastro-esophageal reflux disease: A randomized, double-blind study in urban Asia

PubMed Central

Fock, KM; Teo, EK; Ang, TL; Chua, TS; Ng, TM; Tan, YL

2005-01-01

AIM: Gastro-esophageal reflux disease (GERD) is becoming increasingly common in Asia. Data on the efficacy of proton pump inhibitors in patients with non-erosive GERD (NERD) in Asia is lacking. This double-blind study compared the efficacy and safety of rabeprazole with esomeprazole in relief of symptoms in patients with NERD. METHODS: One hundred and thirty-four patients with reflux symptoms of NERD and normal endoscopy were randomized to receive rabeprazole 10 mg or esomeprazole 20 mg once daily for 4 wk. Symptoms were recorded in a diary and changes in severity of symptoms noted. RESULTS: At 4 wk of treatment, rabeprazole 10 mg and esomeprazole 20 mg were comparable with regards to the primary endpoint of time to achieve 24-h symptom-free interval for heartburn 8.5 d vs 9 d and regurgitation 6 d vs 7.5 d. Rabeprazole and esomeprazole were also similarly efficacious in term of patient’s global evaluation with 96% of patients on rabeprazole and 87.9% of patients on esomeprazole, reporting that symptoms improved (P = NS). Satisfactory relief of day- and night-time symptoms was achieved in 98% of patients receiving rabeprazole and 81.4% of patients receiving esomeprazole. Adverse events were comparable in both groups (P = NS). CONCLUSION: Rabeprazole 10 mg has a similar efficacy and safety profile in Asians with NERD as esomeprazole 20 mg. Further study is necessary to investigate whether the small differences between the two drugs seen in this study are related to the improved pharmacodynamic properties of rabeprazole. Both drugs were well tolerated. PMID:15918196

Rabeprazole vs esomeprazole in non-erosive gastro-esophageal reflux disease: a randomized, double-blind study in urban Asia.

PubMed

Fock, K M; Teo, E K; Ang, T L; Chua, T S; Ng, T M; Tan, Y L

2005-05-28

Gastro-esophageal reflux disease (GERD) is becoming increasingly common in Asia. Data on the efficacy of proton pump inhibitors in patients with non-erosive GERD (NERD) in Asia is lacking. This double-blind study compared the efficacy and safety of rabeprazole with esomeprazole in relief of symptoms in patients with NERD. One hundred and thirty-four patients with reflux symptoms of NERD and normal endoscopy were randomized to receive rabeprazole 10 mg or esomeprazole 20 mg once daily for 4 wk. Symptoms were recorded in a diary and changes in severity of symptoms noted. At 4 wk of treatment, rabeprazole 10 mg and esomeprazole 20 mg were comparable with regards to the primary endpoint of time to achieve 24-h symptom-free interval for heartburn 8.5 d vs 9 d and regurgitation 6 d vs 7.5 d. Rabeprazole and esomeprazole were also similarly efficacious in term of patient's global evaluation with 96% of patients on rabeprazole and 87.9% of patients on esomeprazole, reporting that symptoms improved (P = NS). Satisfactory relief of day- and night-time symptoms was achieved in 98% of patients receiving rabeprazole and 81.4% of patients receiving esomeprazole. Adverse events were comparable in both groups (P = NS). Rabeprazole 10 mg has a similar efficacy and safety profile in Asians with NERD as esomeprazole 20 mg. Further study is necessary to investigate whether the small differences between the two drugs seen in this study are related to the improved pharmacodynamic properties of rabeprazole. Both drugs were well tolerated.

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

PubMed Central

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

2016-01-01

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

The Effect of Self-Efficacy on Return-to-Work Outcomes for Workers with Psychological or Upper-Body Musculoskeletal Injuries: A Review of the Literature.

PubMed

Black, Oliver; Keegel, Tessa; Sim, Malcolm R; Collie, Alexander; Smith, Peter

2018-03-01

Purpose Work absence can result in substantial losses to the economy and workers. As a result, identifying modifiable factors associated with return-to-work (RTW) following an injury or illness is the focus of many empirical investigations. Self-efficacy, the belief about one's ability to undertake behaviours to achieve desired goals, has been identified as an important factor in RTW for injured workers. This paper systematically reviewed the literature on the association between self-efficacy and RTW outcomes for workers with an upper-body musculoskeletal injury or psychological injury. Methods A systematic search was conducted across five databases using two main search concepts- 'self-efficacy' and 'RTW'. After removing duplicates, our search strategy identified 836 studies, which were screened for relevance using titles and abstracts. Results A two stage screening process reduced the study pool to six studies using psychological injury cohorts and three using upper-body musculoskeletal (UB-MSK) cohorts. Eight cohorts from seven prospective cohort studies and one sample from a randomised control trial (RCT) were subjected to a risk of bias assessment. Higher levels of self-efficacy appeared to have a consistent and positive association with RTW across return-to-work status and work absence outcomes, injury type and follow-up periods. Effect ratios ranged from 1.00 to 5.26 indicating a potentially large impact of self-efficacy on RTW outcomes. The relationship between self-efficacy and RTW strengthened as the domain of self-efficacy became more specific to RTW and job behaviours. Studies assessing workers with psychological injuries were of a lower quality compared to those assessing workers with UB-MSK injuries. Conclusions Higher self-efficacy had consistent positive associations with RTW outcomes. Further empirical research should identify the determinants of self-efficacy, and explore the processes by which higher self-efficacy improves RTW outcomes.

Clinical efficacy of melittin in the treatment of cats infected with the feline immunodeficiency virus.

PubMed

Hartmann, Anja D; Wilhelm, Natalie; Erfle, Volker; Hartmann, Katrin

2016-12-05

The bee venom melittin shows an antiviral efficacy against the human immunodeficiency virus in cell culture. It was shown to be non-toxic for cats. Aim of this pilot study was to investigate the clinical efficacy and side-effects of melittin in cats naturally infected with feline immunodeficiency virus (FIV). The study was performed as a prospective, placebo-controlled double-blinded trial. Twenty cats were included, of which 10 cats each were treated with either melittin (500 µg/kg body weight) or phosphate-buffered saline (placebo) subcutaneously twice per week. During the treatment period of 6 weeks, the cats' general health status, determined by the Karnofsky's score, and the severity of clinical signs (conjunctivitis and stomatitis) using a clinical scoring system were evaluated. Haematology, biochemistry profiles, lymphocyte subpopulations, CD4/CD8 ratio, and pterines (biopterine, 7-xanthopterine) as surrogate parameters were also compared. The general health status and the clinical scores for conjunctivitis and stomatitis improved in cats treated with melittin. A statistically significant improvement however could only be detected for conjunctivitis in cats treated with melittin compared to cats treated with placebo which was likely due to different scores between both groups at the beginning. No influence on the lymphocyte subpopulations, CD4/CD8 ratio, and pterine concentrations was observed. No side effects occurred in this study. In the protocol used in the present study, no significant efficacy of melittin could be detected. However, efficacy of melittin, especially if applied in a higher dosage as in the present study or for a longer period, could be evaluated in further studies. Synergistic effects if used in combination with classic antiretroviral drugs could be an interesting future approach.

The relationship between critical thinking skills and self-efficacy beliefs in mental health nurses.

PubMed

Gloudemans, Henk A; Schalk, René M J D; Reynaert, Wouter

2013-03-01

In the Netherlands, the distinction between Bachelor degree and diploma nursing educational levels remains unclear. The added value of Bachelor degree nurses and how they develop professionally after graduation are subject to debate. The aim of this study is to investigate whether Bachelor degree nurses have higher critical thinking skills than diploma nurses do and whether there is a positive relationship between higher critical thinking skills and self-efficacy beliefs. Outcomes might provide instruments that are helpful in positioning of nursing levels in education and practice. Questionnaire data were used of a sample of 95 registered mental health staff nurses (62 diploma nurses and 33 Bachelor degree nurses). First, ANOVA was performed to test whether the two groups were comparable with respect to elements of work experience. Second, t-tests were conducted to compare the two groups of nurses on self-efficacy, perceived performance and critical thinking outcomes. Third, relationships between the study variables were investigated. Finally, structural equation modelling using AMOS was applied to test the relationships. The hypothesis that Bachelor degree nurses are better critical thinkers than diploma nurses was supported (p<0.01). Years in function turned out to be positively related to self-efficacy beliefs (p<0.01). No significant relation was found between the level of education and self-efficacy beliefs. The results of this study support career development and facilitate more efficient positioning of nursing levels. Copyright © 2012 Elsevier Ltd. All rights reserved.

Lack of efficacy of moclobemide or imipramine in the treatment of recurrent brief depression: results from an exploratory randomized, double-blind, placebo-controlled treatment study.

PubMed

Baldwin, David S; Green, Mary; Montgomery, Stuart A

2014-11-01

'Recurrent brief depression' (RBD) is a common, distressing and impairing depressive disorder for which there is no current proven pharmacological or psychological treatment. This multicentre, randomized, fixed-dose, parallel-group, placebo-controlled study of the reversible inhibitor of monoamine oxidase moclobemide (450 mg/day) and the tricyclic antidepressant imipramine (150 mg/day) evaluated the potential efficacy of active medication, when compared with placebo, in patients with recurrent brief depression, recruited in the mid-1990s. After a 2-4-week single-blind placebo run-in period, a total of 35 patients were randomized to receive double-blind medication for 4 months, but only 16 completed the active treatment period. An intention-to-treat analysis of the 34 evaluable patients found no evidence for the efficacy of moclobemide or imipramine, when compared with placebo, in significantly reducing the severity, duration or frequency of depressive episodes. A total of 28 patients experienced at least one adverse event, and four patients engaged in nonfatal self-harm. Limitations of the study include the small sample size and the high rate of participant withdrawal. The lack of efficacy of these antidepressant drugs and the previous finding of the lack of efficacy of the selective serotonin reuptake inhibitor fluoxetine together indicate that medications other than antidepressant drugs should be investigated as potential treatments for what remains a common, distressing and potentially hazardous condition.

Double-blind, randomized, multicenter study comparing the effect of betahistine and flunarizine on the dizziness handicap in patients with recurrent vestibular vertigo.

PubMed

Albera, Roberto; Ciuffolotti, Roberto; Di Cicco, Maurizio; De Benedittis, Giuseppe; Grazioli, Irene; Melzi, Gabriella; Mira, Eugenio; Pallestrini, Eugenio; Passali, Desiderio; Serra, Agostino; Vicini, Claudio

2003-06-01

The aim of this double-blind, randomized, multicenter study was to compare the efficacy of betahistine dihydrochloride (BH) and flunarizine (FL) using the Dizziness Handicap Inventory (DHI), a validated self-assessment questionnaire that has not previously been used in a clinical trial to evaluate antivertigo drugs. Patients with recurrent vertigo of peripheral vestibular origin and who were severely handicapped by vertigo were randomized to an 8-week course of treatment with oral BH 48 mg daily or oral FL 10 mg daily. The efficacy endpoints were the total DHI score and the physical, functional and emotional subscores. Fifty-two patients completed the study. After 8 weeks of treatment the mean total DHI score and the physical subscore were significantly lower in the BH group compared to the FL group (7.5 and 3.6 points, respectively). The mean total DHI score as well as the three subscores decreased significantly after 4 and 8 weeks in both treatment groups. This study showed that at 8 weeks BH is significantly more effective than FL in terms of improving the total DHI score and the physical subscore. It was also established that the DHI is a useful and reliable method for evaluating the efficacy of antivertigo drugs.

Moclobemide versus fluoxetine in the treatment of major depressive disorder in adults.

PubMed Central

Lapierre, Y D; Joffe, R; McKenna, K; Bland, R; Kennedy, S; Ingram, P; Reesal, R; Rickhi, B G; Beauclair, L; Chouinard, G; Annable, L

1997-01-01

The objective of the present study was to compare the safety and efficacy of moclobemide versus fluoxetine in adult patients with major depressive disorder. The design of the study was a multicenter, double-blind, comparative, and randomized trial. A 1- to 2-week single-blind placebo washout phase was followed by 6 weeks of double-blind treatment with moclobemide or fluoxetine. A total of 150 patients were enrolled in the study. There were 128 patients eligible to be randomized, with 66 patients receiving moclobemide and 62 patients receiving fluoxetine. At the termination of the study, patients in the moclobemide group were receiving a mean dose of 440 mg +/- 123 mg, while the mean dose in the fluoxetine group was 35 mg +/- 8 mg. No significant treatment differences were found for any of the efficacy parameters. Headache and nausea were the most frequently reported adverse events in both treatment groups. Headache and blurred vision were reported significantly more often (P < 0.05) in the fluoxetine group, whereas significantly more dry mouth was reported (P < 0.05) in the moclobemide group. These results provide supporting evidence of the comparable efficacy of moclobemide and fluoxetine and the better tolerability of moclobemide when used in the treatment of major depressive disorder. Images Figure 3 PMID:9074306

A consultation on the optimization of controlled human malaria infection by mosquito bite for evaluation of candidate malaria vaccines.

PubMed

Laurens, Matthew B; Duncan, Christopher J; Epstein, Judith E; Hill, Adrian V; Komisar, Jack L; Lyke, Kirsten E; Ockenhouse, Christian F; Richie, Thomas L; Roestenberg, Meta; Sauerwein, Robert W; Spring, Michele D; Talley, Angela K; Moorthy, Vasee S

2012-08-03

Early clinical investigations of candidate malaria vaccines and antimalarial medications increasingly employ an established model of controlled human malaria infection (CHMI). Study results are used to guide further clinical development of vaccines and antimalarial medications as CHMI results to date are generally predictive of efficacy in malaria-endemic areas. The urgency to rapidly develop an efficacious malaria vaccine has increased demand for efficacy studies that include CHMI and the need for comparability of study results among the different centres conducting CHMI. An initial meeting with the goal to optimize and standardise CHMI procedures was held in 2009 with follow-up meetings in March and June 2010 to harmonise methods used at different centres. The end result is a standardised document for the design and conduct of CHMI and a second document for the microscopy methods used to determine the patency endpoint. These documents will facilitate high accuracy and comparability of CHMI studies and will be revised commensurate with advances in the field. Copyright © 2012. Published by Elsevier Ltd.. All rights reserved.

Working memory and attentional bias on reinforcing efficacy of food.

PubMed

Carr, Katelyn A; Epstein, Leonard H

2017-09-01

Reinforcing efficacy of food, or the relationship between food prices and purchasing, is related to obesity status and energy intake in adults. Determining how to allocate resources for food is a decision making process influenced by executive functions. Attention to appetitive cues, as well as working memory capacity, or the ability to flexibly control attention while mentally retaining information, may be important executive functions involved in food purchasing decisions. In two studies, we examined how attention bias to food and working memory capacity are related to reinforcing efficacy of both high energy-dense and low energy-dense foods. The first study examined 48 women of varying body mass index (BMI) and found that the relationship between attentional processes and reinforcing efficacy was moderated by working memory capacity. Those who avoid food cues and had high working memory capacity had the lowest reinforcing efficacy, as compared to those with low working memory capacity. Study 2 systematically replicated the methods of study 1 with assessment of maintained attention in a sample of 48 overweight/obese adults. Results showed the relationship between maintained attention to food cues and reinforcing efficacy was moderated by working memory capacity. Those with a maintained attention to food and high working memory capacity had higher reinforcing efficacy than low working memory capacity individuals. These studies suggest working memory capacity moderated the relationship between different aspects of attention and food reinforcement. Understanding how decision making process are involved in reinforcing efficacy may help to identify future intervention targets. Copyright © 2017 Elsevier Ltd. All rights reserved.

Efficacy and safety of mepivacaine compared with lidocaine in local anaesthesia in dentistry: a meta-analysis of randomised controlled trials.

PubMed

Su, Naichuan; Liu, Yan; Yang, Xianrui; Shi, Zongdao; Huang, Yi

2014-04-01

The objective of the study was to assess the efficacy and safety of mepivacaine compared with lidocaine used in local anaesthesia in dentistry. Medline, Cochrane Central Register of Controlled Trials, EMBASE, Chinese BioMedical Literature Database, China National Knowledge Infrastructure and WHO International Clinical Trials Registry Platform were searched electronically. Relevant journals and references of studies included were hand-searched for randomised controlled trials comparing mepivacaine with lidocaine in terms of efficacy and safety. Twenty-eight studies were included, of which 15 had low risk of bias and 13 had moderate risk of bias. In comparison with 2% lidocaine with 1:100,000 adrenaline, 3% mepivacaine showed a lower success rate (P = 0.05), a shorter onset time of pulpal anaesthesia (P = 0.0005), inferior pain control during injection phase and superior inhibition of heart rate increase (P < 0.0001). In contrast, 2% mepivacaine with 1:100,000 adrenaline gave a higher success rate (P < 0.00001), a similar onset time of pulpal anaesthesia (P = 0.34) and superior pain control during injection phase (P < 0.0001); 2% mepivacaine with 1:20,000 levonordefrin had the same success rate (P = 0.69) and similar onset time of pulpal anaesthesia (P = 0.90). In addition, 3% mepivacaine had shorter onset time (P = 0.004), same level of success rate (P = 0.28) and similar pain control during injection and postinjection compared with 2% lidocaine with 1:50,000 adrenaline. Given the efficacy and safety of the two solutions, 2% mepivacaine with vasoconstrictors is better than 2% lidocaine with vasoconstrictors in dental treatment. Meanwhile, 3% plain mepivacaine is better for patients with cardiac diseases. © 2014 FDI World Dental Federation.

Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study.

PubMed

Assem, M; Elsabaawy, M; Abdelrashed, M; Elemam, S; Khodeer, S; Hamed, W; Abdelaziz, A; El-Azab, G

2016-03-01

Primary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable. Three hundred thirty-four cirrhotic patients with high SAAG (≥1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or renal impairment (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level <130 mEq/L) were included in an open-label, randomized study aimed at comparing alternating use of norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations. Alternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4% vs. 68.3%, p < 0.048). Pairwise analysis showed that alternating regimen had lower probability to develop SBP when compared to a norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported. Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.

Parental modelling of mathematical affect: self-efficacy and emotional arousal

NASA Astrophysics Data System (ADS)

Bartley, Sarah R.; Ingram, Naomi

2017-12-01

This study explored the relationship between parents' mathematics self-efficacy and emotional arousal to mathematics and their 12- and 13-year-old children's mathematics self-efficacy and emotional arousal to mathematics. Parental modelling of affective relationships during homework was a focus. Eighty-four parent and child pairings from seven schools in New Zealand were examined using embedded design methodology. No significant correlations were found when the parents' mathematics self-efficacy and emotional arousal to mathematics were compared with the children's mathematics self-efficacy and emotional arousal to mathematics. However, the parents' level of emotional arousal to mathematics was found to have affected their willingness to assist with mathematics homework. For those parents who assisted, a significant positive correlation was found between their mathematics self-efficacy and their children's emotional arousal to mathematics. Parents who did assist were generally reported as being calm, and used techniques associated with positive engagement. Fathers were calmer and more likely to express readiness to assist with mathematics homework than mothers. A further significant positive correlation was found between fathers' emotional arousal to mathematics and children's mathematics self-efficacy. Implications from the study suggest directions for future research.

Teaching social-communication skills to preschoolers with autism: efficacy of video versus in vivo modeling in the classroom.

PubMed

Wilson, Kaitlyn P

2013-08-01

Video modeling is a time- and cost-efficient intervention that has been proven effective for children with autism spectrum disorder (ASD); however, the comparative efficacy of this intervention has not been examined in the classroom setting. The present study examines the relative efficacy of video modeling as compared to the more widely-used strategy of in vivo modeling using an alternating treatments design with baseline and replication across four preschool-aged students with ASD. Results offer insight into the heterogeneous treatment response of students with ASD. Additional data reflecting visual attention and social validity were captured to further describe participants' learning preferences and processes, as well as educators' perceptions of the acceptability of each intervention's procedures in the classroom setting.

Antibiotic expected effectiveness and cost under real life microbiology: evaluation of ertapenem and ceftriaxone in the treatment of community-acquired pneumonia for elderly patients in Spain

PubMed Central

Grau, Santiago; Lozano, Virginia; Valladares, Amparo; Cavanillas, Rafael; Xie, Yang; Nocea, Gonzalo

2014-01-01

Background Clinical efficacy of antibiotics may be affected by changes in the susceptibility of microorganisms to antimicrobial agents. The purpose of this study is to assess how these changes could affect the initial efficacy of ertapenem and ceftriaxone in the treatment of community-acquired pneumonia (CAP) in elderly patients and the potential consequences this may have in health care costs. Methods Initial efficacy in elderly was obtained from a combined analysis of two multicenter, randomized studies. An alternative scenario was carried out using initial efficacy data according to the pneumonia severity index (PSI). Country-specific pathogens distribution was obtained from a national epidemiological study, and microbiological susceptibilities to first- and second-line therapies were obtained from Spanish or European surveillance studies. A decision analytic model was used to compare ertapenem versus ceftriaxone for CAP inpatient treatment. Inputs of the model were the expected effectiveness previously estimated and resource use considering a Spanish national health system perspective. Outcomes include difference in proportion of successfully treated patients and difference in total costs between ertapenem and ceftriaxone. The model performed one-way and probabilistic sensitivity analyses. Results First-line treatment of CAP with ertapenem led to a higher proportion of successfully treated patients compared with ceftriaxone in Spain. One-way sensitivity analysis showed that length of stay was the key parameter of the model. Probabilistic sensitivity analysis showed that ertapenem can be a cost-saving strategy compared with ceftriaxone, with a 59% probability of being dominant (lower costs with additional health benefits) for both, elderly patients (>65 years) and patients with PSI >3. Conclusion The incorporation of the current antimicrobial susceptibility into the initial clinical efficacy has a significant impact in outcomes and costs in CAP treatment. The treatment with ertapenem compared with ceftriaxone resulted in better clinical outcomes and lower treatment costs for two segments of the Spanish population: elderly patients and patients with severe pneumonia (PSI >3). PMID:24611019

Boys' and girls' involvement in science learning and their self-efficacy in Taiwan.

PubMed

Hong, Zuway-R; Lin, Huann-shyang

2013-01-01

This cross-sectional study investigated the significant differences in students' self-efficacy and their involvement in learning science. Nine hundred and twenty-two elementary school fifth graders, 499 junior high school eighth graders, and 1455 senior or vocational high school eleventh graders completed the students' questionnaire. Analyses of variance (ANOVAs) and independent t-tests compared the significant similarities and differences across school levels and genders. The initial findings were as follows: A sharp decline in boys' and girls' self-efficacy scores from elementary to secondary school levels; boys have significantly higher self-efficacy scores than girls at vocational and senior high school levels; students with more involvement in science learning presented significantly higher self-efficacy scores than those with less involvement. The significant discrepancies in terms of gender and age in students' self-efficacy and involvement in learning science need to be addressed. Implications and limitations are provided.

Effects of a prevention program for internet addiction among middle school students in South Korea.

PubMed

Yang, Sun-Yi; Kim, Hee-Soon

2018-05-01

This study explored the effects of a self-regulatory efficacy improvement program on self-control, self-efficacy, internet addiction, and time spent on the internet among middle school students in South Korea. The program was led by school nurses, and it is integrated self-efficacy and self-regulation promotion strategies based on Bandura's social cognitive theory. A quasi-experimental, nonequivalent, control group, pre-posttest design was used. The participants were 79 middle school students. Measurements included the Self-Control Scale, Self-Efficacy Scale, Internet Addiction Proneness Scale, and an assessment of internet addiction. Self-control and self-efficacy significantly increased and internet addiction and time spent on the internet significantly decreased in the intervention group compared with the control group. A program led by school nurses that integrated and applied self-efficacy and self-regulation intervention strategies proved effective for prevention of students' internet addiction. © 2018 Wiley Periodicals, Inc.

Can we well assess the relative efficacy and tolerability of a new drug versus others at the time of marketing authorization using mixed treatment comparisons? A detailed illustration with escitalopram.

PubMed

Llorca, Pierre-Michel; Lançon, Christophe; Brignone, Mélanie; Painchault, Caroline; Rive, Benoit; Toumi, Mondher; François, Clément

2015-01-01

To assess the variation of relative efficacy and tolerability of an antidepressant versus others based on both pre-marketing (registration studies) and post-marketing studies versus pre-marketing studies only in patients with major depressive disorder. The relative efficacy and tolerability of antidepressants was assessed by mixed treatment comparisons (MTCs) using data acquired over two time periods: before registration of the reference drug escitalopram (1989-2002) and up to 5 years later (1989-2007). Ranking probability outputs were presented for efficacy, using change from baseline to 8 weeks on Montgomery-Åsberg Depression Rating Scale total score, and tolerability, using withdrawals due to adverse events. The relative efficacy and tolerability of some selected antidepressants, including escitalopram, varied considerably over the two time periods. The improved relative efficacy and tolerability of escitalopram over time, compared with citalopram, was demonstrated by greater separation of ranking probability curves for efficacy and tolerability. In 2002, escitalopram ranked low with 13.9% and 5.1% probability of being in the top four antidepressants' relative efficacy and tolerability, respectively. In 2007, ranking probabilities for relative efficacy and tolerability of escitalopram increased to 52.5% and 82.1%, respectively. Time of marketing authorization may not be the most appropriate time to evaluate the relative efficacy and tolerability of a new antidepressant based on MTC approach due to the asymmetry of information between new and older compounds. However, the first evaluation of relative effect of a new drug for health technology assessment recommendations is commonly done at this time. Re-evaluation of a drug several years after its launch is likely to provide a more accurate indication of its relative efficacy and tolerability.

A comparison of reactivating and therapeutic efficacy of bispyridinium acetylcholinesterase reactivator KR-22934 with the oxime K203 and commonly used oximes (obidoxime, trimedoxime, HI-6) in tabun-poisoned rats and mice.

PubMed

Kassa, Jiri; Karasova, Jana Zdarova; Pavlikova, Ruzena; Musilek, Kamil; Kuca, Kamil; Bajgar, Jiri; Jung, Young-Sik

2011-03-01

The potency of bispyridinium acetylcholinesterase reactivator KR-22934 in reactivating tabun-inhibited acetylcholinesterase and reducing tabun-induced lethal toxic effects was compared with the oxime K203 and commonly used oximes. Studies determining percentage of reactivation of tabun-inhibited blood and tissue acetylcholinesterase in rats showed that the reactivating efficacy of KR-22934 was slightly higher than the reactivating efficacy of K203 and roughly corresponded to the reactivating efficacy of obidoxime and trimedoxime in blood and diaphragm. On the other hand, the oxime KR-22934 was not able to reactivate tabun-inhibited acetylcholinesterase in the brain. The therapeutic efficacy of all oximes studied approximately corresponded to their reactivating efficacy. Based on the results, one can conclude that the oxime KR-22934 is not suitable for the replacement of commonly used oximes for the antidotal treatment of tabun poisoning in spite of its potency to reactivate tabun-inhibited acetylcholinesterase in the peripheral compartment (blood, diaphragm).

A serial mediation model of message framing on intentions to receive the human papillomavirus (HPV) vaccine: revisiting the role of threat and efficacy perceptions.

PubMed

Krieger, Janice L; Sarge, Melanie A

2013-01-01

Previous research has yielded mixed findings regarding the potential for message framing to influence HPV vaccine-related intentions. Drawing on the Extended Parallel Process Model (EPPM), the current study focuses on the role of threat and efficacy as serial mediators linking message framing and HPV vaccine-related intentions. College-age females and their parents participated in a between-subjects, posttest only experiment to investigate whether behavioral intentions to talk to a doctor about the HPV vaccine differ as a function of framing messages in terms of disease prevention. For young women, framing messages as preventing genital warts (as compared to cancer prevention) significantly increased perceptions of self-efficacy, which enhanced response efficacy perceptions that, in turn, increased intentions to talk to a doctor about the HPV vaccine. There were no effects of message framing among parents. However, response efficacy was a significant mediator of self-efficacy and behavioral intentions for both the college-age females and their parents. The results of this study suggest new approaches for considering the relationship among EPPM constructs.

A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain.

PubMed

Furlan, Andrea D; Yazdi, Fatemeh; Tsertsvadze, Alexander; Gross, Anita; Van Tulder, Maurits; Santaguida, Lina; Gagnier, Joel; Ammendolia, Carlo; Dryden, Trish; Doucette, Steve; Skidmore, Becky; Daniel, Raymond; Ostermann, Thomas; Tsouros, Sophia

2012-01-01

Background. Back pain is a common problem and a major cause of disability and health care utilization. Purpose. To evaluate the efficacy, harms, and costs of the most common CAM treatments (acupuncture, massage, spinal manipulation, and mobilization) for neck/low-back pain. Data Sources. Records without language restriction from various databases up to February 2010. Data Extraction. The efficacy outcomes of interest were pain intensity and disability. Data Synthesis. Reports of 147 randomized trials and 5 nonrandomized studies were included. CAM treatments were more effective in reducing pain and disability compared to no treatment, physical therapy (exercise and/or electrotherapy) or usual care immediately or at short-term follow-up. Trials that applied sham-acupuncture tended towards statistically nonsignificant results. In several studies, acupuncture caused bleeding on the site of application, and manipulation and massage caused pain episodes of mild and transient nature. Conclusions. CAM treatments were significantly more efficacious than no treatment, placebo, physical therapy, or usual care in reducing pain immediately or at short-term after treatment. CAM therapies did not significantly reduce disability compared to sham. None of the CAM treatments was shown systematically as superior to one another. More efforts are needed to improve the conduct and reporting of studies of CAM treatments.

The effect of exercise on affective and self-efficacy responses in older and younger women.

PubMed

Barnett, Fiona

2013-01-01

This study examined the self-efficacy and affective responses to an acute exercise bout in sedentary older and younger women to determine whether aging has an effect on affective states. Twenty-five sedentary younger (mean age = 19.9 yrs) and 25 older (mean age = 55.7 yrs) women completed an acute bout of exercise. Affective responses were measured before, during, and immediately following exercise. Self-efficacy responses were measured before and immediately following exercise. Positive engagement, revitalization, tranquility, Felt Arousal and Feeling Scale responses, and self-efficacy were all higher immediately following compared with before or during exercise for both groups of women. In addition, older women experienced higher overall positive engagement and lower physical exhaustion compared with younger women as well as higher tranquility and Feeling Scale responses immediately following exercise. This investigation found that an acute bout of moderate-intensity exercise produced more positive and fewer negative affective states in both younger and older women.

Efficacy of dosing and re-dosing of two oral fixed combinations of indomethacin, prochlorperazine and caffeine compared with oral sumatriptan in the acute treatment of multiple migraine attacks: a double-blind, double-dummy, randomised, parallel group, multicentre study

PubMed Central

Sandrini, G; Cerbo, R; Del Bene, E; Ferrari, A; Genco, S; Grazioli, I; Martelletti, P; Nappi, G; Pinessi, L; Sarchielli, P; Tamburro, P; Uslenghi, C; Zanchin, G

2007-01-01

Aims and methods: In this double-blind, double-dummy, randomised, parallel group, multicentre study, the efficacy of dosing and re-dosing of a fixed combination of indomethacin, prochlorperazine and caffeine (Indoprocaf) was compared with encapsulated sumatriptan in the acute treatment of two migraine attacks. Additionally, in the group taking Indoprocaf, two different oral formulations were tested: effervescent tablets and encapsulated coated tablets. Results: Of 297 patients randomised (150 assigned to Indoprocaf and 147 to sumatriptan), 281 were included in the intention-to-treat efficacy analysis. The initial dosing of Indoprocaf and sumatriptan was similarly effective with pain-free rates higher than 30% (95% CI of odds-ratio: 0.57–1.28) and headache relief rates of about 60% (95% CI of odds-ratio: 0.82–1.84) with both the drugs. The efficacy of re-dosing of Indoprocaf as rescue medication was more effective than that of sumatriptan with pain-free values of 47% vs. 27% in the total attacks with a statistically significant difference in the first migraine attack in favour of Indoprocaf. The efficacy of re-dosing to treat a recurrence/relapse was very high without differences between the drugs (pain-free: 60% with Indoprocaf and 50% with sumatriptan in the total attacks). Indoprocaf and sumatriptan were well-tolerated. Conclusion: The study demonstrated that the efficacy of the initial dosing of Indoprocaf was not higher than that of sumatriptan, but that the strategy to use the lowest effective dose as soon as the headache occurred, followed by a second dose if the headache has not relieved or to treat a relapse, was very effective, especially with Indoprocaf. PMID:17627707

The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study.

PubMed

Hu, Xingsheng; Zhang, Li; Shi, Yuankai; Zhou, Caicun; Liu, Xiaoqing; Wang, Dong; Song, Yong; Li, Qiang; Feng, Jifeng; Qin, Shukui; Xv, Nong; Zhou, Jianying; Zhang, Li; Hu, Chunhong; Zhang, Shucai; Luo, Rongcheng; Wang, Jie; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

2015-01-01

Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125 mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety. From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9-6.6 m) and 5.4 months (95%CI 3.1-7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127). In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy. ClinicalTrials.gov NCT02486354.

The efficacy and integrity of shape memory alloy staples and bone anchors with ligament tethers in the fusionless treatment of experimental scoliosis.

PubMed

Braun, John T; Akyuz, Ephraim; Ogilvie, James W; Bachus, Kent N

2005-09-01

Scoliosis is a complex three-dimensional deformity with limited treatment options. Current treatments present potential problems that may be addressed with use of fusionless techniques for the correction of scoliosis. However, there are few data comparing the efficacy of different fusionless implant strategies in controlling scoliosis or on the integrity of rigid compared with flexible devices in an in vivo setting over time. The objective of this study was to compare the efficacy and integrity of rigid and flexible anterior thoracic tethers used to treat experimental scoliosis. Experimental scoliosis was created in twenty-four Spanish Cross-X female goats and was subsequently treated with either anterior shape memory alloy staples or anterior ligament tethers attached to bone anchors. Serial radiographs were analyzed to determine the efficacy of the implants in controlling scoliosis progression as well as the integrity of the implants at study completion. After the goats were killed, the implants were analyzed with use of three quantitative indices of implant integrity and implant pullout testing. Over the treatment period, scoliosis progressed from 77.3 degrees to 94.3 degrees in the goats treated with staples and was corrected from 73.4 degrees to 69.9 degrees in the goats treated with bone anchors, with loosening of eighteen of forty-two staples (two of the eighteen dislodged) and evidence of drift in two of forty-nine anchors. Histologic sections revealed a consistent halo of fibrous tissue around the staple tines but well-fixed bone anchors at all sites. Pullout testing demonstrated that bone anchors had greater strength than staples initially and at the study completion, with an increase in bone anchor fixation over the course of the study. In this scoliosis model, the flexible ligament tethers attached to bone anchors demonstrated greater efficacy and integrity than the more rigid shape memory alloy staples.

A randomized, double-blind, split-face study comparing the efficacy and tolerability of three retinol-based products vs. three tretinoin-based products in subjects with moderate to severe facial photodamage.

PubMed

Babcock, Michael; Mehta, Rahul C; Makino, Elizabeth T

2015-01-01

Retinol, has been shown to improve the appearance of photodamaged skin when applied topically, and is generally considered to be approximately ten times less potent than tretinoin. To assess this theory, three cosmetic formulations containing 0.25%, 0.5%, and 1.0% retinol were developed to correspond to the three commonly prescribed concentrations of tretinoin (0.025%, 0.05%, and 0.1%). A randomized, double-blind, split-face comparison study was conducted to compare the three concentrations retinol (Ret) including 0.25%, 0.5%, and 1.0%, against the respective three strengths of tretinoin (Tret) 0.025%, 0.05%, and 0.1% in subjects with moderate to severe facial photodamage. Subjects were randomized into three groups: Group 1 (Ret 0.25% vs. Tret 0.025%); Group 2 (Ret 0.5% vs. Tret 0.05%); and Group 3 (Ret 1.0% vs. Tret 0.1%). Within each group, subjects were randomized to apply Ret on one half of the face (left or right) and Tret on the other facial side, for a duration of twelve weeks. Clinical evaluations for efficacy and tolerability, as well as standardized digital photographs were conducted at baseline and at weeks 4, 8, and 12. Sixty-five subjects completed the twelve-week study (Group 1: n=24, Group 2: n=20, and Group 3: n=21). At week 12 in all treatment groups, both Ret and Tret produced statistically significant improvements from baseline in all efficacy parameters, including overall photodamage, fine lines/wrinkles, coarse lines/wrinkles, skin tone brightness, mottled pigmentation, and tactile roughness (all P<0.001). There were no significant differences in efficacy between Ret and Tret in these efficacy parameters. Results from this comparison study suggest that this sustained-release retinol complex containing multiple agents for optimal irritation control provides comparable improvements to tretinoin in the appearance of photodamage.

Antibiotic efficacy in patients with a moderate probability of acute rhinosinusitis: a systematic review.

PubMed

Burgstaller, Jakob M; Steurer, Johann; Holzmann, David; Geiges, Gabriel; Soyka, Michael B

2016-05-01

The aim of this systematic review was to synthesize the results of original studies assessing antibiotic efficacy at different time points after initiating treatment in patients with a moderate probability of acute bacterial rhinosinusitis. We searched the Cochrane library for systematic reviews on the efficacy of antibiotic treatment in patients with acute rhinosinusitis (ARS). Only randomized controlled trials (RCTs) that compared treatment of any antibiotic with placebo were included. The synthesis of the results of six RCTs showed a benefit of antibiotic treatment compared to placebo for the rate of improvement after 3 [pooled odds ratio (OR) 2.78 (95 % confidence interval (CI) 1.39-5.58)] and 7 [OR 2.29 (95 % CI 1.19-4.41)] days after initiation in patients with symptoms and signs of ARS lasting for 7 or more days. After 10 days [pooled OR 1.36 (95 % CI 0.66-2.90)], improvement rates did not differ significantly between patients treated with or without antibiotics. Compared to placebo, antibiotic treatment relieves symptoms in a significantly higher proportion of patients within the first days of treatment. Reporting an overall average treatment efficacy may underestimate treatment benefits in patients with a self-limiting illness.

Comparative efficacy of chloroquine and sulphadoxine--pyrimethamine in pregnant women and children: a meta-analysis.

PubMed

Kalanda, Gertrude C; Hill, Jenny; Verhoeff, Francine H; Brabin, Bernard J

2006-05-01

To compare the efficacy of chloroquine and sulphadoxine-pyremethamine against Plasmodium falciparum infection in pregnant women and in children from the same endemic areas of Africa, with the aim of determining the level of correspondence in efficacy determinations in these two risk groups. Meta-analysis of nine published and unpublished in vivo antimalarial efficacy studies in pregnant women and in children across five African countries. Pregnant women (all gravidae) were more likely to be sensitive than children to both chloroquine (odds ratio: 2.07; 95% confidence interval: 1.5, 2.9) and sulphadoxine-pyrimethamine (odds ratio: 2.66; 95% confidence interval: 11.1, 6.7). Pregnant women demonstrated an almost uniform increased sensitivity for peripheral parasite clearance at day 14 compared with children. This finding was consistent across a wide range of drug sensitivities. Primigravidae at day 14 showed lower clearance to antimalarial drugs than multigravidae (P<0.05). There was no significant difference between parasite clearance in primigravidae and in children. The greater drug sensitivity in pregnant women probably indicates differences in host susceptibility rather than parasite resistance. Parasite sensitivity patterns in children may be a suitable guide to antimalarial policy in pregnant women.

Efficacy, safety, tolerability and price of newly approved drugs in solid tumors.

PubMed

Barnes, Tristan A; Amir, Eitan; Templeton, Arnoud J; Gomez-Garcia, Susana; Navarro, Beatriz; Seruga, Bostjan; Ocana, Alberto

2017-05-01

New anti-cancer drugs utilize diverse mechanisms of action. Here we evaluate their differential efficacy, safety, tolerability and price. Drugs approved for solid tumor treatment between 2000 and 2015 were identified and analyzed in subgroups: agents targeting oncogenes (group 1), anti-angiogenics (group 2), immunotherapy (group 3), and chemotherapy (group 4). Hazard ratios (HRs) were extracted from the registration trials and pooled in a meta-analysis. Odds ratios for toxic death, treatment discontinuation and grade 3-4 toxicity were compared to control groups. The Micromedex Red Book was used to calculate the monthly price. Analysis included 74 studies comprising 48,527 patients. Progression-free survival (PFS) was improved to a greater degree with groups 1 and 2 than with groups 3 and 4, (pooled HR: 0.54, 0.56, 0.63, and 0.76 for groups 1-4 respectively, p for difference <0.001). Compared to PFS, there was a lower magnitude of improvement overall survival in all groups and the degree of benefit was less for group 4 than for other groups (pooled HR: 0.77, 0.78, 0.68, and 0.83 for groups 1-4 respectively, p for difference=0.007). Compared to control groups in individual trials, immunotherapy was associated with better safety and tolerability than other groups. Drug prices have increased over time with no significant difference between groups. There was no meaningful correlation between pricing and efficacy. Compared to control groups, immunotherapeutics and drugs targeting oncogenes or angiogenesis improve efficacy to a greater degree than chemotherapy. Immunotherapy appears to have better safety and tolerability profile compared to other cancer therapies. Market price of drugs is not related to efficacy. Copyright © 2017 Elsevier Ltd. All rights reserved.

Parent Self-Efficacy as an Influencing Factor in Parent Participation in Homework Activities: Perceptions of Head Start Parents and Educators

ERIC Educational Resources Information Center

Olivas, Cynthia

2013-01-01

Purpose: The purpose of the study was to explore the perceptions of parents and educators toward the role parents assumed in supporting preschool children academically, and to assess parents' self-efficacy and its influence on parental involvement in preschoolers' homework tasks. A further purpose was to compare parents' perceived self-efficacy…

An Investigation of Pre-Service Science Teachers' Level of Efficacy in the Undergraduate Science Teacher Education Program and Pedagogical Formation Program

ERIC Educational Resources Information Center

Çetin, Oguz

2017-01-01

The purpose of this research is to comparatively investigate the efficacy levels of pre-service science (Science, Biology, Physics, and Chemistry) teachers enrolled at the Undergraduate Program of Science Teacher Education and Pedagogical Formation Program. A total of 275 pre-service teachers who were studying in different programmes in the…

Virtual Connections, Personal Resources, Loneliness, and Academic Self-Efficacy among College Students with and without LD

ERIC Educational Resources Information Center

Sharabi, Adi; Sade, Sarit; Margalit, Malka

2016-01-01

The goals of the study were first to compare the social and academic well-being (loneliness and academic self-efficacy (ASE) among college students with and without learning disabilities (LD), as well as three personal strengths (hope, optimism and sense of coherence (SOC). The second goal was to identify the predicting factors to their loneliness…

An Examination of the Characteristics Impacting Collaborative Tool Efficacy: The Uncanny Valley of Collaborative Tools

ERIC Educational Resources Information Center

Dishaw, Mark T.; Eierman, Michael A.; Iversen, Jacob H.; Philip, George

2013-01-01

As collaboration among teams that are distributed in time and space is becoming increasingly important, there is a need to understand the efficacy of tools available to support that collaboration. This study employs a combination of the Technology Acceptance Model (TAM) and the Task-Technology Fit (TTF) model to compare four different technologies…

Efficacy of granular deltamethrin against Ixodes scapularis and Amblyomma americanum (Acari: Ixodidade) nymphs.

PubMed

Schulze, T L; Jordan, R A; Hung, R W; Taylor, R C; Markowski, D; Chomsky, M S

2001-03-01

A single barrier application of granular deltamethrin to the woodland edges of a forested residential community in late spring significantly reduced the abundance of Ixodes scapularis Say nymphs. The application also suppressed the population of Amblyomma americanum (L.) nymphs, which recently became established in the study area. The efficacy of deltamethrin is compared with other commonly used acaricides.

Do Graduate Teacher Education Programs Change Teachers' Attitudes toward Inclusion and Efficacy Beliefs?

ERIC Educational Resources Information Center

Tournaki, Nelly; Samuels, W. Ellery

2016-01-01

This study compared changes in attitudes toward inclusion and efficacy of 98 general and 76 special education students completing their master's degree. Data were collected at the beginning of the program, at the end of the first semester--upon completion of an Introduction to Inclusion course--and at the end of the program. Results indicated…

Specificity of Treatment Effects: Cognitive Therapy and Relaxation for Generalized Anxiety and Panic Disorders

ERIC Educational Resources Information Center

Siev, Jedidiah; Chambless, Dianne L.

2007-01-01

The aim of this study was to address claims that among bona fide treatments no one is more efficacious than another by comparing the relative efficacy of cognitive therapy (CT) and relaxation therapy (RT) in the treatment of generalized anxiety disorder (GAD) and panic disorder without agoraphobia (PD). Two fixed-effects meta-analyses were…

How Does Student Ability and Self-Efficacy Affect the Usage of Computer Technology?

ERIC Educational Resources Information Center

Isman, Aytekin; Celikli, Gulsun Ersoy

2009-01-01

The main aim of this research was to find out the self-efficacy level among participant students and analyze their beliefs. This study showed that male students are more confident comparing to female student, similar to research of Bimer (2000), the computer usage has been known as biased toward the interests and fashion of men, this research also…

Linagliptin versus sitagliptin in patients with type 2 diabetes mellitus: a network meta-analysis of randomized clinical trials.

PubMed

Keshavarz, Khosro; Lotfi, Farhad; Sanati, Ehsan; Salesi, Mahmood; Hashemi-Meshkini, Amir; Jafari, Mojtaba; Mojahedian, Mohammad M; Najafi, Behzad; Nikfar, Shekoufeh

2017-10-25

Diabetes is one of the most common chronic and costly diseases worldwide and type 2 diabetes is the most common type which accounts for about 90% of cases with diabetes. New medication-therapy regimens such as those containing linagliptin alone or in combination with other medications (within the category of DDP-4 inhibitors) must be evaluated in terms of efficacy and compared with other currently used drugs and then enter the medication list of the country. Hence, this study aimed to compare the clinical efficacy of the two drugs, i.e. linagliptin and sitagliptin, in patients with type 2 diabetes. A systematic review was conducted to identify all clinical trials published by 2015 which compared the two drugs in patients with type 2 diabetes. Using keywords such as "linagliptin", "type 2 diabetes mellitus", "sitagliptin" and related combinations, we searched databases including Scopus, PubMed, and Web of Science. The quality of the selected studies was evaluated using the Jadad score. Considering primary and secondary outcomes extracted from the reviewed studies, a network meta-analysis was used to conduct a systematic comparison between the two studied drugs. This network meta-analysis included 32 studies (Linagliptin vs PLB: n = 8, Sitagliptin vs PLB: n = 13, Linagliptin + MET vs PLB + MET: n = 4, and Sitagliptin + MET vs PLB + MET: n = 7) and a total of 13,747 patients. The results showed no significant difference between linagliptin and sitagliptin in terms of key efficacy and safety outcomes such as HbA1c changes from baseline, body weight change from baseline, percentage of patients achieving HbA1c <7, and percentage of patients experiencing hypoglycemic events (p > 0.05). The results showed that the efficacy of the two drug regimens was the same. Based on the results, there was no significant difference between the two drugs, i.e. linagliptin and sitagliptin, in terms of efficacy; in other words, the efficacy of the two drugs was the same. Therefore, the use of these two drugs depends on their availability and cost. Graphical abstract of the network meta-analysis performed to evaluate the alternatives under the study.

In vitro and in vivo Efficacy of New Blue Light Emitting Diode Phototherapy Compared to Conventional Halogen Quartz Phototherapy for Neonatal Jaundice

PubMed Central

Chang, Yun Sil; Hwang, Jong Hee; Kwon, Hyuk Nam; Choi, Chang Won; Ko, Sun Young; Park, Won Soon; Shin, Son Moon

2005-01-01

High intensity light emitting diodes (LEDs) are being studied as possible light sources for the phototherapy of neonatal jaundice, as they can emit high intensity light of narrow wavelength band in the blue region of the visible light spectrum corresponding to the spectrum of maximal bilirubin absorption. We developed a prototype blue gallium nitride LED phototherapy unit with high intensity, and compared its efficacy to commercially used halogen quartz phototherapy device by measuring both in vitro and in vivo bilirubin photodegradation. The prototype device with two focused arrays, each with 500 blue LEDs, generated greater irradiance than the conventional device tested. The LED device showed a significantly higher efficacy of bilirubin photodegradation than the conventional phototherapy in both in vitro experiment using microhematocrit tubes (44±7% vs. 35±2%) and in vivo experiment using Gunn rats (30±9% vs. 16±8%). We conclude that high intensity blue LED device was much more effective than conventional phototherapy of both in vitro and in vivo bilirubin photodegradation. Further studies will be necessary to prove its clinical efficacy. PMID:15716604

A comparative study of efficacy of emg bio-feedback and progressive muscular relaxation in tension headache.

PubMed

Gada, M T

1984-04-01

The aim of the present study was to find out efficacy of frontalis EMG Biofeedback therapy, deep muscular relaxation therapy and compare the efficacy of both in cases of tension headache. During two week basal-data recording period all patients were taught deep muscular relaxation by Jacobson's technique. Simultaneously patients were instructed to keep headache diary. Headache diary yielded three different parameters a) number of headache-free days per week, b) peak headache intensity (or each week and c) average daily headache activity score per week. These parameters were used to find out therapeutic efficacy of each treatment. Patients were randomly divided in two groups. EMG Biofeedback group was given frontalis EMG feedback through EMG J 33 muscle trainer of Cyborg Corporation (U.S.A.). Patients in each group were given 20 sessions (two sessions per week); each session lasting 30 minutes. Patients were instructed to practice at least one 30 minute session of relaxation at home. The data were subjected to statistical calculation. The results indicate that frontalis EMG Biofeedback therapy and deep muscle relaxation therapy are significantly effective in cases of tension headache. Both treatments are equally effective. The findings are discussed in relation to Indian situation.

Biological effective dose evaluation in gynaecological brachytherapy: LDR and HDR treatments, dependence on radiobiological parameters, and treatment optimisation.

PubMed

Bianchi, C; Botta, F; Conte, L; Vanoli, P; Cerizza, L

2008-10-01

This study was undertaken to compare the biological efficacy of different high-dose-rate (HDR) and low-dose-rate (LDR) treatments of gynaecological lesions, to identify the causes of possible nonuniformity and to optimise treatment through customised calculation. The study considered 110 patients treated between 2001 and 2006 with external beam radiation therapy and/or brachytherapy with either LDR (afterloader Selectron, (137)Cs) or HDR (afterloader microSelectron Classic, (192)Ir). The treatments were compared in terms of biologically effective dose (BED) to the tumour and to the rectum (linear-quadratic model) by using statistical tests for comparisons between independent samples. The difference between the two treatments was statistically significant in one case only. However, within each technique, we identified considerable nonuniformity in therapeutic efficacy due to differences in fractionation schemes and overall treatment time. To solve this problem, we created a Microsoft Excel spreadsheet allowing calculation of the optimal treatment for each patient: best efficacy (BED(tumour)) without exceeding toxicity threshold (BED(rectum)). The efficacy of a treatment may vary as a result of several factors. Customised radiobiological evaluation is a useful adjunct to clinical evaluation in planning equivalent treatments that satisfy all dosimetric constraints.

Case Study Teaching

ERIC Educational Resources Information Center

Herreid, Clyde Freeman

2011-01-01

This chapter describes the history of case study teaching, types of cases, and experimental data supporting their effectiveness. It also describes a model for comparing the efficacy of the various case study methods. (Contains 1 figure.)

Effects of competition on students' self-efficacy in vicarious learning.

PubMed

Chan, Joanne C Y; Lam, Shui-fong

2008-03-01

Vicarious learning is one of the fundamental sources of self-efficacy that is frequently employed in educational settings. However, little research has investigated the effects of competition on students' writing self-efficacy when they engage in vicarious learning. This study compared the effects of competitive and non-competitive classrooms on students' writing self-efficacy when they engaged in vicarious learning. The participants were 71 grade 7 students in Hong Kong. Using prior writing performance for stratified random sampling, students were assigned either to a competitive or a non-competitive classroom. Students learned how to compose similes and metaphors in Chinese. In the competitive classroom, students' self-efficacy decreased when they engaged in vicarious learning. In the non-competitive classroom, students' self-efficacy did not show a significant change when they engaged in vicarious learning. The findings suggested that when students engaged in vicarious learning in a competitive classroom, their self-efficacy might be threatened. Implications for efforts to design constructive context for vicarious learning are discussed.

Comparable efficacy and safety of various topical formulations of terbinafine in tinea pedis irrespective of the treatment regimen: results of a meta-analysis.

PubMed

Korting, Hans Christian; Kiencke, Peter; Nelles, Sandra; Rychlik, Reinhard

2007-01-01

Terbinafine has been widely used with major success as a topical antifungal therapy for tinea pedis (athlete's foot). Its efficacy and safety have been validated in several clinical trials, which have demonstrated clinical efficacy for the drug after only 1 week of treatment when applied once daily, a reflection of the high fungicidal potency of the drug and its ability to form a depot in the upper skin layer. To improve patients' compliance further, a terbinafine-containing film-forming solution has been developed for single-dose therapy of athlete's foot. This novel formulation delivers terbinafine in high amounts and for a prolonged period of time into the skin, making one-shot treatment feasible. Over the past years there have been a variety of trials evaluating use of topical terbinafine addressing different pharmaceutical formulations, treatment durations, and application frequencies, but a detailed meta-analysis of these trials has not been conducted to date. The present study is the first meta-analytic evaluation of the available data on the efficacy (clinical and mycologic cure rates) and safety (adverse events) of all topical forms of terbinafine for the treatment of tinea pedis. An international, systematic literature search of 12 electronic databases (including MEDLINE, EMBASE, and Cochrane databases) using a pre-specified search strategy was conducted in March 2006. This meta-analysis included only randomized controlled trials in which terbinafine had been used for topical treatment of tinea pedis in comparison with placebo or an active control. Studies of all available topical formulations of terbinafine, frequencies of application, and durations of treatment were included. Of 100 identified articles published between 1990 and 2006, 19 met the criteria for analysis. These 19 studies involved 2899 patients with clinical and mycologic diagnoses of tinea pedis (nine placebo-controlled trials and ten active-controlled trials). Efficacy analysis demonstrated that the mycologic cure rate was significantly superior with terbinafine compared with placebo (relative risk [RR] 3.17; p < 0.001). No significant differences in efficacy were found amongst different formulations of terbinafine, treatment durations, or frequencies of application. Comparable results were obtained with respect to clinical cure rate for terbinafine compared with placebo (RR 2.75; p < 0.001). Comparison of the efficacy of terbinafine versus active control indicated a nonsignificant difference in favor of terbinafine with regard to mycologic cure rate (RR 1.03; p = 0.423) and clinical cure rate (RR 1.09; p = 0.11). The median duration of treatment was also shorter with terbinafine (1 week) compared with active controls (2 weeks). Analysis of the placebo-controlled studies showed that there was no significant difference in the risk of adverse events with terbinafine compared with placebo (RR 1.34; p = 0.34). Likewise, no significant differences in adverse events were found between terbinafine and active controls (RR 1.08; p = 0.72). Terbinafine is very well tolerated in any topical pharmaceutical formulation and also has high efficacy as a cure for tinea pedis, irrespective of type of pharmaceutical formulation, treatment duration, and frequency of application, including the recently established one-shot regimen. In addition, terbinafine has an apparently unique advantage over other antifungal agents with respect to the required duration of treatment for tinea pedis.

Diagnostic Efficacy of Cell Block Immunohistochemistry, Smear Cytology, and Liquid-Based Cytology in Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Lesions: A Single-Institution Experience

PubMed Central

Qin, Shan-yu; Zhou, You; Li, Ping; Jiang, Hai-xing

2014-01-01

Background The diagnostic efficiency of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) cytology varies widely depending on the treatment method of the specimens. The present study aimed to evaluate the diagnostic efficacy of cell block (CB) immunohistochemistry, smear cytology (SC), and liquid-based cytology (LBC) in patients with pancreatic lesions without consulting an on-site cytopathologist. Methods This study prospectively enrolled 72 patients with pancreatic lesions. The EUS-FNA specimens were examined by SC, LBC, and CB immunohistochemistry. The diagnostic efficacy of the 3 methods was then compared. Patients’ final diagnosis was confirmed by surgical resection specimens, diagnostic imaging, and clinical follow-up. Results Our results included 60 malignant and 12 benign pancreatic lesions. The diagnostic sensitivity (90%), negative predictive value (66.7%), and accuracy (91.7%) of CB immunohistochemistry were significantly higher than those of SC (70.0%, 30.0%, and 75.0%, respectively) and LBC (73.3%, 31.6%, and 77.8%, respectively) (all P<0.05). The combination of CB and SC, or CB and LBC, did not significantly increase the efficacy compared to CB immunohistochemistry alone. Conclusion Our findings suggest that in the absence of an on-site cytopathologist, CB immunohistochemistry on EUS-FNA specimens offers a higher diagnostic efficacy in patients with pancreatic lesions than does SC and LBC. PMID:25259861

Efficacy and Safety of Fish Oil in Treatment of Knee Osteoarthritis.

PubMed

Peanpadungrat, Pornrawee

2015-04-01

To study efficacy and safety of fish oil in treatment of knee osteoarthritis. 75 participants had divided into three groups of 25 people to study efficacy results after taking fish oil 1,000 mg and 2,000 mg once a day for 8 weeks. 1,000 mg of fish oil have EPA 400 mg and DHA 200 mg. All participants had complete visual analog scale for measuring knee pain and knee function. They also had measured 100 meters walking velocity and three steps walking time before taking fish oil. Then they had re-measured all parameters again at 8-12 weeks after taking fish oil to compare the results. All parameters had statistically significant better differences in the group of participants who had taken fish oil when compared to the control group. The average score of patient's satisfaction was 9.06 of 10 and also by verbal response of 50 participants; everyone felt good and happy with fish oil. One participant had hematuriafrom silent CA bladder at 10th week but the other 49 participants were safe without any complications from fish oil. Fish oil 1,000-2,000 mg daily supplementation had significant efficacy to improve knee performance and also are safe in mild to moderate stages of knee osteoarthritics patients. However higher dose 2,000 mg of fish oil had not significant higher efficacy than 1,000 mg of fish oil.

Efficacy of tourniquets exposed to the afghanistan combat environment stored in individual first aid kits versus on the exterior of plate carriers.

PubMed

Weppner, Justin; Lang, Michael; Sunday, Robert; Debiasse, Nicholas

2013-03-01

Between February and May 2010, 1st Battalion, 6th Marines reported a 10% (10/92) breakage rate for tourniquets. One theory suggested was that tourniquets were weakened by exposure to the Afghan environment. Our study was designed to compare three groups of Afghanistan-exposed tourniquets to unexposed tourniquets. The three experimental arms were: (1) Afghan-exposed tourniquets worn on the plate carrier, (2) Afghan-exposed tourniquets carried in the Individual First Aid Kit (IFAK) and wrapped in manufacturer plastic wrapping, and (3) Afghan-exposed tourniquets carried in the IFAK with the manufacturer plastic wrapping removed. The outcome measures of this study were efficacy, breakage, and number of turns required to successfully stop the distal pulse. Tourniquets worn on the plate carrier had an efficacy of 57%, which was significantly lower than the control efficacy rate of 95.2%. When compared to the control arm, there were no significant differences in efficacy between the tourniquets stored in the IFAK with or without manufacturing packaging. No control tourniquets or tourniquets stored in IFAKs broke; however, 46 (12%) of the plate carrier-exposed tourniquets did break. No statistically significant differences were found between the four groups with regard to the median number of turns required to stop the distal pulse. Reprint & Copyright © 2013 Association of Military Surgeons of the U.S.

A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan.

PubMed

Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Itamura, Rio; Asami, Yuko; Kuribayashi, Kazuhiko; Imaeda, Takayuki

2016-01-01

The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75-225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery-Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (-10.76; P=0.031), but not in the flexible-dose (-10.37; P=0.106) group compared with placebo (-9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan.

A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan

PubMed Central

Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Asami, Yuko; Kuribayashi, Kazuhiko; Imaeda, Takayuki

2016-01-01

The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75–225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery–Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (−10.76; P=0.031), but not in the flexible-dose (−10.37; P=0.106) group compared with placebo (−9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan. PMID:26513202

The relationship between nature of science understandings and science self-efficacy beliefs of sixth grade students

NASA Astrophysics Data System (ADS)

Parker, Elisabeth Allyn

Bandura (1986) posited that self-efficacy beliefs help determine what individuals do with the knowledge and skills they have and are critical determinants of how well skill and knowledge are acquired. Research has correlated self-efficacy beliefs with academic success and subject interest (Pajares, Britner, & Valiante, 2000). Similar studies report a decreasing interest by students in school science beginning in middle school claiming that they don't enjoy science because the classes are boring and irrelevant to their lives (Basu & Barton, 2007). The hypothesis put forth by researchers is that students need to observe models of how science is done, the nature of science (NOS), so that they connect with the human enterprise of science and thereby raise their self-efficacy (Britner, 2008). This study examined NOS understandings and science self-efficacy of students enrolled in a sixth grade earth science class taught with explicit NOS instruction. The research questions that guided this study were (a) how do students' self-efficacy beliefs change as compared with changes in their nature of science understandings?; and (b) how do changes in students' science self-efficacy beliefs vary with gender and ethnicity segregation? A mixed method design was employed following an embedded experimental model (Creswell & Plano Clark, 2007). As the treatment, five NOS aspects were first taught by the teachers using nonintegrated activities followed by integrated instructional approach (Khishfe, 2008). Students' views of NOS using the Views on Nature of Science (VNOS) (Lederman, Abd-El-Khalick, & Schwartz, 2002) along with their self-efficacy beliefs using three Likert-type science self-efficacy scales (Britner, 2002) were gathered. Changes in NOS understandings were determined by categorizing student responses and then comparing pre- and post-instructional understandings. To determine changes in participants' self-efficacy beliefs as measured by the three subscales, a multivariate analysis of covariance (MANCOVA) was conducted. Findings indicated that explicit NOS instruction was effective for all students except minority (Black, Hispanic, Asian, or multiracial) male students in improving NOS understandings. Furthermore, all students that received NOS instruction demonstrated decreased anxiety towards science. Future research should focus on long-term investigations of changes in anxiety and value of research constructs with regards to NOS instruction.

The efficacy of attentional distraction and sensory monitoring in chronic pain patients: A meta-analysis.

PubMed

Van Ryckeghem, Dimitri Ml; Van Damme, Stefaan; Eccleston, Christopher; Crombez, Geert

2018-02-01

Attentional strategies, such as distraction and sensory monitoring, are often offered to reduce pain and pain-related distress. However, evidence for their efficacy in chronic pain patients is equivocal. We report a meta-analysis on the efficacy of distraction and sensory monitoring in chronic pain patients, and explore possible methodological and theoretical moderators. The scientific literature was searched for relevant articles, which were coded for methodological quality and several theoretical and methodological moderator variables. Only 10 articles fulfilled the search criteria. Eight studies allowed us to compare distraction with a control condition, two studies to compare sensory monitoring with a control condition, and four studies to compare the effect of distraction with the effect of sensory monitoring. Overall, results indicate that distraction did not differ from control in altering pain experience (k=8; Hedges' g=0.10, ns) and distress (k=2; Hedges' g=0.549). Sensory monitoring did also not alter pain experience (k=2; Hedges' g=-0.21, ns) and distress (k=1; Hedges' g=-0.191, ns). We found no evidence to support the superiority of distraction or sensory monitoring in altering pain compared to control conditions. We offer guidance for future theory-driven research to investigate distraction and sensory monitoring in this largely unexplored field, albeit one replete with methodological difficulties. Copyright © 2017 Elsevier Ltd. All rights reserved.

Analgesic efficacy of lysine clonixinate plus tramadol versus tramadol in multiple doses following impacted third molar surgery.

PubMed

Perez-Urizar, J; Martínez-Rider, R; Torres-Roque, I; Garrocho-Rangel, A; Pozos-Guillen, A

2014-03-01

This study compared the analgesic and anti-inflammatory efficacy, trismus control, and tolerability of the combination of lysine clonixinate and tramadol (LCT) versus tramadol (T) alone after surgical removal of impacted mandibular third molars. This study was a double-blind, randomized clinical trial, including two study groups of 20 patients each, who exhibited acute pain subsequent to surgical extraction of two mandibular third molars. Pain intensity was quantified over a 96-h period using a visual analogue scale and a 5-point verbal rating scale. Secondary indicators of analgesic and anti-inflammatory efficacy, trismus control, and tolerability were determined. Patients administered LCT exhibited better therapeutic effects that those administered T. Fifty percent of patients in the LCT group rated this therapy as 'excellent analgesia' compared with only 10% in the T group. The onset of the analgesic effect of LCT was significantly faster, without any therapeutic failures. There were no significant differences between the groups with regard to anti-inflammatory effect or trismus. The results of this study suggest that the postsurgical analgesic efficacy of LCT in combination (LC 125 mg + T 25 mg) is superior to that obtained with T alone, administered at the standard dose of 50 mg, for up to 96 h after the extraction of both impacted mandibular third molars. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

Increased expression of pigment epithelium-derived factor in aged mesenchymal stem cells impairs their therapeutic efficacy for attenuating myocardial infarction injury‡

PubMed Central

Liang, Hongliang; Hou, Huiyuan; Yi, Wei; Yang, Guodong; Gu, Chunhu; Lau, Wayne Bond; Gao, Erhe; Ma, Xinliang; Lu, Zifan; Wei, Xufeng; Pei, Jianming; Yi, Dinghua

2013-01-01

Aims Mesenchymal stem cells (MSCs) can ameliorate myocardial infarction (MI) injury. However, older-donor MSCs seem less efficacious than those from younger donors, and the contributing underlying mechanisms remain unknown. Here, we determine how age-related expression of pigment epithelium-derived factor (PEDF) affects MSC therapeutic efficacy for MI. Methods and results Reverse transcriptase–polymerized chain reaction  and enzyme-linked immunosorbent assay analyses revealed dramatically increased PEDF expression in MSCs from old mice compared to young mice. Morphological and functional experiments demonstrated significantly impaired old MSC therapeutic efficacy compared with young MSCs in treatment of mice subjected to MI. Immunofluorescent staining demonstrated that administration of old MSCs compared with young MSCs resulted in an infarct region containing fewer endothelial cells, vascular smooth muscle cells, and macrophages, but more fibroblasts. Pigment epithelium-derived factor overexpression in young MSCs impaired the beneficial effects against MI injury, and induced cellular profile changes in the infarct region similar to administration of old MSCs. Knocking down PEDF expression in old MSCs improved MSC therapeutic efficacy, and induced a cellular profile similar to young MSCs administration. Studies in vitro showed that PEDF secreted by MSCs regulated the proliferation and migration of cardiac fibroblasts. Conclusions This is the first evidence that paracrine factor PEDF plays critical role in the regulatory effects of MSCs against MI injury. Furthermore, the impaired therapeutic ability of aged MSCs is predominantly caused by increased PEDF secretion. These findings indicate PEDF as a promising novel genetic modification target for improving aged MSC therapeutic efficacy. PMID:21606086

A Comparative Study of Microneedling with Platelet-rich Plasma Plus Topical Minoxidil (5%) and Topical Minoxidil (5%) Alone in Androgenetic Alopecia.

PubMed

Shah, Kaksha B; Shah, Aarti N; Solanki, Rekha B; Raval, Ranjan C

2017-01-01

There are very few studies evaluating efficacy of platelet-rich plasma (PRP) in hair restoration and its combination with microneedling. As far as ascertained, there is no study to evaluate efficacy of microneedling with PRP plus topical minoxidil (5%) versus topical minoxidil (5%) alone in androgenetic alopecia (AGA). This study aims (1) to compare the efficacy of (a) topical minoxidil (5%) alone and (b) topical minoxidil (5%) + microneedling with PRP in men between 18 and 50 years with AGA Grade III to V vertex (Norwood-Hamilton scale) and (2) to perform objective and subjective evaluation based on clinical improvement and photographic evidence. The study was conducted in the outpatient department of dermatology, venereology, and leprology in tertiary care hospital. It was open, prospective study. Fifty patients with AGA were selected on the basis of inclusion and exclusion criteria. These patients were randomly divided into two groups of 25 patients each and were given following treatment: (i) Group A: topical minoxidil (5%) alone and (ii) Group B: topical minoxidil (5%) + microneedling with platelet-rich plasma (PRP). Patients were assessed before starting the treatment and at the end of 6 months on the basis of (a) Patient's self-assessment based on standardized seven-point scale compared with baseline (b) Physician's assessment based on standardized seven-point scale of hair growth compared with baseline. There was a significant improvement ( P < 0.05) in both patients' assessment and investigator's assessment in Group B as compared to Group A at the end of 6 months. Microneedling with PRP is safe, effective, and a promising tool for the management of AGA.

Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates.

PubMed

El-Mashad, Abd El-Rahman; El-Mahdy, Heba; El Amrousy, Doaa; Elgendy, Marwa

2017-02-01

In this prospective study, we compared the efficacy and side effects of indomethacin, ibuprofen, and paracetamol in patent ductus arteriosus (PDA) closure in preterm neonates. Three hundred preterm neonates with hemodynamically significant PDA (hs-PDA) admitted at our neonatal intensive care unit were enrolled in the study. They were randomized into three groups. Group I (paracetamol group) received 15 mg/kg/6 h IV paracetamol infusion for 3 days. Group II (ibuprofen group) received 10 mg/kg IV ibuprofen infusion followed by 5 mg/kg/day for 2 days. Group III (indomethacin group) received 0.2 mg/kg/12 h indomethacin IV infusion for three doses. Laboratory investigations such as renal function test, liver function test, complete blood count, and blood gases were conducted in addition to echocardiographic examinations. All investigations were done before and 3 days after treatment. There was no significant difference between all groups regarding efficacy of PDA closure (P = 0.868). There was a significant increase in serum creatinine levels and serum blood urea nitrogen (BUN) in the ibuprofen and indomethacin groups (P < 0.001). There was a significant reduction in platelet count and urine output (UOP) in both ibuprofen and indomethacin groups (P < 0.001). There was a significant increase in bilirubin levels in only the ibuprofen group (P = 0.003). No significant difference of hemoglobin (HB) level or liver enzymes in all groups (P > 0.05). Ventilatory settings improved significantly in patients with successful closure of PDA than those with failed PDA closure (P < 0.001). Paracetamol is as effective as indomethacin and ibuprofen in closure of PDA in preterm neonates and has less side effects mainly on renal function, platelet count, and GIT bleeding. What is Known: • Hemodynamically significant patent ductus arteriosus has many complications for preterm and low birth weight neonates and better to be closed. Many drugs were used for medical closure of PDA e.g. indomethacin, ibuprofen and recently paracetamol. Many studies compare safety and efficacy of paracetamol with either indomethacin or ibuprofen. What is New: • It is the first large study that compares the efficacy and side effects of the three drugs in one study.

Caseload management, work-related stress and case manager self-efficacy among Victorian mental health case managers.

PubMed

King, Robert

2009-05-01

In Australia and comparable countries, case management has become the dominant process by which public mental health services provide outpatient clinical services to people with severe mental illness. There is recognition that caseload size impacts on service provision and that management of caseloads is an important dimension of overall service management. There has been little empirical investigation, however, of caseload and its management. The present study was undertaken in the context of an industrial agreement in Victoria, Australia that required services to introduce standardized approaches to caseload management. The aims of the present study were therefore to (i) investigate caseload size and approaches to caseload management in Victoria's mental health services; and (ii) determine whether caseload size and/or approach to caseload management is associated with work-related stress or case manager self-efficacy among community mental health professionals employed in Victoria's mental health services. A total of 188 case managers responded to an online cross-sectional survey with both purpose-developed items investigating methods of case allocation and caseload monitoring, and standard measures of work-related stress and case manager personal efficacy. The mean caseload size was 20 per full-time case manager. Both work-related stress scores and case manager personal efficacy scores were broadly comparable with those reported in previous studies. Higher caseloads were associated with higher levels of work-related stress and lower levels of case manager personal efficacy. Active monitoring of caseload was associated with lower scores for work-related stress and higher scores for case manager personal efficacy, regardless of size of caseload. Although caseloads were most frequently monitored by the case manager, there was evidence that monitoring by a supervisor was more beneficial than self-monitoring. Routine monitoring of caseload, especially by a workplace supervisor, may be effective in reducing work-related stress and enhancing case manager personal efficacy.

A survey study comparing young adults with MS and healthy controls on self-esteem, self-efficacy, mood and quality of life.

PubMed

Messmer Uccelli, Michele; Traversa, Silvia; Ponzio, Michela

2016-09-15

Studies have shown that people with multiple sclerosis (MS) report low levels of self-efficacy and self-esteem, high levels of anxiety and depression and reduced quality of life. The study aims to assess self-esteem, self-efficacy, mood and quality of life in young adults with MS and to compare them to a healthy control group. The age range for inclusion in the study was between 18 and 35years of age for both groups. Subjects with MS were recruited through the Italian MS Society. Healthy controls were recruited through social media and from a university undergraduate program. Subjects completed an anonymous online questionnaire combining various scales. Group differences on demographic data were assessed using parametric and non-parametric tests. Analyses of covariance (ANCOVA) were performed to evaluate differences between the two groups on scales of self-perception, mood and quality of life, adjusting for potentially confounding factors. Eighty-nine subjects with MS and 109 HC were included in the analysis. ANCOVA failed to demonstrate statistically significant differences between groups on self-esteem (F=0.11, p=0.743), self-efficacy (F=2.22, p=0.138), mood (anxiety F=0.03, p=0.855; depression F=0.06, p=0.812) and quality of life (F=0.08, p=0.772). This study demonstrated that young adults with MS and healthy controls have similar levels of self-esteem and self-efficacy and that they do not differ significantly on measures of mood and quality of life, as previously reported. Copyright © 2016. Published by Elsevier B.V.

VARIAR Study: Assessment of short-term efficacy and safety of rituximab compared to an tumor necrosis factor alpha antagonists as second-line drug therapy in patients with rheumatoid arthritis refractory to a first tumor necrosis factor alpha antagonist.

PubMed

Torrente-Segarra, Vicenç; Acosta Pereira, Asunción; Morla, Rosa; Ruiz, José Miguel; Clavaguera, Teresa; Figuls, Ramon; Corominas, Hector; Geli, Carme; Roselló, Rosa; de Agustín, Juan José; Alegre, Cayetano; Pérez, Carolina; García, Angel; Rodríguez de la Serna, Arturo

to compare the short-term efficacy and safety of rituximab (RTX) therapy versus anti-TNF in rheumatoid arthritis (RA) patients after discontinuation of a first anti-TNF agent. prospective observational multicenter study in the clinical practice setting, involving patients with severe RA refractory to a first anti-TNF agent, who received either RTX or a second anti-TNF (2TNF), comparing the efficacy endpoints, EULAR response (Good/Moderate) and safety at 6 months. 103 patients enrolled, 82 completed 6-month follow-up, 73.7% women. Baseline data for RTX and 2TNF groups, respectively: TJC, 8.6 and 6.6; SJC, 8.8 and 7.5; DAS28 score, 5.45 (±1.28) and 5.18 (±1.21) (p=0.048), ESR, 41 and 38.7mmHg; and HAQ, 1.2 and 1.0. Improvement was observed in all parameters, with no significant differences (except for a more marked reduction in ESR with RTX). There were no serious adverse events. RTX use as second-line therapy after anti-TNF failure led to improvements in the efficacy and functional variables at 6 months, with no serious adverse events. These results were comparable to those observed in patients who used a second anti-TNF agent in the same clinical scenario. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

Urinary incontinence at orgasm: relation to detrusor overactivity and treatment efficacy.

PubMed

Serati, Maurizio; Salvatore, Stefano; Uccella, Stefano; Cromi, Antonella; Khullar, Vik; Cardozo, Linda; Bolis, Pierfrancesco

2008-10-01

To understand the pathophysiological mechanism of incontinence during orgasm and to compare women affected by symptomatic detrusor overactivity (DO) with and without incontinence at orgasm in terms of efficacy of antimuscarinic treatment. All consecutive sexually active women with incontinence during intercourse were prospectively included and divided into two groups: women with coital incontinence at orgasm or at penetration. The two forms of coital incontinence were correlated to the urodynamic finding of DO. Women complaining of overactive bladder (OAB) symptoms, with urinary incontinence at orgasm and urodynamically proven DO (cases), were prescribed tolterodine 4 mg extended release for at least 12 wk. The cases were compared in terms of efficacy of treatment on OAB symptoms to consecutive patients with symptomatic DO without coital incontinence (control group). Among the 1133 women who underwent urodynamic testings during the study period, 132 patients were eligible for final analysis. A significant difference in DO was observed in women with incontinence at orgasm (34 of 49; 69.4%) compared with women with incontinence during penetration (24 of 83; 28.9%) (p<0.0001). The 34 women with incontinence at orgasm associated with DO were given antimuscarinics treatment and were compared with 53 controls. Fourteen of 34 (41.2%) and 9 of 53 (17%) women did not respond to antimuscarinics in the cases and in the control group, respectively (p=0.023). Incontinence at orgasm is associated with DO in the majority of cases. This is the first study showing an inferior efficacy of antimuscarinic treatment in women with DO complaining of incontinence at orgasm.

Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial.

PubMed

Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

2014-12-01

Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

PubMed Central

Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

2014-01-01

Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care. PMID:25709653

Self-efficacy toward physical activity and the physical activity behavior of children with and without Developmental Coordination Disorder.

PubMed

Batey, C A; Missiuna, C A; Timmons, B W; Hay, J A; Faught, B E; Cairney, J

2014-08-01

Affecting 5-6% of children, Developmental Coordination Disorder (DCD) is a prevalent chronic condition. The nature of the disorder - impaired motor coordination - makes avoidance of physical activity (PA) common. The purpose of this study was to examine the effect of barrier and task self-efficacy on PA behavior in children with DCD and a group of typically developing (TD) children. Children were compared on their perceived ability to complete different intensities and duration of PA (task efficacy) and their confidence in completing PA when faced with everyday barriers (barrier efficacy). An accelerometer was used to record their activity over the subsequent week. Children with DCD were found to have significantly lower task efficacy and barrier efficacy. They also spent significantly less time in moderate to vigorous physical activity (MVPA). Multivariate analyses revealed that gender modified the relationship for both groups. Separate multivariate regressions, were therefore conducted by gender. A direct effect of DCD on PA was observed for boys, but not for girls. Further analyses showed that neither task efficacy nor barrier efficacy influenced the relationship between DCD and PA. Results from this study confirm that children with DCD have lower task and barrier self-efficacy than TD children and that males have lower PA levels than their TD peers; however neither task or barrier self-efficacy mediated the relationship between DCD and PA. Copyright © 2013. Published by Elsevier B.V.

Entertainment-Education Narrative Versus Nonnarrative Interventions to Educate and Motivate Latinas to Engage in Mammography Screening.

PubMed

Borrayo, Evelinn A; Rosales, Monica; Gonzalez, Patricia

2017-06-01

The evidence is limited comparing the effects of entertainment-education (E-E) narrative versus nonnarrative interventions to educate and motivate Latinas to engage in mammography screening. This study compared an E-E narrative intervention to two nonnarrative interventions' effects among Latinas on breast cancer knowledge and motivation, as measured by changes in self-efficacy, behavioral norms, and behavioral intentions to engage in mammography screening. A sample of 141 Spanish-speaking Latinas was randomly assigned to one of three arms: an E-E narrative video, a nonnarrative educational video, and printed educational materials. Using a repeated measures design, the influence of the E-E narrative on pretest to posttest measures was assessed and compared to the influence of the other two interventions. The E-E narrative and nonnarrative interventions significantly increased Latinas' breast cancer knowledge, mammography self-efficacy, and behavioral norms from pretest to posttest. However, the E-E narrative participants' pretest to posttest difference in mammography self-efficacy was significantly higher when compared to the difference of the other two interventions. The effect of the E-E narrative intervention on self-efficacy and behavioral norms was moderated by the participants' absorption in the story and identification with the story characters. E-E narrative and nonnarrative interventions significantly educated and motivated Latinas to engage in mammography screening. The effects on mammography self-efficacy, an important precursor to behavior change, can be more strongly influenced by E-E narratives. Although E-E narrative and nonnarrative interventions were effective, the need still exists to assess if they can ultimately influence lifesaving breast cancer screening behaviors.

Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis

PubMed Central

Takeuchi, Tsutomu; Yamanaka, Hisashi; Tanaka, Yoshiya; Sakurai, Takeo; Saito, Kazuyoshi; Ohtsubo, Hideo; Lee, Sang Joon; Nambu, Yoshihiro

2015-01-01

Objectives. To demonstrate the pharmacokinetic equivalence of CT-P13 and its innovator infliximab (IFX) in Japanese patients with rheumatoid arthritis (RA), and to compare the efficacy and safety of these drugs, administered for 54 weeks. Methods. In a randomized, double-blind, parallel-group, multicenter study, 3 mg/kg of CT-P13 or IFX, in combination with methotrexate (MTX) (6–16 mg/week), was administered for 54 weeks to Japanese active RA patients with an inadequate response to MTX, to demonstrate the pharmacokinetic equivalence, based on the area under the curve (AUCτ) (weeks 6–14) and Cmax (week 6) of these drugs, and to compare their efficacy and safety. Results. The CT-P13-to-IFX ratios (90% confidence intervals) of the geometric mean AUCτ and Cmax values in patients negative for antibodies to infliximab at week 14 were 111.62% (100.24–124.29%) and 104.09% (92.12–117.61%), respectively, demonstrating the pharmacokinetic equivalence of these drugs. In the full analysis set, CT-P13 and IFX showed comparable therapeutic effectiveness, as measured by the American College of Rheumatology, Disease Activity Score in 28 joints, the European League Against Rheumatism, and other efficacy criteria, at weeks 14 and 30. The incidence of adverse events was similar for these drugs. Conclusion. CT-P13 and IFX, administered at a dose of 3 mg/kg in combination with MTX to active RA patients, were pharmacokinetically equivalent and comparable in efficacy and safety. PMID:25736355

The antimicrobial efficacy and structure activity relationship of novel carbohydrate fatty acid derivatives against Listeria spp. and food spoilage microorganisms.

PubMed

Nobmann, Patricia; Smith, Aoife; Dunne, Julie; Henehan, Gary; Bourke, Paula

2009-01-15

Novel mono-substituted carbohydrate fatty acid (CFA) esters and ethers were investigated for their antibacterial activity against a range of pathogenic and spoilage bacteria focussing on Listeria monocytogenes. Carbohydrate derivatives with structural differences enable comparative studies on the structure/activity relationship for antimicrobial efficacy and mechanism of action. The antimicrobial efficacy of the synthesized compounds was compared with commercially available compounds such as monolaurin and monocaprylin, as well as the pure free fatty acids, lauric acid and caprylic acid, which have proven antimicrobial activity. Compound efficacy was compared using an absorbance based broth microdilution assay to determine the minimum inhibitory concentration (MIC), increase in lag phase and decrease in maximum growth rate. Among the carbohydrate derivatives synthesized, lauric ether of methyl alpha-d-glucopyranoside and lauric ester of methyl alpha-d-mannopyranoside showed the highest growth-inhibitory effect with MIC values of 0.04 mM, comparable to monolaurin. CFA derivatives were generally more active against Gram positive bacteria than Gram negative bacteria. The analysis of both ester and ether fatty acid derivatives of the same carbohydrate, in tandem with alpha and beta configuration of the carbohydrate moiety suggest that the carbohydrate moiety is involved in the antimicrobial activity of the fatty acid derivatives and that the nature of the bond also has a significant effect on efficacy, which requires further investigation. This class of CFA derivatives has great potential for developing antibacterial agents relevant to the food industry, particularly for control of Listeria or other Gram-positive pathogens.

Titanium-nitride-oxide-coated coronary stents: insights from the available evidence.

PubMed

Karjalainen, Pasi P; Nammas, Wail

2017-06-01

Coating of stent surface with a biocompatible material is suggested to improve stent safety profile. A proprietary process was developed to coat titanium-nitride-oxide on the stent surface, based on plasma technology that uses the nano-synthesis of gas and metal. Preclinical in vitro and in vivo investigation confirmed blood compatibility of titanium (nitride-) oxide films. Titanium-nitride-oxide-coated stents demonstrated a better angiographic outcome, compared with bare-metal stents at mid-term follow-up; however, they failed to achieve non-inferiority for angiographic outcome versus second-generation drug-eluting stents. Observational studies showed adequate clinical outcome at mid-term follow-up. Non-randomized studies showed an outcome of titanium-nitride-oxide-coated stents comparable to - or better than - first-generation drug-eluting stents at long-term follow-up. Two randomized controlled trials demonstrated comparable efficacy outcome, and a better safety outcome of titanium-nitride-oxide-coated stents versus drug-eluting stents at long-term follow-up. Evaluation by optical coherence tomography at mid-term follow-up revealed better neointimal strut coverage associated with titanium-nitride-oxide-coated stents versus drug-eluting stents; yet, neointimal hyperplasia thickness was greater. Key messages Stents coated with titanium-nitride-oxide demonstrated biocompatibility in preclinical studies: they inhibit platelet and fibrin deposition, and reduce neointimal growth. In observational and non-randomized studies, titanium-nitride-oxide-coated stents were associated with adequate safety and efficacy outcome. In randomized trials of patients with acute coronary syndrome, titanium-nitride-oxide-coated stents were associated with a better safety outcome, compared with drug-eluting stents; efficacy outcome was comparable.

The moderating effect of self-efficacy on normal-weight, overweight, and obese children's math achievement: a longitudinal analysis.

PubMed

Kranjac, Ashley Wendell

2015-03-01

Increased body weight is associated with decreased cognitive function in school-aged children. The role of self-efficacy in shaping the connection between children's educational achievement and obesity-related comorbidities has not been examined to date. Evidence of the predictive ability of self-efficacy in children is demonstrated in cognitive tasks, including math achievement scores. This study examined the relationship between self-efficacy and math achievement in normal weight, overweight, and obese children. I hypothesized that overweight and obese children with higher self-efficacy will be less affected in math achievement than otherwise comparable children with lower self-efficacy. I tested this prediction with multilevel growth modeling techniques using the ECLS-K 1998-1999 survey data, a nationally representative sample of children. Increased self-efficacy moderates the link between body weight and children's math achievement by buffering the risks that increased weight status poses to children's cognitive function. My findings indicate that self-efficacy moderates math outcomes in overweight, but not obese, children. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effects of a simulated emergency airway management education program on the self-efficacy and clinical performance of intensive care unit nurses.

PubMed

Han, Myong-Ja; Lee, Ju-Ry; Shin, Yu-Jung; Son, Jeong-Suk; Choi, Eun-Joo; Oh, Yun-Hee; Lee, Soon-Haeng; Choi, Hye-Ran

2017-12-21

To examine the effects of a simulated emergency airway management education program on the self-efficacy and clinical performance among nurses in intensive care units. A one-group, pre- and post-test design was used. Thirty-five nurses who were working in adult intensive care units participated in this study. The simulation education program included lectures, skill demonstration, skill training, team-based practice, and debriefing. Self-efficacy and clinical performance questionnaires were completed before the program and 1 week after its completion. The data were analyzed by using descriptive statistics and the paired t-test to compare the mean differences between the pre-test and post-test. The scores before and after education were compared. After education, there was a significant improvement in the nurses' self-efficacy and clinical performance in emergency airway management situations. Simulation education effectively improved the self-efficacy and clinical performance of the nurses who were working in intensive care units. Based on the program for clinical nurses within a hospital, it will provide information that might advance clinical nursing education. © 2017 Japan Academy of Nursing Science.

[Asthenic disorders in children].

PubMed

Chutko, L S; Surushkina, S Iu; Nikishena, I S; Iakovenko, E A; Anisimova, T I; Kuzovenkova, M P

2010-01-01

The present study comprised two parts. In the first part, authors attempted to work out the systematics of asthenic disorders based on our own observations of 189 children aged 7-14 years. The following clinical variants of asthenic states in children were singled out: cerebrogenic asthenia (14.3%), somatogenic (13.8%), residual (16.4%), dysontogenetic (20.1%) and neurasthenia (35.4%). In the second part, we summarized the results of treatment of neurasthenia with adaptol (32 patients) compared to pantoham (30 patients). The efficacy of adaptol was higher: the improvement was seen in 71.9% of cases compared to pantoham (56.7%). The good tolerability of adaptol which clinical efficacy is confirmed by neurophysiological and psychological studies is discussed.

Comparative efficacy of selegiline versus rasagiline in the treatment of early Parkinson's disease.

PubMed

Marconi, S; Zwingers, T

2014-07-01

The monoamine oxidase B inhibitors selegiline and rasagiline have not been compared in head-to-head clinical trials in patients with early Parkinson's disease.  The aim of this review was to compare the efficacy of these two agents in this setting. Randomized, placebo-controlled trials with an endpoint of the mean change from baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) total score were included. Analysis included calculation of the standardized mean differences (SMDs) with 95% confidence intervals (CIs) and Forest Plot analyses for comparisons of pooled results. Five studies with selegiline (n = 1029) and four with rasagiline (n = 820) were included. Treatment duration was 2.5-9 months. Both selegiline and rasagiline showed significant SMDs versus placebo (-0.690, 95% CI -0.811, -0.569 and -1.025, 95% CI -1.230, -0.820; respectively), indicating a significant effect of both drugs on UPDRS. The SMD between selegiline and rasagiline was not significantly different (SMD 0.079; 95% CI -0.010, +0.167). It appears that selegiline and rasagiline have comparable efficacy in improving Parkinsonian symptoms in patients with early stage disease.

The Tolerability and Efficacy of Oral Isotonic Solution versus Plain Water in Dengue Patients: A Randomized Clinical Trial.

PubMed

Nainggolan, Leonard; Bardosono, Saptawati; Ibrahim Ilyas, Ermita I

2018-01-01

Plasma leakage plays an important role in dengue infection, and this condition can lead to hemoconcentration, hypovolemia, and shock. Fluid replacement is the main treatment for dengue. There is a lack of evidence to support certain oral fluid therapy as a treatment for dengue patients. The objective of this study is to evaluate tolerability and efficacy of oral isotonic solution (OIS) compared to plain water as a fluid replacement in dengue patients. A randomized, clinical trial with single-blinded groups was conducted to compare tolerability and efficacy of OIS and plain water in dengue patients. We evaluated gastrointestinal disturbances (nausea, vomiting, and bloating), body temperature, mean arterial pressure (MAP), fluid balance, hematocrit, Na + , and K + levels. Data were analyzed with SPSS 20.0, and figures were made with GraphPad Prism version 5.01. Twenty four subjects were included and divided equally into two groups. Our results showed that there are no significant differences but indicate several noteworthy trends. The intervention group (OIS) experienced less nausea, less vomiting, had positive fluid balance and higher MAP, and became afebrile faster compared to the control group (plain water). Although not statistically significant, this study shows the trend that OIS is well-tolerated and effective for dengue patients compared to plain water.

The Comparative Efficacy of Lifestyle Intervention and Metformin by Educational Attainment in the Diabetes Prevention Program

PubMed Central

O’Brien, Matthew J.; Whitaker, Robert C.; Yu, Daohai; Ackermann, Ronald T.

2015-01-01

Objective Educational attainment is inversely associated with type 2 diabetes risk, but it is unknown whether education impacts individuals’ diabetes prevention efforts. We examined the comparative efficacy of intensive lifestyle intervention and metformin by educational attainment among participants in the Diabetes Prevention Program (DPP), an ongoing U.S. multi-site trial beginning in 1996. Methods We studied 2,910 DPP participants randomized to receive lifestyle intervention, metformin, or placebo. Stratifying by educational attainment, diabetes incidence and relative risk reductions by treatment assignment were estimated using Cox proportional hazards regression. Results 47% of participants had completed college and 53% had not. Compared to placebo, lifestyle participants who had completed college demonstrated a 68% reduction in diabetes incidence (95% CI=56, 77), whereas those with less education experienced a 47% risk reduction (95% CI=29, 61). For metformin participants, college graduates experienced a 49% relative risk reduction (95% CI=33, 62), compared to 23% (95% CI=1, 41) among those with lower educational attainment. There was a statistically significant education-by-treatment interaction with incident diabetes (p=0.03). Conclusions Intensive lifestyle intervention and metformin have greater efficacy among highly educated individuals. Future efforts to deliver these treatments and study their dissemination may be more effective if tailored to individuals’ educational background. PMID:26024851

The comparative efficacy of lifestyle intervention and metformin by educational attainment in the Diabetes Prevention Program.

PubMed

O'Brien, Matthew J; Whitaker, Robert C; Yu, Daohai; Ackermann, Ronald T

2015-08-01

Educational attainment is inversely associated with type 2 diabetes risk, but it is unknown whether education impacts individuals' diabetes prevention efforts. We examined the comparative efficacy of intensive lifestyle intervention and metformin by educational attainment among participants in the Diabetes Prevention Program (DPP), an ongoing U.S. multi-site trial beginning in 1996. We studied 2,910 DPP participants randomized to receive lifestyle intervention, metformin, or placebo. Stratifying by educational attainment, diabetes incidence and relative risk reductions by treatment assignment were estimated using Cox proportional hazards regression. 47% of participants had completed college and 53% had not. Compared to placebo, lifestyle participants who had completed college demonstrated a 68% reduction in diabetes incidence (95% CI=56, 77), whereas those with less education experienced a 47% risk reduction (95% CI=29, 61). For metformin participants, college graduates experienced a 49% relative risk reduction (95% CI=33, 62), compared to 23% (95% CI=1, 41) among those with lower educational attainment. There was a statistically significant education-by-treatment interaction with incident diabetes (p=0.03). Intensive lifestyle intervention and metformin have greater efficacy among highly educated individuals. Future efforts to deliver these treatments and study their dissemination may be more effective if tailored to individuals' educational background. Copyright © 2015 Elsevier Inc. All rights reserved.

Comparative study of the clinical efficacy of the selective cyclooxygenase-2 inhibitor celecoxib compared with loxoprofen in patients with frozen shoulder.

PubMed

Ohta, Satoru; Komai, Osamu; Hanakawa, Hiroyoshi

2014-01-01

This is a randomized comparative study of the efficacy of celecoxib and loxoprofen in patients with frozen shoulder (scapulohumeral periarthritis). Patients with frozen shoulder who presented with pain as the symptom were divided at random into a celecoxib treatment group (100 mg/dose, twice daily; n = 37) and a loxoprofen treatment group (60 mg/dose, 3 times daily; n = 33). Medication was continued for 1-2 weeks in each group. Each patient was asked to rate the pain on a visual analog scale (score 0-5). This score significantly improved (indicating marked alleviation of pain) in both the celecoxib group (from 3.41 ± 0.86 before treatment to 2.30 ± 1.02 after treatment) and the loxoprofen group (from 3.73 ± 0.67 before treatment to 2.76 ± 0.96 after treatment). In the analysis of disappearance of pain, the percentage of patients showing disappearance of nocturnal pain was significantly higher in the celecoxib group (71.4 %) than in the loxoprofen group (36.8 %). The results confirm that celecoxib is comparable to loxoprofen in terms of analgesic efficacy in patients with frozen shoulder. Among other findings, we report that celecoxib was more effective for nocturnal pain than loxoprofen.

The Treatment of Scabies.

PubMed

Dressler, Corinna; Rosumeck, Stefanie; Sunderkötter, Cord; Werner, Ricardo Niklas; Nast, Alexander

2016-11-14

Scabies is a contagious infestation transmitted by skin-to-skin contact and sometimes by contact with contaminated material. The scabies mite burrows into the skin, producing a papular rash and severe itch at typical sites of predilection. We systematically reviewed the literature to compare the efficacy of various anti-scabies agents, including a calculation of relative risks and confidence intervals. A literature search yielded 596 initial hits; after screening in accor-dance with the defined inclusion and exclusion criteria, 16 studies were selected for this review. Among topical treatments for scabies, permethrin was equally effective or more effective than crotamiton or benzyl benzoate. In a comparison of topical versus systemic treatment, topical permethrin and systemic ivermectin did not differ substantially in efficacy (7 comparative studies revealed no difference; one revealed a difference in favor of permethrin). Comparative trials of topical benzyl benzoate versus systemic ivermectin yielded inconsistent findings. Single and double administrations of ivermectin were similarly effective. In trials involving entire populations with a high prevalence of scabies, systemic ivermectin was found to be superior to topical permethrin. There are hardly any differences in efficacy between the available treatments for scabies. Single administrations of permethrin 5%, crotamiton 10%, and systemic ivermectin are all comparably effective. There are differences in the frequeny and ease of application as well as when eradicating scabies in populations with a high prevalence.

A comparative study to evaluate efficacy, safety and cost-effectiveness between Whitfield's ointment + oral fluconazole versus topical 1% butenafine in tinea infections of skin

PubMed Central

Thaker, Saket J.; Mehta, Dimple S.; Shah, Hiral A.; Dave, Jayendra N.; Kikani, Kunjan M.

2013-01-01

Aims and Objectives: The aim of this study is to compare the efficacy, safety and cost-effectiveness of topical Whitfield's ointment plus oral fluconazole with topical 1% butenafine in tinea infections of the skin. Materials and Methods: Patients were randomly allocated to the two treatment groups and advised to apply either agent topically twice-a-day for 4 weeks on the lesions and fluconazole (150 mg) was administered once a week for 4 weeks in the study group applying Whitfield's ointment. Patients were followed-up at an interval of 10 days for clinical score and global evaluation response was assessed at baseline and during each follow-up. Results: Out of 120 patients enrolled in the study 103 completed the study. Patients treated with Whitfield's ointment and oral fluconazole reduced mean sign and symptom score from 8.81 ± 0.82 to 0.18 ± 0.59 while butenafine treated patients reduced it from 8.88 ± 0.53 to 0.31 ± 0.67 at the end of the treatment. Nearly, 98% patients were completely cleared of the lesion on the 3rd follow-up with both treatments. Conclusion: Whitfield's ointment with oral fluconazole is as efficacious, safe and cost-effective as compared with 1% butenafine in tinea infections of the skin. PMID:24347774

A double-blind, randomized, placebo/active controlled crossover evaluation of the efficacy and safety of Ritalin ® LA in children with attention-deficit/hyperactivity disorder in a laboratory classroom setting.

PubMed

Schulz, Eberhard; Fleischhaker, Christian; Hennighausen, Klaus; Heiser, Philip; Oehler, Klaus-Uwe; Linder, Martin; Haessler, Frank; Huss, Michael; Warnke, Andreas; Schmidt, Martin; Schulte-Markworth, Michael; Sieder, Christian; Klatt, Jan; Tracik, Ferenc

2010-10-01

The primary objective of this study was to demonstrate efficacy of Ritalin(®) LA 20 mg by showing superiority to placebo and noninferiority to Medikinet(®) Retard in a laboratory classroom setting. Secondary objectives included safety/tolerability and further efficacy parameters. A total of 147 children with attention-deficit/hyperactivity disorder (ADHD) diagnosed by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) and aged 6-14 (81% males) and known to be methylphenidate (MPH) responders were enrolled in this multicenter, double-blind, randomized, placebo/active-controlled, three-period (7 days each) crossover study. The Swanson, Kotlin, Agler, M-Flynn, and Pelham (SKAMP) scale was used for efficacy ratings. The mean of SKAMP Combined ratings performed at 10:30 a.m., at 12:00 a.m., and at 1:30 p.m. was defined as the primary parameter. In all, 146 patients completed all treatment periods. Intensity and frequency of adverse events were comparable between the two formulations. Ritalin(®) LA demonstrated superiority compared to placebo (p<0.0001). The observed difference in the SKAMP scores between Ritalin(®) LA and Medikinet(®) Retard between the hours 1.5 until 4.5 did not exceed the noninferiority margin (p=0.0003); therefore, the difference is regarded as not clinically relevant. Similar results were obtained for the secondary efficacy variables. Ritalin(®) LA is an efficacious, well-tolerated treatment option for children aged 6-14 with ADHD.

Indirect comparison of the antiviral efficacy of peginterferon alpha 2a plus ribavirin used with or without simeprevir in genotype 4 hepatitis C virus infection, where common comparator study arms are lacking: a special application of the matching adjusted indirect comparison methodology.

PubMed

Van Sanden, Suzy; Pisini, Marta; Duchesne, Inge; Mehnert, Angelika; Belsey, Jonathan

2016-01-01

The need to assess relative efficacy in the absence of comparative clinical trials is a problem that is often encountered in economic modeling. The use of matching adjusted indirect comparison (MAIC) in this situation has been suggested. We present the results of a MAIC used to evaluate the incremental benefit offered by adding simeprevir (SMV) to standard therapy in the treatment of patients infected with genotype 4 hepatitis C virus (HCV). Individual patient data for a single arm study evaluating the use of SMV with peginterferon alfa 2a + ribavirin (PR) in genotype 4 HCV were available (RESTORE study). A systematic literature review was used to identify studies of PR alone used in the same patient group. By applying the inclusion criteria for each study in turn to the RESTORE dataset and then applying the published MAIC covariate matching algorithm, a series of pseudosamples from RESTORE were generated. After assessment of the matching outcomes, the best matched comparisons were used to derive estimates of efficacy for SMV + PR in patients equivalent to those participating in the PR trial. Five potential comparator studies were identified. After applying the matching process, two emerged as offering the greatest equivalence with the generated RESTORE pseudosamples and were used to estimate SMV + PR efficacy, expressed as the percentage of patients achieving sustained viral response (SVR). In one comparison, SVR in the SMV + PR group was 85% versus 63% for PR alone. In the second comparison, the corresponding SVRs were 77% and 44% respectively. After matching for varying baseline characteristics, both comparisons of RESTORE versus studies of PR alone yielded a benefit for SMV + PR vs PR alone in genotype 4 HCV-infected patients. The incremental gain in SVR associated with use of SMV ranged from 22% to 33%. In the absence of direct comparative studies, the MAIC gives a better perspective than simple comparison of absolute SVR from individual studies.

Comparison of efficacy between buprenorphine and tramadol in the detoxification of opioid (heroin)-dependent subjects.

PubMed

Chawla, Jatinder Mohan; Pal, Hemraj; Lal, Rakesh; Jain, Raka; Schooler, Nina; Balhara, Yatan Pal Singh

2013-01-01

Tramadol is a synthetic opiate and a centrally acting weak m-opioid receptor agonist. The potential advantages of tramadol include ease of administration, low abuse potential, and being nonscheduled. This study compared tramadol and buprenorphine for controlling withdrawal symptoms in patients with opioid dependence syndrome. Consenting male subjects between 20 and 45 years of age who fulfilled the ICD-10-DCR criteria for opiate dependence syndrome were randomly assigned in a double-blind, double-dummy placebo-controlled trial for detoxification. Those with multiple drug dependence, abnormal cardiac, renal and hepatic functions, psychosis, or organic mental illness were excluded. Assessments included Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), Visual Analog Scale (VAS), and Side Effect Check List. Subjects were evaluated daily and study duration was 10 days. Sixty two subjects were enrolled. The mean SOWS and OOWS and VAS were significantly lower in the buprenorphine group on second and third day of detoxification as compared to the tramadol group. Although the retention rate was higher for buprenorphine group throughout the study, when compared with tramadol the difference was not significant on any day. Three subjects in the tramadol group had seizures. Tramadol was found to have limited detoxification efficacy in moderate to severe opioid withdrawal and substantial risk of seizures as compared to buprenorphine. Further studies are warranted to examine its efficacy in mild opioid withdrawal symptoms and its potential use in outpatient settings where its administration advantages may be valuable.

Treatment Efficacy of Multiple Family Therapy for Chinese Families of Children with Attention Deficit Hyperactivity Disorder.

PubMed

Ma, Joyce L C; Lai, Kelly Y C; Xia, Lily Li Li

2018-06-01

The treatment efficacy of multiple family therapy (MFT) for Chinese families of children with attention deficit hyperactivity disorder (ADHD) has not been studied in the past. In this paper, the effect of MFT on different aspects of the lives of the parents in the experimental group (n = 61) was compared with the effect of only the psychoeducational talks on parents in the control group (n = 53). The results of a MANOVA have shown that by the time they reached the posttreatment phase, the parents who had completed the full 42 hours of the MFT program perceived their children's ADHD symptoms as being less serious and less pathological than they had originally thought compared to the parents in the control group. The effect of MFT on parent-child relationships, parenting stress, parental efficacy, hope, and perceived social support was statistically insignificant. Contributions and limitations of our study are discussed. © 2017 Family Process Institute.

A Randomized Controlled Trial of Brief and Ultrabrief Pulse Right Unilateral Electroconvulsive Therapy

PubMed Central

Katalinic, Natalie; Smith, Deirdre J.; Ingram, Anna; Dowling, Nathan; Martin, Donel; Addison, Kerryn; Hadzi-Pavlovic, Dusan; Simpson, Brett; Schweitzer,, Isaac

2015-01-01

Background: Some studies suggest better overall outcomes when right unilateral electroconvulsive therapy (RUL ECT) is given with an ultrabrief, rather than brief, pulse width. Methods: The aim of the study was to test if ultrabrief-pulse RUL ECT results in less cognitive side effects than brief- pulse RUL ECT, when given at doses which achieve comparable efficacy. One hundred and two participants were assigned to receive ultrabrief (at 8 times seizure threshold) or brief (at 5 times seizure threshold) pulse RUL ECT in a double-blind, randomized controlled trial. Blinded raters assessed mood and cognitive functioning over the ECT course. Results: Efficacy outcomes were not found to be significantly different. The ultrabrief group showed less cognitive impairment immediately after a single session of ECT, and over the treatment course (autobiographical memory, orientation). Conclusions: In summary, when ultrabrief RUL ECT was given at a higher dosage than brief RUL ECT (8 versus 5 times seizure threshold), efficacy was comparable while cognitive impairment was less. PMID:25522389

Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies.

PubMed

Prins, Martin H; Lensing, Anthonie Wa; Bauersachs, Rupert; van Bellen, Bonno; Bounameaux, Henri; Brighton, Timothy A; Cohen, Alexander T; Davidson, Bruce L; Decousus, Hervé; Raskob, Gary E; Berkowitz, Scott D; Wells, Philip S

2013-09-20

Standard treatment for venous thromboembolism (VTE) consists of a heparin combined with vitamin K antagonists. Direct oral anticoagulants have been investigated for acute and extended treatment of symptomatic VTE; their use could avoid parenteral treatment and/or laboratory monitoring of anticoagulant effects. A prespecified pooled analysis of the EINSTEIN-DVT and EINSTEIN-PE studies compared the efficacy and safety of rivaroxaban (15 mg twice-daily for 21 days, followed by 20 mg once-daily) with standard-therapy (enoxaparin 1.0 mg/kg twice-daily and warfarin or acenocoumarol). Patients were treated for 3, 6, or 12 months and followed for suspected recurrent VTE and bleeding. The prespecified noninferiority margin was 1.75. A total of 8282 patients were enrolled; 4151 received rivaroxaban and 4131 received standard-therapy. The primary efficacy outcome occurred in 86 (2.1%) rivaroxaban-treated patients compared with 95 (2.3%) standard-therapy-treated patients (hazard ratio, 0.89; 95% confidence interval [CI], 0.66-1.19; pnoninferiority < 0.001). Major bleeding was observed in 40 (1.0%) and 72 (1.7%) patients in the rivaroxaban and standard-therapy groups, respectively (hazard ratio, 0.54; 95% CI, 0.37-0.79; p = 0.002). In key subgroups, including fragile patients, cancer patients, patients presenting with large clots, and those with a history of recurrent VTE, the efficacy and safety of rivaroxaban were similar compared with standard-therapy. The single-drug approach with rivaroxaban resulted in similar efficacy to standard-therapy and was associated with a significantly lower rate of major bleeding. Efficacy and safety results were consistent among key patient subgroups. ClinicalTrials.gov, NCT00439777; EINSTEIN-DVT: ClinicalTrials.gov, NCT00440193.

Efficacy and safety of golimumab in Indian patients with rheumatoid arthritis: Subgroup data from GO-MORE study.

PubMed

Pal, Sarvajeet; Veeravalli, Sarath Chandra Mouli; Das, Siddharth Kumar; Shobha, Vineeta; Uppuluri, Ramakrishna Rao; Dharmanand, B G; Nadkar, Milind; Hsia, Elizabeth; Fei, Kaiyin; Yao, Ruji; Khalifa, Ahmed

2016-11-01

To conduct a subgroup analysis of GO-MORE trial Part 1, comparing efficacy and safety of add-on subcutaneous golimumab therapy in rheumatoid arthritis (RA) patients enrolled from and outside India. GO-MORE was an open-label, multicenter, prospective trial of add-on golimumab in biologic-naïve RA patients, having active disease despite being on conventional DMARD regimen(s). Part 1 of the study was chosen as the focus of this subgroup analysis because a substantial number of Indian patients (106) were enrolled compared to no Indian patients in Part 2. The primary efficacy outcome was proportion of patients achieving good to moderate DAS28-ESR (Disease Activity Score of 28 joints calculated using erythrocyte sedimentation rate) European League Against Rheumatism (EULAR) response at month 6. Efficacy evaluable population comprised of 105 and 3175 patients from India and outside India, respectively. Safety analysis included 106 patients enrolled from India and 3251 from outside India. A higher proportion of Indian patients had a high disease activity as measured by DAS28 ESR than outside India patients. At month 6, the proportion of Indian and non-Indian patients achieving DAS28-ESR, DAS28 - C-reactive protein, simplified disease activity index (SDAI) remission, and EuroQoL Quality-of-Life Questionnaire (EQ-5D) scores were comparable. Incidence of all adverse events was lower in Indian patients. There were no deaths, cases of tuberculosis or malignancy reported in the patients from India at month 6. The efficacy and safety results with add-on golimumab were consistent between RA patients from India and outside India, despite high baseline disease activity in the Indian patients. © 2016 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

The Efficacy of Internet-based Cognitive Behavioral Therapy on the Anxiety Disorders among Adolescent Girls.

PubMed

Karbasi, Afsaneh; Haratian, Azadeh

2018-01-01

The prevalence of anxiety disorders among children and adolescents are found to be approximately between 8-12 and 5-10, respectively, and the long-lasting effects of such disorders can expose the sufferers to impairment and dysfunction in several areas of life the examples of which are poor educational performance, low self-esteem, and depression. The present study aims to evaluate the efficacy of internet-based, cognitive-behavioral therapy (ICBT) in treating the anxiety disorders among adolescent females. The sample included thirty girls aged between 10 and 18 years suffering from a variety of anxiety disorders, under pharmaceutical therapy and referred to clinics of child and adolescent psychiatry specialists in Isfahan. The sample was selected through diagnostic interviews by psychiatrists based on the Diagnostic and Statistical Manual of Mental Disorders, 4 th Edition, Text Revision; afterward, they were randomly assigned to either the experimental or the control groups. To evaluate the efficacy of an ICBT in reducing anxiety disorder symptoms, Screen for Child Anxiety Related Emotional Disorders questionnaire was administered among the patients both before and 4 weeks after the treatment. The covariance analysis results aimed to compare the anxiety disorder score variations between the two groups which demonstrate the fact that anxiety disorder scores in these two groups differ from one another ( P < 0.001). This study is comprised of two Conclusions.the significant reduction in the mean of anxiety disorders scores in the experimental group compared to those in control group can be indicative of the efficacy of ICBT. In addition the significant reduction in the average of anxiety disorders symptoms' scores according to the type of anxiety disorders in the experimental group, compared to those in control group, can be indicative of the efficacy of ICBT.

Arthritis Self-Efficacy and Self-Efficacy for Resisting Eating: Relationships to Pain, Disability, and Eating Behavior in Overweight and Obese Individuals with Osteoarthritic Knee Pain

PubMed Central

Pells, Jennifer J.; Shelby, Rebecca A.; Keefe, Francis J.; Dixon, Kim E.; Blumenthal, James A.; LaCaille, Lara; Tucker, Jessica M.; Schmitt, Daniel; Caldwell, David S.; Kraus, Virginia B.

2008-01-01

This study examined arthritis self-efficacy and self-efficacy for resisting eating as predictors of pain, disability, and eating behaviors in overweight or obese patients with osteoarthritis (OA) of the knee. Patients (N=174) with a body mass index between 25 and 42 completed measures of arthritis-related self-efficacy, weight-related self-efficacy, pain, physical disability, psychological disability, overeating, and demographic and medical information. Hierarchical linear regression analyses were conducted to examine whether arthritis self-efficacy (efficacy for pain control, physical function, and other symptoms) and self-efficacy for resisting eating accounted for significant variance in pain, disability, and eating behaviors after controlling for demographic and medical characteristics. Analyses also tested whether the contributions of self-efficacy were domain specific. Results showed that self-efficacy for pain accounted for 14% (p=.01) of the variance in pain, compared to only 3% accounted for by self-efficacy for physical function and other symptoms. Self-efficacy for physical function accounted for 10% (p=.001) of the variance in physical disability, while self-efficacy for pain and other symptoms accounted for 3%. Self-efficacy for other (emotional) symptoms and resisting eating accounted for 21% (p<.05) of the variance in psychological disability, while self-efficacy for pain control and physical function were not significant predictors. Self-efficacy for resisting eating accounted for 28% (p=.001) of the variance in eating behaviors. Findings indicate that self-efficacy is important in understanding pain and behavioral adjustment in overweight or obese OA patients. Moreover, the contributions of self-efficacy were domain specific. Interventions targeting both arthritis self-efficacy and self-efficacy for resisting eating may be helpful in this population. PMID:17764844

A comparative study of ethylene oxide gas, hydrogen peroxide gas plasma, and low-temperature steam formaldehyde sterilization.

PubMed

Kanemitsu, Keiji; Imasaka, Takayuki; Ishikawa, Shiho; Kunishima, Hiroyuki; Harigae, Hideo; Ueno, Kumi; Takemura, Hiromu; Hirayama, Yoshihiro; Kaku, Mitsuo

2005-05-01

To compare the efficacies of ethylene oxide gas (EOG), hydrogen peroxide gas plasma (PLASMA), and low-temperature steam formaldehyde (LTSF) sterilization methods. The efficacies of EOG, PLASMA, and LTSF sterilization were tested using metal and plastic plates, common medical instruments, and three process challenge devices with narrow lumens. All items were contaminated with Bacillus stearothermophilus spores or used a standard biological indicator. EOG and LTSF demonstrated effective killing of B. stearothermophilus spores, with or without serum, on plates, on instruments, and in process challenge devices. PLASMA failed to adequately sterilize materials on multiple trials in several experiments, including two of three plates, two of three instruments, and all process challenge devices. Our results suggest that PLASMA sterilization may be unsuccessful under certain conditions, particularly when used for items with complex shapes and narrow lumens. Alternatively, LTSF sterilization demonstrates excellent efficacy and is comparable to EOG sterilization. LTSF could potentially act as a substitute if EOG becomes unavailable due to environmental concerns.

Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department.

PubMed

Reynolds, Stacy L; Studnek, Jonathan R; Bryant, Kathleen; VanderHave, Kelly; Grossman, Eric; Moore, Charity G; Young, James; Hogg, Melanie; Runyon, Michael S

2016-09-08

Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage. This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 μg/kg) for analgesia in 80 children aged 4-17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug. This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial. NCT02521415. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The Relationship between Occurrence Timing of Dispensing Errors and Subsequent Danger to Patients under the Situation According to the Classification of Drugs by Efficacy.

PubMed

Tsuji, Toshikazu; Nagata, Kenichiro; Kawashiri, Takehiro; Yamada, Takaaki; Irisa, Toshihiro; Murakami, Yuko; Kanaya, Akiko; Egashira, Nobuaki; Masuda, Satohiro

2016-01-01

There are many reports regarding various medical institutions' attempts at the prevention of dispensing errors. However, the relationship between occurrence timing of dispensing errors and subsequent danger to patients has not been studied under the situation according to the classification of drugs by efficacy. Therefore, we analyzed the relationship between position and time regarding the occurrence of dispensing errors. Furthermore, we investigated the relationship between occurrence timing of them and danger to patients. In this study, dispensing errors and incidents in three categories (drug name errors, drug strength errors, drug count errors) were classified into two groups in terms of its drug efficacy (efficacy similarity (-) group, efficacy similarity (+) group), into three classes in terms of the occurrence timing of dispensing errors (initial phase errors, middle phase errors, final phase errors). Then, the rates of damage shifting from "dispensing errors" to "damage to patients" were compared as an index of danger between two groups and among three classes. Consequently, the rate of damage in "efficacy similarity (-) group" was significantly higher than that in "efficacy similarity (+) group". Furthermore, the rate of damage is the highest in "initial phase errors", the lowest in "final phase errors" among three classes. From the results of this study, it became clear that the earlier the timing of dispensing errors occurs, the more severe the damage to patients becomes.

Communication practices in the US and Syria.

PubMed

Merkin, Rebecca S; Ramadan, Reem

2016-01-01

This study highlights Syrian communication practices using comparative tests with the United States communication as a baseline. Additionally, theoretical findings on individualism and collectivism theory are extended to include findings from Syria. Multivariate Analysis of Covariance was used to test culture's effect in demographically similar (in age, SES, and education) student convenience samples, with the covariate communication adaptability, on dependent variables: empathy, social confirmation, social composure, friendships, non-verbal immediacy, social self-efficacy, and general self-efficacy. Results indicated that Syrians possess more empathy, social confirmation, and perceived general self-efficacy in comparison to U.S. citizens who have greater social composure, friendships, non-verbal immediacy and social self-efficacy. These results indicate that Syrians have the strength of self-efficacy to succeed in intercultural relationships while U.S. Americans have the assets of warmth and sociability to enable successful interactions with Syrians.

Comparative Effects of Stimulant Drugs in Hyperkinetic Children.

ERIC Educational Resources Information Center

Conners, C. Keith

The study compared the efficacy, side effects, and safety of magnesium pemoline (Cylert) and destroamphetamine (Dexedrine) as compared with placebo. Subjects were 81 children, ages 6-12 years, who evidenced one or more signs of minimal brain dysfunction, and were referred with major complaints of hyperactivity, short attention span,…

An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia.

PubMed

Huang, Xinfang; Du, Hui; Gu, Jieruo; Zhao, Dongbao; Jiang, Lindi; Li, Xinfu; Zuo, Xiaoxia; Liu, Yi; Li, Zhanguo; Li, Xiangpei; Zhu, Ping; Li, Juan; Zhang, Zhiyi; Huang, Anbin; Zhang, Yuanchao; Bao, Chunde

2014-07-01

Febuxostat, a novel non-purine selective inhibitor of xanthine oxidase, has been identified as a potential alternative to allopurinol in patients with hyperuricemia. The purpose of this study was to compare the urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia. Gout patients (n = 512) with serum uric acid (sUA) concentrations of at least 8.0 mg/dL were randomized to receive daily febuxostat 40 mg or 80 mg or allopurinol 300 mg for 28 weeks. Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks 1 through 8. The primary endpoint was the percentage of subjects achieving a sUA concentration of <6.0 mg/dL at the last three monthly measurements. The primary endpoint was reached in 44.77% of patients receiving 80 mg of febuxostat, 27.33% of those receiving 40 mg of febuxostat, and 23.84% of those receiving allopurinol. The UL efficacy in the febuxostat 80 mg group was higher than in the allopurinol (P < 0.0001) and febuxostat 40 mg (P = 0.0008) groups. The UL efficacy of the febuxostat 40 mg group was statistically non-inferior to that of the allopurinol group. No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group. The rate of gout flares requiring treatment from weeks 9 through 28 and the incidence of adverse events was similar among treatment groups. The UL efficacy of daily febuxostat 80 mg was greater than that of febuxostat 40 mg and allopurinol 300 mg, which exhibited comparable UL efficacy. Safety of febuxostat and allopurinol was comparable at the doses tested. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Atorvastatin calcium encapsulated eudragit nanoparticles with enhanced oral bioavailability, safety and efficacy profile.

PubMed

Kumar, Nagendra; Chaurasia, Sundeep; Patel, Ravi R; Khan, Gayasuddin; Kumar, Vikas; Mishra, Brahmeshwar

2017-03-01

Atorvastatin calcium (ATR), a second generation statin drug, was encapsulated in eudragit RSPO-based polymeric nanoparticles. The effect of independent variables (polymer content, stabilizer concentration, volume of chloroform and homogenization speed) on response variables (mean diameter particle size and entrapment efficiency) were investigated by employing central composite experimental design. All the independent variables were found to be significant for determining the response variables. Solid-state characterization study indicated the absence of physicochemical interaction between drug and polymer in formulation. Morphological study exhibited homogenous spherical shape of formulated nanoparticles. In vitro release study in phosphate buffer (pH 7.4) demonstrated sustained release profile over 24 h. Pharmacokinetic study in Charles Foster rats showed significant enhancement in oral bioavailability as compared to pure drug suspension. Efficacy study (lipid profile and blood glucose level) significantly justified the effectiveness of formulation having 50% less dose of ATR as compared to pure drug suspension. The effectiveness of formulation was further justified with an improved plasma safety profile of treated rats. Hence, ATR encapsulated eudragit RSPO nanoparticles can serve as potential drug delivery approach to enhance drug bioavailability, efficacy and safety profiles to alter existing marketed drug products.

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: Fifty-Two-Week Phase III Randomized Study Results.

PubMed

Weinblatt, Michael E; Baranauskaite, Asta; Dokoupilova, Eva; Zielinska, Agnieszka; Jaworski, Janusz; Racewicz, Artur; Pileckyte, Margarita; Jedrychowicz-Rosiak, Krystyna; Baek, Inyoung; Ghil, Jeehoon

2018-06-01

The 24-week equivalent efficacy and comparable safety results of the biosimilar SB5 and reference adalimumab (ADA) from the phase III randomized study in patients with moderate-to-severe rheumatoid arthritis (RA) have been reported previously. We undertook this transition study to evaluate patients who switched from ADA to SB5 or who continued to receive SB5 or ADA up to 52 weeks. In this phase III study, patients were initially randomized 1:1 to receive SB5 or ADA (40 mg subcutaneously every other week). At 24 weeks, patients receiving ADA were rerandomized 1:1 to continue with ADA (ADA/ADA group) or to switch to SB5 (ADA/SB5 group) up to week 52; patients receiving SB5 continued with SB5 for 52 weeks (SB5 group). Efficacy, safety, and immunogenicity were evaluated up to 52 weeks. The full analysis set population consisted of 542 patients (269 in the SB5 group, 273 in the ADA overall group [patients who were randomized to receive ADA at week 0], 125 in the ADA/SB5 group, and 129 in the ADA/ADA group). The percentages of patients meeting the American College of Rheumatology 20%, 50%, or 70% improvement criteria (achieving an ACR20, ACR50, or ACR70 response) at week 24 were maintained after the transition from ADA to SB5, and these response rates were comparable across treatment groups throughout the study. ACR20 response rates ranged from 73.4% to 78.8% at week 52. Radiographic progression was minimal and comparable across treatment groups. The safety profile and the incidence of antidrug antibodies were comparable across treatment groups after transition. SB5 was well tolerated over 1 year in patients with RA, with efficacy, safety, and immunogenicity comparable to those of ADA. Switching from ADA to SB5 had no treatment-emergent issues such as increased adverse events, increased immunogenicity, or loss of efficacy. © 2018 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

Efficacy of a piroctone olamine/climbazol shampoo in comparison with a zinc pyrithione shampoo in subjects with moderate to severe dandruff.

PubMed

Schmidt-Rose, T; Braren, S; Fölster, H; Hillemann, T; Oltrogge, B; Philipp, P; Weets, G; Fey, S

2011-06-01

Dandruff is a chronic scalp disorder characterized by scaling and itching. A successful anti-dandruff shampoo not only has to provide superior anti-dandruff relief to ensure patient compliance. It also needs to offer excellent cosmetic and hair conditioning benefits at the same time. In this study, the efficacy of a shampoo containing 0.5% piroctone olamine and 0.45% climbazole (shampoo 1) was compared with a widely available commercial shampoo containing 1% zinc pyrithione (shampoo 2). In vitro studies investigating the anti-mycotic efficacy of a combination of 0.5% piroctone olamine and 0.45% climbazole as well as 1% zinc pyrithione were performed. To study substantivity, pig skin punches were used as a model system and a test of wet combability was performed to characterize combing ease. In vivo home-in-use studies were carried out to determine the efficacy of both shampoos to improve scalp condition and reduce itching in subjects suffering from moderate to severe dandruff. Results demonstrated a comparable anti-fungal effectiveness for 0.5% piroctone olamine plus 0.45% climbazole and 1% zinc pyrithione, respectively. Shampoo 1 showed a significantly higher anti-mycotics substantivity compared to shampoo 2. After treatment with shampoo 1, the wet combing force was significantly reduced compared with shampoo 2, suggesting a better combability following the use of shampoo 1. In an in vivo split head design study, shampoo 1 was shown to be equally effective in reducing the amount of dandruff on the scalp compared with shampoo 2. The approval rate of volunteers regarding the question 'The use of this shampoo decreases the itching of my scalp?' after a 4-week treatment with shampoo 1 equaled 90%. Overall, the shampoo formulation with 0.5% piroctone olamine and 0.45% climbazole effectively reduces the amount of dandruff and, at the same time, provides hair conditioning advantages. © 2011 The Authors. ICS © 2011 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

Efficacy of Three-Week Oxytetracycline or Rifampin Monotherapy Compared with a Combination Regimen against the Filarial Nematode Onchocerca ochengi

PubMed Central

Bah, Germanus S.; Ward, Emma L.; Srivastava, Abhishek; Trees, Alexander J.; Tanya, Vincent N.

2014-01-01

Onchocerciasis (river blindness), caused by the filarial nematode Onchocerca volvulus, is a major cause of visual impairment and dermatitis in sub-Saharan Africa. As O. volvulus contains an obligatory bacterial symbiont (Wolbachia), it is susceptible to antibiotic chemotherapy, although current regimens are considered too prolonged for community-level control programs. The aim of this study was to compare the efficacies of oxytetracycline and rifampin, administered separately or in combination, against a close relative of O. volvulus (Onchocerca ochengi) in cattle. Six animals per group were treated with continuous or intermittent oxytetracycline regimens, and effects on adult worm viability, dermal microfilarial loads, and Wolbachia density in worm tissues were assessed. Subsequently, the efficacies of 3-week regimens of oxytetracycline and rifampin alone and a combination regimen were compared, and rifampin levels in plasma and skin were quantified. A 6-month regimen of oxytetracycline with monthly dosing was strongly adulticidal, while 3-week and 6-week regimens exhibited weaker adulticidal effects. However, all three regimens achieved >2-log reductions in microfilarial load. In contrast, rifampin monotherapy and oxytetracycline-rifampin duotherapy failed to induce substantive reductions in either adult worm burden or microfilarial load, although a borderline effect on Wolbachia density was observed following duotherapy. Dermal rifampin levels were maintained above the MIC for >24 h after a single intravenous dose. We conclude that oxytetracycline-rifampin duotherapy is less efficacious against O. ochengi than oxytetracycline alone. Further studies will be required to determine whether rifampin reduces oxytetracycline bioavailability in this system, as suggested by human studies using other tetracycline-rifampin combinations. PMID:24247133

Efficacy of three-week oxytetracycline or rifampin monotherapy compared with a combination regimen against the filarial nematode Onchocerca ochengi.

PubMed

Bah, Germanus S; Ward, Emma L; Srivastava, Abhishek; Trees, Alexander J; Tanya, Vincent N; Makepeace, Benjamin L

2014-01-01

Onchocerciasis (river blindness), caused by the filarial nematode Onchocerca volvulus, is a major cause of visual impairment and dermatitis in sub-Saharan Africa. As O. volvulus contains an obligatory bacterial symbiont (Wolbachia), it is susceptible to antibiotic chemotherapy, although current regimens are considered too prolonged for community-level control programs. The aim of this study was to compare the efficacies of oxytetracycline and rifampin, administered separately or in combination, against a close relative of O. volvulus (Onchocerca ochengi) in cattle. Six animals per group were treated with continuous or intermittent oxytetracycline regimens, and effects on adult worm viability, dermal microfilarial loads, and Wolbachia density in worm tissues were assessed. Subsequently, the efficacies of 3-week regimens of oxytetracycline and rifampin alone and a combination regimen were compared, and rifampin levels in plasma and skin were quantified. A 6-month regimen of oxytetracycline with monthly dosing was strongly adulticidal, while 3-week and 6-week regimens exhibited weaker adulticidal effects. However, all three regimens achieved >2-log reductions in microfilarial load. In contrast, rifampin monotherapy and oxytetracycline-rifampin duotherapy failed to induce substantive reductions in either adult worm burden or microfilarial load, although a borderline effect on Wolbachia density was observed following duotherapy. Dermal rifampin levels were maintained above the MIC for >24 h after a single intravenous dose. We conclude that oxytetracycline-rifampin duotherapy is less efficacious against O. ochengi than oxytetracycline alone. Further studies will be required to determine whether rifampin reduces oxytetracycline bioavailability in this system, as suggested by human studies using other tetracycline-rifampin combinations.

Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation.

PubMed

Rafati, Mr; Karami, H; Salehifar, E; Karimzadeh, A

2011-01-01

Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008-2009. Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2-12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0-1.5 g/kg/day PEG 3350 or 1.0-1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events.

Neoadjuvant chemotherapy regimens in treatment of breast cancer: a systematic review and network meta-analysis protocol.

PubMed

Pathak, Mona; Dwivedi, Sada Nand; Deo, S V S; Thakur, Bhaskar; Sreenivas, Vishnubhatla; Rath, G K

2018-06-26

Neoadjuvant chemotherapy (NACT), a standard of care for locally advanced breast cancer patients, is widely used for early breast cancer patients also. The varying role of regimens used as NACT needs to be investigated. Despite availability of some randomized controlled trials (RCTs), it is unclear which treatment regimen suits best. Further, there is no study comparing all the three regimens. Accordingly, present study will compare the efficacy of anthracyclines, taxanes, and targeted therapy administered in neoadjuvant setting on the basis of oncological outcomes and functional outcomes. Online databases PubMed and Cochrane Register of Controlled Trials will be searched to acquire eligible studies. Further, content of relevant journals, references of relevant articles, and proceedings of major related conference will also be searched. The RCTs comparing any of abovementioned regimen as NACT on breast cancer patients will be eligible. Two reviewers independently and in duplicate will screen the records on the basis of title and abstract and complete full-text review to determine eligibility. Similarly, data extraction and risk of bias assessment will be done by two independent reviewers. The pair-wise meta-analysis as well as network meta-analysis will be conducted to assess the relative efficacy of anthracyclines, taxanes, and targeted therapy regimens. The present systematic review will improve the understanding of the relative efficacies of the three treatment regimens and possibly guide the clinical practices by providing the current best evidence on the efficacy of various regimens of NACT in the management of breast cancer patients. PROSPERO ( CRD42016027236 ).

Moist Exposed Burn Ointment (MEBO) in partial thickness burns - a randomized, comparative open mono-center study on the efficacy of dermaheal (MEBO) ointment on thermal 2nd degree burns compared to conventional therapy.

PubMed

Hirsch, T; Ashkar, W; Schumacher, O; Steinstraesser, L; Ingianni, G; Cedidi, C C

2008-11-24

Wound healing in burn wounds presents a challenge in healthcare, and there is still a lack of alternatives in topical burn wound treatments. - The purpose of this study was to evaluate the efficacy of a new therapeutic ointment (MEBO) in the treatment of partial thickness burns. 40 patients received either topical treatment with Moist Exposed Burn Ointment (MEBO) or standard Flammazine treatment. All patients suffered from partial-thickness burn injuries (< 20% TBSA). Wounds were evaluated for 60 up to days regarding wound healing, water loss, inflammation, and pain alleviation. For transepidermal water loss, there was a difference of 2.3 gr/m2/h between MEBO, and Flammazine, favoring MEBO. However, this difference was not statistically significant (p=0.78). For all secondary efficacy parameter results were similar. - This study showed that MEBO ointment for topical treatment of burn injuries presents an attractive alternative for the topical treatment of limited partial thickness thermal burns.

A comparative study of different strategies for removal of endotoxins from bacteriophage preparations.

PubMed

Van Belleghem, Jonas D; Merabishvili, Maya; Vergauwen, Bjorn; Lavigne, Rob; Vaneechoutte, Mario

2017-01-01

Bacterial endotoxins have high immunogenicity. Phage biology studies as well as therapeutic phage applications necessitate highly purified phage particles. In this study, we compared combinations of seven different endotoxin removal strategies and validated their endotoxin removal efficacy for five different phages (i.e. four Pseudomonas aeruginosa phages and one Staphylococcus aureus phage). These purification strategies included Endotrap HD column purification and/or CsCl density centrifugation in combination with Endotrap purification, followed by organic solvent (1-octanol), detergent (Triton X-100), enzymatic inactivation of the endotoxin using alkaline phosphatase and CIM monolytic anion exchange chromatography. We show that CsCl density purification of the P. aeruginosa phages, at an initial concentration of 10 12 -10 13 pfu/ml, led to the strongest reduction of endotoxins, with an endotoxin removal efficacy of up to 99%, whereas additional purification methods did not result in a complete removal of endotoxins from the phage preparations and only yielded an additional endotoxin removal efficacy of 23 to 99%, sometimes accompanied with strong losses in phage titer. Copyright © 2016 Elsevier B.V. All rights reserved.

The Value of Removing Daily Obstacles via Everyday Problem-Solving Theory: Developing an Applied Novel Procedure to Increase Self-Efficacy for Exercise

PubMed Central

Artistico, Daniele; Pinto, Angela Marinilli; Douek, Jill; Black, Justin; Pezzuti, Lina

2012-01-01

The objective of the study was to develop a novel procedure to increase self-efficacy for exercise. Gains in one’s ability to resolve day-to-day obstacles for entering an exercise routine were expected to cause an increase in self-efficacy for exercise. Fifty-five sedentary participants (did not exercise regularly for at least 4 months prior to the study) who expressed an intention to exercise in the near future were selected for the study. Participants were randomly assigned to one of three conditions: (1) an Experimental Group in which they received a problem-solving training session to learn new strategies for solving day-to-day obstacles that interfere with exercise, (2) a Control Group with Problem-Solving Training which received a problem-solving training session focused on a typical day-to-day problem unrelated to exercise, or (3) a Control Group which did not receive any problem-solving training. Assessment of obstacles to exercise and perceived self-efficacy for exercise were conducted at baseline; perceived self-efficacy for exercise was reassessed post-intervention (1 week later). No differences in perceived challenges posed by obstacles to exercise or self-efficacy for exercise were observed across groups at baseline. The Experimental Group reported greater improvement in self-efficacy for exercise compared to the Control Group with Training and the Control Group. Results of this study suggest that a novel procedure that focuses on removing obstacles to intended planned fitness activities is effective in increasing self-efficacy to engage in exercise among sedentary adults. Implications of these findings for use in applied settings and treatment studies are discussed. PMID:23372560

The Value of Removing Daily Obstacles via Everyday Problem-Solving Theory: Developing an Applied Novel Procedure to Increase Self-Efficacy for Exercise.

PubMed

Artistico, Daniele; Pinto, Angela Marinilli; Douek, Jill; Black, Justin; Pezzuti, Lina

2013-01-01

The objective of the study was to develop a novel procedure to increase self-efficacy for exercise. Gains in one's ability to resolve day-to-day obstacles for entering an exercise routine were expected to cause an increase in self-efficacy for exercise. Fifty-five sedentary participants (did not exercise regularly for at least 4 months prior to the study) who expressed an intention to exercise in the near future were selected for the study. Participants were randomly assigned to one of three conditions: (1) an Experimental Group in which they received a problem-solving training session to learn new strategies for solving day-to-day obstacles that interfere with exercise, (2) a Control Group with Problem-Solving Training which received a problem-solving training session focused on a typical day-to-day problem unrelated to exercise, or (3) a Control Group which did not receive any problem-solving training. Assessment of obstacles to exercise and perceived self-efficacy for exercise were conducted at baseline; perceived self-efficacy for exercise was reassessed post-intervention (1 week later). No differences in perceived challenges posed by obstacles to exercise or self-efficacy for exercise were observed across groups at baseline. The Experimental Group reported greater improvement in self-efficacy for exercise compared to the Control Group with Training and the Control Group. Results of this study suggest that a novel procedure that focuses on removing obstacles to intended planned fitness activities is effective in increasing self-efficacy to engage in exercise among sedentary adults. Implications of these findings for use in applied settings and treatment studies are discussed.

An Evaluation of Instructional Coaching at Selected High Schools in North Louisiana and Its Effect on Student Achievement, Organizational Climate, and Teacher Efficacy

ERIC Educational Resources Information Center

Hearn, Richard M.

2010-01-01

The purpose of this study was to compare high schools in north Louisiana to determine if the presence or absence of instructional coaches influenced student achievement, organizational climate, and/or teacher efficacy in any significant manner. The 11 high schools in north Louisiana utilizing instructional coaches were matched to 11 high schools…

Preparing Students for the 21st Century: Exploring the Effect of Afterschool Participation on Students' Collaboration Skills, Oral Communication Skills, and Self-Efficacy. CRESST Report 777

ERIC Educational Resources Information Center

Huang, Denise; Leon, Seth; Hodson, Cheri; La Torre, Deborah; Obregon, Nora; Rivera, Gwendelyn

2010-01-01

This study addressed key questions about LA's BEST afterschool students' self-efficacy, collaboration, and communication skills. We compared student perceptions of their own 21st century skills to external outcome measures including the California Standardized Test (CST), attendance, and teacher ratings. We found a substantial relationship…

The Effects of a School-Based Nutrition Intervention on Fruit and Vegetable Preferences, Self-Efficacy, and Consumption among Low-Income, Hispanic and White Middle-School Students

ERIC Educational Resources Information Center

McCarthy, Erin; Wolff, Cindy; Bianco-Simeral, Stephanie; Crozier, Joseph; Goto, Keiko

2012-01-01

Purpose/Objectives: This study examined the effect of the Harvest of the Month (HOTM) nutrition education intervention program on middle-school students' fruit and vegetable preferences, self-efficacy and attitudes, and self-reported consumption. Perceptions of socio-environmental factors and demographic characteristics were also compared to…

A Comparison of the Effects of Three Intervention Approaches on Parental Self-Efficacy, Parenting Skills, and Parental Stress Levels of Impoverished Parents

ERIC Educational Resources Information Center

Rooney, MaryEllen

2012-01-01

The purpose of this study is to compare three intervention approaches that focused on alleviating some of the deleterious effects of poverty by building parental self-efficacy, increasing parenting skills, and decreasing parental stress levels in parents at-risk for negative child outcomes due to factors associated with adverse socioeconomic…

The Relationship between Career Decision-Making Self-Efficacy and Perceived Career Barriers in the Career Decision Making of Selected Community College Students

ERIC Educational Resources Information Center

Kelly, Rosemary Ritter

2010-01-01

This study explored the differences between career decision-making self-efficacy (CDMSE) and perceived career barriers of students enrolled in the applied technology program compared to those enrolled in a college transfer program at a southeastern urban community college. Participants in the ex-post facto cross-sectional survey included 787…

Adalimumab for treating childhood plaque psoriasis: a clinical trial evaluation.

PubMed

Di Lernia, Vito

2017-12-01

Most systemic therapies have not been systematically investigated in moderate to severe childhood plaque psoriasis. Evidence on the efficacy and safety of systemic treatments is limited and therapeutic guidelines are lacking. Recently adalimumab, a fully human monoclonal antibody that binds tumor necrosis factor (TNF)- alpha, was investigated in childhood psoriasis. Adalimumab is licensed for many inflammatory conditions including chronic plaque psoriasis in adults. Areas covered: A randomized phase III study published provided favourable efficacy and safety data of adalimumab in childhood psoriasis. The active comparator was methotrexate. After 16 weeks of treatment, a PASI 75 score was achieved in 58% of patients within the adalimumab 0.8 mg/kg group compared with 32% of patients within the methotrexate group. Safety data gave no evidence of drug-related serious adverse events and no organ toxicity. This is the first randomised controlled study of either adalimumab or methotrexate in children and adolescents with psoriasis. Expert opinion: The aforementioned trial was the first to provide clinical data on adalimumab's efficacy and safety in the short term when treating children and adolescents with psoriasis. Through the use of an active comparator, this study has opened the way for the future assessment of systemic therapies in children and adolescent with this condition.

A Multimodal Evaluation of the Comparative Efficacy of Yoga versus a Patient Centered Support Group for Treating Chronic Pain in Gulf War Illness

DTIC Science & Technology

2016-10-01

AWARD NUMBER: W81XWH-14-1-0615 TITLE: A Multimodal Evaluation of the Comparative Efficacy of Yoga versus a Patient- Centered Support Group for...Annual 3. DATES COVERED 29 Sept 2015- 28 Sept 2016 4. TITLE AND SUBTITLE A Multimodal Evaluation of the Comparative Efficacy of Yoga versus a Patient...veterans as compared to a pain management (control) group. (In progress) 4. Determine if the health-related benefits of treatment persist after

Aminothiol Receptors for Decorporation of Intravenously Administered 60Co in the Rat

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

Levitskaia, Tatiana G.; Morris, James E.; Creim, Jeffrey A.

2010-01-01

The reported investigation provides a comparison of the oral decorporation efficacy of L-glutathione (GSH), L-cysteine (Cys), and a liposomal GSH formulation (ReadiSorb) toward systemic cobalt-60 (60Co) to that observed following intravenous administration of GSH and Cys in F344 rats. L-histidine (His) was tested intravenously to compare in vivo efficacy of the aminothiol GSH and Cys chelators with that of aminoimidazole (His) chelator. 60Co was administered to animals by intravenous injection, followed by intravenous or oral gavage doses of a chelator repeated at 24 hour intervals for a total of 5 doses. The results suggest that GSH and Cys are potentmore » decorporation agents for 60Co in the rat model, although the efficacy of treatment depends largely on systemic availability of a chelator. The intravenous GSH or Cys were most effective in reducing tissue 60Co levels and in increasing excretion of radioactivity compared to control animals. Liposomal encapsulation was found to markedly enhance the oral bioavailability of GSH compared to non-formulated GSH. Oral administration of ReadiSorb reduced 60Co levels in nearly all tissues by 12-43% compared to that observed for non-formulated GSH. Efficacy of oral Cys was only slightly reduced in comparison with intravenous Cys. Further studies to optimize the dosing regimen in order to maximize decorporation efficiency are warranted.« less

Acceptance and commitment therapy - Do we know enough? Cumulative and sequential meta-analyses of randomized controlled trials.

PubMed

Hacker, Thomas; Stone, Paul; MacBeth, Angus

2016-01-15

Acceptance and Commitment Therapy (ACT) has accrued a substantial evidence base. Recent systematic and meta-analytic reviews suggest that ACT is effective compared to control conditions. However, these reviews appraise the efficacy of ACT across a broad range of presenting problems, rather than addressing specific common mental health difficulties. Focussing on depression and anxiety we performed a meta-analysis of trials of ACT. We incorporated sequential meta-analysis (SMA) techniques to critically appraise the sufficiency of the existing evidence base. Findings suggest that ACT demonstrates at least moderate group and pre-post effects for symptom reductions for both anxiety and depression. However using SMA findings are more qualified. There is currently insufficient evidence to confidently conclude that ACT for anxiety is efficacious when compared to active control conditions or as primary treatment for anxiety. Similarly, using SMA, there is currently insufficient evidence to suggest a moderate efficacy of ACT for depression compared to active control conditions. To stimulate further research we offer specific estimates of additional numbers of participants required to reach sufficiency to help inform future studies. We also discuss the appropriate strategies for future research into ACT for anxiety given the current evidence suggests no differential efficacy of ACT in the treatment of anxiety compared to active control conditions. Copyright © 2015 Elsevier B.V. All rights reserved.

Evaluation of Brāhmī ghṛtam in children suffering from Attention Deficit Hyperactivity Disorder

PubMed Central

Bhalerao, Supriya; Munshi, Renuka; Nesari, Tanuja; Shah, Heenal

2013-01-01

Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is characterized by a persistent pattern of inattention and/or hyperactivity-impulsivity. In view of the adverse effects associated with psycho-stimulants used for the treatment of this disorder, efficacy of Brāhmī ghṛtam was evaluated in this condition. Materials and Methods: After following due ethical considerations, children of either sex between the age group of 6 and 12 years diagnosed to be suffering from mixed variety of ADHD as per The Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria irrespective of other co-morbid psychiatric illnesses were recruited in the study. Initially a pilot study (n = 10) was carried out to confirm the efficacy of the identified dose of Brāhmī ghṛtam. Using this dose, further therapeutic confirmatory study (n = 27) was carried out, wherein Brāhmī ghṛtam was compared with methylphenidate. Effect on ADHD symptoms was assessed using the Dupaul ADHD rating scale and this was the main efficacy parameter. Results: In the pilot exploratory study, Brāhmī ghṛtam showed 66% decrease in total ADHD score. In the therapeutic confirmatory study, only 16% improvement was seen with Brāhmī ghṛtam, which was similar to methylphenidate, standard treatment for ADHD that was used as a comparator in the present study. No side-effects were reported in both studies. Conclusion: Our study thus has adequately demonstrated efficacy and safety of Brāhmī ghṛtam in ADHD. PMID:25284947

Gestational Diabetes Mellitus Management with Oral Hypoglycemic Agents

PubMed Central

Ryu, Rachel J.; Hays, Karen E.; Hebert, Mary F.

2014-01-01

Oral hypoglycemic agents such as glyburide (second generation sulfonylurea) and metformin (biguanide) are attractive alternatives to insulin due to lower cost, ease of administration, and better patient adherence. The majority of evidence from retrospective and prospective studies suggests comparable efficacy and safety of oral hypoglycemic agents such as glyburide and metformin as compared to insulin when used in the treatment of women with gestational diabetes mellitus (GDM). Glyburide and metformin have altered pharmacokinetics during pregnancy and both agents cross the placenta. In this article, we review the efficacy, safety and dosage of oral hypoglycemic agents for the treatment of gestational diabetes mellitus. Additional research is needed to evaluate optimal dosage for glyburide and metformin during pregnancy. Comparative studies evaluating the effects of glyburide and metformin on long-term maternal and fetal outcomes are also needed. PMID:25315294

Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation

PubMed Central

Rafati, MR.; Karami, H.; Salehifar, E.; Karimzadeh, A.

2011-01-01

Background and the purpose of the study Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008–2009. Methods Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2–12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0–1.5 g/kg/day PEG 3350 or 1.0–1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Results and major conclusion Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events. PMID:22615652

Efficacy of acupuncture treatment for functional dyspepsia: A systematic review and meta-analysis.

PubMed

Kim, Ka-Na; Chung, Sun-Yong; Cho, Seung-Hun

2015-12-01

The use of acupuncture treatment (AT) for functional dyspepsia is increasing, particularly in Asia. However, the efficacy of AT and its side effects have not been assessed. We performed a systematic review and meta-analysis of studies related to the effectiveness of AT for functional dyspepsia. This study is a systemic review and meta-analysis. Seven electronic databases, including those in the English and Chinese languages, were systematically searched for randomized controlled trials of AT for functional dyspepsia through November 2012. There were no language restrictions. Randomized controlled trials (RCT) AT compared with placebo control or a comparative intervention were considered. The methodological qualities of the studies were evaluated using the risk of bias (ROB). Subgroups were analyzed according to the kinds of controls. The primary outcomes were symptom scores. These included visual analogue scale (VAS) and Nepean Dyspepsia Index (NDI). Secondary outcomes were the total effective rate and adverse effects. Twenty studies, including 1423 individual cases, were systematically reviewed. The risk of bias was high. Compared to sham AT, AT was associated with a significant positive effect in patients with functional dyspepsia (2.66, 95% CI 1.85-3.82). AT also improved symptoms for functional dyspepsia (1.18, 95% CI 1.01-2.60) compared to GI tract regulators on total effective rate. In addition, two articles produced a scale in favor of AT compared to medication (0.54, 95% CI 0.18-0.90). Two RCTs reported minimal AT-related adverse events. The evidence suggests that AT is effective for functional dyspepsia. However, well-planned, long-term studies are necessary to evaluate the efficacy of AT for functional dyspepsia. Copyright © 2015. Published by Elsevier Ltd.

In Vivo Anticancer Efficacy and Toxicity Studies of a Novel Polymer Conjugate N-Acetyl Glucosamine (NAG)-PEG-Doxorubicin for Targeted Cancer Therapy.

PubMed

Pawar, Smita; Mahajan, Ketan; Vavia, Pradeep

2017-11-01

A novel polymer-drug conjugate, polyethylene glycol-N-(acetyl)-glucosamine-doxorubicin (PEG-NAG-DOX) was evaluated in this study for its in vivo potential for treatment of tumours demonstrating improved efficacy and reduced toxicity. The proposed polymer-drug conjugate comprised of polyethylene glycol-maleimide (mPEG-MAL, 30000 Da) as a carrier, doxorubicin (DOX) as an anticancer drug and N-acetyl glucosamine (NAG) as a targeting moiety as well as penetration enhancer. Doxorubicin has a potent and promising anticancer activity; however, severe cardiotoxicity limits its application in cancer treatment. By modifying DOX in PEG-NAG-DOX prodrug conjugate, we aimed to eliminate this limitation. In vivo anticancer efficacy of the conjugate was evaluated using BDF mice-induced skin melanoma model by i.v. administration of DOX conjugates. Anticancer efficacy studies were done by comparing tumour volume, body weight, organ index and percent survival rate of the animals. Tumour suppression achieved by PEG-NAG-DOX at the cumulative dose of 7.5 mg/kg was two-fold better than that achieved by DOX solution. Also, the survival rate for PEG-NAG-DOX conjugate was >70% as compared to <50% survival rate for DOX solution. In addition, toxicity studies and histopathological studies revealed that while maintaining its cytotoxicity towards tumour cells, PEG-NAG-DOX conjugate showed no toxicities to major organs. Therefore, PEG-NAG-DOX conjugate can be suggested as a desirable candidate for targeted cancer therapy.

A randomized cross over study comparing the efficacy of two mandibular advancement appliances in the treatment of mild-moderate obstructive sleep apnea.

PubMed

Al-Dharrab, Ayman

2017-11-01

To compare efficacy, side effects, patient compliance, and preference between two types of custom-made mandibular advancement appliances (MAAs) in the treatment of patients with mild to moderate obstructive sleep apnea (OSA). This prospective, randomized, crossover study of 12 patients with mild to moderate OSA compared a titratable and a non-titratable MAA. Each patient was fitted with both appliances in a random order with a washout period of two weeks. Efficacy, side effects, compliance, and preference were evaluated by a questionnaire. All patients underwent overnight home sleep recordings prior to and after the use of each appliance in order to objectively assess sleep quality in terms of the apnea and hypopnea index (AHI), snoring frequency and oxygen desaturation index. Treatment successes (relief of symptoms and/or reduction of AHI to <10/h) were reported with both types of appliances. No compliance failure was reported, and in most patients, the side effects were mild, and improved with time. Both types of oral appliances were effective treatments for patients with mild to moderate OSA, with fewer side effects and higher patient satisfaction.

Psychomotor effect differences between l-methamphetamine and d-methamphetamine are independent of murine plasma and brain pharmacokinetics profiles.

PubMed

Nishimura, Tetsuya; Takahata, Kazue; Kosugi, Yuri; Tanabe, Takaaki; Muraoka, Shizuko

2017-05-01

l-Methamphetamine has been occasionally referred to as a stimulant similar to d-methamphetamine, probably owing to insufficient comparative studies. Here, we directly compared psychomotor efficacies and pharmacokinetics of methamphetamine enantiomers in mice. Only d-methamphetamine, but not l-methamphetamine, induced stereotypy and sensitization at 1-10 mg/kg. However, plasma pharmacokinetic parameters of 10 mg/kg l-methamphetamine were ≥tenfold those of 1 mg/kg d-methamphetamine. These results clearly indicate that differential psychomotor efficacies of methamphetamine enantiomers are independent of their pharmacokinetic profiles.

Economic analysis of Mycobacterium avium subspecies paratuberculosis vaccines in dairy herds.

PubMed

Cho, J; Tauer, L W; Schukken, Y H; Gómez, M I; Smith, R L; Lu, Z; Grohn, Y T

2012-04-01

Johne's disease, or paratuberculosis, is a chronic infectious enteric disease of ruminants, caused by infection with Mycobacterium avium ssp. paratuberculosis (MAP). Given the absence of a fail-safe method of prevention or a cure, Johne's disease can inflict significant economic loss on the US dairy industry, with an estimated annual cost of over $200 million. Currently available MAP control strategies include management measures to improve hygiene, culling MAP serologic- or fecal-positive adult cows, and vaccination. Although the 2 first control strategies have been reported to be effective in reducing the incidence of MAP infection, the changes in herd management needed to conduct these control strategies require significant effort on the part of the dairy producer. On the other hand, vaccination is relatively simple to apply and requires minor changes in herd management. Despite these advantages, only 5% of US dairy operations use vaccination to control MAP. This low level of adoption of this technology is due to limited information on its cost-effectiveness and efficacy and some important inherent drawbacks associated with current MAP vaccines. This study investigates the epidemiological effect and economic values of MAP vaccines in various stages of development. We create scenarios for the potential epidemiological effects of MAP vaccines, and then estimate economically justifiable monetary values at which vaccines become economically beneficial to dairy producers such that a net present value (NPV) of a farm's net cash flow can be higher than the NPV of a farm using no control or alternative nonvaccine controls. Any vaccination with either low or high efficacy considered in this study yielded a higher NPV compared with a no MAP control. Moreover, high-efficacy vaccines generated an even higher NPV compared with alternative controls, making vaccination economically attractive. Two high-efficacy vaccines were particularly effective in MAP control and NPV maximization. One was a high-efficacy vaccine that reduced susceptibility to MAP infection. The other was a high-efficacy vaccine that had multiple efficacies on the dynamics of MAP infection and disease progress. Only one high-efficacy vaccine, in which the vaccine is targeted at reducing MAP shedding and the number of clinical cases, was not economically beneficial to dairy producers compared with an alternative nonvaccine control, when herds were highly infected with MAP. Copyright © 2012 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Efficacy of sodium dodecyl sulphate and natural extracts against E. coli biofilm.

PubMed

Fink, Rok; Kulaš, Stefan; Oder, Martina

2018-05-02

The aim of this study was to determine and compare the efficacy of a standard cleaning agent, sodium dodecyl sulphate, and natural extracts from pomegranate peel grape skin and bay laurel leaf against E. coli biofilm. The biofilm was exposed for 10 minutes to three different concentrations of each tested compound. The results show that bay laurel leaf extract is the most efficient with 43% biofilm biomass reduction, followed by pomegranate peel extract (35%); sodium dodecyl sulphate and grape skin extract each have 30% efficacy. Our study demonstrated that natural extracts from selected plants have the same or even better efficacy against E. coli biofilm removal from surfaces than the tested classical cleaning agent do. All this indicates that natural plant extracts, which are acceptable from the health and environment points of view, can be potential substitutes for classical cleaning agents.

A quantitative approach to evaluating caring in nursing simulation.

PubMed

Eggenberger, Terry L; Keller, Kathryn B; Chase, Susan K; Payne, Linda

2012-01-01

This study was designed to test a quantitative method of measuring caring in the simulated environment. Since competency in caring is central to nursing practice, ways of including caring concepts in designing scenarios and in evaluation of performance need to be developed. Coates' Caring Efficacy scales were adapted for simulation and named the Caring Efficacy Scale-Simulation Student Version (CES-SSV) and Caring Efficacy Scale-Simulation Faculty Version (CES-SFV). A correlational study was designed to compare student self-ratings with faculty ratings on caring efficacy during an adult acute simulation experience with traditional and accelerated baccalaureate students in a nursing program grounded in caring theory. Student self-ratings were significantly correlated with objective ratings (r = 0.345, 0.356). Both the CES-SSV and the CES-SFV were found to have excellent internal consistency and significantly correlated interrater reliability. They were useful in measuring caring in the simulated learning environment.

Efficacy and safety of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus uncontrolled on metformin monotherapy: Results of a Phase IV open-label randomized controlled study (the SMART study).

PubMed

Du, Jin; Liang, Li; Fang, Hui; Xu, Fengmei; Li, Wei; Shen, Liya; Wang, Xueying; Xu, Chun; Bian, Fang; Mu, Yiming

2017-11-01

To investigate the efficacy, safety and tolerability of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. SMART was a 24-week, multicentre, randomized, parallel-group, open-label Phase IV study conducted at 35 sites in China (September 24, 2014 to September 29, 2015). The primary outcome was absolute change from baseline in HbA1c at Week 24. Secondary outcomes assessed at Week 24 included the proportion of patients achieving HbA1c < 7.0%, the proportion of patients with gastrointestinal adverse events (GI AEs), and the proportion of patients achieving HbA1c < 7.0% without GI AEs. Safety and tolerability were also assessed in all patients who received ≥1 dose of study medication. Four-hundred and eighty-eight patients were randomized (1:1) to saxagliptin or acarbose via a central randomization system (interactive voice/web response system); 241 and 244 patients received saxagliptin and acarbose, respectively, and 238 and 243 of these had ≥1 pre- and ≥1 post-baseline efficacy values recorded. Saxagliptin was non-inferior to acarbose for glycaemic control [Week 24 HbA1c change: -0.82% and -0.78%, respectively; difference (95% confidence interval): -0.04 (-0.22, 0.13)%], with similar proportions of patients in both treatment groups achieving HbA1c < 7.0%. However, fewer GI AEs were reported with saxagliptin compared with acarbose, and a greater number of patients who received saxagliptin achieved HbA1c < 7.0% without GI AEs compared with those receiving acarbose. Both therapies had similar efficacy profiles. However, saxagliptin was associated with fewer GI AEs, suggesting it might be preferential for clinical practice. NCT02243176, clinicaltrials.gov. © 2017 John Wiley & Sons Ltd.

A Novel Strategy for Continuation ECT in Geriatric Depression: Phase 2 of the PRIDE Study.

PubMed

Kellner, Charles H; Husain, Mustafa M; Knapp, Rebecca G; McCall, W Vaughn; Petrides, Georgios; Rudorfer, Matthew V; Young, Robert C; Sampson, Shirlene; McClintock, Shawn M; Mueller, Martina; Prudic, Joan; Greenberg, Robert M; Weiner, Richard D; Bailine, Samuel H; Rosenquist, Peter B; Raza, Ahmad; Kaliora, Styliani; Latoussakis, Vassilios; Tobias, Kristen G; Briggs, Mimi C; Liebman, Lauren S; Geduldig, Emma T; Teklehaimanot, Abeba A; Dooley, Mary; Lisanby, Sarah H

2016-11-01

The randomized phase (phase 2) of the Prolonging Remission in Depressed Elderly (PRIDE) study evaluated the efficacy and tolerability of continuation ECT plus medication compared with medication alone in depressed geriatric patients after a successful course of ECT (phase 1). PRIDE was a two-phase multisite study. Phase 1 was an acute course of right unilateral ultrabrief pulse ECT, augmented with venlafaxine. Phase 2 compared two randomized treatment arms: a medication only arm (venlafaxine plus lithium, over 24 weeks) and an ECT plus medication arm (four continuation ECT treatments over 1 month, plus additional ECT as needed, using the Symptom-Titrated, Algorithm-Based Longitudinal ECT [STABLE] algorithm, while continuing venlafaxine plus lithium). The intent-to-treat sample comprised 120 remitters from phase 1. The primary efficacy outcome measure was score on the 24-item Hamilton Depression Rating Scale (HAM-D), and the secondary efficacy outcome was score on the Clinical Global Impressions severity scale (CGI-S). Tolerability as measured by neurocognitive performance (reported elsewhere) was assessed using an extensive test battery; global cognitive functioning as assessed by the Mini-Mental State Examination (MMSE) is reported here. Longitudinal mixed-effects repeated-measures modeling was used to compare ECT plus medication and medication alone for efficacy and global cognitive function outcomes. At 24 weeks, the ECT plus medication group had statistically significantly lower HAM-D scores than the medication only group. The difference in adjusted mean HAM-D scores at study end was 4.2 (95% CI=1.6, 6.9). Significantly more patients in the ECT plus medication group were rated "not ill at all" on the CGI-S compared with the medication only group. There was no statistically significant difference between groups in MMSE score. Additional ECT after remission (here operationalized as four continuation ECT treatments followed by further ECT only as needed) was beneficial in sustaining mood improvement for most patients.

Efficacy and Tolerability of Two Different Kinds of Titration of Paroxetine Hydrocloride Solution: an Observational Study.

PubMed

Ielmini, Marta; Poloni, Nicola; Caselli, Ivano; Bianchi, Lucia; Diurni, Marcello; Vender, Simone; Callegari, Camilla

2018-03-13

Depressive disorders are expected to be the second highest cause of morbidity in the world until few years. Moreover, patients with depression frequently show many side effects and low compliance to therapy. To find a more tolerated and more efficacy therapy is a growing need. This observational study investigates the efficacy, safety and tolerability of paroxetine hydrochloride comparing slow versus standard titration in a population affected by Depressive Disoders (according to DSM 5). 186 outpatients were assessed throught the following scales: Hamilton Depression Rating Scale (HDRS) for depression and World Health Organization Quality of Life Scale Bref for the perceived quality of life (WHOQOL BREF). Treatment-emerged Adverse Events (TEAEs) were recorded throught self-reports. Statystical analysys was performed by GraphPad Prism Version 5.1. The efficacy of paroxetine was confirmed in both titrations by the number of clinical remitters (HDRS ≤ 7 at 12 weeks for 53% of the standard titration group and 58% of the slow titration group), without differences. About safety and tolerability there were more frequent TEAEs among the standard titration group (p < 0.01). Comparing WHOQOL BREF between the two groups at the recruitment and at the twelth week emerged a statistically significant difference (p = 0.003), with highest scores reached in slow titration group. Although the short observation period is an evident limit, this study is consistent to the literature about the efficacy of both titrations of paroxetine to improve depression and shows promising results about the increased tolerability of paroxetine slow titration.

Oral Antibacterial Therapy for Acne Vulgaris: An Evidence-Based Review.

PubMed

Bienenfeld, Amanda; Nagler, Arielle R; Orlow, Seth J

2017-08-01

To some degree, acne vulgaris affects nearly every individual worldwide. Oral antibiotic therapy is routinely prescribed for the treatment of moderate to severe inflammatory acne; however, long-term use of oral antibiotics for acne may have unintended consequences. The aim of this study was to provide a systematic evaluation of the scientific evidence on the efficacy and appropriate use of oral antibiotics in the treatment of acne. A systematic search of MEDLINE was conducted to identify randomized controlled clinical trials, systematic reviews, and meta-analyses evaluating the efficacy of oral antibiotics for acne. Overall, 41 articles that examined oral antibiotics compared with placebo, another oral therapy, topical therapy, alternate dose, or duration were included in this study. Tetracyclines, macrolides, and trimethoprim/sulfamethoxazole are effective and safe in the treatment of moderate to severe inflammatory acne. Superior efficacy of one type or class of antibiotic could not be determined, therefore the choice of antibiotic is generally based on the side-effect profile. Although different dosing regimens have been studied, there is a lack of standardized comparator trials to determine optimal dosing and duration of each oral antibiotic used in acne. The combination of oral antibiotics with a topical therapy is superior to oral antibiotics alone. This article provides a systematic evaluation of the scientific evidence of the efficacy of oral antibiotics for acne. Due to heterogeneity in the design of the trials, there is insufficient evidence to support one type, dose, or duration of oral antibiotic over another in terms of efficacy; however, due to increasing resistance to antibiotics, dermatologists should heed consensus guidelines for their appropriate use.

Combination of glycolic acid peel and topical 20% azelaic acid cream in melasma patients: efficacy and improvement in quality of life.

PubMed

Dayal, Surabhi; Sahu, Priyadarshini; Dua, Ruchika

2017-03-01

Glycolic acid (GA) peel is one of the most versatile agents in the treatment of melasma. GA peeling alone or in combination with topical hypopigmenting agents has shown encouraging results. However, there is paucity of controlled trial demonstrating the efficacy of glycolic peel in conjunction with topical azelaic acid (AA). We therefore sought to highlight the efficacy and safety of this combination in melasma. To assess the clinical efficacy, safety and reduction in melasma quality of life (MELASQOL) scores on combining serial GA peels with topical 20% AA cream in epidermal melasma. Sixty patients of epidermal melasma were enrolled for 24 weeks. Patients were divided into two groups: (1) Study group received serial GA peel every 3 weeks with twice daily 20% AA cream, and (2) control group received only 20% AA cream. Clinical improvement was assessed objectively using Melasma Area Severity Index (MASI). Melasma-related quality of life was measured by MELASQOL scale in both groups. Side effects were observed at each visit. The improvement in MASI and percentage decrease in MASI scoring were statistically significant 12 weeks onwards in study group as compared to control group. There was also a significant reduction in MELASQOL scores in study group as compared to control group after treatment. Minor reversible side effects were observed in both groups, which did not require cessation of therapy. GA peel enhances therapeutic efficacy of topical AA cream for treatment of melasma, with improvement in quality of life without serious side effects. © 2016 Wiley Periodicals, Inc.

Faster onset of antidepressant effects of citalopram compared with sertraline in drug-naïve first-episode major depressive disorder in a Chinese population: a 6-week double-blind, randomized comparative study.

PubMed

Hsu, Ju-Wei; Su, Tung-Ping; Huang, Chen-Ying; Chen, Ying-Sheue; Chou, Yuan-Hwa

2011-10-01

Several previous studies, including a meta-analysis, reported no significant differences between various selective serotonin reuptake inhibitors (SSRIs) in the treatment of major depressive disorder. However, because of the different chemical structure of SSRIs and the difference in the frequency of serotonin transporter polymorphisms between ethnic groups, a head-to-head comparative study between SSRIs in different populations may be enlightening. We compared the efficacy and adverse effect profiles of citalopram and sertraline in a double-blinded randomized clinical trial in a Chinese population of drug-naïve patients with first-episode major depressive disorder. Fifty-one patients were randomly assigned to citalopram or sertraline treatment. The Montgomery-Åsberg Depression Rating Scale (MADRS) was used as the primary outcome. Efficacy and adverse effects were analyzed in an intent-to-treat population. Efficacy was analyzed using a last-observation-carried-forward method for early terminators. There were no significant differences in demographic characteristics at baseline. No significant differences were found in MADRS scores between citalopram and sertraline at baseline (36.6 ± 5.5 vs 38.2 ± 4.9; P = 0.322) or at the end of treatment (week 6; 10.8 ± 10.0 vs 16.7 ± 11.3; P = 0.082). However, MADRS scores in the citalopram group were significantly lower at week 1 (25.2 ± 8.5 vs 30.4 ± 6.1; P = 0.029) and week 3 (15.9 ± 10.0 vs 22.1 ± 8.7; P = 0.037). Overall, treatment-emergent adverse effects were reported by 14.3% and 28.6% of patients in the citalopram and sertraline groups, respectively. In conclusion, citalopram and sertraline were both efficacious and well tolerated. However, citalopram exhibited a significantly faster onset than sertraline during the early weeks of treatment and tended to have a better efficacy in overall treatment, although the statistic was not significant.

The Relationship between Falls Efficacy and Improvement in Fall Risk Factors Following an Exercise Plus Educational Intervention for Older Adults with Hip Osteoarthritis.

PubMed

Arnold, C M; Faulkner, R A; Gyurcsik, N C

2011-01-01

Older adults with decreased confidence in their ability to prevent a fall may benefit from an exercise programme that includes self-efficacy-enhancing education. The objectives of this study were to explore differences in fall-risk outcomes in older adults with higher vs. lower levels of falls efficacy and to evaluate the relationship between baseline falls-efficacy status and changes in fall risk factors following two interventions. Fifty-four older adults with hip osteoarthritis and at least one risk factor for falls received aquatic exercise twice weekly plus education once weekly (EE) or aquatic exercise only, twice weekly (EO), for 11 weeks. EE participants with low baseline falls efficacy demonstrated significantly (p<0.05) greater improvement in balance and falls efficacy compared to EE participants with high baseline falls efficacy. In the EE group only, baseline falls-efficacy status (low vs. high median split on the Activities-specific Balance Confidence Scale) was significantly (p<0.05) correlated with positive balance and falls-efficacy change scores (Spearman rank r=0.45 and 0.63 respectively). Individuals with one or more fall-risk factors and low falls efficacy may benefit from receiving an intervention that combines exercise with self-efficacy-enhancing education. Falls-efficacy screening may be important for decisions regarding referral to fall-prevention programmes.

The Relationship between Falls Efficacy and Improvement in Fall Risk Factors Following an Exercise Plus Educational Intervention for Older Adults with Hip Osteoarthritis

PubMed Central

Faulkner, R.A.; Gyurcsik, N.C.

2011-01-01

ABSTRACT Purpose: Older adults with decreased confidence in their ability to prevent a fall may benefit from an exercise programme that includes self-efficacy-enhancing education. The objectives of this study were to explore differences in fall-risk outcomes in older adults with higher vs. lower levels of falls efficacy and to evaluate the relationship between baseline falls-efficacy status and changes in fall risk factors following two interventions. Method: Fifty-four older adults with hip osteoarthritis and at least one risk factor for falls received aquatic exercise twice weekly plus education once weekly (EE) or aquatic exercise only, twice weekly (EO), for 11 weeks. Results: EE participants with low baseline falls efficacy demonstrated significantly (p<0.05) greater improvement in balance and falls efficacy compared to EE participants with high baseline falls efficacy. In the EE group only, baseline falls-efficacy status (low vs. high median split on the Activities-specific Balance Confidence Scale) was significantly (p<0.05) correlated with positive balance and falls-efficacy change scores (Spearman rank r=0.45 and 0.63 respectively). Conclusions: Individuals with one or more fall-risk factors and low falls efficacy may benefit from receiving an intervention that combines exercise with self-efficacy-enhancing education. Falls-efficacy screening may be important for decisions regarding referral to fall-prevention programmes. PMID:22942514

Antibiotics for the neurological complications of Lyme disease.

PubMed

Cadavid, Diego; Auwaerter, Paul G; Rumbaugh, Jeffrey; Gelderblom, Harald

2016-12-08

Various central nervous system-penetrant antibiotics are bactericidal in vitro and in vivo against the causative agent of Lyme neuroborreliosis (LNB), Borrelia burgdorferi. These antibiotics are routinely used clinically to treat LNB, but their relative efficacy is not clear. To assess the effects of antibiotics for the treatment of LNB. On 25 October 2016 we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase. We searched clinical trial registers on 26 October 2016. We reviewed the bibliographies of the randomized trials identified and contacted the authors and known experts in the field to identify additional published or unpublished data. There were no language restrictions when searching for studies. Randomized clinical trials of antibiotic treatment of LNB in adults and children that compared any antibiotic treatment, including combinations of treatments, versus any other treatment, placebo, or no treatment. We excluded studies of entities considered as post-Lyme syndrome. We used standard methodological procedures expected by Cochrane. We identified seven randomized studies involving 450 European participants with LNB for inclusion in this systematic review. We found no trials conducted in the United States. Marked heterogeneity among these studies prevented meta-analysis. None of the studies included a placebo control on the initial antibiotic treatment, and only one was blinded. None were delayed-start studies. All were active comparator studies, and most were not adequately powered for non-inferiority comparison. The trials investigated four antibiotics: penicillin G and ceftriaxone in four studies, doxycycline in three studies, and cefotaxime in two studies. One study tested a three-month course of oral amoxicillin versus placebo following initial treatment with intravenous ceftriaxone. One study was limited to children. The trials measured efficacy using heterogeneous physician- or patient-reported outcomes, or both. In some cases cerebrospinal fluid analysis was included as an indirect biomarker of disease and outcome. None of the studies reported on our proposed primary outcome, 'Improvement in a measure of overall disability in the long term (three or more months).' None of the trials revealed any between-group differences in symptom resolution in response to active treatment. In general, treatment was tolerated well. The quality of adverse event reporting, however, was low. There is mostly low- to very low-quality clinical evidence from a limited number of mostly small, heterogeneous trials with diverse outcome measures, comparing the relative efficacy of central nervous system-penetrant antibiotics for the treatment of LNB. The few existing randomized studies have limited power and lack consistent and well-defined entry criteria and efficacy endpoints. It is not possible to draw firm conclusions on the relative efficacy of accepted antibiotic drug regimens for the treatment of LNB. The majority of people are reported to have good outcomes, and symptoms resolve by 12 months regardless of the antibiotic used. A minority of participants did not improve sufficiently, and some were retreated. These randomized studies provide some evidence that doxycycline, penicillin G, ceftriaxone, and cefotaxime are efficacious in the treatment of European LNB. No evidence of additional efficacy was observed when, in one study, an initial antibiotic treatment with intravenous ceftriaxone was followed by additional longer treatment with oral amoxicillin. There is a lack of evidence identified through our high-quality search strategy on the efficacy of antibiotics for treatment of LNB in the United States.

Moxifloxacin in Pediatric Patients with Complicated Intra-Abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study.

PubMed

Wirth, Stefan; Emil, Sherif G S; Engelis, Arnis; Digtyar, Valeri; Criollo, Margarita; DiCasoli, Carl; Stass, Heino; Willmann, Stefan; Nkulikiyinka, Richard; Grossmann, Ulrike

2018-01-18

This study was designed to evaluate primarily the safety and also the efficacy of moxifloxacin (MXF) in children with complicated intra-abdominal infections (cIAIs). In this multicenter, randomized, double-blind, controlled study, 451 pediatric patients aged 3 months to 17 years with cIAIs were treated with intravenous/oral MXF (N = 301) or comparator (COMP, intravenous ertapenem followed by oral amoxicillin/clavulanate; N = 150) for 5 to 14 days. Doses of MXF were selected based on the results of a Phase 1 study in pediatric patients (NCT01049022). The primary endpoint was safety, with particular focus on cardiac and musculoskeletal safety; clinical and bacteriological efficacy at test of cure were also investigated. The proportion of patients with adverse events (AEs) was comparable between the two treatment arms (MXF: 58.1% and COMP: 54.7%). The incidence of drug-related AEs was higher in the MXF arm than the COMP arm (14.3% and 6.7%, respectively). No cases of QTc interval prolongation-related morbidity or mortality were observed. The proportion of patients with musculoskeletal AEs was comparable between treatment arms; no drug-related events were reported. Clinical cure rates were 84.6% and 95.5% in the MXF and COMP arms, respectively, in patients with confirmed pathogen(s) at baseline. MXF treatment was well tolerated in children with cIAIs. However, a lower clinical cure rate was observed with MXF treatment compared with COMP. This study does not support a recommendation of MXF for children with cIAIs when alternative more efficacious antibiotics with better safety profile are available.

The efficacy and adverse effects of in vitro fertilization and embryo transfer.

PubMed

Corabian, P; Hailey, D

1999-01-01

This paper examines the current status of in vitro fertilization and embryo transfer (IVF-ET) as a treatment for various types of infertility. We reviewed studies on the efficacy and safety of IVF-ET and intracytoplasmic sperm injection (ICSI) plus IVF-ET, compared with conventional treatment or no treatment for various infertility diagnoses. Material retrieved included English language publications between 1992 and January 1997 that reported the results of prospective controlled clinical trials, cohort studies, and retrospective comparative studies with large series, and reviews presenting risks, complications, and longer-term health consequences associated with IVF-ET and ICSI. No adequate prospective comparative studies of sufficient power on the use of IVF-ET for specific infertility diagnoses have been reported to date. Most of the published reports concerning results with IVF-ET as a treatment of infertility have been based upon small, uncontrolled studies, with various methodological weaknesses. Reported results are not directly comparable. There are few follow-up data on outcomes after pregnancy is established or on long-term health consequences of the use of IVF-ET on mothers and their babies. IVF-ET has diffused widely without comprehensive assessment of its efficacy and safety. The available evidence supports its use only for severe bilateral tubal occlusion. For other diagnoses of infertility the evidence is limited and does not establish whether IVF-ET is effective. Long-term, well-designed, prospective clinical trials are required to determine when and for what indications IVF-ET is effective and what its health effects are on both mothers and their babies.

A comparison of fathers' and mothers' contributions in the prediction of academic performance of school-age children in Hong Kong.

PubMed

Tam, Vicky C W

2009-04-01

Asystematic study of the linkages between gender issues and parenting is made among Chinese families. This study examines sex differences in parenting attributes across fathers and mothers and towards sons and daughters, and compares the contributions of fathers and mothers to the prediction of academic performance across boys and girls. Four parenting attributes are included: nurturance, psychological control, parental involvement in education, and parental academic efficacy. Data were collected from 461 Chinese father-mother-child triads of children studying Grade 3 to 5 in Hong Kong. Findings of this study, based on multivariate analysis of variance, showed that parental roles followed traditional Chinese cultural expectations. Compared to the fathers, Chinese mothers of school-age children in Hong Kong were more loving and caring, more involved in children's education, and more efficacious in promoting children's academic performance. Results of hierarchical regression analysis examining the role of child's sex as a moderator showed cross-sex influence in parental contribution to academic performance with respect to parental psychological control and academic efficacy. Specifically, boys benefited more from maternal efficacy than girls did and they were also more hampered by mothers with high psychological control, while girls' academic performance was more enhanced by paternal academic efficacy than boys. A gender-balance approach that highlights the significance of gender in moderating parental contributions to academic performance was thus supported. Future research should continue to focus on psychological control and domain-specific parental attributes as potential sources of gender-linked parent-child associations. Investigations should also explore other cognitive and noncognitive domains of child outcome, different child age groups, as well as Chinese populations in various geographical regions.

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

PubMed

Solomon, James A; Tyring, Stephen; Staedtler, Gerald; Sand, Meike; Nkulikiyinka, Richard; Shakery, Kaweh

2016-09-01

Papulopustular rosacea (PPR) is characterized by centrofacial papules and pustules commonly associated with erythema. To compare investigator-reported efficacy outcomes for azelaic acid (AzA) foam 15% versus vehicle foam in PPR, a randomized, vehicle-controlled, double-blind phase 3 clinical trial was conducted at 48 US sites. Participants received AzA foam or vehicle foam for 12 weeks. Secondary efficacy outcomes included change in inflammatory lesion count (ILC), therapeutic response rate according to investigator global assessment (IGA), and change in erythema rating. This study was comprised of 961 participants with PPR. The results support the therapeutic superiority of AzA foam over vehicle foam.

Chlorhexidine hexametaphosphate as a wound care material coating: antimicrobial efficacy, toxicity and effect on healing.

PubMed

Barbour, Michele E; Maddocks, Sarah E; Grady, Helena J; Roper, James A; Bass, Mark D; Collins, Andrew M; Dommett, Rachel M; Saunders, Margaret

2016-08-01

In this study, chlorhexidine hexametaphosphate (CHX-HMP) is investigated as a persistent antimicrobial coating for wound care materials. CHX-HMP was used as a wound care material coating and compared with chlorhexidine digluconate materials with respect to antimicrobial efficacy, toxicity and wound closure. Antimicrobial efficacy at day 1, 3 and 7 was observed with experimental and commercial materials. CHX-HMP coated materials had less toxic effect on human placental cells than commercial chlorhexidine dressings. CHX-HMP in pluronic gel did not delay healing but reduced wound colonization by E. faecalis. CHX-HMP could become a useful component of wound care materials with sustained antimicrobial efficacy, lower toxicity than chlorhexidine digluconate materials, and reduction in wound colonization without affecting closure.

The relationship between childbirth self-efficacy and aspects of well-being, birth interventions and birth outcomes.

PubMed

Carlsson, Ing-Marie; Ziegert, Kristina; Nissen, Eva

2015-10-01

this study aimed to examine how women׳s childbirth self-efficacy beliefs relate to aspects of well-being during the third trimester of pregnancy and whether there was any association between childbirth self-efficacy and obstetric factors. a cross-sectional design was used. The data was obtained through the distribution of a composite questionnaire and antenatal and birth records. data were recruited from antenatal health-care clinics in Halland, Sweden. a consecutive sample of 406 pregnant women was recruited at the end of pregnancy at gestational weeks of 35-42. five different measures were used; the Swedish version of Childbirth Self-Efficacy Inventory, the Wijma Delivery Expectancy/Experience Questionnaire, the Sense of Coherence Questionnaire, the Maternity Social Support Scale and finally the Profile of Mood States. results showed that childbirth self-efficacy was correlated with positive dimensions as vigour, sense of coherence and maternal support and negatively correlated with previous mental illness, negative mood states and fear of childbirth. Women who reported high childbirth self-efficacy had less epidural analgesia during childbirth, compared to women with low self-efficacy. this study highlights that childbirth self-efficacy is a positive dimension that interplays with other aspects and contributes to well-being during pregnancy and thereby, acts as an asset in the context of childbirth. Copyright © 2015 Elsevier Ltd. All rights reserved.

Aging perceptions and self-efficacy mediate the association between personality traits and depressive symptoms in older adults.

PubMed

O'Shea, D M; Dotson, V M; Fieo, R A

2017-12-01

Personality traits have been shown to be predictors of depressive symptoms in late life. Thus, we examined whether other more modifiable sources of individual differences such as self-efficacy and self-perceptions of aging would mediate the association between personality traits and depressive symptoms in older adults. Data were obtained from 3,507 older adult participants who took part in the 2012 Health and Retirement Study. The "Big Five" personality traits, self-efficacy, aging perceptions, and depressive symptoms were assessed. Mediation analyses tested the hypothesis that self-efficacy and aging perceptions would mediate the relationship between personality traits and depressive symptoms. All five personality traits were significant predictors of depressive symptoms. Neuroticism was positively associated with depressive symptoms and had the greatest effect compared with the other personality traits. There was a significant indirect effect of neuroticism, extraversion, and conscientiousness on depressive symptoms (including both mediators). The mediating effect of aging perceptions on the relationship between neuroticism and depressive symptoms was the strongest compared with self-efficacy, accounting for approximately 80% of the total indirect effect. Our results provide support for interventions aimed at improving self-perceptions related to efficacy and aging in order to reduce depressive symptoms in older adults. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Preclinical safety and efficacy of a new recombinant FIX drug product for treatment of hemophilia B.

PubMed

Dietrich, Barbara; Schiviz, Alexandra; Hoellriegl, Werner; Horling, Frank; Benamara, Karima; Rottensteiner, Hanspeter; Turecek, Peter L; Schwarz, Hans Peter; Scheiflinger, Friedrich; Muchitsch, Eva-Maria

2013-11-01

Baxter has developed a new recombinant factor IX (rFIX) drug product (BAX326) for treating patients with hemophilia B, or congenital FIX deficiency. An extensive preclinical program evaluated the pharmacokinetics, efficacy, and safety of BAX326 in different species. The efficacy of BAX326 was tested in three mouse models of primary pharmacodynamics: tail-tip bleeding, carotid occlusion, and thrombelastography. The pharmacokinetics was evaluated after a single intravenous bolus injection in mice, rats, and macaques. Toxicity was assessed in rats and macaques, safety pharmacology in rabbits and macaques, and immunogenicity in mice. BAX326 was shown to be efficacious in all three primary pharmacodynamic studies (P ≤ 0.0076). Hemostatic efficacy was dose related and similar for the three lots tested. Pharmacokinetic results showed that rFIX activity and rFIX antigen concentrations declined in a bi-phasic manner, similar to a previously licensed rFIX product. BAX326 was well tolerated in rabbits and macaques at all dose levels; no thrombogenic events and no adverse clinical, respiratory, or cardiovascular effects occurred. BAX326 was also shown to have a similar immunogenicity profile to the comparator rFIX product in mice. These results demonstrate that BAX326 has a favorable preclinical safety and efficacy profile, predictive of a comparable effect to that of the previously licensed rFIX in humans.

The role of risk, efficacy, and anxiety in smokers' cancer information seeking.

PubMed

Zhao, Xiaoquan; Cai, Xiaomei

2009-04-01

Using the risk perception attitude (RPA) framework and the 2005 Health Information National Trends Survey data, this research investigated the role of perceived personal risk, perceived comparative risk, response efficacy, communication efficacy, and anxiety in smokers' active cancer information seeking. The RPA predictions on the interactions between perceived personal risk and the two efficacy measures were not supported. Perceived personal risk and response efficacy were associated with cancer information seeking both directly and through the mediation of anxiety. Optimistic comparative risk perceptions were associated with less anxiety and were found to moderate the relationship between perceived personal risk and cancer information seeking. Surprisingly, communication efficacy emerged as a negative predictor of cancer information seeking. Theoretical and practical implications of these findings are discussed.

Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.

PubMed

Wang, Yongjun; Parker, Claire E; Bhanji, Tania; Feagan, Brian G; MacDonald, John K

2016-04-21

Oral 5-aminosalicylic acid (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. Previously, it was found that 5-ASA drugs in doses of at least 2 g/day, were more effective than placebo but no more effective than SASP for inducing remission in ulcerative colitis. This updated review includes more recent studies and evaluates the efficacy and safety of 5-ASA preparations used for the treatment of mild to moderately active ulcerative colitis. The primary objectives were to assess the efficacy, dose-responsiveness and safety of oral 5-ASA compared to placebo, SASP, or 5-ASA comparators for induction of remission in active ulcerative colitis. A secondary objective of this systematic review was to compare the efficacy and safety of once daily dosing of oral 5-ASA with conventional (two or three times daily) dosing regimens. A computer-assisted literature search for relevant studies (inception to July 9, 2015) was performed using MEDLINE, EMBASE and the Cochrane Library. Review articles and conference proceedings were also searched to identify additional studies. Studies were accepted for analysis if they were randomized controlled clinical trials of parallel design, with a minimum treatment duration of four weeks. Studies of oral 5-ASA therapy for treatment of patients with active ulcerative colitis compared with placebo, SASP or other formulations of 5-ASA were considered for inclusion. Studies that compared once daily 5-ASA treatment with conventional dosing of 5-ASA (two or three times daily) and 5-ASA dose ranging studies were also considered for inclusion. The outcomes of interest were the failure to induce global/clinical remission, global/clinical improvement, endoscopic remission, endoscopic improvement, adherence, adverse events, withdrawals due to adverse events, and withdrawals or exclusions after entry. Trials were separated into five comparison groups: 5-ASA versus placebo, 5-ASA versus sulfasalazine, once daily dosing versus conventional dosing, 5-ASA versus comparator 5-ASA, and 5-ASA dose-ranging. Placebo-controlled trials were subgrouped by dosage. SASP-controlled trials were subgrouped by 5-ASA/SASP mass ratios. Once daily versus conventional dosing studies were subgrouped by formulation. 5-ASA-controlled trials were subgrouped by common 5-ASA comparators (e.g. Asacol, Claversal, Salofalk and Pentasa). Dose-ranging studies were subgrouped by 5-ASA formulation. We calculated the relative risk (RR) and 95% confidence intervals (95% CI) for each outcome. Data were analyzed on an intention-to-treat basis. Fifty-three studies (8548 patients) were included. The majority of included studies were rated as low risk of bias. 5-ASA was significantly superior to placebo with regard to all measured outcome variables. Seventy-one per cent of 5-ASA patients failed to enter clinical remission compared to 83% of placebo patients (RR 0.86, 95% CI 0.82 to 0.89). A dose-response trend for 5-ASA was also observed. No statistically significant differences in efficacy were found between 5-ASA and SASP. Fifty-four per cent of 5-ASA patients failed to enter remission compared to 58% of SASP patients (RR 0.90, 95% CI 0.77 to 1.04). No statistically significant differences in efficacy or adherence were found between once daily and conventionally dosed 5-ASA. Forty-five per cent of once daily patients failed to enter clinical remission compared to 48% of conventionally dosed patients (RR 0.94, 95% CI 0.83 to 1.07). Eight per cent of patients dosed once daily failed to adhere to their medication regimen compared to 6% of conventionally dosed patients (RR 1.36, 95% CI 0.64 to 2.86). There does not appear to be any difference in efficacy among the various 5-ASA formulations. Fifty per cent of patients in the 5-ASA group failed to enter remission compared to 52% of patients in the 5-ASA comparator group (RR 0.94, 95% CI 0.86 to 1.02). A pooled analysis of 3 studies (n = 1459 patients) studies found no statistically significant difference in clinical improvement between Asacol 4.8 g/day and 2.4 g/day used for the treatment of moderately active ulcerative colitis. Thirty-seven per cent of patients in the 4.8 g/day group failed to improve clinically compared to 41% of patients in the 2.4 g/day group (RR 0.89; 95% CI 0.78 to 1.01). Subgroup analysis indicated that patients with moderate disease may benefit from the higher dose of 4.8 g/day. One study compared (n = 123 patients) Pentasa 4 g/day to 2.25 g/day in patients with moderate disease. Twenty-five per cent of patients in the 4 g/day group failed to improve clinically compared to 57% of patients in the 2.25 g/day group (RR 0.44; 95% CI 0.27 to 0.71). A pooled analysis of two studies comparing MMX mesalamine 4.8 g/day to 2.4 g/day found no statistically significant difference in efficacy (RR 1.03, 95% CI 0.82 to 1.29). There were no statistically significant differences in the incidence of adverse events between 5-ASA and placebo, once daily and conventionally dosed 5-ASA, 5-ASA and comparator 5-ASA formulation and 5-ASA dose ranging (high dose versus low dose) studies. Common adverse events included flatulence, abdominal pain, nausea, diarrhea, headache and worsening ulcerative colitis. SASP was not as well tolerated as 5-ASA. Twenty-nine percent of SASP patients experienced an adverse event compared to 15% of 5-ASA patients (RR 0.48, 95% CI 0.37 to 0.63). 5-ASA was superior to placebo and no more effective than SASP. Considering their relative costs, a clinical advantage to using oral 5-ASA in place of SASP appears unlikely. 5-ASA dosed once daily appears to be as efficacious and safe as conventionally dosed 5-ASA. Adherence does not appear to be enhanced by once daily dosing in the clinical trial setting. It is unknown if once daily dosing of 5-ASA improves adherence in a community-based setting. There do not appear to be any differences in efficacy or safety among the various 5-ASA formulations. A daily dosage of 2.4 g appears to be a safe and effective induction therapy for patients with mild to moderately active ulcerative colitis. Patients with moderate disease may benefit from an initial dose of 4.8 g/day.

U.S.-born compared to non-U.S.-born abused women: analysis of baseline data.

PubMed

Montalvo-Liendo, Nora; Koci, Anne; McFarlane, Judith; Gilroy, Heidi; Maddoux, John

2013-01-01

It is evident from recent studies that a woman's citizenship status does not exempt her from exposure to partner violence. The purpose of this article was to examine if social support, self-efficacy, and marginalization of abused women differ based on U.S. born compared to non-U.S. born with and without documentation. The findings suggest that women who were born in the United States had significantly higher self-efficacy scores compared to non-U.S.-born women without documents. There were no significant differences in social support among abused women who are U.S. born compared to non-U.S. born with and without documentation. In addition, women who were not born in the United States and did not have documents had higher marginalization.

In vitro antifungal efficacy of ciclopirox olamine alone and associated with zinc pyrithione compared to ketoconazole against Malassezia globosa and Malassezia restricta reference strains.

PubMed

Roques, Christine; Brousse, Sabine; Panizzutti, Cédric

2006-12-01

The aim of this study was to determine the in vitro fungicidal and growth inhibitory activity of ciclopirox olamine alone (1% and 1.5%) or in association with 1% zinc pyrithione compared to 2% ketoconazole, against Malassezia species particularly involved in the pathogenesis of seborrheic dermatitis. Experiments were performed on Malassezia globosa IP 2387.96 and M. restricta IP 2392.96 strains. Growth inhibitory activity of the active compounds in solution was evaluated by measuring minimal inhibitory concentrations using a broth micro-method and their fungicidal activity by a filtration method after contact times between solutions and yeasts ranging from 3-5 to 30 min. Concerning the determination of minimal inhibitory concentration of ciclopirox olamine/zinc pyrithione, it revealed the marked synergistic inhibitory effect of the association, leading to a higher efficacy compared to ketoconazole. As to the fungicidal activity of ciclopirox olamine, it significantly increased with the contact time. After 15-30 min of contact between 1.5% ciclopirox olamine and Malassezia strains, a 2-log reduction of Malassezia counts was observed. The 1.5% ciclopirox olamine/1% zinc pyrithione association was characterized by a steady fungicidal efficacy whereas the 2% ketoconazole solution did not express any fungicidal effect. In conclusion, this study demonstrates the in vitro inhibitory and fungicidal efficacy of the ciclopirox olamine/zinc pyrithione association against Malassezia species and underscores its potential interest in the treatment of seborrheic dermatitis.

Efinaconazole Topical Solution, 10%: Efficacy in Patients with Onychomycosis and Coexisting Tinea Pedis.

PubMed

Markinson, Bryan C; Caldwell, Bryan D

2015-04-13

We sought to evaluate the efficacy of efinaconazole topical solution, 10%, in patients with onychomycosis and coexisting tinea pedis. We analyzed 1,655 patients, aged 18 to 70 years, randomized (3:1) to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of the target toenail and negative potassium hydroxide examination and fungal culture findings) at week 52. Three groups were compared: patients with onychomycosis and coexisting interdigital tinea pedis on-study (treated or left untreated) and those with no coexisting tinea pedis. Treatment with efinaconazole topical solution, 10%, was significantly more effective than vehicle use irrespective of the coexistence of tinea pedis or its treatment. Overall, 352 patients with onychomycosis (21.3%) had coexisting interdigital tinea pedis at baseline, with 215 of these patients (61.1%) receiving investigator-approved topical antifungal agents for their tinea pedis in addition to their randomized onychomycosis treatment. At week 52, efinaconazole complete cure rates of 29.4% were reported in patients with onychomycosis when coexisting tinea pedis was treated compared with 16.1% when coexisting tinea pedis was not treated. Both cure rates were significant compared with vehicle (P = .003 and .045, respectively), and in the latter subgroup, no patients treated with vehicle achieved a complete cure. Treatment of coexisting tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.

Efinaconazole Topical Solution, 10% Efficacy in Patients with Onychomycosis and Coexisting Tinea Pedis.

PubMed

Markinson, Bryan; Caldwell, Bryan

2015-09-01

We sought to evaluate the efficacy of efinaconazole topical solution, 10%, in patients with onychomycosis and coexisting tinea pedis. We analyzed 1,655 patients, aged 18 to 70 years, randomized (3:1) to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of the target toenail and negative potassium hydroxide examination and fungal culture findings) at week 52. Three groups were compared: patients with onychomycosis and coexisting interdigital tinea pedis on-study (treated or left untreated) and those with no coexisting tinea pedis. Treatment with efinaconazole topical solution, 10%, was significantly more effective than vehicle use irrespective of the coexistence of tinea pedis or its treatment. Overall, 352 patients with onychomycosis (21.3%) had coexisting interdigital tinea pedis, with 215 of these patients (61.1%) receiving investigator-approved topical antifungal agents for their tinea pedis in addition to their randomized onychomycosis treatment. At week 52, efinaconazole complete cure rates of 29.4% were reported in patients with onychomycosis when coexisting tinea pedis was treated compared with 16.1% when coexisting tinea pedis was not treated. Both cure rates were significant compared with vehicle (P = .003 and .045, respectively), and in the latter subgroup, no patients treated with vehicle achieved a complete cure. Treatment of coexisting tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.

Hypofractionated radiation therapy for prostate cancer: biologic and technical considerations

PubMed Central

Sanfilippo, Nicholas J; Cooper, Benjamin T

2014-01-01

The optimal radiation schedule for the curative treatment of prostate cancer is not known. The dose-response of tumors and normal tissues to fractionated irradiation can be described according to a parameter called the alpha-beta ratio (α/β). In the past several years numerous reports have been published that suggest that the alpha-beta ratio for prostate cancer may be quite low; between 1 and 3. If this hypothesis is true, then a radiation therapy schedule that employs less frequent and larger fractions, termed hypofractionation, may be more efficacious. Multiple randomized trials have been conducted comparing moderate (less than 5 Gy/day) hypofractionated radiation therapy and standard radiation therapy in men with prostate cancer. In the majority of these studies the moderate hypofractionated arm had equivalent efficacy with a similar or improved side effect profile. One area to use caution may be in patients with compromised (IPSS > 12) urinary function at baseline due to an increase in urinary toxicity observed in patients treated with hypofractionated radiation in one study. Extreme hypofractionation (greater than or equal to 5 Gy/day), is currently being compared in a randomized trial. Early prospectively collected data from multiple institutions demonstrates efficacy and toxicity that compares favorably with historical controls. The cost savings from hypofractionation could be profound on a national level and only increases the necessity of testing hypofractionated treatment schedules. Long term data and future trials will help radiation oncologists determine the ideal fractionation scheme based on cost, efficacy, and toxicity. PMID:25606574

Ultrasound and Cadaveric Prosections as Methods for Teaching Cardiac Anatomy: A Comparative Study

ERIC Educational Resources Information Center

Griksaitis, Michael J.; Sawdon, Marina A.; Finn, Gabrielle M.

2012-01-01

This study compared the efficacy of two cardiac anatomy teaching modalities, ultrasound imaging and cadaveric prosections, for learning cardiac gross anatomy. One hundred and eight first-year medical students participated. Two weeks prior to the teaching intervention, students completed a pretest to assess their prior knowledge and to ensure that…

Recurrent achalasia treated with Heller myotomy: A review of the literature

PubMed Central

Wang, Lan; Li, You-Ming

2008-01-01

AIM: To evaluate the efficacy and safety of Heller myotomy (HM) for recurrent achalasia, performed after different methods of first-line treatment. METHODS: We searched for studies published in PubMed from 1966 to March 2008 on treatment of recurrent achalasia with HM after failure with different methods of first-line treatment. The efficacy of HM was assessed by a pooled estimate of response rate with individual studies weighted proportionally to sample size. RESULTS: Sixteen studies were eligible and included in the review. The results showed that HM has a better remission rate for recurrent achalasia after failure of HM [weighted mean (SD)] of 86.9% (21.8%) compared with 81.6% (23.8%) for pneumatic dilatation (PD). One study evaluated the efficacy of HM after failure of PD combined with botulinum toxin injection (83%). The most common complications were perforation and gastroesophageal reflux. CONCLUSION: HM has the best efficacy in patients with recurrent achalasia who were treated with HM as first-line treatment. Future studies should focus on how to increase the success rate and decrease the complications of HM. PMID:19084921

The promise of a better group future: Cognitive alternatives increase students' self-efficacy and academic performance.

PubMed

Iyer, Aarti; Zhang, Airong; Jetten, Jolanda; Hao, Zhen; Cui, Lijuan

2017-12-01

Drawing on classic social identity theorizing (Tajfel, Differentiation between social groups: Studies in the social psychology of intergroup relations, London, UK, Academic Press, 1978), we propose that low-status minority group members' self-efficacy and performance on intellectual tasks can be enhanced by prompting them to believe in a better future for their group (i.e., increasing awareness of cognitive alternatives to the existing low-status position). Study 1 manipulated cognitive alternatives among 157 migrant workers' children in China, showing that self-efficacy was enhanced in the high compared to the low cognitive alternative condition. Study 2 extended this experimental finding among 114 migrant workers' children: Participants in the high cognitive alternative condition performed better on mathematics and attention tasks than did participants in the low cognitive alternative condition. Results highlight the power of believing in a better future for the collective as a means of enhancing self-efficacy and educational outcomes among members of disadvantaged groups. © 2017 The British Psychological Society.

Antivenom therapy for snakebites in children: is there evidence?

PubMed

Schmidt, James M

2005-04-01

A new Fab fragment antivenom (CroFab) for the treatment of crotaline envenomation, the predominant venomous snakebite in the United States, has drastically changed snakebite management since its release in December 2000. This review examines the evidence supporting the use of CroFab, with particular attention on the pediatric population. The published experience with CroFab in humans consists of six studies and some case reports. These publications demonstrate that CroFab is highly efficacious in treating both the local and systemic toxic effects of crotaline envenomation. They identify an important phenomenon of recurrent or delayed toxicity in some patients. The studies report a very low incidence of acute or delayed hypersensitivity reactions to the antivenom. They suggest comparable efficacy and safety of CroFab in the pediatric population as in adults. Based on limited data, CroFab has been shown to be a safe and efficacious antivenom for use in children as well as adults. Further studies are needed to refine our understanding of its efficacy, safety, indications, and dosing.

The efficacy and safety of probiotics for prevention of chemoradiotherapy-induced diarrhea in people with abdominal and pelvic cancer: a systematic review and meta-analysis.

PubMed

Wang, Y-H; Yao, N; Wei, K-K; Jiang, L; Hanif, S; Wang, Z-X; Pei, C-X

2016-11-01

A systematic review and meta-analysis were designed to evaluate the efficacy and safety of probiotics for prevention of chemoradiotherapy-induced diarrhea in people with abdominal and pelvic cancer. We searched the Cochrane Library, PubMed, EMBASE and Web of Science up to November 2015. We also hand searched the citation lists of included studies and previously identified systematic reviews to identify further relevant trials. Odds ratio (OR) was used to compare efficacy, and the pooled OR was estimated using a random effects model; heterogeneity was assessed with Cochran's Q and the Higgins' I 2 -test. Two reviewers assessed trial quality and extracted data independently. Analysis and bias for each included study were performed using Review Manager 5.2. Nine randomized and placebo-controlled studies (N=1265 participants) were included for assessing efficacy, of which seven were about radiotherapy and two about chemotherapy. Probiotic groups were compared with control groups with respect to the the incidence of diarrhea, OR=0.47 (95% confidence interval 0.28-0.76; P=0.002). Eleven studies, including 1612 people (873 consuming probiotics and 739 not consuming probiotics), were used for the analysis of safety of probiotics. Of the 11 studies, seven studies had no adverse events (AEs) caused by probiotics, whereas four studies reported varying degrees of AEs in their treatment. Probiotics may have a beneficial effect in prevention of chemoradiotherapy-induced diarrhea generally, especially for Grade⩾2 diarrhea. Probiotics may rarely cause AEs.

[Multicenter study comparing the efficacy and tolerance of topical ciprofloxacin (0.3%) versus topical gentamicin (0.3%) in the treatment of simple, non-cholesteatomaous chronic otitis media in the suppurative phase].

PubMed

Lorente, J; Sabater, F; Maristany, M; Jiménez, R; Menem, J; Viñas, J; Quesada, P; Traserra, J; Dicenta, M; Abelló, P

1995-01-01

A multicentre double-blind randomized study was carried out to compare topical ciprofloxacin and topical gentamicin in the treatment of simple non-cholesteatomatous purulent chronic otitis media. Three hundred and eight patients were included in the study, 159 treated with ciprofloxacin and 149 treated with gentamicin. The percentage of clinical success (elimination of otorrhoea) was 95% with ciprofloxacin and 94% with gentamicin (ns). Likewise, the percentage of bacteriological erradication was 96% with ciprofloxacin and 93% with gentamicin. Both drugs were well tolerated, without changes in the audiometric values. In these patients, topical ciprofloxacin shows the same efficacy as topical gentamicin without any potential ototoxic effect.

Efficacy and Safety of Bendamustine and Ibrutinib in Previously Untreated Patients With Chronic Lymphocytic Leukemia: Indirect Comparison.

PubMed

Andrasiak, Iga; Rybka, Justyna; Knopinska-Posluszny, Wanda; Wrobel, Tomasz

2017-05-01

Bendamustine and ibrutinib are commonly used in the treatment of patients suffering from chronic lymphocytic leukemia (CLL). In this study we compare efficacy and safety bendamustine versus ibrutinib therapy in previously untreated patients with CLL. Because there are no head-to-head comparisons between bendamustine and ibrutinib, we performed indirect comparison using Bucher method. A systematic literature review was performed and 2 studies published before June 2016 were taken into analysis. Treatment with ibrutinib significantly improves PFS determined by investigator (HR of 0.3; P = .01) and OS (HR of 0.21; P < .001. Our study indicates that ibrutinib therapy improves PFS, OS and is superior in terms of safety comparing with bendamustine therapy in CLL patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Efficacy and safety of a hexanic extract of Serenoa repens (Permixon® ) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): Systematic review and meta-analysis of randomized controlled trials and observational studies.

PubMed

Vela-Navarrete, Remigio; Alcaraz, Antonio; Rodríguez-Antolín, Alfredo; Miñana López, Bernardino; Fernández-Gómez, Jesús M; Angulo, Javier C; Castro Díaz, David; Romero-Otero, Javier; Brenes, Francisco J; Carballido, Joaquín; Molero García, José M; Fernández-Pro Ledesma, Antonio; Cózar Olmos, José Manuel; Manasanch Dalmau, José; Subirana Cachinero, Isaac; Herdman, Michael; Ficarra, Vincenzo

2018-04-25

To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon), at a dose of 320 mg daily, as monotherapy for the treatment of LUTS/BPH. Systematic review and meta-analysis of randomized and observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge [ISI], Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data was collected on IPSS score, peak urinary flow (Qmax), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADR). Data obtained from randomized controlled trials (RCT) and observational studies (OS) were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies which included patients on longer-term treatment (≥one year). Data from 27 studies (15 RCTs and 12 OS) were included for meta-analysis (total N=5,800). Compared with placebo, the HESr was associated with 0.64 (95% CI -0.98 to -0.31) fewer voids per night (p=0.0001) and an additional mean increase in Qmax of 2.75 mL/s (95% CI 0.57 to 4.93; p=0.01). When compared with alpha-blockers, the HESr showed similar improvements on IPSS (WMD 0.57; 95%CI, -0.27 to 1.42; p=0.18) and a comparable increase in Qmax to tamsulosin (WMD -0.02; 95%CI, -0.71 to 0.66; p=0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5ARIs. Analysis of all available published data for the HESr showed a mean improvement in IPSS score from baseline of -5.73 points (95% CI -6.91 to -4.54; p<0.0001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on PSA. Prostate volume decreased slightly. Similar efficacy results were observed in patients treated for ≥1 year (n=447). The HESr had a favourable safety profile, with gastrointestinal disorders being the most frequent ADR (mean incidence of 3.8%). The present meta-analysis, which includes all available RCTs and OS, shows that the HESr (Permixon) reduced nocturia and improved Qmax compared with placebo and had a similar efficacy to tamsulosin and short-term 5-ARI in relieving LUTS. HESr (Permixon) appears to be an efficacious and well-tolerated therapeutic option for the long-term medical treatment of LUTS/BPH. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Development and study of self-efficacy scale in medication adherence among Iranian patients with hypertension

PubMed Central

Najimi, Arash; Mostafavi, Firoozeh; Sharifirad, Gholamreza; Golshiri, Parastoo

2017-01-01

BACKGROUND: This study was aimed at developing and studying the scale of self-efficacy in adherence to treatment in Iranian patients with hypertension. METHODS: A mix-method study was conducted on the two stages: in the first phase, a qualitative study was done using content analysis through deep and semi-structured interviews. After data analysis, the draft of tool was prepared. Items in the draft were selected based on the extracted concepts. In the second phase, validity and reliability of the instrument were implemented using a quantitative study. The prepared instrument in the first phase was studied among 612 participants. To test the construct validity and internal consistency, exploratory factor analysis and Cronbach's alpha were used, respectively. To study the validity of the final scale, the average score of self-efficacy in patients with controlled hypertension were compared with patients with uncontrolled hypertension. RESULTS: In overall, 16 patients were interviewed. Twenty-six items were developed to assess different concepts of self-efficacy. Concept-related items were extracted from interviews to study the face validity of the tool from patient's point of view. Four items were deleted because scored 0.79 in content validity. The mean of questionnaire content validity was 0.85. Items were collected in two factors with an eigenvalue >1. Four items were deleted with load factor <0.4. Reliability was 0.84 for the entire instrument. CONCLUSION: Self-efficacy scale in patients with hypertension is a valid and reliable instrument that can effectively evaluate the self-efficacy in medication adherence in the management of hypertension. PMID:29114551

Duration of efficacy increases with the repetition of botulinum toxin A injections in primary palmar hyperhidrosis: a study of 28 patients.

PubMed

Lecouflet, Marie; Leux, Christophe; Fenot, Marion; Célerier, Philippe; Maillard, Hervé

2014-06-01

Intradermal injections of botulinum toxin are effective but transitory in primary palmar hyperhidrosis. These injections are repeated when the symptoms recur. We do not know how the duration of efficacy changes when injections are repeated. In this retrospective study, we aimed to investigate the change in the duration of efficacy of botulinum toxin A (Dysport, Ipsen, Boulogne-Billancourt, France) with the repetition of injections in patients with primary palmar hyperhidrosis. From May 2001 to April 2012, 28 patients were treated with a dose of 250 U of botulinum toxin A per palm. We compared the duration of efficacy of the first and last toxin injections. The median duration of efficacy was 7 months for the first injection and 9.5 months for the last, the difference being statistically significant (P = .0002). Study limitations include a relatively small number of patients treated at a single center and evaluated retrospectively. To our knowledge, this study is the first to report a significant increase in the duration of efficacy of botulinum toxin A injections with the repetition of injections in patients with primary palmar hyperhidrosis. The reasons for this effect may be linked to the mechanism of action of botulinum toxin, and may improve our understanding of its pharmacologic effects. Copyright © 2014 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

[Lithium and anticonvulsants in bipolar depression].

PubMed

Samalin, L; Nourry, A; Llorca, P-M

2011-12-01

For decades, lithium and anticonvulsants have been widely used in the treatment of bipolar disorder. Their efficacy in the treatment of mania is recognized. These drugs have been initially evaluated in old and methodologically heterogeneous studies. Their efficacy in bipolar depression has not always been confirmed in more recent and methodologically more reliable studies. Thus, lithium's efficacy as monotherapy was challenged by the study of Young (2008) that showed a lack of efficacy compared with placebo in the treatment of bipolar depression. In two recent meta-analyses, valproate has shown a modest efficacy in the treatment of bipolar depression. As for lithium, valproate appeared to have a larger antimanic effect for acute phase and prophylaxis of bipolar disorder. In contrast, lamotrigine is more effective on the depressive pole of bipolar disorder with better evidence for the prevention of depressive recurrences. The guidelines include these recent studies and recommend lamotrigine as a first-line treatment of bipolar depression and for maintenance treatment. Because of more discordant data concerning lithium and valproate, these two drugs are placed either as first or as second line treatment of bipolar depression. The different safety/efficacy ratios of mood stabilizers underlie the complementarity and the importance of combination between them, or with some second-generation antipsychotics, in the treatment of patients with bipolar disorder. Copyright © 2011 L’Encéphale. Published by Elsevier Masson SAS.. All rights reserved.

The Quik Fix study: a randomised controlled trial of brief interventions for young people with alcohol-related injuries and illnesses accessing emergency department and crisis support care.

PubMed

Hides, Leanne; Kavanagh, David J; Daglish, Mark; Cotton, Susan; Connor, Jason P; Barendregt, Jan J; Young, Ross McD; Sanders, Davina; White, Angela; Mergard, Lance

2014-08-08

Alcohol is a major preventable cause of injury, disability and death in young people. Large numbers of young people with alcohol-related injuries and medical conditions present to hospital emergency departments (EDs). Access to brief, efficacious, accessible and cost effective treatment is an international health priority within this age group. While there is growing evidence for the efficacy of brief motivational interviewing (MI) for reducing alcohol use in young people, there is significant scope to increase its impact, and determine if it is the most efficacious and cost effective type of brief intervention available. The efficacy of personality-targeted interventions (PIs) for alcohol misuse delivered individually to young people is yet to be determined or compared to MI, despite growing evidence for school-based PIs. This study protocol describes a randomized controlled trial comparing the efficacy and cost-effectiveness of telephone-delivered MI, PI and an Assessment Feedback/Information (AF/I) only control for reducing alcohol use and related harm in young people. Participants will be 390 young people aged 16 to 25 years presenting to a crisis support service or ED with alcohol-related injuries and illnesses (including severe alcohol intoxication). This single blinded superiority trial randomized young people to (i) 2 sessions of MI; (ii) 2 sessions of a new PI or (iii) a 1 session AF/I only control. Participants are reassessed at 1, 3, 6 and 12 months on the primary outcomes of alcohol use and related problems and secondary outcomes of mental health symptoms, functioning, severity of problematic alcohol use, alcohol injuries, alcohol-related knowledge, coping self-efficacy to resist using alcohol, and cost effectiveness. This study will identify the most efficacious and cost-effective telephone-delivered brief intervention for reducing alcohol misuse and related problems in young people presenting to crisis support services or EDs. We expect efficacy will be greatest for PI, followed by MI, and then AF/I at 1, 3, 6 and 12 months on the primary and secondary outcome variables. Telephone-delivered brief interventions could provide a youth-friendly, accessible, efficacious, cost-effective and easily disseminated treatment for addressing the significant public health issue of alcohol misuse and related harm in young people. This trial is registered with the Australian and New Zealand Clinical Trials Registry ACTRN12613000108718.

Associations between job burnout and self-efficacy: a meta-analysis.

PubMed

Shoji, Kotaro; Cieslak, Roman; Smoktunowicz, Ewelina; Rogala, Anna; Benight, Charles C; Luszczynska, Aleksandra

2016-07-01

This study aimed at systematically reviewing and meta-analyzing the strength of associations between self-efficacy and job burnout (the global index and its components). We investigated whether these associations would be moderated by: (a) the type of measurement of burnout and self-efficacy, (b) the type of occupation, (c) the number of years of work experience and age, and (d) culture. We systematically reviewed and analyzed 57 original studies (N = 22,773) conducted among teachers (k = 29), health-care providers (k = 17), and other professionals (k = 11). The average effect size estimate for the association between self-efficacy and burnout was of medium size (-.33). Regarding the three burnout components, the largest estimate of the average effect (-.49) was found for the lack of accomplishment. The estimates of the average effect were similar, regardless of the type of measures of burnout and self-efficacy measurement (general vs. context-specific). Significantly larger estimates of the average effects were found among teachers (compared to health-care providers), older workers, and those with longer work experience. Significant self-efficacy-burnout relationships were observed across countries, although the strength of associations varied across burnout components, participants' profession, and their age.

Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

PubMed

Johns, Claire; Seav, Susan M; Dominick, Sally A; Gorman, Jessica R; Li, Hongying; Natarajan, Loki; Mao, Jun James; Irene Su, H

2016-04-01

Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.

Efficacy of acetylcholinesterase inhibitors versus nootropics in Alzheimer's disease: a retrospective, longitudinal study.

PubMed

Tsolaki, M; Pantazi, T; Kazis, A

2001-01-01

The aim of this study was to investigate the efficacy of nootropics (piracetam, aniracetam, nimodopine and dihydroergicristine) versus acetylcholinesterase inhibitors (AChE-Is) (tacrine and donepezil) in the treatment of Alzheimer's disease. This is a retrospective study of 510 patients with Alzheimer's disease. To determine clinical efficacy of treatment, we used the mean change over time in scores for the following tests: the Mini-Mental State Examination (MMSE); the Cambridge Cognitive Examination for the Elderly; and the Functional Rating Scale for Symptoms of Dementia. In all patients and in patients with severe Alzheimer's disease (baseline MMSE < 11), no significant differences were seen in the neuropsychological test scores between the two treatment groups. In patients with moderate dementia (baseline MMSE between 11 and 20), however, there was a significantly greater deterioration, as shown on the CAMCOG scale, after 12 months' treatment for patients receiving AChE-Is compared with those receiving nootropics (-4.38 for AChE-Is group versus 1.48 for nootropics group). For patients with mild dementia (baseline MMSE score between 21 and 26), there was a significantly greater deterioration on the MMSE scale for each time-point in the nootropics group compared with the AChE-Is group. In conclusion, we did not find any strong evidence that a difference in efficacy exists between AChE-Is and nootropics in the treatment of Alzheimer's disease.

A Systematic Review and Meta-Analysis of Efficacy, Cost-Effectiveness, and Safety of Selected Complementary and Alternative Medicine for Neck and Low-Back Pain

PubMed Central

Furlan, Andrea D.; Yazdi, Fatemeh; Tsertsvadze, Alexander; Gross, Anita; Van Tulder, Maurits; Santaguida, Lina; Gagnier, Joel; Ammendolia, Carlo; Dryden, Trish; Doucette, Steve; Skidmore, Becky; Daniel, Raymond; Ostermann, Thomas; Tsouros, Sophia

2012-01-01

Background. Back pain is a common problem and a major cause of disability and health care utilization. Purpose. To evaluate the efficacy, harms, and costs of the most common CAM treatments (acupuncture, massage, spinal manipulation, and mobilization) for neck/low-back pain. Data Sources. Records without language restriction from various databases up to February 2010. Data Extraction. The efficacy outcomes of interest were pain intensity and disability. Data Synthesis. Reports of 147 randomized trials and 5 nonrandomized studies were included. CAM treatments were more effective in reducing pain and disability compared to no treatment, physical therapy (exercise and/or electrotherapy) or usual care immediately or at short-term follow-up. Trials that applied sham-acupuncture tended towards statistically nonsignificant results. In several studies, acupuncture caused bleeding on the site of application, and manipulation and massage caused pain episodes of mild and transient nature. Conclusions. CAM treatments were significantly more efficacious than no treatment, placebo, physical therapy, or usual care in reducing pain immediately or at short-term after treatment. CAM therapies did not significantly reduce disability compared to sham. None of the CAM treatments was shown systematically as superior to one another. More efforts are needed to improve the conduct and reporting of studies of CAM treatments. PMID:22203884

Clinical efficacy of a novel topical formulation for vitiligo: compared evaluation of different treatment modalities in 149 patients.

PubMed

Buggiani, Gionata; Tsampau, Dionigi; Hercogovà, Jana; Rossi, Riccardo; Brazzini, Benedetta; Lotti, Torello

2012-01-01

Current vitiligo treatments are not always satisfactory for both patients and dermatologists. Recently, combination therapies have been introduced in order to obtain better results and reduce risks in the management of the disease. Novel efficacious products are needed to improve the therapeutic possibilities of dermatologists in the respect of safety for the patients. The objective of the present study was to evaluate the effects of a novel topical in a gel formulation containing phenylalanine, cucumis melo extract, and acetyl cysteine in vitiligo. The present study used an open observational study to evaluate the efficacy and safety of the investigated product, given alone or in combination with 311-nm narrow band microphototherapy. Results were compared with those obtained treating a matched patient population with microphototherapy alone and with clobetasol propionate 0.05% ointment alone. One hundred forty-nine patients suffering from symmetrical vitiligo affecting less than 10% of the skin surface were evaluated. Patients affected by acral vitiligo only were excluded from the analysis. Treatment duration was scheduled for 12 weeks. Excellent repigmentation (>75%) was achieved by 38-73% of patients, depending on the treatment regimen. Mild to moderate side effects were observed only in patients treated with clobetasol 0.05% ointment. The tested gel formulation showed a good efficacy in improving vitiligo repigmentation. No side effects were observed. © 2012 Wiley Periodicals, Inc.

Meta-analysis: comparative efficacy of different proton-pump inhibitors in triple therapy for Helicobacter pylori eradication.

PubMed

Vergara, M; Vallve, M; Gisbert, J P; Calvet, X

2003-09-15

It is not known whether certain proton-pump inhibitors are more efficacious than others when used in triple therapy for Helicobacter pylori eradication. To compare the efficacy of different proton-pump inhibitors in triple therapy by performing a meta-analysis. A MEDLINE search was performed. Abstracts of the European Helicobacter pylori Study Group and the American Gastroenterological Association congresses from 1996 to 2002 were also examined. Randomized studies with at least two branches of triple therapy that differed only in terms of type of proton-pump inhibitor were included in a meta-analysis using Review Manager 4.1. Fourteen studies were included. Intention-to-treat cure rates were similar for omeprazole and lansoprazole: 74.7% vs. 76%, odds ratio (OR) 0.91 [95% confidence interval (CI) 0.69-1.21] in a total of 1085 patients; for omeprazole and rabeprazole: 77.9% vs. 81.2%, OR 0.81 (95% CI 0.58-1.15) in a total of 825 patients; for omeprazole and esomeprazole: 87.7% vs. 89%, OR 0.89 (95% CI 0.58-1.35) in 833 patients; and for lansoprazole and rabeprazole: 81% vs. 85.7%, OR 0.77 (95% CI 0.48-1.22) in 550 patients. The efficacy of various proton-pump inhibitors seems to be similar when used for H. pylori eradication in standard triple therapy.

HIV prevention trial design in an era of effective pre-exposure prophylaxis.

PubMed

Cutrell, Amy; Donnell, Deborah; Dunn, David T; Glidden, David V; Grobler, Anneke; Hanscom, Brett; Stancil, Britt S; Meyer, R Daniel; Wang, Ronnie; Cuffe, Robert L

2017-01-01

Pre-exposure prophylaxis (PrEP) has demonstrated remarkable effectiveness protecting at-risk individuals from HIV-1 infection. Despite this record of effectiveness, concerns persist about the diminished protective effect observed in women compared with men and the influence of adherence and risk behaviors on effectiveness in targeted subpopulations. Furthermore, the high prophylactic efficacy of the first PrEP agent, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), presents challenges for demonstrating the efficacy of new candidates. Trials of new agents would typically require use of non-inferiority (NI) designs in which acceptable efficacy for an experimental agent is determined using pre-defined margins based on the efficacy of the proven active comparator (i.e. TDF/FTC) in placebo-controlled trials. Setting NI margins is a critical step in designing registrational studies. Under- or over-estimation of the margin can call into question the utility of the study in the registration package. The dependence on previous placebo-controlled trials introduces the same issues as external/historical controls. These issues will need to be addressed using trial design features such as re-estimated NI margins, enrichment strategies, run-in periods, crossover between study arms, and adaptive re-estimation of sample sizes. These measures and other innovations can help to ensure that new PrEP agents are made available to the public using stringent standards of evidence.

Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study

PubMed Central

Park, Won; Yoo, Dae Hyun; Miranda, Pedro; Brzosko, Marek; Wiland, Piotr; Gutierrez-Ureña, Sergio; Mikazane, Helena; Lee, Yeon-Ah; Smiyan, Svitlana; Lim, Mie-Jin; Kadinov, Vladimir; Abud-Mendoza, Carlos; Kim, HoUng; Lee, Sang Joon; Bae, YunJu; Kim, SuYeon; Braun, Jürgen

2017-01-01

Objectives To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS). Methods This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered intravenously every 8 weeks from week 62 to week 102. Efficacy end points included the proportion of patients achieving Assessment of SpondyloArthritis international Society (ASAS)20. Antidrug antibodies (ADAs) were measured using an electrochemiluminescent method. Data were analysed for patients treated with CT-P13 in the main PLANETAS study and the extension (maintenance group) and those who were switched to CT-P13 during the extension study (switch group). Results Overall, 174 (82.9%) of 210 patients who completed the first 54 weeks of PLANETAS and agreed to participate in the extension were enrolled. Among these, 88 were maintained on CT-P13 and 86 were switched to CT-P13 from RP. In these maintenance and switch groups, respectively, ASAS20 response rates at week 102 were 80.7% and 76.9%. ASAS40 and ASAS partial remission were also similar between groups. ADA positivity rates were comparable (week 102: 23.3% vs 27.4%). Adverse events led to treatment discontinuation during the extension study in 3 (3.3%) and 4 (4.8%) patients, respectively. Conclusions This is the first study to show that switching from RP to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS. In the maintenance group, CT-P13 was effective and well tolerated over 2 years of treatment. Trial registration number NCT01571206; Results. PMID:27117698

Therapy of the burnout syndrome.

PubMed

Korczak, Dieter; Wastian, Monika; Schneider, Michael

2012-01-01

The prevalence, diagnostics and therapy of the burnout syndrome are increasingly discussed in the public. The unclear definition and diagnostics of the burnout syndrome are scientifically criticized. There are several therapies with unclear evidence for the treatment of burnout in existence. The health technology assessment (HTA) report deals with the question of usage and efficacy of different burnout therapies. For the years 2006 to 2011, a systematic literature research was done in 31 electronic databases (e.g. EMBASE, MEDLINE, PsycINFO). Important inclusion criteria are burnout, therapeutic intervention and treatment outcome. 17 studies meet the inclusion criteria and are regarded for the HTA report. The studies are very heterogeneous (sample size, type of intervention, measuring method, level of evidence). Due to their study design (e.g. four reviews, eight randomized controlled trials) the studies have a comparable high evidence: three times 1A, five times 1B, one time 2A, two times 2B and six times 4. 13 of the 17 studies are dealing with the efficacy of psychotherapy and psychosocial interventions for the reduction of burnout (partly in combination with other techniques). Cognitive behaviour therapy leads to the improvement of emotional exhaustion in the majority of the studies. The evidence is inconsistent for the efficacy of stress management and music therapy. Two studies regarding the efficacy of Qigong therapy do not deliver a distinct result. One study proves the efficacy of roots of Rhodiola rosea (evidence level 1B). Physical therapy is only in one study separately examined and does not show a better result than standard therapy. Despite the number of studies with high evidence the results for the efficacy of burnout therapies are preliminary and do have only limited reach. The authors of the studies complain about the low number of skilled studies for the therapy of burnout. Furthermore, they point to the insufficient evaluation of the therapy studies and the need for further research. Some authors report the effects of considerable natural recovering. Numerous limitations affect the quality of the results. Intervention contents and duration, study design and study size are very diverse and do not permit direct comparison. Most of the samples are small by size with low statistical power, long-term follow-ups are missing. Comorbidities and parallel utilized therapies are insufficient documented or controlled. Most of the studies use the Maslach Burnout Inventory (MBI) as diagnostic or outcome-tool, but with different cut-off-points. It should be noticed that the validity of the MBI as diagnostic tool is not proved. Ethical, juridical and social determining factors are not covered or discussed in the studies. The efficacy of therapies for the treatment of the burnout syndrome is insufficient investigated. Only for cognitive behavioural therapy (CBT) exists an adequate number of studies which prove its efficacy. Big long-term experimental studies are missing which compare the efficacy of the single therapies and evaluate their evidence. The natural recovering without any therapy needs further research. Additionally, it has to be examined to what extent therapies and their possible effects are thwarted by the conditions of the working place and the working conditions.

Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.

PubMed

Feagan, Brian G; Macdonald, John K

2012-10-17

Oral 5-aminosalicylic acid (5-ASA) preparations were intended to avoid the adverse effects of sulfasalazine (SASP) while maintaining its therapeutic benefits. Previously, it was found that 5-ASA drugs in doses of at least 2 g/day, were more effective than placebo but no more effective than SASP for inducing remission in ulcerative colitis. This updated review includes more recent studies and evaluates the efficacy and safety of 5-ASA preparations used for the treatment of mild to moderately active ulcerative colitis. The primary objectives were to assess the efficacy, dose-responsiveness and safety of oral 5-ASA compared to placebo, SASP, or 5-ASA comparators for induction of remission in active ulcerative colitis. A secondary objective of this systematic review was to compare the efficacy and safety of once daily dosing of oral 5-ASA with conventional (two or three times daily) dosing regimens. A computer-assisted literature search for relevant studies (inception to January 20, 2012) was performed using MEDLINE, EMBASE and the Cochrane Library. Review articles and conference proceedings were also searched to identify additional studies. Studies were accepted for analysis if they were randomized controlled clinical trials of parallel design, with a minimum treatment duration of four weeks. Studies of oral 5-ASA therapy for treatment of patients with active ulcerative colitis compared with placebo, SASP or other formulations of 5-ASA were considered for inclusion. Studies that compared once daily 5-ASA treatment with conventional dosing of 5-ASA (two or three times daily) and 5-ASA dose ranging studies were also considered for inclusion. The outcomes of interest were the failure to induce global/clinical remission, global/clinical improvement, endoscopic remission, endoscopic improvement, adherence, adverse events, withdrawals due to adverse events, and withdrawals or exclusions after entry. Trials were separated into five comparison groups: 5-ASA versus placebo, 5-ASA versus sulfasalazine, once daily dosing versus conventional dosing, 5-ASA versus comparator 5-ASA, and 5-ASA dose-ranging. Placebo-controlled trials were subgrouped by dosage. SASP-controlled trials were subgrouped by 5-ASA/SASP mass ratios. Once daily versus conventional dosing studies were subgrouped by formulation. 5-ASA-controlled trials were subgrouped by common 5-ASA comparators (e.g. Asacol, Claversal, Salofalk and Pentasa). Dose-ranging studies were subgrouped by 5-ASA formulation. We calculated the relative risk (RR) and 95% confidence intervals (95% CI) for each outcome. Data were analyzed on an intention to treat basis. Forty-eight studies (7776 patients) were included. The majority of included studies were rated as low risk of bias. 5-ASA was significantly superior to placebo with regard to all measured outcome variables. Seventy-two per cent of 5-ASA patients failed to enter clinical remission compared to 85% of placebo patients (RR 0.86, 95% CI 0.81 to 0.91). A dose-response trend for 5-ASA was also observed. No statistically significant differences in efficacy were found between 5-ASA and SASP. Fifty-four per cent of 5-ASA patients failed to enter remission compared to 58% of SASP patients (RR 0.90, 95% CI 0.77 to 1.04). No statistically significant differences in efficacy or adherence were found between once daily and conventionally dosed 5-ASA. Forty-two per cent of once daily patients failed to enter clinical remission compared to 44% of conventionally dosed patients (RR 0.95, 95% CI 0.82 to 1.10). Eight per cent of patients dosed once daily failed to adhere to their medication regimen compared to 6% of conventionally dosed patients (RR 1.36, 95% CI 0.64 to 2.86). There does not appear to be any difference in efficacy among the various 5-ASA formulations. Forty-eight per cent of patients in the 5-ASA group failed to enter remission compared to 50% of patients in the 5-ASA comparator group (RR 0.94, 95% CI 0.86 to 1.03). A pooled analysis of the ASCEND (I, II and III, n = 1459 patients) studies found no statistically significant difference in clinical improvement between Asacol 4.8 g/day and 2.4 g/day used for the treatment of moderately active ulcerative colitis. Thirty-seven per cent of patients in the 4.8 g/day group failed to improve clinically compared to 41% of patients in the 2.4 g/day group (RR 0.89; 95% CI 0.78 to 1.01). Subgroup analysis indicated that patients with moderate disease may benefit from the higher dose of 4.8 g/day. One study compared (n = 123 patients) Pentasa 4 g/day to 2.25 g/day in patients with moderate disease. Twenty-five per cent of patients in the 4 g/day group failed to improve clinically compared to 57% of patients in the 2.25 g/day group (RR 0.44; 95% CI 0.27 to 0.71). A pooled analysis of two studies comparing MMX mesalamine 4.8 g/day to 2.4 g/day found no statistically significant difference in efficacy (RR 1.03, 95% CI 0.82 to 1.29). 5-ASA was generally safe and common adverse events included flatulence, abdominal pain, nausea, diarrhea, headache and worsening ulcerative colitis. There were no statistically significant differences in the incidence of adverse events between 5-ASA and placebo, once daily and conventionally dosed 5-ASA, 5-ASA and comparator 5-ASA formulation and 5-ASA dose ranging (high dose versus low dose) studies. SASP was not as well tolerated as 5-ASA. Twenty-nine percent of SASP patients experienced an adverse event compared to 15% of 5-ASA patients (RR 0.48, 95% CI 0.37 to 0.63). 5-ASA was superior to placebo and no more effective than SASP. Considering their relative costs, a clinical advantage to using oral 5-ASA in place of SASP appears unlikely. 5-ASA dosed once daily appears to be as efficacious and safe as conventionally dosed 5-ASA. Adherence does not appear to be enhanced by once daily dosing in the clinical trial setting. It is unknown if once daily dosing of 5-ASA improves adherence in a community-based setting. There do not appear to be any differences in efficacy or safety among the various 5-ASA formulations. A daily dosage of 2.4 g appears to be a safe and effective induction therapy for patients with mild to moderately active ulcerative colitis. Patients with moderate disease may benefit from an initial dose of 4.8 g/day.