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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. Evaluation of Post Cessation Weight Gain in a 1-Year Randomized Smoking Cessation Trial of Electronic Cigarettes

    PubMed Central

    Russo, Cristina; Cibella, Fabio; Caponnetto, Pasquale; Campagna, Davide; Maglia, Marilena; Frazzetto, Evelise; Mondati, Enrico; Caruso, Massimo; Polosa, Riccardo

    2016-01-01

    Stop smoking it is often associated to weight gain that is one of the most important causes for relapse. This is the first study to describe long-term changes in body weight in smokers invited to quit or reduce smoking by switching to ECs. Conventional cigarettes consumption and body weight were measured prospectively in a randomized controlled trial of smokers invited to switch to ECs. Post cessation weight changes from baseline at week-12, -24 and -52 were compared among 1) high, medium and zero nicotine strength products and 2) pooled continuous smoking failure, smoking reduction and abstinence phenotypes. Saliva cotinine levels and appetite levels were also measured. No significant changes in body weight were observed among high, medium and zero nicotine strength products. Differences among continuous smoking phenotypes were significant only at week-12 (p = 0.010) and week-24 (p = 0.012) with quitters gaining 2.4{plus minus}4.3 Kg and 2.9{plus minus}4.4 Kg respectively. However, weight gain at week-52 (1.5{plus minus}5.0 Kg) was no longer significant compared to Failures and Reducers. No confounding factors could explain the significant changes in body weight. Smokers who quit smoking by switching to ECs may limit their post-cessation weight gain, with substantial reversal in weight gain being manifest at late time points. PMID:26729619

  3. 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

  4. 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

  5. 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. PMID:25444788

  6. 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

  7. 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

  8. 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. PMID:23893464

  9. 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

  10. 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. PMID:26193849

  11. 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. PMID:12522699

  12. 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

  13. Pleiotropic effect of lovastatin, with and without cholestyramine, in the post coronary artery bypass graft (Post CABG) trial.

    PubMed

    Domanski, Michael; Tian, Xin; Fleg, Jerome; Coady, Sean; Gosen, Christine; Kirby, Ruth; Sachdev, Vandana; Knatterud, Genell; Braunwald, Eugene

    2008-10-15

    This study evaluated patients in the Post Coronary Artery Bypass Graft (Post CABG) trial for evidence of statin pleiotropic effects in preventing atherosclerotic progression in saphenous vein grafts (SVGs). We studied 1,116 of the 1,351 patients in the Post CABG trial who were randomized to aggressive (low-density lipoprotein [LDL] cholesterol target <85 mg/dl) or moderate (target LDL cholesterol <140 mg/dl) lovastatin treatment and who had sufficient data available. The generalized estimating equation models, adjusting for important covariates, were applied to estimate the odds ratios (ORs) and probability of substantial atherosclerotic SVG progression (decrease in lumen diameter >or=0.6 mm) and the difference in minimum lumen diameter change between treatment groups. Aggressive lovastatin treatment compared with moderate treatment was associated with a significant decrease in risk of significant SVG atherosclerotic progression after adjustment for baseline cholesterol level, LDL cholesterol on treatment, high-density lipoprotein cholesterol, and triglyceride changes on treatment and other independent predictors (OR 0.68, 95% confidence interval 0.49 to 0.94, p = 0.019). Results were similar when the change or percent change from baseline of LDL cholesterol level on treatment was adjusted for rather than on-treatment LDL cholesterol and in the subset achieving a year-1 LDL cholesterol level from 90 to 135 mg/dl (OR 0.64, 95% confidence interval 0.42 to 0.98, p = 0.042). Mean decrease in minimum lumen diameter was also significantly smaller in the aggressive than the moderate treatment arm (-0.256 vs -0.343 mm, p = 0.042). In conclusion, aggressive versus moderate lovastatin treatment appeared therapeutic in slowing the atherosclerotic process in SVGs from Post CABG patients, independent of its greater LDL cholesterol-lowering effect. PMID:18929703

  14. 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. PMID:26481322

  15. 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

  16. 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

  17. 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

  18. Evaluation of a one week intradermal regimen for rabies post-exposure prophylaxis: results of a randomized, open label, active-controlled trial in healthy adult volunteers in India.

    PubMed

    Sudarshan, Mysore Kalappa; Narayana, Doddabele Hanumanthaiah Ashwath; Madhusudana, Shampur Narayan; Holla, Ramesh; Ashwin, Belludi Yajaman; Gangaboraiah, Bilagumba; Ravish, Haradanahalli S

    2012-08-01

    The currently recommended intradermal regimen for post-exposure prophylaxis spreads over a month period which many times lead to low compliance from the patients. There is a need to introduce and evaluate short course regimens to overcome this problem. This study was conducted to evaluate the immunogenicity and safety of a "new one week intradermal regimen" for rabies post-exposure prophylaxis. A total of 80 healthy adult volunteers were enrolled and allocated randomly either to purified chick embryo cell (PCECV) rabies vaccine or purified verocell rabies vaccine (PVRV), 40 in each group. Each subject received intradermally one of the vaccines , using the one week regimen (4-4-4). Blood samples were collected on Days 0, 7, 14, 28,180 and 365 for estimation of rabies virus neutralizing antibody (RVNA) concentration. The sera samples were analyzed by rapid fluorescent focus inhibition test (RFFIT). All subjects in both the groups had adequate RVNA concentration of  0.5 IU/mL from day 14 to till day 180 and the difference of geometric mean concentrations between the two groups was not significant (P > 0.606). Further to assess the immunological memory produced by this new regimen, a "single visit four site" intradermal booster vaccination was given to those who did not have adequate RVNA concentration on day 365. This resulted in a quick and enhanced RVNA concentration in these subjects thus denoting a successful anamnestic response. The incidence of adverse events was 8.3% in PCECV group and 1.6% in PVRV group (P=0.001) and the regimen was well tolerated without any dropouts. In conclusion, the new "one week intradermal regimen" is immunogenic and safe for rabies post-exposure prophylaxis and needs to be further evaluated in persons exposed to rabies. PMID:22699446

  19. Treatment trials for post-Lyme disease symptoms revisited.

    PubMed

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

    2013-08-01

    The authors of 4 National Institutes of Health-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. Two groups recently 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. On the basis of 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

  20. Benefits of post-operative oral protein supplementation in gastrointestinal surgery patients: A systematic review of clinical trials

    PubMed Central

    Crickmer, Mike; Dunne, Colum P; O’Regan, Andrew; Coffey, J Calvin; Dunne, Suzanne S

    2016-01-01

    AIM: To evaluate published trials examining oral post-operative protein supplementation in patients having undergone gastrointestinal surgery and assessment of reported results. METHODS: Database searches (MEDLINE, BIOSIS, EMBASE, Cochrane Trials, Cinahl, and CAB), searches of reference lists of relevant papers, and expert referral were used to identify prospective randomized controlled clinical trials. The following terms were used to locate articles: “oral’’ or “enteral’’ and “postoperative care’’ or “post-surgical’’ and “proteins’’ or “milk proteins’’ or “dietary proteins’’ or “dietary supplements’’ or “nutritional supplements’’. In databases that allowed added limitations, results were limited to clinical trials that studied humans, and publications between 1990 and 2014. Quality of collated studies was evaluated using a qualitative assessment tool and the collective results interpreted. RESULTS: Searches identified 629 papers of which, following review, 7 were deemed eligible for qualitative evaluation. Protein supplementation does not appear to affect mortality but does reduce weight loss, and improve nutritional status. Reduction in grip strength deterioration was observed in a majority of studies, and approximately half of the studies described reduced complication rates. No changes in duration of hospital stay or plasma protein levels were reported. There is evidence to suggest that protein supplementation should be routinely provided post-operatively to this population. However, despite comprehensive searches, clinical trials that varied only the amount of protein provided via oral nutritional supplements (discrete from other nutritional components) were not found. At present, there is some evidence to support routinely prescribed oral nutritional supplements that contain protein for gastrointestinal surgery patients in the immediate post-operative stage. CONCLUSION: The optimal level of protein

  1. Hyperbaric Oxygen Induces Late Neuroplasticity in Post Stroke Patients - Randomized, Prospective Trial

    PubMed Central

    Efrati, Shai; Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Kliakhandler, Kostantin; Kamiager, Izhak; Gal, Nachum; Friedman, Mony; Ben-Jacob, Eshel; Golan, Haim

    2013-01-01

    Background Recovery after stroke correlates with non-active (stunned) brain regions, which may persist for years. The current study aimed to evaluate whether increasing the level of dissolved oxygen by Hyperbaric Oxygen Therapy (HBOT) could activate neuroplasticity in patients with chronic neurologic deficiencies due to stroke. Methods and Findings A prospective, randomized, controlled trial including 74 patients (15 were excluded). All participants suffered a stroke 6–36 months prior to inclusion and had at least one motor dysfunction. After inclusion, patients were randomly assigned to "treated" or "cross" groups. Brain activity was assessed by SPECT imaging; neurologic functions were evaluated by NIHSS, ADL, and life quality. Patients in the treated group were evaluated twice: at baseline and after 40 HBOT sessions. Patients in the cross group were evaluated three times: at baseline, after a 2-month control period of no treatment, and after subsequent 2-months of 40 HBOT sessions. HBOT protocol: Two months of 40 sessions (5 days/week), 90 minutes each, 100% oxygen at 2 ATA. We found that the neurological functions and life quality of all patients in both groups were significantly improved following the HBOT sessions while no improvement was found during the control period of the patients in the cross group. Results of SPECT imaging were well correlated with clinical improvement. Elevated brain activity was detected mostly in regions of live cells (as confirmed by CT) with low activity (based on SPECT) – regions of noticeable discrepancy between anatomy and physiology. Conclusions The results indicate that HBOT can lead to significant neurological improvements in post stroke patients even at chronic late stages. The observed clinical improvements imply that neuroplasticity can still be activated long after damage onset in regions where there is a brain SPECT/CT (anatomy/physiology) mismatch. Trial Registration ClinicalTrials.gov NCT00715897 PMID:23335971

  2. Japanese POEMS syndrome with Thalidomide (J-POST) Trial: study protocol for a phase II/III multicentre, randomised, double-blind, placebo-controlled trial

    PubMed Central

    Katayama, Kanako; Misawa, Sonoko; Sato, Yasunori; Sobue, Gen; Yabe, Ichiro; Watanabe, Osamu; Nishizawa, Masatoyo; Kusunoki, Susumu; Kikuchi, Seiji; Nakashima, Ichiro; Ikeda, Shu-ichi; Kohara, Nobuo; Kanda, Takashi; Kira, Jun-ichi; Hanaoka, Hideki; Kuwabara, Satoshi

    2015-01-01

    Introduction Polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes (POEMS) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor (VEGF). Recently, the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma. However, no randomised clinical trial has been performed because of the rarity and severity of the disease. Methods and analysis The Japanese POEMS syndrome with Thalidomide (J-POST) Trial is a phase II/III multicentre, double-blinded, randomised, controlled trial that aims to evaluate the efficacy and safety of a 24-week treatment with thalidomide in POEMS syndrome, with an additional 48-week open-label safety study. Adults with POEMS syndrome who have no indication for transplantation are assessed for eligibility at 12 tertiary neurology centres in Japan. Patients who satisfy the eligibility criteria are randomised (1:1) to receive thalidomide (100–300 mg daily) plus dexamethasone (12 mg/m2 on days 1–4 of a 28-day cycle) or placebo plus dexamethasone. Both treatments were administered for 24 weeks (six cycles; randomised comparative study period). Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent 48-week open-label safety study (long-term safety period). The primary end point of the study is the reduction rate of serum VEGF levels at 24 weeks. Ethics and dissemination The protocol was approved by the Institutional Review Board of each hospital. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, Japan (No. 22-1716). The J-POST Trial is currently ongoing and is due to finish in August 2015. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations and will also be disseminated to participants. Trial registration number

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

    PubMed

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

    2015-11-01

    Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention intervention, tried to balance the real-life scenario of no reimbursement for attendance at public sector clinics with that of a trial including some visits that focused on research procedures and others that focused on standard of care procedures. A reduced reimbursement was offered for 'standard of care' visits, meant primarily to cover transport costs to and from the clinic only. This impacted negatively on accrual, retention and participant morale, primarily due to the protracted delay in regulatory approval, during which time, the costs of living, including travel costs had increased. Relevant guidelines were reviewed and institutional policy was updated to incorporate the South African National Health Research Ethics Committee guidelines on reimbursement (taking into account participant time, travel and inconvenience). The reimbursement amount for 'standard of care' visits was increased accordingly. The question remains whether a trial that combines post-trial access with implementation science, with clear benefits for the participants and the provision of above standard medical care, should have reimbursement rates that approach those of a proof-of-concept trial, for 'standard of care' visits. PMID:26392172

  4. 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…

  5. SIV DNA vaccine trial in macaques: post-challenge necropsy in vaccine and control groups.

    PubMed

    Lu, S; Manson, K; Wyand, M; Robinson, H L

    1997-06-01

    In this study we describe the histopathologic findings from nine macaques in a simian immunodeficiency virus (SIV) DNA vaccine trial evaluating the ability of a 5-plasmid DNA vaccine to protect against an uncloned SIVmac251 challenge (Lu et al., J. Virol. 1996, 70, 3978-3991). Three vaccinated and one control macaque developed disease and were euthanized in the first year following challenge. The other four vaccinated and one control macaque remained clinically normal and were euthanized at the end of the trial (60 weeks post-challenge). The necropsy data revealed that both diseased and clinically normal macaques had developed typical SIV-related lymphoid changes, inflammatory disorders and opportunistic infections. All animals had variable degrees of follicular and/or paracortical lymphoid hyperplasia suggesting immune activation. All but one vaccinated macaque and both control macaques had SIV-associated opportunistic infections. Within the small groups of animals, the ability to contain opportunistic infections was superior, and the overall lymphoid changes less severe, in the macaques that had received vaccine DNAs by three routes of inoculation (intravenous, intramuscular and gene gun) than in those that had received control DNAs or vaccine DNAs by gene gun only. In the future it will be important to further test how the route and method of DNA inoculation impact the efficacy of immunodeficiency virus vaccines. PMID:9234548

  6. 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

  7. Radiological evaluation of post-tracheostomy lesions

    PubMed Central

    Macmillan, Alexander S.; James, A. Everette; Stitik, Frederick P.; Grillo, Hermes C.

    1971-01-01

    Post-tracheostomy lesions are becoming more commonplace and surgical techniques for definitive repair of these abnormalities are being developed. These lesions, in general, occur at two sites, the proximal lesions at the tracheostomy incision and the distal lesions 1·5 to 2·5 cm inferior in the area of the tracheostomy balloon cuff. Granuloma formation, stenosis, tracheomalacia, and perforation of the tracheal wall have been encountered in our experience. Clinical symptoms depend upon the type and location of the lesion as well as on the patient's awareness and physical activity. Radiological evaluation offers an accurate method to depict the anatomical and physiological alterations. This radiological assessment should begin with routine postero-anterior and lateral chest radiographs followed by fluoroscopy. Laminograms and special oblique views are often helpful. Contrast tracheograms using powdered tantalum allow good mucosal detail as well as excellent delineation of structural and physiological abnormalities. Images PMID:5144647

  8. 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. PMID:27378034

  9. Post-perceptual processing during the attentional blink is modulated by inter-trial task expectancies

    PubMed Central

    Sy, Jocelyn L.; Elliott, James C.; Giesbrecht, Barry

    2013-01-01

    The selective processing of goal-relevant information depends on an attention system that can flexibly adapt to changing task demands and expectations. Evidence from visual search tasks indicates that the perceptual selectivity of attention increases when the bottom-up demands of the task increase and when the expectations about task demands engendered by trial history are violated. Evidence from studies of the attentional blink (AB), which measures the temporal dynamics of attention, also indicates that perceptual selectivity during the AB is increased if the bottom-up task demands are increased. The present work tested whether expectations about task demands engendered by trial history also modulate perceptual selectivity during the AB. Two experiments tested the extent to which inter-trial switches in task demands reduced post-perceptual processing of targets presented during the AB. Experiment 1 indexed post-perceptual processing using the event-related potential (ERP) technique to isolate the context sensitive N400 ERP component evoked by words presented during the AB. Experiment 2 indexed post-perceptual processing using behavioral performance to determine the extent to which personal names survive the AB. The results of both experiments revealed that both electrophysiological (Exp. 1) and behavioral (Exp. 2) indices of post-perceptual processing were attenuated when consecutive trials differed in terms of their perceptual demands. The results are consistent with the notion that the selectivity of attention during the AB is modulated not only by within-trial task demands, but also can be flexibly determined by trial-by-trial expectations. PMID:24115924

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

    PubMed

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

    2016-06-01

    Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female HIV transmission. Post-use assay results from three Ring-004 clinical trials showed that of the 25mg drug load, approximately 4mg of dapivirine is released from the matrix ring over a 28-day use period. Data obtained by both in vitro and in vivo studies indicate that dapivirine is released according to a diffusion mechanism, as determined by conformance of both data sets to the Higuchi equation. This, coupled with the low variability associated with batch production over two manufacturing sites and 20 batches of material, provides evidence that post-use ring analysis can contribute to the assessment of adherence to ring use. Limitations of this method include the potential of intra-participant and inter-participant variability and uncertainty associated with measuring the low amount of dapivirine actually released relative to the drug load. Therefore, residual drug levels should not serve as the only direct measurement for microbicide adherence in vaginal ring clinical trials but should preferably be used as part of a multi-pronged approach towards understanding and assessing adherence to vaginal ring use. PMID:27016673

  11. 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

  12. 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

  13. 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

  14. Prediction of responders for outcome measures of Locomotor Experience Applied Post Stroke trial

    PubMed Central

    Dobkin, Bruce H. K.; Nadeau, Stephen E.; Behrman, Andrea L.; Wu, Samuel S.; Rose, Dorian K.; Bowden, Mark; Studenski, Stephanie; Lu, Xiaomin; Duncan, Pamela W.

    2015-01-01

    The Locomotor Experience Applied Post Stroke rehabilitation trial found equivalent walking outcomes for body weight-supported treadmill plus overground walking practice versus home-based exercise that did not emphasize walking. From this large database, we examined several clinically important questions that provide insights into recovery of walking that may affect future trial designs. Using logistic regression analyses, we examined predictors of response based on a variety of walking speed-related outcomes and measures that captured disability, physical impairment, and quality of life. The most robust predictor was being closer at baseline to the primary outcome measure, which was the functional walking speed thresholds of 0.4 m/s (household walking) and 0.8 m/s (community walking). Regardless of baseline walking speed, a younger age and higher Berg Balance Scale score were relative predictors of responding, whether operationally defined by transitioning beyond each speed boundary or by a continuous change or a greater than median increase in walking speed. Of note, the cutoff values of 0.4 and 0.8 m/s had no particular significance compared with other walking speed changes despite their general use as descriptors of functional levels of walking. No evidence was found for any difference in predictors based on treatment group. Clinical Trial Registration ClinicalTrials.gov; NCT00243919, “Locomotor Experience Applied Post Stroke Trial”; http://www.clinicaltrials.gov PMID:24805892

  15. 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

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

    PubMed Central

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

    2004-01-01

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

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

    Pirotta, Marie; Gunn, Jane; Chondros, Patty; Grover, Sonia; Hurley, Susan; Garland, Suzanne

    2004-01-01

    Background Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. Methods/design A randomised placebo-controlled blinded 2 × 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18–50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496 – 124 in each factorial group) is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i) oral lactobacillus versus placebo and (ii) vaginal lactobacillus versus placebo. PMID:15046642

  19. [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". PMID:27220797

  20. Post-occupancy evaluation and acoustics in green buildings

    NASA Astrophysics Data System (ADS)

    Hyde, Rosamund

    2005-04-01

    Post-occupancy evaluation is a process for discerning whether completed buildings are delivering to their occupants and owners the benefits which were set as goals in the design process. Both resource consumption and occupant satisfaction are assessed. Evaluations of seven green buildings in British Columbia have been carried out, including buildings with a range of occupancies and climates. These studies have highlighted acoustics as an area where occupant satisfaction could be improved. This presentation will address three questions. First, what have we learned about acoustics from post-occupancy evaluation of green buildings? Results of the seven post-occupancy evaluations of green buildings will be discussed. Second, what questions do designers have about decisions related to acoustics in green buildings? Third, how can we improve post-occupancy evaluation processes to better address those questions?

  1. 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…

  2. 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

  3. Augmented trial designs for evaluation of principal surrogates.

    PubMed

    Gabriel, Erin E; Follmann, Dean

    2016-07-01

    Observation of counterfactual intermediate responses, and evaluation of them as candidate surrogates, is complicated in a standard randomized trial as half of the responses are systematically missing by design. Although some augmentation procedures exist for obtaining counterfactual responses, they are specific to vaccine trials. We outline extensions to the existing augmentations and suggest augmentations of three trial designs outside the setting of vaccines. We outline the assumptions needed to identify the causal estimands of interest under each augmented design, under which standard likelihood-based methods can be used to evaluate intermediate responses as principal surrogates. Two of these designs, crossover and individual stepped-wedge, allow for the observation of clinical endpoints under both treatment and control for some subset of subjects and can therefore improve efficiency over standard parallel trial designs. The third, the treatment run-in design, allows for the observation of a baseline measure that may be as useful a surrogate as the true counterfactual intermediate response. As the evaluation methods rely on several assumptions, we also outline a remediation analysis, which can be used to help overcome assumption violations. We illustrate our suggested methods in an example from a drug-resistant tuberculosis treatment trial. PMID:26825099

  4. Post Occupancy Evaluation of Educational Buildings and Equipment.

    ERIC Educational Resources Information Center

    Watson, Chris

    1997-01-01

    Details the post occupancy evaluation (POE) process for public buildings. POEs are used to improve design and optimize educational building and equipment use. The evaluation participants, the method used, the results and recommendations, model schools, and classroom alterations using POE are described. (9 references.) (RE)

  5. 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

  6. 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. PMID:25954590

  7. 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

  8. [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. PMID:22292397

  9. Acupuncture is a feasible treatment for post-thoracotomy pain: results of a prospective pilot trial

    PubMed Central

    Vickers, Andrew J; Rusch, Valerie W; Malhotra, Vivek T; Downey, Robert J; Cassileth, Barrie R

    2006-01-01

    Background Thoracotomy is associated with severe pain that may persist for years. Acupuncture is a complementary therapy with a proven role in pain control. A randomized trial showed that acupuncture was effective in controlling pain after abdominal surgery, but the efficacy of this technique for the treatment of thoracotomy pain has not been established. We developed a novel technique for convenient application of acupuncture to patients undergoing thoracotomy, and in a Phase II trial evaluated the safety of this intervention and the feasibility of doing a randomized trial. Methods Adult patients scheduled for unilateral thoracotomy with preoperative epidural catheter placement received acupuncture immediately prior to surgery. Eighteen semi-permanent intradermal needles were inserted on either side of the spine, and four were inserted in the legs and auricles. Needles were removed after four weeks. Using a numerical rating scale, pain was measured on the first five postoperative days. After discharge, pain was assessed using the Brief Pain Inventory at 7, 30, 60 and 90 days. Results Thirty-six patients were treated with acupuncture. Of these, 25, 23, and 22 patients provided data at 30, 60, and 90 days, respectively. The intervention was well tolerated by patients with only one minor and transient adverse event of skin ulceration. Conclusion The rate of data completion met our predefined criterion for determining a randomized trial to be feasible (at least 75% of patients tolerated the intervention and provided evaluable data). This novel intervention is acceptable to patients undergoing thoracotomy and does not interfere with standard preoperative care. There was no evidence of important adverse events. We are now testing the hypothesis that acupuncture significantly adds to standard perioperative pain management in a randomized trial. PMID:16672065

  10. Subjects’ views of obligations to ensure post-trial access to drugs, care, and information: Qualitative results from the Experiences of Participants in Clinical Trials (EPIC) Study

    PubMed Central

    Sofaer, Neema; Thiessen, Carrie; Goold, Susan Dorr; Ballou, Janice; Getz, Kenneth A.; Koski, Greg; Krueger, Richard A.; Weissman, Joel S.

    2011-01-01

    Objectives To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care, and information. Design Focus groups, short self-administered questionnaires. Setting Boston, Dallas, Detroit, Oklahoma City. Participants Current and recent subjects in clinical trials, primarily for chronic diseases. Results Ninety-three individuals participated in ten focus groups. Many thought researchers, sponsors, health insurers, and others share obligations to facilitate PTA to the trial drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice, and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. PMID:19251971

  11. Why caution is recommended with post-hoc individual patient matching for estimation of treatment effect in parallel-group randomized controlled trials: the case of acute stroke trials.

    PubMed

    Jafari, Nahid; Hearne, John; Churilov, Leonid

    2013-11-10

    A post-hoc individual patient matching procedure was recently proposed within the context of parallel group randomized clinical trials (RCTs) as a method for estimating treatment effect. In this paper, we consider a post-hoc individual patient matching problem within a parallel group RCT as a multi-objective decision-making problem focussing on the trade-off between the quality of individual matches and the overall percentage of matching. Using acute stroke trials as a context, we utilize exact optimization and simulation techniques to investigate a complex relationship between the overall percentage of individual post-hoc matching, the size of the respective RCT, and the quality of matching on variables highly prognostic for a good functional outcome after stroke, as well as the dispersion in these variables. It is empirically confirmed that a high percentage of individual post-hoc matching can only be achieved when the differences in prognostic baseline variables between individually matched subjects within the same pair are sufficiently large and that the unmatched subjects are qualitatively different to the matched ones. It is concluded that the post-hoc individual matching as a technique for treatment effect estimation in parallel-group RCTs should be exercised with caution because of its propensity to introduce significant bias and reduce validity. If used with appropriate caution and thorough evaluation, this approach can complement other viable alternative approaches for estimating the treatment effect. PMID:23761106

  12. 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

  13. 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

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

    PubMed

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

    2016-06-01

    The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue. PMID:26936446

  15. 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

  16. Ebola virus disease candidate vaccines under evaluation in clinical trials.

    PubMed

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

    2016-09-01

    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

  17. Controlled trials in the evaluation of counselling in general practice.

    PubMed Central

    King, M; Broster, G; Lloyd, M; Horder, J

    1994-01-01

    In this paper the difficulties of conducting a controlled evaluation of counselling (brief psychotherapy) in general practice are discussed. Results of a pilot study indicate that patients referred by family doctors to counsellors are often seriously emotionally distressed and recovery is slow. Counsellors come from different backgrounds and use a variety of therapies. Although the results show that controlled research is feasible, in a definitive trial patients should be randomized in a stratified manner, according to severity, by the researcher after initial assessments have been made. Counsellors should have a recognized accreditation and preferably be employed for the trial to ensure uniformity of approach and avoid long waiting lists. Blind assessments of outcome are desirable but are not always feasible and reliance on patient self-report is important. Within the limitations of current knowledge, only controlled evaluations will provide a greater understanding of the efficacy of counselling in general practice. PMID:8204338

  18. 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

  19. Application of 'nose-poke habituation' validation with post-trial diazepam- and cholecystokinin-induced hypo- and hypermnesia.

    PubMed

    Voits, M; Fink, H; Gerhardt, P; Huston, J P

    1995-03-01

    The present study describes the use of nose-poke habituation as a memory task and demonstrates that it is sensitive to hypo- and hypermnestic pharmacological treatments administered post-trial. Habituation of nose-poke behavior of rats was defined as a reduction in number of nose-pokes compared to baseline. It was measured using a board with 16 holes, to which animals were exposed on 2 consecutive days (baseline and test) for 10 min, respectively. After the first exposure, rats were injected intraperitoneally (i.p.) immediately or with a delay of 2.5 h with doses of diazepam (0.9-4.5 mg/kg) known to be hypomnestic, or cholecystokinin (CCK-8S; 0.2-25 micrograms/kg), which was reported to have memory facilitating effects. An enhancement of habituation in comparison with vehicle controls was interpreted in terms of a hypermnestic effect of the treatment. Conversely, hypomnestic action of the drug treatment was inferred from a reduced habituation. The results show that when diazepam was injected immediately post-trial, the normal reduction in number of nose-pokes during test was prevented, indicative of a failure to habituate presumably due to an amnesia for the baseline/training trial. In contrast, enhanced habituation (facilitation of memory) was induced when CCK-8S was injected immediately post-trial, as reflected by a decrease in number of nose-pokes during test compared to control animals. The effects were not due to enduring proactive effects of the compounds on performance during test, since post-trial injections of diazepam or CCK-8S with a delay of 2.5 h did not have the effects that immediate post-trial injection had.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:7791360

  20. Post-Injection Endophthalmitis in the Comparison of AMD Treatments Trials (CATT)

    PubMed Central

    Meredith, Travis A.; McCannel, Colin A.; Barr, Charles; Doft, Bernard H.; Peskin, Ellen; Maguire, Maureen G.; Martin, Daniel F.; Prenner, Jonathan L.

    2015-01-01

    Objective To describe the incidence and outcomes of endophthalmitis after intravitreal injections of anti-VEGF agents in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT) and to assess the effect of use of prophylactic topical antimicrobials on incidence. Design Cohort study within a randomized clinical trial. Participants Patients enrolled in CATT. Methods Patients with neovascular age-related macular degeneration received intravitreal injections of ranibizumab or bevacizumab under one of three dosing regimens. The study protocol specified pre-injection preparation to include use of a sterile lid speculum and povidone iodine (5%). Use of pre-and post-injection antibiotics was at the discretion of the treating ophthalmologist. Patients were followed monthly for two years. Main Outcome Measures Development of endophthalmitis and visual acuity. Results Endophthalmitis developed after 11 of 18,509 injections (1 per 1,700; 0.06%; 95% Confidence Interval (0.03%, 0.11%)), and among 11 of 1185 patients (0.93%; 95% Confidence Interval (0.52, 1.66)). Incidence of endophthalmitis was 0.15% among injections with no antibiotic use, 0.08% among injections with pre-injection antibiotics only, 0.06% among injections with post-injection antibiotics only, and 0.04% among injections with pre-and post-injection antibiotics (p=0.20). All eyes were treated with intravitreal antibiotics and 4 had vitrectomy. Among the 11 affected eyes, the final study visual acuity was 20/40 or better in 4 (36%) eyes, 20/50-20/80 in 2 (18%) eyes, 20/100-20/160 in 3 (27%) , and <20/800 in 2 (18%) eyes. The final visual acuity was within 2 lines of the visual acuity before endophthalmitis in 5 (45%) eyes. Conclusion Rates of endophthalmitis were low and similar to those in other large scale studies. Use of topical antibiotics either before or after injection does not appear to reduce the risk for endophthalmitis. PMID:25600198

  1. 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

  2. A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression

    PubMed Central

    2014-01-01

    Background Our previous studies have demonstrated the treatment benefits of dense cranial electroacupuncture stimulation (DCEAS), a novel brain stimulation therapy in patients with major depression, postpartum depression and obsessive-compulsive disorder. The purpose of the present study was to further evaluate the effectiveness of DCEAS combined with body acupuncture and selective serotonin reuptake inhibitors (SSRIs) in patients with post-stroke depression (PSD). Methods In a single-blind, randomized controlled trial, 43 patients with PSD were randomly assigned to 12 sessions of DCEAS plus SSRI plus body electroacupuncture (n = 23), or sham (non-invasive cranial electroacupuncture, n-CEA) plus SSRI plus body electroacupuncture (n = 20) for 3 sessions per week over 4 weeks. Treatment outcomes were measured using the 17-item Hamilton Depression Rating Scale (HAMD-17), the Clinical Global Impression - Severity scale (CGI-S) and Barthel Index (BI), a measure used to evaluate movement ability associated with daily self-caring activity. Results DCEAS produced a significantly greater reduction of both HAMD-17 and CGI-S as early as week 1 and CGI-S at endpoint compared to n-CEA, but subjects of n-CEA group exhibited a significantly greater improvement on BI at week 4 than DCEAS. Incidence of adverse events was not different in the two groups. Conclusions These results indicate that DCEAS could be effective in reducing stroke patients’ depressive symptoms. Superficial electrical stimulation in n-CEA group may be beneficial in improving movement disability of stroke patients. A combination of DCEAS and body acupuncture can be considered a treatment option for neuropsychiatric sequelae of stroke. Trial registration http://www.clinicaltrials.gov, NCT01174394. PMID:25038733

  3. 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. PMID:22789039

  4. 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…

  5. Evaluating competency to stand trial with evidence-based practice.

    PubMed

    Rogers, Richard; Johansson-Love, Jill

    2009-01-01

    Evaluations for competency to stand trial are distinguished from other areas of forensic consultation by their long history of standardized assessment beginning in the 1970s. As part of a special issue of the Journal on evidence-based forensic practice, this article examines three published competency measures: the MacArthur Competence Assessment Tool-Criminal Adjudication (MacCAT-CA), the Evaluation of Competency to Stand Trial-Revised (ECST-R), and the Competence Assessment for Standing Trial for Defendants with Mental Retardation (CAST-MR). Using the Daubert guidelines as a framework, we examined each competency measure regarding its relevance to the Dusky standard and its error and classification rates. The article acknowledges the past polarization of forensic practitioners on acceptance versus rejection of competency measures. It argues that no valuable information, be it clinical acumen or standardized data, should be systematically ignored. Consistent with the American Academy of Psychiatry and the Law Practice Guideline, it recommends the integration of competency interview findings with other sources of data in rendering evidence-based competency determinations. PMID:20018994

  6. Optimised Anaesthesia to Reduce Post Operative Cognitive Decline (POCD) in Older Patients Undergoing Elective Surgery, a Randomised Controlled Trial

    PubMed Central

    Ballard, Clive; Jones, Emma; Gauge, Nathan; Aarsland, Dag; Nilsen, Odd Bjarte; Saxby, Brian K.; Lowery, David; Corbett, Anne; Wesnes, Keith; Katsaiti, Eirini; Arden, James; Amaoko, Derek; Prophet, Nicholas; Purushothaman, Balaji; Green, David

    2012-01-01

    Background The study determined the one year incidence of post operative cognitive decline (POCD) and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age) undergoing elective orthopaedic or abdominal surgery. Methods and Trial Design The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery. Results In the 52 week prospective cohort study (192 surgical patients and 138 controls), mild (χ2 = 17.9 p<0.0001), moderate (χ2 = 7.8 p = 0.005) and severe (χ2 = 5.1 p = 0.02) POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls. In the nested RCT, 81 patients were randomized, 73 contributing to the data analysis (34 intervention, 39 control). In the intervention group mild POCD was significantly reduced at 1, 12 and 52 weeks (Fisher’s Exact Test p = 0.018, χ2 = 5.1 p = 0.02 and χ2 = 5.9 p = 0.015), and moderate POCD was reduced at 1 and 52 weeks (χ2 = 4.4 p = 0·037 and χ2 = 5.4 p = 0.02). In addition there was significant improvement in reaction time at all time-points (Vigilance Reaction Time MWU Z =  −2.1 p = 0.03, MWU Z = −2.7 p = 0.004, MWU Z = −3.0 p = 0.005), in MMSE at one and 52 weeks (MWU Z = −2.9 p = 0.003, MWU Z = −3.3 p = 0.001), and in executive function at 12 and 52 weeks (Trail Making MWU Z = −2.4 p = .0.018, MWU Z = −2.4 p = 0.019). Conclusion POCD is common and persistent in older adults following surgery. The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral

  7. 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

  8. 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

  9. Effect of ondansetron on prevention of post-induction hypotension in elderly patients undergoing general anesthesia: A randomized, double-blind placebo-controlled clinical trial

    PubMed Central

    Golparvar, Mohammad; Saghaei, Mahmoud; Saadati, Mohammad Ali; Farsaei, Shadi

    2015-01-01

    Background: Elderly patients are susceptible to post-induction hypotension. Volume loading and vasopressors for prevention of hypotension in elderly patients may increase perioperative cardiovascular risks. Ondansetron by blocking Bezold–Jarisch reflex (BJR) through inhibition of serotonin receptors has been effective in the prevention of post-spinal hypotension, and bradycardia. Bradycardia frequently accompanies post-induction hypotension in elderly patients, which signifies a possible preventing role for ondansetron. No previous study has evaluated the prophylactic effects of ondansetron for the prevention of post-induction hypotension. Materials and Methods: In this randomized placebo-controlled clinical trial, ondansetron 4 mg was given intravenously to 65 elderly patients, 20 min before induction of general anesthesia, and the rate of post-induction hypotension defined as 25% or more reduction in mean arterial blood pressure, compared with a placebo groups. Results: A total of 114 patients completed the study (58 in ondansetron and 56 in the placebo group). Proportions of post-induction hypotension were 9 (16%) and 25 (45%) in ondansetron and placebo groups, respectively, (P = 0.001). Forty-five patients (40%) developed bradycardia. Rates of bradycardia were not significantly different between two groups. Conclusions: The results of this study show the effectiveness of intravenous ondansetron for prevention of post-induction hypotension in elderly patients. The mechanism of this effect largely is unknown. Role of ondansetron for prevention of post-induction hypotension may not fully understandable by its interaction with BJR, as has been shown in post-spinal hypotension. PMID:26543450

  10. Economic evaluation in long-term clinical trials.

    PubMed

    Hlatky, Mark A; Boothroyd, Derek B; Johnstone, Iain M

    2002-10-15

    Economic endpoints have been increasingly included in long-term clinical trials, but they pose several methodologic challenges, including how best to collect, describe, analyse and interpret medical cost data. Cost of care can be measured by converting billed charges, performing detailed micro-costing studies, or by measuring use of key resources and assigning cost weights to each resource. The latter method is most commonly used, with cost weights based either on empirical regression models or administratively determined reimbursement rates. In long-term studies, monetary units should be adjusted to reflect cost inflation and discounting. The temporal pattern of accumulating costs can be described using a modification of the Kaplan-Meier curve. Regression analyses to evaluate factors associated with cost are best performed on the log of costs due to their typically skewed distribution.Cost-effectiveness analysis attempts to measure the value of a new therapy by calculating the difference in cost between the new therapy and the standard therapy, divided by the difference in benefit between the new therapy and the standard therapy. The cost-effectiveness ratio based on the results of a randomized trial may change substantially with longer follow-up intervals, particularly for therapies that are initially expensive but eventually improve survival. A model that projects long-term patterns of cost and survival expected beyond the end of completed follow-up can provide an important perspective in the setting of limited trial duration. PMID:12325104

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

    PubMed Central

    Galvin, Rose; Cusack, Tara; Stokes, Emma

    2008-01-01

    Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s) assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744) PMID:18570643

  12. An R package for simulation experiments evaluating clinical trial designs.

    PubMed

    Wang, Yuanyuan; Day, Roger

    2010-01-01

    This paper presents an open-source application for evaluating competing clinical trial (CT) designs using simulations. The S4 system of classes and methods is utilized. Using object-oriented programming provides extensibility through careful, clear interface specification; using R, an open-source widely-used statistical language, makes the application extendible by the people who design CTs: biostatisticians. Four key classes define the specifications of the population models, CT designs, outcome models and evaluation criteria. Five key methods define the interfaces for generating patient baseline characteristics, stopping rule, assigning treatment, generating patient outcomes and calculating the criteria. Documentation of their connections with the user input screens, with the central simulation loop, and with each other faciliates the extensibility. New subclasses and instances of existing classes meeting these interfaces can integrate immediately into the application. To illustrate the application, we evaluate the effect of patient pharmacokinetic heterogeneity on the performance of a common Phase I "3+3" design. PMID:21347151

  13. 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...

  14. 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 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...

  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. 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

  17. Validation, clinical trial, and evaluation of a radiology expert system.

    PubMed

    Kahn, C E

    1991-10-01

    The PHOENIX Radiology Consultant is a rule-based expert system which assists physicians in planning radiological work-up strategies. This article describes the methods used to create and validate the system's knowledge base. The feasibility and acceptability of PHOENIX were tested for two years in a clinical trial. During this period, the system was used 1,421 times, an average of 13.7 times per week, primarily by medical students and nonradiologist physicians. Much of the system's use occurred at night and on weekends, when the radiology department was not fully staffed. Several physicians were enlisted to further evaluate the utility of the system. The results of their evaluation indicate that an expert system that helps physicians select diagnostic-imaging studies can serve as a useful and informative component of a radiology information system, and is particularly useful for medical students and physicians in training. PMID:1762580

  18. Evaluation of pre-fabricated root canal posts.

    PubMed

    Hew, Y S; Purton, D G; Love, R M

    2001-03-01

    In this in vitro study, properties of a titanium alloy post recently introduced to the market (IntegraPost), were compared with those of a clinically proven stainless steel post (ParaPost). The IntegraPost has a unique, perforated, spherical head and a microknurled shank surface. The posts were tested for rigidity, for retention within the root canals of extracted teeth and for ability to retain composite resin cores. The two post types exhibited similar properties in core and root canal retention, however, the IntegraPost was significantly less rigid than the ParaPost. PMID:11350574

  19. New evidence from the CAPRICORN Trial: the role of carvedilol in high-risk, post-myocardial infarction patients.

    PubMed

    Sackner-Bernstein, Jonathan D

    2003-01-01

    The CAPRICORN (Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction) trial established that the beta-blocker carvedilol reduces the risk of death in patients with left ventricular dysfunction post myocardial infarction, whether or not the infarct is complicated by clinical heart failure. Thus, the utility of the beta-blocker carvedilol is confirmed in the modern era as an adjunct to revascularization, angiotensin-converting enzyme inhibitors, aspirin, and statins. In addition, the results prompt us to review the prior studies of beta-blockers postinfarction. Critical review of CAPRICORN and earlier beta-blocker studies suggests that specific beta-blockers should be matched to specific clinical scenarios. The COMET (Carvedilol or Metoprolol European Trial) study reinforces this view by establishing that beta-blockers are not simply interchangeable agents. PMID:14564231

  20. 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…

  1. The effect of real-time CPR feedback and post event debriefing on patient and processes focused outcomes: A cohort study: trial protocol

    PubMed Central

    2011-01-01

    Background Cardiac arrest affects 30-35, 000 hospitalised patients in the UK every year. For these patients to be given the best chance of survival, high quality cardiopulmonary resuscitation (CPR) must be delivered, however the quality of CPR in real-life is often suboptimal. CPR feedback devices have been shown to improve CPR quality in the pre-hospital setting and post-event debriefing can improve adherence to guidelines and CPR quality. However, the evidence for use of these improvement methods in hospital remains unclear. The CPR quality improvement initiative is a prospective cohort study of the Q-CPR real-time feedback device combined with post-event debriefing in hospitalised adult patients who sustain a cardiac arrest. Methods/design The primary objective of this trial is to assess whether a CPR quality improvement initiative will improve rate of return of sustained spontaneous circulation in in-hospital-cardiac-arrest patients. The study is set in one NHS trust operating three hospital sites. Secondary objectives will evaluate: any return of spontaneous circulation; survival to hospital discharge and patient cerebral performance category at discharge; quality of CPR variables and cardiac arrest team factors. Methods: All three sites will have an initial control phase before any improvements are implemented; site 1 will implement audiovisual feedback combined with post event debriefing, site 2 will implement audiovisual feedback only and site 3 will remain as a control site to measure any changes in outcome due to any other trust-wide changes in resuscitation practice. All adult patients sustaining a cardiac arrest and receiving resuscitation from the hospital cardiac arrest team will be included. Patients will be excluded if; they have a Do-not-attempt resuscitation order written and documented in their medical records, the cardiac arrest is not attended by a resuscitation team, the arrest occurs out-of-hospital or the patient has previously participated

  2. Post-Tenure Faculty Evaluation: Threat or Opportunity? ASHE-ERIC Higher Education Report No. 1.

    ERIC Educational Resources Information Center

    Licata, Christine M.

    Factors that have led to post-tenure evaluation of faculty are considered, along with limitations of tenure in general and current post-tenure evaluation practices. Positions of advocacy and opposition to post-tenure evaluation are identified, along with practical considerations that institutions might consider before modifying or implementing a…

  3. 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.

  4. Text Messaging to Improve Attendance at Post-Operative Clinic Visits after Adult Male Circumcision for HIV Prevention: A Randomized Controlled Trial

    PubMed Central

    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

    Background 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. Methodology 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. Principal Findings 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). Conclusions 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. Trial Registration ClinicalTrials.gov NCT01186575 PMID:22957034

  5. Living Well with Stroke: Design and Methods for a Randomized-Controlled Trial of a Psychosocial-Behavioral Intervention for Post-Stroke Depression

    PubMed Central

    Mitchell, Pamela H.; Teri, Linda; Veith, Richard; Buzaitis, Ann; Tirschwell, David; Becker, Kyra; Fruin, Michael; Kohen, Ruth; Cain, Kevin C.

    2008-01-01

    Background Depression is a sufficiently common sequela of a completed stroke to warrant intervention to improve mood, social and functional outcome. Pharmacologic trials suggest short-term mood improvement from antidepressant treatment but no studies to date have determined whether these short-term gains can be enhanced and extended by a brief psychosocial/behavioral intervention delivered by advanced practice nurses. Nor have drug trials reported on functional outcomes such as limitations in ability, limitations in participation and overall quality of survival. This randomized controlled trial is designed to evaluate the short and long-term efficacy of a new brief psychosocial/behavioral intervention adjunctive to antidepressant treatment in reducing post-stroke depression (PSD) and improving functional outcomes. Methods 101 ischemic stroke survivors with PSD are randomly assigned to receive a brief psychosocial/behavioral intervention plus antidepressant or usual care, including antidepressants. Outcome measures The primary outcome is reduction in depressive symptom severity (Hamilton Depression Rating Scale) at 12 months following stroke. Secondary outcomes are reductions in limitations in activity (Barthel Index), reduction in limitation in participation and overall stroke impact (Stroke Impact Scale) at 6, 12, and 24 months post- stroke. Factors influencing best response to psychosocial intervention will also be explored. Discussion This paper provides detail on the design and treatment methods of this randomized trial in progress. Findings from this study will provide important information regarding the long-term efficacy of such a behavioral intervention in reducing PSD and subsequent impaired aspects of psychosocial and physical recovery. PMID:18436150

  6. Process Evaluation in the Multicenter Child and Adolescent Trial for Cardiovascular Health (CATCH).

    ERIC Educational Resources Information Center

    McGraw, Sarah A.; And Others

    1994-01-01

    Includes "Design of Process Evaluation (PE) within the Child and Adolescent Trial for Cardiovascular Health,""Classroom PE in a Multicenter Trial,""Food Service Program PE,""Physical Activity PE,""Family PE,""PE of Environmental Factors and Programs,""Challenges of Conducting PE in a Multicenter Trial." (SK)

  7. 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

  8. Randomized Clinical Trial of Pre-operative Feeding to Evaluate Intestinal Barrier Function in Neonates Requiring Cardiac Surgery

    PubMed Central

    Zyblewski, Sinai C.; Nietert, Paul J.; Graham, Eric M.; Taylor, Sarah N.; Atz, Andrew M.; Wagner, Carol L.

    2015-01-01

    Objective To evaluate intestinal barrier function in neonates undergoing cardiac surgery using lactulose/mannitol (L/M) ratio measurements and to determine correlations with early breast milk feeding. Study design This was a single-center, prospective, randomized pilot study of 27 term neonates (≥37 weeks gestation) requiring cardiac surgery who were randomized to one of two pre-operative feeding groups: 1) nil per os (NPO) vs. 2) trophic (10 cc/kg/day) breast milk feeds. At three time points (pre-op, post-op day 7, and post-op day 14), subjects were administered an oral lactulose/mannitol solution and subsequent L/M ratios were measured using gas chromatography, with higher ratios indicative of increased intestinal permeability. Trends over time in the mean urine L/M ratios for each group were estimated using a general linear mixed model. Results There were no adverse events related to pre-operative trophic feeding. In the NPO group (n=13), the mean urine L/M ratios at pre-op, post-op day 7, and post-op day 14 were 0.06, 0.12, and 0.17, respectively. In the trophic breast milk feeds group (n=14), the mean urine L/M ratios at pre-op, post-op day 7, and post-op day 14 were 0.09, 0.19, and 0.15, respectively. Both groups had significantly higher L/M ratios at post-op day 7 and 14 compared with pre-op (p<0.05). Conclusions Neonates have increased intestinal permeability after cardiac surgery extending to at least post-op day 14. This pilot study was not powered to detect differences in benefit or adverse events comparing NPO with breast milk feeds. Further studies to identify mechanisms of intestinal injury and therapeutic interventions are warranted. Trial registration Registered with ClinicalTrials.gov: NCT01475357. PMID:25962930

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

    PubMed Central

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

    2014-01-01

    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 Points Studies 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

  10. 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…

  11. Prophylactic Azithromycin Therapy After Lung Transplantation: Post hoc Analysis of a Randomized Controlled Trial.

    PubMed

    Ruttens, D; Verleden, S E; Vandermeulen, E; Bellon, H; Vanaudenaerde, B M; Somers, J; Schoonis, A; Schaevers, V; Van Raemdonck, D E; Neyrinck, A; Dupont, L J; Yserbyt, J; Verleden, G M; Vos, R

    2016-01-01

    Prophylactic azithromycin treatment has been demonstrated to improve freedom from bronchiolitis obliterans syndrome (BOS) 2 years after lung transplantation (LTx). In the current study, we re-evaluated the long-term effects of this prophylactic approach in view of the updated classification system for chronic lung allograft dysfunction (CLAD). A retrospective, intention-to-treat analysis of a randomized controlled trial comparing prophylactic treatment with placebo (n = 43) versus azithromycin (n = 40) after LTx was performed. Graft dysfunction (CLAD), graft loss (retransplantation, mortality), evolution of pulmonary function and functional exercise capacity were analyzed 7 years after inclusion of the last study subject. Following LTx, 22/43 (51%) patients of the placebo group and 11/40 (28%) patients of the azithromycin group ever developed CLAD (p = 0.043). CLAD-free survival was significantly longer in the azithromycin group (p = 0.024). No difference was present in proportion of obstructive versus restrictive CLAD between both groups. Graft loss was similar in both groups: 23/43 (53%) versus 16/40 (40%) patients (p = 0.27). Long-term pulmonary function and functional exercise capacity were significantly better in the azithromycin group (p < 0.05). Prophylactic azithromycin therapy reduces long-term CLAD prevalence and improves CLAD-free survival, pulmonary function, and functional exercise capacity after LTx. PMID:26372728

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

    PubMed Central

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

    2016-01-01

    AIM: To determine the efficacy of rectally administered naproxen for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS: 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. RESULTS: 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

  13. Post-Tooth Extraction Bacteraemia: A Randomized Clinical Trial on the Efficacy of Chlorhexidine Prophylaxis

    PubMed Central

    Barbosa, Mario; Prada-López, Isabel; Álvarez, Maximiliano; Amaral, Barbas; de los Angeles, Casares-De-Cal María; Tomás, Inmaculada

    2015-01-01

    Objectives To investigate the development of post-extraction bacteraemia (PEB) after the prophylactic use of chlorhexidine (CHX). Patients and Methods A total of 201 patients who underwent a tooth extraction were randomly distributed into four groups: 52 received no prophylaxis (CONTROL), 50 did a mouthwash with 0.2% CHX before the tooth extraction (CHX-MW), 51 did a mouthwash with 0.2% CHX and a subgingival irrigation with 1% CHX (CHX-MW/SUB_IR) and 48 did a mouthwash with 0.2% CHX and a continuous supragingival irrigation with 1% CHX (CHX-MW/SUPRA_IR). Peripheral venous blood samples were collected at baseline, 30 seconds after performing the mouthwash and the subgingival or supragingival irrigation, and at 30 seconds and 15 minutes after completion of the tooth extraction. Blood samples were analysed applying conventional microbiological cultures under aerobic and anaerobic conditions performing bacterial identification of the isolates. Results The prevalences of PEB in the CONTROL, CHX-MW, CHX-MW/SUB_IR and CHX-MWSUPRA_IR groups were 52%, 50%, 55% and 50%, respectively, at 30 seconds and 23%, 4%, 10% and 27%, respectively, at 15 minutes. The prevalence of PEB at 15 minutes was significantly higher in the CONTROL group than in the CHX-MW group (23% versus 4%; p = 0.005). At the same time, no differences were found between CONTROL group and CHX-MW/SUB_IR or CHX-MW/SUPRA_IR groups. Streptococci (mostly viridans group streptococci) were the most frequently identified bacteria (69–79%). Conclusions Performing a 0.2% CHX mouthwash significantly reduces the duration of PEB. Subgingival irrigation with 1% CHX didn’t increase the efficacy of the mouthwash while supragingival irrigation even decreased this efficacy, probably due to the influence of these maneuvers on the onset of bacteraemia. Clinical Relevance These results confirm the suitability of performing a mouthwash with 0.2% CHX before tooth extractions in order to reduce the duration of PEB. This practice

  14. 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

  15. Twenty Years Post-NIH Revitalization Act: Renewing the Case for Enhancing Minority Participation in Cancer Clinical Trials

    PubMed Central

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

    2014-01-01

    Background The NIH Revitalization Act of 1993 mandated the appropriate inclusion of minorities in all National Institutes of Health-funded research. Twenty years after this Act, the proportion of minority patients enrolled in cancer clinical trials remains persistently low. Clinical trials are the vehicles for the development and evaluation of therapeutic and preventive agents under scientifically rigorous conditions. Without representation in trials, disparities in the cancer burden for minorities are projected to increase. Methods In this review paper, authors counted the frequencies in which minorities were the primary focus of National Cancer Institute-sponsored clinical trials, examined citations from PubMed 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. Results The reporting and analyses of data based on minorities in clinical trials remain inadequate. Less than two percent of the National Cancer Institute's clinical trials focus on any racial/minority population as their primary emphasis. Our review of the literature indicated that the percentage of authors who reported their study sample by race/ethnicity ranged from 1.5% to 58.0%; only 20% of the randomized controlled studies 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. Conclusions Renewing the emphasis for minority participation in clinical trials is warranted. Policy changes are recommended. PMID:24643646

  16. Retention in the NIDA Clinical Trials Network Women and Trauma Study: Implications for Post-Trial Implementation

    PubMed Central

    Pinto, Rogério M.; Campbell, Aimee N. C.; Hien, Denise A.

    2011-01-01

    This study aimed to identify factors that influenced retention in the NIDA-funded Women and Trauma Study, conducted within the Clinical Trials Network (CTN). Women (N=346) were recruited from and received treatment in 6 CTN-affiliated sites. Log-linear and logistic models were used to explore factors associated with retention. The mean number of treatment sessions attended was 6.8 (SD = 3.9). Women with more education, higher attendance at 12-step meetings, and strong therapeutic alliance between facilitator and participant had better retention rates. Significant site differences were found; the site with the highest retention rate provided child care and had the lowest average monthly intake. To retain women with histories of trauma and substance abuse in “real world” psychiatric settings, emphasis on regulating individual-level and site-related modifiable variables are crucial. PMID:21486263

  17. One versus two years of elastic compression stockings for prevention of post-thrombotic syndrome (OCTAVIA study): randomised controlled trial

    PubMed Central

    Mol, G C; van de Ree, M A; Klok, F A; Tegelberg, M J A M; Sanders, F B M; Koppen, S; de Weerdt, O; Koster, T; Hovens, M M C; Kaasjager, H A H; Brouwer, R E; Kragten, E; Schaar, C G; Spiering, W; Arnold, W P; Biesma, D H

    2016-01-01

    Objective To study whether stopping elastic compression stockings (ECS) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis. Design Multicentre single blind non-inferiority randomised controlled trial. Setting Outpatient clinics in eight teaching hospitals in the Netherlands, including one university medical centre. Participants Patients compliant with compression therapy for 12 months after symptomatic, ultrasound proven proximal deep venous thrombosis of the leg. Interventions Continuation or cessation of ECS 12 months after deep venous thrombosis. Main outcome measures The primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis, as assessed by the standardised Villalta scale in an intention to treat analysis. The predefined non-inferiority margin was 10%. The main secondary outcome was quality of life (VEINES-QOL/Sym). Results 518 patients compliant with ECS and free of post-thrombotic syndrome were randomised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year. In the stop-ECS group, 51 of 256 patients developed post-thrombotic syndrome, with an incidence of 19.9% (95% confidence interval 16% to 24%). In the continue-ECS group, 34 of 262 patients developed post-thrombotic syndrome (incidence 13.0%, 9.9% to 17%), of whom 85% used ECS six or seven days a week during the study period, for an absolute difference of 6.9% (95% confidence interval upper limit 12.3%). Because the upper limit of the 95% confidence interval exceeds the predefined margin of 10%, non-inferiority was not reached. The number needed to treat to prevent one case of post-thrombotic syndrome by continuing ECS was 14 (95% confidence interval lower limit 8). Quality of life did not differ between the two groups. Conclusion Stopping ECS after one year in compliant patients with proximal deep venous thrombosis seemed not to be non

  18. 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

  19. 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

  20. 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…

  1. Evaluation of post-mortem lateral cerebral ventricle changes using sequential scans during post-mortem computed tomography.

    PubMed

    Hasegawa, Iwao; Shimizu, Akinobu; Saito, Atsushi; Suzuki, Hideto; Vogel, Hermann; Püschel, Klaus; Heinemann, Axel

    2016-09-01

    In the present study, we evaluated post-mortem lateral cerebral ventricle (LCV) changes using computed tomography (CT). Subsequent periodical CT scans termed "sequential scans" were obtained for three cadavers. The first scan was performed immediately after the body was transferred from the emergency room to the institute of legal medicine. Sequential scans were obtained and evaluated for 24 h at maximum. The time of death had been determined in the emergency room. The sequential scans enabled us to observe periodical post-mortem changes in CT images. The series of continuous LCV images obtained up to 24 h (two cases)/16 h (1 case) after death was evaluated. The average Hounsfield units (HU) within the LCVs progressively increased, and LCV volume progressively decreased over time. The HU in the cerebrospinal fluid (CSF) increased at an individual rate proportional to the post-mortem interval (PMI). Thus, an early longitudinal radiodensity change in the CSF could be potential indicator of post-mortem interval (PMI). Sequential imaging scans reveal post-mortem changes in the CSF space which may reflect post-mortem brain alterations. Further studies are needed to evaluate the proposed CSF change markers in correlation with other validated PMI indicators. PMID:27048214

  2. PROSPERA: a randomized, controlled trial evaluating rasagiline in progressive supranuclear palsy.

    PubMed

    Nuebling, Georg; Hensler, Mira; Paul, Sabine; Zwergal, Andreas; Crispin, Alexander; Lorenzl, Stefan

    2016-08-01

    To date, pharmacological treatment options for progressive supranuclear palsy (PSP), a neurodegenerative tauopathy, are limited. The MAO-B inhibitor rasagiline has shown neuroprotective effects in preclinical models of neurodegeneration. To evaluate the safety, tolerability and therapeutic effect of rasagiline on symptom progression in PSP. In this 1-year randomized, double-blind, placebo-controlled trial, 44 patients fulfilling the NINDS-PSP criteria were randomized to 1 mg/d rasagiline or placebo. The combined primary endpoint included symptom progression as measured by the PSP rating scale (PSP-RS) and the requirement of L-dopa rescue medication. Secondary endpoints included Schwab and England Activities of Daily Living (SEADL), Montgomery-Åsberg Depression Rating Scale, Mini Mental State Examination, Frontal Assessment Battery and posturographic measurements. Of the 44 patients randomized, 26 completed the trial per protocol. Rasagiline was well tolerated, with a slight increase of known side effects (hallucinations, ventricular extrasystoles). No effect on the primary endpoint (p = 0.496) was detected. Symptom progression averaged at 11.2 (rasagiline) and 10.8 (placebo) points per year (ΔPSP-RS). No difference was seen in SEADL, depression, cognitive function, frontal executive function and posturographic measurements. Post hoc analyses of PSP-RS subdomains indicate a potential beneficial effect in the "limb motor" subdomain, whereas performance appeared lower in the "mentation" and "history" subdomains in the treatment group. While rasagiline is well tolerated in PSP, a beneficial effect on overall symptom progression was not detected. Post hoc analyses suggest the implementation of more specific endpoints in future studies. PMID:27230855

  3. 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

  4. 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

  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. 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

  8. 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

  9. Sample sizes in dosage investigational clinical trials: a systematic evaluation.

    PubMed

    Huang, Ji-Han; Su, Qian-Min; Yang, Juan; Lv, Ying-Hua; He, Ying-Chun; Chen, Jun-Chao; Xu, Ling; Wang, Kun; Zheng, Qing-Shan

    2015-01-01

    The main purpose of investigational phase II clinical trials is to explore indications and effective doses. However, as yet, there is no clear rule and no related published literature about the precise suitable sample sizes to be used in phase II clinical trials. To explore this, we searched for clinical trials in the ClinicalTrials.gov registry using the keywords "dose-finding" or "dose-response" and "Phase II". The time span of the search was September 20, 1999, to December 31, 2013. A total of 2103 clinical trials were finally included in our review. Regarding sample sizes, 1,156 clinical trials had <40 participants in each group, accounting for 55.0% of the studies reviewed, and only 17.2% of the studies reviewed had >100 patient cases in a single group. Sample sizes used in parallel study designs tended to be larger than those of crossover designs (median sample size 151 and 37, respectively). In conclusion, in the earlier phases of drug research and development, there are a variety of designs for dosage investigational studies. The sample size of each trial should be comprehensively considered and selected according to the study design and purpose. PMID:25609916

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

    PubMed Central

    2012-01-01

    Background Foot problems associated with Systemic Sclerosis (SSc)/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale) prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122 PMID:22309847

  11. POST-HARVEST STORAGE EFFECTS ON GUAYULE LATEX QUALITY FROM AGRONOMIC TRIALS

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Current guayule commercialization efforts are based upon the production of hypoallergenic latex. However, little is known about the optimal agronomic conditions for maximum latex production. A series of agronomic trials were carried out over four years to investigate latex yield and quality in diffe...

  12. 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

  13. Low risk of late post-traumatic seizures following severe head injury: implications for clinical trials of prophylaxis.

    PubMed Central

    McQueen, J K; Blackwood, D H; Harris, P; Kalbag, R M; Johnson, A L

    1983-01-01

    A randomised, controlled, double-blind clinical trial designed to determine the effectiveness of phenytoin in preventing epilepsy in patients who had suffered a serious head injury is reported. One hundred and sixty-four patients were randomly assigned to treatment with phenytoin or placebo capsules for one year. Patients who had a fit within one week of injury were excluded. Drug levels were monitored throughout with appropriate dosage adjustment; however only 48% of the phenytoin group had plasma levels greater than 40 mumol/l. There were seven deaths during the study. Only 11 patients (six in the phenytoin group and five in the placebo group) developed post-traumatic epilepsy within one year; a further four patients developed seizures between 1 and 2 years after injury. This low incidence of post-traumatic epilepsy (7% (SE 2%) at one year and 10 (SE 2%) at two years) means that future clinical trials of prophylaxis will have to be much larger (at least six fold). PMID:6417279

  14. Clinical trials in palliative care: an ethical evaluation.

    PubMed

    Janssens, R; Gordijn, B

    2000-08-01

    On first sight, clinical trials do not seem to fit well within the concept of palliative care. In palliative care, the needs and wishes of the patient set the norm while participation in experimental trials is potentially harmful for the patient. The dilemma seems hard to solve as optimal care for the dying and improvement of treatment for future patients are both imperative. Yet, the one seems to exclude the other. However, on closer examination it becomes less evident that clinical trials in palliative care confront us with an unsolvable dilemma. Some patients' lives may gain meaning through participation in trials out of solidarity with future patients. In order to clarify this, the notions of authenticity and hope can be illuminative. PMID:10900367

  15. A Cluster Randomised Controlled Effectiveness Trial Evaluating Perinatal Home Visiting among South African Mothers/Infants

    PubMed Central

    Rotheram-Borus, Mary Jane; Tomlinson, Mark; le Roux, Ingrid M.; Harwood, Jessica M.; Comulada, Scott; O'Connor, Mary J.; Weiss, Robert E.; Worthman, Carol M.

    2014-01-01

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

  16. 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. PMID:26879897

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

    PubMed Central

    2013-01-01

    Background Physical activity is reduced during the post-partum period. Facebook is frequently used by Australian mothers, and offers flexibility, high levels of engagement and the ability to disseminate information and advice via social contacts. The Mums Step it Up Program is a newly developed 50 day team-based physical activity intervention delivered via a Facebook app. The program involves post-partum women working in teams of 4–8 friends aiming to achieve 10,000 steps per day measured by a pedometer. Women are encouraged to use the app to log their daily steps and undertake social and supportive interactions with their friends and other participants. This study aims to determine the effectiveness of the Mums Step it Up Program. Method/design A sample of 126 women up to 12 months post-partum will be recruited through community-based health and family services. Participants will be randomly allocated into one of three groups: control, pedometer only and the Mums Step it Up Program. Assessments will be completed at baseline, 6 weeks and 6 months. The primary outcome (objective physical activity) and the secondary outcomes (sleep quality and quantity, depressive symptoms, weight and quality of life) will be used to determine the effectiveness of the Mums Step it Up Program compared with the control and pedometer only groups. Analyses will be undertaken on an intention-to-treat-basis using random effects mixed modeling. The effect of theorized mediators (physical activity attitudes, subjective norms and perceived behavioral control) will also be examined. Discussion This study will provide information about the potential of a Facebook app for the delivery of health behavior interventions. If this intervention proves to be effective it will be released on a mass scale and promoted to the general public. Trial registration Australia and New Zealand Clinical Trials Register: ACTRN12613000069752 PMID:23714411

  18. 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…

  19. Post-stroke dysphagia: A review and design considerations for future trials.

    PubMed

    Cohen, David L; Roffe, Christine; Beavan, Jessica; Blackett, Brenda; Fairfield, Carol A; Hamdy, Shaheen; Havard, Di; McFarlane, Mary; McLauglin, Carolee; Randall, Mark; Robson, Katie; Scutt, Polly; Smith, Craig; Smithard, David; Sprigg, Nikola; Warusevitane, Anushka; Watkins, Caroline; Woodhouse, Lisa; Bath, Philip M

    2016-06-01

    Post-stroke dysphagia (a difficulty in swallowing after a stroke) is a common and expensive complication of acute stroke and is associated with increased mortality, morbidity, and institutionalization due in part to aspiration, pneumonia, and malnutrition. Although most patients recover swallowing spontaneously, a significant minority still have dysphagia at six months. Although multiple advances have been made in the hyperacute treatment of stroke and secondary prevention, the management of dysphagia post-stroke remains a neglected area of research, and its optimal management, including diagnosis, investigation and treatment, have still to be defined. PMID:27006423

  20. 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…

  1. Conducting Economic Evaluations Alongside Randomised Trials: Current Methodological Issues and Novel Approaches.

    PubMed

    Hughes, Dyfrig; Charles, Joanna; Dawoud, Dalia; Edwards, Rhiannon Tudor; Holmes, Emily; Jones, Carys; Parham, Paul; Plumpton, Catrin; Ridyard, Colin; Lloyd-Williams, Huw; Wood, Eifiona; Yeo, Seow Tien

    2016-05-01

    Trial-based economic evaluations are an important aspect of health technology assessment. The availability of patient-level data coupled with unbiased estimates of clinical outcomes means that randomised controlled trials are effective vehicles for the generation of economic data. However there are methodological challenges to trial-based evaluations, including the collection of reliable data on resource use and cost, choice of health outcome measure, calculating minimally important differences, dealing with missing data, extrapolating outcomes and costs over time and the analysis of multinational trials. This review focuses on the state of the art of selective elements regarding the design, conduct, analysis and reporting of trial-based economic evaluations. The limitations of existing approaches are detailed and novel methods introduced. The review is internationally relevant but with a focus towards practice in the UK. PMID:26753558

  2. Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: an efficacy trial conducted in the real world.

    PubMed

    Winhusen, Theresa; Brady, Kathleen T; Stitzer, Maxine; Woody, George; Lindblad, Robert; Kropp, Frankie; Brigham, Gregory; Liu, David; Sparenborg, Steven; Sharma, Gaurav; Vanveldhuisen, Paul; Adinoff, Bryon; Somoza, Eugene

    2012-09-01

    Cocaine dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60 mg/day) for cocaine-relapse prevention. The study includes pilot (N=60) and full-scale (estimated N=264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS). The primary outcome measure is maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include cocaine use as assessed by UDS and self-report of cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention. PMID:22613054

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. Designing a trial to evaluate potential treatments for apathy in dementia: the Apathy in Dementia Methylphenidate trial (ADMET)

    PubMed Central

    Drye, Lea T.; Scherer, Roberta W.; Lanctôt, Krista L.; Rosenberg, Paul B.; Herrmann, Nathan; Bachman, David; Mintzer, Jacobo E.

    2012-01-01

    Background Research on efficacious treatments for apathy in Alzheimer’s disease has been hindered by a lack of consensus diagnosis, difficulties in measurement, and studies with small sample sizes. Methods 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’s 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. Conclusion 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’s disease. PMID:23567407

  8. 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. PMID:24114103

  9. 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.

  10. 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…

  11. 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...

  12. 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

  13. 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

  14. A review of trials evaluating nonstatin lipid-lowering therapies.

    PubMed

    Ansell, Benjamin J

    2009-01-01

    Recently reported clinical trials raise doubts on the effectiveness of nonstatin lipid-lowering therapies in reducing the residual risk of cardiovascular events after statin monotherapy. Addition of -torcetrapib to statin therapy increased overall mortality in coronary patients despite a marked increase in high-density lipoprotein cholesterol. Combining ezetimibe with statin therapy neither further reduces carotid atherosclerosis nor slows aortic stenosis, and it has not been shown to be superior to statin monotherapy in reducing cardiovascular events. Clinical trials currently in progress will more clearly delineate the cardiovascular effects of adding either ezetimibe or extended-release niacin/laropiprant to statin therapy. PMID:19080730

  15. 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 Central

    Haase, Nicolai; Wetterslev, Jørn; Perner, Anders

    2016-01-01

    Purpose 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. Methods 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. Results 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. Conclusions 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. PMID:27196104

  16. 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

  17. 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

  18. Folate Augmentation of Treatment--Evaluation for Depression (FolATED): randomised trial and economic evaluation.

    PubMed Central

    Bedson, Emma; Bell, Diana; Carr, Daniel; Carter, Ben; Hughes, Dyfrig; Jorgensen, Andrea; Lewis, Helen; Lloyd, Keith; McCaddon, Andrew; Moat, Stuart; Pink, Joshua; Pirmohamed, Munir; Roberts, Seren; Russell, Ian; Sylvestre, Yvonne; Tranter, Richard; Whitaker, Rhiannon; Wilkinson, Clare; Williams, Nefyn

    2014-01-01

    BACKGROUND Folate deficiency is associated with depression. Despite the biological plausibility of a causal link, the evidence that adding folate enhances antidepressant treatment is weak. OBJECTIVES (1) Estimate the clinical effectiveness and cost-effectiveness of folic acid as adjunct to antidepressant medication (ADM). (2) Explore whether baseline folate and homocysteine predict response to treatment. (3) Investigate whether response to treatment depends on genetic polymorphisms related to folate metabolism. DESIGN FolATED (Folate Augmentation of Treatment - Evaluation for Depression) was a double-blind and placebo-controlled, but otherwise pragmatic, randomised trial including cost-utility analysis. To yield 80% power of detecting standardised difference on the Beck Depression Inventory version 2 (BDI-II) of 0.3 between groups (a 'small' effect), FolATED trialists sought to analyse 358 participants. To allow for an estimated loss of 21% of participants over three time points, we planned to randomise 453. SETTINGS Clinical - Three centres in Wales - North East Wales, North West Wales and Swansea. Trial management - North Wales Organisation for Randomised Trials in Health in Bangor University. Biochemical analysis - University Hospital of Wales, Cardiff. Genetic analysis - University of Liverpool. PARTICIPANTS Four hundred and seventy-five adult patients presenting to primary or secondary care with confirmed moderate to severe depression for which they were taking or about to start ADM, and able to consent and complete assessments, but not (1) folate deficient, vitamin B12 deficient, or taking folic acid or anticonvulsants; (2) misusing drugs or alcohol, or suffering from psychosis, bipolar disorder, malignancy or other unstable or terminal illness; (3) (planning to become) pregnant; or (4) participating in other clinical research. INTERVENTIONS Once a day for 12 weeks experimental participants added 5 mg of folic acid to their ADM, and control participants

  19. 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

  20. Effect of systemic steroids on post-tonsillectomy bleeding and reinterventions: systematic review and meta-analysis of randomised controlled trials

    PubMed Central

    Plante, Jennifer; Zarychanski, Ryan; Lauzier, François; Vigneault, Louise; Moore, Lynne; Boutin, Amélie; Fergusson, Dean A

    2012-01-01

    Objective To evaluate the risk of postoperative bleeding and reintervention with the use of systemic steroids in patients undergoing tonsillectomy. Design Systematic review and meta-analysis of randomised controlled trials. Data sources Medline, Embase, Cochrane Library, Scopus, Web of Science, Intute, Biosis, OpenSIGLE, National Technical Information Service, and Google Scholar were searched. References from reviews identified in the search and from included studies were scanned. Review methods Randomised controlled trials comparing the administration of systemic steroids during tonsillectomy with any other comparator were eligible. Primary outcome was postoperative bleeding. Secondary outcomes were the rate of admission for a bleeding episode, reintervention for a bleeding episode, blood transfusion, and mortality. Results Of 1387 citations identified, 29 randomised controlled trials (n=2674) met all eligibility criteria. Seven studies presented a low risk of bias, but none was specifically designed to systematically identify postoperative bleeding. Administration of systemic steroids did not significantly increase the incidence of post-tonsillectomy bleeding (29 studies, n=2674 patients, odds ratio 0.96 (95% confidence interval 0.66 to 1.40), I²=0%). We observed a significant increase in the incidence of operative reinterventions for bleeding episodes in patients who received systemic steroids (12, n=1178, 2.27 (1.03 to 4.99), I²=0%). No deaths were reported. Sensitivity analyses were consistent with the findings. Conclusions Although systemic steroids do not appear to increase bleeding events after tonsillectomy, their use is associated with a raised incidence of operative reinterventions for bleeding episodes, which may be related to increased severity of bleeding events. Systemic steroids should be used with caution, and the risks and benefits weighed, for the prevention of postoperative nausea and vomiting after tonsillectomy before further research is

  1. 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

  2. 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. PMID:25596344

  3. Evaluation of post-ashed photoresist cleaning using oxidizing chemistries

    SciTech Connect

    Resnick, P.J.; Matlock, C.A.

    1997-08-01

    The use of sulfuric acid based chemistries for the removal of photoresist ashing residue was investigated. Samples were prepared by ion-implanting patterned, UV-hardened photoresist. The efficacy of post-ash cleaning was determined by measuring organic, metallic, and particulate surface concentrations. Sulfuric-nitric mixtures and sulfuric-hydrogen peroxide mixtures were highly effective for the removal of metallic contaminants. Neither chemistry was very effective for particulate and organic residue. Highly effective overall cleaning was observed when a sulfuric acid based clean was followed with an RCA-type process sequence. Redundant cleans provided no additional benefits. Post-ash cleaning may be simplified by either reducing the number of sulfuric acid based cleans, or for certain post-ash applications, by replacing them with RCA-type processes.

  4. 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.

  5. 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

  6. 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

  7. Clinical trial simulation to evaluate population pharmacokinetics and food effect: capturing abiraterone and nilotinib exposures.

    PubMed

    Li, Claire H; Sherer, Eric A; Lewis, Lionel D; Bies, Robert R

    2015-05-01

    The objectives of this study were to determine (1) the accuracy with which individual patient level exposure can be determined and (2) whether a known food effect can be identified in a trial simulation of a typical population pharmacokinetic trial. Clinical trial simulations were undertaken using NONMEM VII to assess a typical oncology pharmacokinetic trial design. Nine virtual trials for each compound were performed for combinations of different levels of between-occasion variability, number of patients in the trial, and magnitude of a food covariate on oral clearance. Less than 5% and 20% bias and precision were obtained in individual clearance estimated for both abiraterone and nilotinib using this design. This design resulted in biased and imprecise population clearance estimates for abiraterone. The between-occasion variability in most trials was captured with less than 30% of percent bias and precision. The food effect was detectable as a statistically significant covariate on oral clearance for abiraterone and nilotinib with percent bias and precision of the food covariate less than 20%. These results demonstrate that clinical trial simulation can be used to explore the ability of specific trial designs to evaluate the power to identify individual and population level exposures, covariate, and variability effects. PMID:25511575

  8. Clinical Trial Simulation to Evaluate Population Pharmacokinetics and Food Effect: Capturing Abiraterone and Nilotinib Exposures

    PubMed Central

    Sherer, Eric A.; Lewis, Lionel D.; Bies, Robert R.

    2015-01-01

    The objectives of this study were to determine (1) the accuracy with which individual patient level exposure can be determined and (2) whether a known food effect can be identified in a trial simulation of a typical population pharmacokinetic trial. Clinical trial simulations were undertaken using NONMEM VII to assess a typical oncology pharmacokinetic trial design. Nine virtual trials for each compound were performed for combinations of different level of between-occasion variability, number of patients in the trial and magnitude of a food covariate on oral clearance. Less than 5% and 20% bias and precision were obtained in individual clearance estimated for both abiraterone and nilotinib using this design. This design resulted biased and imprecise population clearance estimates for abiraterone. The between-occasion variability in most trials was captured with less than 30% of percent bias and precision. The food effect was detectable as a statistically significant covariate on oral clearance for abiraterone and nilotinib with percent bias and precision of the food covariate less than 20%. These results demonstrate that clinical trial simulation can be used to explore the ability of specific trial designs to evaluate the power to identify individual and population level exposures,covariate and variability effects. PMID:25511575

  9. 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…

  10. Evaluating strawberry breeding selections for post-harvest fruit decay

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The annual replicated yield assessments for the USDA-ARS strawberry breeding effort at Beltsville, MD, 2007 and 2008, were used to develop a method of assessing each genotype’s post-harvest decay. Detectability of statistical differences between genotypes was improved by treating harvest × plot comb...

  11. 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 resident), to…

  12. 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…

  13. 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…

  14. Effect of foot and hand massage in post-cesarean section pain control: a randomized control trial.

    PubMed

    Abbaspoor, Zahra; Akbari, Malihe; Najar, Shanaz

    2014-03-01

    One of the problems for mothers in the post-cesarean section period is pain, which disturbs the early relationship between mothers and newborns; timely pain management prevents the side effects of pain, facilitates the recovery of patient, reduces the costs of treatment by minimizing or eliminating the mother's distress, and increases mother-infant interactions. The aim of this study was to determine the effect of hand and foot massage on post-cesarean section pain. This study is a randomized and controlled trial which was performed in Mustafa Khomeini Hospital, Elam, Iran, April 1 to July 30, 2011; it was carried out on 80 pregnant women who had an elective cesarean section and met inclusion criteria for study. The visual analog scale was used to determine the pain intensity before, immediately, and 90 minutes after conducting 5 minutes of foot and hand massage. Vital signs were measured and recorded. The pain intensity was found to be reduced after intervention compared with the intensity before the intervention (p < .001). Also, there was a significant difference between groups in terms of the pain intensity and requests for analgesic (p < .001). According to these findings, the foot and hand massage can be considered as a complementary method to reduce the pain of cesarean section effectively and to decrease the amount of medications and their side effects. PMID:23352729

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

    PubMed

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

    2011-03-01

    Missing not at random (MNAR) post-dropout missing data from a longitudinal clinical trial result in the collection of "biased data," which leads to biased estimators and tests of corrupted hypotheses. In a full rank linear model analysis the model equation, E[Y] = Xβ, leads to the definition of the primary parameter β = (X'X)(-1)X'E[Y], and the definition of linear secondary parameters of the form θ = Lβ = L(X'X)(-1)X'E[Y], including, for example, a parameter representing a "treatment effect." These parameters depend explicitly on E[Y], which raises the questions: What is E[Y] when some elements of the incomplete random vector Y are not observed and MNAR, or when such a Y is "completed" via imputation? We develop a rigorous, readily interpretable definition of E[Y] in this context that leads directly to definitions of β, Bias(β) = E[β] - β, Bias(θ) = E[θ] - Lβ, and the extent of hypothesis corruption. These definitions provide a basis for evaluating, comparing, and removing biases induced by various linear imputation methods for MNAR incomplete data from longitudinal clinical trials. Linear imputation methods use earlier data from a subject to impute values for post-dropout missing values and include "Last Observation Carried Forward" (LOCF) and "Baseline Observation Carried Forward" (BOCF), among others. We illustrate the methods of evaluating, comparing, and removing biases and the effects of testing corresponding corrupted hypotheses via a hypothetical but very realistic longitudinal analgesic clinical trial. PMID:21390998

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

    PubMed Central

    Oliveira-Filho, Alfredo D.; Morisky, Donald E.; Costa, Francisco A.; Pacheco, Sara T.; Neves, Sabrina F.; Lyra-Jr, Divaldo P.

    2014-01-01

    Background Effective interventions to improve medication adherence are usually complex and expensive. Objective To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD. Method A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4). The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates. Results 61 patients were randomized to intervention (n = 30) and control (n = 31) groups. The mean age of the patients was 61 years (SD 12.73), 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3). Medication adherence was correlated to intervention (p = 0.04) and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups. Conclusion The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes. PMID:25590930

  17. Daily fluid intake and outcomes in kidney recipients: post hoc analysis from the randomized ABCAN trial.

    PubMed

    Weber, M; Berglund, D; Reule, S; Jackson, S; Matas, A J; Ibrahim, H N

    2015-03-01

    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-h 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 Angiotensin II Blockade for Chronic Allograft Nephropathy (ABCAN) trial (n = 153) underwent baseline, five-yr biopsies, and annual iothalamate glomerular filtration rate 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/d) did not predict the development of interstitial volume doubling or end-stage renal disease (ESRD) from interstitial fibrosis/tubular atrophy (OR = 3.52, 95% CI 0.4, 31.24, p = 0.26), interstitial volume doubling or all-cause ESRD (OR = 7.04, 95% CI 0.66, 74.87, p = 0.11), 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

  18. Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial

    PubMed Central

    Halimi, Franck; Clémenty, Jacques; Attuel, Patrick; Dessenne, Xavier; Amara, Walid

    2008-01-01

    Aims The ŒDIPE trial examined the safety and efficacy of an abbreviated hospitalization after implantation or replacement of dual-chamber pacemakers (PM) using a telecardiology-based ambulatory surveillance programme. Methods and results Patients were randomly assigned to (i) an active group, discharged from the hospital 24 h after a first PM implant or 4–6 h after replacement, and followed for 4 weeks with Home-Monitoring (HM), or (ii) a control group followed for 4 weeks according to usual medical practices. The primary objective was to confirm that the proportion of patients who experienced one or more major adverse events (MAE) was not higher in the active than in the control group. The study included 379 patients. At least one treatment-related MAE was observed in 9.2% of patients (n = 17) assigned to the active group vs. 13.3% of patients (n = 26) in the control group (P = 0.21), a 4.1% absolute risk reduction (95% CI −2.2 to 10.4; P = 0.98). By study design, the mean hospitalization duration was 34% shorter in the active than in the control group (P < 0.001), and HM facilitated the early detection of technical issues and detectable clinical anomalies. Conclusion Early discharge with HM after PM implantation or replacement was safe and facilitated the monitoring of patients in the month following the procedure. PMID:18775878

  19. 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...

  20. 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

  1. 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.

  2. One Year Post Collaborative Depression Care Trial Outcomes among Predominantly Hispanic Diabetes Safety Net Patients

    PubMed Central

    Ell, Kathleen; Katon, Wayne; Xie, Bin; Lee, Pey-Jiuan; Kapetanovic, Suad; Guterman, Jeffery; Chou, Chih-Ping

    2011-01-01

    Objective To determine sustained effectiveness in reducing depression symptoms and improving depression care one year following intervention completion. Method Of 387 low-income, predominantly Hispanic diabetes patients with major depression symptoms randomized to 12-month socio-culturally adapted collaborative care (psychotherapy and/or antidepressants, telephone symptom monitoring/relapse prevention) or enhanced usual care, 264 patients completed two-year follow-up. Depression symptoms (SCL-20, PHQ-9), treatment receipt, diabetes symptoms, and quality of life were assessed 24 months post-enrollment using intent-to-treat analyses. Results At 24 months, more intervention patients received ongoing antidepressant treatment (38% v 25%, chi-square=5.11, df=1, P=0.02); sustained depression symptom improvement (SCL-20<0.5 (adjusted OR=2.06, 95%CI=1.09–3.90, P=0.03), SCL-20 score (adjusted mean difference −0.22, P=0.001), and PHQ-9 ≥50% reduction (adjusted OR=1.87, 95%CI=1.05–3.32, P=0.03). Over 2 years, improved effects were found in significant study group by time interaction for SF-12 mental health, SDS functional impairment, diabetes symptoms, anxiety, and socioeconomic stressors (P=0.02 for SDS, P<0.0001 for all others); however, group differences narrowed over time and were no longer significant at 24 months. Conclusions Socio-culturally tailored collaborative care that included maintenance antidepressant medication, ongoing symptom monitoring and behavioral activation relapse prevention was associated with depression improvement over 24 months for predominantly Hispanic patients in primary safety net care. PMID:21774987

  3. 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

  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. Using Multilevel Mixtures to Evaluate Intervention Effects in Group Randomized Trials

    ERIC Educational Resources Information Center

    Van Horn, M. Lee; Fagan, Abigail A.; Jaki, Thomas; Brown, Eric C.; Hawkins, J. David; Arthur, Michael W.; Abbott, Robert D.; Catalano, Richard F.

    2008-01-01

    There is evidence to suggest that the effects of behavioral interventions may be limited to specific types of individuals, but methods for evaluating such outcomes have not been fully developed. This study proposes the use of finite mixture models to evaluate whether interventions, and, specifically, group randomized trials, impact participants…

  6. Evaluation of Post Wall Filter for Doppler Ultrasound Systems

    NASA Astrophysics Data System (ADS)

    Baba, T.

    Recent advances in digital devices permit high-performance signal processing to be performed with ease. In conventional Doppler ultrasound examinations, the weak blood flow signals are separated from clutter signals, such as those from the cardiac valves and walls, using a time domain pre wall filter in order to avoid saturation of the subsequent frequency analyzer. At this time, due to the expanded dynamic range in signal processing, we have conducted investigations to determine whether it is possible to eliminate the pre wall filter and replace it with a post wall filter after the frequency analyzer. The results of these investigations showed that it is possible to obtain frequency characteristics equivalent to those obtained with a pre wall filter by compensating for the sampling function in frequency analysis processing and simplifying Doppler signal processing. Moreover, it was found that both blood inflow signals and mitral valve motion in the left ventricle can be observed without saturation, confirming the feasibility of real-time simultaneous display using a post wall filter.

  7. 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…

  8. 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)

  9. 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,…

  10. A 3-year postoperative clinical evaluation of posts and cores beneath existing crowns.

    PubMed

    Hatzikyriakos, A H; Reisis, G I; Tsingos, N

    1992-04-01

    Fabrication of posts and cores for fixed partial denture (FPD) and removable partial denture (RPD) abutment restorations is common in dentistry. The biocompatibility of various post and core techniques with the restorations was clinically evaluated according to location and function. In this study, 154 post and core constructions for 150 patients were observed for a 3-year period to determine if the function of the original restorations remained unsatisfactory. The following techniques were included: (1) screw post and light-curing composite resins, (2) cemented post with parallel sides and light-curing composite resins, and (3) a cast and core technique. Seventeen of the 154 restorations failed; four failures were attributed to root fractures, three to radicular caries, and five to crown dislodgement, while five failures were from detachment of the post and core from the root. The statistical analysis revealed that only the factor "type of abutment" (RPDs and FPDs) had some effect on the failure of the restorations. PMID:1507125

  11. A 3-Year Retrospective Evaluation of the Clinical Performance of Fiber Posts.

    PubMed

    Amaral, Marina; Coppo, Priscilla Pessin; Rosalem, Cíntia Gonçalves Carvalho; Suaid, Fabricia Ferreira; Guerra, Selva Maria Gonçalves

    2015-12-01

    This retrospective study evaluated the clinical outcome of 139 teeth restored with carbon fiber posts after 3 years of placement, considering the amount of remaining dentin as the main variable. Eighty-one patients received the fiber posts within a period of 16 months and were recalled after 3 years. The tooth type, amount of remaining dentin, and prosthetic crown material were evaluated. No loss of post or core retention was detected after 3 years of follow up. During the observed time, root or post fracture and secondary caries were not recorded. Only one failure concerning endodontic treatment was detected. The amount of remaining dentin was not an important characteristic in the restorative failure of endodontically treated teeth restored with carbon fiber posts within 3 years. PMID:26963206

  12. Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies

    PubMed Central

    Schueller, Stephen M; Riley, William T; Brown, C Hendricks; Cuijpers, Pim; Duan, Naihua; Kwasny, Mary J; Stiles-Shields, Colleen; Cheung, Ken

    2015-01-01

    In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology. PMID:26155878

  13. Angel: post-implementation evaluation at the Indiana University School of Medicine.

    PubMed

    Hatfield, Amy J; Brahmi, Frances A

    2004-01-01

    With continued adoption of course management systems, librarians are assuming new roles and challenges with regard to providing information resources and library services in a digital environment. For approximately five years, the Indiana University School of Medicine has employed Angel as its online teaching environment, and the Ruth Lilly Medical Library has been actively involved in the adoption of Angel. As the implementation phase was completed, a post-implementation evaluation was due. The authors conducted an evaluation of the Angel system to evaluate utilization level, content types, and library resources/services integration. This article provides the findings of the post-implementation Angel Courses Evaluation. PMID:15364647

  14. Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: a randomized, controlled trial.

    PubMed

    Morrison, B W; Christensen, S; Yuan, W; Brown, J; Amlani, S; Seidenberg, B

    1999-06-01

    Previous data have suggested that rofecoxib, a cyclooxygenase (COX)-2-specific inhibitor, had analgesic effects similar to those of the nonsteroidal anti-inflammatory drugs when tested in the post-dental surgery pain model. The objective of this parallel-group, double-masked, randomized, placebo- and active comparator-controlled clinical trial was to assess more fully the analgesic efficacy of rofecoxib in the treatment of postoperative dental pain. After dental surgery, 151 patients (50.3% women; mean age, 18.3 years; 93.4% white) experiencing moderate-to-severe pain were to receive a single dose of placebo, rofecoxib 50 mg, or ibuprofen 400 mg. Analgesic efficacy was assessed for up to 24 hours postdose using self-administered questionnaires. Tolerability was assessed using spontaneous reports of adverse experiences, physical findings, and laboratory measurements. The results of this study demonstrated that rofecoxib 50 mg was more effective than placebo on all measures of analgesic efficacy. Rofecoxib 50 mg exhibited overall analgesic effects, onset of analgesia, and peak analgesic effects that were not significantly different from those of ibuprofen 400 mg, with a significantly longer duration of action (P < 0.05). We concluded that rofecoxib was efficacious in the treatment of postoperative dental pain and that COX-2-derived prostanoids play a role in treatment of the pain associated with dental surgery. PMID:10440619

  15. Effect of supplemental oxygen 80 % on post-tonsillectomy nausea and vomiting: a randomized controlled trial.

    PubMed

    Izadi, Poopak; Delavar, Parvin; Yarmohammadi, Mohammad Ebrahim; Daneshmandan, Naimeh; Sadrameli, Maryam

    2016-05-01

    Nausea and vomiting are two of the most common complications of tonsillectomy in children. Administration of supplemental 80 % oxygen during surgery reduces the incidence of postoperative nausea and vomiting. We aimed to test the efficacy of supplemental 80 % oxygen during tonsillectomy on postoperative nausea and vomiting. In a randomized controlled trial in Shahid Mostafa Khomeini Hospital in Tehran, 102 children scheduled for tonsillectomy (±adenoidectomy) under general anesthesia were divided randomly in two groups according to percent of administered oxygen (group 1:30 % oxygen, group 2:80 % oxygen). The incidence of postoperative nausea and vomiting were assessed and compared in 0-2, 2-6 and 6-24 h after surgery. Incidence of post-tonsillectomy nausea and vomiting after 2, 2-6, and 6-24 h was 13.72, 1.96 and 1.96 % for group 1 and 3.92, 0 and 1.96 % in group 2, respectively. We found no statistically significant difference between two groups (P = 0.08) but 80 % oxygen was beneficial for reducing postoperative nausea and vomiting in the first 2 h after surgery in group 2. PMID:26677853

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

    PubMed Central

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

    2014-01-01

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

  17. Evaluating adherence to the International Committee of Medical Journal Editors’ policy of mandatory, timely clinical trial registration

    PubMed Central

    Huser, Vojtech; Cimino, James J

    2013-01-01

    Objective To determine whether two specific criteria in Uniform Requirements for Manuscripts (URM) created by the International Committee of Medical Journal Editors (ICMJE)—namely, including the trial ID registration within manuscripts and timely registration of trials, are being followed. Materials and methods Observational study using computerized analysis of publicly available Medline article data and clinical trial registry data. We analyzed a purposive set of five ICMJE founding journals looking at all trial articles published in those journals during 2010–2011, and data from the ClinicalTrials.gov (CTG) trial registry. We measured adherence to trial ID inclusion policy as the percentage of trial journal articles that contained a valid trial ID within the article (journal-based sample). Adherence to timely registration was measured as the percentage of trials that registered the trial before enrolling the first participant within a 60-day grace period. We also examined timely registration rates by year of all phase II and higher interventional trials in CTG (registry-based sample). Results To determine trial ID inclusion, we analyzed 698 clinical trial articles in five journals. A total of 95.8% (661/690) of trial journal articles included the trial ID. In 88.3% the trial-article link is stored within a structured Medline field. To evaluate timely registration, we analyzed trials referenced by 451 articles from the selected five journals. A total of 60% (272/451) of articles were registered in a timely manner with an improving trend for trials initiated in later years (eg, 89% of trials that began in 2008 were registered in a timely manner). In the registry-based sample, the timely registration rates ranged from 56% for trials registered in 2006 to 72% for trials registered in 2011. Discussion Adherence to URM requirements for registration and trial ID inclusion increases the utility of PubMed and links it in an important way to clinical trial repositories

  18. 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. PMID:19585229

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

    PubMed Central

    Guekht, Alla; Skoog, Ingmar; Korczyn, Amos D.; Zakharov, Vladimir; Eeg, Martin; Vigonius, Ulf

    2013-01-01

    Background No drug treatment to date has shown convincing clinical evidence of restoring cognitive function or preventing further decline after stroke. The ongoing ARTEMIDA study will evaluate the efficacy and safety of Actovegin for the symptomatic treatment of post-stroke cognitive impairment (PSCI) and will explore whether Actovegin has any disease-modifying effect by assessing whether any changes are sustained after treatment. Design ARTEMIDA is a 12-month, multicentre trial in patients (planned a total of 500, now recruited) with cognitive impairment following ischaemic stroke. The study consists of a baseline screening (≤7 days after stroke), after which eligible patients are randomised to Actovegin (2,000 mg/day for up to 20 intravenous infusions followed by 1,200 mg/day orally) or placebo for a 6-month double-blind treatment period. Patients will be followed up for a further 6 months, during which time they will be treated in accordance with standard clinical practice. The primary study endpoint is change from baseline in the Alzheimer's Disease Assessment Scale, cognitive subscale, extended version. Secondary outcomes include: Montreal Cognitive Assessment; dementia diagnosis (ICD-10); National Institutes of Health Stroke Scale; Barthel Index; EQ-5D; Beck Depression Inventory, version II, and safety. Conclusion There is a clear need for effective treatments for PSCI. ARTEMIDA should provide important insights into the use of a novel drug therapy for PSCI. PMID:24516413

  20. Suicidal Thoughts and Reasons for Living in Hospitalized Patients With Severe Depression: Post-Hoc Analyses of a Double-Blind Randomized Trial of Duloxetine

    PubMed Central

    Desaiah, Durisala; Raskin, Joel; Cairns, Victoria; Brecht, Stephan

    2014-01-01

    Objective: To evaluate suicidal thoughts in relationship to depressive symptom severity and reasons for living in patients hospitalized for major depressive disorder (MDD). Method: A post hoc analysis was conducted of a randomized, double-blind, parallel-group trial involving hospitalized patients with MDD (DSM-IV criteria) who received duloxetine 60 mg once daily or duloxetine 60 mg twice daily for 8 weeks. After 4 weeks, the dose for nonresponders receiving 60 mg once daily could be increased to 60 mg twice daily (double-blind). The study was conducted between February 9, 2007, and August 26, 2008 at 43 centers in 4 countries across Europe and South Africa. Suicidal thoughts were assessed with Montgomery-Asberg Depression Rating Scale (MADRS) item 10, depression severity was assessed with the 6-item Hamilton Depression Rating Scale and the Clinical Global Impressions–Severity of Illness scale, and protective factors were assessed with the patient-rated Reasons for Living Inventory (RFL) assessing 6 domains. Descriptive statistics, correlation, and linear regression analysis were performed. Results: At baseline, patients (N = 336) had varying severity of suicidal thoughts: 18% had a score ≥ 4. The proportion of patients with a score ≥ 4 decreased to 7% at week 1 and 1% at week 8 of treatment. The RFL scores at baseline were lower in patients with higher baseline suicidal thoughts and increased significantly during treatment (P < .0001). A regression model revealed that only 16% of variance in baseline total RFL score is explained by the different MADRS items. Eight patients had suicidal behavior or ideation recorded as an adverse event during the study; no consistent pattern was found in the different psychometric scores either at baseline or at the visit preceding the suicidal behavior/ideation. Conclusions: Suicidality rapidly decreased in hospitalized patients with severe depression treated with duloxetine. The RFL scores were low at baseline but

  1. A double-blind, placebo-controlled intervention trial of 3 and 10 mg sublingual melatonin for post-concussion syndrome in youths (PLAYGAME): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background By the age of sixteen, one in five children will sustain a mild traumatic brain injury also known as concussion. Our research found that one in seven school children with mild traumatic brain injury suffer post-concussion syndrome symptoms for three months or longer. Post-concussion syndrome is associated with significant disability in the child and his/her family and yet there are no evidence-based medical treatments available. Melatonin has several potential mechanisms of action that could be useful following mild traumatic brain injury, including neuroprotective effects. The aim of this study is to determine if treatment with melatonin improves post-concussion syndrome in youths following mild traumatic brain injury. Our hypothesis is that treatment of post-concussion syndrome following mild traumatic brain injury with 3 or 10 mg of sublingual melatonin for 28 days will result in a decrease in post-concussion syndrome symptoms compared with placebo. Methods/Design Ninety-nine youths with mild traumatic brain injury, aged between 13 and 18 years, who are symptomatic at 30 days post-injury will be recruited. This study will be conducted as a randomized, double blind, placebo-controlled superiority trial of melatonin. Three parallel treatment groups will be examined with a 1:1:1 allocation: sublingual melatonin 3 mg, sublingual melatonin 10 mg, and sublingual placebo. Participants will receive treatment for 28 days. The primary outcome is a change on the Post-Concussion Symptom Inventory (Parent and Youth). The secondary outcomes will include neurobehavioral function, health-related quality of life and sleep. Neurophysiological and structural markers of change, using magnetic resonance imaging techniques and transcranial magnetic stimulation, will also be investigated. Discussion Melatonin is a safe and well-tolerated agent that has many biological properties that may be useful following a traumatic brain injury. This study will determine whether it is a

  2. Evaluating HPV-negative CIN2+ in the ATHENA trial.

    PubMed

    Petry, Karl Ulrich; Cox, J Thomas; Johnson, Kristin; Quint, Wim; Ridder, Ruediger; Sideri, Mario; Wright, Thomas C; Behrens, Catherine M

    2016-06-15

    A post hoc analysis of the ATHENA study was performed to determine whether true HPV-negative cervical lesions occur and whether they have clinical relevance. The ATHENA database was searched for all CIN2 or worse (CIN2+) cases with cobas HPV-negative results and comparison was made with Linear Array (LA) and Amplicor to detect true false-negative HPV results. Immunostaining with p16 was performed on these cases to identify false-positive histology results. H&E slides were re-reviewed by the study pathologists with knowledge of patient age, HPV test results and p16 immunostaining. Those with positive p16 immunostaining and/or a positive histopathology review underwent whole tissue section HPV PCR by the SPF10/LiPA/RHA system. Among 46,887 eligible women, 497 cases of CIN2+ were detected, 55 of which tested negative by the cobas(®) HPV Test (32 CIN2, 23 CIN3/ACIS). By LA and/or Amplicor, 32 CIN2+ (20 CIN2, 12 CIN3/ACIS) were HPV positive and categorized as false-negatives by cobas HPV; nine of 12 false-negative CIN3/ACIS cases were p16+. There were 23 cases (12 CIN2, 11 CIN3/ACIS) negative by all HPV tests; seven of 11 CIN3/ACIS cases were p16+. H&E slides were available for six cases for re-review and all were confirmed as CIN3/ACIS. Tissue PCR was performed on the six confirmed CIN3/ACIS cases (and one without confirmation): four were positive for HPV types not considered oncogenic, two were positive for oncogenic genotypes and one was indeterminate. In summary, subanalysis of a large cervical cancer screening study did not identify any true CIN3/ACIS not attributable to HPV. PMID:26851121

  3. A Systems Biology Approach Investigating the Effect of Probiotics on the Vaginal Microbiome and Host Responses in a Double Blind, Placebo-Controlled Clinical Trial of Post-Menopausal Women

    PubMed Central

    Bisanz, Jordan E.; Seney, Shannon; McMillan, Amy; Vongsa, Rebecca; Koenig, David; Wong, LungFai; Dvoracek, Barbara; Gloor, Gregory B.; Sumarah, Mark; Ford, Brenda; Herman, Dorli; Burton, Jeremy P.; Reid, Gregor

    2014-01-01

    A lactobacilli dominated microbiota in most pre and post-menopausal women is an indicator of vaginal health. The objective of this double blinded, placebo-controlled crossover study was to evaluate in 14 post-menopausal women with an intermediate Nugent score, the effect of 3 days of vaginal administration of probiotic L. rhamnosus GR-1 and L. reuteri RC-14 (2.5×109 CFU each) on the microbiota and host response. The probiotic treatment did not result in an improved Nugent score when compared to when placebo. Analysis using 16S rRNA sequencing and metabolomics profiling revealed that the relative abundance of Lactobacillus was increased following probiotic administration as compared to placebo, which was weakly associated with an increase in lactate levels. A decrease in Atopobium was also observed. Analysis of host responses by microarray showed the probiotics had an immune-modulatory response including effects on pattern recognition receptors such as TLR2 while also affecting epithelial barrier function. This is the first study to use an interactomic approach for the study of vaginal probiotic administration in post-menopausal women. It shows that in some cases multifaceted approaches are required to detect the subtle molecular changes induced by the host to instillation of probiotic strains. Trial Registration ClinicalTrials.gov NCT02139839 PMID:25127240

  4. 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)

  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. The State of Post-Occupancy Evaluation in the Practice of Educational Design.

    ERIC Educational Resources Information Center

    Lackney, Jeffery A.

    Over the past decade, thousands of new school buildings and renovations have been planned, designed, and constructed in the United States. Of these, only a small fraction will ever be evaluated against the educational needs of students and teachers. This paper reflects on the state of post-occupancy evaluation (POE) in the practice of educational…

  7. 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

  8. 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.

  9. Evaluation of Oral Ginger Efficacy against Postoperative Nausea and Vomiting: A Randomized, Double - Blinded Clinical Trial

    PubMed Central

    Montazeri, Akram Sadat; Hamidzadeh, Azam; Raei, Mehdi; Mohammadiun, Malihe; Montazeri, Azam Sadat; Mirshahi, Reza; Rohani, Hosein

    2013-01-01

    Background: Postoperative nausea and vomiting is one of the most common side effects associated with surgical procedures. Objectives: The aim of this study was to determine the effect of ginger on intensity of nausea and vomiting after surgical procedures. Patients and Methods: This study was a randomized, double blinded, clinical trial. 160 eligible patients were randomly assigned into experimental or placebo groups. The experimental group received 4 capsules containing 250 mg ginger and placebo group received 4 placebo capsules 1 hour before surgery. The severity of nausea and vomiting was measured at 2, 4, 6 hours post operation using visual analogue scale and a structured questionnaire. The data were analyzed by independent t - test, Mann-Whitney U test, chi –square and GEE using SPSS 16 and STATA version 11. Results: Mean nausea score at 2 hours post operation was significantly lower in the experimental group (P= 0.04). Mean nausea score at 4 and 6 hours post operation was lower in the experimental group; however, there was no significant difference between the groups at any time post operation. The frequencies of nausea in the experimental group at 2 and 6 hours post operation were lower than that in the placebo group, however, at 2 hours post operation, it was borderline significant (P = 0.05) There was no significant differences between two group in the intensity of vomiting at any time. Conclusions: Use of ginger was effective at decreasing postoperative nausea. Ginger could be used as a safe antiemetic drug at post operation. PMID:24693389

  10. An Evaluation of Fresh Start as a Catch-Up Intervention: A Trial Conducted by Teachers

    ERIC Educational Resources Information Center

    Gorard, Stephen; Siddiqui, Nadia; See, Beng Huat

    2016-01-01

    This paper describes a randomised controlled trial conducted with 10 secondary schools in England to evaluate the impact and feasibility of Fresh Start as an intervention to help new entrants with low prior literacy. Fresh Start is a synthetic phonics programme for small groups of pupils, here implemented three times per week over 22 weeks. The…

  11. Component Evaluation of a Computer Based Format for Teaching Discrete Trial and Backward Chaining

    ERIC Educational Resources Information Center

    Nosik, Melissa R.; Williams, W. Larry

    2011-01-01

    The effectiveness of a multi-component computer based training package that consisted of competency based instructions, video modeling, and two forms of feedback was evaluated in terms of treatment integrity of two procedures across four staff. Treatment integrity in completing critical steps of discrete-trial and backward chaining procedures were…

  12. An Evaluation of Programmed Treatment-integrity Errors during Discrete-trial Instruction

    ERIC Educational Resources Information Center

    Carroll, Regina A.; Kodak, Tiffany; Fisher, Wayne W.

    2013-01-01

    This study evaluated the effects of programmed treatment-integrity errors on skill acquisition for children with an autism spectrum disorder (ASD) during discrete-trial instruction (DTI). In Study 1, we identified common treatment-integrity errors that occur during academic instruction in schools. In Study 2, we simultaneously manipulated 3…

  13. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  14. Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

    2012-01-01

    This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  16. Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

    ERIC Educational Resources Information Center

    Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

    2009-01-01

    When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

  17. A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

    NASA Astrophysics Data System (ADS)

    Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Lee, Andrew J.; Xiao, Ying

    2013-07-01

    The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10-20 min to 2 min by applying the semi-automated plan-quality evaluation program.

  18. 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.

  19. Fluoroscopic Caudal Epidural Injections in Managing Post Lumbar Surgery Syndrome: Two-Year Results of a Randomized, Double-Blind, Active-Control Trial

    PubMed Central

    Manchikanti, Laxmaiah; Singh, Vijay; Cash, Kimberly A.; Pampati, Vidyasagar; Datta, Sukdeb

    2012-01-01

    Study Design: A randomized, active control, double-blind trial. Objective: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. Summary of Background Data: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome. Methods: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures. Results: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at

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

    PubMed Central

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

    2015-01-01

    Objective To compare analgesia provided by carprofen or tramadol in dogs after enucleation. Design Randomized, masked trial Animals Forty-three dogs Procedures Client-owned dogs admitted for routine enucleation were randomly assigned to receive either carprofen or tramadol orally 2 hours prior to surgery and 12 hours after the first dose. Dogs were scored for pain at baseline, and postoperatively at 0.25, 0.5, 1, 2, 4, 6, 8, 24, and 30 hours after extubation. Dogs received identical premedication and inhalation anesthesia regimens, including premedication with hydromorphone. If the total pain score was ≥9, if there was a score ≥ 3 in any one category, or if the visual analog scale score (VAS) was ≥35 combined with a palpation score of >0, rescue analgesia (hydromorphone) was administered and treatment failure was recorded. Characteristics between groups were compared with a Student’s t-test and Fisher’s exact test. The incidence of rescue was compared between groups using a log rank test. Pain scores and VAS scores between groups were compared using repeated measures ANOVA. Results There was no difference in age (p=0.493), gender (p=0.366) or baseline pain scores (p=0.288) between groups. Significantly more dogs receiving tramadol required rescue analgesia (6/21) compared to dogs receiving carprofen (1/22; p=0.035). Pain and VAS scores decreased linearly over time (p=0.038, p<0.001, respectively). There were no significant differences in pain (p=0.915) or VAS scores (p=0.372) between groups at any time point (dogs were excluded from analysis after rescue). Conclusions and Clinical Relevance This study suggests that carprofen, with opioid premedication, provides more effective post-operative analgesia than tramadol in dogs undergoing enucleation. PMID:25459482

  1. Evaluating the first-in-human clinical trial of a human embryonic stem cell-based therapy.

    PubMed

    Chapman, Audrey R; Scala, Courtney C

    2012-09-01

    Phase I clinical trials generally raise greater ethical and human protection challenges than later stage clinical trials, suggesting a need to proceed cautiously. This is particularly the case for Phase I trials with a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials. In January 2009, the Food and Drug Administration approved the Investigational New Drug application of Geron Corporation, a small California-based biopharmaceutical company, to initiate a clinical trial to assess GRNOPC1, a human embryonic stem cell-derived candidate therapy for severe spinal cord injuries. This article evaluates the ethical and human subject protection issues raised by the Geron FIH trial. It identifies problems with the approval process and with the conduct of the trial, and then recommends ways to improve review of future proposed trials with novel and high-risk therapies. PMID:23285793

  2. Wide Awake Parenting: study protocol for a randomised controlled trial of a parenting program for the management of post-partum fatigue

    PubMed Central

    2013-01-01

    Background Exhaustion and fatigue are commonly experienced by parents during the post-partum period, and can have implications for daily functioning, mental health and parenting practices. There is a need for the development of effective interventions to assist parents with the management of fatigue. This paper outlines the procedure for a randomised controlled study which aims to test the efficacy of Wide Awake Parenting, a program for the management of fatigue in the postnatal period. Methods/design Parents with an infant less than 6 months of age, and from seven Local Government Areas in Melbourne, Australia were invited to participate in this study. Parents were randomised to receive the Wide Awake Parenting program (intervention groups) or usual care (control group) offered by health services. The Wide Awake Parenting program provides parents with psycho-education and information about fatigue, and strategies to reduce its effects either via a self-directed method, or professionally led with a home visit and telephone support. Baseline data will be collected prior to randomisation, and further data will be collected at 2- and 6-weeks post intervention. Discussion To our knowledge this is the first randomised controlled trial of a program which compares the efficacy of a self-management approach and health professional assistance for the management of fatigue in the early post-partum period. If effective, it could offer an important, universal public health management approach to this common health concern. Trial registration number Australian New Zealand Clinical Trials Registry, ACTRN12611000133932. PMID:23311498

  3. The effect of short-term vitamin D supplementation on lipid profile and blood pressure in post-menopausal women: A randomized controlled trial

    PubMed Central

    Moghassemi, Sedigheh; Marjani, Abdoljalal

    2014-01-01

    Background: Hypovitaminosis D has been associated with a series of cardiovascular risk factors, such as hypertension, metabolic disorders, obesity, peripheral artery disease, coronary artery disease, myocardial infarction, heart failure and stroke. Objective: To assess the effect of oral vitamin D3 on cardiovascular risk factors in post-menopausal women with vitamin D insufficiency. Materials and Methods: In this parallel, randomized, placebo-controlled trial, 76 healthy post-menopausal women with vitamin D insufficiency (defined as a 25-[OH] D level <75 nmol/L) were randomly assigned to receive vitamin D3 2000 IU once daily (n = 38) or placebo (n = 38). The trial was undertaken in the different health centers in Gorgan, north of Iran. Lipid profile, fasting blood sugar (FBS) and blood pressure of the patients was assessed at the beginning of the study and 12 weeks after the trial. Data were entered into the computer using SPSS and analyzed by t-test. Results: FBS, lipid profile and blood pressure were not significantly different between the groups after 12 weeks (P > 0.05). No participant discontinued treatment due to adverse events. Conclusions: Vitamin D dietary supplementation is unlikely to reduce cardiovascular risk factors in post-menopausal women with vitamin D deficiency. PMID:25400681

  4. A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial

    PubMed Central

    Ypma, Paula F; van der Meer, Pieter F; Heddle, Nancy M; van Hilten, Joost A; Stijnen, Theo; Middelburg, Rutger A; Hervig, Tor; van der Bom, Johanna G; Brand, Anneke; Kerkhoffs, Jean-Louis H

    2016-01-01

    Introduction Patients with chemotherapy-induced thrombocytopaenia frequently experience minor and sometimes severe bleeding complications. Unrestrictive availability of safe and effective blood products is presumed by treating physicians as well as patients. Pathogen reduction technology potentially offers the opportunity to enhance safety by reducing bacterial and viral contamination of platelet products along with a potential reduction of alloimmunisation in patients receiving multiple platelet transfusions. Methods and analysis To test efficacy, a randomised, single-blinded, multicentre controlled trial was designed to evaluate clinical non-inferiority of pathogen-reduced platelet concentrates treated by the Mirasol system, compared with standard plasma-stored platelet concentrates using the percentage of patients with WHO grade ≥2 bleeding complications as the primary endpoint. The upper limit of the 95% CI of the non-inferiority margin was chosen to be a ≤12.5% increase in this percentage. Bleeding symptoms are actively monitored on a daily basis. The adjudication of the bleeding grade is performed by 3 adjudicators, blinded to the platelet product randomisation as well as by an automated computer algorithm. Interim analyses evaluating bleeding complications as well as serious adverse events are performed after each batch of 60 patients. The study started in 2010 and patients will be enrolled up to a maximum of 618 patients, depending on the results of consecutive interim analyses. A flexible stopping rule was designed allowing stopping for non-inferiority or futility. Besides analysing effects of pathogen reduction on clinical efficacy, the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) is designed to answer several other pending questions and translational issues related to bleeding and alloimmunisation, formulated as secondary and tertiary endpoints. Ethics and dissemination Ethics approval was obtained in all 3

  5. Cost-Effectiveness of One Year Dementia Follow-Up Care by Memory Clinics or General Practitioners: Economic Evaluation of a Randomised Controlled Trial

    PubMed Central

    Meeuwsen, Els; Melis, René; van der Aa, Geert; Golüke-Willemse, Gertie; de Leest, Benoit; van Raak, Frank; Schölzel-Dorenbos, Carla; Verheijen, Desiree; Verhey, Frans; Visser, Marieke; Wolfs, Claire; Adang, Eddy; Olde Rikkert, Marcel

    2013-01-01

    Objective To evaluate the cost-effectiveness of post-diagnosis dementia treatment and coordination of care by memory clinics compared to general practitioners’ care. Methods A multicentre randomised trial with 175 community dwelling patients newly diagnosed with mild to moderate dementia, and their informal caregivers, with twelve months’ follow-up. Cost-effectiveness was evaluated from a societal point of view and presented as incremental cost per quality adjusted life year. To establish cost-effectiveness, a cost-utility analysis was conducted using utilities based on the EQ-5D. Uncertainty surrounding the incremental cost-effectiveness ratio (difference in costs divided by difference in effects) was calculated by bootstrapping from the original data. Results Compared to general practitioners’ care, treatment by the memory clinics was on average €1024 (95% CI: −€7723 to €5674) cheaper, and showed a non-significant decrease of 0.025 (95% CI: −0.114 to 0.064) quality adjusted life years. The incremental cost-effectiveness point estimate from the bootstrap simulation was € 41 442 per QALY lost if one would use memory clinic care instead of general practitioner care. Conclusion No evidence was found that memory clinics were more cost-effective compared to general practitioners with regard to post-diagnosis treatment and coordination of care of patients with dementia in the first year after diagnosis. Trial Registration ClinicalTrials.gov NCT00554047 PMID:24282511

  6. 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

  7. Variation among institutional review boards in evaluating the design of a multicenter randomized trial

    PubMed Central

    Stark, AR; Tyson, JE; Hibberd, PL

    2010-01-01

    Objective The objective of the study was to examine the variation among institutional review boards (IRBs) in evaluation of the study design of a multicenter trial. Study Design We assessed the first written response of local IRBs to each site investigator for a multicenter trial of vitamin A supplementation in extremely low birth weight (ELBW) infants performed by the National Institute of Child Health and Human Development Neonatal Research Network. Each author of this paper independently reviewed and categorized IRB concerns as major, minor or none, according to the predefined criteria. Result Initially, 9 of 18 IRBs withheld approval because of at least one major concern. These concerns reflected difficulties in evaluating specific scientific issues for the design of the trial, including its justification, enrollment criteria, control and experimental therapies, co-interventions, toxicity assessment, outcome monitoring and informed consent. Conclusion The difficulty in assessing appropriate trial design for the specific hypothesis under investigation resulted in considerable variability in the evaluation by local IRBs. PMID:19798046

  8. [Intraoperative Evaluation of Total Knee Arthroplasty: Anatomic and Kinematic Assessment with Trial Components].

    PubMed

    von Roth, P; Pfitzner, T; Fuchs, M; Perka, C

    2015-06-01

    The intraoperative use of trial components in total knee arthroplasty (TKA) is of paramount importance to prevent inadequate ligament balance and to achieve optimal position of the definitive components. This review demonstrates an 8-step algorithm to assess the anatomy of the femoral, tibial and patellar component as well as the kinematics of the tibiofemoral and patellofemoral joints. Trial components allow an easy assessment of the anatomic fit of the final implants. Upon the trials insertion, bone coverage and the component overhang should be evaluated. The femoral rotation should be assessed using the transepicondylar axis and for the tibial component rotation assessment, the tibial tuberosity would be the most reliable bony landmark. Addressing the patella, sizing and bone coverage should be thoroughly evaluated. In order to restore physiological kinematics the remnants of the meniscus rim can be used to determine the correct reconstruction of the joint line. A tight extension gap results in limited extension, whereas a tight or unbalanced flexion gap leads to "booking" or "spin-out" of the inlay. The POLO test (pull-out, lift- off) allows an easy assessment of the posterior cruciate ligament tension and the size of the flexion gap as well. To prevent postoperative dislocation and overstuffing, specific tests for correct patellar positioning and tracking support should be performed. The anatomy and kinematics of total knee arthroplasty have to be evaluated by trial components on a routine basis before inserting the final implants in order to identify implant positioning errors and inadequate ligament balance. PMID:26114563

  9. The Prophylactic Effects of Zintoma and Ibuprofen on Post-endodontic Pain of Molars with Irreversible Pulpitis: A Randomized Clinical Trial

    PubMed Central

    Ramazani, Mohsen; Hamidi, Mahmoud Reza; Moghaddamnia, Ali Akbar; Ramazani, Nahid; Zarenejad, Nafiseh

    2013-01-01

    Introduction Post endodontic pain is often linked to the inflammatory process as well as additional central mechanisms. The purpose of the present double-blind randomized clinical trial study was to compare the prophylactic effects of a derivative of Zingiber Officinale, Zintoma, and Ibuprofen on post endodontic pain of molars with irreversible pulpitis. Materials and Methods The post endodontic pain of 72 enrolled patients suffering from irreversible pulpitis was assessed after prophylactic use of 400 mg Ibuprofen, 2 gr Zintoma and placebo. Using the Heft-Parker Visual Analogue Scale, the patients recorded their perceived pain before taking the medicament (baseline), immediately after and also at 4, 8, 12, 24, 48, and 72 h post one-visit endodontic treatment. The statistical analysis was done using Kruskal-Wallis, Mann-Whitney, and Freedman tests (P<0.05). Results At all times, there was significant difference between the Ibuprofen and Zintoma (P<0.05) and also between the Ibuprofen and placebo (P<0.05). However, there was no significant difference between Zintoma and the placebo in any of time intervals (P>0.05). No side effects were observed. Conclusion The obtained results of the trial revealed that prophylactic use of 2 gr Zintoma is not an effective pain relieving agent. PMID:23922575

  10. CA-125 can be part of the tumour evaluation criteria in ovarian cancer trials: experience of the GCIG CALYPSO trial

    PubMed Central

    Alexandre, J; Brown, C; Coeffic, D; Raban, N; Pfisterer, J; Mäenpää, J; Chalchal, H; Fitzharris, B; Volgger, B; Vergote, I; Pisano, C; Ferrero, A; Pujade-Lauraine, E

    2012-01-01

    Background: CA-125 as a tumour progression criterion in relapsing ovarian cancer (ROC) trials remains controversial. CALYPSO is a large randomised trial incorporating CA-125 (GCIG criteria) and symptomatic deterioration in addition to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (radiological) to determine progression. Methods: In all, 976 patients with platinum-sensitive ROC were randomised to carboplatin–paclitaxel (C-P) or carboplatin-pegylated liposomal doxorubicin (C-PLD). CT-scan and CA-125 were performed every 3 months until progression. Results: In all, 832 patients (85%) progressed, with 60% experiencing a first radiological progression, 10% symptomatic progression, and 28% CA-125 progression without evidence of radiological or symptomatic progression. The benefit of C-PLD vs C-P in progression-free survival was not influenced by type of first progression (hazard ratio 0.85 (95% confidence interval (CI): 0.66–1.10) and 0.84 (95% CI: 0.72–0.98) for CA-125 and RECIST, respectively). In patients with CA-125 first progression who subsequently progressed radiologically, a delay of 2.3 months was observed between the two progression types. After CA-125 first progression, median time to new treatment was 2.0 months. In all, 81%of the patients with CA-125 or radiological first progression and 60% with symptomatic first progression received subsequent treatment. Conclusion: CA-125 and radiological tests performed similarly in determining progression with C-PLD or C-P. Additional follow-up with CA-125 measurements was not associated with overtreatment. PMID:22240800

  11. Trial-based economic evaluations in occupational health: principles, methods, and recommendations.

    PubMed

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

    2014-06-01

    To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions. PMID:24854249

  12. Competency to stand trial evaluations in a multicultural population: Associations between psychiatric, demographic, and legal factors.

    PubMed

    Paradis, Cheryl M; Owen, Elizabeth; Solomon, Linda Z; Lane, Benjamin; Gulrajani, Chinmoy; Fullar, Michael; Perry, Alan; Rai, Sasha; Lavy, Tamar; McCullough, Gene

    2016-01-01

    Data were examined from an archival sample of Competency to Stand Trial (CST) reports of 200 consecutive New York City pre-trial defendants evaluated over a five-month period. Approximately a fourth of defendants in the present study were immigrants; many required the assistance of interpreters. The examiners conducting the CST evaluation diagnosed approximately half of the defendants with a primary diagnosis of a psychotic disorder and deemed over half not competent. Examiners reached the same conclusion about competency in 96% of cases, about the presence of a psychotic disorder in 91% of cases, and affective disorder in 85% of cases. No significant differences between psychologists and psychiatrists were found for rates of competency/incompetency opinions. Compared to those deemed competent, defendants deemed not competent had significantly higher rates of prior psychiatric hospitalization and diagnosis of psychotic illness at the time of the CST evaluation but lower rates of reported substance abuse. PMID:27085728

  13. Can Pacing Be Regulated by Post-Activation Potentiation? Insights from a Self-Paced 30 km Trial in Half-Marathon Runners

    PubMed Central

    Del Rosso, Sebastián; Barros, Edilberto; Tonello, Laís; Oliveira-Silva, Iransé; Behm, David G.; Foster, Carl; Boullosa, Daniel A.

    2016-01-01

    Purpose Given the co-existence of post-activation potentiation (PAP) and fatigue within muscle, it is not known whether PAP could influence performance and pacing during distance running by moderating fatigue. The aim of this study was to assess the influence of PAP on pacing, jumping and other physiological measures during a self-paced 30 km trial. Methods Eleven male endurance-trained runners (half-marathon runners) volunteered to participate in this study. Runners participated in a multi-stage 30 km trial. Before the trial started, determination of baseline blood lactate (bLa) and countermovement jump (CMJ) height was performed. The self-paced 30 km trial consisted of 6 × 5 km splits. At the end of each 5 km split (60 s break), data on time to complete the split, CMJ height, Rating of Perceived Exertion (RPE) and blood lactate were collected while heart rate was continuously monitored. Results There was a significant decrease in speed (e.g. positive pacing strategy after the 4th split, p<0.05) with a progressive increase in RPE throughout the trial. Compared with baseline, CMJ height was significantly (p<0.05) greater than baseline and was maintained until the end of the trial with an increase after the 5th split, concomitant with a significant reduction in speed and an increase in RPE. Significant correlations were found between ΔCMJ and ΔSPEED (r = 0.77 to 0.87, p<0.05) at different time points as well as between RPE and speed (r = -0.61 to -0.82, p<0.05). Conclusion Our results indicates that fatigue and potentiation co-exist during long lasting endurance events, and that the observed increase in jump performance towards the end of the trial could be reflecting a greater potentiation potentially perhaps counteracting the effects of fatigue and preventing further reductions in speed. PMID:26934357

  14. The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project Study: protocol for a randomised controlled trial comparing methadone and buprenorphine for opiate detoxification

    PubMed Central

    Sheard, Laura; Wright, Nat MJ; Adams, Clive E; Bound, Nicole; Rushforth, Bruno; Hart, Roger; Tompkins, Charlotte NE

    2009-01-01

    Background In the United Kingdom (UK), there is an extensive market for the class 'A' drug heroin and many heroin users spend time in prison. People addicted to heroin often require prescribed medication when attempting to cease their drug use. The most commonly used detoxification agents in UK prisons are currently buprenorphine and methadone, both are recommended by national clinical guidelines. However, these agents have never been compared for opiate detoxification in the prison estate and there is a general paucity of research evaluating the most effective treatment for opiate detoxification in prisons. This study seeks to address this paucity by evaluating the most routinely used interventions amongst drug users within UK prisons. Methods/Design This study uses randomised controlled trial methodology to compare the open use of buprenorphine and methadone for opiate detoxification, given in the context of routine care, within three UK prisons. Prisoners who are eligible and give informed consent will be entered into the trial. The primary outcome will be abstinence status eight days after detoxification, as determined by a urine test. Secondary outcomes will be recorded during the detoxification and then at one, three and six months post-detoxification. Trial registration Current Controlled Trials ISRCTN58823759 PMID:19602218

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

    PubMed Central

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

    2016-01-01

    Purpose This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. Materials and Methods Asymptomatic or mildly symptomatic chemotherapy-naive men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50% decline), and time to skeletal-related event. Results Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95% confidence interval) for enzalutamide versus placebo were 0.23 (0.02–2.24) for centrally assessed rPFS, 0.77 (0.28–2.15) for OS, 0.21 (0.08–0.51) for time to chemotherapy, and 0.31 (0.17–0.56) for time to PSA progression. A PSA response was observed in 70.0% of enzalutamide-treated and 10.5% of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33% of enzalutamide-treated and 11% of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97–1.10). Conclusions In Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population (ClinicalTrials.gov Identifier: NCT01212991). PMID:27195316

  16. Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial

    PubMed Central

    Escontrela Rodriguez, Blanca; Planas Roca, Antonio; Martínez Ruiz, Alberto

    2016-01-01

    Background Non-steroidal anti-inflammatory drugs are often used as components of multimodal therapy for postoperative pain management, but their use is currently limited by its side effects. The specific objective of this study was to evaluate the efficacy and safety of a new formulation of intravenous (IV) ibuprofen for the management of postoperative pain in a European population. Methods and Findings A total of 206 patients from both abdominal and orthopedic surgery, were randomly assigned in 1:1 ratio to receive 800 mg IV-ibuprofen or placebo every 6 hours; all patients had morphine access through a patient controlled analgesia pump. The primary outcome measure was median morphine consumption within the first 24 hours following surgery. The mean±SEM of morphine requirements was reduced from 29,8±5,25 mg to 14,22±3,23 mg (p = 0,015) and resulted in a decrease in pain at rest (p = 0,02) measured by Visual Analog Scale (VAS) from mean±SEM 3.34±0,35 to 0.86±0.24, and also in pain during movement (p = 0,02) from 4.32±0,36 to 1.90±0,30 in the ibuprofen treatment arm; while in the placebo group VAS score at rest ranged from 4.68±0,40 to 2.12±0,42 and during movement from 5.66±0,42 to 3.38±0,44. Similar treatment-emergent adverse events occurred across both study groups and there was no difference in the overall incidence of these events. Conclusions Perioperative administration of IV-Ibuprofen 800 mg every 6 hours in abdominal surgery patient’s decreases morphine requirements and pain score. Furthermore IV-Ibuprofen was safe and well tolerate. Consequently we consider appropriate that protocols for management of postoperative pain include IV-Ibuprofen 800 mg every 6 hours as an option to offer patients an analgesic benefit while reducing the potentially risks associated with morphine consumption. Trial Registration EU Clinical Trials Register 2011-005007-33 PMID:27152748

  17. [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. PMID:25532372

  18. 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)

  19. Do Course Evaluations Truly Reflect Student Learning? Evidence from an Objectively Graded Post-Test

    ERIC Educational Resources Information Center

    Beleche, Trinidad; Fairris, David; Marks, Mindy

    2012-01-01

    It is difficult to assess the extent to which course evaluations reflect how much students truly learn from a course because valid measures of learning are rarely available. This paper makes use of a unique setting in which students take a common, high-stakes post-test which is centrally graded and serves as the basis for capturing actual student…

  20. 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…

  1. EVALUATION OF AN AUTOMATED SORTING PROCESS FOR POST-CONSUMER MIXED PLASTIC CONTAINERS

    EPA Science Inventory

    The report is a detailed evaluation of a pilot-scale automated sorting system for mixed post-consumer plastic containers developed by Rutgers University Center for Plastics Recycling Research (CPRR). he five bottle types considered were natural high density polyethylene (HDPE), p...

  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. Quality and Reporting of Cluster Randomized Controlled Trials Evaluating Occupational Therapy Interventions

    PubMed Central

    Tokolahi, Ema; Hocking, Clare; Kersten, Paula; Vandal, Alain C.

    2015-01-01

    Growing use of cluster randomized control trials (RCTs) in health care research requires careful attention to study designs, with implications for the development of an evidence base for practice. The objective of this study is to investigate the characteristics, quality, and reporting of cluster RCTs evaluating occupational therapy interventions to inform future research design. An extensive search of cluster RCTs evaluating occupational therapy was conducted in several databases. Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomized, and five reported intercluster correlation coefficients (50%): Protocols had higher compliance. Risk of bias was most evident in unblinding of participants. Statistician involvement was associated with improved trial quality and reporting. Quality of cluster RCTs of occupational therapy interventions is comparable with those from other areas of health research and needs improvement. PMID:27504689

  4. The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) prisons project pilot study: protocol for a randomised controlled trial comparing dihydrocodeine and buprenorphine for opiate detoxification

    PubMed Central

    Sheard, Laura; Adams, Clive E; Wright, Nat MJ; El-Sayeh, Hany; Dalton, Richard; Tompkins, Charlotte NE

    2007-01-01

    Background In the United Kingdom (UK), there is an extensive market for the class 'A' drug heroin. Many heroin users spend time in prison. People addicted to heroin often require prescribed medication when attempting to cease their drug use. The most commonly used detoxification agents in UK prisons are buprenorphine, dihydrocodeine and methadone. However, national guidelines do not state a detoxification drug of choice. Indeed, there is a paucity of research evaluating the most effective treatment for opiate detoxification in prisons. This study seeks to address the paucity by evaluating routinely used interventions amongst drug using prisoners within UK prisons. Methods/Design The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Pilot Study will use randomised controlled trial methodology to compare the open use of buprenorphine and dihydrocodeine for opiate detoxification, given in the context of routine care, within HMP Leeds. Prisoners who are eligible and give informed consent will be entered into the trial. The primary outcome measure will be abstinence status at five days post detoxification, as determined by a urine test. Secondary outcomes during the detoxification and then at one, three and six months post detoxification will be recorded. PMID:17210080

  5. Scientific standards for human intervention trials evaluating health benefits of foods, and their application to infants, children and adolescents.

    PubMed

    Woodside, Jayne V; Koletzko, Berthold V; Patterson, Chris C; Welch, Robert W

    2013-01-01

    Associations between the consumption of particular foods and health outcomes may be indicated by observational studies. However, intervention trials that evaluate the health benefits of foods provide the strongest evidence to support dietary recommendations for health. Thus, it is important that these trials are carried out safely, and to high scientific standards. Accepted standards for the reporting of the health benefits of pharmaceutical and other medical interventions have been provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. However, there are no generally accepted standards for trials to evaluate the health benefits of foods. Trials with foods differ from medical trials in issues related to safety, ethics, research governance and practical implementation. Furthermore, these important issues can deter the conduct of both medical and nutrition trials in infants, children and adolescents. This paper provides standards for the planning, design, conduct, statistical analysis and interpretation of human intervention trials to evaluate the health benefits of foods that are based on the CONSORT guidelines, and outlines the key issues that need to be addressed in trials in participants in the paediatric age range. PMID:24029783

  6. 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

  7. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    PubMed

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media. PMID:27220801

  8. Statistical evaluation of surrogate endpoints with examples from cancer clinical trials.

    PubMed

    Buyse, Marc; Molenberghs, Geert; Paoletti, Xavier; Oba, Koji; Alonso, Ariel; Van der Elst, Wim; Burzykowski, Tomasz

    2016-01-01

    A surrogate endpoint is intended to replace a clinical endpoint for the evaluation of new treatments when it can be measured more cheaply, more conveniently, more frequently, or earlier than that clinical endpoint. A surrogate endpoint is expected to predict clinical benefit, harm, or lack of these. Besides the biological plausibility of a surrogate, a quantitative assessment of the strength of evidence for surrogacy requires the demonstration of the prognostic value of the surrogate for the clinical outcome, and evidence that treatment effects on the surrogate reliably predict treatment effects on the clinical outcome. We focus on these two conditions, and outline the statistical approaches that have been proposed to assess the extent to which these conditions are fulfilled. When data are available from a single trial, one can assess the "individual level association" between the surrogate and the true endpoint. When data are available from several trials, one can additionally assess the "trial level association" between the treatment effect on the surrogate and the treatment effect on the true endpoint. In the latter case, the "surrogate threshold effect" can be estimated as the minimum effect on the surrogate endpoint that predicts a statistically significant effect on the clinical endpoint. All these concepts are discussed in the context of randomized clinical trials in oncology, and illustrated with two meta-analyses in gastric cancer. PMID:25682941

  9. Bihemispheric Motor Cortex Transcranial Direct Current Stimulation Improves Force Steadiness in Post-Stroke Hemiparetic Patients: A Randomized Crossover Controlled Trial

    PubMed Central

    Montenegro, Rafael A.; Midgley, Adrian; Massaferri, Renato; Bernardes, Wendell; Okano, Alexandre H.; Farinatti, Paulo

    2016-01-01

    Post-stroke patients usually exhibit reduced peak muscular torque (PT) and/or force steadiness during submaximal exercise. Brain stimulation techniques have been proposed to improve neural plasticity and help to restore motor performance in post-stroke patients. The present study compared the effects of bihemispheric motor cortex transcranial direct current stimulation (tDCS) on PT and force steadiness during maximal and submaximal resistance exercise performed by post-stroke patients vs. healthy controls. A double-blind randomized crossover controlled trial (identification number: TCTR20151112001; URL: http://www.clinicaltrials.in.th/) was conducted involving nine healthy and 10 post-stroke hemiparetic individuals who received either tDCS (2 mA) or sham stimulus upon the motor cortex for 20 min. PT and force steadiness (reflected by the coefficient of variation (CV) of muscular torque) were assessed during unilateral knee extension and flexion at maximal and submaximal workloads (1 set of 3 repetitions at 100% PT and 2 sets of 10 repetitions at 50% PT, respectively). No significant change in PT was observed in post-stroke and healthy subjects. Force steadiness during knee extension (~25–35%, P < 0.001) and flexion (~22–33%, P < 0.001) improved after tDCS compared to the sham condition in post-stroke patients, but improved only during knee extension (~13–27%, P < 0.001) in healthy controls. These results suggest that tDCS may improve force steadiness, but not PT in post-stroke hemiparetic patients, which might be relevant in the context of motor rehabilitation programs. PMID:27601988

  10. Bihemispheric Motor Cortex Transcranial Direct Current Stimulation Improves Force Steadiness in Post-Stroke Hemiparetic Patients: A Randomized Crossover Controlled Trial.

    PubMed

    Montenegro, Rafael A; Midgley, Adrian; Massaferri, Renato; Bernardes, Wendell; Okano, Alexandre H; Farinatti, Paulo

    2016-01-01

    Post-stroke patients usually exhibit reduced peak muscular torque (PT) and/or force steadiness during submaximal exercise. Brain stimulation techniques have been proposed to improve neural plasticity and help to restore motor performance in post-stroke patients. The present study compared the effects of bihemispheric motor cortex transcranial direct current stimulation (tDCS) on PT and force steadiness during maximal and submaximal resistance exercise performed by post-stroke patients vs. healthy controls. A double-blind randomized crossover controlled trial (identification number: TCTR20151112001; URL: http://www.clinicaltrials.in.th/) was conducted involving nine healthy and 10 post-stroke hemiparetic individuals who received either tDCS (2 mA) or sham stimulus upon the motor cortex for 20 min. PT and force steadiness (reflected by the coefficient of variation (CV) of muscular torque) were assessed during unilateral knee extension and flexion at maximal and submaximal workloads (1 set of 3 repetitions at 100% PT and 2 sets of 10 repetitions at 50% PT, respectively). No significant change in PT was observed in post-stroke and healthy subjects. Force steadiness during knee extension (~25-35%, P < 0.001) and flexion (~22-33%, P < 0.001) improved after tDCS compared to the sham condition in post-stroke patients, but improved only during knee extension (~13-27%, P < 0.001) in healthy controls. These results suggest that tDCS may improve force steadiness, but not PT in post-stroke hemiparetic patients, which might be relevant in the context of motor rehabilitation programs. PMID:27601988

  11. Post-Dilatation Intravascular Brachytherapy Trials on Hypercholesterolemic Rabbits Using {sup 32}P-Phosphate Solutions in Angioplasty Balloons

    SciTech Connect

    Walichiewicz, Piotr Wilczek, Krzysztof; Petelenz, Barbara; Jachec, Wojciech; Jochem, Jerzy; Tomasik, Andrzej; Bilski, Pawel; Gaca, Pawel; Banaszczuk, Joanna; Ihnatowicz, Jerzy; Wodniecki, Jan

    2004-01-15

    Response of peripheral arteries to post-dilatation intravascular brachytherapy (IVBT) using {sup 32}P liquid sources was studied in a rabbit model. The applied sources were angioplasty balloons filled with aqueous solutions of Na{sub 2}H{sup 32}PO{sub 4}, NaCl and iodinated contrast. Dose distribution was calibrated by thermoluminescence dosimetry. The uncertainty of in vitro determinations of the activity-dose dependence was {+-} 15-30%. The animal experiments were performed on rabbits with induced hypercholesterolemia. The {sup 32}P sources were introduced into a randomly chosen (left or right) iliac artery, immediately after balloon injury. Due to the low specific activity of the applied sources, the estimated 7-49 Gy doses on the internal artery surface required 30-100 min irradiations. A symmetric, balloon-occluded but non-irradiated artery of the same animal served as control. Radiation effects were evaluated by comparing the thicknesses of various components of irradiated versus untreated artery walls of each animal. The treatment was well tolerated by the animals. The effects of various dose ranges could be distinguished although differences in individual biological reactions were large. Only the 49 Gy dose at 'zero' distance (16 Gy at 1.0 mm from the balloon surface) reduced hypertrophy in every active layer of the artery wall. The cross-sectional intimal thicknesses after 7, 12, 38 and 49 Gy doses were 0.277, 0.219, 0.357 and 0.196 mm{sup 2} respectively, versus 0.114, 0.155, 0.421 and 0.256 mm{sup 2} in controls (p < 0.05). The lowest radiation dose on the intima induced the opposite effect. Edge intimal hyperplasia was not avoided, which agrees with other reports. The edge restenosis and the variability of individual response to identical treatment conditions must be considered as limitations of the post-dilatation IVBT method. Only application of highest irradiation doses was effective. The irradiation dose should be planned and calculated for

  12. Results availability for analgesic device, complex regional pain syndrome, and post-stroke pain trials: comparing the RReADS, RReACT, and RReMiT databases

    PubMed Central

    Dufka, Faustine L.; Munch, Troels; Dworkin, Robert H.; Rowbotham, Michael C.

    2015-01-01

    Abstract Evidence-based medicine rests on the assumption that treatment recommendations are robust, free from bias, and include results of all randomized clinical trials. The Repository of Registered Analgesic Clinical Trials search and analysis methodology was applied to create databases of complex regional pain syndrome (CRPS) and central post-stroke pain (CPSP) trials and adapted to create the Repository of Registered Analgesic Device Studies databases for trials of spinal cord stimulation (SCS), repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (tDCS). We identified 34 CRPS trials, 18 CPSP trials, 72 trials of SCS, and 92 trials of rTMS/tDCS. Irrespective of time since study completion, 45% of eligible CRPS and CPSP trials and 46% of eligible SCS and rTMS/tDCS trials had available results (peer-reviewed literature, results entered on registry, or gray literature); peer-reviewed publications could be found for 38% and 39%, respectively. Examining almost 1000 trials across a spectrum of painful disorders (fibromyalgia, diabetic painful neuropathy, post-herpetic neuralgia, migraine, CRPS, CPSP) and types of treatment, no single study characteristic consistently predicts unavailability of results. Results availability is higher 12 months after study completion but remains below 60% for peer-reviewed publications. Recommendations to increase results availability include supporting organizations advocating for transparency, enforcing existing results reporting regulations, enabling all primary registries to post results, stating trial registration numbers in all publication abstracts, and reducing barriers to publishing “negative” trials. For all diseases and treatment modalities, evidence-based medicine must rigorously adjust for the sheer magnitude of missing results in formulating treatment recommendations. PMID:25599303

  13. An Evaluation of a Two Week Teaching Trial Using Interactive Video Technology: Perceptions of Students and Staff.

    ERIC Educational Resources Information Center

    Baker, R. A.; Hansford, B. C.

    This report is concerned with an evaluation of a 2-week teaching trial in 1989 that utilized compressed data--interactive video technology. The trial was a collaborative venture of the University of New England (UNE), TELECOM, the Department of Education, Employment and Training (DEET), and SONY. In general, the University of New England supplied…

  14. Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial

    PubMed Central

    Prabhakar, A. R.; Karuna, Y. M.; Yavagal, C.; Deepak, B. M.

    2015-01-01

    Context: The survival of atraumatic restorative treatment (ART) restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. Aims: To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Settings and Designs: Experimental, in vivo intergroup split mouth, randomized clinical trial. Subjects and Methods: The study included Group I (Control), Group II (A. vera) and Group III (propolis). Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Statistical Analysis Used: Repeated measures of analysis of variance (ANOVA) with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. Results: In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Conclusions: Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry. PMID:25821369

  15. Effect of Karamardādi Yoga versus diclofenac sodium in post-operative pain management: A randomized comparative clinical trial

    PubMed Central

    Hegana, Rahul; Toshikhane, Hemant Devaraj; Toshikhane, Sangeeta; Amin, Hetal

    2016-01-01

    Introduction: Post-operative pain is Nociceptive i.e., anticipated unavoidable physiological pain which is caused due to tissue trauma. Drugs such as NSAIDs (Non Steroidal Anti Inflammatory Drugs) and Opioids are used for post-operative pain management but are associated with their own drawbacks. Karamardādi Yoga has been in use in Ayurvedic practice for analgesia. It is known to relieve pain and can be used to supplement anaesthesia and also get rid of adverse effect of modern analgesic drugs. Aims and Objective: To study the comparative effect of Karamardādi Yoga and Diclofenac sodium in post-operative pain management. Materials and Methods: Randomized clinical trial with Group A (Control Group: Tab Diclofenac sodium 50 mg as a single dose) and Group B (Trial Group: Cap Karamardādi Yoga 500 mg as a single dose). Those who had undergone haemorrhoidectomy operation under local anaesthesia were selected as per inclusion criteria. Vitals, desirable effect and undesirable effect, total surgical time, requirement of 1st dose of analgesic, requirement of rescue analgesic and pain determined by VAS (Visual Analog Scale) were the assessment criteria and were observed and recorded. Results: Karamardādi Yoga does not show any undesirable or serious ill effects and altered values of vitals as per statistical analysis. As per VAS scale, pain felt by Trial group was earlier than control group. Conclusions: Karamardādi Yoga has analgesic property but its analgesic property and pain threshold capacity is lesser than those of Diclofenac sodium. PMID:27621519

  16. An evaluation of programmed treatment-integrity errors during discrete-trial instruction.

    PubMed

    Carroll, Regina A; Kodak, Tiffany; Fisher, Wayne W

    2013-01-01

    This study evaluated the effects of programmed treatment-integrity errors on skill acquisition for children with an autism spectrum disorder (ASD) during discrete-trial instruction (DTI). In Study 1, we identified common treatment-integrity errors that occur during academic instruction in schools. In Study 2, we simultaneously manipulated 3 integrity errors during DTI. In Study 3, we evaluated the effects of each of the 3 integrity errors separately on skill acquisition during DTI. Results showed that participants either demonstrated slower skill acquisition or did not acquire the target skills when instruction included treatment-integrity errors. PMID:24114154

  17. [Evaluation of the biological control potential of Metarhizium anisopliae toward Boophilus microplus in pen trials].

    PubMed

    Bahiense, Thiago C; Fernandes, Everton K K; Angelo, Isabele da C; Perinotto, Wendell M de S; Bittencourt, Vãnia R E P

    2007-01-01

    The aim of the present study was to evaluate the capacity of the fungus Metarhizium anisopliae to control Boophilus microplus tick in pen trials. Infested calves were held in individual pen and treated with fungus suspension through aspersion bath. The results were evaluated based on ticks' mortality rate for 28 days after treatment, and on the analysis of biology of tick's samples which were transferred to an incubation chamber. It was reported 33% of mortality during the total period analyzed, and the production of eggs and nutritional rates were decreased only for a short period after treatment. PMID:18373901

  18. The effect of macrobiotic Ma-Pi 2 diet on systemic inflammation in patients with type 2 diabetes: a post hoc analysis of the MADIAB trial

    PubMed Central

    Soare, Andreea; Del Toro, Rossella; Roncella, Elena; Khazrai, Yeganeh Manon; Angeletti, Silvia; Dugo, Laura; Fallucca, Sara; Fontana, Lucia; Altomare, Maria; Formisano, Valeria; Capata, Francesca; Gesuita, Rosaria; Manfrini, Silvia; Fallucca, Francesco; Pianesi, Mario; Pozzilli, Paolo

    2015-01-01

    Introduction Current guidelines for the management of type 2 diabetes (T2D) emphasize diet as essential therapy. However, the effect of diet on systemic inflammation remains unclear. We investigated the effects of consuming a macrobiotic Ma-Pi 2 diet versus a standard recommended diet (control diet) on markers of inflammation in patients with T2D. Methods This was a post hoc analysis of the MADIAB trial, a 21-day randomized controlled trial conducted in 51 patients (25 males and 26 females) with T2D. Patients were randomized 1:1 to the Ma-Pi 2 macrobiotic diet or a control diet based on dietary guidelines for T2D. Biological antioxidant potential of plasma and circulating levels of high-sensitivity C reactive protein, interleukin-6, tumor necrosis factor-α, and insulin-like growth factor-1 were assessed. Results After 21 days on the Ma-Pi 2 or control diet, markers of inflammation were reduced in both groups. The antioxidant potential of plasma improved significantly in the Ma-Pi group. A significant reduction in insulin growth factor-1 was observed in the Ma-Pi group versus control group (p<0.001). Conclusions Findings of this post hoc analysis demonstrated that the Ma-Pi 2 diet is a safe dietary strategy to reduce levels of the markers of insulin resistance and inflammation, compared with baseline values, in the short term. Furthermore, the Ma-Pi 2 diet was superior to the control diet in reducing insulin growth factor-1 and may be beneficial for patients with T2D. Trial registration number Current Controlled Trials ISRCTN10467793. PMID:25852946

  19. Fourth Generation Educational Evaluation: The Impact of a Post-Modern Paradigm on School Based Evaluation.

    ERIC Educational Resources Information Center

    Russell, Neil; Willinsky, John

    1997-01-01

    Postmodern approaches to school-level evaluation by building on the fourth-generation evaluation model developed by E. Guba and Y. Lincoln are suggested. It is argued that this conceptualization of evaluation has particular relevance for development of alternative evaluation practices among stakeholders that can improve the use of evaluation…

  20. Effects of aggressive cholesterol lowering and low-dose anticoagulation on clinical and angiographic outcomes in patients with diabetes: the Post Coronary Artery Bypass Graft Trial.

    PubMed

    Hoogwerf, B J; Waness, A; Cressman, M; Canner, J; Campeau, L; Domanski, M; Geller, N; Herd, A; Hickey, A; Hunninghake, D B; Knatterud, G L; White, C

    1999-06-01

    Diabetic patients have greater risk for coronary heart disease (CHD) events after coronary artery bypass graft (CABG) surgery than nondiabetic patients. The Post CABG trial studied the effects of aggressive cholesterol lowering and low-dose anticoagulation in diabetic patients compared with nondiabetic patients. A double-blind, randomized clinical trial in 1,351 patients (1-11 years after CABG), the Post CABG trial consisted of two interventions (aggressive cholesterol-lowering versus moderate lowering and low-dose warfarin versus placebo) on angiographic end points. Angiographic changes in saphenous vein graft conduits 4.3 years after entry were compared in 116 diabetic and 1,235 nondiabetic patients. Seven clinical centers participated in the trial, as well as the National Institutes of Health project office (National Heart, Lung, and Blood Institute), the coordinating center (Maryland Medical Research Institute), and the Angiogram Reading Center (University of Minnesota). Baseline characteristics of the diabetic patients differed from the nondiabetic patients in the following ways: percentage of women participants, 15 vs. 7%, P = 0.002; mean baseline weight, 87.4 vs. 82.8 kg, P = 0.006; mean BMI, 29.5 vs. 27.6 kg/m2, P = 0.0002; mean systolic blood pressure, 141.7 vs. 133.6, P < 0.0001; mean triglyceride concentrations, 2.09 vs. 1.77 mmol/l, P < 0.0001; and mean HDL cholesterol concentrations, 0.93 vs. 1.02 mmol, P = 0.0001. The percentage of clinical events was higher in diabetic than nondiabetic patients (20.6 vs. 13.4, P = 0.033) and angiographic outcomes were not different. The benefits of aggressive cholesterol lowering were comparable in diabetic and nondiabetic patients for the angiographic end points. Warfarin use was not associated with clinical or angiographic benefit. Diabetic patients in the Post CABG trial had more CHD risk factors at study entry and higher clinical event rates during the study than nondiabetic patients. The benefits of aggressive

  1. Double-blind controlled trial to compare anti-inflammatory effects of tolmetin 2%, prednisolone 0.5%, and placebo in post-cataract extraction eyes.

    PubMed Central

    Smerdon, D L; Hung, S O; Akingbehin, T

    1986-01-01

    This paper compares the efficacy of tolmetin, prednisolone, and placebo (vehicle only) in controlling post-cataract extraction inflammation in a double-blind trial involving 120 patients. Seventeen patients were excluded from analysis. The results of the 103 patients analysed showed that 94% of the prednisolone treated group was judged to have been successfully treated as compared with 53% of the tolmetin treated group and 46% of the vehicle treated group. The differences between the prednisolone treated group and the other two groups were statistically significant (p less than 0.001). No statistical significance was found between the tolmetin and vehicle groups. PMID:3535872

  2. Patient and carer experience of hospital-based rehabilitation from intensive care to hospital discharge: mixed methods process evaluation of the RECOVER randomised clinical trial

    PubMed Central

    Ramsay, Pam; Huby, Guro; Merriweather, Judith; Salisbury, Lisa; Rattray, Janice; Griffith, David; Walsh, Timothy

    2016-01-01

    Objectives To explore and compare patient/carer experiences of rehabilitation in the intervention and usual care arms of the RECOVER trial (ISRCTN09412438); a randomised controlled trial of a complex intervention of post-intensive care unit (ICU) acute hospital-based rehabilitation following critical illness. Design Mixed methods process evaluation including comparison of patients' and carers' experience of usual care versus the complex intervention. We integrated and compared quantitative data from a patient experience questionnaire (PEQ) with qualitative data from focus groups with patients and carers. Setting Two university-affiliated hospitals in Scotland. Participants 240 patients discharged from ICU who required ≥48 hours of mechanical ventilation were randomised into the trial (120 per trial arm). Exclusion criteria comprised: primary neurologic diagnosis, palliative care, current/planned home ventilation and age <18 years. 182 patients completed the PEQ at 3 months postrandomisation. 22 participants (14 patients and 8 carers) took part in focus groups (2 per trial group) at >3 months postrandomisation. Interventions A complex intervention of post-ICU acute hospital rehabilitation, comprising enhanced physiotherapy, nutritional care and information provision, case-managed by dedicated rehabilitation assistants (RAs) working within existing ward-based clinical teams, delivered between ICU discharge and hospital discharge. Comparator was usual care. Outcome measures A novel PEQ capturing patient-reported aspects of quality care. Results The PEQ revealed statistically significant between-group differences across 4 key intervention components: physiotherapy (p=0.039), nutritional care (p=0.038), case management (p=0.045) and information provision (p<0.001), suggesting greater patient satisfaction in the intervention group. Focus group data strongly supported and helped explain these findings. Specifically, case management by dedicated RAs facilitated

  3. Optical Coherence Tomography Evaluation in the Multicenter Uveitis Steroid Treatment (MUST) Trial

    PubMed Central

    Domalpally, Amitha; Altaweel, Michael M.; Kempen, John H.; Myers, Dawn; Davis, Janet L; Foster, C Stephen; Latkany, Paul; Srivastava, Sunil K.; Stawell, Richard J.; Holbrook, Janet T.

    2013-01-01

    Purpose To describe the evaluation of optical coherence tomography (OCT) scans in the Muliticenter Uveitis Steroid Treatment (MUST) trial and report baseline OCT features of enrolled participants. Methods Time domain OCTs acquired by certified photographers using a standardized scan protocol were evaluated at a Reading Center. Accuracy of retinal thickness data was confirmed with quality evaluation and caliper measurement of centerpoint thickness (CPT) was performed when unreliable. Morphological evaluation included cysts, subretinal fluid,epiretinal membranes (ERMs),and vitreomacular traction. Results Of the 453 OCTs evaluated, automated retinal thickness was accurate in 69.5% of scans, caliper measurement was performed in 26%,and 4% were ungradable. Intraclass correlation was 0.98 for reproducibility of caliper measurement. Macular edema (centerpoint thickness ≥ 240um) was present in 36%. Cysts were present in 36.6% of scans and ERMs in 27.8%, predominantly central. Intergrader agreement ranged from 78 − 82% for morphological features. Conclusion Retinal thickness data can be retrieved in a majority of OCT scans in clinical trial submissions for uveitis studies. Small cysts and ERMs involving the center are common in intermediate and posterior/panuveitis requiring systemic corticosteroid therapy. PMID:23163490

  4. A Community Consultation Survey to Evaluate Support for and Success of the IMMEDIATE Trial

    PubMed Central

    Beshansky, Joni R.; Sheehan, Patricia R.; Klima, Kenneth J.; Hadar, Nira; Vickery, Ellen M.; Selker, Harry P.

    2014-01-01

    Background The IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care) Trial, a randomized controlled double-blind clinical effectiveness trial of glucose-insulin-potassium (GIK) administered in ambulances in the out-of-hospital setting, used the Exception from Informed Consent Requirements (EFIC) for Emergency Research under Title 21 of the Code of Federal Regulations. EFIC requirements include community consultation that typically involves using a variety of communication methods and venues to inform the public of the research and to receive their feedback. Although not the primary purpose of the community consultation process, a common concern to research sponsors, staff, and institutional review boards (IRBs) is whether there will be a sufficient number of participants to justify mounting a study in their community. Information from community consultation regarding the community acceptance might inform this question. . Purpose We evaluated the utility of telephone survey data done as part of the EFIC process as a way to project the ultimate rate of trial participant enrollment. Methods A telephone survey community consultation process was undertaken in nine communities planning to be IMMEDIATE Trial sites using a representative sampling of the target population in the areas covered by participating emergency medical service (EMS) agencies. Survey respondents were read a description of the planned study and its informed consent approach that included the option for patients to decline participation in the trial while being transported for acute care in an ambulance. Survey respondents were then asked whether they would object to participating in the study. At the conclusion of actual trial enrollment, the Coordinating Center compared the survey results with the actual rates of enrollment at each site. Results Approximately 200 (range 200 - 271) respondents completed the survey in each of the study

  5. Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer

    PubMed Central

    Kobayashi, Naomi; Bonnard, Eric; Charbonnier, Colette; Yamamichi, Junta; Mizobe, Hideaki; Kimura, Shinya

    2015-01-01

    Background Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. Purpose To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. Material and Methods Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. Results KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. Conclusion The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites. PMID:26668754

  6. Inter-trial analysis of post-movement Beta activities in EEG signals using multivariate empirical mode decomposition.

    PubMed

    Chang, Hsiang-Chih; Lee, Po-Lei; Lo, Men-Tzung; Wu, Yu-Te; Wang, Kuo-Wei; Lan, Gong-Yau

    2013-07-01

    Event-related desynchronization/synchronization (ERD/ERS) is a technique to quantify subject's nonphase-locked neural activities underlying specific frequency bands, reactive to external/internal stimulus. However, conventional ERD/ERS studies usually utilize fixed frequency band determined from one or few channels to filter whole-head EEG/MEG data, which may inevitably include task-unrelated signals and result in underestimation of reactive oscillatory activities in multichannel studies. In this study, we adopted multivariate empirical mode decomposition (MEMD) to extract beta-related oscillatory activities in performing self-paced right and left index-finger lifting tasks. The MEMD extracts common modes from all channels in same-index intrinsic mode functions (IMFs) which allows the temporal-frequency features among different channels can be compared in each subband. The beta-band oscillatory activities were further bandpass filtered within trial-specific beta bands determined from sensorimotor-related channels (C3 and C4), and then rectified using amplitude modulation method to detect trial-by-trial beta rebound (BR) values in ERS time courses. The validity of the MEMD approach in BR values extraction has been demonstrated in multichannel EEG study which showed larger BR values than conventional ERS technique. The MEMD-based method enables the trial-by-trial extraction of sensorimotor oscillatory activities which might allow the exploration of subtle brain dynamics in future studies. PMID:23661320

  7. 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

  8. Trial design for evaluating novel treatments during an outbreak of an infectious disease.

    PubMed

    Whitehead, John; Olliaro, Piero; Lang, Trudie; Horby, Peter

    2016-02-01

    Tragically, the outbreak of Ebola that started in West Africa in 2014 has been far more extensive and damaging than any previous outbreaks. The duration of the outbreak has, for the first time, allowed the clinical evaluation of Ebola treatments. This article discusses the designs used for two such clinical trials which have recruited patients in Liberia and Sierra Leone. General principles are outlined for trial designs intended to be deployed quickly, adapt flexibly and provide results soon enough to influence the course of the current epidemic rather than just providing evidence for use should Ebola break out again. Lessons are drawn for the conduct of clinical research in future outbreaks of infectious diseases, where the sequence of events may or may not be similar to the West African Ebola epidemic. PMID:26768556

  9. Evaluation of a cohabitation challenge model in immunization trials for channel catfish, Ictalurus punctatus (Rafinesque), against Ichthyophthirius multifiliis

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Calcein marking and cohabitation challenge have not been investigated in fish parasite research. This study evaluated a cohabitation challenge method in immunization trials against Ichthyophthirius multifiliis (Ich) using calcein, a fluorescent dye, to mark channel catfish Ictalurus punctatus (Rafi...

  10. Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials

    PubMed Central

    Lantos, John D.; Wendler, David; Septimus, Edward; Wahba, Sarita; Madigan, Rosemary; Bliss, Geraldine

    2015-01-01

    The classification system for categorizing the riskiness of a clinical trial is largely defined by the body of federal regulations known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration (FDA) codified in 21 CFR 50. This rule is applied according to the interpretation of institutional review boards (IRBs) charged with overseeing the research. If a clinical trial is determined by an IRB to constitute “minimal risk,” there are important practical implications: the IRB may allow waiver or alteration of the informed consent process; the study may be carried out in certain vulnerable populations; or the study may be reviewed by IRBs using an expedited process. However, it is unclear how the risk levels of pragmatic clinical trials (PCTs) should be assessed. Such trials typically compare existing, widely used medical therapies or interventions in the setting of routine clinical practice. Some of the therapies may be considered risky of themselves but the study comparing them may or may not add to that pre-existing level of risk. In this paper, we examine current research regulations and common interpretations of those regulations and suggest that current interpretation and application of regulations governing minimal-risk classification are marked by a high degree of variability and confusion, which in turn may ultimately harm patients by delaying or hindering potentially beneficial research. We advocate for a clear differentiation between the risks associated with a given therapy and the incremental risk incurred during research evaluating those therapies as a basic principle for evaluating the risk of a clinical study. We then examine two studies that incorporate aspects of PCTs and consider how various factors including patient perspectives, clinical equipoise, practice variation, and research methods such as cluster randomization contribute to current and evolving concepts of minimal risk, and how this

  11. Evaluation of statistical methods for the evaluation of observer trials for the assessment of the effectiveness of signature measures

    NASA Astrophysics Data System (ADS)

    Dunau, Patrick; Fitz, Daniel; Stein, Karin U.

    2015-10-01

    The statistical methods discussed in this paper are drawn from the area of machine learning or data mining as well as from descriptive statistics. These techniques are discussed with focus on their applicability to the results of observer trials in order to evaluate the effectiveness of signature measures. Signature measures aim at the change of the apparent signature of an object, e.g. a vehicle. So signature measures can be camouflage against infrared sensory, or they can be used for deception reasons. In order to evaluate the effectiveness of signature measures, observer trials provide an efficient method. The department of Signatorics of Fraunhofer IOSB developed a software tool named CARPET (Computer Aided inteRactive Performance Evaluation Tool) for the realization of observer trials. The benefit of this system is the reproducibility and uniformity of trials for every observer. The results from this system consist of marks, that were placed at particular times, as well as computer mouse positions recorded for each human observer. Based on the information gathered from these marks together with the known target object positions the statistical treatment can be done. For the statistics it has to be known to which target object the marks belong. The first problem considered in this paper concentrates on the correct labeling of the marks according to the target objects. The labeling is done using an expectation maximization scheme with the k-means clustering algorithm. The next step involves a second labeling. In this step a linear discriminant is used to decide whether a mark should be considered a hit or miss for every particular target object. After these decisions, a receiver-operating characteristics (ROC) analysis is performed in order to evaluate the detectability of each target object. Furthermore the sample mean and sample covariance formulas are used on the so called hit sets in order to approximate Gaussian distributions for every hit set. These

  12. Semiempirical evaluation of post-Hartree-Fock diagonal-Born-Oppenheimer corrections for organic molecules.

    PubMed

    Mohallem, José R

    2008-04-14

    Recent post-Hartree-Fock calculations of the diagonal-Born-Oppenheimer correction empirically show that it behaves quite similar to atomic nuclear mass corrections. An almost constant contribution per electron is identified, which converges with system size for specific series of organic molecules. This feature permits pocket-calculator evaluation of the corrections within thermochemical accuracy (10(-1) mhartree or kcal/mol). PMID:18412429

  13. ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’

    PubMed Central

    Fletcher-Smith, Joanna C; Walker, Dawn-Marie; Sprigg, Nikola; James, Marilyn; Walker, Marion F; Allatt, Kate; Mehta, Rajnikant; Pandyan, Anand D

    2016-01-01

    Introduction Approximately 70% of patients with stroke experience impaired arm function, which is persistent and disabling for an estimated 40%. Loss of function reduces independence in daily activities and impacts on quality of life. Muscles in those who do not recover functional movement in the stroke affected arm are at risk of atrophy and contractures, which can be established as early as 6 weeks following stroke. Pain is also common. This study aims to evaluate the feasibility of a randomised controlled trial to test the efficacy and cost-effectiveness of delivering early intensive electrical stimulation (ES) to prevent post-stroke complications in the paretic upper limb. Methods and analysis This is a feasibility randomised controlled trial (n=40) with embedded qualitative studies (patient/carer interviews and therapist focus groups) and feasibility economic evaluation. Patients will be recruited from the Stroke Unit at the Nottingham University Hospitals National Health Service (NHS) Trust within 72 h after stroke. Participants will be randomised to receive usual care or usual care and early ES to the wrist flexors and extensors for 30 min twice a day, 5 days a week for 3 months. The initial treatment(s) will be delivered by an occupational therapist or physiotherapist who will then train the patient and/or their nominated carer to self-manage subsequent treatments. Ethics and dissemination This study has been granted ethical approval by the National Research Ethics Service, East Midlands Nottingham1 Research Ethics Committee (ref: 15/EM/0006). To our knowledge, this is the first study of its kind of the early application (within 72 h post-stroke) of ES to both the wrist extensors and wrist flexors of stroke survivors with upper limb impairment. The results will inform the design of a definitive randomised controlled trial. Dissemination will include 2 peer-reviewed journal publications and presentations at national conferences. Trial

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

    NASA Astrophysics Data System (ADS)

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

    2010-05-01

    The purpose of this study was to evaluate the compound nerve action potential amplitude and latency measured to determine the degree of myelination and the number of fibers stimulated in a model of stimulated frog sciatic nerve laser at 810 nm as perioperative treatment after injury. It used 30 bullfrogs (Rana catesbeiana) to obtain 60 sciatic nerves forming four groups, groups 1 and 2 worked with nerves in vitro, were dissected in humid chambers for placing isolated organ, was recorded on compound nerve action potential, the second group laser was applied at 24, 48, 72, 96 and 120 hours and at the same time were placed in 10% formalin. Groups 3 and 4 are worked in vivo localizing the nerve and causing damage through compression, occurred over the compound nerve action potential to assess the degree of myelination and the number of fibers stimulated, the group 4 was applied to 810 nm laser (500 Hz, 10 J, 200 mW) after injury, after 48 hours, three frogs were sacrificed by introducing the nerves in 10% formalin. The latency recorded by stimulating the sciatic nerve of frog to 0.5 mA and 100 ms in groups 1 and 2 show significant differences (p<0.001 and p<000) as in the amplitude (p<000 and p<000). Groups 3 and 4, which was stimulated at 100 mA and 100 ms latency showed no statistically significant difference (p>000), as to the extent, if any statistically significant difference. (p<0.001 and p<0.000). The laser produces a favorable response in the treatment of paresthesia (post-traumatic neuropathy).

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

    SciTech Connect

    Escobar, Antonio S.; Ocampo, Arcelia F. M.; Hernandez, Maria G. H.; Jasso, Jose L. C.

    2010-05-31

    The purpose of this study was to evaluate the compound nerve action potential amplitude and latency measured to determine the degree of myelination and the number of fibers stimulated in a model of stimulated frog sciatic nerve laser at 810 nm as perioperative treatment after injury. It used 30 bullfrogs (Rana catesbeiana) to obtain 60 sciatic nerves forming four groups, groups 1 and 2 worked with nerves in vitro, were dissected in humid chambers for placing isolated organ, was recorded on compound nerve action potential, the second group laser was applied at 24, 48, 72, 96 and 120 hours and at the same time were placed in 10% formalin. Groups 3 and 4 are worked in vivo localizing the nerve and causing damage through compression, occurred over the compound nerve action potential to assess the degree of myelination and the number of fibers stimulated, the group 4 was applied to 810 nm laser (500 Hz, 10 J, 200 mW) after injury, after 48 hours, three frogs were sacrificed by introducing the nerves in 10% formalin. The latency recorded by stimulating the sciatic nerve of frog to 0.5 mA and 100 ms in groups 1 and 2 show significant differences (p<0.001 and p<000) as in the amplitude (p<000 and p<000). Groups 3 and 4, which was stimulated at 100 mA and 100 ms latency showed no statistically significant difference (p>000), as to the extent, if any statistically significant difference. (p<0.001 and p<0.000). The laser produces a favorable response in the treatment of paresthesia (post-traumatic neuropathy).

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

    PubMed Central

    Reza, Fazal; Ibrahim, Nur Sukainah

    2015-01-01

    Objective: Fiber post is cemented to a root canal to restore coronal tooth structure. This research aims to evaluate the effect of ultraviolet (UV) irradiation on bond strength of fiber post with resin cement. Materials and Methods: A total of 40 of the two types of fiber posts, namely, FRC Prostec (FRC) and Fiber KOR (KOR), were used for the experiment. UV irradiation was applied on top of the fiber post surface for 0, 15, 20, and 30 min. The irradiated surface of the fiber posts (n = 5) were immediately bonded with resin cement (Rely X U200) after UV irradiation. Shear bond strength (SBS) MPa was measured, and the dislodged area of post surfaces was examined with scanning electron microscopes. Changes in surface roughness (Ra) of the FRC group after UV irradiation were observed (n = 3) using atomic force microscopy. Data of SBS were statistically analyzed using one-way analysis of variance, followed by multiple comparisons (P < 0.05). Results: SBS was significantly higher for 20 min of UV irradiation of the FRC group while significantly higher SBS was observed with 15 min of UV irradiation of the KOR group. Resin cement was more evident (cohesive failure) on the dislodged post surface of the UV treated groups compared with the control. The surface roughness of the FRC post was Ra = 175.1 nm and Ra = 929.2 nm for the control and the 20 min group, respectively. Conclusions: Higher surface roughness of the UV irradiated group indicated formation of mechanical retention on the fiber post surface. Evidence of cohesive failure was observed which indicated higher SBS of fiber post with the UV irradiated group. PMID:25713488

  17. A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme: protocol for trial and integrated economic and process evaluation

    PubMed Central

    2010-01-01

    Background The benefits to health of a physically active lifestyle are well established and there is evidence that a sedentary lifestyle plays a significant role in the onset and progression of chronic disease. Despite a recognised need for effective public health interventions encouraging sedentary people with a medical condition to become more active, there are few rigorous evaluations of their effectiveness. Following NICE guidance, the Welsh national exercise referral scheme was implemented within the context of a pragmatic randomised controlled trial. Methods/Design The randomised controlled trial, with nested economic and process evaluations, recruited 2,104 inactive men and women aged 16+ with coronary heart disease (CHD) risk factors and/or mild to moderate depression, anxiety or stress. Participants were recruited from 12 local health boards in Wales and referred directly by health professionals working in a range of health care settings. Consenting participants were randomised to either a 16 week tailored exercise programme run by qualified exercise professionals at community sports centres (intervention), or received an information booklet on physical activity (control). A range of validated measures assessing physical activity, mental health, psycho-social processes and health economics were administered at 6 and 12 months, with the primary 12 month outcome measure being 7 day Physical Activity Recall. The process evaluation explored factors determining the effectiveness or otherwise of the scheme, whilst the economic evaluation determined the relative cost-effectiveness of the scheme in terms of public spending. Discussion Evaluation of such a large scale national public health intervention presents methodological challenges in terms of trial design and implementation. This study was facilitated by early collaboration with social research and policy colleagues to develop a rigorous design which included an innovative approach to patient referral and

  18. Process Evaluation Results from a School- and Community-Linked Intervention: The Trial of Activity for Adolescent Girls (TAAG)

    ERIC Educational Resources Information Center

    Young, D. R.; Steckler, A.; Cohen, S.; Pratt, C.; Felton, G.; Moe, S. G.; Pickrel, J.; Johnson, C. C.; Grieser, M.; Lytle, L. A.; Lee, J.-S.; Raburn, B.

    2008-01-01

    Process evaluation is a component of intervention research that evaluates whether interventions are delivered and received as intended. Here, we describe the process evaluation results for the Trial of Activity for Adolescent Girls (TAAG) intervention. The intervention consisted of four synergistic components designed to provide supportive school-…

  19. Bortezomib-based vs non-bortezomib-based post-transplantation treatment in multiple myeloma patients: a systematic review and meta-analysis of Phase III randomized controlled trials

    PubMed Central

    Liu, Xiaoping; He, Colin K; Meng, Xiangyu; He, Li; Li, Kaili; Liang, Qing; Shao, Liang; Liu, Shangqin

    2015-01-01

    Objective To evaluate the efficacy and safety of bortezomib-based vs non-bortezomib-based post-transplantation therapy in patients with multiple myeloma. Methods Data of relevant randomized controlled trials assessing the effect of bortezomib as post-transplantation consolidation or maintenance therapy was obtained through a comprehensive search. The outcome measures included response rate, progression-free survival, overall survival, and adverse events (AEs). The hazard ratio (HR), Cochran-Mantel-Haenszel odds ratio (OR), and 95% confidence interval (95% CI) were applied to evaluate the effect of bortezomib in relation to the end points such as progression-free survival, overall survival, response rate, and AEs. Results Three randomized controlled trials comprising 1,518 participants were included in this study. Pooled ORs for the rates of overall response, and complete response and near complete response, were 1.85 and 1.75, respectively. Pooled HR for progression-free survival favored bortezomib-based therapy over non-bortezomib-based therapy (0.73, 95% CI: 0.67–0.81), while no statistically significant difference could be found between the two groups regarding the pooled HR for 3-year overall survival. Moreover, incidence rates of overall adverse events and grade 3 and 4 peripheral neuropathy were similar in the bortezomib-based groups and the non-bortezomib-based groups (P=0.12 and P=0.41, respectively). The corresponding cumulative meta-analyses of the rates of overall response rate, complete response and near complete response, and grades 3 and 4 peripheral neuropathy supported the superiority of bortezomib-based maintenance therapy over consolidation therapy. Conclusion Bortezomib-based therapy after autologous stem cell transplantation, with tolerable AEs, could obviously improve the response as well as the outcome of multiple myeloma patients, particularly when bortezomib was administered as maintenance therapy. PMID:26109870

  20. An Evaluation of the Effectiveness of Recruitment Methods: The Staying Well after Depression Randomized Controlled Trial

    PubMed Central

    Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J. Mark G.

    2014-01-01

    Background Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited and trials often fail to report sufficient details about the recruitment sources and resources utilised. Purpose We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. Methods We describe eight recruitment methods utilised and two further sources not initiated by the research team and examine their efficacy in terms of (i) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial, (ii) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants, and (iii) comparison of sociodemographic characteristics of individuals recruited from different sources. Results Poster advertising, web-based advertising and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. Limitations It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other

  1. Implementation of an educational intervention to improve hand washing in primary schools: process evaluation within a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Process evaluations are useful for understanding how interventions are implemented in trial settings. This is important for interpreting main trial results and indicating how the intervention might function beyond the trial. The purpose of this study was to examine the reach, dose, fidelity, acceptability, and sustainability of the implementation of an educational hand washing intervention in primary schools, and to explore views regarding acceptability and sustainability of the intervention. Methods Process evaluation within a cluster randomised controlled trial, including focus groups with pupils aged 6 to 11, semi-structured interviews with teachers and external staff who coordinated the intervention delivery, and school reports and direct observations of the intervention delivery. Results The educational package was delivered in 61.4% of schools (85.2% of intervention schools, 37.8% of control schools following completion of the trial). Teachers and pupils reacted positively to the intervention, although concerns were raised about the age-appropriateness of the resources. Teachers adapted the resources to suit their school setting and pupils. Staff coordinating the intervention delivery had limited capacity to follow up and respond to schools. Conclusions The hand washing intervention was acceptable to schools, but its reach outside of a randomised trial, evidenced in the low proportion of schools in the control arm who received it after the trial had ended, suggests that the model of delivery may not be sustainable. Trial registration ISRCTN: ISRCTN93576146 PMID:23947388

  2. Evaluation of DICOM viewer software for workflow integration in clinical trials

    NASA Astrophysics Data System (ADS)

    Haak, Daniel; Page, Charles E.; Kabino, Klaus; Deserno, Thomas M.

    2015-03-01

    The digital imaging and communications in medicine (DICOM) protocol is nowadays the leading standard for capture, exchange and storage of image data in medical applications. A broad range of commercial, free, and open source software tools supporting a variety of DICOM functionality exists. However, different from patient's care in hospital, DICOM has not yet arrived in electronic data capture systems (EDCS) for clinical trials. Due to missing integration, even just the visualization of patient's image data in electronic case report forms (eCRFs) is impossible. Four increasing levels for integration of DICOM components into EDCS are conceivable, raising functionality but also demands on interfaces with each level. Hence, in this paper, a comprehensive evaluation of 27 DICOM viewer software projects is performed, investigating viewing functionality as well as interfaces for integration. Concerning general, integration, and viewing requirements the survey involves the criteria (i) license, (ii) support, (iii) platform, (iv) interfaces, (v) two-dimensional (2D) and (vi) three-dimensional (3D) image viewing functionality. Optimal viewers are suggested for applications in clinical trials for 3D imaging, hospital communication, and workflow. Focusing on open source solutions, the viewers ImageJ and MicroView are superior for 3D visualization, whereas GingkoCADx is advantageous for hospital integration. Concerning workflow optimization in multi-centered clinical trials, we suggest the open source viewer Weasis. Covering most use cases, an EDCS and PACS interconnection with Weasis is suggested.

  3. In vitro evaluation of temperature rise during different post space preparations

    PubMed Central

    Gokturk, Hakan; Ozkocak, Ismail; Taskan, Mehmet Murat; Aytac, Fatma; Karaarslan, Emine Sirin

    2015-01-01

    Objective: The aim of this study was to evaluate temperature alterations on the outer root surface during post space preparation with six different post drills by using an infrared thermometer. Materials and Methods: Sixty extracted single-rooted human mandibular incisor teeth were used. After root canal obturation, the specimens were divided into six groups (n = 10). During post space preparation, the temperature rises were measured in the middle third of the roots using a noncontact infrared thermometer with a sensitivity of 0.1°C. The temperature data were transferred from the thermometer to the computer and were observed graphically. Results: The maximum temperature rise was observed in Snowpost 2 (29.95 ± 10.2°C) (P < 0.001), but there were no significant differences among Snowpost 2 (29.95 ± 10.2°C), Snowpost 1 (24.6 ± 8.0°C), and Relyx 2 (17.68 ± 9.1°C) (P > 0.05). Conclusions: Although water coolant used, the critical temperature rise was observed on the outer root surface in all post drill systems. PMID:26929693

  4. Economic support to improve tuberculosis treatment outcomes in South Africa: a qualitative process evaluation of a cluster randomized controlled trial

    PubMed Central

    2014-01-01

    Background Poverty undermines the adherence of patients to tuberculosis treatment. A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients’ adherence to treatment, and their treatment outcomes. Although the trial showed a modest improvement in the treatment success rates of the intervention group, this was not statistically significant, due in part to the low fidelity to the trial intervention. A qualitative process evaluation, conducted in the final few months of the trial, explained some of the factors that contributed to this low fidelity. Methods In-depth interviews were conducted with patients who received vouchers, nurses in intervention clinics, personnel in shops who administered the vouchers, and managers of the TB Control Programme. These interviews were analyzed thematically. Results The low fidelity to the trial intervention can be explained by two main factors. The first was nurses’ tendency to ‘ration’ the vouchers, only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable. The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic dates, necessitating further visits to the clinics which they were not always able to make. Conclusions This process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial. It highlights the value of process evaluations as tools to explain the results of randomized trials and emphasizes the importance of implementers as ‘street level bureaucrats’ who may profoundly affect the way an intervention is administered. Trial registration Current Controlled Trials ISRCTN50689131, registered 21 April 2009. The trial protocol is available at the following web address: http://www

  5. Decision theory and the evaluation of risks and benefits of clinical trials.

    PubMed

    Bernabe, Rosemarie D C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M

    2012-12-01

    Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making. PMID:22819925

  6. A new cognitive evaluation battery for Down syndrome and its relevance for clinical trials

    PubMed Central

    de Sola, Susana; de la Torre, Rafael; Sánchez-Benavides, Gonzalo; Benejam, Bessy; Cuenca-Royo, Aida; del Hoyo, Laura; Rodríguez, Joan; Catuara-Solarz, Silvina; Sanchez-Gutierrez, Judit; Dueñas-Espin, Ivan; Hernandez, Gimena; Peña-Casanova, Jordi; Langohr, Klaus; Videla, Sebastia; Blehaut, Henry; Farre, Magi; Dierssen, Mara; Cuenca-Royo, Aida

    2015-01-01

    The recent prospect of pharmaceutical interventions for cognitive impairment of Down syndrome (DS) has boosted a number of clinical trials in this population. However, running the trials has raised some methodological challenges and questioned the prevailing methodology used to evaluate cognitive functioning of DS individuals. This is usually achieved by comparing DS individuals to matched healthy controls of the same mental age. We propose a new tool, the TESDAD Battery that uses comparison with age-matched typically developed adults. This is an advantageous method for probing the clinical efficacy of DS therapies, allowing the interpretation and prediction of functional outcomes in clinical trials. In our DS population the TESDAD battery permitted a quantitative assessment of cognitive defects, which indicated language dysfunction and deficits in executive function, as the most important contributors to other cognitive and adaptive behavior outcomes as predictors of functional change in DS. Concretely, auditory comprehension and functional academics showed the highest potential as end-point measures of therapeutic intervention for clinical trials: the former as a cognitive key target for therapeutic intervention, and the latter as a primary functional outcome measure of clinical efficacy. Our results also emphasize the need to explore the modulating effects of IQ, gender and age on cognitive enhancing treatments. Noticeably, women performed significantly better than men of the same age and IQ in most cognitive tests, with the most consistent differences occurring in memory and executive functioning and negative trends rarely emerged on quality of life linked to the effect of age after adjusting for IQ and gender. In sum, the TESDAD battery is a useful neurocognitive tool for probing the clinical efficacy of experimental therapies in interventional studies in the DS population suggesting that age-matched controls are advantageous for determining normalization of

  7. A new cognitive evaluation battery for Down syndrome and its relevance for clinical trials.

    PubMed

    de Sola, Susana; de la Torre, Rafael; Sánchez-Benavides, Gonzalo; Benejam, Bessy; Cuenca-Royo, Aida; Del Hoyo, Laura; Rodríguez, Joan; Catuara-Solarz, Silvina; Sanchez-Gutierrez, Judit; Dueñas-Espin, Ivan; Hernandez, Gimena; Peña-Casanova, Jordi; Langohr, Klaus; Videla, Sebastia; Blehaut, Henry; Farre, Magi; Dierssen, Mara

    2015-01-01

    The recent prospect of pharmaceutical interventions for cognitive impairment of Down syndrome (DS) has boosted a number of clinical trials in this population. However, running the trials has raised some methodological challenges and questioned the prevailing methodology used to evaluate cognitive functioning of DS individuals. This is usually achieved by comparing DS individuals to matched healthy controls of the same mental age. We propose a new tool, the TESDAD Battery that uses comparison with age-matched typically developed adults. This is an advantageous method for probing the clinical efficacy of DS therapies, allowing the interpretation and prediction of functional outcomes in clinical trials. In our DS population the TESDAD battery permitted a quantitative assessment of cognitive defects, which indicated language dysfunction and deficits in executive function, as the most important contributors to other cognitive and adaptive behavior outcomes as predictors of functional change in DS. Concretely, auditory comprehension and functional academics showed the highest potential as end-point measures of therapeutic intervention for clinical trials: the former as a cognitive key target for therapeutic intervention, and the latter as a primary functional outcome measure of clinical efficacy. Our results also emphasize the need to explore the modulating effects of IQ, gender and age on cognitive enhancing treatments. Noticeably, women performed significantly better than men of the same age and IQ in most cognitive tests, with the most consistent differences occurring in memory and executive functioning and negative trends rarely emerged on quality of life linked to the effect of age after adjusting for IQ and gender. In sum, the TESDAD battery is a useful neurocognitive tool for probing the clinical efficacy of experimental therapies in interventional studies in the DS population suggesting that age-matched controls are advantageous for determining normalization of

  8. A randomized controlled trial evaluating the impact of knowledge translation and exchange strategies

    PubMed Central

    2009-01-01

    Context Significant resources and time are invested in the production of research knowledge. The primary objective of this randomized controlled trial was to evaluate the effectiveness of three knowledge translation and exchange strategies in the incorporation of research evidence into public health policies and programs. Methods This trial was conducted with a national sample of public health departments in Canada from 2004 to 2006. The three interventions, implemented over one year in 2005, included access to an online registry of research evidence; tailored messaging; and a knowledge broker. The primary outcome assessed the extent to which research evidence was used in a recent program decision, and the secondary outcome measured the change in the sum of evidence-informed healthy body weight promotion policies or programs being delivered at health departments. Mixed-effects models were used to test the hypotheses. Findings One hundred and eight of 141 (77%) health departments participated in this study. No significant effect of the intervention was observed for primary outcome (p < 0.45). However, for public health policies and programs (HPPs), a significant effect of the intervention was observed only for tailored, targeted messages (p < 0.01). The treatment effect was moderated by organizational research culture (e.g., value placed on research evidence in decision making). Conclusion The results of this study suggest that under certain conditions tailored, targeted messages are more effective than knowledge brokering and access to an online registry of research evidence. Greater emphasis on the identification of organizational factors is needed in order to implement strategies that best meet the needs of individual organizations. Trial Registration The trial registration number and title are as follows: ISRCTN35240937 -- Is a knowledge broker more effective than other strategies in promoting evidence-based physical activity and healthy body weight programming

  9. Prospective randomized trial of iliohypogastric-ilioinguinal nerve block on post-operative morphine use after inpatient surgery of the female reproductive tract

    PubMed Central

    Wehbe, Salim A; Ghulmiyyah, Labib M; Dominique, El-Khawand H; Hosford, Sarah L; Ehleben, Carole M; Saltzman, Steven L; Sills, Eric Scott

    2008-01-01

    Objective To determine the impact of pre-operative and intra-operative ilioinguinal and iliohypogastric nerve block on post-operative analgesic utilization and length of stay (LOS). Methods We conducted a prospective randomized double-blind placebo controlled trial to assess effectiveness of ilioinguinal-iliohypogastric nerve block (IINB) on post-operative morphine consumption in female study patients (n = 60). Patients undergoing laparotomy via Pfannenstiel incision received injection of either 0.5% bupivacaine + 5 mcg/ml epinephrine for IINB (Group I, n = 28) or saline of equivalent volume given to the same site (Group II, n = 32). All injections were placed before the skin incision and after closure of rectus fascia via direct infiltration. Measured outcomes were post-operative morphine consumption (and associated side-effects), visual analogue pain scores, and hospital length of stay (LOS). Results No difference in morphine use was observed between the two groups (47.3 mg in Group I vs. 45.9 mg in Group II; p = 0.85). There was a trend toward lower pain scores after surgery in Group I, but this was not statistically significant. The mean time to initiate oral narcotics was also similar, 23.3 h in Group I and 22.8 h in Group II (p = 0.7). LOS was somewhat shorter in Group I compared to Group II, but this difference was not statistically significant (p = 0.8). Side-effects occurred with similar frequency in both study groups. Conclusion In this population of patients undergoing inpatient surgery of the female reproductive tract, utilization of post-operative narcotics was not significantly influenced by IINB. Pain scores and LOS were also apparently unaffected by IINB, indicating a need for additional properly controlled prospective studies to identify alternative methods to optimize post-surgical pain management and reduce LOS. PMID:19040739

  10. Phase II Trial of Graft-versus-Host Disease Prophylaxis with Post-Transplantation Cyclophosphamide after Reduced-Intensity Busulfan/Fludarabine Conditioning for Hematological Malignancies.

    PubMed

    Alousi, Amin M; Brammer, Jonathan E; Saliba, Rima M; Andersson, Borje; Popat, Uday; Hosing, Chitra; Jones, Roy; Shpall, Elizabeth J; Khouri, Issa; Qazilbash, Muzaffar; Nieto, Yago; Shah, Nina; Ahmed, Sairah; Oran, Betul; Al Atrash, Gheath; Ciurea, Stefan; Kebriaei, Partow; Chen, Julianne; Rondon, Gabriela; Champlin, Richard E

    2015-05-01

    Graft-versus-host disease (GVHD) prophylaxis with post-transplantation cyclophosphamide (CY) after ablative HLA-matched bone marrow (BM) transplantation has been reported to have comparable rates of acute GVHD with an apparent reduction in chronic GVHD and infections when compared to historical prophylaxis with a calcineurin-inhibitor (CNI) and methotrexate (MTX). We conducted a phase II trial of post-transplantation CY (post-CY) after reduced-intensity conditioning (RIC) using intravenous busulfan (area under the curve of 4000 micromolar minute), fludarabine (40 mg/m(2)) for 4 days, and CY 50 mg/kg on days +3 and +4 after BM or peripheral blood (PB) transplantations from matched related (MRD) or unrelated donors (MUD). MUD recipients received antithymocyte globulin (ATG); however, a later amendment removed ATG. Forty-nine patients were treated (acute myeloid leukemia/myelodysplastic syndrome, 82%). Median age was 62 years (range, 39 to 72). Fifteen patients received an MRD (9 PB/6 BM); 34 had a MUD (2 PB/32 BM). The cumulative incidence of grade II to IV acute GVHD, III to IV acute GVHD, and chronic GVHD was 58%, 22%, and 18%, respectively. A matched cohort analysis compared outcomes to tacrolimus/methotrexate GVHD prophylaxis and indicated higher rates of acute GVHD grade II to IV (46% versus 19%; hazard ratio [HR], 2.8; P = .02) and treatment-related mortality (HR, 3.3; P = .035) and worse overall survival (HR, 1.9; P = .04) with post-CY. The incidence of chronic GVHD and CMV reactivation did not differ. This study suggests that post-CY should not be used as sole GVHD prophylaxis after a RIC transplantation from HLA-matched donors. PMID:25667989

  11. Post-trial dopaminergic modulation of conditioned catalepsy: A single apomorphine induced increase/decrease in dopaminergic activation immediately following a conditioned catalepsy response can reverse/enhance a haloperidol conditioned and sensitized catalepsy response.

    PubMed

    Oliveira, Lucas Rangel; Dias, Flávia Regina Cruz; Santos, Breno Garone; Silva, Jade Leal Loureiro; Carey, Robert J; Carrera, Marinete Pinheiro

    2016-09-15

    Haloperidol can induce catalepsy and this drug effect can be conditioned as well as sensitized to contextual cues. We used a paired/unpaired Pavlovian conditioning protocol to establish haloperidol catalepsy conditioned and sensitized responses. Groups of rats were given 10 daily catalepsy tests following administration of vehicle (n=24) or haloperidol (1.0mg/kg) either paired (n=18) or unpaired (n=18) to testing. Subsequently, testing for conditioning was conducted and conditioning and sensitization of catalepsy were observed selectively in the paired group. Immediately following a second test for catalepsy conditioning, the groups were subdivided into 4 vehicle groups, 3 unpaired haloperidol groups and 3 paired haloperidol groups and were given one of three post-trial treatments (vehicle, 0.05mg/kg or 2.0mg/kg apomorphine). One day later the conditioned catalepsy test 3 was carried out and on the next day, a haloperidol challenge test was performed. The post-trial apomorphine treatments had major effects on the paired groups upon both conditioning and the haloperidol challenge test. The low dose apomorphine post-trial treatment enhanced both the conditioned and the haloperidol sensitized catalepsy responses. The high dose apomorphine post-trial treatment eliminated conditioned catalepsy and eliminated the initial acute catalepsy response to haloperidol that was induced in the vehicle control groups. These results demonstrate the sensitivity of conditioned drug cues to modification by increases/decreases in activity of the dopamine system in the immediate post-trial interval after a conditioning trial. This demonstration that post-trial dopaminergic drug treatments can modify conditioned drug behavior has broad implications for conditioned drug effects. PMID:27173428

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

    PubMed

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

    2015-09-01

    Solid organ transplantation as a treatment for end stage organ failure has been an accepted treatment option for decades. Despite advances in medicine and technology, and increased awareness of organ donation and transplantation, the gap between supply and demand continues to widen. Living donation has been an option that has increased the number of transplants despite the continued shortage of deceased organs. In the early 2000s live donor transplantation reached an all-time high in the United States. As a result, a consensus meeting was convened in 2000 to increase the oversight of living donor transplantation. Both the Centers for Medicare and Medicaid Services and the United Network for Organ Sharing developed regulations that transplant programs performing live donor transplantation. These regulations and guidelines involve the education, evaluation, informed consent process and living donor follow-up care. Two areas in which had significant changes included the psychosocial and the independent living donor advocate (ILDA) evaluation. The purpose of this paper was to outline the current regulations and guidelines associated with the psychosocial and ILDA evaluation as well as provide further recommendations for the administration of a high quality evaluation of living donors. The goals and timing of the evaluation and education of donors; qualifications of the health care providers performing the evaluation; components of the evaluation; education provided to donors; documentation of the evaluation; participation in the selection committee meeting; post-decline and post-donation care of donors is described. Caveats including the paired donor exchange programs and non-directed and directed donation are also considered. PMID:26293351

  13. A Pilot Study Evaluating the Effectiveness of Platelet-Rich Plasma Therapy for Treating Degenerative Tendinopathies: A Randomized Control Trial with Synchronous Observational Cohort

    PubMed Central

    Wesner, Marni; Defreitas, Terry; Bredy, Heather; Pothier, Louisa; Qin, Ziling; McKillop, Ashley B.; Gross, Douglas P.

    2016-01-01

    Objective This pilot study aimed to inform future research evaluating the effectiveness of Platelet Rich Plasma (PRP) injection for tendinopathy. Design Randomized control trial (RCT) and synchronous observational cohort studies. For the RCT, consecutive consenting patients treated at an academic sports medicine clinic were randomly assigned to either a PRP or placebo control group. Setting The Glen Sather Sport Medicine Clinic, Edmonton, Canada. Patients The RCT included 9 participants with rotator cuff tendinopathy. The cohort study included 178 participants with a variety of tendinopathies. Interventions Patients receiving PRP were injected with 4 ml of platelets into the supraspinatus and/or infraspinatus, while patients in the placebo group were injected with 4ml of saline. All participants undertook a 3-month standardized, home-based, daily exercise program. Main Outcome Measures Participants in the RCT were re-evaluated 3, and 6 months post-injection. Change scores before and after injection on pain, disability and MRI-documented pathology outcomes were compared. In the cohort study, pain and disability were measured at 1, 2 and 3 months post-injection. Results For the RCT, 7 participants received PRP and 2 received placebo injections. Patients receiving PRP reported clinically important improvements in pain (>1.5/10 on VAS), disability (>15 point DASH change), and tendon pathology while those receiving placebo injections did not. In the observational cohort, statistically and clinically significant improvements in pain and disability were observed. Conclusion This pilot study provides information for planning future studies of PRP effectiveness. Preliminary results indicate intratendinous, ultrasound-guided PRP injection may lead to improvements in pain, function, and MRI-documented tendon pathology. Trial Registration Controlled-Trials.com ISRCTN68341698 PMID:26849812

  14. The Sonoma Water Evaluation Trial (SWET): A randomized drinking water intervention trial to reduce gastrointestinal illness in older adults

    EPA Science Inventory

    Objectives. We estimate the risk of highly credible gastrointestinal illness (HCGI) among adults 55 and older in a community drinking tap water meeting current U.S. standards. Methods. We conducted a randomized, triple-blinded, crossover trial in 714 households (988 indiv...

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

    PubMed

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

    2014-03-01

    This report describes the design and evaluation of an interprofessional pilot training course aimed at pre-licensure practitioners working with post-stroke patients in community-based settings. The course was developed by community-based practitioners from nine health professions. Course learning activities included traditional methods (lectures) and interactive modules (problem-based learning and exchange-based learning). The study's aim was to assess the program's effectiveness in adapting and incorporating knowledge, skills and self-confidence when delivering tertiary care in therapeutic pool environments; gauge adoption of course principles into practice, and assess overall course satisfaction. Methods of evaluation included conceptual mapping of course format, pre- and post-questionnaires, daily reflection questionnaires, course satisfaction survey and adoption survey, 10 weeks follow-up. Overall, the findings indicate students' knowledge, skills and self-confidence in delivering effective post-stroke care increased following the training. Students reported adopting clinical practices in 10 weeks follow-up. Implications for designing interprofessional curricula are discussed. PMID:24195682

  16. A cluster randomised controlled trial and economic evaluation of a structured training programme for caregivers of inpatients after stroke: the TRACS trial.

    PubMed Central

    Forster, A; Dickerson, J; Young, J; Patel, A; Kalra, L; Nixon, J; Smithard, D; Knapp, M; Holloway, I; Anwar, S; Farrin, A

    2013-01-01

    , mood and cost-effectiveness, with final follow-up at 12 months. RESULTS No differences in primary outcomes were found between the groups at 6 months. Adjusted mean differences were -0.2 points [95% confidence interval (CI) -3.0 to 2.5 points; p = 0.866; intracluster correlation coefficient (ICC) = 0.027] for the patient Nottingham Extended Activities of Daily Living score and 0.5 points (95% CI -1.7 to 2.7 points; p = 0.660; ICC = 0.013) for the Caregiver Burden Scale. Furthermore, no differences were detected in any of the secondary outcomes. Intervention compliance varied across the units. Half of the participating centres had a compliance rating of > 60%. Analysis showed no evidence of higher levels of patient independence or lower levels of caregiver burden in the SRUs with better levels of intervention compliance. The economic evaluation suggests that from a patient and caregiver perspective, health and social care costs, societal costs and outcomes are similar for the intervention and control groups at 6 months, 12 months and over 1 year. CONCLUSIONS We have conducted a robust multicentre, cluster randomised trial, demonstrating for the first time that this methodology is feasible in stroke rehabilitation research. There was no difference between the LSCTC and usual care with respect to improving stroke patients' recovery, reducing caregivers' burden, or improving other physical and psychological outcomes, nor was it cost-effective compared with usual care. Compliance with the intervention varied, but analysis indicated that a dose effect was unlikely. It is possible that the immediate post-stroke period may not be the ideal time for the delivery of structured training. The intervention approach might be more relevant if delivered after discharge by community-based teams. TRIAL REGISTRATION Current Controlled Trials ISRCTN49208824. FUNDING This project was funded by the MRC and is managed by the NIHR (project number 09/800/10) on behalf of the MRC

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

    PubMed

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

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research. PMID:26983223

  18. The practice of ‘doing’ evaluation: lessons learned from nine complex intervention trials in action

    PubMed Central

    2014-01-01

    Background There is increasing recognition among trialists of the challenges in understanding how particular ‘real-life’ contexts influence the delivery and receipt of complex health interventions. Evaluations of interventions to change health worker and/or patient behaviours in health service settings exemplify these challenges. When interpreting evaluation data, deviation from intended intervention implementation is accounted for through process evaluations of fidelity, reach, and intensity. However, no such systematic approach has been proposed to account for the way evaluation activities may deviate in practice from assumptions made when data are interpreted. Methods A collective case study was conducted to explore experiences of undertaking evaluation activities in the real-life contexts of nine complex intervention trials seeking to improve appropriate diagnosis and treatment of malaria in varied health service settings. Multiple sources of data were used, including in-depth interviews with investigators, participant-observation of studies, and rounds of discussion and reflection. Results and discussion From our experiences of the realities of conducting these evaluations, we identified six key ‘lessons learned’ about ways to become aware of and manage aspects of the fabric of trials involving the interface of researchers, fieldworkers, participants and data collection tools that may affect the intended production of data and interpretation of findings. These lessons included: foster a shared understanding across the study team of how individual practices contribute to the study goals; promote and facilitate within-team communications for ongoing reflection on the progress of the evaluation; establish processes for ongoing collaboration and dialogue between sub-study teams; the importance of a field research coordinator bridging everyday project management with scientific oversight; collect and review reflective field notes on the progress of the

  19. Trial of "Force and Motion Conceptual Evaluation" Tests in Japanese High Schools

    NASA Astrophysics Data System (ADS)

    Ryu, Junpei; Iwama, Toru; Yamazaki, Toshiaki; Ogawa, Masashi; Sakatani, Takafumi; Uchimura, Hiroshi; Taniguchi, Kazunari; Murata, Takatoshi

    A tentative version of Japanese translation of "Force and Motion Conceptual Evaluation" was used in a preliminary research to investigate high school students' conceptual understanding of Newtonian dynamics after the students attended formal courses on the topic in 2006-07. The results obtained were generally similar to those of post-tests after traditional lectures in universities in U.S.A.. It was also used as pre- and post-test at two extramural classes on dynamics based on the active learning materials. The results of those uses suggested a well validated version of the translated test and more systematic large scale research can contribute well to physics education research in Japan.

  20. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    PubMed

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26184686

  1. Design and selection of soy breads used for evaluating isoflavone bioavailability in clinical trials.

    PubMed

    Ahn-Jarvis, Jennifer H; Riedl, Kenneth M; Schwartz, Steven J; Vodovotz, Yael

    2013-03-27

    To modulate isoflavone aglycone composition within a soy functional food, soy ingredients were processed and evaluated in a soy bread system intended for clinical trials. A soy flour/soy milk mixture (SM) was boiled, fermented, steamed, or roasted prior to dough preparation. The isoflavone compositions of five processed SM and their corresponding breads combined with and without β-glucosidase-rich almonds were examined using HPLC. Isoflavone malonyl-glucosides (>80%) were converted into acetyl and simple glucoside forms (substrates more favorable for β-glucosidase) in steamed and roasted SM. Their corresponding breads had isoflavones predominately as aglycones (∼75%) with soy-almond bread with steamed SM being more consumer acceptable than roasted. Isoflavone composition in soy bread was stable during frozen storage and toasting. A suitable glycoside-rich soy bread (31.6 ± 2.1 mg aglycone equiv/slice) using unprocessed SM and an aglycone-rich soy-almond bread (31.1 ± 1.9 mg aglycone equiv/slice) using steamed SM were developed to evaluate fundamental questions of isoflavone bioavailability in clinical trials. PMID:23451757

  2. Design and Selection of Soy Breads Used for Evaluating Isoflavone Bioavailability in Clinical Trials

    PubMed Central

    Ahn-Jarvis, Jennifer H.; Riedl, Kenneth M.; Schwartz, Steven J.; Vodovotz, Yael

    2013-01-01

    To modulate isoflavone aglycone composition within a soy functional food, soy ingredients were processed and evaluated in a soy bread system intended for clinical trials. A soy flour/soy milk mixture (SM) was boiled, fermented, steamed, or roasted prior to dough preparation. The isoflavone compositions of five processed SM and their corresponding breads combined with and without β-glucosidase-rich almonds were examined using HPLC. Isoflavone malonyl-glucosides (>80%) were converted into acetyl and simple glucoside forms (substrates more favorable for β-glucosidase) in steamed and roasted SM. Their corresponding breads had isoflavones predominately as aglycones (∼75%) with soy–almond bread with steamed SM being more consumer acceptable than roasted. Isoflavone composition in soy bread was stable during frozen storage and toasting. A suitable glycoside-rich soy bread (31.6 ± 2.1 mg aglycone equiv/slice) using unprocessed SM and an aglycone-rich soy–almond bread (31.1 ± 1.9 mg aglycone equiv/slice) using steamed SM were developed to evaluate fundamental questions of isoflavone bioavailability in clinical trials. PMID:23451757

  3. Qualitative findings from an exploratory trial of the Healthy Lifestyles Programme (HeLP) and their implications for the process evaluation in the definitive trial

    PubMed Central

    2014-01-01

    Background Approximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required. However, despite the increasing number of school-based interventions to prevent obesity, results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status. The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours. Methods A process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of; the trial design (including the trial outcomes) and the HeLP Programme and whether it is able to engage schools, children and their families. Data was collected using interviews with teachers (n = 12) and parents (n = 17) and six focus groups with children (n = 47) and a questionnaire for parents of children in the intervention schools. Interview and focus group data relating to the intervention was analysed using framework analysis. Results Four schools and 201 children participated in the exploratory trial. The data showed that the trial design was feasible and acceptable for schools and children. Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme (value, compatibility with the curriculum and enjoyment) and two themes emerged in relation to engagement (‘knowledge and awareness’ and ‘taking messages on board’). The latter could be broken down into 4 subthemes (‘initiating discussion with family and friends’, ‘acceptance of family rules’, ‘increased responsibility’ and ‘the importance of the mode and agent of delivery’). The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with

  4. Pilot study evaluating broccoli sprouts in advanced pancreatic cancer (POUDER trial) - study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Pancreatic ductal adenocarcinoma (PDA) is one of the most aggressive malignancies with marked resistance to chemo- and radiotherapy. PDA-cancer stem cells (CSCs) are not targeted by current therapies and may be a reason for poor prognosis. Studies indicate that diets rich in cabbage, broccoli, and cauliflower offer cancer preventative and therapeutic benefits. Recent experimental studies have confirmed these findings and demonstrated that isothiocyanate, sulforaphane, and the polyphenol, quercetin, effectively reduced tumor growth and enhanced the sensitivity of the cancer cells to current chemotherapeutics. The aim of the present study is to test the feasibility of a randomized controlled trial on the application of freeze-dried broccoli sprouts in patients with advanced PDA. Methods and study design The study is designed as a prospective randomized, double-blinded pilot trial with a treatment and a placebo-controlled arm in a single center setting. A total number of forty patients (18 years or older) in two parallel groups with advanced, surgically non-resectable PDA under palliative chemotherapy are planned for recruitment. Patients in the treatment group will receive fifteen capsules of the study substance per day (90 mg of active sulforaphane) during the chemotherapy treatment course. Patients in the placebo group will receive the same capsule size and portion distribution with inactive substances (mainly methylcellulose). The follow-up duration is one year. Feasibility of the study substance, adverse effects, and patient compliance, as well as levels of serum tumor markers (CEA, CA 19-9), quality of life, and patient overall survival rates will be assessed at defined points of time. Discussion The POUDER trial is expected to transfer promising experimental and epidemiological data into a clinical pilot study to assess the effectiveness of broccoli sprout extracts in the treatment of advanced PDA. The study objectives will provide data on the

  5. Evaluating the performance of copula models in phase I-II clinical trials under model misspecification

    PubMed Central

    2014-01-01

    Background Traditionally, phase I oncology trials are designed to determine the maximum tolerated dose (MTD), defined as the highest dose with an acceptable probability of dose limiting toxicities(DLT), of a new treatment via a dose escalation study. An alternate approach is to jointly model toxicity and efficacy and allow dose escalation to depend on a pre-specified efficacy/toxicity tradeoff in a phase I-II design. Several phase I-II trial designs have been discussed in the literature; while these model-based designs are attractive in their performance, they are potentially vulnerable to model misspecification. Methods Phase I-II designs often rely on copula models to specify the joint distribution of toxicity and efficacy, which include an additional correlation parameter that can be difficult to estimate. We compare and contrast three models for the joint probability of toxicity and efficacy, including two copula models that have been proposed for use in phase I-II clinical trials and a simple model that assumes the two outcomes are independent. We evaluate the performance of the various models through simulation both when the models are correct and under model misspecification. Results Both models exhibited similar performance, as measured by the probability of correctly identifying the optimal dose and the number of subjects treated at the optimal dose, regardless of whether the data were generated from the correct or incorrect copula, even when there is substantial correlation between the two outcomes. Similar results were observed for a simple model that assumes independence, even in the presence of strong correlation. Further simulation results indicate that estimating the correlation parameter in copula models is difficult with the sample sizes used in Phase I-II clinical trials. Conclusions Our simulation results indicate that the operating characteristics of phase I-II clinical trials are robust to misspecification of the copula model but that a simple

  6. Can Clinical Trials Requiring Frequent Participant Contact Be Conducted Over the Internet? Results From an Online Randomized Controlled Trial Evaluating a Topical Ointment for Herpes Labialis

    PubMed Central

    Kabbara, Karim; Clark, Rachael; McAlindon, Tim

    2004-01-01

    Background The Internet has tremendous appeal for conducting randomized clinical trials and may be especially applicable to trials requiring frequent participant contact. Trials of cold sore remedies, for example, often require daily clinic visits during outbreaks, imposing substantial burden on participants. An Internet-based randomized clinical trial design may reduce this burden, permitting frequent symptom reports with considerably less effort. Objective To evaluate the feasibility of a Web-based randomized clinical trial requiring frequent participant interaction, using a 6-month, double-blind, randomized, placebo-controlled pilot trial of a topical ointment containing dioctyl sodium sulfosuccinate (DSS) (Zilex; Meditech Pharmaceuticals, Inc, Scottsdale, Arizona, USA) intended for treatment of recurrent herpes labialis. A secondary objective was to obtain preliminary data on effectiveness outcomes, to assist in planning a fully-powered trial of DSS. Methods Adults with physician-confirmed herpes labialis were recruited to apply to the trial. Eligible applicants were randomized to DSS or placebo, mailed to them upon enrolment with instructions to apply topically every 2 hours for the duration of every cold sore outbreak. Participants were instructed to complete online questionnaires at 2-week intervals and, at the initiation of a cold sore, daily "outbreak questionnaires" until outbreak termination. Feasibility outcome measures included trial participant characteristics, frequency of cold sores, participant retention and adherence (to study medication), and data completeness. Treatment effectiveness outcome measures included outbreak duration, days to crust formation, and pain. Results Of the 292 individuals applying, 182 screened eligible; 32 participants with confirmed herpes labialis enrolled in the trial. 16 were randomized into the verum group and 16 into the placebo group. 29 (91%) participants completed the trial. During the trial, 34 outbreaks were

  7. Evaluating the efficacy and cost-effectiveness of web-based indicated prevention of major depression: design of a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. Web-based interventions have shown to be effective in reducing depressive symptom severity. However, it is not known whether web-based interventions may also be effective in preventing the onset of MDD. The aim of this study is to evaluate the (cost-) effectiveness of an indicated web-based guided self-help intervention (GET.ON Mood Enhancer Prevention) on the onset of MDD. Methods/Design A randomised controlled trial (RCT) will be conducted to compare the (cost-) effectiveness of the GET.ON Mood Enhancer Prevention training with a control condition exclusively receiving online-based psychoeducation on depression. Adults with subthreshold depression (N = 406) will be recruited from the general population and randomised to one of the two conditions. The primary outcome is time to onset of MDD within a 12-months follow-up period. MDD will be assessed according to DSM-IV criteria as assessed by the telephone-administered Structured Clinical Interview for DSM-IV (SCID). Time to onset of MDD will be assessed using life charts. Secondary outcomes include changes on various indicators of depressive symptom severity, anxiety and quality of life from baseline to post-treatment, to a 6-month and a 12-month follow up. Additionally, an economic evaluation using a societal perspective will be conducted to examine the intervention’s cost-effectiveness. Discussion This is one of the first randomised controlled trials that examines the effect of an indicated guided self-help web-based intervention on the incidence of major depression. If shown to be effective, the intervention will contribute to reducing the disease burden due to MDD in the general population. Trial registration German Clinical Trial Registration DRKS00004709. PMID:24485283

  8. Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial [ISRCTN34974819

    PubMed Central

    Haut, Antonie; Köpke, Sascha; Gerlach, Anja; Mühlhauser, Ingrid; Haastert, Burkhard; Meyer, Gabriele

    2009-01-01

    Background Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aimed to reduce physical restraints and minimise centre variations. Methods/Design Cluster-randomised controlled trial with nursing homes randomised either to the intervention group or to the control group with standard information. The intervention comprises a structured information programme for nursing staff, information materials for legal guardians and residents' relatives and a one-day training workshop for nominated nurses. A total of 36 nursing home clusters including approximately 3000 residents will be recruited. Each cluster has to fulfil the inclusion criteria of at least 20% prevalence of physical restraints at baseline. The primary endpoint is the number of residents with at least one physical restraint at six months. Secondary outcome measures are the number of falls and fall-related fractures. Discussion If successful, the intervention should be implemented throughout Germany. In case the intervention does not succeed, a three-month pre-post-study with an optimised intervention programme within the control group will follow the randomised trial. Trial registration ISRCTN34974819 PMID:19735564

  9. Menopausal estrogen therapy and non-Hodgkin's lymphoma: A post-hoc analysis of women's health initiative randomized clinical trial.

    PubMed

    Kato, Ikuko; Chlebowski, Rowan T; Hou, Lifang; Wactawski-Wende, Jean; Ray, Roberta M; Abrams, Judith; Bock, Cathryn; Desai, Pinkal; Simon, Michael S

    2016-02-01

    Estrogens are important immunomodulators, exerting significant effects on cell proliferation, apoptosis, cytokine production and differentiation of hematopoietic cells. Estrogen receptors are expressed on normal B and T lymphocytes, bone marrow and in leukemia and lymphoma cell lines. Epidemiologic evidence for the association of menopausal hormone use with risk of non-Hodgkin's lymphoma (NHL) has been mixed; however, all of the investigations have been observational. We analyzed the data from Women's Health Initiative hormone therapy trials where conjugated equine estrogens (CEE; 0.625 mg/d) plus medroxyprogesterone acetate (MPA; 2.5 mg/d) (n = 16,654) or CEE alone (women with prior hysterectomy) (n = 10,685) were tested against placebos and the intervention lasted a median of 5.6 years in the CEE + MPA trial and 7.2 years in the CEE alone trial. During 13 years of follow-up through September 20, 2013 383 incident NHL cases were identified. We used the intent-to-treat approach to calculate incidence rates of NHL, hazards ratios (HR) and 95% confidence intervals (CI) by treatment group. Incidence of NHL was virtually the same in the treatment and placebo groups. The HR was 1.02 (95%CI 0.74-1.39) for CEE alone, 0.98 (95% CI 0.76-1.28) for CEE+MPA, and 1.00 (95% CI 0.82-1.22) for both combined. There were no specific NHL subtypes associated with either type of the treatment, except a marginally decreased risk of plasma cell neoplasms (HR= 0.53 95% CI 0.27-1.03) in the CEE-alone group. These results do not support a role of estrogen alone or combined with progestin in the development of NHL among postmenopausal women. PMID:26365326

  10. The Childhood Adenotonsillectomy Trial (CHAT): Rationale, Design, and Challenges of a Randomized Controlled Trial Evaluating a Standard Surgical Procedure in a Pediatric Population

    PubMed Central

    Redline, Susan; Amin, Raouf; Beebe, Dean; Chervin, Ronald D.; Garetz, Susan L.; Giordani, Bruno; Marcus, Carole L.; Moore, Renee H.; Rosen, Carol L.; Arens, Raanan; Gozal, David; Katz, Eliot S.; Mitchell, Ronald B.; Muzumdar, Hiren; Taylor, H.G.; Thomas, Nina; Ellenberg, Susan

    2011-01-01

    Each year, over 500,000 adenotonsillectomies (AT), mostly for the treatment of pediatric obstructive sleep apnea (OSA) are performed in the US in children under 15 years of age. No definitive study, however, has been yet conducted that has rigorously evaluated the effectiveness of AT for not only improving sleep disordered breathing, but also for improving clinically relevant outcomes, such as neurocognitive function, behavior, and quality of life. The Childhood Adenotonsillectomy Trial (CHAT) was designed to assess neuropsychological and health outcomes in children randomized to receive early AT (eAT) as compared to Watchful Waiting with Supportive Care (WWSC). Important secondary goals of the study are to evaluate outcomes in subgroups defined by obesity and race. This paper addresses key elements in the design and implementation of a controlled trial for a widely used “standard practice” surgical intervention in a pediatric population, that include establishment of standardized data collection procedures across sites for a wide variety of data types, establishment of equipoise, and approaches for minimizing unblinding of selected key personnel. The study framework that was established should provide a useful template for other pediatric controlled studies or other studies that evaluate surgical interventions. Citation: Redline S; Amin R; Beebe D; Chervin RD; Garetz SL; Giordani B; Marcus CL; Moore RH; Rosen CL; Arens R; Gozal D; Katz ES; Mitchell RB; Muzumdar H; Taylor HG; Thomas N; Ellenberg S. The Childhood Adenotonsillectomy Trial (CHAT): rationale, design, and challenges of a randomized controlled trial evaluating a standard surgical procedure in a pediatric population. SLEEP 2011;34(11):1509-1517. PMID:22043122

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

    PubMed

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

    2015-11-01

    Determined efficacies of benzoyl peroxide may be affected by study design, implementation, and vehicle effects. We sought to elucidate areas that may allow improvement in determining accurate treatment efficacies by determining rates of active treatment and vehicle responders in randomized controlled trials assessing the efficacy of topical benzoyl peroxide to treat acne. We conducted a systematic review of randomized vehicle-controlled trials evaluating the efficacy of topical benzoyl peroxide for the treatment of acne. We compared response rates of vehicle treatment arms versus those in benzoyl peroxide arms. Twelve trials met inclusion criteria with 2818 patients receiving benzoyl peroxide monotherapy treatment and 2004 receiving vehicle treatment. The average percent reduction in total number of acne lesions was 44.3 (SD = 9.2) and 27.8 (SD = 21.0) for the active and vehicle treatment groups, respectively. The average reduction in non-inflammatory lesions was 41.5 % (SD = 9.4) in the active treatment group and 27.0 % (SD = 20.9) in the vehicle group. The average percent decrease in inflammatory lesions was 52.1 (SD = 10.4) in the benzoyl peroxide group and 34.7 (SD = 22.7) in the vehicle group. The average percentage of participants achieving success per designated study outcomes was 28.6 (SD = 17.3) and 15.2 (SD = 9.5) in the active treatment and vehicle groups, respectively. Patient responses in randomized controlled trials evaluating topical acne therapies may be affected by clinical trial design, implementation, the biologic effects of vehicles, and natural disease progression. "No treatment" groups may facilitate determination of accurate treatment efficacies. PMID:26048131

  12. Post Irradiation Evaluation of Thermal Control Coatings and Solid Lubricants to Support Fission Surface Power Systems

    NASA Technical Reports Server (NTRS)

    Bowman, Cheryl L.; Jaworske, Donald A.; Stanford, Malcolm K.; Persinger, Justin A.; Khorsandi, Behrooz; Blue, Thomas E.

    2007-01-01

    The development of a nuclear power system for space missions, such as the Jupiter Icy Moons Orbiter or a lunar outpost, requires substantially more compact reactor design than conventional terrestrial systems. In order to minimize shielding requirements and hence system weight, the radiation tolerance of component materials within the power conversion and heat rejection systems must be defined. Two classes of coatings, thermal control paints and solid lubricants, were identified as material systems for which limited radiation hardness information was available. Screening studies were designed to explore candidate coatings under a predominately fast neutron spectrum. The Ohio State Research Reactor Facility staff performed irradiation in a well characterized, mixed energy spectrum and performed post irradiation analysis of representative coatings for thermal control and solid lubricant applications. Thermal control paints were evaluated for 1 MeV equivalent fluences from 10(exp 13) to 10(exp 15) n per square centimeters. No optical degradation was noted although some adhesive degradation was found at higher fluence levels. Solid lubricant coatings were evaluated for 1 MeV equivalent fluences from 10(exp 15) to 10(exp 16) n per square centimeters with coating adhesion and flexibility used for post irradiation evaluation screening. The exposures studied did not lead to obvious property degradation indicating the coatings would have survived the radiation environment for the previously proposed Jupiter mission. The results are also applicable to space power development programs such as fission surface power for future lunar and Mars missions.

  13. Lessons learnt from post EIS evaluations of national road schemes in Ireland

    SciTech Connect

    King, E.A.; O'Malley, V.P.

    2012-01-15

    The Irish National Roads Authority (NRA) recently completed over twenty post environmental impact assessment evaluations of noise chapters prepared as part of Environmental Impact Statements (EISs) for new national road schemes in Ireland. The study focused on a range of issues including a review of noise monitoring procedures, noise prediction methodologies and an assessment of the effectiveness of noise mitigation measures currently in use on national road schemes. This review was carried out taking cognisance of best international practices for noise assessment and methodologies used to mitigate road traffic noise. The primary focus of the study was to assess the actual noise impacts of national road scheme developments and to revise, where necessary, methodologies recommended in the current NRA guidance document describing the treatment of noise on national road schemes. This paper presents a summary of the study and identifies a number of key areas that should be considered prior to the development of future guidance documents. - Highlights: Black-Right-Pointing-Pointer Presents a post-EIS evaluation of noise assessments for national roads in Ireland. Black-Right-Pointing-Pointer The effectiveness of some noise mitigation measures is critically evaluated. Black-Right-Pointing-Pointer Issues related to the current EIS noise assessment methodologies are discussed. Black-Right-Pointing-Pointer Implications for alterations to the NRA noise guidelines.

  14. Post Irradiation Evaluation of Thermal Control Coatings and Solid Lubricants to Support Fission Surface Power Systems

    NASA Astrophysics Data System (ADS)

    Bowman, Cheryl L.; Jaworske, Donald A.; Stanford, Malcolm K.; Persinger, Justin A.; Khorsandi, Behrooz; Blue, Thomas E.

    2007-01-01

    The development of a nuclear power system for space missions, such as the Jupiter Icy Moons Orbiter or a lunar outpost, requires substantially more compact reactor design than conventional terrestrial systems. In order to minimize shielding requirements and hence system weight, the radiation tolerance of component materials within the power conversion and heat rejection systems must be defined. Two classes of coatings, thermal control paints and solid lubricants, were identified as material systems for which limited radiation hardness information was available. Screening studies were designed to explore candidate coatings under a predominately fast neutron spectrum. The Ohio State Research Reactor Facility staff performed irradiation in a well characterized, mixed energy spectrum and performed post irradiation analysis of representative coatings for thermal control and solid lubricant applications. Thermal control paints were evaluated for 1 MeV equivalent fluences from 1013 to 1015 n/cm2. No optical degradation was noted although some adhesive degradation was found at higher fluence levels. Solid lubricant coatings were evaluated for 1 MeV equivalent fluences from 1015 to 1016 n/cm2 with coating adhesion and flexibility used for post irradiation evaluation screening. The exposures studied did not lead to obvious property degradation indicating the coatings would have survived the radiation environment for the previously proposed Jupiter mission. The results are also applicable to space power development programs such as fission surface power for future lunar and Mars missions.

  15. Post Irradiation Evaluation of Thermal Control Coatings and Solid Lubricants to Support Fission Surface Power Systems

    SciTech Connect

    Bowman, Cheryl L.; Jaworske, Donald A.; Stanford, Malcolm K.; Persinger, Justin A.; Khorsandi, Behrooz; Blue, Thomas E.

    2007-01-30

    The development of a nuclear power system for space missions, such as the Jupiter Icy Moons Orbiter or a lunar outpost, requires substantially more compact reactor design than conventional terrestrial systems. In order to minimize shielding requirements and hence system weight, the radiation tolerance of component materials within the power conversion and heat rejection systems must be defined. Two classes of coatings, thermal control paints and solid lubricants, were identified as material systems for which limited radiation hardness information was available. Screening studies were designed to explore candidate coatings under a predominately fast neutron spectrum. The Ohio State Research Reactor Facility staff performed irradiation in a well characterized, mixed energy spectrum and performed post irradiation analysis of representative coatings for thermal control and solid lubricant applications. Thermal control paints were evaluated for 1 MeV equivalent fluences from 1013 to 1015 n/cm2. No optical degradation was noted although some adhesive degradation was found at higher fluence levels. Solid lubricant coatings were evaluated for 1 MeV equivalent fluences from 1015 to 1016 n/cm2 with coating adhesion and flexibility used for post irradiation evaluation screening. The exposures studied did not lead to obvious property degradation indicating the coatings would have survived the radiation environment for the previously proposed Jupiter mission. The results are also applicable to space power development programs such as fission surface power for future lunar and Mars missions.

  16. PHASE II TRIAL OF GVHD PROPHYLAXIS WITH POST-TRANSPLANTATION CYCLOPHOSPHAMIDE FOLLOWING REDUCED-INTENSITY BUSULFAN/FLUDARABINE (BU/FLU) CONDITIONING FOR HEMATOLOGICAL MALIGNANCIES

    PubMed Central

    Alousi, Amin M.; Brammer, Jonathan E.; Saliba, Rima M.; Andersson, Borje; Popat, Uday; Hosing, Chitra; Jones, Roy; Shpall, Elizabeth J; Khouri, Issa; Qazilbash, Muzaffar; Nieto, Yago; Shah, Nina; Ahmed, Sairah; Oran, Betul; Atrash, Gheath Al; Ciurea, Stefan; Kebriaei, Partow; Chen, Julianne; Rondon, Gabriela; Champlin, Richard

    2016-01-01

    GVHD-prophylaxis with post-transplant cyclophosphamide (CY) following ablative HLA-matched bone marrow (BM) transplantation has been reported to have comparable rates of acute GVHD with an apparent reduction in chronic GVHD and infections. We conducted a phase II trial of post-CY following reduced-intensity conditioning (RIC) using intravenous busulfan (AUC of 4,000 micromolar-minutes), Fludarabine (40mg/m2) for 4 days and CY 50mg/kg on days +3 and +4 following BM or peripheral blood (PB) transplants from matched related (MRD) or unrelated donors (MUD). MUD- recipients received anti-thymocyte globulin (ATG); however, a later amendment removed ATG. 49 patients were treated (AML/MDS: 82%). Median age was 62 years (range, 39–72). Fifteen patients received a MRD (9 PB/6 BM); 34 had a MUD (2 PB/32 BM). The cumulative incidence of grade II–IV, III–IV acute and chronic GVHD was 58%, 22% and 18%. A matched-cohort analysis compared outcomes to tacrolimus/methotrexate GVHD prophylaxis and indicated higher rates of acute GVHD grade II–IV (46% versus 19%, HR=2.8, p=0.02) and treatment-related mortality (HR 3.3, p=0.035) and worse overall survival (HR=1.9, p=0.04) with post-Cy. The incidence of chronic GVHD and CMV reactivation did not differ. This study suggests that post-transplant CY should not be used as sole GVHD-prophylaxis following a RIC transplant from HLA matched donors. PMID:25667989

  17. A comparison of post operative pain and hospital stay between Lichtenstein’s repair and Laparoscopic Transabdominal Preperitoneal (TAPP) repair of inguinal hernia: A randomized controlled trial

    PubMed Central

    Salma, Umme; Ahmed, Ishtiaq; Ishtiaq, Sundas

    2015-01-01

    Objective: To compare the open Lichtenstein repair and laparoscopic mesh repair for direct inguinal hernias in terms of immediate post operative pain and length of hospital stay. Methods: This randomized control trial was conducted at Benazir Bhutto Hospital Rawalpindi from January 2009 to June 2010. All patients presenting in the surgical OPD with direct inguinal hernia, ASA I/II, were randomly divided in two equal groups. Group-I, patients underwent Lichtenstein’s repair and Group-II had hernioplasty by laparoscopic method (TAPP). Post operative pain intensity assessed by VAS and hospital stay measured in hours. Results: A total 60 patients of direct inguinal hernia were studied. The mean age was 61.48±7. The range of postoperative pain experienced was 5.55 as per VAS among all patients. In group-I (open hernioplasty) majority of patients (53.33%, n=16) experience severe type of pain where as in group-II, moderate severity of pain was reported by large number of patients (63.34%, n=19). The mean post operative pain intensity as per VAS was 6.23 in group-I and 4.43 in group-II patients. The mean length of hospital stay was slightly less (35.10 hrs) in group-I as compared to group-II (38.70 hrs). Conclusion: There is definitely less post operative pain after laparoscopic repair but hospital stay is same in both the procedures but laparoscopic procedure does increase the cost. PMID:26648987

  18. Qualitative methods in a randomised controlled trial: the role of an integrated qualitative process evaluation in providing evidence to discontinue the intervention in one arm of a trial of a decision support tool

    PubMed Central

    Murtagh, M J; Thomson, R G; May, C R; Rapley, T; Heaven, B R; Graham, R H; Kaner, E F; Stobbart, L; Eccles, M P

    2007-01-01

    Objective To understand participants' experiences and understandings of the interventions in the trial of a computerised decision support tool in patients with atrial fibrillation being considered for anti‐coagulation treatment. Design Qualitative process evaluation carried out alongside the trial: non‐participant observation and semistructured interviews. Participants 30 participants aged >60 years taking part in the trial of a computerised decision support tool. Results Qualitative evidence provided the rationale to undertake a decision to discontinue one arm of the trial on the basis that the intervention in that arm, a standard gamble values elicitation exercise was causing confusion and was unlikely to produce valid data on participant values. Conclusions Qualitative methods used alongside a trial allow an understanding of the process and progress of a trial, and provide evidence to intervene in the trial if necessary, including evidence for the rationale to discontinue an intervention arm of the trial. PMID:17545351

  19. Metabolic Implications when Employing Heavy Pre- and Post-Exercise Rapid-Acting Insulin Reductions to Prevent Hypoglycaemia in Type 1 Diabetes Patients: A Randomised Clinical Trial

    PubMed Central

    Campbell, Matthew D.; Walker, Mark; Trenell, Michael I.; Luzio, Steven; Dunseath, Gareth; Tuner, Daniel; Bracken, Richard M.; Bain, Stephen C.; Russell, Mark; Stevenson, Emma J.; West, Daniel J.

    2014-01-01

    Aim To examine the metabolic, gluco-regulatory-hormonal and inflammatory cytokine responses to large reductions in rapid-acting insulin dose administered prandially before and after intensive running exercise in male type 1 diabetes patients. Methods This was a single centre, randomised, controlled open label study. Following preliminary testing, 8 male patients (24±2 years, HbA1c 7.7±0.4%/61±4 mmol.l−1) treated with insulin's glargine and aspart, or lispro attended the laboratory on two mornings at ∼08:00 h and consumed a standardised breakfast carbohydrate bolus (1 g carbohydrate.kg−1BM; 380±10 kcal) and self-administered a 75% reduced rapid-acting insulin dose 60 minutes before 45 minutes of intensive treadmill running at 73.1±0.9% VO2peak. At 60 minutes post-exercise, patients ingested a meal (1 g carbohydrate.kg−1BM; 660±21 kcal) and administered either a Full or 50% reduced rapid-acting insulin dose. Blood glucose and lactate, serum insulin, cortisol, non-esterified-fatty-acids, β-Hydroxybutyrate, and plasma glucagon, adrenaline, noradrenaline, IL-6, and TNF-α concentrations were measured for 180 minutes post-meal. Results All participants were analysed. All glycaemic, metabolic, hormonal, and cytokine responses were similar between conditions up to 60 minutes following exercise. Following the post-exercise meal, serum insulin concentrations were lower under 50% (p<0.05) resulting in 75% of patients experiencing hyperglycaemia (blood glucose ≥8.0 mmol.l−1; 50% n = 6, Full n = 3). β-Hydroxybutyrate concentrations decreased similarly, such that at 180 minutes post-meal concentrations were lower than rest under Full and 50%. IL-6 and TNF-α concentrations remained similar to fasting levels under 50% but declined under Full. Under 50% IL-6 concentrations were inversely related with serum insulin concentrations (r = −0.484, p = 0.017). Conclusions Heavily reducing rapid-acting insulin dose with a carbohydrate bolus before

  20. A randomized controlled dismantling trial of post-workshop consultation strategies to increase effectiveness and fidelity to an evidence-based psychotherapy for Posttraumatic stress disorder

    PubMed Central

    2013-01-01

    Background Posttraumatic Stress Disorder (PTSD) is a serious mental health condition with substantial costs to individuals and society. Among military veterans, the lifetime prevalence of PTSD has been estimated to be as high as 20%. Numerous research studies have demonstrated that short-term cognitive-behavioral psychotherapies, such as Cognitive Processing Therapy (CPT), lead to substantial and sustained improvements in PTSD symptoms. Despite known benefits, only a minority of clinicians provide these therapies. Transferring this research knowledge into clinical settings remains one of the largest hurdles to improving the health of veterans with PTSD. Attending a workshop alone is insufficient to promote adequate knowledge transfer and sustained skill; however, relatively little research has been conducted to identify effective post-training support strategies. Methods The current study investigates whether clinicians receiving post-workshop support (six-month duration) will deliver CPT with greater fidelity (i.e., psychotherapy adherence and competence) and have improved patient outcomes compared with clinicians receiving no formal post-workshop support. The study conditions are: technology-enhanced group tele-consultation; standard group tele-consultation; and fidelity assessment with no consultation. The primary outcome is independent assessment (via audio-recordings) of the clinicians’ adherence and competence in delivering CPT. The secondary outcome is observed changes in patient symptoms during and following treatment as a function of clinician fidelity. Post-consultation interviews with clinicians will help identify facilitators and barriers to psychotherapy skill acquisition. The study results will inform how best to implement and transfer evidence-based psychotherapy (e.g., CPT) to clinical settings to attain comparable outcomes to those observed in research settings. Discussion Findings will deepen our understanding of how much and what type of

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

    PubMed

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

    2007-10-01

    A randomized between-group design was used to evaluate the efficacy of a video intervention to reduce post-traumatic stress disorder (PTSD) and other mental health problems, implemented prior to the forensic medical examination conducted within 72 h post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) aged 15 years or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with a prior rape history relative to scores among women with a prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior rape history who were in the video relative to the standard care condition. Small effects indicating higher PTSD and Beck Anxiety Inventory (BAI) scores among women without a prior rape history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a videoxprior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms. PMID:17585872

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

    PubMed

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

    2012-01-01

    A post audit for a reactive transport model used to evaluate acid mine drainage treatment systems is presented herein. The post audit is based on a paired synoptic approach in which hydrogeochemical data are collected at low (existing conditions) and elevated (following treatment) pH. Data obtained under existing, low-pH conditions are used for calibration, and the resultant model is used to predict metal concentrations observed following treatment. Predictions for Al, As, Fe, H(+), and Pb accurately reproduce the observed reduction in dissolved concentrations afforded by the treatment system, and the information provided in regard to standard attainment is also accurate (predictions correctly indicate attainment or nonattainment of water quality standards for 19 of 25 cases). Errors associated with Cd, Cu, and Zn are attributed to misspecification of sorbent mass (precipitated Fe). In addition to these specific results, the post audit provides insight in regard to calibration and sensitivity analysis that is contrary to conventional wisdom. Steps taken during the calibration process to improve simulations of As sorption were ultimately detrimental to the predictive results, for example, and the sensitivity analysis failed to bracket observed metal concentrations. PMID:22074087

  3. Post-audits of Three Groundwater Models for Evaluating Plume Containment

    NASA Astrophysics Data System (ADS)

    Andersen, P. F.

    2003-12-01

    Groundwater extraction systems were designed using numerical models at three sites within a U.S. Army Ammunition Plant in Tennessee. Each site, and hence model, has unique qualities such as boundary conditions, extensiveness of the contaminant plume, and quantity and quality of hydrogeologic data. Performance of each of these extraction systems has been evaluated throughout their operation, providing an opportunity to perform post-audits on the accuracy of the groundwater models that were used in their design. Areas of comparison between the models and the observed response in the natural systems include hydraulic head, drawdown, horizontal and vertical gradients, and extent of capture zones. The results of the post-audits show the importance of using all available data in the construction and calibration of the models, the importance of having sufficient data, and the critical nature of an accurate conceptual model. The post-audits also show that although it may be possible to assess the accuracy of the model predictions, it is often not possible to explain the reasons for discrepancies between predicted and observed results. From a practical perspective, parameter uncertainty is important to account for in the development of the models and subsequent design of the extraction systems.

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

    USGS Publications Warehouse

    Runkel, R.L.; Kimball, B.A.; Walton-Day, K.; Verplanck, P.L.; Broshears, R.E.

    2012-01-01

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

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

    USGS Publications Warehouse

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

    2012-01-01

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

  6. Serum-based protein biomarkers of bladder cancer: A pre- and post-operative evaluation.

    PubMed

    Bansal, Navneeta; Gupta, Ashok Kumar; Gupta, Ashish; Sankhwar, Satya Narain; Mahdi, Abbas Ali

    2016-05-30

    Urinary bladder cancer (BC) is the fifth most common cancer worldwide with alarming mortality. Shortcomings of urine cytology and cystoscopy and sparse improvements in the survival rate prompt us to evolve surrogate serum based protein biomarkers to identify BC at an early stage. Previously, we showed that aberrant expression of S100A4, S100A8, S100A9, carbonic anhydrase I (CA I) and Annexin V proteins in pre-operative BC serum compared to healthy controls (HC) (Clin Chim Acta, 2014; 36: 97-103). Here we further evaluate and validate these findings with follow-up post-operative BC patients. This study was conducted on 160 sera samples comprising healthy controls (HC, n=52), pre-operative (n=55) and post-operative (n=53) BC patients. Enzyme-linked immunosorbent assay (ELISA) was used to appraise the aberrantly expressed proteins. ELISA results revealed that the expression levels of S100A8, S100A9, S100A4, and CA I were gradually and significantly reduced; concomitantly, Annexin V was progressively and significantly increased in post-operative compared to pre-operative BC sera samples. Serum protein biomarkers appear to be an encouraging and least-invasive approach for BC identification and prognosticating patient outcomes. PMID:26922578

  7. 77 FR 59223 - Extension of Post-Sale Evaluation Period for Consolidated Central Gulf of Mexico Planning Area...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-26

    ... of Mexico Planning Area Lease Sale 216/222 AGENCY: Bureau of Ocean Energy Management (BOEM), Interior..., 2012, the post-sale evaluation period for Consolidated Central Gulf of Mexico Planning Area Lease...

  8. Evaluation of a Web-Based Intervention to Promote Hand Hygiene: Exploratory Randomized Controlled Trial

    PubMed Central

    Miller, Sascha; Schlotz, Wolff; Little, Paul

    2011-01-01

    Background Hand-washing is regarded as a potentially important behavior for preventing transmission of respiratory infection, particularly during a pandemic. Objective The objective of our study was to evaluate whether a Web-based intervention can encourage more frequent hand-washing in the home, and to examine potential mediators and moderators of outcomes, as a necessary first step before testing effects of the intervention on infection rates in the PRIMIT trial (PRimary care trial of a website based Infection control intervention to Modify Influenza-like illness and respiratory infection Transmission). Methods In a parallel-group pragmatic exploratory trial design, 517 nonblinded adults recruited through primary care were automatically randomly assigned to a fully automated intervention comprising 4 sessions of tailored motivational messages and self-regulation support (n = 324) or to a no-intervention control group (n = 179; ratio 2:1). Hand-washing frequency and theory of planned behavior cognitions relating to hand-washing were assessed by online questionnaires at baseline (in only half of the control participants, to permit evaluation of effects of baseline assessment on effect sizes), at 4 weeks (postintervention; all participants), and at 12 weeks. Results Hand-washing rates in the intervention group were higher at 4 weeks than in the control group (mean 4.40, n = 285 and mean 4.04, n = 157, respectively; P < .001, Cohen d = 0.42) and remained higher at 12 weeks (mean 4.45, n = 282 and mean 4.12, n = 154, respectively; P < .001, Cohen d = 0.34). Hand-washing intentions and positive attitudes toward hand-washing increased more from baseline to 4 weeks in the intervention group than in the control group. Mediation analyses revealed positive indirect effects of the intervention on change in hand-washing via intentions (coefficient = .15, 95% confidence interval [CI], .08–.26) and attitudes (coefficient = 0.16, 95% CI, .09–.26). Moderator analyses

  9. Comparative evaluation of fracture resistance of various post systems using different luting agents under tangential loading

    PubMed Central

    Aggarwal, Rajnish; Gupta, Swati; Tandan, Amrit; Gupta, Narendra Kumar; Dwivedi, Ravi; Aggarwal, Renu

    2013-01-01

    Objective The purpose of this in vitro study was to evaluate the fracture resistance of various post system using different luting agents under tangential loading after wet thermocycling. Material & methods Seventy freshly extracted maxillary central incisors were endodontically treated and post-spaces were prepared to receive different post system. They were assigned to 7 groups. Composite resin was used as core material in all the groups. Three type of post system: prefabricated post system (ParaPost® XP™), fibre post (ParaPost® fiber Lux™), cast nickel–chromium alloy post and two type of luting cements dual cure resin cement (ParaCem®, Whaledent) and glass ionomer cement (Fuji I, GC) were used. The specimens were thermocycled and subjected to tangential loading at a crosshead speed of 1.5 mm/min. The failure loads were recorded and data were statistically analyzed with one-way ANOVA (p < 0.05) and Student's t tests (p < 0.001). Results Significant differences of fracture resistance were detected among groups (p < 0.001). The greatest number of repairable fracture mode was recorded in fibre posts and resin cement system. Conclusions Within the limitations of this in vitro study, it can be stated that fibre posts can be recommended as a better alternative to the cast post and cores and prefabricated metallic posts in the anterior region and resin cement might give additional fracture resistance when used for post and crown cementation. PMID:25737886

  10. A pilot randomized clinical trial evaluating the impact of genetic counseling for serious mental illnesses

    PubMed Central

    Hippman, Catriona; Ringrose, Andrea; Inglis, Angela; Cheek, Joanna; Albert, Arianne Y. K.; Remick, Ronald; Honer, William G.; Austin, Jehannine C

    2016-01-01

    Objective The serious mental illnesses schizophrenia, schizoaffective disorder, and bipolar disorder are complex conditions affecting 1–4% of the population. Individuals with serious mental illnesses express interest in genetic counseling; an intervention showing promise for increasing patient knowledge and adaptation. This trial aimed to evaluate the effects of genetic counseling for people with serious mental illnesses as compared to an educational intervention or waitlist. Methods A pilot three-arm (each n=40; genetic counseling, a control intervention involving an educational booklet, or waitlist), parallel group, randomized clinical trial was conducted from September 2008–November 2011 in Vancouver, Canada. Participants with schizophrenia, bipolar disorder, or schizoaffective disorder (DSM-IV) completed outcome measures assessing knowledge, risk perception, internalized stigma, and perceived control over illness at baseline and one-month follow-up. The Brief Symptom Inventory was administered to control for current symptoms. Analyses included linear mixed effects models and chi-squared tests. Results Knowledge increased for genetic counseling/educational booklet compared to waitlist at follow-up (LRT=19.33, df=1, Holm-adjusted p=0.0003, R2LMM(m)=0.17). Risk perception accuracy increased at follow-up for genetic counseling compared to waitlist (Yates’ continuity corrected χ2=9.1, df=1, Bonferroni p=0.003) and educational booklet (Yates’ continuity corrected χ2=8.2, df=1, Bonferroni p=0.004). There were no significant differences between groups for stigma or perceived control scores. Conclusions Genetic counseling and the educational booklet improved knowledge; and genetic counseling, but not the educational booklet, improved risk perception accuracy for this population. The impact of genetic counseling on internalized stigma and perceived control is worth further investigation. Genetic counseling should be considered for patients with serious mental

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

    NASA Technical Reports Server (NTRS)

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

    2016-01-01

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

  12. Evaluating the effectiveness of a post-license education program for young novice drivers in Belgium.

    PubMed

    Brijs, Kris; Cuenen, Ariane; Brijs, Tom; Ruiter, Robert A C; Wets, Geert

    2014-05-01

    The disproportionately large number of traffic accidents of young novice drivers highlights the need for an effective driver education program. The Goals for Driving Education (GDE) matrix shows that driver education must target both lower and higher levels of driver competences. Research has indicated that current education programs do not emphasize enough the higher levels, for example awareness and insight. This has raised the importance of insight programs. On the Road (OtR), a Flemish post-license driver education program, is such an insight program that aims to target these higher levels. The program focus is on risky driving behavior like speeding and drink driving. In addition, the program addresses risk detection and risk-related knowledge. The goal of the study was to do an effect evaluation of this insight program at immediate post-test and 2 months follow-up. In addition, the study aimed to generalize the results of this program to comparable programs in order to make usable policy recommendations. A questionnaire based on the Theory of Planned Behavior (TPB) was used in order to measure participants' safety consciousness of speeding and drink driving. Moreover, we focused on risk detection and risk-related knowledge. Participants (N=366) were randomly assigned to a baseline-follow-up group or a post-test-follow-up group. Regarding speeding and driving, we found OtR to have little effect on the TPB variables. Regarding risk detection, we found no significant effect, even though participants clearly needed substantial improvement when stepping into the program. Regarding risk-related knowledge, the program did result in a significant improvement at post-test and follow-up. It is concluded that the current program format is a good starting point, but that it requires further attention to enhance high level driving skills. Program developers are encouraged to work in a more evidence-based manner when they select target variables and methods to influence

  13. The Positive Outlook Study: A Randomised Controlled Trial Evaluating Online Self-Management for HIV Positive Gay Men.

    PubMed

    Millard, Tanya; Agius, Paul A; McDonald, Karalyn; Slavin, Sean; Girdler, Sonya; Elliott, Julian H

    2016-09-01

    The aim of this paper was to evaluate the effectiveness of an online self-management program in improving health outcomes and well-being for gay men living with HIV in Australia. The online Positive Outlook Program was based on self-efficacy theory and used a self-management approach to enhance HIV-positive gay men's skills, confidence and abilities to manage the psychosocial issues associated with HIV in daily life. The 7-week program was delivered in closed groups and comprised information modules, action-planning activities, moderated discussion boards, and weekly peer-facilitated 'live chats'. A randomised controlled trial was conducted to establish the effectiveness of the Positive Outlook program compared to a 'usual care' control. Participants were HIV-positive gay men 18 years or older living in Australia. Primary outcomes were evaluated at three time-points (baseline, post-intervention and 12-week's post-intervention follow-up) and included HIV-related quality of life (PROQOL-HIV), outcomes of health education (HeiQ) and HIV specific self-efficacy (Positive Outlook Self-Efficacy Scale). A total of 132 gay men with HIV in Australia were randomly allocated to the intervention (n = 68) or usual care control (n = 64) groups. Maximum likelihood marginal-linear modelling indicated significant improvement in the intervention group on the PROQOL-HIV subscales of body change (p = 0.036), social relationships (p = 0.035) and emotional distress (p = 0.031); the HeiQ subscales of health-directed activity (p = 0.048); constructive attitudes and approaches (p = 0.015); skill and technique acquisition (p = 0.046) and health service navigation (p = 0.008); and the Positive Outlook Self-Efficacy Scale on the subscales of relationships (p = 0.019); social participation (p = 0.006); and emotions (p = 0.041). Online delivery of self-management programs is feasible and has the potential to improve quality of life, self-management skills and domain

  14. Method for the evaluation of stretch blow molding simulations with free blow trials

    NASA Astrophysics Data System (ADS)

    Zimmer, Johannes; Stommel, Markus

    2013-12-01

    Finite-Element (FE) simulations are a valuable tool to support the analysis and optimization of production processes. In order to achieve realistic simulation results, a consistent simulation set-up followed by an evaluation through experiments is crucial. Stretch Blow Molding (SBM) is a commonly applied forming method to produce thin walled bottles. Polyethylene terephthalate (PET) preforms are biaxially stretched into a closed cavity to form a bottle. In this process the thermo-mechanical material behavior during forming greatly influences the performance of the end product and consequently plays a key role for a reliable process simulation. To ensure a realistic material representation in the simulation model, an adequate material model is calibrated with stress-strain curves from biaxial tests. Thin PET-sheets are stretched under defined temperatures and strain rates. These representative experiments include process simplifications regarding geometry, heating and deformation parameters. Therefore, an evaluation step subsequent to the simulation set-up is inevitable. This paper presents a method for extracting temperature dependent stress-strain-curves from experiments close to the production process which enables the crucial evaluation of a process simulation. In the SBM process, the wall thickness distribution of the bottle refers to the preform deformation over time but does not fully define the thermo-mechanical material behavior. In the presented method, PET-preforms receive thermal treatment with Infrared (IR)-heaters from an SBM-machine and are subsequently inflated into free air (free-blow-trial). An IR-camera is used to obtain the temperature distribution on the preform immediately before blowing. Two high speed cameras are synchronized with a pressure sensor to consequently calculate reliable stress-strain curves at any point on the preform surface. These data is finally compared to results from FE-simulations of the free blow trials.

  15. Evaluating the effectiveness of personal resilience and enrichment programme (PREP) for HIV prevention among female sex workers: a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Female sex workers (FSWs) are often considered as the vector, if not reservoir, of HIV and other sexually transmitted infections. Building upon the existing evidence on the role of psychological health in sexual health, the aim of this protocol is to describe a trial investigating the effectiveness of the Personal Resilience and Enrichment Programme (PREP), a resilience-promoting intervention that targets at psychological well-being i.e. self-esteem, self-efficacy and coping, to facilitate adaptation and ultimately safe sexual practices among FSWs, which could be an innovative strategy in controlling the spread of these infections. Methods A total of 132 FSWs will be recruited and randomly assigned to either the intervention or usual care (control) groups in a multi-centred randomised controlled trial. Based on the resilience framework, this intervention is comprised of six weekly sessions focused on the awareness, expression and management of emotions, identifying roles and personal strengths, and effective problem-solving skills. Complex intervention assessment on both intervention process and effectiveness will be adopted when the primary outcome reduction of sexual risk behaviour and other psychological outcomes include their perceived stress, self-esteem, self-efficacy, coping overall resilience, and psychological distress will be measured at baseline, post-treatment and 3-month post-intervention and differences assessed by ANOVA. The relationship of resilience factors, psychological health and HIV preventive behaviours will be evaluated using structural equation modelling. Discussion It is anticipated that this study will increase our understanding of the relationships between individual resilience attributes, positive adaptation, psychological health and sexual health practices. If successful, this programme will provide an innovative direction for HIV prevention by applying the personal resilience factors to promote both psychological well

  16. Open Evaluation: A Vision for Entirely Transparent Post-Publication Peer Review and Rating for Science

    PubMed Central

    Kriegeskorte, Nikolaus

    2012-01-01

    The two major functions of a scientific publishing system are to provide access to and evaluation of scientific papers. While open access (OA) is becoming a reality, open evaluation (OE), the other side of the coin, has received less attention. Evaluation steers the attention of the scientific community and thus the very course of science. It also influences the use of scientific findings in public policy. The current system of scientific publishing provides only journal prestige as an indication of the quality of new papers and relies on a non-transparent and noisy pre-publication peer-review process, which delays publication by many months on average. Here I propose an OE system, in which papers are evaluated post-publication in an ongoing fashion by means of open peer review and rating. Through signed ratings and reviews, scientists steer the attention of their field and build their reputation. Reviewers are motivated to be objective, because low-quality or self-serving signed evaluations will negatively impact their reputation. A core feature of this proposal is a division of powers between the accumulation of evaluative evidence and the analysis of this evidence by paper evaluation functions (PEFs). PEFs can be freely defined by individuals or groups (e.g., scientific societies) and provide a plurality of perspectives on the scientific literature. Simple PEFs will use averages of ratings, weighting reviewers (e.g., by H-index), and rating scales (e.g., by relevance to a decision process) in different ways. Complex PEFs will use advanced statistical techniques to infer the quality of a paper. Papers with initially promising ratings will be more deeply evaluated. The continual refinement of PEFs in response to attempts by individuals to influence evaluations in their own favor will make the system ungameable. OA and OE together have the power to revolutionize scientific publishing and usher in a new culture of transparency, constructive criticism, and

  17. Open evaluation: a vision for entirely transparent post-publication peer review and rating for science.

    PubMed

    Kriegeskorte, Nikolaus

    2012-01-01

    The two major functions of a scientific publishing system are to provide access to and evaluation of scientific papers. While open access (OA) is becoming a reality, open evaluation (OE), the other side of the coin, has received less attention. Evaluation steers the attention of the scientific community and thus the very course of science. It also influences the use of scientific findings in public policy. The current system of scientific publishing provides only journal prestige as an indication of the quality of new papers and relies on a non-transparent and noisy pre-publication peer-review process, which delays publication by many months on average. Here I propose an OE system, in which papers are evaluated post-publication in an ongoing fashion by means of open peer review and rating. Through signed ratings and reviews, scientists steer the attention of their field and build their reputation. Reviewers are motivated to be objective, because low-quality or self-serving signed evaluations will negatively impact their reputation. A core feature of this proposal is a division of powers between the accumulation of evaluative evidence and the analysis of this evidence by paper evaluation functions (PEFs). PEFs can be freely defined by individuals or groups (e.g., scientific societies) and provide a plurality of perspectives on the scientific literature. Simple PEFs will use averages of ratings, weighting reviewers (e.g., by H-index), and rating scales (e.g., by relevance to a decision process) in different ways. Complex PEFs will use advanced statistical techniques to infer the quality of a paper. Papers with initially promising ratings will be more deeply evaluated. The continual refinement of PEFs in response to attempts by individuals to influence evaluations in their own favor will make the system ungameable. OA and OE together have the power to revolutionize scientific publishing and usher in a new culture of transparency, constructive criticism, and

  18. A Post-Hospital Home Exercise Program Improved Mobility but Increased Falls in Older People: A Randomised Controlled Trial

    PubMed Central

    Sherrington, Catherine; Lord, Stephen R.; Vogler, Constance M.; Close, Jacqueline C. T.; Howard, Kirsten; Dean, Catherine M.; Heller, Gillian Z.; Clemson, Lindy; O'Rourke, Sandra D.; Ramsay, Elisabeth; Barraclough, Elizabeth; Herbert, Robert D.; Cumming, Robert G.

    2014-01-01

    Background Home exercise can prevent falls in the general older community but its impact in people recently discharged from hospital is not known. The study aimed to investigate the effects of a home-based exercise program on falls and mobility among people recently discharged from hospital. Methods and Findings This randomised controlled trial (ACTRN12607000563460) was conducted among 340 older people. Intervention group participants (n = 171) were asked to exercise at home for 15–20 minutes up to 6 times weekly for 12 months. The control group (n = 169) received usual care. Primary outcomes were rate of falls (assessed over 12 months using monthly calendars), performance-based mobility (Lower Extremity Summary Performance Score, range 0–3, at baseline and 12 months, assessor unaware of group allocation) and self-reported ease of mobility task performance (range 0–40, assessed with 12 monthly questionaries). Participants had an average age of 81.2 years (SD 8.0) and 70% had fallen in the past year. Complete primary outcome data were obtained for at least 92% of randomised participants. Participants in the intervention group reported more falls than the control group (177 falls versus 123 falls) during the 12-month study period and this difference was statistically significant (incidence rate ratio 1.43, 95% CI 1.07 to 1.93, p = 0.017). At 12-months, performance-based mobility had improved significantly more in the intervention group than in the control group (between-group difference adjusted for baseline performance 0.13, 95% CI 0.04 to 0.21, p = 0.004). Self-reported ease in undertaking mobility tasks over the 12-month period was not significantly different between the groups (0.49, 95% CI −0.91 to 1.90, p = 0.488). Conclusions An individualised home exercise prescription significantly improved performance-based mobility but significantly increased the rate of falls in older people recently discharged from hospital. Trial Registration

  19. Treating Post-traumatic Stress Disorder in Patients with Multiple Sclerosis: A Randomized Controlled Trial Comparing the Efficacy of Eye Movement Desensitization and Reprocessing and Relaxation Therapy

    PubMed Central

    Carletto, Sara; Borghi, Martina; Bertino, Gabriella; Oliva, Francesco; Cavallo, Marco; Hofmann, Arne; Zennaro, Alessandro; Malucchi, Simona; Ostacoli, Luca

    2016-01-01

    Objective: Multiple Sclerosis (MS) is a demyelinating autoimmune disease that imposes a significant emotional burden with heavy psychosocial consequences. Several studies have investigated the association between MS and mental disorders such as depression and anxiety, and recently researchers have focused also on Post-traumatic Stress Disorder (PTSD). This is the first study that investigates the usefulness of proposing a treatment for PTSD to patients with MS. Methods: A randomized controlled trial with patients with MS diagnosed with PTSD comparing Eye Movement Desensitization and Reprocessing (EMDR; n = 20) and Relaxation Therapy (RT; n = 22). The primary outcome measure was the proportion of participants that no longer meet PTSD diagnosis as measured with Clinician Administered PTSD Scale 6-months after the treatment. Results: The majority of patients were able to overcome their PTSD diagnosis after only 10 therapy sessions. EMDR treatment appears to be more effective than RT in reducing the proportion of patients with MS suffering from PTSD. Both treatments are effective in reducing PTSD severity, anxiety and depression symptoms, and to improve Quality of Life. Conclusion: Although our results can only be considered preliminary, this study suggests that it is essential that PTSD symptoms are detected and that brief and cost-effective interventions to reduce PTSD and associated psychological symptoms are offered to patients, in order to help them to reduce the psychological burden associated with their neurological condition. Trial registration: NCT01743664, https://clinicaltrials.gov/ct2/show/NCT01743664 PMID:27148134

  20. Women's evaluation of abuse and violence care in general practice: a cluster randomised controlled trial (weave)

    PubMed Central

    2010-01-01

    Background Intimate partner abuse (IPA) is a major public health problem with serious implications for the physical and psychosocial wellbeing of women, particularly women of child-bearing age. It is a common, hidden problem in general practice and has been under-researched in this setting. Opportunities for early intervention and support in primary care need to be investigated given the frequency of contact women have with general practice. Despite the high prevalence and health consequences of abuse, there is insufficient evidence for screening in primary care settings. Furthermore, there is little rigorous evidence to guide general practitioners (GPs) in responding to women identified as experiencing partner abuse. This paper describes the design of a trial of a general practice-based intervention consisting of screening for fear of partner with feedback to GPs, training for GPs, brief counselling for women and minimal practice organisational change. It examines the effect on women's quality of life, mental health and safety behaviours. Methods/Design weave is a cluster randomised controlled trial involving 40 general practices in Victoria, Australia. Approximately 500 women (16-50 years) seen by the GP in the previous year are mailed a short lifestyle survey containing an item to screen for IPA. Women who indicate that they were afraid of a partner/ex-partner in the last year and provide contact details are invited to participate. Once baseline data are collected, GPs are randomly assigned to either a group involving healthy relationship and responding to IPA training plus inviting women for up to 6 sessions of counselling or to a group involving basic education and usual care for women. Outcomes will be evaluated by postal survey at 6 and 12 months following delivery of the intervention. There will be an economic evaluation, and process evaluation involving interviews with women and GPs, to inform understanding about implementation and outcomes. Discussion The

  1. Evaluation of an online Diabetes Needs Assessment Tool (DNAT) for health professionals: a randomised controlled trial

    PubMed Central

    2009-01-01

    Background Continuous medical education is traditionally reliant to a large extent on self-directed learning based on individuals' perceived learning priorities. Evidence suggests that this ability to self-assess is limited, and more so in the least competent. Therefore, it may be of benefit to utilise some form of external assessment for this purpose. Many diabetes educational programmes have been introduced, but few have been assessed for their benefit in a systematic manner. As diabetes is an increasingly prevalent disease, methods for the dissemination and understanding of clinical guidelines need to be explored for their effectiveness. This paper describes the study design of a randomised controlled trial to evaluate the effectiveness of using an interactive online Diabetes Needs Assessment Tool (DNAT), that builds a learning curriculum based on identified knowledge gaps, compared with conventional self-directed learning. The study assesses the effect of these interventions on health professionals' knowledge of diabetes management, evaluates the acceptability of this process of learning and self-reported changes in clinical practice as a result of this novel educational process. Methods Following a baseline assessment, participants will be randomised to undergo a 4-month learning period where they will either be given access to the diabetes learning modules alone (control group) or a Diabetes Needs Assessment Tool (DNAT) plus the diabetes learning modules (intervention group). On completion of the DNAT, a personalised learning report will be created for each participant identifying needs alongside individualised recommendations of the most appropriate learning modules to meet those requirements. All participants will complete a Diabetes Knowledge Test before and immediately after the allocated learning and the primary outcome will be the state of knowledge at 4 months. Learners will also be surveyed immediately after the learning period to assess the

  2. The effect of a pre- and post-operative orthogeriatric service on cognitive function in patients with hip fracture. The protocol of the Oslo Orthogeriatrics Trial

    PubMed Central

    2012-01-01

    Background Hip fractures mainly affect older people. It is associated with high morbidity and mortality, and in particular a high frequency of delirium. Incident delirium following hip fracture is associated with an increased risk of dementia in the following months, but it is still not firmly established whether this is an association or a causal relationship. Orthogeriatric units vary with respect to content and timing of the intervention. One main effect of orthogeriatric care may be the prevention of delirium, especially if preoperative and postoperative care are provided. Thus, the aim of Oslo Orthogeriatric Trial, is to assess whether combined preoperative and postoperative orthogeriatric care can reduce the incidence of delirium and improve cognition following hip fracture. Methods/design Inclusion and randomisation will take place in the Emergency Department, as soon as possible after admission. All patients with proximal femur fractures are eligible, irrespective of age, pre-fracture function and accommodation, except if the fracture is caused by a high energy trauma or the patient is terminally ill. The intervention is pre-and post-operative orthogeriatric care delivered on a dedicated acute geriatric ward. The primary outcome measure is a composite endpoint combining the Clinical Dementia Rating Scale (CDR) and the 10 word memory task at four months after surgery. Secondary outcomes comprise incident delirium, length of stay, cognition, mobility, place of residence, activities of daily living and mortality, measured at 4 and 12 months after surgery. We have included 332 patients in the period 17th September 2009 to 5th January 2012. Discussion Our choice of outcome measures and our emphasis of orthogeriatric care in the preoperative as well as the postoperative phase will enable us to provide new knowledge on the impact of orthogeriatric care on cognition. Trials registration ClinicalTrials.gov NCT01009268 PMID:22817102

  3. Post-occupancy evaluation: an environment-behaviour technique for assessing the built environment.

    PubMed

    Cooper, B A; Ahrentzen, S; Hasselkus, B R

    1991-10-01

    This paper reviews the development, structure and process of post-occupancy evaluation (POE) as an environment-behaviour approach to assessing built environments of all sizes and types. It illustrates the use of POEs with three examples from the Health Care sector: The Canadian Hospital Evaluation Program, the Weiss Institute, and 18 independent-living apartment units. A comparison is made between POEs and the approach currently used by occupational therapy (OT) for environmental assessments. Recommendations suggest that OT's approach could be extended and strengthened through 1) incorporating POE methods and existing data from environment-behaviour studies; 2) the use of standard assessment procedures and well-validated measures; and 3) the development of a data bank on OT environmental assessments. PMID:10170863

  4. Assessing the impact of microfinance programming on children: an evaluation from post-tsunami Aceh.

    PubMed

    Stark, Lindsay; Kassim, Nafessa; Sparling, Thalia; Buscher, Dale; Yu, Gary; Boothby, Neil

    2015-04-01

    This paper presents an evaluation of the long-term impact of microfinance programmes on Acehnese children during the post-tsunami recovery. The study, conducted from June to August 2010, examined the impact of microfinance programming six years after the tsunami. The sample consisted of 185 microfinance participants, with a comparison group of 192 individuals who did not participate in microfinance programmes. All respondents were parents, interviewed through a structured survey. The study used four child protection indicators-diet, health, childcare and education-in contrast to traditional repayment rate indicators. The primary results were insignificant with respect to all four child protection indicators, suggesting that, with respect to these indicators, there was no long-term difference between the impact of microfinance on beneficiaries' children and non-beneficiaries' children. These findings signify a need for microfinance actors to move beyond traditional indicators of economic success to evaluate the social changes microfinance programmes are presumed to effect. PMID:25441225

  5. Assessing the impact of microfinance programming on children: an evaluation from post-tsunami Aceh

    PubMed Central

    Stark, Lindsay; Kassim, Nafessa; Sparling, Thalia; Buscher, Dale; Yu, Gary; Boothby, Neil

    2015-01-01

    This paper presents an evaluation of the long-term impact of microfinance programmes on Acehnese children during the post-tsunami recovery. The study, conducted from June to August 2010, examined the impact of microfinance programming six years after the tsunami. The sample consisted of 185 microfinance participants, with a comparison group of 192 individuals who did not participate in microfinance programmes. All respondents were parents, interviewed through a structured survey. The study used four child protection indicators—diet, health, childcare and education—in contrast to traditional repayment rate indicators. The primary results were insignificant with respect to all four child protection indicators, suggesting that, with respect to these indicators, there was no long-term difference between the impact of microfinance on beneficiaries' children and non-beneficiaries' children. These findings signify a need for microfinance actors to move beyond traditional indicators of economic success to evaluate the social changes microfinance programmes are presumed to effect. PMID:25441225

  6. An evaluation of a formative assessment process used on post take ward rounds.

    PubMed

    Caldwell, G

    2013-01-01

    The purpose of clinical training is to develop doctors capable of delivering professional, personal, effective, high quality, safe clinical care with Intelligent Kindness. The processes supporting training must promote development towards excellence. In 2004 a formative assessment process for use on medical post take ward rounds was introduced based on a model of a Driving Instructor and Learner Driver. This process has been evaluated in comparison with the Case based Discussion (CbD) and mini-Cex by 140 of 369 trainees, using online surveys. Ten trainees were interviewed in depth. The majority of trainees reported that this process had helped them more in their development as doctors than the CbD or mini-CEX. Trainees were able to describe positive effects in areas such as diagnosis, prescribing and confidence in their work. In the NHS the assessments are meant to be "trainee driven", however all but one of the trainees stated that they preferred the routine provision of an assessment to having to ask for an assessment. This evaluation of a truly formative assessment process shows that the trainees benefit in their progression towards clinical excellence. Effective formative feedback can be provided on an Acute Medical Unit even within the constraints of busy post take ward rounds. Within a team of Consultants one should be allowed time to develop an extended Clinical Supervisor role. PMID:24364051

  7. Role of Survival Post-Progression in Phase III Trials of Systemic Chemotherapy in Advanced Non-Small-Cell Lung Cancer: A Systematic Review

    PubMed Central

    Hotta, Katsuyuki; Kiura, Katsuyuki; Fujiwara, Yoshiro; Takigawa, Nagio; Hisamoto, Akiko; Ichihara, Eiki; Tabata, Masahiro; Tanimoto, Mitsune

    2011-01-01

    Background In advanced non-small-cell lung cancer (NSCLC), with the increasing number of active compounds available in salvage settings, survival after progression to first-line chemotherapy seems to have improved. A literature survey was conducted to examine whether survival post-progression (SPP) has improved over the years and to what degree SPP correlates with overall survival (OS). Methods and Findings Median progression-free survival (MPFS) time and median survival time (MST) were extracted in phase III trials of first-line chemotherapy for advanced NSCLC. SPP was pragmatically defined as the time interval of MST minus MPFS. The relationship between MPFS and MST was modeled in a linear function. We used the coefficient of determination (r2) to assess the correlation between them. Seventy trials with 145 chemotherapy arms were identified. Overall, median SPP was 4.7 months, and a steady improvement in SPP was observed over the 20 years (9.414-day increase per year; p<0.001) in parallel to the increase in MST (11.253-day increase per year; p<0.001); MPFS improved little (1.863-day increase per year). Overall, a stronger association was observed between MST and SPP (r2 = 0.8917) than MST and MPFS time (r2 = 0.2563), suggesting SPP and MPFS could account for 89% and 25% of the variation in MST, respectively. The association between MST and SPP became closer over the years (r2 = 0.4428, 0.7242, and 0.9081 in 1988–1994, 1995–2001, and 2002–2007, respectively). Conclusions SPP has become more closely associated with OS, potentially because of intensive post-study treatments. Even in advanced NSCLC, a PFS advantage is unlikely to be associated with an OS advantage any longer due to this increasing impact of SPP on OS, and that the prolongation of SPP might limit the original role of OS for assessing true efficacy derived from early-line chemotherapy in future clinical trials. PMID:22114662

  8. Evaluation of Hepatoprotective Effect of Silymarin Among Under Treatment Tuberculosis Patients: A Randomized Clinical Trial.

    PubMed

    Marjani, Majid; Baghaei, Parvaneh; Kazempour Dizaji, Mehdi; Gorji Bayani, Pegah; Fahimi, Fanak; Tabarsi, Payam; Velayati, Ali Akbar

    2016-01-01

    Hepatic toxicity is the most serious adverse effect of anti-tuberculosis drugs. This study was performed to evaluate the efficacy of silymarin as a hepatoprotective herbal agent. In a randomized double blind clinical trial, 70 new cases of pulmonary tuberculosis were divided into two groups. The intervention group was assigned to receive silymarin and the control group received placebo. Tuberculosis was treated by classic regimen consisting isoniazid, rifampin, pyrazinamide and ethambutol. No statistically significant difference was found between the two groups concerning the frequency of drug induced liver injury or mild elevation of liver enzymes. Silymarin was safe without any major side effect. Our results showed no significant hepatoprotective effect of silymarin among patients on tuberculosis treatment. PMID:27610165

  9. Evaluation of Hepatoprotective Effect of Silymarin Among Under Treatment Tuberculosis Patients: A Randomized Clinical Trial

    PubMed Central

    Marjani, Majid; Baghaei, Parvaneh; Kazempour Dizaji, Mehdi; Gorji Bayani, Pegah; Fahimi, Fanak; Tabarsi, Payam; Velayati, Ali Akbar

    2016-01-01

    Abstract: Hepatic toxicity is the most serious adverse effect of anti-tuberculosis drugs. This study was performed to evaluate the efficacy of silymarin as a hepatoprotective herbal agent. In a randomized double blind clinical trial, 70 new cases of pulmonary tuberculosis were divided into two groups. The intervention group was assigned to receive silymarin and the control group received placebo. Tuberculosis was treated by classic regimen consisting isoniazid, rifampin, pyrazinamide and ethambutol. No statistically significant difference was found between the two groups concerning the frequency of drug induced liver injury or mild elevation of liver enzymes. Silymarin was safe without any major side effect. Our results showed no significant hepatoprotective effect of silymarin among patients on tuberculosis treatment. PMID:27610165

  10. Two preclinical tests to evaluate anticancer activity and to help validate drug candidates for clinical trials

    PubMed Central

    López-Lázaro, Miguel

    2015-01-01

    Current approaches to assessing preclinical anticancer activity do not reliably predict drug efficacy in cancer patients. Most of the compounds that show remarkable anticancer effects in preclinical models actually fail when tested in clinical trials. We blame these failures on the complexity of the disease and on the limitations of the preclinical tools we require for our research. This manuscript argues that this lack of clinical response may also be caused by poor in vitro and in vivo preclinical designs, in which cancer patients' needs are not fully considered. Then, it proposes two patient-oriented tests to assess in vitro and in vivo anticancer activity and to help validate drug candidates for clinical evaluation. PMID:25859551

  11. Economic Evaluation of a Worksite Obesity Prevention and Intervention Trial among Hotel Workers in Hawaii

    PubMed Central

    Meenan, Richard T.; Vogt, Thomas M.; Williams, Andrew E.; Stevens, Victor J.; Albright, Cheryl L.; Nigg, Claudio

    2010-01-01

    Objective Economic evaluation of Work, Weight, and Wellness (3W), a two-year randomized trial of a weight loss program delivered through Hawaii hotel worksites. Methods Business case analysis from hotel perspective. Program resources were micro-costed (2008 dollars). Program benefits were reduced medical costs, fewer absences, and higher productivity. Primary outcome was discounted 24-month net present value (NPV). Results Control program cost $222K to implement over 24 months ($61 per participant), intervention program cost $1.12M ($334). Including overweight participants (body mass index > 25), discounted control NPV was −$217K; −$1.1M for intervention program. Presenteeism improvement of 50% combined with baseline 10% productivity shortfall required to generate positive 24-month intervention NPV. Conclusions 3W’s positive clinical outcomes did not translate into immediate economic benefit for participating hotels, although modest cost savings were observed in the trial’s second year. PMID:20061889

  12. Quantitative evaluation of muscle synergy models: a single-trial task decoding approach

    PubMed Central

    Delis, Ioannis; Berret, Bastien; Pozzo, Thierry; Panzeri, Stefano

    2013-01-01

    Muscle synergies, i.e., invariant coordinated activations of groups of muscles, have been proposed as building blocks that the central nervous system (CNS) uses to construct the patterns of muscle activity utilized for executing movements. Several efficient dimensionality reduction algorithms that extract putative synergies from electromyographic (EMG) signals have been developed. Typically, the quality of synergy decompositions is assessed by computing the Variance Accounted For (VAF). Yet, little is known about the extent to which the combination of those synergies encodes task-discriminating variations of muscle activity in individual trials. To address this question, here we conceive and develop a novel computational framework to evaluate muscle synergy decompositions in task space. Unlike previous methods considering the total variance of muscle patterns (VAF based metrics), our approach focuses on variance discriminating execution of different tasks. The procedure is based on single-trial task decoding from muscle synergy activation features. The task decoding based metric evaluates quantitatively the mapping between synergy recruitment and task identification and automatically determines the minimal number of synergies that captures all the task-discriminating variability in the synergy activations. In this paper, we first validate the method on plausibly simulated EMG datasets. We then show that it can be applied to different types of muscle synergy decomposition and illustrate its applicability to real data by using it for the analysis of EMG recordings during an arm pointing task. We find that time-varying and synchronous synergies with similar number of parameters are equally efficient in task decoding, suggesting that in this experimental paradigm they are equally valid representations of muscle synergies. Overall, these findings stress the effectiveness of the decoding metric in systematically assessing muscle synergy decompositions in task space. PMID

  13. Development and implementation of the Baltimore healthy carry-outs feasibility trial: process evaluation results

    PubMed Central

    2013-01-01

    Background Prepared food sources, including fast food restaurants and carry-outs, are common in low-income urban areas. These establishments provide foods high in calories, sugar, fat, and sodium. The aims of the study were to (1) describe the development and implementation of a carry-out intervention to provide and promote healthy food choices in prepared food sources, and (2) to assess its feasibility through a process evaluation. Methods To promote healthy eating in this setting, a culturally appropriate intervention was developed based on formative research from direct observation, interviews and focus groups. We implemented a 7-month feasibility trial in 8 carry-outs (4 intervention and 4 comparison) in low-income neighborhoods in Baltimore, MD. The trial included three phases: 1) Improving menu boards and labeling to promote healthier items; 2) Promoting healthy sides and beverages and introducing new items; and 3) Introducing affordable healthier combo meals and improving food preparation methods. A process evaluation was conducted to assess intervention reach, dose received, and fidelity using sales receipts, carry-out visit observations, and an intervention exposure assessment. Results On average, Baltimore Healthy Carry-outs (BHC) increased customer reach at intervention carry-outs; purchases increased by 36.8% at the end of the study compared to baseline. Additionally, menu boards and labels were seen by 100.0% and 84.2% of individuals (n = 101), respectively, at study completion compared to baseline. Customers reported purchasing specific foods due to the presence of a photo on the menu board (65.3%) or menu labeling (42.6%), suggesting moderate to high dose received. Promoted entrée availability and revised menu and poster presence all demonstrated high fidelity and feasibility. Conclusions The results suggest that BHC is a culturally acceptable intervention. The program was also immediately adopted by the Baltimore City Food Policy Initiative as

  14. Health-related quality of life in survivors of stage I-II breast cancer: randomized trial of post-operative conventional radiotherapy and hypofractionated tomotherapy

    PubMed Central

    2012-01-01

    Background Health-related quality of life (HRQOL) assessment is a key component of clinical oncology trials. However, few breast cancer trials comparing adjuvant conventional radiotherapy (CR) and hypofractionated tomotherapy (TT) have investigated HRQOL. We compared HRQOL in stage I-II breast cancer patients who were randomized to receive either CR or TT. Tomotherapy uses an integrated computed tomography scanner to improve treatment accuracy, aiming to reduce the adverse effects of radiotherapy. Methods A total of 121 stage I–II breast cancer patients who had undergone breast conserving surgery (BCS) or mastectomy (MA) were randomly assigned to receive either CR or TT. CR patients received 25 × 2 Gy over 5 weeks, and BCS patients also received a sequential boost of 8 × 2 Gy over 2 weeks. TT patients received 15 × 2.8 Gy over 3 weeks, and BCS patients also received a simultaneous integrated boost of 15 × 0.6 Gy over 3 weeks. Patients completed the EORTC QLQ-C30 and BR23 questionnaires. The mean score (± standard error) was calculated at baseline, the end of radiotherapy, and at 3 months and 1, 2, and 3 years post-radiotherapy. Data were analyzed by the 'intention-to-treat' principle. Results On the last day of radiotherapy, patients in both treatment arms had decreased global health status and functioning scores; increased fatigue (clinically meaningful in both treatment arms), nausea and vomiting, and constipation; decreased arm symptoms; clinically meaningful increased breast symptoms in CR patients and systemic side effects in TT patients; and slightly decreased body image and future perspective. At 3 months post-radiotherapy, TT patients had a clinically significant increase in role- and social-functioning scores and a clinically significant decrease in fatigue. The post-radiotherapy physical-, cognitive- and emotional-functioning scores improved faster in TT patients than CR patients. TT patients also had a better long-term recovery

  15. Haemoconcentration, renal function, and post-discharge outcomes among patients hospitalized for heart failure with reduced ejection fraction: insights from the EVEREST trial

    PubMed Central

    Greene, Stephen J.; Gheorghiade, Mihai; Vaduganathan, Muthiah; Ambrosy, Andrew P.; Mentz, Robert J.; Subacius, Haris; Maggioni, Aldo P.; Nodari, Savina; Konstam, Marvin A.; Butler, Javed; Filippatos, Gerasimos

    2013-01-01

    Aims Haemoconcentration has been studied as a marker of decongestion in patients with hospitalization for heart failure (HHF). We describe the relationship between haemoconcentration, worsening renal function, post-discharge outcomes, and clinical and laboratory markers of congestion in a large multinational cohort of patients with HHF. Methods and results In 1684 patients with HHF with ejection fraction (EF) ≤40% assigned to the placebo arm of the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial, absolute in-hospital haematocrit change was calculated as the change between baseline and discharge or day 7 (whichever occurred first). Patient characteristics, changes in renal function, and outcomes over a median follow-up of 9.9 months were compared by in-hospital haematocrit change. Overall, 26% of patients had evidence of haemoconcentration (i.e. ≥3% absolute increase in haematocrit). Patients with greater increases in haematocrit tended to have better baseline renal function. Haemoconcentration correlated with greater risk of in-hospital worsening renal function, but renal parameters generally returned to baseline within 4 weeks post-discharge. Patients with haemoconcentration were less likely to have clinical congestion at discharge, and experienced greater in-hospital decreases in body weight and natriuretic peptide levels. After adjustment for baseline clinical risk factors, every 5% increase of in-hospital haematocrit change was associated with a decreased risk of all-cause death [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.70–0.95]. Haematocrit change was also associated with decreased cardiovascular mortality or heart failure (HF) hospitalization at ≤100 days post-randomization (HR 0.73, 95% CI 0.71–0.76). Conclusion In this large cohort of patients with HHF with reduced EF, haemoconcentration was associated with greater improvements in congestion and decreased mortality and HF re

  16. Evaluating predictive screening for children's post-injury mental health: New data and a replication

    PubMed Central

    Kassam-Adams, Nancy; Marsac, Meghan L.; García-España, J. Felipe; Winston, Flaura

    2015-01-01

    Background Recommended approaches for secondary prevention of posttrauma mental health difficulties in children require empirically sound predictive screening to determine which children require more intensive monitoring or targeted intervention. Although there are several promising screening tools for injured children, none has emerged as the gold standard, and little replication data are available regarding their performance. Objective To evaluate a predictive screening protocol for risk of later posttraumatic stress (PTS) and depression outcomes and address a crucial lack of replication studies by examining performance of two previously published screening tools (Screening Tool for Early Predictors of PTSD [STEPP] and Child Trauma Screening Questionnaire [CTSQ]). Method The study enrolled 290 children hospitalized after acute injury. A three-part screening protocol, including acute PTS and depression symptoms and other empirically derived risk factors, was administered in hospital as part of a stepped care study. PTS and depression symptoms and health-related quality of life (HRQoL) were assessed 6 months post-injury. Results The screening protocol demonstrated excellent sensitivity (1.00) and good specificity (0.73) for prediction of 6-month PTS, moderate sensitivity (0.64) and good specificity (0.74) for 6-month depression, and excellent negative predictive value for both outcomes. Among children screening at risk, HRQoL was poorer at 6 months post-injury. Replication analyses found predictive utility (sensitivity and specificity) was low for the STEPP and moderate for the CTSQ. Conclusions This study provides additional evidence that early post-injury screening could identify children at higher risk for persistent PTS symptoms and limited support for predicting post-injury depression. Findings support acute PTS symptoms as key early risk markers. The predictive value of a negative screening result (i.e., knowing who is not at risk) may be especially important

  17. Ultrasound-Guided Transversus Abdominis Plane Block versus Continuous Wound Infusion for Post-Caesarean Analgesia: A Randomized Trial

    PubMed Central

    Chandon, Michel; Bonnet, Agnès; Burg, Yannick; Barnichon, Carole; DesMesnards-Smaja, Véronique; Sitbon, Brigitte; Foiret, Christine; Dreyfus, Jean-François; Rahmani, Jamil; Laloë, Pierre-Antoine; Fischler, Marc; Le Guen, Morgan

    2014-01-01

    Objective To compare the analgesic effect of ultrasound-guided Transversus Abdominis Plane (TAP) block versus Continuous Wound Infusion (CWI) with levobupivacaine after caesarean delivery. Methods We recruited parturients undergoing elective caesareans for this multicenter study. Following written informed consent, they received a spinal anaesthetic without intrathecal morphine for their caesarean section. The postoperative analgesia was randomized to either a bilateral ultrasound guided TAP block (levobupivicaine = 150 mg) or a CWI through an elastomeric pump for 48 hours (levobupivacaine = 150 mg the first day and 12.5 mg/h thereafter). Every woman received regular analgesics along with oral morphine if required. The primary outcome was comparison of the 48-hour area under the curve (AUC) pain scores. Secondary outcomes included morphine consumption, adverse events, and persistent pain one month postoperatively. Results Recruitment of 120 women was planned but the study was prematurely terminated due to the occurrence of generalized seizures in one patient of the TAP group. By then, 36 patients with TAP and 29 with CWI had completed the study. AUC of pain at rest and during mobilization were not significantly different: 50 [22.5–80] in TAP versus 50 [27.5–130] in CWI (P = 0.4) and 190 [130–240] versus 160 [112.5–247.5] (P = 0.5), respectively. Morphine consumption (0 [0–20] mg in the TAP group and 10 [0–32.5] mg in the CWI group (P = 0.09)) and persistent pain at one month were similar in both groups (respectively 29.6% and 26.6% (P = 0.73)). Conclusion In cases of morphine-free spinal anesthesia for cesarean delivery, no difference between TAP block and CWI for postoperative analgesia was suggested. TAP block may induce seizures in this specific context. Consequently, such a technique after a caesarean section cannot be recommended. Trial Registration ClinicalTrials.gov NCT01151943 PMID:25093663

  18. What is the ideal dose and power output of low-level laser therapy (810 nm) on muscle performance and post-exercise recovery? Study protocol for a double-blind, randomized, placebo-controlled trial

    PubMed Central

    2014-01-01

    Background Recent studies involving phototherapy applied prior to exercise have demonstrated positive results regarding the attenuation of muscle fatigue and the expression of biochemical markers associated with recovery. However, a number of factors remain unknown, such as the ideal dose and application parameters, mechanisms of action and long-term effects on muscle recovery. The aims of the proposed project are to evaluate the long-term effects of low-level laser therapy on post-exercise musculoskeletal recovery and identify the best dose andapplication power/irradiation time. Design and methods A double-blind, randomized, placebo-controlled clinical trial with be conducted. After fulfilling the eligibility criteria, 28 high-performance athletes will be allocated to four groups of seven volunteers each. In phase 1, the laser power will be 200 mW and different doses will be tested: Group A (2 J), Group B (6 J), Group C (10 J) and Group D (0 J). In phase 2, the best dose obtained in phase 1 will be used with the same distribution of the volunteers, but with different powers: Group A (100 mW), Group B (200 mW), Group C (400 mW) and Group D (0 mW). The isokinetic test will be performed based on maximum voluntary contraction prior to the application of the laser and after the eccentric contraction protocol, which will also be performed using the isokinetic dynamometer. The following variables related to physical performance will be analyzed: peak torque/maximum voluntary contraction, delayed onset muscle soreness (algometer), biochemical markers of muscle damage, inflammation and oxidative stress. Discussion Our intention, is to determine optimal laser therapy application parameters capable of slowing down the physiological muscle fatigue process, reducing injuries or micro-injuries in skeletal muscle stemming from physical exertion and accelerating post-exercise muscle recovery. We believe that, unlike drug therapy, LLLT has a biphasic dose–response pattern. Trial

  19. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial

    PubMed Central

    Fawzy, Hosam; Elmistekawy, Elsayed; Bonneau, Daniel; Latter, David; Errett, Lee

    2009-01-01

    Background Diffuse microvascular bleeding remains a common problem after cardiac procedures. Systemic use of antifibrinolytic reduces the postoperative blood loss. The purpose of this study was to examine the effectiveness of local application of tranexamic acid to reduce blood loss after coronary artery bypass grafting (CABG). Methods Thirty eight patients scheduled for primary isolated coronary artery bypass grafting were included in this double blind, prospective, randomized, placebo controlled study. Tranexamic acid (TA) group (19 patients) received 1 gram of TA diluted in 100 ml normal saline. Placebo group (19 patients) received 100 ml of normal saline only. The solution was purred in the pericardial and mediastinal cavities. Results Both groups were comparable in their baseline demographic and surgical characteristics. During the first 24 hours post-operatively, cumulative blood loss was significantly less in TA group (median of 626 ml) compared to Placebo group (median of 1040 ml) (P = 0.04). There was no significant difference in the post-op Packed RBCs transfusion between both groups (median of one unit in each) (P = 0.82). Significant less platelets transfusion required in TA group (median zero unit) than in placebo group (median 2 units) (P = 0.03). Apart from re-exploration for excessive surgical bleeding in one patient in TA group, no difference was found in morbidity or mortality between both groups. Conclusion Topical application of tranexamic acid in patients undergoing primary coronary artery bypass grafting led to a significant reduction in postoperative blood loss without adding extra risk to the patient. PMID:19538741

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

    PubMed Central

    Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K–12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The researchers asked whether the curricular materials improved students’ understanding of the content more than an alternative set of activities. The field test was conducted in a diverse public high school setting with 145 students who were randomly assigned to a treatment or comparison condition. Findings indicate that students in the treatment condition scored significantly higher on the posttest than did students in the comparison group (effect size: Cohen's d = 0.40). The paper discusses the strengths and limitations of the RCT, the contextual factors that influenced its enactment, and recommendations for others wishing to conduct small-scale rigorous evaluations in educational settings. Our intention is for this paper to serve as a case study for university science faculty members who wish to employ scientifically rigorous evaluations in K–12 settings while limiting the scope and budget of their work. PMID:25452482

  1. A 3-year randomized clinical trial evaluating two different bonded posterior restorations: Amalgam versus resin composite

    PubMed Central

    Kemaloglu, Hande; Pamir, Tijen; Tezel, Huseyin

    2016-01-01

    Objective: To compare the performance and postoperative sensitivity of a posterior resin composite with that of bonded amalgam in 40 (n = 20) large sized cavities and to evaluate whether resin composite could be an alternative for bonded amalgam. Materials and Methods: This was a randomized clinical trial. Twenty patients in need of at least two posterior restorations were recruited. Authors randomly assigned one half of the restorations to receive bonded amalgam and the other half to composite restorations. Forty bonded amalgams (n = 20) and composites (n = 20) were evaluated for their performance on modified-US Public Health Service criteria and postoperative sensitivity using visual analogue scale (VAS) for 36-months. Results: Success rate of this study was 100%. First clinical alterations were rated as Bravo after 1 year in marginal discoloration, marginal adaptation, anatomical form, and surface roughness for both amalgam and composite. At the 3rd year, overall “Bravo” rated restorations were 12 for bonded amalgam and 13 for resin composites. There were no significant differences among the VAS scores of composites and bonded amalgams for all periods (P > 0.05) except for the comparisons at the 3rd year evaluation (P < 0.05). Conclusions: Within the limitation of this study, both resin composite and bonded amalgam were clinically acceptable. Postoperative sensitivity results tend to decrease more in composite restorations rather than amalgams. Therefore, it was concluded that posterior resin composite can be used even in large sized cavities. PMID:27011734

  2. The effects of neuromuscular exercise on medial knee joint load post-arthroscopic partial medial meniscectomy: ‘SCOPEX’ a randomised control trial protocol

    PubMed Central

    2012-01-01

    Background Meniscectomy is a risk factor for knee osteoarthritis, with increased medial joint loading a likely contributor to the development and progression of knee osteoarthritis in this group. Therefore, post-surgical rehabilitation or interventions that reduce medial knee joint loading have the potential to reduce the risk of developing or progressing osteoarthritis. The primary purpose of this randomised, assessor-blind controlled trial is to determine the effects of a home-based, physiotherapist-supervised neuromuscular exercise program on medial knee joint load during functional tasks in people who have recently undergone a partial medial meniscectomy. Methods/design 62 people aged 30–50 years who have undergone an arthroscopic partial medial meniscectomy within the previous 3 to 12 months will be recruited and randomly assigned to a neuromuscular exercise or control group using concealed allocation. The neuromuscular exercise group will attend 8 supervised exercise sessions with a physiotherapist and will perform 6 exercises at home, at least 3 times per week for 12 weeks. The control group will not receive the neuromuscular training program. Blinded assessment will be performed at baseline and immediately following the 12-week intervention. The primary outcomes are change in the peak external knee adduction moment measured by 3-dimensional analysis during normal paced walking and one-leg rise. Secondary outcomes include the change in peak external knee adduction moment during fast pace walking and one-leg hop and change in the knee adduction moment impulse during walking, one-leg rise and one-leg hop, knee and hip muscle strength, electromyographic muscle activation patterns, objective measures of physical function, as well as self-reported measures of physical function and symptoms and additional biomechanical parameters. Discussion The findings from this trial will provide evidence regarding the effect of a home-based, physiotherapist

  3. Field trial to test and evaluate primary tobacco prevention methods in clusters of elementary schools in Barbados.

    PubMed

    Lwegaba, A

    2005-10-01

    To evaluate methods of preventing young children from experimenting with tobacco and to determine cost effectiveness, students (n = 1005) in 31 primary schools, from randomly selected higher grade-levels were recruited into a partially randomized, single blinded controlled trial in which seven groups of schools were randomly assigned to a combination of teaching, leaflet, and drama, in order to modify students' knowledge, attitudes, beliefs and behaviour (KAB). The eighth group (n = 346) with ten schools, distantly separated from the former, was assigned to be the control, but was dropped from comparison analysis for lack of randomness at baseline. The mean, standard deviation and median age of the intervention groups was 9.94 years (0.81), 10.0 years, (n = 669) at baseline; and 10.62 years (0.66), 11.0 years, (n = 397), at 12 months follow-up. In all, 6.6% had ever used tobacco at least once at a median age of seven years. Teaching health education at school when combined with other methods was significantly better at improving KAB. In 2003, after a year post-intervention, the occurrence of experimentation smoking in the last 30 days, dropped from 9.2% to 1.2% (p = 0.00), equivalent to 87% (95% CI 78, 93) reduction in the group exposed to health education compared to none in the leaflet-only group and Numbers Needed to Treat (NNT) = 12.5. Due to its cost-effectiveness (comparable to child immunizations) at BDS dollars 1.89 to 2.89 or US dollars 1 to 1.5 per child contacted and BDS dollars 100 to 140 (US dollars 50 to 70) capital investment in other resources per school, the experience could be utilized routinely in elementary schools. PMID:16459509

  4. Trial watch

    PubMed Central

    Vacchelli, Erika; Eggermont, Alexander; Sautès-Fridman, Catherine; Galon, Jérôme; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    Oncolytic virotherapy is emerging as a promising approach for the treatment of several neoplasms. The term “oncolytic viruses” is generally employed to indicate naturally occurring or genetically engineered attenuated viral particles that cause the demise of malignant cells while sparing their non-transformed counterparts. From a conceptual standpoint, oncolytic viruses differ from so-called “oncotropic viruses” in that only the former are able to kill cancer cells, even though both display a preferential tropism for malignant tissues. Of note, such a specificity can originate at several different steps of the viral cycle, including the entry of virions (transductional specificity) as well as their intracellular survival and replication (post-transcriptional and transcriptional specificity). During the past two decades, a large array of replication-competent and replication-incompetent oncolytic viruses has been developed and engineered to express gene products that would specifically promote the death of infected (cancer) cells. However, contrarily to long-standing beliefs, the antineoplastic activity of oncolytic viruses is not a mere consequence of the cytopathic effect, i.e., the lethal outcome of an intense, productive viral infection, but rather involves the elicitation of an antitumor immune response. In line with this notion, oncolytic viruses genetically modified to drive the local production of immunostimulatory cytokines exert more robust therapeutic effects than their non-engineered counterparts. Moreover, the efficacy of oncolytic virotherapy is significantly improved by some extent of initial immunosuppression (facilitating viral replication and spread) followed by the administration of immunostimulatory molecules (boosting antitumor immune responses). In this Trial Watch, we will discuss the results of recent clinical trials that have evaluated/are evaluating the safety and antineoplastic potential of oncolytic virotherapy. PMID:23894720

  5. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial

    PubMed Central

    Maggioni, Aldo P.; Greene, Stephen J.; Fonarow, Gregg C.; Böhm, Michael; Zannad, Faiez; Solomon, Scott D.; Lewis, Eldrin F.; Baschiera, Fabio; Hua, Tsushung A.; Gimpelewicz, Claudio R.; Lesogor, Anastasia; Gheorghiade, Mihai; Ramos, Silvina; Luna, Alejandra; Miriuka, Santiago; Diez, Mirta; Perna, Eduardo; Luquez, Hugo; Pinna, Jorge Garcia; Castagnino, Jorge; Alvarenga, Pablo; Ibañez, Julio; Blumberg, Eduardo Salmon; Dizeo, Claudio; Guerrero, Rodolfo Ahuad; Schygiel, Pablo; Milesi, Rodolfo; Sosa, Carlos; Hominal, Miguel; Marquez, Lilia Lobo; Poy, Carlos; Hasbani, Eduardo; Vico, Marisa; Fernandez, Alberto; Vita, Nestor; Vanhaecke, Johan; De Keulenaer, Gilles; Striekwold, Harry; Vervoort, Geert; Vrolix, Mathias; Henry, Philippe; Dendale, Paul; Smolders, Walter; Marechal, Patrick; Vandekerckhove, Hans; Oliveira, Mucio; Neuenschwande, Fernando; Reis, Gilmar; Saraiva, Jose; Bodanese, Luiz; Canesin, Manoel; Greco, Oswaldo; Bassan, Roberto; Marino, Roberto Luis; Giannetti, Nadia; Moe, Gordon; Sussex, Bruce; Sheppard, Richard; Huynh, Thao; Stewart, Robert; Haddad, Haissam; Echeverria, Luis; Quintero, Adalberto; Torres, Adriana; Jaramillo, Mónica; Lopez, Mónica; Mendoza, Fernan; Florez, Noel; Cotes, Carlos; Garcia, Magali; Belohlavek, Jan; Hradec, Jaromir; Peterka, Martin; Gregor, Pavel; Monhart, Zdenek; Jansky, Petr; Kettner, Jiri; Reichert, Petr; Spinar, Jindrich; Brabec, Tomas; Hutyra, Martin; Solar, Miroslav; Pietilä, Mikko; Nyman, Kai; Pajari, Risto; Cohen, Ariel; Galinier, Michel; Gosse, Philippe; Livarek, Bernard; Neuder, Yannick; Jourdain, Patrick; Picard, François; Isnard, Richard; Hoppe, Uta; Kaeaeb, Stefan; Rosocha, Stefan; Prondzinsky, Roland; Felix, Stephan; Duengen, Hans-Dirk; Figulla, Hans-Reiner; Fischer, Sven; Behrens, Steffen; Stawowy, Philipp; Kruells-Muench, Juergen; Knebel, Fabian; Nienaber, Christoph; Werner, Dierk; Aron, Wilma; Remppis, Bjoern; Hambrecht, Rainer; Kisters, Klaus; Werner, Nikos; Hoffmann, Stefan; Rossol, Siegbert; Geiss, Ernst; Graf, Kristof; Hamann, Frank; von Scheidt, Wolfgang; Schwinger, Robert; Tebbe, Ulrich; Costard-Jaeckle, Angelika; Lueders, Stephan; Heitzer, Thomas; Leutermann-Oei, Marie-Louise; Braun-Dullaeus, Ruediger; Roehnisch, Jens-Uwe; Muth, Gerhard; Goette, Andreas; Rotter, Achim; Ebelt, Henning; Olbrich, Hans-Georg; Mitrovic, Veselin; Hengstenberg, Christian; Schellong, Sebastian; Zamolyi, Karoly; Vertes, Andras; Matoltsy, Andras; Palinkas, Attila; Herczeg, Bela; Apro, Dezso; Lupkovics, Geza; Tomcsanyi, Janos; Toth, Kalman; Mathur, Atul; Banker, Darshan; Bharani, Anil; Arneja, Jaspal; Khan, Aziz; Gadkari, Milind; Hiremath, Jagdish; Patki, Nitin; Kumbla, Makund; Santosh, M.J.; Ravikishore, A.G.; Abhaichand, Rajpal; Maniyal, Vijayakukmar; Nanjappa, Manjunath; Reddy, P. Naveen; Chockalingam, Kulasekaran; Premchand, Rajendra; Mahajan, Vijay; Lewis, Basil; Wexler, Dov; Shochat, Michael; Keren, Andre; Omary, Muhamad; Katz, Amos; Marmor, Alon; Lembo, Giuseppe; Di Somma, Salvatore; Boccanelli, Alessandro; Barbiero, Mario; Pajes, Giuseppe; De Servi, Stefano; Greco, Dott Cosimo; De Santis, Fernando; Floresta, Agata; Visconti, Luigi Oltrona; Piovaccari, Giancarlo; Cavallini, Claudio; Di Biase, Matteo; Masini, Dott Franco; Vassanelli, Corrado; Viecca, Maurizio; Cangemi, Dott Francesco; Pirelli, Salvatore; Borghi, Claudio; Volpe, Massimo; Branzi, Angelo; Percoco, Dott Giovanni; Severi, Silvia; Santini, Alberto; De Lorenzi, Ettore; Metra, Marco; Zacà, Valerio; Mortara, Andrea; Tranquilino, Francisco P.; Babilonia, Noe A.; Ferrolino, Arthur M.; Manlutac, Benjamin; Dluzniewski, Miroslaw; Dzielinska, Zofia; Nowalany-Kozie, Ewa; Mazurek, Walentyna; Wierzchowiecki, Jerzy; Wysokinski, Andrzej; Szachniewicz, Joanna; Romanowski, Witold; Krauze-Wielicka, Magdalena; Jankowski, Piotr; Berkowski, Piotr; Szelemej, Roman; Kleinrok, Andrzej; Kornacewicz-Jac, Zdzislawa; Vintila, Marius; Vladoianu, Mircea; Militaru, Constantin; Dan, Gheorghe; Dorobantu, Maria; Dragulescu, Stefan; Kostenko, Victor; Vishnevsky, Alexandr; Goloschekin, Boris; Tyrenko, Vadim; Gordienko, Alexander; Kislyak, Oxana; Martsevich, Sergey; Kuchmin, Alexey; Karpov, Yurii; Fomin, Igor; Shvarts, Yury; Orlikova, Olga; Ershova, Olga; Berkovich, Olga; Sitnikova, Maria; Pakhomova, Inna; Boldueva, Svetlana; Tyurina, Tatiana; Simanenkov, Vladimir; Boyarkin, Mikhail; Novikova, Nina; Tereschenko, Sergey; Zadionchenko, Vladimir; Shogenov, Zaur; Gordeev, Ivan; Moiseev, Valentin; Wong, Raymond; Ong, Hean Yee; Le Tan, Ju; Goncalvesova, Eva; Kovar, Frantisek; Skalina, Ivan; Kasperova, Viera; Hojerova, Silvia

    2013-01-01

    Aims The objective of the Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) was to determine whether aliskiren, a direct renin inhibitor, would improve post-discharge outcomes in patients with hospitalization for heart failure (HHF) with reduced ejection fraction. Pre-specified subgroup analyses suggested potential heterogeneity in post-discharge outcomes with aliskiren in patients with and without baseline diabetes mellitus (DM). Methods and results ASTRONAUT included 953 patients without DM (aliskiren 489; placebo 464) and 662 patients with DM (aliskiren 319; placebo 343) (as reported by study investigators). Study endpoints included the first occurrence of cardiovascular death or HHF within 6 and 12 months, all-cause death within 6 and 12 months, and change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 1, 6, and 12 months. Data regarding risk of hyperkalaemia, renal impairment, and hypotension, and changes in additional serum biomarkers were collected. The effect of aliskiren on cardiovascular death or HHF within 6 months (primary endpoint) did not significantly differ by baseline DM status (P = 0.08 for interaction), but reached statistical significance at 12 months (non-DM: HR: 0.80, 95% CI: 0.64–0.99; DM: HR: 1.16, 95% CI: 0.91–1.47; P = 0.03 for interaction). Risk of 12-month all-cause death with aliskiren significantly differed by the presence of baseline DM (non-DM: HR: 0.69, 95% CI: 0.50–0.94; DM: HR: 1.64, 95% CI: 1.15–2.33; P < 0.01 for interaction). Among non-diabetics, aliskiren significantly reduced NT-proBNP through 6 months and plasma troponin I and aldosterone through 12 months, as compared to placebo. Among diabetic patients, aliskiren reduced plasma troponin I and aldosterone relative to placebo through 1 month only. There was a trend towards differing risk of post-baseline potassium ≥6 mmol/L with aliskiren by underlying DM status (non-DM: HR: 1.17, 95% CI: 0.71–1.93; DM: HR: 2.39, 95% CI: 1.30

  6. Evaluation of root external temperature during the application of ultrasound in removal of intraradicular posts.

    PubMed

    Garrido, Angela Delfina Bittencourt; Fonseca, Tabajara Sabbag; Silva-Sousa, Yara Teresinha Correa; Alfredo, Edson; Sousa-Neto, Manoel Damiao

    2007-01-01

    This study evaluated the temperature rise on external root surfaces by simulating the removal of metallic posts by applying ultrasound, with or without refrigeration and at different times. The crowns of 30 healthy maxillary central incisors were removed and the roots were treated endodontically. The prosthetic spaces were prepared and impressions were taken with self-curing acrylic resin. After casting with a copper-aluminum alloy, the posts were blasted with aluminum oxide and cemented with resin cement. The specimens were randomly assigned to three groups according to the time of ultrasonic vibration (30, 60, or 120 seconds) and were subdivided into two groups, those cooled with and without water refrigeration. A thermocouple connected to a digital thermometer was positioned on the root external surface and the maximum temperature was recorded. Data were submitted to ANOVA and Tukey's test. Analysis of the results revealed statistical difference among groups (p < 0.01). Ultrasound (with and without water spray) increased root temperature significantly, reaching values of more than 50 degrees C. The exception was the group that used 30 seconds of ultrasound with refrigeration; root temperature reached 35.4 degrees C, making it the only tested condition that remained below the critical value (50 degrees C). PMID:17333983

  7. Design and evaluation of NEUROBike: a neurorehabilitative platform for bedridden post-stroke patients.

    PubMed

    Monaco, Vito; Galardi, Giuseppe; Coscia, Martina; Martelli, Dario; Micera, Silvestro

    2012-11-01

    Over the past decades, a large number of robotic platforms have been developed which provide rehabilitative treatments aimed at recovering walking abilities in post-stroke patients. Unfortunately, they do not significantly influence patients' performance after three months from the accident. One of the main reasons underlying this result seems to be related to the time of intervention. Specifically, although experimental evidences suggest that early (i.e., first days after the injury) and intense neuro-rehabilitative treatments can significantly favor the functional recovery of post-stroke patients, robots require patients to be verticalized. Consequently, this does not allow them to be treated immediately after the trauma. This paper introduces a new robotic platform, named NEUROBike, designed to provide neuro-rehabilitative treatments to bedridden patients. It was designed to provide an early and well-addressed rehabilitation therapy, in terms of kinesiology, efforts, and fatigue, accounting for exercises functionally related to daily motor tasks. For this purpose, kinematic models of leg-joint angular excursions during both walking and sit-to-stand were developed and implemented in control algorithms leading both passive and active exercises. Finally, a set of pilot tests was carried out to evaluate the performance of the robotic platform on healthy subjects. PMID:22955959

  8. Evaluation of early endoscopic realignment of post-traumatic complete posterior urethral rupture

    PubMed Central

    Abdelsalam, Yaser M; Abdalla, Medhat A; Safwat, Ahmad S; ElGanainy, Ehab O

    2013-01-01

    Introduction: to report our experience with 41 patients treated by early endoscopic realignment of complete post-traumatic rupture urethra. Materials and Methods: The study includes patients presented to our institute, between May 2004 and April 2009, with post-traumatic complete posterior urethral disruption. Preoperative retrograde urethrography, voiding cystourethrography and abdominopelvic CT were performed to evaluate the urethral defect length, the bladder neck competence, the prostate position, and the extent of the pelvic hematoma. Within the first week after trauma, antegrade and retrograde urethroscopy were performed to identify both urethral ends and insert urethral catheter. Patients were followed up by pericatheter retrograde urethrogram monthly postoperatively till catheter removal on disappearance of extravasation. Retrograde urethrography, voiding cystourethrography and urethroscopy were performed 1 month after the removal of the catheter. Follow-up abdominal ultrasound and uroflowmetry monthly till 6 months, bimonthly till 1 year, and every 3 months thereafter were encouraged. Urinary continence and postoperative erectile dysfunction were assessed by direct patient interview. Results: Forty one patients in the age group 17-61 years (mean 37.9) were treated. Patients were followed up for Conclusions: Early endoscopic realignment for complete posterior urethral rupture is a feasible technique with no or minimal intraoperative complications. The technique is successful as the definitive line of therapy in reasonable number of patients and seems to render further future interventions for inevitable urethral stricture easier. PMID:24082438

  9. A comparative evaluation of semen parameters in pre- and post-Hurricane Katrina human population.

    PubMed

    Baran, Caner; Hellstrom, Wayne J; Sikka, Suresh C

    2015-01-01

    A natural disaster leading to accumulation of environmental contaminants may have substantial effects on the male reproductive system. Our aim was to compare and assess semen parameters in a normospermic population residing in the Southern Louisiana, USA area pre- and post-Hurricane Katrina. We retrospectively evaluated semen analyses data (n = 3452) of 1855 patients who attended the Tulane University Andrology/Fertility Clinic between 1999 and 2013. The study inclusion criteria were men whose semen analyses showed ≥ 1.5 ml volume; ≥15 million ml -1 sperm concentration; ≥39 million total sperm count; ≥40% motility; >30% morphology, with an abstinence interval of 2-7 days. After the inclusion criteria applied to the population, 367 normospermic patients were included in the study. Descriptive statistics and group-based analyses were performed to interpret the differences between the pre-Katrina (Group 1, 1999-2005) and the post-Katrina (Group 2, 2006-2013) populations. There were significant differences in motility, morphology, number of white blood cell, immature germ cell count, pH and presence of sperm agglutination, but surprisingly there were no significant differences in sperm count between the two populations. This long-term comparative analysis further documents that a major natural disaster with its accompanied environmental issues can influence certain semen parameters (e.g., motility and morphology) and, by extension, fertility potential of the population of such areas. PMID:25677132

  10. Effects of Reiki on Post-cesarean Delivery Pain, Anxiety, and Hemodynamic Parameters: A Randomized, Controlled Clinical Trial.

    PubMed

    Midilli, Tulay Sagkal; Eser, Ismet

    2015-06-01

    The aim of this study was to investigate the effect of Reiki on pain, anxiety, and hemodynamic parameters on postoperative days 1 and 2 in patients who had undergone cesarean delivery. The design of this study was a randomized, controlled clinical trial. The study took place between February and July 2011 in the Obstetrical Unit at Odemis Public Hospital in Izmir, Turkey. Ninety patients equalized by age and number of births were randomly assigned to either a Reiki group or a control group (a rest without treatment). Treatment applied to both groups in the first 24 and 48 hours after delivery for a total of 30 minutes to 10 identified regions of the body for 3 minutes each. Reiki was applied for 2 days once a day (in the first 24 and 48 hours) within 4-8 hours of the administration of standard analgesic, which was administered intravenously by a nurse. A visual analog scale and the State Anxiety Inventory were used to measure pain and anxiety. Hemodynamic parameters, including blood pressure (systolic and diastolic), pulse and breathing rates, and analgesic requirements also were recorded. Statistically significant differences in pain intensity (p = .000), anxiety value (p = .000), and breathing rate (p = .000) measured over time were found between the two groups. There was a statistically significant difference between the two groups in the time (p = .000) and number (p = .000) of analgesics needed after Reiki application and a rest without treatment. Results showed that Reiki application reduced the intensity of pain, the value of anxiety, and the breathing rate, as well as the need for and number of analgesics. However, it did not affect blood pressure or pulse rate. Reiki application as a nursing intervention is recommended as a pain and anxiety-relieving method in women after cesarean delivery. PMID:26025798

  11. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    PubMed

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation. PMID:22292395

  12. An evaluation of recruitment methods utilized for a clinical trial with periodontal and diabetes enrollment criteria: the Diabetes and Periodontal Therapy Trial

    PubMed Central

    Schoenfeld, Elinor R; Hyman, Leslie; Simpson, Leslie Long; Michalowicz, Bryan; Reddy, Michael; Gelato, Marie; Hou, Wei; Engebretson, Steven P; Hytner, Catherine; Lenton, Pat

    2014-01-01

    Background Diabetes and its complications are a major United States public health concern. Methods The Diabetes and Periodontal Therapy Trial (DPTT) evaluated whether non-surgical treatment of periodontal disease influenced diabetes management among persons with Type 2 diabetes and periodontitis. The aim of this study was to evaluate DPTT’s many recruitment strategies in terms of enrollment success. Results/Conclusion Targeted recruitment strategies were more effective in identifying individuals who met periodontal and diabetes eligibility criteria. Individuals eligible for a baseline visit/enrollment were more often male, had a younger age at diabetes diagnosis, a longer diabetes duration, more often Hispanic and less often African–American. Tracking and evaluating recruitment sources during study enrollment optimized recruitment methods to enroll a diverse participant population based upon gender, race and ethnicity. PMID:25574373

  13. Evaluation of Lay Support in Pregnant women with Social risk (ELSIPS): a randomised controlled trial

    PubMed Central

    2012-01-01

    Background Maternal, neonatal and child health outcomes are worse in families from black and ethnic minority groups and disadvantaged backgrounds. There is little evidence on whether lay support improves maternal and infant outcomes among women with complex social needs within a disadvantaged multi-ethnic population in the United Kingdom (UK). Method/Design The aim of this study is to evaluate a lay Pregnancy Outreach Worker (POW) service for nulliparous women identified as having social risk within a maternity service that is systematically assessing social risks alongside the usual obstetric and medical risks. The study design is a randomised controlled trial (RCT) in nulliparous women assessed as having social risk comparing standard maternity care with the addition of referral to the POW support service. The POWs work alongside community midwifery teams and offer individualised support to women to encourage engagement with services (health and social care) from randomisation (before 28 weeks gestation) until 6 weeks after birth. The primary outcomes have been chosen on the basis that they are linked to maternal and infant health. The two primary outcomes are engagement with antenatal care, assessed by the number of antenatal visits; and maternal depression, assessed using the Edinburgh Postnatal Depression Scale at 8-12 weeks after birth. Secondary outcomes include maternal and neonatal morbidity and mortality, routine child health assessments, including immunisation uptake and breastfeeding at 6 weeks. Other psychological outcomes (self efficacy) and mother-to-infant bonding will also be collected using validated tools. A sample size of 1316 will provide 90% power (at the 5% significance level) to detect increased engagement with antenatal services of 1.5 visits and a reduction of 1.5 in the average EPDS score for women with two or more social risk factors, with power in excess of this for women with any social risk factor. Analysis will be by intention to

  14. Associations between program outcomes and adherence to Social Cognitive Theory tasks: process evaluation of the SHED-IT community weight loss trial for men

    PubMed Central

    2014-01-01

    Background Despite rising international rates of obesity, men remain reluctant to participate in weight loss research. There is a lack of evidence to guide the development of effective weight loss interventions that engage men. The objective of this study was to provide a comprehensive process evaluation of the SHED-IT (Self-Help, Exercise and Diet using Information Technology) weight loss program for men, as delivered in the SHED-IT community weight loss trial, and to identify key components associated with success. Methods In an assessor-blinded randomised controlled trial, 159 overweight and obese men (BMI 25.0-40.0 kg/m2) were randomised to one of two gender-tailored weight loss interventions with no face-to-face contact, or a control group. The interventions were informed by Bandura’s Social Cognitive Theory (SCT) with men encouraged to complete a Support Book containing SCT-based tasks including goal setting, reward setting, creation of social support strategies and self-monitoring of: i) weight, ii) physical activity, and iii) diet. At post-test, compliance with SCT tasks was examined and men also completed a process evaluation questionnaire. Results Both SHED-IT intervention groups demonstrated greater weight loss during the intervention compared to the control, with no difference between intervention groups. Most men engaged with the SCT tasks although compliance declined over time and utilisation of social support networks and reward selection was poor. In a multiple regression model, the number of goals set (β [95% CI] = -0.3 [-0.6, -0.1], p = 0.01) and the number of weight records documented (β [95% CI] = -0.2 [-0.4, -0.0], p = 0.03) independently predicted weight loss. The process evaluation indicated that men found the programs to be supportive, enjoyable and beneficial. Conclusions This process evaluation provides valuable information to inform the development of obesity treatment strategies that engage men. Future studies with

  15. Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Effective programs to help children manage their weight are required. Families for Health focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health V1 showed sustained reductions in overweight after 2 years in a pilot evaluation, but lacks a randomized controlled trial (RCT) evidence base. Methods/design This is a multi-center, investigator-blind RCT, with parallel economic evaluation, with a 12-month follow-up. The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight (≥91st centile BMI) or obese (≥98th centile BMI) from three localities and assigned randomly to Families for Health V2 (60 families) or the usual care control (60 families) groups. Randomization will be stratified by locality (Coventry, Warwickshire, Wolverhampton). Families for Health V2 is a family-based intervention run in a community venue. Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks. The usual care arm will be the usual support provided within each NHS locality. A mixed-methods evaluation will be carried out. Child and parent participants will be assessed at home visits at baseline, 3-month (post-treatment) and 12-month follow-up. The primary outcome measure is the change in the children’s BMI z-scores at 12 months from the baseline. Secondary outcome measures include changes in the children’s waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. The parents’ BMI and mental well-being, family eating/activity, parent–child relationships and parenting style will also be assessed. Economic components will encompass the measurement and valuation of service utilization, including the costs of running Families for Health and usual care, and the EuroQol EQ-5D health outcomes. Cost-effectiveness will be expressed in terms of incremental cost per

  16. Difficulty in detecting discrepancies in a clinical trial report: 260-reader evaluation

    PubMed Central

    Cole, Graham D; Shun-Shin, Matthew J; Nowbar, Alexandra N; Buell, Kevin G; Al-Mayahi, Faisal; Zargaran, David; Mahmood, Saliha; Singh, Bharpoor; Mielewczik, Michael; Francis, Darrel P

    2015-01-01

    Background: Scientific literature can contain errors. Discrepancies, defined as two or more statements or results that cannot both be true, may be a signal of problems with a trial report. In this study, we report how many discrepancies are detected by a large panel of readers examining a trial report containing a large number of discrepancies. Methods: We approached a convenience sample of 343 journal readers in seven countries, and invited them in person to participate in a study. They were asked to examine the tables and figures of one published article for discrepancies. 260 participants agreed, ranging from medical students to professors. The discrepancies they identified were tabulated and counted. There were 39 different discrepancies identified. We evaluated the probability of discrepancy identification, and whether more time spent or greater participant experience as academic authors improved the ability to detect discrepancies. Results: Overall, 95.3% of discrepancies were missed. Most participants (62%) were unable to find any discrepancies. Only 11.5% noticed more than 10% of the discrepancies. More discrepancies were noted by participants who spent more time on the task (Spearman’s ρ = 0.22, P < 0.01), and those with more experience of publishing papers (Spearman’s ρ = 0.13 with number of publications, P = 0.04). Conclusions: Noticing discrepancies is difficult. Most readers miss most discrepancies even when asked specifically to look for them. The probability of a discrepancy evading an individual sensitized reader is 95%, making it important that, when problems are identified after publication, readers are able to communicate with each other. When made aware of discrepancies, the majority of readers support editorial action to correct the scientific record. PMID:26174517

  17. Prospective Multicenter Trial Evaluating Balloon-Catheter Partial-Breast Irradiation for Ductal Carcinoma in Situ

    SciTech Connect

    Abbott, Andrea M.; Portschy, Pamela R.; Lee, Chung; Le, Chap T.; Han, Linda K.; Washington, Tara; Kinney, Michael; Bretzke, Margit; Tuttle, Todd M.

    2013-11-01

    Purpose: To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery. Methods and Materials: We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR). Results: A total of 41 patients (42 breasts) completed treatment in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years. Conclusions: Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended.

  18. Evaluation of biological aerosol stand-off detection at a field trial

    NASA Astrophysics Data System (ADS)

    Jonsson, Per; Elmqvist, Magnus; Gustafsson, Ove; Kullander, Fredrik; Persson, Rolf; Olofsson, Göran; Tjärnhage, Torbjörn; Farsund, Øystein; Haavardsholm, Trym Vegard; Rustad, Gunnar

    2009-09-01

    We have performed a field trial to evaluate technologies for stand-off detection of biological aerosols, both in daytime and at night. Several lidar (light detection and ranging) systems were tested in parallel. We present the results from three different lidar systems; one system for detection and localization of aerosol clouds using elastic backscattering at 1.57 μm, and two systems for detection and classification of aerosol using spectral detection of ultraviolet laser-induced fluorescence (UV LIF) excited at 355 nm. The UV lidar systems were utilizing different technologies for the spectral detection, a photomultiplier tube (PMT) array and an intensified charge-coupled device (ICCD), respectively. During the first week of the field trial, the lidar systems were measuring towards a semi-closed chamber at a distance of 230 m. The chamber was built from two docked standard 20-feet containers with air curtains in the short sides to contain the aerosol inside the chamber. Aerosol was generated inside the semi-closed chamber and monitored by reference equipments, e.g. slit sampler and particle counters. Signatures from several biological warfare agent simulants and interferents were measured at different aerosol concentrations. During the second week the aerosol was released in the air and the reference equipments were located in the centre of the test site. The lidar systems were measuring towards the test site centre at distances of either 230 m or approximately 1 km. In this paper we are presenting results and some preliminary signal processing for discrimination between different types of simulants and interference aerosols.

  19. INTERNAL REPAIR OF PIPELINES REVIEW & EVALUATION OF INTERNAL PIPELINE REPAIR TRIALS REPORT

    SciTech Connect

    Robin Gordon; Bill Bruce; Ian Harris; Dennis Harwig; George Ritter; Bill Mohr; Matt Boring; Nancy Porter; Mike Sullivan; Chris Neary

    2004-09-01

    The two broad categories of fiber-reinforced composite liner repair and deposited weld metal repair technologies were reviewed and evaluated for potential application for internal repair of gas transmission pipelines. Both are used to some extent for other applications and could be further developed for internal, local, structural repair of gas transmission pipelines. Evaluation trials were conducted on pipe sections with simulated corrosion damage repaired with glass fiber-reinforced composite liners, carbon fiber-reinforced composite liners, and weld deposition. Additional un-repaired pipe sections were evaluated in the virgin condition and with simulated damage. Hydrostatic failure pressures for pipe sections repaired with glass fiber-reinforced composite liner were only marginally greater than that of pipe sections without liners, indicating that this type of liner is generally ineffective at restoring the pressure containing capabilities of pipelines. Failure pressure for pipe repaired with carbon fiber-reinforced composite liner was greater than that of the un-repaired pipe section with damage, indicating that this type of liner is effective at restoring the pressure containing capability of pipe. Pipe repaired with weld deposition failed at pressures lower than that of un-repaired pipe in both the virgin and damaged conditions, indicating that this repair technology is less effective at restoring the pressure containing capability of pipe than a carbon fiber-reinforced liner repair. Physical testing indicates that carbon fiber-reinforced liner repair is the most promising technology evaluated to-date. Development of a comprehensive test plan for this process is recommended for use in the next phase of this project.

  20. Space shuttle post-entry and landing analysis. Volume 1: Candidate system evaluations

    NASA Technical Reports Server (NTRS)

    Crawford, B. S.; Duiven, E. M.

    1973-01-01

    The general purpose of this study is to aid in the evaluation and design of multi-sensor navigation schemes proposed for the orbiter. The scope of the effort is limited to the post-entry, energy management, and approach and landing mission phases. One candidate system based on conventional navigation aids is illustrated including two DME (Distance Measuring Equipment) stations and ILS (Instrument Landing System) glide slope and localizer antennas. Some key elements of the system not shown are the onboard IMUs (Inertial Measurement Units), altimeters, and a computer. The latter is programmed to mix together (filter) the IMU data and the externally-derived data. A completely automatic, all-weather landing capability is required. Since no air-breathing engines will be carried on orbital flights, there will be no chance to go around and try again following a missed approach.

  1. Evaluation of an automated sorting process for post-consumer mixed plastic containers. Final report

    SciTech Connect

    Bubenick, D.V.; Faulstich, C.N.

    1993-09-01

    The report provides a detailed evaluation of a pilot-scale automated sorting system for mixed post-consumer plastic containers developed by Rutgers University Center for Plastics Recycling Research (CPRR). The five bottle types considered were natural high-density polyethylene (HDPE), polyvinyl Chloride (PVC), clear polyethylene terephthalate (PET), green polyethylene terephthalate (PET) and opague high gensity polyethylene (HDPE). Three series of tests were performed: single composition, short-term tests, mixed composition, short-term tests, and mixed composition, extended tests. Video taping one of the extended tests proved invaluable in providing insight into diagnosing the system's singulation performance and errors in station recovery. The material handling system had a greater effect than sensor performance on the overall performance of the system.

  2. Evaluating a Brief, Internet-Based Intervention for Co-Occurring Depression and Problematic Alcohol Use in Young People: Protocol for a Randomized Controlled Trial

    PubMed Central

    Teesson, Maree; Kay-Lambkin, Frances; Mills, Katherine L

    2014-01-01

    Background Depression and alcohol misuse represent two of the major causes of disease burden in young adults. These conditions frequently co-occur and this co-occurrence is associated with increased risks and poorer outcomes than either disorder in isolation. Integrated treatments have been shown to be effective, however, there remains a significant gap between those in need of treatment and those receiving it, particularly in young people. The increased availability of Internet-based programs to complement health care presents a unique opportunity in the treatment of these conditions. Objective The objective of our study was to evaluate whether a brief, Internet-based, self-help intervention (the DEAL [DEpression-ALcohol] Project) can be effective in treating co-occurring depression and problematic alcohol use in young people (18-25 years old). Methods The evaluation will take the form of a randomized controlled trial (RCT), comparing the DEAL Project with an attention-control condition (HealthWatch). The RCT will consist of a four-week intervention phase and a 24-week follow-up. It will be entirely Internet-based and open Australia-wide to young people 18 to 25 years old. The primary outcomes will be change in depression symptoms and alcohol use at 5, 12, and 24 weeks post baseline. Secondary outcomes include change in general functioning and quality of life, anxiety/stress symptomatology, and a number of other depression/alcohol related outcomes. Process analysis will also measure engagement across the conditions. Results This study is currently ongoing with preliminary results expected in late 2014. Conclusions This study, to our knowledge, will be the first RCT of a Internet-based treatment for comorbid depression and problematic alcohol use in any age group. If successful, the program represents a novel and innovative approach to addressing the significant harms associated with these conditions and will be an invaluable resource to those not receiving help

  3. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials.

    PubMed

    Vora, J; Seufert, J; Solberg, H; Kinduryte, O; Johansen, T; Hollander, P

    2016-07-01

    We examined insulin antibody formation in patients with type 1 (T1D) or type 2 diabetes (T2D) treated with once-daily insulin degludec (IDeg) or insulin glargine (IGlar) to evaluate the impact of antibody formation on efficacy and safety. Insulin antibodies were measured using subtraction radioimmunoassays in six phase IIIa clinical trials using IDeg (n = 2250) and IGlar (n = 1184). Spearman's correlation coefficient was used to evaluate associations between cross-reacting antibodies and change from baseline glycated haemoglobin (HbA1c) and insulin dose. IDeg- and IGlar-specific antibodies remained low [<1% bound/total radioactivity (B/T)] and with low levels of antibodies cross-reacting with human insulin in patients with T1D (<20% B/T) and T2D (<6% B/T). Spearman's correlation coefficients between insulin antibody levels and change in HbA1c or insulin dose were low in both treatment groups. No clinically meaningful differences in adverse event (AE) rates were observed in patients with >10% B/T or without an absolute increase in antibodies cross-reacting with human insulin. IDeg treatment resulted in few immunogenic responses in patients with T1D and T2D; antibody formation was not associated with change in HbA1c, insulin dose or rates of AEs. PMID:26663320

  4. Imaging techniques in the evaluation of post-infarction function and scar.

    PubMed

    Pozo, Eduardo; Sanz, Javier

    2014-09-01

    Imaging techniques are essential in the clinical evaluation of patients with a myocardial infarction. They are of value for both initial assessment of the ischemic injury and for detection of the subgroup of patients at higher risk of developing cardiovascular events during follow-up. Echocardiography remains the technique of choice for the initial evaluation, owing to its bedside capability to determine strong predictors, such as ventricular volumes, global and regional systolic function, and valvular regurgitation. New techniques for evaluating ventricular mechanics, mainly assessment of ventricular deformation, are revealing important aspects of post-infarction ventricular adaptation. The main alternative to echocardiography is cardiac magnetic resonance imaging. This technique is highly accurate for determining ventricular volumes and ventricular function and has the additional advantage of being able to characterize the myocardium and demonstrate changes associated with the ischemic insult such as necrosis/fibrosis, edema, microvascular obstruction, and intramyocardial hemorrhage. These features not only allow detection and quantification of the infarct size, but also reveal additional characteristics of the scar tissue with prognostic value. PMID:25172072

  5. Evaluation of new UV-cured adhesives and effects of post-cure UV exposure

    NASA Astrophysics Data System (ADS)

    Daly, John G.

    2002-09-01

    Recent developments in adhesives have yielded products well suited for optical applications. Ultraviolet light-cured adhesives can be cured in seconds and are an attractive candidate. Selection of the adhesive properties can be made to achieve optimum performance. For improved alignment stability and reduced stress, low shrinkage adhesives have been needed. New UV-cured adhesives are evaluated with shrinkage values of less than 0.2%. In addition to controlled bonding for alignment stability, the effects of post-cure UV laser exposure (266 nm) are evaluated. Adhesives needed for systems employing UV lasers must consider off-axis exposure that can cause photo-reactive degradation. Relatively low power laser exposure is used as a simulated source for off-axis or scattered irradiation. None of these candidate adhesives are intended for in-the-light path use at 266 nm, but rather as structural adhesives. Evaluation of these candidates included a outgassing screening test that may be employed to select materials.

  6. Continuous intraperitoneal insulin infusion in type 1 diabetes: a 6-year post-trial follow-up

    PubMed Central

    2014-01-01

    Background Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump is a treatment option for patients with type 1 diabetes mellitus (T1DM). Aim of the present study was to describe the long-term course of glycaemic control, complications, health related quality of life (HRQOL) and treatment satisfaction among T1DM patients treated with CIPII. Methods Nineteen patients that participated in a randomized cross-over trial comparing CIPII and subcutaneous (SC) therapy in 2006 were followed until 2012. Laboratory, continuous glucose monitoring, HRQOL and treatment satisfaction measurements were performed at the start of the study, the end of the SC-, the end of the CIPII treatment phase in 2006 and during CIPII therapy in 2012. Linear mixed models were used to calculate estimated values and to test differences between the moments in time. Results In 2012, more time was spent in hyperglycaemia than after the CIPII treatment phase in 2006: 37% (95% CI 29, 44) vs. 55% (95% CI 48, 63), mean difference 19.8% (95% CI 3.0, 36.6). HbA1c was 65 mmol/mol (95% CI 60, 71) at the end of the SC treatment phase in 2006, 58 mmol/mol (95% CI 53, 64) at the end of the CIPII treatment phase and 65 mmol/mol (95% CI 60, 71) in 2012, respectively (p > 0.05). In 2012, the median number of grade 2 hypoglycaemic events per week (1 (95% CI 0, 2)) was still significantly lower than during prior SC therapy (3 (95% CI 2, 4)): mean change -1.8 (95% CI -3.4, -0.4). Treatment satisfaction with CIPII was better than with SC insulin therapy and HRQOL remained stable. Pump or catheter dysfunction of the necessitated re-operation in 7 patients. No mortality was reported. Conclusions After 6 years of CIPII treatment, glycaemic regulation is stable and the number of hypoglycaemic events decreased compared to SC insulin therapy. Treatment satisfaction with CIPII is superior to SC insulin therapy, HRQOL is stable and complications are scarce. CIPII is a safe and effective treatment

  7. Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia

    PubMed Central

    Ngo, Thoai D; Gold, Judy; Edwards, Phil; Vannak, Uk; Sokhey, Ly; Machiyama, Kazuyo; Slaymaker, Emma; Warnock, Ruby; McCarthy, Ona; Free, Caroline

    2015-01-01

    Abstract Objective To assess the effect of a mobile phone-based intervention (mHealth) on post-abortion contraception use by women in Cambodia. Methods The Mobile Technology for Improved Family Planning (MOTIF) study involved women who sought safe abortion services at four Marie Stopes International clinics in Cambodia. We randomly allocated 249 women to a mobile phone-based intervention, which comprised six automated, interactive voice messages with counsellor phone support, as required, whereas 251 women were allocated to a control group receiving standard care. The primary outcome was the self-reported use of an effective contraceptive method, 4 and 12 months after an abortion. Findings Data on effective contraceptive use were available for 431 (86%) participants at 4 months and 328 (66%) at 12 months. Significantly more women in the intervention than the control group reported effective contraception use at 4 months (64% versus 46%, respectively; relative risk, RR: 1.39; 95% confidence interval, CI: 1.17–1.66) but not at 12 months (50% versus 43%, respectively; RR: 1.16; 95% CI: 0.92–1.47). However, significantly more women in the intervention group reported using a long-acting contraceptive method at both follow-up times. There was no significant difference between the groups in repeat pregnancies or abortions at 4 or 12 months. Conclusion Adding a mobile phone-based intervention to abortion care services in Cambodia had a short-term effect on the overall use of any effective contraception, while the use of long-acting contraceptive methods lasted throughout the study period. PMID:26668436

  8. Effects of neuromuscular electrical stimulation combined with effortful swallowing on post-stroke oropharyngeal dysphagia: a randomised controlled trial.

    PubMed

    Park, J-S; Oh, D-H; Hwang, N-K; Lee, J-H

    2016-06-01

    Neuromuscular electrical stimulation (NMES) has been used as a therapeutic intervention for dysphagia. However, the therapeutic effects of NMES lack supporting evidence. In recent years, NMES combined with traditional swallowing therapy has been used to improve functional recovery in patients with post-stroke dysphagia. This study aimed to investigate the effects of effortful swallowing combined with neuromuscular electrical stimulation on hyoid bone movement and swallowing function in stroke patients. Fifty stroke patients with mild dysphagia who were able to swallow against the resistance applied by using NMES and cooperate actively in training were included. This study was designed as a 6-week single-blind, randomised, controlled study. In the experimental group, two pairs of electrodes were placed horizontally in the infrahyoid region to depress the hyoid bone. The NMES intensity was increased gradually until the participants felt a grabbing sensation in their neck and performed an effortful swallow during the stimulation. In the placebo group, the same procedure was followed except for the intensity, which was increased gradually until the participants felt an electrical sensation. All participants underwent this intervention for 30 min per session, 5 sessions per week, for 6 weeks. Videofluoroscopic swallowing studies (VFSS) were carried out before and after the intervention and kinematics of the hyoid bone and swallowing function were analysed based on the VFSS. The experimental group revealed a significant increase in anterior and superior hyoid bone movement and the pharyngeal phase of the swallowing function. This intervention can be used as a novel remedial approach in dysphagic stroke patients. PMID:26969528

  9. Agriculture. Evaluation Report from a Limited School Trial of a Teaching Unit of the High School Geography Project.

    ERIC Educational Resources Information Center

    Richburg, Robert; And Others

    The methodology used in the evaluation of this unit is the same as that described in SO 000 468. Eleven teachers were selected for the field trial thereby involving approximately 300 ninth through twelfth grade students. This unit has five integral activities: 1) Hunger; 2) Agricultural Realm; 3) Interviews with Farmers; 4) Game of Farming; and,…

  10. Japan. Evaluation Report From a Limited School Trial of a Teaching Unit of the High School Geography Project.

    ERIC Educational Resources Information Center

    Kurfman, Dana; And Others

    The school trials of the materials developed by this project yield information relevant to three evaluative criteria: student attitude toward the material, teacher attitude, and the attainment of unit objectives. Eleven teachers were selected involving approximately 300 ninth through twelfth grade students. Estimates of verbal aptitude were…

  11. A Randomized Controlled Trial Evaluation of an After-School Prosocial Behavior Program in an Area of Socioeconomic Disadvantage

    ERIC Educational Resources Information Center

    O'Hare, Liam; Biggart, Andy; Kerr, Karen; Connolly, Paul

    2015-01-01

    A randomized controlled trial was used to evaluate the effects of a prosocial behavior after-school program called Mate-Tricks for 9- and 10-year-old children and their parents living in an area of significant socioeconomic disadvantage. The children were randomly assigned to an intervention (n = 220) or a control group (n = 198). Children were…

  12. [Point on consideration of the clinical trial design and evaluation on the dressing applied to burn wound].

    PubMed

    Yang, Xiaodong

    2012-05-01

    The relevant keypoints needed to be considered in clinical trials of dressing applied to burn wound when claiming for registration is discussed combining with the characteristics of burn wound and the dressing applied to wound surface in order to provide reference for development & clinical evaluation of dressing. PMID:22916480

  13. Using Administrative Data to Evaluate Impacts in a School-Randomized Trial of the 4Rs Program

    ERIC Educational Resources Information Center

    Berg, Juliette; Torrente, Catalina; Aber, J. Lawrence; Jones, Stephanie M.; Brown, Joshua L.

    2010-01-01

    The 4Rs Program (Reading, Writing, Respect and Resolution) is a "dual focus" whole school universal intervention designed to promote literacy development and social-emotional learning, that is currently being rigorously evaluated using a school-randomized trial of 18 elementary schools (9 intervention, 9 control) in New York City. The present…

  14. Myopia Stabilization and Associated Factors Among Participants in the Correction of Myopia Evaluation Trial (COMET)

    PubMed Central

    2013-01-01

    Purpose. To use the Gompertz function to estimate the age and the amount of myopia at stabilization and to evaluate associated factors in the Correction of Myopia Evaluation Trial (COMET) cohort, a large ethnically diverse group of myopic children. Methods. The COMET enrolled 469 ethnically diverse children aged 6 to younger than 12 years with spherical equivalent refraction between −1.25 and −4.50 diopters (D). Noncycloplegic refraction was measured semiannually for 4 years and annually thereafter. Right eye data were fit to individual Gompertz functions in participants with at least 6 years of follow-up and at least seven refraction measurements over 11 years. Function parameters were estimated using a nonlinear least squares procedure. Associated factors were evaluated using linear regression. Results. In total, 426 participants (91%) had valid Gompertz curve fits. The mean (SD) age at myopia stabilization was 15.61 (4.17) years, and the mean (SD) amount of myopia at stabilization was −4.87 (2.01) D. Ethnicity (P < 0.0001) but not sex or the number of myopic parents was associated with the age at stabilization. Ethnicity (P = 0.02) and the number of myopic parents (P = 0.01) but not sex were associated with myopia magnitude at stabilization. At stabilization, African Americans were youngest (mean age, 13.82 years) and had the least myopia (mean, −4.36 D). Participants with two versus no myopic parents had approximately 1.00 D more myopia at stabilization. The age and the amount of myopia at stabilization were correlated (r = −0.60, P < 0.0001). Conclusions. The Gompertz function provides estimates of the age and the amount of myopia at stabilization in an ethnically diverse cohort. These findings should provide guidance on the time course of myopia and on decisions regarding the type and timing of interventions. PMID:24159085

  15. Comparative evaluation of effects of different surface treatment methods on bond strength between fiber post and composite core

    PubMed Central

    Baghaei Yazdi, Najmeh

    2012-01-01

    PURPOSE Debonding of a composite resin core of the fiber post often occurs at the interface between these two materials. The aim of this study was to evaluate the effects of different surface treatment methods on bond strength between fiber posts and composite core. MATERIALS AND METHODS Sixty-four fiber posts were picked in two groups (Hetco and Exacto). Each group was further divided into four subgroups using different surface treatments: 1) silanization; 2) sandblasting; 3) Treatment with 24% H2O2, and 4) no treatment (control group). A cylindrical plexiglass matrix was placed around the post and filled with the core resin composite. Specimens were stored in 5000 thermal cycles between 5℃ and 55℃. Tensile bond strength (TBS) test and evaluation using stereomicroscope were performed on the specimen and the data were analyzed using two-way ANOVA, Post Hoc Scheffe tests and Fisher's Exact Test (α=.05). RESULTS There was a significant difference between the effect of different surface treatments on TBS (P<.001) but different brands of post (P=.743) and interaction between the brand of post and surface treatment (P=.922) had no significant effect on TBS. Both silanization and sandblasting improved the bonding strength of fiber posts to composite resin core, but there were not any significant differences between these groups and control group. CONCLUSION There was not any significant difference between two brands of fiber posts that had been used in this study. Although silanization and sandblasting can improve the TBS, there was not any significant differences between surface treatments used. PMID:22737316

  16. Development of Tools for the pre- and post-Launch Evaluation of VIIRS Atmospheric Products

    NASA Astrophysics Data System (ADS)

    Cureton, G. P.

    2011-12-01

    To facilitate the completion of the product evaluation tasks assigned to the Atmosphere PEATE and associated NPP Science Team, various software tools have been developed. Such tools are intended to provide an accessible path towards visualization of VIIRS swath data (radiometric and atmospheric products), the generation and visualization of globally gridded VIIRS datasets for use in daily and monthly averages, and the analysis of multi-sensor co-located data for cross-validation. In addition to end-user tools, there is also effort made to provide easy-to-use NPP sensor specific software libraries to enable NPP science team members to develop their own tools, without having to learn the minutiae of the NPP data formats. The NPOESS Preparatory Project (NPP) mission will provide a first look at a new generation of science products from U.S. operational polar orbiting Earth observing satellites. The primary focus will be on the production of Sensor Data Record (SDR) and Environmental Data Record (EDR) science products in the Interface Data Processing Segment (IDPS) of the Joint Polar Satellite System (JPSS) Ground System. The NASA NPP Science Teams have been tasked with evaluation of the anticipated operational products from the IDPS within a facility known as the Science Data Segment (SDS). Within the SDS, NASA has established five Product Evaluation and Algorithm Test Elements (PEATEs). The purpose of each PEATE is to enable its associated NPP Science Team to evaluate the operational SDRs and EDRs (both pre-launch and post-launch) from NPP efficiently. The PEATEs are organized into categories including Atmosphere, Land, Ocean, Ozone and Sounder. The Atmosphere PEATE has been established within the Space Science and Engineering Center (SSEC) at the University of Wisconsin-Madison.

  17. A randomized, controlled trial of virtual reality-graded exposure therapy for post-traumatic stress disorder in active duty service members with combat-related post-traumatic stress disorder.

    PubMed

    McLay, Robert N; Wood, Dennis P; Webb-Murphy, Jennifer A; Spira, James L; Wiederhold, Mark D; Pyne, Jeffrey M; Wiederhold, Brenda K

    2011-04-01

    Abstract Virtual reality (VR)-based therapy has emerged as a potentially useful means to treat post-traumatic stress disorder (PTSD), but randomized studies have been lacking for Service Members from Iraq or Afghanistan. This study documents a small, randomized, controlled trial of VR-graded exposure therapy (VR-GET) versus treatment as usual (TAU) for PTSD in Active Duty military personnel with combat-related PTSD. Success was gauged according to whether treatment resulted in a 30 percent or greater improvement in the PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS) after 10 weeks of treatment. Seven of 10 participants improved by 30 percent or greater while in VR-GET, whereas only 1 of the 9 returning participants in TAU showed similar improvement. This is a clinically and statistically significant result (χ(2) = 6.74, p < 0.01, relative risk 3.2). Participants in VR-GET improved an average of 35 points on the CAPS, whereas those in TAU averaged a 9-point improvement (p < 0.05). The results are limited by small size, lack of blinding, a single therapist, and comparison to a relatively uncontrolled usual care condition, but did show VR-GET to be a safe and effective treatment for combat-related PTSD. PMID:21332375

  18. Strengthening patient-centred communication in rural Ugandan health centres: A theory-driven evaluation within a cluster randomized trial

    PubMed Central

    Nayiga, Susan; DiLiberto, Deborah; Taaka, Lilian; Nabirye, Christine; Haaland, Ane; Staedke, Sarah G.

    2014-01-01

    This article describes a theory-driven evaluation of one component of an intervention to improve the quality of health care at Ugandan public health centres. Patient-centred services have been advocated widely, but such approaches have received little attention in Africa. A cluster randomized trial is evaluating population-level outcomes of an intervention with multiple components, including ‘patient-centred services.’ A process evaluation was designed within this trial to articulate and evaluate the implementation and programme theories of the intervention. This article evaluates one hypothesized mechanism of change within the programme theory: the impact of the Patient Centred Services component on health-worker communication. The theory-driven approach extended to evaluation of the outcome measures. The study found that the proximal outcome of patient-centred communication was rated 10 percent higher (p < 0.008) by care seekers consulting with the health workers who were at the intervention health centres compared with those at control health centres. This finding will strengthen interpretation of more distal trial outcomes. PMID:25983612

  19. Brief psychosocial-behavioral intervention with antidepressant reduces post-stroke depression significantly more than usual care with antidepressant: Living Well with Stroke randomized controlled trial

    PubMed Central

    Mitchell, Pamela H.; Veith, Richard C.; Becker, Kyra J.; Buzaitis, Ann; Cain, Kevin C.; Fruin, Michael; Tirschwell, David; Teri, Linda

    2009-01-01

    Background and Purpose Depression following stroke is prevalent, diminishing recovery and quality of life. Brief behavioral intervention, adjunctive to antidepressant therapy has not been well evaluated for long-term efficacy in those with post-stroke depression. Methods 101 clinically depressed ischemic stroke patients within four months of index stroke were randomly assigned to an 8 week brief psychosocial-behavioral intervention plus antidepressant or usual care, including antidepressant. Primary endpoint was reduction in depressive symptom severity at 12 months following entry. Results Hamilton Rating Scale for Depression (HRSD) raw score in the intervention group was significantly lower immediately post-treatment (p = < 0.001) and at 12 months (p = 0.05) compared to controls. Remission (HRSD < 10), was significantly greater immediately post-treatment and at 12 months in the intervention group compared to usual care control. The mean percent decrease (47% ± 26% intervention versus 32% ± 36% control, p = .02) and the mean absolute decrease (-9.2 ± 5.7 intervention versus -6.2 ± 6.4 control, p = 0.023) in HRSD at 12 months were clinically important and statistically significant in the intervention group compared to control. Conclusion A brief psychosocial/behavioral intervention is highly effective in reducing depression in both the short and long term. PMID:19661478

  20. Post-Injection Geophysical Evaluation of the Winding Ridge Site CRADA 98-F012, Final Report

    SciTech Connect

    Connie Lyons; Richard Current; Terry Ackman

    1998-09-16

    Acid mine drainage (AMD) from underground mines is a major environmental problem. The disposal of coal combustion by-products (CCB) is also a major national problem due to the large volumes produced annually and the economics associated with transportation and environmentally safe disposal. The concept of returning large volumes of the CCB to their point of origin, underground mines, and using the typically alkaline and pozzolanic attributes of the waste material for the remediation of AMD has been researched rather diligently during the past few years by various federal and state agencies and universities. As the result, the State of Maryland initiated a full-scale demonstration of this concept in a small, 5-acre, unmapped underground mine located near Friendsville, MD. Through a cooperative agreement between the State of Maryland and the U.S. Department of Energy, several geophysical techniques were evaluated as potential tools for the post-injection evaluation of the underground mine site. Three non-intrusive geophysical surveys, two electromagnetic (EM) techniques and magnetometry, were conducted over the Frazee Mine, which is located on Winding Ridge near Friendsville, MD. The EM surveys were conducted to locate ground water in both mine void and overburden. The presence of magnetite, which is naturally inherent to CCB'S due to the combustion process and essentially transparent in sedimentary rock, provided the reason for using magnetometry to locate the final resting place of the CCB grout.

  1. Evaluating multicenter DTI data in Huntington's disease on site specific effects: An ex post facto approach☆

    PubMed Central

    Müller, Hans-Peter; Grön, Georg; Sprengelmeyer, Reiner; Kassubek, Jan; Ludolph, Albert C.; Hobbs, Nicola; Cole, James; Roos, Raymund A.C.; Duerr, Alexandra; Tabrizi, Sarah J.; Landwehrmeyer, G. Bernhard; Süssmuth, Sigurd D.

    2013-01-01

    Purpose Assessment of the feasibility to average diffusion tensor imaging (DTI) metrics of MRI data acquired in the course of a multicenter study. Materials and methods Sixty-one early stage Huntington's disease patients and forty healthy controls were studied using four different MR scanners at four European sites with acquisition protocols as close as possible to a given standard protocol. The potential and feasibility of averaging data acquired at different sites was evaluated quantitatively by region-of-interest (ROI) based statistical comparisons of coefficients of variation (CV) across centers, as well as by testing for significant group-by-center differences on averaged fractional anisotropy (FA) values between patients and controls. In addition, a whole-brain based statistical between-group comparison was performed using FA maps. Results The ex post facto statistical evaluation of CV and FA-values in a priori defined ROIs showed no differences between sites above chance indicating that data were not systematically biased by center specific factors. Conclusion Averaging FA-maps from DTI data acquired at different study sites and different MR scanner types does not appear to be systematically biased. A suitable recipe for testing on the possibility to pool multicenter DTI data is provided to permit averaging of DTI-derived metrics to differentiate patients from healthy controls at a larger scale. PMID:24179771

  2. Design considerations for a pilot trial using a novel approach for evaluating smoking-cessation medication in methadone-maintained smokers.

    PubMed

    Winhusen, Theresa; Theobald, Jeffrey; Lewis, Daniel

    2016-03-01

    The prevalence of smoking in methadone-maintained (MM) patients is over 80% and smoking-abstinence rates are strikingly low, even with the use of first-line smoking-cessation medications. Research has found that cigarettes increase the reinforcing properties of methadone; this interaction may be an additional, daily, challenge to smoking cessation in MM-smokers. This paper describes a novel approach in which patients who experience a particular barrier to achieving smoking abstinence are selected, and the impact of smoking-cessation medications on the identified barrier is evaluated. This is a 7-week, outpatient, randomized, within-subject, placebo-controlled, crossover trial with a follow-up visit at week 8. MM-smokers, who smoke ≥40% of their total daily cigarettes in the 4-h post-methadone-dosing period, as assessed with a Quitbit electronic cigarette lighter, will be recruited from a methadone program in Cincinnati, Ohio. Eligible participants will be randomized to receive four interventions (nicotine nasal spray (1mg per dose, up to 40 times per day), placebo nicotine nasal spray, varenicline (2mg/day), and varenicline placebo) in one of four orders to mitigate potential order effects. The primary outcome analysis will consist of two sets of statistical analyses, one comparing the effect of nicotine nasal spray to its placebo, and one comparing the effect of varenicline to its placebo, on the proportion of daily cigarettes smoked during the 4-h post-methadone-dosing period. This trial is of interest both as an efficient, precision-medicine-based approach to testing smoking-cessation interventions and as a specific strategy for identifying effective smoking-cessation treatment for MM-smokers. PMID:26944021

  3. Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

    PubMed Central

    Rodgers, Helen; Shaw, Lisa; Price, Christopher; van Wijck, Frederike; Barnes, Michael; Graham, Laura; Ford, Gary; Shackley, Phil; Steen, Nick

    2008-01-01

    Background Following a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear. The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. Methods Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation. Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions : Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group). Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy. Randomisation : A web based central independent randomisation service. Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group. Sample size : 332 participants provide 80% power to detect a 15% difference in treatment successes between

  4. Comparison of Efficacy of Clonidine versus Ondansetron for Prevention of Nausea and Vomiting Post Thyroidectomy: A Double Blind Randomized Controlled Trial

    PubMed Central

    Shilpa, Setty Nagendra Gupta; Hilda, Selvaraj Shanthini

    2015-01-01

    Background and Aim Postoperative nausea vomiting (PONV) is the most common symptom in patients post thyroidectomy. Literature search shows conflicting results regarding use of clonidine in PONV prophylaxis. We undertook this randomized controlled double blind trial to compare the efficacy of clonidine with dexamethasone versus ondansetron with dexamethasone for PONV prophylaxis in these patients. Materials and Methods In this prospective study, 60 consecutive patients posted for thyroidectomy from August 2013 to July 2014, were randomly assigned to two groups, ondansetron (N= 30) (Group A) and clonidine (N= 30) (Group B). Patients received either oral ondansetron 8mg or oral clonidine 150μg as premedication. At the end of surgery, both groups received dexamethasone 8mg intravenously. They were monitored for occurrence of PONV and sore throat for next 24 h. Ramsay sedation scores and total time of analgesia was noted. The primary end point was incidence of PONV in post operative for 24 h. Pearson’s chi square test and Students t tests were performed using SPSS for windows version 20 (SPSS Inc., Chicago, IL). Results Baseline characteristics of patients were comparable. A higher proportion of patients in clonidine group developed PONV than ondansetron (36.7% vs 30%; p=0.03). Clonidine group patients experienced early nausea and vomiting (1-2hrs of postoperative period), compared to ondansetron group patients (6-12 h). Ramsay sedation scores at arrival were higher in clonidine group compared to ondansetron group (2.1 ± 0.3 versus 2.0; p=0.003). Total time of analgesia was higher with use of clonidine than ondansetron (919.5 ± 622 mins versus 642 ± 631 mins; p=0.09). Moderate sore throat was seen in 2 out of 30 patients in both groups. No major adverse events were observed in either group. Conclusion Ondansetron with dexamethasone group was more effective in controlling PONV after thyroidectomy compared to clonidine with dexamethasone group. However, ramsay

  5. Effect of smoking reduction and cessation on the plasma levels of the oxidative stress biomarker glutathione--Post-hoc analysis of data from a smoking cessation trial.

    PubMed

    Mons, Ute; Muscat, Joshua E; Modesto, Jennifer; Richie, John P; Brenner, Hermann

    2016-02-01

    Cigarette smoke contains high concentrations of free radical components that induce oxidative stress. Smoking-induced oxidative stress is thought to contribute to chronic obstructive pulmonary disease, cardiovascular disease and lung cancer through degenerative processes in the lung and other tissues. It is uncertain however whether smoking cessation lowers the burden of oxidative stress. We used data from a randomized controlled cessation trial of 434 current smokers for a post-hoc examination of the effects of smoking cessation on blood plasma levels of total glutathione (tGSH), the most abundant endogenous antioxidant in cells, and total cysteine (tCys), an amino acid and constituent of glutathione. Smoking status was validated based on serum cotinine levels. Multivariate linear mixed models were fitted to examine the association of smoking cessation and change in cigarette consumption with tGSH and tCys. After 12 months follow-up, quitters (n=55) had significantly increased levels of tGSH compared to subjects who continued to smoke (P<0.01). No significant change in tGSH was found for subjects who continued to smoke but reduced their intensity of smoking. No significant effect of smoking cessation or reduction was observed on levels of tCys. These results suggest that smoking cessation but not smoking reduction reduces levels of oxidative stress. PMID:26708755

  6. A randomized controlled effectiveness trial of cognitive behavior therapy for post-traumatic stress disorder in terrorist-affected people in Thailand

    PubMed Central

    BRYANT, RICHARD A.; EKASAWIN, SUPARAT; CHAKRABHAND, SOMCHAI; SUWANMITRI, SOAWALUK; DUANGCHUN, ORAWAN; CHANTALUCKWONG, THANANET

    2011-01-01

    Although cognitive behaviour therapy (CBT) is the treatment of choice for post-traumatic stress disorder (PTSD), there is no evidence of its success with PTSD patients still under direct threat of terrorist attacks. This study reports the first randomized controlled trial of CBT for PTSD terrorist-affected people. Twenty-eight survivors of terrorist attacks in southern Thailand were randomized to 8 sessions of either CBT or treatment as usual (TAU). CBT was modified to accommodate the realistic threats facing patients. There were independent assessments conducted before, immediately after, and 3 months following treatment. Main outcome measures included symptoms of PTSD (PTSD Symptom Scale Interview), depression (Beck Depression Inventory) and complicated grief (Inventory of Complicated Grief). CBT resulted in significantly greater reduction in symptoms, including PTSD, depression, and complicated grief, at follow-up than TAU. Relative to TAU, CBT had stronger effect sizes at follow-up for PTSD, depression, and complicated grief. More patients in the CBT condition (75%) achieved high end-state functioning than participants in the TAU (33%). This preliminary evidence suggests that PTSD, depression, and complicated grief can be effectively treated despite ongoing threats of terrorism. Further, it demonstrates that non-specialist mental health workers in a non-western setting can be efficiently trained in using CBT, and this training can translate into successful treatment gains in trauma-affected individuals. PMID:21991280

  7. A randomized controlled effectiveness trial of cognitive behavior therapy for post-traumatic stress disorder in terrorist-affected people in Thailand.

    PubMed

    Bryant, Richard A; Ekasawin, Suparat; Chakrabhand, Somchai; Suwanmitri, Soawaluk; Duangchun, Orawan; Chantaluckwong, Thananet

    2011-10-01

    Although cognitive behaviour therapy (CBT) is the treatment of choice for post-traumatic stress disorder (PTSD), there is no evidence of its success with PTSD patients still under direct threat of terrorist attacks. This study reports the first randomized controlled trial of CBT for PTSD terrorist-affected people. Twenty-eight survivors of terrorist attacks in southern Thailand were randomized to 8 sessions of either CBT or treatment as usual (TAU). CBT was modified to accommodate the realistic threats facing patients. There were independent assessments conducted before, immediately after, and 3 months following treatment. Main outcome measures included symptoms of PTSD (PTSD Symptom Scale Interview), depression (Beck Depression Inventory) and complicated grief (Inventory of Complicated Grief). CBT resulted in significantly greater reduction in symptoms, including PTSD, depression, and complicated grief, at follow-up than TAU. Relative to TAU, CBT had stronger effect sizes at follow-up for PTSD, depression, and complicated grief. More patients in the CBT condition (75%) achieved high end-state functioning than participants in the TAU (33%). This preliminary evidence suggests that PTSD, depression, and complicated grief can be effectively treated despite ongoing threats of terrorism. Further, it demonstrates that non-specialist mental health workers in a non-western setting can be efficiently trained in using CBT, and this training can translate into successful treatment gains in trauma-affected individuals. PMID:21991280

  8. Evaluation of the Department for Education School Exclusion Trial. Research Briefing No. 1

    ERIC Educational Resources Information Center

    Rogers, Lynne; Hallam, Susan

    2013-01-01

    The Department for Education is running a three-year school exclusion trial, which started in autumn 2011 and continues until July 2014. The trial sees schools taking on responsibility for placing permanently excluded pupils in alternative provision and funding the placements from money devolved from.

  9. Evaluating the Ozioma cancer news service: A community randomized trial in 24 U.S. cities

    PubMed Central

    Caburnay, Charlene A.; Luke, Douglas A.; Cameron, Glen T.; Cohen, Elisia L.; Fu, Qiang; Lai, Choi L.; Stemmle, Jonathan; Paulen, Melissa; McDaniels-Jackson, Lillie; Kreuter, Matthew W.

    2012-01-01

    Objective This community randomized trial evaluated effects of the Ozioma News Service on the amount and quality of cancer coverage in Black weekly newspapers in 24 U.S. cities. Method We created and operated Ozioma, the first cancer information news service specifically for Black newspapers. Over 21 months, Ozioma developed community- and race-specific cancer news releases for each of 12 Black weekly newspapers in intervention communities. Cancer coverage in these papers was tracked before and during the intervention and compared to 12 Black newspapers in control communities. Results From 2004-2007, we coded 9,257 health and cancer stories from 3,178 newspaper issues. Intervention newspapers published approximately 4 times the expected number of cancer stories compared to control newspapers (p12&21mo<.01), and also saw an increase in graphics (p12&21mo<.01), local relevance (p12mo=.01), and personal mobilization (p12mo<.10). However, this increased coverage supplanted other health topics and had smaller graphics (NS), had less community mobilization (p21mo=.01), and less likely to be from a local source (NS). Conclusion Providing news releases with localized and race-specific features to minority-serving media outlets can increase the quantity of cancer coverage. Results are mixed for the journalistic and public health quality of this increased cancer coverage in Black newspapers. PMID:22546317

  10. Evaluating the Accuracy of Results for Teacher Implemented Trial-Based Functional Analyses.

    PubMed

    Rispoli, Mandy; Ninci, Jennifer; Burke, Mack D; Zaini, Samar; Hatton, Heather; Sanchez, Lisa

    2015-09-01

    Trial-based functional analysis (TBFA) allows for the systematic and experimental assessment of challenging behavior in applied settings. The purposes of this study were to evaluate a professional development package focused on training three Head Start teachers to conduct TBFAs with fidelity during ongoing classroom routines. To assess the accuracy of the TBFA results, the effects of a function-based intervention derived from the TBFA were compared with the effects of a non-function-based intervention. Data were collected on child challenging behavior and appropriate communication. An A-B-A-C-D design was utilized in which A represented baseline, and B and C consisted of either function-based or non-function-based interventions counterbalanced across participants, and D represented teacher implementation of the most effective intervention. Results showed that the function-based intervention produced greater decreases in challenging behavior and greater increases in appropriate communication than the non-function-based intervention for all three children. PMID:26069219

  11. A clinical trial evaluating prophylactic and therapeutic antibiotic use on health and performance of preweaned calves.

    PubMed

    Berge, A C B; Lindeque, P; Moore, D A; Sischo, W M

    2005-06-01

    The objective of this clinical trial was to evaluate the influence of prophylactic and therapeutic antibiotics on health and performance in preweaned dairy calves on a calf ranch. One hundred twenty 1-d-old calves were enrolled into 3 management systems for antibiotic use and raised until 4 wk of age. Sixty calves were not eligible to receive prophylactic or therapeutic antibiotics. Thirty calves were eligible to receive individual antibiotic treatment for disease, but no prophylactic antibiotics in milk replacer. The remaining 30 calves received milk replacer medicated with neomycin and tetracycline HCl, and could be treated with antibiotics. Health status and treatments were monitored and recorded daily. The primary study outcomes were weight gain, morbidity, and mortality. The most important factor associated with morbidity and mortality was passive immune transfer through colostrum. In-feed antibiotics delayed onset of morbidity, decreased overall morbidity, and increased weight gain. Nonantibiotic therapies for clinical disease were associated with increased mortality and morbidity compared with antibiotic treatments. The study has shown that minimizing or eliminating the use of antibiotics in the feed requires measures to ensure adequate passive transfer of immunity, but that in the face of inadequate passive transfer of immunity, animal welfare may be endangered by replacing medicated milk replacer with nonmedicated milk replacer, and therapeutic antibiotics with nonantibiotic alternatives. PMID:15905446

  12. Evaluation of post-tensioning of a curved continuous girder using long-gauge fiber optic sensors

    NASA Astrophysics Data System (ADS)

    Abdel-Jaber, Hiba; Glisic, Branko

    2014-03-01

    Streicker Bridge is a pedestrian bridge on the Princeton University campus. It consists of a main span and four curved continuous girders (legs). The main span and the southeast leg of the bridge are equipped with fiber optic strain and temperature sensors, allowing the bridge to also function as an on-campus laboratory for the Structural Health Monitoring research group. Parallel sensors were embedded at critical cross-sections in the deck prior to the pouring of concrete. The deck of the southeast leg experienced early age cracking within a few days of concrete pouring, which was detected by the strain sensors. Post-tensioning was then performed and it is assumed that it closed off the cracks. Evaluation of post-tensioning forces is complex due to the existence of the cracks, and this paper researches a procedure to estimate the post-tensioning forces at cracked and uncracked locations. The obtained post-tensioning forces were compared to design forces and conclusions regarding the status of post-tensioning were made. This is important as it gives information on the actual health condition and performance of the structure. It also provides information on the safety of the structure. The objective of this paper is to present a methodology for the evaluation of the post-tensioning force along the deck based on strain measurements. The monitoring system, results, data analysis method, and conclusions regarding the bridge health condition and performance are presented in this paper.

  13. Understanding the Canadian adult CT head rule trial: use of the theoretical domains framework for process evaluation

    PubMed Central

    2013-01-01

    Background The Canadian CT Head Rule was prospectively derived and validated to assist clinicians with diagnostic decision-making regarding the use of computed tomography (CT) in adult patients with minor head injury. A recent intervention trial failed to demonstrate a decrease in the rate of head CTs following implementation of the rule in Canadian emergency departments. Yet, the same intervention, which included a one-hour educational session and reminders at the point of requisition, was successful in reducing cervical spine imaging rates in the same emergency departments. The reason for the varied effect of the intervention across these two behaviours is unclear. There is an increasing appreciation for the use of theory to conduct process evaluations to better understand how strategies are linked with outcomes in implementation trials. The Theoretical Domains Framework (TDF) has been used to explore health professional behaviour and to design behaviour change interventions but, to date, has not been used to guide a theory-based process evaluation. In this proof of concept study, we explored whether the TDF could be used to guide a retrospective process evaluation to better understand emergency physicians’ responses to the interventions employed in the Canadian CT Head Rule trial. Methods A semi-structured interview guide, based on the 12 domains from the TDF, was used to conduct telephone interviews with project leads and physician participants from the intervention sites in the Canadian CT Head Rule trial. Two reviewers independently coded the anonymised interview transcripts using the TDF as a coding framework. Relevant domains were identified by: the presence of conflicting beliefs within a domain; the frequency of beliefs; and the likely strength of the impact of a belief on the behaviour. Results Eight physicians from four of the intervention sites in the Canadian CT Head Rule trial participated in the interviews. Barriers likely to assist with

  14. Clinical Efficacy and Safety of Pamidronate Therapy on Bone Mass Density in Early Post-Renal Transplant Period: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Wang, Zijie; Han, Zhijian; Tao, Jun; Lu, Pei; Liu, Xuzhong; Wang, Jun; Wu, Bian; Huang, Zhengkai; Yin, Changjun; Tan, Ruoyun; Gu, Min

    2014-01-01

    Introduction The overall effect of pamidronate on bone mass density (BMD) in the early renal transplant period varies considerably among studies. The effects of pamidronate on graft function have not been determined. Materials and Methods A comprehensive search was conducted in PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL) and Embase independently by two authors. Randomized controlled trials of pamidronate evaluating bone loss in the first year of renal transplantation were included. Methods reported in the “Cochrane Handbook for Systematic Reviews of Interventions 5.0.2” were used to evaluate changes of lumbar spine and femoral neck BMD, and serum creatinine, calcium and intact parathyroid hormone (iPTH) levels. Fixed or random effect models were used as appropriate. Results Six randomized trials evaluating 281 patients were identified. One hundred forty-four were treated with pamidronate and 137 were control patients. Administration of pamidronate was associated with significant reduction of bone loss in the lumbar spine, compared to the control group (standardized mean difference (SMD)  = 24.62 [16.25, 32.99]). There was no difference between the pamidronate treated and control femoral neck BMD (SMD  = 3.53 [−1.84, 8.90]). A significant increase in the serum creatinine level of the intervention group was seen, compared to the control group. The serum calcium and iPTH of the pamidronate and control groups were not different after 1 year (serum creatinine: SMD  = −3.101 [−5.33, −0.89]; serum calcium: SMD  = 2.18 [−0.8, 5.16]; serum iPTH: SMD  = 0.06 [−0.19, 0.31]). Heterogeneity was low for serum calcium and iPTH and high for serum creatinine. Conclusions This meta-analysis demonstrated the beneficial clinical efficacy of pamidronate on BMD with no association with any alteration in graft function during the first year of renal transplantation. Significant heterogeneity precludes the conclusion of the

  15. COLLABORATIVE EVALUATION OF A HIGH SCHOOL PREVENTION CURRICULUM: HOW METHODS OF COLLABORATIVE EVALUATION ENHANCED A RANDOMIZED CONTROL TRIAL TO INFORM PROGRAM IMPROVEMENT

    PubMed Central

    Wyrick, David L.; Milroy, Jeffrey J.

    2012-01-01

    Blending high-quality and rigorous research with pure evaluation practice can often be best accomplished through thoughtful collaboration. The evaluation of a high school drug prevention program (All Stars Senior) is an example of how perceived competing purposes and methodologies can coexist to investigate formative and summative outcome variables that can be used for program improvement. Throughout this project there were many examples of client learning from evaluator and evaluator learning from client. This article presents convincing evidence that collaborative evaluation can improve the design, implementation, and findings of the randomized control trial. Throughout this paper, we discuss many examples of good science, good evaluation, and other practical benefits of practicing collaborative evaluation. Ultimately, the authors created the term pre-formative evaluation to describe the period prior to data collection and before program implementation, when collaborative evaluation can inform program improvement. PMID:22391463

  16. Design and Organization of the Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT) Trial: a factorial trial evaluating the effects of corticosteroids, glucose control, and depth-of-anesthesia on perioperative inflammation and morbidity from major non-cardiac surgery

    PubMed Central

    2010-01-01

    Background The perioperative period is characterized by an intense inflammatory response. Perioperative inflammation promotes postoperative morbidity and increases mortality. Blunting the inflammatory response to surgical trauma might thus improve perioperative outcomes. We are studying three interventions that potentially modulate perioperative inflammation: corticosteroids, tight glucose control, and light anesthesia. Methods/Design The DeLiT Trial is a factorial randomized single-center trial of dexamethasone vs placebo, intraoperative tight vs. conventional glucose control, and light vs deep anesthesia in patients undergoing major non-cardiac surgery. Anesthetic depth will be estimated with Bispectral Index (BIS) monitoring (Aspect medical, Newton, MA). The primary outcome is a composite of major postoperative morbidity including myocardial infarction, stroke, sepsis, and 30-day mortality. C-reactive protein, a measure of the inflammatory response, will be evaluated as a secondary outcome. One-year all-cause mortality as well as post-operative delirium will be additional secondary outcomes. We will enroll up to 970 patients which will provide 90% power to detect a 40% reduction in the primary outcome, including interim analyses for efficacy and futility at 25%, 50% and 75% enrollment. Discussion The DeLiT trial started in February 2007. We expect to reach our second interim analysis point in 2010. This large randomized controlled trial will provide a reliable assessment of the effects of corticosteroids, glucose control, and depth-of-anesthesia on perioperative inflammation and morbidity from major non-cardiac surgery. The factorial design will enable us to simultaneously study the effects of the three interventions in the same population, both individually and in different combinations. Such a design is an economically efficient way to study the three interventions in one clinical trial vs three. Trial registration This trial is registered at Clinicaltrials

  17. Cognitive rehabilitation for early post-surgery inpatients affected by primary brain tumor: a randomized, controlled trial.

    PubMed

    Zucchella, Chiara; Capone, Annarita; Codella, Valentina; De Nunzio, Alessandro Marco; Vecchione, Carmine; Sandrini, Giorgio; Pace, Andrea; Pierelli, Francesco; Bartolo, Michelangelo

    2013-08-01

    Cognitive impairment is one of the most common neurological disorders in neuro-oncological patients and exerts a deep negative impact on quality of life interfering with familiar, social and career-related activities. To test the effectiveness of early cognitive rehabilitation treatment for inpatients affected by primary brain tumors. Out of 109 consecutive patients enrolled in the study, 58 patients were randomly assigned to a rehabilitation group or to a control group. The rehabilitation consisted of 16 one-hour individual sessions of therapist-guided cognitive training, spread over 4 weeks, combining computer exercises and metacognitive training. Patients in the control group received usual care without cognitive training. All patients were evaluated by means of a comprehensive neuropsychological battery at the admission (T0) and after 4 weeks (T1). Patients in the rehabilitation group showed a significant improvement of cognitive functions. In particular, the domains that benefited most from the training were visual attention and verbal memory. The control group exhibited only a slightly, not statistically relevant, enhancement of cognitive performances. Cognitive rehabilitation for neuro-oncological inpatients resulted in a significant enhancement of cognitive performances after the training, also providing a foundation for early administration. Future research should be aimed to clarify the patients' characteristics that predict neuropsychological improvement, to identify the most effective elements in rehabilitative programs and to study the effects of treatment extension to everyday life. PMID:23677749

  18. Evaluating the Potential Effect of Melatonin on the post-Cardiac Surgery Sleep Disorder

    PubMed Central

    Dianatkhah, Mehrnoush; Ghaeli, Padideh; Hajhossein Talasaz, Azita; Karimi, Abbasali; Salehiomran, Abbas; Bina, Peyvand; Jalali, Arash; Ghaffary, Saba; Shahmansouri, Nazila; Vejdani, Shaghayegh

    2015-01-01

    Background: Postoperative neurological injuries, including cognitive dysfunction, sleep disorder, delirium, and anxiety, are the important consequences of coronary artery bypass graft surgery (CABG). Evidence has shown that postoperative sleep disturbance is partly due to disturbed melatonin secretion in the perioperative period. The aim of this study was to evaluate the effect of melatonin on postoperative sleep disorder in patients undergoing CABG. Method: One hundred forty-five elective CABG patients participated in a randomized double-blind study during the preoperative period. The patients were randomized to receive either 3 mg of melatonin or 10 mg of Oxazepam one hour before sleep time. Each group received the medication from 3 days before surgery until the time of discharge. Sleep quality was evaluated using the Groningen Sleep Quality Score (GSQS), and the incidence of delirium was evaluated by nursing records. Sleep quality and anxiety scores were compared before and after surgery through the Wilcoxon signed-rank test. The analysis of covariance (ANCOVA) and independent t-test were used to compare the sleep and anxiety scores between the groups. P values ≤ 0.05 were considered statistically significant. Results: Totally, 137 patients at a mean age of 60 years completed the study (76% male). The analysis of the data showed that sleep was significantly disturbed after surgery in both groups. The patients in the Oxazepam group demonstrated significantly higher disturbance in their mean postoperative GSQS score than did their counterparts in the melatonin group (p value < 0.001). A smaller proportion of the participants experienced delirium in the melatonin group (0.06%) than in the Oxazepam group (0.12%); however, this difference was not statistically significant. Conclusion: The result of the present study revealed that melatonin improved sleep in post-cardiac surgery patients more than what was observed with Oxazepam. Therefore, melatonin may be

  19. A Randomized Clinical Trial of the Health Evaluation and Referral Assistant (HERA): Research Methods

    PubMed Central

    Boudreaux, Edwin D.; Abar, Beau; Baumann, Brigitte M.; Grissom, Grant

    2013-01-01

    The Health Evaluation and Referral Assistant (HERA) is a web-based program designed to facilitate screening, brief intervention, and referral to treatment (SBIRT) for tobacco, alcohol, and drug abuse. After the patient completes a computerized substance abuse assessment, the HERA produces a summary report with evidence-based recommended clinical actions for the healthcare provider (the Healthcare Provider Report) and a report for the patient (the Patient Feedback Report) that provides education regarding the consequences of use, personally tailored motivational messages, and a tailored substance abuse treatment referral list. For those who provide authorization, the HERA faxes the individual’s contact information to a substance abuse treatment provider matched to the individual’s substance use severity and personal characteristics, like insurance and location of residence (dynamic referral). This paper summarizes the methods used for a randomized controlled trial to evaluate the HERA’s efficacy in leading to increased treatment initiation and reduced substance use. The study was performed in four emergency departments. Individual patients were randomized into one of two conditions: the HERA or assessment only. A total of 4,269 patients were screened and 1,006 participants enrolled. The sample was comprised of 427 tobacco users, 212 risky alcohol users, and 367 illicit drug users. Fourty-two percent used more than one substance class. The enrolled sample was similar to the eligible patient population. The study should enhance understanding of whether computer-facilitated SBIRT can impact process of care variables, such as promoting substance abuse treatment initiation, as well as its effect on subsequent substance abuse and related outcomes. PMID:23665335

  20. Involving parents from the start: formative evaluation for a large randomised controlled trial with Botswana Junior Secondary School students.

    PubMed

    Vig, Jessica; Miller, Kim S; Chirwa-Motswere, Catherine; Winskell, Kate; Stallcup, Elizabeth

    2016-03-01

    While HIV prevention research conducted among adolescent populations may encounter parental resistance, the active engagement of parents from inception to trial completion may alleviate opposition. In preparation for implementing a large randomised controlled trial (RCT) examining the efficacy of a behavioural intervention targeting adolescent sexual risk behaviours, a formative evaluation was undertaken to assess parental reactions to the proposed trial. Six focus groups were conducted with parents of adolescents (aged 13-17) from rural, peri-urban and urban junior secondary schools in Botswana. Focus groups explored comprehension and acceptability among parents of the forthcoming trial including HSV-2 testing, the return of results to the adolescent (not the parent), trial information materials and the parental consent process. Parents welcomed the study and understood and accepted its moral and ethical considerations. Their reactions regarding return of HSV-2 results only to adolescents (not the parent) were mixed. Parents understood the consent process and most agreed to consent, while indicating their desire to remain informed and involved throughout the RCT. The focus group discussions (FGDs) provided valuable information and insights that helped strengthen the study. As a result of parents' feedback, counselling procedures were strengthened and direct linkages to local services and care were made. Informational materials were revised to increase clarity, and materials and procedures were developed to encourage and support parental involvement and parent-child dialogue. Ultimately, parental feedback led to a decision by the Government of Botswana to allow parents to access their child's HSV-2 test results. PMID:27002354

  1. A Randomized Clinical Trial Evaluating rh-FGF-2/β-TCP in Periodontal Defects.

    PubMed

    Cochran, D L; Oh, T-J; Mills, M P; Clem, D S; McClain, P K; Schallhorn, R A; McGuire, M K; Scheyer, E T; Giannobile, W V; Reddy, M S; Abou-Arraj, R V; Vassilopoulos, P J; Genco, R J; Geurs, N C; Takemura, A

    2016-05-01

    Biological mediators have been used to enhance periodontal regeneration. The aim of this prospective randomized controlled study was to evaluate the safety and effectiveness of 3 doses of fibroblast growth factor 2 (FGF-2) when combined with a β-tricalcium phosphate (β-TCP) scaffold carrier placed in vertical infrabony periodontal defects in adult patients. In this double-blinded, dose-verification, externally monitored clinical study, 88 patients who required surgical intervention to treat a qualifying infrabony periodontal defect were randomized to 1 of 4 treatment groups-β-TCP alone (control) and 0.1% recombinant human FGF-2 (rh-FGF-2), 0.3% rh-FGF-2, and 0.4% rh-FGF-2 with β-TCP-following scaling and root planing of the tooth prior to a surgical appointment. Flap surgery was performed with EDTA conditioning of the root prior to device implantation. There were no statistically significant differences in patient demographics and baseline characteristics among the 4 treatment groups. When a composite outcome of gain in clinical attachment of 1.5 mm was used with a linear bone growth of 2.5 mm, a dose response pattern detected a plateau in the 0.3% and 0.4% rh-FGF-2/β-TCP groups with significant improvements over control and 0.1% rh-FGF-2/β-TCP groups. The success rate at 6 mo was 71% in the 2 higher-concentration groups, as compared with 45% in the control and lowest treatment groups. Percentage bone fill in the 2 higher-concentration groups was 75% and 71%, compared with 63% and 61% in the control and lowest treatment group. No increases in specific antibody to rh-FGF-2 were detected, and no serious adverse events related to the products were reported. The results from this multicenter trial demonstrated that the treatment of infrabony vertical periodontal defects can be enhanced with the addition of rh-FGF-2/β-TCP (ClinicalTrials.govNCT01728844). PMID:26908630

  2. Preoperative opioid strength may not affect outcomes of anterior cervical procedures: a post hoc analysis of 2 prospective, randomized trials

    PubMed Central

    Kelly, Michael P.; Anderson, Paul A.; Sasso, Rick C.; Riew, K. Daniel

    2015-01-01

    Object The aim of this study is to evaluate the relationship between preoperative opioid strength and outcomes of anterior cervical decompressive surgery. Methods A retrospective cohort of 1004 patients enrolled in 1 of 2 investigational device exemption studies comparing cervical total disc arthroplasty (TDA) and anterior cervical discectomy and fusion (ACDF) for single-level cervical disease causing radiculopathy or myelopathy was selected. At a preoperative visit, opioid use data, Neck Disability Index (NDI) scores, 36-ltem Short-Form Health Survey (SF-36) scores, and numeric rating scale scores for neck and arm pain were collected. Patients were divided into strong (oxycodone/morphine/meperidine), weak (codeine/propoxyphene/ hydrocodone), and opioid-naïve groups. Preoperative and postoperative (24 months) outcomes scores were compared within and between groups using the paired t-test and ANCOVA, respectively. Results Patients were categorized as follows: 226 strong, 762 weak, and 16 opioid naïve. The strong and weak groups were similar with respect to age, sex, race, marital status, education level, Worker's Compensation status, litigation status, and alcohol use. At 24-month follow-up, no differences in change in arm or neck pain scores (arm: strong –52.3, weak –50.6, naïve –54.0, p = 0.244; neck: strong –52.7, weak –50.8, naïve –44.6, p = 0.355); NDI scores (strong –36.0, weak –33.3, naïve –32.3, p = 0.181); or SF-36 Physical Component Summary scores (strong: 14.1, weak 13.3, naïve 21.7, p = 0.317) were present. Using a 15-point improvement in NDI to determine success, the authors found no between-groups difference in success rates (strong 80.6%, weak 82.7%, naïve 73.3%, p = 0.134). No difference existed between treatment arms (TDA vs ACDF) for any outcome at any time point. Conclusions Preoperative opioid strength did not adversely affect outcomes in this analysis. Careful patient selection can yield good results in this patient

  3. Enrollment in YFV Vaccine Trial: An Evaluation of Recruitment Outcomes Associated with a Randomized Controlled Double-Blind Trial of a Live Attenuated Yellow Fever Vaccine.

    PubMed

    Frew, Paula M; Shapiro, Eve T; Lu, Lu; Edupuganti, Srilatha; Keyserling, Harry L; Mulligan, Mark J

    2013-04-15

    This investigation evaluated several factors associated with diverse participant enrollment of a clinical trial assessing safety, immunogenicity, and comparative viremia associated with administration of 17-D live, attenuated yellow fever vaccine given alone or in combination with human immune globulin. We obtained baseline participant information (e.g., sociodemographic, medical) and followed recruitment outcomes from 2005 to 2007. Of 355 potential Yellow Fever vaccine study participants, 231 cases were analyzed. Strong interest in study participation was observed among racial and ethnically diverse persons with 36.34% eligible following initial study screening, resulting in 18.75% enrollment. The percentage of white participants increased from 63.66% (prescreened sample) to 81.25% (enrollment group). The regression model was significant with white race as a predictor of enrollment (OR=2.744, 95% CI=1.415-5.320, p=0.003).In addition, persons were more likely to enroll via direct outreach and referral mechanisms compared to mass advertising (OR=2.433, 95% CI=1.102-5.369). The findings indicate that racially diverse populations can be recruited to vaccine clinical trials, yet actual enrollment may not reflect that diversity. PMID:25221781

  4. Prevention of depression and anxiety in later life: design of a randomized controlled trial for the clinical and economic evaluation of a life-review intervention

    PubMed Central

    Korte, Jojanneke; Bohlmeijer, Ernst T; Smit, Filip

    2009-01-01

    Background Depressive and anxiety symptoms in older adults could develop into significant health problems with detrimental effects on quality of life and a possibly poor prognosis. Therefore, there is a need for preventive interventions which are at once effective, acceptable and economic affordable. Methods and design This paper describes the design of a study evaluating "The stories we live by", a preventive life-review group intervention, which was recently developed for adults of 55 years and over with depressive and anxiety symptoms. Both clinical and economic effectiveness will be evaluated in a pragmatic randomized controlled trial. The participants in the intervention condition will receive the 8-session preventive intervention. The participants in the control condition will have access to usual care. Clinical end-terms are depressive and anxiety symptoms, current major depressive episode, quality of life and positive mental health post-treatment (3 months after baseline) and at follow-ups (6 and 12 months after baseline). Additional goals of this study are to identify groups for whom the intervention is particularly effective and to identify the therapeutic pathways that are vital in inducing clinical change. This will be done by analyzing if treatment response is moderated by demographics, personality, past major depressive episodes, important life events and chronically disease, and mediated by reminiscence functions, perceived control, automatic positive thoughts and meaning in life. Finally the cost-effectiveness of the intervention relative to care as usual will be assessed by computing incremental costs per case of depression and anxiety avoided (cost-effectiveness) and per quality adjusted life year (QALY) (cost utility). Discussion It is expected that both the life-review intervention and its evaluation will contribute to the existing body of knowledge in several ways. First, the intervention is unique in linking life-review with narrative therapy

  5. A Phase I, Open-Label Trial, Evaluating the Safety and Immunogenicity of Candidate Tuberculosis Vaccines AERAS-402 and MVA85A, Administered by Prime-Boost Regime in BCG-Vaccinated Healthy Adults

    PubMed Central

    Satti, Iman; Hokey, David A.; Dheenadhayalan, Veerabadran; Stockdale, Lisa; Manjaly Thomas, Zita-Rose; Minhinnick, Alice; Wilkie, Morven; Vermaak, Samantha; Meyer, Joel; O’Shea, Matthew K.; Pau, Maria Grazia; Versteege, Isabella; Douoguih, Macaya; Hendriks, Jenny; Sadoff, Jerald; Landry, Bernard; Moss, Paul; McShane, Helen

    2015-01-01

    Background MVA85A and AERAS-402 are two clinically advanced viral vectored TB vaccine candidates expressing Mycobacterium tuberculosis antigens designed to boost BCG-induced immunity. Clinical trials with candidate malaria vaccines have demonstrated that adenoviral vector based priming immunisation, followed by MVA vector boost, induced high levels of immunity. We present the safety and immunogenicity results of the first clinical trial to evaluate this immunisation strategy in TB. Methods In this phase 1, open-label trial, 40 healthy previously BCG-vaccinated participants were enrolled into three treatment groups and vaccinated with 1 or 2 doses of AERAS-402 followed by MVA85A; or 3 doses of AERAS-402. Results Most related adverse events (AEs) were mild and there were no vaccine related serious AEs. Boosting AERAS-402 with MVA85A significantly increased Ag85A-specific T-cell responses from day of vaccination. Two priming doses of AERAS-402 followed by MVA85A boost, resulted in a significantly higher AUC post-peak Ag85A response compared to three doses of AERAS-402 and historical data with MVA85A vaccination alone. The frequency of CD8+ T-cells producing IFN-γ, TNF-α and IL-2 was highest in the group receiving two priming doses of AERAS-402 followed by MVA85A. Conclusions Vaccination with AERAS-402 followed by MVA85A was safe and increased the durability of antigen specific T-cell responses and the frequency and polyfunctionality of CD8+ T-cells, which may be important in protection against TB. Further clinical trials with adenoviral prime-MVA85A boost regimens are merited to optimise vaccination intervals, dose and route of immunisation and to evaluate this strategy in the target population in TB high burden countries. Trial Registration ClinicalTrials.gov NCT01683773. PMID:26529238

  6. An evaluation of prophylactic treatments to prevent post traumatic joint stiffness.

    PubMed

    Efird, Will; Kellam, Patrick; Yeazell, Shawn; Weinhold, Paul; Dahners, Laurence E

    2014-11-01

    Arthrofibrosis is a major obstacle to restoring joint function after trauma. The objective of this study was to evaluate montelukast, forskolin, and triamcinolone as possible means of prophylaxis against the formation of arthrofibrosis. Forty-eight rats underwent surgical knee trauma with post-operative immobilization in full flexion. The treatment groups were: control (CTL), oral montelukast (3.75 mg/kg/day) (MLK), intra-articular forskolin injections (0.6 mg/kg) (FSK), and intra-articular triamcinolone injections (0.68 mg/kg) (STR). Rats were sacrificed after 14 days and femorotibial contracture angles were measured with the posterior capsule intact and with the posterior capsule cut. A 0.015Nm extension moment was applied to the knee. All treatment groups had significant reductions in contracture angle compared to the control. Mean contractures with the posterior capsule intact were 32°(CTL), 20° (MLK), 22° (FSK), and 7° (STR). Contractures with the posterior capsule cut were 28° (CTL), 19° (MLK), 20° (FSK), and 5° (STR). The STR group was significantly better than FSK and MLK. Triamcinolone injections provided dramatic reductions in stiffness. Both forskolin and montelukast provided significant, though lesser, reductions in stiffness. While the triamcinolone contracture angles were significantly better, the novel treatments of forskolin and montelukast provided encouraging results and should be studied further. PMID:25073544

  7. Preliminary evaluation of PTSD Coach, a smartphone app for post-traumatic stress symptoms.

    PubMed

    Kuhn, Eric; Greene, Carolyn; Hoffman, Julia; Nguyen, Tam; Wald, Laura; Schmidt, Janet; Ramsey, Kelly M; Ruzek, Josef

    2014-01-01

    PTSD Coach is a mobile application (app) designed to help individuals who have post-traumatic stress disorder (PTSD) symptoms better understand and self-manage their symptoms. It has wide-scale use (over 130,000 downloads in 78 countries) and very favorable reviews but has yet to be evaluated. Therefore, this study examines user satisfaction, perceived helpfulness, and usage patterns of PTSD Coach in a sample of 45 veterans receiving PTSD treatment. After using PTSD Coach for several days, participants completed a survey of satisfaction and perceived helpfulness and focus groups exploring app use and benefit from use. Data indicate that participants were very satisfied with PTSD Coach and perceived it as being moderately to very helpful with their PTSD symptoms. Analysis of focus group data resulted in several categories of app use: to manage acute distress and PTSD symptoms, at scheduled times, and to help with sleep. These findings offer preliminary support for the acceptability and perceived helpfulness of PTSD Coach and suggest that it has potential to be an effective self-management tool for PTSD. Although promising, future research is required to validate this, given study limitations. PMID:24402979

  8. Evaluation of a Post-Processing Approach for Multiscale Analysis of Biphasic Mechanics of Chondrocytes

    PubMed Central

    Sibole, Scott C.; Maas, Steve; Halloran, Jason P.; Weiss, Jeffrey A.; Erdemir, Ahmet

    2014-01-01

    Understanding the mechanical behavior of chondrocytes as a result of cartilage tissue mechanics has significant implications for both evaluation of mechanobiological function and to elaborate on damage mechanisms. A common procedure for prediction of chondrocyte mechanics (and of cell mechanics in general) relies on a computational post-processing approach where tissue level deformations drive cell level models. Potential loss of information in this numerical coupling approach may cause erroneous cellular scale results, particularly during multiphysics analysis of cartilage. The goal of this study was to evaluate the capacity of 1st and 2nd order data passing to predict chondrocyte mechanics by analyzing cartilage deformations obtained for varying complexity of loading scenarios. A tissue scale model with a sub-region incorporating representation of chondron size and distribution served as control. The postprocessing approach first required solution of a homogeneous tissue level model, results of which were used to drive a separate cell level model (same characteristics as the subregion of control model). The 1st data passing appeared to be adequate for simplified loading of the cartilage and for a subset of cell deformation metrics, e.g., change in aspect ratio. The 2nd order data passing scheme was more accurate, particularly when asymmetric permeability of the tissue boundaries were considered. Yet, the method exhibited limitations for predictions of instantaneous metrics related to the fluid phase, e.g., mass exchange rate. Nonetheless, employing higher-order data exchange schemes may be necessary to understand the biphasic mechanics of cells under lifelike tissue loading states for the whole time history of the simulation. PMID:23809004

  9. Exploring the Impact of Grading Rubrics on Academic Performance: Findings from a Quasi-Experimental, Pre-Post Evaluation

    ERIC Educational Resources Information Center

    Howell, Rebecca J.

    2011-01-01

    This purpose of this pre-post, quasi-experimental evaluation was to explore the impact of grading rubric use on student academic performance. Cross-sectional data were derived from 80 undergraduates enrolled in an elective course at a research university during spring and fall 2009. The control group (n = 41), who completed the course's Assignment…

  10. Evaluation of Beef Cattle Operations Utilizing Different Seasons of Calving, Weaning Strategies, Post-weaning Management, and Retained Ownership

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Production data from a 3-yr study conducted at Fort Keogh Livestock and Range Research Laboratory near Miles City, MT were utilized to evaluate impacts of season of calving, weaning strategy, post-weaning management of replacement heifers, and retained ownership of steer calves on enterprise profita...

  11. PACE-UP (Pedometer and consultation evaluation - UP) – a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45–75 years: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Most adults do not achieve the 150 minutes weekly of at least moderate intensity activity recommended for health. Adults’ most common physical activity (PA) is walking, light intensity if strolling, moderate if brisker. Pedometers can increase walking; however, most trials have been short-term, have combined pedometer and support effects, and have not reported PA intensity. This trial will investigate whether pedometers, with or without nurse support, can help less active 45–75 year olds to increase their PA over 12 months. Methods/design Design: Primary care-based 3-arm randomized controlled trial with 12-month follow-up and health economic and qualitative evaluations. Participants: Less active 45–75 year olds (n = 993) will be recruited by post from six South West London general practices, maximum of two per household and households randomised into three groups. Step-count and time spent at different PA intensities will be assessed for 7 days at baseline, 3 and 12 months by accelerometer. Questionnaires and anthropometric assessments will be completed. Intervention: The pedometer-alone group will be posted a pedometer (Yamax Digi-Walker SW-200), handbook and diary detailing a 12-week pedometer-based walking programme, using targets from their baseline assessment. The pedometer-plus-support group will additionally receive three practice nurse PA consultations. The handbook, diary and consultations include behaviour change techniques (e.g., self-monitoring, goal-setting, relapse prevention planning). The control group will receive usual care. Outcomes: Changes in average daily step-count (primary outcome), time spent sedentary and in at least moderate intensity PA weekly at 12 months, measured by accelerometry. Other outcomes include change in body mass index, body fat, self-reported PA, quality of life, mood and adverse events. Cost-effectiveness will be assessed by the incremental cost of the intervention to the National Health Service

  12. 78 FR 36571 - Extension of Post-Sale Evaluation Period for Central Gulf of Mexico Planning Area Lease Sale 227

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ...This notice extends through July 18, 2013, the post-sale evaluation period for Central Gulf of Mexico Planning Area Lease Sale 227. BOEM will complete the evaluation process for all bids received in this sale by July 18, 2013. This action is necessary due to resource limitations resulting from sequestration. BOEM is unable to pay overtime to expedite the bid review process, including the......

  13. The role of nonrandomized trials in the evaluation of oncology drugs.

    PubMed

    Simon, R; Blumenthal, G M; Rothenberg, M L; Sommer, J; Roberts, S A; Armstrong, D K; LaVange, L M; Pazdur, R

    2015-05-01

    Although randomized trials provide the most reliable evidence of a drug's safety and efficacy, there are situations where randomized trials are not possible or ethical. In this article we discuss when and how single-arm trials can be used to support full approval of oncology drugs. These include situations in which an unprecedented effect on tumor response is observed in a setting of high unmet medical need, clinical trial patients have been well characterized, enabling a target population to be clearly defined, experience exists in a sufficient number of patients to allow adequate assessment of the risk:benefit relationship, and a proper historical context can be provided for analysis. We also discuss how response rates might be considered predictive of long-term outcomes or clinically meaningful in and of themselves in certain contexts. PMID:25676488

  14. Evaluation of a Musculoskeletal Model with Prosthetic Knee through Six Experimental Gait Trials

    PubMed Central

    Kia, Mohammad; Stylianou, Antonis P.; Guess, Trent M.

    2015-01-01

    Knowledge of the forces acting on musculoskeletal joint tissues during movement benefits tissue engineering, artificial joint replacement, and our understanding of ligament and cartilage injury. Computational models can be used to predict these internal forces, but musculoskeletal models that simultaneously calculate muscle force and the resulting loading on joint structures are rare. This study used publicly available gait, skeletal geometry, and instrumented prosthetic knee loading data [1] to evaluate muscle driven forward dynamics simulations of walking. Inputs to the simulation were measured kinematics and outputs included muscle, ground reaction, ligament, and joint contact forces. A full body musculoskeletal model with subject specific lower extremity geometries was developed in the multibody framework. A compliant contact was defined between the prosthetic femoral component and tibia insert geometries. Ligament structures were modeled with a nonlinear force-strain relationship. The model included 45 muscles on the right lower leg. During forward dynamics simulations a feedback control scheme calculated muscle forces using the error signal between the current muscle lengths and the lengths recorded during inverse kinematics simulations. Predicted tibiofemoral contact force, ground reaction forces, and muscle forces were compared to experimental measurements for six different gait trials using three different gait types (normal, trunk sway, and medial thrust). The mean average deviation (MAD) and root mean square deviation (RMSD) over one gait cycle are reported. The muscle driven forward dynamics simulations were computationally efficient and consistently reproduced the inverse kinematics motion. The forward simulations also predicted total knee contact forces (166 N < MAD < 404 N, 212 N < RMSD < 448 N) and vertical ground reaction forces (66 N < MAD < 90 N, 97 N < RMSD < 128 N) well within 28% and 16% of experimental loads respectively. However the

  15. Evaluation of a musculoskeletal model with prosthetic knee through six experimental gait trials.

    PubMed

    Kia, Mohammad; Stylianou, Antonis P; Guess, Trent M

    2014-03-01

    Knowledge of the forces acting on musculoskeletal joint tissues during movement benefits tissue engineering, artificial joint replacement, and our understanding of ligament and cartilage injury. Computational models can be used to predict these internal forces, but musculoskeletal models that simultaneously calculate muscle force and the resulting loading on joint structures are rare. This study used publicly available gait, skeletal geometry, and instrumented prosthetic knee loading data [1] to evaluate muscle driven forward dynamics simulations of walking. Inputs to the simulation were measured kinematics and outputs included muscle, ground reaction, ligament, and joint contact forces. A full body musculoskeletal model with subject specific lower extremity geometries was developed in the multibody framework. A compliant contact was defined between the prosthetic femoral component and tibia insert geometries. Ligament structures were modeled with a nonlinear force-strain relationship. The model included 45 muscles on the right lower leg. During forward dynamics simulations a feedback control scheme calculated muscle forces using the error signal between the current muscle lengths and the lengths recorded during inverse kinematics simulations. Predicted tibio-femoral contact force, ground reaction forces, and muscle forces were compared to experimental measurements for six different gait trials using three different gait types (normal, trunk sway, and medial thrust). The mean average deviation (MAD) and root mean square deviation (RMSD) over one gait cycle are reported. The muscle driven forward dynamics simulations were computationally efficient and consistently reproduced the inverse kinematics motion. The forward simulations also predicted total knee contact forces (166N

  16. Competence to stand trial evaluations of sovereign citizens: a case series and primer of odd political and legal beliefs.

    PubMed

    Parker, George F

    2014-01-01

    Sovereign citizens hold a variety of beliefs that challenge the legitimacy of the United States government and criminal justice system. In criminal cases, sovereign citizens typically raise a variety of seemingly strange objections to the proceedings that can cause court participants to believe the defendant is not competent to stand trial. The author's case files were reviewed to identify all defendants who espoused sovereign citizen beliefs during a court-ordered competence-to-stand-trial evaluation. This case series consisted of nine evaluations completed between 2003 and 2012. A review of the outcomes in these cases showed that sovereign citizens typically have the capacity to understand criminal proceedings and assist an attorney. PMID:25187287

  17. The challenge of conducting pharmacoeconomic evaluations in oncology using crossover trials: the example of sunitinib for gastrointestinal stromal tumour.

    PubMed

    Chabot, Isabelle; LeLorier, Jacques; Blackstein, Martin E

    2008-05-01

    This paper examines the challenge of conducting economic evaluations to support patient access to cancer therapies when the cost-effectiveness estimation is hampered by crossover trial design. To demonstrate these limitations, we present the submission to the Canadian Drug Review (CDR) of a cost-effectiveness evaluation of sunitinib versus best supportive care (BSC) for the treatment of gastrointestinal stromal tumour in patients intolerant or resistant to imatinib. The economic model generated an incremental cost-effectiveness ratio for sunitinib versus BSC of dollars 79,884/quality-adjusted life-year gained. Eight months after initial submission, CDR granted a final recommendation to fund sunitinib following the manufacturer's appeal against their first recommendation. Although cost-effectiveness is an important consideration in reimbursement decisions, there is a need for improved decision-making processes for cancer drugs, as well as a better understanding of the limitations of clinical trial design. PMID:18372169

  18. Defining, Designing, Implementing, and Evaluating Phase 4 HIV Prevention Effectiveness Trials for Vulnerable Populations

    PubMed Central

    Kelly, Jeffrey A.; Spielberg, Freya; McAuliffe, Timothy L.

    2008-01-01

    Summary The efficacy of behavioral HIV prevention interventions has been convincingly demonstrated in a large number of randomized controlled phase 3 research outcome trials. Little research attention has been directed toward studying the effectiveness of the same interventions when delivered by providers to their own clients or community members, however. This article argues for the need to conduct phase 4 effectiveness trials of HIV prevention interventions that have been found efficacious in the research arena. Such trials can provide important information concerning the impact of interventions when applied in heterogeneous “real-world” circumstances. This article raises design issues and methodologic questions that need to be addressed in the conduct of phase 4 trials of behavioral interventions. These issues include the selection and training of service providers engaged in such trials, maintenance of fidelity to intervention protocol in provider-delivered interventions, determination of intervention core elements versus aspects that require tailoring, selection of relevant phase 4 study outcomes, interpretation of findings indicative of field effectiveness, sustainability, and other aspects of phase 4 trial design. PMID:18301131

  19. The Method of the Evaluation of the Efficiency of the Processes Carried Out at Traffic Maintenance Subsystem Posts

    NASA Astrophysics Data System (ADS)

    Migawa, Klaudiusz

    2012-12-01

    In the systems of the exploitation of means of transport in order to assure correct carrying out of the assigned transport tasks, it is necessary to maintain the required number of vehicles in the state of task availability. It is obtained as a result of carrying out of service and repair processes at the traffic maintenance subsystem posts. From the point of view of the effectiveness of the operation of the systems of the exploitation of means of transport, the damaged technological objects should be serviced in the shortest possible time. In the case of the system of the exploitation of means of transport the task of the traffic maintenance subsystem is the servicing of the required number of damaged means of transport over the assigned time interval defined by the transport task timetable. One of the methods of the evaluation of the degree of carrying out of the processes at the traffic maintenance subsystem posts is defining the efficiency of the posts of the subsystem. This paper presents the method of defining the efficiency of traffic maintenance subsystem in the system of the exploitation of means of transport measured by the probability value of servicing of the required number of technological objects over the assigned time interval. The resulting characteristics were presented on a general basis as well as in the form of exponential distribution and Erlang distribution. Moreover, for the utilization data obtained in tests carried out in an actual means of transport system the values of the analyzed characteristics were defined. The evaluation of the efficiency of the traffic maintenance subsystem posts may serve as the basis of decision making as to the change of the number and type of the used service and repair posts in the tested system as well as modification of the carried out exploitation strategy. The suggested method may be used for individual post, a group of posts of a given type as well as for a subsystem of traffic maintenance analyzed as a

  20. The Devon Active Villages Evaluation (DAVE) trial of a community-level physical activity intervention in rural south-west England: a stepped wedge cluster randomised controlled trial

    PubMed Central

    2014-01-01

    Background The majority of adults are not meeting the guidelines for physical activity despite activity being linked with numerous improvements to long-term health. In light of this, researchers have called for more community-level interventions. The main objective of the present study was to evaluate whether a community-level physical activity intervention increased the activity levels of rural communities. Methods 128 rural villages (clusters) were randomised to receive the intervention in one of four time periods between April 2011 and December 2012. The Devon Active Villages intervention provided villages with 12 weeks of physical activity opportunities for all age groups, including at least three different types of activities per village. Each village received an individually tailored intervention, incorporating a local needs-led approach. Support was provided for a further 12 months following the intervention. The evaluation study used a stepped wedge cluster randomised controlled trial design. All 128 villages were measured at each of five data collection periods using a postal survey. The primary outcome of interest was the proportion of adults reporting sufficient physical activity to meet internationally recognised guidelines. Minutes spent in moderate-and-vigorous activity per week was analysed as a secondary outcome. To compare between intervention and control modes, random effects linear regression and marginal logistic regression models were implemented for continuous and binary outcomes respectively. Results 10,412 adults (4693 intervention, 5719 control) completed the postal survey (response rate 32.2%). The intervention did not increase the odds of adults meeting the physical activity guideline (adjusted OR 1.02, 95% CI: 0.88 to 1.17; P = 0.80), although there was weak evidence of an increase in minutes of moderate-and-vigorous-intensity activity per week (adjusted mean difference = 171, 95% CI: -16 to 358; P = 0.07). The

  1. Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity. The STILE trial.

    PubMed Central

    1994-01-01

    PURPOSE: This study was designed to evaluate intra-arterial thrombolytic therapy as part of a treatment strategy for patients requiring revascularization for lower limb ischemia caused by nonembolic arterial and graft occlusion. MATERIALS AND METHODS: Patients with native arterial or bypass graft occlusion were randomized prospectively to either optimal surgical procedure or intra-arterial, catheter-directed thrombolysis with recombinant tissue plasminogen activator (rt-PA) or urokinase (UK). Thrombolysis patients required successful catheter placement into the occlusion before infusion of either rt-PA at 0.05 mg/kg/hr for up to 12 hours or UK of 250,000 units bolus followed by 4000 units/min x 4 hours, then 2000 units/min for up to 36 hours. A composite clinical outcome of death, ongoing/recurrent ischemia, major amputation, and major morbidity was the primary endpoint. Additional endpoints were reduction in surgical procedure, clinical outcome classification, length of hospitalization, and outcome by duration of ischemia. RESULTS: Randomization was terminated at 393 patients because a significant primary endpoint occurred by the first interim analysis. Failure of catheter placement occurred in 28% of patients who were randomized to lysis, and thus, were considered treatment failures. Thirty-day outcomes demonstrated significant benefit to surgical therapy compared with thrombolysis (p < 0.001), primarily because of a reduction in ongoing/recurrent ischemia (p < 0.001). However, clinical outcome classification at 30 days was similar. Stratification by duration of ischemia indicated that patients with ischemic deterioration of 0 to 14 days had lower amputation rates with thrombolysis (p = 0.052) and shorter hospital stays (p < 0.04). Patients with ischemic deterioration of > 14 days who who were treated surgically had less ongoing/recurrent ischemia (p < 0.001) and trends toward lower morbidity (p = 0.1). At 6-month follow-up, there was improved amputation

  2. Study on the safety and efficacy of miltefosine for the treatment of children and adolescents with post-kala-azar dermal leishmaniasis in Bangladesh, and an association of serum vitamin E and exposure to arsenic with post-kala-azar dermal leishmaniasis: an open clinical trial and case–control study protocol

    PubMed Central

    Mondal, D; Hasnain, M G; Hossain, M S; Ghosh, D; Ghosh, P; Hossain, H; Baker, J; Nath, R; Haque, R; Matlashewski, G; Hamano, S

    2016-01-01

    Introduction Post-kala-azar dermal leishmaniasis (PKDL) is a dermatological complication that occurs primarily among treated visceral leishmaniasis (VL) patients, and sporadically in a few without a history of VL. It mostly affects children and adolescents but is also common in adults. The conventional treatment with 120 intramuscular injections of sodium stibogluconate (SSG) is phasing out. Miltefosine (MF) is the only eventual alternative to SSG; however, its efficacy and safety profiles for treatment of children and adolescents with PKDL are lacking. In addition, risk factors for PKDL are poorly investigated. Host genetic, nutritional and environmental factors could be potential risk factors. As such, here we propose to evaluate the efficacy and safety of MF for 12 weeks at an allometric dose for children and adolescents with PKDL, and also to explore potential risk factors for PKDL. Methods and analysis A cross-sectional survey will look for suspected participants with PKDL among treated VL children and adolescents, a subsequent open clinical trial with MF at allometric dose, with a follow-up at 12 months. A case–control study will be carried out for PKDL risk factors. Assuming 95% cure rate, 95% CI and α=0.05, a sample size of 73 children with PKDL is needed. Considering an attrition rate of 10%, the final sample size is 80 children in each group. Descriptive and analytical analyses will be performed. Primary outcome is safety and cure rate of 12 weeks of treatment with MF. Ethics and dissemination International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) Ethical Review Committee (ERC) approved the protocol (PR#013045). Written informed consent will be taken from all participants and their guardians (in case of minor). A Data and Safety Monitoring Board (DSMB) of ICDDR,B ERC will monitor all study activities to ensure the safety of the participants. Trial registration number NCT02193022; Pre-results. PMID:27188804

  3. Monotherapy with pixantrone in histologically confirmed relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: post-hoc analyses from a phase III trial.

    PubMed

    Pettengell, Ruth; Sebban, Catherine; Zinzani, Pier Luigi; Derigs, Hans Gunter; Kravchenko, Sergey; Singer, Jack W; Theocharous, Panteli; Wang, Lixia; Pavlyuk, Mariya; Makhloufi, Kahina M; Coiffier, Bertrand

    2016-09-01

    This post hoc analysis of a phase 3 trial explored the effect of pixantrone in patients (50 pixantrone, 47 comparator) with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) confirmed by centralized histological review. Patients received 28-d cycles of 85 mg/m(2) pixantrone dimaleate (equivalent to 50 mg/m(2) in the approved formulation) on days 1, 8 and 15, or comparator. The population was subdivided according to previous rituximab use and whether they received the study treatment as 3rd or 4th line. Median number of cycles was 4 (range, 2-6) with pixantrone and 3 (2-6) with comparator. In 3rd or 4th line, pixantrone was associated with higher complete response (CR) (23·1% vs. 5·1% comparator, P = 0·047) and overall response rate (ORR, 43·6% vs. 12·8%, P = 0·005). In 3rd or 4th line with previous rituximab (20 pixantrone, 18 comparator), pixantrone produced better ORR (45·0% vs. 11·1%, P = 0·033), CR (30·0% vs. 5·6%, P = 0·093) and progression-free survival (median 5·4 vs. 2·8 months, hazard ratio 0·52, 95% confidence interval 0·26-1·04) than the comparator. Similar results were found in patients without previous rituximab. There were no unexpected safety issues. Pixantrone monotherapy is more effective than comparator in relapsed or refractory aggressive B-cell NHL in the 3rd or 4th line setting, independently of previous rituximab. PMID:27118109

  4. Tolerability and Clinical Activity of Post-Transplantation Azacitidine in Patients Allografted for Acute Myeloid Leukemia Treated on the RICAZA Trial.

    PubMed

    Craddock, Charles; Jilani, Nadira; Siddique, Shamyla; Yap, Christina; Khan, Josephine; Nagra, Sandeep; Ward, Janice; Ferguson, Paul; Hazlewood, Peter; Buka, Richard; Vyas, Paresh; Goodyear, Oliver; Tholouli, Eleni; Crawley, Charles; Russell, Nigel; Byrne, Jenny; Malladi, Ram; Snowden, John; Dennis, Mike

    2016-02-01

    Disease relapse is the major causes of treatment failure after allogeneic stem cell transplantation (SCT) in patients with acute myeloid leukemia (AML). As well as demonstrating significant clinical activity in AML, azacitidine (AZA) upregulates putative tumor antigens, inducing a CD8(+) T cell response with the potential to augment a graft-versus-leukemia effect. We, therefore, studied the feasibility and clinical sequelae of the administration of AZA during the first year after transplantation in 51 patients with AML undergoing allogeneic SCT. Fourteen patients did not commence AZA either because of transplantation complications or withdrawal of consent. Thirty-seven patients commenced AZA at a median of 54 days (range, 40 to 194 days) after transplantation, which was well tolerated in the majority of patients. Thirty-one patients completed 3 or more cycles of AZA. Sixteen patients relapsed at a median time of 8 months after transplantation. No patient developed extensive chronic graft-versus-host disease. The induction of a post-transplantation CD8(+) T cell response to 1 or more tumor-specific peptides was studied in 28 patients. Induction of a CD8(+) T cell response was associated with a reduced risk of disease relapse (hazard ratio [HR], .30; 95% confidence interval [CI], .10 to .85; P = .02) and improved relapse-free survival (HR, .29; 95% CI, .10 to .83; P = .02) taking into account death as a competing risk. In conclusion, AZA is well tolerated after transplantation and appears to have the capacity to reduce the relapse risk in patients who demonstrate a CD8(+) T cell response to tumor antigens. These observations require confirmation in a prospective clinical trial. PMID:26363443

  5. Tolerability and Clinical Activity of Post-Transplantation Azacitidine in Patients Allografted for Acute Myeloid Leukemia Treated on the RICAZA Trial

    PubMed Central

    Craddock, Charles; Jilani, Nadira; Siddique, Shamyla; Yap, Christina; Khan, Josephine; Nagra, Sandeep; Ward, Janice; Ferguson, Paul; Hazlewood, Peter; Buka, Richard; Vyas, Paresh; Goodyear, Oliver; Tholouli, Eleni; Crawley, Charles; Russell, Nigel; Byrne, Jenny; Malladi, Ram; Snowden, John; Dennis, Mike

    2016-01-01

    Disease relapse is the major causes of treatment failure after allogeneic stem cell transplantation (SCT) in patients with acute myeloid leukemia (AML). As well as demonstrating significant clinical activity in AML, azacitidine (AZA) upregulates putative tumor antigens, inducing a CD8+ T cell response with the potential to augment a graft-versus-leukemia effect. We, therefore, studied the feasibility and clinical sequelae of the administration of AZA during the first year after transplantation in 51 patients with AML undergoing allogeneic SCT. Fourteen patients did not commence AZA either because of transplantation complications or withdrawal of consent. Thirty-seven patients commenced AZA at a median of 54 days (range, 40 to 194 days) after transplantation, which was well tolerated in the majority of patients. Thirty-one patients completed 3 or more cycles of AZA. Sixteen patients relapsed at a median time of 8 months after transplantation. No patient developed extensive chronic graft-versus-host disease. The induction of a post-transplantation CD8+ T cell response to 1 or more tumor-specific peptides was studied in 28 patients. Induction of a CD8+ T cell response was associated with a reduced risk of disease relapse (hazard ratio [HR], .30; 95% confidence interval [CI], .10 to .85; P = .02) and improved relapse-free survival (HR, .29; 95% CI, .10 to .83; P = .02) taking into account death as a competing risk. In conclusion, AZA is well tolerated after transplantation and appears to have the capacity to reduce the relapse risk in patients who demonstrate a CD8+ T cell response to tumor antigens. These observations require confirmation in a prospective clinical trial. PMID:26363443

  6. Microbial and dietary factors associated with the 8-prenylnaringenin producer phenotype: a dietary intervention trial with fifty healthy post-menopausal Caucasian women.

    PubMed

    Bolca, Selin; Possemiers, Sam; Maervoet, Veerle; Huybrechts, Inge; Heyerick, Arne; Vervarcke, Stefaan; Depypere, Herman; De Keukeleire, Denis; Bracke, Marc; De Henauw, Stefaan; Verstraete, Willy; Van de Wiele, Tom

    2007-11-01

    Hop-derived food supplements and beers contain the prenylflavonoids xanthohumol (X), isoxanthohumol (IX) and the very potent phyto-oestrogen (plant-derived oestrogen mimic) 8-prenylnaringenin (8-PN). The weakly oestrogenic IX can be bioactivated via O-demethylation to 8-PN. Since IX usually predominates over 8-PN, human subjects may be exposed to increased doses of 8-PN. A dietary intervention trial with fifty healthy post-menopausal Caucasian women was undertaken. After a 4 d washout period, participants delivered faeces, blank urine and breath samples. Next, they started a 5 d treatment with hop-based supplements that were administered three times per d and on the last day, a 24 h urine sample was collected. A semi-quantitative FFQ was used to estimate fat, fibre, alcohol, caffeine and theobromine intakes. The recoveries of IX, 8-PN and X in the urine were low and considerable inter-individual variations were observed. A five-fold increase in the dosage of IX without change in 8-PN concentration resulted in a significant lower IX recovery and a higher 8-PN recovery. Classification of the subjects into poor (60%), moderate (25%) and strong (15%) 8-PN producers based on either urinary excretion or microbial bioactivation capacity gave comparable results. Recent antibiotic therapy seemed to affect the 8-PN production negatively. A positive trend between methane excretion and 8-PN production was observed. Strong 8-PN producers consumed less alcohol and had a higher theobromine intake. From this study we conclude that in vivo O-demethylation of IX increases the oestrogenic potency of hop-derived products. PMID:17521469

  7. Cost effectiveness of patient education for the prevention of falls in hospital: economic evaluation from a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Falls are one of the most frequently occurring adverse events that impact upon the recovery of older hospital inpatients. Falls can threaten both immediate and longer-term health and independence. There is need to identify cost-effective means for preventing falls in hospitals. Hospital-based falls prevention interventions tested in randomized trials have not yet been subjected to economic evaluation. Methods Incremental cost-effectiveness analysis was undertaken from the health service provider perspective, over the period of hospitalization (time horizon) using the Australian Dollar (A$) at 2008 values. Analyses were based on data from a randomized trial among n = 1,206 acute and rehabilitation inpatients. Decision tree modeling with three-way sensitivity analyses were conducted using burden of disease estimates developed from trial data and previous research. The intervention was a multimedia patient education program provided with trained health professional follow-up shown to reduce falls among cognitively intact hospital patients. Results The short-term cost to a health service of one cognitively intact patient being a faller could be as high as A$14,591 (2008). The education program cost A$526 (2008) to prevent one cognitively intact patient becoming a faller and A$294 (2008) to prevent one fall based on primary trial data. These estimates were unstable due to high variability in the hospital costs accrued by individual patients involved in the trial. There was a 52% probability the complete program was both more effective and less costly (from the health service perspective) than providing usual care alone. Decision tree modeling sensitivity analyses identified that when provided in real life contexts, the program would be both more effective in preventing falls among cognitively intact inpatients and cost saving where the proportion of these patients who would otherwise fall under usual care conditions is at least 4.0%. Conclusions This economic

  8. Refractory depression: mechanisms and evaluation of radically open dialectical behaviour therapy (RO-DBT) [REFRAMED]: protocol for randomised trial

    PubMed Central

    Lynch, T R; Whalley, B; Hempel, R J; Byford, S; Clarke, P; Clarke, S; Kingdon, D; O'Mahen, H; Russell, I T; Shearer, J; Stanton, M; Swales, M; Watkins, A; Remington, B

    2015-01-01

    Introduction Only 30–40% of depressed patients treated with medication achieve full remission. Studies that change medication or augment it by psychotherapy achieve only limited benefits, in part because current treatments are not designed for chronic and complex patients. Previous trials have excluded high-risk patients and those with comorbid personality disorder. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a novel, transdiagnostic treatment for disorders of emotional over-control. The REFRAMED trial aims to evaluate the effectiveness and cost-effectiveness of RO-DBT for patients with treatment-resistant depression. Methods and analysis REFRAMED is a multicentre randomised controlled trial, comparing 7 months of individual and group RO-DBT treatment with treatment as usual (TAU). Our primary outcome measure is depressive symptoms 12 months after randomisation. We shall estimate the cost-effectiveness of RO-DBT by cost per quality-adjusted life year. Causal analyses will explore the mechanisms by which RO-DBT is effective. Ethics and dissemination The National Research Ethics Service (NRES) Committee South Central – Southampton A first granted ethical approval on 20 June 2011, reference number 11/SC/0146. Trial registration number ISRCTN85784627. PMID:26187121

  9. Reflections by contrarians on the post-CREST evaluation of carotid stenting for stroke prevention.

    PubMed

    Barnett, Henry J M; Pelz, David M; Lownie, Stephen P

    2010-12-01

    Carotid angioplasty and stenting has become a popular alternative to carotid endarterectomy for the treatment of carotid stenosis in stroke. Evidence from early randomized controlled trials comparing these interventions revealed mixed results. The largest such trial, the Carotid Revascularization Endarterectomy vs. Stenting Trial recently showed equivalence of the procedures in a mixed cohort of both symptomatic and asymptomatic patients. These results have been heralded in North America as definitively demonstrating the safety and efficacy of carotid angioplasty and stenting, making it an attractive alternative to carotid endarterectomy. It is therefore probable that many more asymptomatic patients will be subjected to Carotid angioplasty and stenting, perceived by many to be less invasive than carotid endarterectomy. The authors argue that the design of Carotid Revascularization Endarterectomy vs. Stenting Trial was flawed by the mixture of two dissimilar patient groups, thus violating the principle of ceteris paribus, essential for the validity of a randomized controlled trials. The evidence for any invasive treatment of asymptomatic carotid disease is weak, with recent data favouring purely medical management. The authors believe that carotid angioplasty and stenting in asymptomatic patients should cease until better evidence is available. PMID:21050401

  10. Rationale, design and methods for a randomised and controlled trial to evaluate "Animal Fun" - a program designed to enhance physical and mental health in young children

    PubMed Central

    2010-01-01

    Background Children with poor motor ability have been found to engage less in physical activities than other children, and a lack of physical activity has been linked to problems such as obesity, lowered bone mineral density and cardiovascular risk factors. Furthermore, if children are confident with their fine and gross motor skills, they are more likely to engage in physical activities such as sports, crafts, dancing and other physical activity programs outside of the school curriculum which are important activities for psychosocial development. The primary objective of this project is to comprehensively evaluate a whole of class physical activity program called Animal Fun designed for Pre-Primary children. This program was designed to improve the child's movement skills, both fine and gross, and their perceptions of their movement ability, promote appropriate social skills and improve social-emotional development. Methods The proposed randomized and controlled trial uses a multivariate nested cohort design to examine the physical (motor coordination) and psychosocial (self perceptions, anxiety, social competence) outcomes of the program. The Animal Fun program is a teacher delivered universal program incorporating animal actions to facilitate motor skill and social skill acquisition and practice. Pre-intervention scores on motor and psychosocial variables for six control schools and six intervention schools will be compared with post-intervention scores (end of Pre-Primary year) and scores taken 12 months later after the children's transition to primary school Year 1. 520 children aged 4.5 to 6 years will be recruited and it is anticipated that 360 children will be retained to the 1 year follow-up. There will be equal numbers of boys and girls. Discussion If this program is found to improve the child's motor and psychosocial skills, this will assist in the child's transition into the first year of school. As a result of these changes, it is anticipated that

  11. Exposure therapy changes dysfunctional evaluations of somatic symptoms in patients with hypochondriasis (health anxiety). A randomized controlled trial.

    PubMed

    Weck, Florian; Neng, Julia M B; Schwind, Julia; Höfling, Volkmar

    2015-08-01

    Dysfunctional evaluations of somatic symptoms are considered a central factor in maintaining hypochondriasis. The aim of the current study was to investigate whether exposure therapy (ET) without cognitive restructuring is sufficient to change dysfunctional evaluations of somatic symptoms. The current study was based on a randomized controlled trial and compared patients with hypochondriasis (N=73) receiving ET or cognitive therapy (CT) to a wait list (WL) control group. In both the ET and CT groups, dysfunctional symptom evaluations changed significantly compared with the WL group. No differences between the ET and CT groups emerged. The relationship between the treatment condition (active treatment vs. WL) and reductions in health anxiety was mediated by changes in somatic symptom evaluations only in a specific card sorting procedure. We conclude that addressing dysfunctional symptom evaluations is a necessary precondition for the effective treatment of hypochondriasis. However, the results indicate that ET and CT appear to change those processes to a similar degree. PMID:26093823

  12. Evaluation of light transmission through different esthetic posts and its influence on the degree of polymerization of a dual cure resin cement

    PubMed Central

    Taneja, Sonali; Kumari, Manju; Gupta, Anupama

    2013-01-01

    Aim: To measure the light transmission through different esthetic posts and to evaluate the degree of polymerization of dual cure resin cement cured through these posts. Materials and Methods: The posts were divided into two experimental groups i.e. Group A (D.T. Light post); Group B (D.T. White post) and control i.e. Group C (metal post), each group having 10 samples. Posts of each group were illuminated with curing light and photographs were taken keeping the parameters standardized to evaluate the intensity of light transmission at different levels. The degree of polymerization of dual cure resin cement was evaluated using Fourier Transform Infrared spectroscopy. The data obtained was subjected to statistical analysis. Results: D.T. Light post showed highest light transmission and degree of polymerization. The light intensity decreased from cervical to apical for both esthetic post but the decrease from middle to apical third was insignificant for D.T. White post group. No light transmission was detected in metal post but the degree of polymerization decreased significantly from cervical to middle third. Conclusion: Cementation of fibre post with superior light transmitting ability using dual cured resin cement resulted in increased degree of polymerization. PMID:23349573

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

    PubMed Central

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

    2012-01-01

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

  14. Estimating the Single-Trial Characteristics of Event-Related Responses: Evaluation of the MCERP Algorithm

    NASA Technical Reports Server (NTRS)

    Knuth, K. H.; Shah, A. S.; Truccolo, W. A.; Ding, M.; Bressler, S. L.; Schroeder, C. E.; Korsmey, Dave (Technical Monitor)

    2002-01-01

    Single-trial event-related responses collected during the course of an experiment are typically averaged before analysis resulting in a rather crude picture of event-related brain dynamics. It has been quite clear for some time that these responses exhibit trial-to-trial variability: however, the computational techniques necessary to deal with such responses in noisy conditions have not been available. To this end we have developed the multiple-component, event-related potential model (mcERP), which assumes that the each event-related response consists of a sum of multiple evoked components each described by a stereotypical waveshape. These waveshapes are allowed to vary in amplitude and onset latency from trial to trial, which allows us to capture, to first-order, the trial-dependent variations in event-related brain dynamics. We have constructed many sets of synthetic data designed to simulate intracortical recordings from a 15 channel, linear-array multielectrode implanted acutely in V1 of an awake-behaving macaque undergoing visual stimulation with a red light flash. This synthetic data was used to characterize the performance of the mcERP algorithm. First we quantified the degree to which such trial-to-trial variability aids in the identification of multiple components, and we demonstrate that amplitude variability is a more important factor in component separation than latency variability. Second, we quantified the behavior of the algorithm under two distinct signal-to-noise ratio (SNR) conditions: Gaussian noise independently present in each channel, and highly correlated (1/f distributed), far-field noise presented identically in each channel of the array. The mcERP algorithm was found to be robust to noise accurately identifying all component waveshapes and their associated single-trial characteristics down to SNR levels of -20dB for Gaussian noise and -7dB for 1/f far-field noise. Comparisons of the performance of this algorithm with factor analysis (FA

  15. Evaluation of CMIP5 Models for post-1950 Weakening of Indian Monsoon

    NASA Astrophysics Data System (ADS)

    Saha, Anamitra; Saheer, Sahana; Ghosh, Subimal; Rao Emmela, Panakala

    2015-04-01

    Indian summer monsoon rainfall (ISMR) impacts the life of more than one billion people; the mean seasonal (from June to September) rainfall contributes to 80% of total annual rainfall in India; and the intraseasonal to interannual variability controls the agricultural productivity and the gross domestic product (GDP) of the country. ISMR has been found to have a decreasing trend in the recent decades (post-1950), which poses a major threat to water and food security of India. In order to adapt to such changes, reliable projection of ISMR by General Circulation Models (GCM) is required. But majority of new generation climate models from Coupled Model Inter-comparison Project phase5 (CMIP5) fail to simulate the observed decreasing trend of ISMR; most of the models show either no trend or increasing trend. The reason behind such failure is investigated and it has been found that large scale geophysical processes, which are responsible for weakening of Indian monsoon, are not very well simulated by the climate models. The decreasing trend of ISMR is associated with the warming of Southern Indian Ocean (SIO) and anomalous cyclonic formation in the western tropical Pacific Ocean. Increase in sea surface temperature (SST) and expansion of warm pool in SIO in recent decades has decreased the meridional SST gradient and weakened the monsoon south-westerly winds. On the other hand, increasing SST and strengthening anomalous cyclonic formation in Pacific Ocean has set a favourable condition for increasing local precipitation, which brings cold and dry wind from continental subtropics to south Asian monsoon region by teleconnection. Both of these large scale changes are not properly captured by CMIP5 models, with few exceptions, which is responsible for their failure. Proper representation of these highlighted geophysical processes in next generation models, may improve the reliability of ISMR projections. Findings of this study alert the water resource planners to evaluate

  16. Project Towards No Tobacco Use: implementation, process and post-test knowledge evaluation.

    PubMed

    Sussman, S; Dent, C W; Stacy, A W; Hodgson, C S; Burton, D; Flay, B R

    1993-03-01

    This paper describes the curricula contents, and presents data to evaluate the implementation, process and immediate post-test knowledge of Project Towards No Tobacco Use (Project TNT). Four different school-based tobacco use prevention curricula were developed to counteract the effects of three types of tobacco use acquisition variables typically addressed within a comprehensive social influences program: (1) peer approval for using tobacco (normative social influence), (2) incorrect social informational provided about tobacco use (information social influence) and (3) lack of knowledge or misperceptions about physical consequences resulting from tobacco use. Three curricula were designed to counteract the effects of single acquisition variables, whereas a fourth curriculum was designed to counteract the effects of combined social and physical consequences-related influences. These curricula were delivered to seventh grade students by trained project health educators to maximize implementation. 'Program' schools, those schools that received one of these curricula, were compared to 'control' schools that provided asystematic health education delivered by school personnel. A total of five conditions were contrasted through use of a randomized experiment involving 48 southern California junior high schools. This paper documents high levels of implementation in all program conditions. Also, favorable process ratings were obtained across the four program conditions, using multiple measures and sources of ratings (students, health educators and classroom teachers who observed curricula delivery). Finally, knowledge item sets completed by the students demonstrated discriminant validity across all five conditions. Because the program conditions were discriminable, yet were quite similar in implementation and process ratings, planned future study of behavioral outcomes can be interpreted as relatively uncontaminated by delivery or credibility confounds. PMID:11067179

  17. Post-Acute Coronary Syndrome Alcohol Abuse: Prospective Evaluation in the ERICO Study

    PubMed Central

    Morilha, Abner; Karagulian, Samuel; Lotufo, Paulo A.; Santos, Itamar S.; Benseñor, Isabela M.; Goulart, Alessandra C.

    2015-01-01

    Background Some studies have indicated alcohol abuse as one of the contributors to the development of cardiovascular disease, particularly coronary heart disease. However, this relationship is controversial. Objective To investigate the relationship between post-acute coronary syndrome (ACS) alcohol abuse in the Acute Coronary Syndrome Registry Strategy (ERICO Study). Methods 146 participants from the ERICO Study answered structured questionnaires and underwent laboratory evaluations at baseline, 30 days and 180 days after ACS. The Alcohol Use Disorders Identification Test (AUDIT) was applied to assess harmful alcohol consumption in the 12 months preceding ACS (30 day-interview) and six months after that. Results The frequencies of alcohol abuse were 24.7% and 21.1% in the 12 months preceding ACS and six months after that, respectively. The most significant cardiovascular risk factors associated with high-risk for alcohol abuse 30 days after the acute event were: male sex (88.9%), current smoking (52.8%) and hypertension (58.3%). Six months after the acute event, the most significant results were replicated in our logistic regression, for the association between alcohol abuse among younger individuals [35-44 year-old multivariate OR: 38.30 (95% CI: 1.44-1012.56) and 45-54 year-old multivariate OR: 10.10 (95% CI: 1.06-96.46)] and for smokers [current smokers multivariate OR: 51.09 (95% CI: 3.49-748.01) and past smokers multivariate OR: 40.29 (95% CI: 2.37-685.93)]. Conclusion Individuals younger than 54 years and smokers showed a significant relation with harmful alcohol consumption, regardless of the ACS subtype. PMID:26131701

  18. Methods for testing theory and evaluating impact in randomized field trials

    PubMed Central

    Brown, C. Hendricks; Wang, Wei; Kellam, Sheppard G.; Muthén, Bengt O.; Petras, Hanno; Toyinbo, Peter; Poduska, Jeanne; Ialongo, Nicholas; Wyman, Peter A.; Chamberlain, Patricia; Sloboda, Zili; MacKinnon, David P.; Windham, Amy

    2008-01-01

    Randomized field trials provide unique opportunities to examine the effectiveness of an intervention in real world settings and to test and extend both theory of etiology and theory of intervention. These trials are designed not only to test for overall intervention impact but also to examine how impact varies as a function of individual level characteristics, context, and across time. Examination of such variation in impact requires analytical methods that take into account the trial’s multiple nested structure and the evolving changes in outcomes over time. The models that we describe here merge multilevel modeling with growth modeling, allowing for variation in impact to be represented through discrete mixtures—growth mixture models—and nonparametric smooth functions—generalized additive mixed models. These methods are part of an emerging class of multilevel growth mixture models, and we illustrate these with models that examine overall impact and variation in impact. In this paper, we define intent-to-treat analyses in group-randomized multilevel field trials and discuss appropriate ways to identify, examine, and test for variation in impact without inflating the Type I error rate. We describe how to make causal inferences more robust to misspecification of covariates in such analyses and how to summarize and present these interactive intervention effects clearly. Practical strategies for reducing model complexity, checking model fit, and handling missing data are discussed using six randomized field trials to show how these methods may be used across trials randomized at different levels. PMID:18215473

  19. [Evaluation on quality of large sample clinical trials of acupuncture in foreign countries].

    PubMed

    Liu, Mai-lan; Chang, Xiao-rong; Yuan, Yi-qin

    2014-10-01

    Following retrieving articles about foreign large sample clinical trials of acupuncture (more than 500 cases) from MEDLINE and EMBASE databases (1996-2012) by using keywords of "acupuncture" and "clinical trial", a quality analysis was carried out independently by two researchers. A total of 1373 papers were collected and 37 were considered to meet our preformulated standards in accordance with the principles and methods of evidence-based medicine. Majority of these 37 articles were from some advanced countries including Germany, USA, Japan, Demark, Australia, et al. Their paper quality and research quality are varied including the methodology, standards for diagnosis, inclusive and exclusive criteria, follow-up survey, economic effectiveness, adverse effects, acupoint application and syndrome differentiation of traditional Chinese medicine. Of the 37 papers, 17 are multiple center clinical trials, 18 are one center clinical trials, and 2 are not clear. Our Chinese researchers should pay more attention to foreign well-designed, large example, randomized controlled clinical trials and draw their matured experience and strong points to compensate our weak points and to improve our levels in clinical study on acupuncture treatment of clinical disorders. PMID:25518121

  20. A pilot randomised controlled trial to evaluate the feasibility and acceptability of the Baby Triple P Positive Parenting Programme in mothers with postnatal depression

    PubMed Central

    Tsivos, Zoe-Lydia; Calam, Rachel; Sanders, Matthew R; Wittkowski, Anja

    2015-01-01

    Few interventions for Postnatal Depression (PND) have focused on parenting difficulties; the aim of this research was to investigate the feasibility and evaluate a parenting intervention (Baby Triple P) in women with PND. This was a pilot randomised controlled trial (RCT) to evaluate and determine the feasibility of the newly developed Baby Triple P compared with treatment as usual (TAU) in women with PND. In all, 27 female participants aged from 18 to 45 years (mean age = 28.4 years, standard deviation (SD) = 6.1), with a primary diagnosis of major depression and an infant under 12 months (mean age = 6.2 months, SD = 3.2 months), were recruited from primary care trusts in Greater Manchester, United Kingdom. Participants were randomly allocated to receive either eight Baby Triple P sessions in addition to TAU or TAU only. Outcomes were assessed at post-treatment (Time 2) and 3 months post-treatment (Time 3). Self-report outcomes were as follows: Beck Depression Inventory, Oxford Happiness Inventory, What Being the Parent of a New Baby is Like, Postpartum Bonding Questionnaire and the Brief Parenting Beliefs Scale–baby version. An assessor-rated observational measure of mother–infant interaction, the CARE Index and measure of intervention acceptability were also completed. Significant improvements from Time 1 to Time 2 and Time 1 to Time 3 were observed across both groups. Although women allocated to Baby Triple P showed more favourable improvements, the between-group differences were not significant. However, the intervention was highly acceptable to women with PND. A large-scale RCT is indicated. PMID:24778436

  1. The Cost-Effectiveness of Wound-Edge Protection Devices Compared to Standard Care in Reducing Surgical Site Infection after Laparotomy: An Economic Evaluation alongside the ROSSINI Trial

    PubMed Central

    Gheorghe, Adrian; Roberts, Tracy E.; Pinkney, Thomas D.; Bartlett, David C.; Morton, Dion; Calvert, Melanie

    2014-01-01

    Background Wound-edge protection devices (WEPDs) have been used in surgery for more than 40 years to reduce surgical site infection (SSI). No economic evaluation of WEPDs against any comparator has ever been conducted. The aim of the paper was to assess whether WEPDs are cost-effective in reducing SSI compared to standard care alone in the United Kingdom. Methods and Findings An economic evaluation was conducted alongside the ROSSINI trial. The study perspective was that of the UK National Health Service and the time horizon was 30 days post-operatively. The study was conducted in 21 UK hospitals. 760 patients undergoing laparotomy were randomised to either WEPD or standard care and 735 were included in the primary analysis. The main economic outcome was cost-effectiveness based on incremental cost (£) per quality adjusted life year (QALY) gained. Patients in the WEPD arm accessed health care worth £5,420 on average and gained 0.02131 QALYs, compared to £5,130 and 0.02133 QALYs gained in the standard care arm. The WEPD strategy was more costly and equally effective compared to standard care, but there was significant uncertainty around incremental costs and QALYs. The findings were robust to a range of sensitivity analyses. Conclusions There is no evidence to suggest that WEPDs can be considered a cost effective device to reduce SSI. Their continued use is a waste of limited health care resources. PMID:24748154

  2. Plant Line Trial Evaluation of Viable Non-Chromium Passivation Systems for Electrolytin Tinplate, ETP (TRP 9911)

    SciTech Connect

    John A. Sinsel

    2003-06-30

    Plant trial evaluations have been completed for two zirconium-based, non-chromium passivation systems previously identified as possible alternatives to cathodic dichromate (CDC) passivation for electrolytic tinplate (ETP). These trials were done on a commercial electrolytic tin plating line at Weirton Steel and extensive evaluations of the materials resulting from these trials have been completed. All this was accomplished as a collaborative effort under the AISI Technology Roadmap Program and was executed by seven North American Tin Mill Products producers [Bethlehem Steel (now acquired by International Steel Group (ISG)), Dofasco Inc., National Steel (now acquired by U.S. Steel), U.S. Steel, USS-Posco, Weirton Steel, and Wheeling-Pittsburgh Steel] with funding partially from the Department of Energy (DOE) and partially on an equal cost sharing basis among project participants. The initial phases of this project involved optimization of application procedures for the non-chromium systems in the laboratories at Bethlehem Steel and Betz Dearborn followed by extensive testing with various lacquer formulations and food simulants in the laboratories at Valspar and PPG. Work was also completed at Dofasco and Weirton Steel to develop methods to prevent precipitation of insoluble solids as a function of time from the zirconate system. The results of this testing indicated that sulfide staining characteristics for the non-chromium passivation systems could be minimized but not totally eliminated and neither system was found to perform quite as good, in this respect, as the standard CDC system. As for the stability of zirconate treatment, a method was developed to stabilize this system for a sufficient period of time to conduct plant trial evaluations but, working with a major supplier of zirconium orthosulfate, a method for long term stabilization is still under development.

  3. Joint protection and hand exercises for hand osteoarthritis: an economic evaluation comparing methods for the analysis of factorial trials

    PubMed Central

    Oppong, Raymond; Nicholls, Elaine; Whitehurst, David G. T.; Hill, Susan; Hammond, Alison; Hay, Elaine M.; Dziedzic, Krysia

    2015-01-01

    Objectives. Evidence regarding the cost-effectiveness of joint protection and hand exercises for the management of hand OA is not well established. The primary aim of this study is to assess the cost-effectiveness (cost-utility) of these management options. In addition, given the absence of consensus regarding the conduct of economic evaluation alongside factorial trials, we compare different analytical methodologies. Methods. A trial-based economic evaluation to assess the cost-utility of joint protection only, hand exercises only and joint protection plus hand exercises compared with leaflet and advice was undertaken over a 12 month period from a UK National Health Service perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were calculated for each trial arm. Incremental cost-effectiveness ratios (ICERs) were estimated and cost-effectiveness acceptability curves were constructed. The base case analysis used a within-the-table analysis methodology. Two further methods were explored: the at-the-margins approach and a regression-based approach with or without an interaction term. Results. Mean costs (QALYs) were £58.46 (s.d. 0.662) for leaflet and advice, £92.12 (s.d. 0.659) for joint protection, £64.51 (s.d. 0.681) for hand exercises and £112.38 (s.d. 0.658) for joint protection plus hand exercises. In the base case, hand exercises were the cost-effective option, with an ICER of £318 per QALY gained. Hand exercises remained the most cost-effective management strategy when adopting alternative methodological approaches. Conclusion. This is the first trial evaluating the cost-effectiveness of occupational therapy-supported approaches to self-management for hand OA. Our findings showed that hand exercises were the most cost-effective option. PMID:25339642

  4. Neurocognitive functioning and quality of life in patients with recurrent malignant gliomas treated on a phase Ib trial evaluating topotecan by convection-enhanced delivery

    PubMed Central

    Oberg, Jennifer A.; Dave, Amie N.; Bruce, Jeffrey N.; Sands, Stephen A.

    2014-01-01

    Background Malignant gliomas are highly proliferative, invasive tumors that are resistant to conventional treatment, and disease progression is often accompanied by physical and mental debilitation. Neurocognitive functioning (NCF) and quality of life (QoL) were evaluated as part of a prospective phase Ib dose-escalation study of topotecan by convection-enhanced delivery (CED) for adult patients with recurrent malignant gliomas. Methods Sixteen patients were enrolled, and NC