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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

    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

  5. 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

  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. 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

  15. 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

  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. 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

  17. 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

  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. 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

  1. 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

  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. 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…

  4. 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

  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. 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

  8. 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

  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. 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

  5. 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

  6. 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

  7. 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…

  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. 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...

  11. 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.

  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. 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

  14. 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

  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. 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

  17. 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

  18. 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

  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. 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…

  10. 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…

  11. 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...

  12. 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…

  13. 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…

  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. Theory-Driven Process Evaluation of a Complementary Feeding Trial in Four Countries

    ERIC Educational Resources Information Center

    Newman, Jamie E.; Garces, Ana; Mazariegos, Manolo; Hambidge, K. Michael; Manasyan, Albert; Tshefu, Antoinette; Lokangaka, Adrien; Sami, Neelofar; Carlo, Waldemar A.; Bose, Carl L.; Pasha, Omrana; Goco, Norman; Chomba, Elwyn; Goldenberg, Robert L.; Wright, Linda L.; Koso-Thomas, Marion; Krebs, Nancy F.

    2014-01-01

    We conducted a theory-driven process evaluation of a cluster randomized controlled trial comparing two types of complementary feeding (meat versus fortified cereal) on infant growth in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo. We examined process evaluation indicators for the entire study cohort (N = 1236) using chi-square…

  4. 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…

  5. 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

  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. 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…

  11. 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…

  12. 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…

  13. 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…

  14. 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…

  15. 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).…

  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. 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

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

    NASA Technical Reports Server (NTRS)

    Long, Victoria

    2011-01-01

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

  20. 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. 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

  3. 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

  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. [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

  8. 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

  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. 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

  12. 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

  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. 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…

  19. 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…

  20. 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)

  1. 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…

  2. 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...

  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. 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

  12. 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

  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. 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

  16. [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

  17. 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

  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