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Sample records for evaluation post trial

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

    PubMed Central

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

    2016-01-01

    Objective 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. Design A process evaluation using data from an RCT. Patients Forty-four severely fatigued individuals with PPS were randomized to exercise therapy (n = 22) or usual care (n = 22). Methods Participants in the exercise group were instructed to exercise 3 times weekly for 4 months on a bicycle ergometer (60–70% heart rate reserve). Results The attendance rate was high (median 89%). None of the participants trained within the target heart rate range during >75% of the designated time. Instead, participants exercised at lower intensities, though still around the anaerobic threshold (AT) most of the time. Muscle function did not improve in the exercise group. Conclusion Our results suggest that severely fatigued individuals with PPS cannot adhere to a high intensity aerobic exercise program on a cycle ergometer. Despite exercise intensities around the AT, lower extremity muscle function nor cardiorespiratory fitness improved. Improving the aerobic capacity in PPS is difficult through exercise primarily focusing on the lower extremities, and may require a more individualized approach, including the use of other large muscle groups instead. Trial Registration Netherlands National Trial Register NTR1371 PMID:27419388

  2. [Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

    PubMed

    Xie, Yanming; Wang, Yanping; Tian, Feng; Wang, Yongyan

    2011-10-01

    As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

  3. Quality evaluation of investigator-initiated trials using post-approval cancer drugs in Japan.

    PubMed

    Kondo, Shunsuke; Hosoi, Hiroko; Itahashi, Kota; Hashimoto, Jun

    2017-05-01

    Investigator-initiated trials (IIT) are important aspects of medical research and have contributed substantially to modern oncology. IIT using post-approval drugs have been conducted by domestic institutions in Japan. Data from the present study were obtained by all IIT registered clinical trials for five cancers (lung, colorectal cancer, gastric cancer, liver cancer, and breast cancer) using drugs approved from 1999 to 2009 in Japan. Kaplan-Meier method, analysis of variance (anova), and Kruskal-Wallis test were used to estimate time to enrolment completion (TTEC) and time to enrolment per patient (TTEP). Of 1222 trials eligible for analysis, 465 trials (38%) completed enrolment to the studies, and 203 trials (17%) published results. In the distribution according to trial phase, 98 (8%) were phase I, 1058 (87%) were phase I/II + II, and 66 (5%) were phase II/III + III. Accrual achievement and publication rates were higher in late-phase than in early-phase trials. Median TTEC was 1387 days (95% confidence interval [CI], 1302-1472). Median TTEP was 38.5 days (95% CI, 34.5-42.5). The median TTEC and TTEP were significantly different in each trial phase (P < 0.01), funding source (P < 0.01), and publication status (median TTEC published trials versus unpublished trial; 720 days vs 1672 days, median TTEP; 16 days vs 55.8 days; P < 0.001). Many IIT using approved cancer drugs have been conducted; however, the quality of the clinical trials was low in terms of accrual achievement, publication rate, and time to publication of trial results. © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

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

    DTIC Science & Technology

    2010-12-10

    all organizational levels, impacting military justice in both the Navy and Marine Corps. The failures resulted in inadequate institutional vigilance to...contribute to the continuing time delay and quality problems in post-trial processing. Another factor adversely impacting military justice competence is... impact . The reduced time in grade narrows a junior officer’s experience base at the time he/she would normally assume a mid-level leadership

  5. Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India

    PubMed Central

    Liu, Hueiming; Lindley, Richard; Alim, Mohammed; Felix, Cynthia; Gandhi, Dorcas B C; Verma, Shweta J; Tugnawat, Deepak Kumar; Syrigapu, Anuradha; Ramamurthy, Ramaprabhu Krishnappa; Pandian, Jeyaraj D; Walker, Marion; Forster, Anne; Anderson, Craig S; Langhorne, Peter; Murthy, Gudlavalleti Venkata Satyanarayana; Shamanna, Bindiganavale Ramaswamy; Hackett, Maree L; Maulik, Pallab K; Harvey, Lisa A; Jan, Stephen

    2016-01-01

    Introduction We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting. Methods and analysis The realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation. Ethics and dissemination The process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation. Trial registration number CTRI/2013

  6. 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

    PubMed Central

    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/m2 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/m2 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. PMID:25768401

  7. 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.

    PubMed

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

    2015-03-13

    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.

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

    PubMed

    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.

  9. Evaluating the role of Magnetic Resonance Imaging post Neoadjuvant Therapy for Breast Cancer in the NEONAB trial.

    PubMed

    Murphy, Caitlin; Mukaro, Violet; Tobler, Robert; Asher, Rebecca; Gibbs, Emma; West, Linda; Giuffre, Bruno; Baron-Hay, Sally; Khasraw, Mustafa

    2017-09-04

    Magnetic Resonance Imaging (MRI) accuracy after neoadjuvant systemic therapy (NST) for breast cancer varies according to hormone receptor (HR), human epidermal growth factor receptor type-2 (HER2) subtype and Ki67 proliferation index. Whether MRI accuracy varies by genomic signatures is unknown. We examined accuracy of MRI in the NEONAB trial (Clinicaltrials.gov #: NCT01830244). Patients with stage II-III breast cancer received sequential epirubicin, cyclophosphamide and nab-paclitaxel and trastuzumab if HER2+. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated to assess utility of preoperative MRI to predict pathological complete response (pCR). Bland-Altman plots were used to assess agreement between MRI and pathological assessment of residual disease. MRI correctly predicted pCR in 64.1% of the cohort. Sensitivity and specificity were 52% and 78%, PPV 73% and NPV 58%. MRI predicted pCR most accurately in HER2-positive patients; sensitivity 58%, specificity 100%, PPV 100% and NPV 38%. MRI had higher PPV and NPV in tumours with Ki67 ≥ 15% than tumours with Ki67 < 15%, 75% versus 50% and 57.5% versus 50% respectively. In this study, MRI underestimated residual tumour size by 1.65mm (limits of agreement: 43.07mm-39.77mm). MRI appears more accurate for predicting pCR in HER2+ disease than other subtypes and in cancers with Ki67 ≥15% compared to those with Ki67 <15%. Accuracy of MRI in our HR+, RS ≥ 25 cohort is comparable to previous reports of unselected HR+ disease. MRI post-NST should be interpreted in conjunction with HER2 status and Ki67 index of the primary. This article is protected by copyright. All rights reserved.

  10. Post combustion trials at Dofasco's KOBM furnace

    SciTech Connect

    Farrand, B.L.; Wood, J.E.; Goetz, F.J.

    1992-01-01

    Post combustion trials were conducted at Dofasco's 300 tonne KOBM furnace as part of the AISI Direct Steelmaking Program. The purpose of the project work was to measure the post combustion ratio (PCR) and heat transfer efficiency (HTE) of the post combustion reaction in a full size steelmaking vessel. A method of calculating PCR and HTE using off gas analysis and gas temperature was developed. The PCR and HTE were determined under normal operating conditions. Trials assessed the effect of lance height, vessel volume, foaming slag and pellet additions on PCR and HTE.

  11. [Evaluation of clinical trials].

    PubMed

    Ural, Dilek

    2010-03-01

    Women are under-represented in landmark clinical trials that form the basis of evidence based management of cardiovascular diseases. Differences among male and female patients emerged in effectiveness and safety of therapeutics in some diseases. Especially in dyslipidemia, ischemic heart diseases and heart failure, trials in which women are better represented and guidelines that evaluate findings in women more detailed are needed. This article evaluates differences among men and women in some landmark trials that are used among main references in management guidelines.

  12. A Clinically Integrated Post-Graduate Training Programme in Evidence-Based Medicine versus ‘No Intervention’ for Improving Disability Evaluations: A Cluster Randomised Clinical Trial

    PubMed Central

    Kok, Rob; Hoving, Jan L.; Smits, Paul B. A.; Ketelaar, Sarah M.; van Dijk, Frank J. H.; Verbeek, Jos H.

    2013-01-01

    Background Although several studies have shown that teaching EBM is effective in improving knowledge, at present, there is no convincing evidence that teaching EBM also changes professional behaviour in practice. Therefore, the primary aim of this study was to evaluate the effectiveness of a clinically integrated post-graduate training programme in EBM on evidence-based disability evaluation. Methods and Findings In a cluster randomised controlled trial, fifty-four case-based learning groups consisting of 132 physicians and 1680 patients were randomly assigned to the intervention or control groups. A clinically integrated, post-graduate, 5-day training programme in evidence-based medicine, consisting of (home) assignments, peer teaching, interactive training in searching databases, lectures and brainstorming sessions was provided to the intervention group. The control group received no training. The primary outcome was evidence-based disability evaluation, as indicated by the frequency in use of evidence of sufficient quality in disability evaluation reports. There are no general EBM behaviour outcome measures available. Therefore, we followed general guidelines for constructing performance indicators and defined an a priori cut-off for determination of sufficient quality as recommended for evaluating EB training. Physicians trained in EBM performed more evidence-based disability evaluations compared to physicians in the control group (difference in absolute proportion 9.7%, 95% CI 3.5 to 15.9). The primary outcome differences between groups remained significant after both cluster-adjusted analysis and additional sensitivity analyses accounting for subjects lost to follow-up. Conclusions A EBM programme successfully improved the use of evidence in a non-hospital based medical specialty. Our findings support the general recommendations to use multiple educational methods to change physician behaviour. In addition, it appeared important that the professional context

  13. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines.

    PubMed

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-03-24

    Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes.

  14. The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines

    PubMed Central

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-01-01

    Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes. PMID:25444788

  15. Risk-based evaluation of efficacy of rolofylline in patients hospitalized with acute heart failure - Post-hoc analysis of the PROTECT trial.

    PubMed

    Demissei, Biniyam G; Postmus, Douwe; Liu, Licette C Y; Cleland, John G; O'Connor, Christopher M; Metra, Marco; Ponikowski, Piotr; Teerlink, John R; Cotter, Gad; Davison, Beth A; Edwards, Christopher; Givertz, Michael M; Bloomfield, Daniel M; Dittrich, Howard C; Voors, Adriaan A; Hillege, Hans L

    2016-11-15

    The selective adenosine A1 receptor antagonist rolofylline showed a neutral overall result on clinical outcomes in the PROTECT trial. However, we hypothesized that response to rolofylline treatment could be influenced by underlying clinical risk. We performed a post-hoc analysis of the PROTECT trial - a large, double-blind, randomized, placebo-controlled trial that enrolled 2033 patients. Baseline risk of 180-day all-cause mortality was estimated using a previously published 8-item model. Evaluation of efficacy of rolofylline across subpopulations defined based on estimated risk of mortality was performed using subpopulation treatment effect pattern plot (STEPP) analysis. Findings were validated in an independent cohort of acute heart failure patients. Median estimated risk of mortality was 13.0%, IQR [8.0%-23.0%] and was comparable between the rolofylline and placebo arms. In low to intermediate risk subgroups of patients, rolofylline was associated with a higher rate of 180-day all-cause mortality (11.9% in the rolofylline versus 8.4% in the placebo arms, p=0.050). In the high risk subgroup of patients, particularly those with estimated risk of mortality between 20% and 30%, 180-day all-cause mortality rate was markedly lower in the rolofylline arm (18.4% in the rolofylline versus 34.0% in the placebo arms, p=0.003). The trend towards potential harm with rolofylline treatment in the low to intermediate risk subpopulations and significant benefit in high risk patients was also observed in the validation cohort. Our findings suggest that selective adenosine A1 receptor antagonism could be harmful in low risk acute heart failure patients, while it might significantly benefit higher risk patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. 'Plain lignocaine' vs 'Lignocaine with vasoconstrictor'-Comparative evaluation of pain during administration and post-extraction wound healing by a double blinded randomized controlled clinical trial.

    PubMed

    Panneerselvam, Elavenil; Balasubramanian, Sasikala; Raja V B, Krishnakumar; Kannan, Ravi; Rajaram, Krishnaraj; Rajendra Sharma, Aditi

    2016-07-01

    The aim of this double blinded randomized controlled clinical trial was to evaluate the efficacy of two local anaesthetic solutions, 'Plain lignocaine' and 'Lignocaine with vasoconstrictor', on pain during administration and post-extraction wound healing in patients undergoing therapeutic extractions. Fifty patients indicated for therapeutic extraction of upper and lower premolars for orthodontic purpose were recruited for the study. Using a split-mouth study design, anaesthesia was achieved using lignocaine with adrenaline on the control side and plain lignocaine on the study side. Pain perception was measured by modified visual analogue scale and wound healing was assessed by Landry's Wound Healing Index. Sample allocation was done by simple randomization. The outcome parameters compared were (1) pain during administration of LA and (2) post-operative healing after extraction. Data analysis involved Chi-square test to compare proportions between treatment groups and independent sample t-test to compare mean values between treatment groups. SPSS version 22.0 was used to analyse the data. The study group demonstrated a statistically significant wound healing on day1 and day 3 between the study and control group with p < 0.001. In the control group 68% had severe pain, whereas only 2% had severe pain in the study group. The proportions between the two groups were statistically significant (p < 0.001). The patients who received Plain Lignocaine perceived less pain during injection of local anaesthetic solution when compared to patients who received lignocaine with vasoconstrictor. The early post-operative wound healing was better in patients anaesthetized by Plain Lignocaine.

  17. 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.

    PubMed

    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

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

    PubMed Central

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

    2016-01-01

    Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of death across the world and will become increasingly common with an aging population. Pulmonary rehabilitation (PR) is an evidence-based, nonpharmacological intervention for individuals with COPD, targeting the secondary impairments of the disease. Although the benefits of participation in PR are well established, improvements in exercise tolerance and health status typically deteriorate following discharge. Challenges with long-term adherence to recommended exercise regimens are thought to explain much of this decline. Therefore, we developed a community-based exercise maintenance program for patients with COPD following discharge from PR. Objectives 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. Methods 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

  19. Evaluation of the effectiveness of manual chest physiotherapy techniques on quality of life at six months post exacerbation of COPD (MATREX): a randomised controlled equivalence trial

    PubMed Central

    2012-01-01

    Background Manual chest physiotherapy (MCP) techniques involving chest percussion, vibration, and shaking have long been used in the treatment of respiratory conditions. However, methodological limitations in existing research have led to a state of clinical equipoise with respect to this treatment. Thus, for patients hospitalised with an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), clinical preference tends to dictate whether MCP is given to assist with sputum clearance. We standardised the delivery of MCP and assessed its effectiveness on disease-specific quality of life. Methods In this randomised, controlled trial powered for equivalence, 526 patients hospitalised with acute COPD exacerbation were enrolled from four centres in the UK. Patients were allocated to receive MCP plus advice on airway clearance or advice on chest clearance alone. The primary outcome was a COPD specific quality of life measure, the Saint Georges Respiratory Questionnaire (SGRQ) at six months post randomisation. Analyses were by intention to treat (ITT). This study was registered, ISRCTN13825248. Results All patients were included in the analyses, of which 372 (71%) provided evaluable data for the primary outcome. An effect size of 0·3 standard deviations in SGRQ score was specified as the threshold for superiority. The ITT analyses showed no significant difference in SGRQ for patients who did, or did not receive MCP (95% CI −0·14 to 0·19). Conclusions These data do not lend support to the routine use of MCP in the management of acute exacerbation of COPD. However, this does not mean that MCP is of no therapeutic value to COPD patients in specific circumstances. PMID:22748085

  20. Post-gemcitabine therapy for patients with advanced pancreatic cancer - A comparative review of randomized trials evaluating oxaliplatin- and/or irinotecan-containing regimens.

    PubMed

    Vogel, Arndt; Ciardiello, Fortunato; Hubner, Richard A; Blanc, Jean-Frédéric; Carrato, Alfredo; Yang, Yoojung; Patel, Dipen A; Ektare, Varun; de Jong, Floris A; Gill, Sharlene

    2016-11-01

    A systematic review and critical evaluation of randomized trial evidence for oxaliplatin- or irinotecan-containing regimens in patients with advanced pancreatic cancer previously treated with gemcitabine has not yet been published. We conducted a comparative systematic review of randomized trials evaluating oxaliplatin- or irinotecan-based therapies in patients with advanced pancreatic cancer previously treated with gemcitabine to assess trial similarity and the feasibility of performing an indirect treatment comparison (ITC). Studies were identified through PubMed and key oncology conference abstracts. The following trials met our criteria: NAPOLI-1 (nanoliposomal irinotecan [nal-IRI] or nal-IRI+5-fluorouracil [5-FU]/leucovorin [LV] vs 5-FU/LV), CONKO-003 (oxaliplatin+5-FU/LV [OFF] vs 5-FU/LV), PANCREOX (oxaliplatin+5-FU/LV [mFOLFOX6] vs 5-FU/LV), and Yoo et al. (2009) (irinotecan+5-FU/LV [mFOLFIRI3] vs mFOLFOX). Fundamental differences were identified in study design (i.e., number of study sites, number of countries), patient (i.e., locally advanced vs metastatic disease, stratification variables, prior and subsequent treatments) and treatment (i.e., regimens, dose intensity) characteristics, and primary and secondary outcomes (i.e., primary vs secondary outcomes, overall survival [OS], progression-free survival [PFS]) among the 4 included trials. Our comparative review demonstrated significant dissimilarity across trials, which precluded conducting an ITC. In the absence of head-to-head nal-IRI- and/or oxaliplatin-based therapy trials, clinicians are advised to interpret these studies separately within the context of their individual patient population.

  1. Post Occupancy Evaluation in Scotland

    ERIC Educational Resources Information Center

    Watson, Chris; Thomson, Keith

    2004-01-01

    The Scottish Executive, the devolved government for Scotland, is engaging with stakeholders to achieve excellence in the school estate through Post Occupancy Evaluation (POE). Design of the school environment has a direct impact on teaching and learning, activities which can be supported or frustrated by many building elements. Through a…

  2. 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

    PubMed Central

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

    2014-01-01

    Introduction 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. Methods 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. Results 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. Conclusion 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

  3. The relative efficacy of bona fide psychotherapies for post-traumatic stress disorder: a meta-analytical evaluation of randomized controlled trials.

    PubMed

    Tran, Ulrich S; Gregor, Bettina

    2016-07-26

    In the treatment of PTSD, meta-analyses suggest comparable efficacy of cognitive behavioural therapies and various trauma focused treatments, but results for other treatments are inconsistent. One meta-analysis found no differences for bona fide therapies, but was critizised for overgeneralization and a biased study sample and relied on an omnibus test of overall effect size heterogeneity that is not widely used. We present an updated meta-analysis on bona fide psychotherapies for PTSD, contrasting an improved application of the omnibus test of overall effect size heterogeneity with conventional random-effects meta-analyses of specified treatment types against all others. Twenty-two studies were eligible, reporting 24 head-to-head comparisons in randomized controlled trials of 1694 patients. Head-to-head comparison between trauma focused and non-trauma focused treatments revealed a small relative advantage for trauma focused treatments at post-treatment (Hedges' g = 0.14) and at two follow-ups (g = 0.17, g = 0.23) regarding PTSD symptom severity. Controlling and adjusting for influential studies and publication bias, prolonged exposure and exposure therapies (g = 0.19) were slightly more efficacious than other therapies regarding PTSD symptom severity at post-treatment; prolonged exposure had also higher recovery rates (RR = 1.26). Present-centered therapies were slightly less efficacious regarding symptom severity at post-treatment (g = -0.20) and at follow-up (g = -0.17), but equally efficacious as available comparison treatments with regards to secondary outcomes. The improved omnibus test confirmed overall effect size heterogeneity. Trauma focused treatments, prolonged exposure and exposure therapies were slightly more efficacious than other therapies in the treatment of PTSD. However, treatment differences were at most small and far below proposed thresholds of clinically meaningful differences. Previous null findings may have

  4. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals.

    PubMed

    Riveros, Carolina; Dechartres, Agnes; Perrodeau, Elodie; Haneef, Romana; Boutron, Isabelle; Ravaud, Philippe

    2013-12-01

    The US Food and Drug Administration Amendments Act requires results from clinical trials of Food and Drug Administration-approved drugs to be posted at ClinicalTrials.gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals. We searched ClinicalTrials.gov on March 27, 2012, for randomized controlled trials of drugs with posted results. For a random sample of these trials, we searched PubMed for corresponding publications. Data were extracted independently from ClinicalTrials.gov and from the published articles for trials with results both posted and published. We assessed the time to first public posting or publishing of results and compared the completeness of results posted at ClinicalTrials.gov versus published in journal articles. Completeness was defined as the reporting of all key elements, according to three experts, for the flow of participants, efficacy results, adverse events, and serious adverse events (e.g., for adverse events, reporting of the number of adverse events per arm, without restriction to statistically significant differences between arms for all randomized patients or for those who received at least one treatment dose). From the 600 trials with results posted at ClinicalTrials.gov, we randomly sampled 50% (n = 297) had no corresponding published article. For trials with both posted and published results (n = 202), the median time between primary completion date and first results publicly posted was 19 mo (first quartile = 14, third quartile = 30 mo), and the median time between primary completion date and journal publication was 21 mo (first quartile = 14, third quartile = 28 mo). Reporting was significantly more complete at ClinicalTrials.gov than in the published article for the flow of participants (64% versus 48% of trials, p<0.001), efficacy results (79% versus 69%, p = 0.02), adverse events (73% versus 45

  5. Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

    PubMed Central

    Riveros, Carolina; Dechartres, Agnes; Perrodeau, Elodie; Haneef, Romana; Boutron, Isabelle; Ravaud, Philippe

    2013-01-01

    Background The US Food and Drug Administration Amendments Act requires results from clinical trials of Food and Drug Administration–approved drugs to be posted at ClinicalTrials.gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals. Methods and Findings We searched ClinicalTrials.gov on March 27, 2012, for randomized controlled trials of drugs with posted results. For a random sample of these trials, we searched PubMed for corresponding publications. Data were extracted independently from ClinicalTrials.gov and from the published articles for trials with results both posted and published. We assessed the time to first public posting or publishing of results and compared the completeness of results posted at ClinicalTrials.gov versus published in journal articles. Completeness was defined as the reporting of all key elements, according to three experts, for the flow of participants, efficacy results, adverse events, and serious adverse events (e.g., for adverse events, reporting of the number of adverse events per arm, without restriction to statistically significant differences between arms for all randomized patients or for those who received at least one treatment dose). From the 600 trials with results posted at ClinicalTrials.gov, we randomly sampled 50% (n = 297) had no corresponding published article. For trials with both posted and published results (n = 202), the median time between primary completion date and first results publicly posted was 19 mo (first quartile = 14, third quartile = 30 mo), and the median time between primary completion date and journal publication was 21 mo (first quartile = 14, third quartile = 28 mo). Reporting was significantly more complete at ClinicalTrials.gov than in the published article for the flow of participants (64% versus 48% of trials, p<0.001), efficacy results (79% versus 69%, p = 0

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

    PubMed

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

    2013-10-01

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

  7. Post combustion trials at Dofasco`s KOBM furnace

    SciTech Connect

    Farrand, B.L.; Wood, J.E.; Goetz, F.J.

    1992-12-31

    Post combustion trials were conducted at Dofasco`s 300 tonne KOBM furnace as part of the AISI Direct Steelmaking Program. The purpose of the project work was to measure the post combustion ratio (PCR) and heat transfer efficiency (HTE) of the post combustion reaction in a full size steelmaking vessel. A method of calculating PCR and HTE using off gas analysis and gas temperature was developed. The PCR and HTE were determined under normal operating conditions. Trials assessed the effect of lance height, vessel volume, foaming slag and pellet additions on PCR and HTE.

  8. A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches

    DTIC Science & Technology

    2010-05-01

    trial is being conducted to evaluate the effectiveness of propranolol , topiramate, and amitriptyline as treatments for chronic post-traumatic headaches...effectiveness of propranolol , amitriptyline, and topiramate as treatments for chronic PTHAs. We are conducting a single-center, prospective, randomized...double-blind, placebo-controlled, multi-arm trial to evaluate propranolol , amitriptyline, and topiramate for treatment of chronic PTHAs. A total of

  9. Evaluation Using Sequential Trials Methods.

    ERIC Educational Resources Information Center

    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)

  10. Phase 3 trial evaluating the immunogenicity and safety of a three-dose BioThrax® regimen for post-exposure prophylaxis in healthy adults.

    PubMed

    Hopkins, Robert J; Howard, Cris; Hunter-Stitt, Ericka; Kaptur, Paulina E; Pleune, Brett; Muse, Derek; Sheldon, Eric; Davis, Matthew; Strout, Cynthia; Vert-Wong, Katya

    2014-04-17

    This study was conducted to support licensure of a post-exposure prophylaxis indication for BioThrax(®) (anthrax vaccine adsorbed) concurrent with antimicrobials for individuals exposed to aerosolized anthrax spores. The immunogenicity and safety of a three-dose regimen (0, 2, and 4 weeks) of BioThrax administered subcutaneously (SC) were evaluated in 200 healthy adults 18-65 years of age. Toxin-neutralizing antibody (TNA) was expressed as 50% neutralization factor (NF50) at predetermined time points through Day 100. Safety was assessed by physical examinations, vital signs, solicited local and systemic reactions using web-enabled subject diaries, in-clinic solicited reactions, and unsolicited adverse events (AEs). The prospectively defined success criteria for the primary and secondary endpoints were met. This required the lower bound of the 95% confidence interval (CI) for the proportion of subjects with a TNA NF50 value to be greater than 40% at Day 63 (primary), Day 70 (secondary) and Days 63-100 (secondary). At Day 63, 71% of subjects achieved a TNA NF50 threshold value ≥ 0.56, with a lower bound of the 95% CI ≥ 40% (64%). The percentage of subjects achieving a TNA NF50 threshold value ≥ 0.56 at Day 70 was 58% (95% CI: 50%, 65%), and the mean value on Days 63-100 (inclusive) was 53% (95% CI: 41%, 55%). The threshold TNA NF50 value of 0.56 was developed from previous rabbit challenge and human immunogenicity studies. No related serious AEs occurred during the study, and no subjects withdrew from the study because of an AE. Tenderness and pain at the injection site were recorded most often in subject diaries following vaccination. BioThrax, administered as three SC doses at 0, 2, and 4 weeks, was well tolerated. The prospectively defined success criteria for TNA levels on Days 63, 70, and 63-100 were achieved. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Mind the gap: An empirical study of post-trial access in HIV biomedical prevention trials.

    PubMed

    Haire, Bridget; Jordens, Christopher

    2015-08-01

    The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. © 2013 John Wiley & Sons Ltd.

  12. A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial

    PubMed Central

    Jacob, Shevin T.; Baeten, Jared M.; Hughes, James P.; Peinado, Jesús; Wang, Jing; Sanchez, Jorge; Reid, Stewart E.; Delany-Moretlwe, Sinead; Cowan, Frances; Fuchs, Jonathan; Koblin, Beryl; Griffith, Sam; Wald, Anna; Celum, Connie

    2010-01-01

    High adherence and maintenance of blinding are critical for placebo-controlled efficacy trials of HIV-1 biomedical prevention strategies. We assessed adherence to study drug and factors affecting adherence, including perceived randomization group, in a post-trial questionnaire of participants who completed HPTN 039, a randomized, placebo-controlled trial of HSV-2 suppression with twice-daily acyclovir to reduce HIV-1 acquisition. Of the 3172 trial participants, 2003 (63%) completed the post-trial questionnaire. Of these 2003, 72% reported missing a dose of study drug less than twice a week. Study drug adherence was not compromised by perceived randomization or genital ulcer symptoms during the study. Alcohol use was cited as an adherence barrier in some populations. Assessment of study drug adherence during and at the end of trials can evaluate perceptions of randomization and adherence by randomization arm, help to better understand barriers to and motivations for adherence, and develop interventions to increase adherence for future trials. PMID:21104007

  13. In vitro evaluation of glass fiber post

    PubMed Central

    Sharma, Navneet; Singh, Harpal

    2012-01-01

    Statement of problem: Techniques and recommendations for the restoration of endodontically treated teeth have changed from the use of custom cast metal post and core system to glass fiber-reinforced (GFRC) post and composite core system. Has this latest prefabricated glass fiber reinforced post and composite core system increased the fracture resistance of teeth and reduced the incidence of unrestorable root fractures. Purpose: The purpose of this study was to evaluate the incidence of root fracture and mode of failure of endodontically treated teeth restored with two different post and core systems. Material and Methods: Forty maxillary central incisors were randomly divided into two groups. (n=20). All teeth received endodontic treatment. First group was restored with custom cast post and core system. Second group was restored with glass fiber post and composite core system. In Both the groups posts were cemented with adhesive resin cement. Compressive load was applied at an angle of 130 to the long axis of teeth at a cross head speed of 1 mm/min until fracture occurred. Data were analyzed with student “t” test P<.001. Results: The mean value for fracture resistance was (331.4025) N in Group -I Custom cast Ni-Cr post and core and (237.0625) N in Group -II Glass fiber reinforced post and composite core system. Students “t” test shows the significant difference in fracture resistance of two groups. Conclusion: This study showed that the incidence of root fracture was significantly higher in custom cast Ni-Cr post and core system than glass fiber post and composite core system. A more favourable mode of failure was observed in teeth restored with Group II glass fiber post system. Key words:Post-and-core technique, glass fiber post, cast post and-core system, fracture resistance, endodontically treated teeth. PMID:24558556

  14. Evaluation of blood pressure reduction response and responder characteristics to fixed-dose combination treatment of amlodipine and losartan: a post hoc analysis of pooled clinical trials.

    PubMed

    Unniachan, Sreevalsa; Wu, David; Rajagopalan, Srinivasan; Hanson, Mary E; Fujita, Kenji P

    2014-09-01

    Data from four clinical trials compared reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) among patients treated with amlodipine/losartan 5/50 mg vs 5/100 mg and amlodipine/losartan 5/50 mg vs amlodipine 5 mg and 10 mg. Response rate was assessed as reduction in SBP or DBP (>20/10 mm Hg) and proportion of patients achieving SBP <140 mm Hg or DBP <90 mm Hg. Patients were grouped into quartiles based on baseline SBP and DBP. Mean SBP and DBP were reduced in amlodipine/losartan 5/50 mg (n=182) and amlodipine/losartan 5/100 mg (n=95) users across all baseline quartiles. Patients using amlodipine/losartan 5/50 mg had significantly greater SBP and DBP reductions vs amlodipine 5 mg (P=.001 and P=.02, respectively). Amlodipine/losartan 5/50 mg users had significantly greater SBP reduction vs amlodipine 10 mg (SBP P=.02; DBP P=not significant). The odds of responding to therapy were significantly greater with amlodipine/losartan 5/50 mg vs amlodipine 5 mg (odds ratio, 5.33; 95% confidence interval, 1.42-25.5) and were similar vs amlodipine 10 mg (odds ratio, 0.67; 95% confidence interval, 0.017-9.51). These results support the use of combination therapy early in the treatment of hypertension.

  15. 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

    PubMed Central

    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 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 mothers; therefore

  16. Cognitive-behaviour therapy for post-traumatic stress in schizophrenia. A randomized controlled trial.

    PubMed

    Steel, C; Hardy, A; Smith, B; Wykes, T; Rose, S; Enright, S; Hardcastle, M; Landau, S; Baksh, M F; Gottlieb, J D; Rose, D; Mueser, K T

    2017-01-01

    There is limited evidence for effective interventions in the treatment of post-traumatic stress symptoms within individuals diagnosed with schizophrenia. Clinicians have concerns about using exposure treatments with this patient group. The current trial was designed to evaluate a 16-session cognitive restructuring programme, without direct exposure, for the treatment of post-traumatic stress symptoms specifically within individuals diagnosed with schizophrenia. A multicentre randomized controlled single-blinded trial with assessments at 0 months, 6 months (post-treatment) and 12 months (follow-up) was conducted. A total of 61 participants diagnosed with schizophrenia and exhibiting post-traumatic stress symptoms were recruited. Those randomized to treatment were offered up to 16 sessions of cognitive-behaviour therapy (CBT, including psychoeducation, breathing training and cognitive restructuring) over a 6-month period, with the control group offered routine clinical services. The main outcome was blind rating of post-traumatic stress symptoms using the Clinician Administered PTSD Scale for Schizophrenia. Secondary outcomes were psychotic symptoms as measured by the Positive and Negative Symptom Scale and the Psychotic Symptom Rating Scale. Both the treatment and control groups experienced a significant decrease in post-traumatic stress symptoms over time but there was no effect of the addition of CBT on either the primary or secondary outcomes. The current trial did not demonstrate any effect in favour of CBT. Cognitive restructuring programmes may require further adaptation to promote emotional processing of traumatic memories within people diagnosed with a psychotic disorder.

  17. 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.

    PubMed

    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

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

    PubMed

    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.

  19. Rosuvastatin for primary prevention in patients with European systematic coronary risk evaluation risk ≥5% or Framingham risk >20%: post hoc analyses of the JUPITER trial requested by European health authorities

    PubMed Central

    Koenig, Wolfgang; Ridker, Paul M

    2011-01-01

    Aims On the basis of the JUPITER trial, European health authorities recently approved the use of rosuvastatin to reduce first major cardiovascular events among ‘high' global risk primary prevention patients defined either by Framingham risk score >20% or European systematic coronary risk evaluation (SCORE) ≥5%. However, as these are post hoc analyses, data describing these subgroups have not previously been available to the clinical community. Methods and results We randomized 17 802 apparently healthy men aged ≥50 and women ≥60 with low-density lipoprotein cholesterol (LDL-C) <3.4 mmol/L, who were at an increased vascular risk due to elevated levels of C-reactive protein measured with a high-sensitivity (hs) assay to rosuvastatin 20 mg daily or placebo. Patients with high global cardiovascular risk at baseline were identified by 10-year Framingham risk score >20% or SCORE risk ≥5%. During 1.8-year median follow-up (maximum 5 years) of patients with Framingham risk >20%, the rate of myocardial infarction/stroke/cardiovascular death was 9.4 and 18.2 per 1000 person-years in rosuvastatin and placebo-allocated patients, respectively [hazard ratio (HR): 0.50, 95% confidence interval (CI): 0.27–0.93, P = 0.028]. Among patients with SCORE risk ≥5%, the corresponding rates were 6.9 and 12.0 using a model extrapolating risk for age ≥65 years (HR: 0.57, 95% CI: 0.43–0.78, P = 0.0003) and rates were 5.9 and 12.7 when risk for age was capped at 65 years (HR: 0.47, 95% CI: 0.32–0.68, P < 0.0001). Conclusion In primary prevention patients with elevated hs C-reactive protein who have high global cardiovascular risk (10-year Framingham risk score >20% or SCORE risk ≥5%), but LDL-C levels not requiring pharmacologic treatment, rosuvastatin 20 mg significantly reduced major cardiovascular events. ClinicalTrial.gov Identifier: NCT00239681 PMID:20971747

  20. Effect of baseline exercise capacity on outcomes in patients with stable coronary heart disease (a post hoc analysis of the clinical outcomes utilizing revascularization and aggressive drug evaluation trial).

    PubMed

    Padala, Santosh K; Sidhu, Mandeep S; Hartigan, Pamela M; Maron, David J; Teo, Koon K; Spertus, John A; Mancini, G B John; Sedlis, Steven P; Chaitman, Bernard R; Heller, Gary V; Weintraub, William S; Boden, William E

    2015-11-15

    The impact of baseline exercise capacity on clinical outcomes in patients with stable ischemic heart disease randomized to an initial strategy of optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI) in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial has not been studied. A post hoc analysis was performed in 1,052 patients of COURAGE (PCI + OMT: n = 527, OMT: n = 525) who underwent exercise treadmill testing at baseline. Patients were categorized into 2 exercise capacity groups based on metabolic equivalents (METs) achieved during baseline exercise treadmill testing (<7 METs: n = 464, ≥7 METs: n = 588) and were followed for a median of 4.6 years. The primary composite end point of death or myocardial infarction was similar in the PCI + OMT group and the OMT group for patients with exercise capacity <7 METs (19.1% vs 16.1%, p = 0.31) and ≥7 METs (13.3% vs 10.3%, p = 0.27). After adjusting for baseline covariates, the hazard ratio (99% confidence interval) for the primary end point for the PCI + OMT group versus the OMT group was 1.42 (0.90 to 2.23, p = 0.05) and for the exercise capacity subgroups of ≥7 METs and <7 METs was 0.75 (0.46 to 1.22, p = 0.13). There was no statistically significant interaction between the original treatment arm allocation (PCI + OMT vs OMT) and baseline exercise capacity. In conclusion, there was no difference in the long-term clinical outcomes in patients with exercise capacity <7 METs compared with ≥7 METs, irrespective of whether they were assigned to initial PCI. Patients with exercise capacity <7 METs did not derive a proportionately greater clinical benefit from PCI + OMT compared with those patients who received OMT alone. Published by Elsevier Inc.

  1. Post Hoc Analysis of Data from Two Clinical Trials Evaluating the Minimal Clinically Important Change in International Restless Legs Syndrome Sum Score in Patients with Restless Legs Syndrome (Willis-Ekbom Disease)

    PubMed Central

    Ondo, William G.; Grieger, Frank; Moran, Kimberly; Kohnen, Ralf; Roth, Thomas

    2016-01-01

    Study Objectives: Determine the minimal clinically important change (MCIC), a measure determining the minimum change in scale score perceived as clinically beneficial, for the international restless legs syndrome (IRLS) and restless legs syndrome 6-item questionnaire (RLS-6) in patients with moderate to severe restless legs syndrome (RLS/Willis-Ekbom disease) treated with the rotigotine transdermal system. Methods: This post hoc analysis analyzed data from two 6-mo randomized, double-blind, placebo-controlled studies (SP790 [NCT00136045]; SP792 [NCT00135993]) individually and as a pooled analysis in rotigotine-treated patients, with baseline and end of maintenance IRLS and Clinical Global Impressions of change (CGI Item 2) scores available for analysis. An anchor-based approach and receiver operating characteristic (ROC) curves were used to determine the MCIC for the IRLS and RLS-6. We specifically compared “much improved vs minimally improved,” “much improved/very much improved vs minimally improved or worse,” and “minimally improved or better vs no change or worse” on the CGI-2 using the full analysis set (data as observed). Results: The MCIC IRLS cut-off scores for SP790 and SP792 were similar. Using the pooled SP790+SP792 analysis, the MCIC total IRLS cut-off score (sensitivity, specificity) for “much improved vs minimally improved” was −9 (0.69, 0.66), for “much improved/very much improved vs minimally improved or worse” was −11 (0.81, 0.84), and for “minimally improved or better vs no change or worse” was −9 (0.79, 0.88). MCIC ROC cut-offs were also calculated for each RLS-6 item. Conclusions: In patients with RLS, the MCIC values derived in the current analysis provide a basis for defining meaningful clinical improvement based on changes in the IRLS and RLS-6 following treatment with rotigotine. Citation: Ondo WG, Grieger F, Moran K, Kohnen R, Roth T. Post hoc analysis of data from two clinical trials evaluating the minimal

  2. Low levels of high-density lipoprotein cholesterol and increased risk of cardiovascular events in stable ischemic heart disease patients: A post-hoc analysis from the COURAGE Trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation).

    PubMed

    Acharjee, Subroto; Boden, William E; Hartigan, Pamela M; Teo, Koon K; Maron, David J; Sedlis, Steven P; Kostuk, William; Spertus, John A; Dada, Marcin; Chaitman, Bernard R; Mancini, G B John; Weintraub, William S

    2013-11-12

    This study sought to assess the independent effect of high-density lipoprotein-cholesterol (HDL-C) level on cardiovascular risk in patients with stable ischemic heart disease (SIHD) who were receiving optimal medical therapy (OMT). Although low HDL-C level is a powerful and independent predictor of cardiovascular risk, recent data suggest that this may not apply when low-density lipoprotein-cholesterol (LDL-C) is reduced to optimal levels using intensive statin therapy. We performed a post-hoc analysis in 2,193 men and women with SIHD from the COURAGE trial. The primary outcome measure was the composite of death from any cause or nonfatal myocardial infarction (MI). The independent association between HDL-C levels measured after 6 months on OMT and the rate of cardiovascular events after 4 years was assessed. Similar analyses were performed separately in subjects with LDL-C levels below 70 mg/dl (1.8 mmol/l). In the overall population, the rate of death/MI was 33% lower in the highest HDL-C quartile as compared with the lowest quartile, with quartile of HDL-C being a significant, independent predictor of death/MI (p = 0.05), but with no interaction for LDL-C category (p = 0.40). Among subjects with LDL-C levels <70 mg/dl, those in the highest quintile of HDL-C had a 65% relative risk reduction in death or MI as compared with the lowest quintile, with HDL-C quintile demonstrating a significant, inverse predictive effect (p = 0.02). In this post-hoc analysis, patients with SIHD continued to experience incremental cardiovascular risk associated with low HDL-C levels despite OMT during long-term follow-up. This relationship persisted and appeared more prominent even when LDL-C was reduced to optimal levels with intensive dyslipidemic therapy. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial

    PubMed Central

    Duncan, Pamela W; Sullivan, Katherine J; Behrman, Andrea L; Azen, Stanley P; Wu, Samuel S; Nadeau, Stephen E; Dobkin, Bruce H; Rose, Dorian K; Tilson, Julie K

    2007-01-01

    Background Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP), conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP) provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. Methods/Design We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a) LTP-Early; (b) LTP-Late or (c) Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean

  4. Post-study aspirin intake and factors motivating participation in a colorectal cancer chemoprevention trial.

    PubMed

    Sample, Dory A; Sinicrope, Pamela S; Wargovich, Michael J; Sinicrope, Frank A

    2002-03-01

    We conducted an exploratory, cross-sectional study examining motivators for study participation and post-study aspirin intake in a chemoprevention trial. The parent clinical trial aimed to determine the optimal aspirin dose for colorectal cancer chemoprevention using prostaglandin E(2) as a mucosal biomarker. This trial was randomized and double-blinded in 60 subjects with prior sporadic colorectal adenoma(s) and evaluated three aspirin doses or placebo taken once daily for 4 weeks. A cross-section of 55 evaluable participants who completed the chemoprevention trial were mailed a 16-item, self-administered questionnaire evaluating subject demographics, motivational factors, and health-related behaviors within the framework of Pender's Health Promotion Model (HPM). Forty-three (78%) of 55 participants returned the questionnaire. The most important motivators for study participation were altruistic, i.e., a desire to help future generations at risk of colorectal cancer and personal factors including a desire to reduce one's own risk. Nineteen (44%) of 43 respondents reported that they chose to take daily aspirin post-study without knowledge of study results. At a mean follow-up of 17.3 months, 18 of these 19 subjects continued to take aspirin regularly. Regular use of vitamin supplements pre-study was found to correlate with post-study aspirin use (Mann-Whitney U test, U = 154.0; P = 0.04). We demonstrate, for the first time, that participation in a chemoprevention study can influence the decision to continue the study drug, if available, to reduce perceived cancer risk. Continued post-study aspirin intake indicates an impact of study participation on a health-related behavior and underscores the importance of patient education to guide such decision-making.

  5. Longitudinal assessment of estimated glomerular filtration rate in apparently healthy adults: a post hoc analysis from the JUPITER study (justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin).

    PubMed

    Vidt, Donald G; Ridker, Paul M; Monyak, John T; Schreiber, Martin J; Cressman, Michael D

    2011-06-01

    Serum creatinine-based estimates of glomerular filtration rate (eGFR) are frequently used to identify patients with chronic kidney disease and assess cardiovascular risk both in clinical trials and in clinical practice. Although change in eGFR may be useful to assess change in renal function in patients with chronic kidney disease, the utility of serum creatinine-based eGFR is uncertain, particularly among individuals with normal or only mildly impaired renal function. The goal of this study was to examine the relationship between baseline serum creatinine and eGFR, as well as changes in these parameters, in apparently healthy adults in a post hoc analysis of data obtained in participants in the JUPITER study (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin). JUPITER was a randomized study of rosuvastatin 20 mg versus placebo in apparently healthy adults with high-sensitivity C-reactive protein levels ≥ 2.0 mg/L, LDL-C <130 mg/dL, and serum creatinine ≤ 2.0 mg/dL. Changes from baseline in serum creatinine and eGFR, based on the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations, were assessed in the entire population and in subsets classified according to baseline eGFR status. Baseline characteristics of the 16,279 JUPITER study participants (mean age, 66 years; 62% men; 72% white; and 58% with a history of hypertension) who had both a baseline and ≥ 1 postbaseline serum creatinine measurement were similar to the entire population of 17,802 patients who entered the trial. The mean age of the study population was 66 years, 62% were men, 72% were white, and 58% had a history of hypertension. Mean (SD) serum creatinine increased from baseline by 0.08 (0.16) mg/dL and 0.09 (0.14) mg/dL in the rosuvastatin and placebo groups, respectively (P = 0.001) at year 1 and by 0.09 (0.18) and 0.10 (0.16) mg/dL (P = 0.0045) at the final visit. Reductions in

  6. Technical success from endovascular aneurysm repair in the post-marketing era: a multicenter prospective trial.

    PubMed

    Naslund, Thomas C; Becker, Stacey Y

    2003-01-01

    Evaluation of post-marketing success with the Ancure Endovascular Graft (AEG) was accomplished by review of a multicenter, prospective trial involving 46 centers and 163 patients. A second cohort of patients (n = 350) treated with the AEG under a controlled-use interval prior to the prospective trial was simultaneously evaluated. Technical success in both groups of patients (96.9% and 97.4%, respectively) was similar to what was reported in pre-market clinical trials. Operative implantation complications unique to the AEG included graft limb stenosis/occlusion in 35.6 and 31.4%, contralateral pull wire being caught on hooks in 33.7 and 28%, failure to seal (type I endoleak) in 17.2 and 18.3%, jacket guard being stuck in 12.9 and 11%, contralateral wire being stuck in 6.8 and 7.1%, high jacket retraction force in 16 and 8.5%, and inability to retract jacket in 1.8 and 0.5% of patients involved in the multicenter trial and controlled-use interval, respectively. One of four patients undergoing conversion in the prospective trial had graft misdeployment as a mode of failure. Three were converted for access failure. The 30-day mortality rate in the prospective trial was 3.7%. Interventions to resolve implantation-related events included stenting, guide catheter manipulations, wire exchanges, and delivery catheter disassembly. These interventions were successful in virtually every case. Open surgical procedures were not needed to correct these operative problems. Results from this study demonstrate excellent technical success with the AEG in the post-market era. Interventions to resolve implantation complications, when utilized, are highly successful in facilitating AEG implantation and providing technical success.

  7. Intravenous dexamethasone versus ketamine gargle versus intravenous dexamethasone combined with ketamine gargle for evaluation of post-operative sore throat and hoarseness: A randomized, placebo-controlled, double blind clinical trial

    PubMed Central

    Safavi, Mohammadreza; Honarmand, Azim; Fariborzifar, Arghavan; Attari, Mohammadali

    2014-01-01

    Background: Sore throat and hoarseness are the most frequent subjective complaints after tracheal intubation for general anesthesia. We conducted a prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intravenous (IV) dexamethasone plus ketamine gargle for reducing the incidence and severity of post-operative sore throat (POST) and hoarseness. Materials and Methods: 140 patients (aged 16-65 year) scheduled for elective surgery were enrolled. Patients were randomly allocated into four groups of 35 subjects each: Group K, gargled 40 mg ketamine in 30 ml saline; Group D, were infused 0.2 mg/kg IV dexamethasone; Group KD, gargled 40 mg ketamine in 30 ml saline plus 0.2 mg/kg IV dexamethasone; Group P (placebo) that received saline (gargle and IV). POST was graded at 0, 2, 4, 8, 16 and 24 h after operation on a four-point scale (0-3). Results: The incidence and severity of POST were significantly lower in Group KD, compared with the other groups at all times after tracheal extubation for up to 24 h (P < 0.05). Also the incidence and severity of hoarseness were significantly lower in each Groups of KD and K and D compared with group placebo (P < 0.05). Conclusion: The prophylactic use of 0.2 mg/kg of IV dexamethasone plus ketamine gargle significantly reduced the incidence and severity of POST compared with using each of these drugs alone or using placebo. PMID:25371869

  8. Intravenous dexamethasone versus ketamine gargle versus intravenous dexamethasone combined with ketamine gargle for evaluation of post-operative sore throat and hoarseness: A randomized, placebo-controlled, double blind clinical trial.

    PubMed

    Safavi, Mohammadreza; Honarmand, Azim; Fariborzifar, Arghavan; Attari, Mohammadali

    2014-01-01

    Sore throat and hoarseness are the most frequent subjective complaints after tracheal intubation for general anesthesia. We conducted a prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intravenous (IV) dexamethasone plus ketamine gargle for reducing the incidence and severity of post-operative sore throat (POST) and hoarseness. 140 patients (aged 16-65 year) scheduled for elective surgery were enrolled. Patients were randomly allocated into four groups of 35 subjects each: Group K, gargled 40 mg ketamine in 30 ml saline; Group D, were infused 0.2 mg/kg IV dexamethasone; Group KD, gargled 40 mg ketamine in 30 ml saline plus 0.2 mg/kg IV dexamethasone; Group P (placebo) that received saline (gargle and IV). POST was graded at 0, 2, 4, 8, 16 and 24 h after operation on a four-point scale (0-3). The incidence and severity of POST were significantly lower in Group KD, compared with the other groups at all times after tracheal extubation for up to 24 h (P < 0.05). Also the incidence and severity of hoarseness were significantly lower in each Groups of KD and K and D compared with group placebo (P < 0.05). The prophylactic use of 0.2 mg/kg of IV dexamethasone plus ketamine gargle significantly reduced the incidence and severity of POST compared with using each of these drugs alone or using placebo.

  9. Cast metal vs. glass fibre posts: a randomized controlled trial with up to 3 years of follow up.

    PubMed

    Sarkis-Onofre, Rafael; Jacinto, Rogério de Castilho; Boscato, Noéli; Cenci, Maximiliano Sérgio; Pereira-Cenci, Tatiana

    2014-05-01

    This randomized controlled trial compared the survival of glass fibre and cast metal dental posts used to restore endodontically treated teeth with no remaining coronal wall. Fifty-four participants (45 women) and 72 teeth were evaluated during a follow-up period of up to 3 years. Teeth were randomly allocated to the glass-fibre and cast-metal post groups. All teeth were restored with single metal-ceramic crowns. Survival probabilities were analyzed using Kaplan-Meier statistics (p≤0.05). The 3-year recall rate was 92.3% and the survival rates of glass fibre and cast metal posts were similar (97.1% and 91.9%, respectively; p=0.682). Four failures were observed: two glass fibre posts in a premolar and anterior tooth debonded, one glass fibre post in a premolar debonded in association with root fracture, and one root fracture occurred in a molar with a cast metal post. Glass fibre and cast metal posts showed similar clinical performance in teeth with no remaining coronal wall after 3 years. Posts are used to restore most endodontically treated teeth with no remaining coronal wall. This randomized controlled trial, one of few to compare glass fibre and cast metal posts in such teeth, showed that post type did not significantly influence the survival of restorations. These results can help dentists respond to the important question of how best to rehabilitate endodontically treated teeth with no remaining coronal wall. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. QUIT EMR trial: a prospective, observational, multicentre study to evaluate quality and 24 hours post-transport morbidity of interhospital transportation of critically ill patients: study protocol

    PubMed Central

    Strauch, Ulrich; Bergmans, Dennis C J J; Habers, Joachim; Jansen, Jochen; Winkens, Bjorn; Veldman, Dirk J; Roekaerts, Paul M H J; Beckers, Stefan K

    2017-01-01

    Introduction It is widely accepted that transportation of critically ill patients is high risk. Unfortunately, however, there are currently no evidence-based criteria with which to determine the quality of various interhospital transport systems and their impact on the outcomes for patients. We aim to rectify this by assessing 2 scores which were developed in our hospital in a prospective, observational study. Primarily, we will be examining the Quality of interhospital critical care transportation in the Euregion Meuse-Rhine (QUIT EMR) score, which focuses on the quality of the transport system, and secondarily the SEMROS (Simplified EMR outcome score) which detects changes in the patient's clinical condition in the 24 hours following their transportation. Methods and analysis A web-based application will be used to document around 150 pretransport, intratransport and post-transport items of each patient case. To be included, patients must be at least 18-years of age and should have been supervised by a physician during an interhospital transport which was started in the study region. The quality of the QUIT EMR score will be assessed by comparing 3 predefined levels of transport facilities: the high, medium and low standards. Subsequently, SEMROS will be used to determine the effect of transport quality on the morbidity 24 hours after transportation. It is estimated that there will be roughly 3000 appropriate cases suitable for inclusion in this study per year. Cases shall be collected from 1 April 2015 until 31 December 2017. Ethics and dissemination This trial was approved by the Ethics committees of the university hospitals of Maastricht (Netherlands) and Aachen (Germany). The study results will be published in a peer reviewed journal. Results of this study will determine if a prospective randomised trial involving patients of various categories being randomly assigned to different levels of transportation system shall be conducted. Trial registration

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

    PubMed

    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.

  12. An SEM Approach for the Evaluation of Intervention Effects Using Pre-Post-Post Designs

    ERIC Educational Resources Information Center

    Mun, Eun Young; von Eye, Alexander; White, Helene R.

    2009-01-01

    This study analyzes latent change scores using latent curve models (LCMs) for evaluation research with pre-post-post designs. The article extends a recent article by Willoughby, Vandergrift, Blair, and Granger (2007) on the use of LCMs for studies with pre-post-post designs, and demonstrates that intervention effects can be better tested using…

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

    PubMed Central

    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

  14. A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches

    DTIC Science & Technology

    2009-05-01

    Medical Therapies for Chronic Post- Traumatic Headaches PRINCIPAL INVESTIGATOR: Jay Erickson, M.D., Ph.D...4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches 5b. GRANT...of propranolol, topiramate, and amitriptyline as treatments for chronic post-traumatic headaches secondary to combat-related mild head injury. The

  15. Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients

    PubMed Central

    Morel, Véronique; Joly, Dominique; Villatte, Christine; Dubray, Claude; Durando, Xavier; Daulhac, Laurence; Coudert, Catherine; Roux, Delphine; Pereira, Bruno; Pickering, Gisèle

    2016-01-01

    Background Neuropathic pain following surgical treatment for breast cancer with or without chemotherapy is a clinical burden and patients frequently report cognitive, emotional and quality of life impairment. A preclinical study recently showed that memantine administered before surgery may prevent neuropathic pain development and cognitive dysfunction. With a translational approach, a clinical trial has been carried out to evaluate whether memantine administered before and after mastectomy could prevent the development of neuropathic pain, the impairment of cognition and quality of life. Method A randomized, pilot clinical trial included 40 women undergoing mastectomy in the Oncology Department, University Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20) or placebo (n = 20) was administered for four weeks starting two weeks before surgery. The primary endpoint was pain intensity measured on a (0–10) numerical rating scale at three months post-mastectomy. Results Data analyses were performed using mixed models and the tests were two-sided, with a type I error set at α = 0.05. Compared with placebo, patients receiving memantine showed at three months a significant difference in post-mastectomy pain intensity, less rescue analgesia and a better emotional state. An improvement of pain symptoms induced by cancer chemotherapy was also reported. Conclusions This study shows for the first time the beneficial effect of memantine to prevent post-mastectomy pain development and to diminish chemotherapy-induced pain symptoms. The lesser analgesic consumption and better well-being of patients for at least six months after treatment suggests that memantine could be an interesting therapeutic option to diminish the burden of breast cancer therapy. Trial Registration Clinicaltrials.gov NCT01536314 PMID:27050431

  16. Nondestructive evaluation of timber highway guardrail posts

    Treesearch

    James P. Wacker; Xiping Wang; David E. Kretschmann; Douglas R. Rammer

    2010-01-01

    Timber post guardrail systems have been utilized in several regions of the U.S. due to their beneficial energy absorbing characteristics during vehicle impacts. These posts are not routinely inspected and replacement decisions are rather arbitrary. The Federal Highway Administration recently placed emphasis on new asset management strategies that actively assess...

  17. Treatment Trials for Post-Lyme Disease Symptoms Revisited

    PubMed Central

    Klempner, Mark S.; Baker, Phillip J.; Shapiro, Eugene D.; Marques, Adriana; Dattwyler, Raymond J.; Halperin, John J.; Wormser, Gary P.

    2014-01-01

    The authors of four National Institutes of Health (NIH)-sponsored antibiotic treatment trials of patients with persistent unexplained symptoms despite previous antibiotic treatment of Lyme disease determined that retreatment provides little if any benefit and carries significant risk. Recently, two groups have provided an independent reassessment of these trials and concluded that prolonged courses of antibiotics are likely to be helpful. We have carefully considered the points raised by these groups, along with our own critical review of the treatment trials. Based on this analysis, the conclusion that there is a meaningful clinical benefit to be gained from retreatment of such patients with parenteral antibiotic therapy cannot be justified. PMID:23764268

  18. Analgesic effect of magnesium in post-tonsillectomy patients: a prospective randomised clinical trial.

    PubMed

    Tugrul, S; Degirmenci, N; Eren, S B; Dogan, R; Veyseller, B; Ozturan, O

    2015-09-01

    The aim of this study was to assess the analgesic, bleeding and nausea/vomiting effects of magnesium with and without metamizol on post-tonsillectomy patients. This prospective and randomised clinical trial included 54 patients aged 18-63 years who were scheduled for elective tonsillectomy. The patients were randomly divided into two groups and administered either magnesium with metamizol or only metamizol. They had been classified as physical status class I and II using the American Society of Anesthesiologists guidelines. All patients underwent the same surgical procedure performed by a single surgeon. The groups did not differ according to age, sex, or duration of anaesthesia or surgery. Postoperative pain, bleeding and nausea/vomiting were evaluated using the VAS and bleeding and nausea/vomiting scores on the first, fifth and tenth days. On the first, fifth and tenth postoperative days, the VAS scores of the magnesium with metamizol group were significantly lower than those of the metamizol-only group (p1 = 0.001; p5 = 0.015; p10 = 0.015). There were no significant differences in postoperative bleeding and nausea/vomiting scores between the two groups (p = 0.425 and p = 0.258, respectively). This study showed that magnesium enhanced the analgesic effect on post-tonsillectomy pain. Use of magnesium with an analgesic drug may be beneficial for management of post-tonsillectomy pain.

  19. Review of Building Quality Using Post Occupancy Evaluation.

    ERIC Educational Resources Information Center

    Watson, Chris

    2003-01-01

    Describes post-occupancy evaluation of school buildings in terms of its aims, principles, benefits, methods, timing, and results. Offers three examples illustrating the evaluation of educational facilities in New Zealand. (EV)

  20. Evaluation of a simplified fiber post removal system.

    PubMed

    Scotti, Nicola; Bergantin, Emanuele; Alovisi, Mario; Pasqualini, Damiano; Berutti, Elio

    2013-11-01

    This study investigated the influence of clinical experience in relation to the efficacy and effectiveness of removal of 2 different fiber posts. In total, 48 intact single-rooted teeth were treated endodontically and obturated. Then, 10-mm post spaces were prepared, and fiber posts were luted. Twenty-four #1 D.T. Light-Posts were used in group 1, and 24 #2 Hi-Rem Prosthetic Posts were used in group 2. A pullout test (n = 8 per group) was performed by using a universal testing machine to compare bond strength. Then, fiber post removal efficacy and efficiency were tested. Each group was divided into 2 subgroups (n = 8) according to operator experience. In group 1, fiber posts were removed with an ultrasonic handpiece by using a #3 Start-X tip. In group 2, a size 25/0.04 ProFile was used to remove the central soft polymer macrofiber, and a #2 Largo drill was used to remove the fiber post and luting cement remnants. Post removal times were recorded to evaluate efficacy. Weight change was determined, and post space walls were analyzed microscopically to evaluate effectiveness. Bond strength did not differ significantly (P = .7569) between post systems. Post hoc Tukey tests indicated that removal time was affected significantly by operator experience in group 1 (P < .001) but not in group 2. Weight change was affected significantly by experience level in both groups. No difference in post space wall characteristics was observed between subgroups. The Hi-Rem post was easier to remove than the D.T Light-Post. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  1. Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles.

    PubMed

    Tang, Eve; Ravaud, Philippe; Riveros, Carolina; Perrodeau, Elodie; Dechartres, Agnes

    2015-08-14

    The reporting of serious adverse events (SAEs) in clinical trials is crucial to assess the balance between benefits and risks. For trials with serious adverse events posted at ClinicalTrials.gov, we assessed the consistency between SAEs posted at ClinicalTrials.gov and those published in corresponding journal articles. All records from ClinicalTrials.gov up to February 2014 were automatically exported in XML format. Among these, we identified all phase III or IV randomized controlled trials with at least one SAE posted. For a random sample of 300 of these trials, we searched for corresponding publications using MEDLINE via PubMed and extracted safety results from the articles. Among the sample of 300 trials with SAEs posted at ClinicalTrials.gov, 78 (26%) did not have a corresponding publication, and 20 (7%) had a publication that did not match the ClinicalTrials.gov record. For the 202 remaining trials, 26 published articles (13%) did not mention SAEs, 4 (2%) reported no SAEs, and 33 (16%) did not report the total number of SAEs per treatment group. Among the remaining 139 trials, for 44 (32%), the number of SAEs per group published did not match those posted at ClinicalTrials.gov. For 31 trials, the number of SAEs was greater at ClinicalTrials.gov than in the published article, with a difference ≥30 % for at least one group for 21. Only 33 trials (11%) had a publication reporting matching numbers of SAE and describing the type of SAE. Many trials with SAEs posted at ClinicalTrials.gov are not yet published, omit the reporting of these SAEs in corresponding publications, or report a discrepant number of SAEs as compared with ClinicalTrials.gov. These results underline the need to consult ClinicalTrials.gov for more information on serious harms.

  2. IVIG treatment in post-polio patients: evaluation of responders.

    PubMed

    Ostlund, Gunilla; Broman, Lisbet; Werhagen, Lars; Borg, Kristian

    2012-12-01

    The aim of this work is to evaluate the outcome of IVIG treatment in patients with post-polio syndrome (PPS) and to identify responders. The study included 113 PPS patients who had received one IVIG treatment in an open trial, prospective follow-up study. Clinical examination was performed and clinical data were retrieved from medical records. The short form 36 (SF-36), physical activity scale for the elderly (PASE), and the visual analogue scale (VAS) were used as measurements of quality of life, physical activity, and the intensity of pain. Data before treatment and at 6-month follow-up were collected. Analysis was performed in subgroups based on demographic and medical parameters. A statistically significant increase of the SF-36 sub domains bodily pain, vitality, social function, role emotional, and the mental compound score (MCS) was found at the 6-month follow-up. A significant decrease of pain was found in patients who reported pain intensity over VAS of 20 mm, in patients younger than 65 years of age and in patients who had paresis in the lower extremities. A trend was found in patients with PPS as the only diagnosis. IVIG leads to increase of quality of life at 6-month follow-up for SF-36 regarding sub domains of bodily pain, vitality, social function, role emotional, as well as for pain. Age below 65 years, paresis in the lower extremities, and lack of concomitant disorders may be the main indicators for a future identification of responders.

  3. Pre-, Post-, and Longitudinal Evaluation of Juvenile Justice Education.

    ERIC Educational Resources Information Center

    Major, Aline K.; Chester, Deborah R.; McEntire, Ranee; Waldo, Gordon P.; Blomberg, Thomas G.

    2002-01-01

    Describes two stages of the Juvenile Justice Educational Enhancement Program's pre-, post-, and longitudinal evaluation research and reports on the pilot studies used to explore how to design statewide research on pre- and post-assessment scores and community reintegration outcomes. Findings suggest that higher performing programs produce greater…

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

    PubMed

    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

    2017-07-05

    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.

  5. Attitudes toward Post-Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines.

    PubMed

    Cook, Kori; Snyder, Jeremy; Calvert, John

    2016-08-01

    There is currently no international consensus around post-trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post-trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post-trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post-trial access and participants and community members. Given that clinical trials conducted in low-income countries will likely continue, there is an urgent need for consideration of post-trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available.

  6. Fish Oil and Post-Operative Atrial Fibrillation – Results of the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA) Trial

    PubMed Central

    Mozaffarian, Dariush; Marchioli, Roberto; Macchia, Alejandro; Silletta, Maria G.; Ferrazzi, Paolo; Gardner, Timothy J.; Latini, Roberto; Libby, Peter; Lombardi, Federico; O’Gara, Patrick T.; Page, Richard L.; Tavazzi, Luigi; Tognoni, Gianni

    2013-01-01

    Context Post-operative atrial fibrillation/flutter (AF) is one of the most common complications of cardiac surgery and significantly increases morbidity and healthcare utilization. A few small trials have evaluated whether long-chain n-3-polyunsaturated fatty acids (PUFA) reduce post-op AF, with mixed results. Objective To determine whether peri-operative n-3-PUFA supplementation reduces post-op AF. Design Randomized, double-blind, placebo-controlled, multinational, clinical trial. Patients A total of 1,516 patients scheduled for cardiac surgery across 28 centers in the US, Italy, and Argentina, enrolled between Aug 2010 and Jun 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. Forty-eight percent of screened patients and 94% of eligible patients were enrolled. Intervention Patients were randomized to receive fish oil (1 g capsules containing ≥840 mg n-3-PUFA as ethyl esters) or placebo, with pre-operative loading of 10g over 3-5 days (or 8g over 2 days) followed post-operatively by 2g/d until hospital discharge or post-op day10, whichever first. Main Outcome Measures The primary endpoint was occurrence of post-op AF >30 sec. We also evaluated post-op AF lasting >1hr, resulting in symptoms, or treated with cardioversion; other secondary post-op AF endpoints; other tachyarrhythmias; hospital utilization; and major adverse cardiovascular events, 30-day mortality, bleeding, and other adverse events. All endpoints and analyses plans were prespecified. Results At enrollment, mean±SD age was 64±13 years, 72.2% were male, and 51.8% had planned valvular surgery. The primary endpoint occurred in 233 (30.7%) and 227 (30.0%) patients assigned to placebo and n-3-PUFA, respectively (OR=0.96, 95%CI=0.77-1.20; P=0.74). None of the secondary endpoints were significantly different, including post-op AF that was sustained, symptomatic, or treated (n=231 [30.5%] vs. n=224 [29.6%], P=0.70) or number of

  7. Evaluation of the effect of intra-operative intravenous fluid on post-operative pain and pulmonary function: a randomized trial comparing 10 and 30 ml kg(-1) of crystalloid.

    PubMed

    Straub, B D; Aslani, A; Enohumah, K; Rahore, R; Conrick-Martin, I; Kumar, D; Campbell, M; Dicker, P; Mocanu, E; Loughrey, J P; Hayes, N E; McCaul, C L

    2014-12-01

    Existing evidence suggests that administration of intravenous fluids has been shown to improve outcomes including pain in gynecological laparoscopic surgery but the optimum fluid dose has not been determined. To determine the effect of administration of intravenous fluids on post-operative pain and pulmonary function after gynecological laparoscopy. In a prospective randomized double-blinded study 100 ASA 1 and 2 elective patients undergoing gynecological laparoscopy were randomized to receive intravenous compound sodium lactate 10 ml kg(-1) (CSL10-restrictive) or 30 ml kg(-1) (CSL30-liberal) administered intra-operatively. The primary outcome measure was the post-operative pain score at 24, 48 and 72 h, assessed by 0-10 verbal rating scale (VRS). Pulmonary function (FEV1, FVC, PEFR) and oxygen saturation were also measured. Patients who received CSL 30 had lower post-operative pain scores than CSL 10 (ANCOVA-mean difference = 0.47, 95 % CI 0.11-0.83, P = 0.01). Post-operative pain VRS was lower in CSL30 than CSL10 at 48 h (mean difference 0.56, 95 % CI 0.04-1.09, P = 0.036). Patients in CSL30 reported shoulder tip pain less frequently than those in CSL10 (30.4 vs. 43.9 % of assessments, P = 0.03, OR 0.58) but reported wound pain more frequently 39.0 vs. 24.2 %, P = 0.01, OR 2.0). Indices of pulmonary function did not differ between groups at any time. Liberal compared to restrictive administration of i.v. crystalloid is associated with a clinical modest reduction in pain. Pulmonary dysfunction was not increased with liberal fluid administration.

  8. Part I--Evaluation of pediatric post-traumatic headaches.

    PubMed

    Pinchefsky, Elana; Dubrovsky, Alexander Sasha; Friedman, Debbie; Shevell, Michael

    2015-03-01

    Brain injury is one of the most common injuries in the pediatric age group, and post-traumatic headache is one of the most common symptoms following mild traumatic brain injury in children. This is an expert opinion-based two-part review on pediatric post-traumatic headaches. Part I will focus on an overview and approach to the evaluation of post-traumatic headache. Part II will focus on the medical management of post-traumatic headache. Relevant articles were reviewed, and an algorithm is proposed. We review the epidemiology, classification, pathophysiology, and clinical approach to evaluating patients with post-traumatic headache. A comprehensive history and physical examination are fundamental to identifying the headache type(s). Identifying the precise headache phenotype is important to help guide treatment. Most of the post-traumatic headaches are migraine or tension type, but occipital neuralgia, cervicogenic headache, and medication overuse headache also occur. Postconcussive signs often resolve within 1 month, and individuals whose signs persist longer may benefit from an interprofessional approach. Rigorous evaluation and diagnosis are vital to treating post-traumatic headaches effectively. A multifaceted approach is needed to address all the possible contributing factors to the headaches and any comorbid conditions that may delay recovery or alter treatment choices. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Post-liver transplantation sarcopenia in cirrhosis: a prospective evaluation.

    PubMed

    Tsien, Cynthia; Garber, Ari; Narayanan, Arvind; Shah, Shetal N; Barnes, David; Eghtesad, Bijan; Fung, John; McCullough, Arthur J; Dasarathy, Srinivasan

    2014-06-01

    Pre-transplant sarcopenia (reduced skeletal muscle mass) predicts poor outcome in cirrhosis. In contrast, whether muscle mass increases post-orthotopic liver transplantation (OLT) is not known and was studied prospectively. Consecutive patients who underwent a comprehensive nutritional evaluation in a liver transplant nutrition clinic were included. Core abdominal muscle area was measured on abdominal computed tomography obtained pre- and post-OLT. Age- and gender-based controls were used to define sarcopenia. Measures of body composition pre-transplant were correlated with computed tomography measurements. Predictors and clinical impact of post-OLT change in muscle area were examined. In three subjects post-OLT and three controls, expression of genes regulating skeletal muscle mass were quantified. During the study period, 53 patients (M:F 41:12; age 56.9 ± 7.5 years) were followed up after OLT for 19.3 ± 9 months. Five patients died and another five had acute graft rejection. Pre-OLT sarcopenia was present in 33 (66.2%). Pre-transplant clinical characteristics including Child's score, MELD score, and nutritional status or post-transplantation immunosuppression regimen did not predict post-transplant change in muscle mass. New onset post-OLT sarcopenia developed in 14 patients. Loss of muscle mass post-OLT increased risk of diabetes mellitus and a trend toward higher mortality. Skeletal muscle expression of myostatin was higher and that of ubiquitin proteasome proteolytic components lower post-OLT than in controls. Post-transplantation sarcopenia is common and could not be attributed to pre-transplant characteristics or the type or duration of post-OLT immunosuppression. Post-transplant sarcopenia contributes to adverse consequences and strategies targeting myostatin may be beneficial. © 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

  10. Evaluating Latent Variable Growth Models through Ex Post Simulation.

    ERIC Educational Resources Information Center

    Kaplan, David; George, Rani

    1998-01-01

    The use of ex post (historical) simulation statistics as means of evaluating latent growth models is considered, and a variety of simulation quality statistics are applied to such models. Results illustrate the importance of using these measures as adjuncts to more traditional forms of model evaluation. (SLD)

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

    SciTech Connect

    Logan, R.C.

    1999-06-22

    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.

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

    PubMed Central

    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. DEMOGRAPHIC AND HEALTH FACTORS ASSOCIATED WITH ENROLLMENT IN POST-TRIAL STUDIES: THE WOMEN’S HEALTH INITIATIVE HORMONE THERAPY TRIALS

    PubMed Central

    Espeland, Mark A.; Pettinger, Mary; Falkner, Karen L.; Shumaker, Sally A.; Limacher, Marian; Thomas, Fridtjof; Weaver, Kathryn E.; Stefanick, Marcia L.; McQuellon, Cynthia; Hunt, Julie R.; Johnson, Karen C.

    2014-01-01

    Background After clinical trials end, continued follow-up of the assembled cohort often is desirable for additional research. Factors influencing participants’ decisions to consent to additional follow-up and how these shape post-trial cohorts have not been broadly studied. Purpose We examined how two re-enrollment campaigns and the passage of time altered features of the post-trial cohorts compared with the original Women’s Health Initiative Hormone Therapy clinical trials. Methods We examined associations that markers of socio-demography, health, lifestyle and on-trial experiences had with re-enrollment and contrasted the characteristics of successive post-trial cohorts with those of the original enrollees. Results The post-trial enrollment campaigns re-enrolled 81.1% and 82.5% of available women, respectively. Women who re-enrolled tended to have better health characteristics than those not re-enrolled. Compared to women of comparable age in the original cohort, women retained for the second post-trial follow-up less often had a history of cardiovascular disease [odds ratio OR=0.36], hypertension [OR=0.57], diabetes [OR=0.59], or measured cognitive deficit [OR=0.40]. These women more often had graduated from high school [OR=1.72] and had participated in other WHI trials [OR=1.76]. Limitations We have examined experience with creating follow-up cohorst from participants in a single study. Thus, our findings may not apply to other cohorts and protocols. Conclusions Post-trial enrollment in follow-up studies can be successful; however the characteristics of the resulting cohort may differ substantially from the originally assembled group of trial participants. Collection during the original trial of potential predictors of differential re-enrollment may facilitate re-enrollment. PMID:23480899

  14. Online and post-trial feedback differentially affect implicit adaptation to a visuomotor rotation.

    PubMed

    Schween, Raphael; Taube, Wolfgang; Gollhofer, Albert; Leukel, Christian

    2014-09-01

    Multiple motor learning processes can be discriminated in visuomotor rotation paradigms. At least four processes have been proposed: Implicit adaptation updates an internal model based on prediction errors. Model-free reinforcement reinforces actions that achieve task success. Use-dependent learning favors repetition of prior movements, and strategic learning uses explicit knowledge about the task. The current experiment tested whether the processes involved in motor learning differ when visual feedback is altered. Specifically, we hypothesized that online and post-trial feedback would cause different amounts of implicit adaptation. Twenty subjects performed drawing movements to targets under a 45° counterclockwise visuomotor rotation while aiming at a clockwise adjacent target. Subjects received visual feedback via a cursor on a screen. One group saw the cursor throughout the movement (online feedback), while the other only saw the final position after movement execution (post-trial feedback). Both groups initially hit the target by applying the strategy. After 80 trials, subjects with online feedback had drifted in clockwise direction [mean direction error: 15.1° (SD 11.2°)], thus overcompensating the rotation. Subjects with post-trial feedback remained accurate [mean: 0.7° (SD 2.0°), TIME × F = 3.926, p = 0.003]. We interpret this overcompensation to reflect implicit adaptation isolated from other mechanisms, because it is driven by prediction error rather than task success (model-free reinforcement) or repetition (use-dependent learning). The current findings extend previous work (e.g., Mazzoni and Krakauer in J Neurosci 26:3642-3645, 2006; Hinder et al. in Exp Brain Res 201:191-207, 2010) and suggest that online feedback promotes more implicit adaptation than does post-trial feedback.

  15. Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain. Methods/Design The study is designed as a randomised controlled pilot trial with three arms and partial double blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms. The total observation period will begin one day before surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to ‘ready for discharge’ from the post anaesthesia care unit (in minutes). The ‘ready for discharge’ end point will be assessed using three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain, nausea and vomiting, concomitant medication). Discussion The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques. Trial registration NCT01816386 (First received: 28 October 2012) PMID:25047046

  16. Hyperbaric Oxygen Therapy Can Improve Post Concussion Syndrome Years after Mild Traumatic Brain Injury - Randomized Prospective Trial

    PubMed Central

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

    2013-01-01

    Background 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. Methods and Findings 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. Conclusions 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. Trial Registration ClinicalTrials.gov NCT00715052 PMID:24260334

  17. Repeat post-op voiding trials: an inconvenient correlate with success.

    PubMed

    Ferrante, Kimberly L; Kim, Hae-Young; Brubaker, Linda; Wai, Cliff Y; Norton, Peggy A; Kraus, Stephen R; Shepherd, Jonathan; Sirls, Larry T; Nager, Charles W

    2014-11-01

    This study examined the association between the need for a repeat voiding trial after midurethral sling (MUS) surgery and 1-year success rates. We conducted this secondary analysis of the participants in the Urinary Incontinence Treatment Network trial of midurethral sling (TOMUS) study which compared retropubic versus transobturator MUS. A standard voiding trial was attempted on all subjects. The "repeat voiding trial" group included subjects discharged with catheterization. All others were considered "self voiding." Success rates between the groups at 1-year were compared, followed by multivariate analyses controlling for previously reported clinical predictors of success. Most women (76%) were self-voiding, while 24% required a repeat voiding trial. The objective success rate at 1-year was 85.8% in the repeat voiding trial group and 75.3% in the self-voiding group (P = 0.01). Subjective success rate at 1-year was 61.0% in the repeat voiding trial group and 55.1% in the self-voiding group (P = 0.23). Women in the repeat voiding trial group continued to demonstrate greater objective success than the self-voiding group in multivariate analysis that controlled for previous incontinence surgery, pad weight, urethral mobility, urge score, and type of MUS (P = 0.04, OR 1.82, 95% CI 1.03-3.22). Women who require a repeat voiding trial following MUS surgery have greater objective success at 1-year postoperatively when compared to those who are self-voiding at the time of discharge. These results may help reassure women who require catheterization after MUS surgery that their outcome is not compromised by this immediate transient post-operative result. © 2013 Wiley Periodicals, Inc.

  18. Post Hoc Analysis of Data from Two Clinical Trials Evaluating the Minimal Clinically Important Change in International Restless Legs Syndrome Sum Score in Patients with Restless Legs Syndrome (Willis-Ekbom Disease).

    PubMed

    Ondo, William G; Grieger, Frank; Moran, Kimberly; Kohnen, Ralf; Roth, Thomas

    2016-01-01

    Determine the minimal clinically important change (MCIC), a measure determining the minimum change in scale score perceived as clinically beneficial, for the international restless legs syndrome (IRLS) and restless legs syndrome 6-item questionnaire (RLS-6) in patients with moderate to severe restless legs syndrome (RLS/Willis-Ekbom disease) treated with the rotigotine transdermal system. This post hoc analysis analyzed data from two 6-mo randomized, double-blind, placebo-controlled studies (SP790 [NCT00136045]; SP792 [NCT00135993]) individually and as a pooled analysis in rotigotine-treated patients, with baseline and end of maintenance IRLS and Clinical Global Impressions of change (CGI Item 2) scores available for analysis. An anchor-based approach and receiver operating characteristic (ROC) curves were used to determine the MCIC for the IRLS and RLS-6. We specifically compared "much improved vs minimally improved," "much improved/very much improved vs minimally improved or worse," and "minimally improved or better vs no change or worse" on the CGI-2 using the full analysis set (data as observed). The MCIC IRLS cut-off scores for SP790 and SP792 were similar. Using the pooled SP790+SP792 analysis, the MCIC total IRLS cut-off score (sensitivity, specificity) for "much improved vs minimally improved" was -9 (0.69, 0.66), for "much improved/very much improved vs minimally improved or worse" was -11 (0.81, 0.84), and for "minimally improved or better vs no change or worse" was -9 (0.79, 0.88). MCIC ROC cut-offs were also calculated for each RLS-6 item. In patients with RLS, the MCIC values derived in the current analysis provide a basis for defining meaningful clinical improvement based on changes in the IRLS and RLS-6 following treatment with rotigotine. © 2016 American Academy of Sleep Medicine.

  19. Improving Post-Hospitalization Transition Outcomes through Accessible Health Information Technology and Caregiver Support: Protocol for a Randomized Controlled Trial

    PubMed Central

    Piette, John D; Striplin, Dana; Marinec, Nicolle; Chen, Jenny; Gregory, Lynn A; Sumerlin, Denise L; DeSantis, Angela M; Gibson, Carolyn; Crause, Ingrid; Rouse, Marylena; Aikens, James E

    2015-01-01

    Objective The goal of this trial is to evaluate a novel intervention designed to improve post-hospitalization support for older adults with chronic conditions via: (a) direct tailored communication to patients using regular automated calls post discharge, (b) support for informal caregivers outside of the patient’s household via structured automated feedback about the patient’s status plus advice about how caregivers can help, and (c) support for care management including a web-based disease management tool and alerts about potential problems. Methods 846 older adults with common chronic conditions are being identified upon hospital admission. Patients are asked to identify a “CarePartner” (CP) living outside their household, i.e., an adult child or other social network member willing to play an active role in their post-discharge transition support. Patient-CP pairs are randomized to the intervention or usual care. Intervention patients receive automated assessment and behavior change calls, and their CPs receives structured feedback and advice via email and automated calls following each assessment. Clinical teams have access to assessment results via the web and receive automated reports about urgent health problems. Patients complete surveys at baseline, 30 days, and 90 days post discharge; utilization data is obtained from hospital records. CPs, other caregivers, and clinicians are interviewed to evaluate intervention effects on processes of self-care support, caregiver stress and communication, and the intervention’s potential for broader implementation. The primary outcome is 30-day readmission rates; other outcomes measured at 30 days and 90 days include functional status, self-care behaviors, and mortality risk. Conclusion This trial uses accessible health technologies and coordinated communication among informal caregivers and clinicians to fill the growing gap between what discharged patients need and available resources. A unique feature of

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

    PubMed

    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

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

    PubMed

    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.

  2. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

    PubMed

    Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

    2015-12-15

    Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and

  3. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial.

    PubMed

    Lao, Lixing; Huang, Yi; Feng, Chiguang; Berman, Brian M; Tan, Ming T

    2012-03-30

    Traditional Chinese medicine (TCM), used in China and other Asian counties for thousands of years, is increasingly utilized in Western countries. However, due to inherent differences in how Western medicine and this ancient modality are practiced, employing the so-called Western medicine-based gold standard research methods to evaluate TCM is challenging. This paper is a discussion of the obstacles inherent in the design and statistical analysis of clinical trials of TCM. It is based on our experience in designing and conducting a randomized controlled clinical trial of acupuncture for post-operative dental pain control in which acupuncture was shown to be statistically and significantly better than placebo in lengthening the median survival time to rescue drug. We demonstrate here that PH assumptions in the common Cox model did not hold in that trial and that TCM trials warrant more thoughtful modeling and more sophisticated models of statistical analysis. TCM study design entails all the challenges encountered in trials of drugs, devices, and surgical procedures in the Western medicine. We present possible solutions to some but leave many issues unresolved.

  4. Evaluation Studies of the Nuffield A-level Biology Trials - 5. Students after the Trials

    ERIC Educational Resources Information Center

    Kelly, P. J.

    1972-01-01

    The final part of a five-part series reporting the results of the evaluation of the trial version of the Nuffield A-level Biology Project presents data from a follow-up study of students one year after they completed the trials. Student perception of the objectives of the course is reported, and employer or supervisor comments on strengths and…

  5. Intra-Arterial Therapy and Post-Treatment Infarct Volumes: Insights From the ESCAPE Randomized Controlled Trial.

    PubMed

    Al-Ajlan, Fahad S; Goyal, Mayank; Demchuk, Andrew M; Minhas, Priyanka; Sabiq, Farahna; Assis, Zarina; Willinsky, Robert; Montanera, Walter J; Rempel, Jeremy L; Shuaib, Ashfaq; Thornton, John; Williams, David; Roy, Daniel; Poppe, Alexandre Y; Jovin, Tudor G; Sapkota, Biggya L; Baxter, Blaise W; Krings, Timo; Silver, Frank L; Frei, Donald F; Fanale, Christopher; Tampieri, Donatella; Teitelbaum, Jeanne; Lum, Cheemun; Dowlatshahi, Dar; Shankar, Jai J; Barber, Philip A; Hill, Michael D; Menon, Bijoy K

    2016-03-01

    The goal of reperfusion therapy in acute ischemic stroke is to limit brain infarction. The objective of this study was to investigate whether the beneficial effect of endovascular treatment on functional outcome could be explained by a reduction in post-treatment infarct volume. The Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial was a multicenter randomized open-label trial with blinded outcome evaluation. Among 315 enrolled subjects (endovascular treatment n=165; control n=150), 314 subject's infarct volumes at 24 to 48 hours on magnetic resonance imaging (n=254) or computed tomography (n=60) were measured. Post-treatment infarct volumes were compared by treatment assignment and recanalization/reperfusion status. Appropriate statistical models were used to assess relationship between baseline clinical and imaging variables, post-treatment infarct volume, and functional status at 90 days (modified Rankin Scale). Median post-treatment infarct volume in all subjects was 21 mL (interquartile range =65 mL), in the intervention arm, 15.5 mL (interquartile range =41.5 mL), and in the control arm, 33.5 mL (interquartile range =84 mL; P<0.01). Baseline National Institute of Health Stroke Scale (P<0.01), site of occlusion (P<0.01), baseline noncontrast computed tomographic scan Alberta Stroke Program Early CT score (ASPECTS) (P<0.01), and recanalization (P<0.01) were independently associated with post-treatment infarct volume, whereas age, sex, treatment type, intravenous alteplase, and time from onset to randomization were not (P>0.05). Post-treatment infarct volume (P<0.01) and delta National Institute of Health Stroke Scale (P<0.01) were independently associated with 90-day modified Rankin Scale, whereas laterality (left versus right) was not. These results support the primary results of the ESCAPE trial and show that the biological underpinning of the success of

  6. Ebola Virus Disease Candidate Vaccines Under Evaluation in Clinical Trials

    DTIC Science & Technology

    2016-06-02

    medical countermeasures. Viruses , 4(10), 2312-2316 (2012). 101. Bradfute SB. Duration of immune responses after Ebola virus vaccination. Lancet Infect Dis...Geisbert JB et al. Vesicular stomatitis virus -based vaccines protect nonhuman primates against aerosol challenge with Ebola and Marburg viruses ...Ebola virus vaccines 1 Ebola Virus Disease Candidate Vaccines Under Evaluation in Clinical Trials Keywords: candidate vaccine; clinical trial

  7. Field Testing of the Discrete-Trials Teaching Evaluation Form

    ERIC Educational Resources Information Center

    Jeanson, Brigitte; Thiessen, Carly; Thomson, Kendra; Vermeulen, Rhiannon; Martin, Garry L.; Yu, C. T.

    2010-01-01

    We assessed the reliability and validity of the discrete-trials teaching evaluation form (DTTEF), a 21-item checklist for assessing instructors conducting discrete-trials teaching (DTT). In Phase 1, six consultants in an applied behavior analysis program for children with autism rated the 21 components of the DTTEF with a mean of 6.2 on a 7-point…

  8. Mechanical and ultrastructural evaluation of quartz post-endodontic reconstructions.

    PubMed

    Majori, M; Bedini, R; Altamura, C; Filippini, P; Caiazza, S

    2004-01-01

    Aesthetics is a very important element in dentistry, but requires the support of good mechanical performance. Quartz fiber used in post-endodontic reconstruction is an aesthetic material, although there is little research concerning its mechanical properties. This study evaluated the retentive property of post-endodontic reconstruction, composed of a quartz fiber post. Different thermal stresses were applied in vitro to post-endodontic reconstructions, in order to simulate oral thermal action on post-system dental structure linkage. We chose 30 human extracted teeth, endodontically treated and restored, and then divided them into three groups of 10 teeth. A different treatment was applied to each group before mechanical testing: in the 1st group no treatment was done (controls); in the 2nd group teeth were subjected, in a climatic chamber, to 10 thermo-cycles between 4 degrees C and 58 degrees C; in the 3rd group teeth were stored in a saline solution at 37 degrees C for 48 hr. The teeth then underwent tensile shear stress tests at break point using a computerized electronic dynamometer. After mechanical testing, two teeth from each group were longitudinally half-sectioned, sputter-coated in gold and observed by scanning electron microscopy (SEM). The extracted quartz fiber post of each tooth also underwent SEM observation. Mechanical test results demonstrated that thermal cyclic variations could affect bond stability between dental structures and posts in quartz fiber reconstructions, whereas their bond strength seemed unaffected by humidity increases. Quartz fiber post SEM observation demonstrated a homogeneous structure and a regular fiber disposition. Dental root canal morphology SEM images always showed a different thickness in the cement layer. (Journal of Applied Biomaterials & Biomechanics 2004; 2: 156-61).

  9. A Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

    PubMed Central

    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.

    2012-01-01

    Background Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). Methods 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. Results 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). Conclusions 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.) PMID:22494121

  10. Evaluation of Different Post Lengths’ Effect on Fracture Resistance of a Glass Fiber Post System

    PubMed Central

    Adanir, Necdet; Belli, Sema

    2008-01-01

    Objectives The purpose of this in vitro study was to evaluate the influence of different post lengths upon root fracture resistance. Methods 78 maxillary central teeth with similar dimensions were mounted in acrylic blocks with artificial silicone periodontal ligaments. Combinations of post lengths of 6 mm (shorter than 1/1 clinical crown length), 9 mm (1/1 clinical crown length), and 12 mm (longer than 1/1 clinical crown length) made up 6 different groups consisting of 13 teeth each. The glass fiber posts (Snowpost) were cemented with Super-Bond C&B and Panavia F luting cement. Composite-resin cores were made with Clearfil PhotoCore. The specimens were tested in a universal test machine. The testing machine applied controlled loads to the core, 2 mm from its incisal edge, on the palatal side at an angle 135 degrees to the long axis of the root. The testing machine was set at a crosshead speed of 5mm per minute. All samples were loaded until failure. Results There was no statistically significant difference between cements (P>.05). Posts shorter than clinical crown length, demonstrated root fracture under significantly lower loading forces (P<.05). Conclusion Usage of posts shorter than clinical crowns should be avoided to eliminate clinical failure. PMID:19212505

  11. METHODOLOGICAL QUALITY OF ECONOMIC EVALUATIONS ALONGSIDE TRIALS OF KNEE PHYSIOTHERAPY.

    PubMed

    García-Pérez, Lidia; Linertová, Renata; Arvelo-Martín, Alejandro; Guerra-Marrero, Carolina; Martínez-Alberto, Carlos Enrique; Cuéllar-Pompa, Leticia; Escobar, Antonio; Serrano-Aguilar, Pedro

    2017-08-31

    The methodological quality of an economic evaluation performed alongside a clinical trial can be underestimated if the paper does not report key methodological features. This study discusses methodological assessment issues on the example of a systematic review on cost-effectiveness of physiotherapy for knee osteoarthritis. Six economic evaluation studies included in the systematic review and related clinical trials were assessed using the 10-question check-list by Drummond and the Physiotherapy Evidence Database (PEDro) scale. All economic evaluations were performed alongside a clinical trial but the studied interventions were too heterogeneous to be synthesized. Methodological quality of the economic evaluations reported in the papers was not free of drawbacks, and in some cases, it improved when information from the related clinical trial was taken into account. Economic evaluation papers dedicate little space to methodological features of related clinical trials; therefore, the methodological quality can be underestimated if evaluated separately from the trials. Future economic evaluations should follow more strictly the recommendations about methodology and the authors should pay special attention to the quality of reporting.

  12. Trial by Jury: A New Evaluation Method. I. The Process

    ERIC Educational Resources Information Center

    Wolf, Robert L.

    1975-01-01

    The judicial evaluation approach adapts and modifies certain concepts from both jury trials and administrative hearings in the field of law and relies on the law's acceptance of human testimony to clarify and, subsequently, to judge complex events. (Author)

  13. Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials

    PubMed Central

    Andersen, Jeppe Ragnar; Byrjalsen, Inger; Bihlet, Asger; Kalakou, Faidra; Hoeck, Hans Christian; Hansen, Gitte; Hansen, Henrik Bo; Karsdal, Morten Asser; Riis, Bente Juel

    2015-01-01

    AIM The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach. METHODS We used data from three randomized phase III trials monitored with a combination of complete SDV or partial SDV. After database lock, individual subject data were extracted from the clinical database and subjected to post hoc complete SDV. Error rates were calculated with focus on the degree of on study monitoring and relevance and analyzed for potential impact on end points. RESULTS Data from a total of 2566 subjects including more than 3 million data fields were 100% source data verified post hoc. An overall error rate of 0.45% was found. No sites had 0% errors. 100% SDV yielded an error rate of 0.27% as compared with partial SDV having an error rate of 0.53% (P < 0.0001). Comparing partly and fully monitored subjects, minor differences were identified between variables of major importance to efficacy or safety. CONCLUSIONS The findings challenge the notion that a 0% error rate is obtainable with on site monitoring. Data indicate consistently low error rates across the three trials analyzed. The use of complete vs. partial SDV offers a marginal absolute error rate reduction of 0.26%, i.e. a need to perform complete SDV of about 370 data points to avoid one unspecified error and does not support complete SDV as a means of providing meaningful improvements in data accuracy. PMID:25327707

  14. Differences in Treatment Effect Size Between Overall Survival and Progression-Free Survival in Immunotherapy Trials: A Meta-Epidemiologic Study of Trials With Results Posted at ClinicalTrials.gov.

    PubMed

    Tan, Aidan; Porcher, Raphael; Crequit, Perrine; Ravaud, Philippe; Dechartres, Agnes

    2017-05-20

    Purpose We aimed to compare treatment effect sizes between overall survival (OS) and progression-free survival (PFS) in trials of US Food and Drug Administration-approved oncology immunotherapy drugs with results posted at ClinicalTrials.gov . Methods We searched ClinicalTrials.gov for phase II to IV cancer trials of Food and Drug Administration-approved immunotherapy drugs and selected those reporting results for both OS and PFS. For each trial, we extracted the hazard ratios (HRs) with 95% CIs for both outcomes and evaluated the differences by a ratio of HRs (rHRs): the HR for PFS to that for OS. We performed a random effects meta-analysis across trials to obtain a summary rHR. We also evaluated surrogacy of PFS for OS by the coefficient of determination and the surrogacy threshold effect, the minimal value of HR for PFS to predict a non-null effect on OS. Results We identified 51 trials assessing 14 drugs across 15 conditions. Treatment effect sizes were 17% greater, on average, with PFS than with OS (rHR, 0.83; 95% CI, 0.79 to 0.88; I(2) = 34.4%; P = .01; τ(2) = 0.0129). Nearly one half of the trials (n = 23, 45%) showed statistically significant benefits for PFS but not for OS. Differences were great for trials of obinutuzumab (rHR, 0.21; 95% CI, 0.08 to 0.54), bevacizumab (rHR, 0.75; 95% CI, 0.67 to 0.84), and rituximab (rHR, 0.79; 95% CI, 0.64 to 0.98). The coefficient of determination was 38% and the surrogacy threshold effect was 0.50. Conclusion Treatment effect sizes in trials of immunotherapy drugs were greater for PFS than for OS, with important differences for some drugs, which is consistent with surrogacy metrics. Caution must be taken when interpreting PFS in the absence of OS data.

  15. Mediterranean Diet, Retinopathy, Nephropathy, and Microvascular Diabetes Complications: A Post Hoc Analysis of a Randomized Trial.

    PubMed

    Díaz-López, Andrés; Babio, Nancy; Martínez-González, Miguel A; Corella, Dolores; Amor, Antonio J; Fitó, Montse; Estruch, Ramon; Arós, Fernando; Gómez-Gracia, Enrique; Fiol, Miquel; Lapetra, José; Serra-Majem, Lluís; Basora, Josep; Basterra-Gortari, F Javier; Zanon-Moreno, Vicente; Muñoz, Miguel Ángel; Salas-Salvadó, Jordi

    2015-11-01

    To date no clinical trials have evaluated the role of dietary patterns on the incidence of microvascular diabetes complications. We hypothesized that a nutritional intervention based on the Mediterranean diet (MedDiet) would have greater protective effect on diabetic retinopathy and nephropathy than a low-fat control diet. This was a post hoc analysis of a cohort of patients with type 2 diabetes participating in the PREvención con DIeta MEDiterránea (PREDIMED) study, a multicenter randomized nutritional intervention trial conducted in a population at high cardiovascular risk. Individuals with type 2 diabetes who were free of microvascular complications at enrollment (n = 3,614, aged 55-80 years) were randomly assigned to one of three dietary interventions: MedDiet supplemented with extravirgin olive oil (MedDiet+EVOO), MedDiet supplemented with mixed nuts (MedDiet+Nuts), or a low-fat control diet. Two independent outcomes were considered: new onset of diabetic retinopathy and nephropathy. Hazard ratios (HRs) were calculated using multivariable-adjusted Cox regression. During a median follow-up of 6.0 years, we identified 74 new cases of retinopathy and 168 of nephropathy. Compared with the control diet, multivariable-adjusted HRs for diabetic retinopathy were 0.56 (95% CI 0.32-0.97) for the MedDiet+EVOO and 0.63 (0.35-1.11) for the MedDiet+Nuts. No between-group differences were found for nephropathy. When the yearly updated information on adherence to the MedDiet was considered, the HR for retinopathy in the highest versus the lowest quintile was 0.34 (0.13-0.89; P = 0.001 for trend). No significant associations were found for nephropathy. A MedDiet enriched with EVOO may protect against diabetic retinopathy but not diabetic nephropathy. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  16. [Intravenous lidocaine for post-mastectomy pain treatment: randomized, blind, placebo controlled clinical trial].

    PubMed

    Couceiro, Tania Cursino de Menezes; Lima, Luciana Cavalcanti; Burle, Léa Menezes Couceiro; Valença, Marcelo Moraes

    2015-01-01

    Postoperative pain treatment in mastectomy remains a major challenge despite the multimodal approach. The aim of this study was to investigate the analgesic effect of intravenous lidocaine in patients undergoing mastectomy, as well as the postoperative consumption of opioids. After approval by the Human Research Ethics Committee of the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, a randomized, blind, controlled trial was conducted with intravenous lidocaine at a dose of 3 mg/kg infused over one hour in 45 women undergoing mastectomy under general anesthesia. One patient from placebo group was Groups were similar in age, body mass index, type of surgery, and postoperative need for opioids. Two of 22 patients in lidocaine group and three of 22 patients in placebo group requested opioid (p=0.50). Pain on awakening was identified in 4/22 of lidocaine group and 5/22 of placebo group (p=0.50); in the post-anesthetic recovery room in 14/22 and 12/22 (p=0.37) of lidocaine and placebo groups, respectively. Pain evaluation 24hours after surgery showed that 2/22 and 3/22 patients (p=0.50) of lidocaine and placebo groups, respectively, complained of pain. Intravenous lidocaine at a dose of 3 mg/kg administered over a period of an hour during mastectomy did not promote additional analgesia compared to placebo in the first 24hours, and has not decreased opioid consumption. However, a beneficial effect of intravenous lidocaine in selected and/or other therapeutic regimens patients can not be ruled out. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  17. A General Framework for the Evaluation of Clinical Trial Quality

    PubMed Central

    Berger, Vance W.; Alperson, Sunny Y.

    2009-01-01

    Flawed evaluation of clinical trial quality allows flawed trials to thrive (get funded, obtain IRB approval, get published, serve as the basis of regulatory approval, and set policy). A reasonable evaluation of clinical trial quality must recognize that any one of a large number of potential biases could by itself completely invalidate the trial results. In addition, clever new ways to distort trial results toward a favored outcome may be devised at any time. Finally, the vested financial and other interests of those conducting the experiments and publishing the reports must cast suspicion on any inadequately reported aspect of clinical trial quality. Putting these ideas together, we see that an adequate evaluation of clinical quality would need to enumerate all known biases, update this list periodically, score the trial with regard to each potential bias on a scale of 0% to 100%, offer partial credit for only that which can be substantiated, and then multiply (not add) the component scores to obtain an overall score between 0% and 100%. We will demonstrate that current evaluations fall well short of these ideals. PMID:19463104

  18. Radiopacity of Esthetic Post Materials: Evaluation with Digital Analysis Technique.

    PubMed

    Kaval, Mehmet Emin; Akin, Hakan; Guneri, Pelin

    2017-07-01

    To evaluate the radiopacity of five post materials using a digital image analysis method. Twelve specimens from each post type (two zirconia and three fiber based) of 2 mm in thickness were obtained using a diamond blade mounted on a cutting machine, and digital radiographs were taken along with aluminum step-wedge and dentin discs under standard exposure conditions. The mean gray-values of specimens were measured using a computer graphics program. Data were analyzed using one-way ANOVA followed by Holm-Sidak multicomparison test (p = 0.05). The highest radiopacity was observed in custom zirconia (5.842 millimeters of equivalent Al [mmAl]), and the lowest value was detected with FRC-Postec (Ivoclar Vivadent) (1.716 mmAl). Significant differences were revealed between the radiopacity values among all groups (p < 0.05), except the Zr post materials (p = 0.56). All tested post materials had higher radiopacity than dentin. Further studies will be required to clarify optimum radiopacity properties of the post materials to provide a precise clinical observation. © 2015 by the American College of Prosthodontists.

  19. The post-evaluation of green residential building in Ningxia

    NASA Astrophysics Data System (ADS)

    Wu, Yunna; Wang, Zhen

    2017-06-01

    Green residential buildings are concerned by more and more people. However, the development of green residential buildings has been limited due to the single-standard requirements and lack of the multi-objective performance. At same time, the evaluation criteria system of green residential building is not comprehensive enough. So first of all, using SPSS software, residents questionnaire surveys are figured and found that the judge of experts and residents about the green elements is inconsistent, so the owners’ satisfaction is included in the post-evaluation criterial systems of green residential building from five aspects-the preliminary work of construction, construction process, economic, social benefits and owners satisfaction in Ningxia area, combined with expert interviews. Secondly, in the post-evaluation, it is difficult for many experts judgment matrix to meet the requirement of consistency, in this paper using MATLAB program, judgment matrix consistency is adjusted. And the weights of the criteria and sub-criteria and experts weights using group AHP method are determined. Finally, the grey clustering method is used to establish the post-evaluation model and the real case of Sai-shang project is carried out. It shows that the result obtained by using the improved criteria system and method in this paper is in a high degree of agreement with the actual result.

  20. An SEM Approach for the Evaluation of Intervention Effects Using Pre-Post-Post Designs

    PubMed Central

    Mun, Eun Young; von Eye, Alexander; White, Helene R.

    2010-01-01

    This study analyzes latent change scores using latent curve models (LCMs) for evaluation research with pre-post-post designs. The paper extends a recent article by Willoughby, Vandergrift, Blair, and Granger (2007) on the use of LCMs for studies with pre-post-post designs, and demonstrates that intervention effects can be better tested using different parameterizations of LCMs. This study illustrates how to test the overall mean of a latent variable at the time of research interest, not just at baseline, as well as means of latent change variables between assessments, and introduces how individual differences in the referent outcome (i.e., level-2 random effects) and measurement-specific residuals (i.e., level-1 residuals) can be modeled and interpreted. Two intervention data examples are presented. This LCM approach to change is more advantageous than other methods for its handling of measurement errors and individual differences in response to treatment, avoiding unrealistic assumptions, and being more powerful and flexible. PMID:20228953

  1. [Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

    PubMed

    Shimada, Yasuhiro

    2016-04-01

    The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment".

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

    PubMed

    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

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

    PubMed

    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 (GABAA) 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

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

    PubMed

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

    2016-09-22

    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.

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

    PubMed

    Faiz, Seyed Hamid Reza; Rahimzadeh, Poupak; Poornajafian, Alireza; Nikzad, Naghme

    2014-01-01

    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. 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. 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). The pain scale after surgery was reduced by using both ketamine and benzydamine, but the ketamine effect was more noticeable.

  6. Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial

    PubMed Central

    Seo, Han Gil; Paik, Nam-Jong; Lee, Shi-Uk; Oh, Byung-Mo; Chun, Min Ho; Kwon, Bum Sun; Bang, Moon Suk

    2015-01-01

    Background Botulinum toxin type A is widely used for treating spasticity. Neuronox (Neu-BoNT/A), a newly manufactured botulinum toxin a, has not yet been investigated for its efficacy and safety in the treatment of post-stroke upper limb spasticity. Objective We evaluated the efficacy and safety of Neuronox (Neu-BoNT/A) compared with BOTOX (onabotulinum toxin A) for treating post-stroke upper limb spasticity. Methods In total, 196 stroke patients with moderate to severe upper limb spasticity were randomly assigned to either Neuronox or BOTOX intervention. The wrist flexors were mandatory and elbow, finger, and thumb flexors were optional muscles to be injected. Assessments were performed at baseline and 4, 8, and 12 weeks after the intervention. The primary outcome measure was the change from baseline of the Modified Ashworth Scale (MAS) at the wrist flexors at week 4. Secondary outcome measures included the change of MAS at each visit, response rate, Disability Assessment Scale (DAS), Carer Burden Scale, and Global Assessment of treatment benefit. Results Primary outcome measures were -1.39±0.79 and -1.56±0.81 in the Neuronox and BOTOX groups, respectively. The difference was within the noninferiority margin of 0.45 (95% upper limit=0.40). There were no significant differences between the groups in the secondary outcome and safety measures, except the change of the MAS at the elbow flexors at week 12 (-0.88±0.75 in the Neuronox group, -0.65±0.74 in the BOTOX group; P=0.0429). Both groups showed significant improvements in the MAS, DAS, and Carer Burden Scale at weeks 4, 8, and 12. Conclusion Neuronox showed equivalent efficacy and safety compared with BOTOX for treating post-stroke upper limb spasticity. Trial Registration ClinicalTrials.gov NCT01313767 PMID:26030192

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    PubMed Central

    Fahlenkamp, Astrid V.; Stoppe, Christian; Cremer, Jan; Biener, Ingeborg A.; Peters, Dirk; Leuchter, Ricarda; Eisert, Albrecht; Apfel, Christian C.; Rossaint, Rolf; Coburn, Mark

    2016-01-01

    Objective 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. Methods 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. Results 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. Conclusion 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. Trial Registration EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT

  10. The acquisition, extinction and spontaneous recovery of Pavlovian drug conditioning induced by post-trial dopaminergic stimulation/inhibition.

    PubMed

    Santos, Breno Garone; Carey, Robert J; Carrera, Marinete Pinheiro

    2017-04-06

    In contextual drug conditioning, the onset of the drug treatment is contiguous with the contextual cues. Evidence suggests that drug conditioning also can occur if there is a discontinuity between the onset of the drug effect and offset of the contextual cues. Here we examine whether post-trial contextual drug conditioning conforms to several Pavlovian conditioning tenets namely: acquisition, extinction and spontaneous recovery. Six groups of rats received apomorphine (0.05 or 2.0mg/kg) and vehicle immediately or after a 15min delay following a 5min non-drug exposure to an open-field during three successive days (conditioning phase). The extinction phase occurred on days 4-8, in which all post-trial treatments were vehicle injections. After 2days of non-testing, the final test was performed. The results showed that on the first test day, the activity levels of the 6 groups were statistically equivalent. On test day 2, there were marked differences in activity levels selectively between the two immediate post-trial apomorphine treatment groups. The immediate low dose apomorphine group displayed a reduction in activity and the immediate high dose group an increase in activity relative to their day 1 levels. The activity levels of both vehicle groups and both apomorphine delay groups remained equivalent to their day 1 activity levels. On test day 3, the differences in activity levels between the two immediate post-trial apomorphine groups increased but the activity levels of the vehicle groups and the 15min delay post-trial apomorphine groups remained unchanged. In the extinction phase, the conditioned activity differences between the two immediate post-trial apomorphine groups were gradually eliminated. During the final test, the activity differences between the immediate post-trial apomorphine groups were partially restored, indicative of spontaneous recovery. These findings are consistent with several basic elements of Pavlovian conditioning and are supportive of

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

    PubMed Central

    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

  12. Post occupancy evaluation of primary schools in Saudi Arabia.

    PubMed

    Omari, Sana; Woodcock, Andree

    2012-01-01

    The physical school environment has been shown to be important in helping children fulfill their academic potential and in providing appropriate working conditions for staff. However, few tools have been developed that enable multi stakeholder consultation which takes into account the opinions of young students. In Saudi Arabia there has been widespread investment in schools, but few guidelines have been provided to assist design or continuous evaluation. A Post Occupancy Evaluation (POE) method was developed and used to evaluate three international primary schools in Saudi Arabia. The methods identified weaknesses in the three schools and differences in responses from the three groups consulted (children, teachers and parents). Conclusions drawn from the study are that greater efforts need to be made to draw together research about how school facilities can support teaching and learning, increase effectiveness and levels of satisfaction. POE, when used in conjunction with checklists could be used as a means of driving up standards of educational facilities.

  13. Competency to Proceed to Trial Evaluations and Rational Understanding.

    PubMed

    Ragatz, Laurie; Vitacco, Michael J; Tross, Rozanna

    2015-12-01

    In Dusky v. United States, the United States Supreme Court established "rational understanding" as a necessary component of a defendant's competency to stand trial. Yet, rational understanding has engendered misunderstanding, stemming from inconsistent court rulings and lack of systematic attention given to definitions of rationality. The purpose of this article is to assist with the conceptualization of rational understanding as it relates to competency to proceed to trial. This will be accomplished through a review of legal decisions and scholarly papers that provide various definitions of rationality. We discuss the suitability of standardized instruments of competency and how they may assist in providing a valid metric for evaluating rational abilities. We also provide discussion of how case law, in conjunction with psycholegal research, can be used to gain nuanced insight into operationalizations of rational understanding. By gaining a thorough understanding of rationality in competency to proceed to trial evaluations, clinicians may improve on the quality and foundation of their evaluations.

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

    PubMed Central

    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

    2017-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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

  15. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

    PubMed

    Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

    2011-10-01

    Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

  16. Metoclopramide or domperidone improves post-pyloric placement of spiral nasojejunal tubes in critically ill patients: a prospective, multicenter, open-label, randomized, controlled clinical trial.

    PubMed

    Hu, Bei; Ye, Heng; Sun, Cheng; Zhang, Yichen; Lao, Zhigang; Wu, Fanghong; Liu, Zhaohui; Huang, Linxi; Qu, Changchun; Xian, Lewu; Wu, Hao; Jiao, Yingjie; Liu, Junling; Cai, Juyu; Chen, Weiying; Nie, Zhiqiang; Liu, Zaiyi; Chen, Chunbo

    2015-02-13

    The use of prokinetic agents on post-pyloric placement of spiral nasojejunal tubes is controversial. The aim of the present study was to examine if metoclopramide or domperidone can increase the success rate of post-pyloric placement of spiral nasojejunal tubes. A multicenter, open-label, randomized, controlled trial was conducted in seven hospitals in China between April 2012 and February 2014. Patients admitted to the intensive care unit and requiring enteral nutrition for more than three days were randomly assigned to the metoclopramide, domperidone or control groups (1:1:1 ratio). The primary outcome was defined as the success rate of post-pyloric placement of spiral nasojejunal tubes, assessed 24 hours after initial placement. Secondary outcomes included success rate of post-D1, post-D2, post-D3 and proximal jejunum placement and tube migration distance. Safety of the study drugs and the tubes during the entire study period were recorded. In total, 307 patients were allocated to the metoclopramide (n = 103), domperidone (n = 100) or control group (n = 104). The success rate of post-pyloric placement after 24 hours in the metoclopramide, domperidone and control groups was 55.0%, 51.5% and 27.3%, respectively (P = 0.0001). Logistic regression analysis identified the use of prokinetic agents, Acute Physiology and Chronic Health Evaluation (APACHE) II score <20, Sequential Organ Failure Assessment (SOFA) score <12 and without vasopressor as independent factors influencing the success rate of post-pyloric placement. No serious drug-related adverse reaction was observed. Prokinetic agents, such as metoclopramide or domperidone, are effective at improving the success rate of post-pyloric placement of spiral nasojejunal tubes in critically ill patients. Chinese Clinical Trial Registry ChiCTR-TRC-12001956 . Registered 21 February 2012.

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

    NASA Technical Reports Server (NTRS)

    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.

  18. Low and high-frequency TENS in post-episiotomy pain relief: a randomized, double-blind clinical trial

    PubMed Central

    Pitangui, Ana C. R.; Araújo, Rodrigo C.; Bezerra, Michelle J. S.; Ribeiro, Camila O.; Nakano, Ana M. S.

    2014-01-01

    Objective To evaluate the effectiveness of low-frequency TENS (LFT) and high-frequency TENS (HFT) in post-episiotomy pain relief. Method A randomized, controlled, double-blind clinical trial with placebo composed of 33 puerperae with post-episiotomy pain. TENS was applied for 30 minutes to groups: HFT(100 Hz; 100 µs), LFT (5 Hz; 100 µs), and placebo (PT). Four electrodes were placed in parallel near the episiotomy and four pain evaluations were performed with the numeric rating scale. The first and the second evaluation took place before TENS application and immediately after its removal and were done in the resting position and in the activities of sitting and ambulating. The third and fourth evaluation took place 30 and 60 minutes after TENS removal, only in the resting position. Intragroup differences were verified using the Friedman and Wilcoxon tests, and the intergroup analysis employed the Kruskal-Wallis test. Results In the intragroup analysis, there was no significant difference in the PT during rest, sitting, and ambulation (P>0.05). In the HFT and LFT, a significant difference was observed in all activities (P<0.001). In the intergroup analysis, there was a significant difference in the resting position in the HFT and LFT (P<0.001). In the sitting activity, a significant difference was verified in the second evaluation in the HFT and LFT (P<0.008). No significant difference was verified among the groups in ambulation (P<0.20). Conclusions LFT and HFT are an effective resource that may be included in the routine of maternity wards. PMID:24675915

  19. Getting clinical trial results into practice: design, implementation, and process evaluation of the ALLHAT Dissemination Project

    PubMed Central

    Bartholomew, L Kay; Cushman, William C; Cutler, Jeffrey A; Davis, Barry R; Dawson, Glenna; Einhorn, Paula T; Graumlich, James F; Piller, Linda B; Pressel, Sara; Roccella, Edward J; Simpson, Lara; Whelton, Paul K; Williard, Angela

    2009-01-01

    Background Conventional dissemination of clinical trial results has inconsistent impact on physician practices. A more comprehensive plan to influence determinants of prescribing practices is warranted. Purpose To report the response from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial to the National Heart, Lung, and Blood Institute’s requirement for dissemination and evaluation of trials with potential immediate public health applicability. Methods ALLHAT’s dissemination plan had two-components: 1) a traditional approach of media coverage, scientific presentation and publication; and 2) a theory-based approach targeting determinants of clinician behavior. Strategies included (1) academic detailing, in which physicians approach colleagues regarding blood pressure management, (2) direct patient messages to stimulate communication with physicians regarding blood pressure control, (3) approaches to formulary systems to use educational and economic incentives for evidence-based prescription, and (4) direct professional organization appeals to clinicians. Results One hundred and forty-seven Investigator Educators reported 1698 presentations to 18,524 clinicians in 41 states and the District of Columbia. The pre- and post-test responses of 1709 clinicians in the face-to-face meetings indicated significant changes in expectations for positive patient outcomes and intention to prescribe diuretics. Information was mailed to 55 individuals representing 20 professional organizations and to eight formulary systems. Direct-to-patient messages were provided to 14 sites that host patient newsletters and Web sites such as health plans and insurance companies, 62 print mass media outlets, and 12 broadcast media sites. Limitations It was not within the scope of the project to conduct a randomized trial of the impact of the dissemination. However, impact evaluation using quasi-experimental designs is ongoing. Conclusions A large multi

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

    PubMed

    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. Association between diabetes mellitus and post-discharge outcomes in patients hospitalized with heart failure: findings from the EVEREST trial.

    PubMed

    Sarma, Satyam; Mentz, Robert J; Kwasny, Mary J; Fought, Angela J; Huffman, Mark; Subacius, Haris; Nodari, Savina; Konstam, Marvin; Swedberg, Karl; Maggioni, Aldo P; Zannad, Faiez; Bonow, Robert O; Gheorghiade, Mihai

    2013-02-01

    We evaluated the impact of diabetes mellitus (DM) and diabetic therapy on outcomes in patients with reduced ejection fraction (EF) after hospitalization for heart failure (HF). DM is prevalent in patients hospitalized with HF, yet inconclusive data exist on the post-discharge outcomes of this patient population. Post-hoc analysis was performed on the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan) study, a randomized trial of patients hospitalized with HF (n = 4133) with median follow-up of 9.9 months. DM status was determined from intake questionnaires and cross-verified by medication history. Univariate relationships were examined using χ(2) test, t-test, and Wilcoxon tests. The two primary outcomes of (i) all-cause mortality (ACM) and (ii) cardiovascular mortality or HF hospitalization (CVM + HFH) were assessed for those with and without DM and by diabetic treatment strategy using log rank tests and multivariable Cox regression models. DM was present in 40% of participants. Patients with DM were more likely to have hypertension, coronary artery disease, and chronic kidney disease. Diabetes was associated with ACM and CVM + HFH (both P < 0.001). Following multivariate risk adjustment, DM was associated with ACM, but this estimate was imprecise [hazard ratio (HR) 1.16; 95% confidence interval (CI) 1.00-1.34] and remained associated with CVM or HFH (HR 1.17; 95% CI 1.04-1.31). Diabetic control strategy did not independently affect outcomes. Diabetes is common in patients hospitalized for heart failure with a reduced EF. These patients have a higher post-discharge CVM and higher HF hospitalizations compared with patients with no diabetes. Different diabetic treatment regimens did not appear to influence post-discharge outcomes.

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

    PubMed

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-07-20

    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). 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.

  3. 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

    PubMed Central

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

    2016-01-01

    Background 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. Methods 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. Results 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. Conclusions The implementation of a large-sale, evidence based HIV intervention requires extensive QAC to ensure implementation effectiveness

  4. 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.

    PubMed

    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

  5. Evaluating Library Buildings: Principles and Procedures for Post-Occupancy Evaluation.

    ERIC Educational Resources Information Center

    Kusack, James M.

    This manual provides the steps in planning a post-occupancy evaluation of library facilities to determine how effective the designed environment is for users. Evaluating a building provides a feedback loop to the planning process and can help fine tune the building or help others. The first actions of the planners are to clarify the purpose; gain…

  6. A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches

    DTIC Science & Technology

    2011-05-01

    blinded, placebo-controlled clinical trial was conducted to evaluate the effectiveness of propranolol , topiramate, and amitriptyline as treatments for... propranolol arm (-41%, p=0.10), and 9.3 to 8.8 in the topiramate arm (-5%, p=0.80). Mean MIDAS scores decreased from 71 at baseline to 31 at the...final visit among all subjects (p=0.0001) and significantly declined in the placebo, topiramate, and propranolol arms. PTSD symptom checklist scores

  7. Post-procedural evaluation of catheter contact force characteristics

    NASA Astrophysics Data System (ADS)

    Koch, Martin; Brost, Alexander; Kiraly, Atilla; Strobel, Norbert; Hornegger, Joachim

    2012-03-01

    Minimally invasive catheter ablation of electric foci, performed in electrophysiology labs, is an attractive treatment option for atrial fibrillation (AF) - in particular if drug therapy is no longer effective or tolerated. There are different strategies to eliminate the electric foci inducing the arrhythmia. Independent of the particular strategy, it is essential to place transmural lesions. The impact of catheter contact force on the generated lesion quality has been investigated recently, and first results are promising. There are different approaches to measure catheter-tissue contact. Besides traditional haptic feedback, there are new technologies either relying on catheter tip-to-tissue contact force or on local impedance measurements at the tip of the catheter. In this paper, we present a novel tool for post-procedural ablation point evaluation and visualization of contact force characteristics. Our method is based on localizing ablation points set during AF ablation procedures. The 3-D point positions are stored together with lesion specific catheter contact force (CF) values recorded during the ablation. The force records are mapped to the spatial 3-D positions, where the energy has been applied. The tracked positions of the ablation points can be further used to generate a 3-D mesh model of the left atrium (LA). Since our approach facilitates visualization of different force characteristics for post-procedural evaluation and verification, it has the potential to improve outcome by highlighting areas where lesion quality may be less than desired.

  8. Constraint-induced aphasia therapy in post-stroke aphasia rehabilitation: A systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    Bao, Yong; Xie, Qing; Xu, Yang; Zhang, Junmei

    2017-01-01

    Background Constraint-induced aphasia therapy (CIAT) has been widely used in post-stroke aphasia rehabilitation. An increasing number of clinical controlled trials have investigated the efficacy of the CIAT for the post-stroke aphasia. Purpose To systematically review the randomized controlled trials (RCTs) concerning the effect of the CIAT in post-stroke patients with aphasia, and to identify the useful components of CIAT in post-stroke aphasia rehabilitation. Methods A computerized database search was performed through five databases (Pubmed, EMbase, Medline, ScienceDirect and Cochrane library). Cochrane handbook domains were used to evaluate the methodological quality of the included RCTs. Results Eight RCTs qualified in the inclusion criteria. Inconsistent results were found in comparing the CIAT with conventional therapies without any component from the CIAT based on the results of three RCTs. Five RCTs showed that the CIAT performed equally well as other intensive aphasia therapies, in terms of improving language performance. One RCT showed that therapies embedded with social interaction were likely to enhance the efficacy of the CIAT. Conclusion CIAT may be useful for improving chronic post-stroke aphasia, however, limited evidence to support its superiority to other aphasia therapies. Massed practice is likely to be a useful component of CIAT, while the role of “constraint” is needed to be further explored. CIAT embedded with social interaction may gain more benefits. PMID:28846724

  9. Constraint-induced aphasia therapy in post-stroke aphasia rehabilitation: A systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Zhang, Jiaqi; Yu, Jiadan; Bao, Yong; Xie, Qing; Xu, Yang; Zhang, Junmei; Wang, Pu

    2017-01-01

    Constraint-induced aphasia therapy (CIAT) has been widely used in post-stroke aphasia rehabilitation. An increasing number of clinical controlled trials have investigated the efficacy of the CIAT for the post-stroke aphasia. To systematically review the randomized controlled trials (RCTs) concerning the effect of the CIAT in post-stroke patients with aphasia, and to identify the useful components of CIAT in post-stroke aphasia rehabilitation. A computerized database search was performed through five databases (Pubmed, EMbase, Medline, ScienceDirect and Cochrane library). Cochrane handbook domains were used to evaluate the methodological quality of the included RCTs. Eight RCTs qualified in the inclusion criteria. Inconsistent results were found in comparing the CIAT with conventional therapies without any component from the CIAT based on the results of three RCTs. Five RCTs showed that the CIAT performed equally well as other intensive aphasia therapies, in terms of improving language performance. One RCT showed that therapies embedded with social interaction were likely to enhance the efficacy of the CIAT. CIAT may be useful for improving chronic post-stroke aphasia, however, limited evidence to support its superiority to other aphasia therapies. Massed practice is likely to be a useful component of CIAT, while the role of "constraint" is needed to be further explored. CIAT embedded with social interaction may gain more benefits.

  10. The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial.

    PubMed

    Duncan, Pamela W; Bushnell, Cheryl D; Rosamond, Wayne D; Jones Berkeley, Sara B; Gesell, Sabina B; D'Agostino, Ralph B; Ambrosius, Walter T; Barton-Percival, Blair; Bettger, Janet Prvu; Coleman, Sylvia W; Cummings, Doyle M; Freburger, Janet K; Halladay, Jacqueline; Johnson, Anna M; Kucharska-Newton, Anna M; Lundy-Lamm, Gladys; Lutz, Barbara J; Mettam, Laurie H; Pastva, Amy M; Sissine, Mysha E; Vetter, Betsy

    2017-07-17

    Patients discharged home after stroke face significant challenges managing residual neurological deficits, secondary prevention, and pre-existing chronic conditions. Post-discharge care is often fragmented leading to increased healthcare costs, readmissions, and sub-optimal utilization of rehabilitation and community services. The COMprehensive Post-Acute Stroke Services (COMPASS) Study is an ongoing cluster-randomized pragmatic trial to assess the effectiveness of a comprehensive, evidence-based, post-acute care model on patient-centered outcomes. Forty-one hospitals in North Carolina were randomized (as 40 units) to either implement the COMPASS care model or continue their usual care. The recruitment goal is 6000 patients (3000 per arm). Hospital staff ascertain and enroll patients discharged home with a clinical diagnosis of stroke or transient ischemic attack. Patients discharged from intervention hospitals receive 2-day telephone follow-up; a comprehensive clinic visit within 2 weeks that includes a neurological evaluation, assessments of social and functional determinants of health, and an individualized COMPASS Care Plan™ integrated with a community-specific resource database; and additional follow-up calls at 30 and 60 days post-stroke discharge. This model is consistent with the Centers for Medicare and Medicaid Services transitional care management services provided by physicians or advanced practice providers with support from a nurse to conduct patient assessments and coordinate follow-up services. Patients discharged from usual care hospitals represent the control group and receive the standard of care in place at that hospital. Patient-centered outcomes are collected from telephone surveys administered at 90 days. The primary endpoint is patient-reported functional status as measured by the Stroke Impact Scale 16. Secondary outcomes are: caregiver strain, all-cause readmissions, mortality, healthcare utilization, and medication adherence. The

  11. Improving attendance at post-emergency department follow-up via automated text message appointment reminders: a randomized controlled trial.

    PubMed

    Arora, Sanjay; Burner, Elizabeth; Terp, Sophie; Nok Lam, Chun; Nercisian, Aren; Bhatt, Vivek; Menchine, Michael

    2015-01-01

    Patients discharged from the emergency department (ED) are often referred for primary care, specialty, or other disease-specific follow-up appointments. Attendance at these scheduled follow-up appointments has been found to improve patient outcomes, decrease ED bounce-backs, and reduce malpractice risk. Reasons for missing follow-up visits are complex, but the most commonly reason cited by patients is simply forgetting. In this study the authors evaluated the ability of an automated text message reminder system to increase attendance at post-ED discharge follow-up appointments in a predominantly Hispanic safety-net population. This was a randomized controlled trial of ED patients with outpatient follow-up visits scheduled at the time of ED discharge. A total of 374 English- and Spanish-speaking patients with text-capable mobile phones were enrolled. Patients in the intervention arm received automated, personalized text message appointment reminders including date, time, and clinic location at 7, 3, and 1 day before scheduled visits. A t-test of proportions was used to compare outcomes between intervention and control groups. Both an intention-to-treat (ITT) and a per-protocol analysis of the data were performed. The ITT more accurately reflects real-world conditions where errors such as number entry errors are bound to occur. The per-protocol analysis adds value by isolating the effect of the intervention by comparing patients who actually received it compared with those who did not. In the per-protocol analysis of the primary outcome, the overall appointment adherence rate was 72.6% in the intervention group compared with 62.1% in the control group (difference between groups = 10.5%, 95% confidence interval [CI] = 0.3% to 20.8%; p = 0.045; number needed to treat = 9.5). In the ITT analysis, the overall appointment attendance rate 70.2% in the intervention group compared with 62.1% in the control group (difference between groups = 8.2%; 95% CI = -1.6% to 17.7%; p

  12. Effect of acupressure on post-operative nausea and vomiting in cesarean section: a randomised controlled trial.

    PubMed

    A, Direkvand-Moghadam; A, Khosravi

    2013-10-01

    Because of potential side effects of chemical treatments and in order to decrease the risk of nausea and vomiting in post-operative patients, there is a necessary requirement for some alternative therapeutic methods such as Acupressure. The present randomized clinical trial study aimed to compare the effects of Acupressure and Metoclopramide on postoperative nausea and vomiting in Caesarean Sections. The patients who were subjected to caesarean surgeries, who were referred to the Ilam Mustafa Hospital in the west of Iran, were enrolled in this randomised clinical trial study. Totally, 102 patients who were selected for elective Caesarean Section were included in this study. Patients were randomly assigned to one of three groups, with 34 cases in each group. All groups were matched for effective factors on nausea and vomiting in inclusion and exclusion criteria. The control group did not receive any intervention, the second group received 10 mg Metoclopramide intravenously, immediately prior to anaesthesia induction and in the third group, Acupressure bands were applied at the P6 points on both wrists, 15 minutes before anaesthesia induction. Intra-operative and post-operative emetic episodes were recorded by a trained investigator. The patients who experienced nausea were evaluated on a linear numeric scale which ranged from 0 (no) to 10 (severe). Statistics and Results: The incidence of nausea and vomiting in postoperative periods was lower in Metoclopramide and Acupressure groups as compared that in the control group. The frequency of anti-emetic which was used was significantly higher in control group as compared to those in the other groups (p<0.001). No side effects or complications were caused by any intervention. In parturients who underwent caesarean deliveries which were performed under spinal anaesthesia in this study, use of Metoclopramide and Acupressure was found to be equally effective for reducing emetic symptoms (nausea, retching, and vomiting).

  13. Honey plus coffee versus systemic steroid in the treatment of persistent post-infectious cough: a randomised controlled trial.

    PubMed

    Raeessi, Mohammad Ali; Aslani, Jafar; Raeessi, Neda; Gharaie, Homa; Karimi Zarchi, Ali Akbar; Raeessi, Fereshteh

    2013-09-01

    Persistent post-infectious cough (PPC) is a cough that remains after a common cold or an upper respiratory tract infection for more than three weeks or perhaps for many months. Two of the suggested treatments for PPC are systemic steroid and honey plus coffee. The aim of this study was to evaluate and compare scientifically the therapeutic effects of these two regimens. A double-blind randomised controlled trial was conducted from 2008 to 2011 at the Baqiyatallah University Hospital, Tehran, Iran. Included in the study were 97 adults who had experienced PPC for more than three weeks. Patients with other causes of chronic cough, systemic disease, or abnormal routine laboratory tests were excluded. The participants were distributed into three groups. A jam like paste was prepared which consisted of honey plus coffee for the first group ('HC'), prednisolone for the second group (steroid, 'S'), and guaifenesin for the third group (control, 'C'). The participants were told to dissolve a specified amount of their product in warm water and to drink the solution every eight hours for one week. All the participants were evaluated before treatment and one week after completion of treatment to measure the severity of their cough. The main outcome measure was the mean cough frequency before and after one week's treatment calculated by a validated visual analogue cough questionnaire score. There were 97 adult patients (55 men) enrolled in this study with the mean of age of 40.1 years. The mean (+/- SD) cough scores pre- and post-treatment were: HC group 2.9 (0.3) pre-treatment and 0.2 (0.5) post-treatment (p < 0.001); steroid ('S') group 3.0 (0.0) pre-treatment and 2.4 (0.6) post-treatment (p < 0.05); control ('C') group 2.8 (0.4) pre-treatment and 2.7 (0.5) post-treatment (p > 0.05). Analysis of variance showed a significant difference between the mean cough frequency before and after treatment in the HC group versus the S group (p< 0.001). Honey plus coffee was found to be

  14. Evaluating a community-partnered cancer clinical trials pilot intervention with African American communities.

    PubMed

    Green, Melissa A; Michaels, Margo; Blakeney, Natasha; Odulana, Adebowale A; Isler, Malika Roman; Richmond, Alan; Long, Debra G; Robinson, William S; Taylor, Yhenneko J; Corbie-Smith, Giselle

    2015-03-01

    Cancer clinical trial (CCT) accrual and retention rates remain disproportionately low among African Americans. Awarenesss and access to trials are crucial facilitators of trial participation. Strategies developed within a community-based participatory framework (CBPR) are potential solutions to increase awareness and access to CCTs. In this study, we describe the pilot phase of three innovative community-centered modules to improve basic CCT knowledge, awareness of locations to access CCT information, and opportunities to participate in CCTs. Four community organizations completed Community Bridges to CCT training-of-the-trainer and recruited adult African American volunteers to participate in one of three CCT education modules: a workshop about CCTs, a role play describing one person's experience with CCTs, or a call and response session reviewing myths and facts about CCTs. Pre- and post-test surveys were collected and analyzed using McNemar agreement statistic to evaluate changes in knowledge and attitudes regarding trials. Trainers enrolled 125 participants in the call and response (n = 22), role play (n = 60), and workshop (n = 43) modules. Module participants were mostly African American, female, and with a mean age of 53 years. Comparison of pre- and post-test responses demonstrates favorable changes in awareness of CCTs and where to access CCTs across the sample. Analysis by module type indicates significant increases for participants in the call and response (p < 0.01) and role play modules (p < 0.001), but not the workshop module. Despite measures taken to increase the participation and retention rate of African Americans in clinical trials, little advancement has been made. Developing tailored community education modules on CCTs within the CBPR framework is a promising innovation to increase knowledge about CCTs and favorable attitudes about participation that are known precursors to trial enrollment.

  15. Evaluating a Community-Partnered Cancer Clinical Trials Pilot Intervention with African American Communities

    PubMed Central

    Green, Melissa A.; Michaels, Margo; Blakeney, Natasha; Odulana, Adebowale A.; Isler, Malika Roman; Richmond, Alan; Long, Debra G.; Robinson, William S.; Taylor, Yhenneko J.; Corbie-Smith, Giselle

    2015-01-01

    Objectives Cancer Clinical Trial (CCT) accrual and retention rates remain disproportionately low among African Americans. Awareness and access to trials are crucial facilitators of trial participation. Strategies developed within a community-based participatory framework (CBPR) are potential solutions to increase awareness and access to CCTs. In this study, we describe the pilot phase of three innovative community-centered modules to improve basic CCT knowledge, awareness of locations to access CCT information, and opportunities to participate in CCTs. Design Four community organizations completed Community Bridges to CCTs training-of-the trainer and recruited adult African American volunteers to participate in one of three CCT education modules: a workshop about CCTs; a role-play describing one person's experience with CCTs; or a call and response session reviewing myths and facts about CCTs. Pre- and post-test surveys were collected and analyzed using McNemar agreement statistic to evaluate changes in knowledge and attitudes regarding trials. Results Trainers enrolled 125 participants in the Call and Response (n=22), Role-play (n=60), and Workshop (n=43) modules. Module participants were mostly African American, female, and mean age of 53 years. Comparison of pre and post-test responses demonstrates favorable changes in awareness of CCTs and where to access to CCTs across the sample. Analysis by module type indicates significant increases for participants in the Call and Response (p < 0.01) and Role-Play modules (p < 0.001), but not the Workshop module. Conclusion Despite measures taken to increase the participation and retention rate of African Americans in clinical trials, little advancement has been made. Developing tailored community education modules on CCTs within the CBPR framework is a promising innovation to increase knowledge about CCTs and favorable attitudes about participation that are known precursors to trial enrollment. PMID:25564207

  16. Cross-System Evaluation of Clinical Trial Search Engines

    PubMed Central

    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. PMID:25954590

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

    PubMed

    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.

  18. A post hoc analysis of subgroup outcomes and creatinine in the phase III clinical trial (EMPOWER) of dexpramipexole in ALS.

    PubMed

    Bozik, Michael E; Mitsumoto, Hiroshi; Brooks, Benjamin R; Rudnicki, Stacy A; Moore, Dan H; Zhang, Bing; Ludolph, Albert; Cudkowicz, Merit E; van den Berg, Leonard H; Mather, James; Petzinger, Thomas; Archibald, Donald

    2014-09-01

    Our objective was to compare the phase II and phase III (EMPOWER) studies of dexpramipexole in ALS and evaluate potential EMPOWER responder subgroups and biomarkers based on significant inter-study population differences. In a post hoc analysis, we compared the baseline population characteristics of both dexpramipexole studies and analyzed EMPOWER efficacy outcomes and laboratory measures in subgroups defined by significant inter-study differences. Results showed that, compared with phase II, the proportion of El Escorial criteria (EEC) definite participants decreased (p = 0.005), riluzole use increased (p = 0.002), and mean symptom duration increased (p = 0.037) significantly in EMPOWER. Baseline creatinine (p < 0.001) and on-study creatinine change (p < 0.001) correlated significantly with ALSFRS-R in EMPOWER. In the EMPOWER subgroup defined by EEC-definite ALS, riluzole use, and < median symptom duration (15.3 months), dexpramipexole-treated participants had reduced ALSFRS-R slope decline (p = 0.015), decreased mortality (p = 0.011), and reduced creatinine loss (p = 0.003). In conclusion, significant differences existed between the phase II and EMPOWER study populations in ALS clinical trials of dexpramipexole. In a post hoc analysis of EMPOWER subgroups defined by these differences, potential clinical benefits of dexpramipexole were identified in the subgroup of riluzole-treated, short-symptom duration, EEC-definite ALS participants. Creatinine loss correlated with disease progression and was reduced in dexpramipexole-treated participants, suggesting it as a candidate biomarker.

  19. Neuromuscular evaluation of post-orthodontic stability: an experimental protocol.

    PubMed

    Ferrario, Virgilio F; Marciandi, Paolo V; Tartaglia, Gianluca M; Dellavia, Claudia; Sforza, Chiarella

    2002-01-01

    To prevent relapse after orthodontic treatment, retention is often considered indispensable. Soft tissues are thought to have a significant influence on dental movements. To quantify the influence of masticatory muscles on post-treatment relapse, and in an attempt to avoid unnecessary procedures, 2 male orthodontic patients (13 and 30 years old at debonding) were followed up. The patients completed 2 years of fixed orthodontic treatment and received no post-orthodontic retention. After 1 week and again after 6 months, alginate impressions of dental arches and a surface electromyographic (EMG) assessment of the masseter and temporalis muscles during maximum voluntary clenching were performed. The younger patient received surface EMG monitoring once a month for the first 6 months and at the 1-year follow-up appointment. Arch dimensions and the 3-dimensional inclination of the facial axis of the clinical crown (FACC) were measured using a computerized digitizer. Symmetry in muscular contraction was measured by the percentage overlapping coefficient (POC), and potential lateral displacing components were assessed by the torque coefficient (TC). At the 6-month follow-up, no clinical modifications were observed. Quantitative evaluation assessed that arch dimensions had changed slightly (up to 1 mm). While the adolescent patient had no modifications in FACC inclinations, the 30-year-old patient showed significant alterations (up to 18 degrees). In all examinations of the adolescent patient, POC was higher than 86% and TC was lower than 10%. In the adult, POC was inside the normal range, while all TCs were higher than 10.5%. The larger TC measured in the adult may explain the larger modifications in the 3-dimensional position of his dental crowns. In conclusion, a surface EMG assessment may help in the detection of patients who might need post-orthodontic retention.

  20. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups

    PubMed Central

    Jafar, Tazeen H.; Jehan, Imtiaz; Liang, Feng; Barbier, Sylvaine; Islam, Muhammad; Bux, Rasool; Khan, Aamir Hameed; Nadkarni, Nivedita; Poulter, Neil; Chaturvedi, Nish; Ebrahim, Shah

    2015-01-01

    Background Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP) is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA) Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE) and trained general practitioner (GP) intervention delivered over 2 years was more effective than no intervention (usual care) in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up. Methods A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment) were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense) in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE) were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes. Findings After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1–0.1] mm Hg) compared to those randomised to usual care, (P = 0.04). Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl. Conclusions The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still

  1. Post-trial induction of conditioned apomorphine stimulant and inhibitory response effects: evidence for potent trace conditioning of drug effects.

    PubMed

    Santos, Breno Garone; Carey, Robert J; Carrera, Marinete Pinheiro

    2015-02-01

    The Pavlovian conditioning of drug effects has frequently been demonstrated using protocols that are variants of Pavlovian delay conditioning. We undertook to determine if drug conditioning could be induced using a Pavlovian trace conditioning procedure. Rats were tested in a novel open-field environment for 5 min and in post-trial phase were injected either with vehicle, 2.0 mg/kg or 0.05 mg/kg apomorphine immediately or after a delay of 15 min. The procedure was repeated three times and subsequently a 30 min non-drug test was given. The vehicle and 15 min post-trial apomorphine groups did not differ and in the 30 min test their locomotion scores were equivalent to another vehicle group tested for the first time. The group that received 2.0 mg/kg apomorphine immediately post-trial had a progressive increase in activity over the three sessions and also initially in the 30 min test. The results for the 0.05 mg/kg immediate post-test group were a mirror image of the 2.0 mg/kg apomorphine group. Post-trial apomorphine treatments can induce potent conditioned effects indicative of the efficacy of trace conditioning of drug effects. These finding suggest that trace conditioning may be an important contributor to the potency of conditioned-drug effects in the development of drug addiction.

  2. Evaluation of post-mortem oxymetry in fire victims.

    PubMed

    Maeda, H; Fukita, K; Oritani, S; Nagai, K; Zhu, B L

    1996-08-15

    In order to investigate the pathophysiology of death due to fires, we examined blood samples of 48 fire victims on CO-oximeter systems and evaluated the oxymetric differences between arterial and venous blood as well as those between the heart and peripheral blood. Post-mortem carboxyhemoglobin (CO-Hb) levels in the left and right heart blood, respectively, ranged from 1.2 to 94.7% and from 0.4 to 90.5%. Marked arterio-venous and centro-peripheral differences were observed in the cases of high CO-Hb (above ca. 70%), suggesting an immediate effect of fatal carbon monoxide (CO) poisoning probably accompanied with acute heart failure. A relatively high oxyhemoglobin level was observed in the cases of low CO-Hb (below ca. 30%). In some cases, reduced hemoglobin levels in the left heart blood were paradoxically somewhat higher than those in the right. These oxymetric profiles may assist to consider the final balance of blood gas in fire victims depending on increased CO, carbon dioxide, and reduction of oxygen in the ambient atmosphere due to combustion, although post-mortem interference should be taken into consideration.

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

    DTIC Science & Technology

    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

  4. Does pre- and post-angioplasty Doppler ultrasound evaluation help in predicting vascular access outcome?

    PubMed

    Guedes-Marques, Maria; Maia, Pedro A; Neves, Fernando; Ferreira, Aníbal; Cruz, João; Carvalho, Dulce; Oliveira, Carlos; Barreto, Carlos; Carvalho, Telmo; Ponce, Pedro

    2016-11-02

    Kidney Disease - Improving Global Outcomes (KDIGO) recommends post-percutaneous transluminal angioplasty (PTA) <30% residual stenosis (RS) and hemodynamic parameters improvement. Primary end point: how post-PTA access blood flow (ABF) improvement predicts vascular access (VA) outcome. Secondary: compare Doppler ultrasound (DU) and angiography diagnostic accuracy; determine how other factors predict outcome. Eighty patients. DU evaluation performed pre- and post-PTA. Several parameters recorded. Secondary patency verified after 6 months. Initial ABF 537 ± 248 mL/min; final ABF 1013 ± 354 mL/min. Number and location of stenosis was highly correlated between DU and angiography (p<0.001); central vessels mismatching. First semester overall survival was 63%; significantly better for fistulas (76%) than grafts (51.7%), p 0.044. Final RS>30% associated to better survival, p 0.038. Initial ABF<500 mL/min and multiple stenosis did not affect outcome (p>0.05). A >2-fold ABF increase had no significant impact on fistulas (p>0.05) but was significantly associated with worst outcomes in grafts (23.1% vs. 73.5%, p 0.009). Grafts had lower survival (HR 3.3, p 0.034). Although less accurate for central lesions, DU has a key role on VA surveillance, allowing a morphologic and hemodynamic assessment. Angioplasty is effective in preserving VA; however, it may increase restenosis due to accelerated neointimal hyperplasia. Current parameters are not useful. Trials addressing this issue are needed.

  5. Trial-Based Economic Evaluations in Occupational Health

    PubMed Central

    van Wier, Marieke F.; Tompa, Emile; Bongers, Paulien M.; van der Beek, Allard J.; van Tulder, Maurits W.; Bosmans, Judith E.

    2014-01-01

    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. PMID:24854249

  6. Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial.

    PubMed

    Seo, Han Gil; Paik, Nam-Jong; Lee, Shi-Uk; Oh, Byung-Mo; Chun, Min Ho; Kwon, Bum Sun; Bang, Moon Suk

    2015-01-01

    Botulinum toxin type A is widely used for treating spasticity. Neuronox (Neu-BoNT/A), a newly manufactured botulinum toxin a, has not yet been investigated for its efficacy and safety in the treatment of post-stroke upper limb spasticity. We evaluated the efficacy and safety of Neuronox (Neu-BoNT/A) compared with BOTOX (onabotulinum toxin A) for treating post-stroke upper limb spasticity. In total, 196 stroke patients with moderate to severe upper limb spasticity were randomly assigned to either Neuronox or BOTOX intervention. The wrist flexors were mandatory and elbow, finger, and thumb flexors were optional muscles to be injected. Assessments were performed at baseline and 4, 8, and 12 weeks after the intervention. The primary outcome measure was the change from baseline of the Modified Ashworth Scale (MAS) at the wrist flexors at week 4. Secondary outcome measures included the change of MAS at each visit, response rate, Disability Assessment Scale (DAS), Carer Burden Scale, and Global Assessment of treatment benefit. Primary outcome measures were -1.39±0.79 and -1.56±0.81 in the Neuronox and BOTOX groups, respectively. The difference was within the noninferiority margin of 0.45 (95% upper limit=0.40). There were no significant differences between the groups in the secondary outcome and safety measures, except the change of the MAS at the elbow flexors at week 12 (-0.88±0.75 in the Neuronox group, -0.65±0.74 in the BOTOX group; P=0.0429). Both groups showed significant improvements in the MAS, DAS, and Carer Burden Scale at weeks 4, 8, and 12. Neuronox showed equivalent efficacy and safety compared with BOTOX for treating post-stroke upper limb spasticity. ClinicalTrials.gov NCT01313767.

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

    PubMed Central

    Faiz, Seyed Hamid Reza; Rahimzadeh, Poupak; Poornajafian, Alireza; Nikzad, Naghme

    2014-01-01

    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. PMID:25371873

  8. Effectiveness and safety of Chinese massage therapy (Tui Na) on post-stroke spasticity: a prospective multicenter randomized controlled trial.

    PubMed

    Yang, Yu-Jie; Zhang, Jun; Hou, Ying; Jiang, Bao-Yin; Pan, Hua-Fei; Wang, Jian; Zhong, Da-Yong; Guo, Hai-Ying; Zhu, Yi; Cheng, Jie

    2017-07-01

    To evaluate the effectiveness and safety of Chinese massage therapy (Tui Na) for patients with post-stroke spasticity. A prospective, multicenter, blinded, randomized, placebo-controlled intervention trial. A total of 90 patients with post-stroke spasticity were randomly assigned to the experimental (Tui Na therapy) group ( n = 45) or control (placebo Tui Na therapy) group ( n = 45). Participants in the experimental group received Tui Na therapy, while those in the control group received placebo-Tai Na (gentle rubbing) for 20-25 minutes per limb, once per day, five days per week for a total of four weeks. All participants in both groups received conventional rehabilitation. The Modified Ashworth Scale, the Fugl-Meyer Assessment and the Modified Barthel Index were used to assess the severity of spasticity, motor function of limbs and activities of daily living, respectively. Assessments were performed at baseline, at four weeks and at three months. Tui Na group had a significantly greater reduction in Modified Ashworth Scale in only four muscle groups than the control did (elbow flexors, P = 0.026; wrist flexors, P = 0.005; knee flexors, P = 0.023; knee extensors, P = 0.017). Improvements were sustained at three months follow-up. There was no significant difference between the two groups in Fugl-Meyer Assessment ( P = 0.503) and Modified Barthel Index ( P = 0.544). No adverse reaction was recorded in any of the cases mentioned at all study sites. Tui Na might be a safe and effective treatment to reduce post-stroke spasticity of several muscle groups.

  9. Frequentist evaluation of group sequential clinical trial designs.

    PubMed

    Emerson, Scott S; Kittelson, John M; Gillen, Daniel L

    2007-12-10

    Group sequential stopping rules are often used as guidelines in the monitoring of clinical trials in order to address the ethical and efficiency issues inherent in human testing of a new treatment or preventive agent for disease. Such stopping rules have been proposed based on a variety of different criteria, both scientific (e.g. estimates of treatment effect) and statistical (e.g. frequentist type I error, Bayesian posterior probabilities, stochastic curtailment). It is easily shown, however, that a stopping rule based on one of these criteria induces a stopping rule on all other criteria. Thus, the basis used to initially define a stopping rule is relatively unimportant so long as the operating characteristics of the stopping rule are fully investigated. In this paper we describe how the frequentist operating characteristics of a particular stopping rule might be evaluated to ensure that the selected clinical trial design satisfies the constraints imposed by the many different disciplines represented by the clinical trial collaborators.

  10. A prospective randomized trial of lafutidine vs rabeprazole on post-ESD gastric ulcers

    PubMed Central

    Ohya, Tomohiko Richard; Endo, Hiroki; Kawagoe, Kei; Yanagawa, Tatsuro; Hanawa, Katsuhiro; Ohata, Ken; Asayama, Masako; Hisatomi, Kantaro; Teratani, Takuma; Gunji, Toshiaki; Sato, Hajime; Matsuhashi, Nobuyuki

    2010-01-01

    AIM: To compare the effects of rabeprazole and lafutidine on post-endoscopic submucosal dissection (ESD) gastric ulcers. METHODS: Patients with gastric tumors indicated for ESD were prospectively studied. After ESD, all patients were treated with intravenous omeprazole for the first 3 d. Patients were then randomly assigned to oral lafutidine or rabeprazole. Ulcer size, ulcer size reduction rate, and ulcer stage were evaluated 4 wk later. Occurrence of complication was monitored throughout the 4-wk period. RESULTS: Sixty five patients were enrolled in the study, and 60 patients were subjected to the final analysis. In the lafutidine group (30 lesions in 29 patients), initial and 4-wk post-ESD ulcer sizes were 33.3 ± 9.2 and 10.5 ± 4.8 mm, respectively. In the rabeprazole group (34 lesions in 31 patients), the values were 34.7 ± 11.3 and 11.8 ± 6.7 mm, respectively. Ulcer size reduction rates in lafutidine and rabeprazole groups were 32.3% and 33.5%, respectively (P = 0.974). Ulcer stage 4 wk post-ESD did not differ significantly between the two groups (P = 0.868). Two cases in the rabeprazole group and no cases in the lafutidine group developed ulcer bleeding during the oral dose period, although the difference of bleeding rate between the two groups was not statistically significant (P = 0.157). CONCLUSION: Lafutidine and rabeprazole have equivalent therapeutic effects on post-ESD gastric ulcers. PMID:21160677

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

    PubMed Central

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

    2008-01-01

    Aims This study examined the effectiveness of methadone maintenance initiated prior to or just after release from prison at 6 months post-release. Design A three-group randomized controlled trial was conducted between September 2003 and June 2005. Setting A Baltimore pre-release prison. Participants Two hundred and eleven adult pre-release inmates who were heroin-dependent during the year prior to incarceration. Intervention 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). Measurements 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. Findings 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 participants (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. Conclusions 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. PMID:18855822

  12. A randomised controlled trial of post-operative rehabilitation after surgical decompression of the lumbar spine

    PubMed Central

    Denzler, Raymond; Dvorak, Jiri; Müntener, Markus; Grob, Dieter

    2007-01-01

    Spinal decompression is the most common type of spinal surgery carried out in the older patient, and is being performed with increasing frequency. Physiotherapy (rehabilitation) is often prescribed after surgery, although its benefits compared with no formal rehabilitation have yet to be demonstrated in randomised control trials. The aim of this randomised controlled trial was to examine the effects on outcome up to 2 years after spinal decompression surgery of two types of postoperative physiotherapy compared with no postoperative therapy (self-management). Hundred and fifty-nine patients (100 men, 59 women; 65 ± 11 years) undergoing decompression surgery for spinal stenosis/herniated disc were randomised to one of the following programmes beginning 2 months post-op: recommended to “keep active” (CONTROL; n = 54); physiotherapy, spine stabilisation exercises (PT-StabEx; n = 56); physiotherapy, mixed techniques (PT-Mixed; n = 49). Both PT programmes involved 2 × 30 min sessions/week for up to 12 weeks, with home exercises. Pain intensity (0–10 graphic rating scale, for back and leg pain separately) and self-rated disability (Roland Morris) were assessed before surgery, before and after the rehabilitation phase (approx. 2 and 5 months post-op), and at 12 and 24 months after the operation. ‘Intention to treat’ analyses were used. At 24 months, 151 patients returned questionnaires (effective return rate, excluding 4 deaths, 97%). Significant reductions in leg and back pain and self-rated disability were recorded after surgery (P < 0.05). Pain showed no further changes in any group up to 24 months later, whereas disability declined further during the “rehabilitation” phase (P < 0.05) then stabilised, but with no significant group differences. 12 weeks of post-operative physiotherapy did not influence the course of change in pain or disability up to 24 months after decompression surgery. Advising patients to keep active by

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

    PubMed

    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

  14. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups.

    PubMed

    Jafar, Tazeen H; Jehan, Imtiaz; Liang, Feng; Barbier, Sylvaine; Islam, Muhammad; Bux, Rasool; Khan, Aamir Hameed; Nadkarni, Nivedita; Poulter, Neil; Chaturvedi, Nish; Ebrahim, Shah

    2015-01-01

    Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP) is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA) Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE) and trained general practitioner (GP) intervention delivered over 2 years was more effective than no intervention (usual care) in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up. A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment) were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense) in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE) were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes. After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1-0.1] mm Hg) compared to those randomised to usual care, (P = 0.04). Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl. The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still evident at 7- year follow-up. These findings

  15. A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches

    DTIC Science & Technology

    2011-12-01

    double-blinded, placebo-controlled clinical trial was conducted to evaluate the effectiveness of propranolol , topiramate, and amitriptyline as...16.7 to 8.7 in the placebo arm (-48%, p=0.012), 11.7 to 6.1 in the amitriptyline arm (-41%, p=0.0005), 14.0 to 8.3 in the propranolol arm (-41%, p=0.10...p=0.0001) and significantly declined in the placebo, topiramate, and propranolol arms. There were no significant differences between placebo and

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

    PubMed

    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.

  17. TELEPHONE-DELIVERED COLLABORATIVE-CARE FOR TREATING POST-CABG DEPRESSION: A RANDOMIZED CONTROLLED TRIAL

    PubMed Central

    Rollman, Bruce L.; Belnap, Bea Herbeck; LeMenager, Michelle S.; Mazumdar, Sati; Houck, Patricia R.; Counihan, Peter J.; Kapoor, Wishwa N.; Schulberg, Herbert C.; Reynolds, Charles F.

    2010-01-01

    Context Depressive symptoms commonly follow coronary artery bypass (CABG) surgery and are associated with worse clinical outcomes. Objective To test the effectiveness of telephone-delivered collaborative care for post-CABG depression versus doctors’ usual care. Design Single-blind effectiveness trial. Setting Seven Pittsburgh-area university-based and community hospitals. Participants 302 depressed post-CABG patients and a non-depressed comparison group of 151 randomly sampled post-CABG patients recruited between 3/2004 and 9/2007 and followed as outpatients. Intervention 8-Months of telephone-delivered collaborative care provided by nurses working with patients’ primary care physicians and supervised by a study psychiatrist and study primary care physician. Main Outcome Measures Mental health-related quality of life (HRQoL) as measured by the SF-36 MCS at 8-months follow-up; secondary outcome measures included mood symptoms (Hamilton Rating Scale for Depression (HRS-D)), physical HRQoL (SF-36 PCS) and functioning (Duke Activity Status Index (DASI)); and hospital readmissions. Results Depressed intervention patients (N=150) reported greater improvements (all P ≤ 0.02) in mental HRQoL (SF-36 MCS: Δ 3.2 points; 95% CI: 0.5–6.0), physical functioning (DASI: Δ 4.6 points; 1.9–7.3), and mood symptoms (HRS-D: Δ3.1 points (1.3–4.9); and were more likely to report a ≥ 50% decline in HRS-D score from baseline (50.0% vs. 29.6%; NNT 4.9 (3.2–10.4)) than depressed patients randomized to their physicians’ usual care (N=152) (P<0.001). Depressed men were particularly likely to benefit from the intervention (SF-36 MCS: Δ 5.7 points (2.2–9.2); P=0.001) and tended to have a lower incidence of rehospitalization for cardiovascular causes than depressed men receiving usual care (13% vs. 23%; P=0.07) or depressed women (19% vs. 11%; P=0.22). However, the mean HRQoL and physical functioning of depressed intervention patients did not reach that of our non

  18. Evaluation of post-surface conditioning to improve interfacial adhesion in post-core restorations.

    PubMed

    Sumitha, Mylswamy; Kothandaraman, Rajkumar; Sekar, Mahalaxmi

    2011-01-01

    To examine the influence of different post-surface treatments on the interfacial strength between epoxy resin-based fiber posts and methacrylate-based resin composites that are employed as core build-up materials. Forty clear posts were divided into four groups of 10 each. The different surface treatments used were etching with alkaline potassium permanganate, 10% hydrogen peroxide, 37% phosphoric acid, and silanization alone. After etching and thorough rinsing, a single layer of silane was applied to the post surface. Then the post was placed in a rectangular plastic matrix and core bulid-up was done using Multi Core, a dual cured composite resin. A slab of uniform thickness, with the post in the center and the core build-up composite on either side was created. The specimens were cut so as to obtain microtensile sticks that were loaded in tension at a cross-head speed of 1 mm/min until failure. The statistical analysis was performed using two-way ANOVA and the paired T test for post-hoc comparisons. The results achieved with potassium permanganate had a significant influence on microtensile interfacial bond strength values with the tested material. Surface chemical treatments of the resin phase of fiber posts enhance the silanization efficiency of the quartz fiber phase, so that the adhesion in the post/core unit may be considered as a net sum of chemical and micromechanical retention.

  19. Ebola Virus Disease Candidate Vaccines Under Evaluation in Clinical Trials

    PubMed Central

    Martins, Karen A.; Jahrling, Peter B.; Bavari, Sina; Kuhn, Jens H.

    2016-01-01

    Summary Filoviruses are the etiological agents of two human illnesses: Ebola virus disease and Marburg virus disease. Until 2013, medical countermeasure development against these afflictions was limited to only a few research institutes worldwide as both infections were considered exotic due to very low case numbers. Together with the high case-fatality rate of both diseases, evaluation of any candidate countermeasure in properly controlled clinical trials seemed impossible. However, in 2013, Ebola virus was identified as the etiological agent of a large disease outbreak in Western Africa including almost 30,000 infections and more than 11,000 deaths, including case exportations to Europe and North America. These large case numbers resulted in medical countermeasure development against Ebola virus disease becoming a global public-health priority. This review summarizes the status quo of candidate vaccines against Ebola virus disease, with a focus on those that are currently under evaluation in clinical trials. PMID:27160784

  20. Analyzing SNOMED CT and HL7 terminology binding for semantic interoperability on post-genomic clinical trials.

    PubMed

    Aso, Santiago; Perez-Rey, David; Alonso-Calvo, Raul; Rico-Diez, Antonio; Bucur, Anca; Claerhout, Brecht; Maojo, Victor

    2013-01-01

    Current post-genomic clinical trials in cancer involve the collaboration of several institutions. Multi-centric retrospective analysis requires advanced methods to ensure semantic interoperability. In this scenario, the objective of the EU funded INTEGRATE project, is to provide an infrastructure to share knowledge and data in post-genomic breast cancer clinical trials. This paper presents the process carried out in this project, to bind domain terminologies in the area, such as SNOMED CT, with the HL7 v3 Reference Information Model (RIM). The proposed terminology binding follow the HL7 recommendations, but should also consider important issues such as overlapping concepts and domain terminology coverage. Although there are limitations due to the large heterogeneity of the data in the area, the proposed process has been successfully applied within the context of the INTEGRATE project. An improvement in semantic interoperability of patient data from modern breast cancer clinical trials, aims to enhance the clinical practice in oncology.

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

    PubMed Central

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

    2015-01-01

    Background Few studies have documented the possibility of treatment-induced improvements in language functions 12 months or longer after stroke. The purpose of the current study was 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 provide the data needed to design an appropriately powered trial. Material/Methods This was a randomized, controlled, single-blinded, pilot trial. We identified 32 patients with chronic post-stroke aphasia. Of these, 27 were offered participation, and 24 were randomized (CONSORT diagram): 14 to CIAT and to 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours of 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)). To maintain blinding, clinicians treating patients (CIAT group) did not communicate with other team members and the testing team members were blinded to treatment group assignment. Results Overall, the results of this pilot trial 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. Conclusions In this randomized, controlled, and blinded pilot study, intensive language therapy (CIAT) 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

  2. Efficacy of Losartan in the management of Post-Dialysis Euvolemic Hypertension (HELD-Trial): A Single-Blind Randomized Control Trial.

    PubMed

    Aftab, Raja Ahsan; Khan, Amer Hayat; Adnan, Azreen Syazril; Sulaiman, Syed Azhar Syed; Khan, Tahir Mehmood

    2016-12-06

    To assess the effectiveness of losartan 50 mg on post dialysis euvolemic hypertensive patients against standard antihypertensive pharmacotherapy. A multicentre, prospective, randomized, single-blind trial was conducted to assess the effect of losartan 50 mg every other day (EOD), once a morning (OM) among post-dialysis euvolemic hypertensive patients. Covariate-adaptive randomization was used to allocate participants to a standard or treatment arm, and they were followed up for eight weeks. Pre-, intra- and post-dialysis session blood pressure (BP) measurements were recorded along with any adverse events. A total of 88 patients were randomized into standard (n = 44) and treatment arms (n = 44) and were followed for a period of 8 weeks. In the standard group, the mean post-dialysis blood pressure dropped by 0.3 mmHg by the end of the 8(th) week. However the treatment arm reported a drop of 2.4 mmHg of BP drop during the 8-week trial period. Analysis suggests that there was a significant difference in blood pressure readings at the end of 8 weeks among patients treated with losartan (P < 0.001). However, no such statistical association was observed in the standard arm (P 0.75). A slow, steady significant decline in post-dialysis BP was observed among euvolemic hypertensive patients that were treated with losartan 50 mg.

  3. Efficacy of Losartan in the management of Post-Dialysis Euvolemic Hypertension (HELD-Trial): A Single-Blind Randomized Control Trial

    PubMed Central

    Aftab, Raja Ahsan; Khan, Amer Hayat; Adnan, Azreen Syazril; Sulaiman, Syed Azhar Syed; Khan, Tahir Mehmood

    2016-01-01

    To assess the effectiveness of losartan 50 mg on post dialysis euvolemic hypertensive patients against standard antihypertensive pharmacotherapy. A multicentre, prospective, randomized, single-blind trial was conducted to assess the effect of losartan 50 mg every other day (EOD), once a morning (OM) among post-dialysis euvolemic hypertensive patients. Covariate-adaptive randomization was used to allocate participants to a standard or treatment arm, and they were followed up for eight weeks. Pre-, intra- and post-dialysis session blood pressure (BP) measurements were recorded along with any adverse events. A total of 88 patients were randomized into standard (n = 44) and treatment arms (n = 44) and were followed for a period of 8 weeks. In the standard group, the mean post-dialysis blood pressure dropped by 0.3 mmHg by the end of the 8th week. However the treatment arm reported a drop of 2.4 mmHg of BP drop during the 8-week trial period. Analysis suggests that there was a significant difference in blood pressure readings at the end of 8 weeks among patients treated with losartan (P < 0.001). However, no such statistical association was observed in the standard arm (P 0.75). A slow, steady significant decline in post-dialysis BP was observed among euvolemic hypertensive patients that were treated with losartan 50 mg. PMID:27922020

  4. Randomized Trial of a Delirium Abatement Program for Post-acute Skilled Nursing Facilities

    PubMed Central

    Marcantonio, Edward R.; Bergmann, Margaret A.; Kiely, Dan K.; Orav, E John; Jones, Richard N.

    2010-01-01

    Objectives To determine whether a Delirium Abatement Program (DAP) can shorten the duration of delirium among new admissions to post-acute care (PAC). Design Cluster randomized controlled trial. Setting Eight skilled nursing facilities specializing in PAC within a single metropolitan region. Participants Four hundred fifty-seven participants with delirium at PAC admission. Intervention The DAP consisted of four steps: 1) assessment for delirium within 5 days of PAC admission, 2) assessment and correction of common reversible causes of delirium, 3) prevention of complications of delirium, and 4) restoration of function. Measurements Eligible patients were screened by trained researchers. Those with Confusion Assessment Method defined delirium were eligible for participation via proxy consent. Two weeks and one month after enrollment, regardless of location, participants were re-assessed for delirium by researchers blind to intervention status. Results Nurses at DAP sites detected delirium in 41% of participants vs. 12% in usual care (UC) sites (p<.001) and completed DAP documentation in most delirium-detected participants. However, the DAP intervention had no impact on delirium persistence based on two measurements at 2 weeks (DAP 68% vs. UC 66%) and 1 month (DAP 60% vs. UC 51%), adjusted p values ≥ 0.20. Adjusting for baseline differences between DAP and UC participants and restricting analysis to delirium-detected DAP participants did not alter the results. Conclusion Detection of delirium improved at the DAP sites, however, the DAP had no impact on the persistence of delirium. This effectiveness trial demonstrated that a nurse-led DAP intervention was not effective in typical PAC facilities. PMID:20487083

  5. Evaluating biomarkers to model cancer risk post cosmic ray exposure.

    PubMed

    Sridharan, Deepa M; Asaithamby, Aroumougame; Blattnig, Steve R; Costes, Sylvain V; Doetsch, Paul W; Dynan, William S; Hahnfeldt, Philip; Hlatky, Lynn; Kidane, Yared; Kronenberg, Amy; Naidu, Mamta D; Peterson, Leif E; Plante, Ianik; Ponomarev, Artem L; Saha, Janapriya; Snijders, Antoine M; Srinivasan, Kalayarasan; Tang, Jonathan; Werner, Erica; Pluth, Janice M

    2016-06-01

    Robust predictive models are essential to manage the risk of radiation-induced carcinogenesis. Chronic exposure to cosmic rays in the context of the complex deep space environment may place astronauts at high cancer risk. To estimate this risk, it is critical to understand how radiation-induced cellular stress impacts cell fate decisions and how this in turn alters the risk of carcinogenesis. Exposure to the heavy ion component of cosmic rays triggers a multitude of cellular changes, depending on the rate of exposure, the type of damage incurred and individual susceptibility. Heterogeneity in dose, dose rate, radiation quality, energy and particle flux contribute to the complexity of risk assessment. To unravel the impact of each of these factors, it is critical to identify sensitive biomarkers that can serve as inputs for robust modeling of individual risk of cancer or other long-term health consequences of exposure. Limitations in sensitivity of biomarkers to dose and dose rate, and the complexity of longitudinal monitoring, are some of the factors that increase uncertainties in the output from risk prediction models. Here, we critically evaluate candidate early and late biomarkers of radiation exposure and discuss their usefulness in predicting cell fate decisions. Some of the biomarkers we have reviewed include complex clustered DNA damage, persistent DNA repair foci, reactive oxygen species, chromosome aberrations and inflammation. Other biomarkers discussed, often assayed for at longer points post exposure, include mutations, chromosome aberrations, reactive oxygen species and telomere length changes. We discuss the relationship of biomarkers to different potential cell fates, including proliferation, apoptosis, senescence, and loss of stemness, which can propagate genomic instability and alter tissue composition and the underlying mRNA signatures that contribute to cell fate decisions. Our goal is to highlight factors that are important in choosing

  6. Evaluating biomarkers to model cancer risk post cosmic ray exposure

    NASA Astrophysics Data System (ADS)

    Sridharan, Deepa M.; Asaithamby, Aroumougame; Blattnig, Steve R.; Costes, Sylvain V.; Doetsch, Paul W.; Dynan, William S.; Hahnfeldt, Philip; Hlatky, Lynn; Kidane, Yared; Kronenberg, Amy; Naidu, Mamta D.; Peterson, Leif E.; Plante, Ianik; Ponomarev, Artem L.; Saha, Janapriya; Snijders, Antoine M.; Srinivasan, Kalayarasan; Tang, Jonathan; Werner, Erica; Pluth, Janice M.

    2016-06-01

    Robust predictive models are essential to manage the risk of radiation-induced carcinogenesis. Chronic exposure to cosmic rays in the context of the complex deep space environment may place astronauts at high cancer risk. To estimate this risk, it is critical to understand how radiation-induced cellular stress impacts cell fate decisions and how this in turn alters the risk of carcinogenesis. Exposure to the heavy ion component of cosmic rays triggers a multitude of cellular changes, depending on the rate of exposure, the type of damage incurred and individual susceptibility. Heterogeneity in dose, dose rate, radiation quality, energy and particle flux contribute to the complexity of risk assessment. To unravel the impact of each of these factors, it is critical to identify sensitive biomarkers that can serve as inputs for robust modeling of individual risk of cancer or other long-term health consequences of exposure. Limitations in sensitivity of biomarkers to dose and dose rate, and the complexity of longitudinal monitoring, are some of the factors that increase uncertainties in the output from risk prediction models. Here, we critically evaluate candidate early and late biomarkers of radiation exposure and discuss their usefulness in predicting cell fate decisions. Some of the biomarkers we have reviewed include complex clustered DNA damage, persistent DNA repair foci, reactive oxygen species, chromosome aberrations and inflammation. Other biomarkers discussed, often assayed for at longer points post exposure, include mutations, chromosome aberrations, reactive oxygen species and telomere length changes. We discuss the relationship of biomarkers to different potential cell fates, including proliferation, apoptosis, senescence, and loss of stemness, which can propagate genomic instability and alter tissue composition and the underlying mRNA signatures that contribute to cell fate decisions. Our goal is to highlight factors that are important in choosing

  7. Evaluating biomarkers to model cancer risk post cosmic ray exposure

    PubMed Central

    Sridhara, Deepa M.; Asaithamby, Aroumougame; Blattnig, Steve R.; Costes, Sylvain V.; Doetsch, Paul W.; Dynan, William S.; Hahnfeldt, Philip; Hlatky, Lynn; Kidane, Yared; Kronenberg, Amy; Naidu, Mamta D.; Peterson, Leif E.; Plante, Ianik; Ponomarev, Artem L.; Saha, Janapriya; Snijders, Antoine M.; Srinivasan, Kalayarasan; Tang, Jonathan; Werner, Erica; Pluth, Janice M.

    2017-01-01

    Robust predictive models are essential to manage the risk of radiation-induced carcinogenesis. Chronic exposure to cosmic rays in the context of the complex deep space environment may place astronauts at high cancer risk. To estimate this risk, it is critical to understand how radiation-induced cellular stress impacts cell fate decisions and how this in turn alters the risk of carcinogenesis. Exposure to the heavy ion component of cosmic rays triggers a multitude of cellular changes, depending on the rate of exposure, the type of damage incurred and individual susceptibility. Heterogeneity in dose, dose rate, radiation quality, energy and particle flux contribute to the complexity of risk assessment. To unravel the impact of each of these factors, it is critical to identify sensitive biomarkers that can serve as inputs for robust modeling of individual risk of cancer or other long-term health consequences of exposure. Limitations in sensitivity of biomarkers to dose and dose rate, and the complexity of longitudinal monitoring, are some of the factors that increase uncertainties in the output from risk prediction models. Here, we critically evaluate candidate early and late biomarkers of radiation exposure and discuss their usefulness in predicting cell fate decisions. Some of the biomarkers we have reviewed include complex clustered DNA damage, persistent DNA repair foci, reactive oxygen species, chromosome aberrations and inflammation. Other biomarkers discussed, often assayed for at longer points post exposure, include mutations, chromosome aberrations, reactive oxygen species and telomere length changes. We discuss the relationship of biomarkers to different potential cell fates, including proliferation, apoptosis, senescence, and loss of stemness, which can propagate genomic instability and alter tissue composition and the underlying mRNA signatures that contribute to cell fate decisions. Our goal is to highlight factors that are important in choosing

  8. Evaluation of sex, race, body mass index and pre-vaccination serum progesterone levels and post-vaccination serum anti-anthrax protective immunoglobulin G on injection site adverse events following anthrax vaccine adsorbed (AVA) in the CDC AVA human clinical trial.

    PubMed

    Pondo, Tracy; Rose, Charles E; Martin, Stacey W; Keitel, Wendy A; Keyserling, Harry L; Babcock, Janiine; Parker, Scott; Jacobson, Robert M; Poland, Gregory A; McNeil, Michael M

    2014-06-12

    Anthrax vaccine adsorbed (AVA) administered intramuscularly (IM) results in fewer adverse events (AEs) than subcutaneous (SQ) administration. Women experience more AEs than men. Antibody response, female hormones, race, and body mass index (BMI) may contribute to increased frequency of reported injection site AEs. We analyzed data from the CDC AVA human clinical trial. This double blind, randomized, placebo controlled trial enrolled 1563 participants and followed them through 8 injections (AVA or placebo) over a period of 42 months. For the trial's vaccinated cohort (n=1267), we used multivariable logistic regression to model the effects of study group (SQ or IM), sex, race, study site, BMI, age, and post-vaccination serum anti-PA IgG on occurrence of AEs of any severity grade. Also, in a women-only subset (n=227), we assessed effect of pre-vaccination serum progesterone level and menstrual phase on AEs. Participants who received SQ injections had significantly higher proportions of itching, redness, swelling, tenderness and warmth compared to the IM study group after adjusting for other risk factors. The proportions of redness, swelling, tenderness and warmth were all significantly lower in blacks vs. non-black participants. We found arm motion limitation, itching, pain, swelling and tenderness were more likely to occur in participants with the highest anti-PA IgG concentrations. In the SQ study group, redness and swelling were more common for obese participants compared to participants who were not overweight. Females had significantly higher proportions of all AEs compared to males. Menstrual phase was not associated with any AEs. Female and non-black participants had a higher proportion of AVA associated AEs and higher anti-PA IgG concentrations. Antibody responses to other vaccines may also vary by sex and race. Further studies may provide better understanding for higher proportions of AEs in women and non-black participants. Published by Elsevier Ltd.

  9. Comparison of indomethacin suppository and lidocaine cream on post-episiotomy pain: A randomized trial

    PubMed Central

    Delaram, Masoumeh; Dadkhah, Narges-Khaton; Jafarzadeh, Loabat

    2015-01-01

    Background: One of the most important problems after episiotomy is perineal pain which is more severe on the first day of postpartum period. The aim of this study was to compare the analgesic effects of indomethacin suppository and lidocaine cream in the management of post-episiotomy pain. Materials and Methods: In a randomized, controlled trial, 60 primiparous women who had mediolateral episiotomy received 50 mg indomethacin suppository (n = 30) or 2% lidocaine cream (n = 30) in the postpartum period in Hajar Hospital in Shahrekord (Iran). The mean severity of post-episiotomy pain was assessed with the first complaint and at 6, 12, and 24 h after the delivery, and compared in the two groups. The visual analog scale (VAS) was used for pain recording and data were analyzed with independent-samples t-test, χ2, and Fisher's exact tests, and significance was defined as P < 0.05. Results: With the first complaint of pain, the mean intensity of pain was 4.9 (1.9) in the indomethacin group and 4.9 (1.8) in the lidocaine group, and the difference was not significant (P = 0.25). Six hours after birth, it was 3.3 (1.3) in the indomethacin group and 3.2 (1.9) in the lidocaine group, and there was not a significant difference between the two groups (P = 0.90). No significant difference was found between the two groups at 12 h after birth [2.3 (1.7) vs 2.5 (1.7); P = 0.59]. Also, the difference was not significant at 24 h after birth [1.5 (1.3) vs 1.8 (1.3); P = 0.31]. Conclusions: It was concluded from the study that indomethacin suppository and lidocaine cream have similar efficacy on episiotomy pain relief on the first day of postpartum period. PMID:26257799

  10. The effect of magnesium supplements on early post-transplantation glucose metabolism: a randomized controlled trial.

    PubMed

    Van Laecke, Steven; Nagler, Evi Vanessa; Taes, Youri; Van Biesen, Wim; Peeters, Patrick; Vanholder, Raymond

    2014-09-01

    Post-transplantation hypomagnesemia is common and predicts diabetes. Magnesium improves glycemic control in diabetics and insulin sensitivity in insulin resistant subjects. We aimed to assess the effectiveness of oral magnesium for improving glycemic control and insulin sensitivity at 3 months post-transplantation. We conducted a single-center, open-label, randomized parallel group study. We included adults with serum magnesium <1.7 mg/dl within 2 weeks after kidney transplantation. We randomized participants to 450 mg magnesium oxide up to three times daily or no treatment. The primary endpoint was the mean difference in fasting glycemia. Secondary endpoints were the mean difference in area under the curve (AUC) of glucose during an oral glucose tolerance test and insulin resistance measured by Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR). Analyses were on intention-to-treat basis. In patients randomized to magnesium oxide (N = 27) versus no treatment (N = 27), fasting glycemia on average was 11.5 mg/dl lower (95% CI 1.7 to 21.3; P = 0.02). There was no difference between the two groups neither for 2 h AUC, where the mean value was 1164 mg/dl/min (95% CI -1884 to 4284; P = 0.45) lower in the treatment group nor for HOMA-IR. Magnesium supplements modestly improved fasting glycemia without effect on insulin resistance. Higher baseline glycemia among patients in the control group may have driven the positive outcome (ClinicalTrials.gov number: NCT01889576).

  11. Restricted Crystalloid Fluid Therapy during Orthotopic Liver Transplant Surgery and its Effect on Respiratory and Renal Insufficiency in the Early Post-operative Period: A Randomized Clinical Trial.

    PubMed

    Sahmeddini, M A; Janatmakan, F; Khosravi, M B; Ghaffaripour, S; Eghbal, M H; Nickeghbalian, S; Malek-Hosseini, S A

    2014-01-01

    Respiratory and renal insufficiencies are common dysfunctions during post-liver transplantation period that increase post-operative mortality and morbidity rates. Intra-operative fluid therapy is an important factor associated with pulmonary and renal insufficiency. To evaluate the relation between intra-operative fluid therapy and early renal and respiratory insufficiency after liver transplantation. In this randomized clinical study, 67 adult patients with end-stage liver disease who underwent orthotopic deceased donor liver transplantation were randomly allocated into two groups. The restricted fluid group, which received a controlled fluid administration of normal saline, 5 mL/kg/hr during anesthesia, and non-restricted fluid group received a controlled infusion of normal saline 10 mL/kg/hr during anesthesia. Early post-operative respiratory and renal insufficiency in both groups were assessed. The patients were monitored during the three stages of liver transplantation for their hemodynamic indices. The trial is registered with the Iranian Randomized Clinical Trial Registry, number IRCT2013101811662N4. The baseline demographic and clinical characteristics were similar in both studied groups. The prevalence of respiratory insufficiency in the non-restricted fluid group (15%) significantly (p=0.01) higher than that in the restricted fluid group (0%). The post-operative mean±SD serum creatinine was 1.0±0.1 mg/dL in the non-restricted fluid group and 1.1±0.2 in the restricted fluid group (p=0.43). No patients in the studied groups required post-operative continuous renal replacement therapy. Restricted crystalloid fluid administration during orthotropic liver transplantation though decreased post-operative chance of pulmonary insufficiency, did not increase renal dysfunction.

  12. Restricted Crystalloid Fluid Therapy during Orthotopic Liver Transplant Surgery and its Effect on Respiratory and Renal Insufficiency in the Early Post-operative Period: A Randomized Clinical Trial

    PubMed Central

    Sahmeddini, M. A.; Janatmakan, F.; Khosravi, M. B.; Ghaffaripour, S.; Eghbal, M. H.; Nickeghbalian, S.; Malek-Hosseini, S. A.

    2014-01-01

    Background: Respiratory and renal insufficiencies are common dysfunctions during post-liver transplantation period that increase post-operative mortality and morbidity rates. Intra-operative fluid therapy is an important factor associated with pulmonary and renal insufficiency. Objective: To evaluate the relation between intra-operative fluid therapy and early renal and respiratory insufficiency after liver transplantation. Methods: In this randomized clinical study, 67 adult patients with end-stage liver disease who underwent orthotopic deceased donor liver transplantation were randomly allocated into two groups. The restricted fluid group, which received a controlled fluid administration of normal saline, 5 mL/kg/hr during anesthesia, and non-restricted fluid group received a controlled infusion of normal saline 10 mL/kg/hr during anesthesia. Early post-operative respiratory and renal insufficiency in both groups were assessed. The patients were monitored during the three stages of liver transplantation for their hemodynamic indices. The trial is registered with the Iranian Randomized Clinical Trial Registry, number IRCT2013101811662N4. Results: The baseline demographic and clinical characteristics were similar in both studied groups. The prevalence of respiratory insufficiency in the non-restricted fluid group (15%) significantly (p=0.01) higher than that in the restricted fluid group (0%). The post-operative mean±SD serum creatinine was 1.0±0.1 mg/dL in the non-restricted fluid group and 1.1±0.2 in the restricted fluid group (p=0.43). No patients in the studied groups required post-operative continuous renal replacement therapy. Conclusions: Restricted crystalloid fluid administration during orthotropic liver transplantation though decreased post-operative chance of pulmonary insufficiency, did not increase renal dysfunction. PMID:25184031

  13. The Effectiveness of Prophylactic Antibiotics with Oral Levofloxacin against Post-Shock Wave Lithotripsy Infectious Complications: A Randomized Controlled Trial.

    PubMed

    Hsieh, Cheng-Hsing; Yang, Stephen Shei-Dei; Chang, Shang-Jen

    2016-06-01

    To evaluate the efficacy of prophylactic antibiotics in reduction of infections after shock wave lithotripsy (SWL) in patients undergoing shock wave lithotripsy (SWL). The study was a randomized control trial. Between 2012 and 2014, patients with pre-operative sterile urine undergoing SWL were randomly assigned by the randomization ratio of 1:1 to receive prophylactic antibiotics with single-dose oral levofloxacin (500 mg) or no treatment (control group), respectively. Urinalysis and urine cultures were obtained between post-operative day five and seven, respectively. Pyuria was defined as ≥10 white blood cells per high power field (WBC/hpf). Significant bacteriuria was defined as ≥10(5) colony forming units per milliliter (CFU/mL) uropathogens. Febrile urinary tract infection (fUTI) was defined as body temperature higher than 38.0°C with pyuria or significant bacteriuria within seven days after SWL treatment. Initially, 274 patents underwent randomization with 135 and 139 patients in the levofloxacin and control group, respectively. A total of 206 patients (106 with placebo and 100 with levofloxacin) with complete follow-up of urinalysis were eligible for analysis. The rates of post-operative pyuria were not significantly different in patients with and without prophylaxis (8% versus 4.7%, p = 0.33). Moreover, there was also no significant difference in rates of bacteriuria in patients with and without prophylaxis (1% versus 0%, p = 0.49). Patients without follow-up urinalysis and urine culture received telephone survey. Among them, there was only one patient reporting post-SWL fever in the levofloxacin group (0.7%) compared with none (0%) in the control group (p = 0.49). As the results of the interim analysis revealed no benefit of levofloxacin in preventing post-SWL pyuria, bacteriuria, and fUTI, we terminated the study early before the pre-planned sample size was achieved. The incidence of asymptomatic and fUTI is low in patients with pre

  14. Scapula alata in early breast cancer patients enrolled in a randomized clinical trial of post-surgery short-course image-guided radiotherapy

    PubMed Central

    2012-01-01

    Background Scapula alata (SA) is a known complication of breast surgery associated with palsy of the serratus anterior, but it is seldom mentioned. We evaluated the risk factors associated with SA and the relationship of SA with ipsilateral shoulder/arm morbidity in a series of patients enrolled in a trial of post-surgery radiotherapy (RT). Methods The trial randomized women with completely resected stage I-II breast cancer to short-course image-guided RT, versus conventional RT. SA, arm volume and shoulder-arm mobility were measured prior to RT and at one to three months post-RT. Shoulder/arm morbidities were computed as a post-RT percentage change relative to pre-RT measurements. Results Of 119 evaluable patients, 13 (= 10.9%) had pre-RT SA. Age younger than 50 years old, a body mass index less than 25 kg/m2, and axillary lymph node dissection were significant risk factors, with odds ratios of 4.8 (P = 0.009), 6.1 (P = 0.016), and 6.1 (P = 0.005), respectively. Randomization group was not significant. At one to three months’ post-RT, mean arm volume increased by 4.1% (P = 0.036) and abduction decreased by 8.6% (P = 0.046) among SA patients, but not among non-SA patients. SA resolved in eight, persisted in five, and appeared in one patient. Conclusion The relationship of SA with lower body mass index suggests that SA might have been underestimated in overweight patients. Despite apparent resolution of SA in most patients, pre-RT SA portended an increased risk of shoulder/arm morbidity. We argue that SA warrants further investigation. Incidentally, the observation of SA occurring after RT in one patient represents the second case of post-RT SA reported in the literature. PMID:22591589

  15. [Evaluating post-abortion care in 13 Colombian hospitals].

    PubMed

    Gómez-Sánchez, Pío I; Escandón, Inés; Gaitán-Duarte, Hernando

    2007-01-01

    This work describes Post-abortion Care strategy (PAC) experience in 13 Colombian hospitals regarding three components (counselling, suitable treatment and family planning). The study had quantitative (cross-sectional study) and qualitative components. Colombian hospitals receiving PAC training between 1999 and 2002 and fulfilling inclusion and exclusion criteria. Sequential convenience sampling was used; 127 patients, 13 managers and 39 health-care providers were interviewed. 26,199 women were treated for incomplete abortion during the study period. 40 % were treated using Manual Vacuum Aspiration (MVA) and 60 % using sharp curettage (SC). Family planning counselling was provided for 99,8 % of MVA cases; however, only 57,3 % of SC cases received it. There were 9 uterine perforations using SC and none in MVA cases (Chi square: 2.16; p=0.14). There were 2 vagal reactions using MVA. Uterine evacuation was needed in 13 SC cases but in only one MVA case (Chi square: 6,25 p=0.01). Patient satisfaction levels with hospital treatment were evaluated: 90 % of those receiving MVA treatment reported being satisfied or very satisfied, compared to just 60 % of those treated with SC. All health-care providers and 12 out of 13 managers reported satisfaction with the PAC strategy and with 12 out of 13 managers as well. MVA treatment was associated with less treatment-related morbidity and higher levels of satisfaction amongst patients. Most managers and all health-care providers stated their satisfaction with the PAC strategy.

  16. Evaluation of pre- and post-pyriform plasty nasal airflow.

    PubMed

    Sofia, Oscimar Benedito; Castro Neto, Ney P; Katsutani, Fernando S; Mitre, Edson I; Dolci, José E

    2017-05-06

    Nasal obstruction is a frequent complaint in otorhinolaryngology outpatient clinics, and nasal valve incompetence is the cause in most cases. Scientific publications describing surgical techniques on the upper and lower lateral cartilages to improve the nasal valve are also quite frequent. Relatively few authors currently describe surgical procedures in the piriform aperture for nasal valve augmentation. We describe the surgical technique called pyriform plasty and evaluate its effectiveness subjectively through the NOSE questionnaire and objectively through the rhinomanometry evaluation. To compare pre- and post-pyriform plasty nasal airflow variations using rhinomanometry and the NOSE questionnaire. Eight patients submitted to pyriform surgery were studied. These patients were screened in the otorhinolaryngology outpatient clinic among those who complained of nasal obstruction, and who had a positive response to Cottle maneuver. They answered the NOSE questionnaire and were submitted to preoperative rhinomanometry. After 90 days, they were reassessed through the NOSE questionnaire and the postoperative rhinomanometry. The results of these two parameters were compared pre- and postoperatively. Regarding the subjective measure, the NOSE questionnaire, seven patients reported improvement, of which two reported marked improvement, and one patient reported an unchanged obstructive condition. Regarding the rhinomanometry assessment, of 96 comparative measurements between the preoperative and postoperative periods, we obtained 68 measurements with an increase in nasal airflow in the postoperative period, 26 negative results, and two cases that remained unaltered between the preoperative and postoperative periods. When analyzing the results obtained in this study, we can conclude that the piriform plasty surgical procedure resulted in nasal airflow improvement in most of the obtained measurements. Copyright © 2017 Associação Brasileira de Otorrinolaringologia e

  17. Optimizing the post-graduate institutional program evaluation process.

    PubMed

    Lypson, Monica L; Prince, Mark E P; Kasten, Steven J; Osborne, Nicholas H; Cohan, Richard H; Kowalenko, Terry; Dougherty, Paul J; Reynolds, R Kevin; Spires, M Catherine; Kozlow, Jeffrey H; Gitlin, Scott D

    2016-02-17

    Reviewing program educational efforts is an important component of postgraduate medical education program accreditation. The post-graduate review process has evolved over time to include centralized oversight based on accreditation standards. The institutional review process and the impact on participating faculty are topics not well described in the literature. We conducted multiple Plan-Do-Study-Act (PDSA) cycles to identify and implement areas for change to improve productivity in our institutional program review committee. We also conducted one focus group and six in-person interviews with 18 committee members to explore their perspectives on the committee's evolution. One author (MLL) reviewed the transcripts and performed the initial thematic coding with a PhD level research associate and identified and categorized themes. These themes were confirmed by all participating committee members upon review of a detailed summary. Emergent themes were triangulated with the University of Michigan Medical School's Admissions Executive Committee (AEC). We present an overview of adopted new practices to the educational program evaluation process at the University of Michigan Health System that includes standardization of meetings, inclusion of resident members, development of area content experts, solicitation of committed committee members, transition from paper to electronic committee materials, and focus on continuous improvement. Faculty and resident committee members identified multiple improvement areas including the ability to provide high quality reviews of training programs, personal and professional development, and improved feedback from program trainees. A standing committee that utilizes the expertise of a group of committed faculty members and which includes formal resident membership has significant advantages over ad hoc or other organizational structures for program evaluation committees.

  18. Evaluating Nicotine Replacement Therapy and Stage-Based Therapies in a Population-Based Effectiveness Trial

    ERIC Educational Resources Information Center

    Velicer, Wayne F.; Friedman, Robert H.; Fava, Joseph L.; Gulliver, Suzy B.; Keller, Stefan; Sun, Xiaowu; Ramelson, Harley; Prochaska, James O.

    2006-01-01

    Pharmacological interventions for smoking cessation are typically evaluated using volunteer samples (efficacy trials) but should also be evaluated in population-based trials (effectiveness trials). Nicotine replacement therapy (NRT) alone and in combination with behavioral interventions was evaluated on a population of smokers from a New England…

  19. Evaluating Nicotine Replacement Therapy and Stage-Based Therapies in a Population-Based Effectiveness Trial

    ERIC Educational Resources Information Center

    Velicer, Wayne F.; Friedman, Robert H.; Fava, Joseph L.; Gulliver, Suzy B.; Keller, Stefan; Sun, Xiaowu; Ramelson, Harley; Prochaska, James O.

    2006-01-01

    Pharmacological interventions for smoking cessation are typically evaluated using volunteer samples (efficacy trials) but should also be evaluated in population-based trials (effectiveness trials). Nicotine replacement therapy (NRT) alone and in combination with behavioral interventions was evaluated on a population of smokers from a New England…

  20. 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.

    PubMed

    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.

  1. Exercise augmentation compared with usual care for post-traumatic stress disorder: a randomized controlled trial.

    PubMed

    Rosenbaum, S; Sherrington, C; Tiedemann, A

    2015-05-01

    To investigate the impact of a 12-week exercise programme in addition to usual care for post-traumatic stress disorder (PTSD). An assessor-blinded randomized controlled trial was conducted among 81 participants with a DSM-IV-TR diagnosis of primary PTSD. Participants were recruited after admission to an in-patient programme at a private hospital. Participants were randomized to receive either usual care (n=42), or exercise in addition to usual care (n=39). The exercise intervention involved three, 30-min resistance-training sessions/week and a pedometer-based walking programme. Usual care involved psychotherapy, pharmaceutical interventions, and group therapy. Primary outcome was PTSD symptoms assessed via the PTSD checklist-civilian version (PCL-C). Secondary outcomes included symptoms of depression, anthropometry, physical activity, mobility, strength, and sleep quality. Participants had a mean (SD) age of 47.8 years (12.1), 84% male. PTSD symptoms in the intervention group significantly reduced compared with the usual care group (mean difference=-5.4, 95% CI -10.5 to -0.3, P=0.04, n=58). There were significant between-group differences at follow-up for depressive symptoms, waist circumference, sleep quality, and sedentary time. This study provides the first evidence that an exercise intervention is associated with reduced PTSD and depressive symptoms, reduced waist circumference, and improved sleep quality. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Effects of varying post-warm-up recovery time on 200-m time-trial swim performance.

    PubMed

    Zochowski, Thomas; Johnson, Elizabeth; Sleivert, Gordon G

    2007-06-01

    Warm-up before athletic competition might enhance performance by affecting various physiological parameters. There are few quantitative data available on physiological responses to the warm-up, and the data that have been reported are inconclusive. Similarly, it has been suggested that varying the recovery period after a standardized warm-up might affect subsequent performance. To determine the effects of varying post-warm-up recovery time on a subsequent 200-m swimming time trial. Ten national-caliber swimmers (5 male, 5 female) each swam a 1500-m warm-up and performed a 200-m time trial of their specialty stroke after either 10 or 45 min of passive recovery. Subjects completed 1 time trial in each condition separated by 1 wk in a counterbalanced order. Blood lactate and heart rate were measured immediately after warm-up and 3 min before, immediately after, and 3 min after the time trial. Rating of perceived exertion was measured immediately after the warm-up and time trial. Time-trial performance was significantly improved after 10 min as opposed to 45 min recovery (136.80 +/- 20.38 s vs 138.69 +/- 20.32 s, P < .05). There were no significant differences between conditions for heart rate and blood lactate after the warm-up. Pre-time-trial heart rate, however, was higher in the 10-min than in the 45-min rest condition (109 +/- 14 beats/min vs 94 +/- 21 beats/min, P < .05). A post-warm-up recovery time of 10 min rather than 45 min is more beneficial to 200-m swimming time-trial performance.

  3. Analysis of Impact of Post-Treatment Biopsies in Phase I Clinical Trials

    PubMed Central

    Sweis, Randy F.; Drazer, Michael W.

    2016-01-01

    Purpose The use of biopsy-derived pharmacodynamic biomarkers is increasing in early-phase clinical trials. It remains unknown whether drug development is accelerated or enhanced by their use. We examined the impact of biopsy-derived pharmacodynamic biomarkers on subsequent drug development through a comprehensive analysis of phase I oncology studies from 2003 to 2010 and subsequent publications citing the original trials. Methods We conducted a search to identify and examine publications of phase I oncology studies including the use of biopsy-derived pharmacodynamic biomarkers between 2003 and 2010. Characteristics of those studies were extracted and analyzed, along with outcomes from the biomarker data. We then compiled and reviewed publications of subsequent phase II and III trials citing the original phase I biomarker studies to determine the impact on drug development. Results We identified 4,840 phase I oncology publications between 2003 and 2010. Seventy-two studies included a biopsy-derived pharmacodynamic biomarker. The proportion of biomarker studies including nondiagnostic biopsies increased over time (P = .002). A minimum of 1,873 tumor biopsies were documented in the 72 studies, 12 of which reported a statistically significant biomarker result. Thirty-three percent of studies (n = 24) were referenced by subsequent publications specifically with regard to the biomarkers. Only five positive biomarker studies were cited subsequently, and maximum tolerated dose was used for subsequent drug development in all cases. Conclusion Despite their increased use, the impact of biopsy-derived pharmacodynamic biomarkers in phase I oncology studies on subsequent drug development remains uncertain. No impact on subsequent dose or schedule was demonstrated. This issue requires further evaluation, given the risk and cost of such studies. PMID:26668350

  4. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials.

    PubMed

    Citrome, Leslie; Durgam, Suresh; Lu, Kaifeng; Ferguson, Paul; Laszlovszky, István

    2016-01-01

    Although most patients with schizophrenia are not aggressive, individuals with the disorder have increased risk of hostile behavior. Cariprazine, a dopamine D3 and D2 receptor partial agonist antipsychotic with preferential binding to D3 receptors, was evaluated for antihostility effects in patients with schizophrenia. Post hoc analyses were conducted using pooled data from 3 positive randomized, placebo-controlled, phase 2/3 studies in inpatients (18-60 years) with acute exacerbation of schizophrenia according to DSM-IV-TR criteria; data were collected between 2008 and 2011. The principal post hoc outcome was mean change from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) hostility item (P7); separate analyses adjusted for certain PANSS positive symptoms and sedation covariates. Analyses were based on the pooled intent-to-treat population (N = 1,466) using a mixed-effects model for repeated measures approach; separate analyses were conducted in subgroups categorized by baseline hostility item scores (P7: ≥ 2, ≥ 3, ≥ 4). The least squares mean difference (LSMD) in change from baseline to week 6 was statistically significant on all PANSS hostility item analyses in favor of cariprazine versus placebo: unadjusted (-0.28; P < .0001), adjusted for PANSS positive symptoms (-0.12; P < .05), adjusted for positive symptoms plus sedation (-0.12; P < .05). The magnitude of change for cariprazine increased with greater baseline hostility (LSMD vs placebo for ≥ 2, ≥ 3, ≥ 4 subgroups: -0.32, -0.37, -0.51, respectively; P < .01 all). Significant improvement on the hostility item was seen in cariprazine- versus placebo-treated patients with schizophrenia; the effect of cariprazine increased with greater levels of baseline hostility. ClinicalTrials.gov identifiers: NCT00694707, NCT01104766, and NCT01104779. © Copyright 2016 Physicians Postgraduate Press, Inc.

  5. A new trial design to accelerate tuberculosis drug development: the Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP).

    PubMed

    Phillips, Patrick P J; Dooley, Kelly E; Gillespie, Stephen H; Heinrich, Norbert; Stout, Jason E; Nahid, Payam; Diacon, Andreas H; Aarnoutse, Rob E; Kibiki, Gibson S; Boeree, Martin J; Hoelscher, Michael

    2016-03-23

    The standard 6-month four-drug regimen for the treatment of drug-sensitive tuberculosis has remained unchanged for decades and is inadequate to control the epidemic. Shorter, simpler regimens are urgently needed to defeat what is now the world's greatest infectious disease killer. We describe the Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP) as a novel hybrid phase II/III trial design to accelerate regimen development. In the Phase IIC STEP trial, the experimental regimen is given for the duration for which it will be studied in phase III (presently 3 or 4 months) and patients are followed for clinical outcomes of treatment failure and relapse for a total of 12 months from randomisation. Operating characteristics of the trial design are explored assuming a classical frequentist framework as well as a Bayesian framework with flat and sceptical priors. A simulation study is conducted using data from the RIFAQUIN phase III trial to illustrate how such a design could be used in practice. With 80 patients per arm, and two (2.5 %) unfavourable outcomes in the STEP trial, there is a probability of 0.99 that the proportion of unfavourable outcomes in a potential phase III trial would be less than 12 % and a probability of 0.91 that the proportion of unfavourable outcomes would be less than 8 %. With six (7.5 %) unfavourable outcomes, there is a probability of 0.82 that the proportion of unfavourable outcomes in a potential phase III trial would be less than 12 % and a probability of 0.41 that it would be less than 8 %. Simulations using data from the RIFAQUIN trial show that a STEP trial with 80 patients per arm would have correctly shown that the Inferior Regimen should not proceed to phase III and would have had a high chance (0.88) of either showing that the Successful Regimen could proceed to phase III or that it might require further optimisation. Collection of definitive clinical outcome data in a relatively small number of participants over

  6. Evaluation of cognitive restructuring for post-traumatic stress disorder in people with severe mental illness

    PubMed Central

    Mueser, Kim T.; Gottlieb, Jennifer D.; Xie, Haiyi; Lu, Weili; Yanos, Philip T.; Rosenberg, Stanley D.; Silverstein, Steven M.; Duva, Stephanie Marcello; Minsky, Shula; Wolfe, Rosemarie S.; McHugo, Gregory J.

    2015-01-01

    Background A cognitive–behavioural therapy (CBT) programme designed for post-traumatic stress disorder (PTSD) in people with severe mental illness, including breathing retraining, education and cognitive restructuring, was shown to be more effective than usual services. Aims To evaluate the incremental benefit of adding cognitive restructuring to the breathing retraining and education components of the CBT programme (trial registration: clinicaltrials.gov identifier: NCT00494650). Method In all, 201 people with severe mental illness and PTSD were randomised to 12- to 16-session CBT or a 3-session brief treatment programme (breathing retraining and education). The primary outcome was PTSD symptom severity. Secondary outcomes were PTSD diagnosis, other symptoms, functioning and quality of life. Results There was greater improvement in PTSD symptoms and functioning in the CBT group than in the brief treatment group, with both groups improving on other outcomes and effects maintained 1-year post-treatment. Conclusions Cognitive restructuring has a significant impact beyond breathing retraining and education in the CBT programme, reducing PTSD symptoms and improving functioning in people with severe mental illness. PMID:25858178

  7. Evaluation of cognitive restructuring for post-traumatic stress disorder in people with severe mental illness.

    PubMed

    Mueser, Kim T; Gottlieb, Jennifer D; Xie, Haiyi; Lu, Weili; Yanos, Philip T; Rosenberg, Stanley D; Silverstein, Steven M; Duva, Stephanie Marcello; Minsky, Shula; Wolfe, Rosemarie S; McHugo, Gregory J

    2015-06-01

    A cognitive-behavioural therapy (CBT) programme designed for post-traumatic stress disorder (PTSD) in people with severe mental illness, including breathing retraining, education and cognitive restructuring, was shown to be more effective than usual services. To evaluate the incremental benefit of adding cognitive restructuring to the breathing retraining and education components of the CBT programme (trial registration: clinicaltrials.gov identifier: NCT00494650). In all, 201 people with severe mental illness and PTSD were randomised to 12- to 16-session CBT or a 3-session brief treatment programme (breathing retraining and education). The primary outcome was PTSD symptom severity. Secondary outcomes were PTSD diagnosis, other symptoms, functioning and quality of life. There was greater improvement in PTSD symptoms and functioning in the CBT group than in the brief treatment group, with both groups improving on other outcomes and effects maintained 1-year post-treatment. Cognitive restructuring has a significant impact beyond breathing retraining and education in the CBT programme, reducing PTSD symptoms and improving functioning in people with severe mental illness. © The Royal College of Psychiatrists 2015.

  8. Exercise on prescription: trial protocol and evaluation of outcomes.

    PubMed

    Sørensen, Jes B; Kragstrup, Jakob; Kjaer, Kirsten; Puggaard, Lis

    2007-03-02

    In many countries exercise prescriptions are used in an attempt to initiate a physically active lifestyle in sedentary populations. Previous studies have primarily evaluated low intensive exercise prescription interventions and found moderately positive effects on physical activity and aerobic fitness. In a highly intensive Danish exercise prescription scheme called 'Exercise on Prescription' (EoP) the general practitioners can prescribe EoP to sedentary patients with lifestyle diseases. The aim of this randomized trial is to assess the short- and long-term effects of the EoP scheme. Thus, the aim of this paper is to describe the randomized controlled trial designed for evaluating effectiveness of EoP, and to present results from validations of outcome measures. EoP involves a 16-week supervised training intervention and five counselling sessions (health profiles). All patients referred to EoP were eligible for the trial and were offered participation during the baseline health profile. Comparisons between the EoP group and the control group were made at baseline, and after four and ten months. Physiological measures used were maximal oxygen uptake (VO2max), glycosylated haemoglobin (HbA1c), bodyweight, and BMI. Patient-reported measures used were physical activity, health-related quality of life, amount and intensity of exercise, compliance with national guidelines for physical activity, and physical fitness. The validation of the cycle ergometer test found a strong correlation between maximal work capacity and VO2max, and acceptable test-retest reliability at group level. Calibration of the HbA1c apparatus was stable over ten weeks with minimal use, and test-retest reliability was good. High agreement percents were found for test-retest reliability for the self-administered questionnaire. The trial is designed to provide information about the effectiveness of the EoP scheme. The trial is part of a health technology assessment of EoP, which besides the

  9. Exercise on Prescription: trial protocol and evaluation of outcomes

    PubMed Central

    Sørensen, Jes B; Kragstrup, Jakob; Kjær, Kirsten; Puggaard, Lis

    2007-01-01

    Background In many countries exercise prescriptions are used in an attempt to initiate a physically active lifestyle in sedentary populations. Previous studies have primarily evaluated low intensive exercise prescription interventions and found moderately positive effects on physical activity and aerobic fitness. In a highly intensive Danish exercise prescription scheme called 'Exercise on Prescription' (EoP) the general practitioners can prescribe EoP to sedentary patients with lifestyle diseases. The aim of this randomized trial is to assess the short- and long-term effects of the EoP scheme. Thus, the aim of this paper is to describe the randomized controlled trial designed for evaluating effectiveness of EoP, and to present results from validations of outcome measures. Methods/Design EoP involves a 16-week supervised training intervention and five counselling sessions (health profiles). All patients referred to EoP were eligible for the trial and were offered participation during the baseline health profile. Comparisons between the EoP group and the control group were made at baseline, and after four and ten months. Physiological measures used were maximal oxygen uptake (VO2max), glycosylated haemoglobin (HbA1c), bodyweight, and BMI. Patient-reported measures used were physical activity, health-related quality of life, amount and intensity of exercise, compliance with national guidelines for physical activity, and physical fitness. The validation of the cycle ergometer test found a strong correlation between maximal work capacity and VO2max, and acceptable test-retest reliability at group level. Calibration of the HbA1c apparatus was stable over ten weeks with minimal use, and test-retest reliability was good. High agreement percents were found for test-retest reliability for the self-administered questionnaire. Discussion The trial is designed to provide information about the effectiveness of the EoP scheme. The trial is part of a health technology assessment

  10. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial.

    PubMed

    Kaji, Ryuji; Osako, Yuka; Suyama, Kazuaki; Maeda, Toshio; Uechi, Yasuyuki; Iwasaki, Masaru

    2010-08-01

    Lower limb spasticity in post-stroke patients can impair ambulation and reduces activities of daily living (ADL) performance of patients. Botulinum toxin type A (BoNTA) has been shown effective for upper limb spasticity. This study assesses the treatment of lower limb spasticity in a large placebo-controlled clinical trial. In this multicenter, randomized, double-blind, parallel-group, placebo-controlled study, we evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke lower limb spasticity. One hundred twenty patients with lower limb spasticity were randomized to a single treatment with BoNTA 300 U or placebo. The tone of the ankle flexor was assessed at baseline and through 12 weeks using the Modified Ashworth Scale (MAS). Gait pattern and speed of gait were also assessed. The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS ankle score. Significant improvement in spasticity with BoNTA 300 U was demonstrated by a mean difference in the AUC of the change from baseline in the MAS ankle score between the BoNTA and placebo groups (-3.428; 95% CIs, -5.841 to -1.016; p = 0.006; t test). A significantly greater decrease from baseline in the MAS ankle score was noted at weeks 4, 6 and 8 in the BoNTA group compared to the placebo group (p < 0.001). Significant improvement in the Clinicians Global Impression was noted by the investigator at weeks 4, 6 and 8 (p = 0.016-0.048, Wilcoxon test), but not by the patient or physical/occupational therapist. Assessments of gait pattern using the Physician's Rating Scale and speed of gait revealed no significant treatment differences but showed a tendency towards improvement with BoNTA. No marked difference was noted in the frequency of treatment-related adverse events between BoNTA and placebo groups. This was the first large-scale trial to indicate that BoNTA significantly reduced spasticity in lower limb muscles.

  11. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial

    PubMed Central

    Osako, Yuka; Suyama, Kazuaki; Maeda, Toshio; Uechi, Yasuyuki; Iwasaki, Masaru

    2010-01-01

    Lower limb spasticity in post-stroke patients can impair ambulation and reduces activities of daily living (ADL) performance of patients. Botulinum toxin type A (BoNTA) has been shown effective for upper limb spasticity. This study assesses the treatment of lower limb spasticity in a large placebo-controlled clinical trial. In this multicenter, randomized, double-blind, parallel-group, placebo-controlled study, we evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke lower limb spasticity. One hundred twenty patients with lower limb spasticity were randomized to a single treatment with BoNTA 300 U or placebo. The tone of the ankle flexor was assessed at baseline and through 12 weeks using the Modified Ashworth Scale (MAS). Gait pattern and speed of gait were also assessed. The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS ankle score. Significant improvement in spasticity with BoNTA 300 U was demonstrated by a mean difference in the AUC of the change from baseline in the MAS ankle score between the BoNTA and placebo groups (−3.428; 95% CIs, −5.841 to −1.016; p = 0.006; t test). A significantly greater decrease from baseline in the MAS ankle score was noted at weeks 4, 6 and 8 in the BoNTA group compared to the placebo group (p < 0.001). Significant improvement in the Clinicians Global Impression was noted by the investigator at weeks 4, 6 and 8 (p = 0.016–0.048, Wilcoxon test), but not by the patient or physical/occupational therapist. Assessments of gait pattern using the Physician’s Rating Scale and speed of gait revealed no significant treatment differences but showed a tendency towards improvement with BoNTA. No marked difference was noted in the frequency of treatment-related adverse events between BoNTA and placebo groups. This was the first large-scale trial to indicate that BoNTA significantly reduced spasticity in lower limb

  12. Effects of esomeprazole on the healing process of post-endoscopic submucosal dissection gastric ulcers: a single arm, prospective trial

    PubMed Central

    Ichida, Takashi; Kusano, Fumihiko; Sakai, Yoshinori

    2016-01-01

    Objectives: Gastric endoscopic submucosal dissection (ESD) is currently a standard procedure. ESD enables en-bloc resection of large lesions, while inducing larger artificial ulcers to a greater extent than conventional procedures. Several studies have reported that proton pump inhibitors (PPIs) prevent delayed bleeding and expedite the artificial ulcer healing process. Esomeprazole, an S-isomer of omeprazole, is reportedly one of strongest inhibitors of gastric acid secretion. Previous studies have examined the effectiveness of esomeprazole. Our goal was to verify the effects of esomeprazole on artificial ulcers in a prospective study. Methods: A total of 185 patients underwent ESD for gastric neoplasms at our hospital between January 2013 and June 2015. Among these 185 patients, 49 post-ESD scar lesions were included in this prospective trial. First, 20 mg esomeprazole was orally administered to all subjects before and after the procedure. We then evaluated the delayed bleeding rate and ulcer scarring rates at 4 weeks and 8 weeks after the procedure by using a gastric ulcer stage system. Results: There was one case of delayed bleeding (2.0%). Regardless of Helicobacter pylori infection status, ulcer scarring rates at weeks 4 and 8 were respectively 28.6% (14/49) and 98% (48/49). Conclusions: Our results suggest that oral administration of esomeprazole alone may be sufficient for prompt healing of artificial gastric ulcers induced by ESD (UMIN000009367). PMID:27928455

  13. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial.

    PubMed

    Jones, Christina; Bäckman, Carl; Capuzzo, Maurizia; Egerod, Ingrid; Flaatten, Hans; Granja, Cristina; Rylander, Christian; Griffiths, Richard D

    2010-01-01

    Patients recovering from critical illness have been shown to be at risk of developing Post Traumatic Stress disorder (PTSD). This study was to evaluate whether a prospectively collected diary of a patient's intensive care unit (ICU) stay when used during convalescence following critical illness will reduce the development of new onset PTSD. Intensive care patients with an ICU stay of more than 72 hours were recruited to a randomised controlled trial examining the effect of a diary outlining the details of the patients ICU stay on the development of acute PTSD. The intervention patients received their ICU diary at 1 month following critical care discharge and the final assessment of the development of acute PTSD was made at 3 months. 352 patients were randomised to the study at 1 month. The incidence of new cases of PTSD was reduced in the intervention group compared to the control patients (5% versus 13%, P = 0.02). The provision of an ICU diary is effective in aiding psychological recovery and reducing the incidence of new PTSD. NCT00912613.

  14. Randomized controlled trial of accelerated resolution therapy (ART) for symptoms of combat-related post-traumatic stress disorder (PTSD).

    PubMed

    Kip, Kevin E; Rosenzweig, Laney; Hernandez, Diego F; Shuman, Amy; Sullivan, Kelly L; Long, Christopher J; Taylor, James; McGhee, Stephen; Girling, Sue Ann; Wittenberg, Trudy; Sahebzamani, Frances M; Lengacher, Cecile A; Kadel, Rajendra; Diamond, David M

    2013-12-01

    Therapies for post-traumatic stress disorder (PTSD) endorsed by the Department of Defense and Veterans Administration are relatively lengthy, costly, and yield variable success. We evaluated Accelerated Resolution Therapy (ART) for the treatment of combat-related psychological trauma. A randomized controlled trial of ART versus an Attention Control (AC) regimen was conducted among 57 U.S. service members/veterans. After random assignment, those assigned to AC were offered crossover to ART, with 3-month follow-up on all participants. Self-report symptoms of PTSD and comorbidities were analyzed among study completers and by the intention-to-treat principle. Mean age was 41 ± 13 years with 19% female, 54% Army, and 68% with prior PTSD treatment. The ART was delivered in 3.7 ± 1.1 sessions with a 94% completion rate. Mean reductions in symptoms of PTSD, depression, anxiety, and trauma-related guilt were significantly greater (p < 0.001) with ART compared to AC. Favorable results for those treated with ART persisted at 3 months, including reduction in aggression (p < 0.0001). Adverse treatment-related events were rare and not serious. ART appears to be a safe and effective treatment for symptoms of combat-related PTSD, including refractory PTSD, and is delivered in significantly less time than therapies endorsed by the Department of Defense and Veterans Administration. Reprint & Copyright © 2013 Association of Military Surgeons of the U.S.

  15. Protocol for a pilot randomised controlled trial of an online intervention for post-treatment cancer survivors with persistent fatigue

    PubMed Central

    Corbett, Teresa; Walsh, Jane C; Groarke, AnnMarie; Moss-Morris, Rona; McGuire, Brian E

    2016-01-01

    Introduction Many post-treatment cancer survivors experience persistent fatigue that can disrupt attempts to resume normal everyday activities after treatment. Theoretical models that aim to explain contributory factors that initiate and sustain fatigue symptoms, or that influence the efficacy of interventions for cancer-related fatigue (CrF) require testing. Adjustment to fatigue is likely to be influenced by coping behaviours that are guided by the representations of the symptom. Objectives This paper describes the protocol for a pilot trial of a systematically and theoretically designed online intervention to enable self-management of CrF after cancer treatment. Methods and analysis This 2-armed randomised controlled pilot trial will study the feasibility and potential effectiveness of an online intervention. Participants will be allocated to either the online intervention (REFRESH (Recovery from Cancer-Related Fatigue)), or a leaflet comparator. Participants 80 post-treatment cancer survivors will be recruited for the study. Interventions An 8-week online intervention based on cognitive–behavioural therapy. Primary and secondary outcome measures The primary outcome is a change in fatigue as measured by the Piper Fatigue Scale (revised). Quality of life will be measured using the Quality of Life in Adult Survivors of Cancer Scale. Outcome measures will be collected at baseline, and at completion of intervention. Results The feasibility of trial procedures will be tested, as well as the effect of the intervention on the outcomes. Conclusions This study may lead to the development of a supportive resource to target representations and coping strategies of cancer survivors with CrF post-treatment. Setting Recruitment from general public in Ireland. Ethics and dissemination This trial was approved by the Research Ethics Committee at National University of Ireland Galway in January 2013. Trial results will be communicated in a peer-reviewed journal. Trial

  16. Evaluation of push-out bond strength of two endodontic post systems.

    PubMed

    Mastoras, Konstantinos; Vasiliadis, Leonidas; Koulaouzidou, Elizabeth; Gogos, Christos

    2012-04-01

    The aim of this study was to evaluate the push-out bond strengths of a new polyfiber post system and a fiber post that were adhesively luted with a dual-cure resin cement. Forty single-rooted human maxillary teeth were sectioned below the cementoenamel junction, and the roots were endodontically treated. The roots were randomly divided into 2 groups of 20 specimens each according to the post type used: SpiraPost (group A; DMG, Englewood, NJ) and DT Light-Post Illusion X-RO (group B; Bisco Inc, Schaumburg, IL). All posts were cemented with dual-cure resin cement. Bonded specimens were cut into 1-mm-thick sections, and push-out tests were performed using a universal testing machine. All specimens were loaded until fracture, and the failure modes were evaluated with a stereomicroscope at 50× magnification. Representative specimens were analyzed by scanning electron microscopy. Push-out bond strength was significantly affected by the type of post (P < .05). In all root sections, the SpiraPost push-out bond strength values were significantly higher than that those of DT Light-Post Illusion X-RO (P < .05). Cohesive failure within the post was the most frequent type of failure for the SpiraPost system. In all root segments, the SpiraPost system provided significantly increased post retention compared with the fiber post. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  17. Evaluation of Cable Harness Post-Installation Testing. Part B

    NASA Technical Reports Server (NTRS)

    King, M. S.; Iannello, C. J.

    2011-01-01

    The Cable Harness Post-Installation Testing Report was written in response to an action issued by the Ares Project Control Board (PCB). The action for the Ares I Avionics & Software Chief Engineer and the Avionics Integration and Vehicle Systems Test Work Breakdown Structure (WBS) Manager in the Vehicle Integration Office was to develop a set of guidelines for electrical cable harnesses. Research showed that post-installation tests have been done since the Apollo era. For Ares I-X, the requirement for post-installation testing was removed to make it consistent with the avionics processes used on the Atlas V expendable launch vehicle. Further research for the report involved surveying government and private sector launch vehicle developers, military and commercial aircraft, spacecraft developers, and harness vendors. Responses indicated crewed launch vehicles and military aircraft perform post-installation tests. Key findings in the report were as follows: Test requirements identify damage, human-rated vehicles should be tested despite the identification of statistically few failures, data does not support the claim that post-installation testing damages the harness insulation system, and proper planning can reduce overhead associated with testing. The primary recommendation of the report is for the Ares projects to retain the practice of post-fabrication and post-installation cable harness testing.

  18. Effects of non-invasive brain stimulation on post-stroke dysphagia: A systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    Pisegna, Jessica M.; Kaneoka, Asako; Pearson, William G.; Kumar, Sandeep; Langmore, Susan E.

    2017-01-01

    Objective The primary aim of this review is to evaluate the effects of non-invasive brain stimulation on post-stroke dysphagia. Methods Thirteen databases were systematically searched through July 2014. Studies had to meet pre-specified inclusion and exclusion criteria. Each study's methodological quality was examined. Effect sizes were calculated from extracted data and combined for an overall summary statistic. Results Eight randomized controlled trials were included. These trials revealed a significant, moderate pooled effect size (0.55; 95% CI = 0.17, 0.93; p = 0.004). Studies stimulating the affected hemisphere had a combined effect size of 0.46 (95% CI = −0.18, 1.11; p = 0.16); studies stimulating the unaffected hemisphere had a combined effect size of 0.65 (95% CI = 0.14, 1.16; p = 0.01). At long-term follow up, three studies demonstrated a large but non-significant pooled effect size (0.81, p = 0.11). Conclusions This review found evidence for the efficacy of non-invasive brain stimulation on post-stroke dysphagia. A significant effect size resulted when stimulating the unaffected rather than the affected hemisphere. This finding is in agreement with previous studies implicating the plasticity of cortical neurons in the unaffected hemisphere. Significance Non-invasive brain stimulation appears to assist cortical reorganization in post-stroke dysphagia but emerging factors highlight the need for more data. PMID:26070517

  19. [Technical specifications for post-marketing pharmacoeconomic evaluation of Chinese medicine (draft version for comments)].

    PubMed

    Xie, Yan-Ming; Wang, Xin; Wang, Nuo; Chang, Yan-Peng

    2013-09-01

    Pharmacoeconomics is an important part of the post-marketing evaluation of Chinese medicine, post-marketing pharmacoeconomic evaluation can better reflect the clinical and market value of Chinese medicine, the purpose of establishing the technical specifications for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines more scientific and fair. Every country's technical specifications for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the technical specifications which take into account the special characteristics of Chinese medicine; these are in preparation for post-marketing pharmacoeconomic evaluation Chinese medicine.

  20. Functional goal achievement in post-stroke spasticity patients: the BOTOX® Economic Spasticity Trial (BEST).

    PubMed

    Ward, Anthony B; Wissel, Jörg; Borg, Jörgen; Ertzgaard, Per; Herrmann, Christoph; Kulkarni, Jai; Lindgren, Kristina; Reuter, Iris; Sakel, Mohamed; Säterö, Patrik; Sharma, Satyendra; Wein, Theodore; Wright, Nicola; Fulford-Smith, Antony

    2014-06-01

    Evaluate changes in active and passive function with onabotulinumtoxinA + standard of care within goal-oriented rehabilitation programmes in adults with focal post-stroke spasticity. Prospective, 24-week double-blind study with an open-label extension. Subjects were randomized to onabotulinumtoxinA + standard of care or placebo + standard of care, at baseline and at 12 weeks, if judged appropriate, with follow-up to 52 weeks. The primary endpoint was the number of patients achieving their principal active functional goal at 24 weeks (or 10 weeks after an optional second injection). Secondary endpoints included achievement of a different active or a passive goal at this timepoint. The intent-to-treat population comprised 273 patients. The proportion of patients achieving their principal active functional goal and secondary active functional goal with onabotulinumtoxinA + standard of care was not statistically different from placebo + standard of care. Significantly more patients achieved their secondary passive goal with onabotulinumtoxinA + standard of care (60.0%) vs. placebo + standard of care (38.6%) (odds ratio, 2.46; 95% confidence interval, 1.18-5.14) as well as higher Goal Attainment Scaling levels for upper limb and ankle flexor subgroups. Addition of onabotulinumtoxinA to standard of care as part of goal-oriented rehabilitation in post-stroke spasticity patients significantly increased passive goal achievement and was associated with higher levels of active function.

  1. Clinical evaluation of carbon fiber reinforced carbon endodontic post, glass fiber reinforced post with cast post and core: A one year comparative clinical study

    PubMed Central

    Preethi, GA; Kala, M

    2008-01-01

    Aim: Restoring endodontically treated teeth is one of the major treatments provided by the dental practitioner. Selection and proper use of restorative materials continues to be a source of frustration for many clinicians. There is controversy surrounding the most suitable choice of restorative material and the placement method that will result in the highest probability of successful treatment. This clinical study compares two different varieties of fiber posts and one cast post and core in terms of mobility of crown margin under finger pressure, recurrent caries detected at the crown margin, fracture of the restoration, fracture of the root and periapical and periodontal pathology requiring crown removal over the period of 12months as evaluated by clinical and radiographical examination. Materials and Methods: 30 root canal treated, single rooted maxillary anterior teeth of 25 patients in the age range of 18–60 years where a post retained crown was indicated were selected for the study between January 2007 and August 2007; and prepared in a standard clinical manner. It was divided into 3 groups of 10 teeth in each group. After post space preparation, the Carbon fiber and Glass fiber reinforced posts were cemented with Scotch bond multipurpose plus bonding agent and RelyX adhesive resin cement in the first and second groups respectively. The Cast post and cores were cemented with Zinc Phosphate cement in the third group. Following post- cementation, the preparation was further refined and a rubber base impression was taken for metal-ceramic crowns which was cemented with Zinc Phosphate cement. A baseline periapical radiograph was taken once each crown was cemented. All patients were evaluated after one week (baseline), 3 months, 6 months and one year for following characteristics mobility of crown margin under finger pressure, recurrent caries detected at the crown margin, fracture of the restoration, fracture of the root and periapical and periodontal pathology

  2. A pragmatic cluster randomised trial evaluating three implementation interventions

    PubMed Central

    2012-01-01

    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 national randomised

  3. Dentin-like versus Rigid Endodontic Post: Eleven-year Randomized Controlled Pilot Trial on No-wall to Two-wall Defects.

    PubMed

    Naumann, Michael; Sterzenbach, Guido; Dietrich, Thomas; Bitter, Kerstin; Frankenberger, Roland; von Stein-Lausnitz, Manja

    2017-09-23

    This is the first long-term randomized controlled trial to evaluate dentin-like glass fiber posts (GFPs) compared with rather rigid titanium posts (TPs) for post-endodontic restoration of severely damaged endodontically treated teeth with 2 or fewer remaining cavity walls. Ninety-one subjects in need of post-endodontic restorations were randomly assigned to receive either a tapered GFP (n = 45) or TP (n = 46). Posts were adhesively luted by using self-adhesive resin cement, followed by composite core build-up and preparation of 2-mm ferrule design. Primary end point was loss of restoration for any reason. Kaplan-Meier curves were constructed, and log-rank test was calculated (P < .05). After a follow-up of 132 months, 17 GFP and 20 TP restorations survived, and 19 failed (12 GFP, 7 TP). Failure modes for GFP were root fracture (n = 4), core fracture (n = 1), secondary caries (n = 1), endodontic failure (n = 2), extraction because of tooth mobility grade III associated with insufficient design of removable partial denture (n = 1), tooth fracture (n = 1), and changes in treatment plan (n = 2); failure modes for TP were endodontic failure (n = 5), root fracture (n = 1), and 1 extraction for other reasons. Cumulative survival probability was 58.7% for GFP and 74.2% for TP. When using self-adhesively luted prefabricated posts, resin composite core build-up, and 2-mm ferrule to reconstruct severely damaged endodontically treated teeth, tooth survival is not influenced by post rigidity. Survival decreased rapidly after 8 years of observation in both groups. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  4. The role of movement errors in modifying spatiotemporal gait asymmetry post stroke: a randomized controlled trial.

    PubMed

    Lewek, Michael D; Braun, Carty H; Wutzke, Clint; Giuliani, Carol

    2017-07-01

    Current rehabilitation to improve gait symmetry following stroke is based on one of two competing motor learning strategies: minimizing or augmenting symmetry errors. We sought to determine which of those motor learning strategies best improves overground spatiotemporal gait symmetry. Randomized controlled trial. Rehabilitation research lab. In all, 47 participants (59 ± 12 years old) with chronic hemiparesis post stroke and spatiotemporal gait asymmetry were randomized to error augmentation, error minimization, or conventional treadmill training (control) groups. To augment or minimize asymmetry on a step-by-step basis, we developed a responsive, "closed-loop" control system, using a split-belt instrumented treadmill that continuously adjusted the difference in belt speeds to be proportional to the patient's current asymmetry. Overground spatiotemporal asymmetries and gait speeds were collected prior to and following 18 training sessions. Step length asymmetry reduced after training, but stance time did not. There was no group × time interaction. Gait speed improved after training, but was not affected by type of asymmetry, or group. Of those who trained to modify step length asymmetry, there was a moderately strong linear relationship between the change in step length asymmetry and the change in gait speed. Augmenting errors was not superior to minimizing errors or providing only verbal feedback during conventional treadmill walking. Therefore, the use of verbal feedback to target spatiotemporal asymmetry, which was common to all participants, appears to be sufficient to reduce step length asymmetry. Alterations in stance time asymmetry were not elicited in any group.

  5. Evaluating an extended rehabilitation service for stroke patients (EXTRAS): study protocol for a randomised controlled trial.

    PubMed

    Rodgers, Helen; Shaw, Lisa; Cant, Robin; Drummond, Avril; Ford, Gary A; Forster, Anne; Hills, Katie; Howel, Denise; Laverty, Anne-Marie; McKevitt, Christopher; McMeekin, Peter; Price, Christopher

    2015-05-05

    Development of longer term stroke rehabilitation services is limited by lack of evidence of effectiveness for specific interventions and service models. We describe the protocol for a multicentre randomised controlled trial which is evaluating an extended stroke rehabilitation service. The extended service commences when routine 'organised stroke care' (stroke unit and early supported discharge (ESD)) ends. This study is a multicentre randomised controlled trial with health economic and process evaluations. It is set within NHS stroke services which provide ESD. Participants are adults who have experienced a new stroke (and carer if appropriate), discharged from hospital under the care of an ESD team. The intervention group receives an extended stroke rehabilitation service provided for 18 months following completion of ESD. The extended rehabilitation service involves regular contact with a senior ESD team member who leads and coordinates further rehabilitation. Contact is usually by telephone. The control group receives usual stroke care post-ESD. Usual care may involve referral of patients to a range of rehabilitation services upon completion of ESD in accordance with local clinical practice. Randomisation is via a central independent web-based service. The primary outcome is extended activities of daily living (Nottingham Extended Activities of Daily Living Scale) at 24 months post-randomisation. Secondary outcomes (at 12 and 24 months post-randomisation) are health status, quality of life, mood and experience of services for patients, and quality of life, experience of services and carer stress for carers. Resource use and adverse events are also collected. Outcomes are undertaken by a blinded assessor. Implementation and delivery of the extended stroke rehabilitation service will also be described. Semi-structured interviews will be conducted with a subsample of participants and staff to gain insight into perceptions and experiences of rehabilitation services

  6. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be...

  7. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be...

  8. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be...

  9. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be...

  10. Trial 1 Versus Trial 2 of the Test of Memory Malingering: Evaluating Accuracy Without a "Gold Standard".

    PubMed

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

    2017-03-02

    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

  11. Effect on peer review of telling reviewers that their signed reviews might be posted on the web: randomised controlled trial.

    PubMed

    van Rooyen, Susan; Delamothe, Tony; Evans, Stephen J W

    2010-11-16

    To see whether telling peer reviewers that their signed reviews of original research papers might be posted on the BMJ's website would affect the quality of their reviews. Randomised controlled trial. A large international general medical journal based in the United Kingdom. 541 authors, 471 peer reviewers, and 12 editors. Consecutive eligible papers were randomised either to have the reviewer's signed report made available on the BMJ's website alongside the published paper (intervention group) or to have the report made available only to the author-the BMJ's normal procedure (control group). The intervention was the act of revealing to reviewers-after they had agreed to review but before they undertook their review-that their signed report might appear on the website. The main outcome measure was the quality of the reviews, as independently rated on a scale of 1 to 5 using a validated instrument by two editors and the corresponding author. Authors and editors were blind to the intervention group. Authors rated review quality before the fate of their paper had been decided. Additional outcomes were the time taken to complete the review and the reviewer's recommendation regarding publication. 558 manuscripts were randomised, and 471 manuscripts remained after exclusions. Of the 1039 reviewers approached to take part in the study, 568 (55%) declined. Two editors' evaluations of the quality of the peer review were obtained for all 471 manuscripts, with the corresponding author's evaluation obtained for 453. There was no significant difference in review quality between the intervention and control groups (mean difference for editors 0.04, 95% CI -0.09 to 0.17; for authors 0.06, 95% CI -0.09 to 0.20). Any possible difference in favour of the control group was well below the level regarded as editorially significant. Reviewers in the intervention group took significantly longer to review (mean difference 25 minutes, 95% CI 3.0 to 47.0 minutes). Telling peer reviewers

  12. Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes: a post hoc analysis of two 3-week clinical trials

    PubMed Central

    2011-01-01

    Background Asenapine demonstrated superiority over placebo for mania in bipolar I disorder patients experiencing acute current manic or mixed episodes in 2 randomized, placebo-and olanzapine-controlled trials. We report the results of exploratory pooled post hoc analyses from these trials evaluating asenapine's effects on depressive symptoms in patients from these trials with significant baseline depressive symptoms. Methods In the original trials (A7501004 [NCT00159744], A7501005 [NCT00159796]), 977 patients were randomized to flexible-dose sublingual asenapine (10 mg twice daily on day 1; 5 or 10 mg twice daily thereafter), placebo, or oral olanzapine 5-20 mg once daily for 3 weeks. Three populations were defined using baseline depressive symptoms: (1) Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥20 (n = 132); (2) Clinical Global Impression for Bipolar Disorder-Depression (CGI-BP-D) scale severity score ≥4 (n = 170); (3) diagnosis of mixed episodes (n = 302) by investigative site screening. For each population, asenapine and olanzapine were independently compared with placebo using least squares mean change from baseline on depressive symptom measures. Results Decreases in MADRS total score were statistically greater with asenapine versus placebo at days 7 and 21 in all populations; differences between olanzapine and placebo were not significant. Decreases in CGI-BP-D score were significantly greater with asenapine versus placebo at day 7 in all categories and day 21 in population 1; CGI-BP-D score reductions were significantly greater with olanzapine versus placebo at day 21 in population 1 and day 7 in populations 2 and 3. Conclusions These post hoc analyses show that asenapine reduced depressive symptoms in bipolar I disorder patients experiencing acute manic or mixed episodes with clinically relevant depressive symptoms at baseline; olanzapine results appeared to be less consistent. Controlled studies of asenapine in patients with acute

  13. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain.

    PubMed

    Elzaki, Wail M; Abubakr, Neamat H; Ziada, Hassan M; Ibrahim, Yahia E

    2016-06-01

    The present clinical trial aimed to evaluate the efficiency of paracetamol alone and in combination with 3 different nonsteroidal anti-inflammatory drugs for control of post-endodontic pain. The inclusion criteria were moderate to severe pain of irreversible pulpitis, by using the Verbal Rating Scale and a 4-10 score on the Numerical Rating Scale, on anterior or premolar teeth, as well as the absence of signs and symptoms of apical periodontitis. One hundred eighty-five trial medications with placebo were prepared, and 170 participants completed the trial. There were 5 groups. P-group received 4 gelatinous capsules of a single dose of paracetamol alone. The IP-group received similar capsules of a single dose of combined ibuprofen/paracetamol. MP-group received combined mefenamic acid/paracetamol, and DP-group received combined diclofenac K/paracetamol. A Plb-group received doubled gelatinous capsules with no medications as a single dose, which had the same weight and appearance as the medicated capsules, to be the placebo. Pain intensity was measured after initial endodontic therapy and instrumentation by using the Verbal Rating Scale and Numerical Rating Scale. IP-group (ibuprofen/paracetamol) had the most pain reduction, followed by DP-group (combined diclofenac K/paracetamol), then MP-group, followed by P-group, whereas Plb-group had the least pain reduction (P < .05). The combination of ibuprofen/paracetamol, taken immediately after initial endodontic therapy and root canal preparation in teeth with irreversible pulpitis, reduced post-endodontic pain (ClinicalTrials.gov no.: NCT02417337). Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  14. Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes: a post hoc analysis of two 3-week clinical trials.

    PubMed

    Szegedi, Armin; Zhao, Jun; van Willigenburg, Arjen; Nations, Kari R; Mackle, Mary; Panagides, John

    2011-06-20

    Asenapine demonstrated superiority over placebo for mania in bipolar I disorder patients experiencing acute current manic or mixed episodes in 2 randomized, placebo-and olanzapine-controlled trials. We report the results of exploratory pooled post hoc analyses from these trials evaluating asenapine's effects on depressive symptoms in patients from these trials with significant baseline depressive symptoms. In the original trials (A7501004 [NCT00159744], A7501005 [NCT00159796]), 977 patients were randomized to flexible-dose sublingual asenapine (10 mg twice daily on day 1; 5 or 10 mg twice daily thereafter), placebo, or oral olanzapine 5-20 mg once daily for 3 weeks. Three populations were defined using baseline depressive symptoms: (1) Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥20 (n = 132); (2) Clinical Global Impression for Bipolar Disorder-Depression (CGI-BP-D) scale severity score ≥4 (n = 170); (3) diagnosis of mixed episodes (n = 302) by investigative site screening. For each population, asenapine and olanzapine were independently compared with placebo using least squares mean change from baseline on depressive symptom measures. Decreases in MADRS total score were statistically greater with asenapine versus placebo at days 7 and 21 in all populations; differences between olanzapine and placebo were not significant. Decreases in CGI-BP-D score were significantly greater with asenapine versus placebo at day 7 in all categories and day 21 in population 1; CGI-BP-D score reductions were significantly greater with olanzapine versus placebo at day 21 in population 1 and day 7 in populations 2 and 3. These post hoc analyses show that asenapine reduced depressive symptoms in bipolar I disorder patients experiencing acute manic or mixed episodes with clinically relevant depressive symptoms at baseline; olanzapine results appeared to be less consistent. Controlled studies of asenapine in patients with acute bipolar depression are necessary to

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

    ERIC Educational Resources Information Center

    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…

  16. Evaluation of Post-Arrival Programs and Services.

    ERIC Educational Resources Information Center

    Australian Inst. of Multicultural Affairs, Melbourne (Australia).

    This book assesses the effectiveness of recommendations implemented after the release of the Australian government's "Report of the Review of Post-Arrival Programs and Services for Migrants" in 1977. In general, the implementation of the Report's proposals has been of substantial benefit to migrants (both newly arrived and longer…

  17. Designing and Evaluating Learning Collaborations in Post-Secondary Geography

    ERIC Educational Resources Information Center

    Ray, Waverly C.

    2009-01-01

    The Association of American Geographers' Center for Global Geography Education (CGGE) offers online learning modules that support international collaborations in post-secondary geography with the aim of promoting international dialogue on relevant geographic issues. Through the module's collaborative learning activities, students have an…

  18. Evaluation of Post-Arrival Programs and Services.

    ERIC Educational Resources Information Center

    Australian Inst. of Multicultural Affairs, Melbourne (Australia).

    This book assesses the effectiveness of recommendations implemented after the release of the Australian government's "Report of the Review of Post-Arrival Programs and Services for Migrants" in 1977. In general, the implementation of the Report's proposals has been of substantial benefit to migrants (both newly arrived and longer…

  19. Post Secondary Correctional Education: An Evaluation of Parolee Performance.

    ERIC Educational Resources Information Center

    Holloway, Jerry; Moke, Paul

    Wilmington College (Ohio) conducted a study to determine if receiving college training during incarceration enhances offenders' post-release behavior. Three hundred residents of Lebanon Correctional Institution in Ohio, a medium-security prison for adults under 30, were studied. Of the group, 95 received associates degrees while in prison. These…

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

    ERIC Educational Resources Information Center

    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…

  1. Evaluating the Impact of Guest Speaker Postings in Online Discussions

    ERIC Educational Resources Information Center

    Hemphill, Leaunda S.; Hemphill, Hoyet H.

    2007-01-01

    This study investigated the impact of virtual guest speakers facilitating asynchronous discussions. The setting was an online instructional technology course with 16 graduate students and two guest speakers. The research reports the quantity and level of critical thinking of the students and guests. Each posting was coded for frequency and…

  2. An open trial evaluating an attention bias modification program for overweight adults who binge eat.

    PubMed

    Boutelle, Kerri N; Monreal, Teresa; Strong, David R; Amir, Nader

    2016-09-01

    Binge eating is prevalent and is associated with significant psychiatric and medical comorbidities. To date, the most effective psychological treatments for individuals who binge eat are not effective for all patients and they do not result in significant weight loss. Dual process theories suggest that implicit factors, such as attention bias, may influence behavior, even when the behavior is in opposition to long-term goals. Attention bias modification programs have been tested in other areas of psychopathology, and could be utilized to improve outcomes for people who binge eat. Thus, the aim of this open trial was to conduct a preliminary evaluation of an attention bias modification program (ABM-Food) designed to train attention away from food cues. Adults who binge eat and were overweight or obese enrolled in an 8-week ABM-Food program, which consisted of one session in the lab each week and two training sessions at home. Nine participants completed the ABM-Food training program and the post-treatment assessment, and 8 completed the 3-month post-treatment assessment. Results showed that the ABM-Food program is a feasible and acceptable treatment for adults who binge eat. Initial effectiveness data showed decreases in weight, eating disorder symptoms, binge eating, loss of control and responsivity to food in the environment, as well as changes in attention bias. The majority of these effects remained at the 3-month follow-up time point. This study is limited by the single-group open label trial, and the small sample size. This open trial provides initial evidence for the feasibility, acceptability and effectiveness of ABM-Food for individuals who binge eat and are overweight or obese. Copyright © 2016. Published by Elsevier Ltd.

  3. Effect of Sodium Phosphate Supplementation on Cycling Time Trial Performance and VO2 1 and 8 Days Post Loading.

    PubMed

    Brewer, Cameron P; Dawson, Brian; Wallman, Karen E; Guelfi, Kym J

    2014-09-01

    This study examined the effect of 6 days of sodium phosphate (SP) (50 mg·kg·FFM(-1)·day(-1)) or placebo (PL) supplementation in trained cyclists on either 100 kJ (23.9 Kcal) (~3-4 min) or 250 kJ (59.7 Kcal) (~10-12 min) time trials performances both 1 and 8 days post-supplementation. Trials were performed in a counterbalanced crossover design, with a 28-day washout period between supplementation phases. No significant differences, moderate-large ES (d) or likely (or greater) smallest worthwhile change (SWC) values were recorded for time to completion and mean power output on days 1 and 8 post-supplementation, both within and between SP and PL for either the 100 or 250 kJ (23.9 or 59.7 Kcal) trials. In the 100 kJ (23.9 Kcal) trial (only) first minute VO2 tended to be higher in SP8 than both PL8 (d = 0.60; 88/10/2 SWC) and SP1 (d = 0.47: 82/15/3 SWC), as was mean VO2 (PL8: d = 0.77; 93/6/1 SWC and SP1: d = 0.84; 90/8/3 SWC). No significant differences were found for heart rate, ratings of perceived exertion and blood lactate post-exercise within or between any trials, while serum phosphate values were not different before or after supplementation with SP or PL. In conclusion, this study showed a tendency for increased VO2 in a short duration (100 kJ/ 23.9 Kcal: ~3-4 min) cycling test on day 8 after SP supplementation, but no differences in 100 or 250 kJ (23.9 or 59.7 Kcal) time trials performances were observed. Key PointsStudies investigating the effects of sodium phosphate loading on shorter duration (<15 min) and higher intensity exercise performance are lacking, as is research on how long any ergogenic effect may last.Loading did not improve cycling time trial (~3-4 min and 10-12 min) performance either 1 or 8 days after supplementation.Future studies should investigate the effect of sodium phosphate loading on repeated sprints and simulated cycling road race performance over extended durations (>30 min), where it may be likely to have a more beneficial effect.

  4. A randomised trial evaluating anakinra in early active rheumatoid arthritis.

    PubMed

    Scott, Ian C; Ibrahim, Fowzia; Simpson, Gemma; Kowalczyk, Anna; White-Alao, Beverley; Hassell, Andrew; Plant, Michael; Richards, Selwyn; Walker, David; Scott, David L

    2016-01-01

    The effectiveness of anakinra (interleukin-1 receptor antagonist) in early rheumatoid arthritis (RA) is unknown. We evaluated the efficacy of anakinra (combined with methotrexate) in a randomised clinical trial of early active RA patients. The Combination Anti-Rheumatic Drugs in Early RA-2 (CARDERA-2) trial was a randomised trial of early (duration <1 year) active RA. Patients were randomised to 12 months of: (1) methotrexate or (2) anakinra-methotrexate. Follow-up lasted 2 years. The primary outcome was erosive progression (changes from baseline in modified Larsen scores). Secondary outcomes were changes from baseline in disease activity score on a 28-joint count (DAS28), health assessment questionnaire (HAQ), and quality of life (EQ-5D) scores alongside ACR responder rates. 154 patients received the allocated intervention (from 259 screened). Similar Larsen score progression was seen at 12 and 24 months in patients receiving anakinra-methotrexate (mean changes from baseline of 2.50 and 5.10, respectively) and methotrexate monotherapy (mean changes from baseline of 4.16 and 5.20, respectively). Lower improvements in DAS28 and HAQ scores were seen at all time-points in anakinra-methotrexate treated patients; these were significantly less at 24 months (DAS28 p=0.04; HAQ P=0.02). Significantly lower EQ-5D score increases were seen at 12 months with anakinra-methotrexate (p=0.03). Anakinra-methotrexate was associated with more serious adverse events compared with methotrexate monotherapy (11 vs. 6 patients), although this was not significant (p=0.59). Anakinra (combined with methotrexate) is not effective in early, active RA. It provided no clinical benefits beyond methotrexate monotherapy.

  5. The Effectiveness of Pregabalin for Post-Tonsillectomy Pain Control: A Randomized Controlled Trial

    PubMed Central

    Park, Soo Seog; Kim, Dong-Hyun; Nam, In-Chul; Lee, Il-Hwan; Hwang, Jae-Woong

    2015-01-01

    Background Although various analgesics have been used, postoperative pain remains one of the most troublesome aspects of tonsillectomy for patients. Objective The aim of the present study was to evaluate the effectiveness of premedication using pregabalin compared with placebo (diazepam) on postoperative pain control in patients undergoing tonsillectomy. Methods Forty-eight adult patients were randomly divided into a control group and a pregabalin group. Preoperatively, patients in the control group received 4 mg diazepam orally as placebo, whereas those in the pregabalin group received 300 mg pregabalin orally. All participants were provided with patient-controlled analgesia using fentanyl for 24 hours after surgery. Postoperative pain treatment included acetaminophen 650 mg three times daily for 8 postoperative days. The primary outcome measure was the total amount of patient-controlled fentanyl consumption after tonsillectomy. Secondary outcome measures were the number of injections of ketorolac tromethamine (each 30 mg) requested by patients, pain scores, overall satisfaction scores, drowsiness, nausea, dizziness, headache, and vomiting after the surgery. P < 0.05 was considered statistically significant. Results The total amount of fentanyl demanded decreased significantly in the pregabalin group (P < 0.001). There were no significant differences in the number of ketorolac tromethamine injections, pain scores, overall satisfaction scores, drowsiness, nausea, dizziness, headache, and vomiting between the two groups. Conclusion Administration of 300 mg pregabalin prior to tonsillectomy decreases fentanyl consumption compared with that after 4 mg diazepam, without an increased incidence of adverse effects. Trial Registration KCT0001215 PMID:25706948

  6. Honey Versus Diphenhydramine for Post-Tonsillectomy Pain Relief in Pediatric Cases: A Randomized Clinical Trial

    PubMed Central

    Amani, Soroush; Kheiri, Soleyman

    2015-01-01

    Introduction: Tonsillectomy is one of the most common surgeries done worldwide and often the first one a child sustains. Pain relief after tonsillectomy is helpful for oral feeding after surgery. Acetaminophen and diphenhydramine have been conventionally used for reducing pain. This study was conducted to compare the effect of honey and diphehydramine on pain relief after tonsillectomy. Materials and Methods: For this randomized clinical trial study, 120 patients of 5 to 12 years undergoing tonsillectomy were recruited. The patients were divided into four groups randomly. After tonsillectomy and beginning of eating, Group A took 5cc honey alone every hour, Group B was given 5 cc 50% honey (mixed with water) every hour, group C was treated with 1mg/kg diphenhydramine every 6 hours and group D was observed without any intervention. In all patients, severity of the pain was evaluated by ocher questionnaire at recovery, and 3, 6, 12 and 24 hours after surgery. The data were analyzed using ANOVA and the repeated measures ANOVA (SPSS version 17). Results: The repeated ANOVA showed a significant decreasing trend of pain scores during the study for both pain scales (p <0.05), but the rate of trend was similar between the four groups (p > 0.05). No statistically significant difference in pain was detected among the groups. Conclusion: Although honey can help the pain decrease, more research is supported for confirmation of this effect. PMID:25954673

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

    PubMed

    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.

  8. Suppository naproxen reduces incidence and severity of post-endoscopic retrograde cholangiopancreatography pancreatitis: Randomized controlled trial.

    PubMed

    Mansour-Ghanaei, Fariborz; Joukar, Farahnaz; Taherzadeh, Zahra; Sokhanvar, Homayoon; Hasandokht, Tolou

    2016-06-07

    To determine the efficacy of rectally administered naproxen for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). This double-blind randomized control trial conducted from January 2013 to April 2014 at the Gastrointestinal and Liver Diseases Research Center in Rasht, Iran. A total of 324 patients were selected from candidates for diagnostic or therapeutic ERCP by using the simple sampling method. Patients received a single dose of Naproxen (500 mg; n = 162) or a placebo (n = 162) per rectum immediately before ERCP. The overall incidence of PEP, incidence of mild to severe PEP, serum amylase levels and adverse effects were measured. The primary outcome measure was the development of pancreatitis onset of pain in the upper abdomen and elevation of the serum amylase level to > 3 × the upper normal limit (60-100 IU/L) within 24 h after ERCP. The severity of PEP was classified according to the duration of therapeutic intervention for PEP: mild, 2-3 d; moderate 4-10 d; and severe, > 10 d and/or necessitated surgical or intensive treatment, or contributed to death. PEP occurred in 12% (40/324) of participants, and was significantly more frequent in the placebo group compared to the naproxen group (P < 0.01). Of the participants, 25.9% (84/324) developed hyperamylasemia within 2 h of procedure completion, among whom only 35 cases belonged to the naproxen group (P < 0.01). The incidence of PEP was significantly higher in female sex, in patients receiving pancreatic duct injection, more than 3 times pancreatic duct cannulations, and ERCP duration more than 40 min (Ps < 0.01). There were no statistically significant differences between the groups regarding the procedures or factors that might increase the risk of PEP, sphincterotomy, precut requirement, biliary duct injection and number of pancreatic duct cannulations. In the subgroup of patients with pancreatic duct injection, the rate of pancreatitis in the naproxen group was

  9. Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination.

    PubMed

    Williams, Rebecca J; Tse, Tony; DiPiazza, Katelyn; Zarin, Deborah A

    2015-01-01

    Clinical trials that end prematurely (or "terminate") raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized. A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial. Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study.

  10. Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination

    PubMed Central

    Williams, Rebecca J.; Tse, Tony; DiPiazza, Katelyn; Zarin, Deborah A.

    2015-01-01

    Background Clinical trials that end prematurely (or “terminate”) raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized. Methods and Findings A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial. Conclusions Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study

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

    PubMed Central

    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

  12. Anterior cruciate ligament- specialized post-operative return-to-sports (ACL-SPORTS) training: a randomized control trial

    PubMed Central

    2013-01-01

    Background Anterior cruciate ligament reconstruction (ACLR) is standard practice for athletes that wish to return to high-level activities; however functional outcomes after ACLR are poor. Quadriceps strength weakness, abnormal movement patterns and below normal knee function is reported in the months and years after ACLR. Second ACL injuries are common with even worse outcomes than primary ACLR. Modifiable limb-to-limb asymmetries have been identified in individuals who re-injure after primary ACLR, suggesting a neuromuscular training program is needed to improve post-operative outcomes. Pre-operative perturbation training, a neuromuscular training program, has been successful at improving limb symmetry prior to surgery, though benefits are not lasting after surgery. Implementing perturbation training after surgery may be successful in addressing post-operative deficits that contribute to poor functional outcomes and second ACL injury risk. Methods/Design 80 athletes that have undergone a unilateral ACLR and wish to return to level 1 or 2 activities will be recruited for this study and randomized to one of two treatment groups. A standard care group will receive prevention exercises, quadriceps strengthening and agility exercises, while the perturbation group will receive the same exercise program with the addition of perturbation training. The primary outcomes measures will include gait biomechanics, clinical and functional measures, and knee joint loading. Return to sport rates, return to pre-injury level of activity rates, and second injury rates will be secondary measures. Discussion The results of this ACL-Specialized Post-Operative Return To Sports (ACL-SPORTS) Training program will help clinicians to better determine an effective post-operative treatment program that will improve modifiable impairments that influence outcomes after ACLR. Trial registration Randomized Control Trial NIH 5R01AR048212-07. ClinicalTrials.gov: NCT01773317 PMID:23522373

  13. [LAPTOP trial--results of an health economics evaluation].

    PubMed

    Dippel, F-W

    2008-08-01

    Based on the LAPTOP trial, a cost and a benefit assessment were undertaken. The cost analysis was performed as a desk-top evaluation using the cost minimization method. The benefit assessment was done as a simulation using the diabetes mellitus model (DMM). In each analysis either cost or benefit of treating diabetes mellitus with oral antidiabetic drug(s) supported by insulin glargine were compared to those with conventional insulin treatment using premixed insulin twice daily. The cost benefit analysis demonstrated that treatment with insulin glargine plus oral antidiabetics was less expensive than the conventional insulin treatment with premixed insulin. Furthermore, avoidance of diabetic complications was better with insulin glargine plus oral antidiabetics than with premixed insulin alone.

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

    PubMed

    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.

  15. Electromyographic assessment of dexamethasone in treatment of post-tonsillectomy pain: randomized, placebo-controlled trial.

    PubMed

    Vaiman, Michael; Aviram, Eliad; Krakovski, Daniel; Gavriel, Haim; Eviatar, Ephraim

    2011-06-01

    Surface electromyographic (sEMG) study of post-tonsillectomy swallow-evoked muscular reactions was performed to assess analgesic properties of dexamethasone. Sixty randomly chosen operated adults were divided into 2 groups. Group 1 (n = 30) was treated with dexamethasone (Dexacort, 20 mg); group 2 (n = 30) was treated with placebo. Pain assessment included visual analogue scale (VAS) pain score and the EMG data such as the timing, electric amplitude and graphic patterns of muscular activity during deglutition. We investigated masseter, infrahyoid and submental-submandibular muscles. Records from trapezius muscle were used for control. The results were compared with previously established normative database. The sEMG data were compared with VAS pain score with regard to changes in clinical condition of the patients. Surface EMG signs of analgesia after tonsillectomy did not always correspond with the VAS pain score. Dexamethasone normalizes muscular activity in deglutition as detected by the EMG records. Statistically significant difference in muscle reactions was detected between the 2 groups. If dexamethasone is administered, the reduction of the postoperative pain could be secondary to the reduction of edema. The sEMG might be used for quantitative evaluation of analgesics via assessment of neuromuscular reactions to analgesia.

  16. Medical self-care education for elders: a controlled trial to evaluate impact.

    PubMed Central

    Nelson, E C; McHugo, G; Schnurr, P; Devito, C; Roberts, E; Simmons, J; Zubkoff, W

    1984-01-01

    We conducted a trial to evaluate the impact of medical self-care education on 330 elders whose average age was 71. The test group participated in a 13-session educational intervention with training in clinical medicine, life-style, and use of health services. The comparison group received a two-hour lecture-demonstration. Both groups were assessed pre-intervention, post-intervention, and one year after entry. The results indicate medical self-care instruction: produces substantial improvements, that were sustained for one year, in health knowledge, skills performance, and skills confidence; stimulates many attempts to improve life-style; and generates improvements in life quality. The program had little influence on utilization of medical care or health status. PMID:6507688

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

    PubMed

    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.

  18. Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review

    PubMed Central

    Sofaer, Neema; Strech, Daniel

    2011-01-01

    Background: researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug and the uses of such reasons. Data sources: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications’ notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. Results: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason’s interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. Limitations: reason types could be applied differently. The quality of reasons was not measured. Conclusion: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature. PMID:21754950

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

    PubMed

    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.

  20. A tale of two trials: a comparison of the post-acute coronary syndrome lipid-lowering trials A to Z and PROVE IT-TIMI 22.

    PubMed

    Wiviott, Stephen D; de Lemos, James A; Cannon, Christopher P; Blazing, Michael; Murphy, Sabina A; McCabe, Carolyn H; Califf, Robert; Braunwald, Eugene

    2006-03-21

    The Aggrastat to Zocor (A to Z) and Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT) trials compared intensive and moderate statin therapy after acute coronary syndromes, with seemingly disparate results. We analyzed the design, implementation, and results of the two trials in an attempt to clarify the effects of early intensive statin therapy. Study design, end points, and definitions were compared. In each trial, comparisons were made between intensive and moderate arms for both trials' primary end points and death/myocardial infarction. Analyses were performed over various time points: at the end of the trials, < or =4 months, and >4 months. Subjects in A to Z had higher-risk demographics. More PROVE IT subjects were enrolled in the United States and underwent prerandomization revascularization. The low-density lipoprotein (LDL) difference was greater in A to Z than in PROVE IT early (< or =4 months) but less late. Significant C-reactive protein reduction was earlier in PROVE IT. With common end points, event rates were higher in A to Z, and early favorable separation of event curves was seen in PROVE IT but not in A to Z. Clinical end point rates and reductions were similar in both trials after 4 months. An early benefit was seen in PROVE IT but not in A to Z. Late-phase results were similar. Factors that may explain this disparity include the intensity of therapy in the early phase, timing, and magnitude of LDL and C-reactive protein lowering, differences in early revascularization, and the play of chance. Taken together, the results of these trials support a strategy of early intensive statin therapy coupled with revascularization when appropriate in patients after acute coronary syndrome.

  1. Randomised Trial Evaluation of the In:tuition Programme

    ERIC Educational Resources Information Center

    Lynch, Sarah; Styles, Ben; Poet, Helen; White, Richard; Bradshaw, Sally; Rabiasz, Adam

    2015-01-01

    This summary reports the findings from two cluster-randomised trials of Drinkaware's school-based In:tuition life skills and alcohol education intervention: one trial of the programme for 10-11 year olds in primary schools, and another for 12-13 year olds in secondary schools. The trials have been carried out by the National Foundation for…

  2. Clinical trials in peripheral vascular disease: pipeline and trial designs: an evaluation of the ClinicalTrials.gov database.

    PubMed

    Subherwal, Sumeet; Patel, Manesh R; Chiswell, Karen; Tidemann-Miller, Beth A; Jones, W Schuyler; Conte, Michael S; White, Christopher J; Bhatt, Deepak L; Laird, John R; Hiatt, William R; Tasneem, Asba; Califf, Robert M

    2014-11-11

    Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); until recently, however, it has not been possible to examine the entire clinical trial portfolio of studies for the treatment of PVD (both arterial and venous disease). We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower-extremity peripheral artery disease and acute stroke (35% and 24%, respectively), whereas most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients >65 years of age. Enrollment in at least 1 US site decreased from 51% of trials in 2007 to 41% in 2010. Compared with noncardiology disciplines, PVD trials were more likely to be double-blinded, to investigate the use of devices and procedures, and to have industry sponsorship and assumed funding source, and they were less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD. © 2014 American Heart Association, Inc.

  3. Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database

    PubMed Central

    Subherwal, Sumeet; Patel, Manesh R.; Chiswell, Karen; Tidemann-Miller, Beth A.; Jones, W. Schuyler; Conte, Michael S.; White, Christopher J.; Bhatt, Deepak L.; Laird, John R.; Hiatt, William R.; Tasneem, Asba; Califf, Robert M.

    2014-01-01

    Background Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); however, until recently it has not been possible to examine the entire clinical trial portfolio of studies for treatment of PVD (both arterial and venous disease). Methods and Results We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower extremity peripheral artery disease and acute stroke (35% and 24%, respectively), while most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients aged >65 years. Enrollment in at least 1 US site decreased from 51% in 2007 to 41% of trials in 2010. Compared with non-cardiology disciplines, PVD trials were more likely to be double-blinded, investigate use of devices and procedures, and have industry sponsorship and assumed funding source, and less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. Conclusions PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD. PMID:25239436

  4. Telavancin for Acute Bacterial Skin and Skin Structure Infections, a Post Hoc Analysis of the Phase 3 ATLAS Trials in Light of the 2013 FDA Guidance

    PubMed Central

    Pushkin, Richard; Barriere, Steven L.; Corey, G. Ralph; Stryjewski, Martin E.

    2015-01-01

    Two phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. This post hoc analysis included patients with lesion sizes of ≥75 cm2 and excluded patients with ulcers or burns (updated all-treated population; n = 1,127). Updated day 3 (early) clinical response was defined as a ≥20% reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as a ≥90% reduction in lesion size, no increase in lesion size since day 3, and no requirement for additional antibiotics or significant surgical procedures. Day 3 (early) clinical responses were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin, respectively (difference, 1.7%, with a 95% confidence interval [CI] of −4.0% to 7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and vancomycin (63.3%), with a difference of 4.8% (95% CI, −0.7% to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin. PMID:26248356

  5. Telavancin for Acute Bacterial Skin and Skin Structure Infections, a Post Hoc Analysis of the Phase 3 ATLAS Trials in Light of the 2013 FDA Guidance.

    PubMed

    Pushkin, Richard; Barriere, Steven L; Wang, Whedy; Corey, G Ralph; Stryjewski, Martin E

    2015-10-01

    Two phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. This post hoc analysis included patients with lesion sizes of ≥75 cm(2) and excluded patients with ulcers or burns (updated all-treated population; n = 1,127). Updated day 3 (early) clinical response was defined as a ≥20% reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as a ≥90% reduction in lesion size, no increase in lesion size since day 3, and no requirement for additional antibiotics or significant surgical procedures. Day 3 (early) clinical responses were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin, respectively (difference, 1.7%, with a 95% confidence interval [CI] of -4.0% to 7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and vancomycin (63.3%), with a difference of 4.8% (95% CI, -0.7% to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin.

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

    EPA Science Inventory

    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...

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

    EPA Science Inventory

    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...

  8. Application of System Identification Techniques to Turbine Engine Post-Stall Test and Evaluation. Volume 1

    DTIC Science & Technology

    1990-12-01

    Application of System Identification Techniques to Turbine Engine Post-Stall Test and Evaluation was an Air Force funded study to investigate and...apply system identification techniques to post-stall engine models in a manner which allowed AEDC personnel to become proficient in the use of these

  9. Repeat Post-Op Voiding Trials: An Inconvenient Correlate with Success

    PubMed Central

    Ferrante, K.L.; Kim, H-Y.; Brubaker, L.; Wai, C.Y.; Norton, P.; Kraus, S.R.; Shepherd, J.; Sirls, L.T.; Nager, C.W.

    2014-01-01

    AIMS This study examined the association between the need for a repeat voiding trial after midurethral sling (MUS) surgery and 1-year success rates. METHODS We conducted this secondary analysis of the participants in the Urinary Incontinence Treatment Network Trial Of Midurethral Sling (TOMUS) study which compared retropubic vs. transobturator MUS. A standard voiding trial was attempted on all subjects. The ‘repeat voiding trial’ group included subjects discharged with catheterization. All others were considered ‘self voiding’. Success rates between the groups at 1 year were compared, followed by multivariate analyses controlling for previously reported clinical predictors of success. RESULTS Most women (76%) were self-voiding, while 24% required a repeat voiding trial. The objective success rate at 1 year was 85.8% in the repeat voiding trial group and 75.3% in the self-voiding group (p=0.01). Subjective success rate at 1 year was 61.0% in the repeat voiding trial group and 55.1% in the self-voiding group (p=0.23). Women in the repeat voiding trial group continued to demonstrate greater objective success than the self-voiding group in multivariate analysis that controlled for previous incontinence surgery, pad weight, urethral mobility, urge score and type of MUS (p=0.04, OR 1.82, 95% CI 1.03-3.22). CONCLUSIONS Women who require a repeat voiding trial following MUS surgery have greater objective success at 1 year postoperatively when compared to those who are self-voiding at the time of discharge. These results may help reassure women who require catheterization after MUS surgery that their outcome is not compromised by this immediate transient postoperative result. PMID:23983149

  10. Le post mortem d'une evaluation conjecturelle.

    ERIC Educational Resources Information Center

    Hurteau, Marthe; Nadeau, Marc-Andre

    1987-01-01

    A responsive model of evaluation was used for program evaluation in a French-speaking university. Two objectives were addressed: determining the local utility of the program being assessed and identifying the advantages and limits of the model and comparing them to those reported in the literature. (RB)

  11. Library Design Analysis Using Post-Occupancy Evaluation Methods.

    ERIC Educational Resources Information Center

    James, Dennis C.; Stewart, Sharon L.

    1995-01-01

    Presents findings of a user-based study of the interior of Rodger's Science and Engineering Library at the University of Alabama. Compared facility evaluations from faculty, library staff, and graduate and undergraduate students. Features evaluated include: acoustics, aesthetics, book stacks, design, finishes/materials, furniture, lighting,…

  12. Selective prevention of combat-related post-traumatic stress disorder using attention bias modification training: a randomized controlled trial.

    PubMed

    Wald, I; Fruchter, E; Ginat, K; Stolin, E; Dagan, D; Bliese, P D; Quartana, P J; Sipos, M L; Pine, D S; Bar-Haim, Y

    2016-09-01

    Efficacy of pre-trauma prevention for post-traumatic stress disorder (PTSD) has not yet been established in a randomized controlled trial. Attention bias modification training (ABMT), a computerized intervention, is thought to mitigate stress-related symptoms by targeting disruptions in threat monitoring. We examined the efficacy of ABMT delivered before combat in mitigating risk for PTSD following combat. We conducted a double-blind, four-arm randomized controlled trial of 719 infantry soldiers to compare the efficacy of eight sessions of ABMT (n = 179), four sessions of ABMT (n = 184), four sessions of attention control training (ACT; n = 180), or no-training control (n = 176). Outcome symptoms were measured at baseline, 6-month follow-up, 10 days following combat exposure, and 4 months following combat. Primary outcome was PTSD prevalence 4 months post-combat determined in a clinical interview using the Clinician-Administered PTSD Scale. Secondary outcomes were self-reported PTSD and depression symptoms, collected at all four assessments. PTSD prevalence 4 months post-combat was 7.8% in the no-training control group, 6.7% with eight-session ABMT, 2.6% with four-session ABMT, and 5% with ACT. Four sessions of ABMT reduced risk for PTSD relative to the no-training condition (odds ratio 3.13, 95% confidence interval 1.01-9.22, p < 0.05, number needed to treat = 19.2). No other between-group differences were found. The results were consistent across a variety of analytic techniques and data imputation approaches. Four sessions of ABMT, delivered prior to combat deployment, mitigated PTSD risk following combat exposure. Given its low cost and high scalability potential, and observed number needed to treat, research into larger-scale applications is warranted. The ClinicalTrials.gov identifier is NCT01723215.

  13. Randomized Clinical Trial of Motivational Enhancement of Substance Use Treatment among Incarcerated Adolescents: Post-Release Condom Non-Use

    ERIC Educational Resources Information Center

    Rosengard, Cynthia; Stein, L. A. R.; Barnett, Nancy P.; Monti, Peter M.; Golembeske, Charles; Lebeau-Craven, Rebecca; Miranda, Robert

    2007-01-01

    Evaluated impact of motivational enhancement (ME) of substance abuse treatment compared to relaxation training (RT) on sex without condoms (overall and involving substance use) 3 months following release among incarcerated adolescents. This randomized clinical trial involved 114 incarcerated adolescents from the Northeast. Regression analyses…

  14. Randomized Clinical Trial of Motivational Enhancement of Substance Use Treatment among Incarcerated Adolescents: Post-Release Condom Non-Use

    ERIC Educational Resources Information Center

    Rosengard, Cynthia; Stein, L. A. R.; Barnett, Nancy P.; Monti, Peter M.; Golembeske, Charles; Lebeau-Craven, Rebecca; Miranda, Robert

    2007-01-01

    Evaluated impact of motivational enhancement (ME) of substance abuse treatment compared to relaxation training (RT) on sex without condoms (overall and involving substance use) 3 months following release among incarcerated adolescents. This randomized clinical trial involved 114 incarcerated adolescents from the Northeast. Regression analyses…

  15. Post-Occupancy Evaluation (POE) Methodologies for School Facilities: A Case Study of the V. Sue Cleveland High School Post Occupancy Evaluation

    ERIC Educational Resources Information Center

    Harmon, Marcel; Larroque, Andre; Maniktala, Nate

    2012-01-01

    The New Mexico Public School Facilities Authority (NMPSFA) is the agency responsible for administering state-funded capital projects for schools statewide. Post occupancy evaluation (POE) is the tool selected by NMPSFA for measuring project outcomes. The basic POE process for V. Sue Cleveland High School (VSCHS) consisted of a series of field…

  16. Post-Occupancy Evaluation (POE) Methodologies for School Facilities: A Case Study of the V. Sue Cleveland High School Post Occupancy Evaluation

    ERIC Educational Resources Information Center

    Harmon, Marcel; Larroque, Andre; Maniktala, Nate

    2012-01-01

    The New Mexico Public School Facilities Authority (NMPSFA) is the agency responsible for administering state-funded capital projects for schools statewide. Post occupancy evaluation (POE) is the tool selected by NMPSFA for measuring project outcomes. The basic POE process for V. Sue Cleveland High School (VSCHS) consisted of a series of field…

  17. Detection and Prevention of Post-Operative Deep Vein Thrombosis [DVT] Using Nadroparin Among Patients Undergoing Major Abdominal Operations in India; a Randomised Controlled Trial.

    PubMed

    Murugesan, Anandan; Srivastava, Dina N; Ballehaninna, Uma K; Chumber, Sunil; Dhar, Anita; Misra, Mahesh C; Parshad, Rajinder; Seenu, V; Srivastava, Anurag; Gupta, Narmada P

    2010-08-01

    Deep vein thrombosis [DVT] is one of the most dreaded complications in post-operative patients as it is associated with considerable morbidity and mortality. Majority of patients with postoperative DVT are asymptomatic. The pulmonary embolism, which is seen in 10% of the cases with proximal DVT, may be fatal. Therefore it becomes imperative to prevent DVT rather than to diagnose and treat. Only one randomized trial has been reported from India to assess the effectiveness of low molecular weight heparin in preventing post-operative DVT. To assess the risk of DVT in North Indian patients following major abdominal operations and to evaluate the effectiveness of Nadroparin, A Low Molecular Weight Heparin (LMWH) therapy in preventing post-operative DVT. Sixty five patients were randomised preoperatively into Group-I; Nadroparin prophylaxis and Group-II: No prophylaxis. The primary outcome was the occurrence of DVT, diagnosed by bilateral lower limb venogram performed, seven to ten days after operation. Secondary outcome measures included adverse effects of radio-opaque dye, intra-operative blood loss, operating time, postoperative platelet count, intraoperative blood transfusion requirements and the total duration of postoperative bed rest. No case of DVT occurred in either group. There was no statistical difference in the risk of secondary outcome measures in the two groups. DVT was not observed in any of the patients, even with several high risk factors indicating a possible protective mechanism in the North Indian population.

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

    PubMed

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

    2012-04-01

    To assess the effect of peritonsillar infiltration of ketamine and tramadol on post tonsillectomy pain and compare the side effects. 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. 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. Preoperative peritonsillar infiltration of tramadol can decrease post-tonsillectomy pain, analgesic consumption, and the time to recovery without significant side effects.

  19. A pilot randomized controlled trial examining the feasibility, acceptability, and efficacy of Adapted Motivational Interviewing for post-operative bariatric surgery patients.

    PubMed

    David, Lauren A; Sockalingam, Sanjeev; Wnuk, Susan; Cassin, Stephanie E

    2016-08-01

    Non-adherence to post-operative dietary guidelines contributes to poorer outcomes following bariatric surgery. The current pilot study evaluated the impact of Adapted Motivational Interviewing (AMI) on patients' readiness for change, self-efficacy, and adherence to dietary guidelines following bariatric surgery. A randomized wait-list controlled trial was conducted. Post-operative bariatric patients (N=51) were randomly allocated to receive the single session AMI intervention either immediately (AMI group; n=23), or in 12weeks while continuing to receive standard bariatric care (wait list control [WLC] group; n=28). Completer analyses (n=44) indicated that participants reported improvements in readiness, confidence, and self-efficacy for change immediately following the AMI intervention. They also reported improvements in binge eating symptomatology and some measures of dietary adherence across the 12-week follow-up period. Significant Group×Time interactions for confidence for change, dietary adherence, and binge eating symptomatology suggest that the AMI group improved on these outcomes whereas the control group did not. These preliminary findings suggest that AMI is an acceptable and feasible intervention with the potential to improve bariatric patients' confidence for change and eating behaviors. Future research should examine these results in comparison to routinely collected postsurgery follow-up data to learn more about AMI's efficacy for improving post-surgical adherence. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. Randomised field trial to evaluate serological response after foot-and-mouth disease vaccination in Turkey

    PubMed Central

    Knight-Jones, T.J.D.; Bulut, A.N.; Gubbins, S.; Stärk, K.D.C.; Pfeiffer, D.U.; Sumption, K.J.; Paton, D.J.

    2015-01-01

    Despite years of biannual mass vaccination of cattle, foot-and-mouth disease (FMD) remains uncontrolled in Anatolian Turkey. To evaluate protection after mass vaccination we measured post-vaccination antibodies in a cohort of cattle (serotypes O, A and Asia-1). To obtain results reflecting typical field protection, participants were randomly sampled from across Central and Western Turkey after routine vaccination. Giving two-doses one month apart is recommended when cattle are first vaccinated against FMD. However, due to cost and logistics, this is not routinely performed in Turkey, and elsewhere. Nested within the cohort, we conducted a randomised trial comparing post-vaccination antibodies after a single-dose versus a two-dose primary vaccination course. Four to five months after vaccination, only a third of single-vaccinated cattle had antibody levels above a threshold associated with protection. A third never reached this threshold, even at peak response one month after vaccination. It was not until animals had received three vaccine doses in their lifetime, vaccinating every six months, that most (64% to 86% depending on serotype) maintained antibody levels above this threshold. By this time cattle would be >20 months old with almost half the population below this age. Consequently, many vaccinated animals will be unprotected for much of the year. Compared to a single-dose, a primary vaccination course of two-doses greatly improved the level and duration of immunity. We concluded that the FMD vaccination programme in Anatolian Turkey did not produce the high levels of immunity required. Higher potency vaccines are now used throughout Turkey, with a two-dose primary course in certain areas. Monitoring post-vaccination serology is an important component of evaluation for FMD vaccination programmes. However, consideration must be given to which antigens are present in the test, the vaccine and the field virus. Differences between these antigens affect the

  1. Randomised field trial to evaluate serological response after foot-and-mouth disease vaccination in Turkey.

    PubMed

    Knight-Jones, T J D; Bulut, A N; Gubbins, S; Stärk, K D C; Pfeiffer, D U; Sumption, K J; Paton, D J

    2015-02-04

    Despite years of biannual mass vaccination of cattle, foot-and-mouth disease (FMD) remains uncontrolled in Anatolian Turkey. To evaluate protection after mass vaccination we measured post-vaccination antibodies in a cohort of cattle (serotypes O, A and Asia-1). To obtain results reflecting typical field protection, participants were randomly sampled from across Central and Western Turkey after routine vaccination. Giving two-doses one month apart is recommended when cattle are first vaccinated against FMD. However, due to cost and logistics, this is not routinely performed in Turkey, and elsewhere. Nested within the cohort, we conducted a randomised trial comparing post-vaccination antibodies after a single-dose versus a two-dose primary vaccination course. Four to five months after vaccination, only a third of single-vaccinated cattle had antibody levels above a threshold associated with protection. A third never reached this threshold, even at peak response one month after vaccination. It was not until animals had received three vaccine doses in their lifetime, vaccinating every six months, that most (64% to 86% depending on serotype) maintained antibody levels above this threshold. By this time cattle would be >20 months old with almost half the population below this age. Consequently, many vaccinated animals will be unprotected for much of the year. Compared to a single-dose, a primary vaccination course of two-doses greatly improved the level and duration of immunity. We concluded that the FMD vaccination programme in Anatolian Turkey did not produce the high levels of immunity required. Higher potency vaccines are now used throughout Turkey, with a two-dose primary course in certain areas. Monitoring post-vaccination serology is an important component of evaluation for FMD vaccination programmes. However, consideration must be given to which antigens are present in the test, the vaccine and the field virus. Differences between these antigens affect the

  2. The Effect of Massage on Acute Postoperative Pain in Critically and Acutely Ill Adults Post-thoracic Surgery: Systematic Review and Meta-analysis of Randomized Controlled Trials.

    PubMed

    Boitor, Madalina; Gélinas, Céline; Richard-Lalonde, Melissa; Thombs, Brett D

    Critical care practice guidelines identify a lack of clear evidence on the effectiveness of massage for pain control. To assess the effect of massage on acute pain in critically and acutely ill adults post-thoracic surgery. Medline, Embase, CINAHL, PsychInfo, Web of Science, Scopus and Cochrane Library databases were searched. Eligible studies were randomized controlled trials (RCTs) evaluating the effect of massage compared to attention control/sham massage or standard care alone on acute pain intensity post-thoracic surgery. Twelve RCTs were included. Of these, nine evaluated massage in addition to standard analgesia, including 2 that compared massage to attention control/sham massage in the intensive care unit (ICU), 6 that compared massage to standard analgesia alone early post-ICU discharge, and 1 that compared massage to both attention control and standard care in the ICU. Patients receiving massage with analgesia reported less pain (0-10 scale) compared to attention control/sham massage (3 RCTs; N = 462; mean difference -0.80, 95% confidence interval [CI] -1.25 to -0.35; p < 0.001; I(2) = 13%) and standard care (7 RCTs; N = 1087; mean difference -0.85, 95% CI -1.28 to -0.42; p < 0.001; I(2) = 70%). Massage, in addition to pharmacological analgesia, reduces acute post-cardiac surgery pain intensity. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Anterior cruciate ligament- specialized post-operative return-to-sports (ACL-SPORTS) training: a randomized control trial.

    PubMed

    White, Kathleen; Di Stasi, Stephanie L; Smith, Angela H; Snyder-Mackler, Lynn

    2013-03-23

    Anterior cruciate ligament reconstruction (ACLR) is standard practice for athletes that wish to return to high-level activities; however functional outcomes after ACLR are poor. Quadriceps strength weakness, abnormal movement patterns and below normal knee function is reported in the months and years after ACLR. Second ACL injuries are common with even worse outcomes than primary ACLR. Modifiable limb-to-limb asymmetries have been identified in individuals who re-injure after primary ACLR, suggesting a neuromuscular training program is needed to improve post-operative outcomes. Pre-operative perturbation training, a neuromuscular training program, has been successful at improving limb symmetry prior to surgery, though benefits are not lasting after surgery. Implementing perturbation training after surgery may be successful in addressing post-operative deficits that contribute to poor functional outcomes and second ACL injury risk. 80 athletes that have undergone a unilateral ACLR and wish to return to level 1 or 2 activities will be recruited for this study and randomized to one of two treatment groups. A standard care group will receive prevention exercises, quadriceps strengthening and agility exercises, while the perturbation group will receive the same exercise program with the addition of perturbation training. The primary outcomes measures will include gait biomechanics, clinical and functional measures, and knee joint loading. Return to sport rates, return to pre-injury level of activity rates, and second injury rates will be secondary measures. The results of this ACL-Specialized Post-Operative Return To Sports (ACL-SPORTS) Training program will help clinicians to better determine an effective post-operative treatment program that will improve modifiable impairments that influence outcomes after ACLR. Randomized Control Trial NIH 5R01AR048212-07. ClinicalTrials.gov: NCT01773317.

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

    PubMed

    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.

  5. Incidence of post-operative pain after single visit and multiple visit root canal treatment: A randomized controlled trial

    PubMed Central

    Singh, Smita; Garg, Aniket

    2012-01-01

    Aim: To compare the incidence and intensity of post-obturation pain after single or multi visit root canal treatment on single rooted teeth in a randomized controlled trial. Materials and Methods: Two hundred patients requiring root canal treatment on permanent single rooted teeth (both vital and non vital) were included. The patients were assigned randomly into two groups of 100 patients each. The teeth in Group1 (n = 100) were obturated at the first visit, whilst those in Group 2 (n = 100) were obturated in a second visit 7 days later. A modified Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 6, 12, 24 and 48 hours after obturation. Independent-sample T-tests was used for statistical analysis. Results: Twelve patients were excluded from the study as they failed to follow the scheduled revisit. Data were obtained from the remaining 188 patients. There was no statistically significant difference in the incidence and intensity of post-obturation pain experienced by two groups. Conclusions: The incidence and intensity of post-obturation pain experience following one- or two-visit root canal treatment on teeth with a single canal were not significantly different. PMID:23112477

  6. Text messaging to improve attendance at post-operative clinic visits after adult male circumcision for HIV prevention: a randomized controlled trial.

    PubMed

    Odeny, Thomas A; Bailey, Robert C; Bukusi, Elizabeth A; Simoni, Jane M; Tapia, Kenneth A; Yuhas, Krista; Holmes, King K; McClelland, R Scott

    2012-01-01

    Following male circumcision for HIV prevention, a high proportion of men fail to return for their scheduled seven-day post-operative visit. We evaluated the effect of short message service (SMS) text messages on attendance at this important visit. We enrolled 1200 participants >18 years old in a two-arm, parallel, randomized controlled trial at 12 sites in Nyanza province, Kenya. Participants received daily SMS text messages for seven days (n = 600) or usual care (n = 600). The primary outcome was attendance at the scheduled seven-day post-operative visit. The primary analysis was by intention-to-treat. Of participants receiving SMS, 387/592 (65.4%) returned, compared to 356/596 (59.7%) in the control group (relative risk [RR] = 1.09, 95% confidence interval [CI] 1.00-1.20; p = 0.04). Men who paid more than US$1.25 to travel to clinic were at higher risk for failure to return compared to those who spent ≤ US$1.25 (adjusted relative risk [aRR] 1.35, 95% CI 1.15-1.58; p<0.001). Men with secondary or higher education had a lower risk of failure to return compared to those with primary or less education (aRR 0.87, 95% CI 0.74-1.01; p = 0.07). Text messaging resulted in a modest improvement in attendance at the 7-day post-operative clinic visit following adult male circumcision. Factors associated with failure to return were mainly structural, and included transportation costs and low educational level. ClinicalTrials.govNCT01186575.

  7. Pre-Study protocol MagPEP: a multicentre randomized controlled trial of magnesium sulphate in the prevention of post-ERCP pancreatitis

    PubMed Central

    2013-01-01

    Background Acute pancreatitis is the most common complication of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP). In spite of continuing research, no pharmacologic agent capable of effectively reducing the incidence of ERCP-induced pancreatitis has found its way into clinical practise. A number of experimental studies suggest that intrapancreatic calcium concentrations play an important role in the initiation of intracellular protease activation, an initiating step in the course of acute pancreatitis. Magnesium can act as a calcium-antagonist and counteracts effects in calcium signalling. It can thereby attenuate the intracellular activation of proteolytic digestive enzymes in the pancreas and reduces the severity of experimental pancreatitis when administered either intravenously or as a food supplement. Methods We designed a randomized, double-blind, placebo-controlled phase III study to test whether the administration of intravenous magnesium sulphate before and after ERCP reduces the incidence and the severity of post-ERCP pancreatitis. A total of 502 adult patients with a medical indication for ERCP are to be randomized to receive either 4930 mg magnesium sulphate (= 20 mmol magnesium) or placebo 60 min before and 6 hours after ERCP. The incidence of clinical post-ERCP pancreatitis, hyperlipasemia, pain levels, use of analgetics and length of hospital stay will be evaluated. Conclusions If magnesium sulphate is found to be effective in preventing post-ERCP pancreatitis, this inexpensive agent with limited adverse effects could be used as a routine pharmacological prophylaxis. Trial registration Current Controlled Trials ISRCTN46556454 PMID:23320650

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

    PubMed Central

    2010-01-01

    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 Infant Simulator based programs

  9. Biological and antibacterial properties of a new silver fiber post: In vitro evaluation

    PubMed Central

    Trovati, Federico; Ceci, Matteo; Chiesa, Marco; Colombo, Marco; Pietrocola, Giampiero

    2017-01-01

    Background The incorporation of nano silver particles (AgNPs) to improve antibacterial properties of dental materials has become increasingly common. The aim of the present study was to compare the antibacterial activity and cytotoxicity effects of different fiber posts: glass fiber post, quartz fiber post, nano fiber post and silver fiber post. Material and Methods The antibacterial activity against S. mutans, S. salivarius and S. sanguis was evaluated by using the agar disc diffusion test (ADT). Four wells of 3x2 mm (one for each material) were made with a punch by removing the agar and filled with the materials to be evaluated. The size of the inhibition zone was calculated. An extract was made eluting the posts in cell culture medium using the surface area-to-volume ratio of approximately 1.25cm²/ml between the surface of the samples and the volume of medium. Cell cultures were then exposed to 100 μL of the extracts medium. After 24 h, cell viability was determined using the MTT assay. Results Silver fiber post was the only material showing a fair antibacterial effect against all the three streptococcal strains. The level of cytotoxicity of all the fiber posts tested was higher than 90% and therefore they were considered not cytotoxic. Conclusions The new silver fiber post reported a fair antibacterial activity. On the other hand all the fiber posts tested (including the post with incorporated AgNPs) proved to be biocompatible, suggesting that their application does not represent a threat to human health. Key words:Antibacterial activity, agar disc diffusion test, biocompatibility, fiber post, MTT test. PMID:28298980

  10. Evaluating the Generalisability of Trial Results: Introducing a Centre- and Trial-Level Generalisability Index.

    PubMed

    Gheorghe, Adrian; Roberts, Tracy; Hemming, Karla; Calvert, Melanie

    2015-11-01

    Few randomised controlled trials (RCTs) recruit centres representatively, which may limit the external validity of trial results. The aim of this study was to propose a proof-of-concept method of assessing the generalisability of the clinical and cost-effectiveness findings of a given RCT. We developed a generalisability index (Gix), informed by centre-level characteristics, as a measure of centre and trial representativeness. The centre-level Gix quantifies how representative a centre is in relation to its jurisdiction, e.g. a country or health authority. The trial-level Gix quantifies how representative trial recruitment is in relation to clinical practice in the jurisdiction. Taking a real-world RCT as a case study and assuming trial-wide results to represent 'true jurisdiction values', we used simulation methods to recreate 5000 RCTs and investigate the relationship between trial representativeness, reflected by the standardised trial-Gix, and the deviation of simulated trial results from the 'true values'. The simulation study provides evidence that trial results (odds ratio for the primary outcome and incremental quality-adjusted life-years) were influenced by the representativeness of the sample of recruiting centres. Simulated RCTs with the closest results to the 'true values' were those whose recruitment closely mirrored the jurisdiction-wide context. Results appeared robust to six alternative specifications of the Gix. Our findings suggest that an unrepresentative selection of centres limits the external validity of trial results. The Gix may be a valuable tool to help facilitate rational selection of trial centres and ensure the generalisability of results at the jurisdiction level.

  11. Post-deployment usability evaluation of a radiology workstation.

    PubMed

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

    2016-01-01

    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 practice. The usability evaluation consisted of semi-structured interviews and observations of twelve users using the workstation during their daily work. Usability issues and positive usability findings were documented. Each issue was given a severity rating and its root cause was determined. Results were compared to the results of a pre-deployment usability evaluation of the same workstation. Ninety-two usability issues were identified, ranging from issues that cause minor frustration or delay, to issues that cause significant delays, prevent users from completing tasks, or even pose a potential threat to patient safety. The results of the pre-deployment usability evaluation had limited generalizability to clinical practice. This study showed that radiologists encountered a large number and a wide variety of usability issues when using a commercially available radiology workstation in clinical practice. This underlines the need for effective usability engineering in radiology. Given the limitations of pre-deployment usability evaluation in radiology, which were confirmed by our finding that the results of a pre-deployment usability evaluation of this workstation had limited generalizability to clinical practice, it is vital that radiology workstation vendors devote significant resources to usability engineering efforts before deployment of their workstation, and to continue these efforts after the workstation is deployed in a hospital. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  12. 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.

    PubMed

    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=<0.001) and to be referred to an occupational therapist for protective devices (p=0.022). Participants in the intervention group of a clinical trial were more likely to receive additional post trial care and improved documentation compared with those in the control group but documentation of pressure ulcer status and care is poor. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. Evaluating Pretest Effects in Pre-Post Studies

    ERIC Educational Resources Information Center

    Kim, Eun Sook; Willson, Victor L.

    2010-01-01

    This article presents a method to evaluate pretest effects on posttest scores in the absence of an un-pretested control group using published results of pretesting effects due to Willson and Putnam. Confidence intervals around the expected theoretical gain due to pretesting are computed, and observed gains or differential gains are compared with…

  14. Light-transmitting fiber optic posts: An in vitro evaluation.

    PubMed

    Stylianou, Antigoni; Burgess, John O; Liu, Perng-Ru; Givan, Daniel A; Lawson, Nathaniel C

    2017-01-01

    The clinical challenge of adhering cement to intracanal dentin is transmitting light to the most apical parts of root canals to allow more efficient polymerization of the cement. The purpose of this in vitro study was to compare the cement-polymerizing ability, microstructure, and radiopacity of a new fiber optic post (iLumi fiber optic Post) with a clinically successful fiber post (DT Light Post). Polymerizing ability was compared using a modified depth-of-polymerization protocol. A split aluminum mold with a 12-mm cylindrical hole (diameter=4.7 mm) was filled with light-polymerized resin cement (Variolink Esthetic LC). Each fiber post (n=12) was positioned and light-polymerized on the coronal end for 60 seconds with a light-emitting diode polymerization light. Unpolymerized resin was dissolved with an organic solvent, and the weight and length of the polymerized resin cement were measured. Scanning electron microscopy was used to examine vertical and horizontal cross-sections. The radiopacity values of both the posts and 5 additional reference posts were evaluated using an aluminum step wedge. The weight and length of the polymerized resin cement were significantly greater (P<.05) with the fiber optic post, which scanning electron microscopy showed to have a higher density of parallel fibers. The iLumi post demonstrated greater radiopacity among the tested fiber posts and a titanium alloy post. The iLumi fiber optic posts have a unique structural fiber composition and excellent radiopacity and light-transmitting ability that produce more complete polymerization of the resin cement than the DT Light posts. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

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

    PubMed

    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

  16. Non-Speech Oro-Motor Exercises in Post-Stroke Dysarthria Intervention: A Randomized Feasibility Trial

    ERIC Educational Resources Information Center

    Mackenzie, C.; Muir, M.; Allen, C.; Jensen, A.

    2014-01-01

    Background: There has been little robust evaluation of the outcome of speech and language therapy (SLT) intervention for post-stroke dysarthria. Non-speech oro-motor exercises (NSOMExs) are a common component of dysarthria intervention. A feasibility study was designed and executed, with participants randomized into two groups, in one of which…

  17. Non-Speech Oro-Motor Exercises in Post-Stroke Dysarthria Intervention: A Randomized Feasibility Trial

    ERIC Educational Resources Information Center

    Mackenzie, C.; Muir, M.; Allen, C.; Jensen, A.

    2014-01-01

    Background: There has been little robust evaluation of the outcome of speech and language therapy (SLT) intervention for post-stroke dysarthria. Non-speech oro-motor exercises (NSOMExs) are a common component of dysarthria intervention. A feasibility study was designed and executed, with participants randomized into two groups, in one of which…

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

    PubMed Central

    2010-01-01

    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. PMID:20958995

  19. The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial.

    PubMed

    Lindsay, Cameron; Simpson, Julie; Ispoglou, Sissi; Sturman, Steve G; Pandyan, Anand D

    2014-01-08

    Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications. Treatment of spasticity is currently delayed until a patient develops signs of these complications. This protocol is for a phase II study that aims to identify whether using OnabotulinumtoxinA (BoNT-A) in combination with physiotherapy early post stroke when initial abnormal muscle activity is neurophysiologically identified can prevent loss of range at joints and improve functional outcomes.The trial uses a screening phase to identify which people are appropriate to be included in a double blind randomised placebo-controlled trial. All patients admitted to Sandwell and West Birmingham NHS Trust Hospitals with a diagnosis of stroke will be screened to identify functional activity in the arm. Those who have no function will be appropriate for further screening. Patients who are screened and have abnormal muscle activity identified on EMG will be given electrical stimulation to forearm extensors for 3 months and randomised to have either injections of BoNT-A or normal saline. The primary outcome measure is the action research arm test - a measure of arm function. Further measures include spasticity, stiffness, muscle strength and fatigue as well as measures of quality of life, participation and caregiver strain. ISRCTN57435427, EudraCT2010-021257-39, NCT01882556.

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

    PubMed

    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 < 0.001). Reductions in anxiety in stroke survivors who received a self-help autogenic relaxation CD appear to be maintained after one year.

  1. Estimating the impact post randomization changes in staff behavior in infection prevention trials: a mathematical modeling approach.

    PubMed

    Lofgren, Eric T

    2017-08-03

    Randomized controlled trials (RCTs) of behavior-based interventions are particularly vulnerable to post-randomization changes between study arms. We assess the impact of such a change in a large, multicenter study of universal contact precautions to prevent infection transmission in intensive care units. We construct a stochastic mathematical model of methicillin-resistant Staphylococcus aureus (MRSA) acquisition in a simulated 18-bed intensive care unit (ICU). Using parameters from a recent study of contact precautions that reported a post-randomization change in contact rates, with fewer visits observed in the treatment arm, we explore the impact of several possible interpretations of this change on MRSA acquisition rates. Scenarios where contact precautions resulted in less patient visitation resulted in a mean decrease in MRSA acquisition rate of 37%, accounting for much of the effect reported in the trial. Behavior changes that impact the contact rate have the potential to drastically alter the results of RCTs in infection control settings. Careful monitoring for these changes, and an assessment of which changes will likely have the greatest impact on the study before the study begins are both recommended.

  2. A Sense of Urgency: Evaluating the Link between Clinical Trial Development Time and the Accrual Performance of CTEP-Sponsored Studies

    PubMed Central

    Cheng, Steven K.; Dietrich, Mary S.; Finnigan, Shanda; Dilts, David M.

    2010-01-01

    Purpose Post-activation 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. Experimental Design National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, non-pediatric Phase I, I/II, II, and III studies activated between 2000–2004 were investigated for an eight-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, controlling for study phase and size of expected accruals. Results 37.9 percent (n=221) of CTEP-approved oncology trials failed to attain the minimum accrual goals, with 70.8 percent (n=14) of Phase III trials resulting in poor accrual. A total of 16474 patients (42.5% of accruals) accrued to those studies that were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months development were significantly more likely to achieve accrual goals (odds ratio, 2.15; 95% CI, 1.29–3.57, P=0.003) than trials with the median development time of 12–18 months. Trials requiring a development time of greater than 24 months were significantly less likely of achieving accrual goals (odds ratio, 0.40; 95% CI, 0.20–0.78, P=0.011) than trials with the median development time. Conclusions 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. PMID:21062929

  3. Comfort evaluation of maternity support garments in a wear trial.

    PubMed

    Ho, S S; Yu, W; Lao, T T; Chow, D H K; Chung, J W; Li, Y

    2008-09-01

    This study aims to evaluate the wear comfort of eight commercially available maternity support garments. The thermophysiological, sensory/tactile and movement comfort were assessed in a wear trial using a 19-item questionnaire. Fourteen pregnant Chinese women aged 32.3 +/- 4.2 years were recruited from a local obstetric clinic. The results show that the tested garments generally provided greater sensory comfort than thermophysiological comfort. The thermophysiological comfort was mainly influenced by the fibre contents and breathability. Significant linear relationships were found between material appearance and hand feel (r = 0.86, p < 0.001), and between non-itchiness and no red mark (r = 0.78, p < 0.001). Movement comfort was influenced by the garment type and style features. Overall, the soft, good-fit, cotton/elastane maternity brief was perceived as the best product. The findings of comfort needs in pregnant women and the effects of various garment attributes would be helpful for the development of maternity support garment design criteria that are required to satisfy critical ergonomic needs. Low back pain during pregnancy is a common and significant health problem. A maternity support garment is regarded as a convenient and safe device to stabilise the lumbar spine so as to relieve pain. However, patient compliance is likely to be affected by discomfort and inconvenience. The results of this study provide guidance for the optimal design of maternity support clothing.

  4. Evaluating cognitive effort in a randomized controlled trial.

    PubMed

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

    2016-09-01

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

  5. Does post-identification feedback affect evaluations of eyewitness testimony and identification procedures?

    PubMed

    Douglass, Amy Bradfield; Neuschatz, Jeffrey S; Imrich, Jennifer; Wilkinson, Miranda

    2010-08-01

    Two experiments were conducted to test whether post-identification feedback affects evaluations of eyewitnesses. In Experiment 1 (N = 156), evaluators viewed eyewitness testimony. They evaluated witnesses who received confirming post-identification feedback as more accurate and more confident, among other judgments, compared with witnesses who received disconfirming post-identification feedback or no feedback. This pattern persisted regardless of whether the witness's confidence statement was included in the testimony. In Experiment 2 (N = 161), witness evaluators viewed the actual identification procedure in which feedback was delivered. Instructions to disregard the feedback were manipulated. Again, witnesses who received confirming feedback were assessed more positively. This pattern occurred even when witness evaluators received instructions to disregard the feedback. These experiments are the first to confirm researchers' assumptions that feedback effects on witnesses translate to changes in judgments of those witnesses.

  6. Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials.

    PubMed

    Chen, Moon S; Lara, Primo N; Dang, Julie H T; Paterniti, Debora A; Kelly, Karen

    2014-04-01

    The National Institutes of Health (NIH) Revitalization Act of 1993 mandated the appropriate inclusion of minorities in all NIH-funded research. Twenty years after this act, the proportion of minority patients enrolled in cancer clinical trials remains persistently low. Clinical trials are vehicles for the development and evaluation of therapeutic and preventive agents under scientifically rigorous conditions. Without representation in trials, it is projected that disparities in the cancer burden for minorities will increase. For this review article, the authors counted the frequency with which minorities were the primary focus of National Cancer Institute-sponsored clinical trials, examined citations from the PubMed database focusing on the search terms "NIH Revitalization Act of 1993" and "enhancing minority accrual to cancer clinical trials," and supplemented the review with their expertise in NIH-funded research related to minority accrual in cancer clinical trials. The reporting and analyses of data based on minorities in clinical trials remain inadequate. Less than 2% of the National Cancer Institute's clinical trials focus on any racial/minority population as their primary emphasis. The current review of the literature indicated that the percentage of authors who reported their study sample by race/ethnicity ranged from 1.5% to 58%, and only 20% of the randomized controlled studies published in a high-impact oncology journal reported analyzing results by race/ethnicity. Proportionately greater population increases in minorities, accompanied by their persistent and disproportionate cancer burden, reinforce the need for their greater representation in clinical trials. Renewing the emphasis for minority participation in clinical trials is warranted. Policy changes are recommended. © 2014 American Cancer Society.

  7. In Vitro Evaluation of Ferrule Effect and Depth of Post Insertion on Fracture Resistance of Fiber Posts

    PubMed Central

    Schiavetti, R.; Sannino, G.

    2012-01-01

    Purpose. The analysis of the complex model of fiber post and ferrule is given and studied in this paper. A novel approach and a solution to the evaluation of stress of post and core system within the ferrule effect are proposed. Methods. Sixty freshly extracted premolars were selected for the study. The following experimental groups were therefore defined (n = 10): (1) 5 mm, (2) 7 mm, (3) 9 mm, (4) ferrule-5 mm, (5) ferrule-7 mm, and (6) ferrule-9 mm. Preshaping drills (C) were used to prepare the root canals at 5, 7, and 9 mm in depth. In specimens of groups 3–6 a circumferential collar of tooth structure of 2 mm in height. Fluorocore 2 core build-up material (I) was used for fiber post luting. With the same material, a buildup of 2 mm in height was created. A controlled compressive load (crosshead speed: 0.75 mm/min) was applied by means of a stainless steel stylus (Ø 1 mm) at the coronal end of the post extruding out of the root. Results. In all the tests the level of significance was set at P < 0.05 . Significantly higher fracture strengths were measured in the presence of a ferrule effect. In groups 1, 2, and 3 (ferrule group), the mean fracture values were, respectively, 163,8 N, 270,9 N, and 254,7 N. These data are higher and statistically significantly different when compared with the three groups 4, 5, and 6 (no-ferrule group), in which the values obtained were, respectively, 40,5 N, 41,7 N, and 44,9 N. Conclusion. The ferrule effect in the endodontically treated teeth positively affects the fracture strength of the fiber post. Conversely, post depth insertion did not affect the resistance to fracture. PMID:23243464

  8. Post-Discharge Care of Pediatric Traumatic Brain Injury in Argentina: A Multi-Center Randomized Controlled Trial

    PubMed Central

    Carney, Nancy A.; Petroni, Gustavo J.; Luján, Silvia B.; Ballarini, Nicolás M.; Faguaga, Gabriela A.; du Coudray, Hugo E. M.; Huddleston, Amy E.; Baggio, Gloria M.; Becerra, Juan M.; Busso, Leonardo O.; Dikmen, Sureyya S.; Falcone, Roberto; García, Mirta E.; Carrillo, Osvaldo R. González; Medici, Paula L.; Quaglino, Marta B.; Randisi, Carina A.; Sáenz, Silvia S.; Temkin, Nancy R.; Vanella, Elida E.

    2016-01-01

    Objective To develop, in partnership with families of children with traumatic brain injury (TBI), a post-discharge intervention that is effective, simple and sustainable. Design Randomized Controlled Trial Setting Seven Level 1 Pediatric Trauma Centers in Argentina. Patients Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild TBI, and were discharged alive. Interventions Patients were randomly assigned to either the Intervention or Standard Care group. A specially trained Community Resource Coordinator (CRC) was assigned to each family in the Intervention group. We hypothesized that children with severe, moderate, and complicated mild TBI who received the intervention would have significantly better functional outcomes at 6-months post-discharge than those who received standard care. We further hypothesized there would be a direct correlation between patient outcome and measures of family function. Measurements and Main Results The primary outcome measure was a composite measured at 6-months post-injury. There were 308 patients included in the study; 61% male. Forty-four percent sustained a complicated mild TBI, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and scores on the Family Impact Module of the PedsQL (ρ= 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6-months post-injury. Conclusions While no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with TBI spanning hospital transport through hospital care and

  9. Economic evaluation and randomised controlled trial of extracorporeal membrane oxygenation: UK collaborative trial

    PubMed Central

    Roberts, Tracy E

    1998-01-01

    Objective: To compare the resource implications and short term outcomes of extracorporeal membrane oxygenation and conventional management for term babies with severe respiratory failure. Design: Cost effectiveness evaluation alongside a randomised controlled trial. Setting: 55 approved recruiting hospitals in the United Kingdom. These hospitals provided conventional management, but infants randomised to extracorporeal membrane oxygenation were transferred to one of five specialist centres. Subjects: 185 mature newborn infants (gestational age at birth >35 weeks, birth weight >2 kg) with severe respiratory failure (oxygenation index >40) recruited between 1993 and 1995. The commonest diagnoses were persistent pulmonary hypertension due to meconium aspiration, congenital diaphragmatic hernia, isolated persistent fetal circulation, sepsis, and idiopathic respiratory distress syndrome. Main outcome measure: Cost effectiveness based on survival at 1 year of age without severe disability. Results: 63 (68%) of the 93 infants randomised to extracorporeal membrane oxygenation survived to 1 year compared with 38 (41%) of the 92 infants who received conventional management. Of those that survived, one infant in each arm was lost to follow up and the proportion with disability at 1 year was similar in the two arms of the trial. One child in each arm had severe disability. The estimated additional cost of extracorporeal membrane oxygenation per additional surviving infant without severe disability was £51 222 and the cost per surviving infant with no disability was £75 327. Conclusions: Extracorporeal membrane oxygenation for term neonates with severe respiratory failure would increase overall survival without disability. Although the policy will increase costs of neonatal health care, it is likely to be as cost effective as other life extending technologies. Key messagesExtracorporeal membrane oxygenation increases survival for term neonates in respiratory failure

  10. Post-trial access to study medication: a Brazilian e-survey with major stakeholders in clinical research.

    PubMed

    Dainesi, Sonia M; Goldbaum, Moises

    2012-12-01

    To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. The response rate was 21%, 20% and 45% in EC, investigators and sponsors' groups, respectively. 54 patients answered the questionnaire through their doctors. The least informative item in the consent form was how to obtain the study medication after trial. If a benefit were demonstrated in the study, 60% of research participants and 35% of EC answered that all patients should continue receiving study medication after trial; 43% of investigators believed the medication should be given to participants, and 40% to subjects who participated and benefited from treatment. For 50% of the sponsors, study medication should be assured to participants who had benefited from treatment. The majority of responders answered that medication should be provided free by sponsors; investigators and sponsors believed the medication should be kept until available in the public health sector; EC members said that the patient should keep the benefit; patients answered that benefits should be assured for life. Due to the study limitations, the results cannot be generalised; however, the data can contribute to discussion of this complex topic through analysing the views of stakeholders in clinical research in Brazil.

  11. Post STS-135 Evaluation of Main Flame Deflector Witness Materials

    NASA Technical Reports Server (NTRS)

    Long, Victoria

    2011-01-01

    NASA and USA design engineers submitted witness materials from the solid rocket booster (SRB) main flame deflector for evaluation after the launch of STS-135. The following items were submitted for analysis: HY-80 steel witnes rods, 304 sta inles steel caps, and tungsten pistons. All of the items were photographed in order to document their condition after the launch of STS-135. The submitted samples were dimensionally measured in order to determine the amount of material lost during launch. Microstructural changes were observed in the HY-80 witness rod metallographic samples due to the heat of the launch.

  12. Post STS-134 Evaluation of Main Flame Deflector Witness Materials

    NASA Technical Reports Server (NTRS)

    Long, Victoria

    2011-01-01

    NASA and USA design engineers submitted witness materials from the solid rocket booster (SRB) main flame deflector for evaluation after the launch of STS-134. The following items were submitted for analysis: 1018 steel witness rods 304 stainless steel caps, tungsten pistons, and A-286 piston sleeves. All of the items were photographed in order to document their condition after the launch of STS-134. All of the items were dimensionally measured in order to determine the amount of material lost during launch. Microstructural changes were observed in the 1018 witness rod metallographic samples due to the heat of the launch

  13. In vitro evaluation of the fracture strength of all-ceramic core materials on zirconium posts.

    PubMed

    Ozcan, Nihal; Sahin, Erdal

    2013-10-01

    For most endodontically treated teeth, tooth-colored post-core systems are preferable for esthetic reasons. Therefore, improvements in material strength must also consider tooth colored post-core complexes. The objective of this study was to evaluate the difference in tooth colored post-core complex strengths. A total of 33 human maxillary central incisor teeth were used for this study, with three groups of 11 teeth. Three different methods were used to fabricate all-ceramic post-core restorations: zirconia blanks, Cerec 3D-milled to one-piece post-core restorations (Test Group 1); feldspathic cores (from feldspathic prefabricated CAD/CAM blocks) adhesively luted to CosmoPost zirconia posts (Test Group 2); and IPS Empress cores directly pressed to CosmoPost zirconia posts (Test Group 3). All-ceramic crowns from feldspathic ceramic were constructed using a CAD/CAM system (Cerec 3D) for all specimens. The post-core complexes were tested to failure with the load applied at 45° angled relative to the tooth long axis. The load at fracture was recorded. The maximum fracture strength of the milled zirconia cores (Test Group 1) was 577 N; corresponding values for the milled feldspathic cores (Test Group 2) and the pressed cores (Test Group 3) were 586 and 585 N, respectively. Differences were not statistically significant at P < 0.05 (P = 0.669). All-ceramic cores adhesively luted on zirconia posts and one-piece all-ceramic zirconium post-core structures offer a viable alternative to conventional pressing.

  14. Effect of moderate alcohol consumption on fetuin-A levels in men and women: post-hoc analyses of three open-label randomized crossover trials

    PubMed Central

    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 consumption decreases circulating levels of fetuin-A. Methods We analyzed data of three separate open-label, randomized, crossover trials: 1) 36 postmenopausal women consuming 250 ml white wine (25 g alcohol) or white grape juice daily for 6 weeks, 2) 24 premenopausal women consuming 660 ml beer (26 g alcohol) or alcohol-free beer daily for 3 weeks, and 3) 24 young men consuming 100 ml vodka (30 g alcohol) orange juice or only orange juice daily for 4 weeks. After each treatment period fasting blood samples were collected. Results Circulating fetuin-A concentrations decreased in men after vodka consumption (Mean ± SEM: 441 ± 11 to 426 ± 11 μg/ml, p = 0.02), but not in women after wine (448 ± 17 to 437 ± 17 μg/ml, p = 0.16) or beer consumption (498 ± 15 to 492 ± 15 μg/ml, p = 0.48) compared to levels after each corresponding alcohol-free treatment. Post-hoc power analyses indicated that the statistical power to detect a similar effect as observed in men was 30% among the postmenopausal women and 31% among the premenopausal women. Conclusions In these randomized crossover trials, moderate alcohol consumption decreased fetuin-A in men but not in women. This sex-specific effect may be explained by the relatively short intervention periods or the low statistical power in the trials among women. Trials registration ClinicalTrials.gov ID no’s: NCT00285909, NCT00524550, NCT00918918. PMID:24548643

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

    PubMed

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

    2017-07-24

    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 (pinteraction=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.

  16. Cytochrome c in patients undergoing coronary artery bypass grafting: A post hoc analysis of a randomized trial.

    PubMed

    Andersen, Lars W; Liu, Xiaowen; Montissol, Sophia; Holmberg, Mathias J; Fabian-Jessing, Bjørn K; Donnino, Michael W

    2017-08-04

    To establish whether plasma cytochrome c is detectable in patients undergoing cardiac surgery, whether cytochrome c levels are associated with lactate/inflammatory markers/cellular oxygen consumption, and whether cytochrome c levels are associated with clinical outcomes. This was an observational sub-study of a randomized trial comparing thiamine to placebo in patients undergoing coronary artery bypass grafting. Patients had blood drawn before, after, and again 6h after surgery. Cytochrome c, inflammatory markers, and cellular oxygen consumption were measured. 64 patients were included. Cytochrome c was detectable in 63 (98%) patients at baseline with a median cytochrome c level of 0.18ng/mL (quartiles: 0.13, 0.55). There was no difference from baseline level to post-surgical level (0.19ng/mL [0.09, 0.51], p=0.36) or between post-surgical level and 6-hour post-surgical level (0.17ng/mL [0.10, 0.57], p=0.61). There was no difference between the thiamine and placebo groups' change in cytochrome c levels from baseline to after surgery (p=0.22). Cytochrome c levels were not associated with lactate, inflammatory markers, cellular oxygen consumption, or clinical outcomes. Cytochrome c levels did not increase after cardiac surgery and was not associated with the degree of inflammation or clinical outcomes. Copyright © 2017. Published by Elsevier Inc.

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

    PubMed Central

    Kashefinejad, Mohamad; Harandi, Azade; Bijani, Ali

    2016-01-01

    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). Conclusions: The use of Mtwo (NiTi) rotary instruments in root canal preparation contributed to lower incidence of postoperative pain than hand K-files. PMID:27536323

  18. Evaluation of Pancreatic Cancer Clinical Trials and Benchmarks for Clinically Meaningful Future Trials: A Systematic Review.

    PubMed

    Rahib, Lola; Fleshman, Julie M; Matrisian, Lynn M; Berlin, Jordan D

    2016-09-01

    Progress in the treatment of pancreatic adenocarcinoma has been minimal; it remains the only major cancer type with a 5-year survival rate of less than 10%. To explore why a large proportion of advanced pancreatic cancer clinical trials executed over the past 25 years have had negative results and to identify benchmarks that could have predicted success. Phase 3 studies of patients with advanced pancreatic cancer were identified by searching clinicaltrials.gov and the scientific literature. Thirty-two phase 3 studies in 13 675 chemotherapy-naive patients resulted in 3 agents or combinations being considered clinically meaningful. Nineteen agents or combinations (70%) were tested in phase 2 trials preceding the phase 3 trial. In cases with paired phase 2 and 3 results, meeting the primary end point of the phase 2 trial predicted the outcome of the phase 3 trial 76% of the time but proceeded despite phase 2 negative results in 10 cases. We applied criteria for a clinically meaningful result identified by the American Society of Clinical Oncology (ASCO) Cancer Research Committee to these historical cases. Overall, progression-free and 1-year survival of experimental arms was compared with time period-controlled median values of control arms to normalize for the observed increase in response to gemcitabine over time. Applying the benchmark of a 50% improvement in overall survival as the primary end point to phase 2 data, or secondary end points of a 90% increase in 1-year survival or an 80% to 100% increase in progression-free survival, showed the greatest ability to predict a clinically meaningful phase 3 trial. Had these criteria been applied to these trials over the past 25 years, more than 11 571 patients enrolled in phase 3 trials that did not meet the primary end point could theoretically have been diverted to earlier-stage trials in an attempt to more rapidly advance the field.

  19. Post STS-133 Evaluation of Main Flame Deflector Witness Materials

    NASA Technical Reports Server (NTRS)

    Long, Victoria

    2011-01-01

    NASA and USA Structures engineers submitted main flame deflector witness materials for evaluation after the launch of STS-133. The following items were submitted for analysis: HY-80 steel witness rods, 304 stainless steel caps, tungsten pistons, 17-4 precipitation hardened (PH) stainless steel and A-286 piston sleeves, Medtherm Corporation calorimeters, and Nanmac Corporation thermocouples. All of the items were photographed in order to document their condition after the launch of STS-133, and before they were reinstalled at the launch pad for future launches. The HY -80 witness rods, 304 stainless steel caps, and the piston sleeves were dimensionally measured in order to determine the amount of material lost during launch. Microstructural changes were observed in the HY-80 witness rod and 304 stainless steel cap metallographic samples due to the heat of the launch.

  20. Efficacy of a universal smoking cessation intervention initiated in inpatient psychiatry and continued post-discharge: A randomised controlled trial.

    PubMed

    Metse, Alexandra P; Wiggers, John; Wye, Paula; Wolfenden, Luke; Freund, Megan; Clancy, Richard; Stockings, Emily; Terry, Margarett; Allan, John; Colyvas, Kim; Prochaska, Judith J; Bowman, Jenny A

    2017-04-01

    Interventions are required to redress the disproportionate tobacco-related health burden experienced by persons with a mental illness. This study aimed to assess the efficacy of a universal smoking cessation intervention initiated within an acute psychiatric inpatient setting and continued post-discharge in reducing smoking prevalence and increasing quitting behaviours. A randomised controlled trial was undertaken across four psychiatric inpatient facilities in Australia. Participants ( N = 754) were randomised to receive either usual care ( n = 375) or an intervention comprising a brief motivational interview and self-help material while in hospital, followed by a 4-month pharmacological and psychosocial intervention ( n = 379) upon discharge. Primary outcomes assessed at 6 and 12 months post-discharge were 7-day point prevalence and 1-month prolonged smoking abstinence. A number of secondary smoking-related outcomes were also assessed. Subgroup analyses were conducted based on psychiatric diagnosis, baseline readiness to quit and nicotine dependence. Seven-day point prevalence abstinence was higher for intervention participants (15.8%) than controls (9.3%) at 6 months post-discharge (odds ratio = 1.07, p = 0.04), but not at 12 months (13.4% and 10.0%, respectively; odds ratio = 1.03, p = 0.25). Significant intervention effects were not found on measures of prolonged abstinence at either 6 or 12 months post-discharge. Differential intervention effects for the primary outcomes were not detected for any subgroups. At both 6 and 12 months post-discharge, intervention group participants were significantly more likely to smoke fewer cigarettes per day, have reduced cigarette consumption by ⩾50% and to have made at least one quit attempt, relative to controls. Universal smoking cessation treatment initiated in inpatient psychiatry and continued post-discharge was efficacious in increasing 7-day point prevalence smoking cessation

  1. A Randomised Controlled Trial of Treatment for Post-Stroke Homonymous Hemianopia: Screening and Recruitment

    PubMed Central

    Rowe, Fiona J.; Conroy, Elizabeth J.; Barton, P. Graham; Bedson, Emma; Cwiklinski, Emma; Dodridge, Caroline; Drummond, Avril; Garcia-Finana, Marta; Howard, Claire; Johnson, Stevie; MacIntosh, Claire; Noonan, Carmel P.; Pollock, Alex; Rockliffe, Janet; Sackley, Catherine M.; Shipman, Tracey

    2016-01-01

    ABSTRACT The authors report the screening process and recruitment figures for the VISION (Visual Impairment in Stroke; Intervention Or Not) trial. This is a prospective, randomised, single-blinded, three-arm controlled trial in 14 UK acute hospital stroke units. Stroke teams identified stroke survivors suspected as having homonymous hemianopia. Interventions included Fresnel prisms versus visual search training versus standard care (information only). Primary outcome was change in visual field assessment from baseline to 26 weeks. Secondary measures included change in quality-of-life questionnaires. Recruitment opened in May 2011. A total of 1171 patients were screened by the local principal investigators. Of 1171 patients, 178 (15.2%) were eligible for recruitment: 87 patients (7.4%) provided consent and were recruited; 91 patients (7.8%) did not provide consent, and 993 of 1171 patients (84.8%) failed to meet the eligibility criteria. Almost half were excluded due to complete/partial recovery of hemianopia (43.6%; n = 511). The most common ineligibility reason was recovery of hemianopia. When designing future trials in this area, changes in eligibility criteria/outcome selection to allow more patients to be recruited should be considered, e.g., less stringent levels of visual acuity/refractive error. Alternative outcomes measurable in the home environment, rather than requiring hospital attendance for follow-up, could facilitate increased recruitment. PMID:27928375

  2. Single trial time-frequency domain analysis of error processing in post-traumatic stress disorder.

    PubMed

    Clemans, Zachary A; El-Baz, Ayman S; Hollifield, Michael; Sokhadze, Estate M

    2012-09-13

    Error processing studies in psychology and psychiatry are relatively common. Event-related potentials (ERPs) are often used as measures of error processing, two such response-locked ERPs being the error-related negativity (ERN) and the error-related positivity (Pe). The ERN and Pe occur following committed error in reaction time tasks as low frequency (4-8 Hz) electroencephalographic (EEG) oscillations registered at the midline fronto-central sites. We created an alternative method for analyzing error processing using time-frequency analysis in the form of a wavelet transform. A study was conducted in which subjects with PTSD and healthy control completed a forced-choice task. Single trial EEG data from errors in the task were processed using a continuous wavelet transform. Coefficients from the transform that corresponded to the theta range were averaged to isolate a theta waveform in the time-frequency domain. Measures called the time-frequency ERN and Pe were obtained from these waveforms for five different channels and then averaged to obtain a single time-frequency ERN and Pe for each error trial. A comparison of the amplitude and latency for the time-frequency ERN and Pe between the PTSD and control group was performed. A significant group effect was found on the amplitude of both measures. These results indicate that the developed single trial time-frequency error analysis method is suitable for examining error processing in PTSD and possibly other psychiatric disorders.

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

    PubMed

    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.

  4. A non-randomised trial of an art therapy intervention for patients with haematological malignancies to support post-traumatic growth.

    PubMed

    Singer, Susanne; Götze, Heide; Buttstädt, Marianne; Ziegler, Corinna; Richter, Robert; Brown, Anna; Niederwieser, Dietger; Dorst, Jana; Jäkel, Nadja; Geue, Kristina

    2013-07-01

    The aim of this study was to determine the effect of art therapy on post-traumatic growth in patients with haematological malignancies in a non-randomised trial (n = 36, intervention group; n = 129, control group). Art therapy was administered over a period of 22 weeks in small groups. Post-traumatic growth was measured with the Stress-Related Growth Scale. After controlling for the effect of potential confounders, no difference in post-traumatic growth was observed between the intervention and control groups after 22 weeks. There was no evidence for an effect of weekly group sessions with art therapy on post-traumatic growth in patients with haematological malignancies.

  5. Supporting the Consistent Implementation of Self-Evaluation in Irish Post-Primary Schools

    ERIC Educational Resources Information Center

    O'Brien, Shivaun; McNamara, Gerry; O'Hara, Joe

    2015-01-01

    This paper explores approaches to support the consistent implementation of school self-evaluation. The first part of the paper outlines the changing nature of self-evaluation in Irish post-primary schools and how a new approach introduced by the Department of Education and Skills in 2012 demonstrates real intentionality in terms of implementation.…

  6. Supporting the Consistent Implementation of Self-Evaluation in Irish Post-Primary Schools

    ERIC Educational Resources Information Center

    O'Brien, Shivaun; McNamara, Gerry; O'Hara, Joe

    2015-01-01

    This paper explores approaches to support the consistent implementation of school self-evaluation. The first part of the paper outlines the changing nature of self-evaluation in Irish post-primary schools and how a new approach introduced by the Department of Education and Skills in 2012 demonstrates real intentionality in terms of implementation.…

  7. Student Pre- and Post-Evaluation of an Off-Campus Clinical Clerkship

    ERIC Educational Resources Information Center

    Campbell, R. Keith

    1975-01-01

    Describes the development and use of standardized forms found to be effective for evaluating clinical clerkship experiences of pharmacy students. Copies of the Preliminary Questionnaire and the Post-Evaluation Form are included along with the goals of the Washington State University College of Pharmacy Clinical Pharmacy Program. (JT)

  8. Number needed to harm in the post-marketing safety evaluation: results for rosiglitazone and pioglitazone.

    PubMed

    Mendes, Diogo; Alves, Carlos; Batel-Marques, Francisco

    2015-12-01

    Our aim is to investigate the usefulness of metric indices in post-marketing safety evaluations by estimating number needed to harm (NNH) values for cardiovascular (CV) adverse outcomes for rosiglitazone and pioglitazone. Reports from regulatory authorities (RAs) were consulted, and Medline searches were performed to identify studies assessing CV risks [all-cause death, CV death, myocardial infarction (MI), stroke, or congestive heart failure (CHF)] for thiazolidinediones. Meta-analyses were performed to pool evidence from randomized controlled trials (RCTs) and observational studies (OS). NNHs [with 95% confidence intervals (CI)] per year were estimated for CV adverse events. Reports from RAs included two meta-analyses of short-term RCTs, two long-term RCTs (RECORD and PROACTIVE), and a systematic review of OS (n = 29). The Medline search identified six additional OS. Statistically significant NNH values were obtained for the following: (i) rosiglitazone versus control on MI and CHF in the meta-analysis of RCTs (NNH = 16; 95%CI = 10-255; and NNH = 7; 95%CI = 5-16, respectively) and meta-analysis of OS (NNH = 12; 95%CI = 9-20; and NNH = 5; 95%CI = 32-131, respectively) and on CHF in the RECORD (NNH = 6; 95%CI = 4-14); (ii) pioglitazone versus control on CHF (NNH = 11; 95%CI = 6, 403) in the meta-analysis of RCTs and PROACTIVE (NNH = 12; 95%CI = 8-43); and (iii) rosiglitazone versus pioglitazone on MI (NNH = 69; 95%CI = 32-379), stroke (NNH = 36; 95%CI = 20-225), CHF (NNH = 33; 95%CI = 19-47), and all-cause death (NNH = 63; 95%CI = 49-100) in the meta-analysis of OS. The NNH values suggested an increased CV risk with rosiglitazone versus pioglitazone across several sources of information. The inclusion of objective metrics in post-marketing drug's benefit-risk assessments could be of increased value and help RAs to make consistent decisions on drug safety. Copyright © 2015

  9. Void and gap evaluation using microcomputed tomography of different fiber post cementation techniques.

    PubMed

    Caceres, Eduardo A; Sampaio, Camila S; Atria, Pablo J; Moura, Helora; Giannini, Marcelo; Coelho, Paulo G; Hirata, Ronaldo

    2017-04-28

    Few studies have investigated the voids and gaps produced during the cementation of fiber posts using different techniques. The purpose of this study was to evaluate and quantify void and gap area formations of different fiber post cementation techniques using microcomputed tomography (μCT). Standardized endodontically treated acrylic resin roots (N=24) were divided into 4 groups (n=6) according to different fiber posts cemented with the resin cement (FB); fiber posts relined with composite resin followed by cementation (FBR); fiber posts cemented using an ultrasonic device (FBU); and fiber posts relined with composite resin and cemented using an ultrasonic device (FBRU). Each specimen was scanned twice using micro-computed tomography (μCT; empty root, followed by after fiber post cementation). Digital imaging and communications in medicine (DICOM) files were transferred into 3-dimensional (3D) reconstruction software for analysis. Void volume in the cementation system and gap area formation were evaluated; quantitative and qualitative analyses were performed. The data were analyzed using 2-way ANOVA and the Tukey honest significant difference post hoc test (α=.05). FBR showed a lower percentage of voids than obtained for FB (P<.05). Groups FB, FBU, and FBRU did not show significant difference in void formation (P>.05). No significant differences were found in gap area formations among the experimental groups (P>.05). The use of a composite resin to reline the fiber post significantly decreased the void formation in the cementation procedure when no ultrasonic device was used. The use of an ultrasonic device did not decrease the percentage of void or gap formation for any technique evaluated. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  10. Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial.

    PubMed

    Chlebowski, Rowan T; Schwartz, Ann G; Wakelee, Heather; Anderson, Garnet L; Stefanick, Marcia L; Manson, JoAnn E; Rodabough, Rebecca J; Chien, Jason W; Wactawski-Wende, Jean; Gass, Margery; Kotchen, Jane Morley; Johnson, Karen C; O'Sullivan, Mary Jo; Ockene, Judith K; Chen, Chu; Hubbell, F Allan

    2009-10-10

    In the post-intervention period of the Women's Health Initiative (WHI) trial, women assigned to treatment with oestrogen plus progestin had a higher risk of cancer than did those assigned to placebo. Results also suggested that the combined hormone therapy might increase mortality from lung cancer. To assess whether such an association exists, we undertook a post-hoc analysis of lung cancers diagnosed in the trial over the entire follow-up period. The WHI study was a randomised, double-blind, placebo-controlled trial undertaken in 40 centres in the USA. 16 608 postmenopausal women aged 50-79 years with an intact uterus were randomly assigned by a computerised, stratified, permuted block algorithm to receive a once-daily tablet of 0.625 mg conjugated equine oestrogen plus 2.5 mg medroxyprogesterone acetate (n=8506) or matching placebo (n=8102). We assessed incidence and mortality rates for all lung cancer, small-cell lung cancer, and non-small-cell lung cancer by use of data from treatment and post-intervention follow-up periods. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00000611. After a mean of 5.6 years (SD 1.3) of treatment and 2.4 years (0.4) of additional follow-up, 109 women in the combined hormone therapy group had been diagnosed with lung cancer compared with 85 in the placebo group (incidence per year 0.16%vs 0.13%; hazard ratio [HR] 1.23, 95% CI 0.92-1.63, p=0.16). 96 women assigned to combined therapy had non-small-cell lung cancer compared with 72 assigned to placebo (0.14%vs 0.11%; HR 1.28, 0.94-1.73, p=0.12). More women died from lung cancer in the combined hormone therapy group than in the placebo group (73 vs 40 deaths; 0.11%vs 0.06%; HR 1.71, 1.16-2.52, p=0.01), mainly as a result of a higher number of deaths from non-small-cell lung cancer in the combined therapy group (62 vs 31 deaths; 0.09%vs 0.05%; HR 1.87, 1.22-2.88, p=0.004). Incidence and mortality rates of small-cell lung cancer were

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

    PubMed

    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.

  12. Plaque, gingival health and post-operative sensitivity in titanium inlays and onlays: a randomized controlled clinical trial.

    PubMed

    Walter, M H; Wolf, B H; Schmidt, A E; Boening, K W; Koch, R

    2001-03-01

    Few clinical data on the use of titanium for restorative appliances are available. The aim of this study was to clinically evaluate titanium restorations compared to gold alloy restorations with regard to plaque, gingival health and post-operative sensitivity. In 54 patients, 99 titanium restorations were placed. The control group comprised 56 patients with 96 high gold alloy restorations. The material was chosen by random. Each patient received one or two Class II restorations. Plaque Index (Silness and Löe, 0-3), Gingival Index (Löe and Silness, 0-3), and post-operative sensitivity (1-4, 1=none) were rated at 2 weeks, 3 months, 6 months, 12 months, and 18 months, post-operatively. The mean plaque scores ranged from 0.89 to 0.99 in the titanium group, and from 0.88 to 1.04 in the gold group. The mean gingival scores ranged from 0.91 to 1.07 in the titanium group, and from 0.82 to 0.99 in the gold group. The mean plaque and gingival scores of the titanium and gold group did not differ significantly at any visit (P>0.05). To evaluate post-operative sensitivity, patients with one MOD restoration each were included, resulting in 46 titanium and 44 high gold restored teeth. Mean values of the post-operative sensitivity scores in the titanium group were significantly higher than in the gold group (P<0.05). The restoration material was found to be the dominating variable with regard to post-operative sensitivity, which was not influenced by age, sex and the application of calcium hydroxide liner. It is concluded that neither higher plaque scores nor adverse effects on gingival health are to be expected in titanium restorations.

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

    PubMed

    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

  14. Evaluation of surface roughness and bond strength of quartz fiber posts after various pre-treatments.

    PubMed

    Akin, Gulsah E; Akin, Hakan; Sipahi, Cumhur; Piskin, Bulent; Kirmali, Omer

    2014-11-01

    Debonding at the post-adhesive interface is a major problem for quartz fiber posts. The objective of this study was to evaluate surface roughness and bond strength of quartz fiber posts after various surface treatments. Sixty-six quartz fiber posts were randomly divided into six experimental groups (n = 11) including group C, untreated (control); group SB, sandblasted; group SC, silica coated; group HF, hydrofluoric acid-etched; group N, Nd:YAG laser irradiated; group E, Er:YAG laser irradiated. Surface roughness of the posts was measured before and after pre-treatment. They were then bonded to resin cement and tensile bond strength was determined in a universal testing machine. Furthermore, two-way ANOVA and post hoc comparison tests (α = 0.05) were performed on all data. The highest mean force value was observed in group SB and followed by group E. Tukey's HSD test showed that there was no statistical difference between group SB and group E (p = 0.673). The highest mean roughness value was observed in group SB and a significant difference was found between group SB and all other groups (p < 0.001). This study reveals that sandblasting and Er:YAG laser irradiation provided a significant increase in bond strength between quartz fiber posts and resin cement. Sandblasting or Er:YAG laser-irradiation of the surface of the quartz fiber post before cementation is recommended for increasing retention.

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

    PubMed

    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

  16. Evaluation of multisystemic therapy pilot services in the Systemic Therapy for At Risk Teens (START) trial: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background There is an urgent need for clinically effective and cost-effective methods to manage antisocial and criminal behaviour in adolescents. Youth conduct disorder is increasingly prevalent in the UK and is associated with a range of negative outcomes. Quantitative systematic reviews carried out for the National Institute for Health and Clinical Excellence have identified multisystemic therapy, an intensive, multimodal, home-based, family intervention for youth with serious antisocial behaviour, as one of the most promising interventions for reducing antisocial or offending behaviour and improving individual and family functioning. Previous international trials of multisystemic therapy have yielded mixed outcomes, and it is questionable to what extent positive US findings can be generalised to a wider UK mental health and juvenile justice context. This paper describes the protocol for the Systemic Therapy for At Risk Teens (START) trial, a multicentre UK-wide randomised controlled trial of multisystemic therapy in antisocial adolescents at high risk of out-of-home placement. Methods/Design The trial is being conducted at 10 sites across the UK. Seven hundred participants and their families will be recruited and randomised on a 1:1 basis to multisystemic therapy or management as usual. Treatments are offered over a period of 3 to 5 months, with follow-up to 18 months post-randomisation. The primary outcome is out-of-home placement at 18 months. Secondary outcomes include offending rates, total service and criminal justice sector costs, and participant well-being and educational outcomes. Data will be gathered from police computer records, the National Pupil Database, and interview and self-report measures administered to adolescents, parents and teachers. Outcomes will be analysed on an intention-to-treat basis, using a logistic regression with random effects for the primary outcome and Cox regressions and linear mixed-effects models for secondary outcomes

  17. Automatic versus manual pressure support reduction in the weaning of post-operative patients: a randomised controlled trial

    PubMed Central

    Taniguchi, Corinne; Eid, Raquel C; Saghabi, Cilene; Souza, Rogério; Silva, Eliezer; Knobel, Elias; Paes, Ângela T; Barbas, Carmen S

    2009-01-01

    Introduction Reduction of automatic pressure support based on a target respiratory frequency or mandatory rate ventilation (MRV) is available in the Taema-Horus ventilator for the weaning process in the intensive care unit (ICU) setting. We hypothesised that MRV is as effective as manual weaning in post-operative ICU patients. Methods There were 106 patients selected in the post-operative period in a prospective, randomised, controlled protocol. When the patients arrived at the ICU after surgery, they were randomly assigned to either: traditional weaning, consisting of the manual reduction of pressure support every 30 minutes, keeping the respiratory rate/tidal volume (RR/TV) below 80 L until 5 to 7 cmH2O of pressure support ventilation (PSV); or automatic weaning, referring to MRV set with a respiratory frequency target of 15 breaths per minute (the ventilator automatically decreased the PSV level by 1 cmH2O every four respiratory cycles, if the patient's RR was less than 15 per minute). The primary endpoint of the study was the duration of the weaning process. Secondary endpoints were levels of pressure support, RR, TV (mL), RR/TV, positive end expiratory pressure levels, FiO2 and SpO2 required during the weaning process, the need for reintubation and the need for non-invasive ventilation in the 48 hours after extubation. Results In the intention to treat analysis there were no statistically significant differences between the 53 patients selected for each group regarding gender (p = 0.541), age (p = 0.585) and type of surgery (p = 0.172). Nineteen patients presented complications during the trial (4 in the PSV manual group and 15 in the MRV automatic group, p < 0.05). Nine patients in the automatic group did not adapt to the MRV mode. The mean ± sd (standard deviation) duration of the weaning process was 221 ± 192 for the manual group, and 271 ± 369 minutes for the automatic group (p = 0.375). PSV levels were significantly higher in MRV compared with that of

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

    PubMed

    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

  19. A human genotyping trial to estimate the post-feeding time from mosquito blood meals

    PubMed Central

    Hiroshige, Yuuji; Hara, Masaaki; Nagai, Atsushi; Hikitsuchi, Tomoyuki; Umeda, Mitsuo; Kawajiri, Yumi; Nakayama, Koji; Suzuki, Koichi; Takada, Aya; Ishii, Akira

    2017-01-01

    Mosquitoes occur almost worldwide, and females of some species feed on blood from humans and other animals to support ovum maturation. In warm and hot seasons, such as the summer in Japan, fed mosquitoes are often observed at crime scenes. The current study attempted to estimate the time that elapsed since feeding from the degree of human DNA digestion in mosquito blood meals and also to identify the individual human sources of the DNA using genotyping in two species of mosquito: Culex pipiens pallens and Aedes albopictus. After stereomicroscopic observation, the extracted DNA samples were quantified using a human DNA quantification and quality control kit and were genotyped for 15 short tandem repeats using a commercial multiplexing kit. It took about 3 days for the complete digestion of a blood meal, and genotyping was possible until 2 days post-feeding. The relative peak heights of the 15 STRs and DNA concentrations were useful for estimating the post-feeding time to approximately half a day between 0 and 2 days. Furthermore, the quantitative ratios derived from STR peak heights and the quality control kit (Q129/Q41, Q305/Q41, and Q305/Q129) were reasonably effective for estimating the approximate post-feeding time after 2–3 days. We suggest that this study may be very useful for estimating the time since a mosquito fed from blood meal DNA, although further refinements are necessary to estimate the times more accurately. PMID:28617865

  20. A human genotyping trial to estimate the post-feeding time from mosquito blood meals.

    PubMed

    Hiroshige, Yuuji; Hara, Masaaki; Nagai, Atsushi; Hikitsuchi, Tomoyuki; Umeda, Mitsuo; Kawajiri, Yumi; Nakayama, Koji; Suzuki, Koichi; Takada, Aya; Ishii, Akira; Yamamoto, Toshimichi

    2017-01-01

    Mosquitoes occur almost worldwide, and females of some species feed on blood from humans and other animals to support ovum maturation. In warm and hot seasons, such as the summer in Japan, fed mosquitoes are often observed at crime scenes. The current study attempted to estimate the time that elapsed since feeding from the degree of human DNA digestion in mosquito blood meals and also to identify the individual human sources of the DNA using genotyping in two species of mosquito: Culex pipiens pallens and Aedes albopictus. After stereomicroscopic observation, the extracted DNA samples were quantified using a human DNA quantification and quality control kit and were genotyped for 15 short tandem repeats using a commercial multiplexing kit. It took about 3 days for the complete digestion of a blood meal, and genotyping was possible until 2 days post-feeding. The relative peak heights of the 15 STRs and DNA concentrations were useful for estimating the post-feeding time to approximately half a day between 0 and 2 days. Furthermore, the quantitative ratios derived from STR peak heights and the quality control kit (Q129/Q41, Q305/Q41, and Q305/Q129) were reasonably effective for estimating the approximate post-feeding time after 2-3 days. We suggest that this study may be very useful for estimating the time since a mosquito fed from blood meal DNA, although further refinements are necessary to estimate the times more accurately.

  1. Post-prison Release HIV-Risk Behaviors in a Randomized Trial of Methadone Treatment for Prisoners

    PubMed Central

    Wilson, Monique E.; Kinlock, Timothy W.; Gordon, Michael S.; O’Grady, Kevin E.; Schwartz, Robert P.

    2012-01-01

    Background This secondary analysis examined the impact of methadone initiated in prison on post-release HIV risk behaviors. The parent study was a three-group randomized clinical trial in which participants received drug abuse counseling in prison and were randomly assigned to: (1) passive referral to substance abuse treatment upon release; (2) guaranteed methadone treatment admission upon release; and (3) methadone in prison and guaranteed continuation of methadone upon release. Methods Participants were 211 adult males with pre-incarceration histories of opiate dependence. The AIDS Risk Assessment was administered at baseline (in prison) and at 1-, 3-, 6-, and 12-months post-release. Data were analyzed for the entire sample (N = 211) as well as the subsamples who reported injecting drugs in the 30 days prior to incarceration (n = 131) and who reported having unprotected sex in that time frame (n = 144) using generalized linear mixed model on an intent-to-treat basis. Results There were no significant changes in sex- or drug-risk by Condition over Time. There were significant Time and Condition main effects for the total sample as well as the injector subsample for drug-risk behaviors. There were no significant Condition main effects for HIV sex–risk behaviors, but there were significant Time main effects. Conclusions Methadone initiated in prison or immediately post-release is associated with reduced HIV drug-risk compared to counseling in prison without methadone and passive referral to treatment at release. Participation in several drug- and sex-risk behaviors also showed significant declines during the post-release time periods. PMID:22882399

  2. D-Cycloserine Augmentation of Exposure Therapy for Post-Traumatic Stress Disorder: A Pilot Randomized Clinical Trial

    PubMed Central

    Difede, JoAnn; Cukor, Judith; Wyka, Katarzyna; Olden, Megan; Hoffman, Hunter; Lee, Francis S; Altemus, Margaret

    2014-01-01

    Viewing post-traumatic stress disorder (PTSD) as a disorder of emotional learning, this study used a cognitive enhancer synergistically with virtual reality exposure (VRE) therapy for the treatment of PTSD. The main objective was to determine if a novel pharmacotherapy, D-cycloserine (DCS), enhanced the efficacy of the psychotherapy. Pre-clinical studies suggest that when fear extinction occurs during DCS administration, neuroplasticity may be enhanced. VRE therapy is a particularly promising format to test the hypothesis that DCS enhances extinction learning, as sensory fear cues are standardized across patients. In a pilot randomized, double-blind, placebo-controlled trial, 100 mg of DCS or placebo was administered 90 min before each weekly VRE session, to ensure peak plasma concentrations during the sessions in 25 patients with chronic PTSD. The primary outcome measure was the Clinician Administered PTSD Scale (CAPS). Secondary outcome measures included the Beck Depression Inventory-II and the State-Trait Anger Expression Inventory-2. Assessments occurred at pre-treatment, following sessions 3, 6, 10, post-treatment, and at 6 months. The difference in CAPS between the VRE-DCS (n=13) and VRE-placebo (n=12) groups increased over time beginning at 6 weeks, with medium to large between-group effect sizes immediately post-treatment and 6 months later (d=0.68 and d=1.13, respectively). A similar pattern was observed for depression, anger expression, and sleep. PTSD remission rates were significantly greater for the VRE-DCS group (46% vs 8% at post-treatment; 69% vs 17% at 6 months). Patients in the VRE-DCS group showed earlier and greater improvement in PTSD symptoms compared with the VRE-placebo group. These results suggest a promising new treatment for PTSD. PMID:24217129

  3. Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders.

    PubMed

    Sannibale, Claudia; Teesson, Maree; Creamer, Mark; Sitharthan, Thiagarajan; Bryant, Richard A; Sutherland, Kylie; Taylor, Kirsten; Bostock-Matusko, Delphine; Visser, Alicia; Peek-O'Leary, Marie

    2013-08-01

    Aims This study aimed to test the efficacy of integrated cognitive behaviour therapy (CBT) for coexisting post traumatic stress disorder (PTSD) and alcohol use disorders (AUD). Setting Clinics across Sydney, Australia.Design Randomized controlled trial of 12 once-weekly individual sessions of either integrated CBT for PTSD and AUD(integrated therapy, IT; n = 33) or CBT for AUD plus supportive counselling (alcohol-support, AS; n = 29). Blind assessments were conducted at baseline and post-treatment and at 5 [standard deviation (SD) = 2.25] and 9.16(SD = 3.45) months post-treatment. Participants Sixty-two adults with concurrent PTSD and AUD. Measurements Outcomes included changes in alcohol consumption (time-line follow-back), PTSD severity [clinician-administered PTSD scale (CAPS)], alcohol dependence and problems, and depression and anxiety. Findings Reductions in PTSD severity were evident in both groups. IT participants who had received one or more sessions of exposure therapy exhibited a twofold greater rate of clinically significant change in CAPS severity at follow-up than AS participants [IT60%, AS 39%, odds ratio (OR): 2.31, 95% confidence interval (CI): 1.06, 5.01]. AS participants exhibited larger reductions than IT participants in alcohol consumption, dependence and problems within the context of greater treatment from other services during follow-up. Results lend support to a mutually maintaining effect between AUD and PTSD. Conclusions Individuals with severe and complex presentations of coexisting post-traumatic stress disorder(PTSD) and alcohol use disorders (AUD) can derive substantial benefit from cognitive behaviour therapy targeting AUD, with greater benefits associated with exposure for PTSD. Among individuals with dual disorders, these therapies can generate significant, well-maintained treatment effects on PTSD, AUD and psychopathology.

  4. Chronic resistance training does not affect post-exercise blood pressure in normotensive older women: a randomized controlled trial.

    PubMed

    Gerage, Aline Mendes; Ritti-Dias, Raphael Mendes; do Nascimento, Matheus Amarante; Pina, Fábio Luiz Cheche; Gonçalves, Cássio Gustavo Santana; Sardinha, Luís B; Cyrino, Edilson Serpeloni

    2015-06-01

    Resistance training has been recommended for maintenance or improvement of the functional health of older adults, but its effect on acute cardiovascular responses remains unclear. Thus, the purpose of this study was to analyze the effect of 12 weeks of resistance training on post-exercise blood pressure (BP) in normotensive older women. Twenty-eight normotensive and physically inactive women (≥ 60 years) were randomly assigned to a training group (TG) or a control group (CG). The TG underwent a resistance training program (12 weeks, 8 exercises, 2 sets, 10-15 repetitions, 3 days/week), while the CG performed stretching exercises (12 weeks, 2 sets, 20 s each, 2 days/week). At baseline and after the intervention, participants were randomly submitted to two experimental sessions: a resistance exercise session (7 exercises, 2 sets, 10-15 repetitions) and a control session. BP was obtained pre- and post-sessions (90 min), through auscultation. Post-exercise hypotension was observed for systolic, diastolic, and mean BP in the TG (-6.1, -3.4, and -4.3 mmHg, respectively; P < 0.05) and in the CG (-4.1, -0.7, and -1.8 mmHg, respectively; P < 0.05). After the intervention period, the magnitude and pattern of this phenomenon for systolic, diastolic, and mean BP were similar between groups (TG -8.8, -4.1, and -5.7 mmHg, respectively; P < 0.05 vs CG -11.1, -5.8, and -7.6 mmHg, respectively; P < 0.05). These results indicate that a single session of resistance exercise promotes reduction in post-exercise BP and 12 weeks of resistance training program do not change the occurrence or magnitude of this hypotension. (ClinicalTrial.gov: NCT02346981).

  5. Associations of Hospital and Patient Characteristics with Fluid Resuscitation Volumes in Patients with Severe Sepsis: Post Hoc Analyses of Data from a Multicentre Randomised Clinical Trial.

    PubMed

    Hjortrup, Peter Buhl; Haase, Nicolai; Wetterslev, Jørn; Perner, Anders

    2016-01-01

    Fluid resuscitation is a key intervention in patients with sepsis and circulatory impairment. The recommendations for continued fluid therapy in sepsis are vague, which may result in differences in clinical practice. We aimed to evaluate associations between hospital and patient characteristics and fluid resuscitation volumes in ICU patients with severe sepsis. We explored the 6S trial database of ICU patients with severe sepsis needing fluid resuscitation randomised to hydroxyethyl starch 130/0.42 vs. Ringer's acetate. Our primary outcome measure was fluid resuscitation volume and secondary outcome total fluid input administered from 24 hours before randomisation until the end of day 3 post-randomisation. We performed multivariate analyses with hospital and patient baseline characteristics as covariates to assess associations with fluid volumes given. We included 654 patients who were in the ICU for 3 days and had fluid volumes available. Individual trial sites administered significantly different volumes of fluid resuscitation and total fluid input after adjusting for baseline variables (P<0.001). Increased lactate, higher cardiovascular and renal SOFA subscores, lower respiratory SOFA subscore and surgery were all independently associated with increased fluid resuscitation volumes. Hospital characteristics adjusted for patient baseline values were associated with differences in fluid resuscitation volumes given in the first 3 days of severe sepsis. The data indicate variations in clinical practice not explained by patient characteristics emphasizing the need for RCTs assessing fluid resuscitation volumes fluid in patients with sepsis.

  6. Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial

    PubMed Central

    Brouwer, Marc A; Wojdyla, Daniel M; Thomas, Laine; Lopes, Renato D; Washam, Jeffrey B; Lanas, Fernando; Xavier, Denis; Husted, Steen; Wallentin, Lars; Alexander, John H; Granger, Christopher B; Verheugt, Freek W A

    2016-01-01

    Objective To determine whether the treatment effect of apixaban versus warfarin differs with increasing numbers of concomitant drugs used by patients with atrial fibrillation. Design Post hoc analysis performed in 2015 of results from ARISTOTLE (apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation)—a multicentre, double blind, double dummy trial that started in 2006 and ended in 2011. Participants 18 201 ARISTOTLE trial participants. Interventions In the ARISTOTLE trial, patients were randomised to either 5 mg apixaban twice daily (n=9120) or warfarin (target international normalised ratio range 2.0-3.0; n=9081). In the post hoc analysis, patients were divided into groups according to the number of concomitant drug treatments used at baseline (0-5, 6-8, ≥9 drugs) with a median follow-up of 1.8 years. Main outcome measures Clinical outcomes and treatment effects of apixaban versus warfarin (adjusted for age, sex, and country). Results Each patient used a median of six drugs (interquartile range 5-9); polypharmacy (≥5 drugs) was seen in 13 932 (76.5%) patients. Greater numbers of concomitant drugs were used in older patients, women, and patients in the United States. The number of comorbidities increased across groups of increasing numbers of drugs (0-5, 6-8, ≥9 drugs), as did the proportions of patients treated with drugs that interact with warfarin or apixaban. Mortality also rose significantly with the number of drug treatments (P<0.001), as did rates of stroke or systemic embolism (1.29, 1.48, and 1.57 per 100 patient years, for 0-5, 6-8, and ≥9 drugs, respectively) and major bleeding (1.91, 2.46, and 3.88 per 100 patient years, respectively). Relative risk reductions in stroke or systemic embolism for apixaban versus warfarin were consistent, regardless of the number of concomitant drugs (Pinteraction=0.82). A smaller reduction in major bleeding was seen with apixaban versus warfarin with increasing numbers

  7. Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial.

    PubMed

    Jaspers Focks, Jeroen; Brouwer, Marc A; Wojdyla, Daniel M; Thomas, Laine; Lopes, Renato D; Washam, Jeffrey B; Lanas, Fernando; Xavier, Denis; Husted, Steen; Wallentin, Lars; Alexander, John H; Granger, Christopher B; Verheugt, Freek W A

    2016-06-15

     To determine whether the treatment effect of apixaban versus warfarin differs with increasing numbers of concomitant drugs used by patients with atrial fibrillation.  Post hoc analysis performed in 2015 of results from ARISTOTLE (apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation)-a multicentre, double blind, double dummy trial that started in 2006 and ended in 2011.  18 201 ARISTOTLE trial participants.  In the ARISTOTLE trial, patients were randomised to either 5 mg apixaban twice daily (n=9120) or warfarin (target international normalised ratio range 2.0-3.0; n=9081). In the post hoc analysis, patients were divided into groups according to the number of concomitant drug treatments used at baseline (0-5, 6-8, ≥9 drugs) with a median follow-up of 1.8 years.  Clinical outcomes and treatment effects of apixaban versus warfarin (adjusted for age, sex, and country).  Each patient used a median of six drugs (interquartile range 5-9); polypharmacy (≥5 drugs) was seen in 13 932 (76.5%) patients. Greater numbers of concomitant drugs were used in older patients, women, and patients in the United States. The number of comorbidities increased across groups of increasing numbers of drugs (0-5, 6-8, ≥9 drugs), as did the proportions of patients treated with drugs that interact with warfarin or apixaban. Mortality also rose significantly with the number of drug treatments (P<0.001), as did rates of stroke or systemic embolism (1.29, 1.48, and 1.57 per 100 patient years, for 0-5, 6-8, and ≥9 drugs, respectively) and major bleeding (1.91, 2.46, and 3.88 per 100 patient years, respectively). Relative risk reductions in stroke or systemic embolism for apixaban versus warfarin were consistent, regardless of the number of concomitant drugs (Pinteraction=0.82). A smaller reduction in major bleeding was seen with apixaban versus warfarin with increasing numbers of concomitant drugs (Pinteraction=0.017). Patients with interacting

  8. A Crossover Trial Evaluating an Educational-Behavioral Joint Protection Programme for People with Rheumatoid Arthritis.

    ERIC Educational Resources Information Center

    Hammond, A.; Lincoln, N.; Sutcliffe, L.

    1999-01-01

    Joint protection, a self-management technique taught to people with rheumatoid arthritis, was used in a group education program. A crossover trial (N=35) was conducted. No significant changes in measures of pain, functional disability, grip strength, self-efficacy or helplessness occurred post-education, although this may have been due to the…

  9. A Crossover Trial Evaluating an Educational-Behavioral Joint Protection Programme for People with Rheumatoid Arthritis.

    ERIC Educational Resources Information Center

    Hammond, A.; Lincoln, N.; Sutcliffe, L.

    1999-01-01

    Joint protection, a self-management technique taught to people with rheumatoid arthritis, was used in a group education program. A crossover trial (N=35) was conducted. No significant changes in measures of pain, functional disability, grip strength, self-efficacy or helplessness occurred post-education, although this may have been due to the…

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

    PubMed

    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

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

    PubMed Central

    2011-01-01

    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, operationalized as the Short Physical

  12. Management of post-ethmoidectomy crust formation: randomized single-blind clinical trial comparing pressurized seawater versus antiseptic/mucolytic saline.

    PubMed

    Pigret, D; Jankowski, R

    1996-03-01

    This study compared the efficacy of mechanical nasal lavages with pressurized seawater versus nasal irrigations with saline plus benzododecinium (antiseptic) plus oleosorbate (mucolytic). Twenty patients agreed to participate in a randomized, single-blind clinical trial. All patients underwent endoscopic endonasal ethmoidectomy for nasal polyps. The packing was removed after 48 h and patients were asked to start the same day nasal lavages three times a day. Clinical evaluations were performed: (1) by weighing residual nasal crusts and secretions after 21 +/- 2 days; and (2) by using visual analogue scales to daily record symptom scores. Data are presented as mean +/- SEM. T-test statistics for two independent groups were applied. The mean residual crust and secretion weights were 1,756 +/- 688 mg and 1,033 +/- 422 mg in the pressurized seawater group, 932 +/- 414 mg and 1,222 +/- 435 mg in the antiseptic-mucolytic saline group. No statistical differences were found. Sample size calculations showed that 100 subjects in each group would be necessary to confirm a 700-mg reduction in residual crusts in the antiseptic/mucolytic saline group (power = 0.80; two-sided type-I error = 0.05). Daily symptom score curves were similar in both groups and allowed us to give a description of post-operative complaints. The role of antiseptic, mucolytic and mechanical lavages in preventing post-ethmoidectomy crust formation is discussed.

  13. Flourishing in people with depressive symptomatology increases with Acceptance and Commitment Therapy. Post-hoc analyses of a randomized controlled trial.

    PubMed

    Bohlmeijer, Ernst T; Lamers, Sanne M A; Fledderus, Martine

    2015-02-01

    Mental health is more than the absence of mental illness. Rather, both well-being (positive mental health) and mental illness are actually two related continua, with higher levels of well-being defined as "flourishing." This two-continua model and existing studies about the impact of flourishing on psychopathology underscore the need for interventions that enhance flourishing and well-being. Acceptance and Commitment Therapy (ACT) is a model of cognitive behavioral therapy that aims not only to reduce psychopathology but also to promote flourishing as well. This is the first study to evaluate the impact of ACT on flourishing. A post-analysis was conducted on an earlier randomized controlled trial of a sample of adults with depressive symptomatology who participated in a guided self-help ACT intervention. This post-analysis showed a 5%-28% increase of flourishing by the participants. In addition, the effects on flourishing were maintained at the three-month follow-up. When compared to participants in a control group, the flourishing of the ACT-trained participants increased from 5% to about 14% after nine weeks. In addition to levels of positive mental health at baseline, an increase of psychological flexibility during the intervention was a significant predictor of flourishing at the three-month follow-up. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

    PubMed Central

    2013-01-01

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

  15. Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial

    PubMed Central

    2013-01-01

    Background Low-level laser therapy (LLLT) has been shown to modulate the inflammatory process without adverse effects , by reducing pain and swelling and promoting the repair of damaged tissues. Because pain, swelling and muscle spasm are complications found in virtually all patients following oral surgery for the removal of impacted teeth, this model has been widely used to evaluate the effects of LLLT on the inflammatory process involving bone and, connective tissue and the muscles involved in mastication. Methods/Design After meeting the eligibility criteria, 60 patients treated at a Specialty Dental Center for the removal of impacted lower third molars will be randomly divided into five groups according to the type of laser therapy used at the end of surgery (intraoral irradiation with 660 nm laser; extraoral irradiation with 660 nm laser; intraoral irradiation with 808 nm laser; extraoral irradiation with 808 nm laser and no irradiation). To ensure that patients are blinded to the type of treatment they are receiving, the hand piece of the laser apparatus will be applied both intraorally and extraorally to all participants, but the device will be turned on only at the appropriate time, as determined by the randomization process. At 2 and 7 days after surgery, the patients will be evaluated by three blinded evaluators who will measure of swelling, mouth opening (muscle spasm evaluation) and pain (using two different pain scales). The 14-item Oral Health Impact Profile (OHIP-14) will be used to assess QOL. All data will be analyzed with respect to the normality of distribution using the Shapiro-Wilk test. Statistically significant differences between the experimental groups will be determined using analysis of variance, followed by a suitable post hoc test, when necessary. The significance level will be set at α = 0.05. Discussion The lack of standardization in studies with regard to the samples, methods and LLLT parameters complicates the

  16. The Effect of Prophylactic Antibiotics on Post Laparoscopic Cholecystectomy Infectious Complications: A Double-Blinded Clinical Trial

    PubMed Central

    Darzi, Ali Asghar; Nikmanesh, Alieh; Bagherian, Farhad

    2016-01-01

    Background Laparoscopic cholecystectomy (LC) is one of the most common surgeries in laparoscopic surgery. Although, it is believed that LC has low-risk for post-operative infectious complications, the use of a prophylactic antibiotic is still controversial in elective LC. Objective To determine the impact of prophylactic antibiotics on postoperative infection complications in elective laparoscopic cholecystectomy. Methods In this double-blind, placebo-controlled, randomized, clinical trial, patients who were candidates for elective LC, from March 2012 to 2015, in four hospitals in Babol, Iran, were studied. Patients were allocated randomly to two groups, i.e., group C: Cefazolin (n = 182) and group P: placebo (n = 247). Group C received 1 g of Cefazolin 30 minutes before anesthesia and and then, six and 12 hours after anesthesia. Group P patients received 10 ml of isotonic sodium chloride solution. Age, gender, type of gallbladder diseases (stone, polyp, or hydrops), the length of post-operative hospitalization, frequency of gallbladder rupture, the duration of surgery, and the kinds of complications associated with infections were collected for each patient in the two groups. The data were analyzed by IBM-SPSS version 20, using the t-test and the chi-squared test, and a p-value < 0.05 was considered as significant. Results There were no significant differences between the two groups in terms of gender (C versus P: 18 (9.9%) male versus 22 (9%); p = 0.74), age (C versus P: 43.75 + 13.30 years versus 40.91 + 13.05; p = 0.20), and duration of surgery (C versus P: 34.97 ± 8.25 min versus 34.11 ± 8.39; p = 0.71). There were no significant differences between the two groups in the incidences of post-operative infection (C versus P: 3 (1.7%) versus 5 (2%); p = 0.99) and rupture of the gallbladder (C versus P: 14 (7.8%) versus 17 (6.8%); p = 0.85). No other post-operative systemic infectious complications (e.g., sepsis, pneumonia, or urinary tract infection) were found

  17. In vitro evaluation of the fracture strength of all-ceramic core materials on zirconium posts

    PubMed Central

    Ozcan, Nihal; Sahin, Erdal

    2013-01-01

    Objective: For most endodontically treated teeth, tooth-colored post-core systems are preferable for esthetic reasons. Therefore, improvements in material strength must also consider tooth colored post-core complexes. The objective of this study was to evaluate the difference in tooth colored post–core complex strengths. Materials and Methods: A total of 33 human maxillary central incisor teeth were used for this study, with three groups of 11 teeth. Three different methods were used to fabricate all-ceramic post-core restorations: zirconia blanks, Cerec 3D-milled to one-piece post-core restorations (Test Group 1); feldspathic cores (from feldspathic prefabricated CAD/CAM blocks) adhesively luted to CosmoPost zirconia posts (Test Group 2); and IPS Empress cores directly pressed to CosmoPost zirconia posts (Test Group 3). All-ceramic crowns from feldspathic ceramic were constructed using a CAD/CAM system (Cerec 3D) for all specimens. The post-core complexes were tested to failure with the load applied at 45° angled relative to the tooth long axis. The load at fracture was recorded. Results: The maximum fracture strength of the milled zirconia cores (Test Group 1) was 577 N; corresponding values for the milled feldspathic cores (Test Group 2) and the pressed cores (Test Group 3) were 586 and 585 N, respectively. Differences were not statistically significant at P < 0.05 (P = 0.669). Conclusions: All-ceramic cores adhesively luted on zirconia posts and one-piece all-ceramic zirconium post–core structures offer a viable alternative to conventional pressing. PMID:24932121

  18. Predictors of post-treatment relapse to smoking in successful quitters: Pooled data from two phase III varenicline trials

    PubMed Central

    Heffner, Jaimee L.; Lee, Theodore C.; Arteaga, Carmen; Anthenelli, Robert M.

    2010-01-01

    Background Identifying predictors of smoking relapse helps to elucidate the challenges of long-term smoking cessation and provides direction for improved treatment development. Methods In this post hoc data analysis, we examined predictors of relapse from end-of-treatment (week 13) through 1-year follow-up (week 52) for treatment-responding participants who achieved the primary efficacy endpoint of 4-week continuous abstinence (weeks 9–12), during two phase III varenicline trials. Results Of 626 smokers classified as treatment responders for all treatment groups across both trials, 301 (48%) relapsed during follow-up (weeks 13–52). The odds of relapsing were almost 5 times greater (odds ratio [OR]=4.92, 95% confidence interval [CI]: 2.77–8.97; p<.001) for treatment responders who did not initiate continuous abstinence until the final 4 weeks of the treatment period compared with those who initiated continuous abstinence by their quit date. Participants who reported >30 days of abstinence during the year prior to study entry were significantly more likely to relapse than those who reported 0 days of abstinence (OR=2.38, 95% CI: 1.17–5.04; p=.013). Conclusion Results of these analyses suggest that the ability to quit smoking on the initial quit date and maintain abstinence throughout the treatment period is a good prognostic indicator for long-term abstinence. The relationship between post-treatment relapse and longer pretreatment periods of abstinence is counterintuitive, yet not without precedence in the literature. PMID:20071105

  19. Weight Lifting and Physical Function Among Survivors of Breast Cancer: A Post Hoc Analysis of a Randomized Controlled Trial

    PubMed Central

    Brown, Justin C.; Schmitz, Kathryn H.

    2015-01-01

    Purpose Survivors of breast cancer may experience deterioration of physical function. This is important because poor physical function may be associated with premature mortality, injurious falls, bone fracture, and disability. We conducted a post hoc analysis to explore the potential efficacy of slowly progressive weight lifting to reduce the incidence of physical function deterioration among survivors of breast cancer. Methods Between October 2005 and August 2008, we conducted a single-blind, 12-month, randomized controlled trial of twice-per-week slowly progressive weight lifting or standard care among 295 survivors of nonmetastatic breast cancer. In this post hoc analysis of data from the Physical Activity and Lymphedema Trial, we examined incident deterioration of physical function after 12 months, defined as a ≥ 10-point decrease in the physical function subscale of the Medical Outcomes Short-Form 36-item questionnaire. Results The proportion of participants who experienced incident physical function deterioration after 12 months was 16.3% (24/147) in the control group and 8.1% (12/148) in the weight lifting group (relative risk, 0.49; 95% CI, 0.25 to 0.96; P = .04). No serious or unexpected adverse events occurred that were related to weight lifting. Conclusion Slowly progressive weight lifting compared with standard care reduced the incidence of physical function deterioration among survivors of breast cancer. These data are hypothesis generating. Future studies should directly compare the efficacy of weight lifting with other modalities of exercise, such as brisk walking, to appropriately inform the development of a confirmatory study designed to preserve physical function among survivors of breast cancer. PMID:25964257

  20. Lung recruitment and positive airway pressure before extubation does not improve oxygenation in the post-anaesthesia care unit: a randomized clinical trial.

    PubMed

    Lumb, A B; Greenhill, S J; Simpson, M P; Stewart, J

    2010-05-01

    Atelectasis is known to develop during anaesthesia and after operation atelectasis leads to impaired oxygenation. Lung recruitment manoeuvres, positive end-expiratory pressure (PEEP), and continuous positive airway pressure (CPAP) have been proposed for reduction of atelectasis but their benefits have not been shown to persist after operation. We proposed that a combination of these techniques before extubation would improve oxygenation after operation. Adult patients undergoing elective surgery requiring tracheal intubation and an arterial catheter were randomized to receive either: a lung recruitment manoeuvre of 40 cm H(2)O for 15 s, 30 min before the end of anaesthesia, followed by 10 cm H(2)O of PEEP and then 10 cm H(2)O of CPAP from return of spontaneous breathing until extubation; or no lung recruitment manoeuvre, evaluate more invasive clinical strategies such as post-extubation CPAP. Trial registered at URL http://www.controlled-trials.com Identification number: ISRCTN32464251 (http://www.controlled-trials.com/ISRCTN32464251).

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

    PubMed

    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 < 0.001) poor monitoring/inconsistent discipline (p < .001), adolescent delinquency/aggressive behaviour (both p < .001), and improvements in positive/involved parenting (p

  2. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Drugs Intended... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and...

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

    ERIC Educational Resources Information Center

    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.

  4. New Relationship with Schools: Evaluation of Trial Local Authorities and Schools. RR689

    ERIC Educational Resources Information Center

    Halsey, Karen; Judkins, Michelle; Atkinson, Mary; Rudd, Peter

    2005-01-01

    This summary outlines the key findings from a national evaluation of the first-year trials of the New Relationship with Schools (NRwS) carried out by a team at the National Foundation for Educational Research (NFER). The trials took place in the period September 2004 to July 2005 and involved 93 schools in eight local educational authorities…

  5. Assessment of the Reliability and Validity of the Discrete-Trials Teaching Evaluation Form

    ERIC Educational Resources Information Center

    Babel, Danielle A.; Martin, Garry L.; Fazzio, Daniela; Arnal, Lindsay; Thomson, Kendra

    2008-01-01

    Discrete-trials teaching (DTT) is a frequently used method for implementing Applied Behavior Analysis treatment with children with autism. Fazzio, Arnal, and Martin (2007) developed a 21-component checklist, the Discrete-Trials Teaching Evaluation Form (DTTEF), for assessing instructors conducting DTT. In Phase 1 of this research, three experts on…

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

    ERIC Educational Resources Information Center

    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. Evaluation of the utility of a discrete-trial functional analysis in early intervention classrooms.

    PubMed

    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.

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

    EPA Science Inventory

    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...

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

    EPA Science Inventory

    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...

  10. Buprenorphine and Methadone Maintenance in Jail and Post-Release: A Randomized Clinical Trial

    PubMed Central

    Magura, Stephen; Lee, Joshua D.; Hershberger, Jason; Joseph, Herman; Marsch, Lisa; Shropshire, Carol; Rosenblum, Andrew

    2009-01-01

    Buprenorphine has rarely been administered as an opioid agonist maintenance therapy in a correctional setting. This study introduced buprenorphine maintenance in a large urban jail, Rikers Island in New York City. Heroin-dependent men not enrolled in community methadone treatment and sentenced to 10-90 days in jail (N=116) were voluntarily randomly assigned either to buprenorphine or methadone maintenance, the latter being the standard of care for eligible inmates at Rikers. Buprenorphine and methadone maintenance completion rates in jail were equally high, but the buprenorphine group reported for their designated post-release treatment in the community significantly more often than did the methadone group (48% vs. 14%, p <.001). Consistent with this result, prior to release from Rikers, buprenorphine patients stated an intention to continue treatment after release more often than did methadone patients (93% vs. 44%, p <.001). Buprenorphine patients were also less likely than methadone patients to withdraw voluntarily from medication while in jail (3% vs. 16%, p <.05). There were no post-release differences between the buprenorphine and methadone groups in self-reported relapse to illicit opioid use, self-reported re-arrests, self-reported severity of crime or re-incarceration in jail. After initiating opioid agonist treatment in jail, continuing buprenorphine maintenance in the community appears to be more acceptable to offenders than continuing methadone maintenance. PMID:18930603

  11. Clinical Trials Methods for Evaluation of Potential Reduced Exposure Products

    PubMed Central

    Hatsukami, Dorothy K.; Hanson, Karen; Briggs, Anna; Parascandola, Mark; Genkinger, Jeanine M.; O'Connor, Richard; Shields, Peter

    2009-01-01

    Potential reduced exposure tobacco products (PREPs) may have promise in reducing tobacco-related morbidity or mortality or may promote greater harm to individuals or the population. Critical to determining the risks or benefits from these products are valid human clinical trial PREP assessment methods. Assessment involves determining the effects of these products on biomarkers of exposure and of effect, which serve as proxies for harm, and assessing the potential for consumer uptake and abuse of the product. This article raises the critical methodological issues associated with PREP assessment, reviews the methods that have been used to assess PREPs, and describes the strengths and limitations of these methods. Additionally, recommendations for clinical trials PREP assessment methods and future research directions in this area based on this review and on the deliberations from a National Cancer Institute sponsored Clinical Trials PREP Methods Workshop are provided. PMID:19959672

  12. Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial.

    PubMed

    Gonzalez, Henrik; Sunnerhagen, Katharina Stibrant; Sjöberg, Inger; Kaponides, Georgios; Olsson, Tomas; Borg, Kristian

    2006-06-01

    Survivors of poliomyelitis often develop increased or new symptoms decades after the acute infection, known as post-polio syndrome. Production of proinflammatory cytokines within the CNS indicates an underlying inflammatory process, accessible for immunomodulatory treatment. We did a multicentre, randomised, double-blind, placebo-controlled study of intravenous immunoglobulin in post-polio syndrome. 142 patients at four university clinics were randomly assigned infusion of either 90 g in total of intravenous immunoglobulin (n=73) or placebo (n=69) during 3 consecutive days, repeated after 3 months. Seven patients were withdrawn from the study. Thus, 135 patients were assessed per protocol. Primary endpoints were muscle strength in a selected study muscle and quality of life as measured with the SF-36 questionnaire (SF-36 PCS). Secondary endpoints were 6-minute walk test (6MWT), timed up and go (TUG), muscle strength in muscles not chosen as the study muscle, physical activity scale of the elderly (PASE), visual analogue scale (VAS) for pain, multidimensional fatigue inventory (MFI-20), balance, and sleep quality. Outcome tests were done immediately before the first infusion and 3 months after the second infusion. This study is registered with , number NCT00160082. Compared with baseline, median muscle strength differed by 8.3% between patients receiving intravenous immunoglobulin and placebo, in favour of the treatment group (p=0.029). SF-36 PCS did not differ significantly between the groups after treatment (p=0.321). Differences in the subscale vitality score (p=0.042) and PASE (p=0.018) favoured the active treatment group. MFI-20, TUG, muscle strength in the muscles not chosen as the study muscle, 6MWT, balance, and sleep quality did not differ between groups. For the whole study population there was no significant change in pain, as determined by VAS. Nevertheless, patients who reported pain at the study start improved in the intervention group but not in the

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

    PubMed

    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 <0.01. CTS improved between 6.7-16.8% (average 14.2%) and GAOTP between 8.6-17.1% (average 13.5%) for all domains. Using the control group as baseline, the intervention improved teamwork by 25% using CTS and 22% using GAOTP. Fewer technical skills were missed with the intervention (p<0.01). There was no statistical difference in the time technical skills were achieved. Assessors were more likely to recommend intervention teams 87.5% (77/88) than control teams 63.6% (56/88) p<0.01 to their friends or family. The SUS was 'Good' (69) becoming excellently 'Usable' (81.6) over the study period. We report a decision support system, which improved NTS when managing PPH. Lack of teamwork is often cited as the cause of failures in care and we report a usable technology that assists with and improves teamwork during

  14. Functional Dyspepsia Treatment Trial (FDTT): A double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics

    PubMed Central

    Talley, Nicholas J.; Locke, G. Richard; Herrick, Linda M.; Silvernail, Vickie M.; Prather, Charlene M.; Lacy, Brian E.; DiBaise, John K.; Howden, Colin W.; Brenner, Darren M.; Bouras, Ernest P.; El-Serag, Hashem B.; Abraham, Bincy P.; Moayyedi, Paul; Zinsmeister, Alan R.

    2014-01-01

    Background Functional dyspepsia (FD) is a common problem affecting up to 10–25% of individuals. FD accounts for significant health care costs and affects quality of life but has no definitive treatment. Objectives The Functional Dyspepsia Treatment Trial (FDTT) aims to test whether treatment with an antidepressant (amitriptyline or escitalopram) leads to improvement of symptoms in patients with moderate to severe FD. Design The FDTT is an international multicenter, parallel group, randomized, double-blind, placebo-controlled trial to evaluate whether 12 weeks of treatment with escitalopram or amitriptyline improves FD symptoms compared to treatment with placebo. Secondly, it is hypothesized that acceleration of solid gastric emptying, reduction of postprandial satiation, and enhanced gastric volume change with a meal will be significant positive predictors of short- and long-term outcomes for those on antidepressants vs. placebo. The third aim is to examine whether polymorphisms of GNβ3 and serotonin reuptake transporter influence treatment outcomes in FD patients receiving a tricyclic antidepressant, selective serotonin reuptake inhibitor therapy, or placebo. Methods The FDTT enrollment began in 2006 and is scheduled to randomize 400 patients by the end of 2012 to receive an antidepressant or placebo for 12 weeks, with a 6-month post-treatment follow-up. The study incorporates multiple validated questionnaires, physiological testing, and specific genetic evaluations. The protocol was approved by participating centers' Institutional Review Boards and an independent Data Safety Monitoring Board was established for monitoring to ensure patient safety and a single interim review of the data in December 2010 (ClinicalTrials.gov number NCT00248651). PMID:22343090

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

    PubMed Central

    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

  16. ICF Based Comprehensive Evaluation for Post-Acute Spinal Cord Injury.

    PubMed

    Nam, Hyung Seok; Kim, Kwang Dong; Shin, Hyung Ik

    2012-12-01

    To evaluate the feasibility of the ICF for initial comprehensive evaluation of early post-acute spinal cord injury. A comprehensive evaluation of 62 early post-acute spinal cord injury (SCI) patients was conducted by rehabilitation team members, such as physicians, physical therapists, occupational therapists, nutritionists, medical social-workers, and nurses. They recorded each of their evaluation according to the ICF first level classification. The contents of the comprehensive evaluation were linked to the ICF second level categories, retrospectively. The linked codes were analyzed descriptively and were also compared with the brief ICF core set for early post-acute SCI. In the evaluation of early post-acute SCI patients based on the ICF first level categories, 19 items from the body functions domain, such as muscle power functions (b730) and urination functions (b620), 15 items from the body structures domain, including spinal cord and related structures (s120), 11 items from the activities and participation domain, such as transferring oneself (d420) and walking (d450), and 9 items from the environmental factors domain, e.g., health professionals (e355), were linked to the ICF second level categories. In total, 82.4% of all contents were linked to the brief ICF core set. Prognosis insight, a personal factor not linkable to an ICF code, was mentioned in 29.0% of all patients. First level ICF categories can provide a structural base for a comprehensive evaluation in early post-acute spinal cord injury. However, frequently linked items, including the brief core set, as well as personal factors should be considered via a checklist in order to prevent the omission of significant contents.

  17. ICF Based Comprehensive Evaluation for Post-Acute Spinal Cord Injury

    PubMed Central

    Nam, Hyung Seok; Kim, Kwang Dong

    2012-01-01

    Objective To evaluate the feasibility of the ICF for initial comprehensive evaluation of early post-acute spinal cord injury. Method A comprehensive evaluation of 62 early post-acute spinal cord injury (SCI) patients was conducted by rehabilitation team members, such as physicians, physical therapists, occupational therapists, nutritionists, medical social-workers, and nurses. They recorded each of their evaluation according to the ICF first level classification. The contents of the comprehensive evaluation were linked to the ICF second level categories, retrospectively. The linked codes were analyzed descriptively and were also compared with the brief ICF core set for early post-acute SCI. Results In the evaluation of early post-acute SCI patients based on the ICF first level categories, 19 items from the body functions domain, such as muscle power functions (b730) and urination functions (b620), 15 items from the body structures domain, including spinal cord and related structures (s120), 11 items from the activities and participation domain, such as transferring oneself (d420) and walking (d450), and 9 items from the environmental factors domain, e.g., health professionals (e355), were linked to the ICF second level categories. In total, 82.4% of all contents were linked to the brief ICF core set. Prognosis insight, a personal factor not linkable to an ICF code, was mentioned in 29.0% of all patients. Conclusion First level ICF categories can provide a structural base for a comprehensive evaluation in early post-acute spinal cord injury. However, frequently linked items, including the brief core set, as well as personal factors should be considered via a checklist in order to prevent the omission of significant contents. PMID:23342313

  18. Evaluation of use of stage of tobacco epidemic to predict post-immigration smoking behaviors.

    PubMed

    Constantine, Melissa L; Adejoro, Oluwakayode O; D'Silva, Joanne; Rockwood, Todd H; Schillo, Barbara A

    2013-11-01

    This research uses the Lopez stage of tobacco epidemic model to evaluate post-immigration smoking behavior. Stage is a composite measure of tobacco norms of a country: smoking prevalence, cigarette consumption, and tobacco-related morbidity. The Lopez model characterizes the changing relationship between smoking prevalence and tobacco-related mortality and morbidity as a country progresses through the 4 successive stages of the tobacco epidemic. Survey data from Southeast Asian and Latino immigrants (from stage 1 and stage 2 countries) (n = 2,076) were used to evaluate stage of tobacco epidemic of country of emigration. Stage was compared with standard acculturation measures and community identification measures to understand post-immigration smoking behavior in the United States. Comparative analysis by stage and gender includes bivariate associations and logistic regression models to predict post-immigration smoking behavior. Males:Pre-immigration prevalence and consumption rates of our study sample conform to prevalence and consumption of stage 1 and stage 2 countries predicted by the Lopez model. Post-immigration smoking uptake is equivalent to pre-immigration uptake for stage 1 males. The uptake rate for stage 2 males post-immigration is significantly lower (22.1%) than pre-immigration uptake (41.4%). Stage is a statistically significant predictor of post-immigration smoking uptake (OR = 3.08, CI = 1.82-5.22, p < .01). Females:Stage of country of birth is not significantly predictive of post-migration smoking uptake. The finding of stage to be a strong predictor of post-immigration smoking behavior among males provides a promising measurement tool. Prevalence and consumption of females in our study sample support the need for revisions to the stage model.

  19. Evaluation of multisystemic therapy pilot services in the Systemic Therapy for At Risk Teens (START) trial: study protocol for a randomised controlled trial.

    PubMed

    Fonagy, Peter; Butler, Stephen; Goodyer, Ian; Cottrell, David; Scott, Stephen; Pilling, Stephen; Eisler, Ivan; Fuggle, Peter; Kraam, Abdullah; Byford, Sarah; Wason, James; Haley, Rachel

    2013-08-20

    There is an urgent need for clinically effective and cost-effective methods to manage antisocial and criminal behaviour in adolescents. Youth conduct disorder is increasingly prevalent in the UK and is associated with a range of negative outcomes. Quantitative systematic reviews carried out for the National Institute for Health and Clinical Excellence have identified multisystemic therapy, an intensive, multimodal, home-based, family intervention for youth with serious antisocial behaviour, as one of the most promising interventions for reducing antisocial or offending behaviour and improving individual and family functioning. Previous international trials of multisystemic therapy have yielded mixed outcomes, and it is questionable to what extent positive US findings can be generalised to a wider UK mental health and juvenile justice context. This paper describes the protocol for the Systemic Therapy for At Risk Teens (START) trial, a multicentre UK-wide randomised controlled trial of multisystemic therapy in antisocial adolescents at high risk of out-of-home placement. The trial is being conducted at 10 sites across the UK. Seven hundred participants and their families will be recruited and randomised on a 1:1 basis to multisystemic therapy or management as usual. Treatments are offered over a period of 3 to 5 months, with follow-up to 18 months post-randomisation. The primary outcome is out-of-home placement at 18 months. Secondary outcomes include offending rates, total service and criminal justice sector costs, and participant well-being and educational outcomes. Data will be gathered from police computer records, the National Pupil Database, and interview and self-report measures administered to adolescents, parents and teachers. Outcomes will be analysed on an intention-to-treat basis, using a logistic regression with random effects for the primary outcome and Cox regressions and linear mixed-effects models for secondary outcomes depending on whether the

  20. Comparison of Brunnstrom movement therapy and Motor Relearning Program in rehabilitation of post-stroke hemiparetic hand: a randomized trial.

    PubMed

    Pandian, Shanta; Arya, Kamal Narayan; Davidson, E W Rajkumar

    2012-07-01

    Motor recovery of the hand usually plateaus in chronic stroke patients. Various conventional and contemporary approaches have been used to rehabilitate the hand post-stroke. However, the evidence for their effectiveness is still limited. To compare the hand therapy protocols based on Brunnstrom approach and motor relearning program in rehabilitation of the hand of chronic stroke patients. Randomized trial. Outpatients attending the occupational therapy department of a rehabilitation institute. 30 post-stroke subjects (35.06 ± 14.52 months) were randomly assigned into two equal groups (Group A and Group B), Outcome Measures: Brunnstrom recovery stages of hand (BRS-H), Fugl-Meyer assessment: wrist and hand (FMA-WH). Group A received Brunnstrom hand manipulation (BHM). BHM is the hand treatment protocol of the Brunnstrom movement therapy, which uses synergies and reflexes to develop voluntary motor control. Group B received the Motor Relearning Program (MRP) based hand protocol. MRP is the practice of specific motor skills, which results in the ability to perform a task. Active practice of context-specific motor task such as reaching and grasping helps regain the lost motor functions. Both the therapy protocols were effective in rehabilitation of the hand (BRS-H; p = 0.003 to 0.004, FMA-WH; p < 0.001). However, the results were statistically significant in favor of group A undergoing BHM for FMA-WH (p < 0.004) and FMA item VIII (hand motor recovery) (p < 0.033). BHM was found to be more effective than MRP in rehabilitation of the hand in chronic post-stroke patients. Copyright © 2011 Elsevier Ltd. All rights reserved.

  1. Costs and effectiveness of pre- and post-operative home physiotherapy for total knee replacement: randomized controlled trial.

    PubMed

    Mitchell, Caroline; Walker, Jane; Walters, Stephen; Morgan, Anne B; Binns, Teena; Mathers, Nigel

    2005-06-01

    To assess the effectiveness of pre- and post-operative physiotherapy at home for unilateral total knee replacement (TKR). In this pragmatic randomized controlled trial set in participants' homes (four primary care trust areas) and physiotherapy outpatients in a South Yorkshire teaching hospital trust, 160 osteoarthritis patients waiting for unilateral TKR were randomly allocated to intervention (home) group (n=80) or control (hospital outpatient) group (n=80). The intervention group had pre- and post-operative home visits for assessment and treatment by a community physiotherapist. Outcome measures were health-related quality of life (HRQoL), measured by the Western Ontario McMaster Osteoarthritis index (WOMAC) and the Short Form 36 health survey (SF-36) pre-operatively and at 12 weeks post-TKR operation; patient satisfaction; and NHS resource use. No significant differences were observed between the two treatment groups in the primary outcome measure, the WOMAC pain score, or any other HRQoL score. The home group had a significantly greater mean number of physiotherapy sessions than the hospital group [mean difference 5.2 sessions, 95% confidence interval (CI)=-6.3 to -4.1; P=0.001]. There was no significant difference in the total NHS costs per patient between groups. However, home physiotherapy for TKR was significantly more expensive (mean difference-pound136.5, 95% CI=- pound160 to-pound113; P=0.001). Patients were equally satisfied with physiotherapy at home or in hospital; however, more of the home group would choose their location for physiotherapy again. Although home physiotherapy was as effective and as acceptable to patients as hospital outpatient physiotherapy for unilateral TKR, it was more expensive. Additional pre-operative home physiotherapy did not improve patient-perceived health outcomes.

  2. A randomized, double-blind, placebo-controlled trial comparing pethidine to metamizol for treatment of post-anaesthetic shivering

    PubMed Central

    MONSÓ, A.; RIUDEUBAS, J.; BARBAL, F.; LAPORTE, J-R.; ARNAU, J. M.

    1996-01-01

    1Shivering is frequent during the post-anaesthetic recovery period, and there is no clear consensus about the best strategy for its treatment. We tested the efficacy of two commonly used analgesic drugs, pethidine and metamizol. 2A randomized, double-blind, placebo-controlled clinical trial was performed, including 104 adult patients who presented with post-anaesthetic shivering during the recovery from general anaesthesia. They were randomized to receive placebo (n=32), metamizol 25 mg kg−1 (n=37), or pethidine 0.4 mg kg−1 (n=35). The response to treatment was assessed 5, 15 and 45 min after drug administration, and the main outcome variable was complete suppression of shivering. 3The efficacy at 5, 15 and 45 min was as follows: placebo 6%, 16% and 37%; metamizol 13.5%, 32% and 76%, and pethidine 89%, 91% and 89%. With both active drugs the efficacy at all three time intervals was significantly higher than that with placebo (P<0.05). The differences (at 5 and 15, but not at 45 min) between pethidine and metamizol were statistically significant (P<0.05). Both drugs were well tolerated. 4The persistence of shivering at 45 min in two thirds of placebo-treated patients indicates that drug treatment is worthwhile; metamizol produces a better post-anaesthetic shivering response than placebo, especially 15 and 45 min after drug administration; the efficacy of pethidine was the highest and the response to it appeared more quickly; however, at 45 min it was similar to that observed with metamizol. 5Both metamizol and pethidine suppress postanaesthetic shivering, but the latter induces a quicker and more reliable response. PMID:8877020

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

    PubMed

    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

  4. Designing a trial to evaluate potential treatments for apathy in dementia: the apathy in dementia methylphenidate trial (ADMET).

    PubMed

    Drye, Lea T; Scherer, Roberta W; Lanctôt, Krista L; Rosenberg, Paul B; Herrmann, Nathan; Bachman, David; Mintzer, Jacobo E

    2013-06-01

    Research on efficacious treatments for apathy in Alzheimer disease has been hindered by a lack of consensus diagnosis, difficulties in measurement, and studies with small sample sizes. In designing the Apathy in Dementia Methylphenidate Trial (ADMET), a trial to evaluate the efficacy and safety of methylphenidate for the treatment of apathy in Alzheimer disease, we encountered the following issues: defining and measuring apathy, distinguishing apathy and depression, determining an appropriate test treatment, selecting relevant secondary outcomes, recruiting participants, and deciding on a suitable method for treatment unmasking. ADMET is a 6-week randomized, double-masked, placebo-controlled multicenter clinical trial with two parallel treatment groups assigned in a 1:1 ratio with randomization stratified by clinical center. The recruitment goal is 60 randomized participants over 2 years. The primary outcomes are change in apathy severity as measured by the Apathy Evaluation Scale and the Alzheimer Disease Cooperative Study-Clinical Global Impression of Change. The design decisions made for ADMET are important elements to be considered in trials assessing the safety and efficacy of medications for clinically significant apathy in Alzheimer disease. Copyright © 2013 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  5. Glutamine and antioxidants in the critically ill patient: a post hoc analysis of a large-scale randomized trial.

    PubMed

    Heyland, Daren K; Elke, Gunnar; Cook, Deborah; Berger, Mette M; Wischmeyer, Paul E; Albert, Martin; Muscedere, John; Jones, Gwynne; Day, Andrew G

    2015-05-01

    The recent large randomized controlled trial of glutamine and antioxidant supplementation suggested that high-dose glutamine is associated with increased mortality in critically ill patients with multiorgan failure. The objectives of the present analyses were to reevaluate the effect of supplementation after controlling for baseline covariates and to identify potentially important subgroup effects. This study was a post hoc analysis of a prospective factorial 2 × 2 randomized trial conducted in 40 intensive care units in North America and Europe. In total, 1223 mechanically ventilated adult patients with multiorgan failure were randomized to receive glutamine, antioxidants, both glutamine and antioxidants, or placebo administered separate from artificial nutrition. We compared each of the 3 active treatment arms (glutamine alone, antioxidants alone, and glutamine + antioxidants) with placebo on 28-day mortality. Post hoc, treatment effects were examined within subgroups defined by baseline patient characteristics. Logistic regression was used to estimate treatment effects within subgroups after adjustment for baseline covariates and to identify treatment-by-subgroup interactions (effect modification). The 28-day mortality rates in the placebo, glutamine, antioxidant, and combination arms were 25%, 32%, 29%, and 33%, respectively. After adjusting for prespecified baseline covariates, the adjusted odds ratio of 28-day mortality vs placebo was 1.5 (95% confidence interval, 1.0-2.1, P = .05), 1.2 (0.8-1.8, P = .40), and 1.4 (0.9-2.0, P = .09) for glutamine, antioxidant, and glutamine plus antioxidant arms, respectively. In the post hoc subgroup analysis, both glutamine and antioxidants appeared most harmful in patients with baseline renal dysfunction. No subgroups suggested reduced mortality with supplements. After adjustment for baseline covariates, early provision of high-dose glutamine administered separately from artificial nutrition was not beneficial and may be

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

    PubMed

    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 =

  7. An up to 3-Year Controlled Clinical Trial Comparing the Outcome of Glass Fiber Posts and Composite Cores with Gold Alloy-Based Posts and Cores for the Restoration of Endodontically Treated Teeth.

    PubMed

    Zicari, Francesca; Van Meerbeek, Bart; Debels, Elke; Lesaffre, Emmanuel; Naert, Ignace

    2011-01-01

    This controlled clinical trial aimed to compare the 3-year outcomes of glass fiber posts and composite cores with gold alloy-based posts and cores for the restoration of endodontically treated teeth. One hundred forty-four patients in need of 205 restorations on endodontically treated teeth were selected and followed for 7 to 37 months (mean: 21 ± 9 months). The teeth were primarily stratified based on the remaining tissue available to restore the tooth core with or without a post. Then, randomization allocated the teeth to either test group 1 (prefabricated glass fiber posts), test group 2 (custom-made glass fiber posts), or test group 3 (composite cores without posts). The control group consisted of gold alloy-based posts and cores. All posts/cores were covered with all-ceramic single crowns. Failures were either absolute, such as root fractures or irreparable fractures of the post/core, or relative, such as loss of post retention or reparable fractures of the core. Success and survival probability lifetime curves, corrected for clustering, were drawn for the entire data set. The recall rate at 3 years was 97.1%. Absolute failures consisted of two root fractures and one endodontic failure, while relative failures included three instances of retention loss of the post/core and one post fracture. Because of the low number of events, no statistical tests were performed. The success and survival probabilities over all groups together at 3 years amounted to 91.7% and 97.2%, respectively. After being followed for up to 3 years, both cast gold and composite post and core systems performed well clinically. Longer follow-up times are needed to detect possible significant differences. Int J Prosthodont 2011;24:363-372.

  8. Prior human papillomavirus-16/18 AS04-adjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: Post-hoc analysis from a randomized controlled trial.

    PubMed

    Garland, Suzanne M; Paavonen, Jorma; Jaisamrarn, Unnop; Naud, Paulo; Salmerón, Jorge; Chow, Song-Nan; Apter, Dan; Castellsagué, Xavier; Teixeira, Júlio C; Skinner, S Rachel; Hedrick, James; Limson, Genara; Schwarz, Tino F; Poppe, Willy A J; Bosch, F Xavier; de Carvalho, Newton S; Germar, Maria Julieta V; Peters, Klaus; Del Rosario-Raymundo, M Rowena; Catteau, Grégory; Descamps, Dominique; Struyf, Frank; Lehtinen, Matti; Dubin, Gary

    2016-12-15

    We evaluated the efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in preventing HPV-related disease after surgery for cervical lesions in a post-hoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15-25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPV-16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present post-hoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPV-related cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more post-surgery. Other outcomes included the incidence of HPV-related CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more post-surgery. Of the total vaccinated cohort of 18,644 women (vaccine = 9,319; control = 9,325), 454 (vaccine = 190, control = 264) underwent an excisional procedure during the trial. Efficacy 60 days or more post-surgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (-21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more post-surgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPV-16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+. © 2016 UICC.

  9. 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.

    PubMed

    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).

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

    PubMed Central

    Gluck, Iris; Feng, Felix Y; Lyden, Teresa; Haxer, Marc; Worden, Francis; Chepeha, Douglas B.; Eisbruch, Avraham

    2009-01-01

    Purpose Reporting long-term toxicities in trials of chemo-irradiation (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 1) patient-reported dysphagia (PRD), and 2) objective swallowing dysfunction through videofluoroscopy (VF), in patients with various grades of maximal observer-reported dysphagia (ORD). Methods 62 HNC patients completed quality-of-life questionnaires periodically through 12m post-CRT. Five PRD items were selected: three dysphagia-specific questions, an Eating-Domain, and “Overall Bother”. They underwent VF at 3m and 12m, 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 to 2 at 3m but similar at 12m. 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 12m. 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. PMID:19783380

  11. The construction and evaluation of new educational software for nursing diagnoses: a randomized controlled trial.

    PubMed

    Sousa, Vanessa E C; Lopes, Marcos V O; Ferreira, Gabriele L; Diniz, Camila M; Froes, Nathaly B M; Sobreira, Bianca A

    2016-01-01

    Student nurses often have difficulties with diagnostic inferences. To achieve high accuracy nursing diagnoses, effective learning strategies are required. To describe the construction and evaluation of new educational software called Wise Nurse, which was developed to increase the capacity of student nurses to identify nursing diagnoses (NDx) and to establish relationships between NDx, defining characteristics (DC), and related factors (RF). Randomized controlled trial. Participants were 2nd to 4th year student nurses from an undergraduate program at a university in Brazil. Of the 47 recruited students, 37 completed the survey. Students were randomly assigned to test the software (experimental group) and to solve printed clinical cases (comparison group). A pretest and post-test were applied before and after the experiment. Statistical analyses of the students' performance in the tests were conducted. The primary outcome was the students' progress in solving questions and clinical cases regarding NDx. The System Usability Scale was used to measure the software's ease of use. No significant difference was found between the experimental and comparison groups before and after the experiment. The average students' performance in identifying RF and NDx was higher than in identifying DC. The post-test score was higher than the pretest score in both groups (P=0.022). The usability score was good (average score 83.75, N=20). The use of Wise Nurse supported an improvement in student diagnostic reasoning equivalent to that of the traditional NDx training, but the software stands out as an innovative teaching tool. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. Economic evaluation alongside the Premature Infants in Need of Transfusion randomised controlled trial.

    PubMed

    Kamholz, Karen L; Dukhovny, Dmitry; Kirpalani, Haresh; Whyte, Robin K; Roberts, Robin S; Wang, Na; Mao, WenYang; Zupancic, John A F

    2012-03-01

    The Premature Infants in Need of Transfusion (PINT) Outcome Study showed no significant difference in the primary outcome of death or neurodevelopmental impairment (NDI) in extremely low birthweight (ELBW) infants. However, a post-hoc analysis expanding the definition of NDI to include borderline intellectual functioning (Mental Development Index (MDI) <85) found an improvement in outcomes in the group maintained at higher haemoglobin levels. To determine the cost effectiveness of more frequent red blood cell transfusions (high-Hb threshold) compared with less frequent transfusions (low-Hb threshold) in ELBW infants. The authors performed an economic evaluation using patient-level data collected during the PINT randomised trial. The authors measured comprehensive costs from a third-party payer's perspective over a time horizon from birth through 18-21 months corrected age. The average total cost in the high-Hb threshold group was CAN$149 767 compared with CAN$150 227 in the low-Hb threshold group (difference of CAN$460, p=0.96). Cost-effectiveness analysis estimated savings of CAN$6879 for every additional infant surviving without severe NDI. There was a 48% chance that the high-Hb threshold reduced costs while improving outcome and a 90% chance that it would be cost effective at a willingness-to-pay threshold of CAN$250 000 per additional survivor without severe NDI. Post-hoc analysis defining cognitive delay as MDI score <85, instead of <70, revealed savings in the high-Hb threshold group of CAN$4457 per additional survivor without NDI. Results were robust to deterministic sensitivity analyses. A high-Hb threshold for transfusion, as measured in ELBW PINT study infants through 18 months corrected gestational age, may be an economically appealing intervention. The estimates were associated with moderate statistical uncertainty that should be targeted in larger, future studies.

  13. Standardized ultrasound evaluation of carotid stenosis for clinical trials: University of Washington Ultrasound Reading Center

    PubMed Central

    2010-01-01

    Introduction Serial monitoring of patients participating in clinical trials of carotid artery therapy requires noninvasive precision methods that are inexpensive, safe and widely available. Noninvasive ultrasonic duplex Doppler velocimetry provides a precision method that can be used for recruitment qualification, pre-treatment classification and post treatment surveillance for remodeling and restenosis. The University of Washington Ultrasound Reading Center (UWURC) provides a uniform examination protocol and interpretation of duplex Doppler velocity measurements. Methods Doppler waveforms from 6 locations along the common carotid and internal carotid artery path to the brain plus the external carotid and vertebral arteries on each side using a Doppler examination angle of 60 degrees are evaluated. The UWURC verifies all measurements against the images and waveforms for the database, which includes pre-procedure, post-procedure and annual follow-up examinations. Doppler angle alignment errors greater than 3 degrees and Doppler velocity measurement errors greater than 0.05 m/s are corrected. Results Angle adjusted Doppler velocity measurements produce higher values when higher Doppler examination angles are used. The definition of peak systolic velocity varies between examiners when spectral broadening due to turbulence is present. Examples of measurements are shown. Discussion Although ultrasonic duplex Doppler methods are widely used in carotid artery diagnosis, there is disagreement about how the examinations should be performed and how the results should be validated. In clinical trails, a centralized reading center can unify the methods. Because the goals of research examinations are different from those of clinical examinations, screening and diagnostic clinical examinations may require fewer velocity measurements. PMID:20822530

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

    SciTech Connect

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

    2010-07-01

    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.

  15. Evaluation of a Blocked-Trials Procedure to Establish Complex Stimulus Control over Intraverbal Responses in Children with Autism

    ERIC Educational Resources Information Center

    Ingvarsson, Einar T.; Kramer, Rachel L.; Carp, Charlotte L.; Pétursdóttir, Anna I.; Macias, Heather

    2016-01-01

    We evaluated the use of a blocked-trials procedure to establish complex stimulus control over intraverbal responses. The participants were four young boys with a diagnosis of autism who had struggled to master intraverbals. The blocked-trials procedures involved presentation of stimuli in separate trial blocks. The trial blocks gradually reduced…

  16. Evaluation of a Blocked-Trials Procedure to Establish Complex Stimulus Control over Intraverbal Responses in Children with Autism

    ERIC Educational Resources Information Center

    Ingvarsson, Einar T.; Kramer, Rachel L.; Carp, Charlotte L.; Pétursdóttir, Anna I.; Macias, Heather

    2016-01-01

    We evaluated the use of a blocked-trials procedure to establish complex stimulus control over intraverbal responses. The participants were four young boys with a diagnosis of autism who had struggled to master intraverbals. The blocked-trials procedures involved presentation of stimuli in separate trial blocks. The trial blocks gradually reduced…

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

    PubMed

    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.

  18. Daily Fluid Intake and Outcomes in Kidney Recipients: Post hoc analysis from the randomized ABCAN trial

    PubMed Central

    Weber, M; Berglund, D; Reule, S; Jackson, S; Matas, AJ; Ibrahim, HN

    2015-01-01

    Generous and even excessive fluid intake is routinely recommended to kidney transplant recipients despite minimal evidence to support this practice. We hypothesized that increased fluid intake, ascertained by 24-hour urine volume output, may adversely affect graft outcomes as it would impose an extra workload on a limited number of nephrons. Kidney transplant recipients who were randomized to losartan vs. placebo in the ABCAN trial (n=153) underwent baseline, five-year biopsies and annual iothalamate GFR assessment. Recipients with higher urine volume at randomization had higher urinary sodium and also higher urinary protein. The proportion using diuretics or CNI based regimens were similar across urinary volume tertiles. The highest urinary volume tertile (>2.56 L/day) did not predict the development of interstitial volume doubling or ESRD from IF/TA (OR=3.52, 95% CI 0.4, 38.15, p=0.26), interstitial volume doubling or all-cause ESRD (OR=7.04, 95% CI 0.66, 74.87, p=0.10), and was not associated with the conventional endpoint of doubling serum creatinine, all cause ESRD, or death (OR=0.89, 95% CI 0.21, 3.71, p=0.87). These results suggest that the current practice of liberal fluid intake may not be beneficial in low risk and mostly Caucasian transplant recipients. PMID:25619874

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

    PubMed

    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.

  20. Evaluation of an Innovative Post-Arrest Diversion Program: 12-Month Recidivism Analysis

    ERIC Educational Resources Information Center

    Dembo, Richard; Walters, Wansley; Wareham, Jennifer; Burgos, Catherimarty; Schmeidler, James; Hoge, Robert; Underwood, Lee

    2008-01-01

    We report the results of an evaluation study of a diversion program, operated by the Miami-Dade County Juvenile Assessment Center in Florida. The Post-Arrest Diversion (PAD) program represents an innovative approach to treatment and intervention within the juvenile justice system that utilizes standardized psychosocial risks and needs assessment…

  1. Utilizing Emergency Departments as Learning Spaces through a Post-Occupancy Evaluation

    ERIC Educational Resources Information Center

    Guinther, Lindsey Lawry; Carll-White, Allison

    This case study describes the use of an emergency department as a learning space for interior design students. Kolb's (1984; 2005) framework identifies the characteristics of experiential learning and learning spaces, serving as the bridge to unify learning styles and the learning environment. A post-occupancy evaluation was conducted with…

  2. Evaluation of an Innovative Post-Arrest Diversion Program: 12-Month Recidivism Analysis

    ERIC Educational Resources Information Center

    Dembo, Richard; Walters, Wansley; Wareham, Jennifer; Burgos, Catherimarty; Schmeidler, James; Hoge, Robert; Underwood, Lee

    2008-01-01

    We report the results of an evaluation study of a diversion program, operated by the Miami-Dade County Juvenile Assessment Center in Florida. The Post-Arrest Diversion (PAD) program represents an innovative approach to treatment and intervention within the juvenile justice system that utilizes standardized psychosocial risks and needs assessment…

  3. Evaluation of a Post-PharmD Residency on Call/Morning Report Program.

    ERIC Educational Resources Information Center

    Engle, Janet P.; And Others

    1988-01-01

    All present and past participants in a post-PharmD pharmacy residency program were surveyed in a program evaluation. The residency was comprised of rotations in the emergency room and each resident was required to meet for one hour each day with assigned clinical pharmacy faculty for the morning report. (Author/MLW)

  4. Using the facial grimace scale to evaluate rabbit wellness in post-procedural monitoring.

    PubMed

    Hampshire, Victoria; Robertson, Sheilah

    2015-07-01

    Rabbits are commonly used in biomedical research and might undergo potentially painful procedures during the course of a study. This column discusses the rabbit facial grimace scale as a tool for monitoring post-procedural pain and explains how it can be incorporated into a worksheet for evaluating rabbit wellness.

  5. The Collection of Post-Release Outcome Data for the Evaluation of Correctional Education Programs

    ERIC Educational Resources Information Center

    Lichtenberger, Eric; Ogle, J. Todd

    2006-01-01

    This article highlights several issues related to the collection of post-release outcome data in the evaluation of correctional education programs and identifies the strengths and weaknesses of the different methods of collecting data related to recidivism, employment/earnings, and further education/training. The use of traditional follow-up in…

  6. Assessing the Learning Value of Campus Open Spaces through Post-Occupancy Evaluations

    ERIC Educational Resources Information Center

    Spooner, David

    2008-01-01

    The idea that the physical design and configuration of a campus can elicit and support studying behavior has important ramifications, as all academic institutions underscore learning in their mission statements. This article evaluates the learning value, or ability of a campus space to support studying behavior, through the use of a post-occupancy…

  7. Assessing the Learning Value of Campus Open Spaces through Post-Occupancy Evaluations

    ERIC Educational Resources Information Center

    Spooner, David

    2008-01-01

    The idea that the physical design and configuration of a campus can elicit and support studying behavior has important ramifications, as all academic institutions underscore learning in their mission statements. This article evaluates the learning value, or ability of a campus space to support studying behavior, through the use of a post-occupancy…

  8. Shrinkage evaluation of heavyweight and lightweight polypropylene meshes in inguinal hernia repair: a randomized controlled trial.

    PubMed

    Silvestre, A C; de Mathia, G B; Fagundes, D J; Medeiros, L R; Rosa, M I

    2011-12-01

    One of the current complications in inguinal repair is shrinkage following the use of mesh. The selected mesh material, heavyweight (HWM) mesh or lightweight (LWM) mesh, is associated with the frequency of shrinkage. The aim of this study was to investigate shrinkage of these two types of mesh in a controlled trial of male inguinal hernia repair. Thirty-two healthy men with primary unilateral inguinal hernias (Nyhus classification), who presented at São José Hospital of Criciúma, Brazil, underwent the Lichtenstein procedure. In total, 16 polypropylene HWM (105 g/m(2)) and 16 partially absorbable LWM (28 g/m(2)) were implanted into randomly selected patients. On post-operative days 1, 30, 60 and 90, the area of the mesh was evaluated by digital radiography. The study randomized 32 patients and analyzed 30 patients--15 for each type of mesh. At baseline, there were no differences between groups. There were significant differences between the two meshes when comparing the total area initially and on postoperative day 90 (P = 0.001). The HWM had significantly less area initial area, as compared with 90 days postoperatively (P = 0.04). Shrinkage was significantly higher for HWM, although the difference was not large.

  9. Impact of endotracheal intubation on septic shock outcome: A post hoc analysis of the SEPSISPAM trial.

    PubMed

    Delbove, Agathe; Darreau, Cédric; Hamel, Jean François; Asfar, Pierre; Lerolle, Nicolas

    2015-12-01

    The objective of the study to is to determine the characteristics associated with endotracheal intubation in septic shock patients. This is a post hoc analysis of the database of the SEPSISPAM study, including patients with septic shock. Among the 776 patients, 633 (82%) were intubated within 12 hours of study inclusion (early intubation), 113 (15%) were never intubated, and 30 (4%) had delayed intubation. Intensive care units (ICUs) were classified according to frequency of early intubation: early intubation less than 80% of patients (lowest frequency: 7 ICUs, 254 patients), 80% to 90% (middle frequency: 5 ICUs, 170 patients), and greater than 90% (highest frequency: 6 ICUs, 297 patients). Type of ICU, pulmonary infection, lactate greater than 2 mmol/L, lower Pao2/fraction of inspired oxygen ratio, lower Glasgow score, and absence of immunosuppression were independently associated with early intubation. Patients never intubated had a lower initial severity and a low mortality rate. In comparison to patients intubated early, patients with delayed intubation had had fewer days alive without organ support by day 28. Intensive care units with the highest frequency of early intubation had a higher mortality rate in comparison to ICUs with middle frequency of early intubation. A nonsignificant increased mortality was observed in ICU with lowest frequency of early intubation. Practices regarding the place of endotracheal intubation in septic shock may impact outcome. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Evaluation of four cementation strategies on the push-out bond strength between fiber post and root dentin.

    PubMed

    Bergoli, Cesar Dalmolin; Amaral, Marina; Druck, Carolina Ceolin; Valandro, Luiz Felipe

    2011-01-01

    This trial used push-out testing to evaluate four different fiber post cementation strategies. Specimens of bovine mandibular teeth were randomly allocated into four groups according to cementation strategies (n = 10): ScotchBond MultiPurpose and RelyX ARC (Group 1); AdheSE and Multilink Automix (Group 2); phosphoric acid and RelyX U100 (Group 3); and RelyX U100 (Group 4). Four slices from each specimen (2.0 mm thick) were obtained for the push-out test. All slices were analyzed for failure mode after testing. A one-way ANOVA showed differences between the groups (P = 0.002). A Tukey test indicated that Group 1 had the highest bond strength values (13.96 ± 6.41 MPa). Groups 2 (6.58 ± 2.14 MPa), 3 (5.85 ± 2.57 MPa), and 4 (8.19 ± 2.28 MPa) had similar bond strengths, but all of them were lower than Group 1. A three-step total etching adhesive system, associated with a conventional resin cement, might be a good alternative for fiber post cementation.

  11. A Neurofeedback-Based Intervention to Reduce Post-Operative Pain in Lung Cancer Patients: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Marzorati, Chiara; Casiraghi, Monica; Spaggiari, Lorenzo; Pravettoni, Gabriella

    2015-01-01

    Background Thoracic surgery appears to be the treatment of choice for many lung cancers. Nevertheless, depending on the type of surgery, the chest area may be painful for several weeks to months after surgery. This painful state has multiple physical and psychological implications, including respiratory failure, inability to clear secretions by coughing, and even anxiety and depression that have negative effects on recovery. Objective The aim of this study is to evaluate the effect of a neurofeedback-based intervention on controlling acute post-surgery pain and improving long-term recovery in patients who undergo thoracotomy for lung resection for non-small cell lung cancer (NSCLC) at an academic oncologic hospital. Methods This study will be based on a 2-parallel group randomized controlled trial design, intervention versus usual care, with multiple in-hospital assessments and 2 clinical, radiological, and quality of life follow-ups. Participants will be randomized to either the intervention group receiving a neurofeedback-based relaxation training and usual care, or to a control group receiving only usual care. Pain intensity is the primary outcome and will be assessed using the Numeric Pain Rating Scale (NRS) in the days following the operation. Secondary outcomes will include the effect of the intervention on hospital utilization for pain crisis, daily opioid consumption, anxiety, patient engagement, blood test and chest x-ray results, and long-term clinical, radiological, and quality of life evaluations. Outcome measures will be repeatedly taken during hospitalization, while follow-up assessments will coincide with the follow-up visits. Pain intensity will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations. Results We expect to have results for this study before the end of 2016. Conclusions The proposed innovative, neurofeedback- and relaxation-based approach to support post

  12. To evaluate and compare the effect of different Post Surface treatments on the Tensile Bond Strength between Fiber Posts and Composite Resin.

    PubMed Central

    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 interfacial strength between fiber post and composite, as core build-up material after different surface treatments of fiber posts. Materials & Methods:Twenty fiber posts were split into four groups off five each according to different surface treatments viz. Group I-(Negative Control), Group II-Silanization (Positive control), Group III-(37% Phosphoric Acid & Silanization) ,Group IV- (10% Hydrogen Peroxide and Silanization). With the preformed plastic mould, a core of dual cure composite resin around the fiber post having the uniform thickness was created. Tensile bond strength of each specimen was measured under Universal Testing Machine (UTM) at the cross head speed of 3mm/min. Results: The results achieved with 10% Hydrogen peroxide had a marked effect on micro tensile bond strength values between the tested materials. Conclusion: Immense enhancement in the silanization efficiency of quartz fiber phase was observed with different surface chemical treatment of the resin phase of fiber posts with the marked increase in the micro-tensile bond strength between fiber post and composite core. How to cite this article: Shori D, Pandey S, Kubde R, Rathod Y, Atara R, Rathi S. To evaluate and compare the effect of different Post Surface treatments on the Tensile Bond Strength between Fiber Posts and Composite Resin. J Int Oral Health 2013; 5(5):27-32. PMID:24324301

  13. To evaluate and compare the effect of different Post Surface treatments on the Tensile Bond Strength between Fiber Posts and Composite Resin.

    PubMed

    Shori, Deepa; Pandey, Swapnil; Kubde, Rajesh; Rathod, Yogesh; Atara, Rahul; Rathi, Shravan

    2013-10-01

    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 interfacial strength between fiber post and composite, as core build-up material after different surface treatments of fiber posts. Twenty fiber posts were split into four groups off five each according to different surface treatments viz. Group I-(Negative Control), Group II-Silanization (Positive control), Group III-(37% Phosphoric Acid & Silanization) ,Group IV- (10% Hydrogen Peroxide and Silanization). With the preformed plastic mould, a core of dual cure composite resin around the fiber post having the uniform thickness was created. Tensile bond strength of each specimen was measured under Universal Testing Machine (UTM) at the cross head speed of 3mm/min. The results achieved with 10% Hydrogen peroxide had a marked effect on micro tensile bond strength values between the tested materials. Immense enhancement in the silanization efficiency of quartz fiber phase was observed with different surface chemical treatment of the resin phase of fiber posts with the marked increase in the micro-tensile bond strength between fiber post and composite core. Shori D, Pandey S, Kubde R, Rathod Y, Atara R, Rathi S. To evaluate and compare the effect of different Post Surface treatments on the Tensile Bond Strength between Fiber Posts and Composite Resin. J Int Oral Health 2013; 5(5):27-32.

  14. Improving psychological adjustment following a first episode of psychosis: a randomised controlled trial of cognitive therapy to reduce post psychotic trauma symptoms.

    PubMed

    Jackson, C; Trower, P; Reid, I; Smith, J; Hall, M; Townend, M; Barton, K; Jones, J; Ross, K; Russell, R; Newton, E; Dunn, G; Birchwood, M

    2009-06-01

    There are few evaluated psychological interventions or theoretical approaches which are specifically aimed at reducing problems related to adjustment and adaptation following a first episode of psychosis. The present study tests the efficacy of a form of CBT (Cognitive Recovery Intervention; CRI) in reducing trauma, depression and low self esteem following a first episode of psychosis, in a single-blind randomised controlled trial. A total of 66 patients who had recently experienced a first episode of psychosis were randomly assigned to CRI or treatment as usual (TAU) and followed up at 6 and 12 months. People receiving CRI tended to have lower levels of post-intervention trauma symptoms and demonstrated greater improvement than those receiving TAU alone. This was especially the case at 6 months for those with high pre-treatment levels of trauma. There was, however, no advantage for the CRI group with regards to reduced depression or improved self esteem. In conclusion, CRI appears to be an effective intervention to help young people adapt to the traumatic aspects of a first episode of psychosis although further evaluation in a larger study is warranted.

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

    PubMed

    Winstein, Carolee J; Wolf, Steven L; Dromerick, Alexander W; Lane, Christianne J; Nelsen, Monica A; Lewthwaite, Rebecca; Blanton, Sarah; Scott, Charro; Reiss, Aimee; Cen, Steven Yong; Holley, Rahsaan; Azen, Stanley P

    2013-01-11

    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. Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log

  16. Evaluation of an Intervention among Adolescents to Reduce Preventive Misconception in HIV Vaccine Clinical Trials

    PubMed Central

    Lally, Michelle; Goldsworthy, Richard; Sarr, Moussa; Kahn, Jessica; Brown, Larry; Peralta, Ligia; Zimet, Greg

    2014-01-01

    Purpose Placebo and randomization are important concepts that must be understood before youth can safely participate in HIV vaccine studies or other biomedical trials for HIV prevention. These concepts are central to the phenomenon of preventive misconception which may be associated with an increase in risk behavior among study participants related to mistaken beliefs. Persuasive messaging, traditionally used in the field of marketing, could enhance educational efforts associated with randomized clinical trials. Methods Two educational brochures were designed to increase knowledge about HIV vaccine clinical trials via 1 and 2-sided persuasive messaging. Through the Adolescent Medicine Trials Network, 120 youth were enrolled, administered a mock HIV vaccine trial consent, and then randomized to receive either no supplemental information or one of the two brochures. Results The 2-sided brochure group in which common clinical trial misconceptions were acknowledgedand then refuted had significantly higher scores on knowledge of randomization and interpretation of side effects than the consent-only control group, and willingness to participate in an HIV vaccine trial was not decreased with the use of this brochure. Conclusion Two sided persuasive messaging improves understanding of the concepts of randomization and placebo among youth who would consider participating in an HIV vaccine trial. Further evaluation of this approach should be considered for at-risk youth participating in an actual trial of a biomedical intervention for HIV prevention. PMID:24613097

  17. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis

    PubMed Central

    2010-01-01

    inhibits physical function and influences patient perception of disease severity in hand OA. These results also suggest that any intervention to relieve the pain of hand OA may improve function and patient perception of disease severity, despite the absence of a disease-modifying mechanism of action. Trial registration Clinicaltrials.gov NCT00171652, NCT00171665. PMID:20064249

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

    PubMed

    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.

  19. Comparison of Two Techniques for Evaluation of Coronal Leakage Along of a Glass Fiber Post

    PubMed Central

    Sadighpour, L.; Rezaei, S.; Geramipanah, F.; Mohammadi, M.; Choubchian, S.

    2010-01-01

    Objective: Contradictory results have been reported over microleakage studies of restorative materials and methods. Despite the number of publications on leakage there are few evidences comparing the different microleakage evaluation methods. The purpose of the present study was to compare the clearing technique and longitudinal sectioning in the evaluation of dye penetration along a glass fiber post. Materials and Methods: Fifteen single-rooted human teeth were endontically prepared and obturated with gutta percha points and a resin based sealer (AH26). A glass fiber post (Glassix) was cemented into each post space with a dual polymerizing resin cement (Varilink II) and the composite core (Tetric Ceram) was fabricated. Specimens were immersed in Indian ink solution for 72 hours after completion of 1500 cycles of thermal cycling. Then demineralized, cleared and evaluated for the deepest length of dye penetration using a stereomicroscope. Specimens were then cut longitudinally and the length of penetration was measured again by the same instrument. The mean difference of the penetrated length was analyzed by two methods using the paired t test and an analysis of correlation (α = 0.05). Results: No significant difference was found in the mean microleakage measured by the two methods (P= 0.07). Significant correlation was found between them (P=0.0001, r= 0.9) Conclusion: The clearing technique and longitudinal sectioning showed the same results in microleakage of Glassix post and composite core within the limitation of the present study. PMID:21998786

  20. Comparison of epidural oxycodone and epidural morphine for post-caesarean section analgesia: A randomised controlled trial.

    PubMed

    Sng, Ban Leong; Kwok, Sarah Carol; Mathur, Deepak; Ithnin, Farida; Newton-Dunn, Clare; Assam, Pryseley Nkouibert; Sultana, Rehena; Sia, Alex Tiong Heng

    2016-03-01

    Epidural morphine after caesarean section may cause moderate to severe pruritus in women. Epidural oxycodone has been shown in non-obstetric trials to reduce pruritus when compared to morphine. We hypothesised that epidural oxycodone may reduce pruritus after caesarean section. A randomised controlled trial was conducted in pregnant women at term who underwent caesarean section with combined spinal-epidural technique initiated with intrathecal fentanyl 15 μg. Women received either epidural morphine 3 mg or epidural oxycodone 3 mg via the epidural catheter after delivery. The primary outcome was the incidence of pruritus at 24 h after caesarean section. The secondary outcomes were the pruritus scores, treatment for post-operative nausea and vomiting (PONV), pain scores and maternal satisfaction. One hundred women were randomised (group oxycodone O = 50, morphine M = 50). There was no difference between Group O and M in the incidence of pruritus (n [%] 28 [56%] vs. 31 [62%], P = 0.68) and the worst pruritus scores (mean [standard deviation] 2.6 (2.8) vs. 3.3 [3.1], P = 0.23), respectively. Both groups had similar pain scores at rest (2.7 [2.3] vs. 2.0 [2.7], P = 0.16) and sitting up (5.0 [2.3] vs. 4.6 [2.4], P = 0.38) at 24 h. Pruritus scores were lower at 4-8, 8-12 and 12-24 h with oxycodone, but pain scores were higher. Both groups had a similar need for treatment of PONV and maternal satisfaction with analgesia. There was no difference in the incidence of pruritus at 24 h between epidural oxycodone and morphine. However, pruritus scores were lower with oxycodone between 4 and 24 h after surgery with higher pain scores in the same period.

  1. Comparison of epidural oxycodone and epidural morphine for post-caesarean section analgesia: A randomised controlled trial

    PubMed Central

    Sng, Ban Leong; Kwok, Sarah Carol; Mathur, Deepak; Ithnin, Farida; Newton-Dunn, Clare; Assam, Pryseley Nkouibert; Sultana, Rehena; Sia, Alex Tiong Heng

    2016-01-01

    Background and Aims: Epidural morphine after caesarean section may cause moderate to severe pruritus in women. Epidural oxycodone has been shown in non-obstetric trials to reduce pruritus when compared to morphine. We hypothesised that epidural oxycodone may reduce pruritus after caesarean section. Methods: A randomised controlled trial was conducted in pregnant women at term who underwent caesarean section with combined spinal-epidural technique initiated with intrathecal fentanyl 15 μg. Women received either epidural morphine 3 mg or epidural oxycodone 3 mg via the epidural catheter after delivery. The primary outcome was the incidence of pruritus at 24 h after caesarean section. The secondary outcomes were the pruritus scores, treatment for post-operative nausea and vomiting (PONV), pain scores and maternal satisfaction. Results: One hundred women were randomised (group oxycodone O = 50, morphine M = 50). There was no difference between Group O and M in the incidence of pruritus (n [%] 28 [56%] vs. 31 [62%], P = 0.68) and the worst pruritus scores (mean [standard deviation] 2.6 (2.8) vs. 3.3 [3.1], P = 0.23), respectively. Both groups had similar pain scores at rest (2.7 [2.3] vs. 2.0 [2.7], P = 0.16) and sitting up (5.0 [2.3] vs. 4.6 [2.4], P = 0.38) at 24 h. Pruritus scores were lower at 4–8, 8–12 and 12–24 h with oxycodone, but pain scores were higher. Both groups had a similar need for treatment of PONV and maternal satisfaction with analgesia. Conclusion: There was no difference in the incidence of pruritus at 24 h between epidural oxycodone and morphine. However, pruritus scores were lower with oxycodone between 4 and 24 h after surgery with higher pain scores in the same period. PMID:27053782

  2. Use of range vernier data in missile post-flight accuracy evaluation

    NASA Astrophysics Data System (ADS)

    Shipplett, C. M.

    Rockwell conducts accuracy evaluations for the Ogden Air Logistics Center for selected Minuteman Operational Test flights. As a part of these evaluations, regression analysis are performed with guidance-minus-radar slant range comparisons as observables. Typically there are six or seven radars tracking the post-boost vehicle which carries a coherent C-band transponder. Several of these radars also provide range rate data. For a recent Minuteman III test flight, an experimental range vernier tape generated by Federal Electric Corporation was supplied to Rockwell. This tape contained data from one site only, and was used in conjunction with the standard assortment of radar tapes in the post-flight evaluation. This paper describes and shows examples of the effects of using range vernier data.

  3. Use of band-pass filter analysis to evaluate outcomes in an antidepressant trial for treatment resistant patients.

    PubMed

    Targum, Steven D; Burch, Daniel J; Asgharnejad, Mahnaz; Petersen, Timothy; Gomeni, Roberto; Fava, Maurizio

    2014-08-01

    Band-pass filtering is a novel statistical methodology that proposes that filtering out data from trial sites generating non-plausible high or low levels of placebo response can yield a more accurate effect size and greater separation of active drug (when efficacious) from placebo. We applied band-pass filters to re-analyze data from a negative antidepressant trial (NCT00739908) evaluating CX157 (a reversible and selective monoamine oxidase inhibitor-A) versus placebo. 360 patients from 29 trial sites were randomized to either CX157 treatment (n=182) or placebo (n=178). We applied two filters of<3 or>7 points (filter #1) or<3 and>9 points (filter #2) mean change of the total MADRS placebo scores for each site. Trial sites that had mean placebo MADRS score changes exceeding the boundaries of these band-pass filter thresholds were considered non-informative and all of the data from these sites were excluded from the post-hoc re-analysis. The two band-pass filters reduced the sample of informative patients from 353 patients in the mITT population to 62 in filter #1 and 152 in the filter #2 group. The placebo response was reduced from 31.1% in the mITT population to 9.4% with filter #1 and 20.8% with filter #2. MMRM analysis revealed a non-statistically significant trend of p=0.13 and 0.16 for the two filters in contrast to the mITT population (p= 0.58). Our findings support the band-pass filter hypothesis and highlight issues related to site-based scoring variability and inappropriate subject selection that may contribute to trial failure.

  4. In silico imaging clinical trials for regulatory evaluation: initial considerations for VICTRE, a demonstration study

    NASA Astrophysics Data System (ADS)

    Badano, Aldo; Badal, Andreu; Glick, Stephen; Graff, Christian G.; Samuelson, Frank; Sharma, Diksha; Zeng, Rongping

    2017-03-01

    Expensive and lengthy clinical trials can delay regulatory evaluation and add significant burden that stifles innovation affecting patient access to novel, high-quality imaging technologies. In silico imaging holds promise for evaluating the safety and effectiveness of imaging technologies with much less burden than clinical trials. We define in silico imaging as a computer simulation of an entire imaging system (including source, object, task, and observer components) used for research, development, optimization, technology assessment, and regulatory evaluation of new technology. In this work we describe VICTRE (our study of virtual imaging clinical trials for regulatory evaluation) and the considerations for building an entire imaging pipeline in silico including device (physics), patient (anatomy, disease), and image interpretation models for regulatory evaluation using open-source tools.

  5. Designing and evaluating the effectiveness of a serious game for safe administration of blood transfusion: A randomized controlled trial.

    PubMed

    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 (p<0.001) after the serious game intervention compared to pre-test mean scores and to post-test mean scores of the control group (p<0.001). However, no significance difference (p=0.11) was found between the experimental and control groups on the post-test performance mean scores. The participants evaluated the serious game 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

  6. Evaluation of selection criteria used in Alzheimer's disease clinical trials.

    PubMed

    Willmer, J; Mohr, E

    1998-02-01

    In the absence of a biological marker for Alzheimer's disease (AD), diagnosis has to be achieved using clinical criteria sets such as those outlined in DSM-IV, NINCDS-ADRDA, or ICD-10. As these criteria are quite broadly defined, there may be inter-rater variability in interpretation. Using a previously published CT scan measuring technique which correlates well with diagnoses achieved using the NINCDS-ADRDA criteria as interpreted at our clinic, we chose to independently examine and reach a diagnosis in patients selected for participation in clinical trials of therapeutic agents for the treatment of AD. Forty-four CT scans from six investigators across Canada were examined using this model. All patients had been diagnosed as having AD by NINCDS-ADRDA criteria and were deemed acceptable to participate in a clinical trial. The diagnostic concordance achieved in the original published model was 91.5%. The diagnostic concordance in the population currently being studied was 77.3%. However when examined by site, results ranged from 57.1% to 100%. Using the model, an index of atrophy and a probability of diagnosis of AD can be determined. Across sites, there were statistically significant differences in these measures (p < or = 0.035). The mean probability of diagnosis of AD across sites ranged from 0.56 to 0.94. Although the sites with lower probabilities had slightly lower mean ages and slightly less atrophy, there was no overall correlation of the atrophy measures with age. Current results raise the possibility that the selection of patients for AD clinical trials using current diagnostic criteria sets may not be adequate and conclusions with respect to agent efficacy could be flawed.

  7. Impact of intercostal paravertebral neurectomy on post thoracotomy pain syndrome after thoracotomy in lung cancer patients: a randomized controlled trial

    PubMed Central

    Althaus, Astrid; Poels, Marcel; Joppich, Robin; Lefering, Rolf; Wappler, Frank; Windisch, Wolfram; Ludwig, Corinna; Stoelben, Erich

    2016-01-01

    Background Thoracotomy leads to chronic neuropathic pain in up to 50% of patients and is responsible for an impaired quality of life. Intercostal nerve injury has been suggested to be responsible for this pain. In the present study the impact of paravertebral intercostal neurectomy on post thoracotomy pain was assessed. Methods In this single center parallel-group randomized controlled trial patients underwent muscle sparing anterolateral thoracotomy and anatomical lung resection for lung cancer. A subcostal approach was used for thoracotomy with single paravertebral neurectomy being performed at the beginning of the procedure at the level of the retracted intercostal space. For documentation of neuropathic pain the Leeds Assessment Score for Neuropathic Symptoms and Signs (LANSS) was used postoperatively. The primary endpoint was defined as LANSS ≥12 points on day 120. In addition, the numeric pain rating scale (NRS) was used to score pain intensity. Results Out of 172 patients initially randomized 161 patients were investigated following intraoperative and postoperative drop-out criteria. All patients required anatomical lung resection via thoracotomy. Five patients were lost for follow up. For the remaining 156 patients there was no difference between the two groups with regard to LANSS ≥12: 26.6% in patients with neurectomy and 28.8% in control-subjects (P=0.78). In addition, the NSR score at day 120 did not differ significantly at rest and during activity between the two groups (at rest: 21.7% vs. 15.8% P=0.439; activity: 24.5% vs. 21.9% P=0.735). Conclusions Neurectomy was not shown to reduce the post thoracotomy pain syndrome in patients with anatomical lung resection following anterolateral muscle sparing thoracotomy. PMID:27746994

  8. Evaluation of a general practice registrar training post in public health in rural New South Wales.

    PubMed

    Fraser, John

    2002-07-01

    General practitioners have an expanding public health role in Australia. Improved training is recommended to optimise this involvement. An advanced post for GP registrars in population health was piloted in rural New South Wales. A reference group with experience in general practice and public health education advised on the development of the post, curriculum and qualitative evaluation framework. A part time GP registrar was employed within the local Division of General Practice and Public health unit. Effective collaboration between stakeholders promoted teaching, research and practice in population health within a rural area. The registrar developed skills in project design, data analysis and report writing during this training post. This pilot demonstrates the feasibility of public health training for a GP registrar within a rural area. Projects in health promotion benefited from the input of a GP registrar among other stakeholders.

  9. A feasibility randomised controlled trial of acupressure to assist spontaneous labour for primigravid women experiencing a post-date pregnancy.

    PubMed

    Mollart, Lyndall; Skinner, Virginia; Foureur, Maralyn

    2016-05-01

    this Australian feasibility study aimed to determine; the willingness of women experiencing a post-date pregnancy to participate in a randomised controlled trial (RCT) of acupressure and compliance with the study protocol. The study also aimed to determine the effect size of the primary outcome in order to calculate a sample size for a future appropriately powered RCT. a two-arm randomised controlled trial. Staff providing clinical care were blinded to group allocation unless the participant disclosed study participation. maternity services at two outer metropolitan public hospitals in New South Wales, Australia sixty seven healthy primigravid women experiencing a singleton cephalic pregnancy at 40 weeks±2 days gestation were assessed as eligible to participate and were provided with study information. both groups received standard clinical care, with the intervention group also receiving verbal and written instructions on the self-administration of three acupoints (Spleen 6, Large Intestine 4, and Gall Bladder 21) to be used until spontaneous or induced labour began. assessment of feasibility included determining recruitment rate and acceptability of an RCT for a CAM modality, and acupressure treatment compliance, via participant surveys. The primary clinical outcome was spontaneous onset of labour. from the 67 women eligible during the timeframe for the study, 44 women (65.6%) agreed to participate and were randomised. There was no statistically significant difference in rate of spontaneous onset of labour (50% acupressure vs 41% control). Twenty nine participant surveys were returned (65.9%). In the intervention group there was a high compliance with the acupressure protocol (83%) and the use of the three acupoints (94%). this feasibility study revealed that pregnant women are interested in the use of CAM, and acupressure in particular, for the initiation of labour. Most women found it acceptable to be randomised to receive the intervention. While the 9

  10. Descriptive analysis of a 1:1 physiotherapy outpatient intervention post primary lumbar discectomy: one arm of a small-scale parallel randomised controlled trial across two UK sites

    PubMed Central

    Rushton, A; Calcutt, A; Heneghan, N; Heap, A; White, L; Goodwin, P

    2016-01-01

    Objective There is a lack of high-quality evidence for physiotherapy post lumbar discectomy. Substantial heterogeneity in treatment effects may be explained by variation in quality, administration and components of interventions. An optimised physiotherapy intervention may reduce heterogeneity and improve patient benefit. The objective was to describe, analyse and evaluate an optimised 1:1 physiotherapy outpatient intervention for patients following primary lumbar discectomy, to provide preliminary insights. Design A descriptive analysis of the intervention embedded within an external pilot and feasibility trial. Setting Two UK spinal centres. Participants Participants aged ≥18; post primary, single level, lumbar discectomy were recruited. Intervention The intervention encompassed education, advice, mobility and core stability exercises, progressive exercise, and encouragement of early return to work/activity. Patients received ≤8 sessions for ≤8 weeks, starting 4 weeks post surgery (baseline). Outcomes Blinded outcome assessment at baseline and 12 weeks (post intervention) included the Roland Morris Disability Questionnaire. STarT Back data were collected at baseline. Statistical analyses summarised participant characteristics and preplanned descriptive analyses. Thematic analysis grouped related data. Findings Twenty-two of 29 allocated participants received the intervention. STarT Back categorised n=16 (55%) participants ‘not at low risk’. Physiotherapists identified reasons for caution for 8 (36%) participants, commonly risk of overdoing activity (n=4, 18%). There was no relationship between STarT Back and physiotherapists’ evaluation of caution. Physiotherapists identified 154 problems (mean (SD) 5.36 (2.63)). Those ‘not at low risk’, and/or requiring caution presented with more problems, and required more sessions (mean (SD) 3.14 (1.16)). Conclusions Patients present differently and therefore require tailored interventions. These

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

    NASA Astrophysics Data System (ADS)

    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.

  12. Is there a need for cervical collar usage post anterior cervical decompression and fusion using interbody cages? A randomized controlled pilot trial.

    PubMed

    Abbott, Allan; Halvorsen, Marie; Dedering, Asa

    2013-05-01

    Anterior cervical discectomy and fusion (ACDF) is a common surgical intervention for radiculopathy resulting from degenerative cervical spine conditions. Post-surgical cervical collar use is believed to reduce post-operative pain, provide the patient with a sense of security during activities of daily living and even reduce rates of non-fusion. This prospective randomized controlled pilot trial investigates trial design feasibility in relation to prospective physical, functional, and quality of life-related outcomes of patients undergoing ACDF with interbody cage, with (n = 17) and without (n = 16) post-operative cervical collar usage. Results show that the sample provides sufficient statistical power to show that the use of a rigid cervical collar during 6 post-operative weeks is associated with significantly lower levels of neck disability index after 6 weeks and significantly lower levels of prospective neck pain. To investigate causal quality of life or fusion rate outcomes, sample size needs to be increased at least fourfold and optimally sixfold when accounting for data loss in prospective follow-up. The study suggests that post-surgical cervical collar usage may help certain patients cope with initial post-operative pain and disability.

  13. A systematic review evaluating the impact of post-registration nursing and midwifery education on practice.

    PubMed

    Gijbels, Harry; O'Connell, Rhona; Dalton-O'Connor, Caroline; O'Donovan, Moira

    2010-03-01

    Given the current focus on evidence-based practice, it is surprising that there is a dearth of systematic evidence of the impact on practice of post-registration nursing and midwifery education. The systematic review presented here formed part of a national review of post-registration nursing and midwifery education in Ireland [Health Service Executive, 2008. Report of the Post-registration Nursing and Midwifery Education Review Group: Changing practice to support service delivery. Health Service Executive, Dublin]. The review focuses specifically on the impact on practice from the perspective of nurses, midwives, patients, carers, education and health service providers. Sixty-one (61) studies met the criteria set. These studies were mainly of a retrospective and descriptive nature, often with small cohorts, set within one educational setting. The findings indicate that students benefit from post-registration programmes in relation to changes in attitudes, perceptions, knowledge and in skill acquisition. There is also some evidence that students apply their newly acquired attitudes, knowledge and skills. There is however limited evidence of the direct impact on organisational and service delivery changes, and on benefits to patients and carers. It can be concluded that the impact of post-registration nursing and midwifery education on practice has yet to be fully explored through a more systematic and coherent programme evaluation approach.

  14. A Value-Theoretic Expert System for Evaluating Randomized Clinical Trials

    PubMed Central

    Klein, David A.; Lehmann, Harold P.; Shortliffe, Edward H.

    1990-01-01

    Multiattribute Value Theory (MVT) provides a formal approach to evaluating populations of similar alternatives. In this paper, we illustrate the employment of MVT in the context of medical expert systems by describing RCTE, a prototype application for performing comparative analyses of randomized clinical trials (RCTs). RCTE employs MVT to evaluate RCTs and implements techniques from Interpretive Value Analysis to explain such evaluations automatically. Although experimental, our approach suggests that MVT provides a basis for evaluating similar alternatives in selected medical expert systems.

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

    PubMed

    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

  16. Headache relief after anterior cervical discectomy: post hoc analysis of a randomized investigational device exemption trial: clinical article.

    PubMed

    Schrot, Rudolph J; Mathew, Jesna S; Li, Yueju; Beckett, Laurel; Bae, Hyun W; Kim, Kee D

    2014-08-01

    The authors analyzed headache relief after anterior cervical discectomy. Headache may be relieved after anterior cervical discectomy, but the mechanism is unknown. If headaches were directly referred from upper cervical pathology, more headache relief would be expected from surgery performed at higher cervical levels. If spinal kinesthetics were the mechanism, then headache relief may differ between arthroplasty and fusion. Headache relief after anterior cervical discectomy was quantified by the operated disc level and by the method of operation (arthroplasty vs arthrodesis). The authors performed a post hoc analysis of an artificial disc trial. Data on headache pain were extracted from the Neck Disability Index (NDI) questionnaire. A total of 260 patients underwent single-level arthroplasty or arthodesis. Preoperatively, 52% reported NDI headache scores of 3 or greater, compared with only 13%-17% postoperatively. The model-based mean NDI headache score at baseline was 2.5 (95% CI 2.3-2.7) and was reduced by 1.3 points after surgery (95% CI 1.2-1.4, p < 0.001). Higher cervical levels were associated with a greater degree of preoperative headache, but there was no association with headache relief. There was no significant difference in headache relief between arthroplasty and arthrodesis. Most patients with symptomatic cervical spondylosis have headache as a preoperative symptom (88%). Anterior cervical discectomy with both arthroplasty and arthrodesis is associated with a durable decrease in headache. Headache relief is not related to the level of operation. The mechanism for headache reduction remains unclear.

  17. Massage as adjuvant therapy in the management of post-cesarean pain and anxiety: A randomized clinical trial.

    PubMed

    Saatsaz, Sussan; Rezaei, Rozita; Alipour, Abbas; Beheshti, Zahra

    2016-08-01

    The present study was conducted to determine the effect of massage on post-cesarean pain and anxiety. The present single-blind clinical trial was conducted on 156 primiparous women undergone elective cesarean section. The participants were randomly divided into three groups, including a hand and foot massage group, a foot massage group and a control group (n = 52 per group). The patients' intensity of pain, vital signs and anxiety level were measured before, immediately after and 90 min after the massage. A significant reduction was observed in the intensity of pain immediately and 90 min after massage (P < 0.001). Moreover, changes in some of the physiological parameters, including blood pressure and respiration rate, were significant after massage (P < 0.001); however, this change was not significant for pulse rate. A significant reduction was also observed in the level of anxiety (P < 0.001) and a significant increase in the frequency of breastfeeding (P < 0.001) after massage. As an effective nursing intervention presenting no side-effects, hand and foot massage can be helpful in the management of postoperative pain and stress. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance.

    PubMed

    Langley, Richard G B; Luger, Thomas A; Cork, Michael J; Schneider, Dirk; Paul, Carle

    2007-01-01

    In this report, we review the data on the safety and tolerability of pimecrolimus cream 1% (Elidel) from clinical trials and post-marketing surveillance in patients with atopic dermatitis. These data demonstrate that topically applied pimecrolimus is minimally absorbed through the skin and has a favourable safety margin. The most common treatment-related adverse events are transient local reactions, particularly skin burning (16.1 and 12.9 events per 1,000 patient-months of follow-up in adults and children, respectively). When compared to the vehicle, the use of pimecrolimus cream 1% is associated with an increased incidence of herpes simplex virus infections in children (relative risk: 2.5; 95% confidence interval: 1.2-5.8; p = 0.017). However, pimecrolimus cream 1% does not increase the incidence of any skin infection in comparison with moderately potent topical corticosteroids and lacks other corticosteroid-related side effects such as skin atrophy. While cases of malignancy have been reported in patients who have used pimecrolimus cream 1%, there is no clinical evidence to establish that treatment with pimecrolimus cream 1% increases the risk of malignancy. Copyright 2007 S. Karger AG, Basel.

  19. The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent.

    PubMed

    Egekeze, Nkemakolam; Dubin, Jonathan; Williams, Karen; Bernhardt, Mark

    2016-10-05

    Integral to an orthopaedic surgeon-patient informed consent discussion is the assessment of patient comprehension of their medical care. However, little is known about how to optimize patient comprehension of an informed consent discussion. The purpose of our study was to evaluate three time-controlled informed consent discussion methods to determine which optimized patient comprehension immediately after the discussion. Sixty-seven consecutive patients with knee osteoarthritis who were considered medically appropriate for a knee corticosteroid injection were enrolled in our trial. Participants were randomized and were allocated into one of three groups in a parallel fashion and 1:1:1 ratio. Our three groups varied by sensory input and included verbal (hearing), verbal and video (hearing and sight), and verbal and model (hearing, sight, and touch). Each participant listened to a 10-minute scripted lecture given by a researcher; this lecture was based on content from the American Academy of Orthopaedic Surgeons patient education web site OrthoInfo. Patient comprehension was assessed after the lecture using a validated questionnaire called the Nkem test. Our primary outcome evaluated patient comprehension utilizing a pairwise comparison of mean comprehension scores between the groups. The primary outcome was analyzed using a one-way analysis of variance with the least significant difference calculated post hoc and a 95% confidence interval (95% CI). The health-care staff, study participants, and outcome assessor were each blinded to group assignments. The mean comprehension scores were 84% (95% CI, 79% to 88%) for the verbal and model group, 74% (95% CI, 63% to 80%) for the verbal and video group, and 71% (95% CI, 61% to 80%) for the verbal group. The omnibus analysis of variance was significant and showed a difference among the groups (p = 0.019). The pairwise comparison of the groups using the least significant difference calculated post hoc showed that the verbal

  20. Erythropoietin in patients with traumatic brain injury and extracranial injury-A post hoc analysis of the erythropoietin traumatic brain injury trial.

    PubMed

    Skrifvars, Markus B; Bailey, Michael; French, Craig; Presneill, Jeffrey; Nichol, Alistair; Little, Lorraine; Duranteau, Jacques; Huet, Olivier; Haddad, Samir; Arabi, Yaseen; McArthur, Colin; Cooper, D James; Bellomo, Rinaldo

    2017-09-01

    Erythropoietin (EPO) may reduce mortality after traumatic brain injury (TBI). Secondary brain injury is exacerbated by multiple trauma, and possibly modifiable by EPO. We hypothesized that EPO decreases mortality more in TBI patients with multiple trauma, than in patients with TBI alone. A post hoc analysis of the EPO-TBI randomized controlled trial conducted in 2009 to 2014. To evaluate the impact of injuries outside the brain, we calculated an extracranial Injury Severity Score (ISS) that included the same components of the ISS, excluding head and face components. We defined multiple trauma as two injured body regions with an Abbreviated Injury Scale (AIS) score of 3 or higher. Cox regression analyses, allowing for potential differential responses per the presence or absence of extracranial injury defined by these injury scores, were used to assess the effect of EPO on time to mortality. Of 603 included patients, the median extracranial ISS was 6 (interquartile range, 1-13) and 258 (43%) had an AIS score of 3 or higher in at least two body regions. On Cox regression, EPO was associated with decreased mortality in patients with greater extracranial ISS (interaction p = 0.048) and weakly associated with differential mortality with multiple trauma (AIS score > 3 or in two regions, interaction p = 0.17). At 6 months in patients with extracranial ISS higher than 6, 10 (6.8%) of 147 EPO-treated patients compared with 26 (17%) of 154 placebo-treated patients died (risk reduction, 10%; 95% confidence interval, 2.9-17%; p = 0.007). In this post hoc analysis, EPO administration was associated with a potential differential improvement in 6-month mortality in TBI patients with more severe extracranial injury. These findings need confirmation in future clinical and experimental studies. Therapeutic study, level III.

  1. Bonding effectiveness of two adhesive luting cements to glass fiber posts: pull-out evaluation of three different post surface conditioning methods.

    PubMed

    Graiff, Lorenzo; Rasera, Laura; Calabrese, Marco; Vigolo, Paolo

    2014-01-01

    The purpose of this study was to evaluate the bond strength at the post/resin-cement interface with 3 different surface treatments of glass fiber posts and with 2 different luting resin cements. Sixty glass fiber posts (RelyX Fiber Post) were randomly divided into 3 groups (n = 20) and were luted with a dual-polymerizing self-adhesive universal resin cement (RelyX Unicem) and with a dual-polymerizing resin cement (RelyX ARC). This was carried out in association with a dual-polymerizing adhesive (Scotchbond Multi-Purpose Plus) in simulated plexiglass root canals after receiving three different pretreatment procedures. A pull-out test was performed on each sample to measure bond strengths. Data were analyzed with two-way ANOVA. Two samples from each group were processed for SEM observations in order to investigate the morphologic aspect of the post/cement interface. Both resin cements demonstrated significant different bond strength values (P < 0.0001). The surface treatment result was also statistically significant (P = 0.0465). SEM examination showed a modification of the post surface after pretreatment with methyl methacrylate. The dual-polymerizing self-adhesive universal resin cement achieved higher MPa bond strength values. The use of methyl methacrylate as a surface treatment of glass fiber posts provided a significant increase in bond strengths between the posts and both luting materials.

  2. Bonding Effectiveness of Two Adhesive Luting Cements to Glass Fiber Posts: Pull-Out Evaluation of Three Different Post Surface Conditioning Methods

    PubMed Central

    Calabrese, Marco

    2014-01-01

    The purpose of this study was to evaluate the bond strength at the post/resin-cement interface with 3 different surface treatments of glass fiber posts and with 2 different luting resin cements. Sixty glass fiber posts (RelyX Fiber Post) were randomly divided into 3 groups (n = 20) and were luted with a dual-polymerizing self-adhesive universal resin cement (RelyX Unicem) and with a dual-polymerizing resin cement (RelyX ARC). This was carried out in association with a dual-polymerizing adhesive (Scotchbond Multi-Purpose Plus) in simulated plexiglass root canals after receiving three different pretreatment procedures. A pull-out test was performed on each sample to measure bond strengths. Data were analyzed with two-way ANOVA. Two samples from each group were processed for SEM observations in order to investigate the morphologic aspect of the post/cement interface. Both resin cements demonstrated significant different bond strength values (P < 0.0001). The surface treatment result was also statistically significant (P = 0.0465). SEM examination showed a modification of the post surface after pretreatment with methyl methacrylate. The dual-polymerizing self-adhesive universal resin cement achieved higher MPa bond strength values. The use of methyl methacrylate as a surface treatment of glass fiber posts provided a significant increase in bond strengths between the posts and both luting materials. PMID:24987418

  3. Theory-Driven Process Evaluation of a Complementary Feeding Trial in Four Countries

    ERIC Educational Resources Information Center

    Newman, Jamie E.; Garces, Ana; Mazariegos, Manolo; Hambidge, K. Michael; Manasyan, Albert; Tshefu, Antoinette; Lokangaka, Adrien; Sami, Neelofar; Carlo, Waldemar A.; Bose, Carl L.; Pasha, Omrana; Goco, Norman; Chomba, Elwyn; Goldenberg, Robert L.; Wright, Linda L.; Koso-Thomas, Marion; Krebs, Nancy F.

    2014-01-01

    We conducted a theory-driven process evaluation of a cluster randomized controlled trial comparing two types of complementary feeding (meat versus fortified cereal) on infant growth in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo. We examined process evaluation indicators for the entire study cohort (N = 1236) using chi-square…

  4. Theory-Driven Process Evaluation of a Complementary Feeding Trial in Four Countries

    ERIC Educational Resources Information Center

    Newman, Jamie E.; Garces, Ana; Mazariegos, Manolo; Hambidge, K. Michael; Manasyan, Albert; Tshefu, Antoinette; Lokangaka, Adrien; Sami, Neelofar; Carlo, Waldemar A.; Bose, Carl L.; Pasha, Omrana; Goco, Norman; Chomba, Elwyn; Goldenberg, Robert L.; Wright, Linda L.; Koso-Thomas, Marion; Krebs, Nancy F.

    2014-01-01

    We conducted a theory-driven process evaluation of a cluster randomized controlled trial comparing two types of complementary feeding (meat versus fortified cereal) on infant growth in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo. We examined process evaluation indicators for the entire study cohort (N = 1236) using chi-square…

  5. The immediate impact of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial on the management of stable angina.

    PubMed

    Atwater, Brett D; Oujiri, James; Wolff, Matthew R

    2009-08-01

    The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial confirmed that percutaneous coronary intervention is no better than optimal medical therapy for the prevention of major adverse cardiac events in patients with stable angina. The impact of these findings on clinical practice remains unknown. Clinicians may more frequently opt for medical rather than procedural therapy of stable angina in response to the COURAGE trial. Clinical information was collected from patients with stable angina referred to our hospital for cardiac catheterization between January 1, 2007 and June 18, 2007 (n = 332). Catheterization referral volume and the use of medications and coronary revascularization were compared before and after the release of the COURAGE trial. There was a significant increase in anti-ischemia medication use prior to catheterization referral following the COURAGE trial (mean = 1.31 [SD 0.83] medications pre-COURAGE, mean = 1.54 [SD 0.84] medications post-COURAGE, P = 0.012). Among 217 patients with coronary disease on catheterization, treatment with medication rather than percutaneous or surgical revascularization increased after COURAGE (11.1% pre-COURAGE vs 23.0% post-COURAGE, P = 0.03). There was also a significant decrease in referral volume following the COURAGE trial (3.12 referrals/day pre-COURAGE vs 2.51 referrals/day post-COURAGE, P = 0.034). The COURAGE trial immediately impacted the management of stable angina. Catheterization referral volume decreased, medication use increased, and the use of medical therapy rather than revascularization increased among patients with coronary disease.

  6. Evaluation of Low Level Laser Therapy on Pain Perception Following Orthodontic Elastomeric Separation: A Randomized Controlled Trial

    PubMed Central

    Almallah, Mai M.E.; Almahdi, Wael H.

    2016-01-01

    Introduction Periodontal pain caused by elastomeric separators is a very common problem in the commencement of orthodontic treatment. Previous studies have shown good results in reducing this pain by Low Level Laser Therapy (LLLT) and different protocols of application have been suggested in the literature. Aim This trial aimed to evaluate LLLT on managing orthodontic pain caused by elastomeric separators and to compare single versus double irradiation in possible pain reduction. Materials and Methods A clinical randomized compound (parallel-group and split-mouth design) trial was conducted on 36 patients between 12 and 26 years of age. Elastomeric separators were placed at the mesial and distal surfaces of the first molars in one jaw (upper or lower) for each patient and in only one side of the mouth (the other side served as the placebo side). The trial had two groups: the first group received single irradiation of LLLT [Gallium Aluminum Arsenide (GaAlAs): 830 nm, 4J/cm2, 100mW] immediately after separators insertion, where as the second group received double irradiation immediately after separators insertion and after 24hours. All patients were instructed to rate the level of pain at 1, 6, 24, 48, 96 hours on a Visual Analog Scale (VAS). The student ‘t’ tests, repeated measures ANOVA and LSD post-hoc tests were employed. Results LLLT was successful in reducing post-separation pain when the experimental side was compared to the placebo side at all assessment times in each group (p<0.05). There were no statistically significant differences between single and double irradiation groups in terms of pain reduction (p>0.05). Conclusion GaAlAs LLLT application reduced early orthodontic pain caused by elastomeric separators by single or double irradiation. PMID:28050498

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

    PubMed

    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 melat