The mediational role of panic self-efficacy in cognitive behavioral therapy for panic disorder: a systematic review and meta-analysis.

PubMed

Fentz, Hanne N; Arendt, Mikkel; O'Toole, Mia S; Hoffart, Asle; Hougaard, Esben

2014-09-01

Cognitive models of panic disorder (PD) with or without agoraphobia have stressed the role of catastrophic beliefs of bodily symptoms as a central mediating variable of the efficacy of cognitive behavioral therapy (CBT). Perceived ability to cope with or control panic attacks, panic self-efficacy, has also been proposed to play a key role in therapeutic change; however, this cognitive factor has received much less attention in research. The aim of the present review is to evaluate panic self-efficacy as a mediator of therapeutic outcome in CBT for PD using descriptive and meta-analytic procedures. We performed systematic literature searches, and included and evaluated 33 studies according to four criteria for establishing mediation. Twenty-eight studies, including nine randomized waitlist-controlled studies, showed strong support for CBT improving panic self-efficacy (criterion 1); ten showed an association between change in panic self-efficacy and change in outcome during therapy (criterion 2); three tested, and one established formal statistical mediation of panic self-efficacy (criterion 3); while four tested and three found change in panic self-efficacy occurring before the reduction of panic severity (criterion 4). Although none of the studies fulfilled all of the four criteria, results provide some support for panic self-efficacy as a mediator of outcome in CBT for PD, generally on par with catastrophic beliefs in the reviewed studies. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Axillary hyperhidrosis--efficacy and tolerability of an aluminium chloride antiperspirant. Prospective evaluation on 20 patients with idiopathic axillary hyperhidrosis].

PubMed

Streker, M; Reuther, T; Verst, S; Kerscher, M

2010-02-01

The purpose of this study was to evaluate the efficacy and tolerability of aluminium chloride gel for treatment of axillary hyperhidrosis. A total of 20 patients aged 22-38 (mean age: 26.9+/-4.3) with idiopathic axillary hyperhidrosis were included and treated with an antiperspirant (Sweat-off, Sweat-off GmbH, Hügelsheim). Study duration was 42 days. Treatment efficacy was evaluated clinically, as well as by starch-iodine test, gravimetric analysis and evaluation of the skin surface pH. After treatment there was a significant clinical improvement accompanied by significant qualitative and quantitative reduction of sweat as well as a significant reduction of skin surface pH. Except for slight skin irritation in 6 patients, there were no other side effects. Patient satisfaction improved markedly during the study. Treatment of axillary hyperhidrosis with aluminium chloride is an effective, safe and inexpensive treatment modality.

Nutraceuticals: do they represent a new era in the management of osteoarthritis? - a narrative review from the lessons taken with five products.

PubMed

Henrotin, Y; Lambert, C; Couchourel, D; Ripoll, C; Chiotelli, E

2011-01-01

The aim of this first global systematic review on selected nutraceuticals was to synthesize and evaluate scientific relevant data available in the literature. Evidences that can support health, physiological or functional benefit on osteoarthritis (OA) were gathered and the level of evidence relative to each of these ingredients was highlighted. Relevant scientific data (positive or not) regarding OA were searched for five groups of compounds (avocado/soybean unsaponifiables (ASU), n-3 polyunsaturated fatty acids, collagen hydrosylates (CHs), vitamin D, polyphenols) within preclinical (in vitro and in vivo), epidemiological, and clinical studies. The following criteria were evaluated to assess the methodology quality of each study: (1) study question; (2) study population; (3) primary endpoint; (4) study design (randomization, control, blinding, duration of follow up); (5) data analysis and interpretation. A scientific consensus was determined for all studied nutraceuticals to evaluate their efficacy in OA. The studied compounds demonstrated different potencies in preclinical studies. Most of them have demonstrated anti-catabolic and anti-inflammatory effects by various inhibitory activities on different mediators. Vitamin D showed a pro-catabolic effect in vitro and the polyphenol, Genistein, had only anti-inflammatory potency. The evaluation of the clinical data showed that ASU was the only one of the studied ingredients to present a good evidence of efficacy, but the efficient formulation was considered as a drug in some countries. Pycnogenol showed moderate evidence of efficacy, and vitamin D and collagen hydrolysate demonstrated a suggestive evidence of efficacy, whereas curcumin, epigallocatechin-3-gallate (EGCG) and resveratrol had only preclinical evidence of efficacy due to the lack of clinical data. The literature gathered for n-3 PUFA, nobiletin and genistein was insufficient to conclude for their efficacy in OA. Additional data are needed for most of the studied nutraceuticals. Studies of good quality are needed to draw solid conclusions regarding their efficacy but nutraceuticals could represent good alternates for OA management. Their use should be driven by any recommendations. Copyright © 2010 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Reinforcement magnitude: an evaluation of preference and reinforcer efficacy.

PubMed

Trosclair-Lasserre, Nicole M; Lerman, Dorothea C; Call, Nathan A; Addison, Laura R; Kodak, Tiffany

2008-01-01

Consideration of reinforcer magnitude may be important for maximizing the efficacy of treatment for problem behavior. Nonetheless, relatively little is known about children's preferences for different magnitudes of social reinforcement or the extent to which preference is related to differences in reinforcer efficacy. The purpose of the current study was to evaluate the relations among reinforcer magnitude, preference, and efficacy by drawing on the procedures and results of basic experimentation in this area. Three children who engaged in problem behavior that was maintained by social positive reinforcement (attention, access to tangible items) participated. Results indicated that preference for different magnitudes of social reinforcement may predict reinforcer efficacy and that magnitude effects may be mediated by the schedule requirement.

Association of depression and pain interference with disease-management self-efficacy in community-dwelling individuals with spinal cord injury.

PubMed

Pang, Marco Y C; Eng, Janice J; Lin, Kwan-Hwa; Tang, Pei-Fang; Hung, Chihya; Wang, Yen-Ho

2009-11-01

To determine factors influencing disease-management self-efficacy in individuals with spinal cord injury. A cross-sectional study. Forty-nine community-dwelling individuals with chronic spinal cord injury (mean age 44 years) participated in the study. Each subject was evaluated for disease-management self-efficacy (Self-efficacy for Managing Chronic Disease), depression (10-item Center for Epidemiologic Studies Depression Scale), pain interference (Pain Interference Scale), and availability of support (Interpersonal Support Evaluation List short form). Multiple regression analysis was performed to determine the relative contributions of these factors to disease-management self-efficacy. The mean disease-management self-efficacy score was 6.5 out of 10 (standard deviation 1.6). Bivariate correlation analysis showed that higher self-efficacy was significantly correlated with longer time since injury (r = 0.367, p = 0.010), better social support (r = 0.434, p = 0.002), lower pain interference (r = -0.589, p <0.001), and less severe depressive symptoms (r=-0.463, p=0.001). In multiple regression analysis, only lower pain interference and less severe depressive symptoms were significantly associated with higher disease-management self-efficacy (F 4,44=10.249, R2=0.482, p<0.001). Disease-management self-efficacy is suboptimal in many community-living people with spinal cord injury. This research suggests that rehabilitation of patients with spinal cord injury should include self-efficacy-enhancing strategies. Alleviation of depressive symptoms and pain self-management may be important for improving disease-management self-efficacy in this population, but this requires further study.

Development of Condom-Use Self-Efficacy over 36 Months among Early Adolescents: A Mediation Analysis

ERIC Educational Resources Information Center

Chen, Xinguang; Dinaj-Koci, Veronica; Brathwaite, Nanika; Cottrell, Lesley; Deveaux, Lynette; Gomez, Perry; Harris, Carole; Li, Xiaoming; Lunn, Sonja; Marshall, Sharon; Stanton, Bonita

2012-01-01

This research evaluates condom-use self-efficacy and its increase throughout adolescence. Documentation of the development of condom-use self-efficacy would be important for prevention efforts given the influence of self-efficacy on actual condom usage. This study assesses a hypothesized mediation mechanism of the development of self-efficacy…

Mind over Matter: Contributing Factors to Self-Efficacy in Montessori Teachers

ERIC Educational Resources Information Center

Bhatia, Punum

2012-01-01

Interpreting Albert Bandura's term "self-efficacy" as the individual's belief in his own abilities to succeed in spite of the given circumstances, this study seeks to identify the influences which lead to self-efficacy in Montessori teachers. In order to evaluate perceptions of self-efficacy, 35 pre-service teachers in the…

A Psychometric Evaluation of the Self-Presentational Efficacy Scale

ERIC Educational Resources Information Center

Lamarche, Larkin; Gammage, Kimberley L.; Sullivan, Philip J.; Gabriel, David A.

2013-01-01

This study examined the psychometric properties of the Self-Presentational Efficacy Scale (SPES) developed by Gammage, Hall, and Martin Ginis (2004). University students (196 men and 269 women) completed the SPES and measures of social physique anxiety, fear of negative evaluation, and physical activity. Participants also completed the SPES a…

Evaluation of the Positive Prevention HIV/STD Curriculum

ERIC Educational Resources Information Center

LaChausse, Robert G.

2006-01-01

This study evaluated the effectiveness of Positive Prevention, a theory-based, HIV/STD prevention education curriculum for high school youth. Three hundred fifty-three students participated in a longitudinal experimental design to determine the impact of the curriculum on HIV/AIDS knowledge, self-efficacy to abstain from sex, self-efficacy of…

Evaluation of Efficacy of Preventive Measures under Hypokinesia.

ERIC Educational Resources Information Center

Zorbas, Yan G.; Matveyev, Ivan O.

1987-01-01

The study evaluated the efficacy of physical exercise alone and in combination with other preventive measures with 24 adult male subjects kept under a bed rest regime. It was concluded that physical exercise was the most reliable measure in counteracting neuromuscular system disorders under diminished muscular activity conditions. (Author/DB)

An Evaluation of Videoconferencing as a Supportive Technology for Practicum Supervision

ERIC Educational Resources Information Center

Dymond, Stacy K.; Renzaglia, Adelle; Halle, James W.; Chadsey, Janis; Bentz, Johnell L.

2008-01-01

In this study, the authors determine the efficacy of videoconferencing to supervise pre-service special education teachers. Efficacy is determined by (a) assessing interobserver reliability between on-site and off-site observers and (b) evaluating the feasibility and practicality of the videoconferencing technology. Data are collected in two…

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 Central

Llorca, Pierre-Michel; Lançon, Christophe; Brignone, Mélanie; Painchault, Caroline; Rive, Benoit; Toumi, Mondher; François, Clément

2015-01-01

Objective 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. Methods 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. Results 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. Conclusions 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. PMID:27123184

The revised scale for caregiving self-efficacy: reliability and validity studies.

PubMed

Steffen, Ann M; McKibbin, Christine; Zeiss, Antonette M; Gallagher-Thompson, Dolores; Bandura, Albert

2002-01-01

Two samples of family caregivers (Study 1: N = 169; Study 2: N = 145) of cognitively impaired older adults were used to revise, extend, and evaluate a measure of perceived self-efficacy for caregiving tasks. The Revised Scale for Caregiving Self-Efficacy measures 3 domains of caregiving self-efficacy: Obtaining Respite, Responding to Disruptive Patient Behaviors, and Controlling Upsetting Thoughts. The 3 subscales show strong internal consistency and adequate test-retest reliability. Construct validity is supported by relationships between these 3 facets of perceived caregiving efficacy and depression, anxiety, anger, perceived social support, and criticism expressed in speech samples. The Revised Scale for Caregiving Self-Efficacy has potential uses for both research and clinical purposes.

Treatment Outcomes and Efficacy in the Schools.

ERIC Educational Resources Information Center

Logemann, Jeri A.

1998-01-01

Introduces six articles which address treatment outcomes and efficacy in audiology and speech-language pathology in the schools. Stresses the importance of practitioners participating in studies of treatment outcomes and efficacy to demonstrate that their evaluations and treatments make a significant difference to individuals served. (DB)

Implementation of Effective Intervention: An Empirical Study to Evaluate the Efficacy of Fountas & Pinnell's Leveled Literacy Intervention System (LLI). 2009-2010

ERIC Educational Resources Information Center

Ransford-Kaldon, Carolyn R.; Flynt, E. Sutton; Ross, Cristin L.; Franceschini, Louis; Zoblotsky, Todd; Huang, Ying; Gallagher, Brenda

2010-01-01

This report summarizes evaluation results for an efficacy study of the Leveled Literacy Intervention system (LLI) implemented in Tift County Schools (TCS) in Georgia and the Enlarged City School District of Middletown (ECSDM) in New York during the 2009-2010 school year. Developed by Fountas & Pinnell (2009) and published by Heinemann, LLI is…

Comparative efficacy and safety of two 0.025% tretinoin gels: results from a multicenter double-blind, parallel study.

PubMed

Lucky, A W; Cullen, S I; Jarratt, M T; Quigley, J W

1998-04-01

The addition of polyolprepolymer-2 in tretinoin formulations may reduce tretinoin-induced cutaneous irritation. This study compared the efficacy and safety of a new 0.025% tretinoin gel containing polyolprepolymer-2, its vehicle, and a commercially-available 0.025% tretinoin gel in patients with mild to moderate acne vulgaris. In this 12-week multicenter, double-blind, parallel group study, efficacy was evaluated by objective lesion counts and the investigators' global evaluations. Subjective assessment of cutaneous irritation by the investigators and patients evaluated safety. The efficacy of the two active treatments in this 215 patient study was comparable, and both treatments were statistically significantly more effective than vehicle. When compared with the commercially-available tretinoin gel, the formulation containing polyolprepolymer-2 demonstrated statistically significantly less peeling at days 28, 56, and 84, statistically significantly less dryness by day 84, and statistically significantly less itching at day 14. Irritation scores for the formulation containing polyolprepolymer-2 were numerically lower but not statistically different from those of the commercially-available gel for erythema and burning. The number of cutaneous and noncutaneous adverse events were similar for both active medications. The two 0.025% gels studied demonstrated comparable efficacy. However, the gel formulation containing polyolprepolymer-2 caused significantly less peeling and drying than the commercially-available formulation by day 84 of the study.

Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms.

PubMed

Albrecht, Helmut; Vernon, Margaret; Solomon, Gail

2012-12-27

Guaifenesin is a component of medicines used to improve symptoms associated with upper respiratory tract infections. Patient-reported outcome instruments are valuable for evaluating symptom improvements; however, a validated tool to assess efficacy of mucoactive drugs does not exist. We compared the efficacy of extended-release guaifenesin with placebo for treatment of symptoms of upper respiratory tract infection using subjective efficacy assessments in a pilot study and confirmed precision of assessments in a validation study. The pilot study was a randomized, double-blind study where patients were dosed with either 1200 mg extended-release guaifenesin (n = 188) or placebo (n = 190), every 12 hours for 7 days. Efficacy was assessed using subjective measures including the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and the Wisconsin Upper Respiratory Symptom Survey. End-of-study assessments were completed by patients and investigator. The validation study consisted of two phases. In Phase I, subjects completed interviews to gather evidence to support the content validity of the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and Patient's End-of-Treatment Assessment. Phase II examined the psychometric properties of assessments evaluated in Phase I of the validation study using data from the pilot study. Subjective measures of efficacy at Day 4 showed the most prominent difference between treatment groups, in favor of guaifenesin. The 8-symptom related questions (SUM8) in the Daily Cough and Phlegm Diary, analyzed as a composite score appeared to be the strongest candidate endpoint for further evaluation. Results from the interviews in Phase I supported the content of the assessments which were validated during Phase II. Treatments were well tolerated. Results from the clinical pilot and validation studies showed that the SUM8 diary scores were robust and reliable for use as efficacy endpoints in studies of mucoactive drugs. The study was registered with clinicaltrials.gov (NCT01046136).

Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms

PubMed Central

2012-01-01

Background Guaifenesin is a component of medicines used to improve symptoms associated with upper respiratory tract infections. Patient-reported outcome instruments are valuable for evaluating symptom improvements; however, a validated tool to assess efficacy of mucoactive drugs does not exist. We compared the efficacy of extended-release guaifenesin with placebo for treatment of symptoms of upper respiratory tract infection using subjective efficacy assessments in a pilot study and confirmed precision of assessments in a validation study. Methods The pilot study was a randomized, double-blind study where patients were dosed with either 1200 mg extended-release guaifenesin (n = 188) or placebo (n = 190), every 12 hours for 7 days. Efficacy was assessed using subjective measures including the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and the Wisconsin Upper Respiratory Symptom Survey. End-of-study assessments were completed by patients and investigator. The validation study consisted of two phases. In Phase I, subjects completed interviews to gather evidence to support the content validity of the Daily Cough and Phlegm Diary, the Spontaneous Symptom Severity Assessment and Patient’s End-of-Treatment Assessment. Phase II examined the psychometric properties of assessments evaluated in Phase I of the validation study using data from the pilot study. Results Subjective measures of efficacy at Day 4 showed the most prominent difference between treatment groups, in favor of guaifenesin. The 8-symptom related questions (SUM8) in the Daily Cough and Phlegm Diary, analyzed as a composite score appeared to be the strongest candidate endpoint for further evaluation. Results from the interviews in Phase I supported the content of the assessments which were validated during Phase II. Treatments were well tolerated. Conclusions Results from the clinical pilot and validation studies showed that the SUM8 diary scores were robust and reliable for use as efficacy endpoints in studies of mucoactive drugs. Trial registration The study was registered with clinicaltrials.gov (NCT01046136). PMID:23270519

The Relationship between Teachers' Computer Self-Efficacy and Technology Integration in a School District's Bring Your Own Technology Initiative

ERIC Educational Resources Information Center

Ellis, Ashley F.

2014-01-01

The purpose of this mixed methods program evaluation study was to investigate the ways in which one public school district and its teachers implemented a Bring Your Own Technology (BYOT) initiative. This study also measured teachers' computer self-efficacy, as measured by Cassidy and Eachus' (2002) Computer User Self-Efficacy Scale, and…

Efficacy of Atomoxetine in Children with Severe Autistic Disorders and Symptoms of ADHD: An Open-Label Study

ERIC Educational Resources Information Center

Charnsil, Chawanun

2011-01-01

Objective: This study aims to examine the efficacy of atomoxetine in treating symptoms of attention deficit hyperactivity disorder (ADHD) in children with severe autistic disorder. Method: Children with severe autistic disorder who had symptoms of ADHD were given atomoxetine for 10 weeks. The efficacy of atomoxetine was evaluated by using the…

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.

A self-efficacy questionnaire regarding leisure time physical activity: Psychometric properties among Iranian male adolescents.

PubMed

Abasi, Mohammad Hadi; Eslami, Ahmad Ali; Rakhshani, Fatemeh; Shiri, Mansoor

2016-01-01

Attention to different aspects of self-efficacy leads to actual evaluation of self-efficacy about physical activity. This study was carried out in order to design and determine psychometric characteristics of a questionnaire for evaluation of self-efficacy about leisure time physical activity (SELPA) among Iranian adolescent boys, with an emphasis on regulatory self-efficacy. This descriptive-analytic study was conducted in 734 male adolescents aged 15-19 years in Isfahan. After item generation and item selection based on review of literature and other questionnaires, content validity index (CVI) and content validity ratio (CVR) were determined and items were modified employing the opinions of expert panel (N = 10). Comprehensibility of the questionnaire was determined by members of target group (N = 35). Exploratory factors analysis (EFA) was operated on sample 1 (N 1 = 325) and confirmatory factors analysis (CFA) on sample 2 (N 2 = 347). Reliability of SELPA was estimated via internal consistency method. According to EFA, barrier self-efficacy and scheduling self-efficacy are the two main aspects of SELPA with the total variance of 65%. The suggested model was confirmed by CFA and all fitness indices of the corrected model were good. Cronbach's alpha was totally estimated as 0.89 and for barrier and scheduling self-efficacy, it was 0.86 and 0.81, respectively. The results provide some evidence for acceptable validity and reliability of SELPA in Iranian adolescent boys. However, further investigations, especially for evaluation of predictive power of the questionnaire, are necessary.

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.

The Effect of School Practices on Teacher Candidates' Sense of Efficacy Relating to Use of Drama in Education

ERIC Educational Resources Information Center

Tanriseven, Isil

2013-01-01

The aim of this study is to research the effect of school practices on teacher candidates' sense of efficacy relating to planning, implementing, evaluating drama activities, and the sense of general efficacy relating to use of drama in education. The study was conducted with 52 students attending the 2nd year of their course of study in Mersin…

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.

Reinforcement Magnitude: An Evaluation of Preference and Reinforcer Efficacy

PubMed Central

Trosclair-Lasserre, Nicole M; Lerman, Dorothea C; Call, Nathan A; Addison, Laura R; Kodak, Tiffany

2008-01-01

Consideration of reinforcer magnitude may be important for maximizing the efficacy of treatment for problem behavior. Nonetheless, relatively little is known about children's preferences for different magnitudes of social reinforcement or the extent to which preference is related to differences in reinforcer efficacy. The purpose of the current study was to evaluate the relations among reinforcer magnitude, preference, and efficacy by drawing on the procedures and results of basic experimentation in this area. Three children who engaged in problem behavior that was maintained by social positive reinforcement (attention, access to tangible items) participated. Results indicated that preference for different magnitudes of social reinforcement may predict reinforcer efficacy and that magnitude effects may be mediated by the schedule requirement. PMID:18595284

Efficacy of Web-Based Personalized Normative Feedback: A Two-Year Randomized Controlled Trial

ERIC Educational Resources Information Center

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

2010-01-01

Objective: Web-based brief alcohol interventions have the potential to reach a large number of individuals at low cost; however, few controlled evaluations have been conducted to date. The present study was designed to evaluate the efficacy of gender-specific versus gender-nonspecific personalized normative feedback (PNF) with single versus…

Promoting Social Skill Development in Children with Pervasive Developmental Disorders: A Feasibility and Efficacy Study

ERIC Educational Resources Information Center

Koenig, Kathleen; White, Susan Williams; Pachler, Maryellen; Lau, Monika; Lewis, Moira; Klin, Ami; Scahill, Lawrence

2010-01-01

A randomized controlled design was employed to evaluate a social skills intervention for children with pervasive developmental disorders. Aims included evaluating the acceptability of the program and gathering preliminary evidence on efficacy. Forty-four children, ages 8-11 years, were randomly assigned to treatment or wait list. Treatment…

Core Self-Evaluations, Career Decision Self-Efficacy, and Vocational Identity among Greek Adolescents

ERIC Educational Resources Information Center

Koumoundourou, Georgia A.; Kounenou, Kalliopi; Siavara, Eftyxia

2012-01-01

This study explored the mediating role of career decision self-efficacy between core self-evaluations (CSE), a newly established construct within the personality domain, and adolescents' vocational identity. Using a sample of 200 Greek high school students, it was found that for female adolescents CSE influenced vocational identity both directly…

Evaluating Ritual Efficacy: Evidence from the Supernatural

ERIC Educational Resources Information Center

Legare, Cristine H.; Souza, Andre L.

2012-01-01

Rituals pose a cognitive paradox: although widely used to treat problems, rituals are causally opaque (i.e., they lack a causal explanation for their effects). How is the efficacy of ritual action evaluated in the absence of causal information? To examine this question using ecologically valid content, three studies (N=162) were conducted in…

EVALUATION OF THE EFFICACY OF EXTRAPOLATION POPULATION MODELING TO PREDICT THE DYNAMICS OF AMERICAMYSIS BAHIA POPULATIONS IN THE LABORATORY

EPA Science Inventory

An age-classified projection matrix model has been developed to extrapolate the chronic (28-35d) demographic responses of Americamysis bahia (formerly Mysidopsis bahia) to population-level response. This study was conducted to evaluate the efficacy of this model for predicting t...

Persian version of the Moorong Self-Efficacy Scale: psychometric study among subjects with physical disability.

PubMed

Rajati, Fatemeh; Ghanbari, Masoud; Hasandokht, Tolou; Hosseini, Seyed Younes; Akbarzadeh, Rasool; Ashtarian, Hossein

2017-11-01

Self-efficacy plays a key role in varying areas of human conditions which can be measured by different scales. The present study was aimed to evaluate the psychometric properties of Moorong Self-Efficacy Scale (MSES) in Iranian Subjects with Physical Disability (SWPD). Data were collected by face-to-face interviews and self-report surveys from 214 subjects. The face and content validity, and reliability were evaluated. Discriminates were evaluated between the sub-groups of disability levels, physical activity, and health condition levels. The concurrent, convergent, divergent, and construct validity were assessed by short form health survey scale (SF-36), general self-efficacy scale (GSES), hospital anxiety and depression scale (HADS), respectively. Replaceable exploratory factor analysis was evaluated. SPSS software was used for statistical analysis. There were acceptable face and content validity, and reliability. Furthermore, significant correlation was found between PSES and SF-36 (p < 0.001). Self-efficacy was statistically different among the disability levels (p = 0.02), physical activity levels (p < 0.001), and health status (p = 0.001). The correlation of Persian Self-Efficacy Scale (PSES) scores with GSES (r = 0.61, p < 0.001), and HADS (R = -0.53, p < 0.001) was significant. This scale yielded a two-dimensional structure, with a good internal replicability. The external replicability was satisfactory when we compared factor loadings with the original study. The PSES is a valid, reliable and sensitive tool to measure the self-efficacy among SWPD for planning and managing of disability problems. Implications for rehabilitation Psychometric properties of the Persian version of self-Efficacy scale (PSES) appear to be similar to original, English version. The PSES has been shown to have validity and reliability in Persian physical disables and can be used for patients with more different types of physical disability than individuals suffering from only Spinal Cord Injury (SCI). The PSES can be used in clinical practice and research work to evaluate the patients' confidence in performing daily activities.

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.

Teacher' Interpersonal Self-Efficacy: Evaluation and Predictive Capacity of Teacher Burnout

ERIC Educational Resources Information Center

García-Ros, Rafael; Fuentes, María C.; Fernández, Basilio

2015-01-01

Introduction: This study analyzed the predictive capacity and incremental validity of teachers' interpersonal self-efficacy on their levels of burnout. First, it presents the validation process of a Spanish adaptation of the Teacher Interpersonal Self-Efficacy Scale--TISES--(Browers & Tomic, 1999, 2001). Second, the predictive capacity of…

A Phase III Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg Plus Acarbose 50 mg Tablets) Versus Acarbose Alone in Subjects With Type 2 Diabetes Mellitus

ClinicalTrials.gov

2010-11-19

The Objectives of the Study is to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg; Plus Acarbose 50 mg Tablets) Thrice Daily Versus Acarbose 50 mg Thrice Daily Over 16 Weeks in; Subjects With Type 2 Diabetes Mellitus.

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.

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

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.

Randomized double-blind placebo-controlled multicenter evaluation of efficacy and dose finding of midodrine hydrochloride in women with mild to moderate stress urinary incontinence: a phase II study.

PubMed

Weil, E H; Eerdmans, P H; Dijkman, G A; Tamussino, K; Feyereisl, J; Vierhout, M E; Schmidbauer, C; Egarter, C; Kölle, D; Plasman, J E; Heidler, H; Abbühl, B E; Wein, W

1998-01-01

Midodrine is a potent and selective alpha1-receptor agonist and its potential to increase urethral closure pressure could be useful in the treatment of female stress incontinence. The aim of this randomized double-blind placebo-controlled multicenter study was to evaluate the efficacy and safety of midodrine for the treatment of stress urinary incontinence. The primary criterion of efficacy was the maximum urethral closure pressure at rest. Voiding diaries, symptom and incontinence questionnaires and patient/investigator global assessment were also used to evaluate its efficacy. After 4 weeks of treatment no significant changes in MUCP were found. The global assessment by the patient and investigator did indicate that patients on active treatment had a more positive assessment than the placebo group. In conclusion, midodrine did not cause significant improvements in urodynamic parameters, but there were subjective improvements in some of the patients in the treated groups. Furthermore midodrine was well tolerated.

Evaluating ritual efficacy: evidence from the supernatural.

PubMed

Legare, Cristine H; Souza, André L

2012-07-01

Rituals pose a cognitive paradox: although widely used to treat problems, rituals are causally opaque (i.e., they lack a causal explanation for their effects). How is the efficacy of ritual action evaluated in the absence of causal information? To examine this question using ecologically valid content, three studies (N=162) were conducted in Brazil, a cultural context in which rituals called simpatias are used to treat a great variety of problems ranging from asthma to infidelity. Using content from existing simpatias, experimental simpatias were designed to manipulate the kinds of information that influences perceptions of efficacy. A fourth study (N=68) with identical stimuli was conducted with a US sample to assess the generalizability of the findings across two different cultural contexts. The results provide evidence that information reflecting intuitive causal principles (i.e., repetition of procedures, number of procedural steps) and transcendental influence (i.e., presence of religious icons) affects how people evaluate ritual efficacy. Copyright © 2012 Elsevier B.V. All rights reserved.

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.

Development and evaluation of a new occupational medicine teaching module to advance self-efficacy and knowledge among medical students.

PubMed

Braeckman, Lutgart; De Clercq, Bart; Janssens, Heidi; Gehanno, Jean-François; Bulat, Petar; Pauncu, Elena-Ana; Smits, Paul; van Dijk, Frank; Vanderlinde, Ruben; Valcke, Martin

2013-11-01

Self-efficacy is defined as a person's beliefs in his or her abilities to successfully complete a task, and has been shown to influence student motivation and academic achievement. The purpose of this study was to evaluate the impact of a new European teaching module in occupational medicine on undergraduate students' self-efficacy and knowledge in the subject matter. Pre-, in-between, and posttraining tests were used to assess self-efficacy and knowledge building of 261 third-year medical students on occupational health issues. Determinants of self-efficacy and knowledge were also identified. Repeated measurement data were analyzed with multilevel statistical procedures. The level of self-efficacy and knowledge in occupational medicine increased after the training. Students who frequently attended the lectures scored significantly higher than sporadic attendees. There was no relation between the level of self-efficacy and the final knowledge score. Teaching with the new occupational medicine module was effective. Lecture attendance is an important determinant of self-efficacy and performance. Self-efficacy was not associated with knowledge score. Encouraging classroom participation may enhance student achievement.

Improvement in Stress, General Self-Efficacy, and Health Related Quality of Life following Patient Education for Patients with Neuroendocrine Tumors: A Pilot Study.

PubMed

Haugland, Trude; Veenstra, Marijke; Vatn, Morten H; Wahl, Astrid K

2013-01-01

The purpose of the study was to evaluate changes in general self-efficacy, health related quality of life (HRQoL), and stress among patients with neuroendocrine tumors (NET) following a multidisciplinary educational intervention. Forty-one patients were enrolled in this exploratory pilot study. A total of 37 patients completed the full 26-week intervention based on the principles of self-efficacy. General self-efficacy was measured by the General Self-Efficacy Scale, HRQoL was measured with the SF-36, and stress was measured with the Impact of Event Scale. Mixed effect models were used to evaluate changes in general self-efficacy, mental and physical components of HRQoL, and stress adjusting for demographic and clinical variables. Results showed significant improvements in patients' general self-efficacy (β = 0.71; P < 0.05), physical component scores of HRQoL (β = 3.09; P < 0.01), and stress (β = -2.10, P = 0.008). Findings suggest that patients with NET have the capacity to improve their ability to cope with their disease, problem-solve, improve their physical status, and reduce their stress following an educational intervention based on the principles of self-efficacy. These preliminary data provide a basis for future randomized controlled trials to test interventions to improve HRQoL for patients with NET.

[A meta-analysis of the effects of a self-efficacy promoting program].

PubMed

Cha, Bo Kyoung; Chang, Hae Kyung; Sohn, Jung Nam

2004-10-01

This meta-analysis was conducted to evaluate the effects of a self-efficacy promoting program and analyze its components. The material used for this study were 18 self-efficacy promoting program studies carried out from Jan. 1980 to Oct. 2003. The studies were analyzed in different categories: 1) types of dependent variables 2) sample characteristics 3) types of experimental treatment conditions 4) types of self-efficacy source and 5) total amount of time 1) The weighted mean of a self-efficacy promoting program ranged from 1.383 to 0.015 2) for the experimental treatment condition, exercise had a much larger effect in increasing general self-efficacy and self-care than education 3) the studies using 3 sources had a much larger effect in increasing self-care than the studies using 4 sources 4) a time period longer than 900 minutes had a much larger effect in increasing specific self-efficacy, general self-efficacy and self-care than in a time period shorter than 900 minutes. 5) effect size of specific self-efficacy was significantly higher than general self-efficacy. These results can be used to guide the development of a self-efficacy promoting program for nursing practice.

An Interactive Web-Based Program for Stepfamilies: Development and Evaluation of Efficacy

ERIC Educational Resources Information Center

Gelatt, Vicky A.; Adler-Baeder, Francesca; Seeley, John R.

2010-01-01

This study evaluated the efficacy of a family life education program for stepfamilies that is self-administered, interactive, and web-based. The program uses behavior-modeling videos to demonstrate effective couple, parenting, and stepparenting practices. A diverse sample of 300 parents/stepparents of a child aged 11-15 years were randomized into…

Evaluating the Efficacy of Children Participating in Home Instruction for Parents of Preschool Youngsters and Head Start

ERIC Educational Resources Information Center

Brown, Amber L; Lee, Joohi

2017-01-01

The purpose of this study was to evaluate the efficacy of the Home Instruction for Parents of Preschool Youngsters program when implemented within Head Start programs by measuring children's language proficiency scores. Participants were kindergarteners concurrently enrolled in both a Head Start program and the Home Instruction for Parents of…

Evaluating the Efficacy of Mathematics, Science and Technology Teacher Preparation Academies in Texas

ERIC Educational Resources Information Center

Brown, Danielle Bairrington; Alford, Beverly L.; Rollins, Kayla Braziel; Stillisano, Jacqueline R.; Waxman, Hersh C.

2013-01-01

The purpose of this mixed-methods study was to evaluate the efficacy of 14 Mathematics, Science and Technology Teacher Preparation (MSTTP) academies located across the state of Texas. The aim of the academies was to increase the number of highly qualified mathematics, science and technology teachers, while also improving the quality of certified…

Self-Efficacy, Self-Evaluation, and Music Performance of Secondary-Level Band Students

ERIC Educational Resources Information Center

Hewitt, Michael P.

2015-01-01

In the present study, relationships between two components of self-regulation (self-efficacy and self-evaluation) and gender, school level, instrument family, and music performance were examined. Participants were 340 middle and high school band students who participated in one of two summer music camps or who were members of a private middle…

Cognitive-Behavioral Therapy for Comorbid Generalized Anxiety Disorder and Panic Disorder with Agoraphobia

ERIC Educational Resources Information Center

Labrecque, Joane; Dugas, Michel J.; Marchand, Andre; Letarte, Andree

2006-01-01

The goal of this study was to evaluate the efficacy of a cognitive-behavioral treatment package for comorbid generalized anxiety disorder (GAD) and panic disorder with agoraphobia (PDA). A single-case, multiple-baseline, across-subjects design was used with 3 primary GAD patients with secondary PDA. The efficacy of the treatment was evaluated with…

An Evaluation of a School-Based Professional Development Program on Teachers' Efficacy for Technology Integration: Findings from an Initial Study

ERIC Educational Resources Information Center

Skoretz, Yvonne; Childress, Ronald

2013-01-01

The purpose of this program evaluation was to determine the impact of a school-based, job-embedded professional development program on elementary and middle school teacher efficacy for technology integration. Participant bi-weekly journal postings were analyzed using Grappling's "Technology and Learning Spectrum" (Porter, 2001) to…

Efficacy of Eight Months of Nightly Zolpidem: A Prospective Placebo-Controlled Study

PubMed Central

Randall, Surilla; Roehrs, Timothy A.; Roth, Thomas

2012-01-01

Study Objectives: To evaluate the long-term (8 months) efficacy of zolpidem in adults with chronic primary insomnia using polysomnography. Design: Randomized, double-blind, placebo-controlled clinical trial. Setting: Sleep disorders and research center. Participants: Healthy participants (n = 91), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia. Interventions: Nightly zolpidem, 10 mg (5 mg for patients > 60 yrs) or placebo 30 minutes before bedtime for 8 months. Measurements and Results: Polysomnographic sleep parameters and morning subject assessments of sleep on 2 nights in months 1 and 8. Relative to placebo, zolpidem significantly increased overall total sleep time and sleep efficiency, reduced sleep latency and wake after sleep onset when assessed at months 1 and 8. Overall, subjective evaluations of efficacy were not shown among treatment groups. Conclusions: In adults with primary insomnia, nightly zolpidem administration remained efficacious across 8 months of nightly use. Clinical Trial Information: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525. Citation: Randall S; Roehrs TA; Roth T. Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study. SLEEP 2012;35(11):1551-1557. PMID:23115404

Residual efficacy of pyriproxyfen and Hydroprene applied to wood, metal, and concrete for control of stored-product insects

USDA-ARS?s Scientific Manuscript database

Pyriproxyfen and hydroprene are insect growth regulators (IGRs) that have been evaluated to control insect pests of field crops, but there are limited reports of efficacy against stored-product insects. A laboratory study was conducted to determine residual efficacy of pyriproxyfen and hydroprene on...

Evaluating High School Students' Anxiety and Self-Efficacy towards Biology

ERIC Educational Resources Information Center

Çimen, Osman; Yilmaz, Mehmet

2015-01-01

Anxiety and self-efficacy are among the factors that impact students' performance in biology. The current study aims to investigate high school students' perception of biology anxiety and self-efficacy, in relation to gender, grade level, interest in biology, negative experience associated with biology classes, and teachers' approaches in the…

Effects of a Rape Awareness Program on College Women: Increasing Bystander Efficacy and Willingness to Intervene

ERIC Educational Resources Information Center

Foubert, John D.; Langhinrichsen-Rohling, Jennifer; Brasfield, Hope; Hill, Brent

2010-01-01

An experimental study evaluated the efficacy of a sexual assault risk-reduction program on 279 college women that focused on learning characteristics of male perpetrators and teaching bystander intervention techniques. After seeing The Women's Program, participants reported significantly greater bystander efficacy and significantly greater…

Elementary Pre-Service Teachers' Response-Shift Bias: Self-Efficacy and Attitudes toward Science

ERIC Educational Resources Information Center

Cartwright, Tina J.; Atwood, Jon

2014-01-01

Response-shift bias occurs when participants' initial constructs, such as self-efficacy in teaching science, are incomplete because they do not fully conceptualize something they have yet to experience. This study examines whether elementary pre-service teachers can consistently evaluate constructs such as self-efficacy and attitudes toward…

The Construction and Initial Validation of the "Student Teachers' Efficacy Scale for Teaching Students with Disabilities"

ERIC Educational Resources Information Center

Zhang, Dake; Wang, Qiu; Stegall, Joanna; Losinki, Mickey; Katsiyannis, Antonis

2018-01-01

Although there have been numerous instruments for assessing teacher efficacy in teaching general education students, there is a need to develop and validate an instrument that specifically assesses teachers' efficacy in teaching students with disabilities. This study constructed and evaluated the psychometric properties of the "Student…

An Examination of Elementary Math Anxiety, Self-Efficacy, and Academic Achievement

ERIC Educational Resources Information Center

McMillian, Kimberley Suzanne

2017-01-01

The study aims to explore the level of suburban 5th grade students' mathematics self-efficacy, math anxiety, and academic achievement, to discover the possible interconnections between these parameters. The measures used to evaluate each included the Math Anxiety Rating Scale, the Self-Efficacy Questionnaire, and the North Carolina End of Grade…

Academic Support Services and Career Decision-Making Self-Efficacy in Student Athletes

ERIC Educational Resources Information Center

Burns, Gary N.; Jasinski, Dale; Dunn, Steve; Fletcher, Duncan

2013-01-01

This study examined the relationship between evaluations of academic support services and student athletes' career decision-making self-efficacy. One hundred and fifty-eight NCAA athletes (68% male) from 11 Division I teams completed measures of satisfaction with their academic support services, career decision-making self-efficacy, general…

An Integrative Review of Self-Efficacy Measurement Instruments in Youth with Type 1 Diabetes (T1DM)

PubMed Central

Rasbach, Lisa; Jenkins, Carolyn; Laffel, Lori

2014-01-01

Purpose The purpose of this study is to assess the extant literature on instruments used to measure self-efficacy in youth with type 1 diabetes (T1DM) and their caregivers and to critically evaluate these measurements. Methods An integrative review (2003–2013) was conducted searching PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and U.S. National Library of Medicine PubMed service (PubMed) databases using key words diabetes, type 1 diabetes, and self-efficacy. The authors reviewed the resulting294 references for inclusion criteria of (a) sample of youth with T1DM or sample of caregivers of youth with T1DM, (b) description of the self-efficacy instrument as primary research, and (c) the instrument measured self-efficacy specifically related to diabetes management. Forty-five articles out of the initial 294 met criteria. Results Of the 45 articles, 10 different self-efficacy instruments were identified. The primary theoretical framework used was Bandura’s social cognitive theory and model of self-efficacy. Most participants were white middle class T1DM youth. Evaluations to assess validity often were not reported; however, a majority of studies reported high internal consistency of the instruments. Conclusions Sample homogeneity could limit the applicability of results to certain patient populations. Further psychometric analysis, including validity assessments, should be conducted in more diverse samples. Development of valid and reliable instruments for measuring self-efficacy that are sensitive to change across a wider caregiver base over time is necessary. While this review examined reliable and valid instruments used in research, future opportunities include evaluation of measuring self-efficacy in T1DM youth exposed to recent advances in diabetes management technologies. PMID:25216655

Blind Biobanking of the Prostatectomy Specimen: Critical Evaluation of the Existing Techniques and Development of the New 4-Level Tissue Extraction Model With High Sampling Efficacy.

PubMed

Tolkach, Yuri; Eminaga, Okyaz; Wötzel, Fabian; Huss, Sebastian; Bettendorf, Olaf; Eltze, Elke; Abbas, Mahmoud; Imkamp, Florian; Semjonow, Axel

2017-03-01

Fresh tissue is mandatory to perform high-quality translation studies. Several models for tissue extraction from prostatectomy specimens without guidance by frozen sections are already introduced. However, little is known about the sampling efficacy of these models, which should provide representative tissue in adequate volumes, account for multifocality and heterogeneity of tumor, not violate the routine final pathological examination, and perform quickly without frozen section-based histological control. The aim of the study was to evaluate the sampling efficacy of the existing tissue extraction models without guidance by frozen sections ("blind") and to develop an optimized model for tissue extraction. Five hundred thirty-three electronic maps of the tumor distribution in prostates from a single-center cohort of the patients subjected to radical prostatectomy were used for analysis. Six available models were evaluated in silico for their sampling efficacy. Additionally, a novel model achieving the best sampling efficacy was developed. The available models showed high efficacies for sampling "any part" from the tumor (up to 100%), but were uniformly low in efficacy to sample all tumor foci from the specimens (with the best technique sampling only 51.6% of the all tumor foci). The novel 4-level extraction model achieved a sampling efficacy of 93.1% for all tumor foci. The existing "blind" tissue extraction models from prostatectomy specimens without frozen sections control are suitable to target tumor tissues but these tissues do not represent the whole tumor. The novel 4-level model provides the highest sampling efficacy and a promising potential for integration into routine. Prostate 77: 396-405, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

[Development and evaluation of the Empowering A Self-Efficacy (EASE) program for children with epilepsy].

PubMed

Yoo, Hana; Kim, Hee-Soon

2015-02-01

The purpose of this study was to verify effects of the Empowering A Self-Efficacy (EASE) program on self-efficacy, self-management, and child attitude toward illness in children with epilepsy. This was a quasi-experimental study with a non-equivalent control group pre-post test design. Participants were 10 to 15 year old children with epilepsy (11 in the experimental group and 10 in the control group) who were registered at one hospital in S city. The experimental group received the EASE program for 3 weeks. In the first week, a group meeting lasting 570 minutes was conducted on a single day. Over the next two weeks, telephone counselling was conducted twice a week. Data were analyzed using SPSS 18.0. There was a significant difference of pre-post evaluation of the epilepsy self-management scores in the experimental group. However, differences between the experimental group and the control group for seizure self-efficacy and child attitude toward illness were not significant. This is the first study in Korea to develop and evaluate an intervention program for children with epilepsy. Further studies are needed to confirm the effects of the EASE program.

Parameters for defining efficacy in fracture healing

PubMed Central

Shisha, Tamas

2010-01-01

Complications of the bone-healing process, especially in elderly, osteoporotic patients, are cause of important medical and economical burden. At the same time, there is no clinical study today to have shown the efficacy of a pharmacological treatment to enhance fracture repair. The author analyzes the potential criteria that could be used for the evaluation of treatment efficacy to enhance fracture healing in the frame of a clinical study. PMID:22461284

Time and dose-dependence evaluation of nitroheterocyclic drugs for improving efficacy following Trypanosoma cruzi infection: A pre-clinical study.

PubMed

Mazzeti, Ana Lia; Diniz, Lívia de F; Gonçalves, Karolina R; Nascimento, Alvaro F S; Spósito, Pollyanna A F; Mosqueira, Vanessa C F; Machado-Coelho, George L L; Ribeiro, Isabela; Bahia, Maria T

2018-02-01

Benznidazole and nifurtimox-treatments regimens currently used in human are supported by very limited experimental data. This study was designed to evaluate the time and dose dependence for efficacy of the most important nitroheterocyclic drugs in use for Chagas disease. In order to evaluate time dependence, Y strain-infected mice received benznidazole for a total of 1, 3, 7, 10, 20, and 40 days. Treatment courses of 3-10-day were effective in clearing parasitaemia and suppressing mortality, but parasitological cure was not achieved. Extending the treatments to 20 or 40 days clearly improved benznidazole efficacy. The 20-day treatment induced cure in 57.1% of Y strain infections (partially drug resistant) but failed to cure Colombian strain infections (full drug resistant), while the 40-day treatment resulted in cure of 100% of Y and 50% of Colombian strain infected mice. The increased cure rates in T. cruzi infected animals that received nifurtimox for 40 days confirm the relationship between the length of treatment and efficacy. An improvement in efficacy was observed with increasing benznidazole doses; cure was verified in 28.6% (75 mg/kg), 57.1% (100 mg/kg) and 80% (300 mg/kg). Overall, these nonclinical study data provide evidence that the efficacy of benznidazole is dose and time dependent. These findings may be relevant for optimizing treatment of human Chagas disease. Copyright © 2018 Elsevier Inc. All rights reserved.

A systematic review of three approaches for constructing physical activity messages: What messages work and what improvements are needed?

PubMed Central

2010-01-01

Background To motivate individuals to adhere to a regular physical activity regime, guidelines must be supplemented with persuasive messages that are disseminated widely. While substantial research has examined effective strategies for disseminating physical activity messages, there has been no systematic effort to examine optimal message content. This paper reviews studies that evaluate the effectiveness of three approaches for constructing physical activity messages including tailoring messages to suit individual characteristics of message recipients (message tailoring), framing messages in terms of gains versus losses (message framing), and targeting messages to affect change in self-efficacy (i.e., a theoretical determinant of behavior change). Methods We searched the MEDLINE, PsycINFO, EMBASE and CINAHL databases up to July 2008. Relevant reference lists also were searched. We included intervention trials, field experiments, and laboratory-based studies that aimed to test the efficacy or effectiveness of tailored messages, framed messages and self-efficacy change messages among healthy adults. We used a descriptive approach to analyze emerging patterns in research findings. Based on this evidence we made recommendations for practice and future research. Results Twenty-two studies were identified. Twelve studies evaluated message tailoring. In 10 of these studies, tailored messages resulted in greater physical activity than a control message. Six studies evaluated framed messages. Five of these studies demonstrated that gain-framed messages lead to stronger intentions to be active compared to a control message. Moreover, a gain-frame advantage was evident in three of the four studies that assessed physical activity. Four studies evaluated self-efficacy change messages. The two studies that used an experimental design provide a clear indication that individuals' beliefs can be affected by messages that incorporate types of information known to be determinants of self-efficacy. Overall, strong evidence to support definitive recommendations for optimal message content and structure was lacking. Conclusions Additional research testing the optimal content of messages used to supplement physical activity guidelines is needed. Tailored messages, gain-framed messages, and self-efficacy change messages hold promise as strategies for constructing physical activity messages and should be a focus of future research. PMID:20459779

Preparation and characterization of oxybenzone-loaded gelatin microspheres for enhancement of sunscreening efficacy.

PubMed

Patel, M; Jain, Sunil K; Yadav, Awesh K; Gogna, D; Agrawal, G P

2006-01-01

The objective of our present study was to prepare and evaluate gelatin microspheres of oxybenzone to enhance its sunscreening efficacy. The gelatin microspheres of oxybenzone were prepared by emulsion method. Process parameters were analyzed to optimize the formulation. The in vitro drug release study was performed in pH 7.4 using cellulose acetate membrane. Microspheres prepared using oxybenzone:gelatin ratio of 1:6 showed slowest drug release and those prepared with oxybenzone:gelatin ratio of 1:2 showed fastest drug release. The gelatin microspheres of oxybenzone were incorporated in aloe vera gel. Sun exposure method using sodium nitroprusside solution was used for in vitro sunscreen efficacy testing. The formulation C5 containing oxybenzone-bearing gelatin microspheres in aloe vera gel showed best sunscreen efficacy. The formulations were evaluated for skin irritation test in human volunteers, sun protection factor, and minimum erythema dose in albino rats. These studies revealed that the incorporation of sunscreening agent-loaded microspheres into aloe vera gel greatly increased the efficacy of sunscreen formulation more than four times.

Mediated-Efficacy: Hope for "Helpless" Writers

ERIC Educational Resources Information Center

Camfield, Eileen Kogl

2016-01-01

Building on previous studies of college students' writing self-efficacy beliefs, this article presents the empirical foundation for a reconceptualized understanding of this identity process. The study assessed 131 college freshmen enrolled in a developmental writing course who were evaluated holistically using grounded theory methodology. The…

Development of a program logic model and evaluation plan for a participatory ergonomics intervention in construction.

PubMed

Jaegers, Lisa; Dale, Ann Marie; Weaver, Nancy; Buchholz, Bryan; Welch, Laura; Evanoff, Bradley

2014-03-01

Intervention studies in participatory ergonomics (PE) are often difficult to interpret due to limited descriptions of program planning and evaluation. In an ongoing PE program with floor layers, we developed a logic model to describe our program plan, and process and summative evaluations designed to describe the efficacy of the program. The logic model was a useful tool for describing the program elements and subsequent modifications. The process evaluation measured how well the program was delivered as intended, and revealed the need for program modifications. The summative evaluation provided early measures of the efficacy of the program as delivered. Inadequate information on program delivery may lead to erroneous conclusions about intervention efficacy due to Type III error. A logic model guided the delivery and evaluation of our intervention and provides useful information to aid interpretation of results. © 2013 Wiley Periodicals, Inc.

Development of a Program Logic Model and Evaluation Plan for a Participatory Ergonomics Intervention in Construction

PubMed Central

Jaegers, Lisa; Dale, Ann Marie; Weaver, Nancy; Buchholz, Bryan; Welch, Laura; Evanoff, Bradley

2013-01-01

Background Intervention studies in participatory ergonomics (PE) are often difficult to interpret due to limited descriptions of program planning and evaluation. Methods In an ongoing PE program with floor layers, we developed a logic model to describe our program plan, and process and summative evaluations designed to describe the efficacy of the program. Results The logic model was a useful tool for describing the program elements and subsequent modifications. The process evaluation measured how well the program was delivered as intended, and revealed the need for program modifications. The summative evaluation provided early measures of the efficacy of the program as delivered. Conclusions Inadequate information on program delivery may lead to erroneous conclusions about intervention efficacy due to Type III error. A logic model guided the delivery and evaluation of our intervention and provides useful information to aid interpretation of results. PMID:24006097

Evaluation of standardized sample collection, packaging, and ...

EPA Pesticide Factsheets

Journal Sample collection procedures and primary receptacle (sample container and bag) decontamination methods should prevent contaminant transfer between contaminated and non-contaminated surfaces and areas during bio-incident operations. Cross-contamination of personnel, equipment, or sample containers may result in the exfiltration of biological agent from the exclusion (hot) zone and have unintended negative consequences on response resources, activities and outcomes. The current study was designed to: (1) evaluate currently recommended sample collection and packaging procedures to identify procedural steps that may increase the likelihood of spore exfiltration or contaminant transfer; (2) evaluate the efficacy of currently recommended primary receptacle decontamination procedures; and (3) evaluate the efficacy of outer packaging decontamination methods. Wet- and dry-deposited fluorescent tracer powder was used in contaminant transfer tests to qualitatively evaluate the currently-recommended sample collection procedures. Bacillus atrophaeus spores, a surrogate for Bacillus anthracis, were used to evaluate the efficacy of spray- and wipe-based decontamination procedures.

[The relationship between academic self-efficacy and academic burnout in medical students].

PubMed

Lee, Su Hyun; Jeon, Woo Taek

2015-03-01

The purpose of this study was to examine the correlation between academic burnout and academic self-efficacy in medical students. The study group comprised 446 students in years 1 to 4 of medical school. They were asked to rate their academic burnout and academic self-efficacy on a scale. The data were analyzed by multivariate analysis of variance and regression analysis. Academic self-efficacy was correlated negatively with academic burnout explaining 37% of academic burnout. Academic self-efficacy (especially self-confidence) had the greatest effect on academic burnout. The implications of these results are discussed in terms of an evaluation and support system for students.

Clinical evaluation of the safety and efficacy of 10% imidacloprid + 2.5% moxidectin topical solution for the treatment of ear mite (Otodectes cynotis) infestations in dogs.

PubMed

Arther, R G; Davis, W L; Jacobsen, J A; Lewis, V A; Settje, T L

2015-05-30

A clinical field investigation was conducted to evaluate the safety and efficacy of 10% imidacloprid/2.5% moxidectin for the treatment of ear mites (Otodectes cynotis) in dogs. The study was a multi-centered, blinded, positive controlled, randomized clinical trial conducted under field conditions with privately owned pets. A total of 17 veterinary clinics enrolled cases for the study. An otoscopic examination was performed to confirm the presence of O. cynotis residing in the ear of the dog prior to enrollment. A single-dog household was enrolled in the study if the dog had 5 or more ear mites and an acceptable physical examination. A multi-dog household was eligible if at least one dog in the household had 5 or more mites and all dogs in the household had acceptable physical exams and met the inclusion criteria. Qualified households were randomly assigned to treatments to receive either 10% imidacloprid+2.5% moxidectin topical solution or topical selamectin solution (positive control product) according to a pre-designated enrollment ratio of 2:1, respectively. If more than one dog in a multiple dog household had adequate numbers of ear mites, one dog was randomly selected to represent the household for efficacy evaluation prior to treatment. Treatments were administered twice per label and dose banding directions for each product approximately 28 days apart (Days 0 and 28), by the dog's owner at the study site. All dogs in a household were treated on the same day and with the same product. The owners completed a post-treatment observation form one day after each treatment. Post-treatment otoscopic examinations were performed by the investigators or attending veterinarian on Days 28 and 56. Physical examinations were performed on Days 0 and 56. One hundred and four (104) households were evaluated for efficacy on SD 28, and 102 households were evaluated for efficacy on SD 56. The dogs' ages ranged from 2 months to 16 years. A total of 247 dogs were evaluated for safety. Percent efficacy was based on the percentage of dogs cleared of ear mites. Mite clearance on Day 28 was 71% for the imidacloprid+moxidectin group and 69% for the selamectin group. Mite clearance on Day 56 was 82% for the imidacloprid+moxidectin group and 74% for the selamectin group. No serious adverse events associated with either product were observed during the study. The study demonstrated that 10% imidacloprid+2.5% moxidectin applied using two topical treatments, 28 days apart, was safe and achieved similar efficacy against O. cynotis as selamectin treatments applied and evaluated under the same conditions. Copyright © 2015 Elsevier B.V. All rights reserved.

Evaluation of the Efficacy of a Dental Plaque Control Program in Autistic Patients

ERIC Educational Resources Information Center

Dias, Guilherme G.; Prado, Eliane F. G. B.; Vadasz, Estevao; Siqueira, Jose Tadeu T.

2010-01-01

The aim of this study was to verify the efficacy of a programme for dental plaque control in autistics. Patients were evaluated on five occasions over a period of 180 days using the following instruments: OHI-S, DMF-T, the Fonnes brushing technique and diet questionnaire. Participants were divided into two groups according to level of co-operation…

Latent Profiles of Parental Self-Efficacy and Children's Multisource-Evaluated Social Competence

ERIC Educational Resources Information Center

Junttila, Niina; Vauras, Marja

2014-01-01

Background: The interrelation between mothers' parental self-efficacy (PSE) and their school-aged children's well-being has been repeatedly proved. The lack of research in this area situates mainly on the absence of fathers, non-existent family-level studies, the paucity of independent evaluators, and the use of global PSE estimates.…

Efficacy of budesonide in collagenous colitis Evaluation of: Miehlke S, Madisch A, Kupcinskas L, et al. Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis. Gastroenterology 2014;146(5):1222-1230 e1222.

PubMed

Drug, Vasile L; Antoniu, Sabina A

2014-10-01

Collagenous colitis (CC) is a less common colonic disease with variable prevalence and undulating course. Among the available therapies, budesonide was demonstrated to induce a rapid and sustained remission in many cases, but little is known about the comparative efficacy of other treatments, such as mesalamine. Evaluation of a randomized study assessing the efficacy and safety of budesonide over mesalamine in patients with CC. Data from the study showed that budesonide was significantly superior to placebo and to mesalamine and further supports the recommendation of the current guidelines on the use of budesonide in CC. However, other forms of mesalamine may further be evaluated for this disease.

Item Response Modeling: An Evaluation of the Children's Fruit and Vegetable Self-Efficacy Questionnaire

ERIC Educational Resources Information Center

Watson, Kathy; Baranowski, Tom; Thompson, Debbe

2006-01-01

Perceived self-efficacy (SE) for eating fruit and vegetables (FV) is a key variable mediating FV change in interventions. This study applies item response modeling (IRM) to a fruit, juice and vegetable self-efficacy questionnaire (FVSEQ) previously validated with classical test theory (CTT) procedures. The 24-item (five-point Likert scale) FVSEQ…

Item response modeling: A psychometric assessment of the children's fruit, vegetable, water, and physical activity self-efficacy scales among Chinese children

USDA-ARS?s Scientific Manuscript database

This study aimed to evaluate the psychometric properties of four self-efficacy scales (i.e., self-efficacy for fruit (FSE), vegetable (VSE), and water (WSE) intakes, and physical activity (PASE)) and to investigate their differences in item functioning across sex, age, and body weight status groups ...

Human Patient Simulations: Evaluation of Self-Efficacy and Anxiety in Clinical Skills Performance

ERIC Educational Resources Information Center

Onovo, Grace N.

2013-01-01

The relationship between self-efficacy (self-confidence) and anxiety levels, and the use of Human Patient Simulations (HPS) as a teaching-learning strategy, has not been sufficiently studied in the area of clinical nursing education. Despite the evidence in the literature indicating that HPS increases self-efficacy/self-confidence and decreases…

Self-Efficacy Scale for Weight Loss among Multi-Ethnic Women of Lower Income: A Psychometric Evaluation

ERIC Educational Resources Information Center

Latimer, Lara; Walker, Lorraine O.; Kim, Sunghun; Pasch, Keryn E.; Sterling, Bobbie Sue

2011-01-01

Objective: This study examined test-retest reliability, internal consistency, and construct and predictive validity of the Physical Activity and Nutrition Self-Efficacy (PANSE) scale, an 11-item instrument to assess weight-loss self-efficacy among postpartum women of lower income. Methods: Seventy-one women completed the PANSE scale and…

Inclusive Education in Japan and Korea--Japanese and Korean Teachers' Self-Efficacy and Attitudes towards Inclusive Education

ERIC Educational Resources Information Center

Song, Jia

2016-01-01

The current study aims to evaluate teachers' self-efficacy and attitudes towards inclusive classrooms in Japan and Korea. Teachers' Sense of Efficacy Scale (TSES; Tschannen-Moran and Woolfolk, [Tschannen-Moran, M., 2001]) and Scale of Teachers' Attitudes Towards Inclusive Classrooms (STATIC; Cochran, [Cochran, H., 1998]) were completed by 191…

Susceptibility of different life stages of Tribolium confusum to pyrethrin aerosol: effects of a flour food source on insecticidal efficacy

USDA-ARS?s Scientific Manuscript database

Accumulated grain dust and flour residues in flour mills can potentially decrease the efficacy of contact insecticides used for control of adult and immature stages of stored product insects. A study was conducted to evaluate the effects of flour residues on the efficacy of synergized pyrethrin aero...

Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial.

PubMed

Friedman, A J; Wheeler, J

1991-04-01

A phase IV trial evaluated the efficacy and safety of a monophasic oral contraceptive formulation, ethynodiol diacetate, 1 mg, plus ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) (Demulen 1/35). Nine hundred eighty-three community-based obstetrician-gynecologists treated a total of 7,759 patients with EDA 1 mg with EE 35 micrograms for one to eight months. Clinical evaluation forms on 6,382 patients were amenable to analysis for safety (including breakthrough bleeding, ovarian cyst formation and complexion changes); 5,412 patients were evaluable for efficacy (prevention of pregnancy), with a total of 21,440 cycles recorded. The study results were interpreted in terms of the impact on clinical management of oral contraceptive users and the methods, strengths and weaknesses of phase IV trials, particularly as they relate to confirmation of the results reported here.

Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-‘Tabac Info Service’: ee-TIS trial

PubMed Central

Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F

2017-01-01

Introduction A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. Methods and analyses The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. Ethics and dissemination The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. Trial registration number NCT02841683; Pre-results. PMID:28237958

Tolerance and efficacy of emamectin benzoate and ivermectin for the treatment of Pseudocapillaria tomentosa in laboratory zebrafish (Danio rerio).

PubMed

Collymore, Chereen; Watral, Virginia; White, Julie R; Colvin, Michael E; Rasmussen, Skye; Tolwani, Ravi J; Kent, Michael L

2014-10-01

Tolerance of adult zebrafish and efficacy of emamectin benzoate and ivermectin in eliminating Pseudocapillaria tomentosa infection were evaluated. In the tolerance study, behavioral changes, fecundity, histopathology, and mortality were evaluated for in-feed administration of emamectin (0.05, 0.10, and 0.25 mg/kg) and ivermectin (0.05 and 0.10 mg/kg). All doses of emamectin were well tolerated. Ivermectin 0.05 mg/kg administration resulted in mild behavioral changes and a transient decrease in fecundity. Ivermectin 0.10 mg/kg administration resulted in severe behavioral changes and some mortality. In the efficacy study, emamectin (0.05 and 0.25 mg/kg) and ivermectin (0.05 mg/kg) were evaluated for their efficacy in eliminating P. tomentosa infection. Emamectin reduced parasite burden in infected zebrafish, and ivermectin eliminated intestinal nematode infections. Despite a small margin of safety, ivermectin 0.05 mg/kg was effective at eliminating P. tomentosa infection in adult zebrafish. Higher doses or a longer course of treatment may be needed for complete elimination of P. tomentosa infection using emamectin. In this study, we propose two possible treatments for intestinal nematode infections in zebrafish.

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 of isoniazid prophylactic therapy in prevention of tuberculosis in children: a meta–analysis

PubMed Central

2014-01-01

Background Children are highly susceptible to tuberculosis; thus, there is need for safe and effective preventive interventions. Our objective was to evaluate the efficacy of isoniazid in prevention of tuberculosis morbidity and mortality in children aged 15 years or younger by performing a meta-analysis of randomized controlled trials. To our knowledge, this is the first meta-analysis evaluating efficacy of isoniazid prophylaxis in prevention of tuberculosis in children. Methods A systematic search of the literature was done to identify randomized controlled trials evaluating isoniazid prophylaxis efficacy among children. Each study was evaluated for relevance and validity for inclusion in the analysis. Subgroup analyses were conducted based on study quality, HIV status, tuberculosis endemicity, type of prophylaxis and age of participants. Results Eight studies comprising 10,320 participants were included in this analysis. Upon combining data from all eight studies, isoniazid prophylaxis was found to be efficacious in preventing development of tuberculosis, with a pooled RR of 0.65 (95% CI 0.47, 0.89) p = 0.004 , with confidence intervals adjusted for heterogeneity. Among the sub-group analyses conducted, only age of the participants yielded dramatic differences in the summary estimate of efficacy, suggesting that age might be an effect modifier of the efficacy of isoniazid among children, with no effect realised in children initiating isoniazid at four months of age or earlier and an effect being present in older children. Excluding studies in which isoniazid was initiated at four months of age or earlier yielded an even stronger effect (RR = 0.41 (95% CI 0.31, 0.55) p <0.001). Data on the effect of isoniazid on all-cause mortality, excluding studies in which isoniazid was initiated in infants, yielded an imprecise estimate of mortality benefit (RR = 0.58 (95% CI 0.31, 1.09) p = 0.092). Conclusion Isoniazid prophylaxis reduces the risk of developing tuberculosis by 59% among children aged 15 years or younger excluding children initiated during early infancy for primary prophylaxis (RR = 0.41, 95% CI 0.31, 0.55 p < 0.001) . However, further studies are needed to assess effects on mortality and to determine prophylaxis effectiveness in very young children and among HIV-infected children. PMID:24555539

[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.

Development and psychometric evaluation of an information literacy self-efficacy survey and an information literacy knowledge test.

PubMed

Tepe, Rodger; Tepe, Chabha

2015-03-01

To develop and psychometrically evaluate an information literacy (IL) self-efficacy survey and an IL knowledge test. In this test-retest reliability study, a 25-item IL self-efficacy survey and a 50-item IL knowledge test were developed and administered to a convenience sample of 53 chiropractic students. Item analyses were performed on all questions. The IL self-efficacy survey demonstrated good reliability (test-retest correlation = 0.81) and good/very good internal consistency (mean κ = .56 and Cronbach's α = .92). A total of 25 questions with the best item analysis characteristics were chosen from the 50-item IL knowledge test, resulting in a 25-item IL knowledge test that demonstrated good reliability (test-retest correlation = 0.87), very good internal consistency (mean κ = .69, KR20 = 0.85), and good item discrimination (mean point-biserial = 0.48). This study resulted in the development of three instruments: a 25-item IL self-efficacy survey, a 50-item IL knowledge test, and a 25-item IL knowledge test. The information literacy self-efficacy survey and the 25-item version of the information literacy knowledge test have shown preliminary evidence of adequate reliability and validity to justify continuing study with these instruments.

Development and psychometric evaluation of an information literacy self-efficacy survey and an information literacy knowledge test*

PubMed Central

Tepe, Rodger; Tepe, Chabha

2015-01-01

Objective To develop and psychometrically evaluate an information literacy (IL) self-efficacy survey and an IL knowledge test. Methods In this test–retest reliability study, a 25-item IL self-efficacy survey and a 50-item IL knowledge test were developed and administered to a convenience sample of 53 chiropractic students. Item analyses were performed on all questions. Results The IL self-efficacy survey demonstrated good reliability (test–retest correlation = 0.81) and good/very good internal consistency (mean κ = .56 and Cronbach's α = .92). A total of 25 questions with the best item analysis characteristics were chosen from the 50-item IL knowledge test, resulting in a 25-item IL knowledge test that demonstrated good reliability (test–retest correlation = 0.87), very good internal consistency (mean κ = .69, KR20 = 0.85), and good item discrimination (mean point-biserial = 0.48). Conclusions This study resulted in the development of three instruments: a 25-item IL self-efficacy survey, a 50-item IL knowledge test, and a 25-item IL knowledge test. The information literacy self-efficacy survey and the 25-item version of the information literacy knowledge test have shown preliminary evidence of adequate reliability and validity to justify continuing study with these instruments. PMID:25517736

Evaluating the Efficacy of a Short Aging Simulation Workshop for an Interdisciplinary Group of Health-Care Employees at a Veterans Affairs Medical Center

ERIC Educational Resources Information Center

Halpin, Sean N.

2015-01-01

Several interventions aimed at increasing positive attitudes towards older adults among health-care professionals have been introduced. These interventions tend to focus on a small subset of clinical employees, ignoring other clinical and nonclinical hospital staff. The objective of this study was to evaluate the efficacy of a short aging…

One-Year Efficacy Testing of Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial

ERIC Educational Resources Information Center

Knowlden, Adam; Sharma, Manoj

2016-01-01

Background: The purpose of this study was to evaluate the efficacy of the Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) intervention at 1-year, postintervention follow-up. Method: A mixed between-within subjects design was used to evaluate the trial. Independent variables included a…

The Development and Evaluation of an Achievement Test for Measuring the Efficacy of Task-Based Writing Activities to Enhance Iranian EFL Learners' Reading Comprehension

ERIC Educational Resources Information Center

Nejad, Ferdows Mohsen; Khosravian, Fereshteh

2014-01-01

The present study examined the reliability of an achievement test to measure the efficacy of task-based writing activities to improve Iranian EFL learners' reading comprehension at the intermediate level in a private language institute in Ilam, Iran, namely Alefba language institute. To achieve the goal, the techniques for evaluating reliability…

Understanding Acid-Base Concepts: Evaluating the Efficacy of a Senior High School Student-Centred Instructional Program in Indonesia

ERIC Educational Resources Information Center

Rahayu, Sri; Chandrasegaran, A. L.; Treagust, David F.; Kita, Masakazu; Ibnu, Suhadi

2011-01-01

This study was a mixed quantitative-qualitative research to evaluate the efficacy of a designed student-centred instructional (DSCI) program for teaching about acids and bases. The teaching innovation was designed based on constructivist, hands-on inquiry and context-based approaches and implemented in seven 45-min lessons with a class of 36 grade…

Using Self-Efficacy as a Construct for Evaluating Science and Mathematics Methods Courses

NASA Astrophysics Data System (ADS)

Brand, Brenda R.; Wilkins, Jesse L. M.

2007-04-01

The focus of this study was elementary preservice teachers’ development as effective teachers of science and mathematics as influenced by their participation in elementary science and mathematics methods courses. Preservice teachers’ reports of factors that influenced their perception of their teaching abilities were analyzed according to Bandura’s (1994) 4 sources of efficacy: mastery experiences, vicarious experiences, social persuasion, and stress reduction. This investigation allowed the researchers to evaluate the courses based on these sources. The analysis indicated all 4 sources influenced preservice teachers’ teaching self-efficacy beliefs, with mastery experiences considered the most influential. Embedded within discussions of mastery experiences were references to the other sources of efficacy, which suggest an interrelationship between mastery experiences and the other sources.

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

Cognitive hypnotherapy with bulimia.

PubMed

Barabasz, Marianne

2012-04-01

Research on the efficacy of hypnosis in the treatment of bulimia nervosa has produced mixed findings. This is due in part to the interplay between the characteristics of people with bulimia and the wide variety of hypnosis interventions that have been employed. Several authors have noted that methodological limitations in hypnosis research often make evaluation of treatment efficacy difficult. Many of the studies extant provide insufficient information regarding the specifics of participants' hypnotizability, the hypnotic induction, or the hypnotic suggestion(s) employed. Such limitations preclude replication and clinical implementation. This article reviews the literature with replicable methodologies and discusses the implications for evaluating treatment efficacy.

Academic Self-Efficacy among Junior High School Students in Ghana: Evaluating Factor Structure and Measurement Invariance across Gender

ERIC Educational Resources Information Center

Ansong, David; Eisensmith, Sarah R.; Masa, Rainier D.; Chowa, Gina A.

2016-01-01

Self-efficacy is a universal construct, but few validated measures exist for researchers in developing countries to use in assessing youths' perceptions of their ability to achieve academic success. This study examined the cross-cultural suitability and psychometric properties of an academic self-efficacy scale (ASES) adapted for the Ghanaian…

Evaluating the Efficacy of a Pre-Kindergarten Program: Transitional Needs of Young Children between Systems of Care and Public Education

ERIC Educational Resources Information Center

Lausch, John Michael

2012-01-01

The purpose of this study was to determine the efficacy of a South Central Pennsylvania public school's pre-kindergarten program in preparing young children for the transition to kindergarten. Despite the growing interest in pre-kindergarten education, no researcher had yet seriously examined the efficacy of providing a minimal amount of…

Impact of Project Based Learning on Teacher Self-Efficacy in the Age of Common Core State Standards

ERIC Educational Resources Information Center

Hazelton, Marnie R.

2017-01-01

The purpose of this study was to evaluate whether the implementation of PBL in a high needs district had a positive impact on teacher self-efficacy, student engagement and student motivation. In general, the findings indicated that the implementation of PBL increased teacher self-efficacy and led to an increase in student motivation and…

Predictors of weight loss success. Exercise vs. dietary self-efficacy and treatment attendance.

PubMed

Byrne, Shannon; Barry, Danielle; Petry, Nancy M

2012-04-01

Pre-treatment diet and exercise self-efficacies can predict weight loss success. Changes in diet self-efficacy across treatment appear to be even stronger predictors than baseline levels, but research on changes in exercise self-efficacy is lacking. Using data from a pilot study evaluating tangible reinforcement for weight loss (N=30), we examined the impact of changes in diet and exercise self-efficacy on outcomes. Multiple regression analyses indicated that treatment attendance and changes in exercise self-efficacy during treatment were the strongest predictors of weight loss. Developing weight loss programs that foster the development of exercise self-efficacy may enhance participants' success. Published by Elsevier Ltd.

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.

[Effect of body image in adolescent orthodontic treatment].

PubMed

Minghui, Peng; Jing, Kang; Xiao, Deng

2017-10-01

This study was designed to probe the psychological factors adolescent orthodontic patients, the role of body image and self-esteem in the whole process of orthodontic treatment and the impact on the efficacy and satisfaction of orthodontic. Five hundred and twenty-eight patients were selected in this study. The Aesthetic Component of the Index of Orthodontic Treatment Need (IOTN-AC) , Rosenberg Self-Esteem Scale (SES), Negative Physical Self-General (NPS-G) and other body analysis scale study after orthodontic lasted 18-24 months were used to investigate the role of body image in adolescent orthodontic treatment. Esthetic evaluation of patients teeth after correction had been significantly improved, patient self-evaluation difference IOTN-AC doctor evaluation, Psychosocial Impact of Dental Aesthetics Questionnaire-tooth confidence, aesthetic concerns, psychological impact and social function were significantly improved. The improvement of the dental aesthetics component (T2 when doctors evaluate IOTN-AC) was positively correlated with the evaluation of the efficacy, and was significantly negatively correlated with the negative emotions of patients at baseline. Negative body image-dental dissatisfied-cognitive component and the affective component, the overall negative body image and negative emotions can predict patient satisfaction with treatment efficacy. Orthodontic treatment not only improves the self-aesthetic evaluation of adolescent patients, but also has a positive effect on the mental health of adolescent patients.

Open-label, randomized, multicenter, phase III study to evaluate the safety and efficacy of benzoyl peroxide gel in long-term use in patients with acne vulgaris: A secondary publication.

PubMed

Kawashima, Makoto; Nagare, Toshitaka; Katsuramaki, Tsuneo

2017-06-01

An open-label, randomized, multicenter study was conducted to evaluate the safety and efficacy of long-term use of 2.5% and 5% benzoyl peroxide (BPO) gels administrated once daily for 52 weeks to Japanese patients with acne vulgaris. The efficacy of the study drugs was evaluated by counting inflammatory lesions and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. In total, 458 subjects were included in the efficacy and safety analyses. The total lesion count, the efficacy end-point, was similarly changed both in the 2.5% and 5% BPO groups over the course of the study. The median rates of reduction from baseline to week 12 were approximately 65%. Thereafter, the counts were maintained at a reduced level without increasing until week 52. The median rates at week 52 were approximately 80%. Similar trends were observed for inflammatory and non-inflammatory lesion counts. Bacteriological evaluation indicated similar distribution of the minimum inhibitory concentration of each of the antibacterial drugs against Propionibacterium acnes between the values at baseline and at week 52, suggesting that long-term use did not result in changes in the drug sensitivity. The incidence of adverse events was 84.0% in the 2.5% BPO group and 87.2% in the 5% BPO group. Many of the adverse events occurred within the first month and were mild or moderate in severity and transient. The results suggest that both 2.5% and 5% BPO gels are effective and safe for long-term treatment of patients with acne vulgaris. © 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

[Correlation between facial nerve functional evaluation and efficacy evaluation of acupuncture treatment for Bell's palsy].

PubMed

Zhou, Zhang-ling; Li, Cheng-xin; Jiang, Yue-bo; Zuo, Cong; Cai, Yun; Wang, Rui

2012-09-01

To assess and grade facial nerve dysfunction according to the extent of facial paralysis in the clinical course of acupuncture treatment for Bell's palsy, and to observe the interrelationship between the grade, the efficacy and the period of treatment, as well as the effect on prognosis. The authors employed the House-Brackmann scale, a commonly used evaluation scale for facial paralysis motor function, and set standards for eye fissure and lips. According to the improved scale, the authors assessed and graded the degree of facial paralysis in terms of facial nerve dysfunction both before and after treatment. The grade was divided into five levels: mild, moderate, moderately severe, severe dysfunction and complete paralysis. The authors gave acupuncture treatment according to the state of the disease without artificially setting the treatment period. The observation was focused on the efficacy and the efficacy was evaluated throughout the entire treatment process. Fifty-three cases out of 68 patients with Bell's palsy were cured and the overall rate of efficacy was 97%. Statistically significant differences (P<0.01) were perceived among the efficacy of five levels of facial nerve dysfunction. Efficacy was correlated with the damage level of the disease (correlation coefficient r=0.423, P<0.01). The course of treatment also extended with the severity of facial nerve dysfunction (P<0.01). Differences exist in patients with Bell's palsy in terms of severity of facial nerve dysfunction. Efficacy is reduced in correlation with an increase in facial nerve dysfunction, and the period of treatment varies in need of different levels of facial nerve dysfunction. It is highly necessary to assess and grade patients before observation and treatment in clinical study, and choose corresponding treatment according to severity of damage of the disease.

[Is the cognitive-behavioural therapy an effective strategy also in the prevention of post partum depression? a critical review].

PubMed

Nardi, Bernardo; Laurenzi, Sabrina; Di Nicolò, Marzia; Bellantuono, Cesario

2012-01-01

The aim of this study was to evaluate the efficacy of cognitive-behavioural therapy (CBT) in the prevention of post partum depression (PPD) in pregnant women at risk. PubMed, Medline, PsychInfo, Embase, and the Cochrane Library databases were searched from January 1991 to June 2011 to review studies on the efficacy of CBT in the prevention of PD. The literature analyzed recommends that depression in pregnancy requires an efficient management to provide mother's symptoms relief as well as to prevent PD. While several studies demonstrated the efficacy of CBT in the treatment of PD, only a few controlled studies focused on its efficacy in the prevention of PD in women identified at risk during pregnancy. The efficacy of CBT in preventing PD in pregnant women at risk is supported by only a few studies, presenting some methodological flaws. Better designed trials are needed to strongly support the efficacy of such psychotherapeutic preventive strategy in women at risk for PD.

Determination of physical parameters associated with self-efficacy in patients with chronic mechanic low back pain.

PubMed

Duray, M; Yagci, N; Ok, N

2018-03-23

Self-efficacy that is associated with various pain-related disabilities such as chronic low back pain (LBP), should be questioned besides physical assessments. To investigate the physical factors associated with self-efficacy in patients with chronic mechanic LBP. One hundred nine patients diagnosed as chronic mechanic LBP (65 females, 44 males) between 20-50 years old were included to this study. The intensity of LBP was assessed by using a 10-cm Visual Analogue Scale. For musculoskeletal fitness measurement; muscle strength, muscle endurance, and flexibility tests were applied. Functional Reach Test for balance evaluation, Self-Efficacy Scale for self-efficacy measurement, Roland-Morris Disability Questionnaire for disability level evaluation were used. We found a moderate negative correlation between self-efficacy and pain intensity (r=-0.506); a negative and strong correlation between self-efficacy and disability level (r=-0.654) (p< 0.05). Self efficacy had a significant association with right (r= 0.265) and left (r= 0.290) lateral side bending flexibility (p< 0.05). According to multiple regression analysis results, it was found that disability level had a significant effect on self-efficacy (β=-2.014; p< 0.01). Poor musculoskeletal fitness and pain intensity may cause decreasing self-efficacy but the major determinant of decreased self-efficacy was low-back related disability scores.

Evaluating undergraduate nursing students' self-efficacy and competence in writing: Effects of a writing intensive intervention.

PubMed

Miller, Louise C; Russell, Cynthia L; Cheng, An-Lin; Skarbek, Anita J

2015-05-01

While professional nurses are expected to communicate clearly, these skills are often not explicitly taught in undergraduate nursing education. In this research study, writing self-efficacy and writing competency were evaluated in 52 nontraditional undergraduate baccalaureate completion students in two distance-mediated 16-week capstone courses. The intervention group (n = 44) experienced various genres and modalities of written assignments set in the context of evidence-based nursing practice; the comparison group (n = 8) received usual writing undergraduate curriculum instruction. Self-efficacy, measured by the Post Secondary Writerly Self-Efficacy Scale, indicated significant improvements for all self-efficacy items (all p's = 0.00). Writing competency, assessed in the intervention group using a primary trait scoring rubric (6 + 1 Trait Writing Model(®) of Instruction and Assessment), found significant differences in competency improvement on five of seven items. This pilot study demonstrated writing skills can improve in nontraditional undergraduate students with guided instruction. Further investigation with larger, culturally diverse samples is indicated to validate these results. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

[Sublingual immunotherapy in children. Immunotherapy Committee of the Spanish Society for Clinical Immunology and Pediatric Allergology].

PubMed

Lleonart, R; Muñoz, F; Eseverri, J L; Martínez-Cañabate, A; Tabar, A I; Pedemonte, C

2003-01-01

Sublingual immunotherapy is currently attracting growing interest because of its ease of administration and, according to previous studies, its infrequent and mild adverse effects. However, at least in children, the efficacy of this therapy has not been completely demonstrated. In addition, the mechanisms of action remain to be elucidated since few studies have been published and the results have been contradictory and sometimes inconclusive. For this reason, we performed a literature review through the MEDLINE database, selecting double-blind studies carried out in children. Only 10 studies meeting these requirements were retrieved. All the studies were performed by European researchers and nine were published in European journals. Efficacy was evaluated by clinical parameters and by reduction in medication use. The results on efficacy are not homogeneous, although most support the utility of this route of administration. Moreover, reports of allergens other than those used in these studies dust mites and grass pollens are lacking. In conclusion, further studies evaluating the efficacy of this therapy in children are required. Among the general population, if the efficacy of sublingual immunotherapy in the treatment of sensitization to hymenoptera venoms were demonstrated, as has been the case with subcutaneous immunotherapy, the utility of this route of administration would be definitively confirmed. Finally, sublingual immunotherapy could be used in children who have shown systemic reactions to subcutaneous immunotherapy or who refuse to undergo injections.

Self-Efficacy and Preparation of Scholarly Writing: Online Doctoral Coursework to Comprehensive Examination--a Mixed Method Study

ERIC Educational Resources Information Center

Thomas, Sonya C.

2013-01-01

Writing is seldom explicitly taught, most specifically, in academic and scholarly writing. Therefore, this mixed methods correlational phenomenology research study explored the correlation between self-efficacy perception and course room preparation for the comprehensive examination, APA standards in the course room, APA standards evaluation for…

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…

A Study of Pre-Service Information and Communication Teachers' Efficacy Levels for Analyzing and Responding to Cyberbullying Cases

ERIC Educational Resources Information Center

Kavuk, Melike; Bulu, Sanser; Keser, Hafize

2016-01-01

This case study was conducted to investigate efficacy levels of preservice Information and Communication Teachers' to identify, prevent and intervene to cyberbullying cases. Fifty participants were interviewed and 56 cyberbullying cases, which the participants experienced or witnessed, were collected to evaluate their cyberbullying readiness.…

Elementary and Secondary Teachers' Attitudes and Efficacy for Teaching English Language Learners in the Mainstream Classroom

ERIC Educational Resources Information Center

Mathis, Dawn L.

2017-01-01

The purpose of this study was to evaluate Elementary and Secondary teachers' attitudes, efficacy, and cultural proficiency with mainstream ELL students. This study further explored teachers' beliefs toward professional development, differentiating curriculum and instruction, and understanding language acquisition with mainstream ELL students. The…

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…

Efficacy of Parent-Child Interaction Therapy with Chinese ADHD Children: Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Cynthia; Tsang, Sandra; Ng, Gene S. H.; Choi, S. Y.

2017-01-01

Purpose: This study aimed to evaluate the efficacy of Parent-Child Interaction Therapy (PCIT) in Chinese children with attention-deficit/hyperactivity disorder (ADHD) or ADHD features. Methods: This study adopted a randomized controlled trial design without blinding. Participants were randomized into either the intervention group (n = 32) and…

The Efficacy of Drama in Field Experience: A Qualitative Study Using MAXQDA

ERIC Educational Resources Information Center

Elaldi, Senel; Yerliyurt, Nazli Sila

2017-01-01

This study attempted to evaluate the views of senior preservice preschool teachers on the efficacy of drama activities in their field experience in terms of the effect of students' learning, socialization, individual or group work skills and school connectedness and also disclosed the suggestions of senior preservice preschool teachers for faculty…

Auditory Processing Disorder and Auditory/Language Interventions: An Evidence-Based Systematic Review

ERIC Educational Resources Information Center

Fey, Marc E.; Richard, Gail J.; Geffner, Donna; Kamhi, Alan G.; Medwetsky, Larry; Paul, Diane; Ross-Swain, Deborah; Wallach, Geraldine P.; Frymark, Tobi; Schooling, Tracy

2011-01-01

Purpose: In this systematic review, the peer-reviewed literature on the efficacy of interventions for school-age children with auditory processing disorder (APD) is critically evaluated. Method: Searches of 28 electronic databases yielded 25 studies for analysis. These studies were categorized by research phase (e.g., exploratory, efficacy) and…

Rationale, Design, and Methods of the Preschool ADHD Treatment Study (PATS)

ERIC Educational Resources Information Center

Kollins, Scott; Greenhill, Laurence; Swanson, James; Wigal, Sharon; Abikoff, Howard; McCracken, James; Riddle, Mark; McGough, James; Vitiello, Benedetto; Wigal, Tim; Skrobala, Anne; Posner, Kelly; Ghuman, Jaswinder; Davies, Mark; Cunningham, Charles; Bauzo, Audrey

2006-01-01

Objective: To describe the rationale and design of the Preschool ADHD Treatment Study (PATS). Method: PATS was a National Institutes of Mental Health-funded, multicenter, randomized, efficacy trial designed to evaluate the short-term (5 weeks) efficacy and long-term (40 weeks) safety of methylphenidate (MPH) in preschoolers with…

The Differential Relationship of Feminist Attitudes and Feminist Identity to Self-Efficacy

ERIC Educational Resources Information Center

Eisele, Heather; Stake, Jayne

2008-01-01

Feminist theorists have suggested that feminism provides a number of benefits for women, particularly regarding self-evaluations. However, most studies have conflated feminist attitudes and feminist identity. The main goal of this study was to assess the differential relationships of feminist attitudes and feminist identity to self-efficacy. Four…

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. II. Features of and lessons from the follow-up investigations].

PubMed

Jermendy, György

2018-04-01

Although the outcomes of the follow-up investigation period of the randomized clinical studies for evaluating the efficacy of a treatment or an antidiabetic drug may be confounded or potentially biased by several factors, the results are widely accepted by the diabetes community. In line with the theory of metabolic memory or metabolic legacy, early and intensive antihyperglycaemic treatment should be provided for all diabetic patients as this strategy can result in beneficial effects even in the long run. The recent cardiovascular safety trials with new, innovative antidiabetic drugs differ in several aspects from the former efficacy studies. Ten cardiovascular safety trials were completed so far enabling to define their unique and common features. It can be anticipated that the era of randomized, controlled efficacy studies with observational follow-up investigations came to an end in diabetes research. Nowadays, cardiovascular safety trials are in the focus of clinical research in diabetology and results of several ongoing studies are expected with interest in the near future. Orv Hetil. 2018; 159(16): 615-619.

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

PubMed

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

2017-09-01

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

The Predictive Power of the Self-Efficacy Beliefs of Physical Education Candidate Teachers on Their Attitudes towards the Assessment and Evaluation in Education

ERIC Educational Resources Information Center

Varol, Yaprak Kalemoglu

2016-01-01

The aim of the research is to examine relationship between self-efficacy beliefs and attitudes for assessment and evaluation of physical education candidate teachers. In this research, the relational model has been used. Study group consists of 86 women (48%), 93 men (52%) and total 179 physical education teacher candidates (M[subscript age] =…

Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem

PubMed Central

Roehrs, Timothy A.; Roth, Thomas

2016-01-01

Study Objectives: Studies have shown pharmacokinetic differences for hypnotics in women compared to men, but few studies have assessed either short-or long-term differences in efficacy and safety. Methods: To evaluate gender differences in the efficacy and safety of chronic nightly zolpidem (10 mg), we did a post hoc assessment of a large clinical trial. In the trial, participants with primary insomnia (n = 89), ages 23–70, meeting DSM-IV-TR criteria for primary insomnia were randomized, double blind, to nightly zolpidem, 10 mg (n = 47) or placebo (n = 42) 30 minutes before bedtime nightly for 12 months. Polysomnographic sleep on 2 nights in months 1 and 8 and likelihood of next-day sleepiness, rebound insomnia, and dose escalation were evaluated in months 1, 4, and 12. Results: Relative to placebo, zolpidem significantly increased sleep efficiency and reduced sleep latency and wake after sleep onset assessed at months 1 and 8, with no differences in efficacy between women and men and no diminution of efficacy over months. On a next-day multiple sleep latency test (MSLT), no residual sedation was observed for either women or men. No rebound insomnia or dose escalation was seen with no gender differences in either. Conclusions: In adults with primary insomnia, nightly zolpidem administration showed no gender differences in acute or chronic efficacy or in next-day sleepiness. Zolpidem remained efficacious and safe across 12 months. Clincial Trials Registration: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525. Citation: Roehrs TA, Roth T. Gender differences in the efficacy and safety of chronic nightly zolpidem. J Clin Sleep Med 2016;12(3):319–325. PMID:26446253

Development and evaluation of a self-efficacy instrument for Japanese sleep apnea patients receiving continuous positive airway pressure treatment

PubMed Central

Saito, Ayako; Kojima, Shigeko; Sasaki, Fumihiko; Hayashi, Masamichi; Mieno, Yuki; Sakakibara, Hiroki; Hashimoto, Shuji

2015-01-01

The purpose of this study was to develop and evaluate a self-efficacy instrument for Japanese obstructive sleep apnea (OSA) patients treated with continuous positive airway pressure (CPAP). Analyzed subjects were 653 Japanese OSA patients (619 males and 34 females) treated with CPAP at a sleep laboratory in a respiratory clinic in a Japanese city. Based on Bandura’s social cognitive theory, the CPAP Self-Efficacy Questionnaire for Sleep Apnea in Japanese (CSESA-J) was developed by a focus group of experts, using a group interview of OSA patients for the items of two previous self-efficacy scales for Western sleep apnea patients receiving CPAP treatment. CSESA-J has two subscales, one for self-efficacy and the other for outcome expectancy, and consists of a total of 15 items. Content validity was confirmed by the focus group. Confirmatory factor analysis showed that the factor loadings of self-efficacy and outcome expectancy were 0.47–0.76 and 0.41–0.92, respectively, for the corresponding items. CSESA-J had a significant but weak positive association with the General Self-Efficacy Scale, and a strong positive association with “Self-efficacy scale on health behavior in patients with chronic disease.” Cronbach’s alpha coefficient was 0.85 for the self-efficacy subscale and 0.89 for the outcome expectancy subscale. The intraclass correlation coefficient using data from the first and second measurements with CSESA-J for a subset of 130 subjects was 0.93 for the self-efficacy and outcome expectancy subscales. These results support CSESA-J as a reliable and valid instrument for measuring the self-efficacy of Japanese OSA patients treated with CPAP. Further studies are warranted to confirm validity for female OSA patients and generalizability. PMID:25678832

[Reasearch progress in health economic evaluation of colorectal cancer screening in China].

PubMed

Huang, Huiyao; Shi, Jufang; Dai, Min

2015-08-01

Burden of colorectal cancer is rising in China. More attention and financial input have been paid to it by central government that colorectal cancer screening program has been carried out recently in many areas in China. Diversity of screening strategies and limited health resources render selecting the best strategy in a population-wide program a challenging task that economy was also required to be considered except safety and efficacy. To provide a reference for the subsequent further economic evaluation, here we reviewed the evidence available on the economic evaluation of colorectal cancer screening in China. Meanwhile, information related to screening strategies, participation and mid-term efficacy of screening, information and results on economic evaluation were extracted and summarized. Three of the four studies finally included evaluated strategies combining immunochemical fecel occult blood test (iFOBT) with high-risk factor questionnaire as initial screening, colonoscopy as diagnostic screening. There was a consensus regarding the efficacy and effectiveness of screening compared to no screening. Whereas the lack and poor comparability between studies, multi-perspective and multi-phase economic evaluation of colorectal cancer screening is needed, relying on current population-based screening program to conduct a comprehensive cost accounting.

The Relationship of Gender and Self-Efficacy on Social Physique Anxiety among College Students.

PubMed

Rothberger, Sara M; Harris, Brandonn S; Czech, Daniel R; Melton, Bridget

The anxiety or fear associated with physique evaluation is defined as Social Physique Anxiety (SPA). Numerous studies have examined this construct, yet a gap exists exploring this phenomenon among current college students with SPA, self-efficacy, and gender concurrently. Therefore, the purposes of this study included quantitatively analyzing the association between SPA, gender, and self-efficacy. Participants included 237 students at a Southeastern university participating in jogging, body conditioning, or weight training courses. Analysis of Variance yielded a significant main effect for self-efficacy as well, as those with lower self-efficacy displayed higher levels of SPA ( p < 0.001). Stepwise regression analysis indicated self-efficacy and gender were both significant predictors of SPA. This information could aid in creating interventions designed to decrease the prevalence of SPA and increase levels of self-efficacy among the current college student population.

Self-Efficacy for Coping with Cancer Enhances the Effect of Reiki Treatments During the Pre-Surgery Phase of Breast Cancer Patients.

PubMed

Chirico, Andrea; D'Aiuto, Giuseppe; Penon, Antonella; Mallia, Luca; DE Laurentiis, Michelino; Lucidi, Fabio; Botti, Gerardo; Giordano, Antonio

2017-07-01

Self-efficacy for coping with cancer plays a critical role in influencing psychological cancer-related outcomes, some studies suggested its role in enhancing or reducing the effects of psychological interventions in cancer patients. Reiki has recently been included among the efficacious complementary therapeutic intervention for cancer patients. The present study evaluated the role of self-efficacy for coping with cancer as buffer of the Reiki treatment effects on cancer-related symptoms in a randomized controlled trial (intervention versus control group) of breast cancer patients (N=110) during the pre-surgery phase. Results showed that self-efficacy for coping with cancer can influence the effect of a Reiki treatment. Higher efficacious patients showed a more powerful effect of the Reiki intervention on both anxiety and mood than the low efficacious patients. From a practical perspective, the study provides insightful results for healthcare professionals. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

TREATMENT TRIAL AND LONG-TERM FOLLOW-UP EVALUATION AMONG COMORBID YOUTH WITH MAJOR DEPRESSION AND A CANNABIS USE DISORDER.

PubMed

Cornelius, Jack R; Salloum, Ihsan M; Ferrell, Robert; Douaihy, Antoine B; Hayes, Jeanie; Kirisci, Levent; Horner, Michelle; Daley, Dennis C

2012-01-01

This study compared the acute phase (12-week) and the long-term (1 year) efficacy of fluoxetine versus placebo for the treatment of the depressive symptoms and the cannabis use of youth with comorbid major depressive disorder (MDD) and an cannabis use disorder (CUD)(cannabis dependence or cannabis abuse). We hypothesized that fluoxetine would demonstrate efficacy in the acute phase trial and at the 1-year follow-up evaluation. Data is also provided regarding the prevalence of risky sexual behaviors in our study sample. We recently completed the first double-blind placebo-controlled study of fluoxetine in adolescents and young adults with comorbid MDD/CUD. A total of 70 persons participated in the acute phase trial, and 68 of those persons (97%) also participated in the 1-year follow-up evaluation. Results of the acute phase study have already been presented (Cornelius, Bukstein, et al., 2010), but the results of the 1 year follow-up assessment have not been published previously. All participants in both treatment groups also received manual-based cognitive behavioral therapy (CBT) and motivation enhancement therapy (MET) during the 12-week course of the study. The 1-year follow-up evaluation was conducted to assess whether the clinical improvements noted during the acute phase trial persisted long term. During the acute phase trial, subjects in both the fluoxetine group and the placebo group showed significant within-group improvement in depressive symptoms and in cannabis-related symptoms. However, no significant difference was noted between the floxetine group and the placebo group on any treatment outcome variable during the acute phase trial. End of study levels of depressive symptoms were low in both the fluoxetine group and the placebo group. Most of the clinical improvements in depressive symptoms and for cannabis-related symptoms persisted at the 1-year follow-up evaluation. Fluoxetine did not demonstrate greater efficacy than placebo for treating either the depressive symptoms or the cannabis-related symptoms of our study sample during the acute phase study or at the 1-year follow-up assessment. The lack of a significant treatment effect for fluoxetine may at least in part reflect efficacy of the CBT/MET psychotherapy. A persistence of the efficacy of the acute phase treatment was noted at the 1-year follow-up evaluation, suggesting long-term effectiveness for the CBT/MET psychotherapy.

Management of rosacea-prone skin: evaluation of a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay Thermal spring water as monotherapy or adjunctive therapy.

PubMed

Seite, Sophie; Benech, Florence; Berdah, Sandrine; Bayer, Muriel; Veyrat, Sophie; Segot, Evelyne; Sakalikova, Marcela; Gibejova, Lucia; Zelenkova, Hana

2013-08-01

The objective of these studies was to investigate whether a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay thermal spring water formulated in a highly protective packaging can have an impact in the management of rosacea-prone skin subjects. Several studies were performed to evaluate the efficacy of this product in the management of rosacea prone skin, as either monotherapy or adjunctive therapy or to maintain the efficacy of a Metronidazole treatment. The first study was performed on 37 women aged 18-45 with added stage 2 erythro-couperosis, who applied test formula as monotherapy twice a day for 4 weeks. During a second study, a dermatological evaluation was performed on patients with stage I or II rosacea, a questionnaire containing information about patient characteristics, tolerance, clinical signs, symptoms and skin reactivity to "trigger factors" was completed by dermatologists at baseline and 2 months after treatment with the test formula as either monotherapy or adjunctive therapy. Finally, in a third study, 65 patients finishing a Metronidazole treatment applied once daily and the tested formula twice daily were divided into 2 groups using the test formula or vehicle control, twice a day for 8 weeks for the evaluation of efficacy as adjunctive therapy. We noted that the test formula, as an adjunctive therapy, helped prolong the efficacy of a Metronidazole treatment. In monotherapy, there was a significant efficacy of the test formula associated with an excellent tolerance. A significant improvement of all the clinical signs and symptoms of rosacea and a reduction of the skin reactivity to "trigger factors" were shown. These studies highlight the interest value and impact of a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay thermal spring water formulated in a highly protective packaging in monotherapy or in combination with or after a therapeutic treatment in the management of patients suffering from rosacea.

Psychometric Properties of a Scale to Assess Parental Self-Efficacy for Influencing Children's Dietary, Physical Activity, Sedentary, and Screen Time Behaviors in Disadvantaged Areas

ERIC Educational Resources Information Center

Norman, Åsa; Bohman, Benjamin; Nyberg, Gisela; Schäfer Elinder, Liselotte

2018-01-01

Background: According to social cognitive theory, self-efficacy is central to behavior change. Consequently, parental self-efficacy (PSE) for influencing children's dietary, physical activity (PA), sedentary, and screen time behaviors is important for child obesity prevention. The aim of this study was to evaluate the psychometric properties of an…

Beliefs and Technology--Does One Lead to the Other? Evaluating the Effects of Teacher Self-Efficacy and School Collective Efficacy on Technology Use in the Classroom

ERIC Educational Resources Information Center

Studnicki, Elaine Ann

2012-01-01

This exploratory mixed method study builds upon previous research to investigate the influence of teacher self- and collective efficacy on technology use in the classroom. This population was purposefully sampled to examine first- and second order technology barriers, instructional strategies, and human influences on technology. The quantitative…

Seasonal influenza vaccine efficacy and its determinants in children and non-elderly adults: a systematic review with meta-analyses of controlled trials.

PubMed

DiazGranados, Carlos A; Denis, Martine; Plotkin, Stanley

2012-12-17

The true level of influenza vaccine efficacy is controversial and many factors may influence its estimation. To estimate the efficacy of vaccination of children and non-elderly adults for the prevention of influenza and to explore the impact of type of vaccine, age, degree of strain matching, influenza type and case ascertainment methods on vaccine efficacy estimates. Medline and EmBase databases until October 2011. References of relevant articles were also reviewed. Controlled trials evaluating seasonal influenza vaccines and presenting incidence of laboratory-confirmed influenza illness were eligible. Studies exploring efficacy after experimental challenge, presenting duplicate data, employing group randomization, or focusing on special populations were excluded. The vaccine effect on influenza prevention was evaluated by calculating Mantel-Haenszel risk ratios (RR) and using random-effects models. Vaccine efficacies were calculated for each comparison as (1-RR)×100. Thirty studies were included in one or more of a total of 101 analyses, comprising 88.468 study participants. There was evidence of heterogeneity in 49% of the analyses. Summary vaccine efficacy was 65% against any strain, 78% against matched strains and 55% against not-matched strains. Both live-attenuated and inactivated vaccines showed similar levels of protection against not-matched strains (60% and 55%, respectively). Live-attenuated vaccines performed better than inactivated vaccines in children (80% versus 48%), whereas inactivated vaccines performed better than live-attenuated vaccines in adults (59% versus 39%). There was a large difference (20%) in efficacy against influenza A (69%) and influenza B (49%) types for not-matched strains. Summary estimates of vaccine efficacy were highest when ascertainment was based on culture confirmation. Influenza vaccines are efficacious, but efficacy estimates depend on many variables including type of vaccine and age of vaccinees, degree of matching of the circulating strains to the vaccine, influenza type, and methods of case ascertainment. Copyright © 2012 Elsevier Ltd. All rights reserved.

Methods for Evaluating the Content, Usability, and Efficacy of Commercial Mobile Health Apps

PubMed Central

Silfee, Valerie J; Waring, Molly E; Boudreaux, Edwin D; Sadasivam, Rajani S; Mullen, Sean P; Carey, Jennifer L; Hayes, Rashelle B; Ding, Eric Y; Bennett, Gary G; Pagoto, Sherry L

2017-01-01

Commercial mobile apps for health behavior change are flourishing in the marketplace, but little evidence exists to support their use. This paper summarizes methods for evaluating the content, usability, and efficacy of commercially available health apps. Content analyses can be used to compare app features with clinical guidelines, evidence-based protocols, and behavior change techniques. Usability testing can establish how well an app functions and serves its intended purpose for a target population. Observational studies can explore the association between use and clinical and behavioral outcomes. Finally, efficacy testing can establish whether a commercial app impacts an outcome of interest via a variety of study designs, including randomized trials, multiphase optimization studies, and N-of-1 studies. Evidence in all these forms would increase adoption of commercial apps in clinical practice, inform the development of the next generation of apps, and ultimately increase the impact of commercial apps. PMID:29254914

Small Intestinal Submucosa Plug for Closure of Dilated Nephrostomy Tracts: A Pilot Study in Swine

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

Kakizawa, Hideyaki; Conlin, M. J.; Pavcnik, Dusan, E-mail: pavcnikd@ohsu.edu

2010-06-15

The aim of this study was to evaluate efficacy of a plug made of small intestinal submucosa (SIS) for closure of dilated nephrostomy tract in the kidney after nephroscopy. Ten kidneys in 5 swine had nephrostomy tracts dilated up to 8 mm. The SIS plug was placed into the dilated renal cortex under nephroscopic control. Follow-up arteriograms, retrograde pyelograms, and macroscopic and histologic studies at 24 h (n = 4), 6 weeks (n = 2), and 3 months (n = 4) were performed to evaluate the efficacy of the plug. The SIS plug effectively closed the dilated nephrostomy tract. Follow-upmore » studies showed minimal changes of the kidneys, except for 1 small infarction, regarding inflammatory and foreign-body reactions and progressive scarring of the SIS. SIS plug is effective for occlusion of dilated nephrostomy tract after nephroscopy. Its efficacy should be compared with other therapeutic options.« less

Do the unique properties of nanometals affect leachability or efficacy against fungi and termites? International biodeterioration & biodegradation

Treesearch

S. N. Kartal; Frederick Green; Carol A. Clausen

2009-01-01

Nanotechnology has the potential to affect the field of wood preservation through the creation of new and unique metal biocides with improved properties. This study evaluated leachability and efficacy of southern yellow pine wood...

Efficacy against nematode and cestode infections and safety of a novel topical fipronil, (S)-methoprene, eprinomectin and praziquantel combination product in domestic cats under field conditions in Europe.

PubMed

Rehbein, Steffen; Capári, Balazs; Duscher, Georg; Keidane, Dace; Kirkova, Zvezdelina; Petkevičius, Saulius; Rapti, Dhimiter; Wagner, Annegret; Wagner, Thomas; Chester, S Theodore; Rosentel, Joseph; Tielemans, Eric; Visser, Martin; Winter, Renate; Kley, Katrin; Knaus, Martin

2014-04-28

A novel topical combination product (BROADLINE(®), Merial) composed of fipronil, (S)-methoprene, eprinomectin and praziquantel was evaluated for safety and efficacy against nematode and cestode infections in domestic cats. The study comprised a multi-centre, positive control, blinded, field study, using a randomized block design based on order of presentation for allocation. In total 196 client-owned cats, confirmed as positive for naturally acquired infections of nematodes and/or cestodes by pre-treatment faecal examination, were studied in seven countries in Europe. Pre-treatment faecal examination revealed the presence of Toxocara, hookworm, Capillaria and/or spirurid nematode infections in 129, 73, 33 or 1 cat(s), respectively; infections with taeniid and Dipylidium cestodes were demonstrated in 39 and 17 cats, respectively. Cats were allocated randomly to one of two treatments in a ratio of 2, topical fipronil (8.3%, w/v), (S)-methoprene (10%, w/v), eprinomectin (0.4%, w/v) and praziquantel (8.3%, w/v) (BROADLINE(®), Merial; 130 cats); and 1, topical PROFENDER(®) Spot-On (Bayer; 66 cats) and treated once on Day 0. For evaluation of efficacy, two faecal samples were collected, one prior to treatment (Day -4 ± 4 days) and one at the end of the study (Day 14 ± 5 days). These were examined for fecal forms of nematode and cestode parasites. For evaluation of safety, cats were examined by a veterinarian before treatment and at the end of the study, and cat owners recorded the health status of their cats daily until the end of the study. For cats treated with Broadline(®), the efficacy was >99.9%, 100%, and 99.6% for Toxocara, hookworms, and Capillaria, respectively; and the efficacy was >99.9%, >99.9%, and 98.5%, respectively, for the cats treated with Profender(®) (p<0.001 for all nematodes and both treatments). Efficacy was 100% for both cestodes for both treatments (p<0.001). No treatment related adverse experiences were observed throughout the study. For both treatments, every cat that completed the study was given a safety score of 'excellent' for both local and systemic evaluations. The topical combination product of fipronil, (S)-methoprene, eprinomectin and praziquantel was shown to have an excellent safety profile and demonstrated high levels of efficacy when administered once as topical solution to cats infected with nematodes and cestodes under field conditions. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

Tolerance and Efficacy of Emamectin Benzoate and Ivermectin for the Treatment of Pseudocapillaria tomentosa in Laboratory Zebrafish (Danio rerio)

PubMed Central

Collymore, Chereen; Watral, Virginia; White, Julie R.; Colvin, Michael E.; Rasmussen, Skye; Tolwani, Ravi J.

2014-01-01

Abstract Tolerance of adult zebrafish and efficacy of emamectin benzoate and ivermectin in eliminating Pseudocapillaria tomentosa infection were evaluated. In the tolerance study, behavioral changes, fecundity, histopathology, and mortality were evaluated for in-feed administration of emamectin (0.05, 0.10, and 0.25 mg/kg) and ivermectin (0.05 and 0.10 mg/kg). All doses of emamectin were well tolerated. Ivermectin 0.05 mg/kg administration resulted in mild behavioral changes and a transient decrease in fecundity. Ivermectin 0.10 mg/kg administration resulted in severe behavioral changes and some mortality. In the efficacy study, emamectin (0.05 and 0.25 mg/kg) and ivermectin (0.05 mg/kg) were evaluated for their efficacy in eliminating P. tomentosa infection. Emamectin reduced parasite burden in infected zebrafish, and ivermectin eliminated intestinal nematode infections. Despite a small margin of safety, ivermectin 0.05 mg/kg was effective at eliminating P. tomentosa infection in adult zebrafish. Higher doses or a longer course of treatment may be needed for complete elimination of P. tomentosa infection using emamectin. In this study, we propose two possible treatments for intestinal nematode infections in zebrafish. PMID:25237985

Systematic Review on Acupuncture for Treatment of Dysphagia after Stroke

PubMed Central

Ye, Qiuping; Xie, Yu; Shi, Junheng; Ou, Aihua; Xu, Nenggui

2017-01-01

Objective To assess the therapeutic efficacy of acupuncture for dysphagia after stroke. Methods Seven electronic databases were searched from their inception until 31 September 2016. All randomized controlled trials (RCTs) incorporating acupuncture or acupuncture combined with other interventions for treatment of dysphagia after stroke were enrolled. Then they were extracted and assessed by two independent evaluators. Direct comparisons were conducted in RevMan 5.3.0 software. Results 6010 patients of 71 papers were included. The pooled analysis of efficacy rate of 58 studies indicated that acupuncture group was superior to the control group with moderate heterogeneity (RR = 1.17, 95% CI: 1.13 1.21, Z = 9.08, and P < 0.00001); meta-analysis of the studies using blind method showed that the efficacy rate of acupuncture group was 3.01 times that of control group with no heterogeneity (RR = 3.01, 95% CI: 1.95 4.65, Z = 4.97, and P < 0.00001). Only 13 studies mentioned the safety evaluation. Conclusion The result showed that the acupuncture group was better than control group in terms of efficacy rate of dysphagia after stroke. And the combining result of those researches using blind method was more strong in proof. Strict evaluation standard and high-quality RCT design are necessary for further exploration. PMID:28852414

The impact of early psychosocial intervention on self-efficacy of care recipient/carer dyads living with early stage dementia - A mixed methods study.

PubMed

Stockwell-Smith, G; Moyle, W; Kellett, U

2018-05-13

To evaluate the effect of a targeted community-based psychosocial intervention on self-efficacy outcomes for care recipient/carer dyads living with early-stage dementia. There is increasing interest in the role of self-efficacy and self-management structures in determining positive outcomes for people with dementia. The assumption is that care recipient/carer dyads who receive early support to identify and adjust to dementia related changes will cope better in the long-term. An explanatory sequential mixed-method design was employed. Primarily quantitative with qualitative data providing a supportive secondary role to expand on and illuminate the quantitative findings. 88 dyads were recruited and allocated on a regional basis to an intervention or control group. Intervention group dyads received the Early Diagnosis Dyadic Intervention. Control group dyads received two information manuals. Quantitative data were collected at three time-points. Qualitative data were collected via evaluation questionnaires and semi-structured interviews. Intervention structure, content and delivery were acceptable to the dyads but few quantitative self-efficacy findings reached statistical significance. Improvements in self-efficacy were evident in the post-intervention evaluation qualitative responses where dyads expressed greater confidence in identifying and accessing community support. There is an urgent need for effective psychosocial interventions to help reduce the impact of dementia symptoms on patients, carers and society. This study makes an important contribution to our understanding of the capacity of psychosocial interventions to improve self-efficacy outcomes for care recipient/carer dyads with early-stage dementia while also illustrating the challenges associated with measuring self-efficacy in the early stages of the condition. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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.

Potential role of anticonvulsants in the treatment of obsessive-compulsive and related disorders.

PubMed

Wang, Hee Ryung; Woo, Young Sup; Bahk, Won-Myong

2014-10-01

We reviewed the extant literature to evaluate the current evidence regarding the efficacy and safety of anticonvulsants in the treatment of obsessive-compulsive and related disorders. Relevant literature was accessed using the Cochrane database, embase and PubMed on 29 October 2013. Prospective studies examining the efficacy of anticonvulsants in obsessive-compulsive and related disorders were included. Case reports, case series, and retrospective studies were excluded. A total of 10 studies were included in this review. The studies of obsessive-compulsive disorder, except for two negative studies, showed favorable efficacy results of anticonvulsants. In one study on body dysmorphic disorder, levetiracetam showed favorable efficacy. In two lamotrigine studies for pathologic skin-picking, the efficacy findings were inconsistent. In one trichotillomania study, topiramate had reduced hair-pulling symptoms. Despite limited evidence, our review suggests that anticonvulsants have a potential role in the treatment of obsessive-compulsive and related disorders. © 2014 The Authors. Psychiatry and Clinical Neurosciences © 2014 Japanese Society of Psychiatry and Neurology.

Pathogen-Specific T Cell Polyfunctionality Is a Correlate of T Cell Efficacy and Immune Protection

PubMed Central

Boyd, Anders; Almeida, Jorge R.; Darrah, Patricia A.; Sauce, Delphine; Seder, Robert A.; Appay, Victor; Gorochov, Guy; Larsen, Martin

2015-01-01

Introduction Understanding the factors that delineate the efficacy of T cell responses towards pathogens is crucial for our ability to develop potent therapies against infectious diseases. Multidimensional evaluation of T cell functionality at the single-cell level enables exhaustive analysis of combinatorial functional properties, hence polyfunctionality. We have recently invented an algorithm that quantifies polyfunctionality, the Polyfunctionality Index (Larsen et al. PLoS One 2012). Here we demonstrate that quantitative assessment of T cell polyfunctionality correlates with T cell efficacy measured as the capacity to kill target cells in vitro and control infection in vivo. Methods We employed the polyfunctionality index on two datasets selected for their unique ability to evaluate the polyfunctional imprint on T cell efficacy. 1) HIV-specific CD8+ T cells and 2) Leishmania major-specific CD4+ T cells were analysed for their capacity to secrete multiple effector molecules, kill target cells and control infection. Briefly, employing the Polyfunctionality Index algorithm we determined the parameter estimates resulting in optimal correlation between T cell polyfunctionality and T cell efficacy. Results T cell polyfunctionality is correlated with T cell efficacy measured as 1) target killing (r=0.807, P<0.0001) and 2) lesion size upon challenge with Leishmania major (r=-0.50, P=0.004). Contrary to an approach relying on the Polyfunctionality Index algorithm, quantitative evaluation of T cell polyfunctionality traditionally ignores the gradual contribution of more or less polyfunctional T cells. Indeed, comparing both approaches we show that optimal description of T cell efficacy is obtained when gradually integrating all levels of polyfunctionality in accordance with the Polyfunctionality Index. Conclusions Our study presents a generalizable methodology to objectively evaluate the impact of polyfunctionality on T cell efficacy. We show that T cell polyfunctionality is a superior correlate of T cell efficacy both in vitro and in vivo as compared with response size. Therefore, future immunotherapies should aim to increase T cell polyfunctionality. PMID:26046523

The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies.

PubMed

Ritter, Philip L; Lorig, Kate

2014-11-01

Self-efficacy theory, as developed by Bandura, suggests that self-efficacy is an important predictor of future behavior. The Chronic Disease Self-Management Program was designed to enhance self-efficacy as one approach to improving health behaviors and outcomes for people with varying chronic diseases. The six-item Self-Efficacy to Manage Chronic Disease Scale (SEMCD) and the four-item Spanish-language version (SEMCD-S) were developed to measure changes in self-efficacy in program participants and have been used in a numerous evaluations of chronic disease self-management programs. This study describes the development of the scales and their psychometric properties. Secondary analyses of questionnaire data from 2,866 participants in six studies are used to quantify and evaluate the SEMCD. Data from 868 participants in two studies are used for the SEMCD-S. Subjects consisted of individuals with various chronic conditions, who enrolled in chronic disease self-management programs (either small group or Internet based). Subjects came from United States, England, Canada, Mexico, and Australia. Descriptive statistics are summarized, reliability tested (Cronbach alpha), and principal component analyses applied to items. Baseline and change scores are correlated with baseline and change scores for five medical outcome variables that have been shown to be associated with self-efficacy measures in past studies. Principal component analyses confirmed the one-dimensional structure of the scales. The SEMCD had means ranging from 4.9 to 6.1 and the SEMCD-S 6.1 and 6.2. Internal consistency was high (Cronbach alpha, 0.88-0.95). The scales were sensitive to change and significantly correlated with health outcomes. The SEMCD and SEMCD-S are reliable and appear to be valid instruments for assessing self-efficacy for managing chronic disease. There was remarkable consistency across a range of studies from varying countries using two languages. Copyright © 2014 Elsevier Inc. All rights reserved.

Programs for the Prevention of Youth Depression: Evaluation of Efficacy, Effectiveness, and Readiness for Dissemination

PubMed Central

Brunwasser, Steven M.; Garber, Judy

2015-01-01

Objective To evaluate the current state of evidence of the effectiveness of depression prevention programs for youth, assess the degree to which current evidence supports broad implementation, and outline additional steps needed to close the gap between effectiveness and dissemination. Method We used the Society for Prevention Research’s Standards of Evidence (Flay et al., 2005) to evaluate the degree to which existing depression prevention programs have established intervention efficacy, effectiveness, and readiness for dissemination. We reviewed all depression prevention programs for youth that have been evaluated in at least two published, randomized controlled trials in which the intervention was compared to a no-intervention control group. A total of 37 studies evaluating 11 different programs were reviewed with regard to depressive symptoms and diagnoses post intervention and at follow-up (at least 6 months). Results Eight programs demonstrated significant main effects on depressive symptoms relative to controls in multiple RCTs; five programs had at least one trial with significant main effects present at least one year post-intervention. Two programs demonstrated efficacy for both depressive symptoms and depressive episodes across multiple independent trials. Regarding effectiveness, six programs had at least one study showing significant effects when delivered by endogenous service providers; four programs had significant effects in studies conducted independently of the program developers. Conclusions Several programs have demonstrated promise in terms of efficacy, but no depression prevention program for children or adolescents as yet has garnered sufficient evidence of effectiveness under real-world conditions to warrant widespread dissemination at this time. PMID:25933173

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.

Efficacy of an imidacloprid/flumethrin collar against fleas, ticks, mites and lice on dogs

PubMed Central

2012-01-01

Background The studies reported here were conducted to ascertain the efficacy of imidacloprid/flumethrin incorporated in a slow-release matrix collar, against infestations of dogs by fleas, ticks, mites and lice. Efficacy was evaluated against the flea Ctenocephalides felis felis, the ticks Rhipicephalus sanguineus, Ixodes ricinus, Ixodes scapularis, Dermacentor reticulatus and Dermacentor variabilis, the mite Sarcoptes scabiei and the biting louse Trichodectes canis. Methods Groups of collar-treated dogs (n = 7–10) were infested with fleas and/or ticks at monthly intervals at least, over a period of up to 8 months. Efficacy against fleas was evaluated 24 to 48 h after treatment and 24 h after each re-infestation. Efficacy against ticks was evaluated at 48 h (acaricidal), 6 h (repellent) and 48 h (sustained) after infestation. The effect of regular shampooing or immersion in water on the efficacy of the collars was also tested. Efficacy against flea larvae was assessed by incubating blanket samples after dog contact with viable flea eggs. Effectiveness against lice and mites was evaluated after treatment of naturally infested animals. With the exception of the mites, efficacy was calculated by comparison with untreated negative control groups. Results Efficacy against fleas (24 h) generally exceeded 95%, and against flea larvae it exceeded 99% for 8 months. Sustained acaricidal (48 h) efficacy, covering a period of 8 months was 100% against I. ricinus, starting 2 days after treatment (in vivo), and 100% against I. scapularis (in vitro), above 97% against R. sanguineus, generally above 97% against D. reticulatus and above 90% for D. variabilis. Repellent (6 h) efficacy 2 days after treatment and continuing for 8 months was consistently 100% against I. ricinus, and above 90% against R. sanguineus. Regular shampooing affected efficacy against fleas and ticks to a lesser extent than regular immersion in water. The collars eliminated Trichodectes canis within 2 days and Sarcoptes scabiei within 3 months. Conclusion The rapid insecticidal and acaricidal properties of the medicated collars against newly-acquired infestations of fleas and ticks and their sustained high levels of preventive efficacy have been clearly shown. Consequently they have the potential to prevent the transmission of vector-borne diseases and other conditions directly associated with infestation throughout an entire season of parasite abundance. PMID:22647530

Evaluation of the efficacy of DDT indoor residual spraying and long-lasting insecticidal nets against insecticide resistant populations of Anopheles arabiensis Patton (Diptera: Culicidae) from Ethiopia using experimental huts

PubMed Central

2014-01-01

Background Indoor Residual Spraying (IRS) and Long-Lasting Insecticidal nets (LLINs) are major malaria vector control tools in Ethiopia. However, recent reports from different parts of the country showed that populations of Anopheles arabiensis, the principal malaria vector, have developed resistance to most families of insecticides recommended for public health use which may compromise the efficacy of both of these key vector control interventions. Thus, this study evaluated the efficacy of DDT IRS and LLINs against resistant populations of An. arabiensis using experimental huts in Asendabo area, southwestern Ethiopia. Methods The susceptibility status of populations of An. arabiensis was assessed using WHO test kits to DDT, deltamethrin, malathion, lambda-cyhalothrin, fenitrothion and bendiocarb. The efficacy of LLIN (PermaNet® 2.0), was evaluated using the WHO cone bioassay. Moreover, the effect of the observed resistance against malaria vector control interventions (DDT IRS and LLINs) were assessed using experimental huts. Results The findings of this study revealed that populations of An. arabiensis were resistant to DDT, deltamethrin, lambda-cyhalothrin and malathion with mortality rates of 1.3%, 18.8%, 36.3% and 72.5%, respectively but susceptible to fenitrothion and bendiocarb with mortality rates of 98.81% and 97.5%, respectively. The bio-efficacy test of LLIN (PermaNet® 2.0) against An. arabiensis revealed that the mosquito population showed moderate knockdown (64%) and mortality (78%). Moreover, mosquito mortalities in DDT sprayed huts and in huts with LLINs were not significantly different (p > 0.05) from their respective controls. Conclusion The evaluation of the efficacy of DDT IRS and LLINs using experimental huts showed that both vector control tools had only low to moderate efficacy against An. arabiensis populations from Ethiopia. Despite DDT being replaced by carbamates for IRS, the low efficacy of LLINs against the resistant population of An. arabiensis is still a problem. Thus, there is a need for alternative vector control tools and implementation of appropriate insecticide resistance management strategies as part of integrated vector management by the national malaria control program. PMID:24678605

A Validity and Reliability Study of the Basic Electronics Skills Self-Efficacy Scale (BESS)

ERIC Educational Resources Information Center

Korkmaz, Ö.; Korkmaz, M. K.

2016-01-01

The aim of this study is to improve a measurement tool to evaluate the self-efficacy of Electrical-Electronics Engineering students through their basic electronics skills. The sample group is composed of 124 Electrical-Electronics engineering students. The validity of the scale is analyzed with two different methods through factor analysis and…

Efficacy, Outcomes, and Empowerment Evaluation of a School District NET Project. Research Brief.

ERIC Educational Resources Information Center

Miller-Whitehead, Marie

This study addressed the efficacy and outcomes of a U.S. Department of Agriculture Nutrition Education Training (NET) project designed to increase awareness of health risk and wellness factors for grade 9 high school students. The study also considered the empowerment fostered by the program and measured changes in the health and nutrition…

A Study of the Efficacy of Computerized Skill Building for Adolescents: Reducing Aggression and Increasing Pro-Social Behavior.

ERIC Educational Resources Information Center

Stern, Robin; Repa, J. Theodore

This article describes a pilot study that evaluated the efficacy of a computer-based, behavioral skill-building program in reducing aggression and improving academic performance among middle school students. The program is Ripple Effects'"Relate for Teens," a media rich, interactive application based on combining a proprietary learning…

21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) The National Academy of Sciences—National Research Council, Drug Efficacy Study Group, has completed... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... used, is a failure to disclose facts that are material in light of the representations made and causes...

21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) The National Academy of Sciences—National Research Council, Drug Efficacy Study Group, has completed... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... used, is a failure to disclose facts that are material in light of the representations made and causes...

21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) The National Academy of Sciences—National Research Council, Drug Efficacy Study Group, has completed... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... used, is a failure to disclose facts that are material in light of the representations made and causes...

21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) The National Academy of Sciences—National Research Council, Drug Efficacy Study Group, has completed... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... used, is a failure to disclose facts that are material in light of the representations made and causes...

Can a Self-Efficacy-Based Intervention Decrease Burnout, Increase Engagement, and Enhance Performance? A Quasi-Experimental Study

ERIC Educational Resources Information Center

Breso, Edgar; Schaufeli, Wilmar; Salanova, Marisa

2011-01-01

Using the Social Cognitive Theory as a theoretical framework, this study evaluated a 4-month, individual cognitive-behavioral intervention program to decrease burnout and increase self-efficacy, engagement, and performance among university students. The main objective of the intervention was to decrease the anxiety the students coped with before…

Does Digital Game Interactivity Always Promote Self-Efficacy?

PubMed

Lee, Yu-Hao

2015-11-01

Interactive digital games can promote self-efficacy by engaging players in enactive and observational learning. However, interactivity does not always lead to greater self-efficacy. Important constructs in social cognitive theory, such as performance outcome and perceived similarity, are often not accounted for in studies that have tested the effect of digital game interactivity on self-efficacy. This study assessed the effects of interactive digital games compared with passive digital games based on video comparison, a common experimental design used to test the effect of digital game interactivity on self-efficacy. In addition, this study also evaluated player performance and measured perceived similarity to the observed player. Findings suggested that in general, digital game interactivity predicted higher self-efficacy compared with noninteractive passive games. However, in the noninteractive conditions, the effects of performance on self-efficacy were moderated by perceived similarity between the observer and the observed player. When the observed player was perceived to be similar to the observer, the effects of performance on self-efficacy were comparable to the interactive game, but when the observed player was perceived as dissimilar to the observer, observing the dissimilar player failed to increase observer self-efficacy. Implications for interactivity manipulations and game developers are discussed.

[Efficacy and tolerability of 5% minoxidil solution (Carexidil®) in male and female androgenetic alopecia: a 6-month open multicentric study].

PubMed

Piraccini, B; Starace, M; Alessandrini, A; Guarrera, M; Fiorucci, M C; Lorenzi, S

2011-12-01

The aim of the study was to evaluate efficacy and safety of 5% Carexidil solution®, applied twice a day on the scalp, on male and female androgenetic alopecia. The 6 month-study was performed in three Italian dermatological centers. Evaluation of efficacy was performed with subjective and objective methods, including operator and patient assessments, global photography and videodermoscopy. Global photography revealed that after 6 months of treatment with 5% Carexidil solution®, androgenetic alopecia was improved in all 32 females and 16 males. Alopecia stopped to progress in 6 males. Scalp videodermoscopy confirmed the results. Some patients complained of increased hair greasiness, others complained of mild scalp itching. Two female patients developed contact sensitization to minoxidil, confirmed by patch test, 2 a mild malar-temporal hypertrichosis. All patients were satisfied by treatment and continued it after the end of the study. Our study confirms the data of the literature and the evidence coming from years of clinical experience, that twice a day topical application of 5% minoxidil solution, Carexidil ®, is effective in the treatment of male and female androgenetic alopecia, with evident efficacy already after 6 months.

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

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.

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.

Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-'Tabac Info Service': ee-TIS trial.

PubMed

Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F

2017-02-24

A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. NCT02841683; Pre-results. 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/.

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.

Research development of a new GnRH antagonist (Elagolix) for the treatment of endometriosis: a review of the literature.

PubMed

Alessandro, Pontis; Luigi, Nappi; Felice, Sorrentino; Maria, Paoletti Anna; Benedetto, Melis Gian; Stefano, Angioni

2017-04-01

Limitated studies have reported the efficacy of GnRH antagonist on endometriosis symptoms. The aim of our study was to review all available trials to investigate the medical treatment of endometriosis with only GnRH antagonists, with special attention to pharmacodynamic activity, safety, and efficacy. Pub Med and Sciencedirect database were searched using terms of "endometriosis treatment", "GnRH antagonist", and "Elagolix". The search was limited to clinical studies published in English. Title and abstract were screened to identify relevant articles. Five studies covering use of GnRH antagonist were found. A phase 1 study evaluated the safety, pharmacokinetics, and inhibitory effects on gonadotropins and estradiol of single dose and 7 day elagolix administration to healthy premenopausal women; two phase II studies evaluated efficacy in patient with endometriosis. Moreover, there are two Phase III clinical trials just completed. GnRH antagonists may have the advantage of oral administration and lower incidence of adverse events. Currently, only Phase II studies have been published demonstrating promising results in terms of efficacy, safety, and tolerability. From the results of the phase III studies, elagolix may become a valuable addition to the armamentarium of pharmacological agents to treat endometriosis-related pain.

Treating primary insomnia - the efficacy of valerian and hops.

PubMed

Salter, Shanah; Brownie, Sonya

2010-06-01

To evaluate the efficacy of valerian and hops in the treatment of primary insomnia. The AMED and MEDLINE databases were searched for primary sources of literature published between 1950 and 2009, using keywords: herbal medicine, medicinal plants, herbal, Valeriana officinalis, valerian, Humulus lupulus, hops, sleep, insomnia. Studies were included if they evaluated the efficacy of valerian or hops in improving primary insomnia in adults: sixteen studies met the inclusion criteria. Twelve of these found that the use of valerian, on its own, or in combination with hops, is associated with improvements in some sleep parameters (eg. sleep latency and quality of sleep). However, these results need to be interpreted cautiously as there were significant differences in design between the studies. Further randomised, double blind, placebo controlled trials are needed before such herbal treatments can be confidently recommended for the treatment of primary insomnia.

Evaluation of maternal attachment, self-efficacy, levels of depression, and anxiety in mothers who have babies diagnosed with retinopathy of prematurity.

PubMed

Özyurt, Gonca; Özyurt, Ayhan; Ozturk, Taylan; Yaman, Aylin; Berk, A Tulin

2018-04-01

The aim of this study is to evaluate the emotional stress and its effects on parental self-efficacy and mother-infant attachment in mothers whose babies were diagnosed with retinopathy of prematurity (ROP). Study sample was consisted of voluntarily participating 82 mothers whose babies were first diagnosed with ROP, 83 mothers of preterm babies without ROP, and 85 mothers of term babies admitting for their routine visits. Sociodemographic data form maternal attachment scale, state-trait anxiety inventory, Edinburgh postnatal depression scale, and parental self-efficacy scale were applied to study participants, and the overall results of three groups were statistically compared. The sociodemographic features of three study groups were similar. Statistical significant differences were found in depression and state anxiety levels among study groups, while maternal attachment scale and trait anxiety level scores and parental self-efficacy scale total score were similar in study groups. Maternal depression and state-anxiety levels were tend to be higher in mother of children diagnosed with ROP and prematurity; however, there were no statistically significant differences between levels of mothers' of premature children with or without ROP. This is the first study in literature assessing the additional effect of ROP on the anxiety and depression levels of recent mothers, as well as mother-infant attachment and parental self-efficacy. Supporting of mothers having an infant with diagnosed ROP is crucial because of feeling themselves inefficient and responsible for all interventions applied to their babies.

Optimization, characterization, and efficacy evaluation of 2% chitosan scaffold for tissue engineering and wound healing

PubMed Central

Chhabra, Priyanka; Tyagi, Priyanka; Bhatnagar, Aseem; Mittal, Gaurav; Kumar, Amit

2016-01-01

Objective: To develop a chitosan-based scaffold and carry out a complete comprehensive study encompassing optimization of exact chitosan strength, product characterization, toxicity evaluation, in vitro validation in cell culture experiments, and finally in vivo efficacy in animal excision wound model. Materials and Methods: Developed chitosan scaffolds (CSs) were optimized for tissue engineering and wound healing efficacy by means of microstructure, toxicity, and biocompatibility evaluation. Results: Scanning electron microscope (SEM) studies revealed that porosity of CS decreased with increase in chitosan concentration. Chemical stability and integrity of scaffolds were confirmed by Fourier transform infrared studies. Highest swelling percentage (SP) of 500% was observed in 2%, while lowest (200%) was observed in 1% CS. Reabsorption and noncytotoxic property of optimized scaffold were established by enzymatic degradation and MTT assay. Enzymatic degradation suggested 20–45% of weight loss (WL) within 14 days of incubation. Cytotoxicity analysis showed that scaffolds were noncytotoxic against normal human dermal fibroblast human dermal fibroblast cell lines. Significant cellular adherence over the scaffold surface with normal cellular morphology was confirmed using SEM analysis. In vivo efficacy evaluation was carried out by means of reduction in wound size on Sprague-Dawley rats. Sprague-Dawley rats treated with optimized scaffold showed ~ 100% wound healing in comparison to ~80% healing in betadine-treated animals within 14 days. Histological examination depicted advance re-epithelization with better organization of collagen bundle in wound area treated with 2% CS in comparison to conventional treatment or no treatment. Conclusion: This study, thus, reveals that 2% CSs were found to have a great potential in wound healing. PMID:28216954

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

Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa

PubMed Central

2011-01-01

Background GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative are working in partnership to develop a malaria vaccine to protect infants and children living in malaria endemic regions of sub-Saharan Africa, which can be delivered through the Expanded Programme on Immunization. The RTS,S/AS candidate vaccine has been evaluated in multiple phase I/II studies and shown to have a favourable safety profile and to be well-tolerated in both adults and children. This paper details the design of the phase III multicentre efficacy trial of the RTS,S/AS01 malaria vaccine candidate, which is pivotal for licensure and policy decision-making. Methods The phase III trial is a randomized, controlled, multicentre, participant- and observer-blind study on-going in 11 centres associated with different malaria transmission settings in seven countries in sub-Saharan Africa. A minimum of 6,000 children in each of two age categories (6-12 weeks, 5-17 months) have been enrolled. Children were randomized 1:1:1 to one of three study groups: (1) primary vaccination with RTS,S/AS01 and booster dose of RTS,S/AS01; (2) primary vaccination with RTS,S/AS01 and a control vaccine at time of booster; (3) primary vaccination with control vaccine and a control vaccine at time of booster. Primary vaccination comprises three doses at monthly intervals; the booster dose is administered at 18 months post-primary course. Subjects will be followed to study month 32. The co-primary objectives are the evaluation of efficacy over one year post-dose 3 against clinical malaria when primary immunization is delivered at: (1) 6-12 weeks of age, with co-administration of DTPwHepB/Hib antigens and OPV; (2) 5-17 months of age. Secondary objectives include evaluation of vaccine efficacy against severe malaria, anaemia, malaria hospitalization, fatal malaria, all-cause mortality and other serious illnesses including sepsis and pneumonia. Efficacy of the vaccine against clinical malaria under different transmission settings, the evolution of efficacy over time and the potential benefit of a booster will be evaluated. In addition, the effect of RTS,S/AS01 vaccination on growth, and the safety and immunogenicity in HIV-infected and malnourished children will be assessed. Safety of the primary course of immunization and the booster dose will be documented in both age categories. Conclusions This pivotal phase III study of the RTS,S/AS01 candidate malaria vaccine in African children was designed and implemented by the Clinical Trials Partnership Committee. The study will provide efficacy and safety data to fulfil regulatory requirements, together with data on a broad range of endpoints that will facilitate the evaluation of the public health impact of the vaccine and will aid policy and implementation decisions. Trial registration Clinicaltrials.gov NCT00866619 PMID:21816029

World Association for the Advancement of Veterinary Parasitology (WAAVP): Guideline for the evaluation of drug efficacy against non-coccidial gastrointestinal protozoa in livestock and companion animals.

PubMed

Geurden, T; Olson, M E; O'Handley, R M; Schetters, T; Bowman, D; Vercruysse, J

2014-08-29

The current guideline was written to aid in the design, implementation and interpretation of studies for the assessment of drug efficacy against non-coccidial gastrointestinal protozoan parasites, with Giardia spp. as the leading example. The information provided in this guideline deals with aspects of how to conduct controlled studies using experimental infection models (dose determination and dose confirmation) and efficacy studies in commercial facilities (field effectiveness studies). Furthermore, the selection of suitable animals, housing, infection procedure, choice of diagnostic technique and data analysis are discussed. This guideline is intended to assist investigators in conducting specific studies, to provide specific information for registration authorities involved in the decision-making process, to assist in the approval and registration of new drugs and to facilitate the worldwide adoption of uniform procedures. The primary parameter for drug efficacy is the reduction in either parasite excretion or parasite counts and a minimum efficacy of 90% is required against non-coccidial gastrointestinal protozoa. A supporting efficacy parameter is a significant difference in the proportion of infected animals between treated and non-treated groups. Persistent efficacy is considered as an additional claim to therapeutic efficacy. Copyright © 2014 Elsevier B.V. All rights reserved.

Traditional and Accelerated Baccalaureate Nursing Students' Self-Efficacy for Interprofessional Learning.

PubMed

Durkin, Anne E; Feinn, Richard S

The aim of the study was to examine self-efficacy among traditional and accelerated nursing students with regard to interprofessional learning. The World Health Organization and other organizations recognize the need for interprofessional education to prepare health care providers for collaborative practice. Graduates of baccalaureate nursing programs require competence in interprofessional collaboration and communication. Traditional (n = 239) and accelerated (n = 114) nursing students' self-efficacy was measured utilizing Mann et al.'s Self-Efficacy for Interprofessional Experiential Learning Scale. Accelerated students averaged significantly higher than traditional students on the interprofessional team evaluation and feedback subscale (p = .006) and overall self-efficacy (p = .041). Awareness of possible differences between traditional and accelerated nursing students with regard to self-efficacy may help faculty develop effective interprofessional learning experiences for students in each cohort. Although results cannot be generalized, findings from this study provide evidence to guide the selection of learning strategies.

[Validity and reliability of a scale to assess self-efficacy for physical activity in elderly].

PubMed

Borges, Rossana Arruda; Rech, Cassiano Ricardo; Meurer, Simone Teresinha; Benedetti, Tânia Rosane Bertoldo

2015-04-01

This study aimed to analyze the confirmatory factor validity and reliability of a self-efficacy scale for physical activity in a sample of 118 elderly (78% women) from 60 to 90 years of age. Mplus 6.1 was used to evaluate the confirmatory factor analysis. Reliability was tested by internal consistency and temporal stability. The original scale consisted of five items with dichotomous answers (yes/no), independently for walking and moderate and vigorous physical activity. The analysis excluded the item related to confidence in performing physical activities when on vacation. Two constructs were identified, called "self-efficacy for walking" and "self-efficacy for moderate and vigorous physical activity", with a factor load ≥ 0.50. Internal consistency was adequate both for walking (> 0.70) and moderate and vigorous physical activity (> 0.80), and temporal stability was adequate for all the items. In conclusion, the self-efficacy scale for physical activity showed adequate validity, reliability, and internal consistency for evaluating this construct in elderly Brazilians.

Impact of in-home behavioral management versus telephone support to reduce depressive symptoms and perceived stress in Chinese caregivers: results of a pilot study.

PubMed

Gallagher-Thompson, Dolores; Gray, Heather L; Tang, Paulette C Y; Pu, Chun Yu; Leung, Laurie Y L; Wang, Peng-Chih; Tse, Collins; Hsu, Shannon; Kwo, Elizabeth; Tong, Hui-Qi; Long, James; Thompson, Larry W

2007-05-01

Recent work has shown that Chinese Americans caring for a family member with dementia experience considerable psychological distress. However, few studies evaluate treatments for them. This study evaluated the efficacy of in-home intervention, based on cognitive behavior therapy principles, to relieve stress and depression in female Chinese American caregivers (CGs). Fifty-five CGs who met inclusion criteria were randomly assigned to a telephone support condition (TSC) or to an in-home behavioral management program (IHBMP) for 4 months. In the TSC, biweekly calls were made and relevant material was mailed. In the IHBMP, specific psychological skills were taught to deal with caregiving stress. CGs were assessed before and after treatment. Outcome measures evaluated overall perceived stress, caregiving-specific stress, and depressive symptoms. CGs in IHBMP were less bothered by caregiving-specific stressors and had lower depression levels than CGs in TSC. There was no difference in overall stress. CGs with low baseline level of self-efficacy for obtaining respite benefited from IHBMP, but showed little improvement in the TSC. CGs with higher self-efficacy benefited from both treatments. This intervention is promising and warrants replication in future studies. Additional research is needed to evaluate longer-term effects and to identify individual differences associated with improvement.

Enhancing Learning Outcomes through Evaluation of Serious Gaming: A Mixed Methods Study

ERIC Educational Resources Information Center

Douglas, Kerrie Anna

2012-01-01

This study compared the change in counseling student's self-efficacy and skill related to suicide assessment and intervention through the use of a novel intervention-oriented evaluation method, evaluation focused discussion groups, in an experimental embedded mixed methods design. An innovation counselor pedagogical tool, Suicide Risk Assessment…

Evaluation of standardized sample collection, packaging, and decontamination procedures to assess cross-contamination potential during Bacillus anthracis incident response operations

PubMed Central

Calfee, M. Worth; Tufts, Jenia; Meyer, Kathryn; McConkey, Katrina; Mickelsen, Leroy; Rose, Laura; Dowell, Chad; Delaney, Lisa; Weber, Angela; Morse, Stephen; Chaitram, Jasmine; Gray, Marshall

2016-01-01

Sample collection procedures and primary receptacle (sample container and bag) decontamination methods should prevent contaminant transfer between contaminated and non-contaminated surfaces and areas during bio-incident operations. Cross-contamination of personnel, equipment, or sample containers may result in the exfiltration of biological agent from the exclusion (hot) zone and have unintended negative consequences on response resources, activities and outcomes. The current study was designed to: (1) evaluate currently recommended sample collection and packaging procedures to identify procedural steps that may increase the likelihood of spore exfiltration or contaminant transfer; (2) evaluate the efficacy of currently recommended primary receptacle decontamination procedures; and (3) evaluate the efficacy of outer packaging decontamination methods. Wet- and dry-deposited fluorescent tracer powder was used in contaminant transfer tests to qualitatively evaluate the currently-recommended sample collection procedures. Bacillus atrophaeus spores, a surrogate for Bacillus anthracis, were used to evaluate the efficacy of spray- and wipe-based decontamination procedures. Both decontamination procedures were quantitatively evaluated on three types of sample packaging materials (corrugated fiberboard, polystyrene foam, and polyethylene plastic), and two contamination mechanisms (wet or dry inoculums). Contaminant transfer results suggested that size-appropriate gloves should be worn by personnel, templates should not be taped to or removed from surfaces, and primary receptacles should be selected carefully. The decontamination tests indicated that wipe-based decontamination procedures may be more effective than spray-based procedures; efficacy was not influenced by material type but was affected by the inoculation method. Incomplete surface decontamination was observed in all tests with dry inoculums. This study provides a foundation for optimizing current B. anthracis response procedures to minimize contaminant exfiltration. PMID:27362274

Evaluation of standardized sample collection, packaging, and decontamination procedures to assess cross-contamination potential during Bacillus anthracis incident response operations.

PubMed

Calfee, M Worth; Tufts, Jenia; Meyer, Kathryn; McConkey, Katrina; Mickelsen, Leroy; Rose, Laura; Dowell, Chad; Delaney, Lisa; Weber, Angela; Morse, Stephen; Chaitram, Jasmine; Gray, Marshall

2016-12-01

Sample collection procedures and primary receptacle (sample container and bag) decontamination methods should prevent contaminant transfer between contaminated and non-contaminated surfaces and areas during bio-incident operations. Cross-contamination of personnel, equipment, or sample containers may result in the exfiltration of biological agent from the exclusion (hot) zone and have unintended negative consequences on response resources, activities and outcomes. The current study was designed to: (1) evaluate currently recommended sample collection and packaging procedures to identify procedural steps that may increase the likelihood of spore exfiltration or contaminant transfer; (2) evaluate the efficacy of currently recommended primary receptacle decontamination procedures; and (3) evaluate the efficacy of outer packaging decontamination methods. Wet- and dry-deposited fluorescent tracer powder was used in contaminant transfer tests to qualitatively evaluate the currently-recommended sample collection procedures. Bacillus atrophaeus spores, a surrogate for Bacillus anthracis, were used to evaluate the efficacy of spray- and wipe-based decontamination procedures. Both decontamination procedures were quantitatively evaluated on three types of sample packaging materials (corrugated fiberboard, polystyrene foam, and polyethylene plastic), and two contamination mechanisms (wet or dry inoculums). Contaminant transfer results suggested that size-appropriate gloves should be worn by personnel, templates should not be taped to or removed from surfaces, and primary receptacles should be selected carefully. The decontamination tests indicated that wipe-based decontamination procedures may be more effective than spray-based procedures; efficacy was not influenced by material type but was affected by the inoculation method. Incomplete surface decontamination was observed in all tests with dry inoculums. This study provides a foundation for optimizing current B. anthracis response procedures to minimize contaminant exfiltration.

Modification to the AOAC Sporicidal Activity of Disinfectants Test (Method 966.04): collaborative study.

PubMed

Tomasino, Stephen F; Hamilton, Martin A

2006-01-01

In an effort to improve AOAC Method 966.04, the Sporicidal Activity of Disinfectants Test, selected modifications to the procedure were evaluated in a collaborative study. Method 966.04 is used to generate efficacy data to support the product registration of sporicides and sterilants. The method is a carrier-based test that provides a qualitative measure of product efficacy against spores of Bacillus subtilis and Clostridium sporogenes. The use of garden soil extract and the lack of standard procedures for the enumeration of spores and neutralization of the test chemicals have been considered problematic for many years. The proposed modifications were limited to the B. subtilis and hard surface carrier (porcelain penicylinder) components of the method. The study included the evaluation of a replacement for soil extract nutrient broth and an establishment of a minimum spore titer per carrier, both considered crucial for the improvement and utilization of the method. Additionally, an alternative hard surface material and a neutralization confirmation procedure were evaluated. To determine the equivalence of the proposed alternatives to the standard method, 3 medium/carrier combinations, (1) soil extract nutrient broth/porcelain carrier (current method), (2) nutrient agar amended with 5 microg/mL manganese sulfate/porcelain carrier, and (3) nutrient agar amended with 5 microg/mL manganese sulfate/stainless steel carrier were analyzed for carrier counts, HCI resistance, efficacy, quantitative efficacy, and spore wash-off. The test chemicals used in the study represent 3 chemical classes and are commercially available antimicrobial liquid products: sodium hypochlorite (bleach), glutaraldehyde, and a combination of peracetic acid and hydrogen peroxide. Four laboratories participated in the study. The results of the spore titer per carrier, HCI resistance, efficacy, and wash-off studies demonstrate that amended nutrient agar in conjunction with the porcelain is comparable to the current method, soil extract nutrient broth/porcelain. The nutrient agar method is simple, inexpensive, reproducible, and provides an ample supply of high quality spores. Due to the current use of porcelain carriers for testing C. sporogenes, it is advisable to retain the use of porcelain carriers until stainless steel can be evaluated as a replacement carrier material for Clostridium. The evaluation of stainless steel for Clostridium has been initiated by the Study Director. Study Director recommendations for First Action revisions are provided in a modified method.

Contralaterally Controlled Functional Electrical Stimulation for Stroke Rehabilitation

PubMed Central

Knutson, Jayme S.; Harley, Mary Y.; Hisel, Terri Z.; Makowski, Nathaniel S.; Fu, Michael J.; Chae, John

2012-01-01

Contralaterally controlled functional electrical stimulation (CCFES) is an innovative method of delivering neuromuscular electrical stimulation for rehabilitation of paretic limbs after stroke. It is being studied to evaluate its efficacy in improving recovery of arm and hand function and ankle dorsiflexion in chronic and subacute stroke patients. The initial studies provide preliminary evidence supporting the efficacy of CCFES. PMID:23365893

The Impact of Simulation on Pediatric Nursing Students' Knowledge, Self-Efficacy, Satisfaction, and Confidence

ERIC Educational Resources Information Center

Saied, Hala

2017-01-01

The simulation technology is rapidly expanding and has been used in several nursing programs around the world and in Saudi Arabia too. The aim of this study was to evaluate the effect of using a simulation based scenarios on the pediatric nursing students' students' knowledge, self-efficacy, satisfaction, and confidence. This study used Bandura's…

[Research and development on efficacy of Chinese herbal compound].

PubMed

Liu, Jian-Xun; Ren, Jian-Xun; Lin, Cheng-Ren

2016-03-01

The efficacy not only is summarized by clinical effect of Chinese herbal compound on theory of traditional Chinese medicine, but also is manifested to clinical effect by interaction of many intricate chemical substances. The efficacy of Chinese herbal compound is current research focus in field of traditional Chinese medicine. By currently knowing in different aspects which included the progression in efficacy of Chinese herbal compound, symptomatic efficacy of Chinese herbal compound, the relationship between the efficacy and pharmacologic effect of Chinese herbal compound, the efficacy related pharmacodynamic substance and the evaluation of efficacy, it had been summarized mainly problems and methods in research and development process of the efficacy of Chinese herbal compound in this paper. Paper also elucidated problems that need to pay attention in research of efficacy in order to provide references for clinical and experimental studies of efficacy in Chinese herbal compound, boost research and development level of new traditional Chinese drug and facilitate modernization of traditional Chinese medicines. Copyright© by the Chinese Pharmaceutical Association.

The efficacy of a first aid training course for drivers: an experience from northern Iran.

PubMed

Vakili, Mohammad Ali; Mohjervatan, Ali; Heydari, Seyed Taghi; Akbarzadeh, Armin; Hosini, Nazanin Sadat; Alizad, Farideh; Arasteh, Peyman; Moghasemi, Mohammad Javad

2014-01-01

To evaluate the efficacy of a first aid training course for a group of drivers. This study comprised 500 drivers, randomly selected from the road transport companies. They underwent a course of first aid training and the results were evaluated at 0-3 and 4-6 months after training. Both quantitative and qualitative improvements were observed in the drivers'efficacy in giving first aid. Also the rate of correct interventions was higher at 4-6 months than at 0-3 months. The exception was airway management which was not favorably improved after training. The first aid training course for drivers is beneficial and helpful for prehospital care system in road traffic accidents.

Efficacy and safety of a lindane 1% treatment regimen for scabies, confirmed by dermoscopy-guided skin scraping with microscopic examination.

PubMed

Park, S E; Her, Y; Kim, S S; Kim, C W

2015-08-01

This is the first study investigating scabies treatment since 1992 to involve examination of patients with microscopically confirmed scabies. To assess the efficacy of 1% lindane cream in treating microscopically confirmed scabies, and to determine the utility of dermoscopy-guided skin scraping with microscopic examination (DSGSS-ME) in evaluating the efficacy of scabies treatment. This retrospective study analysed patients treated for scabies between January 2012 and December 2013. From the hospital database, 287 cases of scabies were identified and 50 were enrolled in the study. Patients were treated with 1% lindane cream twice weekly (days 0 and 1) and were evaluated with DSGSS-ME on day 7. Treatment and evaluations were repeated once weekly until a negative DSGSS-ME result was obtained. The cumulative efficacy of lindane 1% cream was 40% (20/50) after 1 week, 88% (44/50) after 2 weeks and 98% (49/50) after 3 weeks of treatment. There was a statistically significant difference between the 1- and 2-week (P = 0.03), and 1- and 3-week (P = 0.02) treatments. A total of 90 post-treatment DSGSS-MEs were performed, with a sensitivity of 97.3% (95% CI 85.8-99.9) and a negative predictive value of 98.2% (95% CI 90.1-100). Specificity and positive predictive value were 100%, as this procedure cannot yield false-positive results, because it relies on finding mites, eggs or faeces. We suggest that a twice-weekly schedule (on consecutive days) of 1% lindane treatment lasting at least 2 weeks is required to clear scabies. DSGSS-ME appears to be a good method to evaluate the efficacy of scabies treatment. This study introduces a safe and effective method to treat scabies, and to accurately monitor infestation status in patients. © 2015 British Association of Dermatologists.

2-Year Efficacy, Immunogenicity, and Safety of Vigoo Enterovirus 71 Vaccine in Healthy Chinese Children: A Randomized Open-Label Study.

PubMed

Wei, Mingwei; Meng, Fanyue; Wang, Shiyuan; Li, Jingxin; Zhang, Yuntao; Mao, Qunying; Hu, Yuemei; Liu, Pei; Shi, Nianmin; Tao, Hong; Chu, Kai; Wang, Yuxiao; Liang, Zhenglun; Li, Xiuling; Zhu, Fengcai

2017-01-01

 This study evaluated the 2-year efficacy, immunogenicity, and safety of the Vigoo enterovirus 71 (EV71) vaccine.  In an initial phase 3 study, we randomly assigned healthy infants and children aged 6-35 months (ratio, 1:1) to receive 2 doses of either EV71 vaccine (5120 participants) or placebo (5125 participants) at days 0 and 28, and followed them for 12 months after vaccination. In this extended follow-up study, we continued to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine for up to 2 years.  Overall efficacy was 94.84% (95% confidence interval [CI], 83.53%-98.38%) during the 2-year follow-up period (P < .0001), and the vaccine efficacy during the second year was 100.00% (95% CI, 84.15%-100.00%) against EV71-associated hand-foot-and-mouth disease (HFMD; P < .0001). Geometric mean titers of neutralizing antibody in participants remained high during the 2-year follow-up period, and no vaccine-related serious adverse events were recorded.  Two doses of Vigoo EV71 vaccine could provide sustained protection against EV71-associated HFMD in healthy Chinese children.  NCT01508247. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Clinical efficacy and economic evaluation of online cognitive behavioral therapy for major depressive disorder: a systematic review and meta-analysis.

PubMed

Ahern, Elayne; Kinsella, Stephen; Semkovska, Maria

2018-02-01

Leading cause of disability worldwide, depression is the most prevalent mental disorder with growing societal costs. As mental health services demand often outweighs provision, accessible treatment options are needed. Our systematic review and meta-analysis evaluated the clinical efficacy and economic evidence for the use of online cognitive behavioral therapy (oCBT) as an accessible treatment solution for depression. Areas covered: Electronic databases were searched for controlled trials published between 2006 and 2016. Of the reviewed 3,324 studies, 29 met the criteria for inclusion in the efficacy meta-analysis. The systematic review identified five oCBT economic evaluations. Therapist-supported oCBT was equivalent to face-to-face CBT at improving depressive symptoms and superior to treatment-as-usual, waitlist control, and attention control. Depression severity, number of sessions, or support did not affect efficacy. From a healthcare provider perspective, oCBT tended to show greater costs with greater benefits in the short term, relative to comparator treatments. Expert commentary: Although efficacious, further economic evidence is required to support the provision of oCBT as a cost-effective treatment for depression. Economic evaluations that incorporate a societal perspective will better account for direct and indirect treatment costs. Nevertheless, oCBT shows promise of effectively improving depressive symptoms, considering limited mental healthcare resources.

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.

Development and evaluation of a psychoeducation practitioner training program (PPTP).

PubMed

Matsuda, Mitsunobu; Kono, Ayumi

2015-08-01

The objective of this study was to develop a psychoeducation practitioner training program (PPTP) and to evaluate its usefulness with regard to nursing competencies (knowledge, self-efficacy, attitude, motivation, skills). A mixed-method research design was applied in this study. Some of the quantitative data were a one-group pretest-posttest study. Forty nurses participated in the PPTP, of whom 38 (17 men and 21 women) completed a 2-consecutive-day curriculum (dropout rate: 5%). The PPTP significantly improved nurses' knowledge of, self-efficacy for, and attitude toward psychoeducation. However, the program did not lead to the acquisition of psychoeducational skills. Copyright © 2015 Elsevier Inc. All rights reserved.

Benchmarks for Psychotherapy Efficacy in Adult Major Depression

ERIC Educational Resources Information Center

Minami, Takuya; Wampold, Bruce E.; Serlin, Ronald C.; Kircher, John C.; Brown, George S.

2007-01-01

This study estimates pretreatment-posttreatment effect size benchmarks for the treatment of major depression in adults that may be useful in evaluating psychotherapy effectiveness in clinical practice. Treatment efficacy benchmarks for major depression were derived for 3 different types of outcome measures: the Hamilton Rating Scale for Depression…

Efficacy of an Emotion-Focused Treatment for Prolonged Fatigue

ERIC Educational Resources Information Center

Schutte, Nicola S.; Malouff, John M.; Brown, Rhonda F.

2008-01-01

Previous research findings have suggested a relationship between less adaptive emotional functioning and fatigue. The present study used a research design involving multiple baselines across participants to evaluate the efficacy of a new emotion-focused treatment for prolonged fatigue delivered in a cognitive behavioral therapy framework. The 13…

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…

Enhancing Entrepreneurial Self-Efficacy through Vocational Entrepreneurship Education Programmes

ERIC Educational Resources Information Center

Maritz, Alex; Brown, Chris

2013-01-01

The purpose of this study is to report the results of a longitudinal evaluation of a vocational entrepreneurship education programme (EEP) using entrepreneurial self-efficacy (ESE) measures. An empirical, mixed methods longitudinal and effectuation scale was used to measure ESE scores. Results indicate that participation in the programme had a…

Efficacy of a live attenuated Edwardsiella ictaluri oral vaccine in channel and hybrid catfish

USDA-ARS?s Scientific Manuscript database

Intensive fish production systems resort to higher stocking densities and feeding rates in culture conditions to manifest suboptimal conditions to facilitate disease outbreaks leading to production losses. This study was conducted to evaluate the efficacy of an oral live-attenuated Edwardsiella ict...

Treatment of Depression and Suicide in Older Adults

ERIC Educational Resources Information Center

Bhar, Sunil S.; Brown, Gregory K.

2012-01-01

This article describes a cognitive behavior therapy (CBT) intervention for suicide prevention in older adults. Although many studies have found that CBT interventions are efficacious for reducing depressive symptoms in the elderly, researchers have yet to evaluate the efficacy of such interventions for preventing suicide or reducing suicide risk…

Phonological Treatment Efficacy and Developmental Norms.

ERIC Educational Resources Information Center

Gierut, Judith A.; And Others

1996-01-01

Two studies, one within subjects and the other across subjects, evaluated the efficacy of teaching sounds in developmental sequence to nine young children (ages three to five). Treatment of later-acquired phonemes led to systemwide changes in untreated sound classes, whereas treatment of early-acquired phonemes did not. Findings suggest…

Anger expression, self-efficacy and interpersonal competency of Korean nursing students.

PubMed

Jun, W-H

2016-12-01

The purpose of this study was to determine whether self-efficacy mediated the relationship between anger expression and interpersonal competency in South Korean nursing students. Interpersonal competency allows nursing students to increase their self-confidence in caring for patients. There is evidence of complex relationships between anger expression, self-efficacy and interpersonal competency. Self-efficacy could be considered a potential mediator in the association between anger expression and interpersonal competency in nursing students. However, few studies have investigated the mediatory role of self-efficacy in this association. A descriptive, cross-sectional study was conducted. In total, 207 Korean nursing students completed a structured questionnaire. Measurement tools included the State-Trait Anger Expression Inventory, Self-efficacy Scale and Interpersonal Competence Questionnaire. Significant correlations were observed between anger expression, self-efficacy and interpersonal competency. Self-efficacy exerted a partial mediatory effect on the relationships between interpersonal competency and anger-in and anger-control within the anger expression subscales. The study demonstrated that appropriate anger expression could result in enhanced interpersonal competency via an increase in self-efficacy. The results concerning the mediatory role of self-efficacy in the association between anger expression and interpersonal competency have provided new knowledge for nursing educators, managers and researchers, allowing them to support nursing students' interpersonal competency. Nursing schools should be required to evaluate students' anger expression patterns and to increase self-efficacy when developing education programmes that provide interpersonal training for nursing students. © 2016 International Council of Nurses.

Efficacy and safety of imidacloprid/moxidectin spot-on solution and fenbendazole in the treatment of dogs naturally infected with Angiostrongylus vasorum (Baillet, 1866).

PubMed

Willesen, J L; Kristensen, A T; Jensen, A L; Heine, J; Koch, J

2007-07-20

A randomized, blinded, controlled multicentre field trial study was conducted to evaluate the efficacy and safety of imidacloprid 10%/moxidectin 2.5% spot-on solution and fenbendazole in treating dogs naturally infected with Angiostrongylus vasorum. Dogs were randomly treated either with a single dose of 0.1 ml/kg bodyweight of imidacloprid 10%/moxidectin 2.5% spot-on solution or with 25 mg/kg bodyweight fenbendazole per os for 20 days. The study period was 42 days with dogs being examined on days 0, 7 and 42. The primary efficacy parameter was the presence of L1 larvae in faecal samples evaluated by a Baermann test from three consecutive days. Thoracic radiographs performed on each visit were being taken as a paraclinical parameter to support the results of the Baermann test. Twenty-seven dogs in the imidacloprid/moxidectin group and 23 dogs in the fenbendazole group completed the study according to protocol. The efficacies of the two treatment protocols were 85.2% (imidacloprid/moxidectin) and 91.3% (fenbendazole) with no significant difference between treatment groups. On radiographic evaluation pulmonary parenchyma showed similar improvement in each group. No serious adverse effects to treatment were recorded: most of the minor adverse effects were gastrointestinal such as diarrhea (nine dogs), vomitus (eight dogs) and salivation (three dogs). In general, these adverse effects were of short duration (1-2 days) within the first few days after treatment start and required little or no treatment. This prospective study demonstrates that both treatment protocols used are efficacious under field conditions, that treatment of mildly to moderately infected dogs with either of these protocols is safe and yields an excellent prognosis for recovering from the infection.

Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem.

PubMed

Roehrs, Timothy A; Roth, Thomas

2016-03-01

Studies have shown pharmacokinetic differences for hypnotics in women compared to men, but few studies have assessed either short-or long-term differences in efficacy and safety. To evaluate gender differences in the efficacy and safety of chronic nightly zolpidem (10 mg), we did a post hoc assessment of a large clinical trial. In the trial, participants with primary insomnia (n = 89), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia were randomized, double blind, to nightly zolpidem, 10 mg (n = 47) or placebo (n = 42) 30 minutes before bedtime nightly for 12 months. Polysomnographic sleep on 2 nights in months 1 and 8 and likelihood of next-day sleepiness, rebound insomnia, and dose escalation were evaluated in months 1, 4, and 12. Relative to placebo, zolpidem significantly increased sleep efficiency and reduced sleep latency and wake after sleep onset assessed at months 1 and 8, with no differences in efficacy between women and men and no diminution of efficacy over months. On a next-day multiple sleep latency test (MSLT), no residual sedation was observed for either women or men. No rebound insomnia or dose escalation was seen with no gender differences in either. In adults with primary insomnia, nightly zolpidem administration showed no gender differences in acute or chronic efficacy or in next-day sleepiness. Zolpidem remained efficacious and safe across 12 months. CLINCIAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525. © 2016 American Academy of Sleep Medicine.

The Effect of Special Teaching Methods Class on the Level of Teachers' Self-Efficacy Perception of Pre-Service Teacher

ERIC Educational Resources Information Center

Gökdag Baltaoglu, Meltem

2015-01-01

The purpose of this study is to evaluate the change in the level of teachers' self-efficacy perception of primary school Social Studies pre-service teachers who take the special teaching methods class. Single group pretest-posttest model from pre-experimental patterns was applied in the research. The study group of the research consisted of 59…

[Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections].

PubMed

Ma, Ling; Zhang, Yuan-Zhen; Zheng, Yi-Lin; Wang, Ze-Hua; Xu, You-di; Kong, Li-Na

2010-10-01

to evaluate clinical efficacy and safety of levornidazole in the treatment of pelvic anaerobic infections. a multicenter randomized controlled clinical study was conducted to evaluate clinical efficacy and safety of levornidazole. One hundred and fourty-three patients with pelvic anaerobic bacteria infection were classified into 70 cases treated by levornidazole in study group and 73 cases treated by Ornidazole in control group. Those patients in two groups were both administered at a dose of 0.5 g twice daily for 5 - 7 days. The rate of clinical efficacy, bacteria clearance and adverse effect were recorded and compared between two groups. at the endpoint, the rate of clinical efficacy were 80% (56/70) in study group and 81% (59/73) in control group, which did not reach significant difference (P > 0.05). The rate of bacteria clearance were 97% (36/37) in study group and 92% (22/24) in control group, which also did not reach significant difference (P > 0.05). The rate of adverse reaction of 3% (20/70) in study group was significantly lower than 22% (16/73) in control group (P < 0.05). it is effective and safe to treat pelvic anaerobic infections with levornidazole and sodium chloride injection.

The effects of a computer skill training programme adopting social comparison and self-efficacy enhancement strategies on self-concept and skill outcome in trainees with physical disabilities.

PubMed

Tam, S F

2000-10-15

The aim of this controlled, quasi-experimental study was to evaluate the effects of both self-efficacy enhancement and social comparison training strategy on computer skills learning and self-concept outcome of trainees with physical disabilities. The self-efficacy enhancement group comprised 16 trainees, the tutorial training group comprised 15 trainees, and there were 25 subjects in the control group. Both the self-efficacy enhancement group and the tutorial training group received a 15 week computer skills training course, including generic Chinese computer operation, Chinese word processing and Chinese desktop publishing skills. The self-efficacy enhancement group received training with tutorial instructions that incorporated self-efficacy enhancement strategies and experienced self-enhancing social comparisons. The tutorial training group received behavioural learning-based tutorials only, and the control group did not receive any training. The following measurements were employed to evaluate the outcomes: the Self-Concept Questionnaire for the Physically Disabled Hong Kong Chinese (SCQPD), the computer self-efficacy rating scale and the computer performance rating scale. The self-efficacy enhancement group showed significantly better computer skills learning outcome, total self-concept, and social self-concept than the tutorial training group. The self-efficacy enhancement group did not show significant changes in their computer self-efficacy: however, the tutorial training group showed a significant lowering of their computer self-efficacy. The training strategy that incorporated self-efficacy enhancement and positive social comparison experiences maintained the computer self-efficacy of trainees with physical disabilities. This strategy was more effective in improving the learning outcome (p = 0.01) and self-concept (p = 0.05) of the trainees than the conventional tutorial-based training strategy.

Evaluation of AISI Type 304 stainless steel as a suitable surface material for evaluating the efficacy of peracetic acid-based disinfectants against Clostridium difficile spores.

PubMed

Black, Elaine; Owens, Krista; Staub, Richard; Li, Junzhong; Mills, Kristen; Valenstein, Justin; Hilgren, John

2017-01-01

Disinfectants play an important role in controlling microbial contamination on hard surfaces in hospitals. The effectiveness of disinfectants in real life can be predicted by laboratory tests that measure killing of microbes on carriers. The modified Quantitative Disk Carrier Test (QCT-2) is a standard laboratory method that employs American Iron and Steel Institute (AISI) Type 430 stainless steel carriers to measure hospital disinfectant efficacy against Clostridium difficile spores. The formation of a rust-colored precipitate was observed on Type 430 carriers when testing a peracetic acid (PAA)-based disinfectant with the QCT-2 method. It was hypothesized that the precipitate was indicative of corrosion of the Type 430 carrier, and that corrosion could impact efficacy results. The objective of this study was to compare the suitability of AISI Type 430 to Type 304 stainless steel carriers for evaluating PAA-based disinfectants using the QCT-2 method. Type 304 is more corrosion-resistant than Type 430, is ubiquitous in healthcare environments, and is used in other standard methods. Suitability of the carriers was evaluated by comparing their impacts on efficacy results and PAA degradation rates. In efficacy tests with 1376 ppm PAA, reductions of C. difficile spores after 5, 7 and 10 minutes on Type 430 carriers were at least about 1.5 log10 lower than reductions on Type 304 carriers. In conditions simulating a QCT-2 test, PAA concentration with Type 430 carriers was reduced by approximately 80% in 10 minutes, whereas PAA concentration in the presence of Type 304 carriers remained stable. Elemental analyses of residues on each carrier type after efficacy testing were indicative of corrosion on the Type 430 carrier. Use of Type 430 stainless steel carriers for measuring the efficacy of PAA-based disinfectants should be avoided as it can lead to an underestimation of real life sporicidal efficacy. Type 304 stainless steel carriers are recommended as a suitable alternative.

Evaluation of AISI Type 304 stainless steel as a suitable surface material for evaluating the efficacy of peracetic acid-based disinfectants against Clostridium difficile spores

PubMed Central

Owens, Krista; Staub, Richard; Li, Junzhong; Mills, Kristen; Valenstein, Justin; Hilgren, John

2017-01-01

Disinfectants play an important role in controlling microbial contamination on hard surfaces in hospitals. The effectiveness of disinfectants in real life can be predicted by laboratory tests that measure killing of microbes on carriers. The modified Quantitative Disk Carrier Test (QCT-2) is a standard laboratory method that employs American Iron and Steel Institute (AISI) Type 430 stainless steel carriers to measure hospital disinfectant efficacy against Clostridium difficile spores. The formation of a rust-colored precipitate was observed on Type 430 carriers when testing a peracetic acid (PAA)-based disinfectant with the QCT-2 method. It was hypothesized that the precipitate was indicative of corrosion of the Type 430 carrier, and that corrosion could impact efficacy results. The objective of this study was to compare the suitability of AISI Type 430 to Type 304 stainless steel carriers for evaluating PAA-based disinfectants using the QCT-2 method. Type 304 is more corrosion-resistant than Type 430, is ubiquitous in healthcare environments, and is used in other standard methods. Suitability of the carriers was evaluated by comparing their impacts on efficacy results and PAA degradation rates. In efficacy tests with 1376 ppm PAA, reductions of C. difficile spores after 5, 7 and 10 minutes on Type 430 carriers were at least about 1.5 log10 lower than reductions on Type 304 carriers. In conditions simulating a QCT-2 test, PAA concentration with Type 430 carriers was reduced by approximately 80% in 10 minutes, whereas PAA concentration in the presence of Type 304 carriers remained stable. Elemental analyses of residues on each carrier type after efficacy testing were indicative of corrosion on the Type 430 carrier. Use of Type 430 stainless steel carriers for measuring the efficacy of PAA-based disinfectants should be avoided as it can lead to an underestimation of real life sporicidal efficacy. Type 304 stainless steel carriers are recommended as a suitable alternative. PMID:29065168

78 FR 68461 - Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-14

...] Guidance for Industry: Studies To Evaluate the Utility of Anti- Salmonella Chemical Food Additives in Feeds... Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds,'' and is... of Anti-Salmonella Chemical Food Additives in Feeds (GFI 80) is to help sponsors design efficacy...

Mathematics interventions for children and adolescents with Down syndrome: a research synthesis.

PubMed

Lemons, C J; Powell, S R; King, S A; Davidson, K A

2015-08-01

Many children and adolescents with Down syndrome fail to achieve proficiency in mathematics. Researchers have suggested that tailoring interventions based on the behavioural phenotype may enhance efficacy. The research questions that guided this review were (1) what types of mathematics interventions have been empirically evaluated with children and adolescents with Down syndrome?; (2) do the studies demonstrate sufficient methodological rigor?; (3) is there evidence of efficacy for the evaluated mathematics interventions?; and (4) to what extent have researchers considered aspects of the behavioural phenotype in selecting, designing and/or implementing mathematics interventions for children and adolescents with Down syndrome? Nine studies published between 1989 and 2012 were identified for inclusion. Interventions predominantly focused on early mathematics skills and reported positive outcomes. However, no study met criteria for methodological rigor. Further, no authors explicitly considered the behavioural phenotype. Additional research using rigorous experimental designs is needed to evaluate the efficacy of mathematics interventions for children and adolescents with Down syndrome. Suggestions for considering the behavioural phenotype in future research are provided. © 2015 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

Evaluation of salicylic acid peeling in comparison with topical tretinoin in the treatment of postinflammatory hyperpigmentation.

PubMed

Mohamed Ali, Basma Morad; Gheida, Shereen Farouk; El Mahdy, Nageh Ahmed; Sadek, Shery Nashaat

2017-03-01

Postinflammatory hyperpigmentation (PIH) is an acquired hyperpigmentation that involves areas of prior cutaneous inflammation. In addition to prevention, there are a variety of medications and procedures used to treat PIH. The aim of this work was to evaluate the efficacy, tolerability, and safety of salicylic acid peeling in comparison with topical tretinoin in the treatment of PIH. This study included forty-five patients with PIH lesions. The patients were divided into three groups, group I was treated with salicylic acid peeling 20-30%, group II was treated with topical tretinoin 0.1%, and group III was treated with combination of salicylic acid peel and topical tretinoin. The patients were assessed clinically to evaluate the efficacy, tolerability, and safety of the treatment. Dermoscopy was carried out to the recurrent or nonimproved cases only. Combination of salicylic acid peel and topical tretinoin treatment showed significant clinical improvement of PIH than each treatment alone with no complications. There was no significant difference in the recurrence rate between the three groups. There was nonsignificant difference between the efficacy of the treatment and the PIH type in the studied groups. There was nonsignificant difference between the efficacy of the treatment and the duration of the PIH except for group III. Combination treatment modality is believed to be preferred in the treatment of PIH due to its higher efficacy than single treatment alone, with well tolerability, less side effects, and low recurrence rate. © 2016 Wiley Periodicals, Inc.

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.

Assessment of the efficacy and safety profiles of aspirin and acetaminophen with codeine: results from 2 randomized, controlled trials in individuals with tension-type headache and postoperative dental pain.

PubMed

Gatoulis, Sergio C; Voelker, Michael; Fisher, Matt

2012-01-01

Aspirin is a widely used NSAID that has been extensively studied in numerous conditions. Nonprescription analgesics, such as aspirin, are frequently used for a wide variety of common ailments, including conditions such as dental pain and tension-type headache. We sought to compare the efficacy and safety profiles of aspirin, acetaminophen with codeine, and placebo in the treatment of post-operative dental pain and tension-type headache. These were 2 randomized, double-blind, placebo-controlled, single-dose clinical trials that assigned participants (2:2:1) to receive either aspirin (1000 mg), acetaminophen (300 mg) with codeine (30 mg), or placebo. The primary efficacy end point was the sum of pain intensity differences from baseline (SPID) over 6 hours for the dental pain study and over 4 hours for the tension-type headache study. Other common analgesic measures, in addition to safety, were also evaluated. The results of the dental pain study for aspirin and acetaminophen with codeine suggest statistically significant efficacy for all measures compared with placebo at all time points. Aspirin provided statistically significant efficacy compared with acetaminophen with codeine for SPID(0-4) (P = 0.028). In the tension-type headache study, aspirin and acetaminophen with codeine provided statistically significant efficacy compared with placebo for SPID(0-4) and SPID(0-6) (P < 0.001) and for total pain relief (P < 0.001). There were no significant differences between aspirin and acetaminophen with codeine at any evaluation of SPID (P ≥ 0.070), complete relief (P ≥ 0.179), or time to meaningful relief (P ≥ 0.245). Regarding safety, there were no statistically significant differences between treatment groups in the incidence of adverse events in the dental pain and tension-type headache studies. These 2 randomized, double-blind, placebo-controlled studies demonstrate that treatment with aspirin (1000 mg) provides statistically significant analgesic efficacy compared with placebo use and comparable efficacy with acetaminophen (300 mg) with codeine (30 mg) therapy after impacted third molar extraction and in tension- type headache. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

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.

French version of the Copenhagen neck functional disability scale.

PubMed

Forestier, Romain; Françon, Alain; Arroman, Frédérique Saint; Bertolino, Christiane

2007-03-01

We conducted a study to validate the French version of the Copenhagen Neck Functional Disability Scale (CNFDS). We used the CNFDS on data generated by a previous randomized controlled trial comparing pulsed electromagnetic field therapy (PEMFT), spa therapy, and standard therapy in patients with neck pain. Patients were recruited locally and examined by a physician who was unaware of the treatment group and independent from the trial. Treatment efficacy was evaluated based on a visual analog scale (VAS) for pain, the short-form-36 quality-of-life instrument (SF36), payments by public healthcare insurance, and overall assessments by the patients and physicians. Efficacy was evaluated at baseline, at treatment completion, and after 3 and 6 months. In addition, the patients completed the CNFDS at these time points. CNFDS scores were normally distributed. CNFDS scores and their variations correlated well with the other efficacy criteria. CNFDS scores were less sensitive to change than the VAS pain scores and more sensitive to change than the other efficacy criteria. The CNFDS holds promise as a tool for evaluating neck pain. Score reproducibility needs to be studied. The CNFDS can be added to the other instruments that have been translated in recent years to serve as tools for clinical research. However, the ease of completion of the CNFDS is consistent with use in clinical practice.

Assessment of treatment efficacy and sebosuppressive effect of fractional radiofrequency microneedle on acne vulgaris.

PubMed

Lee, Kyung Real; Lee, Eo Gin; Lee, Hee Jung; Yoon, Moon Soo

2013-12-01

A minimally invasive fractional radiofrequency microneedle (FRM) device has been used in skin rejuvenation and acne scars, and a recent pilot study demonstrated the positive therapeutic effect on acne. We evaluated the efficacy of FRM device for acne vulgaris in Asians and conducted objective measurement to assess its effect on sebum production. Twenty Korean patients with acne vulgaris received a single full-face FRM treatment. Outcome assessments included standardized photography, physician's global assessment, patient's satisfaction scores, acne lesion count, and objective measurements of casual sebum level (CSL) and sebum excretion rate (SER). They were evaluated at baseline and 2, 4, 8 weeks after the treatment. After a single FRM treatment, the CSL and the SER showed 30-60% and 70-80% reduction, respectively, at week 2 (P < 0.01), and remained below the baseline level until week 8. Physician's global improvement scores for acne severity and acne lesion count also revealed clinical improvement with maximum efficacy at week 2, but returned to the baseline in most patients by week 8. Patients' satisfaction scores (0-4) were above 2 on average, and adverse effects were minimal. This prospective study demonstrated the sebosuppressive effect from a single FRM treatment, but its therapeutic efficacy in acne requires further evaluation. © 2013 Wiley Periodicals, Inc.

Analysis of difficulties in mathematics problem solving based on revised Bloom’s Taxonomy viewed from high self-efficacy

NASA Astrophysics Data System (ADS)

Prismana, R. D. E.; Kusmayadi, T. A.; Pramudya, I.

2018-04-01

The ability of solving problem is a part of the mathematic curriculum that is very important. Problem solving prefers the process and strategy that is done by students in solving a problem rather than the result. This learning concept in accordance with the stages on the revised bloom’s taxonomy. The revised Bloom’s Taxonomy has two dimensions, namely the dimension of cognitive process and the dimension of knowledge. Dimension of knowledge has four categories, but this study only restricted on two knowledge, conceptual knowledge and procedural knowledge. Dimensions of cognitive processes are categorized into six kinds, namely remembering, understanding, applying, analyzing, evaluating, and creating. Implementation of learning more emphasis on the role of students. Students must have their own belief in completing tasks called self-efficacy. This research is a qualitative research. This research aims to know the site of the students’ difficulty based on revised Bloom’s Taxonomy viewed from high self-efficacy. The results of the study stated the students with high self efficacy have difficulties site. They are evaluating conceptual knowledge, evaluating procedural knowledge, creating conceptual knowledge, and creating procedural knowledge. It could be the consideration of teachers in the teaching, so as to reduce the difficulties of learning in students.

Cognitive and personality factors in the delay of gratification of hemodialysis patients.

PubMed

Rosenbaum, M; Ben-Ari Smira, K

1986-08-01

On the basis of Mischel's (1984) social learning analysis of the process of delay of gratification in children and in line with Bandura's (1977) self-efficacy theory, we developed a model of delay of gratification in adults and tested it on dialysis patients who were continuously required to comply with a stringent regimen of fluid-intake to keep alive. We hypothesized that patients' self-evaluations of their past compliance and their efficacy expectations would be associated with their actual delay behavior. Underlying these process-regulating cognitions would be stable competencies, such as learned resourcefulness (i.e., one's self-control skills). Fifty-three dialysis patients self-evaluated their fluid intake compliance, their efficacy expectations, and their health beliefs. Resourcefulness was assessed by Rosenbaum's Self-Control Schedule. Actual fluid-intake compliance was reliably assessed by the mean body weight increase between dialyses during the 3-month period prior to the study and during two follow-up periods. The results supported the model. On the one hand, self-efficacy expectations were related to persistence with the fluid diet and on the other hand to subjects' self-evaluation of their past adherence behavior as well as to their resourcefulness. Although the path model suggested a causal pattern, the correlational nature of the study precluded any conclusions on cause-effect relationship.

Efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye: a systematic review of randomized clinical trials.

PubMed

Wu, Di; Chen, Wang Qi; Li, Ryan; Wang, Yan

2015-06-01

To evaluate the efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye. Randomized clinical trials (RCTs) from MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were identified to evaluate the efficacy and safety of topical administration of diquafosol to patients with dry eyes. Data evaluation was based on endpoints including Schirmer test, tear film break-up time, ocular surface staining score, subjective symptom score, and adverse events. A total of 8 RCTs involving 1516 patients were selected based on the prespecified criteria. Significant improvement of Schirmer test values and tear film break-up time were reported in 40% (2 of 5) and 80% (4 of 5) studies, respectively. Ocular surface staining scores significantly decreased in 100% (fluorescein corneal staining, 6 of 6; Rose Bengal corneal and conjunctival staining, 4 of 4) RCTs. Symptoms significantly improved in 75% (6 of 8) RCTs in patients with dry eyes. No severe adverse events were reported with the concentration of diquafosol from 0.5% to 5%. Heterogeneity in study design prevented meta-analysis from statistical integration and summarization. Topical diquafosol seems to be a safe therapeutic option for the treatment of dry eye. The high variability of the selected RCTs compromised the strength of evidence and limits the determination of efficacy. However, the topical administration of diquafosol seems to be beneficial in improving the integrity of the epithelial cell layer of the ocular surface and mucin secretion in patients with dry eyes. This review indicates a need for standardized criteria and methods for evaluation to assess the efficacy of diquafosol in the future clinical trials.

Immune protection duration and efficacy stability of DNA vaccine encoding Eimeria tenella TA4 and chicken IL-2 against coccidiosis.

PubMed

Song, Xiaokai; Zhao, Xiaofang; Xu, Lixin; Yan, Ruofeng; Li, Xiangrui

2017-04-01

In our previous study, an effective DNA vaccine encoding Eimeria tenella TA4 and chicken IL-2 was constructed. In the present study, the immunization dose of the DNA vaccine pVAX1.0-TA4-IL-2 was further optimized. With the optimized dose, the dynamics of antibodies induced by the DNA vaccine was determined using indirect ELISA. To evaluate the immune protection duration of the DNA vaccine, two-week-old chickens were intramuscularly immunized twice and the induced efficacy was evaluated by challenging with E. tenella at 5, 9, 13, 17 and 21weeks post the last immunization (PLI) separately. To evaluate the efficacy stability of the DNA vaccine, two-week-old chickens were immunized with 3 batches of the DNA vaccine, and the induced efficacy was evaluated by challenging with E. tenella. The results showed that the optimal dose was 25μg. The induced antibody level persisted until 10weeks PPI. For the challenge time of 5 and 9weeks PLI, the immunization resulted in ACIs of 182.28 and 162.23 beyond 160, showing effective protection. However, for the challenge time of 13, 17 and 21weeks PLI, the immunization resulted in ACIs below 160 which means poor protection. Therefore, the immune protection duration of the DNA vaccination was at least 9weeks PLI. DNA immunization with three batches DNA vaccine resulted in ACIs of 187.52, 191.57 and 185.22, which demonstrated that efficacies of the three batches DNA vaccine were effective and stable. Overall, our results indicate that DNA vaccine pVAX1.0-TA4-IL-2 has the potential to be developed as effective vaccine against coccidiosis. Copyright © 2016 Elsevier Ltd. All rights reserved.

Economic burden of psoriatic patients in Japan: Analysis from a single outpatient clinic.

PubMed

Takahashi, Hidetoshi; Satoh, Katsuhiko; Takagi, Akiyoshi; Iizuka, Hajime

2017-09-01

Topical and systemic agents have dramatically improved the treatment efficacy of psoriasis. Few reports, however, exist describing the economic burden in Japanese psoriatic patients. The aim of the study was to evaluate the total costs as well as cost versus efficacy of topical and systemic treatments of psoriatic patients under the Japanese health insurance system. The retrospective study was performed from the database of our clinic, which is located in Hokkaido Prefecture. Cost and effectiveness of psoriatic patients were evaluated during the 12-month period from April 2015 to March 2016. Data were collected and calculated for the total cost per year, treatment efficacy and cost versus efficacy. The mean total cost of topical corticosteroid treatment was ¥18 184/year and was lowest among the treatments. The systemic treatment with biologics was most expensive and the costs were over ¥400 000/year. Among the topical treatments, calcipotriol/betamethasone dipropionate was most expensive (¥34 693/year). However, cost versus efficacy was not significantly different from that of topical corticosteroid treatments. The cost of secukinumab was highest among all the treatments (¥631 600/year). However, treatment day per cost was lowest of all the psoriasis treatments. Biologics showed the highest cost than topical or systemic treatments. However, they showed most marked efficacy in terms of improving the psoriatic skin lesions. © 2017 Japanese Dermatological Association.

The Role of Teachers' Emotional Intelligence and Self-Efficacy in Decreasing Students' Separation Anxiety Disorder

ERIC Educational Resources Information Center

Masoumparast, Shiva

2016-01-01

Background: teachers are as responsible for personal progress of children as parents are for their nurturing. The purpose of this study is to examine the role of EI and self-efficacy of teachers in reduced SAD of primary school students in Tehran. In other words, this study evaluates the effective role of teachers in reducing SAD in students.…

Validity and Reliability of a Parental Self-Efficacy Instrument in the Healthy School Start Prevention Trial of Childhood Obesity

ERIC Educational Resources Information Center

Bohman, Benjamin; Nyberg, Gisela; Sundblom, Elinor; Schäfer Elinder, Liselotte

2014-01-01

Introduction: Measures of parental self-efficacy (PSE) for healthy dietary or physical activity (PA) behaviors in children have been used in several studies; however, further psychometric validation of PSE for these behaviors is needed. The purpose of the present study was to evaluate the psychometric properties of a new PSE instrument. Methods:…

PKU and Maternal PKU: The Cure and the Problem.

ERIC Educational Resources Information Center

Henderson, Robert A.

1989-01-01

A longitudinal study is evaluating the efficacy of a phenylalanine-restricted diet in reducing disabling conditions associated with maternal hyperphenylalaninemia. Titled the Maternal PKU Collaborative Study, it is studying 162 American and Canadian women and involves diet therapy, prenatal examinations, laboratory tests, nutritional evaluation,…

Efficacy of an Intervention to Reduce the Use of Media Violence and Aggression: An Experimental Evaluation with Adolescents in Germany

ERIC Educational Resources Information Center

Moller, Ingrid; Krahe, Barbara; Busching, Robert; Krause, Christina

2012-01-01

Several longitudinal studies and meta-analytic reviews have demonstrated that exposure to violent media is linked to aggression over time. However, evidence on effective interventions to reduce the use of violent media and promote critical viewing skills is limited. The current study examined the efficacy of an intervention designed to reduce the…

Efficacy, Outcomes, and Empowerment Evaluation of a School District NET Project, Part III: Theoretical Model.

ERIC Educational Resources Information Center

Miller-Whitehead, Marie; Abbott, Gypsy

The efficacy and outcomes of a U.S. Department of Agriculture Nutrition Education Training (NET) project designed to increase awareness of health risk and wellness factors for grade 9 students were studied. This paper comments on results from a survey of 125 ninth graders about the NET curriculum and results from a study of program impact on…

Predicting Collegiate Wind Players' Practice Efficiency, Flow, and Self-Efficacy for Self-Regulation: An Exploratory Study of Relationships Between Teachers' Instruction and Students' Practicing

ERIC Educational Resources Information Center

Miksza, Peter; Tan, Leonard

2015-01-01

The purpose of this study was to determine whether students' practice efficiency, flow during practicing, and self-efficacy for self-regulation varied as a function of their practice tendencies, their tendencies toward self-evaluation, their self-regulatory tendencies to be self-reflective when practicing, tendencies to exhibit grit in their…

Testing the Role of Parental Debt Attitudes, Student Income, Dependency Status, and Financial Knowledge Have in Shaping Financial Self-Efficacy among College Students

ERIC Educational Resources Information Center

Heckman, Stuart J.; Grable, John E.

2011-01-01

This study was designed to evaluate the determinants of personal finance knowledge among college students and to test how this knowledge affects students' perceived self-efficacy beliefs in dealing with personal financial issues. In this study, a test of parental attitudes towards debt, students' income level, and dependency status related to…

Evaluating clinical trial design: systematic review of randomized vehicle-controlled trials for determining efficacy of benzoyl peroxide topical therapy for acne.

PubMed

Lamel, Sonia A; Sivamani, Raja K; Rahvar, Maral; Maibach, Howard I

2015-11-01

Determined efficacies of benzoyl peroxide may be affected by study design, implementation, and vehicle effects. We sought to elucidate areas that may allow improvement in determining accurate treatment efficacies by determining rates of active treatment and vehicle responders in randomized controlled trials assessing the efficacy of topical benzoyl peroxide to treat acne. We conducted a systematic review of randomized vehicle-controlled trials evaluating the efficacy of topical benzoyl peroxide for the treatment of acne. We compared response rates of vehicle treatment arms versus those in benzoyl peroxide arms. Twelve trials met inclusion criteria with 2818 patients receiving benzoyl peroxide monotherapy treatment and 2004 receiving vehicle treatment. The average percent reduction in total number of acne lesions was 44.3 (SD = 9.2) and 27.8 (SD = 21.0) for the active and vehicle treatment groups, respectively. The average reduction in non-inflammatory lesions was 41.5 % (SD = 9.4) in the active treatment group and 27.0 % (SD = 20.9) in the vehicle group. The average percent decrease in inflammatory lesions was 52.1 (SD = 10.4) in the benzoyl peroxide group and 34.7 (SD = 22.7) in the vehicle group. The average percentage of participants achieving success per designated study outcomes was 28.6 (SD = 17.3) and 15.2 (SD = 9.5) in the active treatment and vehicle groups, respectively. Patient responses in randomized controlled trials evaluating topical acne therapies may be affected by clinical trial design, implementation, the biologic effects of vehicles, and natural disease progression. "No treatment" groups may facilitate determination of accurate treatment efficacies.

The intramammary efficacy of first generation cephalosporins against Staphylococcus aureus mastitis in mice.

PubMed

Demon, Dieter; Ludwig, Carolin; Breyne, Koen; Guédé, David; Dörner, Julia-Charlotte; Froyman, Robrecht; Meyer, Evelyne

2012-11-09

Staphylococcus aureus-induced mastitis in cattle causes important financial losses in the dairy industry due to lower yield and bad milk quality. Although S. aureus is susceptible to many antimicrobials in vitro, treatment often fails to cure the infected udder. Hence, comprehensive evaluation of antimicrobials against S. aureus mastitis is desirable to direct treatment strategies. The mouse mastitis model is an elegant tool to evaluate antimicrobials in vivo while circumventing the high costs associated with bovine experiments. An evaluation of the antimicrobial efficacy of the intramammary (imam) applied first generation cephalosporins cefalexin, cefalonium, cefapirin and cefazolin, was performed using the S. aureus mouse mastitis model. In vivo determination of the effective dose 2log(10) (ED(2log10)), ED(4log10), protective dose 50 (PD(50)) and PD(100) in mouse mastitis studies, support that in vitro MIC data of the cephalosporins did not fully concur with the in vivo clinical outcome. Cefazolin was shown to be the most efficacious first generation cephalosporin to treat S. aureus mastitis whereas the MIC data indicate that cefalonium and cefapirin were more active in vitro. Changing the excipient for imam application from mineral oil to miglyol 812 further improved the antimicrobial efficacy of cefazolin, confirming that the excipient can influence the in vivo efficacy. Additionally, statistical analysis of the variation of S. aureus-infected, excipient-treated mice from fourteen studies emphasizes the strength of the mouse mastitis model as a fast, cost-effective and highly reproducible screening tool to assess the efficacy of antimicrobial compounds against intramammary S. aureus infection. Copyright © 2012 Elsevier B.V. All rights reserved.

Best methods for evaluating educational impact: a comparison of the efficacy of commonly used measures of library instruction

PubMed Central

Schilling, Katherine; Applegate, Rachel

2012-01-01

Objectives and Background: Libraries are increasingly called upon to demonstrate student learning outcomes and the tangible benefits of library educational programs. This study reviewed and compared the efficacy of traditionally used measures for assessing library instruction, examining the benefits and drawbacks of assessment measures and exploring the extent to which knowledge, attitudes, and behaviors actually paralleled demonstrated skill levels. Methods: An overview of recent literature on the evaluation of information literacy education addressed these questions: (1) What evaluation measures are commonly used for evaluating library instruction? (2) What are the pros and cons of popular evaluation measures? (3) What are the relationships between measures of skills versus measures of attitudes and behavior? Research outcomes were used to identify relationships between measures of attitudes, behaviors, and skills, which are typically gathered via attitudinal surveys, written skills tests, or graded exercises. Results and Conclusions: Results provide useful information about the efficacy of instructional evaluation methods, including showing significant disparities between attitudes, skills, and information usage behaviors. This information can be used by librarians to implement the most appropriate evaluation methods for measuring important variables that accurately demonstrate students' attitudes, behaviors, or skills. PMID:23133325

Best methods for evaluating educational impact: a comparison of the efficacy of commonly used measures of library instruction.

PubMed

Schilling, Katherine; Applegate, Rachel

2012-10-01

Libraries are increasingly called upon to demonstrate student learning outcomes and the tangible benefits of library educational programs. This study reviewed and compared the efficacy of traditionally used measures for assessing library instruction, examining the benefits and drawbacks of assessment measures and exploring the extent to which knowledge, attitudes, and behaviors actually paralleled demonstrated skill levels. An overview of recent literature on the evaluation of information literacy education addressed these questions: (1) What evaluation measures are commonly used for evaluating library instruction? (2) What are the pros and cons of popular evaluation measures? (3) What are the relationships between measures of skills versus measures of attitudes and behavior? Research outcomes were used to identify relationships between measures of attitudes, behaviors, and skills, which are typically gathered via attitudinal surveys, written skills tests, or graded exercises. Results provide useful information about the efficacy of instructional evaluation methods, including showing significant disparities between attitudes, skills, and information usage behaviors. This information can be used by librarians to implement the most appropriate evaluation methods for measuring important variables that accurately demonstrate students' attitudes, behaviors, or skills.

Safety and efficacy of fesoterodine fumarate in patients with overactive bladder: results of a post-marketing surveillance study in Korea.

PubMed

Kim, Tae Heon; Lee, Sang Eun; Lee, Hahn-Ey; Lee, Kyu-Sung

2016-08-01

The aim of this study was to evaluate the safety and efficacy of fesoterodine fumarate (fesoterodine; Toviaz ) in Korean patients with overactive bladder (OAB) in routine clinical practice. This was an open-label, non-interventional, prospective, post-marketing surveillance study submitted to the Korean Ministry of Food and Drug Safety. A total of 3109 patients aged ≥18 years with OAB symptoms were prescribed flexible doses of fesoterodine at the investigator's discretion. Safety was assessed based upon the reporting of adverse events (AEs). Efficacy was evaluated on the basis of patient self-assessment using a bladder diary as well as on the basis of investigator assessment in terms of overall clinical efficacy. A final analysis was performed on 3107 (99.9%) and 2978 (95.8%) patients for safety and efficacy analysis, respectively. The mean treatment duration of fesoterodine was 83.2 days. The incidence of AEs was 8.5% (265/3107). Common AEs that accounted for more than 1.0% of the total AE incidence included dry mouth (5.4%, 168/3107), constipation (1.5%, 48/3107) and micturition disorder (1.1%, 35/3107). Mean episodes of urinary frequency, urgency, and urgency urinary incontinence (UUI) per 24 hours decreased by 4.0, 2.4, and 0.8, respectively (all p < 0.001). At the final follow-up visit, the investigators found improvement in clinical efficacy for the majority of patients (90.1%, 2684/2978). Limitations of this study include the observational study design and the relatively short treatment duration. These results suggest that fesoterodine is a well tolerated and effective treatment for Korean patients with OAB in routine clinical practice.

Validation of an instrument for mathematics enhancement teaching efficacy of Pacific Northwest agricultural educators

NASA Astrophysics Data System (ADS)

Jansen, Daniel J.

Teacher efficacy continues to be an important area of study in educational research. This study tested an instrument designed to assess the perceived efficacy of agricultural education teachers when engaged in lessons involving mathematics instruction. The study population of Oregon and Washington agricultural educators utilized in the validation of the instrument revealed important demographic findings and specific results related to teacher efficacy for the study population. An instrument was developed from the assimilation of three scales previously used and validated in efficacy research. Participants' mathematics teaching efficacy was assessed using a portion of the Mathematics Teaching Efficacy Beliefs Instrument (MTEBI), and personal mathematics efficacy was evaluated by the mathematics self-belief instrument which was derived from the Betz and Hackett's Mathematics Self-Efficacy Scale. The final scale, the Teachers' Sense of Efficacy Scale (TSES) created by Tschannen-Moran and Woolfolk Hoy, examined perceived personal teaching efficacy. Structural equation modeling was used as the statistical analyses tool to validate the instrument and examine correlations between efficacy constructs used to determine potential professional development needs of the survey population. As part of the data required for validation of the Mathematics Enhancement Teaching Efficacy instrument, demographic information defining the population of Oregon and Washington agricultural educators was obtained and reported. A hypothetical model derived from teacher efficacy literature was found to be an acceptable model to verify construct validity and determine strength of correlations between the scales that defined the instrument. The instrument produced an alpha coefficient of .905 for reliability. Both exploratory and confirmatory factor analyses were used to verify construct and discriminate validity. Specifics results related to the survey population of agricultural educators concluded that personal mathematics efficacy has a stronger correlation with mathematics teaching efficacy than personal teaching efficacy of teachers for this population. The implications of such findings suggest that professional development and pre-service preparation should be more focused on mathematics content knowledge rather than pedagogical knowledge when the objective is to enhance mathematics in interdisciplinary lessons.

A Multi-Stage Longitudinal Comparative Design Stage II Evaluation of the Changing Lives Program: The Life Course Interview (RDA-LCI)

ERIC Educational Resources Information Center

Arango, Lisa Lewis; Kurtines, William M.; Montgomery, Marilyn J.; Ritchie, Rachel

2008-01-01

The study reported in this article, a Multi-Stage Longitudinal Comparative Design Stage II evaluation conducted as a planned preliminary efficacy evaluation (psychometric evaluation of measures, short-term controlled outcome studies, etc.) of the Changing Lives Program (CLP), provided evidence for the reliability and validity of the qualitative…

The development and psychometrical evaluation of a set of instruments to evaluate the effectiveness of diabetes patient education.

PubMed

Duprez, Veerle; De Pover, Marleen; De Spiegelaere, Marc; Beeckman, Dimitri

2014-02-01

To develop a set of psychometrically sound instruments to assess knowledge, self-management and self-efficacy of diabetic patients. Furthermore, a survey to evaluate the satisfaction about diabetes education for patients was developed and tested. Treatment and secondary prevention of diabetes require a complex combination of care components. Patients' education has been accepted to improve diabetes knowledge, self-management and self-efficacy. Psychometrically sound instruments are needed to measure these patient-centred outcomes. Psychometric instrument validation. The first phase included a systematic literature review to develop the instruments. Content validity was evaluated using a two-round Delphi procedure involving diabetes experts. The content validity of the instruments was excellent. In a second phase, a convenience sample of 188 diabetic patients in two hospitals in one specific care region in Belgium participated in the psychometric evaluation. The criterion-related validity and internal consistency reliability were evaluated. The study produced a 21-item knowledge instrument, reflecting knowledge about 'glycemic control' and 'medico-social management aspects'. The self-management instrument included 32 statements, reflecting 'treatment and compliance' and 'general lifestyle'. The self-efficacy instrument included 30 items, reflecting 'nutrition', 'treatment' and 'regimen'. The patient satisfaction survey included 36 items, reflecting satisfaction about the relationship among the diabetes specialist, the diabetes educator, podiatrist and dietician. An instrument set with sound psychometric characteristics was developed to assess knowledge, self-management and self-efficacy of diabetic patients. Future studies should focus on the association between the instrument outcomes and clinical patient outcomes. The current instrument can support the design of educational interventions and training programmes and reduce inconsistencies in the information that patients receive. Furthermore, the instruments can be used for benchmarking the quality of diabetic patient education. © 2013 Blackwell Publishing Ltd.

Non-tuberculous mycobacteria have diverse effects on BCG efficacy against Mycobacterium tuberculosis.

PubMed

Poyntz, Hazel C; Stylianou, Elena; Griffiths, Kristin L; Marsay, Leanne; Checkley, Anna M; McShane, Helen

2014-05-01

The efficacy of Bacillus Calmette-Guerin (BCG) vaccination in protection against pulmonary tuberculosis (TB) is highly variable between populations. One possible explanation for this variability is increased exposure of certain populations to non-tuberculous mycobacteria (NTM). This study used a murine model to determine the effect that exposure to NTM after BCG vaccination had on the efficacy of BCG against aerosol Mycobacterium tuberculosis challenge. The effects of administering live Mycobacterium avium (MA) by an oral route and killed MA by a systemic route on BCG-induced protection were evaluated. CD4+ and CD8+ T cell responses were profiled to define the immunological mechanisms underlying any effect on BCG efficacy. BCG efficacy was enhanced by exposure to killed MA administered by a systemic route; T helper 1 and T helper 17 responses were associated with increased protection. BCG efficacy was reduced by exposure to live MA administered by the oral route; T helper 2 cells were associated with reduced protection. These findings demonstrate that exposure to NTM can induce opposite effects on BCG efficacy depending on route of exposure and viability of NTM. A reproducible model of NTM exposure would be valuable in the evaluation of novel TB vaccine candidates. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Therapeutic Efficacy of a Combination Therapy of Topical 17α-Estradiol and Topical Minoxidil on Female Pattern Hair Loss: A Noncomparative, Retrospective Evaluation

PubMed Central

Choe, Sung Jay; Lee, Solam; Choi, Jaewoong

2017-01-01

Background A variety of agents have been used to treat female pattern hair loss (FPHL), including topical minoxidil, topical 17α-estradiol, oral anti-androgen agents, and mineral supplements. Compared with these single agent regimens, combination therapies could be a better therapeutic option in expectation of superior treatment outcome. Objective This study was designed to determine the efficacy of a combination therapy consisting of topical 0.025% 17α-estradiol and 3% minoxidil in Korean patients with FPHL. Methods Therapeutic efficacy was evaluated in 34 women who applied topical 0.025% 17α-estradiol and 3% minoxidil once daily for more than 6 months. Phototrichogram analysis was performed before and after therapy. The efficacy was evaluated with respect to total hair count, hair caliber (as assessed by phototrichogram analysis), and photographic assessment. Results Total hair count and hair caliber both increased from baseline to 6 months in patients treated with the combination therapy of topical 0.025% 17α-estradiol and 3% minoxidil (p<0.001). Photographic assessment also revealed significant disease improvement, thus supporting the therapeutic efficacy. Conclusion A combination therapy consisting of topical 0.025% 17α-estradiol and 3% minoxidil can be tried as an effective treatment for FPHL. PMID:28566902

Therapeutic Efficacy of a Combination Therapy of Topical 17α-Estradiol and Topical Minoxidil on Female Pattern Hair Loss: A Noncomparative, Retrospective Evaluation.

PubMed

Choe, Sung Jay; Lee, Solam; Choi, Jaewoong; Lee, Won-Soo

2017-06-01

A variety of agents have been used to treat female pattern hair loss (FPHL), including topical minoxidil, topical 17α-estradiol, oral anti-androgen agents, and mineral supplements. Compared with these single agent regimens, combination therapies could be a better therapeutic option in expectation of superior treatment outcome. This study was designed to determine the efficacy of a combination therapy consisting of topical 0.025% 17α-estradiol and 3% minoxidil in Korean patients with FPHL. Therapeutic efficacy was evaluated in 34 women who applied topical 0.025% 17α-estradiol and 3% minoxidil once daily for more than 6 months. Phototrichogram analysis was performed before and after therapy. The efficacy was evaluated with respect to total hair count, hair caliber (as assessed by phototrichogram analysis), and photographic assessment. Total hair count and hair caliber both increased from baseline to 6 months in patients treated with the combination therapy of topical 0.025% 17α-estradiol and 3% minoxidil ( p <0.001). Photographic assessment also revealed significant disease improvement, thus supporting the therapeutic efficacy. A combination therapy consisting of topical 0.025% 17α-estradiol and 3% minoxidil can be tried as an effective treatment for FPHL.

Transdermal scopolamine in the prevention of motion sickness - Evaluation of the time course of efficacy

NASA Technical Reports Server (NTRS)

Homick, J. L.; Reschke, M. F.; Degioanni, J.; Cintron-Trevino, N. M.; Kohl, R. L.

1983-01-01

This study evaluated the time course of efficacy of transdermal scopolamine in the prevention of motion sickness induced by exposure to coriolis stimulation in a rotating chair. We measured levels of efficacy, quantified side effects and symptoms, and determined inter- and intra-subject variability following use of transdermal scopolamine. The response to transdermal scopolamine was highly variable, although overall we recorded a 40 percent improvement in test scores 16-72 h after application of the transdermal system. This variability could not be explained solely by the levels of scopolamine present in the blood. The improvement was not due to the artifactual repression by scopolamine of selected symptoms of motion sickness. An unexpectedly high incidence of side effects was reported. It was concluded that the therapeutic use of transdermal scopolamine be evaluated individually and that individuals be cautioned that subsequent usage may not always be effective.

In vitro evaluation of the disinfection efficacy on Eimeria tenella unsporulated oocysts isolated from broilers.

PubMed

Guimarães, José S; Bogado, Alexey L Gomel; da Cunha, Thiago Cezar B; Garcia, João Luis

2007-01-01

The objective of this study was to evaluate in vitro the action of eight chemical principles by disinfection efficacy (DE) of Eimeria tenella oocysts. Disinfection efficacy was evaluated by either destruction or sporulation inhibition of the oocysts. Eight treatments were performed: T1 (Glutaraldehyde 42.5 g + Benzalkonium Chloride 7.5 g); T2 (Benzalkonium chloride + quaternary ammonium salt); T3 (formol 37% + Sodium Dodecylbenzene Sulfonate 12%); T4 (sodium hypochlorite 2%); T5 (Orthodichlorobenzene 60% + Xylene 30%); T6 (Polyoctyl polyamino ethyl glycine + Polyoxyethylene alkylphenol ether + Sodium Chloride); T7 (Chloramine T) and finally T8 (free iodine 2.25% + Phosphoric acid 15 g). The control test was carried out with distilled water (T9). The best DE were observed, respectively, in T3 (79.49%), T5 (75.60%) and T4 (65.56%) treatments.

Evaluation of an interaction-skills training for reducing the burden of family caregivers of patients with severe mental illness: a pre-posttest design.

PubMed

Gharavi, Yasmin; Stringer, Barbara; Hoogendoorn, Adriaan; Boogaarts, Jan; Van Raaij, Bas; Van Meijel, Berno

2018-03-27

Family members who care for patients with severe mental illness experience emotional distress and report a higher incidence of mental illness than those in the general population. They report feeling inadequately prepared to provide the necessary practical and emotional support for these patients. The MAT training, an Interaction-Skills Training program (IST) for caregivers, was developed to meet those needs. This study used a single-arm pretest-posttest design to examine the impact of the training on caregivers' sense of competence (self-efficacy) and burden. One hundred family caregivers recruited from three mental health institutions participated in the training. Burden was assessed using the Involvement Evaluation Questionnaire, and self-efficacy using the Self-Efficacy Questionnaire. Analysis of variance with repeated measures was used to investigate whether participation in the training changed the level of family caregivers' burden and self-efficacy. Pearson's correlation was used to examine the relationships between self-efficacy and burden. Our results indicate that, after the training, self-efficacy increased significantly over time (p < 0.001) and that burden decreased significantly (p < 0.001). However, the results could not demonstrate the expected association between an increase of self-efficacy and decrease of burden. Caregivers expressed high appreciation for the training. After following the IST program, family caregivers of patients with severe mental illness experienced a greater sense of competence and a significant decrease in burden. The training was greatly appreciated and satisfied caregivers' need to acquire the skills required in complex caregiving situations. This study was retrospectively registered (14/01/2018) in the ISRCTN registry with study ID ISRCTN44495131 .

Evaluation of Burnout Levels in Teachers Regarding Socio-Demographic Variables, Job Satisfaction and General Self-Efficacy

ERIC Educational Resources Information Center

Capri, Burhan; Guler, Mustafa

2018-01-01

Purpose: This study aims to examine the occupational burnout levels of teachers working in special education and rehabilitation centers affiliated with the Ministry of National Education regarding socio-demographic variables, job satisfaction, and general self-efficacy levels. Research Methods: The descriptive method and relational scanning model…

Examining the Preliminary Efficacy of a Dating Violence Prevention Program for Hispanic Adolescents

ERIC Educational Resources Information Center

Gonzalez-Guarda, Rosa Maria; Guerra, Jessica E.; Cummings, Amanda A.; Pino, Karen; Becerra, Maria M.

2015-01-01

The purpose of this study is to evaluate the preliminary efficacy of a dating violence (DV) prevention program for Cuban American adolescents ("JOVEN"/YOUTH: "Juntos Opuestos a la Violence Entre Novios"/Together Against Dating Violence). A randomized-controlled experimental design with a delayed condition was used to evaluate…

Assessing the Efficacy of a School Health Education Advocacy Lesson with College Students

ERIC Educational Resources Information Center

Wallen, Michele; Chaney, Beth H.; Birch, David A.

2012-01-01

Purpose: The researchers evaluated the efficacy of an advocacy lesson to assess change in intentions to advocate for school health education. This study also measured changes in participants' understanding the importance of school health education and perceived effectiveness in applying advocacy skills. Methods: A convenience sample of college…

Can Process Portfolios Affect Students' Writing Self-Efficacy?

ERIC Educational Resources Information Center

Nicolaidou, Iolie

2012-01-01

Can process portfolios that support students in goal setting, reflection, self-evaluation and feedback have a positive impact on students' writing self-efficacy? This article presents the findings of a yearlong study conducted in three 4th grade elementary classes in Cyprus where paper-based and web-based portfolios were implemented to help…

Efficacy of management tools for control of Pythium root rot of Douglas fir seedlings, 2010

USDA-ARS?s Scientific Manuscript database

This study investigated the efficacy of management tools for control of Pythium root rot of Douglas fir seedlings. This effort was conducted as part of the IR-4 Ornamental Horticulture program to evaluate fungicides and biopesticides for management of root, crown and stem rot of ornamental plants ca...

High pressure treatment of human norovirus virus-like particles: factors affecting destruction efficacy

USDA-ARS?s Scientific Manuscript database

Human norovirus (NoV) accounts for more than 90% of nonbacterial gastroenteritis. To date, the efficacy of human NoV inactivation interventions cannot be accurately evaluated because the virus is nonculturable. In this study, we aimed to estimate inactivation of human NoV by high pressure processing...

Efficacy of reducing sugar and phenol-sulfuric acid assays for analysis of soluble carbohydrates in feedstuffs

USDA-ARS?s Scientific Manuscript database

Reducing sugar (RSA) and phenol–sulfuric acid (PSA) assays are commonly used to analyze water-soluble carbohydrates. However, questions have arisen as to their accuracy for measurement of feedstuffs with diverse carbohydrate profiles. This study evaluated the efficacy of RSA and PSA as they would co...

Efficacy of a live attenuated Edwardsiella ictaluri oral vaccine in channel and hybrid catfish

USDA-ARS?s Scientific Manuscript database

This study evaluated the efficacy of an oral live-attenuated Edwardsiella ictaluri vaccine against enteric septicemia of catfish (ESC) in channel and hybrid catfish. The vaccine was delivered orally by feeding fish a diet coated with an attenuated E. ictaluri isolate at four doses to deliver betwee...

Comparison of the efficacy of free residual chlorine and monochloramine against biofilms in model and full scale cooling towers.

PubMed

Türetgen, Irfan

2004-04-01

The presence of microbial cells on surfaces results in the formation of biofilms, which may also give rise to microbiologically influenced corrosion. Biofilms accumulate on all submerged industrial and environmental surfaces. The efficacy of disinfectants is usually evaluated using planktonic cultures, which often leads to an underestimate of the concentration required to control a biofilm. The aim of this study was to investigate the efficacy of monochloramine on biofilms developed in a cooling tower. The disinfectants selected for the study were commercial formulations recommended for controlling microbial growth in cooling towers. A cooling tower and a laboratory model recirculating water system were used as biofilm reactors. Although previous studies have evaluated the efficacy of free chlorine and monochloramine for controlling biofilm growth, there is a lack of published data concerning the use monochloramine in cooling towers. Stainless steel coupons were inserted in each tower basin for a period of 30 d before removal. Monochloramine and free chlorine were tested under identical conditions on mixed biofilms which had been allowed to grow on coupons. Monochloramine was found to be significantly more effective than free chlorine against cooling tower biofilms.

[Efficacy of commercially available vaccines against HPV infection in women: a systematic review and meta-analysis].

PubMed

Araujo, Silvia Cristina Fonseca de; Caetano, Rosângela; Braga, Jose Ueleres; Costa e Silva, Frances Valéria

2013-11-01

Persistent HPV infection is a necessary condition for the occurrence of cervical cancer. Prophylactic HPV vaccines have been developed to reduce the incidence of cervical cancer. Two vaccines are commercially available: bivalent (types 16, 18) and quadrivalent (6, 11, 16 and 18). This study aimed to perform a systematic review and metaanalysis of the HPV vaccines' efficacy in women, focusing its performance stratified by clinical outcomes. Randomized controlled trials (RCT) published between 2000 and 2009 were identified from searches of MEDLINE, LILACS and Cochrane Library, and evaluated by two independent reviewers. Six RCT were selected. The vaccines reduced the risk of precursor lesions of cervical cancer, presenting efficacy of 97% (95%CI: 90-99) for CIN 2 and 96% (95%CI: 89-99) for CIN 3, in the per protocol analysis. The efficacies in the analysis by intention to treat were smaller: 63% (95%CI: 52-71) and 42% (95%CI: 26-55), respectively. In order to evaluate its effectiveness on the incidence and mortality rates for cervical cancer, longer-term studies will be needed.

Efficacy of Topical Therapy with Newly Developed Terbinafine and Econazole Formulations in the Treatment of Dermatophytosis in Cats.

PubMed

Ivaskiene, M; Matusevicius, A P; Grigonis, A; Zamokas, G; Babickaite, L

2016-09-01

In the field of veterinary dermatology dermatophytosis is one of the most frequently occurring infectious diseases, therefore its treatment should be effective, convenient, safe and inexpensive. The aim of this study was to evaluate the efficacy of newly developed topical formulations in the treatment of cats with dermatophytosis. Evaluation of clinical efficacy and safety of terbinafine and econazole formulations administered topically twice a day was performed in 40 cats. Cats, suffering from the most widely spread Microsporum canis-induced dermatophytosis and treated with terbinafine hydrochloride 1% cream, recovered within 20.3±0.88 days; whereas when treated with econazole nitrate 1% cream, they recovered within 28.4±1.14 days. A positive therapeutic effect was yielded by combined treatment with local application of creams and whole coat spray with enilconazole 0.2% emulsion "Imaverol". Most cats treated with econazole cream revealed redness and irritation of the skin at the site of application. This study demonstrates that terbinafine tended to have superior clinical efficacy (p<0.001) in the treatment of dermatophytosis in cats compared to the azole tested.

Characterization, sensorial evaluation and moisturizing efficacy of nanolipidgel formulations.

PubMed

Estanqueiro, M; Conceição, J; Amaral, M H; Sousa Lobo, J M

2014-04-01

Nanostructured lipid carriers (NLC) have been widely studied for cosmetic and dermatological applications due to their favourable properties that include the formation of an occlusive film on the skin surface that reduces the transepidermal water loss (TEWL) and increase in water content in the skin which improves the appearance on healthy human skin and reduces symptoms of some skin disorders like eczema. The main objective of this study was the development of semisolid formulations based NLC with argan oil or jojoba oil as liquid lipids, by addition of Carbopol®934 or Carbopol®980 as gelling agents, followed by comparison between instrumental analysis and sensorial evaluation and in vivo efficacy evaluation. Nanostructured lipid carriers dispersions were produced by the ultrasound technique, and to obtain a semisolid formulation, gelling agents were dispersed in the aqueous dispersion. Particle size, polydispersity index and zeta potential were determined. Instrumental characterization was performed by rheological and textural analysis; the sensorial evaluation was also performed. Finally, skin hydration and TEWL were studied by capacitance and evaporimetry evaluation, respectively. Particles showed a nanometric size in all the analysed formulations. All the gels present pseudoplastic behaviour. There is a correspondence between the properties firmness and adhesiveness as determined by textural analysis and the sensory evaluation. The formulations that showed a greater increase in skin hydration also presented appropriate technological and sensorial attributes for skin application. Nanolipidgel formulations with the addition of humectants are promising systems for cosmetic application with good sensory and instrumental attributes and moisturizing efficacy.

Efficacy of emamectin benzoate against sea lice infestations of Atlantic salmon, Salmo salar L.: evaluation in the absence of an untreated contemporary control.

PubMed

Gustafson, L; Ellis, S; Robinson, T; Marenghi, F; Endris, R

2006-10-01

The efficacy of emamectin benzoate (SLICE) against sea lice infestations of Atlantic salmon, Salmo salar L., is typically assessed using untreated fish, or fish treated with alternative therapeutants, as controls. The State of Maine, USA, is currently under active management for the OIE-notifiable pathogen, infectious salmon anaemia virus (ISAV); consequently, neither control group is feasible in this region. Untreated salmon risk extensive damage from the ectoparasites, and threaten to increase vector-borne exposure or susceptibility of farms to ISAV; and the only treatment presently available in Maine is SLICE. However, because sea lice infestations are unlikely to resolve spontaneously, and response to treatment occurs within weeks, use of a pretreatment baseline is a reasonable alternative for confirmatory studies. We evaluated SLICE efficacy on Atlantic salmon farms in Cobscook Bay 2002-2005, in the absence of untreated controls, using pretreatment lice loads as a reference for calculation. Maximum efficacy ranged from 68% to 100% reduction from initial levels. Time-to-maximum efficacy ranged from 1 to 8 weeks after treatment initiation. Efficacy duration, measured between first reduction and first progressive rise in counts, ranged from 4 to 16 weeks.

Efficacy and Safety of Atomoxetine in the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder

PubMed Central

Kohn, Michael R.; Tsang, Tracey W.; Clarke, Simon D.

2012-01-01

Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD). Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication. PMID:23641171

Synthesis and evaluation of dual antiplatelet activity of bispidine derivatives of N-substituted pyroglutamic acids.

PubMed

Misra, Ankita; Anil Kumar, K S; Jain, Manish; Bajaj, Kirti; Shandilya, Shyamali; Srivastava, Smriti; Shukla, Pankaj; Barthwal, Manoj K; Dikshit, Madhu; Dikshit, Dinesh K

2016-03-03

N-aralkylpyroglutamides of substituted bispidine were prepared and evaluated for their ability to inhibit collagen induced platelet aggregation, both in vivo and in vitro. Some compounds showed high anti-platelet efficacy (in vitro) of which six inhibited both collagen as well as U46619 induced platelet aggregation with concentration dependent anti-platelet efficacy through dual mechanism. In particular, the compound 4j offered significant protection against collagen epinephrine induced pulmonary thromboembolism as well as ferric chloride induced arterial thrombosis, without affecting bleeding tendency in mice. Therefore, the present study suggests that the compound 4j displays a remarkable antithrombotic efficacy much better than aspirin and clopidogrel. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Pilot of the Chronic Disease Self-Management Program (CDSMP) for Adolescents and Young Adults with Sickle Cell Disease

PubMed Central

Crosby, Lori E.; Joffe, Naomi E.; Peugh, James; Ware, Russell E.; Britto, Maria T.

2016-01-01

Purpose This study evaluated the feasibility of a group self-management intervention, the well-established Stanford Chronic Disease Self-Management Program (CDSMP), for adolescents and young adults (AYA) with sickle cell disease (SCD). Methods A total of 22 AYA participants with SCD, ages 16 to 24 years, completed self-efficacy and quality of life (HRQOL) measures before the CDSMP, after, and 3 and 6 months later. Results This AYA cohort showed significant improvements in self-efficacy (primary outcome) after the intervention. Analyses of follow-up data revealed a medium effect of the CDSMP on patient activation 3 months post although this was not sustained. Participants were highly satisfied, but only 64% completed the program. Conclusions This study demonstrates that the CDSMP is acceptable, and has the ability to improve self-efficacy. Additional research is needed to determine feasibility and evaluate health outcomes for AYA with SCD. PMID:27793727

Systematic review of studies generating individual participant data on the efficacy of drugs for treating soil-transmitted helminthiases and the case for data-sharing.

PubMed

Halder, Julia B; Benton, Joanne; Julé, Amélie M; Guérin, Phillipe J; Olliaro, Piero L; Basáñez, María-Gloria; Walker, Martin

2017-10-01

Preventive chemotherapy and transmission control (PCT) by mass drug administration is the cornerstone of the World Health Organization (WHO)'s policy to control soil-transmitted helminthiases (STHs) caused by Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and hookworm species (Necator americanus and Ancylostama duodenale) which affect over 1 billion people globally. Despite consensus that drug efficacies should be monitored for signs of decline that could jeopardise the effectiveness of PCT, systematic monitoring and evaluation is seldom implemented. Drug trials mostly report aggregate efficacies in groups of participants, but heterogeneities in design complicate classical meta-analyses of these data. Individual participant data (IPD) permit more detailed analysis of drug efficacies, offering increased sensitivity to identify atypical responses potentially caused by emerging drug resistance. We performed a systematic literature review to identify studies concluding after 2000 that collected IPD suitable for estimating drug efficacy against STH. We included studies that administered a variety of anthelmintics with follow ups less than 60 days after treatment. We estimated the number of IPD and extracted cohort- and study-level meta-data. We estimate that there exist individual data on approximately 35,000 participants from 129 studies conducted in 39 countries, including 34 out of 103 countries where PCT is recommended. We find significant heterogeneity in diagnostic methods, times of outcome assessment, and the reported measure of efficacy. We also quantify cohorts comprising pre-school age children, pregnant women, and co-infected participants, including with HIV. We argue that establishing a global IPD repository would improve the capacity to monitor and evaluate the efficacy of anthelmintic drugs, respond to changes and safeguard the ongoing effectiveness of PCT. Establishing a fair, transparent data governance policy will be key for the engagement of the global STH community.

Systematic review of studies generating individual participant data on the efficacy of drugs for treating soil-transmitted helminthiases and the case for data-sharing

PubMed Central

Halder, Julia B.; Benton, Joanne; Julé, Amélie M.; Guérin, Phillipe J.; Olliaro, Piero L.; Basáñez, María-Gloria; Walker, Martin

2017-01-01

Background Preventive chemotherapy and transmission control (PCT) by mass drug administration is the cornerstone of the World Health Organization (WHO)’s policy to control soil-transmitted helminthiases (STHs) caused by Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and hookworm species (Necator americanus and Ancylostama duodenale) which affect over 1 billion people globally. Despite consensus that drug efficacies should be monitored for signs of decline that could jeopardise the effectiveness of PCT, systematic monitoring and evaluation is seldom implemented. Drug trials mostly report aggregate efficacies in groups of participants, but heterogeneities in design complicate classical meta-analyses of these data. Individual participant data (IPD) permit more detailed analysis of drug efficacies, offering increased sensitivity to identify atypical responses potentially caused by emerging drug resistance. Methodology We performed a systematic literature review to identify studies concluding after 2000 that collected IPD suitable for estimating drug efficacy against STH. We included studies that administered a variety of anthelmintics with follow ups less than 60 days after treatment. We estimated the number of IPD and extracted cohort- and study-level meta-data. Principal findings We estimate that there exist individual data on approximately 35,000 participants from 129 studies conducted in 39 countries, including 34 out of 103 countries where PCT is recommended. We find significant heterogeneity in diagnostic methods, times of outcome assessment, and the reported measure of efficacy. We also quantify cohorts comprising pre-school age children, pregnant women, and co-infected participants, including with HIV. Conclusions We argue that establishing a global IPD repository would improve the capacity to monitor and evaluate the efficacy of anthelmintic drugs, respond to changes and safeguard the ongoing effectiveness of PCT. Establishing a fair, transparent data governance policy will be key for the engagement of the global STH community. PMID:29088274

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 Central

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

Background 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. Methods Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125mg 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. Results 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). Conclusions 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. Trial Registration ClinicalTrials.gov NCT02486354 PMID:26599904

Presenting efficacy information in direct-to-consumer prescription drug advertisements.

PubMed

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

2014-05-01

We evaluated whether presenting prescription drug efficacy information in direct-to-consumer (DTC) advertising helps individuals accurately report a drug's benefits and, if so, which numerical format is most helpful. We conducted a randomized, controlled study of individuals diagnosed with high cholesterol (n=2807) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats. We measured drug efficacy recall, drug perceptions and attitudes, behavioral intentions, and drug risk recall. Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information. Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats. Adding efficacy information to DTC ads-both in print and on television-may potentially increase an individual's knowledge of a drug's efficacy, which may improve patient-provider communication and promote more informed decisions. Providing quantitative efficacy information in a combination of formats (e.g., absolute frequency and percent) may help patients remember information and make decisions about prescription drugs. Published by Elsevier Ireland Ltd.

Antimicrobial efficacy of oral topical agents on microorganisms associated with radiated head and neck cancer patients: an in vitro study.

PubMed

Bidra, Avinash S; Tarrand, Jeffery J; Roberts, Dianna B; Rolston, Kenneth V; Chambers, Mark S

2011-04-01

A variety of oral topical agents have been used for prevention and management of radiotherapy-induced adverse effects. The antimicrobial nature of some of the commonly used agents is unknown. The purpose of this study was to evaluate antimicrobial efficacies of various oral topical agents on common microorganisms associated with radiated head and neck cancer patients. Seven commonly used topical oral agents-0.12% chlorhexidine with alcohol, 0.12% chlorhexidine without alcohol, baking soda-salt rinse, 0.4% stannous fluoride gel, 0.63% stannous fluoride rinse, calcium phosphate mouthrinse, and acemannan hydrogel (aloe vera) rinse-were evaluated in vitro for their antimicrobial efficacies against four common microorganisms. A combination of baking soda-salt rinse and 0.4% stannous fluoride gel was evaluated as the eighth agent. The microorganisms used were Staphylococcus aureus, group B Streptococcus, Escherichia coli, and Candida albicans. An ELISA reader was used to measure the turbidity of microbial culture wells and optical density (OD) values for each of the 960 wells recorded. Mean OD values were rank ordered based on their turbidity. One-way ANOVA with Tukey HSD post hoc analysis was used to study differences in OD values (P < .05). Mean OD values classified for topical agents from lowest to highest were chlorhexidine with alcohol, chlorhexidine without alcohol, baking soda- salt, calcium phosphate rinse, and the combination of baking soda-salt and stannous fluoride gel. Mean OD values classified for microorganisms from lowest to highest were Escherichia coli, Staphylococcus aureus, group B Streptococcus, and Candida albicans. A significant difference among the antimicrobial efficacies of topical agents was evident for each of four microorganisms (P < .05). There was also a significant difference among the antimicrobial efficacies of the same topical agent on the four microorganisms tested (P < .05).

Open-Label Single-Sequence Crossover Study Evaluating Pharmacokinetics, Efficacy, and Safety of Once-Daily Dosing of Nitisinone in Patients with Hereditary Tyrosinemia Type 1.

PubMed

Guffon, Nathalie; Bröijersén, Anders; Palmgren, Ingrid; Rudebeck, Mattias; Olsson, Birgitta

2018-01-01

Although nitisinone is successfully used to treat hereditary tyrosinemia type 1 (HT-1) with the recommended twice-daily dosing, data describing a long half-life motivate less frequent dosing. Therefore, in agreement with the Pharmacovigilance Risk Assessment Committee at the European Medicines Agency, this study was performed to investigate the switch to once-daily dosing. This open-label, non-randomized, single-sequence crossover study evaluated the pharmacokinetics, efficacy, and safety of once-daily compared to twice-daily dosing of nitisinone in patients with HT-1 (NCT02323529). Well-controlled patients of <2, 2 to <12, 12 to <18, and ≥18 years of age who were on twice-daily dosing were eligible for participation. Nitisinone and succinylacetone levels were determined from dry blood spots by tandem mass spectrometry. The primary endpoint was C min of nitisinone after ≥4 weeks of treatment on each dosing regimen. Secondary objectives were evaluation of efficacy and safety during each dosing regimen. In total, 19 patients were enrolled and 17 included in the per-protocol analysis set. The mean (SD) nitisinone C min decreased by 23%, from 26.4 (10.2) to 21.2 (9.9) μmol/L in dry blood spot samples (not equivalent to plasma concentrations), when patients switched from twice- to once-daily dosing. There was no apparent age- or bodyweight-related trend in the degree of C min decrease. No patient had quantifiable succinylacetone levels during the once-daily treatment period, indicating efficacious treatment. All adverse events were mild or moderate and judged unrelated to nitisinone. The switch to once-daily treatment with nitisinone appeared efficacious and safe in the treatment of patients with HT-1.

Efficacy and safety of acupuncture therapy for nerve deafness: a meta-analysis of randomized controlled trials.

PubMed

Jiang, Yuebo; Shi, Xian; Tang, Yan

2015-01-01

Acupuncture is one of the important parts of therapeutic methods in traditional Chinese medicine, and has been widely used for the treatment of nerve deafness in recent years. The current study was to evaluate the efficacy and safety of acupuncture therapy for nerve deafness compared with conventional medicine therapy. PubMed, the Chinese National Knowledge Infrastructure Database, the Chinese Science and Technology Periodical Database, the Chinese Biomedical Database, the Wanfang Database were searched for articles published to identify randomized controlled trials evaluating efficacy and side effects between acupuncture and conventional medicine therapies up to 2013/06. A total of 12 studies, including 527 patients assessed the efficacy and safety of acupuncture therapy for nerve deafness. Overall, the efficacy of acupuncture was significantly better than that of the conventional western medication (RR: 1.54, 95% CI: 1.36-1.74) or traditional Chinese medicines (RR: 1.51, 95% CI: 1.24-1.84), and the efficacy of acupuncture in combination with conventional western medication or traditional Chinese medicine was better than that of the conventional western medication alone (RR: 1.51, 95% CI: 1.29-1.77) or traditional Chinese medicine alone (RR: 1.59, 95% CI: 1.30-1.95). Based on the comparison of number of deafness patients who were completely cured, the efficacy of acupuncture in combination with traditional Chinese medicines was better than that of traditional Chinese medicine alone (RR: 4.62, 95% CI: 1.38-15.47). Acupuncture therapy can significantly improve the hearing of patients with nerve deafness, and the efficacy of acupuncture in combination with medication is superior to medication alone.

Trial of dextromethorphan/quinidine to treat levodopa-induced dyskinesia in Parkinson's disease.

PubMed

Fox, Susan H; Metman, Leonard Verhagen; Nutt, John G; Brodsky, Matthew; Factor, Stewart A; Lang, Anthony E; Pope, Laura E; Knowles, Nadine; Siffert, João

2017-06-01

Nondopaminergic pathways represent potential targets to treat levodopa-induced dyskinesia in Parkinson's disease (PD). This pilot-study (NCT01767129) examined the safety/efficacy of the sigma-1 receptor-agonist and glutamatergic/monoaminergic modulator, dextromethorphan plus quinidine (to inhibit rapid dextromethorphan metabolism), for treating levodopa-induced dyskinesia. PD patients were randomized to dextromethorphan/quinidine (45 mg/10 mg twice daily)/placebo in two 2-week double-blind, crossover treatment periods, with intervening 2-week washout. After 14 days, a 2-hour intravenous levodopa-infusion was administered. Patient examinations were videotaped before infusion ("off" state) and every 30 minutes during and afterwards until patients returned to "off." The primary endpoint was dyskinesia-severity during infusion measured by Unified Dyskinesia Rating Scale part 3 area-under-curve scores (blinded expert rated). Additional endpoints included other dyskinesia/motor assessments, global measures of clinical-change, and adverse-events. A total of 13 patients were randomized and completed the study (efficacy-evaluable population). Dyskinesia-severity was nonsignificantly lower with dextromethorphan/quinidine than placebo during infusion (area-under-curve 966.5 vs 1048.8; P = .191 [efficacy-evaluable patients]), and significantly lower in a post-hoc sensitivity analysis of the per-protocol-population (efficacy-evaluable patients with ≥ 80% study-drug-compliance, n = 12) when measured from infusion start to 4-hours post-infusion completion (area-under-curve 1585.0 vs 1911.3; P = .024). Mean peak dyskinesia decreased significantly from infusion-start to return to "off" (13.3 vs 14.9; P = .018 [efficacy-evaluable patients]). A total of 9 patients rated dyskinesia "much/very much improved" on dextromethorphan/quinidine versus 1-patient on placebo. Dextromethorphan/quinidine did not worsen PD-motor scores, was generally well tolerated, and was associated with more frequent adverse events. This study provides preliminary evidence of clinical benefit with dextromethorphan/quinidine for treating levodopa-induced dyskinesia in PD. Larger studies with a longer treatment duration need to corroborate these early findings. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

CPAP and behavioral therapies in patients with obstructive sleep apnea: effects on daytime sleepiness, mood, and cognitive function.

PubMed

Sánchez, Ana Isabel; Martínez, Pilar; Miró, Elena; Bardwell, Wayne A; Buela-Casal, Gualberto

2009-06-01

Obstructive sleep apnea (OSA) is a disorder characterized by repeated episodes of complete (apneas) or partial (hypopneas) cessations of breathing while sleeping. While continuous positive airway pressure (CPAP) treatment is commonly chosen to treat OSA, various conservative behavioral therapies are also used, particularly in patients unable to tolerate or benefit from CPAP or who have mild OSA. The principal purpose of these behavioral measures is to reduce risk factors which may underlie or exacerbate the disorder (e.g., weight reduction, smoking cessation, reduction/elimination of alcohol consumption, change in sleeping posture and sleep hygiene). Numerous studies have been conducted to evaluate the efficacy and/or effectiveness of CPAP in treating a wide range of OSA symptomatology. The present study consists of an exhaustive bibliographic search in Medline, PsycINFO, and Cochrane Review (1994-2007) databases and selection of works which have evaluated the efficacy and/or effectiveness of CPAP vis-a-vis daytime sleepiness, depression and cognitive functioning in OSA patients. The selected studies include randomized clinical trials in which CPAP was compared with more conservative measures, sham CPAP and oral placebos. The most important studies which evaluate the efficacy of behavioral treatments for OSA are also reviewed and the most remarkable results are presented. Various conclusions derived from the studies are discussed.

Traditional, complementary, and alternative medicine: Focusing on research into traditional Tibetan medicine in China.

PubMed

Song, Peipei; Xia, Jufeng; Rezeng, Caidan; Tong, Li; Tang, Wei

2016-07-19

As a form of traditional, complementary, and alternative medicine (TCAM), traditional Tibetan medicine has developed into a mainstay of medical care in Tibet and has spread from there to China and then to the rest of the world. Thus far, research on traditional Tibetan medicine has focused on the study of the plant and animal sources of traditional medicines, study of the histology of those plants and animals, chemical analysis of traditional medicines, pharmacological study of those medicines, and evaluation of the clinical efficacy of those medicines. A number of papers on traditional Tibetan medicines have been published, providing some evidence of the efficacy of traditional Tibetan medicine. However, many traditional Tibetan medicines have unknown active ingredients, hampering the establishment of drug quality standards, the development of new medicines, commercial production of medicines, and market availability of those medicines. Traditional Tibetan medicine must take several steps to modernize and spread to the rest of the world: the pharmacodynamics of traditional Tibetan medicines need to be determined, the clinical efficacy of those medicines needs to be verified, criteria to evaluate the efficacy of those medicines need to be established in order to guide their clinical use, and efficacious medicines need to be acknowledged by the pharmaceutical market. The components of traditional Tibetan medicine should be studied, traditional Tibetan medicines should be screened for their active ingredients, and techniques should be devised to prepare and manufacture those medicines.

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.

Effectiveness of the Neonatal Discharge Program for Very Low-Birth-Weight Infants on Parental Efficacy and Psychological Distress.

PubMed

Shandra Bos, Lakshmi; Shorey, Shefaly; Kulantaipian, Tamill Salvee; Sng, Jane S P; Tam, Wilson W S; Koh, Serena S L

2018-05-17

This pilot study aimed to (i) evaluate the effectiveness of a neonatal discharge program, (ii) identify relationships between parent and infant factors and parental efficacy and psychological distress, and (iii) identify ways to improve the neonatal discharge program. A quasiexperimental 1-group pretest/posttest design was used. Through consecutive sampling, 42 participants were recruited. Data were collected using self-report questionnaires. Self-administering instruments gathered data on parental efficacy and psychological distress as well as feedback and recommendations on the intervention. A significant increase in parental efficacy and a reduction in psychological distress were observed from pre- to postdischarge intervention. Significant relationships were found between parental efficacy and infants' gestational age, birth weight, gender, and participants' level of education, and a significant relationship was found between psychological distress and number of children from previous pregnancies. Moreover, an Internet-based program, in addition to the face-to-face teaching, was identified as a preferred option to aid in information retention. It is important to evaluate and enhance the neonatal discharge program to suit the parents of today while providing them with informational and emotional support. Future studies should explore parental coping and the long-term effects of their infant's birth and the intervention.

A systematic review of types and efficacy of online interventions for cancer patients.

PubMed

McAlpine, Heidi; Joubert, Lynette; Martin-Sanchez, Fernando; Merolli, Mark; Drummond, Katharine J

2015-03-01

This review examines the evidence-based literature surrounding the use of online resources for adult cancer patients. The focus is online resources that connect patients with their healthcare clinician and with supportive and educational resources, their efficacy and the outcome measures used to assess them. The following databases were systematically searched for relevant literature: MEDLINE, PsychINFO, Cochrane Central Register of Controlled Trials, CINAHL, Inspec and Computers and Applied Science. Included were studies conducted in an outpatient setting, and reporting a measurable, clinically relevant outcome. Fourteen studies satisfied the inclusion criteria. The efficacy of online interventions was varied, with some demonstrating positive effects on quality of life and related measures, and two demonstrating poorer outcomes for intervention participants. The majority of interventions reported mixed results. Included interventions were too heterogeneous for meta-analysis. The overall benefit of online interventions for cancer patients is unclear. Although there is a plethora of interventions reported without analysis, current interventions demonstrate mixed efficacy of limited duration when rigorously evaluated. The efficacy of on-line interventions for cancer patients is unclear. All on-line interventions should be developed using the available evidence-base and rigorously evaluated to expand our understanding of this area. Crown Copyright © 2014. Published by Elsevier Ireland Ltd. All rights reserved.

Distinguishing perceived competence and self-efficacy: an example from exercise.

PubMed

Rodgers, Wendy M; Markland, David; Selzler, Anne-Marie; Murray, Terra C; Wilson, Philip M

2014-12-01

This article examined the conceptual and statistical distinction between perceived competence and self-efficacy. Although they are frequently used interchangeably, it is possible that distinguishing them might assist researchers in better understanding their roles in developing enduring adaptive behavior patterns. Perceived competence is conceived in the theoretical framework of self-determination theory and self-efficacy is conceived in the theoretical framework of social-cognitive theory. The purpose of this study was to empirically distinguish perceived competence from self-efficacy for exercise. Two studies evaluated the independence of perceived competence and self-efficacy in the context of exercise. Using 2 extant instruments with validity and reliability evidence in exercise contexts, the distinctiveness of the 2 constructs was assessed in 2 separate samples (n = 357 middle-aged sedentary adults; n = 247 undergraduate students). Confirmatory factor analysis supported the conceptual and empirical distinction of the 2 constructs. This study supports the conceptual and statistical distinction of perceived competence from perceived self-efficacy. Applications of these results provide a rationale for more precise future theorizing regarding their respective roles in supporting initiation and maintenance of health behaviors.

Evaluation of an intervention to increase self-efficacy for independent exercise in cardiac rehabilitation.

PubMed

Barkley, Sherry A; Fahrenwald, Nancy L

2013-01-01

Adherence to independent exercise is an essential outcome of cardiac rehabilitation (CR), yet limited theory-based interventions to improve adherence exist. This study tested the effects of an intervention based on Bandura's conceptualization of self-efficacy. The self-efficacy coaching intervention (SCI), a supplement to standard care, was designed to increase self-efficacy for independent exercise and independent exercise behavior in CR. We examined whether the SCI vs. attention control (AC) resulted in improved exercise self-efficacy (ESE), barriers self-efficacy (BARSE), and minutes of independent exercise for CR participants (n = 65). While between-group differences did not reach significance (p > .10) for any of the outcome measures, significant within-group changes were noted in BARSE scores and independent exercise (p < .001) for the SCI group. Change in independent exercise for the AC group was also significant (p =. 006). Further study is needed to explore whether short-term changes translate into maintenance of independent exercise participation after program completion.

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…

Will I Succeed in Middle School? A Longitudinal Analysis of Self-Efficacy in School Transitions in Relation to Goal Structures and Engagement

ERIC Educational Resources Information Center

Madjar, Nir; Chohat, Ronny

2017-01-01

The current study aimed to explore the concept of transition self-efficacy, which is defined as individuals' subjective evaluation of their ability to execute the actions required for a successful transition from elementary to middle school. The study followed a sample of 128 sixth-grade students for 2 consecutive years (before and after the…

Feasibility and Preliminary Efficacy of the Fit4Fun Intervention for Improving Physical Fitness in a Sample of Primary School Children: A Pilot Study

ERIC Educational Resources Information Center

Eather, Narelle; Morgan, Philip J.; Lubans, David R.

2013-01-01

Objective: The primary objective of this study was to evaluate the feasibility and preliminary efficacy of a school-based physical fitness intervention (Fit4Fun) on the physical fitness and physical activity (PA) levels of primary school children. Methods: A group-randomized controlled trial with a 3-month wait-list control group was conducted in…

Computer Assisted Language Testing: On the Efficacy of Web-Based Approach in the Instruction of Elementary Learners of English

ERIC Educational Resources Information Center

Soleimani, Maryam; Gahhari, Shima

2012-01-01

In this study the effectiveness and efficacy of e-learning was evaluated through a web based approach. Two classes of elementary learners of English were selected for this study, one class received a six month instruction through the typical twice a week classes and the other one was instructed through internet, in other words, the first class did…

Immortalized Muscle Cell Model to Test the Exon Skipping Efficacy for Duchenne Muscular Dystrophy

PubMed Central

Nguyen, Quynh

2017-01-01

Duchenne muscular dystrophy (DMD) is a lethal genetic disorder that most commonly results from mutations disrupting the reading frame of the dystrophin (DMD) gene. Among the therapeutic approaches employed, exon skipping using antisense oligonucleotides (AOs) is one of the most promising strategies. This strategy aims to restore the reading frame, thus producing a truncated, yet functioning dystrophin protein. In 2016, the Food and Drug Administration (FDA) conditionally approved the first AO-based drug, eteplirsen (Exondys 51), developed for DMD exon 51 skipping. An accurate and reproducible method to quantify exon skipping efficacy is essential for evaluating the therapeutic potential of different AOs sequences. However, previous in vitro screening studies have been hampered by the limited proliferative capacity and insufficient amounts of dystrophin expressed by primary muscle cell lines that have been the main system used to evaluate AOs sequences. In this paper, we illustrate the challenges associated with primary muscle cell lines and describe a novel approach that utilizes immortalized cell lines to quantitatively evaluate the exon skipping efficacy in in vitro studies. PMID:29035327

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.

Ursodiol in patients with parenteral nutrition-associated cholestasis.

PubMed

San Luis, Valerie A; Btaiche, Imad F

2007-11-01

To review the role of ursodeoxycholic acid (ursodiol) in treating parenteral nutrition-associated cholestasis (PNAC). A MEDLINE (1950-May 2007) search was performed using the key terms parenteral nutrition, cholestasis, ursodeoxycholic acid, and ursodiol. All English-language articles that evaluated the safety and efficacy of ursodiol for PNAC were included in this review. The benefits of exogenous ursodiol administration in the treatment of cholestasis can be explained by its alteration of effects on bile composition and flow and provision of cytoprotective, membrane stabilizing, and immunomodulatory effects. Two animal studies, 2 case reports, and 6 human studies (2 prospective and 3 retrospective pediatric studies, 1 adult prospective study) evaluated the efficacy of ursodiol in patients with PNAC. Ursodiol 10-30 mg/kg/day in children and 10-15 mg/kg/day in adults administered in 2-3 doses improved the biochemical and clinical signs and symptoms of PNAC. However, short-term improvement in biochemical parameters may not necessarily predict the outcome of PNAC patients. At recommended doses, ursodiol may not be effective in patients with short bowel syndrome or in those with resected terminal ileum because of reduced ursodiol absorption. Studies supporting the efficacy of ursodiol in treatment of PNAC are limited by small sample size, absence of randomization and controls, short duration, and lack of accountancy to confounding variables. Large, prospective, randomized, placebo-controlled, long-term follow-up studies evaluating the efficacy and optimal dosing and duration of ursodiol therapy for PNAC are not yet available. Ursodiol may improve the biochemical signs and clinical symptoms of PNAC. However, optimal dosing, timing, duration of therapy, and long-term effects on PNAC outcome and prognosis require further studies.

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

Family Efficacy within Ethnically Diverse Families: A Qualitative Study.

PubMed

Kao, Tsui-Sui A; Caldwell, Cleopatra H

2017-03-01

Family efficacy, which refers to a family's belief in its ability to produce a desired outcome, has been shown to protect adolescents from risky health behaviors. Few studies have examined family efficacy within diverse populations, however, and understanding of how efficacy is framed and formed within the context of cultural and familial values is limited. This descriptive qualitative study examined sources of family efficacy within ethnically and socioeconomically diverse families, evaluating how such families develop and exercise family efficacy with the intent to protect adolescents from risky health behaviors (i.e., marijuana and alcohol use and early sexual activity). We collected qualitative data via two semi-structured interviews, 4-6 months apart, with 31 adolescents (ages 12-14) and their parent/s, for total of 148 one-on-one interviews. Thematic analysis identified three distinct domains of family efficacy: relational, pragmatic, and value-laden. Prior experiences and cultural background influenced the domain/s utilized by families. Significantly, families that consistently tapped into all three domains were able to effectively manage personal and family difficulties; these families also had family strategies in place to prevent adolescents from risky behaviors. Health professionals could utilize this concept of multidimensional family efficacy to promote health within culturally diverse families. © 2015 Family Process Institute.

Efficacy evaluation of a commercial neem cake for control of Haematobia irritans on Nelore cattle.

PubMed

Chagas, Ana Carolina de Souza; Oliveira, Márcia Cristina de Sena; Giglioti, Rodrigo; Calura, Fernando Henrique; Ferrenzini, Jenifer; Forim, Moacir Rossi; Barros, Antonio Thadeu Medeiros de

2010-01-01

Much attention has been given to the development of botanical insecticides to provide effective natural control of cattle ectoparasites without harming animals, consumers, and environment. This study evaluated the efficacy of a commercial neem cake in controlling Haematobia irritans infestation on cattle. The study was conducted at the Embrapa Southeast Cattle Research Center (CPPSE), in São Carlos, SP, Brazil, from April to July 2008. The neem cake mixed in mineral salt in a 2% concentration was provided to 20 Nelore cows during nine weeks and had its efficacy evaluated by comparison of the infestation level against a control group. Fly infestations were recorded weekly by digital photographs of each animal from both groups and the number of flies was later counted in a computer-assisted image analyzer. Quantification of neem cake components by high-performance liquid chromatography revealed the presence of azadirachtin (421 mg.kg(-1)) and 3-tigloyl-azadirachtol (151 mg.kg(-1)) in the tested neem cake. Addition of the 2% neem cake reduced mineral salt intake in about 22%. The 2% neem cake treatment failed to reduce horn fly infestations on cattle during the 9-week study period.

Data analysis of response interruption and redirection as a treatment for vocal stereotypy.

PubMed

Wunderlich, Kara L; Vollmer, Timothy R

2015-12-01

Vocal stereotypy, or repetitive, noncontextual vocalizations, is a problematic form of behavior exhibited by many individuals with autism spectrum disorder (ASD). Recent research has evaluated the efficacy of response interruption and redirection (RIRD) in the reduction of vocal stereotypy. Research has indicated that RIRD often results in reductions in the level of vocal stereotypy; however, many previous studies have only presented data on vocal stereotypy that occurred outside RIRD implementation. The current study replicated the procedures of previous studies that have evaluated the efficacy of RIRD and compared 2 data-presentation methods: inclusion of only data collected outside RIRD implementation and inclusion of all vocal stereotypy data from the entirety of each session. Subjects were 7 children who had been diagnosed with ASD. Results indicated that RIRD appeared to be effective when we evaluated the level of vocal stereotypy outside RIRD implementation, but either no reductions or more modest reductions in the level of vocal stereotypy during the entirety of sessions were obtained for all subjects. Results suggest that data-analysis methods used in previous research may overestimate the efficacy of RIRD. © Society for the Experimental Analysis of Behavior.

Learning when Serious: Psychophysiological Evaluation of a Technology-Enhanced Learning Game

ERIC Educational Resources Information Center

Cowley, Ben; Fantato, Martino; Jennett, Charlene; Ruskov, Martin; Ravaja, Niklas

2014-01-01

We report an evaluation study for a novel learning platform, motivated by the growing need for methods to do assessment of serious game efficacy. The study was a laboratory experiment combining evaluation methods from the fields of learning assessment and psychophysiology. 15 participants used the TARGET game platform for 25 minutes, while the…

Evidence-Based Psychosocial Treatments for Adolescents with Disruptive Behavior

PubMed Central

McCart, Michael R.; Sheidow, Ashli J.

2016-01-01

Objective This article updates the earlier reviews of evidence-based psychosocial treatments for disruptive behavior in adolescents (Brestan & Eyberg, 1998; Eyberg, Nelson, & Boggs, 2008), focusing primarily on the treatment literature published from 2007 to 2014. Method Studies were identified through an extensive literature search and evaluated using Journal of Clinical Child and Adolescent Psychology (JCCAP) level of support criteria, which classify studies as well established, probably efficacious, possibly efficacious, experimental, or of questionable efficacy based on existing evidence. The JCCAP criteria have undergone modest changes in recent years. Thus, in addition to evaluating new studies from 2007–2014 for this update, all adolescent-focused articles that had been included in the 1998 and 2008 reviews were re-examined. In total, 86 empirical papers published over a 48-year period and covering 50 unique treatment protocols were identified and coded. Results Two multicomponent treatments that integrate strategies from family, behavioral, and cognitive-behavioral therapy met criteria as well established. Summaries are provided for those treatments, as well as for two additional multicomponent treatments and two cognitive-behavioral treatments that met criteria as probably efficacious. Treatments designated as possibly efficacious, experimental, or of questionable efficacy are listed. Additionally, moderator/mediator research is summarized. Conclusions Results indicate that since the prior reviews, there has been a noteworthy expansion of research on treatments for adolescent disruptive behavior, particularly treatments that are multicomponent in nature. Despite these advances, more research is needed to address key gaps in the field. Implications of the findings for future science and clinical practice are discussed. PMID:27152911

Antitumor Efficacy Testing in Rodents

PubMed Central

2008-01-01

The preclinical research and human clinical trials necessary for developing anticancer therapeutics are costly. One contributor to these costs is preclinical rodent efficacy studies, which, in addition to the costs associated with conducting them, often guide the selection of agents for clinical development. If inappropriate or inaccurate recommendations are made on the basis of these preclinical studies, then additional costs are incurred. In this commentary, I discuss the issues associated with preclinical rodent efficacy studies. These include the identification of proper preclinical efficacy models, the selection of appropriate experimental endpoints, and the correct statistical evaluation of the resulting data. I also describe important experimental design considerations, such as selecting the drug vehicle, optimizing the therapeutic treatment plan, properly powering the experiment by defining appropriate numbers of replicates in each treatment arm, and proper randomization. Improved preclinical selection criteria can aid in reducing unnecessary human studies, thus reducing the overall costs of anticancer drug development. PMID:18957675

Efficacy and tolerance of systemic steroids in sciatica: a systematic review and meta-analysis.

PubMed

Roncoroni, Cécile; Baillet, Athan; Durand, Marjorie; Gaudin, Philippe; Juvin, Robert

2011-09-01

The efficacy of pharmacological interventions in sciatica is limited and the use of systemic steroids is still controversial. We aimed at evaluating the efficacy and tolerance of systemic steroids in sciatica. A systematic literature search was performed in the Medline, Embase and Cochrane databases until February 2010. Randomized placebo-controlled trials evaluating the efficacy and the tolerance of systemic steroids in sciatica were included. Efficacy and tolerance were assessed using the relative risk (RR) and 95% CI with the inverse variance method (RR > 1 means that the event is more likely to occur in the steroid group). We explored the heterogeneity between the studies using subgroup analysis. Seven studies (383 patients) were included. The difference in the rate of responders between both groups was not statistically significant (RR = 1.22, 95% CI 0.96, 1.56). The rate of adverse events was 13.3% for the patients in the steroid group and 6.6% for the placebo group (RR = 2.01, 95% CI 1.06, 3.80). The number needed to harm was 20 (95% CI 10, ∞). Twenty (15.3%) patients in the steroid group and seven (5.7%) patients in the placebo group underwent surgery. A trend towards a higher requirement for spinal surgery was observed in the steroid group (RR = 1.14, 95% CI 0.74, 1.75). The methodological quality slightly influenced the results. We did not find any publication bias. Steroid efficacy is not superior to the placebo in sciatica, but it has more side effects. The tolerance : efficacy ratio indicates against the use of systemic steroids in sciatica.

[Self-efficacy and physical activity in adolescents in Curitiba, Paraná State, Brazil].

PubMed

de Souza, Carla Adriane; Rech, Cassiano Ricardo; Sarabia, Tais Taiana; Añez, Ciro Romelio Rodriguez; Reis, Rodrigo Siqueira

2013-10-01

This study aimed to examine the association between physical activity and self-efficacy in adolescents. A school-based survey was conducted with 1,698 adolescents from Curitiba, Paraná State, Brazil. Physical activity was evaluated as weekly frequency (days per week) of moderate or vigorous physical activity. Self-efficacy was analyzed as the sum of a 10-item scale. The association between self-efficacy and physical activity was tested by Poisson regression (p < 0.05), stratified by gender. Among boys, only high self-efficacy was associated with all categories of physical activity (p < 0.001), while for girls moderate and high levels of self-efficacy were associated with all categories of physical activity (p < 0.001). In conclusion, self-efficacy showed a positive association with physical activity in adolescents, although the relationship was more consistent in girls. The finding is important for designing interventions to promote physical activity in this age group.

Efficacy, Tolerability, and Dose-Dependent Effects of Opioid Analgesics for Low Back Pain: A Systematic Review and Meta-analysis.

PubMed

Abdel Shaheed, Christina; Maher, Chris G; Williams, Kylie A; Day, Richard; McLachlan, Andrew J

2016-07-01

Opioid analgesics are commonly used for low back pain, however, to our knowledge there has been no systematic evaluation of the effect of opioid dose and use of enrichment study design on estimates of treatment effect. To evaluate efficacy and tolerability of opioids in the management of back pain; and investigate the effect of opioid dose and use of an enrichment study design on treatment effect. Medline, EMBASE, CENTRAL, CINAHL, and PsycINFO (inception to September 2015) with citation tracking from eligible randomized clinical trials (RCTs). Placebo-controlled RCTs in any language. Two authors independently extracted data and assessed risk of bias. Data were pooled using a random effects model with strength of evidence assessed using the grading of recommendations assessment, development, and evaluation (GRADE). The primary outcome measure was pain. Pain and disability outcomes were converted to a common 0 to 100 scale, with effects greater than 20 points considered clinically important. Of 20 included RCTs of opioid analgesics (with a total of 7925 participants), 13 trials (3419 participants) evaluated short-term effects on chronic low back pain, and no placebo-controlled trials enrolled patients with acute low back pain. In half of these 13 trials, at least 50% of participants withdrew owing to adverse events or lack of efficacy. There was moderate-quality evidence that opioid analgesics reduce pain in the short term; mean difference (MD), -10.1 (95% CI, -12.8 to -7.4). Meta-regression revealed a 12.0 point greater pain relief for every 1 log unit increase in morphine equivalent dose (P = .046). Clinically important pain relief was not observed within the dose range evaluated (40.0-240.0-mg morphine equivalents per day). There was no significant effect of enrichment study design. For people with chronic low back pain who tolerate the medicine, opioid analgesics provide modest short-term pain relief but the effect is not likely to be clinically important within guideline recommended doses. Evidence on long-term efficacy is lacking. The efficacy of opioid analgesics in acute low back pain is unknown.

A comparative laboratory trial evaluating the immediate efficacy of fluralaner, afoxolaner, sarolaner and imidacloprid + permethrin against adult Rhipicephalus sanguineus (sensu lato) ticks attached to dogs.

PubMed

Burgio, Federica; Meyer, Leon; Armstrong, Rob

2016-12-03

Acaricides are used to treat and prevent tick infestations, and a common clinical scenario is to administer an acaricide on observing an attached tick. Consequently, immediate acaricidal efficacy (onset of activity and speed of kill) results are clinically valuable. This study evaluated the immediate efficacy of four commercially available acaricides against adult Rhipicephalus sanguineus (sensu lato). Forty dogs were blocked on hair length and tick carrying capacity, then randomly assigned to receive one of four treatments (fluralaner, sarolaner, imidacloprid + permethrin, or afoxolaner) or left untreated as controls. All dogs were challenged with 50 adult R. sanguineus (s.l.) ticks 48 h prior to treatment. After treatment, in situ tick thumb counts were conducted at 2, 4, 8, 12 and 24 h; thereafter ticks were removed and counted at 48 h. Imidacloprid + permethrin had the earliest onset of activity at 2 h (36.9% efficacy) followed at 4 h by fluralaner (60.2% efficacy) and sarolaner (48.2% efficacy), and lastly afoxolaner at 8 h (90.8% efficacy). Three oral treatments had an 8 h speed of kill (>90% efficacy) threshold; with corresponding efficacies as: fluralaner (99.6%), sarolaner (94.7%) and afoxolaner (90.8%). Fluralaner and sarolaner achieved 100% efficacy at 12, 24 and 48 h; afoxolaner achieved 100% efficacy at 48 h. Imidacloprid + permethrin achieved 80.1% efficacy at 48 h, therefore, failing to attain the speed of kill 90% efficacy threshold. The systemically distributed isoxazolines performed much better than cutaneously distributed imidacloprid + permethrin and are optimal treatment choices against attached ticks based on the combination of earlier onset of activity and speed of kill. Fluralaner had a 4 h onset of activity, an 8 h speed of kill and achieved 100% efficacy at 12 h.

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.

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.

The Efficacy and Safety of Mainstream Medications for Patients With cDMARD-Naïve Rheumatoid Arthritis: A Network Meta-Analysis.

PubMed

Cai, Weiyan; Gu, Youyi; Cui, Huanqin; Cao, Yinyin; Wang, Xiaoliang; Yao, Yi; Wang, Mingyu

2018-01-01

Background: The mainstream medications for rheumatoid arthritis (RA) include conventional disease-modifying antirheumatic drugs (cDMARDs), which mostly are methotrexate (MTX), and biologic agents such as adalimumab (ADA), certolizumab (CZP), etanercept (ETN), golimumab (GOL), infliximab (IFX), and tocilizumab (TCZ). This network meta-analysis was aimed at evaluating the efficacy and safety of the medications above and interventions combining cDMARDs and biologic agents for patients with RA. Methods: PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov were searched systematically for eligible randomized controlled trials (RCTs). Outcomes concerning efficacy and safety were evaluated utilizing odds ratios (ORs) and 95% credible intervals ( CrI ). The outcomes of efficacy would be evaluated through remission and American College of Rheumatology (ACR) scores. The surface under the cumulative ranking curve (SUCRA) was calculated to rank each treatment on each index. Results: A total of 20 RCTs with 9,047 patients were included, and the efficacy and safety of the concerning interventions for RA were evaluated. Compared with cDMARDs alone, TCZ+MTX, ETN+MTX, IFX+MTX, TCZ, and ADA+MTX showed significant statistical advantage on ACR20, ACR50, and ACR70. Apart from that, as for remission, TCZ+MTX, IFX+MTX, TCZ, and CZP+MTX performed better compared to cDMARDs alone. The SUCRA ranking also indicated that TCZ+MTX was the intervention with best ranking in the entire four efficacy indexes followed by ETX+MTX and IFX+MTX. However, there was no obvious difference among these medications compared with cDMARDs when it comes to safety, which need more specific studies on that. Conclusion: TCZ+MTX was potentially the most recommended combination of medications for RA due to its good performance in all outcomes of efficacy. ETX+MTX and IFX+MTX, which also performed well, could be introduced as alternative treatments. However, considering the adverse events, the treatments concerning should be introduced with caution.

An open-label study to evaluate the long-term safety and efficacy of lanadelumab for prevention of attacks in hereditary angioedema: design of the HELP study extension.

PubMed

Riedl, Marc A; Bernstein, Jonathan A; Craig, Timothy; Banerji, Aleena; Magerl, Markus; Cicardi, Marco; Longhurst, Hilary J; Shennak, Mustafa M; Yang, William H; Schranz, Jennifer; Baptista, Jovanna; Busse, Paula J

2017-01-01

Hereditary angioedema (HAE) is characterized by recurrent attacks of subcutaneous or submucosal edema. Attacks are unpredictable, debilitating, and have a significant impact on quality of life. Patients may be prescribed prophylactic therapy to prevent angioedema attacks. Current prophylactic treatments may be difficult to administer (i.e., intravenously), require frequent administrations or are not well tolerated, and breakthrough attacks may still occur frequently. Lanadelumab is a subcutaneously-administered monoclonal antibody inhibitor of plasma kallikrein in clinical development for prophylaxis of hereditary angioedema attacks. A Phase 1b study supported its efficacy in preventing attacks. A Phase 3, randomized, double-blind, placebo-controlled, parallel-arm study has been completed and an open-label extension is currently ongoing. The primary objective of the open-label extension is to evaluate the long-term safety of repeated subcutaneous administrations of lanadelumab in patients with type I/II HAE. Secondary objectives include evaluation of efficacy and time to first angioedema attack to determine outer bounds of the dosing interval. The study will also evaluate immunogenicity, pharmacokinetics/pharmacodynamics, quality of life, characteristics of breakthrough attacks, ease of self-administration, and safety/efficacy in patients who switch to lanadelumab from another prophylactic therapy. The open-label extension will enroll patients who completed the double-blind study ("rollover patients") and those who did not participate in the double-blind study ("non-rollover patients"), which includes patients who may or may not be currently using another prophylactic therapy. Rollover patients will receive a single 300 mg dose of lanadelumab on Day 0 and the second dose after the patient's first confirmed angioedema attack. Thereafter, lanadelumab will be administered every 2 weeks. Non-rollover patients will receive 300 mg lanadelumab every 2 weeks regardless of the first attack. All patients will receive their last dose on Day 350 (maximum of 26 doses), and will then undergo a 4-week follow-up. Prevention of attacks can reduce the burden of illness associated with HAE. Prophylactic therapy requires extended, repeated dosing and the results of this study will provide important data on the long-term safety and efficacy of lanadelumab, a monoclonal antibody inhibitor of plasma kallikrein for subcutaneous administration for the treatment of HAE. Trial registration NCT02741596.

Raising Children's Self-Efficacy through Parental Involvement in Homework

ERIC Educational Resources Information Center

Williams, Keith; Swift, Jennifer; Williams, Hefin; Van Daal, Victor

2017-01-01

Background: This paper is a qualitative evaluation of a small-scale pilot study that attempted to generate parental involvement in children's learning. It used problem-solving mathematics homework in order to raise the children's self-efficacy, or, put another way, the child's belief that success lies in their own hands. Purpose: Homework is often…

Relationship Interventions during the Transition to Parenthood: Issues of Timing and Efficacy

ERIC Educational Resources Information Center

Trillingsgaard, Tea; Baucom, Katherine J. W.; Heyman, Richard E.; Elklit, Ask

2012-01-01

This study evaluated the efficacy of the Prevention and Relationship Enhancement Program (PREP) adapted for Danish couples expecting their first child. Couples were recruited consecutively through a public maternity ward (N = 290). On the basis of due dates, they were allocated to (a) PREP, (b) an information-based control group (INFO), or (c)…

Taiwan College Students' Self-Efficacy and Motivation of Learning in Online Peer Assessment Environments

ERIC Educational Resources Information Center

Tseng, Sheng-Chau; Tsai, Chin-Chung

2010-01-01

Online peer assessment is an innovative evaluation method that has caught both educators' and practitioners' attention in recent years. The purpose of this study was to develop relevant questionnaires for teachers to understand student self-efficacy and motivation in online peer assessment learning environments. A total of 205 college students…

The Effect of Using Computer Skills on Teachers' Perceived Self-Efficacy Beliefs towards Technology Integration, Attitudes and Performance

ERIC Educational Resources Information Center

EL-Daou, Badrie Mohammad Nour

2016-01-01

The current study analyzes the relationship between the apparent teacher's self-efficacy and attitudes towards integrating technology into classroom teaching, self-evaluation reports and computer performance results. Pre-post measurement of the Computer Technology Integration Survey (CTIS) (Wang et al, 2004) was used to determine the confidence…

The Effect of Using in Computer Skills on Teachers' Perceived Self-Efficacy Beliefs towards Technology Integration, Attitudes and Performance

ERIC Educational Resources Information Center

EL-Daou, Badrie Mohammad Nour

2016-01-01

The current study analyzes the relationship between the apparent teacher's self-efficacy and attitudes towards integrating technology into classroom teaching, self-evaluation reports and computer performance results. Pre-post measurement of the Computer Technology Integration Survey (CTIS) (Wang et al, 2004) was used to determine the confidence…

Examining the Efficacy of Management for Pennsylvania School Health Programs

ERIC Educational Resources Information Center

Jacobi, Wendy J.

2010-01-01

In Pennsylvania, certified school nurses were governed by the same educational rules and administrative directives as teachers. School nurses were supervised and evaluated by non-nurse managers who had no knowledge of the scope of school nurse practice. A focus of the study was to examine the efficacy of management for school health programs. The…

Efficacy of Cognitive-Behavioral Therapy for Comorbid Panic Disorder with Agoraphobia and Generalized Anxiety Disorder

ERIC Educational Resources Information Center

Labrecque, Joane; Marchand, Andre; Dugas, Michel J.; Letarte, Andree

2007-01-01

The goal of this study was to evaluate the efficacy of cognitive-behavioral therapy for comorbid panic disorder with agoraphobia (PDA) and generalized anxiety disorder (GAD) by combining treatment strategies for both disorders. A single-case, multiple-baseline design across participants was used. Three participants with primary PDA and secondary…

Efficacy of a Web-Based, Tailored, Alcohol Prevention/Intervention Program for College Students: 3-Month Follow-Up

ERIC Educational Resources Information Center

Bingham, C. Raymond; Barretto, Andrea Ippel; Walton, Maureen A.; Bryant, Christopher M.; Shope, Jean T.; Raghunathan, Trivellore E.

2011-01-01

This study presents the results of an efficacy evaluation of a web-based brief motivational alcohol prevention/intervention program called "Michigan Prevention and Alcohol Safety for Students" (M-PASS). Four on-line sessions providing individually-tailored feedback were delivered to first-year college students over 9 weeks. Non- and…

Cognitive Behavioral Guided Self-Help for the Treatment of Recurrent Binge Eating

ERIC Educational Resources Information Center

Striegel-Moore, Ruth H.; Wilson, G. Terence; DeBar, Lynn; Perrin, Nancy; Lynch, Frances; Rosselli, Francine; Kraemer, Helena C.

2010-01-01

Objective: Despite proven efficacy of cognitive behavioral therapy (CBT) for treating eating disorders with binge eating as the core symptom, few patients receive CBT in clinical practice. Our blended efficacy-effectiveness study sought to evaluate whether a manual-based guided self-help form of CBT (CBT-GSH), delivered in 8 sessions in a health…

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…

Efficacy of an Acceptance-Based Behavior Therapy for Generalized Anxiety Disorder: Evaluation in a Randomized Controlled Trial

ERIC Educational Resources Information Center

Roemer, Lizabeth; Orsillo, Susan M.; Salters-Pedneault, Kristalyn

2008-01-01

Generalized anxiety disorder (GAD) is a chronic anxiety disorder, associated with comorbidity and impairment in quality of life, for which improved psychosocial treatments are needed. GAD is also associated with reactivity to and avoidance of internal experiences. The current study examined the efficacy of an acceptance-based behavioral therapy…

Elementary Teacher Perceptions of Principal Leadership, Teacher Self-Efficacy in Math and Science, and Their Relationships to Student Academic Achievement

ERIC Educational Resources Information Center

Richard, Bertha Cookie

2013-01-01

The purpose of this study was to investigate elementary teacher perceptions of elementary principal instructional leadership and elementary teacher evaluation of self-efficacy at low and high performing low socio-economic elementary schools. These variables were examined to determine whether relationships with math and science academic achievement…

78 FR 36750 - Information Collection; Submission for OMB Review, Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... (ICR) entitled Senior Corps Independent Living Impact Evaluation Study for review and approval in... Independent Living Impact Evaluation Study. This project will assess the impact of the Senior Companion Program on clients' self-efficacy, life satisfaction, and perceived social ties and social supports...

Goal orientation and self-efficacy in relation to memory in adulthood

PubMed Central

Hastings, Erin C.; West, Robin L.

2011-01-01

The achievement goal framework (Dweck, 1986) has been well-established in children and college-students, but has rarely been examined empirically with older adults. The current study, including younger and older adults, examined the effects of memory self-efficacy, learning goals (focusing on skill mastery over time) and performance goals (focusing on performance outcome evaluations) on memory performance. Questionnaires measured memory self-efficacy and general orientation toward learning and performance goals; free and cued recall was assessed in a subsequent telephone interview. As expected, age was negatively related and education was positively related to memory self-efficacy, and memory self-efficacy was positively related to memory, in a structural equation model. Age was also negatively related to memory performance. Results supported the positive impact of learning goals and the negative impact of performance goals on memory self-efficacy. There was no significant direct effect of learning or performance goals on memory performance; their impact occurred via their effect on memory self-efficacy. The present study supports past research suggesting that learning goals are beneficial, and performance goals are maladaptive, for self-efficacy and learning, and validates the achievement goal framework in a sample including older adults. PMID:21728891

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.

Efficacy Evaluation of Current and Future Naval Mine Warfare Neutralization Method

DTIC Science & Technology

2016-12-01

Distribution is unlimited. EFFICACY EVALUATION OF CURRENT AND FUTURE NAVAL MINE WARFARE NEUTRALIZATION METHOD by Team MIW Cohort SE311-152O...EFFICACY EVALUATION OF CURRENT AND FUTURE NAVAL MINE WARFARE NEUTRALIZATION METHOD 5. FUNDING NUMBERS 6. AUTHOR (S) Team MIW, Systems Engineering...NEUTRALIZATION METHOD Team MIW, Systems Engineering Cohort SE311-152O Submitted in partial fulfillment of the requirements for the degrees of

In vivo tissue distribution and efficacy studies for cyclosporin A loaded nano-decorated subconjunctival implants.

PubMed

Yavuz, Burçin; Bozdağ Pehlivan, Sibel; Kaffashi, Abbas; Çalamak, Semih; Ulubayram, Kezban; Palaska, Erhan; Çakmak, Hasan Basri; Ünlü, Nurşen

2016-11-01

Biodegradable implants are promising drug delivery systems for sustained release ocular drug delivery with the benefits such as minimum systemic side effects, constant drug concentration at the target site and getting cleared without surgical removal. Dry eye syndrome (DES) is a common disease characterized with the changes in ocular epithelia surface and results in inflammatory reaction that might lead to blindness. Cyclosporin A (CsA) is a cyclic peptide that is frequently employed for the treatment of DES and it needs to be applied several times a day in tear drops form. The aim of this study was to evaluate in vivo behavior and efficacy of the developed nano-decorated subconjunctival implant systems for sustained release CsA delivery. Biodegradable Poly-ɛ-caprolactone (PCL) implant or micro-fiber implants containing CsA loaded poly-lactide-co-glycolide (85:15) (PLGA) or PCL nanoparticles were prepared in order to achieve sustained release. Two of the formulations PCL-PLGA-NP-F and PCL-PCL-NP-I were selected for in vivo evaluation based on their in vitro characteristics determined in our previous study. In this study, formulations were implanted to Swiss Albino mice with induced dry eye syndrome to investigate the ocular distribution of CsA following subconjunctival implantation and to evaluate the efficacy. Tissue distribution study indicated that CsA was present in ocular tissues such as cornea, sclera and lens even 90 days after the application and blood CsA levels were found lower than ocular tissues. Efficacy studies also showed that application of CsA-loaded fiber implant formulation resulted in faster recovery based on their staining scores.

Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies.

PubMed

Fleischmann, Roy; Kremer, Joel; Tanaka, Yoshiya; Gruben, David; Kanik, Keith; Koncz, Tamas; Krishnaswami, Sriram; Wallenstein, Gene; Wilkinson, Bethanie; Zwillich, Samuel H; Keystone, Edward

2016-12-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1-30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA. Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice daily in Phase 2 studies are the focus of this review. Tofacitinib ≥ 5 mg twice daily was efficacious in a dose-dependent manner, with statistically significant and clinically meaningful reductions in the signs and symptoms of RA and patient-reported outcomes. The safety profile was consistent across studies. The efficacy and safety profile of tofacitinib in Phase 2 studies supported its further investigation and the selection of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily for evaluation in Phase 3 studies. © 2016 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

A Sequential Phase 2b Trial Design for Evaluating Vaccine Efficacy and Immune Correlates for Multiple HIV Vaccine Regimens

PubMed Central

Gilbert, Peter B.; Grove, Douglas; Gabriel, Erin; Huang, Ying; Gray, Glenda; Hammer, Scott M.; Buchbinder, Susan P.; Kublin, James; Corey, Lawrence; Self, Steven G.

2012-01-01

Five preventative HIV vaccine efficacy trials have been conducted over the last 12 years, all of which evaluated vaccine efficacy (VE) to prevent HIV infection for a single vaccine regimen versus placebo. Now that one of these trials has supported partial VE of a prime-boost vaccine regimen, there is interest in conducting efficacy trials that simultaneously evaluate multiple prime-boost vaccine regimens against a shared placebo group in the same geographic region, for accelerating the pace of vaccine development. This article proposes such a design, which has main objectives (1) to evaluate VE of each regimen versus placebo against HIV exposures occurring near the time of the immunizations; (2) to evaluate durability of VE for each vaccine regimen showing reliable evidence for positive VE; (3) to expeditiously evaluate the immune correlates of protection if any vaccine regimen shows reliable evidence for positive VE; and (4) to compare VE among the vaccine regimens. The design uses sequential monitoring for the events of vaccine harm, non-efficacy, and high efficacy, selected to weed out poor vaccines as rapidly as possible while guarding against prematurely weeding out a vaccine that does not confer efficacy until most of the immunizations are received. The evaluation of the design shows that testing multiple vaccine regimens is important for providing a well-powered assessment of the correlation of vaccine-induced immune responses with HIV infection, and is critically important for providing a reasonably powered assessment of the value of identified correlates as surrogate endpoints for HIV infection. PMID:23181167

Efficacy of rasagiline in early Parkinson's disease: a meta-analysis of data from the TEMPO and ADAGIO studies.

PubMed

Hauser, Robert A; Abler, Victor; Eyal, Eli; Eliaz, Rom E

2016-10-01

To evaluate the efficacy of rasagiline versus placebo in a pooled population of patients with early Parkinson's disease (PD). TEMPO and ADAGIO were Phase III studies that evaluated the symptomatic efficacy of rasagiline versus placebo in patients with early PD. This meta-analysis included Unified Parkinson's Disease Rating Scale (UPDRS) observations from weeks 12, 24 and 36 in ADAGIO and from weeks 14 and 26 in TEMPO; TEMPO visits were recoded to weeks 12 and 24, respectively. The present analysis includes all patients who received rasagiline 1 mg/day, 2 mg/day or placebo, and had ≥1 post-baseline observations and a subgroup of patients whose baseline UPDRS Total scores were ≥27 (Upper Quartile population). Change from baseline in UPDRS scores were evaluated using mixed models repeated measures analyses. Of the 1578 patients randomized to the two studies, 1546 patients met criteria for inclusion in the meta-analysis. Effects on UPDRS Total, motor and activities of daily living scores were significantly better for both doses of rasagiline compared with placebo at all time periods. The Upper Quartile population included 402 patients with a UPDRS Total score ≥27 at baseline. These patients generally demonstrated a larger magnitude of treatment effect than was seen in the full population. This meta-analysis confirms the efficacy of rasagiline monotherapy over 36 weeks. Although TEMPO and ADAGIO are considered studies of "very early" PD, both contained a sizeable pool of patients with more severe disease. In addition, the meta-analysis showed a larger magnitude of effect in patients with more severe baseline disease.

All APAPs Are Not Equivalent for the Treatment of Sleep Disordered Breathing: A Bench Evaluation of Eleven Commercially Available Devices

PubMed Central

Zhu, Kaixian; Roisman, Gabriel; Aouf, Sami; Escourrou, Pierre

2015-01-01

Study Objectives: This study challenged on a bench-test the efficacy of auto-titrating positive airway pressure (APAP) devices for obstructive sleep disordered breathing treatment and evaluated the accuracy of the device reports. Methods: Our bench consisted of an active lung simulator and a Starling resistor. Eleven commercially available APAP devices were evaluated on their reactions to single-type SDB sequences (obstructive apnea and hypopnea, central apnea, and snoring), and to a long general breathing scenario (5.75 h) simulating various SDB during four sleep cycles and to a short scenario (95 min) simulating one sleep cycle. Results: In the single-type sequence of 30-minute repetitive obstructive apneas, only 5 devices normalized the airflow (> 70% of baseline breathing amplitude). Similarly, normalized breathing was recorded with 8 devices only for a 20-min obstructive hypopnea sequence. Five devices increased the pressure in response to snoring. Only 4 devices maintained a constant minimum pressure when subjected to repeated central apneas with an open upper airway. In the long general breathing scenario, the pressure responses and the treatment efficacy differed among devices: only 5 devices obtained a residual obstructive AHI < 5/h. During the short general breathing scenario, only 2 devices reached the same treatment efficacy (p < 0.001), and 3 devices underestimated the AHI by > 10% (p < 0.001). The long scenario led to more consistent device reports. Conclusion: Large differences between APAP devices in the treatment efficacy and the accuracy of report were evidenced in the current study. Citation: Zhu K, Roisman G, Aouf S, Escourrou P. All APAPs are not equivalent for the treatment of sleep disordered breathing: a bench evaluation of eleven commercially available devices. J Clin Sleep Med 2015;11(7):725–734. PMID:25766708

Tooth color measurement using Chroma Meter: techniques, advantages, and disadvantages.

PubMed

Li, Yiming

2003-01-01

Tooth whitening has become a popular and routine dental procedure, and its efficacy and safety have been well documented. However, the measurement of tooth color, particularly in the evaluation of the efficacy of a system intended to enhance tooth whiteness, remains a challenge. One of the instruments used for assessing tooth color in clinical whitening studies is the Minolta Chroma Meter CR-321 (Minolta Corporation USA, Ramsey, NJ, USA). This article describes the instrument and discusses various measuring procedures and the Chroma Meter's advantages, limitations, and disadvantages. The available information indicates that, although Minolta Chroma Meter CR-321 provides quantitative and objective measurements of tooth color, it can be tedious to use with a custom alignment device. The Chroma Meter data are inconsistent with the commonly used visual instruments such as Vitapan Classical Shade Guide (Vita Zahnfabrik, Bad Säckingen, Germany), although in many cases the general trends are similar. It is also questionable whether the small area measured adequately represents the color of the whole tooth. A more critical challenge is the lack of methods for interpreting the Chroma Meter data regarding tooth color change in studies evaluating the efficacy of whitening systems. Consequently, at present the Chroma Meter data alone do not appear to be adequate for determining tooth color change in whitening research, although the quantitative measurements may be useful as supplemental or supportive data. Research is needed to develop and improve the instrument and technique for quantitative measurement of tooth color and interpretation of the data for evaluating tooth color change. This paper will help readers to understand the advantages and limitations of the Minolta Chroma Meter used for evaluating the efficacy of tooth-whitening systems so that proper judgment can be made in the interpretation of the results of clinical studies.

Safety and efficacy of combined use of 4-hydroxyanisole (mequinol) 2%/tretinoin 0.01% solution and sunscreen in solar lentigines.

PubMed

Ortonne, Jean Paul; Camacho, Francisco; Wainwright, Nicholas; Bergfelt, Louise; Westerhof, Wiete; Roseeuw, Diane

2004-10-01

The objective of this open-label, noncontrolled study was to evaluate the safety of a combination solution containing 4-hydroxyanisole (mequinol) 2%/tretinoin 0.01% (Solagé) with a sunscreen in the treatment of solar lentigines. The study included a total of 406 subjects for a treatment period up to 24 weeks. Efficacy was evaluated clinically by grading the pigmentation level of the treated areas on the face and forearms. A total of 378 subjects were included in the safety population. Of the 173 subjects with skin-related and treatment-related adverse events, severity was reported as mild in 79 subjects, moderate in 71, and severe in 23. Hypopigmentation was observed in 4 subjects and had definitively resolved in 3 of these subjects at the end of the study or after treatment had been discontinued. Halo hypopigmentation was reported in 16 subjects. No allergic reactions were observed. Efficacy evaluation was based on data for 370 subjects. A total of 325 (88%) subjects had facial target lesions almost clear to clear, and a total of 298 (81%) subjects had forearm target lesions almost clear to clear. Our study shows that the mequinol 2%/tretinoin 0.01% solution is effective, convenient, and safe in the treatment of solar lentigines.

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual.

PubMed

Ghebre, Rahel G; Jones, Lovell A; Wenzel, Jennifer A; Martin, Michelle Y; Durant, Raegan W; Ford, Jean G

2014-04-01

Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. © 2014 American Cancer Society.

State-of-the-Science of Patient Navigation as a Strategy for Enhancing Minority Clinical Trial Accrual

PubMed Central

Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.

2014-01-01

Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650

Self-efficacy strategies to improve exercise in patients with heart failure: A systematic review

PubMed Central

Rajati, Fatemeh; Sadeghi, Masoumeh; Feizi, Awat; Sharifirad, Gholamreza; Hasandokht, Tolu; Mostafavi, Firoozeh

2014-01-01

BACKGROUND Despite exercise is recommended as an adjunct to medication therapy in patients with heart failure (HF), non-adherence to exercise is a major problem. While improving self-efficacy is an effective way to increase physical activity, the evidence concerning the relationship between strategies to enhance self-efficacy and exercise among HF has not been systematically reviewed. The objective of this systematic review is to assess the effect of interventions to change the self-efficacy on exercise in patients with HF. METHODS A systematic database search was conducted for articles reporting exercise self-efficacy interventions. Databases such as PubMed, ProQuest, CINAHL, Scopus, and PsycINFO, and the Cochrane Library were searched with restrictions to the years 2000-June 2014. A search of relevant databases identified 10 studies. Published randomized controlled intervention studies focusing strategies to change self-efficacy to exercise adherence in HF were eligible for inclusion. In addition, studies that have applied self-efficacy-based interventions to improve exercise are discussed. RESULTS Limited published data exist evaluating the self-efficacy strategies to improve exercise in HF. Dominant strategies to improve patients’ self-efficacy were performance accomplishments, vicarious experience, verbal persuasion, emotional arousal. CONCLUSION Evidence from some trials supports the view that incorporating the theory of self-efficacy into the design of an exercise intervention is beneficial. Moreover, exercise interventions aimed at integrating the four strategies of exercise self-efficacy can have positive effects on confidence and the ability to initiate exercise and recover HF symptoms. Findings of this study suggest that a positive relationship exists between self-efficacy and initiating and maintaining exercise in HF, especially in the short-term period. PMID:25815022

Beyond efficacy: The full public health impact of vaccines.

PubMed

Saadatian-Elahi, Mitra; Horstick, Olaf; Breiman, Robert F; Gessner, Bradford D; Gubler, Duane J; Louis, Jacques; Parashar, Umesh D; Tapia, Roberto; Picot, Valentina; Zinsou, Jean-Antoine; Nelson, Christopher B

2016-02-24

There is an active discussion in the public health community on how to assess and incorporate, in addition to safety and measures of protective efficacy, the full public health value of preventive vaccines into the evidence-based decision-making process of vaccine licensure and recommendations for public health use. The conference "Beyond efficacy: the full public health impact of vaccines in addition to efficacy measures in trials" held in Annecy, France (June 22-24, 2015) has addressed this issue and provided recommendations on how to better capture the whole public health impact of vaccines. Using key examples, the expert group stressed that we are in the midst of a new paradigm in vaccine evaluation, where all aspects of public health value of vaccines beyond efficacy should be evaluated. To yield a wider scope of vaccine benefits, additional measures such as vaccine preventable disease incidence, overall efficacy and other outcomes such as under-five mortality or non-etiologically confirmed clinical syndromes should be assessed in addition to traditional efficacy or effectiveness measurements. Dynamic modelling and the use of probe studies should also be considered to provide additional insight to the full public health value of a vaccine. The use of burden reduction and conditional licensure of vaccines based on collection of outcome results should be considered by regulatory agencies. Copyright © 2016. Published by Elsevier Ltd.. All rights reserved.

A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris.

PubMed

Parish, Lawrence Charles; Parish, Jennifer L; Routh, Hirak B; Avakian, Edward; Olayinka, Babajide; Pappert, Eric J; Plaum, Stefan; Fleischer, Alan B; Hardas, Bhushan

2011-10-01

Naftifine HCl 2% cream (NAFT-2%) is a topical allylamine antifungal preparation under development in the U.S. The objective of this randomized, double-blind, vehicle-controlled study was to evaluate the efficacy and safety of a two-week course of once-daily NAFT-2% vs. vehicle in the treatment of Tinea cruris ("jock itch"). A total of 334 subjects with T. cruris were enrolled and randomly assigned to NAFT-2% (n=166) or vehicle (n=168), which was applied once daily for 14 days. Efficacy and safety were evaluated at week 2 (end of treatment) and week 4. Efficacy measures included complete cure, treatment effectiveness, mycological cure, clinical cure, and clinical success and were analyzed only in subjects with a positive potassium hydroxide (KOH) and dermatophyte culture at baseline (n=75, naftifine; n=71, vehicle). Safety was assessed by adverse events and changes from baseline in clinical status and laboratory studies. At week 4, 25 percent of naftifine-treated subjects achieved complete cure vs. three percent of vehicle subjects and 72 percent achieved mycological cure vs. 16 percent of vehicle treated subjects (one-sided, P<0.001). Treatment effectiveness was achieved in 60 percent of NAFT-2% subjects vs. 10 percent of vehicle subjects (one-sided, P<0.001). Clinical cure rate and clinical success rate were 33 percent and 84 percent in NAFT-2% subjects, respectively vs. 10 percent and 46 percent in vehicle subjects (both P is less than 0.001, 2-sided). Week 2 efficacy response rates in NAFT-2% subjects were all lower than at week 4 but were significantly higher than week 2 vehicle-treated counterparts (P<0.025). Treatment-related AE occurred in 11 subjects (7 NAFT-2%, 4 vehicle) during the study. The most common AE in both groups were contact dermatitis (2 NAFT-2%), pruritus (2 vehicle), and application site reaction (1 per group). NAFT-2% applied once daily for two weeks (one-half the treatment duration for naftifine 1% cream) is efficacious and safe for the treatment of T. cruris.

Clinical study of the effectiveness of the "water of the 3 sulfates" on balanitis and balanoposthitis.

PubMed

Gonzalvo, V; Polo, A; Serrallach, F; Gutiérrez, A; Peyri, E

2015-03-01

Despite scientific literature mentions the application of "water of the 3 sulfates" (copper sulphate, zinc sulphate and alum) as a treatment for acute balanitis and balanoposthitis, no clinical trials evaluating its efficacy have been found. In our study we evaluate the efficacy of this solution in acute balanitis and balanoposthitis. A double-blind randomized study was designed to compare the efficacy of "water of the 3 sulfates" (intervention) with saline solution (control) in 50 patients (30 patients and 20 patients, respectively) who suffer from acute balanitis or balanoposthitis. Exudate, erythema, oedema, burning, and itching were the clinical parameters assessed. for all clinical parameters assessed, the outcomes obtained with "water of the 3 sulfates" are higher than control, although significant differences only have been found for exudate. in our study, the "water of the 3 sulfates" is significantly more effective than saline solution for removing exudates in acute balanitis and balanoposthitis. Tolerability was excellent in both treatments. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

[Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis].

PubMed

Ershova, O B; Lesniak, O M; Belova, K Iu; Nazarova, A V; Manovitskaia, A V; Musaeva, T M; Musraev, R M; Nurlygaianov, R Z; Rozhinskaia, L Ia; Skripnikova, I A; Toroptsova, N V

2014-01-01

To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor xB ligand (RANKL), within an open-label observational study. Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases. The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.

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.

Bio-efficacy, physical integrity, community usage and washing practices of mosquito nets treated with ICON MAXX long-lasting insecticidal treatment in India

PubMed Central

Sahu, Sudhansu Sekhar; Gunasekaran, Kasinathan; Vijayakumar, Kilakootil Narayanan; Jambulingam, Purushothaman

2017-01-01

BACKGROUND New brands of potential long lasting insecticide nets (LLINs) and LLIN treatment kits require field evaluation before they are used in a vector control programme. OBJECTIVES The aim of this study was to evaluate the bio-efficacy, usage, washing practice and physical integrity of nets treated with LLIN treatment kit, ICON MAXX in a phase III field trial in Odisha state, India. METHODS A total of 300 polyester nets treated with ICON MAXX and 140 polyester nets treated conventionally with lambda-cyhalothrin CS 2.5% ITNs were distributed. The bio-efficacy was evaluated with WHO cone bioassay. The chemical analysis of netting pieces was done at the beginning, after 12 and 36 months of the trial. FINDINGS After one year of distribution of nets, the bioassay showed 100% mortality on both ITNs and ICON MAXX treated nets. At 36 months, the overall pass rate was 58.8% and the mean lambda-cyhalothrin content of LLINs was 34.5 mg ai/m2, showing a loss of 44.4% of the original concentration. CONCLUSION ICON MAXX treated LLIN was found to retain bio-efficacy causing 97% knockdown of Anopheles stephensi up to 30 months and met the WHOPES criteria. However, the desired bio-efficacy was not sustained up to 36 months. PMID:28125134

[Results of a post-marketing surveillance of meropenem for febrile neutropenia].

PubMed

Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

2015-08-01

The post-marketing surveillance of meropenem (Meropen) for febrile neutropenia (FN) was conducted between July 2010 and June 2012 to evaluate safety and efficacy under actual clinical use. There were 1191 and 1124 evaluable cases for safety and efficacy respectively, of 1207 case cards collected from 180 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 15.7% (187/1191 cases), and the main ADRs were alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hepatic function abnormal, and liver disorder, which were similar to these observed in the clinical study for FN or post marketing surveillances of meropenem conducted before. In efficacy analysis, the overall efficacy was 81.8% (919/1124 cases). Also, it was 79.2% (708/894 cases) for hematological malignancy and 91.8% (213/232 cases) for solid cancer. These results confirmed meropenem (Meropen) is one of the well-tolerated and potent antimicrobial agents for febrile neutropenia.

A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris.

PubMed

Jones, Terry M; Jarratt, Michael T; Mendez-Moguel, Ines; Paz, Nelly; Grekin, Steven K; Cognata Smith, Christina; Kaur, Mandeep

2014-01-01

Tinea cruris, a pruritic superficial fungal infection of the groin, is the second most common clinical presentation for dermatophytosis. This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris. 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments. Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle. The study was conducted under controlled conditions in a relatively small population. Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.

Treatment of mild to moderate acne with a fixed combination of hydroxypinacolone retinoate, retinol glycospheres and papain glycospheres.

PubMed

Veraldi, S; Barbareschi, M; Guanziroli, E; Bettoli, V; Minghetti, S; Capitanio, B; Sinagra, J L; Sedona, P; Schianchi, R

2015-04-01

A fixed combination of 0.1% hydroxypinacolone retinoate (synthetic esther of 9-cis-retinoic acid), 1% retinol in glycospheres and 2% papain in glycospheres in aqueous gel has been recently introduced into the Italian market in order to reduce the incidence and severity of irritant contact dermatitis caused by topical retinoids, without compromising their efficacy. Primary objectives of this sponsor-free, pilot, open, multicenter study were to evaluate the efficacy and tolerability of this gel in patients with comedonal-papular, mild to moderate acne of the face. Ninety-eight Caucasian patients (28 males and 70 females), with an age ranging from 15 to 40 years, were treated with the gel once daily for 12 weeks. Acne severity and treatment efficacy were evaluated by means of the Global Acne Grading System (GAGS) and lesions count. Ninety-four patients were considered evaluable. A 41% mean reduction in the GAGS score was observed; a 40.8% mean reduction of total lesions was recorded; 15.3% of patients experienced mild to moderate local side effects (dryness, peeling, erythema, burning). No patients stopped the treatment because of these side effects. This study, based on a high number of evaluable patients, demonstrates that this fixed combination is an effective and safe option for the treatment of comedonal-papular, mild to moderate acne of the face. A controlled clinical study is necessary to confirm these data.

Psychometric evaluation of the Marijuana Reduction Strategies Self-Efficacy Scale with young recreational marijuana users.

PubMed

Davis, Alan K; Osborn, Lawrence A; Rosenberg, Harold; Cross, Nicole; Lauritsen, Kirstin J; Ashrafioun, Lisham; Bradbury, Stacey; Feuille, Margaret; Lackey, Jennifer H; Hawley, Anna; Leith, Jaclyn

2014-12-01

This study evaluated the cue-reactivity and several psychometric properties of a questionnaire designed to assess marijuana users' self-efficacy to employ 21 specific cognitive-behavioral strategies to reduce their marijuana use. Using a web-based recruitment and data-collection procedure, 513 regular marijuana users completed dependent measures following marijuana-related or control cue exposure. Although exposure to marijuana-related stimuli significantly increased reported craving, mean reduction-strategy self-efficacy scores did not differ as a function of cue exposure. Reliability analyses supported retaining all 21 items as a single scale. Reduction-strategy self-efficacy was positively associated with marijuana-refusal self-efficacy and with recent past use of reduction strategies, was negatively associated with quantity and frequency of marijuana use and marijuana-related problems, and was positively but weakly associated with general self-efficacy. The most frequently reported strategies that were employed reflected restricting marijuana use to once per day, not keeping a large stash available, turning down unwanted hits, and not obtaining more marijuana right away if one's supply runs out. These findings further support the reliability and validity of the questionnaire when administered to a diverse sample of regular marijuana users. Copyright © 2014 Elsevier Ltd. All rights reserved.

Efficacy of treatments with toltrazuril 7.5% and lasalocid sodium in sheep naturally infected with Eimeria spp.

PubMed

Rodrigues, Fernando de Souza; Tavares, Luiz Eduardo Roland; Paiva, Fernando

2016-01-01

The objective of this study was to evaluate the efficacy of an experimental formulation of toltrazuril 7.5% + Trimix™ on a naturally acquired infection of Eimeria spp. in suckling lambs kept on pasture and, in another trial, evaluate the comparative efficacy between lasalocid and toltrazuril 7.5% + Trimix™ in newly weaned sheep under feedlot conditions that had been naturally infected with Eimeria spp. In the first experiment, 30 suckling lambs were divided into two groups: A - treated with toltrazuril 7.5% + Trimix™ and B- control. In experiment 2, 30 weaned sheep were divided into three groups: I - treated with toltrazuril 7.5% + Trimix™, II - treated with lasalocid and III - control. Treatment group A showed an efficacy of 90, 99.4 and 87.3% on days 5, 10 and 20, respectively. Treatment group I had an efficacy of 98.2, 92.6 and 94.5%, while group II had an efficacy of 72.7, 81.6 and 95.9% on days 7, 21 and 42, respectively. Eight Eimeria species were identified; E. ovinoidalis was the most common. Treatment with the toltrazuril 7.5% +Trimix ™ formulation was effective against Eimeria spp. in suckling lambs in field conditions and lambs weaned in under feedlot conditions.

Experimental Evaluation of the Training Structure of the Picture Exchange Communication System (PECS)

ERIC Educational Resources Information Center

Cummings, Anne R.; Carr, James E.; LeBlanc, Linda A.

2012-01-01

The Picture Exchange Communication System (PECS) is a picture-based alternative communication method that is widely accepted and utilized with individuals with disabilities. Although prior studies have examined the clinical efficacy of PECS, none have experimentally evaluated its manualized training structure. We experimentally evaluated the…

Transcultural self-efficacy perceptions of baccalaureate nursing students.

PubMed

Halter, Margaret; Grund, Faye; Fridline, Mark; See, Sharon; Young, Lisa; Reece, Carol

2015-05-01

Addressing the health care needs of a 21st-century nation that is experiencing increased diversity and disparity will require new models of educating future providers. The cultural competence and confidence model was the guiding framework in a study evaluating the influence of cultural educational offerings on the transcultural self-efficacy (TSE) perceptions in baccalaureate nursing students. The Transcultural Self-Efficacy Tool was used to measure perceived TSE in a pretest (N = 260), posttest (N = 236) study over an academic year. Significant changes were demonstrated in overall self-efficacy and on the cognitive, practical, and affective subscales. A classification and regression tree analysis identified social orientation as the demographic variable most predictive of the TSE level. This study supports previous research where positive changes were found in students' TSE based on the inclusion of cultural interventions in the nursing curriculum. © The Author(s) 2014.

The efficacy of palatal augmentation prostheses for speech and swallowing in patients undergoing glossectomy: a review of the literature.

PubMed

Marunick, Mark; Tselios, Nicholas

2004-01-01

This article provides a review of the literature to assist the clinician in determining the efficacy of palatal augmentation prosthesis regarding speech and swallowing for the patient undergoing glossectomy. A MEDLINE search was conducted. Peer-reviewed articles published from 1966 to July 2002 that addressed the question of the efficacy of this prosthesis to improve speech and swallowing after partial or total glossectomy were included. Studies reviewed had to incorporate an objective evaluation of one or both functions. Nine of 130 studies met the selection criteria (4 retrospective, 1 case control, and 4 case reports). A total of 50 subjects were studied, 42 for swallowing and 37 for speech. In 36/42 subjects, treatment was advantageous for swallowing and in 32/37 subjects, it was advantageous for speech. On the basis of the limited evidence available, the functional efficacy of the palatal augmentation prosthesis is supported.

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.

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.

A Feedback-Controlled Mandibular Positioner Identifies Individuals With Sleep Apnea Who Will Respond to Oral Appliance Therapy.

PubMed

Remmers, John E; Topor, Zbigniew; Grosse, Joshua; Vranjes, Nikola; Mosca, Erin V; Brant, Rollin; Bruehlmann, Sabina; Charkhandeh, Shouresh; Zareian Jahromi, Seyed Abdolali

2017-07-15

Mandibular protruding oral appliances represent a potentially important therapy for obstructive sleep apnea (OSA). However, their clinical utility is limited by a less-than-ideal efficacy rate and uncertainty regarding an efficacious mandibular position, pointing to the need for a tool to assist in delivery of the therapy. The current study assesses the ability to prospectively identify therapeutic responders and determine an efficacious mandibular position. Individuals (n = 202) with OSA participated in a blinded, 2-part investigation. A system for identifying therapeutic responders was developed in part 1 (n = 149); the predictive accuracy of this system was prospectively evaluated on a new population in part 2 (n = 53). Each participant underwent a 2-night, in-home feedback-controlled mandibular positioner (FCMP) test, followed by treatment with a custom oral appliance and an outcome study with the oral appliance in place. A machine learning classification system was trained to predict therapeutic outcome on data obtained from FCMP studies on part 1 participants. The accuracy of this trained system was then evaluated on part 2 participants by examining the agreement between prospectively predicted outcome and observed outcome. A predicted efficacious mandibular position was derived from each FCMP study. Predictive accuracy was as follows: sensitivity 85%; specificity 93%; positive predictive value 97%; and negative predictive value 72%. Of participants correctly predicted to respond to therapy, the predicted mandibular protrusive position proved efficacious in 86% of cases. An unattended, in-home FCMP test prospectively identifies individuals with OSA who will respond to oral appliance therapy and provides an efficacious mandibular position. The trial that this study reports on is registered on www.clinicaltrials.gov, ID NCT03011762, study name: Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favourable Candidates for Oral Appliance Therapy. © 2017 American Academy of Sleep Medicine

Huangqi injection (a traditional Chinese patent medicine) for chronic heart failure: a systematic review.

PubMed

Fu, Shufei; Zhang, Junhua; Menniti-Ippolito, Francesca; Gao, Xiumei; Galeotti, Francesca; Massari, Marco; Hu, Limin; Zhang, Boli; Ferrelli, Rita; Fauci, Alice; Firenzuoli, Fabio; Shang, Hongcai; Guerra, Ranieri; Raschetti, Roberto

2011-05-06

Chronic heart failure (CHF) is a global public health problem. Therefore, novel and effective drugs that show few side-effects are needed. Early literature studies indicated that Huangqi injection is one of the most commonly used traditional Chinese patent medicines for CHF in China. As a large number of clinical studies has been carried out and published, it is essential to evaluate the effectiveness and safety of Huangqi injection. Therefore, we carried out this systematic review under the support of the framework of the Joint Sino-Italian Laboratory (JoSIL). To evaluate the efficacy and safety of Huangqi injection for CHF according to the available scientific knowledge. An extensive search including PubMed, EMBASE, CBM, the Cochrane Library and Chinese literature databases was performed up to July 2008. Clinical trials regarding Huangqi injection for the treatment of CHF were searched for, irrespective of languages. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration and STATA 9.2 were used for data analysis. After selection of 1,205 articles, 62 RCTs and quasi-RCTs conducted in China and published in Chinese journals were included in the review. The methodological quality of the trials was low. In most trials inclusion and exclusion criteria were not specified. Furthermore, only one study evaluated the outcomes for drug efficacy after an adequate period of time. For these reasons and because of the different baseline characteristics we did not conduct a meta-analysis. Although available studies are not adequate to draw a conclusion on the efficacy and safety of Huangqi injection (a traditional Chinese patent medicine), we hope that our work could provide useful experience on further studies on Huangqi injections. The overall level of TCM clinical research needs to be improved so that the efficacy of TCM can be evaluated by the international community and possibly some TCM can enter into the international market.

Adult day health care evaluation study: methodology and implementation. Adult Day Health Care Evaluation Development Group.

PubMed Central

Hedrick, S C; Rothman, M L; Chapko, M; Inui, T S; Kelly, J R; Ehreth, J

1991-01-01

The Adult Day Health Care Evaluation Study was developed in response to a congressional mandate to study the medical efficacy and cost effectiveness of the Adult Day Health Care (ADHC) effort in the Department of Veterans Affairs (VA). Four sites providing ADHC in VA facilities are participating in an ongoing randomized controlled trial. Three years of developmental work prior to the study addressed methodological issues that were problematic in previous studies. This developmental work resulted in the methodological approaches described here: (1) a patient recruitment process that actively recruits and screens all potential candidates using empirically developed admission criteria based on predictors of nursing home placement in VA; (2) the selection and development of measures of medical efficacy that assess a wide range of patient and caregiver outcomes with sufficient sensitivity to detect small but clinically important changes; and (3) methods for detailed, accurate, and efficient measurement of utilization and costs of health care within and outside VA. These approaches may be helpful to other researchers and may advance the methodological sophistication of long-term care program evaluation. PMID:1991678

Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review.

PubMed

Cabarrou, B; Mourey, L; Dalenc, F; Balardy, L; Kanoun, D; Roché, H; Boher, J M; Rougé-Bugat, M E; Filleron, Thomas

2017-08-01

As the incidence of invasive breast cancer will increase with age, the number of elderly patients with a diagnosis metastatic breast cancer will also rise. But the use of cytotoxic drugs in elderly metastatic breast cancer patients is not systematic and is dreaded by medical oncologists. The need for prospective oncologic data from this population seems increasingly obvious. The main objective of this review is to investigate design and characteristics of phase II trials that assess activity and feasibility of chemotherapies in elderly advanced/metastatic breast cancer patients. An electronic search in PUBMED allowed us to retrieve articles published in English language on phase II trials in elderly metastatic breast cancer between January 2002 and May 2016. Sixteen publications were finally included in this review. The primary endpoint was a simple, a composite, and a co-primary endpoints in 11, three, and two studies, respectively. Efficacy was the primary objective in 15 studies: simple (n = 10), composite (n = 3), co-primary endpoints (n = 2). Composite or co-primary endpoints combined efficacy and toxicity. Thirteen studies used multistage designs. Only five studies evaluated the feasibility, i.e., to jointly assess efficacy and tolerance to treatment (toxicity, quality of life, etc) as primary endpoint. Development of elderly specific phase III clinical trials might be challenging, it therefore seems essential to conduct phase II clinical trials evaluating jointly efficacy and toxicity in a well-defined geriatric population. Use of multistage designs that take into account heterogeneity would allow to identify a subpopulation at interim analysis and to reduce the number of patients exposed to an inefficient or a toxic treatment regimen. It is crucial to evaluate new therapies (targeted therapies, immunotherapies) using adequate methodologies (Study design, endpoint).

Therapeutic efficacy of three hyaluronic acid formulations in young and middle-aged patients with early-stage meniscal injuries

PubMed Central

Dernek, Bahar; Kesiktas, Fatma Nur; Duymus, Tahir Mutlu; Diracoglu, Demirhan; Aksoy, Cihan

2017-01-01

[Purpose] To investigate and compare the efficacy of three hyaluronic acid formulations in patients with early-stage meniscal injuries. [Subjects and Methods] Male and female patients who were admitted to our clinic between January 2013 and December 2013, diagnosed with early-stage meniscus lesions of the knee, and given a hyaluronic acid treatment were included in this retrospective study. Patients were categorized into 3 groups according to their treatments: MONOVISC, OSTENIL PLUS, or ORTHOVISC. Scores from a Visual Analog Scale and the Western Ontario and McMaster Universities Arthritis Index were evaluated at baseline and one, three, and six months after baseline. [Results] A total of 55 patients were included in this study. Most of the patients were female (55%), and the mean age of the patients was 42.4 (± 8.1) years. Based on the pre- and post-injection data, there was significant reductions both in the Visual Analog Scale score and the Western Ontario and McMaster Universities Arthritis Index score after the injections for all groups. According to intergroup comparisons, no significant difference was observed in terms of efficacy. [Conclusion] Three hyaluronic acid formulations produced a similar efficacy in patients with meniscal injuries, and further studies are needed to evaluate long-term results. PMID:28744035

Child Adjustment and Parent Efficacy Scale-Developmental Disability (CAPES-DD): First psychometric evaluation of a new child and parenting assessment tool for children with a developmental disability.

PubMed

Emser, Theresa S; Mazzucchelli, Trevor G; Christiansen, Hanna; Sanders, Matthew R

2016-01-01

This study examined the psychometric properties of the Child Adjustment and Parent Efficacy Scale-Developmental Disability (CAPES-DD), a brief inventory for assessing emotional and behavioral problems of children with developmental disabilities aged 2- to 16-years, as well as caregivers' self-efficacy in managing these problems. A sample of 636 parents participated in the study. Children's ages ranged from 2 to 15. Exploratory and confirmatory factor analyses supported a 21-item, three-factor model of CAPES-DD child adjustment with 13 items describing behavioral (10 items) and emotional (3 items) problems and 8 items describing prosocial behavior. Three additional items were included due to their clinical usefulness and contributed to a Total Problem Score. Factor analyses also supported a 16-item, one factor model of CAPES-DD self-efficacy. Psychometric evaluation of the CAPES-DD revealed scales had satisfactory to very good internal consistency, as well as very good convergent and predictive validity. The instrument is to be in the public domain and free for practitioners and researchers to use. Potential uses of the measure and implications for future validation studies are discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

Antidepressant drugs can modify cytotoxic action of temozolomide.

PubMed

Bielecka, A M; Obuchowicz, E

2017-09-01

Cancer patients often require antidepressant treatment due to comorbid depressive disorder. However, recent studies have demonstrated that antidepressant drugs affect the efficacy of chemotherapy and promote progression of cancer. Apart from the main mood-improving effect, antidepressant drugs also produce analgesic, anxiolytic, hypnotic and pro-cognitive actions. Patients suffering from brain cancer constitute the greatest percentage of depressive cancer patients. However, vital safety and efficacy issues related to combined therapy with temozolomide, the first-line cytostatic in patients diagnosed with glioblastoma multiforme, and antidepressant drugs have yet to be addressed. The aim of the present studies was to evaluate the effect of three antidepressant drugs (imipramine, fluoxetine and tranylcypromine) on the cytotoxic efficacy of temozolomide on T98G cells, a human glioblastoma cell line. In our experiments, we used a complex experimental in vitro system to mimic the instability of a tumour's oxygen supply, thereby reproducing conditions that occur inside the tumour. The effect of the interaction between temozolomide and antidepressant drugs on viability, apoptosis and intensity of divisions of glioblastoma cells was evaluated under different oxygen conditions. The results of our studies demonstrated that imipramine and tranylcypromine reduced the cytotoxic efficacy of temozolomide under some oxygen conditions while fluoxetine did not demonstrate such effects. © 2016 John Wiley & Sons Ltd.

Cognitive rehabilitation in epilepsy: An evidence-based review.

PubMed

Farina, Elisabetta; Raglio, Alfredo; Giovagnoli, Anna Rita

2015-01-01

To review the modalities of cognitive rehabilitation (CR), outcome endpoints, and the levels of evidence of efficacy of different interventions. A systematic research in Pubmed, Psychinfo, and SCOPUS was performed assessing the articles written in the entire period covered by these databases till December 2013. Articles in English, Spanish or French were evaluated. A manual research evaluated the references of all of the articles. The experimental studies were classified according to the level of evidence of efficacy, using a standardized Italian method (SPREAD, 2007), adopting the criteria reported by Cicerone et al. (2000, 2011). Eighteen papers were classified into two reviews, four papers dealing with the principles and efficacy of CR in epilepsy, a methodological paper, a single-case report, a multiple-case report, and nine experimental papers. Most studies involved patients with temporal lobe epilepsy. Different types of CR were used to treat patients with epilepsy. A holistic rehabilitation approach was more useful than selective interventions to treat memory and attention disturbances. CR may be a useful tool to treat cognitive impairment in patients with epilepsy. However, the modalities of treatment and outcome endpoints are important concerns of clinical care and research. Controlled studies are needed to determine the efficacy of rehabilitation in well-defined groups of patients with epilepsy. Copyright © 2014 Elsevier B.V. All rights reserved.

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.

Contextualized Measurement of Self-Efficacy and College Students' Perceived Sources of Self-Efficacy in Introductory Plant Science Courses

ERIC Educational Resources Information Center

Keefe, Lisa Madalon

2013-01-01

Institutions of higher learning are recently being held more accountable for the learning outcomes of their students. As such, universities have begun to actively measure and evaluate student learning and motivational outcomes in an effort to improve the successful outcomes of their students. To support this work, two studies were conducted to…

Combined Use of Self-Efficacy Scale for Oral Health Behaviour and Oral Health Questionnaire: A Pilot Study

ERIC Educational Resources Information Center

Soutome, Sakiko; Kajiwara, Kazumi; Oho, Takahiko

2012-01-01

Objective: To examine whether the combined use of a task-specific self-efficacy scale for oral health behaviour (SEOH) and an oral health questionnaire (OHQ) would be useful for evaluating subjects' behaviours and cognitions. Design: Questionnaires. Methods: One hundred and eighty-five students completed the SEOH and OHQ. The 30-item OHQ uses a…

Efficacy of Montessori Education in Attention Gathering Skill of Children

ERIC Educational Resources Information Center

Yildirim Dogru, S. Sunay

2015-01-01

The aim of this study is to evaluate the efficacy of Montessori education which is offered to upskill the attention gathering skill of children with attention-deficit/hyperactivity disorder. In total fifteen pre-schooler participants, six girls and nine boys who are diagnosed with ADHD (7 of the children with ADHD, 8 with only AD), joined to this…

A Meta-Analytic Review of the Efficacy of Physical Exercise Interventions on Cognition in Individuals with Autism Spectrum Disorder and ADHD

ERIC Educational Resources Information Center

Tan, Beron W. Z.; Pooley, Julie A.; Speelman, Craig P.

2016-01-01

This review evaluates the efficacy of using physical exercise interventions on improving cognitive functions in individuals with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD). This review includes a meta-analysis based on a random-effects model of data reported in 22 studies with 579 participants aged…

Efficacy of supercritical carbon dioxide for nonthermal inactivation of Escherichia coli K12 in apple cider

USDA-ARS?s Scientific Manuscript database

This study evaluated the efficacy of a supercritical carbon dioxide (SCCO2) system with a gas-liquid porous metal contactor for eliminating Escherichia coli K12 in apple cider. Pasteurized, preservative-free apple cider was inoculated with E. coli K12 and processed using the SCCO2 system at CO2 conc...

Trajectories of Mentors' Perceived Self-Efficacy during an Academic Mentoring Experience: What They Look Like and What Are Their Personal and Experimental Correlates?

ERIC Educational Resources Information Center

Larose, Simon

2013-01-01

In my study, mentors matched with college mentees evaluated their self-efficacy nine times, during their participation in an academic mentoring program. Three distinct groups emerged as follows: (a) mentors who perceived themselves as moderately efficient throughout the mentoring relationship (the moderate stable (MS) group), (b) mentors who…

Academic Delay of Gratification and Self-Efficacy Enhance Academic Achievement among Minority College Students.

ERIC Educational Resources Information Center

Bembenutty, Hefer

The direct and indirect effects of academic delay of gratification and self-efficacy on academic performance of minority college students (n=45) were evaluated. The students were enrolled in an introductory writing course as part of a summer immersion program at a Midwestern university. The results of this study support the notion that delay of…

Articaine (4%) with epinephrine (1:100,000 or 1:200,000) in intraosseous injections in symptomatic irreversible pulpitis of mandibular molars: anesthetic efficacy and cardiovascular effects.

PubMed

Pereira, Leandro Augusto Pinto; Groppo, Francisco Carlos; Bergamaschi, Cristiane de Cássia; Meechan, John Gerard; Ramacciato, Juliana Cama; Motta, Rogério Heládio Lopes; Ranali, José

2013-08-01

The aim of this study was to compare the cardiovascular effects and the anesthetic efficacy of intraosseous injections of 4% articaine with 1:100,000 epinephrine (EPI100) or 4% articaine with 1:200,000 epinephrine (EPI200). In this prospective, randomized, double-blind study, 0.9 mL EPI100 and EPI200 solutions were administered for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis in 60 patients. The anesthetic success and pain during anesthesia were evaluated by visual analog scale. The cardiovascular parameters evaluated were heart rate, diastolic/systolic blood pressure, pulse oximetry, and electrocardiogram changes. Both solutions provided high anesthetic efficacy (96.8% and 93.1% for EPI100 and EPI200, respectively; P > .05), and the cardiovascular parameters showed minimal incidences of significant differences throughout the clinical procedure. The epinephrine concentration did not affect the efficacy of 4% articaine, and both solutions produced a high success level of pulpal anesthesia. Intraosseous delivery by slow speed of injection did not induce significant clinical changes in cardiovascular parameters. Copyright © 2013 Elsevier Inc. All rights reserved.

Comparison between the efficacy of ginger and sumatriptan in the ablative treatment of the common migraine.

PubMed

Maghbooli, Mehdi; Golipour, Farhad; Moghimi Esfandabadi, Alireza; Yousefi, Mehran

2014-03-01

Frequency and torment caused by migraines direct patients toward a variety of remedies. Few studies to date have proposed ginger derivates for migraine relief. This study aims to evaluate the efficacy of ginger in the ablation of common migraine attack in comparison to sumatriptan therapy. In this double-blinded randomized clinical trial, 100 patients who had acute migraine without aura were randomly allocated to receive either ginger powder or sumatriptan. Time of headache onset, its severity, time interval from headache beginning to taking drug and patient self-estimation about response for five subsequent migraine attacks were recorded by patients. Patients(,) satisfaction from treatment efficacy and their willingness to continue it was also evaluated after 1 month following intervention. Two hours after using either drug, mean headaches severity decreased significantly. Efficacy of ginger powder and sumatriptan was similar. Clinical adverse effects of ginger powder were less than sumatriptan. Patients' satisfaction and willingness to continue did not differ. The effectiveness of ginger powder in the treatment of common migraine attacks is statistically comparable to sumatriptan. Ginger also poses a better side effect profile than sumatriptan. Copyright © 2013 John Wiley & Sons, Ltd.

Evaluation of the validity of the condom use self-efficacy scale (CUSES) in young men using two behavioral simulations.

PubMed

Forsyth, A D; Carey, M P; Fuqua, R W

1997-03-01

Assessment of behavioral skills remains critical to the evaluation of HIV prevention interventions; however, investigators often rely upon participant reports of self-efficacy to estimate such skills. We evaluated the relationship between self-efficacy beliefs for condom use and behavioral performance. Forty-three men completed the Condom Use Self-Efficacy Scale (CUSES) and participated in 2 behavioral assessments. Regression analyses indicated that the CUSES subscales relevant to negotiation of condom use did not account for a significant amount of variability in interpersonal skills; similarly, the CUSES subscale relevant to technical condom use skill did not account for variability in the condom application scores. We caution investigators against the assumption that higher self-efficacy reflects behavioral competence for HIV-risk reduction.

Efficacy of mineral cationic carrier against sulphur mustard in skin decontamination.

PubMed

Vucemilović, Ante; Hadzija, Mirko; Jukić, Ivan

2008-12-01

The aim of this study was to evaluate decontamination (absorption) efficacy of a preparation called Mineral Cationic Carrier (MCC) against skin contamination with sulphur mustard in vivo. MCC is a synthetic preparation with known ion exchange, absorption efficiency, and bioactive potential. CBA mice were applied increasing doses of sulphur mustard on their skin and MCC was administered immediately after skin contamination. The results have confirmed the decontamination efficacy of MCC preparation, corresponding to 8.4 times the LD50 of percutaneous sulphur mustard, and call for further investigation.

Cognitive-behavioral therapy for body dysmorphic disorder: a review of its efficacy

PubMed Central

Prazeres, Angélica M; Nascimento, Antônio L; Fontenelle, Leonardo F

2013-01-01

The aim of this study was to review the efficacy of different methods of cognitive and/or behavioral therapies used to treat body dysmorphic disorder. We evaluated all case series, open studies, controlled trials, and meta-analyses of cognitive and/or behavioral treatment approaches to body dysmorphic disorder published up to July 2012, identified through a search in the PubMed/Medline, PsycINFO, ISI Web of Knowledge, and Scopus databases. Our findings indicate that individual and group cognitive behavioral therapies are superior to waiting list for the treatment of body dysmorphic disorder. While the efficacy of cognitive therapy is supported by one controlled trial, utility of behavioral therapy is suggested by one open study and one controlled relapse prevention follow-up study. There is a pressing need to conduct head-to-head studies, with appropriate, active, control treatment groups, in order to examine further the efficacy of cognitive and/or behavioral therapies for body dysmorphic disorder. PMID:23467711

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

PubMed

Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

2017-09-01

Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

An efficient early phase 2 procedure to screen medications for efficacy in smoking cessation.

PubMed

Perkins, Kenneth A; Lerman, Caryn

2014-01-01

Initial screening of new medications for potential efficacy (i.e., Food and Drug Administration (FDA) early phase 2), such as in aiding smoking cessation, should be efficient in identifying which drugs do, or do not, warrant more extensive (and expensive) clinical testing. This focused review outlines our research on development, evaluation, and validation of an efficient crossover procedure for sensitivity in detecting medication efficacy for smoking cessation. First-line FDA-approved medications of nicotine patch, varenicline, and bupropion were tested as model drugs, in three separate placebo-controlled studies. We also tested specificity of our procedure in identifying a drug that lacks efficacy, using modafinil. This crossover procedure showed sensitivity (increased days of abstinence) during week-long "practice" quit attempts with each of the active cessation medications (positive controls) versus placebo, but not with modafinil (negative control) versus placebo, as hypothesized. Sensitivity to medication efficacy signal was observed only in smokers high in intrinsic quit motivation (i.e., already preparing to quit soon) and not smokers low in intrinsic quit motivation, even if monetarily reinforced for abstinence (i.e., given extrinsic motivation). A crossover procedure requiring less time and fewer subjects than formal trials may provide an efficient strategy for a go/no-go decision whether to advance to subsequent phase 2 randomized clinical trials with a novel drug. Future research is needed to replicate our results and evaluate this procedure with novel compounds, identify factors that may limit its utility, and evaluate its applicability to testing efficacy of compounds for treating other forms of addiction.

A quantitative systematic review of the efficacy of mobile phone interventions to improve medication adherence.

PubMed

Park, Linda G; Howie-Esquivel, Jill; Dracup, Kathleen

2014-09-01

To evaluate the characteristics and efficacy of mobile phone interventions to improve medication adherence. Secondary aims are to explore participants' acceptability and satisfaction with mobile phone interventions and to evaluate the selected studies in terms of study rigour, impact, cost and resource feasibility, generalizability and implications for nursing practice and research. Medication non-adherence is a major global challenge. Mobile phones are the most commonly used form of technology worldwide and have the potential to promote medication adherence. Guidelines from the Centre for Reviews and Dissemination were followed for this systematic review. A comprehensive search of databases (PubMed, Web of Science, CINAHL, PsycInfo, Google Chrome and Cochrane) and bibliographies from related articles was performed from January 2002-January 2013 to identify the included studies. A quantitative systematic review without meta-analysis was conducted and the selected studies were critically evaluated to extract and summarize pertinent characteristics and outcomes. The literature search produced 29 quantitative research studies related to mobile phones and medication adherence. The studies were conducted for prevention purposes as well as management of acute and chronic illnesses. All of the studies used text messaging. Eighteen studies found significant improvement in medication adherence. While the majority of investigators found improvement in medication adherence, long-term studies characterized by rigorous research methodologies, appropriate statistical and economic analyses and the test of theory-based interventions are needed to determine the efficacy of mobile phones to influence medication adherence. © 2014 John Wiley & Sons Ltd.

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.

Role of Alexithymia, Anxiety, and Depression in Predicting Self-Efficacy in Academic Students

PubMed Central

2017-01-01

Objective. Little research is available on the predictive factors of self-efficacy in college students. The aim of the present study is to examine the role of alexithymia, anxiety, and depression in predicting self-efficacy in academic students. Design. In a cross-sectional study, a total of 133 students at Babol University of Medical Sciences (Medicine, Dentistry, and Paramedicine) participated in the study between 2014 and 2015. All participants completed the Toronto Alexithymia Scale (TAS-20), College Academic Self-Efficacy Scale (CASES), and 14 items on anxiety and depression derived from the 28 items of the General Health Questionnaire (28-GHQ). Results. Pearson correlation coefficients revealed negative significant relationships between alexithymia and the three subscales with student self-efficacy. There was no significant correlation between anxiety/depression symptoms and student self-efficacy. A backward multiple regression analysis revealed that alexithymia was a negative significant predictor of self-efficacy in academic students (B = −0.512, P < 0.001). The prevalence of alexithymia was 21.8% in students. Multiple backward logistic analysis regression revealed that number of passed semesters, gender, mother's education, father's education, and doctoral level did not accurately predict alexithymia in college students. Conclusion. As alexithymia is prevalent in college students and affects self-efficacy and academic functioning, we suggest it should be routinely evaluated by mental physicians at universities. PMID:28154839

Role of Alexithymia, Anxiety, and Depression in Predicting Self-Efficacy in Academic Students.

PubMed

Faramarzi, Mahbobeh; Khafri, Soraya

2017-01-01

Objective . Little research is available on the predictive factors of self-efficacy in college students. The aim of the present study is to examine the role of alexithymia, anxiety, and depression in predicting self-efficacy in academic students. Design . In a cross-sectional study, a total of 133 students at Babol University of Medical Sciences (Medicine, Dentistry, and Paramedicine) participated in the study between 2014 and 2015. All participants completed the Toronto Alexithymia Scale (TAS-20), College Academic Self-Efficacy Scale (CASES), and 14 items on anxiety and depression derived from the 28 items of the General Health Questionnaire (28-GHQ). Results . Pearson correlation coefficients revealed negative significant relationships between alexithymia and the three subscales with student self-efficacy. There was no significant correlation between anxiety/depression symptoms and student self-efficacy. A backward multiple regression analysis revealed that alexithymia was a negative significant predictor of self-efficacy in academic students ( B = -0.512, P < 0.001). The prevalence of alexithymia was 21.8% in students. Multiple backward logistic analysis regression revealed that number of passed semesters, gender, mother's education, father's education, and doctoral level did not accurately predict alexithymia in college students. Conclusion . As alexithymia is prevalent in college students and affects self-efficacy and academic functioning, we suggest it should be routinely evaluated by mental physicians at universities.

Cysticidal Efficacy of Combined Treatment With Praziquantel and Albendazole for Parenchymal Brain Cysticercosis.

PubMed

Garcia, Hector H; Lescano, Andres G; Gonzales, Isidro; Bustos, Javier A; Pretell, E Javier; Horton, John; Saavedra, Herbert; Gonzalez, Armando E; Gilman, Robert H

2016-06-01

The efficacy of current antiparasitic treatment for cerebral Taenia solium cysticercosis with either albendazole (ABZ) or praziquantel (PZQ) is suboptimal. A recent study demonstrated that combining these 2 antiparasitic drugs improves antiparasitic efficacy. We present here the parasiticidal efficacy data obtained during a previous phase II pharmacokinetic study that compared combined ABZ plus PZQ with ABZ alone. The study was a randomized, double-blinded, placebo-controlled phase II evaluation of the pharmacokinetics of ABZ (15 mg/k/d, for 10 days) and PZQ (50 mg/k/d, for 10 days) in intraparenchymal brain cysticercosis. Patients received the usual concomitant medications, including an antiepileptic drug (phenytoin or carbamazepine), dexamethasone, and ranitidine. Randomization was stratified by antiepileptic drug. Patients underwent safety laboratory evaluations at days 4, 7, and 11, as well as magnetic resonance (MR) imaging at 6 months to assess parasiticidal efficacy. Thirty-two patients were included, 16 in each arm. All of them completed antiparasitic treatment and underwent follow-up brain MR imaging. Cysticidal efficacy was strikingly higher in the combined ABZ-plus-PZQ group than in the ABZ-alone group (proportion of cysts resolved, 78 of 82 [95%] vs 23 of 77 [30%] [relative risk {RR}, 3.18; 95% confidence interval {CI}, 2.08-4.88; P < .001]; patients with complete cyst clearance, 12 of 16 [75%] vs 4 of 16 [25%] [RR, 3.00; 95% CI, 1.23-7.34; P = .005]). The combination of ABZ plus PZQ is more effective in destroying viable brain cysticercosis cysts than ABZ alone. NCT00441285. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

"Volunteering by chance" to promote civic responsibility and civic engagement: does it work?

PubMed

Santinello, Massimo; Cristini, Francesca; Vieno, Alessio; Scacchi, Luca

2012-01-01

This study investigated the effectiveness of a program to promote civic responsibility and prevent antisocial behavior in a sample of Italian adolescents. Participants were 83 Italian male adolescents, attending the second year of high school (Mean age = 15.79; SD = 0.87). In order to test the efficacy of different strategies (in-classroom training and service activity in a voluntary organization) we divided students into two experimental groups--one classroom of students participated in both strategies (training + volunteering group) and another classroom only participated in the training (training only group)--and one control group. Process and efficacy evaluations were completed. Data were collected before and following the intervention. The process evaluation revealed that the program was highly accepted and appreciated by students. The efficacy evaluation revealed no intervention effects on civic responsibility. However, the training + volunteering group reported a significant decrease in antisocial behavior after the program. Thus, the program was effective in preventing antisocial behavior but not in promoting civic responsibility in our sample.

Preclinical Evaluation of Efficacy and Safety of an Improved Lentiviral Vector for the Treatment of β-Thalassemia and Sickle Cell Disease

PubMed Central

Negre, Olivier; Bartholomae, Cynthia; Beuzard, Yves; Cavazzana, Marina; Christiansen, Lauryn; Courne, Céline; Deichmann, Annette; Denaro, Maria; de Dreuzy, Edouard; Finer, Mitchell; Fronza, Raffaele; Gillet-Legrand, Béatrix; Joubert, Christophe; Kutner, Robert; Leboulch, Philippe; Maouche, Leïla; Paulard, Anaïs; Pierciey, Francis J.; Rothe, Michael; Ryu, Byoung; Schmidt, Manfred; von Kalle, Christof; Payen, Emmanuel; Veres, Gabor

2015-01-01

A previously published clinical trial demonstrated the benefit of autologous CD34+ cells transduced with a self-inactivating lentiviral vector (HPV569) containing an engineered β-globin gene (βA-T87Q-globin) in a subject with β-thalassemia major. This vector has been modified to increase transduction efficacy without compromising safety. In vitro analyses indicated that the changes resulted in both increased vector titers (3 to 4 fold) and increased transduction efficacy (2 to 3 fold). An in vivo study in which 58 β-thalassemic mice were transplanted with vector- or mock-transduced syngenic bone marrow cells indicated sustained therapeutic efficacy. Secondary transplantations involving 108 recipients were performed to evaluate long-term safety. The six month study showed no hematological or biochemical toxicity. Integration site (IS) profile revealed an oligo/polyclonal hematopoietic reconstitution in the primary transplants and reduced clonality in secondary transplants. Tumor cells were detected in the secondary transplant mice in all treatment groups (including the control group), without statistical differences in the tumor incidence. Immunohistochemistry and quantitative PCR demonstrated that tumor cells were not derived from transduced donor cells. This comprehensive efficacy and safety data provided the basis for initiating two clinical trials with this second generation vector (BB305) in Europe and in the USA in patients with β-thalassemia major and sickle cell disease. PMID:25429463

Tenofovir-based Pre-Exposure Prophylaxis for HIV Prevention: Evidence and evolving questions

PubMed Central

Celum, Connie; Baeten, Jared

2012-01-01

Purpose of review Topical tenofovir gel and oral tenofovir and emtricitabine/tenofovir (FTC/TDF) have been demonstrated to have efficacy in preventing HIV-1 in some populations. Pre-exposure prophylaxis (PrEP) trials and future directions are summarized. Recent findings Peri-coital use of 1% tenofovir gel in CAPRISA 004 reduced HIV-1 acquisition by 39% and HSV-2 acquisition by 51%. Daily oral FTC/TDF demonstrated 44% reduction in HIV-1 acquisition among men who have sex with men (MSM) in iPrEx. Both studies showed higher efficacy among those with higher adherence. Efficacy of daily oral TDF and FTC/TDF was 66% and 73%, respectively, among HIV-1 uninfected partners in an HIV-1 serodiscordant partnership in the Partners PrEP Study. Efficacy of daily oral FTC/TDF was 66% in young heterosexuals in Botswana in the TDF-2 trial. The FEM-PrEP and VOICE studies in African women found no efficacy with oral FTC/TDF and TDF, respectively. Safety and tolerability were excellent and limited resistance was observed in seroconverters. Summary Topical tenofovir gel showed efficacy in African women and daily oral TDF and FTC/TDF were efficacious in MSM, and African HIV-1 serodiscordant couples and young heterosexuals. The reasons for lack of efficacy of oral FTC/TDF and TDF in two studies in African women are being investigated. Longer-acting formulations, invtravaginal rings, and new candidate antiretrovirals are being evaluated. PMID:22156901

[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 an Intervention to Promote Self-Efficacy on Quality of Life of Patients with Nasopharyngeal Carcinoma of the Zhuang Tribe Minority in Guangxi, China: A Prospective Study

PubMed Central

Lu, Jiamei; Zeng, Xiaofen; Liao, Jinlian; Zhang, Yong; Yang, Li; Li, Yuming; Lv, Jun

2017-01-01

Background Nasopharyngeal carcinoma (NPC) is endemic in China and patient self-management is poor. Minorities may suffer from psychological problems during treatments for NPC. This study aimed to implement an intervention to promote self-efficacy of minority patients (Zhuang tribe, Guangxi, China) with NPC to improve their quality of life (QOL). Material/Methods This was a prospective study of 120 patients with NPC treated at the First Affiliated Hospital of Guangxi Medical University (Guangxi, China), randomized to conventional care (n=60, controls) or conventional care plus self-efficacy interventions based on health education, behavior therapy, and psychological intervention (n=60, self-efficacy group). Self-efficacy was evaluated using the general self-efficacy scale, and QOL using the EORTC QLQ-C30. The questionnaires were completed at discharge, at 6 months, and at 1 and 2 years. The primary outcome was QOL. Results There was no difference in QOL at baseline. From study start to hospital discharge, overall QOL scores decreased in both groups, but this decrease was more important in the control group (controls: −39.31 vs. self-efficacy: −27.04, P<0.05). After discharge, each functional field QOL scores and overall QOL increased with time in the 2 groups, and they were significantly higher in the self-efficacy group. Conclusions This intervention promoting self-efficacy could increase patients’ own potential and initiative, enhance their confidence and ability to solve health problems, improve their coping with adverse effects of treatments, and have positive effects on their QOL. Self-efficacy theory-based interventions could be worth popularization during the treatment and recovery of minority patients with NPC. PMID:28832557

Comparison of Individual and Pooled Stool Samples for the Assessment of Soil-Transmitted Helminth Infection Intensity and Drug Efficacy

PubMed Central

Mekonnen, Zeleke; Meka, Selima; Ayana, Mio; Bogers, Johannes; Vercruysse, Jozef; Levecke, Bruno

2013-01-01

Background In veterinary parasitology samples are often pooled for a rapid assessment of infection intensity and drug efficacy. Currently, studies evaluating this strategy in large-scale drug administration programs to control human soil-transmitted helminths (STHs; Ascaris lumbricoides, Trichuris trichiura, and hookworm), are absent. Therefore, we developed and evaluated a pooling strategy to assess intensity of STH infections and drug efficacy. Methods/Principal Findings Stool samples from 840 children attending 14 primary schools in Jimma, Ethiopia were pooled (pool sizes of 10, 20, and 60) to evaluate the infection intensity of STHs. In addition, the efficacy of a single dose of mebendazole (500 mg) in terms of fecal egg count reduction (FECR; synonym of egg reduction rate) was evaluated in 600 children from two of these schools. Individual and pooled samples were examined with the McMaster egg counting method. For each of the three STHs, we found a significant positive correlation between mean fecal egg counts (FECs) of individual stool samples and FEC of pooled stool samples, ranging from 0.62 to 0.98. Only for A. lumbricoides was any significant difference in mean FEC of the individual and pooled samples found. For this STH species, pools of 60 samples resulted in significantly higher FECs. FECR for the different number of samples pooled was comparable in all pool sizes, except for hookworm. For this parasite, pools of 10 and 60 samples provided significantly higher FECR results. Conclusion/Significance This study highlights that pooling stool samples holds promise as a strategy for rapidly assessing infection intensity and efficacy of administered drugs in programs to control human STHs. However, further research is required to determine when and how pooling of stool samples can be cost-effectively applied along a control program, and to verify whether this approach is also applicable to other NTDs. PMID:23696905

Application of water-assisted ultraviolet light processing on the inactivation of murine norovirus on blueberries.

PubMed

Liu, Chuhan; Li, Xinhui; Chen, Haiqiang

2015-12-02

In this study, a novel set-up using water-assisted UV processing was developed and evaluated for its decontamination efficacy against murine norovirus (MNV-1) inoculated on fresh blueberries for both small and large-scale experimental setups. Blueberries were skin-inoculated with MNV-1 and treated for 1-5 min with UV directly (dry UV) or immersed in agitated water during UV treatment (water-assisted UV). The effect of the presence of 2% (v/v) blueberry juice or 5% crushed blueberries (w/w) in wash water was also evaluated. Results showed that water-assisted UV treatment generally showed higher efficacies than dry UV treatment. With 12,000 J/m(2) UV treatment in small-scale setup, MNV reductions of >4.32- and 2.48-log were achieved by water-assisted UV and dry UV treatments, respectively. Water-assisted UV showed similar inactivating efficacy as 10-ppm chlorine wash. No virus was detected in wash water after UV treatment or chlorine wash. MNV-1 was more easily killed on skin-inoculated blueberries compared with calyx-inoculated berries. When clear water was used as wash water in the large-scale setup, water-assisted UV treatment (UV dose of 12,000 J/m(2)) resulted in >3.20 log and 1.81 log MNV-1 reductions for skin- and calyx-inoculated berries, respectively. The presence of 2% blueberry juice in wash water decreased the decontamination efficacy of water-assisted UV and chlorine washing treatments. To improve the inactivation efficacy, the effect of combining water-assisted UV treatment with chlorine washing was also evaluated. The combined treatment had better or similar inactivation efficacy compared to water-assisted UV treatment and chlorine washing alone. Findings of this study suggest that water-assisted UV treatment could be used as an alternative to chlorine washing for blueberries and potentially for other fresh produce. Copyright © 2015 Elsevier B.V. All rights reserved.

A comparative multicenter study of two transdermal estradiol replacement therapies in the treatment of postmenopausal symptoms.

PubMed

Van Leusden, H A; Albertyn, G; Verlaine, C; Van Ruymbeke, J

1993-01-01

Comparison of the effects of treatment of two transdermal therapeutic systems for estrogen replacement therapy with regard to efficacy, tolerability, and acceptance. Open randomized. Multicenter. A study population of 104 postmenopausal women was randomized on a 1:1 basis to treatment with one of two estradiol patches, System (Cilag) and Estraderm (Ciba-Geigy). Systolic and diastolic BP, hot flushes, night sweating, fatigue, insomnia, depression, nervousness, headache, vaginal discomfort (efficacy variables); bleeding, dermatological symptoms, comfort and adhesiveness of patch, and other possible causes of discontinuation (tolerability); general evaluation by patient (acceptance). Considering all efficacy variables, 53% of Systen and 46% of Estraderm patients found the therapy satisfactory. Tolerability was somewhat higher in the Systen group. Adhesiveness of the patch was significantly better for Systen. Overall, 79% of Systen patients and 62% of Estraderm patients evaluated treatment as "good" or "very good." The majority of patients in both groups found the patch very comfortable or only slightly obtrusive.

Combined treatment with oral finasteride and topical minoxidil in male androgenetic alopecia: a randomized and comparative study in Chinese patients.

PubMed

Hu, Ruiming; Xu, Feng; Sheng, Youyu; Qi, Sisi; Han, Yumei; Miao, Ying; Rui, Wenlong; Yang, Qinping

2015-01-01

Finasteride at 1 mg/day and 5% topical minoxidil are effective in male androgenetic alopecia (MAGA). However, studies describing their effects in Chinese individuals are scarce. 450 Chinese MAGA patients were randomly assigned to receive finasteride (n = 160), minoxidil (n = 130) and combined medication (n = 160) for 12 months. The patients returned to the clinic every 3 months for efficacy evaluation. And efficacy was evaluated in 428 men at treatment end, including 154, 122, and 152 in the finasteride, 5% minoxidil, and combination groups, respectively. All groups showed similar baseline characteristics, including age at enrollment, and duration and severity of alopecia (p > 0.05). At 12 months, 80.5, 59, and 94.1% men treated with finasteride, 5% minoxidil and the combination therapy showed improvement, respectively. Adverse reactions were rare (finasteride, 1.8%; minoxidil, 6.1%), and disappeared right after drug withdrawal. In conclusion, finasteride is superior to 5% minoxidil, while the combined medication showed the best efficacy. © 2015 Wiley Periodicals, Inc.

Formulation Development and Evaluation of the Therapeutic Efficacy of Brinzolamide Containing Nanoemulsions

PubMed Central

Mahboobian, Mohammad Mehdi; Seyfoddin, Ali; Rupenthal, Ilva D.; Aboofazeli, Reza; Foroutan, Seyed Mohsen

2017-01-01

Brinzolamide (BZ) is an intraocular pressure reducing agent with low bioavailability. The purpose of the present study was to overcome this issue by development of BZ containing nanoemulsions (NEs) as an ocular drug delivery system with desirable therapeutic efficacy. Brinzolamide NEs were prepared by the spontaneous emulsification method. Based on initial release studies, twelve formulations with the slowest release characteristics were subjected to further physicochemical investigations such as particle size, polydispersity index, pH, refractive index, osmolality and viscosity. The therapeutic efficacy of these formulations was assessed by measuring the intraocular pressure after instillation of the prepared NEs in normotensive albino rabbit eyes. Nanoemulsions with suitable physicochemical properties exhibited high formulation stability under different conditions. more over biological evaluations indicated that using lower drug concentrations in NE formulations (0.4%) had a similar or even better pharmacodynamic effect compared to the commercial suspension with a higher drug concentration (1%). Our findings suggest that NEs could be effectively used as carriers for enhancing the bioavailability of topically applied ophthalmic drugs. PMID:29201076

Evaluation of the efficacy of emodepside+praziquantel topical solution against cestode (Dipylidium caninum, Taenia taeniaeformis, and Echinococcus multilocularis) infections in cats.

PubMed

Charles, S D; Altreuther, G; Reinemeyer, C R; Buch, J; Settje, T; Cruthers, L; Kok, D J; Bowman, D D; Kazacos, K R; Jenkins, D J; Schein, E

2005-10-01

Emodepside+praziquantel topical solution was developed to provide broad-spectrum anthelmintic activity against gastrointestinal parasites in cats. Eight controlled studies were conducted to evaluate the efficacy of a topical solution of emodepside (3 mg/kg) and praziquantel (12 mg/kg) (Profender, BayerAG, Leverkusen, Germany) against feline infections with three species of cestodes. Studies featured naturally acquired infections of Dipylidium caninum or Taenia taeniaeformis, or experimental infections with Echinococcus multilocularis that were placebo-controlled, randomized and blinded. Cats were euthanatized and necropsied between 2 and 11 days after treatment, depending on the target parasite. The efficacy of emodepside+praziquantel topical solution was 100% against D. caninum and T. taeniaeformis, and 98.5- 100% against E. multilocularis. No significant systemic or local adverse reactions to treatment were noted in cats that received the combination. Topical treatment of cats with emodepside+praziquantel topical solution was safe and highly effective against cestode infections.

Pilot of the Chronic Disease Self-Management Program for Adolescents and Young Adults With Sickle Cell Disease.

PubMed

Crosby, Lori E; Joffe, Naomi E; Peugh, James; Ware, Russell E; Britto, Maria T

2017-01-01

This study evaluated the feasibility of a group self-management intervention, the well-established Stanford Chronic Disease Self-Management Program (CDSMP), for adolescents and young adults (AYA) with sickle cell disease (SCD). A total of 22 AYA participants with SCD, ages 16-24 years, completed self-efficacy and quality of life measures before the CDSMP, after, and 3 and 6 months later. This AYA cohort showed significant improvements in self-efficacy (primary outcome) after the intervention. Analyses of follow-up data revealed a medium effect of the CDSMP on patient activation 3 months post although this was not sustained. Participants were highly satisfied, but only 64% completed the program. This study demonstrates that the CDSMP is acceptable and has the ability to improve self-efficacy. Additional research is needed to determine feasibility and evaluate health outcomes for AYA with SCD. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea.

PubMed

Park, Sang Hyoung; Kim, Young-Ho; Lee, Ji Hyun; Kwon, Hyeok Jin; Lee, Suck-Ho; Park, Dong Il; Kim, Hyung Kil; Cheon, Jae Hee; Im, Jong Pil; Kim, You Sun; Lee, Sung Young; Lee, Sang Joon

2015-01-01

To evaluate the safety and efficacy of CT-P13 (Remsima(®)) in patients with inflammatory bowel disease (IBD) in South Korea. This post-marketing study included patients with active moderate-to-severe Crohn's disease (CD), fistulizing CD (FCD), or moderate-to-severe ulcerative colitis (UC) treated with CT-P13 and followed for 30 weeks. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission. No unexpected TEAEs were observed in the 173 patients recruited to date. TEAEs occurred in 18.1, 16.7, and 26.9% of CD, FCD, and UC patients, respectively. Treatment-related TEAEs occurred in 10% of patients and were mostly mild-moderate in severity. There were five serious TEAEs (two infusion-related reactions, two infections, one abdominal pain) and no cases of malignancy, pneumonia, or death. Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not. CT-P13 was well tolerated and efficacious in patients with IBD.

The efficacy and safety of alectinib in the treatment of ALK+ NSCLC: a systematic review and meta-analysis

PubMed Central

Chen, Yuqing; Qian, Ruolan; Liu, Sihan; You, Danming; Zhang, Jian; Luo, Peng

2018-01-01

Background Alectinib is a second-generation anaplastic lymphoma kinase (ALK) inhibitor approved by the US Food and Drug Administration to treat crizotinib-refractory non-small cell lung cancer. We performed this meta-analysis to synthesize the results of different clinical trials to evaluate the efficacy and safety of alectinib. Methods A search of 3 databases, including PubMed, Web of Science, and the Cochrane Library, was performed from the inception of each database through September 5, 2017. We have pooled the overall response rate (ORR), disease control rate, progression-free survival, and intracranial ORR to evaluate the efficacy of alectinib. Discontinuation rate, rate of dose reduction or interruption due to adverse events as well as the incidence of several adverse events were aggregated to evaluate its safety. Results A total of 8 studies with 626 patients have been included in our study. The pooled efficacy parameters are as follows: ORR 70% (95% CI: 57% to 82%), disease control rate 88% (95% CI: 82% to 94%), progression-free survival 9.36 months (95% CI: 7.38% to 11.34%), and intracranial ORR 52% (95% CI: 45% to 59%). ALK inhibitor-naïve patients tend to have better responses than crizotinib-pretreated patients. The aggregate discontinuation rate is 7% (95% CI: 4% to 10%), and the pooled rate of dose reduction or interruption is 33% (95% CI: 24% to 42%). The incidences of most adverse events were relatively low, while the incidences of 2 frequently reported adverse events, myalgia (18%) and anemia (25%), were even higher than with the first-generation ALK inhibitor crizotinib. Conclusion Generally, alectinib is a drug with preferable efficacy and tolerable adverse effects, and it is suitable for the treatment of intracranial metastases. PMID:29535535

The efficacy and safety of alectinib in the treatment of ALK+ NSCLC: a systematic review and meta-analysis.

PubMed

Fan, Junsheng; Xia, Zengfei; Zhang, Xiaoli; Chen, Yuqing; Qian, Ruolan; Liu, Sihan; You, Danming; Zhang, Jian; Luo, Peng

2018-01-01

Alectinib is a second-generation anaplastic lymphoma kinase (ALK) inhibitor approved by the US Food and Drug Administration to treat crizotinib-refractory non-small cell lung cancer. We performed this meta-analysis to synthesize the results of different clinical trials to evaluate the efficacy and safety of alectinib. A search of 3 databases, including PubMed, Web of Science, and the Cochrane Library, was performed from the inception of each database through September 5, 2017. We have pooled the overall response rate (ORR), disease control rate, progression-free survival, and intracranial ORR to evaluate the efficacy of alectinib. Discontinuation rate, rate of dose reduction or interruption due to adverse events as well as the incidence of several adverse events were aggregated to evaluate its safety. A total of 8 studies with 626 patients have been included in our study. The pooled efficacy parameters are as follows: ORR 70% (95% CI: 57% to 82%), disease control rate 88% (95% CI: 82% to 94%), progression-free survival 9.36 months (95% CI: 7.38% to 11.34%), and intracranial ORR 52% (95% CI: 45% to 59%). ALK inhibitor-naïve patients tend to have better responses than crizotinib-pretreated patients. The aggregate discontinuation rate is 7% (95% CI: 4% to 10%), and the pooled rate of dose reduction or interruption is 33% (95% CI: 24% to 42%). The incidences of most adverse events were relatively low, while the incidences of 2 frequently reported adverse events, myalgia (18%) and anemia (25%), were even higher than with the first-generation ALK inhibitor crizotinib. Generally, alectinib is a drug with preferable efficacy and tolerable adverse effects, and it is suitable for the treatment of intracranial metastases.

Efficacy, effectiveness and cost-effectiveness of acupuncture for allergic rhinitis - An overview about previous and ongoing studies.

PubMed

Witt, C M; Brinkhaus, B

2010-10-28

In general, allergic rhinitis can be divided into seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). In the following sections a summary of efficacy and effectiveness studies is presented. For this narrative review we selected studies based on the following parameters: publication in English, sample size ≥30 patients, and at least 6 acupuncture sessions. Most studies aimed to evaluate the specific effects of acupuncture treatment. Only one study evaluated effectiveness and cost-effectiveness of additional acupuncture treatment. The studies which compared acupuncture with sham acupuncture always used a penetrating sham control. A medication control group was used in only two studies and one study combined acupuncture and Chinese herbal medicine. This overview shows that the trials on efficacy and on effectiveness of acupuncture are very heterogeneous. Although penetrating sham controls were used predominantly, these also varied from superficial penetration at acupuncture points to superficial insertion at non-acupuncture points. Although there is some evidence that acupuncture as additional treatment is beneficial and relatively cost-effective, there is insufficient evidence for an acupuncture specific effect in SAR. In contrast, there is some evidence that acupuncture might have specific effects in patients with PAR. However, all of the published efficacy studies are small and conclusions should be made with care. Further studies with a larger sample size are urgently needed to draw more rigorous conclusions and the results of the ongoing trials will provide us with further information within the next two years. Copyright © 2010 Elsevier B.V. All rights reserved.

Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.

PubMed

Jarratt, Michael; Jones, Terry; Adelglass, Jeffrey; Bucko, Alicia; Pollak, Richard; Roman-Miranda, Amaury; Olin, Jason T; Swinyer, Leonard

2014-07-01

Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis. This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis. A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (i.e., days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments. Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P< 0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle. This study was conducted in a relatively small population under controlled clinical trial conditions. Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.

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.

Development of an Aotus nancymaae Model for Shigella Vaccine Immunogenicity and Efficacy Studies

PubMed Central

Gregory, Michael; Lugo-Roman, Luis A.; Galvez Carrillo, Hugo; Tilley, Drake Hamilton; Baldeviano, Christian; Simons, Mark P.; Reynolds, Nathanael D.; Ranallo, Ryan T.; Suvarnapunya, Akamol E.; Venkatesan, Malabi M.; Oaks, Edwin V.

2014-01-01

Several animal models exist to evaluate the immunogenicity and protective efficacy of candidate Shigella vaccines. The two most widely used nonprimate models for vaccine development include a murine pulmonary challenge model and a guinea pig keratoconjunctivitis model. Nonhuman primate models exhibit clinical features and gross and microscopic colonic lesions that mimic those induced in human shigellosis. Challenge models for enterotoxigenic Escherichia coli (ETEC) and Campylobacter spp. have been successfully developed with Aotus nancymaae, and the addition of a Shigella-Aotus challenge model would facilitate the testing of combination vaccines. A series of experiments were designed to identify the dose of Shigella flexneri 2a strain 2457T that induces an attack rate of 75% in the Aotus monkey. After primary challenge, the dose required to induce an attack rate of 75% was calculated to be 1 × 1011 CFU. Shigella-specific immune responses were low after primary challenge and subsequently boosted upon rechallenge. However, preexisting immunity derived from the primary challenge was insufficient to protect against the homologous Shigella serotype. A successive study in A. nancymaae evaluated the ability of multiple oral immunizations with live-attenuated Shigella vaccine strain SC602 to protect against challenge. After three oral immunizations, animals were challenged with S. flexneri 2a 2457T. A 70% attack rate was demonstrated in control animals, whereas animals immunized with vaccine strain SC602 were protected from challenge (efficacy of 80%; P = 0.05). The overall study results indicate that the Shigella-Aotus nancymaae challenge model may be a valuable tool for evaluating vaccine efficacy and investigating immune correlates of protection. PMID:24595138

EFFICACY OF TACROLIMUS FOR INDUCTION OF REMISSION IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS: A SYSTEMATIC REVIEW AND META-ANALYSIS.

PubMed

Lasa, Juan; Olivera, Pablo

2017-01-01

There is evidence that shows that calcineurin inhibitors may be useful for the treatment of severe ulcerative colitis. However, evidence regarding the efficacy of tacrolimus for remission induction in this setting is scarce. To develop a systematic review on the existing evidence regarding the clinical efficacy of tacrolimus for the induction of remission in patients with moderate-to-severe ulcerative colitis. A literature search was undertaken from 1966 to August 2016 using MEDLINE, Embase, LILACS and the Cochrane Library. The following MeSH terms were used: "Inflammatory Bowel Diseases" or "Ulcerative Colitis" and "Calcineurin Inhibitors" or "Tacrolimus" or "FK506". Studies performed in adult ulcerative colitis patients that evaluated the clinical efficacy of tacrolimus for the induction of remission were considered for revision. A meta-analysis was performed with those included studies that were also placebo-controlled and randomized. Clinical response as well as clinical remission and mucosal healing were evaluated. Overall, 755 references were identified, from which 22 studies were finally included. Only two of them were randomized, placebo-controlled trials. A total of 172 patients were evaluated. A significantly lower risk of failure in clinical response was found for tacrolimus versus placebo [RR 0.58 (0.45-0.73)]; moreover, a lower risk of failure in the induction of remission was also found versus placebo [RR 0.91 (0.82-1)]. Tacrolimus seems to be a valid therapeutic alternative for the induction of remission in patients with moderate-to-severe ulcerative colitis.

Using Multiple Assessments to Evaluate Medical Students' Clinical Ability in Psychiatric Clerkships

ERIC Educational Resources Information Center

Wang, Peng-Wei; Cheng, Cheng-Chung; Chou, Frank Huang-Chih; Tsang, Hin-Yeung; Chang, Yu-San; Huang, Mei-Feng; Yen, Cheng-Fang

2011-01-01

Background: No single assessment method can successfully evaluate the clinical ability of medical students in psychiatric clerkships; however, few studies have examined the efficacy of multiple assessments, especially in psychiatry. The aim of this study was to examine the relationship among different types of assessments of medical students'…

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.

Measurement properties of instruments evaluating self-care and related concepts in people with chronic obstructive pulmonary disease: A systematic review.

PubMed

Clari, Marco; Matarese, Maria; Alvaro, Rosaria; Piredda, Michela; De Marinis, Maria Grazia

2016-01-01

The use of valid and reliable instruments for assessing self-care is crucial for the evaluation of chronic obstructive pulmonary disease (COPD) management programs. The aim of this review is to evaluate the measurement properties and theoretical foundations of instruments for assessing self-care and related concepts in people with COPD. A systematic review was conducted of articles describing the development and validation of self-care instruments. The methodological quality of the measurement properties was assessed using the COSMIN checklist. Ten studies were included evaluating five instruments: three for assessing self-care and self-management and two for assessing self-efficacy. The COPD Self-Efficacy Scale was the most studied instrument, but due to poor study methodological quality, evidence about its measurement properties is inconclusive. Evidence from the COPD Self-Management Scale is more promising, but only one study tested its properties. Due to inconclusive evidence of their measurement properties, no instrument can be recommended for clinical use. Copyright © 2016 Elsevier Inc. All rights reserved.

Intraoperative double-J stent insertion in children with scintigraphic impaired renal function and obstructive urinary tract malformation.

PubMed

Erculiani, E; Zampieri, N; Cecchetto, M; Camoglio, F S; Giacomello, L

2008-03-01

Ureteral double-J (DJ) stents are frequently used in modern urologic practice. At present the role of stents in urological and surgical practice and their efficacy in paediatric age are not yet clear. The aim of this study is to evaluate advantages and efficacy of ureteral stents, correlating clinical and radiological data with the permanence of stent in situ. Between July 1999 and July 2004 surgery with ureteral stenting was performed on 24 consecutive patients aged between 2 and 13.5 months with scintigraphic impaired renal function due to an obstructive urinary tract malformation. During the study the performance and the efficacy of indwelling stent have been evaluated through clinical and radiological variables: pre-, intra-, and post stenting blood tests, ultrasonographic and scintigraphic parameters were also evaluated. The stent insertion was useful to improve renal parenchymal thickness and renal growth. No correlation was found between improved blood tests and scintigraphic values. The improvements of clinical and radiological data were strictly correlated with the time of stenting (>3 months). The insertion of DJ stents as long-term internal urinary diversion is useful and safe. Late complications related to the use of stents are not frequent.

Sensor-augmented pump therapy in very young children with type 1 diabetes: an efficacy and feasibility observational study.

PubMed

Frontino, Giulio; Bonfanti, Riccardo; Scaramuzza, Andrea; Rabbone, Ivana; Meschi, Franco; Rigamonti, Andrea; Battaglino, Roseila; Favalli, Valeria; Bonura, Clara; Sicignano, Sabrina; Gioia, Elisa; Zuccotti, Gian Vincenzo; Cerutti, Franco; Chiumello, Giuseppe

2012-09-01

Efficacy and feasibility of sensor-augmented pump (SAP) therapy were evaluated in very young children with type 1 diabetes (T1D). SAP (Dexcom [San Diego, CA] Seven Plus™ usage combined with insulin pump) therapy was retrospectively evaluated in 28 children (15 boys) younger than 7 years (mean age, 5.8 ± 1.2 years; range, 3-7 years), with T1D. Glycosylated hemoglobin (HbA1c) was evaluated at baseline and at the end of the study, as were efficacy and feasibility of the system, using a rating scale (with 3 being the most positive). SAP has been used for at least 6 months by 85% of patients, with an overall good satisfaction (92%). The greatest perceived benefit was the reduced fear of hypoglycemia (score of 3, 81%). HbA1c significantly improved only in patients with baseline HbA1c >7.5% (P = 0.026). SAP therapy is effective and feasible in preschool children with T1D. In patients with high HbA1c at baseline it provide a 0.9% decrease, sustained for at least 6 months.

Development and Adaptation of Iranian Youth Reproductive Health Questionnaire

PubMed Central

Mousavi, Abbas; Keramat, Afsaneh; Vakilian, Katayon; Esmaeili Vardanjani, Safar Ali

2013-01-01

Iran is a young country, and sexual behavior is shaped in this period. This research aimed to provide an assessment tool to evaluate Iranian youth reproductive health. This multistage research was conducted to design a valid questionnaire in the domains of knowledge, attitude, and behavior of the youth in order to evaluate behavior change programs. For this reason, after conducting a careful literature review and a qualitative research, the questionnaire was prepared. Forward and backward translations were performed. Professionals and students were used to make sure of qualitative and quantitative content and face validity. After conducting the pilot study on 100 students and eliminating defects in performance, reliability was evaluated by test-retest and Cronbach's alpha was calculated. In this study, out of 268 questions, 198 were retained after face and content validity. Self-efficacy of communication with father and mother, self-efficacy of condom use, and self-efficacy of abstinence had the highest Cronbach's alpha. Moreover, communication with parents regarding reproductive health issues and attitude to abstinence had a high Cronbach's alpha, as well. It seems to be a good instrument for assessment of Iranian reproductive health, and we are going to assess youth reproductive health in the future. PMID:23984084

Design and evaluation of a computer game to promote a healthy diet for young adults.

PubMed

Peng, Wei

2009-03-01

This article reports the development and evaluation of a computer game (RightWay Café) as a special medium to promote a healthy diet for young adults. Structural features of computer games, such as interactive tailoring, role playing, the element of fun, and narrative, were operationalized in the RightWay Café game to afford behavior rehearsal in a safe and entertaining way. Theories such as the health belief model, social cognitive theory, and theory of reasoned action guided the content design of the game to influence mediators of behavior change, including self-efficacy, perceived benefits, perceived barriers, and behavior change intention. A randomized controlled evaluation study with pretest, posttest, and follow-up design demonstrated that this game was effective in teaching nutrition and weight management knowledge and increasing people's self-efficacy and perceived benefits of healthy eating, as well as their intention to be on a healthy diet. Limited long-term effects were also found: participants in the game-playing group had greater self-efficacy than participants in the control group after 1 month. This study validates the computer game-based approach to health promotion for young adults. Limitations and implications are also discussed.

The Relationship Between Emotional Support and Health-Related Self-Efficacy in Older Prisoners.

PubMed

Noujaim, Deborah; Fortinsky, Richard H; Barry, Lisa C

2017-09-01

To determine whether emotional support, and proportion of emotional support provided by specific sources (e.g., family, other prisoners, clinicians), is associated with health-related self-efficacy among older prisoners. Cross-sectional study of 140 older prisoners age ≥50 with chronic medical illness who completed face-to-face interviews. Logistic regression, controlling for demographic, incarceration, and clinical/behavioral factors evaluated the association between emotional support, operationalized as a score and as a proportion of total emotional support from specific sources, and health-related self-efficacy. Higher emotional support scores, and greater proportion of support from clinicians, were associated with lower likelihood of poor health-related self-efficacy. Those with >50% of their emotional support coming from other prisoners had higher likelihood of poor self-efficacy. Among older prisoners with chronic illness, higher emotional support, particularly from clinicians, is associated with lower likelihood of poor self-efficacy; relying on other prisoners for emotional support is associated with poor health-related self-efficacy.

Commercialism, choice and consumer protection: regulation of complementary medicines in Australia.

PubMed

Harvey, Ken J; Korczak, Viola S; Marron, Loretta J; Newgreen, David B

2008-01-07

Controls on the supply and promotion of complementary medicines in Australia are weak. We used weight-loss products as an example to compare the regulation in Australia of listed complementary medicines and registered pharmaceutical products. Complementary medicines are listed without evaluation for efficacy, while conventional pharmaceutical products are registered after evaluation for quality, safety and efficacy. From 1996 to 2006, over 1000 "weight-loss" products were listed on the Australian Register of Therapeutic Goods; most contained multiple unevaluated ingredients (herbs, vitamins, minerals) of dubious efficacy. Over the same period, 10 conventional medicines were registered; each contained one evaluated ingredient of proven efficacy. The number of listed weight-loss products (and complaints about their promotion) is increasing. These appear to be a direct consequence of the decision not to evaluate listed products for efficacy and the lower fees for listing a product, compared with registration. Complaint procedures (now overloaded) are no substitute for adequate regulation at the time of market entry. Regulatory reform of listed and homoeopathic products is required.

Evaluating a Culturally Tailored HIV Risk Reduction Intervention Among Latina Immigrants in the Farmworker Community.

PubMed

Sanchez, Mariana; Rojas, Patria; Li, Tan; Ravelo, Gira; Cyrus, Elena; Wang, Weize; Kanamori, Mariano; Peragallo, Nilda P; De La Rosa, Mario R

2016-09-01

Latina immigrants in the farmworker community are a vulnerable and understudied population at risk of acquiring HIV. Employing a CBPR framework, this pilot study was the first to evaluate the efficacy of SEPA, a CDC evidenced-based and culturally tailored HIV risk reduction intervention on a cohort of N = 110 predominantly undocumented Latina immigrants in a farmworker community. Findings revealed SEPA was effective in increasing HIV knowledge and decreasing HIV risk behaviors. However, no changes in self-efficacy were found in the present sample. We posit specific socio-cultural and structural barriers specific to the farmworker community not targeted in the original intervention may have hindered the program's capacity to influence changes in self-efficacy among this less acculturated population. Possible socio-cultural adaptations of the intervention to the target population and policy implications are discussed.

In vivo evaluation method of the effect of nattokinase on carrageenan-induced tail thrombosis in a rat model.

PubMed

Kamiya, Seitaro; Hagimori, Masayori; Ogasawara, Masayoshi; Arakawa, Masayuki

2010-01-01

Thrombosis is characterized by congenital and acquired procatarxis. Nattokinase inhibits thrombus formation in vitro. However, in vivo evaluation of the therapeutic efficacy of nattokinase against thrombosis remains to be conducted. Subcutaneous nattokinase injections of 1 or 2 mg/ml were administered to the tails of rats. Subsequently, κ-carrageenan was intravenously administered to the tails at 12 h after nattokinase injections. The mean length of the infarcted regions in the tails of rats was significantly shorter in rats administered 2 mg/ml of nattokinase than those in control rats. Nattokinase exhibited significant prophylactic antithrombotic effects. Previously, the in vitro efficacy of nattokinase against thrombosis had been reported; now our study has revealed the in vivo efficacy of nattokinase against thrombosis. Copyright © 2010 S. Karger AG, Basel.

A behavioral medicine intervention for older women living alone with chronic pain – a feasibility study

PubMed Central

Cederbom, Sara; Rydwik, Elisabeth; Söderlund, Anne; Denison, Eva; Frändin, Kerstin; von Heideken Wågert, Petra

2014-01-01

Background To be an older woman, live alone, have chronic pain, and be dependent on support are all factors that may have an impact on daily life. One way to promote ability in everyday activities in people with pain-related conditions is to use individualized, integrated behavioral medicine in physical therapy interventions. How this kind of intervention works for older women living alone at home, with chronic pain, and dependent on formal care to manage their everyday lives has not been studied. The aim was to explore the feasibility of a study and to evaluate an individually tailored integrated behavioral medicine in physical therapy intervention for the target group of women. Materials and methods The study was a 12-week randomized trial with two-group design. Primary effect outcomes were pain-related disability and morale. Secondary effect outcomes focused on pain-related beliefs, self-efficacy for exercise, concerns of falling, physical activity, and physical performance. Results In total, 23 women agreed to participate in the study and 16 women completed the intervention. The results showed that the behavioral medicine in physical therapy intervention was feasible. No effects were seen on the primary effect outcomes. The experimental intervention seemed to improve the level of physical activity and self-efficacy for exercise. Some of the participants in both groups perceived that they could manage their everyday life in a better way after participation in the study. Conclusion Results from this study are encouraging, but the study procedure and interventions have to be refined and tested in a larger feasibility study to be able to evaluate the effects of these kinds of interventions on pain-related disability, pain-related beliefs, self-efficacy in everyday activities, and morale in the target group. Further research is also needed to refine and evaluate effects from individualized reminder routines, support to collect self-report data, safety procedures for balance training, and training of personnel to enhance self-efficacy. PMID:25170262

A behavioral medicine intervention for older women living alone with chronic pain - a feasibility study.

PubMed

Cederbom, Sara; Rydwik, Elisabeth; Söderlund, Anne; Denison, Eva; Frändin, Kerstin; von Heideken Wågert, Petra

2014-01-01

To be an older woman, live alone, have chronic pain, and be dependent on support are all factors that may have an impact on daily life. One way to promote ability in everyday activities in people with pain-related conditions is to use individualized, integrated behavioral medicine in physical therapy interventions. How this kind of intervention works for older women living alone at home, with chronic pain, and dependent on formal care to manage their everyday lives has not been studied. The aim was to explore the feasibility of a study and to evaluate an individually tailored integrated behavioral medicine in physical therapy intervention for the target group of women. The study was a 12-week randomized trial with two-group design. Primary effect outcomes were pain-related disability and morale. Secondary effect outcomes focused on pain-related beliefs, self-efficacy for exercise, concerns of falling, physical activity, and physical performance. In total, 23 women agreed to participate in the study and 16 women completed the intervention. The results showed that the behavioral medicine in physical therapy intervention was feasible. No effects were seen on the primary effect outcomes. The experimental intervention seemed to improve the level of physical activity and self-efficacy for exercise. Some of the participants in both groups perceived that they could manage their everyday life in a better way after participation in the study. Results from this study are encouraging, but the study procedure and interventions have to be refined and tested in a larger feasibility study to be able to evaluate the effects of these kinds of interventions on pain-related disability, pain-related beliefs, self-efficacy in everyday activities, and morale in the target group. Further research is also needed to refine and evaluate effects from individualized reminder routines, support to collect self-report data, safety procedures for balance training, and training of personnel to enhance self-efficacy.

Extended Safety, Immunogenicity and Efficacy of a Blood-Stage Malaria Vaccine in Malian Children: 24-Month Follow-Up of a Randomized, Double-Blinded Phase 2 Trial

PubMed Central

Laurens, Matthew B.; Thera, Mahamadou A.; Coulibaly, Drissa; Ouattara, Amed; Kone, Abdoulaye K.; Guindo, Ando B.; Traore, Karim; Traore, Idrissa; Kouriba, Bourema; Diallo, Dapa A.; Diarra, Issa; Daou, Modibo; Dolo, Amagana; Tolo, Youssouf; Sissoko, Mahamadou S.; Niangaly, Amadou; Sissoko, Mady; Takala-Harrison, Shannon; Lyke, Kirsten E.; Wu, Yukun; Blackwelder, William C.; Godeaux, Olivier; Vekemans, Johan; Dubois, Marie-Claude; Ballou, W. Ripley; Cohen, Joe; Dube, Tina; Soisson, Lorraine; Diggs, Carter L.; House, Brent; Bennett, Jason W.; Lanar, David E.; Dutta, Sheetij; Heppner, D. Gray; Plowe, Christopher V.; Doumbo, Ogobara K.

2013-01-01

Background The FMP2.1/AS02A candidate malaria vaccine was tested in a Phase 2 study in Mali. Based on results from the first eight months of follow-up, the vaccine appeared well-tolerated and immunogenic. It had no significant efficacy based on the primary endpoint, clinical malaria, but marginal efficacy against clinical malaria in secondary analyses, and high allele-specific efficacy. Extended follow-up was conducted to evaluate extended safety, immunogenicity and efficacy. Methods A randomized, double-blinded trial of safety, immunogenicity and efficacy of the candidate Plasmodium falciparum apical membrane antigen 1 (AMA1) vaccine FMP2.1/AS02A was conducted in Bandiagara, Mali. Children aged 1–6 years were randomized in a 1∶1 ratio to receive FMP2.1/AS02A or control rabies vaccine on days 0, 30 and 60. Using active and passive surveillance, clinical malaria and adverse events as well as antibodies against P. falciparum AMA1 were monitored for 24 months after the first vaccination, spanning two malaria seasons. Findings 400 children were enrolled. Serious adverse events occurred in nine participants in the FMP2.1/AS02A group and three in the control group; none was considered related to study vaccination. After two years, anti-AMA1 immune responses remained significantly higher in the FMP2.1/AS02A group than in the control group. For the entire 24-month follow-up period, vaccine efficacy was 7.6% (p = 0.51) against first clinical malaria episodes and 9.9% (p = 0.19) against all malaria episodes. For the final 16-month follow-up period, vaccine efficacy was 0.9% (p = 0.98) against all malaria episodes. Allele-specific efficacy seen in the first malaria season did not extend into the second season of follow-up. Interpretation Allele-specific vaccine efficacy was not sustained in the second malaria season, despite continued high levels of anti-AMA1 antibodies. This study presents an opportunity to evaluate correlates of partial protection against clinical malaria that waned during the second malaria season. Trial Registration Clinicaltrials.gov NCT00460525 NCT00460525 PMID:24260195

Self-efficacy beliefs of medical students: a critical review.

PubMed

Klassen, Robert M; Klassen, Joel R L

2018-04-01

Self-efficacy is a theoretically and empirically robust motivation belief that has been shown to play an important role in the learning and development of new skills and knowledge. In this article, we critically review research on the self-efficacy beliefs of medical students, with a goal to evaluate the existing research and to strengthen future work. In particular, we sought to describe the state of research on medical student self-efficacy and to critically examine the conceptualization and measurement of the construct. Finally, we aimed to provide directions for future self-efficacy research. We critically reviewed 74 published articles that included measures of self-efficacy beliefs of medical students. Our review showed that (a) research on the self-efficacy beliefs of medical students is growing and is becoming increasingly international, and (b) that nearly half (46%) of self-efficacy measures showed conceptual and operational flaws. Our critical review of 74 research studies on self-efficacy of medical students found that although research in the field is increasing, nearly half of measures labelled as self-efficacy were incongruent with the conceptual guidelines set by self-efficacy experts. We provide five suggestions for future research on the self-efficacy of medical students.

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.

Impact of critical thinking disposition, general self-efficacy, and leadership on clinical competence in nursing students.

PubMed

Park, Jee Won; Kim, Chun Ja; Kim, Yong Soon; Yoo, Moon Sook; Yoo, Hyera; Chae, Sun Mi; Ahn, Jeong Ah

2012-09-01

The purpose of this study was to evaluate the relationships among critical thinking disposition, general self-efficacy, leadership and clinical competence, and identify the factors influencing clinical competence in nursing students. In this descriptive study, 153 nursing students (from 2nd to 4th school year) of a university in South Korea were enrolled in December 2010. The instruments for this study were the Korean versions of the Critical Thinking Disposition Scale, General Self-Efficacy Scale, Leadership Inventory, and Clinical Competence Scale. Data were analyzed by descriptive statistics, t-test, MANOVA, Pearson correlation, and multiple linear regression with PASW 18.0 software. The mean scores (ranging from 1 to 5) in nursing students for critical thinking disposition, general self-efficacy, leadership, and clinical competence were 3.44, 3.51, 3.55, and 3.42, respectively. Positive correlations were found for clinical competence with critical thinking disposition, general self-efficacy, and leadership. The strongest predictor of clinical competence was leadership. In addition, leadership, nursing school year, and subjective academic achievement accounted for 34.5% of variance in clinical competence. This study revealed that developing leadership, critical thinking disposition, and self-efficacy in undergraduate nursing education is important to improve clinical competence of nursing students.

A multicenter randomized double-blind study on the efficacy and safety of nicergoline in patients with multi-infarct dementia.

PubMed

Herrmann, W M; Stephan, K; Gaede, K; Apeceche, M

1997-01-01

A 6-month double-blind, randomized, placebo-controlled clinical trial preceded by a 3-week single-blind, washout/run-in placebo phase was performed in male and female patients, 55-85 years of age with a clinical diagnosis of mild to moderate multi-infarct dementia according to DSM-III to evaluate the therapeutic efficacy and safety of nicergoline 30 mg b.i.d. Primary endpoints for efficacy were the changes in the Sandoz Clinical Assessment Geriatric Scale (SCAG) and Mini-Mental State Examination (MMSE) scores at the end of the treatment with respect to baseline. Secondary endpoints were Clinical Global Impression, 3 subtests of the Weschsler Adult Intelligence Scale and Blessed A scale for activities of daily living, and all endpoints in 2-month intervals. A total of 252 patients were screened, 136 patients entered the double-blind phase and were evaluated as intent-to-treat (ITT) patients. Fifteen patients were excluded from the efficacy analyses of valid cases (VC) due to protocol violations or because they dropped out of the study prematurely. Confirmatory efficacy analysis after 6 months of treatment revealed superiority of nicergoline treatment with p < 0.01 for both SCAG and MMSE scores (ITT and VC). Subsequent descriptive efficacy analysis resulted in significant differences in favor of nicergoline, in the majority of cases as early as 2 months after start of treatment. Nicergoline was well tolerated and a similar number of adverse events were observed in both the placebo and the nicergoline group.

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.

Educational-entertainment as an intervention with Black adolescents exposed to community violence.

PubMed

Allen, Valerie Dorsey; Solomon, Phyllis

2012-01-01

Witnessing violence is one adverse childhood experience (ACE) associated with living in impoverished Black urban communities. Youth with higher violence avoidance self-efficacy and positive coping are more likely to avoid violence. This study evaluates educational entertainment (edutainment) as an intervention with Black adolescents exposed to community violence. Edutainment has shown success in increasing self-efficacy and positive coping skills in other domains. Self-administered scales were used to measure stress, anxiety, violence avoidance self-efficacy, and coping strategies. Data were collected pre- and nine days post-interventions/no intervention from 20 subjects receiving the edutainment intervention, 19 subjects participating in a group discussion about violence, and 21 subjects receiving no intervention (N = 60). Edutainment and no intervention were more effective than group discussion alone in increasing violence avoidance self-efficacy. Violence avoidance self-efficacy was found to have an intervening relationship between edutainment and the outcome of stress. This study indicates limited but positive effects for edutainment.

The importance of exercise self-efficacy for clinical outcomes in pulmonary rehabilitation.

PubMed

Selzler, Anne-Marie; Rodgers, Wendy M; Berry, Tanya R; Stickland, Michael K

2016-11-01

Pulmonary rehabilitation (PR) improves functional exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD), although these outcomes are often not maintained following PR. Self-efficacy is a precursor to outcomes achievement, yet few studies have examined the importance of self-efficacy to outcome improvement during PR, or how it develops over time. Further, the contribution of exercise-specific self-efficacy to outcomes in PR is unknown. The aims of this study were to determine (a) whether baseline exercise self-efficacy predicts PR attendance and change in functional exercise capacity and health status over PR, and (b) if exercise self-efficacy changes with PR. Fifty-eight out of 64 patients with COPD completed PR and assessments of exercise self-efficacy (task, coping, scheduling), the 6-minute walk test (6MWT), and St. George's Respiratory Questionnaire (SGRQ) at the beginning and end of PR. Analyses were conducted to predict attendance, and change in 6MWT and SGRQ, while controlling for baseline demographic and clinical indicators. Change in 6MWT, SGRQ, and self-efficacy with PR was also examined. Clinically significant increases in the 6MWT and SGRQ were achieved with PR. Stronger task self-efficacy predicted better attendance, while stronger coping self-efficacy predicted greater 6MWT improvement. No variables predicted SGRQ change. Scheduling self-efficacy significantly improved with PR, whereas task and coping self-efficacy did not. Baseline exercise self-efficacy appears to be a determinant of rehabilitation attendance and functional exercise improvement with PR. Clinicians should evaluate and target exercise self-efficacy to maximize adherence and health outcome improvement with PR. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

An integrative review: application of self-efficacy instruments for walking in populations with peripheral arterial disease.

PubMed

Caldieraro-Bentley, Angela J; Andrews, Jeannette O

2013-09-01

The study objective was to identify which self-efficacy measurement instruments are being used for walking in patients with peripheral arterial disease (PAD), the psychometrics of these instruments, and recommendations for use in research on patients with PAD. PAD is a common problem for individuals with similar risk factors as cardiovascular disease (CVD). Experts recommend a supervised walking program with incremental increases in speed and distance as an initial treatment for patients with intermittent claudication. Because patients may experience pain while walking, there is a tendency to be nonadherent with exercise therapy, and many limit or avoid walking all together, resulting in a sedentary lifestyle. Self-efficacy plays a role in determining a person's confidence in his or her ability to participate in an exercise program. Data sources for this study were PubMed, Cumulative Index of Nursing and Allied Health Literature, PsycINFO, and the Cochrane database. The integrative review method described by Wittemore and Knafl was used for this review (Wittemore R, Knafl K. The integrative review: updated methodology. J Adv Nurs 2005;52:546-53.). Publications were retrieved electronically and reviewed for inclusion on the basis of studies that measured self-efficacy for walking in populations with PAD, peripheral vascular disease, and CVD. The analysis consisted of 9 publications. Only 2 studies were specific to the population with PAD. The remaining studies addressed self-efficacy issues in CVD or congestive heart failure. The analysis identified 4 instruments based on Bandura's Social Cognitive Theory that were used to assess self-efficacy: (1) the Self-Efficacy Expectation Scale, (2) the Self-Efficacy for Managing Chronic Disease Scale, (3) the Performance-Based Efficacy Scale, and (4) the Barriers Self-Efficacy Scale. The Self-Efficacy Expectation Scale was most frequently used in these studies. The use of the Self-Efficacy Expectation Scale instruments for walking in patients with PAD is limited because reliability and validity have been demonstrated in an older, mostly white population with CVD and congestive heart failure. Instruments that encompass the key constructs of self-efficacy, including physical, personal, and environmental aspects, would allow full evaluation with identification of potential explanations for success or failure for the chosen outcome. This should be taken into consideration in future studies when using instruments of self-efficacy. Copyright © 2013 Society for Vascular Nursing, Inc. Published by Mosby, Inc. All rights reserved.

Adaptation and evaluation of the measurement properties of the Brazilian version of the Self-efficacy for Appropriate Medication Adherence Scale1

PubMed Central

Pedrosa, Rafaela Batista dos Santos; Rodrigues, Roberta Cunha Matheus

2016-01-01

Objectives: to undertake the cultural adaptation of, and to evaluate the measurement properties of, the Brazilian version of the Self-efficacy for Appropriate Medication Adherence Scale in coronary heart disease (CHD) patients, with outpatient monitoring at a teaching hospital. Method: the process of cultural adaptation was undertaken in accordance with the international literature. The data were obtained from 147 CHD patients, through the application of the sociodemographic/clinical characterization instrument, and of the Brazilian versions of the Morisky Self-Reported Measure of Medication Adherence Scale, the General Perceived Self-Efficacy Scale, and the Self-efficacy for Appropriate Medication Adherence Scale. Results: the Brazilian version of the Self-efficacy for Appropriate Medication Adherence Scale presented evidence of semantic-idiomatic, conceptual and cultural equivalencies, with high acceptability and practicality. The floor effect was evidenced for the total score and for the domains of the scale studied. The findings evidenced the measure's reliability. The domains of the Brazilian version of the Self-efficacy for Appropriate Medication Adherence Scale presented significant inverse correlations of moderate to strong magnitude between the scores of the Morisky scale, indicating convergent validity, although correlations with the measure of general self-efficacy were not evidenced. The validity of known groups was supported, as the scale discriminated between "adherents" and "non-adherents" to the medications, as well as to "sufficient dose" and "insufficient dose". Conclusion: the Brazilian version of the Self-efficacy for Appropriate Medication Adherence Scale presented evidence of reliability and validity in coronary heart disease outpatients. PMID:27192417

Return to running following knee osteochondral repair using an anti-gravity treadmill: A case report.

PubMed

Hambly, Karen; Poomsalood, Somruthai; Mundy, Emma

2017-07-01

The purpose of this study was to assess the impact of an anti-gravity treadmill return to running programme on self-efficacy and subjective knee function following knee osteochondral surgery. A 39-year-old otherwise healthy female endurance runner with a left knee femoral cartilage grade 3-4 defect 3 cm 2 . The patient underwent single step arthroscopic microfracture with Bone Marrow Aspirate Concentrate. An AlterG ® anti-gravity treadmill was used to manipulate loading during a graduated phased return to running over 8 weeks. Self-efficacy was evaluated using the Self-Efficacy for Rehabilitation outcomes scale (SER) and the Knee Self-Efficacy Scale (K-SES). Subjective knee function was evaluated using the Knee injury and Osteoarthritis Outcome Score (KOOS) and International Knee Documentation Committee Subjective Knee Form (IKDC). The programme resulted in improvements in SER (57%), K-SES present (89%) and K-SES future (65%) self-efficacy domains. The IKDC score demonstrated a clinically important improvement with an increase from 62.1 in week 1-86.2 in week 8 (39%). Only the KOOS Sport/Rec subscale showed a clinically important improvement from week 1 to week 8. The programme resulted in improved knee and rehabilitation self-efficacy and subjective knee function following osteochondral repair of the knee. This case report illustrates the importance of considering self-efficacy in rehabilitation after knee osteochondral surgery and highlights the potential role for anti-gravity treadmills in enhancing self-efficacy and subjective knee function in preparation for a return to sport. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Efficacy and tolerability of treatment with single doses of diethylcarbamazine (DEC) and DEC plus albendazole (ABZ) for three consecutive years in lymphatic filariasis: a field study in India.

PubMed

Kshirsagar, Nilima A; Gogtay, N J; Garg, B S; Deshmukh, P R; Rajgor, D D; Kadam, V S; Thakur, P A; Gupta, A; Ingole, N S; Lazdins-Helds, J K

2017-10-01

Lymphatic filariasis (LF) affects 73 countries, causes morbidity and impedes socioeconomic development. We had found no difference in safety and micro (Mf) and macro filarial action of single-dose diethylcarbamazine (DEC) and DEC + albendazole (ABZ) in an F01 study done in India (year 2000). There was a programmatic need to evaluate safety and efficacy of multiple annual treatments (F02). Subjects (155) from the F01 study, meeting inclusion-exclusion criteria, were enrolled in F02 and treated with further two annual doses of DEC or DEC + ABZ. Efficacy was evaluated for Mf positivity by peripheral smear (PS) and nucleopore (NP) filter, circulating filarial antigen (CFA) and filarial dance sign (FDS) positivity and Mf count at yearly follow-up. Safety was assessed for 5 days after drug administration. Total of 139 subjects evaluated for efficacy (69 DEC and 70 DEC + ABZ group). Mf positivity prevalence declined progressively by 95% (PS), 66% (NP), and 95% (PS) and 86% (NP); CFA positivity prevalence declined by 15% and 9%; FDS by 100% each; Mf count declined by 75.5 and 76.9% with three annual treatment of DEC and DEC + ABZ, respectively. Addition of ABZ did not show any advantage over DEC given as three annual rounds for LF. DEC and DEC + ABZ were well tolerated. There was no correlation between result of CFA and FDS, (both claimed to be indicative of adult worm). Analysis of published studies and our data indicate that macrofilaricidal effect of DEC/DEC + ABZ may be seen in children and not adults, with three or more annual dosing.

Efficacy and safety of icotinib in treating non-small cell lung cancer: a systematic evaluation and meta-analysis based on 15 studies.

PubMed

Biaoxue, Rong; Hua, Liu; Wenlong, Gao; Shuanying, Yang

2016-12-27

Icotinib is a new epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that developed and used in China; this work was to evaluate its efficacy and safety in treating non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib in treating NSCLC were identified from the databases of Medline, Web of Science, Embase and Cochrance Library. Pooled efficacy and safety of icotinib were calculated through a series of predefined search strategies. A total of 15 studies with 2,304 patients were involved in this study. The overall response rate (ORR) and disease control rate (DCR) of icotinib were 40.99% (95% CI: 33.77% to 48.22%) and 77.16% (95% CI: 51.43% to 82.31%). The pooled progression-free survival (PFS) and overall survival (OS) were 7.34 months (95% CI: 5.60 to 9.07) and 14.98 months (95% CI: 9.78 to 20.18). Patients with EGFR mutations exhibited better ORR (OR = 3.67, p < 0.001), DCR (OR = 1.39, p = 0.001) and PFS (11.0 ± 0.76 vs. 1.97 ± 0.82 months). Moreover, patients with rash had a higher ORR (OR = 2.14, p = 0.001) than those without rash. The common adverse effects (AEs) included skin rash (31.4%), diarrhea (14.2%), pruritus (6.7%) and hepatic toxicity (3.8%) and most of them were well tolerated. In conclusion, Icotinib is an effective and well tolerated regimen for Chinese patients with advanced NSCLC. Further randomized trials with large population are required to provide stronger evidence for icotinib in treating NSCLC.

Efficacy and safety of icotinib in treating non-small cell lung cancer: a systematic evaluation and meta-analysis based on 15 studies

PubMed Central

Biaoxue, Rong; Hua, Liu; Wenlong, Gao; Shuanying, Yang

2016-01-01

Icotinib is a new epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that developed and used in China; this work was to evaluate its efficacy and safety in treating non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib in treating NSCLC were identified from the databases of Medline, Web of Science, Embase and Cochrance Library. Pooled efficacy and safety of icotinib were calculated through a series of predefined search strategies. A total of 15 studies with 2,304 patients were involved in this study. The overall response rate (ORR) and disease control rate (DCR) of icotinib were 40.99% (95% CI: 33.77% to 48.22%) and 77.16% (95% CI: 51.43% to 82.31%). The pooled progression-free survival (PFS) and overall survival (OS) were 7.34 months (95% CI: 5.60 to 9.07) and 14.98 months (95% CI: 9.78 to 20.18). Patients with EGFR mutations exhibited better ORR (OR = 3.67, p < 0.001), DCR (OR = 1.39, p = 0.001) and PFS (11.0 ± 0.76 vs. 1.97 ± 0.82 months). Moreover, patients with rash had a higher ORR (OR = 2.14, p = 0.001) than those without rash. The common adverse effects (AEs) included skin rash (31.4%), diarrhea (14.2%), pruritus (6.7%) and hepatic toxicity (3.8%) and most of them were well tolerated. In conclusion, Icotinib is an effective and well tolerated regimen for Chinese patients with advanced NSCLC. Further randomized trials with large population are required to provide stronger evidence for icotinib in treating NSCLC. PMID:27893423

Development and evaluation of a self care program on breastfeeding in Japan: A quasi-experimental study.

PubMed

Awano, Masayo; Shimada, Keiko

2010-08-23

Although the importance of breastfeeding is well known in Japan, in recent years less than 50% of mothers were fully breastfeeding at one month after birth. The purpose of this study was to develop a self-care program for breastfeeding aimed at increasing mothers' breastfeeding confidence and to evaluate its effectiveness. A quasi-experimental pretest-posttest design was conducted in Japan. The intervention, a breastfeeding self-care program, was created to improve mothers' self-efficacy for breastfeeding. This Breastfeeding Self-Care Program included: information on the advantages and basics of breastfeeding, a breastfeeding checklist to evaluate breastfeeding by mothers and midwives, and a pamphlet and audiovisual materials on breastfeeding. Mothers received this program during their postpartum hospital stay.A convenience sample of 117 primiparous women was recruited at two clinical sites from October 2007 to March 2008. The intervention group (n = 55), who gave birth in three odd-numbered months, received standard care and the Breastfeeding Self-Care Program while the control group (n = 62) gave birth in three even numbered months and received standard breastfeeding care.To evaluate the effectiveness of the Breastfeeding Self-Care Program, breastfeeding self-efficacy and breastfeeding rate were measured early postpartum, before the intervention, and after the intervention at one month postpartum. The study used the Japanese version of The Breastfeeding Self-Efficacy Scale Short Form (BSES-SF) to measure self-efficacy. The BSES-SF score of the intervention group rose significantly from 34.8 at early postpartum to 49.9 at one month after birth (p < 0.01). For the control group, the score rose from 39.5 at early postpartum to 46.5 at one month after birth (p = 0.03). The early postpartum fully breastfeeding rate was 90% for the intervention group and 89% for the control group. At one month postpartum, the fully breastfeeding rate declined significantly to 65% for the control group compared to 90% for the intervention group (p = 0.02). Results indicate that the Breastfeeding Self-Care Program increased mothers' self-efficacy for breastfeeding and had a positive effect on the continuation of breastfeeding. UMIN000003517.

A Multi-Dimensional Instrument for Evaluating Taiwanese High School Students' Science Learning Self-Efficacy in Relation to Their Approaches to Learning Science

ERIC Educational Resources Information Center

Lin, Tzung-Jin; Tsai, Chin-Chung

2013-01-01

In the past, students' science learning self-efficacy (SLSE) was usually measured by questionnaires that consisted of only a single scale, which might be insufficient to fully understand their SLSE. In this study, a multi-dimensional instrument, the SLSE instrument, was developed and validated to assess students' SLSE based on the previous…

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…

Effects of a School Guidance Curriculum on Postsecondary Education-Going Literacy, Postsecondary Education-Going Access Aspirations, and Career and College Readiness Self-Efficacy

ERIC Educational Resources Information Center

Martinez, Robert Richard, Jr.

2015-01-01

The primary purpose of this study was to evaluate the delivery and content of a set of classroom guidance lessons designed to enhance postsecondary education-going literacy, postsecondary education-going access aspirations, and career and college readiness self-efficacy of 9th grade students attending a high school in a southeastern rural…

The Efficacy of Simulation as a Pedagogy in Facilitating Pre-Service Teachers' Learning about Emotional Self-Regulation and Its Relevance to the Teaching Profession

ERIC Educational Resources Information Center

De Jong, Terry; Lane, Jeniffer; Sharp, Sue

2012-01-01

This study was undertaken in response to the imperative of teacher education courses incorporating National Professional Standards for Teachers, in particular Standard 7, which deals with the professional engagement of teachers (AITSL, 2011). It aimed to evaluate the efficacy of simulation and active recall as a learner-centred pedagogy in…

Optimization of medium composition and cultural conditions for production of antifungal substances by Streptomyces platensis 3-10 and evaluation of its efficacy in suppression of clubroot disease of oilseed rape

USDA-ARS?s Scientific Manuscript database

This study was conducted to optimize the medium composition and cultural conditions for improving production of antifungal substances (AFS) by Streptomyces 3-10 and for enhancing its efficacy in suppression of clubroot disease of oilseed rape caused by Plasmodiophora brassicae. Results showed that t...

Efficacy, Outcomes, and Empowerment Evaluation of a School District NET Project, Part II: School and Community Impact. Research Brief.

ERIC Educational Resources Information Center

Miller-Whitehead, Marie

This study addressed assessing the efficacy and outcomes of a U.S. Department of Agriculture Nutrition Education Training (NET) project designed to increase awareness of health risk and wellness factors for grade 9 students. Although this paper reprises results from a survey of 125 ninth graders about the NET curriculum, the focus of this part of…

The Efficacy of a Perceptive Rehabilitation on Postural Control in Patients with Chronic Nonspecific Low Back Pain

ERIC Educational Resources Information Center

Paolucci, Teresa; Fusco, Augusto; Iosa, Marco; Grasso, Maria R.; Spadini, Ennio; Paolucci, Stefano; Saraceni, Vincenzo M.; Morone, Giovanni

2012-01-01

Patients with chronic low back pain have a worse posture, probably related to poor control of the back muscles and altered perception of the trunk midline. The aim of this study was to evaluate the efficacy of a perceptive rehabilitation in terms of stability and pain relief in patients with chronic nonspecific low back pain. Thirty patients were…

"Using Data" to Inform Decisions: How Teachers Use Data to Inform Practice and Improve Student Performance in Mathematics. Results from a Randomized Experiment of Program Efficacy

ERIC Educational Resources Information Center

Cavalluzzo, Linda; Geraghty, Thomas M.; Steele, Jennifer L.; Holian, Laura; Jenkins, Frank; Alexander, Jane M.; Yamasaki, Kelsey Y.

2014-01-01

The purpose of this study is to evaluate, using a randomized experimental design, the efficacy of TERC's "Using Data" program to change teacher behavior and improve student learning outcomes. The "Using Data" intervention provides professional development and technical assistance to teachers to help them use data…

Type of tomatoes and water rinse affect efficacy of acid washes against salmonella enterica inoculated on stem scar areas of tomatoes and on product quality

USDA-ARS?s Scientific Manuscript database

The study was conducted to evaluate the effects of post-treatment rinsing with water on the inactivation efficacy of acid treatments against Salmonella inoculated onto stem scar areas of two types of tomatoes. In addition, impact on fruit quality was investigated during 21 days post-treatment storag...

STUDIES ON CONTAMINANT BIODEGRADATION IN SLURRY, WAFER, AND COMPACTED SOIL TUBE REACTORS

EPA Science Inventory

A systematic experimental approach is presented to quantitatively evaluate biodegradation rates in intact soil systems. Knowledge of bioremediation rates in intact soil systems is important for evaluating the efficacy of in-situ biodegradation and approaches for enhancing degrad...

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

Plaque removal efficacy of two children's toothbrushes: a one-month study.

PubMed

Benson, B J; Henyon, G; Grossman, E

1993-01-01

Reach Wonder Grip toothbrush for children was evaluated for plaque removal efficacy and compared to the Colgate Plus Junior (extra soft). The subjects appeared at the test site with overnight (14-18 hours) plaque accumulation. After qualifying for the study, sixty-eight (68) subjects were randomly assigned one of the test brushes. They then participated in the test evaluation at the clinical site wherein plaque levels were measured before and after a one minute brushing. Plaque removal efficacy was evaluated by the Global Plaque Index (percent of tooth surface covered by stained deposit). The subjects then used the assigned toothbrush at home for one month and returned to the test site to repeat the baseline evaluations. After their final plaque evaluations, the subjects were given a new toothbrush from each brand to use at home for one week and the subject and the parent were asked to complete a preference questionnaire. Sixty-seven (67) subjects completed the one month study. After one month's use of twice per day brushing, neither of the test toothbrushes demonstrated any evidence of oral irritation that could be related to toothbrushing. The results indicated that Reach Wonder Grip for Children was significantly more effective (p < 0.05) than Colgate Plus Junior in removing overall (Global) plaque at the initial exam period. The preference questionnaire indicated that the Reach Wonder Grip toothbrush was preferred by both the children and their parents. It is concluded that the new Reach Wonder Grip toothbrush for children is safe and effective for plaque removal.

Efficacy of 10% whole Azadirachta indica (neem) chip as an adjunct to scaling and root planning in chronic periodontitis: A clinical and microbiological study.

PubMed

Vennila, K; Elanchezhiyan, S; Ilavarasu, Sugumari

2016-01-01

Anti-microbial therapy is essential along with conventional therapy in the management of periodontal disease. Instead of systemic chemical agents, herbal products could be used as antimicrobial agents. Herbal local drug delivery systems are effective alternative for systemic therapy in managing the chronic periodontal disease. In this study, 10% neem oil chip was used as a local drug delivery system to evaluate the efficacy in the periodontal disease management. Twenty otherwise healthy patients with the bilateral periodontal probing depth of 5-6 mm were included in the study. After scaling and root planning (SRP), 10% nonabsorbable neem chip was placed in the pocket in one side of the arch. Other side was done with SRP only. Clinical parameters were recorded on the baseline, 7th day, and 21st day. Plaque samples were obtained for a microbiological study on the baseline and 21st day. Porphyromonas gingivalis strains were seen using quantitative and qualitative polymerase chain reaction assay. All results were statistically evaluated. Clinical parameters showed statistically improved on the neem chip sites and presence of P. gingivalis strains were significantly reduced on the neem chip sites. Hence, 10% neem oil local delivery system delivers desired effects on P. gingivalis. Further research is needed to evaluate the neem oil efficacy on other periodontal pathogens.

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

Ambroxol chaperone therapy for neuronopathic Gaucher disease: A pilot study.

PubMed

Narita, Aya; Shirai, Kentarou; Itamura, Shinji; Matsuda, Atsue; Ishihara, Akiko; Matsushita, Kumi; Fukuda, Chisako; Kubota, Norika; Takayama, Rumiko; Shigematsu, Hideo; Hayashi, Anri; Kumada, Tomohiro; Yuge, Kotaro; Watanabe, Yoriko; Kosugi, Saori; Nishida, Hiroshi; Kimura, Yukiko; Endo, Yusuke; Higaki, Katsumi; Nanba, Eiji; Nishimura, Yoko; Tamasaki, Akiko; Togawa, Masami; Saito, Yoshiaki; Maegaki, Yoshihiro; Ohno, Kousaku; Suzuki, Yoshiyuki

2016-03-01

Gaucher disease (GD) is a lysosomal storage disease characterized by a deficiency of glucocerebrosidase. Although enzyme-replacement and substrate-reduction therapies are available, their efficacies in treating the neurological manifestations of GD are negligible. Pharmacological chaperone therapy is hypothesized to offer a new strategy for treating the neurological manifestations of this disease. Specifically, ambroxol, a commonly used expectorant, has been proposed as a candidate pharmacological chaperone. The purpose of this study was to evaluate the safety, tolerability, and neurological efficacy of ambroxol in patients with neuronopathic GD. This open-label pilot study included five patients who received high-dose oral ambroxol in combination with enzyme replacement therapy. Safety was assessed by adverse event query, physical examination, electrocardiography, laboratory studies, and drug concentration. Biochemical efficacy was assessed through evidence of glucocerebrosidase activity in the lymphocytes and glucosylsphingosine levels in the cerebrospinal fluid. Neurological efficacy was evaluated using the Unified Myoclonus Rating Scale, Gross Motor Function Measure, Functional Independence Measure, seizure frequency, pupillary light reflex, horizontal saccadic latency, and electrophysiologic studies. High-dose oral ambroxol had good safety and tolerability, significantly increased lymphocyte glucocerebrosidase activity, permeated the blood-brain barrier, and decreased glucosylsphingosine levels in the cerebrospinal fluid. Myoclonus, seizures, and pupillary light reflex dysfunction markedly improved in all patients. Relief from myoclonus led to impressive recovery of gross motor function in two patients, allowing them to walk again. Pharmacological chaperone therapy with high-dose oral ambroxol shows promise in treating neuronopathic GD, necessitating further clinical trials.

Interventions for post-infectious irritable bowel syndrome: a systematic review of treatment efficacy.

PubMed

Torbicki, Emma; Oh, Justin; Mishra, Sharmistha; Page, Andrea V; Boggild, Andrea K

2015-01-01

Post-infectious irritable bowel syndrome (PI-IBS) due to traveler's diarrhea is the second most common illness seen in post-travel clinics, yet its optimal management remains unknown. We performed a systematic review to evaluate treatment efficacy in PI-IBS. We searched Medline, EMBASE, LILACS, CINAHL, CAB abstracts, and the Cochrane Library to February 3, 2014 for intervention studies of the pharmacologic and non-pharmacologic management of PI-IBS and examined the evidence according to a modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) scale. Of 336 records, 9 studies were included. Eight studies of pharmacologic interventions examined 5 agents (mesalazine or mesalamine, ondansetron, prednisolone, cholestyramine, and metronidazole). One study examined the non-pharmacologic intervention of different infant nutritional formulas following acute gastroenteritis. The quality of the evidence to date was low, with small sample size (fewer than 50 participants) and short duration of follow-up. Overall, the efficacy of pharmacological treatment ranged from no benefit (ondansetron and prednisolone) to moderately beneficial (cholestyramine and metronidazole). The evidence for mesalazine was equivocal: one study showed benefit, two others showed none. Heterogeneity in outcome measures and low strength of evidence preclude recommendations on the optimal management of PI-IBS by a specific agent. More comparative intervention research into PI-IBS treatment is needed for consistent best practice in PI-IBS management. Clinicians may elect to pursue therapeutic trials of mesalazine, cholestyramine, or metronidazole in individual patients, but should be aware that data supporting the efficacy of these agents is limited.

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.

Efficacy and safety of CPAP in low- and middle-income countries

PubMed Central

Thukral, A; Sankar, M J; Chandrasekaran, A; Agarwal, R; Paul, V K

2016-01-01

We conducted a systematic review to evaluate the (1) feasibility and efficacy and (2) safety and cost effectiveness of continuous positive airway pressure (CPAP) therapy in low- and middle-income countries (LMIC). We searched the following electronic bibliographic databases—MEDLINE, Cochrane CENTRAL, CINAHL, EMBASE and WHOLIS—up to December 2014 and included all studies that enrolled neonates requiring CPAP therapy for any indication. We did not find any randomized trials from LMICs that have evaluated the efficacy of CPAP therapy. Pooled analysis of four observational studies showed 66% reduction in in-hospital mortality following CPAP in preterm neonates (odds ratio 0.34, 95% confidence interval (CI) 0.14 to 0.82). One study reported 50% reduction in the need for mechanical ventilation following the introduction of bubble CPAP (relative risk 0.5, 95% CI 0.37 to 0.66). The proportion of neonates who failed CPAP and required mechanical ventilation varied from 20 to 40% (eight studies). The incidence of air leaks varied from 0 to 7.2% (nine studies). One study reported a significant reduction in the cost of surfactant usage with the introduction of CPAP. Available evidence suggests that CPAP is a safe and effective mode of therapy in preterm neonates with respiratory distress in LMICs. It reduces the in-hospital mortality and the need for ventilation thereby minimizing the need for up-transfer to a referral hospital. But given the overall paucity of studies and the low quality evidence underscores the need for large high-quality studies on the safety, efficacy and cost effectiveness of CPAP therapy in these settings. PMID:27109089

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

Efficacy of curcumin for age-associated cognitive decline: a narrative review of preclinical and clinical studies.

PubMed

Sarker, Marjana Rahman; Franks, Susan F

2018-04-21

Processes such as aberrant redox signaling and chronic low-grade systemic inflammation have been reported to modulate age-associated pathologies such as cognitive impairment. Curcumin, the primary therapeutic component of the Indian spice, Turmeric (Curcuma longa), has long been known for its strong anti-inflammatory and antioxidant activity attributable to its unique molecular structure. Recently, an interest in this polyphenol as a cognitive therapeutic for the elderly has emerged. The purpose of this paper is to critically review preclinical and clinical studies that have evaluated the efficacy of curcumin in ameliorating and preventing age-associated cognitive decline and address the translational progress of preclinical to clinical efficacy. PubMed, semantic scholar, and Google scholar searches were used for preclinical studies; and clinicaltrials.gov , the Australian and New Zealand clinical trials registry, and PubMed search were used to select relevant completed clinical studies. Results from preclinical studies consistently demonstrate curcumin and its analogues to be efficacious for various aspects of cognitive impairment and processes that contribute to age-associated cognitive impairment. Results of published clinical studies, while mixed, continue to show promise for curcumin's use as a therapeutic for cognitive decline but overall remain inconclusive at this time. Both in vitro and in vivo studies have found that curcumin can significantly decrease oxidative stress, systemic inflammation, and obstruct pathways that activate transcription factors that augment these processes. Future clinical studies would benefit from including evaluation of peripheral and cerebrospinal fluid biomarkers of dementia and behavioral markers of cognitive decline, as well as targeting the appropriate population.

Efficacy and safety of CPAP in low- and middle-income countries.

PubMed

Thukral, A; Sankar, M J; Chandrasekaran, A; Agarwal, R; Paul, V K

2016-05-01

We conducted a systematic review to evaluate the (1) feasibility and efficacy and (2) safety and cost effectiveness of continuous positive airway pressure (CPAP) therapy in low- and middle-income countries (LMIC). We searched the following electronic bibliographic databases-MEDLINE, Cochrane CENTRAL, CINAHL, EMBASE and WHOLIS-up to December 2014 and included all studies that enrolled neonates requiring CPAP therapy for any indication. We did not find any randomized trials from LMICs that have evaluated the efficacy of CPAP therapy. Pooled analysis of four observational studies showed 66% reduction in in-hospital mortality following CPAP in preterm neonates (odds ratio 0.34, 95% confidence interval (CI) 0.14 to 0.82). One study reported 50% reduction in the need for mechanical ventilation following the introduction of bubble CPAP (relative risk 0.5, 95% CI 0.37 to 0.66). The proportion of neonates who failed CPAP and required mechanical ventilation varied from 20 to 40% (eight studies). The incidence of air leaks varied from 0 to 7.2% (nine studies). One study reported a significant reduction in the cost of surfactant usage with the introduction of CPAP. Available evidence suggests that CPAP is a safe and effective mode of therapy in preterm neonates with respiratory distress in LMICs. It reduces the in-hospital mortality and the need for ventilation thereby minimizing the need for up-transfer to a referral hospital. But given the overall paucity of studies and the low quality evidence underscores the need for large high-quality studies on the safety, efficacy and cost effectiveness of CPAP therapy in these settings.

Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial.

PubMed

Wheeler, Cosette M; Castellsagué, Xavier; Garland, Suzanne M; Szarewski, Anne; Paavonen, Jorma; Naud, Paulo; Salmerón, Jorge; Chow, Song-Nan; Apter, Dan; Kitchener, Henry; Teixeira, Júlio C; Skinner, S Rachel; Jaisamrarn, Unnop; Limson, Genara; Romanowski, Barbara; Aoki, Fred Y; Schwarz, Tino F; Poppe, Willy A J; Bosch, F Xavier; Harper, Diane M; Huh, Warner; Hardt, Karin; Zahaf, Toufik; Descamps, Dominique; Struyf, Frank; Dubin, Gary; Lehtinen, Matti

2012-01-01

We evaluated the efficacy of the human papillomavirus HPV-16/18 AS04-adjuvanted vaccine against non-vaccine oncogenic HPV types in the end-of-study analysis after 4 years of follow-up in PATRICIA (PApilloma TRIal against Cancer In young Adults). Healthy women aged 15-25 years with no more than six lifetime sexual partners were included in PATRICIA irrespective of their baseline HPV DNA status, HPV-16 or HPV-18 serostatus, or cytology. Women were randomly assigned (1:1) to HPV-16/18 vaccine or a control hepatitis A vaccine, via an internet-based central randomisation system using a minimisation algorithm to account for age ranges and study sites. The study was double-blind. The primary endpoint of PATRICIA has been reported previously; the present analysis evaluates cross-protective vaccine efficacy against non-vaccine oncogenic HPV types in the end-of-study analysis. Analyses were done for three cohorts: the according-to-protocol cohort for efficacy (ATP-E; vaccine n=8067, control n=8047), total vaccinated HPV-naive cohort (TVC-naive; no evidence of infection with 14 oncogenic HPV types at baseline, approximating young adolescents before sexual debut; vaccine n=5824, control n=5820), and the total vaccinated cohort (TVC; all women who received at least one vaccine dose, approximating catch-up populations that include sexually active women; vaccine n=9319, control=9325). Vaccine efficacy was evaluated against 6-month persistent infection, cervical intraepithelial neoplasia grade 2 or greater (CIN2+) associated with 12 non-vaccine HPV types (individually or as composite endpoints), and CIN3+ associated with the composite of 12 non-vaccine HPV types. This study is registered with ClinicalTrials.gov, number NCT00122681. Consistent vaccine efficacy against persistent infection and CIN2+ (with or without HPV-16/18 co-infection) was seen across cohorts for HPV-33, HPV-31, HPV-45, and HPV-51. In the most conservative analysis of vaccine efficacy against CIN2+, where all cases co-infected with HPV-16/18 were removed, vaccine efficacy was noted for HPV-33 in all cohorts, and for HPV-31 in the ATP-E and TVC-naive. Vaccine efficacy against CIN2+ associated with the composite of 12 non-vaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), with or without HPV-16/18 co-infection, was 46·8% (95% CI 30·7-59·4) in the ATP-E, 56·2% (37·2-69·9) in the TVC-naive, and 34·2% (20·4-45·8) in the TVC. Corresponding values for CIN3+ were 73·8% (48·3-87·9), 91·4% (65·0-99·0), and 47·5% (22·8-64·8). Data from the end-of-study analysis of PATRICIA show cross-protective efficacy of the HPV-16/18 vaccine against four oncogenic non-vaccine HPV types-HPV-33, HPV-31, HPV-45, and HPV-51-in different trial cohorts representing diverse groups of women. GlaxoSmithKline Biologicals. Copyright © 2012 Elsevier Ltd. All rights reserved.

78 FR 19649 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

...- year pilot study. This study, to be conducted in the exclusive economic zone (EEZ) of the Gulf of... effectiveness of a more timely electronic data reporting system; and evaluate the potential social and economic... conduct a pilot study to evaluate the efficacy of an allocation-based management strategy, which if proven...

A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy.

PubMed

Loo, Colleen K; Mitchell, Philip B

2005-11-01

There is a growing interest in extending the use of repetitive transcranial magnetic stimulation (rTMS) beyond research centres to the widespread clinical treatment of depression. Thus it is timely to critically review the evidence for the efficacy of rTMS as an antidepressant treatment. Factors relevant to the efficacy of rTMS are discussed along with the implications of these for the further optimization of rTMS. Clinical trials of the efficacy of rTMS in depressed subjects are summarized and reviewed, focusing mainly on sham-controlled studies and meta-analyses published to date. There is a fairly consistent statistical evidence for the superiority of rTMS over a sham control, though the degree of clinical improvement is not large. However, this data is derived mainly from two-week comparisons of rTMS versus sham, and evidence suggests greater efficacy with longer treatment courses. Studies so far have also varied greatly in approaches to rTMS stimulation (with respect to stimulation site, stimulus parameters etc) with little empirical evidence to inform on the relative merits of these approaches. Only studies published in English were reviewed. Many of the studies in the literature had small sample sizes and different methodologies, making comparisons between studies difficult. Current published studies and meta-analyses have evaluated the efficacy of rTMS as given in treatment paradigms that are almost certainly suboptimal (e.g of two weeks' duration). While the data nevertheless supports positive outcomes for rTMS, there is much scope for the further refinement and development of rTMS as an antidepressant treatment. Ongoing research is critical for optimizing the efficacy of rTMS.

Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan: one-year clinical outcomes (RECONFIRM-2)

PubMed Central

Takeuchi, Tsutomu; Inoue, Eisuke; Saito, Kazuyoshi; Sekiguchi, Naoya; Sato, Eri; Nawata, Masao; Kameda, Hideto; Iwata, Shigeru; Amano, Kouichi; Yamanaka, Hisashi

2008-01-01

Biologics targeting TNF have brought about a paradigm shift in the treatment of rheumatoid arthritis (RA) and infliximab, anti-TNF-α chimeric monoclonal antibody, was marketed in 2003 in Japan. We previously reported on the RECONFIRM study, a retrospective clinical study on the efficacy of infliximab therapy in a RA management group in Japan, where we evaluated the clinical response after 22 weeks of the therapy in 258 patients. The study reported here was aimed at reconfirming the clinical efficacy of the infliximab therapy and demographic factors related to the efficacy over a 54-week study period in 410 RA patients in the same study group. Infliximab was infused according to the domestically approved method, and the clinical response was evaluated following 54 weeks of infliximab therapy using the European League Against Rheumatism (EULAR) response criteria. Disease activity was assessed by DAS28-CRP (Disease Activity Score including a 28-joint count/C-reactive protein). Infliximab was discontinued in 24.4% of the 410 patients at 54 weeks and 9.3% and 8.1% discontinued the therapy due to adverse events and inefficiency, respectively. Average DAS28-CRP decreased from 5.5 at week 0 to 3.1 at week 54 after the therapy. Patients in remission and those showing low-, moderate-, and high-disease activity changed from 0.0, 1.0, 9.0 and 90.0%, respectively, at the start of the study to 27.6, 11.7, 34.4 and 26.3%, respectively, at week 54. Younger age, RF-negativity and low scores of DAS28-CRP showed significant correlations with remission at week 54. EULAR response criteria—good, moderate, and no response to infliximab—were 37.0, 41.7 and 21.2%, respectively. In conclusion, we reconfirmed the clinical efficacy of infliximab and demographic factors related to the efficacy over a 54-week study period in 410 Japanese patients with RA using DAS28-CRP and EULAR response criteria. PMID:18283523

Assessment of Self-Efficacy and its Relationship with Frailty in the Elderly

PubMed Central

Doba, Nobutaka; Tokuda, Yasuharu; Saiki, Keiichirou; Kushiro, Toshio; Hirano, Masumi; Matsubara, Yoshihiro; Hinohara, Shigeaki

2016-01-01

Objective It has been increasingly recognized in various clinical areas that self-efficacy promotes the level of competence in patients. The validity, applicability and potential usefulness of a new, simple model for assessing self-efficacy in the elderly with special reference to frailty were investigated for improving elderly patients' accomplishments. Methods The subjects of the present study comprised 257 elderly people who were members of the New Elder Citizen Movement in Japan and their mean age was 82.3±3.8 years. Interview materials including self-efficacy questionnaires were sent to all participants in advance and all other physical examinations were performed at the Life Planning Center Clinic. Results The internal consistency and close relation among a set of items used as a measure of self-efficacy were evaluated by Cronbach's alpha index, which was 0.79. Although no age-dependent difference was identified in either sex, gender-related differences in some factors were noted. Regarding several parametric parameters, Beck's inventory alone revealed a significant relationship to self-efficacy in both sexes. Additionally, non-parametric items such as stamina, power and memory were strongly correlated with self-efficacy in both sexes. Frailty showed a significant independent relationship with self-efficacy in a multiple linear regression model analysis and using Beck's inventory, stamina, power and memory were identified to be independent factors for self-efficacy. Conclusion The simple assessment of self-efficacy described in this study may be a useful tool for successful aging of elderly people. PMID:27725537

Assessment of Self-Efficacy and its Relationship with Frailty in the Elderly.

PubMed

Doba, Nobutaka; Tokuda, Yasuharu; Saiki, Keiichirou; Kushiro, Toshio; Hirano, Masumi; Matsubara, Yoshihiro; Hinohara, Shigeaki

Objective It has been increasingly recognized in various clinical areas that self-efficacy promotes the level of competence in patients. The validity, applicability and potential usefulness of a new, simple model for assessing self-efficacy in the elderly with special reference to frailty were investigated for improving elderly patients' accomplishments. Methods The subjects of the present study comprised 257 elderly people who were members of the New Elder Citizen Movement in Japan and their mean age was 82.3±3.8 years. Interview materials including self-efficacy questionnaires were sent to all participants in advance and all other physical examinations were performed at the Life Planning Center Clinic. Results The internal consistency and close relation among a set of items used as a measure of self-efficacy were evaluated by Cronbach's alpha index, which was 0.79. Although no age-dependent difference was identified in either sex, gender-related differences in some factors were noted. Regarding several parametric parameters, Beck's inventory alone revealed a significant relationship to self-efficacy in both sexes. Additionally, non-parametric items such as stamina, power and memory were strongly correlated with self-efficacy in both sexes. Frailty showed a significant independent relationship with self-efficacy in a multiple linear regression model analysis and using Beck's inventory, stamina, power and memory were identified to be independent factors for self-efficacy. Conclusion The simple assessment of self-efficacy described in this study may be a useful tool for successful aging of elderly people.

Group membership and social identity in addiction recovery.

PubMed

Buckingham, Sarah A; Frings, Daniel; Albery, Ian P

2013-12-01

Despite a growing interest in how group membership can positively impact health, little research has addressed directly the role social identity processes can have on recovery from addiction. Drawing on social identity theory and self-categorization theory, the present study investigated how recovery group membership can introduce a new social identity associated with recovery, compared to the social identity associated with addiction. We hypothesized that two processes--evaluative differentiation and identity preference--would be linked with higher self-efficacy and positive health outcomes (i.e., reduced relapse, lower levels of appetitive behavior, and elevated feelings of social connectedness [Study 2]). Study 1 recruited members (N = 61) from United Kingdom based mutual aid groups of Alcoholics Anonymous and Narcotics Anonymous. Study 2 recruited ex-smokers (N = 81) from online sources. In Study 1, evaluative differentiation was significantly related to lowered relapse and reduced appetitive behavior. Identity preference was related to higher levels of self-efficacy, which was related to months drug-free and reduced levels of appetitive behaviors. In Study 2, evaluative differentiation was related to identity preference. Identity preference was also related to higher self-efficacy, which in turn was related to lower relapse. Although exploratory, these results suggest that developing a social identity as a "recovering addict" or an "ex-smoker" and subsequently highlighting the difference between such identities may be a useful strategy for reducing relapse among people with problems associated with addictive behaviors. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Influence of Renal Function on the 52-Week Efficacy and Safety of the Sodium Glucose Cotransporter 2 Inhibitor Luseogliflozin in Japanese Patients with Type 2 Diabetes Mellitus.

PubMed

Haneda, Masakazu; Seino, Yutaka; Inagaki, Nobuya; Kaku, Kohei; Sasaki, Takashi; Fukatsu, Atsushi; Kakiuchi, Haruka; Sato, Yuri; Sakai, Soichi; Samukawa, Yoshishige

2016-01-01

To evaluate the influence of renal function on the efficacy and safety of the sodium glucose cotransporter 2 inhibitor luseogliflozin (TS-071) in Japanese patients with type 2 diabetes mellitus (T2DM). Study 1 was a 52-week, Phase III study to evaluate the efficacy and safety of 2.5 mg/d luseogliflozin (or increased to 5 mg/d) in patients with T2DM with moderate renal impairment. During the initial 24 weeks, efficacy and safety of luseogliflozin were compared with placebo. Study 2 was a pooled analysis of four 52-week, Phase III studies of luseogliflozin, including Study 1, to evaluate the efficacy and safety of luseogliflozin in patients with various degrees of renal function. Patients were stratified into 3 groups by baseline estimated glomerular filtration rate (eGFR): normal renal function (≥90 mL/min/1.73 m(2)), mild impairment (≥60 to <90 mL/min/1.73 m(2)), and moderate impairment (≥30 to <60 mL/min/1.73 m(2)). Patients with moderate impairment were further divided into those with mild-moderate (≥45 to <60 mL/min/1.73 m(2)) and moderate-severe (≥30 to <45 mL/min/1.73 m(2)). In both studies, efficacy end points included changes in glycated hemoglobin (HbA1c) level, fasting plasma glucose (FPG) level, and body weight. The safety end points included adverse events (AEs) and laboratory parameters. In Study 1, HbA1c, FPG, and body weight significantly decreased at Week 24 in patients treated with luseogliflozin compared with patients treated with placebo, with the decrease in these parameters also observed with luseogliflozin at Week 52. The incidence of AEs was similar between groups. In Study 2, 1030 patients were included (normal, 275; mildly impaired, 598; and moderately impaired, 157). At Week 52, HbA1c, FPG, and body weight were significantly decreased from baseline in all groups. In between-group comparisons, the decreases in HbA1c and body weight were significantly smaller in patients with moderate impairment than in those with normal function; however, the HbA1c-lowering efficacy was reduced by nearly half, whereas the efficacy of body weight lowering was not so much diminished in the moderate impairment group. Furthermore, a scatter plot showed that changes in HbA1c were more influenced by baseline HbA1c than by baseline eGFR. The incidence of AEs during 52 weeks was similar among all groups, with the majority being mild. Luseogliflozin improved glycemic control and reduced body weight in all eGFR groups, and its efficacy on HbA1c lowering was reduced in those with moderate renal impairment. Luseogliflozin was well tolerated and safe, with no significant safety issues identified, regardless of baseline eGFR. The study is registered with Clinical Trials Information/JapicCTI of the Japan Pharmaceutical Information Center, and the study registry identification numbers are JapicCTI-111507, JapicCTI-111508, JapicCTI-111509, and JapicCTI-111543. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Development and characterization of resveratrol nanoemulsions carrying dual-imaging agents

PubMed Central

Herneisey, Michele; Williams, Jonathan; Mirtic, Janja; Liu, Lu; Potdar, Sneha; Bagia, Christina; Cavanaugh, Jane E; Janjic, Jelena M

2016-01-01

Aim: Delivery of the natural anti-inflammatory compound resveratrol with nanoemulsions can dramatically improve its tissue targeting, bioavailability and efficacy. Current assessment of resveratrol delivery efficacy is limited to indirect pharmacological measures. Molecular imaging solves this problem. Results/methodology: Nanoemulsions containing two complementary imaging agents, near-infrared dye and perfluoropolyether (PFPE), were developed and evaluated. Nanoemulsion effects on macrophage uptake, toxicity and NO production were also evaluated. The presence of PFPE did not affect nanoemulsion size, zeta potential, colloidal stability, drug loading or drug release. Conclusion: PFPE nanoemulsions can be used in future studies to evaluate nanoemulsion biodistribution without interfering with resveratrol delivery and pharmacological outcomes. Developed nanoemulsions show promise as a versatile treatment strategy for cancer and other inflammatory diseases. Graphical abstract PMID:27834615

[Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].

PubMed

Kong, Wei-ping; Tao, Qing-wen; Zhang, Ying-ze; Yang, Shu; Xu, Yuan; Zhu, Xiao-xia; Jin, Yue; Yang, Wen-xue; Yan, Xiao-ping

2015-06-01

To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients. A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment. After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P < 0.05]. Scores for CM syndromes, BASDAI, night pain index, spinal pain index, PGA, CRP were improved in the BSG group (P < 0.05, P < 0.01). The incidence of adverse events in the BSG group was lower than that of the control group. BSG based on Shen supplementing, Du-channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

Efficacy and Safety of Oritavancin Relative to Vancomycin for Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in the Outpatient Setting: Results From the SOLO Clinical Trials.

PubMed

Lodise, Thomas P; Redell, Mark; Armstrong, Shannon O; Sulham, Katherine A; Corey, G Ralph

2017-01-01

The objective of this analysis was to evaluate the efficacy and safety of oritavancin compared with vancomycin for patients with acute bacterial skin and skin structure infections (ABSSSIs) who received treatment in the outpatient setting in the Phase 3 SOLO clinical trials. SOLO I and SOLO II were 2 identically designed comparative, multicenter, double-blind, randomized studies to evaluate the efficacy and safety of a single 1200-mg dose of intravenous (IV) oritavancin versus 7-10 days of twice-daily IV vancomycin for the treatment of ABSSSI. Protocols were amended to allow enrolled patients to complete their entire course of antimicrobial therapy in an outpatient setting. The primary efficacy outcome was a composite endpoint (cessation of spread or reduction in size of the baseline lesion, absence of fever, and no rescue antibiotic at early clinical evaluation [ECE]) (48 to 72 hours). Key secondary endpoints included investigator-assessed clinical cure 7 to 14 days after end of treatment (posttherapy evaluation [PTE]) and 20% or greater reduction in lesion area at ECE. Safety was assessed until day 60. Seven hundred ninety-two patients (oritavancin, 392; vancomycin, 400) received entire course of treatment in the outpatient setting. Efficacy response rates at ECE and PTE were similar (primary composite endpoint at ECE: 80.4% vs 77.5% for oritavancin and vancomycin, respectively) as was incidence of adverse events. Five patients (1.3%) who received oritavancin and 9 (2.3%) vancomycin patients were subsequently admitted to a hospital. Oritavancin provides a single-dose alternative to multidose vancomycin for treatment of ABSSSI in the outpatient setting. © The Author 2017. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

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

Safety self-efficacy and safety performance: potential antecedents and the moderation effect of standardization.

PubMed

Katz-Navon, Tal; Naveh, Eitan; Stern, Zvi

2007-01-01

The purpose of this paper is to suggest a new safety self-efficacy construct and to explore its antecedents and interaction with standardization to influence in-patient safety. The paper used a survey of 161 nurses using a self-administered questionnaire over a 14-day period in two large Israeli general hospitals. Nurses answered questions relating to four safety self-efficacy antecedents: enactive mastery experiences; managers as safety role models; verbal persuasion; and safety priority, that relate to the perceived level of standardization and safety self-efficacy. Confirmatory factor analysis was used to assess the scale's construct validity. Regression models were used to test hypotheses regarding the antecedents and influence of safety self-efficacy. Results indicate that: managers as safety role models; distributing safety information; and priority given to safety, contributed to safety self-efficacy. Additionally, standardization moderated the effects of safety self-efficacy and patient safety such that safety self-efficacy was positively associated with patient safety when standardization was low rather than high. Hospital managers should be aware of individual motivations as safety self-efficacy when evaluating the potential influence of standardization on patient safety. Theoretically, the study introduces a new safety self-efficacy concept, and captures its antecedents and influence on safety performance. Also, the study suggests safety self-efficacy as a boundary condition for the influence of standardization on safety performance. Implementing standardization in healthcare is problematic because not all processes can be standardized. In this case, self-efficacy plays an important role in securing patient safety. Hence, safety self-efficacy may serve as a "substitute-for-standardization," by promoting staff behaviors that affect patient safety.

Organs-on-a-chip: Current applications and consideration points for in vitro ADME-Tox studies.

PubMed

Ishida, Seiichi

2018-02-01

Assay systems using in vitro cultured cells are increasingly applied for evaluation of the efficacy, safety, and toxicity of drug candidates. In vitro cell-based assays have two main applications in the drug discovery process: searching for a compound that is effective against the target disease (seed investigation) and confirmation of safety during use of the identified compounds (safety assessment). Currently available in vitro cell-based assays have been designed to evaluate the efficacy and toxicity in single organs, but the in vivo pharmacokinetics and pharmacodynamics of the administered drug candidates have not been considered. Thus, an evaluation system that interconnects cell culture units, one of which has appropriate drug metabolism activities and the other assesses the efficacy and toxicity of compounds, is needed. Accordingly, the in vitro ADME-Tox culture system known as organs-on-a-chip has been proposed. In this review, after introducing the organs-on-a-chip system, the evaluation of enterohepatic circulation and the gut-liver axis relationship will be presented as an example of the application of the organs-on-a-chip system for ADME studies based on inter-organ network. Additionally, the functions required for the organs-on-a-chip system and the necessity of standardization of cells mounted on the chip system will be discussed. Copyright © 2018 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

Efficacy of Therapies for Postural Tachycardia Syndrome: A Systematic Review and Meta-analysis.

PubMed

Wells, Rachel; Elliott, Adrian D; Mahajan, Rajiv; Page, Amanda; Iodice, Valeria; Sanders, Prashanthan; Lau, Dennis H

2018-06-21

To identify the evidence base and evaluate the efficacy of each treatment for postural tachycardia syndrome (POTS) in light of a recent consensus statement highlighting the lack of treatment options with clear benefit to risk ratios for this debilitating condition. The CENTRAL (Cochrane Central Register of Controlled Trials), PubMed, and Embase databases from inception to May 2017 were searched using the terms postural AND tachycardia AND syndrome. A total of 135 full-text publications were screened after excluding duplicates (n=681), conference abstracts (n=467), and records that did not relate to POTS therapy (n=876). We included 28 studies with at least 4 patients with POTS in which symptomatic response was reported after more than 4 weeks of therapy. This review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Two investigators independently performed the data extraction and evaluated the quality of evidence. This study comprised 25 case series and 3 small randomized controlled trials that evaluated 755 and 103 patients with POTS, respectively. Interventions directed at increasing intravascular volume, increasing peripheral or splanchnic vascular tone, controlling heart rate, and increasing exercise tolerance demonstrate moderate efficacy (range, 51%-72%). Few data exist on their comparative effectiveness. Significant heterogeneities were seen in terms of patient age, symptom severity, and the measures used to evaluate treatment efficacy. The current evidence base to guide optimal management of patients with POTS is extremely limited. More high-quality collaborative research with standardized reporting of symptom response and treatment tolerability is urgently needed. Copyright © 2018 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

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.

A Mixed Method Exploration of the Efficacy of the Teacher Evaluation System in Southwestern Pennsylvania

ERIC Educational Resources Information Center

Johns, Caroline

2017-01-01

This mixed method study was a practitioner inquiry into the teacher evaluation system that was enacted as a result of Pennsylvania House Bill 1901 (Act 82 of 2012). The study was an effort to gain an in-depth understanding of (a) factors that led to the passage of the Act 82 teacher evaluation policy, (b) what the policy was intended to do, and…

Efficacy and safety of long-term losartan therapy demonstrated by a prospective observational study in Japanese patients with hypertension: The Japan Hypertension Evaluation with Angiotensin II Antagonist Losartan Therapy (J-HEALTH) study.

PubMed

Naritomi, Hiroaki; Fujita, Toshiro; Ito, Sadayoshi; Ogihara, Toshio; Shimada, Kazuyuki; Shimamoto, Kazuaki; Tanaka, Heizo; Yoshiike, Nobuo

2008-02-01

The Japan Hypertension Evaluation with Angiotensin II Antagonist Losartan Therapy (J-HEALTH) study is a nationwide, prospective, multicentered, observational study that was designed to enroll 30,000 hypertensive Japanese patients from more than 3,000 private practitioners. It is the first large-scale observational study to assess the efficacy and safety of losartan, an angiotensin II receptor antagonist, in Japan. Patients were enrolled between June 2000 and May 2002, and followed up to June 2005. The data from 29,850 patients were used for the analysis of safety and efficacy. These patients were treated with losartan mostly at a daily dose of 25-50 mg. The mean follow-up period was 2.9 years. The patients were aged 62.4+/-12.1 years (mean+/-SD) and their mean systolic/diastolic blood pressure was 165.3+/-17.2/94.3+/-11.7 mmHg (mean+/-SD). Mean blood pressure in patients who were evaluated for efficacy decreased from 165.8/94.8 mmHg (n=26,512) at baseline to 145.5/84.4 mmHg after 3 months (n=21,269) and 138.6/80.0 mmHg after 36 months of treatment (n=13,879). Blood pressure was well controlled during the study period by losartan alone or losartan-based combination therapy. In nearly half of the patients, blood pressure was reduced to less than 140/90 mmHg during the study period. In addition to its antihypertensive effect, losartan reduced the uric acid level in patients whose baseline uric acid level was > or =7 mg/dL. Losartan also prevented acceleration of proteinuria. Adverse drug reactions occurred in 1,081 of the 29,850 patients. Long-term losartan therapy was effective and well tolerated in Japanese clinical practice.

Assessing self-efficacy of frontline providers to perform newborn resuscitation in a low-resource setting.

PubMed

Olson, Kristian R; Caldwell, Aya; Sihombing, Melva; Guarino, A J; Nelson, Brett D; Petersen, Rebecca

2015-04-01

Newborn deaths comprise an alarming proportion of under-five mortality globally. In this retrospective cohort study, we investigated the effectiveness of focused newborn resuscitation training and delivery of a positive-pressure device in a rural midwife population in a low-resource setting. The present research attempts to better understand the extent to which knowledge and self-efficacy contribute to resuscitation attempts by birth attendants in practice. A one-year retrospective cohort analysis was undertaken in Aceh, Indonesia of two groups of community-based midwives, one having received formal training and a positive-pressure resuscitative device and the other receiving usual educational resources and management. A path analysis was undertaken to evaluate relative determinants of actual resuscitation attempts. 348 community-based midwives participated in the evaluation and had attended 3116 births during the preceding year. Path analysis indicated that formal training in resuscitation and delivery of a positive-pressure device were significantly related to both increased knowledge (β=0.55, p=0.001) and increased self-efficacy (β=0.52, p=0.001) in performing neonatal resuscitations with a positive-pressure device. However, training impacted actual resuscitation attempts only indirectly through a relationship with self-efficacy and with knowledge. Combined across groups, self-efficacy was significantly associated with positive pressure ventilation attempts (β=0.26, p<0.01) whereas knowledge was not (β=-0.05, p=0.39). Although, to date, evaluations of newborn resuscitation programs have primarily focused on training and has reported process indicators, these results indicate that in order to improve intrapartum-related hypoxic events ("birth asphyxia"), increased emphasis should be placed on participant self-efficacy and mastery of newborn resuscitation. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Evaluation of the efficacy of rotary vs. hand files in root canal preparation of primary teeth in vitro using CBCT.

PubMed

Musale, P K; Mujawar, S A V

2014-04-01

This in vitro study aimed to evaluate the efficacy of rotary ProFile, ProTaper, Hero Shaper and K-files in shaping ability, cleaning efficacy, preparation time and instrument distortion in primary molars. Sixty extracted primary mandibular second molars were divided into four equal groups: Group I K-file, Group II ProFile, Group III ProTaper file and Group IV Hero Shaper file. The shaping ability was determined by comparing pre- and post-instrumentation CBCT scans and data analysed with SPSS program using the Chi-square test. Cleaning efficacy was evaluated by the degree of India ink removal from the canal walls under stereomicroscopy. Instrumentation times were calculated for each tooth and instrument distortion was visually checked and duly noted. The cleaning efficacy and instrumentation time were determined using ANOVA with Tukey's correction. Instrument distortion was analysed using Chi-square test. The canal taper was significantly more conical for rotary files as compared to K-files with Chi-square test (p < 0.05). Cleaning efficacy of rotary files with average scores (Groups II- 0.68, III- 0.48 and IV- 0.58) was significantly better than K-files (Group I- 0.93) (p < 0.05). Mean instrumentation time with K-file (20.7 min) was significantly higher than rotary files (Groups II 8.9, III 5.6, and IV 8.1 min) (p < 0.05). Instrument distortion was observed in Group I (4.3%), while none of the rotary files were distorted. Rotary files prepared more conical canals in primary teeth than manual instruments. Reduced preparation time with rotary files enhances patient cooperation especially in young children.

Skin decontamination with mineral cationic carrier against sarin determined in vivo.

PubMed

Vucemilović, Ante; Hadzija, Mirko; Jukić, Ivan

2009-06-01

Our Institute's nuclear, biological, and chemical defense research team continuously investigates and develops preparations for skin decontamination against nerve agents. In this in vivo study, we evaluated skin decontamination efficacy against sarin by a synthetic preparation called Mineral Cationic Carrier (MCC) with known ion exchange, absorption efficacy and bioactive potential. Mice were treated with increasing doses of sarin applied on their skin, and MCC was administered immediately after contamination. The results showed that decontamination with MCC could achieve therapeutic efficacy corresponding to 3 x LD(50) of percutaneous sarin and call for further research.

Impact of ao-dake-humi, Japanese traditional bamboo foot stimulator, on lower urinary tract symptoms, constipation and hypersensitivity to cold: a single-arm prospective pilot study.

PubMed

Minagawa, Tomonori; Saitou, Tetsuichi; Suzuki, Toshiro; Domen, Takahisa; Yokoyama, Hitoshi; Ishikawa, Masakuni; Hirakata, Shiro; Nagai, Takashi; Nakazawa, Masaki; Ogawa, Teruyuki; Ishizuka, Osamu

2016-12-09

Ao-dake-humi is a traditional Japanese bamboo foot stimulator consisting of a half-pipe-shaped step made of bamboo used to stimulate the foot by stepping on it, and is commonly used to promote general health among the elderly in Japan. However, its efficacy has not been reported in the scientific literature. This study was performed to investigate the role of ao-dake-humi focusing on lower urinary tract symptoms (LUTS), constipation, and hypersensitivity to cold (HC). Participants with LUTS, constipation, or HC were enrolled in this study. Ao-dake-humi was used twice a day for 28 days. Before and 28 days after starting ao-dake-humi use, international prostate symptom score (IPSS), quality-of-life (QoL) score, and overactive bladder symptom score (OABSS) were measured to evaluate the efficacy of ao-dake-humi on LUTS. To evaluate the objective efficacy of ao-dake-humi on LUTS, a frequency-volume chart (FVC) was plotted in LUTS patients for 3 days. A visual analogue scale (VAS) was used to evaluate the efficacy of ao-dake-humi on constipation (VAS-constipation) and HC (VAS-HC) in the participants with constipation or HC. A total of 24 participants were enrolled in this study. Twenty-one participants had LUTS, 11 had constipation, and 17 participants had HC. IPSS, especially storage-subscore, QoL score and OABSS, decreased significantly after use of ao-dake-humi. The use of ao-dake-humi increased maximal bladder capacity, resulting in a significant decrease in urinary frequency as determined from the FVC. In accordance with the results of VAS-constipation and VAS-HC, both constipation and HC were significantly relieved after ao-dake-humi use. The results of this prospective pilot study indicated that ao-dake-humi is safe and has therapeutic efficacy in cases of LUTS, constipation and HC. The possibility of using ao-dake-humi as physical neuromodulation therapy was shown in the management of LUTS, constipation and HC. UMIN000019333 (UMIN-CTR, Registered October-15-2015) retrospectively registered.

Loss of Efficacy to Spinal Cord Stimulator Therapy: Clinical Evidence and Possible Causes.

PubMed

Aiudi, Christopher M; Dunn, Roger Y; Burns, Sara M; Roth, Sarah A; Opalacz, Arissa; Zhang, Yi; Chen, Lucy; Mao, Jianren; Ahmed, Shihab U

2017-11-01

Although spinal cord stimulation (SCS) therapy has been shown to be efficacious in various pain conditions, the ability for SCS therapy to maintain long-term efficacy has been questioned. The purpose of this study was to investigate whether a loss of efficacy (LOE) phenomenon exists with SCS therapy and to investigate if this phenomenon is more apparent in any specific patient population. A retrospective, observation chart review was conducted to evaluate the patient response to SCS therapy over time. Massachusetts General Hospital, Boston, Massachusetts. Patients who received a SCS at the Massachusetts General Hospital, between January 1, 2002 and December 31, 2012, were invited to participate. A total of 62 patients were included in this study. Various models were created to analyze pain score changes over time using 2-tailed statistical analysis. Additionally, one-way ANOVA and Pearson's chi-square tests were used to determine if certain patient characteristics were associated with LOE. Compared to the visual analog scale (VAS) score at one month after device implantation, pain scores increased 1.95 points after 2 years (95% CI: 1.06 to 2.84, P = < 0.001). There were no significant differences in baseline characteristics between the groups of patients who did and did not lose efficacy of their therapy. However, those who experienced LOE had a baseline SCS therapy VAS score 3.09 points lower than those who did not (95% CI: 1.69 to 4.48, P = < 0.001). This study had several limitations including the retrospective nature of its design, confounders to VAS scores, small sample size, missing data points, and the evaluation of only conventional, low-frequency SCS therapy. Patients who received a SCS had a significant increase in VAS scores over time. Our data did not show any baseline patient characteristic that helped predict LOE. However, patients who have significant baseline response to therapy may be more likely to experience LOE. Spinal cord stimulation, chronic pain, retrospective study, low frequency electrical stimulation, efficacy, chronic pain therapy.

A simple hemostasis model for the quantitative evaluation of hydrogel-based local hemostatic biomaterials on tissue surface.

PubMed

Murakami, Yoshihiko; Yokoyama, Masayuki; Nishida, Hiroshi; Tomizawa, Yasuko; Kurosawa, Hiromi

2008-09-01

Several hemostat hydrogels are clinically used, and some other agents are studied for safer, more facile, and more efficient hemostasis. In the present paper, we proposed a novel method to evaluate local hemostat hydrogel on tissue surface. The procedure consisted of the following steps: (step 1) a mouse was fixed on a cork board, and its abdomen was incised; (step 2) serous fluid was carefully removed because it affected the estimation of the weight gained by the filter paper, and parafilm and preweighted filter paper were placed beneath the liver (parafilm prevented the filter paper's absorption of gradually oozing serous fluid); (step 3) the cork board was tilted and maintained at an angle of about 45 degrees so that the bleeding would more easily flow from the liver toward the filter paper; and (step 4) the bleeding lasted for 3 min. In this step, a hemostat was applied to the liver wound immediately after the liver was pricked with a needle. We found that (1) a careful removal of serous fluid prior to a bleeding and (2) a quantitative determination of the amount of excess aqueous solution that oozed out from a hemostat were important to a rigorous evaluation of hemostat efficacy. We successfully evaluated the efficacy of a fibrin-based hemostat hydrogel by using our method. The method proposed in the present study enabled the quantitative, accurate, and easy evaluation of the efficacy of local hemostatic hydrogel which acts as tissue-adhesive agent on biointerfaces.

Combination Immunotherapy in Non-small Cell Lung Cancer.

PubMed

Marmarelis, Melina E; Aggarwal, Charu

2018-05-08

Checkpoint blockade has changed the treatment landscape in non-small cell lung cancer (NSCLC), but single-agent approaches are effective for only a select subset of patients. Here, we will review the evidence for combination immunotherapies in NSCLC and the clinical data evaluating the efficacy of this approach. Clinical trials evaluating combination PD-1 and CTLA-4 blockade as well as PD-1 in combination with agents targeting IDO1, B7-H3, VEGF, and EGFR show promising results. Additional studies targeting other immune pathways like TIGIT, LAG-3, and cellular therapies are ongoing. Combination immunotherapy has the potential to improve outcomes in NSCLC. Data from early clinical trials is promising and reveals that these agents can be administered together safely without a significant increase in toxicity. Further studies are needed to evaluate their long-term safety and efficacy and to determine appropriate patient selection.

Diagnostic role of magnetic resonance imaging in assessing orofacial pain and paresthesia.

PubMed

Ohba, Seigo; Yoshimura, Hitoshi; Matsuda, Shinpei; Kobayashi, Junichi; Kimura, Takashi; Aiki, Minako; Sano, Kazuo

2014-09-01

The aim of this study was to compare the efficacy of CT and MRI in evaluating orofacial pain and paresthesia. A total of 96 patients with orofacial pain and/or paresthesia were included in this study. The patients who underwent CT and/or MRI examinations were assessed, and the efficacy of CT and/or MRI examinations in detecting the causative disease of the orofacial pain and paresthesia was evaluated. Seventy (72.9%) of 96 patients underwent CT and/or MRI examinations. Whereas CT examinations detected 2 diseases (4.5%) in 44 tests, 13 diseases (37.1%) were detected in 35 MRI examinations. Seven (53.8%) of 13 diseases, which were detected by MRI, were found in elderly patients. A high percentage of patients, who claimed orofacial pain and paresthesia, have other diseases in their brain, especially in elderly patients, and MRI is more useful than CT for evaluating these patients.

Evaluating the Efficacy of Nocturnal Continuous Subcutaneous Apomorphine Infusion in Sleep Disorders in Advanced Parkinson's Disease: The APO-NIGHT Study.

PubMed

Fernández-Pajarín, Gustavo; Sesar, Ángel; Ares, Begoña; Castro, Alfonso

2016-10-19

There are not many data about the beneficial effect of nocturnal continuous subcutaneous apomorphine infusion (NCSAI) over sleep disturbances in advanced Parkinson's disease (PD). Evaluate the effect of the NCSAI in sleeping problems and insomnia due to nocturnal hypokinesia inadvanced PD. We assessed 17 advanced PD patients with several sleep disturbances measured by SCOPA-SLEEP and PDSS scales. All the patients were on apomorphine infusion during daytime. This therapy was extended to nighttime. We evaluated the patients before the onset and after six weeks with NCSAI. NCSAI allowed highly significant improvements in SCOPA-SLEEP and PDSS scales (p<0.0001), and daytime somnolence. NCSAI was well tolerated with no major adverse effects were noticed. This study shows and confirms the efficacy of NCSAI on the sleep disturbances related to advanced PD. We provide an easy protocol to start this therapy.

Coping self-efficacy of Chinese nursing undergraduates with their research projects.

PubMed

Zhang, Wei; Li, Kun; Zhang, XiuMin; Chen, Li

2016-10-01

Undergraduate nursing education includes both professional knowledge and research skills. With regard to training nursing professionals for future healthcare settings, the ability to conduct research is fundamental for nurses after they graduate from universities. However, how nursing students develop coping self-efficacy and scientific skills as a specific ability during their professional study has received little attention. We studied nursing undergraduates' scientific research ability and its associated factors in the Chinese context and evaluated their self-efficacy for coping with research tasks. A total of 134 nursing undergraduates participated in the study. A purposely designed 22-item questionnaire was used to quantify students' research ability in implementing their research projects and the associated factors. Coping self-efficacy was measured with a modified Chinese version. The mean total self-efficacy score was 50.78±6.604 (M±SD). The majority (63.4%) of the students' coping self-efficacy was at a moderate level. Having "the ability to write a manuscript before conducting research projects" (P=0.006) and "topics determined by instructors after discussion with group members" (P=0.005) were the two predictive factors of good coping self-efficacy in students. Nursing undergraduates' self-efficacy was high enough to cope with their scientific research projects, but the information on procedures needed for project application was not abundant, and new training programs might be needed to meet the needs of nursing undergraduates. We should make full use of the predictors of good coping self-efficacy and promote nursing undergraduates' research ability. Copyright © 2016 Elsevier Ltd. All rights reserved.

Field efficacy of acaricides against Varroa destructor

PubMed Central

Gracia, María Jesús; Moreno, Carlos; Ferrer, Montserrat; Sanz, Alfredo; Peribáñez, Miguel Ángel; Estrada, Rosa

2017-01-01

Field trials were conducted in Northeast Spain (Aragón) to evaluate the effectiveness of two acaricides against Varroa destructor. These experiments took into account the season of the year, apiary, colony, and developmental state and strength of the colony. The acaricides used were a synthetic (amitraz, Apivar®) and a natural (formulated from Api Life Var®, thymol oil and thymol alcohol) product. The treatments used in the present study reduce high infestations of V. destructor, although they do not eliminate the infestation. Similar efficacies between treatments were found. Nevertheless, the efficacy of a treatment depends on the apiary where applied. Moreover, the detected variability in the apiary and hive poses a challenge to the identification of the significant factors. Therefore, more field studies to assess efficacies in several apiaries are needed to obtain a better understanding of the effects of the applied treatments. PMID:28158303

Quantitative methods for evaluating the efficacy of thalamic deep brain stimulation in patients with essential tremor.

PubMed

Wastensson, Gunilla; Holmberg, Björn; Johnels, Bo; Barregard, Lars

2013-01-01

Deep brain stimulation (DBS) of the thalamus is a safe and efficient method for treatment of disabling tremor in patient with essential tremor (ET). However, successful tremor suppression after surgery requires careful selection of stimulus parameters. Our aim was to examine the possible use of certain quantitative methods for evaluating the efficacy of thalamic DBS in ET patients in clinical practice, and to compare these methods with traditional clinical tests. We examined 22 patients using the Essential Tremor Rating Scale (ETRS) and quantitative assessment of tremor with the stimulator both activated and deactivated. We used an accelerometer (CATSYS tremor Pen) for quantitative measurement of postural tremor, and a eurythmokinesimeter (EKM) to evaluate kinetic tremor in a rapid pointing task. The efficacy of DBS on tremor suppression was prominent irrespective of the method used. The agreement between clinical rating of postural tremor and tremor intensity as measured by the CATSYS tremor pen was relatively high (rs = 0.74). The agreement between kinetic tremor as assessed by the ETRS and the main outcome variable from the EKM test was low (rs = 0.34). The lack of agreement indicates that the EKM test is not comparable with the clinical test. Quantitative methods, such as the CATSYS tremor pen, could be a useful complement to clinical tremor assessment in evaluating the efficacy of DBS in clinical practice. Future studies should evaluate the precision of these methods and long-term impact on tremor suppression, activities of daily living (ADL) function and quality of life.

Istartsmart: An Evaluative Study on a College Success Course

ERIC Educational Resources Information Center

Kruse, Heather L.

2014-01-01

The researcher for this evaluative study investigated the efficacy and impact of the iStartSmart college success course by examining the first-term retention, fall-to-fall persistence, and three-year completion rates of community college students who enrolled in the one- or three-credit course at a community college in Arizona and the rates of…

An Evaluation of the Preschool PATHS Curriculum on the Development of Preschool Children

ERIC Educational Resources Information Center

Hughes, Cerian; Cline, Tony

2015-01-01

This study evaluated the efficacy of preschool Promoting Alternative Thinking Strategies (PATHS), an early years curriculum designed to improve children's social and emotional competence, and reduce problem behaviour. Fifty-seven children aged three to four years took part in the study over one academic year. The control group (Group 1) received…

Evaluation of Two Instruction Methods to Increase Employment Options for Young Adults with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Burke, Raymond V.; Andersen, Melissa N.; Bowen, Scott L.; Howard, Monica R.; Allen, Keith D.

2010-01-01

We evaluated the efficacy of a vocational training program including behavioral skills training, and a "performance cue system" (i.e., a proprietary iPhone application adapted for the study) to teach targeted social-vocational skills to six young adults with an Autism Spectrum Disorder. In two separate studies, participants were employed…

Subjective health and memory self-efficacy as mediators in the relation between subjective age and life satisfaction among older adults.

PubMed

Stephan, Yannick; Caudroit, Johan; Chalabaev, Aïna

2011-05-01

Perceiving oneself as younger than one's actual age functions as a self-enhancing positive illusion that promotes life satisfaction. However, no research has yet focused on the mechanisms through which a youthful subjective age could be related to higher life satisfaction. The purpose of this study was to identify the mediating role of resources, such as subjective health and memory self-efficacy, in the relation between subjective age and life satisfaction among older adults. A cross-sectional study was conducted with 250 older individuals aged from 60 to 77 years who completed measures of subjective age, subjective health, memory self-efficacy, and life satisfaction. Path analysis revealed that subjective age was positively related to both subjective health and memory self-efficacy, and that subjective health and memory self-efficacy were both positively related to life satisfaction. Bootstrap procedures further indicated that subjective age has significant total and specific indirect contribution to life satisfaction through subjective health and memory self-efficacy. This study fills a gap in existing literature and suggests that a youthful subjective age is associated with higher life satisfaction because it is related to higher evaluation of health and memory self-efficacy. It provides an initial support for a resource-based explanation of the relation between subjective age and life satisfaction.

The relationship between caregiving self-efficacy and depressive symptoms in family caregivers of patients with Alzheimer disease: a longitudinal study.

PubMed

Grano, Caterina; Lucidi, Fabio; Violani, Cristiano

2017-07-01

Caregiving for a relative with dementia has been associated with negative consequences for mental health. Self-efficacy has been shown to correlate negatively with depression but the long-term association between caregiver burden, caregiver self-efficacy, and depressive symptoms, remains still largely unexplored. The aim of the present study was to evaluate whether different self-efficacy domains partially mediated the relationship between caregiving burden and depression. A three-wave design was used, with initial assessment and follow-ups three months later and one year later. One hundred seventy caregivers of patients with AD responded to measures of caregiver burden, caregiving self-efficacy, and depressive symptoms. Data were analyzed by means of structural equation models. The tested model provided support for the guiding hypothesis. Burden at the time of the first assessment (T1) significantly influenced depression one year later and the relationship between burden at time one and depressive symptoms one year later was partially mediated by self-efficacy for controlling upsetting thoughts. The findings of the present study provide evidence that, along a considerable length of time, the effects of caregiver burden on depressive symptoms can be explained by the caregivers' efficacy beliefs in controlling upsetting thoughts related to the caregiving tasks. Interventions for caregivers of patients with AD may help them in tackling negative thoughts about the caregiving role.

Adaptive, dose-finding phase 2 trial evaluating the safety and efficacy of ABT-089 in mild to moderate Alzheimer disease.

PubMed

Lenz, Robert A; Pritchett, Yili L; Berry, Scott M; Llano, Daniel A; Han, Shu; Berry, Donald A; Sadowsky, Carl H; Abi-Saab, Walid M; Saltarelli, Mario D

2015-01-01

ABT-089, an α4β2 neuronal nicotinic receptor partial agonist, was evaluated for efficacy and safety in mild to moderate Alzheimer disease patients receiving stable doses of acetylcholinesterase inhibitors. This phase 2 double-blind, placebo-controlled, proof-of-concept, and dose-finding study adaptively randomized patients to receive ABT-089 (5, 10, 15, 20, 30, or 35 mg once daily) or placebo for 12 weeks. The primary efficacy endpoint was the Alzheimer's Disease Assessment Scale, cognition subscale (ADAS-Cog) total score. A Bayesian response-adaptive randomization algorithm dynamically assigned allocation probabilities based on interim ADAS-Cog total scores. A normal dynamic linear model for dose-response relationships and a longitudinal model for predicting final ADAS-cog score were employed in the algorithm. Stopping criteria for futility or success were defined. The futility stopping criterion was met, terminating the study with 337 patients randomized. No dose-response relationship was observed and no dose demonstrated statistically significant improvement over placebo on ADAS-Cog or any secondary endpoint. ABT-089 was well tolerated at all dose levels. When administered as adjunctive therapy to acetylcholinesterase inhibitors, ABT-089 was not efficacious in mild to moderate Alzheimer disease. The adaptive study design enabled the examination of a broad dose range, enabled rapid determination of futility, and reduced patient exposure to nonefficacious doses of the investigational compound.

Application of self-efficacy theory in dental clinical practice.

PubMed

Kakudate, N; Morita, M; Fukuhara, S; Sugai, M; Nagayama, M; Kawanami, M; Chiba, I

2010-11-01

In clinical practice, self-efficacy refers to how certain a patient feels about his or her ability to take the necessary action to improve the indicators and maintenance of health. It is assumed that the prognosis for patient behaviour can be improved by assessing the proficiency of their self-efficacy through providing psychoeducational instructions adapted for individual patients, and promoting behavioural change for self-care. Therefore, accurate assessment of self-efficacy is an important key in daily clinical preventive care. The previous research showed that the self-efficacy scale scores predicted patient behaviour in periodontal patients and mother's behaviour in paediatric dental practice. Self-efficacy belief is constructed from four principal sources of information: enactive mastery experience, vicarious experience, verbal persuasion, and physiological and affective states. Thus, self-efficacy can be enhanced by the intervention exploiting these sources. The previous studies revealed that behavioural interventions to enhance self-efficacy improved oral-care behaviour of patients. Therefore, assessment and enhancement of oral-care specific self-efficacy is important to promote behaviour modification in clinical dental practice. However, more researches are needed to evaluate the suitability of the intervention method. © 2010 John Wiley & Sons A/S.

[Placebo-controlled blinded study of postoperative pain therapy with carprofen and levomethadone in dogs with fractures].

PubMed

Wacker, Katja; Nolte, Ingo; Kramer, Sabine

2005-01-01

It was the aim of this placebo-controlled study to evaluate the analgesic efficacy of the NASAID carprofen and the pure m-agonist levomthadone over a five-day postoperative evaluation period in dogs with fractures of the humerus or the femur (n = 30). Pain and sedation evaluation was carried out with a visual analogues system (VAS) and with the aid of a numerical estimation scale(NRS). The degree of lameness, the pain treshhold, the glucose and cortisol concentration curves as well as the respiration and heart rate and the systolic blood pressure were used as further pain indicators and to identify drug side effects. The levomethadon group displayed the lowest degree of pain on postoperative examination on the first day. On days 2 to 5, the carprofen group showed the lowest degree of pain in comparison to the placebo group. The levomethadon- and the carprofen group showed no statistically proven differences from day 2 on. Due to great variations in the pain scores and comparatively high median pain score especially on the first day of this study, the efficacy of all analgesics evaluated here must be regarded as insufficient in many cases. Only the parameter nociceptive pain treshhold showed a little, the degree of lameness, the glucose and cortisol levels showed no close correlation to the VAS and NRS pain scores and were therefore of little usefulness as postoperative pain indicators. No relevant clinical side effects caused by the used analgesics were detected in the kidney, the liver, the gastrointestinal tract and the circulatory system in this study. Rather, traumatically induced elevation of enzyme levels improves or normalised until the 5th day of the study. In addition, no negative effect on wound healing was noted, especially for carprofen. Therefore, the evaluated analgesics seems to be adequate for postoperative pain therapy also in fracture patients (trauma patients). However, the efficacy of all analgesics evaluated here must be regarded as insufficient in many cases.

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.

Ebola Virus Infection: a review on the pharmacokinetic and pharmacodynamic properties of drugs considered for testing in human efficacy trials

PubMed Central

Madelain, Vincent; Nguyen, Thi Huyen Tram; Olivo, Anaelle; De Lamballerie, Xavier; Guedj, Jeremie; Taburet, Anne-Marie; Mentré, France

2016-01-01

The 2014–2015 outbreak of Ebola virus disease (EVD) is the largest epidemic to date in terms of number of cases, of death and affected areas. In October 2015, no antiviral agents had proven an antiviral efficacy in patients. However in September 2014 WHO inventoried and regularly updated since then a list of potential drug candidates with demonstrated antiviral efficacy in vitro or in animal models. This includes agents belonging to various therapeutic classes, namely direct antiviral agents (favipiravir and BCX4430), combination of antibodies (ZMapp), type I interferons, RNA interference-based drugs (TKM-Ebola and AVI-7537) and anticoagulant drug (rNAPc2). Here, we review the pharmacokinetic and pharmacodynamic information that are presently available on these drugs, using data obtained in healthy volunteers for pharmacokinetics and data obtained in human clinical trials or animal models for pharmacodynamics. Future studies evaluating these drugs in clinical trials will be critical to confirm their efficacy in humans, propose appropriate doses and evaluate the possibility of treatment combinations. PMID:26798032

Multiple comparisons in drug efficacy studies: scientific or marketing principles?

PubMed

Leo, Jonathan

2004-01-01

When researchers design an experiment to compare a given medication to another medication, a behavioral therapy, or a placebo, the experiment often involves numerous comparisons. For instance, there may be several different evaluation methods, raters, and time points. Although scientifically justified, such comparisons can be abused in the interests of drug marketing. This article provides two recent examples of such questionable practices. The first involves the case of the arthritis drug celecoxib (Celebrex), where the study lasted 12 months but the authors only presented 6 months of data. The second case involves the NIMH Multimodal Treatment Study (MTA) study evaluating the efficacy of stimulant medication for attention-deficit hyperactivity disorder where ratings made by several groups are reported in contradictory fashion. The MTA authors have not clarified the confusion, at least in print, suggesting that the actual findings of the study may have played little role in the authors' reported conclusions.

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.

Short report: assessing field vaccine efficacy for measles in famine-affected rural Ethiopia.

PubMed

Talley, Leisel; Salama, Peter

2003-05-01

Measles is a major cause of mortality in complex emergencies. Both high vaccination coverage and vaccine efficacy are required to prevent major epidemics of measles in such situations. Evaluation of field vaccine efficacy is a critical but underutilized component of program monitoring in emergencies, and is particularly important in rural areas where the integrity of the cold chain is difficult to guarantee. In July 2000, we evaluated the field vaccine efficacy for measles vaccination by comparing the incidence of cases in vaccinated and unvaccinated groups during a two-stage cluster survey of 563 children in Ethiopia. Approximately 30% of the measles cases occurred in vaccinated children. Estimated field vaccine efficacy for measles was 66.9% in children 9-36 months old. The finding of a field vaccine efficacy for measles less than 80% warrants formal assessment of measles vaccine efficacy, particularly in famine emergencies where measles is associated with a high case fatality rate.

Technology efficacy in active prosthetic knees for transfemoral amputees: a quantitative evaluation.

PubMed

El-Sayed, Amr M; Hamzaid, Nur Azah; Abu Osman, Noor Azuan

2014-01-01

Several studies have presented technological ensembles of active knee systems for transfemoral prosthesis. Other studies have examined the amputees' gait performance while wearing a specific active prosthesis. This paper combined both insights, that is, a technical examination of the components used, with an evaluation of how these improved the gait of respective users. This study aims to offer a quantitative understanding of the potential enhancement derived from strategic integration of core elements in developing an effective device. The study systematically discussed the current technology in active transfemoral prosthesis with respect to its functional walking performance amongst above-knee amputee users, to evaluate the system's efficacy in producing close-to-normal user performance. The performances of its actuator, sensory system, and control technique that are incorporated in each reported system were evaluated separately and numerical comparisons were conducted based on the percentage of amputees' gait deviation from normal gait profile points. The results identified particular components that contributed closest to normal gait parameters. However, the conclusion is limitedly extendable due to the small number of studies. Thus, more clinical validation of the active prosthetic knee technology is needed to better understand the extent of contribution of each component to the most functional development.

Evaluation of efficacy of a pulse oximeter to assess pulp vitality.

PubMed

Sadique, Mohammed; Ravi, S V; Thomas, Kunjamma; Dhanapal, Prasanth; Simon, Elsy P; Shaheen, Mohammed

2014-06-01

To evaluate the efficacy of pulse oximeter as a pulp vitality tester. The sample group consisted of 60 patients of age 15 to 30 years with normal maxillary anterior teeth. Thirty nonvital teeth with complete endodontic fillings were tested as control group. Systemic oxygen saturation values from the patient's fingers served as the control sample for comparison of pulp oxygen saturation values. Readings were recorded on index fingers first; teeth were then evaluated by placing sensor onto the tooth. Nonvital teeth recorded oxygen saturation values of 0%. The mean value for central incisor was 85.11 (SD ± 2.07), for lateral incisors 80.21 (SD ± 2.03) and for canines 89.55 (SD ± 1.09). Their control values (patient's index fingers) averaged 95.88% (SD ± 0.66). Pearson's correlation analysis showed a correlation of 0.11 for central incisors, 0.19 for lateral incisors and 0.12 for canines. This study confirms that pulse oximeter is effective equipment for pulp vitality testing. Pulse oximeter evidences the actual method of evaluating the pulp vitality compared to contemporary methods. How to cite the article: Sadique M, Ravi SV, Thomas K, Dhanapal P, Simon EP, Shaheen M. Evaluation of efficacy of a pulse oximeter to assess pulp vitality. J Int Oral Health 2014;6(3):70-2.

IMITS: Information and Clinical Technologies for the Advancement of Healthcare

DTIC Science & Technology

2008-12-01

a model to evaluate the efficacy of Platelet Gel Therapy on non-healing diabetic foot wounds... the safety and efficacy of Platelet Gel Therapy on non-healing diabetic lower extremity wounds. The implementation of the study protocol, “ A Randomized...prototype for select MTFs. One of the initial steps within Phase Two will be for the DWA project team to provide a project review at SGR

Evaluation of efficacy, potential for vector transmission and duration of immunity testing of MP-12, an attenuated Rift Valley fever virus vaccine candidate, in sheep

USDA-ARS?s Scientific Manuscript database

Rift Valley fever virus (RVFV) causes serious disease in ruminants and humans in Africa. There are currently no fully licensed vaccines for this arthropod-borne virus in the US. Studies in sheep and cattle have found an attenuated strain of RVFV, MP-12, to be both safe and efficacious, and a conditi...

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

Psychological Neuromodulatory Treatments for Young People with Chronic Pain

PubMed Central

Miró, Jordi; Castarlenas, Elena; de la Vega, Rocío; Roy, Rubén; Solé, Ester; Tomé-Pires, Catarina; Jensen, Mark P.

2016-01-01

The treatment of young people with chronic pain is a complex endeavor. Many of these youth do not obtain adequate relief from available interventions. Psychological neuromodulatory treatments have been shown to have potential benefit for adults with chronic pain. Here, we review and summarize the available information about the efficacy of three promising psychological neuromodulatory treatments—neurofeedback, meditation and hypnosis—when provided to young people with chronic pain. A total of 16 articles were identified and reviewed. The findings from these studies show that hypnotic treatments are effective in reducing pain intensity for a variety of pediatric chronic pain problems, although research suggests variability in outcomes as a function of the specific pain problem treated. There are too few studies evaluating the efficacy of neurofeedback or meditation training in young people with chronic pain to draw firm conclusions regarding their efficacy. However, preliminary data indicate that these treatments could potentially have positive effects on a variety of outcomes (e.g., pain intensity, frequency of pain episodes, physical and psychological function), at least in the short term. Clinical trials are needed to evaluate the effects of neurofeedback and meditation training, and research is needed to identify the moderators of treatment benefits as well as better understand the mechanisms underlying the efficacy of all three of these treatments. The findings from such research could enhance overall treatment efficacy by: (1) providing an empirical basis for better patient-treatment matching; and (2) identifying specific mechanisms that could be targeted with treatment. PMID:27929419

Efficacy of a food supplement in patients with hashimoto thyroiditis.

PubMed

Nordio, M; Basciani, S

2015-01-01

Thyroid inflammation has been commonly seen in recent decades, due to a series of factors and is considered as the most frequent thyroid illness. It is characterized by some distinctive traits, which include morphological and hormonal modifications, often in association with an elevated anti-thyroid autoantibody title. The aim of the therapy is to improve symptoms as fast as possible, treating inflammation and subsequent hypothyroidism, when present. Therefore, we evaluated the efficacy of a Food Supplement (FS) containing enzymes which is commonly used in various inflammatory processes and is able to modulate immune reactions during inflammation in a very rapid and efficacious way. An open, controlled study was then designed and 45 patients with Hashimoto thyroiditis were enrolled and divided into 3 groups (FS alone; thyroid hormones alone; FS plus thyroid hormones). Blood, morphological and subjective parameters were considered. The results obtained indicate that the FS used in our study is efficacious and safe when used alone and/or in combination with thyroid hormones in the treatment of autoimmune thyroiditis, as documented by the improvement of the majority of the parameters considered. The efficacy was considered faster than thyroid hormones alone as far as subjective symptomatology is considered. In conclusion, the use of the food supplement evaluated herein during inflammation may be considered an additional tool in clinicians’ hands, when facing patients with autoimmune thyroiditis, especially in presence of subjective symptomatology, in order to rapidly alleviate it.

Topical microbicide use by adolescent girls: concerns about timing, efficacy, and safety.

PubMed

Short, Mary B; Mills, Lisa; Majkowski, Jasmine M; Stanberry, Lawrence R; Rosenthal, Susan L

2003-11-01

Adolescent girls could benefit from topical microbicide use if the product is acceptable to them. The goal was to evaluate girls', mothers', experienced healthcare providers', and medical students' views on timing of use, efficacy, and safety of topical microbicide use by adolescents. Focus groups were conducted with girls, mothers, healthcare providers, and medical students. All groups were videotaped, transcribed, and coded for relevant themes. A delay between insertion and coitus presented a problem, and pre- and postcoital use had advantages depending on the group. Efficacy was evaluated by timing of use, smell, ability to feel the product, and confidence that it would spread sufficiently. There were concerns about physical side effects and the impact on normal vaginal flora. This study demonstrated the importance of understanding the unique needs and perspectives of adolescent girls and the adults who have an influence on their use.

Evaluation of antimicrobial efficacy of Aloe vera and its effectiveness in decontaminating gutta percha cones.

PubMed

Athiban, Prakash P; Borthakur, Bikash Jyoti; Ganesan, S; Swathika, B

2012-07-01

The aim of this study was to evaluate the antimicrobial efficacy of Aloe vera and to determine its effectiveness in decontaminating gutta percha cones. A concentrated extract of Aloe vera was used to check for the antimicrobial efficacy using the agar well diffusion method. Presence of zones' of diffusion was identified against three common GP contaminants namely, E.coli, E.faecalis and Staph. aureus. New GP Cones, freshly taken out of the packet were then decontaminated for 1minute using Aloe vera gel and then placed in thioglycolate broth to check for the presence of turbidity. The zones of inhibition on the agar plate were measured as 24mm,21mm and 24mm respectively. The broth remained clear even after 48 hours of incubation. We conclude that Aloe vera is indeed effective as a GP decontaminant and it holds a promising future as a medium for storage of GP cones.

Efficacy of aprotinin with various anticoagulant agents in cardiopulmonary bypass.

PubMed

Terrell, M R; Walenga, J M; Koza, M J; Pifarré, R

1996-08-01

Aprotinin has recently been approved for clinical use in cardiopulmonary bypass. Although unfractionated heparin has been the only anticoagulant widely used for cardiopulmonary bypass, disadvantages involving heparin have led to ongoing investigations of alternative anticoagulant agents. The objective of this study was to evaluate the efficacy of aprotinin in combination with other anticoagulant agents, specifically low molecular weight heparin and recombinant hirudin, using a dog model of cardiopulmonary bypass. The blood conservation resulting from the use of aprotinin was observed only with unfractionated heparin. Efficacy of anticoagulation as measured by protein deposits in the bypass circuit filter revealed an unexpected reduction in the quantity of deposits when aprotinin was used in combination with low molecular weight heparin. As alternative anticoagulant agents are sought, the potential benefits of aprotinin in the reduction of operative blood loss must be evaluated independently for each anticoagulant agent.