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Sample records for evaluation post trial

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2011-10-01

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

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

    PubMed

    Kondo, Shunsuke; Hosoi, Hiroko; Hashimoto, Jun

    2017-03-07

    Investigator-initiated trials (IITs) are important aspects of medical research and have contributed substantially to modern oncology. IITs using post-approval drugs have been conducted by domestic institutions in Japan. Data from this study were obtained by all IITs registered clinical trials for five cancers (lung, colorectal cancer, gastric cancer, liver cancer, and breast cancer) using drugs approved from 1999 to 2009 in Japan. The Kaplan-Meier method, analysis of variance (ANOVA), and Kruskal-Wallis test were used to estimate time to enrolment completion (TTEC) and time to enrolment per patient (TTEP). Of 1,222 trials eligible for analysis, 465 trials (38%) completed enrolment to the studies, and 203 trials (17%) published results. In the distribution according to trial phase, 98 (8%) were phase I, 1,058 (87%) were phase I/II + II, and 66 (5%) were phase II/III + III. The accrual achievement and publication rates were higher in late-phase than in early-phase trials. The median TTEC was 1,387 days (95% confidence interval [CI], 1,302 to 1,472). The median TTEP was 38.5 days (95% CI, 34.5 to 42.5). The median TTEC and TTEP were significantly different in each trial phase (P < 0.01), funding source (P < 0.01), and publication status (median TTEC published trials vs. unpublished trial; 720 days vs. 1,672 days, median TTEP; 16 days vs. 55.8 days; P < 0.001). Many IITs using approved cancer drugs have been conducted; however, the quality of the clinical trials was low in terms of accrual achievement, publication rate, and time to publication of trial results. This article is protected by copyright. All rights reserved.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    Lopalco, Pier Luigi; DeStefano, Frank

    2015-03-24

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

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

    PubMed

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

    2016-11-01

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

  7. 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

  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.

  9. Evaluation Using Sequential Trials Methods.

    ERIC Educational Resources Information Center

    Cohen, Mark E.; Ralls, Stephen A.

    1986-01-01

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

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

    DTIC Science & Technology

    2010-05-01

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

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

    PubMed

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

    2014-09-01

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

  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. 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.

  14. 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

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

    PubMed Central

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

    2017-01-01

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

  16. 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

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

    PubMed

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

    2015-09-01

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

  18. 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…

  19. 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.

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  2. Review of Building Quality Using Post Occupancy Evaluation.

    ERIC Educational Resources Information Center

    Watson, Chris

    2003-01-01

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

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

    ERIC Educational Resources Information Center

    Kelly, P. J.

    1972-01-01

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

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

    PubMed

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

    2012-03-30

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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  6. 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

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

    ERIC Educational Resources Information Center

    Wolf, Robert L.

    1975-01-01

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

  8. 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

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

    PubMed

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

    2017-04-04

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

  10. 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

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

    PubMed Central

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

    2015-01-01

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

  12. [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".

  13. 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…

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

    PubMed

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

    2015-12-01

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

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

    SciTech Connect

    Logan, R.C.

    1999-06-22

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

  16. 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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2011-10-01

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

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

    PubMed

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

    2017-04-06

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

  20. [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.

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

    PubMed Central

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

    2013-01-01

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

  2. 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.

  3. 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

  4. 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

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

    PubMed Central

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

    2014-01-01

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

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

    DTIC Science & Technology

    2011-05-01

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

  7. Frequentist evaluation of group sequential clinical trial designs.

    PubMed

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

    2007-12-10

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

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

    PubMed

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

    2004-01-01

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

  9. 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

  10. 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

  11. 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

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

    PubMed

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

    2014-09-01

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

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

    PubMed

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

    2015-02-01

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

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

    DTIC Science & Technology

    2014-01-14

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

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

    PubMed Central

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

    2010-01-01

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

  16. 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

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

    PubMed Central

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

    2014-01-01

    Background: Air way intubation for general anesthesia usually leads to sore throat after surgery. Ketamine plays an important role to block a number of receptors related to pain. Benzydamine hydrochloride is a non-steroidal anti-inflammatory drug that has been used to improve oropharyngeal disorders. In this study, it was intended to compare the effect of gargling different solutions before the surgery on post-operative sore throat (POST) in patients who underwent general anesthesia for hysterectomy. Materials and Methods: A total of 60 patients who underwent the elective hysterectomy were entered to the randomized controlled trial regarding to the eligibility criteria. Patients were simply randomly allocated to three groups and received one code. Every code was representative for a specific drug: 20 cc normal saline (control group) or 1.5 mg benzydamine in 20 cc solution or 20 mg ketamine in 20 cc solutions. All the research teams were blinded to the received solutions. POST was evaluated with numerical rating scale. The data were entered to SPSS software and analysis of variance (ANOVA) and Kruskal-Wallis one-way analysis of variance test, were performed. Results: The mean ages of ketamine, benzydamine, and normal saline recipients were not significantly different. The trend of the severity of sore throat during the first 24 h after the operation in ketamine recipients was significantly lower than the other two groups (P < 0.001). Conclusion: The pain scale after surgery was reduced by using both ketamine and benzydamine, but the ketamine effect was more noticeable. PMID:25371873

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

    DTIC Science & Technology

    2011-12-01

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

  19. 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.

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

    PubMed

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

    2016-12-06

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

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

    PubMed Central

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

    2016-01-01

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

  2. 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…

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

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

    2013-01-01

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

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

    PubMed

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

    2016-09-22

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

  6. 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

  7. 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

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

    PubMed

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

    2014-09-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

    Omari, Sana; Woodcock, Andree

    2012-01-01

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

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

    PubMed Central

    Sweis, Randy F.; Drazer, Michael W.

    2016-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2017-03-02

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

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

    PubMed Central

    2012-01-01

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

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

    NASA Technical Reports Server (NTRS)

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

    1979-01-01

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

  16. 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

  17. 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...

  18. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  19. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  20. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  1. 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…

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

    PubMed Central

    Ichida, Takashi; Kusano, Fumihiko; Sakai, Yoshinori

    2016-01-01

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2002-01-01

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

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

    PubMed

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

    1996-08-15

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

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

    PubMed Central

    VanRullen, Rufin

    2016-01-01

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

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

    PubMed

    Dippel, F-W

    2008-08-01

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

  10. 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

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

    PubMed

    Sofaer, Neema; Strech, Daniel

    2011-07-01

    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.

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

    PubMed Central

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

    1984-01-01

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

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

    PubMed Central

    Amani, Soroush; Kheiri, Soleyman

    2015-01-01

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

  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. 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

  16. 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

  17. 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

  18. 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

  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

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

    2015-10-01

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

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

    PubMed

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

    2015-02-04

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

  1. 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…

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

    PubMed

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

    2008-09-01

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

  3. Evaluating cognitive effort in a randomized controlled trial.

    PubMed

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

    2016-09-01

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

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

    PubMed Central

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

    2010-01-01

    Purpose Post-activation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. Experimental Design National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, non-pediatric Phase I, I/II, II, and III studies activated between 2000–2004 were investigated for an eight-year period (n=419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios, controlling for study phase and size of expected accruals. Results 37.9 percent (n=221) of CTEP-approved oncology trials failed to attain the minimum accrual goals, with 70.8 percent (n=14) of Phase III trials resulting in poor accrual. A total of 16474 patients (42.5% of accruals) accrued to those studies that were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months development were significantly more likely to achieve accrual goals (odds ratio, 2.15; 95% CI, 1.29–3.57, P=0.003) than trials with the median development time of 12–18 months. Trials requiring a development time of greater than 24 months were significantly less likely of achieving accrual goals (odds ratio, 0.40; 95% CI, 0.20–0.78, P=0.011) than trials with the median development time. Conclusions A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. PMID:21062929

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

    PubMed

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

    2013-09-01

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

  6. 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

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

    PubMed

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

    2010-08-01

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

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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…

  13. 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.

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

    PubMed

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

    2012-09-13

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

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

    PubMed Central

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

    2016-01-01

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

  16. 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…

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

    PubMed Central

    Kashefinejad, Mohamad; Harandi, Azade; Bijani, Ali

    2016-01-01

    Objectives: Pain is an unpleasant outcome of endodontic treatment that can be unbearable to patients. Instrumentation techniques may affect the frequency and intensity of post-endodontic pain. This study aimed to compare single visit post endodontic pain using Mtwo (NiTi) rotary and hand K-file instruments. Materials and Methods: In this randomized controlled trial, 60 teeth with symptomatic irreversible pulpitis in 53 patients were selected and randomly assigned into two groups of 30 teeth. In group A, the root canals were prepared with Mtwo (NiTi) rotary instruments. In group B, the root canals were prepared with hand K-file instruments. Pain assessment was implemented using visual analog scale (VAS) at four, eight, 12 and 24 hours after treatment. The acquired data were analyzed using chi-square, Mann-Whitney U and Student’s t-test (P<0.05). Results: Patients treated with rotary instruments experienced significantly less post-endodontic pain than those treated with hand instruments (P<0.001). Conclusions: The use of Mtwo (NiTi) rotary instruments in root canal preparation contributed to lower incidence of postoperative pain than hand K-files. PMID:27536323

  18. 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

  19. 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...

  20. Assessment of the Reliability and Validity of the Discrete-Trials Teaching Evaluation Form

    ERIC Educational Resources Information Center

    Babel, Danielle A.; Martin, Garry L.; Fazzio, Daniela; Arnal, Lindsay; Thomson, Kendra

    2008-01-01

    Discrete-trials teaching (DTT) is a frequently used method for implementing Applied Behavior Analysis treatment with children with autism. Fazzio, Arnal, and Martin (2007) developed a 21-component checklist, the Discrete-Trials Teaching Evaluation Form (DTTEF), for assessing instructors conducting DTT. In Phase 1 of this research, three experts on…

  1. 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…

  2. 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.

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

  4. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Drugs Intended... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and...

  5. 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

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

    PubMed

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

    2013-07-01

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

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

    PubMed Central

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

    2009-01-01

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

  8. 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

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

    ERIC Educational Resources Information Center

    Hemphill, Leaunda S.; Hemphill, Hoyet H.

    2007-01-01

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

  10. 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…

  11. Evaluation of Post-Arrival Programs and Services.

    ERIC Educational Resources Information Center

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

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

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

    ERIC Educational Resources Information Center

    Holloway, Jerry; Moke, Paul

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

  13. 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…

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

    PubMed

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

    2013-08-01

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

  15. 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

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

    PubMed

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

    2015-06-01

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

  17. Evaluation of a Blocked-Trials Procedure to Establish Complex Stimulus Control over Intraverbal Responses in Children with Autism

    ERIC Educational Resources Information Center

    Ingvarsson, Einar T.; Kramer, Rachel L.; Carp, Charlotte L.; Pétursdóttir, Anna I.; Macias, Heather

    2016-01-01

    We evaluated the use of a blocked-trials procedure to establish complex stimulus control over intraverbal responses. The participants were four young boys with a diagnosis of autism who had struggled to master intraverbals. The blocked-trials procedures involved presentation of stimuli in separate trial blocks. The trial blocks gradually reduced…

  18. 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

  19. 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

  20. 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.

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

    PubMed

    Pigret, D; Jankowski, R

    1996-03-01

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

  2. Weight Lifting and Physical Function Among Survivors of Breast Cancer: A Post Hoc Analysis of a Randomized Controlled Trial

    PubMed Central

    Brown, Justin C.; Schmitz, Kathryn H.

    2015-01-01

    Purpose Survivors of breast cancer may experience deterioration of physical function. This is important because poor physical function may be associated with premature mortality, injurious falls, bone fracture, and disability. We conducted a post hoc analysis to explore the potential efficacy of slowly progressive weight lifting to reduce the incidence of physical function deterioration among survivors of breast cancer. Methods Between October 2005 and August 2008, we conducted a single-blind, 12-month, randomized controlled trial of twice-per-week slowly progressive weight lifting or standard care among 295 survivors of nonmetastatic breast cancer. In this post hoc analysis of data from the Physical Activity and Lymphedema Trial, we examined incident deterioration of physical function after 12 months, defined as a ≥ 10-point decrease in the physical function subscale of the Medical Outcomes Short-Form 36-item questionnaire. Results The proportion of participants who experienced incident physical function deterioration after 12 months was 16.3% (24/147) in the control group and 8.1% (12/148) in the weight lifting group (relative risk, 0.49; 95% CI, 0.25 to 0.96; P = .04). No serious or unexpected adverse events occurred that were related to weight lifting. Conclusion Slowly progressive weight lifting compared with standard care reduced the incidence of physical function deterioration among survivors of breast cancer. These data are hypothesis generating. Future studies should directly compare the efficacy of weight lifting with other modalities of exercise, such as brisk walking, to appropriately inform the development of a confirmatory study designed to preserve physical function among survivors of breast cancer. PMID:25964257

  3. Predictors of post-treatment relapse to smoking in successful quitters: Pooled data from two phase III varenicline trials

    PubMed Central

    Heffner, Jaimee L.; Lee, Theodore C.; Arteaga, Carmen; Anthenelli, Robert M.

    2010-01-01

    Background Identifying predictors of smoking relapse helps to elucidate the challenges of long-term smoking cessation and provides direction for improved treatment development. Methods In this post hoc data analysis, we examined predictors of relapse from end-of-treatment (week 13) through 1-year follow-up (week 52) for treatment-responding participants who achieved the primary efficacy endpoint of 4-week continuous abstinence (weeks 9–12), during two phase III varenicline trials. Results Of 626 smokers classified as treatment responders for all treatment groups across both trials, 301 (48%) relapsed during follow-up (weeks 13–52). The odds of relapsing were almost 5 times greater (odds ratio [OR]=4.92, 95% confidence interval [CI]: 2.77–8.97; p<.001) for treatment responders who did not initiate continuous abstinence until the final 4 weeks of the treatment period compared with those who initiated continuous abstinence by their quit date. Participants who reported >30 days of abstinence during the year prior to study entry were significantly more likely to relapse than those who reported 0 days of abstinence (OR=2.38, 95% CI: 1.17–5.04; p=.013). Conclusion Results of these analyses suggest that the ability to quit smoking on the initial quit date and maintain abstinence throughout the treatment period is a good prognostic indicator for long-term abstinence. The relationship between post-treatment relapse and longer pretreatment periods of abstinence is counterintuitive, yet not without precedence in the literature. PMID:20071105

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

    PubMed

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

    2011-10-01

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

  5. Standardized ultrasound evaluation of carotid stenosis for clinical trials: University of Washington Ultrasound Reading Center

    PubMed Central

    2010-01-01

    Introduction Serial monitoring of patients participating in clinical trials of carotid artery therapy requires noninvasive precision methods that are inexpensive, safe and widely available. Noninvasive ultrasonic duplex Doppler velocimetry provides a precision method that can be used for recruitment qualification, pre-treatment classification and post treatment surveillance for remodeling and restenosis. The University of Washington Ultrasound Reading Center (UWURC) provides a uniform examination protocol and interpretation of duplex Doppler velocity measurements. Methods Doppler waveforms from 6 locations along the common carotid and internal carotid artery path to the brain plus the external carotid and vertebral arteries on each side using a Doppler examination angle of 60 degrees are evaluated. The UWURC verifies all measurements against the images and waveforms for the database, which includes pre-procedure, post-procedure and annual follow-up examinations. Doppler angle alignment errors greater than 3 degrees and Doppler velocity measurement errors greater than 0.05 m/s are corrected. Results Angle adjusted Doppler velocity measurements produce higher values when higher Doppler examination angles are used. The definition of peak systolic velocity varies between examiners when spectral broadening due to turbulence is present. Examples of measurements are shown. Discussion Although ultrasonic duplex Doppler methods are widely used in carotid artery diagnosis, there is disagreement about how the examinations should be performed and how the results should be validated. In clinical trails, a centralized reading center can unify the methods. Because the goals of research examinations are different from those of clinical examinations, screening and diagnostic clinical examinations may require fewer velocity measurements. PMID:20822530

  6. 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.

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

    DTIC Science & Technology

    1990-12-01

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

  8. 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...

  9. 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

  10. A randomized, double-blind, placebo-controlled trial comparing pethidine to metamizol for treatment of post-anaesthetic shivering

    PubMed Central

    MONSÓ, A.; RIUDEUBAS, J.; BARBAL, F.; LAPORTE, J-R.; ARNAU, J. M.

    1996-01-01

    1Shivering is frequent during the post-anaesthetic recovery period, and there is no clear consensus about the best strategy for its treatment. We tested the efficacy of two commonly used analgesic drugs, pethidine and metamizol. 2A randomized, double-blind, placebo-controlled clinical trial was performed, including 104 adult patients who presented with post-anaesthetic shivering during the recovery from general anaesthesia. They were randomized to receive placebo (n=32), metamizol 25 mg kg−1 (n=37), or pethidine 0.4 mg kg−1 (n=35). The response to treatment was assessed 5, 15 and 45 min after drug administration, and the main outcome variable was complete suppression of shivering. 3The efficacy at 5, 15 and 45 min was as follows: placebo 6%, 16% and 37%; metamizol 13.5%, 32% and 76%, and pethidine 89%, 91% and 89%. With both active drugs the efficacy at all three time intervals was significantly higher than that with placebo (P<0.05). The differences (at 5 and 15, but not at 45 min) between pethidine and metamizol were statistically significant (P<0.05). Both drugs were well tolerated. 4The persistence of shivering at 45 min in two thirds of placebo-treated patients indicates that drug treatment is worthwhile; metamizol produces a better post-anaesthetic shivering response than placebo, especially 15 and 45 min after drug administration; the efficacy of pethidine was the highest and the response to it appeared more quickly; however, at 45 min it was similar to that observed with metamizol. 5Both metamizol and pethidine suppress postanaesthetic shivering, but the latter induces a quicker and more reliable response. PMID:8877020

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

    PubMed Central

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

    2012-01-01

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

  12. Daily Fluid Intake and Outcomes in Kidney Recipients: Post hoc analysis from the randomized ABCAN trial

    PubMed Central

    Weber, M; Berglund, D; Reule, S; Jackson, S; Matas, AJ; Ibrahim, HN

    2015-01-01

    Generous and even excessive fluid intake is routinely recommended to kidney transplant recipients despite minimal evidence to support this practice. We hypothesized that increased fluid intake, ascertained by 24-hour urine volume output, may adversely affect graft outcomes as it would impose an extra workload on a limited number of nephrons. Kidney transplant recipients who were randomized to losartan vs. placebo in the ABCAN trial (n=153) underwent baseline, five-year biopsies and annual iothalamate GFR assessment. Recipients with higher urine volume at randomization had higher urinary sodium and also higher urinary protein. The proportion using diuretics or CNI based regimens were similar across urinary volume tertiles. The highest urinary volume tertile (>2.56 L/day) did not predict the development of interstitial volume doubling or ESRD from IF/TA (OR=3.52, 95% CI 0.4, 38.15, p=0.26), interstitial volume doubling or all-cause ESRD (OR=7.04, 95% CI 0.66, 74.87, p=0.10), and was not associated with the conventional endpoint of doubling serum creatinine, all cause ESRD, or death (OR=0.89, 95% CI 0.21, 3.71, p=0.87). These results suggest that the current practice of liberal fluid intake may not be beneficial in low risk and mostly Caucasian transplant recipients. PMID:25619874

  13. 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)

  14. 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,…

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

    ERIC Educational Resources Information Center

    Harmon, Marcel; Larroque, Andre; Maniktala, Nate

    2012-01-01

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

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

    PubMed

    Liu, Huan; Xie, Yanming

    2011-10-01

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

  17. Use of band-pass filter analysis to evaluate outcomes in an antidepressant trial for treatment resistant patients.

    PubMed

    Targum, Steven D; Burch, Daniel J; Asgharnejad, Mahnaz; Petersen, Timothy; Gomeni, Roberto; Fava, Maurizio

    2014-08-01

    Band-pass filtering is a novel statistical methodology that proposes that filtering out data from trial sites generating non-plausible high or low levels of placebo response can yield a more accurate effect size and greater separation of active drug (when efficacious) from placebo. We applied band-pass filters to re-analyze data from a negative antidepressant trial (NCT00739908) evaluating CX157 (a reversible and selective monoamine oxidase inhibitor-A) versus placebo. 360 patients from 29 trial sites were randomized to either CX157 treatment (n=182) or placebo (n=178). We applied two filters of<3 or>7 points (filter #1) or<3 and>9 points (filter #2) mean change of the total MADRS placebo scores for each site. Trial sites that had mean placebo MADRS score changes exceeding the boundaries of these band-pass filter thresholds were considered non-informative and all of the data from these sites were excluded from the post-hoc re-analysis. The two band-pass filters reduced the sample of informative patients from 353 patients in the mITT population to 62 in filter #1 and 152 in the filter #2 group. The placebo response was reduced from 31.1% in the mITT population to 9.4% with filter #1 and 20.8% with filter #2. MMRM analysis revealed a non-statistically significant trend of p=0.13 and 0.16 for the two filters in contrast to the mITT population (p= 0.58). Our findings support the band-pass filter hypothesis and highlight issues related to site-based scoring variability and inappropriate subject selection that may contribute to trial failure.

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

    PubMed Central

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

    2017-01-01

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

  19. 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

  20. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis

    PubMed Central

    2010-01-01

    inhibits physical function and influences patient perception of disease severity in hand OA. These results also suggest that any intervention to relieve the pain of hand OA may improve function and patient perception of disease severity, despite the absence of a disease-modifying mechanism of action. Trial registration Clinicaltrials.gov NCT00171652, NCT00171665. PMID:20064249

  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. Clinical uses of melatonin: evaluation of human trials.

    PubMed

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

    2010-01-01

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

  3. Comparison of epidural oxycodone and epidural morphine for post-caesarean section analgesia: A randomised controlled trial

    PubMed Central

    Sng, Ban Leong; Kwok, Sarah Carol; Mathur, Deepak; Ithnin, Farida; Newton-Dunn, Clare; Assam, Pryseley Nkouibert; Sultana, Rehena; Sia, Alex Tiong Heng

    2016-01-01

    Background and Aims: Epidural morphine after caesarean section may cause moderate to severe pruritus in women. Epidural oxycodone has been shown in non-obstetric trials to reduce pruritus when compared to morphine. We hypothesised that epidural oxycodone may reduce pruritus after caesarean section. Methods: A randomised controlled trial was conducted in pregnant women at term who underwent caesarean section with combined spinal-epidural technique initiated with intrathecal fentanyl 15 μg. Women received either epidural morphine 3 mg or epidural oxycodone 3 mg via the epidural catheter after delivery. The primary outcome was the incidence of pruritus at 24 h after caesarean section. The secondary outcomes were the pruritus scores, treatment for post-operative nausea and vomiting (PONV), pain scores and maternal satisfaction. Results: One hundred women were randomised (group oxycodone O = 50, morphine M = 50). There was no difference between Group O and M in the incidence of pruritus (n [%] 28 [56%] vs. 31 [62%], P = 0.68) and the worst pruritus scores (mean [standard deviation] 2.6 (2.8) vs. 3.3 [3.1], P = 0.23), respectively. Both groups had similar pain scores at rest (2.7 [2.3] vs. 2.0 [2.7], P = 0.16) and sitting up (5.0 [2.3] vs. 4.6 [2.4], P = 0.38) at 24 h. Pruritus scores were lower at 4–8, 8–12 and 12–24 h with oxycodone, but pain scores were higher. Both groups had a similar need for treatment of PONV and maternal satisfaction with analgesia. Conclusion: There was no difference in the incidence of pruritus at 24 h between epidural oxycodone and morphine. However, pruritus scores were lower with oxycodone between 4 and 24 h after surgery with higher pain scores in the same period. PMID:27053782

  4. The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database.

    PubMed

    Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2017-01-01

    In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P <0.001) using non-randomized assignment (90.1% vs. 66.7%, P <0.001) than other oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P <0.001). These findings raise concerns that clinical trials evaluating PET imaging in oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials.

  5. The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database

    PubMed Central

    Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2017-01-01

    In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P <0.001) using non-randomized assignment (90.1% vs. 66.7%, P <0.001) than other oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P <0.001). These findings raise concerns that clinical trials evaluating PET imaging in oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials. PMID:28042342

  6. 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…

  7. Impact of intercostal paravertebral neurectomy on post thoracotomy pain syndrome after thoracotomy in lung cancer patients: a randomized controlled trial

    PubMed Central

    Althaus, Astrid; Poels, Marcel; Joppich, Robin; Lefering, Rolf; Wappler, Frank; Windisch, Wolfram; Ludwig, Corinna; Stoelben, Erich

    2016-01-01

    Background Thoracotomy leads to chronic neuropathic pain in up to 50% of patients and is responsible for an impaired quality of life. Intercostal nerve injury has been suggested to be responsible for this pain. In the present study the impact of paravertebral intercostal neurectomy on post thoracotomy pain was assessed. Methods In this single center parallel-group randomized controlled trial patients underwent muscle sparing anterolateral thoracotomy and anatomical lung resection for lung cancer. A subcostal approach was used for thoracotomy with single paravertebral neurectomy being performed at the beginning of the procedure at the level of the retracted intercostal space. For documentation of neuropathic pain the Leeds Assessment Score for Neuropathic Symptoms and Signs (LANSS) was used postoperatively. The primary endpoint was defined as LANSS ≥12 points on day 120. In addition, the numeric pain rating scale (NRS) was used to score pain intensity. Results Out of 172 patients initially randomized 161 patients were investigated following intraoperative and postoperative drop-out criteria. All patients required anatomical lung resection via thoracotomy. Five patients were lost for follow up. For the remaining 156 patients there was no difference between the two groups with regard to LANSS ≥12: 26.6% in patients with neurectomy and 28.8% in control-subjects (P=0.78). In addition, the NSR score at day 120 did not differ significantly at rest and during activity between the two groups (at rest: 21.7% vs. 15.8% P=0.439; activity: 24.5% vs. 21.9% P=0.735). Conclusions Neurectomy was not shown to reduce the post thoracotomy pain syndrome in patients with anatomical lung resection following anterolateral muscle sparing thoracotomy. PMID:27746994

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

    PubMed Central

    Schiavetti, R.; Sannino, G.

    2012-01-01

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

  9. Evaluation of Low Level Laser Therapy on Pain Perception Following Orthodontic Elastomeric Separation: A Randomized Controlled Trial

    PubMed Central

    Almallah, Mai M.E.; Almahdi, Wael H.

    2016-01-01

    Introduction Periodontal pain caused by elastomeric separators is a very common problem in the commencement of orthodontic treatment. Previous studies have shown good results in reducing this pain by Low Level Laser Therapy (LLLT) and different protocols of application have been suggested in the literature. Aim This trial aimed to evaluate LLLT on managing orthodontic pain caused by elastomeric separators and to compare single versus double irradiation in possible pain reduction. Materials and Methods A clinical randomized compound (parallel-group and split-mouth design) trial was conducted on 36 patients between 12 and 26 years of age. Elastomeric separators were placed at the mesial and distal surfaces of the first molars in one jaw (upper or lower) for each patient and in only one side of the mouth (the other side served as the placebo side). The trial had two groups: the first group received single irradiation of LLLT [Gallium Aluminum Arsenide (GaAlAs): 830 nm, 4J/cm2, 100mW] immediately after separators insertion, where as the second group received double irradiation immediately after separators insertion and after 24hours. All patients were instructed to rate the level of pain at 1, 6, 24, 48, 96 hours on a Visual Analog Scale (VAS). The student ‘t’ tests, repeated measures ANOVA and LSD post-hoc tests were employed. Results LLLT was successful in reducing post-separation pain when the experimental side was compared to the placebo side at all assessment times in each group (p<0.05). There were no statistically significant differences between single and double irradiation groups in terms of pain reduction (p>0.05). Conclusion GaAlAs LLLT application reduced early orthodontic pain caused by elastomeric separators by single or double irradiation. PMID:28050498

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

    PubMed Central

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

    2016-01-01

    Purpose Intermittent androgen deprivation (IAD) has been widely tested in prostate cancer. However, phase III trials testing continuous androgen deprivation (CAD) versus IAD have reached inconclusive and seemingly contradictory results. Different design and conduct issues must be critically evaluated to better interpret the results. Patients and Methods Seven published phase III trials were examined for prespecified design and outcomes. Treatment specifications; primary end point; superiority versus noninferiority design assumptions, including magnitude of assumed versus observed noninferiority margin (NIM); duration of follow-up; and quality-of-life (QOL) outcomes were considered in terms of the results and conclusions reported. Results Five trials had a superiority and three had a noninferiority primary hypothesis. Only three trials had a uniform population and overall survival (OS) end point. All trials observed better outcomes in terms of OS and progression-free survival (PFS) than assumed at time of study design, translating into prespecified NIMs or hazard ratios that reflected larger absolute differences in OS or PFS between arms. Lower-than-expected event rates also reduced statistical power for the trials. Other factors, including length of follow-up, cause of death, QOL, and primary end point, and their impact on trial interpretation are discussed. Conclusion No trial to date has demonstrated survival superiority of IAD compared with CAD. Trials concluding IAD is noninferior to CAD were based on wide NIMs that included clinically important survival differences, not likely to be considered comparable by physicians or patients. Interim analyses relying on short follow-up and including a majority of non–prostate cancer deaths will favor a noninferiority conclusion and should be interpreted cautiously. Adequate follow-up is required to ensure capture of prostate cancer deaths in both superiority and noninferiority trials. PMID:26552421

  11. Is there a need for cervical collar usage post anterior cervical decompression and fusion using interbody cages? A randomized controlled pilot trial.

    PubMed

    Abbott, Allan; Halvorsen, Marie; Dedering, Asa

    2013-05-01

    Anterior cervical discectomy and fusion (ACDF) is a common surgical intervention for radiculopathy resulting from degenerative cervical spine conditions. Post-surgical cervical collar use is believed to reduce post-operative pain, provide the patient with a sense of security during activities of daily living and even reduce rates of non-fusion. This prospective randomized controlled pilot trial investigates trial design feasibility in relation to prospective physical, functional, and quality of life-related outcomes of patients undergoing ACDF with interbody cage, with (n = 17) and without (n = 16) post-operative cervical collar usage. Results show that the sample provides sufficient statistical power to show that the use of a rigid cervical collar during 6 post-operative weeks is associated with significantly lower levels of neck disability index after 6 weeks and significantly lower levels of prospective neck pain. To investigate causal quality of life or fusion rate outcomes, sample size needs to be increased at least fourfold and optimally sixfold when accounting for data loss in prospective follow-up. The study suggests that post-surgical cervical collar usage may help certain patients cope with initial post-operative pain and disability.

  12. Descriptive analysis of a 1:1 physiotherapy outpatient intervention post primary lumbar discectomy: one arm of a small-scale parallel randomised controlled trial across two UK sites

    PubMed Central

    Rushton, A; Calcutt, A; Heneghan, N; Heap, A; White, L; Goodwin, P

    2016-01-01

    Objective There is a lack of high-quality evidence for physiotherapy post lumbar discectomy. Substantial heterogeneity in treatment effects may be explained by variation in quality, administration and components of interventions. An optimised physiotherapy intervention may reduce heterogeneity and improve patient benefit. The objective was to describe, analyse and evaluate an optimised 1:1 physiotherapy outpatient intervention for patients following primary lumbar discectomy, to provide preliminary insights. Design A descriptive analysis of the intervention embedded within an external pilot and feasibility trial. Setting Two UK spinal centres. Participants Participants aged ≥18; post primary, single level, lumbar discectomy were recruited. Intervention The intervention encompassed education, advice, mobility and core stability exercises, progressive exercise, and encouragement of early return to work/activity. Patients received ≤8 sessions for ≤8 weeks, starting 4 weeks post surgery (baseline). Outcomes Blinded outcome assessment at baseline and 12 weeks (post intervention) included the Roland Morris Disability Questionnaire. STarT Back data were collected at baseline. Statistical analyses summarised participant characteristics and preplanned descriptive analyses. Thematic analysis grouped related data. Findings Twenty-two of 29 allocated participants received the intervention. STarT Back categorised n=16 (55%) participants ‘not at low risk’. Physiotherapists identified reasons for caution for 8 (36%) participants, commonly risk of overdoing activity (n=4, 18%). There was no relationship between STarT Back and physiotherapists’ evaluation of caution. Physiotherapists identified 154 problems (mean (SD) 5.36 (2.63)). Those ‘not at low risk’, and/or requiring caution presented with more problems, and required more sessions (mean (SD) 3.14 (1.16)). Conclusions Patients present differently and therefore require tailored interventions. These

  13. 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

  14. 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

  15. 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.

  16. An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance.

    PubMed

    Langley, Richard G B; Luger, Thomas A; Cork, Michael J; Schneider, Dirk; Paul, Carle

    2007-01-01

    In this report, we review the data on the safety and tolerability of pimecrolimus cream 1% (Elidel) from clinical trials and post-marketing surveillance in patients with atopic dermatitis. These data demonstrate that topically applied pimecrolimus is minimally absorbed through the skin and has a favourable safety margin. The most common treatment-related adverse events are transient local reactions, particularly skin burning (16.1 and 12.9 events per 1,000 patient-months of follow-up in adults and children, respectively). When compared to the vehicle, the use of pimecrolimus cream 1% is associated with an increased incidence of herpes simplex virus infections in children (relative risk: 2.5; 95% confidence interval: 1.2-5.8; p = 0.017). However, pimecrolimus cream 1% does not increase the incidence of any skin infection in comparison with moderately potent topical corticosteroids and lacks other corticosteroid-related side effects such as skin atrophy. While cases of malignancy have been reported in patients who have used pimecrolimus cream 1%, there is no clinical evidence to establish that treatment with pimecrolimus cream 1% increases the risk of malignancy.

  17. 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.…

  18. Randomised controlled trial evaluation of Tweet2Quit: a social network quit-smoking intervention

    PubMed Central

    Pechmann, Cornelia; Delucchi, Kevin; Lakon, Cynthia M; Prochaska, Judith J

    2016-01-01

    Background We evaluated a novel Twitter-delivered intervention for smoking cessation, Tweet2Quit, which sends daily, automated communications to small, private, self-help groups to encourage high-quality, online, peer-to-peer discussions. Design A 2-group randomised controlled trial assessed the net benefit of adding a Tweet2Quit support group to a usual care control condition of nicotine patches and a cessation website. Participants Participants were 160 smokers (4 cohorts of 40/cohort), aged 18–59 years, who intended to quit smoking, used Facebook daily, texted weekly, and had mobile phones with unlimited texting. Intervention All participants received 56 days of nicotine patches, emails with links to the smokefree.gov cessation website, and instructions to set a quit date within 7 days. Additionally, Tweet2Quit participants were enrolled in 20-person, 100-day Twitter groups, and received daily discussion topics via Twitter, and daily engagement feedback via text. Measures The primary outcome was sustained abstinence at 7, 30 and 60 days post-quit date. Results Participants (mean age 35.7 years, 26.3% male, 31.2% college degree, 88.7% Caucasian) averaged 18.0 (SD=8.2) cigarettes per day and 16.8 (SD=9.8) years of smoking. Participants randomised to Tweet2Quit averaged 58.8 tweets/participant and the average tweeting duration was 47.4 days/participant. Tweet2Quit doubled sustained abstinence out to 60 days follow-up (40.0%, 26/65) versus control (20.0%, 14/70), OR=2.67, CI 1.19 to 5.99, p=0.017. Tweeting via phone predicted tweet volume, and tweet volume predicted sustained abstinence (p<0.001). The daily autocommunications caused tweeting spikes accounting for 24.0% of tweets. Conclusions Tweet2Quit was engaging and doubled sustained abstinence. Its low cost and scalability makes it viable as a global cessation treatment. Trial registration number NCT01602536. PMID:26928205

  19. 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

  20. 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.

  1. Protocol for a multicentre randomised feasibility trial evaluating early Surgery Alone In LOw Rectal cancer (SAILOR)

    PubMed Central

    Thorne, Kymberley; Hutchings, Hayley; Islam, Saiful; Holland, Gail; Hatcher, Olivia; Gwynne, Sarah; Jenkins, Ian; Coyne, Peter; Duff, Michael; Feldman, Melanie; Winter, Des C; Gollins, Simon; Quirke, Phil; West, Nick; Brown, Gina; Fitzsimmons, Deborah; Brown, Alan; Beynon, John

    2016-01-01

    Introduction There are 11 500 rectal cancers diagnosed annually in the UK. Although surgery remains the primary treatment, there is evidence that preoperative radiotherapy (RT) improves local recurrence rates. High-quality surgery in rectal cancer is equally important in minimising local recurrence. Advances in MRI-guided prediction of resection margin status and improvements in abdominoperineal excision of the rectum (APER) technique supports a reassessment of the contribution of preoperative RT. A more selective approach to RT may be appropriate given the associated toxicity. Methods and analysis This trial will explore the feasibility of a definitive trial evaluating the omission of RT in resectable low rectal cancer requiring APER. It will test the feasibility of randomising patients to (1) standard care (neoadjuvant long course RT±chemotherapy and APER, or (2) APER surgery alone for cT2/T3ab N0/1 low rectal cancer with clear predicted resection margins on MRI. RT schedule will be 45 Gy over 5 weeks as current standard, with restaging and surgery after 8–12 weeks. Recruitment will be for 24 months with a minimum 12-month follow-up. Objectives Objectives include testing the ability to recruit, consent and retain patients, to quantify the number of patients eligible for a definitive trial and to test feasibility of outcomes measures. These include locoregional recurrence rates, distance to circumferential resection margin, toxicity and surgical complications including perineal wound healing, quality of life and economic analysis. The quality of MRI staging, RT delivery and surgical specimen quality will be closely monitored. Ethics and dissemination The trial is approved by the Regional Ethics Committee and Health Research Authority (HRA) or equivalent. Written informed consent will be obtained. Serious adverse events will be reported to Swansea Trials Unit (STU), the ethics committee and trial sites. Trial results will be submitted for peer review

  2. 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

  3. Randomized phase II/III trial of post-operative chemoradiotherapy comparing 3-weekly cisplatin with weekly cisplatin in high-risk patients with squamous cell carcinoma of head and neck: Japan Clinical Oncology Group Study (JCOG1008).

    PubMed

    Kunieda, Futoshi; Kiyota, Naomi; Tahara, Makoto; Kodaira, Takeshi; Hayashi, Ryuichi; Ishikura, Satoshi; Mizusawa, Junki; Nakamura, Kenichi; Fukuda, Haruhiko; Fujii, Masato

    2014-08-01

    A randomized Phase II/III study was launched in Japan to evaluate the non-inferiority of concurrent chemoradiotherapy with weekly cisplatin (40 mg/m(2)) compared with concurrent chemoradiotherapy with 3-weekly cisplatin (100 mg/m(2)) for post-operative high-risk patients with locally advanced squamous cell carcinoma of head and neck. This study began in October 2012, and a total of 260 patients will be accrued from 18 institutions within 5 years. The primary endpoint of the Phase II part is proportion of treatment completion and that of the Phase III part is overall survival. The secondary endpoints are relapse-free survival, local relapse-free survival, nutrition-support-free survival, non-hospitalized treatment period during permissible treatment period and adverse events. This trial was registered at the UMIN Clinical Trials Registry as UMIN 000009125 [http://www.umin.ac.jp/ctr/].

  4. 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.

  5. 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

  6. Need for alternative trial designs and evaluation strategies for therapeutic studies of invasive mycoses.

    PubMed

    Rex, J H; Walsh, T J; Nettleman, M; Anaissie, E J; Bennett, J E; Bow, E J; Carillo-Munoz, A J; Chavanet, P; Cloud, G A; Denning, D W; de Pauw, B E; Edwards Jr, J E; Hiemenz, J W; Kauffman, C A; Lopez-Berestein, G; Martino, P; Sobel, J D; Stevens, D A; Sylvester, R; Tollemar, J; Viscoli, C; Viviani, M A; Wu, T

    2001-07-01

    Studies of invasive fungal infections have been and remain difficult to implement. Randomized clinical trials of fungal infections are especially slow and expensive to perform because it is difficult to identify eligible patients in a timely fashion, to prove the presence of the fungal infection in an unequivocal fashion, and to evaluate outcome in a convincing fashion. Because of these challenges, licensing decisions for antifungal agents have to date depended heavily on historical control comparisons and secondary advantages of the new agent. Although the availability of newer and potentially more effective agents makes these approaches less desirable, the fundamental difficulties of trials of invasive fungal infections have not changed. Therefore, there is a need for alternative trial designs and evaluation strategies for therapeutic studies of invasive mycoses, and this article summarizes the possible strategies in this area.

  7. Towards a Trial Plan for Evaluating the COMDAT TD

    DTIC Science & Technology

    2004-03-31

    PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Defence R&D Canada -Ottawa,3701 Carling...Ave,Ottawa Ontario,CA,K1A 0Z4 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S...to evaluate its potential impact upon operator performance in the Operations Room of the Halifax Class frigate. Specific issues commented upon

  8. 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

  9. Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial

    PubMed Central

    Chapman, Kimberley N.; Pevzner, Eric; Mangan, Joan M.; Breese, Peter; Lamunu, Dorcas; Shrestha-Kuwahara, Robin; Nakibali, Joseph G.; Goldberg, Stefan V.

    2016-01-01

    Background Ethical principles obligate researchers to maximize study participants’ comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. Methods Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. Results ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24–42). Median ICAT scores were 80% (IQR: 67–93) for comprehension and 89% (IQR: 78–100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. Conclusions Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities

  10. New clinical research strategies in thoracic oncology: clinical trial design, adaptive, basket and umbrella trials, new end-points and new evaluations of response.

    PubMed

    Menis, Jessica; Hasan, Baktiar; Besse, Benjamin

    2014-09-01

    In the genomics era, our main goal should be to identify large and meaningful differences in small, molecularly selected groups of patients. Classical phase I, II and III models for drug development require large resources, limiting the number of experimental agents that can be tested and making the evaluation of targeted agents inefficient. There is an urgent need to streamline the development of new compounds, with the aim of identifying "trials designed to learn", which could lead to subsequent "trials designed to conclude". Basket trials are often viewed as parallel phase II trials within the same entity, designed on the basis of a common denominator, which can be a molecular alteration(s). Most basket trials are histology-independent and aberration-specific clinical trials. Umbrella trials are built on a centrally performed molecular portrait and molecularly selected cohorts with matched drugs, and can include patients' randomisation and strategy validation. Beyond new designs, new end-points and new evaluation techniques are also warranted to finally achieve methodology and clinical improvements, in particular within immunotherapy trials.

  11. Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

    DTIC Science & Technology

    2012-02-01

    proposal addresses this important gap and aims to evaluate an innovative suicide intervention , Post Admission Cognitive Therapy (PACT). Left...cognitive behavioral intervention program, titled, Post Admission Cognitive Therapy (PACT), for military service members and beneficiaries admitted...listening to digital recordings of therapy sessions and/or reviewing of typed transcribed sessions for the purposes of treatment refinement and integrity

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

    PubMed

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

    2013-07-07

    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.

  13. 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.

  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. 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…

  16. 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…

  17. 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…

  18. 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).…

  19. A Systematic Review of Controlled Trials Evaluating Interventions in Adult Literacy and Numeracy

    ERIC Educational Resources Information Center

    Torgerson, Carole; Porthouse, Jill; Brooks, Greg

    2005-01-01

    This paper reports a systematic review of the quasi-experimental literature in the field of adult literacy and numeracy, published between 1980 and 2002. We included 27 controlled trials (CTs) that evaluated strategies and pedagogies designed to increase adult literacy and numeracy: 18 CTs with no effect sizes (incomplete data) and 9 CTs with full…

  20. Effects of one session radial extracorporeal shockwave therapy on post-stroke plantarflexor spasticity: a single-blind clinical trial.

    PubMed

    Radinmehr, Hojjat; Nakhostin Ansari, Noureddin; Naghdi, Soofia; Olyaei, Gholamreza; Tabatabaei, Azadeh

    2017-03-01

    Purpose To examine the effects of radial extracorporeal shockwave therapy (rESWT) on plantarflexor spasticity after stroke. Method Twelve patients with stroke were randomly included for this prospective, single-blind clinical trial. Patients received one rESWT session (0.340 mJ/mm(2), 2000 shots) on plantarflexor muscle. The Modified Modified Ashworth Scale (MMAS), H-reflex tests, ankle range of motion (ROM), passive plantarflexor torque (PPFT) and timed up and go test (TUG) were measured at baseline (T0), immediately after treatment (T1) and one hour after the end of the treatment (T2). Results Patients had improved the MMAS scores for both the gastrocnemius and the soleus muscles, active and passive ROM, PPFT and TUG over time after rESWT. For the PPFT, it was greater at high velocity than at low velocity, and there was a significant three-way interaction between time, knee position (extended/flexed) and velocity (low/high). The H-reflex latency had decreased at T1, but there was no significant effect on Hmax/Mmax ratio. Conclusions The rESWT improved plantarflexor spasticity, and the effects sustained for one hour, whereas it was not effective in improving spinal excitability. Implications for Rehabilitation One session radial extracorporeal shock wave therapy (rESWT) is safe and effective in improving post stroke plantarflexor spasticity, ankle active and passive range of motion, passive torque, and walking capability. The spasticity scores improved for both the gastrocnemius and the soleus muscles and persisted one hour after rESWT. The magnitude of resistive plantarflexor passive torque in the knee extended position and high velocity was larger over time suggesting greater gastrocnemius spasticity than soleus. The rESWT had no significant effects on alpha motorneuron excitability.

  1. Evaluation of a Clinical Cancer Trial Research Training Workshop: Helping Nurses Build Capacity in Southwest Virginia.

    PubMed

    Burnett, Camille; Bullock, Linda; Collins, Cathleen A; Hauser, Lindsay

    2016-11-01

    Residents of Southwest Virginia (SWVA) face significant barriers in accessing the most advanced forms of cancer care, cancer risk reduction, and clinical trials involvement. A collaboration between the University of Virginia (UVA) Cancer Center and UVA School of Nursing was forged with oncology caregivers in this region to build community capacity to support Cancer Clinical trials (CCT) by strengthening the workforce, and thus improving health outcomes for this underserved region of Appalachia. The UVA School of Nursing designed an educational workshop focusing on the basics of CCT to facilitate the development of a skilled nursing workforce in the SWVA region that could provide care to patients on protocol and/or to encourage residents to participate in trials. The goal of the workshop was to offer a CCT training session for oncology nurses that fostered the knowledge and skills necessary to facilitate and support CCT infrastructure across this high-risk region. This evaluation reports the learning outcomes of the CCT training on 32 nurse participants from SWVA. Evaluations of the training program showed high rates of satisfaction, increased comfort level with CCTs, and increased knowledge and attitude toward CCTs. These findings provide information about a curriculum that could be useful in educating other oncology nurses and student nurses how to care for patients who may be enrolled in a clinical trial. Nurses can also be advocates for participation in clinical trials once they have the knowledge and are comfortable in their own understanding of a trial's usefulness. Educating the nursing workforce is an essential component of building capacity and infrastructure to support clinical trials research.

  2. A Randomized Controlled Dismantling Trial of Post-Workshop Consultation Strategies to Increase Effectiveness and Fidelity to an Evidence-Based Psychotherapy for Posttraumatic Stress Disorder

    DTIC Science & Technology

    2013-08-01

    be assessed by trained graduate students and post-doctoral fidelity assessors. Consistent with recommended clinical practice and research trials...measure of clinician attitudes toward EBPs, consisting of 12 factors, with moderate to large factor loadings and fair to excellent internal consistency...methods (i.e., positive deviance ; [65]) that the clinicians deemed helpful in acquiring and maintaining CPT skills. We based our interview questions

  3. Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

    DTIC Science & Technology

    2013-02-01

    depression, trauma, sleep , suicide ideation), repeat number of psychiatric hospitalization(s), hope for one’s future, and acceptability of treatment (as...0106 TITLE: Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi- Site...Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial Service Members and Veterans 5a

  4. ICF Based Comprehensive Evaluation for Post-Acute Spinal Cord Injury

    PubMed Central

    Nam, Hyung Seok; Kim, Kwang Dong

    2012-01-01

    Objective To evaluate the feasibility of the ICF for initial comprehensive evaluation of early post-acute spinal cord injury. Method A comprehensive evaluation of 62 early post-acute spinal cord injury (SCI) patients was conducted by rehabilitation team members, such as physicians, physical therapists, occupational therapists, nutritionists, medical social-workers, and nurses. They recorded each of their evaluation according to the ICF first level classification. The contents of the comprehensive evaluation were linked to the ICF second level categories, retrospectively. The linked codes were analyzed descriptively and were also compared with the brief ICF core set for early post-acute SCI. Results In the evaluation of early post-acute SCI patients based on the ICF first level categories, 19 items from the body functions domain, such as muscle power functions (b730) and urination functions (b620), 15 items from the body structures domain, including spinal cord and related structures (s120), 11 items from the activities and participation domain, such as transferring oneself (d420) and walking (d450), and 9 items from the environmental factors domain, e.g., health professionals (e355), were linked to the ICF second level categories. In total, 82.4% of all contents were linked to the brief ICF core set. Prognosis insight, a personal factor not linkable to an ICF code, was mentioned in 29.0% of all patients. Conclusion First level ICF categories can provide a structural base for a comprehensive evaluation in early post-acute spinal cord injury. However, frequently linked items, including the brief core set, as well as personal factors should be considered via a checklist in order to prevent the omission of significant contents. PMID:23342313

  5. Evaluation of four cementation strategies on the push-out bond strength between fiber post and root dentin.

    PubMed

    Bergoli, Cesar Dalmolin; Amaral, Marina; Druck, Carolina Ceolin; Valandro, Luiz Felipe

    2011-01-01

    This trial used push-out testing to evaluate four different fiber post cementation strategies. Specimens of bovine mandibular teeth were randomly allocated into four groups according to cementation strategies (n = 10): ScotchBond MultiPurpose and RelyX ARC (Group 1); AdheSE and Multilink Automix (Group 2); phosphoric acid and RelyX U100 (Group 3); and RelyX U100 (Group 4). Four slices from each specimen (2.0 mm thick) were obtained for the push-out test. All slices were analyzed for failure mode after testing. A one-way ANOVA showed differences between the groups (P = 0.002). A Tukey test indicated that Group 1 had the highest bond strength values (13.96 ± 6.41 MPa). Groups 2 (6.58 ± 2.14 MPa), 3 (5.85 ± 2.57 MPa), and 4 (8.19 ± 2.28 MPa) had similar bond strengths, but all of them were lower than Group 1. A three-step total etching adhesive system, associated with a conventional resin cement, might be a good alternative for fiber post cementation.

  6. 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

  7. Effects of Cinacalcet on Atherosclerotic and Nonatherosclerotic Cardiovascular Events in Patients Receiving Hemodialysis: The EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial

    PubMed Central

    Wheeler, David C.; London, Gerard M.; Parfrey, Patrick S.; Block, Geoffrey A.; Correa‐Rotter, Ricardo; Dehmel, Bastian; Drüeke, Tilman B.; Floege, Jürgen; Kubo, Yumi; Mahaffey, Kenneth W.; Goodman, William G.; Moe, Sharon M.; Trotman, Marie‐Louise; Abdalla, Safa; Chertow, Glenn M.; Herzog, Charles A.

    2014-01-01

    Background Premature cardiovascular disease limits the duration and quality of life on long‐term hemodialysis. The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms, risk factors for these events, and the effects of cinacalcet, using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial. Methods and Results EVOLVE was a randomized, double‐blind, placebo‐controlled clinical trial that randomized 3883 hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to 64 months. For this post hoc analysis, the outcome measure was fatal and nonfatal cardiovascular events reflecting atherosclerotic and nonatherosclerotic cardiovascular diseases. During the trial, 1518 patients experienced an adjudicated cardiovascular event, including 958 attributable to nonatherosclerotic disease. Of 1421 deaths during the trial, 768 (54%) were due to cardiovascular disease. Sudden death was the most frequent fatal cardiovascular event, accounting for 24.5% of overall mortality. Combining fatal and nonfatal cardiovascular events, randomization to cinacalcet reduced the rates of sudden death and heart failure. Patients randomized to cinacalcet experienced fewer nonatherosclerotic cardiovascular events (adjusted relative hazard 0.84, 95% CI 0.74 to 0.96), while the effect of cinacalcet on atherosclerotic events did not reach statistical significance. Conclusions Accepting the limitations of post hoc analysis, any benefits of cinacalcet on cardiovascular disease in the context of hemodialysis may result from attenuation of nonatherosclerotic processes. Clinical Trials Registration Unique identifier: NCT00345839. URL: ClinicalTrials.gov. PMID:25404192

  8. 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.

  9. 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

  10. [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.

  11. 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…

  12. 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…

  13. 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

  14. To evaluate and compare the effect of different Post Surface treatments on the Tensile Bond Strength between Fiber Posts and Composite Resin.

    PubMed Central

    Shori, Deepa; Pandey, Swapnil; Kubde, Rajesh; Rathod, Yogesh; Atara, Rahul; Rathi, Shravan

    2013-01-01

    Background: Fiber posts are widely used for restoration of mutilated teeth that lack adequate coronal tooth structure to retain a core for definitive restoration, bond between the fiber post and composite material depends upon the chemical reaction between the post surface and the resin material used for building up the core. In attempt to maximize the resin bonding with fiber post, different post surface conditioning is advocated. Therefore the purpose of the study is to examine the interfacial strength between fiber post and composite, as core build-up material after different surface treatments of fiber posts. Materials & Methods:Twenty fiber posts were split into four groups off five each according to different surface treatments viz. Group I-(Negative Control), Group II-Silanization (Positive control), Group III-(37% Phosphoric Acid & Silanization) ,Group IV- (10% Hydrogen Peroxide and Silanization). With the preformed plastic mould, a core of dual cure composite resin around the fiber post having the uniform thickness was created. Tensile bond strength of each specimen was measured under Universal Testing Machine (UTM) at the cross head speed of 3mm/min. Results: The results achieved with 10% Hydrogen peroxide had a marked effect on micro tensile bond strength values between the tested materials. Conclusion: Immense enhancement in the silanization efficiency of quartz fiber phase was observed with different surface chemical treatment of the resin phase of fiber posts with the marked increase in the micro-tensile bond strength between fiber post and composite core. How to cite this article: Shori D, Pandey S, Kubde R, Rathod Y, Atara R, Rathi S. To evaluate and compare the effect of different Post Surface treatments on the Tensile Bond Strength between Fiber Posts and Composite Resin. J Int Oral Health 2013; 5(5):27-32. PMID:24324301

  15. Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols

    PubMed Central

    Kyte, Derek; Duffy, Helen; Fletcher, Benjamin; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; King, Madeleine; Draper, Heather; Ives, Jonathan; Brundage, Michael; Blazeby, Jane; Calvert, Melanie

    2014-01-01

    Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully

  16. The Sandia/Arzamas-16 Magazine-to-Magazine Remote Monitoring Field Trial Evaluation

    SciTech Connect

    Barkanov, Boris; Blagin, Sergei; Croessmann, Dennis; Damico, Joe; Ehle, Steve; Nilsen, Curt

    1999-07-12

    Sandia National Laboratories and the Russian Federal Nuclear Center-All Russian Research Institute for Experimental Physics (VNIIEF) (also known as Arzamas-16) are collaborating on ways to assure the highest standards of safety, security, and international accountability of fissile material. For these collaborations, sensors and information technologies have been identified as important in reaching these standards in a cost-effective manner. Specifically, Sandia and VNIIEF have established a series of remote monitoring field trials to provide a mechanism for joint research and development on storage monitoring systems. These efforts consist of the ''Container-to-Container'', ''Magazine-to-Magazine'', and ''Facility-to-Facility'' field trials. This paper will describe the evaluation exercise Sandia and VNIIEF conducted on the Magazine-to-Magazine systems. Topics covered will include a description of the evaluation philosophy, how the various sensors and system features were tested, evaluation results, and lessons learned.

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

    PubMed

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

    2015-10-01

    Institutional review boards, which are charged with overseeing research, must classify the riskiness of proposed research according to a federal regulation known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration codified in 21 CFR 50. If an institutional review board determines that a clinical trial constitutes "minimal risk," there are important practical implications: the institutional review board may then allow a 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 institutional review boards using an expedited process. However, it is unclear how institutional review boards should assess the risk levels of pragmatic clinical trials. 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 article, we examine the common interpretations of research regulations regarding minimal-risk classifications and suggest that they 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 pragmatic clinical trial. We then examine two pragmatic clinical trials and consider how various factors including clinical equipoise, practice variation, research methods such as cluster randomization, and patients' perspectives may contribute to current and evolving concepts of minimal-risk determinations, and how this understanding in turn affects the design and conduct of pragmatic clinical trials.

  18. 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

  19. Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. Methods/Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. Discussion This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. Trial registration Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066 PMID:24135085

  20. 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

  1. 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

  2. Use of range vernier data in missile post-flight accuracy evaluation

    NASA Astrophysics Data System (ADS)

    Shipplett, C. M.

    Rockwell conducts accuracy evaluations for the Ogden Air Logistics Center for selected Minuteman Operational Test flights. As a part of these evaluations, regression analysis are performed with guidance-minus-radar slant range comparisons as observables. Typically there are six or seven radars tracking the post-boost vehicle which carries a coherent C-band transponder. Several of these radars also provide range rate data. For a recent Minuteman III test flight, an experimental range vernier tape generated by Federal Electric Corporation was supplied to Rockwell. This tape contained data from one site only, and was used in conjunction with the standard assortment of radar tapes in the post-flight evaluation. This paper describes and shows examples of the effects of using range vernier data.

  3. Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Abstract Background Approximately 80,000 patients each year are admitted to UK hospitals with an acute stroke and are immobile. At least 10% will develop a proximal Deep Vein Thrombosis in the first month and 1.5% a pulmonary embolus. Although hydration, antiplatelet treatment and early mobilisation may reduce the risk of deep vein thrombosis, there are currently no preventive strategies which have been clearly shown to be both effective and safe. Anticoagulation increases the risks of bleeding and compression stockings are ineffective. Systematic reviews of small randomized trials of intermittent pneumatic compression have shown that this reduces the risk of deep vein thrombosis in patients undergoing surgery, but that there are few data concerning its use after stroke. The CLOTS trial 3 aims to determine whether, compared with best medical care, best medical care plus intermittent pneumatic compression in immobile stroke patients reduces the risk of proximal deep vein thrombosis. Methods/Design CLOTS Trial 3 is a parallel group multicentre trial; with centralized randomisation (minimisation) to ensure allocation concealment. Over 80 centres in the UK will recruit 2800 immobile stroke patients within the first 3 days of their hospital admission. Patients will be allocated to best medical care or best medical care plus intermittent pneumatic compression. Ultrasonographers will perform a Compression Duplex Ultrasound Scan to detect deep vein thrombosis in each treatment group at about 7-10 days and 25-30 days. The primary outcome cluster includes symptomatic or asymptomatic deep vein thrombosis in the popliteal or femoral veins detected on either scan. Patients are then followed up by postal or telephone questionnaire at 6 months from randomisation to detect later symptomatic deep vein thrombosis and pulmonary emboli and to establish their functional outcome (Oxford handicap scale) and quality of life (EQ5D-3 L). The ultrasonographers performing the scans are

  4. Safety and efficacy of tiotropium Respimat versus HandiHaler in patients naive to treatment with inhaled anticholinergics: a post hoc analysis of the TIOSPIR trial

    PubMed Central

    Wise, Robert; Calverley, Peter MA; Dahl, Ronald; Dusser, Daniel; Metzdorf, Norbert; Müller, Achim; Fowler, Andy; Anzueto, Antonio

    2015-01-01

    Background: Patients with chronic obstructive pulmonary disease (COPD) who were naive to anticholinergics before the TIOtropium Safety and Performance In Respimat (TIOSPIR) trial may reflect patients seen in practice, in particular in primary care. In addition, investigating safety in these patients avoids the potential bias in patients who previously received anticholinergics and may be tolerant of their effects. Aims: The aim of this study was to evaluate whether patients naive to anticholinergic therapy who were treated with tiotropium Respimat 2.5 or 5 μg had different safety and efficacy outcomes than patients treated with tiotropium HandiHaler 18 μg. Methods: A post hoc analysis of patients who were not receiving anticholinergics before TIOSPIR (N=6,966/17,135) was conducted. Primary end points were risk of death from any cause and risk of COPD exacerbation. Secondary outcomes included severe exacerbation and major adverse cardiovascular events (MACE). Additional analysis of exacerbations was carried out in anticholinergic-naive patients with moderate (GOLD II) disease. Results: Anticholinergic-naive patients had less severe disease than the total TIOSPIR population. Discontinuations because of anticholinergic side effects were infrequent (0.9% overall). Similar to the primary study, patients in the tiotropium Respimat groups had no difference in the risk of death or risk of any or severe exacerbation than patients treated with tiotropium HandiHaler. Risk of MACE was similar across the Respimat and HandiHaler groups. Rates of exacerbations in the subgroup of patients with moderate disease were similar across the Respimat and HandiHaler groups. Conclusions: Tiotropium Respimat and HandiHaler have similar safety and efficacy profiles in patients who are naive to anticholinergic therapy. PMID:26540491

  5. 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

  6. Evaluation Studies of The Nuffield A-Level Biology Trials--2. Evaluation of Specific Objectives

    ERIC Educational Resources Information Center

    Kelly, P. J.

    1972-01-01

    Reports the results of evaluation of specified student and course objectives by teacher ratings and test results. Includes a discussion of the evaluation of the materials as a result of formative evaluation. (AL)

  7. A systematic review evaluating the impact of post-registration nursing and midwifery education on practice.

    PubMed

    Gijbels, Harry; O'Connell, Rhona; Dalton-O'Connor, Caroline; O'Donovan, Moira

    2010-03-01

    Given the current focus on evidence-based practice, it is surprising that there is a dearth of systematic evidence of the impact on practice of post-registration nursing and midwifery education. The systematic review presented here formed part of a national review of post-registration nursing and midwifery education in Ireland [Health Service Executive, 2008. Report of the Post-registration Nursing and Midwifery Education Review Group: Changing practice to support service delivery. Health Service Executive, Dublin]. The review focuses specifically on the impact on practice from the perspective of nurses, midwives, patients, carers, education and health service providers. Sixty-one (61) studies met the criteria set. These studies were mainly of a retrospective and descriptive nature, often with small cohorts, set within one educational setting. The findings indicate that students benefit from post-registration programmes in relation to changes in attitudes, perceptions, knowledge and in skill acquisition. There is also some evidence that students apply their newly acquired attitudes, knowledge and skills. There is however limited evidence of the direct impact on organisational and service delivery changes, and on benefits to patients and carers. It can be concluded that the impact of post-registration nursing and midwifery education on practice has yet to be fully explored through a more systematic and coherent programme evaluation approach.

  8. The Development and Field Trial of a System for Evaluating the Effectiveness and Efficiency of a Training Program

    DTIC Science & Technology

    1982-03-01

    Research Report 1336 THE DEVELOPMENT AND FIELD TRIAL OF A SYSTEM FOR EVALUATING THE EFFECTIVENESS AND EFFICIENCY OF A TRAINING PROGRAM Rol G w d Don...FIELD TRIAL OF A SYSTEM FOR EVALUATING THE EFFECTIVENESS AND EFFICIENCY Final Report OF A TRAINING PROGRAM 6. PERFORMING ORG. REPORT NUMBER 7...Training Evaluation Methodology Training Program Deficiencies 2&. AStUAC ( CantOe mirevee ol it nocooay and identify by block number) 7A unique system

  9. 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

  10. 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

  11. 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

  12. 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.

  13. Soluble TNF-related apoptosis induced ligand (sTRAIL) is augmented by Post-Conditioning and correlates to infarct size and left ventricle dysfunction in STEMI patients: a substudy from a randomized clinical trial.

    PubMed

    Luz, André; Santos, Mário; Magalhães, Rui; Oliveira, José Carlos; Pacheco, Ana; Silveira, João; Cabral, Sofia; Torres, Severo; Leite-Moreira, Adelino F; Carvalho, Henrique

    2017-02-01

    Low levels of Soluble TNF-related apoptosis induced ligand (sTRAIL) seem to be related to worse prognosis after an acute coronary syndrome. PostConditioning (PostCond) may protect the heart from reperfusion injury. We sought to evaluate the impact of PostCond on sTRAIL in relationship to infarct size (area under the curve of Troponin T, AUCTnT) and left ventricle ejection fraction (LVEF) in a series of patients undergoing primary coronary intervention for ST-segment elevation myocardial infarction (STEMI). In a substudy of a randomized trial that tested the effects of PostCond in STEMI-patients, sTRAIL was measured 24 h after reperfusion (PostCond n = 39, Control n = 39). Correlations between sTRAIL and both AUCTnT and LVEF were studied for each study arm. At 24 h, sTRAIL was higher for PostCond vs Controls (46.4 ± 30.6 vs 32.9 ± 23.4, p = 0.031), was negatively related to AUCTnT [B = -0.09, 95 % CI (-0.15 to -0.30), p = 0.005] and was positively related to both in-hospital [B = 0.10, 95 % CI (0.02-0.17), p = 0.018], and follow-up LVEF [B = 0.21, 95 % (0.10-0.32), p = 0.001]. No significant relationship was found for Controls. On multivariate analysis, PostCond was an independent predictor for sTRAIL [B = 12.13 95 % CI (0.40-23.87), p = 0.043]. In conclusion, PostCond positively influenced sTRAIL, which was related to reduced infarct size and better LVEF. Further studies are needed to understand potential mechanisms elicited by PostCond in infarct size reduction.

  14. 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.

  15. [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.

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

    DTIC Science & Technology

    2010-12-10

    challenges and respond timely to the many headquarters and field support requests. The Navy and Marine Corps continue struggling to overcome technology and...committee recognizes that a series of Navy Judge Advocates General have attempted to overcome the systemic challenges associated with preparing...professional shortcoming is more widely resented than procrastination . A client’s interests often can be adversely affected by the passage of time or

  17. 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

  18. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD

    PubMed Central

    Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

    2016-01-01

    Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design. PMID:27932872

  19. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD.

    PubMed

    Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

    2016-01-01

    Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design.

  20. 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

  1. 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…

  2. 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

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

    NASA Astrophysics Data System (ADS)

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

    2010-05-01

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

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

    SciTech Connect

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

    2010-05-31

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

  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. 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

  7. 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

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

    PubMed Central

    Reza, Fazal; Ibrahim, Nur Sukainah

    2015-01-01

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

  9. A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

    PubMed Central

    2011-01-01

    Background Many newly screened people living with HIV (PLHIV) in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV) care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400) from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills), the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up) pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1). No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by community support

  10. [Thought on several problems of post-marketing herbs clinical evaluation in special populations].

    PubMed

    Zhou, Ai; Lian, Fengmei

    2011-10-01

    The re-evaluation of clinical post-marketing herbs in special populations, such as children, the aged, pregnant women, lactating women, has attracted attention in our country. The media is drug adverse reaction reports and package insert. The safety of combined administration in aged and children's growth should have been taken long-term follow-up study. Perfecting traditional chinese medicine FDA system will be beneficial to the re-evaluation of clinical postmarketing herbs in pregnant women. Dose-effect study in children also should cause the concern of researchers.

  11. 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

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

    NASA Astrophysics Data System (ADS)

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

    2015-10-01

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

  13. Assessing clinical trials of Internet addiction treatment: a systematic review and CONSORT evaluation.

    PubMed

    King, Daniel L; Delfabbro, Paul H; Griffiths, Mark D; Gradisar, Michael

    2011-11-01

    Although there is ongoing debate concerning the clinical status of Internet addiction, and the quality of the extant literature in this emerging field is not optimal, several clinical trials of both pharmacological and psychological treatments for Internet addiction have been published in recent years. A systematic review investigating the reporting quality of eight treatment studies is presented. Reporting quality was defined according to the 2010 Consolidating Standards of Reporting Trials (CONSORT) statement. An evaluation of the reviewed studies highlighted several key limitations, including (a) inconsistencies in the definition and diagnosis of Internet addiction, (b) a lack of randomization and blinding techniques, (c) a lack of adequate controls or other comparison groups, and (d) insufficient information concerning recruitment dates, sample characteristics, and treatment effect sizes. It is concluded that improvements in future studies' design and reporting would be of significant benefit to both researchers and clinicians, and to the overall positioning of Internet addiction in the behavioral addiction field.

  14. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery

    PubMed Central

    2010-01-01

    Background A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery. Methods Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study. Results The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event. Conclusion This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery. Trial Registration ClinicalTrials.gov NCT01244165 PMID:21144043

  15. A randomised controlled trial of nurse-managed trial conclusion following early phase cancer trial participation.

    PubMed

    Cox, K; Wilson, E; Arthur, A; Elkan, R; Armstrong, S

    2005-07-11

    The effect of a nurse-managed intervention, for early phase cancer trial participants at trial conclusion, on psychosocial outcomes was evaluated at two cancer centres in the Midlands, England using a randomised controlled trial. It involved 117 patients who were participating in an early phase cancer clinical trial. It was a nurse-managed trial exit, which included a trial exit interview, trial feedback information leaflet and telephone follow-up compared with standard care at trial conclusion. Psychological distress at 1 week and 4-6 weeks post-trial conclusion, patient's knowledge and understanding and patient's satisfaction were assessed. The results showed there was no significant difference between the two groups regarding scores for anxiety and depression at time one and time two. There is some suggestion that the intervention reduced anxiety from trial conclusion to follow-up (P=0.27). Patients in both groups felt they had contributed to cancer research through trial participation. However, intervention patients were more likely to feel that they knew how the trial was going (P<0.001), knew how other people in the trial were doing (P=0.001), had all the feedback they needed about the trial they took part in (P<0.01) and knew how they would be followed up (P=0.02). Patient satisfaction with the intervention was high (median score=4.5 where 5 is greatest satisfaction). In conclusion, nurse-managed trial conclusion led to positive outcomes for patients who had recently completed a clinical trial.

  16. Evaluation of the post-rotational nystagmus test (PRN) in determining alcohol intoxication.

    PubMed

    Karlovsek, Majda Z; Balazic, Joze

    2005-01-01

    This study evaluated the accuracy of the post-rotational nystagmus test (PRN) on the basis of the results of 1006 PRN tests performed at the Institute for Forensic Medicine in Ljubljana between 1998 and 2002 during standardized medical examinations in cases of suspected drunk driving. The evaluation of PRN test results with blood alcohol concentration (BAC) as a reference was based on classification into the following categories and characteristics: true positives (TP), true negatives (TN), false positives (FP), false negatives (FN), sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV), and accuracy. An optimal cut-off value of 10 s for post-rotational nystagmus time was chosen with the help of a receiver operating characteristic (ROC) curve for the BAC limit of 0.5 g/kg. The results of the decision analyses were: TP = 584, FP = 43, FN = 229, TN = 150, sensitivity = 0.718, specificity = 0.777, PPV= 0.931, NPV= 0.396, and accuracy = 0.730. The area under the ROC curve (AUC) was 0.813. Based on the AUC, the post-rotational nystagmus test is a good test for predicting alcohol intoxication over 0.5 g/kg. As a part of the physician's examination, it contributes significantly to the description of the clinical state.

  17. A randomised clinical trial evaluating the efficacy of physiotherapy after rotator cuff repair.

    PubMed

    Hayes, Kimberley; Ginn, Karen A; Walton, Judie R; Szomor, Zoltan L; Murrell, George A C

    2004-01-01

    The optimal form of rehabilitation after rotator cuff repair has yet to be determined. A randomised clinical trial was undertaken to compare outcomes for two forms of rehabilitation for this condition: individualised supervised physiotherapy treatment, and a standardised unsupervised home exercise regime. Fifty-eight volunteers with all sizes of operatively repaired rotator cuff tears were allocated randomly to one of the two treatment groups. All subjects received a standardised home exercise regime. Subjects who were randomised to the physiotherapy group received additional individualised treatment. Independent, blinded assessments of range of motion, muscle force and functional outcome measures were performed pre-operatively, and at six, 12 and 24 weeks postoperation. At six, 12 and 24 weeks post-operation, comparable outcomes were demonstrated for both rehabilitation groups. By 24 weeks post-operation, most subjects demonstrated outcomes that were consistent with a favourable recovery, regardless of rehabilitation mode. On the basis of these results, outcomes for subjects allocated to individualised physiotherapy treatment after rotator cuff repair are no better than for subjects allocated to a standardised home exercise regime.

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

    PubMed

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

    2015-09-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2015-03-01

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

  1. Design of Phase II cancer trials for evaluation of cytostatic/cytotoxic agents.

    PubMed

    Kocherginsky, Masha; Cohen, Ezra E W; Karrison, Theodore

    2009-01-01

    For experimental anticancer agents that may have both cytostatic and cytotoxic effects, assessment of response rates alone may not capture the full impact of the treatment. Oncologists are therefore interested in assessing both response and stable disease rates in early phase clinical trials of such therapies. We describe the design of a single-arm, Phase II clinical trial for the simultaneous evaluation of objective response and stable disease (lack of early tumor progression) rates using standard RECIST criteria. Demonstration of a sufficiently high rate for either of these endpoints will lead to rejection of the null hypothesis and a conclusion that the treatment warrants further study. A design is chosen that satisfies the desired type I error constraint and has sufficient statistical power at several selected points within the alternative hypothesis space using a restricted search algorithm. An early stopping rule for lack of efficacy is incorporated. The method is illustrated by the design of a Phase II clinical trial in head and neck cancer.

  2. Evaluating a Novel Summary Visualization for Clinical Trial Reports: A Usability Study

    PubMed Central

    Tong, Maurine; Hsu, William; Taira, Ricky K.

    2016-01-01

    Contributions of clinical trials are captured in published reports that are unstructured and often require extensive manual review to gain a deeper understanding of the study itself. Our goal is to increase comprehension and decrease the time necessary to understand these reports through the use of visualization tools. In this paper, we specify and evaluate the visualization of a previously developed representation as well as gain insight from user input for further development. The usability experiment consisted of a two-arm study with users either having or not having access to the visualization. A user questionnaire was used to measure time spent and accuracy in comprehension; intuitiveness and reproducibility of the visualization; and preferences. We found that having the visualization required on average 28.1% less time (25.8 min vs. 35.8 min, p=0.01) while maintaining similar accuracy (73.7% vs. 67.0%). Users were then asked to create their own visualizations, with their visualizations averaging 86.1% similar to the gold standard. All participants either preferred the visualization over the status quo or preferred both equally. These results demonstrate that novel visualizations for trial reports could provide time savings and achieve similar accuracy as reviewing the paper itself. Understanding the strength and quality of clinical trials can be alleviated with a visualization that makes content explicit. PMID:28269960

  3. Post-trial anatomical frame alignment procedure for comparison of 3D joint angle measurement from magnetic/inertial measurement units and camera-based systems.

    PubMed

    Li, Qingguo; Zhang, Jun-Tian

    2014-11-01

    Magnetic and inertial measurement units (MIMUs) have been widely used as an alternative to traditional camera-based motion capture systems for 3D joint kinematics measurement. Since these sensors do not directly measure position, a pre-trial anatomical calibration, either with the assistance of a special protocol/apparatus or with another motion capture system is required to establish the transformation matrices between the local sensor frame and the anatomical frame (AF) of each body segment on which the sensors are attached. Because the axes of AFs are often used as the rotational axes in the joint angle calculation, any difference in the AF determination will cause discrepancies in the calculated joint angles. Therefore, a direct comparison of joint angles between MIMU systems and camera-based systems is less meaningful because the calculated joint angles contain a systemic error due to the differences in the AF determination. To solve this problem a new post-trial AF alignment procedure is proposed. By correcting the AF misalignments, the joint angle differences caused by the difference in AF determination are eliminated and the remaining discrepancies are mainly from the measurement accuracy of the systems themselves. Lower limb joint angles from 30 walking trials were used to validate the effectiveness of the proposed AF alignment procedure. This technique could serve as a new means for calibrating magnetic/inertial sensor-based motion capture systems and correcting for AF misalignment in scenarios where joint angles are compared directly.

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

    PubMed Central

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

    2014-01-01

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

  5. Evaluation of Leber's hereditary optic neuropathy patients prior to a gene therapy clinical trial

    PubMed Central

    Yang, Shuo; Yang, Hong; Ma, Si-qi; Wang, Shuai-shuai; He, Heng; Zhao, Min-jian; Li, Bin

    2016-01-01

    Abstract Gene therapy may be a promising approach for the treatment of Leber hereditary optic neuropathy. The aim of this study was to evaluate patients with this condition who were recruited into an upcoming gene therapy clinical trial and to assess any changes in the detection parameters to provide support for the clinical trial. Sixteen patients with Leber hereditary optic neuropathy were evaluated using visual function tests 12 months before the initiation of gene therapy. Then, the results of visual acuity (VA), visual field (VF), RNFL (retinal nerve fiber layer) thickness, and Pattern-reversal Visual evoked potential (PR-VEP) were compared and analyzed. A total of 32 eyes of 16 patients were evaluated. Based on the best-corrected visual acuity (BCVA), 24 eyes were relatively stable compared with the baseline evaluation, and 8 eyes had significant changes, including 5 eyes that showed improvement and 3 eyes that showed impairment. In all eyes, the changes in the best-corrected visual acuity were significantly correlated with the changes in the visual field index (VFI), mean defect (MD), and P100 of the visual evoked potential. In the eyes with relatively stable BCVA and those with an obvious improvement in the BCVA, only the visual mean defect showed a significant change; the other indicators were not significantly different. Aside from the patients showing a tendency of spontaneous improvement, the others were in accordance with the requirement. The effects of Leber hereditary optical neuropathy (LHON) gene therapy should be evaluated primarily based on visual acuity. Additionally, visual field, neural fiber thickness, and electrophysiology should be considered in the evaluation. PMID:27749593

  6. Tolvaptan use in cancer patients with hyponatremia due to the syndrome of inappropriate antidiuretic hormone: a post hoc analysis of the SALT-1 and SALT-2 trials.

    PubMed

    Gralla, Richard J; Ahmad, Fatima; Blais, Jaime D; Chiodo, Joseph; Zhou, Wen; Glaser, Linda A; Czerwiec, Frank S

    2017-03-02

    Hyponatremia is a common electrolyte disorder in cancer patients and has been associated with poor prognosis. A frequent cause of cancer-related hyponatremia is the syndrome of inappropriate antidiuretic hormone (SIADH). This study was a post hoc subgroup analysis of the SALT-1 (Study of Ascending Levels of Tolvaptan in Hyponatremia) and SALT-2 clinical trials. Hyponatremic subjects with SIADH and cancer received the oral selective vasopressin V2-receptor antagonist tolvaptan (n = 12) or matching placebo (n = 16) once-daily for 30 days. The initial tolvaptan dose (15 mg) was titrated over 4 days to 30 or 60 mg per day, as needed, according to serum sodium level and tolerability. Baseline serum sodium levels in the SIADH/cancer cohort of the SALT trials was 130 and 128 mEq/L for tolvaptan and placebo, respectively. Mean change from baseline in average daily serum sodium AUC for tolvaptan relative to placebo was 5.0 versus -0.3 mEq/L (P < 0.0001) at day 4, and 6.9 versus 1.0 mEq/L (P < 0.0001) at day 30; the observed treatment effects were similar to those in the overall SIADH population (i.e., with and without cancer) at both time points. Serum sodium normalization was observed in 6/12 and 0/13 subjects at day 4 and 7/8 and 2/6 subjects at day 30 in the tolvaptan and placebo groups, respectively (P < 0.05 for both). Common treatment-emergent AEs for tolvaptan were consistent with previously reported results. In this post hoc study of the SALT trial population, oral tolvaptan was an effective and safe therapy for the treatment of hyponatremia in subjects with SIADH and cancer.

  7. Efficacy of the epidural blood patch for the treatment of post lumbar puncture headache BLOPP: A randomised, observer-blind, controlled clinical trial [ISRCTN 71598245

    PubMed Central

    Oedit, R; van Kooten, F; Bakker, SLM; Dippel, DWJ

    2005-01-01

    Background Post dural punction headache (PDPH) occurs in 10% to 40% of the patients who had a lumbar puncture. Its symptoms can be severe and incapacitating. The epidural blood patch is widely accepted as the treatment of choice for postdural puncture headache. Uncontrolled studies report rapid recovery after patching in 90% to 100% of treated patients. However, sufficient evidence from randomised, controlled clinical trials is lacking. Methods BLOPP (blood patch for post dural puncture headache) is a randomised, single centre, observer-blind clinical trial. Patients with PDPH for at least 24 hours and at most 7 days after lumbar puncture will be randomised to treatment with an epidural blood patch (EDBP) or to conventional treatment, i.e. 24 hours bed rest and ample fluid intake. PDPH 24 hours after treatment, classified on a 4-point scale (no, mild, moderate, severe) is the primary outcome. The secondary outcome is the presence of PDPH 7 days after treatment. We estimated that a sample size of 2 × 20 patients would provide us with a power of 80% to detect a relative reduction in number of patients with persisting PDPH after 24 hours of 50% at the usual significance level α = 5%, taking into account that in approximately 10% of the patients the PDPH will have resolved spontaneously after one day. Discussion The EDBP is accepted as the treatment of choice for PDPH although randomised, controlled data is scarce. Our randomised, observer-blind clinical trial enables us to compare the efficacy of two clinically practiced methods of PDPH treatment; EDBP versus conventional treatment, as they are applied in clinical practise. PMID:15998467

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

    PubMed

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

    2012-12-01

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

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

    PubMed Central

    2013-01-01

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

  10. Phase I trial evaluating the antiviral agent Cidofovir in combination with chemoradiation in cervical cancer patients

    PubMed Central

    Deutsch, Eric; Haie-Meder, Christine; Bayar, Mohamed Amine; Mondini, Michele; Laporte, Mélanie; Mazeron, Renaud; Adam, Julien; Varga, Andrea; Vassal, Gilles; Magné, Nicolas; Chargari, Cyrus; Lanoy, Emilie; Pautier, Patricia; Levy, Antonin; Soria, Jean-Charles

    2016-01-01

    Purpose This phase I trial aimed to assess the safety and determine the recommended Phase II dose (RP2D) of Cidofovir combined with chemoradiotherapy in patients with stage IB2-IVA cervical cancer. Experimental design Incremental doses (1, 2.5, 5 and 6.5 mg/kg) of IV Cidofovir were administered weekly for two weeks, and then every 2 weeks from the start of chemoradiotherapy to the initiation of utero-vaginal brachytherapy. Biological expression of HPV was analyzed during treatment and tumor response was assessed according to RECIST v1.0 criteria. Results A total of 15 patients were treated with Cidofovir. Dose-limiting toxicities occurred in 2/6 patients at the 6.5 mg/kg dose level (G3 proteinuria, and G3 acute pyelonephritis with G3 febrile neutropenia). No toxicity occurred at the 5 mg/kg dose level, but only 3 patients received this dose due to trial interruption because of low accrual. The most frequent G3-4 adverse effects observed during the trial were: abdominal pain (n=3), infection (n=2), leuckoneutropenia (n=2), and others (n=6). No toxic death or major renal side effect occurred. The best response was that 8/9 evaluable patients achieved a complete response (89%). In the intention to treat population, the 2-year overall and progression-free survival rates were 93% and 76%, respectively. Biological monitoring of HPV-related markers (decreased p16 expression, and increased p53 and pRb levels) was possible on sequential tumor biopsy samples. The genomic alterations identified were PIK3CA (n=5; one also had a KRAS mutation), and HRAS (n=1) mutations. Conclusion Cidofovir at a dose of 5mg/kg combined with chemoradiotherapy appeared tolerable and yielded tumor regressions. Due to early trial interruption, the RP2D was not confirmed. PMID:27016411

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

    2014-01-01

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

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

    NASA Technical Reports Server (NTRS)

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

    2007-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2007-01-01

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

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

    SciTech Connect

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

    2007-01-30

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

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

    SciTech Connect

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

    2012-01-15

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

  18. Selenium and vitamin E for prostate cancer: post-SELECT (Selenium and Vitamin E Cancer Prevention Trial) status.

    PubMed

    Ledesma, Mark C; Jung-Hynes, Brittney; Schmit, Travis L; Kumar, Raj; Mukhtar, Hasan; Ahmad, Nihal

    2011-01-01

    Various formulations of selenium and vitamin E, both essential human dietary components, have been shown to possess a therapeutic and preventive effect against prostate cancer. Fortuitous results of clinical trials also implied a risk-reduction effect of selenium and vitamin E supplements. The Selenium and Vitamin E Cancer Prevention Trial (SELECT), using oral selenium and vitamin E supplementation in disease-free volunteers, was designed to test a prostate cancer chemoprevention hypothesis. SELECT was terminated early because of both safety concerns and negative data for the formulations and doses given. Here, we review and discuss the studies done before and since the inception of SELECT, as well as the parameters of the trial itself. We believe that there is a lack of appropriate in vivo preclinical studies on selenium and vitamin E despite many promising in vitro studies on these agents. It seems that the most effective doses and formulations of these agents for prostate cancer chemoprevention have yet to be tested. Also, improved understanding of selenium and vitamin E biology may facilitate the discovery of these doses and formulations.

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

    EPA Science Inventory

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

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

    PubMed Central

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

    2016-01-01

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

  1. Enhanced Medical Rehabilitation increases therapy intensity and engagement and improves functional outcomes in post-acute rehabilitation of older adults: a randomized controlled trial

    PubMed Central

    Lenze, Eric J.; Host, Helen H.; Hildebrand, Mary W.; Morrow-Howell, Nancy; Carpenter, Brian; Freedland, Kenneth E.; Baum, Carolyn A.; Dixon, David; Doré, Peter; Wendleton, Leah; Binder, Ellen F.

    2012-01-01

    Objectives For millions of disabled older adults each year, post-acute care in skilled nursing facilities (SNFs) is a brief window of opportunity to regain enough function to return home and live independently. Too often this goal is not achieved, possibly due to therapy that is inadequately intense or engaging. This study tested Enhanced Medical Rehabilitation, an intervention designed to increase patient engagement in, and intensity of, daily physical and occupational therapy sessions in post-acute care rehabilitation. Design Randomized controlled trial of Enhanced Medical Rehabilitation versus standard-of-care rehabilitation. Setting Post-acute care unit of a skilled nursing facility in St Louis, MO. Participants 26 older adults admitted from a hospital for post-acute rehabilitation. Intervention Based on models of motivation and behavior change, Enhanced Medical Rehabilitation is a set of behavioral skills for physical and occupational therapists (PT/OT) that increase patient engagement and intensity, with the goal of improving functional outcome, through: (1) a patient-directed, interactive approach, (2) increased rehabilitation intensity, and (3) frequent feedback to patients on their effort and progress. Measurements Therapy intensity: assessment of patient active time in therapy sessions. Therapy engagement: Rehabilitation Participation Scale. Functional and performance outcomes: Barthel Index, gait speed, and six-minute walk. Results Participants randomized to Enhanced Medical Rehabilitation had higher intensity therapy and were more engaged in their rehabilitation sessions; they had more improvement in gait speed (improving from 0.08 to 0.38 meter/sec vs. 0.08 to 0.22 in standard of care,p=0.003) and six-minute walk (from 73 to 266 feet vs. 40 to 94 feet in standard of care, p=0.026), with a trend for better improvement of Barthel Index (+43 points vs. 26 points in standard of care, p=0.087), compared to participants randomized to standard

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

    PubMed Central

    2014-01-01

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

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

    PubMed

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

    2012-01-03

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

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

    PubMed

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

    2007-10-01

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

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

    USGS Publications Warehouse

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

    2012-01-01

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

  6. Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial

    PubMed Central

    Williams, Margiad Elen; Hastings, Richard; Charles, Joanna Mary; Evans, Sue; Hutchings, Judy

    2017-01-01

    Introduction Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs. Methods and analysis The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3–8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes. Ethics and dissemination Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016–15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer

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

    NASA Technical Reports Server (NTRS)

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

    2016-01-01

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

  8. Evaluation of the flexural strength of carbon fiber-, quartz fiber-, and glass fiber-based posts.

    PubMed

    Galhano, Graziela Avila; Valandro, Luiz Felipe; de Melo, Renata Marques; Scotti, Roberto; Bottino, Marco Antonio

    2005-03-01

    This study investigated the flexural strength of eight fiber posts (one carbon fiber, one carbon/quartz fiber, one opaque quartz fiber, two translucent quartz fiber, and three glass fiber posts). Eighty fiber posts were used and divided into eight groups (n = 10): G1: C-POST (Bisco); G2: AESTHETI-POST (Bisco); G3: AESTHETI-PLUS (Bisco); G4: LIGHT-POST (Bisco); G5: D.T. LIGHT-POST (Bisco); G6: PARAPOST WHITE (Coltene); G7: FIBERKOR (Pentron); G8: REFORPOST (Angelus). All of the samples were tested using the three-point bending test. The averages obtained were submitted to the ANOVA and to Tukey's test (p < 0.05). The mean values (MPa) of the groups AESTHETI-POST-carbon/quartz fiber post (Bisco) and AESTHETI-PLUS-quartz fiber post (Bisco) were statistically similar and higher than the mean values of the other groups. The mean values of the groups C-POST-carbon fiber post (Bisco), LIGHT-POST-translucent quartz fiber post (Bisco), D.T. LIGHT-POST-double tapered translucent quartz fiber post (Bisco), PARAPOST WHITE-glass fiber post (Coltene) and FIBREKOR--glass fiber post (Pentron) were similar and higher than the group REFORPOST-glass fiber post (Angelus).

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

    PubMed

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

    2015-12-01

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

  10. AAPL Practice Guideline for the forensic psychiatric evaluation of competence to stand trial.

    PubMed

    Mossman, Douglas; Noffsinger, Stephen G; Ash, Peter; Frierson, Richard L; Gerbasi, Joan; Hackett, Maureen; Lewis, Catherine F; Pinals, Debra A; Scott, Charles L; Sieg, Karl G; Wall, Barry W; Zonana, Howard V

    2007-01-01

    Competence to stand trial is a legal construct used to identify those criminal defendants who have the requisite mental capacity to understand the nature and objective of the proceedings against them and to participate rationally in preparing their defense. This Practice Guideline has described how psychiatrists should evaluate individuals concerning their competence to stand trial. The Guideline describes acceptable forensic psychiatric practice for such evaluations. Where possible, it specifies standards of practice and principles of ethics and also emphasizes the importance of analyzing an individual defendant's case in the context of statutes and case law applicable in the jurisdiction where the evaluation takes place. The recommendations in the Guideline both reflect and are limited by evolving case law, statutory requirements, legal publications, and the current state of psychiatric knowledge. The authors have taken note of nationally applicable case law, federal constitutional standards, statutory language, and federal and state interpretations of the rights or statutes, recognizing that jurisdictions may differ in their specific interpretation or application of statutes or general constitutional standards. The review of cases concerning specific psychiatric diagnoses illustrates general U.S. trends, and psychiatrists must remain cognizant of their jurisdictions' interpretations of statutes or constitutional requirements. By surveying a variety of practices and approaches to data gathering and case analysis, the authors believe that this Guideline will stimulate additional collegial discussion about what is necessary and sufficient for adequate evaluations of adjudicative competence. The notion that psychiatrists should apply expertise to competence assessments stems from the principal that, before allowing a defendant to face criminal prosecution and possible punishment, courts need reasonable assurance--based, if necessary, on a careful, individualized

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

    PubMed Central

    Kriegeskorte, Nikolaus

    2012-01-01

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

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

    PubMed

    Kriegeskorte, Nikolaus

    2012-01-01

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

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

    PubMed Central

    2014-01-01

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

  14. Evaluation of Post-stroke Spastic Muscle Stiffness Using Shear Wave Ultrasound Elastography.

    PubMed

    Wu, Chueh-Hung; Ho, Yu-Chun; Hsiao, Ming-Yen; Chen, Wen-Shiang; Wang, Tyng-Guey

    2017-03-09

    Current clinical evaluations of post-stroke upper limb spasticity are subjective and qualitative. We proposed a quantitative measurement of post-stroke spastic muscle stiffness by using shear-wave ultrasound elastography and tested its reliability. Acoustic radiation force impulse with shear wave velocity (SWV) detection was used to evaluate stiffness of the biceps brachii muscles at 90° and 0° elbow flexion. In 21 control subjects, SWV did not significantly differ between dominant and non-dominant sides at either flexion angle (0°: p = 0.311, 90°: p = 0.436). In 31 patients who had recent stroke, SWV was significantly greater on the paretic side than on the non-paretic side at both 90° (2.23 ± 0.15 m/s vs. 1.88 ± 0.08 m/s, p = 0.036) and 0° (3.28 ± 0.11 m/s vs. 2.93 ± 0.06 m/s, p = 0.002). The physical appearance of arms and forearms of our patients and controls prevented blinding of the rater to paretic or non-paretic side. At 90°, SWV on the paretic side correlated positively with modified Ashworth scale and modified Tardieu scale (spasticity severity) and negatively with Stroke Rehabilitation Assessment of Movement score (motor function impairment). The intra-class correlation coefficients of intra-rater and inter-rater reliability for SWV measurements were classified as excellent. In conclusion, high SWV was associated with high spasticity and poor function of the post-stroke upper limb, suggesting possible use as a reliable quantitative measure for disease progression and treatment follow-up.

  15. A Randomized Controlled Trial (RCT) to Assess and Improve the Effectiveness of Post-Deployment Screening for Mental Illness

    DTIC Science & Technology

    2014-09-01

    to their scores on the mental health measures . 8,673 (85%) out of 10,200 service personnel completed the baseline assessment. Follow up data...appraise the value of screening for mental illness in the service and also the beliefs of medical and welfare officers on an eventual post...experiences of the value of a screening programme for mental illness among UK military personnel. Method Three months after returning from

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

    PubMed

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

    2015-04-01

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

  17. Balance evaluation techniques and physical therapy in post-stroke patients: A literature review.

    PubMed

    Lendraitienė, Eglė; Tamošauskaitė, Agnė; Petruševičienė, Daiva; Savickas, Raimondas

    A stroke (cerebrovascular accident - CVA) is a significant social-economic issue. Approximately 15-30% of all patients develop life-long disability, 20% require over 3 months of specialized care in healthcare institutions, and the majority of the patients never recover the ability to maintain a proper vertical position. Such CVA sequelae as balance disturbances not only negatively affect patients' daily physical activity, but also result in social isolation. A number of standardized clinical scales, tests, and instrumental examination techniques have been proposed for evaluating not only post-CVA balance function, but also any changes in this function following various interventions. Even though scientific literature lists numerous methods and instruments for the improvement of balance after a CVA, not all of them are equally effective, and there have been rather controversial evaluations of some techniques. Nevertheless, the application of the majority of the techniques as complementary or alternative measures to traditional physical therapy (PT) frequently yields better results.

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

    PubMed Central

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

    2015-01-01

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

  19. A randomized, placebo-controlled, double-blind trial on the management of post-infective cough by inhaled ipratropium and salbutamol administered in combination.

    PubMed

    Zanasi, Alessandro; Lecchi, Marzia; Del Forno, Manuela; Fabbri, Elisa; Mastroroberto, Marianna; Mazzolini, Massimiliano; Pisani, Lara; Pandolfi, Paolo; Nava, Stefano; Morselli-Labate, Antonio Maria

    2014-12-01

    Post-viral cough is a type of cough originating from upper respiratory tract infections that persists after the infection is resolved. Although it was hypothesized that bronchodilators might have a role in the management of post-viral cough, a clear demonstration of their efficacy is missing. Therefore, we tested the efficacy of a combination of a β-agonist and an anticholinergic agent in reducing post-viral cough with a randomized, double blind, placebo controlled clinical trial. Patients were treated for 10 days with either a nebulized combination of salbutamol 1.875 mg/0.5 mL and ipratropium bromide 0.375 mg/0.5 mL, or a placebo, and followed up for another 10 days. Daytime and nighttime cough severity and spirometry testing were assessed before starting treatment, after 10 and 20 days. Ninety-two patients were randomized to receive placebo (n = 46) or the active treatment (n = 46); nine of them (4 in the placebo group, 5 in the active treatment group) dropped out from the study. Daytime and nighttime cough severity were significantly reduced in both groups during the study period, but the reduction was more prominent in the active treatment group vs. placebo after 10 days of treatment (P = 0.003 for day cough; P = 0.061 for night cough), whereas at the end of follow-up period cough severity was comparable between the two groups. Small but significant increases in spirometric parameters were observed in the active treatment vs. placebo group, although at the end of follow-up these values returned to be comparable to placebo. The frequency of adverse events was not significantly different between the two groups of patients. We concluded that a combination of a β-agonist and an anticholinergic agent can effectively reduce post-viral cough, and can thus represent a valid option for this type of cough.

  20. Usefulness of pre- and post-operative calcium and Vitamin D supplementation in prevention of hypocalcemia after total thyroidectomy: A randomized controlled trial

    PubMed Central

    Jaan, Sumiya; Sehgal, Ashish; Wani, Rauf Ahmad; Wani, Muneer Ahmad; Wani, Khursheed Alam; Laway, Bashir Ahmad

    2017-01-01

    Background: Total thyroidectomy (TT) is a commonly performed surgery and postoperative hypocalcemia is a major detriment to early discharge. The aim of this randomized controlled trial was to ascertain the usefulness of routine pre- and post-operative calcium and Vitamin D supplementation in prevention of hypocalcemia after TT. Materials and Methods: Sixty consecutive patients who underwent total or near TT from February 2013 to August 2014 were included in the study. They were randomly divided into two groups - Group 1 received oral calcium (500 mg every 6 h) and Vitamin D (calcitriol 0.25 mcg every 6 h) 7 days before and 7 days after the surgery; and Group 2 did not receive supplementation. Symptoms and signs of hypocalcemia were monitored. Calcium profile was measured pre- and post-operatively at 6, 12, 24, 48, 72 h, and on 30th day. Hypocalcemia after surgery was either symptomatic or laboratory documented. Serum calcium level ≤ 8.5 mg/dl was considered as laboratory hypocalcemia. Results: Twelve patients from Group 2, and 3 patients from Group 1 developed symptomatic hypocalcemia (P < 0.01). Laboratory hypocalcemia within postoperative 24 h was comparable between two groups, but more patients of Group 2 compared to Group 1 developed hypocalcemia at 48 h (6 and 13, respectively; P = 0.04) and at 72 h after surgery (5 and 14, respectively; P = 0.01). Twenty-four hours postoperative serum calcium level was significantly associated with grade of goiter, preoperative calcium, and nature of thyroid disease (benign or malignant). On multiple linear regression analysis, preoperative serum calcium was only independent variable significantly associated with development of 24 h post-TT hypocalcemia. Conclusion: Routine pre- and post-TT calcium and Vitamin D supplementation can significantly reduce postoperative hypocalcemia. PMID:28217498

  1. Effectiveness of hospital-based geriatric evaluation and management and home intervention team (GEM-HIT). Rationale and design of a 5-year randomized trial.

    PubMed

    Nikolaus, T; Specht-Leible, N; Bach, M; Wittmann-Jennewein, C; Oster, P; Schlierf, G

    1995-01-01

    In this ongoing randomized controlled trial the effectiveness of an interdisciplinary team implementing hospital-based comprehensive geriatric assessment (CGA) and home intervention is being studied. All patients admitted from home showing functional decline with impairment of any basic activity of daily living are randomly assigned to one of the following courses of treatment: CGA with in-hospital and post discharge management by a home intervention team (HIT), where necessary (group 1): CGA with recommendations and usual care at home (group 2); or usual hospital and home care (group 3). The HIT consists of 3 nurses, 1 geriatrician, 1 physiotherapist, 1 occupational therapist, and 1 social worker. 540 patients will be recruited for the trial, which will assess the effects of GEM-HIT on the following outcomes: health status, functional status, survival, hospital readmission, nursing home placement and costs. The purpose of the GEM-HIT trial is to answer many of the current questions concerning treatment and health care delivery for frail older persons under the specific conditions found in Germany. The large sample size and the broad range of diagnoses included in the study will allow the evaluation of effects of GEM-HIT for subgroups and may help to identify the most effective assessment tools for use within our particular context.

  2. Evaluation of clinical, antiinflammatory and antiinfective properties of amniotic membrane used for guided tissue regeneration: A randomized controlled trial

    PubMed Central

    Kumar, Aravind; Chandra, Rampalli Viswa; Reddy, Aileni Amarender; Reddy, Bavigadda Harish; Reddy, Chakravarthy; Naveen, Anumala

    2015-01-01

    Background: The objective of this study was to evaluate the antiinflammatory, antiinfective and clinical properties of amniotic membrane (AM) when used for guided tissue regeneration (GTR) in contained interdental defects. Materials and Methods: A total of 30 subjects participated in this study. Two sites in each subject were randomly assigned into each of the following experimental groups; test group: AM with bone graft and control group: Bone graft only. Clinical parameters included recording site-specific measures of plaque, gingivitis, probing pocket depth (PPD), and clinical attachment loss (CAL). The levels of interleukin-1β (IL-1β) and human beta-defensin-2 (hBD-2) levels in gingival crevicular fluid (GCF) from the test and control sites were measured by using commercially available enzyme linked immunosorbent assay kits. The evaluation of bone fill was performed by using digital subtraction technique and morphometric area analysis. One-way analysis of variance followed by the post-hoc test was used for intragroup and intergroup comparison. A P < 0.05 was considered as statistically significant. Results: Combination therapy using an AM increased bone fill and reduced PPD and CAL when compared to controls. AM also resulted in a significant reduction of GCF IL-1β levels and insignificant increase in the hBD-2 levels. Conclusion: From this trial conducted over a period of 24 weeks, AM demonstrated a marked antiinflammatory effect and its use resulted in an improvement in periodontal parameters. AM has the potential to function as a barrier for GTR and the unique properties associated with this material can augment its potential as a matrix for periodontal regeneration. PMID:25878677

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed

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

    2015-11-01

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

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

    PubMed Central

    2013-01-01

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

  6. Evaluation of post-mortem oxymetry with reference to the causes of death.

    PubMed

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

    1997-06-23

    We examined blood samples of 214 forensic autopsy cases, excluding fire victims, on a CO-oximeter system in order to evaluate post-mortem oxymetric profiles with reference to the causes of death. Oxyhemoglobin (O2-Hb) levels in the left and right heart blood, respectively, ranged from 0 to 97.7% and from 0 to 92.1%, showing no apparent correlation with the post-mortem intervals or rectal temperatures. In nearly 60% of the cases, O2-Hb was lower than 10%. A high O2-Hb level (over 50%) in the left heart blood was most frequently observed in death from cold exposure and occasionally in fatalities from blunt injuries and stab/incised wounds with or without medical care. O2-Hb in the heart blood was usually very low (under 10%) in fatalities from asphyxiation, drowning, poisoning and natural diseases. A greatest oxymetric variation was observed in death from injuries, probably due to varied causal mechanisms of death. In most cases, the differences between blood O2-Hb levels in the heart and iliac vessels were within 15%; whereas O2-Hb in the cerebral venous blood was usually evidently higher than that in the right heart blood. An inverse relation of O2-Hb levels to total hemoglobin contents was observed slightly for the blood in the heart and iliac vessels, and more obviously for the cerebral venous blood. The above post-mortem oxymetric profiles were considered to at least partially reflect the final balance of oxygen uptake and consumption in dying process, possibly also affected by the circulatory status, giving an objective index to the color of cadaveric blood (hypostasis), although it should be assessed in consideration of post-mortem interference and total hemoglobin contents. In any case, however, post-mortem oxymetry seemed to have a limited value owing to severe systemic hypoxia which would be a common final state before death from various fatal traumas and diseases, maybe except for those with extremely short agony.

  7. Enhancing the Application and Evaluation of a Discrete Trial Intervention Package for Eliciting First Words in Preverbal Preschoolers with ASD

    ERIC Educational Resources Information Center

    Tsiouri, Ioanna; Simmons, Elizabeth Schoen; Paul, Rhea

    2012-01-01

    This study evaluates the effectiveness of an intervention package including a discrete trial program (Rapid Motor Imitation Antecedent Training (Tsiouri and Greer, "J Behav Educat" 12:185-206, 2003) combined with parent education for eliciting first words in children with ASD who had little or no spoken language. Evaluation of the approach…

  8. Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices.

    PubMed

    Mahmoud, Karim D; Lennon, Ryan J; Holmes, David R

    2015-08-01

    Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. However, an accurate estimation of the event rate is crucial for their ability to test clinical hypotheses. Overestimation of event rates reduces the required sample size but can compromise the statistical power of the RCT. Little is known about the prevalence, extent, and impact of overestimation of event rates. The latest RCTs on 10 preselected topics in the field of cardiovascular interventions and devices were selected, and actual primary event rates in the control group were compared with their respective event rate estimations. We also assessed what proportion of the nonsignificant RCTs was truly able to exclude a relevant treatment effect. A total of 27 RCTs randomizing 19,436 patients were included. The primary event rate in the control group was overestimated in 20 of the 27 RCTs (74.1%) resulting in a substantial relative difference between observed and estimated event rates (mean -22.9%, 95% confidence interval -33.5% to -12.2%; median -16.3%, 95% confidence interval -30.3% to -6.5%). Event rates were particularly overestimated in RCTs on biodegradable polymer drug-eluting coronary stents and renal artery stenting. Of the 14 single end point superiority trials with nonsignificant results, only 3 (21.4%) actually resulted in truly negative conclusions. In conclusion, event rates in RCTs evaluating cardiovascular interventions and devices are frequently overestimated. This under-reported phenomenon has fundamental impact on the design of RCTs and can have an adverse impact on the statistical power of these trials to answer important questions about therapeutic strategies.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2016-09-01

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

  11. Systematic evaluation of autoregressive error models as post-processors for a probabilistic streamflow forecast system

    NASA Astrophysics Data System (ADS)

    Morawietz, Martin; Xu, Chong-Yu; Gottschalk, Lars; Tallaksen, Lena

    2010-05-01

    A post-processor that accounts for the hydrologic uncertainty in a probabilistic streamflow forecast system is necessary to account for the uncertainty introduced by the hydrological model. In this study different variants of an autoregressive error model that can be used as a post-processor for short to medium range streamflow forecasts, are evaluated. The deterministic HBV model is used to form the basis for the streamflow forecast. The general structure of the error models then used as post-processor is a first order autoregressive model of the form dt = αdt-1 + σɛt where dt is the model error (observed minus simulated streamflow) at time t, α and σ are the parameters of the error model, and ɛt is the residual error described through a probability distribution. The following aspects are investigated: (1) Use of constant parameters α and σ versus the use of state dependent parameters. The state dependent parameters vary depending on the states of temperature, precipitation, snow water equivalent and simulated streamflow. (2) Use of a Standard Normal distribution for ɛt versus use of an empirical distribution function constituted through the normalized residuals of the error model in the calibration period. (3) Comparison of two different transformations, i.e. logarithmic versus square root, that are applied to the streamflow data before the error model is applied. The reason for applying a transformation is to make the residuals of the error model homoscedastic over the range of streamflow values of different magnitudes. Through combination of these three characteristics, eight variants of the autoregressive post-processor are generated. These are calibrated and validated in 55 catchments throughout Norway. The discrete ranked probability score with 99 flow percentiles as standardized thresholds is used for evaluation. In addition, a non-parametric bootstrap is used to construct confidence intervals and evaluate the significance of the results. The main

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

    PubMed Central

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

    2007-01-01

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

  13. The IDEAL DVT study, individualised duration elastic compression therapy against long-term duration of therapy for the prevention of post-thrombotic syndrome: protocol of a randomised controlled trial

    PubMed Central

    ten Cate-Hoek, Arina J; Bouman, Annemieke C; Joore, Manuela A; Prins, Martin; ten Cate, Hugo

    2014-01-01

    Introduction Post-thrombotic syndrome (PTS) is a serious complication of deep vein thrombosis (DVT) of the leg that affects 20–50% of patients. Once a patient experiences PTS there is no treatment that effectively reduces the debilitating complaints. Two randomised controlled trials showed that elastic compression stocking (ECS) therapy after DVT for 24 months can reduce the incidence of PTS by 50%. However, it is unclear whether all patients benefit to the same extent from ECS therapy or what the optimal duration of therapy for individual patients should be. ECS therapy is costly, inconvenient, demanding and sometimes even debilitating. Tailoring therapy to individual needs could save substantial costs. The objective of the IDEAL DVT study, therefore, is to evaluate whether tailoring the duration of ECS therapy on signs and symptoms of the individual patient is a safe and effective method to prevent PTS, compared with standard ECS therapy. Methods and analysis A multicentre, single-blinded, allocation concealed, randomised, non-inferiority trial. A total of 864 consecutive patients with acute objectively documented proximal DVT of the leg are randomised to either standard duration of 24 months or tailored duration of ECS therapy following an initial therapeutic period of 6 months. Signs and symptoms of PTS are recorded at regular clinic visits. Furthermore, quality of life, costs, patient preferences and compliance are measured. The primary outcome is the proportion of patients with PTS at 24 months. Ethics and dissemination Based on current knowledge the standard application of ECS therapy is questioned. The IDEAL DVT study will address the central questions that remain unanswered: Which individual patients benefit from ECS therapy and what is the optimal individual treatment duration? Primary ethics approval was received from the Maastricht University Medical Centre. Results Results of the study will be disseminated via peer-reviewed publications and

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

    PubMed Central

    2009-01-01

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

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

    PubMed Central

    2013-01-01

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

  16. Field trials of a vaccine against bovine mastitis. 2. Evaluation in two commercial dairy herds.

    PubMed

    Calzolari, A; Giraudo, J A; Rampone, H; Odierno, L; Giraudo, A T; Frigerio, C; Bettera, S; Raspanti, C; Hernández, J; Wehbe, M; Mattea, M; Ferrari, M; Larriestra, A; Nagel, R

    1997-05-01

    A vaccine against bovine mastitis was developed. The vaccine was based on inactivated, highly encapsulated Staphylococcus aureus cells; a crude extract of Staph. aureus exopolysaccharides; and inactivated unencapsulated Staph. aureus and Streptococcus spp. cells. In this study, the vaccine was evaluated in 164 cows from two commercial dairies (A and B) during a 4-mo period. Two doses of the vaccine were administered subcutaneously to 82 cows in the brachiocephalicus muscle of the neck within a 4-wk interval. The results of this trial revealed significantly fewer intramammary infections caused by Staph. aureus at various levels of severity (clinical, subclinical, and latent) in cows that were vaccinated. The odds ratios of all types of intrammammary infections caused by Staph. aureus for dairies A and B, which were determined by a logistic model, were 1.84 and 1.89, respectively, for quarters of vaccinated cows and quarters of control cows. The colony counts for Staph. aureus in milk from infected quarters of vaccinated cows were significantly lower than those in milk from infected quarters of control cows. Also, the somatic cell counts per milliliter in milk from vaccinated cows were significantly decreased when the initial somatic cell count was < 500,000 cells/ml at the start of the trial. The vaccine had no observable effect on fat production in milk or on streptococcal infections.

  17. Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial.

    PubMed

    Beckett, Charmagne G; Tjaden, Jeffrey; Burgess, Timothy; Danko, Janine R; Tamminga, Cindy; Simmons, Monika; Wu, Shuenn-Jue; Sun, Peifang; Kochel, Tadeusz; Raviprakash, Kanakatte; Hayes, Curtis G; Porter, Kevin R

    2011-01-29

    Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME(100)). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0mg, n=12) or a low dose (1.0mg, n=10) DNA vaccine using the needle-free Biojector(®) 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.

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

    PubMed Central

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

    2016-01-01

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

  19. Metronidazole (Flagyl) and Arnica Montana in the prevention of post-surgical complications, a comparative placebo controlled clinical trial.

    PubMed

    Kaziro, G S

    1984-02-01

    A double blind trial, was designed, in which 118 patients undergoing the removal of impacted wisdom teeth were randomly divided into the following groups; 41 patients received Metronidazole, 39 patients received Arnica Montana, 38 patients received the placebo. Metronidazole was more effective in pain control than Arnica (p less than 0.001) and placebo (p less than 0.01). It prevented swelling better than Arnica (p less than 0.01) and placebo (p less than 0.05) and was more effective in promoting healing than Arnica (p less than 0.01) and placebo (p greater than 0.02). Arnica Montana appeared to give rise to greater pain than placebo (p less than 0.05) and caused more swelling than the placebo (p less than 0.01).

  20. Chronotherapeutic oral drug absorption system verapamil is effective in reducing morning blood pressure in African Americans: a post hoc analysis of the chrono trial.

    PubMed

    Prisant, L Michael; Weber, Michael; Black, Henry R

    2005-03-01

    Results of several clinical trials have shown that verapamil is effective in reducing blood pressure (BP) in African Americans, a population at high risk for hypertension and target-organ damage. Nonetheless, adequate control of BP is perceived as difficult to achieve in this population. A post hoc analysis of data from the community-based CHRONO trial (Controlling Hypertension in the moRning with a ChrONO medication) was undertaken to assess racial/ethnic differences in the safety and efficacy of the Chronotherapeutic Oral Drug Absorption System (CODAS) formulation of verapamil in a real-world setting. Once-daily administration of the CODAS formulation of verapamil significantly reduced morning BP (P<0.0001) regardless of race or ethnicity. In the African-American population (N=466), the response rate for systolic BP (<140 mmHg or > or =10% reduction from baseline) and diastolic BP (<90 mmHg or reduction > or =10 mmHg from baseline) combined was 70.8%, and 60% of those individuals responded at the lowest (200 mg) dose. Of the 59.7% of African Americans who reached the target BP of <140/90 mmHg, 64% did so at the 200-mg dose. Response rates were not affected by gender, age or treatment history, and CODAS-verapamil was well tolerated in all ethnic/racial treatment groups. In a trial conducted in actual clinical practices, the CODAS formulation of verapamil was shown to be safe and effective in African Americans, Caucasians, Hispanics and Asians.

  1. Intravenous injection of low-dose flurbiprofen axetil for preventing post-ERCP pancreatitis in high-risk patients: An interim analysis of the trial

    PubMed Central

    Fujita, Yuji; Hasegawa, Sho; Kato, Yuri; Ishii, Ken; Iwasaki, Akito; Sato, Takamitsu; Sekino, Yusuke; Hosono, Kunihiro; Nakajima, Atsushi; Kubota, Kensuke

    2016-01-01

    Background and study aims: Several meta-analyses and randomized control trials have demonstrated the efficacy of rectal nonsteroidal anti-inflammatory drugs for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Diclofenac or indomethacin was administered at a dose of 100 mg in those studies, which may be too high for Asian population. In addition, rectal administration can be considered complicated. Patients and methods: This study was a prospective, randomized, placebo-controlled trial. Patients with a PEP risk score ≥ 1 were randomly assigned to receive intravenous injection of 50 mg flurbiprofen axetil (flurbiprofen group) or saline only (placebo group). The primary outcome was reduced PEP. The secondary outcome was amylase level after 2 hours of ERCP as a predictor of PEP. (Clinical Trials.gov, ID UMIN000011322) Results: In total, 144 patients were enrolled from August 2013 to March 2015. We performed an interim analysis of the first 100 patients: 47 received flurbiprofen axetil and 53 received placebo. PEP occurred in 11 patients (11 %): 2 of 47 (4.3 %) in the flurbiprofen group and 9 of 53 (17 %) in the placebo group (P = 0.042). Relative risk reduction was 62.4 %. Hyperamylasemia did not differ significantly (17.0 % vs. 26.4 %, P = 0.109). This analysis resulted in early termination of the study for ethical reasons. Conclusions: Intravenous injection of low-dose flurbiprofen axetil after ERCP can reduce the incidence of PEP in high-risk patients PMID:27747282

  2. Linear Modeling and Evaluation of Controls on Flow Response in Western Post-Fire Watersheds

    NASA Astrophysics Data System (ADS)

    Saxe, S.; Hogue, T. S.; Hay, L.

    2015-12-01

    This research investigates the impact of wildfires on watershed flow regimes throughout the western United States, specifically focusing on evaluation of fire events within specified subregions and determination of the impact of climate and geophysical variables in post-fire flow response. Fire events were collected through federal and state-level databases and streamflow data were collected from U.S. Geological Survey stream gages. 263 watersheds were identified with at least 10 years of continuous pre-fire daily streamflow records and 5 years of continuous post-fire daily flow records. For each watershed, percent changes in runoff ratio (RO), annual seven day low-flows (7Q2) and annual seven day high-flows (7Q10) were calculated from pre- to post-fire. Numerous independent variables were identified for each watershed and fire event, including topographic, land cover, climate, burn severity, and soils data. The national watersheds were divided into five regions through K-clustering and a lasso linear regression model, applying the Leave-One-Out calibration method, was calculated for each region. Nash-Sutcliffe Efficiency (NSE) was used to determine the accuracy of the resulting models. The regions encompassing the United States along and west of the Rocky Mountains, excluding the coastal watersheds, produced the most accurate linear models. The Pacific coast region models produced poor and inconsistent results, indicating that the regions need to be further subdivided. Presently, RO and HF response variables appear to be more easily modeled than LF. Results of linear regression modeling showed varying importance of watershed and fire event variables, with conflicting correlation between land cover types and soil types by region. The addition of further independent variables and constriction of current variables based on correlation indicators is ongoing and should allow for more accurate linear regression modeling.

  3. Endovascular therapy for acute ischaemic stroke: the Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE) randomised, controlled trial

    PubMed Central

    Muir, Keith W; Ford, Gary A; Messow, Claudia-Martina; Ford, Ian; Murray, Alicia; Clifton, Andrew; Brown, Martin M; Madigan, Jeremy; Lenthall, Rob; Robertson, Fergus; Dixit, Anand; Cloud, Geoffrey C; Wardlaw, Joanna; Freeman, Janet; White, Philip

    2017-01-01

    Objective The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA). Design Eligible patients had IVT started within 4.5 hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90 min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0–2 at day 90. Results Ten UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13–21). Median stroke onset to IVT start was 120 min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0–1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0–2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021). Conclusions The trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability

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

    PubMed Central

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

    2007-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2007-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  8. An evaluation of computer-aided disproportionality analysis for post-marketing signal detection.

    PubMed

    Lehman, H P; Chen, J; Gould, A L; Kassekert, R; Beninger, P R; Carney, R; Goldberg, M; Goss, M A; Kidos, K; Sharrar, R G; Shields, K; Sweet, A; Wiholm, B E; Honig, P K

    2007-08-01

    To understand the value of computer-aided disproportionality analysis (DA) in relation to current pharmacovigilance signal detection methods, four products were retrospectively evaluated by applying an empirical Bayes method to Merck's post-marketing safety database. Findings were compared with the prior detection of labeled post-marketing adverse events. Disproportionality ratios (empirical Bayes geometric mean lower 95% bounds for the posterior distribution (EBGM05)) were generated for product-event pairs. Overall (1993-2004 data, EBGM05> or =2, individual terms) results of signal detection using DA compared to standard methods were sensitivity, 31.1%; specificity, 95.3%; and positive predictive value, 19.9%. Using groupings of synonymous labeled terms, sensitivity improved (40.9%). More of the adverse events detected by both methods were detected earlier using DA and grouped (versus individual) terms. With 1939-2004 data, diagnostic properties were similar to those from 1993 to 2004. DA methods using Merck's safety database demonstrate sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods.

  9. Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial.

    PubMed

    Nam, Hyung Seok; Park, Yoon Ghil; Paik, Nam-Jong; Oh, Byung-Mo; Chun, Min Ho; Yang, Hea-Eun; Kim, Dae Hyun; Yi, Youbin; Seo, Han Gil; Kim, Kwang Dong; Chang, Min Cheol; Ryu, Jae Hak; Lee, Shi-Uk

    2015-10-15

    Botulinum toxin A is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. Efficacy and safety of a new botulinum toxin type A, NABOTA (DWP450) in post-stroke upper limb spasticity was evaluated in comparison with Botox (onabotulinum toxin A). A total of 197 patients with post-stroke upper limb spasticity were included in this study and randomly assigned to NABOTA group (n=99) or Botox group (n=98). Wrist flexors with modified Ashworth Scale (MAS) grade 2 or greater, and elbow flexors, thumb flexors and finger flexors with MAS 1 or greater were injected with either drug. The primary outcome was the change of wrist flexor MAS between baseline and 4weeks post-injection. MAS of each injected muscle, Disability Assessment Scale (DAS), and Caregiver Burden Scale were also assessed at baseline and 4, 8, and 12weeks after the injection. Global Assessment Scale (GAS) was evaluated on the last visit at 12weeks. The change of MAS for wrist flexor between baseline and 4weeks post-injection was -1.44±0.72 in the NABOTA group and -1.46±0.77 in the Botox group. The difference of change between both groups was 0.0129 (95% confidence interval -0.2062-0.2319), within the non-inferiority margin of 0.45. Both groups showed significant improvements regarding MAS of all injected muscles, DAS, and Caregiver Burden Scale at all follow-up periods. There were no significant differences in all secondary outcome measures between the two groups. NABOTA demonstrated non-inferior efficacy and safety for improving upper limb spasticity in stroke patients compared to Botox.

  10. Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial.

    PubMed

    Arcoraci, Vincenzo; Atteritano, Marco; Squadrito, Francesco; D'Anna, Rosario; Marini, Herbert; Santoro, Domenico; Minutoli, Letteria; Messina, Sonia; Altavilla, Domenica; Bitto, Alessandra

    2017-02-22

    Genistein has a preventive role against bone mass loss during menopause. However, experimental data in animal models of osteoporosis suggest an anti-osteoporotic potential for this isoflavone. We performed a post-hoc analysis of a previously published trial investigating the effects of genistein in postmenopausal women with low bone mineral density. The parent study was a randomized, double-blind, placebo-controlled trial involving postmenopausal women with a femoral neck (FN) density <0.795 g/cm². A cohort of the enrolled women was, in fact, identified at the baseline as osteoporotic (n = 121) on the basis of their T-score and analyzed thereafter for the 24 months' treatment with either 1000 mg of calcium and 800 IU vitamin D3 (placebo; n = 59); or calcium, vitamin D3, and Genistein aglycone (54 mg/day; genistein; n = 62). According to the femoral neck T-scores, 31.3% of the genistein and 30.9% of the placebo recipients were osteoporotic at baseline. In the placebo and genistein groups, the 10-year hip fracture probability risk assessed by Fracture Risk Assessment tool (FRAX) was 4.1 ± 1.9 (SD) and 4.2 ± 2.1 (SD), respectively. Mean bone mineral density (BMD) at the femoral neck increased from 0.62 g/cm² at baseline to 0.68 g/cm² at 1 year and 0.70 g/cm² at 2 years in genistein recipients, and decreased from 0.61 g/cm² at baseline to 0.60 g/cm² at 1 year and 0.57 g/cm² at 2 years in placebo recipients. At the end of the study only 18 postmenopausal women had osteoporosis in the genistein group with a prevalence of 12%, whereas in the placebo group the number of postmenopausal women with osteoporosis was unchanged, after 24 months. This post-hoc analysis is a proof-of concept study suggesting that genistein may be useful not only in postmenopausal osteopenia but also in osteoporosis. However, this proof-of concept study needs to be confirmed by a large, well designed, and appropriately focused randomized clinical trial in a population at high risk of

  11. Antiosteoporotic Activity of Genistein Aglycone in Postmenopausal Women: Evidence from a Post-Hoc Analysis of a Multicenter Randomized Controlled Trial

    PubMed Central

    Arcoraci, Vincenzo; Atteritano, Marco; Squadrito, Francesco; D’Anna, Rosario; Marini, Herbert; Santoro, Domenico; Minutoli, Letteria; Messina, Sonia; Altavilla, Domenica; Bitto, Alessandra

    2017-01-01

    Genistein has a preventive role against bone mass loss during menopause. However, experimental data in animal models of osteoporosis suggest an anti-osteoporotic potential for this isoflavone. We performed a post-hoc analysis of a previously published trial investigating the effects of genistein in postmenopausal women with low bone mineral density. The parent study was a randomized, double-blind, placebo-controlled trial involving postmenopausal women with a femoral neck (FN) density <0.795 g/cm2. A cohort of the enrolled women was, in fact, identified at the baseline as osteoporotic (n = 121) on the basis of their T-score and analyzed thereafter for the 24 months’ treatment with either 1000 mg of calcium and 800 IU vitamin D3 (placebo; n = 59); or calcium, vitamin D3, and Genistein aglycone (54 mg/day; genistein; n = 62). According to the femoral neck T-scores, 31.3% of the genistein and 30.9% of the placebo recipients were osteoporotic at baseline. In the placebo and genistein groups, the 10-year hip fracture probability risk assessed by Fracture Risk Assessment tool (FRAX) was 4.1 ± 1.9 (SD) and 4.2 ± 2.1 (SD), respectively. Mean bone mineral density (BMD) at the femoral neck increased from 0.62 g/cm2 at baseline to 0.68 g/cm2 at 1 year and 0.70 g/cm2 at 2 years in genistein recipients, and decreased from 0.61 g/cm2 at baseline to 0.60 g/cm2 at 1 year and 0.57 g/cm2 at 2 years in placebo recipients. At the end of the study only 18 postmenopausal women had osteoporosis in the genistein group with a prevalence of 12%, whereas in the placebo group the number of postmenopausal women with osteoporosis was unchanged, after 24 months. This post-hoc analysis is a proof-of concept study suggesting that genistein may be useful not only in postmenopausal osteopenia but also in osteoporosis. However, this proof-of concept study needs to be confirmed by a large, well designed, and appropriately focused randomized clinical trial in a population at high risk of fractures

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

    PubMed Central

    2013-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

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

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

    NASA Technical Reports Server (NTRS)

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

    1973-01-01

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

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

    SciTech Connect

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

    1993-09-01

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

  17. A post-trial survey to assess the impact of dissemination of results and unmasking on participants in a 13-year randomised controlled trial on age-related cataract

    PubMed Central

    2011-01-01

    Background The Italian-American Clinical Trial of Nutritional Supplements and Age-Related Cataract was designed to assess the impact of a multivitamin-mineral supplement on age-related cataract. Trial results showed evidence of a beneficial effect of the supplement on all types of cataract combined, opposite effects on two of the three types of cataract (beneficial for nuclear opacities and harmful for posterior sub-capsular opacities) and no statistically significant effect on cortical opacities. No treatment recommendations were made. A post-trial survey was conducted on 817 surviving elderly participants to assess their satisfaction, their understanding of treatment assignment to supplement or placebo and the success of masking. Methods Trial results were communicated by letter and the level of satisfaction and of understanding of the results was assessed by a questionnaire. Participants were offered the option of being unmasked: a second questionnaire was administered to this subset to assess their understanding of the randomisation process and the success of masking. Results 610 participants (74.7%) responded to the survey: 94.6% thought the description of the results was "very clear" or "quite clear", 5.4% "not clear" or "do not know"; 89.8% considered the results "very interesting" or "quite interesting", 10.2% "not interesting" or "do not know"; 60.3% expressed "satisfaction", 17.2% "both satisfaction and concern", 2.6% "concern", 19.9% "indifference" or "do not know". 480 participants (78.7%) accepted the offer to be unmasked to their treatment assignment: 395 (82.3%) recalled/understood the possibility of assignment to vitamins or placebo, 85 (17.7%) did not. 68 participants (17.2%) thought they had taken vitamins (79.4% were correct; p = 0.0006), 47 (11.9%) thought they had taken placebo (59.6% were correct; p = 0.46) and 280 (70.9%) declared they did not know. Conclusions The results were made difficult to explain to study participants by the

  18. A randomised controlled trial of integrated electrical stimulation and physiotherapy to improve mobility for people less than 6 months post stroke.

    PubMed

    Wilkinson, Ingrid A; Burridge, Jane; Strike, Paul; Taylor, Paul

    2014-05-14

    Abstract Purpose: To investigate the feasibility of combining physiotherapy and functional electrical stimulation to improve gait post stroke. Methods: A parallel group partially single-blinded randomised clinical trial. Adults living at home, less than 6 months post stroke, were randomised to Group A (physiotherapy, n = 10) or Group B (physiotherapy and common peroneal nerve stimulation, n = 10). Assessments were conducted before randomisation (Week 1), after intervention (Week 8) and after 12 weeks follow-up (Week 20). Results: No between group differences were observed. There were statistically significant within group differences after the intervention period in both groups for walking speed and distance walked (without stimulation), Rivermead Mobility Index and Canadian Occupational Performance Measure, maintained at Week 20. There was statistically significant improvement in 10-m walking speed (Group B) when the stimulator was used at Week 8 (p = 0.03, median 0.04 m/s (8%)). Only Group B had statistically significant within group change in Rivermead Visual Gait Analysis (Week 8), maintained at Week 20. Conclusions: Integrating electrical stimulation and physiotherapy was feasible and improved walking speed. There was no evidence of a training effect compared with physiotherapy alone. One-hundred forty-four participants per group would produce an adequately powered study based on this protocol. Implications for Rehabilitation At the end of the intervention period participants using electrical stimulation to correct dropped foot walked faster. It was feasible for electrical stimulation to be combined with physiotherapy for people less than 6 months post stroke. A larger adequately powered study is required to establish whether there are training effects associated with use of stimulation in this population.

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

    PubMed

    Pozo, Eduardo; Sanz, Javier

    2014-09-01

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

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

    PubMed Central

    Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

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

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

    PubMed Central

    Kemaloglu, Hande; Pamir, Tijen; Tezel, Huseyin

    2016-01-01

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

  2. Theory-driven process evaluation of a complementary feeding trial in four countries

    PubMed Central

    Newman, Jamie E.; Garces, Ana; Mazariegos, Manolo; Michael Hambidge, K.; 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 tests to examine differences between treatment groups. We administered exit interviews to 219 caregivers and 45 intervention staff to explore why caregivers may or may not have performed suggested infant feeding behaviors. Multivariate regression analysis was used to determine the relationship between caregiver scores and infant linear growth velocity. As message recall increased, irrespective of treatment group, linear growth velocity increased when controlling for other factors (P < 0.05), emphasizing the importance of study messages. Our detailed process evaluation revealed few differences between treatment groups, giving us confidence that the main trial’s lack of effect to reverse the progression of stunting cannot be explained by differences between groups or inconsistencies in protocol implementation. These findings add to an emerging body of literature suggesting limited impact on stunting of interventions initiated during the period of complementary feeding in impoverished environments. The early onset and steady progression support the provision of earlier and comprehensive interventions. PMID:24399265

  3. Evaluating metal-organic frameworks for post-combustion carbon dioxide capture via temperature swing adsorption

    SciTech Connect

    Mason, JA; Sumida, K; Herm, ZR; Krishna, R; Long, JR

    2011-08-01

    Two representative metal-organic frameworks, Zn4O(BTB)(2)(BTB3- = 1,3,5-benzenetribenzoate; MOF-177) and Mg-2(dobdc) (dobdc(4-) = 1,4-dioxido-2,5-benzenedicarboxylate; Mg-MOF-74, CPO-27-Mg), are evaluated in detail for their potential use in post-combustion CO2 capture via temperature swing adsorption (TSA). Low-pressure single-component CO2 and N-2 adsorption isotherms were measured every 10 degrees C from 20 to 200 degrees C, allowing the performance of each material to be analyzed precisely. In order to gain a more complete understanding of the separation phenomena and the thermodynamics of CO2 adsorption, the isotherms were analyzed using a variety of methods. With regard to the isosteric heat of CO2 adsorption, Mg-2(dobdc) exhibits an abrupt drop at loadings approaching the saturation of the Mg2+ sites, which has significant implications for regeneration in different industrial applications. The CO2/N-2 selectivities were calculated using ideal adsorbed solution theory (IAST) for MOF-177, Mg-2(dobdc), and zeolite NaX, and working capacities were estimated using a simplified TSA model. Significantly, MOF-177 fails to exhibit a positive working capacity even at regeneration temperatures as high as 200 degrees C, while Mg-2(dobdc) reaches a working capacity of 17.6 wt% at this temperature. Breakthrough simulations were also performed for the three materials, demonstrating the superior performance of Mg-2(dobdc) over MOF-177 and zeolite NaX. These results show that the presence of strong CO2 adsorption sites is essential for a metal-organic framework to be of utility in post-combustion CO2 capture via a TSA process, and present a methodology for the evaluation of new metal-organic frameworks via analysis of single-component gas adsorption isotherms.

  4. Evaluation of a post-processing approach for multiscale analysis of biphasic mechanics of chondrocytes.

    PubMed

    Sibole, Scott C; Maas, Steve; Halloran, Jason P; Weiss, Jeffrey A; Erdemir, Ahmet

    2013-10-01

    Understanding the mechanical behaviour of chondrocytes as a result of cartilage tissue mechanics has significant implications for both evaluation of mechanobiological function and to elaborate on damage mechanisms. A common procedure for prediction of chondrocyte mechanics (and of cell mechanics in general) relies on a computational post-processing approach where tissue-level deformations drive cell-level models. Potential loss of information in this numerical coupling approach may cause erroneous cellular-scale results, particularly during multiphysics analysis of cartilage. The goal of this study was to evaluate the capacity of first- and second-order data passing to predict chondrocyte mechanics by analysing cartilage deformations obtained for varying complexity of loading scenarios. A tissue-scale model with a sub-region incorporating representation of chondron size and distribution served as control. The post-processing approach first required solution of a homogeneous tissue-level model, results of which were used to drive a separate cell-level model (same characteristics as the sub-region of control model). The first-order data passing appeared to be adequate for simplified loading of the cartilage and for a subset of cell deformation metrics, for example, change in aspect ratio. The second-order data passing scheme was more accurate, particularly when asymmetric permeability of the tissue boundaries was considered. Yet, the method exhibited limitations for predictions of instantaneous metrics related to the fluid phase, for example, mass exchange rate. Nonetheless, employing higher order data exchange schemes may be necessary to understand the biphasic mechanics of cells under lifelike tissue loading states for the whole time history of the simulation.

  5. Competence to stand trial evaluations of sovereign citizens: a case series and primer of odd political and legal beliefs.

    PubMed

    Parker, George F

    2014-01-01

    Sovereign citizens hold a variety of beliefs that challenge the legitimacy of the United States government and criminal justice system. In criminal cases, sovereign citizens typically raise a variety of seemingly strange objections to the proceedings that can cause court participants to believe the defendant is not competent to stand trial. The author's case files were reviewed to identify all defendants who espoused sovereign citizen beliefs during a court-ordered competence-to-stand-trial evaluation. This case series consisted of nine evaluations completed between 2003 and 2012. A review of the outcomes in these cases showed that sovereign citizens typically have the capacity to understand criminal proceedings and assist an attorney.

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

    PubMed

    Lwegaba, A

    2005-10-01

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

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

    PubMed Central

    2012-01-01

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

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

    PubMed Central

    2014-01-01

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

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

    PubMed Central

    Maggioni, Aldo P.; Greene, Stephen J.; Fonarow, Gregg C.; Böhm, Michael; Zannad, Faiez; Solomon, Scott D.; Lewis, Eldrin F.; Baschiera, Fabio; Hua, Tsushung A.; Gimpelewicz, Claudio R.; Lesogor, Anastasia; Gheorghiade, Mihai; Ramos, Silvina; Luna, Alejandra; Miriuka, Santiago; Diez, Mirta; Perna, Eduardo; Luquez, Hugo; Pinna, Jorge Garcia; Castagnino, Jorge; Alvarenga, Pablo; Ibañez, Julio; Blumberg, Eduardo Salmon; Dizeo, Claudio; Guerrero, Rodolfo Ahuad; Schygiel, Pablo; Milesi, Rodolfo; Sosa, Carlos; Hominal, Miguel; Marquez, Lilia Lobo; Poy, Carlos; Hasbani, Eduardo; Vico, Marisa; Fernandez, Alberto; Vita, Nestor; Vanhaecke, Johan; De Keulenaer, Gilles; Striekwold, Harry; Vervoort, Geert; Vrolix, Mathias; Henry, Philippe; Dendale, Paul; Smolders, Walter; Marechal, Patrick; Vandekerckhove, Hans; Oliveira, Mucio; Neuenschwande, Fernando; Reis, Gilmar; Saraiva, Jose; Bodanese, Luiz; Canesin, Manoel; Greco, Oswaldo; Bassan, Roberto; Marino, Roberto Luis; Giannetti, Nadia; Moe, Gordon; Sussex, Bruce; Sheppard, Richard; Huynh, Thao; Stewart, Robert; Haddad, Haissam; Echeverria, Luis; Quintero, Adalberto; Torres, Adriana; Jaramillo, Mónica; Lopez, Mónica; Mendoza, Fernan; Florez, Noel; Cotes, Carlos; Garcia, Magali; Belohlavek, Jan; Hradec, Jaromir; Peterka, Martin; Gregor, Pavel; Monhart, Zdenek; Jansky, Petr; Kettner, Jiri; Reichert, Petr; Spinar, Jindrich; Brabec, Tomas; Hutyra, Martin; Solar, Miroslav; Pietilä, Mikko; Nyman, Kai; Pajari, Risto; Cohen, Ariel; Galinier, Michel; Gosse, Philippe; Livarek, Bernard; Neuder, Yannick; Jourdain, Patrick; Picard, François; Isnard, Richard; Hoppe, Uta; Kaeaeb, Stefan; Rosocha, Stefan; Prondzinsky, Roland; Felix, Stephan; Duengen, Hans-Dirk; Figulla, Hans-Reiner; Fischer, Sven; Behrens, Steffen; Stawowy, Philipp; Kruells-Muench, Juergen; Knebel, Fabian; Nienaber, Christoph; Werner, Dierk; Aron, Wilma; Remppis, Bjoern; Hambrecht, Rainer; Kisters, Klaus; Werner, Nikos; Hoffmann, Stefan; Rossol, Siegbert; Geiss, Ernst; Graf, Kristof; Hamann, Frank; von Scheidt, Wolfgang; Schwinger, Robert; Tebbe, Ulrich; Costard-Jaeckle, Angelika; Lueders, Stephan; Heitzer, Thomas; Leutermann-Oei, Marie-Louise; Braun-Dullaeus, Ruediger; Roehnisch, Jens-Uwe; Muth, Gerhard; Goette, Andreas; Rotter, Achim; Ebelt, Henning; Olbrich, Hans-Georg; Mitrovic, Veselin; Hengstenberg, Christian; Schellong, Sebastian; Zamolyi, Karoly; Vertes, Andras; Matoltsy, Andras; Palinkas, Attila; Herczeg, Bela; Apro, Dezso; Lupkovics, Geza; Tomcsanyi, Janos; Toth, Kalman; Mathur, Atul; Banker, Darshan; Bharani, Anil; Arneja, Jaspal; Khan, Aziz; Gadkari, Milind; Hiremath, Jagdish; Patki, Nitin; Kumbla, Makund; Santosh, M.J.; Ravikishore, A.G.; Abhaichand, Rajpal; Maniyal, Vijayakukmar; Nanjappa, Manjunath; Reddy, P. Naveen; Chockalingam, Kulasekaran; Premchand, Rajendra; Mahajan, Vijay; Lewis, Basil; Wexler, Dov; Shochat, Michael; Keren, Andre; Omary, Muhamad; Katz, Amos; Marmor, Alon; Lembo, Giuseppe; Di Somma, Salvatore; Boccanelli, Alessandro; Barbiero, Mario; Pajes, Giuseppe; De Servi, Stefano; Greco, Dott Cosimo; De Santis, Fernando; Floresta, Agata; Visconti, Luigi Oltrona; Piovaccari, Giancarlo; Cavallini, Claudio; Di Biase, Matteo; Masini, Dott Franco; Vassanelli, Corrado; Viecca, Maurizio; Cangemi, Dott Francesco; Pirelli, Salvatore; Borghi, Claudio; Volpe, Massimo; Branzi, Angelo; Percoco, Dott Giovanni; Severi, Silvia; Santini, Alberto; De Lorenzi, Ettore; Metra, Marco; Zacà, Valerio; Mortara, Andrea; Tranquilino, Francisco P.; Babilonia, Noe A.; Ferrolino, Arthur M.; Manlutac, Benjamin; Dluzniewski, Miroslaw; Dzielinska, Zofia; Nowalany-Kozie, Ewa; Mazurek, Walentyna; Wierzchowiecki, Jerzy; Wysokinski, Andrzej; Szachniewicz, Joanna; Romanowski, Witold; Krauze-Wielicka, Magdalena; Jankowski, Piotr; Berkowski, Piotr; Szelemej, Roman; Kleinrok, Andrzej; Kornacewicz-Jac, Zdzislawa; Vintila, Marius; Vladoianu, Mircea; Militaru, Constantin; Dan, Gheorghe; Dorobantu, Maria; Dragulescu, Stefan; Kostenko, Victor; Vishnevsky, Alexandr; Goloschekin, Boris; Tyrenko, Vadim; Gordienko, Alexander; Kislyak, Oxana; Martsevich, Sergey; Kuchmin, Alexey; Karpov, Yurii; Fomin, Igor; Shvarts, Yury; Orlikova, Olga; Ershova, Olga; Berkovich, Olga; Sitnikova, Maria; Pakhomova, Inna; Boldueva, Svetlana; Tyurina, Tatiana; Simanenkov, Vladimir; Boyarkin, Mikhail; Novikova, Nina; Tereschenko, Sergey; Zadionchenko, Vladimir; Shogenov, Zaur; Gordeev, Ivan; Moiseev, Valentin; Wong, Raymond; Ong, Hean Yee; Le Tan, Ju; Goncalvesova, Eva; Kovar, Frantisek; Skalina, Ivan; Kasperova, Viera; Hojerova, Silvia; Szentivanyi, Miroslav; Stancak, Branislav; Babcak, Marian; Kycina, Peter; Poliacik, Pavol; Toth, Peter; Sirotiakova, Jana; de Sa, Esteban Lopez; Bueno, Manuel Gomez; Selles, Manuel Martinez; Cabrera, Jose Angel; Freire, Ramon Bover; Gonzalez Juanatey, Jose Ramon; Comin, Josep; Soriano, FranciscoRidocci; Lopez, Alejandro; Vicho, Raul; Lama, Manuel Geraldia; Schaufelberger, Maria; Brunotte, Richard; Ullman, Bengt; Hagerman, Inger; Cizinsky, Stella; Cherng, Wen-Jin; Yu, Wen-Chung; Kuo, Chi-Tai; Chang, Kuan-Cheng; Lai, Wen-Ter; Kuo, Jen-Yuan; Ural, Dilek; Badak, Ozer; Akin, Mustafa; Yigit, Zerrin; Yokusoglu, Mehmet; Yilmaz, Mehmet; Abaci, Adnan; Ebinc, Haksun; Perlman, Richard; Parish, David; Bergin, James; Burnham, Kenneth; Brown, Christopher; Lundbye, Justin; Williams, Celeste; Eisen, Howard; Juneman, Elizabeth; Joseph, Susan; Peberdy, Mary Ann; Peura, Jennifer; Gupta, Vishal; Habet, Kalim; French, William; Mody, Freny; Graham, Susan; Hazelrigg, Monica; Chung, Eugene; Dunlap, Stephanie; Nikolaidis, Lazaros; Najjar, Samer; Katz, Richard; Murali, Srinivas; Izzo, Joseph L.; Callister, Tracy; Phillips, Roland; Lippolis, Nicholas; Winterton, John; Meymandi, Sheba; Heilman, Karl; Oren, Ron; Zolty, Ronald; Brottman, Michael; Gunawardena, D.R.; Adams, Kirkwood; Barnard, Denise; Klapholz, Marc; Fulmer, James

    2013-01-01

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

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

    PubMed

    Midilli, Tulay Sagkal; Eser, Ismet

    2015-06-01

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

  11. Process evaluation of the Data-driven Quality Improvement in Primary Care (DQIP) trial: case study evaluation of adoption and maintenance of a complex intervention to reduce high-risk primary care prescribing

    PubMed Central

    Dreischulte, Tobias; Guthrie, Bruce

    2017-01-01

    Objective To explore how different practices responded to the Data-driven Quality Improvement in Primary Care (DQIP) intervention in terms of their adoption of the work, reorganisation to deliver the intended change in care to patients, and whether implementation was sustained over time. Design Mixed-methods parallel process evaluation of a cluster trial, reporting the comparative case study of purposively selected practices. Setting Ten (30%) primary care practices participating in the trial from Scotland, UK. Results Four practices were sampled because they had large rapid reductions in targeted prescribing. They all had internal agreement that the topic mattered, made early plans to implement including assigning responsibility for work and regularly evaluated progress. However, how they internally organised the work varied. Six practices were sampled because they had initial implementation failure. Implementation failure occurred at different stages depending on practice context, including internal disagreement about whether the work was worthwhile, and intention but lack of capacity to implement or sustain implementation due to unfilled posts or sickness. Practice context was not fixed, and most practices with initial failed implementation adapted to deliver at least some elements. All interviewed participants valued the intervention because it was an innovative way to address on an important aspect of safety (although one of the non-interviewed general practitioners in one practice disagreed with this). Participants felt that reviewing existing prescribing did influence their future initiation of targeted drugs, but raised concerns about sustainability. Conclusions Variation in implementation and effectiveness was associated with differences in how practices valued, engaged with and sustained the work required. Initial implementation failure varied with practice context, but was not static, with most practices at least partially implementing by the end of the

  12. Evaluating the implementation of a school-based emotional well-being programme: a cluster randomized controlled trial of Zippy's Friends for children in disadvantaged primary schools.

    PubMed

    Clarke, Aleisha M; Bunting, Brendan; Barry, Margaret M

    2014-10-01

    Schools are recognized as one of the most important settings for promoting social and emotional well-being among children and adolescents. This clustered randomized controlled trial evaluated Zippy's Friends, an international school-based emotional well-being programme, with 766 children from designated disadvantaged schools. The purpose of this study was to evaluate the immediate and long term impact of the programme and to determine the impact of implementation fidelity on programme outcomes. Teachers reported emotional literacy outcomes using the Emotional Literacy Checklist, and emotional and behavioural outcomes using the Strengths and Difficulties Questionnaire. Controlling for the hierarchical structure of the data, path analysis using structural equation modelling revealed that the programme had a significant positive impact on the children's emotional literacy scores including significant improvements in the subscale scores of self-awareness (P < 0.001), self-regulation (P < 0.01), motivation (P < 0.001) and social skills (P < 0.001) at post-intervention. These results were maintained at 12-month follow-up (P < 0.01). The programme, however, did not have a significant impact on children's emotional and behavioural problems. Analysis of programme fidelity indicated that high fidelity was directly related to improved emotional literacy scores at post-intervention.

  13. Evaluating a Website to Teach Children Safety with Dogs: A Randomized Controlled Trial

    PubMed Central

    Schwebel, David C.; Li, Peng; McClure, Leslie A.; Severson, Joan

    2016-01-01

    Dog bites represent a significant threat to child health. Theory-driven interventions scalable for broad dissemination are sparse. A website was developed to teach children dog safety via increased knowledge, improved cognitive skills in relevant domains, and increased perception of vulnerability to bites. A randomized controlled trial was conducted with 69 children aged 4–5 randomly assigned to use the dog safety website or a control transportation safety website for ~3 weeks. Assessment of dog safety knowledge and behavior plus skill in three relevant cognitive constructs (impulse control, noticing details, and perspective-taking) was conducted both at baseline and following website use. The dog safety website incorporated interactive games, instructional videos including testimonials, a motivational rewards system, and messaging to parents concerning child lessons. Our results showed that about two-thirds of the intervention sample was not adherent to website use at home, so both intent-to-treat and per-protocol analyses were conducted. Intent-to-treat analyses yielded mostly null results. Per-protocol analyses suggested children compliant to the intervention protocol scored higher on knowledge and recognition of safe behavior with dogs following the intervention compared to the control group. Adherent children also had improved scores post-intervention on the cognitive skill of noticing details compared to the control group. We concluded that young children’s immature cognition can lead to dog bites. Interactive eHealth training on websites shows potential to teach children relevant cognitive and safety skills to reduce risk. Compliance to website use is a challenge, and some relevant cognitive skills (e.g., noticing details) may be more amenable to computer-based training than others (e.g., impulse control). PMID:27918466

  14. Evaluating a Website to Teach Children Safety with Dogs: A Randomized Controlled Trial.

    PubMed

    Schwebel, David C; Li, Peng; McClure, Leslie A; Severson, Joan

    2016-12-02

    Dog bites represent a significant threat to child health. Theory-driven interventions scalable for broad dissemination are sparse. A website was developed to teach children dog safety via increased knowledge, improved cognitive skills in relevant domains, and increased perception of vulnerability to bites. A randomized controlled trial was conducted with 69 children aged 4-5 randomly assigned to use the dog safety website or a control transportation safety website for ~3 weeks. Assessment of dog safety knowledge and behavior plus skill in three relevant cognitive constructs (impulse control, noticing details, and perspective-taking) was conducted both at baseline and following website use. The dog safety website incorporated interactive games, instructional videos including testimonials, a motivational rewards system, and messaging to parents concerning child lessons. Our results showed that about two-thirds of the intervention sample was not adherent to website use at home, so both intent-to-treat and per-protocol analyses were conducted. Intent-to-treat analyses yielded mostly null results. Per-protocol analyses suggested children compliant to the intervention protocol scored higher on knowledge and recognition of safe behavior with dogs following the intervention compared to the control group. Adherent children also had improved scores post-intervention on the cognitive skill of noticing details compared to the control group. We concluded that young children's immature cognition can lead to dog bites. Interactive eHealth training on websites shows potential to teach children relevant cognitive and safety skills to reduce risk. Compliance to website use is a challenge, and some relevant cognitive skills (e.g., noticing details) may be more amenable to computer-based training than others (e.g., impulse control).

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

    SciTech Connect

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

    2004-09-01

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

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

    PubMed Central

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

    2014-01-01

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

  17. Results of a prospective multicenter trial evaluating the ePTFE peritoneal onlay laparoscopic inguinal hernioplasty.

    PubMed

    Toy, F K; Moskowitz, M; Smoot, R T; Pleatman, M; Bagdasarian, A; Polito, W; Carey, S D; Schatz, R; Janes, K; Zipser, M E

    1996-12-01

    A 2.8-year prospective multicenter trial was conducted to evaluate the ePTFE peritoneal onlay laparoscopic inguinal hernioplasty. A total of 441 inguinal hernias were repaired in 351 patients (326 male; 25 female). Two hundred twenty-six of the hernias were direct, 185 indirect, 4 femoral, 26 pantaloon, 90 bilateral, and 92 recurrent. Standardized data collection forms were used and submitted for centralized data analysis. For the hernioplasty, Cooper's ligament was exposed and an 8 cm x 12 cm x 1 mm GORE-TEX Soft Tissue Patch was stapled circumferentially to Cooper's ligament and the endoabdominal fascia. Patients were followed at 1 week, 6 months, 1 year, and then annually. Three-month intervals were used as needed. There was a mean follow-up of 447 days, with 21% of the total repairs followed for more than 2 years and 56% for more than a year. The overall follow-up rate was 95.5%. The operative and postoperative complication rates were 0.45% and 8%, respectively. There were 17 recurrent hernias (3.8%). The range of experience among the investigators was 13 to 168 hernioplasties. With the completion of 25 cases per investigator, the recurrence rate fell to 0.39%. Postoperative analgesia averaged a 24-hr supply of medication; 12.2% of patients required no analgesia. Convalescence averaged 5.4 days, and return to work averaged 7.7 days. This multicenter trial demonstrates that the ePTFE laparoscopic peritoneal onlay inguinal hernioplasty is a safe and dependable repair, especially after the initial learning curve is surmounted.

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

    SciTech Connect

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

    2013-11-01

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

  19. Effect of Citalopram in Combination with Omega-3 on Depression in Post-menopausal Women: A Triple Blind Randomized Controlled Trial

    PubMed Central

    Masoumi, Seyedeh Zahra; Kazemi, Farideh; Rahimi, Alireza; Oshvandi, Khodayar; Soltanian, Alireza; Shobeiri, Fatemeh

    2016-01-01

    Introduction Depressive disorder is a common and disabling disorder that causes high rates of morbidity and mortality. Citalopram is an antidepressant drug, of the Selective Serotonin Reuptake Inhibitor (SSRI) class that has been used for geriatric depression since a long time ago. Prescription of omega-3 in geriatric depression has been increased recently; because of more favorable profile of their side effects. Some of the studies reported that omega-3 is effective in prevention or treatment of depressive disorders than Citalopram. However, there are contradictory studies too. Aim This study aimed to investigate the effect of a combination of omega-3 and citalopram in the treatment of women with post-menopausal depression. Materials and Methods This triple-blind randomized controlled trial was conducted on 60 women with post-menopausal depression who were referred to the Hamadan Fatemieh Hospital. After the participants completed the DSM-IV questionnaire and depression was confirmed by a psychiatrist, participants were assigned randomly into two-intervention and control groups. The patients in the control group received 20mg citalopram along with a placebo while patients in the intervention group received 20mg citalopram and 1g of omega-3. At baseline and at the end of the first, second, and fourth weeks, all of the participants answered the Beck’s Depression Inventory (BDI). Descriptive statistics and t-test, repeated measures analysis of variance and Bonferroni post-hoc test was used to analyse the data. Results The depression score was 6.1±2.41 in intervention and 25.22±10.04 in control group, four weeks after intervention. A decreasing trend was observed in the mean depression scores of the intervention group during the study. Using repeated measures analysis of variance, a significant difference was observed between the mean depression scores of the two groups at the four measurement time-points (p<0.001). The mean depression scores of the intervention

  20. Washing red blood cells and platelets transfused in cardiac surgery reduces post-operative inflammation and number of transfusions: Results of a prospective, randomized, controlled clinical trial

    PubMed Central

    Cholette, Jill M; Henrichs, Kelly F; Alfieris, George M; Powers, Karen S.; Phipps, Richard; Spinelli, Sherry L.; Swartz, Michael; Gensini, Francisco; Daugherty, L. Eugene; Nazarian, Emily; Rubenstein, Jeffrey S.; Sweeney, Dawn; Eaton, Michael; Lerner, Norma B; Blumberg, Neil

    2013-01-01

    Objective Children undergoing cardiac surgery with cardiopulmonary bypass (CPB) are susceptible to additional inflammatory and immunogenic insults from blood transfusions. We hypothesize that washing red blood cells (RBC) and platelets transfused to these patients will reduce post-operative transfusion-related immune modulation and inflammation. Design Prospective randomized controlled clinical trial. Setting University hospital pediatric cardiac intensive care unit. Patients Children from birth to 17 years old undergoing cardiac surgery with CPB. Interventions Children were randomized to an unwashed or washed RBC and platelet transfusion protocol for their surgery and postoperative care. All blood was leukoreduced, irradiated, and ABO identical. Plasma was obtained for laboratory analysis: pre-op, immediately, six and 12 hours after CPB. Primary outcome was the 12-hour post-CPB interleukin (IL)-6: IL-10 ratio. Secondary measures were IL levels, C-reactive protein (CRP), and clinical outcomes. Measurements and main results 162 subjects were studied, 81 per group. 34 subjects (17 per group) did not receive any blood transfusions. Storage duration of blood products was similar between groups. Among transfused subjects, the 12-hour IL ratio was significantly lower in the washed group (3.8 v. 4.8; p=0.04) secondary to lower IL-6 levels (post-CPB: 65 v.100 pg/ml; p = 0.06; 6 hour: 89 v.152 pg/ml; p = 0.02; 12-hour: 84 v.122 pg/ml; p = 0.09). Post-operative CRP was lower in subjects receiving washed blood (38 v. 43 mg/L; p = 0.03). There was a numerical, but not statistically significant decrease in total blood product transfusions (203 v. 260) and mortality (2 v. 6 deaths) in the washed group compared to the unwashed group. Conclusions Washed blood transfusions in cardiac surgery reduced inflammatory biomarkers, number of transfusions, donor exposures, and were associated with a non-significant trend towards reduced mortality. A larger study powered to test for clinical

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

    SciTech Connect

    Connie Lyons; Richard Current; Terry Ackman

    1998-09-16

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

  2. Evaluation of Pre- and Post- Redevelopment Groundwater Chemical Analyses from LM Monitoring Wells

    SciTech Connect

    Kamp, Susan; Dayvault, Jalena

    2016-05-01

    This report documents the efforts and analyses conducted for the Applied Studies and Technology (AS&T) Ancillary Work Plan (AWP) project titled Evaluation of Pre- and Post- Redevelopment Groundwater Sample Laboratory Analyses from Selected LM Groundwater Monitoring Wells. This effort entailed compiling an inventory of nearly 500 previous well redevelopment events at 16 U.S. Department of Energy Office of Legacy Management (LM) sites, searching the literature for impacts of well redevelopment on groundwater sample quality, and—the focus of this report—evaluating the impacts of well redevelopment on field measurements and sample analytical results. Study Catalyst Monitoring well redevelopment, the surging or high-volume pumping of a well to loosen and remove accumulated sediment and biological build-up from a well, is considered an element of monitoring well maintenance that is implemented periodically during the lifetime of the well to mitigate its gradual deterioration. Well redevelopment has been conducted fairly routinely at a few LM sites in the western United States (e.g., the Grand Junction office site and the Gunnison processing site in Colorado), but at most other sites in this region it is not a routine practice. Also, until recently (2014–2015), there had been no specific criteria for implementing well redevelopment, and documentation of redevelopment events has been inconsistent. A catalyst for this evaluation was the self-identification of these inconsistencies by the Legacy Management Support contractor. As a result, in early 2015 Environmental Monitoring Operations (EMO) staff began collecting and documenting additional field measurements during well redevelopment events. In late 2015, AS&T staff undertook an independent internal evaluation of EMO's well redevelopment records and corresponding pre- and post-well-redevelopment groundwater analytical results. Study Findings Although literature discussions parallel the prevailing industry

  3. Evaluation of Motor Performances of Hemiplegic Patients Using a Virtual Cycling Wheelchair: An Exploratory Trial

    PubMed Central

    Yoshizawa, Makoto; Kojima, Yoshihisa; Abe, Makoto; Seki, Kazunori; Handa, Nobuyasu

    2013-01-01

    Cycling is known to be an effective rehabilitation exercise for hemiplegic patients who face difficulty during walking because of stroke or other brain disorders. A cycling wheelchair (CWC) is a useful tool to provide exercise for these patients and improve their quality of life. In previous studies, our group developed a system that allows patients to safely practice driving a CWC in a virtual environment. However, it has been difficult to check their motor performances and determine the effects of the exercise on a daily basis. This study is an exploratory trial for developing a method to evaluate the motor performances of users based on their CWC pedaling patterns. An experiment with some hemiplegic patients and healthy subjects was conducted and their pedaling patterns were analyzed. Results showed a significant difference between the hemiplegic patients and healthy subjects in an index that reflects pedaling balance between the feet. This result indicates a possible method of evaluating the motor performances of users based on their pedaling patterns. PMID:24371469

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

    PubMed Central

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

    2015-01-01

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

  5. A Comparative Evaluation of the Retention of Tooth Coloured and Stainless Steel Endodontic Posts: An In-vitro Study

    PubMed Central

    Maria, Rahul; Punga, Rohit

    2014-01-01

    Aims: This in vitro study evaluated: a) the retention of stainless steel posts of 1.5 mm diameter which were cemented with Zinc Phosphate cement versus Glass fiber posts with 1.1 mm, 1.3 mm and 1.5 mm diameters which were cemented with resin cement and b) the effect of change in diameter on the retention of Glass fiber posts with 1.1 mm, 1.3 mm and 1.5 mm diameters. Materials and Methods: Sixty extracted mandibular premolar teeth were endodontically treated and randomly assigned to four groups of fifteen teeth each. In Groups I, II and III glass fibre posts with diameters 1.1 mm, 1.3 mm and 1.5 mm were cemented by using resin cement. In Group IV, stainless steel posts with diameter 1.5 mm were cemented by using zinc phosphate cement. The specimens were tested for tensile loading at a cross head speed of 2.0 mm/min, on a universal testing machine. Statistical Analysis Used: One way analysis of variance and Tukey’s (post-hoc) test. Results: Mean tensile strength from highest to lowest was in the order of Group IV, Group II, Group III, Group I. Statistically significant differences were observed between the mean tensile strengths between Groups I and II, Groups I and III, Groups I and IV, Groups II and IV, Groups III and IV, while non significant differences were observed between Groups II and III. Conclusion: Stainless steel posts were more retentive than glass fibre posts. Glass fibre posts with 1.3 mm or 1.5 mm diameters provided significantly greater retention as compared to 1.1 mm diameter posts. PMID:24959506

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

    PubMed Central

    2014-01-01

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

  7. Efficacy and Safety of Risedronate in Osteoporosis Subjects with Comorbid Diabetes, Hypertension, and/or Dyslipidemia: A Post Hoc Analysis of Phase III Trials Conducted in Japan.

    PubMed

    Inoue, Daisuke; Muraoka, Ryoichi; Okazaki, Ryo; Nishizawa, Yoshiki; Sugimoto, Toshitsugu

    2016-02-01

    Many osteoporotics have comorbid diabetes mellitus (DM), hypertension (HT), and dyslipidemia (DL). However, whether such comorbidities alter response to anti-osteoporotic treatment is unknown. We did post hoc analyses of combined data from three risedronate Japanese phase III trials to determine whether the presence of DM, HT, or DL affects its efficacy and safety. Data from 885 subjects who received 48-week treatment with risedronate were collected and combined from the three phase III trials. They were divided into two groups by the presence or absence of comorbidities: DM (n = 53) versus non-DM (n = 832); HT (n = 278) versus non-HT (n = 607); and DL (n = 292) versus non-DL (n = 593). Bone mineral density (BMD), urinary type 1 collagen N-telopeptide (uNTX), and serum bone-specific alkaline phosphatase (BAP) were measured at baseline and sequentially until 48 weeks. BMD or bone markers were not different between any of the two groups. Overall, BMD was increased by 5.52%, and uNTX and BAP were decreased by 35.4 and 33.8%, respectively. Some bone markers were slightly lower in DM and DL subjects, but the responses to risedronate were not significantly different. Statin users had lower uNTX and BAP, but showed no difference in the treatment response. All the other medications had no apparent effect. Adverse event incidence was marginally higher in DL compared with non-DL (Relative risk 1.06; 95% confidence interval 1.01-1.11), but was not related to increase in any specific events. Risedronate shows consistent safety and efficacy in suppressing bone turnover and increasing BMD in osteoporosis patients with comorbid DM, HT, and/or DL.

  8. Evaluation of a Self-Instructional Package on Discrete-Trials Teaching to Parents of Children with Autism

    ERIC Educational Resources Information Center

    Young, Kristen L.; Boris, Ashley L.; Thomson, Kendra M.; Martin, Garry L.; Yu, C. T.

    2012-01-01

    The purpose of this research was to evaluate a self-instructional package (Fazzio & Martin, 2007) to train parents of children with autism to conduct discrete-trials teaching (DTT). In Study 1, we investigated the effectiveness of a self-instructional manual and a self-instructional video for teaching five parents of children with autism to…

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    ERIC Educational Resources Information Center

    Richburg, Robert; And Others

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

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

    ERIC Educational Resources Information Center

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

    2015-01-01

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

  12. Method for evaluation of predictive models of microwave ablation via post-procedural clinical imaging

    NASA Astrophysics Data System (ADS)

    Collins, Jarrod A.; Brown, Daniel; Kingham, T. Peter; Jarnagin, William R.; Miga, Michael I.; Clements, Logan W.

    2015-03-01

    Development of a clinically accurate predictive model of microwave ablation (MWA) procedures would represent a significant advancement and facilitate an implementation of patient-specific treatment planning to achieve optimal probe placement and ablation outcomes. While studies have been performed to evaluate predictive models of MWA, the ability to quantify the performance of predictive models via clinical data has been limited to comparing geometric measurements of the predicted and actual ablation zones. The accuracy of placement, as determined by the degree of spatial overlap between ablation zones, has not been achieved. In order to overcome this limitation, a method of evaluation is proposed where the actual location of the MWA antenna is tracked and recorded during the procedure via a surgical navigation system. Predictive models of the MWA are then computed using the known position of the antenna within the preoperative image space. Two different predictive MWA models were used for the preliminary evaluation of the proposed method: (1) a geometric model based on the labeling associated with the ablation antenna and (2) a 3-D finite element method based computational model of MWA using COMSOL. Given the follow-up tomographic images that are acquired at approximately 30 days after the procedure, a 3-D surface model of the necrotic zone was generated to represent the true ablation zone. A quantification of the overlap between the predicted ablation zones and the true ablation zone was performed after a rigid registration was computed between the pre- and post-procedural tomograms. While both model show significant overlap with the true ablation zone, these preliminary results suggest a slightly higher degree of overlap with the geometric model.

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

    PubMed Central

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

    2015-01-01

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

  14. Effect of Dexamethasone Intraligamentary Injection on Post-Endodontic Pain in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Clinical Trial

    PubMed Central

    Mehrvarzfar, Payman; Esnashari, Ehsan; Salmanzadeh, Reyhaneh; Fazlyab, Mahta; Fazlyab, Mahyar

    2016-01-01

    Introduction: The aim of this randomized-controlled clinical trial was to assess the effect of intraligamentary (PDL) injection of dexamethasone on onset and severity of post-treatment pain in patients with symptomatic irreversible pulpitis. Methods and Materials: A total number of 60 volunteers were included according to the inclusion criteria and were assigned to three groups (n=20). After administration of local anesthesia and before treatment, group 1 (control) PDL injection was done with syringe containing empty cartridge, while in groups 2 and 3 the PDL injection was done with 0.2 mL of 2% lidocaine or dexamethasone (8 mg/2 mL), respectively. Immediately after endodontic treatment patients were requested to mark their level of pain on a visual analogue scale (VAS) during the next 48 h (on 6, 12, 24 and 48-h intervals). They were also asked to mention whether analgesics were taken and its dosage. Considering the 0-170 markings on the VAS ruler, the level of pain was scored as follows: score 0 (mild pain; 0-56), score 1 (moderate pain; 57-113) and score 3 (severe pain; 114-170). The data were analyzed using the Kruskal-Wallis and the Chi-square tests and the level of significance was set at 0.05. Results: After 6 and 12 h, group 1 and group 3 had the highest and lowest pain values, respectively (P<0.01 and P<0.001 for 6 and 12 h, respectively). However, after 24 and 48 h the difference in the pain was not significant between groups 1 and 2 (P<0.6) but group 3 had lower pain levels (P<0.01 and P<0.8 for 24 and 48 h, respectively). Conclusion: Pretreatment PDL injection of dexamethasone can significantly reduce the post-treatment endodontic pain in patients with symptomatic irreversible pulpitis. PMID:27790253

  15. A cost effectiveness analysis within a randomised controlled trial of post-acute care of older people in a community hospital

    PubMed Central

    O'Reilly, Jacqueline; Lowson, Karin; Young, John; Forster, Anne; Green, John; Small, Neil

    2006-01-01

    Objective To assess the cost effectiveness of post-acute care for older people in a locality based community hospital compared with a department for care of elderly people in a district general hospital, which admits patients aged over 76 years with acute medical conditions. Design Cost effectiveness analysis within a randomised controlled trial. Setting Community hospital and district general hospital in Yorkshire, England. Participants 220 patients needing rehabilitation after an acute illness for which they required admission to hospital. Interventions Multidisciplinary care in the district general hospital or prompt transfer to the community hospital. Main outcome measures EuroQol EQ-5D scores transformed into quality adjusted life years (QALYs), and health and social service costs over six months from randomisation. Results The mean QALY score for the community hospital group was marginally non-significantly higher than that for the district general hospital group (0.38 v 0.35) at six months after recruitment. The mean (standard deviation) costs per patient of the health and social services resources used were similar for both groups: community hospital group £7233 (euros 10 567; $13 341) (£5031), district general hospital group £7351 (£6229), and these findings were robust to several sensitivity analyses. The incremental cost effectiveness ratio for community hospital care dominated. A cost effectiveness acceptability curve, based on bootstrapped simulations, suggests that at a willingness to pay threshold of £10 000 per QALY, 51% of community hospital cases will be cost effective, which rises to 53% of cases when the threshold is £30 000 per QALY. Conclusion Post-acute care for older people in a locality based community hospital is of similar cost effectiveness to that of an elderly care department in a district general hospital. PMID:16861254

  16. SBOTE study: extracorporeal shock wave therapy versus electrical stimulation after botulinum toxin type a injection for post-stroke spasticity-a prospective randomized trial.

    PubMed

    Santamato, Andrea; Notarnicola, Angela; Panza, Francesco; Ranieri, Maurizio; Micello, Maria Francesca; Manganotti, Paolo; Moretti, Biagio; Fortunato, Francesca; Filoni, Serena; Fiore, Pietro

    2013-02-01

    Research is on-going to identify new methods of biostimulation to increase the effect of botulinum toxin type A (BTX-A) in the treatment of spasticity. The Spasticity treated by Botulinum Toxin and ESWT (SBOTE) study is a prospective, randomized controlled trial assessing the effectiveness of extracorporeal shock wave therapy (ESWT) given immediately after BTX-A injections compared with electrical stimulation (ES) given immediately after BTX-A therapy for the management of focal upper limb spasticity in stroke patients. ES was given for 30 min twice a day for 5 days starting at 5 Hz; ESWT was given once a day for 5 days. At study follow-up, patients treated with BTX-A injections and ESWT showed a statistically greater significance and continuous decrease of spasticity measure (modified Ashworth scale [MAS]: 1.37, 1.75 and 1.58 at 15, 30 and 90 days post-treatment, respectively), of spasms (spasm frequency scale [SFS]: 0.8 and 0.25 at 30 and 90 days post-treatment, respectively) and of pain (visual analogue scale [VAS]: 1.94 and 1.87 at 30 and 90 days, respectively) compared with patients treated with BTX-A injections and ES (MAS: 2.37, 2.18 and 2.18, respectively) (p < 0.05) (SFS: 1.5 and 1.06, respectively) (p < 0.05) (VAS: 2.44 and 2.69 respectively) (p < 0.05). ESWT enhances the effect of BTX-A to a greater extent than ES, probably by modulating rheology of the muscle and neurotransmission at the neuromuscular junction.

  17. Preliminary evaluation of PTSD Coach, a smartphone app for post-traumatic stress symptoms.

    PubMed

    Kuhn, Eric; Greene, Carolyn; Hoffman, Julia; Nguyen, Tam; Wald, Laura; Schmidt, Janet; Ramsey, Kelly M; Ruzek, Josef

    2014-01-01

    PTSD Coach is a mobile application (app) designed to help individuals who have post-traumatic stress disorder (PTSD) symptoms better understand and self-manage their symptoms. It has wide-scale use (over 130,000 downloads in 78 countries) and very favorable reviews but has yet to be evaluated. Therefore, this study examines user satisfaction, perceived helpfulness, and usage patterns of PTSD Coach in a sample of 45 veterans receiving PTSD treatment. After using PTSD Coach for several days, participants completed a survey of satisfaction and perceived helpfulness and focus groups exploring app use and benefit from use. Data indicate that participants were very satisfied with PTSD Coach and perceived it as being moderately to very helpful with their PTSD symptoms. Analysis of focus group data resulted in several categories of app use: to manage acute distress and PTSD symptoms, at scheduled times, and to help with sleep. These findings offer preliminary support for the acceptability and perceived helpfulness of PTSD Coach and suggest that it has potential to be an effective self-management tool for PTSD. Although promising, future research is required to validate this, given study limitations.

  18. Evaluation of cation-exchanged zeolite adsorbents for post-combustion carbon dioxide capture

    SciTech Connect

    Bae, TH; Hudson, MR; Mason, JA; Queen, WL; Dutton, JJ; Sumida, K; Micklash, KJ; Kaye, SS; Brown, CM; Long, JR

    2013-01-01

    A series of zeolite adsorbents has been evaluated for potential application in post-combustion CO2 capture using a new high-throughput gas adsorption instrument capable of measuring 28 samples in parallel. Among the zeolites tested, Ca-A exhibits the highest CO2 uptake (3.72 mmol g(-1) and 5.63 mmol cm(-3)) together with an excellent CO2 selectivity over N-2 under conditions relevant to capture from the dry flue gas stream of a coal-fired power plant. The large initial isosteric heat of adsorption of -58 kJ mol(-1) indicates the presence of strong interactions between CO2 and the Ca-A framework. Neutron and X-ray powder diffraction studies reveal the precise location of the adsorption sites for CO2 in Ca-A and Mg-A. A detailed study of CO2 adsorption kinetics further shows that the performance of Ca-A is not limited by slow CO2 diffusion within the pores. Significantly, Ca-A exhibited a higher volumetric CO2 uptake and CO2/N-2 selectivity than Mg-2(dobdc) (dobdc(4-) = 1,4-dioxido-2,5-benzenedicarboxylate; Mg-MOF-74, CPO-27-Mg), one of the best performing adsorbents. The exceptional performance of Ca-A was maintained in CO2 breakthrough simulations.

  19. Sonographic Evaluation of Structural Changes in Post-Stroke Hemiplegic Shoulders

    PubMed Central

    Idowu, Bukunmi Michael; Ayoola, Oluwagbemiga Oluwole; Adetiloye, Victor Adebayo; Komolafe, Morenikeji Adeyoyin

    2017-01-01

    Summary Background Stroke and hemiplegia are frequent complications of stroke. This study was performed to sonographically evaluate post-stroke hemiplegic shoulders and explore possible relationship(s) between the sonographic findings and clinical indices. Material/Methods Forty-five stroke patients and 45 age- and sex-matched controls were recruited. Standard sonographic examination of both shoulders was performed to assess for joint subluxation, rotator cuff tears, tendinosis, subacromial-subdeltoid bursitis or effusion and adhesive capsulitis. Results Hemiplegic shoulders exhibited significantly higher number of pathologies compared to the unaffected shoulders and shoulders of controls (p=0.000). One or more structural abnormalities were found in all 45 (100%) hemiplegic shoulders, 25 (55.6%) unaffected shoulders of the stroke subjects, and 39 (43.3%) control shoulders. The most frequent pathologies in the hemiplegic shoulders were the following: tendinosis of the long head of bicep tendon (48.9%), inferior shoulder subluxation (44.4%), co-existing subacromial-subdeltoid bursa/long head of bicep tendon sheath effusion (44.4%), and long head of bicep tendon sheath effusion only (40%). Tendinosis of the long head of bicep tendon was commoner in hemiplegic shoulders with poor motor status than those with good motor status. Conclusions Hemiplegic shoulders have significantly higher number of structural abnormalities than unaffected shoulders and the shoulders of controls. Hemiplegic stroke patients should undergo ultrasonography of the hemiplegic shoulder to define the nature and extent of soft tissue injuries prior to physical therapy. PMID:28382186

  20. Pre-post evaluation of physicians' satisfaction with a redesigned electronic medical record system.

    PubMed

    Jaspers, Monique W M; Peute, Linda W P; Lauteslager, Arnaud; Bakker, Piet J M

    2008-01-01

    Physicians' acceptance of Electronic Medical Record Systems (EMRs) is closely related to their usability. Knowledge about end-users' opinions on usability of an EMR system may contribute to planning for the next phase of the usability cycle of the system. A demand for integration of new functionalities, such as computerized order entry and an electronic patient status led to redesign of our EMR system, which had been in use for over 8 years at the Academic Medical Center of Amsterdam. The aim of this study was to understand whether the redesigned EMR system was an improvement of the earlier EMR and which system aspects accounted for user satisfaction and which did not. We conducted a formative pre- and post usability evaluation of our former and redesigned EMR system. For the assessment of both system versions' usability, we distributed two standardized usability questionnaires among 150 clinicians who routinely had used the older EMR system and had been working with its newer version for 6 weeks. Though overall user satisfaction was relatively high for both EMR systems, screen layout and interaction structure proved less easy to work with in the newer EMR system. The new EMR system however was more appreciated because of its enhanced functionality, capabilities and likeable user-interface. The results point to a number of actions that might be useful in future usability improvement efforts of our EMR system and other EMRs.

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

    PubMed

    Winhusen, Theresa; Theobald, Jeffrey; Lewis, Daniel

    2016-03-01

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

  2. Quantitative tumor segmentation for evaluation of extent of glioblastoma resection to facilitate multisite clinical trials.

    PubMed

    Cordova, James S; Schreibmann, Eduard; Hadjipanayis, Costas G; Guo, Ying; Shu, Hui-Kuo G; Shim, Hyunsuk; Holder, Chad A

    2014-02-01

    Standard-of-care therapy for glioblastomas, the most common and aggressive primary adult brain neoplasm, is maximal safe resection, followed by radiation and chemotherapy. Because maximizing resection may be beneficial for these patients, improving tumor extent of resection (EOR) with methods such as intraoperative 5-aminolevulinic acid fluorescence-guided surgery (FGS) is currently under evaluation. However, it is difficult to reproducibly judge EOR in these studies due to the lack of reliable tumor segmentation methods, especially for postoperative magnetic resonance imaging (MRI) scans. Therefore, a reliable, easily distributable segmentation method is needed to permit valid comparison, especially across multiple sites. We report a segmentation method that combines versatile region-of-interest blob generation with automated clustering methods. We applied this to glioblastoma cases undergoing FGS and matched controls to illustrate the method's reliability and accuracy. Agreement and interrater variability between segmentations were assessed using the concordance correlation coefficient, and spatial accuracy was determined using the Dice similarity index and mean Euclidean distance. Fuzzy C-means clustering with three classes was the best performing method, generating volumes with high agreement with manual contouring and high interrater agreement preoperatively and postoperatively. The proposed segmentation method allows tumor volume measurements of contrast-enhanced T 1-weighted images in the unbiased, reproducible fashion necessary for quantifying EOR in multicenter trials.

  3. Factors influencing hand washing behaviour in primary schools: process evaluation within a randomised controlled trial

    PubMed Central

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

    2013-01-01

    This paper explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomised controlled trial included pupil focus groups (n=16, ages 6 to 11, semi-structured interviews (n=16 teachers) and observations of hand washing facilities (n=57). Pupils and staff in intervention and control schools demonstrated a similar level of understanding of how, when and why they should wash their hands. Lack of time, poor adult modelling of regular hand washing and unattractive facilities were seen as important barriers to regular hand washing. Reminders and explanations for the importance of hand hygiene were thought to have a positive impact. Influencing individual choices about hand washing through education and information may be necessary, but not sufficient, for initiating and maintaining good hand washing practices. Structural factors, including having time to wash hands using accessible, clean facilities, and being encouraged through the existence of hand washing opportunities in the daily routine and hand washing being viewed as the social norm, will also influence hand washing behaviour. The effectiveness of educational interventions at improving hand hygiene in primary schools may be improved by changing priorities of staff and increasing accessibility to quality facilities. PMID:22623617

  4. Factors influencing hand washing behaviour in primary schools: process evaluation within a randomized controlled trial.

    PubMed

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

    2012-12-01

    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). Pupils and staff in intervention and control schools demonstrated a similar level of understanding of how, when and why they should wash their hands. Lack of time, poor adult modelling of regular hand washing and unattractive facilities were seen as important barriers to regular hand washing. Reminders and explanations for the importance of hand hygiene were thought to have a positive impact. Influencing individual choices about hand washing through education and information may be necessary, but not sufficient, for initiating and maintaining good hand washing practices. Structural factors, including having time to wash hands using accessible, clean facilities, and being encouraged through the existence of hand washing opportunities in the daily routine and hand washing being viewed as the social norm, will also influence hand washing behaviour. The effectiveness of educational interventions at improving hand hygiene in primary schools may be improved by changing priorities of staff and increasing accessibility to quality facilities.

  5. Quantitative Tumor Segmentation for Evaluation of Extent of Glioblastoma Resection to Facilitate Multisite Clinical Trials12

    PubMed Central

    Cordova, James S; Schreibmann, Eduard; Hadjipanayis, Costas G; Guo, Ying; Shu, Hui-Kuo G; Shim, Hyunsuk; Holder, Chad A

    2014-01-01

    Standard-of-care therapy for glioblastomas, the most common and aggressive primary adult brain neoplasm, is maximal safe resection, followed by radiation and chemotherapy. Because maximizing resection may be beneficial for these patients, improving tumor extent of resection (EOR) with methods such as intraoperative 5-aminolevulinic acid fluorescence-guided surgery (FGS) is currently under evaluation. However, it is difficult to reproducibly judge EOR in these studies due to the lack of reliable tumor segmentation methods, especially for postoperative magnetic resonance imaging (MRI) scans. Therefore, a reliable, easily distributable segmentation method is needed to permit valid comparison, especially across multiple sites. We report a segmentation method that combines versatile region-of-interest blob generation with automated clustering methods. We applied this to glioblastoma cases undergoing FGS and matched controls to illustrate the method's reliability and accuracy. Agreement and interrater variability between segmentations were assessed using the concordance correlation coefficient, and spatial accuracy was determined using the Dice similarity index and mean Euclidean distance. Fuzzy C-means clustering with three classes was the best performing method, generating volumes with high agreement with manual contouring and high interrater agreement preoperatively and postoperatively. The proposed segmentation method allows tumor volume measurements of contrast-enhanced T1-weighted images in the unbiased, reproducible fashion necessary for quantifying EOR in multicenter trials. PMID:24772206

  6. A 2-year young adult obesity prevention trial in the US: Process evaluation results.

    PubMed

    Laska, Melissa N; Sevcik, Sarah M; Moe, Stacey G; Petrich, Christine A; Nanney, Marilyn S; Linde, Jennifer A; Lytle, Leslie A

    2016-12-01

    Our objective was to conduct a process evaluation of the CHOICES (Choosing Healthy Options in College Environments and Settings) study, a large, randomized, controlled trial designed to prevent unhealthy weight gain in young adults (aged 18-35) attending 2-year community colleges in the USA. The 24-month intervention consisted of participation in an academic course and a social networking and support website. Among intervention participants, completion rates for most course activities were >80%, reflecting a high level of dose received. Course retention and participant satisfaction were also high. Engagement results, however, were mixed with less than half of participants in the online and hybrid sections of the course reporting that they interacted with course materials ≥3 h/week, but 50-75% reporting that they completed required lessons 'all/very thoroughly'. Engagement in the website activities was also mixed with more than half of intervention participants logging onto the website during the first month, but then declining to 25-40% during the following 23 months of the intervention. Intervention engagement is a challenge of online interventions and a challenge of working with the young adult age group in general. Additional research is needed to explore strategies to support engagement among this population, particularly for relatively long intervention durations.

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

    PubMed Central

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

    2011-01-01

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

  8. Motivating first-time, group O blood donors to return: Rationale and design of a randomized controlled trial of a post-donation telephone interview.

    PubMed

    France, Janis L; France, Christopher R; Carlson, Bruce W; Kessler, Debra A; Rebosa, Mark; Shaz, Beth H; Madden, Katrala; Carey, Patricia M

    2015-08-03

    First-time blood donors are essential to the US donor pool, providing nearly a third of all donations. Unfortunately, there are a wide variety of obstacles to repeat donation and new donors are extremely difficult to retain. Because each donor experiences a unique set of deterrents, we developed a post-donation interview based on motivational interview principles in order to flexibly address individual barriers. The primary aim of this randomized clinical trial is to examine retention of first-time, group O blood donors who are randomly assigned to receive either a telephone-delivered interview with motivational and action planning components or a standard-of-care control call approximately six weeks after their donation. Measures of donation attitude, perceived behavioral control, intention, and motivational autonomy will be measured before and after the telephone contact using online surveys, and donation attempts will be tracked for one year using blood center donor databases. We hypothesize that, compared to controls, donors who receive the telephone interview will be more likely to make a donation attempt over the following year. In addition, we will examine possible mechanisms of action of the interview using key predictors of donation behavior as described by Self Determination Theory (i.e., motivational autonomy) and the Theory of Planned Behavior (i.e., attitude, perceived behavioral control, and intention). Results of this intervention may help to support a novel strategy to enhance retention of selected blood donors in an effort to better meet the nation's blood supply needs.

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

    PubMed

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

    2016-02-01

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

  10. Skills for Psychological Recovery: Evaluation of a post-disaster mental health training program

    PubMed Central

    Wade, Darryl; Crompton, David; Howard, Alexandra; Stevens, Naomi; Metcalf, Olivia; Brymer, Melissa; Ruzek, Josef; Watson, Patricia; Bryant, Richard; Forbes, David

    2014-01-01

    Skills for Psychological Recovery (SPR) is a brief skills-based approach to assist community members to better cope after a disaster or other tragedy. This paper reports on an evaluation of a large SPR training and support program following floods and cyclones in Queensland, Australia. The program sought to recruit, train and support competent SPR trainers; provide systematic high-quality training in SPR skills for practitioners; improve the confidence of a large number of practitioners to use SPR; and encourage practitioners' use of SPR with community members. Trainers recruited to the program facilitated 49 training sessions for 788 practitioners across Queensland. Trainers were assessed by practitioners to have high-level competencies to run training sessions. Practitioners reported improved confidence to use each SPR intervention following training and at 6 months post-training. Based on available data, more than 6 out of 10 practitioners used an SPR intervention during the follow up period, with each intervention used by over half of the practitioners at both 3 and 6 months. The most frequently reported barrier to using SPR was not having seen a community member with problems requiring SPR. For trainers, a psychology background and cognitive-behavioral therapy (CBT) orientation were unrelated to their competencies to facilitate practitioner training sessions. For practitioners, a psychology background and to some extent a CBT orientation were related to confidence to use SPR interventions. In summary, this study provides details of an evaluation of a large-scale mental health training and support program to enhance response to meet the mental health needs of those affected by disaster. PMID:28229008

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

    ERIC Educational Resources Information Center

    Rogers, Lynne; Hallam, Susan

    2013-01-01

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

  12. 78 FR 36571 - Extension of Post-Sale Evaluation Period for Central Gulf of Mexico Planning Area Lease Sale 227

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... Bureau of Ocean Energy Management Extension of Post-Sale Evaluation Period for Central Gulf of Mexico Planning Area Lease Sale 227 AGENCY: Bureau of Ocean Energy Management (BOEM), Interior. ACTION: Notice to...-2710. Dated: June 11, 2013. Walter D. Cruickshank, Deputy Director, Bureau of Ocean and...

  13. Working with the European Language Portfolio in Irish Post-Primary Schools: Report on an Evaluation Project. CLCS Occasional Paper.

    ERIC Educational Resources Information Center

    Ushioda, Ema; Ridley, Jennifer

    This report describes a qualitative research project designed to evaluate the use of the European Language Portfolio (ELP) in Irish post-primary schools. The project was coordinated by the Centre for Language and Communication Studies, Trinity College Dublin, and involved the participation of language teachers and learners from a number of schools…

  14. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    PubMed

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  15. Evaluation of Interval Times from Onset to Reperfusion in Patients Undergoing Endovascular Therapy in the IMS III Trial

    PubMed Central

    Goyal, Mayank; Almekhlafi, Mohammed A; Fan, Liqiong; Menon, Bijoy K; Demchuk, Andrew M; Yeatts, Sharon D; Hill, Michael D; Tomsick, Thomas; Khatri, Pooja; Zaidat, Osama O; Jauch, Edward C; Eesa, Muneer; Jovin, Tudor G; Broderick, Joseph P

    2014-01-01

    Background Meaningful delays occurred in the IMS III trial. Analysis of the workflow will identify factors contributing to the in-hospital delays. Methods and Results In the endovascular arm of the IMS III trial, these time intervals were calculated: stroke onset to ED arrival; ED to CT; CT to IV tPA start; IV tPA start to randomization; randomization to groin puncture; groin puncture to thrombus identification; thrombus identification to start of endovascular therapy; start of endovascular therapy to reperfusion. The effects of enrollment time, CTA use, inter-hospital transfers, and intubation on workflow were evaluated. Delays notably occurred in the time intervals from IV tPA initiation to groin puncture (median 84 minutes) and start of endovascular therapy to reperfusion (median 85 minutes). The CT to groin puncture time was significantly shorter during working hours than after. Times from ED to reperfusion and groin puncture to reperfusion decreased over the trial period. Patients with CTA had shorter ED to reperfusion and onset to reperfusion times. Transfer of patients resulted in a longer onset to reperfusion time compared to those treated in the same center. Age, sex, NIHSS, and intubation did not impact delays. Conclusions Important delays were identified prior to reperfusion in the IMS III trial. Delays decreased as the trial progressed. Use of CTA and endovascular treatment in the same center were associated with time savings. These data may help in optimizing workflow in current and future endovascular trials. Clinical Trial Registration Information http://clinicaltrials.gov. Identifier: NCT00359424. PMID:24815501

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

    PubMed

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

    2016-05-01

    Biological mediators have been used to enhance periodontal regeneration. The aim of this prospective randomized controlled study was to evaluate the safety and effectiveness of 3 doses of fibroblast growth factor 2 (FGF-2) when combined with a β-tricalcium phosphate (β-TCP) scaffold carrier placed in vertical infrabony periodontal defects in adult patients. In this double-blinded, dose-verification, externally monitored clinical study, 88 patients who required surgical intervention to treat a qualifying infrabony periodontal defect were randomized to 1 of 4 treatment groups-β-TCP alone (control) and 0.1% recombinant human FGF-2 (rh-FGF-2), 0.3% rh-FGF-2, and 0.4% rh-FGF-2 with β-TCP-following scaling and root planing of the tooth prior to a surgical appointment. Flap surgery was performed with EDTA conditioning of the root prior to device implantation. There were no statistically significant differences in patient demographics and baseline characteristics among the 4 treatment groups. When a composite outcome of gain in clinical attachment of 1.5 mm was used with a linear bone growth of 2.5 mm, a dose response pattern detected a plateau in the 0.3% and 0.4% rh-FGF-2/β-TCP groups with significant improvements over control and 0.1% rh-FGF-2/β-TCP groups. The success rate at 6 mo was 71% in the 2 higher-concentration groups, as compared with 45% in the control and lowest treatment groups. Percentage bone fill in the 2 higher-concentration groups was 75% and 71%, compared with 63% and 61% in the control and lowest treatment group. No increases in specific antibody to rh-FGF-2 were detected, and no serious adverse events related to the products were reported. The results from this multicenter trial demonstrated that the treatment of infrabony vertical periodontal defects can be enhanced with the addition of rh-FGF-2/β-TCP (ClinicalTrials.gov NCT01728844).

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

    PubMed Central

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

    2015-01-01

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

  18. Influence of preinfarction angina and coronary collateral blood flow on the efficacy of remote ischaemic conditioning in patients with ST segment elevation myocardial infarction: post hoc subgroup analysis of a randomised controlled trial

    PubMed Central

    Pryds, Kasper; Bøttcher, Morten; Sloth, Astrid Drivsholm; Munk, Kim; Rahbek Schmidt, Michael; Bøtker, Hans Erik

    2016-01-01

    Objectives Remote ischaemic conditioning (RIC) confers cardioprotection in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). We investigated whether preinfarction angina and coronary collateral blood flow (CCBF) to the infarct-related artery modify the efficacy of RIC. Design Post hoc subgroup analysis of a randomised controlled trial. Participants A total of 139 patients with STEMI randomised to treatment with pPCI or RIC+pPCI. Interventions RIC was performed prior to pPCI as four cycles of 5 min upper arm ischaemia and reperfusion with a blood pressure cuff. Primary outcome measure Myocardial salvage index (MSI) assessed by single-photon emission computerised tomography. We evaluated the efficacy of RIC in subgroups of patients with or without preinfarction angina or CCBF. Results Of 139 patients included in the study, 109 had available data for preinfarction angina status and 54 had preinfarction angina. Among 83 patients with Thrombolysis In Myocardial Infarction flow 0/1 on arrival, 43 had CCBF. Overall, RIC+pPCI increased median MSI compared with pPCI alone (0.75 vs 0.56, p=0.045). Mean MSI did not differ between patients with and without preinfarction angina in either the pPCI alone (0.58 and 0.57; 95% CI −0.17 to 0.19, p=0.94) or the RIC+pPCI group (0.66 and 0.69; 95% CI −0.18 to 0.10, p=0.58). Mean MSI did not differ between patients with and without CCBF in the pPCI alone group (0.51 and 0.55; 95% CI −0.20 to 0.13, p=0.64), but was increased in patients with CCBF versus without CCBF in the RIC+pPCI group (0.75 vs 0.58; 95% CI 0.03 to 0.31, p=0.02; effect modification from CCBF on the effect of RIC on MSI, p=0.06). Conclusions Preinfarction angina did not modify the efficacy of RIC in patients with STEMI undergoing pPCI. CCBF to the infarct-related artery seems to be of importance for the cardioprotective efficacy of RIC. Trial registration number NCT00435266, Post

  19. An integrative review of standardized clinical evaluation tool utilization in anticholinergic drug trials for neurogenic lower urinary tract dysfunction

    PubMed Central

    Stothers, L; Tsang, B; Nigro, M; Lazare, D; Macnab, A

    2016-01-01

    Study design: To review prospective and randomized trials studying anticholinergic therapy for neurogenic bladder in SCI to identify whether trials included standardized clinical evaluation tools and reporting measures now recognized to enhance clinical trial data. Methods: A systematic search via EMBASE, MEDLINE, CENTRAL, CINAHL (Cumulative Index to Nursing and Allied Health Literature), HTA (Health Technology Assessment), CMR (Comprehensive Microbial Resource), HAPI (Health and Psychosocial Instruments) and PsycINFO using the key term spinal cord injury crossed with oxybutynin, tolterodine, darifenacin, solifenacin, fesoterodine, trospium chloride, propiverine, propantheline and anticholinergic(s) for 1946–2015 inclusive. We then collated whether standardized clinical tools, measures and descriptors were used within each study identified: American Spine Injury Association (ASIA) impairment scale; symptom scores validated in SCI; technical methodology for urodynamics/video urodynamics; urinary diaries; and standardized urologic terminology. Results: A total of 1225 entries with 610 unique articles were identified, 14 randomized and 16 prospective studies. In 6/30 the population comprised SCI patients with neurogenic bladder alone; the remainder included mixed neurogenic etiologies. Classification using the ASIA impairment scale was used in <10% of studies; none used symptom scores validated in SCI; <50% reported urodynamic test methodology fully, incorporated urinary diaries or used International Continence Society Standardization Subcommittee urinary tract terminology. Conclusion: Integrative review of trials from 1946 to 2015 identified infrequent use of standardized clinical evaluation tools and reporting measures. Data from future trials evaluating therapies for neurogenic bladder would likely be more applicable to specific SCI patients if current standardized classification and descriptors now available were used consistently: for example, the ASIA scale

  20. Evaluating the family nurse partnership in England: the Building Blocks trial.

    PubMed

    Sanders, Julia; Owen-Jones, Eleri; Robling, Mike

    2011-01-01

    The Family Nurse Partnership (FNP) Programme is a structured intensive home visiting programme delivered by trained family nurses to nulliparous teenagers throughout pregnancy and until their child is two years old. Currently FNP is provided in over 60 primary healthcare sites in England with a planned capacity increase to 13,000 concurrent clients by 2015. Researchers from the South East Wales Trials Unit at Cardiff University are testing the effectiveness of FNP in England in the Building Blocks study--a randomised controlled trial funded by the Department of Health (DH). The trial team includes collaborators from the Universities of York, Bristol and Glamorgan.

  1. Evaluation of CMIP5 Models for post-1950 Weakening of Indian Monsoon

    NASA Astrophysics Data System (ADS)

    Saha, Anamitra; Saheer, Sahana; Ghosh, Subimal; Rao Emmela, Panakala

    2015-04-01

    Indian summer monsoon rainfall (ISMR) impacts the life of more than one billion people; the mean seasonal (from June to September) rainfall contributes to 80% of total annual rainfall in India; and the intraseasonal to interannual variability controls the agricultural productivity and the gross domestic product (GDP) of the country. ISMR has been found to have a decreasing trend in the recent decades (post-1950), which poses a major threat to water and food security of India. In order to adapt to such changes, reliable projection of ISMR by General Circulation Models (GCM) is required. But majority of new generation climate models from Coupled Model Inter-comparison Project phase5 (CMIP5) fail to simulate the observed decreasing trend of ISMR; most of the models show either no trend or increasing trend. The reason behind such failure is investigated and it has been found that large scale geophysical processes, which are responsible for weakening of Indian monsoon, are not very well simulated by the climate models. The decreasing trend of ISMR is associated with the warming of Southern Indian Ocean (SIO) and anomalous cyclonic formation in the western tropical Pacific Ocean. Increase in sea surface temperature (SST) and expansion of warm pool in SIO in recent decades has decreased the meridional SST gradient and weakened the monsoon south-westerly winds. On the other hand, increasing SST and strengthening anomalous cyclonic formation in Pacific Ocean has set a favourable condition for increasing local precipitation, which brings cold and dry wind from continental subtropics to south Asian monsoon region by teleconnection. Both of these large scale changes are not properly captured by CMIP5 models, with few exceptions, which is responsible for their failure. Proper representation of these highlighted geophysical processes in next generation models, may improve the reliability of ISMR projections. Findings of this study alert the water resource planners to evaluate

  2. Perceptual and acoustic evaluation of individuals with laryngopharyngeal reflux pre- and post-treatment.

    PubMed

    Selby, Julia C; Gilbert, Harvey R; Lerman, J W

    2003-12-01

    Thirteen individuals with laryngopharyngeal reflux (LPR) were studied pre- and post-treatment. The effect of treatment on perceptual ratings of voice quality and frequency and intensity measures was examined. Relationships between perceptual and acoustic parameters were assessed descriptively. Results showed a small, but significant improvement in the perception of voice quality post-treatment. No significant differences were found between pre- and post-treatment means for any of the acoustic measures except harmonics-to-noise ratio (HNR). Descriptive analyses showed some association between perceptual ratings and acoustic measures. Discussion of results focuses on severity of LPR.

  3. The influence of quality criteria on parents' evaluation of medical web-pages: an Italian randomised trial.

    PubMed

    Currò, Vincenzo; Buonuomo, Paola Sabrina; Zambiano, Annaluce; Vituzzi, Andrea; Onesimo, Roberta; D'Atri, Alessandro

    2007-01-01

    The aim of this study is to verify the usefulness for parents of a web evaluation framework composed of ten quality criteria to improve their ability to assess the quality level of medical web sites. We conducted a randomised controlled trial that included two groups of parents who independently evaluated five paediatric web sites by filling out two distinct questionnaires: group A with the evaluation framework, group B without it. 40 volunteers were recruited from parents referring to the General Paediatrics Out-patients Department who satisfied the following eligibility criteria: Internet users, at least 1 child under 12 months old, no professional skill in Internet and medicine. The survey was taken between February 2, 2000 and March 22, 2000. Parents evaluated each web site and assigned a score, compared with a gold standard created by a group of experts. Suggesting evaluation criteria to parents seem useful for an improvement of their ability to evaluate web sites.

  4. An outline for public registration of clinical trials evaluating medical devices.

    PubMed

    Popp, Richard L; Lorell, Beverly H; Stone, Gregg W; Laskey, Warren; Smith, John J; Kaplan, Aaron V

    2006-04-18

    Public registration of clinical trials is fundamentally important to the integrity of the medical device development process. In addition to fulfilling obligations to those study volunteers, a complete record of trial results provides the general public, clinical community, and medical device manufacturers with a more accurate understanding as to how a specific therapeutic should be used. Although the issues associated with public disclosure of clinical trials are similar to the pharmaceutical industries, the iterative nature of device development introduces differences in what type of information needs to be disclosed during development and commercialization. The Second Dartmouth Device Development Symposium (3D2) held in October 2004 brought together thought leaders representing many of the stakeholders associated with medical device development. This consensus document arising from the proceedings of the 3D2 is offered to provide background to these issues and recommend pathways to implementation of device trial registration.

  5. Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh

    PubMed Central

    Shillcutt, Samuel D; Waters, Hugh R; Haider, Sabbir; El Arifeen, Shams; Mannan, Ishtiaq; Seraji, Habibur R; Shah, Rasheduzzaman; Darmstadt, Gary L; Wall, Steve N; Williams, Emma K; Black, Robert E; Santosham, Mathuram; Baqui, Abdullah H

    2013-01-01

    Abstract Objective To evaluate and compare the cost-effectiveness of two strategies for neonatal care in Sylhet division, Bangladesh. Methods In a cluster-randomized controlled trial, two strategies for neonatal care – known as home care and community care – were compared with existing services. For each study arm, economic costs were estimated from a societal perspective, inclusive of programme costs, provider costs and household out-of-pocket payments on care-seeking. Neonatal mortality in each study arm was determined through household surveys. The incremental cost-effectiveness of each strategy – compared with that of the pre-existing levels of maternal and neonatal care – was then estimated. The levels of uncertainty in our estimates were quantified through probabilistic sensitivity analysis. Findings The incremental programme costs of implementing the home-care package were 2939 (95% confidence interval, CI: 1833–7616) United States dollars (US$) per neonatal death averted and US$ 103.49 (95% CI: 64.72–265.93) per disability-adjusted life year (DALY) averted. The corresponding total societal costs were US$ 2971 (95% CI: 1844–7628) and US$ 104.62 (95% CI: 65.15–266.60), respectively. The home-care package was cost-effective – with 95% certainty – if healthy life years were valued above US$ 214 per DALY averted. In contrast, implementation of the community-care strategy led to no reduction in neonatal mortality and did not appear to be cost-effective. Conclusion The home-care package represents a highly cost-effective intervention strategy that should be considered for replication and scale-up in Bangladesh and similar settings elsewhere. PMID:24115797

  6. Evaluation of a Musculoskeletal Model with Prosthetic Knee through Six Experimental Gait Trials

    PubMed Central

    Kia, Mohammad; Stylianou, Antonis P.; Guess, Trent M.

    2015-01-01

    Knowledge of the forces acting on musculoskeletal joint tissues during movement benefits tissue engineering, artificial joint replacement, and our understanding of ligament and cartilage injury. Computational models can be used to predict these internal forces, but musculoskeletal models that simultaneously calculate muscle force and the resulting loading on joint structures are rare. This study used publicly available gait, skeletal geometry, and instrumented prosthetic knee loading data [1] to evaluate muscle driven forward dynamics simulations of walking. Inputs to the simulation were measured kinematics and outputs included muscle, ground reaction, ligament, and joint contact forces. A full body musculoskeletal model with subject specific lower extremity geometries was developed in the multibody framework. A compliant contact was defined between the prosthetic femoral component and tibia insert geometries. Ligament structures were modeled with a nonlinear force-strain relationship. The model included 45 muscles on the right lower leg. During forward dynamics simulations a feedback control scheme calculated muscle forces using the error signal between the current muscle lengths and the lengths recorded during inverse kinematics simulations. Predicted tibiofemoral contact force, ground reaction forces, and muscle forces were compared to experimental measurements for six different gait trials using three different gait types (normal, trunk sway, and medial thrust). The mean average deviation (MAD) and root mean square deviation (RMSD) over one gait cycle are reported. The muscle driven forward dynamics simulations were computationally efficient and consistently reproduced the inverse kinematics motion. The forward simulations also predicted total knee contact forces (166 N < MAD < 404 N, 212 N < RMSD < 448 N) and vertical ground reaction forces (66 N < MAD < 90 N, 97 N < RMSD < 128 N) well within 28% and 16% of experimental loads respectively. However the

  7. Evaluation of an intervention to improve blood culture practices: a cluster randomised trial.

    PubMed

    Pavese, P; Maillet, M; Vitrat-Hincky, V; Recule, C; Vittoz, J-P; Guyomard, A; Seigneurin, A; François, P

    2014-12-01

    This study aimed to evaluate an intervention to improve blood culture practices. A cluster randomised trial in two parallel groups was performed at the Grenoble University Hospital, France. In October 2009, the results of a practices audit and the guidelines for the optimal use of blood cultures were disseminated to clinical departments. We compared two types of information dissemination: simple presentation or presentation associated with an infectious diseases (ID) specialist intervention. The principal endpoint was blood culture performance measured by the rate of patients having one positive blood culture and the rate of positive blood cultures. The cases of 130 patients in the "ID" group and 119 patients in the "simple presentation" group were audited during the second audit in April 2010. The rate of patients with one positive blood culture increased in both groups (13.62 % vs 9.89 % for the ID group, p = 0.002, 15.90 % vs 13.47 % for the simple presentation group, p = 0.009). The rate of positive blood cultures improved in both groups (6.68 % vs 5.96 % for the ID group, p = 0.003, 6.52 % vs 6.21 % for the simple presentation group, p = 0.017). The blood culture indication was significantly less often specified in the request form in the simple presentation group, while it remained stable in the ID group (p = 0.04). The rate of positive blood cultures and the rate of patients having one positive blood culture improved in both groups. The ID specialist intervention did not have more of an impact on practices than a simple presentation of audit feedback and guidelines.

  8. Evaluation of a musculoskeletal model with prosthetic knee through six experimental gait trials.

    PubMed

    Kia, Mohammad; Stylianou, Antonis P; Guess, Trent M

    2014-03-01

    Knowledge of the forces acting on musculoskeletal joint tissues during movement benefits tissue engineering, artificial joint replacement, and our understanding of ligament and cartilage injury. Computational models can be used to predict these internal forces, but musculoskeletal models that simultaneously calculate muscle force and the resulting loading on joint structures are rare. This study used publicly available gait, skeletal geometry, and instrumented prosthetic knee loading data [1] to evaluate muscle driven forward dynamics simulations of walking. Inputs to the simulation were measured kinematics and outputs included muscle, ground reaction, ligament, and joint contact forces. A full body musculoskeletal model with subject specific lower extremity geometries was developed in the multibody framework. A compliant contact was defined between the prosthetic femoral component and tibia insert geometries. Ligament structures were modeled with a nonlinear force-strain relationship. The model included 45 muscles on the right lower leg. During forward dynamics simulations a feedback control scheme calculated muscle forces using the error signal between the current muscle lengths and the lengths recorded during inverse kinematics simulations. Predicted tibio-femoral contact force, ground reaction forces, and muscle forces were compared to experimental measurements for six different gait trials using three different gait types (normal, trunk sway, and medial thrust). The mean average deviation (MAD) and root mean square deviation (RMSD) over one gait cycle are reported. The muscle driven forward dynamics simulations were computationally efficient and consistently reproduced the inverse kinematics motion. The forward simulations also predicted total knee contact forces (166N

  9. Evaluation of orthodontic treatment after 1 year of retention--a randomized controlled trial.

    PubMed

    Edman Tynelius, G; Bondemark, L; Lilja-Karlander, E

    2010-10-01

    The aim of this study was to use a randomized controlled trial methodology to evaluate and compare three different retention methods. The capacity of the retention methods to retain orthodontic treatment results was in this first phase analysed on a short-term basis, i.e. after 1 year of retention. The subjects were recruited from adolescents undergoing fixed appliance treatment at an orthodontic clinic in the National Health Service (NHS) in Sweden between 2001 and 2007. Seventy-five patients (45 girls and 30 boys with a mean age of 14.4 years at the start of retention) were randomized into three retention systems; a vacuum-formed retainer in the maxilla and bonded canine-to-canine retainer in the mandible (group V-CTC), a vacuum-formed retainer in the maxilla combined with stripping of the 10 proximal surfaces of the lower mandibular anterior teeth (group V-S), and a prefabricated positioner covering the teeth in the maxilla and mandible (group P). The main outcome measures were: Little's irregularity index (LII), intercanine and intermolar width, arch length, overjet, and overbite. Registrations were made before orthodontic treatment, when the fixed orthodontic appliance was removed, and after 12 months in retention. Differences in means between groups were tested by one-way analysis of variance. After 1 year of retention, no clinically significant difference in retention capacity was found between the three retention methods. Small but significant differences (P < 0.05) were observed between the V-CTC and V-S groups regarding mandibular canine width, mandibular arch length, and overbite. In group P, two patients failed to co-operate.

  10. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    PubMed

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  11. Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-‘Tabac Info Service’: ee-TIS trial

    PubMed Central

    Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F

    2017-01-01

    Introduction A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. Methods and analyses The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. Ethics and dissemination The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. Trial registration

  12. The Devon Active Villages Evaluation (DAVE) trial of a community-level physical activity intervention in rural south-west England: a stepped wedge cluster randomised controlled trial

    PubMed Central

    2014-01-01

    Background The majority of adults are not meeting the guidelines for physical activity despite activity being linked with numerous improvements to long-term health. In light of this, researchers have called for more community-level interventions. The main objective of the present study was to evaluate whether a community-level physical activity intervention increased the activity levels of rural communities. Methods 128 rural villages (clusters) were randomised to receive the intervention in one of four time periods between April 2011 and December 2012. The Devon Active Villages intervention provided villages with 12 weeks of physical activity opportunities for all age groups, including at least three different types of activities per village. Each village received an individually tailored intervention, incorporating a local needs-led approach. Support was provided for a further 12 months following the intervention. The evaluation study used a stepped wedge cluster randomised controlled trial design. All 128 villages were measured at each of five data collection periods using a postal survey. The primary outcome of interest was the proportion of adults reporting sufficient physical activity to meet internationally recognised guidelines. Minutes spent in moderate-and-vigorous activity per week was analysed as a secondary outcome. To compare between intervention and control modes, random effects linear regression and marginal logistic regression models were implemented for continuous and binary outcomes respectively. Results 10,412 adults (4693 intervention, 5719 control) completed the postal survey (response rate 32.2%). The intervention did not increase the odds of adults meeting the physical activity guideline (adjusted OR 1.02, 95% CI: 0.88 to 1.17; P = 0.80), although there was weak evidence of an increase in minutes of moderate-and-vigorous-intensity activity per week (adjusted mean difference = 171, 95% CI: -16 to 358; P = 0.07). The

  13. Evaluating the Role of Compression Stockings in Preventing Post thrombotic Syndrome: A Review of the Literature.

    PubMed

    Kanaan, Abir O; Lepage, Jayne E; Djazayeri, Shabdis; Donovan, Jennifer L

    2012-01-01

    Background. Postthrombotic syndrome (PTS) is a burdensome and costly complication of deep vein thrombosis (DVT). Up to 50% of patients with DVT will develop the disease within two years following the diagnosis of acute DVT. Various risk factors for developing PTS have been identified and different modalities have been used to prevent its development. Compression stockings have been studied for the prevention of PTS in patients diagnosed with proximal DVT. Methods. MEDLINE and EMBASE databases were searched to identify relevant original articles. Results. Several trials including two metaanalyses have examined the role of compression stockings for the prevention of PTS. Although most trials showed significant reduction in the development of PTS with the use of compression stockings, limitations in study design prevent the generalizability of the data. Two studies supported an individualized tailored duration especially in patients at low risk for developing the syndrome. A randomized double-blind placebo-controlled trial involving 800 patients is currently ongoing and may confirm the results of older studies. Conclusions. Clinical trials support the use of compression stockings in patients diagnosed with proximal DVT for the prevention of PTS.

  14. A clinical trial evaluating the laryngeal mask airway-Supreme in obese children during general anesthesia

    PubMed Central

    Tian, Yue; Li, Lu; Ma, Ling; Li, Yun-feng

    2016-01-01

    Introduction The laryngeal mask airway (LMA)-Supreme is a disposable double-lumen laryngeal mask airway that is widely used in clinical practice. However, its use in obese children has not been evaluated. The aim of this study was to determine whether the LMA-Supreme could perform equally as well as endotracheal intubation in obese children having a minor surgical procedure. Material and methods After ethical board approval, 100 obese male children receiving non-emergent appendectomy for chronic appendicitis or surgery to correct concealed penis were randomly divided into an endotracheal intubation group and an LMA-Supreme group. Endotracheal intubation was performed under direct vision laryngoscopy. In the LMA group, a size-3 LMA-Supreme was placed and a stomach tube inserted via the drainage tube of the mask. Cardiovascular and respiratory parameters, time taken for placement, placement attempts, time to removal of the endotracheal tube/LMA, length of stay in the post-anesthesia care unit (PACU), and complications were recorded. Results Insertion time was significantly longer (p < 0.001) in the LMA-Supreme group than in the endotracheal intubation group. Peak airway pressure was significantly higher, and pulmonary compliance and PACU stay time lower in the LMA-Supreme group. No significant differences between endotracheal intubation and the LMA-Supreme were seen in other parameters, except for a higher incidence of coughing in the endotracheal intubation group. Conclusions The LMA-Supreme can be easily inserted and effectively used for airway management in obese children undergoing minor surgery. PMID:28144270

  15. Refractory depression: mechanisms and evaluation of radically open dialectical behaviour therapy (RO-DBT) [REFRAMED]: protocol for randomised trial

    PubMed Central

    Lynch, T R; Whalley, B; Hempel, R J; Byford, S; Clarke, P; Clarke, S; Kingdon, D; O'Mahen, H; Russell, I T; Shearer, J; Stanton, M; Swales, M; Watkins, A; Remington, B

    2015-01-01

    Introduction Only 30–40% of depressed patients treated with medication achieve full remission. Studies that change medication or augment it by psychotherapy achieve only limited benefits, in part because current treatments are not designed for chronic and complex patients. Previous trials have excluded high-risk patients and those with comorbid personality disorder. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a novel, transdiagnostic treatment for disorders of emotional over-control. The REFRAMED trial aims to evaluate the effectiveness and cost-effectiveness of RO-DBT for patients with treatment-resistant depression. Methods and analysis REFRAMED is a multicentre randomised controlled trial, comparing 7 months of individual and group RO-DBT treatment with treatment as usual (TAU). Our primary outcome measure is depressive symptoms 12 months after randomisation. We shall estimate the cost-effectiveness of RO-DBT by cost per quality-adjusted life year. Causal analyses will explore the mechanisms by which RO-DBT is effective. Ethics and dissemination The National Research Ethics Service (NRES) Committee South Central – Southampton A first granted ethical approval on 20 June 2011, reference number 11/SC/0146. Trial registration number ISRCTN85784627. PMID:26187121

  16. Quantitative evaluation of multi-parametric MR imaging marker changes post-laser interstitial ablation therapy (LITT) for epilepsy

    NASA Astrophysics Data System (ADS)

    Tiwari, Pallavi; Danish, Shabbar; Wong, Stephen; Madabhushi, Anant

    2013-03-01

    Laser-induced interstitial thermal therapy (LITT) has recently emerged as a new, less invasive alternative to craniotomy for treating epilepsy; which allows for focussed delivery of laser energy monitored in real time by MRI, for precise removal of the epileptogenic foci. Despite being minimally invasive, the effects of laser ablation on the epileptogenic foci (reflected by changes in MR imaging markers post-LITT) are currently unknown. In this work, we present a quantitative framework for evaluating LITT-related changes by quantifying per-voxel changes in MR imaging markers which may be more reflective of local treatment related changes (TRC) that occur post-LITT, as compared to the standard volumetric analysis which involves monitoring a more global volume change across pre-, and post-LITT MRI. Our framework focuses on three objectives: (a) development of temporal MRI signatures that characterize TRC corresponding to patients with seizure freedom by comparing differences in MR imaging markers and monitoring them over time, (b) identification of the optimal time point when early LITT induced effects (such as edema and mass effect) subside by monitoring TRC at subsequent time-points post-LITT, and (c) identification of contributions of individual MRI protocols towards characterizing LITT-TRC for epilepsy by identifying MR markers that change most dramatically over time and employ individual contributions to create a more optimal weighted MP-MRI temporal profile that can better characterize TRC compared to any individual imaging marker. A cohort of patients were monitored at different time points post-LITT via MP-MRI involving T1-w, T2-w, T2-GRE, T2-FLAIR, and apparent diffusion coefficient (ADC) protocols. Post affine registration of individual MRI protocols to a reference MRI protocol pre-LITT, differences in individual MR markers are computed on a per-voxel basis, at different time-points with respect to baseline (pre-LITT) MRI as well as across subsequent time

  17. Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

    PubMed Central

    Schouten, Jeffrey T.; Dixon, Dennis; Varghese, Suresh; Cope, Marie T.; Marci, Joe; Kagan, Jonathan M.

    2014-01-01

    Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects

  18. Estimating the Single-Trial Characteristics of Event-Related Responses: Evaluation of the MCERP Algorithm

    NASA Technical Reports Server (NTRS)

    Knuth, K. H.; Shah, A. S.; Truccolo, W. A.; Ding, M.; Bressler, S. L.; Schroeder, C. E.; Korsmey, Dave (Technical Monitor)

    2002-01-01

    Single-trial event-related responses collected during the course of an experiment are typically averaged before analysis resulting in a rather crude picture of event-related brain dynamics. It has been quite clear for some time that these responses exhibit trial-to-trial variability: however, the computational techniques necessary to deal with such responses in noisy conditions have not been available. To this end we have developed the multiple-component, event-related potential model (mcERP), which assumes that the each event-related response consists of a sum of multiple evoked components each described by a stereotypical waveshape. These waveshapes are allowed to vary in amplitude and onset latency from trial to trial, which allows us to capture, to first-order, the trial-dependent variations in event-related brain dynamics. We have constructed many sets of synthetic data designed to simulate intracortical recordings from a 15 channel, linear-array multielectrode implanted acutely in V1 of an awake-behaving macaque undergoing visual stimulation with a red light flash. This synthetic data was used to characterize the performance of the mcERP algorithm. First we quantified the degree to which such trial-to-trial variability aids in the identification of multiple components, and we demonstrate that amplitude variability is a more important factor in component separation than latency variability. Second, we quantified the behavior of the algorithm under two distinct signal-to-noise ratio (SNR) conditions: Gaussian noise independently present in each channel, and highly correlated (1/f distributed), far-field noise presented identically in each channel of the array. The mcERP algorithm was found to be robust to noise accurately identifying all component waveshapes and their associated single-trial characteristics down to SNR levels of -20dB for Gaussian noise and -7dB for 1/f far-field noise. Comparisons of the performance of this algorithm with factor analysis (FA

  19. Methods for testing theory and evaluating impact in randomized field trials

    PubMed Central

    Brown, C. Hendricks; Wang, Wei; Kellam, Sheppard G.; Muthén, Bengt O.; Petras, Hanno; Toyinbo, Peter; Poduska, Jeanne; Ialongo, Nicholas; Wyman, Peter A.; Chamberlain, Patricia; Sloboda, Zili; MacKinnon, David P.; Windham, Amy

    2008-01-01

    Randomized field trials provide unique opportunities to examine the effectiveness of an intervention in real world settings and to test and extend both theory of etiology and theory of intervention. These trials are designed not only to test for overall intervention impact but also to examine how impact varies as a function of individual level characteristics, context, and across time. Examination of such variation in impact requires analytical methods that take into account the trial’s multiple nested structure and the evolving changes in outcomes over time. The models that we describe here merge multilevel modeling with growth modeling, allowing for variation in impact to be represented through discrete mixtures—growth mixture models—and nonparametric smooth functions—generalized additive mixed models. These methods are part of an emerging class of multilevel growth mixture models, and we illustrate these with models that examine overall impact and variation in impact. In this paper, we define intent-to-treat analyses in group-randomized multilevel field trials and discuss appropriate ways to identify, examine, and test for variation in impact without inflating the Type I error rate. We describe how to make causal inferences more robust to misspecification of covariates in such analyses and how to summarize and present these interactive intervention effects clearly. Practical strategies for reducing model complexity, checking model fit, and handling missing data are discussed using six randomized field trials to show how these methods may be used across trials randomized at different levels. PMID:18215473

  20. Evaluation of a peer network-based sexual risk reduction intervention for men in beer halls in Zimbabwe: results from a randomized controlled trial.

    PubMed

    Fritz, Katherine; McFarland, Willi; Wyrod, Robert; Chasakara, Charles; Makumbe, Knox; Chirowodza, Admire; Mashoko, Chamunorwa; Kellogg, Timothy; Woelk, Godfrey

    2011-11-01

    While much emphasis has been placed on involving men in AIDS prevention in sub-Saharan Africa, there remain few rigorously evaluated interventions in this area. A particularly appealing point of intervention is the sexual risk behavior associated with men's alcohol consumption. This article reports the outcomes of The Sahwira HIV Prevention Program, a male-focused, peer-based intervention promoting the idea that men can assist their friends in avoiding high-risk sexual encounters associated with alcohol drinking. The intervention was evaluated in a randomized, controlled trial (RCT) implemented in 24 beer halls in Harare, Zimbabwe. A cadre of 413 male beer hall patrons (~20% of the patronage) was trained to assist their male peers within their friendship networks. Activities included one-on-one interactions, small group discussions, and educational events centering on the theme of men helping their male friends avoid risk. Venues were randomized into 12 control versus 12 intervention beer halls with little cross-contamination between study arms. The penetration and impact of the intervention were assessed by pre- and post-intervention cross-sectional surveys of the beer hall patronage. The intervention was implemented with a high degree of fidelity to the protocol, with exposure to the intervention activities significantly higher among intervention patrons compared to control. While we found generally declining levels of risk behavior in both study arms from baseline to post-intervention, we found no evidence of an impact of the intervention on our primary outcome measure: episodes of unprotected sex with non-wife partners in the preceding 6 months (median 5.4 episodes for men at intervention beer halls vs. 5.1 among controls, P = 0.98). There was also no evidence that the intervention reduced other risks for HIV. It remains an imperative to find ways to productively engage men in AIDS prevention, especially in those venues where male bonding, alcohol consumption

  1. The Cost-Effectiveness of Wound-Edge Protection Devices Compared to Standard Care in Reducing Surgical Site Infection after Laparotomy: An Economic Evaluation alongside the ROSSINI Trial

    PubMed Central

    Gheorghe, Adrian; Roberts, Tracy E.; Pinkney, Thomas D.; Bartlett, David C.; Morton, Dion; Calvert, Melanie

    2014-01-01

    Background Wound-edge protection devices (WEPDs) have been used in surgery for more than 40 years to reduce surgical site infection (SSI). No economic evaluation of WEPDs against any comparator has ever been conducted. The aim of the paper was to assess whether WEPDs are cost-effective in reducing SSI compared to standard care alone in the United Kingdom. Methods and Findings An economic evaluation was conducted alongside the ROSSINI trial. The study perspective was that of the UK National Health Service and the time horizon was 30 days post-operatively. The study was conducted in 21 UK hospitals. 760 patients undergoing laparotomy were randomised to either WEPD or standard care and 735 were included in the primary analysis. The main economic outcome was cost-effectiveness based on incremental cost (£) per quality adjusted life year (QALY) gained. Patients in the WEPD arm accessed health care worth £5,420 on average and gained 0.02131 QALYs, compared to £5,130 and 0.02133 QALYs gained in the standard care arm. The WEPD strategy was more costly and equally effective compared to standard care, but there was significant uncertainty around incremental costs and QALYs. The findings were robust to a range of sensitivity analyses. Conclusions There is no evidence to suggest that WEPDs can be considered a cost effective device to reduce SSI. Their continued use is a waste of limited health care resources. PMID:24748154

  2. Re-Assessing Green Building Performance: A Post Occupancy Evaluation of 22 GSA Buildings

    SciTech Connect

    Fowler, Kimberly M.; Rauch, Emily M.; Henderson, Jordan W.; Kora, Angela R.

    2010-06-01

    2nd report on the performance of GSA's sustainably designed buildings. The purpose of this study was to provide an overview of measured whole building performance as it compares to GSA and industry baselines. The PNNL research team found the data analysis illuminated strengths and weaknesses of individual buildings as well as the portfolio of buildings. This section includes summary data, observations that cross multiple performance metrics, discussion of lessons learned from this research, and opportunities for future research. The summary of annual data for each of the performance metrics is provided in Table 25. The data represent 1 year of measurements and are not associated with any specific design features or strategies. Where available, multiple years of data were examined and there were minimal significant differences between the years. Individually focused post occupancy evaluation (POEs) would allow for more detailed analysis of the buildings. Examining building performance over multiple years could potentially offer a useful diagnostic tool for identifying building operations that are in need of operational changes. Investigating what the connection is between the building performance and the design intent would offer potential design guidance and possible insight into building operation strategies. The 'aggregate operating cost' metric used in this study represents the costs that were available for developing a comparative industry baseline for office buildings. The costs include water utilities, energy utilities, general maintenance, grounds maintenance, waste and recycling, and janitorial costs. Three of the buildings that cost more than the baseline in Figure 45 have higher maintenance costs than the baseline, and one has higher energy costs. Given the volume of data collected and analyzed for this study, the inevitable request is for a simple answer with respect to sustainably designed building performance. As previously stated, compiling the

  3. An evaluation of process and outcomes from learning through reflective practice groups on a post-registration nursing course.

    PubMed

    Platzer, H; Blake, D; Ashford, D

    2000-03-01

    An evaluation of process and outcomes from learning through reflective practice groups on a post-registration nursing course Small groups were set up purposefully on a part-time post-registration Diploma in Professional Studies in Nursing programme to enable students to reflect on and learn from experience. The use of these groups was qualitatively evaluated by the use of in-depth interviews. Although there were many barriers to such learning, some students made significant developments in their critical thinking ability and underwent perspective transformations that led to changes in attitudes and behaviour. These are identified as an increased professionalism, greater autonomy in decision making, more self-confidence to challenge the status quo and make their own judgements, and a less rule-bound approach to their practice. The processes by which these changes occurred are identified as support and challenge within the groups offered by both the facilitators and other group members.

  4. [Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

    PubMed

    Xiao, Ying; Zhao, Yubin; Xie, Yanming

    2011-10-01

    The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

  5. Plant Line Trial Evaluation of Viable Non-Chromium Passivation Systems for Electrolytin Tinplate, ETP (TRP 9911)

    SciTech Connect

    John A. Sinsel

    2003-06-30

    Plant trial evaluations have been completed for two zirconium-based, non-chromium passivation systems previously identified as possible alternatives to cathodic dichromate (CDC) passivation for electrolytic tinplate (ETP). These trials were done on a commercial electrolytic tin plating line at Weirton Steel and extensive evaluations of the materials resulting from these trials have been completed. All this was accomplished as a collaborative effort under the AISI Technology Roadmap Program and was executed by seven North American Tin Mill Products producers [Bethlehem Steel (now acquired by International Steel Group (ISG)), Dofasco Inc., National Steel (now acquired by U.S. Steel), U.S. Steel, USS-Posco, Weirton Steel, and Wheeling-Pittsburgh Steel] with funding partially from the Department of Energy (DOE) and partially on an equal cost sharing basis among project participants. The initial phases of this project involved optimization of application procedures for the non-chromium systems in the laboratories at Bethlehem Steel and Betz Dearborn followed by extensive testing with various lacquer formulations and food simulants in the laboratories at Valspar and PPG. Work was also completed at Dofasco and Weirton Steel to develop methods to prevent precipitation of insoluble solids as a function of time from the zirconate system. The results of this testing indicated that sulfide staining characteristics for the non-chromium passivation systems could be minimized but not totally eliminated and neither system was found to perform quite as good, in this respect, as the standard CDC system. As for the stability of zirconate treatment, a method was developed to stabilize this system for a sufficient period of time to conduct plant trial evaluations but, working with a major supplier of zirconium orthosulfate, a method for long term stabilization is still under development.

  6. Joint protection and hand exercises for hand osteoarthritis: an economic evaluation comparing methods for the analysis of factorial trials

    PubMed Central

    Oppong, Raymond; Nicholls, Elaine; Whitehurst, David G. T.; Hill, Susan; Hammond, Alison; Hay, Elaine M.; Dziedzic, Krysia

    2015-01-01

    Objectives. Evidence regarding the cost-effectiveness of joint protection and hand exercises for the management of hand OA is not well established. The primary aim of this study is to assess the cost-effectiveness (cost-utility) of these management options. In addition, given the absence of consensus regarding the conduct of economic evaluation alongside factorial trials, we compare different analytical methodologies. Methods. A trial-based economic evaluation to assess the cost-utility of joint protection only, hand exercises only and joint protection plus hand exercises compared with leaflet and advice was undertaken over a 12 month period from a UK National Health Service perspective. Patient-level mean costs and mean quality-adjusted life years (QALYs) were calculated for each trial arm. Incremental cost-effectiveness ratios (ICERs) were estimated and cost-effectiveness acceptability curves were constructed. The base case analysis used a within-the-table analysis methodology. Two further methods were explored: the at-the-margins approach and a regression-based approach with or without an interaction term. Results. Mean costs (QALYs) were £58.46 (s.d. 0.662) for leaflet and advice, £92.12 (s.d. 0.659) for joint protection, £64.51 (s.d. 0.681) for hand exercises and £112.38 (s.d. 0.658) for joint protection plus hand exercises. In the base case, hand exercises were the cost-effective option, with an ICER of £318 per QALY gained. Hand exercises remained the most cost-effective management strategy when adopting alternative methodological approaches. Conclusion. This is the first trial evaluating the cost-effectiveness of occupational therapy-supported approaches to self-management for hand OA. Our findings showed that hand exercises were the most cost-effective option. PMID:25339642

  7. Theory-Driven Process Evaluation of the SHINE Trial Using a Program Impact Pathway Approach

    PubMed Central

    Mbuya, Mduduzi N. N.; Jones, Andrew D.; Ntozini, Robert; Humphrey, Jean H.; Moulton, Lawrence H.; Stoltzfus, Rebecca J.; Maluccio, John A.

    2015-01-01

    Two reasons for the lack of success of programs or interventions are poor alignment of interventions with the causes of the problem targeted by the intervention, leading to poor efficacy (theory failure), and failure to implement interventions as designed (program failure). These failures are important for both public health programs and randomized trials. In the Sanitation Hygiene and Infant Nutrition Efficacy (SHINE) Trial, we utilize the program impact pathway (PIP) approach to track intervention implementation and behavior uptake. In this article, we present the SHINE PIP including definitions and measurements of key mediating domains, and discuss the implications of this approach for randomized trials. Operationally, the PIP can be used for monitoring and strengthening intervention delivery, facilitating course-correction at various stages of implementation. Analytically, the PIP can facilitate a richer understanding of the mediating and modifying determinants of intervention impact than would be possible from an intention-to-treat analysis alone. PMID:26602304

  8. Identifying MRI markers to evaluate early treatment-related changes post-laser ablation for cancer pain management

    NASA Astrophysics Data System (ADS)

    Tiwari, Pallavi; Danish, Shabbar; Madabhushi, Anant

    2014-03-01

    Laser interstitial thermal therapy (LITT) has recently emerged as a new treatment modality for cancer pain management that targets the cingulum (pain center in the brain), and has shown promise over radio-frequency (RF) based ablation which is reported to provide temporary relief. One of the major advantages enjoyed by LITT is its compatibility with magnetic resonance imaging (MRI), allowing for high resolution in vivo imaging to be used in LITT procedures. Since laser ablation for pain management is currently exploratory and is only performed at a few centers worldwide, its short-, and long-term effects on the cingulum are currently unknown. Traditionally treatment effects are evaluated by monitoring changes in volume of the ablation zone post-treatment. However, this is sub-optimal since it involves evaluating a single global parameter (volume) to detect changes pre-, and post-MRI. Additionally, the qualitative observations of LITT-related changes on multi-parametric MRI (MPMRI) do not specifically address differentiation between the appearance of treatment related changes (edema, necrosis) from recurrence of the disease (pain recurrence). In this work, we explore the utility of computer extracted texture descriptors on MP-MRI to capture early treatment related changes on a per-voxel basis by extracting quantitative relationships that may allow for an in-depth understanding of tissue response to LITT on MRI, subtle changes that may not be appreciable on original MR intensities. The second objective of this work is to investigate the efficacy of different MRI protocols in accurately capturing treatment related changes within and outside the ablation zone post-LITT. A retrospective cohort of studies comprising pre- and 24-hour post-LITT 3 Tesla T1-weighted (T1w), T2w, T2-GRE, and T2-FLAIR acquisitions was considered. Our scheme involved (1) inter-protocol as well as inter-acquisition affine registration of pre- and post-LITT MRI, (2) quantitation of MRI parameters

  9. An Evaluation and Redesign of the Conflict Prediction and Trial Planning Planview Graphical User Interface

    NASA Technical Reports Server (NTRS)

    Laudeman, Irene V.; Brasil, Connie L.; Stassart, Philippe

    1998-01-01

    The Planview Graphical User Interface (PGUI) is the primary display of air traffic for the Conflict Prediction and Trial Planning, function of the Center TRACON Automation System. The PGUI displays air traffic information that assists the user in making decisions related to conflict detection, conflict resolution, and traffic flow management. The intent of this document is to outline the human factors issues related to the design of the conflict prediction and trial planning portions of the PGUI, document all human factors related design changes made to the PGUI from December 1996 to September 1997, and outline future plans for the ongoing PGUI design.

  10. Evaluation of Dual-Launch Lunar Architectures Using the Mission Assessment Post Processor

    NASA Technical Reports Server (NTRS)

    Stewart, Shaun M.; Senent, Juan; Williams, Jacob; Condon, Gerald L.; Lee, David E.

    2010-01-01

    The National Aeronautics and Space Administrations (NASA) Constellation Program is currently designing a new transportation system to replace the Space Shuttle, support human missions to both the International Space Station (ISS) and the Moon, and enable the eventual establishment of an outpost on the lunar surface. The present Constellation architecture is designed to meet nominal capability requirements and provide flexibility sufficient for handling a host of contingency scenarios including (but not limited to) launch delays at the Earth. This report summarizes a body of work performed in support of the Review of U.S. Human Space Flight Committee. It analyzes three lunar orbit rendezvous dual-launch architecture options which incorporate differing methodologies for mitigating the effects of launch delays at the Earth. NASA employed the recently-developed Mission Assessment Post Processor (MAPP) tool to quickly evaluate vehicle performance requirements for several candidate approaches for conducting human missions to the Moon. The MAPP tool enabled analysis of Earth perturbation effects and Earth-Moon geometry effects on the integrated vehicle performance as it varies over the 18.6-year lunar nodal cycle. Results are provided summarizing best-case and worst-case vehicle propellant requirements for each architecture option. Additionally, the associated vehicle payload mass requirements at launch are compared between each architecture and against those of the Constellation Program. The current Constellation Program architecture assumes that the Altair lunar lander and Earth Departure Stage (EDS) vehicles are launched on a heavy lift launch vehicle. The Orion Crew Exploration Vehicle (CEV) is separately launched on a smaller man-rated vehicle. This strategy relaxes man-rating requirements for the heavy lift launch vehicle and has the potential to significantly reduce the cost of the overall architecture over the operational lifetime of the program. The crew launch

  11. Evaluation of Retention of two Different Cast Post-Core Systems and Fracture Resistance of the Restored Teeth

    PubMed Central

    Khaledi, Amir Ali Reza; Sheykhian, Shekufe; Khodaei, Arash

    2015-01-01

    Statement of the Problem The survival of pulpless teeth restored with different post and core systems is still a controversial issue. Purpose This study compared the retention of two different post and core systems and also the fracture resistance of teeth restored with these systems. Material and Method Eighty endodontically treated maxillary central incisors were sectioned perpendicular to the long axis at a point 2mm incisal to the cemento-enamel junction (CEJ) and then the root canals were obturated. The restored teeth were randomly divided into two equal groups of 40. One group was restored with Nickel-Chromium (Ni-Cr) post and core system and the other group with Non-Precious Gold alloy (NPG) system. For evaluation of fracture resistance of the restored teeth, the specimens (n=20 per each group) were mounted in acrylic resin blocks and a layer of polyvinyl siloxane was applied to cover the roots. Loads were applied at an angle of 45 degrees to the long axis of the teeth and measured with a universal testing machine. The axial retention values of the studied groups (no=20) were measured on an Instron testing machine at a crosshead speed of 0.5 mm/min. Statistical analyses were performed using SPSS version 19.00 and student’s t-test (α=0.05). Results Although retention failure load for Ni-Cr system was lower than NPG system, there was no significant difference between the two systems (p= 0.7). However, fracture resistance of the teeth restored with Ni-Cr post and core system was significantly higher than NPG group (p= 0.000). Conclusion There was no significant difference between the retention of the studied post and core systems. Although significantly higher fracture thresholds were recorded for Ni-Cr post and core group, the failure loads of both systems may rarely occur clinically. PMID:26046108

  12. Optimizing the Scientific Yield from a Randomized Controlled Trial (RCT): Evaluating Two Behavioral Interventions and Assessment Reactivity with a Single Trial

    PubMed Central

    Carey, Michael P.; Senn, Theresa E.; Coury-Doniger, Patricia; Urban, Marguerite A.; Vanable, Peter A.; Carey, Kate B.

    2013-01-01

    Randomized controlled trials (RCTs) remain the gold standard for evaluating intervention efficacy but are often costly. To optimize their scientific yield, RCTs can be designed to investigate multiple research questions. This paper describes an RCT that used a modified Solomon four-group design to simultaneously evaluate two, theoretically-guided, health promotion interventions as well as assessment reactivity. Recruited participants (N = 1010; 56% male; 69% African American) were randomly assigned to one of four conditions formed by crossing two intervention conditions (i.e., general health promotion vs. sexual risk reduction intervention) with two assessment conditions (i.e., general health vs. sexual health survey). After completing their assigned baseline assessment, participants received the assigned intervention, and returned for follow-ups at 3, 6, 9, and 12 months. In this report, we summarize baseline data, which show high levels of sexual risk behavior; alcohol, marijuana, and tobacco use; and fast food consumption. Sexual risk behaviors and substance use were correlated. Participants reported high satisfaction with both interventions but ratings for the sexual risk reduction intervention were higher. Planned follow-up sessions, and subsequent analyses, will assess changes in health behaviors including sexual risk behaviors. This study design demonstrates one way to optimize the scientific yield of an RCT. PMID:23816489

  13. Tuning the light in senior care: Evaluating a trial LED lighting system at the ACC Care Center in Sacramento, CA

    SciTech Connect

    Davis, Robert G.; Wilkerson, Andrea M.

    2016-08-31

    This report summarizes the results from a trial installation of light-emitting diode (LED) lighting systems in several spaces within the ACC Care Center in Sacramento, CA. The Sacramento Municipal Utility District (SMUD) coordinated the project and invited the U.S. Department of Energy (DOE) to document the performance of the LED lighting systems as part of a GATEWAY evaluation. DOE tasked the Pacific Northwest National Laboratory (PNNL) to conduct the investigation. SMUD and ACC staff coordinated and completed the design and installation of the LED systems, while PNNL and SMUD staff evaluated the photometric performance of the systems. ACC staff also track behavioral and health measures of the residents; some of those results are reported here, although PNNL staff were not directly involved in collecting or interpreting those data. The trial installation took place in a double resident room and a single resident room, and the corridor that connects those (and other) rooms to the central nurse station. Other spaces in the trial included the nurse station, a common room called the family room located near the nurse station, and the ACC administrator’s private office.

  14. Protocol to evaluate the impact of yoga supplementation on cognitive function in schizophrenia: a randomised controlled trial

    PubMed Central

    Bhatia, Triptish; Mazumdar, Sati; Mishra, Nagendra Narayan; Gur, Raquel E.; Gur, Ruben C.; Nimgaonkar, Vishwajit Laxmikant; Deshpande, Smita Neelkanth

    2015-01-01

    Background Schizophrenia (SZ) is a chronic illness that is treated symptomatically. Cognitive dysfunction is a core feature of SZ that is relatively intractable to pharmacotherapy. Yoga can improve cognitive function among healthy individuals. A recent open trial indicated significant benefits of yoga training (YT) in conjunction with conventional pharmacotherapy among patients with SZ. Aims To describe the protocol for an ongoing randomised controlled trial designed to test whether the reported beneficial effects of YT on cognitive function among SZ patients can be replicated. Secondarily, the effects of YT on daily functioning living skills are evaluated. Methods Consenting patients with SZ receive routine clinical treatment and are randomised to adjunctive YT, adjunctive physical exercise (PE) or treatment as usual (proposed N = 234 total, N = 78 in each group). The trial involves YT or PE 5 days a week and lasts 3 weeks. Participants are evaluated thrice over 6 months. Cognitive functions measured by Trail Making Test, University of Pennsylvania Neurocognitive Computerised Battery were primary outcome measures while clinical severity and daily functioning measured by Independent Living Skills Survey were secondary outcome measures. Results A total of 309 participants have been randomised as of 31 August 2013, which exceeded beyond 294 proposed after attrition. Once participants begin YT or PE they generally complete the protocol. No injuries have been reported. Conclusions Short term YT is feasible and acceptable to Indian SZ patients. If beneficial effects of YT are detected, it will provide a novel adjunctive cognitive remediation strategy for SZ patients. PMID:25241756

  15. Comparative Evaluation of the Reinforcing Effect of Different Post Systems in the Restoration of Endodontically Treated Human Anterior Teeth at Two Different Lengths of Post Space Preparation- An in Vitro Study

    PubMed Central

    Jindal, Sahil; Jindal, Ritu; Gupta, Kanika; Mahajan, Sandeep; Garg, Sunidhi

    2013-01-01

    Objectives: Comparative evaluation of the reinforcing effect of different post systems in the restoration of endodontically treated human anterior teeth at two different lengths of post space preparation- an in vitro study Materials and Methods: 135 extracted human incisors were endodontically treated, out of which 120 teeth were decoronated 2mm above the cementoenamel junction and divided into four experimental groups based on the post system to be used: Glass fiber post (GFP) and stainless steel post (SSP), titanium post (TTP), cast metal post (CMP). Each group was divided into two sub-groups according to the length of post space preparation: 5mm and 10mm. All the samples were restored with metal crowns. The fracture resistance was measured by applying loads at an angle of 135º to the long axis of teeth in an instron universal testing machine. Fracture mode was analyzed for all the samples. Results from the four test groups were compared and analysed using one-way ANOVA test and the Post-hoc Bonferroni test to demonstrate differences between pairs of groups. Results: The results revealed that SSP group at 10mm post space length showed the significantly (“P-value< 0.05”) highest fracture resistance (793.7787 N). Decrease in post length resulted in the decrease in fracture resistance in all the groups reduced to values even lesser than the control (437.8733N). Conclusion: The different post systems used in the study were able to reinforce endodontically treated teeth only at 10mm post space length. PMID:23724211

  16. Field efficacy evaluation and post-treatment contamination risk assessment of an ultraviolet disinfection and safe storage system.

    PubMed

    Reygadas, Fermin; Gruber, Joshua S; Ray, Isha; Nelson, Kara L

    2015-11-15

    Inconsistent use of household water treatment and safe storage (HWTS) systems reduces their potential health benefits. Ultraviolet (UV) disinfection is more convenient than some existing HWTS systems, but it does not provide post-treatment residual disinfectant, which could leave drinking water vulnerable to recontamination. In this paper, using as-treated analyses, we report on the field efficacy of a UV disinfection system at improving household drinking water quality in rural Mexico. We further assess the risk of post-treatment contamination from the UV system, and develop a process-based model to better understand household risk factors for recontamination. This study was part of a larger cluster-randomized stepped wedge trial, and the results complement previously published population-level results of the intervention on diarrheal prevalence and water quality. Based on the presence of Escherichia coli (proportion of households with ≥ 1 E. coli/100 mL), we estimated a risk difference of -28.0% (95% confidence interval (CI): -33.9%, -22.1%) when comparing intervention to control households; -38.6% (CI: -48.9%, -28.2%) when comparing post- and pre-int