WorldWideScience

Sample records for evaluation post trial

  1. Aerobic Exercise Training in Post-Polio Syndrome: Process Evaluation of a Randomized Controlled Trial

    NARCIS (Netherlands)

    Voorn, Eric L.; Koopman, Fieke S.; Brehm, Merel A.; Beelen, Anita; de Haan, Arnold; Gerrits, Karin H. L.; Nollet, Frans

    2016-01-01

    To explore reasons for the lack of efficacy of a high intensity aerobic exercise program in post-polio syndrome (PPS) on cardiorespiratory fitness by evaluating adherence to the training program and effects on muscle function. A process evaluation using data from an RCT. Forty-four severely fatigued

  2. Evaluation of plitidepsin in patients with primary myelofibrosis and post polycythemia vera/essential thrombocythemia myelofibrosis: results of preclinical studies and a phase II clinical trial

    International Nuclear Information System (INIS)

    Pardanani, A; Tefferi, A; Guglielmelli, P; Bogani, C; Bartalucci, N; Rodríguez, J; Extremera, S; Pérez, I; Alfaro, V; Vannucchi, A M

    2015-01-01

    Previous data established that plitidepsin, a cyclic depsipeptide, exerted activity in a mouse model of myelofibrosis (MF). New preclinical experiments reported herein found that low nanomolar plitidepsin concentrations potently inhibited the proliferation of JAK2V617F-mutated cell lines and reduced colony formation by CD34+ cells of individuals with MF, at least in part through modulation of p27 levels. Cells of MF patients had significantly reduced p27 content, that were modestly increased upon plitidepsin exposure. On these premise, an exploratory phase II trial evaluated plitidepsin 5 mg/m 2 3-h intravenous infusion administered on days 1 and 15 every 4 weeks (q4wk). Response rate (RR) according to the International Working Group for Myelofibrosis Research and Treatment consensus criteria was 9.1% (95% CI, 0.2–41.3%) in 11 evaluable patients during the first trial stage. The single responder achieved a red cell transfusion independence and stable disease was reported in nine additional patients (81.8%). Eight patients underwent a short-lasting improvement of splenomegaly. In conclusion, plitidepsin 5 mg/m 2 3-h infusion q4wk was well tolerated but had a modest activity in patients with primary, post-polycythaemia vera or post-essential thrombocythaemia MF. Therefore, this trial was prematurely terminated and we concluded that further clinical trials with plitidepsin as single agent in MF are not warranted

  3. Evaluation of the effect of aromatherapy with lavender essential oil on post-tonsillectomy pain in pediatric patients: a randomized controlled trial.

    Science.gov (United States)

    Soltani, Rasool; Soheilipour, Saeed; Hajhashemi, Valiollah; Asghari, Gholamreza; Bagheri, Mahdi; Molavi, Mahdi

    2013-09-01

    To evaluate the effect of aromatherapy with Lavandula angustifolia essential oil on post-tonsillectomy pain in pediatric patients. This was a randomized controlled prospective clinical trial. In this study, 48 post-tonsillectomy patients aged 6-12 years were randomly assigned to two groups (24 patients in each group). After tonsillectomy surgery, all patients received acetaminophen (10-15 mg/kg/dose, PO) every 6h as necessary to relieve pain. The patients of the case group also inhaled lavender essential oil. The frequencies of daily use of acetaminophen and nocturnal awakening due to pain, and pain intensity (evaluated using visual analog scale [VAS]) were recorded for each patient for 3 days after surgery. Finally, the mean values of variables were compared between two groups separately for each post-operative day. The use of lavender essential oil caused statistically significant reduction in daily use of acetaminophen in all three post-operative days but had not significant effects on pain intensity and frequency of nocturnal awakening. Aromatherapy with lavender essential oil decreases the number of required analgesics following tonsillectomy in pediatric patients. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  4. Right on Post-trial Access to Investigational Treatment

    Directory of Open Access Journals (Sweden)

    Dmytro Lurye

    2018-03-01

    On this base, the author offered to provide in the legislation of Ukraine requirements to inform in advance subjects about the presence or absence of post-trial access and to evaluate these provisions by ethics committees before and at the end of all trials in order to determine its real need in each individual case. The scope of the right on post-trial access to investigational treatment must be reasonably weighed in order to avoid, on the one hand, becoming an excessive stimulus for the subjects, and, on the other hand, not leading to a situation where on such regulation conducting of clinical trials in the country will no longer be appropriate.

  5. Clinical evaluation of a novel dental implant system as single implants under immediate loading conditions - 4-month post-loading results from a multicentre randomised controlled trial.

    Science.gov (United States)

    Esposito, Marco; Trullenque-Eriksson, Anna; Blasone, Rodolfo; Malaguti, Giuliano; Gaffuri, Cristiano; Caneva, Marco; Minciarelli, Armando; Luongo, Giuseppe

    To evaluate the safety and clinical effectiveness of a novel dental implant system (GENESIS Implant System, Keystone Dental, Massachusetts, USA) using another dental implant system by the same manufacturer as a control (PRIMA Implant System, Keystone Dental). A total of 53 patients requiring at least two single crowns had their sites randomised according to a split-mouth design to receive both implant systems at six centres. If implants could be placed with a torque superior to 40 Ncm they were to be loaded immediately with provisional crowns, otherwise after 3 months of submerged healing. Provisional crowns were replaced by definitive crowns 4 months after initial loading, when the follow-up period for the initial part of this study was completed. Outcome measures were crown/implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, plaque score, marginal bleeding, patients and preference of the clinician. In total 53 PRIMA and 53 GENESIS implants were placed. Three patients dropped out but all of the remaining patients were followed up to 4-months post-loading. No PRIMA implant failed whereas four GENESIS implants failed. Only two complications were reported for PRIMA implants. There were no statistically significant differences for crown/implant failures (difference in proportions = 0.080; P (McNemar test) = 0.125) and complications (difference in proportions = -0.04; P (McNemar test) = 0.500) between the implant systems. There were no differences at 4-months post-loading for plaque (difference = -0.54, 95% CI: -3.01 to 1.93; P (Paired t-test) = 0.660), marginal bleeding (difference = -3.8, 95% CI: -7.63 to 0.019; P (Paired t-test) = 0.051), PES (difference = 0.47, 95% CI: -0.56 to 1.50; P (Paired t-test) = 0.365) and marginal bone level changes (difference in mm = -0.04, 95% CI: -0.33 to 0.26; P (Paired t-test) = 0.795). The majority of the patients (46) had no

  6. From rehabilitation to recovery: protocol for a randomised controlled trial evaluating a goal-based intervention to reduce depression and facilitate participation post-stroke

    Directory of Open Access Journals (Sweden)

    Hill Keith

    2011-06-01

    Full Text Available Abstract Background There is much discourse in healthcare about the importance of client-centred rehabilitation, however in the realm of community-based therapy post-stroke there has been little investigation into the efficacy of goal-directed practice that reflects patients' valued activities. In addition, the effect of active involvement of carers in such a rehabilitation process and their subsequent contribution to functional and emotional recovery post-stroke is unclear. In community based rehabilitation, interventions based on patients' perceived needs may be more likely to alter such outcomes. In this paper, we describe the methodology of a randomised controlled trial of an integrated approach to facilitating patient goal achievement in the first year post-stroke. The effectiveness of this intervention in reducing the severity of post-stroke depression, improving participation status and health-related quality of life is examined. The impact on carers is also examined. Methods/Design Patients (and their primary carers, if available are randomly allocated to an intervention or control arm of the study. The intervention is multimodal and aims to screen for adverse stroke sequelae and address ways to enhance participation in patient-valued activities. Intervention methods include: telephone contacts, written information provision, home visitation, and contact with treating health professionals, with further relevant health service referrals as required. The control involves treatment as usual, as determined by inpatient and community rehabilitation treating teams. Formal blinded assessments are conducted at discharge from inpatient rehabilitation, and at six and twelve months post-stroke. The primary outcome is depression. Secondary outcome measures include participation and activity status, health-related quality of life, and self-efficacy. Discussion The results of this trial will assist with the development of a model for community

  7. Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation.

    Science.gov (United States)

    Desveaux, Laura; Beauchamp, Marla K; Lee, Annemarie; Ivers, Noah; Goldstein, Roger; Brooks, Dina

    2016-05-11

    This manuscript (1) outlines the intervention, (2) describes how its effectiveness is being evaluated in a pragmatic randomized controlled trial, and (3) summarizes the embedded process evaluation aiming to understand key barriers and facilitators for implementation in new environments. Participating centers refer eligible individuals with COPD following discharge from their local PR program. Consenting patients are assigned to a year-long community exercise program or usual care using block randomization and stratifying for supplemental oxygen use. Patients in the intervention arm are asked to attend an exercise session at least twice per week at their local community facility where their progress is supervised by a case manager. Each exercise session includes a component of aerobic exercise, and activities designed to optimize balance, flexibility, and strength. All study participants will have access to routine follow-up appointments with their respiratory physician, and additional health care providers as part of their usual care. Assessments will be completed at baseline (post-PR), 6, and 12 months, and include measures of functional exercise capacity, quality of life, self-efficacy, and health care usage. Intervention effectiveness will be assessed by comparing functional exercise capacity between intervention and control groups. A mixed-methods process evaluation will be conducted to better understand intervention implementation, guided by Normalization Process Theory and the Consolidated Framework for Implementation Research. Based on results from our pilot work, we anticipate a maintenance of exercise capacity and improved health-related quality of life in the intervention group, compared with a decline in exercise capacity in the usual care group. Findings from this study will improve our understanding of the effectiveness of community-based exercise programs for maintaining benefits following PR in patients with COPD and provide information on how best

  8. From rehabilitation to recovery: protocol for a randomised controlled trial evaluating a goal-based intervention to reduce depression and facilitate participation post-stroke.

    Science.gov (United States)

    Graven, Christine; Brock, Kim; Hill, Keith; Ames, David; Cotton, Susan; Joubert, Lynette

    2011-06-18

    There is much discourse in healthcare about the importance of client-centred rehabilitation, however in the realm of community-based therapy post-stroke there has been little investigation into the efficacy of goal-directed practice that reflects patients' valued activities. In addition, the effect of active involvement of carers in such a rehabilitation process and their subsequent contribution to functional and emotional recovery post-stroke is unclear. In community based rehabilitation, interventions based on patients' perceived needs may be more likely to alter such outcomes. In this paper, we describe the methodology of a randomised controlled trial of an integrated approach to facilitating patient goal achievement in the first year post-stroke. The effectiveness of this intervention in reducing the severity of post-stroke depression, improving participation status and health-related quality of life is examined. The impact on carers is also examined. Patients (and their primary carers, if available) are randomly allocated to an intervention or control arm of the study. The intervention is multimodal and aims to screen for adverse stroke sequelae and address ways to enhance participation in patient-valued activities. Intervention methods include: telephone contacts, written information provision, home visitation, and contact with treating health professionals, with further relevant health service referrals as required. The control involves treatment as usual, as determined by inpatient and community rehabilitation treating teams. Formal blinded assessments are conducted at discharge from inpatient rehabilitation, and at six and twelve months post-stroke. The primary outcome is depression. Secondary outcome measures include participation and activity status, health-related quality of life, and self-efficacy. The results of this trial will assist with the development of a model for community-based rehabilitation management for stroke patients and their carers

  9. European randomized lung cancer screening trials: Post NLST

    DEFF Research Database (Denmark)

    Field, JK; Klaveren, R; Pedersen, JH

    2013-01-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects...

  10. Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia.

    Science.gov (United States)

    Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

    2014-01-01

    In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health

  11. Post hoc subgroups in clinical trials: Anathema or analytics?

    Science.gov (United States)

    Weisberg, Herbert I; Pontes, Victor P

    2015-08-01

    There is currently much interest in generating more individualized estimates of treatment effects. However, traditional statistical methods are not well suited to this task. Post hoc subgroup analyses of clinical trials are fraught with methodological problems. We suggest that the alternative research paradigm of predictive analytics, widely used in many business contexts, can be adapted to help. We compare the statistical and analytics perspectives and suggest that predictive modeling should often replace subgroup analysis. We then introduce a new approach, cadit modeling, that can be useful to identify and test individualized causal effects. The cadit technique is particularly useful in the context of selecting from among a large number of potential predictors. We describe a new variable-selection algorithm that has been applied in conjunction with cadit. The cadit approach is illustrated through a reanalysis of data from the Randomized Aldactone Evaluation Study trial, which studied the efficacy of spironolactone in heart-failure patients. The trial was successful, but a serious adverse effect (hyperkalemia) was subsequently discovered. Our reanalysis suggests that it may be possible to predict the degree of hyperkalemia based on a logistic model and to identify a subgroup in which the effect is negligible. Cadit modeling is a promising alternative to subgroup analyses. Cadit regression is relatively straightforward to implement, generates results that are easy to present and explain, and can mesh straightforwardly with many variable-selection algorithms. © The Author(s) 2015.

  12. Evaluation of patient-rated stiffness associated with fibromyalgia: a post-hoc analysis of 4 pooled, randomized clinical trials of duloxetine.

    Science.gov (United States)

    Bennett, Robert; Russell, I Jon; Choy, Ernest; Spaeth, Michael; Mease, Philip; Kajdasz, Daniel; Walker, Daniel; Wang, Fujun; Chappell, Amy

    2012-04-01

    Patients with fibromyalgia (FM) rate stiffness as one of the most troublesome symptoms of the disorder. However, there are few published studies that have focused on better understanding the nature of stiffness in FM. The primary objectives of these analyses were to characterize the distribution of stiffness severity in patients at baseline, evaluate changes in stiffness after 12 weeks of treatment with duloxetine, and determine which outcomes were correlated with stiffness. These were post-hoc analyses of 3-month data from 4 randomized, double-blind, placebo-controlled studies that assessed efficacy of duloxetine in adults with FM. Severity of stiffness was assessed by using the Fibromyalgia Impact Questionnaire (FIQ) on a scale from 0 (no stiffness) to 10 (most severe stiffness). The association between changes in stiffness and other measures was evaluated by using Pearson's correlation coefficient. The FIQ total score and items, the Brief Pain Inventory (BPI-modified short form), the Clinical Global Impression-Severity scale, the Multidimensional Fatigue Inventory, the 17-item Hamilton Depression Rating Scale, the Sheehan Disability Scale, the 36-item Short-Form Health Survey, and the EuroQoL Questionnaire-5 Dimensions were evaluated in the correlation analyses. Stepwise linear regression was used to identify the variables that were most highly predictive of the changes in FIQ stiffness. The analysis included 1332 patients (mean age, 50.2 years; 94.7% female; and 87.8% white). The mean (SD) baseline FIQ stiffness score was 7.7 (2.0), and this score correlated with baseline BPI pain score and FIQ function. Duloxetine significantly improved the FIQ stiffness score compared with placebo (P FIQ pain and interference scores, FIQ nonrefreshing sleep, FIQ anxiety, 36-item Short-Form Health Survey bodily pain, and Sheehan Disability Scale total score. Variables related to severity of pain, pain interfering with daily activities, and physical functioning were predictors

  13. Prospective randomized trial for the evaluation of the efficacy of low vs. high dose I-131 for post operative remnant ablation in differentiated thyroid cancer

    International Nuclear Information System (INIS)

    Barrenechea, E.A.; Laureta, E.G.; Gaston, J.C.; Al-Nahhas, A.; Padhy, A.K.

    2005-01-01

    The study was done under the auspices of the IAEA to evaluate the efficacy of low dose (50-60mCi) vs. High dose (100 mCi) for the post-operative remnant ablation of differentiated thyroid cancer and to determine other factors associated with successful ablation. There were eighty-six patients included in the study with a diagnosis of papillary, follicular or mixed type of thyroid cancer. They all have undergone near total thyroidectomy or total thyroidectomy and without any evidence of metastatic disease. Four to six weeks after the surgery and without thyroid hormone maintenance as well as iodine free diet and drugs, they underwent a total body scan and uptake using 1-3 mci of I-131. Serum TSH and thyroglobulin were also taken. Randomization was made thru the IAEA and the patients either got a low dose or a high dose depending on such randomization. Of the 86 patients included, there were a total of 76 evaluable cases. There were three dropouts because of other medical conditions as upper GI bleeding, lung cancer and leg fracture. The 7 other patients have not completed their follow-up body scan. Among these patients were 67 females and 19 males whose age range was 19 to 84 years old. There were 65 cases with histologic type of papillary cancer, 15 follicular and 6 mixed varieties. Forty-one patients were randomized to the high dose group while 35 patients were assigned to the low dose therapy group. These patients were confined till their radiation activity was below 2mR/hr. Monitoring of the patients were done during their hospital stay. Post-therapy body scan was done but not with all patients. Most of the side effects noted were sialitis, mild neck pains, nausea and occasional vomiting as well as ageusia. These patients were maintained on thyroid hormone depending on their sensitivity but almost all were given 200-300mgs per day. The older patients tolerated only around 150mcgs/day. After four to six months, serum TSH, thyroglobulin and total body scan were

  14. Evaluation of HPV type-replacement in unvaccinated and vaccinated adolescent females-Post-hoc analysis of a community-randomized clinical trial (II).

    Science.gov (United States)

    Gray, Penelope; Palmroth, Johanna; Luostarinen, Tapio; Apter, Dan; Dubin, Gary; Garnett, Geoff; Eriksson, Tiina; Natunen, Kari; Merikukka, Marko; Pimenoff, Ville; Söderlund-Strand, Anna; Vänskä, Simopekka; Paavonen, Jorma; Pukkala, Eero; Dillner, Joakim; Lehtinen, Matti

    2018-06-15

    Efficacy of human papillomavirus (HPV) vaccines promises to control HPV infections. However, HPV vaccination programs may lay bare an ecological niche for non-vaccine HPV types. We evaluated type-replacement by HPV type and vaccination strategy in a community-randomized trial executed in HPV vaccination naïve population. Thirty-three communities were randomized to gender-neutral vaccination with AS04-adjuvanted HPV16/18 vaccine (Arm A), HPV vaccination of girls and hepatitis B-virus (HBV) vaccination of boys (Arm B) and gender-neutral HBV vaccination (Arm C). Resident 1992-95 born boys (40,852) and girls (39,420) were invited. 11,662 boys and 20,513 girls were vaccinated with 20-30% and 45-48% coverage, respectively. HPV typing of 11,396 cervicovaginal samples was performed by high throughput PCR. Prevalence ratios (PR) between arms and ranked order of HPV types and odds ratio (OR) for having multiple HPV types in HPV16 or 18/45 positive individuals were calculated. The ranked order of HPV types did not significantly differ between arms or birth cohorts. For the non-HPV vaccinated 1992-1993 birth cohorts increased PR, between the gender-neutral intervention versus control arms for HPV39 (PR A 1.84, 95% CI 1.12-3.02) and HPV51 (PR A 1.56, 95% CI 1.11-2.19) were observed. In the gender-neutral arm, increased clustering between HPV39 and the vaccine-covered HPV types 16 or 18/45 (OR A16  = 5.1, OR A18/45  = 11.4) was observed in the non-HPV vaccinated 1994-1995 birth cohorts. Comparable clustering was seen between HPV51 and HPV16 or HPV18/45 (OR B16  = 4.7, OR B18/45  = 4.3), in the girls-only arm. In conclusion, definitively consistent postvaccination patterns of HPV type-replacement were not observed. Future occurrence of HPV39 and HPV51 warrant investigation. © 2018 UICC.

  15. Evaluation Using Sequential Trials Methods.

    Science.gov (United States)

    Cohen, Mark E.; Ralls, Stephen A.

    1986-01-01

    Although dental school faculty as well as practitioners are interested in evaluating products and procedures used in clinical practice, research design and statistical analysis can sometimes pose problems. Sequential trials methods provide an analytical structure that is both easy to use and statistically valid. (Author/MLW)

  16. Cost-utility analysis of a one-time supervisor telephone contact at 6-weeks post-partum to prevent extended sick leave following maternity leave in The Netherlands: results of an economic evaluation alongside a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Poppel Mireille NM

    2011-01-01

    Full Text Available Abstract Background Working women of childbearing age are a vital part of the population. Following childbirth, this group of women can experience a myriad of physical and mental health problems that can interfere with their ability to work. Currently, there is little known about cost-effective post-partum interventions to prevent work disability. The purpose of the study was to evaluate whether supervisor telephone contact (STC during maternity leave is cost-effective from a societal perspective in reducing sick leave and improving quality-adjusted life years (QALYs compared to common practice (CP. Methods We conducted an economic evaluation alongside a randomized controlled trial. QALYs were measured by the EuroQol 5-D, and sick leave and presenteeism by the Health and work Performance Questionnaire. Resource use was collected by questionnaires. Data were analysed according to intention-to-treat. Missing data were imputed via multiple imputation. Uncertainty was estimated by 95% confidence intervals, cost-utility planes and curves, and sensitivity analyses. Results 541 working women from 15 companies participated. Response rates were above 85% at each measurement moment. At the end of the follow-up, no statistically significant between-group differences in QALYs, mean hours of sick leave or presenteeism or costs were observed. STC was found to be less effective and more costly. For willingness-to-pay levels from €0 through €50,000, the probability that STC was cost-effective compared to CP was 0.2. Overall resource use was low. Mean total costs were €3678 (95% CI: 3386; 3951. Productivity loss costs represented 37% of the total costs and of these costs, 48% was attributable to sick leave and 52% to work presenteeism. The cost analysis from a company's perspective indicated that there was a net cost associated with the STC intervention. Conclusions STC was not cost-effective compared to common practice for a healthy population of working

  17. [In vivo evaluation of carbon fiber posts].

    Science.gov (United States)

    Lai, V; Lugliè, P F; Chessa, G

    2002-05-01

    The use of carbon fiber posts allows morpho-functional restoration of endodontically treated teeth with an assembly of materials of a modulus of elasticity similar to that of dentin. The study clinically evaluated the percentage of survival of dental elements treated and reconstructed with endocanal carbon fiber posts. At the Dentistry Clinic of the University of Sassari 60 dental elements were selected from 46 subjects. The teeth, which had been treated endodontically with success for at least six months, were classified by parameters taken from the international literature and reconstructed using Tech 2000 carbon fiber posts and adhesive resinous systems recommended by the post manufacturer. The success rate was 98.4%. Almost half (49%) of the samples were single-rooted elements, 37.4% of the posts were 1.2 mm in diameter; in 78.3% the opposing contact was with a natural tooth; 100% of the elements had a type A dental structure. Third generation posts are a valid alternative to metallic posts and improve the prognosis of the treated element. The carbon fiber posts fixed with the composite, forming a single unit with the dental element, thus improving mid-term RESULTS. The technique is easy to use under clinical conditions and can be performed in a single session. So far, the method has provided promising clinical results, as this study demonstrated.

  18. The Post-Discharge Network Coordination Programme (PDNC-P: A randomised controlled trial to evaluate the efficacy of an intervention aimed at reducing rehospitalisations and improving mental health

    Directory of Open Access Journals (Sweden)

    Michael Pascal Hengartner

    2016-03-01

    Full Text Available Purpose: To evaluate the efficacy of a post-discharge intervention for psychiatric inpatients aimed at preventing hospital readmissions and at improving patients’ mental health and psychosocial functioning. Methods: RCT using parallel group block randomisation including 151 patients with ≤3 hospitalisations within the last three years, a GAF score ≤60, and aged 18–64 years, assessed at two psychiatric hospitals from the canton of Zurich, Switzerland, between September 2011 and February 2014. Primary outcomes were rate and duration of rehospitalisation; secondary outcomes were mental health and functioning. Outcome measures were assessed before discharge from the index hospitalisation (t0, 3 months after discharge when the intervention terminated (t1, and 12 months after discharge (t2. Participants received either a brief case management post-discharge intervention or treatment as usual.Results: In the short-term (i.e., t0-t1 no significant effect emerged in any outcome. In the long-term (i.e., t0-t2 the two groups did not differ significantly with respect to the rate and duration of rehospitalisation. Also, the intervention did not reduce psychiatric symptoms, did not improve social support and did not improve quality of life. However, it did slightly increase assessor-rated general (d=0.30 and social functioning (d=0.42, although self-reports revealed a deteriorative effect on symptom remission (d=-0.44.Conclusions: This psychosocial post-discharge intervention showed no efficacy in the primary outcome of rehospitalisation. With respect to secondary outcomes, in the long-term it might lead to slightly increased social functioning but revealed no significant effect on psychopathology, social support and quality of life. In contrast, with respect to self-reported symptom remission, it was revealed to have a negative effect. In this high-resource catchment area with comprehensive community psychiatric and social services the intervention

  19. Travel websites: Changing visits, evaluations and posts

    NARCIS (Netherlands)

    Bronner, Fred; de Hoog, Robert

    2016-01-01

    Many studies concerning the role of web-based information in tourism measure one-time interactions. This paper presents results of a longitudinal study. Data collected in 2014 about website visits, evaluations and posts, are compared with data from 2007. The main finding is the advance of sites

  20. Post-Occupancy Evaluation of Facilities Change

    NARCIS (Netherlands)

    van der Voordt, Theo; de Been, I.; Maarleveld, M.; Finch, E

    2012-01-01

    This chapter discusses possible aims, tools and deliverables of Post-Occupancy Evaluations (POE) (otherwise known as building-in-use studies), with a focus on interventions in supporting facilities. POE has a long tradition and has been applied in different fields (e.g. offices, educational

  1. Cost-utility analysis of a one-time supervisor telephone contact at 6-weeks post-partum to prevent extended sick leave following maternity leave in The Netherlands: results of an economic evaluation alongside a randomized controlled trial.

    Science.gov (United States)

    Uegaki, Kimi; Stomp-van den Berg, Suzanne G M; de Bruijne, Martine C; van Poppel, Mireille N M; Heymans, Martijn W; van Mechelen, Willem; van Tulder, Maurits W

    2011-01-27

    Working women of childbearing age are a vital part of the population. Following childbirth, this group of women can experience a myriad of physical and mental health problems that can interfere with their ability to work. Currently, there is little known about cost-effective post-partum interventions to prevent work disability. The purpose of the study was to evaluate whether supervisor telephone contact (STC) during maternity leave is cost-effective from a societal perspective in reducing sick leave and improving quality-adjusted life years (QALYs) compared to common practice (CP). We conducted an economic evaluation alongside a randomized controlled trial. QALYs were measured by the EuroQol 5-D, and sick leave and presenteeism by the Health and work Performance Questionnaire. Resource use was collected by questionnaires. Data were analysed according to intention-to-treat. Missing data were imputed via multiple imputation. Uncertainty was estimated by 95% confidence intervals, cost-utility planes and curves, and sensitivity analyses. 541 working women from 15 companies participated. Response rates were above 85% at each measurement moment. At the end of the follow-up, no statistically significant between-group differences in QALYs, mean hours of sick leave or presenteeism or costs were observed. STC was found to be less effective and more costly. For willingness-to-pay levels from €0 through €50,000, the probability that STC was cost-effective compared to CP was 0.2. Overall resource use was low. Mean total costs were €3678 (95% CI: 3386; 3951). Productivity loss costs represented 37% of the total costs and of these costs, 48% was attributable to sick leave and 52% to work presenteeism. The cost analysis from a company's perspective indicated that there was a net cost associated with the STC intervention. STC was not cost-effective compared to common practice for a healthy population of working mothers; therefore, implementation is not indicated. The cost

  2. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.

    Science.gov (United States)

    Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

    2014-09-19

    To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

  3. Adaptation of adhesive post and cores to dentin after in vitro occlusal loading: evaluation of post material influence.

    Science.gov (United States)

    Dietschi, Dider; Ardu, Stefano; Rossier-Gerber, Anne; Krejci, Ivo

    2006-12-01

    Fatigue resistance of post and cores is critical to the long term behavior of restored nonvital teeth. The purpose of this in vitro trial was to evaluate the influence of the post material's physical properties on the adaptation of adhesive post and core restorations after cyclic mechanical loading. Composite post and cores were made on endodontically treated deciduous bovine teeth using 3 anisotropic posts (made of carbon, quartz, or quartz-and-carbon fibers) and 3 isotropic posts (zirconium, stainless steel, titanium). Specimens were submitted to 3 successive loading phases--250,000 cycles at 50 N, 250,000 at 75 N, and 500,000 at 100 N--at a rate of 1.5 Hz. Restoration adaptation was evaluated under SEM, before and during loading (margins) and after test completion (margins and internal interfaces). Six additional samples were fabricated for the characterization of interface micromorphology using confocal microscopy. Mechanical loading increased the proportion of marginal gaps in all groups; carbon fiber posts presented the lowest final gap proportion (7.11%) compared to other stiffer metal-ceramic or softer fiber posts (11.0% to 19.1%). For internal adaptation, proportions of debonding between dentin and core or cement varied from 21.69% (carbon post) to 47.37% (stainless steel post). Debonding at the post-cement interface occurred only with isotropic materials. Confocal microscopy observation revealed that gaps were generally associated with an incomplete hybrid layer and reduced resin tags. Regardless of their rigidity, metal and ceramic isotropic posts proved less effective than fiber posts at stabilizing the post and core structure in the absence of the ferrule effect, due to the development of more interfacial defects with either composite or dentin.

  4. Imaging evaluation of post pancreatic surgery

    International Nuclear Information System (INIS)

    Scialpi, Michele; Scaglione, Mariano; Volterrani, Luca; Lupattelli, Luciano; Ragozzino, Alfonso; Romano, Stefania; Rotondo, Antonio

    2005-01-01

    The role of several imaging techniques in patients submitted to pancreatic surgery with special emphasis to single-slice helical computed tomography (CT) and multidetector-row CT (MDCT) was reviewed. Several surgical options may be performed such as Whipple procedure, distal pancreatectomy, central pancreatectomy, and total pancreatectomy. Ultrasound examination may be used to detect peritoneal fluid in the early post-operative period as well as lesion recurrence in long-term follow-up. Radiological gastrointestinal studies has a major role in evaluation of intestinal functionality. In spite of the advent of other imaging modalities, CT is the most effective after pancreatic surgery. On post-operative CT, the most common findings were small fluid peritoneal or pancreatic collections, stranding of the mesenteric fat with perivascular cuffing, reactive adenopathy and pneumobilia. In addition, CT may demonstrate early (leakage of anastomosis, pancreatico-jejunal fistula, haemorrage, acute pancreatitis of the remnant pancreas, peritonitis), and late (chronic fistula, abscess, aneurysms, anastomotic bilio-digestive stenosis, perianastomotic ulcers, biloma, and intra-abdominal bleeding) surgical complications. In the follow-up evaluation, CT may show tumor recurrence, liver and lymph nodes metastasis. Magnetic resonance may be used as alternative imaging modality to CT, when renal insufficiency or contrast sensitivity prevents the use of iodinated i.v. contrast material or when the biliary tree study is primarily requested. The knowledge of the type of surgical procedures, the proper identification of the anastomoses as well as the normal post-operative imaging appearances are essential for an accurate detection of the complications and recurrent disease

  5. Imaging evaluation of post pancreatic surgery

    Energy Technology Data Exchange (ETDEWEB)

    Scialpi, Michele [Department of Radiology, ' Santissima Annunziata' Hospital, Via Bruno 1, I-74100 Taranto (Italy)]. E-mail: michelescialpi@libero.it; Scaglione, Mariano [Department of Radiology, ' A. Cardarelli' Hospital, I-80131 Naples (Italy); Volterrani, Luca [Institute of Radiology, University of Siena, I-53100 Siena (Italy); Lupattelli, Luciano [Institute of Radiology, University of Perugia, I-06122 Perugia (Italy); Ragozzino, Alfonso [Department of Radiology, ' A. Cardarelli' Hospital, I-80131 Naples (Italy); Romano, Stefania [Department of Radiology, ' A. Cardarelli' Hospital, I-80131 Naples (Italy); Rotondo, Antonio [Section of Radiology, Department ' Magrassi-Lanzara' , Second University, I-80138 Naples (Italy)

    2005-03-01

    The role of several imaging techniques in patients submitted to pancreatic surgery with special emphasis to single-slice helical computed tomography (CT) and multidetector-row CT (MDCT) was reviewed. Several surgical options may be performed such as Whipple procedure, distal pancreatectomy, central pancreatectomy, and total pancreatectomy. Ultrasound examination may be used to detect peritoneal fluid in the early post-operative period as well as lesion recurrence in long-term follow-up. Radiological gastrointestinal studies has a major role in evaluation of intestinal functionality. In spite of the advent of other imaging modalities, CT is the most effective after pancreatic surgery. On post-operative CT, the most common findings were small fluid peritoneal or pancreatic collections, stranding of the mesenteric fat with perivascular cuffing, reactive adenopathy and pneumobilia. In addition, CT may demonstrate early (leakage of anastomosis, pancreatico-jejunal fistula, haemorrage, acute pancreatitis of the remnant pancreas, peritonitis), and late (chronic fistula, abscess, aneurysms, anastomotic bilio-digestive stenosis, perianastomotic ulcers, biloma, and intra-abdominal bleeding) surgical complications. In the follow-up evaluation, CT may show tumor recurrence, liver and lymph nodes metastasis. Magnetic resonance may be used as alternative imaging modality to CT, when renal insufficiency or contrast sensitivity prevents the use of iodinated i.v. contrast material or when the biliary tree study is primarily requested. The knowledge of the type of surgical procedures, the proper identification of the anastomoses as well as the normal post-operative imaging appearances are essential for an accurate detection of the complications and recurrent disease.

  6. Solid oxide fuel cell field trial evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Wilcox, C.P.; Winstanley, R.; Nietsch, T.; Smith, C.; Knight, R.; Seymore, C.

    2000-07-01

    This report focuses on issues relating to a field trial of a solid oxide fuel cell (SOFC). Aspects examined include markets for SOFC systems, the choice of systems for demonstration in year 2002, the assessment of industrial interest, and evaluation and ranking of candidate systems. The identification and evaluation of interest in field trials, the estimation of the capital and running costs of a field trial, and identification of the benefits to the UK and barriers to implementation of SOFC systems are discussed. (UK)

  7. Post-trial obligations in the Declaration of Helsinki 2013: classification, reconstruction and interpretation.

    Science.gov (United States)

    Mastroleo, Ignacio

    2016-08-01

    The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of 'Post-trial provisions' is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous 'fair benefit' language. However, I criticize the disappearance of 'access to other appropriate care' present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. © 2015 John Wiley & Sons Ltd.

  8. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial

    Science.gov (United States)

    Rushton, Alison; Goodwin, Peter C.

    2015-01-01

    Objectives To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components. Design and Setting A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres. Participants Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy. Interventions Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone. Main Outcome Measures Blinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation. Results At discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported. Conclusions Both interventions were acceptable, and it is promising that they both

  9. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  10. Intravenous iron vs blood for acute post-partum anaemia (IIBAPPA): a prospective randomised trial.

    Science.gov (United States)

    Chua, Seng; Gupta, Sarika; Curnow, Jennifer; Gidaszewski, Beata; Khajehei, Marjan; Diplock, Hayley

    2017-12-19

    Acute post-partum anaemia can be associated with significant morbidity including a predisposition for postnatal depression. Lack of clear practice guidelines means a number of women are treated with multiple blood transfusions. Intravenous iron has the potential to limit the need for multiple blood transfusions but its role in the post-partum setting is unclear. IIBAPPA is a multi-centre randomised non-inferiority trial. Women with a primary post-partum haemorrhage (PPH) >1000 mL and resultant haemoglobin (Hb) 5.5-8.0 g/dL after resuscitation with ongoing symptomatic anaemia who are otherwise stable (no active bleeding) are eligible to participate. Patients with sepsis or conditions necessitating rapid Hb restoration are excluded. Eligible participants are randomised to receive a blood transfusion or a single dose of intravenous iron polymaltose calculated using the Ganzoni formula. Primary outcome measures include Hb, Ferritin and C-Reactive Protein levels on Day 7. Secondary outcomes evaluate (i) Hb, Ferritin and CRP levels on Day 14, 28, (ii) anaemia symptoms on Day 0, 7, 14 and 28 using structured health related quality of life questionnaires, (iii) treatment safety by assessing adverse reactions and infection endpoints and (iv) the quantitative impact of anaemia on breast feeding quality using a hospital designed questionnaire. If equivalence in Hb and ferritin levels, symptom scores and safety endpoints is demonstrated, intravenous iron may become the preferred treatment for women with acute post-partum anaemia to minimise transfusion reactions and costs. Australian and New Zealand Clinical Trials Registry: ACTRN12615001370594 on 16th December, 2015 (prospective approval).

  11. Low degree of satisfactory individual pain relief in post-operative pain trials

    DEFF Research Database (Denmark)

    Geisler, A; Dahl, J B; Karlsen, A P H

    2017-01-01

    BACKGROUND: The majority of clinical trials regarding post-operative pain treatment focuses on the average analgesic efficacy, rather than on efficacy in individual patients. It has been argued, that in acute pain trials, the underlying distributions are often skewed, which makes the average unfi...

  12. Treatment of post-myocardial infarction depressive disorder : A randomized, placebo-controlled trial with mirtazapine

    NARCIS (Netherlands)

    Honig, Adriaan; Kuyper, Astrid M. G.; Schene, Aart H.; van Melle, Joost P.; De Jonge, Peter; Tulner, Dorien M.; Schins, Annique; Crijns, Harry J. G. M.; Kuijpers, Petra M. J. C.; Vossen, Helen; Lousberg, Richel; Ormel, Johan

    Objective: To examine the antidepressant efficacy of a dual-acting antidepressant (mirtazapine) in patients with post-myocardial infarction (MI) depressive disorder. Antidepressants used in post MI trials with a randomized, double-blind, placebo-controlled design have been restricted to selective

  13. Evaluating the Effects of Interactivity in a Post-Editing Workbench

    DEFF Research Database (Denmark)

    Underwood, Nancy; Mesa-Lao, Bartolomé; Martinez, Mercedes Garcia

    2014-01-01

    This paper describes the field trial and subsequent evaluation of a post-editing workbench which is currently under development in the EU-funded CasMaCat project. Based on user evaluations of the initial prototype of the workbench, this second prototype of the workbench includes a number of inter...... on productivity, quality, user satisfaction and cognitive load as reflected in the post-editors’ gaze activity. These quantitative results are combined with the qualitative results derived from user questionnaires and interviews conducted with all the participants....

  14. Gabapentin May Relieve Post-Coronary Artery Bypass Graft Pain: A Double Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    MSoltanzadeh

    2011-09-01

    Full Text Available Background: One of the most common complaints after coronary artery bypass graft (CABG is post-operative pain. Gabapentin is an anticonvulsant and antineuralgic agent. Objective: To evaluate the analgesic effect of preemptive gabapentin on post-operative pain and morphine consumption after cardiac surgery. Methods: A double-blind randomized clinical trial was conducted on 60 male candidates for CABG. The patients were divided into two groups—the gabapentin (n=30 and the control group (n=30. The test group received 800 mg gabapentin orally two hours before the surgery followed by 400 mg of the drug two hours post-extubation. The control group received placebo instead. Then severity of pain was recorded according to an 11-point visual analog pain scale. The amount of morphine consumed, its side effects and hemodynamic changes were also recorded during and at 2, 6, 12, 18 and 24 hours after extubation. Results: The mean±SD cumulative morphine consumption at the first 24 hours after extubation in gabapentin group was 0.9±1.5 mg while it was 1.5±4 mg for the control group. Therefore, gabapentin group consumed 38% less than the control group (P=0.01. The pain scores during rest and coughing at 2, 6, and 12 hours after extubation were also significantly lower in the gabapentin group compared with the control group (P=0.02. The mean±SD mechanical ventilation time was 5.4±1.7 hours for gabapentin group and 1.6±4.4 hours for the control group (P=0.035. The other variables including hemodynamic changes (HR, SBP and DBP, and incidence of nausea, vomiting and respiratory depression showed no significant difference between the studied groups within 24 hours after extubation. Conclusion: Oral pre-medication with gabapentin before CABG significantly reduces post-operative pain and morphine consumption in adult cardiac surgery.

  15. Low degree of satisfactory individual pain relief in post-operative pain trials.

    Science.gov (United States)

    Geisler, A; Dahl, J B; Karlsen, A P H; Persson, E; Mathiesen, O

    2017-01-01

    The majority of clinical trials regarding post-operative pain treatment focuses on the average analgesic efficacy, rather than on efficacy in individual patients. It has been argued, that in acute pain trials, the underlying distributions are often skewed, which makes the average unfit as the only way to measure efficacy. Consequently, dichotomised, individual responder analyses using a predefined 'favourable' response, e.g. Visual Analogue Scale (VAS) pain scores ≤ 30, have recently been suggested as a more clinical relevant outcome. We re-analysed data from 16 randomised controlled trials of post-operative pain treatment and from meta-analyses of a systematic review regarding hip arthroplasty. The predefined success criterion was that at least 80% of patients in active treatment groups should obtain VAS < 30 at 6 and 24 h post-operatively. In the analysis of data from the randomised controlled trials, we found that at 6 h post-operatively, 50% (95% CI: 31-69) of patients allocated to active treatment reached the success criterion for pain at rest and 14% (95% CI: 5-34) for pain during mobilisation. At 24 h post-operatively, 60% (95% CI: 38-78) of patients allocated to active treatment reached the success criterion for pain at rest, and 15% (95% CI: 5-36) for pain during mobilisation. Similar results were found for trials from the meta-analyses. Our results indicate that for conventional, explanatory trials of post-operative pain, individual patient's achievement of a favourable response to analgesic treatment is rather low. Future pragmatic clinical trials should focus on both average pain levels and individual responder analyses in order to promote effective pain treatment at the individually patient level. © 2016 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  16. Bacteriological And Clinical Evaluation Of Twelve Cases Of Post ...

    African Journals Online (AJOL)

    Bacteriological And Clinical Evaluation Of Twelve Cases Of Post-Surgical Sepsis Of Odontogenic Tumours At A ... East African Medical Journal ... Intervention: Adequate review of patient\\'s medical history, bacteriological investigations and

  17. Ex-post evaluation of tax legislation in the Netherlands

    NARCIS (Netherlands)

    S.J.C. Hemels (Sigrid)

    2011-01-01

    textabstractIntroduction Since the end of the 20th century, ex-post evaluation of tax legislation has consistently been part of the agenda of the Dutch government. In 2005, the 2001 Income tax Act was evaluated. In addition, several tax expenditures are evaluated each year. Tax expenditures can be a

  18. Cystographic evaluation post colocystoplasty in two Nigerian ...

    African Journals Online (AJOL)

    A study was conducted to evaluate “graft-take” in an experimentally reconstructed urinary bladder by colocystoplasty in two adult dogs. Predetermined 2x3 cm dimension of urinary bladder defect was created on the dorsum and the ventrum of the urinary bladder and was patched with harvested 3x6 cm colonic pedicle flap.

  19. Cost-utility analysis of a one-time supervisor telephone contact at 6-weeks post-partum to prevent extended sick leave following maternity leave in The Netherlands: results of an economic evaluation alongside a randomized controlled trial

    NARCIS (Netherlands)

    Uegaki, K.; Stomp-van den Berg, S.G.; de Bruijne, M.C.; van Poppel, M.N.M.; Heymans, M.W.; van Mechelen, W.; van Tulder, M.W.

    2011-01-01

    Background: Working women of childbearing age are a vital part of the population. Following childbirth, this group of women can experience a myriad of physical and mental health problems that can interfere with their ability to work. Currently, there is little known about cost-effective post-partum

  20. Randomized controlled trial of internal and external targeted temperature management methods in post- cardiac arrest patients.

    Science.gov (United States)

    Look, Xinqi; Li, Huihua; Ng, Mingwei; Lim, Eric Tien Siang; Pothiawala, Sohil; Tan, Kenneth Boon Kiat; Sewa, Duu Wen; Shahidah, Nur; Pek, Pin Pin; Ong, Marcus Eng Hock

    2018-01-01

    Targeted temperature management post-cardiac arrest is currently implemented using various methods, broadly categorized as internal and external. This study aimed to evaluate survival-to-hospital discharge and neurological outcomes (Glasgow-Pittsburgh Score) of post-cardiac arrest patients undergoing internal cooling verses external cooling. A randomized controlled trial of post-resuscitation cardiac arrest patients was conducted from October 2008-September 2014. Patients were randomized to either internal or external cooling methods. Historical controls were selected matched by age and gender. Analysis using SPSS version 21.0 presented descriptive statistics and frequencies while univariate logistic regression was done using R 3.1.3. 23 patients were randomized to internal cooling and 22 patients to external cooling and 42 matched controls were selected. No significant difference was seen between internal and external cooling in terms of survival, neurological outcomes and complications. However in the internal cooling arm, there was lower risk of developing overcooling (p=0.01) and rebound hyperthermia (p=0.02). Compared to normothermia, internal cooling had higher survival (OR=3.36, 95% CI=(1.130, 10.412), and lower risk of developing cardiac arrhythmias (OR=0.18, 95% CI=(0.04, 0.63)). Subgroup analysis showed those with cardiac cause of arrest (OR=4.29, 95% CI=(1.26, 15.80)) and sustained ROSC (OR=5.50, 95% CI=(1.64, 20.39)) had better survival with internal cooling compared to normothermia. Cooling curves showed tighter temperature control for internal compared to external cooling. Internal cooling showed tighter temperature control compared to external cooling. Internal cooling can potentially provide better survival-to-hospital discharge outcomes and reduce cardiac arrhythmia complications in carefully selected patients as compared to normothermia. Copyright © 2017. Published by Elsevier Inc.

  1. Clinical characteristics, risk factors and pre-surgical evaluation of post-infectious epilepsy.

    Science.gov (United States)

    Sellner, J; Trinka, E

    2013-03-01

    Epilepsy is a frequent complication of central nervous system (CNS) infections. Post-infectious epilepsy is commonly refractory to medical treatment and plays a pivotal role for the poor long-term outcome of CNS infections. To provide an overview of clinical characteristics and risk factors of seizures associated with CNS infections. In addition, to summarize the state of the art of anticonvulsive treatment and the pre-surgical evaluation process in refractory cases. A comprehensive literature search for articles published between January 1970 and December 2011 was carried out. The occurrence of seizures during the acute course of meningitis, encephalitis and brain abscess is the main risk factor for the development of post-infectious epilepsy. There is a shortage of trials evaluating the efficacy of prophylactic and symptomatic treatment during the course of acute infection. Moreover, there are no randomized-controlled trials studying anticonvulsive drugs and their combinations for the management of post-infectious epilepsy. In a selected group of patients, however, medically refractory focal epilepsy is potentially curable by surgery. Further studies are required to improve the pathogenetic understanding of post-infectious epilepsy in order to develop preventive measures as well as to evaluate additional medical and surgical treatment strategies for the patients currently not considered for surgery. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

  2. Design Alternative Evaluation No. 3: Post-Closure Ventilation

    International Nuclear Information System (INIS)

    Logan, R.C.

    1999-01-01

    The objective of this study is to provide input to the Enhanced Design Alternatives (EDA) for License Application Design Selection (LADS). Its purpose is to develop and evaluate conceptual designs for post-closure ventilation alternatives that enhance repository performance. Post-closure ventilation is expected to enhance repository performance by limiting the amount of water contacting the waste packages. Limiting the amount of water contacting the waste packages will reduce corrosion

  3. A randomized trial of rectal indomethacin and sublingual nitrates to prevent post-ERCP pancreatitis.

    Science.gov (United States)

    Sotoudehmanesh, Rasoul; Eloubeidi, Mohamad Ali; Asgari, Ali Ali; Farsinejad, Maryam; Khatibian, Morteza

    2014-06-01

    Acute pancreatitis is the most common adverse event of endoscopic retrograde cholangiopancreatography (ERCP). Recent data suggest that indomethacin can reduce the risk of post-ERCP pancreatitis (PEP) in high-risk individuals. However, whether the combination of indomethacin and sublingual nitrates is superior to indomethacin alone is unknown. Therefore, we aimed to evaluate the efficacy of rectally administered indomethacin plus sublingual nitrate compared with indomethacin alone to prevent PEP. During a 17-month period, all eligible patients who underwent ERCP were enrolled in this study. We excluded patients who had undergone a prior endoscopic sphincterotomy. In a double-blind controlled randomized trial, patients received a suppository containing 100 mg of indomethacin, plus 5 mg of sublingual nitrate (group A), or a suppository containing 100 mg of indomethacin, plus sublingual placebo (group B), before ERCP. Serum amylase levels and clinically pertinent evaluations were measured in all patients after ERCP. Of the 300 enrolled patients, 150 received indomethacin plus nitrate. Thirty-three patients developed pancreatitis: 10 (6.7%) in group A and 23 (15.3%) in group B (P=0.016, risk ratio=0.39, 95% confidence intervals (CI): 0.18-0.86). More than 80% of the patients were at high risk of developing pancreatitis after ERCP. Absolute risk reduction, relative risk reduction, and number needed to treat for the prevention of PEP were 8.6% (95% CI: 4.7-14.5), 56.2% (95% CI: 50.6-60.8), and 12 (95% CI: 7-22), respectively. Combination of rectal indomethacin and sublingual nitrate given before ERCP was significantly more likely to reduce the incidence of PEP than indomethacin suppository alone. Multicenter trials to confirm these promising findings are needed.

  4. Challenges with participant reimbursement: experiences from a post-trial access study.

    Science.gov (United States)

    Mngadi, Kathryn Therese; Frohlich, Janet; Montague, Carl; Singh, Jerome; Nkomonde, Nelisiwe; Mvandaba, Nomzamo; Ntombeka, Fanelesibonge; Luthuli, Londiwe; Abdool Karim, Quarraisha; Mansoor, Leila

    2015-11-01

    Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention intervention, tried to balance the real-life scenario of no reimbursement for attendance at public sector clinics with that of a trial including some visits that focused on research procedures and others that focused on standard of care procedures. A reduced reimbursement was offered for 'standard of care' visits, meant primarily to cover transport costs to and from the clinic only. This impacted negatively on accrual, retention and participant morale, primarily due to the protracted delay in regulatory approval, during which time, the costs of living, including travel costs had increased. Relevant guidelines were reviewed and institutional policy was updated to incorporate the South African National Health Research Ethics Committee guidelines on reimbursement (taking into account participant time, travel and inconvenience). The reimbursement amount for 'standard of care' visits was increased accordingly. The question remains whether a trial that combines post-trial access with implementation science, with clear benefits for the participants and the provision of above standard medical care, should have reimbursement rates that approach those of a proof-of-concept trial, for 'standard of care' visits. 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/

  5. Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence.

    Science.gov (United States)

    Spence, Patrick; Nel, Annalene; van Niekerk, Neliëtte; Derrick, Tiffany; Wilder, Susan; Devlin, Bríd

    2016-06-05

    Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female HIV transmission. Post-use assay results from three Ring-004 clinical trials showed that of the 25mg drug load, approximately 4mg of dapivirine is released from the matrix ring over a 28-day use period. Data obtained by both in vitro and in vivo studies indicate that dapivirine is released according to a diffusion mechanism, as determined by conformance of both data sets to the Higuchi equation. This, coupled with the low variability associated with batch production over two manufacturing sites and 20 batches of material, provides evidence that post-use ring analysis can contribute to the assessment of adherence to ring use. Limitations of this method include the potential of intra-participant and inter-participant variability and uncertainty associated with measuring the low amount of dapivirine actually released relative to the drug load. Therefore, residual drug levels should not serve as the only direct measurement for microbicide adherence in vaginal ring clinical trials but should preferably be used as part of a multi-pronged approach towards understanding and assessing adherence to vaginal ring use. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  6. Evaluation of Pharmacists' Participation in Post-Admission Ward ...

    African Journals Online (AJOL)

    Objective: The study evaluates pharmacist's perception of and participation in post-admission ward rounds, at the Lagos University Teaching Hospital (LUTH). Method: All the 60 pharmacists covering various units of pharmaceutical services were administered a forty-two element structured questionnaire. Fifty (83.3%) ...

  7. Multicenter evaluation of rectal cancer reimaging post neoadjuvant (MERRION) therapy.

    LENUS (Irish Health Repository)

    Hanly, Ann M

    2014-04-01

    The aim of this study was to evaluate the utility of reimaging rectal cancer post-CRT (chemoradiotherapy) with magnetic resonance (MR) imaging of the pelvis for local staging and computed tomography of thorax, abdomen, and pelvis (CT TAP) to identify distant metastases.

  8. Relationship between post-extraction pain and acute pulpitis: a randomised trial using third molars.

    Science.gov (United States)

    Zhang, Wei; Dai, Yong-Bo; Wan, Peng-Cheng; Xu, Dong-Dong; Guo, Yi; Li, Zhi

    2016-12-01

    The aim of the present study was to examine the relationship between post-extraction pain and acute pulpitis in third molars. This study was a randomised controlled trial. Sixty patients requiring removal of a single maxillary third molar with acute pulpitis were included and randomly divided into two groups: group A (n = 30); and group B (n = 30). In group A, third molars were directly extracted, and group B received endodontic therapy (pulp chamber opening and drainage) and underwent extraction 24 hours later, aiming to eliminate the acute inflammation. Another 30 patients requiring removal of a single maxillary third molar and with the same inclusion criteria but without caries or acute pulpitis were recruited into group C, in which the maxillary third molars were also directly extracted. The level of postoperative pain reported each day among the three groups was statistically evaluated. On the first, second and third days after surgery, there was a statistically significant difference between group A and group B and between group A and group C, but there was no statistically significant difference between group B and group C. The results of the present study indicate that there is more pain when third molars with acute pulpitis are directly removed compared with the pain level of the removal of third molars without acute pulpitis. © 2016 FDI World Dental Federation.

  9. [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Fu, Yingkun; Xie, Yanming

    2011-10-01

    In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

  10. Reducing depressive or anxiety symptoms in post-stroke patients: Pilot trial of a constructive integrative psychosocial intervention

    Science.gov (United States)

    Fang, Yihong; Mpofu, Elias; Athanasou, James

    2017-01-01

    Background: About 30% of stroke survivors clinically have depressive symptoms at some point following stroke and anxiety prevalence is around 20-25%. Objective: The purpose of this brief report is to evaluate a pilot trial of a constructive integrative psychosocial intervention (CIPI) over standard care in post-stroke depression or anxiety. Methods: Patients were randomly assigned to either CIPI (n = 23) or standard care (n = 19). Patients were assessed using the Hospital Anxiety and Depression Scale at the 1st, 3rd, and 6th months to monitor changes of mood. Results: A Wilcoxon signed-rank test indicated that compared to admission baseline, patients with the intervention had significantly normal post-stroke depression symptom levels at the 1st, 3rd, and 6th months (P < 0.005). Conclusion: CIPI appears to be of incremental value in treating depression as well as anxiety in subacute care. PMID:29085269

  11. Evaluating biomarkers for prognostic enrichment of clinical trials.

    Science.gov (United States)

    Kerr, Kathleen F; Roth, Jeremy; Zhu, Kehao; Thiessen-Philbrook, Heather; Meisner, Allison; Wilson, Francis Perry; Coca, Steven; Parikh, Chirag R

    2017-12-01

    A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency. We demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform. In some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.

  12. Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints

    Science.gov (United States)

    Renfro, Lindsay A.; Shi, Qian; Xue, Yuan; Li, Junlong; Shang, Hongwei; Sargent, Daniel J.

    2014-01-01

    Evaluation of candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogacy analyses on trial sub-units (e.g., centers within trials), thereby artificially increasing the trial-level sample size for feasibility of the multi-trial analysis. To date, the practical impact of treating trial sub-units (centers) identically to trials in multi-trial surrogacy analyses remains unexplored, and conditions under which this ad hoc solution may in fact be reasonable have not been identified. We perform a simulation study to identify such conditions, and demonstrate practical implications using a multi-trial dataset of patients with early stage colon cancer. PMID:25061255

  13. The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John

    2013-01-01

    on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post......-hoc nested case-control analysis in the ADVANCE trial in order to examine the association between insulin use and cancer. We encountered several methodological challenges that made the results difficult to interpret, including short duration of exposure of interest, lack of power, and correlation between...... exposure and potential confounders. Considering these challenges, we concluded that using the data would not enlighten the discussion about insulin use and cancer risk and only serve to further complicate any understanding. Therefore, we decided to use our experience to illustrate methodological challenges...

  14. Topical sucralfate in post-adenotonsillectomy analgesia in children: a double-blind randomized clinical trial.

    Science.gov (United States)

    Miura, Mauricio Schreiner; Saleh, Catia; de Andrade, Marina; Assmann, Melina; Ayres, Marcio; Lubianca Neto, José Faibes

    2009-09-01

    Tonsillectomy, with or without adenoidectomy, is one of the most common surgical procedures in pediatric otolaryngology. Despite its relative simplicity, pain is the main cause of morbidity in the postoperative period. We determined the effect of topical sucralfate on reduction of oropharyngeal pain in children submitted to adenotonsillectomy. Secondary outcomes were otalgia, analgesic use, type of diet, secondary bleeding, vomiting, fever, and weight loss. Double-blind, randomized clinical trial. Tertiary hospital. Eighty-two children of both sexes between four and 12 years old submitted to adenotonsillectomy were evaluated. They were allocated to receive topical sucralfate or placebo in intraoperative and postoperative periods four times a day for five days. Pain was measured through faces pain scale. Reduction in oropharyngeal pain was significant with use of sucralfate during five days of evaluation (mean, 95% confidence interval, and P value); day 1: 2.05, 1.53-2.58, P = 0.000; day 2: 2.1, 1.51-2.70, P = 0.001; day 3: 1.44, 0.88-1.99, P = 0.003; day 4: 1.13, 0.58-1.55, P = 0.027; day 5: 0.67, 0.26-1.04, P = 0.021). There was no difference in secondary outcomes. We found beneficial effect of use of sucralfate in reduction of oropharyngeal pain in the postoperative period of adenotonsillectomy. However, topical sucralfate does not have a potent effect to the point of being utilized as a single analgesic treatment. Because it is simple, safe, tolerated, and low-cost, it is an important tool as adjuvant treatment of post-tonsillectomy pain.

  15. REM Desensitization as a New Therapeutic Method for Post- Traumatic Stress Disorder: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Khodabakhsh Ahmadi

    2016-05-01

    Full Text Available Aim: to evaluate potential efficacy of a new therapeutic approach in posttraumatic stress disorder in comparison with eye movement desensitization and reprocessing (EMDR, a standard treatment approach and controls. Methods: the study was designed using a randomized controlled trial methodology. Participants were recruited from military servicemen aged between 25 to 50 years who were admitting hospitals of Bushehr, Iran, with the final diagnosis of PTSD. Finally 33 male patients were devided into three subgroups: G1: EMDR; G2: REM Desensitization; and group 3: controls who received no therapy. Mississippi Scale for Posttraumatic Stress Disorder, Pittsburgh Sleep Quality Index (PSQI and a 37 item death anxiety questionnaire were used for measures. Results: multiple comparisons showed that intrusive thoughts were significantly more likely to improve with REM Desensitization versus EMDR (P=0.03, while depression was more responsive to EMDR (p=0.03. Among the Pittsburgh scale for the quality of sleep items, sleep quality (p=0.02, sleep duration (p=0.001, and total sleep quality score (p=0.002 were significantly more likely to improve in the REM Desensitization group. Change in the absolute death anxiety scores was not different between subgroups excepting EMDR versus control group (p=0.05. Conclusion: REM, desensitization, the new therapeutic approach to PTSD is a highly effective strategy, even more than EMDR, the standard treatment, in most of the evaluated subjects, with special emphasis on sleep symptoms, and also in the management of intrusive thoughts. Depression is the only factor in which, REM Desensitization was significantly less likely to represent a superior therapeutic effect than EMDR. Key words: post traumatic stress disorder (PTSD, eye movement desensitization and reprocessing, new treatment.

  16. Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

    Science.gov (United States)

    Kahn, Susan R.; Shrier, Ian; Shapiro, Stan; Houweling, Adrielle H.; Hirsch, Andrew M.; Reid, Robert D.; Kearon, Clive; Rabhi, Khalil; Rodger, Marc A.; Kovacs, Michael J.; Anderson, David R.; Wells, Philip S.

    2011-01-01

    Background Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Methods Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Results Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change −3.6, SD 3.7 v. control mean change −1.6, SD 4.3; difference −2.0, 95% CI −4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Interpretation Exercise training may improve post

  17. Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial

    Science.gov (United States)

    Pirotta, Marie; Gunn, Jane; Chondros, Patty; Grover, Sonia; O'Malley, Paula; Hurley, Susan; Garland, Suzanne

    2004-01-01

    Objective To test whether oral or vaginal lactobacillus can prevent vulvovaginitis after antibiotic treatment. Design Randomised, placebo controlled, double blind, factorial 2×2 trial. Setting Fifty general practices and 16 pharmacies in Melbourne, Australia. Participants Non-pregnant women aged 18-50 years who required a short course of oral antibiotics for a non-gynaecological infection: 278 were enrolled in the study, and results were available for 235. Interventions Lactobacillus preparations taken orally or vaginally, or both, from enrolment until four days after completion of their antibiotic course. Main outcome measures Participants' reports of symptoms of post-antibiotic vulvovaginitis, with microbiological evidence of candidiasis provided by a self obtained vaginal swab. Results Overall, 55/235 (23% (95% confidence interval 18% to 29%)) women developed post-antibiotic vulvovaginitis. Compared with placebo, the odds ratio for developing post-antibiotic vulvovaginitis with oral lactobacillus was 1.06 (95% confidence interval 0.58 to 1.94) and with vaginal lactobacillus 1.38 (0.75 to 2.54). Compliance with antibiotics and interventions was high. The trial was terminated after the second interim analysis because of lack of effect of the interventions. Given the data at this time, the chances of detecting a significant reduction in vulvovaginitis with oral or vaginal lactobacillus treatment were less than 0.032 and 0.0006 respectively if the trial proceeded to full enrolment. Conclusions The use of oral or vaginal forms of lactobacillus to prevent post-antibiotic vulvovaginitis is not supported by these results. Further research on this subject is unlikely to be fruitful, unless new understandings about the pathogenesis of post-antibiotic vulvovaginitis indicate a possible role for lactobacillus. PMID:15333452

  18. Dynamic MRI evaluation of urethral hypermobility post-radical prostatectomy.

    Science.gov (United States)

    Suskind, Anne M; DeLancey, John O L; Hussain, Hero K; Montgomery, Jeffrey S; Latini, Jerilyn M; Cameron, Anne P

    2014-03-01

    One postulated cause of post-prostatectomy incontinence is urethral and bladder neck hypermobility. The objective of this study was to determine the magnitude of anatomical differences of urethral and bladder neck position at rest and with valsalva in continent and incontinent men post-prostatectomy based on dynamic MRI. All subjects underwent a dynamic MRI protocol with valsalva and non-valsalva images and a standard urodynamic evaluation. MRI measurements were taken at rest and with valsalva, including (1) bladder neck to sacrococcygeal inferior pubic point line (SCIPP), (2) urethra to pubis, and (3) bulbar urethra to SCIPP. Data were analyzed in SAS using two-tailed t tests. A total of 21 subjects (13 incontinent and 8 continent) had complete data and were included in the final analysis. The two groups had similar demographic characteristics. On MRI, there were no statistically significant differences in anatomic position of the bladder neck or urethra either at rest or with valsalva. The amount of hypermobility ranged from 0.8 to 2 mm in all measures. There were also no differences in the amount of hypermobility (position at rest minus position at valsalva) between groups. We found no statistically significant differences in bladder neck and urethral position or mobility on dynamic MRI evaluation between continent and incontinent men status post-radical prostatectomy. A more complex mechanism for post-prostatectomy incontinence needs to be modeled in order to better understand the continence mechanism in this select group of men. © 2013 Wiley Periodicals, Inc.

  19. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.

    Science.gov (United States)

    Elmunzer, B Joseph; Scheiman, James M; Lehman, Glen A; Chak, Amitabh; Mosler, Patrick; Higgins, Peter D R; Hayward, Rodney A; Romagnuolo, Joseph; Elta, Grace H; Sherman, Stuart; Waljee, Akbar K; Repaka, Aparna; Atkinson, Matthew R; Cote, Gregory A; Kwon, Richard S; McHenry, Lee; Piraka, Cyrus R; Wamsteker, Erik J; Watkins, James L; Korsnes, Sheryl J; Schmidt, Suzette E; Turner, Sarah M; Nicholson, Sylvia; Fogel, Evan L

    2012-04-12

    Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights. A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P=0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P=0.03). Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.).

  20. Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial.

    Science.gov (United States)

    Weaver, Lindell K; Wilson, Steffanie H; Lindblad, Anne S; Churchill, Susan; Deru, Kayla; Price, Robert C; Williams, Chris S; Orrison, William W; Walker, James M; Meehan, Anna; Mirow, Susan

    2018-01-01

    In prior military randomized trials, participants with persistent symptoms after mild traumatic brain injury (TBI) reported improvement regardless of receiving hyperbaric oxygen (HBO₂) or sham intervention. This study's objectives were to identify outcomes for future efficacy trials and describe changes by intervention. This Phase II, randomized, double-blind, sham-controlled trial enrolled military personnel with mild TBI and persistent post-concussive symptoms. Participants were randomized to receive 40 HBO₂ (1.5 atmospheres absolute (ATA), ⟩99% oxygen, 60 minutes) or sham chamber sessions (1.2 ATA, room air, 60 minutes) over 12 weeks. Participants and evaluators were blinded to allocation. Outcomes assessed at baseline, 13 weeks and six months included symptoms, quality of life, neuropsychological, neurological, electroencephalography, sleep, auditory, vestibular, autonomic, visual, neuroimaging, and laboratory testing. Participants completed 12-month questionnaires. Intention-to-treat results are reported. From 9/11/2012 to 5/19/2014, 71 randomized participants received HBO₂ (n=36) or sham (n=35). At baseline, 35 participants (49%) met post-traumatic stress disorder (PTSD) criteria. By the Neurobehavioral Symptom Inventory, the HBO₂ group had improved 13-week scores (mean change -3.6 points, P=0.03) compared to sham (+3.9 points). In participants with PTSD, change with HBO₂ was more pronounced (-8.6 vs. +4.8 points with sham, P=0.02). PTSD symptoms also improved in the HBO₂ group, and more so in the subgroup with PTSD. Improvements regressed at six and 12 months. Hyperbaric oxygen improved some cognitive processing speed and sleep measures. Participants with PTSD receiving HBO₂ had improved functional balance and reduced vestibular complaints at 13 weeks. By 13 weeks, HBO₂ improved post-concussive and PTSD symptoms, cognitive processing speed, sleep quality, and balance function, most dramatically in those with PTSD. Changes did not persist

  1. Project Rulison: post-shot plans and evaluations

    Energy Technology Data Exchange (ETDEWEB)

    1969-12-01

    Project Rulison post-shot plans and evaluations are discussed and include physical characteristics of the Rulison cavity; pressure and temperature expected in the cavity; amount, nature, and distribution of radioactivity in the cavity; reentry plan; radioactive species which may be encountered during reentry; public safety considerations arising from release of radioactivity; procedures to assure public safety; and the radiological safety plan. Maximum hypothetical accidents and ecological considerations are discussed in the appendices.

  2. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

    Science.gov (United States)

    Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

    2016-01-28

    Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

  3. Post-trial obligations - DOI: 10.3395/reciis.v2.Sup1.210en

    Directory of Open Access Journals (Sweden)

    Doris Schroeder

    2008-12-01

    Full Text Available In its essence, post-trial obligations describe a duty by research sponsors to provide a successfully tested drug to research participants who took part in the relevant clinical trials after the trial has been concluded. In some instances, this duty is extended beyond the research participants. This article is divided into three main parts. The first part outlines the legal basis for post-trial obligations by looking at international guidelines, including those issued by the World Medical Association. National legislation is exemplified through resolutions and guidelines issued by Brazil and South Africa respectively. The second part analyses the ethical foundation for post-trial obligations, in particular the attempt to minimize exploitation of research subjects. The third part raises obstacles and challenges for the implementation of post-trial obligations. The jury is still out on whether post-trial obligations in the form of access to drugs for clinical trial participants is the best, or even a good way, to avoid exploitation in medical research.

  4. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

  5. Clinical evaluation of post-extraction site wound healing.

    Science.gov (United States)

    Adeyemo, Wasiu Lanre; Ladeinde, Akinola Ladipo; Ogunlewe, Mobolanle Olugbemiga

    2006-07-01

    The aim of this prospective study was to evaluate the clinical pattern of post-extraction wound healing with a view to identify the types, incidence, and pattern of healing complications following non-surgical tooth extraction. A total of 311 patients, who were referred for non-surgical (intra-alveolar) extractions, were included in the study. The relevant pre-operative information recorded for each patient included age and gender of the patient, indications for extraction, and tooth/teeth removed. Extractions were performed under local anesthesia with dental forceps, elevators, or both. Patients were evaluated on the third and seventh postoperative days for alveolus healing assessment. Data recorded were: biodata, day of presentation for alveolus healing assessment, day of onset of any symptoms, body temperature (degrees C) in cases of alveolus infection, and presence or absence of pain. Two hundred eighty-two patients (282) with 318 extraction sites were evaluated for alveolus healing. Healing was uneventful in 283 alveoli (89%), while 35 alveoli (11%) developed healing complications. These complications were: localized osteitis 26 (8.2%); acutely infected alveolus 5 (1.6%); and an acutely inflamed alveolus 4 (1.2%). Females developed more complications than males (p=0.003). Most complications were found in molars (60%) and premolars (37.1%). Localized osteitis caused severe pain in all cases, while infected and inflamed alveolus caused mild or no pain. Thirty patients (12%) among those without healing complications experienced mild pain. Most of the post-extraction alveoli healed uneventfully. Apart from alveolar osteitis (AO), post-extraction alveolus healing was also complicated by acutely infected alveoli and acutely inflamed alveoli. This study also demonstrated a painful alveolus is not necessarily a disturbance of post-extraction site wound healing; a thorough clinical examination must, therefore, be made to exclude any of the complications.

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

    Directory of Open Access Journals (Sweden)

    Rahav Boussi-Gross

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

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

    Science.gov (United States)

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

    2013-01-01

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

  8. The PAV trial: Does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277

    Directory of Open Access Journals (Sweden)

    Hurley Susan

    2004-03-01

    Full Text Available Abstract Background Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. Methods/design A randomised placebo-controlled blinded 2 × 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18–50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496 – 124 in each factorial group is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i oral lactobacillus versus placebo and (ii vaginal lactobacillus versus placebo.

  9. Effectiveness of compression stockings to prevent the post-thrombotic syndrome (The SOX Trial and Bio-SOX biomarker substudy: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rodger Marc A

    2007-07-01

    Full Text Available Abstract Background Post thrombotic syndrome (PTS is a burdensome and costly complication of deep venous thrombosis (DVT that develops in 20–40% of patients within 1–2 years after symptomatic DVT. Affected patients have chronic leg pain and swelling and may develop ulcers. Venous valve disruption from the thrombus itself or thrombus-associated mediators of inflammation is considered to be a key initiating event for the development of venous hypertension that often underlies PTS. As existing treatments for PTS are extremely limited, strategies that focus on preventing the development of PTS in patients with DVT are more likely to be effective and cost-effective in reducing its burden. Elastic compression stockings (ECS could be helpful in preventing PTS; however, data on their effectiveness are scarce and conflicting. Methods/Design The SOX Trial is a randomized, allocation concealed, double-blind multicenter clinical trial. The objective of the study is to evaluate ECS to prevent PTS. A total of 800 patients with proximal DVT will be randomized to one of 2 treatment groups: ECS or placebo (inactive stockings worn on the DVT-affected leg daily for 2 years. The primary outcome is the incidence of PTS during follow-up. Secondary outcomes are severity of PTS, venous thromboembolism (VTE recurrence, death from VTE, quality of life and cost-effectiveness. Outcomes will be evaluated during 6 clinic visits and 2 telephone follow ups. At baseline, 1 and 6 months, blood samples will be obtained to evaluate the role of inflammatory mediators and genetic markers of thrombophilia in the development of PTS (Bio-SOX substudy. Discussion The SOX Trial will be the largest study and the first with a placebo control to evaluate the effectiveness of ECS to prevent PTS. It is designed to provide definitive data on the effects of ECS on the occurrence and severity of PTS, as well as DVT recurrence, cost-effectiveness and quality of life. This study will also

  10. Post Landsat-D advanced concept evaluation /PLACE/

    Science.gov (United States)

    Alexander, L. D.; Alvarado, U. R.; Flatow, F. S.

    1979-01-01

    The aim of the Post Landsat-D Advanced Concept Evaluation (PLACE) program was to identify the key technology requirements of earth resources satellite systems for the 1985-2000 period. The program involved four efforts: (1) examination of future needs in the earth resources area, (2) creation of a space systems technology model capable of satisfying these needs, (3) identification of key technology requirements posed by this model, and (4) development of a methodology (PRISM) to assist in the priority structuring of the resulting technologies.

  11. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.

    Science.gov (United States)

    Kanes, Stephen; Colquhoun, Helen; Gunduz-Bruce, Handan; Raines, Shane; Arnold, Ryan; Schacterle, Amy; Doherty, James; Epperson, C Neill; Deligiannidis, Kristina M; Riesenberg, Robert; Hoffmann, Ethan; Rubinow, David; Jonas, Jeffrey; Paul, Steven; Meltzer-Brody, Samantha

    2017-07-29

    Post-partum depression is a serious mood disorder in women that might be triggered by peripartum fluctuations in reproductive hormones. This phase 2 study investigated brexanolone (USAN; formerly SAGE-547 injection), an intravenous formulation of allopregnanolone, a positive allosteric modulator of γ-aminobutyric acid (GABA A ) receptors, for the treatment of post-partum depression. For this double-blind, randomised, placebo-controlled trial, we enrolled self-referred or physician-referred female inpatients (≤6 months post partum) with severe post-partum depression (Hamilton Rating Scale for Depression [HAM-D] total score ≥26) in four hospitals in the USA. Eligible women were randomly assigned (1:1), via a computer-generated randomisation program, to receive either a single, continuous intravenous dose of brexanolone or placebo for 60 h. Patients and investigators were masked to treatment assignments. The primary efficacy endpoint was the change from baseline in the 17-item HAM-D total score at 60 h, assessed in all randomised patients who started infusion of study drug or placebo and who had a completed baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Patients were followed up until day 30. This trial is registered with ClinicalTrials.gov, number NCT02614547. This trial was done between Dec 15, 2015 (first enrolment), and May 19, 2016 (final visit of the last enrolled patient). 21 women were randomly assigned to the brexanolone (n=10) and placebo (n=11) groups. At 60 h, mean reduction in HAM-D total score from baseline was 21·0 points (SE 2·9) in the brexanolone group compared with 8·8 points (SE 2·8) in the placebo group (difference -12·2, 95% CI -20·77 to -3·67; p=0·0075; effect size 1·2). No deaths, serious adverse events, or discontinuations because of adverse events were reported in either group. Four of ten patients in the brexanolone group had adverse events compared with eight of 11 in the placebo group. The most

  12. Stomach: ultrasonography evaluation and post mortem inspection in adult horses

    Directory of Open Access Journals (Sweden)

    Cristiano Chaves Pessoa da Veiga

    2014-06-01

    Full Text Available ABSTRACT. Veiga C.C.P., Cascon C.M., Souza B.G., Braga L.S.M., Souza V.C., Ferreira A.M.R. & Leite J.S. [Stomach: ultrasonography evaluation and post mortem inspection in adult horses.] Avaliação ultrassonográfica e anatomopatológica macroscópica do estômago de equinos destinados ao abate comercial. Revista Brasileira de Medicina Veterinária, 36(2:125-130, 2014. Instituto de Veterinária, Universidade Federal Rural do Rio de Janeiro, BR 465, km 7, Seropédica, 23890-000, RJ, Brasil. E-mail: radiovet@ufrrj.br The equine gastric ulcer syndrome (EGUS includes all symptomatic or asymptomatic cases of erosions, ulcers, gastritis, gastric emptying disorders, duodenitis, duodenal ulcers and complications of these disorders. Occupies a prominent place in the equine clinic where you can go for the death of the animal. Ultrasonography of the stomach is indicated when the animals showed clinical signs of gastric disease. The aim of this study was to describe the sonographic evaluation and macroscopic pathological findings of the stomach of adult horses intended for commercial slaughter. To this 39 intended for commercial slaughter horses were evaluated. Sonographic evaluation before slaughter transabdominal via the left side of abdomen for evaluation of the stomach was performed. After the slaughter of these animals their stomachs were collected, evaluated and photographed. The study concluded that ultrasonography identified the stomach in all animals evaluated, but did not allow a careful evaluation of the entire length of the viscera, especially the aglandular region and pleated border. All animals evaluated had injury to the gastric mucosa in different degrees. In animals evaluated, the stomach region was most affected by injuries glandular region, although the most severe lesions have been found in the ruffled border adjacent to aglandular region.

  13. Optimised anaesthesia to reduce post operative cognitive decline (POCD in older patients undergoing elective surgery, a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Clive Ballard

    Full Text Available BACKGROUND: The study determined the one year incidence of post operative cognitive decline (POCD and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age undergoing elective orthopaedic or abdominal surgery. METHODS AND TRIAL DESIGN: The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery. RESULTS: In the 52 week prospective cohort study (192 surgical patients and 138 controls, mild (χ(2 = 17.9 p<0.0001, moderate (χ(2 = 7.8 p = 0.005 and severe (χ(2 = 5.1 p = 0.02 POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls. In the nested RCT, 81 patients were randomized, 73 contributing to the data analysis (34 intervention, 39 control. In the intervention group mild POCD was significantly reduced at 1, 12 and 52 weeks (Fisher's Exact Test p = 0.018, χ(2 = 5.1 p = 0.02 and χ(2 = 5.9 p = 0.015, and moderate POCD was reduced at 1 and 52 weeks (χ(2 = 4.4 p = 0·037 and χ(2 = 5.4 p = 0.02. In addition there was significant improvement in reaction time at all time-points (Vigilance Reaction Time MWU Z = -2.1 p = 0.03, MWU Z = -2.7 p = 0.004, MWU Z = -3.0 p = 0.005, in MMSE at one and 52 weeks (MWU Z = -2.9 p = 0.003, MWU Z = -3.3 p = 0.001, and in executive function at 12 and 52 weeks (Trail Making MWU Z = -2.4 p = .0.018, MWU Z = -2.4 p = 0.019. CONCLUSION: POCD is common and persistent in older adults following surgery. The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral oxygenation as a pragmatic intervention to reduce post-operative cognitive impairment. TRIAL REGISTRATION

  14. WP6 - Application Integration, Trials and Evaluation

    DEFF Research Database (Denmark)

    Prasad, Neeli R.; Cetin, Bilge Kartal; Moran, Humberto

    2009-01-01

    of the Total cost of ownership (TCO) associated to RFID systems as well as to confirm the ease of implementation of ASPIRE open source software (OSS) components into current IT SME infrastructure.The different pilot trials described in this deliverable are the following: • A Logistics pilot for the packing...... industry to be setup at SENSAP S.A in Greece. • A pilot for company STAFF-Jeans SA, which focuses on two distinct yet complementary scenarios, namely logistics and retail scenarios for the apparel-textiles industry • PV Lab pilot, which is demonstration pilot that aims at showcasing the ASPIRE middleware....

  15. Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial

    DEFF Research Database (Denmark)

    Nøjgaard, Camilla; Hornum, Mads; Elkjaer, Margarita

    2009-01-01

    OBJECTIVE: Acute pancreatitis is the most dreaded complication of ERCP. Two studies have shown a significant effect of glyceryl nitrate (GN) in preventing post-ERCP pancreatitis (PEP). We wanted to evaluate this promising effect in a larger study with a realistically precalculated incidence of PEP...... (PL) was an identical-looking patch applied before ERCP. A total of 401 patients received GN; 405 received PL. RESULTS: Forty-seven patients had PEP (5.8%), 18 (4.5%) in the GN group and 29 (7.1%) in the PL group. The relative risk reduction of PEP in the GN group of 36% (95% CI, 11%-65%) compared...... (P = .006) were more common in the GN group. Significant variables predictive of PEP were not having biliary stones extracted; hypotension after ERCP; morphine, propofol, glucagon, and general anesthesia during the procedure; or no sufentanil during the procedure. CONCLUSIONS: The trial showed...

  16. Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: Post-Intervention Results

    Science.gov (United States)

    Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.

    2013-01-01

    The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852

  17. Investigating the key indicators for evaluating post-disaster shelter.

    Science.gov (United States)

    Nath, Ronita; Shannon, Harry; Kabali, Conrad; Oremus, Mark

    2017-07-01

    This study sought to identify the primary indicators for evaluating shelter assistance following natural disasters and then to develop a shelter evaluation instrument based on these indicators. Electronic databases and the 'grey' literature were scoured for publications with a relation to post-disaster shelter assistance. Indicators for evaluating such assistance were extracted from these publications. In total, 1,525 indicators were extracted from 181 publications. A preliminary evaluation instrument was designed from these 1,525 indicators. Shelter experts checked the instrument for face and content validity, and it was revised subsequently based on their input. The revised instrument comprises a version for use by shelter agencies (48 questions that assess 23 indicators) and a version for use by beneficiaries (52 questions that assess 22 indicators). The instrument can serve as a standardised tool to enable groups to gauge whether or not the shelter assistance that they supply meets the needs of disaster-affected populations. © 2017 The Author(s). Disasters © Overseas Development Institute, 2017.

  18. Evaluating the Flipped Classroom: A Randomized Controlled Trial

    Science.gov (United States)

    Wozny, Nathan; Balser, Cary; Ives, Drew

    2018-01-01

    Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

  19. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    Energy Technology Data Exchange (ETDEWEB)

    Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

    2015-11-15

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  20. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    Science.gov (United States)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  1. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    International Nuclear Information System (INIS)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

    2015-01-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  2. Global Health Diplomacy, Monitoring & Evaluation, and the Importance of Quality Assurance & Control: Findings from NIMH Project Accept (HPTN 043): A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand.

    Science.gov (United States)

    Kevany, Sebastian; Khumalo-Sakutukwa, Gertrude; Singh, Basant; Chingono, Alfred; Morin, Stephen

    2016-01-01

    Provision and scale-up of high quality, evidence-based services is essential for successful international HIV prevention interventions in order to generate and maintain intervention uptake, study integrity and participant trust, from both health service delivery and diplomatic perspectives. We developed quality assurance (QAC) procedures to evaluate staff fidelity to a cluster-randomized trial of the NIMH Project Accept (HPTN 043) assessing the effectiveness of a community-based voluntary counseling and testing strategy. The intervention was comprised of three components-Mobile Voluntary Counseling and Testing (MVCT), Community Mobilization (CM) and Post-Test Support Services (PTSS). QAC procedures were based on standardized criteria, and were designed to assess both provider skills and adherence to the intervention protocol. Supervisors observed a random sample of 5% to 10% of sessions each month and evaluated staff against multiple criteria on scales of 1-5. A score of 5 indicated 100% adherence, 4 indicated 95% adherence, and 3 indicated 90% adherence. Scores below 3 were considered unsatisfactory, and protocol deviations were discussed with the respective staff. During the first year of the intervention, the mean scores of MVCT and CM staff across the 5 study sites were 4 (95% adherence) or greater and continued to improve over time. Mean QAC scores for the PTSS component were lower and displayed greater fluctuations. Challenges to PTSS staff were identified as coping with the wide range of activities in the PTSS component and the novelty of the PTSS process. QAC fluctuations for PTSS were also associated with new staff hires or changes in staff responsibilities. Through constant staff monitoring and support, by Year 2, QAC scores for PTSS activities had reached those of MVCT and CM. The implementation of a large-sale, evidence based HIV intervention requires extensive QAC to ensure implementation effectiveness. Ongoing appraisal of study staff across sites

  3. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    Science.gov (United States)

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-10-01

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  4. Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Astrid V Fahlenkamp

    Full Text Available Like other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV. We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis.220 subjects with elevated PONV risk (Apfel score ≥2 undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up.Logistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02-5.19, p = 0.044. Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138. After xenon, nausea occurred significantly earlier (p = 0.014, was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups.In our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea.EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT00793663.

  5. Post-Exercise Protein Trial: Interactions between Diet and Exercise (PEPTIDE): study protocol for randomized controlled trial.

    Science.gov (United States)

    Alghannam, Abdullah F; Tsintzas, Kostas; Thompson, Dylan; Bilzon, James; Betts, James A

    2014-11-24

    Performing regular exercise is known to manifest a number of health benefits that mainly relate to cardiovascular and muscular adaptations to allow for greater oxygen extraction and utilization. There is increasing evidence that nutrient intake can affect the adaptive response to a single exercise bout, and that protein feeding is important to facilitate this process. Thus, the exercise-nutrient interaction may potentially lead to a greater response to training. The role of post-exercise protein ingestion in enhancing the effects of running-based endurance exercise training relative to energy-matched carbohydrate intervention remains to be established. Additionally, the influence of immediate versus overnight protein ingestion in mediating these training effects is currently unknown. The current protocol aims to establish whether post-exercise nutrient intake and timing would influence the magnitude of improvements during a prescribed endurance training program. The project involves two phases with each involving two treatment arms applied in a randomized investigator-participant double-blind parallel group design. For each treatment, participants will be required to undergo six weeks of running-based endurance training. Immediately post-exercise, participants will be prescribed solutions providing 0.4 grams per kilogram of body mass (g · kg(-1)) of whey protein hydrolysate plus 0.4 g · kg(-1) sucrose, relative to an isocaloric sucrose control (0.8 g · kg(-1); Phase I). In Phase II, identical protein supplements will be provided (0.4 + 0.4 g · kg(-1) · h(-1) of whey protein hydrolysate and sucrose, respectively), with the timing of ingestion manipulated to compare immediate versus overnight recovery feedings. Anthropometric, expired gas, venous blood and muscle biopsy samples will be obtained at baseline and following the six-week training period. By investigating the role of nutrition in enhancing the effects of endurance exercise training, we will provide

  6. A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release.

    Science.gov (United States)

    Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; O'Grady, Kevin E; Fitzgerald, Terrence T; Vocci, Frank J

    2017-03-01

    This study examined whether starting buprenorphine treatment prior to prison and after release from prison would be associated with better drug treatment outcomes and whether males and females responded differently to the combination of in-prison treatment and post-release service setting. Study design was a 2 (In-Prison Treatment: Condition: Buprenorphine Treatment: vs. Counseling Only)×2 [Post-Release Service Setting Condition: Opioid Treatment: Program (OTP) vs. Community Health Center (CHC)]×2 (Gender) factorial design. The trial was conducted between September 2008 and July 2012. Follow-up assessments were completed in 2014. Participants were recruited from two Baltimore pre-release prisons (one for men and one for women). Adult pre-release prisoners who were heroin-dependent during the year prior to incarceration were eligible. Post-release assessments were conducted at 1, 3, 6, and 12-month following prison release. Participants (N=211) in the in-prison treatment condition effect had a higher mean number of days of community buprenorphine treatment compared to the condition in which participants initiated medication after release (P=0.005). However, there were no statistically significant hypothesized effects for the in-prison treatment condition in terms of: days of heroin use and crime, and opioid and cocaine positive urine screening test results (all Ps>0.14) and no statistically significant hypothesized gender effects (all Ps>0.18). Although initiating buprenorphine treatment in prison compared to after-release was associated with more days receiving buprenorphine treatment in the designated community treatment program during the 12-months post-release assessment, it was not associated with superior outcomes in terms of heroin and cocaine use and criminal behavior. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Neuroimaging Correlates of Post-Stroke Aphasia Rehabilitation in a Pilot Randomized Trial of Constraint-Induced Aphasia Therapy.

    Science.gov (United States)

    Nenert, Rodolphe; Allendorfer, Jane B; Martin, Amber M; Banks, Christi; Ball, Angel; Vannest, Jennifer; Dietz, Aimee R; Szaflarski, Jerzy P

    2017-07-18

    BACKGROUND Recovery from post-stroke aphasia is a long and complex process with an uncertain outcome. Various interventions have been proposed to augment the recovery, including constraint-induced aphasia therapy (CIAT). CIAT has been applied to patients suffering from post-stroke aphasia in several unblinded studies to show mild-to-moderate linguistic gains. The aim of the present study was to evaluate the neuroimaging correlates of CIAT in patients with chronic aphasia related to left middle cerebral artery stroke. MATERIAL AND METHODS Out of 24 patients recruited in a pilot randomized blinded trial of CIAT, 19 patients received fMRI of language. Eleven of them received CIAT (trained) and eight served as a control group (untrained). Each patient participated in three fMRI sessions (before training, after training, and 3 months later) that included semantic decision and verb generation fMRI tasks, and a battery of language tests. Matching healthy control participants were also included (N=38; matching based on age, handedness, and sex). RESULTS Language testing showed significantly improved performance on Boston Naming Test (BNT; paphasia with no specific effect from CIAT training.

  8. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia.

    Science.gov (United States)

    Steele, Catriona M; Bayley, Mark T; Peladeau-Pigeon, Melanie; Nagy, Ahmed; Namasivayam, Ashwini M; Stokely, Shauna L; Wolkin, Talia

    2016-06-01

    The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue.

  9. Ear Acupuncture for Post-Operative Pain Associated with Ambulatory Arthroscopic Knee Surgery: A Randomized Controlled Trial

    Science.gov (United States)

    2014-01-14

    E7(/(3+21(180%(5 ,QFOXGHDUHDFRGH 14 Jan 2014 Final Report Ear acupuncture for post-operative pain associated with ambulatory arthroscopic...DISTRIBUTION A. Approved for public release: distribution unlimited. The purpose of this study is to compare ear acupuncture plus standard therapy versus...3298 Ear Acupuncture for Post-operative Pa111 Assoc1ated With Ambulatory Arthroscopic Knee Surgery A Randomized Controlled Trial ’• V ’’ ’-’ I

  10. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

    Science.gov (United States)

    Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L

    2010-08-01

    A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining

  11. Therapeutic Effect of Virtual Reality on Post-Stroke Patients: Randomized Clinical Trial.

    Science.gov (United States)

    Pedreira da Fonseca, Erika; Ribeiro da Silva, Nildo Manoel; Pinto, Elen Beatriz

    2017-01-01

    The study aimed to check the therapeutic effect of virtual reality associated with conventional physiotherapy on gait balance and the occurrence of falls after a stroke. This was a randomized, blinded clinical trial conducted with post-stroke patients, randomized into two groups-treatment group and control group-and subjected to balance assessments by the Dynamic Gait Index and investigation of falls before and after 20 intervention sessions. Statistically significant difference was considered at P < .05. We selected 30 patients, but there were three segment losses, resulting in a total of 13 patients in the control group and 14 in the treatment group. There was an improvement in gait balance and reduced occurrence of falls in both groups. After intervention, the differences in gait balance in the control group (P = .047) and the reduction in the occurrence of falls in the treatment group (P = .049) were significant. However, in intergroup analysis, there was no difference in the two outcomes. Therapy with games was a useful tool for gait balance rehabilitation in post-stroke patients, with repercussions on the reduction of falls. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  12. Comparing the effect of ketamine and benzydamine gargling with placebo on post-operative sore throat: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Seyed Hamid Reza Faiz

    2014-01-01

    Full Text Available Background: Air way intubation for general anesthesia usually leads to sore throat after surgery. Ketamine plays an important role to block a number of receptors related to pain. Benzydamine hydrochloride is a non-steroidal anti-inflammatory drug that has been used to improve oropharyngeal disorders. In this study, it was intended to compare the effect of gargling different solutions before the surgery on post-operative sore throat (POST in patients who underwent general anesthesia for hysterectomy. Materials and Methods: A total of 60 patients who underwent the elective hysterectomy were entered to the randomized controlled trial regarding to the eligibility criteria. Patients were simply randomly allocated to three groups and received one code. Every code was representative for a specific drug: 20 cc normal saline (control group or 1.5 mg benzydamine in 20 cc solution or 20 mg ketamine in 20 cc solutions. All the research teams were blinded to the received solutions. POST was evaluated with numerical rating scale. The data were entered to SPSS software and analysis of variance (ANOVA and Kruskal-Wallis one-way analysis of variance test, were performed. Results: The mean ages of ketamine, benzydamine, and normal saline recipients were not significantly different. The trend of the severity of sore throat during the first 24 h after the operation in ketamine recipients was significantly lower than the other two groups (P < 0.001. Conclusion: The pain scale after surgery was reduced by using both ketamine and benzydamine, but the ketamine effect was more noticeable.

  13. A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release.

    Science.gov (United States)

    Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; O'Grady, Kevin E

    2008-08-01

    This study examined the effectiveness of methadone maintenance initiated prior to or just after release from prison at 6 months post-release. A three-group randomized controlled trial was conducted between September 2003 and June 2005. A Baltimore pre-release prison. Two hundred and eleven adult pre-release inmates who were heroin-dependent during the year prior to incarceration. Participants were assigned randomly to the following: counseling only: counseling in prison, with passive referral to treatment upon release (n = 70); counseling + transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n = 70); and counseling + methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n = 71). Addiction Severity Index at study entry and follow-up. Additional assessments at 6 months post-release were treatment record review; urine drug testing for opioids, cocaine and other illicit drugs. Counseling + methadone participants were significantly more likely than both counseling only and counseling + transfer participants to be retained in drug abuse treatment (P = 0.0001) and significantly less likely to have an opioid-positive urine specimen compared to counseling only (P = 0.002). Furthermore, counseling + methadone participants reported significantly fewer days of involvement in self-reported heroin use and criminal activity than counseling only participants. Methadone maintenance, initiated prior to or immediately after release from prison, increases treatment entry and reduces heroin use at 6 months post-release compared to counseling only. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories.

  14. Evaluation of Kilifi epilepsy education programme: a randomized controlled trial.

    Science.gov (United States)

    Ibinda, Fredrick; Mbuba, Caroline K; Kariuki, Symon M; Chengo, Eddie; Ngugi, Anthony K; Odhiambo, Rachael; Lowe, Brett; Fegan, Greg; Carter, Julie A; Newton, Charles R

    2014-02-01

    The epilepsy treatment gap is largest in resource-poor countries. We evaluated the efficacy of a 1-day health education program in a rural area of Kenya. The primary outcome was adherence to antiepileptic drugs (AEDs) as measured by drug levels in the blood, and the secondary outcomes were seizure frequency and Kilifi Epilepsy Beliefs and Attitudes Scores (KEBAS). Seven hundred thirty-eight people with epilepsy (PWE) and their designated supporter were randomized to either the intervention (education) or nonintervention group. Data were collected at baseline and 1 year after the education intervention was administered to the intervention group. There were 581 PWE assessed at both time points. At the end of the study, 105 PWE from the intervention group and 86 from the nonintervention group gave blood samples, which were assayed for the most commonly used AEDs (phenobarbital, phenytoin, and carbamazepine). The proportions of PWE with detectable AED levels were determined using a standard blood assay method. The laboratory technicians conducting the assays were blinded to the randomization. Secondary outcomes were evaluated using questionnaires administered by trained field staff. Modified Poisson regression was used to investigate the factors associated with improved adherence (transition from nonoptimal AED level in blood at baseline to optimal levels at follow-up), reduced seizures, and improved KEBAS, which was done as a post hoc analysis. This trial is registered in ISRCTN register under ISRCTN35680481. There was no significant difference in adherence to AEDs based on detectable drug levels (odds ratio [OR] 1.46, 95% confidence interval [95% CI] 0.74-2.90, p = 0.28) or by self-reports (OR 1.00, 95% CI 0.71-1.40, p = 1.00) between the intervention and nonintervention group. The intervention group had significantly fewer beliefs about traditional causes of epilepsy, cultural treatment, and negative stereotypes than the nonintervention group. There was no

  15. Cross-system evaluation of clinical trial search engines.

    Science.gov (United States)

    Jiang, Silis Y; Weng, Chunhua

    2014-01-01

    Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.

  16. Evaluating Post-Earthquake Building Safety Using Economical MEMS Seismometers.

    Science.gov (United States)

    Hsu, Ting-Yu; Yin, Ren-Cheng; Wu, Yih-Min

    2018-05-05

    The earthquake early warning (EEW)-research group at National Taiwan University has been developing a microelectromechanical system-based accelerometer called “P-Alert”, designed for issuing EEWs. The main advantage of P-Alert is that it is a relatively economical seismometer. However, because of the expensive nature of commercial hardware for structural health monitoring (SHM) systems, the application of SHM to buildings remains limited. To determine the performance of P-Alert for evaluating post-earthquake building safety, we conducted a series of steel-frame shaking table tests with incremental damage. We used the fragility curves of different damage levels and the interstory drift ratios (calculated by the measured acceleration of each story using double integration and a filter) to gauge the potential damage levels. We concluded that the acceptable detection of damage for an entire building is possible. With improvements to the synchronization of the P-Alert sensors, we also anticipate a damage localization feature for the stories of a building.

  17. A randomised controlled trial of prophylaxis of post-abortal infection: ceftriaxone versus placebo

    DEFF Research Database (Denmark)

    Henriques, C U; Wilken-Jensen, C; Thorsen, P

    1994-01-01

    days postoperatively, underwent pelvic examination. Clinical endpoints were noted. MAIN OUTCOME MEASURES: Post-operative pelvic inflammatory disease in women applying for legal first trimester abortion. RESULTS: Seven hundred and eighty-six women fulfilled the criteria for evaluation. A tendency toward...... for legal first trimester abortion, treated peroperatively with ceftriaxone. No significant difference was demonstrated between high risk patients treated with ceftriaxone or ampicillin/pivampicillin and metronidazole. Udgivelsesdato: 1994-Jul......OBJECTIVE: To investigate the incidence of post-operative infection after first trimester abortion in women treated with a long-acting cephalosporin (ceftriaxone) compared with low risk patients receiving no treatment and with high risk patients receiving our standard treatment of ampicillin...

  18. Pharmaceutical companies vs. the State: who is responsible for post-trial provision of drugs in Brazil?

    Science.gov (United States)

    Wang, Daniel Wei L; Ferraz, Octavio Luiz Motta

    2012-01-01

    This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. © 2012 American Society of Law, Medicine & Ethics, Inc.

  19. Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Qian, Yang-Yang; Chen, Hui; Tang, Xin-Ying; Jiang, Xi; Qian, Wei; Zou, Wen-Bin; Xin, Lei; Li, Bo; Qi, Yan-Fen; Hu, Liang-Hao; Zou, Duo-Wu; Jin, Zhen-Dong; Wang, Dong; Du, Yi-Qi; Wang, Luo-Wei; Liu, Feng; Li, Zhao-Shen; Liao, Zhuan

    2017-11-02

    Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is the first-line therapy for large pancreatic duct stones. Although it is a highly effective and safe procedure for the fragmentation of pancreatic stones, it is still not complication-free. Just like endoscopic retrograde cholangiopancreatography (ERCP), pancreatitis is the most common complication. To date, nonsteroidal anti-inflammatory drugs (NSAIDs) have proven to be the only effective prophylactic medication for post-ERCP pancreatitis and the European, American and Japanese Society for Gastrointestinal Endoscopy guidelines have recommended prophylactic rectally administered indomethacin for all patients undergoing ERCP. Given the little research about effective prevention for post P-ESWL pancreatitis, we aim to determine whether rectally administered indomethacin can reduce post-ESWL-pancreatitis. The RIPEP study is a prospective, randomized, double-blinded, placebo-controlled trial. One thousand three hundred and seventy patients with chronic pancreatitis and pancreatic stones (>5 mm in diameter) treated with P-ESWL at Changhai Hospital will be randomly allocated to rectally administered indomethacin or placebo therapy before the procedure. The primary endpoint is the incidence of post-ESWL pancreatitis. Secondary endpoints include the severity of pancreatitis, occurrence rate of asymptomatic hyperamylasemia and other complications. The RIPEP trial is designed to show that rectally administered indomethacin reduces the development and severity of post-ESWL pancreatitis and benefits patients treated with P-ESWL. ClinicalTrials.gov, ID: NCT02797067 . Registered on 17 November 2016.

  20. Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan.

    Science.gov (United States)

    Delaney, Anthony; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

    2013-10-01

    The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis. In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non-pharmacologic interventions, this document outlines the principles and methods for analysing and reporting the trial results. The document is prepared prior to completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and prior to completion of the two related international studies. The statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. The data collected by the research team as specified in the study protocol, and detailed in the study case report form were reviewed. Information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation and other related therapies, and other relevant data are described with appropriate comparisons between groups. The primary, secondary and tertiary outcomes for the study are defined, with description of the planned statistical analyses. A statistical analysis plan was developed, along with a trial profile, mock-up tables and figures. A plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies, along with adverse events are described. The primary, secondary and tertiary outcomes are described along with identification of subgroups to be analysed. A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the

  1. A Smartphone App (BlueIce) for Young People Who Self-Harm: Open Phase 1 Pre-Post Trial

    Science.gov (United States)

    Porter, Joanna; Grist, Rebecca

    2018-01-01

    Background Recent years have seen a significant increase in the availability of smartphone apps for mental health problems. Despite their proliferation, few apps have been specifically developed for young people, and almost none have been subject to any form of evaluation. Objective This study aimed to undertake a preliminary evaluation of a smartphone app (BlueIce), coproduced with young people and designed to help young people manage distress and urges to self-harm. We aimed to assess the acceptability, safety, and use of BlueIce and to explore the effects on the primary outcome of self-harm and the secondary outcomes of psychological functioning. Methods We undertook an open trial where we recruited young people aged 12 to 17 years attending specialist child and adolescent mental health services (CAMHS) who were currently self-harming or had a history of self-harm. Eligible participants were assessed at baseline and then given BlueIce. They were assessed 2 weeks later (post familiarization) and again at 12 weeks (post use). A behavior-screening questionnaire (Strengths and Difficulties Questionnaire) was completed along with standardized measures of depression (Mood and Feelings Questionnaire or MFQ) and anxiety (Revised Child Anxiety and Depression Scale or RCADS), taking into account self-reports of self-harm, app helpfulness, and safety. Results All core CAMHS professional groups referred at least 1 young person. Out of 40 young people recruited, 37 (93%) elected to use BlueIce after familiarization, with 29 out of 33 (88%) wanting to keep it at the end of the study. No young person called the emergency numbers during the 12-week trial, and no one was withdrawn by his or her clinician due to increased risk of suicide. Almost three-quarters (73%) of those who had recently self-harmed reported reductions in self-harm after using BlueIce for 12 weeks. There was a statistically significant mean difference of 4.91 (t31=2.11; P=.04; 95% CI 0.17-9.64) on postuse

  2. Post-licence driver education for the prevention of road traffic crashes: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Ker, Katharine; Roberts, Ian; Collier, Timothy; Beyer, Fiona; Bunn, Frances; Frost, Chris

    2005-03-01

    The effectiveness of post-licence driver education for preventing road traffic crashes was quantified using a systematic review and meta-analyses of randomised controlled trials. Searches of appropriate electronic databases, the Internet and reference lists of relevant papers were conducted. The searches were not restricted by language or publication status. Data were pooled from 21 randomised controlled trials, including over 300,000 full licence-holding drivers of all ages. Nineteen trials reported subsequent traffic offences, with a pooled relative risk of 0.96 (95% confidence interval 0.94, 0.98). Fifteen trials reported traffic crashes with a pooled relative risk of 0.98 (0.96, 1.01). Four trials reported injury crashes with a pooled relative risk of 1.12 (0.88, 1.41). The results provide no evidence that post-licence driver education is effective in preventing road injuries or crashes. Although the results are compatible with a small reduction in the occurrence of traffic crashes, this may be due to selection biases or bias in the included trials.

  3. A new tool to evaluate postgraduate training posts: the Job Evaluation Survey Tool (JEST).

    Science.gov (United States)

    Wall, David; Goodyear, Helen; Singh, Baldev; Whitehouse, Andrew; Hughes, Elizabeth; Howes, Jonathan

    2014-10-02

    Three reports in 2013 about healthcare and patient safety in the UK, namely Berwick, Francis and Keogh have highlighted the need for junior doctors' views about their training experience to be heard. In the UK, the General Medical Council (GMC) quality assures medical training programmes and requires postgraduate deaneries to undertake quality management and monitoring of all training posts in their area. The aim of this study was to develop a simple trainee questionnaire for evaluation of postgraduate training posts based on the GMC, UK standards and to look at the reliability and validity including comparison with a well-established and internationally validated tool, the Postgraduate Hospital Educational Environment Measure (PHEEM). The Job Evaluation Survey Tool (JEST), a fifteen item job evaluation questionnaire was drawn up in 2006, piloted with Foundation doctors (2007), field tested with specialist paediatric registrars (2008) and used over a three year period (2008-11) by Foundation Doctors. Statistical analyses including descriptives, reliability, correlation and factor analysis were undertaken and JEST compared with PHEEM. The JEST had a reliability of 0.91 in the pilot study of 76 Foundation doctors, 0.88 in field testing of 173 Paediatric specialist registrars and 0.91 in three years of general use in foundation training with 3367 doctors completing JEST. Correlation of JEST with PHEEM was 0.80 (p training posts.

  4. Protocol for a scoping review of post-trial extensions of randomised controlled trials using individually linked administrative and registry data.

    Science.gov (United States)

    Fitzpatrick, Tiffany; Perrier, Laure; Tricco, Andrea C; Straus, Sharon E; Jüni, Peter; Zwarenstein, Merrick; Lix, Lisa M; Smith, Mark; Rosella, Laura C; Henry, David A

    2017-02-17

    Well-conducted randomised controlled trials (RCTs) provide the least biased estimates of intervention effects. However, RCTs are costly and time-consuming to perform and long-term follow-up of participants may be hampered by lost contacts and financial constraints. Advances in computing and population-based registries have created new possibilities for increasing the value of RCTs by post-trial extension using linkage to routinely collected administrative/registry data in order to determine long-term interventional effects. There have been recent important examples, including 20+ years follow-up studies of trials of pravastatin and mammography. Despite the potential value of post-trial extension, there has been no systematic study of this literature. This scoping review aims to characterise published post-trial extension studies, assess their value, and identify any potential challenges associated with this approach. This review will use the recommended methods for scoping reviews. We will search MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. A draft search strategy is included in this protocol. Review of titles and abstracts, full texts of potentially eligible studies and data/information extraction will be conducted independently by pairs of investigators. Eligible studies will be RCTs that investigated healthcare interventions that were extended by individual linkage to administrative/registry/electronic medical records data after the completion of the planned follow-up period. Information concerning the original trial, characteristics of the extension study, any clinical, policy or ethical implications and methodological or practical challenges will be collected using standardised forms. As this study uses secondary data, and does not include person-level data, ethics approval is not required. We aim to disseminate these findings through journals and conferences targeting triallists and researchers involved in health data linkage. We

  5. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.

    Science.gov (United States)

    Krupp, L B; Hyman, L G; Grimson, R; Coyle, P K; Melville, P; Ahnn, S; Dattwyler, R; Chandler, B

    2003-06-24

    To determine whether post Lyme syndrome (PLS) is antibiotic responsive. The authors conducted a single-center randomized double-masked placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive function (mental speed), defined by a change of 25% or more on a test of reaction time. The primary laboratory outcome was an experimental measure of CSF infection, outer surface protein A (OspA). Outcome data were collected at the 6-month visit. Patients assigned to ceftriaxone showed improvement in disabling fatigue compared to the placebo group (rate ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001). No beneficial treatment effect was observed for cognitive function or the laboratory measure of persistent infection. Four patients, three of whom were on placebo, had adverse events associated with treatment, which required hospitalization. Ceftriaxone therapy in patients with PLS with severe fatigue was associated with an improvement in fatigue but not with cognitive function or an experimental laboratory measure of infection in this study. Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.

  6. Evaluation of post-vaccination immunity to canine distemper and ...

    African Journals Online (AJOL)

    SERVER

    2007-08-20

    Aug 20, 2007 ... Key words: Immunoblot ELISA, post-vaccination immunity, canine distemper, parvoviruses. INTRODUCTION. Canine ..... NGOs and other government agencies to fund and intensify ... Vaccination Programs for Dogs. In: recent ...

  7. Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans.

    Science.gov (United States)

    Raskind, Murray A; Peskind, Elaine R; Chow, Bruce; Harris, Crystal; Davis-Karim, Anne; Holmes, Hollie A; Hart, Kimberly L; McFall, Miles; Mellman, Thomas A; Reist, Christopher; Romesser, Jennifer; Rosenheck, Robert; Shih, Mei-Chiung; Stein, Murray B; Swift, Robert; Gleason, Theresa; Lu, Ying; Huang, Grant D

    2018-02-08

    In randomized trials, prazosin, an α 1 -adrenoreceptor antagonist, has been effective in alleviating nightmares associated with post-traumatic stress disorder (PTSD) in military veterans. We recruited veterans from 13 Department of Veterans Affairs medical centers who had chronic PTSD and reported frequent nightmares. Participants were randomly assigned to receive prazosin or placebo for 26 weeks; the drug or placebo was administered in escalating divided doses over the course of 5 weeks to a daily maximum of 20 mg in men and 12 mg in women. After week 10, participants continued to receive prazosin or placebo in a double-blind fashion for an additional 16 weeks. The three primary outcome measures were the change in score from baseline to 10 weeks on the Clinician-Administered PTSD Scale (CAPS) item B2 ("recurrent distressing dreams"; scores range from 0 to 8, with higher scores indicating more frequent and more distressing dreams); the change in score from baseline to 10 weeks on the Pittsburgh Sleep Quality Index (PSQI; scores range from 0 to 21, with higher scores indicating worse sleep quality); and the Clinical Global Impression of Change (CGIC) score at 10 weeks (scores range from 1 to 7, with lower scores indicating greater improvement and a score of 4 indicating no change). A total of 304 participants underwent randomization; 152 were assigned to prazosin, and 152 to placebo. At 10 weeks, there were no significant differences between the prazosin group and the placebo group in the mean change from baseline in the CAPS item B2 score (between-group difference, 0.2; 95% confidence interval [CI], -0.3 to 0.8; P=0.38), in the mean change in PSQI score (between-group difference, 0.1; 95% CI, -0.9 to 1.1; P=0.80), or in the CGIC score (between-group difference, 0; 95% CI, -0.3 to 0.3; P=0.96). There were no significant differences in these measures at 26 weeks (a secondary outcome) or in other secondary outcomes. At 10 weeks, the mean difference between the

  8. The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe.

    Science.gov (United States)

    Tarr, Robert; Hsu, Dan; Kulcsar, Zsolt; Bonvin, Christophe; Rufenacht, Daniel; Alfke, Karsten; Stingele, Robert; Jansen, Olav; Frei, Donald; Bellon, Richard; Madison, Michael; Struffert, Tobias; Dorfler, Arnd; Grunwald, Iris Q; Reith, Wolfgang; Haass, Anton

    2010-12-01

    The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

  9. Post-mortem CT evaluation of atlanto-occipital dissociation.

    Science.gov (United States)

    Madadin, Mohammed; Samaranayake, Ravindra Priyalal; O'Donnell, Chris; Cordner, Stephen

    2017-02-01

    Atlanto-occipital dissociation injury is an important injury in forensic pathology practice. Radiological diagnosis of atlanto-occipital dissociation clinically is assessed by direct measurement of occipito-vertebral skeletal relationships. Different measurements may be used to diagnose atlanto-occipital dissociation, including the basion-dens interval (BDI) and basion-axial interval (BAI). It is not known whether the normal ante-mortem measurements of BDI and BAI described in the literature are applicable to post-mortem CT images of the occipito-cervical junction (OCJ) or whether these measurements could be affected by early post-mortem changes. This study aims to compare post-mortem BDI and BAI measurements with ante-mortem values. Post-mortem CT scans of the cervical spines of 100 deceased adults were reviewed, and the BDI and BAI were measured. Different parameters were recorded in each case. The results from this study suggest that there are no effects of post-mortem changes on the measurement of BAI as relied upon clinically. There appear to be some effects of fully established rigor mortis on BDI measurement, shortening it. This may have consequences for the post mortem diagnosis of atlanto-occipital dissociation. Copyright © 2016 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  10. Combined Interval Training and Post-exercise Nutrition in Type 2 Diabetes: A Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Monique E. Francois

    2017-07-01

    Full Text Available Background: High-intensity interval training (HIIT can improve several aspects of cardiometabolic health. Previous studies have suggested that adaptations to exercise training can be augmented with post-exercise milk or protein consumption, but whether this nutritional strategy can impact the cardiometabolic adaptations to HIIT in type 2 diabetes is unknown.Objective: To determine if the addition of a post-exercise milk or protein beverage to a high-intensity interval training (HIIT intervention improves cardiometabolic health in individuals with type 2 diabetes.Design: In a proof-of-concept, double-blind clinical trial 53 adults with uncomplicated type 2 diabetes were randomized to one of three nutritional beverages (500 mL skim-milk, macronutrient control, or flavored water placebo consumed after exercise (3 days/week during a 12 week low-volume HIIT intervention. HIIT involved 10 X 1-min high-intensity intervals separated by 1-min low-intensity recovery periods. Two sessions per week were cardio-based (at ~90% of heart rate max and one session involved resistance-based exercises (at RPE of 5–6; CR-10 scale in the same interval pattern. Continuous glucose monitoring (CGM, glycosylated hemoglobin (HbA1c, body composition (dual-energy X-ray absorptiometry, cardiorespiratory fitness (V˙O2peak, blood pressure, and endothelial function (%FMD were measured before and after the intervention.Results: There were significant main effects of time (all p < 0.05 but no difference between groups (Interaction: all p > 0.71 for CGM 24-h mean glucose (−0.5 ± 1.1 mmol/L, HbA1c (−0.2 ± 0.4%, percent body fat (−0.8 ± 1.6%, and lean mass (+1.1 ± 2.8 kg. Similarly, V˙O2peak (+2.5 ± 1.6 mL/kg/min and %FMD (+1.4 ± 1.9% were increased, and mean arterial blood pressure reduced (−6 ± 7 mmHg, after 12 weeks of HIIT (all p < 0.01 with no difference between beverage groups (Interaction: all p > 0.11.Conclusion: High-intensity interval training is a

  11. Combined Interval Training and Post-exercise Nutrition in Type 2 Diabetes: A Randomized Control Trial.

    Science.gov (United States)

    Francois, Monique E; Durrer, Cody; Pistawka, Kevin J; Halperin, Frank A; Chang, Courtney; Little, Jonathan P

    2017-01-01

    Background: High-intensity interval training (HIIT) can improve several aspects of cardiometabolic health. Previous studies have suggested that adaptations to exercise training can be augmented with post-exercise milk or protein consumption, but whether this nutritional strategy can impact the cardiometabolic adaptations to HIIT in type 2 diabetes is unknown. Objective: To determine if the addition of a post-exercise milk or protein beverage to a high-intensity interval training (HIIT) intervention improves cardiometabolic health in individuals with type 2 diabetes. Design: In a proof-of-concept, double-blind clinical trial 53 adults with uncomplicated type 2 diabetes were randomized to one of three nutritional beverages (500 mL skim-milk, macronutrient control, or flavored water placebo) consumed after exercise (3 days/week) during a 12 week low-volume HIIT intervention. HIIT involved 10 X 1-min high-intensity intervals separated by 1-min low-intensity recovery periods. Two sessions per week were cardio-based (at ~90% of heart rate max) and one session involved resistance-based exercises (at RPE of 5-6; CR-10 scale) in the same interval pattern. Continuous glucose monitoring (CGM), glycosylated hemoglobin (HbA 1c ), body composition (dual-energy X-ray absorptiometry), cardiorespiratory fitness ([Formula: see text]), blood pressure, and endothelial function (%FMD) were measured before and after the intervention. Results: There were significant main effects of time (all p 0.71) for CGM 24-h mean glucose (-0.5 ± 1.1 mmol/L), HbA 1c (-0.2 ± 0.4%), percent body fat (-0.8 ± 1.6%), and lean mass (+1.1 ± 2.8 kg). Similarly, [Formula: see text] (+2.5 ± 1.6 mL/kg/min) and %FMD (+1.4 ± 1.9%) were increased, and mean arterial blood pressure reduced (-6 ± 7 mmHg), after 12 weeks of HIIT (all p 0.11). Conclusion: High-intensity interval training is a potent stimulus for improving several important metabolic and cardiovascular risk factors in type 2 diabetes. The benefits

  12. The post-arthro-CT of the wrist: clinical evaluation

    International Nuclear Information System (INIS)

    Scheurecker, G.

    2001-03-01

    To compare the diagnostic effectiveness of post-arthro-CT (PACT) and 3-compartment wrist arthrography (AG) both separate and combined versus wrist arthroscopy for scapho-lunate ligament (SLL), luno-triquetral ligament (LTL) and triangular fibrocartilage (TFC) defects and chondromalacia of the carpal bones. Material and methods: In 58 patients (16-69 years) the affected wrist was examined initially by conventional 3-compartment wrist arthrography with digital subtraction technique during injection followed by digital stress images. Afterwards spiral arthro-CT was performed in the semi-coronal and axial plane with 1 mm slice thickness and secondary true-coronal and sagittal reconstructions. Within 1 month arthroscopy was performed in general anesthesia utilizing standard joint entry points combined with routine digital picture archiving. All examinations were evaluated for SLL, LTL and TFC defects, PACT and AS for ChM too. Results: AG versus AS: The following detection rates were observed (AG and AS positive/AG negative - AS positive/AG positive - AS negative/ AG and AS negative): SLL: 16/8/0/34, LTL: 13/4/8/33, TFC: 28/5/1/24. Using AS as the 'gold standard' this translates into following sensitivity (%) and specificity (%) values: SLL 67/100, LTL 76/80, TFC 85/96. PACT versus AS: The following detection rates were observed (PACT and AS positive/PACT negative - AS positive/PACT positive - AS negative/ PACT and AS negative): SLL: 18/6/0/34, LTL: 15/2/8/33, TFC: 31/2/2/23, ChM: 20/15/3/20. Using AS as the 'gold standard' this translates into following sensitivity (%) and specificity (%) values: SLL 75/100, LTL 88/80, TFC 94/92, ChM 57/87. AG+PACT versus AS: The following detection rates were observed (AG+PACT and AS positive/AG+PACT negative - AS positive/AG+PACT positive - AS negative/ AG+PACT and AS negative): SLL: 19/5/0/34, LTL: 15/2/8/33, TFC: 31/2/2/23, ChM 20/15/3/20. Using AS as the 'gold standard' this translates into following sensitivity (%) and specificity

  13. The post-arthro-CT of the wrist: clinical evaluation

    International Nuclear Information System (INIS)

    Scheurecker, G.

    2001-03-01

    To compare the diagnostic effectiveness of post-arthro-CT (PACT) and 3-compartment wrist arthrography (AG) both separate and combined versus wrist arthroscopy for scapho-lunate ligament (SLL), luno-triquetral ligament (LTL) and triangular fibrocartilage (TFC) defects and chondromalacia of the carpal bones. Material and methods: in 58 patients (16-69 years) the affected wrist was examined initially by conventional 3-compartment wrist arthrography with digital subtraction technique during injection followed by digital stress images. Afterwards spiral arthro-CT was performed in the semi-coronal and axial plane with 1 mm slice thickness and secondary true-coronal and sagittal reconstructions. Within 1 month arthroscopy was performed in general anesthesia utilizing standard joint entry points combined with routine digital picture archiving. All examinations were evaluated for SLL, LTL and TFC defects, PACT and AS for ChM too. Results: AG versus AS: the following detection rates were observed (AG and AS positive/AG negative - AS positive/AG positive - AS negative/ AG and AS negative): SLL: 16/8/0/34, LTL: 13/4/8/33, TFC: 28/5/1/24. Using AS as the 'gold standard' this translates into following sensitivity (%) and specificity (%) values: SLL 67/100, LTL 76/80, TFC 85/96. PACT versus AS: the following detection rates were observed (PACT and AS positive/PACT negative - AS positive/PACT positive - AS negative/ PACT and AS negative): SLL: 18/6/0/34, LTL: 15/2/8/33, TFC: 31/2/2/23, ChM: 20/15/3/20. Using AS as the 'gold standard' this translates into following sensitivity (%) and specificity (%) values: SLL 75/100, LTL 88/80, TFC 94/92, ChM 57/87. AG+PACT versus AS: the following detection rates were observed (AG+PACT and AS positive/AG+PACT negative - AS positive/AG+PACT positive - AS negative/ AG+PACT and AS negative): SLL: 19/5/0/34, LTL: 15/2/8/33, TFC: 31/2/2/23, ChM 20/15/3/20. Using AS as the 'gold standard' this translates into following sensitivity (%) and specificity

  14. Evaluation of Salivary Flow Rate, pH and Buffer in Pre, Post & Post Menopausal Women on HRT.

    Science.gov (United States)

    D R, Mahesh; G, Komali; K, Jayanthi; D, Dinesh; T V, Saikavitha; Dinesh, Preeti

    2014-02-01

    Climateric is considered to be a natural phase of life which by definition is the period of life starting from decline in ovarian activity until after the end of ovarian function. It is accompanied by various health consequences that include the changes in saliva too. This study was carried out to evaluate the salivary flow rate, pH, buffering capacity in pre-menopausal, post-menopausal and post-menopausal women on HRT. (1) To evaluate the salivary flow rate, pH of resting saliva and stimulated saliva and buffer capacity of stimulated saliva in pre-menopausal, post-menopausal and post-menopausal women on Hormone Replacement Therapy (HRT). (2) To compare the above salivary findings between pre-menopausal, post-menopausal and post-menopausal women on HRT. The study was carried out on 60 patients. These patients were divided into three groups of 20 patients: Group 1: Pre-menopausal women (control), Group 2: post-menopausal women (case), Group 3: post-menopausal women on HRT (case). The control group consisted of 20 women volunteers, having regular ovulatory menstrual cycles with no known systemic illness and deleterious habits and Group 2 consists of 20 post-menopausal women and Group 3 will consist of 20 post-menopausal women on HRT. After clearing the mouth by swallowing, stimulated saliva was collected after chewing paraffin for 10 mins in to a glass centrifuge tube graded in 0.1 mL increments up to 10mL.in rare cases the collection time will be reduced or extended (5-15 min), salivary flow rate will be determined as ml/min, immediately after collection, pH was determined by dipping pH test paper directly into the sample of oral fluid, salivary buffer capacity was determined by using saliva check buffer kit (GC corporation). The data obtained was statistically evaluated using chi-square test, fisher exact test ANOVA analysis. In our study we found salivary flow rate significantly lower in the post-menopausal women in comparison with the menstruating women and also

  15. The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA: the Restore4Stroke-PSDA trial

    Directory of Open Access Journals (Sweden)

    Kootker Joyce A

    2012-07-01

    Full Text Available Abstract Background Post-Stroke Depression with or without Anxiety (PSDA is a common disorder in the chronic phase of stroke. Neuropsychiatric problems, such as PSDA, have a negative impact on social reintegration and quality of life. Currently, there is no evidence-based treatment available for reducing PSDA symptoms. In the recent literature on depression in the general population it has been shown that depression complaints can diminish by cognitive behavioural therapy (CBT. In the current study, the effectiveness of augmented, activation-based and individually tailored CBT on the reduction of depression and anxiety will be investigated in patients with PSDA. Additionally, the effects on various secondary outcome measures, such as quality of life, goal attainment and societal participation will be evaluated. This study is embedded in a consortium of 4 interrelated studies on quality of life after stroke (Restore4Stroke. Methods/design A multi-centre, assessor-blind, randomized controlled trial is conducted. A sample of 106 PSDA patients, as assessed with the Hospital Anxiety and Depression Scale (HADS depression subscale >7, will be recruited and randomly allocated to either an experimental or a control group. The experimental intervention consists of an augmented CBT intervention. The intervention is based on CBT principles of recognizing, registering, and altering negative thoughts and cognitions so that mood, and emotional symptoms are improved. CBT is augmented with direct in-vivo activation offered by occupational or movement therapists. Patients in the control group will receive a computerized cognitive training intervention. Outcomes will be assessed at baseline, immediately post intervention, and at 6 and 12 months follow up. Discussion This study is the first randomized clinical trial that evaluates the (maintenance of effects of augmented CBT on post-stroke depression with or without anxiety symptoms. Together with three other

  16. Effectiveness evaluation of whole-body electromyostimulation as a post-exercise recovery method.

    Science.gov (United States)

    DE LA Camara, Miguel A; Pardos, Ana I; Veiga, Óscar L

    2018-01-04

    Whole-body electromyostimulation (WB-EMS) devices are now being used in health and sports training, although there are few studies investigating their benefits. The objective of this research was to evaluate the effectiveness of WB-EMS as a post-exercise recovery method, and compare it with other methods like active and passive recovery. The study included nine trained men (age = 21 ± 1years, height = 1.77 ± 0.4 m, mass = 62 ± 7 kg). Three trials were performed in three different sessions, 1 week apart. Each trial, the participants completed the same exercise protocol and a different recovery method each time. A repeated measures design was used to check the basal reestablishing on several physiological variables [lactate, heart rate, percentage of tissue hemoglobin saturation, temperature, and neuromuscular fatigue] and to evaluate the quality of recovery. The non-parametric Wilcoxon and Friedman ANOVA tests were used to examine the differences between recovery methods. The results showed no differences between methods in the physiological and psychological variables analyzed. Although, the blood lactate concentration showed borderline statistical significance between methods (P = 0.050). Likewise, WB-EMS failed to recover baseline blood lactate concentration (P = 0.021) and percentage of tissue hemoglobin saturation (P = 0.023), in contrast to the other two methods. These findings suggest that WB-EMS is not a good recovery method because the power of reestablishing of several physiological and psychological parameters is not superior to other recovery methods like active and passive recovery.

  17. Evaluating prestressing strands and post-tensioning cables in concrete structures using nondestructive methods.

    Science.gov (United States)

    2015-11-01

    The objectives were to evaluate the ability of different NDE methods to detect and quantify : defects associated with corrosion of steel reinforcement and grout defects in post-tensioning : applications; and to evaluate the effectiveness of selected ...

  18. A randomized controlled trial of brief Somatic Experiencing for chronic low back pain and comorbid post-traumatic stress disorder symptoms

    DEFF Research Database (Denmark)

    Andersen, Tonny Elmose; Lahav, Yael; Ellegaard, Hanne

    2017-01-01

    Background: It is well documented that comorbid post-traumatic stress disorder (PTSD) in chronic pain is associated with a more severe symptom profile with respect to pain, disability and psychological distress. However, very few intervention studies exist targeting both PTSD and pain. The current...... study is the first randomized controlled trial evaluating the effect of the body-oriented trauma approach of Somatic Experiencing (SE) for comorbid PTSD and low back pain. Although the method is well recognized by clinicians and widely used, SE still needs to be tested in a randomized clinical trial...... in comparison with an active control group. Objective: The aim of the current study was to compare the effect of an SE intervention in addition to treatment-as-usual (TAU) for patients with chronic low back pain and comorbid PTSD compared to TAU alone. Method: The study was a two-group randomized controlled...

  19. Evaluation of the physicians‘ of n hospital opinion on clinical trials of medicinal products

    OpenAIRE

    Videikaitė, Lina

    2014-01-01

    Aim of the research. To evaluate the physicians‘ of N Hospital opinion on clinical trials of medicinal products. Objectives. To evaluate the factors affecting physicians' motivation to perform clinical trials of medicinal products as well as those that prevent the physicians getting involved in the trials. To assess physicians' attitude towards clinical trials of medicinal products. To compare the opinions of physicians who have and have’nt participated in clinical trials. Methods of...

  20. Post Occupancy Evaluation of 23 Newly Renovated Apartments in Copenhagen

    DEFF Research Database (Denmark)

    Iqbal, Ahsan; Afshari, Alireza

    2016-01-01

    The present article is based on the post occupancy occupants’ perception of indoor air quality of recently renovated 23 residential apartments in Copenhagen. The apartments are equipped with novel mechanical ventilation systems. The apartments can be categorised in four, according to the design o...

  1. Community Post-Tornado Support Groups: Intervention and Evaluation.

    Science.gov (United States)

    McCammon, Susan; And Others

    Post-tornado support groups were organized by the Greene County, North Carolina disaster coordinators and the Pitt County outreach workers from the Community Mental Health Center sponsored tornado follow-up project. The most significant intervention used was the emphasis on creating a climate of group support by establishing a forum for…

  2. Evaluation of Post-Operative Antibiotic Administration on Phenotypic ...

    African Journals Online (AJOL)

    But baseline data to judge effects of long-term post-operative antibiotic administration in clinical and surgical canine health conditions are currently lacking in Nigeria. This study aimed at providing vital baseline antibiotic profiles of canine bacteria of veterinary and public health importance. Phenotypic antibiotic susceptibility ...

  3. Applied Gamification: Reframing Evaluation in Post-Secondary Classrooms

    Science.gov (United States)

    Kulpa, Anastasia

    2017-01-01

    This piece reports on an early attempt at gamification (reframing post-secondary classrooms drawing on the structure of games). The attempt began in the 2011-2012 academic year and is structured to allow students substantial autonomy in determining which assignments, and how many of them, to complete over the course of the semester. Initial…

  4. Twelve month follow-up on a randomised controlled trial of relaxation training for post-stroke anxiety.

    Science.gov (United States)

    Golding, Katherine; Fife-Schaw, Chris; Kneebone, Ian

    2017-09-01

    To follow up participants in a randomised controlled trial of relaxation training for anxiety after stroke at 12 months. Twelve month follow-up to a randomised controlled trial, in which the control group also received treatment. Community. Fifteen of twenty one original participants with post-stroke anxiety participated in a one year follow-up study. A self-help autogenic relaxation CD listened to five times a week for one month, immediately in the intervention group and after three months in the control group. Hospital Anxiety and Depression Scale-Anxiety subscale and the Telephone Interview of Cognitive Status for inclusion. Hospital Anxiety and Depression Scale-Anxiety subscale for outcome. All measures were administered by phone. Anxiety ratings reduced significantly between pre and post-intervention, and between pre-intervention and one year follow-up ( χ 2 (2) = 22.29, p autogenic relaxation CD appear to be maintained after one year.

  5. Defendant's or convict's competency to stand trial - forensic psychiatric evaluation.

    Science.gov (United States)

    Cynkier, Przemysław N

    2017-01-01

    The purpose of this paper was to draw attention to particularly important aspects of pronouncing forensic psychiatric judgment regarding the accused or convicted individuals' competency to stand trial. The level of a person's mental capacity should be established using a structured psychiatric interview concerning a variety of aspects of a trial. Emphasis should be placed on evaluating the defendant's consciousness of the charges, knowledge of the potential punishment, ability to make significant decisions and be engaged in defense, knowledge about the role that particular people present in the courtroom play, understanding of the meaning of the evidence gathered in the case, the risk of aggression. The analysis should take into account the specificity of the mental disorder, the influence of proceedings on the course of disorder, as well as the presence of reactive disorders. Using testing tools by the expert can facilitate the process of evaluation to a certain degree. Forensic psychiatric evaluations can give rise to difficulties for the experts, what with the changing legal regulations and their interpretations. It would be justified to develop the standards of evaluation in this kind of cases, which would on the one hand apply to experts but which would also be respected by the judicial organ.

  6. Ex-post evaluations of demand forecast accuracy

    DEFF Research Database (Denmark)

    Nicolaisen, Morten Skou; Driscoll, Patrick Arthur

    2014-01-01

    Travel demand forecasts play a crucial role in the preparation of decision support to policy makers in the field of transport planning. The results feed directly into impact appraisals such as cost benefit analyses and environmental impact assessments, which are mandatory for large public works...... projects in many countries. Over the last couple of decades there has been an increasing attention to the lack of demand forecast accuracy, but since data availability for comprehensive ex- post appraisals is problematic, such studies are still relatively rare. The present paper presents a review...... of the largest ex-post studies of demand forecast accuracy for transport infrastructure projects. The focus is twofold; to provide an overview of observed levels of demand forecast inaccuracy and to explore the primary explanations offered for the observed inaccuracy. Inaccuracy in the form of both bias...

  7. Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Smeets, Xavier J N M; da Costa, David W; Fockens, Paul; Mulder, Chris J J; Timmer, Robin; Kievit, Wietske; Zegers, Marieke; Bruno, Marco J; Besselink, Marc G H; Vleggaar, Frank P; van der Hulst, Rene W M; Poen, Alexander C; Heine, Gerbrand D N; Venneman, Niels G; Kolkman, Jeroen J; Baak, Lubbertus C; Römkens, Tessa E H; van Dijk, Sven M; Hallensleben, Nora D L; van de Vrie, Wim; Seerden, Tom C J; Tan, Adriaan C I T L; Voorburg, Annet M C J; Poley, Jan-Werner; Witteman, Ben J; Bhalla, Abha; Hadithi, Muhammed; Thijs, Willem J; Schwartz, Matthijs P; Vrolijk, Jan Maarten; Verdonk, Robert C; van Delft, Foke; Keulemans, Yolande; van Goor, Harry; Drenth, Joost P H; van Geenen, Erwin J M

    2018-04-02

    Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs. EudraCT: 2015-000829-37 . Registered on 18 February 2015. 13659155 . Registered on 18 May 2015.

  8. Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population.

    Science.gov (United States)

    Darbyshire, Julie Lorraine; Price, Hermione Clare

    2012-01-01

    To identify the most appropriate format for results dissemination to maximise understanding of trial results. Qualitative. Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. All participants from these centres were eligible. All 343 participants were sent questionnaires. The low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

  9. A randomised controlled trial evaluating family mediated exercise (FAME therapy following stroke

    Directory of Open Access Journals (Sweden)

    Stokes Emma

    2008-06-01

    Full Text Available Abstract Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744

  10. How long-lasting is the post-conflict slowing after incongruent trials? Evidence from the Stroop, Simon, and flanker tasks.

    Science.gov (United States)

    Rey-Mermet, Alodie; Meier, Beat

    2017-10-01

    The purpose of the present study was to determine how long-lasting the post-conflict slowing following incongruent stimuli is. In previous research, incongruent stimuli have been used to induce a conflict because they have relevant features for two different response alternatives. So far, the post-conflict slowing following incongruent stimuli has mainly been assessed up to one trial. In the first two experiments, we assessed the persistence of the post-conflict slowing across several trials. To this end, we presented a few incongruent stimuli among non-conflict stimuli. The results showed a consistent slowing for the first few trials immediately following the incongruent trials. In addition, a sporadic slowing was still found on later trials. In two subsequent experiments, we investigated to what extent the infrequency of incongruent trials - rather than their conflict - induced this slowing. To determine this, we used the same design as in the first two experiments, but we presented non-conflict stimuli as infrequent stimuli. The results showed a slowing on one subsequent trial, ruling out the possibility that the post-conflict slowing following incongruent trials was only caused by infrequency. Together, the findings of the present study indicate that the conflict induced by incongruent trials can have a longer lasting impact on subsequent trials than previously thought.

  11. Post-cholecystectomy alkaline reactive gastritis: a randomized trial comparing sucralfate versus rabeprazole or no treatment.

    Science.gov (United States)

    Santarelli, Luca; Gabrielli, Maurizio; Candelli, Marcello; Cremonini, Filippo; Nista, Enrico C; Cammarota, Giovanni; Gasbarrini, Giovanni; Gasbarrini, Antonio

    2003-09-01

    At present there are no well-established pharmacological approaches in the management of post-cholecystectomy alkaline reactive gastritis. The aim of this study was to assess the effect of sucralfate versus rabeprazole or no treatment on dyspeptic symptoms and endoscopic/histological signs in a population of patients with a history of cholecystectomy and evidence of alkaline reactive gastritis. Sixty dyspeptic patients fulfilling the following criteria of inclusion took part in this study: (1) a history of cholecystectomy; (2) no use of anti-inflammatory steroidal and non-steroidal drugs, or abuse of alcohol; (3) evidence of abundant gastric bile reflux at endoscopy; (4) endoscopic signs of chronic gastritis; (5) histological signs of chronic gastritis; and (6) absence of Helicobacter pylori infection. Dyspeptic symptoms were evaluated by means of a self-administered validated questionnaire. Patients included in the study were randomly assigned to one of three treatment groups for 3 months: sucralfate, rabeprazole, observation. Patients were re-evaluated at the end of the treatment. Sucralfate and rabeprazole therapies were both able to significantly reduce epigastric pain, heartburn, bloating and halitosis. Endoscopic/histological signs were lower in both treatment groups compared to the observation group. Both sucralfate and rabeprazole therapies are effective treatment options in the patients with alkaline gastritis when compared with observation.

  12. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  13. Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Rand, Debbie; Zeilig, Gabi; Kizony, Rachel

    2015-06-18

    Impaired dexterity of the weaker upper extremity is common post stroke and it is recommended that these individuals practice many repetitions of movement to regain function. However, stroke rehabilitation methods do not achieve the required intensity to be effective. Touchscreen tablet technology may be used as a motivating tool for self-training impaired dexterity of the weaker upper extremity post stroke. Rehab-let is a self-training protocol utilizing game apps on a touchscreen for practicing movement of the weaker upper extremity. We will conduct a pilot randomized controlled trial to assess Rehab-let compared to traditional self-training to improve dexterity of the weaker hand, and to increase self-training time and satisfaction in individuals with subacute stroke. Forty individuals with stroke undergoing subacute rehabilitation will be randomly allocated to Rehab-let or a traditional self-training program using therapeutic aids such as balls, blocks and pegs. All participants will be requested to perform self-training for 60 minutes a day, 5 times a week for 4 weeks. Dexterity assessed by The Nine Hole Peg Test is the main outcome measure. Assessments will be administered pre and post the self-training intervention by assessors blind to the group allocation. The outcomes of this study will inform the design of a fully powered randomized controlled trial to evaluate the effectiveness of Rehab-let. If found to be effective, Rehab-let can be used during subacute rehabilitation to increase treatment intensity and improve dexterity. Potentially, Rehab-let can also be used after discharge and might be ideal for individuals with mild stroke who are often not referred to formal rehabilitation. Current Controlled Trials NCT02136433 registered on 17 September 2014.

  14. [Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

    2011-10-01

    In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

  15. Post-deployment usability evaluation of a radiology workstation

    NARCIS (Netherlands)

    Jorritsma, Wiard; Cnossen, Fokie; Dierckx, Rudi; Oudkerk, Matthijs; van Ooijen, Peter

    2015-01-01

    Objective To evaluate the usability of a radiology workstation after deployment in a hospital. Significance In radiology, it is difficult to perform valid pre-deployment usability evaluations due to the heterogeneity of the user group, the complexity of the radiological workflow, and the complexity

  16. Constraint-Induced Aphasia Therapy for Treatment of Chronic Post-Stroke Aphasia: A Randomized, Blinded, Controlled Pilot Trial.

    Science.gov (United States)

    Szaflarski, Jerzy P; Ball, Angel L; Vannest, Jennifer; Dietz, Aimee R; Allendorfer, Jane B; Martin, Amber N; Hart, Kimberly; Lindsell, Christopher J

    2015-09-24

    To provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to plan an appropriately powered randomized controlled trial (RCT). We conducted a pilot single-blinded RCT. 24 patients were randomized: 14 to CIAT and 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours or therapy). Outcomes were assessed within 1 week of intervention and at 1 and 12 weeks after intervention and included several linguistic measures and a measure of overall subjective communication abilities (mini-Communicative Abilities Log (mini-CAL)). Clinicians treating patients (CIAT group) did not communicate with other team members to maintain blinding and the testing team members were blinded to treatment group assignment. Overall, the results of this pilot RCT support the results of previous observational studies that CIAT may lead to improvements in linguistic abilities. At 12 weeks, the treatment group reported better subjective communication abilities (mini-CAL) than the no-intervention group (p=0.019). Other measures trended towards better performance in the CIAT group. In this pilot RCT intensive language therapy led to an improvement in subjective language abilities. The effects demonstrated allow the design of a definitive trial of CIAT in patients with a variety of post-stroke aphasia types. In addition, our experiences have identified important considerations for designing subsequent trial(s) of CIAT or other interventions for post-stroke aphasia.

  17. COST EVALUATION OF AUTOMATED AND MANUAL POST- CONSUMER PLASTIC BOTTLE SORTING SYSTEMS

    Science.gov (United States)

    This project evaluates, on the basis of performance and cost, two Automated BottleSort® sorting systems for post-consumer commingled plastic containers developed by Magnetic Separation Systems. This study compares the costs to sort mixed bales of post-consumer plastic at these t...

  18. Trial 1 versus Trial 2 of the Test of Memory Malingering: Evaluating accuracy without a "gold standard".

    Science.gov (United States)

    Mossman, Douglas; Wygant, Dustin B; Gervais, Roger O; Hart, Kathleen J

    2018-01-01

    This study examines the accuracy of the Test of Memory Malingering (TOMM), a frequently administered measure for evaluating effort during neurocognitive testing. In the last few years, several authors have suggested that the initial recognition trial of the TOMM (Trial 1) might be a more useful index for detecting feigned or exaggerated impairment than Trial 2, which is the source for inference recommended by the original instruction manual (Tombaugh, 1996). We used latent class modeling (LCM) implemented in a Bayesian framework to evaluate archival Trial 1 and Trial 2 data collected from 1,198 adults who had undergone outpatient forensic evaluations. All subjects were tested with 2 other performance validity tests (the Word Memory Test and the Computerized Assessment of Response Bias), and for 70% of the subjects, data from the California Verbal Learning Test-Second Edition Forced Choice trial were also available. Our results suggest that not even a perfect score on Trial 1 or Trial 2 justifies saying that an evaluee is definitely responding genuinely, although such scores imply a lower-than-base-rate probability of feigning. If one uses a Trial 2 cut-off higher than the manual's recommendation, Trial 2 does better than Trial 1 at identifying individuals who are almost certainly feigning while maintaining a negligible false positive rate. Using scores from both trials, one can identify a group of definitely feigning and very likely feigning subjects who comprise about 2 thirds of all feigners; only 1% of the members of this group would not be feigning. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

  19. Effectiveness of two home ergonomic programs in reducing pain and enhancing quality of life in informal caregivers of post-stroke patients: A pilot randomized controlled clinical trial.

    Science.gov (United States)

    de Araújo Freitas Moreira, Karen Lucia; Ábalos-Medina, Gracia María; Villaverde-Gutiérrez, Carmen; Gomes de Lucena, Neide María; Belmont Correia de Oliveira, Anderson; Pérez-Mármol, José Manuel

    2018-02-13

    Informal caregivers of post-stroke patients usually undergo high levels of pain and stress and have a reduced quality of life. To evaluate the effectiveness of two home ergonomic interventions aimed at reducing pain intensity and perceived stress and enhancing the quality of life in informal caregivers of chronic post-stroke patients. A randomized single-blind controlled clinical trial was conducted, with a sample of 33 informal caregivers of patients with stroke. Three groups were included: one received postural hygiene training and kinesiotherapy, for 12 weeks, two days a week, one hour per session; another received adaptation of the home environment, and the third was a control group. Pain intensity, stress level and general quality of life were evaluated at three-time points: pre-intervention, post-intervention, and after a follow-up period of three months. Neck pain decreased in the two experimental groups, and increased in the control group. Pain in the shoulders and knees was alleviated in the group that received postural hygiene and kinesiotherapy. In addition, regarding quality of life, this group obtained an improvement in the physical health dimension, while the home adaptation group reported improved social relationships. These results suggest that 12 weeks of training in postural hygiene, combined with kinesiotherapy, and home adaptations can reduce pain and improve several aspects of the quality of life of this population. CLINICALTRIALS. NCT03284580. Copyright © 2018 Elsevier Inc. All rights reserved.

  20. Baseline vestibular and auditory findings in a trial of post-concussive syndrome

    Science.gov (United States)

    Meehan, Anna; Searing, Elizabeth; Weaver, Lindell; Lewandowski, Andrew

    2016-01-01

    Previous studies have reported high rates of auditory and vestibular-balance deficits immediately following head injury. This study uses a comprehensive battery of assessments to characterize auditory and vestibular function in 71 U.S. military service members with chronic symptoms following mild traumatic brain injury that did not resolve with traditional interventions. The majority of the study population reported hearing loss (70%) and recent vestibular symptoms (83%). Central auditory deficits were most prevalent, with 58% of participants failing the SCAN3:A screening test and 45% showing abnormal responses on auditory steady-state response testing presented at a suprathreshold intensity. Only 17% of the participants had abnormal hearing (⟩25 dB hearing loss) based on the pure-tone average. Objective vestibular testing supported significant deficits in this population, regardless of whether the participant self-reported active symptoms. Composite score on the Sensory Organization Test was lower than expected from normative data (mean 69.6 ±vestibular tests, vestibulo-ocular reflex, central auditory dysfunction, mild traumatic brain injury, post-concussive symptoms, hearing15.6). High abnormality rates were found in funduscopy torsion (58%), oculomotor assessments (49%), ocular and cervical vestibular evoked myogenic potentials (46% and 33%, respectively), and monothermal calorics (40%). It is recommended that a full peripheral and central auditory, oculomotor, and vestibular-balance evaluation be completed on military service members who have sustained head trauma.

  1. Randomized Evaluation of Cognitive-Behavioral Therapy and Graded Exercise Therapy for Post-Cancer Fatigue.

    Science.gov (United States)

    Sandler, Carolina X; Goldstein, David; Horsfield, Sarah; Bennett, Barbara K; Friedlander, Michael; Bastick, Patricia A; Lewis, Craig R; Segelov, Eva; Boyle, Frances M; Chin, Melvin T M; Webber, Kate; Barry, Benjamin K; Lloyd, Andrew R

    2017-07-01

    Cancer-related fatigue is prevalent and disabling. When persistent and unexplained, it is termed post-cancer fatigue (PCF). Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) may improve symptoms and functional outcomes. To evaluate the outcomes of a randomized controlled trial, which assigned patients with post-cancer fatigue to education, or 12 weeks of integrated cognitive-behavioral therapy (CBT) and graded exercise therapy (GET). Three months after treatment for breast or colon cancer, eligible patients had clinically significant fatigue, no comorbid medical or psychiatric conditions that explained the fatigue, and no evidence of recurrence. The CBT/GET arm included individually tailored consultations at approximately two weekly intervals. The education arm included a single visit with clinicians describing the principles of CBT/GET and a booklet. The primary outcome was clinically significant improvement in self-reported fatigue (Somatic and Psychological HEalth REport 0-12), designated a priori as greater than one SD of improvement in fatigue score. The secondary outcome was associated improvement in function (role limitation due to physical health problems-36-Item Short Form Health Survey 0-100) comparing baseline, end treatment (12 weeks), and follow-up (24 weeks). There were 46 patients enrolled, including 43 women (94%), with a mean age of 51 years. Fatigue severity improved in all subjects from a mean of 5.2 (±3.1) at baseline to 3.9 (±2.8) at 12 weeks, suggesting a natural history of improvement. Clinically significant improvement was observed in 7 of 22 subjects in the intervention group compared with 2 of 24 in the education group (P < 0.05, χ 2 ). These subjects also had improvement in functional status compared with nonresponders (P < 0.01, t-test). Combined CBT/GET improves fatigue and functional outcomes for a subset of patients with post-cancer fatigue. Further studies to improve the response rate and the magnitude of

  2. Post-trial apomorphine at an autoreceptor dose level can eliminate apomorphine conditioning and sensitization: support for the critical role of dopamine in re-consolidation.

    Science.gov (United States)

    Carrera, Marinete Pinheiro; Carey, Robert J; Cruz Dias, Flávia Regina; dos Santos Sampaio, Maria de Fátima; de Matos, Liana Wermelinger

    2013-01-01

    Re-exposure to conditioned drug stimuli triggers re-consolidation processes. In the present study post-trial apomorphine treatments were administered in order to interact with the re-consolidation of an apomorphine conditioned/sensitized locomotor response. A low (0.05 mg/kg) and a high (2.0mg/kg) dose were used to inhibit or to enhance dopamine activity, respectively. Initially, groups received 5 daily apomorphine (2.0mg/kg)/vehicle treatments either paired or unpaired to open-field placement. The paired treatments generated a progressive locomotor response. Subsequently, all groups received a 5 min non-drug test for conditioning and a conditioned locomotor response was observed in the paired group. The groups received another apomorphine (2.0mg/kg)/vehicle treatment as a re-induction treatment. At this stage the post-trial protocol was initiated. One set of paired, unpaired and vehicle groups were given a low dose of apomorphine (0.05 mg/kg) post-trial; another set received a high dose of apomorphine (2.0mg/kg) post-trial. The remaining group set received vehicle post-trial. The low dose post-trial treatment eliminated the conditioned and sensitized locomotor response and the high dose post-trial treatment enhanced the conditioned and sensitized locomotor response. The efficacy of the post-trial apomorphine treatments to modify the conditioned and the sensitized response after a brief non-drug exposure to test cues supports the proposition that exteroceptive cues control conditioning and sensitization and that the interoceptive drug cues make little or no associational contribution to apomorphine conditioning and sensitization. In addition, the findings point to the importance of dopamine activation in both the acquisition and re-consolidation of conditioning processes. Copyright © 2012 Elsevier B.V. All rights reserved.

  3. [Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

    Science.gov (United States)

    Liu, Huan; Xie, Yanming

    2011-10-01

    The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

  4. Combined Electrical Stimulation and Exercise for Swallow Rehabilitation Post-Stroke: A Pilot Randomized Control Trial

    Science.gov (United States)

    Sproson, Lise; Pownall, Sue; Enderby, Pam; Freeman, Jenny

    2018-01-01

    Background: Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post-stroke pneumonia, which causes 30% of stroke-related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post-stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted…

  5. Ex-post evaluation of Energy Investment Allowance (EIA); Ex-post evaluatie Energie Investeringsaftrek (EIA)

    Energy Technology Data Exchange (ETDEWEB)

    Aalbers, R.; Baarsma, B.; Berkhout, P.; Bremer, S.; Gerritsen, M.; De Nooij, M. [SEO Economisch Onderzoek, Amsterdam (Netherlands)

    2007-07-15

    In the framework of the VBTB ('Van Beleidsbegroting tot Beleidsverantwoording', or 'From budget to balance sheet') the EIA (Energy Investment Allowance) has been evaluated for the period 2001-2005. Attention has been paid to its relevancy and the (cost) effectiveness. [Dutch] In de context van de VBTB ('Van Beleidsbegroting tot Beleidsverantwoording', or 'From budget to balance sheet') is onderzocht of de EIA in de periode 2001 tot en met 2005 goed heeft gefunctioneerd. Daarbij is gekeken naar de relevantie van de EIA, de effectiviteit en kosteneffectiviteit van de EIA en is een evaluatie van de uitvoering gemaakt.

  6. Evaluation of the pattern dimensions of cast-metal posts in uniradicular teeth

    Directory of Open Access Journals (Sweden)

    Rafael de Assunção Vital

    Full Text Available Introduction Accurate dimensions of cast-metal posts are relevant to the survival of dental prostheses. Objective The aim of this study was to verify if the dimensions of cast-metal posts accord with ideal clinical criteria. Material and method For the evaluation, 285 periapical radiographs, from a total of 80 teeth, were taken from the charts of patients that attended the clinics at the Dental School of the Federal University of Goiás, from March 2008 to October 2012. Only periapical radiographs of single-rooted teeth with post and core were included in the study. The radiographic evaluation was conducted with the assistance of a magnifying glass and a view box, in a room with low luminosity. The dimensions of the post and core were established with the help of a digital caliper, and the following measurements were considered: a LR (Length Remnant; b LP (Length Post; c BS (Bone Support; d DR (Diameter Root; e DP (mesiodistal diameter post. The post and core were classified as acceptable or deficient by reference values with a margin of error of 0.2 mm. For descriptive analysis, the data were cataloged using SPSS software (version 17.0. Result With regard to the length of the post and core, only 26.25% and 43.75% of the post and core were classified as acceptable according to the two-thirds rule and fulcrum dental rule, respectively. With regard to the mesiodistal diameter of the post and core, 55% were classified as acceptable. Conclusion Within the limits of this study, it can be concluded that the cast-metal posts evaluated do not accord with the ideal clinical criteria.

  7. Post-deployment usability evaluation of a radiology workstation

    NARCIS (Netherlands)

    Jorritsma, Wiard; Cnossen, Fokie; Dierckx, Rudi A.; Oudkerk, Matthijs; Van Ooijen, Peter M. A.

    Objectives: To determine the number, nature and severity of usability issues radiologists encounter while using a commercially available radiology workstation in clinical practice, and to assess how well the results of a pre-deployment usability evaluation of this workstation generalize to clinical

  8. How to Evaluate Phase Differences between Trial Groups in Ongoing Electrophysiological Signals

    Science.gov (United States)

    VanRullen, Rufin

    2016-01-01

    A growing number of studies endeavor to reveal periodicities in sensory and cognitive functions, by comparing the distribution of ongoing (pre-stimulus) oscillatory phases between two (or more) trial groups reflecting distinct experimental outcomes. A systematic relation between the phase of spontaneous electrophysiological signals, before a stimulus is even presented, and the eventual result of sensory or cognitive processing for that stimulus, would be indicative of an intrinsic periodicity in the underlying neural process. Prior studies of phase-dependent perception have used a variety of analytical methods to measure and evaluate phase differences, and there is currently no established standard practice in this field. The present report intends to remediate this need, by systematically comparing the statistical power of various measures of “phase opposition” between two trial groups, in a number of real and simulated experimental situations. Seven measures were evaluated: one parametric test (circular Watson-Williams test), and three distinct measures of phase opposition (phase bifurcation index, phase opposition sum, and phase opposition product) combined with two procedures for non-parametric statistical testing (permutation, or a combination of z-score and permutation). While these are obviously not the only existing or conceivable measures, they have all been used in recent studies. All tested methods performed adequately on a previously published dataset (Busch et al., 2009). On a variety of artificially constructed datasets, no single measure was found to surpass all others, but instead the suitability of each measure was contingent on several experimental factors: the time, frequency, and depth of oscillatory phase modulation; the absolute and relative amplitudes of post-stimulus event-related potentials for the two trial groups; the absolute and relative trial numbers for the two groups; and the number of permutations used for non-parametric testing

  9. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

    Science.gov (United States)

    Endrikat, J; Schwenke, C; Prince, M R

    2015-07-01

    To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

  10. Tranexamic acid for treatment of women with post-partum haemorrhage in Nigeria and Pakistan: a cost-effectiveness analysis of data from the WOMAN trial.

    Science.gov (United States)

    Li, Bernadette; Miners, Alec; Shakur, Haleema; Roberts, Ian

    2018-02-01

    Sub-Saharan Africa and southern Asia account for almost 85% of global maternal deaths from post-partum haemorrhage. Early administration of tranexamic acid, within 3 h of giving birth, was shown to reduce the risk of death due to bleeding in women with post-partum haemorrhage in the World Maternal Antifibrinolytic (WOMAN) trial. We aimed to assess the cost-effectiveness of early administration of tranexamic acid for treatment of post-partum haemorrhage. For this economic evaluation we developed a decision model to assess the cost-effectiveness of the addition of tranexamic acid to usual care for treatment of women with post-partum haemorrhage in Nigeria and Pakistan. We used data from the WOMAN trial to inform model parameters, supplemented by estimates from the literature. We estimated costs (calculated in 2016 US$), life-years, and quality-adjusted life-years (QALYs) with and without tranexamic acid, calculated incremental cost-effectiveness ratios (ICERs), and compared these to threshold values in each country. Costs were assessed from the health-care provider perspective and discounted at 3% per year in the base case analysis. We did a series of one-way sensitivity analyses and probabilistic sensitivity analysis to assess the robustness of the results to parameter uncertainty. Early treatment of post-partum haemorrhage with tranexamic acid generated an average gain of 0·18 QALYs at an additional cost of $37·12 per patient in Nigeria and an average gain of 0·08 QALYs at an additional cost of $6·55 per patient in Pakistan. The base case ICER results were $208 per QALY in Nigeria and $83 per QALY in Pakistan. These ICERs were below the lower bound of the cost-effectiveness threshold range in both countries. The ICERs were most sensitive to uncertainty in parameter inputs for the relative risk of death due to bleeding with tranexamic acid, the discount rate, the cost of the drug, and the baseline probability of death due to bleeding. Early treatment of post

  11. Systematic Evaluation of Promising Clinical Trials-Gene Silencing for the Treatment of Glioblastoma.

    Science.gov (United States)

    Karaarslan, Numan; Yilmaz, Ibrahim; Ozbek, Hanefi; Caliskan, Tezcan; Topuk, Savas; Sirin, Duygu Yasar; Ates, Ozkan

    2018-04-06

    The aim of this study was to systematically investigate the role of artificial small interfering RNA (siRNA) molecules in glioblastoma treatment and to give a detailed overview of the literature concerning studies performed in this field worldwide in the last 31 years. Articles about clinical trials conducted between December 1, 1949 and November 8, 2017, were identified from the Cochrane Collaboration, the Cochrane Library, Ovid MEDLINE, ProQuest, the National Library of Medicine, and PubMed electronic databases, using the terms "post transcriptional gene silencing," "small interfering RNA," "siRNA," and "glioblastoma," either individually or combined (\\"OR\\" and \\"AND"), without language and country restrictions. Articles that met the examination criteria were included in the study. After descriptive statistical evaluation, the results were reported in frequency (%). After scanning 2.752 articles, five articles were found that met the research criteria. Examination of full texts of the five identified articles provided no sufficient evidence for research conducted with regard to the use of gene silencing via siRNAs in glioblastoma treatment. To be able to evaluate the clinical use of siRNAs, there is an urgent need for in-vivo studies and for trials with randomized, controlled, and clinical designs that provide long-term functional outcomes.

  12. Evaluation of a cognitive psychophysiological model for management of tic disorders: an open trial.

    Science.gov (United States)

    O'Connor, Kieron; Lavoie, Marc; Blanchet, Pierre; St-Pierre-Delorme, Marie-Ève

    2016-07-01

    Tic disorders, in particular chronic tic disorder and Tourette syndrome, affect about 1% of the population. The current treatment of choice is pharmacological or behavioural, addressing tics or the premonitory urges preceding tic onset. The current study reports an open trial evaluating the effectiveness of a cognitive psychophysiological treatment addressing Tourette-specific sensorimotor activation processes rather than the tic. Forty-nine people with Tourette syndrome and 36 people with chronic tics completed 10 weeks of individual cognitive psychophysiological therapy. Outcome measures included two tic severity scales and psychosocial measures. Post-treatment both groups had significantly improved on the tic scales with strong effect sizes across tic locations and complex and simple tics, maintained at 6-month follow-up with further change in perfectionism and self-esteem. The cognitive psychophysiological approach targeting underlying sensorimotor processes rather than tics in Tourette's and chronic tic disorder reduced symptoms with a large effect size. © The Royal College of Psychiatrists 2016.

  13. Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

    DEFF Research Database (Denmark)

    Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed

    2016-01-01

    BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...... included myocardial infarction, other heart disease, and acute coronary syndrome or death. Data were analysed in the Cox proportional hazards model. RESULTS: The primary outcome, acute coronary syndrome, occurred in 2.5% versus 1.3% in the 80% versus 30% oxygen group; HR 2.15 (95% CI 0.96-4.84). Patients...

  14. A post hoc assessment of duration of protection in CAPiTA (Community Acquired Pneumonia immunization Trial in Adults)

    NARCIS (Netherlands)

    Patterson, Scott; Webber, Chris; Patton, Michael; Drews, Wayne; Huijts, Susanne M.; Bolkenbaas, Marieke; Gruber, William C.; Scott, Daniel A.; Bonten, Marc J M

    2016-01-01

    Background: The Community Acquired Pneumonia immunization Trial in Adults (CAPiTA) was conducted to evaluate 13-valent pneumococcal conjugate vaccine (PCV13) for the prevention of vaccine-type community-acquired pneumonia (VT-CAP) and vaccine-type invasive pneumococcal disease (VT-IPD) in adults

  15. Post design evaluation (ageing mechanisms, effects, management, monitoring, PSR, ISI)

    International Nuclear Information System (INIS)

    Ichikawa, Toshio

    2001-01-01

    Although the nuclear plant was designed for the purpose of the 30-year life the early stages of construction, it also already has the plant abolished by passing in 30 years. There is a plant under operation and a plant that is employed variously, extends the original life and continues operation now, and the plant that is going to be abolished politically is before a life. By using a nuclear plant for a long period of time, damage. by the influence of irradiation, wear of slipping, corrosion, etc. appears. When this degradation is left, the serious accident is caused. In this lecture, refer to Assessment and management of ageing of major nuclear power plant components important to safety, Oct. 1999 of IAEA. A point of view from guide is introduced about management of the mechanism in the secular degradation mode expected by operating for a long period of time, the influence of secular degradation, and influence, monitoring technology, periodical safe evaluation, and a periodic inspection. And raises and explains the correspondence situation of secular degradation, and the example of evaluation of PSR and ISI equipment. The aging mechanism for reactor vessel internal components considered are related to embrittlement, fatigue, corrosion, radiation induced creep, relaxation and swelling, and mechanical wear. This lecture includes; monitoring methods, a description of periodic safety reviews and a sample of seismic design periodic safety report for the reactor internals

  16. The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial

    DEFF Research Database (Denmark)

    Chung, Eugene S; Fischer, Trent M; Kueffer, Fred

    2015-01-01

    BACKGROUND: Despite considerable improvements in the medical management of patients with myocardial infarction (MI), patients with large MI still have substantial risk of developing heart failure. In the early post-MI setting, implantable cardioverter defibrillators have reduced arrhythmic deaths...

  17. Glyceryl trinitrate for prevention of post-ERCP pancreatitis and improve the rate of cannulation: a meta-analysis of prospective, randomized, controlled trials.

    Directory of Open Access Journals (Sweden)

    Jiexia Ding

    Full Text Available BACKGROUND: Acute pancreatitis is the most common complication of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP. Several clinical trials used glyceryl trinitrate (GTN to prevent the incidence of post-ERCP pancreatitis (PEP. However, the results were still controversial. OBJECTIVE: To conduct a meta-analysis of published, full-length, randomized controlled trials evaluating the effect of prophylactic GTN on the prevention of PEP, improve the rate of cannulation and the prevention of hyperamylasemia. METHODS: Literature searches were conducted using PubMed, EMBASE, The Cochrane Library and Web of Knowledge databases, using keywords "post-ERCP" and "pancreatitis" and limited in randomized controlled trials. RESULTS: Twelve RCTs involving 2649 patients were included. Eleven RCTs compared GTN with placebo for PEP prevention. Meta-analysis showed the overall incidence of PEP was significantly reduced by GTN treatment (RR 0.67; 95% CI, 0.52-0.87. Nevertheless, GTN administration did not decrease the incidence of moderate to severe PEP (RR 0.70; 95% CI, 0.42-1.15. Subgroup analyses revealed that GTN administered by sublingual was more effective than transdermal and topical in reducing the incidence of PEP. Besides, the prophylactic effect of GTN was far more obvious in the group of high PEP incidence than in the group of low PEP incidence. Additionally, the incidence of hyperamylasemia was significantly reduced by GTN treatment (RR 0.69; 95% CI, 0.54-0.90. No differences of the successful cannulation rate of bile ducts (RR 1.03; 95% CI, 0.99-1.06 attributable to GTN were observed. CONCLUSION: Prophylactic use of GTN reduced the overall incidence of PEP and hyperamylasemia. However, GTN was not helpful for the severity of PEP and the rate of cannulation.

  18. Combined Interval Training and Post-exercise Nutrition in Type 2 Diabetes: A Randomized Control Trial

    OpenAIRE

    Francois, Monique E.; Durrer, Cody; Pistawka, Kevin J.; Halperin, Frank A.; Chang, Courtney; Little, Jonathan P.

    2017-01-01

    Background: High-intensity interval training (HIIT) can improve several aspects of cardiometabolic health. Previous studies have suggested that adaptations to exercise training can be augmented with post-exercise milk or protein consumption, but whether this nutritional strategy can impact the cardiometabolic adaptations to HIIT in type 2 diabetes is unknown. Objective: To determine if the addition of a post-exercise milk or protein beverage to a high-intensity interval training (HIIT) interv...

  19. Reducing child abuse amongst adolescents in low- and middle-income countries: A pre-post trial in South Africa.

    Science.gov (United States)

    Cluver, Lucie; Meinck, Franziska; Yakubovich, Alexa; Doubt, Jenny; Redfern, Alice; Ward, Catherine; Salah, Nasteha; De Stone, Sachin; Petersen, Tshiamo; Mpimpilashe, Phelisa; Romero, Rocio Herrero; Ncobo, Lulu; Lachman, Jamie; Tsoanyane, Sibongile; Shenderovich, Yulia; Loening, Heidi; Byrne, Jasmina; Sherr, Lorraine; Kaplan, Lauren; Gardner, Frances

    2016-07-13

    No known studies have tested the effectiveness of child abuse prevention programmes for adolescents in low- or middle-income countries. 'Parenting for Lifelong Health' ( http://tiny.cc/whoPLH ) is a collaborative project to develop and rigorously test abuse-prevention parenting programmes for free use in low-resource contexts. Research aims of this first pre-post trial in South Africa were: i) to identify indicative effects of the programme on child abuse and related outcomes; ii) to investigate programme safety for testing in a future randomised trial, and iii) to identify potential adaptations. Two hundred thirty participants (adolescents and their primary caregivers) were recruited from schools, welfare services and community-sampling in rural, high-poverty South Africa (no exclusion criteria). All participated in a 12-week parenting programme, implemented by local NGO childcare workers to ensure real-world external validity. Standardised pre-post measures with adolescents and caregivers were used, and paired t-tests were conducted for primary outcomes: abuse (physical, emotional abuse and neglect), adolescent behaviour problems and parenting (positive and involved parenting, poor monitoring and inconsistent discipline), and secondary outcomes: mental health, social support and substance use. Participants reported high levels of socio-economic deprivation, e.g. 60 % of adolescents had either an HIV-positive caregiver or were orphaned by AIDS, and 50 % of caregivers experienced intimate partner violence. i) indicative effects: Primary outcomes comparing pre-test and post-test assessments showed reductions reported by adolescents and caregivers in child abuse (adolescent report 63.0 % pre-test to 29.5 % post-test, caregiver report 75.5 % pre-test to 36.5 % post-test, both p child abuse and improved caregiver and adolescent outcomes. It showed high acceptability and unexpected community-level diffusion. Findings indicate needs for adaptations, and

  20. Effect of ultraviolet light irradiation on bond strength of fiber post: Evaluation of surface characteristic and bonded area of fiber post with resin cement

    OpenAIRE

    Reza, Fazal; Ibrahim, Nur Sukainah

    2015-01-01

    Objective: Fiber post is cemented to a root canal to restore coronal tooth structure. This research aims to evaluate the effect of ultraviolet (UV) irradiation on bond strength of fiber post with resin cement. Materials and Methods: A total of 40 of the two types of fiber posts, namely, FRC Prostec (FRC) and Fiber KOR (KOR), were used for the experiment. UV irradiation was applied on top of the fiber post surface for 0, 15, 20, and 30 min. The irradiated surface of the fiber posts (n = 5) wer...

  1. Evaluation of mobility and functionality outcomes post cerebrovascular accident

    Directory of Open Access Journals (Sweden)

    Jeanne Caldas Carvalho

    2013-12-01

    Introduction: individuals with cerebrovascular accident (CVA have sequels that interfere with its functionality and mobility and undertake activities of daily living (Dlas. Objectives: the aim of this study was to correlate the mobility with functional independence in people with sequelae of CVA. Methods: the 19 volunteers were evaluated through Functional independence measurement and Time Up and Go. The descriptive analysis of data was performed by statistics percentage, average, and standard deviation and the Pearson Correlation was used to analyze the correlation of variables in the study. Results: the statistical analysis on the functional independence pointed out that 52.6% of individuals require 25% more aid in the performance of daily activities. In relation to mobility, 63.1% of participants needed more than 20 seconds to perform the Time Up and Go. There was a negative correlation (r = - 0.6 between the functionality and mobility in individuals affected by CVA (p < 0.05. It is concluded that the performance of the individual affected by a CVA is related to the level of mobility. This study supports new studies which can develop new hypotheses.

  2. Evaluation of eligibility and recruitment in breast cancer clinical trials.

    Science.gov (United States)

    Lemieux, Julie; Forget, Geneviève; Brochu, Olyvia; Provencher, Louise; Cantin, Guy; Desbiens, Christine; Doyle, Catherine; Poirier, Brigitte; Camden, Stéphanie; Durocher, Martin

    2014-08-01

    Objectives of the study were to measure recruitment rates in clinical trials and to identify patients, physicians or trials characteristics associated with higher recruitment rates. Among patients who had a clinical trial available for their cancer, 83.5% (345/413) met the eligibility criteria to at least one clinical trial. At least one trial was proposed to 33.1% (113/341) of the eligible patients and 19.7% (68/345) were recruited. Overall recruitment was 16.5% (68/413). In multivariate analyses, trial proposal and enrollment were lower for elderly patients and higher in high cancer stages. Trials from pharmaceutical industry had higher recruitment rates and trials testing hormonal therapy enrolled more patients. Breast cancer patients' accrual to a clinical trial could be improved by trying to systematically identify all eligible patients and propose a trial to those eligible and to whom the treatment is planned to be equivalent to the standard arm of the trial. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Fisher Beth E

    2010-10-01

    Full Text Available Abstract Background Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. Methods/Design We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. Discussion This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. Trial Registration http://www.clinicaltrials.gov identifier NCT00888498.

  4. Are we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bone Kerry M

    2009-06-01

    Full Text Available Abstract Background Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms. Methods A post hoc analysis was conducted on data from 93 participants who completed this previously published study. Variables at baseline were investigated as potential predictors of the response on any of the endpoints of flushing, overall menopausal symptoms and depression. Focused tests were conducted using hierarchical linear regression analyses. Based on these findings, analyses were conducted for both groups separately. These findings are discussed in relation to existing literature on placebo effects. Results Distinct differences in predictors were observed between the placebo and active groups. A significant difference was found for study entry anxiety, and Greene Climacteric Scale (GCS scores, on all three endpoints. Attitude to menopause was found to differ significantly between the two groups for GCS scores. Examination of the individual arms found anxiety at study entry to predict placebo response on all three outcome measures individually. In contrast, low anxiety was significantly associated with improvement in the active treatment group. None of the variables found to predict the placebo response was relevant to the treatment arm. Conclusion This study was a post hoc analysis

  5. Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Huang, Jia; McCaskey, Michael A; Yang, Shanli; Ye, Haicheng; Tao, Jing; Jiang, Cai; Schuster-Amft, Corina; Balzer, Christian; Ettlin, Thierry; Schupp, Wilfried; Kulke, Hartwig; Chen, Lidian

    2015-12-02

    A majority of stroke survivors present with cognitive impairments. Attention disturbance, which leads to impaired concentration and overall reduced cognitive functions, is strongly associated with stroke. The clinical efficacy of acupuncture with Baihui (GV20) and Shenting (GV24) as well as computer-assisted cognitive training in stroke and post-stroke cognitive impairment have both been demonstrated in previous studies. To date, no systematic comparison of these exists and the potential beneficial effects of a combined application are yet to be examined. The main objective of this pilot study is to evaluate the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The second objective is to test the effects of a combined cognitive intervention that incorporates computer-assisted cognitive training and acupuncture (ACoTrain). An international multicentre, single-blinded, randomised controlled pilot trial will be conducted. In a 1:1:1 ratio, 60 inpatients with post-stroke cognitive dysfunction will be randomly allocated into either the acupuncture group, the computer-assisted cognitive training group, or the ACoTrain group in addition to their individual rehabilitation programme. The intervention period of this pilot trial will last 4 weeks (30 minutes per day, 5 days per week, Monday to Friday). The primary outcome is the test battery for attentional performance. The secondary outcomes include the Trail Making Test, Test des Deux Barrages, National Institute of Health Stroke Scale, and Modified Barthel Index for assessment of daily life competence, and the EuroQol Questionnaire for health-related quality of life. This trial mainly focuses on evaluating the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The results of this pilot trial are expected to provide new insights on how Eastern and Western medicine can complement one another and

  6. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hart Michael B

    2010-10-01

    Full Text Available Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools in Perth, Australia were recruited to the clustered (by school randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide

  7. Prevention effect of allopurinol on post-endoscopic retrograde cholangiopancreatography pancreatitis: a meta-analysis of prospective randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Wei-Li Cao

    Full Text Available BACKGROUND: Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP which can be severe and cause death in approximately 10% of cases. Up to now, six randomized controlled trials (RCTs have been found relevant to the effect of allopurinol on prevention of Post-ERCP pancreatitis (PEP. However, these results remained controversial. OBJECTIVE: To conduct a meta-analysis with RCTs published in full text to determine the effectiveness of prophylactic allopurinol of different dosages and administration time in the incidence and severity of PEP. METHODS: Literature search was performed in PubMed, Embase, Web of Science and Cochrane Library from databases inception to May 2014. RCTs comparing the effect of allopurinol with placebo on prevention of PEP were included. Statistical heterogeneity was quantitatively evaluated byχ2 test with the significance set P50%. RESULTS: Six RCTs consisting of 1974 participants were eventually included. The incidences of PEP in allopurinol group and placebo group were 8.4%(83/986 and 9.9%(98/988 respectively. Meta-analysis showed no evident prevention effect of allopurinol on the incidence of PEP (RR 0.75, 95%CI 0.39-1.42 with significant heterogeneity (I2 = 70.4%, P = 0.005. When studies were stratified according to the dosages and administration time of allopurinol they applied, there was still no evident prevention effect of allopurinol on mild, moderate or severe PEP. However, statistically substantial heterogeneity was presented in the subgroup of moderate PEP when the effect of high dose of allopurinol was analyzed (Imoderate2 = 82.3%, Pmoderate = 0.018. Statistically significant heterogeneity was also observed in subgroup of mild PEP, when the effect of long adminstration time of allopurinol was investigated (Imild2 = 62.8%, Pmild = 0.068. CONCLUSION: The prophylactic use of allopurinol in different dosages and administration time had no effect

  8. Effectiveness of post-discharge case management in general-medical outpatients: a randomized, controlled trial

    NARCIS (Netherlands)

    Latour, Corine H. M.; de Vos, Rien; Huyse, Frits J.; de Jonge, Peter; van Gemert, Liesbeth A. M.; Stalman, Wim A. B.

    2006-01-01

    This study was initiated to determine the impact of post-discharge, nurse-led, home-based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N=147) were

  9. Effectiveness of post-discharge case management in general-medical outpatients: A randomized, controlled trial

    NARCIS (Netherlands)

    Latour-Delfgaauw, C.H.M.; Vos, R.; Huyse, F.J.; de Jonge, P.; van Gemert, L.A.M.; Stalman, W.A.B.

    2006-01-01

    This study was initiated to determine the impact of post-discharge, nurse-led, home-based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N=147) were

  10. Effectiveness of post-discharge case management in general-medical outpatients: A randomized, controlled trial

    NARCIS (Netherlands)

    Latour, C.H.M.; de Vos, R.; Huyse, F.J.; De Jonge, P.; van Gemert, L.A.M.; Stalman, W.A.B.

    2006-01-01

    This study was initiated to determine the impact of post- discharge, nurse- led, home- based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N = 147)

  11. Effectiveness of post-discharge case management in general-medical outpatients : A randomized, controlled trial

    NARCIS (Netherlands)

    Latour, Corine H. M.; de Vos, Rien; Huyse, Frits J.; de Jonge, Peter; van Gemert, Liesbeth A. M.; Stalman, Wim A. B.

    2006-01-01

    This study was initiated to determine the impact of post- discharge, nurse- led, home- based case management intervention on the number of emergency readmissions, level of care utilization, quality of life, and psychological functioning. Patients discharged home from a general hospital (N = 147)

  12. Evaluating Post-Radiotherapy Laryngeal Function with Laryngeal Videostroboscopy in Early Stage Glottic Cancer

    Directory of Open Access Journals (Sweden)

    Ariel E. Marciscano

    2017-06-01

    Full Text Available ObjectiveDysphonia is common among patients with early stage glottic cancer. Laryngeal videostroboscopy (LVS has not been routinely used to assess post-radiotherapy (RT voice changes. We hypothesized that LVS would demonstrate improvement in laryngeal function after definitive RT for early-stage glottic cancer.Study designBlinded retrospective review of perceptual voice and stroboscopic parameters for patients with early glottic cancer and controls.SettingHigh-volume, single-institution academic medical center.Subjects and methodsFifteen patients underwent RT for Tis-T2N0M0 glottic cancer and were evaluated with serial LVS exams pre- and post-RT. Stroboscopic assessment included six parameters: vocal fold (VF vibration, VF mobility, erythema/edema, supraglottic compression, glottic closure, and secretions. Grade, roughness, breathiness, asthenia, strain (GRBAS voice perceptual scale was graded in tandem with LVS score. Assessments were grouped by time interval from RT: pre-RT, 0–4, 4–12, and >12 months post-RT.Results60 LVS exams and corresponding GRBAS assessments were reviewed. There were significant improvements in ipsilateral VF motion (P = 0.03 and vibration (P = 0.001 and significant worsening in contralateral VF motion (P < 0.001 and vibration (P = 0.008 at >12 months post-RT. Glottic closure significantly worsened, most prominent >12 months post-RT (P = 0.01. Composite GRBAS scores were significantly improved across all post-RT intervals.ConclusionLVS proved to be a robust tool for assessing pre- and post-RT laryngeal function. We observed post-RT improvement in ipsilateral VF function, a decline in contralateral VF function, and decreased glottic closure. These results demonstrate that LVS can detect meaningful changes in VF and glottic function and support its use for post-RT evaluation of glottic cancer patients.

  13. Castor oil for induction of labor in post-date pregnancies: A randomized controlled trial.

    Science.gov (United States)

    Gilad, Ronit; Hochner, Hagit; Savitsky, Bella; Porat, Shay; Hochner-Celnikier, Drorith

    2018-02-01

    Castor oil is a substance used for labor induction in an inpatient setting. However, its efficacy as an agent for the induction of labor, for post-date pregnancies in an outpatient setup is unknown. Efficacy of castor oil as an agent for the induction of labor, for post-date pregnancies in outpatient settings. Eighty-one women with a low-risk post-date singleton pregnancy with a Bishop score≤7, without effective uterine contractions were randomized to the intervention, 60ml of castor oil, or the control, 60ml of sun-flower oil. The primary outcome was proportion of women entering the active phase of labor 24, 36, 48h after ingestion. Secondary outcomes included meconium stained amniotic fluid, abnormal fetal heart rate tracing, cesarean section rate, instrumental deliveries, birth weight, 5min Apgar score, chorioamnionitis, hypertensive complications, retained placenta, and post-partum hemorrhage. Intervention and control groups included 38 and 43 women, respectively. No differences in baseline characteristics, except for age were noted. The observed interaction between castor oil and parity was significant (p interaction =0.02). Multiparous women in the intervention group exhibited a significant beneficial effect on entering active labor within 24, 36 and 48h after castor oil consumption compared with the placebo (Hazard Ratio=2.93, p=0.048; Hazard Ratio=3.29, p=0.026; Hazard Ratio=2.78, p=0.042 respectively). This effect was not noted among primiparous women. No differences in rate of obstetric complications or adverse neonatal outcomes were noted. Castor oil is effective for labor induction, in post-date multiparous women in outpatient settings. Copyright © 2017. Published by Elsevier Ltd.

  14. Confirmatory factor analysis of Post-Occupancy Evaluation Model (POEM) for sustainable neighborhood development

    Science.gov (United States)

    Yaman, R.; Thadaniti, S.; Abdullah, J.; Ahmad, N.; Ishak, N. M.

    2018-02-01

    The sustainable urban development growth in the ASEAN region has accelerated tremendously. More demand on the sustainable development has led to bigger market driven certified green neighborhood and buildings. However, there is a lack of post-occupancy evaluation study conducted in assessing the end-users perspective on the certified sustainable neighborhood development. This paper aims to investigate the end-users point of view on sustainable dimension pillar (SDP) adaptation based on environment dimension, social dimension and economic dimension using Post-Occupancy Evaluation Model (POEM) framework. The research methodology employed stakeholders-Inclusion Approach survey questionnaires in order to obtained the sustainable dimensional adaptation score. The results show that there is sustainable dimension gap in POEM evaluation, hence, suggested the pre- occupancy criteria did not fulfill the SDP adaptation and pre-occupancy criteria and variables if differ from post-occupancy criteria and variables.

  15. Comparison of Single Visit Post Endodontic Pain Using Mtwo Rotary and Hand K-File Instruments: A Randomized Clinical Trial.

    Science.gov (United States)

    Kashefinejad, Mohamad; Harandi, Azade; Eram, Saeed; Bijani, Ali

    2016-01-01

    Pain is an unpleasant outcome of endodontic treatment that can be unbearable to patients. Instrumentation techniques may affect the frequency and intensity of post-endodontic pain. This study aimed to compare single visit post endodontic pain using Mtwo (NiTi) rotary and hand K-file instruments. In this randomized controlled trial, 60 teeth with symptomatic irreversible pulpitis in 53 patients were selected and randomly assigned into two groups of 30 teeth. In group A, the root canals were prepared with Mtwo (NiTi) rotary instruments. In group B, the root canals were prepared with hand K-file instruments. Pain assessment was implemented using visual analog scale (VAS) at four, eight, 12 and 24 hours after treatment. The acquired data were analyzed using chi-square, Mann-Whitney U and Student's t-test (Protary instruments experienced significantly less post-endodontic pain than those treated with hand instruments (Protary instruments in root canal preparation contributed to lower incidence of postoperative pain than hand K-files.

  16. Comparison of Single Visit Post Endodontic Pain Using Mtwo Rotary and Hand K-File Instruments: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mohamad Kashefinejad

    2016-08-01

    Full Text Available Objectives: Pain is an unpleasant outcome of endodontic treatment that can be unbearable to patients. Instrumentation techniques may affect the frequency and intensity of post-endodontic pain. This study aimed to compare single visit post endodontic pain using Mtwo (NiTi rotary and hand K-file instruments.Materials and Methods: In this randomized controlled trial, 60 teeth with symptomatic irreversible pulpitis in 53 patients were selected and randomly assigned into two groups of 30 teeth. In group A, the root canals were prepared with Mtwo (NiTi rotary instruments. In group B, the root canals were prepared with hand K-file instruments. Pain assessment was implemented using visual analog scale (VAS at four, eight, 12 and 24 hours after treatment. The acquired data were analyzed using chi-square, Mann-Whitney U and Student’s t-test (P<0.05.Results: Patients treated with rotary instruments experienced significantly less post-endodontic pain than those treated with hand instruments (P<0.001.Conclusion: The use of Mtwo (NiTi rotary instruments in root canal preparation contributed to lower incidence of postoperative pain than hand K-files.

  17. Indomethacin and diclofenac in the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis of prospective controlled trials.

    Science.gov (United States)

    Patai, Árpád; Solymosi, Norbert; Mohácsi, László; Patai, Árpád V

    2017-06-01

    Diclofenac and indomethacin are the most studied drugs for preventing post-ERCP pancreatitis (PEP). However, there are no prospective, randomized multicenter trials with a sufficient number of patients for correct evaluation of their efficacy. Our aim was to evaluate all prospective trials published in full text that studied the efficacy of diclofenac or indomethacin and were controlled with placebo or non-treatment for the prevention of PEP in adult patients undergoing ERCP. Systematic search of databases (PubMed, Scopus, Web of Science, Cochrane) for relevant studies published from inception to 30 June 2016. Our meta-analysis of 4741 patients from 17 trials showed that diclofenac or indomethacin significantly decreased the risk ratio (RR) of PEP to 0.60 (95% confidence interval [CI], 0.46-0.78; P = .0001), number needed to treat (NNT) was 20, and the reduction of RR of moderate to severe PEP was 0.64 (95% CI, 0.43-0.97; P = .0339). The efficacy of indomethacin compared with diclofenac was similar (P = .98). The efficacy of indomethacin or diclofenac did not differ according to timing (P = .99) or between patients with average-risk and high-risk for PEP (P = .6923). The effect of non-rectal administration of indomethacin or diclofenac was not significant (P = .1507), but the rectal route was very effective (P = .0005) with an NNT of 19. The administration of indomethacin or diclofenac was avoided in patients with renal failure. Substantial adverse events were not detected. The use of rectally administered diclofenac or indomethacin before or closely after ERCP is inexpensive and safe and is recommended in every patient (without renal failure) undergoing ERCP. (Registration number: CRD42016042726, http://www.crd.york.ac.uk/prospero/.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  18. Live-attenuated tetravalent dengue vaccines: The needs and challenges of post-licensure evaluation of vaccine safety and effectiveness.

    Science.gov (United States)

    Wichmann, Ole; Vannice, Kirsten; Asturias, Edwin J; de Albuquerque Luna, Expedito José; Longini, Ira; Lopez, Anna Lena; Smith, Peter G; Tissera, Hasitha; Yoon, In-Kyu; Hombach, Joachim

    2017-10-09

    Since December 2015, the first dengue vaccine has been licensed in several Asian and Latin American countries for protection against disease from all four dengue virus serotypes. While the vaccine demonstrated an overall good safety and efficacy profile in clinical trials, some key research questions remain which make risk-benefit-assessment for some populations difficult. As for any new vaccine, several questions, such as very rare adverse events following immunization, duration of vaccine-induced protection and effectiveness when used in public health programs, will be addressed by post-licensure studies and by data from national surveillance systems after the vaccine has been introduced. However, the complexity of dengue epidemiology, pathogenesis and population immunity, as well as some characteristics of the currently licensed vaccine, and potentially also future, live-attenuated dengue vaccines, poses a challenge for evaluation through existing monitoring systems, especially in low and middle-income countries. Most notable are the different efficacies of the currently licensed vaccine by dengue serostatus at time of first vaccination and by dengue virus serotype, as well as the increased risk of dengue hospitalization among young vaccinated children observed three years after the start of vaccination in one of the trials. Currently, it is unknown if the last phenomenon is restricted to younger ages or could affect also seronegative individuals aged 9years and older, who are included in the group for whom the vaccine has been licensed. In this paper, we summarize scientific and methodological considerations for public health surveillance and targeted post-licensure studies to address some key research questions related to live-attenuated dengue vaccines. Countries intending to introduce a dengue vaccine should assess their capacities to monitor and evaluate the vaccine's effectiveness and safety and, where appropriate and possible, enhance their surveillance

  19. Does participating in a clinical trial affect subsequent nursing management? Post-trial care for participants recruited to the INTACT pressure ulcer prevention trial: A follow-up study.

    Science.gov (United States)

    Webster, Joan; Bucknall, Tracey; Wallis, Marianne; McInnes, Elizabeth; Roberts, Shelley; Chaboyer, Wendy

    2017-06-01

    Participation in a clinical trial is believed to benefit patients but little is known about the post-trial effects on routine hospital-based care. To describe (1) hospital-based, pressure ulcer care-processes after patients were discharged from a pressure ulcer prevention, cluster randomised controlled trial; and (2) to investigate if the trial intervention had any impact on subsequent hospital-based care. We conducted a retrospective analysis of 133 trial participants who developed a pressure ulcer during the clinical trial. We compared outcomes and care processes between participants who received the pressure ulcer prevention intervention and those in the usual care, control group. We also compared care processes according to the pressure ulcer stage. A repositioning schedule was reported for 19 (14.3%) patients; 33 (24.8%) had a dressing applied to the pressure ulcer; 17 (12.8) patients were assessed by a wound care team; and 20 (15.0%) were seen by an occupational therapist. Patients in the trial's intervention group were more likely to have the presence of a pressure ulcer documented in their chart (odds ratio (OR) 8.18, 95% confidence intervals (CI) 3.64-18.36); to be referred to an occupational therapist OR 0.92 (95% CI 0.07; 0.54); to receive a pressure relieving device OR 0.31 (95% CI 0.14; 0.69); or a pressure relieving mattress OR 0.44 (95% CI 0.20; 0.96). Participants with Stage 2 or unstageable ulcers were more likely than others to have dressings applied to their wounds (p=pressure ulcer status and care is poor. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. The Evaluation of Yellow vs. Blue Color Contrast Sensitivity pre and Post LASIK

    Directory of Open Access Journals (Sweden)

    S. Heydarian

    2007-06-01

    Full Text Available Introduction: contrast sensitivity is one of the most important psychophysical tests that may be used for the evaluation of refractive state of eye and retinal image quality. Yellow vs. blue color contrast sensitivity may be more suitable in this regard. Materials and Methods: thirty myopic eyes were considered in this study. Yellow vs. blue color contrast sensitivity was evaluated under the same environment and conditions in these individuals pre and post LASIK. Results: The comparison of yellow vs. blue color contrast sensitivity with glasses pr e and post LASIK shows a significant improvement (p

  1. Improving non-technical skills (teamwork) in post-partum haemorrhage: A grouped randomised trial.

    Science.gov (United States)

    Letchworth, Pippa M; Duffy, Shane P; Phillips, Dan

    2017-10-01

    To determine the effect of a decision support technology on teamwork and associated non-technical (NTS) and technical skills when teams manage post-partum haemorrhage (PPH) in the simulated environment. Multidisciplinary (MDT) maternity teams were taught how to manage post partum haemorrhage. They were randomised to the intervention: using a decision support mobile digital platform or a control group. Each team managed a post-partum simulation, which was recorded and reviewed by assessors. Primary outcome measures to assess teams NTS were the validated Global Assessment of Obstetric Team Performance (GAOTP) and Clinical Teamwork Scale (CTS). Secondary outcome measures were the 'friends and family test', technical skills, and the System Usability Scale (SUS). Sample size estimation was calculated by using 80% power 5% significance two tailed test (p1=85% p2=40%) n=34. 38 teams from August 2014-February 2016, were recruited, technical issues with failure of recording equipment meant 4 teams were excluded from teamwork analysis (1 intervention 3 control). Teamwork improved across all domains with the intervention (using a decision support mobile digital platform) p teamwork by 25% using CTS and 22% using GAOTP. Fewer technical skills were missed with the intervention (pteamwork is often cited as the cause of failures in care and we report a usable technology that assists with and improves teamwork during an emergency. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Piracetam for Aphasia in Post-stroke Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Zhang, Jie; Wei, Ruili; Chen, Zhongqin; Luo, Benyan

    2016-07-01

    Aphasia is a common symptom in post-stroke patients. Piracetam is a commonly used nootropic agent that promises various benefits to brain function, including language improvement. We performed a systematic review and meta-analysis to assess whether piracetam facilitates the rehabilitation of language performance in post-stroke patients. Randomized controlled trials (RCTs) of piracetam treatment in post-stroke patients published in any language were included, excluding those involving pre-existing cognitive disorders such as dementia and mood disturbances. We searched several databases including PubMed, EMBASE, Cochrane Central, CINAHL, Web of Science, and PsycINFO for RCTs published up to 31 December 2015. We conducted a meta-analysis using RevMan (version 5.3), with standardized mean differences (SMDs) and fixed-effect models, and used StataSE (version 13) for the detection of publication bias. This study has been submitted to PROSPERO, and its registration number is CRD42016034088. We identified 1180 titles and abstracts, and finally included seven RCTs in this meta-analysis. The number of participants in each study ranged from 19 to 66, summing up to 261 patients overall. The dose of piracetam was consistent while the frequency and time of therapy varied. The assessment of the language at the end of trials showed no significant improvement in overall severity of aphasia [SMD 0.23, 95 % confidence interval (CI) -0.03 to 0.49, P = 0.08], but written language (SMD 0.35, 95 % CI 0.04 to 0.66, P = 0.03) showed pronounced improvement. Subgroup analyses indicated a dissociation of effectiveness between short- and long-term assessment in overall severity (P = 0.008, I (2) = 85.6 %) in terms of tests for subgroup differences, and a mild trend toward dissociation in written subtests (P = 0.30, I (2) = 5.1 %). Funnel plots and Egger's test identified no obvious publication bias in the primary variable. Piracetam plays a limited role in the rehabilitation of

  3. Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

    Science.gov (United States)

    Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

    2016-12-01

    Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P grid laser treatment was performed for DME, the only participants to have a substantial reduction in mean CST between 1 and 2 years were those with a baseline VA of 20/50 or worse receiving bevacizumab and laser treatment (mean [SD], -55 [108] µm; 95% CI, -82 to -28 µm; P grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years

  4. [Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

    Science.gov (United States)

    Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

    2012-03-01

    Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

  5. Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Tikuišis, R; Miliauskas, P; Samalavičius, N E; Žurauskas, A; Samalavičius, R; Zabulis, V

    2014-04-01

    Perioperative intravenous (IV) infusion of lidocaine has been shown to decrease post-operative pain, shorten time to return of bowel function, and reduce the length of hospital stay. This randomized, prospective, double-blinded, placebo-controlled clinical trial evaluated the impact of IV lidocaine on the quality of post-operative analgesia and other outcomes after hand-assisted laparoscopic colon surgery. Sixty four patients with colon cancer scheduled for elective colon resection were involved in this study. Patients were randomized to receive either lidocaine infusion [lidocaine group (LG)] or normal 0.9 % saline infusion [placebo group (PG)] for a period of 24 h. Anaesthetic and surgical techniques were standardized. Twenty-four-hour post-operative analgesia in the recovery area was maintained by continuous infusion of 0.1 μg/kg/h fentanyl. The primary outcome of the study was post-operative pain control. Pain was assessed using visual analogue scale (VAS) scores at 2, 4, 8, 12, and 24 h after surgery. Patients with a VAS score >3 were treated with ketorolac 30 mg as needed. Secondary outcomes included time to resumption of bowel function and length of hospital stay. Data in the two groups were compared using the two-tailed Student's t test. All statistical tests were two-tailed at a significance level of 0.05. Demographic characteristics and clinical features of both groups were similar. Intensity of pain at rest in LG compared with PG was significantly lower during the first 24 h post-operatively. LG patients reported significantly less pain during movements at 2-, 12-, and 24-h post-surgery than PG patients. The study showed that ketorolac consumption was significantly higher in PG: mean ketorolac consumption in LG was 43.77 ± 13.86 mg and in PG 51.67 ± 13.16 mg (p = 0.047). Compared with placebo, lidocaine infusion produced a 32 % reduction in time to the first drink (Cohen's d = 3.85), 16 % reduction in time to the first full diet

  6. Clinical feasibility of the Nintendo Wii™ for balance training post-stroke: a phase II randomized controlled trial in an inpatient setting.

    Science.gov (United States)

    Bower, Kelly J; Clark, Ross A; McGinley, Jennifer L; Martin, Clarissa L; Miller, Kimberly J

    2014-09-01

    To investigate the feasibility and potential efficacy of the Nintendo Wii™ for balance rehabilitation after stroke. Phase II, single-blind, randomized controlled trial. Inpatient rehabilitation facility. Thirty adults (mean age 63.6 (14.7) years) undergoing inpatient rehabilitation who were less than three months post-stroke and able to stand unsupported. Participants were allocated to a Balance Group, using the 'Wii Fit Plus' in standing, or Upper Limb Group, using the 'Wii Sports/Sports Resort' in sitting. Both groups undertook three 45 minute sessions per week over two to four weeks in addition to standard care. The primary focus was feasibility, addressed by recruitment, retention, adherence, acceptability and safety. Efficacy was evaluated by balance, mobility and upper limb outcomes. Twenty-one percent of individuals screened were recruited and 86% (n = 30) of eligible people agreed to participate. Study retention and session adherence was 90% and > 99%, respectively, at two weeks; dropping to 70% and 87% at four weeks due to early discharge. All participants reported enjoying the sessions and most felt they were beneficial. No major adverse events occurred. Wii use by the Balance Group was associated with trends for improved balance, with significantly greater improvement in outcomes including the Step Test and Wii Balance Board-derived centre of pressure scores. The Upper Limb Group had larger, non-significant changes in arm function. A Wii-based approach appears feasible and promising for post-stroke balance rehabilitation. A larger randomized controlled trial is recommended to further investigate efficacy. © The Author(s) 2014.

  7. The efficacy of different pre- and post-operative analgesics in the management of pain after orthodontic separator placement: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    V Sudhakar

    2014-01-01

    Full Text Available Introduction: Pain-free treatment to the patients is considered as an important treatment objective for orthodontic health care providers. However, many orthodontists underestimate the degree of pain experienced by the patients. Hence, this study was conducted as a randomized, double-blinded clinical trial with the following objectives. Objective: To study the pain characteristics after separator placement; to compare the efficacy of various commonly used analgesics in pain management and to determine the efficacy of pre- and post-operative analgesics in pain management. Subjects and Methods: Data were collected from 154 patients (77 males and 77 females, age group of 14-21 years, with mean age of 18.8 years who reported to Department of Orthodontics. Patients were randomly divided in to four groups. Group 1: Paracetamol 650 mg, Group 2: Ibuprofen 400 mg, Group 3: Aspirin 300 mg, Group 4: Placebo and the study were conducted as a randomized, double-blinded clinical trial. The patients were instructed to take two tablets, one tablet 1 h before separator placement, and the other one after 6 h. The pain evaluations were made by the patients, when teeth not touching (TNT, biting back teeth together, chewing food (CF using a 100-mm visual analogue scale for 7 days after separator placement. Patients were advised to record the severity of pain. Results: Group 3 (Aspirin 300 mg showed lowest pain values, followed by Group 2 (ibuprofen 400 mg, and Group 1 (paracetamol 650 mg. All NSAID′s achieved good pain control compared to Group 4 (placebo, where the intensity pain was maximum. Conclusion: Pre- and post-operative analgesics were found to be more effective in controlling orthodontic pain, after separator placement at all-time intervals.

  8. Pressure and pain In Systemic sclerosis/Scleroderma - an evaluation of a simple intervention (PISCES: randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Alcacer-Pitarch Begonya

    2012-02-01

    Full Text Available Abstract Background Foot problems associated with Systemic Sclerosis (SSc/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122

  9. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial.

    Science.gov (United States)

    Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith A Y; Silburn, Sven

    2010-10-21

    This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. ISRCTN24952438.

  10. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

    DEFF Research Database (Denmark)

    Punthakee, Z; Bosch, J; Dagenais, G

    2012-01-01

    AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...

  11. The effect of intravenous dextrose administration for prevention of post-operative nausea and vomiting after laparoscopic cholecystectomy: A double-blind, randomised controlled trial.

    Science.gov (United States)

    Firouzian, Abolfazl; Kiasari, Alieh Zamani; Godazandeh, Gholamali; Baradari, Afshin Gholipour; Alipour, Abbas; Taheri, Arman; Emami Zeydi, Amir; Montazemi, Maryam

    2017-10-01

    Post-operative nausea and vomiting (PONV) is a common and distressing complication after laparoscopic cholecystectomy (LC). The aim of this study was to evaluate the effect of intravenous (IV) dextrose administration for the prophylaxis of PONV after LC. In a double-blind, randomised controlled trial, a total of 150 female patients who were scheduled for elective LC were randomly assigned into two groups (A and B). Thirty minutes before induction of anaesthesia, patients received an infusion of 500 cc lactated Ringer's solution (Group A) and 5% dextrose in lactated Ringer's solution (Group B) and over a period of 30 min. All patients rated their nausea and vomiting intensity using the verbal rating scale immediately at post-anaesthesia care unit (PACU) arrival; 30, 60, 90 and 120 min after arriving at the PACU and 6, 12 and 24 h after surgery. There was a statistically significant time trend and group effect along with significant differences in time/group interaction effect in both groups for nausea and vomiting scores ( P Dextrose administration reduced the odds of vomiting events compared to placebo (estimate: -0.87, odds ratio = 0.42, 95% confidence interval: 0.28-0.64). Administration of IV dextrose before anaesthesia induction may be recommended as an effective, and safe method for the prophylaxis of PONV after LC.

  12. Post-discharge management following hip fracture - get you back to B4: A parallel group, randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Brown Roy A

    2011-06-01

    Full Text Available Abstract Background Fall-related hip fractures result in significant personal and societal consequences; importantly, up to half of older adults with hip fracture never regain their previous level of mobility. Strategies of follow-up care for older adults after fracture have improved investigation for osteoporosis; but managing bone health alone is not enough. Prevention of fractures requires management of both bone health and falls risk factors (including the contributing role of cognition, balance and continence to improve outcomes. Methods/Design This is a parallel group, pragmatic randomized controlled trial to test the effectiveness of a post-fracture clinic compared with usual care on mobility for older adults following their hospitalization for hip fracture. Participants randomized to the intervention will attend a fracture follow-up clinic where a geriatrician and physiotherapist will assess and manage their mobility and other health issues. Depending on needs identified at the clinical assessment, participants may receive individualized and group-based outpatient physiotherapy, and a home exercise program. Our primary objective is to assess the effectiveness of a novel post-discharge fracture management strategy on the mobility of older adults after hip fracture. We will enrol 130 older adults (65 years+ who have sustained a hip fracture in the previous three months, and were admitted to hospital from home and are expected to be discharged home. We will exclude older adults who prior to the fracture were: unable to walk 10 meters; diagnosed with dementia and/or significant comorbidities that would preclude their participation in the clinical service. Eligible participants will be randomly assigned to the Intervention or Usual Care groups by remote allocation. Treatment allocation will be concealed; investigators, measurement team and primary data analysts will be blinded to group allocation. Our primary outcome is mobility

  13. Evidence-based intervention against bullying and cyberbullying: Evaluation of the NoTrap! program in two independent trials.

    Science.gov (United States)

    Palladino, Benedetta E; Nocentini, Annalaura; Menesini, Ersilia

    2016-01-01

    The NoTrap! (Noncadiamointrappola!) program is a school-based intervention, which utilizes a peer-led approach to prevent and combat both traditional bullying and cyberbullying. The aim of the present study was to evaluate the efficacy of the third Edition of the program in accordance with the recent criteria for evidence-based interventions. Towards this aim, two quasi-experimental trials involving adolescents (age M = 14.91, SD = .98) attending their first year at different high schools were conducted. In Trial 1 (control group, n = 171; experimental group, n = 451), latent growth curve models for data from pre-, middle- and post-tests showed that intervention significantly predicted change over time in all the target variables (victimization, bullying, cybervictimization, and cyberbullying). Specifically, target variables were stable for the control group but decreased significantly over time for the experimental group. Long-term effects at the follow up 6 months later were also found. In Trial 2 (control group, n = 227; experimental group, n = 234), the moderating effect of gender was examined and there was a reported decrease in bullying and cyberbullying over time (pre- and post-test) in the experimental group but not the control group, and this decrease was similar for boys and girls. © 2016 Wiley Periodicals, Inc.

  14. [Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

    2014-09-01

    Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

  15. Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial.

    Science.gov (United States)

    Matthews, Paul A; Scammell, Brigitte E; Ali, Arfan; Coughlin, Timothy; Nightingale, Jessica; Khan, Tanvir; Ollivere, Ben J

    2018-05-31

    Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks' immobilisation in a below-knee cast. We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included. The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external

  16. Using the TED Talks to Evaluate Spoken Post-editing of Machine Translation

    DEFF Research Database (Denmark)

    Liyanapathirana, Jeevanthi; Popescu-Belis, Andrei

    2016-01-01

    This paper presents a solution to evaluate spoken post-editing of imperfect machine translation output by a human translator. We compare two approaches to the combination of machine translation (MT) and automatic speech recognition (ASR): a heuristic algorithm and a machine learning method...

  17. Pre-liver transplant psychosocial evaluation predicts post-transplantation outcomes.

    Science.gov (United States)

    Benson, Ariel A; Rowe, Mina; Eid, Ahmad; Bluth, Keren; Merhav, Hadar; Khalaileh, Abed; Safadi, Rifaat

    2018-08-01

    Psychosocial factors greatly impact the course of patients throughout the liver transplantation process. A retrospective chart review was performed of patients who underwent liver transplantation at Hadassah-Hebrew University Medical Center between 2002 and 2012. A composite psychosocial score was computed based on the patient's pre-transplant evaluation. Patients were divided into two groups based on compliance, support and insight: Optimal psychosocial score and Non-optimal psychosocial score. Post-liver transplantation survival and complication rates were evaluated. Out of 100 patients who underwent liver transplantation at the Hadassah-Hebrew University Medical Center between 2002 and 2012, 93% had a complete pre-liver transplant psychosocial evaluation in the medical record performed by professional psychologists and social workers. Post-liver transplantation survival was significantly higher in the Optimal group (85%) as compared to the Non-optimal group (56%, p = .002). Post-liver transplantation rate of renal failure was significantly lower in the Optimal group. No significant differences were observed between the groups in other post-transplant complications. A patient's psychosocial status may impact outcomes following transplantation as inferior psychosocial grades were associated with lower overall survival and increased rates of complications. Pre-liver transplant psychosocial evaluations are an important tool to help predict survival following transplantation.

  18. The development of a post occupancy evaluation tool for primary schools: learner comfort assessment tool (LCAT)

    CSIR Research Space (South Africa)

    Motsatsi, L

    2015-12-01

    Full Text Available in order to facilitate teaching and learning. The aim of this study was to develop a Post Occupational Evaluation (POE) tool to assess learner comfort in relation to indoor environmental quality in the classroom. The development of POE tool followed a...

  19. Reducing child abuse amongst adolescents in low- and middle-income countries: A pre-post trial in South Africa

    Directory of Open Access Journals (Sweden)

    Lucie Cluver

    2016-07-01

    Full Text Available Abstract Background No known studies have tested the effectiveness of child abuse prevention programmes for adolescents in low- or middle-income countries. ‘Parenting for Lifelong Health’ ( http://tiny.cc/whoPLH is a collaborative project to develop and rigorously test abuse-prevention parenting programmes for free use in low-resource contexts. Research aims of this first pre-post trial in South Africa were: i to identify indicative effects of the programme on child abuse and related outcomes; ii to investigate programme safety for testing in a future randomised trial, and iii to identify potential adaptations. Methods Two hundred thirty participants (adolescents and their primary caregivers were recruited from schools, welfare services and community-sampling in rural, high-poverty South Africa (no exclusion criteria. All participated in a 12-week parenting programme, implemented by local NGO childcare workers to ensure real-world external validity. Standardised pre-post measures with adolescents and caregivers were used, and paired t-tests were conducted for primary outcomes: abuse (physical, emotional abuse and neglect, adolescent behaviour problems and parenting (positive and involved parenting, poor monitoring and inconsistent discipline, and secondary outcomes: mental health, social support and substance use. Results Participants reported high levels of socio-economic deprivation, e.g. 60 % of adolescents had either an HIV-positive caregiver or were orphaned by AIDS, and 50 % of caregivers experienced intimate partner violence. i indicative effects: Primary outcomes comparing pre-test and post-test assessments showed reductions reported by adolescents and caregivers in child abuse (adolescent report 63.0 % pre-test to 29.5 % post-test, caregiver report 75.5 % pre-test to 36.5 % post-test, both p < 0.001 poor monitoring/inconsistent discipline (p < .001, adolescent delinquency/aggressive behaviour (both p < .001, and

  20. A process evaluation of the Supermarket Healthy Eating for Life (SHELf) randomized controlled trial.

    Science.gov (United States)

    Olstad, Dana Lee; Ball, Kylie; Abbott, Gavin; McNaughton, Sarah A; Le, Ha N D; Ni Mhurchu, Cliona; Pollard, Christina; Crawford, David A

    2016-02-24

    Supermarket Healthy Eating for Life (SHELf) was a randomized controlled trial that operationalized a socioecological approach to population-level dietary behaviour change in a real-world supermarket setting. SHELf tested the impact of individual (skill-building), environmental (20% price reductions), and combined (skill-building + 20% price reductions) interventions on women's purchasing and consumption of fruits, vegetables, low-calorie carbonated beverages and water. This process evaluation investigated the reach, effectiveness, implementation, and maintenance of the SHELf interventions. RE-AIM provided a conceptual framework to examine the processes underlying the impact of the interventions using data from participant surveys and objective sales data collected at baseline, post-intervention (3 months) and 6-months post-intervention. Fisher's exact, χ (2) and t-tests assessed differences in quantitative survey responses among groups. Adjusted linear regression examined the impact of self-reported intervention dose on food purchasing and consumption outcomes. Thematic analysis identified key themes within qualitative survey responses. Reach of the SHELf interventions to disadvantaged groups, and beyond study participants themselves, was moderate. Just over one-third of intervention participants indicated that the interventions were effective in changing the way they bought, cooked or consumed food (p < 0.001 compared to control), with no differences among intervention groups. Improvements in purchasing and consumption outcomes were greatest among those who received a higher intervention dose. Most notably, participants who said they accessed price reductions on fruits and vegetables purchased (519 g/week) and consumed (0.5 servings/day) more vegetables. The majority of participants said they accessed (82%) and appreciated discounts on fruits and vegetables, while there was limited use (40%) and appreciation of discounts on low-calorie carbonated

  1. Efficacy of interpersonal therapy-group format adapted to post-traumatic stress disorder: an open-label add-on trial.

    Science.gov (United States)

    Campanini, Rosaly F B; Schoedl, Aline F; Pupo, Mariana C; Costa, Ana Clara H; Krupnick, Janice L; Mello, Marcelo F

    2010-01-01

    Post-traumatic stress disorder (PTSD) is a highly prevalent condition, yet available treatments demonstrate only modest efficacy. Exposure therapies, considered by many to be the "gold-standard" therapy for PTSD, are poorly tolerated by many patients and show high attrition. We evaluated interpersonal therapy, in a group format, adapted to PTSD (IPT-G PTSD), as an adjunctive treatment for patients who failed to respond to conventional psychopharmacological treatment. Research participants included 40 patients who sought treatment through a program on violence in the department of psychiatry of Federal University of São Paulo (UNIFESP). They had received conventional psychopharmacological treatment for at least 12 weeks and failed to have an adequate clinical response. After signing an informed consent, approved earlier by the UNIFESP Ethics Review Board, they received a semi-structured diagnostic interview (SCID-I), administered by a trained mental health worker, to confirm the presence of a PTSD diagnosis according to DSM-IV criteria. Other instruments were administered, and patients completed out self-report instruments at baseline, and endpoint to evaluate clinical outcomes. Thirty-three patients completed the trial, but all had at least one second outcome evaluation. There were significant improvements on all measures, with large effect sizes. IPT-G PTSD was effective not only in decreasing symptoms of PTSD, but also in decreasing symptoms of anxiety and depression. It led to significant improvements in social adjustment and quality of life. It was well tolerated and there were few dropouts. Our results are very preliminary; they need further confirmation through randomized controlled clinical trials.

  2. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

    International Nuclear Information System (INIS)

    Endrikat, J.; Schwenke, C.; Prince, M.R.

    2015-01-01

    Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

  3. Pre- and Post-Trial Equality in Criminal Justice in the Context of the Separation of Powers

    Directory of Open Access Journals (Sweden)

    L Wolf

    2011-08-01

    Full Text Available The previous Westminster criminal justice system entailed a different kind of separation of powers insofar as it concerns the role of state prosecutors. In the Westminster system prosecutors are part of the executive branch, whereas they were a split-off from the judiciary in constitutional states and function like a de facto second organ of the third branch of state power. Currently executive interference in state prosecutions often leads to pre-trial inequality. A further difficulty arises from the unconsidered manner in which the former royal prerogative of pardoning was retained in the Constitution of the Republic of South Africa, 1996. It used to be a royal veto of judicial sentences in the constitutional monarchy of the former Westminster model. Although the corresponding veto of parliamentary legislation by the head of state did not survive into modern times, the pardoning power has not been discontinued. Section 84(2(j thus causes an irreconcilable conflict with section 165(5 of the Constitution which guarantees the legally binding force of judicial decisions. It undermines the rule of law and leads to post-trial inequality in the execution of sentences. The parole system, which dates back to 1959, likewise allows the executive to overrule judicial sentences and is in conflict with section 165(5. The perpetuation of the status quo in criminal justice is in effect leading to a re-Westminstering of the constitutional state.

  4. Group Cognitive-Behavior Therapy and Supportive Art and Sport Interventions on Bam Earthquake Related Post Traumatic Stress Symptoms in Children: A Field Trial

    Directory of Open Access Journals (Sweden)

    Narges Joshaghani

    2009-12-01

    Full Text Available "n Objective: "n "nThe main objective of this study is to evaluate the effect of psychological therapies and art/sport supportive interventions separately,and in combination on post traumatic stress symptoms in children and compare them with a control group . "nMethods: In a field trial, we evaluated the efficacy of group behavioral therapy, art and sport supportive interventions in Bam earthquake children survivors with PTSD symptoms and compared it with a control group. Before and after interventions we evaluated the PTSD symptoms using K-SADS-PL semi-structural interview for each group and compared them using appropriate statistical methods. "nResults: The participants were 200 individuals who were randomized in four groups according to an intervention program including: Group behavioral therapy; Group behavioral therapy plus art and sport interventions; Art and sport interventions; and control group. During the interventions, 39 individuals were excluded. None of the participants had severed PTSD or other psychiatry disorders that needed pharmacological interventions. In interventional groups, the reduction of total PTSD symptoms and the symptoms of re-experience, avoidance and hyper arousal was not statistically significant. However, in the control group, the PTSD symptoms increased during the study which was statistically significant. "nConclusion: Group behavior therapy and supportive interventions (art and sport may have preventive effects on PTSD symptoms.

  5. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Davenport, Todd E; Kulig, Kornelia; Fisher, Beth E

    2010-10-19

    Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM) is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. http://www.clinicaltrials.gov identifier NCT00888498.

  6. COMPARISON BETWEEN POST ISOMETRIC RELAXATION AND RECIPROCAL INHIBITION MANUEVERS ON HAMSTRING FLEXIBILITY IN YOUNG HEALTHY ADULTS: RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    Agrawal Sonal S

    2016-01-01

    Full Text Available Background & Purpose: Variations in the application of muscle energy technique (MET for increasing the extensibility of muscles have been advocated, but little evidence exists to support the relative merit of a particular approach. This study investigated two types of muscle energy techniques that have been advocated in the osteopathic literature that differ primarily in the muscle group targeted. Aim: To compare the efficacy of Post Isometric Relaxation (PIR and Reciprocal Inhibition (RI on hamstring length in young healthy adults Methodology: Randomized clinical trial 100 college students aged between 18-25 years were included. The subjects were randomly assigned to PIR and RI group. Each group consisted of 50 subjects (25 male, 25 female. Knee extension limitation was measured by using active knee extension test (AKET pre & post-intervention, i.e. after 3 weeks of stretching regimen, with the help of universal full circle goniometer. Results: There was significant improvement in hamstrings flexibility (p=0.000 in both PIR and RI groups. Statistical comparison of the results of both the technique showed that PIR group had greater improvement than the RI group (p=0.000 Conclusion: PIR and RI were both found to be effective in improving hamstring flexibility but, PIR is more effective therapeutic maneuver.

  7. Comparison of peritonsillar infiltration effects of ketamine and tramadol on post tonsillectomy pain: a double-blinded randomized placebo-controlled clinical trial

    Science.gov (United States)

    Ayatollahi, Vida; Behdad, Shekoufeh; Hatami, Maryam; Moshtaghiun, Hossein; Baghianimoghadam, Behnam

    2012-01-01

    Aim To assess the effect of peritonsillar infiltration of ketamine and tramadol on post tonsillectomy pain and compare the side effects. Methods The double-blind randomized clinical trial was performed on 126 patients aged 5-12 years who had been scheduled for elective tonsillectomy. The patients were randomly divided into 3 groups to receive either ketamine, tramadol, or placebo. They had American Society of Anesthesiologists physical status class I and II. All patients underwent the same method of anesthesia and surgical procedure. The three groups did not differ according to their age, sex, and duration of anesthesia and surgery. Post operative pain was evaluated using CHEOPS score. Other parameters such as the time to the first request for analgesic, hemodynamic elements, sedation score, nausea, vomiting, and hallucination were also assessed during 12 hours after surgery. Results Tramadol group had significantly lower pain scores (P = 0.005), significantly longer time to the first request for analgesic (P = 0.001), significantly shorter time to the beginning of liquid regimen (P = 0.001), and lower hemodynamic parameters such as blood pressure (P = 0.001) and heart rate (P = 0.001) than other two groups. Ketamine group had significantly greater presence of hallucinations and negative behavior than tramadol and placebo groups. The groups did not differ significantly in the presence of nausea and vomiting. Conclusion Preoperative peritonsillar infiltration of tramadol can decrease post-tonsillectomy pain, analgesic consumption, and the time to recovery without significant side effects. Registration No: IRCT201103255764N2 PMID:22522994

  8. Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

    Directory of Open Access Journals (Sweden)

    Alfredo D. Oliveira-Filho

    2014-12-01

    Full Text Available Background: Effective interventions to improve medication adherence are usually complex and expensive. Objective: To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD. Method: A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4. The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates. Results: 61 patients were randomized to intervention (n = 30 and control (n = 31 groups. The mean age of the patients was 61 years (SD 12.73, 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3. Medication adherence was correlated to intervention (p = 0.04 and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups. Conclusion: The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes.

  9. Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Palmer, Rebecca; Cooper, Cindy; Enderby, Pam; Brady, Marian; Julious, Steven; Bowen, Audrey; Latimer, Nicholas

    2015-01-27

    Aphasia affects the ability to speak, comprehend spoken language, read and write. One third of stroke survivors experience aphasia. Evidence suggests that aphasia can continue to improve after the first few months with intensive speech and language therapy, which is frequently beyond what resources allow. The development of computer software for language practice provides an opportunity for self-managed therapy. This pragmatic randomised controlled trial will investigate the clinical and cost effectiveness of a computerised approach to long-term aphasia therapy post stroke. A total of 285 adults with aphasia at least four months post stroke will be randomly allocated to either usual care, computerised intervention in addition to usual care or attention and activity control in addition to usual care. Those in the intervention group will receive six months of self-managed word finding practice on their home computer with monthly face-to-face support from a volunteer/assistant. Those in the attention control group will receive puzzle activities, supplemented by monthly telephone calls. Study delivery will be coordinated by 20 speech and language therapy departments across the United Kingdom. Outcome measures will be made at baseline, six, nine and 12 months after randomisation by blinded speech and language therapist assessors. Primary outcomes are the change in number of words (of personal relevance) named correctly at six months and improvement in functional conversation. Primary outcomes will be analysed using a Hochberg testing procedure. Significance will be declared if differences in both word retrieval and functional conversation at six months are significant at the 5% level, or if either comparison is significant at 2.5%. A cost utility analysis will be undertaken from the NHS and personal social service perspective. Differences between costs and quality-adjusted life years in the three groups will be described and the incremental cost effectiveness ratio

  10. Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mansfield, Avril; Aqui, Anthony; Centen, Andrew; Danells, Cynthia J; DePaul, Vincent G; Knorr, Svetlana; Schinkel-Ivy, Alison; Brooks, Dina; Inness, Elizabeth L; McIlroy, William E; Mochizuki, George

    2015-06-06

    Falls are one of the most common medical complications post-stroke. Physical exercise, particularly exercise that challenges balance, reduces the risk of falls among healthy and frail older adults. However, exercise has not proven effective for preventing falls post-stroke. Falls ultimately occur when an individual fails to recover from a loss of balance. Thus, training to specifically improve reactive balance control could prevent falls. Perturbation training aims to improve reactive balance control by repeatedly exposing participants to postural perturbations. There is emerging evidence that perturbation training reduces fall rates among individuals with neurological conditions, such as Parkinson disease. The primary aim of this work is to determine if perturbation-based balance training can reduce occurrence of falls in daily life among individuals with chronic stroke. Secondary objectives are to determine the effect of perturbation training on balance confidence and activity restriction, and functional balance and mobility. Individuals with chronic stroke will be recruited. Participants will be randomly assigned to one of two groups: 1) perturbation training, or 2) 'traditional' balance training. Perturbation training will involve both manual perturbations (e.g., a push or pull from a physiotherapist), and rapid voluntary movements to cause a loss of balance. Training will occur twice per week for 6 weeks. Participants will record falls and activity for 12 months following completion of the training program. Standardized clinical tools will be used to assess functional balance and mobility, and balance confidence before and after training. Falls are a significant problem for those with stroke. Despite the large body of work demonstrating effective interventions, such as exercise, for preventing falls in other populations, there is little evidence for interventions that prevent falls post-stroke. The proposed study will investigate a novel and promising

  11. Effectiveness of a facebook-delivered physical activity intervention for post-partum women: a randomized controlled trial protocol.

    Science.gov (United States)

    Kernot, Jocelyn; Olds, Tim; Lewis, Lucy K; Maher, Carol

    2013-05-29

    Physical activity is reduced during the post-partum period. Facebook is frequently used by Australian mothers, and offers flexibility, high levels of engagement and the ability to disseminate information and advice via social contacts. The Mums Step it Up Program is a newly developed 50 day team-based physical activity intervention delivered via a Facebook app. The program involves post-partum women working in teams of 4-8 friends aiming to achieve 10,000 steps per day measured by a pedometer. Women are encouraged to use the app to log their daily steps and undertake social and supportive interactions with their friends and other participants. This study aims to determine the effectiveness of the Mums Step it Up Program. A sample of 126 women up to 12 months post-partum will be recruited through community-based health and family services. Participants will be randomly allocated into one of three groups: control, pedometer only and the Mums Step it Up Program. Assessments will be completed at baseline, 6 weeks and 6 months. The primary outcome (objective physical activity) and the secondary outcomes (sleep quality and quantity, depressive symptoms, weight and quality of life) will be used to determine the effectiveness of the Mums Step it Up Program compared with the control and pedometer only groups. Analyses will be undertaken on an intention-to-treat-basis using random effects mixed modeling. The effect of theorized mediators (physical activity attitudes, subjective norms and perceived behavioral control) will also be examined. This study will provide information about the potential of a Facebook app for the delivery of health behavior interventions. If this intervention proves to be effective it will be released on a mass scale and promoted to the general public. Australia and New Zealand Clinical Trials Register: ACTRN12613000069752.

  12. A qualitative synthesis of trials promoting physical activity behaviour change among post-treatment breast cancer survivors.

    Science.gov (United States)

    Short, Camille E; James, Erica L; Stacey, Fiona; Plotnikoff, Ronald C

    2013-12-01

    Health outcome trials have provided strong evidence that participating in regular physical activity can improve the quality of life and health of post-treatment breast cancer survivors. Focus is now needed on how to promote changes in physical activity behaviour among this group. This systematic review examines the efficacy of behavioural interventions for promoting physical activity among post-treatment breast cancer survivors. Behavioural intervention studies published up until July 2012 were identified through a systematic search of two databases: MEDLINE and CINAHL, and by searching reference lists of relevant publications and scanning citation libraries of project staff. Eight out of the ten identified studies reported positive intervention effects on aerobic physical activity behaviour, ranging from during the intervention period to 6 months post-intervention. Only two studies reported intervention effect sizes. The identification of factors related to efficacy was not possible because of the limited number and heterogeneity of studies included, as well as the lack of effect sizes reported. Nonetheless, an examination of the eight studies that did yield significant intervention effects suggests that 12-week interventions employing behaviour change techniques (e.g., self-monitoring and goal setting) derived from a variety of theories and delivered in a variety of settings (i.e., one-on-one, group or home) can be effective at changing the aerobic physical activity behaviour of breast cancer survivors in the mid- to long terms. Behavioural interventions do hold promise for effectively changing physical activity behaviour among breast cancer survivors. However, future research is needed to address the lack of studies exploring long-term intervention effects, mediators of intervention effects and interventions promoting resistance-training activity, and to address issues impacting on validity, such as the limited use of objective physical activity measures and

  13. Randomized Controlled Evaluation of an Early Intervention to Prevent Post-Rape Psychopathology

    OpenAIRE

    Resnick, Heidi; Acierno, Ron; Waldrop, Angela E.; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J.; Kilpatrick, Dean

    2007-01-01

    A randomized between-group design was used to evaluate efficacy of a video intervention to reduce PTSD and other mental health problems, implemented prior to the forensic medical exam conducted within 72 hours post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) ages 15 or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and de...

  14. Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

    Science.gov (United States)

    Panda, Anita; Prakash, Vadivelu Jaya; Dada, Tanuj; Gupta, Anoop Kishore; Khokhar, Sudarshan; Vanathi, Murugesan

    2011-01-01

    Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV) in post-penetrating-keratoplasty glaucoma (PKPG). Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP) >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7) implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5 glaucoma managed by AGV implantation revealed a satisfactory outcome up to 6 months of follow-up. PMID:21586837

  15. The radiological evaluation of a prototype posting-in hatch under conditions of high alpha activity

    International Nuclear Information System (INIS)

    Smith, D.I.; Hollick, R.C.

    1987-07-01

    A prototype posting-in hatch, mounted vertically in the top panel of a highly active glovebox has been radiologically evaluated in the Fuels Laboratory, AEEW. This simple, air-lock type system of 100 mm diameter has pneumatically operated and interlocked lids and a low velocity, inward purge, supplied by the glovebox depression. The hatch proved extremely reliable and very easy to operate. More than 1200 simulated posting movements were carried out and a > 8 order of magnitude reduction in aerosol concentration was recorded from the active glovebox to the monitoring environment. (author)

  16. Evaluating the design and reporting of pragmatic trials in osteoarthritis research.

    Science.gov (United States)

    Ali, Shabana Amanda; Kloseck, Marita; Lee, Karen; Walsh, Kathleen Ellen; MacDermid, Joy C; Fitzsimmons, Deborah

    2018-01-01

    Among the challenges in health research is translating interventions from controlled experimental settings to clinical and community settings where chronic disease is managed daily. Pragmatic trials offer a method for testing interventions in real-world settings but are seldom used in OA research. The aim of this study was to evaluate the literature on pragmatic trials in OA research up to August 2016 in order to identify strengths and weaknesses in the design and reporting of these trials. We used established guidelines to assess the degree to which 61 OA studies complied with pragmatic trial design and reporting. We assessed design according to the pragmatic-explanatory continuum indicator summary and reporting according to the pragmatic trials extension of the CONsolidated Standards of Reporting Trials guidelines. None of the pragmatic trials met all 11 criteria evaluated and most of the trials met between 5 and 8 of the criteria. Criteria most often unmet pertained to practitioner expertise (by requiring specialists) and criteria most often met pertained to primary outcome analysis (by using intention-to-treat analysis). Our results suggest a lack of highly pragmatic trials in OA research. We identify this as a point of opportunity to improve research translation, since optimizing the design and reporting of pragmatic trials can facilitate implementation of evidence-based interventions for OA care. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  17. Pre- and post-operative evaluations of eight dogs following right nephrectomy due to Dioctophyma renale.

    Science.gov (United States)

    Mesquita, L R; Rahal, S C; Faria, L G; Takahira, R K; Rocha, N S; Mamprim, M J; Oliveira, H S

    2014-01-01

    Dioctophyma renale is a large nematode distributed worldwide that may cause progressive and severe destruction of renal parenchyma. The present study aimed to evaluate pre- and post-operatively dogs submitted to right nephrectomy due to D. renale and to assess the histopathological damage of the removed kidney. Eight crossbred dogs, aged from 12 to 48 months that were unilaterally nephrectomized due to the presence of D. renale were evaluated. Physical examination, urinalysis, complete blood count, serum biochemistry, and abdominal ultrasound were performed immediately before and one month after nephrectomy. The nephrectomized right kidneys were submitted to macroscopic and microscopic evaluations. Urinalysis preoperatively detected occult blood in all dogs and D. renale eggs in five cases. Complete blood count showed all parameters within the reference range, except one dog post-operatively. Serum biochemistry performed before and after surgery verified that urea, creatinine and sodium were within the reference range values in all dogs. Other findings varied among the dogs. The length and arterial resistive index mean values of the left kidney were similar pre- and post-operatively. Thus, the inconsiderable change in laboratory findings pre- and post-operatively was attributable to compensation by left kidney function for the removed abnormal right kidney. Right kidney histology revealed chronic nephropathy due to D. renale. Imaging diagnosis should be performed on dogs suspected as carrying the disease or on those from an enzootic area since the laboratory findings are not specific except eggs in the urine.

  18. A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder.

    Science.gov (United States)

    McGovern, Mark P; Lambert-Harris, Chantal; Xie, Haiyi; Meier, Andrea; McLeman, Bethany; Saunders, Elizabeth

    2015-07-01

    Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms. Three-group, multi-site randomized controlled trial. Seven addiction treatment programs in Vermont and New Hampshire, USA. Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management. Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention. PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI =

  19. Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE: a randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Winstein Carolee J

    2013-01-01

    Full Text Available Abstract Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP, compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC. Two secondary objectives are to compare ASAP to a true (active monitoring only usual and customary (UCC therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary

  20. Post-evaluation of the neurophaties treatment post-trauma with therapeutic laser. Model in sciatic nerve of frog

    Science.gov (United States)

    Escobar, Antonio S.; Ocampo, Arcelia F. M.; Hernández, María G. H.; Jasso, José L. C.; Lira, Maricela O. F.; Flores, Mariana A.; Balderrama, Vicente L.

    2010-05-01

    The purpose of this study was to evaluate the compound nerve action potential amplitude and latency measured to determine the degree of myelination and the number of fibers stimulated in a model of stimulated frog sciatic nerve laser at 810 nm as perioperative treatment after injury. It used 30 bullfrogs (Rana catesbeiana) to obtain 60 sciatic nerves forming four groups, groups 1 and 2 worked with nerves in vitro, were dissected in humid chambers for placing isolated organ, was recorded on compound nerve action potential, the second group laser was applied at 24, 48, 72, 96 and 120 hours and at the same time were placed in 10% formalin. Groups 3 and 4 are worked in vivo localizing the nerve and causing damage through compression, occurred over the compound nerve action potential to assess the degree of myelination and the number of fibers stimulated, the group 4 was applied to 810 nm laser (500 Hz, 10 J, 200 mW) after injury, after 48 hours, three frogs were sacrificed by introducing the nerves in 10% formalin. The latency recorded by stimulating the sciatic nerve of frog to 0.5 mA and 100 ms in groups 1 and 2 show significant differences (p000), as to the extent, if any statistically significant difference. (pparesthesia (post-traumatic neuropathy).

  1. Post-evaluation of the neurophaties treatment post-trauma with therapeutic laser. Model in sciatic nerve of frog

    International Nuclear Information System (INIS)

    Escobar, Antonio S.; Ocampo, Arcelia F. M.; Hernandez, Maria G. H.; Jasso, Jose L. C.; Lira, Maricela O. F.; Flores, Mariana A.; Balderrama, Vicente L.

    2010-01-01

    The purpose of this study was to evaluate the compound nerve action potential amplitude and latency measured to determine the degree of myelination and the number of fibers stimulated in a model of stimulated frog sciatic nerve laser at 810 nm as perioperative treatment after injury. It used 30 bullfrogs (Rana catesbeiana) to obtain 60 sciatic nerves forming four groups, groups 1 and 2 worked with nerves in vitro, were dissected in humid chambers for placing isolated organ, was recorded on compound nerve action potential, the second group laser was applied at 24, 48, 72, 96 and 120 hours and at the same time were placed in 10% formalin. Groups 3 and 4 are worked in vivo localizing the nerve and causing damage through compression, occurred over the compound nerve action potential to assess the degree of myelination and the number of fibers stimulated, the group 4 was applied to 810 nm laser (500 Hz, 10 J, 200 mW) after injury, after 48 hours, three frogs were sacrificed by introducing the nerves in 10% formalin. The latency recorded by stimulating the sciatic nerve of frog to 0.5 mA and 100 ms in groups 1 and 2 show significant differences (p 000), as to the extent, if any statistically significant difference. (p<0.001 and p<0.000). The laser produces a favorable response in the treatment of paresthesia (post-traumatic neuropathy).

  2. [Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

    Science.gov (United States)

    Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

    2017-08-01

    As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels: optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects: mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

  3. The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial.

    Science.gov (United States)

    Shakur, Haleema; Roberts, Ian; Edwards, Philip; Elbourne, Diana; Alfirevic, Zarko; Ronsmans, Carine

    2016-05-17

    Severe haemorrhage is a leading cause of maternal death worldwide. Most haemorrhage deaths occur soon after childbirth. Severe post-partum bleeding is sometimes managed by the surgical removal of the uterus (hysterectomy). Death and hysterectomy are important health consequences of post-partum haemorrhage, and clinical trials of interventions aimed at preventing these outcomes are needed. The World Maternal Antifibrinolytic trial aims to determine the effect of tranexamic acid on death, hysterectomy and other health outcomes in women with post-partum haemorrhage. It is an international, multicentre, randomised trial. Approximately 20,000 women with post-partum haemorrhage will be randomly allocated to receive an intravenous injection of either tranexamic acid or matching placebo in addition to usual care. The primary outcome measure is a composite of death in hospital or hysterectomy within 42 days of delivery. The cause of death will be described. Secondary outcomes include death, death due to bleeding, hysterectomy, thromboembolic events, blood transfusion, surgical and radiological interventions, complications, adverse events and quality of life. The health status and occurrence of thromboembolic events in breastfed babies will also be reported. We will conduct subgroup analyses for the primary outcome by time to treatment, type of delivery and cause of haemorrhage. We will conduct an analysis of treatment effect adjusted for baseline risk. The World Maternal Antifibrinolytic trial should provide reliable evidence for the efficacy of tranexamic acid in the prevention of death, hysterectomy and other outcomes that are important to patients. We present a protocol update and the statistical analysis plan for the trial. Current Controlled Trials ISRCTN76912190 (Registration date 08 December 2008), Clinicaltrials.gov NCT00872469 (Registration date 30 March 2009) and Pan African Clinical Trials Registry: PACTR201007000192283 (Registration date 02 September 2010).

  4. Evaluation of carbohydrate restriction as primary treatment for post-gastric bypass hypoglycemia.

    Science.gov (United States)

    van Meijeren, Jorick; Timmer, Ilse; Brandts, Hans; Janssen, Ignace; Boer, Hans de

    2017-03-01

    Up to 15% of patients who have undergone Roux-en-Y gastric bypass (RYGB) surgery may eventually develop symptoms of hypoglycemia. To evaluate the daily life efficacy of a carbohydrate (carb)-restricted dietary advice (CRD) of 6 meals per day with a 30 g carb maximum per meal in patients with documented post-RYGB hypoglycemia. Teaching hospital, the Netherlands. Frequency and severity of hypoglycemic events before and after CRD were assessed retrospectively in 41 patients with documented post-RYGB hypoglycemia, based on medical records and telephone questionnaires. Hypoglycemia was defined as a blood glucose leveltreatment of hypoglycemia, decreased from 23 to 6 (Pmeals per day with up to 30 g carbs each, is an effective treatment of post-RYGB hypoglycemia in the majority of patients. Additional medication is needed in about a third of patients. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  5. BLIND TRIALS EVALUATING IN VITRO INFECTIVITY OF CRYPTOSPORIDIUM PARVUM OOCYSTS USING CELL CULTURE IMMUNOFLUORESCENCE

    Science.gov (United States)

    An optimized cell culture-immunofluorescence (IFA) procedure, using the HCT-8 cell line, was evaluated in 'blind' trials to determine the sensitivity and reproducibility for measuring infectivity of flow cytometry prepared inocula of C. parvum oocysts. In separate trials, suspens...

  6. Evaluation of the Utility of a Discrete-Trial Functional Analysis in Early Intervention Classrooms

    Science.gov (United States)

    Kodak, Tiffany; Fisher, Wayne W.; Paden, Amber; Dickes, Nitasha

    2013-01-01

    We evaluated a discrete-trial functional analysis implemented by regular classroom staff in a classroom setting. The results suggest that the discrete-trial functional analysis identified a social function for each participant and may require fewer staff than standard functional analysis procedures.

  7. Evaluating post-wildfire hydrologic recovery using ParFlow in southern California

    Science.gov (United States)

    Lopez, S. R.; Kinoshita, A. M.; Atchley, A. L.

    2016-12-01

    Wildfires are naturally occurring hazards that can have catastrophic impacts. They can alter the natural processes within a watershed, such as surface runoff and subsurface water storage. Generally, post-fire hydrologic models are either one-dimensional, empirically-based models, or two-dimensional, conceptually-based models with lumped parameter distributions. These models are useful in providing runoff measurements at the watershed outlet; however, do not provide distributed hydrologic simulation at each point within the watershed. This research demonstrates how ParFlow, a three-dimensional, distributed hydrologic model can simulate post-fire hydrologic processes by representing soil burn severity (via hydrophobicity) and vegetation recovery as they vary both spatially and temporally. Using this approach, we are able to evaluate the change in post-fire water components (surface flow, lateral flow, baseflow, and evapotranspiration). This model is initially developed for a hillslope in Devil Canyon, burned in 2003 by the Old Fire in southern California (USA). The domain uses a 2m-cell size resolution over a 25 m by 25 m lateral extent. The subsurface reaches 2 m and is assigned a variable cell thickness, allowing an explicit consideration of the soil burn severity throughout the stages of recovery and vegetation regrowth. Vegetation regrowth is incorporated represented by satellite-based Enhanced Vegetation Index (EVI) products. The pre- and post-fire surface runoff, subsurface storage, and surface storage interactions are evaluated and will be used as a basis for developing a watershed-scale model. Long-term continuous simulations will advance our understanding of post-fire hydrological partitioning between water balance components and the spatial variability of watershed processes, providing improved guidance for post-fire watershed management.

  8. HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL.

    Science.gov (United States)

    Sudenga, Staci L; Torres, B Nelson; Botha, Matthys H; Zeier, Michele; Abrahamsen, Martha E; Glashoff, Richard H; Engelbrecht, Susan; Schim Van der Loeff, Maarten F; Van der Laan, Louvina E; Kipping, Siegfried; Taylor, Douglas; Giuliano, Anna R

    2017-06-01

    HPV antibodies are a marker of past exposure to the virus. Our objective was to assess HPV serostatus pre- and post-vaccination among HIV-negative women. Women aged 16-24 years old were randomized in a placebo controlled trial utilizing the 4-valent HPV (4vHPV) vaccine (NCT01489527, clinicaltrials.gov). Participants (n=389) received the 4vHPV vaccine or placebo following a three dose schedule. Sera were collected at Day 1 and Month 7 for assessment of HPV 6, 11, 16, and 18 neutralizing antibody levels using a multiplex competitive Luminex immunoassay (Merck) based on detecting the L1 capsid antigen for each HPV type. Seroprevalence was 73% for HPV6, 47% for HPV11, 33% for HPV16, and 44% for HPV18. Seroprevalence for any HPV type did not significantly differ by age or lifetime number of partners. The majority of participants (64%) had two or more 4vHPV antibodies present at enrollment and 12% had antibodies to all four. Among women in the vaccine arm, those that were seropositive for HPV16 at enrollment had higher titers at month 7 compared to women that were seronegative for HPV16 at enrollment; this trend holds for the other HPV types as well. Seroconversion among baseline seronegative participants in the placebo group ranged from 5% for HPV16 to 23% for HPV6. HPV seroprevalence was high in this population, emphasizing the need to vaccinate prior to sexual debut.

  9. Study on post-earthquake plant evaluation and communication (Annual safety research report, JFY 2010)

    International Nuclear Information System (INIS)

    Iijima, Toru; Taoka, Hideto; Yamada, Hiroyuki; Sano, Kyoko

    2011-01-01

    The aims of this study are to establish a post-earthquake plant evaluation method and to develop a communication system for the improving seismic safety regulations as well as encouraging public communication. The Miyagiken-oki earthquake in 2005, Onagawa Nuclear Power Plant shut down automatically. Subsequently, JNES started development of post-earthquake plant evaluation and communication system based on the experience of the cross-check analysis for Onagawa Nuclear Power Plant. The Niigata-ken Chuetsu-oki Earthquake in 2007, the plant situation was not transmitted promptly. The loss of information sharing between local community and related organizations caused the public anxiety. The importance of plant information transmission as well as seismic information gathering were recognized. The proposal for the solution of the information issues were performed by government committee. In this study, the evaluation method for soundness of the main structure and equipment after earthquake event were updated. Moreover, procedure of the post-earthquake plant soundness evaluation and multi-functional seismic information system were developed. In addition, the implementation strategy of the easy-to -understand information dissemination to the public and transparent communication methodology was examined by the Industry-Academia-Government cooperation in the Kashiwazaki-Kariwa region. (author)

  10. Evaluating and Reporting Dysphagia in Trials of Chemoirradiation for Head-and-Neck Cancer

    International Nuclear Information System (INIS)

    Gluck, Iris; Feng, Felix Y.; Lyden, Teresa; Haxer, Marc

    2010-01-01

    Purpose: Reporting long-term toxicities in trials of chemoirradiation (CRT) of head-and-neck cancer (HNC) has mostly been limited to observer-rated maximal Grades ≥3. We evaluated this reporting approach for dysphagia by assessing patient-reported dysphagia (PRD) and objective swallowing dysfunction through videofluoroscopy (VF) in patients with various grades of maximal observer-reported dysphagia (ORD). Methods and Materials: A total of 62 HNC patients completed quality-of-life questionnaires periodically through 12 months post-CRT. Five PRD items were selected: three dysphagia-specific questions, an Eating-Domain, and 'Overall Bother.' They underwent VF at 3 and 12 months, and ORD (Common Terminology Criteria for Adverse Events) scoring every 2 months. We classified patients into four groups (0-3) according to maximal ORD scores documented 3-12 months post-CRT, and assessed PRD and VF summary scores in each group. Results: Differences in ORD scores among the groups were considerable throughout the observation period. In contrast, PRD scores were similar between Groups 2 and 3, and variable in Group 1. VF scores were worse in Group 3 compared with 2 at 3 months but similar at 12 months. In Group 1, PRD and VF scores from 3 through 12 months were close to Groups 2 and 3 if ORD score 1 persisted, but were similar to Group 0 in patients whose ORD scores improved by 12 months. Conclusions: Patients with lower maximal ORD grades, especially if persistent, had similar rates of PRD and objective dysphagia as patients with highest grades. Lower ORD grades should therefore be reported. These findings may have implications for reporting additional toxicities besides dysphagia.

  11. Timely and complete publication of economic evaluations alongside randomized controlled trials.

    Science.gov (United States)

    Thorn, Joanna C; Noble, Sian M; Hollingworth, William

    2013-01-01

    Little is known about the extent and nature of publication bias in economic evaluations. Our objective was to determine whether economic evaluations are subject to publication bias by considering whether economic data are as likely to be reported, and reported as promptly, as effectiveness data. Trials that intended to conduct an economic analysis and ended before 2008 were identified in the International Standard Randomised Controlled Trial Number (ISRCTN) register; a random sample of 100 trials was retrieved. Fifty comparator trials were randomly drawn from those not identified as intending to conduct an economic study. The trial start and end dates, estimated sample size and funder type were extracted. For trials planning economic evaluations, effectiveness and economic publications were sought; publication dates and journal impact factors were extracted. Effectiveness abstracts were assessed for whether they reached a firm conclusion that one intervention was most effective. Primary investigators were contacted about reasons for non-publication of results, or reasons for differential publication strategies for effectiveness and economic results. Trials planning an economic study were more likely to be funded by government (p = 0.01) and larger (p = 0.003) than other trials. The trials planning an economic evaluation had a mean of 6.5 (range 2.7-13.2) years since the trial end in which to publish their results. Effectiveness results were reported by 70 %, while only 43 % published economic evaluations (p economic results included the intervention being ineffective, and staffing issues. Funding source, time since trial end and length of study were not associated with a higher probability of publishing the economic evaluation. However, studies that were small or of unknown size were significantly less likely to publish economic evaluations than large studies (p journal impact factor was 1.6 points higher for effectiveness publications than for the

  12. The application of post yield fracture methodology to the evaluation of large structures

    International Nuclear Information System (INIS)

    Landes, J.D.

    1979-01-01

    The objective of this work is to determine how to use small specimens test results to measure fracture toughness values for application to the evaluation of large structural components. Linear elastic fracture mechanics concepts based on the crack tip stress intensity factor, K, have been extended into the post yield regime by the use of elastic-plastic characterizing parameters such as J integral and COD. One of the primary applications of this technology is the determination of fracture toughness values from small specimens tests taken primarily in the post yield regime which can be used to evaluate structures operating in an essentially linear elastic regime. The fracture toughness values may be either conservative or unconservative depending on the fracture mode; extreme care must be taken in interpretting these results. (orig.)

  13. Evaluation of cluster-randomized trials on maternal and child health research in developing countries

    DEFF Research Database (Denmark)

    Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar

    2009-01-01

    To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...

  14. Nursing home care educational intervention for family caregivers of older adults post stroke (SHARE): study protocol for a randomised trial.

    Science.gov (United States)

    Day, Carolina Baltar; Bierhals, Carla Cristiane Becker Kottwitz; Santos, Naiana Oliveira Dos; Mocellin, Duane; Predebon, Mariane Lurdes; Dal Pizzol, Fernanda Laís Fengler; Paskulin, Lisiane Manganelli Girardi

    2018-02-09

    Family caregivers of aged stroke survivors face challenging difficulties such as the lack of support and the knowledge and skills to practice home care. These aspects negatively influence the caregivers' burden and quality of life, the use of health services, and hospital readmissions of the stroke survivor. The aim of this research is to describe an educational intervention focused on family caregivers of stroke survivors for the development of home care in the south of Brazil. A randomized clinical trial with 48 family caregivers of stroke survivors will be recruited and divided into two groups: 24 in the intervention group and 24 in the control group. The intervention will consist of the systematic follow-up by nurses who will perform three home visits over a period of 1 month. The control group will not receive the visits and will have the usual care guidelines of the health services. Primary outcomes: burden and quality of life of the caregiver. functional capacity and readmissions of the stroke survivors; the use of health services of the stroke survivors and their family caregivers. Outcomes will be measured 2 months after discharge. The project was approved in April 2016. This research offers information for conducting educational intervention with family caregivers of stroke survivors, presenting knowledge so that nurses can structure and plan the actions aimed at the education of the family caregiver. It is expected that the educational intervention will contribute to reducing caregiver burden and improving their quality of life, as well as avoiding readmissions and inadequate use of health services by stroke survivors. ClinicalTrials.gov, ID: NCT02807012 . Registered on 3 June 2016. Name: Nursing Home Care Intervention Post Stroke (SHARE).

  15. A cluster randomised controlled effectiveness trial evaluating perinatal home visiting among South African mothers/infants.

    Directory of Open Access Journals (Sweden)

    Mary Jane Rotheram-Borus

    Full Text Available Interventions are needed to reduce poor perinatal health. We trained community health workers (CHWs as home visitors to address maternal/infant risks.In a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1 the control, healthcare at clinics (n = 12 neighbourhoods; n = 594 women, or 2 a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme, in addition to clinic care (n = 12 neighbourhoods; n = 644 women. Participants were assessed during pregnancy (2% refusal and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received.Benefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p = 0.008; nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR = 1.25; p = 0.014, have infants with healthy weight-for-age measurements (OR = 1.42; p = 0.045, height-for-age measurements (OR = 1.13, p<0.001, breastfeed exclusively for six months (OR = 3.59; p<0.001, and breastfeed longer (OR = 3.08; p<0.001. Number of visits was positively associated with infant birth weight ≥2500 grams (OR = 1.07; p = 0

  16. Outcome when adrenaline (epinephrine) was actually given vs. not given - post hoc analysis of a randomized clinical trial.

    Science.gov (United States)

    Olasveengen, Theresa M; Wik, Lars; Sunde, Kjetil; Steen, Petter A

    2012-03-01

    IV line insertion and drugs did not affect long-term survival in an out-of-hospital cardiac arrest (OHCA) randomized clinical trial (RCT). In a previous large registry study adrenaline was negatively associated with survival from OHCA. The present post hoc analysis on the RCT data compares outcomes for patients actually receiving adrenaline to those not receiving adrenaline. Patients from a RCT performed May 2003 to April 2008 were included. Three patients from the original intention-to-treat analysis were excluded due to insufficient documentation of adrenaline administration. Quality of cardiopulmonary resuscitation (CPR) and clinical outcomes were compared. Clinical characteristics were similar and CPR quality comparable and within guideline recommendations for 367 patients receiving adrenaline and 481 patients not receiving adrenaline. Odds ratio (OR) for being admitted to hospital, being discharged from hospital and surviving with favourable neurological outcome for the adrenaline vs. no-adrenaline group was 2.5 (CI 1.9, 3.4), 0.5 (CI 0.3, 0.8) and 0.4 (CI 0.2, 0.7), respectively. Ventricular fibrillation, response interval, witnessed arrest, gender, age and endotracheal intubation were confounders in multivariate logistic regression analysis. OR for survival for adrenaline vs. no-adrenaline adjusted for confounders was 0.52 (95% CI: 0.29, 0.92). Receiving adrenaline was associated with improved short-term survival, but decreased survival to hospital discharge and survival with favourable neurological outcome after OHCA. This post hoc survival analysis is in contrast to the previous intention-to-treat analysis of the same data, but agrees with previous non-randomized registry data. This shows limitations of non-randomized or non-intention-to-treat analyses. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  17. Using data envelopment analysis to evaluate the performance of post-hurricane electric power restoration activities

    International Nuclear Information System (INIS)

    Reilly, Allison C.; Davidson, Rachel A.; Nozick, Linda K.; Chen, Thomas; Guikema, Seth D.

    2016-01-01

    Post-hurricane restoration of electric power is attracting increasing scrutiny as customers’ tolerance for even short power interruptions decreases. At the peak, 8.5 million customers were without power after Hurricane Sandy and over 1 million customers were without power more than a week after the storm made landfall. Currently, restoration processes are typically evaluated on a case-by-case basis by a regional public service commission or similar body and lack systematic comparisons to other restoration experiences. This paper introduces a framework using data envelopment analysis to help evaluate post-hurricane restorations through comparison with the experiences of other companies in similar storms. The method accounts for the variable severity of the hurricanes themselves, so that companies are not penalized for outages that are long only because the hurricane that caused them was particularly severe. The analysis is illustrated through an application comparing 27 recent post-hurricane restoration experiences across 13 different electric power companies in the United States. The results of the study show some consistency in performance among individual utilities after the hurricanes they experience. The method could be applied to other types of infrastructure systems and other extreme events as well. - Highlights: • A Data Envelopment Analysis (DEA) framework is developed to compare post- hurricane power-outage restoration performance. • Hurricane severity is considered, so that utilities are not penalized for long outages caused by severe storms. • A case study using real data compares 27 recent post-hurricane restoration experiences. • The results of the study show utilities tend to perform consistently after the hurricanes they experience.

  18. Evaluation of ketorolac compared to ketorolac plus dipyrone in post-operative analgesia of videolaparoscopic cholecystectomy

    Directory of Open Access Journals (Sweden)

    Silvia Katlauskas Muraro

    2009-03-01

    Full Text Available Objectives: To compare the analgesic effect of ketorolac with the association of ketorolac plus dipyrone after videolaparoscpic cholecystectomy and with a placebo group. Methods: After approval by the Research Ethics Committee and after having the informed consent signed, 60 patients aged between 18 and 60 years who underwent videolaparoscopic cholecystectomy were evaluated for the post-operative analgesia provided by ketorolac compared to ketorolac plus dipyrone. The patients underwent general anesthesia (with propofol, alfentanil, rocuronium and maintenance with isoflurane. Twenty patients received 20 ml water, 20 patients received ketorolac 30 mg in 20 ml water and 20 received ketorolac 30 mg plus dipyrone 2 g in 20 ml water, during anesthetic induction. In the post-operative recovery room, the patients were evaluated to the moment of their first pain complaint with the use of a visual analogue scale and a verbal pain scale every hour in the first six hours. When necessary, morphine was administered as a rescue medication for pain relief and a PCA pump with morphine solution was turned on. Rresults: Total morphine use was lower in the ketorolac plus dipyrone Group (2 mg and in the ketorolac (2 mg Group, compared to the placebo Group (10.5 mg. Of 20 cases of ketorolac plus dipyrone, eight patients did not complain of pain in the post-operative period, while only three patients did not complain in the ketorolac Group and in the placebo Group (p = 0,05. Cconclusion: Ketorolac is a potent analgesic agent widely used for acute pain treatment, especially after surgeries, with an analgesic potency comparable to that of opiates, the most commonly drugs used during the post-operative of medium to major surgeries. In this study, the results analyzed at this moment show that the association of ketorolac plus dipyrone seemed to be superior to post-operative analgesia compared to the use of ketorolac.

  19. Defining, evaluating, and removing bias induced by linear imputation in longitudinal clinical trials with MNAR missing data.

    Science.gov (United States)

    Helms, Ronald W; Reece, Laura Helms; Helms, Russell W; Helms, Mary W

    2011-03-01

    Missing not at random (MNAR) post-dropout missing data from a longitudinal clinical trial result in the collection of "biased data," which leads to biased estimators and tests of corrupted hypotheses. In a full rank linear model analysis the model equation, E[Y] = Xβ, leads to the definition of the primary parameter β = (X'X)(-1)X'E[Y], and the definition of linear secondary parameters of the form θ = Lβ = L(X'X)(-1)X'E[Y], including, for example, a parameter representing a "treatment effect." These parameters depend explicitly on E[Y], which raises the questions: What is E[Y] when some elements of the incomplete random vector Y are not observed and MNAR, or when such a Y is "completed" via imputation? We develop a rigorous, readily interpretable definition of E[Y] in this context that leads directly to definitions of β, Bias(β) = E[β] - β, Bias(θ) = E[θ] - Lβ, and the extent of hypothesis corruption. These definitions provide a basis for evaluating, comparing, and removing biases induced by various linear imputation methods for MNAR incomplete data from longitudinal clinical trials. Linear imputation methods use earlier data from a subject to impute values for post-dropout missing values and include "Last Observation Carried Forward" (LOCF) and "Baseline Observation Carried Forward" (BOCF), among others. We illustrate the methods of evaluating, comparing, and removing biases and the effects of testing corresponding corrupted hypotheses via a hypothetical but very realistic longitudinal analgesic clinical trial.

  20. Evaluating FDG uptake changes between pre and post therapy respiratory gated PET scans

    International Nuclear Information System (INIS)

    Aristophanous, Michalis; Yong, Yue; Yap, Jeffrey T.; Killoran, Joseph H.; Allen, Aaron M.; Berbeco, Ross I.; Chen, Aileen B.

    2012-01-01

    Purpose: Whole body (3D) and respiratory gated (4D) FDG-PET/CT scans performed pre-radiotherapy (pre-RT) and post-radiotherapy (post-RT) were analyzed to investigate the impact of 4D PET in evaluating 18F-fluorodeoxyglucose (FDG) uptake changes due to therapy, relative to traditional 3D PET. Methods and materials: 3D and 4D sequential FDG-PET/CT scans were acquired pre-RT and approximately one month post-RT for patients with non-small cell lung cancer (NSCLC). The lesions of high uptake targeted with radiotherapy were identified on the pre-RT scan of each patient. Each lesion on the 3D and each of the five phases of the 4D scan were analyzed using a region of interest (ROI). For each patient the ROIs of the pre-RT scans were used to locate the areas of initial FDG uptake on the post-RT scans following rigid registration. Post-RT ROIs were drawn and the FDG uptake was compared with that of the pre-RT scans. Results: Sixteen distinct lesions from 12 patients were identified and analyzed. Standardized uptake value (SUV) maxima were significantly higher (p-value <0.005) for the lesions as measured on the 4D compared to 3D PET. Comparison of serial pre and post-RT scans showed a mean 62% decrease in SUV with the 3D PET scan (range 36–89%), and a 67% decrease with the 4D PET scan (range 30–89%). The mean absolute difference in SUV change on 3D versus 4D scans was 4.9%, with a range 0–15% (p-value = 0.07). Conclusions: Signal recovery with 4D PET results in higher SUVs when compared to standard 3D PET. Consequently, differences in the evaluation of SUV changes between pre and post-RT plans were observed. Such difference can have a significant impact in PET-based response assessment.

  1. Evaluation of post-operative prophylactic irradiation for carcinoma of the esophagus

    International Nuclear Information System (INIS)

    Mafune, Ken-ichi; Tanaka, Yoichi; Fujita, Kichishiro; Sakura, Mizuyoshi

    1987-01-01

    Of 147 patients with carcinoma of the esophagus resected at Saitama Cancer Center Hospital for 10 years, 98 cases were studied to evaluate post-operative prophylactic irradiation. The total dose of irradiation was up to 4,000 ∼ 5,000 rads of Linac X-ray and the irradiated field was T-shaped covering the upper mediastinal and bilateral cervical regions. The prognosis of the post-operative irradiated group (56 cases) was significantly better than that of the control group (42 cases) (p < 0.01). This study resulted in a five-year survival rate of 34.2 percent for patients in the post-operative irradiated group, compared to 16.7 percent for those in the control group. Further detailed comparative studies revealed similar results. Cancer recurrence occurred at the irradiated fields in 8 cases (14.3 %), though in 15 cases (35.7 %) of the control group. This suggested the local suppressive effect of the post-operative irradiation to the cancer recurrence. (author)

  2. Pediatric dentistry clinical education venues evaluation by pre and post-doctoral students.

    Science.gov (United States)

    Bimstein, E; Mayes, A; Mittal, Hc

    2014-01-01

    To evaluate dental students' perspectives about pre- and post-doctoral pediatric dentistry education venues. Surveys with visual analog scales (from 0 to 100) measuring the educational contribution of pediatric dentistry venues were conducted. The pre-doctoral venues included a 3rd year university twilight clinic (UTC), a 3rd year urban community based clinic (CBC) and 4th year mobile clinics (MCs). The post-doctoral venues included treatment of children under general anesthesia, oral sedations, a regular clinic (no sedations), seminars, journal club, case conferences and studding for the American Board of Pediatric Dentistry. Analyses of variance between the scores indicated that the 3rd year CBC score (68.2 ± 4.5) was statistically significant higher (p= .007) than the one for the 3rd year UTC score (44.9 ± 6.1). The 4th year students' MCs score (61.4 ± 4.0) was statistically significant higher than their retrospective scores for the 3rd year CBC (56.4 ± 4.4) or UTC (42.2 ± 4.9) scores (p= .03 and .004 respectively). Among the didactic or clinical post-doctoral venues, the regular clinic and the seminars received the highest scores (84.3 ± 1.7 and 71.6 ± 2.8 respectively). pre-doctoral community-based clinical education and post-doctoral regular university based clinic are considered by students to provide the main contribution to pediatric dental education.

  3. The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients.

    Science.gov (United States)

    Kim, Choung-Soo; Theeuwes, Ad; Kwon, Dong Deuk; Choi, Young Deuk; Chung, Byung Ha; Lee, Hyun Moo; Lee, Kang Hyun; Lee, Sang Eun

    2016-05-01

    This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. Asymptomatic or mildly symptomatic chemotherapy-naive men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50% decline), and time to skeletal-related event. Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95% confidence interval) for enzalutamide versus placebo were 0.23 (0.02-2.24) for centrally assessed rPFS, 0.77 (0.28-2.15) for OS, 0.21 (0.08-0.51) for time to chemotherapy, and 0.31 (0.17-0.56) for time to PSA progression. A PSA response was observed in 70.0% of enzalutamide-treated and 10.5% of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33% of enzalutamide-treated and 11% of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97-1.10). In Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population (ClinicalTrials.gov Identifier: NCT01212991).

  4. Likelihood of myocardial infarction during stroke rehabilitation preceded by cardiovascular screening and an exercise tolerance test: the Locomotor Experience Applied Post-Stroke (LEAPS) trial.

    Science.gov (United States)

    Nadeau, Stephen E; Rose, Dorian Kay; Dobkin, Bruce; Wu, Samuel S; Dai, Yufeng E; Schofield, Richard; Duncan, Pamela W

    2014-12-01

    Coronary artery disease is highly prevalent in patients with stroke, but because revascularization does not improve major clinical outcomes in patients with stable coronary artery disease relative to intensive medical therapy, routine evaluation for this disease is not warranted in stroke patients. However, it might be warranted in patients destined to undergo vigorous physical therapy. The Locomotor Experience Applied Post-Stroke study, a randomized controlled trial of 408 participants that tested the relative efficacy of two rehabilitation techniques on functional walking level, provided the opportunity to address this question. The study aims to test the efficacy of screening for cardiovascular disease and an exercise tolerance test in assuring safety among patients undergoing vigorous rehabilitation for gait impairment. All participants were screened for serious cardiovascular and pulmonary conditions. At six-weeks poststroke, they also completed a cardiovascular screening inventory and underwent an exercise tolerance test involving bicycle ergometry. Participants received 36, 90-min sessions of a prescribed physical therapy (three per week), initiated at either two-months or six-months poststroke. Twenty-nine participants were excluded on the basis of the cardiac screening questionnaire, and 15 failed the exercise tolerance test for cardiovascular reasons. No participant experienced a cardiac event during a treatment session. Two participants experienced myocardial infarctions, but continued in the trial. In three additional participants, myocardial infarctions caused or contributed to death. The combination of a negative cardiac screen and the absence of exercise tolerance test failure appeared to have a high negative predictive value for cardiac events during treatment, despite the likelihood of a high prevalence of coronary artery disease in our population. © 2014 World Stroke Organization.

  5. Combination of intracostal sutures with muscle flap to decrease post thoracotomy pain: A single blinded randomized clinical trial.

    Science.gov (United States)

    Montazer, Majid; Hashemzade, Shahryar; Gargari, Reza Movassaghi; Ramouz, Ali; Sanaie, Sarvin; Rasihashemi, Seyed Ziaeddin

    2017-01-01

    To assess the efficacy of intercostal nerve protection by intercostal muscle (ICM) flap in post-thoracotomy pain improvement compared to intracostal suturing. In a randomized controlled trial, ninety-four patients undergoing posterolateral thoracotomy surgery were divided into two subgroups. Intracostal sutures in isolation and in combination with ICM flap techniques were used for thoracotomy closure in both groups. Numeric Pain Scale and Visual Pain Scale as pain scores were assessed on the first, second, third, fourth, fifth, sixth and seventh postoperative days and follow-up visits during the 2 nd week, 1 st , 2 nd , 4 th and 6 th months after thoracotomy. Out of 94 patients, 58 were male and 36 were females. While the mean age of patients in intracostal group was 45.3 ± 17.6 years, it was 47.4 ± 16.1 years in intracostal plus ICM flap group. The mean operation time for the first group was 191.0 ± 74.7 minutes, while it was 219.3 ± 68.8 minutes in the second (p>0.05). Numeric rating score and visual pain scale did not demonstrate any significant difference in pain severity on postoperative days and follow-up visits between both groups (p>0.05). Although the trend of pain reduction was significant in each group (p0.001). Intracostal sutures in combination with muscle flap did not reduce postoperative pain in thoracotomy compared with intracostal sutures alone in thoracotomy closure.

  6. Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT.

    Science.gov (United States)

    Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie

    2016-05-10

    The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT). A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to 'get staff on board', and developing different ways of working. The AVERT stroke rehabilitation trial required commitment to deliver an intervention that needed strong collaboration between nurses and

  7. The Psychosocial and Independent Living Donor Advocate Evaluation and Post-surgery Care of Living Donors.

    Science.gov (United States)

    Rudow, Dianne LaPointe; Swartz, Kathleen; Phillips, Chelsea; Hollenberger, Jennifer; Smith, Taylor; Steel, Jennifer L

    2015-09-01

    Solid organ transplantation as a treatment for end stage organ failure has been an accepted treatment option for decades. Despite advances in medicine and technology, and increased awareness of organ donation and transplantation, the gap between supply and demand continues to widen. Living donation has been an option that has increased the number of transplants despite the continued shortage of deceased organs. In the early 2000s live donor transplantation reached an all-time high in the United States. As a result, a consensus meeting was convened in 2000 to increase the oversight of living donor transplantation. Both the Centers for Medicare and Medicaid Services and the United Network for Organ Sharing developed regulations that transplant programs performing live donor transplantation. These regulations and guidelines involve the education, evaluation, informed consent process and living donor follow-up care. Two areas in which had significant changes included the psychosocial and the independent living donor advocate (ILDA) evaluation. The purpose of this paper was to outline the current regulations and guidelines associated with the psychosocial and ILDA evaluation as well as provide further recommendations for the administration of a high quality evaluation of living donors. The goals and timing of the evaluation and education of donors; qualifications of the health care providers performing the evaluation; components of the evaluation; education provided to donors; documentation of the evaluation; participation in the selection committee meeting; post-decline and post-donation care of donors is described. Caveats including the paired donor exchange programs and non-directed and directed donation are also considered.

  8. Evaluation of an interprofessional educational curriculum pilot course for practitioners working with post-stroke patients.

    Science.gov (United States)

    Olaisen, Rho Henry; Mariscal-Hergert, Cheryl; Shaw, Alissa; Macchiavelli, Cecilia; Marsheck, Joanna

    2014-03-01

    This report describes the design and evaluation of an interprofessional pilot training course aimed at pre-licensure practitioners working with post-stroke patients in community-based settings. The course was developed by community-based practitioners from nine health professions. Course learning activities included traditional methods (lectures) and interactive modules (problem-based learning and exchange-based learning). The study's aim was to assess the program's effectiveness in adapting and incorporating knowledge, skills and self-confidence when delivering tertiary care in therapeutic pool environments; gauge adoption of course principles into practice, and assess overall course satisfaction. Methods of evaluation included conceptual mapping of course format, pre- and post-questionnaires, daily reflection questionnaires, course satisfaction survey and adoption survey, 10 weeks follow-up. Overall, the findings indicate students' knowledge, skills and self-confidence in delivering effective post-stroke care increased following the training. Students reported adopting clinical practices in 10 weeks follow-up. Implications for designing interprofessional curricula are discussed.

  9. Determinants of continuance intention in a post-adoption satisfaction evaluation of a clinical information system.

    Science.gov (United States)

    Hadji, Brahim; Dupuis, Isabelle; Leneveut, Laurence; Heudes, Didier; Wagner, Jean-François; Degoulet, Patrice

    2014-01-01

    The evaluation of end-user satisfaction is an essential part of any clinical information system (CIS) project. The purpose of this study is to evaluate the determinants of CIS continuance intention in a late post-adoption phase at the Georges Pompidou University Hospital (HEGP) in Paris. We designed an electronic survey instrument based on an IT post-adoption model (ITPAM) developed from three previous models, i.e., the Delone and McLean Information Success Model, the Davis TAM model and the Bhattacherjee information system continuance intention model. 419 questionnaires were collected from CIS users directly involved in patient care. The perceived CIS quality, usefulness and user satisfaction are significantly lower for medical professions than other professional groups. Continuance intention is very high within all professional subgroups. In a multiple regression analysis, the global satisfaction (R(2) = .780) was positively and significantly correlated with CIS quality, confirmation of expectations and perceived CIS usefulness. The continuance intention (R(2) = .392) was positively and significantly correlated with perceived CIS usefulness, confirmation of expectations and global satisfaction. In a late post-adoption CIS deployment phase, continuance intention does not significantly depend on individual end user characteristics but is significantly associated with the perceived CIS usefulness, confirmation of expectations and global satisfaction.

  10. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    Science.gov (United States)

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  11. Post-prandial effects of hazelnut-enriched high fat meal on LDL oxidative status, oxidative and inflammatory gene expression of healthy subjects: a randomized trial.

    Science.gov (United States)

    Di Renzo, L; Merra, G; Botta, R; Gualtieri, P; Manzo, A; Perrone, M A; Mazza, M; Cascapera, S; De Lorenzo, A

    2017-04-01

    Postprandial oxidative stress is characterized by an increased susceptibility of the organism towards oxidative damage after consumption of a meal rich in lipids and/or carbohydrates. Micronutrients modulate the immune system and exert a protective action by reducing low-density lipoproteins oxidation (ox-LDL) via induction of antioxidant enzymes. The clinical study was a randomized and cross-over trial, conducted through the CONSORT flowchart. We evaluated the gene expression of 103 genes related to oxidative stress (HOSp) and human inflammasome pathways (HIp), and ox-LDL level at fasting and after 40 g raw "Tonda Gentile delle Langhe" hazelnut consumption, in association with a McDonald's® Meal (McDM) in 22 healthy human volunteers. Ox-LDL levels significantly increased comparing no dietary treatment (NDT) vs. McDM, and decreased comparing McDM vs. McDM + H (p<0.05). Percentage of significant genes expressed after each dietary treatment were the follows: (A) NDT vs. McDM: 3.88% HIp and 17.48% HOSp; (B) NDT vs. McDM + H: 17.48% HIp and 23.30% HOSp; (C) McDM vs. McDM + H: 17.48% HIp and 33.98% HOSp. Hazelnut consumption reduced post prandial risk factors of atherosclerosis, such as ox-LDL, and the expression of inflammation and oxidative stress related genes. Chronic studies on larger population are necessary before definitive conclusions.

  12. A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design

    Directory of Open Access Journals (Sweden)

    Alla Guekht

    2013-12-01

    Full Text Available Background: No drug treatment to date has shown convincing clinical evidence of restoring cognitive function or preventing further decline after stroke. The ongoing ARTEMIDA study will evaluate the efficacy and safety of Actovegin for the symptomatic treatment of post-stroke cognitive impairment (PSCI and will explore whether Actovegin has any disease-modifying effect by assessing whether any changes are sustained after treatment. Design: ARTEMIDA is a 12-month, multicentre trial in patients (planned a total of 500, now recruited with cognitive impairment following ischaemic stroke. The study consists of a baseline screening (≤7 days after stroke, after which eligible patients are randomised to Actovegin (2,000 mg/day for up to 20 intravenous infusions followed by 1,200 mg/day orally or placebo for a 6-month double-blind treatment period. Patients will be followed up for a further 6 months, during which time they will be treated in accordance with standard clinical practice. The primary study endpoint is change from baseline in the Alzheimer's Disease Assessment Scale, cognitive subscale, extended version. Secondary outcomes include: Montreal Cognitive Assessment; dementia diagnosis (ICD-10; National Institutes of Health Stroke Scale; Barthel Index; EQ-5D; Beck Depression Inventory, version II, and safety. Conclusion: There is a clear need for effective treatments for PSCI. ARTEMIDA should provide important insights into the use of a novel drug therapy for PSCI.

  13. Evaluation of field trials of innovative practices in science education

    OpenAIRE

    Gerloff-Gasser, C; Büchel, K

    2012-01-01

    Science and technology (S&T) education is vital to increase the science literacy in modern societies and to stimulate more young people to opt for careers in S&T. Because there are considerable differences in S&T education among and sometimes within countries, it is promising to adopt an adaptive strategy to its innovation that allows a fit to the specific conditions of each of the countries. In this report, we present first results of field trials with innovative practices in S&T educatio...

  14. Post annealing performance evaluation of printable interdigital capacitive sensors by principal component analysis

    KAUST Repository

    Zia, Asif Iqbal

    2015-06-01

    The surface roughness of thin-film gold electrodes induces instability in impedance spectroscopy measurements of capacitive interdigital printable sensors. Post-fabrication thermodynamic annealing was carried out at temperatures ranging from 30 °C to 210 °C in a vacuum oven and the variation in surface morphology of thin-film gold electrodes was observed by scanning electron microscopy. Impedance spectra obtained at different temperatures were translated into equivalent circuit models by applying complex nonlinear least square curve-fitting algorithm. Principal component analysis was applied to deduce the classification of the parameters affected due to the annealing process and to evaluate the performance stability using mathematical model. Physics of the thermodynamic annealing was discussed based on the surface activation energies. The post anneal testing of the sensors validated the achieved stability in impedance measurement. © 2001-2012 IEEE.

  15. Post annealing performance evaluation of printable interdigital capacitive sensors by principal component analysis

    KAUST Repository

    Zia, Asif Iqbal; Mukhopadhyay, Subhas Chandra; Yu, Paklam; Al-Bahadly, Ibrahim H.; Gooneratne, Chinthaka Pasan; Kosel, Jü rgen

    2015-01-01

    The surface roughness of thin-film gold electrodes induces instability in impedance spectroscopy measurements of capacitive interdigital printable sensors. Post-fabrication thermodynamic annealing was carried out at temperatures ranging from 30 °C to 210 °C in a vacuum oven and the variation in surface morphology of thin-film gold electrodes was observed by scanning electron microscopy. Impedance spectra obtained at different temperatures were translated into equivalent circuit models by applying complex nonlinear least square curve-fitting algorithm. Principal component analysis was applied to deduce the classification of the parameters affected due to the annealing process and to evaluate the performance stability using mathematical model. Physics of the thermodynamic annealing was discussed based on the surface activation energies. The post anneal testing of the sensors validated the achieved stability in impedance measurement. © 2001-2012 IEEE.

  16. [Rehabilitation evaluation on post-stroke abnormal movement pattern prevented and treated with acupuncture and rehabilitation].

    Science.gov (United States)

    Zhang, Hui-min; Tang, Qiang

    2011-06-01

    To explore the impacts of acupuncture and rehabilitation on post-stroke abnormal patterns of limb movement and evaluate them via rehabilitation method. Ninety cases of post-stroke movement disorder were randomly divided into an acupuncture-rehabilitation group, a body acupuncture group and a medication group, 30 cases in each group. In medication group, the conventional medication in neurological department was administered. In acupuncture-rehabilitation group and body acupuncture group, on the basis of the therapy as medication group, scalp acupuncture (such as parietal area and anterior parietal area, etc.), rehabilitation training and traditional body acupuncture [such as Jianyu (LI 15) and Fengshi (GB 31),etc.] were supplemented. The continuous electric stimulation was applied in body acupuncture group. The treatment lasted for 8 weeks. The assessment of clinical efficacy, Fugl-Meyer score, Modified Ashworth scale (MAS), range of motion (ROM) and shoulder pain score were taken as observation indices for rehabilitation evaluation before and after treatment in each group. The effective rate was 93.1% (27/29) in acupuncture-rehabilitation group, which was superior to 66.7% (20/30) in body acupuncture group and 57.1% (16/28) in control group (both Prehabilitation group were significantly superior to those in body acupuncture group and medication group (Prehabilitation therapy and traditional body acupuncture remarkably improve in post-stroke movement disorder. But acupuncture and rehabilitation therapy is apparently superior to traditional body acupuncture. This therapy can effectively prevent and treat post-stroke abnormal patterns and it is greatly significant in the improvement of survival quality for the patients.

  17. Ex post and ex ante evaluation of the long term management plan for sole and plaice in the North Sea (part 1): ex post

    NARCIS (Netherlands)

    Miller, D.C.M.; Poos, J.J.

    2009-01-01

    This report describes the first part of an ex post and ex ante evaluation of the long term management plan for sole and plaice in the North Sea as laid out in Council Regulation (EC) No 676/2007. This plan has been in place since 2007. The plan aims to ensure, in its first stage, that the stocks of

  18. Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Johannsen, Maja; O Connor, Maja; OToole, Mia Skytte

    2016-01-01

    PURPOSE: To assess the efficacy of mindfulness-based cognitive therapy (MBCT) for late post-treatment pain in women treated for primary breast cancer. METHODS: A randomized wait list-controlled trial was conducted with 129 women treated for breast cancer reporting post-treatment pain (score ≥ 3...... pain rehabilitation strategy for women treated for breast cancer. In addition, the effect on neuropathic pain, a pain type reported by women treated for breast cancer, further suggests the potential of MBCT but should be considered preliminary....

  19. Evaluation of post-surgical relapse after mandibular setback surgery with minimal orthodontic preparation.

    Science.gov (United States)

    Lee, Nam-Ki; Kim, Young-Kyun; Yun, Pil-Young; Kim, Jong-Wan

    2013-01-01

    The aim of this study was to evaluate of the patterns of post-surgical relapse after mandibular setback surgery with minimal orthodontic preparation (MS-MO). The subjects consisted of 15 patients with minimal pre-surgical orthodontic preparation (1.37 ± 1.69 months). Lateral cephalograms were taken in pre-surgical (T0), post-surgical 1 month (T1) and immediately after debonding (T2) stages. To evaluate the surgical changes (T1-T0) and the relapse (T2-T1), the linear and angular measurements were analyzed using paired t-test. Pearson's correlation coefficients of the horizontal and vertical relapses of Pog and Me to other measurements were calculated. Pog or Me in T1 were displaced rotationally on Ar-Pog or Ar-Me lines in T2 to evaluate the remaining surgical relapse except the rotational relapse from total relapse. The mandible relapsed anteriorly 3.53 mm (Pog) and 4.00 mm (Me) and superiorly 2.72 mm (Pog) and 2.44 mm (Me). FH to Ar-Pog and FH to Ar-Me decreased by about 2°. Pure surgical relapses at Pog and Me, except rotational relapses, were about 0.5 mm anteriorly and inferiorly 0.8 mm. The vertical relapse might induce mandibular rotation with the horizontal relapse. For an accurate prediction after MS-MO, the rotational relapse might be considered. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

  20. Study on post-earthquake plant evaluation and communication (Annual safety research report, JFY 2011)

    International Nuclear Information System (INIS)

    2012-01-01

    The aims of this study are to establish a post-earthquake plant evaluation method and to develop a communication system for the improving seismic safety regulations as well as encouraging public communication. The Miyagiken-oki earthquake in 2005, Onagawa Nuclear Power Plant shut down automatically. Subsequently, JNES started development of post-earthquake plant evaluation and communication system based on the experience of the cross-check analysis for Onagawa Nuclear Power Plant. The Niigata-ken Chuetsu-oki Earthquake in 2007, the plant situation was not transmitted promptly. The loss of information sharing between local community and related organizations caused the public anxiety. The importance of plant information transmission as well as seismic information gathering were recognized. The proposal for the solution of the information issues were performed by government committee, In this study the evaluation method for soundness of the main structure and equipment after earthquake event were updated. Moreover, information dissemination to the public and transparent communication methodology was examined by the Industry-Academia-Government cooperation in the Kashiwazaki-Kariwa region. (author)

  1. Clinical uses of melatonin: evaluation of human trials.

    Science.gov (United States)

    Sánchez-Barceló, E J; Mediavilla, M D; Tan, D X; Reiter, R J

    2010-01-01

    During the last 20 years, numerous clinical trials have examined the therapeutic usefulness of melatonin in different fields of medicine. The objective of this article is to review, in depth, the science regarding clinical trials performed to date. The efficacy of melatonin has been assessed as a treatment of ocular diseases, blood diseases, gastrointestinal tract diseases, cardiovascular diseases, diabetes, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, infectious diseases, neurological diseases, sleep disturbances, aging and depression. Melatonin has been also used as a complementary treatment in anaesthesia, hemodialysis, in vitro fertilization and neonatal care. The conclusion of the current review is that the use of melatonin as an adjuvant therapy seems to be well funded for macular degeneration, glaucoma, protection of the gastric mucosa, irritable bowel syndrome, arterial hypertension, diabetes, side effects of chemotherapy and radiation in cancer patients or hemodialysis in patients with renal insufficiency and, especially, for sleep disorders of circadian etiology (jet lag, delayed sleep phase syndrome, sleep deterioration associated with aging, etc.) as well as in those related with neurological degenerative diseases (Alzheimer, etc.,) or Smith-Magenis syndrome. The utility of melatonin in anesthetic procedures has been also confirmed. More clinical studies are required to clarify whether, as the preliminary data suggest, melatonin is useful for treatment of fibromyalgia, chronic fatigue syndrome, infectious diseases, neoplasias or neonatal care. Preliminary data regarding the utility of melatonin in the treatment of ulcerative colitis, Crohn's disease, rheumatoid arthritis are either ambiguous or negative. Although in a few cases melatonin seems to aggravate some conditions, the vast majority of studies document the very low toxicity of melatonin over a wide range of doses.

  2. A further evaluation of herbicides for post-emergence use in short rotation coppice

    Energy Technology Data Exchange (ETDEWEB)

    Turnbull, D.J.

    2002-07-01

    This report summarises the findings of a project evaluating the safety and efficiency of eleven herbicides for controlling weeds in newly plated willow short rotation coppices, and provides growers with information on post-emergence herbicide options, control of problem weeds, and emergency treatments. Weed germination, crop safety, and the encouraging results obtained using Reflex T and Impuls are discussed. It is suggested that a Technical Register of herbicide applications with contributions by growers and advisers should be considered by the British Biogen trade industry body.

  3. An evaluation of herbicides for post-emergence use in short rotation coppice

    Energy Technology Data Exchange (ETDEWEB)

    Turnbull, D.J.

    2000-07-01

    The objective of the project was to evaluate the safety and efficacy of a range of herbicides and mixtures of herbicides, with both contact and residual activity, for the post-emergence control of weeds in newly planted willow short rotation coppice (SRC). This report provides growers and advisers of short rotation coppice with important (but still limited) information on how to achieve improved weed control of problem weeds increasingly prevalent in SRC fields. This may provide guidance towards often-essential emergency treatments when the crop establishment is under considerable pressure and the potential safety, or otherwise, of certain weed-specific herbicides. (author)

  4. A CLINICAL EVALUATION OF POST-PARTUM DEPRESSION IN COASTAL KARNATAKA

    Directory of Open Access Journals (Sweden)

    Annappa Shetty

    2016-09-01

    Full Text Available BACKGROUND Psychological mood changes, depression is very common in Post-partum period ranging from mild and transient “baby blues” experienced by 50-80% of women to postpartum Psychosis which affects 1% of women. AIMS AND OBJECTIVE To evaluate the association of different factors with Post-Partum depression in coastal Karnataka region, (Karwar. MATERIAL & METHODS  A Prospective study was conducted in the department of Obstetrics and Gynaecology, KAIMS, Karwar, Karnataka.  A total one thousand patients 4-7 Post-partum days were selected and interrogated using Edinburgh Postnatal depression scale (EPDS. Socio-demographic factors (age, Parity, literacy, socio-economic status, marital status and family structure, history of psychiatric disorders and abuse, mode of delivery and the obstetric outcome were recorded. The results were analysed statistically using Chi-square chart. STATISTICAL ANALYSIS AND RESULTS: The incidence of PPD was 22%. Significant association of PPD was seen with low socio-economic status group (P<005, poor literacy (P<0.001, nuclear family structure (P<0.05, single mother (P<0.001, past history of abuse (P<0.05 and poor obstetric outcome (P<0.001. CONCLUSION This study provides useful information about the prevalence of PPD and the association of socio economic, cultural practices prevalent in coastal Karnataka with PPD.

  5. Randomized controlled evaluation of an early intervention to prevent post-rape psychopathology.

    Science.gov (United States)

    Resnick, Heidi; Acierno, Ron; Waldrop, Angela E; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J; Kilpatrick, Dean

    2007-10-01

    A randomized between-group design was used to evaluate the efficacy of a video intervention to reduce post-traumatic stress disorder (PTSD) and other mental health problems, implemented prior to the forensic medical examination conducted within 72 h post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) aged 15 years or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with a prior rape history relative to scores among women with a prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior rape history who were in the video relative to the standard care condition. Small effects indicating higher PTSD and Beck Anxiety Inventory (BAI) scores among women without a prior rape history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a videoxprior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms.

  6. Evaluating remedial alternatives for an acid mine drainage stream: A model post audit

    Science.gov (United States)

    Runkel, Robert L.; Kimball, Briant A.; Walton-Day, Katherine; Verplanck, Philip L.; Broshears, Robert E.

    2012-01-01

    A post audit for a reactive transport model used to evaluate acid mine drainage treatment systems is presented herein. The post audit is based on a paired synoptic approach in which hydrogeochemical data are collected at low (existing conditions) and elevated (following treatment) pH. Data obtained under existing, low-pH conditions are used for calibration, and the resultant model is used to predict metal concentrations observed following treatment. Predictions for Al, As, Fe, H+, and Pb accurately reproduce the observed reduction in dissolved concentrations afforded by the treatment system, and the information provided in regard to standard attainment is also accurate (predictions correctly indicate attainment or nonattainment of water quality standards for 19 of 25 cases). Errors associated with Cd, Cu, and Zn are attributed to misspecification of sorbent mass (precipitated Fe). In addition to these specific results, the post audit provides insight in regard to calibration and sensitivity analysis that is contrary to conventional wisdom. Steps taken during the calibration process to improve simulations of As sorption were ultimately detrimental to the predictive results, for example, and the sensitivity analysis failed to bracket observed metal concentrations.

  7. Evaluation of hepatitis A vaccine in post-exposure prophylaxis, The Netherlands, 2004-2012.

    Directory of Open Access Journals (Sweden)

    Jane Whelan

    Full Text Available The secondary attack rate of hepatitis A virus (HAV among contacts of cases is up to 50%. Historically, contacts were offered immunoglobulin (IG, a human derived blood product as post-exposure prophylaxis (PEP. Amid safety concerns about IG, HAV vaccine is increasingly recommended instead. Public health authorities' recommendations differ, particularly for healthy contacts ≥40 years old, where vaccine efficacy data is limited. We evaluated routine use of HAV vaccine as an alternative to immunoglobulin in PEP, in those considered at low risk of severe infection in the Netherlands.Household contacts of acute HAV cases notified in Amsterdam (2004-2012 were invited ≤14 days post-exposure, for baseline anti-HAV testing and PEP according to national guidelines: immunoglobulin if at risk of severe infection, or hepatitis A vaccine if healthy and at low risk (aged 40 years of age. In healthy contacts vaccinated per-protocol ≤8 days post-exposure, RR(ref. ≤15 years of secondary infection in those >40 years was 12.0 (95%CI:1.3-106.7.Timely administration of HAV vaccine in PEP was feasible and the secondary attack rate was low in those 40 years of age and those vulnerable to severe disease.

  8. Evaluation of role of brain SPECT in diagnosis of post stroke dementia

    International Nuclear Information System (INIS)

    Yousepour, G.; Alavi, M.

    2003-01-01

    Post stroke dementia is one of the most common complications of stroke that is preventable and relatively treatable too. The purpose of the study is comparison between the positive findings in the brain CT scan and brain perfusion SPECT. 15 patients who were complicated by dementia after cerebrovascular accident and also 5 patients as a control group enrolled in this study. Brain CT scan and brain SPECT were performed during at most one week after stroke. Abnormal findings in both brain CT scan and SPECT were seen in 46% of patients. Brain CT scan disclosed more abnormal findings compared to brain SPECT (33.3%). While brain SPECT findings were more information than brain CT scan (20%) this study is indicating that brain CT scan and the brain SPECT concomitantly for each other in better diagnosis of post stroke dementia. We did not find any specific diagnostic pattern in brain SPECT of patients suffering from post stroke dementia. The low quality of brain SPECT in spite of uniformity of gamma camera may be suggestive of low quality of Iran produced ECD kit that needs further evaluation

  9. Evaluating remedial alternatives for an acid mine drainage stream: a model post audit.

    Science.gov (United States)

    Runkel, Robert L; Kimball, Briant A; Walton-Day, Katherine; Verplanck, Philip L; Broshears, Robert E

    2012-01-03

    A post audit for a reactive transport model used to evaluate acid mine drainage treatment systems is presented herein. The post audit is based on a paired synoptic approach in which hydrogeochemical data are collected at low (existing conditions) and elevated (following treatment) pH. Data obtained under existing, low-pH conditions are used for calibration, and the resultant model is used to predict metal concentrations observed following treatment. Predictions for Al, As, Fe, H(+), and Pb accurately reproduce the observed reduction in dissolved concentrations afforded by the treatment system, and the information provided in regard to standard attainment is also accurate (predictions correctly indicate attainment or nonattainment of water quality standards for 19 of 25 cases). Errors associated with Cd, Cu, and Zn are attributed to misspecification of sorbent mass (precipitated Fe). In addition to these specific results, the post audit provides insight in regard to calibration and sensitivity analysis that is contrary to conventional wisdom. Steps taken during the calibration process to improve simulations of As sorption were ultimately detrimental to the predictive results, for example, and the sensitivity analysis failed to bracket observed metal concentrations.

  10. Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial.

    Science.gov (United States)

    Steele, Catriona M; Bayley, Mark A; Péladeau-Pigeon, Melanie; Stokely, Shauna L

    2013-05-07

    It is estimated that approximately 50% of stroke survivors will experience swallowing difficulty, or dysphagia. The associated sequelae of dysphagia include dehydration, malnutrition, and aspiration pneumonia, all of which have can have serious medical consequences. To improve swallowing safety and efficiency, alternative nutritional intake methods (for example, a feeding tube) or a modified diet texture (such as pureed foods or thickened liquids) may be recommended but these modifications may negatively affect quality of life. An alternative approach to treating dysphagia has emerged over the past few years, targeting stronger lingual muscles through maximal isometric pressure tasks. Although these studies have shown promising results, thin-liquid bolus control continues to be challenging for patients with dysphagia. Previous work investigating lingual pressures when healthy participants swallow has suggested that greater task specificity in lingual exercises may yield improved results with thin liquids. This is a small, exploratory randomized clinical trial being conducted with post-stroke patients 4 to 20 weeks after onset of dysphagia secondary to impaired lingual control. At enrollment, participants are randomly assigned to one of two treatment protocols, either tongue pressure profile training (TPPT) or the control treatment, tongue pressure strength-and-accuracy training (TPSAT). Each treatment protocol consists of 24 sessions of treatment over 8 to 12 weeks with monitoring of tongue pressure as well as a baseline and outcome videofluoroscopic swallowing study. Tongue pressure measures, videofluoroscopic measures, and functional outcome measures will be obtained following training of 60 participants (30 in each condition), to determine whether TPPT yields better outcomes. This study will continue to explore options beyond tube feeding and modified diets for people with neurogenic dysphagia following stroke. Should the novel protocol, TPPT, prove to be more

  11. Analysis of bedside entertainment services' effect on post cardiac surgery physical activity: a prospective, randomised clinical trial.

    Science.gov (United States)

    Papaspyros, Sotiris; Uppal, Shitansu; Khan, Shakeeb A; Paul, Sanjoy; O'Regan, David J

    2008-11-01

    A rising number of acute hospitals in the UK have been providing patients with bedside entertainment services (BES) since 1995. However, their effect on postoperative patient mobility has not been explored. The aim of this prospective randomised clinical trial was to compare the level of postoperative physical activity and length of in-hospital stay of patients undergoing cardiac surgery depending on whether they had access to BES or not. One hundred patients requiring elective cardiac surgery were randomised to receive access to BES (52 patients) or not (48 patients). Pedometers were used to quantify postoperative physical activity for 5 days. To assess the significance of the effect of intervention (TV off or on) on the pedometer counts over time a mixed effect Poisson regression model is used, with the time varying aspect as random component. The potential influence of gender difference and age on pedometer counts were assessed by incorporating these two factors as covariates in the Poisson model. On average, patients with no access to BES walked more than those with BES access. This difference ranged between 192 and 609 steps in favour of the first group for each individual postoperative day. Patients with no access to BES were 84% more likely (risk ratio: 1.84, 95% CI: 1.29-2.63) to walk higher number of steps than patients with access to BES. On average, participants with access to BES were likely to stay longer in hospital (median of 7 days with interquartile range 6-7 days), than participants with no access to BES (median of 6 days with interquartile range 5-7 days), however the difference did not reach statistical significance. We have demonstrated that the bedside entertainment systems may have an adverse effect on post cardiac surgery patient ambulation and may contribute to an increase in hospital stay.

  12. Carprofen provides better post-operative analgesia than tramadol in dogs after enucleation: A randomized, masked clinical trial

    Science.gov (United States)

    Delgado, Cherlene; Bentley, Ellison; Hetzel, Scott; Smith, Lesley J

    2015-01-01

    Objective To compare analgesia provided by carprofen or tramadol in dogs after enucleation. Design Randomized, masked trial Animals Forty-three dogs Procedures Client-owned dogs admitted for routine enucleation were randomly assigned to receive either carprofen or tramadol orally 2 hours prior to surgery and 12 hours after the first dose. Dogs were scored for pain at baseline, and postoperatively at 0.25, 0.5, 1, 2, 4, 6, 8, 24, and 30 hours after extubation. Dogs received identical premedication and inhalation anesthesia regimens, including premedication with hydromorphone. If the total pain score was ≥9, if there was a score ≥ 3 in any one category, or if the visual analog scale score (VAS) was ≥35 combined with a palpation score of >0, rescue analgesia (hydromorphone) was administered and treatment failure was recorded. Characteristics between groups were compared with a Student’s t-test and Fisher’s exact test. The incidence of rescue was compared between groups using a log rank test. Pain scores and VAS scores between groups were compared using repeated measures ANOVA. Results There was no difference in age (p=0.493), gender (p=0.366) or baseline pain scores (p=0.288) between groups. Significantly more dogs receiving tramadol required rescue analgesia (6/21) compared to dogs receiving carprofen (1/22; p=0.035). Pain and VAS scores decreased linearly over time (p=0.038, ppain (p=0.915) or VAS scores (p=0.372) between groups at any time point (dogs were excluded from analysis after rescue). Conclusions and Clinical Relevance This study suggests that carprofen, with opioid premedication, provides more effective post-operative analgesia than tramadol in dogs undergoing enucleation. PMID:25459482

  13. Evaluation of contributing factors of post transplant erythrocytosis in renal transplant patients

    International Nuclear Information System (INIS)

    Ahmed, S.; Ahmed, E.; Naqvi, R.; Qureshi, S.

    2012-01-01

    Objective: To evaluate the prevalence and contributing factors causing post transplant erythrocytosis in renal transplant patients. Methods: This retrospective study was conducted on live related renal transplant patients at SIUT. The records of all transplant recipients transplanted between April 2008 and December 2008 and who had at least 24 months follow up were studied. Patients in whom haematocrit exceeded 51% and those who received treatment for it were classified into post transplant erythrocytosis group. Results: Out of 200 renal transplant patients who had functioning graft at the time of analysis, 40 (20%) developed post transplant erythrocytosis (HCT >51%) after a mean interval of 9.5+- 2.5 months. Patients with erythrocytosis were mostly males (95% in PTE group vs 73.75% in non PTE group) ,had a shorter period on dialysis before undergoing renal transplantation (9.28 months in PTE group vs 14.56 months in non PTE group) and had relatively better graft function at the onset of erythrocytosis as judged by serum creatinine (S. Creatinine of 1.06+-0.29 mg/dl in PTE group vs 1.37 +- 0.51 mg/dl in non PTE group). No thrombotic complications were observed. All patients with erythrocytosis were treated with enalapril (ACE inhibitors) and 28 out of 40 required phlebotomy in addition to ACE inhibitors. The mean HCT at the time of last follow up in treated patients was 48.61+-1.85%. Conclusion: Post transplant erythrocytosis generally occurs in male patients with good graft function, thrombotic complications are of rare occurrence and response to ACE inhibitors is good. (author)

  14. Post-Flight Back Pain Following International Space Station Missions: Evaluation of Spaceflight Risk Factors

    Science.gov (United States)

    Laughlin, M. S.; Murray, J. D.; Wear, M. L.; Van Baalen, M.

    2016-01-01

    INTRODUCTION Back pain during spaceflight has often been attributed to the lengthening of the spinal column due to the absence of gravity during both short and long-duration missions. Upon landing and re-adaptation to gravity, the spinal column reverts back to its original length thereby causing some individuals to experience pain and muscular spasms, while others experience no ill effects. With International Space Station (ISS) missions, cases of back pain and injury are more common post-flight, but little is known about the potential risk factors. Thus, the purpose of this project was to perform an initial evaluation of reported post-flight back pain and injury cases to relevant spaceflight risk factors in United States astronauts that have completed an ISS mission. METHODS All US astronauts who completed an ISS mission between Expeditions (EXP) 1 and 41 (2000-2015) were included in this evaluation. Forty-five astronauts (36 males and 9 females) completed 50 ISS missions during the study time period, as 5 astronauts completed 2 ISS missions. Researchers queried medical records of the 45 astronauts for occurrences of back pain and injury. A case was defined as any reported event of back pain or injury to the cervical, thoracic, lumbar, sacral, or coccyx spine regions. Data sources for the cases included the Flight Medicine Clinic's electronic medical record; Astronaut Strength, Conditioning and Rehabilitation electronic documentation; the Private Medical Conference tool; and the Space Medicine Operations Team records. Post-flight cases were classified as an early case if reported within 45 days of landing (R + 45) or a late case if reported from R + 46 to R + 365 days after landing (R + 1y). Risk factors in the astronaut population for back pain include age, sex, prior military service, and prior history of back pain. Additionally, spaceflight specific risk factors such as type of landing vehicle and onboard exercise countermeasures were included to evaluate their

  15. Evaluating Intermittent Androgen-Deprivation Therapy Phase III Clinical Trials: The Devil Is in the Details.

    Science.gov (United States)

    Hussain, Maha; Tangen, Catherine; Higano, Celestia; Vogelzang, Nicholas; Thompson, Ian

    2016-01-20

    Intermittent androgen deprivation (IAD) has been widely tested in prostate cancer. However, phase III trials testing continuous androgen deprivation (CAD) versus IAD have reached inconclusive and seemingly contradictory results. Different design and conduct issues must be critically evaluated to better interpret the results. Seven published phase III trials were examined for prespecified design and outcomes. Treatment specifications; primary end point; superiority versus noninferiority design assumptions, including magnitude of assumed versus observed noninferiority margin (NIM); duration of follow-up; and quality-of-life (QOL) outcomes were considered in terms of the results and conclusions reported. Five trials had a superiority and three had a noninferiority primary hypothesis. Only three trials had a uniform population and overall survival (OS) end point. All trials observed better outcomes in terms of OS and progression-free survival (PFS) than assumed at time of study design, translating into prespecified NIMs or hazard ratios that reflected larger absolute differences in OS or PFS between arms. Lower-than-expected event rates also reduced statistical power for the trials. Other factors, including length of follow-up, cause of death, QOL, and primary end point, and their impact on trial interpretation are discussed. No trial to date has demonstrated survival superiority of IAD compared with CAD. Trials concluding IAD is noninferior to CAD were based on wide NIMs that included clinically important survival differences, not likely to be considered comparable by physicians or patients. Interim analyses relying on short follow-up and including a majority of non-prostate cancer deaths will favor a noninferiority conclusion and should be interpreted cautiously. Adequate follow-up is required to ensure capture of prostate cancer deaths in both superiority and noninferiority trials. © 2015 by American Society of Clinical Oncology.

  16. Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality.

    Science.gov (United States)

    Kistler, Kristin D; Xu, Yingxin; Zou, Kelly H; Ntanios, Fady; Chapman, Douglass S; Luo, Xuemei

    2018-01-01

    Overactive bladder (OAB) disproportionately affects older-aged adults, yet most randomized controlled trials (RCTs) underrepresent patients ≥65. This systematic literature review (SLR) identified RCTs evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly patients with OAB, and compared study quality across trials. MEDLINE ® , Embase ® , and Cochrane Collaboration Central Register of Clinical Trials databases were searched from inception through April 28, 2015 to identify published, peer-reviewed RCT reports evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly OAB patients (either ≥65 years or study-described as "elderly"). To assess study quality of RCT reports, we focused on internal/external validity, assessed via two scales: the validated Effective Public Health Practice Project [EPHPP]): Quality Assessment Tool for Quantitative Studies, and a tool commissioned by the Agency for Healthcare Research and Quality (AHRQ). Database searches yielded 1380 records that were then screened according to predefined inclusion/exclusion criteria. We included eight papers meeting study criteria. Despite scientific community efforts to improve RCT reporting standards, published reports still include incomplete and inconsistent reporting-of subject attrition, baseline patient characteristics, inclusion/exclusion criteria, and other important details. Only three of the eight OAB RCTs in this review received quality ratings of Strong (EPHPP) or Fair (AHRQ) and were multicenter with large samples. Despite the prevalence of OAB among older age individuals, relatively few RCTs evaluate OAB treatments explicitly among elderly subjects. The findings from this quality assessment suggest some areas for improvement in both conduct and reporting of future RCTs assessing OAB treatment in elderly. © 2017 Wiley Periodicals, Inc.

  17. Evaluation of the endodontic apical seal after post insertion by synchrotron radiation microtomography

    International Nuclear Information System (INIS)

    Contardo, L.; De Luca, M.; Biasotto, M.; Longo, R.; Olivo, A.; Pani, S.; Di Lenarda, R.

    2005-01-01

    The commonly used methods for evaluating the endodontic apical seal, such as longitudinal and transversal section and diaphanization, show some operative difficulties and intrinsic limitation. This study suggests and describes a new method of analysis using a synchrotron radiation microtomography to analyse the root apex after post insertion, creating a three-dimensional image and analysing sections of the specimen every 5μm. The study was performed at SYRMEP beam line at the Electra Synchrotron in Trieste using monochromatic X-rays of 32KeV. Eleven monoradicular teeth were prepared using NiTi GT Rotary files instruments to an apical size 20 with conicity .06 and divided in four groups: in G1 (n=4) and G2 (n=2), the specimens were endodontically filled with guttapercha and a zinc-oxide sealer, in G3 (n=3) and G4 (n=2) guttapercha and a silicon-based sealer were used. An endodontic post was inserted in specimens of groups 1 and 3 following the manufacturer's instructions. Specimens were analysed using monochromatic X-rays of 32KeV. A CCD detector with pixel dimension pf 5x5μm 2 was used for the acquisition process. Seven hundred and twenty projections were performed over 180 o range using a high-resolution rotator. The projections were reconstructed using standard algorithms for tomographic reconstruction. The apical infiltration was evaluated by verifying if black spots were detectable on the images. The specimens of groups 3 and 4 showed a better apical seal than the ones of groups 1 and 2. Post insertion, when a ZOE-based sealer is used, increases the apical gap even if it does not seem to be clinically relevant and sufficient to be a cause of endodontic failure. The new method for analysis appeared to be effective to detect small defects in endodontic obturation, analysing guttapercha-sealer and sealer-dentin interfaces

  18. Ex-post evaluation. Research independency of the basic science study of JAERI

    International Nuclear Information System (INIS)

    Yanagisawa, Kazuaki; Takahashi, Shoji

    2010-06-01

    A research independency was defined here as the continuity and the development of a corresponding research field with an evolution of history. The authors took three fields as research parameters for the ex-post evaluation. They were all belonged to the basic science field studied in the Japan Atomic Energy Research Institute (JAERI). The first parameter was actinides, which was situated in the center of research networking from the viewpoint of socio-economy. The second parameter was positron, which was situated in the periphery of research networking and the third one was neutron, which had competition with other research organizations in Japan. The three were supported and promoted financially by the JAERI. The target year was covered from 1978 to 2002, a 25-years. INIS (International Nuclear Information Systems) operated by the International Atomic Energy Agency (IAEA) was used as the tool for the present bibliometric study. It was revealed that important factors that led the sustainable success of the research independency were the constant efforts to accomplish their mission, the education of their successors to instructing the explicit and tacit research findings and the construction of intellectual networking with learned circles and industries, those were in good collaboration with JAERI. These were quantitatively clarified. Conversely, main factors that impeded the development of the research independency were discontinuance of research caused by a retirement, a change of post or that of occupation, and an unexpected accident (death) of the core researchers. Among three parameters, the authors confirmed that there occurred the time-dependent stage of germination, development and declination of the research independency attributing to the interaction between the succession factors and impeded factors. For this kind of ex-post evaluation, the support of field research laboratory was inevitable. (author)

  19. Structural effects of sprifermin in knee osteoarthritis: a post-hoc analysis on cartilage and non-cartilaginous tissue alterations in a randomized controlled trial.

    Science.gov (United States)

    Roemer, Frank W; Aydemir, Aida; Lohmander, Stefan; Crema, Michel D; Marra, Monica Dias; Muurahainen, Norma; Felson, David T; Eckstein, Felix; Guermazi, Ali

    2016-07-09

    A recent publication on efficacy of Sprifermin for knee osteoarthritis (OA) using quantitatively MRI-defined central medial tibio-femoral compartment cartilage thickness as the structural primary endpoint reported no statistically significant dose response. However, Sprifermin was associated with statistically significant, dose-dependent reductions in loss of total and lateral tibio-femoral cartilage thickness. Based on these preliminary promising data a post-hoc analysis of secondary assessment and endpoints was performed to evaluate potential effects of Sprifermin on semi-quantitatively evaluated structural MRI parameters. Aim of the present analysis was to determine effects of sprifermin on several knee joint tissues over a 12 month period. 1.5 T or 3 T MRIs were acquired at baseline and 12 months follow-up using a standard protocol. MRIs were read according to the Whole-Organ Magnetic Resonance Imaging Score (WORMS) scoring system (in 14 articular subregions) by four muskuloskeletal radiologists independently. Analyses focused on semiquantitative changes in the 100 μg subgroup and matching placebo of multiple MRI-defined structural alterations. Analyses included a delta-subregional and delta-sum approach for the whole knee and the medial and lateral tibio-femoral (MTFJ, LTFJ), and patello-femoral (PFJ) compartments, taking into account number of subregions showing no change, improvement or worsening and changes in the sum of subregional scores. Mann-Whitney - Wilcoxon tests assessed differences between groups. Fifty-seven and 18 patients were included in the treatment and matched placebo subgroups. Less worsening of cartilage damage was observed from baseline to 12 months in the PFJ (0.02, 95 % confidence interval (CI) (-0.04, 0.08) vs. placebo 0.22, 95 % CI (-0.05, 0.49), p = 0.046). For bone marrow lesions (BMLs), more improvement was observed from 6 to 12 months for whole knee analyses (-0.14, 95 % CI (-0.48, 0.19) vs. placebo 0.44, 95

  20. Health-economic evaluation in implant trials: design considerations.

    Science.gov (United States)

    Alt, Volker; Pavlidis, Theodoros; Szalay, Gabor; Heiss, Christian; Schnettler, Reinhard

    2009-01-01

    In today's world, demonstration of the safety, efficacy, and quality of a new treatment strategy is no longer sufficient in many countries for market entry and reimbursement in the public healthcare system. This implies that new implants in orthopedic and orthopedic trauma surgery not only must be shown to lead to better medical outcome compared with the standard of care implant, but also must be shown to exhibit "good value" for the money for the public health-care system based on sound economic data from health-economic studies. The purpose of this article is to elucidate a framework for health-economic aspects alongside implant trials, with the assumption that the new implant is more costly but potentially better than the control implant. Cost-effectiveness, cost-utility, and cost-benefit studies are suitable for the assessment of the health-economic value of a new implant. The following criteria should be considered for a health-economic study design in the context with an implant: i) it should state medical benefits of the new implant compared with the control implant; ii) it should precise the type of health economic study; iii) it should define the methodological approach, perspective of the study, and types of costs; iv) if necessary, it should state discount costs and/benefits; and v) a sound sensitivity analysis should be included. Furthermore, close cooperation between researchers, clinicians, and health economists is essential.

  1. Adalimumab for treating childhood plaque psoriasis: a clinical trial evaluation.

    Science.gov (United States)

    Di Lernia, Vito

    2017-12-01

    Most systemic therapies have not been systematically investigated in moderate to severe childhood plaque psoriasis. Evidence on the efficacy and safety of systemic treatments is limited and therapeutic guidelines are lacking. Recently adalimumab, a fully human monoclonal antibody that binds tumor necrosis factor (TNF)- alpha, was investigated in childhood psoriasis. Adalimumab is licensed for many inflammatory conditions including chronic plaque psoriasis in adults. Areas covered: A randomized phase III study published provided favourable efficacy and safety data of adalimumab in childhood psoriasis. The active comparator was methotrexate. After 16 weeks of treatment, a PASI 75 score was achieved in 58% of patients within the adalimumab 0.8 mg/kg group compared with 32% of patients within the methotrexate group. Safety data gave no evidence of drug-related serious adverse events and no organ toxicity. This is the first randomised controlled study of either adalimumab or methotrexate in children and adolescents with psoriasis. Expert opinion: The aforementioned trial was the first to provide clinical data on adalimumab's efficacy and safety in the short term when treating children and adolescents with psoriasis. Through the use of an active comparator, this study has opened the way for the future assessment of systemic therapies in children and adolescent with this condition.

  2. Evaluation of human health risk from in situ recovery uranium mining, pre-and post-mining, and post-restoration

    Energy Technology Data Exchange (ETDEWEB)

    Ruedig, E.; Bhattacharyya, A.; Borch, T.; Johnson, T. [Colorado State University (United States); Till, J. [Risk Assessment Corporation (United States)

    2014-07-01

    In the United States, the restoration of in situ recovery (ISR) uranium mines is aimed at returning sites to pre-mining conditions. While this may seem an appropriate goal, little or no scientific information is available to justify utilizing baseline conditions for regulatory compliance. The chemical and radiological contaminants monitored for restoration compliance have not been evaluated to ensure they are proper indicators of the mitigation of risk. Pre-mining aquifers do not meet minimum United States drinking water standards, and must have an aquifer exemption in place prior to mining. Under these conditions, returning groundwater to near the original concentrations of contaminants may be unnecessary. Post-mining groundwater is also unlikely to meet standards for drinking water, but may be depleted in at least some toxic species as a result of the mining process. Here, we examine the risk to representative person from the personal use of groundwater sourced from an Uranium ISR mine. Water samples were collected from Cameco Resource's Smith Ranch-Highlands ISR Uranium mine near Casper, Wyoming, USA. Samples were acquired pre-mining, post-mining, and post-restoration. Concentrations of heavy metals and radionuclides were assessed by appropriate analytical techniques (e.g., mass spectroscopy or alpha spectroscopy) and these concentrations were used to estimate human health risk for three exposure scenarios: a scenario with high exposure, a scenario with medium exposure, and a scenario with low exposure. A simple biosphere transport model was constructed for each scenario to estimate the risk to humans from the use of contaminated waters for subsistence-related activities. Chemical and radiological risks were harmonized according to the United States Environmental Protection Agency's guidance for superfund sites. Each exposure scenario and its subsequent risk were evaluated individually for pre-mining, post-mining, and post-restoration aquifer waters

  3. EVALUATION OF PRE AND POST TRAINING PRACTICES REGARDING MANAGEMENT OF DIABETES

    Directory of Open Access Journals (Sweden)

    M Mohanty

    1995-09-01

    Full Text Available The study was conducted on 112 diabetic patients in S.S. Hospital.Varanasi to evaluate the pre- and post- training practices regarding management of Diabetes mellitus. A pre-tested structured respondent schedule urn used to collect information regarding the socio-economic status and some of the managerial aspects of the disease by questionaire cum interview method. Education cum training was imparted to all the respondents in the first three months and in the fourth month evaluation programme was carried out and their level ofpractive regarding different aspects of diabetic management were assessed by using seven point score method. It was found that training was proved effective for the aspect "Physical exer­cise" and "Restricted diet" but slight improvement in the practive score was seen in "Precaution in Special Hygienic Condition" aspects. So. con­tinuous education programme was needed to improve their practice rate.

  4. Institutionalising and streamlining development monitoring and evaluation in post-revolutionary Egypt: A readiness primer

    Directory of Open Access Journals (Sweden)

    Laila El Baradei

    2014-12-01

    Full Text Available This research provides first-hand information about the field of development monitoring and evaluation (DME in Egypt post the 2011 revolution. There is a great need for more effective, informative DME to hold government and development partners accountable for results achieved and meet people’s needs and expectations. Both online and offline interviews were conducted with a purposive sample of 61 representatives of different stakeholder groups working in the field of DME in Egypt. Findings pointed to a lack of interest and understanding of DME, difficulty with accessing data required for satisfactory evaluation and the perceived limited effect of DME work on public policy making. Respondents’ recommendations for enhanced performance included the presence of DME units in all government and NGO programmes, more intensive training to all parties concerned, creation of an umbrella DME agency, allocating of a sufficient budget and advocating for the cause.

  5. Evaluation of Mechanical Properties of Glass Fiber Posts Subjected to Laser Surface Treatments.

    Science.gov (United States)

    Barbosa Siqueira, Carolina; Spadini de Faria, Natália; Raucci-Neto, Walter; Colucci, Vivian; Alves Gomes, Erica

    2016-10-01

    The aim of this study was to evaluate the influence of laser irradiation on flexural strength, elastic modulus, and surface roughness and morphology of glass fiber posts (GFPs). Laser treatment of GFPs has been introduced to improve its adhesion properties. A total of 40 GFPs were divided into 4 groups according to the irradiation protocol: GC-no irradiation, GYAG-irradiation with erbium:yttrium-aluminum-garnet [Er:YAG], GCR-irradiation with erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG), and GDI-irradiation with diode laser. The GFP roughness and morphology were evaluated through laser confocal microscopy before and after surface treatment. Three-point bending flexural test measured flexural strength and elastic modulus. Data about elastic modulus and flexural strength were subjected to one-way ANOVA and Bonferroni test (p properties of GFPs.

  6. Impression management during evaluation and psychological reactions post-donation of living kidney donors.

    Science.gov (United States)

    Hildebrand, Lee; Melchert, Timothy P; Anderson, Rebecca C

    2014-08-01

    Many healthcare providers have been concerned about the extent to which potential kidney donors use impression management or concealment of important information regarding their medical history, current functioning, or other circumstances that could affect whether they are accepted as donors. To date, however, there has been very little empirical examination of these questions. It is also not known whether donors' use of impression management pre-donation is related to their reactions and adjustment post-donation. This study surveyed 76 individuals who had donated a kidney one to six yr previously regarding their use of impression management and their concealing of information during their psychological evaluations. They were also asked about their reactions to the donation and whether they would make the same decision again. In addition, 21 of these donors participated in focus groups that explored these questions in depth. Many of the kidney donors reported that they possessed very strong motivation to donate and consequently used impression management in their interactions with medical professionals pre-donation. Very few donors, however, indicated that they concealed information during their pre-donation evaluations. The donors' psychological reactions post-donation were generally positive, and nearly all indicated that they would make the same decision again. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Music therapy for prisoners: pilot randomised controlled trial and implications for evaluating psychosocial interventions.

    Science.gov (United States)

    Gold, Christian; Assmus, Jörg; Hjørnevik, Kjetil; Qvale, Liv Gunnhild; Brown, Fiona Kirkwood; Hansen, Anita Lill; Waage, Leif; Stige, Brynjulf

    2014-12-01

    Mental health problems are common among prison inmates. Music therapy has been shown to reduce mental health problems. It may also be beneficial in the rehabilitation of prisoners, but rigorous outcome research is lacking. We compared group music therapy with standard care for prisoners in a pilot randomised controlled trial that started with the establishment of music therapy services in a prison near Bergen in 2008. In all, 113 prisoners agreed to participate. Anxiety (STAI-State [State-Trait Anxiety Inventory], STAI-Trait), depression (HADS-D [Hospital Anxiety and Depression Scale]), and social relationships (Quality of Life Enjoyment and Satisfaction Questionnaire [Q-LES-Q]) were assessed at baseline; every 2 weeks in the experimental group; after 1, 3, and 6 months in the control group; and at release. No restrictions were placed on the frequency, duration, or contents of music therapy. Duration of stay in the institution was short (62% stayed less than 1 month). Only a minority reached clinical cutoffs for anxiety and depression at baseline. Between-group analyses of effects were not possible. Music therapy was well accepted and attractive among the prisoners. Post hoc analysis of within-group changes suggested a reduction of state anxiety after 2 weeks of music therapy (d = 0.33, p = .025). Short sentences and low baseline levels of psychological disturbance impeded the examination of effects in this study. Recommendations for planning future studies are given, concerning the careful choice of participants, interventions and settings, comparison condition and design aspects, choice of outcomes, and integration of research approaches. Thus, the present study has important implications for future studies evaluating interventions for improving prisoners' mental health. ISRCTN22518605. © The Author(s) 2013.

  8. Healthy Foundations Study: a randomised controlled trial to evaluate biological embedding of early-life experiences.

    Science.gov (United States)

    Gonzalez, Andrea; Catherine, Nicole; Boyle, Michael; Jack, Susan M; Atkinson, Leslie; Kobor, Michael; Sheehan, Debbie; Tonmyr, Lil; Waddell, Charlotte; MacMillan, Harriet L

    2018-01-26

    Adverse early experiences are associated with long-lasting disruptions in physiology, development and health. These experiences may be 'biologically embedded' into molecular and genomic systems that determine later expressions of vulnerability. Most studies to date have not examined whether preventive interventions can potentially reverse biological embedding. The Nurse-Family Partnership (NFP) is an evidence-based intervention with demonstrated efficacy in improving prenatal health, parenting and child functioning. The Healthy Foundations Study is an innovative birth cohort which will evaluate the impact of the NFP on biological outcomes of mothers and their infants. Starting in 2013, up to 400 pregnant mothers and their newborns were recruited from the British Columbia Healthy Connections Project-a randomised controlled trial of the NFP, and will be followed to child aged 2 years. Women were recruited prior to 28 weeks' gestation and then individually randomised to receive existing services (comparison group) or NFP plus existing services (intervention group). Hair samples are collected from mothers at baseline and 2 months post partum to measure physiological stress. Saliva samples are collected from infants during all visits for analyses of stress and immune function. Buccal swabs are collected from infants at 2 and 24 months to assess DNA methylation. Biological samples will be related to child outcome measures at age 2 years. The study received ethical approval from seven research ethics boards. Findings from this study will be shared broadly with the research community through peer-reviewed publications, and conference presentations, as well as seminars with our policy partners and relevant healthcare providers. The outcomes of this study will provide all stakeholders with important information regarding how early adversity may lead to health and behavioural disparities and how these may be altered through early interventions. NCT01672060; Pre-results.

  9. [Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

    Science.gov (United States)

    Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

    2013-09-01

    Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

  10. The intervention process in the European Fans in Training (EuroFIT) trial: a mixed method protocol for evaluation.

    Science.gov (United States)

    van de Glind, I; Bunn, C; Gray, C M; Hunt, K; Andersen, E; Jelsma, J; Morgan, H; Pereira, H; Roberts, G; Rooksby, J; Røynesdal, Ø; Silva, M; Sorensen, M; Treweek, S; van Achterberg, T; van der Ploeg, H; van Nassau, F; Nijhuis-van der Sanden, M; Wyke, S

    2017-07-27

    EuroFIT is a gender-sensitised, health and lifestyle program targeting physical activity, sedentary time and dietary behaviours in men. The delivery of the program in football clubs, led by the clubs' community coaches, is designed to both attract and engage men in lifestyle change through an interest in football or loyalty to the club they support. The EuroFIT program will be evaluated in a multicentre pragmatic randomised controlled trial (RCT), for which ~1000 overweight men, aged 30-65 years, will be recruited in 15 top professional football clubs in the Netherlands, Norway, Portugal and the UK. The process evaluation is designed to investigate how implementation within the RCT is achieved in the various football clubs and countries and the processes through which EuroFIT affects outcomes. This mixed methods evaluation is guided by the Medical Research Council (MRC) guidance for conducting process evaluations of complex interventions. Data will be collected in the intervention arm of the EuroFIT trial through: participant questionnaires (n = 500); attendance sheets and coach logs (n = 360); observations of sessions (n = 30); coach questionnaires (n = 30); usage logs from a novel device for self-monitoring physical activity and non-sedentary behaviour (SitFIT); an app-based game to promote social support for physical activity outside program sessions (MatchFIT); interviews with coaches (n = 15); football club representatives (n = 15); and focus groups with participants (n = 30). Written standard operating procedures are used to ensure quality and consistency in data collection and analysis across the participating countries. Data will be analysed thematically within datasets and overall synthesis of findings will address the processes through which the program is implemented in various countries and clubs and through which it affects outcomes, with careful attention to the context of the football club. The process evaluation will

  11. 'Beyond Milestones': a randomised controlled trial evaluating an innovative digital resource teaching quality observation of normal child development.

    Science.gov (United States)

    Connolly, Anne M; Cunningham, Clare; Sinclair, Adriane J; Rao, Arjun; Lonergan, Amy; Bye, Ann M E

    2014-05-01

    The study aimed to create and evaluate the educational effectiveness of a digital resource instructing paediatric trainees in a systematic approach to critical and quality observation of normal child development. A digital educational resource was developed utilising the skills of an expert developmental paediatrician who was videoed assessing normal early child development at a series of critical stages. Videos illustrated aspects of language, sophistication of play and socialisation, cognition, and motor progress. Expert commentary, teaching text and summaries were used. A randomised controlled trial evaluated the resource. Paediatric trainees were recruited from The Sydney Children's Hospitals Network. Outcome measures were repeated at three time points (pre-teaching, immediate-post and 1 month) and included self-rated attitudes, knowledge of markers of development and observational expertise. Qualitative data on teaching usefulness were obtained through open-ended questions. Fifty-six paediatric trainees (registrar 79%, women 82%; mean age 31 years) completed the pre-assessment, 46 the immediate-post and 45 the 1-month follow-up (20% attrition). Compared with the Control group, the Teaching group scored higher over time on markers of development (P = 0.006), observational expertise (P improves knowledge, increases confidence and is useful, providing a structured approach to developmental assessment. The techniques taught can be applied to every paediatric consultation. © 2013 The Authors. Journal of Paediatrics and Child Health © 2013 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  12. The influence of repeated abutment changes on peri-implant tissue stability: 3-year post-loading results from a multicentre randomised controlled trial.

    Science.gov (United States)

    Bressan, Eriberto; Grusovin, Maria Gabriella; D'Avenia, Ferdinando; Neumann, Konrad; Sbricoli, Luca; Luongo, Giuseppe; Esposito, Marco

    increased marginal bone loss (difference = 0.1 mm, CI 95%: -0.3, 0.5, P = 0.590) or buccal recessions (difference = 0.1 mm, CI 95%: -0.4, 0.7, P = 0.674) at implants with less than 2 mm of keratinised mucosa at loading. Three-year post-loading data showed that repeated abutment disconnections significantly increased bone loss of 0.43 mm, but this difference may not be considered clinically relevant; therefore clinicians can use the procedure they find more convenient for each specific patient. Immediately non-occlusally loaded dental implants are a viable alternative to conventional loading and no increased bone loss or buccal recessions were noticed at implants with less than 2 mm of keratinised mucosa. Conflict of interest statement: This trial was partially funded by Dentsply Sirona Implants, the manufacturer of the implants and other products evaluated in this investigation. However, data belonged to the authors and by no means did the manufacturer interfere with the conduct of the trial or the publication of the results, with the exception of rejecting a proposal to change the protocol, after the trial was started, allowing the use of indexed abutments.

  13. Trial and evaluation of assertion training involving nursing students.

    Science.gov (United States)

    Nishina, Yuko; Tanigaki, Shizuko

    2013-09-01

    The concept of assertion and conceptual/practical methods of assertion (assertiveness) training were originally developed in the United States and Europe. These principles were embraced and adapted in Japan in 1970's. However, only a few studies relating to assertion (assertiveness) have been undertaken thus far in Japan, especially so in the domain of nursing students in comparison with other countries. The purpose of this study was to design and implement assertion training with nursing students and to clarify its effects. The participants were all volunteers, invited from a class of 3rd year nursing students. Ten students (intervention group) participated in the assertion training comprised of five sessions in February 2006. Fifty-six students (control group) were participated only in the questionnaire. Both groups were asked to complete the same questionnaire twice, before and after the assertion training. The questionnaire measured levels of assertiveness, social skills, self-esteem, social support and satisfaction with university life. The results and variances, both before and after assertion training, between the intervention group and the control group were analyzed. The effectiveness of the assertion training was determined by changes in pre and post training questionnaire scores. The scores for social skills in the control group had a tendency to decline while the scores for social skills in the intervention group remained constant. Although there were no statistically significant results in the intervention group, the present study highlights areas appropriate for further study.

  14. Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT

    Directory of Open Access Journals (Sweden)

    Julie A Luker

    2016-05-01

    Full Text Available Abstract Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT. Methods A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Results Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to ‘get staff on board’, and developing different ways of working. Conclusions The AVERT stroke rehabilitation trial required commitment to deliver

  15. A pilot randomised clinical trial of physiotherapy (manual therapy, exercise, and education) for early-onset hip osteoarthritis post-hip arthroscopy.

    Science.gov (United States)

    Kemp, Joanne; Moore, Kate; Fransen, Marlene; Russell, Trevor; Freke, Matthew; Crossley, Kay M

    2018-01-01

    Despite the increasing use of hip arthroscopy for hip pain, there is no level 1 evidence to support physiotherapy rehabilitation programs following this procedure. The aims of this study were to determine (i) what is the feasibility of a randomised controlled trial (RCT) investigating a targeted physiotherapy intervention for early-onset hip osteoarthritis (OA) post-hip arthroscopy? and (ii) what are the within-group treatment effects of the physiotherapy intervention and a health-education control group? This study was a pilot single-blind RCT conducted in a private physiotherapy clinic in Hobart, Australia. Patients included 17 volunteers (nine women; age 32 ± 8 years; body mass index = 25.6 ± 5.1 kg/m 2 ) who were recruited 4-14 months post-hip arthroscopy, with chondropathy and/or labral pathology at the time of surgery. Interventions included a physiotherapy treatment program that was semi-standardised and consisted of (i) manual therapy; (ii) hip strengthening and functional retraining; and (iii) health education. Control treatment encompassed individualised health education sessions. The primary outcome measure was feasibility, which was reported as percentage of eligible participants enrolled, adherence with the intervention, and losses to follow-up. The research process was evaluated using interviews, and an estimated sample size for a definitive study is offered. Secondary outcomes included the Hip disability and Osteoarthritis Outcome Score (HOOS) and the International Hip Outcome Tool (IHOT-33) patient-reported outcomes. Seventeen out of 48 eligible patients (35%) were randomised. Adherence to the intervention was 100%, with no losses to follow-up. The estimated sample size for a full-scale RCT was 142 patients. The within-group (95% confidence intervals) change scores for the physiotherapy group were HOOS-Symptoms 6 points (-4 to 16); HOOS-Pain 10 points (-2 to 22); HOOS-Activity of Daily Living 8 points (0 to 16); HOOS-Sport 3 points

  16. The impact of a pulmonary recruitment maneuver to reduce post-laparoscopic shoulder pain: A randomized controlled trial.

    Science.gov (United States)

    Ryu, Kyoungho; Choi, Wonjun; Shim, Jaegeum; Song, Taejong

    2017-01-01

    A pulmonary recruitment maneuver (PRM) can effectively reduce post-laparoscopic shoulder pain (PLSP). However, a high-pressure PRM may cause pulmonary barotrauma. This study aimed to evaluate the efficacy and safety of a PRM using two different maximum inspiratory pressures (40 and 60cmH 2 O) for reducing PLSP. Patients undergoing gynecologic laparoscopy were randomly allocated to a control group (n=30), a 40 cmH 2 O PRM group (n=30), and a 60 cmH 2 O PRM group (n=30). In the control group, residual carbon dioxide was removed by passive exsufflation through the port site. In the two intervention groups, the PRM consisting of five manual pulmonary inflations was performed at the end of surgery with a maximum pressure of 40 cmH 2 O or 60 cmH 2 O, respectively. Shoulder pain and wound pain were recorded using a visual analogue scale at 24 and 48h postoperatively. Wound pain scores at 24 and 48h post-surgery were not different between the three groups. The PLSP scores in the two intervention groups were significantly lower than that seen in the control group at 24 and 48h postoperatively (P=0.006 and P<0.001, respectively). However, there were no statistically significant differences in the PLSP scores between the two intervention groups. A low-pressure PRM (40cmH 2 O) is as effective as a high-pressure PRM (60cmH 2 O) for removing residual gas from the peritoneal cavity. PRM using a maximal inspiratory pressure of 40cmH 2 O is safe and efficacious for the reduction of PLSP. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  17. Impact of copula directional specification on multi-trial evaluation of surrogate endpoints

    Science.gov (United States)

    Renfro, Lindsay A.; Shang, Hongwei; Sargent, Daniel J.

    2014-01-01

    Evaluation of surrogate endpoints using patient-level data from multiple trials is the gold standard, where multi-trial copula models are used to quantify both patient-level and trial-level surrogacy. While limited consideration has been given in the literature to copula choice (e.g., Clayton), no prior consideration has been given to direction of implementation (via survival versus distribution functions). We demonstrate that evenwith the “correct” copula family, directional misspecification leads to biased estimates of patient-level and trial-level surrogacy. We illustrate with a simulation study and a re-analysis of disease-free survival as a surrogate for overall survival in early stage colon cancer. PMID:24905465

  18. [Evaluation of Web-based software applications for administrating and organising an ophthalmological clinical trial site].

    Science.gov (United States)

    Kortüm, K; Reznicek, L; Leicht, S; Ulbig, M; Wolf, A

    2013-07-01

    The importance and complexity of clinical trials is continuously increasing, especially in innovative specialties like ophthalmology. Therefore an efficient clinical trial site organisational structure is essential. In modern internet times, this can be accomplished by web-based applications. In total, 3 software applications (Vibe on Prem, Sharepoint and open source software) were evaluated in a clinical trial site in ophthalmology. Assessment criteria were set; they were: reliability, easiness of administration, usability, scheduling, task list, knowledge management, operating costs and worldwide availability. Vibe on Prem customised by the local university met the assessment criteria best. Other applications were not as strong. By introducing a web-based application for administrating and organising an ophthalmological trial site, studies can be conducted in a more efficient and reliable manner. Georg Thieme Verlag KG Stuttgart · New York.

  19. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records : evaluations of two exemplar trials

    NARCIS (Netherlands)

    van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam

    BACKGROUND: Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES: To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify

  20. Characterization and evaluation of controls on post-fire streamflow response across western US watersheds

    Science.gov (United States)

    Saxe, Samuel; Hogue, Terri S.; Hay, Lauren

    2018-02-01

    This research investigates the impact of wildfires on watershed flow regimes, specifically focusing on evaluation of fire events within specified hydroclimatic regions in the western United States, and evaluating the impact of climate and geophysical variables on response. Eighty-two watersheds were identified with at least 10 years of continuous pre-fire daily streamflow records and 5 years of continuous post-fire daily flow records. Percent change in annual runoff ratio, low flows, high flows, peak flows, number of zero flow days, baseflow index, and Richards-Baker flashiness index were calculated for each watershed using pre- and post-fire periods. Independent variables were identified for each watershed and fire event, including topographic, vegetation, climate, burn severity, percent area burned, and soils data. Results show that low flows, high flows, and peak flows increase in the first 2 years following a wildfire and decrease over time. Relative response was used to scale response variables with the respective percent area of watershed burned in order to compare regional differences in watershed response. To account for variability in precipitation events, runoff ratio was used to compare runoff directly to PRISM precipitation estimates. To account for regional differences in climate patterns, watersheds were divided into nine regions, or clusters, through k-means clustering using climate data, and regression models were produced for watersheds grouped by total area burned. Watersheds in Cluster 9 (eastern California, western Nevada, Oregon) demonstrate a small negative response to observed flow regimes after fire. Cluster 8 watersheds (coastal California) display the greatest flow responses, typically within the first year following wildfire. Most other watersheds show a positive mean relative response. In addition, simple regression models show low correlation between percent watershed burned and streamflow response, implying that other watershed factors

  1. Characterization and evaluation of controls on post-fire streamflow response across western US watersheds

    Directory of Open Access Journals (Sweden)

    S. Saxe

    2018-02-01

    Full Text Available This research investigates the impact of wildfires on watershed flow regimes, specifically focusing on evaluation of fire events within specified hydroclimatic regions in the western United States, and evaluating the impact of climate and geophysical variables on response. Eighty-two watersheds were identified with at least 10 years of continuous pre-fire daily streamflow records and 5 years of continuous post-fire daily flow records. Percent change in annual runoff ratio, low flows, high flows, peak flows, number of zero flow days, baseflow index, and Richards–Baker flashiness index were calculated for each watershed using pre- and post-fire periods. Independent variables were identified for each watershed and fire event, including topographic, vegetation, climate, burn severity, percent area burned, and soils data. Results show that low flows, high flows, and peak flows increase in the first 2 years following a wildfire and decrease over time. Relative response was used to scale response variables with the respective percent area of watershed burned in order to compare regional differences in watershed response. To account for variability in precipitation events, runoff ratio was used to compare runoff directly to PRISM precipitation estimates. To account for regional differences in climate patterns, watersheds were divided into nine regions, or clusters, through k-means clustering using climate data, and regression models were produced for watersheds grouped by total area burned. Watersheds in Cluster 9 (eastern California, western Nevada, Oregon demonstrate a small negative response to observed flow regimes after fire. Cluster 8 watersheds (coastal California display the greatest flow responses, typically within the first year following wildfire. Most other watersheds show a positive mean relative response. In addition, simple regression models show low correlation between percent watershed burned and streamflow response, implying that

  2. Selective serotonin reuptake inhibitors (SSRIs) for post-partum depression (PPD): a systematic review of randomized clinical trials.

    Science.gov (United States)

    De Crescenzo, Franco; Perelli, Federica; Armando, Marco; Vicari, Stefano

    2014-01-01

    The treatment of postpartum depression with selective serotonin reuptake inhibitors (SSRIs) has been claimed to be both efficacious and well tolerated, but no recent systematic reviews have been conducted. A qualitative systematic review of randomized clinical trials on women with postpartum depression comparing SSRIs to placebo and/or other treatments was performed. A comprehensive literature search of online databases, the bibliographies of published articles and grey literature were conducted. Data on efficacy, acceptability and tolerability were extracted and the quality of the trials was assessed. Six randomised clinical trials, comprising 595 patients, met quality criteria for inclusion in the analysis. Cognitive-behavioural intervention, psychosocial community-based intervention, psychodynamic therapy, cognitive behavioural therapy, a second-generation tricyclic antidepressant and placebo were used as comparisons. All studies demonstrated higher response and remission rates among those treated with SSRIs and greater mean changes on depression scales, although findings were not always statistically significant. Dropout rates were high in three of the trials but similar among treatment and comparison groups. In general, SSRIs were well tolerated and trial quality was good. There are few trials, patients included in the trials were not representative of all patients with postpartum depression, dropout rates in three trials were high, and long-term efficacy and tolerability were assessed in only two trials. SSRIs appear to be efficacious and well tolerated in the treatment of postpartum depression, but the available evidence fails to demonstrate a clear superiority over other treatments. © 2013 Elsevier B.V. All rights reserved.

  3. Cognitive therapy as an early treatment for post-traumatic stress disorder in children and adolescents: a randomized controlled trial addressing preliminary efficacy and mechanisms of action.

    Science.gov (United States)

    Meiser-Stedman, Richard; Smith, Patrick; McKinnon, Anna; Dixon, Clare; Trickey, David; Ehlers, Anke; Clark, David M; Boyle, Adrian; Watson, Peter; Goodyer, Ian; Dalgleish, Tim

    2017-05-01

    Few efficacious early treatments for post-traumatic stress disorder (PTSD) in children and adolescents exist. Previous trials have intervened within the first month post-trauma and focused on secondary prevention of later post-traumatic stress; however, considerable natural recovery may still occur up to 6-months post-trauma. No trials have addressed the early treatment of established PTSD (i.e. 2- to 6-months post-trauma). Twenty-nine youth (8-17 years) with PTSD (according to age-appropriate DSM-IV or ICD-10 diagnostic criteria) after a single-event trauma in the previous 2-6 months were randomly allocated to Cognitive Therapy for PTSD (CT-PTSD; n = 14) or waiting list (WL; n = 15) for 10 weeks. Significantly more participants were free of PTSD after CT-PTSD (71%) than WL (27%) at posttreatment (intent-to-treat, 95% CI for difference .04-.71). CT-PTSD yielded greater improvement on child-report questionnaire measures of PTSD, depression and anxiety; clinician-rated functioning; and parent-reported outcomes. Recovery after CT-PTSD was maintained at 6- and 12-month posttreatment. Beneficial effects of CT-PTSD were mediated through changes in appraisals and safety-seeking behaviours, as predicted by cognitive models of PTSD. CT-PTSD was considered acceptable on the basis of low dropout and high treatment credibility and therapist alliance ratings. This trial provides preliminary support for the efficacy and acceptability of CT-PTSD as an early treatment for PTSD in youth. Moreover, the trial did not support the extension of 'watchful waiting' into the 2- to 6-month post-trauma window, as significant improvements in the WL arm (particularly in terms of functioning and depression) were not observed. Replication in larger samples is needed, but attention to recruitment issues will be required. © 2016 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

  4. The impact of early outcome events on the effect of tranexamic acid in post-partum haemorrhage: an exploratory subgroup analysis of the WOMAN trial.

    Science.gov (United States)

    Brenner, Amy; Shakur-Still, Haleema; Chaudhri, Rizwana; Fawole, Bukola; Arulkumaran, Sabaratnam; Roberts, Ian

    2018-06-07

    In severe post-partum haemorrhage, death can occur within hours of bleeding onset so interventions to control the bleeding must be given immediately. In clinical trials of treatments for life-threatening bleeding, established treatments are given priority and the trial treatment is usually given last. However, enrolling patients in whom severe maternal morbidity or death is imminent or inevitable at the time of randomisation may dilute the effects of a trial treatment. We conducted an exploratory analysis of data from the WOMAN trial, an international, randomised placebo-controlled trial of the effects of tranexamic acid on death and surgical intervention in 20,060 women with post-partum haemorrhage. We assessed the impact of early maternal death or hysterectomy due to exsanguination on the effect of tranexamic acid on each of these respective outcomes. We conducted repeated analyses excluding patients with these outcomes at increasing intervals from the time of randomisation. We quantified treatment effects using risk ratios (RR) and 99% confidence intervals (CI) and prepared cumulative failure plots. Among 14,923 women randomised within 3 h of delivery (7518 tranexamic acid and 7405 placebo), there were 216 bleeding deaths (1.5%) and 383 hysterectomies due to bleeding (2.8%). After excluding deaths from exsanguination at increasing time intervals following randomization, there was a significant reduction in the risk of death due to bleeding with tranexamic acid (RR = 0.41; 99% CI 0.19-0.89). However, after excluding hysterectomies at increasing time intervals post-randomization, there was no reduction in the risk of hysterectomy due to bleeding with tranexamic acid (RR = 0.79; 99% CI 0.33-1.86). Findings from this analysis provide further evidence that tranexamic acid reduces the risk of death from exsanguination in women who experience postpartum haemorrhage. It is uncertain whether tranexamic acid reduces the risk of hysterectomy for bleeding after

  5. Evaluation of Post-Trial Reviews of Courts-Martial within the Department of the Navy

    Science.gov (United States)

    2010-12-10

    Reserve judges use "flex drills" (roughly equivalent to telecommuting ) to review many appellate cases submitted for adjudication. These cases are mostly...significant stress " was evident in the Region Legal Service Office commands and was "especially acute" in field commands that were “operational or joint...Deployments and increased judge advocate requirements for which authorizations do not exist have imposed additional stress . The upcoming Section

  6. Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

    DEFF Research Database (Denmark)

    Lifson, A; Rhame, F; Bellosa, W

    2006-01-01

    adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...

  7. Evaluating the impact of a quality management intervention on post-abortion contraceptive uptake in private sector clinics in western Kenya: a pre- and post-intervention study.

    Science.gov (United States)

    Wendot, Susy; Scott, Rachel H; Nafula, Inviolata; Theuri, Isaac; Ikiugu, Edward; Footman, Katharine

    2018-01-19

    Integration of family planning counselling and method provision into safe abortion services is a key component of quality abortion care. Numerous barriers to post-abortion family planning (PAFP) uptake exist. This study aimed to evaluate the effect of a quality management intervention for providers on PAFP uptake. We conducted a pre- and post-intervention study between November 2015 and July 2016 in nine private clinics in Western Kenya. We collected baseline and post-intervention data using in-person interviews on the day of procedure, and follow-up telephone interviews to measure contraceptive uptake in the 2 weeks following abortion. We also conducted semi-structured interviews with providers. The intervention comprised a 1-day orientation, a counselling job-aide, and enhanced supervision visits. The primary outcome was the proportion of clients receiving any method of PAFP (excluding condoms) within 14 days of obtaining an abortion. Secondary outcomes were the proportion of clients receiving PAFP counselling, and the proportion of clients receiving long-acting reversible contraception (LARC) within 14 days of the service. We used chi-squared tests and multivariate logistic regression to determine whether there were significant differences between baseline and post-intervention, adjusting for potential confounding factors and clustering at the clinic level. Interviews were completed with 769 women, and 54% (414 women) completed a follow-up telephone interview. Reported quality of counselling and satisfaction with services increased between baseline and post-intervention. Same-day uptake of PAFP was higher at post-intervention compared to baseline (aOR 1.94, p quality of their services. A quality management intervention was successful in improving the quality of PAFP counselling and provision. Uptake of same-day PAFP, including LARC, increased, but there was no increase in overall uptake of PAFP 2 weeks after the abortion.

  8. Treatment with macrolides and glucocorticosteroids in severe community-acquired pneumonia: A post-hoc exploratory analysis of a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Adrian Ceccato

    Full Text Available Systemic corticosteroids have anti-inflammatory effects, whereas macrolides also have immunomodulatory activity in addition to their primary antimicrobial actions. We aimed to evaluate the potential interaction effect between corticosteroids and macrolides on the systemic inflammatory response in patients with severe community-acquired pneumonia to determine if combining these two immunomodulating agents was harmful, or possibly beneficial.We performed a post-hoc exploratory analysis of a randomized clinical trial conducted in three tertiary hospitals in Spain. This trial included patients with severe community-acquired pneumonia with high inflammatory response (C-reactive protein [CRP] >15 mg/dL who were randomized to receive methylprednisolone 0.5 mg/kg/tpd or placebo. The choice of antibiotic treatment was at the physician's discretion. One hundred and six patients were classified into four groups according to antimicrobial therapy combination (β-lactam plus macrolide or β-lactam plus fluoroquinolone and corticosteroid arm (placebo or corticosteroids. The primary outcome was treatment failure (composite outcome of early treatment failure, or of late treatment failure, or of both early and late treatment failure.The methylprednisolone with β-lactam plus macrolide group had more elderly patients, with comorbidities, and higher pneumonia severity index (PSI risk class V, but a lower proportion of intensive care unit admission, compared to the other groups. We found non differences in treatment failure between groups (overall p = 0.374; however, a significant difference in late treatment failure was observed (4 patients in the placebo with β-lactam plus macrolide group (31% vs. 9 patients in the placebo with β-lactam plus fluoroquinolone group (24% vs. 0 patients in the methylprednisolone with β-lactam plus macrolide group (0% vs. 2 patients [5%] in the methylprednisolone with β-lactam plus fluoroquinolone group overall p = 0.009. We found

  9. Gabapentin for post-operative pain management - a systematic review with meta-analyses and trial sequential analyses

    DEFF Research Database (Denmark)

    Fabritius, M L; Geisler, A; Petersen, P L

    2016-01-01

    ). The primary outcomes were 24-h opioid consumption and incidence of serious adverse events (SAE). RESULTS: One hundred and thirty-two trials with 9498 patients were included. Thirteen trials with low risk of bias reported a reduction in 24-h opioid consumption of 3.1 mg [0.5, 5.6; TSA-adjusted CI: -0.2, 6...

  10. Evaluating the normal individual cardiac function in different imaging phases post exercise and rest by gated SPECT myocardial perfusion

    International Nuclear Information System (INIS)

    Hua, W.; Li, S.J.; Liu, J.Z.; Li, X.F.; Jin, C.R.; Hu, G.; Wang, J.

    2007-01-01

    Full text: Objectives: To evaluate the normal individual cardiac function in the different imaging phases post-exercise and rest by GSPECT. Methods: 46 normal individuals underwent exercise/rest GSPECT using 99mTc-MIBI by 2- day program. Sequential imaging was started 15, 35 and 120 minutes after exercise and rest imaging was performed the following day. The left ventricular EF and EDV, ESV values were calculated with the Cedars-Sinai program. Results: The EF values of post- exercise at 15, 35, and 120m was 64.48±7.43%, 65.02±7.66%, and 60.98±7.28% respectively, and the rest EF value was 61.46±7.23%. The post exercise EF at 15m and 35m was higher than EF at post- exercise 120m and rest, but there is a significant difference only between post exercise 35m and rest (P< 0.05), and all post exercise EF did not increase at least 5% from EF at-rest. The EDV and ESV values did not have statistically significant differences at 15, 35,120m post-exercise and rest. The heart rate at 15,35m post- exercise was higher significantly than at rest. Conclusions: The different imaging phases after exercise with 99mTc-MIBI GSPECT affects LVEF in normal individuals, the 35m post- exercise EF is highest. (author)

  11. Evaluation of post-ESWL renal sequelae using quantitative radionuclide studies

    Energy Technology Data Exchange (ETDEWEB)

    Moustafa, H; Elhaddad, SH; Ziada, G; El-Tawil, A [Nuclear medicine (Egypt); Hegazi, A; Fawzy, K [Urology departments Faculty of medicine, Cairo university, Cairo, (Egypt)

    1995-10-01

    45 adult patients with single, unilateral renal stones without back pressure change attended to Cairo University Hospital during 1990 and 1991 were treated with ESWl. All cases were subjected to radionuclide renal studies using 131 I-OIH and 99 mTc-DTPA done pre-, immediate post- and 3 months post-ESWL. No significant changes of total renal ERPF and GFR could be detected. Treated kidneys GFR, GFR%, ERPE and T max showed no significant changes after ESWL except for a transient significant improvement of their T 1/2 (P<0.04); that occurred immediately after ESWL. Contralateral kidneys showed only transient statistically significant improvement of both %GFR and T 1/2 (P<0.02 and <0.04 respectively) Regional evaluation of the stone bearing zones revealed transient significant deterioration of their regional ERPF (P<0.03). We found that shocks <3500 caused transient significant improvement of treated side ERPF, whereas >3500 shocks caused the reverse (P<0.05). Moreover, power index (number of shocks X KV) >55000 caused deterioration of their GFR that persisted up to 3 months (P<0.03). Conclusion: ESWL therapy is safe method for treatment of renal stones with no significant functional changes. 6 tabs.

  12. Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

    Directory of Open Access Journals (Sweden)

    Anita Panda

    2011-01-01

    Full Text Available Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV in post-penetrating-keratoplasty glaucoma (PKPG. Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7 implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5 < IOP < 21 mmHg and qualified success as 5 < IOP < 21 mmHg with medications or minor procedures. Results: The mean IOP decreased from 42.95 ± 10.24 to 17.69 ± 3.64 mmHg (P < 0.001 and the use of medications dropped from 2.92 to 0.39 (P < 0.001 after AGV implantation. The absolute success was achieved in 11 eyes and qualified success in 9. There was no significant change in best corrected visual acuity, graft clarity, or graft thickness. Six device-related complications occurred after AGV implantations which were successfully managed with medical or minor surgical therapy. Conclusions: Postkeratoplasty refractory glaucoma managed by AGV implantation revealed a satisfactory outcome up to 6 months of follow-up.

  13. Design and evaluation of NEUROBike: a neurorehabilitative platform for bedridden post-stroke patients.

    Science.gov (United States)

    Monaco, Vito; Galardi, Giuseppe; Coscia, Martina; Martelli, Dario; Micera, Silvestro

    2012-11-01

    Over the past decades, a large number of robotic platforms have been developed which provide rehabilitative treatments aimed at recovering walking abilities in post-stroke patients. Unfortunately, they do not significantly influence patients' performance after three months from the accident. One of the main reasons underlying this result seems to be related to the time of intervention. Specifically, although experimental evidences suggest that early (i.e., first days after the injury) and intense neuro-rehabilitative treatments can significantly favor the functional recovery of post-stroke patients, robots require patients to be verticalized. Consequently, this does not allow them to be treated immediately after the trauma. This paper introduces a new robotic platform, named NEUROBike, designed to provide neuro-rehabilitative treatments to bedridden patients. It was designed to provide an early and well-addressed rehabilitation therapy, in terms of kinesiology, efforts, and fatigue, accounting for exercises functionally related to daily motor tasks. For this purpose, kinematic models of leg-joint angular excursions during both walking and sit-to-stand were developed and implemented in control algorithms leading both passive and active exercises. Finally, a set of pilot tests was carried out to evaluate the performance of the robotic platform on healthy subjects.

  14. Randomized Controlled Evaluation of an Early Intervention to Prevent Post-Rape Psychopathology

    Science.gov (United States)

    Resnick, Heidi; Acierno, Ron; Waldrop, Angela E.; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J.; Kilpatrick, Dean

    2007-01-01

    A randomized between-group design was used to evaluate efficacy of a video intervention to reduce PTSD and other mental health problems, implemented prior to the forensic medical exam conducted within 72 hours post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) ages 15 or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with prior rape history relative to scores among women with prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior history who were in the video relative to standard care condition. Small effects indicating higher PTSD and BAI scores among women without a prior history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a video x prior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms. PMID:17585872

  15. A comparative evaluation of semen parameters in pre- and post-Hurricane Katrina human population

    Directory of Open Access Journals (Sweden)

    Caner Baran

    2015-01-01

    Full Text Available A natural disaster leading to accumulation of environmental contaminants may have substantial effects on the male reproductive system. Our aim was to compare and assess semen parameters in a normospermic population residing in the Southern Louisiana, USA area pre- and post-Hurricane Katrina. We retrospectively evaluated semen analyses data (n = 3452 of 1855 patients who attended the Tulane University Andrology/Fertility Clinic between 1999 and 2013. The study inclusion criteria were men whose semen analyses showed ≥ 1.5 ml volume; ≥15 million ml -1 sperm concentration; ≥39 million total sperm count; ≥40% motility; >30% morphology, with an abstinence interval of 2-7 days. After the inclusion criteria applied to the population, 367 normospermic patients were included in the study. Descriptive statistics and group-based analyses were performed to interpret the differences between the pre-Katrina (Group 1, 1999-2005 and the post-Katrina (Group 2, 2006-2013 populations. There were significant differences in motility, morphology, number of white blood cell, immature germ cell count, pH and presence of sperm agglutination, but surprisingly there were no significant differences in sperm count between the two populations. This long-term comparative analysis further documents that a major natural disaster with its accompanied environmental issues can influence certain semen parameters (e.g., motility and morphology and, by extension, fertility potential of the population of such areas.

  16. Evaluation of pre and post-emergence herbicides for weed management in lentil (lens culinaris medik.)

    International Nuclear Information System (INIS)

    Ali, A.; Malik, S.R.; Munawwar, H.; Tahir, M.

    2014-01-01

    The weeds in lentil are one of the major constraints in obtaining maximum yield. The manual weed control is simply not feasible because it is time consuming and costly. The chemical weed control is the effective method of weed management.A field study was conducted to evaluate pre and post-emergence herbicides for weed control in lentil. The experiment comprised eight treatments including three herbicides, manual weeding and check (no weeding). The yield was higher in manual weeding but in herbicide treatments Isoproturon as pre-emergence at the rate 2kg/sup -1/ha produced statistically at par grain yield to that of manual weeding followed by Isoproturon after one month of planting at the rate 2kg ha. Both the treatments showed 193.9% and 109.2% yield increase, respectively, over the check. It indicates that Isoproturon at the rate 2 kg ha can be used pre or post-emergence in lentil fields to control the weeds without causing injury to lentil plants. (author)

  17. Post-stroke Rehabilitation Training with a Motor-Imagery-Based Brain-Computer Interface (BCI)-Controlled Hand Exoskeleton: A Randomized Controlled Multicenter Trial.

    Science.gov (United States)

    Frolov, Alexander A; Mokienko, Olesya; Lyukmanov, Roman; Biryukova, Elena; Kotov, Sergey; Turbina, Lydia; Nadareyshvily, Georgy; Bushkova, Yulia

    2017-01-01

    Repeated use of brain-computer interfaces (BCIs) providing contingent sensory feedback of brain activity was recently proposed as a rehabilitation approach to restore motor function after stroke or spinal cord lesions. However, there are only a few clinical studies that investigate feasibility and effectiveness of such an approach. Here we report on a placebo-controlled, multicenter clinical trial that investigated whether stroke survivors with severe upper limb (UL) paralysis benefit from 10 BCI training sessions each lasting up to 40 min. A total of 74 patients participated: median time since stroke is 8 months, 25 and 75% quartiles [3.0; 13.0]; median severity of UL paralysis is 4.5 points [0.0; 30.0] as measured by the Action Research Arm Test, ARAT, and 19.5 points [11.0; 40.0] as measured by the Fugl-Meyer Motor Assessment, FMMA. Patients in the BCI group ( n = 55) performed motor imagery of opening their affected hand. Motor imagery-related brain electroencephalographic activity was translated into contingent hand exoskeleton-driven opening movements of the affected hand. In a control group ( n = 19), hand exoskeleton-driven opening movements of the affected hand were independent of brain electroencephalographic activity. Evaluation of the UL clinical assessments indicated that both groups improved, but only the BCI group showed an improvement in the ARAT's grasp score from 0 [0.0; 14.0] to 3.0 [0.0; 15.0] points ( p exoskeleton-assisted physical therapy can improve post-stroke rehabilitation outcomes. Both maximum and mean values of the percentage of successfully decoded imagery-related EEG activity, were higher than chance level. A correlation between the classification accuracy and the improvement in the upper extremity function was found. An improvement of motor function was found for patients with different duration, severity and location of the stroke.

  18. Body mass index does not influence post-treatment survival in early stage endometrial cancer: results from the MRC ASTEC trial.

    Science.gov (United States)

    Crosbie, Emma J; Roberts, Chris; Qian, Wendi; Swart, Ann Marie; Kitchener, Henry C; Renehan, Andrew G

    2012-04-01

    Body mass index (BMI) is a major risk factor for endometrial cancer incidence but its impact on post-treatment survival is unclear. We investigated the relationships of BMI (categorised using the WHO definitions) with clinico-pathological characteristics and outcome in women treated within the MRC ASTEC randomised trial, which provides data from patients who received standardised allocated treatments and therefore reduces biases. The impact of BMI on both recurrence-free survival (RFS) and overall survival (OS) was analysed using the Cox regression models. An apriori framework of evaluating potential biases was explored. From 1408 participants, there were 1070 women with determinable BMI (median=29.1 kg/m(2)). Histological types were endometrioid (type 1) in 893 and non-endometrioid (type 2) in 146 women; the proportion of the latter decreasing with increasing BMI (8% versus 19% for obese III WHO category versus normal weight, p(trend)=0.003). For type 1 carcinomas, increasing BMI was associated with less aggressive histopathological features (depth of invasion, p=0.006; tumour grade, p=0.015). With a median follow-up of 34.3 months, there was no influence of BMI on RFS - adjusted HRs per 5 kg/m(2) were 0.98 (95% CI 0.86, 1.13) and 0.95 (0.74, 1.24), for type 1 and 2 carcinomas; and no influence on OS - adjusted HRs per 5 kg/m(2) were 0.96 (0.81, 1.14) and 0.92 (0.70, 1.23), respectively. These findings demonstrate an important principle: that an established link between an exposure (here, obesity) and increased incident cancer risk, does not necessarily translate into an inferior outcome following treatment for that cancer. Copyright © 2011 Elsevier Ltd. All rights reserved.

  19. The longitudinal interplay between negative and positive symptom trajectories in patients under antipsychotic treatment: a post hoc analysis of data from a randomized, 1-year pragmatic trial.

    Science.gov (United States)

    Chen, Lei; Johnston, Joseph A; Kinon, Bruce J; Stauffer, Virginia; Succop, Paul; Marques, Tiago R; Ascher-Svanum, Haya

    2013-11-28

    Schizophrenia is a highly heterogeneous disorder with positive and negative symptoms being characteristic manifestations of the disease. While these two symptom domains are usually construed as distinct and orthogonal, little is known about the longitudinal pattern of negative symptoms and their linkage with the positive symptoms. This study assessed the temporal interplay between these two symptom domains and evaluated whether the improvements in these symptoms were inversely correlated or independent with each other. This post hoc analysis used data from a multicenter, randomized, open-label, 1-year pragmatic trial of patients with schizophrenia spectrum disorder who were treated with first- and second-generation antipsychotics in the usual clinical settings. Data from all treatment groups were pooled resulting in 399 patients with complete data on both the negative and positive subscale scores from the Positive and Negative Syndrome Scale (PANSS). Individual-based growth mixture modeling combined with interplay matrix was used to identify the latent trajectory patterns in terms of both the negative and positive symptoms. Pearson correlation coefficients were calculated to examine the relationship between the changes of these two symptom domains within each combined trajectory pattern. We identified four distinct negative symptom trajectories and three positive symptom trajectories. The trajectory matrix formed 11 combined trajectory patterns, which evidenced that negative and positive symptom trajectories moved generally in parallel. Correlation coefficients for changes in negative and positive symptom subscale scores were positive and statistically significant (P negative and positive symptoms (n = 70, 18%), (2) mild and sustained improvement in negative and positive symptoms (n = 237, 59%), and (3) no improvement in either negative or positive symptoms (n = 82, 21%). This study of symptom trajectories over 1 year shows that changes in negative

  20. Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial

    Science.gov (United States)

    Escontrela Rodriguez, Blanca; Planas Roca, Antonio; Martínez Ruiz, Alberto

    2016-01-01

    Background Non-steroidal anti-inflammatory drugs are often used as components of multimodal therapy for postoperative pain management, but their use is currently limited by its side effects. The specific objective of this study was to evaluate the efficacy and safety of a new formulation of intravenous (IV) ibuprofen for the management of postoperative pain in a European population. Methods and Findings A total of 206 patients from both abdominal and orthopedic surgery, were randomly assigned in 1:1 ratio to receive 800 mg IV-ibuprofen or placebo every 6 hours; all patients had morphine access through a patient controlled analgesia pump. The primary outcome measure was median morphine consumption within the first 24 hours following surgery. The mean±SEM of morphine requirements was reduced from 29,8±5,25 mg to 14,22±3,23 mg (p = 0,015) and resulted in a decrease in pain at rest (p = 0,02) measured by Visual Analog Scale (VAS) from mean±SEM 3.34±0,35 to 0.86±0.24, and also in pain during movement (p = 0,02) from 4.32±0,36 to 1.90±0,30 in the ibuprofen treatment arm; while in the placebo group VAS score at rest ranged from 4.68±0,40 to 2.12±0,42 and during movement from 5.66±0,42 to 3.38±0,44. Similar treatment-emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events. Conclusions Perioperative administration of IV-Ibuprofen 800 mg every 6 hours in abdominal surgery patient’s decreases morphine requirements and pain score. Furthermore IV-Ibuprofen was safe and well tolerate. Consequently we consider appropriate that protocols for management of postoperative pain include IV-Ibuprofen 800 mg every 6 hours as an option to offer patients an analgesic benefit while reducing the potentially risks associated with morphine consumption. Trial Registration EU Clinical Trials Register 2011-005007-33 PMID:27152748

  1. Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial.

    Science.gov (United States)

    Johannsen, Maja; O'Connor, Maja; O'Toole, Mia Skytte; Jensen, Anders Bonde; Højris, Inger; Zachariae, Robert

    2016-10-01

    To assess the efficacy of mindfulness-based cognitive therapy (MBCT) for late post-treatment pain in women treated for primary breast cancer. A randomized wait list-controlled trial was conducted with 129 women treated for breast cancer reporting post-treatment pain (score ≥ 3 on pain intensity or pain burden assessed with 10-point numeric rating scales). Participants were randomly assigned to a manualized 8-week MBCT program or a wait-list control group. Pain was the primary outcome and was assessed with the Short Form McGill Pain Questionnaire 2 (SF-MPQ-2), the Present Pain Intensity subscale (the McGill Pain Questionnaire), and perceived pain intensity and pain burden (numeric rating scales). Secondary outcomes were quality of life (World Health Organization-5 Well-Being Index), psychological distress (the Hospital Depression and Anxiety Scale), and self-reported use of pain medication. All outcome measures were assessed at baseline, postintervention, and 3-month and 6-month follow-up. Treatment effects were evaluated with mixed linear models. Statistically significant time × group interactions were found for pain intensity (d = 0.61; P = .002), the Present Pain Intensity subscale (d = 0.26; P = .026), the SF-MPQ-2 neuropathic pain subscale (d = 0.24; P = .036), and SF-MPQ-2 total scores (d = 0.23; P = .036). Only pain intensity remained statistically significant after correction for multiple comparisons. Statistically significant effects were also observed for quality of life (d = 0.42; P = .028) and nonprescription pain medication use (d = 0.40; P = .038). None of the remaining outcomes reached statistical significance. MBCT showed a statistically significant, robust, and durable effect on pain intensity, indicating that MBCT may be an efficacious pain rehabilitation strategy for women treated for breast cancer. In addition, the effect on neuropathic pain, a pain type reported by women treated for breast cancer, further suggests the potential of MBCT but

  2. A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

    Science.gov (United States)

    Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Lee, Andrew J.; Xiao, Ying

    2013-07-01

    The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10-20 min to 2 min by applying the semi-automated plan-quality evaluation program.

  3. A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

    International Nuclear Information System (INIS)

    Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Xiao, Ying; Lee, Andrew J

    2013-01-01

    The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10–20 min to 2 min by applying the semi-automated plan-quality evaluation program. (note)

  4. Evaluating the effectiveness of a post-license education program for young novice drivers in Belgium.

    Science.gov (United States)

    Brijs, Kris; Cuenen, Ariane; Brijs, Tom; Ruiter, Robert A C; Wets, Geert

    2014-05-01

    The disproportionately large number of traffic accidents of young novice drivers highlights the need for an effective driver education program. The Goals for Driving Education (GDE) matrix shows that driver education must target both lower and higher levels of driver competences. Research has indicated that current education programs do not emphasize enough the higher levels, for example awareness and insight. This has raised the importance of insight programs. On the Road (OtR), a Flemish post-license driver education program, is such an insight program that aims to target these higher levels. The program focus is on risky driving behavior like speeding and drink driving. In addition, the program addresses risk detection and risk-related knowledge. The goal of the study was to do an effect evaluation of this insight program at immediate post-test and 2 months follow-up. In addition, the study aimed to generalize the results of this program to comparable programs in order to make usable policy recommendations. A questionnaire based on the Theory of Planned Behavior (TPB) was used in order to measure participants' safety consciousness of speeding and drink driving. Moreover, we focused on risk detection and risk-related knowledge. Participants (N=366) were randomly assigned to a baseline-follow-up group or a post-test-follow-up group. Regarding speeding and driving, we found OtR to have little effect on the TPB variables. Regarding risk detection, we found no significant effect, even though participants clearly needed substantial improvement when stepping into the program. Regarding risk-related knowledge, the program did result in a significant improvement at post-test and follow-up. It is concluded that the current program format is a good starting point, but that it requires further attention to enhance high level driving skills. Program developers are encouraged to work in a more evidence-based manner when they select target variables and methods to influence

  5. Trial evaluations in comparison with the 1983 safety goals

    International Nuclear Information System (INIS)

    Riggs, R.; Sege, G.

    1985-06-01

    This report provides retrospective comparisons of selected generic regulatory actions to the 1983 NRC safety goals, which had been issued for evaluation during a two-year period. The issues covered are those analyzed by the Office of Nuclear Reactor Regulation (NRR) (assisted in some cases by the Battelle Pacific Northwest Laboratory). The issues include auxiliary feedwater reliability, pressurized thermal shock, power-operated relief valve isolation, asymmetric blowdown loads on PWR primary systems, pool dynamic loads for BWR containments, and steam generator tube rupture. Calculated core-melt frequencies, mortality risks, and cost-benefit ratios are compared with the corresponding safety-goal quantitative design objectives. Considerations that should influence interpretation of the comparisons are discussed. Comments are included on whether and how the safety goals may have helped in the regulatory decision process and on problems encountered

  6. Comparison of nuisance parameters in pediatric versus adult randomized trials: a meta-epidemiologic empirical evaluation

    NARCIS (Netherlands)

    Vandermeer, Ben; van der Tweel, Ingeborg; Jansen-van der Weide, Marijke C.; Weinreich, Stephanie S.; Contopoulos-Ioannidis, Despina G.; Bassler, Dirk; Fernandes, Ricardo M.; Askie, Lisa; Saloojee, Haroon; Baiardi, Paola; Ellenberg, Susan S.; van der Lee, Johanna H.

    2018-01-01

    Background: We wished to compare the nuisance parameters of pediatric vs. adult randomized-trials (RCTs) and determine if the latter can be used in sample size computations of the former. Methods: In this meta-epidemiologic empirical evaluation we examined meta-analyses from the Cochrane Database of

  7. An open-label Optional Titration Trial to Evaluate the Efficacy ...

    African Journals Online (AJOL)

    An eight-week open-label optional titration trial to evaluate the efficacy, tolerability and safety of Valsartan 80 mg/ & 160 mg once daily was carried out in patients with mild to moderate essential hypertension at the Lagos University Teaching Hospital. There was a significant reduction in both systolic and diastolic blood ...

  8. The Results of a Randomized Control Trial Evaluation of the SPARK Literacy Program

    Science.gov (United States)

    Jones, Curtis J.; Christian, Michael; Rice, Andrew

    2016-01-01

    The purpose of this report is to present the results of a two-year randomized control trial evaluation of the SPARK literacy program. SPARK is an early grade literacy program developed by Boys & Girls Clubs of Greater Milwaukee. In 2010, SPARK was awarded an Investing in Innovation (i3) Department of Education grant to further develop the…

  9. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  10. Evaluation of the trial design studies for an advanced marine reactor, (2)

    International Nuclear Information System (INIS)

    Ambo, Noriaki; Yokomura, Takeyoshi.

    1988-03-01

    As for the CARAMEL fuel (plate-type fuel) that was the fuel of the integrated-type reactor which was one of the trial design studies for an Advanced Marine Reactor, its structure and its fuel specific characteristics were studied and compared with a fuel rod (cylindrical fuel), and the total characteristics of the caramel fuel was reviewed and evaluated. (author)

  11. Evaluation of ammonium bifluoride fusion for rapid dissolution in post-detonation nuclear forensic analysis

    International Nuclear Information System (INIS)

    Hubley, Nicholas T.; Brockman, John D.; Robertson, J. David; Missouri Univ., Columbia, MO

    2017-01-01

    Dissolution of geological reference materials by fusion with ammonium bifluoride, NH_4HF_2 or ABF, was evaluated for its potential use in post-detonation nuclear forensics. The fusion procedure was optimized such that the total dissolution time was <3 h without compromising recovery. Geological reference materials containing various levels of silicates were dissolved and measured by ICP-MS to quantify elemental recovery. Dissolutions of NIST 278 obsidian and urban canyon matrix were performed with radiotracer spikes to measure potential loss of volatile elements during the fusion procedure via gamma-ray spectroscopy. Elemental percent recoveries obtained by ICP-MS were found to be 80-120% while recoveries of radiotracers were observed to be 90-100% with the exception of iodine.

  12. Evaluation of ammonium bifluoride fusion for rapid dissolution in post-detonation nuclear forensic analysis

    Energy Technology Data Exchange (ETDEWEB)

    Hubley, Nicholas T. [Missouri Univ., Columbia, MO (United States). Dept. of Chemistry; Brockman, John D. [Missouri Univ., Columbia, MO (United States). Research Reactor Center; Robertson, J. David [Missouri Univ., Columbia, MO (United States). Research Reactor Center; Missouri Univ., Columbia, MO (United States). Dept. of Chemistry

    2017-10-01

    Dissolution of geological reference materials by fusion with ammonium bifluoride, NH{sub 4}HF{sub 2} or ABF, was evaluated for its potential use in post-detonation nuclear forensics. The fusion procedure was optimized such that the total dissolution time was <3 h without compromising recovery. Geological reference materials containing various levels of silicates were dissolved and measured by ICP-MS to quantify elemental recovery. Dissolutions of NIST 278 obsidian and urban canyon matrix were performed with radiotracer spikes to measure potential loss of volatile elements during the fusion procedure via gamma-ray spectroscopy. Elemental percent recoveries obtained by ICP-MS were found to be 80-120% while recoveries of radiotracers were observed to be 90-100% with the exception of iodine.

  13. Metallurgical evaluation of failed post-tensioned containment tendon anchors at Joseph M. Farley Unit 2

    International Nuclear Information System (INIS)

    Czajkowski, C.J.

    1986-01-01

    A metallurgical examination has been performed on three failed post-tensioned containment tendon anchors and one intact anchor from the Farley Unit 2 Nuclear Power Station. The evaluation consisted of chemical/mechanical testing, optical microscopy, scanning electron microscopy, and energy dispersive spectroscopy. The conclusions drawn from the investigation were: 1) the anchors met the chemical and mechanical properties of AISI 4140/4142 steel; 2) there was no evidence of phosphorous segregation to the grain boundary (by ethereal picral etch); 3) the observed cracking was generally a mixed mode of intergranular and quasi-cleavage as well as ductile rupture with the intergranular cracking occurring along prior austenite grain boundaries; 4) the results of the mechanical tests coupled with the discontinuous nature of the intergranular areas and the elimination of other modes of failure give sufficient indication that the failure was a hydrogen induced cracking phenomenon

  14. Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kate Reiss

    2017-10-01

    Full Text Available Abstract Background Adoption of modern contraceptive methods after menstrual regulation (MR is thought to reduce subsequent unwanted pregnancy and abortion. Long-acting reversible contraceptives (LARCs are highly effective at reducing unintended pregnancy, but uptake in Bangladesh is low. Providing information on the most effective methods of contraception increases uptake of more effective methods. This protocol describes a randomised controlled trial of an intervention delivered by mobile phone designed to support post-MR contraceptive use in Bangladesh. Methods This is a multi-site single blind individual randomised controlled trial. At least 960 women undergoing MR procedures at selected facilities will be recruited after their procedure by female research assistants. Women will be randomised into the control or intervention group with a 1:1 ratio. All participants will receive usual clinic care, including contraceptive counselling and the telephone number of a non-toll-free call centre which provides counselling on MR and contraception. During the 4 months after their MR procedure, intervention participants will be sent 11 recorded interactive voice messages to their mobile phone about contraception with a focus on their chosen method and LARCs. Each message allows the participant to connect directly to the call centre. The intervention is free to the user. The control group will receive no messages delivered by mobile phone. All participants will be asked to complete an in-person questionnaire at recruitment and follow-up questionnaires by telephone at 2 weeks, 4 months and 12 months after their MR. The primary outcome for the trial will be self-reported LARC use 4 months post-MR. Secondary outcomes include LARC use at 2 weeks and 12 months post-MR, use of any effective modern contraceptive method at 2 weeks, 4 months and 12 months post-MR, and contraceptive discontinuation, contraceptive method switching, pregnancy, subsequent MR and

  15. Designing and evaluating the effectiveness of a serious game for safe administration of blood transfusion: A randomized controlled trial.

    Science.gov (United States)

    Tan, Apphia Jia Qi; Lee, Cindy Ching Siang; Lin, Patrick Yongxing; Cooper, Simon; Lau, Lydia Siew Tiang; Chua, Wei Ling; Liaw, Sok Ying

    2017-08-01

    Preparing nursing students for the knowledge and skills required for the administration and monitoring of blood components is crucial for entry into clinical practice. Serious games create opportunities to develop this competency, which can be used as a self-directed learning strategy to complement existing didactic learning and simulation-based strategies. To describe the development and evaluation of a serious game to improve nursing students' knowledge, confidence, and performance in blood transfusion. An experiential gaming model was applied to guide the design of the serious game environment. A clustered, randomized controlled trial was conducted with 103 second-year undergraduate nursing students who were randomized into control or experimental groups. After a baseline evaluation of the participants' knowledge and confidence on blood transfusion procedure, the experimental group undertook a blood transfusion serious game and completed a questionnaire to evaluate their learning experience. All participants' clinical performances were evaluated in a simulated environment. The post-test knowledge and confidence mean scores of the experimental group improved significantly (pgame intervention compared to pre-test mean scores and to post-test mean scores of the control group (pgame positively. The study provided evidence on the effectiveness of a serious game in improving the knowledge and confidence of nursing students on blood transfusion practice. The features of this serious game could be further developed to incorporate additional scenarios with repetitive exercises and feedback to enhance the impact on clinical performance. Given the flexibility, practicality, and scalability of such a game, they can serve as a promising approach to optimize learning when blended with high-fidelity simulation. Copyright © 2017. Published by Elsevier Ltd.

  16. The impacts of household retrofit and domestic energy efficiency schemes: A large scale, ex post evaluation

    International Nuclear Information System (INIS)

    Webber, Phil; Gouldson, Andy; Kerr, Niall

    2015-01-01

    There is widespread interest in the ability of retrofit schemes to shape domestic energy use in order to tackle fuel poverty and reduce carbon emissions. Although much has been written on the topic, there have been few large-scale ex post evaluations of the actual impacts of such schemes. We address this by assessing domestic energy use before and after the Kirklees Warm Zone (KWZ) scheme, which by fitting insulation in 51,000 homes in the 2007–2010 period is one of the largest retrofit schemes completed in the UK to date. To do this, we develop and apply a new methodology that isolates the impacts of retrofit activity from broader background trends in energy use. The results suggest that the actual impacts of the KWZ scheme have been higher than predicted, and that the scale of any performance gaps or rebound effects have been lower than has often been assumed. They also suggest that impacts on energy use in lower income areas are consistent with predictions, but that impacts in middle and higher income areas are higher than predicted. These findings support the case for the wider and/or accelerated adoption of domestic retrofit schemes in other contexts. -- Highlights: •A large scale, ex post evaluation of the impacts of a household retrofit scheme. •A new methodology to separate retrofit impacts from background trends. •Shows impacts of retrofit have been 1.2–1.7 times higher than predicted. •Impacts as predicted in lower income areas, higher in middle and upper income areas. •Findings support the case for the wider and faster adoption of domestic retrofit

  17. Evaluation of unilateral cleft lip and palate using anthropometry measurements post-alveolar bone grafting

    Science.gov (United States)

    Simorangkir, H. J.; Hak, M. S.; Tofani, I.

    2017-08-01

    Rehabilitation of patients with unilateral cleft lip and palate (UCLP) requires multiple steps and coordination of multidisciplinary sciences to produce optimal results. Alveolar bone-grafting (ABG) is an important procedure in the treatment of such patients because it influences the eruption of teeth and stabilizes the maxilla. To evaluate the effect and suitability of alveolar bone grafting procedure at Cleft Center Harapan Kita Maternal and Child Hospital on nasal deformity from anthropometry with photogrammetry and aesthetic proportional in patients with unilateral cleft lip and palate with UCLP. Patients with UCLP were evaluated post-ABG using anthropometry and photogrammetry to investigate the results anteriorly, laterally, and basally. Anthropometric measurements taken photogrammetrically used 14 points and 11 distance items. Evaluations were made of upper lip length, upper lip projection, and nostril sill elevation for both the cleft and non-cleft sides of patients’ faces. A t-test showed that the values for upper lip length and projection were significantly increased, and a correction test using a Fisher exam gave a value of 1. The ABG treatment protocol for patients with UCLP at the Cleft Lip and Palate Unit at Harapan Kita Maternal and Child Hospital is suitable to be performed; it aesthetically satisfies patients and their families.

  18. Evaluation of quality of the post-mining reclaimed landscape by means of the landscape functions

    Energy Technology Data Exchange (ETDEWEB)

    Bodlak, L.; Krovakova, K. [South Bohemia Univ., Ceske Budejovice (Czech Republic). Faculty of Agriculture; Hesslerova, P.; Pecharova, E. [Czech Univ. of Life Sciences, Prague (Czech Republic). Faculty of Environmental Science

    2010-07-01

    In order to evaluate landscape functions, the mutual correlation between land cover temperature, wetness and water conductivity can be employed. There is lower oscillation of temperatures with higher wetness and lower values of dissolved chemical substances or conductivity in the correctly functioning landscape. This paper presented a new approach to evaluate the quality of post-mining reclaimed landscape combining remote sensing methods and surface water chemistry monitoring. The studied area was the Podkrusnohorska dump in Northern Bohemia. Satellite scenes of the Landsat were used for evaluating land cover temperature and wetness indexes. Conductivity was measured in the surface waters discharged of the dump. The paper presented the methodology, with particular reference to temperature scenes and scenes of wetness indexes; standardization of the scenes; data synthesis; connection of temperature-wetness parameters with the chemical ones; data collection and processing; conductivity raster standardization; and visualization of the final layer. It was concluded that the method presented in this paper allowed the detection of well-functioning and unstable parts of the dump and provided basic information about the effectiveness of the reclamation. 9 refs., 2 figs.

  19. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

  20. [Random clinical comparative trial between free and directed exercise in post-operative complications of breast cancer].

    Science.gov (United States)

    Rezende, Laura Ferreira de; Beletti, Patricia Odila; Franco, Ricardo Laier; Moraes, Sirlei Siani; Gurgel, Maria Salete Costa

    2006-01-01

    The objective of this study was to evaluate the association among physiotherapy exercises performed--directed or free--in case of post-operative complications in women who underwent radical mastectomy or quadrantectomy with axillary dissection. Sixty women were randomized. The directed group performed physiotherapy following a regimen of 19 exercises. The free group performed the exercises following the biomechanical physiological movements of the shoulder without a previously defined sequence or number of repetitions, exercises were done to the rhythm of music. In the average, the directed group remained 12.17 + 2.96 days with the drain, while the free group remained 11.96 + 2.32 days, with no significant difference between groups. The amount of secretion drained during the permanence of the drain also revealed resemblance between groups, with an average of 1308.71 + 562.6 ml in the directed group and of 1391.62 + 644.65 ml in the group of free exercises. Incidences of seroma and dehiscence of the surgical wound did not seem to be influenced by the type of exercise at any of the times evaluated. In the directed group, 7.4% and 3.4% of the women presented with seroma on the 28th and 42nd days, respectively, while at the same moments of evaluation the free group presented respectively. 3.6% and 3.6%. Incidence of dehiscence of the surgical wound also was similar in the two groups, in the directed group it was of 20% on the 14th day, 31% on the 28th day and 10.3% on the 42nd day of postoperative. In the free group the incidence was of 23.3% on the 14th day, of 33.3% on the 28th day and of 22.2% on the 42nd day of postoperative. The statistical difference observed in the averages of the hand and arm circumferences does not translate into clinical differences. The complications were not influenced f by the physiotherapy exercises performed.

  1. Adding a post-training FIFA 11+ exercise program to the pre-training FIFA 11+ injury prevention program reduces injury rates among male amateur soccer players: a cluster-randomised trial

    Directory of Open Access Journals (Sweden)

    Wesam Saleh A Al Attar

    2017-10-01

    Trial registration: ACTRN12615001206516. [Al Attar WSA, Soomro N, Pappas E, Sinclair PJ, Sanders RH (2017 Adding a post-training FIFA 11+ exercise program to the pre-training FIFA 11+ injury prevention program reduces injury rates among male amateur soccer players: a cluster-randomised trial. Journal of Physiotherapy 63: 235–242

  2. FDG PET as a prognostic predictor in the early post-therapeutic evaluation for unresectable hepatocellular carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Higashi, Tatsuya; Nishii, Ryuichi [Shiga Medical Center Research Institute, Moriyama City, Shiga (Japan); Hatano, Etsuro; Ikai, Iwao; Seo, Satoru; Kitamura, Koji; Takada, Yasuji; Kamimoto, Shinji [Kyoto University Graduate School of Medicine, Department of Gastroenterological Surgery, Sakyo-ku, Kyoto (Japan); Nakamoto, Yuji; Ishizu, Koichi; Suga, Tsuyoshi; Kawashima, Hidekazu; Togashi, Kaori [Kyoto University Graduate School of Medicine, Department of Diagnostic Imaging and Nuclear Medicine, Sakyo-ku, Kyoto (Japan)

    2010-03-15

    To elucidate the prognostic role of post-therapeutic {sup 18}F-fluorodeoxyglucose ({sup 18}F-FDG) positron emission tomography (PET), we conducted a retrospective cohort study analysing the clinical factors that affect overall survival after non-operative therapy for unresectable hepatocellular carcinoma (HCC). Sixty-seven cases with unresectable HCC who received non-operative therapy (transcatheter arterial chemoembolization: n=24, transcatheter arterial infusion chemotherapy: n=31, radiofrequency ablation: n = 5 or systemic chemotherapy: n = 7) and had received FDG PET for the evaluation of the therapeutic effect within 1 month after the end of the therapy were evaluated. Overall survival rate was evaluated using the univariate and multivariate analyses of relevant clinical and laboratory parameters before and after therapy, including visual PET analysis and quantitative analysis using maximum standardized uptake value (SUV). Visual PET diagnosis of post-therapeutic lesions was a good predictor of overall survival of unresectable HCC patients. The low FDG group showed significantly longer survival (average: 608 days) than that (average: 328 days) of the high FDG group (p<0.0001). Multivariate analysis showed four significant prognostic factors for the survival: post-therapeutic alpha-fetoprotein ({alpha}FP) level (=400 ng/ml, p=0.004), post-therapeutic visual PET diagnosis (p=0.006), post-therapeutic clinical stage (UICC stage IV, p=0.04) and post-therapeutic Milan criteria (p=0.03), while pre-therapeutic clinical factors, SUV by post-therapeutic FDG PET (5.0 or more) or others did not show significance. The present study suggests that post-therapeutic PET performed within 1 month after non-operative therapy can be a good predictor of overall survival in unresectable HCC patients, while pre-therapeutic evaluation including PET, tumour markers and clinical staging may not be useful. (orig.)

  3. Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca

    2014-10-29

    Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection

  4. Occupational therapy discharge planning for older adults: A protocol for a randomised trial and economic evaluation

    Directory of Open Access Journals (Sweden)

    Wales Kylie

    2012-07-01

    Full Text Available Abstract Background Decreased functional ability is common in older adults after hospitalisation. Lower levels of functional ability increase the risk of hospital readmission and nursing care facility admission. Discharge planning across the hospital and community interface is suggested to increase functional ability and decrease hospital length of stay and hospital readmission. However evidence is limited and the benefits of occupational therapists providing this service has not been investigated. This randomised trial will investigate the clinical effectiveness of a discharge planning program in reducing functional difficulties of older adults post-discharge. This trial will also examine the cost of the intervention and cost effectiveness when compared to in-hospital discharge planning. Methods/design 400 participants admitted to participating hospitals will be recruited. Participants will be 70 years of age and over, have no significant cognitive impairment and be independently mobile at discharge. This study protocol was approved by the ethics committee of Ryde Rehabilitation Human Research Ethics Committee, Western Sydney Local Health District (Westmead Campus Human Research Ethics Committee, Alfred Health Human Research ethics committee for the randomised trial and NSW Population and Health Service Human Research Ethics Committee for data linkage. Participants will provide informed written consent. Participants will be randomly allocated to the intervention or control group. The intervention group will receive discharge planning therapies primarily within their home environment while the control group will receive an in-hospital consultation, both provided by trained occupational therapists. Primary outcome measures will be the Nottingham Extended Activities of Daily Living Scale (NEADL and the Late Life Disability Index (LLDI which will measure functional independence, and participation and limitation in daily life activities

  5. The Correction of Myopia Evaluation Trial: lessons from the study design.

    Science.gov (United States)

    Hyman, L; Gwiazda, J

    2004-01-01

    The Correction of Myopia Evaluation Trial (COMET), a multicentre clinical trial based in 4 schools of optometry in the United States, evaluated the effect of progressive addition lenses versus single vision lenses on myopia progression in an ethnically diverse group of 469 myopic children aged 6 to 11 years. Completion of the clinical trial phase of the study provides an opportunity to evaluate aspects of the study design that contribute to its success. This article describes aspects of the study design that were influential in ensuring the smooth conduct of COMET. These include a dedicated team of investigators, an organisational structure with strong leadership and an independent Co-ordinating Centre, regular communication among investigators, flexible and creative approaches to recruitment and retention, sensitivity to concerns for child safety and child participation, and methods for enhancing and monitoring data reliability. The experience with COMET has provided a number of valuable lessons for all aspects of the study design that should benefit the development and implementation of future clinical trials, particularly those done in similar populations of children. The use of a carefully designed protocol using standard methods by dedicated members of the study team is essential in ensuring achievement of the study aims.

  6. Evaluation of a Decision Aid for Women with Epilepsy Who Are Considering Pregnancy: A Randomized Controlled Trial.

    Science.gov (United States)

    McGrath, Amanda; Sharpe, Louise; Lah, Suncica; Parratt, Kaitlyn

    2017-07-01

    For many women with epilepsy (WWE), decision making about pregnancy is complicated by considerations such as the potential teratogenicity of antiepileptic drugs, offspring risk of epilepsy, seizure occurrence during pregnancy, and the challenges of parenting amidst poorly controlled seizures. This proof-of-concept, randomized controlled trial aimed to evaluate a decision aid (DA) developed to help WWE decide if they should start or enlarge their families. Seventy-nine WWE of childbearing age were recruited from Epilepsy Action Australia between October and November 2013 and randomized to receive the intervention (the DA) or not, and to complete a set of questionnaires pre- and post- intervention. The DA, delivered as a PDF booklet, provided balanced evidence-based information about options, risks and benefits, including probabilities; as well as steps for clarifying values and considering options within one's personal situation. Compared with the control group, the DA group had statistically significant improvements in knowledge about pregnancy and epilepsy (Cohen's d = 1.24; 95%CI = 0.77 to 1.83) and reduced decisional conflict (Cohen's d = 0.59; 95%CI = 0.21 to 0.99). Changes in decision self-efficacy, certainty of choice, patient-practitioner communication abilities and value congruence with choice were comparable between the DA and control group. Importantly, women's decisions about motherhood were not biased towards either direction, and there were no adverse effects on depression or anxiety. All women who received the DA indicated they would recommend it to other WWE. The DA has the potential to serve as a useful support tool for WWE who are considering motherhood. Future research is needed to test the DA in clinical settings with guidance from a health professional. The trial was registered with the Australian New Zealand Clinical Trials Registry (ID ACTRN12613001082796).

  7. Feasibility and Efficacy of an mHealth Game for Managing Anxiety: "Flowy" Randomized Controlled Pilot Trial and Design Evaluation.

    Science.gov (United States)

    Pham, Quynh; Khatib, Yasmin; Stansfeld, Stephen; Fox, Simon; Green, Tobias

    2016-02-01

    Meeting the complex needs of patients with chronic common mental health disorders (CMHDs) may be the greatest challenge facing organized medical practice. On the basis of a well-established and proven theoretical foundation for controlled respiration as a behavioral intervention for CMHDs, as well as preliminary evidence that gamification can improve health outcomes through increasing patient engagement, this randomized controlled pilot study evaluated the feasibility and clinical efficacy of a mobile health game called "Flowy" ( www.flowygame.com ) that digitally delivered breathing retraining exercises for anxiety, panic, and hyperventilation symptom management. We designed an unblinded, Web-based, parallel-group randomized controlled trial focusing on feasibility, clinical efficacy, and design proof of concept. In the intervention condition (n = 31), participants received free access to "Flowy" for 4 weeks. In the control condition (n = 32), participants were placed on a waitlist for 4 weeks before being offered free access to "Flowy." Online measurements using psychological self-report questionnaires were made at 2 and 4 weeks post-baseline. At trial conclusion, participants found "Flowy" acceptable as an anxiety management intervention. "Flowy" engaged participants sufficiently to endorse proactive gameplay. Intent-to-treat analysis revealed a reduction in anxiety, panic, and self-report hyperventilation scores in both trial arms, with the intervention arm experiencing greater quality of life. Participants perceived "Flowy" as a fun and useful intervention, proactively used "Flowy" as part of their care, and would recommend "Flowy" to family and friends. Our results suggest that a digital delivery of breathing retraining exercises through a mobile health game can manage anxiety, panic, and hyperventilation symptoms associated with CMHDs.

  8. Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dennis Martin

    2012-03-01

    Full Text Available Abstract Background Approximately 80,000 patients each year are admitted to UK hospitals with an acute stroke and are immobile. At least 10% will develop a proximal Deep Vein Thrombosis in the first month and 1.5% a pulmonary embolus. Although hydration, antiplatelet treatment and early mobilisation may reduce the risk of deep vein thrombosis, there are currently no preventive strategies which have been clearly shown to be both effective and safe. Anticoagulation increases the risks of bleeding and compression stockings are ineffective. Systematic reviews of small randomized trials of intermittent pneumatic compression have shown that this reduces the risk of deep vein thrombosis in patients undergoing surgery, but that there are few data concerning its use after stroke. The CLOTS trial 3 aims to determine whether, compared with best medical care, best medical care plus intermittent pneumatic compression in immobile stroke patients reduces the risk of proximal deep vein thrombosis. Methods/Design CLOTS Trial 3 is a parallel group multicentre trial; with centralized randomisation (minimisation to ensure allocation concealment. Over 80 centres in the UK will recruit 2800 immobile stroke patients within the first 3 days of their hospital admission. Patients will be allocated to best medical care or best medical care plus intermittent pneumatic compression. Ultrasonographers will perform a Compression Duplex Ultrasound Scan to detect deep vein thrombosis in each treatment group at about 7-10 days and 25-30 days. The primary outcome cluster includes symptomatic or asymptomatic deep vein thrombosis in the popliteal or femoral veins detected on either scan. Patients are then followed up by postal or telephone questionnaire at 6 months from randomisation to detect later symptomatic deep vein thrombosis and pulmonary emboli and to establish their functional outcome (Oxford handicap scale and quality of life (EQ5D-3 L. The ultrasonographers performing the

  9. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    Science.gov (United States)

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

  10. The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Huang, Jia; Lin, Zhengkun; Wang, Qin; Liu, Feiwen; Liu, Jiao; Fang, Yunhua; Chen, Shanjia; Zhou, Xiaoxuan; Hong, Wenjun; Wu, Jinsong; Madrigal-Mora, Natalia; Zheng, Guohua; Yang, Shanli; Tao, Jing; Chen, Lidian

    2015-06-16

    Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI. A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period). This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages. This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.

  11. A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

    Science.gov (United States)

    Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

    2014-09-01

    To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

  12. Evaluation of a post-analysis method for cumulative dose distribution in stereotactic body radiotherapy

    International Nuclear Information System (INIS)

    Imae, Toshikazu; Takenaka, Shigeharu; Saotome, Naoya

    2016-01-01

    The purpose of this study was to evaluate a post-analysis method for cumulative dose distribution in stereotactic body radiotherapy (SBRT) using volumetric modulated arc therapy (VMAT). VMAT is capable of acquiring respiratory signals derived from projection images and machine parameters based on machine logs during VMAT delivery. Dose distributions were reconstructed from the respiratory signals and machine parameters in the condition where respiratory signals were without division, divided into 4 and 10 phases. The dose distribution of each respiratory phase was calculated on the planned four-dimensional CT (4DCT). Summation of the dose distributions was carried out using deformable image registration (DIR), and cumulative dose distributions were compared with those of the corresponding plans. Without division, dose differences between cumulative distribution and plan were not significant. In the condition Where respiratory signals were divided, dose differences were observed over dose in cranial region and under dose in caudal region of planning target volume (PTV). Differences between 4 and 10 phases were not significant. The present method Was feasible for evaluating cumulative dose distribution in VMAT-SBRT using 4DCT and DIR. (author)

  13. Post-Occupancy Evaluation of a Mental Healthcare Facility Based on Staff Perceptions of Design Innovations.

    Science.gov (United States)

    Kalantari, Saleh; Snell, Robin

    2017-07-01

    This study was a post-occupancy evaluation (POE) to examine the effectiveness of three specific design innovations in a mental healthcare facility. In addition to collecting data about the impact of these specific designs, the study provides a model for the broader implementation of POE approaches in the mental healthcare context. POEs in general healthcare settings have been shown to lead to better work environments and better outcomes for patients. Despite growing evidence of the value provided by POE studies, the industry has been somewhat slow to adopt their regular use, in part due to unfamiliarity with the POE process. This is particularly true in mental healthcare contexts, where POE studies remain virtually nonexistent. In-depth interviews and a widely distributed, anonymous survey were used to collect hospital staff perceptions and feedback regarding the impact of specific design features. The hospital staff were quite enthusiastic about two of the design innovations studied here (a new wayfinding strategy and the use of vibrant colors in specific areas of the facility). The third innovation, open-style communication centers, elicited more mixed evaluations. The results include extensive hypothesis testing about the effects of each innovation as well as narrative discussions of their pros and cons. The study generated new knowledge about three specific mental healthcare design innovations and provides a model for the practical implementation of a POE approach in mental healthcare contexts. The results are particularly relevant for designers who are considering innovative strategies in future mental healthcare facilities.

  14. Post-Occupancy Evaluation Data Support for Planning and Management of Building Maintenance Plans

    Directory of Open Access Journals (Sweden)

    Nelson Bento Pereira

    2016-10-01

    Full Text Available The purpose of this paper is to propose a post-occupancy evaluation (POE method focused on building maintenance and then to test it on two different sets of residential buildings. The paper’s three main goals are: to obtain useful data for optimizing the buildings’ maintenance plans; to search for any correlation between the occupants’ characteristics and their expectations toward the building; to study the occupants’ willingness to pay for maintenance procedures, as well as its correlation with the occupants’ perception of the elements source of maintenance (ESM. The proposed POE method for building maintenance performance evaluation (BMPE consists of six main stages, focusing on the occupants’ opinions and their correlation with the facility manager’s. The observed case studies allowed for a preliminary validation of the POE method for BMPE. Results generically endorsed the method as a valuable tool for the rapprochement between facility management and the building’s end-users. Such findings could allow facility managers to develop more efficient maintenance plans focusing on the occupants’ real needs and expectations, raising occupant satisfaction levels and contributing to the building’s general performance.

  15. Clinical information system post-adoption evaluation at the georges pompidou university hospital.

    Science.gov (United States)

    Palm, Jean-Marc; Dart, Thierry; Dupuis, Isabelle; Leneveut, Laurence; Degoulet, Patrice

    2010-11-13

    The evaluation of a clinical information system (CIS) at different stages of deployment and routine use is a key factor to improve acceptability and use by health professionals. This paper examines on an expectation-confirmation model (ITPAM) the relationships between the determinants of success of a CIS in a cross-sectional survey performed at the Georges Pompidou University Hospital (HEGP). Results for the groups of physicians and nurses that replied to the survey (n=312) suggest that health professional satisfaction (overall R(2)=0.60) is determined by the quality of user support (r=.21, p=<0001), ease of use (r=.19, p=<0001), confirmation of expectations (r=.15, p=.0037), usefulness (r=.12, p=.0068), and compatibility (r=.10, p=.0206). The best predictor of physician satisfaction (R(2)=0.71) was compatibility (r=.21, p=.0072) whereas for nurses (R(2)=0.52) it was user support (r=.22, p=<0001) and ease of use (r=.22, p=.0001). Confirmation of expectations had an impact on post-adoption expectation and user's satisfaction, and confirms its importance for CIS evaluation studies.

  16. POST OCCUPANCY EVALUATION OF ENERGY-EFFICIENT BUILDINGS IN TROPICAL CLIMATES – MALAYSIA

    Directory of Open Access Journals (Sweden)

    Ban-Huat Ng

    2013-07-01

    Full Text Available There exists a well-known gap between occupants and building’s energy-efficient designs. A comprehensive building performance diagnostic technique, Post Occupancy Evaluation (POE may surpass the current evaluation method by reducing the gap between occupants and building’s energy-efficient design. Due to these reasons, the aim of this research is to identify the problems with respect to energy-efficient design which affect occupants’ comfort. This research focuses on the application of energy-efficient design in office building and was conducted on energy-efficient buildings in Malaysia. A building performance survey framework, Energy-efficient Building Environmental Quality Questionnaire (EBEQ2, was  used to identify the problems affecting occupants’ comfort and buildings’ Indoor Environmental Quality (IEQ. The result was analyzed using Statistical Package for Social Science (SPSS. The research outcome shows that majority of occupants are not satisfied  with the thermal comfort and lighting condition of  the buildings. Building certified with sustainable building rating tools does not guarantee better IEQ performance. Thus  continuous research is needed to ensure energy-efficient building concept is applied effectively in each type of building.

  17. Evaluation of Pre- and Post- Redevelopment Groundwater Chemical Analyses from LM Monitoring Wells

    International Nuclear Information System (INIS)

    Kamp, Susan; Dayvault, Jalena

    2016-01-01

    This report documents the efforts and analyses conducted for the Applied Studies and Technology (AS&T) Ancillary Work Plan (AWP) project titled Evaluation of Pre- and Post- Redevelopment Groundwater Sample Laboratory Analyses from Selected LM Groundwater Monitoring Wells. This effort entailed compiling an inventory of nearly 500 previous well redevelopment events at 16 U.S. Department of Energy Office of Legacy Management (LM) sites, searching the literature for impacts of well redevelopment on groundwater sample quality, and-the focus of this report-evaluating the impacts of well redevelopment on field measurements and sample analytical results. Study Catalyst Monitoring well redevelopment, the surging or high-volume pumping of a well to loosen and remove accumulated sediment and biological build-up from a well, is considered an element of monitoring well maintenance that is implemented periodically during the lifetime of the well to mitigate its gradual deterioration. Well redevelopment has been conducted fairly routinely at a few LM sites in the western United States (e.g., the Grand Junction office site and the Gunnison processing site in Colorado), but at most other sites in this region it is not a routine practice. Also, until recently (2014-2015), there had been no specific criteria for implementing well redevelopment, and documentation of redevelopment events has been inconsistent. A catalyst for this evaluation was the self-identification of these inconsistencies by the Legacy Management Support contractor. As a result, in early 2015 Environmental Monitoring Operations (EMO) staff began collecting and documenting additional field measurements during well redevelopment events. In late 2015, AS&T staff undertook an independent internal evaluation of EMO's well redevelopment records and corresponding pre- and post-well-redevelopment groundwater analytical results. Study Findings Although literature discussions parallel the prevailing industry

  18. Evaluation of Pre- and Post- Redevelopment Groundwater Chemical Analyses from LM Monitoring Wells

    Energy Technology Data Exchange (ETDEWEB)

    Kamp, Susan [Navarro Reserch and Engineering, Oak Ridge, TN (United States); Dayvault, Jalena [US Department of Energy, Washington, DC (United States). Office of Legacy Management

    2016-05-01

    This report documents the efforts and analyses conducted for the Applied Studies and Technology (AS&T) Ancillary Work Plan (AWP) project titled Evaluation of Pre- and Post- Redevelopment Groundwater Sample Laboratory Analyses from Selected LM Groundwater Monitoring Wells. This effort entailed compiling an inventory of nearly 500 previous well redevelopment events at 16 U.S. Department of Energy Office of Legacy Management (LM) sites, searching the literature for impacts of well redevelopment on groundwater sample quality, and—the focus of this report—evaluating the impacts of well redevelopment on field measurements and sample analytical results. Study Catalyst Monitoring well redevelopment, the surging or high-volume pumping of a well to loosen and remove accumulated sediment and biological build-up from a well, is considered an element of monitoring well maintenance that is implemented periodically during the lifetime of the well to mitigate its gradual deterioration. Well redevelopment has been conducted fairly routinely at a few LM sites in the western United States (e.g., the Grand Junction office site and the Gunnison processing site in Colorado), but at most other sites in this region it is not a routine practice. Also, until recently (2014–2015), there had been no specific criteria for implementing well redevelopment, and documentation of redevelopment events has been inconsistent. A catalyst for this evaluation was the self-identification of these inconsistencies by the Legacy Management Support contractor. As a result, in early 2015 Environmental Monitoring Operations (EMO) staff began collecting and documenting additional field measurements during well redevelopment events. In late 2015, AS&T staff undertook an independent internal evaluation of EMO's well redevelopment records and corresponding pre- and post-well-redevelopment groundwater analytical results. Study Findings Although literature discussions parallel the prevailing industry

  19. Trial-based economic evaluations in occupational health: principles, methods, and recommendations.

    Science.gov (United States)

    van Dongen, Johanna M; van Wier, Marieke F; Tompa, Emile; Bongers, Paulien M; van der Beek, Allard J; van Tulder, Maurits W; Bosmans, Judith E

    2014-06-01

    To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions.

  20. The Sandia/Arzamas-16 Magazine-to-Magazine Remote Monitoring Field Trial Evaluation

    International Nuclear Information System (INIS)

    Barkanov, Boris; Blagin, Sergei; Croessmann, Dennis; Damico, Joe; Ehle, Steve; Nilsen, Curt

    1999-01-01

    Sandia National Laboratories and the Russian Federal Nuclear Center-All Russian Research Institute for Experimental Physics (VNIIEF) (also known as Arzamas-16) are collaborating on ways to assure the highest standards of safety, security, and international accountability of fissile material. For these collaborations, sensors and information technologies have been identified as important in reaching these standards in a cost-effective manner. Specifically, Sandia and VNIIEF have established a series of remote monitoring field trials to provide a mechanism for joint research and development on storage monitoring systems. These efforts consist of the ''Container-to-Container'', ''Magazine-to-Magazine'', and ''Facility-to-Facility'' field trials. This paper will describe the evaluation exercise Sandia and VNIIEF conducted on the Magazine-to-Magazine systems. Topics covered will include a description of the evaluation philosophy, how the various sensors and system features were tested, evaluation results, and lessons learned

  1. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    Science.gov (United States)

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2018-01-01

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  2. Evaluation of Marfan patients status post valve-sparing aortic root replacement with 4D flow.

    Science.gov (United States)

    Hope, Thomas A; Kvitting, John-Peder Escobar; Hope, Michael D; Miller, D Craig; Markl, Michael; Herfkens, Robert J

    2013-11-01

    Over the past two decades elective valve-sparing aortic root replacement (V-SARR) has become more common in the treatment of patients with aortic root and ascending aortic aneurysms. Currently there are little data available to predict complications in the post-operative population. The study goal was to determine if altered flow patterns in the thoracic aorta, as measured by MRI, are associated with complications after V-SARR. Time-resolved three-dimensional phase-contrast MRI (4D flow) was used to image 12 patients with Marfan syndrome after V-SARR. The patients were followed up for an average of 5.8 years after imaging and 8.2 years after surgery. Additionally 5 volunteers were imaged for comparison. Flow profiles were visualized during peak systole using streamlines. Wall shear stress estimates and normalized flow displacement were evaluated at multiple planes in the thoracic aorta. During the follow-up period, a single patient developed a Stanford Type B aortic dissection. At initial imaging, prior to the development of the dissection, the patient had altered flow patterns, wall shear stress estimates, and increased normalized flow displacement in the thoracic aorta in comparison to the remaining V-SARR patients and volunteers. This is the first follow-up study of patients after 4D flow imaging. An aortic dissection developed in one patient with altered flow patterns and hemodynamic stresses in the thoracic aorta. These results suggest that flow and altered hemodynamics may play a role in the development of post-operative intramural hematomas and dissections. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Evaluation of early endoscopic realignment of post-traumatic complete posterior urethral rupture

    Directory of Open Access Journals (Sweden)

    Yaser M Abdelsalam

    2013-01-01

    Full Text Available Introduction: to report our experience with 41 patients treated by early endoscopic realignment of complete post-traumatic rupture urethra. Materials and Methods: The study includes patients presented to our institute, between May 2004 and April 2009, with post-traumatic complete posterior urethral disruption. Preoperative retrograde urethrography, voiding cystourethrography and abdominopelvic CT were performed to evaluate the urethral defect length, the bladder neck competence, the prostate position, and the extent of the pelvic hematoma. Within the first week after trauma, antegrade and retrograde urethroscopy were performed to identify both urethral ends and insert urethral catheter. Patients were followed up by pericatheter retrograde urethrogram monthly postoperatively till catheter removal on disappearance of extravasation. Retrograde urethrography, voiding cystourethrography and urethroscopy were performed 1 month after the removal of the catheter. Follow-up abdominal ultrasound and uroflowmetry monthly till 6 months, bimonthly till 1 year, and every 3 months thereafter were encouraged. Urinary continence and postoperative erectile dysfunction were assessed by direct patient interview. Results: Forty one patients in the age group 17-61 years (mean 37.9 were treated. Patients were followed up for 12-36 months (mean 17 months. Complete healing of the urethra occurred in 18 patients (43.9%. Passable urethral stricture developed in 15 patients (36.6%. Complete urethral obstruction occurred in eight patients (19.5%. Conclusions: Early endoscopic realignment for complete posterior urethral rupture is a feasible technique with no or minimal intraoperative complications. The technique is successful as the definitive line of therapy in reasonable number of patients and seems to render further future interventions for inevitable urethral stricture easier.

  4. Post-introduction economic evaluation of pneumococcal conjugate vaccination in Ecuador, Honduras, and Paraguay

    Directory of Open Access Journals (Sweden)

    Dagna O. Constenla

    Full Text Available OBJECTIVE:A decision-analytic model was constructed to evaluate the economic impact of post-introduction pneumococcal conjugate vaccine (PCV programs in Ecuador, Honduras, and Paraguay from the societal perspective. METHODS: Hypothetical birth cohorts were followed for a 20-year period in each country. Estimates of disease burden, vaccine effectiveness, and health care costs were derived from primary and secondary data sources. Costs were expressed in 2014 US$. Sensitivity analyses were performed to assess the impact of model input uncertainties. RESULTS: Over the 20 years of vaccine program implementation, the health care costs per case ranged from US$ 764 854 to more than US$ 1 million. Vaccination prevented more than 50% of pneumococcal cases and deaths per country. At a cost of US$ 16 per dose, the cost per disability-adjusted life year (DALY averted for the 10-valent PCV (PCV10 and the 13-valet PCV (PCV13 ranged from US$ 796 (Honduras to US$ 1 340 (Ecuador and from US$ 691 (Honduras to US$ 1 166 (Ecuador respectively. At a reduced price (US$ 7 per dose, the cost per DALY averted ranged from US$ 327 (Honduras to US$ 528 (Ecuador and from US$ 281 (Honduras to US$ 456 (Ecuador for PCV10 and PCV13 respectively. Several model parameters influenced the results of the analysis, including vaccine price, vaccine efficacy, disease incidence, and costs. CONCLUSIONS: The economic impact of post-introduction PCV needs to be assessed in a context of uncertainty regarding changing antibiotic resistance, herd and serotype replacement effects, differential vaccine prices, and government budget constraints.

  5. An evaluation of post-registration neuroscience focused education and neuroscience nurses' perceived educational needs.

    Science.gov (United States)

    Braine, Mary E; Cook, Neal

    2015-11-01

    People with complex neurological conditions require co-ordinated care provided by nurses educated in meeting service needs, understanding the pathophysiological processes of disease and the preparation to care for those with complex needs. However, evidence suggests that neuroscience specific education provision is largely unregulated and set outside of a cohesive professional development context. Furthermore, it largely seems to only address the induction phase into working within neurosciences. To evaluate the nature of post-registration neuroscience focused education across Europe and neuroscience nurses' perceived educational needs. Post qualifying nurses working in the field of neurosciences were invited to complete a self-reported 29-item on-line questionnaire that contained closed and open-ended questions exploring professional background, clinical and educational experience, educational opportunities available to them and their perspectives on their educational needs. 154 participants from fourteen countries across Europe completed the survey. 75% (n=110) of respondents had undertaken neuroscience focused education with the most accessible education opportunities found to be conferences 77% (n=96) and study days 69% (n=86). Overall, 52.6% of courses were multidisciplinary in nature, and 47.4% were exclusively nursing. Most identified that their courses were funded by their employer (57%, n=63) or partly funded by their employer. Results illustrate a significant variance across Europe, highlighting the need for more effective communication between neuroscience nurses across Europe. Implications for future education provision, recruitment/retention, and funding are discussed, resulting in recommendations for the future of neuroscience nursing. This study, the largest of its kind to survey neuroscience nurses, illustrates the absence of a cohesive career development pathway for neuroscience nurses in Europe. Nurses need quality assured specialist education to

  6. Post-introduction economic evaluation of pneumococcal conjugate vaccination in Ecuador, Honduras, and Paraguay.

    Science.gov (United States)

    Constenla, Dagna O

    2015-11-01

    A decision-analytic model was constructed to evaluate the economic impact of post-introduction pneumococcal conjugate vaccine (PCV) programs in Ecuador, Honduras, and Paraguay from the societal perspective. Hypothetical birth cohorts were followed for a 20-year period in each country. Estimates of disease burden, vaccine effectiveness, and health care costs were derived from primary and secondary data sources. Costs were expressed in 2014 US$. Sensitivity analyses were performed to assess the impact of model input uncertainties. Over the 20 years of vaccine program implementation, the health care costs per case ranged from US$ 764 854 to more than US$ 1 million. Vaccination prevented more than 50% of pneumococcal cases and deaths per country. At a cost of US$ 16 per dose, the cost per disability-adjusted life year (DALY) averted for the 10-valent PCV (PCV10) and the 13-valet PCV (PCV13) ranged from US$ 796 (Honduras) to US$ 1 340 (Ecuador) and from US$ 691 (Honduras) to US$ 1 166 (Ecuador) respectively. At a reduced price (US$ 7 per dose), the cost per DALY averted ranged from US$ 327 (Honduras) to US$ 528 (Ecuador) and from US$ 281 (Honduras) to US$ 456 (Ecuador) for PCV10 and PCV13 respectively. Several model parameters influenced the results of the analysis, including vaccine price, vaccine efficacy, disease incidence, and costs. The economic impact of post-introduction PCV needs to be assessed in a context of uncertainty regarding changing antibiotic resistance, herd and serotype replacement effects, differential vaccine prices, and government budget constraints.

  7. Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Reiss, Kate; Andersen, Kathryn; Barnard, Sharmani; Ngo, Thoai D; Biswas, Kamal; Smith, Christopher; Carpenter, James; Church, Kathryn; Nuremowla, Sadid; Pearson, Erin

    2017-10-03

    Adoption of modern contraceptive methods after menstrual regulation (MR) is thought to reduce subsequent unwanted pregnancy and abortion. Long-acting reversible contraceptives (LARCs) are highly effective at reducing unintended pregnancy, but uptake in Bangladesh is low. Providing information on the most effective methods of contraception increases uptake of more effective methods. This protocol describes a randomised controlled trial of an intervention delivered by mobile phone designed to support post-MR contraceptive use in Bangladesh. This is a multi-site single blind individual randomised controlled trial. At least 960 women undergoing MR procedures at selected facilities will be recruited after their procedure by female research assistants. Women will be randomised into the control or intervention group with a 1:1 ratio. All participants will receive usual clinic care, including contraceptive counselling and the telephone number of a non-toll-free call centre which provides counselling on MR and contraception. During the 4 months after their MR procedure, intervention participants will be sent 11 recorded interactive voice messages to their mobile phone about contraception with a focus on their chosen method and LARCs. Each message allows the participant to connect directly to the call centre. The intervention is free to the user. The control group will receive no messages delivered by mobile phone. All participants will be asked to complete an in-person questionnaire at recruitment and follow-up questionnaires by telephone at 2 weeks, 4 months and 12 months after their MR. The primary outcome for the trial will be self-reported LARC use 4 months post-MR. Secondary outcomes include LARC use at 2 weeks and 12 months post-MR, use of any effective modern contraceptive method at 2 weeks, 4 months and 12 months post-MR, and contraceptive discontinuation, contraceptive method switching, pregnancy, subsequent MR and experience of violence during the 12

  8. The effects of neuromuscular exercise on medial knee joint load post-arthroscopic partial medial meniscectomy: 'SCOPEX', a randomised control trial protocol

    DEFF Research Database (Denmark)

    Hall, Michelle; Hinman, Rana S; Wrigley, Tim V

    2012-01-01

    Meniscectomy is a risk factor for knee osteoarthritis, with increased medial joint loading a likely contributor to the development and progression of knee osteoarthritis in this group. Therefore, post-surgical rehabilitation or interventions that reduce medial knee joint loading have the potential...... to reduce the risk of developing or progressing osteoarthritis. The primary purpose of this randomised, assessor-blind controlled trial is to determine the effects of a home-based, physiotherapist-supervised neuromuscular exercise program on medial knee joint load during functional tasks in people who have...

  9. Effect of moderate alcohol consumption on fetuin-A levels in men and women: post-hoc analyses of three open-label randomized crossover trials

    NARCIS (Netherlands)

    Joosten, M.M.; Schrieks, I.C.; Hendriks, H.F.J.

    2014-01-01

    Background Fetuin-A, a liver-derived glycoprotein that impairs insulin-signalling, has emerged as a biomarker for diabetes risk. Although moderate alcohol consumption has been inversely associated with fetuin-A, data from clinical trials are lacking. Thus, we evaluated whether moderate alcohol

  10. The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan.

    Science.gov (United States)

    Delaney, Anthony P; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

    2013-09-01

    The Australasian Resuscitation in Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the emergency department with severe sepsis. In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and before completion of the two related international studies. Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and

  11. Post graduate clinical placements: evaluating benefits and challenges with a mixed methods cross sectional design.

    Science.gov (United States)

    Yiend, Jenny; Tracy, Derek K; Sreenan, Brian; Cardi, Valentina; Foulkes, Tina; Koutsantoni, Katerina; Kravariti, Eugenia; Tchanturia, Kate; Willmott, Lucy; Shergill, Sukhi; Reedy, Gabriel

    2016-02-16

    Systematic evaluations of clinical placements are rare, especially when offered alongside academic postgraduate courses. An evidence-based approach is important to allow pedagogically-driven provision, rather than that solely governed by opinion or market demand. Our evaluation assessed a voluntary clinical placement scheme allied to a mental health course. Data were collected over academic years 2010/11- 2013/14, from participating students (n = 20 to 58) and clinician supervisors (n = 10-12), using a mixed-methods cross-sectional design. Quantitative evaluation captured information on uptake, dropout, resource use, attitudes and experience, using standardized (the Placement Evaluation Questionnaire; the Scale To Assess the Therapeutic Relationship - Clinical version and the University of Toronto Placement Supervisor Evaluation) and bespoke questionnaires and audit data. Qualitative evaluation comprised two focus groups (5 clinicians, 5 students), to investigate attitudes, experience, perceived benefits, disadvantages and desired future developments. Data were analysed using framework analysis to identify a priori and emergent themes. High uptake (around 70 placements per annum), low dropout (2-3 students per annum; 5 %) and positive focus group comments suggested placements successfully provided added value and catered sufficiently to student demand. Students' responses confirmed that placements met expectations and the perception of benefit remained after completion with 70 % (n = 14) reporting an overall positive experience, 75 % (n = 15) reporting a pleasant learning experience, 60 % (n = 12) feeling that their clinical skills were enhanced and 85 % (n = 17) believing that it would benefit other students. Placements contributed the equivalent of seven full time unskilled posts per annum to local health care services. While qualitative data revealed perceived 'mutual benefit' for both students and clinicians, this was qualified by

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

    Science.gov (United States)

    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.

  13. Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial

    OpenAIRE

    Mansfield, Avril; Aqui, Anthony; Centen, Andrew; Danells, Cynthia J.; DePaul, Vincent G.; Knorr, Svetlana; Schinkel-Ivy, Alison; Brooks, Dina; Inness, Elizabeth L.; McIlroy, William E.; Mochizuki, George

    2015-01-01

    Background Falls are one of the most common medical complications post-stroke. Physical exercise, particularly exercise that challenges balance, reduces the risk of falls among healthy and frail older adults. However, exercise has not proven effective for preventing falls post-stroke. Falls ultimately occur when an individual fails to recover from a loss of balance. Thus, training to specifically improve reactive balance control could prevent falls. Perturbation training aims to improve react...

  14. A systems biology approach investigating the effect of probiotics on the vaginal microbiome and host responses in a double blind, placebo-controlled clinical trial of post-menopausal women.

    Directory of Open Access Journals (Sweden)

    Jordan E Bisanz

    Full Text Available A lactobacilli dominated microbiota in most pre and post-menopausal women is an indicator of vaginal health. The objective of this double blinded, placebo-controlled crossover study was to evaluate in 14 post-menopausal women with an intermediate Nugent score, the effect of 3 days of vaginal administration of probiotic L. rhamnosus GR-1 and L. reuteri RC-14 (2.5×109 CFU each on the microbiota and host response. The probiotic treatment did not result in an improved Nugent score when compared to when placebo. Analysis using 16S rRNA sequencing and metabolomics profiling revealed that the relative abundance of Lactobacillus was increased following probiotic administration as compared to placebo, which was weakly associated with an increase in lactate levels. A decrease in Atopobium was also observed. Analysis of host responses by microarray showed the probiotics had an immune-modulatory response including effects on pattern recognition receptors such as TLR2 while also affecting epithelial barrier function. This is the first study to use an interactomic approach for the study of vaginal probiotic administration in post-menopausal women. It shows that in some cases multifaceted approaches are required to detect the subtle molecular changes induced by the host to instillation of probiotic strains.ClinicalTrials.gov NCT02139839.

  15. Randomised controlled trial evaluation of Tweet2Quit: a social network quit-smoking intervention.

    Science.gov (United States)

    Pechmann, Cornelia; Delucchi, Kevin; Lakon, Cynthia M; Prochaska, Judith J

    2017-03-01

    We evaluated a novel Twitter-delivered intervention for smoking cessation, Tweet2Quit, which sends daily, automated communications to small, private, self-help groups to encourage high-quality, online, peer-to-peer discussions. A 2-group randomised controlled trial assessed the net benefit of adding a Tweet2Quit support group to a usual care control condition of nicotine patches and a cessation website. Participants were 160 smokers (4 cohorts of 40/cohort), aged 18-59 years, who intended to quit smoking, used Facebook daily, texted weekly, and had mobile phones with unlimited texting. All participants received 56 days of nicotine patches, emails with links to the smokefree.gov cessation website, and instructions to set a quit date within 7 days. Additionally, Tweet2Quit participants were enrolled in 20-person, 100-day Twitter groups, and received daily discussion topics via Twitter, and daily engagement feedback via text. The primary outcome was sustained abstinence at 7, 30 and 60 days post-quit date. Participants (mean age 35.7 years, 26.3% male, 31.2% college degree, 88.7% Caucasian) averaged 18.0 (SD=8.2) cigarettes per day and 16.8 (SD=9.8) years of smoking. Participants randomised to Tweet2Quit averaged 58.8 tweets/participant and the average tweeting duration was 47.4 days/participant. Tweet2Quit doubled sustained abstinence out to 60 days follow-up (40.0%, 26/65) versus control (20.0%, 14/70), OR=2.67, CI 1.19 to 5.99, p=0.017. Tweeting via phone predicted tweet volume, and tweet volume predicted sustained abstinence (p<0.001). The daily autocommunications caused tweeting spikes accounting for 24.0% of tweets. Tweet2Quit was engaging and doubled sustained abstinence. Its low cost and scalability makes it viable as a global cessation treatment. NCT01602536. 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/.

  16. A cluster-randomized controlled trial evaluating the effects of delaying onset of adolescent substance abuse on cognitive development and addiction following a selective, personality-targeted intervention programme: the Co-Venture trial.

    Science.gov (United States)

    O'Leary-Barrett, Maeve; Mâsse, Benoit; Pihl, Robert O; Stewart, Sherry H; Séguin, Jean R; Conrod, Patricia J

    2017-10-01

    Substance use and binge drinking during early adolescence are associated with neurocognitive abnormalities, mental health problems and an increased risk for future addiction. The trial aims to evaluate the protective effects of an evidence-based substance use prevention programme on the onset of alcohol and drug use in adolescence, as well as on cognitive, mental health and addiction outcomes over 5 years. Thirty-eight high schools will be recruited, with a final sample of 31 schools assigned to intervention or control conditions (3826 youth). Brief personality-targeted interventions will be delivered to high-risk youth attending intervention schools during the first year of the trial. Control school participants will receive no intervention above what is offered to them in the regular curriculum by their respective schools. Public/private French and English high schools in Montreal (Canada). All grade 7 students (12-13 years old) will be invited to participate. High-risk youth will be identified as those scoring one standard deviation or more above the school mean on one of the four personality subscales of the Substance Use Risk Profile Scale (40-45% youth). Self-reported substance use and mental health symptoms and cognitive functioning measured annually throughout 5 years. Primary outcomes are the onset of substance use disorders at 4 years post-intervention (year 5). Secondary intermediate outcomes are the onset of alcohol and substance use 2 years post-intervention and neuropsychological functions; namely, the protective effects of substance use prevention on cognitive functions generally, and executive functions and reward sensitivity specifically. This longitudinal, cluster-randomized controlled trial will investigate the impact of a brief personality-targeted intervention program on reducing the onset of addiction 4 years-post intervention. Results will tease apart the developmental sequences of uptake and growth in substance use and cognitive

  17. Phase II feasibility trial of adjuvant chemoradiotherapy with 3-weekly cisplatin for Japanese patients with post-operative high-risk squamous cell carcinoma of the head and neck

    International Nuclear Information System (INIS)

    Kiyota, Naomi; Tahara, Makoto; Okano, Susumu

    2012-01-01

    The current standard of care for post-operative high-risk squamous cell carcinoma of the head and neck is concurrent chemoradiotherapy with a 3-weekly cycle of cisplatin (3W-CDDP/RT). In previous pivotal trials, the complete delivery rate of three cycles of cisplatin and radiation therapy was only -60%. Here, we evaluated the feasibility and safety of 3W-CDDP/RT in a Japanese population. The study enrolled post-operative high-risk squamous cell carcinoma of the head and neck patients. High-risk factors were a microscopically incomplete resection, extracapsular extension and two or more lymph node metastases. Subjects received three cycles of cisplatin at a dose of 100 mg/m 2 concomitant with radiation therapy (66 Gy/33 Fr). From August 2006 to May 2009, 25 eligible subjects were accrued, including 13 males, with a median age of 59 years, Eastern Cooperative Oncology Group performance status 0/1 (18/7), Stage III/IVA/IVB/recurrent (1/18/1/5) and oral cavity/oropharynx/hypopharynx/larynx (17/4/3/1). Protocol completion rate was 80%. The lower limit of the one-sided 90% confidence interval was 66%, which met the predefined statistical criteria. Grade 3/4 acute and late toxicities were almost identical to those in previous pivotal trials. No treatment-related deaths were observed. With a median follow-up of 39 months, 14 have had progression and 10 have died. Estimated 3-year locoregional control rate, relapse-free survival and overall survival were 74, 43 and 60%, respectively. On univariate analysis, oral cavity cancer and a cumulative cisplatin dose below 240 mg/m 2 appeared to be poor prognostic factors. This is the first Phase II feasibility trial of adjuvant chemoradiotherapy with 3-weekly cisplatin for post-operative high-risk squamous cell carcinoma of the head and neck in a Japanese population. This treatment was feasible and the safety profile was identical to those in pivotal Phase III trials. (author)

  18. MRI evaluation of post-mastectomy irradiated breast implants: prevalence and analysis of complications.

    Science.gov (United States)

    Rella, L; Telegrafo, M; Nardone, A; Milella, A; Stabile Ianora, A A; Lioce, M; Angelelli, G; Moschetta, M

    2015-09-01

    To evaluate the effect of post-mastectomy radiation therapy (RT) on breast implants as detected by magnetic resonance imaging (MRI) searching for short-term complications. One hundred and forty patients (total of 144 implants) were evaluated by MRI; 80 (group 1) had undergone RT, whereas the remaining 60 patients (group 2) underwent mastectomy with implant reconstruction without RT. Two radiologists evaluated MRI images searching for implant rupture signs, sub-capsular seromas, capsular contracture, soft-tissue oedema, peri-implant fluid collections. Implant ruptures were classified as severe complications; seromas and capsular contractures as moderate complications; oedema and fluid collections as mild complications. The prevalence of MRI findings in the two groups was calculated and compared by unpaired t-test. Cohen's kappa statistics was used to assess interobserver agreement. Sixty-nine out of 144 (48%) implants presented pathological findings at MRI with complication rates of 47.5 and 48.4 for groups 1 and 2, respectively. Two (5%) severe complications, 10 (26%) moderate complications, and 26 (69%) mild complications occurred in group 1 and surgical treatment was performed in 10 cases. Two (6%) severe complications, seven (23%) moderate complications, and 22 (71%) mild complications occurred in group 2 and surgical treatment was performed in eight cases. No significant difference between the two groups was found (p>0.1). Almost perfect agreement between the two radiologists was found for MRI image detection (k=0.86). RT does not seem to cause a significant effect on breast implants in terms of complication rate in patients undergoing implant-based breast reconstruction. One-stage immediate implant-based breast reconstruction performed at the same time as mastectomy could be proposed. Copyright © 2015 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

  19. Role of 99mTc labelled GHA in post treatment evaluation of brain tumours

    International Nuclear Information System (INIS)

    Choudhury, P.

    2003-01-01

    noticed in scans done in the early post operative period. However delayed imaging (3-4hr post injection) had been helpful in such situations. Findings have correlated well with thallium scans in the group of patients who had both the studies. Conclusions: The mechanism of uptake of GHA by viable tumour cells has not been well documented. Breach in the blood brain barrier is one mechanism but whether the radiopharmaceutical is incorporated in the tumour cells or it also acts as a glucose analogue biologically, needs to be evaluated further. Tc-99m GHA is inexpensive, easy to procure and has shown promising results, at least in our hands. In our opinion, it can be a cost effective viability agent, hence needs further attention. (author)

  20. Evaluation of post-tensioning of a curved continuous girder using long-gauge fiber optic sensors

    Science.gov (United States)

    Abdel-Jaber, Hiba; Glisic, Branko

    2014-03-01

    Streicker Bridge is a pedestrian bridge on the Princeton University campus. It consists of a main span and four curved continuous girders (legs). The main span and the southeast leg of the bridge are equipped with fiber optic strain and temperature sensors, allowing the bridge to also function as an on-campus laboratory for the Structural Health Monitoring research group. Parallel sensors were embedded at critical cross-sections in the deck prior to the pouring of concrete. The deck of the southeast leg experienced early age cracking within a few days of concrete pouring, which was detected by the strain sensors. Post-tensioning was then performed and it is assumed that it closed off the cracks. Evaluation of post-tensioning forces is complex due to the existence of the cracks, and this paper researches a procedure to estimate the post-tensioning forces at cracked and uncracked locations. The obtained post-tensioning forces were compared to design forces and conclusions regarding the status of post-tensioning were made. This is important as it gives information on the actual health condition and performance of the structure. It also provides information on the safety of the structure. The objective of this paper is to present a methodology for the evaluation of the post-tensioning force along the deck based on strain measurements. The monitoring system, results, data analysis method, and conclusions regarding the bridge health condition and performance are presented in this paper.

  1. Evaluating Adaptation of a Cancer Clinical Trial Decision Aid for Rural Cancer Patients: A Mixed-Methods Approach.

    Science.gov (United States)

    Pathak, Swati; George, Nerissa; Monti, Denise; Robinson, Kathy; Politi, Mary C

    2018-06-03

    Rural-residing cancer patients often do not participate in clinical trials. Many patients misunderstand cancer clinical trials and their rights as participant. The purpose of this study is to modify a previously developed cancer clinical trials decision aid (DA), incorporating the unique needs of rural populations, and test its impact on knowledge and decision outcomes. The study was conducted in two phases. Phase I recruited 15 rural-residing cancer survivors in a qualitative usability study. Participants navigated the original DA and provided feedback regarding usability and implementation in rural settings. Phase II recruited 31 newly diagnosed rural-residing cancer patients. Patients completed a survey before and after using the revised DA, R-CHOICES. Primary outcomes included decisional conflict, decision self-efficacy, knowledge, communication self-efficacy, and attitudes towards and willingness to consider joining a trial. In phase I, the DA was viewed positively by rural-residing cancer survivors. Participants provided important feedback about factors rural-residing patients consider when thinking about trial participation. In phase II, after using R-CHOICES, participants had higher certainty about their choice (mean post-test = 3.10 vs. pre-test = 2.67; P = 0.025) and higher trial knowledge (mean percentage correct at post-test = 73.58 vs. pre-test = 57.77; P decision self-efficacy, communication self-efficacy, and attitudes towards or willingness to join trials. The R-CHOICES improved rural-residing patients' knowledge of cancer clinical trials and reduced conflict about making a trial decision. More research is needed on ways to further support decisions about trial participation among this population.

  2. Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Andrea Gago Martínez

    Full Text Available Non-steroidal anti-inflammatory drugs are often used as components of multimodal therapy for postoperative pain management, but their use is currently limited by its side effects. The specific objective of this study was to evaluate the efficacy and safety of a new formulation of intravenous (IV ibuprofen for the management of postoperative pain in a European population.A total of 206 patients from both abdominal and orthopedic surgery, were randomly assigned in 1:1 ratio to receive 800 mg IV-ibuprofen or placebo every 6 hours; all patients had morphine access through a patient controlled analgesia pump. The primary outcome measure was median morphine consumption within the first 24 hours following surgery. The mean±SEM of morphine requirements was reduced from 29,8±5,25 mg to 14,22±3,23 mg (p = 0,015 and resulted in a decrease in pain at rest (p = 0,02 measured by Visual Analog Scale (VAS from mean±SEM 3.34±0,35 to 0.86±0.24, and also in pain during movement (p = 0,02 from 4.32±0,36 to 1.90±0,30 in the ibuprofen treatment arm; while in the placebo group VAS score at rest ranged from 4.68±0,40 to 2.12±0,42 and during movement from 5.66±0,42 to 3.38±0,44. Similar treatment-emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events.Perioperative administration of IV-Ibuprofen 800 mg every 6 hours in abdominal surgery patient's decreases morphine requirements and pain score. Furthermore IV-Ibuprofen was safe and well tolerate. Consequently we consider appropriate that protocols for management of postoperative pain include IV-Ibuprofen 800 mg every 6 hours as an option to offer patients an analgesic benefit while reducing the potentially risks associated with morphine consumption.EU Clinical Trials Register 2011-005007-33.

  3. A review and additional post-hoc analyses of the incidence and impact of constipation observed in darifenacin clinical trials

    Directory of Open Access Journals (Sweden)

    Tack J

    2012-09-01

    Full Text Available Jan Tack,1 Jean-Jacques Wyndaele,2 Greg Ligozio,3 Mathias Egermark41University of Leuven, Gastroenterology Section, Leuven, 2University of Antwerp, Department of Urology, Antwerp, Belgium; 3Novartis Pharmaceuticals Corporation, NJ, USA; 4Roche Diagnostics Scandinavia AB, Bromma, Sweden and formerly of Novartis Pharma AG, Basel, SwitzerlandBackground: Constipation is a common side effect of antimuscarinic treatment for overactive bladder (OAB. This review evaluates the incidence and impact of constipation on the lives of patients with OAB being treated with darifenacin.Methods: Constipation data from published Phase III and Phase IIIb/IV darifenacin studies were reviewed and analyzed. Over 4000 patients with OAB (aged 18–89 years; ≥80% female enrolled in nine studies (three Phase III [data from these fixed-dose studies were pooled and provide the primary focus for this review], three Phase IIIb, and three Phase IV. The impact of constipation was assessed by discontinuations, use of concomitant laxatives, patient-reported perception of treatment, and a bowel habit questionnaire.Results: In the pooled Phase III trials, 14.8% (50/337 of patients on darifenacin 7.5 mg/day and 21.3% (71/334 on 15 mg/day experienced constipation compared with 12.6% (28/223 and 6.2% (24/388 with tolterodine and placebo, respectively. In addition, a few patients discontinued treatment due to constipation (0.6% [2/337], 1.2% [4/334], 1.8% [4/223], and 0.3% [1/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively, or required concomitant laxatives (3.3% [11/337], 6.6% [22/334], 7.2% [16/223], and 1.5% [6/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively. Patient-reported perception of treatment quality was observed to be similar between patients who experienced constipation and those who did not. During the long-term extension study, a bowel habit questionnaire showed only small

  4. Malignancies in children and young adults on etanercept: summary of cases from clinical trials and post marketing reports.

    Science.gov (United States)

    Hooper, Michele; Wenkert, Deborah; Bitman, Bojena; Dias, Virgil C; Bartley, Yessenia

    2013-10-02

    Malignancy risk may be increased in chronic inflammatory conditions that are mediated by tumor necrosis factor (TNF), such as juvenile idiopathic arthritis (JIA), but the role of TNF in human cancer biology is unclear. In response to a 2011 United States Food & Drug Administration requirement of TNF blocker manufacturers, we evaluated reporting rates of all malignancies in patients =30 years old who received the TNF blocker etanercept. All malignancies in etanercept-exposed patients aged =30 years from the Amgen clinical trial database (CTD) and postmarketing global safety database (PMD) were reviewed. PMD reporting rates were generated using exposure information based on commercial sources. Age-specific incidence rates of malignancy for the general US population were generated from the Surveillance Epidemiology and End Results (SEER) database v7.0.9. There were 2 malignancies in the CTD: 1 each in etanercept and placebo/comparator arms (both in patients 18-30 years old). Postmarketing etanercept exposure was 231,404 patient-years (62,379 patient-years in patients 0-17 years; 168,485 patient-years in patients 18-30 years). Reporting rates of malignancy per 100,000 patient-years in the PMD and incidence rates in SEER were 32.0 and 15.9, respectively, for patients 0-17 years and 46.9 and 42.1 for patients 18-30 years old. Reporting rates were higher than SEER incidence rates for Hodgkin lymphoma in the 0-17 years age group. PMD reporting rates per 100,000 patient-years and SEER incidence rates per 100,000 person-years for Hodgkin lymphoma were 9.54 and 0.9, respectively, for patients 0-17 years and 1.8 and 4.2 for patients 18-30 years old. There were =5 cases of leukemia, lymphoma, melanoma, thyroid, and cervical cancers. Leukemia, non-Hodgkin lymphoma, melanoma, thyroid cancer, and cervical cancer rates were similar in the PMD and SEER. Overall PMD malignancy reporting rates in etanercept-treated patients 0-17 years appeared higher than incidence rates in SEER

  5. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency.

    Science.gov (United States)

    Carpentier, Patrick H; Blaise, Sophie; Satger, Bernadette; Genty, Céline; Rolland, Carole; Roques, Christian; Bosson, Jean-Luc

    2014-02-01

    Apart from compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVDs). Spa treatment is a popular way to administer physical therapy for CVDs in France, but its efficacy has not yet been assessed in a large trial. The objective was to assess the efficacy of spa therapy for patients with advanced CVD (CEAP clinical classes C4-C5). This was a single-blind (treatment concealed to the investigators) randomized, multicenter, controlled trial (French spa resorts). Inclusion criteria were primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5). The treated group had the usual 3-week spa treatment course soon after randomization; the control group had spa treatment after the 1-year comparison period. All patients continued their usual medical care including wearing compression stockings. Treatment consisted of four balneotherapy sessions per day for 6 days a week. Follow-up was performed at 6, 12 and 18 months by independent blinded investigators. The main outcome criterion was the incidence of leg ulcers at 12 months. Secondary criteria were a modified version of the Venous Clinical Severity Score, a visual analog scale for leg symptoms, and the Chronic Venous Insufficiency Questionnaire 2 and EuroQol 5D quality-of-life autoquestionnaires. Four hundred twenty-five subjects were enrolled: 214 in the treatment group (Spa) and 211 in the control group (Ctr); they were similar at baseline regarding their demographic characteristics, the severity of the CVD, and the outcome variables. At 1 year, the incidence of leg ulcers was not statistically different (Spa: +9.3%; 95% confidence interval [CI], +5.6 - +14.3; Ctr: +6.1%; 95% CI, +3.2 - +10.4), whereas the Venous Clinical Severity Score improved significantly in the treatment group (Spa: -1.2; 95% CI, -1.6 - -0.8; Ctr: -0.6; 95% CI, -1.0 - -0.2; P = .04). A significant difference favoring spa treatment was found regarding symptoms after 1

  6. Protocol for the effect evaluation of independent medical evaluation after six months sick leave: a randomized controlled trial of independent medical evaluation versus treatment as usual in Norway

    Directory of Open Access Journals (Sweden)

    Elisabeth Husabo

    2017-06-01

    Full Text Available Abstract Background It has been discussed whether the relationship between a patient on sick leave and his/her general practitioner (GP is too close, as this may hinder the GP’s objective evaluation of need for sick leave. Independent medical evaluation involves an independent physician consulting the patient. This could lead to new perspectives on sick leave and how to follow-up the patient. Methods/design The current study is a randomized controlled trial in a Norwegian primary care context, involving an effect evaluation, a cost/benefit analysis, and a qualitative evaluation. Independent medical evaluation will be compared to treatment as usual, i.e., the physicians’ and social insurance agencies’ current management of long-term sick-listed patients. Individuals aged 18–65 years, sick listed by their GP and on full or partial sick leave for the past 6 months in Hordaland county will be included. Exclusion criteria are pregnancy, cancer, dementia or an ICD-10 diagnosis. A total sample of 3800 will be randomly assigned to either independent medical evaluation or treatment as usual. Official register data will be used to measure the primary outcome; change in sickness benefits at 7, 9 and 12 months. Sick listed in other counties will serve as a second control group, if appropriate under the “common trend” assumption. Discussion The Norwegian effect evaluation of independent medical evaluation after 6 months sick leave is a large randomized controlled trial, and the first of its kind, to evaluate this type of intervention as a means of getting people back to work after long-term sickness absence. Trial registration ClinicalTrials.gov NCT02524392 . Registered June 23, 2015.

  7. Effectiveness and economic evaluation of self-help educational materials for the prevention of smoking relapse: randomised controlled trial.

    Science.gov (United States)

    Blyth, Annie; Maskrey, Vivienne; Notley, Caitlin; Barton, Garry R; Brown, Tracey J; Aveyard, Paul; Holland, Richard; Bachmann, Max O; Sutton, Stephen; Leonardi-Bee, Jo; Brandon, Thomas H; Song, Fujian

    2015-07-01

    Most people who quit smoking successfully for a short period will return to smoking again in 12 months. A previous exploratory meta-analysis indicated that self-help booklets may be effective for smoking relapse prevention in unaided quitters. This study aimed to evaluate the effectiveness of a set of self-help educational booklets to prevent smoking relapse in people who had stopped smoking with the aid of behavioural support. This is an open, randomised controlled trial and qualitative process evaluation. Trial participants were randomly allocated to one of two groups, using a simple randomisation process without attempts to stratify by participant characteristics. The participant allocation was 'concealed' because the recruitment of quitters occurred before the random allocation. Short-term quitters were recruited from NHS Stop Smoking Clinics, and self-help educational materials were posted to study participants at home. A total of 1407 carbon monoxide (CO)-validated quitters at 4 weeks after quit date in NHS Stop Smoking Clinics. The trial excluded pregnant women and quitters who were not able to read the educational materials in English. Participants in the experimental group (n = 703) received a set of eight revised Forever Free booklets, and participants in the control group (n = 704) received a single leaflet that is currently given to NHS patients. Follow-up telephone interviews were conducted 3 and 12 months after quit date. The primary outcome was prolonged, CO-verified abstinence from months 4 to 12 during which time no more than five cigarettes were smoked. The secondary outcomes included self-reported abstinence during the previous 7 days at 3 and 12 months, CO-verified abstinence at 12 months, costs (NHS and NHS and participant medication costs perspectives) and quality-adjusted life-years. Logistic regression analyses were conducted to investigate effect-modifying variables. A simultaneous qualitative process evaluation was conducted to help

  8. Evaluation of up-posting influence on the performance of an SDI service

    International Nuclear Information System (INIS)

    Barros, A.C.T.M. de

    1980-01-01

    Up-posting as a tool in information retrieval is analysed for the CIN/CNEN - SDI system based on INIS tapes. Two SDI versions were processed at a time for a random sample of 200 interest profiles: one using up-posting, another one disregarding it. Results were compared and statistical analyses were done to estimate the effects of up-posting and to set criteria for proper use. The influence of up-posting in the average SONAR performance may be neglected while for individual profiles significant variations in precision and/or recall were found. (Author) [pt

  9. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  10. Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer

    International Nuclear Information System (INIS)

    Sueoka-Aragane, Naoko; Kobayashi, Naomi; Bonnard, Eric; Charbonnier, Colette; Yamamichi, Junta; Mizobe, Hideaki; Kimura, Shinya

    2015-01-01

    Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites

  11. A Diagnostic Post-Occupancy Evaluation of the Nacadia® Therapy Garden

    Science.gov (United States)

    Sidenius, Ulrik; Karlsson Nyed, Patrik; Linn Lygum, Victoria; K. Stigsdotter, Ulrika

    2017-01-01

    The design of the Nacadia® therapy garden is based on a model for evidence-based health design in landscape architecture (EBHDL). One element of the model is a diagnostic post-occupancy evaluation (DPOE), which has not previously been fully developed. The present study develops a generic DPOE for therapy gardens, with a focus on studying the effects of the design on patients’ health outcomes. This is done in order to identify successes and failures in the design. By means of a triangulation approach, the DPOE employs a mixture of methods, and data is interpreted corroborating. The aim of the present study is to apply the DPOE to the Nacadia® therapy garden. The results of the DPOE suggest that the design of the Nacadia® therapy garden fulfills its stated aims and objectives. The overall environment of the Nacadia ® therapy garden was experienced as protective and safe, and successfully incorporated the various elements of the nature-based therapy programme. The participants encountered meaningful spaces and activities which suited their current physical and mental capabilities, and the health outcome measured by EQ-VAS (self-estimated general health) indicated a significant increase. Some design failures were identified, of which visual exposure was the most noteworthy. The DPOE model presented appears to be efficient but would nonetheless profit from being validated by other cases. PMID:28783060

  12. A Diagnostic Post-Occupancy Evaluation of the Nacadia® Therapy Garden.

    Science.gov (United States)

    Sidenius, Ulrik; Karlsson Nyed, Patrik; Linn Lygum, Victoria; K Stigsdotter, Ulrika

    2017-08-05

    The design of the Nacadia® therapy garden is based on a model for evidence-based health design in landscape architecture (EBHDL). One element of the model is a diagnostic post-occupancy evaluation (DPOE), which has not previously been fully developed. The present study develops a generic DPOE for therapy gardens, with a focus on studying the effects of the design on patients' health outcomes. This is done in order to identify successes and failures in the design. By means of a triangulation approach, the DPOE employs a mixture of methods, and data is interpreted corroborating. The aim of the present study is to apply the DPOE to the Nacadia® therapy garden. The results of the DPOE suggest that the design of the Nacadia® therapy garden fulfills its stated aims and objectives. The overall environment of the Nacadia ® therapy garden was experienced as protective and safe, and successfully incorporated the various elements of the nature-based therapy programme. The participants encountered meaningful spaces and activities which suited their current physical and mental capabilities, and the health outcome measured by EQ-VAS (self-estimated general health) indicated a significant increase. Some design failures were identified, of which visual exposure was the most noteworthy. The DPOE model presented appears to be efficient but would nonetheless profit from being validated by other cases.

  13. Post occupancy evaluation of energy-efficient behavior in informal housing of high density area

    Science.gov (United States)

    Aulia, D. N.; Marpaung, B. O. Y.

    2018-02-01

    The concept of energy-efficient building emphasizes the critical of efficiency in the use of water, electrical energy, and building materials, beginning with design, construction, to the maintenance of the building in the future. This study was conducted to observe the behavior of Energy Saving of the residents in performing everyday activities in the building. The observed variables are the consumption of natural resources (energy, material, water, and land) and the emissions of air, water, and land related to the environment and health. This research is a descriptive qualitative research with the method of data collection is the distribution of questionnaires and observation. The method of analyzing data is posted occupancy evaluation undertaken to obtain patterns of community-based behavior in urban areas. The informal high-density housing area is a typology of population settlements that found in many big cities in Indonesia. This community represents various community groups regarding occupation, education, income, and race. The results of the study concluded that there are five components of energy-saving behavioral formers in housing namely: residential building components, environmental components in occupancy, external occupancy components, components of social activities and elements of business

  14. Exploring mobility & workplace choice in a flexible office through post-occupancy evaluation.

    Science.gov (United States)

    Göçer, Özgür; Göçer, Kenan; Ergöz Karahan, Ebru; İlhan Oygür, Işıl

    2018-02-01

    Developments in information and communication systems, organisational structure and the nature of work have contributed to the restructuring of work environments. In these new types of work environments, employees do not have assigned workplaces. This arrangement helps organisations to minimise rent costs and increase employee interaction and knowledge exchange through mobility. This post-occupancy evaluation (POE) study focuses on a flexible office in a Gold Leadership in Energy and Environmental Design-certified building in Istanbul. An integrated qualitative and quantitative POE technique with occupancy tracking via barcode scanning and instant surveying has been introduced. Using this unique approach, we examined the directives/drivers in workplace choice and mobility from different perspectives. The aggregated data was used to discern work-related consequences such as flexibility, workplace choice, work and indoor environment satisfaction, place attachment and identity. The results show that employees who have a conventional working culture develop a new working style: 'fixed-flexible working'. Practitioner Summary: This paper introduces a new POE approach for flexible offices based on occupancy tracking through barcode scanning to explore workplace choice and mobility. More than half (52.1%) of the participants have tended to choose the same desk every day. However, the satisfaction level of the 'mobile' employees was higher than that of the 'fixed flexible' employees.

  15. Preoperative and post-operative sleep quality evaluation in rotator cuff tear patients.

    Science.gov (United States)

    Serbest, Sancar; Tiftikçi, Uğur; Askın, Aydogan; Yaman, Ferda; Alpua, Murat

    2017-07-01

    The aim of this study was to examine the potential relationship between subjective sleep quality and degree of pain in patients with rotator cuff repair. Thirty-one patients who underwent rotator cuff repair prospectively completed the Pittsburgh Sleep Quality Index, the Western Ontario Rotator Cuff Index, and the Constant and Murley shoulder scores before surgery and at 6 months after surgery. Preoperative demographic, clinical, and radiologic parameters were also evaluated. The study analysed 31 patients with a median age of 61 years. There was a significant difference preoperatively versus post-operatively in terms of all PSQI global scores and subdivisions (p Rotator Cuff Scale and the Constant and Murley shoulder scores (p ˂ 0.001). Sleep disorders are commonly seen in patients with rotator cuff tear, and after repair, there is an increase in the quality of sleep with a parallel improvement in shoulder functions. However, no statistically significant correlation was determined between arthroscopic procedures and the size of the tear and sleep quality. It is suggested that rotator cuff tear repair improves the quality of sleep and the quality of life. IV.

  16. Preliminary evaluation of PTSD Coach, a smartphone app for post-traumatic stress symptoms.

    Science.gov (United States)

    Kuhn, Eric; Greene, Carolyn; Hoffman, Julia; Nguyen, Tam; Wald, Laura; Schmidt, Janet; Ramsey, Kelly M; Ruzek, Josef

    2014-01-01

    PTSD Coach is a mobile application (app) designed to help individuals who have post-traumatic stress disorder (PTSD) symptoms better understand and self-manage their symptoms. It has wide-scale use (over 130,000 downloads in 78 countries) and very favorable reviews but has yet to be evaluated. Therefore, this study examines user satisfaction, perceived helpfulness, and usage patterns of PTSD Coach in a sample of 45 veterans receiving PTSD treatment. After using PTSD Coach for several days, participants completed a survey of satisfaction and perceived helpfulness and focus groups exploring app use and benefit from use. Data indicate that participants were very satisfied with PTSD Coach and perceived it as being moderately to very helpful with their PTSD symptoms. Analysis of focus group data resulted in several categories of app use: to manage acute distress and PTSD symptoms, at scheduled times, and to help with sleep. These findings offer preliminary support for the acceptability and perceived helpfulness of PTSD Coach and suggest that it has potential to be an effective self-management tool for PTSD. Although promising, future research is required to validate this, given study limitations. Reprint & Copyright © 2014 Association of Military Surgeons of the U.S.

  17. Advanced musculoskeletal physiotherapists in post arthroplasty review clinics: a state wide implementation program evaluation.

    Science.gov (United States)

    Harding, Paula; Burge, Angela; Walter, Kerrie; Shaw, Bridget; Page, Carolyn; Phan, Uyen; Terrill, Desiree; Liew, Susan

    2018-03-01

    To evaluate outcomes following a state-wide implementation of post arthroplasty review (PAR) clinics for patients following total hip and knee arthroplasty, led by advanced musculoskeletal physiotherapists in collaboration with orthopaedic specialists. A prospective observational study analysed data collected by 10 implementation sites (five metropolitan and five regional/rural centres) between September 2014 and June 2015. The Victorian Innovation and Reform Impact Assessment Framework was used to assess efficiency, effectiveness (access to care, safety and quality, workforce capacity, utilisation of skill sets, patient and workforce satisfaction) and sustainability (stakeholder engagement, succession planning and availability of ongoing funding). 2362 planned occasions of service (OOS) were provided for 2057 patients. Reduced patient wait times from referral to appointment were recorded and no adverse events occurred. Average cost savings across 10 sites was AUD$38 per OOS (Baseline $63, PAR clinic $35), representing a reduced pathway cost of 44%. Average annual predicted total value of increased orthopaedic specialist capacity was $11,950 per PAR clinic (range $6149 to $23,400). The Australian Orthopaedic Association review guidelines were met (8/10 sites, 80%) and patient-reported outcome measures were introduced as routine clinical care. High workforce and patient satisfaction were expressed. Eighteen physiotherapists were trained creating a sustainable workforce. Eight sites secured ongoing funding. The PAR clinics delivered a safe, cost-efficient model of care that improved patient access and quality of care compared to traditional specialist-led workforce models. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  18. Evaluation of post-LOCA long term cooling performance in Korean standard nuclear power plants

    International Nuclear Information System (INIS)

    Bang, Young Seok; Jung, Jae Won; Seul, Kwang Won; Kim, Hho Jung

    2001-01-01

    The post-LOCA long term cooling (LTC) performance of the Korean Standard Nuclear Power Plant (KSNPP) is analyzed for both small break loss-of-coolant accidents (LOCA) and large break LOCA at cold leg. The RELAP5/MOD3.2.2 beta code is used to calculate the LTC sequences based on the LTC plan of the Korean Standard Nuclear Power Plants (KSNPP). A standard input model is developed such that LOCA and the followed LTC sequence can be calculated in a single run for both small break LOCA and large break LOCA. A spectrum of small break LOCA ranging from 0.02 to 0.5 ft 2 of break area and a double-ended guillotine break are analyzed. Through the code calculations, the thermal-hydraulic behavior and the boron behavior are evaluated and the effect of the important action including the safety injection tank (SIT) isolation and the simultaneous injection in LTC procedure is investigated. As a result, it is found that the sufficient margin is available in avoiding the boron precipitation in the core. It is also found that a further specific condition for the SIT isolation action need to be setup and it is recommended that the early initiation of the simultaneous injection be taken for larger break LTC sequences. (author)

  19. Evaluation of microbial dynamics during post-consumption food waste composting.

    Science.gov (United States)

    Awasthi, Sanjeev Kumar; Wong, Jonathan W C; Li, Jiao; Wang, Quan; Zhang, Zengqiang; Kumar, Sunil; Awasthi, Mukesh Kumar

    2018-03-01

    The objective of present study was to evaluate the efficacy of bacterial consortium to boost the microbial population and enzyme activities during post-consumption food waste (PCFWs) composting. Three treatments of PCFWs mixed with saw dust and 10% zeolite (dry weight basis) was design, where treatments T-2 and T-3 were applied with two distinctive bacterial consortium, respectively, while T-1 was served as control. The results showed that total aerobic proteolytic, amylolytic, cellulolytic, oil degrading and total aerobic bacteria populations were significantly higher in treatment T2 and T3 than T1. Consequently, the selected hydrolytic enzymes were also higher in T2 and T3 than T1, whose apparently gave the interesting information about rate of decomposition and end product stability. Furthermore, T2 and T3 showed significant correlations between the enzymatic activities and microbial population with other physico-chemical parameters. Based on germination assays and CO 2 -C evolution rate, T2 and T3 were considered phytotoxic free and highly stable final compost on day 56. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. POST-OCCUPACY EVALUATION AND SOCIAL RESPONSABILITY: A RELATIONSHIP TO BE (RE DISCUSSED ALWAYS

    Directory of Open Access Journals (Sweden)

    Gleice Virginia Medeiros de Azambuja Elali

    2010-11-01

    Full Text Available Now a day, the importance of research activities for the development of all fields of the knowledge creates a preoccupation with ethical and social responsibility issues, aspects that cannot be ignored by researchers. Based on this context, this article focuses on researches of Post-Occupation Evaluation (POE, which are more and more present in Architecture and Urbanism, with the objective of subsidizing modification of buildings and new projects. In general, the paper shows the importance of the area to invest in the consolidation of the ethical positioning of researchers, position that will influence all stages of the research work, since the definition of the thematic cut-outs and the methods/techniques for accomplishment of the empirical studies, until presentation of results. Finally, the paper defends the necessity to value/strengthen the role of universities and research institutions’ ethics committees in the regulation of scientific inquiry process. It also points out the importance of defining sensible subcommittees to the specificities of Architecture and Urbanism field.

  1. Rooftop hospital gardens for physical therapy: a post-occupancy evaluation.

    Science.gov (United States)

    Davis, Brad E

    2011-01-01

    The goal of this study was to understand successes and weaknesses of a rooftop hospital garden used primarily for physical therapy. Literature on the healing benefits of nature and designed outdoor spaces in healthcare contexts continues to become more focused on specific patient populations. This study contributes to the knowledge of rooftop hospital gardens and gardens for physical rehabilitation. A post-occupancy evaluation was conducted using interviews with a lead therapist and landscape architect, behavior mapping, a staff survey, and a patient questionnaire. The designer and administrative staff perceived high accessibility while patients and staff reported low accessibility. Patients reported high satisfaction with the garden while staff reported little time for garden use. Poor maintenance decisions resulted in decreased functional and aesthetic value. Garden elements take on added layers of meaning and value to users seeking to escape the indoor environment, placing increased importance on evidence-based site design. Multiple perspectives must be considered in facility and garden master planning. Finally, designers and horticultural therapists must be retained in garden management to preserve and enhance garden functionality.

  2. Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    A R Prabhakar

    2015-01-01

    Full Text Available Context: The survival of atraumatic restorative treatment (ART restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. Aims: To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Settings and Designs: Experimental, in vivo intergroup split mouth, randomized clinical trial. Subjects and Methods: The study included Group I (Control, Group II (A. vera and Group III (propolis. Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Statistical Analysis Used: Repeated measures of analysis of variance (ANOVA with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. Results: In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Conclusions: Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry.

  3. MRI evaluation of post-mastectomy irradiated breast implants: prevalence and analysis of complications

    International Nuclear Information System (INIS)

    Rella, L.; Telegrafo, M.; Nardone, A.; Milella, A.; Ianora, A.A. Stabile; Lioce, M.; Angelelli, G.; Moschetta, M.

    2015-01-01

    Aim: To evaluate the effect of post-mastectomy radiation therapy (RT) on breast implants as detected by magnetic resonance imaging (MRI) searching for short-term complications. Materials and methods: One hundred and forty patients (total of 144 implants) were evaluated by MRI; 80 (group 1) had undergone RT, whereas the remaining 60 patients (group 2) underwent mastectomy with implant reconstruction without RT. Two radiologists evaluated MRI images searching for implant rupture signs, sub-capsular seromas, capsular contracture, soft-tissue oedema, peri-implant fluid collections. Implant ruptures were classified as severe complications; seromas and capsular contractures as moderate complications; oedema and fluid collections as mild complications. The prevalence of MRI findings in the two groups was calculated and compared by unpaired t-test. Cohen's kappa statistics was used to assess interobserver agreement. Results: Sixty-nine out of 144 (48%) implants presented pathological findings at MRI with complication rates of 47.5 and 48.4 for groups 1 and 2, respectively. Two (5%) severe complications, 10 (26%) moderate complications, and 26 (69%) mild complications occurred in group 1 and surgical treatment was performed in 10 cases. Two (6%) severe complications, seven (23%) moderate complications, and 22 (71%) mild complications occurred in group 2 and surgical treatment was performed in eight cases. No significant difference between the two groups was found (p>0.1). Almost perfect agreement between the two radiologists was found for MRI image detection (k=0.86). Conclusion: RT does not seem to cause a significant effect on breast implants in terms of complication rate in patients undergoing implant-based breast reconstruction. One-stage immediate implant-based breast reconstruction performed at the same time as mastectomy could be proposed. -- Highlights: •RT could increase complication rates of implant-based breast reconstruction (IBR). •No general consensus

  4. Evaluation of data on the transfer of radionuclides in the food chain post-Chernobyl action

    International Nuclear Information System (INIS)

    Desmet, G.; Sinnaeve, J.

    1992-01-01

    During the accident at Chernobyl large amounts of radioactive materials were released into the atmosphere and distributed all over Europe. Depending on the trajectories of the radioactive clouds and the large variation of rainfall during its passage through, large local and regional differences in deposition were observed, leading to an enhanced contamination of soil and plants. Consequently, the radionuclides entered the foodchain by several pathways. The radiological consequences of radionuclides discharged from nuclear installations usually are evaluated using doses assessment models. In these models the passage from one compartment into another, e.g. the transfer from soil into plants, from plants into milk or meat is defined by transfer factors, which are influenced by various parameters. From the long term point of view only the long-lived nuclides like 134/137 Cs are important for long term radiation risk assessment after the Chernobyl accident. In this accident the release of radioactive materials took place over a longer time period and varied in rate and radionuclide composition. Some regions of Europe were contaminated several times. To improve radiation dose prediction the CEC has initiated the Post-Chernobyl radiation protection programme 'Evaluation of Data on the Transfer of Radionuclides in the Foodchain' including five main items to be studied by different laboratories: 1. Impact of chemical speciation on the radionuclide transfer in terrestrial ecosystems after a core disruptive accident, especially in soils and plants. 2. Transfer paths of radionuclides in seminatural and natural ecosystems and their role in contaminating the foodchain. 3. Validation of soil-to-plant parameters. 4. Transfer of radionuclides to animals and animal products. 5. Transfer paths in aquatic systems and their importance for the contamination of the foodchain

  5. Tracking replicability as a method of post-publication open evaluation

    Directory of Open Access Journals (Sweden)

    Joshua eHartshorne

    2012-03-01

    Full Text Available Recent reports have suggested that many published results are unreliable. To increase the reliability and accuracy of published papers, multiple changes have been proposed, such as changes in statistical methods. We support such reforms. However, we believe that the incentive structure of scientific publishing must change for such reforms to be successful. Under the current system, the quality of individual scientists is judged on the basis of their number of publications and citations, with journals similarly judged via numbers of citations. Neither of these measures takes into account the replicability of the published findings, as false or controversial results are often particularly widely cited. We propose tracking replications as a means of post-publication evaluation, both to help researchers identify reliable findings and to incentivize the publication of reliable results.Tracking replications requires a database linking published studies that replicate one another. As any such database is limited by the number of replication attempts published, we propose establishing an open-access journal dedicated to publishing replication attempts. Data quality of both the database and the affiliated journal would be ensured through a combination of crowd-sourcing and peer review. As reports in the database are aggregated, ultimately it will be possible to calculate replicability scores, which may be used alongside citation counts to evaluate the quality of work published in individual journals. In this paper, we lay out a detailed description of how this system could be implemented, including mechanisms for compiling the information, ensuring data quality, and incentivizing the research community to participate.

  6. A randomized controlled trial of the effectiveness of multisystemic therapy in the Netherlands: post-treatment changes and moderator effects

    NARCIS (Netherlands)

    Asscher, J.J.; Dekovic, M.; Manders, W.A.; Prins, P.J.M.; van der Laan, P.H.

    2013-01-01

    Objective: In the present randomized controlled trial, the effectiveness of multisystemic therapy (MST) in The Netherlands was examined. Moderator tests were conducted for ethnicity, age and gender. Methods: The sample consisted of N = 256 adolescents, referred because of conduct problems, and

  7. A randomized controlled trial of the effectiveness of multisystemic therapy in the Netherlands: post-treatment changes and moderator effects

    NARCIS (Netherlands)

    Asscher, J.J.; Deković, M.; Manders, W.A.; van der Laan, P.H.; Prins, P.J.M.

    2013-01-01

    Objective: In the present randomized controlled trial, the effectiveness of multisystemic therapy (MST) in The Netherlands was examined. Moderator tests were conducted for ethnicity, age and gender. Methods: The sample consisted of N = 256 adolescents, referred because of conduct problems, and

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

    Science.gov (United States)

    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.

  9. The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.

    Science.gov (United States)

    Masterson-Algar, Patricia; Burton, Christopher R; Brady, Marian C; Nicoll, Avril; Clarke, Carl E; Rick, Caroline; Hughes, Max; Au, Pui; Smith, Christina H; Sackley, Catherine M

    2017-08-29

    The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. ISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.

  10. A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

    Directory of Open Access Journals (Sweden)

    Marrone Gaetano

    2011-07-01

    Full Text Available Abstract Background Many newly screened people living with HIV (PLHIV in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400 from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills, the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1. No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by

  11. Post-stroke Rehabilitation Training with a Motor-Imagery-Based Brain-Computer Interface (BCI-Controlled Hand Exoskeleton: A Randomized Controlled Multicenter Trial

    Directory of Open Access Journals (Sweden)

    Alexander A. Frolov

    2017-07-01

    Full Text Available Repeated use of brain-computer interfaces (BCIs providing contingent sensory feedback of brain activity was recently proposed as a rehabilitation approach to restore motor function after stroke or spinal cord lesions. However, there are only a few clinical studies that investigate feasibility and effectiveness of such an approach. Here we report on a placebo-controlled, multicenter clinical trial that investigated whether stroke survivors with severe upper limb (UL paralysis benefit from 10 BCI training sessions each lasting up to 40 min. A total of 74 patients participated: median time since stroke is 8 months, 25 and 75% quartiles [3.0; 13.0]; median severity of UL paralysis is 4.5 points [0.0; 30.0] as measured by the Action Research Arm Test, ARAT, and 19.5 points [11.0; 40.0] as measured by the Fugl-Meyer Motor Assessment, FMMA. Patients in the BCI group (n = 55 performed motor imagery of opening their affected hand. Motor imagery-related brain electroencephalographic activity was translated into contingent hand exoskeleton-driven opening movements of the affected hand. In a control group (n = 19, hand exoskeleton-driven opening movements of the affected hand were independent of brain electroencephalographic activity. Evaluation of the UL clinical assessments indicated that both groups improved, but only the BCI group showed an improvement in the ARAT's grasp score from 0 [0.0; 14.0] to 3.0 [0.0; 15.0] points (p < 0.01 and pinch scores from 0.0 [0.0; 7.0] to 1.0 [0.0; 12.0] points (p < 0.01. Upon training completion, 21.8% and 36.4% of the patients in the BCI group improved their ARAT and FMMA scores respectively. The corresponding numbers for the control group were 5.1% (ARAT and 15.8% (FMMA. These results suggests that adding BCI control to exoskeleton-assisted physical therapy can improve post-stroke rehabilitation outcomes. Both maximum and mean values of the percentage of successfully decoded imagery-related EEG activity, were higher

  12. Enzalutamide in Japanese patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer: A post-hoc analysis of the placebo-controlled PREVAIL trial.

    Science.gov (United States)

    Kimura, Go; Yonese, Junji; Fukagai, Takashi; Kamba, Tomomi; Nishimura, Kazuo; Nozawa, Masahiro; Mansbach, Hank; Theeuwes, Ad; Beer, Tomasz M; Tombal, Bertrand; Ueda, Takeshi

    2016-05-01

    To evaluate the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients. This was a post-hoc analysis of the phase 3, double-blind, placebo-controlled PREVAIL trial. Asymptomatic or mildly symptomatic chemotherapy-naïve patients with metastatic castration-resistant prostate cancer progressing on androgen deprivation therapy were randomized one-to-one to 160 mg/day oral enzalutamide or placebo until discontinuation on radiographic progression or skeletal-related event and initiation of subsequent antineoplastic therapy. Coprimary end-points were centrally assessed radiographic progression-free survival and overall survival. Secondary end-points were investigator-assessed radiographic progression-free survival, time to initiation of chemotherapy, time to prostate-specific antigen progression, prostate-specific antigen response (≥50% decline) and time to skeletal-related event. Of 1717 patients, 61 were enrolled in Japan (enzalutamide, n = 28; placebo, n = 33); hazard ratios (95% confidence interval) of 0.30 for centrally assessed radiographic progression-free survival (0.03-2.95), 0.59 for overall survival (0.20-1.8), 0.46 for time to chemotherapy (0.22-0.96) and 0.36 for time to prostate-specific antigen progression (0.17-0.75) showed the treatment benefit of enzalutamide over the placebo. Prostate-specific antigen responses were observed in 60.7% of enzalutamide-treated men versus 21.2% of placebo-treated men. Plasma concentrations of enzalutamide were higher in Japanese patients: the geometric mean ratio of Japanese/non-Japanese patients was 1.126 (90% confidence interval 1.018-1.245) at 13 weeks. Treatment-related adverse events grade ≥3 occurred in 3.6% of enzalutamide- and 6.1% of placebo-treated Japanese patients. Treatment effects and safety in Japanese patients were generally consistent with the overall results from PREVAIL. © 2016 The Authors. International Journal of Urology published by John Wiley & Sons Australia, Ltd on

  13. Using Poisson-gamma model to evaluate the duration of recruitment process when historical trials are available.

    Science.gov (United States)

    Minois, Nathan; Lauwers-Cances, Valérie; Savy, Stéphanie; Attal, Michel; Andrieu, Sandrine; Anisimov, Vladimir; Savy, Nicolas

    2017-10-15

    At the design of clinical trial operation, a question of a paramount interest is how long it takes to recruit a given number of patients. Modelling the recruitment dynamics is the necessary step to answer this question. Poisson-gamma model provides very convenient, flexible and realistic approach. This model allows predicting the trial duration using data collected at an interim time with very good accuracy. A natural question arises: how to evaluate the parameters of recruitment model before the trial begins? The question is harder to handle as there are no recruitment data available for this trial. However, if there exist similar completed trials, it is appealing to use data from these trials to investigate feasibility of the recruitment process. In this paper, the authors explore the recruitment data of two similar clinical trials (Intergroupe Francais du Myélome 2005 and 2009). It is shown that the natural idea of plugging the historical rates estimated from the completed trial in the same centres of the new trial for predicting recruitment is not a relevant strategy. In contrast, using the parameters of a gamma distribution of the rates estimated from the completed trial in the recruitment dynamic model of the new trial provides reasonable predictive properties with relevant confidence intervals. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  14. The association between retrospective outcome evaluations and pre-post-treatment changes in psychodynamic group-psychotherapy

    DEFF Research Database (Denmark)

    Jensen, Hans Henrik; Mortensen, Erik Lykke; Lotz, Martin

    2008-01-01

    In the present study of 203 patients in psychodynamic group psychotherapy, we explore associations between patient and therapist global retrospective outcome evaluations (ROE), and pre-post-treatment changes on the Symptom Check List 90 Revised (SCL-90-R) and non-symptomatic focus of therapy. The......, and associated with personality factors or domains not captured by standard questionnaires....

  15. Evaluation of an Innovative Interest-Based Post-School Transition Programme for Young People with Autism Spectrum Disorder

    Science.gov (United States)

    Ashburner, Jill K.; Bobir, Natasha I.; van Dooren, Kate

    2018-01-01

    After leaving school, young people with autism spectrum disorder often struggle with social, educational and employment participation. A post-school transition programme underpinned by individualised case management, where mentees are guided to complete self-selected projects by mentors with multimedia skills, was evaluated using a qualitative…

  16. Hypothermia after cardiac arrest should be further evaluated-A systematic review of randomised trials with meta-analysis and trial sequential analysis

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Friberg, Hans; Gluud, Christian

    2011-01-01

    BACKGROUND: Guidelines recommend mild induced hypothermia (MIH) to reduce mortality and neurological impairment after out-of-hospital cardiac arrest. Our objective was to systematically evaluate the evidence for MIH taking into consideration the risks of systematic and random error and to GRADE...... the evidence. METHODS: Systematic review with meta-analysis and trial sequential analysis of randomised trials evaluating MIH after cardiac arrest in adults. We searched CENTRAL, MEDLINE, and EMBASE databases until May 2009. Retrieved trials were evaluated with Cochrane methodology. Meta-analytic estimates....... The substantial risk of bias and concerns with directness rated down the quality of the evidence to low. CONCLUSIONS: Evidence regarding MIH after out-of-hospital cardiac arrest is still inconclusive and associated with non-negligible risks of systematic and random errors. Using GRADE-methodology, we conclude...

  17. A randomized comparative trial of combinational methods for preventing post-spinal hypotension at elective cesarean delivery

    Directory of Open Access Journals (Sweden)

    Mitra Jabalameli

    2011-01-01

    Conclusions: Among the three studied methods, administration of ephedrine plus bandage of the lower extremities was the most effective one in reducing the incidence of post-spinal hypotension. The groups were not clinically different concerning the effect of treatment on newborn health.

  18. Survival in Malnourished Older Patients Receiving Post-Discharge Nutritional Support; Long-Term Results of a Randomized Controlled Trial

    NARCIS (Netherlands)

    Neelemaat, F; van Keeken, S; Langius, J A E; de van der Schueren, M A E; Thijs, A; Bosmans, J E

    2017-01-01

    BACKGROUND: Previous analyses have shown that a post-discharge individualized nutritional intervention had positive effects on body weight, lean body mass, functional limitations and fall incidents in malnourished older patients. However, the impact of this intervention on survival has not yet been

  19. Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lee, Anne W.M. [Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Shenzhen (China); Vermorken, Jan B. [Department of Medical Oncology, Antwerp University Hospital, Edegem (Belgium); Wee, Joseph [Department of Radiation Oncology, National Cancer Centre Singapore (Singapore); O' Sullivan, Brian [Department of Radiation Oncology, University of Toronto, Ontario Cancer Institute, University Health Network, Toronto, Ontario (Canada); Eisbruch, Avraham [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Lin, Jin-Ching [Department of Radiation Oncology, Taichung Veterans General Hospital, Taichung, Taiwan (China); Mai, Hai-Qiang [Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Zhang, Li [Department of Medical Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Guo, Ying [Clinical Trials Centre, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lin, Ai-Hua [Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou (China); Sun, Ying [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); and others

    2017-05-01

    Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

  20. Likelihood-based methods for evaluating principal surrogacy in augmented vaccine trials.

    Science.gov (United States)

    Liu, Wei; Zhang, Bo; Zhang, Hui; Zhang, Zhiwei

    2017-04-01

    There is growing interest in assessing immune biomarkers, which are quick to measure and potentially predictive of long-term efficacy, as surrogate endpoints in randomized, placebo-controlled vaccine trials. This can be done under a principal stratification approach, with principal strata defined using a subject's potential immune responses to vaccine and placebo (the latter may be assumed to be zero). In this context, principal surrogacy refers to the extent to which vaccine efficacy varies across principal strata. Because a placebo recipient's potential immune response to vaccine is unobserved in a standard vaccine trial, augmented vaccine trials have been proposed to produce the information needed to evaluate principal surrogacy. This article reviews existing methods based on an estimated likelihood and a pseudo-score (PS) and proposes two new methods based on a semiparametric likelihood (SL) and a pseudo-likelihood (PL), for analyzing augmented vaccine trials. Unlike the PS method, the SL method does not require a model for missingness, which can be advantageous when immune response data are missing by happenstance. The SL method is shown to be asymptotically efficient, and it performs similarly to the PS and PL methods in simulation experiments. The PL method appears to have a computational advantage over the PS and SL methods.

  1. METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS

    Directory of Open Access Journals (Sweden)

    V. B. Ivanov

    2017-01-01

    Full Text Available The article considers the experience of Russian and leading foreign regulatory agencies in organisation and conduction of preclinical and clinical trials of human immunoglobulin products. The authors suggest a classification of human immunoglobulins and provide updated information on authorization of these products in Russia. The article summarizes methodological approaches, basic scientific principles and criteria relating to expert evaluation of preclinical and clinical trials of blood products. The authors further define the expert body’s requirements for data on preclinical and clinical trials of human normal immuniglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases which are submitted as part of applications for marketing authorization or marketing authorization variation. The article suggests programs of preclinical and clinical trials for human normal immunoglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases that are aligned with the Russian legislation and Eurasian Economic Union’s regulations on medicines circulation, and have been elaborated with respect to the guidelines of the European Medicines Agency.

  2. Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

    International Nuclear Information System (INIS)

    Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei; Lee, Anne W.M.; Vermorken, Jan B.; Wee, Joseph; O'Sullivan, Brian; Eisbruch, Avraham; Lin, Jin-Ching; Mai, Hai-Qiang; Zhang, Li; Guo, Ying; Lin, Ai-Hua; Sun, Ying

    2017-01-01

    Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

  3. [Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical anti-acne].

    Science.gov (United States)

    Verschoore, M; Poncet, M; Schaefer, H; Revuz, J; De Prost, Y; Guillaume, J C; Ortonne, J P; Czernielewski, J

    1991-01-01

    Acne is a frequent dermatologic disease of the teenagers. Methodology of antiacne preparations clinical trials has evolved recently, leading to better comprehension of acne treatment on acne lesions. The main rules for good clinical evaluation of acne treatments are: an objective counting of each individual lesions on a defined area (face, back), a global acne assessment, a therapy duration from 1 to 3 months or more, a skin safety evaluation for erythema, desquamation, dryness, itching, burning and oiliness with a 0 to 3 scoring system.

  4. [Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

    Science.gov (United States)

    Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

    2016-11-01

    To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles

  5. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  6. The Study of Consumer’s Post-Purchase Evaluation toward Brand Equity of Five Stars Hotels in Thailand

    OpenAIRE

    Dejsiriphun, Chonnikarn; Suviratvithayakit, Kritsana

    2011-01-01

    Date: May 30, 2011 Program: MIMA- International Marketing Course Name: Master Thesis (EFO705) Title: The Study of Consumer’s Post-Purchase Evaluation toward Brand Equity of Five Stars Hotels in Thailand Research Problem: What are the characteristics of brand equity of five star luxury hotels in Thailand and which components of brand equity are the majority concerns from customers’ evaluation? Purpose: The study aims to investigate and analyze the interrelationship of brand equity of five star...

  7. A randomised control trial on the use of topical methicillin in reducing post-operative ventriculoperitoneal shunt infection.

    Science.gov (United States)

    Theophilus, Sharon Casilda; Adnan, Johari Siregar

    2011-01-01

    A double-blind randomised control study was conducted on all patients who were admitted or referred to the Department of Neurosurgery, Sultanah Aminah Hospital, Johor Bahru, with a diagnosis of hydrocephalus where a ventriculoperitoneal shunt was indicated. The period of study was from November 2005 to May 2007, and the follow-up period was 3 months after surgery. Randomisation was carried out in the operating room prior to the procedure. The scrub nurse selected a sealed envelope, which contained the assignment of each patient to 1 of 2 treatment groups: Group 1 patients were treated with topical methicillin, and Group 2 patients were not treated with topical methicillin. Prophylactic antibiotic, cefuroxime (25 mg/kg) was given intravenously at induction. Standard sterile operative technique was followed in preparing and draping the patients. A total of 90 patients were recruited in the study, and 13 (14.4%) patients developed an infection within 3 months post-operation. Group 1 had a 8.9% risk of infection, and Group 2 had a 20% risk; however, there was no statistically significant post-operative ventriculoperitoneal shunt (VPS) infection reduction with the use of topical methicillin in VPS surgery (P = 0.230). Multivariate analysis showed that only duration of surgery had a significant influence on the incidence of post-operative VPS infection in the non-methicillin group (P = 0.02). The non-methicillin group had an 8 times greater risk of developing post-operative VPS infection than the methicillin group if surgery lasted longer than 1 hour. Topical methicillin had no significance in the reduction of post-operative VPS infection.

  8. A Randomised Control Trial on the Use of Topical Methicillin in Reducing Post-Operative Ventriculoperitoneal Shunt Infection

    Science.gov (United States)

    Theophilus, Sharon Casilda; Adnan, Johari Siregar

    2011-01-01

    Background: A double-blind randomised control study was conducted on all patients who were admitted or referred to the Department of Neurosurgery, Sultanah Aminah Hospital, Johor Bahru, with a diagnosis of hydrocephalus where a ventriculoperitoneal shunt was indicated. Methods: The period of study was from November 2005 to May 2007, and the follow-up period was 3 months after surgery. Randomisation was carried out in the operating room prior to the procedure. The scrub nurse selected a sealed envelope, which contained the assignment of each patient to 1 of 2 treatment groups: Group 1 patients were treated with topical methicillin, and Group 2 patients were not treated with topical methicillin. Prophylactic antibiotic, cefuroxime (25 mg/kg) was given intravenously at induction. Standard sterile operative technique was followed in preparing and draping the patients. Results: A total of 90 patients were recruited in the study, and 13 (14.4%) patients developed an infection within 3 months post-operation. Group 1 had a 8.9% risk of infection, and Group 2 had a 20% risk; however, there was no statistically significant post-operative ventriculoperitoneal shunt (VPS) infection reduction with the use of topical methicillin in VPS surgery (P = 0.230). Multivariate analysis showed that only duration of surgery had a significant influence on the incidence of post-operative VPS infection in the non-methicillin group (P = 0.02). The non-methicillin group had an 8 times greater risk of developing post-operative VPS infection than the methicillin group if surgery lasted longer than 1 hour. Conclusion: Topical methicillin had no significance in the reduction of post-operative VPS infection. PMID:22135571

  9. Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement

    International Nuclear Information System (INIS)

    Racadot, Severine; Mercier, Mariette; Dussart, Sophie; Dessard-Diana, Bernadette; Bensadoun, Rene-Jean; Martin, Michel; Malaurie, Emmanuelle; Favrel, Veronique; Housset, Martin; Durdux, Catherine; Journel, Catherine; Calais, Gilles; Huet, Jocelyne; Pillet, Gerard; Hennequin, Christophe; Haddad, Elias; Diana, Christian; Blaska-Jaulerry, Brigitte; Henry-Amar, Michel; Gehanno, Pierre

    2008-01-01

    Background and purpose: Post-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement. Materials and methods: The study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72 Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50 mg/m 2 administered by IV infusion twice weekly). Results: Between February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p = 0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p = 0.81). Conclusions: Twice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers

  10. A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

    Science.gov (United States)

    Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

    2016-01-01

    Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

  11. Economic evaluation of a bio-psycho-social intervention for comorbid disorders in a traumatized population in post-war Kosovo.

    Science.gov (United States)

    Chang, Wei-Lun; Andersen, Carit Jacques; Berisha, Besa Shatri; Estrup, Olena; Wang, Shr-Jie

    2018-05-08

    Post-hoc economic evaluation of a bio-psycho-social intervention in post-war Kosovo from a societal perspective. Cost-effectiveness analysis, cost-utility analysis, and partial cost-benefit analysis using data from a randomized controlled trial. Thirty-four torture/war victims with comorbid conditions enrolled in 2012-2013. Participants were randomly assigned to an "intervention" and a "waiting-list" group. Changes in mental, emotional and physical health and functional impairment were assessed before and after treatment, along with increase in labour income as a proxy for productivity gain. The cost of an extra unit of effectiveness and an additional quality-adjusted life year were calculated. The total cost per participant was €1,322 including, or €1,019 excluding, research costs. Wide variations in costs of changes in mental, emotional and physical effectiveness were demonstrated. Multidisciplinary intervention resulted in functional improvement at a cost of €10,508 per quality-adjusted life year gained. With a mean monthly income increase to €133 (18%) after intervention, the intervention cost per participant would be equal to the total increase in monthly income after 4-5 years, assuming the increased level is maintained. Socio-economic benefit associated with quality-adjusted life year gain is shown, although the cost of an additional quality-adjusted life year is above the World Health Organization cost-effectiveness threshold.

  12. Economic evaluation of a bio-psycho-social intervention for comorbid disorders in a traumatized population in post-war Kosovo

    Directory of Open Access Journals (Sweden)

    Wei-Lun Chang

    2018-02-01

    Full Text Available Objective: Post-hoc economic evaluation of a bio-psycho-social intervention in post-war Kosovo from a societal perspective. Design: Cost-effectiveness analysis, cost-utility analysis, and partial cost-benefit analysis using data from a randomized controlled trial. Patients: Thirty-four torture/war victims with comorbid conditions enrolled in 2012–2013. Methods: Participants were randomly assigned to an “intervention” and a “waiting-list” group. Changes in mental, emotional and physical health and functional impairment were assessed before and after treatment, along with increase in labour income as a proxy for productivity gain. The cost of an extra unit of effectiveness and an additional quality-adjusted life year were calculated. Results: The total cost per participant was €1,322 including, or €1,019 excluding, research costs. Wide variations in costs of changes in mental, emotional and physical effectiveness were demonstrated. Multidisciplinary intervention resulted in functional improvement at a cost of €10,508 per quality-adjusted life year gained. With a mean monthly income increase to €133 (18% after intervention, the intervention cost per participant would be equal to the total increase in monthly income after 4–5 years, assuming the increased level is maintained. Conclusion: Socio-economic benefit associated with quality-adjusted life year gain is shown, although the cost of an additional quality-adjusted life year is above the World Health Organization cost-effectiveness threshold.

  13. To evaluate and compare the effect of different Post Surface treatments on the Tensile Bond Strength between Fiber Posts and Composite Resin.

    OpenAIRE

    Shori, Deepa; Pandey, Swapnil; Kubde, Rajesh; Rathod, Yogesh; Atara, Rahul; Rathi, Shravan

    2013-01-01

    Background: Fiber posts are widely used for restoration of mutilated teeth that lack adequate coronal tooth structure to retain a core for definitive restoration, bond between the fiber post and composite material depends upon the chemical reaction between the post surface and the resin material used for building up the core. In attempt to maximize the resin bonding with fiber post, different post surface conditioning is advocated. Therefore the purpose of the study is to examine the interfac...

  14. Protocol for the effect evaluation of independent medical evaluation after six months sick leave: a randomized controlled trial of independent medical evaluation versus treatment as usual in Norway.

    Science.gov (United States)

    Husabo, Elisabeth; Monstad, Karin; Holmås, Tor Helge; Oyeflaten, Irene; Werner, Erik L; Maeland, Silje

    2017-06-14

    It has been discussed whether the relationship between a patient on sick leave and his/her general practitioner (GP) is too close, as this may hinder the GP's objective evaluation of need for sick leave. Independent medical evaluation involves an independent physician consulting the patient. This could lead to new perspectives on sick leave and how to follow-up the patient. The current study is a randomized controlled trial in a Norwegian primary care context, involving an effect evaluation, a cost/benefit analysis, and a qualitative evaluation. Independent medical evaluation will be compared to treatment as usual, i.e., the physicians' and social insurance agencies' current management of long-term sick-listed patients. Individuals aged 18-65 years, sick listed by their GP and on full or partial sick leave for the past 6 months in Hordaland county will be included. Exclusion criteria are pregnancy, cancer, dementia or an ICD-10 diagnosis. A total sample of 3800 will be randomly assigned to either independent medical evaluation or treatment as usual. Official register data will be used to measure the primary outcome; change in sickness benefits at 7, 9 and 12 months. Sick listed in other counties will serve as a second control group, if appropriate under the "common trend" assumption. The Norwegian effect evaluation of independent medical evaluation after 6 months sick leave is a large randomized controlled trial, and the first of its kind, to evaluate this type of intervention as a means of getting people back to work after long-term sickness absence. ClinicalTrials.gov NCT02524392 . Registered June 23, 2015.

  15. A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.

    Science.gov (United States)

    Cheng, Steven K; Dietrich, Mary S; Dilts, David M

    2010-11-15

    Postactivation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 were investigated for an 8-year period (n = 419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios (OR), controlling for study phase and size of expected accruals. Among the CTEP-approved oncology trials, 37.9% (n = 221) failed to attain the minimum accrual goals, with 70.8% (n = 14) of phase III trials resulting in poor accrual. A total of 16,474 patients (42.5% of accruals) accrued to those studies were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months of development were significantly more likely to achieve accrual goals (OR, 2.15; 95% confidence interval, 1.29-3.57, P = 0.003) than trials with the median development times of 12 to 18 months. Trials requiring a development time of greater than 24 months were significantly less likely to achieve accrual goals (OR, 0.40; 95% confidence interval, 0.20-0.78; P = 0.011) than trials with the median development time. A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. ©2010 AACR.

  16. Trauma-focused cognitive behaviour therapy versus treatment as usual for post traumatic stress disorder (PTSD) in young children aged 3 to 8 years: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Dalgleish, Tim; Goodall, Benjamin; Chadwick, Isobel; Werner-Seidler, Aliza; McKinnon, Anna; Morant, Nicola; Schweizer, Susanne; Panesar, Inderpal; Humphrey, Ayla; Watson, Peter; Lafortune, Louise; Smith, Patrick; Meiser-Stedman, Richard

    2015-03-25

    Following horrific or life-threatening events approximately 10 to 15% of young children develop post traumatic stress disorder (PTSD). The symptoms of this disorder are distressing - nightmares, flashbacks, anger outbursts and disturbed play. These symptoms cause major disruption to a child's functioning and, if left untreated, can persist for many years. As yet, there are no established empirically-validated treatments for PTSD in young children. Trauma-focused cognitive behaviour therapy (TF-CBT) is a psychological intervention that is effective in treating the disorder in older children (8 to 12 years), adolescents and adults. This study examines TF-CBT adapted for children aged between 3 and 8 years. This protocol describes a two-arm exploratory randomised controlled trial comparing TF-CBT to treatment as usual (TAU) in children aged 3 to 8 years with a principal diagnosis of PTSD following a single-event discrete trauma. Using a half-crossover design, 44 participants will be randomly allocated to receive the intervention or to receive TAU. Those allocated to TAU will be offered TF-CBT at the end of the 'treatment' period (approximately 12 weeks) if still indicated. The primary outcome is PTSD diagnosis according to DSM-5 criteria for children 6 years and younger at post-treatment. Secondary outcomes include effects on co-morbid diagnoses and changes in emotion and trauma symptoms at each of the follow-up points (post-treatment, 3-months, 12-months). Additionally, broader efficacy will be considered with regard to treatment feasibility, acceptability and service utilisation. The key targets of the intervention are trauma memory, the interpretation of the meaning of the event, and the management of symptoms. This is the first European trial to examine the efficacy of TF-CBT in alleviating PTSD in very young children. As well as providing much-needed data on the utility of the intervention, this exploratory trial will also allow us to gather important information

  17. Adherence to placebo and mortality in the Beta Blocker Evaluation of Survival Trial (BEST).

    Science.gov (United States)

    Pressman, Alice; Avins, Andrew L; Neuhaus, John; Ackerson, Lynn; Rudd, Peter

    2012-05-01

    Randomized controlled trials have reported lower mortality among patients who adhere to placebo compared with those who do not. We explored this phenomenon by reanalyzing data from the placebo arm of the Beta Blocker Evaluation of Survival Trial (BEST), a randomized, double-blind, placebo-controlled trial of bucindolol and mortality. Our primary aim was to measure and explain the association between adherence to placebo and total mortality among the placebo-allocated participants in the BEST trial. Secondary aims included assessment of the association between placebo adherence and cause-specific mortality. Participants with "higher placebo adherence" were defined as having taken at least 75% of their placebo study medication over the entire course of each individual's participation in the study, while those with "lower placebo adherence" took <75%. Primary outcome was in-study all-cause mortality. To account for confounding, we adjusted for all available modifiable, non-modifiable and psychosocial variables. Adherent participants had a significantly lower total mortality compared to less-adherent participants (HR=0.61, 95% Confidence Interval: 0.46-0.82). Adjusting for available confounders did not change the magnitude or significance of the estimates. When considering cause-specific mortality, CVD and pump failure showed similar associations. Analyses of the BEST trial data support a strong association between adherence to placebo study medication and total mortality. While probably not due to publication bias or simple confounding by healthy lifestyle factors, the underlying explanation for the association remains a mystery. Prospective examination of this association is necessary to better understand the underlying mechanism of this observation. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. Prevalence of and factors affecting post-obturation pain following single visit root canal treatment in Indian population: A prospective, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Syed Gufran Ali

    2012-01-01

    Full Text Available Aim: This prospective randomized clinical study (1 investigated the prevalence of post-obturation pain after single visit root canal treatment and (2 evaluated the influence of factors affecting the pain experience. Materials and Methods: One thousand three hundred and twenty eight (1328 patients were included in this study. Conventional single visit root canal treatment was carried out. The chemicomechanical preparation of root canals was done by a rotary protaper system with a combination of hand instruments. Post-operative pain was recorded by each patient by using visual analogue scale in well-defined categories at three time intervals, 12 h, 24 h, and 48 h. The data were analyzed using Fisher′s exact test. Results: The prevalence of post-obturation pain (severe within 48 h after treatment was 4% ( n = 54 but less as compared to the pain experienced after 12 h (9% and 24 h (8.6%. The factors that significantly influenced post-obturation pain experience were: Age (Fishers exact test = 46.387, P = 0.0, gender (Fishers exact test = 23.730, P = 0.0, arch (Fishers exact test = 11.710, P = 0.001, and presence of pre-operative pain (Fishers exact test = 67.456, P = 0.0. Conclusion: The presence of post-operative pain was low (4%. The important prognostic determinants of post-obturation pain were: Old age, female, mandibular teeth, and presence of pre-operative pain. The vital condition of the tooth does not affect the intensity and frequency of post-obturation pain.

  19. Understanding influences on teachers' uptake and use of behaviour management strategies within the STARS trial: process evaluation protocol for a randomised controlled trial.

    Science.gov (United States)

    Hansford, Lorraine; Sharkey, Siobhan; Edwards, Vanessa; Ukoumunne, Obioha; Byford, Sarah; Norwich, Brahm; Logan, Stuart; Ford, Tamsin

    2015-02-10

    The 'Supporting Teachers And childRen in Schools' (STARS) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management (TCM) programme as a public health intervention. TCM is a 6 day training course delivered to groups of 8-12 teachers. The STARS trial will investigate whether TCM can improve children's behaviour, attainment and wellbeing, reduce teachers' stress and improve their self-efficacy. This protocol describes the methodology of the process evaluation embedded within the main trial, which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes. The STARS trial will work with eighty teachers of children aged 4-9 years from eighty schools. Teachers will be randomised to attend the TCM course (intervention arm) or to "teach as normal" (control arm) and attend the course a year later. The process evaluation will use quantitative and qualitative approaches to assess fidelity to model, as well as explore headteachers' and teachers' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice. Four of the eight groups of teachers (n = 40) will be invited to participate in focus groups within one month of completing the TCM course, and again a year later, while 45 of the 80 headteachers will be invited to take part in telephone interviews. Standardised checklists will be completed by group leaders and each training session will be videotaped to assess fidelity to model. Teachers will also complete standardised session evaluations. This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term. The process evaluation will provide valuable insights into factors that may facilitate or impede any impact. The trial has been registered with ISCTRN

  20. Dosages of cold-water immersion post exercise on functional and clinical responses: a randomized controlled trial.

    Science.gov (United States)

    Machado, A F; Almeida, A C; Micheletti, J K; Vanderlei, F M; Tribst, M F; Netto Junior, J; Pastre, C M

    2017-11-01

    Cold-water immersion (CWI) is one of the recovery techniques commonly used by athletes for post-exercise recovery. Nevertheless, the effects of CWI using different temperatures and the dose-response relati