Analysis of Social Problem Solving and Social Self-Efficacy in Prospective Teachers

ERIC Educational Resources Information Center

Erozkan, Atilgan

2014-01-01

The purpose of this study is to investigate the relationship between social problem solving and social selfefficacy and the predictive role of social problem solving skills with social self-efficacy. The sample consists of 706 prospective teachers (362 female and 344 male) who are majoring in different fields at Mugla Sitki Kocman University's…

Are Prospective Elementary School Teachers' Social Studies Teaching Efficacy Beliefs Related to Their Learning Approaches in a Social Studies Teaching Methods Course?

ERIC Educational Resources Information Center

Dündar, Sahin

2015-01-01

This study aimed to contribute to the growing literature on learning approaches and teacher self-efficacy beliefs by examining associations between prospective elementary school teachers' learning approaches in a social studies teaching methods course and their social studies teaching efficacy beliefs. One hundred ninety-two prospective elementary…

The Relationship between Attitudes of Prospective Physical Education Teachers towards Education Technologies and Computer Self-Efficacy Beliefs

ERIC Educational Resources Information Center

Kalemoglu Varol, Yaprak

2014-01-01

The aim of research is to investigate the relationship between attitudes of prospective physical education teacher towards education technologies and their computer self-efficacy beliefs. Relational research method has been used in the study. Study group consists of 337 prospective physical education teachers ("M"[subscript age] = 21.57…

An Investigation into Prospective Science Teachers' Attitudes towards Laboratory Course and Self-Efficacy Beliefs in Laboratory Use

ERIC Educational Resources Information Center

Aka, Elvan Ince

2016-01-01

The aim of the current study is to identify the attitudes towards the laboratory course and self-efficacy beliefs in the laboratory use of prospective teachers who are attending Gazi University Gazi Education Faculty Primary Education Science Teaching program, and to investigate the relationship between the attitudes and self-efficacy beliefs.…

Development of an Instrument to Assess Prospective Elementary Teacher Self-Efficacy Beliefs about Equitable Science Teaching and Learning (SEBEST)

NASA Astrophysics Data System (ADS)

Ritter, Jennifer M.; Boone, William J.; Rubba, Peter A.

2001-06-01

This paper presents an overview of the procedures used to develop and validate an instrument to measure the self-efficacy beliefs of prospective elementary teachers about equitable science teaching and learning. The instrument, titled the SEBEST, was based on the work of Ashton and Webb (1986a, 1986b) and Bandura (1977, 1986). It was modeled after the Science Teaching Efficacy Belief Instrument (STEBI) (Riggs, 1988) and the Science Teaching Efficacy Belief Instrument for Prospective Teachers (STEBI-B) (Enochs & Riggs, 1990). Based on the standardized development procedures used and associated evidence, the SEBEST appears to be a content and construct valid instrument, with high internal reliability qualities. "Most probable response" plots are introduced and used to bring meaning to SEBEST raw scores.

Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort.

PubMed

Gecse, Krisztina B; Lovász, Barbara D; Farkas, Klaudia; Banai, János; Bene, László; Gasztonyi, Beáta; Golovics, Petra Anna; Kristóf, Tünde; Lakatos, László; Csontos, Ágnes Anna; Juhász, Márk; Nagy, Ferenc; Palatka, Károly; Papp, Mária; Patai, Árpád; Lakner, Lilla; Salamon, Ágnes; Szamosi, Tamás; Szepes, Zoltán; Tóth, Gábor T; Vincze, Áron; Szalay, Balázs; Molnár, Tamás; Lakatos, Péter L

2016-02-01

Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

[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.

Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

PubMed

Pierot, Laurent; Moret, Jacques; Barreau, Xavier; Szikora, Istvan; Herbreteau, Denis; Turjman, Francis; Holtmannspötter, Markus; Januel, Anne-Christine; Costalat, Vincent; Fiehler, Jens; Klisch, Joachim; Gauvrit, Jean-Yves; Weber, Werner; Desal, Hubert; Velasco, Stéphane; Liebig, Thomas; Stockx, Luc; Berkefeld, Joachim; Molyneux, Andrew; Byrne, James; Spelle, Laurent

2018-06-01

Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy. To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2. WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%. This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment. French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function.

PubMed

Jacques, Jérémie; Pagnon, Lauriane; Hure, Florent; Legros, Romain; Crepin, Sabrina; Fauchais, Anne-Laure; Palat, Sylvain; Ducrotté, Philippe; Marin, Benoit; Fontaine, Sebastien; Boubaddi, Nour Edine; Clement, Marie-Pierre; Sautereau, Denis; Loustaud-Ratti, Veronique; Gourcerol, Guillaume; Monteil, Jacques

2018-06-12

 Gastroparesis is a functional disorder with a variety of symptoms that is characterized by delayed gastric emptying in the absence of mechanical obstruction. A recent series of retrospective studies has demonstrated that peroral endoscopic pyloromyotomy (G-POEM) is a promising endoscopic procedure for treating patients with refractory gastroparesis. The aim of this prospective study was to evaluate the feasibility, safety, and efficacy of G-POEM.  20 patients with refractory gastroparesis (10 diabetic and 10 nondiabetic) were prospectively included in the trial. Patients were treated by G-POEM after evaluation of pyloric function using an endoscopic functional luminal imaging probe. Clinical responses were evaluated using the Gastroparesis Cardinal Symptom Index (GCSI), and quality of life was assessed using the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life scale and the Gastrointestinal Quality of Life Index scores. Gastric emptying was measured using 4-hour scintigraphy before G-POEM and at 3 months.  Feasibility of the procedure was 100 %. Compared with baseline values, G-POEM significantly improved symptoms (GCSI: 1.3 vs. 3.5; P  < 0.001), quality of life, and gastric emptying (T½: 100 vs. 345 minutes, P  < 0.001; %H2: 56.0 % vs. 81.5 %, P  < 0.001; %H4: 15.0 % vs. 57.5 %, P  = 0.003) at 3 months. The clinical success of G-POEM using the functional imaging probe inflated to 50 mL had specificity of 100 % and sensitivity of 72.2 % ( P  = 0.04; 95 % confidence interval 0.51 - 0.94; area under the curve 0.72) at a distensibility threshold of 9.2 mm 2 /mmHg.  G-POEM was efficacious and safe for treating refractory gastroparesis, especially in patients with low pyloric distensibility. © Georg Thieme Verlag KG Stuttgart · New York.

The development and validation of the Self-Efficacy Beliefs about Equitable Science Teaching and learning instrument for prospective elementary teachers

NASA Astrophysics Data System (ADS)

Ritter, Jennifer M.

1999-12-01

The purpose of this study was to develop, validate and establish the reliability of an instrument to assess the self-efficacy beliefs of prospective elementary teachers with regards to science teaching and learning for diverse learners. The study used Bandura's theoretical framework, in that the instrument would use the self-efficacy construct to explore the beliefs of prospective elementary science teachers with regards to science teaching and learning to diverse learners: specifically the two dimensions of self-efficacy beliefs defined by Bandura (1977): personal self-efficacy and outcome expectancy. A seven step plan was designed and followed in the process of developing the instrument, which was titled the Self-Efficacy Beliefs about Equitable Science Teaching or SEBEST. Diverse learners as recognized by Science for All Americans (1989) are "those who in the past who have largely been bypassed in science and mathematics education: ethnic and language minorities and girls" (p. xviii). That definition was extended by this researcher to include children from low socioeconomic backgrounds based on the research by Gomez and Tabachnick (1992). The SEBEST was administered to 226 prospective elementary teachers at The Pennsylvania State University. Using the results from factor analyses, Coefficient Alpha, and Chi-Square a 34 item instrument was found to achieve the greatest balance across the construct validity, reliability and item balance with the content matrix. The 34 item SEBEST was found to load purely on four factors across the content matrix thus providing evidence construct validity. The Coefficient Alpha reliability for the 34 item SEBEST was .90 and .82 for the PSE sub-scale and .78 for the OE sub-scale. A Chi-Square test (X2 = 2.7 1, df = 7, p > .05) was used to confirm that the 34 items were balanced across the Personal Self-Efficacy/Outcome Expectancy and Ethnicity/LanguageMinority/Gender Socioeconomic Status/dimensions of the content matrix. Based on

Turkish Prospective Middle School Mathematics Teachers' Beliefs and Perceived Self-Efficacy Beliefs Regarding the Use of Origami in Mathematics Education

ERIC Educational Resources Information Center

Arslan, Okan; Isiksal-Bostan, Mine

2016-01-01

The purpose of this study was to investigate beliefs and perceived self-efficacy beliefs of Turkish prospective elementary mathematics teachers in using origami in mathematics education. Furthermore, gender differences in their beliefs and perceived self-efficacy beliefs were investigated. Data for the current study was collected via Origami in…

Emotional Intelligence, Self-Efficacy, and Coping among Chinese Prospective and In-Service Teachers in Hong Kong

ERIC Educational Resources Information Center

Chan, David W.

2008-01-01

Emotional intelligence (intrapersonal and interpersonal) and general teacher self-efficacy were assessed to represent personal resources facilitating active and passive coping in a sample of 273 Chinese prospective and in-service teachers in Hong Kong. Intrapersonal emotional intelligence and interpersonal emotional intelligence were found to…

A Review of Relationship between Prospective Science Teachers' Attitudes towards Science Education and Their Self-Efficacy

ERIC Educational Resources Information Center

Türer, Betül; Kunt, Halil

2015-01-01

In this research, we aim to review relationship between prospective science teachers' attitudes against science education (physics, chemistry, biology, laboratory) and their self-efficacy. Population of the research constitutes 497 students studying Science Education in Department of Elementary Education in Celal Bayar University Faculty of…

Efficacy and Safety of Methadone as a Second-Line Opioid for Cancer Pain in an Outpatient Clinic: A Prospective Open-Label Study

PubMed Central

Garzón-Rodríguez, Cristina; Villavicencio-Chávez, Christian; Llorens-Torromé, Silvia; González-Barboteo, Jesús

2016-01-01

Introduction. Most clinical reports on methadone rotation describe outcomes in hospitalized patients. The few studies that have included outpatients are retrospective. The aim of this study was to assess the efficacy and safety of methadone as a second-line opioid in adult patients with advanced cancer after rotation in routine clinical practice at a palliative care outpatient clinic. Patients and Methods. This was a prospective, open-label study of 145 patients whose treatment was rotated from other opioids to methadone. Informed consent was obtained in all cases. The main outcome measure was change in the variable “worst pain” at day 28. Pain and pain interference were assessed with the Brief Pain Inventory, with side effects evaluated according to the Common Terminology Criteria for Adverse Events version 3.0. Pain levels were evaluated at study entry and at days 3, 7, 9, 14, 21, and 28. Results. Rotation to methadone was performed for the following reasons: poor pain control (77.9%), opioid side effects (2.1%), or both (20%). The mean daily oral morphine equivalent dose before rotation was 193.7 mg. The median worst and average pain scores decreased significantly (p < .0001) from baseline to day 28: The median worst pain score decreased from 9 (interquartile range [IQR]: 8–10) to 6 (IQR: 3–8), and the median average pain score decreased from 6 (IQR: 5–7) to 4 (IQR: 2–5). The proportions of patients with moderate to severe worst and average pain decreased by 30.3% and 47.5%, respectively, by day 28. No increase in opioid toxicity was observed during the study. Conclusion. In outpatients with advanced cancer, rotation to methadone as a second-line opioid was efficacious and safe when using a tiered scheme with close follow-up by experienced health professionals. Implications for Practice: The results of this study, conducted prospectively under real clinical conditions, support the efficacy and safety of oral methadone as a second-line opioid in

Characterization of Mathematics Instructional Practises for Prospective Elementary Teachers with Varying Levels of Self-Efficacy in Classroom Management and Mathematics Teaching

ERIC Educational Resources Information Center

Lee, Carrie W.; Walkowiak, Temple A.; Nietfeld, John L.

2017-01-01

The purpose of this study was to investigate the relationship between prospective teachers' (PTs) instructional practises and their efficacy beliefs in classroom management and mathematics teaching. A sequential, explanatory mixed-methods design was employed. Results from efficacy surveys, implemented with 54 PTs were linked to a sample of…

Efficacy of Magnesium Trihydrate of Ursodeoxycholic Acid and Chenodeoxycholic Acid for Gallstone Dissolution: A Prospective Multicenter Trial.

PubMed

Hyun, Jong Jin; Lee, Hong Sik; Kim, Chang Duck; Dong, Seok Ho; Lee, Seung-Ok; Ryu, Ji Kon; Lee, Don Haeng; Jeong, Seok; Kim, Tae Nyeun; Lee, Jin; Koh, Dong Hee; Park, Eun Taek; Lee, In-Seok; Yoo, Byung Moo; Kim, Jin Hong

2015-07-01

Cholecystectomy is necessary for the treatment of symptomatic or complicated gallbladder (GB) stones, but oral litholysis with bile acids is an attractive alternative therapeutic option for asymptomatic or mildly symptomatic patients. This study was conducted to evaluate the efficacy of magnesium trihydrate of ursodeoxycholic acid (UDCA) and chenodeoxycholic acid (CDCA) on gallstone dissolution and to investigate improvements in gallstone-related symptoms. A prospective, multicenter, phase 4 clinical study to determine the efficacy of orally administered magnesium trihydrate of UDCA and CDCA was performed from January 2011 to June 2013. The inclusion criteria were GB stone diameter ≤15 mm, GB ejection fraction ≥50%, radiolucency on plain X-ray, and asymptomatic/mildly symptomatic patients. The patients were prescribed one capsule of magnesium trihydrate of UDCA and CDCA at breakfast and two capsules at bedtime for 6 months. The dissolution rate, response rate, and change in symptom score were evaluated. A total of 237 subjects were enrolled, and 195 subjects completed the treatment. The dissolution rate was 45.1% and the response rate was 47.2% (92/195) after 6 months of administration of magnesium trihydrate of UDCA and CDCA. Only the stone diameter was significantly associated with the response rate. Both the symptom score and the number of patients with symptoms significantly decreased regardless of stone dissolution. Adverse events necessitating discontinuation of the drug, surgery, or endoscopic management occurred in 2.5% (6/237) of patients. Magnesium trihydrate of UDCA and CDCA is a well-tolerated bile acid that showed similar efficacy for gallstone dissolution and improvement of gallstone-related symptoms as that shown in previous studies.

An evaluation of biodegradable synthetic polyurethane foam in patients following septoplasty: a prospective randomized trial.

PubMed

Yilmaz, Mahmut Sinan; Guven, Mehmet; Elicora, Sultan Sevik; Kaymaz, Recep

2013-01-01

The purpose of this study is to examine the usability of biodegradable synthetic polyurethane foam (BSPF) after septoplasty by comparing it with Merocel and silicone intranasal splints as packing materials in terms of patient comfort and efficiency. A prospective, unmasked, randomized trial. A tertiary referral center. This study was designed to be a prospective, randomized clinical trial. Sixty-eight patients who underwent septoplasty were included in this study. The patients were randomized to receive Merocel, silicone intranasal septal splint (INS), or BSPF after septoplasty. Clinical efficacy on bleeding, pain, and subjective symptoms related to packing materials was evaluated. There was a statistically significant difference between the Merocel group and the other 2 groups in terms of bleeding and adhesion. The average score on the pain scale was 2.47 ± 1.01 for BSPF, 3.68 ± 1.27 for INS, and 6 ± 2.21 for Merocel. Scores on general satisfaction scales were 6.95 ± 1.42 for Merocel, 8.44 ± 2.12 for INS, and 8.28 ± 1.88 for BSPF. The efficacy of BSPF was comparable with that of Merocel and INS. Biodegradable synthetic polyurethane foam significantly reduced pain and patient discomfort during packing and removal, followed by INS, compared with Merocel.

Efficacy of noninvasive evaluations in monitoring inflammatory bowel disease activity: A prospective study in China

PubMed Central

Chen, Jin-Min; Liu, Tao; Gao, Shan; Tong, Xu-Dong; Deng, Fei-Hong; Nie, Biao

2017-01-01

AIM To optimize the efficacy of noninvasive evaluations in monitoring the endoscopic activity of inflammatory bowel disease (IBD). METHODS Fecal calprotectin (FC), clinical activity index (CDAI or CAI), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and procalcitonin (PCT) were measured for 136 IBD patients. Also, FC was measured in 25 irritable bowel syndrome (IBS) patients that served as controls. Then, endoscopic activity was determined by other two endoscopists for colonic or ileo-colonic Crohn’s disease (CICD) with the “simple endoscopic score for Crohn’s disease” (SES-CD), CD-related surgery patients with the Rutgeerts score, and ulcerative colitis (UC) with the Mayo score. The efficacies of these evaluations to predict the endoscopic disease activity were assessed by Mann-Whitney test, χ2 test, Spearman’s correlation, and multiple linear regression analysis. RESULTS The median FC levels in CD, UC, and IBS patients were 449.6 (IQR, 137.9-1344.8), 497.9 (IQR, 131.7-118.0), and 9.9 (IQR, 049.7) μg/g, respectively (P < 0.001). For FC, CDAI or CAI, CRP, and ESR differed significantly between endoscopic active and remission in CICD and UC patients, but not in CD-related surgery patients. The SES-CD correlated closely with levels of FC (r = 0.802), followed by CDAI (r = 0.734), CRP (r = 0.658), and ESR (r = 0.557). The Mayo score also correlated significantly with FC (r = 0.837), CAI (r = 0.776), ESR (r = 0.644), and CRP (r = 0.634). For FC, a cut-off value of 250 μg/g indicated endoscopic active inflammation with accuracies of 87.5%, 60%, and 91.1%, respectively, for CICD, CD-related surgery, and UC patients. Moreover, clinical FC activity (CFA) calculated as 0.8 × FC + 4.6 × CDAI showed higher area under the curve (AUC) of 0.962 for CICD and CFA calculated as 0.2 × FC + 50 × CAI showed higher AUC (0.980) for UC patients than the FC. Also, the diagnostic accuracy of FC in identifying patients with mucosal inflammation in clinical

Burnout, Self-Efficacy, and Successful Intelligence among Chinese Prospective and In-Service School Teachers in Hong Kong

ERIC Educational Resources Information Center

Chan, David W.

2007-01-01

This study assessed the three components of burnout (emotional exhaustion, depersonalisation, and reduced personal accomplishment), perceived self-efficacy, and the three triarchic abilities (analytical, synthetic, and practical) of successful intelligence in a sample of 267 Chinese prospective and in-service teachers in Hong Kong. The aim was to…

Prospective study of vaginal dilator use adherence and efficacy following radiotherapy

PubMed Central

Law, Ethel; Kelvin, Joanne F.; Thom, Bridgette; Riedel, Elyn; Tom, Ashlyn; Carter, Jeanne; Alektiar, Kaled; Goodman, Karyn A.

2016-01-01

Background and purpose Vaginal stenosis (VS) after pelvic radiotherapy can impair long-term quality of life. We prospectively assessed adherence and efficacy of VD use as the primary and secondary objectives, respectively. Material and methods Women with gastrointestinal (n=63) and gynecologic (n=46) cancers self-reported use and VD size in monthly diaries for 12 months after radiotherapy. Adherence was measured as actual VD use out of recommended times over 12 months (3×/week × 52 weeks = 156). Results Among 109 participants, aged 28–81 years (median, 58 years), mean percent adherence over 12 months was 42% (95% confidence interval [CI], 36%–48%). Adherence was highest in the first quarter (56%), but fell to 25% by the fourth. Disease type, treatment sequence, and chemotherapy were predictors of adherence (all P<.05). Eighty-two percent maintained pre-RT VD size at 12 months; of 49% with decrease in VD size at 1 month post-RT, 71% returned to pre-RT VD size at 12 months. Disease type, younger age, and increased adherence at 6 months were associated with maintaining or returning to pre-RT size at 12 months (all P≤.05). Conclusions VD use is effective in minimizing VS, but adherence at 12 months was poor. Studies evaluating methods of improving adherence and determining the optimal frequency and duration of use are needed. PMID:26164775

Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.

PubMed

Sugimoto, Shinya; Naganuma, Makoto; Kiyohara, Hiroki; Arai, Mari; Ono, Keiko; Mori, Kiyoto; Saigusa, Keiichiro; Nanki, Kosaku; Takeshita, Kozue; Takeshita, Tatsuya; Mutaguchi, Makoto; Mizuno, Shinta; Bessho, Rieko; Nakazato, Yoshihiro; Hisamatsu, Tadakazu; Inoue, Nagamu; Ogata, Haruhiko; Iwao, Yasushi; Kanai, Takanori

2016-01-01

Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted. © 2016 S. Karger AG, Basel.

[A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

PubMed

Lu, Quan

2010-03-01

To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P < 0.05) and except nasal congestion, the efficacy in all the other symptoms of trial group was better than that in the control group as well on the 7th day (P < 0.01). The improvement rate for combined symptoms of Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

Assessment of the Efficacy of Cryolipolysis on Saddlebags: A Prospective Study of 53 Patients.

PubMed

Adjadj, Lucille; SidAhmed-Mezi, Mounia; Mondoloni, Marine; Meningaud, Jean Paul; Hersant, Barbara

2017-07-01

Cryolipolysis is a noninvasive subcutaneous fat removal technique. Its efficacy has been demonstrated on various fatty areas but not yet on saddlebags. The main objective of this study was to demonstrate the efficacy, patient tolerance, and safety of cryolipolysis on the saddlebags. This prospective study enrolled 53 patients with saddlebags. Patients with a history of liposuction or other surgical procedure on the saddlebag area and those on diet pills were excluded. The primary endpoint was a decrease in fat thickness at 3 and 6 months, as assessed by thigh circumference measurement and by ultrasound evaluation of subcutaneous fat. Pain associated with cryolipolysis was assessed using a visual analogue scale. Body mass index at the different time points and adverse events were recorded. All patients completed a satisfaction questionnaire at the end of the study. At 6 months, there was a mean decrease of 5.63 cm in thigh circumference; the mean decrease in fat layer thickness measured by ultrasound was 1.31 cm. The satisfaction questionnaire showed that 93.75 percent of patients were satisfied with the results. The mean visual analogue scale score was 1.66 of 10 after the session. Reversible skin changes such as postprocedure postinflammatory hyperpigmentation were observed in 8.33 percent of patients. Cryolipolysis is an effective technique for reducing saddlebag fat and is well tolerated by patients. A substantial risk of skin lesions, including postinflammatory hyperpigmentation that resolved after a few months, was observed. Cryolipolysis is a good alternative to liposuction in women with moderate, well-localized saddlebags. Therapeutic, IV.

The efficacy of the modified Atkins diet in North Sea Progressive Myoclonus Epilepsy: an observational prospective open-label study.

PubMed

van Egmond, Martje E; Weijenberg, Amerins; van Rijn, Margreet E; Elting, Jan Willem J; Gelauff, Jeannette M; Zutt, Rodi; Sival, Deborah A; Lambrechts, Roald A; Tijssen, Marina A J; Brouwer, Oebele F; de Koning, Tom J

2017-03-07

North Sea Progressive Myoclonus Epilepsy is a rare and severe disorder caused by mutations in the GOSR2 gene. It is clinically characterized by progressive myoclonus, seizures, early-onset ataxia and areflexia. As in other progressive myoclonus epilepsies, the efficacy of antiepileptic drugs is disappointingly limited in North Sea Progressive Myoclonus Epilepsy. The ketogenic diet and the less restrictive modified Atkins diet have been proven to be effective in other drug-resistant epilepsy syndromes, including those with myoclonic seizures. Our aim was to evaluate the efficacy of the modified Atkins diet in patients with North Sea Progressive Myoclonus Epilepsy. Four North Sea Progressive Myoclonus Epilepsy patients (aged 7-20 years) participated in an observational, prospective, open-label study on the efficacy of the modified Atkins diet. Several clinical parameters were assessed at baseline and again after participants had been on the diet for 3 months. The primary outcome measure was health-related quality of life, with seizure frequency and blinded rated myoclonus severity as secondary outcome measures. Ketosis was achieved within 2 weeks and all patients completed the 3 months on the modified Atkins diet. The diet was well tolerated by all four patients. Health-related quality of life improved considerably in one patient and showed sustained improvement during long-term follow-up, despite the progressive nature of the disorder. Health-related quality of life remained broadly unchanged in the other three patients and they did not continue the diet. Seizure frequency remained stable and blinded rating of their myoclonus showed improvement, albeit modest, in all patients. This observational, prospective study shows that some North Sea Progressive Myoclonus Epilepsy patients may benefit from the modified Atkins diet with sustained health-related quality of life improvement. Not all our patients continued on the diet, but nonetheless we show that the modified

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.

[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.

MR imaging of silicone breast implants: evaluation of prospective and retrospective interpretations and interobserver agreement.

PubMed

Quinn, S F; Neubauer, N M; Sheley, R C; Demlow, T A; Szumowski, J

1996-01-01

MR imaging was used to evaluate the integrity of silicone breast implants in 54 women with 108 implants. MR images were interpreted by relatively inexperienced readers who tried to reproduce the experiences reported in the literature. The study examines the interobserver agreement using different diagnostic signs and the influence of experience on interpretation errors. Prospective and retrospective interpretations were compared with surgical findings at the time of explanation. Diagnostic indicators, including the linguine sign, the inverted tear drop sign, the C sign, water droplets mixed with silicone, and extracapsular globules of silicone, were evaluated for diagnostic efficacy and interobserver agreement. The prospective sensitivity and specificity were 87% and 78%, respectively. With the retrospective interpretations, the sensitivity and specificity increased to 93% and 92%, respectively. Most of the prospective false-positive interpretations were due to misinterpreting radial folds as signs of implant rupture. Six implants interpreted retrospectively as false positives had gross amounts of silicone around the implants at surgery but there were no obvious rents in the implant shells. There was fair to excellent interobserver agreement with the individual diagnostic signs except for extracapsular globules of silicone. All of the signs had specificities of greater than 90%. The sensitivities of the individual signs were less than the overall retrospective sensitivity. With experience, the sensitivity improved from 87% to 93% and the specificity improved from 78% to 92%. This study helps substantiate the use of diagnostic signs used by other authors to detect silicone loss from breast implants by MR imaging; however, questions remain as to the clinical role of MR imaging in evaluating implants for silicone loss.

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.

[Immunological surrogate endpoints to evaluate vaccine efficacy].

PubMed

Jin, Pengfei; Li, Jingxin; Zhou, Yang; Zhu, Fengcai

2015-12-01

An immunological surrogate endpoints is a vaccine-induced immune response (either humoral or cellular immune) that predicts protection against clinical endpoints (infection or disease), and can be used to evaluate vaccine efficacy in clinical vaccine trials. Compared with field efficacy trials observing clinical endpoints, immunological vaccine trials could reduce the sample size or shorten the duration of a trial, which promote the license and development of new candidate vaccines. For these reasons, establishing immunological surrogate endpoints is one of 14 Grand Challenges of Global Health of the National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation. From two parts of definition and statistical methods for evaluation of surrogate endpoints, this review provides a more comprehensive description.

An open-label, prospective clinical study to evaluate the efficacy and safety of TLPL/AY/01/2008 in the management of functional constipation

PubMed Central

Munshi, Renuka; Bhalerao, Supriya; Rathi, Pravin; Kuber, V. V.; Nipanikar, S. U.; Kadbhane, K. P.

2011-01-01

Functional constipation is one of the most common gastrointestinal symptoms across the globe. Its high prevalence rate, economic burden, and adverse implications on the quality of life make constipation a major public health issue. Though various treatment options are available for the management of constipation, evidence for their efficacy and safety are limited. An open-label, prospective, interventional, and exploratory clinical trial was carried out to evaluate the efficacy and safety of “TLPL/AY/01/2008” in 34 patients suffering from functional constipation. “TLPL/AY/01/2008” is an Ayurvedic proprietary polyherbal formulation in powder form, containing Isabgol husk, Senna extract, and Triphala extract. Administration of “TLPL/AY/01/2008” for 14 days showed a significant increase in mean weekly bowel movements from 10.19 ± 05.64 to 18.29 ± 05.72 (P<0.05). The mean average time spent on toilet for bowel evacuation reduced significantly from 11.02 ± 05.43 minutes (baseline value) to 08.70 ± 04.72 minutes on day 14 (P<0.05). Mean stool form score assessed on Bristol stool form scale was improved from 02.97 ± 00.48 (baseline value) to 04.61 ± 00.84 (P<0.05) on day 14. A significant improvement (P<0.05) was also noted in straining during defecation, sensation of incomplete evacuation, sensation of anorectal blockage, and other associated symptoms of functional constipation. The significant improvement in most of the above symptoms was endured for a post-treatment observatory period of one week. All the study patients showed an excellent tolerability to the study drug. These findings suggest that “TLPL/AY/01/2008” is an effective, safe, and non-habit-forming herbal laxative formulation for the management of constipation. Comparative clinical studies with larger sample size would be able to confirm the above findings. PMID:22022157

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

ERIC Educational Resources Information Center

Guenzler, April M.

2016-01-01

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

An Evaluation of the Self-Efficacy Theory in Agricultural Education

ERIC Educational Resources Information Center

McKim, Aaron J.; Velez, Jonathan J.

2016-01-01

This research sought to evaluate the use of the self-efficacy theory in agricultural education. A total of 30 studies, published between 1997 and 2013 using self-efficacy as a theoretical foundation were compiled and analyzed. The findings of these studies were compared to expected outcomes identified by the self-efficacy theory, specifically the…

Effects of Self-Regulatory Strategy on Prospective Science Teachers' Chemistry Self Efficacy According to Class Level and Gender

ERIC Educational Resources Information Center

Seyhan, Hatice Güngör

2016-01-01

This study aimed at determining the self-regulatory strategies and the chemistry self-efficacies of a total of one hundred and eighty-nine prospective science teachers in a state university in Turkey while studying the chemistry lesson according to the class level and gender factors. An additional goal was to examine the relationship level between…

Efficacy of Atomoxetine for the Treatment of ADHD Symptoms in Patients with Pervasive Developmental Disorders: A Prospective, Open-Label Study

ERIC Educational Resources Information Center

Fernandez-Jaen, Alberto; Fernandez-Mayoralas, Daniel Martin; Calleja-Perez, Beatriz; Munoz-Jareno, Nuria; Campos Diaz, Maria del Rosario; Lopez-Arribas, Sonia

2013-01-01

Objective: Atomoxetine's tolerance and efficacy were studied in 24 patients with pervasive developmental disorder and symptoms of ADHD. Method: Prospective, open-label, 16-week study was performed, using the variables of the Clinical Global Impression Scale and the Conners' Scale, among others. Results: A significant difference was found between…

Characterization of mathematics instructional practises for prospective elementary teachers with varying levels of self-efficacy in classroom management and mathematics teaching

NASA Astrophysics Data System (ADS)

Lee, Carrie W.; Walkowiak, Temple A.; Nietfeld, John L.

2017-03-01

The purpose of this study was to investigate the relationship between prospective teachers' (PTs) instructional practises and their efficacy beliefs in classroom management and mathematics teaching. A sequential, explanatory mixed-methods design was employed. Results from efficacy surveys, implemented with 54 PTs were linked to a sample of teachers' instructional practises during the qualitative phase. In this phase, video-recorded lessons were analysed based on tasks, representations, discourse, and classroom management. Findings indicate that PTs with higher levels of mathematics teaching efficacy taught lessons characterised by tasks of higher cognitive demand, extended student explanations, student-to-student discourse, and explicit connections between representations. Classroom management efficacy seems to bear influence on the utilised grouping structures. These findings support explicit attention to PTs' mathematics teaching and classroom management efficacy throughout teacher preparation and a need for formative feedback to inform development of beliefs about teaching practises.

Falls efficacy, postural balance, and risk for falls in older adults with falls-related emergency department visits: prospective cohort study.

PubMed

Pua, Yong-Hao; Ong, Peck-Hoon; Clark, Ross Allan; Matcher, David B; Lim, Edwin Choon-Wyn

2017-12-21

Risk for falls in older adults has been associated with falls efficacy (self-perceived confidence in performing daily physical activities) and postural balance, but available evidence is limited and mixed. We examined the interaction between falls efficacy and postural balance and its association with future falls. We also investigated the association between falls efficacy and gait decline. Falls efficacy, measured by the Modified Falls Efficacy Scale (MFES), and standing postural balance, measured using computerized posturography on a balance board, were obtained from 247 older adults with a falls-related emergency department visit. Six-month prospective fall rate and habitual gait speed at 6 months post baseline assessment were also measured. In multivariable proportional odds analyses adjusted for potential confounders, falls efficacy modified the association between postural balance and fall risk (interaction P = 0.014): increasing falls efficacy accentuated the increased fall risk related to poor postural balance. Low baseline falls efficacy was strongly predictive of worse gait speed (0.11 m/s [0.06 to 0.16] slower gait speed per IQR decrease in MFES; P < 0.001). Older adults with high falls efficacy but poor postural balance were at greater risk for falls than those with low falls efficacy; however, low baseline falls efficacy was strongly associated with worse gait function at follow-up. Further research into these subgroups of older adults is warranted. ClinicalTrials.gov identifier: NCT01713543 .

Efficacy of early switch from intravenous to oral antimicrobials in patients with aspiration pneumonia: A prospective observational study.

PubMed

Uni, Masahiro; Nishimura, Naoki; Yamano, Yasuhiko; Ishikawa, Genta; Kitamura, Atsushi; Tomishima, Yutaka; Jinta, Torahiko; Takahashi, Osamu; Deshpande, Gautam; Chohnabayashi, Naohiko

2015-09-01

Previous reports have documented the efficacy of an early switch from intravenous to oral antimicrobials in community-acquired pneumonia, but not aspiration pneumonia. Therefore, we assessed the feasibility and efficacy of these newly developed criteria for community-acquired pneumonia in patients with aspiration pneumonia. This prospective observational study included consecutive patients admitted with aspiration pneumonia over a 10-month period at St. Luke's International Hospital; we excluded patients that required intensive care. The criteria for an early switch were stability of vital signs (temperature ≤ 38 °C; respiratory rate ≤ 24 breaths/min; pulse rate ≤ 100 beats/min for >24 h) and a successful swallow evaluation (repetitive saliva swallowing test score ≥ 2; modified water swallowing test score ≥ 4). Our primary endpoint was successful completion of antimicrobial treatment 30 days after the switch, without reversion to intravenous antimicrobials. Our anticipated success rate was set as 60-75%, based on a previous study. Of the 70 patients admitted with aspiration pneumonia, 32 (45.7%) were excluded, and 38 (54.3%) met the inclusion criteria. Of these 38 patients, 29 (76.3%) met the switch criteria. The median duration of hospital stay for the included patients was 16 (5-30) days and 30 (12-68) days, respectively (P=0.03). Among patients who met the switch criteria, 26 (89.7%) completed oral treatment successfully while 3 (10.3%) reverted to intravenous antimicrobials. Approximately 75% of patients met the switch criteria; of these, nearly 90% underwent safe conversion to oral therapy. These results demonstrate the efficacy and feasibility of our switch criteria. Copyright © 2015. Published by Elsevier B.V.

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.

Short time efficacy and safety of focused monopolar radiofrequency device for labial laxity improvement-noninvasive labia tissue tightening. A prospective cohort study.

PubMed

Fistonić, Ivan; Sorta Bilajac Turina, Iva; Fistonić, Nikola; Marton, Ingrid

2016-03-01

To evaluate safety and efficacy of focused monopolar radio frequency (RF) device for non-invasive labia tissue tightening and improvement of labial laxity. This prospective cohort study participants were 17 female subjects aged between 27 and 56 years with lax skin at the labia area. All subjects received four consecutive treatments at 7-day intervals with RF device (Exilis Protege IntimaR, BTL Industries Inc., Boston, MA). The primary efficacy outcome measure was defined as one or more point improvement on 1-4 scale for vulva appearance determined by three blinded evaluators. Digital photographs were taken at the baseline and 1 month after the last treatment. Sexual gratification was assessed with Female Sexual Functioning Index (FSFI) and patient discomfort by Visual Analogue Scale (VAS). An average 2.9 (of maximum 4) points improvement rate in vulvar appearance was observed (P < 0.01). Mean of the total FSFI score enhanced from initial 75-87% (P < 0.001). Resultant 4.7 (18%) points increase was achieved. Ninety four percent of subjects reported mild to none discomfort during the treatment. No adverse events during the study course were reported. The present study demonstrates the positive effect of focused monopolar RF device for non-invasive labia tissue tightening. The treatment is effective and safe with high patient satisfaction. © 2016 Wiley Periodicals, Inc.

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

Safety and efficacy of Gamma Knife radiosurgery in hypothalamic hamartomas with severe epilepsies: A prospective trial in 48 patients and review of the literature.

PubMed

Régis, Jean; Lagmari, Medhi; Carron, Romain; Hayashi, Motohiro; McGonigal, Aileen; Daquin, Géraldine; Villeneuve, Nathalie; Laguitton, Virginie; Bartolomei, Fabrice; Chauvel, Patrick

2017-06-01

Epilepsies associated with hypothalamic hamartomas (HHs) are frequently drug resistant with severe psychiatric and cognitive comorbidities. We performed a prospective trial to evaluate the safety and efficacy of Gamma Knife radiosurgery (GKS). Between October 1999 and October 2007, a total of 57 patients were investigated, included and treated by GKS in Timone University Hospital. Preoperative workup and 3-year postoperative evaluation consisted of seizure diary, neuropsychological, psychiatric, endocrinologic, visual field, and visual acuity examinations. Follow-up of >3 years was available for 48 patients. Topologic type was type I in 11 patients, type II in 15, type III in 17, type IV in one, type V in one, type VI in one, and mixed type in 2. The median marginal dose was 17 Gy (min 14 and max 25 Gy). The median target volume was 398 mm 3 (28-1,600 mm 3 ). Due to partial results, 28 patients (58.3%) required a second treatment. The median follow-up was 71 months (36-153 months). At last follow-up, the rate of Engel class I outcome was 39.6%, Engel class II was 29.2% (I+II 68.8%), and Engel class III was 20%. Global psychiatric comorbidity was considered cured in 28%, improved in 56%, stable in 8%, and continued to worsen in 8%. No permanent neurologic side effect was reported (in particular, no memory deficit). Nondisabling transient poikilothermia was observed in three patients (6.2%). A transient increase of seizure frequency was reported in 8 patients (16.6%) with a median duration of 30 days (9-90 days). Microsurgery was proposed because of insufficient efficacy of GKS in seven patients (14.5%) with a postoperative Engel class I-II in 28.6%. This prospective trial demonstrates very good long-term safety and efficacy of GKS for 2 patients. Beyond seizure reduction, the improvement of psychiatric and cognitive comorbidities along with better school performance and social functioning, being better socially integrated, having friends having a social life

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

Twelve-Month Efficacy and Safety Data for the "Stress Incontinence Control, Efficacy and Safety Study": A Phase III, Multicenter, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence Using the Vesair Intravesical Balloon.

PubMed

Winkler, Harvey; Jacoby, Karny; Kalota, Susan; Snyder, Jeffrey; Cline, Kevin; Robertson, Kaiser; Kahan, Randall; Green, Lonny; McCammon, Kurt; Rovner, Eric; Rardin, Charles

The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months. The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months. A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%). In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events

High Efficacy of Methotrexate in Patients with Recurrent Idiopathic Acute Anterior Uveitis: a Prospective Study.

PubMed

Bachta, Artur; Kisiel, Bartłomiej; Tłustochowicz, Mateusz; Raczkiewicz, Anna; Rękas, Marek; Tłustochowicz, Witold

2017-02-01

To evaluate prospectively the efficacy of methotrexate (MTX) in the treatment of recurrent idiopathic acute anterior uveitis (RIAAU). Nineteen out of 22 RIAAU patients completed the study (two patients withdrew their consent shortly after study initiation, one patient discontinued after 4 weeks because of the adverse effects). All patients were treated with MTX in a starting dose of 15 mg/week, increased to target dose of 25 mg/week after 4 weeks. In patients taking systemic corticosteroids (CS) the dose was gradually tapered (by 2.5 mg every week) until discontinuation. The mean follow-up period was 3.3 years (19-59 months). Sixteen patients (84 %) remained flare-free on MTX therapy. In the remaining three patients the mean interval between flares increased from 4.8 to 18.3 months. Systemic CS were tapered off in all patients. The number of acute anterior uveitis flares in the whole cohort decreased from 2.12 to 0.11/patient-year (p < 0.0001). All flares observed on MTX therapy occurred in HLA-B27-positive patients. MTX dosed at 25 mg/week is highly effective in the treatment of RIAAU.

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

Some findings on prospect and refuge theory: II.

PubMed

Stamps, Arthur E

2008-08-01

This article presents four new studies on the efficacy of predictions based on prospect and refuge theory and summarizes the results over eight studies. New data covered 49 participants and 36 environments. The eight studies included in the summary covered 144 participants and 80 widely diverse environments (Japanese Tatami rooms, Western rooms, porch, meadow, neighborhood commercial, shopping mall, vacation landscapes). Data were available for hypotheses about five factors: prospect, refuge, light, venue, and spatial transition. Efficacy was represented by correlations for the levels of the factors with responses of preference or comfort. Overall, venue was the most efficacious factor (r = .42, 95% CI = .14, .64). Efficacies for the other factors were very near zero. It is suggested that a considerable amount of additional formal inquiry be conducted before assuming the utility of prospect and refuge theory.

Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study.

PubMed

Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Rao, T Divakara; Gupta, Yogendra Kumar

2015-01-01

In the traditional system of medicine in India Ashwagandha powder and Sidh Makardhwaj have been used for the treatment of rheumatoid arthritis. However, safety and efficacy of this treatment have not been evaluated. Therefore, the present study was carried out to evaluate the efficacy and safety of Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj) in patients with rheumatoid arthritis. One hundred and twenty five patients with joint pain were screened at an Ayurvedic hospital in New Delhi, India. Eighty six patients satisfied inclusion criteria and were included in the study. Detailed medical history and physical examination were recorded. Patients took 5g of Ashwagandha powder twice a day for three weeks with lukewarm water or milk. Sidh Makardhwaj (100 mg) with honey was administered daily for the next four weeks. The follow up of patients was carried out every two weeks. The primary efficacy end point was based on American College of Rheumatology (ACR) 20 response. Secondary end points were ACR50, ACR70 responses, change from baseline in disease activity score (DAS) 28 score and ACR parameters. Safety assessments were hepatic function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin and ß2 microglobulin], renal function (urea and creatinine and NGAL) tests and urine mercury level. The study was completed by 90.7 per cent (78/86) patients. Patients with moderate and high disease activity were 57.7 per cent (45/78) and 42.3 per cent (33/78), respectively. All patients were tested positive for rheumatoid factor and increased ESR level. Ashwagandha and Sidh Makardhwaj treatment decreased RA factor. A significant change in post-treatment scores of tender joint counts, swollen joint counts, physician global assessment score, patient global assessment score, pain assessment score, patient self assessed disability index score and ESR level were observed as compared to baseline scores. ACR20 response was

Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study

PubMed Central

Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Rao, T. Divakara; Gupta, Yogendra Kumar

2015-01-01

Background & objectives: In the traditional system of medicine in India Ashwagandha powder and Sidh Makardhwaj have been used for the treatment of rheumatoid arthritis. However, safety and efficacy of this treatment have not been evaluated. Therefore, the present study was carried out to evaluate the efficacy and safety of Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj) in patients with rheumatoid arthritis. Methods: One hundred and twenty five patients with joint pain were screened at an Ayurvedic hospital in New Delhi, India. Eighty six patients satisfied inclusion criteria and were included in the study. Detailed medical history and physical examination were recorded. Patients took 5g of Ashwagandha powder twice a day for three weeks with lukewarm water or milk. Sidh Makardhwaj (100 mg) with honey was administered daily for the next four weeks. The follow up of patients was carried out every two weeks. The primary efficacy end point was based on American College of Rheumatology (ACR) 20 response. Secondary end points were ACR50, ACR70 responses, change from baseline in disease activity score (DAS) 28 score and ACR parameters. Safety assessments were hepatic function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin and ß2 microglobulin], renal function (urea and creatinine and NGAL) tests and urine mercury level. Results: The study was completed by 90.7 per cent (78/86) patients. Patients with moderate and high disease activity were 57.7 per cent (45/78) and 42.3 per cent (33/78), respectively. All patients were tested positive for rheumatoid factor and increased ESR level. Ashwagandha and Sidh Makardhwaj treatment decreased RA factor. A significant change in post-treatment scores of tender joint counts, swollen joint counts, physician global assessment score, patient global assessment score, pain assessment score, patient self assessed disability index score and ESR level were observed as

Proof Construction and Evaluation Practices of Prospective Mathematics Educators

ERIC Educational Resources Information Center

Imamoglu, Yesim; Togrol, Aysenur Yontar

2015-01-01

This study was conducted with 93 freshmen and 82 senior prospective mathematicians and mathematics teachers in order to investigate how they construct and evaluate proofs and whether there are any significant differences in their proof construction (with respect to department and grade) and proof evaluation (with respect to department)…

Efficacy methods to evaluate health communication and marketing campaigns.

PubMed

Evans, W Douglas; Uhrig, Jennifer; Davis, Kevin; McCormack, Lauren

2009-06-01

Communication and marketing are growing areas of health research, but relatively few rigorous efficacy studies have been conducted in these fields. In this article, we review recent health communication and marketing efficacy research, present two case studies that illustrate some of the considerations in making efficacy design choices, and advocate for greater emphasis on rigorous health communication and marketing efficacy research and the development of a research agenda. Much of the outcomes research in health communication and marketing, especially mass media, utilizes effectiveness designs conducted in real time, in the media markets or communities in which messages are delivered. Such evaluations may be impractical or impossible, however, imiting opportunities to advance the state of health communication and marketing research and the knowledge base on effective campaign strategies, messages, and channels. Efficacy and effectiveness studies use similar measures of behavior change. Efficacy studies, however, offer greater opportunities for experimental control, message exposure, and testing of health communication and marketing theory. By examining the literature and two in-depth case studies, we identify advantages and limitations to efficacy studies. We also identify considerations for when to adopt efficacy and effectiveness methods, alone or in combination. Finally, we outline a research agenda to investigate issues of internal and external validity, mode of message presentation, differences between marketing and message strategies, and behavioral outcomes.

Testing the prospective evaluation of a new healthcare system

PubMed Central

Planitz, Birgit; Sanderson, Penelope; Freeman, Clinton; Xiao, Tania; Botea, Adi; Orihuela, Cristina Beltran

2012-01-01

Research into health ICT adoption suggests that the failure to understand the clinical workplace has been a major contributing factor to the failure of many computer-based clinical systems. We suggest that clinicians and administrators need methods for envisioning future use when adopting new ICT. This paper presents and evaluates a six-stage “prospective evaluation” model that clinicians can use when assessing the impact of a new electronic patient information system on a Specialist Outpatients Department (SOPD). The prospective evaluation model encompasses normative, descriptive, formative and projective approaches. We show that this combination helped health informaticians to make reasonably accurate predictions for technology adoption at the SOPD. We suggest some refinements, however, to improve the scope and accuracy of predictions. PMID:23304347

Effects of Self-Efficacy on Healthy Eating Depends on Normative Support: a Prospective Study of Long-Haul Truck Drivers.

PubMed

Hamilton, Kyra; Hagger, Martin S

2018-04-01

Fruit and vegetable intake (FV) is insufficient in industrialized nations and there is excess of discretionary food choices (DC; foods high in fat, sugar, and salt). Long-haul truck drivers are considered a particularly at-risk group given the limited food choices and normatively reinforced eating habits at truck rest-stops. Self-efficacy and normative support are key determinants of eating behavior yet the processes underlying their effects on behavior are not well understood. We tested the direct and interactive effects of self-efficacy and normative support on healthy eating behaviors in long-haul truck drivers in a prospective correlational study. Long-haul truck drivers (N = 82) completed an initial survey containing self-report measures of behavioral intentions, perceived normative support, and self-efficacy for their FV and DC behaviors. Participants completed a follow-up survey 1 week later in which they self-reported their FV and DC behavior. A mediated moderation analysis identified an interactive effect of self-efficacy and normative support on behavior mediated by intention for FV and DC behavior. Specifically, we confirmed a compensation effect in which self-efficacy was more likely to have an effect on FV and DC behavior through intentions in participants with low normative support. Results indicate the importance of self-efficacy in predicting FV and DC intentions and behavior in the absence of a supportive normative environment. The compensatory effect of self-efficacy beliefs on behavior through intentions when normative support is low should be confirmed using experimental methods.

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…

Vitrectomy for floaters: prospective efficacy analyses and retrospective safety profile.

PubMed

Sebag, Jerry; Yee, Kenneth M P; Wa, Christianne A; Huang, Laura C; Sadun, Alfredo A

2014-06-01

Floaters impact vision but the mechanism is unknown. We hypothesize that floaters reduce contrast sensitivity function, which can be normalized by vitrectomy, and that minimally invasive vitrectomy will have lower incidences of retinal tears (reported at 30%) and cataracts (50-76%). Seventy-six eyes (34 phakic) with floaters were evaluated in 2 separate studies. Floater etiologies were primarily posterior vitreous detachment in 61 of 76 eyes (80%) and myopic vitreopathy in 24 of 76 eyes (32%). Minimally invasive 25G vitrectomy was performed without posterior vitreous detachment induction, leaving anterior vitreous, and using nonhollow probes for cannula extraction. Efficacy was studied prospectively (up to 9 months) in 16 floater cases with Freiburg Acuity Contrast Testing (Weber index [%W] reproducibility = 92.1%) and the National Eye Institute Visual Function Questionnaire. Safety was separately evaluated in 60 other cases followed up on an average of 17.5 months (range, 3-51 months). Floater eyes had 67% contrast sensitivity function attenuation (4.0 ± 2.3 %W; control subjects = 2.4 ± 0.9 %W, P < 0.013). After vitrectomy, contrast sensitivity function normalized in each case at 1 week (2.0 ± 1.4 %W, P < 0.01) and remained normal at 1 month (2.0 ± 1.0 %W, P < 0.003) and 3 months to 9 months (2.2 ± 1.5 %W, P < 0.018). Visual Function Questionnaire was 28.3% lower in floater patients (73.2 ± 15.6, N = 16) than in age-matched control subjects (93.9 ± 8.0, N = 12, P < 0.001), and postoperatively improved by 29.2% (P < 0.001). In the safety study of 60 floater cases treated with vitrectomy, none developed retinal breaks, infection, or glaucoma after a mean follow-up of 17.5 months. Only 8 of 34 cases (23.5%) required cataract surgery (none younger than 53 years) at an average of 15 months postvitrectomy. Floaters lower contrast sensitivity function, which normalizes after vitrectomy. Visual Function Questionnaire quantified improvement in satisfaction. Not

Supporting and improving community health services-a prospective evaluation of ECHO technology in community palliative care nursing teams.

PubMed

White, Clare; McIlfatrick, Sonja; Dunwoody, Lynn; Watson, Max

2015-12-01

Project ECHO (Extension for Community Healthcare Outcomes) uses teleconferencing technology to support and train healthcare providers (HCPs) remotely, and has improved care across the USA. A 6-month pilot was trialled in a community palliative care nursing setting to determine if ECHO would be effective in the UK in providing education and support to community hospice nurses (CHN). The pilot involved weekly 2 hour sessions of teaching and case-based discussions facilitated by hospice staff linking with nine teams of CHN using video conferencing technology. A mixed-methods prospective longitudinal cohort study was used to evaluate the pilot. Each CHN provided demographic data, and completed a written knowledge assessment and a self-efficacy tool before and after the pilot. Two focus groups were also performed after the pilot. 28 CHNs completed the evaluation. Mean knowledge score improved significantly from 71.3% to 82.7% (p=0.0005) as did overall self-efficacy scores following the ECHO pilot. Pre-ECHO (p=0.036) and Retro-Pretest ECHO (p=0.0005) self-efficacy were significantly lower than post-ECHO. There was no significant difference between Pretest and Retro-Pretest ECHO self-efficacy (p=0.063). 96% recorded gains in learning, and 90% felt that ECHO had improved the care they provided for patients. 83% would recommend ECHO to other HCPs. 70% stated the technology used in ECHO had given them access to education that would have been hard to access due to geography. This study supports the use of Project ECHO for CHNs in the UK by demonstrating how a 6-month pilot improved knowledge and self-efficacy. As a low-cost high-impact model, ECHO provides an affordable solution to addressing growing need. 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/

A Multi-centric, Double-blind, Placebo-controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of Carica papaya Leaf Extract, as Empirical Therapy for Thrombocytopenia associated with Dengue Fever.

PubMed

Kasture, Prabhu Nagnathappa; Nagabhushan, K H; Kumar, Arun

2016-06-01

Dengue is a rapidly expanding global health problem. Approximately 2.5 billion people live in dengue-risk regions with about 100 million new cases each year worldwide. The cumulative dengue diseases burden has attained an unprecedented proportion in recent times with sharp increase in the size of human population at risk. The management of dengue virus infection is essentially supportive and symptomatic and no specific treatment is available for increasing the fallen platelets, which have a significant role in causing the mortality of dengue patient.This study was conducted to evaluate the platelet increasing efficacy of Carica papaya leaf extract (CPLE) in patients with dengue fever (DF). The administration of Carica papaya leaf extract should significantly increase the platelet count in cases of thrombocytopenia associated with dengue, preventing the patient to go in DHF or DSS conditions. A Multi-centric, Double blind, Placebo controlled, Randomized, prospective study was conducted in 300 patients across 5 centres', to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue fever. The subjects were randomized into two groups, as control and intervention group. Both the groups were managed by the standard management guidelines for dengue except steroid administration. In addition to this, the intervention group received CPLE tablet three times daily for five days. All of them were followed daily with platelet monitoring. This study has been registered in the clinical trial registry-India (CTRI Registration number: CTRI/2015/05/005806). The results indicate that CPLE had significant increase(p< 0.01) in the platelet count over the therapy duration, in dengue fever patients, confirming CPLE accelerates the increase in platelet count compared to the control group. There were few adverse events related to GI disturbance like nausea and vomiting which were similar in both groups. Thus this study

Evaluating efficacy of an environmental policy to prevent biological invasions.

PubMed

Bailey, Sarah A; Deneau, Matthew G; Jean, Laurent; Wiley, Chris J; Leung, Brian; MacIsaac, Hugh J

2011-04-01

Enactment of any environmental policy should be followed by an evaluation of its efficacy to ensure optimal utilization of limited resources, yet measuring the success of these policies can be a challenging task owing to a dearth of data and confounding factors. We examine the efficacy of ballast water policies enacted to prevent biological invasions in the Laurentian Great Lakes. We utilize four criteria to assess the efficacy of this environmental regulation: (1) Is the prescribed management action demonstrably effective? (2) Is the management action effective under operational conditions? (3) Can compliance be achieved on a broad scale? (4) Are desired changes observed in the environment? The four lines of evidence resulting from this analysis indicate that the Great Lakes ballast water management program provides robust, but not complete, protection against ship-mediated biological invasions. Our analysis also indicates that corresponding inspection and enforcement efforts should be undertaken to ensure that environmental policies translate into increased environmental protection. Similar programs could be implemented immediately around the world to protect the biodiversity of the many freshwater ecosystems which receive ballast water discharges by international vessels. This general framework can be extended to evaluate efficacy of other environmental policies.

Retrospective and prospective evaluation of the Carbapenem inactivation method for the detection of carbapenemase-producing Enterobacteriaceae

PubMed Central

Gauthier, Lauraine; Dortet, Laurent; Naas, Thierry

2017-01-01

Background There is an urgent need for accurate and rapid diagnostic tests to identify carbapenemase producing enterobacteria (CPE). Here, we have evaluated the Carbapenem Inactivation Method (CIM) test to detect CPEs from cultured colonies. Methods A total of 256 enterobacterial isolates were used to evaluate the performance of the CIM in comparison to Carba NP test and molecular detection used a reference method. Ninety three well-characterized isolates (including 29 non-CPE and 63 CPEs of worldwide origin) with decreased susceptibility to at least one carbapenem were used to (i) evaluate the efficacy of CIM test and (ii) to compare it to the Carba NP test. We also tested different carbapenems to determine the best substrate for this test. Finally, the CIM test was then evaluated prospectively against 164 isolates referred to the French National Reference Center (NRC) for Antimicrobial Resistance from may 2016 to july 2016. Results Based on the results of this retrospective study, sensitivity and specificity of the CIM and the Carba NP test were 92.1% and 100%, respectively. We demonstrated that the meropenem was the best substrate to perform the CIM test since sensitivity and specificity were 81.1% and 100% using ertapenem disk, and 100% and 65,6% using imipenem disk, and respectively. Taking in account the results of retrospective and prospective studies, CIM and Carba NP tests have similar sensitivity, specificity, positive predictive value and negative predictive values being 96.3%, 98.9%, 99.0% and 98.4% for the CIM test versus 96.9%, 100%, 100% and 100% for the Carba NP test. Conclusions Our results confirm that the CIM test may be a useful tool for the reliable confirmation of carbapenemase-activity in enterobacterial isolates, especially in clinical microbiological laboratories with limited resources, no trained personnel, and no specialized equipment. PMID:28158310

Feasibility, efficacy, and predictive factors for the technical success of endoscopic nasogallbladder drainage: a prospective study.

PubMed

Yane, Kei; Maguchi, Hiroyuki; Katanuma, Akio; Takahashi, Kuniyuki; Osanai, Manabu; Kin, Toshifumi; Takaki, Ryo; Matsumoto, Kazuyuki; Gon, Katsushige; Matsumori, Tomoaki; Tomonari, Akiko; Nojima, Masanori

2015-03-01

Several studies have shown the useful-ness of endoscopic nasogallbladder drainage (ENGBD) in patients with acute cholecystitis. However, the procedure is difficult, and factors that affect technical success have not yet been clarified. We conducted a prospective study to eval-uate the technical feasibility, efficacy, and predictive factors for the technical success of ENGBD in patients with acute cholecystitis. All patients with moderate or severe acute cholecystitis who were enrolled underwent ENGBD between April 2009 and April 2011. Patients with surgically altered anatomy or pancreatobiliary malignancies were ex-cluded. The primary outcomes included technical success, clinical success, and complications. Factors that could affect the technical success were also examined. Of the 27 patients who underwent ENGBD during the study period, technical success was achieved in 21 (78%) and clinical improvement was achieved in 20 (95%). Early complications were encountered in four patients (15%). Gallbladder wall thickness (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.08 to 2.47) and age (OR, 1.16; 95% CI, 1.00 to 1.35) were effective predictors of technical failure. ENGBD was effective in resolving acute cholecystitis; however, this modality was technically challenging and had a limited suc-cess rate. Because of technical difficulties, ENGBD should be reserved for limited indications. (Gut Liver, 2015;9239-246).

Midterm prospective evaluation of TVT-Secur reveals high failure rate.

PubMed

Cornu, Jean-Nicolas; Sèbe, Philippe; Peyrat, Laurence; Ciofu, Calin; Cussenot, Olivier; Haab, Francois

2010-07-01

TVT-Secur has been described as a new minimally invasive sling for women's stress urinary incontinence (SUI) management, showing promising results in short-term studies. Our goal was to evaluate the outcome of this procedure after a midterm follow-up. A prospective evaluation involved 45 consecutive patients presenting SUI associated with urethral hypermobility. Fourteen patients preoperatively reported overactive bladder (OAB) symptoms, but none had objective detrusor overactivity. Eight patients had low maximal urethral closure pressure (MUCP). Four patients had pelvic organ prolapse (POP). Patients with POP were treated under general anesthesia by Prolift and TVT-Secur procedure. The 41 other patients received TVT-Secur under local anesthesia on an outpatient basis. All interventions were made by the same surgeon. Postoperative assessment included pad count, bladder diary, clinical examination with stress test, evaluation of satisfaction with the Patient Global Impression of Improvement (PGI-I) scale, and evaluation of side effects. Patients were classified as cured if they used no pads, had no leakage, and had a PGI-I score < or = 2; as improved in case of reduction of SUI symptoms >50% and PGI-I score < or = 3; and as failure otherwise. Mean postoperative follow-up was 30.2 +/- 9.8 mo (range: 11-40 mo). Short-term evaluation showed a 93.5% success rate, but, at last follow-up, only 18 (40%) patients were cured, while 8 (18%) were improved, and 19 (42%) failed. Twelve patients underwent implantation of TVT or transobturator tape during follow-up. Age, MUCP, or OAB were not associated with failure. Side effects were limited to five cases of de novo OAB and three cases of urinary tract infection. This work is limited by the absence of a comparison group. Our experience shows that despite its good short-term efficacy, TVT-Secur is associated with a high recurrence rate of SUI. Therefore, TVT-Secur does not seem appropriate for SUI first-line management in women

Prospective, pilot evaluation of the performance of nanofractional radiofrequency for improvement of skin texture via skin resurfacing.

PubMed

Bohnert, Krista; Dorizas, Andrew; Sadick, Neil

2018-02-01

The latest generation of radiofrequency, nanofractional radiofrequency, allows the heat energy to be delivered through the use of pins or needles as electrodes, facilitating increased efficacy and reduced pain, downtime, and side effects. The objective of this prospective pilot clinical study was to evaluate the efficacy of nanofractional radiofrequency in skin resurfacing. Seventeen subjects were enrolled in the study, and each received three nanofractional radiofrequency (160-pin tip) treatments in the facial area at 3-week intervals. Follow-up visits were scheduled at 1 and 2 months after the final treatment. Clinical photography, patient, and investigator assessments were conducted during the treatment visits and follow-up. All subjects completed the study. At the 1- and 2-month follow-up, there was a moderate to significant improvement (2.6 and 3.5, respectively, P = .01) according to the investigator global esthetic improvement scale rating. Most subjects reported that they were satisfied or very satisfied with the outcome and level of comfort. Nanofractional radiofrequency is a safe and effective strategy for improving texture, tone, and skin laxity with high patient satisfaction and tolerable safety profile. © 2017 Wiley Periodicals, Inc.

Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

PubMed

Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

2016-11-20

High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

[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.

Treatment efficacy of electromyography versus fiberscopy-guided botulinum toxin injection in adductor spasmodic dysphonia patients: a prospective comparative study.

PubMed

Kim, Jae Wook; Park, Jae Hong; Park, Ki Nam; Lee, Seung Won

2014-01-01

This study prospectively evaluates and compares the treatment efficacy of botulinum toxin injection under electromyography guidance (EMG group) and percutaneous botulinum toxin injection under flexible fiberscopic guidance (fiberscopy group). Thirty patients with adductor spasmodic dysphonia (ADSD), who had never received treatment, were randomly allocated into EMG- or fiberscopy-guided botulinum toxin injections between March 2008 and February 2010. We assessed acoustic and aerodynamic voice parameters, and the voice handicap index (VHI) before injection and at 1, 3, and 6 months after injection. The mean total dosage of botulinum toxin was similar for both groups: 1.7 ± 0.5 U for the EMG group and 1.8 ± 0.4 U for the fiberscopy group (P > 0.05). There were no significant differences in outcomes between the two groups in either the duration of effectiveness or complications such as breathy voice and aspiration. Botulinum toxin injection under fiberscopic guidance is a viable alternative to EMG-guided botulinum toxin injection for the treatment of adductor spasmodic dysphonia when EMG equipment is unavailable.

Treatment Efficacy of Electromyography versus Fiberscopy-Guided Botulinum Toxin Injection in Adductor Spasmodic Dysphonia Patients: A Prospective Comparative Study

PubMed Central

Kim, Jae Wook; Park, Jae Hong; Park, Ki Nam; Lee, Seung Won

2014-01-01

Introduction. This study prospectively evaluates and compares the treatment efficacy of botulinum toxin injection under electromyography guidance (EMG group) and percutaneous botulinum toxin injection under flexible fiberscopic guidance (fiberscopy group). Methods. Thirty patients with adductor spasmodic dysphonia (ADSD), who had never received treatment, were randomly allocated into EMG- or fiberscopy-guided botulinum toxin injections between March 2008 and February 2010. We assessed acoustic and aerodynamic voice parameters, and the voice handicap index (VHI) before injection and at 1, 3, and 6 months after injection. Results. The mean total dosage of botulinum toxin was similar for both groups: 1.7 ± 0.5 U for the EMG group and 1.8 ± 0.4 U for the fiberscopy group (P > 0.05). There were no significant differences in outcomes between the two groups in either the duration of effectiveness or complications such as breathy voice and aspiration. Conclusion. Botulinum toxin injection under fiberscopic guidance is a viable alternative to EMG-guided botulinum toxin injection for the treatment of adductor spasmodic dysphonia when EMG equipment is unavailable. PMID:25383369

Prospective phase II study evaluating the efficacy of swallow ability screening tests and pneumonia prevention using a team approach for elderly patients with gastric cancer.

PubMed

Miki, Yuichiro; Makuuchi, Rie; Honda, Shinsaku; Tokunaga, Masanori; Tanizawa, Yutaka; Bando, Etsuro; Kawamura, Taiichi; Yurikusa, Takashi; Tanuma, Akira; Terashima, Masanori

2018-03-01

Aging partly impairs swallowing function, which is considered a risk factor for postoperative pneumonia (PP). We evaluated the efficacy of a new team-based strategy to reduce the incidence of PP in elderly patients with gastric cancer. This single-center, prospective phase II study included elderly patients (≥75 years old) with gastric cancer undergoing gastric surgery. The primary endpoint was the incidence of Clavien-Dindo grade II or higher PP. Patients were initially screened using three swallowing function screening tests: a symptom questionnaire, the modified water swallow test (MSWT), and the repetitive saliva swallowing test (RSST). All patients were provided standard preoperative oral checks and care and simple neck muscle training. For patients who screened positive, a videofluorographic swallowing study was performed; if an abnormality was found, the patient was given intensive swallowing rehabilitation both pre- and postoperatively. Of 86 eligible patients enrolled, PP developed in 3 (3.5%). The 60% confidence interval of 1.8-6.3% had an upper limit below the prespecified threshold of 7.8%. Positive screening results were found for 19 patients (22.1%) on the symptom questionnaire, 3 (3.5%) on the MSWT, and 1 (1.2%) on the RSST. PP was not observed in any patients who screened positive. In conclusion, although the screening tests we adopted here were not sufficient to identify patients at high risk of aspiration pneumonia, perioperative interventions using a team approach might be effective in reducing the incidence of PP in elderly patients with gastric cancer.

Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis: A prospective, single-arm study.

PubMed

Okuda, Ryo; Matsushima, Hidekazu; Oba, Tomohiro; Kawabe, Rie; Matsubayashi, Minako; Amano, Masako; Nishizawa, Tomotaka; Honda, Koujiro

2016-05-01

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with few treatment options. The efficacy of N-acetylcysteine in patients with IPF remains controversial. The aim of this research was to investigate the efficacy of inhaled N-acetylcysteine. This study was designed as a single-center, single-arm, prospective clinical trial. Each patient who had IPF received 352.4mg of inhaled N-acetylcysteine twice daily. In total, 28 patients were enrolled. The mean values of the respiratory function parameters at the initiation of therapy were as follows: forced vital capacity (FVC), 2.27L and %FVC, 76.2%. The mean change in FVC during 26 weeks prior to the inhaled N-acetylcysteine therapy was -170mL, a significant decrease (p=0.019). The mean change in FVC during 26 weeks after the initiation of inhaled N-acetylcysteine therapy was -70mL (p=0.06). When the patients were classified into two groups according to the degree of decline in FVC (≥100mL vs. <100mL) during the 26-week period prior to the initiation of therapy, inhaled N-acetylcysteine showed a greater efficacy in attenuating FVC decline in the ≥100-mL group than in the <100-mL group. Inhaled N-acetylcysteine therapy was effective in patients with mild-to-moderate IPF and was more beneficial in patients who had greater declines in FVC before the initiation of therapy. (UMIN title: Efficacy and safety of inhaled N-acetylcysteine in idiopathic pulmonary fibrosis, UMIN000016706, 2015/03/04.). Copyright © 2015 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

The Efficacy of Neurofeedback in Patients with Major Depressive Disorder: An Open Labeled Prospective Study.

PubMed

Cheon, Eun-Jin; Koo, Bon-Hoon; Choi, Joong-Hyun

2016-03-01

The purpose of this study was to evaluate the effect of neurofeedback on depressive symptoms and electrophysiological disturbances in patients with major depressive disorder. We recruited participants suffering from depression to evaluate efficacy of left prefrontal beta with alpha/theta training. An 8-week, prospective, open-label study was undertaken. Twenty participants were recruited. The treatment protocol was twice or three times a week training of beta at F3 with alpha/theta at Pz for 8 weeks. When every visit, patients were received beta training for 30 min, and then alpha/theta training for 30 min. Baseline, 4 and 8 week scores of; the Hamilton rating scale for Depression (HAM-D), the Hamilton rating scale for Anxiety (HAM-A), the Beck Depression Inventory (BDI)-II, the Beck Anxiety Inventory (BAI), Clinical global impression-severity (CGI-S), and pre- and post-treatment resting state EEGs were compared. Interhemispheric alpha power asymmetry (A score) was computed for homologous sites F3-F4. Pre- and post-training clinical assessments revealed significant improvements in HAM-D, HAM-A, BDI, and CGI-S scores. Cumulative response rates by HAM-D were 35.0 and 75.0 % at 4 and 8 weeks, respectively, corresponding cumulative remission rates by HAM-D were 15.0 and 55.0 %, respectively. No significant differences were found between pre- and post-treatment A score. Neurofeedback treatment could improve depressive symptoms significantly. In addition, anxiety symptoms and clinical illness severity decreased significantly after neurofeedback treatment. Despite its several limitations, such as, small sample size and lack of a control group, this study suggested neurofeedback has significant effects in patients with major depressive disorder.

Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial

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

Ricke, Jens, E-mail: jens.ricke@med.ovgu.de; Jürgens, Julian H. W., E-mail: julian.juergens@med.ovgu.de; Deschamps, Frederic

2015-04-15

PurposeTo assess safety and efficacy of irreversible electroporation (IRE) of lung malignancies.Materials and MethodsPatients with primary and secondary lung malignancies and preserved lung function were included in this prospective single arm trial. Primary and secondary endpoints were safety and efficacy. Recruitment goal was 36 subjects in 2 centers. Patients underwent IRE under general anesthesia with probe placement performed in Fluoroscopy-CT. The IRE system employed was NanoKnife{sup ®} (Angiodynamics). System settings for the ablation procedure followed the manufacturer’s recommendations. The Mann–Whitney U test was used to evaluate the correlation of nine technical parameters with local tumor control. Median follow up wasmore » 12 months.ResultsThe expected efficacy was not met at interim analysis and the trial was stopped prematurely after inclusion of 23 patients (13/10 between both centers). The dominant tumor entity was colorectal (n = 13). The median tumor diameter was 16 mm (8–27 mm). Pneumothoraces were observed in 11 of 23 patients with chest tubes required in 8 (35 %). Frequently observed alveolar hemorrhage never led to significant hemoptysis. 14/23 showed progressive disease (61 %). Stable disease was found in 1 (4 %), partial remission in 1 (4 %) and complete remission in 7 (30 %) patients. The relative increase of the current during ablation was significantly higher in the group treated successfully as compared to the group presenting local recurrence (p < 0.05). Needle tract seeding was found in three cases (13 %).ConclusionsIRE is not effective for the treatment of lung malignancies. We hypothesize that the energy deposition with current IRE probes is highly sensitive to air exposure.« less

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)

The Efficacy of Stuttering Measurement Training: Evaluating Two Training Programs

ERIC Educational Resources Information Center

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

2015-01-01

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

Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study.

PubMed

Patel, Harsh S; Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

2016-07-01

Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions.

Prospective evaluation of oral gastrografin in postoperative small bowel obstruction.

PubMed

Kapoor, Sorabh; Jain, Gaurav; Sewkani, Ajit; Sharma, Sandesh; Patel, Kailash; Varshney, Subodh

2006-04-01

Orally administered gastrografin has been used for early resolution of postoperative small bowel obstruction (POSBO) and to reduce the need for surgery in various studies. However the studies have reported conflicting results as patients with complete obstruction and equivocal diagnosis of bowel strangulation were also included. We carried out a prospective study to evaluate the efficacy of gastrografin in patients with partial adhesive small bowel obstruction. Patients with suspected strangulation, complete obstruction, obstructed hernia, bowel malignancy, and radiation enteritis were excluded. Sixty-two patients with partial adhesive small bowel obstruction were given an initial trial of conservative management of 48 h. Thirty-eight patients improved within 48 h and the other 24 were given 100 ml of undiluted gastrografin through the nasogastric tube. In 22 patients the contrast reached the colon within 24 h. In the remaining two patients the contrast failed to reach the colon and these underwent surgery. The use of gastrografin avoided surgical intervention in 91.3% (22 of 24) patients who failed conservative management of POSBO. Gastrografin also decreased the overall requirement for surgical management of POSBO from the reported rate of 25 to 30% to 3.2% (2 of 62). Use of gastrografin in patients with partial POSBO helps in resolution of symptoms and avoids the need for surgical management in the majority of patients.

Healthcare professionals' attitudes, knowledge and self-efficacy levels regarding the use of self-hypnosis in childbirth: A prospective questionnaire survey.

PubMed

McAllister, Sophie; Coxon, Kirstie; Murrells, T; Sandall, J

2017-04-01

to examine healthcare professionals' attitudes, knowledge and levels of self-efficacy regarding the use of self-hypnosis in childbirth. a prospective survey. two large maternity units in London, England. healthcare professionals (n=129) involved in the care of childbearing women (anaesthetists, midwives and obstetricians). online questionnaire assessing healthcare professionals' experience, knowledge, attitudes and self-efficacy relating to self-hypnosis in childbirth. attitude, self-efficacy and knowledge. over half of the participants surveyed (56%) reported they had minimal or no knowledge of hypnosis. Higher levels of knowledge were associated with higher levels of self-efficacy (p<0.001) and also with more positive attitudes (p<.001). Midwives reported significantly higher levels of knowledge, more positive attitudes (7.25, 95% CI: 4.60-9.89) and higher levels of self-efficacy (3.48, 95% CI: 1.46-5.51) than doctors. Midwives also reported more exposure to/experience of hypnosis than doctors, and more exposure was significantly associated with higher levels of self-efficacy (midwives p<.001; doctors p=.001). Professionals who would plan to use self-hypnosis in their own or partners' births had significantly higher self-efficacy scores (p<.001). if healthcare professionals are to effectively support women using self-hypnosis in childbirth, they need to be confident in their ability to facilitate this method. Previous research has established that self-efficacy is a strong indicator of performance. Professionals with more knowledge of self-hypnosis are also more confident in supporting women using this technique in childbirth. Multi-disciplinary staff training which aims to increase knowledge, and which includes exposure to hypnosis in labour, may be beneficial in assisting staff to support women choosing to use self-hypnosis in labour. Copyright © 2017 Elsevier Ltd. All rights reserved.

Prospect evaluation of shallow I-35 reservoir of NE Malay Basin offshore, Terengganu, Malaysia

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

Janjua, Osama Akhtar, E-mail: janjua945@hotmail.com; Wahid, Ali, E-mail: ali.wahid@live.com; Salim, Ahmed Mohamed Ahmed, E-mail: mohamed.salim@petronas.com.my

2016-02-01

A potential accumulation of hydrocarbon that describes significant and conceivable drilling target is related to prospect. Possibility of success estimation, assuming discovery of hydrocarbons and the potential recoverable quantities range under a commercial development program are the basis of Prospect evaluation activities. The objective was to find the new shallow prospects in reservoir sandstone of I –Formation in Malay basin. The prospects in the study area are mostly consisting of faulted structures and stratigraphic channels. The methodology follows seismic interpretation and mapping, attribute analysis, evaluation of nearby well data i.e., based on well – log correlation. The petrophysical parameters analoguemore » to nearby wells was used as an input parameter for volumetric assessment. Based on analysis of presence and effectiveness, the prospect has a complete petroleum system. Two wells have been proposed to be drilled near the major fault and stratigraphic channel in I-35 reservoir that is O-1 and O-2 prospects respectively. The probability of geological success of prospect O-1 is at 35% while for O-2 is 24%. Finally, for hydrocarbon in place volumes were calculated which concluded the best estimate volume for oil in O-1 prospect is 4.99 MMSTB and O-2 prospect is 28.70 MMSTB while for gas is 29.27 BSCF and 25.59 BSCF respectively.« less

Efficacy of low dose gabapentin in acute herpes zoster for preventing postherpetic neuralgia: a prospective controlled study.

PubMed

Lee, Eo G; Lee, Hee J; Hyun, Dong J; Min, Kyunghoon; Kim, Dong H; Yoon, Moon S

2016-05-01

Postherpetic neuralgia (PHN) is a sequela of herpes zoster that adversely affects quality of life seriously. The risk factors for PHN are well known but the effective interventions that reduce the incidence of PHN are less studied. The objective of this study is to evaluate the efficacy of treatment with gabapentin in patients with acute herpes zoster for preventing PHN. We performed a prospective randomized controlled study of 120 participants diagnosed with acute herpes zoster, aged 50 and over and complaining moderate to severe pain. All patients were treated with valacyclovir and acetaminophen. Half of the participants were assigned to the gabapentin group and received gabapentin 300 mg three times a day additionally. The intensity of pain at every visit and the incidence of PHN in both groups were measured. Total 52 and 49 patients in the gabapentin group and the control group, respectively, had completed 12 weeks of follow-up period. Although the incidence of PHN was higher in the control group, the difference was not statistically significant (6.1% vs. 3.8%, p = 0.67). Our results indicate that the use of low-dose gabapentin in acute herpes zoster seems not effective in the prevention of PHN. © 2016 Wiley Periodicals, Inc.

Development and evaluation of the Marijuana Reduction Strategies Self-Efficacy Scale.

PubMed

Davis, Alan K; Osborn, Lawrence A; Leith, Jaclyn; Rosenberg, Harold; Ashrafioun, Lisham; Hawley, Anna; Bannon, Erin E; Jesse, Samantha; Kraus, Shane; Kryszak, Elizabeth; Cross, Nicole; Carhart, Victoria; Baik, Kyoung-deok

2014-06-01

To evaluate several psychometric properties of a questionnaire designed to assess college students' self-efficacy to employ 21 cognitive-behavioral strategies intended to reduce the amount and/or frequency with which they consume marijuana, we recruited 273 marijuana-using students to rate their confidence that they could employ each of the strategies. Examination of frequency counts for each item, principal components analysis, internal consistency reliability, and mean interitem correlation supported retaining all 21 items in a single scale. In support of criterion validity, marijuana use-reduction self-efficacy scores were significantly positively correlated with cross-situational confidence to abstain from marijuana, and significantly negatively correlated with quantity and frequency of marijuana use and marijuana-related problems. In addition, compared with respondents whose use of marijuana either increased or remained stable, self-efficacy was significantly higher among those who had decreased their use of marijuana over the past year. This relatively short and easily administered questionnaire could be used to identify college students who have low self-efficacy to employ specific marijuana reduction strategies and as an outcome measure to evaluate educational and skill-training interventions.

Exploring self-efficacy as a predictor of disease management.

PubMed

Clark, N M; Dodge, J A

1999-02-01

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

[Efficacy evaluation of lafutidine for mild reflux esophagitis in Japanese patients].

PubMed

Ohara, Shuichi; Haruma, Ken; Kinoshita, Yoshikazu; Kusano, Motoyasu

2010-04-01

To evaluate the efficacy of lafutidine (20mg) , famotidine (40mg) and placebo in patients with mild reflux esophagitis (Grades A and B according to the Los Angeles classification) , a double-blind, multicenter, randomized clinical trial was performed for the first time in Japanese patients. In addition to each physician's evaluation, efficacy was evaluated by judging panels using images submitted by each physician. The healing rate after 8 weeks for lafutidine, famotidine and placebo were 67.7%, 56.6% and 41.2%, respectively. Lafutidine was significantly more effective than placebo (p=0.002, according to the judging panels) . Based on the evaluation of endoscopic images by the judging panels, 91 (27.1%) of 336 images submitted by each physician were judged to not be mucosal breaks. Judging panels are considered one of the ways to resolve the problem of the need to unify the criteria.

A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg.

PubMed

Festin, Mario P R; Bahamondes, Luis; Nguyen, Thi My Huong; Habib, Ndema; Thamkhantho, Manopchai; Singh, Kuldip; Gosavi, Arundhati; Bartfai, Gyorgy; Bito, Tamas; Bahamondes, M Valeria; Kapp, Nathalie

2016-03-01

Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. A total of 330 healthy fertile women aged 18-45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability questions were administered. There were 321 women included in the evaluable population (which includes all eligible women

Checklists for the Evaluation of Educational Software: Critical Review and Prospects.

ERIC Educational Resources Information Center

Tergan, Sigmar-Olaf

1998-01-01

Reviews strengths and weaknesses of check lists for the evaluation of computer software and outlines consequences for their practical application. Suggests an approach based on an instructional design model and a comprehensive framework to cope with problems of validity and predictive power of software evaluation. Discusses prospects of the…

Measuring change in quality of life: bias in prospective and retrospective evaluation.

PubMed

Blome, Christine; Augustin, Matthias

2015-01-01

Treatment effects on health-related quality of life (QOL) often differ depending on whether they are measured prospectively (before and after treatment) or retrospectively (after treatment only). These two approaches can be subject to different sorts of bias: Prospective evaluations may be biased by scale recalibration (a changed understanding of the response scale), and retrospective evaluations may be biased by recall bias (a wrong assessment of former QOL). On the basis of an analysis of the literature, we present an overview on possible biases in prospective and retrospective measurement of QOL and how these biases are named and defined in the literature. The definitions of different biases are inconsistent. Many authors do not clearly distinguish measurement bias from true change. Furthermore, some consider only scale recalibration or only recall bias. Much of the current discussion on bias in prospective and retrospective QOL measurement suffers from unclear definitions, especially of "response shift" and "recall bias," or from neglecting one of the possible biases. We suggest more elaborate definitions for different types of bias and recommend taking both kinds of bias into consideration when measuring change in QOL. The relevance of the different biases depends on the type of study, and so either prospective or retrospective assessment may be more appropriate. Copyright © 2015. Published by Elsevier Inc.

[Prospective, monocentric, uncontrolled study of efficacy, tolerance and adherence of cyclosporin 0.1 % for severe dry eye syndrome].

PubMed

Boujnah, Y; Mouchel, R; El-Chehab, H; Dot, C; Burillon, C; Kocaba, V

2018-02-01

To evaluate the efficacy, tolerability and treatment adherence of Ikervis ® (Santen, SAS) (ciclosporine 0.1 %) for first line therapy or following treatment with Restasis ® (Allergan, Inc.) (ciclosporine 0.05 %) for severe dry eye syndrome. A prospective, monocentric, uncontrolled study was conducted between January 2012 and March 2015 on 110 eyes of 55 patients with severe dry eye on first line therapy or previously treated with Restasis ® who required the introduction of Ikervis ® . Patients' quality of life was assessed before and after treatment was started using a standardized questionnaire (Ocular Surface Disease Index © [OSDI]), clinical efficacy was quantified at the slit lamp, by measurement of the Break Up time Test (BUT) and the Oxford classification. Tolerability and adherence to treatment were measured using a simple questionnaire. A total of 72 eyes of 37 patients were included. Etiologies of dry eye syndrome were dominated by Sjögren syndrome (32 %) and severe ocular surface conditions (48 %). The mean age was 57.7 years (±17.45) and mean follow-up was 458 days (±292). The mean BUT increased by 2.043seconds [1.522-2.563] (P<0.0001). Corneal/conjunctival involvement evaluated by the Oxford classification was also improved with a difference in level of 1.68 [1.290-2.071] (P<0.0001). Ocular Surface Disease Index © (OSDI) decreased by 21.7 [16.372-27.024] (P<0.0001). Treatment tolerability was moderate, with more than 50 % of patients experiencing pain on instillation. Overall satisfaction with treatment was good, with more than 60 % of patients feeling better after initiation of treatment. Ikervis ® is an effective treatment of severe dry eye. Its indications tend to evolve towards less severe dry eye. However, the tolerability profile remains poor, and an improvement in this would be desirable. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Efficacy of an activated charcoal-simethicone combination in dyspeptic syndrome: results of a randomized prospective study in general practice.

PubMed

Lecuyer, M; Cousin, T; Monnot, M-N; Coffin, B

2009-01-01

The aim of this prospective, multicenter, randomized, placebo-controlled trial was to evaluate the efficacy of a commercial combination of simethicone and activated charcoal (Carbosylane) on dyspeptic symptoms in patients consulting a general practitioner. A total of 132 patients were studied. Treatment duration was 3 months, followed by a 2 months follow-up period. At the end of the treatment period, the percentage of patients with a reduction of at least two points on the symptom intensity scale was significantly higher with Carbosylane than with a placebo (P=0.043). Compared with placebo, the intensity of three symptoms (abdominal fullness, bloating and the sensation of slow digestion) was significantly decreased after 90 days of Carbosylane (P<0.05). At the end of the post-treatment follow-up, the percentages of patients with moderate or severe global complaints were 6.78% and 21.43% in the Carbosylane and placebo groups, respectively (P<0.03). Among patients consulting a general practitioner for dyspeptic syndrome, 3 months of treatment with Carbosylane resulted in significant symptomatic improvement. The improvement was still evident 2 months after the end of treatment.

Indigenous traditional knowledge and substance abuse treatment outcomes: the problem of efficacy evaluation.

PubMed

Gone, Joseph P

2012-09-01

In the field of substance abuse treatment, American Indian and Alaska Native (AI/AN) communities have routinely incorporated ceremonial practices as one important component in the promotion of recovery and healing. The beneficial effects of such practices are frequently described as plainly apparent by community-based advocates, providers, and professionals alike. In the present era of evidence-based substance abuse intervention, however, indigenous integration of such practices raises questions pertaining to the systematic evaluation of treatment efficacy. The focus of this article is outcome evaluation. Although intervention outcome researchers recognize the randomized controlled trial as the "gold standard" against which claims of treatment efficacy are measured, AI/AN efficacy assertions grounded in indigenous traditional knowledge (ITK) reflect different concerns that have emerged in non-Western historical contexts. The interface between scientific and indigenous "ways of knowing" is explored here relative to efficacy claims about substance abuse treatment. Distinguishing features of both scientific knowing and ITK are summarized and compared. ITK has been described as personal and experiential, reflecting the primacy of autonomous individual knowing. In contrast, intervention scientists are skeptical of personal inference as a basis for efficacy evaluation. The evident divergence between these epistemic paradigms can result in potentially contradictory claims. Proper appraisal of the status and relevance of ITK for determining treatment efficacy requires further exploration of these marginalized approaches to knowledge. Intervention scientists who work in AI/AN communities should remain open to the legitimacy and role of ITKs in investigations of substance abuse treatment.

Efficacy of Long-Term Oral Vitamin B12 Supplementation after Total Gastrectomy: Results from a Prospective Study

PubMed Central

Moleiro, Joana; Mão de Ferro, Susana; Ferreira, Sara; Serrano, Miguel; Silveira, Margarida; Dias Pereira, António

2018-01-01

Background/Objectives Vitamin B12 (VB12) deficiency is a common complication after total gastrectomy which may be associated with megaloblastic anemia and potentially irreversible neurologic symptoms. Intramuscular supplementation of VB12 has been considered the standard treatment, although it is associated with high costs and patient discomfort. Patients/Methods We performed a prospective uncontrolled study (ACTRN12614000107628) in order to evaluate the clinical and laboratory efficacy of long-term oral VB12 supplementation in patients submitted to total gastrectomy. All patients received daily oral VB12 (1 mg/day) and were evaluated every 3 months (clinical and laboratory evaluation: hemoglobin, VB12, total iron, ferritin, and folate). Results A total of 26 patients were included with a mean age of 64 years (29–79). Patients were included with a mean period of 65 months (3–309) after total gastrectomy. At inclusion time, 17/26 patients were under intramuscular VB12, and 9 had not started supplementation yet. There were normal serum VB12 levels in 25/26 patients (mean VB12 serum levels: 657 pg/mL). The mean follow-up period was 20 (8.5–28) months. During follow-up, all patients had normal VB12 levels and there was no need for intramuscular supplementation. The patient with low VB12 levels had an increase to adequate levels, which remained stable. There were no differences with statistical significance among VB12 levels at 6 (867 pg/mL), 12 (1,008 pg/mL), 18 (1,018 pg/mL), and 24 (1,061 pg/mL) months. Iron and folate supplementation was necessary in 21 and 7 patients, respectively. Conclusions Oral VB12 supplementation is effective and safe in patients who underwent total gastrectomy and should be considered the preferential form of supplementation. PMID:29761147

Efficacy of Blended Preservice Training for Resource Parents

PubMed Central

White, Lee; Delaney, Richard; Pacifici, Caesar; Nelson, Carol; Whitkin, Josh; Lovejoy, Maureen; Smalley, Betsy Keefer

2017-01-01

To evaluate a new way of meeting the growing demand for training prospective resource parents, our study compared the efficacy of a blended online and in-person approach with a traditional classroom-only approach. Findings based on a sample of 111 resource parent prospects showed significantly greater gains in knowledge from pre- to posttest for the blended approach over the classroom-only approach. The blended approach also produced dramatically lower dropout rates during preservice training. Both groups made significant gains in parenting awareness from pre to post, but those gains were greater for the classroom-only approach. Post hoc analyses examined this finding more closely. Satisfaction with training was comparably high for both groups. Gains in knowledge and awareness were sustained at a 3-month follow-up assessment. PMID:28626240

Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

PubMed

Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

2016-02-01

Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

Cardiac catheterization laboratory inpatient forecast tool: a prospective evaluation

PubMed Central

Flanagan, Eleni; Siddiqui, Sauleh; Appelbaum, Jeff; Kasper, Edward K; Levin, Scott

2016-01-01

Objective To develop and prospectively evaluate a web-based tool that forecasts the daily bed need for admissions from the cardiac catheterization laboratory using routinely available clinical data within electronic medical records (EMRs). Methods The forecast model was derived using a 13-month retrospective cohort of 6384 catheterization patients. Predictor variables such as demographics, scheduled procedures, and clinical indicators mined from free-text notes were input to a multivariable logistic regression model that predicted the probability of inpatient admission. The model was embedded into a web-based application connected to the local EMR system and used to support bed management decisions. After implementation, the tool was prospectively evaluated for accuracy on a 13-month test cohort of 7029 catheterization patients. Results The forecast model predicted admission with an area under the receiver operating characteristic curve of 0.722. Daily aggregate forecasts were accurate to within one bed for 70.3% of days and within three beds for 97.5% of days during the prospective evaluation period. The web-based application housing the forecast model was used by cardiology providers in practice to estimate daily admissions from the catheterization laboratory. Discussion The forecast model identified older age, male gender, invasive procedures, coronary artery bypass grafts, and a history of congestive heart failure as qualities indicating a patient was at increased risk for admission. Diagnostic procedures and less acute clinical indicators decreased patients’ risk of admission. Despite the site-specific limitations of the model, these findings were supported by the literature. Conclusion Data-driven predictive analytics may be used to accurately forecast daily demand for inpatient beds for cardiac catheterization patients. Connecting these analytics to EMR data sources has the potential to provide advanced operational decision support. PMID:26342217

A Prospective Evaluation of Helical Tomotherapy

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

Bauman, Glenn; Yartsev, Slav; Rodrigues, George

2007-06-01

Purpose: To report results from two clinical trials evaluating helical tomotherapy (HT). Methods and Materials: Patients were enrolled in one of two prospective trials of HT (one for palliative and one for radical treatment). Both an HT plan and a companion three-dimensional conformal radiotherapy (3D-CRT) plan were generated. Pretreatment megavoltage computed tomography was used for daily image guidance. Results: From September 2004 to January 2006, a total of 61 sites in 60 patients were treated. In all but one case, a clinically acceptable tomotherapy plan for treatment was generated. Helical tomotherapy plans were subjectively equivalent or superior to 3D-CRT inmore » 95% of plans. Helical tomotherapy was deemed equivalent or superior in two thirds of dose-volume point comparisons. In cases of inferiority, differences were either clinically insignificant and/or reflected deliberate tradeoffs to optimize the HT plan. Overall imaging and treatment time (median) was 27 min (range, 16-91 min). According to a patient questionnaire, 78% of patients were satisfied to very satisfied with the treatment process. Conclusions: Helical tomotherapy demonstrated clear advantages over conventional 3D-CRT in this diverse patient group. The prospective trials were helpful in deploying this technology in a busy clinical setting.« less

Prospective evaluation of 1-day polyethylene glycol-3350 bowel preparation regimen in children.

PubMed

Abbas, Mazen I; Nylund, Cade M; Bruch, Carol J; Nazareno, Luzviminda G; Rogers, Philip L

2013-02-01

The aim of the present study was to evaluate efficacy, safety, and tolerability of a pediatric colonoscopy bowel preparation regimen composed of polyethylene glycol-3350 (PEG-3350) and a sports drink completed in a few hours. A prospective, open-label trial of a colonoscopy bowel preparation in children ages 8 to 18 years that included 238 g of PEG-3350 mixed with 1.9 L of Gatorade completed in a few hours. Efficacy was determined using the Boston Bowel Preparation Scale. Basic metabolic profiles and questionnaires were obtained that assessed for safety, adverse effects, tolerability, and patient acceptability. Forty-six patients completed the study. Patients were predominately boys (56.5%) with a mean age of 14.50 years (SD ± 2.9 years). Forty-three (93.5%) were able to complete the regimen. All of the colonoscopies were completed to the cecum and 84% had terminal ileum visualization. Seventy-seven percent were found to be effective preparations. Nausea/vomiting were the most common reported adverse effect (60%) followed by abdominal pain/cramping (44%) and fatigue/weakness (40%). Overall, the regimen was acceptable with 1 exception being the large volume to drink. There were no clinically significant changes in basic metabolic profiles, although there was a statistically significant decrease in the mean potassium (0.16 mEq/L; P = 0.016), blood urea nitrogen (2.68 mg/dL; P < 0.0001), and carbon dioxide (1.89 mmol/L; P < 0.0001). This study demonstrated that PEG-3350 + Gatorade administered in a few hours is an effective, safe, and moderately tolerable bowel preparation regimen for colonoscopy in children.

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 efficacy in a liver pretransplantation orientation group.

PubMed

Guimaro, M Simon; Lacerda, S Silva; Bacoccina, T D; Karam, C Hegedus; de Sá, J Roberto; Ferraz-Neto, B H; Andreoli, P Bruno de Araújo

2007-10-01

The medical context recognizes the efficiency of working with groups of patients. Group interventions can intensify the understanding, ability, and notion of recognizing the patient's own condition, increasing the responsibility for him- or herself. This survey sought to evaluate the efficacy of an interdisciplinary orientation group for hepatic transplantation preoperatively. The opinions of all patients on a waiting list for liver transplantation and their accompanying persons were evaluated from August to December 2005 through a questionnaire with 17 relevant items concerning the transplantation process. The group efficacy was evaluated according to the percentage of correct answers from the subjects before and after attending the group. The results showed a 59% increase in correct answers for the evaluated items after group attendance. The items which showed significant improvement were: what should I do after being called for transplantation; average time of admission to hospital and ICU; use of immunosuppressive drugs; clinical conditions for transplantation; frequency of appointments with the surgeon within the first month; physical activities; diet; blood transfusion; and forgetting medication. A ceiling effect was observed upon reevaluation of the previous conditions for transplantation item. The percentage of health improvement after attending the group demonstrated an impact of the interdisciplinary orientation intervention on the instruction of patients and their accompanying persons, thus representing an important step in their training process.

The Efficacy of Math Coaching: An Evaluative Case Study

ERIC Educational Resources Information Center

Dobbins, C. Neelie

2010-01-01

There is a lack of implementation of instructional strategies to assist middle school teachers in improving mathematics education for their students. Coaching is one solution to this problem, but its impact on student achievement is unclear. This case study evaluated the relationship between coaching and teacher efficacy and the impact of these…

Evaluation of the efficacy and safety of Tribulus terrestris in male sexual dysfunction-A prospective, randomized, double-blind, placebo-controlled clinical trial.

PubMed

Kamenov, Zdravko; Fileva, Svetlana; Kalinov, Krassimir; Jannini, Emmanuele A

2017-05-01

The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment. Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan ® , Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants' sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation. 86 patients in each group completed the study. The IIEF

Confirmatory Factor Analysis of the Teacher Efficacy Scale for Prospective Teachers

ERIC Educational Resources Information Center

Denzine, Gypsy M.; Cooney, John B.; McKenzie, Rita

2005-01-01

Background: Research on teacher self-efficacy has revealed substantive problems concerning the validity of instruments used to measure teacher self-efficacy beliefs. Although claims about the influence of teachers' self-efficacy beliefs on student achievement, success with curriculum innovation, and so on, may be true statements, one cannot make…

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 and tolerability of six-week extended dosing interval with tocilizumab therapy in a prospective cohort as remission maintenance in patients with rheumatoid arthritis.

PubMed

Kikuchi, Jun; Kondo, Tsuneo; Shibata, Akiko; Sakai, Ryota; Okada, Yusuke; Chino, Kentaro; Okuyama, Ayumi; Kurasawa, Takahiko; Takei, Hirofumi; Amano, Koichi

2018-05-01

To prospectively evaluate the efficacy and tolerability of a six-week extended dosing interval with tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in sustained remission. Patients who received over six doses of intravenous TCZ in clinical remission (disease activity score [DAS] 28 - erythrocyte sedimentation rate [ESR] ≤ 2.6) maintained over 3 months between December 2013 and December 2015 were included. Flare was defined as DAS28-ESR >3.2 at two consecutive visits. Twenty-five patients were enrolled; 87.5% achieved clinical remission at week 54 after six-week extension and 95.5% achieved a van der Heijde modified total Sharp score (ΔmTSS) ≤0.5. The Health Assessment Questionnaire Disability Index (HAQ-DI) did not increase during 54 weeks. HAQ-DI at baseline and ΔDAS28-ESR at week six positively correlated with increase in DAS28-ESR at week 54. ΔSwollen joint count at week six positively correlated with ΔmTSS at week 54. A total of 12 adverse events occurring in 10 patients did not lead to cessation of TCZ except for one case of recurrent lymphoproliferative disorder at week five. A six-week extended dosing interval of TCZ for patients with RA in sustained remission is proposed as an acceptable treatment option for maintaining efficacy and tolerability.

Teacher Efficacy: A Study of Construct Dimensions.

ERIC Educational Resources Information Center

Guskey, Thomas R.; Passaro, Perry

The structure of a concept generally labeled "teacher efficacy" is examined. A sample of 342 prospective and experienced teachers was administered an efficacy questionnaire adapted from the research of S. Gibson and M. H. Dembo (1984). Factor analytic procedures with varimax rotation were used to generate a 2-factor solution that accounted for 32…

Evaluation of the efficacy and safety of bi-daily combination therapy with pyridoxine and doxylamine for nausea and vomiting of pregnancy.

PubMed

Ashkenazi-Hoffnung, Liat; Merlob, Paul; Stahl, Bracha; Klinger, Gil

2013-01-01

Diclectin (pyridoxine 10 mg and doxylamine 10 mg) has traditionally been used to treat nausea and vomiting of pregnancy (NVP); however, this drug is unavailable in many countries. To evaluate the efficacy and safety of a simple bi-daily treatment regimen with the combination of pyridoxine (50 mg twice daily) and doxylamine (25-50 mg) as an alternative treatment for NVP. A prospective case-controlled observational study of mother-infant pairs was conducted between February 2008 and December 2010. All women who contacted the Beilinson Teratology Information Service (BELTIS) regarding treatment of NVP were eligible for inclusion. Using data on NVP severity, treatment efficacy and outcomes, we compared the two groups of women: those treated with the combination of pyridoxine and doxylamine (treatment group, n=29) and those treated with metoclopramide (control group, n=29). Moderate to severe symptoms were present in 97% of the treatment group women vs. 69% of control group women (P < 0.01). Despite increased symptom severity in the treatment group, the combination regimen was efficacious: 20/29 (69%) vs. 18/25 (72%) in the treatment vs. control women respectively (P = 0.65). There were no congenital anomalies in the treatment group. Follow-up was normal for all infants. Bi-daily combination therapy with pyridoxine and doxylamine for NVP is safe, has comparable efficacy to metoclopramide, and is a treatment alternative in countries where Diclectin is not available. Despite symptoms warranting counseling by a teratology information service, more than a third of women do not take the suggested treatment.

Efficacy of a separate informed consent for anesthesia services: A prospective study from the Caribbean.

PubMed

Rampersad, Kavi; Chen, Deryk; Hariharan, Seetharaman

2016-01-01

This study aimed to determine whether a separate written consent form improved the efficacy of the informed consent process for anesthesia in adult patients undergoing elective surgery at a tertiary care teaching hospital. We randomized patients into two groups prospectively. The first group (Group A) signed the hospital's standard Consent for Operation form only while the second group (Group B) signed a separate Consent for Anesthesia form additionally. Patients were interviewed postoperatively with an eight-item questionnaire with responses in a 5-point Likert scale. A composite adequacy of consent index was generated from the responses and analyzed. Two hundred patients (100 in each group) were studied. All patients indicated that the anesthesiologist(s) had their permission to proceed with their anesthesia care. The mean adequacy of consent index score in Group B was higher than that of Group A (30.6 ± 4.6 [standard deviation (SD)] vs. 27.9 ± 5.2 [SD]) (P < 0.001). The separate written consent had a positive impact on the patients' understanding of the nature and purpose of the intended anesthesia procedures (P = 0.04), satisfaction with the adequacy of information provided about common side effects (P < 0.001) and rare but serious complications (P = 0.008). A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications.

Evaluation of the Program Effectiveness of Research Competence Development in Prospective Elementary School Teachers

ERIC Educational Resources Information Center

Khan, Natalya N.; Kolumbayeva, Sholpan Zh.; Karsybayeva, Raissa K.; Nabuova, Roza A.; Kurmanbekova, Manshuk B.; Syzdykbayeva, Aigul Dzh.

2016-01-01

To develop research competence in prospective teachers, a system of methods for diagnostics and formation of this competence in prospective elementary school teachers in the training process is designed. To diagnose the research competence, a series of techniques were used that allow subtle evaluation of each competence research component:…

Pethidine efficacy in achieving the ultrasound-guided oblique subcostal transversus abdominis plane block in laparoscopic cholecystectomy: A prospective study.

PubMed

Breazu, Caius Mihai; Ciobanu, Lidia; Bartos, Adrian; Bodea, Raluca; Mircea, Petru Adrian; Ionescu, Daniela

2017-02-21

Pethidine is a synthetic opioid with local anesthetic properties. Our goal was to evaluate the analgesic efficacy of pethidine for achieving the ultrasound-guided oblique subcostal transversus abdominis plane (OSTAP) block in laparoscopic cholecystectomy. This prospective, double-blind study included 79 patients of physical status I and II according to American Society of Anesthesiologists, scheduled for elective laparoscopic cholecystectomy. The patients were randomly allocated into three groups, depending on the drug used to achieve preoperative bilateral OSTAP block: 1) OSTAP-Placebo (treated with normal saline); 2) OSTAP-Bupivacaine (treated with 0.25% bupivacaine); and 3) OSTAP-Pethidine (treated with 1% pethidine). The efficacy of pethidine in achieving the OSTAP block was analyzed using visual analog scale (VAS), intraoperative opioid dose, opioid consumption in post anesthesia care unit, and opioid consumption in the first 24 postoperative hours. The pain scores assessed by VAS at 0, 2, 4, 6, 12, and 24 hours were significantly lower in OSTAP-Pethidine than in OSTAP-Placebo group (p < 0.001). The mean intraoperative opioid consumption was significantly lower in OSTAP-Pethidine compared to OSTAP-Placebo group (150 versus 400 mg, p < 0.001), as well as the mean opioid consumption in the first 24 hours (20.4 versus 78 mg, p < 0.001). Comparing VAS assessment between OSTAP-Bupivacaine and OSTAP-Pethidine groups, statistically significant differences were observed only for the immediate postoperative pain assessment (0 hours), where lower values were observed in OSTAP-Pethidine group (p = 0.004). There were no statistically significant differences in the incidence of postoperative nausea and vomiting (p = 0.131) between the groups. The use of 1% pethidine can be an alternative to 0.25% bupivacaine in achieving OSTAP block for laparoscopic cholecystectomy.

The cubic ternary complex receptor-occupancy model. III. resurrecting efficacy.

PubMed

Weiss, J M; Morgan, P H; Lutz, M W; Kenakin, T P

1996-08-21

Early work in pharmacology characterized the interaction of receptors and ligands in terms of two parameters, affinity and efficacy, an approach we term the bipartite view. A precise formulation of efficacy only exists for very simple pharmacological models. Here we extend the notion of efficacy to models that incorporate receptor activation and G-protein coupling. Using the cubic ternary complex model, we show that efficacy is not purely a property of the ligand-receptor interaction; it also depends upon the distributional details of the receptor species in the native receptor ensemble. This suggests a distinction between what we call potential efficacy (a vector) and realized efficacy (a scalar). To each receptor species in the native receptor ensemble we assign a part-worth utility; taken together these utilities comprise the potential efficacy vector. Realized efficacy is the expectation of these part-worth utilities with respect to the frequency distribution of receptor species in the native receptor ensemble. In the parlance of statistical decision theory, the binding of a ligand to a receptor ensemble is a random prospect and realized efficacy is the utility of this prospect. We explore the implications that our definition of efficacy has for understanding agonism and in assessing the legitimacy of the bipartite view in pharmacology.

Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study.

PubMed

Vanlangenhove, Peter; De Keukeleire, Katrien; Everaert, Karel; Van Maele, Georges; Defreyne, Luc

2012-06-01

This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. A total of 112 insufficient spermatic veins (left-sided, n=84; right-sided, n=28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n=54; Histoacryl, Braun, Germany) or NBCA-MS (n=58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n=54/54, 100% vs. NBCA-MS, n=54/57, 94.7%; P=0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n=45/54, 83.3% vs. NBCA-MS, n=41/58, 70.7%; P=0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n=25/54, 46.3% vs. NBCA-MS, n=29/58, 50%; P=0.71). No glue-related complications were noted. NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg

PubMed Central

Festin, Mario P.R.; Bahamondes, Luis; Nguyen, Thi My Huong; Habib, Ndema; Thamkhantho, Manopchai; Singh, Kuldip; Gosavi, Arundhati; Bartfai, Gyorgy; Bito, Tamas; Bahamondes, M. Valeria; Kapp, Nathalie

2016-01-01

STUDY QUESTION Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? SUMMARY ANSWER Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. WHAT IS KNOWN ALREADY LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. STUDY DESIGN, SIZE, DURATION This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 330 healthy fertile women aged 18–45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability

Transvaginal radio frequency treatment of the endopelvic fascia: a prospective evaluation for the treatment of genuine stress urinary incontinence.

PubMed

Dmochowski, Roger R; Avon, Mark; Ross, James; Cooper, Jay M; Kaplan, Richard; Love, Beverly; Kohli, NeeraJ; Albala, David; Shingleton, Bruce

2003-03-01

We evaluate the safety and efficacy of a new treatment modality for genuine stress urinary incontinence which was a transvaginal radio frequency applicator to deliver radio frequency energy to the endopelvic fascia. The purported mechanism of effect for this therapy is shrinkage of the collagenated tissue which composes the endopelvic fascia that supports the bladder neck and proximal urethra, thus stabilizing the proximal urethra and bladder neck. In prior animal trials and early pilot studies this therapy was shown to cause a reproducible thermal effect manifested by fascial shrinkage. Preliminary human trials indicated a therapeutic benefit of this therapy for women with genuine stress urinary incontinence. To our knowledge this is the first multicenter study of a transvaginal approach for radio frequency of the endopelvic fascia for treatment of genuine stress incontinence. Between June 1999 and June 2000, 120 consecutive women (mean age 49.9 years) at 10 sites underwent transvaginal radio frequency treatment in a prospective trial to evaluate the overall efficacy and safety profile of this therapy. All patients had preoperative urethral hypermobility (average cotton swab change 38 degrees). Detrusor instability was excluded by cystometry. In all procedures precisely controlled radio frequency energy was applied to the endopelvic fascia to heat and shrink the tissue. The patients were evaluated postoperatively at 1 week and at 1, 3, 6 and 12 months using objective and subjective measures. Primary end points consisted of physician assessment of continence, patient reported pad use and the number of patient reported episodes. Safety was determined for acute (immediate postoperative) and chronic time frames. Of the 120 patients 96 completed 1-year evaluation. Average operative time was less than 30 minutes, and all patients were treated as outpatients. Preoperatively 101 patients (84%) averaged 1 or more episodes of urinary incontinence per day. At 3, 6 and 12

Improving decision making in multidisciplinary tumor boards: prospective longitudinal evaluation of a multicomponent intervention for 1,421 patients.

PubMed

Lamb, Benjamin W; Green, James S A; Benn, Jonathan; Brown, Katrina F; Vincent, Charles A; Sevdalis, Nick

2013-09-01

Due to its complexity, cancer care is increasingly being delivered by multidisciplinary tumor boards (MTBs). Few studies have investigated how best to organize and run MTBs to optimize clinical decision making. We developed and evaluated a multicomponent intervention designed to improve the MTB's ability to reach treatment decisions. We conducted a prospective longitudinal study during 16 months that evaluated MTB decision making for urological cancer patients at a university hospital in London, UK. After a baseline period, MTB improvement interventions (eg, MTBs checklist, MTB team training, and written guidance) were delivered sequentially. Outcomes measures were the MTB's ability to reach a decision, the quality of information presentation, and the quality of teamwork (as assessed by trained assessors using a previously validated observational assessment tool). The efficacy of the intervention was evaluated using multivariate analyses. There were 1,421 patients studied between December 2009 and April 2, 2011. All outcomes improved considerably between baseline and intervention implementation: the MTB's ability to reach a decision rose from 82.2% to 92.7%, quality of information presentation rose from 29.6% to 38.3%, and quality of teamwork rose from 37.8% to 43.0%. The MTB's ability to reach a treatment decision was related to the quality of available information (r = 0.298; p < 0.05) and quality of teamwork within the MTB (r = 0.348; p < 0.05). The most common barriers to reaching clinical decisions were inadequate radiologic information (n = 77), inadequate pathologic information (n = 51), and inappropriate patient referrals (n = 21). Multidisciplinary tumor board-delivered treatment is becoming the standard for cancer care worldwide. Our intervention is efficacious and applicable to MTBs and can improve decision making and expedite cancer care. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Efficacy of site-independent telemedicine in the STRokE DOC trial: a randomised, blinded, prospective study

PubMed Central

Meyer, Brett C.; Raman, Rema; Hemmen, Thomas; Obler, Richard; Zivin, Justin A.; Rao, Ramesh; Thomas, Ronald G.; Lyden, Patrick D.

2009-01-01

Background To increase effective use of rt-PA for acute stroke, vascular neurology expertise must be disseminated more widely. We prospectively assessed whether telemedicine (real-time, 2 way audio/video and DICOM interpretation) or telephone was superior for decision-making in acute telemedicine consultations. Methods Acute stroke patients were randomized to telemedicine or telephone consultation. Primary outcome measure was whether the thrombolytic treatment decision was correct, as determined by central adjudication. Secondary outcomes included rt-PA use-rate, 90 day functional outcomes, hemorrhages, and technical observations. Findings Two hundred thirty-four patients were prospectively evaluated. Mean NIHSS score was 9.5 (11.4±8.7 telemedicine, 7.7±7.0 telephone; p=0.0020). One telemedicine consult (0.9%) was aborted for technical reasons, though was included in intention-to-treat analyses. Correct treatment decision was made more often in telemedicine (98.2% telemedicine, 82% telephone; OR 10.9; 95%CI 2.7-44.6; p=0.0009). IV rt-PA use-rate was 25% (28% telemedicine, 23% telephone; OR 1.3; 95%CI 0.7-2.5; p=0.4248). Ninety day functional outcomes were not different for BI(95–100) (OR 0.6; 95%CI 0.4-1.1; p=0.1268) or for mRS (OR 0.6; 95%CI 0.3-1.1; p=0.0898). There was no mortality difference (OR 1.6; 95%CI 0.8-3.4; p=0.2690). Post-rt-PA ICH rates were not different (7% telemedicine, 8% telephone; OR 0.8; 95%CI 0.1-6.3; p=1.0). There was a difference noted for amount of non-completed data (3.1% telemedicine, 12.0% telephone; OR 0.2; 95%CI 0.1-0.3; p<0.001). Interpretation This trial reports that stroke telemedicine consultations result in more accurate decision making, compared to telephone, and can serve as a model for the effective use of telemedicine in other medical fields. The more appropriate decisions, high rt-PA userates, improved data collection, low ICH rates, low technical complications, and favorable time requirements all support telemedicine�

Algorithms for detecting and predicting influenza outbreaks: metanarrative review of prospective evaluations

PubMed Central

Spreco, A; Timpka, T

2016-01-01

Objectives Reliable monitoring of influenza seasons and pandemic outbreaks is essential for response planning, but compilations of reports on detection and prediction algorithm performance in influenza control practice are largely missing. The aim of this study is to perform a metanarrative review of prospective evaluations of influenza outbreak detection and prediction algorithms restricted settings where authentic surveillance data have been used. Design The study was performed as a metanarrative review. An electronic literature search was performed, papers selected and qualitative and semiquantitative content analyses were conducted. For data extraction and interpretations, researcher triangulation was used for quality assurance. Results Eight prospective evaluations were found that used authentic surveillance data: three studies evaluating detection and five studies evaluating prediction. The methodological perspectives and experiences from the evaluations were found to have been reported in narrative formats representing biodefence informatics and health policy research, respectively. The biodefence informatics narrative having an emphasis on verification of technically and mathematically sound algorithms constituted a large part of the reporting. Four evaluations were reported as health policy research narratives, thus formulated in a manner that allows the results to qualify as policy evidence. Conclusions Awareness of the narrative format in which results are reported is essential when interpreting algorithm evaluations from an infectious disease control practice perspective. PMID:27154479

Prospective payment based on case mix: will it work in nursing homes?

PubMed

Rosko, M D; Broyles, R W; Aaronson, W E

1987-01-01

This article evaluates the potential efficacy of implementing a prospective payment system based on case mix in the nursing home industry. The analysis of structural differences between the nursing home and hospital industries suggests that the mechanism of compensating long-term care facilities should be based on functional health status rather than on diagnosis and that incentives to improve quality and access should be strengthened. The article assesses several systems of classifying patients that have been proposed as the basis for implementing a prospective payment system in the nursing home industry. The article concludes with a discussion of policy issues related to the appropriate unit of payment and the scope of regulatory authority.

Longitudinal evaluation of the efficacy of heat treatment procedures against Legionella spp. in hospital water systems by using a flow cytometric assay.

PubMed

Allegra, Severine; Grattard, Florence; Girardot, Françoise; Riffard, Serge; Pozzetto, Bruno; Berthelot, Philippe

2011-02-01

Legionella spp. are frequently isolated in hospital water systems. Heat shock (30 min at 70°C) is recommended by the World Health Organization to control its multiplication. The aim of the study was to evaluate retrospectively the efficacy of heat treatments by using a flow cytometry assay (FCA) able to identify viable but nonculturable (VBNC) cells. The study included Legionella strains (L. pneumophila [3 clusters] and L. anisa [1 cluster]) isolated from four hot water circuits of different hospital buildings in Saint-Etienne, France, during a 20-year prospective surveillance. The strains recovered from the different circuits were not epidemiologically related, but the strains isolated within a same circuit over time exhibited an identical genotypic profile. After an in vitro treatment of 30 min at 70°C, the mean percentage of viable cells and VBNC cells varied from 4.6% to 71.7%. The in vitro differences in heat sensitivity were in agreement with the observed efficacy of preventive and corrective heating measures used to control water contamination. These results suggest that Legionella strains can become heat resistant after heating treatments for a long time and that flow cytometry could be helpful to check the efficacy of heat treatments on Legionella spp. and to optimize the decontamination processes applied to water systems for the control of Legionella proliferation.

Prospective Evaluation of Self-Reported Aggression in Transgender Persons.

PubMed

Defreyne, Justine; T'Sjoen, Guy; Bouman, Walter Pierre; Brewin, Nicola; Arcelus, Jon

2018-05-01

from friends in transgender women. Hormone-prescribing physicians can be reassured that the long-term administration of testosterone in transgender men does not increase aggressive behavior. This is the 1st prospective study to assess the effect of gender-affirming hormonal care on aggression. Limitations included the use of different laboratories, the use of a patient-reported outcome measure, and the lack of aggression subtypes. Testosterone therapy was not associated with an increase in levels of aggression in transgender men or a decrease in aggressive behavior in transgender women on antiandrogen and estrogen therapy, but other psychological and/or social factors, such as anxiety levels, appear to contribute to self-reported aggression in transgender people. Defreyne J, T'Sjoen G, Bouman WP, et al. Prospective Evaluation of Self-Reported Aggression in Transgender Persons. J Sex Med 2018;15:768-776. Copyright © 2018 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Acute Transient Vestibular Syndrome: Prevalence of Stroke and Efficacy of Bedside Evaluation.

PubMed

Choi, Jae-Hwan; Park, Min-Gyu; Choi, Seo Young; Park, Kyung-Pil; Baik, Seung Kug; Kim, Ji-Soo; Choi, Kwang-Dong

2017-03-01

The aim of this study was to determine the prevalence of stroke and efficacy of bedside evaluation in diagnosing stroke in acute transient vestibular syndrome (ATVS). We performed a prospective, single-center, observational study that had consecutively recruited 86 patients presenting with ATVS to the emergency department of Pusan National University Yangsan Hospital from January to December 2014. All patients received a constructed evaluation, including HINTS plus (head impulse, nystagmus patterns, test of skew, and finger rubbing) and brain magnetic resonance imagings. Patients without an obvious cause further received perfusion-weighted imaging. Multivariable logistic regression was used to determine clinical parameters to identify stroke in ATVS. The prevalence of stroke was 27% in ATVS. HINTS plus could not be applied to the majority of patients because of the resolution of the vestibular symptoms, and magnetic resonance imagings were falsely negative in 43% of confirmed strokes. Ten patients (12%) showed unilateral cerebellar hypoperfusion on perfusion-weighted imaging without an infarction on diffusion-weighted imaging, and 8 of them had a focal stenosis or hypoplasia of the corresponding vertebral artery. The higher risk of stroke in ATVS was found in association with craniocervical pain (odds ratio, 9.6; 95% confidence interval, 2.0-45.2) and focal neurological symptoms/signs (odds ratio, 15.2; 95% confidence interval, 2.5-93.8). Bedside examination and routine magnetic resonance imagings have a limitation in diagnosing strokes presenting with ATVS, and perfusion imaging may help to identify strokes in ATVS of unknown cause. Associated craniocervical pain and focal neurological symptoms/signs are the useful clues for strokes in ATVS. © 2017 American Heart Association, Inc.

Leflunomide in active rheumatoid arthritis: a prospective study in daily practice.

PubMed

Van Roon, E N; Jansen, T L Th A; Mourad, L; Houtman, P M; Bruyn, G A W; Griep, E N; Wilffert, B; Tobi, H; Brouwers, J R B J

2004-08-01

We prospectively studied the efficacy, incidence of adverse drug reactions and withdrawal from leflunomide in an outpatient population with rheumatoid arthritis in a setting of care-as-usual. In this prospective case series study, a standard dataset was collected from outpatient medical records, including patient and disease characteristics, data on leflunomide use and adverse drug reactions. During the study period 136 rheumatoid arthritis patients started leflunomide. Median (range) follow-up duration was 317 (11-911) days. Sixty-five percent of patients experienced at least one adverse drug reaction related to leflunomide. During follow-up 76 patients (56%) withdrew from leflunomide treatment, mainly because of adverse drug reactions (29%) or lack of efficacy (13%). The overall incidence density for withdrawal from leflunomide was 56.2 per 100 patient years. Complete data for calculating efficacy using a validated disease activity score on 28 joints (DAS(28)) was available for 48, 36, and 35% of patients at 2, 6, and 12 months follow-up, respectively. Within a 12-month period after start of leflunomide treatment 76% of the evaluable patients were classified as moderate or good responders according to the DAS(28) response criteria. In the setting of care-as-usual rheumatoid arthritis patients starting leflunomide frequently experienced adverse drug reactions. More than half of the patients withdrew from leflunomide treatment within 1 year of starting leflunomide treatment, mainly because of adverse drug reactions.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

PubMed

Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

2016-12-01

The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

Time-dependent efficacy of longitudinal biomarker for clinical endpoint.

PubMed

Kolamunnage-Dona, Ruwanthi; Williamson, Paula R

2018-06-01

Joint modelling of longitudinal biomarker and event-time processes has gained its popularity in recent years as they yield more accurate and precise estimates. Considering this modelling framework, a new methodology for evaluating the time-dependent efficacy of a longitudinal biomarker for clinical endpoint is proposed in this article. In particular, the proposed model assesses how well longitudinally repeated measurements of a biomarker over various time periods (0,t) distinguish between individuals who developed the disease by time t and individuals who remain disease-free beyond time t. The receiver operating characteristic curve is used to provide the corresponding efficacy summaries at various t based on the association between longitudinal biomarker trajectory and risk of clinical endpoint prior to each time point. The model also allows detecting the time period over which a biomarker should be monitored for its best discriminatory value. The proposed approach is evaluated through simulation and illustrated on the motivating dataset from a prospective observational study of biomarkers to diagnose the onset of sepsis.

Quantitative framework for prospective motion correction evaluation.

PubMed

Pannetier, Nicolas A; Stavrinos, Theano; Ng, Peter; Herbst, Michael; Zaitsev, Maxim; Young, Karl; Matson, Gerald; Schuff, Norbert

2016-02-01

Establishing a framework to evaluate performances of prospective motion correction (PMC) MRI considering motion variability between MRI scans. A framework was developed to obtain quantitative comparisons between different motion correction setups, considering that varying intrinsic motion patterns between acquisitions can induce bias. Intrinsic motion was considered by replaying in a phantom experiment the recorded motion trajectories from subjects. T1-weighted MRI on five volunteers and two different marker fixations (mouth guard and nose bridge fixations) were used to test the framework. Two metrics were investigated to quantify the improvement of the image quality with PMC. Motion patterns vary between subjects as well as between repeated scans within a subject. This variability can be approximated by replaying the motion in a distinct phantom experiment and used as a covariate in models comparing motion corrections. We show that considering the intrinsic motion alters the statistical significance in comparing marker fixations. As an example, two marker fixations, a mouth guard and a nose bridge, were evaluated in terms of their effectiveness for PMC. A mouth guard achieved better PMC performance. Intrinsic motion patterns can bias comparisons between PMC configurations and must be considered for robust evaluations. A framework for evaluating intrinsic motion patterns in PMC is presented. © 2015 Wiley Periodicals, Inc.

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

PubMed

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

2016-11-09

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

A prospective observational study evaluating the efficacy of prophylactic internal iliac artery balloon catheterization in the management of placenta previa–accreta

PubMed Central

Fan, Yao; Gong, Xun; Wang, Nan; Mu, Ketao; Feng, Ling; Qiao, Fuyuan; Chen, Suhua; Zeng, Wanjiang; Liu, Haiyi; Wu, Yuanyuan; Zhou, Qiong; Tian, Yuan; Li, Qiang; Yang, Meitao; Li, Fanfan; He, Mengzhou; Beejadhursing, Rajluxmee; Deng, Dongrui

2017-01-01

Abstract We studied the efficacy of prophylactic internal iliac artery balloon catheterization for managing severe hemorrhage caused by pernicious placenta previa. This prospective observational study was conducted in Tongji Hospital, Wuhan, China. One hundred sixty-three women past 32-week's gestation with placenta previa–accreta were recruited and managed. Women in the balloon group accepted prophylactic internal iliac artery balloon catheterization before scheduled caesarean delivery and controls had a conventional caesarean delivery. Intraoperative hemorrhage, transfusion volume, radiation dose, exposure time, complications, and neonatal outcomes were discussed. Significant differences were detected in estimated blood loss (1236.0 mL vs 1694.0 mL, P = .01), calculated blood loss (CBL) (813.8 mL vs 1395.0 mL, P < .001), CBL of placenta located anteriorly (650.5 mL vs 1196.0 mL, P = .03), and anterioposteriorly (928.3 mL vs 1680.0 mL, P = .02). Prophylactic balloon catheterization could reduce intraoperative red blood cell transfusion (728.0 mL vs 1205.0 mL, P = .01) and lessen usage of perioperative hemostatic methods. The incidence of hysterectomy was lower in balloon group. Mean radiation dose was 29.2 mGy and mean exposure time was 92.2 seconds. Neonatal outcomes and follow-up data did not have significant difference. Prophylactic internal iliac artery balloon catheterization is an effective method for managing severe hemorrhage caused by placenta previa–accreta as it reduced intraoperative blood loss, lessened perioperative hemostatic measures and intraoperative red cell transfusions, and reduce hysterectomies. PMID:29137011

The Evaluation of the Opinions of Prospective Teachers about the Objectives of Human Rights Education

ERIC Educational Resources Information Center

Özbek, Ramazan

2017-01-01

The aim of this study is to evaluate opinions of prospective teachers attending Social Sciences Teaching Department Primary Education Section on the objectives of Human Rights Education in the scope of Citizenship and Democracy Education Curriculum. This study is vital for learning of democratic life. 25 prospective teachers studying in the 8th…

Prospective evaluation of biodegradable polymeric sealant for intraoperative air leaks.

PubMed

Park, Bernard J; Snider, John M; Bates, Nathan R; Cassivi, Stephen D; Jett, G Kimble; Sonett, Joshua R; Toloza, Eric M

2016-12-12

A biodegradable polymeric sealant has been previously shown to reduce postoperative air leaks after open pulmonary resection. The aim of this study was to evaluate safety and efficacy during minimally invasive pulmonary resection. In a multicenter prospective single-arm trial, 112 patients with a median age of 69 years (range 34-87 years) were treated with sealant for at least one intraoperative air leak after standard methods of repair (sutures, staples or cautery) following minimally invasive pulmonary resection (Video-Assisted Thoracic Surgery (VATS) or Robotic-Assisted). Patients were followed in hospital and 1 month after surgery for procedure-related and device-related complications and presence of air leak. Forty patients had VATS and 72 patients had Robotic-Assisted procedures with the majority (80/112, 71%) undergoing anatomic resection (61 lobectomy, 13 segmentectomy, 6 bilobectomy). There were no device-related adverse events. The overall morbidity rate was 41% (46/112), with major complications occurring in 16.1% (18/112). In-hospital mortality and 30-day mortality were 1.9% (2/103). The majority of intraoperative air leaks (107/133, 81%) were sealed after sealant application, and an additional 16% (21/133) were considered reduced. Forty-nine percent of patients (55/112) were free of air leak throughout the entire postoperative study period. Median chest tube duration was 2 days (range 1 - 46 days), and median length of hospitalization was 3 days (range 1 - 20 days). This study demonstrated that use of a biodegradable polymer for closure of intraoperative air leaks as an adjunct to standard methods is safe and effective following minimally invasive pulmonary resection. ClinicalTrials.gov: NCT01867658 . Registered 3 May 2013.

Treating Small Bowel Obstruction with a Manual Physical Therapy: A Prospective Efficacy Study

PubMed Central

Rice, Amanda D.; Patterson, Kimberley; Reed, Evette D.; Wurn, Belinda F.; Klingenberg, Bernhard; King, C. Richard; Wurn, Lawrence J.

2016-01-01

Small bowel obstructions (SBOs) caused by adhesions are a common, often life-threatening postsurgical complication with few treatment options available for patients. This study examines the efficacy of a manual physical therapy treatment regimen on the pain and quality of life of subjects with a history of bowel obstructions due to adhesions in a prospective, controlled survey based study. Changes in six domains of quality of life were measured via ratings reported before and after treatment using the validated Small Bowel Obstruction Questionnaire (SBO-Q). Improvements in the domains for pain (p = 0.0087), overall quality of life (p = 0.0016), and pain severity (p = 0.0006) were significant when average scores before treatment were compared with scores after treatment. The gastrointestinal symptoms (p = 0.0258) domain was marginally significant. There was no statistically significant improvement identified in the diet or medication domains in the SBO-Q for this population. Significant improvements in range of motion in the trunk (p ≤ 0.001), often limited by adhesions, were also observed for all measures. This study demonstrates in a small number of subjects that this manual physical therapy protocol is an effective treatment option for patients with adhesive small bowel obstructions as measured by subject reported symptoms and quality of life. PMID:26989690

Prospective evaluation of the clinical utility of laryngeal electromyography.

PubMed

Ingle, John W; Young, VyVy N; Smith, Libby J; Munin, Micheal C; Rosen, Clark A

2014-12-01

To prospectively evaluate the clinical utility of laryngeal electromyography (LEMG) STUDY DESIGN: Prospective observational study. The study involved 50 consecutive patients referred for LEMG. Laryngologists initially indicated diagnoses and treatment plans under the assumption of no access to LEMG. Patients then underwent LEMG by blinded examiners. LEMG results were reviewed by each patient's laryngologist. Diagnoses and treatment plans were either maintained or altered based on the LEMG results. The diagnosis changed 10% (5/50) of the time and treatment plans were altered 36% (18/50) of the time based on information provided by LEMG. Observational periods were eliminated in 13/50 patients based on LEMG, moving them to permanent treatment. LEMG allowed the differentiation between joint fixation and bilateral paralysis in three patients. Previously unrecognized superior laryngeal neuropathies were identified in three patients. Laryngeal electromyography often provides clinically useful information that typically leads to a more accurate diagnosis and a more appropriate, expedited treatment plan. 2b. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Efficacy and Safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma: A prospective observation study.

PubMed

Yu, Wen-Chang; Zhang, Kong-Zhi; Chen, Shi-Guang; Liu, Wei-Fu

2018-01-01

This prospective study aimed to evaluate the efficacy and safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma (HCC).The patients with intermediate/advanced HCC, who met predetermined inclusion and exclusion criteria, underwent oral treatment of apatinib 500 mg daily. The drug-related adverse effects were monitored by regular follow-up and workup including laboratory tests and imaging examinations. Tumor response was assessed by response evaluation criteria in solid tumor criteria. The time to tumor progression (TTP) and overall survival rate (OS) were calculated using the Kaplan-Meier method.A total of 31 patients were enrolled in the study from October 28, 2015 to December 28, 2016. The number of patients with intermediate and advanced HCC was 4 (12.90%) and 27 (87.10%), respectively. The mean tumor size was 9.47 ± 5.48 cm (range: 1.2-19 cm). Vascular invasion was seen in 14 patients (45.16%). A total of 21 (67.74%) patients exhibited extrahepatic metastases. On the basis of first follow-up computed tomography and magnetic resonance imaging at 6 weeks after treatment, 10 (32.26%), 15 (48.39%), and 6 (19.35%) of 31 patients achieved a partial response, stable disease, and progression of disease, respectively. Response rate and disease control rate were 32.26% and 80.65%, respectively. The median TTP was 4.8 months (95% confidence interval: 3.75-5.86 months). Furthermore, 6- and 12-month OS rates were 73.8% and 55.4%, respectively. Grade 3 thrombocytopenia (6.45%) and hypertension (48.39%) were the most common hematologic and nonhematologic toxicities. Grade 3 elevation of either serum total bilirubin or aminotransferase (6.45%) was observed as the top incidence among important indexes of liver function.Our preliminary findings suggest apatinib is a safe and effective therapy in intermediate/advanced HCC patients with high tumor response and survival rates. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc

Efficacy and Safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma: A prospective observation study

PubMed Central

Yu, Wen-Chang; Zhang, Kong-Zhi; Chen, Shi-Guang; Liu, Wei-Fu

2018-01-01

Abstract This prospective study aimed to evaluate the efficacy and safety of apatinib in patients with intermediate/advanced hepatocellular carcinoma (HCC). The patients with intermediate/advanced HCC, who met predetermined inclusion and exclusion criteria, underwent oral treatment of apatinib 500 mg daily. The drug-related adverse effects were monitored by regular follow-up and workup including laboratory tests and imaging examinations. Tumor response was assessed by response evaluation criteria in solid tumor criteria. The time to tumor progression (TTP) and overall survival rate (OS) were calculated using the Kaplan–Meier method. A total of 31 patients were enrolled in the study from October 28, 2015 to December 28, 2016. The number of patients with intermediate and advanced HCC was 4 (12.90%) and 27 (87.10%), respectively. The mean tumor size was 9.47 ± 5.48 cm (range: 1.2–19 cm). Vascular invasion was seen in 14 patients (45.16%). A total of 21 (67.74%) patients exhibited extrahepatic metastases. On the basis of first follow-up computed tomography and magnetic resonance imaging at 6 weeks after treatment, 10 (32.26%), 15 (48.39%), and 6 (19.35%) of 31 patients achieved a partial response, stable disease, and progression of disease, respectively. Response rate and disease control rate were 32.26% and 80.65%, respectively. The median TTP was 4.8 months (95% confidence interval: 3.75–5.86 months). Furthermore, 6- and 12-month OS rates were 73.8% and 55.4%, respectively. Grade 3 thrombocytopenia (6.45%) and hypertension (48.39%) were the most common hematologic and nonhematologic toxicities. Grade 3 elevation of either serum total bilirubin or aminotransferase (6.45%) was observed as the top incidence among important indexes of liver function. Our preliminary findings suggest apatinib is a safe and effective therapy in intermediate/advanced HCC patients with high tumor response and survival rates. PMID:29505026

Efficacy and safety of ultrasound-guided percutaneous polidocanol sclerotherapy in benign predominantly cystic thyroid nodules: a prospective study.

PubMed

Gong, Xiaohua; Zhou, Qi; Chen, Shuoping; Wang, Fang; Wu, Wenjun; Chen, Xiaojun

2017-08-01

To evaluate the efficacy and safety of percutaneous polidocanol injection (PPI) in treatment of predominantly cystic thyroid nodules. This prospective study included 111 patients with 122 benign predominantly cystic thyroid nodules inducing pressure symptoms or cosmetic problems. The nodules were randomized to a single aspiration with (n = 61) or without (n = 61) subsequent PPI and followed up after 1, 3, 6, and 12 months. Ten patients (12 nodules) declined to follow up after aspiration in group 2. Nodule volumes, symptoms scores, and cosmetic scores were evaluated before and after treatment. The therapeutic success rate and safety of PPI for treatment of predominantly cystic thyroid nodules were also evaluated. In the PPI group, the nodule volumes were reduced from 13.67 ± 9.90 to 2.60 ± 2.66 (p < .001). Therapeutic success rate (nodule volume reduction >50%) was obtained in 57 of 61 (93.44%) nodules in the PPI group, compared to seven of 49 (14.29%) in the aspiration group (p < .001). In the aspiration group, the nodule volume was not significantly reduced. The reduction in symptom scores was significantly higher in the PPI group (from 3.60 ± 1.65 to 1.60 ± 1.19) than in the aspiration group (from 3.62 ± 1.89 to 3.30 ± 1.06) (p < .001, between groups). The reduction in cosmetic scores showed a significant difference between groups (p < .001). In total, 4.92% of patients (3/61) in the PPI group and 85.71% (42/49) in the aspiration group showed recurrence during the follow-up period. There was a significant difference in the recurrence rate between groups (p < .001). No major side-effects occurred. US-guided PPI of benign recurrent predominantly cystic thyroid nodules is effective and safe. PPI is an important alternative to benign recurrent predominantly cystic thyroid nodules.

Leflunomide in active rheumatoid arthritis: a prospective study in daily practice.

PubMed

Van Roon, E N; Jansen, T L Th A; Mourad, L; Houtman, P M; Bruyn, G A W; Griep, E N; Wilffert, B; Tobi, H; Brouwers, J R B J

2004-06-01

We prospectively studied the efficacy, incidence of adverse drug reactions and withdrawal from leflunomide in an outpatient population with rheumatoid arthritis in a setting of care-as-usual. In this prospective case series study, from outpatient medical records a standard dataset was collected including patient and disease characteristics, data on leflunomide use and adverse drug reactions. During the study period 136 rheumatoid arthritis patients started leflunomide. Median (range) follow-up duration was 317 (11-911) days. Sixty-five percent of patients experienced at least one adverse drug reaction related to leflunomide. During follow-up 76 patients (56%) withdrew from leflunomide treatment, mainly because of adverse drug reactions (29%) or lack of efficacy (13%). The overall incidence density for withdrawal from leflunomide was 56.2 per 100 patient-years. Complete data for calculating efficacy using a validated disease activity score on 28 joints (DAS(28)) was available for 48, 36, and 35% of patients at 2, 6, and 12 months follow-up, respectively. Within a 12-month period after start of leflunomide treatment 76% of the evaluable patients were classified as moderate or good responders according to the DAS(28) response criteria. In the setting of care-as-usual, rheumatoid arthritis patients starting leflunomide frequently experienced adverse drug reactions. More than half of the patients withdrew from leflunomide treatment within a year after start of leflunomide treatment, mainly because of adverse drug reactions.

Evaluation of the Alexon-Trend ProSpecT Campylobacter Microplate Assay

PubMed Central

Tolcin, Rita; LaSalvia, Margaret M.; Kirkley, Barbara A.; Vetter, Emily A.; Cockerill, Franklin R.; Procop, Gary W.

2000-01-01

We evaluated stool specimens known to contain or be free of Campylobacter by traditional culture, using the ProSpecT Campylobacter microplate assay (Alexon-Trend, Ramsey, Minn.). This rapid enzyme immunoassay for the detection of Campylobacter-specific antigens demonstrated 96% sensitivity and 99% specificity and is an acceptable alternative method of Campylobacter detection. PMID:11015419

Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

ERIC Educational Resources Information Center

Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

2011-01-01

We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

A potential role for imaging technology in anticancer efficacy evaluations.

PubMed

Hollingshead, M G; Bonomi, C A; Borgel, S D; Carter, J P; Shoemaker, R; Melillo, G; Sausville, E A

2004-04-01

The introduction of imaging methods suitable for rodents offers opportunities for new anticancer efficacy models. Traditional models do not provide the level of sensitivity afforded by these precise and quantitative techniques. Bioluminescent endpoints, now feasible because of sensitive charge-coupled device cameras, can be non-invasively detected in live animals. Currently, the most common luminescence endpoint is firefly luciferase, which, in the presence of O(2) and ATP, catalyses the cleavage of the substrate luciferin and results in the emission of a photon of light. In vivo implantation of tumour cells transfected with the luciferase gene allows sequential monitoring of tumour growth within the viscera by measuring these photon signals. Furthermore, tumour cell lines containing the luciferase gene transcribed from an inducible promoter offer opportunities to study molecular-target modulation without the need for ex vivo evaluations of serial tumour samples. In conjunction with this, transgenic mice bearing a luciferase reporter mechanism can be used to monitor the tumour microenvironment as well as to signal when transforming events occur. This technology has the potential to reshape the efficacy evaluations and drug-testing algorithms of the future.

Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI).

PubMed

Kuzman, Ilija; Bezlepko, Alexandr; Kondova Topuzovska, Irena; Rókusz, László; Iudina, Liudmyla; Marschall, Hans-Peter; Petri, Thomas

2014-06-30

Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide. Management of CAP for many patients requires rapid initiation of empirical antibiotic treatment, based on the spectrum of activity of available antimicrobial agents and evidence on local antibiotic resistance. Few data exist on the severity profile and treatment of hospitalized CAP patients in Eastern and Central Europe and the Middle East, in particular on use of moxifloxacin (Avelox®), which is approved in these regions. CAPRIVI (Community Acquired Pneumonia: tReatment wIth AVelox® in hospItalized patients) was a prospective observational study in 12 countries: Croatia, France, Hungary, Kazakhstan, Jordan, Kyrgyzstan, Lebanon, Republic of Moldova, Romania, Russia, Ukraine, and Macedonia. Patients aged >18 years were treated with moxifloxacin 400 mg daily following hospitalization with a CAP diagnosis. In addition to efficacy and safety outcomes, data were collected on patient history and disease severity measured by CRB-65 score. 2733 patients were enrolled. A low severity index (i.e., CRB-65 score <2) was reported in 87.5% of CAP patients assessed (n=1847), an unexpectedly high proportion for hospitalized patients. Moxifloxacin administered for a mean of 10.0 days (range: 2.0 to 39.0 days) was highly effective: 96.7% of patients in the efficacy population (n=2152) improved and 93.2% were cured of infection during the study. Severity of infection changed from "moderate" or "severe" in 91.8% of patients at baseline to "no infection" or "mild" in 95.5% at last visit. In the safety population (n=2595), 127 (4.9%) patients had treatment-emergent adverse events (TEAEs) and 40 (1.54%) patients had serious TEAEs; none of these 40 patients died. The safety results were consistent with the known profile of moxifloxacin. The efficacy and safety profiles of moxifloxacin at the recommended dose of 400 mg daily are characterized in this large observational study of

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.

A prospective study on the efficacy of two-dose influenza vaccinations in cancer patients receiving chemotherapy.

PubMed

Sanada, Yukinari; Yakushijin, Kimikazu; Nomura, Tetsuhiko; Chayahara, Naoko; Toyoda, Masanori; Minami, Yosuke; Kiyota, Naomi; Mukohara, Toru; Kawamoto, Shinichiro; Ito, Mitsuhiro; Matsuoka, Hiroshi; Minami, Hironobu

2016-05-01

Cancer patients receiving chemotherapy are at risk of acquiring influenza infections. Two-dose vaccination is a proposed strategy for increasing vaccination efficacy; however, this has yet to be confirmed in this population. The purpose of this study was to clarify the efficacy and safety of this strategy. We conducted a multicentre prospective study on a two-dose vaccination regimen in cancer patients receiving chemotherapy. Second vaccinations were performed in patients who did not respond to all three viral strains after the first vaccination. Serum haemagglutination inhibition titres were measured to determine the patients' immunological response, 2 weeks prior to the first vaccination, 3-5 weeks after each vaccination, and at the end of the influenza season. We enrolled 109 patients, including 70 with solid tumours, 36 with haematological malignancies, and 3 with both cancer types. Among the total patients, the proportion of patients with protective titres against the three viral strains increased significantly from 3 to 27% (P < 0.01) following vaccination. Among the 79 patients who received a second vaccination, the proportion of those with protective titres against the individual strains increased by 10% (H1N1), 8% (H3N2), and 3% (B) compared with after the first vaccination. Serious adverse events were not observed. We recommend influenza vaccinations for cancer patients, including those receiving chemotherapy. Also, the additional benefit of the second vaccination may be limited. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Sublingual immunotherapy in patients with house dust mite allergic rhinitis: prospective study of clinical outcomes over a two-year period.

PubMed

Soh, J Y; Thalayasingam, M; Ong, S; Loo, E X L; Shek, L P; Chao, S S

2016-03-01

Sublingual immunotherapy in patients with allergic rhinitis sensitised to house dust mites is safe, but its efficacy is controversial and sublingual immunotherapy with Blomia tropicalis has not yet been studied. This study sought to evaluate the efficacy of sublingual immunotherapy with house dust mite extract in children and adults with house dust mite allergic rhinitis over a period of two years. A prospective observational study was conducted of children and adults diagnosed with house dust mite allergic rhinitis who were treated with sublingual immunotherapy from 2008 to 2012. Total Nasal Symptom Scores, Mini Rhinoconjunctivitis Quality of Life scores and medication usage scores were assessed prospectively. Thirty-nine patients, comprising 24 children and 15 adults, were studied. Total Nasal Symptom Scores and Mini Rhinoconjunctivitis Quality of Life scores dropped significantly at three months into therapy, and continued to improve. Medication usage scores improved at one year into immunotherapy. Sublingual immunotherapy with house dust mite extracts, including B tropicalis, is efficacious as a treatment for patients with house dust mite allergic rhinitis.

Biomarker Evaluation Does Not Confirm Efficacy of Computer-Tailored Nutrition Education

ERIC Educational Resources Information Center

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

2011-01-01

Objective: To evaluate the efficacy of computer-tailored nutrition education with objective outcome measures. Design: A 3-group randomized, controlled trial with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam. Participants: A convenience sample of healthy Dutch adults (n = 442).…

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

Pre-Service Teachers' Retrospective and Prospective Evaluations: Program, Self, and Teaching Profession

ERIC Educational Resources Information Center

Ulusoy, Mustafa

2015-01-01

This study aimed to investigate teacher candidates' retrospective and prospective evaluations about the classroom teacher education program, self, and the teaching profession. Observations, interviews, focus group interviews, and surveys were used to collect data from the 240 subjects. Teacher candidates believed that the teaching profession is…

Prospective, open-label, uncontrolled pilot study to study safety and efficacy of sildenafil in systemic sclerosis-related pulmonary artery hypertension and cutaneous vascular complications.

PubMed

Kumar, Uma; Sankalp, Gokhale; Gokhle, Sankalp S; Sreenivas, V; Kaur, Satbir; Misra, Durgaprasanna

2013-04-01

Pulmonary artery hypertension (PAH) remains the leading cause of morbidity and mortality in systemic sclerosis, while Raynaud's phenomenon and digital ulcers significantly add to the morbidity in systemic sclerosis (SSc). This study was undertaken to evaluate the role of sildenafil in PAH, Raynaud's phenomenon, and digital ulcers in systemic sclerosis patients. A prospective, open-label, uncontrolled pilot study was done at a tertiary care centre in India to study the safety and efficacy of oral sildenafil in PAH, Raynaud's phenomenon, digital infarcts, and ulcers in SSc. Seventeen patients fulfilling ACR classification criteria for scleroderma and having PAH were recruited. Six-minute walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and 2D ECHO were performed in all the study subjects at baseline and at 3 months post-treatment. All patients were treated with oral sildenafil 25 mg three times a day for a period of 3 months. The pre- and post-treatment values of mean pulmonary artery pressure (PAP), 6-min walk test, WHO class of dyspnoea, and severity of Raynaud's phenomenon were compared to look for any significant change. Sixteen patients who completed 3-month follow-up had shown statistically significant improvement in 6-min walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and mPAP. Also, there was no occurrence of new digital infarcts or ulcers, and existing ulcers showed signs of healing. Sildenafil is highly efficacious cheaper and safe alternative to other available therapies for SSc-associated PAH, Raynaud's phenomenon, and digital infarcts/ulcers.

Prospective Evaluation of Few Homeopathic Rubrics of Kent's Repertory From Bayesian Perspective.

PubMed

Koley, Munmun; Saha, Subhranil; Das, Kaushik Deb; Roy, Sushabhan; Goenka, Rachna; Chowdhury, Pulak Roy; Hait, Himangsu; Bhattacharyya, Chapal Kanti; Sadhukhan, Sanjoy Kumar

2016-10-01

Absolute grading system of homeopathic repertories poses substantial threat to reliability; however, it may be resolved by evaluating rubrics prospectively using likelihood ratio (LR). The authors evaluated few "physical general" rubrics from Kent's repertory-"chilly," "hot," "ambithermal," "preference for hot/cold food," "desire/aversion for fish/egg/meat/sour/pungent/salt/sweet/bitter"-prospectively in West Bengal, India, for 1.5 years using the Outcome Related to Impact on Daily Living scale. Per symptom/rubric, LRs < 1.5 were discarded. A total of 2039 encounters were analyzed for thermal relations and 4715 for desires/aversions for specific food items. Comparison with Kent's repertory revealed discrepancies. One new rubric with corresponding medicines was suggested to be introduced, new entries of medicines were recommended, and some seemed to maintain their ascribed importance. The authors refrained from converting LRs into typefaces prematurely; still they propose introducing LR to repertories for a structural update, changing its use, and enabling homeopaths to make more reliable predictions. © The Author(s) 2015.

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.

The Relationship Between Regulatory Emotional Self-Efficacy and Core Self-Evaluation of College Students: The Mediation Effects of Suicidal Attitude.

PubMed

Zhao, Xiaojun; Shi, Changxiu

2018-01-01

This study analyzed the mediation effect of a suicidal attitude from regulatory emotional self-efficacy to core self-evaluation. A measurement study was conducted among 438 college students using the Regulatory Emotional Self-Efficacy Scale, the Core Self-Evaluation Scale, and the Suicide Attitude Questionnaire. Results from the plug-in process in SPSS and the bootstrap method showed that the attitude toward suicidal behavior and the attitude toward family members of an individual who has committed suicide played a double-mediation role, from perceived self-efficacy in managing happiness to core self-evaluation. The results also showed that the attitude toward a person who committed suicide or attempted suicide played a mediation effect from perceived self-efficacy in managing curiousness to core self-evaluation. This research has great significance for improving the understanding of college students' sense of happiness and prevention for self-evaluation.

The Relationship Between Regulatory Emotional Self-Efficacy and Core Self-Evaluation of College Students: The Mediation Effects of Suicidal Attitude

PubMed Central

Zhao, Xiaojun; Shi, Changxiu

2018-01-01

This study analyzed the mediation effect of a suicidal attitude from regulatory emotional self-efficacy to core self-evaluation. A measurement study was conducted among 438 college students using the Regulatory Emotional Self-Efficacy Scale, the Core Self-Evaluation Scale, and the Suicide Attitude Questionnaire. Results from the plug-in process in SPSS and the bootstrap method showed that the attitude toward suicidal behavior and the attitude toward family members of an individual who has committed suicide played a double-mediation role, from perceived self-efficacy in managing happiness to core self-evaluation. The results also showed that the attitude toward a person who committed suicide or attempted suicide played a mediation effect from perceived self-efficacy in managing curiousness to core self-evaluation. This research has great significance for improving the understanding of college students’ sense of happiness and prevention for self-evaluation. PMID:29740378

Assessment of the Safety and Efficacy of a Raft-Forming Alginate Reflux Suppressant (Liquid Gaviscon) for the Treatment of Heartburn during Pregnancy

PubMed Central

Strugala, Vicki; Bassin, Julian; Swales, Valerie S.; Lindow, Stephen W.; Dettmar, Peter W.; Thomas, Edward C. M.

2012-01-01

Gastro-oesophageal reflux (GER) and the symptoms of heartburn and regurgitation are common in pregnancy. These symptoms are transient and mostly resolve postpartum but have a negative impact on quality of life. Here, we present a prospective clinical evaluation of the safety and efficacy of an alginate raft-forming oral suspension that is licensed for use in pregnancy. The study was a multicentre, prospective, open-label, and baseline-controlled study of Liquid Gaviscon (LG) in the treatment of heartburn in pregnant women with current symptoms of heartburn and/or reflux requiring treatment (recruited 144). The efficacy of the study medication was rated by the investigator (primary endpoint) and patient. Treatment was deemed to be a success in 91% of patients as judged by the investigator (95% CI 85.0–95.3) and 90% (95% CI 84.1–94.8) when assessed by the patient themselves. Very few adverse events or serious adverse events were reported that were considered to be related to the study medication, and these were consistent with the normal population incidences. Serum sodium levels remained unchanged. This prospective open-label study in a large number of pregnant women has shown that LG is both safe and highly efficacious in the treatment of heartburn and GER symptoms in pregnancy. PMID:23209926

Prospect evaluation as a function of numeracy and probability denominator.

PubMed

Millroth, Philip; Juslin, Peter

2015-05-01

This study examines how numeracy and probability denominator (a direct-ratio probability, a relative frequency with denominator 100, a relative frequency with denominator 10,000) affect the evaluation of prospects in an expected-value based pricing task. We expected that numeracy would affect the results due to differences in the linearity of number perception and the susceptibility to denominator neglect with different probability formats. An analysis with functional measurement verified that participants integrated value and probability into an expected value. However, a significant interaction between numeracy and probability format and subsequent analyses of the parameters of cumulative prospect theory showed that the manipulation of probability denominator changed participants' psychophysical response to probability and value. Standard methods in decision research may thus confound people's genuine risk attitude with their numerical capacities and the probability format used. Copyright © 2015 Elsevier B.V. All rights reserved.

Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial.

PubMed

Gastelurrutia, Paloma; Gálvez-Montón, Carolina; Cámara, Maria Luisa; Bustamante-Munguira, Juan; García-Pavia, Pablo; Avanzas, Pablo; Alberto San Román, J; Pascual-Figal, Domingo; Teresa, Eduardo de; Crespo-Leiro, Maria G; Manito, Nicolás; Núñez, Julio; Fernández-Avilés, Francisco; Caballero, Ángel; Teis, Albert; Lupón, Josep; Brugada, Ramón; Martín, Carlos; Silva, Jacobo; Revilla-Orodea, Ana; Cánovas, Sergio J; Melero, Jose M; Cuenca-Castillo, Jose J; Gonzalez-Pinto, Angel; Bayes-Genis, Antoni

2017-08-04

Cardiac adipose tissue is a source of progenitor cells with regenerative capacity. Studies in rodents demonstrated that the intramyocardial delivery of cells derived from this tissue improves cardiac function after myocardial infarction (MI). We developed a new reparative approach for damaged myocardium that integrates the regenerative properties of cardiac adipose tissue with tissue engineering. In the adipose graft transposition procedure (AGTP), we dissect a vascularised flap of autologous pericardial adipose tissue and position it over the myocardial scarred area. Following encouraging results in acute and chronic MI porcine models, we performed the clinical trial (NCT01473433, AdiFLAP trial) to evaluate safety in patients with chronic MI undergoing coronary artery bypass graft. The good safety profile and trends in efficacy warranted a larger trial. The AGTP II trial (NCT02798276) is an investigator initiated, prospective, randomised, controlled, multicentre study to assess the efficacy of the AGTP in 108 patients with non-revascularisable MI. Patients will be assigned to standard clinical practice or the AGTP. The primary endpoint is change in necrotic mass ratio by gadolinium enhancement at 91 and 365 days. Secondary endpoints include improvement in regional contractibility by MRI at 91 and 365 days; changes in functional MRI parameters (left ventricular ejection fraction, left and right ventricular geometric remodelling) at 91 and 365 days; levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) at 7, 91 and 365 days; appearance of arrhythmias from 24 hour Holter monitoring at 24 hours, and at 91 and 365 days; all cause death or re-hospitalisation at 365 days; and cardiovascular death or re-hospitalisation at 365 days. The institutional review board approved the trial which will comply with the Declaration of Helsinki. All patients will provide informed consent. It may offer a novel, effective and technically simple technique for patients

A Prospective Programmatic Cost Analysis of Fuel Your Life: A Worksite Translation of DPP.

PubMed

Ingels, Justin B; Walcott, Rebecca L; Wilson, Mark G; Corso, Phaedra S; Padilla, Heather M; Zuercher, Heather; DeJoy, David M; Vandenberg, Robert J

2016-11-01

An accounting of the resources necessary for implementation of efficacious programs is important for economic evaluations and dissemination. A programmatic costs analysis was conducted prospectively in conjunction with an efficacy trial of Fuel Your Life (FYL), a worksite translation of the Diabetes Prevention Program. FYL was implemented through three different modalities, Group, Phone, and Self-study, using a micro-costing approach from both the employer and societal perspectives. The Phone modality was the most costly at $354.6 per participant, compared with $154.6 and $75.5 for the Group and Self-study modalities, respectively. With the inclusion of participant-related costs, the Phone modality was still more expensive than the Group modality but with a smaller incremental difference ($461.4 vs $368.1). This level of cost-related detail for a preventive intervention is rare, and our analysis can aid in the transparency of future economic evaluations.

[Efficacy, safety and comfort of compression therapy models in the immediate post-operative period after a greater saphenectomy. A prospective randomised study].

PubMed

Collazo Chao, Eliseo; Luque, María Antonia; González-Ripoll, Carmen

2010-10-01

There is still controversy on the best compression therapy after performing a greater saphenectomy. The purpose of this study is to establish whether the use of a controlled compression stocking has the same level of safety and efficacy as a compression bandage in the immediate post-operative period after a greater saphenectomy. A prospective, randomised, open-labelled study, comparing three groups: a) a conventional compression bandage for one week, b) a conventional compression bandage replaced by a controlled tubular compression stocking at 5h of its putting in place, c) immediate direct use of the controlled tubular compression stocking, was conducted on fifty-five consecutive outpatients with a greater saphenectomy in one of their legs, and who fulfilled the inclusion criteria. The working hypothesis was that the controlled tubular compression stocking could replace, in terms of efficacy, safety and comfort, the usual controlled compression in the immediate post-operative period after saphenous vein stripping. The analysis variables were pain, control of bleeding, analgesics in the post-operative period, bruising, incapacity during the first week after the operation and comfort level. There were no statistically significant differences found between the three types of compressions studied as regards, safety, efficacy, comfort level, pain and analgesic consumption, but there was as regards the level of convenience in favour of the use of the stocking. The controlled tubular compression stocking can replace the compression bandage with more advantages after greater saphenous vein stripping in outpatients, having the same safety and efficacy. Copyright © 2009 AEC. Published by Elsevier Espana. All rights reserved.

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

PubMed Central

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

2016-01-01

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

Prospective ECG-gated high-pitch dual-source cardiac CT angiography in the diagnosis of congenital cardiovascular abnormalities: Radiation dose and diagnostic efficacy in a pediatric population.

PubMed

Koplay, M; Kizilca, O; Cimen, D; Sivri, M; Erdogan, H; Guvenc, O; Oc, M; Oran, B

2016-11-01

The goal of this study was to investigate the radiation dose and diagnostic efficacy of cardiac computed tomography angiography (CCTA) using prospective ECG-gated high-pitch dual-source computed tomography (DSCT) in the diagnosis of congenital cardiovascular abnormalities in pediatric population. One hundred five pediatric patients who were clinically diagnosed with congenital heart disease with suspected extracardiac vascular abnormalities were included in the study. All CCTAs were performed on a 128×2-section DSCT scanner. CCTA findings were compared with surgical and/or conventional cardiac angiography findings. Dose-length product (DLP) and effective doses (ED) were calculated for each patient. Patients were divided into 4 groups by age, and ED and DLP values were compared among groups. The image quality was evaluated using a five-point scale. CCTA showed 173 abnormalities in 105 patients. There were 2 patients with false positive and 3 with false negative findings. The sensitivity and specificity of CCTA were 98.3% and 99.9%, respectively. The positive predictive value and negative predictive value of CCT were 98.9% and 99.9%, respectively. The average DLP and ED values were 15.6±9.6 (SD) mGy.cm and 0.34±0.10 (SD) mSv, respectively. The mean image quality score was 4.8±0.5 (SD) in all patients. The inter-observer agreement for the image quality scores was good (κ=0.80). CCTA is an excellent imaging modality for evaluation of cardiovascular abnormalities and provides excellent image quality with very low radiation exposure when low-dose prospective ECG-triggered high-pitch DSCT is used. Copyright © 2016 Editions françaises de radiologie. Published by Elsevier Masson SAS. All rights reserved.

Regression Discontinuity in Prospective Evaluations: The Case of the FFVP Evaluation

ERIC Educational Resources Information Center

Klerman, Jacob Alex; Olsho, Lauren E. W.; Bartlett, Susan

2015-01-01

While regression discontinuity has usually been applied retrospectively to secondary data, it is even more attractive when applied prospectively. In a prospective design, data collection can be focused on cases near the discontinuity, thereby improving internal validity and substantially increasing precision. Furthermore, such prospective…

Antral localization worsens the efficacy of enteral stents in malignant digestive tumors.

PubMed

Dolz, Carlos; Vilella, Àngels; González Carro, Pedro; González Huix, Ferran; Espinós, Juan Carlos; Santolaria, Santos; Pérez Roldán, Francisco; Figa, Montserrat; Loras, Carmen; Andreu, Hernán

2011-02-01

Malignant gastric outlet obstruction can be treated by means of enteral stenting or surgical gastrojejunalanatomosis. We evaluated in a prospective and multicentre study the efficacy of the enteral stent on food intake, the quality of life impact, and the relationship between efficacy and determined clinical and technical parameters. Seventy one patients affected by symptoms arising from gastroduodenal obstruction due to malignant tumors, with criteria of irresecability, metastatic disease or very high surgical risk, were treated by means of self expanding metal stents. We used the GOOSS index to evaluate efficacy, and the Euro Qol-5D index to evaluate quality of life. Before stenting patients with GOOSS 0 and 1 were 68 (98.5%). After stenting patients with GOOSS 2 and 3 (semisolid and solid food) were 58 (84,1%) (P<.0001). The Euro Qol-5D index measured before and a month after stenting were 10.17 and 10.04 respectively (P=.6). The median survival was 91 days (9-552). The enteral stents for localised tumors in the duodenum and the gastrojejunalanastomosis were effective in 26 patients (70.2%) and 13 patients respectively (86.6%), while the enteral stents of tumors in the antrum were effective in only 5 patients (29.4%). The palliative treatment of malignant gastric outlet obstruction with a uncovered metal stent produces a significant improvement of oral food intake and maintains the overall quality of life index. The antral localization is associated with a lower efficacy of the procedure. Copyright © 2010 Elsevier España, S.L. All rights reserved.

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.

Prospective nailfold capillaroscopy evaluation of Raynaud's phenomenon in children and adolescents.

PubMed

Piotto, Daniela G P; Hilário, Maria O E; Carvalho, Natalia S; Len, Cláudio A; Andrade, Luis E C; Terreri, Maria T R A

2013-01-01

To evaluate prospectively the clinical features and nailfold capillaroscopy findings of a cohort of children and adolescents who presented Raynaud's phenomenon (RP) without criteria for autoimmune rheumatic diseases. 40 children and adolescents with isolated RP were included. Evidence of systemic autoimmune rheumatic diseases (SARD) was ruled out by thorough clinical and laboratory examination. Concomitantly we also performed wide-field nailfold capillaroscopy evaluation using an optical microscope with magnifications of 10 and 16X. All patients were prospectively re-evaluated within a mean interval time between evaluations of 1.6 years. Thirty (75%) out of 40 patients were female with a mean age of 14.6 years and mean follow-up time of 4.2 years. The mean age of disease onset was 10.4 years and the mean time until diagnosis was 1.4 years. Fourteen out of 40 patients (35%) presented antinuclear antibodies (ANA). Five (12.5%) patients had altered nailfold capillaroscopy at first examination: four presented non-specific microangiopathy and one presented scleroderma pattern. At the re-evaluation three patients (7.5%) presented nailfold capillaroscopy alterations (two SD pattern and one non-specific microangiopathy). The two patients who showed scleroderma pattern at the nailfold capillaroscopy presented along the follow-up a diagnosis of mixed connective tissue disease and hypothyroidism, respectively. One 10 year-old girl with normal nailfold capillaroscopy and presence of autoantibodies (ANA 1/640, nuclear homogeneous pattern, anti-native DNA 1/80) was diagnosed with systemic lupus erythematosus after 1 year of initial evaluation. None of the other children presented diagnosis of SARD along the follow-up. Primary Raynaud´s phenomenon remained the diagnosis in most cases in this series of children and adolescents presenting with initial RP complaint. Nailfold capillaroscopy and determination of autoantibodies were useful ancillary tools in the investigation of

Quantized Step-up Model for Evaluation of Internship in Teaching of Prospective Science Teachers.

ERIC Educational Resources Information Center

Sindhu, R. S.

2002-01-01

Describes the quantized step-up model developed for the evaluation purposes of internship in teaching which is an analogous model of the atomic structure. Assesses prospective teachers' abilities in lesson delivery. (YDS)

The practical evaluation of DNA barcode efficacy.

PubMed

Spouge, John L; Mariño-Ramírez, Leonardo

2012-01-01

This chapter describes a workflow for measuring the efficacy of a barcode in identifying species. First, assemble individual sequence databases corresponding to each barcode marker. A controlled collection of taxonomic data is preferable to GenBank data, because GenBank data can be problematic, particularly when comparing barcodes based on more than one marker. To ensure proper controls when evaluating species identification, specimens not having a sequence in every marker database should be discarded. Second, select a computer algorithm for assigning species to barcode sequences. No algorithm has yet improved notably on assigning a specimen to the species of its nearest neighbor within a barcode database. Because global sequence alignments (e.g., with the Needleman-Wunsch algorithm, or some related algorithm) examine entire barcode sequences, they generally produce better species assignments than local sequence alignments (e.g., with BLAST). No neighboring method (e.g., global sequence similarity, global sequence distance, or evolutionary distance based on a global alignment) has yet shown a notable superiority in identifying species. Finally, "the probability of correct identification" (PCI) provides an appropriate measurement of barcode efficacy. The overall PCI for a data set is the average of the species PCIs, taken over all species in the data set. This chapter states explicitly how to calculate PCI, how to estimate its statistical sampling error, and how to use data on PCR failure to set limits on how much improvements in PCR technology can improve species identification.

Prospective evaluation of a bivalirudin to warfarin transition nomogram.

PubMed

Hohlfelder, Benjamin; Sylvester, Katelyn W; Rimsans, Jessica; DeiCicchi, David; Connors, Jean M

2017-05-01

Bivalirudin may cause a falsely prolonged international normalized ratio (INR) that complicates the discontinuation of bivalirudin when used as a bridge to warfarin. To prospectively validate our novel bivalirudin to warfarin transition nomogram, adult patients who received bivalirudin as a bridge to warfarin between July 2015 and June 2016 were prospectively evaluated, utilizing our predictive nomogram. The major outcome of our analysis was the correlation between the predicted change in INR upon bivalirudin discontinuation based on the nomogram, and the actual change in INR upon bivalirudin discontinuation. The major outcome was analyzed using the Pearson's correlation test. A Pearson's correlation coefficient >0.6 was considered to be a strong correlation. Bivalirudin was used as a bridge to warfarin in 29 patients. The majority of patients (86%) included in the analysis had a ventricular assist device. The median initial bivalirudin rate was 0.07 mg/kg/h and the mean increase in INR when starting bivalirudin was 0.6. The mean final weight-based bivalirudin rate was 0.08 mg/kg/h and the mean change in INR after stopping bivalirudin was 0.7. The Pearson correlation coefficient between the predicted change in INR upon bivalirudin discontinuation and the actual change in INR upon bivalirudin discontinuation was 0.86 (p < 0.001). After bivalirudin discontinuation, 68% of patients had a therapeutic INR. The results of this prospective analysis successfully validated our novel bivalirudin to warfarin transition nomogram. There was a very strong correlation between the predicted change and actual change in INR upon bivalirudin discontinuation.

The efficacy of nasal tip hold-press on venous cannulation pain in children: a prospective randomize controlled study.

PubMed

Maghsoudi, Behzad; Jookar, Mehrdad; Haddad, Hosein; Zoonobi, Zahra; Rakhshan, Mahnaz

2016-12-22

Venipuncture is a common and quiet unpleasant experience for pediatric patients. The pain associated with venous cannulation disturbs the children. Different methods have been used to minimize the pain. The present study evaluated the efficacy of holding and pressing the tip of the nose on the venipuncture pain in pediatric patients. A prospective randomize controlled study carried out using the Visual analogue scale (YAS) for assessment cannulation pain and the Yale preoperative anxiety scale (YPAS) for the assessment of anxiety before cannulation. 60 patients, 6-12 years old, who needed venipuncture for general anesthesia were divided in to two groups of 30 each: the control and the study group. Nasal tip was held and pressed during venipuncture by the parents in the study group. No intervention was done in the control group. The anxiety scale (YPAS) was not different between the two groups before venous cannulation (P = 0.136). Comparing the two groups. There was no different regarding the change in HR and BP during venous cannulation. There was significantly lower cannulation pain in the study in comparison with the control group (P value = 0.010). Holding and pressing the tip of the nose during venipuncture reduce the severity of venipuncture pain in pediatric patients. This could be secondary to distraction along with the physiological effect of the valsalva maneuver on pain. Therefore, we recommend that holding and pressing the tip of the nose is a safe and effective method for reducing the severity of pain from venipuncture in pediatric patients.

The Science Semester: Cross-Disciplinary Inquiry for Prospective Elementary Teachers

NASA Astrophysics Data System (ADS)

Ford, Danielle J.; Fifield, Steve; Madsen, John; Qian, Xiaoyu

2013-10-01

We describe the Science Semester, a semester-long course block that integrates three science courses and a science education methods course for elementary teacher education majors, and examine prospective elementary teachers’ developing conceptions about inquiry, science teaching efficacy, and reflections on learning through inquiry. The Science Semester was designed to provide inquiry-oriented and problem-based learning experiences, opportunities to examine socially relevant issues through cross-disciplinary perspectives, and align with content found in elementary curricula and standards. By the end of the semester, prospective elementary teachers moved from naïve to intermediate understandings of inquiry and significantly increased self-efficacy for science teaching as measured on one subscore of the STEBI-B. Reflecting on the semester, prospective teachers understood and appreciated the goals of the course and the PBL format, but struggled with the open-ended and student-directed elements of the course.

A Prospective Study of the Efficacy, Safety and Pharmacokinetics of Enteral Moxifloxacin in the Treatment of Hemodialysis Patients with Pneumonia.

PubMed

Tokimatsu, Issei; Shigemura, Katsumi; Kotaki, Tomohiro; Yoshikawa, Hiroki; Yamamichi, Fukashi; Tomo, Tadashi; Arakawa, Soichi; Fujisawa, Masato; Kadota, Jun-Ichi

2017-01-01

Objectives To investigate the efficacy of oral moxifloxacin (MFLX) as a treatment for pneumonia in hemodialysis (HD) patients and the pharmacokinetic (PK) profile of MFLX after oral administration. Methods Thirteen adult patients who required HD due to chronic renal failure were enrolled in the present study, which was performed to investigate the treatment of community-acquired pneumonia in HD patients. A standard dose of MFLX (400 mg, once daily) was administered. The therapy was continued, discontinued, or switched to another antibiotic depending on the response of the pneumonia to MFLX. A population PK model was developed using the post-hoc method. Results In total, 13 HD patients with pneumonia (male, n=7; female, n=6) were enrolled in the present study. The evaluation on the 3rd day showed that treatment was successful in 11 patients (84.6%) and that 10 patients were cured (76.9%). In the one case in which MFLX treatment failed, the patient was cured by switching to ceftriaxone (CTRX) (2 g, intravenously) plus levofloxacin (LVFX) (250 mg, orally). The causative bacterium in this male patient was P. aeruginosa. It did not display resistance to fluoroquinolones. One patient had liver dysfunction due to MFLX. The estimated PK parameters of MFLX were as follows: AUC 0→24 , 61.04±17.74 μg h/mL; C max , 5.25±1.12 μg/mL; and C trough , 1.15±0.45 μg/mL. The PK parameters of MFLX among the patients in whom adverse events occurred or in whom a cure was not achieved did not differ from those of the other patients to a statistically significant extent. Conclusion MFLX showed good efficacy and safety in HD patients with community-acquired pneumonia and the results of the PK analysis were favorable. Further prospective studies with larger numbers of patients will be needed to draw definitive conclusions.

Prospective evaluation of CO2 laser-assisted sclerectomy surgery (CLASS) with Mitomycin C.

PubMed

Cutolo, Carlo Alberto; Bagnis, Alessandro; Scotto, Riccardo; Bonzano, Chiara; Traverso, Carlo Enrico

2018-01-01

Our purpose was to evaluate the clinical safety and efficacy of CO 2 laser-assisted sclerectomy surgery (CLASS) with Mitomycin C (MMC) in open angle glaucoma (OAG). This was a prospective, uncontrolled, interventional case series. All subjects underwent CLASS procedure by a single surgeon. After the dissection of a partial thickness scleral flap, topical MMC 0.2 mg/ml was applied to the sclera and the conjunctiva for 3 min. The CO 2 laser with a beam-manipulating system was used to ablate the scleral tissue and expose the Schlemm's canal area. Primary outcomes: intraocular pressure (IOP) change, number of IOP-lowering medicaments change. Adverse events were evaluated as secondary outcomes. Twenty-one eyes of 21 patients underwent the CLASS procedure. Thirteen were primary OAG (62%), two normal pressure glaucoma (10%), three exfoliative glaucoma (14%) and three others secondary OAG. With a mean (SD) follow-up of 15.3 (5.9) months, the IOP changed from 25.4 (6.7) mmHg at baseline to 10.9 (3.4) mmHg al the last visit. Mean reduction of IOP was -14.5 mmHg (95% CI, -17.7 to -11.2, P < 0.001). The median (IQR) number of IOP-lowering medication decreased from 3 (3-3) at baseline to 1 (0-1) at the last visit (P < 0.001). Visual acuity did not change significantly. Adverse events: five eyes (24%) developed iris adhesion to the filtration area that was successfully managed with office-based procedures. In one case (5%), CLASS was converted to trabeculectomy due to intraoperative perforation of the ablated area. There was one case of hypotony maculopathy successfully treated with placement of additional transconjunctival scleral flap sutures. The CLASS procedure with MMC is clinically safe and effective maintaining a large reduction in IOP and in the number of IOP-lowering medications with a mean follow-up of 15 months. Iris adhesion at the filtrating area warrants further evaluation and possibly reflects the surgeon's learning curve.

Evaluation of the relationship between hepatocellular carcinoma location and transarterial chemoembolization efficacy.

PubMed

Miki, Izumi; Murata, Satoru; Uchiyama, Fumio; Yasui, Daisuke; Ueda, Tatsuo; Sugihara, Fumie; Saito, Hidemasa; Yamaguchi, Hidenori; Murakami, Ryusuke; Kawamoto, Chiaki; Uchida, Eiji; Kumita, Shin-Ichiro

2017-09-21

To evaluate the relationship between the location of hepatocellular carcinoma (HCC) and the efficacy of transarterial chemoembolization (TACE). We evaluated 115 patients (127 nodules), excluding recurrent nodules, treated with TACE between January 2011 and June 2014. TACE efficacy was evaluated according to mRECIST. The HCC location coefficient was calculated as the distance from the central portal portion to the HCC center (mm)/liver diameter (mm) on multiplanar reconstruction images rendered (MPR) to visualize bifurcation of the right and left branches of the portal vein and HCC center. The HCC location coefficient was compared between complete response (CR) and non-CR groups in Child-Pugh grade A and B patients. The median location coefficient of HCC among all nodules, the right lobe, and the medial segment was significantly higher in the CR group than in the non-CR group in the Child-Pugh grade A patients (0.82 vs 0.62, P < 0.001; 0.71 vs 0.59, P < 0.01; 0.81 vs 0.49, P < 0.05, respectively). However, there was no significant difference in the median location coefficient of the HCC in the lateral segment between in the CR and in the non-CR groups (0.67 vs 0.65, P > 0.05). On the other hand, in the Child-Pugh grade B patients, the HCC median location coefficient in each lobe and segment was not significantly different between in the CR and in the non-CR groups. Improved TACE efficacy may be obtained for HCC in the peripheral zone of the right lobe and the medial segment in Child-Pugh grade A patients.

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

ERIC Educational Resources Information Center

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

2007-01-01

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

Prospective evaluation of the utility of routine postoperative cystogram after traumatic bladder injury.

PubMed

Inaba, Kenji; Okoye, Obi T; Browder, Timothy; Best, Charles; Branco, Bernardino C; Teixeira, Pedro G; Barmparas, Galinos; Reddy, Sravanthi; Demetriades, Demetrios

2013-12-01

The value of routinely testing bladder repair integrity with a cystogram before urinary catheter removal is unclear. The purpose of this study was to prospectively evaluate the utility of routine postoperative cystogram after traumatic bladder injury. All patients sustaining a bladder injury requiring operative repair at two Level I trauma centers were prospectively enrolled during a 62-month study period ending on January 2011. Injury demographics, imaging data, and outcomes were extracted. All patients were evaluated with either a plain or a computed tomography cystogram. A total of 127 patients were enrolled (mean [SD] age, 30.4 [13.5] years; blunt trauma, 63.8%, mean [SD] Injury Severity Score [ISS], 17.7 [10.6]). A total of 75 patients (59.1%) had an intraperitoneal (IP) bladder injury, 44 (34.6%) had an extraperitoneal (EP) bladder injury, and 8 had a (6.3%) combined IP/EP bladder injury. All patients with IP and IP/EP injuries (n = 83) underwent operative repair and a postoperative cystogram at 8.6 (1.8) days (range, 5-13 days). Sixty-nine IP injuries (83.1%) were simple (dome or body disruption/penetrating injury), while 14 (16.9%) were complex (trigone/requiring ureter implantation). There were no deaths during the follow-up period. With the exception of one patient (1.2%) with a complex injury requiring ureteric implantation, there were no leaks demonstrated on postoperative cystogram, and the urinary catheters were successfully removed. In this prospective evaluation of the role of bladder evaluation after operative repair, routine use of follow-up cystograms for simple injuries did not impact clinical management. For complex repairs to the trigone or those requiring ureter implantation, a follow-up cystogram should be obtained before catheter removal. Diagnostic study, level II.

Efficacy and safety of Privigen(®) in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study).

PubMed

Léger, Jean-Marc; De Bleecker, Jan L; Sommer, Claudia; Robberecht, Wim; Saarela, Mika; Kamienowski, Jerzy; Stelmasiak, Zbigniew; Mielke, Orell; Tackenberg, Björn; Shebl, Amgad; Bauhofer, Artur; Zenker, Othmar; Merkies, Ingemar S J

2013-06-01

This prospective, multicenter, single-arm, open-label Phase III study aimed to evaluate the efficacy and safety of Privigen(®) (10% liquid human intravenous immunoglobulin [IVIG], stabilized with L-proline) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Patients received one induction dose of Privigen (2 g/kg body weight [bw]) and up to seven maintenance doses (1 g/kg bw) at 3-week intervals. The primary efficacy endpoint was the responder rate at completion, defined as improvement of ≥1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The preset success criterion was the responder rate being ≥35%. Of the 31 screened patients, 28 patients were enrolled including 13 (46.4%) IVIG-pretreated patients. The overall responder rate at completion was 60.7% (95% confidence interval [CI]: 42.41%-76.43%). IVIG-pretreated patients demonstrated a higher responder rate than IVIG-naïve patients (76.9% vs. 46.7%). The median (25%-75% quantile) INCAT score improved from 3.5 (3.0-4.5) points at baseline to 2.5 (1.0-3.0) points at completion, as did the mean (standard deviation [SD]) maximum grip strength (66.7 [37.24] kPa vs. 80.9 [31.06] kPa) and the median Medical Research Council sum score (67.0 [61.5-72.0] points vs. 75.5 [71.5-79.5] points). Of 108 adverse events (AEs; 0.417 AEs per infusion), 95 AEs (88.0%) were mild or moderate in intensity and resolved by the end of study. Two serious AEs of hemolysis were reported that resolved after discontinuation of treatment. Thus, Privigen provided efficacious and well-tolerated induction and maintenance treatment in patients with CIDP. © 2013 The Authors. Journal of the Peripheral Nervous System published by Wiley Periodicals, Inc. on behalf of Peripheral Nerve Society.

A prospective programmatic cost analysis of Fuel Your Life: A worksite translation of DPP

PubMed Central

Walcott, Rebecca L; Wilson, Mark G; Corso, Phaedra S; Padilla, Heather; Zuercher, Heather; DeJoy, David M.; Vandenberg, Robert J.

2018-01-01

Objective An accounting of the resources necessary for implementation of efficacious programs is important for economic evaluations and dissemination. Methods A programmatic costs analysis was conducted prospectively in conjunction with an efficacy trial of Fuel Your Life (FYL), a worksite translation of the Diabetes Prevention Program. FYL was implemented through three different modalities, Group, Phone, and Self-study, using a micro-costing approach from both the employer and societal perspectives. Results The Phone modality was the most costly at $354.6 per participant, compared to $154.6 and $75.5 for the Group and Self-study modalities, respectively. With the inclusion of participant-related costs, the Phone modality was still more expensive than the Group modality but with a smaller incremental difference ($461.4 vs. $368.1). Conclusions This level of cost-related detail for a preventive intervention is rare, and our analysis can aid in the transparency of future economic evaluations. PMID:27820760

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…

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…

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

PubMed

Baumhauer, Judith F; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; De Vries, Gwyneth; Le, Ian L D; Nielsen, Dominic; Pedersen, M Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair S E; Daniels, Timothy

2016-05-01

Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were

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.

The efficacy of an educational program for parents of children with epilepsy (FAMOSES): Results of a controlled multicenter evaluation study.

PubMed

Hagemann, Anne; Pfäfflin, Margarete; Nussbeck, Fridtjof W; May, Theodor W

2016-11-01

The objective of this study was to evaluate the efficacy of the educational program FAMOSES (modular service package epilepsy for families) for parents of children with epilepsy. Parents of children with epilepsy from Germany and Austria were included in a controlled prospective multicenter study using a pre-post design. Participants of the FAMOSES program (FAMOSES group, n=148) completed a standardized questionnaire immediately before the program and six months later. The matched control group of parents not participating in the program (n=74, matching ratio 2:1) also answered the questionnaire twice, at an interval of six months. The questionnaire comprised epilepsy-specific outcome measures (e.g., knowledge, coping, fears) and disease-related variables (e.g., seizure frequency). The generalized estimation equation approach was used for statistical analysis. In addition, parents' satisfaction with the FAMOSES program was assessed six months after participation. Parents of the FAMOSES group significantly improved in epilepsy-specific knowledge (group×time interaction: p<.001), coping (p<.01), epilepsy-related fears (p<.05), and in speaking about epilepsy with their child (p<.05) compared with the control group. No effects were found on disease-related variables. Nearly all of the participants rated the FAMOSES parents' program as "very good" (71%) or "good" (27%). The efficacy of the FAMOSES parents' program was confirmed. The results indicate that imparting knowledge and the interactive approach help parents in coping with their child's epilepsy and reduce epilepsy-related fears. Copyright © 2016 Elsevier Inc. All rights reserved.

Conceptual Paradigms and Empirical Investigations for Evaluating INTELSAT's Past Performance and Future Prospects.

ERIC Educational Resources Information Center

Snow, Marcellus S.

This paper summarizes the results of a recent study of the past performance and future prospects of the International Telecommunications Satellite (INTELSAT) Organization. First, an overview of INTELSAT's history is provided and major policy issues are detailed. Five alternative paradigms are then presented through which to evaluate INTELSAT's…

Anesthetic Efficacy of Gow-Gates Nerve Block, Inferior Alveolar Nerve Block, and Their Combination in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Prospective, Randomized Clinical Trial.

PubMed

Saatchi, Masoud; Shafiee, Maryam; Khademi, Abbasali; Memarzadeh, Bahareh

2018-03-01

The purpose of this prospective, randomized clinical trial was to evaluate the anesthetic efficacy of the Gow-Gates nerve block (GGNB), the inferior alveolar nerve block (IANB), and their combination for mandibular molars in patients with symptomatic irreversible pulpitis. One hundred fifty patients diagnosed with symptomatic irreversible pulpitis of a mandibular molar were selected. The patients randomly received 2 GGNB injections, 2 IANB injections, or 1 GGNB injection plus 1 IANB injection of 1.8 mL 2% lidocaine with 1:80,000 epinephrine. Access cavity preparation was initiated 15 minutes after injections. Lip numbness was a requisite for all of the patients. Success was specified as no or mild pain on the basis of Heft-Parker visual analog scale recordings during access cavity preparation or initial instrumentation. Data were analyzed with the chi-square, Kruskal-Wallis, and analysis of variance tests. The success rates of anesthesia were 40%, 44%, and 70% for the GGNB, IANB, and GGNB + IANB groups, respectively. There was no statistically significant difference in the success rate of anesthesia between the GGNB and IANB groups (P > .05). The anesthesia success rate for the GGNB + IANB group was significantly different from those of the GGNB and IANB groups (P < .05). A combination of GGNB and IANB could improve the efficacy of anesthesia in mandibular molars with symptomatic irreversible pulpitis, but it would still require supplemental anesthesia. Further research may be needed to confirm the results of this study. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Results of a multicenter prospective clinical study in Japan for evaluating efficacy and safety of desensitization protocol based on rituximab in ABO-incompatible kidney transplantation.

PubMed

Takahashi, Kota; Saito, Kazuhide; Takahara, Shiro; Fuchinoue, Shohei; Yagisawa, Takashi; Aikawa, Atsushi; Watarai, Yoshihiko; Yoshimura, Norio; Tanabe, Kazunari; Morozumi, Kunio; Shimazu, Motohide

2017-08-01

Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy. Mycophenolate mofetil and low dose steroid were started 28 days pretransplant, followed by two doses of rituximab 375 mg/m 2 at day -14 and day -1, and postoperative immunosuppression with tacrolimus or ciclosporin and basiliximab. The primary endpoint was the non-occurrence rate of acute antibody-mediated rejection. Patient survival and graft survival were monitored for 1 year posttransplant. Eighteen patients received rituximab and underwent ABO-incompatible kidney transplantation. CD19-positive peripheral B cell count decreased rapidly after the first rituximab infusion and recovered gradually after week 36. The desensitization protocol was tolerable, and most rituximab-related infusion reactions were mild. No anti-A/B antibody-mediated rejection occurred with this series. One patient developed anti-HLA antibody-mediated rejection (Banff 07 type II) on day 2, which was successfully managed. Patient and graft survival were both 100 % after 1 year. Our desensitization protocol was confirmed to be clinically effective and with acceptable toxicities for ABO-I-KTx (University Hospital Medical Information Network Registration Number: UMIN000006635).

The efficacy and safety of high-intensity focused ultrasound ablation of benign thyroid nodules.

PubMed

Lang, Brian H; Wu, Arnold L H

2018-04-01

High-intensity focused ultrasound (HIFU) is a promising form of thermal ablation of benign thyroid nodules, but evidence supporting its use is scarce. The present review evaluated the efficacy and safety of single-session HIFU treatment of benign thyroid nodules. As reported in the literature, the extent of nodule shrinkage following treatment ranged from 48.8% to 68.8%. Like other forms of ablation, the shrinkage rate was greatest in the first 3-6 months, and the best responders were patients with small (≤10 mL) nodules. Complications were uncommon, but temporary vocal cord palsy occurred in 3%-4% of patients, and was related to the distance between the HIFU beam and the recurrent laryngeal nerve. Despite being safe and efficacious, a larger-scale prospective trial is required.

A Prospective Randomized Controlled Trial of the Efficacy of External Physical Vibration Lithecbole after Extracorporeal Shock Wave Lithotripsy for a Lower Pole Renal Stone Less Than 2 cm.

PubMed

Long, Qilai; Zhang, Jian; Xu, Zhibing; Zhu, Yanjun; Liu, Li; Wang, Hang; Guo, Jianming; Wang, Guomin

2016-04-01

We evaluate the efficacy and safety of external physical vibration lithecbole in improving the clearance rates of lower pole renal stones after shock wave lithotripsy. A total of 71 patients with lower pole renal stones (6 to 20 mm) were prospectively randomized into 2 groups. In the treatment group 34 patients were treated with external physical vibration lithecbole after shock wave lithotripsy. In the control group 37 patients underwent shock wave lithotripsy only. External physical vibration lithecbole was performed without anesthesia by the same team using the Friend-I External Physical Vibration Lithecbole (Fu Jian Da Medical Instrument Co., Ltd, Zhengzhou, China). The stone-free rate, stone expulsion rate, stone expulsion time and incidence of complications were monitored. External physical vibration lithecbole was successful in assisting the discharge of stone fragments. The stone-free status was 76.5% in the treatment group and 48.6% in the control group (p=0.008). Stone expulsion rates at day 1, week 1 and week 3 were 76.5% (26), 94.1% (32) and 94.1% (32) in the treatment group vs 43.2% (16), 73.0% (27) and 89.2% (33) in the control group, respectively. Mean stone fragment expulsion time was 11.2 minutes in the treatment group and 9.17 hours in the control group (p=0.016). There was no significant difference in complications between the 2 groups (p >0.05). External physical vibration lithecbole was efficacious in assisting the discharge of lower pole renal stone fragments and can be used as an adjunctive method of minimally invasive stone treatment. However, additional investigations are needed to confirm the efficacy. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Efficacy and safety of Vitex agnus-castus extract for treatment of premenstrual syndrome in Japanese patients: a prospective, open-label study.

PubMed

Momoeda, Mikio; Sasaki, Hidetaka; Tagashira, Eiko; Ogishima, Masayuki; Takano, Yuichi; Ochiai, Kazunori

2014-03-01

Herbal medicine containing Vitex agnus-castus (VAC) extract is widely used by women with premenstrual syndrome (PMS) in Europe, however, in Japan, clinical evidence remains to be determined. This study attempted to investigate the efficacy and safety profiles of VAC extract in Japanese patients with PMS. A multi-center, prospective, open-label, single-arm, phase 3 study was performed in Japanese women with PMS and aged 18-44 years. The patients received Prefemin® (Max Zeller Söhne AG, Romanshorn, Switzerland), containing 20 mg of VAC extract, once daily for three menstrual cycles. The efficacy profile was examined based on the intensity of ten PMS symptoms-irritability, depressed mood, anger, headache, bloating, breast fullness, skin disorder, fatigue, drowsiness, and sleeplessness-recorded by patients via a visual analog scale (VAS). In addition, the responder rate was calculated based on the total VAS score defined by the sum of the VAS scores of the first six symptoms mentioned above. Furthermore, physician's global assessment (PGA) scores were recorded. Adverse events including vital signs and laboratory test values were monitored as safety evaluation. Sixty-nine patients received Prefemin®. After the first menstrual cycle, a statistically significant decrease in total VAS score was observed (P<0.001), and the score continued to diminish for the following two cycles. Each of the ten symptom scores decreased significantly in this manner. In addition, the responder rate increased in a time-dependent manner; the rate at the third menstrual cycle was 91.0%, and almost all of the patients were without symptoms or exhibited only mild symptoms based on PGA. Eight patients exhibited non-serious adverse events, one of which was allergic dermatitis whose causal relationship with VAC was not ruled out. VAC extract improved PMS symptoms in Japanese patients, with no substantial adverse events. This is the first study to report the effect of VAC extract in Japanese

The HIV Medication Taking Self-Efficacy Scale: Psychometric Evaluation

PubMed Central

Erlen, Judith A.; Cha, EunSeok; Kim, Kevin H.; Caruthers, Donna; Sereika, Susan M.

2010-01-01

Aim This paper is a report of an examination of the psychometric properties of the HIV Medication Taking Self-efficacy Scale. Background Self-efficacy is a critically important component of strategies to improve HIV medication-taking; however, valid and reliable tools for assessing HIV medication-taking self-efficacy are limited. Method We used a cross-sectional, correlational design. Between 2003 and 2007, 326 participants were recruited from sites in Pennsylvania and Ohio in the United States of America. Six self-report questionnaires administered at baseline and 12 weeks later during “Improving Adherence to Antiretroviral Therapy” were used to examine the variables of interest. Means and variances, reliability, criterion, and construct validity of the HIV Medication Taking Self-efficacy Scale were assessed. Findings Participants reported high self-confidence in their ability to carry out specific medication-related tasks (mean=8.31) and in the medication’s ability to effect good outcomes (mean=8.56). The HIV Medication Taking Self-efficacy Scale and subscales showed excellent reliability (α = .93 ~ .94). Criterion validity was well-established by examining the relationships between the HIV Medication Taking Self-efficacy Scale and selected physiological and psychological factors, and self-reported medication adherence (r = −.20 ~ .58). A two-factor model with a correlation between self-efficacy belief and outcome expectancy fitted the data well (model χ2 = 3871.95, df = 325, p<001; CFA =.96; RMSEA =.046). Conclusion The HIV Medication Taking Self-efficacy Scale is a psychometrically sound measure of medication-taking self-efficacy for use by researchers and clinicians with people with HIV. The findings offer insight into the development of interventions to promote self-efficacy and medication adherence in persons with HIV. PMID:20722799

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

PubMed

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

2014-08-11

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

Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes.

PubMed

Ferro, Matteo; Bottero, Danilo; D'Elia, Carolina; Matei, Deliu Victor; Cioffi, Antonio; Cozzi, Gabriele; Serino, Alessandro; Cordima, Giovanni; Bianchi, Roberto; Incarbone, Piero Giacomo; Brescia, Antonio; Musi, Gennaro; Fusco, Ferdinando; Detti, Serena; Mirone, Vincenzo; de Cobelli, Ottavio

2017-03-01

To evaluate the efficacy and safety of the Virtue ® male sling (Coloplast, Humlebaek, Denmark) in a cohort of patients affected by post-prostatectomy stress urinary incontinence (SUI). All 29 consecutive patients treated with a Virtue male sling at our Institution between July 2012 and October 2013 were included in the present prospective, non-randomized study. Patients were evaluated preoperatively and at 1, 3, 6, 12, 24 and 36 months after surgery using a 24-h pad weight test, the International Consultation on Incontinence short-form questionnaire (ICIQ-SF), Urinary Symptom Profile (USP) questionnaire, a bladder diary, uroflowmetry and the Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity questionnaires. The mean patient age was 65.5 years. A total of 72.4% of patients had preoperative mild incontinence (1-2 pads/day), while nine patients used 3-5 pads/day. There were a total of 17 complications, which occurred in 29 patients (58.6%); all were Clavien-Dindo grade I. At 12-month follow-up patients showed a significant improvement in 24-h pad test (128.6 vs 2.5 g), number of pads per day (2 vs 0), ICIQ-SF score (14.3 vs 0.9) and USP score for SUI (4 vs 0), and outcomes remained stable at 36 months. At last follow-up, the median score on the PGI-I questionnaire was 1 (very much better). The Virtue male sling is an effective treatment option for low to moderate post-prostatectomy incontinence. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Efficacy and tolerability of bromelain in patients with chronic rhinosinusitis--a pilot study.

PubMed

Büttner, L; Achilles, N; Böhm, M; Shah-Hosseini, K; Mösges, R

2013-01-01

To evaluate the efficacy, tolerability, and impact on quality of life (QoL) of bromelain tablets (500 FIP) in patients with chronic rhinosinusitis (CRS). In this prospective, open-label observational pilot study, 12 patients suffering from CRS with (CRS+NP) or without (CRS-NP) nasal polyps who had undergone prior sinus surgery were treated with bromelain tablets (500 FIP) for three months. Efficacy was evaluated using symptom scores (Total Symptom Scores: TSS); a Total Rhinoscopy Score (TRS) was also determined. QoL was assessed by using the German, adapted version of the Sinonasal Outcome Test 20 (SNOT-20 GAV). Treatment with bromelain tablets (500 FIP) improved TSS, TRS and SNOT-20 GAV on average. This treatment was found to be more effective, however, for CRS-NP than for CRS+NP. The average intake was six tablets, equivalent to a daily dosage of 3000 FIP. No adverse events were observed. Preliminary results indicate good tolerability, symptom control, and improvement in QoL for the treatment of CRS using bromelain tablets (500 FIP).

Impact of Adolescents' Filial Self-Efficacy on Quality of Family Functioning and Satisfaction

ERIC Educational Resources Information Center

Caprara, Gian Vittorio; Pastorelli, Concetta; Regalia, Camillo; Scabini, Eugenia; Bandura, Albert

2005-01-01

In this prospective study, we tested a structural model in which adolescents' perceived self-efficacy to manage parental relationships affected their satisfaction with family life both directly, and indirectly, through its impact on family practices. Findings based on 380 Italian adolescents showed that perceived filial self-efficacy was linked…

Evaluation of early efficacy endpoints for proof-of-concept trials.

PubMed

Chen, Cong; Sun, Linda; Li, Chih-Lin

2013-03-11

A Phase II proof-of-concept (POC) trial usually uses an early efficacy endpoint other than a clinical endpoint as the primary endpoint. Because of the advancement in bioscience and technology, which has yielded a number of new surrogate biomarkers, drug developers often have more candidate endpoints to choose from than they can handle. As a result, selection of endpoint and its effect size as well as choice of type I/II error rates are often at the center of heated debates in design of POC trials. While optimization of the trade-off between benefit and cost is the implicit objective in such a decision-making process, it is seldom explicitly accounted for in practice. In this research note, motivated by real examples from the oncology field, we provide practical measures for evaluation of early efficacy endpoints (E4) for POC trials. We further provide optimal design strategies for POC trials that include optimal Go-No Go decision criteria for initiation of Phase III and optimal resource allocation strategies for conducting multiple POC trials in a portfolio under fixed resources. Although oncology is used for illustration purpose, the same idea developed in this research note also applies to similar situations in other therapeutic areas or in early-stage drug development in that a Go-No Go decision has to rely on limited data from an early efficacy endpoint and cost-effectiveness is the main concern.

Developing Essay Writing Skills: An Evaluation of the Modelling Behaviour Method and the Influence of Student Self-Efficacy

ERIC Educational Resources Information Center

Callinan, Carol J.; van der Zee, Emile; Wilson, Garry

2018-01-01

Social cognitive learning theory has shown that observational learning positively influences essay writing development in high-school students, and that self-efficacy impacts on motivation. This study investigated the relative contribution of model observation, model evaluation, post-submission feedback, and factors relating to self-efficacy, as…

Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

PubMed

Favilla, V; Russo, G I; Zucchi, A; Siracusa, G; Privitera, S; Cimino, S; Madonia, M; Cai, T; Cavallini, G; Liguori, G; D'Achille, G; Silvani, M; Franco, G; Verze, P; Palmieri, A; Torrisi, B; Mirone, V; Morgia, G

2017-07-01

Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I. © 2017 American Society of Andrology and

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.

A Longitudinal Study on Mathematics Teaching Efficacy: Which Factors (Un)Support the Development?

ERIC Educational Resources Information Center

Isiksal-Bostan, Mine

2016-01-01

The aim of this longitudinal study was to examine prospective teachers' mathematics teaching efficacy belief during their enrollment in teacher education program and at the end of their first year of teaching. In addition, the factors that enhance or inhibit participants' efficacy belief and how these factors affect their mathematics teaching…

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…

Long-term prospective evaluation of an inpatient voiding reeducation program for lower urinary tract conditions in children.

PubMed

Golli, Tanja; Meglič, Anamarija; Kenda, Rajko B

2013-04-01

Our aim was to evaluate the efficacy of our treatment program for children with lower urinary tract conditions, developed at the Department of Pediatric Nephrology of the University Children's Hospital in Ljubljana. Sixty-four patients with lower urinary tract conditions were randomly allocated to two groups. Group A received treatment immediately, whereas patients of group B received no treatment for a period of 3 months-the amount of time it takes to complete our program. No child in group B experienced spontaneous regression of their symptoms in the 3-month delay period, while the patients of group A were already being treated and were achieving results. Thus, all the patients of group B then entered the program in exactly the same way as patients of group A. The final success rate in both groups did not differ significantly (p = 0.706-1.000) and ranged from 86.2 % for group A and 86.7 to 90 % for group B. Long-term follow-up showed statistically identical success rates (p = 1.000). This prospective controlled study with long-term follow-up (48 months) shows that our treatment program, applied as an inpatient voiding school program, is an effective method, with durable results.

Exploring Prospective EFL Teachers' Perceived Self-Efficacy and Beliefs on English Language Learning

ERIC Educational Resources Information Center

Genç, Gülten; Kulusakli, Emine; Aydin, Savas

2016-01-01

Learners' perceived self-efficacy and beliefs on English language learning are important in education. Taking into consideration the important impact of individual variables on language learning, this study seeks to highlight the relationship between Turkish EFL learners' beliefs about language learning and their sense of self-efficacy. The…

[Evaluation of NAAGA efficacy in dry eye syndrome].

PubMed

Brignole-Baudouin, F; Robert, P-Y; Creuzot-Garcher, C; Olmiere, C; Delval, L; Baudouin, C

2009-11-01

The aim of this study was to assess the efficacy of Naabak((R)) eyedrops in reducing inflammation in dry eye syndrome. This pilot, multicenter, randomized, double-blind, parallel study was carried out in adult patients suffering from moderate dry eye syndrome. Patients were treated for three months with preservative-free NAAGA (Naabak((R))) or with sodium chloride 0.9% without preservative (Larmabak(R)). They received the treatment four to six times a day during the 1(st) month and three to four times a day during the 2(nd) and 3(rd) months. At each visit (D28 and D84), clinical tests were performed as well as a biological evaluation of HLA-DR and MUC5AC expression on conjunctival imprints using flow cytometry. After three months of treatment, the ocular surface symptoms and overall discomfort were improved in patients treated with Naabak(R) and in those treated with Larmabak(R) with no significant difference between the groups. Cytological impression showed a significant decrease in the expression of inflammatory markers, notably antigen HLA-DR, in the Naabak(R) group. This study confirms the anti-inflammatory property of preservative-free NAAGA (Naabak(R)) in the context of dry eye syndrome with a similar clinical efficacy compared to sodium chloride solution (Larmabak(R)). Naabak(R) could present an additional advantage compared to artificial tears and could be indicated in the treatment of moderate inflammatory dry eye syndrome.

Self-efficacy beliefs as shapers of children's aspirations and career trajectories.

PubMed

Bandura, A; Barbaranelli, C; Caprara, G V; Pastorelli, C

2001-01-01

This prospective study tested with 272 children a structural model of the network of sociocognitive influences that shape children's career aspirations and trajectories. Familial socioeconomic status is linked to children's career trajectories only indirectly through its effects on parents' perceived efficacy and academic aspirations. The impact of parental self-efficacy and aspirations on their children's perceived career efficacy and choice is, in turn, entirely mediated through the children's perceived efficacy and academic aspirations. Children's perceived academic, social, and self-regulatory efficacy influence the types of occupational activities for which they judge themselves to be efficacious both directly and through their impact on academic aspirations. Perceived occupational self-efficacy gives direction to the kinds of career pursuits children seriously consider for their life's work and those they disfavor. Children's perceived efficacy rather than their actual academic achievement is the key determinant of their perceived occupational self-efficacy and preferred choice of worklife. Analyses of gender differences reveal that perceived occupational self-efficacy predicts traditionality of career choice.

Safety and Efficacy of Cryoballoon Ablation for Paroxysmal Atrial Fibrillation in Japan　- Results From the Japanese Prospective Post-Market Surveillance Study.

PubMed

Okumura, Ken; Matsumoto, Kazuo; Kobayashi, Yoshinori; Nogami, Akihiko; Hokanson, Robert B; Kueffer, Fred

2016-07-25

Outcomes of cryoballoon ablation for paroxysmal atrial fibrillation (PAF) have been reported in the Western countries but not in Japan. The CRYO-Japan PMS study was a single-arm, observational, multicenter, prospective study of the 2nd-generation cryoballoon Arctic Front Advance(TM). We evaluated device- and procedure-related complications and clinical outcomes at 6 months. The 616 patients (male, 72%; mean age, 63±11 years) were enrolled from 33 Japanese hospitals. Of all patients, 610 had PAF, and procedural data were analyzed in 607. A subset of 328 patients was followed for 6 months for the primary efficacy analysis. AF recurrence outside the 3-month blanking period or repeat ablation was considered treatment failure. Pulmonary vein isolation was achieved in 606/607 patients (99.8%); 1 patient (0.3%) had a repeat ablation during the blanking period. Freedom from AF at 6 months was 88.4% (95% CI: 84.1-91.6%). Device- and/or procedure-related adverse events included phrenic nerve injury unresolved at hospital discharge in 9/616 patients (1.5%), which resolved within 6 months in 7, pericardial effusion in 5/616 (0.8%), and tamponade in 4/616 (0.6%). One non-device-related death from pneumonia was reported 6 days post-procedure. Cryoballoon ablation is safe and effective for Japanese PAF patients, with 88.4% AF freedom at 6 months post-ablation. (Circ J 2016; 80: 1744-1749).

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…

A randomized, blinded, prospective trial to compare the safety and efficacy of three bowel-cleansing solutions for colonoscopy (HSG-01*).

PubMed

Ell, C; Fischbach, W; Keller, R; Dehe, M; Mayer, G; Schneider, B; Albrecht, U; Schuette, W

2003-04-01

There are conflicting data regarding the optimal bowel preparation for colonoscopy. This study was carried out to compare the efficacy, safety, and tolerability of three widely used bowel lavage solutions: the standard polyethylene glycol-electrolyte solution based on the GoLytely formulation (PEG-EL1; Klean-Prep); a sulphate-free PEG-EL solution based on the NuLytely formulation (PEG-EL2, Endofalk); and a sodium phosphate preparation (NaP, Fleet Phospho-Soda). A total of 185 consecutive patients scheduled for elective colonoscopy were prospectively randomly assigned to undergo pre-colonoscopic bowel cleansing with either 4 l of PEG-EL1 (n=64), 3 l of PEG-EL2 (n=59), or 90 ml of NaP (n=62). The quality of preparatory colonic cleansing for each segment from the rectum to the ascending colon was scored on a five-level rating scale (1, very good to 5, very poor) by endoscopists who were blinded with regard to the type of preparation used. The primary outcome measure for the comparison of treatments was the "worst" score in any of the rated bowel segments. Safety and tolerability were evaluated by means of a symptom questionnaire completed by each patient immediately before the procedure. Of the 185 patients who were randomly assigned to one of the three treatments, 175 underwent colonoscopy and 173 were evaluable with regard to efficacy - 59, 54, and 60 patients treated with PEG-EL1, PEG-EL2, and NaP, respectively. The treatment groups were comparable with regard to the baseline characteristics. PEG-EL1 was statistically significantly superior to the other treatments in relation to the "worst cleansing" score ( P

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

Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis.

PubMed

Huang, Xiaoquan; Chen, Shiyao; Zhao, Hetong; Zeng, Xiaoqing; Lian, Jingjing; Tseng, Yujen; Chen, Jie

2017-03-01

The efficacy of transoral incisionless fundoplication (TIF) performed with the EsophyX device (Redmond, Washington, USA) and its long-term outcomes in gastresophageal reflux disease (GERD) are debated. We, therefore, performed a systematic review with meta-analysis of studies evaluating the role of TIF in GERD. A systematic search of EMBASE, SCOPUS, PubMed, and the Cochrane Library Central was performed. All original studies reporting outcomes in GERD patients who underwent TIF were identified. Only randomized controlled trials (RCTs) evaluating the efficacy of TIF, and prospective observational studies reporting outcomes after TIF were included. A total of 18 studies (963 patients) published between 2007 and 2015 were identified, including five RCTs and 13 prospective observational studies. The pooled relative risk of response rate to TIF versus PPIs/sham was 2.44 (95 % CI 1.25-4.79, p = 0.0009) in RCTs in the intention-to-treat analysis. The total number of refluxes was reduced after TIF compared with the PPIs/sham group. The esophageal acid exposure time and acid reflux episodes after TIF were not significantly improved. Proton-pump inhibitors (PPIs) usage increased with time and most of the patients resumed PPIs treatment at reduced dosage during the long-term follow-up. The total satisfaction rate after TIF was about 69.15 % in 6 months. The incidence of severe adverse events consisting of gastrointestinal perforation and bleeding was 2.4 %. TIF is an alternative intervention in controlling GERD-related symptoms with comparable short-term patient satisfaction. Long-term results showed decreased efficacy with time. Patients often resume PPIs at reduced doses in the near future.

Efficacy and safety of ceftazidime-avibactam versus imipenem-cilastatin in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults: results of a prospective, investigator-blinded, randomized study.

PubMed

Vazquez, José A; González Patzán, Luis Demetrio; Stricklin, David; Duttaroy, Dipesh D; Kreidly, Zouheir; Lipka, Joy; Sable, Carole

2012-12-01

The aim of this prospective phase II, randomized, investigator-blinded study (NCT00690378) was to compare the efficacy and safety of ceftazidime-avibactam and imipenem-cilastatin in hospitalized adults with serious complicated urinary tract infection (cUTI) due to Gram-negative pathogens. Patients aged between 18 and 90 years with cUTI were enrolled and stratified by infection type (acute pyelonephritis or other cUTI) and randomized 1:1 to receive intravenous ceftazidime 500 mg plus avibactam 125 mg every 8 hours or imipenem-cilastatin 500 mg every 6 hours. Patients meeting pre-specified improvement criteria after 4 days could be switched to oral ciprofloxacin. Patients were treated for a total of 7-14 days. The primary efficacy objective was a favorable microbiological response at the test-of-cure (TOC) visit 5-9 days post-therapy in microbiologically evaluable (ME) patients. Overall, 135 patients received study therapy (safety population); 62 were included in the ME population (ceftazidime-avibactam, n = 27; imipenem-cilastatin, n = 35). The predominant uropathogen was Escherichia coli. Favorable microbiological response was achieved in 70.4% of ME patients receiving ceftazidime-avibactam and 71.4% receiving imipenem-cilastatin at the TOC visit (observed difference -1.1% [95% CI: -27.2%, 25.0%]). Among ME patients with ceftazidime-resistant uropathogens, response was observed in 6/7 (85.7%) receiving ceftazidime-avibactam. Adverse events were observed in 67.6% and 76.1% of patients receiving ceftazidime-avibactam and imipenem-cilastatin, respectively. Limitations of the study include the small number of patients in the ME population. The results suggest that the efficacy and safety of ceftazidime-avibactam may be similar to that of imipenem-cilastatin.

Coping efficacy and psychological problems of children of divorce.

PubMed

Sandler, I N; Tein, J Y; Mehta, P; Wolchik, S; Ayers, T

2000-01-01

Three models of the relations of coping efficacy, coping, and psychological problems of children of divorce were investigated. A structural equation model using cross-sectional data of 356 nine- to twelve-year-old children of divorce yielded results that supported coping efficacy as a mediator of the relations between both active coping and avoiding coping and psychological problems. In a prospective longitudinal model with a subsample of 162 of these children, support was found for Time 2 coping efficacy as a mediator of the relations between Time 1 active coping and Time 2 internalizing of problems. Individual growth curve models over four waves also found support for coping efficacy as a mediator of the relations between active coping and psychological problems. No support was found for alternative models of coping as a mediator of the relations between efficacy and symptoms or for coping efficacy as a moderator of the relations between coping and symptoms.

[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.

Self-Efficacy Perceptions of Prospective Social Studies Teachers in Relation to History Teaching

ERIC Educational Resources Information Center

Yilmaz, Ali

2009-01-01

Self-efficacy is one of the important concepts of the social cognitive theory, and can be defined as individual's perception of his or her own capabilities for organizing and successfully executing the courses of action required to attain designated types of performance. Teachers with high self-efficacy perception can contribute to creation of a…

Evaluation of physiotherapy in a prospective cohort of early axial spondyloarthritis. Data from the DESIR cohort.

PubMed

Escalas, Cécile; Dalichampt, Marie; Dougados, Maxime; Poiraudeau, Serge

2016-03-01

To evaluate the effect of physiotherapy on functional limitation in an observational cohort of early axial spondyloarthritis. prospective population-based cohort study. 708 patients with early axial spondyloarthritis between 2007 and 2010 naive of TNF blockers. early physiotherapy defined by at least eight supervised sessions of physical therapy during the first six months. the primary outcome was functional improvement defined by a relative improvement of at least 20% in BASFI at six months. Secondary outcomes were improvement in BASFI at one and two years and ASAS20 response criteria at six months. a propensity score of having physiotherapy was developed and multivariate analysis using propensity score weighting were used to assess the effect of physiotherapy on outcome. Overall, 166 (24%) patients had physiotherapy during the first six months. After using propensity score weighting, there was no functional improvement on the primary outcome in patients treated with early physical therapy (relative risk [IC95%]: 1.15 [0.91-1.45]). No differences were observed on secondary outcomes (relative risk [IC95%]: 0.94 [0.80-1.11]). It seems there is no functional benefit for patients with early spondyloarthritis to be treated early by physiotherapy in daily practice, even though the efficacy of physiotherapy has been shown in several randomized controlled studies. Copyright © 2015 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Efficacy of evaluation of rooster sperm morphology using different staining methods.

PubMed

Lukaszewicz, E; Jerysz, A; Partyka, A; Siudzińska, A

2008-12-01

This work focused on inexpensive methods of evaluation fowl sperm morphology, based on eosin-nigrosin smears, which can determine disorders in spermatogenesis and can be recommended for evaluating the fertilising potency and selecting males in flocks reproduced by artificial insemination. Four fowl breeds (Black Minorca, Italian Partridge, Forwerk and Greenleg Partridge) were used to determine the efficacy of sperm morphology evaluation using four eosin-nigrosin staining methods (according to Blom, Bakst and Cecil, Morisson, Jaśkowski) and three examiners of different experience (high, medium, novice). There were significant (P< or = 0.01) differences in sperm morphology between Blom's staining method and those of Bakst and Cecil, Morisson or Jaśkowski, irrespective of fowl breed and examiners experience. Blom stain caused sperm head swelling and showed a drastic reduction in the proportion of live spermatozoa with normal morphology. The staining method had a greater influence on sperm morphology evaluation than the experience of the examiners.

Efficacy of pulsed dye laser treatment for common warts is not influenced by the causative HPV type: a prospective study.

PubMed

Fichman, Yoseph; Levi, Assi; Hodak, Emmilia; Halachmi, Shlomit; Mazor, Sigal; Wolf, Dana; Caplan, Orit; Lapidoth, Moshe

2018-05-01

Verruca vulgaris (VV) is a prevalent skin condition caused by various subtypes of human papilloma virus (HPV). The most common causes of non-genital lesions are HPV types 2 and 4, and to a lesser extent types 1, 3, 26, 29, and 57. Although numerous therapeutic modalities exist, none is universally effective or without adverse events (AE). Pulsed dye laser (PDL) is a favorable option due to its observed efficacy and relatively low AE rate. However, it is not known which verrucae are most likely to respond to PDL, or whether the causative viral subtype influences this response. The objective of this prospective blinded study was to assess whether the HPV subtype was predictive of response to PDL. For that matter, 26 verrucae from 26 immunocompetent patients were biopsied prior to treatment by PDL. HPV coding sequences were isolated and genotyped using PCR analysis. Patients were treated by PDL (595 nm wavelength, 5 mm spot size, 1.5 ms pulse duration, 12 J/cm 2 fluence) once a month for up to 6 months, and clinical response was assessed. Binary logistic regression analysis and linear logistic regression analysis were used in order to evaluate statistical significance. Different types of HPV were identified in 22 of 26 tissue samples. Response to treatment did not correlate with HPV type, age, or gender. As no association between HPV type and response to PDL therapy could be established, it is therefore equally effective for all HPV types and remains a favorable treatment option for all VV.

Multicenter prospective evaluation of a new articulating 5-mm endoscopic linear stapler.

PubMed

Kuthe, Andreas; Haemmerle, Alexander; Ludwig, Kaja; Falck, Stephan; Hiller, Wolfgang; Mainik, Frederick; Freys, Stephan; Dubovoy, Lev; Jaehne, Joachim; Oldhafer, Karl

2016-05-01

The objective of this study was to evaluate the safety and efficacy of a novel 5-mm laparoscopic linear stapler in clinical gastrointestinal surgical applications. A prospective, single-arm study with an open enrollment of subjects requiring stapling of the gastrointestinal (GI) tract was performed. The study endpoints were the number of complications and technical failures associated with the use of a novel stapler when compared to similar events with conventional staplers as described in the medical literature. Seven centers enrolled 160 subjects, 150 of which were followed up to at least 30 days postoperatively. Intraoperative success: In 423 deployments, there were two staple line leaks and five staple line bleeds, all of which were intraoperatively resolved. In addition, incomplete staple lines were noted as a result of user error (n = 15) or device-related issues (n = 22), all of which were immediately resolved and none of which resulted in a complication or a change of the surgical procedure. Late outcomes: A total of 13 surgical complications in 160 patients were related to a GI transection or anastomosis, 12 of which related to a hand-sewn anastomosis or use of other commercially available staplers. One event (1/153, 0.065 %) on POD 1, involving bleeding of the staple line, was felt to be related to the use of the new stapler. The study confirmed that the new device was user-friendly (9 % incidence of problems firing the device), reliable (3 % device failures) and safe (<1 % complication rate related to the stapler). Based on these results, it would seem that this new 5-mm stapler is a safe and effective alternative to standard 12-mm staplers.

Teachers' Source Evaluation Self-Efficacy Predicts Their Use of Relevant Source Features When Evaluating the Trustworthiness of Web Sources on Special Education

ERIC Educational Resources Information Center

Andreassen, Rune; Bråten, Ivar

2013-01-01

Building on prior research and theory concerning source evaluation and the role of self-efficacy in the context of online learning, this study investigated the relationship between teachers' beliefs about their capability to evaluate the trustworthiness of sources and their reliance on relevant source features when judging the trustworthiness…

Retrospective evaluation of the efficacy of isolating bacteria from synovial fluid in dogs with suspected septic arthritis.

PubMed

Scharf, V F; Lewis, S T; Wellehan, J F; Wamsley, H L; Richardson, R; Sundstrom, D A; Lewis, D D

2015-06-01

To evaluate the efficacy of synovial fluid culture in obtaining the causative organism from dogs with suspected septic arthritis. In this retrospective evaluation, synovial fluid cytology and microbiology submissions from dogs with suspected septic arthritis from March 2007 to August 2011 were reviewed. Synovial fluid cytology consistent with joint sepsis was identified. Cultures of synovial fluid from dogs with clinical histories and abnormalities consistent with septic arthritis were used to evaluate the efficacy of bacterial isolation. In total, 36 dogs met the inclusion criteria. Initial aerobic cultures of joint fluid yielded bacterial growth in 44% of these dogs. All anaerobic cultures were negative. In 19% of the dogs with positive cultures, antibiotics had been administered prior to arthrocentesis compared with 10% of dogs with negative cultures. There was no association between culture efficacy and the administration of antimicrobial treatment prior to synovial fluid culture or recent surgery involving the affected joint (P=0.637 and P=0.106, respectively). Culture of synovial fluid from dogs with suspected septic arthritis has a low yield, necessitating a more effective means of identifying bacteria from suspected septic joints in dogs. © 2015 Australian Veterinary Association.

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…

Evaluation of Efficacy and Safety of Longterm Feeding with Amino Acid-Based Formula in Infants with Cow’s Milk Protein Allergy: Results of the Open-Label Prospective Controlled Post-Registration Trial.

PubMed

Novik, G A; Khaleva, E G; Bychkova, N V; Zdanova, M V

The cow’s milk allergy (CMA) prevalence is 2−3% in children under one year. Approximately in 5% of cases transferring to extensively hydrolysed formula (eHF) doesn’t lead to disappearance of CMA symptoms. Evaluation of efficacy and safety of amino-acid formula (AAF) longterm feeding in children under one year and development of predictors of successful transfer from AAF to eHF. In open-label prospective post-registration trial duration of 365 days were included 43 children aged from 3 to 12 months with CMA. CMA was based on Russian and international guidelines. When a patient was included in the trial, child received eHF for 4 weeks with the evaluation of the effect of elimination diet (ED): in case of absence of effect, for diagnostic purposes child feed with AAF for 2 weeks and upon receiving the effect, child continued to receive it for at least 6 months. Diet was considered effective if there were observed disappearance of clinical manifestations of CMA during of formula using. Children fed with AAF gain weight and increased height statistically higher during the first 6 months, compared with children receiving eHF, but without subsequent difference in a year. After 4 weeks’ of AAF feeding, there was a significant decrease in SCORAD index from 46.84 (SD 4.164) to 2.52 (SD 2.204) (p=0.005); disappearance of gastrointestinal manifestations of CMA from 3 to 14 day. After 4 weeks, the 100% normalization of previously elevated faecal calprotectin (p<0.05) was observed; and after 6months. ED, in 60% of children normalization of the index of activation of basophils with milk was observed. 38.7% of children were transferred to eHF in 6 months, 12.9% and 25.8% in 9 and 12 months respectively. Use of AAF for children with CMA is an effective and safe treatment without lengthening the period of elimination, which is necessary for the formation of tolerance to cow’s milk protein and has a positive impact on weight and height. Normalization of specific activation

Do medical students and young physicians assess reliably their self-efficacy regarding communication skills? A prospective study from end of medical school until end of internship.

PubMed

Gude, Tore; Finset, Arnstein; Anvik, Tor; Bærheim, Anders; Fasmer, Ole Bernt; Grimstad, Hilde; Vaglum, Per

2017-06-30

This prospective study from end of medical school through internship investigates the course and possible change of self- reported self-efficacy in communication skills compared with observers' ratings of such skills in consultations with simulated patients. Sixty-two medical students (43 females) from four Norwegian universities performed a videotaped consultation with a simulated patient immediately before medical school graduation (T1) and after internship (internal medicine, surgery and family medicine, half a year each - T2). Before each consultation, the participants assessed their general self-efficacy in communication skills. Trained observers scored the videos and applied a well-validated instrument to rate the communication behaviour. Results from the two assessment methods were correlated at both time points and possible differences from T1 to T2 were explored. A close to zero correlation between self-efficacy and observed communication skills were found at T1. At T2, participants' self-efficacy scores were inversely correlated with levels of observed skills, demonstrating a lack of concordance between young physicians' own assessment of self-efficacy and observers' assessment. When dividing the sample in three groups based on the observers' scores (low <1/3-, medium 1/3 to 2/3-, high competence >2/3), the group of male physicians showed higher levels of self-efficacy than females in all the three performance groups at T1. At T2, those having a high performance score yielded a low self-efficacy, regardless of gender. The lack of positive correlations between self-efficacy assessment and expert ratings points to limitations in the applicability of self-assessment measures of communication skills. Due to gender differences, groups of female and male physicians should be investigated separately. Those obtaining high-performance ratings from observers, through the period of internship, may become more conscious of how demanding clinical communication with

Peripheral nerve field stimulation (PNFS) in chronic low back pain: a prospective multicenter study.

PubMed

Kloimstein, Herwig; Likar, Rudolf; Kern, Michael; Neuhold, Josef; Cada, Miroslav; Loinig, Nadja; Ilias, Wilfried; Freundl, Brigitta; Binder, Heinrich; Wolf, Andreas; Dorn, Christian; Mozes-Balla, Eva Maria; Stein, Rolf; Lappe, Ivo; Sator-Katzenschlager, Sabine

2014-02-01

The goal of this study was to evaluate the long-term efficacy and safety of peripheral nerve field stimulation (PNFS) for chronic low back pain (cLBP). In this prospective, multicenter observational study, 118 patients were admitted to 11 centers throughout Austria and Switzerland. After a screening visit, all patients underwent a trial stimulation period of at least seven days before implantation of the permanent system. Leads were placed in the subcutaneous tissues of the lower back directly in the region of greatest pain. One hundred five patients were implanted with a permanent stimulating system. Patients' evaluation of pain and functional levels were completed before implantation and one, three, and six months after implantation. Adverse events, medication usage, and coverage of the painful area and predictive value of transcutaneous electrical nerve stimulation (TENS) were monitored. All pain and quality-of-life measures showed statistically significant improvement during the treatment period. These included the average pain visual analog scale, the Oswestry Disability Questionnaire, the Becks Depression Inventory, and the Short Form-12 item Health survey. Additionally, medication usage with opioids, nonsteroidal anti-inflammatory drugs, and anti-convulsants showed a highly significant reduction. Complications requiring surgical intervention were reported in 9.6% of the patients. The degree of coverage of painful areas seems to be an important criterion for efficacy of PNFS, whereas TENS is presumably no predictor. This prospective, multicenter study confirms that PNFS is an effective therapy for the management of cLBP. Significant improvements in many aspects of the pain condition were measured, and complications were minimal. © 2013 International Neuromodulation Society.

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 safety and efficacy of 980-nm diode laser-assisted lipolysis versus traditional liposuction for submental rejuvenation: A randomized clinical trial.

PubMed

Valizadeh, Neda; Jalaly, Niloofar Y; Zarghampour, Manijeh; Barikbin, Behrooz; Haghighatkhah, Hamid Reza

2016-01-01

Submental fat accumulation and skin laxity is a frequent concern of cosmetic patients. The aim of this randomized prospective controlled clinical trial was to compare the efficacy and safety of laser-assisted lipolysis and liposuction in the submental rejuvenation. Thirty-six female adults were enrolled in this clinical trial and were categorized into two groups: group 1 underwent 980-nm diode laser with the power of 6-8 W and group 2 underwent traditional liposuction. Patients were evaluated with ultrasonography 2 weeks and 2 months after the procedures. Ultrasonographic evaluation reported the significant reduction of fat thickness in each group compared with the baseline (p value < 0.001). At the 2 weeks and 2 months follow-up visit, fat thickness reduction was significantly higher in the lipolysis group (p value < 0.05). Overall patients' satisfaction in lipolysis group was higher than liposuction with 11 (61%) of lipolysis patients being very satisfied in contrast to 10 (55.5%) of liposuction patients reporting "dissatisfied or neutral" results. Laser-assisted lipolysis using 980-nm diode is approved to be safe and effective for skin tightening and rejuvenation of the submental area and seems to be a better option than traditional techniques for treatment of this cosmetic problem.

[The efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women: a randomized, prospective, multicenter study].

PubMed

Rafal'skiĭ, V V; Dovgan', E V; Kozyrev, Iu V; Gustovarova, T A; Khlybova, S V; Novoselova, A V; Filippenko, N G; Likhikh, D G

2013-01-01

The study was aimed to the evaluation of efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women. A prospective, multicenter, randomized study that included 112 pregnant women with asymptomatic bacteriuria was performed. 58 women were randomized in group 1 (cefixime [suprax solutab] 400 mg 1 time a day, 7 days), 54 women were included in group 2 (amoxicillin/clavulanate [amoksiklav] 625 mg 3 times a day, 7 days). The average age of the patients in group 1 was 25.2 +/- 6.6; in group 2--26.6 +/- 5.8 years. Physical examination, evaluation of complaints, collection of data on adverse reactions, and bacteriological analysis of urine were performed after enrollment in the study at visit 2 (day 10 +/- 1) and 3 (day 35 +/- 2). Comparable effectiveness of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women was found. Eradication of the pathogen and sustained bacteriological response were observed in 94.8 and 92.7% of women treated with cefixime, and in 98.2 and 92.5% of women treated with amoxicillin/clavulanate, respectively (P > 0.05). At the same time, the use of amoxicillin/clavulanate compared with cefixime significantly higher was followed by the development of adverse reactions (13% and 1.7; respectively; P = 0.02). Seven-day courses of cefixime at a dose 400 mg 1 time a day and amoxicillin/clavulanate at a dose of 625 mg 3 times a day are high-effective treatment regimens for asymptomatic bacteriuria in pregnant women in Russia. The use of amoxicillin/clavulanate is significantly more often accompanied by the development of adverse reactions compared with cefixime.

Prospective safety performance evaluation on construction sites.

PubMed

Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

2015-05-01

This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

Do Prospective Classroom Teachers Perceive Themselves as Effective and Willing to Teach Young Learners English?

ERIC Educational Resources Information Center

Sad, Süleyman Nihat

2015-01-01

This study aimed to investigate the perceived efficacy and willingness levels of prospective classroom teachers to teach English at the primary level. The study was designed as a baseline descriptive survey, followed by complementary correlational and ex post facto models. Participants were 251 prospective classroom teachers. Data was collected…

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.

Failed efficacy of ziprasidone in the treatment of post-traumatic stress disorder.

PubMed

Ramaswamy, Sriram; Driscoll, David; Smith, Lynette M; Bhatia, Subhash C; Petty, Frederick

2016-04-15

Post-traumatic stress disorder (PTSD) is a chronic anxiety disorder that is often difficult to treat. Patients suffering from PTSD often fail to respond to antidepressants and may have a high incidence of positive symptoms of psychosis, though antipsychotic medications have been minimally studied in this population. The aim of this study was to assess the impact of the atypical antipsychotic ziprasidone (Geodon) on PTSD symptom clusters, as well as comorbid major depressive disorder. To our knowledge, this is the first completed randomized controlled trial investigating the potential efficacy and tolerability of ziprasidone in patients with chronic PTSD. We conducted a 9-week prospective, randomized, double-blind, placebo-controlled trial of ziprasidone in 30 patients diagnosed with PTSD and comorbid depression. After screening and randomization, patients completed nine weekly study visits at which treatment safety and efficacy were evaluated. Primary measures of efficacy included total and subscale scores from the Clinician-Administered PTSD Scale (CAPS), while the Hamilton Rating Scale for Depression (HAM-D), Hamilton Anxiety Scale (HAM-A), Clinical Global Impression (CGI), and Treatment Outcome PTSD Scale (TOP-8) were implemented as secondary efficacy measures. We observed no significant effect of treatment on reduction of PTSD or depression symptoms from pre- to post-treatment. Our findings suggest that ziprasidone treatment may not significantly improve symptoms of PTSD or comorbid depression, though further study is needed.

Efficacy of a Multiplex Paclitaxel Emission Stent Using a Pluronic® Mixture Membrane versus a Covered Metal Stent in Malignant Biliary Obstruction: A Prospective Randomized Comparative Study.

PubMed

Jang, Sung Ill; Lee, Se Joon; Jeong, Seok; Lee, Don Haeng; Kim, Myung-Hwan; Yoon, Hong Jin; Lee, Dong Ki

2017-07-15

A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic ® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. The two groups did not differ significantly in basic characteristics and mean follow-up period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

The Diagnostic Efficacy of Cone-beam Computed Tomography in Endodontics: A Systematic Review and Analysis by a Hierarchical Model of Efficacy.

PubMed

Rosen, Eyal; Taschieri, Silvio; Del Fabbro, Massimo; Beitlitum, Ilan; Tsesis, Igor

2015-07-01

The aim of this study was to evaluate the diagnostic efficacy of cone-beam computed tomographic (CBCT) imaging in endodontics based on a systematic search and analysis of the literature using an efficacy model. A systematic search of the literature was performed to identify studies evaluating the use of CBCT imaging in endodontics. The identified studies were subjected to strict inclusion criteria followed by an analysis using a hierarchical model of efficacy (model) designed for appraisal of the literature on the levels of efficacy of a diagnostic imaging modality. Initially, 485 possible relevant articles were identified. After title and abstract screening and a full-text evaluation, 58 articles (12%) that met the inclusion criteria were analyzed and allocated to levels of efficacy. Most eligible articles (n = 52, 90%) evaluated technical characteristics or the accuracy of CBCT imaging, which was defined in this model as low levels of efficacy. Only 6 articles (10%) proclaimed to evaluate the efficacy of CBCT imaging to support the practitioner's decision making; treatment planning; and, ultimately, the treatment outcome, which was defined as higher levels of efficacy. The expected ultimate benefit of CBCT imaging to the endodontic patient as evaluated by its level of diagnostic efficacy is unclear and is mainly limited to its technical and diagnostic accuracy efficacies. Even for these low levels of efficacy, current knowledge is limited. Therefore, a cautious and rational approach is advised when considering CBCT imaging for endodontic purposes. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Prospective evaluation of the feasibility, safety, and efficacy of Cocoon Duct Occluder for transcatheter closure of large patent ductus arteriosus: A single-center study with short- and medium-term follow-up results

PubMed Central

Sinha, Santosh Kumar; Razi, Mahmadula; Pandey, Rama Niwas; Kumar, Prakash; Krishna, Vinay; Jha, Mukesh Jitendra; Mishra, Vikas; Asif, Mohammad; Abdali, Nasar; Tewari, Pradyot; Thakur, Ramesh; Pandey, Umeshwar; Varma, Chandra Mohan

2017-01-01

Objective: To evaluate the feasibility, safety, and efficacy of a novel Cocoon Duct Occluder device for the transcatheter closure (TCC) of large patent ductus arteriosus (PDA). Methods: In this prospective, non-randomized study, consecutive patients with large PDA (narrowest diameter: ≥3.5/4.0 mm in symptomatic/asymptomatic patients, respectively), who underwent TCC with Cocoon Duct Occluder at our institute between November, 2012 and June, 2016 were examined. TCC was performed using the standard technique, and devices were antegradely delivered via 6–10F delivery sheaths. Device embolization, residual shunt, hemolysis, left pulmonary artery (LPA) stenosis, procedural and fluoroscopy time, and mortality were assessed. Patients were followed-up by transthoracic echocardiography with color Doppler imaging at 24 h (D1), 1 month (D30), and 6 months (D180) after implantation. Results: A total of 57 patients (age: 11.7±2.8 years; weight: 22.3±3.5 kg) were enrolled. The mean narrowest diameter was 7.4±0.7 mm. The PDA closure was successfully performed in each patient. Fluoroscopy and procedural time was 6.7±3.2 min and 23.9±2.7 min, respectively. Postprocedural angiography revealed that 49 (85.9%) patients had immediate and complete closure, whereas 8 (14.1%) had residual shunt. Color Doppler imaging at D1 revealed complete closure in 52 (91.3%) patients. At D30, complete closure was reported in all patients and was maintained at D180. Hemolysis, embolization, obstruction of LPA or descending aorta, and death were not reported till D180. Conclusion: TCC using Cocoon Duct Occluder is feasible, safe, and effective in the management of patients with large PDA, with excellent results on short- and medium-term follow-up. PMID:29145233

Role of affective self-regulatory efficacy in diverse spheres of psychosocial functioning.

PubMed

Bandura, Albert; Caprara, Gian Vittorio; Barbaranelli, Claudio; Gerbino, Maria; Pastorelli, Concetta

2003-01-01

This prospective study with 464 older adolescents (14 to 19 years at Time 1; 16 to 21 years at Time 2) tested the structural paths of influence through which perceived self-efficacy for affect regulation operates in concert with perceived behavioral efficacy in governing diverse spheres of psychosocial functioning. Self-efficacy to regulate positive and negative affect is accompanied by high efficacy to manage one's academic development, to resist social pressures for antisocial activities, and to engage oneself with empathy in others' emotional experiences. Perceived self-efficacy for affect regulation essentially operated mediationally through the latter behavioral forms of self-efficacy rather than directly on prosocial behavior, delinquent conduct, and depression. Perceived empathic self-efficacy functioned as a generalized contributor to psychosocial functioning. It was accompanied by prosocial behavior and low involvement in delinquency but increased vulnerability to depression in adolescent females.

Efficacy and safety of the topical application of tranexamic acid in primary cementless hip arthroplasty: prospective, randomised, double-blind and controlled study.

PubMed

Tavares Sánchez-Monge, F J; Aguado Maestro, I; Bañuelos Díaz, A; Martín Ferrero, M Á; García Alonso, M F

To evaluate the efficacy of topical tranexamic acid topical in cementless total hip arthroplasty from the point of view of bleeding, transfusion requirements and length of stay, and describe the complications of use compared to a control group. A prospective, randomised, double-blinded and controlled study including all patients undergoing cementless total hip arthroplasty in our centre between June 2014 and July 2015. Blood loss was estimated using the formula described by Nadler and Good. The final analysis included 119 patients. The decrease in haemoglobin after surgery was lower in the tranexamic acid group (3.28±1.13g/dL) than in the controls (4.03±1.27g/dL, P=.001) and estimated blood loss (1,216.75±410.46mL vs. 1,542.12±498.97mL, P<.001), the percentage of transfused patients (35.9% vs. 19.3%, P<.05) and the number of transfused red blood cell units per patient (0.37±0.77 vs. 0.98±1.77; P<.05). There were no differences between groups in the occurrence of complications or length of stay. The use of topical tranexamic acid in cementless total hip arthroplasty results in a decrease in bleeding and transfusion requirements without increasing the incidence of complications. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Efficacy and safety of fosfomycin-trometamol in the prophylaxis for transrectal prostate biopsy. Prospective randomized comparison with ciprofloxacin.

PubMed

Lista, F; Redondo, C; Meilán, E; García-Tello, A; Ramón de Fata, F; Angulo, J C

2014-01-01

Prostate biopsy is the standardized diagnostic method for prostate cancer. However, although there is not a standardized protocol, there are recommendations in order to reduce the incidence of complications. The objective of the present work is to assess the efficacy and safety of antibiotic prophylaxis in the prostate biopsy by comparing two antibiotic regimes: two doses of fosfomycin-trometamol 3g (FMT) every 48 hours with 10 doses of oral ciprofloxacin 500 mg every 12 hours during 5 days. Randomized prospective study was performed with 671 patients who had undergone to walking transrectal ultrasound guided prostate biopsy. Patients of group A (n=312) were treated with ciprofloxacin, and patients of group B (n=359) with FMT. Efficacy and tolerability of two prophylactic regimes were compared. Urine culture was carried out at 2 weeks after biopsy. Initially, patients with asymptomatic bacteriuria were not treated with antibiotics; urine culture was repeated after 1 month, persistent bacteriuria was treated according to antibiogram. No differences between groups were found in age (P=.78), cancer presence (P=.9) or number of biopsy cylinders (P=.93). The mean number of cores obtained was 11.3 ± 3.25 (range 6-20). Digestive intolerance was observed for 9 patients (2.9%) of group A and 10 patients (2.8%) in group B. One patient (.3%) of group A showed severe allergic reaction. In total, 167 patients (24.6%) had complications: 16 (2.4%) fever, 47 (6.9%) hemospermia, 81 (11.9%) hematuria, 7 (1%) rectal bleeding and 16 (2.4%) urinary retention. No statistically differences between groups were observed (27.6% vs. 22.6%; P=.17). However, hemospermia was more frequent in group A (9.9% vs. 4.5%; P=.006). Bacteriuria after biopsy was detected in 44 patients (6.6%), being more frequent in group B patients (4.2% vs. 8.6%; P=.02) although a higher number of second treatment cycles were not needed (53.9% vs. 29%; P=.17). The likelihood of resistance to ciprofloxacin in patients

Management of 2nd-degree facial burns using the Versajet(®) hydrosurgery system and xenograft: a prospective evaluation of 20 cases.

PubMed

Duteille, Franck; Perrot, Pierre

2012-08-01

There is no single therapeutic scheme for the management of intermediary 2nd-degree facial burns, which can cause problems because of their uncertain course. It is preferable to obtain optimal healing of the face in order to avoid functional or cosmetic sequelae. Some practitioners recommend early excision (first week) of these burns, whereas others prefer to wait and perform surgery later (after 2 weeks). The practice in our burns unit is early surgery (from the first week) associated with hydrosurgical excision and application of a biosynthetic dressing (xenograft). A prospective follow-up of 20 cases was carried out to evaluate the efficacy of our protocol. The prospective evaluation was performed with follow-up at 2 weeks and 3, 6 and 12 months. The patients included had intermediary 2nd-degree burns on at least 15% of the face and no life-threatening prognosis. The mean age in our series was 40.5 years (16-72), the mean percentage of burn surface area was 27.75% and the mean percentage of facial burn was 60.75%. Early excision was performed (day 5-10) using the Versajet(®) system, which allows tangential water-dissection. Porcine xenograft (E-Z Derm(®)) was applied immediately afterwards. Patients whose healing process was not complete at 2 weeks were then scheduled to receive a thin autograft. Patients were followed up 2 weeks, 3, 6 and 12 months after discharge. Excision was performed at a mean 7.6 days, and mean initial healing time was 13.4 days. In three cases, a full-thickness skin graft was used, whereas healing occurred in the other patients without further grafts. Two patients had functional sequelae (ectropion) corrected later by repair surgery. The course of healing for the other patients proceeded normally. There is no consensus about the management of intermediate depth 2nd-degree facial burns. We chose to perform early surgery using the Versajet(®) system, which allows fine, precise excision, leaving nearly all of the healthy tissue in place

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

ERIC Educational Resources Information Center

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

2014-01-01

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

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.

Reflections on urban science teacher-student self-efficacy dynamics

NASA Astrophysics Data System (ADS)

Hagiwara, Sumi; Maulucci, Maria S. Rivera; Ramos, S. Lizette

2011-12-01

This forum article consists of commentaries—authored by Sumi Hagiwara, Maria S. Rivera Maulucci and Lizette Ramos—on the feature article by Virginia Jennings Bolshakova, Carla C. Johnson, and Charlene M. Czerniak. We reflect on a series of questions that take retrospective, introspective, and prospective views of self-efficacy in science education. We review selected studies that explore some of the historical developments and methodological approaches in the literature and examine a teacher-student self-efficacy system model that shows the ways in which teachers' and students' self-efficacy judgments are based upon multiple individual and shared components, such as identity and social interaction within the classroom and school. We close with a call for the design of measures of teacher-student self-efficacy systems, so that we can begin to tailor professional development experiences to the goals and motivations of individual and collective groups of teachers and students in ways that accommodate the unique cultural features of their classrooms and foster student self-efficacy.

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.

EVALUATING THE POTENTIAL EFFICACY OF AN ANTIMICROBIAL-CONTAINING SEALANT ON DUCT LINER AND GALVANIZED STEEL

EPA Science Inventory

The article gives results of an evaluation of the potential efficacy of an antimicrobial-containing sealant on fibrous-glass duct liner (FGDL) and galvanized steel (GS) as used in heating, ventilating, and air-conditioning (HVAC) systems. HVAC systems become dirty to various degr...

Parental self-efficacy and its measurement - an evaluation of a parental self-efficacy measurement scale.

PubMed

Purssell, Edward; While, Alison

2013-05-01

To field test a parental self-efficacy scale regarding its acceptability and feasibility and to describe parental self-efficacy in a convenience sample of parents with children aged 6 years old or less. Self-care within families is increasingly emphasised in health policy as a means of maximising healthcare resources. This study reports the field testing of a scale designed to measure parental self-efficacy. Cross-sectional survey of parents of children aged 6 years old or less. Subjects were recruited through a parenting internet website (n = 84) and local parenting and community organisations (n = 68) and asked to complete a questionnaire containing the scale. Data collection took place between January and August 2011. The scale, previously validated with an expert panel of professionals, gathered information about parental self-efficacy when administered either directly or through an on-line data collection portal, although there were more missing data when administered via the Internet. Although convenience and self-selecting samples precluded parameter estimation, areas of concern highlighted were difficulties differentiating children with serious illnesses and the use of the Personal Child Health Record. Use of the Internet was widespread, as was use of community pharmacists and nursery staff. Although the primary purpose was not to collect specific data, the data indicated the continuing concern of parents regarding serious illness and where additional investment may be required to meet parental needs and expectations. The previously validated scale can be used to collect information about parental self-efficacy either through a paper questionnaire or the Internet. Although there was slightly more missing data from the Internet version, the ease of its administration makes this an attractive option. Parents generally reported high levels of self-efficacy and satisfaction with services; however, the scale was able to identify areas where further investment

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.

Prospective analysis of percutaneous endoscopic colostomy at a tertiary referral centre.

PubMed

Baraza, W; Brown, S; McAlindon, M; Hurlstone, P

2007-11-01

Percutaneous endoscopic colostomy (PEC) is an alternative to surgery in selected patients with recurrent sigmoid volvulus, recurrent pseudo-obstruction or severe slow-transit constipation. A percutaneous tube acts as an irrigation or decompressant channel, or as a mode of sigmoidopexy. This prospective study evaluated the safety and efficacy of this procedure at a single tertiary referral centre. Nineteen patients with recurrent sigmoid volvulus, ten with idiopathic slow-transit constipation and four with pseudo-obstruction underwent PEC. The tube was left in place indefinitely in those with recurrent sigmoid volvulus or constipation, whereas in patients with pseudo-obstruction it was left in place for a variable period of time, depending on symptoms. Thirty-five procedures were performed in 33 patients. Three patients developed peritonitis, of whom one died, and ten patients had minor complications. Symptoms resolved in 26 patients. This large prospective study has confirmed the value of PEC in the treatment of recurrent sigmoid volvulus and pseudo-obstruction in high-risk surgical patients. Copyright (c) 2007 British Journal of Surgery Society Ltd.

Comparison of turbinoplasty surgery efficacy in patients with and without allergic rhinitis.

PubMed

Hamerschmidt, Rodrigo; Hamerschmidt, Rogério; Moreira, Ana Tereza Ramos; Tenório, Sérgio Bernardo; Timi, Jorge Rufno Ribas

2016-01-01

Turbinoplasty is a procedure that aims to reduce the size of the inferior turbinate through exuberant bone removal with high mucosal preservation. The procedure is recommended for patients with or without allergic rhinitis and those showing irreversible hypertrophy of inferior turbinates. To evaluate the efficacy of inferior turbinoplasty for obstructive and non-obstructive symptoms in patients with or without allergic rhinitis. Prospective study with 57 patients who underwent inferior turbinoplasty. They were evaluated for nasal obstruction, snoring, facial pressure, smell alterations, sneezing, nasal itching and runny nose symptoms, surgery time, and intraoperative bleeding. The last evaluation took place three months after surgery. Thirty-nine patients with allergic rhinitis and 18 without were assessed. Ninety days after surgery, 94.7% of patients showed degrees IV and V of breathing improvement; 89.5% showed moderate or complete improvement in snoring; all patients showed smell improvement (only one showed moderate improvement; all the others had full improvement); 95.5% experienced complete facial pressure improvement; and 89.7% showed moderate to complete improvement in nasal itching and runny nose symptoms, as well as in sneezing. The efficacy of inferior turbinoplasty was confirmed not only for obstructive symptoms, but also for non-obstructive symptoms in patients with and without allergic rhinitis. Copyright © 2015 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Evaluating the Dissemination of "Body & Soul," an Evidence-based Fruit and Vegetable Intake Intervention: Challenges for Dissemination and Implementation Research

ERIC Educational Resources Information Center

Allicock, Marlyn; Campbell, Marci K.; Valle, Carmina G.; Carr, Carol; Resnicow, Ken; Gizlice, Ziya

2012-01-01

Objective: To evaluate whether the evidence-based "Body & Soul" program, when disseminated and implemented without researcher or agency involvement and support, would achieve results similar to those of earlier efficacy and effectiveness trials. Design: Prospective group randomized trial. Setting: Churches with predominantly African American…

The development and initial evaluation of the Pornography-Use Avoidance Self-Efficacy Scale

PubMed Central

Kraus, Shane W.; Rosenberg, Harold; Martino, Steve; Nich, Charla; Potenza, Marc N.

2017-01-01

Background and aims This study employed a newly developed questionnaire to evaluate whether men’s self-efficacy to avoid using pornography in each of 18 emotional, social, or sexually arousing situations was associated with either their typical frequency of pornography use or their hypersexuality. Methods Using an Internet-based data collection procedure, 229 male pornography users (Mage = 33.3 years, SD = 12.2) who had sought or considered seeking professional help for their use of pornography completed questionnaires assessing their situationally specific self-efficacy, history of pornography use, self-efficacy to employ specific pornography-reduction strategies, hypersexuality, and demographic characteristics. Results Frequency of pornography use was significantly negatively associated with level of confidence in 12 of the 18 situations. In addition, lower hypersexuality and higher confidence to employ pornography-use-reduction strategies were associated with higher confidence to avoid using pornography in each of the 18 situations. A principal axis factor analysis yielded three clusters of situations: (a) sexual arousal/boredom/opportunity, (b) intoxication/locations/easy access, and (c) negative emotions. Discussion and conclusions This questionnaire could be employed to identify specific high-risk situations for lapse or relapse and as a measure of treatment outcome among therapy clients, but we recommend further examination of the psychometric properties and clinical utility of the questionnaire in treatment samples. Because only one of the three clusters reflected a consistent theme, we do not recommend averaging self-efficacy within factors to create subscales. PMID:28889754

The development and initial evaluation of the Pornography-Use Avoidance Self-Efficacy Scale.

PubMed

Kraus, Shane W; Rosenberg, Harold; Martino, Steve; Nich, Charla; Potenza, Marc N

2017-09-01

Background and aims This study employed a newly developed questionnaire to evaluate whether men's self-efficacy to avoid using pornography in each of 18 emotional, social, or sexually arousing situations was associated with either their typical frequency of pornography use or their hypersexuality. Methods Using an Internet-based data collection procedure, 229 male pornography users (M age  = 33.3 years, SD = 12.2) who had sought or considered seeking professional help for their use of pornography completed questionnaires assessing their situationally specific self-efficacy, history of pornography use, self-efficacy to employ specific pornography-reduction strategies, hypersexuality, and demographic characteristics. Results Frequency of pornography use was significantly negatively associated with level of confidence in 12 of the 18 situations. In addition, lower hypersexuality and higher confidence to employ pornography-use-reduction strategies were associated with higher confidence to avoid using pornography in each of the 18 situations. A principal axis factor analysis yielded three clusters of situations: (a) sexual arousal/boredom/opportunity, (b) intoxication/locations/easy access, and (c) negative emotions. Discussion and conclusions This questionnaire could be employed to identify specific high-risk situations for lapse or relapse and as a measure of treatment outcome among therapy clients, but we recommend further examination of the psychometric properties and clinical utility of the questionnaire in treatment samples. Because only one of the three clusters reflected a consistent theme, we do not recommend averaging self-efficacy within factors to create subscales.

Fractional carbon dioxide laser for the treatment of facial atrophic acne scars: prospective clinical trial with short and long-term evaluation.

PubMed

Elcin, Gonca; Yalici-Armagan, Basak

2017-12-01

The aim of this study was to evaluate the efficacy and safety of fractional carbon dioxide laser for the treatment of acne scars. Thirty-one participants, 15 female and 16 male, whose mean age was 34.84 ± 10.94 years, were included in this prospective study. The study took place between 2012 and 2016. Participants were evaluated with the "ECCA Grading Scale" before the first session, 3 months (short-term evaluation) and 3 years after the last session (long-term evaluation). Participants received two or three treatment sessions at 4-week intervals, with a 10,600 nm fractional carbon dioxide laser with pulse energies ranging between 100 and 160 mJ, 120 spot type, 75-100 spot/cm 2 density, and 30 W power. Self-assessments by the participants were done 3 months and 3 years after the last session. The mean ECCA score was 107.90 ± 39.38 before the first session, and 82.17 ± 36.23 at the time of short-term evaluation (p = 0.000). The grade of improvement at the short-term evaluation was as follows: no improvement, mild, moderate, and significant improvement for 7 (22.6%), 11 (35.5%), 9 (29%), and 4 (12.9%) of the participants, respectively. Regarding self-assessments, 80.6 and 61.3% of the participants rated themselves as having at least mild improvement at the short-term and the long-term follow-up periods, respectively. The results of this study suggest that fractional carbon dioxide laser is an efficient treatment option for acne scars. Furthermore, self-assessment results show that more than half of the participants still experience at least mild improvement at the end of 3 years.

Hypoparathyroidism after total thyroidectomy: prospective evaluation and relation with early hypocalcemia.

PubMed

D'Alessandro, Nicola; Tramutola, Giuseppe; Fasano, Giovanni Michele; Gilio, Francesco; Iside, Giovanni; Izzo, Maria Lucia; Loffredo, Andrea; Pici, Mariano; Pinto, Margherita; Tramontano, Salvatore; Citro, Giuseppe

2016-01-01

Definitive hypoparathyrodism (hypo-PTH) represents one of the most dangerous complication after total thyroidectomy. Partial or total lesion or accidental removal of parathyroid glands is an unpredictable adverse event, although real incidence is not well defined, such as management of this deficit. We started a prospective evaluation of patients treated with total thyroidectomy in our centre, to identify incidence of hypo-PTH, symptomatic or not, in relation to incidence of early postoperative hypocalcemia in our experience. We prospectively evaluated 177 patients treated for benign and malign pathology, measuring calcium before surgery and calcium and PTH at least three months after surgery. Postoperative hypocalcemia was observed in 37.3% of cases. Eight patients (4.5% of cohort) presented low level of PTH, at mean follow-up of 9.1 months. Positive predictive value for postoperative hypocalcemia was 12.1%, while negative predictive was 95.4%; confirming high sensitivity (100%) and low specificity (65.4%) for detecting hypo-PTH. All patients with late hypo-PTH presented hypocalcemia on early analysis, while no case with normal postoperative calcemia accounted with hypo-PTH: this may indicate calcemia as valid prognostic factor of good gland production, when is in the range. Moreover, isolated analysis is too limited to determine real predictability. Technical standardization represents the best method for prevention of hypo-PTH. Early hypocalcemia is a prognostic factor, even with a low specificity, of deficit of PTH-production. This observation must be related to other known prognostic factors. Postoperative normal calcemia should be a positive prognostic factor of an acceptable PTHfunction, supported by large cohorts. Hypocalcemia, Parathormone, Thyroidectomy.

Self-efficacy pathways to childhood depression.

PubMed

Bandura, A; Pastorelli, C; Barbaranelli, C; Caprara, G V

1999-02-01

This prospective research analyzed how different facets of perceived self-efficacy operate in concert within a network of sociocognitive influences in childhood depression. Perceived social and academic inefficacy contributed to concurrent and subsequent depression both directly and through their impact on academic achievement, prosocialness, and problem behaviors. In the shorter run, children were depressed over beliefs in their academic inefficacy rather than over their actual academic performances. In the longer run, the impact of a low sense of academic efficacy on depression was mediated through academic achievement, problem behavior, and prior depression. Perceived social inefficacy had a heavier impact on depression in girls than in boys in the longer term. Depression was also more strongly linked over time for girls than for boys.

Two-Center Evaluation of Disinfectant Efficacy against Ebola Virus in Clinical and Laboratory Matrices.

PubMed

Smither, Sophie J; Eastaugh, Lin; Filone, Claire Marie; Freeburger, Denise; Herzog, Artemas; Lever, M Stephen; Miller, David M; Mitzel, Dana; Noah, James W; Reddick-Elick, Mary S; Reese, Amy; Schuit, Michael; Wlazlowski, Carly B; Hevey, Michael; Wahl-Jensen, Victoria

2018-01-01

Ebola virus (EBOV) in body fluids poses risk for virus transmission. However, there are limited experimental data for such matrices on the disinfectant efficacy against EBOV. We evaluated the effectiveness of disinfectants against EBOV in blood on surfaces. Only 5% peracetic acid consistently reduced EBOV titers in dried blood to the assay limit of quantification.

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.…

Between-individual comparisons in performance evaluation: a perspective from prospect theory.

PubMed

Wong, Kin Fai Ellick; Kwong, Jessica Y Y

2005-03-01

This article examines how between-individual comparisons influence performance evaluations in rating tasks. The authors demonstrated a systematic change in the perceived difference across ratees as a result of changing the way performance information is expressed. Study 1 found that perceived performance difference between 2 individuals was greater when their objective performance levels were presented with small numbers (e.g., absence rates of 2% vs. 5%) than when they were presented with large numbers (e.g., attendance rates of 98% vs. 95%). Extending this finding to situations involving trade-offs between multiple performance attributes across ratees, Study 2 showed that the relative preference for 1 ratee over another actually reversed when the presentation format of the performance information changed. The authors draw upon prospect theory to offer a theoretical framework describing the between-individual comparison aspect of performance evaluation.

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.

Efficacy of a checklist as part of a physical medicine and rehabilitation clerkship to teach medical students musculoskeletal physical examination skills: a prospective study.

PubMed

Altschuler, Eric L; Cruz, Eduardo; Salim, Sara Z; Jani, Jay B; Stitik, Todd P; Foye, Patrick M; DeLisa, Joel A

2014-01-01

The aim of this study was to evaluate the efficacy of a checklist as part of a physical medicine clerkship to teach medical students physical examination maneuvers. This is a prospective study performed on fourth year medical students enrolled in a 2-wk mandatory clerkship of the Department of Physical Medicine and Rehabilitation. At the start and end of the rotation, the participating students were tested by performing 20 physical examination maneuvers on an investigator who was both the standardized patient and the evaluator. At the end of the rotation, the students also completed a survey. Data were analyzed using the Bernoulli trial model, with the percentage of students who performed the maneuver correctly on the pretest as the a priori probability. A full Bonferroni correction was applied. The authors enrolled 141 of the 176 fourth year medical students; 121 completed testing. At prerotation, approximately 35% of the physical examination maneuvers were performed correctly; at postrotation, 82%. For 19 of 20 maneuvers, the improvement was statistically significant at P < 0.01. The survey results indicated that the students felt that they had limited exposure to musculoskeletal examination skills at prerotation, that this rotation helped them achieve competency in performing the maneuvers, and that this would improve their future patient care irrespective of field of choice. Considering the high prevalence of musculoskeletal disorders and the anticipated rise in the future, the authors strongly recommend teaching musculoskeletal physical examination maneuvers in medical school, which can be accomplished via a mandatory physical medicine and rehabilitation rotation. The authors conclude that checklists as part of this rotation can effectively help in teaching physical examination skills to medical students.

Evaluation of the efficacy of keratinized mucosa augmentation techniques around dental implants: a systematic review.

PubMed

Wu, Qingqing; Qu, Yili; Gong, Ping; Wang, Tianlu; Gong, Ting; Man, Yi

2015-05-01

The absence of periimplant keratinized mucosa is considered risky in patients with a predisposition to periodontitis or recession. Although various soft tissue augmentation techniques exist, dentists are seeking for more efficient approaches to augment periimplant keratinized mucosa. The purpose of this systematic review was to evaluate the efficacy of the various techniques and biomaterials adopted in periimplant keratinized mucosa augmentation and whether one technique or biomaterial is superior. A search in Medline-PubMed and the Cochrane Central Register of controlled trials was conducted. Randomized clinical trials, prospective cohort studies, clinical control studies, and case series from January 1, 1980, to December 31, 2013, with a follow-up of at least 6 months reporting changes on keratinized mucosa width were included. Several journals were hand-searched for related articles. The bibliographies of all publications selected for inclusion were also scanned. The screening of titles and abstracts resulted in 60 relevant publications. Six of them were finally included. Free gingival graft, connective tissue graft, acellular dermal matrix, and collagen matrix were used for keratinized mucosa augmentation. Because of heterogeneity of the studies, only descriptive analysis was performed. Improvements in keratinized mucosa width were reported in all studies. A definitive conclusion could not be achieved owing to the lack of well-designed studies and appropriate methods of studying soft tissue. The establishment of universal surgical guidelines and measurement systems is imperative in the future. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

78 FR 34664 - Prospective Grant of Start-up Exclusive Evaluation License: Portable Device and Method for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-up Exclusive Evaluation License: Portable Device and Method for Detecting Hematomas AGENCY: National... device and method for detecting hematomas based on near infrared light emitted perpendicularly into a...

Reflections on Urban Science Teacher-Student Self-Efficacy Dynamics

ERIC Educational Resources Information Center

Hagiwara, Sumi; Maulucci, Maria S. Rivera; Ramos, S. Lizette

2011-01-01

This forum article consists of commentaries--authored by Sumi Hagiwara, Maria S. Rivera Maulucci and Lizette Ramos--on the feature article by Virginia Jennings Bolshakova, Carla C. Johnson, and Charlene M. Czerniak. We reflect on a series of questions that take retrospective, introspective, and prospective views of self-efficacy in science…

Efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy: A prospective, randomized study

PubMed Central

Akaraviputh, Thawatchai; Leelouhapong, Charay; Lohsiriwat, Varut; Aroonpruksakul, Somkiat

2009-01-01

AIM: To determine the efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy. METHODS: A prospective, double-blind, randomized, placebo-controlled study was conducted on 70 patients who underwent elective laparoscopic cholecystectomy under general anesthesia at Siriraj Hospital, Bangkok, from January 2006 to December 2007. Patients were randomized to receive either 20 mg parecoxib infusion 30 min before induction of anesthesia and at 12 h after the first dose (treatment group), or normal saline infusion, in the same schedule, as a placebo (control group). The degree of the postoperative pain was assessed every 3 h in the first 24 h after surgery, and then every 12 h the following day, using a visual analog scale. The consumption of analgesics was also recorded. RESULTS: There were 40 patients in the treatment group, and 30 patients in the control group. The pain scores at each time point, and analgesic consumption did not differ between the two groups. However, there were fewer patients in the treatment group than placebo group who required opioid infusion within the first 24 h (60% vs 37%, P = 0.053). CONCLUSION: Perioperative administration of parecoxib provided no significant effect on postoperative pain relief after laparoscopic cholecystectomy. However, preoperative infusion 20 mg parecoxib could significantly reduce the postoperative opioid consumption. PMID:19399934

Two-Center Evaluation of Disinfectant Efficacy against Ebola Virus in Clinical and Laboratory Matrices

PubMed Central

Smither, Sophie J.; Eastaugh, Lin; Filone, Claire Marie; Freeburger, Denise; Herzog, Artemas; Lever, M. Stephen; Miller, David M.; Mitzel, Dana; Noah, James W.; Reddick-Elick, Mary S.; Reese, Amy; Schuit, Michael; Wlazlowski, Carly B.; Hevey, Michael

2018-01-01

Ebola virus (EBOV) in body fluids poses risk for virus transmission. However, there are limited experimental data for such matrices on the disinfectant efficacy against EBOV. We evaluated the effectiveness of disinfectants against EBOV in blood on surfaces. Only 5% peracetic acid consistently reduced EBOV titers in dried blood to the assay limit of quantification. PMID:29261093

[The current state and prospect of Chinese medicine gastroenterology].

PubMed

Zhang, Sheng-Sheng; Zhou, Tao

2012-03-01

The progress and existent problems of Chinese medicine (CM) gastroenterology since the National Eleventh Five-Year Plan were discussed in this article in terms of theory innovation, formulation of clinical pathway and diagnosis-treatment consensus, efficacy assessment, formulation of efficacy assessment scale, advantage diseases, and exploration of the syndrome standardization, progress in science research, academic exchange, and the construction of study platform, and so on. Meanwhile, the development of CM gastroenterology was prospected in the following five aspects: to enhance the theory inheritance and innovation, the construction of discipline standardization; to establish scientific clinical efficacy assessment methods and the standard system; to expend treatment technologies and feature therapies; and to clarify the modern scientific connotation of CM theory and treatment.

Efficacy and safety of lacosamide in infants and young children with refractory focal epilepsy.

PubMed

Grosso, Salvatore; Parisi, Pasquale; Spalice, Alberto; Verrotti, Alberto; Balestri, Paolo

2014-01-01

Lacosamide is effective and well-tolerated antiepileptic drug (AED) in both children and adults. This multicentric, prospective study investigates the efficacy and safety of lacosamide adjunctive therapy in children aged less than four years presenting with refractory focal seizures. Lacosamide was added to the baseline therapy at a starting dose of 1-2 mg/kg/day and titrated to the final dose, ranging from 7 to 15.5 mg/kg/day. Efficacy was evaluated after a three-month period of therapy. When possible, we compared the initial efficacy and the retention after a minimum of 12 months of lacosamide, with regard to loss of efficacy (defined as the return to the baseline seizure frequency). Twenty-four children were enrolled in the study. Mean age was 2.7 years. After a minimum three-month period of lacosamide add-on therapy, ten (42%) patients were responders (more than a 50% decrease in seizure frequency), of whom 4 (17%) became seizure free. Retention rate, after a minimum of 12 months of lacosamide, was evaluated in a group of 18 patients. In the latter group, eight patients (44%) were initial responders (three of whom seizure free). After 12 months of follow-up, four of them (22%) maintained the improvement, 2 (11%) of whom remained seizure free. A loss of efficacy was observed in 4 of the initial responders (50%). Adverse events were seen in 8 (33%) patients. We conclude that lacosamide is an effective and a well-tolerated antiepileptic drug in an etiologically wide range of focal seizures. Therefore, lacosamide might represent a possible therapeutic option in infants and young children affected by uncontrolled focal epilepsy. Copyright © 2013 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Prospective evaluation of Ki-67 system in histological grading of soft tissue sarcomas in the Japan Clinical Oncology Group Study JCOG0304.

PubMed

Tanaka, Kazuhiro; Hasegawa, Tadashi; Nojima, Takayuki; Oda, Yoshinao; Mizusawa, Junki; Fukuda, Haruhiko; Iwamoto, Yukihide

2016-04-18

The correct clinical staging of soft tissue sarcomas (STS) is critical for the selection of treatments. The staging system consists of histological grade of the tumors and French Federation of Cancer Center (FNCLCC) system based on mitotic count is widely used for the grading. In this study, we compared the validity and usefulness of Ki-67 grading system with FNCLCC system in JCOG0304 trial which investigated the efficacy and safety of perioperative chemotherapy with doxorubicin and ifosfamide for STS. All 70 eligible patients with STS in the extremities treated by perioperative chemotherapy in JCOG0304 were analyzed. Univariate and multivariate Cox regression analyses were conducted to investigate an influence on overall survival. The reproducibility of Ki-67 grading system in the histological grading of STS was higher than FNCLCC system (κ = 0.54 [95 % CI 0.39-0.71], and 0.46 [0.32-0.62], respectively). Although FNCLCC grade was not associated with overall survival (OS) in univariate analysis (HR 2.80 [0.74-10.55], p = 0.13), Ki-67 grading system had a tendency to associate with OS in univariate analysis (HR 4.12 [0.89-19.09], p = 0.07) and multivariate analysis with backward elimination (HR 3.51 [0.75-16.36], p = 0.11). This is the first report demonstrating the efficacy of Ki-67 grading system for the patients with STS in the prospective trial. The results indicate that Ki-67 grading system might be useful for the evaluation of histological grade of STS.

Reinforcement Magnitude: An Evaluation of Preference and Reinforcer Efficacy

ERIC Educational Resources Information Center

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…

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.

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.

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.

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

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

Depression and prospection.

PubMed

Roepke, Ann Marie; Seligman, Martin E P

2016-03-01

Prospection, the mental representation of possible futures, is usually adaptive. When it goes awry, however, it disrupts emotion and motivation. A negative view of the future is typically seen as one symptom of depression, but we suggest that such negative prospection is the core causal element of depression. Here, we describe the empirical evidence supporting this framework, and we explore the implications for clinical interventions. We integrate several literatures: Using the database PsycInfo, we retrieved empirical studies with the keywords prospection, prediction, expectation, pessimism, mental simulation, future-thinking, future-directed thinking, foresight, and/or mental time travel, in conjunction with depression, depressed, or depressive. Three kinds of faulty prospection, taken together, could drive depression: Poor generation of possible futures, poor evaluation of possible futures, and negative beliefs about the future. Depressed mood and poor functioning, in turn, may maintain faulty prospection and feed a vicious cycle. Future-oriented treatment strategies drawn from cognitive-behavioural therapy help to fix poor prospection, and they deserve to be developed further. Prospection-based techniques may lead to transdiagnostic treatment strategies for depression and other disorders. © 2015 The British Psychological Society.

78 FR 42532 - Prospective Grant of Start-Up Exclusive Evaluation Option License: Methods of Treating Giardiasis...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive Evaluation Option License: Methods of Treating Giardiasis Using Available Compounds.../2013 filed April 22, 2013 (E-211- 2010/2-IN-05); each entitled ``Methods of Treating Giardiasis'' by...

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

The Science Semester: Cross-Disciplinary Inquiry for Prospective Elementary Teachers

ERIC Educational Resources Information Center

Ford, Danielle J.; Fifield, Steve; Madsen, John; Qian, Xiaoyu

2013-01-01

We describe the Science Semester, a semester-long course block that integrates three science courses and a science education methods course for elementary teacher education majors, and examine prospective elementary teachers' developing conceptions about inquiry, science teaching efficacy, and reflections on learning through inquiry. The…

Model-based choices involve prospective neural activity

PubMed Central

Doll, Bradley B.; Duncan, Katherine D.; Simon, Dylan A.; Shohamy, Daphna; Daw, Nathaniel D.

2015-01-01

Decisions may arise via “model-free” repetition of previously reinforced actions, or by “model-based” evaluation, which is widely thought to follow from prospective anticipation of action consequences using a learned map or model. While choices and neural correlates of decision variables sometimes reflect knowledge of their consequences, it remains unclear whether this actually arises from prospective evaluation. Using functional MRI and a sequential reward-learning task in which paths contained decodable object categories, we found that humans’ model-based choices were associated with neural signatures of future paths observed at decision time, suggesting a prospective mechanism for choice. Prospection also covaried with the degree of model-based influences on neural correlates of decision variables, and was inversely related to prediction error signals thought to underlie model-free learning. These results dissociate separate mechanisms underlying model-based and model-free evaluation and support the hypothesis that model-based influences on choices and neural decision variables result from prospection. PMID:25799041

Evaluation of lumbar transforaminal epidural injections with needle placement and contrast flow patterns: a prospective, descriptive report.

PubMed

Manchikanti, Laxmaiah; Cash, Kim A; Pampati, Vidyasagar; Damron, Kim S; McManus, Carla D

2004-04-01

Transforaminal epidural steroid injection is one of the commonly employed modalities of treatment in managing nerve root pain. However, there have been no controlled prospective evaluations of epidural and nerve root contrast distribution patterns and other aspects of fluoroscopically directed lumbosacral transforaminal epidural steroid injections. To evaluate contrast flow patterns and intravascular needle placement of fluoroscopically guided lumbosacral transforaminal epidural injections. A prospective, observational study. A total of 100 consecutive patients undergoing fluoroscopically guided transforaminal epidural steroid injections were evaluated. The contrast flow patterns, ventral or dorsal epidural filling, nerve root filling, C-arm time, and intravascular needle placement were evaluated. Ventral epidural filling was seen in 88% of the procedures, in contrast to dorsal filling noted in 9% of the procedures. Nerve root filling was seen in 97% of the procedures. Total intravenous placement of the needle was noted in 22% of the procedures, whereas negative flashback and aspiration was noted in 5% of the procedures. Lumbosacral transforaminal epidural injections, performed under fluoroscopic visualization, provide excellent nerve root filling and ventral epidural filling patterns. However, unrecognized intravascular needle placement with negative flashback or aspiration was noted in 5% of the procedures.

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

Dose-specific efficacy of Haemophilus influenzae type b conjugate vaccines: a systematic review and meta-analysis of controlled clinical trials

PubMed Central

GRIFFITHS, U. K.; CLARK, A.; GESSNER, B.; MINERS, A.; SANDERSON, C.; SEDYANINGSIH, E. R.; MULHOLLAND, K. E.

2012-01-01

SUMMARY Global coverage of infant Haemophilus influenzae type b (Hib) vaccination has increased considerably during the past decade, partly due to GAVI Alliance donations of the vaccine to low-income countries. In settings where large numbers of children receive only one or two vaccine doses rather than the recommended three doses, dose-specific efficacy estimates are needed to predict impact. The objective of this meta-analysis is to determine Hib vaccine efficacy against different clinical outcomes after receiving one, two or three doses of vaccine. Studies were eligible for inclusion if a prospective, controlled design had been used to evaluate commercially available Hib conjugate vaccines. Eight studies were included. Pooled vaccine efficacies against invasive Hib disease after one, two or three doses of vaccine were 59%, 92% and 93%, respectively. The meta-analysis provides robust estimates for use in decision-analytical models designed to predict the impact of Hib vaccine. PMID:22583474

Contribution to More Patient-Friendly ART Treatment: Efficacy of Continuous Low-Dose GnRH Agonist as the Only Luteal Support—Results of a Prospective, Randomized, Comparative Study

PubMed Central

Pirard, Céline; Loumaye, Ernest; Wyns, Christine

2015-01-01

Background. The aim of this pilot study was to evaluate intranasal buserelin for luteal phase support and compare its efficacy with standard vaginal progesterone in IVF/ICSI antagonist cycles. Methods. This is a prospective, randomized, open, parallel group study. Forty patients underwent ovarian hyperstimulation with human menopausal gonadotropin under pituitary inhibition with gonadotropin-releasing hormone antagonist, while ovulation trigger and luteal support were achieved using intranasal GnRH agonist (group A). Twenty patients had their cycle downregulated with buserelin and stimulated with hMG, while ovulation trigger was achieved using 10,000 IU human chorionic gonadotropin with luteal support by intravaginal progesterone (group B). Results. No difference was observed in estradiol levels. Progesterone levels on day 5 were significantly lower in group A. However, significantly higher levels of luteinizing hormone were observed in group A during the entire luteal phase. Pregnancy rates (31.4% versus 22.2%), implantation rates (22% versus 15.4%), and clinical pregnancy rates (25.7% versus 16.7%) were not statistically different between groups, although a trend towards higher rates was observed in group A. No luteal phase lasting less than 10 days was recorded in either group. Conclusion. Intranasal administration of buserelin is effective for providing luteal phase support in IVF/ICSI antagonist protocols. PMID:25945092

Efficacy of community-based multidisciplinary disease management of chronic heart failure.

PubMed

Omar, A R; Suppiah, N; Chai, P; Chan, Y H; Seow, Y H; Quek, L L; Poh, K K; Tan, H C

2007-06-01

A multidisciplinary disease management (DM) programme in chronic heart failure (CHF) improves clinical outcome. The efficacy of such a programme in a heterogeneous Asian community is not well established. Therefore, we undertook the evaluation of the efficacy of the multidisciplinary community-based DM CHF programme. This was a prospective study involving 154 patients (54 percent male) with a primary diagnosis of CHF, New York Heart Association functional class III/IV CHF, with left ventricular ejection fraction (LVEF) less than 40 percent. The mean age was 65 +/- 12 years and mean LVEF was 27 +/- 9 percent. We evaluated CHF hospitalisation, quality of life, activity status and quality of care (percentage of patients who received ACE inhibitors/angiotensin receptor blockers (ARB) and beta blockers after a period of six months. At six months, there was improvement in the quality of life and activity status (p < 0.001). ACE inhibitors/ARB were maintained in 97 percent of the patients and there was an increased usage of beta blockers (p-value equals 0.001). The rate of CHF hospitalisation was reduced by 68 percent (p-value is less than 0.001) and there was no mortality. The multidisciplinary DM of CHF in a heterogeneous Asian community showed significant improvement in quality of life, quality of care and reduction in CHF hospitalisation.

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

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

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

[Efficacy of probiotic feed additives: guidelines for the evaluation of the efficiency of microorganisms in dogs, cats, and horses].

PubMed

Lahrssen, M; Zentek, J

2002-01-01

Probiotic microorganisms are frequently in use as feed additives for farm and pet animals. For admission for the common market products have to be tested according to the feed additive directive 70/524/EC. The dossier for admission has to comprise data of efficiency as laid down in the directive 87/153/EC. During the last years it became obvious after the evaluation of several dossiers, that no definitive criteria for the assessment of efficacy were available for dogs, cats and horses (84/153/EC). Aspects like the promotion of animal production are not relevant in this context. Therefore, the European commission launched the directive for the evaluation of efficacy of microorganisms for dogs, cats and horses, that supports the evaluation of microbial feed additives and which is described in this paper.

Fluvastatin in the prevention of renal transplant vasculopathy: results of a prospective, randomized, double-blind, placebo-controlled trial.

PubMed

Serón, Daniel; Oppenheimer, Federico; Pallardó, Luis M; Lauzurica, Ricardo; Errasti, Pedro; Gomez-Huertas, Ernesto; Bosmans, Jean Louis; Sanchez-Plumed, Jaime; Romero, Rafael; Marques, María; Fulladosa, Xavier; Moreso, Francesc

2008-07-15

Statins prevent the progression of transplant vasculopathy in heart transplants, but its beneficial effect on the transplanted kidney is controversial. The aim is to evaluate the utility of fluvastatin 80 mg/day to reduce the progression of 6-month renal transplant vasculopathy in a multicenter, prospective, randomized, placebo-controlled trial stratified according to donor age. All patients received cyclosporine, mycophenolate mofetil, and prednisone. The progression of transplant vasculopathy was evaluated in paired donor and 6-month protocol biopsies. The primary efficacy variable was the progression of mean arterial intimal volume fraction (deltaVvintima/artery) evaluated with histomorphometry. The minimum sample size to detect a 50% reduction in the progression of deltaVvintima/artery was 62 patients per group. The secondary efficacy variable included the incidence of transplant vasculopathy evaluated according to Banff criteria. A total of 89 patients were included, 74 completed the 6-month study and 57 have paired biopsies with sufficient tissue for histological evaluation. The deltaVvintima/artery was not different between treatment and placebo groups (6.9+/-8.2% vs. 6.9+/-7.4%, P=ns), whereas the incidence of transplant vasculopathy was lower in the fluvastatin group (7% vs. 33%; P=0.02). Because there was a discrepancy between the primary and secondary efficacy variables, post hoc analysis was performed to evaluate the reproducibility of both variables in a subset of 50 biopsies. The reproducibility of transplant vasculopathy was higher than the reproducibility of Vvintima/artery (kappa 0.86 vs. 0.33). In summary, there were no differences in deltaVvintima/artery between groups, but fluvastatin treatment was associated with a reduced incidence of transplant vasculopathy.

Crotalidae polyvalent immune Fab (ovine) antivenom is efficacious for envenomations by Southern Pacific rattlesnakes (Crotalus helleri).

PubMed

Bush, Sean P; Green, Steven M; Moynihan, James A; Hayes, William K; Cardwell, Michael D

2002-12-01

Southern Pacific rattlesnake (Crotalus helleri ) venom is not 1 of the 4 venoms used to produce Crotalidae polyvalent immune Fab (ovine) (CroFab; FabAV). There is currently no published clinical experience regarding the efficacy of this new antivenom for confirmed C helleri envenomation, and animal data suggest greatly diminished efficacy. We assessed the efficacy of FabAV for patients with confirmed C helleri envenomation. We conducted a prospective observational study of 23 consecutive rattlesnake envenomations that were treated with FabAV at our center. Patients were excluded if the species of snake could not be confirmed, if FabAV antivenom was not given, or if Antivenin (Crotalidae) polyvalent (equine) was given. We collected serial physical examination and laboratory data over a 24-hour period to serially evaluate the severity score and performed follow-up to evaluate delayed reactions. There were 15 patients who received FabAV and had the species of rattlesnake confirmed (9 C helleri, 4 C scutulatus scutulatus, 1 C mitchellii pyrrhus, 1 C ruber ruber ). C helleri envenomations demonstrated similar improvement in serial snakebite severity scores to those of other species. Three patients treated with scheduled dosing had recurrence of progressive swelling (2 C helleri and 1 C mitchellii pyrrhus ) during the 24-hour study period. We observed similar improvement in FabAV-treated patients with C helleri envenomation compared with those of other species and conclude that this treatment in standard doses appears efficacious for bites by this species. Progressive swelling may recur despite scheduled dosing.

Prospecting for marine gas hydrate resources

USGS Publications Warehouse

Boswell, Ray; Shipp, Craig; Reichel, Thomas; Shelander, Dianna; Saeki, Tetsuo; Frye, Matthew; Shedd, William; Collett, Timothy S.; McConnell, Daniel R.

2016-01-01

As gas hydrate energy assessment matures worldwide, emphasis has evolved away from confirmation of the mere presence of gas hydrate to the more complex issue of prospecting for those specific accumulations that are viable resource targets. Gas hydrate exploration now integrates the unique pressure and temperature preconditions for gas hydrate occurrence with those concepts and practices that are the basis for conventional oil and gas exploration. We have aimed to assimilate the lessons learned to date in global gas hydrate exploration to outline a generalized prospecting approach as follows: (1) use existing well and geophysical data to delineate the gas hydrate stability zone (GHSZ), (2) identify and evaluate potential direct indications of hydrate occurrence through evaluation of interval of elevated acoustic velocity and/or seismic events of prospective amplitude and polarity, (3) mitigate geologic risk via regional seismic and stratigraphic facies analysis as well as seismic mapping of amplitude distribution along prospective horizons, and (4) mitigate further prospect risk through assessment of the evidence of gas presence and migration into the GHSZ. Although a wide range of occurrence types might ultimately become viable energy supply options, this approach, which has been tested in only a small number of locations worldwide, has directed prospect evaluation toward those sand-hosted, high-saturation occurrences that were presently considered to have the greatest future commercial potential.

Longitudinal Relationship between Self-efficacy and Posttraumatic Stress Symptoms 8 Years after a Violent Assault: An Autoregressive Cross-Lagged Model.

PubMed

Nygaard, Egil; Johansen, Venke A; Siqveland, Johan; Hussain, Ajmal; Heir, Trond

2017-01-01

Self-efficacy is assumed to promote posttraumatic adaption, and several cross-sectional studies support this notion. However, there is a lack of prospective longitudinal studies to further illuminate the temporal relationship between self-efficacy and posttraumatic stress symptoms. Thus, an important unresolved research question is whether posttraumatic stress disorder (PTSD) symptoms affect the level of self-efficacy or vice versa or whether they mutually influence each other. The present prospective longitudinal study investigated the reciprocal relationship between general self-efficacy (GSE) and posttraumatic stress symptoms in 143 physical assault victims. We used an autoregressive cross-lagged model across four assessment waves: within 4 months after the assault (T1) and then 3 months (T2), 12 months (T3) and 8 years (T4) after the first assessment. Stress symptoms at T1 and T2 predicted subsequent self-efficacy, while self-efficacy at T1 and T2 was not related to subsequent stress symptoms. These relationships were reversed after T3; higher levels of self-efficacy at T3 predicted lower levels of posttraumatic stress symptoms at T4, while posttraumatic tress symptoms at T3 did not predict self-efficacy at T4. In conclusion, posttraumatic stress symptoms may have a deteriorating effect on self-efficacy in the early phase after physical assault, whereas self-efficacy may promote recovery from posttraumatic stress symptoms over the long term.

Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): A prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease

PubMed Central

Ripley, David P.; Brown, Julia M.; Everett, Colin C.; Bijsterveld, Petra; Walker, Simon; Sculpher, Mark; McCann, Gerry P.; Berry, Colin; Plein, Sven; Greenwood, John P.

2015-01-01

Background A number of investigative strategies exist for the diagnosis of coronary heart disease (CHD). Despite the widespread availability of noninvasive imaging, invasive angiography is commonly used early in the diagnostic pathway. Consequently, approximately 60% of angiograms reveal no evidence of obstructive coronary disease. Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk. There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance. Trial Design CE-MARC 2 is a prospective, multicenter, 3-arm parallel group, randomized controlled trial of patients with suspected CHD (pretest likelihood 10%-90%) requiring further investigation. A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance–guided care, single-photon emission computed tomography–guided care (according to American College of Cardiology/American Heart Association appropriate-use criteria), or National Institute for Health and Care Excellence guidelines–based management. The primary (efficacy) end point is the occurrence of unnecessary angiography as defined by a normal (>0.8) invasive fractional flow reserve. Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates. Cost-effectiveness and health-related quality-of-life measures will be performed. Conclusions The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD, with the intension of reducing unnecessary invasive angiography rates. Evaluation of these management strategies has the potential to improve patient care, health-related quality of life, and the cost-effectiveness of CHD investigation. PMID:25497243

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.

Study design of J-ELD AF: A multicenter prospective cohort study to investigate the efficacy and safety of apixaban in Japanese elderly patients.

PubMed

Akao, Masaharu; Yamashita, Takeshi; Okumura, Ken

2016-12-01

Apixaban, one of the non-vitamin K antagonist oral anticoagulants, was reported to be effective and safe in stroke prevention in patients with atrial fibrillation (AF) based on the global randomized clinical trial, but data are limited on the efficacy and safety of apixaban in Japanese elderly patients. The J-ELD AF Registry is a large-scale, contemporary observational study, continuously and prospectively registering elderly Japanese patients with AF aged 75 years or older who are currently taking apixaban or the elderly who are to receive apixaban in daily clinical practice, and accumulating the outcomes during one-year follow-up period. In addition to standard baseline characteristics, prothrombin time and anti-Xa activity will be measured to investigate the biomarker characteristics. The primary efficacy endpoints will be stroke and systemic embolism, and the primary safety endpoint will be major bleeding requiring hospitalization. The secondary endpoints in this study will be all-cause death, cardiovascular death, acute myocardial infarction, and the composite of stroke/systemic embolism, cardiovascular death, and acute myocardial infarction. As a primary analysis, the primary/secondary endpoints in the enrolled patients will be totalized for the entire group, and the incidence of events will be described by age, CHADS 2 score, HAS-BLED score, and apixaban dose (5 or 2.5mg bid). The factors that independently predict the incidence of the primary/secondary endpoints will be searched for by Cox regression. The relationship between the biomarkers and the primary/secondary endpoints will also be examined in an explorative manner. This study will provide important information on the efficacy and safety of apixaban in elderly Japanese patients aged 75 years or older, and those of low-dose administration of apixaban (2.5mg bid) for which many of the Japanese elderly are indicated. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights

Efficacy of topical resin lacquer, amorolfine and oral terbinafine for treating toenail onychomycosis: a prospective, randomized, controlled, investigator-blinded, parallel-group clinical trial.

PubMed

Auvinen, T; Tiihonen, R; Soini, M; Wangel, M; Sipponen, A; Jokinen, J J

2015-10-01

Norway spruce (Picea abies) produces resin to protect against decomposition by microbial pathogens. In vitro tests have shown that spruce resin has antifungal properties against dermatophytes known to cause nearly 90% of onychomycosis in humans. To confirm previous in vivo observations that a topical resin lacquer provides mycological and clinical efficacy, and to compare this lacquer with topical amorolfine hydrochloride lacquer and systemic terbinafine for treating dermatophyte toenail onychomycosis. In this prospective, randomized, controlled, investigator-blinded study, 73 patients with onychomycosis were randomized to receive topical 30% resin lacquer once daily for 9 months, topical 5% amorolfine lacquer once weekly for 9 months, or 250 mg oral terbinafine once daily for 3 months. The primary outcome measure was complete mycological cure at 10 months. Secondary outcomes were clinical efficacy, cost-effectiveness and patient compliance. At 10 months, complete mycological cure rates with the resin, amorolfine and terbinafine treatments were 13% [95% confidence interval (CI) 0-28], 8% (95% CI 0-19) and 56% (95% CI 35-77), respectively (P ≤ 0·002). At 10 months, clinical responses were complete in four patients (16%) treated with terbinafine, and partial in seven (30%), seven (28%) and nine (36%) patients treated with resin, amorolfine and terbinafine, respectively (P < 0·05). Resin, amorolfine and terbinafine treatments cost €41·6, €56·3 and €52·1, respectively, per patient (P < 0·001). Topical 30% resin lacquer and topical 5% amorolfine lacquer provided similar efficacy for treating dermatophyte toenail onychomycosis. However, orally administered terbinafine was significantly more effective in terms of mycological cure and clinical outcome than either topical therapy at the 10-month follow-up. © 2015 British Association of Dermatologists.

A prospective, randomized pilot study on the safety and efficacy of recombinant human growth and differentiation factor-5 coated onto β-tricalcium phosphate for sinus lift augmentation.

PubMed

Koch, Felix P; Becker, Jürgen; Terheyden, Hendrik; Capsius, Björn; Wagner, Wilfried

2010-11-01

The aim of this prospective, randomized clinical trial was to investigate the potential of recombinant human growth and differentiation factor-5 (rhGDF-5) coated onto β-tricalcium phosphate (β-TCP) (rhGDF-5/β-TCP) to support bone formation after sinus lift augmentation. In total, 31 patients participated in this multicenter clinical trial. They required a two-stage unilateral maxillary sinus floor augmentation (residual bone height <5 mm). According to a parallel-group design, the patients were randomized to three treatment groups: (a) augmentation with rhGDF-5/β-TCP and a 3-month healing period, (b) augmentation with rhGDF-5/β-TCP and a 4-month healing period and (c) medical device β-TCP mixed with autologous bone and a 4-month healing period. The primary study objective was the area of newly formed bone within the augmented area as assessed by histomorphometric evaluation of trephine bur biopsies. The osseous regeneration was similar in each treatment group; the amount of newly formed bone ranged between 28% (± 15.5%) and 31.8% (± 17.9%). Detailed analysis of histological data will be published elsewhere. As secondary efficacy variables, the augmentation height at the surgery site was measured by radiography. The largest augmentation was radiologically achieved in the rhGDF-5/β-TCP - 3-month and the rhGDF-5/β-TCP - 4-month treatment groups. As safety parameters, adverse events were recorded and anti-drug antibody levels were evaluated. Most of the adverse events were judged as unrelated to the study medication. Four out of 47 (8.5%) implants failed in patients treated with rhGDF-5/β-TCP, a result that is in agreement with the general implant failure rate of 5-15%. Transiently very low amounts of anti-rhGDF-5 antibodies were detected in some patients who received rhGDF-5, which was not related to the bone formation outcome. rhGDF-5/β-TCP was found to be effective and safe as the control treatment with autologous bone mixed β-TCP in sinus floor

[Efficacy and safety of deferasirox in aplastic anemia patients with iron overload: a single arm, multi-center,prospective study in China].

PubMed

Shi, Jun; Chang, Hong; Zhang, Li; Shao, Yinqi; Nie, Neng; Zhang, Jing; Huang, Jinbo; Zhang, Li; Tang, Xudong; Quan, Richeng; Zheng, Chunmei; Xiao, Haiyan; Hu, Dengming; Hu, Lingyan; Liu, Feng; Zhou, Yongming; Zheng, Yizhou; Zhang, Fengkui

2016-01-01

To explore the efficacy and safety of deferasirox in aplastic anemia (AA)patients with iron overload. A single arm, multi- center, prospective, open- label study was conducted to evaluate absolute change in serum ferritin (SF)from baseline to 12 months of deferasirox administration, initially at a dose of 20 mg·kg(-1)·d(-1), and the safety in 64 AA patients with iron overload. All patients started their deferasirox treatment with a daily dose of 20 mg · kg(-1) ·d(-1). The mean actual dose was (18.6±3.60) mg · kg(-1)·d(-1). The median SF decreased from 4 924 (2 718- 6 765)μg/L at baseline (n=64) to 3 036 (1 474- 5 551)μg/L at 12 months (n=23) with the percentage change from baseline as 38%. A median SF decrease of 651 (126-2 125)μg/L was observed at the end of study in 23 patients who completed 12 months' treatment, the median SF level decreased by 1 167(580-4 806)μg/L [5 271(3 420-8 278)μg/L at baseline; 3 036(1 474-5 551)μg/L after 12 months' treatment; the percentage change from baseline as 42% ] after 12 months of deferasirox treatment. The most common adverse events (AEs) were increased serum creatinine levels (40.98%), gastrointestinal discomfort (40.98%), elevated liver transaminase (ALT: 21.31%; AST: 13.11%)and proteinuria (24.59%). The increased serum creatinine levels were reversible and non-progressive. Of 38 patients with concomitant cyclosporine use, 12(31.8%)patients had two consecutive values >ULN, 10(26.3%)patients had two consecutive values >1.33 baseline values, but only 1(2.6%)patient's serum creatinine increased more than 1.33 baseline values and exceeded ULN. For both AST and ALT, no patients experienced two post- baseline values >5 ×ULN or >10 × ULN during the whole study. In AA patients with low baseline PLT count (less than 50 × 10(9)/L), there was no decrease for median PLT level during 12 months' treatment period. AA patients with iron overload could achieve satisfactory efficacy of iron chelation by deferasirox treatment

Changes in Self-Efficacy of Prospective Special and General Education Teachers: Implication for Inclusive Education

ERIC Educational Resources Information Center

Leyser, Yona; Zeiger, Tali; Romi, Shlomo

2011-01-01

The impact of three variables on the self-efficacy of 992 general and special education preservice teachers was examined. These variables were years of preservice education, experience with children with special educational needs, and training in inclusion or exceptional education. All participants responded to a teacher self-efficacy scale that…

Measuring Practicing and Prospective Elementary Teachers' Efficacy for Classroom Management: A Preliminary Development and Validation Study

ERIC Educational Resources Information Center

Putman, S. Michael

2013-01-01

Research has shown efficacy exerts a powerful influence on behavior. Classroom management represents one vehicle for demonstrations of these behaviors, yet few instruments focus solely on the measurement of this domain-specific form of efficacy. This research explored the relationship between teacher self-efficacy and classroom management through…

Preliminary evidence that self-efficacy predicts physical activity in multiple sclerosis.

PubMed

Motl, Robert W; McAuley, Edward; Doerksen, Shawna; Hu, Liang; Morris, Katherine S

2009-09-01

Individuals with multiple sclerosis (MS) are less physically active than non diseased people. One method for increasing physical activity levels involves the identification of factors that correlate with physical activity and that are modifiable by a well designed intervention. This study examined two types of self-efficacy as cross-sectional and prospective correlates of objectively measured physical activity in 16 individuals with a diagnosis of MS. The participants completed two measures of self-efficacy and then wore an accelerometer for a 5-day period at baseline and then at 3 months follow-up. Self-efficacy for continued physical activity was associated with baseline and follow-up levels of physical activity. Self-efficacy for overcoming barriers was associated with follow-up levels of physical activity and change in physical activity across a 3-month period. Researchers should consider self-efficacy as a possible component of an intervention that is designed to increase physical activity levels in those with MS. International Journal of Rehabilitation Research

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

Evaluation of the efficacy of photodynamic therapy for the treatment of actinic cheilitis.

PubMed

Chaves, Yuri N; Torezan, Luis Antonio; Lourenço, Silvia Vanessa; Neto, Cyro Festa

2017-01-01

Actinic cheilitis (AC) is a lip intraepithelial neoplasia, whose cells present alterations similar to those presented by invasive squamous cell carcinomas (SCCs). To conduct clinical and laboratory evaluation by histopathology and immunohistochemistry of the efficacy of actinic cheilitis treatment using photodynamic therapy (PDT) with methyl aminolevulinate (MAL) and noncoherent red light. Patients with actinic cheilitis detected by histopathological examination were submitted to two sessions of photodynamic therapy with a two-week interval between them. They were examined immediately after the sessions, four, six, and twelve weeks after beginning treatment when a new biopsy was carried out. Clinical histopathological and immunohistochemical parameters were evaluated before and after treatment. Of the 23 patients who underwent biopsy, 16 completed two photodynamic therapy sessions and the material of one patient was insufficient for immunohistochemistry. Complete clinical response was achieved in 62.5% (10 of 16 patients) and 37.5% still remained with clinical evidence of AC. In spite of this, no case of cure by histopathological analysis was found. There was no significant statistical change among the values of Ki-67, survivin, and p53 observed before and after treatment. Photodynamic therapy, as carried out in this trial, was not an efficacious therapeutic option for treating patients with actinic cheilitis included in this sample. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons 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.

Treatment of lymphangiomas with OK-432 (Picibanil) sclerotherapy: a prospective multi-institutional trial.

PubMed

Giguère, Chantal M; Bauman, Nancy M; Sato, Yutaka; Burke, Diane K; Greinwald, John H; Pransky, Seth; Kelley, Peggy; Georgeson, Keith; Smith, Richard J H

2002-10-01

To describe and to determine the robustness of our study evaluating the efficacy of OK-432 (Picibanil) as a therapeutic modality for lymphangiomas. Prospective, randomized trial and parallel-case series at 13 US tertiary care referral centers. Thirty patients diagnosed as having lymphangioma. Ages in 25 ranged from 6 months to 18 years. Twenty-nine had lesions located in the head-and-neck area. Every patient received a 4-dose injection series of OK-432 scheduled 6 to 8 weeks apart unless a contraindication existed or a complete response was observed before completion of all injections. A control group was observed for 6 months. Successful outcome of therapy was defined as a complete or a substantial (>60%) reduction in lymphangioma size as determined by calculated lesion volumes on computed tomographic or magnetic resonance imaging scans. Overall, 19 (86%) of the 22 patients with predominantly macrocystic lymphangiomas had a successful outcome. OK-432 should be efficacious in the treatment of lymphangiomas. Our study design is well structured to clearly define the role of this treatment agent.

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.

48 CFR 253.209-1 - Responsible prospective contractors.

Code of Federal Regulations, 2010 CFR

2010-10-01

... required service. (B) Production capability. An evaluation of the prospective contractor's ability to plan.... (C) Quality assurance capability. An assessment of the prospective contractor's capability to meet the quality assurance requirements of the proposed contract. It may involve an evaluation of the...

Fractionated bipolar radiofrequency and bipolar radiofrequency potentiated by infrared light for treating striae: A prospective randomized, comparative trial with objective evaluation.

PubMed

Harmelin, Yona; Boineau, Dominique; Cardot-Leccia, Nathalie; Fontas, Eric; Bahadoran, Philippe; Becker, Anne-Lise; Montaudié, Henri; Castela, Emeline; Perrin, Christophe; Lacour, Jean-Philippe; Passeron, Thierry

2016-03-01

Very few treatments for striae are based on prospective randomized trials. The objective of this study was to assess the efficacy of bipolar fractional radiofrequency and bipolar radiofrequency potentiated with infrared light, alone or combined, for treating abdominal stretch marks. Bicentric prospective interventional randomized controlled trial in the department of Dermatology of University Hospital of Nice and Aesthetics Laser Center of Bordeaux, France. Men and women of age 18 years or above, who presented for the treatment of mature or immature abdominal striae were included. The patients' abdomens were divided into four equal quadrants. Bipolar radiofrequency potentiated with infrared light and fractional bipolar radiofrequency were applied, alone or combined, and compared to the remaining untreated quadrant. The main criterion of evaluation was the measurement of depth of striae, using 3D photography at 6 months follow-up. A global assessment was also rated by the physician performing the treatment and by the patients. Histological analysis and confocal laser microscopy were additionally performed. A total of 22 patients were enrolled, and 384 striae were measured. In per protocol analysis mean striae depth was decreased by 21.64%, observed at 6 months follow-up with the combined approach, compared to an increase of 1.73% in the control group (P < 0.0001). No significant difference in striae width was observed between the treated or control quadrants. Global assessment by the physician who performed the treatment and by the patient both showed greater improved with the combination treatment compared to control areas (P = 0.004 and P = 0.01, respectively). A more homogeneous interlacing pattern and thicker collagen fibers with a decreased proportion of elastic fibers was observed after treatment. Fractional bipolar radiofrequency, combined with bipolar radiofrequency potentiated by infrared light, is an effective treatment of both immature and

Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

PubMed

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

2011-07-01

The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001). In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

Characteristics of a multisensor system for non invasive glucose monitoring with external validation and prospective evaluation.

PubMed

Caduff, Andreas; Mueller, Martin; Megej, Alexander; Dewarrat, Francois; Suri, Roland E; Klisic, Jelena; Donath, Marc; Zakharov, Pavel; Schaub, Dominik; Stahel, Werner A; Talary, Mark S

2011-05-15

The Multisensor Glucose Monitoring System (MGMS) features non invasive sensors for dielectric characterisation of the skin and underlying tissue in a wide frequency range (1 kHz-100 MHz, 1 and 2 GHz) as well as optical characterisation. In this paper we describe the results of using an MGMS in a miniaturised housing with fully integrated sensors and battery. Six patients with Type I Diabetes Mellitus (age 44±16 y; BMI 24.1±1.3 kg/m(2), duration of diabetes 27±12 y; HbA1c 7.3±1.0%) wore a single Multisensor at the upper arm position and performed a total of 45 in-clinic study days with 7 study days per patient on average (min. 5 and max. 10). Glucose changes were induced either orally or by i.v. glucose administration and the blood glucose was measured routinely. Several prospective data evaluation routines were applied to evaluate the data. The results are shown using one of the restrictive data evaluation routines, where measurements from the first 22 study days were used to train a linear regression model. The global model was then prospectively applied to the data of the remaining 23 study days to allow for an external validation of glucose prediction. The model application yielded a Mean Absolute Relative Difference of 40.8%, a Mean Absolute Difference of 51.9 mg dL(-1), and a correlation of 0.84 on average per study day. The Clarke error grid analyses showed 89.0% in A+B, 4.5% in C, 4.6% in D and 1.9% in the E region. Prospective application of a global, purely statistical model, demonstrates that glucose variations can be tracked non invasively by the MGMS in most cases under these conditions. Copyright © 2011 Elsevier B.V. All rights reserved.

Efficacy of oral moxifloxacin for aerobic vaginitis.

PubMed

Wang, C; Han, C; Geng, N; Fan, A; Wang, Y; Yue, Y; Zhang, H; Xue, F

2016-01-01

The purpose of this study was to investigate the therapeutic efficacy of oral moxifloxacin for aerobic vaginitis (AV). We also identified factors that are associated with therapeutic efficacy. This prospective study enrolled general gynecological outpatients at Tianjin Medical University General Hospital between September 2012 and May 2014. Women diagnosed with AV (n = 102) were recruited. All enrolled women were treated with oral moxifloxacin, 400 mg once daily for 6 days (one course). Therapeutic efficacy was evaluated based on microscopic criteria, and cure rates were calculated. Women who were microscopically improved (but not cured) received a second course of therapy. Women classified with microscopic failure were treated using other strategies. Univariate and multivariate logistic regression analysis was used to identify factors that may be associated with a cure after one course of therapy. After one course of therapy, 65.7 % (67/102) of women were cured, 29.4 % (30/102) of women were improved (but not cured), 4.9 % (5/102) of women failed to respond to the therapy. After two courses of therapy, 85.3 % (87/102) of women were cured, 9.8 % (10/102) of women were improved, 4.9 % (5/102) of women failed to respond to the therapy, and clinical improvement was achieved in additional women. In the multivariate logistic regression analysis, women with a baseline vaginal pH value of <5.0 had a 3.5-times higher chance of being cured, compared with those with a baseline vaginal pH value of ≥5.0 (OR, 3.503; 95 % CI, 1.278-9.601). Moxifloxacin is an effective therapeutic option for patients with AV. Most women with AV were cured with one course of moxifloxacin. For those with a higher vaginal pH value of ≥5.0 before treatment, two courses of therapy should be considered.

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

Prospective Randomized Controlled Study on the Efficacy of Multimedia Informed Consent for Patients Scheduled to Undergo Green-Light High-Performance System Photoselective Vaporization of the Prostate

PubMed Central

Ham, Dong Yeub; Choi, Woo Suk; Song, Sang Hoon; Ahn, Young-Joon; Park, Hyoung Keun; Kim, Hyeong Gon

2016-01-01

Purpose The aim of this study was to evaluate the efficacy of a multimedia informed consent (IC) presentation on the understanding and satisfaction of patients who were scheduled to receive 120-W green-light high-performance system photoselective vaporization of the prostate (HPS-PVP). Materials and Methods A multimedia IC (M-IC) presentation for HPS-PVP was developed. Forty men with benign prostatic hyperplasia who were scheduled to undergo HPS-PVP were prospectively randomized to a conventional written IC group (W-IC group, n=20) or the M-IC group (n=20). The allocated IC was obtained by one certified urologist, followed by a 15-question test (maximum score, 15) to evaluate objective understanding, and questionnaires on subjective understanding (range, 0~10) and satisfaction (range, 0~10) using a visual analogue scale. Results Demographic characteristics, including age and the highest level of education, did not significantly differ between the two groups. No significant differences were found in scores reflecting the objective understanding of HPS-PVP (9.9±2.3 vs. 10.6±2.8, p=0.332) or in subjective understanding scores (7.5±2.1 vs. 8.6±1.7, p=0.122); however, the M-IC group showed higher satisfaction scores than the W-IC group (7.4±1.7 vs. 8.4±1.5, p=0.033). After adjusting for age and educational level, the M-IC group still had significantly higher satisfaction scores. Conclusions M-IC did not enhance the objective knowledge of patients regarding this surgical procedure. However, it improved the satisfaction of patients with the IC process itself. PMID:27169129

Efficacy of mesotherapy in facial rejuvenation: a histological and immunohistochemical evaluation

PubMed Central

El-Domyati, Moetaz; El-Ammawi, Tarek S.; Moawad, Osama; El-Fakahany, Hasan; Medhat, Walid; Mahoney, Mỹ G.; Uitto, Jouni

2012-01-01

Background Mesotherapy, commonly known as “biorejuvenation” or “biorevitalization”, is a technique used to rejuvenate the skin by means of a transdermal injection of a multivitamin solution and natural plant extracts that are thought to improve the signs of skin aging. Objectives This prospective study aimed to evaluate the clinical effect of mesotherapy applied to periorbital wrinkles and to quantitatively evaluate histological changes in the skin occurring in response to the same treatment. Methods Six volunteers with Fitzpatrick skin types III or IV and Glogau class I–III wrinkles were subjected to a three-month course of mesotherapy injections in the periocular area (six sessions administered at two-week intervals). Standard photographs and skin biopsies were obtained from the treatment area at baseline, at the end of treatment, and at three months post-treatment. Quantitative evaluation of collagen types I, III, and VII, newly synthesized collagen, total elastin, and tropoelastin was performed using a computerized morphometric analysis. Results The clinical evaluation of volunteers at baseline, end of treatment, and three months post-treatment revealed no significant differences. Histological and immunostaining analysis of collagen types I, III, and VII, newly synthesized collagen, total elastin, and tropoelastin showed no statistically significant changes (P > 0.05) after mesotherapy injection. Conclusions The present study indicates that mesotherapy for skin rejuvenation does not result in statistically significant histological changes or clinical improvement. PMID:22788806

Efficacy and safety of darunavir (Prezista®) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study

PubMed Central

Benea, Otilia Elisabeta; Streinu-Cercel, Adrian; Dorobăţ, Carmen; Rugină, Sorin; Negruţiu, Lucian; Cupşa, Augustin; Duiculescu, Dan; Chiriac, Carmen; Itu, Corina; Prisăcariu, Liviu Jany; Iosif, Ionel

2014-01-01

Introduction The aim of the study was to assess the safety and efficacy of darunavir (Prezista®) used in subtype F human immunodeficiency virus – type 1 (HIV-1) infected, antiretroviral therapy (ART)-experienced patients in Romania in routine clinical practice. Methods This was a post-authorization, open-label, one-cohort, non-interventional, prospective study conducted at multiple sites in Romania to assess efficacy (CD4 cell count, viral load, and treatment compliance) and safety ([serious] adverse events, clinical laboratory evaluation, and vital signs) of darunavir in combination with low-dose ritonavir (DRV/r) and other antiretroviral (ARV) medications in subtype F HIV-1 infected subjects in naturalistic settings. Seventy-eight subjects were recruited by 9 investigational sites and received 600/100 mg DRV/r twice daily. Results Treatment with DRV/r administered with other ARV medications resulted in the expected, statistically relevant improvement of CD4 cell count and viral load in subjects eligible for such treatment. In addition, adherence to treatment was high and the treatment-emergent safety profile observed during this study was consistent with the established safety profile of darunavir. Conclusion DRV/r administered in combination with other ARV medications in subtype F HIV-1 infected subjects in naturalistic settings proved to be an effective and safe treatment in Romania. Trial registration NCT01253967 PMID:25276665

The long-term efficacy of hydrocele treatment with aspiration and sclerotherapy with polidocanol compared to placebo: a prospective, double-blind, randomized study.

PubMed

Lund, L; Kloster, A; Cao, T

2014-05-01

We evaluate whether aspiration and sclerosing of hydrocele testis is an effective treatment. Men with symptomatic hydrocele testis were included in this prospective, double-blind, randomized study with polidocanol and placebo. Patients were randomized to active treatment or placebo at the first treatment. Depending on hydrocele testis size (less than 100, 100 to 200 and greater than 200 ml), the patients were treated with 1, 3 or 4 ml polidocanol after aspiration. Patients with recurrence at the 5-week followup received active treatment. A total of 77 patients were included in the study. In group 1 (active treatment) there were 36 patients with a median age of 63 years (range 34 to 92). In group 2, comprised of 41 patients, the median age was 59 years (range 26 to 82). Median followup was 72 months. A significant difference between the groups was observed after the first and second treatments. Recurrence after the first treatment was seen in 16 (44%) patients from group 1 and in 32 (78%) from group 2 (p <0.05). Recurrence after re-treatment with the active drug in both groups was seen in 4 (25%) patients in group 1 and in 14 (44%) in the former placebo group (p <0.05). The overall success rate of treatment in the active group was 89%. There was no difference between the 2 groups in terms of volume of fluid aspirated, symptoms or complications. This long-term efficacy randomized study with placebo showed that polidocanol is effective for the treatment of hydrocele testis with a low recurrence rate. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Longitudinal Relationship between Self-efficacy and Posttraumatic Stress Symptoms 8 Years after a Violent Assault: An Autoregressive Cross-Lagged Model

PubMed Central

Nygaard, Egil; Johansen, Venke A.; Siqveland, Johan; Hussain, Ajmal; Heir, Trond

2017-01-01

Self-efficacy is assumed to promote posttraumatic adaption, and several cross-sectional studies support this notion. However, there is a lack of prospective longitudinal studies to further illuminate the temporal relationship between self-efficacy and posttraumatic stress symptoms. Thus, an important unresolved research question is whether posttraumatic stress disorder (PTSD) symptoms affect the level of self-efficacy or vice versa or whether they mutually influence each other. The present prospective longitudinal study investigated the reciprocal relationship between general self-efficacy (GSE) and posttraumatic stress symptoms in 143 physical assault victims. We used an autoregressive cross-lagged model across four assessment waves: within 4 months after the assault (T1) and then 3 months (T2), 12 months (T3) and 8 years (T4) after the first assessment. Stress symptoms at T1 and T2 predicted subsequent self-efficacy, while self-efficacy at T1 and T2 was not related to subsequent stress symptoms. These relationships were reversed after T3; higher levels of self-efficacy at T3 predicted lower levels of posttraumatic stress symptoms at T4, while posttraumatic tress symptoms at T3 did not predict self-efficacy at T4. In conclusion, posttraumatic stress symptoms may have a deteriorating effect on self-efficacy in the early phase after physical assault, whereas self-efficacy may promote recovery from posttraumatic stress symptoms over the long term. PMID:28620334

Clinical Efficacy of Intravenous Lidocaine for Thyroidectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Choi, Geun Joo; Kang, Hyun; Ahn, Eun Jin; Oh, Jong In; Baek, Chong Wha; Jung, Yong Hun; Kim, Jin Yun

2016-12-01

Systemic lidocaine has analgesic and anti-inflammatory effects. The purpose of this prospective, randomized, double-blind study was to evaluate the effects of intravenous lidocaine on pain following thyroidectomy. Fifty-eight adult patients scheduled for total thyroidectomy were randomly allocated to receive a 1.5 mg/kg lidocaine bolus followed by a 2 mg/kg/h infusion during surgery, or the same volume of normal saline (control). After thyroidectomy, we evaluated postoperative pain, nausea, fentanyl consumption, frequency of pushing the button (FPB) for patient-controlled analgesia (PCA), High-sensitivity C-reactive protein (hs-CRP) in serum, and patient satisfaction scores regarding the recovery process. Postoperative pain and nausea scores were significantly lower in the lidocaine group for the first 4 h following thyroidectomy, compared to the control group. Fentanyl consumption and FPB for the PCA were also significantly reduced in the lidocaine group for 4 h following thyroidectomy, and hs-CRP was significantly less in the lidocaine group at postoperative days 1 and 3. Furthermore, satisfaction scores were significantly higher in the lidocaine group compared to the control group. Intravenous lidocaine effectively reduced postoperative pain and nausea following thyroidectomy as well as improved the quality of recovery. Clinicaltrials.gov NCT01608360.

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…

Morning Self-Efficacy Predicts Physical Activity Throughout the Day in Knee Osteoarthritis

PubMed Central

Zhaoyang, Ruixue; Martire, Lynn M.; Sliwinski, Martin J.

2017-01-01

Objective The purpose of this study was to examine the within-day and cross-day prospective effects of knee osteoarthritis (OA) patients’ self-efficacy to engage in physical activity despite the pain on their subsequent physical activity assessed objectively in their natural environment. Methods Over 22 days, 135 older adults with knee OA reported their morning self-efficacy for being physically active throughout the day using a handheld computer and wore an accelerometer to measure moderate activity and steps. Results Morning self-efficacy had a significant positive effect on steps and moderate-intensity activity throughout that day, above and beyond the effects of demographic background and other psychosocial factors as well as spouses’ support and social control. The lagged effect of morning self-efficacy on the next day’s physical activity and the reciprocal lagged effect of physical activity on the next day’s self-efficacy were not significant. Positive between-person effects of self-efficacy on physical activity were found. Conclusions Future research should aim to better understand the mechanisms underlying fluctuations in patients’ daily self-efficacy, and target patients’ daily self-efficacy as a modifiable psychological mechanism for promoting physical activity. PMID:28277696

Morning self-efficacy predicts physical activity throughout the day in knee osteoarthritis.

PubMed

Zhaoyang, Ruixue; Martire, Lynn M; Sliwinski, Martin J

2017-06-01

The purpose of this study was to examine the within-day and cross-day prospective effects of knee osteoarthritis (OA) patients' self-efficacy to engage in physical activity despite the pain on their subsequent physical activity assessed objectively in their natural environment. Over 22 days, 135 older adults with knee OA reported their morning self-efficacy for being physically active throughout the day using a handheld computer and wore an accelerometer to measure moderate activity and steps. Morning self-efficacy had a significant positive effect on steps and moderate-intensity activity throughout that day, above and beyond the effects of demographic background and other psychosocial factors as well as spouses' support and social control. The lagged effect of morning self-efficacy on the next day's physical activity and the reciprocal lagged effect of physical activity on the next day's self-efficacy were not significant. Positive between-person effects of self-efficacy on physical activity were found. Future research should aim to better understand the mechanisms underlying fluctuations in patients' daily self-efficacy, and target patients' daily self-efficacy as a modifiable psychological mechanism for promoting physical activity. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Ictal and interictal electric source imaging in presurgical evaluation: a prospective study.

PubMed

Sharma, Praveen; Scherg, Michael; Pinborg, Lars H; Fabricius, Martin; Rubboli, Guido; Pedersen, Birthe; Leffers, Anne-Mette; Uldall, Peter; Jespersen, Bo; Brennum, Jannick; Mølby Henriksen, Otto; Beniczky, Sándor

2018-05-11

Accurate localization of the epileptic focus is essential for surgical treatment of patients with drug- resistant epilepsy. EEG source imaging (ESI) is increasingly used in presurgical evaluation. However, most previous studies analysed interictal discharges. Prospective studies comparing feasibility and accuracy of interictal (II) and ictal (IC) ESI are lacking. We prospectively analysed long-term video EEG recordings (LTM) of patients admitted for presurgical evaluation. We performed ESI of II and IC signals, using two methods: equivalent current dipole (ECD) and distributed source model (DSM). LTM recordings employed the standard 25-electrode array (including inferior temporal electrodes). An age-matched template head-model was used for source analysis. Results were compared with intracranial recordings (ICR), conventional neuroimaging methods (MRI, PET, SPECT) and outcome one year after surgery. Eighty-seven consecutive patients were analysed. ECD gave a significantly higher proportion of patients with localised focal abnormalities (94%) compared to MRI (70%), PET (66%) and SPECT (64%). Agreement between the ESI methods and ICR was moderate to substantial (k=0.56-0.79). Fifty-four patients were operated (47 for more than one year ago) and 62% of them became seizure-free. Localization accuracy of II-ESI was 51% for DSM and 57% for ECD; for IC-ESI this was 51% (DSM) and 62% (ECD). The differences between the ESI methods were not significant. Differences in localization accuracy between ESI and MRI (55%), PET (33%) and SPECT (40%) were not significant. II and IC ESI of LTM-data have high feasibility and their localisation accuracy is similar to the conventional neuroimaging methods. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Evaluating the efficacies of Maximum Tolerated Dose and metronomic chemotherapies: A mathematical approach

NASA Astrophysics Data System (ADS)

Guiraldello, Rafael T.; Martins, Marcelo L.; Mancera, Paulo F. A.

2016-08-01

We present a mathematical model based on partial differential equations that is applied to understand tumor development and its response to chemotherapy. Our primary aim is to evaluate comparatively the efficacies of two chemotherapeutic protocols, Maximum Tolerated Dose (MTD) and metronomic, as well as two methods of drug delivery. Concerning therapeutic outcomes, the metronomic protocol proves more effective in prolonging the patient's life than MTD. Moreover, a uniform drug delivery method combined with the metronomic protocol is the most efficient strategy to reduce tumor density.

Prospective evaluation of the fetal heart using Fetal Intelligent Navigation Echocardiography (FINE).

PubMed

Garcia, M; Yeo, L; Romero, R; Haggerty, D; Giardina, I; Hassan, S S; Chaiworapongsa, T; Hernandez-Andrade, E

2016-04-01

To evaluate prospectively the performance of Fetal Intelligent Navigation Echocardiography (FINE) applied to spatiotemporal image correlation (STIC) volume datasets of the normal fetal heart. In all women between 19 and 30 weeks' gestation with a normal fetal heart, an attempt was made to acquire STIC volume datasets of the apical four-chamber view if the following criteria were met: (1) fetal spine located between 5- and 7-o'clock positions; (2) minimal or absent shadowing (including a clearly visible transverse aortic arch); (3) absence of fetal breathing, hiccups, or movement; and (4) adequate image quality. Each STIC volume successfully acquired was evaluated by STICLoop™ to determine its appropriateness before applying the FINE method. Visualization rates of fetal echocardiography views using diagnostic planes and/or Virtual Intelligent Sonographer Assistance (VIS-Assistance®) were calculated. One or more STIC volumes (365 in total) were obtained successfully in 72.5% (150/207) of women undergoing ultrasound examination. Of the 365 volumes evaluated by STICLoop, 351 (96.2%) were considered to be appropriate. From the 351 STIC volumes, only one STIC volume per patient (n = 150) was analyzed using the FINE method, and consequently nine fetal echocardiography views were generated in 76-100% of cases using diagnostic planes only, in 98-100% of cases using VIS-Assistance only, and in 98-100% of cases when using a combination of diagnostic planes and/or VIS-Assistance. In women between 19 and 30 weeks' gestation with a normal fetal heart undergoing prospective sonographic examination, STIC volumes can be obtained successfully in 72.5% of cases. The FINE method can be applied to generate nine standard fetal echocardiography views in 98-100% of these cases using a combination of diagnostic planes and/or VIS-Assistance. This suggests that FINE could be implemented in fetal cardiac screening programs. Published 2015. This article is a U.S. Government work and is in

Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial.

PubMed

Surran, B; Visintainer, P; Chamberlain, S; Kopcza, K; Shah, B; Singh, R

2013-12-01

To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures. A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.

Does the unexpected death of the manikin in a simulation maintain the participants' perceived self-efficacy? An observational prospective study with medical students.

PubMed

Weiss, Anne; Jaffrelot, Morgan; Bartier, Jean-Claude; Pottecher, Thierry; Borraccia, Isabelle; Mahoudeau, Gilles; Noll, Eric; Brunstein, Véronique; Delacour, Chloé; Pelaccia, Thierry

2017-07-06

The death of a simulated patient is controversial. Some educators feel that having a manikin die is prejudicial to learning; others feel it is a way of better preparing students for these situations. Perceived self-efficacy (PSE) reflects a person's perception of their ability to carry out a task. A high PSE is necessary to manage a task efficiently. In this study, we measured the impact of the death of a simulated patient on medical students' perceived self-efficacy concerning their ability to cope with a situation of cardiac arrest. We carried out a single-centre, observational, prospective study. In group 1 (n = 27), pre-graduate medical students were warned of the possible death of the manikin; group 2 students were not warned (n = 29). The students' PSE was measured at the end of the simulated situation and after the debriefing. The PSE of the two groups was similar before the debriefing (p = 0.41). It had significantly progressed at the end of the debriefing (p < 0,001). No significant difference was noted between the 2 groups (p = 0.382). The simulated death of the manikin did not have a negative impact on the students' PSE, whether or not they had been warned of the possible occurrence of such an event. Our study helps defend the position which supports the inclusion of unexpected death of the manikin in a simulation setting.

The efficacy of stuttering measurement training: evaluating two training programs.

PubMed

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

2015-04-01

Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Four groups, each with 12 randomly allocated participants, completed a pretest-posttest design training study. They were evaluated by their counts of stuttering events on eight 3-min audiovisual speech samples from adults and children who stutter. Stuttering judgment training involved use of either the Stuttering Measurement System (SMS), Stuttering Measurement Assessment and Training (SMAAT) programs, or no training. To test for the reliability of any training effect, SMS training was repeated with the 4th group. Both SMS-trained groups produced approximately 34% improvement, significantly better than no training or the SMAAT program. The SMAAT program produced a mixed result. The SMS program was shown to produce a "medium" effect size improvement in the accuracy of stuttering event counts, and this improvement was almost perfectly replicated in a 2nd group. Half of the SMAAT judges produced a 36% improvement in accuracy, but the other half showed no improvement. Additional studies are needed to demonstrate the durability of the reported improvements, but these positive effects justify the importance of stuttering measurement training.

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.

Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial.

PubMed

Voskanyan, Lilit; García-Feijoó, Julián; Belda, Jose I; Fea, Antonio; Jünemann, Anselm; Baudouin, Christophe

2014-02-01

Micro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure. The aim of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy after ab interno implantation of two Glaukos Trabecular Micro-Bypass iStent inject second generation devices in subjects with OAG. This study was performed at sites in France, Germany, Italy, Republic of Armenia, and Spain. In this pan-European, multi-center prospective, post-market, unmasked study, 99 patients with OAG on at least two topical ocular hypotensive medications who required additional IOP lowering to control glaucoma disease underwent implantation of two GTS400 stents in a stand-alone procedure. Patients were qualified if they presented with preoperative mean IOP between 22 and 38 mmHg after medication washout. Postoperatively, subjects were assessed at Day 1, Months 1, 3, 6, 7, 9, and 12. IOP, medication use and safety were assessed at each visit. Sixty-six percent of subjects achieved IOP ≤18 mmHg at 12 months without medication, and 81% of subjects achieved Month 12 IOP ≤ 18 mmHg with either a single medication or no medication. Mean baseline washout IOP values decreased by 10.2 mmHg or 39.7% from 26.3 (SD 3.5) mmHg to 15.7 (SD 3.7) mmHg at Month 12. Mean IOP at 12 months was 14.7 (SD 3.1) mmHg in subjects not using ocular hypotensive medications. Reduction from preoperative medication burden was achieved in 86.9% of patients, including 15.2% with reduction of one medication and 71.7% with reduction of two or more medications. Postoperative complications occurred at a low rate and resolved without persistent effects. In this series, implantation of two trabecular micro-bypass second generation stents in subjects with OAG resulted in IOP and medication reduction and favorable safety outcomes.

A Professional Development Program Evaluation: Teacher Efficacy, Learning, and Transfer

ERIC Educational Resources Information Center

Tomonari, Dana Anne Miyuki

2012-01-01

Although professional development is an important means of improving both teachers' skills and student outcomes, there is a dearth of high quality empirical research on the efficacy of such efforts. The efficacy of the Challenging Behavior Process was assessed using a mixed method approach which included the use of pre-, post-, and follow-up…

Prospective evaluation of oro-pharyngeal dysphagia after severe traumatic brain injury.

PubMed

Terré, Rosa; Mearin, Fermín

2007-12-01

To evaluate clinical, videofluoroscopic findings and clinical evolution of neurogenic dysphagia and to establish the prognostic factors. Prospective cohort study. Forty-eight patients with severe traumatic brain injury (TBI) and clinically-suspected oro-pharyngeal dysphagia were studied. Clinical evaluation of oro-pharyngeal dysphagia and videofluoroscopic examination were performed. Clinical evolution was based on feeding mode at discharge, the presence of respiratory complications and body mass index (BMI) at admission and at discharge. Sixty-five per cent of patients had impaired gag reflex and 44% cough during oral feeding. Videofluoroscopy revealed some type of disorder in 90% of cases: 65% in the oral phase and 73% in the pharyngeal phase (aspiration in 62.5%, being silent in 41%). At discharge, 45% were on normal diet, 27% on a modified oral diet, 14% combined oral intake and gastrostomy feeding and 14% were fed exclusively by gastrostomy. Feeding mode at discharge substantially correlated with RLCF score at admission (p=0.04) and with RLCF (p=0.009) and DRS (p=0.02) scores at discharge. Aspiration is very frequent in patients with severe TBI, being silent in almost half. Cognitive function evaluated with the RLCF is the best prognostic factor. At discharge, 72% of the patients were on oral food intake despite having severe TBI.

Pharmacogenetics-based area-under-curve model can predict efficacy and adverse events from axitinib in individual patients with advanced renal cell carcinoma.

PubMed

Yamamoto, Yoshiaki; Tsunedomi, Ryouichi; Fujita, Yusuke; Otori, Toru; Ohba, Mitsuyoshi; Kawai, Yoshihisa; Hirata, Hiroshi; Matsumoto, Hiroaki; Haginaka, Jun; Suzuki, Shigeo; Dahiya, Rajvir; Hamamoto, Yoshihiko; Matsuyama, Kenji; Hazama, Shoichi; Nagano, Hiroaki; Matsuyama, Hideyasu

2018-03-30

We investigated the relationship between axitinib pharmacogenetics and clinical efficacy/adverse events in advanced renal cell carcinoma (RCC) and established a model to predict clinical efficacy and adverse events using pharmacokinetic and gene polymorphisms related to drug metabolism and efflux in a phase II trial. We prospectively evaluated the area under the plasma concentration-time curve (AUC) of axitinib, objective response rate, and adverse events in 44 consecutive advanced RCC patients treated with axitinib. To establish a model for predicting clinical efficacy and adverse events, polymorphisms in genes including ABC transporters ( ABCB1 and ABCG2 ), UGT1A , and OR2B11 were analyzed by whole-exome sequencing, Sanger sequencing, and DNA microarray. To validate this prediction model, calculated AUC by 6 gene polymorphisms was compared with actual AUC in 16 additional consecutive patients prospectively. Actual AUC significantly correlated with the objective response rate ( P = 0.0002) and adverse events (hand-foot syndrome, P = 0.0055; and hypothyroidism, P = 0.0381). Calculated AUC significantly correlated with actual AUC ( P < 0.0001), and correctly predicted objective response rate ( P = 0.0044) as well as adverse events ( P = 0.0191 and 0.0082, respectively). In the validation study, calculated AUC prior to axitinib treatment precisely predicted actual AUC after axitinib treatment ( P = 0.0066). Our pharmacogenetics-based AUC prediction model may determine the optimal initial dose of axitinib, and thus facilitate better treatment of patients with advanced RCC.

Pharmacogenetics-based area-under-curve model can predict efficacy and adverse events from axitinib in individual patients with advanced renal cell carcinoma

PubMed Central

Yamamoto, Yoshiaki; Tsunedomi, Ryouichi; Fujita, Yusuke; Otori, Toru; Ohba, Mitsuyoshi; Kawai, Yoshihisa; Hirata, Hiroshi; Matsumoto, Hiroaki; Haginaka, Jun; Suzuki, Shigeo; Dahiya, Rajvir; Hamamoto, Yoshihiko; Matsuyama, Kenji; Hazama, Shoichi; Nagano, Hiroaki; Matsuyama, Hideyasu

2018-01-01

We investigated the relationship between axitinib pharmacogenetics and clinical efficacy/adverse events in advanced renal cell carcinoma (RCC) and established a model to predict clinical efficacy and adverse events using pharmacokinetic and gene polymorphisms related to drug metabolism and efflux in a phase II trial. We prospectively evaluated the area under the plasma concentration–time curve (AUC) of axitinib, objective response rate, and adverse events in 44 consecutive advanced RCC patients treated with axitinib. To establish a model for predicting clinical efficacy and adverse events, polymorphisms in genes including ABC transporters (ABCB1 and ABCG2), UGT1A, and OR2B11 were analyzed by whole-exome sequencing, Sanger sequencing, and DNA microarray. To validate this prediction model, calculated AUC by 6 gene polymorphisms was compared with actual AUC in 16 additional consecutive patients prospectively. Actual AUC significantly correlated with the objective response rate (P = 0.0002) and adverse events (hand-foot syndrome, P = 0.0055; and hypothyroidism, P = 0.0381). Calculated AUC significantly correlated with actual AUC (P < 0.0001), and correctly predicted objective response rate (P = 0.0044) as well as adverse events (P = 0.0191 and 0.0082, respectively). In the validation study, calculated AUC prior to axitinib treatment precisely predicted actual AUC after axitinib treatment (P = 0.0066). Our pharmacogenetics-based AUC prediction model may determine the optimal initial dose of axitinib, and thus facilitate better treatment of patients with advanced RCC. PMID:29682213

Efficacy of feline anti-parvovirus antibodies in the treatment of canine parvovirus infection.

PubMed

Gerlach, M; Proksch, A L; Unterer, S; Speck, S; Truyen, U; Hartmann, K

2017-07-01

This prospective, randomised, placebo-controlled, double-blinded study aimed to evaluate efficacy of commercially available feline anti-parvovirus antibodies in dogs with canine parvovirus infection. First, cross-protection of feline panleukopenia virus antibodies against canine parvovirus was evaluated in vitro. In the subsequent prospective clinical trial, 31 dogs with clinical signs of canine parvovirus infection and a positive faecal canine parvovirus polymerase chain reaction were randomly assigned to a group receiving feline panleukopenia virus antibodies (n=15) or placebo (n=16). All dogs received additional routine treatment. Clinical signs, blood parameters, time to clinical recovery and mortality were compared between the groups. Serum antibody titres and quantitative faecal polymerase chain reaction were compared on days 0, 3, 7, and 14. In vitro, canine parvovirus was fully neutralised by feline panleukopenia virus antibodies. There were no detected significant differences in clinical signs, time to clinical recovery, blood parameters, mortality, faecal virus load, or viral shedding between groups. Dogs in the placebo group showed a significant increase of serum antibody titres and a significant decrease of faecal virus load between day 14 and day 0, which was not detectable in dogs treated with feline panleukopenia virus antibodies. No significant beneficial effect of passively transferred feline anti-parvovirus antibodies in the used dosage regimen on the treatment of canine parvovirus infection was demonstrated. © 2017 British Small Animal Veterinary Association.

Why are adult women physically active? A systematic review of prospective cohort studies to identify intrapersonal, social environmental and physical environmental determinants.

PubMed

Prince, S A; Reed, J L; Martinello, N; Adamo, K B; Fodor, J G; Hiremath, S; Kristjansson, E A; Mullen, K A; Nerenberg, K A; Tulloch, H E; Reid, R D

2016-10-01

This study aims to systematically review available evidence from prospective cohort studies to identify intrapersonal, social environmental and physical environmental determinants of moderate-to-vigorous intensity physical activity (MVPA) among working-age women. Six databases were searched to identify all prospective cohort studies that reported on intrapersonal (e.g. self-efficacy and socioeconomic status [SES]), social (e.g. crime, area SES and social support) and/or physical (e.g. weather, work and recreation) environmental determinants of MVPA in working-age (mean 18-65 years) women. A qualitative synthesis including harvest plots was completed. CRD42014009750 RESULTS: Searching identified 17,387 potential articles; 97 were used in the analysis. The majority (n = 87 studies) reported on ≥1 intrapersonal determinant. Very few (n = 34) examined factors in the social or physical environments, and none looked at social policy. Positive and consistent influencers included higher self-efficacy (n = 18/23), self-rated health (n = 8/13) and intentions (n = 10/11) and perceived behavioural control (n = 5/7) to be physically active. Having children in the household was negatively related to MVPA (n = 9/15). Physical activity intervention studies should consider a woman's level of self-efficacy and perceived behavioural control to be physically active. Additional studies are needed on the impact of children in the household, having a spouse/partner and using group goal setting. More evidence is needed to evaluate the impact of environmental factors. © 2016 World Obesity.

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

Evaluation of barium hydroxide treatment efficacy on a dolomitic marble.

PubMed

Toniolo, L; Colombo, C; Realini, M; Peraio, A; Positano, M

2001-01-01

The Arch of Peace, by Luigi Cagnola, is one of the most famous neoclassical monuments in Milan. It has been subjected to conservative intervention in 1998. In the present paper the efficacy of the consolidation by means of barium hydroxide has been evaluated. The stone material showed severe degradation phenomena as: erosion, pulverisation, exfoliation. The analytical data acquired through X-ray diffraction (XRD), infrared spectrophotometry (FTIR) and scanning electron microscopy (SEM-EDX), allowed to compare the conditions of stone before and after the treatment with barium hydroxide. The presence of barium has been put in evidence mainly on the surface as barium sulphate, whereas barium is only sporadically present within the thickness of the decayed material. The treatment was judged not satisfying and its inefficacy is, most probably, due to a not suitable cleaning procedure carried out before the consolidation.

The efficacy of intravenous ketorolac for pain relief in single-stage adjustable strabismus surgery: a prospective, randomized, placebo-controlled trial

PubMed Central

Rhiu, S; Chung, S A; Kim, W K; Chang, J H; Bae, S J; Lee, J B

2011-01-01

Purpose To determine the efficacy of preoperative intravenous ketorolac in reducing intraoperative and postoperative pain and improving patient satisfaction in patients undergoing single-stage adjustable strabismus surgery. Methods A prospective, randomized, placebo-controlled clinical trial was performed with 67 patients who underwent horizontal recti muscle surgery with adjustable sutures. The test group received intravenous ketorolac (60 mg) before surgery, and the control group received intravenous normal saline. Topical 0.5% proparacaine was administered to both groups during surgery. Vital signs including heart rate and blood pressure were recorded every 10 min throughout the surgery. The patients were asked to rate their maximum intraoperative and postoperative pain scores using a numerical pain rating scale. Patient satisfaction was also assessed using a five-point analogue scale. Results The ketorolac-premedicated patients had less pain both during and after surgery (P=0.033 and P=0.024, respectively). There were no differences in vital signs during surgery and patient satisfaction between the two groups. Conclusions Intravenous ketorolac, when administered preoperatively for single-stage adjustable strabismus surgery under topical anaesthesia, was effective in reducing pain during and after surgery. PMID:21102493

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

PubMed

Amarapurkar, Deepak N; Rane, Priya

2004-12-01

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

The efficacy and safety of cold-induced lipolysis in the treatment of pseudogynecomastia.

PubMed

Park, Jung Tae; Kwon, Soon Hyo; Shin, Jung Won; Park, Kyoung Chan; Na, Jung Im; Huh, Chang Hun

2016-08-01

The treatment options for pseudogynecomastia have been limited. Cold-induced lipolysis provides a noninvasive, localized subcutaneous adipocyte destruction by inducing adipocyte apoptosis. This study has been designed to evaluate the efficacy of cold-induced lipolysis as a treatment modality for pseudogynecomastia. In this 28-week prospective trial, a total of 12 male pseudogynecomastia patients (Korean) were treated twice with cold-induced lipolysis. Efficacy was determined by chest circumference, ultrasonographic measurement of fat thickness, Simon's Gynecomastia class (SGC), photographic assessment, and the patient's satisfaction (baseline, weeks 4, 8, 16, and 28). Using a questionnaire, safety was evaluated at each visit. For 10 subjects that completed the trial, chest circumference and fat thickness significantly improved by week 8. This same improvement was gradually noticed through week 28. The patients SGC scores continuously decreased after two sessions. Photographic assessment showed an improvement until week 28. The result of the patient's satisfaction score was also meaningful. While there were no adverse events observed, transient pain and bruising at the treatment site were noticed. We recruited a limited number of participants. Also, we could not exclude there might be other individual factors in association with the patients pseudogynecomastia. Cold-induced lipolysis is a safe, effective therapeutic option in the treatment of pseudogynecomastia. Lasers Surg. Med. 48:584-589, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

A prospective evaluation of plastibell® circumcision in older children.

PubMed

Bastos Netto, José Murillo; Gonçalves de Araújo, José; Noronha, Marcos Flávio de Almeida; Passos, Bruno Rezende; Lopes, Humberto Elias; Bessa, José de; Figueiredo, André Avarese

2013-01-01

Circumcision is one of the oldest surgical procedures and one of the most frequently performed worldwide. It can be done by many different techniques. This prospective series presents the results of Plastibell® circumcision in children older than 2 years of age, evaluating surgical duration, immediate and late complications, time for plastic device separation and factors associated with it. We prospectively analyzed 119 children submitted to Plastic Device Circumcision with Plastibell® by only one surgeon from December 2009 to June 2011. In all cases the surgery was done under general anesthesia associated with dorsal penile nerve block. Before surgery length of the penis and latero-lateral diameter of the glans were measured. Surgical duration, time of Plastibell® separation and use of analgesic medication in the post-operative period were evaluated. Patients were followed on days 15, 45, 90 and 120 after surgery. Age at surgery varied from 2 to 12.5 (5.9 ± 2.9) years old. Mean surgical time was 3.7 ± 2.0 minutes (1.9 to 9 minutes). Time for plastic device separation ranged from 6 to 26 days (mean: 16 ± 4.2 days), being 14.8 days for children younger than 5 years of age and 17.4 days for those older than 5 years of age (p < 0.0001). The diameter of the Plastibell® does not interfered in separations time (p = 0,484). Late complications occurred in 32 (26.8%) subjects, being the great majority of low clinical significance, especially prepucial adherences, edema of the mucosa and discrete hypertrophy of the scar, all resolving with clinical treatment. One patient still using diaper had meatus stenosis and in one case the Plastibell® device stayed between the glans and the prepuce and needed to be removed manually. Circumcision using a plastic device is a safe, quick and an easy technique with low complications, that when occur are of low clinical importance and of easy resolution. The mean time for the device to fall is shorter in children under 6 years of

Programme Recruitment and Evaluation: The Effect of an Employability Enhancement Programme on the General Self-Efficacy Levels of Unemployed Graduates

ERIC Educational Resources Information Center

Hazenberg, R.; Seddon, F.; Denny, S.

2015-01-01

This paper reports research that engaged in the evaluation of an intervention programme designed to enhance the employability of a group of unemployed graduates. The evaluation adopted a quasi-experimental intervention research method employing a general self-efficacy scale, which had been validated in prior research. Results revealed that…

Examining the Efficacy of Adjunctive Aripiprazole in Major Depressive Disorder: A Pooled Analysis of 2 Studies

PubMed Central

Thase, Michael E.; Trivedi, Madhukar H.; Nelson, J. Craig; Fava, Maurizio; Swanink, Rene; Tran, Quynh-Van; Pikalov, Andrei; Yang, Huyuan; Carlson, Berit X.; Marcus, Ronald N.; Berman, Robert M.

2008-01-01

Background: Patients with major depressive disorder (MDD) who fail to achieve complete remission with antidepressant therapy may benefit from augmentation therapy with an atypical antipsychotic. Method: A pooled analysis was performed on 2 identical 14-week studies (8-week prospective antidepressant therapy treatment phase followed by 6-week randomized double-blind phase) evaluating the efficacy of adjunctive aripiprazole (2–20 mg/day) in DSM-IV-TR–defined MDD patients with an inadequate response to antidepressant therapy. Primary efficacy endpoint was the mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from end of the prospective phase (week 8) to end of randomized phase (week 14, last observation carried forward). Subgroup analyses were performed. The key secondary endpoint was mean change in Sheehan Disability Scale (SDS) mean score. Results: At endpoint, mean change in MADRS total score was significantly greater with adjunctive aripiprazole (–8.7) than with adjunctive placebo (–5.7; p < .001). Except for a differential treatment-by-sex interaction, change in MADRS total scores were consistently greater with adjunctive aripiprazole than with adjunctive placebo, regardless of race, age, episode duration, prior antidepressant therapy response, number of historical treatment failures, severity of depressive symptoms, and antidepressant. At endpoint, MADRS remission rates were significantly greater with adjunctive aripiprazole than with placebo (25.7% vs. 15.4%; p < .001). Adjunctive aripiprazole also demonstrated significantly greater improvements in mean change from baseline in SDS total score than adjunctive placebo (–1.2 vs. –0.6; p = .001). Conclusion: Augmentation of antidepressant therapy with the atypical antipsychotic aripiprazole resulted in significant efficacy benefits across a range of subgroups of patients with MDD. Further study of a treatment-by-sex interaction is needed. Trial Registration: www

Evaluation of high-intensity focused ultrasound ablation for uterine fibroids: an IDEAL prospective exploration study.

PubMed

Chen, J; Li, Y; Wang, Z; McCulloch, P; Hu, L; Chen, W; Liu, G; Li, J; Lang, J

2018-02-01

To evaluate the clinical outcomes of high-intensity focused ultrasound (HIFU) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial. Prospective multicentre patient choice cohort study (IDEAL Exploratory study) of HIFU, myomectomy or hysterectomy for treating symptomatic uterine fibroids. 20 Chinese hospitals. 2411 Chinese women with symptomatic fibroids. Prospective non-randomised cohort study with learning curve analysis (IDEAL Stage 2b Prospective Exploration Study). Complications, hospital stay, return to normal activities, and quality of life (measured with UFS-Qol and SF-36 at baseline, 6 and 12 months), and need for further treatment. Quality-of-life outcomes were adjusted using regression modelling. HIFU treatment quality was evaluated using LC-CUSUM to identify operator learning curves. A health economic analysis of costs was performed. 1353 women received HIFU, 472 hysterectomy and 586 myomectomy. HIFU patients were significantly younger (P < 0.001), slimmer (P < 0.001), better educated (P < 0.001), and wealthier (P = 0.002) than surgery patients. Both UFS and QoL improved more rapidly after HIFU than after surgery (P = 0.002 and P = 0.001, respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of HIFU and in 133 (12.6%) of surgical cases (P < 0.001). Median time for hospital stay was 4 days (interquartile range, 0-5 days), 10 days (interquartile range, 8-12.5 days) and 8 days (interquartile range, 7-10 days). HIFU caused substantially less morbidity than surgery, with similar longer-term QoL. Despite group baseline differences and lack of blinding, these findings support the need for a randomised controlled trial (RCT) of HIFU treatment for fibroids. The IDEAL Exploratory design facilitated RCT protocol development. HIFU had much better short-term outcomes than surgery for fibroids in 2411-patient Chinese IDEAL format study. © 2017 Royal College of Obstetricians and

Clinical efficacy of melittin in the treatment of cats infected with the feline immunodeficiency virus.

PubMed

Hartmann, Anja D; Wilhelm, Natalie; Erfle, Volker; Hartmann, Katrin

2016-12-05

The bee venom melittin shows an antiviral efficacy against the human immunodeficiency virus in cell culture. It was shown to be non-toxic for cats. Aim of this pilot study was to investigate the clinical efficacy and side-effects of melittin in cats naturally infected with feline immunodeficiency virus (FIV). The study was performed as a prospective, placebo-controlled double-blinded trial. Twenty cats were included, of which 10 cats each were treated with either melittin (500 µg/kg body weight) or phosphate-buffered saline (placebo) subcutaneously twice per week. During the treatment period of 6 weeks, the cats' general health status, determined by the Karnofsky's score, and the severity of clinical signs (conjunctivitis and stomatitis) using a clinical scoring system were evaluated. Haematology, biochemistry profiles, lymphocyte subpopulations, CD4/CD8 ratio, and pterines (biopterine, 7-xanthopterine) as surrogate parameters were also compared. The general health status and the clinical scores for conjunctivitis and stomatitis improved in cats treated with melittin. A statistically significant improvement however could only be detected for conjunctivitis in cats treated with melittin compared to cats treated with placebo which was likely due to different scores between both groups at the beginning. No influence on the lymphocyte subpopulations, CD4/CD8 ratio, and pterine concentrations was observed. No side effects occurred in this study. In the protocol used in the present study, no significant efficacy of melittin could be detected. However, efficacy of melittin, especially if applied in a higher dosage as in the present study or for a longer period, could be evaluated in further studies. Synergistic effects if used in combination with classic antiretroviral drugs could be an interesting future approach.

The efficacy and tolerability of 5-aminolevulinic acid 5% thermosetting gel photodynamic therapy (PDT) in the treatment of mild-to-moderate acne vulgaris. A two-center, prospective assessor-blinded, proof-of-concept study.

PubMed

Serini, Stefano Maria; Cannizzaro, Maria Vittoria; Dattola, Annunziata; Garofalo, Virginia; Del Duca, Esther; Ventura, Alessandra; Milani, Massimo; Campione, Elena; Bianchi, Luca

2018-05-22

Acne vulgaris is a chronic inflammatory skin disease, commonly treated with topical or systemic drugs, according to the severity of the condition. Retinoids and antibiotic compounds are considered cornerstone approaches in this condition. However, low adherence to the therapy and the issue of bacterial resistance undermine the efficacy in the long term. Photodynamic therapy (PDT) with 20% aminolevulinic acid (ALA) has shown to be effective in the treatment of inflammatory acne. Skin tolerability, however, could be a limiting factor for a widespread use of this approach. A new formulation of 5% ALA in thermosetting gel has been recently available. This formulation allows a more convenient application procedure without occlusion and better and more efficient release of the active compound in comparison with traditional ALA formulations like creams or ointments. To evaluate in a two-center, assessor-blinded, prospective, proof-of-concept study, the efficacy, and tolerability of red-light (630 nm) PDT with a new 5-ALA "low-dose" topical gel formulation (5%) in the treatment of inflammatory mild-to-moderate acne vulgaris (AV). A total of 35 subjects with moderate AV of the face (mean age: 24 ± 8 years, 13 men and 22 women) were enrolled, after their written informed consent. The primary outcome was the evolution of GAG (Global Acne Grade System) score at baseline and after an average of three, 630-nm, 15-minute, PDT sessions, performed every 2 weeks. GAG score was also calculated in a follow-up visit 6 months after the last PDT session. Skin tolerability was assessed during PDT sessions with a patient-reported discomfort level evaluation score from 0 (no discomfort at all) to 3 (severe discomfort). At baseline, the GAG score was 21 ± 6. After the last PDT session, the GAG score evaluated in a blinded fashion (digital photographs) was significantly reduced to 6.5 ± 5.7, representing a 70% reduction (P = .0001, Wilcoxon test; mean difference 14.9; 95% CI of

[Treatment of interstitial cystitis by intravesical instillation of hyaluronic acid: A prospective study on 31 patients].

PubMed

Van Agt, S; Gobet, F; Sibert, L; Leroi, A-M; Grise, P

2011-03-01

We evaluate the efficacy of hyaluronate acid instillation for treatment of interstitial cystitis (IC). From March 2008 to May 2009, a prospective study included 31 patients. We used the new definition of IC established by the ICS in 2002. Patients have a urinalysis, a cystoscopy, a hydrodistension test and bladder biopsies. The urodynamic evaluation was not systematic. Patients received weekly six instillations of 40mg (50ml) intravesical hyaluronate acid. We evaluated the efficacy and safety of treatment with two specific questionnaires of interstitial cystitis filled before and after 6 weeks of treatment: the O'Leary-Sant and Pelvic pain and Urgency/Frequency (PUF). Four groups were defined: good response, partial response, poor response and no response. They were composed by 14 patients (45%), two (7%), seven (22%) and eight patients (26%). We obtained 52% positive response (good response and partial response) after 6 weeks of treatment. Patients with cystoscopy and histology abnormal had a response rate of 60%. No serious side effects were observed. Hyaluronate acid has a place in the treatment of interstitial cystitis with an efficiency comparable to other treatments and good tolerance. The response rate to treatment can be improved by better selection of patients, particularly those having a cystoscopy and histology abnormal. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

Influences of Self-Efficacy, Response Efficacy, and Reactance on Responses to Cigarette Health Warnings: A Longitudinal Study of Adult Smokers in Australia and Canada

PubMed Central

Thrasher, James F.; Swayampakala, Kamala; Borland, Ron; Nagelhout, Gera; Yong, Hua-Hie; Hammond, David; Bansal-Travers, Maansi; Thompson, Mary; Hardin, James

2016-01-01

ABSTRACT Guided by the extended parallel process model (EPPM) and reactance theory, this study examined the relationship between efficacy beliefs, reactance, and adult smokers’ responses to pictorial health warning labels (HWL) on cigarette packaging, including whether efficacy beliefs or reactance modify the relationship between HWL responses and subsequent smoking cessation behavior. Four waves of data were analyzed from prospective cohorts of smokers in Australia and Canada (n = 7,120 observations) over a period of time after implementation of more prominent, pictorial HWLs. Three types of HWL responses were studied: psychological threat responses (i.e., thinking about risks from smoking), forgoing cigarettes due to HWLs, and avoiding HWLs. The results from Generalized Estimating Equation models indicated that stronger efficacy beliefs and lower trait reactance were significantly associated with greater psychological threat responses to HWLs. Similar results were found for models predicting forgoing behavior, although response efficacy was inversely associated with it. Only response efficacy was significantly associated with avoiding HWLs, showing a positive relationship. Higher self-efficacy and stronger responses to HWLs, no matter the type, were associated with attempting to quit in the follow-up period; reactance was unassociated. No statistically significant interactions were found. These results suggest that stronger efficacy beliefs and lower trait reactance are associated with some stronger responses to fear-arousing HWL responses; however, these HWL responses appear no less likely to lead to cessation attempts among smokers with different levels of self-efficacy to quit, of response efficacy beliefs, or of trait reactance against attempts to control their behavior. PMID:27135826

Evaluation of micro-organism-detaching efficacy from meat samples by spindle or stomacher treatment and quality analysis of suspensions.

PubMed

Kim, S-J; Kim, D-K; Kang, D-H

2016-04-01

We investigated and compared the efficacy of a new apparatus for detaching micro-organisms from meat samples. The efficacy of Spindle and stomacher in detaching micro-organisms from meat samples was evaluated. Also, evaluation of appropriateness of suspensions generated by both methods for carrying out molecular biological analysis was implemented. A nearly identical correlation and high R(2) were obtained between Spindle and stomacher in Aerobic Plate Count (APC), and no significant differences were observed in detachment of three major foodborne pathogens. The suspension generated by the Spindle showed lower turbidity and total protein concentration. Also, significantly different threshold cycles were observed in Real-time PCR analysis using suspensions generated by both methods. The Spindle shows nearly identical efficacy with stomacher treatment in detaching micro-organisms from meat samples. Furthermore, the high quality of suspensions generated by the Spindle, in terms of turbidity and total protein assay, allows for a lower threshold cycle than stomached suspension in Real-time PCR. The Spindle could be an alternative method for detaching micro-organisms, yielding a higher quality of suspensions which may be better suited for further molecular microbiological analysis. © 2016 The Society for Applied Microbiology.

Evaluating Heat Pipe Performance in 1/6 g Acceleration: Problems and Prospects

NASA Technical Reports Server (NTRS)

Jaworske, Donald A.; McCollum, Timothy A.; Gibson, Marc A.; Sanzi, James L.; Sechkar, Edward A.

2011-01-01

Heat pipes composed of titanium and water are being considered for use in the heat rejection system of a fission power system option for lunar exploration. Placed vertically on the lunar surface, the heat pipes would operate as thermosyphons in the 1/6 g environment. The design of thermosyphons for such an application is determined, in part, by the flooding limit. Flooding is composed of two components, the thickness of the fluid film on the walls of the thermosyphon and the interaction of the fluid flow with the concurrent vapor counter flow. Both the fluid thickness contribution and interfacial shear contribution are inversely proportional to gravity. Hence, evaluating the performance of a thermosyphon in a 1 g environment on Earth may inadvertently lead to overestimating the performance of the same thermosyphon as experienced in the 1/6 g environment on the moon. Several concepts of varying complexity have been proposed for evaluating thermosyphon performance in reduced gravity, ranging from tilting the thermosyphons on Earth based on a cosine function, to flying heat pipes on a low-g aircraft. This paper summarizes the problems and prospects for evaluating thermosyphon performance in 1/6 g.

Identification of Granulocyte Colony-Stimulating Factor and Interleukin-6 as Candidate Biomarkers of CBLB502 Efficacy as a Medical Radiation Countermeasure

PubMed Central

Krivokrysenko, Vadim I.; Shakhov, Alexander N.; Singh, Vijay K.; Bone, Frederick; Kononov, Yevgeniy; Shyshynova, Inna; Cheney, Alec; Maitra, Ratan K.; Purmal, Andrei; Whitnall, Mark H.; Feinstein, Elena

2012-01-01

Given an ever-increasing risk of nuclear and radiological emergencies, there is a critical need for development of medical radiation countermeasures (MRCs) that are safe, easily administered, and effective in preventing and/or mitigating the potentially lethal tissue damage caused by acute high-dose radiation exposure. Because the efficacy of MRCs for this indication cannot be ethically tested in humans, development of such drugs is guided by the Food and Drug Administration's Animal Efficacy Rule. According to this rule, human efficacious doses can be projected from experimentally established animal efficacious doses based on the equivalence of the drug's effects on efficacy biomarkers in the respective species. Therefore, identification of efficacy biomarkers is critically important for drug development under the Animal Efficacy Rule. CBLB502 is a truncated derivative of the Salmonella flagellin protein that acts by triggering Toll-like receptor 5 (TLR5) signaling and is currently under development as a MRC. Here, we report identification of two cytokines, granulocyte colony-stimulating factor (G-CSF) and interleukin-6 (IL-6), as candidate biomarkers of CBLB502's radioprotective/mitigative efficacy. Induction of both G-CSF and IL-6 by CBLB502 1) is strictly TLR5-dependent, 2) occurs in a CBLB502 dose-dependent manner within its efficacious dose range in both nonirradiated and irradiated mammals, including nonhuman primates, and 3) is critically important for the ability of CBLB502 to rescue irradiated animals from death. After evaluation of CBLB502 effects on G-CSF and IL-6 levels in humans, these biomarkers will be useful for accurate prediction of human efficacious CBLB502 doses, a key step in the development of this prospective radiation countermeasure. PMID:22837010

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…

A Method for Evaluating Insecticide Efficacy against Bed Bug, Cimex lectularius, Eggs and First Instars.

PubMed

Campbell, Brittany E; Miller, Dini M

2017-03-15

Standard toxicity evaluations of insecticides against insect pests are primarily conducted on adult insects. Evaluations are based on a dose-response or concentration-response curve, where mortality increases as the dose or concentration of an insecticide is increased. Standard lethal concentration (LC50) and lethal dose (LD50) tests that result in 50% mortality of a test population can be challenging for evaluating toxicity of insecticides against non-adult insect life stages, such as eggs and early instar or nymphal stages. However, this information is essential for understanding insecticide efficacy in all bed bug life stages, which affects control and treatment efforts. This protocol uses a standard dipping bioassay modified for bed bug eggs and a contact insecticidal assay for treating nymphal first instars. These assays produce a concentration-response curve to further quantify LC50 values for insecticide evaluations.

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.

Wound healing efficacy of Jatyadi Taila: in vivo evaluation in rat using excision wound model.

PubMed

Shailajan, Sunita; Menon, Sasikumar; Pednekar, Suhas; Singh, Ashish

2011-10-31

In traditional Indian medicinal treatise there are several Ayurvedic formulations mentioned which have been claimed as potential wound healing agents like Madhu Ghrita and Jatyadi Taila. Jatyadi Taila (JT) is a medicated oil formulation (Taila) popularly used in the treatment of various topical wounds. Though JT has its composition recorded in ancient Ayurvedic texts, there have been minimal attempts to standardize its use in the management of wound. The current work evaluates the wound healing efficacy of JT and also provides evidence of the dermal absorption kinetics of Karanjin from JT. JT was subjected to preliminary phytochemical evaluation. Therapeutically active marker components β-sitosterol, lupeol and karanjin were detected and separated using HPTLC. As a part of safety evaluation, skin irritation potential of JT was evaluated on rabbit skin. Excision wound model in rats were used to evaluate the wound healing efficacy of JT. Histopathological and biochemical evaluations of excised skin tissues at wound sites were carried out. The HPTLC method developed was also validated to evaluate the pharmacokinetics of Karanjin from JT after topical application on pinna of rabbit. Preliminary phytochemical evaluation of JT revealed presence of flavonoids, essential oils, tannins, glycosides, steroids and alkaloids while resins were found to be absent. HPTLC confirmed the presence of karanjin, lupeol and β-sitosterol in JT. JT was found to be non-irritant when applied to the skin of rabbits. Topical application of JT on excision wounds caused significantly faster reduction in wound area as compared to the application of modern topical formulation (Neosporin(®)) and untreated control wounds. Animals treated with JT showed significant increase in protein, hydroxyproline and hexosamine content in the granulation tissue when compared with the untreated controls. Wound healing potential of JT was found to be dose dependant. HPTLC method was successfully used to evaluate

Non-invasive treatment efficacy evaluation for high-intensity focused ultrasound therapy using magnetically induced magnetoacoustic measurement

NASA Astrophysics Data System (ADS)

Guo, Gepu; Wang, Jiawei; Ma, Qingyu; Tu, Juan; Zhang, Dong

2018-04-01

Although the application of high intensity focused ultrasound (HIFU) has been demonstrated to be a non-invasive treatment technology for tumor therapy, the real-time temperature monitoring is still a key issue in the practical application. Based on the temperature-impedance relation, a fixed-point magnetically induced magnetoacoustic measurement technology of treatment efficacy evaluation for tissue thermocoagulation during HIFU therapy is developed with a sensitive indicator of critical temperature monitoring in this study. With the acoustic excitation of a focused transducer in the magnetoacoustic tomography with the magnetic induction system, the distributions of acoustic pressure, temperature, electrical conductivity, and acoustic source strength in the focal region are simulated, and the treatment time dependences of the peak amplitude and the corresponding amplitude derivative under various acoustic powers are also achieved. It is proved that the strength peak of acoustic sources is generated by tissue thermocoagulation with a sharp conductivity variation. The peak amplitude of the transducer collected magnetoacoustic signal increases accordingly along with the increase in the treatment time under a fixed acoustic power. When the temperature in the range with the radial and axial widths of about ±0.46 mm and ±2.2 mm reaches 69 °C, an obvious peak of the amplitude derivative can be achieved and used as a sensitive indicator of the critical status of treatment efficacy. The favorable results prove the feasibility of real-time non-invasive temperature monitoring and treatment efficacy evaluation for HIFU ablation using the magnetically induced magnetoacoustic measurement, and might provide a new strategy for accurate dose control during HIFU therapy.

Treatment of obsessive morbid jealousy with cognitive analytic therapy: An adjudicated hermeneutic single-case efficacy design evaluation.

PubMed

Curling, Louise; Kellett, Stephen; Totterdell, Peter; Parry, Glenys; Hardy, Gillian; Berry, Katherine

2018-03-01

The evidence base for the treatment of morbid jealousy with integrative therapies is thin. This study explored the efficacy of cognitive analytic therapy (CAT). An adjudicated hermeneutic single-case efficacy design evaluated the cognitive analytic treatment of a patient meeting diagnostic criteria for obsessive morbid jealousy. A rich case record was developed using a matrix of nomothetic and ideographic quantitative and qualitative outcomes. This record was then debated by sceptic and affirmative research teams. Experienced psychotherapy researchers acted as judges, assessed the original case record, and heard the affirmative-versus-sceptic debate. Judges pronounced an opinion regarding the efficacy of the therapy. The efficacy of CAT was supported by all three judges. Each ruled that change had occurred due to the action of the therapy, beyond any level of reasonable doubt. This research demonstrates the potential usefulness of CAT in treating morbid jealousy and suggests that CAT is conceptually well suited. Suggestions for future clinical and research directions are provided. The relational approach of CAT makes it a suitable therapy for morbid jealousy. The narrative reformulation component of CAT appears to facilitate early change in chronic jealousy patterns. It is helpful for therapists during sessions to use CAT theory to diagrammatically spell out the patterns maintaining jealousy. © 2017 The British Psychological Society.

Preservice Teachers as Investigative Science Mentors: Advancing Self-Efficacy through School-Based Professional Development

ERIC Educational Resources Information Center

Flores, Ingrid M.

2015-01-01

Pedagogical competence and teaching efficacy significantly influence the quality of classroom science learning. Without applying pedagogical learning in realistic classroom environments, there is slight possibility that prospective teachers will increase their teaching confidence or develop understanding of how learners acquire and construct…

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

Evaluation of accuracy of IHI Trigger Tool in identifying adverse drug events: a prospective observational study.

PubMed

das Dores Graciano Silva, Maria; Martins, Maria Auxiliadora Parreiras; de Gouvêa Viana, Luciana; Passaglia, Luiz Guilherme; de Menezes, Renata Rezende; de Queiroz Oliveira, João Antonio; da Silva, Jose Luiz Padilha; Ribeiro, Antonio Luiz Pinho

2018-06-06

Adverse drug events (ADEs) can seriously compromise the safety and quality of care provided to hospitalized patients, requiring the adoption of accurate methods to monitor them. We sought to prospectively evaluate the accuracy of the triggers proposed by the Institute for Healthcare Improvement (IHI) for identifying ADEs. A prospective study was conducted in a public university hospital, in 2015, with patients ≥18 years. Triggers proposed by IHI and clinical alterations suspected to be ADEs were searched daily. The number of days in which the patient was hospitalized was considered as unit of measure to evaluate the accuracy of each trigger. Three hundred patients were included in this study. Mean age was 56.3 years (standard deviation (SD) 16.0), and 154 (51.3%) were female. The frequency of patients with ADEs was 24.7% and with at least one trigger was 53.3%. From those patients who had at least one trigger, the most frequent triggers were antiemetics (57.5%) and "abrupt medication stop" (31.8%). Triggers' sensitivity ranged from 0.3 to11.8 % and the positive predictive value ranged from 1.2 to 27.3%. Specificity and negative predictive value were greater than 86%. Most patients identified by the presence of triggers did not have ADEs (64.4%). No triggers were identified in 40 (38.5%) ADEs. IHI Trigger Tool did not show good accuracy in detecting ADEs in this prospective study. The adoption of combined strategies could enhance effectiveness in identifying patient safety flaws. Further discussion might contribute to improve trigger usefulness in clinical practice. This article is protected by copyright. All rights reserved.

The Efficacy of Stuttering Measurement Training: Evaluating Two Training Programs

PubMed Central

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

2015-01-01

Purpose Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Method Four groups, each with 12 randomly allocated participants, completed a pretest–posttest design training study. They were evaluated by their counts of stuttering events on eight 3-min audiovisual speech samples from adults and children who stutter. Stuttering judgment training involved use of either the Stuttering Measurement System (SMS), Stuttering Measurement Assessment and Training (SMAAT) programs, or no training. To test for the reliability of any training effect, SMS training was repeated with the 4th group. Results Both SMS-trained groups produced approximately 34% improvement, significantly better than no training or the SMAAT program. The SMAAT program produced a mixed result. Conclusions The SMS program was shown to produce a “medium” effect size improvement in the accuracy of stuttering event counts, and this improvement was almost perfectly replicated in a 2nd group. Half of the SMAAT judges produced a 36% improvement in accuracy, but the other half showed no improvement. Additional studies are needed to demonstrate the durability of the reported improvements, but these positive effects justify the importance of stuttering measurement training. PMID:25629956

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

PubMed

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

2018-06-01

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

A behavioural and neural evaluation of prospective decision-making under risk

PubMed Central

Symmonds, Mkael; Bossaerts, Peter; Dolan, Raymond J.

2010-01-01

Making the best choice when faced with a chain of decisions requires a person to judge both anticipated outcomes and future actions. Although economic decision-making models account for both risk and reward in single choice contexts there is a dearth of similar knowledge about sequential choice. Classical utility-based models assume that decision-makers select and follow an optimal pre-determined strategy, irrespective of the particular order in which options are presented. An alternative model involves continuously re-evaluating decision utilities, without prescribing a specific future set of choices. Here, using behavioral and functional magnetic resonance imaging (fMRI) data, we studied human subjects in a sequential choice task and use these data to compare alternative decision models of valuation and strategy selection. We provide evidence that subjects adopt a model of re-evaluating decision utilities, where available strategies are continuously updated and combined in assessing action values. We validate this model by using simultaneously-acquired fMRI data to show that sequential choice evokes a pattern of neural response consistent with a tracking of anticipated distribution of future reward, as expected in such a model. Thus, brain activity evoked at each decision point reflects the expected mean, variance and skewness of possible payoffs, consistent with the idea that sequential choice evokes a prospective evaluation of both available strategies and possible outcomes. PMID:20980595

The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial.

PubMed

Fleming, Jennifer; Ownsworth, Tamara; Doig, Emmah; Hutton, Lauren; Griffin, Janelle; Kendall, Melissa; Shum, David H K

2017-01-05

Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI. This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups. This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial

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.

Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study.

PubMed

Karpecki, Paul; Depaolis, Michael; Hunter, Judy A; White, Eric M; Rigel, Lee; Brunner, Lynne S; Usner, Dale W; Paterno, Michael R; Comstock, Timothy L

2009-03-01

Besifloxacin ophthalmic suspension 0.6% is a new topical fluoroquinolone for the treatment of bacterial conjunctivitis. Besifloxacin has potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. The primary objective of this study was to compare the clinical and microbiologic efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle (the formulation without besifloxacin) in the treatment of bacterial conjunctivitis. This was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study in patients with acute bacterial conjunctivitis. Patients received either topical besifloxacin ophthalmic suspension or vehicle administered 3 times daily for 5 days. At study entry and on days 4 and 8 (visits 2 and 3), a clinical assessment of ocular signs and symptoms was performed in both eyes, as well as pinhole visual acuity testing, biomicroscopy, and culture of the infected eye(s). An ophthalmoscopic examination was performed at study entry and on day 8. The primary efficacy outcome measures were clinical resolution and eradication of the baseline bacterial infection on day 8 in culture-confirmed patients. The safety evaluation included adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings in all patients who received at least 1 dose of active treatment or vehicle. The safety population consisted of 269 patients (mean [SD] age, 34.2 [22.3] years; 60.2% female; 82.5% white) with acute bacterial conjunctivitis. The culture-confirmed intent-to-treat population consisted of 118 patients (60 besifloxacin ophthalmic suspension, 58 vehicle). Significantly more patients receiving besifloxacin ophthalmic suspension than vehicle had clinical resolution of the baseline infection at visit 3 (44/60 [73.3%] vs 25/58 [43.1%], respectively; P < 0.001). Rates of bacterial eradication also were significantly greater with besifloxacin ophthalmic suspension compared

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…

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.

Comparison of Analytic Hierarchy Process, Catastrophe and Entropy techniques for evaluating groundwater prospect of hard-rock aquifer systems

NASA Astrophysics Data System (ADS)

Jenifer, M. Annie; Jha, Madan K.

2017-05-01

Groundwater is a treasured underground resource, which plays a central role in sustainable water management. However, it being hidden and dynamic in nature, its sustainable development and management calls for precise quantification of this precious resource at an appropriate scale. This study demonstrates the efficacy of three GIS-based multi-criteria decision analysis (MCDA) techniques, viz., Analytic Hierarchy Process (AHP), Catastrophe and Entropy in evaluating groundwater potential through a case study in hard-rock aquifer systems. Using satellite imagery and relevant field data, eight thematic layers (rainfall, land slope, drainage density, soil, lineament density, geology, proximity to surface water bodies and elevation) of the factors having significant influence on groundwater occurrence were prepared. These thematic layers and their features were assigned suitable weights based on the conceptual frameworks of AHP, Catastrophe and Entropy techniques and then they were integrated in the GIS environment to generate an integrated raster layer depicting groundwater potential index of the study area. The three groundwater prospect maps thus yielded by these MCDA techniques were verified using a novel approach (concept of 'Dynamic Groundwater Potential'). The validation results revealed that the groundwater potential predicted by the AHP technique has a pronounced accuracy of 87% compared to the Catastrophe (46% accuracy) and Entropy techniques (51% accuracy). It is concluded that the AHP technique is the most reliable for the assessment of groundwater resources followed by the Entropy method. The developed groundwater potential maps can serve as a scientific guideline for the cost-effective siting of wells and the effective planning of groundwater development at a catchment or basin scale.

Pre-injection of magnesium sulfate enhances the efficacy of ibutilide for the conversion of typical but not of atypical persistent atrial flutter.

PubMed

Steinwender, Clemens; Hönig, Simon; Kypta, Alexander; Kammler, Jürgen; Schmitt, Barbara; Leisch, Franz; Hofmann, Robert

2010-06-11

Ibutilide is a class III antiarrhythmic drug, frequently used for conversion of atrial fibrillation and flutter. Retrospective cohort evaluations found that intravenous application of magnesium enhances the efficacy of ibutilide for chemical conversion of these arrhythmias. This prospective study sought to investigate the effects of intravenously pre-injected magnesium on the conversion rate of ibutilide for typical and atypical atrial flutter. We performed a prospective, randomized, placebo-controlled study. Patients with typical atrial flutter (TAF) or atypical atrial flutter (AAF) were randomized to receive either 4 g of intravenous magnesium sulfate or placebo immediately before administration of a maximum dose of 2 mg of ibutilide fumarate. Continuous rhythm monitoring for 4 h provided information on conversion to sinus rhythm. QT interval durations were measured before randomization, after magnesium, as well as 30 min and 4 h after starting ibutilide infusion. We randomized 117 patients (58 with and 59 without pre-injection of magnesium; 65 with TAF and 52 with AAF). In patients with TAF, pre-injection of magnesium significantly improved the efficacy of ibutilide for conversion (85% with magnesium vs. 59% with placebo, p=0.017). In patients with AAF, no significant difference in conversion rates between patients receiving magnesium or placebo was detected (48% vs. 56%, p=0.189). Pre-injection of magnesium did not significantly influence the QT intervals at any time after administration of ibutilide. Pre-injection of magnesium significantly enhances the efficacy of ibutilide for the conversion of TAF but not of AAF. Copyright (c) 2008 Elsevier Ireland Ltd. All rights reserved.

COMPARED EFFICACY OF INTRA-ARTICULAR INJECTION OF METHYLPREDNISOLONE AND TRIAMCINOLONE.

PubMed

Buyuk, Abdul Fettah; Kilinc, Eray; Camurcu, Ismet Yalkin; Camur, Savas; Ucpunar, Hanifi; Kara, Adnan

2017-01-01

To compare the effect of two different corticosteroid types in bilateral and symmetrical knee osteoarthritis (OA). One hundred and twenty-six patients received injections of methylprednisolone acetate (MP) in one knee and triamcinolone hexacetonide (TH) in the contralateral knee. Patients were evaluated before injection and 2, 4, 8, 12, and 24 weeks after. Mean patient age was 68.5±9 years. Mean BMI was 26.3±2.6 kg/m 2 . At first admission, mean VAS score was 7.7±1.3 for the right side and 7.5±1.5 for the left side, and mean WOMAC score was 67.6±14.4. After bilateral intra-articular injection, VAS scores for both knees and WOMAC scores decreased significantly when initial scores were compared with 2, 4, 8, 12, and 24 weeks after injection (p<0.05). A statistically significant change was seen over time when VAS and WOMAC scores for 2, 4, 8, 12, and 24 weeks post-injection were compared to each other (p<0.05). No significant difference was seen between knee sides (p>0.05). MP and TH have similar efficacy in relieving pain and improving function. The efficacy of intra-articular corticosteroid injection peaks 2 weeks after injection and the effect continues until the 24 th week. Level of Evidence II, Comparative Prospective Study.

COMPARED EFFICACY OF INTRA-ARTICULAR INJECTION OF METHYLPREDNISOLONE AND TRIAMCINOLONE

PubMed Central

BUYUK, ABDUL FETTAH; KILINC, ERAY; CAMURCU, ISMET YALKIN; CAMUR, SAVAS; UCPUNAR, HANIFI; KARA, ADNAN

2017-01-01

ABSTRACT Objective: To compare the effect of two different corticosteroid types in bilateral and symmetrical knee osteoarthritis (OA). Methods: One hundred and twenty-six patients received injections of methylprednisolone acetate (MP) in one knee and triamcinolone hexacetonide (TH) in the contralateral knee. Patients were evaluated before injection and 2, 4, 8, 12, and 24 weeks after. Results: Mean patient age was 68.5±9 years. Mean BMI was 26.3±2.6 kg/m2. At first admission, mean VAS score was 7.7±1.3 for the right side and 7.5±1.5 for the left side, and mean WOMAC score was 67.6±14.4. After bilateral intra-articular injection, VAS scores for both knees and WOMAC scores decreased significantly when initial scores were compared with 2, 4, 8, 12, and 24 weeks after injection (p<0.05). A statistically significant change was seen over time when VAS and WOMAC scores for 2, 4, 8, 12, and 24 weeks post-injection were compared to each other (p<0.05). No significant difference was seen between knee sides (p>0.05). Conclusion: MP and TH have similar efficacy in relieving pain and improving function. The efficacy of intra-articular corticosteroid injection peaks 2 weeks after injection and the effect continues until the 24th week. Level of Evidence II, Comparative Prospective Study. PMID:29081706

Evaluation in the field of social services for minors: Measuring the efficacy of interventions in the Italian service for health protection and promotion.

PubMed

Iudici, Antonio; Gagliardo Corsi, Agnese

2017-04-01

This article presents the availment of a new Methodology for the efficacy evaluation of interventions in the field of social science: the Method of Computerized Textual Data Analysis (M.A.D.I.T.). In the beginning, we present some elements of the international and Italian legislation referred to the efficacy evaluation and about the child protection. Subsequently this work describes the process of efficacy evaluation of an intervention of minor protection delivered by a public Italian Service, the Minor and Family Service, MiFa. The MADIT Methodology is applied to the efficacy evaluation and it is interested in discursive repertoires, defined as "a linguistically intended mode of construction of finite reality". The aim of the research is to show, through the description of every step of the implementation of the Methodology based on text analysis, how is possible to notice if there are progress in the direction of the objective of intervention of child protection. The results describes how from a starting situation of "first appearance of psychiatric career" referred to the minor, the work of the psychologist of the Service MiFa has enabled to produce a shifting in the direction of objective of the intervention, that was "developing the competence of the minor to identify objectives". Through this work, we show how a rigorous methodology for assessing effectiveness may contribute to improve the quality of service of Minor Protection and may also be suitable for new fields of social science. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses☆

PubMed Central

Pinto-Fraga, José; Blázquez Arauzo, Francisco; Urbano Rodríguez, Rubén; González-García, María J.

2014-01-01

Purpose To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. Methods This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Results Twenty subjects (10 women, 10 men) (mean age, 27.7 ± 5.6 years; range, 20–41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p = 0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p = 0.18). The study MPDS received higher rates in comfort (study: 8.14 ± 1.09, control: 7.94 ± 0.92; p = 0.56) and satisfaction at day 30 (study: 8.63 ± 0.91, control: 8.29 ± 0.80; p = 0.19), however the scores were not significantly different with the control MPDS. Conclusions The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation. PMID:25649640

Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

PubMed

Pinto-Fraga, José; Blázquez Arauzo, Francisco; Urbano Rodríguez, Rubén; González-García, María J

2015-01-01

To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Twenty subjects (10 women, 10 men) (mean age, 27.7±5.6 years; range, 20-41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p=0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p=0.18). The study MPDS received higher rates in comfort (study: 8.14±1.09, control: 7.94±0.92; p=0.56) and satisfaction at day 30 (study: 8.63±0.91, control: 8.29±0.80; p=0.19), however the scores were not significantly different with the control MPDS. The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation. Copyright © 2014 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

Human antibody responses to the Anopheles salivary gSG6-P1 peptide: a novel tool for evaluating the efficacy of ITNs in malaria vector control.

PubMed

Drame, Papa Makhtar; Poinsignon, Anne; Besnard, Patrick; Cornelie, Sylvie; Le Mire, Jacques; Toto, Jean-Claude; Foumane, Vincent; Dos-Santos, Maria Adelaide; Sembène, Mbacké; Fortes, Filomeno; Simondon, Francois; Carnevale, Pierre; Remoue, Franck

2010-12-14

To optimize malaria control, WHO has prioritised the need for new indicators to evaluate the efficacy of malaria vector control strategies. The gSG6-P1 peptide from gSG6 protein of Anopheles gambiae salivary glands was previously designed as a specific salivary sequence of malaria vector species. It was shown that the quantification of human antibody (Ab) responses to Anopheles salivary proteins in general and especially to the gSG6-P1 peptide was a pertinent biomarker of human exposure to Anopheles. The present objective was to validate this indicator in the evaluation of the efficacy of Insecticide Treated Nets (ITNs). A longitudinal evaluation, including parasitological, entomological and immunological assessments, was conducted on children and adults from a malaria-endemic area before and after the introduction of ITNs. Significant decrease of anti-gSG6-P1 IgG response was observed just after the efficient ITNs use. Interestingly, specific IgG Ab level was especially pertinent to evaluate a short-time period of ITNs efficacy and at individual level. However, specific IgG rose back up within four months as correct ITN use waned. IgG responses to one salivary peptide could constitute a reliable biomarker for the evaluation of ITN efficacy, at short- and long-term use, and provide a valuable tool in malaria vector control based on a real measurement of human-vector contact.

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.

Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial.

PubMed

Aggarwal, Vivek; Singla, Mamta; Kabi, Debipada

2010-03-01

Anesthetic efficacy of inferior alveolar nerve block decreases in patients with irreversible pulpitis. It was hypothesized that premedication with nonsteroidal anti-inflammatory drugs might improve the success rates in patients with inflamed pulps. Sixty-nine adult volunteers who were actively experiencing pain participated in this prospective, randomized, double-blind study. The patients were divided into 3 groups on a random basis and were randomly given 1 of the 3 drugs including ibuprofen, ketorolac, and placebo 1 hour before anesthesia. All patients received standard inferior alveolar nerve block of 2% lidocaine with 1:200,000 epinephrine. Endodontic access preparation was initiated after 15 minutes of initial inferior alveolar nerve block. Pain during treatment was recorded by using a Heft Parker visual analog scale. Success was recorded as none or mild pain. Statistical analysis with nonparametric chi2 tests showed that placebo gave 29% success rate. Premedication with ibuprofen gave 27%, and premedication with ketorolac gave 39% success rate. There was no significant difference between the 3 groups. Preoperative administration of ibuprofen or ketorolac has no significant effect on success rate of inferior alveolar nerve block in patients with irreversible pulpitis. Copyright (c) 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

The effect of electronic networking on preservice elementary teachers' science teaching self-efficacy and attitude towards science teaching

NASA Astrophysics Data System (ADS)

Mathew, Nishi Mary

Preservice elementary teachers' science teaching efficacy and attitude towards science teaching are important determinants of whether and how they will teach science in their classrooms. Preservice teachers' understanding of science and science teaching experiences have an impact on their beliefs about their ability to teach science. This study had a quasi-experimental pretest-posttest control group design (N = 60). Preservice elementary teachers in this study were networked through the Internet (using e-mail, newsgroups, listserv, world wide web access and electronic mentoring) during their science methods class and student practicum. Electronic networking provides a social context in which to learn collaboratively, share and reflect upon science teaching experiences and practices, conduct tele-research effectively, and to meet the demands of student teaching through peer support. It was hoped that the activities over the electronic networks would provide them with positive and helpful science learning and teaching experiences. Self-efficacy was measured using a 23-item Likert scale instrument, the Science Teaching Efficacy Belief Instrument, Form-B (STEBI-B). Attitude towards science teaching was measured using the Revised Science Attitude Scale (RSAS). Analysis of covariance was used to analyze the data, with pretest scores as the covariate. Findings of this study revealed that prospective elementary teachers in the electronically networked group had better science teaching efficacy and personal science teaching efficacy as compared to the non-networked group of preservice elementary teachers. The science teaching outcome expectancy of prospective elementary teachers in the networked group was not greater than that of the prospective teachers in the non-networked group (at p < 0.05). Attitude towards science teaching was not significantly affected by networking. However, this is surmised to be related to the duration of the study. Information about the

Evaluation of antimicrobial efficacy of Aloe vera and its effectiveness in decontaminating gutta percha cones

PubMed Central

Athiban, Prakash P; Borthakur, Bikash Jyoti; Ganesan, S; Swathika, B

2012-01-01

Aim: The aim of this study was to evaluate the antimicrobial efficacy of Aloe vera and to determine its effectiveness in decontaminating gutta percha cones. Materials and Methods: 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. Results: 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. Conclusion: 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. PMID:22876011

Evaluation of calibration efficacy under different levels of uncertainty

DOE PAGES

Heo, Yeonsook; Graziano, Diane J.; Guzowski, Leah; ...

2014-06-10

This study examines how calibration performs under different levels of uncertainty in model input data. It specifically assesses the efficacy of Bayesian calibration to enhance the reliability of EnergyPlus model predictions. A Bayesian approach can be used to update uncertain values of parameters, given measured energy-use data, and to quantify the associated uncertainty.We assess the efficacy of Bayesian calibration under a controlled virtual-reality setup, which enables rigorous validation of the accuracy of calibration results in terms of both calibrated parameter values and model predictions. Case studies demonstrate the performance of Bayesian calibration of base models developed from audit data withmore » differing levels of detail in building design, usage, and operation.« less

Simulated real-time lunar volatiles prospecting with a rover-borne neutron spectrometer

NASA Astrophysics Data System (ADS)

Elphic, Richard C.; Heldmann, Jennifer L.; Marinova, Margarita M.; Colaprete, Anthony; Fritzler, Erin L.; McMurray, Robert E.; Morse, Stephanie; Roush, Ted L.; Stoker, Carol R.; Deans, Matthew C.; Smith, Trey F.

2015-05-01

In situ resource utilization (ISRU) may one day enable long duration lunar missions. But the efficacy of such an approach greatly depends on (1) physical and chemical makeup of the resource, and (2) the logistical cost of exploiting the resource. Establishing these key strategic factors requires prospecting: the capability of locating and characterizing potential resources. There is already considerable evidence from orbital and impact missions that the lunar poles harbor plausibly rich reservoirs of volatiles. The next step is to land on the Moon and assess the nature, “ore-grade”, and extractability of water ice and other materials. In support of this next step, a mission simulation was carried out on the island of Hawai'i in July of 2012. A robotic rover, provided by the Canadian Space Agency, carried several NASA ISRU-supporting instruments in a field test to address how such a mission might be carried out. This exercise was meant to test the ability to (a) locate and characterize volatiles, (b) acquire subsurface samples in a volatile-rich location, and (c) analyze the form and composition of the volatiles to determine their utility. This paper describes the successful demonstration of neutron spectroscopy as a prospecting and decision support system to locate and evaluate potential ISRU targets in the field exercise.

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...

A prospective evaluation of early detection biomarkers for ovarian cancer in the European EPIC cohort

PubMed Central

Terry, Kathryn L.; Schock, Helena; Fortner, Renée T.; Hüsing, Anika; Fichorova, Raina N.; Yamamoto, Hidemi S.; Vitonis, Allison F.; Johnson, Theron; Overvad, Kim; Tjønneland, Anne; Boutron-Ruault, Marie-Christine; Mesrine, Sylvie; Severi, Gianluca; Dossus, Laure; Rinaldi, Sabina; Boeing, Heiner; Benetou, Vassiliki; Lagiou, Pagona; Trichopoulou, Antonia; Krogh, Vittorio; Kuhn, Elisabetta; Panico, Salvatore; Bueno-de-Mesquita, H. Bas; Onland-Moret, N. Charlotte; Peeters, Petra H.; Gram, Inger Torhild; Weiderpass, Elisabete; Duell, Eric J.; Sanchez, Maria-Jose; Ardanaz, Eva; Etxezarreta, Nerea; Navarro, Carmen; Idahl, Annika; Lundin, Eva; Jirström, Karin; Manjer, Jonas; Wareham, Nicholas J.; Khaw, Kay-Tee; Byrne, Karl Smith; Travis, Ruth C.; Gunter, Marc J.; Merritt, Melissa A.; Riboli, Elio; Cramer, Daniel W.; Kaaks, Rudolf

2016-01-01

Purpose About 60% of ovarian cancers are diagnosed at late stage, when 5-year survival is less than 30% in contrast to 90% for local disease. This has prompted search for early detection biomarkers. For initial testing, specimens taken months or years before ovarian cancer diagnosis are the best source of information to evaluate early detection biomarkers. Here we evaluate the most promising ovarian cancer screening biomarkers in prospectively collected samples from the European Prospective Investigation into Cancer and Nutrition study. Experimental Design We measured CA125, HE4, CA72.4 and CA15.3 in 810 invasive epithelial ovarian cancer cases and 1,939 controls. We calculated the sensitivity at 95% and 98% specificity as well as Area under the Receiver Operator Curve (C-statistic) for each marker individually and in combination. Additionally, we evaluated marker performance by stage at diagnosis and time between blood draw and diagnosis. Results We observed the best discrimination between cases and controls within six months of diagnosis for CA125 (C-statistic=0.92), then HE4 (0.84), CA72.4 (0.77), and CA15.3 (0.73). Marker performance declined with longer time between blood draw and diagnosis and for earlier staged disease. However, assessment of discriminatory ability at early stage was limited by small numbers. Combinations of markers performed modestly, but significantly better than any single marker. Conclusions CA125 remains the single best marker for the early detection of invasive epithelial ovarian cancer, but can be slightly improved by combining with other markers. Identifying novel markers for ovarian cancer will require studies including larger numbers of early stage cases. PMID:27060155

Psychometric evaluation of the Korean version of the Diabetes Self-efficacy Scale among South Korean older adults with type 2 diabetes.

PubMed

Chang, Sun Ju; Song, Misoon; Im, Eun-Ok

2014-08-01

To evaluate the psychometric properties (reliability and validity) of the Korean version of the Diabetes Self-efficacy Scale among South Korean older adults with type 2 diabetes mellitus. Self-efficacy has been reported to be a key component of enhancing diabetes self-management, and many healthcare providers have paid attention to the instruments to accurately measure self-efficacy as related to diabetes self-management. A psychometric test of an instrument measuring self-efficacy as related to diabetes self-management. A total of 278 Korean older adults with type 2 diabetes were recruited in one senior centre in Seoul, South Korea. The instrument included the Diabetes Self-efficacy Scale and the summary of the Diabetes Self-care Activities. Item analyses, reliability including internal consistency and stability, and validity including exploratory factor analysis, confirmatory factor analysis, and hypothesised relationships test were used to examine the psychometric properties of the Korean version of the Diabetes Self-efficacy Scale. The item-total correlation coefficients of all items were >0·30 and ranged from 0·47-0·73. The coefficient alpha for the internal consistency was 0·89, and the intraclass correlation coefficient for the stability was 0·90. Two factors were extracted from the exploratory factor analysis (factor 1, self-efficacy for diet-related self-management behaviours; factor 2, self-efficacy for diabetes self-management behaviours except diet), and the two-factor model for the confirmatory factor analysis had good fitness indices. The diabetes self-efficacy scores were positively correlated with the level of diabetes self-management. The findings supported that the Korean version of the Diabetes Self-efficacy Scale was reliable and valid in measuring self-efficacy as related to diabetes self-management in Korean older adults with type 2 diabetes. The Korean version of the Diabetes Self-efficacy Scale can allow healthcare providers to

Extracorporeal shockwave myocardial therapy is efficacious in improving symptoms in patients with refractory angina pectoris--a multicenter study.

PubMed

Prasad, Megha; Wan Ahmad, Wan Azman; Sukmawan, Renan; Magsombol, Edward-Bengie L; Cassar, Andrew; Vinshtok, Yuri; Ismail, Muhammad Dzafir; Mahmood Zuhdi, Ahmad Syadi; Locnen, Sue Ann; Jimenez, Rodney; Callleja, Homobono; Lerman, Amir

2015-05-01

Medically refractory angina remains a significant health concern despite major advances in revascularization techniques and emerging medical therapies. We aimed to determine the safety and efficacy of extracorporeal shockwave myocardial therapy (ESMT) in managing angina pectoris. A single-arm multicenter prospective study was designed aiming to determine the safety and efficacy of ESMT. Patients of functional Canadian Cardiovascular Society class II-IV, despite stable and optimal medical management, with documented myocardial segments with reversible ischemia and/or hibernation on the basis of echocardiography/single-photon emission computerized tomography (SPECT) were enrolled from 2010 to 2012. A total of 111 patients were enrolled, 33 from Indonesia, 21 from Malaysia, and 57 from Philippines. Patients underwent nine cycles of ESMT over 9 weeks. Patients were followed up for 3-6 months after ESMT treatment. During follow-up, patients were subjected to clinical evaluation, the Seattle Angina Questionnaire, assessment of nitrate intake, the 6-min walk test, echocardiography, and SPECT. The mean age of the population was 62.9±10.9 years. The summed difference score on pharmacologically induced stress SPECT improved from 9.53±17.87 at baseline to 7.77±11.83 at follow-up (P=0.0086). Improvement in the total Seattle Angina Questionnaire score was seen in 83% of patients (P<0.0001). Sublingual nitroglycerin use significantly decreased (1.14±1.01 tablets per week at baseline to 0.52±0.68 tablets per week at follow-up; P=0.0215). There were no changes in left ventricular function on echocardiography (0.33±9.97, P=0.93). The Canadian Cardiovascular Society score improved in 74.1% of patients. This multicenter prospective trial demonstrated that ESMT is both a safe and an efficacious means of managing medically refractory angina.

A Prospective, Observational Study to Evaluate the Role of Gabapentin as Preventive Analgesic in Thyroidectomy under General Anesthesia.

PubMed

Hema, Vadakkoot Raghavan; Ramadas, Konnanath Thekkethil; Biji, Kannammadathy Poulose; Indu, Suseela; Arun, Aravind

2017-01-01

Effective management of postoperative pain is a part of well-organized perioperative care, which helps in reduced morbidity and improved patient satisfaction. Preventive analgesia can reduce acute and chronic pain by blocking the noxious inputs to pain pathways, preventing sensitization. Studies have reported efficacy of gabapentin as a preventive analgesic in perioperative pain. In this study, we aimed to determine whether preoperative gabapentin reduced postoperative pain and tramadol consumption after thyroidectomy under general anesthesia. Sixty patients scheduled for thyroidectomy were allocated to two groups of thirty each for this prospective, observational study. Patients in Group A and Group B received oral gabapentin 600 mg (6 × 10 -4 kg) and diazepam 10 mg (1 × 10 -5 kg), respectively, 2 h prior to surgery. Tramadol was given as rescue analgesic for postoperative pain with a verbal rating score of two. The analgesic efficacy of preoperative gabapentin was assessed in terms of postoperative pain scores at rest or swallowing, time to first rescue analgesic, and total tramadol consumption for 24 h. Ramsay sedation score and side effects of drug were also looked into. Postoperative pain scores and total tramadol consumption were significantly lower in Group A during 24 h ( P = 0.00). Time to first rescue analgesic was significantly prolonged in Group A ( P = 0.001). Side effects were comparable. Oral gabapentin is effective as a preventive analgesic in reducing postoperative pain and tramadol consumption after thyroidectomy under general anesthesia.

Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study.

PubMed

Eckmann, Jason D; Ravi, Karthik; Katzka, David A; Davis, Dawn R; See, Jacalyn A; Geno, Debra R; Kryzer, Lori A; Alexander, Jeffrey A

2018-03-01

Atopy patch testing (APT) has shown potential for predicting dietary food triggers in studies of children and adolescents with eosinophilic esophagitis (EoE). To assess the efficacy of APT in adults with EoE. We conducted a prospective open-label pilot study of patients ≥ 18 years old with diagnosis of EoE at Mayo Clinic in Rochester, Minnesota, from November 2014 to January 2016. All patients underwent patch testing using intact food products, followed by a six food elimination diet and stepwise food reintroduction. Response to elimination diet was assessed with serial endoscopy with biopsies as well as clinical symptoms. APT results were directly compared to elimination diet results for assessment of efficacy. Correlation between clinical symptoms, endoscopic score, and histology was also qualitatively evaluated. Fifty percent of the patients had a positive APT, while only 16% had an APT result confirmed histologically during food reintroduction. Sensitivity of APT was calculated to be 5.9%, with specificity of 92.0%. Furthermore, we found significant qualitative inter-patient heterogeneity in the correlation between clinical symptoms, EREFS score, and histology. APT does not reliably predict food triggers identified by food elimination diet in adult patients with EoE. As a result, APT does not have a clear role in the evaluation of patients with EoE.

Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial.

PubMed

Saha, Suparna Ganguly; Jain, Sohini; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

2016-02-01

It is generally accepted that achieving complete anaesthesia with an Inferior Alveolar Nerve Block (IANB) in mandibular molars with symptomatic irreversible pulpitis is more challenging than for other teeth. Therefore, administration of Non-Steroidal Anti-Inflammatory Agents (NSAIDs) 1 hour prior to anaesthetic administration has been proposed as a means to increase the efficacy of the IANB in such patients. The purpose of this prospective, double-blind, randomized clinical trial was to determine the effect of administration of oral premedication with ketorolac (KETO) and diclofenac potassium (DP) on the efficacy of IANB in patients with irreversible pulpitis. One hundred and fifty patients with irreversible pulpitis were evaluated preoperatively for pain using Heft Parker visual analogue scale, after which they were randomly divided into three groups. The subjects received identical tablets of ketorolac, diclofenac pottasium or cellulose powder (placebo), 1 hour prior to administration of IANB with 2% lidocaine containing 1:200 000 epinephrine. Lip numbness as well as positive and negative responses to cold test were ascertained. Additionally pain score of each patient was recorded during cavity preparation and root canal instrumentation. Success was defined as the absence of pain or mild pain based on the visual analog scale readings. The data was analysed using One-Way Anova, Post-Hoc Tukey pair wise, Paired T - Test and chi-square test. Trial Registery Number is 4722/2015 for this clinical trial study. There were no significant differences with respect to age (p =0.098), gender (p = 0.801) and pre-VAS score (DP-KETO p=0.645, PLAC-KETO p =0.964, PLAC-DP p = 0.801) between the three groups. All patients had subjective lip anaesthesia with the IAN blocks. Patients of all the three groups reported a significant decrease in active pain after local anaesthesia (p< 0.05). The post injection VAS Score was least in group 1 (KETO) followed by group II (DP) & maximum in

Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

PubMed Central

Saha, Suparna Ganguly; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

2016-01-01

Introduction It is generally accepted that achieving complete anaesthesia with an Inferior Alveolar Nerve Block (IANB) in mandibular molars with symptomatic irreversible pulpitis is more challenging than for other teeth. Therefore, administration of Non-Steroidal Anti-Inflammatory Agents (NSAIDs) 1 hour prior to anaesthetic administration has been proposed as a means to increase the efficacy of the IANB in such patients. Aim The purpose of this prospective, double-blind, randomized clinical trial was to determine the effect of administration of oral premedication with ketorolac (KETO) and diclofenac potassium (DP) on the efficacy of IANB in patients with irreversible pulpitis. Materials and Methods One hundred and fifty patients with irreversible pulpitis were evaluated preoperatively for pain using Heft Parker visual analogue scale, after which they were randomly divided into three groups. The subjects received identical tablets of ketorolac, diclofenac pottasium or cellulose powder (placebo), 1 hour prior to administration of IANB with 2% lidocaine containing 1:200 000 epinephrine. Lip numbness as well as positive and negative responses to cold test were ascertained. Additionally pain score of each patient was recorded during cavity preparation and root canal instrumentation. Success was defined as the absence of pain or mild pain based on the visual analog scale readings. The data was analysed using One-Way Anova, Post-Hoc Tukey pair wise, Paired T – Test and chi-square test. Trial Registery Number is 4722/2015 for this clinical trial study. Results There were no significant differences with respect to age (p =0.098), gender (p = 0.801) and pre-VAS score (DP-KETO p=0.645, PLAC-KETO p =0.964, PLAC-DP p = 0.801) between the three groups. All patients had subjective lip anaesthesia with the IAN blocks. Patients of all the three groups reported a significant decrease in active pain after local anaesthesia (p< 0.05). The post injection VAS Score was least in group

Exploring Instructional Strategies to Develop Prospective Elementary Teachers' Children's Literature Book Evaluation Skills for Science, Ecology and Environmental Education

ERIC Educational Resources Information Center

Hug, J. William

2010-01-01

This article is an auto-ethnographic account of the development of a children's literature book critique assignment by a science teacher educator sharing instructional dilemmas and pedagogical responses. Prospective elementary teachers enrolled in an elementary school science teaching methods course in the US selected and evaluated children's…

Evaluation of total alloplastic temporo-mandibular joint replacement with two different types of prostheses: A three-year prospective study.

PubMed

Gonzalez-Perez, L-M; Gonzalez-Perez-Somarriba, B; Centeno, G; Vallellano, C; Montes-Carmona, J-F

2016-11-01

Temporo-Mandibular Joint (TMJ) replacement has been used clinically for years. The objective of this study was to evaluate outcomes achieved in patients with two different categories of TMJ prostheses. All patients who had a TMJ replacement (TMJR) implanted during the study period from 2006 through 2012 were included in this 3-year prospective study. All procedures were performed using the Biomet Microfixation TMJ Replacement System, and all involved replacing both the skull base component (glenoid fossa) and the mandibular condyle. Fifty-seven patients (38 females and 19 males), involving 75 TMJs with severe disease requiring reconstruction (39 unilateral, 18 bilateral) were operated on consecutively, and 68 stock prostheses and 7 custom-made prostheses were implanted. The mean age at surgery was 52.6±11.5 years in the stock group and 51.8±11.7 years in the custom-made group. In the stock group, after three years of TMJR, results showed a reduction in pain intensity from 6.4±1.4 to 1.6±1.2 (p<0.001), and an improvement in jaw opening from 2.7±0.9 cm to 4.2±0.7 cm (p<0.001). In the custom-made group, after three years of TMJR, results showed a reduction in pain intensity from 6.0±1.6 to 2.2±0.4 (p<0.001), and an improvement in jaw opening from 1.5±0.5 cm to 4.3±0.6 cm (p<0.001). No statistically significant differences between two groups were detected. The results of this three-year prospective study support the surgical placement of TMJ prostheses (stock prosthetic, and custom-made systems), and show that the approach is efficacious and safe, reduces pain, and improves maximum mouth opening movement, with few complications. As such, TMJR represents a viable technique and a stable long-term solution for cranio-mandibular reconstruction in patients with irreversible end-stage TMJ disease. Comparing stock and custom-made groups, no statistically significant differences were detected with respect to pain intensity reduction and maximum mouth opening

Influence of bariatric surgery on quality of life, body image, and general self-efficacy within 6 and 24 months-a prospective cohort study.

PubMed

Nickel, Felix; Schmidt, Lukas; Bruckner, Thomas; Büchler, Markus W; Müller-Stich, Beat-Peter; Fischer, Lars

2017-02-01

It has been proven that bariatric surgery affects weight loss. Patients with morbid obesity have a significantly lower quality of life (QOL) and body image compared with the general population. To evaluate QOL, body image, and general self-efficacy (GSE) in patients with morbid obesity undergoing bariatric surgery within clinical parameters. Monocentric, prospective, longitudinal cohort study. Patients completed the short form 36 (SF-36) for QOL, body image questionnaire, and GSE scale 3 times: before surgery and within 6 months and 24 months after surgery. Influence of gender, age, and type of procedure, either laparoscopic sleeve gastrectomy (SG) or laparoscopic Roux-en-Y gastric bypass, were analyzed. Thirty patients completed the questionnaires before and within 6 and 24 months after surgery. SF-36 physical summary score improved significantly from 34.3±11.0 before surgery to 46.0±10.4 within 6 months (P<.001) and to 49.8±8.2 within 24 months (P<.001) after surgery. SF-36 mental summary score improved significantly from 42.1±14.7 before surgery to 52.3±8.4 within 6 months (P<.001) and to 48.4±12.2 within 24 months (P<.001) after surgery. There were no significant differences between gender, age, and type of operation. Body image and GSE improved significantly after bariatric surgery (P<.001), and both correlated to the SF-36 mental summary score. QOL, body image, and GSE improved significantly within 6 months and remained stable within 24 months after bariatric surgery. Improvements were independent of gender, age, and type of operation. Mental QOL was influenced by body image and GSE. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. 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

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.

Acceptability and initial efficacy of education for teen mothers.

PubMed

Logsdon, M Cynthia; Davis, Deborah Winders; Stikes, Reetta; Ratterman, Rachel; Ryan, Lesa; Myers, John

2015-01-01

Educational materials used by healthcare agencies frequently do not follow national health guidelines for plain talk. Adolescent mothers are a vulnerable population in need of accurate and accessible health information to promote their own health and that of their baby. The aims of our study were to: Determine acceptability of simple, written educational pamphlets to adolescent mothers; Determine efficacy of simple, written educational pamphlets in improving an adolescent mother's knowledge related to breastfeeding, infant care, postpartum depression, and mother-infant relationship; Determine if higher knowledge scores are maintained after a 2-week period; and Determine general parenting health literacy of adolescent mothers. Using a prospective, experimental design, students enrolled in a teen parent program (n = 123) completed a pretest and The Parent Health Literacy Activities Test (PHLAT), read the health educational materials, and completed an immediate posttest of knowledge and acceptability. Two weeks later, the same participants completed a second posttest of knowledge. Adolescent mothers found the intervention (simple, written educational materials) to be acceptable. The intervention was initially effective in improving knowledge scores in all four content areas. However, knowledge was not retained and scores were not significantly different from baseline at the 2-week assessment. The mean health literacy of the adolescent mothers was poor. A booster session may be necessary for knowledge retention. Other methods of education should be studied to evaluate efficacy for adolescent mothers' knowledge retention of important health information.

Safety and efficacy of overnight orthokeratology in myopic children.

PubMed

Mika, Renée; Morgan, Bruce; Cron, Michael; Lotoczky, Josh; Pole, John

2007-05-01

This prospective case series was conducted to describe the safety and efficacy of orthokeratology with the Emerald Contact Lens for Overnight Orthokeratology (Oprifocon A; Euclid Systems Corporation, Herndon, Virginia) among young myopes. Twenty subjects (ages 10 to 16) were enrolled in the 6-month pilot study. Subjects were fit empirically with overnight orthokeratology lenses and evaluated at 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months. Sixteen subjects completed the study. The mean baseline spherical equivalent refraction (SER) was -2.06 diopters (D) (+/-0.75). The mean SER at 6 months was -0.16 D (+/-0.38). The mean baseline uncorrected acuity was 0.78 (+/-0.28) logarithmic minimum angle of resolution (logMAR) equivalent (20/100 Snellen). The mean logMAR equivalent at 6 months was -0.03 +/- 0.12 (<20/20 Snellen). On average, 40% of eyes showed some type of corneal staining between the 1-week and 6-month visits. No serious adverse events occurred during the study. In contrast to previously published studies that reported maximum results at 2 weeks, subjects reached maximum reduction in myopia at the 1-week visit and, on average, obtained a 92.2% reduction in spherical equivalent refractive error at 6 months. This pilot study lends to a growing body of evidence that short-term correction of mild to moderate myopia with overnight orthokeratology is safe and efficacious in children and adolescents.

A prospective evaluation of the ligation of the intersphincteric tract procedure for complex anal fistula in patients with Crohn's disease.

PubMed

Gingold, Daniel S; Murrell, Zuri A; Fleshner, Phillip R

2014-12-01

To evaluate 2- and 12-month outcomes after ligation of the intersphincteric fistula tract (LIFT) in Crohn's disease (CD). Surgical approaches to perianal fistulas in CD are frequently ineffective and hampered by concerns over adequate wound healing and sphincter injury. The efficacy of LIFT in CD patients is unknown. Consecutive cases of CD patients with transsphincteric fistulas were prospectively analyzed. Fistula healing and 2 validated quality-of-life indices were assessed. Fifteen CD patients (9 women; mean age = 34.8 years) were identified. Location of the fistula was lateral (n = 10; 67%) or midline (n = 5; 33%). LIFT site healing was seen in 9 patients (60%) at 2-month follow-up. No patient developed fecal incontinence. LIFT site healing was seen in 8 of the 12 patients (67%) with complete 12-month follow-up. Significant factors for long-term LIFT site healing were lateral versus midline location (P = 0.02) and longer mean fistula length (P = 0.02). Patients who had successful operations significantly improved both their mean Wexner Perianal Crohn's Disease Activity Index and McMaster Perianal Crohn's Disease Activity Index quality-of-life scores at 2-month follow-up (14.0-3.8, P = 0.001, and 10.4-1.8, P = 0.0001, respectively). CD-associated anal fistulas may be treated with LIFT. This surgical procedure is a safe, outpatient procedure that minimizes both perianal wound creation and sphincter injury.

Randomized, Prospective, Three-Arm Study to Confirm the Auditory Safety and Efficacy of Artemether-Lumefantrine in Colombian Patients with Uncomplicated Plasmodium falciparum Malaria

PubMed Central

Carrasquilla, Gabriel; Barón, Clemencia; Monsell, Edwin M.; Cousin, Marc; Walter, Verena; Lefèvre, Gilbert; Sander, Oliver; Fisher, Laurel M.

2012-01-01

The safety of artemether-lumefantrine in patients with acute, uncomplicated Plasmodium falciparum malaria was investigated prospectively using the auditory brainstem response (ABR) and pure-tone thresholds. Secondary outcomes included polymerase chain reaction-corrected cure rates. Patients were randomly assigned in a 3:1:1 ratio to either artemether-lumefantrine (N = 159), atovaquone-proguanil (N = 53), or artesunate-mefloquine (N = 53). The null hypothesis (primary outcome), claiming that the percentage of patients with a baseline to Day-7 ABR Wave III latency increase of > 0.30 msec is ≥ 15% after administration of artemether-lumefantrine, was rejected; 2.6% of patients (95% confidence interval: 0.7–6.6) exceeded 0.30 msec, i.e., significantly below 15% (P < 0.0001). A model-based analysis found no apparent relationship between drug exposure and ABR change. In all three groups, average improvements (2–4 dB) in pure-tone thresholds were observed, and polymerase chain reaction-corrected cure rates were > 95% to Day 42. The results support the continued safe and efficacious use of artemether-lumefantrine in uncomplicated falciparum malaria. PMID:22232454

Randomized, prospective, three-arm study to confirm the auditory safety and efficacy of artemether-lumefantrine in Colombian patients with uncomplicated Plasmodium falciparum malaria.

PubMed

Carrasquilla, Gabriel; Barón, Clemencia; Monsell, Edwin M; Cousin, Marc; Walter, Verena; Lefèvre, Gilbert; Sander, Oliver; Fisher, Laurel M

2012-01-01

The safety of artemether-lumefantrine in patients with acute, uncomplicated Plasmodium falciparum malaria was investigated prospectively using the auditory brainstem response (ABR) and pure-tone thresholds. Secondary outcomes included polymerase chain reaction-corrected cure rates. Patients were randomly assigned in a 3:1:1 ratio to either artemether-lumefantrine (N = 159), atovaquone-proguanil (N = 53), or artesunate-mefloquine (N = 53). The null hypothesis (primary outcome), claiming that the percentage of patients with a baseline to Day-7 ABR Wave III latency increase of > 0.30 msec is ≥ 15% after administration of artemether-lumefantrine, was rejected; 2.6% of patients (95% confidence interval: 0.7-6.6) exceeded 0.30 msec, i.e., significantly below 15% (P < 0.0001). A model-based analysis found no apparent relationship between drug exposure and ABR change. In all three groups, average improvements (2-4 dB) in pure-tone thresholds were observed, and polymerase chain reaction-corrected cure rates were > 95% to Day 42. The results support the continued safe and efficacious use of artemether-lumefantrine in uncomplicated falciparum malaria.

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.

Magnetic resonance neurography and diffusion tensor imaging: origins, history, and clinical impact of the first 50,000 cases with an assessment of efficacy and utility in a prospective 5000-patient study group.

PubMed

Filler, Aaron

2009-10-01

Methods were invented that made it possible to image peripheral nerves in the body and to image neural tracts in the brain. The history, physical basis, and dyadic tensor concept underlying the methods are reviewed. Over a 15-year period, these techniques-magnetic resonance neurography (MRN) and diffusion tensor imaging-were deployed in the clinical and research community in more than 2500 published research reports and applied to approximately 50,000 patients. Within this group, approximately 5000 patients having MRN were carefully tracked on a prospective basis. A uniform Neurography imaging methodology was applied in the study group, and all images were reviewed and registered by referral source, clinical indication, efficacy of imaging, and quality. Various classes of image findings were identified and subjected to a variety of small targeted prospective outcome studies. Those findings demonstrated to be clinically significant were then tracked in the larger clinical volume data set. MRN demonstrates mechanical distortion of nerves, hyperintensity consistent with nerve irritation, nerve swelling, discontinuity, relations of nerves to masses, and image features revealing distortion of nerves at entrapment points. These findings are often clinically relevant and warrant full consideration in the diagnostic process. They result in specific pathological diagnoses that are comparable to electrodiagnostic testing in clinical efficacy. A review of clinical outcome studies with diffusion tensor imaging also shows convincing utility. MRN and diffusion tensor imaging neural tract imaging have been validated as indispensable clinical diagnostic methods that provide reliable anatomic pathological information. There is no alternative diagnostic method in many situations. With the elapsing of 15 years, tens of thousands of imaging studies, and thousands of publications, these methods should no longer be considered experimental.

Efficacy and tolerability of preservative-free eye drops containing a fixed combination of dorzolamide and timolol in glaucoma patients.

PubMed

Renieri, Giulia; Führer, Katrin; Scheithe, Karl; Lorenz, Katrin; Pfeiffer, Norbert; Thieme, Hagen

2010-12-01

To evaluate the efficacy and tolerability of preservative-free eye drops (dorzolamide/timolol) in routine management of preservative-sensitive glaucoma patients. Data from 2,298 glaucoma patients requiring intraocular pressure (IOP) reduction and suffering from intolerance to benzalkonium chloride or active agents of previously used eye drops were valid for baseline and safety analysis in this prospective, open, noncomparative, multicenter, noninterventional study. Patients were treated with preservative-free dorzolamide/timolol eye drops for 12 weeks. Main efficacy endpoint was IOP reduction after 12 weeks of treatment. Two thousand forty-nine patients were considered for efficacy analysis. Tolerability was assessed by evaluating adverse drug reactions. Mean baseline IOP was 20.8 mmHg. Baseline IOP was reduced to 16.7 mmHg after 12 weeks of treatment corresponding to a mean absolute (percent) change of -4.1 mmHg (-17.3%). The proportion of patients with IOP ≤21 mmHg increased from 59.9% at baseline to 94.6% after 12 weeks. The most frequently reported ocular adverse drug reactions were burning eyes (2.4%) and hyperemia (0.9%). Local tolerability improved in 79.3% of patients compared to their previous glaucoma therapy. This observational study confirms the IOP lowering effect of preservative-free eye drops containing the fixed combination of dorzolamide/timolol in a large patient's population. The drug was well tolerated and improved the local tolerability in the vast majority of patients.

Efficacy and tolerability of paliperidone ER in patients with unsatisfactorily controlled schizophrenia by other antipsychotics: a flexible-dose approach

PubMed Central

Mauri, Massimo C.; Adami, Marina; Reggiardo, Giorgio; Giulio, Corrivetti

2015-01-01

This study evaluates the effectiveness of paliperidone ER in patients with symptomatic but not highly acute schizophrenia in terms of efficacy, safety, and patients’ perception of their social functioning and well-being. This is a multicenter, open-label prospective study with a flexible-dose approach; 133 patients were enrolled and followed for 13 weeks after switching to paliperidone ER. Outcome efficacy measures were as follows: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity (CGI-S) scale, and the Personal and Social Performance (PSP) scale; in addition, the Subjective Well-being under Neuroleptics (SWN-20) scale, the Drug Attitude Inventory (DAI-30), and the sleep evaluation scale were used. Symptom Rating Scale (ESRS), adverse events, and subjective side effects were recorded. 118/133(88.7%) patients completed the study. The mean PANSS score decreased (88.98±10.09 to 66.52±16.29; P<0.001); 40.5% of the patients achieved improvement of at least 30%. PSP and CGI-S scores as well as DAI-30 and SWN-20 decreased (P<0.001). ESRS (P<0.001) decreased significantly from the baseline. Throughout the trial, no deaths occurred and only one serious adverse event was reported. Paliperidone ER has proved to be efficacious, safe, and well tolerated also with this approach more closely resembling actual clinical practice. Patient-relevant outcome parameters such as social functioning and quality of life improved, which is crucial for treatment adherence in clinical practice. PMID:26230269

Efficacy and tolerability of paliperidone ER in patients with unsatisfactorily controlled schizophrenia by other antipsychotics: a flexible-dose approach.

PubMed

Mauri, Mauro; Mauri, Massimo C; Adami, Marina; Reggiardo, Giorgio; Giulio, Corrivetti

2015-11-01

This study evaluates the effectiveness of paliperidone ER in patients with symptomatic but not highly acute schizophrenia in terms of efficacy, safety, and patients' perception of their social functioning and well-being. This is a multicenter, open-label prospective study with a flexible-dose approach; 133 patients were enrolled and followed for 13 weeks after switching to paliperidone ER. Outcome efficacy measures were as follows: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity (CGI-S) scale, and the Personal and Social Performance (PSP) scale; in addition, the Subjective Well-being under Neuroleptics (SWN-20) scale, the Drug Attitude Inventory (DAI-30), and the sleep evaluation scale were used. Symptom Rating Scale (ESRS), adverse events, and subjective side effects were recorded. 118/133(88.7%) patients completed the study. The mean PANSS score decreased (88.98 ± 10.09 to 66.52 ± 16.29; P < 0.001); 40.5% of the patients achieved improvement of at least 30%. PSP and CGI-S scores as well as DAI-30 and SWN-20 decreased (P < 0.001). ESRS (P < 0.001) decreased significantly from the baseline. Throughout the trial, no deaths occurred and only one serious adverse event was reported. Paliperidone ER has proved to be efficacious, safe, and well tolerated also with this approach more closely resembling actual clinical practice. Patient-relevant outcome parameters such as social functioning and quality of life improved, which is crucial for treatment adherence in clinical practice.

Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

PubMed Central

2012-01-01

This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems. PMID:22583520

Technology Efficacy in Active Prosthetic Knees for Transfemoral Amputees: A Quantitative Evaluation

PubMed Central

El-Sayed, Amr M.; 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. PMID:25110727

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.

Evaluating the efficacy of DNA differential extraction methods for sexual assault evidence.

PubMed

Klein, Sonja B; Buoncristiani, Martin R

2017-07-01

Analysis of sexual assault evidence, often a mixture of spermatozoa and victim epithelial cells, represents a significant portion of a forensic DNA laboratory's case load. Successful genotyping of sperm DNA from these mixed cell samples, particularly with low amounts of sperm, depends on maximizing sperm DNA recovery and minimizing non-sperm DNA carryover. For evaluating the efficacy of the differential extraction, we present a method which uses a Separation Potential Ratio (SPRED) to consider both sperm DNA recovery and non-sperm DNA removal as variables for determining separation efficiency. In addition, we describe how the ratio of male-to-female DNA in the sperm fraction may be estimated by using the SPRED of the differential extraction method in conjunction with the estimated ratio of male-to-female DNA initially present on the mixed swab. This approach may be useful for evaluating or modifying differential extraction methods, as we demonstrate by comparing experimental results obtained from the traditional differential extraction and the Erase Sperm Isolation Kit (PTC © ) procedures. Copyright © 2017 Elsevier B.V. All rights reserved.

Using a mathematical model to evaluate the efficacy of TB control measures.

PubMed Central

Gammaitoni, L.; Nucci, M. C.

1997-01-01

We evaluated the efficacy of recommended tuberculosis (TB) infection control measures by using a deterministic mathematical model for airborne contagion. We examined the percentage of purified protein derivative conversions under various exposure conditions, environmental controlstrategies, and respiratory protective devices. We conclude that environmental control cannot eliminate the risk for TB transmission during high-risk procedures; respiratory protective devices, and particularly high-efficiency particulate air masks, may provide nearly complete protection if used with air filtration or ultraviolet irradiation. Nevertheless, the efficiency of these control measures decreases as the infectivity of the source case increases. Therefore, administrative control measures (e.g., indentifying and isolating patients with infectious TB) are the most effective because they substantially reduce the rate of infection. PMID:9284378

Formative Research regarding Kidney Disease Health Information in a Latino American Sample: Associations among Message Frame, Threat, Efficacy, Message Effectiveness, and Behavioral Intention

ERIC Educational Resources Information Center

Maguire, Katheryn C.; Gardner, Jay; Sopory, Pradeep; Jian, Guowei; Roach, Marcia; Amschlinger, Joe; Moreno, Marcia; Pettey, Gary; Piccone, Gianfranco

2010-01-01

Using prospect theory and the extended parallel process model, this study examined the effect of gain/loss message framing on perceptions of severity, susceptibility, response efficacy, and self efficacy (derived from the extended parallel process model), as well as perception of message effectiveness and behavioral intention in a community based…

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…

Use of an alpha lipoic, methylsulfonylmethane and bromelain dietary supplement (Opera®) for chemotherapy-induced peripheral neuropathy management, a prospective study.

PubMed

Desideri, Isacco; Francolini, Giulio; Becherini, Carlotta; Terziani, Francesca; Delli Paoli, Camilla; Olmetto, Emanuela; Loi, Mauro; Perna, Marco; Meattini, Icro; Scotti, Vieri; Greto, Daniela; Bonomo, Pierluigi; Sulprizio, Susanna; Livi, Lorenzo

2017-03-01

Chemotherapy-induced peripheral neuropathy (CIPN) is a major clinical problem associated with a number of cytotoxic agents. OPERA ® (GAMFARMA srl, Milan, Italy) is a new dietary supplement where α-lipoic acid, Boswellia Serrata, methylsulfonylmethane and bromelain are combined in a single capsule. The aim of this prospective study was to determine the efficacy and safety of OPERA ® supplementation in a series of patients affected by CIPN. We selected 25 subjects with CIPN evolving during or after chemotherapy with potentially neurotoxic agents. Patients were enrolled at the first clinical manifestation of neuropathy. CIPN was assessed at the enrollment visit and subsequently repeated every 3 weeks until 12 weeks. Primary endpoint was the evaluation of changes of measured scores after 12 weeks of therapy compared to baseline evaluation. Secondary endpoints were the evaluation of neuropathy reduction at 12 weeks after beginning of therapy with OPERA ® . Analysis of VAS data showed reduction in pain perceived by patients. According to NCI-CTC sensor and motor score, mISS scale and TNSc scale, both pain and both sensor and motor neuropathic impairment decreased after 12 weeks of treatments. Treatment with OPERA supplement was well tolerated; no increase in the toxicity profile of any of the therapeutic regimen that the patients were undergoing was reported. OPERA ® was able to improve CIPN symptoms in a prospective series of patients treated with neurotoxic chemotherapy, with no significant toxicity or interaction. Prospective RCT in a selected patients' population is warranted to confirm its promising activity.

SWIFT: Prospective 48-Week Study to Evaluate Efficacy and Safety of Switching to Emtricitabine/Tenofovir From Lamivudine/Abacavir in Virologically Suppressed HIV-1 Infected Patients on a Boosted Protease Inhibitor Containing Antiretroviral Regimen

PubMed Central

Campo, R.; DeJesus, E.; Bredeek, U. F.; Henry, K.; Khanlou, H.; Logue, K.; Brinson, C.; Benson, P.; Dau, L.; Wang, H.; White, K.; Flaherty, J.; Fralich, T.; Guyer, B.; Piontkowsky, D.

2013-01-01

Background. In the United States, emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is a preferred nucleoside reverse transcriptase inhibitor (NRTI) backbone with lamivudine/abacavir (3TC/ABC) as a commonly used alternative. For patients infected with human immunodeficiency virus (HIV-1) virologically suppressed on a boosted protease inhibitor (PI) + 3TC/ABC regimen, the merits of switching to FTC/TDF as the NRTI backbone are unknown. Methods. SWIFT was a prospective, randomized, open-label 48-week study to evaluate efficacy and safety of switching to FTC/TDF. Subjects receiving 3TC/ABC + PI + ritonavir (RTV) with HIV-1 RNA < 200 c/mL ≥3 months were randomized to continue 3TC/ABC or switch to FTC/TDF. The primary endpoint was time to loss of virologic response (TLOVR) with noninferiority measured by delta of 12%. Virologic failure (VF) was defined as confirmed rebound or the last HIV-1 RNA measurement on study drug ≥200 c/mL. Results. In total, 311 subjects were treated in this study (155 to PI + RTV + FTC/TDF, 156 to PI + RTV + 3TC/ABC). Baseline characteristics were similar between the arms: 85% male, 28% black, median age, 46 years; and median CD4 532 cells/mm3. By TLOVR through week 48, switching to FTC/TDF was noninferior compared to continued 3TC/ABC (86.4% vs 83.3%, treatment difference 3.0% (95% confidence interval, −5.1% to 11.2%). Fewer subjects on FTC/TDF experienced VF (3 vs 11; P = .034). FTC/TDF showed greater declines in fasting low-density lipoproteins (LDL), total cholesterol (TC), and triglycerides (TG) with significant declines in LDL and TC beginning at week 12 with no TC/HDL ratio change. Switching to FTC/TDF showed improved NCEP thresholds for TC and TG and improved 10-year Framingham TC calculated scores. Decreased epidermal growth factor receptor (eGFR) was observed in both arms with a larger decrease in the FTC/TDF arm. Conclusions. Switching to FTC/TDF from 3TC/ABC maintained virologic suppression, had fewer VFs, improved

The Evaluation of a Sexual Assault Self-Defense and Risk-Reduction Program for College Women: A Prospective Study

ERIC Educational Resources Information Center

Gidycz, Christine A.; Rich, Cindy L.; Orchowski, Lindsay; King, Carrie; Miller, Audrey K.

2006-01-01

The present study evaluated the efficacy of a sexual assault risk-reduction program that included a physical self-defense component for college women ("N"=500). Program group women significantly increased their protective behaviors over the 6-month follow-up period compared to the waiting-list control group. However, there were no significant…

Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial.

PubMed

Kim, Ho-Joong; Ahn, Hyo Sae; Nam, Yunjin; Chang, Bong-Soon; Lee, Choon-Ki; Yeom, Jin S

2017-11-01

To compare the efficacy of a transdermal buprenorphine patch (5, 10, 15, and 20 μg/h) with that of oral tramadol (150, 200, 250, and 300 mg) for postoperative pain control after single level spinal fusion surgery. The present study (ClinicalTrials.gov, number NCT02416804) was a prospective, randomized controlled non-inferiority trial designed to determine the efficacy of buprenorphine TDS for alleviating postoperative pain following patient controlled analgesia (PCA) in persons underwent a single level posterior lumbar interbody fusion surgery through 1:1 allocation. The primary outcome was the Visual Analog Pain Scale (VAS) score for postoperative back pain at 7 days after surgery. The non-inferior margin of the VAS was set at δ = 1.5 points. The VAS score (primary outcome) for postoperative back pain at 7 days after surgery in the Buprenorphine group was not inferior compared to the Tramadol group. The overall changes in VAS scores for postoperative pain during follow-up assessments over a 2-week period did not differ between both groups. However, the VAS scores for postoperative pain significantly improved with time after surgery in both groups. The patterns of changes in the VAS scores for postoperative pain during the follow-up period were not significantly different between the both groups. The efficacy of buprenorphine TDS was not inferior to that of oral tramadol medication for alleviating postoperative pain in the subacute period from 72 h after surgery, following PCA administration. In addition, adverse events were similar between both groups.

The efficacy of nonsurgical interventions for pediatric flexible flat foot: a critical review.

PubMed

Jane MacKenzie, Angela; Rome, Keith; Evans, Angela Margaret

2012-12-01

The pediatric flat foot frequently presents as a common parental concern in the health care setting. Foot orthoses are often used, yet benefits are uncertain and disputed, having been variably investigated. A recent Cochrane review cites limited evidence for nonsurgical interventions. This critical and structured review evaluates the effect of pediatric foot orthoses from assessment of the current literature. A systematic search of the following electronic databases: Medline, CINAHL, AMED, and SPORTDiscus, using an array of search terms. A further search was also performed on relevant reference listings. Inclusion criteria were peer-reviewed journal articles, publication date from 1970 onwards, in the English language. Exclusion criteria were surgery interventions, adult subjects, rigid flat foot, articles based on opinion. A structured Quality Index was used to evaluate the research quality of articles. Three reviewers independently assessed the studies with disputes resolved by majority consensus. Studies were then grouped according to the outcome measures used. Thirteen articles, from an initial 429, met the criteria for quality evaluation. The mean Quality Index score was 35% (range: 13% to 81%), indicative of generally poor and varying methodological quality. The low quality of the studies negates definitive conclusions. Only 3/13 quality evaluations scored > 50%; hence, evidence for efficacy of nonsurgical interventions for flexible pediatric flat feet is very limited. Future research needs validated foot type assessment, applicable outcome measures for the intervention, the use of control groups, allowance for independent effects of footwear, age range comparisons, larger samples, and prospective, longer follow-up. There is very limited evidence for the efficacy of nonsurgical interventions for children with flexible flat feet. Clinicians need to consider the lack of good-quality evidence in their decision-making for the management of pediatric flat foot.

Making hard choices easier: a prospective, multicentre study to assess the efficacy of a fertility-related decision aid in young women with early-stage breast cancer

PubMed Central

Peate, M; Meiser, B; Cheah, B C; Saunders, C; Butow, P; Thewes, B; Hart, R; Phillips, K-A; Hickey, M; Friedlander, M

2012-01-01

Background: Fertility is a priority for many young women with breast cancer. Women need to be informed about interventions to retain fertility before chemotherapy so as to make good quality decisions. This study aimed to prospectively evaluate the efficacy of a fertility-related decision aid (DA). Methods: A total of 120 newly diagnosed early-stage breast cancer patients from 19 Australian oncology clinics, aged 18–40 years and desired future fertility, were assessed on decisional conflict, knowledge, decision regret, and satisfaction about fertility-related treatment decisions. These were measured at baseline, 1 and 12 months, and were examined using linear mixed effects models. Results: Compared with usual care, women who received the DA had reduced decisional conflict (β=−1.51; 95%CI: −2.54 to 0.48; P=0.004) and improved knowledge (β=0.09; 95%CI: 0.01–0.16; P=0.02), after adjusting for education, desire for children and baseline uncertainty. The DA was associated with reduced decisional regret at 1 year (β=−3.73; 95%CI: −7.12 to −0.35; P=0.031), after adjusting for education. Women who received the DA were more satisfied with the information received on the impact of cancer treatment on fertility (P<0.001), fertility options (P=0.005), and rated it more helpful (P=0.002), than those who received standard care. Conclusion: These findings support widespread use of this DA shortly after diagnosis (before chemotherapy) among younger breast cancer patients who have not completed their families. PMID:22415294

[Evaluation of the virus-elimination efficacy of nanofiltration (Viresolve NFP) for the parvovirus B19 and hepatitis A virus].

PubMed

Oh, Deok Ja; Lee, Yoo La; Kang, Jae Won; Kwon, So Yong; Cho, Nam Sun; Kim, In Seop

2010-02-01

The safety of plasma derivatives has been reinforced since 1980s by variable pathogen inactivation or elimination techniques. Nucleic acid amplification test (NAT) for the source plasma has also been implemented worldwide. Recently nanofiltration has been used in some country for ensuring safety of plasma derivatives to eliminate non-enveloped viruses such as parvovirus B19 (B19V) and hepatitis A virus (HAV). We evaluated the efficacy of nanofiltration for the elimination of B19V and HAV. To verify the efficacy of nanofiltration, we adopted a 20 nm Viresolve NFP (Millipore, USA) in the scaling down (1:1,370) model of the antithrombin III production. As virus stock solutions, we used B19V reactive plasma and porcine parvovirus (PPV) and HAV obtained from cell culture. And 50% tissue culture infectious dose was consumed as infectious dose. The methods used to evaluate the virus-elimination efficacy were reverse-transcriptase polymerase chain reaction for B19V and the cytopathic effect calculation after filtration for PPV and HAV. B19V was not detected by RT-PCR in the filtered antithrombin III solutions with initial viral load of 6.42 x 10(5) IU/mL and 1.42 x 10(5) IU/mL before filtration. The virus-elimination efficacy of nanofiltration for PPV and HAV were > or = (3.32) and > or = (3.31), respectively. Nanofiltration would be an effective method for the elimination of B19V and HAV. It may be used as a substitute for NAT screening of these viruses in source plasma to ensure safety of plasma derivatives in Korea.

A Clinical Evaluation of Efficacy and Safety of Hyaluronan Sponge with Vitamin C Versus Placebo for Scar Reduction

PubMed Central

Mahedia, Monali; Shah, Nilay

2016-01-01

Background: Scar formation after injury or surgery is a major clinical problem. Individually, hyaluronan, or hyaluronic acid (HA), and vitamin C have been shown to reduce scarring by means of different mechanisms. The authors evaluated the efficacy and safety of an HA sponge system containing an active derivative of vitamin C to determine whether the use of this product promotes healing and reduces inflammation and scarring after surgery. Methods: This double-blind, randomized, prospective study was approved by the local institutional review board. Participants who had unilateral or bilateral surgical scars more than 1 month but less than 18 months old were enrolled. Surgical scars were randomly assigned to receive placebo or HA sponge with vitamin C. Three blinded evaluators reviewed photographs of the incision lines and assessed the scars using a visual analog scale. A patient satisfaction survey was also administered. Participants were followed up at 4 weeks, 12 weeks, and 1 year. Results: Twenty-three patients were enrolled in the study. Six patients dropped out of the study, for a total of 17 patients included in final analysis. Mean (range) age of patient was 43.5 (25–67) years. Mean (range) body mass index was 27.4 (18–36.9) kg/m2. The mean visual analog scale score for scars receiving HA sponge with vitamin C was slightly lower than the scars receiving placebo, but the difference was not statistically significant (t test; P = 0.9). The HA sponge with vitamin C was found to have significant positive findings on a patient satisfaction survey. Conclusions: The HA sponge system with vitamin C is safe to use in any scars older than 4 weeks. It has high patient satisfaction in achieving a better scar after surgery. The micro-roller used to apply the product was easy to use to potentially increase the spread of the medication in older scars. PMID:27536471

Balance self-efficacy in older adults following inpatient rehabilitation.

PubMed

Kuys, Suzanne S; Donovan, Jacquelin; Mattin, Sarah; Low Choy, Nancy L

2015-06-01

Older adults discharging from inpatient rehabilitation were investigated to determine change in self-efficacy at 1 month after discharge, the relationship with discharge balance performance and physical function, and the influence of diagnosis. A prospective cohort of 101 adults older than 50 years of age, 43% men, average age 75.84 (SD 9.8) years, were recruited at discharge from inpatient rehabilitation. Balance self-efficacy was assessed using Activities-specific Balance Confidence (ABC) scale at discharge and 1 month following discharge. Balance and physical function were measured at discharge using the Functional Independence Measure, Balance Outcome Measure for Elder Rehabilitation, Modified Elderly Mobility Scale and gait speed. At discharge, balance self-efficacy was moderate (ABC score 62, SD 23) and did not change at follow-up. When grouped by discharge self-efficacy (ABC scores: low<50; moderate 51-80; high>80), significant between-group differences were found for balance (P=0.005) and physical function (P=0.035). At the 1-month follow-up, those with low discharge balance self-efficacy showed improvement (mean-change ABC score 12, 95% confidence interval 2-22) and those with high discharge balance self-efficacy had lower scores (mean-change ABC score 18, 95% confidence interval -8 to -28). Differences in ABC change scores were also found between diagnostic groups (F=3.740, P=0.03), with the orthopaedic group improving (ABC mean change=8) and the general frailty group showing a decrease in confidence (ABC mean change=10). The differences in balance self-efficacy change at 1 month following discharge were related to self-efficacy level at discharge and clinical group requiring rehabilitation. Clinicians need to be aware of these changes as patients are prepared for discharge.

Human Antibody Responses to the Anopheles Salivary gSG6-P1 Peptide: A Novel Tool for Evaluating the Efficacy of ITNs in Malaria Vector Control

PubMed Central

Drame, Papa Makhtar; Poinsignon, Anne; Besnard, Patrick; Cornelie, Sylvie; Le Mire, Jacques; Toto, Jean-Claude; Foumane, Vincent; Dos-Santos, Maria Adelaide; Sembène, Mbacké; Fortes, Filomeno; Simondon, Francois; Carnevale, Pierre; Remoue, Franck

2010-01-01

To optimize malaria control, WHO has prioritised the need for new indicators to evaluate the efficacy of malaria vector control strategies. The gSG6-P1 peptide from gSG6 protein of Anopheles gambiae salivary glands was previously designed as a specific salivary sequence of malaria vector species. It was shown that the quantification of human antibody (Ab) responses to Anopheles salivary proteins in general and especially to the gSG6-P1 peptide was a pertinent biomarker of human exposure to Anopheles. The present objective was to validate this indicator in the evaluation of the efficacy of Insecticide Treated Nets (ITNs). A longitudinal evaluation, including parasitological, entomological and immunological assessments, was conducted on children and adults from a malaria-endemic area before and after the introduction of ITNs. Significant decrease of anti-gSG6-P1 IgG response was observed just after the efficient ITNs use. Interestingly, specific IgG Ab level was especially pertinent to evaluate a short-time period of ITNs efficacy and at individual level. However, specific IgG rose back up within four months as correct ITN use waned. IgG responses to one salivary peptide could constitute a reliable biomarker for the evaluation of ITN efficacy, at short- and long-term use, and provide a valuable tool in malaria vector control based on a real measurement of human-vector contact. PMID:21179476

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

Evaluating the prospects for sustainable energy development in a sample of Chinese villages.

PubMed

Mortimer, Nigel D; Grant, John F

2008-04-01

This paper describes the methods used to evaluate the potential for achieving sustainable energy development in six Chinese villages included in the Sustainable Users' Concepts for China Engaging Scientific Scenarios (SUCCESS) Project by examining energy efficiency potential and local renewable energy prospects. The approaches needed to obtain and analyse information on possible energy efficiency measures and renewable energy resources are summarised. Results are presented in terms of cumulative net savings in primary energy consumption, as an indicator of energy resource depletion, and associated carbon dioxide emissions, as an indicator of global climate change. Options for sustainable energy development are ranked in order of likely implementation and practical actions which could be considered in each village are identified.

Evaluating the impact of seismic prospecting on artisanal shrimp fisheries

NASA Astrophysics Data System (ADS)

Andriguetto-Filho, José M.; Ostrensky, Antonio; Pie, Marcio R.; Silva, Ubiratã A.; Boeger, Walter A.

2005-09-01

The constant need to discover new hydrocarbon deposits is causing the use of air-guns to become a very widespread method of seismic prospecting. However, there is still disagreement regarding their impact on the marine environment. This uncertainty is particularly severe in the case of shellfish, which account for a substantial share of commercial fisheries and seafood trade in many parts of the world. In this paper we report on the first study to explicitly assess the impact of seismic prospecting on shrimp resources. We measured bottom trawl yields of a nonselective commercial shrimp fishery comprising the Southern white shrimp, Litopenaeus schmitti, the Southern brown shrimp, Farfantepenaeus subtilis, and the Atlantic Seabob, Xyphopenaeus kroyeri (Decapoda: Penaeidae), before and after the use of an array of four synchronized air-guns, each with 635 in 3 of total capacity, 2.000 psi, and peak pressure of 196 dB (re 1 μPa at 1 m). Our results did not detect significant deleterious impact of seismic prospecting on the studied species, suggesting that shrimp stocks are resilient to the disturbance by air-guns under our experimental conditions.

[Application and prospect of scale measurement and appraisal in the assessment in TCM therapeutic efficacy evaluation].

PubMed

Liu, Feng-Bin

2007-12-01

The assessing contents of the health related quality of life (HRQOL) and the patient reported outcomes (PRO) are identical with the inquiry of traditional Chinese medicine (TCM), which are uniformly soft indicators which could be evaluated with the scales for instruments. The assessing method for the soft indicator in the HRQOL and PRO was gradually accepted by TCM practitioners and applied in evaluating the curative effect of TCM. The applying scale in the assessment of curative effect of TCM and the developing scale with the TCM features just started in the TCM field. There was much inadequacy in the scale study, such as no penetrating understanding of the theory and connotation of the scale in the HRQOL and PRO, on scale system for TCM, no direction in selecting scale, not standardizing in the design of the study with scale in the practice. So, it is necessary that the international guideline of developing scale applied for worldwide should be carried out in the study for developing scale. Meanwhile, it must also be under the guidance of TCM theory in the whole course. It will promote the normalization development of applying scale in the assessment of curative effect in the TCM practice.

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…

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

A Study on Prospective Teachers' Self-Efficacy Beliefs Regarding the Implementation of Constructivist Approach (A Case of Konya)

ERIC Educational Resources Information Center

Ektem, Isil Sönmez

2016-01-01

The purpose of this study was to reveal prospective teachers' perceptions and views about the implementation of the constructivist approach. The study was conducted on 528 prospective teachers in their 4th year at Necmettin Erbakan University Ahmet Kelesoglu Education Faculty and Selcuk University Faculty of Science and Faculty of Letters in the…

Safety and efficacy of an intensive insulin protocol in a burn-trauma intensive care unit.

PubMed

Cochran, Amalia; Davis, Lynn; Morris, Stephen E; Saffle, Jeffrey R

2008-01-01

Aggressive glycemic management in critically ill patients with acute burn injury or life-threatening soft-tissue infections has not been thoroughly evaluated. An intensive insulin protocol with target glucose values of less than 120 mg/dl was implemented in October 2005 in our regional Burn-Trauma intensive care unit. We reviewed our initial experience with this protocol to evaluate the safety and efficacy of aggressive glycemic control in these patient groups. Patients were placed on the intensive insulin protocol based upon the need for glycemic management during their hospitalization for burn or soft-tissue disease. Patient information prospectively collected while on protocol included all measured blood glucose values, total daily insulin use, and incidence of hypoglycemic episodes, defined as serum glucose <60 mg/dl. Thirty patients (17 burns, 13 soft-tissue infections) were placed on the intensive insulin protocol during the first 16 months of use. The mean daily blood glucose level for burn patients was 115.9 mg/dl and for soft-tissue disease patients was 119.5 mg/dl. There was a 5% incidence of hypoglycemic episodes per protocol day. All hypoglycemic episodes were treated by holding the insulin infusion, and no episode had known adverse effects. Hyperglycemia in critically ill patients with burns and extensive soft-tissue disease can be effectively managed with an insulin protocol that targets blood glucose values of less than 120 mg/dl with minimal incidence of hypoglycemia. A multicenter prospective randomized trial would provide the ideal forum for evaluating clinical outcome benefits of using an intensive insulin protocol.

Evaluation of efficacy in a pancreas and pancreas-kidney pretransplantation orientation group.

PubMed

Guimaro, M Simon; Yonezawa, E Aparecida Yamada; Lacerda, S Silva; Karam, C Hegedus; de Sá, J Roberto; Miranda, M Perosa de; Andreoli, P Bruno de Araújo

2007-10-01

There is evidence of benefits from psycho-educational groups in the compliance of patients undergoing complex procedures. Psycho-educational groups provide information, elucidate doubts and realities, fade out fantasies, and help lessen patients' anxieties, thus minimizing the chances of complications or irregular behavior. The objective of this study was to evaluate the efficacy of an interdisciplinary orientation group for pretransplantation preparation for pancreas/pancreas-kidney grafting. All patients and their accompanying persons who attended information groups from February to August 2005 completed a questionnaire with 15 relevant items about the transplantation process. The efficiency of the orientation group was evaluated according to the percentage of correct answers before and after attending the group. Twenty-seven subjects were evaluated demonstrating an increased number of right answers in 78% of the evaluated items after group attendance. An important improvement was observed in the following items: function of serum sent to the Central Laboratory; serum replacement period; kind of renal donor; blood transfusion; using medicaments; and how often should the patient return for an appointment with the surgeon within the first month. Further items such as surgery risks, using immunosuppressive drugs, and forgetting the medication showed 100% correct answers before and after attending the group. Results suggest that the pretransplantation orientation group is an efficient way to provide information. Applying a knowledge verification questionnaire before and after the group helps to understand the difficulties of participants, thereby guiding the team and elucidating questions that need more consideration.

Conceptual dissonance: evaluating the efficacy of natural language processing techniques for validating translational knowledge constructs.

PubMed

Payne, Philip R O; Kwok, Alan; Dhaval, Rakesh; Borlawsky, Tara B

2009-03-01

The conduct of large-scale translational studies presents significant challenges related to the storage, management and analysis of integrative data sets. Ideally, the application of methodologies such as conceptual knowledge discovery in databases (CKDD) provides a means for moving beyond intuitive hypothesis discovery and testing in such data sets, and towards the high-throughput generation and evaluation of knowledge-anchored relationships between complex bio-molecular and phenotypic variables. However, the induction of such high-throughput hypotheses is non-trivial, and requires correspondingly high-throughput validation methodologies. In this manuscript, we describe an evaluation of the efficacy of a natural language processing-based approach to validating such hypotheses. As part of this evaluation, we will examine a phenomenon that we have labeled as "Conceptual Dissonance" in which conceptual knowledge derived from two or more sources of comparable scope and granularity cannot be readily integrated or compared using conventional methods and automated tools.

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)

Open-Label, Prospective Trial of Olanzapine in Adolescents with Subaverage Intelligence and Disruptive Behavioral Disorders

ERIC Educational Resources Information Center

Handen, Benjamin L.; Hardan, Antonio Y.

2006-01-01

Objective: Olanzapine, an atypical antipsychotic, has been shown to be efficacious for treatment of psychotic and mood disorders in adults. This prospective, open-label study was conducted to examine the safety and usefulness of olanzapine in treating disruptive behavior disorders in adolescents with subaverage intelligence. Method: Sixteen…

A Prospective Evaluation of Early Detection Biomarkers for Ovarian Cancer in the European EPIC Cohort.

PubMed

Terry, Kathryn L; Schock, Helena; Fortner, Renée T; Hüsing, Anika; Fichorova, Raina N; Yamamoto, Hidemi S; Vitonis, Allison F; Johnson, Theron; Overvad, Kim; Tjønneland, Anne; Boutron-Ruault, Marie-Christine; Mesrine, Sylvie; Severi, Gianluca; Dossus, Laure; Rinaldi, Sabina; Boeing, Heiner; Benetou, Vassiliki; Lagiou, Pagona; Trichopoulou, Antonia; Krogh, Vittorio; Kuhn, Elisabetta; Panico, Salvatore; Bueno-de-Mesquita, H Bas; Onland-Moret, N Charlotte; Peeters, Petra H; Gram, Inger Torhild; Weiderpass, Elisabete; Duell, Eric J; Sanchez, Maria-Jose; Ardanaz, Eva; Etxezarreta, Nerea; Navarro, Carmen; Idahl, Annika; Lundin, Eva; Jirström, Karin; Manjer, Jonas; Wareham, Nicholas J; Khaw, Kay-Tee; Byrne, Karl Smith; Travis, Ruth C; Gunter, Marc J; Merritt, Melissa A; Riboli, Elio; Cramer, Daniel W; Kaaks, Rudolf

2016-09-15

About 60% of ovarian cancers are diagnosed at late stage, when 5-year survival is less than 30% in contrast to 90% for local disease. This has prompted search for early detection biomarkers. For initial testing, specimens taken months or years before ovarian cancer diagnosis are the best source of information to evaluate early detection biomarkers. Here we evaluate the most promising ovarian cancer screening biomarkers in prospectively collected samples from the European Prospective Investigation into Cancer and Nutrition study. We measured CA125, HE4, CA72.4, and CA15.3 in 810 invasive epithelial ovarian cancer cases and 1,939 controls. We calculated the sensitivity at 95% and 98% specificity as well as area under the receiver operator curve (C-statistic) for each marker individually and in combination. In addition, we evaluated marker performance by stage at diagnosis and time between blood draw and diagnosis. We observed the best discrimination between cases and controls within 6 months of diagnosis for CA125 (C-statistic = 0.92), then HE4 (0.84), CA72.4 (0.77), and CA15.3 (0.73). Marker performance declined with longer time between blood draw and diagnosis and for earlier staged disease. However, assessment of discriminatory ability at early stage was limited by small numbers. Combinations of markers performed modestly, but significantly better than any single marker. CA125 remains the single best marker for the early detection of invasive epithelial ovarian cancer, but can be slightly improved by combining with other markers. Identifying novel markers for ovarian cancer will require studies including larger numbers of early-stage cases. Clin Cancer Res; 22(18); 4664-75. ©2016 AACRSee related commentary by Skates, p. 4542. ©2016 American Association for Cancer Research.

A randomized, placebo-controlled, double-blind, prospective trial to evaluate the effect of vildagliptin in new-onset diabetes mellitus after kidney transplantation.

PubMed

Haidinger, Michael; Werzowa, Johannes; Voigt, Hans-Christian; Pleiner, Johannes; Stemer, Gunar; Hecking, Manfred; Döller, Dominik; Hörl, Walter H; Weichhart, Thomas; Säemann, Marcus D

2010-10-06

New-onset diabetes mellitus after transplantation (NODAT), a frequent and serious complication after transplantation, is associated with decreased graft and patient survival. Currently, it is diagnosed and treated primarily according to existing guidelines for type II diabetes. To date, only a few trials have studied antidiabetic drugs in patients with NODAT. Vildagliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor that improves pancreatic islet function by enhancing both α- and β-cell responsiveness to increased blood glucose. Experimental data show potential protective effects of DPP-4 inhibitors on islet function after exogenous stress stimuli including immunosuppressants. Therefore, the therapy of NODAT with this class of compounds seems attractive. At present, vildagliptin is used to treat type II diabetes as monotherapy or in combination with other antidiabetic drugs, since that it efficiently decreases glycated hemoglobin (HbA1c) values. Additionally, vildagliptin has been shown to be safe in patients with moderately impaired kidney function. This study will evaluate the safety and efficacy of vildagliptin monotherapy in renal transplant recipients with recently diagnosed NODAT. This study is a randomized, placebo-controlled, double-blind, prospective phase II trial. Using the results of routinely performed oral glucose tolerance tests (OGTT) in stable renal transplant patients at our center, we will recruit patients without a history of diabetes and a 2 h glucose value surpassing 200 mg/dl (11.1 mmol/l). They are randomized to receive either 50 mg vildagliptin or placebo once daily. A total of 32 patients with newly diagnosed NODAT will be included. The primary endpoint is the difference in the 2 h glucose value between baseline and the repeated OGTT performed 3 months after treatment start, compared between the vildagliptin- and the placebo-group. Secondary endpoints include changes in HbA1c and fasting plasma glucose (FPG). The safety of

An evaluation of the efficacy of a triple P-positive parenting program podcast series.

PubMed

Morawska, Alina; Tometzki, Helen; Sanders, Matthew R

2014-01-01

Parenting programs based on cognitive-behavioral and social learning principles are effective in changing child behavior problems and parenting styles. However, such programs typically have limited population reach. The current study aimed to evaluate the efficacy of a brief radio series that provided parenting advice based on the Triple P-Positive Parenting Program. One hundred thirty-nine parents of children aged 2 to 10 years who had concerns about their child's behavioral and/or emotional adjustment were recruited, randomly assigned to either an intervention or waitlist control group, and completed online self-report measures. Parents in the intervention group were given access to seven Triple P podcasts online over a period of 2 weeks. Parents in the intervention group improved significantly more than parents in the control group, from pre- to postintervention, on measures of child behavioral problems and parenting style, self-efficacy, and confidence. These short-term intervention effects were maintained at the 6-month follow-up. These results suggest that brief radio and online parenting programs can be effective and have the potential to reach a large proportion of parents experiencing child behavior problems. Limitations, clinical significance, and future research suggestions are discussed.

Evaluating Corrective Feedback Self-Efficacy Changes among Counselor Educators and Site Supervisors

ERIC Educational Resources Information Center

Motley, Veronica; Reese, Mary Kate; Campos, Peter

2014-01-01

Analysis of pretest-posttest scores on the Corrective Feedback Self-Efficacy Instrument (Page & Hulse-Killacky, [Page, B. J., 1999]) following a supervision workshop indicated a significant positive relationship between workshop training and supervisors' feedback self-efficacy in giving corrective feedback. Furthermore, the association…

A Prospective, Blinded, Multicenter Clinical Trial to Compare the Efficacy, Accuracy, and Safety of In-Office Diagnostic Arthroscopy With Magnetic Resonance Imaging and Surgical Diagnostic Arthroscopy.

PubMed

Gill, Thomas J; Safran, Marc; Mandelbaum, Bert; Huber, Bryan; Gambardella, Ralph; Xerogeanes, John

2018-05-24

The purpose of this study was to compare the efficacy, accuracy, and safety of in-office diagnostic arthroscopy with magnetic resonance imaging (MRI) and surgical diagnostic arthroscopy. A prospective, blinded, multicenter, clinical trial was performed on 110 patients, ages 18 to 75 years, who presented with knee pain. The study period was April 2012 to April 2013. Each patient underwent a physical examination, an MRI, in-office diagnostic imaging, and a diagnostic arthroscopic examination in the operating room. The attending physician completed clinical report forms comparing the in-office arthroscopic examination and surgical diagnostic arthroscopy findings on each patient. Two blinded experts, unaffiliated with the clinical care of the study's subjects, reviewed the in-office arthroscopic images and MRI images using the surgical diagnostic arthroscopy images as the "control" group comparison. Patients were consecutive, and no patients were excluded from the study. In this study, the accuracy, sensitivity, and specificity of in-office arthroscopy was equivalent to surgical diagnostic arthroscopy and more accurate than MRI. When comparing in-office arthroscopy with surgical diagnostic arthroscopy, all kappa statistics were between 0.766 and 0.902. For MRI compared with surgical diagnostic arthroscopy, kappa values ranged from a low of 0.130 (considered "slight" agreement) to a high of 0.535 (considered "moderate" agreement). The comparison of MRI to in-office arthroscopy showed very similar results as the comparison of MRI with surgical diagnostic arthroscopy, ranging from a low kappa of 0.112 (slight agreement) to a high of 0.546 (moderate agreement). There were no patient-related or device-related complications related to the use of in-office arthroscopy. Needle-based diagnostic imaging that can be used in the office setting is statistically equivalent to surgical diagnostic arthroscopy with regard to the diagnosis of intra-articular, nonligamentous knee joint

Prospective Patient-Related Outcome Evaluation of Secondary Cleft Rhinoplasty Using a Validated Questionnaire.

PubMed

Sawyer, Adam R; Robinson, Stephen; Cadier, Michael

2017-07-01

To evaluate patient satisfaction and quality of life following secondary cleft rhinoplasty. Prospective consecutive patient, single unit, single surgeon study. Spires Cleft Centre, Salisbury, Wilshire, United Kingdom, and private practice. 56 (27 secondary cleft rhinoplasty) patients completed evaluation forms preoperatively and 3 to 6 months postoperatively. Subjective assessment was performed using a validated Rhinoplasty Outcomes Evaluation (ROE) questionnaire. This instrument comprises six questions that capture three quality-of-life domains: physical, mental/emotional, and social. Rhinoplasty outcomes evaluation scores were calculated (range = 0 to 100) to indication satisfaction with rhinoplasty outcomes. Average age was 28 years (range = 18 to 59 years). There was a significant subjective improvement in the total ROE evaluation scores from 28 ± 10 to 80 ± 11 (P < .01) in secondary cleft rhinoplasty. Similar results were achieved in noncleft rhinoplasty 34 ± 9 to 84 ± 9 (P < .01). Specific scores for nasal aesthetic appearance improved from 0.3 ± 0.2 to 3.2 ± 0.3 (P < .01) in secondary cleft rhinoplasty. No significant change was seen in breathing capacity in secondary cleft rhinoplasty (from 2.7 ± 0.3 to 3.2 ± 0.2; P = .29). All patients said they would undergo the procedure again. Our results demonstrate high patient satisfaction after cleft rhinoplasty with particular regard to cosmetic appearance. These results are similar to those for noncleft rhinoplasty. We would recommend the use of this simple and quick validated outcome tool with all rhinoplasty patients.

Development and Evaluation of Two Abbreviated Questionnaires for Mentoring and Research Self-Efficacy.

PubMed

Jeffe, Donna B; Rice, Treva K; Boyington, Josephine E A; Rao, Dabeeru C; Jean-Louis, Girardin; Dávila-Román, Victor G; Taylor, Anne L; Pace, Betty S; Boutjdir, Mohamed

2017-01-01

To reduce respondent burden for future evaluations of the National Heart, Lung, and Blood Institute-supported Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE), a mentored-research education program, we sought to shorten the 33-item Ragins and McFarlin Mentor Role Instrument (RMMRI), measuring mentor-role appraisals, and the 69-item Clinical Research Appraisal Inventory (CRAI), measuring research self-efficacy. Three nationally recruited, junior-faculty cohorts attended two, annual 2-3 week Summer Institutes (SI-1/SI-2: 2011/2012, 2012/2013, 2013/2014) at one of six PRIDE sites. Mentees completed the RMMRI two months after mentor assignment and the CRAI at baseline (pre-SI-1) and 6-month (mid-year) and 12-month (post-SI-2) follow-up. Publications data obtained from Scopus in October 2015 were verified with mentees' curriculum vitae. The RMMRI and CRAI were shortened using an iterative process of principal-components analysis. The shortened measures were examined in association with each other (multiple linear regression) and with increase in publications (repeated-measures analysis of covariance). PRIDE enrolled 152 mentees (70% women; 60% Black, 35% Hispanic/Latino). Cronbach's alphas for the new 9-item RMMRI, 19-item CRAI, and four CRAI-19 subscales were excellent. Controlling for baseline self-efficacy and cohort, RMMRI-9 scores were independently, positively associated with post-SI-2 scores on the CRAI-19 and three subscales (writing, study design/data analysis, and collaboration/grant preparation). Controlling for cohort, higher RMMRI-9 and post-SI-2 CRAI-19 scores were each associated with greater increase in publications. The RMMRI-9 and CRAI-19 retained the excellent psychometric properties of the longer measures. Findings support use of the shortened measures in future evaluations of PRIDE.

The safety and efficacy of the "inside-out" trans-obturator TVT in elderly versus younger stress-incontinent women: a prospective study of 353 consecutive patients.

PubMed

Groutz, Asnat; Cohen, Aviad; Gold, Ronen; Pauzner, David; Lessing, Joseph B; Gordon, David

2011-03-01

To analyze the safety and efficacy of the trans-obturator tension-free vaginal tape (TVT-O) in elderly versus younger stress-incontinent women. Ninety-seven consecutive elderly, aged 70 and older, and 256 younger women (mean age 75 and 55 years, respectively) who underwent TVT-O for urodynamically confirmed stress urinary incontinence (SUI) were prospectively enrolled. Concomitant pelvic organ prolapse (POP) repair was performed in 90% of the elderly and 70% of the younger women. The surgical procedures, as well as all pre- and postoperative clinical and urodynamic evaluation, were performed in one university-affiliated medical center. Main outcome measures were operative complications, early and late postoperative morbidity, postoperative urodynamically confirmed SUI (symptomatic, or asymptomatic), persistent, or de novo overactive bladder (OAB) and bladder outlet obstruction (BOO). Mean follow-up of the patients was 30 ± 17 months (range 3-58 months). Early and late postoperative morbidity was similar in both groups, except for significantly more cases of postoperative recurrent UTI's among elderly women (13.7% vs. 6.2%). The incidence of persistent urodynamically confirmed overt SUI was similar in both age groups (5%). However, asymptomatic urodynamic SUI was significantly more common among elderly patients (19% vs. 3.7%, P<0.05). The incidence of persistent OAB was similar in elderly and younger patients (68% and 62%, respectively), while de novo OAB was significantly more common in elderly patients (11.9% vs. 4.7%, P<0.05). TVT-O is safe and efficient for both elderly and younger stress-incontinent women. However, elderly patients are in increased risk for postoperative recurrent UTI's as well as de novo OAB. Copyright © 2010 Wiley-Liss, Inc.

Prospective studies of the efficacy and safety of the picosecond 755, 1,064, and 532 nm lasers for the treatment of infraorbital dark circles.

PubMed

Vanaman Wilson, Monique J; Jones, Isabela T; Bolton, Joanna; Larsen, Lisa; Wu, Douglas C; Goldman, Mitchel P

2018-01-01

Infraorbital dark circles result from a combination of factors. The fractionated picosecond 755 nm alexandrite laser and dual wavelength picosecond Nd:YAG laser have not been examined as a method of addressing infraorbital hyperpigmentation. To determine the efficacy and safety of treatment of infraorbital dark circles using fractionated picosecond 755 nm and dual wavelength picosecond Nd:YAG laser. These trials did not utilize a comparative design; rather, these were separate, prospective, open-label, evaluator-blinded trials utilizing two treatment regimens: (i) 19 adult subjects were treated in a single session with the dual wavelengths of 532 nm and 1,064 nm in consecutive passes using the fractionated lens; (ii) 10 adult subjects were treated using the picosecond 755 nm laser via the fractionated lens in three treatment sessions at 3 week intervals. Subjects in both studies were followed-up for blinded-investigator assessment of infraorbital hyperpigmentation, adverse events, and improvement compared to baseline. The dual wavelength picosecond Nd:YAG laser, blinded-investigator assessment did not demonstrate a significant improvement in infraorbital hyperpigmentation at day 60 (P = 0.16). The picosecond 755 nm alexandrite laser significantly improved infraorbital hyperpigmentation by day 42, with improvement maintained through day 132 (P = 0.07 and 0.00001, respectively). Adverse events were mild and temporary. A single treatment with the fractionated picosecond 1,064/532 nm lasers did not produce a significant improvement in infraorbital hyperpigmentation. A series of three treatments with the fractionated picosecond 755 nm laser resulted in significant improvement in hyperpigmentation. Lasers Surg. Med. 50:45-50, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Clinical and electrophysiologic results after intracameral lidocaine 1% anesthesia: a prospective randomized study.

PubMed

Anders, N; Heuermann, T; Rüther, K; Hartmann, C

1999-10-01

To evaluate the efficacy and safety of intracameral lidocaine in cataract surgery compared to peribulbar anesthesia. A prospective, randomized, controlled study. A total of 200 consecutive cataract patients (200 eyes) participated. Eyes were randomly assigned to two groups: one group received 0.15 ml intracameral 1% unpreserved lidocaine combined with topical anesthesia (oxybuprocaine); the other group received 6 ml prilocaine peribulbar before phacoemulsification with sclerocorneal tunnel incision. Duration of surgery was measured; implicit time and amplitudes of the b-waves of the photopic electroretinogram (ERG) potentials (single-flash ERG and the 30-Hz flicker ERG) were recorded; frequencies of intraoperative problems, complications, intraoperative, and postoperative pain were evaluated. After lidocaine anesthesia combined with topical anesthesia, similar complications were found, longer operation time (P < 0.001), and significantly better visual acuity immediately after surgery (P < 0.001). The ERG amplitudes were not significantly reduced after 0.15-ml intracameral lidocaine half an hour after surgery (P > 0.05). Intracameral lidocaine 1% combined with topical anesthesia can be recommended as an alternative procedure to peribulbar anesthesia in cataract surgery with corneoscleral tunnel incision.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. I. Main results of the studies].

PubMed

Jermendy, György

2018-04-01

The effect of antihyperglycaemic (antidiabetic) treatment on the late diabetic complications is one of the most important research areas in clinical diabetology. The relationship between glycaemic control and late micro- and macrovascular complications was highlighted by the results of the DCCT (Diabetes Control and Complications Trial) with type 1 and by the UKPDS (United Kingdom Prospective Diabetes Study) with type 2 diabetic patients. In these studies, observational follow-up investigations were also performed after the close-out of the randomized phase of the trial. In addition to these landmark studies, other randomized, controlled efficacy trials were also performed with observational follow-up investigations resulting in the development of the concept of metabolic memory or metabolic legacy. In this article, the main results of the studies are summarized. Orv Hetil. 2018; 159(15): 575-582.

Laboratory evaluation of the predation efficacy of native Australian fish on Culex annulirostris (Diptera: Culicidae).

PubMed

Hurst, Timothy P; Brown, Michael D; Kay, Brian H

2004-09-01

The introduction and establishment of fish populations can provide long-term, cost-effective mosquito control in habitats such as constructed wetlands and ornamental lakes. The predation efficacy of 7 native Brisbane freshwater fish on 1st and 4th instars of the freshwater arbovirus vector Culex annulirostris was evaluated in a series of 24-h laboratory trials. The trials were conducted in 30-liter plastic carboys at 25+/-1 degrees C under a light:dark cycle of 14:10 h. The predation efficacy of native crimson-spotted rainbowfish Melanotaenia duboulayi (Melanotaeniidae), Australian smelt Retropinna semoni (Retropinnadae), Pacific blue-eye Pseudomugil signifer (Atherinidae), fly-specked hardyhead Craterocephalus stercusmuscarum (Atherinidae), firetail gudgeon Hypseleotris galii (Eleotridae), empire gudgeon Hypseleotris compressa (Eleotridae), and estuary perchlet Ambassis marianus (Ambassidae) was compared with the exotic eastern mosquitofish Gambusia holbrooki (Poeciliidae). This environmentally damaging exotic has been disseminated worldwide and has been declared noxious in Queensland. Melanotaenia duboulayi was found to consume the greatest numbers of both 1st and 4th instars of Cx. annulirostris. The predation efficacy of the remaining Australian native species was comparable with that of the exotic G. holbrooki. With the exception of A. marianus, the maximum predation rates of these native species were not statistically different whether tested individually or in a school of 6. Based on these data, M. duboulayi, H. compressa, and A. marianus warrant further investigation as biological control agents in pilot field trials.

Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases.

PubMed

Bagla, Sandeep; Sayed, Dawood; Smirniotopoulos, John; Brower, Jayson; Neal Rutledge, J; Dick, Bradley; Carlisle, James; Lekht, Ilya; Georgy, Bassem

2016-09-01

Radiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM. Fifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval. Twenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported. RFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

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

Prospective evaluation of luteal phase length and natural fertility.

PubMed

Crawford, Natalie M; Pritchard, David A; Herring, Amy H; Steiner, Anne Z

2017-03-01

To evaluate the impact of a short luteal phase on fecundity. Prospective time-to-pregnancy cohort study. Not applicable. Women trying to conceive, ages 30-44 years, without known infertility. Daily diaries, ovulation prediction testing, standardized pregnancy testing. Subsequent cycle fecundity. Included in the analysis were 1,635 cycles from 284 women. A short luteal phase (≤11 days including the day of ovulation) occurred in 18% of observed cycles. Mean luteal phase length was 14 days. Significantly more women with a short luteal phase were smokers. After adjustment for age, women with a short luteal phase had 0.82 times the odds of pregnancy in the subsequent cycle immediately following the short luteal phase compared with women without a short luteal phase. Women with a short luteal length in the first observed cycle had significantly lower fertility after the first 6 months of pregnancy attempt, but at 12 months there was no significant difference in cumulative probability of pregnancy. Although an isolated cycle with a short luteal phase may negatively affect short-term fertility, incidence of infertility at 12 months was not significantly higher among these women. NCT01028365. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.