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Sample records for high quality trial

  1. Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis.

    Science.gov (United States)

    Hays, Meredith; Andrews, Mary; Wilson, Ramey; Callender, David; O'Malley, Patrick G; Douglas, Kevin

    2016-07-28

    The aim of this study was to assess adherence to the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts by five high-impact general medical journals and to assess whether the quality of reporting was homogeneous across these journals. This is a descriptive, cross-sectional study. Randomised controlled trial (RCT) abstracts in five high-impact general medical journals. We used up to 100 RCT abstracts published between 2011 and 2014 from each of the following journals: The New England Journal of Medicine (NEJM), the Annals of Internal Medicine (Annals IM), The Lancet, the British Medical Journal (The BMJ) and the Journal of the American Medical Association (JAMA). The primary outcome was per cent overall adherence to the 19-item CONSORT for Abstracts checklist. Secondary outcomes included per cent adherence in checklist subcategories and assessing homogeneity of reporting quality across the individual journals. Search results yielded 466 abstracts, 3 of which were later excluded as they were not RCTs. Analysis was performed on 463 abstracts (97 from NEJM, 66 from Annals IM, 100 from The Lancet, 100 from The BMJ, 100 from JAMA). Analysis of all scored items showed an overall adherence of 67% (95% CI 66% to 68%) to the CONSORT for Abstracts checklist. The Lancet had the highest overall adherence rate (78%; 95% CI 76% to 80%), whereas NEJM had the lowest (55%; 95% CI 53% to 57%). Adherence rates to 8 of the checklist items differed by >25% between journals. Among the five highest impact general medical journals, there is variable and incomplete adherence to the CONSORT for Abstracts reporting checklist of randomised trials, with substantial differences between individual journals. Lack of adherence to the CONSORT for Abstracts reporting checklist by high-impact medical journals impedes critical appraisal of important studies. We recommend diligent assessment of adherence to reporting guidelines by authors, reviewers and editors to promote transparency

  2. Quality Assurance for Clinical Trials

    Science.gov (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  3. Effect of Promoting High-Quality Staff Interactions on Fall Prevention in Nursing Homes: A Cluster-Randomized Trial.

    Science.gov (United States)

    Colón-Emeric, Cathleen S; Corazzini, Kirsten; McConnell, Eleanor S; Pan, Wei; Toles, Mark; Hall, Rasheeda; Cary, Michael P; Batchelor-Murphy, Melissa; Yap, Tracey; Anderson, Amber L; Burd, Andrew; Amarasekara, Sathya; Anderson, Ruth A

    2017-11-01

    New approaches are needed to enhance implementation of complex interventions for geriatric syndromes such as falls. To test whether a complexity science-based staff training intervention (CONNECT) promoting high-quality staff interactions improves the impact of an evidence-based falls quality improvement program (FALLS). Cluster-randomized trial in 24 nursing homes receiving either CONNECT followed by FALLS (intervention), or FALLS alone (control). Nursing home staff in all positions were asked to complete surveys at baseline, 3, 6, and 9 months. Medical records of residents with at least 1 fall in the 6-month pre- and postintervention windows (n = 1794) were abstracted for fall risk reduction measures, falls, and injurious falls. CONNECT taught staff to improve their connections with coworkers, increase information flow, and use cognitive diversity in problem solving. Intervention components included 2 classroom sessions, relationship mapping, and self-monitoring. FALLS provided instruction in the Agency for Healthcare Research and Quality's Falls Management Program. Primary outcomes were (1) mean number of fall risk reduction activities documented within 30 days of falls and (2) median fall rates among residents with at least 1 fall during the study period. In addition, validated scales measured staff communication quality, frequency, timeliness, and safety climate. Surveys were completed by 1545 staff members, representing 734 (37%) and 811 (44%) of eligible staff in intervention and control facilities, respectively; 511 (33%) respondents were hands-on care workers. Neither the CONNECT nor the FALLS-only facilities improved the mean count of fall risk reduction activities following FALLS (3.3 [1.6] vs 3.2 [1.5] of 10); furthermore, adjusted median recurrent fall rates did not differ between the groups (4.06 [interquartile range {IQR}, 2.03-8.11] vs 4.06 [IQR, 2.04-8.11] falls/resident/y). A modest improvement in staff communication measures was observed

  4. Average effect estimates remain similar as evidence evolves from single trials to high-quality bodies of evidence: a meta-epidemiologic study.

    Science.gov (United States)

    Gartlehner, Gerald; Dobrescu, Andreea; Evans, Tammeka Swinson; Thaler, Kylie; Nussbaumer, Barbara; Sommer, Isolde; Lohr, Kathleen N

    2016-01-01

    The objective of our study was to use a diverse sample of medical interventions to assess empirically whether first trials rendered substantially different treatment effect estimates than reliable, high-quality bodies of evidence. We used a meta-epidemiologic study design using 100 randomly selected bodies of evidence from Cochrane reports that had been graded as high quality of evidence. To determine the concordance of effect estimates between first and subsequent trials, we applied both quantitative and qualitative approaches. For quantitative assessment, we used Lin's concordance correlation and calculated z-scores; to determine the magnitude of differences of treatment effects, we calculated standardized mean differences (SMDs) and ratios of relative risks. We determined qualitative concordance based on a two-tiered approach incorporating changes in statistical significance and magnitude of effect. First trials both overestimated and underestimated the true treatment effects in no discernible pattern. Nevertheless, depending on the definition of concordance, effect estimates of first trials were concordant with pooled subsequent studies in at least 33% but up to 50% of comparisons. The pooled magnitude of change as bodies of evidence advanced from single trials to high-quality bodies of evidence was 0.16 SMD [95% confidence interval (CI): 0.12, 0.21]. In 80% of comparisons, the difference in effect estimates was smaller than 0.5 SMDs. In first trials with large treatment effects (>0.5 SMD), however, estimates of effect substantially changed as new evidence accrued (mean change 0.68 SMD; 95% CI: 0.50, 0.86). Results of first trials often change, but the magnitude of change, on average, is small. Exceptions are first trials that present large treatment effects, which often dissipate as new evidence accrues. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation.

    Science.gov (United States)

    Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S

    2016-01-01

    Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.

  6. A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

    Science.gov (United States)

    Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

    2016-01-01

    Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

  7. Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals.

    Science.gov (United States)

    Ghimire, Saurav; Kyung, Eunjung; Kang, Wonku; Kim, Eunyoung

    2012-06-07

    The extended Consolidated Standards of Reporting Trials (CONSORT) Statement for Abstracts was developed to improve the quality of reports of randomized controlled trials (RCTs) because readers often base their assessment of a trial solely on the abstract. To date, few data exist regarding whether it has achieved this goal. We evaluated the extent of adherence to the CONSORT for Abstract statement for quality of reports on RCT abstracts by four high-impact general medical journals. A descriptive analysis of published RCT abstracts in The New England Journal of Medicine (NEJM), The Lancet, The Journal of American Medical Association (JAMA), and the British Medical Journal (BMJ) in the year 2010 was conducted by two reviewers, independently extracting data from a MEDLINE/PubMed search. We identified 271 potential RCT abstracts meeting our inclusion criteria. More than half of the abstracts identified the study as randomized in the title (58.7%; 159/271), reported the specific objective/hypothesis (72.7%; 197/271), described participant eligibility criteria with settings for data collection (60.9%; 165/271), detailed the interventions for both groups (90.8%; 246/271), and clearly defined the primary outcome (94.8%; 257/271). However, the methodological quality domains were inadequately reported: allocation concealment (11.8%; 32/271) and details of blinding (21.0%; 57/271). Reporting the primary outcome results for each group was done in 84.1% (228/271). Almost all of the abstracts reported trial registration (99.3%; 269/271), whereas reports of funding and of harm or side effects from the interventions were found in only 47.6% (129/271) and 42.8% (116/271) of the abstracts, respectively. These findings show inconsistencies and non-adherence to the CONSORT for abstract guidelines, especially in the methodological quality domains. Improvements in the quality of RCT reports can be expected by adhering to existing standards and guidelines as expressed by the CONSORT group.

  8. Quality of clinical trials: A moving target

    Science.gov (United States)

    Bhatt, Arun

    2011-01-01

    Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

  9. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  10. Quality assurance of asthma clinical trials.

    Science.gov (United States)

    Malmstrom, Kerstin; Peszek, Iza; Al Botto; Lu, Susan; Enright, Paul L; Reiss, Theodore F

    2002-04-01

    Accuracy and repeatability of spirometry measurements are essential to obtain reliable efficacy data in randomized asthma clinical trials. We report our experience with a centralized spirometry quality assurance program that we implemented in our phase III asthma trials. Six asthma trials of 4 to 21 weeks in duration were conducted at 232 clinical centers in 31 countries. Approximately 23,100 prebronchodilator and 13,700 postbronchodilator spirometry tests were collected from 2523 adult and 336 pediatric asthmatic patients. The program used a standard spirometer (the Renaissance spirometry system) with maneuver quality messages and automated quality grading of the spirometry tests. Each clinical center transmitted spirometry data weekly to a central database, where uniform monitoring of data quality was performed and feedback was provided in weekly quality reports. Seventy-nine percent of all patients performed spirometry sessions with quality that either met or exceeded American Thoracic Society standards and improved over time. Good-quality spirometry was associated with (1) less severe asthma; (2) active treatment; (3) infrequent nocturnal awakenings; (4) age above 15 years; and (5) low body weight. Maneuver-induced bronchospasm was rare. Good-quality spirometry was observed in multicenter asthma clinical trials that employed a standard spirometer and continuous monitoring. Both within- and between-patient variability decreased. Spirometry quality improved with time as study participants and technicians gained experience.

  11. The effect of high-dose vitamin D supplementation on muscular function and quality of life in postmenopausal women-A randomized controlled trial.

    Science.gov (United States)

    Grimnes, G; Emaus, N; Cashman, K D; Jorde, R

    2017-07-01

    Observational studies have suggested positive associations between serum 25-hydroxyvitamin D (25(OH)D) levels and muscular strength, balance and quality of life. Our aim was to examine whether high-dose vitamin D supplementation would improve these measures as compared to standard-dose vitamin D, as well as the possible muscular effects of single nucleotide polymorphisms (SNPs) in genes encoding vitamin D-related enzymes. A 12-month randomized, double-blind, controlled trial where the participants received daily elemental calcium (1000 mg) plus vitamin D 3 (800 IU). In addition, the participants were randomized to receive either capsules with vitamin D 3 (20 000 IU) or matching placebos to be taken twice a week. A total of 297 postmenopausal women with osteopenia or osteoporosis. Muscle strength (handgrip and knee extensor strength), balance (tandem test) and quality of life (EQ-5D) were measured at baseline and after 12 months. The subjects were genotyped for SNPs related to vitamin D metabolism. Of the 297 included women, 275 completed the study. Mean serum 25(OH)D levels dramatically increased in the high-dose group (from 64.7 to 164.1 nmol/L; PD had no effect on muscular strength, balance or quality of life in postmenopausal women with osteopenia or osteoporosis as compared to standard dose. The association between rs3829251 and muscle strength needs confirmation in other populations. © 2017 John Wiley & Sons Ltd.

  12. Health related quality of life in locally advanced NSCLC treated with high dose radiotherapy and concurrent chemotherapy or cetuximab – Pooled results from two prospective clinical trials

    International Nuclear Information System (INIS)

    Hallqvist, Andreas; Bergman, Bengt; Nyman, Jan

    2012-01-01

    Background: In non-small cell lung cancer (NSCLC) stage III, data on patient reported health-related quality of life (HRQL) are scarce, especially regarding concurrent chemoradiotherapy. Aims: To evaluate HRQL in patients treated with high dose radiotherapy combined with concurrent chemotherapy or the antibody cetuximab. Methods: The study population comprised all patients enroled in either of two phase II trials in locally advanced NSCLC performed in Sweden 2002–2007. The RAKET trial investigated three different ways of increasing local control (accelerated hyperfractionated treatment or concurrent daily or weekly chemotherapy). The Satellite trial evaluated the addition of cetuximab to thoracic irradiation. HRQL was measured at four time points: At baseline, before radiotherapy, 4–6 weeks after radiotherapy and at 3 months follow-up, using the EORTC QLQ-C30 and LC14 set of questionnaires. Results: 154/220 patients (65%) who completed HRQL assessments at all time points were included in the longitudinal study. There was a significant decline over time regarding most functioning measures. Dyspnoea and fatigue gradually deteriorated without recovery after completed treatment. Chemotherapy related symptoms showed a transient deterioration, whereas radiotherapy related esophagitis had not fully recovered at 3 months. Patients with stage IIIA disease tended to recover better regarding global QL, fatigue and dyspnoea compared to patients with stage IIIB. Patients with WHO performance status (PS) 0 reported improved global QL and less fatigue over time compared with PS 1. Concurrent chemotherapy was associated with more pronounced fatigue and dysphagia, and worse global QL compared with concurrent cetuximab. Baseline physical functioning was an independent predictor of overall survival. Conclusion: Patients undergoing high dose thoracic radiotherapy combined with chemotherapy or cetuximab reported a gradual deterioration in functioning, dyspnoea and fatigue, while

  13. Industry funded clinical trials: bias and quality.

    Science.gov (United States)

    Del Parigi, Angelo

    2012-01-01

    The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

  14. [Clinical trial data management and quality metrics system].

    Science.gov (United States)

    Chen, Zhao-hua; Huang, Qin; Deng, Ya-zhong; Zhang, Yue; Xu, Yu; Yu, Hao; Liu, Zong-fan

    2015-11-01

    Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

  15. Clinical trial quality: From supervision to collaboration and beyond.

    Science.gov (United States)

    Meeker-O'Connell, Ann; Glessner, Coleen

    2018-02-01

    Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

  16. A randomized hypofractionation dose escalation trial for high risk prostate cancer patients: interim analysis of acute toxicity and quality of life in 124 patients

    International Nuclear Information System (INIS)

    Norkus, Darius; Valuckas, Konstantinas Povilas; Karklelyte, Agata; Engels, Benedikt; Versmessen, Harijati; Griskevicius, Romas; De Ridder, Mark; Storme, Guy; Aleknavicius, Eduardas; Janulionis, Ernestas

    2013-01-01

    The α/β ratio for prostate cancer is postulated being in the range of 0.8 to 2.2 Gy, giving rise to the hypothesis that there may be a therapeutic advantage to hypofractionation. To do so, we carried out a randomized trial comparing hypofractionated and conventionally fractionated image-guided intensity modulated radiotherapy (IG-IMRT) in high-risk prostate cancer. Here, we report on acute toxicity and quality of life (QOL) for the first 124 randomized patients. The trial compares 76 Gy in 38 fractions (5 fractions/week) (Arm 1) to 63 Gy in 20 fractions (4 fractions/week) (Arm 2) (IG-IMRT). Prophylactic pelvic lymph node irradiation with 46 Gy in 23 fractions sequentially (Arm 1) and 44 Gy in 20 fractions simultaneously (Arm 2) was applied. All patients had long term androgen deprivation therapy (ADT) started before RT. Both physician-rated acute toxicity and patient-reported QOL using EPIC questionnaire are described. There were no differences in overall maximum acute gastrointestinal (GI) or genitourinary (GU) toxicity. Compared to conventional fractionation (Arm 1), GI and GU toxicity both developed significantly earlier but also disappeared earlier in the Arm 2, reaching significant differences from Arm 1 at week 8 and 9. In multivariate analyses, only parameter shown to be related to increased acute Grade ≥1 GU toxicity was the study Arm 2 (p = 0.049). There were no statistically significant differences of mean EPIC scores in any domain and sub-scales. The clinically relevant decrease (CRD) in EPIC urinary domain was significantly higher in Arm 2 at month 1 with a faster recovery at month 3 as compared to Arm 1. Hypofractionation at 3.15 Gy per fraction to 63 Gy within 5 weeks was well tolerated. The GI and GU physician-rated acute toxicity both developed earlier but recovered faster using hypofractionation. There was a correlation between acute toxicity and bowel and urinary QOL outcomes. Longer follow-up is needed to determine the significance of these

  17. A Prospective Longitudinal Clinical Trial Evaluating Quality of Life After Breast-Conserving Surgery and High-Dose-Rate Interstitial Brachytherapy for Early-Stage Breast Cancer

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    Garsa, Adam A.; Ferraro, Daniel J.; DeWees, Todd A. [Department of Radiation Oncology, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Deshields, Teresa L. [Department of Medicine, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Margenthaler, Julie A.; Cyr, Amy E. [Department of Surgery, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Naughton, Michael [Department of Medicine, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Aft, Rebecca [Department of Surgery, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Department of Surgery, John Cochran Veterans Hospital, St. Louis, Missouri (United States); Gillanders, William E.; Eberlein, Timothy [Department of Surgery, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Matesa, Melissa A.; Ochoa, Laura L. [Department of Radiation Oncology, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Zoberi, Imran, E-mail: izoberi@radonc.wustl.edu [Department of Radiation Oncology, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States)

    2013-12-01

    Purpose: To prospectively examine quality of life (QOL) of patients with early stage breast cancer treated with accelerated partial breast irradiation (APBI) using high-dose-rate (HDR) interstitial brachytherapy. Methods and Materials: Between March 2004 and December 2008, 151 patients with early stage breast cancer were enrolled in a phase 2 prospective clinical trial. Eligible patients included those with Tis-T2 tumors measuring ≤3 cm excised with negative surgical margins and with no nodal involvement. Patients received 3.4 Gy twice daily to a total dose of 34 Gy. QOL was measured using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, version 3.0, and QLQ-BR23 questionnaires. The QLQ-C30 and QLQ-BR23 questionnaires were evaluated during pretreatment and then at 6 to 8 weeks, 3 to 4 months, 6 to 8 months, and 1 and 2 years after treatment. Results: The median follow-up was 55 months. Breast symptom scores remained stable in the months after treatment, and they significantly improved 6 to 8 months after treatment. Scores for emotional functioning, social functioning, and future perspective showed significant improvement 2 years after treatment. Symptomatic fat necrosis was associated with several changes in QOL, including increased pain, breast symptoms, systemic treatment side effects, dyspnea, and fatigue, as well as decreased role functioning, emotional functioning, and social functioning. Conclusions: HDR multicatheter interstitial brachytherapy was well tolerated, with no significant detrimental effect on measured QOL scales/items through 2 years of follow-up. Compared to pretreatment scores, there was improvement in breast symptoms, emotional functioning, social functioning, and future perspective 2 years after treatment.

  18. A Prospective Longitudinal Clinical Trial Evaluating Quality of Life After Breast-Conserving Surgery and High-Dose-Rate Interstitial Brachytherapy for Early-Stage Breast Cancer

    International Nuclear Information System (INIS)

    Garsa, Adam A.; Ferraro, Daniel J.; DeWees, Todd A.; Deshields, Teresa L.; Margenthaler, Julie A.; Cyr, Amy E.; Naughton, Michael; Aft, Rebecca; Gillanders, William E.; Eberlein, Timothy; Matesa, Melissa A.; Ochoa, Laura L.; Zoberi, Imran

    2013-01-01

    Purpose: To prospectively examine quality of life (QOL) of patients with early stage breast cancer treated with accelerated partial breast irradiation (APBI) using high-dose-rate (HDR) interstitial brachytherapy. Methods and Materials: Between March 2004 and December 2008, 151 patients with early stage breast cancer were enrolled in a phase 2 prospective clinical trial. Eligible patients included those with Tis-T2 tumors measuring ≤3 cm excised with negative surgical margins and with no nodal involvement. Patients received 3.4 Gy twice daily to a total dose of 34 Gy. QOL was measured using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, version 3.0, and QLQ-BR23 questionnaires. The QLQ-C30 and QLQ-BR23 questionnaires were evaluated during pretreatment and then at 6 to 8 weeks, 3 to 4 months, 6 to 8 months, and 1 and 2 years after treatment. Results: The median follow-up was 55 months. Breast symptom scores remained stable in the months after treatment, and they significantly improved 6 to 8 months after treatment. Scores for emotional functioning, social functioning, and future perspective showed significant improvement 2 years after treatment. Symptomatic fat necrosis was associated with several changes in QOL, including increased pain, breast symptoms, systemic treatment side effects, dyspnea, and fatigue, as well as decreased role functioning, emotional functioning, and social functioning. Conclusions: HDR multicatheter interstitial brachytherapy was well tolerated, with no significant detrimental effect on measured QOL scales/items through 2 years of follow-up. Compared to pretreatment scores, there was improvement in breast symptoms, emotional functioning, social functioning, and future perspective 2 years after treatment

  19. Effect of moderate- versus high-intensity exercise on vascular function, biomarkers and quality of life in heart transplant recipients: A randomized, crossover trial.

    Science.gov (United States)

    Dall, Christian H; Gustafsson, Finn; Christensen, Stefan B; Dela, Flemming; Langberg, Henning; Prescott, Eva

    2015-08-01

    Growing evidence in long-term treatment of heart transplant (HTx) recipients indicates effects of high-intensity interval training (HIIT) on several parameters, including oxygen uptake, vascular function and psychological distress. In this study we compare the effect of HIIT vs continued moderate training (CON) on vascular function, biomarkers and health-related quality of life (HRQoL) in HTx recipients. A randomized, controlled crossover trial of stable HTx recipients >12 months after transplantation was done on patients with 12 weeks of HIIT or 12 weeks of CON, followed by a 5-month washout and crossover. Outcomes included endothelial function, arterial stiffness, biomarkers, HRQoL and markers of anxiety and depression. Sixteen HTx recipients (mean age 52 years, 75% male) completed the study. HIIT increased VO(2peak) more than CON (between-group difference, p HIIT patients (p = 0.02) and borderline increased in CON patients (p = 0.07), whereas there was no significant effect of exercise on the mental component. Depression score decreased significantly in HIIT patients (p = 0.04) with no change in CON patients (p = 0.75), whereas anxiety score decreased significantly in both HIIT (p 0.05). Arterial stiffness and biomarkers were not changed, nor did endothelial function change after HIIT (p = 0.08) or CON (p = 0.68). HIIT and CON are both well tolerated and induce similar improvements in physical components of HRQoL and in markers of anxiety. Effects of either training modality on vascular function and biomarkers could not be confirmed. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

  20. Randomized trials and quality assurance in gastric cancer surgery.

    Science.gov (United States)

    Dikken, Johan L; Cats, Annemieke; Verheij, Marcel; van de Velde, Cornelis J H

    2013-03-01

    A D2 lymphadenectomy can be considered standard of surgical care for advanced resectable gastric cancer. Currently, several multimodality strategies are used, including postoperative monochemotherapy in Asia, postoperative chemoradiotherapy in the United States, and perioperative chemotherapy in Europe. As the majority of gastric cancer patients are treated outside the framework of clinical trials, quality assurance programs, including referral to high-volume centers and clinical auditing are needed to improve gastric cancer care on a nationwide level. Copyright © 2012 Wiley Periodicals, Inc.

  1. [Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

    Science.gov (United States)

    Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

    2018-02-01

    To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials (1.09%) reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials

  2. The relationship between image quality and trial slits CT-1010

    International Nuclear Information System (INIS)

    Yoshinaga, Toshihiko; Nakamura, Sumio; Kakoi, Iwao; Ohkubo, Mitsuo; Tomiyoshi, Tsukasa

    1980-01-01

    We had used trial slits for EMI scanner CT-1010 and CT images of good quality almost free artifacts could be obtained when the slice thickness decreased to 5 mm. In this study, we experimented changes of MTF (modulation transfer function) as the slice thickness changed. As a result, MTF got worse as the slice thickness decreased, but got better as the exposure dose increased. The high accuracy high definitions of a 10 mm slice thickness and a 5 mm one were nearly equal in MTF. (author)

  3. Highly Efficient Training, Refinement, and Validation of a Knowledge-based Planning Quality-Control System for Radiation Therapy Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Li, Nan; Carmona, Ruben [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Sirak, Igor; Kasaova, Linda [Department of Oncology and Radiotherapy, University Hospital, Hradec Kralove (Czech Republic); Followill, David [Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Michalski, Jeff; Bosch, Walter; Straube, William [Department of Radiation Oncology, Washington University in St Louis, St Louis, Missouri (United States); Mell, Loren K. [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Moore, Kevin L., E-mail: kevinmoore@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States)

    2017-01-01

    Purpose: To demonstrate an efficient method for training and validation of a knowledge-based planning (KBP) system as a radiation therapy clinical trial plan quality-control system. Methods and Materials: We analyzed 86 patients with stage IB through IVA cervical cancer treated with intensity modulated radiation therapy at 2 institutions according to the standards of the INTERTECC (International Evaluation of Radiotherapy Technology Effectiveness in Cervical Cancer, National Clinical Trials Network identifier: 01554397) protocol. The protocol used a planning target volume and 2 primary organs at risk: pelvic bone marrow (PBM) and bowel. Secondary organs at risk were rectum and bladder. Initial unfiltered dose-volume histogram (DVH) estimation models were trained using all 86 plans. Refined training sets were created by removing sub-optimal plans from the unfiltered sample, and DVH estimation models… and DVH estimation models were constructed by identifying 30 of 86 plans emphasizing PBM sparing (comparing protocol-specified dosimetric cutpoints V{sub 10} (percentage volume of PBM receiving at least 10 Gy dose) and V{sub 20} (percentage volume of PBM receiving at least 20 Gy dose) with unfiltered predictions) and another 30 of 86 plans emphasizing bowel sparing (comparing V{sub 40} (absolute volume of bowel receiving at least 40 Gy dose) and V{sub 45} (absolute volume of bowel receiving at least 45 Gy dose), 9 in common with the PBM set). To obtain deliverable KBP plans, refined models must inform patient-specific optimization objectives and/or priorities (an auto-planning “routine”). Four candidate routines emphasizing different tradeoffs were composed, and a script was developed to automatically re-plan multiple patients with each routine. After selection of the routine that best met protocol objectives in the 51-patient training sample (KBP{sub FINAL}), protocol-specific DVH metrics and normal tissue complication probability were compared for original

  4. Effect of High-Intensity Interval Versus Continuous Exercise Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease: A RANDOMIZED CLINICAL TRIAL.

    Science.gov (United States)

    Jaureguizar, Koldobika Villelabeitia; Vicente-Campos, Davinia; Bautista, Lorena Ruiz; de la Peña, Cesar Hernández; Gómez, María José Arriaza; Rueda, María José Calero; Fernández Mahillo, Ignacio

    2016-01-01

    There is strong evidence that exercise training has beneficial health effects in patients with cardiovascular disease. Most studies have focused on moderate continuous training (MCT); however, a body of evidence has begun to emerge demonstrating that high-intensity interval training (HIIT) has significantly better results in terms of morbidity and mortality. The aim of this study was to compare the effects of MCT versus HIIT on functional capacity and quality of life and to assess safety. Seventy-two patients with ischemic heart disease were assigned to either HIIT or MCT for 8 weeks. We analyzed cardiopulmonary exercise test data, quality of life, and adverse events. High-intensity interval training resulted in a significantly greater increase in (Equation is included in full-text article.)O2peak (4.5 ± 4.7 mL·kg·min) compared with MCT (2.5 ± 3.6 mL·kg·min) (P HIIT and 14% in MCT. Furthermore, there was a significant (P HIIT group (49.6 ± 6.3 m) when compared with the MCT group (29.6 ± 12.0 m). Both training protocols improved quality of life. No adverse events were reported in either of the groups. On the basis of the results of this study, HIIT should be considered for use in cardiac rehabilitation as it resulted in a greater increase in functional capacity compared with MCT. We also observed greater improvement in quality of life without any increase in cardiovascular risk.

  5. High-dose rate iridium-192 brachytherapy with flexible applicator. A trial toward decrease of stress during treatment and improvement of quality of life

    International Nuclear Information System (INIS)

    Inoue, Keiji; Kasahara, Kotaro; Karashima, Takashi; Inoue, Yuichiro; Kariya, Shinji; Inomata, Taisuke; Yoshida, Shoji; Shuin, Taro

    2001-01-01

    We tried to improve the materials and methods of high-dose rate Iridium-192 brachytherapy for localized prostate cancer and evaluated the stress during the treatment in 20 patients with whom the therapy was performed. Rigid applicators made of stainless steel of 1.6 mm in diameter were indwelt with a template as usual for 30 hours in 14 patients (group A). Flexible applicators made of polyoxymethylene rosin (POM) of 2.0 mm in diameter were indwelt without a template for 30 hours after the applicator insertion in 6 patients (group B). We made inquiries about lumbago, inconvenience and necessity of assistant help and sleep in the course of therapy, and urinary incontinence and erectile function after the course of therapy as the QOL. The stress during the course of therapy in the patients of group B was obviously less than that of group A. There were no significant differences in urinary incontinence and erectile function after the course of therapy between group A and B. In this study, our trial successfully reduced the stress during the course of therapy in the patients with localized prostate cancer in the course of high-dose rate Iridium-192 brachytherapy. (author)

  6. High-dose rate iridium-192 brachytherapy with flexible applicator. A trial toward decrease of stress during treatment and improvement of quality of life

    Energy Technology Data Exchange (ETDEWEB)

    Inoue, Keiji; Kasahara, Kotaro; Karashima, Takashi; Inoue, Yuichiro; Kariya, Shinji; Inomata, Taisuke; Yoshida, Shoji; Shuin, Taro [Kochi Medical School, Nankoku (Japan)

    2001-07-01

    We tried to improve the materials and methods of high-dose rate Iridium-192 brachytherapy for localized prostate cancer and evaluated the stress during the treatment in 20 patients with whom the therapy was performed. Rigid applicators made of stainless steel of 1.6 mm in diameter were indwelt with a template as usual for 30 hours in 14 patients (group A). Flexible applicators made of polyoxymethylene rosin (POM) of 2.0 mm in diameter were indwelt without a template for 30 hours after the applicator insertion in 6 patients (group B). We made inquiries about lumbago, inconvenience and necessity of assistant help and sleep in the course of therapy, and urinary incontinence and erectile function after the course of therapy as the QOL. The stress during the course of therapy in the patients of group B was obviously less than that of group A. There were no significant differences in urinary incontinence and erectile function after the course of therapy between group A and B. In this study, our trial successfully reduced the stress during the course of therapy in the patients with localized prostate cancer in the course of high-dose rate Iridium-192 brachytherapy. (author)

  7. Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

    International Nuclear Information System (INIS)

    Gaze, Mark N.; Boterberg, Tom; Dieckmann, Karin; Hörmann, Marcus; Gains, Jennifer E.; Sullivan, Kevin P.; Ladenstein, Ruth

    2013-01-01

    Purpose: Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. Methods and Materials: The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. Results: It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Conclusions: Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

  8. Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

    Energy Technology Data Exchange (ETDEWEB)

    Gaze, Mark N., E-mail: mark.gaze@uclh.nhs.uk [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Boterberg, Tom [Department of Radiation Oncology, Ghent University Hospital, Ghent (Belgium); Dieckmann, Karin; Hoermann, Marcus [General Hospital Vienna, Medical University Vienna (Austria); Gains, Jennifer E.; Sullivan, Kevin P. [Department of Oncology, University College London Hospitals NHS Foundation Trust, London (United Kingdom); Ladenstein, Ruth [Children' s Cancer Research Institute, St. Anna Children' s Hospital, Vienna (Austria)

    2013-01-01

    Purpose: Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. Methods and Materials: The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. Results: It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Conclusions: Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

  9. Effects of different doses of high-speed resistance training on physical performance and quality of life in older women: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ramirez-Campillo R

    2016-12-01

    Objective: This study aimed to compare the effects of two frequencies of high-speed resistance training (HSRT on physical performance and quality of life of older women.Methods: A total of 24 older women participated in a 12-week HSRT program composed of either two or three sessions/week (equated for volume and intensity. Women were randomized into three arms: a control group (CG, n=8, a resistance training group performing two sessions/week (RT2, n=8, and a resistance training group performing three sessions/week (RT3, n=8. The training program for both experimental groups included exercises that required high-speed concentric muscle actions.Results: No baseline differences were observed among groups. Compared with the CG, both training groups showed similar small to moderate improvements (P<0.05 in muscle strength, power, functional performance, balance, and quality of life.Conclusion: These results suggest that equated for volume and intensity, two and three training sessions/week of HSRT are equally effective for improving physical performance and quality of life of older women. Keywords: aging, muscle strength, adaptation, frailty

  10. Effect of high-dose simvastatin on cognitive, neuropsychiatric, and health-related quality-of-life measures in secondary progressive multiple sclerosis: secondary analyses from the MS-STAT randomised, placebo-controlled trial.

    Science.gov (United States)

    Chan, Dennis; Binks, Sophie; Nicholas, Jennifer M; Frost, Chris; Cardoso, M Jorge; Ourselin, Sebastien; Wilkie, David; Nicholas, Richard; Chataway, Jeremy

    2017-08-01

    In the 24-month MS-STAT phase 2 trial, we showed that high-dose simvastatin significantly reduced the annualised rate of whole brain atrophy in patients with secondary progressive multiple sclerosis (SPMS). We now describe the results of the MS-STAT cognitive substudy, in which we investigated the treatment effect on cognitive, neuropsychiatric, and health-related quality-of-life (HRQoL) outcome measures. We did a secondary analysis of MS-STAT, a 24-month, double-blind, controlled trial of patients with SPMS done at three neuroscience centres in the UK between Jan 28, 2008, and Nov 4, 2011. Patients were randomly assigned (1:1) to either 80 mg simvastatin (n=70) or placebo (n=70). The cognitive assessments done were the National Adult Reading Test, Wechsler Abbreviated Scale of Intelligence, Graded Naming Test, Birt Memory and Information Processing Battery (BMIPB), Visual Object and Space Perception battery (cube analysis), Frontal Assessment Battery (FAB), and Paced Auditory Serial Addition Test. Neuropsychiatric status was assessed using the Hamilton Depression Rating Scale and the Neuropsychiatric Inventory Questionnaire. HRQoL was assessed using the self-reported 36-Item Short Form Survey (SF-36) version 2. Assessments were done at study entry, 12 months, and 24 months. Patients, treating physicians, and outcome assessors were masked to treatment allocation. Analyses were by intention to treat. MS-STAT is registered with ClinicalTrials.gov, number NCT00647348. Baseline assessment revealed impairments in 60 (45%) of 133 patients on the test of frontal lobe function (FAB), and in between 13 (10%) and 43 (33%) of 130 patients in tests of non-verbal and verbal memory (BMIPB). Over the entire trial, we noted significant worsening on tests of verbal memory (T score decline of 5·7 points, 95% CI 3·6-7·8; pmultiple sclerosis treatment trials. The Moulton Foundation, the Berkeley Foundation, the Multiple Sclerosis Trials Collaboration, the Rosetrees Trust, a

  11. Quality assurance trials for Ki67 assessment in pathology.

    Science.gov (United States)

    Raap, M; Ließem, S; Rüschoff, J; Fisseler-Eckhoff, A; Reiner, A; Dirnhofer, S; von Wasielewski, R; Kreipe, H

    2017-10-01

    Ki67 is a broadly used proliferation marker in surgical pathology with an obvious need for standardization to improve reproducibility of assessment. Here, we present results of the so far only existing round robin tests on Ki67, organized annually in Germany, Austria, and Switzerland from 2010 to 2015 with up to 160 participating laboratories (QuIP). In each quality assessment trial, eight probes from each breast cancer, neuroendocrine tumor, and malignant lymphoma were compiled on a tissue microarray (TMA). TMAs were stained in the participants' laboratories with antibodies and procedures also applied in their daily routine. Participating pathologists were expected to assign Ki67 values to one of four different categories for each tumor type. All local stainings and evaluations were reassessed by the organizing panel and compared to a preset standard. On average, 95% of participants reached the benchmark of over 80% concordance rates with the Ki67 category pre-established by the panel. Automatization and type of antibody did not affect the success rate. Concordance rates differed between tumor entities being highest in each tumor type with either very high or very low labeling indices. Lower rates were seen for intermediate Ki67 levels. Staining quality improved during the observation period as did inter-observer concordance with 85% of participants achieving excellent agreement (kappa > 0.8) in the first year and over 95% in 2015. In conclusion, regular external quality assurance trials have been established as a tool to improve the reproducibility and reliability of the prognostic and predictive proliferation marker Ki67.

  12. Quality assurance in clinical trials : a multi-disciplinary approach

    International Nuclear Information System (INIS)

    Cornes, D.

    2001-01-01

    Full text: Multi-disciplinary groups, such as medical physicists and radiation therapists, which work effectively together, can ensure continued improvements in radiation therapy quality. The same is also true for clinical trials, which have the added complication of requiring multi-institutional participation to collate sufficient data to effectively assess treatment benefits. It can be difficult to manage quality across all aspects of a multi-disciplinary and multi-institutional trial. A planned system of quality assurance is necessary to provide support for participating centres and facilitate a collaborative approach. To ensure protocol compliance a good relationship between the clinical trial group and treatment centre is idea with definition of mutual goals and objectives before and during the trial, and ongoing consultation and feedback throughout the trial process. To ensure good quality data and maximise the validity of results the study protocol must be strictly adhered to. Because of the need for meticulous attention to detail, both in treatment delivery and standards of documentation, clinical trials are often seen to further complicate the process of delivery of radiation therapy treatment. The Declaration of Helsinki and Good Clinical Practise Guidelines (adopted in May 1996, ICH) provide 'international ethical and scientific standards for designing, conducting, recording and reporting clinical research' and multi-disciplinary groups in each participating centre should also adhere to these guidelines. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

  13. Processes for Quality Improvements in Radiation Oncology Clinical Trials

    International Nuclear Information System (INIS)

    FitzGerald, T.J.; Urie, Marcia; Ulin, Kenneth; Laurie, Fran; Yorty, Jeffrey C.; Hanusik, Richard; Kessel, Sandy; Jodoin, Maryann Bishop; Osagie, Gani; Cicchetti, M. Giulia; Pieters, Richard; McCarten, Kathleen; Rosen, Nancy

    2008-01-01

    Quality assurance in radiotherapy (RT) has been an integral aspect of cooperative group clinical trials since 1970. In early clinical trials, data acquisition was nonuniform and inconsistent and computational models for radiation dose calculation varied significantly. Process improvements developed for data acquisition, credentialing, and data management have provided the necessary infrastructure for uniform data. With continued improvement in the technology and delivery of RT, evaluation processes for target definition, RT planning, and execution undergo constant review. As we move to multimodality image-based definitions of target volumes for protocols, future clinical trials will require near real-time image analysis and feedback to field investigators. The ability of quality assurance centers to meet these real-time challenges with robust electronic interaction platforms for imaging acquisition, review, archiving, and quantitative review of volumetric RT plans will be the primary challenge for future successful clinical trials

  14. Future vision for the quality assurance of oncology clinical trials

    Directory of Open Access Journals (Sweden)

    Thomas eFitzGerald, MD

    2013-03-01

    Full Text Available The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.

  15. Fast High-Quality Noise

    DEFF Research Database (Denmark)

    Frisvad, Jeppe Revall; Wyvill, Geoff

    2007-01-01

    At the moment the noise functions available in a graphics programmer's toolbox are either slow to compute or they involve grid-line artifacts making them of lower quality. In this paper we present a real-time noise computation with no grid-line artifacts or other regularity problems. In other words......, we put a new tool in the box that computes fast high-quality noise. In addition to being free of artifacts, the noise we present does not rely on tabulated data (everything is computed on the fly) and it is easy to adjust quality vs. quantity for the noise. The noise is based on point rendering (like...... spot noise), but it extends to more than two dimensions. The fact that it is based on point rendering makes art direction of the noise much easier....

  16. Use of a Real-Time Training Software (Laerdal QCPR®) Compared to Instructor-Based Feedback for High-Quality Chest Compressions Acquisition in Secondary School Students: A Randomized Trial.

    Science.gov (United States)

    Cortegiani, Andrea; Russotto, Vincenzo; Montalto, Francesca; Iozzo, Pasquale; Meschis, Roberta; Pugliesi, Marinella; Mariano, Dario; Benenati, Vincenzo; Raineri, Santi Maurizio; Gregoretti, Cesare; Giarratano, Antonino

    2017-01-01

    High-quality chest compressions are pivotal to improve survival from cardiac arrest. Basic life support training of school students is an international priority. The aim of this trial was to assess the effectiveness of a real-time training software (Laerdal QCPR®) compared to a standard instructor-based feedback for chest compressions acquisition in secondary school students. After an interactive frontal lesson about basic life support and high quality chest compressions, 144 students were randomized to two types of chest compressions training: 1) using Laerdal QCPR® (QCPR group- 72 students) for real-time feedback during chest compressions with the guide of an instructor who considered software data for students' correction 2) based on standard instructor-based feedback (SF group- 72 students). Both groups had a minimum of a 2-minute chest compressions training session. Students were required to reach a minimum technical skill level before the evaluation. We evaluated all students at 7 days from the training with a 2-minute chest compressions session. The primary outcome was the compression score, which is an overall measure of chest compressions quality calculated by the software expressed as percentage. 125 students were present at the evaluation session (60 from QCPR group and 65 from SF group). Students in QCPR group had a significantly higher compression score (median 90%, IQR 81.9-96.0) compared to SF group (median 67%, IQR 27.7-87.5), p = 0.0003. Students in QCPR group performed significantly higher percentage of fully released chest compressions (71% [IQR 24.5-99.0] vs 24% [IQR 2.5-88.2]; p = 0.005) and better chest compression rate (117.5/min [IQR 106-123.5] vs 125/min [115-135.2]; p = 0.001). In secondary school students, a training for chest compressions based on a real-time feedback software (Laerdal QCPR®) guided by an instructor is superior to instructor-based feedback training in terms of chest compression technical skill acquisition. Australian

  17. Systematic review: quality of trials on the symptomatic effects of the low FODMAP diet for irritable bowel syndrome

    DEFF Research Database (Denmark)

    Krogsgaard, L. R.; Lyngesen, M.; Bytzer, P.

    2017-01-01

    Background The low Fermentable Oligo-, Di- Monosaccharides, and Polyoles (FODMAP) diet is a new treatment option for irritable bowel syndrome (IBS). Experts refer to the diet as supported by high level of evidence, but an evaluation of the quality of trials is lacking. Aim To provide a systematic...... review of the quality of trials on the symptomatic effects of the low FODMAP diet for IBS. Methods Pubmed and EMBASE were searched for randomised controlled trials (RCTs) reporting effect of the low FODMAP diet on IBS symptoms. The quality of trials was evaluated by estimating risk of bias and assessing...... was instruction by a dietician and a variety of control interventions were used, all with limited established efficacy. Domains with a high risk of bias were identified for all the trials. High risk of bias dominated domains regarding blinding, with only one trial double-blinded. Conclusions The RCTs on the low...

  18. Training a Chest Compression of 6-7 cm Depth for High Quality Cardiopulmonary Resuscitation in Hospital Setting: A Randomised Controlled Trial.

    Science.gov (United States)

    Oh, Jaehoon; Lim, Tae Ho; Cho, Youngsuk; Kang, Hyunggoo; Kim, Wonhee; Chee, Youngjoon; Song, Yeongtak; Kim, In Young; Lee, Juncheol

    2016-03-01

    During cardiopulmonary resuscitation (CPR), chest compression (CC) depth is influenced by the surface on which the patient is placed. We hypothesized that training healthcare providers to perform a CC depth of 6-7 cm (instead of 5-6 cm) on a manikin placed on a mattress during CPR in the hospital might improve their proper CC depth. This prospective randomised controlled study involved 66 premedical students without CPR training. The control group was trained to use a CC depth of 5-6 cm (G 5-6), while the experimental group was taught to use a CC depth of 6-7 cm (G 6-7) with a manikin on the floor. All participants performed CCs for 2 min on a manikin that was placed on a bed 1 hour and then again 4 weeks after the training without a feedback. The parameters of CC quality (depth, rate, % of accurate depth) were assessed and compared between the 2 groups. Four students were excluded due to loss to follow-up and recording errors, and data of 62 were analysed. CC depth and % of accurate depth were significantly higher among students in the G 6-7 than G 5-6 both 1 hour and 4 weeks after the training (p0.05). Training healthcare providers to perform a CC depth of 6-7 cm could improve quality CC depth when performing CCs on patients who are placed on a mattress during CPR in a hospital setting.

  19. Assessing the effect of high-repetitive single limb exercises (HRSLE on exercise capacity and quality of life in patients with chronic obstructive pulmonary disease (COPD: study protocol for randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nyberg Andre

    2012-07-01

    Full Text Available Abstract Background Single-limb knee extension exercises have been found to be effective at improving lower extremity exercise capacity in patients with chronic obstructive pulmonary disease (COPD. Since the positive local physiological effects of exercise training only occur in the engaged muscle(s, should upper extremity muscles also be included to determine the effect of single limb exercises in COPD patients. Methods/design Trial design: a prospective, assessor-blind, block randomized controlled, parallel-group multicenter trial. Participants: stage II-IV COPD patients, > 40 years of age, ex-smokers, with stable medical treatment will be included starting May 2011. Recruitment at three locations in Sweden. Interventions: 1 high-repetitive single limb exercise (HRSLE training with elastic bands, 60 minutes, three times/week for 8 weeks combined with four sessions of 60 minutes patient education, or 2 the same patient education alone. Outcomes: Primary: determine the effects of HRSLE on local muscle endurance capacity (measured as meters walked during 6-minute walk test and rings moved on 6-minute ring and pegboard test and quality of life (measured as change on the Swedish version of the Chronic Respiratory Disease Questionnaire. Secondary: effects on maximal strength, muscular endurance, dyspnea, self-efficacy, anxiety and depression. The relationship between changes in health-related variables and changes in exercise capacity, sex-related differences in training effects, feasibility of the program, strategies to determine adequate starting resistance and provide accurate resistance for each involved movement and the relationship between muscle fatigue and dyspnea in the different exercise tests will also be analyzed. Randomization: performed by a person independent of the recruitment process and using a computer random number generator. Stratification by center and gender with a 1:1 allocation to the intervention or control using random

  20. A prospective clinical, economic, and quality-of-life analysis comparing endovascular aneurysm repair (EVAR), open repair, and best medical treatment in high-risk patients with abdominal aortic aneurysms suitable for EVAR: the Irish patient trial.

    LENUS (Irish Health Repository)

    Hynes, Niamh

    2007-12-01

    To report the results of a trial comparing endovascular aneurysm repair (EVAR) to open repair (OR) and best medical therapy (BMT) involving high-risk patients with abdominal aortic aneurysms (AAA) suitable for EVAR.

  1. A quality assessment of randomized controlled trial reports in endodontics.

    Science.gov (United States)

    Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

    2017-03-01

    To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  2. Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lee, Anne W.M. [Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Shenzhen (China); Vermorken, Jan B. [Department of Medical Oncology, Antwerp University Hospital, Edegem (Belgium); Wee, Joseph [Department of Radiation Oncology, National Cancer Centre Singapore (Singapore); O' Sullivan, Brian [Department of Radiation Oncology, University of Toronto, Ontario Cancer Institute, University Health Network, Toronto, Ontario (Canada); Eisbruch, Avraham [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Lin, Jin-Ching [Department of Radiation Oncology, Taichung Veterans General Hospital, Taichung, Taiwan (China); Mai, Hai-Qiang [Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Zhang, Li [Department of Medical Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Guo, Ying [Clinical Trials Centre, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lin, Ai-Hua [Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou (China); Sun, Ying [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); and others

    2017-05-01

    Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

  3. Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

    International Nuclear Information System (INIS)

    Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei; Lee, Anne W.M.; Vermorken, Jan B.; Wee, Joseph; O'Sullivan, Brian; Eisbruch, Avraham; Lin, Jin-Ching; Mai, Hai-Qiang; Zhang, Li; Guo, Ying; Lin, Ai-Hua; Sun, Ying

    2017-01-01

    Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

  4. Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

    Science.gov (United States)

    Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

    2017-01-01

    Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

  5. Process evaluation of the data-driven quality improvement in primary care (DQIP) trial: active and less active ingredients of a multi-component complex intervention to reduce high-risk primary care prescribing.

    Science.gov (United States)

    Grant, Aileen; Dreischulte, Tobias; Guthrie, Bruce

    2017-01-07

    Two to 4% of emergency hospital admissions are caused by preventable adverse drug events. The estimated costs of such avoidable admissions in England were £530 million in 2015. The data-driven quality improvement in primary care (DQIP) intervention was designed to prompt review of patients vulnerable from currently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) and anti-platelets and was found to be effective at reducing this prescribing. A process evaluation was conducted parallel to the trial, and this paper reports the analysis which aimed to explore response to the intervention delivered to clusters in relation to participants' perceptions about which intervention elements were active in changing their practice. Data generation was by in-depth interview with key staff exploring participant's perceptions of the intervention components. Analysis was iterative using the framework technique and drawing on normalisation process theory. All the primary components of the intervention were perceived as active, but at different stages of implementation: financial incentives primarily supported recruitment; education motivated the GPs to initiate implementation; the informatics tool facilitated sustained implementation. Participants perceived the primary components as interdependent. Intervention subcomponents also varied in whether and when they were active. For example, run charts providing feedback of change in prescribing over time were ignored in the informatics tool, but were motivating in some practices in the regular e-mailed newsletter. The high-risk NSAID and anti-platelet prescribing targeted was accepted as important by all interviewees, and this shared understanding was a key wider context underlying intervention effectiveness. This was a novel use of process evaluation data which examined whether and how the individual intervention components were effective from the perspective of the professionals delivering changed care to patients. These

  6. Quality assurance of the SCOPE 1 trial in oesophageal radiotherapy.

    Science.gov (United States)

    Wills, Lucy; Maggs, Rhydian; Lewis, Geraint; Jones, Gareth; Nixon, Lisette; Staffurth, John; Crosby, Tom

    2017-11-15

    SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres. A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins. 36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm 3 ; and PTV volumes 221.9-513.3 cm 3 . For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark

  7. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  8. Quantity and quality assessment of randomized controlled trials on orthodontic practice in PubMed.

    Science.gov (United States)

    Shimada, Tatsuo; Takayama, Hisako; Nakamura, Yoshiki

    2010-07-01

    To find current high-quality evidence for orthodontic practice within a reasonable time, we tested the performance of a PubMed search. PubMed was searched using publication type randomized controlled trial and medical subject heading term "orthodontics" for articles published between 2003 and 2007. The PubMed search results were compared with those from a hand search of four orthodontic journals to determine the sensitivity of PubMed search. We evaluated the precision of the PubMed search result and assessed the quality of individual randomized controlled trials using the Jadad scale. Sensitivity and precision were 97.46% and 58.12%, respectively. In PubMed, of the 277 articles retrieved, 161 (58.12%) were randomized controlled trials on orthodontic practice, and 115 of the 161 articles (71.42%) were published in four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics. Assessment by the Jadad scale revealed 60 high-quality randomized controlled trials on orthodontic practice, of which 45 (75%) were published in these four journals. PubMed is a highly desirable search engine for evidence-based orthodontic practice. To stay current and get high-quality evidence, it is reasonable to look through four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics.

  9. COLLABORATIVE TRIAL AND QUALITY CONTROL IN CHEMICAL ANALYSIS

    Directory of Open Access Journals (Sweden)

    Narsito Narsito

    2010-06-01

    Full Text Available Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of analytical method, quality assurance in chemical analysis. The assessment of quality parameter for analytical method like the use of standard materials as well as standard methods is given. Concerning with the quality control of analytical data, the use of several techniques, such as control samples and control charts, in monitoring analytical data in quality control program are described qualitatively.  In the final part of this paper, some important remarks for the preparation of collaborative trials, including the evaluation of accuracy and reproducibility of analytical method are also given Keywords: collaborative trials, quality control, analytical data Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of

  10. Quality of methodological reporting of randomized clinical trials of sodium-glucose cotransporter-2 (sglt2 inhibitors

    Directory of Open Access Journals (Sweden)

    Hadeel Alfahmi

    2017-01-01

    Full Text Available Sodium-glucose cotransporter-2 (SGLT2 inhibitors are a new class of medicines approved recently for the treatment of type 2 diabetes. To improve the quality of randomized clinical trial (RCT reports, the Consolidated Standards of Reporting Trials (CONSORT statement for methodological features was created. For achieving our objective in this study, we assessed the quality of methodological reporting of RCTs of SGLT2 inhibitors according to the 2010 CONSORT statement. We reviewed and analyzed the methodology of SGLT2 inhibitors RCTs that were approved by the Food & Drug Administration (FDA. Of the 27 trials, participants, eligibility criteria, and additional analyses were reported in 100% of the trials. In addition, trial design, interventions, and statistical methods were reported in 96.3% of the trials. Outcomes were reported in 93.6% of the trials. Settings were reported in 85.2% of the trials. Blinding and sample size were reported in 66.7 and 59.3% of the trials, respectively. Sequence allocation and the type of randomization were reported in 63 and 74.1% of the trials, respectively. Besides those, a few methodological items were inadequate in the trials. Allocation concealment was inadequate in most of the trials. It was reported only in 11.1% of the trials. The majority of RCTs have high percentage adherence for more than half of the methodological items of the 2010 CONSORT statement.

  11. Quality control of radiation therapy in clinical trials

    International Nuclear Information System (INIS)

    Kramer, S.; Lustig, R.; Grundy, G.

    1983-01-01

    The RTOG is a group of participating institutions which has a major interest in furthering clinical radiation oncology. They have formulated protocols for clinical investigation in which radiation therapy is the major modality of treatment. In addition, other modalities, such as chemotherapy, radiation sensitizers, and hyperthermia, are used in combined approach to cancer. Quality control in all aspects of patient management is necessary to insure quality data. These areas include evaluation of pathology, physics, and dosimetry, and clinical patient data. Quality control is both time consuming and expensive. However, by dividing these tasks into various levels and time frames, by using computerized data-control mechanisms, and by employing appropriate levels of ancillary personnel expertise, quality control can improve compliance and decrease the cost of investigational trials

  12. Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

    Science.gov (United States)

    Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

    2011-06-01

    To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

  13. The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial.

    Science.gov (United States)

    Marx, Wolfgang; McCarthy, Alexandra L; Ried, Karin; McKavanagh, Dan; Vitetta, Luis; Sali, Avni; Lohning, Anna; Isenring, Elisabeth

    2017-08-12

    Ginger supplementation could be an effective adjuvant treatment for chemotherapy-induced nausea (CIN). The aim of this clinical trial was to address significant methodological limitations in previous trials. Patients (N = 51) were randomly allocated to receive either 1.2 g of standardised ginger extract or placebo per day, in addition to standard anti-emetic therapy, during the first three cycles of chemotherapy. The primary outcome was CIN-related quality of life (QoL) measured with the Functional Living Index- Emesis (FLIE) questionnaire. Secondary outcomes included acute and delayed nausea, vomiting, and retching as well as cancer-related fatigue, nutritional status, and CIN and vomiting-specific prognostic factors. Over three consecutive chemotherapy cycles, nausea was more prevalent than vomiting (47% vs. 12%). In chemotherapy Cycle 1, intervention participants reported significantly better QoL related to CIN ( p = 0.029), chemotherapy-induced nausea and vomiting (CINV)-related QoL ( p = 0.043), global QoL ( p = 0.015) and less fatigue ( p = 0.006) than placebo participants. There were no significant results in Cycle 2. In Cycle 3, global QoL ( p = 0.040) and fatigue ( p = 0.013) were significantly better in the intervention group compared to placebo. This trial suggests adjuvant ginger supplementation is associated with better chemotherapy-induced nausea-related quality of life and less cancer-related fatigue, with no difference in adverse effects compared to placebo.

  14. Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3) : an open-label, multicentre, randomised, phase 3 trial

    NARCIS (Netherlands)

    de Boer, Stephanie M.; Powell, Melanie E.; Mileshkin, Linda; Katsaros, Dionyssios; Bessette, Paul; Haie-Meder, Christine; Ottevanger, Petronella B.; Ledermann, Jonathan A.; Khaw, Pearly; Colombo, Alessandro; Fyles, Anthony; Baron, Marie-Helene; Kitchener, Henry C.; Nijman, Hans W.; Kruitwagen, Roy F.; Nout, Remi A.; Verhoeven-Adema, Karen W.; Smit, Vincent T.; Putter, Hein; Creutzberg, Carien L.

    Background About 15% of patients with endometrial cancer have high-risk features and are at increased risk of distant metastases and endometrial cancer-related death. We designed the PORTEC-3 trial to investigate the benefit of adjuvant chemoradiotherapy compared with radiotherapy alone for women

  15. Toxicity and quality of life after adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): an open-label, multicentre, randomised, phase 3 trial

    NARCIS (Netherlands)

    Boer, S.M. de; Powell, M.E.; Mileshkin, L.; Katsaros, D.; Bessette, P.; Haie-Meder, C.; Ottevanger, P.B.; Ledermann, J.A.; Khaw, P.; Colombo, A.; Fyles, A.; Baron, M.H.; Kitchener, H.C.; Nijman, H.W.; Kruitwagen, R.F.; Nout, R.A.; Verhoeven-Adema, K.W.; Smit, V.T.; Putter, H.; Creutzberg, C.L.

    2016-01-01

    BACKGROUND: About 15% of patients with endometrial cancer have high-risk features and are at increased risk of distant metastases and endometrial cancer-related death. We designed the PORTEC-3 trial to investigate the benefit of adjuvant chemoradiotherapy compared with radiotherapy alone for women

  16. Short- and Long-Term Quality of Life and Bowel Function in Patients With MRI-Defined, High-Risk, Locally Advanced Rectal Cancer Treated With an Intensified Neoadjuvant Strategy in the Randomized Phase 2 EXPERT-C Trial

    International Nuclear Information System (INIS)

    Sclafani, Francesco; Peckitt, Clare; Cunningham, David; Tait, Diana; Giralt, Jordi; Glimelius, Bengt; Keränen, Susana Roselló; Bateman, Andrew; Hickish, Tamas; Tabernero, Josep; Thomas, Janet; Brown, Gina; Oates, Jacqueline; Chau, Ian

    2015-01-01

    Objective: Intensified preoperative treatments have been increasingly investigated in locally advanced rectal cancer (LARC), but limited data are available for the impact of these regimens on quality of life (QoL) and bowel function (BF). We assessed these outcome measures in EXPERT-C, a randomized phase 2 trial of neoadjuvant capecitabine combined with oxaliplatin (CAPOX), followed by chemoradiation therapy (CRT), total mesorectal excision, and adjuvant CAPOX with or without cetuximab in magnetic resonance imaging-defined, high-risk LARC. Methods and Materials: QoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR29 questionnaires. Bowel incontinence was assessed using the modified Fecal Incontinence Severity Index questionnaire. Results: Compared to baseline, QoL scores during preoperative treatment were better for symptoms associated with the primary tumor in the rectum (blood and mucus in stool, constipation, diarrhea, stool frequency, buttock pain) but worse for global health status, role functioning, and symptoms related to the specific safety profile of each treatment modality. During follow-up, improved emotional functioning and lessened anxiety and insomnia were observed, but deterioration of body image, increased urinary incontinence, less sexual interest (men), and increased impotence and dyspareunia were observed. Cetuximab was associated with a deterioration of global health status during neoadjuvant chemotherapy but did not have any long-term detrimental effect. An improvement in bowel continence was observed after preoperative treatment and 3 years after sphincter-sparing surgery. Conclusions: Intensifying neoadjuvant treatment by administering induction systemic chemotherapy before chemoradiation therapy improves tumor-related symptoms and does not appear to have a significantly detrimental effect on QoL and BF, in both the short and the long term

  17. Short- and Long-Term Quality of Life and Bowel Function in Patients With MRI-Defined, High-Risk, Locally Advanced Rectal Cancer Treated With an Intensified Neoadjuvant Strategy in the Randomized Phase 2 EXPERT-C Trial

    Energy Technology Data Exchange (ETDEWEB)

    Sclafani, Francesco; Peckitt, Clare [The Royal Marsden NHS Foundation Trust, London (United Kingdom); Cunningham, David, E-mail: david.cunningham@rmh.nhs.uk [The Royal Marsden NHS Foundation Trust, London (United Kingdom); Tait, Diana [The Royal Marsden NHS Foundation Trust, London (United Kingdom); Giralt, Jordi [Vall d' Hebron University Hospital, Universitat Autònoma de Barcelona, Department of Medical Oncology, Barcelona (Spain); Glimelius, Bengt [University of Uppsala, Uppsala (Sweden); Keränen, Susana Roselló [Biomedical Research Institute INCLIVA, Department of Hematology and Medical Oncology, University of Valencia (Spain); Bateman, Andrew [Southampton General Hospital, Cancer Sciences Unit, University of Southampton (United Kingdom); Hickish, Tamas [Poole Hospital NHS Foundation Trust, Department of Medical Oncology, Bournemouth University (United Kingdom); Tabernero, Josep [Vall d' Hebron University Hospital, Universitat Autònoma de Barcelona, Department of Medical Oncology, Barcelona (Spain); Thomas, Janet; Brown, Gina; Oates, Jacqueline; Chau, Ian [The Royal Marsden NHS Foundation Trust, London (United Kingdom)

    2015-10-01

    Objective: Intensified preoperative treatments have been increasingly investigated in locally advanced rectal cancer (LARC), but limited data are available for the impact of these regimens on quality of life (QoL) and bowel function (BF). We assessed these outcome measures in EXPERT-C, a randomized phase 2 trial of neoadjuvant capecitabine combined with oxaliplatin (CAPOX), followed by chemoradiation therapy (CRT), total mesorectal excision, and adjuvant CAPOX with or without cetuximab in magnetic resonance imaging-defined, high-risk LARC. Methods and Materials: QoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR29 questionnaires. Bowel incontinence was assessed using the modified Fecal Incontinence Severity Index questionnaire. Results: Compared to baseline, QoL scores during preoperative treatment were better for symptoms associated with the primary tumor in the rectum (blood and mucus in stool, constipation, diarrhea, stool frequency, buttock pain) but worse for global health status, role functioning, and symptoms related to the specific safety profile of each treatment modality. During follow-up, improved emotional functioning and lessened anxiety and insomnia were observed, but deterioration of body image, increased urinary incontinence, less sexual interest (men), and increased impotence and dyspareunia were observed. Cetuximab was associated with a deterioration of global health status during neoadjuvant chemotherapy but did not have any long-term detrimental effect. An improvement in bowel continence was observed after preoperative treatment and 3 years after sphincter-sparing surgery. Conclusions: Intensifying neoadjuvant treatment by administering induction systemic chemotherapy before chemoradiation therapy improves tumor-related symptoms and does not appear to have a significantly detrimental effect on QoL and BF, in both the short and the long term.

  18. A systematic review of the quality of homeopathic clinical trials

    Science.gov (United States)

    Jonas, Wayne B; Anderson, Rachel L; Crawford, Cindy C; Lyons, John S

    2001-01-01

    Background While a number of reviews of homeopathic clinical trials have been done, all have used methods dependent on allopathic diagnostic classifications foreign to homeopathic practice. In addition, no review has used established and validated quality criteria allowing direct comparison of the allopathic and homeopathic literature. Methods In a systematic review, we compared the quality of clinical-trial research in homeopathy to a sample of research on conventional therapies using a validated and system-neutral approach. All clinical trials on homeopathic treatments with parallel treatment groups published between 1945–1995 in English were selected. All were evaluated with an established set of 33 validity criteria previously validated on a broad range of health interventions across differing medical systems. Criteria covered statistical conclusion, internal, construct and external validity. Reliability of criteria application is greater than 0.95. Results 59 studies met the inclusion criteria. Of these, 79% were from peer-reviewed journals, 29% used a placebo control, 51% used random assignment, and 86% failed to consider potentially confounding variables. The main validity problems were in measurement where 96% did not report the proportion of subjects screened, and 64% did not report attrition rate. 17% of subjects dropped out in studies where this was reported. There was practically no replication of or overlap in the conditions studied and most studies were relatively small and done at a single-site. Compared to research on conventional therapies the overall quality of studies in homeopathy was worse and only slightly improved in more recent years. Conclusions Clinical homeopathic research is clearly in its infancy with most studies using poor sampling and measurement techniques, few subjects, single sites and no replication. Many of these problems are correctable even within a "holistic" paradigm given sufficient research expertise, support and methods

  19. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    DEFF Research Database (Denmark)

    Bello, Segun; Wei, Maoling; Hilden, Jørgen

    2016-01-01

    to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods: Systematic review. We searched Pub...... published before 1977. The studies differed considerably with regard to design, methodology and analysis. Sixteen of the 36 studies (44 %) concluded inadequate matching. When we adapted high or low thresholds for inadequate matching, the number of trials with inadequate matching was reduced to 12 (33...

  20. Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

    Directory of Open Access Journals (Sweden)

    Humam Saltaji

    Full Text Available To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time.We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics.Sequence generation was assessed to be inadequate (at unclear or high risk of bias in 68% (n = 367 of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%. Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154 and 40.5% (n = 219 of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427 of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95 of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%, while the method of blinding was appropriate in 53% (n = 286 of the trials. We identified a significant decrease over time (1955-2013 in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05 in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias.The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent

  1. The relation between quality of clinical trials and acupuncture efficacy

    Directory of Open Access Journals (Sweden)

    David Gonçalves Nordon

    2013-06-01

    Full Text Available Introduction: Clinical trials of acupuncture not always have concordant results, mostly due to their great heterogeneity. Two indexes have been developed to analyze the quality of acupuncture trials. This study hypothesizes that, the more adequate the intervention and the control techniques, the more efficacious the acupuncture. Methods: Both indexes were applied to 27 randomized clinical trials comparing acupuncture to placebo. Results were compared by using the Mann-Whitney test. Results: Studies favorable to acupuncture had a intervention score’s median of 11.5; for the unfavorable ones, it was 7, p: 0.0017. Articles with and without statistically significant differences, though, had the same median for their scores in the control index: 6. Discussion: There is a positive relation between a better score for acupuncture technique and a statistically significant difference between acupuncture and interventional control. However, due to the little heterogeneity in the degree of physiological effect from each article, the control index had no statistical significance. Conclusion: This study established that, among acupuncture RCT controlled by placebo or sham of moderate physiological effect, the adequacy of the technique is more important than the adequacy of control in establishing a statistically significant difference between acupuncture and interventional control.

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

    Science.gov (United States)

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

    2013-07-01

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

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

    International Nuclear Information System (INIS)

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

    2013-01-01

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

  4. Endorsement of the CONSORT guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: A cross-sectional analysis.

    Science.gov (United States)

    Jull, Andrew; Aye, Phyu Sin

    2015-06-01

    To establish the reporting quality of trials published in leading nursing journals and investigate associations between CONSORT Statement or trial registration endorsment and reporting of design elements. The top 15 nursing journals were searched using Medline for randomised controlled trials published in 2012. Journals were categorised as CONSORT and trial registration promoting based on requirements of submitting authors or the journal's webpage as at January 2014. Data on sequence generation, allocation concealment, follow up, blinding, baseline equivalence and sample size calculation were extracted by one author and independently verified by the second author against source data. Seven journals were CONSORT promoting and three of these journals were also trial registration promoting. 114 citations were identified and 83 were randomised controlled trials. Eighteen trials (21.7%) were registered and those published in trial registration promoting journals were more likely to be registered (RR 2.64 95%CI 1.14-6.09). We assessed 68.7% of trials to be low risk of bias for sequence generation, 20.5% for allocation concealment, 38.6% for blinding, 55.4% for completeness of follow up and 79.5% for baseline equivalence. Trials published in CONSORT promoting journals were more likely to be at low risk of bias for blinding (RR 2.33, 95%CI 1.01-5.34) and completeness of follow up (RR 1.77, 95%CI 1.02-3.10), but journal endorsement of the CONSORT Statement or trial registration otherwise had no significant effect. Trials published in CONSORT and trial registration promoting journals were more likely to have high quality sample size calculations (RR 2.91, 95%CI 1.18-7.19 and RR 1.69, 95%CI 1.08-2.64, respectively). Simple endorsement of the CONSORT Statement and trials registration is insufficient action to encourage improvement of the quality of trial reporting across the most important of trial design elements. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Availability of high quality weather data measurements

    DEFF Research Database (Denmark)

    Andersen, Elsa; Johansen, Jakob Berg; Furbo, Simon

    In the period 2016-2017 the project “Availability of high quality weather data measurements” is carried out at Department of Civil Engineering at the Technical University of Denmark. The aim of the project is to establish measured high quality weather data which will be easily available...... for the building energy branch and the solar energy branch in their efforts to achieve energy savings and for researchers and students carrying out projects where measured high quality weather data are needed....

  6. The reporting quality of randomized controlled trials in orthodontics.

    Science.gov (United States)

    Lempesi, Evangelia; Koletsi, Despina; Fleming, Padhraig S; Pandis, Nikolaos

    2014-06-01

    Accurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting. The 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling. 128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values. The reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions. Copyright

  7. Does mentoring new peer reviewers improve review quality? A randomized trial

    Directory of Open Access Journals (Sweden)

    Houry Debra

    2012-08-01

    Full Text Available Abstract Background Prior efforts to train medical journal peer reviewers have not improved subsequent review quality, although such interventions were general and brief. We hypothesized that a manuscript-specific and more extended intervention pairing new reviewers with high-quality senior reviewers as mentors would improve subsequent review quality. Methods Over a four-year period we randomly assigned all new reviewers for Annals of Emergency Medicine to receive our standard written informational materials alone, or these materials plus a new mentoring intervention. For this program we paired new reviewers with a high-quality senior reviewer for each of their first three manuscript reviews, and asked mentees to discuss their review with their mentor by email or phone. We then compared the quality of subsequent reviews between the control and intervention groups, using linear mixed effects models of the slopes of review quality scores over time. Results We studied 490 manuscript reviews, with similar baseline characteristics between the 24 mentees who completed the trial and the 22 control reviewers. Mean quality scores for the first 3 reviews on our 1 to 5 point scale were similar between control and mentee groups (3.4 versus 3.5, as were slopes of change of review scores (-0.229 versus -0.549 and all other secondary measures of reviewer performance. Conclusions A structured training intervention of pairing newly recruited medical journal peer reviewers with senior reviewer mentors did not improve the quality of their subsequent reviews.

  8. Zerodur polishing process for high surface quality and high efficiency

    International Nuclear Information System (INIS)

    Tesar, A.; Fuchs, B.

    1992-08-01

    Zerodur is a glass-ceramic composite importance in applications where temperature instabilities influence optical and mechanical performance, such as in earthbound and spaceborne telescope mirror substrates. Polished Zerodur surfaces of high quality have been required for laser gyro mirrors. Polished surface quality of substrates affects performance of high reflection coatings. Thus, the interest in improving Zerodur polished surface quality has become more general. Beyond eliminating subsurface damage, high quality surfaces are produced by reducing the amount of hydrated material redeposited on the surface during polishing. With the proper control of polishing parameters, such surfaces exhibit roughnesses of < l Angstrom rms. Zerodur polishing was studied to recommend a high surface quality polishing process which could be easily adapted to standard planetary continuous polishing machines and spindles. This summary contains information on a polishing process developed at LLNL which reproducibly provides high quality polished Zerodur surfaces at very high polishing efficiencies

  9. Engineering high quality medical software

    CERN Document Server

    Coronato, Antonio

    2018-01-01

    This book focuses on high-confidence medical software in the growing field of e-health, telecare services and health technology. It covers the development of methodologies and engineering tasks together with standards and regulations for medical software.

  10. Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs.

    Science.gov (United States)

    Hecht, Arthur; Busch-Heidger, Barbara; Gertzen, Heiner; Pfister, Heike; Ruhfus, Birgit; Sanden, Per-Holger; Schmidt, Gabriele B

    2015-01-01

    This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF. The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs.

  11. Quality expectations and tolerance limits of trial master files (TMF) – Developing a risk-based approach for quality assessments of TMFs

    Science.gov (United States)

    Hecht, Arthur; Busch-Heidger, Barbara; Gertzen, Heiner; Pfister, Heike; Ruhfus, Birgit; Sanden, Per-Holger; Schmidt, Gabriele B.

    2015-01-01

    This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF. The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs. PMID:26693218

  12. Quality expectations and tolerance limits of trial master files (TMF – Developing a risk-based approach for quality assessments of TMFs

    Directory of Open Access Journals (Sweden)

    Hecht, Arthur

    2015-12-01

    Full Text Available This article addresses the question of when a trial master file (TMF can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF.The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany and are QA (quality assurance experts (auditors or compliance functions with long-term experience in the practical handling of TMFs.

  13. The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST)

    DEFF Research Database (Denmark)

    Winther, Kristian Hillert; Watt, Torquil; Bjørner, Jakob Bue

    2014-01-01

    Patients with chronic autoimmune thyroiditis have impaired health-related quality of life. The thyroid gland has a high selenium concentration, and specific selenoprotein enzyme families are crucial to immune function, and catalyze thyroid hormone metabolism and redox processes in thyroid cells......-enriched yeast or matching placebo tablets daily for 12 months. The experimental supplement will be SelenoPrecise(R). The primary outcome is thyroid-related quality of life assessed by the Thyroid Patient-Reported Outcome (ThyPRO) questionnaire. Secondary outcomes include serum thyroid peroxidase antibody...

  14. 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.

    Science.gov (United States)

    Grant, Aileen; Dreischulte, Tobias; Guthrie, Bruce

    2017-03-10

    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. Mixed-methods parallel process evaluation of a cluster trial, reporting the comparative case study of purposively selected practices. Ten (30%) primary care practices participating in the trial from Scotland, UK. 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. 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 trial. Practices organised their delivery of

  15. Quality management manual for production of high quality cassava flour

    DEFF Research Database (Denmark)

    Dziedzoave, Nanam Tay; Abass, Adebayo Busura; Amoa-Awua, Wisdom K.

    The high quality cassava flour (HQCF) industry has just started to evolve in Africa and elsewhere. The sustainability of the growing industry, the profitability of small- and medium-scale enterprises (SMEs) that are active in the industry and good-health of consumers can best be guaranteed through...... the adoption of proper quality and food safety procedures. Cassava processing enterprises involved in the productionof HQCF must therefore be commited to the quality and food safety of the HQCF. They must have the right technology, appropriate processing machhinery, standard testing instruments...... and the necessary technical expertise. This quality manual was therefore developed to guide small- to medium-scale cassava in the design and implematation of Hazard Analysis Critical Control Point (HACCP) system and Good manufacturing Practices (GMP) plans for HQCF production. It describes the HQCF production...

  16. High quality-factor optical resonators

    International Nuclear Information System (INIS)

    Henriet, Rémi; Salzenstein, Patrice; Coillet, Aurélien; Saleh, Khaldoun; Chembo, Yanne K; Ristic, Davor; Ferrari, Maurizio; Mortier, Michel; Rasoloniaina, Alphonse; Dumeige, Yannick; Féron, Patrice; Cibiel, Gilles; Llopis, Olivier

    2014-01-01

    Various resonators are investigated for microwave photonic applications. Micro-sphere, disk and fiber ring resonators were designed, realized and characterized. Obtained quality factors are as high as Q = 10 10 . (paper)

  17. High-quality compressive ghost imaging

    Science.gov (United States)

    Huang, Heyan; Zhou, Cheng; Tian, Tian; Liu, Dongqi; Song, Lijun

    2018-04-01

    We propose a high-quality compressive ghost imaging method based on projected Landweber regularization and guided filter, which effectively reduce the undersampling noise and improve the resolution. In our scheme, the original object is reconstructed by decomposing of regularization and denoising steps instead of solving a minimization problem in compressive reconstruction process. The simulation and experimental results show that our method can obtain high ghost imaging quality in terms of PSNR and visual observation.

  18. Optimizing Radiation Therapy Quality Assurance in Clinical Trials: A TROG 08.03 RAVES Substudy

    Energy Technology Data Exchange (ETDEWEB)

    Trada, Yuvnik, E-mail: yuvnik@gmail.com [Calvary Mater Newcastle, Waratah, New South Wales (Australia); Kneebone, Andrew [Royal North Shore Hospital, St Lenoards, New South Wales (Australia); Paneghel, Andrea [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Pearse, Maria [Auckland Hospital, Auckland (New Zealand); Sidhom, Mark [Liverpool Hospital, Liverpool, New South Wales (Australia); Tang, Colin [Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); Wiltshire, Kirsty; Haworth, Annette [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Fraser-Browne, Carol [Auckland Hospital, Auckland (New Zealand); Martin, Jarad [Calvary Mater Newcastle, Waratah, New South Wales (Australia)

    2015-12-01

    Purpose: To explore site- and clinician-level factors associated with protocol violations requiring real-time-review (RTR) resubmission in a multicenter clinical trial to help tailor future quality assurance (QA) protocols. Methods and Materials: RAVES (Radiation Therapy–Adjuvant vs Early Salvage) (Trans-Tasman Radiation Oncology Group 08.03) is a randomized trial comparing adjuvant with early salvage radiation therapy in men with positive surgical margins or pT3 disease after prostatectomy. Quality assurance in RAVES required each clinician and site to submit a credentialing dummy run (DR) and for each patient's radiation therapy plan to undergo external RTR before treatment. Prospectively defined major violations from trial protocol required remedy and resubmission. Site and clinician factors associated with RTR resubmission were examined using hierarchical modeling. Results: Data were collected from 171 consecutive patients, treated by 46 clinicians at 32 hospitals. There were 47 RTR resubmissions (27%) due to 65 major violations. The relative rate of resubmission decreased by 29% per year as the study progressed (odds ratio OR. 0.71, P=.02). The majority of resubmissions were due to contouring violations (39 of 65) and dosimetric violations (22 of 65). For each additional patient accrued, significant decreases in RTR resubmission were seen at both clinician level (OR 0.75, P=.02) and site level (OR 0.72, P=.01). The rate of resubmission due to dosimetric violations was only 1.6% after the first 5 patients. Use of IMRT was associated with lower rates of resubmission compared with 3-dimensional conformal radiation therapy (OR 0.38, P=.05). Conclusion: Several low- and high-risk factors that may assist with tailoring future clinical trial QA were identified. Because the real-time resubmission rate was largely independent of the credentialing exercise, some form of RTR QA is recommended. The greatest benefit from QA was derived early in trial activation

  19. A systematic review of the quality of homeopathic pathogenetic trials published from 1945 to 1995.

    Science.gov (United States)

    Dantas, F; Fisher, P; Walach, H; Wieland, F; Rastogi, D P; Teixeira, H; Koster, D; Jansen, J P; Eizayaga, J; Alvarez, M E P; Marim, M; Belon, P; Weckx, L L M

    2007-01-01

    The quality of information gathered from homeopathic pathogenetic trials (HPTs), also known as 'provings', is fundamental to homeopathy. We systematically reviewed HPTs published in six languages (English, German, Spanish, French, Portuguese and Dutch) from 1945 to 1995, to assess their quality in terms of the validity of the information they provide. The literature was comprehensively searched, only published reports of HPTs were included. Information was extracted by two reviewers per trial using a form with 87 items. Information on: medicines, volunteers, ethical aspects, blinding, randomization, use of placebo, adverse effects, assessments, presentation of data and number of claimed findings were recorded. Methodological quality was assessed by an index including indicators of internal and external validity, personal judgement and comments of reviewers for each study. 156 HPTs on 143 medicines, involving 2815 volunteers, produced 20,538 pathogenetic effects (median 6.5 per volunteer). There was wide variation in methods and results. Sample size (median 15, range 1-103) and trial duration (mean 34 days) were very variable. Most studies had design flaws, particularly absence of proper randomization, blinding, placebo control and criteria for analysis of outcomes. Mean methodological score was 5.6 (range 4-16). More symptoms were reported from HPTs of poor quality than from better ones. In 56% of trials volunteers took placebo. Pathogenetic effects were claimed in 98% of publications. On average about 84% of volunteers receiving active treatment developed symptoms. The quality of reports was in general poor, and much important information was not available. The HPTs were generally of low methodological quality. There is a high incidence of pathogenetic effects in publications and volunteers but this could be attributable to design flaws. Homeopathic medicines, tested in HPTs, appear safe. The central question of whether homeopathic medicines in high dilutions can

  20. Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

    Science.gov (United States)

    Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

    2018-06-07

    Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

  1. Quality of randomized controlled trials published in the International Urogynecology Journal 2007-2016.

    Science.gov (United States)

    Kim, Kyu Shik; Chung, Jae Hoon; Jo, Jung Ki; Kim, Jae Heon; Kim, Seungjun; Cho, Jeoung Man; Cho, Hee Ju; Choi, Hong Yong; Lee, Seung Wook

    2018-07-01

    Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016. RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration's risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed. Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013 and 2016, particularly 2013 and 2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p < 0.01). Jadad scores and van Tulder rose significantly until 2014 (p < 0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and p < 0.01, respectively). Intervention description did not associate with better quality. RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment.

  2. [Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals].

    Science.gov (United States)

    Sun, Yan-nan; Lei, Fei-fei; Cao, Yan-li; Fu, Min-kui

    2010-02-01

    To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials (CONSORT) was assessed. Four hundred and ninety-four clinical trials were retrieved, and 21.3% (105/494) of them were supported by grants. For the study design, only 26.1% (129/494) were prospective studies, and 3.8% (19/494) were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intention to treat compromised the quality. The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.

  3. Fabrication of high-quality brazed joints

    International Nuclear Information System (INIS)

    Orlov, A.V.

    1980-01-01

    Problem of ensuring of joint high-quality when brazing different parts in power engineering is considered. To obtain high-quality joints it is necessary to correctly design brazed joint and to choose a gap width, overlap length and fillet radius; to clean up carefully the surfaces to be brazed and fix them properly one relative to another; to apply a solder so as to provide its flowing into the gap and sticking in it; to exactly regulate thermal conditions of brazing. High quality and reliability of brazed joints are ensured by the application of solders based on noble metals, and cheap solders based on nickel, manganese and copper. Joints brazed with nickel base solders may operate at temperatures as high as 888 deg C

  4. TOTAL QUALITY MANAGEMENT IN HIGH EDUCATION

    Directory of Open Access Journals (Sweden)

    Hasan SERİN, Alper AYTEKİN

    2009-01-01

    Full Text Available The approach of Total Quality Management (TQM has been even more common and most recently its use in high education has been discussed. Likewise the enterprises producing various products, universities have also inputs, processes, and outputs. Due to conditions of competition, universities have to improve the qualities of these inputs, processes, and outputs, according to satisfaction, demands, and expectations of internal and external customers. If the TQM has been implemented in the universities with a manner that aims for customer satisfaction (students, lecturers, public and private establishments, and families, supports constant development, ensures participatory approach, and encourages working in groups, it will provide universities with effectiveness, efficiency, dynamics, and economics. In this study, common problems of universities, definitions of quality and TQM in high education, customer concept at universities, and factors affecting the quality of education have been explained. Besides, in order TQM approach to be successfully implemented in the universities, various suggestions have been presented.

  5. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

    Science.gov (United States)

    Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R

    2017-09-07

    There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout

  6. No short-cut in assessing trial quality: a case study

    Directory of Open Access Journals (Sweden)

    Hirji Karim F

    2009-01-01

    Full Text Available Abstract Background Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment. Results The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991 is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations. Conclusion A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.

  7. Effect of forage quality in faeces from different ruminant species fed high and low quality forage

    DEFF Research Database (Denmark)

    Jalali, A R; Nørgaard, P; Nielsen, M O

    2010-01-01

    Effect of forage quality in faeces from different ruminant species fed high and low quality forage......Effect of forage quality in faeces from different ruminant species fed high and low quality forage...

  8. Assuring quality in high-consequence engineering

    Energy Technology Data Exchange (ETDEWEB)

    Hoover, Marcey L.; Kolb, Rachel R.

    2014-03-01

    In high-consequence engineering organizations, such as Sandia, quality assurance may be heavily dependent on staff competency. Competency-dependent quality assurance models are at risk when the environment changes, as it has with increasing attrition rates, budget and schedule cuts, and competing program priorities. Risks in Sandia's competency-dependent culture can be mitigated through changes to hiring, training, and customer engagement approaches to manage people, partners, and products. Sandia's technical quality engineering organization has been able to mitigate corporate-level risks by driving changes that benefit all departments, and in doing so has assured Sandia's commitment to excellence in high-consequence engineering and national service.

  9. Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.

    Science.gov (United States)

    Denburg, Avram; Rodriguez-Galindo, Carlos; Joffe, Steven

    2016-06-01

    Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a "trial effect," however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure-the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research-may function as a quality improvement lever, improving the quality of care and outcomes of all patients within an institution or region independent of their individual participation in trials. We further contend that this "infrastructure effect" can yield particular benefits for patients in low- and middle-income countries (LMICs). The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development.

  10. Producing high-quality slash pine seeds

    Science.gov (United States)

    James Barnett; Sue Varela

    2003-01-01

    Slash pine is a desirable species. It serves many purposes and is well adapted to poorly drained flatwoods and seasonally flooded areas along the lower Coastal Plain of the Southeastern US. The use of high-quality seeds has been shown to produce uniform seedlings for outplanting, which is key to silvicultural success along the Coastal Plain and elsewhere. We present...

  11. Endorectal high dose rate brachytherapy quality assurance

    International Nuclear Information System (INIS)

    Devic, S.; Vuong, T.; Evans, M.; Podgorsak, E.

    2008-01-01

    We describe our quality assurance method for preoperative high dose rate (HDR) brachytherapy of endorectal tumours. Reproduction of the treatment planning dose distribution on a daily basis is crucial for treatment success. Due to the cylindrical symmetry, two types of adjustments are necessary: applicator rotation and dose distribution shift along the applicator axis. (author)

  12. Effectiveness of the Spirometry 360 Quality Improvement Program for Improving Asthma Care: A Cluster Randomized Trial.

    Science.gov (United States)

    Mangione-Smith, Rita; Zhou, Chuan; Corwin, Michael J; Taylor, James A; Rice, Fiona; Stout, James W

    To determine the effectiveness of the Spirometry 360 distance learning quality improvement (QI) program for enhancing the processes and outcomes of care for children with asthma. Cluster randomized controlled trial involving 25 matched pairs of pediatric primary care practices. Practices were recruited from 2 practice-based research networks: the Slone Center Office-based Research Network at Boston University, Boston, Mass, and the Puget Sound Pediatric Research Network, Seattle, Wash. Study participants included providers from one of the 50 enrolled pediatric practices and 626 of their patients with asthma. Process measures assessed included spirometry test quality and appropriate prescription of asthma controller medications. Outcome measures included asthma-specific health-related quality of life, and outpatient, emergency department, and inpatient utilization for asthma. At baseline, 25.4% of spirometry tests performed in control practices and 50.4% of tests performed in intervention practices were of high quality. During the 6-month postintervention period, 28.7% of spirometry tests performed in control practices and 49.9% of tests performed in intervention practices were of high quality. The adjusted difference-of-differences analysis revealed no intervention effect on spirometry test quality. Adjusted differences-of-differences analysis also revealed no intervention effect on appropriate use of controller medications or any of the parent- or patient-reported outcomes examined. In this study, the Spirometry 360 distance learning QI program was ineffective in improving spirometry test quality or parent- or patient-reported outcomes. QI programs like the one assessed here may need to focus on practices with lower baseline performance levels or may need to be tailored for those with higher baseline performance. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  13. How product trial changes quality perception of four new processed beef products

    DEFF Research Database (Denmark)

    Saeed, Faiza; Grunert, Klaus G; Therkildsen, Margrethe

    2013-01-01

    evaluation, quality evaluation and purchase motive fulfillment. For two of the tested products, trial resulted in a decline of the evaluation of cues, quality and purchase motive fulfillment compared to pre-trial expectations. For these products, positive expectations were created by giving information about...... and gender, which may be due to underlying differences in previous experience. The study gives useful insights for testing of new processed meat products before market introduction....

  14. High Quality Virtual Reality for Architectural Exhibitions

    DEFF Research Database (Denmark)

    Kreutzberg, Anette

    2016-01-01

    This paper will summarise the findings from creating and implementing a visually high quality Virtual Reality (VR) experiment as part of an international architecture exhibition. It was the aim to represent the architectural spatial qualities as well as the atmosphere created from combining natural...... and artificial lighting in a prominent not yet built project. The outcome is twofold: Findings concerning the integration of VR in an exhibition space and findings concerning the experience of the virtual space itself. In the exhibition, an important aspect was the unmanned exhibition space, requiring the VR...... experience to be self-explanatory. Observations of different visitor reactions to the unmanned VR experience compared with visitor reactions at guided tours with personal instructions are evaluated. Data on perception of realism, spatial quality and light in the VR model were collected with qualitative...

  15. Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

    Science.gov (United States)

    Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

    2014-02-01

    Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

  16. Quality of diets with fluidized bed combustion residue treatment: I. Rat trials

    Energy Technology Data Exchange (ETDEWEB)

    Cahill, N.J.; Reid, R.L.; Head, M.K.; Hern, J.L.; Bennett, O.L.

    Feeding trials were conducted with rats (Rattus rattus) to examine effects of soil application, or dietary inclusion, of fluidized bed combustion residue (FBCR) on the composition and quality of foods. Four diets (vegetable protein, egg protein, chicken, chicken + dietary FBCR) prepared with either FBCR or lime (control) treatments, were fed to weanling, female rats in three growth and reproduction trials. Intake, growth rate, and composition of body and organs of rats were measured. Rats in one trial were bred, their litters maintained on dietary treatments, and the offspring rebred. Treatment (FBCR vs. lime) x diet interactions on food composition and animal responses generally were not significant. Treatment had little effect on element composition of diets; mineral concentrations were in normal ranges. Diet treatment with FBCR depressed (P<0.01) food intake and growth of rats in one trial, but not in others, and had no effect (P<0.05) on body water, protein, ether extract, or gross energy composition. Some differences in element concentrations in the carcass and organs of rats and pups resulted from FBCR treatment, but effects were small and inconsistent. Litters from the first reproductive cycle appeared normal, except for animals fed the chicken + dietary FBCR treatment, on which pups showed poor growth and anemia. Offspring from certain diets were rebred and litters showed a high mortality, although this was not associated specifically with FBCR treatment. Results indicated no major detrimental effects on food composition, or growth, tissue element accumulation, and reproduction in the rat relating to use of FBCR as a soil amendment. 20 refs., 9 tabs.

  17. High quality transportation fuels from renewable feedstock

    Energy Technology Data Exchange (ETDEWEB)

    Lindfors, Lars Peter

    2010-09-15

    Hydrotreating of vegetable oils is novel process for producing high quality renewable diesel. Hydrotreated vegetable oils (HVO) are paraffinic hydrocarbons. They are free of aromatics, have high cetane numbers and reduce emissions. HVO can be used as component or as such. HVO processes can also be modified to produce jet fuel. GHG savings by HVO use are significant compared to fossil fuels. HVO is already in commercial production. Neste Oil is producing its NExBTL diesel in two plants. Production of renewable fuels will be limited by availability of sustainable feedstock. Therefore R and D efforts are made to expand feedstock base further.

  18. Boiling curve in high quality flow boiling

    International Nuclear Information System (INIS)

    Shiralkar, B.S.; Hein, R.A.; Yadigaroglu, G.

    1980-01-01

    The post dry-out heat transfer regime of the flow boiling curve was investigated experimentally for high pressure water at high qualities. The test section was a short round tube located downstream of a hot patch created by a temperature controlled segment of tubing. Results from the experiment showed that the distance from the dryout point has a significant effect on the downstream temperatures and there was no unique boiling curve. The heat transfer coefficients measured sufficiently downstream of the dryout point could be correlated using the Heineman correlation for superheated steam, indicating that the droplet deposition effects could be neglected in this region

  19. Breeding and maintaining high-quality insects

    DEFF Research Database (Denmark)

    Jensen, Kim; Kristensen, Torsten Nygård; Heckmann, Lars-Henrik

    2017-01-01

    Insects have a large potential for sustainably enhancing global food and feed production, and commercial insect production is a rising industry of high economic value. Insects suitable for production typically have fast growth, short generation time, efficient nutrient utilization, high...... reproductive potential, and thrive at high density. Insects may cost-efficiently convert agricultural and industrial food by-products into valuable protein once the technology is finetuned. However, since insect mass production is a new industry, the technology needed to efficiently farm these animals is still...... in a starting phase. Here, we discuss the challenges and precautions that need to be considered when breeding and maintaining high-quality insect populations for food and feed. This involves techniques typically used in domestic animal breeding programs including maintaining genetically healthy populations...

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

    Science.gov (United States)

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

    2018-01-01

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

  1. Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board

    Directory of Open Access Journals (Sweden)

    Isabelle Gautier

    2017-08-01

    Full Text Available Abstract Background There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118 before and after the initiation of the EU Pediatric Regulation. Methods All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR Network and ranked using the Jadad score. Results Out of 622 protocols submitted to the Institutional Review Board (IRB, 21% (133/622 included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5, 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3. Conclusion Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.

  2. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial

    DEFF Research Database (Denmark)

    Coens, Corneel; Suciu, Stefan; Chiarion-Sileni, Vanna

    2017-01-01

    consisted mainly of skin, gastrointestinal, endocrine, and hepatic immune-related adverse events. Adjuvant treatment with ipilimumab in this setting was approved in October, 2014, by the US Food and Drug Administration based on the results of the primary outcome of this trial. Here, we report the results...... were randomly assigned (1:1) centrally by an interactive voice response system, to receive either ipilimumab 10 mg/kg or placebo every 3 weeks for four doses, then every 3 months for up to 3 years. Using a minimisation technique, randomisation was stratified by disease stage and geographical region...

  3. The BNCT facility at the HFR Petten: Quality assurance for reactor facilities in clinical trials

    International Nuclear Information System (INIS)

    Moss, R.; Watkins, P.; Vroegindeweij, C.; Stecher-Rasmussen, F.; Huiskamp, R.; Ravensberg, K.; Appelman, K.; Sauerwein, W.; Hideghety, K.; Gabel, D.

    2001-01-01

    The first clinical trial in Europe of Boron Neutron Capture Therapy (BNCT) for the treatment of glioblastoma was opened in July 1997. The trial is a Phase I study with the principal aim to establish the maximum tolerated radiation dose and the dose limiting toxicity under defined conditions. It is the first time that a clinical application could be realised on a completely multi-national scale. The treatment takes place at the High Flux Reactor (HFR) in Petten, the Netherlands, is operated by an international team of experts under the leadership of a German radiotherapist, and treats patients coming from different European countries. It has therefore been necessary to create a very specialised organisation and contractual structure with the support of administrations from different countries, who had to find and adapt solutions within existing laws that had never foreseen such a situation. Furthermore, the treatment does not take place in an hospital environment and even more so, the facility is at a nuclear research reactor. Hence, special efforts were made on quality assurance, in order that the set-up at the facility and the personnel involved complied, as closely as possible, with similar practices in conventional radiotherapy departments. (author)

  4. Quantitative Quality Assurance in a Multicenter HARDI Clinical Trial at 3T

    Science.gov (United States)

    Zhou, Xiaopeng; Sakaie, Ken E.; Debbins, Josef P.; Kirsch, John E.; Tatsuoka, Curtis; Fox, Robert J.; Lowe, Mark J.

    2016-01-01

    A phantom-based quality assurance (QA) protocol was developed for a multicenter clinical trial including high angular resolution diffusion imaging (HARDI). A total of 27 3T MR scanners from 2 major manufacturers, GE (Discovery and Signa scanners) and Siemens (Trio and Skyra scanners), were included in this trial. With this protocol, agar phantoms doped to mimic relaxation properties of brain tissue are scanned on a monthly basis, and quantitative procedures are used to detect spiking and to evaluate eddy current and Nyquist ghosting artifacts. In this study, simulations were used to determine alarm thresholds for minimal acceptable signal-to-noise ratio (SNR). Our results showed that spiking artifact was the most frequently observed type of artifact. Overall, Trio scanners exhibited less eddy current distortion than GE scanners, which in turn showed less distortion than Skyra scanners. This difference was mainly caused by the different sequences used on these scanners. The SNR for phantom scans was closely correlated with the SNR from volunteers. Nearly all of the phantom measurements with artifact-free images were above the alarm threshold, suggesting that the scanners are stable longitudinally. Software upgrades and hardware replacement sometimes affected SNR substantially but sometimes did not. In light of these results, it is important to monitor longitudinal SNR with phantom QA to help interpret potential effects on in vivo measurements. Our phantom QA procedure for HARDI scans was successful in tracking scanner performance and detecting unwanted artifacts. PMID:27587227

  5. A high yielding, better quality chickpea mutant variety 'NIFA-95'

    International Nuclear Information System (INIS)

    Hassan, S.; Javed, M.A.; Khattak, S.U.K.; Iqbal, M.M.

    2001-01-01

    Chickpea or gram (Cicer arietinum L.) is an important legume crop of Pakistan, grown on over one million hectares annually. The national average yield of the crop is very low (0.5 t/ha) and thus the country had to spent about 2 billion rupees ($ 50 million) on import of pulses. The main causes of low yield are non-availability of genetic sources for resistance to various diseases especially gram blight Ascochyta rabiei (Pass.) Lab., insect pest (Pod borer) and non-adoption of proper production technology by the farmers. This calls for earnest efforts of breeders to evolve high yielding and disease resistant varieties of chickpea for provision of quality seeds to the farming community to increase production of this important crop. Seeds of a highly blight susceptible variety '6153' were irradiated at 200 Gy dose of gamma radiation in 1985 and the promising mutant line CMN-446-4 was selected in M3 generation on the basis of disease resistance, greater number of pods and better plant type. After confirmation of its resistance to blight in M 4 and M 5 , the mutant line was evaluated in various trials at different locations. In the advanced and zonal yield trials during 1993-95, the line CMN-446-4 produced the highest grain yield of 2,600 kg/ha as compared to the rest of the mutants and varieties. The line was also evaluated in the chickpea national uniform yield trial, conducted on over 11 locations in the country during 1993-94. In this trial, the mutant line ranked 3rd by producing an average yield of 1,528 kg/ha as compared to the two check varieties 'Punjab-91' (1,316 kg/ha) and 'Paidar-91' (1,391 kg/ha). The mutant line CMN-446-4 is moderately resistant to gram blight, highly resistant to stored pest (pulse beetle), contains 25.3% more protein as compared to the parental variety 6153 and is also better in nitrogen fixing capacity.The proposal for release of the mutant line CMN-446-4 as a new variety under the name 'NIFA-95' for general cultivation in the rainfed

  6. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    Energy Technology Data Exchange (ETDEWEB)

    Fairchild, Alysa, E-mail: alysa.fairchild@albertahealthservices.ca [Department of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta (Canada); Straube, William [Advanced Technology Consortium, Imaged-Guided Therapy QA Center, St. Louis, Missouri (United States); Laurie, Fran [Quality Assurance Review Center, Lincoln, Rhode Island (United States); Followill, David [Radiological Physics Center, University of Texas MD Anderson Cancer Centre, Houston, Texas (United States)

    2013-10-01

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question.

  7. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    International Nuclear Information System (INIS)

    Fairchild, Alysa; Straube, William; Laurie, Fran; Followill, David

    2013-01-01

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question

  8. Improved quality monitoring of multi-center acupuncture clinical trials in China

    Directory of Open Access Journals (Sweden)

    Zheng Hui

    2009-12-01

    Full Text Available Abstract Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs. Methods A standard quality control program (QCP was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.

  9. Funding source and the quality of reports of chronic wounds trials: 2004 to 2011.

    Science.gov (United States)

    Hodgson, Robert; Allen, Richard; Broderick, Ellen; Bland, J Martin; Dumville, Jo C; Ashby, Rebecca; Bell-Syer, Sally; Foxlee, Ruth; Hall, Jill; Lamb, Karen; Madden, Mary; O'Meara, Susan; Stubbs, Nikki; Cullum, Nicky

    2014-01-14

    Critical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of chronic wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality. A systematic search for RCTs for the treatment of chronic wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out.Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed. A total of 167 RCTs met our inclusion criteria. We found chronic wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered. This overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must

  10. Method for synthesis of high quality graphene

    Science.gov (United States)

    Lanzara, Alessandra [Piedmont, CA; Schmid, Andreas K [Berkeley, CA; Yu, Xiaozhu [Berkeley, CA; Hwang, Choonkyu [Albany, CA; Kohl, Annemarie [Beneditkbeuern, DE; Jozwiak, Chris M [Oakland, CA

    2012-03-27

    A method is described herein for the providing of high quality graphene layers on silicon carbide wafers in a thermal process. With two wafers facing each other in close proximity, in a first vacuum heating stage, while maintained at a vacuum of around 10.sup.-6 Torr, the wafer temperature is raised to about 1500.degree. C., whereby silicon evaporates from the wafer leaving a carbon rich surface, the evaporated silicon trapped in the gap between the wafers, such that the higher vapor pressure of silicon above each of the wafers suppresses further silicon evaporation. As the temperature of the wafers is raised to about 1530.degree. C. or more, the carbon atoms self assemble themselves into graphene.

  11. High quality data: An evaluation of AIM data quality and data quality procedures

    Science.gov (United States)

    The goal of every monitoring program is to collect high-quality data which can then be used to provide information to decision makers. The Bureau of Land Management (BLM) Assessment, Inventory, and Monitoring (AIM) program is one such data set which provides rangeland status, condition, and trend in...

  12. High-picture quality industrial CT scanner

    International Nuclear Information System (INIS)

    Shoji, Takao; Nishide, Akihiko; Fujii, Masashi.

    1989-01-01

    Industrial X-ray-CT-scanners, which provide cross-sectional images of a tested sample without destroying it, are attracting attention as a new nondestructive inspection device. In 1982, Toshiba commenced the development of industrial CT scanners, and introduced the 'TOSCANER' -3000 and-4000 series. Now, the state of the art 'TOSCANER'-20000 series of CT systems has been developed incorporating the latest computer tomography and image processing technology, such as the T9506 image processor. One of the advantages of this system is its applicability to a wide range of X-ray energy . The 'TOSCANER'-20000 series can be utilized for inspecting castings and other materials with relatively low-transparency to X-rays, as well as ceramics, composite materials and other materials with high X-ray transparency. A further feature of the new system is its high-picture quality, with a high-spatial resolution resulting from a pixel size of 0.2x0.2(mm). (author)

  13. [Quality management is associated with high quality services in health care].

    Science.gov (United States)

    Nielsen, Tenna Hassert; Riis, Allan; Mainz, Jan; Jensen, Anne-Louise Degn

    2013-12-09

    In these years, quality management has been the focus in order to meet high quality services for the patients in Danish health care. This article provides information on quality management and quality improvement and it evaluates its effectiveness in achieving better organizational structures, processes and results in Danish health-care organizations. Our findings generally support that quality management is associated with high quality services in health care.

  14. Optical studies of high quality synthetic diamond

    International Nuclear Information System (INIS)

    Sharp, S.J.

    1999-01-01

    This thesis is concerned with the study of fundamental and defect induced optical properties of synthetic diamond grown using high pressure, high temperature (HPHT) synthesis or chemical vapour deposition (CVD). The primary technique used for investigation is cathodoluminescence (including imaging and decay-time measurements) in addition to other forms of optical spectroscopy. This thesis is timely in that the crystallinity and purity of synthetic diamond has increased ten fold over the last few years. The diamond exciton emission, which is easily quenched by the presence of defects, is studied in high quality samples in detail. In addition the ability now exists to engineer the isotopic content of synthetic diamond to a high degree of accuracy. The experimental chapters are divided as follows: Chapter 2: High resolution, low temperature spectra reveal a splitting of the free-exciton phonon recombination emission peaks and the bound-exciton zero phonon line. Included are measurements of the variation in intensity and decay-time as a function of temperature. Chapter 3: The shift in energy of the phonon-assisted free-exciton phonon replicas with isotopic content has been measured. The shift is in agreement with the results of interatomic force model for phonon scattering due to isotope disorder. Chapter 4: A study of the shift in energy with isotopic content of the diamond of the GR1 band due to the neutral vacancy has allowed a verification of the theoretical predictions due to the Jahn Teller effect. Chapter 5: The spatial distribution of the free-exciton luminescence is studied in HPHT synthetic and CVD diamond. A variation in intensity with distance from the surface is interpreted as a significant non-radiative loss of excitons to the surface. Chapter 6: The decay-times of all known self-interstitial related centres have been measured in order to calculate the concentration of these centres present in electron irradiated diamond. (author)

  15. High Quality Data for Grid Integration Studies

    Energy Technology Data Exchange (ETDEWEB)

    Clifton, Andrew; Draxl, Caroline; Sengupta, Manajit; Hodge, Bri-Mathias

    2017-01-22

    As variable renewable power penetration levels increase in power systems worldwide, renewable integration studies are crucial to ensure continued economic and reliable operation of the power grid. The existing electric grid infrastructure in the US in particular poses significant limitations on wind power expansion. In this presentation we will shed light on requirements for grid integration studies as far as wind and solar energy are concerned. Because wind and solar plants are strongly impacted by weather, high-resolution and high-quality weather data are required to drive power system simulations. Future data sets will have to push limits of numerical weather prediction to yield these high-resolution data sets, and wind data will have to be time-synchronized with solar data. Current wind and solar integration data sets are presented. The Wind Integration National Dataset (WIND) Toolkit is the largest and most complete grid integration data set publicly available to date. A meteorological data set, wind power production time series, and simulated forecasts created using the Weather Research and Forecasting Model run on a 2-km grid over the continental United States at a 5-min resolution is now publicly available for more than 126,000 land-based and offshore wind power production sites. The National Solar Radiation Database (NSRDB) is a similar high temporal- and spatial resolution database of 18 years of solar resource data for North America and India. The need for high-resolution weather data pushes modeling towards finer scales and closer synchronization. We also present how we anticipate such datasets developing in the future, their benefits, and the challenges with using and disseminating such large amounts of data.

  16. Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, K Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R; Keenan, Jeremy D

    2015-06-01

    Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. Secondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3). Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52). We found evidence of improvement in vision-related quality of life among patients with fungal ulcers

  17. A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

    Science.gov (United States)

    Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

    2018-05-15

    To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

  18. Quality assurance in head and neck surgical oncology : EORTC 24954 trial on larynx preservation

    NARCIS (Netherlands)

    Leemans, C. R.; Tijink, B. M.; Langendijk, J. A.; Andry, G.; Hamoir, M.; Lefebvre, J. L.

    Background: The Head and Neck Cancer Group (HNCG) of the EORTC conducted a quality assurance program in the EORTC 24954 trial on larynx preservation. In this multicentre study, patients with resectable advanced squamous cell carcinoma of the larynx or hypopharynx were randomly assigned for treatment

  19. Criteria for designing an MRI quality assurance program. A multicenter trial

    International Nuclear Information System (INIS)

    Mascaro, L.; Baldassarri, A.M.

    1999-01-01

    The authors report the preliminary results of a multicenter trial aimed at defining methods, reference values and frequency of measurements for a magnetic resonance quality assurance program. In particular, they stress the definition of two attention levels (investigation and intervention) for image uniformity and signal-to-noise ratio (SNR) by means short-and long-term measurements [it

  20. Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

    Directory of Open Access Journals (Sweden)

    Jing-Yi Li

    2011-01-01

    Full Text Available Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs in the Tai Chi literature following the publication of the CONSORT guidelines in 2001. Data Sources. The OVID MEDLINE and PUBMED databases. Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i it was an original report of the trial; (ii its design was RCT; (iii one of the treatments being tested was Tai Chi; and (iv it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews. Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials. Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

  1. Effect of a natural extract of chicken combs with a high content of hyaluronic acid (Hyal-Joint® on pain relief and quality of life in subjects with knee osteoarthritis: a pilot randomized double-blind placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Schwartz Howard

    2008-01-01

    Full Text Available Abstract Background Intra-articular hyaluronic acid represents a substantive addition to the therapeutic armamentarium in knee osteoarthritis. We examined the effect of dietary supplementation with a natural extract of chicken combs with a high content of hyaluronic acid (60% (Hyal-Joint® (active test product, AP on pain and quality of life in subjects with osteoarthritis of the knee. Methods Twenty subjects aged ≥40 years with knee osteoarthritis (pain for at least 15 days in the previous month, symptoms present for ≥6 months, Kellgren/Lawrence score ≥2 participated in a randomized double-blind controlled trial. Ten subjects received AP (80 mg/day and 10 placebo for 8 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC and quality of life by the Short Form-36 (SF-36v2 were administered at baseline and after 4 and 8 weeks of treatment. Results WOMAC pain (primary efficacy variable was similar in both study groups (mean [SD] with 6.6 (4.0 points in the AP group and 6.4 (2.7 in the placebo group (P = 0.943. As compared with baseline, subjects in both groups showed statistically significant improvements in WOMAC pain, stiffness, physical function subscales, and in the aggregate score, but the magnitude of changes was higher in the AP group for WOMAC physical function (-13.1 [12.0] vs. -10.1 [8.6], P = 0.575 and total symptoms (-18.6 [16.8] vs. -15.8 [11.4], P = 0.694. At 4 weeks, statistically significant mean changes compared with baseline were observed in the SF-36v2 scales of role-physical, bodily pain, social functioning and role-emotional among subjects in the AP group, and in physical functioning, bodily pain, and social functioning in the placebo group. At 8 weeks, changes were significant for role-physical, bodily pain, and physical component summary in the AP group, and for physical functioning and role-emotional in the placebo arm. Changes in bodily pain and social functioning were of greater magnitude

  2. The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Gluud, Christian; Wetterslev, Jørn

    2005-01-01

    To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation.......To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation....

  3. Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists.

    Science.gov (United States)

    Kyte, Derek; Ives, Jonathan; Draper, Heather; Keeley, Thomas; Calvert, Melanie

    2013-01-01

    Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting

  4. Ensuring High-Quality Learning for All

    Science.gov (United States)

    Núñez, Elsa M.

    2018-01-01

    The Association of American Colleges and Universities (AAC&U) has embarked on a sustained program to enhance the quality of student learning on campuses, while also supporting AAC&U members' efforts to bring liberal education to all sectors of society. This commitment to quality and equity in service to democracy forms the basis for…

  5. Quality of reporting of randomized controlled trials of pharmacologic treatment of bipolar disorders: a systematic review.

    Science.gov (United States)

    Strech, Daniel; Soltmann, Bettina; Weikert, Beate; Bauer, Michael; Pfennig, Andrea

    2011-09-01

    This study aimed to assess (1) the quality of reporting of randomized controlled trials of pharmacologic treatment of bipolar disorder, (2) the potential improvement in quality of reporting over time, and (3) differences in quality of reporting between journals that endorse or do not endorse the Uniform Requirements for Manuscripts Submitted to Biomedical Journals developed by the International Committee of Medical Journal Editors. A systematic literature search was done to identify all randomized controlled trials published between 2000 and 2008 relevant to the pharmacologic treatment of bipolar disorder. The search strategy of the published National Institute for Health and Clinical Excellence guideline for management of bipolar disorders was used and adapted. All included and excluded clinical trials mentioned in the guideline and published from 2000 onward were reviewed for eligibility. For an update search from July 2004 through December 2008, an adapted search strategy was used in MEDLINE, EMBASE, PsycINFO, CINAHL, Ovid, and Cochrane Central Register of Controlled Trials. Titles and abstracts were scanned for relevance, and full texts were ordered in case of uncertainty to maximize sensitivity. Reference lists of retrieved systematic reviews were checked. All full texts were checked for eligibility. Only relevant randomized controlled trials published between 2000 and 2008 were included. Abstracts, randomized controlled trials published before 2000, nonrandomized clinical studies, pooled analyses, editorials, reviews, case reports, observational studies, and unpublished reports were excluded. A checklist based on the Consolidated Standards of Reporting Trials (CONSORT) statement was used to assess quality of reporting of all included studies. A total of 105 randomized controlled trials were included in the analysis. Of the 72 applicable checklist items, 42% were generally reported adequately and 25% inadequately. Reporting was especially poor for

  6. Implementation of External Quality Assurance Trials for Immunohistochemically Determined Breast Cancer Biomarkers in Germany.

    Science.gov (United States)

    von Wasielewski, Reinhard; Krusche, Claudia A; Rüschoff, Joseph; Fisseler-Eckhoff, Anette; Kreipe, Hans

    2008-01-01

    Besides typing and grading of breast cancer, Pathologists are involved in the determination of biomarkers, such as steroid hormone receptors and HER2, which are of utmost importance in adjuvant therapy. There have been concerns with regard to security and reproducibility of the biomarker assays done on tissue sections applying either immunohistochemistry or in-situ hybridisation. In order to assure the quality of these biomarker assays, a number of measures are required, among them external proficiency testing. Therefore, external quality assurance trials have been implemented in Germany. In the period of 2002-2007, 5 consecutive trials were conducted with up to 180 participating laboratories. Tissue microarrays with 20-24 different breast cancer samples including cell lines enabled that a huge number of pathologists were challenged with identical samples which provides the prerequisite for comparability. Because there is no legal duress to undergo external proficiency testing in histopathology, all laboratories that took part volunteered to do so. These innovative quality assurance trials (Qualitätsinitiative Pathologie, QuIP) will be continued in the future on an annual or bi-annual basis. Participation is recommended for pathology departments involved in the service for breast units. The organisational frame work of the trials is described here.

  7. A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality.

    Science.gov (United States)

    Diaz-Ordaz, Karla; Froud, Robert; Sheehan, Bart; Eldridge, Sandra

    2013-10-22

    Previous reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this review, our aim was to assess the quality of cluster randomised trials conducted in residential facilities for older people, and to determine whether (1) statistician involvement in the trial and (2) strength of journal endorsement of the Consolidated Standards of Reporting Trials (CONSORT) statement influence quality. We systematically identified trials randomising residential facilities for older people, or parts thereof, without language restrictions, up to the end of 2010, using National Library of Medicine (Medline) via PubMed and hand-searching. We based quality assessment criteria largely on the extended CONSORT statement for cluster randomised trials. We assessed statistician involvement based on statistician co-authorship, and strength of journal endorsement of the CONSORT statement from journal websites. 73 trials met our inclusion criteria. Of these, 20 (27%) reported accounting for clustering in sample size calculations and 54 (74%) in the analyses. In 29 trials (40%), methods used to identify/recruit participants were judged by us to have potentially caused bias or reporting was unclear to reach a conclusion. Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials. Trials with statistician/epidemiologist co-authors were more likely to account for clustering in sample size calculations (unadjusted odds ratio 5.4, 95% confidence interval 1.1 to 26.0) and analyses (unadjusted OR 3.2, 1.2 to 8.5). Journal endorsement of the CONSORT statement was not associated with trial quality. Despite international attempts to improve

  8. Physical and technical quality assurance in the CHARTWEL-bronchus trial

    International Nuclear Information System (INIS)

    Lehmann, D.; Voigtmann, L.; Herrmann, T.; Baumann, M.; Leetz, H.K.; Hodapp, N.

    2003-01-01

    Background: On-site physical quality assurance (QA) was performed in the participating centers of the CHARTWEL-Bronchus trial to ensure that physical and technical treatment parameters correspond with the requirements of this trial. Material and Methods: Questionnaires were sent to the clinics to obtain information on the equipment and in-house QA policies. In addition, two phantoms with drillings for an ionization chamber were shipped with detailed instructions for CT-based treatment planning of a fixed field (RW3 phantom) and a standardized isocentric 3-field technique (Rando trademark humanoid phantom). Using their routine treatment planning system, the participating centers performed point dose calculations for the isocenters in both phantoms and for defined points in the lungs and the spinal cord of the Rando trademark phantom. During the on-site visit, the doses in these points and the deviation of the actual monitor calibration from the internal reference value of the department were determined. In addition, relevant geometric parameters of the accelerator were checked. Results: In the RW3 phantom, the maximum dose deviations from the prescribed value were 3.5% without correction for the actual monitor calibration and 2.1% after correction. The maximum dose deviation in the isocenter of the Rando trademark phantom was 4.0%. To separate the influence of the treatment planning system on this deviation from other sources, all measurements in the Rando trademark phantom were corrected for the deviations determined in the RW3 phantom. After this correction, the maximum deviation was 3.0% in the isocenter. For the other measurement points, the largest dose deviation of 7% was found in the left lung. Deviations of geometric parameters were negligible in all audited departments. Conclusion: The CHARTWEL-Bronchus physical QA program revealed a high conformity of geometric and dosimetric parameters and valid dose calculations by the CT-based treatment planning systems

  9. High-quality remote interactive imaging in the operating theatre

    Science.gov (United States)

    Grimstead, Ian J.; Avis, Nick J.; Evans, Peter L.; Bocca, Alan

    2009-02-01

    We present a high-quality display system that enables the remote access within an operating theatre of high-end medical imaging and surgical planning software. Currently, surgeons often use printouts from such software for reference during surgery; our system enables surgeons to access and review patient data in a sterile environment, viewing real-time renderings of MRI & CT data as required. Once calibrated, our system displays shades of grey in Operating Room lighting conditions (removing any gamma correction artefacts). Our system does not require any expensive display hardware, is unobtrusive to the remote workstation and works with any application without requiring additional software licenses. To extend the native 256 levels of grey supported by a standard LCD monitor, we have used the concept of "PseudoGrey" where slightly off-white shades of grey are used to extend the intensity range from 256 to 1,785 shades of grey. Remote access is facilitated by a customized version of UltraVNC, which corrects remote shades of grey for display in the Operating Room. The system is successfully deployed at Morriston Hospital, Swansea, UK, and is in daily use during Maxillofacial surgery. More formal user trials and quantitative assessments are being planned for the future.

  10. Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

    Science.gov (United States)

    Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

    2014-08-01

    Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. High Efficiency, Illumination Quality OLEDs for Lighting

    Energy Technology Data Exchange (ETDEWEB)

    Joseph Shiang; James Cella; Kelly Chichak; Anil Duggal; Kevin Janora; Chris Heller; Gautam Parthasarathy; Jeffery Youmans; Joseph Shiang

    2008-03-31

    The goal of the program was to demonstrate a 45 lumen per watt white light device based upon the use of multiple emission colors through the use of solution processing. This performance level is a dramatic extension of the team's previous 15 LPW large area illumination device. The fundamental material system was based upon commercial polymer materials. The team was largely able to achieve these goals, and was able to deliver to DOE a 90 lumen illumination source that had an average performance of 34 LPW a 1000 cd/m{sup 2} with peak performances near 40LPW. The average color temperature is 3200K and the calculated CRI 85. The device operated at a brightness of approximately 1000cd/m{sup 2}. The use of multiple emission colors particularly red and blue, provided additional degrees of design flexibility in achieving white light, but also required the use of a multilayered structure to separate the different recombination zones and prevent interconversion of blue emission to red emission. The use of commercial materials had the advantage that improvements by the chemical manufacturers in charge transport efficiency, operating life and material purity could be rapidly incorporated without the expenditure of additional effort. The program was designed to take maximum advantage of the known characteristics of these material and proceeded in seven steps. (1) Identify the most promising materials, (2) assemble them into multi-layer structures to control excitation and transport within the OLED, (3) identify materials development needs that would optimize performance within multilayer structures, (4) build a prototype that demonstrates the potential entitlement of the novel multilayer OLED architecture (5) integrate all of the developments to find the single best materials set to implement the novel multilayer architecture, (6) further optimize the best materials set, (7) make a large area high illumination quality white OLED. A photo of the final deliverable is shown

  12. Global Harmonization of Quality Assurance Naming Conventions in Radiation Therapy Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Melidis, Christos, E-mail: christos.melidis@eortc.be [European Organization for the Research and Treatment of Cancer–Radiation Oncology Group (EORTC-ROG), Radiation Therapy Quality Assurance (RTQA), Brussels (Belgium); Bosch, Walther R. [Washington University, representing Advanced Technology Consortium, Radiation Oncology, St. Louis, Missouri (United States); Izewska, Joanna [Dosimetry Laboratory, International Atomic Energy Agency, Vienna (Austria); Fidarova, Elena; Zubizarreta, Eduardo [Applied Radiation Biology and Radiotherapy Section, International Atomic Energy Agency, Vienna (Austria); Ulin, Kenneth [Department of Radiation Oncology, University of Massachusetts Medical School, Representing Quality Assurance Review Center, Worcester, Massachusetts (United States); Ishikura, Satoshi [Department of Radiation Oncology, Juntendo University, Representing Japan Clinical Oncology Group, RTQA, Tokyo (Japan); Followill, David [Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Representing Radiological Physics Center, RTQA, Houston, Texas (United States); Galvin, James [Department of Radiation Oncology, Thomas Jefferson University, Representing Radiation Therapy Oncology Group, RTQA, Philadelphia, Pennsylvania (United States); Haworth, Annette [Department of Physical Sciences, Peter MacCallum Cancer Centre, Melbourne, representing TransTasman Radiation Oncology Group (TROG) Cancer Research, Newcastle (Australia); Besuijen, Deidre [North West Cancer Centre, Representing TROG Cancer Research, Newcastle (Australia); Clark, Clark H. [Department of Medical Physics, St. Luke' s Cancer Centre, Royal Surrey County Hospital, Guildford, Surrey and National Physical Laboratory, Teddington, Middlesex, representing Radiation Therapy Trials Quality Assurance (RTTQA) (United Kingdom); Miles, Elizabeth; Aird, Edwin [Mount Vernon Cancer Centre, Northwood, Middlesex representing RTTQA (United Kingdom); and others

    2014-12-01

    Purpose: To review the various radiation therapy quality assurance (RTQA) procedures used by the Global Clinical Trials RTQA Harmonization Group (GHG) steering committee members and present the harmonized RTQA naming conventions by amalgamating procedures with similar objectives. Methods and Materials: A survey of the GHG steering committee members' RTQA procedures, their goals, and naming conventions was conducted. The RTQA procedures were classified as baseline, preaccrual, and prospective/retrospective data capture and analysis. After all the procedures were accumulated and described, extensive discussions took place to come to harmonized RTQA procedures and names. Results: The RTQA procedures implemented within a trial by the GHG steering committee members vary in quantity, timing, name, and compliance criteria. The procedures of each member are based on perceived chances of noncompliance, so that the quality of radiation therapy planning and treatment does not negatively influence the trial measured outcomes. A comparison of these procedures demonstrated similarities among the goals of the various methods, but the naming given to each differed. After thorough discussions, the GHG steering committee members amalgamated the 27 RTQA procedures to 10 harmonized ones with corresponding names: facility questionnaire, beam output audit, benchmark case, dummy run, complex treatment dosimetry check, virtual phantom, individual case review, review of patients' treatment records, and protocol compliance and dosimetry site visit. Conclusions: Harmonized RTQA harmonized naming conventions, which can be used in all future clinical trials involving radiation therapy, have been established. Harmonized procedures will facilitate future intergroup trial collaboration and help to ensure comparable RTQA between international trials, which enables meta-analyses and reduces RTQA workload for intergroup studies.

  13. External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

    Science.gov (United States)

    Murphy, Sean C; Hermsen, Cornelus C; Douglas, Alexander D; Edwards, Nick J; Petersen, Ines; Fahle, Gary A; Adams, Matthew; Berry, Andrea A; Billman, Zachary P; Gilbert, Sarah C; Laurens, Matthew B; Leroy, Odile; Lyke, Kristen E; Plowe, Christopher V; Seilie, Annette M; Strauss, Kathleen A; Teelen, Karina; Hill, Adrian V S; Sauerwein, Robert W

    2014-01-01

    Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

  14. Analysis of high-quality modes in open chaotic microcavities

    International Nuclear Information System (INIS)

    Fang, W.; Yamilov, A.; Cao, H.

    2005-01-01

    We present a numerical study of the high-quality modes in two-dimensional dielectric stadium microcavities. Although the classical ray mechanics is fully chaotic in a stadium billiard, all of the high-quality modes show a 'strong scar' around unstable periodic orbits. When the deformation (ratio of the length of the straight segments over the diameter of the half circles) is small, the high-quality modes correspond to whispering-gallery-type trajectories and their quality factors decrease monotonically with increasing deformation. At large deformation, each high-quality mode is associated with multiple unstable periodic orbits. Its quality factor changes nonmonotonically with the deformation, and there exists an optimal deformation for each mode at which its quality factor reaches a local maximum. This unusual behavior is attributed to the interference of waves propagating along different constituent orbits that could minimize light leakage out of the cavity

  15. Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review.

    Science.gov (United States)

    Gohari, Faeze; Baradaran, Hamid Reza; Tabatabaee, Morteza; Anijidani, Shabnam; Mohammadpour Touserkani, Fatemeh; Atlasi, Rasha; Razmgir, Maryam

    2015-01-01

    To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran. Systematized review. We included RCTs conducted on diabetes mellitus in Iran. Animal studies, educational interventions, and non-randomized trials were excluded. We excluded duplicated publications reporting the same groups of participants and intervention. Two independent reviewers identify all eligible articles specifically designed data extraction form. We searched through international databases; Scopus, ProQuest, EBSCO, Science Direct, Web of Science, Cochrane Library, PubMed; and national databases (In Persian language) such as Magiran, Scientific Information Database (SID) and IranMedex from January 1995 to January of 2013 Two investigators assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statemen.t,. Discrepancies were resolved by third reviewer consulting. One hundred and eight five (185) studies were included and appraised. Half of them (55.7 %) were published in Iranian journals. Most (89.7 %) were parallel RCTs, and being performed on type2 diabetic patients (77.8 %). Less than half of the CONSORT items (43.2 %) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1 % mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8 % of trials report how blinding was applied. The findings of this study show that the quality of RCTs conducted in Iran in diabetes research seems suboptimal and the reporting is also incomplete however an increasing trend of improvement can be seen over time. Therefore, it is suggested Iranian researchers pay much more attention to design and methodological quality in conducting and reporting of diabetes RCTs.

  16. Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial)

    DEFF Research Database (Denmark)

    Park, J; Danielsen, A K; Angenete, E

    2018-01-01

    BACKGROUND: A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study...... was to compare health-related quality of life (HRQOL) following early versus late closure of a temporary ileostomy. METHODS: Early closure of a temporary ileostomy (at 8-13 days) was compared with late closure (at more than 12 weeks) in a multicentre RCT (EASY) that included patients who underwent rectal...... after resection using the European Organisation for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30 and QLQ-CR29 and Short Form 36 (SF-36®). RESULTS: There were 112 patients available for analysis. Response rates of the questionnaires were 82-95 per cent, except for EORTC QLQ-C30 at 12...

  17. High quality steel casting for energy technics

    International Nuclear Information System (INIS)

    Schuster, F.; Koefler, G.

    1982-01-01

    The casting of several chromium-molybdenum steels for steam and hydraulic turbines is discussed. Non-destructive testing of the castings is performed demonstrating the safety for use in nuclear technology. The effect of metallurgical parameters on steel casting quality, the heat treatment, and the effect of construction design on costs for fettling and repair weldings are considered. (Auth.)

  18. Iohexol and iopamidol myelography in the dog: a clinical trial comparing adverse effects and myelographic quality

    International Nuclear Information System (INIS)

    Widmer, W.R.; Blevins, W.E.; Jakovljevic, S.; Teclaw, R.F.; Han, C.M.; Hurd, C.D.

    1992-01-01

    In a blind clinical trial, adverse effects after iohexol and iopamidol myelography were evaluated in 151 dogs. Eighty-one dogs were given iohexol (240 mgI/ml) and 70 dogs were given iopamidol (200 mgI/ml) by pre-determined assignment. Each dog was evaluated postmyelographically for seizures, hyperthermia, prolonged recovery from anesthesia and intensification of pre-existing neural signs. Myelographic quality was evaluated with a subjective scoring method. In comparing iohexol and iopamidol groups, there was not a statistically significant difference in the incidence of adverse effects or in myelographic quality. Iopamidol and iohexol appeared to be equally efficacious for routine canine myelography

  19. Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

    Science.gov (United States)

    Sarapa, Nenad

    2007-09-01

    The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

  20. Effect of simulated dawn on quality of sleep – a community-based trial

    Directory of Open Access Journals (Sweden)

    Haukka Jari

    2003-10-01

    Full Text Available Abstract Background Morning light exposure administered as simulated dawn looks a promising method to treat Seasonal Affective Disorder, but it may moreover help with resetting the inaccurate organisation of body clock functions relative to sleep occurring in winter among people in general. Disturbances in sleep patterns are common and may compromise wellbeing even in the short term. Our hypothesis was that simulated dawn could improve the subjective quality of sleep during winter. Methods A community-based trial with 100 volunteer subjects provided with dawn simulators. Study period lasted for eight weeks, and subjects used the dawn simulators for two weeks at a time, each subject acting as his own control (ABAB-design. Main outcome measure was subjective quality of sleep recorded each morning with Groningen Sleep Quality Scale. Results 77 subjects completed the trial. Quality of sleep improved while subjects were using dawn simulator-devices (p = 0.001. The treatment became beneficial after six days' use of dawn simulator, but the effect did not last after the use was ceased. Conclusion Dawn simulation may help to improve the subjective quality of sleep, but the benefits are modest. Further research is needed to verify these findings and to elucidate the mechanism by which dawn simulation acts on the sleep-wake pattern.

  1. Additive effects of word frequency and stimulus quality: the influence of trial history and data transformations.

    Science.gov (United States)

    Balota, David A; Aschenbrenner, Andrew J; Yap, Melvin J

    2013-09-01

    A counterintuitive and theoretically important pattern of results in the visual word recognition literature is that both word frequency and stimulus quality produce large but additive effects in lexical decision performance. The additive nature of these effects has recently been called into question by Masson and Kliegl (in press), who used linear mixed effects modeling to provide evidence that the additive effects were actually being driven by previous trial history. Because Masson and Kliegl also included semantic priming as a factor in their study and recent evidence has shown that semantic priming can moderate the additivity of word frequency and stimulus quality (Scaltritti, Balota, & Peressotti, 2012), we reanalyzed data from 3 published studies to determine if previous trial history moderated the additive pattern when semantic priming was not also manipulated. The results indicated that previous trial history did not influence the joint influence of word frequency and stimulus quality. More important, and independent of Masson and Kliegl's conclusions, we also show how a common transformation used in linear mixed effects analyses to normalize the residuals can systematically alter the way in which two variables combine to influence performance. Specifically, using transformed, rather than raw reaction times, consistently produces more underadditive patterns. PsycINFO Database Record (c) 2013 APA, all rights reserved.

  2. Quality assurance in head and neck surgical oncology: EORTC 24954 trial on larynx preservation.

    Science.gov (United States)

    Leemans, C R; Tijink, B M; Langendijk, J A; Andry, G; Hamoir, M; Lefebvre, J L

    2013-09-01

    The Head and Neck Cancer Group (HNCG) of the EORTC conducted a quality assurance program in the EORTC 24954 trial on larynx preservation. In this multicentre study, patients with resectable advanced squamous cell carcinoma of the larynx or hypopharynx were randomly assigned for treatment with sequential or alternating chemoradiation. The need for a quality assurance program is the evaluation and prevention of differences in treatments between centres in this multidisciplinary study. The surgical subcommittee of the HNCG prepared a questionnaire, and clinical records of all patients were verified during audits of independent teams. Data relating institutional practices were collected during a face to face interview with members of the local team. 271 clinical records from the nine main contributing centres were reviewed. The main difference between centres was the time interval between first consultation and treatment initiation, with a mean of 45 days. On the pathology report the nodal involvement was described by level in 36% of the cases according to the American Academy of Otolaryngology-Head and Neck Surgery classification. Extranodal spread was not always described in neck dissection specimens. The EORTC 24954 trial on larynx preservation was the first prospective trial with a quality assurance program in head and neck surgical oncology. The analysis shows similarities in practices, but also points out some important differences between centres. Operation reports were fairly complete, but uniformity in pathology reports should be improved. Copyright © 2013 Elsevier Ltd. All rights reserved.

  3. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

    DEFF Research Database (Denmark)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

    2016-01-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...

  4. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  5. Indoor Air Quality in High Performance Schools

    Science.gov (United States)

    High performance schools are facilities that improve the learning environment while saving energy, resources, and money. The key is understanding the lifetime value of high performance schools and effectively managing priorities, time, and budget.

  6. Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N. Venkatesh; Krishnan, K. Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E.; O’Brien, Kieran S.; Ray, Kathryn J.; McLeod, Stephen D.; Porco, Travis C.; Lietman, Thomas M.; Acharya, Nisha R.; Keenan, Jeremy D.

    2016-01-01

    IMPORTANCE Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. OBJECTIVE To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. DESIGN, SETTING, AND PARTICIPANTS Secondary analysis (performed October 11–25, 2014) of a double-masked, multicenter, randomized, active comparator–controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3–1.3). INTERVENTIONS Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. MAIN OUTCOMES AND MEASURES Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. RESULTS A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1–8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle–corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9–14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, −3.9 to 6.9]; P

  7. Analysis of the Quality of Clinical Trials Published in Spanish-Language Dermatology Journals Between 1997 and 2012.

    Science.gov (United States)

    Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

    2016-01-01

    The value of randomized clinical trials (RCTs) undertaken to identify an association between an intervention and an outcome is determined by their quality and scientific rigor. To assess the methodological quality of RCTs published in Spanish-language dermatology journals. By way of a systematic manual search, we identified all the RCTs in journals published in Spain and Latin America between 1997 (the year in which the CONSORT statement was published) and 2012. Risk of bias was evaluated for each RCT by assessing the following domains: randomization sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up. Source of funding and conflict of interest statements, if any, were recorded for each study. The search identified 70 RCTs published in 21 journals. Most of the RCTs had a high risk of bias, primarily because of gaps in the reporting of important methodological aspects. The source of funding was reported in only 15 studies. In spite of the considerable number of Spanish and Latin American journals, few RCTs have been published in the 15 years analyzed. Most of the RCTs published had serious defects in that the authors omitted methodological information essential to any evaluation of the quality of the trial and failed to report sources of funding or possible conflicts of interest for the authors involved. Authors of experimental clinical research in dermatology published in Spain and Latin America need to substantially improve both the design of their trials and the reporting of results. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

  8. Assessing quality of reports on randomized clinical trials in nursing journals.

    Science.gov (United States)

    Parent, Nicole; Hanley, James A

    2009-01-01

    Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

  9. Quality of clinical trials for selected priority mental and neurological disorders in sub-Saharan Africa: a systematic review

    Directory of Open Access Journals (Sweden)

    Mulugeta A

    2016-12-01

    Full Text Available Anwar Mulugeta,1 Girmay Medhin,2 Getnet Yimer,1 Rahimush Jemal,3 Abebaw Fekadu,4,5 1Department of Pharmacology, School of Medicine, College of Health Sciences, Addis Ababa University, 2Aklilu Lemma Institute of Pathobiology, Addis Ababa University, 3Department of Pharmacy, Tikur Anbesa Hospital, 4Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; 5Department of Psychological Medicine, Centre for Affective Disorders, Institute of Psychiatry, King’s College London, London, UK Background: There is a developing consensus on the effectiveness of various interventions for mental disorders in low- and middle-income countries, and it has been proposed that the main task is to scale up these interventions. In this context, we aimed to review the quality and extent of intervention trials for selected priority mental and neurological disorders in sub-Saharan Africa.Methods: Medline and African Journals Online databases were used for searching relevant articles. Both randomized and nonrandomized clinical trials for the treatment of schizophrenia, depression, maternal depression, bipolar disorder, and epilepsy/seizure disorders that involve pharmacotherapy, psychotherapy, and physical therapy were included. An extensive list of search terms that identified locations, disorders, interventions, and study types were employed. The qualities of the trials were appraised using the single-component quality assessment of the consolidated standards of reporting trials (CONSORT statement and the Jadad scale.Results: From 1,136 studies identified, only 34 trials that fulfilled inclusion criteria were used for quality analysis. Most studies were clinical trials of treatments for epilepsy and were conducted after 2006. In terms of region, the majority of studies were conducted in South Africa (22 of the 34 studies. Approximately half of the trials (53% were conducted in single center and the majority

  10. Quality of diets with fludized bed combustion residue treatment: II. Swine trials

    Energy Technology Data Exchange (ETDEWEB)

    Whitsel, T.J.; Reid, R.L.; Stout, W.L.; Hern, J.L.; Bennett, O.L.

    Growing pigs (Sus scrofa domesticus) were fed for an 8-wk period in two trials on diets produced on soils treated with fluidized bed combustion residue (FBCR) or limestone. Diets contained corn (Zea mays L.) and wheat (Triticum aestivum L.) mixtures with soybean (Glycine max (L.) Merr.) meal, supplemented with vegetables, fruits, and meat. Pigs were fed ad libitum and effects of diet treatment on rate of gain, N balance, blood composition, and element composition of the carcass and organs were determined. The FBCR diet caused a decrease (P<0.05 in Trial 1, P <0.07 in Trial 2) in body weight gains of pigs, but increased (P<0.05) N retention in one trial. Blood composition was not influenced markedly by diet treatment, with small but significant differences in serum Ca, triglycerides, certain amino acids, and whole blood Pb concentrations; effects were not consistent between trials. Urinary As concentration was slightly higher for pigs on FBCR diets. Analysis of the carcass and organs of pigs slaughtered posttrial showed significant differences in element levels from those of pretrial animals, but differences in tissue mineral concentrations related to diet treatment were few and inconsistent. Element concentrations in the organs of pigs were within normal ranges. No explanation for the depression in weight gain of pigs fed FBCR-treated diets was found. Except for the weight response, results support data from other trials with laboratory animals showing no apparent adverse effects of FBCR application to soils on nutritive quality of foods. 24 refs., 1 fig., 10 tabs.

  11. Extracting DNA from 'jaws': High yield and quality from archived tiger shark (Galeocerdo cuvier) skeletal material

    DEFF Research Database (Denmark)

    Eg Nielsen, Einar; Morgan, J. A T; Maher, S. L.

    2017-01-01

    of tiger sharks (Galeocerdo cuvier). Protocols were compared for DNA yield and quality using a qPCR approach. For jaw swarf, all methods provided relatively high DNA yield and quality, while large differences in yield between protocols were observed for vertebrae. Similar results were obtained from samples...... observed, likely reflecting different preparation and storage methods for the trophies. Trial sequencing of DNA capture genomic libraries using 20 000 baits revealed that a significant proportion of captured sequences were derived from tiger sharks. This study demonstrates that archived shark jaws...

  12. Randomized Controlled Trial on the Effects of CCTV Training on Quality of Life, Depression, and Adaptation to Vision Loss

    NARCIS (Netherlands)

    Burggraaff, M.C.; van Nispen, R.M.A.; Knol, D.L.; Ringens, P.J.; van Rens, G.H.M.B.

    2012-01-01

    PURPOSE. In addition to performance-based measures, visionrelated quality of life (QOL) and other subjective measures of psychosocial functioning are considered important outcomes of training in the visually impaired. In a multicenter, masked, randomized controlled trial, subjective effects of

  13. Do authors report surgical expertise in open spine surgery related randomized controlled trials? A systematic review on quality of reporting

    NARCIS (Netherlands)

    van Oldenrijk, Jakob; van Berkel, Youri; Kerkhoffs, Gino M. M. J.; Bhandari, Mohit; Poolman, Rudolf W.

    2013-01-01

    A systematic review of published trials in orthopedic spine literature. To determine the quality of reporting in open spine surgery randomized controlled trials (RCTs) between 2005 and 2010 with special focus on the reporting of surgical skill or expertise. In technically demanding procedures such

  14. [Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

    Science.gov (United States)

    Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

    2016-11-01

    To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles

  15. Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials

    Science.gov (United States)

    Bekelman, Justin E.; Deye, James A.; Vikram, Bhadrasain; Bentzen, Soren M.; Bruner, Deborah; Curran, Walter J.; Dignam, James; Efstathiou, Jason A.; FitzGerald, T. J.; Hurkmans, Coen; Ibbott, Geoffrey S.; Lee, J. Jack; Merchant, Timothy E.; Michalski, Jeff; Palta, Jatinder R.; Simon, Richard; Ten Haken, Randal K.; Timmerman, Robert; Tunis, Sean; Coleman, C. Norman; Purdy, James

    2012-01-01

    Background In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute (NCI) sponsored a two day workshop to examine the challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. Lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities like proton beam therapy, and the international harmonization of clinical trial QA. Results Four recommendations were made: 1) Develop a tiered (and more efficient) system for radiotherapy QA and tailor intensity of QA to clinical trial objectives. Tiers include (i) general credentialing, (ii) trial specific credentialing, and (iii) individual case review; 2) Establish a case QA repository; 3) Develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and 4) Explore the feasibility of consolidating clinical trial QA in the United States. Conclusion Radiotherapy QA may impact clinical trial accrual, cost, outcomes and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. PMID:22425219

  16. Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal.

    Science.gov (United States)

    Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M Juliana; Hural, John

    2014-07-01

    The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure that viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×10(6)±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8-3.2×10(6) cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and a recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in

  17. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial

    DEFF Research Database (Denmark)

    Andersson, J; Angenete, E; Gellerstedt, M

    2013-01-01

    Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial.......Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial....

  18. A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Claustrat Bruno

    2010-06-01

    Full Text Available Abstract Background To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ in subjects with moderate to severe sleep disorders. Methods Randomized placebo-controlled trial, in a Population-based setting. Participants were adult patients 25 to 65 years old with a chronic primary insomnia who volunteered for the study. The tested intervention consisted of two soft gelatine capsules per day, containing either the dietary supplement (active group or olive oil (placebo group for a month. Subjects could also volunteer for two ancillary studies on melatonin and actigraphy. Evaluation criteria included i perception of the quality of sleep at the end of treatment using the LSEQ questionnaire, ii sleep efficiency measured by one-week actigraphic movement measurement performed before and during the treatment in a subsample of subjects, iii night melatonin and 6 sulfatoxymelatonin (aMT6S urine rates in a subsample of subjects. Results The average of Leeds score was similar in both groups (p = 0.95. A marked improvement in the quality of sleep was observed in both placebo (62% and active (65% group (p = 0.52. The evolution of urinary melatonin, aMT6S, and of the Mel/aMT6S ratio showed no differences between the two groups. Sleep efficiency, as measured by actigraphy, improved similarly in both groups during the treatment period, from 72% to 76% and 75% in the active and placebo group respectively (p = 0.91. Conclusions The dietary supplement had neither effect on the perceived quality of sleep, nor on the melatonin metabolism and sleep-wake cycle. Trial registration: clinical trials.gov:NCT00484497

  19. Quality Assurance Issues in Conducting Multi-Institutional Advanced Technology Clinical Trials

    International Nuclear Information System (INIS)

    Purdy, James A.

    2008-01-01

    The National Cancer Institute-sponsored Advanced Technology Quality Assurance (QA) Consortium, which consisted of the Image-Guided Therapy QA Center, Radiation Therapy Oncology Group, Radiological Physics Center, Quality Assurance Review Center, and Resource Center for Emerging Technologies, has pioneered the development of an infrastructure and QA method for advanced technology clinical trials that requires volumetric digital data submission of a protocol patient's treatment plan and verification data. In particular, the Image-Guided Therapy QA Center has nearly 15 years experience in facilitating QA review for Radiation Therapy Oncology Group advanced technology clinical trials. This QA process includes (1) a data integrity review for completeness of protocol required elements, the format of data, and possible data corruption, and recalculation of dose-volume histograms; (2) a review of compliance with target volume and organ-at-risk contours by study chairs; and (3) a review of dose prescription and dose heterogeneity compliance by the Radiation Therapy Oncology Group Headquarters Dosimetry Group or the Radiological Physics Center dosimetrists (for brachytherapy protocols). This report reviews the lessons learned and the QA challenges presented by the use of advanced treatment modalities in clinical trials requiring volumetric digital data submission

  20. Multicentre quality assurance of intensity-modulated radiation therapy plans: a precursor to clinical trials

    International Nuclear Information System (INIS)

    Williams, M. J.; Bailey, M. J.; Forstner, D.; Metcalfe, P. E

    2007-01-01

    Full text: A multicentre planning study comparing intensity-modulated radiation therapy (IMRT) plans for the treatment of a head and neck cancer has been carried out. Three Australian radiotherapy centres, each with a different planning system, were supplied a fully contoured CT dataset and requested to generate an IMRT plan in accordance with the requirements of an IMRT-based radiation therapy oncology group clinical trial. Plan analysis was carried out using software developed specifically for reviewing multicentre clinical trial data. Two out of the three plans failed to meet the prescription requirements with one misinterpreting the prescription and the third failed to meet one of the constraints. Only one plan achieved all of the dose objectives for the critical structures and normal tissues. Although each centre used very similar planning parameters and beam arrangements the resulting plans were quite different. The subjective interpretation and application of the prescription and planning objectives emphasize one of the many difficulties in carrying out multicentre IMRT planning studies. The treatment prescription protocol in a clinical trial must be both lucid and unequivocally stated to avoid misinterpretation. Australian radiotherapy centres must show that they can produce a quality IMRT plan and that they can adhere to protocols for IMRT planning before using it in a clinical trial

  1. The measurement of health-related quality of life (QOL in paediatric clinical trials: a systematic review

    Directory of Open Access Journals (Sweden)

    Eiser Christine

    2004-11-01

    Full Text Available Abstract Background The goal of much care in chronic childhood illness is to improve quality of life (QOL. However, surveys suggest QOL measures are not routinely included. In addition, there is little consensus about the quality of many QOL measures. Objectives To determine the extent to which quality of life (QOL measures are used in paediatric clinical trials and evaluate the quality of measures used. Design Systematic literature review. Review Methods Included paediatric trials published in English between 1994 and 2003 involving children and adolescents up to the age of 20 years, and use of a standardised QOL measure. Data Sources included MEDLINE, CINAHL, EMB Reviews, AMED, BNI, PSYCHINFO, the Cochrane library, Internet, and reference lists from review articles. Results We identified 18 trials including assessment of QOL (4 Asthma, 4 Rhinitis, 2 Dermatitis, and single studies of Eczema, Cystic fibrosis, Otis media, Amblyopia, Diabetes, Obesity associated with a brain tumour, Idiopathic short stature, and Congenital agranulocytosis. In three trials, parents rated their own QOL but not their child's. Fourteen different QOL measures were used but only two fulfilled our minimal defined criteria for quality. Conclusions This review confirms previous reports of limited use of QOL measures in paediatric clinical trials. Our review provides information about availability and quality of measures which will be of especial value to trial developers.

  2. Quality Assurance Strategy for Existing Homes: Final Quality Management Primer for High Performing Homes

    Energy Technology Data Exchange (ETDEWEB)

    Del Bianco, M.; Taggart, J.; Sikora, J.; Wood, A.

    2012-12-01

    This guide is designed to help Building America (BA) Teams understand quality management and its role in transitioning from conventional to high performance home building and remodeling. It explains what quality means, the value of quality management systems, the unique need for QMS when building high performing homes, and the first steps to a implementing a comprehensive QMS. This document provides a framework and context for BA teams when they encounter builders and remodelers.

  3. Quality Assurance Strategy for Existing Homes. Final Quality Management Primer for High Performing Homes

    Energy Technology Data Exchange (ETDEWEB)

    Del Bianco, M. [NAHB Research Center Industry Partnership, Upper Marlboro, MD (United States); Taggart, J. [NAHB Research Center Industry Partnership, Upper Marlboro, MD (United States); Sikora, J. [NAHB Research Center Industry Partnership, Upper Marlboro, MD (United States); Wood, A. [NAHB Research Center Industry Partnership, Upper Marlboro, MD (United States)

    2012-12-01

    This guide is designed to help Building America (BA) teams understand quality management and its role in transitioning from conventional to high performance home building and remodeling. It explains what quality means, the value of quality management systems, the unique need for QMS when building high performing homes, and the first steps to a implementing a comprehensive QMS. This document provides a framework and context for BA teams when they encounter builders and remodelers.

  4. The Effect of Footbath on Sleep Quality of the Elderly: A Blinded Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Allehe Seyyedrasooli

    2013-11-01

    Full Text Available Introduction: The progressive increase in the elderly population of developing countries has drawn attention to their health. Sleep Pattern and quality can affect life quality in old people. We need more documents about footbath (a non-invasive method. The purpose of this research was to examine footbath on sleep quality of the elderly. Methods: This study is a blinded, randomized, clinical trial on 46 old men that had health documents in health center, 2013. Participants in the research were divided into two groups. One group had footbath (experimental group and another group did not have footbath (control group. The experimental group participants were asked to put their feet in warm water (41-42 ºC for 20 minutes before sleeping for 6 weeks. The co-researcher completed the Pittsburgh Sleep Quality Index (PSQI before and after the intervention by individual interview. Data were analyzed by SPSS software. Results: The comparison of changes in sleep quality score the old men showed the sleep duration and total sleep quality has significantly improved in the experimental group. Conclusion: According to the study results, the maximum effect of footbath was on sleep latency and sleep duration disturbances. In this study, the researchers had limited access to the elderly in Tabriz; therefore, it is recommended that future research be conducted in a higher number of health centers.

  5. Inequality in Preschool Quality? Community-Level Disparities in Access to High-Quality Learning Environments

    Science.gov (United States)

    Bassok, Daphna; Galdo, Eva

    2016-01-01

    In recent years, unequal access to high-quality preschool has emerged as a growing public policy concern. Because of data limitations, it is notoriously difficult to measure disparities in access to early learning opportunities across communities and particularly challenging to quantify gaps in access to "high-quality" programs. Research…

  6. A 3?week multimodal intervention involving high?intensity interval training in female cancer survivors: a randomized controlled trial

    OpenAIRE

    Schmitt, Joachim; Lindner, Nathalie; Reuss?Borst, Monika; Holmberg, Hans?Christer; Sperlich, Billy

    2016-01-01

    Abstract To compare the effects of a 3?week multimodal rehabilitation involving supervised high?intensity interval training (HIIT) on female breast cancer survivors with respect to key variables of aerobic fitness, body composition, energy expenditure, cancer?related fatigue, and quality of life to those of a standard multimodal rehabilitation program. A randomized controlled trial design was administered. Twenty?eight women, who had been treated for cancer were randomly assigned to either a ...

  7. Revisiting the Quality of Reporting Randomized Controlled Trials in Nursing Literature.

    Science.gov (United States)

    Adams, Yenupini Joyce; Kamp, Kendra; Liu, Cheng Ching; Stommel, Manfred; Thana, Kanjana; Broome, Marion E; Smith, Barbara

    2018-03-01

    To examine and update the literature on the quality of randomized controlled trials (RCTs) as reported in top nursing journals, based on manuscripts' adherence to the CONsolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive review of adherence of RCT manuscript to CONSORT guidelines. Top 40 International Scientific Indexing (ISI) ranked nursing journals that published 20 or more RCTs between 2010 and 2014, were included in the study. Selected articles were randomly assigned to four reviewers who assessed the quality of the articles using the CONSORT checklist. Data were analyzed using descriptive and inferential statistics. A total of 119 articles were included in the review. The mean CONSORT score significantly differed by journal but did not differ based on year of publication. The least consistently reported items included random allocation, who randomly assigned participants and whether those administering the interventions were blinded to group assignment. Although progress has been made, there is still room for improvement in the quality of RCT reporting in nursing journals. Special attention must be paid to how adequately studies adhere to the CONSORT prior to publication in nursing journals. Evidence from (RCTs) are thought to provide the best evidence for evaluating the impact of treatments and interventions by the U.S. Preventive Services Task Force. Since the evidence may be used for the development of clinical practice guidelines, it is critical that RCTs be designed, conducted, and reported appropriately and precisely. © 2017 Sigma Theta Tau International.

  8. Quality control for digital mammography: Part II recommendations from the ACRIN DMIST trial

    International Nuclear Information System (INIS)

    Yaffe, Martin J.; Bloomquist, Aili K.; Mawdsley, Gordon E.

    2006-01-01

    The Digital Mammography Imaging Screening Trial (DMIST), conducted under the auspices of the American College of Radiology Imaging Network (ACRIN), is a clinical trial designed to compare the accuracy of digital versus screen-film mammography in a screening population [E. Pisano et al., ACRIN 6652--Digital vs. Screen-Film Mammography, ACRIN (2001)]. Part I of this work described the Quality Control program developed to ensure consistency and optimal operation of the digital equipment. For many of the tests, there were no failures during the 24 months imaging was performed in DMIST. When systems failed, they generally did so suddenly rather than through gradual deterioration of performance. In this part, the utility and effectiveness of those tests are considered. This suggests that after verification of proper operation, routine extensive testing would be of minimal value. A recommended set of tests is presented including additional and improved tests, which we believe meet the intent and spirit of the Mammography Quality Standards Act regulations to ensure that full-field digital mammography systems are functioning correctly, and consistently producing mammograms of excellent image quality

  9. Reporting quality of randomized controlled trial abstracts: survey of leading general dental journals.

    Science.gov (United States)

    Hua, Fang; Deng, Lijia; Kau, Chung How; Jiang, Han; He, Hong; Walsh, Tanya

    2015-09-01

    The authors conducted a study to assess the reporting quality of randomized controlled trial (RCT) abstracts published in leading general dental journals, investigate any improvement after the release of the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts guidelines, and identify factors associated with better reporting quality. The authors searched PubMed for RCTs published in 10 leading general dental journals during the periods from 2005 to 2007 (pre-CONSORT period) and 2010 to 2012 (post-CONSORT period). The authors evaluated and scored the reporting quality of included abstracts by using the original 16-item CONSORT for Abstracts checklist. The authors used risk ratios and the t test to compare the adequate reporting rate of each item and the overall quality in the 2 periods. The authors used univariate and multivariate regressions to identify predictors of better reporting quality. The authors included and evaluated 276 RCT abstracts. Investigators reported significantly more checklist items during the post-CONSORT period (mean [standard deviation {SD}], 4.53 [1.69]) than during the pre-CONSORT period (mean [SD], 3.87 [1.10]; mean difference, -0.66 [95% confidence interval, -0.99 to -0.33]; P 80%). In contrast, the authors saw sufficient reporting of randomization, recruitment, outcome in the results section, and funding in none of the pre-CONSORT abstracts and less than 2% of the post-CONSORT abstracts. On the basis of the multivariate analysis, a higher impact factor (P general dental journals has improved significantly, but there is still room for improvement. Joint efforts by authors, reviewers, journal editors, and other stakeholders to improve the reporting of dental RCT abstracts are needed. Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

  10. Transient dynamics in trial-offer markets with social influence: Trade-offs between appeal and quality.

    Science.gov (United States)

    Altszyler, Edgar; Berbeglia, Franco; Berbeglia, Gerardo; Van Hentenryck, Pascal

    2017-01-01

    We study a trial-offer market where consumers may purchase one of two competing products. Consumer preferences are affected by the products quality, their appeal, and their popularity. While the asymptotic convergence or stationary states of these, and related dynamical systems, has been vastly studied, the literature regarding the transitory dynamics remains surprisingly sparse. To fill this gap, we derive a system of Ordinary Differential Equations, which is solved exactly to gain insight into the roles played by product qualities and appeals in the market behavior. We observe a logarithmic tradeoff between quality and appeal for medium and long-term marketing strategies: The expected market shares remain constant if a decrease in quality is followed by an exponential increase in the product appeal. However, for short time horizons, the trade-off is linear. Finally, we study the variability of the dynamics through Monte Carlo simulations and discover that low appeals may result in high levels of variability. The model results suggest effective marketing strategies for short and long time horizons and emphasize the significance of advertising early in the market life to increase sales and predictability.

  11. Transient dynamics in trial-offer markets with social influence: Trade-offs between appeal and quality.

    Directory of Open Access Journals (Sweden)

    Edgar Altszyler

    Full Text Available We study a trial-offer market where consumers may purchase one of two competing products. Consumer preferences are affected by the products quality, their appeal, and their popularity. While the asymptotic convergence or stationary states of these, and related dynamical systems, has been vastly studied, the literature regarding the transitory dynamics remains surprisingly sparse. To fill this gap, we derive a system of Ordinary Differential Equations, which is solved exactly to gain insight into the roles played by product qualities and appeals in the market behavior. We observe a logarithmic tradeoff between quality and appeal for medium and long-term marketing strategies: The expected market shares remain constant if a decrease in quality is followed by an exponential increase in the product appeal. However, for short time horizons, the trade-off is linear. Finally, we study the variability of the dynamics through Monte Carlo simulations and discover that low appeals may result in high levels of variability. The model results suggest effective marketing strategies for short and long time horizons and emphasize the significance of advertising early in the market life to increase sales and predictability.

  12. Transient dynamics in trial-offer markets with social influence: Trade-offs between appeal and quality

    Science.gov (United States)

    Altszyler, Edgar; Berbeglia, Franco; Van Hentenryck, Pascal

    2017-01-01

    We study a trial-offer market where consumers may purchase one of two competing products. Consumer preferences are affected by the products quality, their appeal, and their popularity. While the asymptotic convergence or stationary states of these, and related dynamical systems, has been vastly studied, the literature regarding the transitory dynamics remains surprisingly sparse. To fill this gap, we derive a system of Ordinary Differential Equations, which is solved exactly to gain insight into the roles played by product qualities and appeals in the market behavior. We observe a logarithmic tradeoff between quality and appeal for medium and long-term marketing strategies: The expected market shares remain constant if a decrease in quality is followed by an exponential increase in the product appeal. However, for short time horizons, the trade-off is linear. Finally, we study the variability of the dynamics through Monte Carlo simulations and discover that low appeals may result in high levels of variability. The model results suggest effective marketing strategies for short and long time horizons and emphasize the significance of advertising early in the market life to increase sales and predictability. PMID:28746334

  13. Pasta production: complexity in defining processing conditions for reference trials and quality assessment models

    Science.gov (United States)

    Pasta is a simple food made from water and durum wheat (Triticum turgidum subsp. durum) semolina. As pasta increases in popularity, studies have endeavored to analyze the attributes that contribute to high quality pasta. Despite being a simple food, the laboratory scale analysis of pasta quality is ...

  14. The effect of the amiodarone-warfarin interaction on anticoagulation quality in a single, high-quality anticoagulation center.

    Science.gov (United States)

    White, Ryan D; Riggs, Kyle W; Ege, Ed J; Petroski, Gregory F; Koerber, Scott M; Flaker, Greg

    2016-03-01

    Clinical trials have reported a low time in therapeutic range (TTR) in patients with atrial fibrillation treated with both warfarin andamiodarone. These trials included centers and countries with both high and low TTRs. What is the impact of amiodarone on the TTR in a single, high-quality anticoagulation clinic? TTR was assessed in amiodarone and nonamiodarone-treated patients from a University anticoagulation clinic. Baseline characteristics between patients ever-taking or never-taking amiodarone were similar, except more amiodarone patients were smokers (19.5 vs. 6.1%, P = 0.0031). The TTR calculated from 8901international normalized ratios (INRs) in 249 nonamiodarone patients with a mean follow-up of 34 ± 20 months (mean INR 36 ± 18) was 66 ± 16.6% compared with 61.3 ± 16.2% (P = 0.111) from 1455 INRs in 41 amiodarone-treated patients with a mean follow-up of 28 ± 20 months (mean INR 35 ± 22). Factors associated with a low TTR were male sex (P = 0.0013), smoker (P = 0.0048), and amiodarone use (P = 0.0374). A second on-treatment analysis, in which the TTR was calculated only during amiodarone therapy, resulted in similar findings; however, amiodarone did not emerge as a predictor of a low TTR. In 11 patients, the TTR prior to amiodarone (54.5 ± 22.2%) was not significantly different in the first 3 months (54.6 ± 33.4%) or after 3 months (67.2 ± 33.7%) of amiodarone. In a single high-quality anticoagulation center, anticoagulation quality, as measured by the TTR, can be comparable in amiodarone and nonamiodarone-treated patients.

  15. [On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

    Science.gov (United States)

    Li, Hong-Jiao; He, Li-Yun; Liu, Zhi-Shun; Sun, Ya-Nan; Yan, Shi-Yan; Liu, Jia; Zhao, Ye; Liu, Bao-Yan

    2014-02-01

    To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.

  16. Prediction of bread-making quality using size exclusion high ...

    African Journals Online (AJOL)

    Variation in the distribution of protein molecular weight in wheat (Triticum aestivum), influences breadmaking quality of wheat cultivars, resulting in either poor or good bread. The objective of this study was to predict breadmaking quality of wheat cultivars using size exclusion high performance liquid chromatography.

  17. Adoption and impact of high quality bambara flour (HQBF ...

    African Journals Online (AJOL)

    Adoption and impact of high quality bambara flour (HQBF) technology in the ... consumer acceptability/quality of products, credit, availability of raw materials, and ... as a result of 12.5 per cent increase in demand for bambara-based products.

  18. A critical appraisal of the reporting quality of published randomized controlled trials in the fall injuries.

    Science.gov (United States)

    Asghari Jafarabadi, Mohammad; Sadeghi-Bazrgani, Homayoun; Dianat, Iman

    2018-06-01

    To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved.

  19. The Effect of Orem's Self-Care Model on Quality of Life in Patients with Migraine: a Randomized Clinical Trial.

    Science.gov (United States)

    Mahmoudzadeh Zarandi, Fatemeh; Raiesifar, Afsaneh; Ebadi, Abbas

    2016-03-01

    Many aspects of the lives of migraineurs are commonly affected by the condition, including occupational affairs, social and family life, responsibilities and ultimately the quality of life. This study was designed to determine the effect of orem's self-care nursing model on quality of life in patients with a migraine. This study was carried out in Tehran, Iran. According to the pre-post design of the randomized clinical trial, 88 patients were selected. After obtaining approval from the ethics committee of the Baqiyatallah Medical Sciences University's Research Deputy; Patients who signed the informed consent aged 20-55 years and without any more disease or disability affecting the quality of life were selected and randomly assigned to a group. Data collection tools were a demographic questionnaire, general health survey short form (SF36), and Orem cognition form and self-care checklist. Self-care model were held as four 30-45 minutes training sessions based on self-care deficit needs for the experimental group. The quality of life scores was measured in two stages, before and three months after intervention then were compared in both groups. Data were analyzed with statistical software SPSS and use of descriptive analysis tests, Chi-square, Mann-Whitney u and Wilcoxon. The final analysis was performed on 43 experimental and 40 controls. No significant difference was detected in the two groups in terms of demographic variables (P>0.05). All dimensions of quality of life including physical functioning, physical role limitation, body pain, general health, vitality, social functioning and emotional role limitation and mental health in the experimental group showed a significant increase after intervention compared to the control group (Pmodel improves function and overall quality of life and reduces the high cost of a migraine and migraine-related disability to individuals and society.

  20. Study protocol of a multicenter randomized controlled trial of mindfulness training to reduce burnout and promote quality of life in police officers: the POLICE study.

    Science.gov (United States)

    Trombka, Marcelo; Demarzo, Marcelo; Bacas, Daniel Campos; Antonio, Sonia Beira; Cicuto, Karen; Salvo, Vera; Claudino, Felipe Cesar Almeida; Ribeiro, Letícia; Christopher, Michael; Garcia-Campayo, Javier; Rocha, Neusa Sica

    2018-05-25

    Police officers experience a high degree of chronic stress. Policing ranks among the highest professions in terms of disease and accident rates. Mental health is particularly impacted, evidenced by elevated rates of burnout, anxiety and depression, and poorer quality of life than the general public. Mindfulness training has been shown to reduce stress, anxiety, burnout and promote quality of life in a variety of settings, although its efficacy in this context has yet to be systematically evaluated. Therefore, this trial will investigate the efficacy of a mindfulness-based intervention versus a waitlist control in improving quality of life and reducing negative mental health symptoms in police officers. This multicenter randomized controlled trial has three assessment points: baseline, post-intervention, and six-month follow-up. Active police officers (n = 160) will be randomized to Mindfulness-Based Health Promotion (MBHP) or waitlist control group at two Brazilian major cities: Porto Alegre and São Paulo. The primary outcomes are burnout symptoms and quality of life. Consistent with the MBHP conceptual model, assessed secondary outcomes include perceived stress, anxiety and depression symptoms, and the potential mechanisms of resilience, mindfulness, decentering, self-compassion, spirituality, and religiosity. Findings from this study will inform and guide future research, practice, and policy regarding police offer health and quality of life in Brazil and globally. ClinicalTrials.gov NCT03114605 . Retrospectively registered on March 21, 2017.

  1. Quack: A quality assurance tool for high throughput sequence data.

    Science.gov (United States)

    Thrash, Adam; Arick, Mark; Peterson, Daniel G

    2018-05-01

    The quality of data generated by high-throughput DNA sequencing tools must be rapidly assessed in order to determine how useful the data may be in making biological discoveries; higher quality data leads to more confident results and conclusions. Due to the ever-increasing size of data sets and the importance of rapid quality assessment, tools that analyze sequencing data should quickly produce easily interpretable graphics. Quack addresses these issues by generating information-dense visualizations from FASTQ files at a speed far surpassing other publicly available quality assurance tools in a manner independent of sequencing technology. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  2. A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial.

    Science.gov (United States)

    Cornu, Catherine; Remontet, Laurent; Noel-Baron, Florence; Nicolas, Alain; Feugier-Favier, Nathalie; Roy, Pascal; Claustrat, Bruno; Saadatian-Elahi, Mitra; Kassaï, Behrouz

    2010-06-22

    To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in subjects with moderate to severe sleep disorders. Randomized placebo-controlled trial, in a Population-based setting. Participants were adult patients 25 to 65 years old with a chronic primary insomnia who volunteered for the study. The tested intervention consisted of two soft gelatine capsules per day, containing either the dietary supplement (active group) or olive oil (placebo group) for a month. Subjects could also volunteer for two ancillary studies on melatonin and actigraphy. Evaluation criteria included i) perception of the quality of sleep at the end of treatment using the LSEQ questionnaire, ii) sleep efficiency measured by one-week actigraphic movement measurement performed before and during the treatment in a subsample of subjects, iii) night melatonin and 6 sulfatoxymelatonin (aMT6S) urine rates in a subsample of subjects. The average of Leeds score was similar in both groups (p = 0.95). A marked improvement in the quality of sleep was observed in both placebo (62%) and active (65%) group (p = 0.52). The evolution of urinary melatonin, aMT6S, and of the Mel/aMT6S ratio showed no differences between the two groups. Sleep efficiency, as measured by actigraphy, improved similarly in both groups during the treatment period, from 72% to 76% and 75% in the active and placebo group respectively (p = 0.91). The dietary supplement had neither effect on the perceived quality of sleep, nor on the melatonin metabolism and sleep-wake cycle. clinical trials.gov:NCT00484497.

  3. Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

    Full Text Available Abstract Background ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. Methods The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query and "dirty" (any incomplete, inconsistent or illegible data. The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent and time delay (in days between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India and "Developed" (Italy, UK, Austria and Australia. Results There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month. The time interval for the receipt of data was longer for "Developing" countries (median:37 days compared to "Developed" ones (median:11 days (p Conclusions In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality. Trial registration ISRCTN46552265

  4. Innovative and high quality education through Open Education and OER

    OpenAIRE

    Stracke, Christian M.

    2017-01-01

    Online presentation and webinar by Stracke, C. M. (2017, 18 December) on "Innovative and high quality education through Open Education and OER" for the Belt and Road Open Education Learning Week by the Beijing Normal University, China.

  5. Improving high quality, equitable maternal health services in Malawi ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Improving high quality, equitable maternal health services in Malawi (IMCHA) ... In response, the Ministry of Health implemented a Standards-Based Management and Recognition for Reproductive Health initiative to improve ... Total funding.

  6. High Quality Education and Learning for All through Open Education

    NARCIS (Netherlands)

    Stracke, Christian M.

    2016-01-01

    Keynote at the International Lensky Education Forum 2016, Yakutsk, Republic of Sakha, Russian Federation, by Stracke, C. M. (2016, 16 August): "High Quality Education and Learning for All through Open Education"

  7. Comparison of Model Predictions of Image Quality with Results of Clinical Trials in Chest and Lumbar Spine Screen-film Imaging

    International Nuclear Information System (INIS)

    Sandborg, M.; McVey, G.; Dance, D.R.; Carlsson, G.A.

    2000-01-01

    The ability to predict image quality from known physical and technical parameters is a prerequisite for making successful dose optimisation. In this study, imaging systems have been simulated using a Monte Carlo model of the imaging systems. The model includes a voxelised human anatomy and quantifies image quality in terms of contrast and signal-to-noise ratio for 5-6 anatomical details included in the anatomy. The imaging systems used in clinical trials were simulated and the ranking of the systems by the model and radiologists compared. The model and the results of the trial for chest PA both show that using a high maximum optical density was significantly better than using a low one. The model predicts that a good system is characterised by a large dynamic range and a high contrast of the blood vessels in the retrocardiac area. The ranking by the radiologists and the model agreed for the lumbar spine AP. (author)

  8. Disseminating quality improvement: study protocol for a large cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    French Michael T

    2011-04-01

    Full Text Available Abstract Background Dissemination is a critical facet of implementing quality improvement in organizations. As a field, addiction treatment has produced effective interventions but disseminated them slowly and reached only a fraction of people needing treatment. This study investigates four methods of disseminating quality improvement (QI to addiction treatment programs in the U.S. It is, to our knowledge, the largest study of organizational change ever conducted in healthcare. The trial seeks to determine the most cost-effective method of disseminating quality improvement in addiction treatment. Methods The study is evaluating the costs and effectiveness of different QI approaches by randomizing 201 addiction-treatment programs to four interventions. Each intervention used a web-based learning kit plus monthly phone calls, coaching, face-to-face meetings, or the combination of all three. Effectiveness is defined as reducing waiting time (days between first contact and treatment, increasing program admissions, and increasing continuation in treatment. Opportunity costs will be estimated for the resources associated with providing the services. Outcomes The study has three primary outcomes: waiting time, annual program admissions, and continuation in treatment. Secondary outcomes include: voluntary employee turnover, treatment completion, and operating margin. We are also seeking to understand the role of mediators, moderators, and other factors related to an organization's success in making changes. Analysis We are fitting a mixed-effect regression model to each program's average monthly waiting time and continuation rates (based on aggregated client records, including terms to isolate state and intervention effects. Admissions to treatment are aggregated to a yearly level to compensate for seasonality. We will order the interventions by cost to compare them pair-wise to the lowest cost intervention (monthly phone calls. All randomized sites

  9. External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

    Directory of Open Access Journals (Sweden)

    Sean C Murphy

    Full Text Available Nucleic acid testing (NAT for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

  10. Predictors of acceptance of offered care management intervention services in a quality improvement trial for dementia.

    Science.gov (United States)

    Kaisey, Marwa; Mittman, Brian; Pearson, Marjorie; Connor, Karen I; Chodosh, Joshua; Vassar, Stefanie D; Nguyen, France T; Vickrey, Barbara G

    2012-10-01

    Care management approaches have been proven to improve outcomes for patients with dementia and their family caregivers (dyads). However, acceptance of services in these programs is incomplete, impacting effectiveness. Acceptance may be related to dyad as well as healthcare system characteristics, but knowledge about factors associated with program acceptance is lacking. This study investigates patient, caregiver, and healthcare system characteristics associated with acceptance of offered care management services. This study analyzed data from the intervention arm of a cluster randomized controlled trial of a comprehensive dementia care management intervention. There were 408 patient-caregiver dyads enrolled in the study, of which 238 dyads were randomized to the intervention. Caregiver, patient, and health system factors associated with participation in offered care management services were assessed through bivariate and multivariate regression analyses. Out of the 238 dyads, 9 were ineligible for this analysis, leaving data of 229 dyads in this sample. Of these, 185 dyads accepted offered care management services, and 44 dyads did not. Multivariate analyses showed that higher likelihood of acceptance of care management services was uniquely associated with cohabitation of caregiver and patient (p management participation could result in increased adoption of successful programs to improve quality of care. Using these factors to revise both program design as well as program promotion may also benefit external validity of future quality improvement research trials. Copyright © 2011 John Wiley & Sons, Ltd.

  11. Vision related quality of life in patients with type 2 diabetes in the EUROCONDOR trial

    DEFF Research Database (Denmark)

    Trento, Marina; Durando, Olga; Lavecchia, Sonia

    2017-01-01

    To evaluate vision related quality of life in the patients enrolled in The European Consortium for the Early Treatment of Diabetic Retinopathy, a clinical trial on prevention of diabetic retinopathy. Four-hundred-forty-nine patients, 153 women, with type 2 Diabetes and no or mild diabetic retinop...... acuity. The National Eye Institute Visual Functioning Questionnaire could detect subtle changes in patients' perception of visual function, despite absent/minimal diabetic retinopathy.......To evaluate vision related quality of life in the patients enrolled in The European Consortium for the Early Treatment of Diabetic Retinopathy, a clinical trial on prevention of diabetic retinopathy. Four-hundred-forty-nine patients, 153 women, with type 2 Diabetes and no or mild diabetic....... Diabetic retinopathy was absent in 193 (43.0 %) and mild in 256 (57.0 %). Patients without diabetic retinopathy were older, had shorter diabetes duration and used less insulin and glucose-lowering agents but did not differ by gender, best corrected visual acuity or any subscale, except vision specific...

  12. A Narrative Review of High-Quality Literature on the Effects of Resident Duty Hours Reforms.

    Science.gov (United States)

    Lin, Henry; Lin, Emery; Auditore, Stephanie; Fanning, Jon

    2016-01-01

    To summarize current high-quality studies evaluating the effect and efficacy of resident duty hours reforms (DHRs) on patient safety and resident education and well-being. The authors searched PubMed and Medline in August 2012 and again in May 2013 for literature (1987-2013) about the effects of DHRs. They assessed the quality of articles using the Medical Education Research Study Quality Instrument (MERSQI) scoring system. They considered randomized controlled trials (RCTs), partial RCTs, and all studies with a MERSQI score ≥ 14 to be "high-quality" methodology studies. A total of 72 high-quality studies met inclusion criteria. Most studies showed no change or slight improvement in mortality and complication rates after DHRs. Resident well-being was generally improved, but there was a perceived negative impact on education (knowledge acquisition, skills, and cognitive performance) following DHRs. Eleven high-quality studies assessed the impact of DHR interventions; all reported a neutral to positive impact. Seven high-quality studies assessed costs associated with DHRs and demonstrated an increase in hospital costs. The results of most studies that allow enough time for DHR interventions to take effect suggest a benefit to patient safety and resident well-being, but the effect on the quality of training remains unknown. Additional methodologically sound studies on the impact of DHRs are necessary. Priorities for future research include approaches to optimizing education and clinical proficiency and studies on the effect of intervention strategies on both education and patient safety. Such studies will provide additional information to help improve duty hours policies.

  13. Emblems of Quality in Higher Education. Developing and Sustaining High-Quality Programs.

    Science.gov (United States)

    Haworth, Jennifer Grant; Conrad, Clifton F.

    This book proposes an "engagement" theory of program quality to evaluate and improve higher education programs at all degree levels. Based on interviews with 781 participants in a national study of Masters degree programs, it focuses on the interactive roles of students, faculty, and administrators in developing high-quality programs…

  14. Magnitude of effects in clinical trials published in high-impact general medical journals.

    Science.gov (United States)

    Siontis, Konstantinos C M; Evangelou, Evangelos; Ioannidis, John P A

    2011-10-01

    Prestigious journals select for publication studies that are considered most important and informative. We aimed to examine whether high-impact general (HIG) medical journals systematically demonstrate more favourable results for experimental interventions compared with the rest of the literature. We scrutinized systematic reviews of the Cochrane Database (Issue 4, 2009) and meta-analyses published in four general journals (2008-09). Eligible articles included ≥1 binary outcome meta-analysis(es) pertaining to effectiveness with ≥1 clinical trial(s) published in NEJM, JAMA or Lancet. Effect sizes in trials from NEJM, JAMA or Lancet were compared with those from other trials in the same meta-analyses by deriving summary relative odds ratios (sRORs). Additional analyses examined separately early- and late-published trials in HIG journals and journal-specific effects. A total of 79 meta-analyses including 1043 clinical trials were analysed. Trials in HIG journals had similar effects to trials in other journals, when there was large-scale evidence, but showed more favourable results for experimental interventions when they were small. When HIG trials had less than 40 events, the sROR was 1.64 [95% confidence interval (95% CI): 1.23-2.18). The difference was most prominent when small early trials published in HIG journals were compared with subsequent trials [sROR 2.68 (95% CI: 1.33-5.38)]. Late-published HIG trials showed no consistent inflation of effects. The patterns did not differ beyond chance between NEJM, JAMA or Lancet. Small trials published in the most prestigious journals show more favourable effects for experimental interventions, and this is most prominent for early-published trials in such journals. No effect inflation is seen for large trials.

  15. High quality, high efficiency welding technology for nuclear power plants

    International Nuclear Information System (INIS)

    Aoki, Shigeyuki; Nagura, Yasumi

    1996-01-01

    For nuclear power plants, it is required to ensure the safety under the high reliability and to attain the high rate of operation. In the manufacture and installation of the machinery and equipment, the welding techniques which become the basis exert large influence to them. For the purpose of improving joint performance and excluding human errors, welding heat input and the number of passes have been reduced, the automation of welding has been advanced, and at present, narrow gap arc welding and high energy density welding such as electron beam welding and laser welding have been put to practical use. Also in the welding of pipings, automatic gas metal arc welding is employed. As for the welding of main machinery and equipment, there are the welding of the joints that constitute pressure boundaries, the build-up welding on the internal surfaces of pressure vessels for separating primary water from them, and the sealing welding of heating tubes and tube plates in steam generators. These weldings are explained. The welding of pipings and the state of development and application of new welding methods are reported. (K.I.)

  16. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make...... a qualitative assessment of the reporting....

  17. Concrete Waste Recycling Process for High Quality Aggregate

    International Nuclear Information System (INIS)

    Ishikura, Takeshi; Fujii, Shin-ichi

    2008-01-01

    Large amount of concrete waste generates during nuclear power plant (NPP) dismantling. Non-contaminated concrete waste is assumed to be disposed in a landfill site, but that will not be the solution especially in the future, because of decreasing tendency of the site availability and natural resources. Concerning concrete recycling, demand for roadbeds and backfill tends to be less than the amount of dismantled concrete generated in a single rural site, and conventional recycled aggregate is limited of its use to non-structural concrete, because of its inferior quality to ordinary natural aggregate. Therefore, it is vital to develop high quality recycled aggregate for general uses of dismantled concrete. If recycled aggregate is available for high structural concrete, the dismantling concrete is recyclable as aggregate for industry including nuclear field. Authors developed techniques on high quality aggregate reclamation for large amount of concrete generated during NPP decommissioning. Concrete of NPP buildings has good features for recycling aggregate; large quantity of high quality aggregate from same origin, record keeping of the aggregate origin, and little impurities in dismantled concrete such as wood and plastics. The target of recycled aggregate in this development is to meet the quality criteria for NPP concrete as prescribed in JASS 5N 'Specification for Nuclear Power Facility Reinforced Concrete' and JASS 5 'Specification for Reinforced Concrete Work'. The target of recycled aggregate concrete is to be comparable performance with ordinary aggregate concrete. The high quality recycled aggregate production techniques are assumed to apply for recycling for large amount of non-contaminated concrete. These techniques can also be applied for slightly contaminated concrete dismantled from radiological control area (RCA), together with free release survey. In conclusion: a technology on dismantled concrete recycling for high quality aggregate was developed

  18. Quality of life after radiation therapy of cerebral low-grade gliomas of the adult: results of a randomised Phase III trial on dose response (EORTC trial 22844)

    Energy Technology Data Exchange (ETDEWEB)

    Kiebert, G.M. [MEDTAP International, 27 Gilbert Street, London (United Kingdom); Curran, D. [EORTC Data Centre Brussels (Belgium); Aaronson, N.K. [The Netherlands Cancer Institute, Amsterdam (Netherlands); Bolla, M. [Centre Hospitalier Regional Universitaire, Grenoble (France); Menten, J. [University Hospital Gasthuisberg Leuven (Belgium); Rutten, E.H.J.M. [University Hospital St. Radboud, Nijmegen (Netherlands); Nordman, E. [Turku University Central Hospital, Turku (Finland); Silvestre, M.E. [Hospital Santa Maria, Lisbon (Portugal); Pierart, M. [EORTC Data Centre, Brussels (Belgium); Karim, A.B.M.F. [Free University Hospital, Amsterdam (Netherlands)

    1998-11-01

    In 1985, the EORTC Radiotherapy Co-operative Group launched a randomised phase III study comparing high-dose (59.4 Gy in 6.5 weeks) versus low-dose (45 Gy in 5 weeks) radiotherapy with conventional techniques in patients diagnosed with low-grade cerebral glioma. The primary endpoint of the study was survival. No difference in survival was observed between the two treatment strategies. A quality of life (QoL) questionnaire consisting of 47 items assessing a range of physical, psychological, social, and symptom domains was included in the trial to measure the impact of treatment over time. Patients who received high-dose radiotherapy tended to report lower levels of functioning and more symptom burden following completion of radiotherapy. These group differences were statistically significant for fatigue/malaise and insomnia immediately after radiotherapy and in leisure time and emotional functioning at 7-15 months after randomisation. These findings suggest that for conventional radiotherapy for low-grade cerebral glioma, a schedule of 45 Gy in 5 weeks not only saves valuable resources, but also spares patients a prolonged treatment at no loss of clinical efficacy. (Copyright (c) 1998 Elsevier Science B.V., Amsterdam. All rights reserved.)

  19. Quality of life after radiation therapy of cerebral low-grade gliomas of the adult: results of a randomised Phase III trial on dose response (EORTC trial 22844)

    International Nuclear Information System (INIS)

    Kiebert, G.M.; Curran, D.; Aaronson, N.K.; Bolla, M.; Menten, J.; Rutten, E.H.J.M.; Nordman, E.; Silvestre, M.E.; Pierart, M.; Karim, A.B.M.F.

    1998-01-01

    In 1985, the EORTC Radiotherapy Co-operative Group launched a randomised phase III study comparing high-dose (59.4 Gy in 6.5 weeks) versus low-dose (45 Gy in 5 weeks) radiotherapy with conventional techniques in patients diagnosed with low-grade cerebral glioma. The primary endpoint of the study was survival. No difference in survival was observed between the two treatment strategies. A quality of life (QoL) questionnaire consisting of 47 items assessing a range of physical, psychological, social, and symptom domains was included in the trial to measure the impact of treatment over time. Patients who received high-dose radiotherapy tended to report lower levels of functioning and more symptom burden following completion of radiotherapy. These group differences were statistically significant for fatigue/malaise and insomnia immediately after radiotherapy and in leisure time and emotional functioning at 7-15 months after randomisation. These findings suggest that for conventional radiotherapy for low-grade cerebral glioma, a schedule of 45 Gy in 5 weeks not only saves valuable resources, but also spares patients a prolonged treatment at no loss of clinical efficacy. (Copyright (c) 1998 Elsevier Science B.V., Amsterdam. All rights reserved.)

  20. Are reports of randomized controlled trials improving over time? A systematic review of 284 articles published in high-impact general and specialized medical journals.

    Science.gov (United States)

    To, Matthew J; Jones, Jennifer; Emara, Mohamed; Jadad, Alejandro R

    2013-01-01

    Inadequate reporting undermines findings of randomized controlled trials (RCTs). This study assessed and compared articles published in high-impact general medical and specialized journals. Reports of RCTs published in high-impact general and specialized medical journals were identified through a search of MEDLINE from January to March of 1995, 2000, 2005, and 2010. Articles that provided original data on adult patients diagnosed with chronic conditions were included in the study. Data on trial characteristics, reporting of allocation concealment, quality score, and the presence of a trial flow diagram were extracted independently by two reviewers, and discrepancies were resolved by consensus or independent adjudication. Descriptive statistics were used for quantitative variables. Comparisons between general medical and specialized journals, and trends over time were performed using Chi-square tests. Reports of 284 trials were analyzed. There was a significantly higher proportion of RCTs published with adequate reporting of allocation concealment (p = 0.003), presentation of a trial flow diagram (pgeneral medical journals had higher quality scores than those in specialized journals (p = 0.001), reported adequate allocation concealment more often (p = 0.013), and presented a trial flow diagram more often (pjournals over the last fifteen years. These improvements are likely attributed to concerted international efforts to improve reporting quality such as CONSORT. There is still much room for improvement, especially among specialized journals.

  1. High-quality planar high-Tc Josephson junctions

    International Nuclear Information System (INIS)

    Bergeal, N.; Grison, X.; Lesueur, J.; Faini, G.; Aprili, M.; Contour, J.P.

    2005-01-01

    Reproducible high-T c Josephson junctions have been made in a rather simple two-step process using ion irradiation. A microbridge (1 to 5 μm wide) is firstly designed by ion irradiating a c-axis-oriented YBa 2 Cu 3 O 7-δ film through a gold mask such as the nonprotected part becomes insulating. A lower T c part is then defined within the bridge by irradiating with a much lower fluence through a narrow slit (20 nm) opened in a standard electronic photoresist. These planar junctions, whose settings can be finely tuned, exhibit reproducible and nearly ideal Josephson characteristics. This process can be used to produce complex Josephson circuits

  2. Imaging Mental Representations of Sex-Typed Bodies: The Effect of Number of Trials on Image Quality

    Directory of Open Access Journals (Sweden)

    David James Lick

    2013-07-01

    Full Text Available Sex categorization is a critical process in social perception. While psychologists have long theorized that perceivers have distinct mental representations of men and women that help them to achieve efficient sex categorizations, researchers have only recently begun using reverse-correlation to visualize the content of these mental representations. The present research addresses two issues concerning this relatively new methodological tool. First, previous studies of reverse-correlation have focused almost exclusively on perceivers’ mental representations of faces. Our study demonstrates that this technique can also be used to visualize mental representations of sex-typed bodies. Second, most studies of reverse-correlation have employed a relatively large number of trials (1,000+ to capture perceivers’ mental representations of a given category. Our study demonstrated that, at least for sex-typed representations of bodies, high quality reverse-correlation images can be obtained with as few as 100 trials. Overall, our findings enhance knowledge of reverse-correlation methodology in general and sex categorization in particular, providing new information for researchers interested in using this technique to understand the complex processes underlying social perception.

  3. A systematic review of the quality of randomized controlled trials in head and neck oncology surgery.

    Science.gov (United States)

    Carlton, Daniel A; Kocherginsky, Masha; Langerman, Alexander J

    2015-01-01

    To determine the quality of randomized controlled trials (RCTs) in head and neck surgery in which surgery was a primary intervention. Potential articles were identified in PubMed without publication date restrictions. Articles were scored using the CONSORT checklist and the relationship between the checklist score and whether the first and/or last authors were surgeons was investigated. Differences in the checklist score based on how many surgeons were among the first and last authors of the study were analyzed using the Kruskal-Wallis test. Fisher's exact test was used to examine if there was a significant difference of the reporting of individual items from the checklist between surgeons and nonsurgeons. A nonparametric trend test was used to determine whether there was a difference in the reporting of individual items based on whether there were none, one, or two surgeons among first and last authors. A total of 38 publications satisfied the inclusion criteria. There was a trend toward lower quality for studies in which surgeons were either first, last, or both first and last authors compared to studies that were first-authored and last-authored by nonsurgeons (P = 0.068). Nonsurgeons were more likely to report on critical elements regarding hypothesis, sample size determination, randomization, and eligibility of centers (P = 0.023-0.058). The quality of RCTs in head and neck surgery is poor. Improved training in conducting and reporting clinical research is needed in otolaryngology residencies. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

  4. A survey of radiotherapy quality control practice in the United Kingdom for the START trial

    International Nuclear Information System (INIS)

    Venables, Karen; Winfield, Elizabeth; Deighton, Amanda; Aird, Edwin; Hoskin, Peter

    2001-01-01

    Background and purpose: This paper compares the quality control checks performed in departments in the United Kingdom with those recommended by the Institute of Physics and Engineering in Medicine (IPEM) in Report 81. Method: The data were gathered by the quality assurance team for the START trial, during visits to individual departments. Data are compared with the frequencies suggested in IPEM report 81. Where applicable, data are also analyzed with respect to machine manufacturer. Results: All departments with linear accelerators check the output at least weekly for both photons and electrons, however 11% of departments do not perform a constancy check of the output on a daily basis. The majority of departments check flatness at gantry zero on a monthly basis. However 27% of departments never check at non-zero gantry angles. In 51% of departments no fluoroscopy checks are performed on simulators on a daily basis. Conclusion: The majority of departments are following the frequencies suggested in IPEM report 81 although there are a number of discrepancies particularly for simulators. Accelerator type needs to be considered when designing quality assurance checks. In many departments more time than is currently allocated is needed on equipment, particularly simulators, to complete all of the checks suggested in Report 81

  5. Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer.

    Science.gov (United States)

    Clark, C H; Miles, E A; Urbano, M T Guerrero; Bhide, S A; Bidmead, A M; Harrington, K J; Nutting, C M

    2009-07-01

    The purpose of this study was to compare conventional radiotherapy with parotid gland-sparing intensity-modulated radiation therapy (IMRT) using the PARSPORT trial. The validity of such a trial depends on the radiotherapy planning and delivery meeting a defined standard across all centres. At the outset, many of the centres had little or no experience of delivering IMRT; therefore, quality assurance processes were devised to ensure consistency and standardisation of all processes for comparison within the trial. The pre-trial quality assurance (QA) programme and results are described. Each centre undertook exercises in target volume definition and treatment planning, completed a resource questionnaire and produced a process document. Additionally, the QA team visited each participating centre. Each exercise had to be accepted before patients could be recruited into the trial. 10 centres successfully completed the quality assurance exercises. A range of treatment planning systems, linear accelerators and delivery methods were used for the planning exercises, and all the plans created reached the standard required for participation in this multicentre trial. All 10 participating centres achieved implementation of a comprehensive and robust IMRT programme for treatment of head and neck cancer.

  6. Key factors for a high-quality VR experience

    Science.gov (United States)

    Champel, Mary-Luc; Doré, Renaud; Mollet, Nicolas

    2017-09-01

    For many years, Virtual Reality has been presented as a promising technology that could deliver a truly new experience to users. The media and entertainment industry is now investigating the possibility to offer a video-based VR 360 experience. Nevertheless, there is a substantial risk that VR 360 could have the same fate as 3DTV if it cannot offer more than just being the next fad. The present paper aims at presenting the various quality factors required for a high-quality VR experience. More specifically, this paper will focus on the main three VR quality pillars: visual, audio and immersion.

  7. Process to Continuously Melt, Refine and Cast High Quality Steel

    Energy Technology Data Exchange (ETDEWEB)

    None

    2005-09-01

    The purpose of this project is to conduct research and development targeted at designing a revolutionary steelmaking process. This process will deliver high quality steel from scrap to the casting mold in one continuous process and will be safer, more productive, and less capital intensive to build and operate than conventional steelmaking. The new process will produce higher quality steel faster than traditional batch processes while consuming less energy and other resources.

  8. The use of induced mutation combined with crossing in high quality rice breeding

    Energy Technology Data Exchange (ETDEWEB)

    Do Huu At; Bui Huy Thuy; Nguyen Van Bich; Tran Duy Quy [Agricultural Genetics Institute, Division of Genetics and Hybrid Rice Technology, Hanoi (Viet Nam); Nguyen Minh Cong [Hanoi No. 1 Teacher Training Univ., Department of Genetics (Viet Nam)

    2001-03-01

    The high quality rice varieties: Tam thom mutant rice Var., DT17 rice Var, DT21 glutinous rice Var were formed by induced mutation combined with crossing. Tam thom mutant rice Var. lost photosensitivity, could be planted 2 crops/year. DT17 rice Var with high yielding capacity, suitable for growth on lowland in summer crop, is replacing step-by-step Moctuyen rice Var. in North Vietnam. DT21 glutinous rice Var. could be planted 2 crops/year and had short growth duration, average yield was 4.0-4.5 tons/ha. These three ones had good quality, soft and scent cooked rice, suitable for customers and export requirements. Tam thom mutant rice Var. DT17 rice Var., DT21 and glutinous rice Var. were adopted for regional production by Ministry of Agriculture and Rural Development and allowed to be in trial production. (author)

  9. The use of induced mutation combined with crossing in high quality rice breeding

    International Nuclear Information System (INIS)

    Do Huu At; Bui Huy Thuy; Nguyen Van Bich; Tran Duy Quy; Nguyen Minh Cong

    2001-01-01

    The high quality rice varieties: Tam thom mutant rice Var., DT17 rice Var, DT21 glutinous rice Var were formed by induced mutation combined with crossing. Tam thom mutant rice Var. lost photosensitivity, could be planted 2 crops/year. DT17 rice Var with high yielding capacity, suitable for growth on lowland in summer crop, is replacing step-by-step Moctuyen rice Var. in North Vietnam. DT21 glutinous rice Var. could be planted 2 crops/year and had short growth duration, average yield was 4.0-4.5 tons/ha. These three ones had good quality, soft and scent cooked rice, suitable for customers and export requirements. Tam thom mutant rice Var. DT17 rice Var., DT21 and glutinous rice Var. were adopted for regional production by Ministry of Agriculture and Rural Development and allowed to be in trial production. (author)

  10. Just Images. Television News Coverage of High-Profile Criminal Trials.

    Science.gov (United States)

    Trossman, Mindy S.

    This guide describes "Just Images" a series of television programs and exhibitions that offers a public forum for analyzing television's influential portrayals of trials, lawyers, and the legal system. Contending that television portrayals of high-profile trials has altered the public's perception of law and the role of lawyers in the legal…

  11. High-quality cardiopulmonary resuscitation: current and future directions.

    Science.gov (United States)

    Abella, Benjamin S

    2016-06-01

    Cardiopulmonary resuscitation (CPR) represents the cornerstone of cardiac arrest resuscitation care. Prompt delivery of high-quality CPR can dramatically improve survival outcomes; however, the definitions of optimal CPR have evolved over several decades. The present review will discuss the metrics of CPR delivery, and the evidence supporting the importance of CPR quality to improve clinical outcomes. The introduction of new technologies to quantify metrics of CPR delivery has yielded important insights into CPR quality. Investigations using CPR recording devices have allowed the assessment of specific CPR performance parameters and their relative importance regarding return of spontaneous circulation and survival to hospital discharge. Additional work has suggested new opportunities to measure physiologic markers during CPR and potentially tailor CPR delivery to patient requirements. Through recent laboratory and clinical investigations, a more evidence-based definition of high-quality CPR continues to emerge. Exciting opportunities now exist to study quantitative metrics of CPR and potentially guide resuscitation care in a goal-directed fashion. Concepts of high-quality CPR have also informed new approaches to training and quality improvement efforts for cardiac arrest care.

  12. Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

    Energy Technology Data Exchange (ETDEWEB)

    Driscoll, B. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Keller, H. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada and Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Jaffray, D.; Coolens, C. [Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada); Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada); Techna Institute, University Health Network, 124-100 College Street, Toronto, Ontario M5G 1L5 (Canada)

    2013-08-15

    Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producing predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from

  13. Information on blinding in registered records of clinical trials

    Directory of Open Access Journals (Sweden)

    Viergever Roderik F

    2012-11-01

    Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

  14. How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction)

    OpenAIRE

    Bidad, Natalie; MacDonald, Lindsay; Winters, Zoë E; Edwards, Sarah J L; Emson, Marie; Griffin, Clare L.; Bliss, Judith; Horne, Rob

    2016-01-01

    Background: Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have been methodologically limited. This study evaluated how women weigh up different motivations after initially expressing altruism, and explored their understanding of a trial and its alternatives. The trial was the 'Quality of Life after Mastectomy and Breast Reconstruction' (...

  15. [Interlaboratory trials for quality assurance of breast cancer biomarkers in Germany].

    Science.gov (United States)

    Krusche, C A; von Wasielewski, R; Rüschoff, J; Fisseler-Eckhoff, A; Kreipe, H H

    2008-07-01

    In the age of personalized medicine, and in addition to typing and grading, breast cancer pathologists are now also involved in determining biomarkers such as steroid hormone receptors and Her-2, which are of the utmost importance in adjuvant therapy. In order to assure quality of these biomarker assays, external proficiency testing has been implemented in Germany. Since 2002 trials have been conducted annually, with up to 180 participating laboratories. More than 85% of all participants achieved good results in clearly negative and positive cases seen in daily practice. If at all, discordant results were observed in the rarer low steroid-hormone receptor expressing tumors and Her-2 borderline cases (2+). Regular participation in interlaboratory testing leads to significantly improved immunohistochemical results, particularly in these problematic cases. Tissue microarrays (TMA) with 20-24 different breast cancer samples including cell lines meant that a huge number of pathologists were challenged with identical samples, providing the prerequisite for comparability. Participation is recommended for pathology departments involved in the service for breast units. The organizational frame work of the trials is described here. The confidence of cooperating disciplines in breast cancer biomarkers assessed by pathologists will be fostered by external proficiency testing as presented here.

  16. Pharmacist leadership in ICU quality improvement: coordinating spontaneous awakening and breathing trials.

    Science.gov (United States)

    Stollings, Joanna L; Foss, Julie J; Ely, E Wesley; Ambrose, Anna M; Rice, Todd W; Girard, Timothy D; Wheeler, Arthur P

    2015-08-01

    Coordinating efforts across disciplines in the intensive care unit is a key component of quality improvement (QI) efforts. Spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs) are considered key components of guidelines, yet unfortunately are often not done or coordinated properly. To determine if a pharmacist-driven awakening and breathing coordination (ABC) QI program would improve compliance (ie, process measures) as compared with the previous protocol, which did not involve pharmacists. The QI program included pharmacist-led education, daily discussion on rounds, and weekly performance reports to staff. Using a pre-QI versus during-QI versus post-QI intervention design, we compared data from 500 control ventilator-days (pre-QI period) versus 580 prospective ventilator-days (during-QI period). We then evaluated the sustainability of the QI program in 216 ventilator-days in the post-QI period. SAT safety screens were performed on only 20% pre-QI patient-days versus 97% of during-QI patient-days (P improved process measures compliance, comparing the pre-QI versus during-QI rates of screening, performing, and coordinating SAT and SBTs, and these results were sustained in the 8-month follow-up period post-QI program. © The Author(s) 2015.

  17. Next Generation High Quality Videoconferencing Service for the LHC

    CERN Multimedia

    CERN. Geneva

    2012-01-01

    In recent times, we have witnessed an explosion of video initiatives in the industry worldwide. Several advancements in video technology are currently improving the way we interact and collaborate. These advancements are forcing tendencies and overall experiences: any device in any network can be used to collaborate, in most cases with an overall high quality. To cope with this technology progresses, CERN IT Department has taken the leading role to establish strategies and directions to improve the user experience in remote dispersed meetings and remote collaboration at large in the worldwide LHC communities. Due to the high rate of dispersion in the LHC user communities, these are critically dependent of videoconferencing technology, with a need of robustness and high quality for the best possible user experience. We will present an analysis of the factors that influenced the technical and strategic choices to improve the reliability, efficiency and overall quality of the LHC remote sessions. In particular, ...

  18. Vision related quality of life in patients with type 2 diabetes in the EUROCONDOR trial.

    Science.gov (United States)

    Trento, Marina; Durando, Olga; Lavecchia, Sonia; Charrier, Lorena; Cavallo, Franco; Costa, Miguel Angelo; Hernández, Cristina; Simó, Rafael; Porta, Massimo

    2017-07-01

    To evaluate vision related quality of life in the patients enrolled in The European Consortium for the Early Treatment of Diabetic Retinopathy, a clinical trial on prevention of diabetic retinopathy. Four-hundred-forty-nine patients, 153 women, with type 2 Diabetes and no or mild diabetic retinopathy were enrolled in a 2-year multicenter randomized controlled trial. The 25-item National Eye Institute Visual Functioning Questionnaire was used to explore 12 subscales of vision related quality of life. The patients were 62.8 ± 6.7 years old and had 11.1 ± 5.6 years known disease duration. Diabetic retinopathy was absent in 193 (43.0 %) and mild in 256 (57.0 %). Patients without diabetic retinopathy were older, had shorter diabetes duration and used less insulin and glucose-lowering agents but did not differ by gender, best corrected visual acuity or any subscale, except vision specific mental health and vision specific role difficulties. Patients with reduced retinal thickness at the ganglion cell layer (n = 36) did not differ for diabetic retinopathy but were older, had lower best corrected visual acuity and worse scores for ocular pain, color vision and peripheral vision. On multivariable analysis, worse scores for general vision remained associated with reduced retinal thickness, diabetes duration and best corrected visual acuity, and scores for visual specific mental health with diabetic retinopathy and lower best corrected visual acuity. Visual specific role difficulties were only associated with reduced best corrected visual acuity. Scores for driving decreased among females, with worsening of Hemoglobin A1c and best corrected visual acuity. Color vision depended only on reduced retinal thickness, and peripheral vision on both reduced thickness and best corrected visual acuity. The National Eye Institute Visual Functioning Questionnaire could detect subtle changes in patients' perception of visual function, despite absent/minimal diabetic

  19. 167: CRITICALLY APPRAISE OF THE REPORTING QUALITY OF RANDOMIZED CONTROLLED TRIALS ARTICLES IN THE FIELD OF DIABETES IN MEDICAL GUIDELINES IN IRAN

    Science.gov (United States)

    Aletaha, Azadeh; Baradaran, Hamid Reza; Soltani, Akbar; Ramezani, Amir

    2017-01-01

    Background and aims To determine the quality of randomized controlled clinical trial reports in diabetes research in Iran and their presence in domestic and foreign credible guidelines which can imply whether randomized controlled trial articles in the field of diabetes are of good quality or not with respect to their high level of received citations, quality and credibility. Method We included RCTs conducted on Diabetes mellitus in Iran. Animal studies, educational, interventions, and non-randomized trials were excluded. This was a bibliographic study examining published journal articles involving RCTs in diabetes research from Iranian authors. A systematic search of ten databases(ISI Web of science, Scopus, PubMed, Science Direct, The Cochrane Library, Taylor & Francis Online, Biomed Central, EBSCO, ProQuest and OVID)were undertaken from July 2004–2014. We excluded duplicated publications reporting the same groups of participants and intervention two independent reviewers identify all eligible articles specifically designed data extraction form. Two reviewers assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statement and also evaluate each article with Scientometry tools in 260 valid English diabetes guidelines. Result Overall, we included 185 RCTs on diabetes mellitus, One hundred and eight five (185) studies were included and appraised. Half of them (55.7%) were published in Iranian journals. Most (89.7%) were parallel RCTs, and being performed on type2 diabetic patients (77.8%). Less than half of the CONSORT items (43.2%) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1% mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8% of trials report how blinding was applied. From 185 articles, twelve articles (10%) are presented in 260 Guidelines. Conclusion The reporting quality of abstracts of RCTs

  20. Health care in small prisons: incorporating high-quality standards.

    Science.gov (United States)

    Rieder, Jean-Pierre; Casillas, Alejandra; Mary, Gérard; Secretan, Anne-Dominique; Gaspoz, Jean-Michel; Wolff, Hans

    2013-01-01

    In the past, health management in Geneva's six post-trial prisons had been variable and inconsistent. In 2008, the unit of penitentiary medicine of the Geneva University Hospitals was mandated to re-organize and provide health care at all six prison facilities. The specific aim of this paper is to outline the example as a practical solution to some of the common challenges in unifying the structure and process of health services across multiple small facilities, while meeting European prison health and local quality standards. Geneva's post-trial prisons are small and close to one another in geographical proximity - ideal conditions for the construction of a health mobile team (HMT). This multidisciplinary mobile team operated like a community ambulatory care model; it was progressively launched in all prison facilities in Geneva. The authors incorporated an implementation strategy where health providers partnered with prison and community stakeholders in the health delivery model's development and adaption process. The model's strategic initiatives are described along the following areas, in light of other international prison health activity and prior care models: access to a health care professional, equivalence of care, patient consent, confidentiality, humanitarian interventions, and professional competence and independence. From the perspective of the HMT members, the authors provide the "lessons learned" through this experience, especially to providers who are working on prison health services reform and coordination improvement. The paper particularly stresses the importance of partnering with community health stakeholders and prison staff, a key component to the approach.

  1. IMPACT OF RESILIENCE, ICT SUPPORT AND QUALITY OF STUDENT'S LIFE ON QUALITY OF HIGH EDUCATION PROCESS

    Directory of Open Access Journals (Sweden)

    Zorica Lazic

    2016-12-01

    Full Text Available Answers to the questions of how and in what way the quality of life of students, resilience and ICT support affects the quality of high education we will get through this work where main objective is to define a network of processes and process management ensuring more quality and more innovative managing and service provision, therefore satisfying the needs of service users - in this case the students of the university. To collect the relevant data in the thematic analysis of this paper, the method of interviewing by questionnaires was applied. The sample survey was conducted among undergraduate students, teachers and staff of the Teacher Training Faculty in Uzice.

  2. Sleep quality in nurses: a randomized clinical trial of day and night shift workers.

    Science.gov (United States)

    Niu, Shu-Fen; Chu, Hsin; Chung, Min-Huey; Lin, Chun-Chieh; Chang, Yu-Shiun; Chou, Kuei-Ru

    2013-07-01

    The study investigated the number of days off nurses working night shifts need to recover their sleep quality to the level of daytime workers during their days off. This study included 30 day-shift nurses and 32 night-shift nurses. It was conducted as a randomized clinical trial in the medical and surgical wards of a medical center in northern Taiwan in May and June 2010 using sleep diaries and sleep parameters collected by actigraphy on different workdays and days off. On workdays, the night-shift group had significantly less total sleep time (TST) on Day 5 and significantly lower sleep efficiency (SE) on Day 3 than the day-shift group. TSTs of the two groups on days off were higher than those on workdays. On the 4th consecutive day off, higher TST, a decrease in WASO, and an increase in SE suggests that the night-shift group had recovered their sleep quality to the level of the day-shift group on their days off. The SE of the night-shift group exceeded that of the day-shift group after the 4th consecutive day off, though the difference was not statistically significant in the present study. Based on these data, it is recommended that night-shift workers arrange a period of at least 4 days off after 5 consecutive night shifts and at least 5 days off if the staff who have previously worked night shifts are being assigned a set of different shifts.

  3. CEC quality criteria for diagnostic radiographic images and patient exposure trial

    International Nuclear Information System (INIS)

    Nahrstedt, U.; Wall, B.; Maccia, C.; Moores, B.M.; Padovani, R.

    1990-01-01

    The intention of this report has been to present the results of a multinational trial set up by a study group of the radiation protection programme of the CEC. In view of proceeding towards the harmonization and the optimization of the radiological techniques commonly used in different European countries, the relevance of quality criteria for radiographic images together with dose requirements were checked on about 900 examined patients. Due to the type of X-ray projections considered, more than 1 200 questionnaires concerning the real X-ray films were therefore collected and evaluated through a scoring system. Such an approach was relevant and contributed to providing practical considerations on how to reduce and optimize patient received dose while keeping the essential medical information imaged on the film. Indeed the results obtained allowed identification of technical modalities corresponding to that objective. Furthermore, analysis of results revealed two main areas which should be further taken into consideration: - personnel training in radiation protection (radiologists and radiographers), establishment of quality assurance programmes in diagnostic radiology (good usage of radiological equipment and reduction of wasted films)

  4. Dose-Response Effects of Aerobic Exercise on Quality of Life in Postmenopausal Women: Results from the Breast Cancer and Exercise Trial in Alberta (BETA).

    Science.gov (United States)

    Courneya, Kerry S; McNeil, Jessica; O'Reilly, Rachel; Morielli, Andria R; Friedenreich, Christine M

    2017-06-01

    Exercise generally improves quality of life (QoL) and psychosocial functioning in adult populations but few randomized trials have examined dose-response effects. The purpose of the present study was to report the QoL and psychosocial outcomes from the Breast Cancer and Exercise Trial in Alberta (BETA). Healthy but inactive postmenopausal women at risk for breast cancer were randomized to a year-long aerobic exercise intervention consisting of either 150 min/week (moderate volume group, n = 200) or 300 min/week (high volume group, n = 200). QoL was assessed at baseline and 1 year using the short form-36 health survey. Sleep quality, depression, anxiety, stress, self-esteem, and happiness were also assessed. Participant preference for group assignment (i.e., exercise volume) was assessed at baseline and tested as a moderator. There were no statistically significant dose-response effects of aerobic exercise on any QoL, sleep quality, or psychosocial outcome. Participant preference for group assignment did not moderate any QoL, sleep quality, or psychosocial responses. Marital status was a significant moderator (p for interaction = 0.01) and obesity showed a trend towards being a moderator (p for interaction = 0.08) of the dose-response effects of aerobic exercise on global sleep quality such that unmarried and obese women improved sleep quality with the higher volume of aerobic exercise. A higher volume of aerobic exercise, approximately double the minimum public health guideline, did not provide additional QoL or psychosocial benefits compared to the minimum public health guideline in inactive postmenopausal women, even for women who preferred the higher volume of exercise at baseline. Trial Registration clinicaltrials.gov identifier: NCT1435005.

  5. Learning Disabilities and Achieving High-Quality Education Standards

    Science.gov (United States)

    Gartland, Debi; Strosnider, Roberta

    2017-01-01

    This is an official document of the National Joint Committee on Learning Disabilities (NJCLD), of which Council for Learning Disabilities is a long-standing, active member. With this position paper, NJCLD advocates for the implementation of high-quality education standards (HQES) for students with learning disabilities (LD) and outlines the…

  6. extraction of high quality dna from polysaccharides-secreting ...

    African Journals Online (AJOL)

    cistvr

    A DNA extraction method using CTAB was used for the isolation of genomic DNA from ten. Xanthomonas campestris pathovars, ten isolates of Xanthomonas albilineans and one isolate of. Pseudomonas rubrisubalbicans. High quality DNA was obtained that was ideal for molecular analy- ses. Extracellular polysaccharides ...

  7. Negative Binomial charts for monitoring high-quality processes

    NARCIS (Netherlands)

    Albers, Willem/Wim

    Good control charts for high quality processes are often based on the number of successes between failures. Geometric charts are simplest in this respect, but slow in recognizing moderately increased failure rates p. Improvement can be achieved by waiting until r > 1 failures have occurred, i.e. by

  8. Synthesis and spectroscopic study of high quality alloy Cdx S ...

    Indian Academy of Sciences (India)

    Wintec

    In the present study, we report the synthesis of high quality CdxZn1–xS nanocrystals alloy at. 150°C with .... (XRD) using a Siemens model D 500, powder X-ray ... decays were analysed using IBH DAS6 software. 3. ... This alloying process is.

  9. COSMOS--improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial.

    Science.gov (United States)

    Husebo, Bettina S; Flo, Elisabeth; Aarsland, Dag; Selbaek, Geir; Testad, Ingelin; Gulla, Christine; Aasmul, Irene; Ballard, Clive

    2015-09-15

    Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial. COSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality. Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover

  10. Methods and systems for fabricating high quality superconducting tapes

    Science.gov (United States)

    Majkic, Goran; Selvamanickam, Venkat

    2018-02-13

    An MOCVD system fabricates high quality superconductor tapes with variable thicknesses. The MOCVD system can include a gas flow chamber between two parallel channels in a housing. A substrate tape is heated and then passed through the MOCVD housing such that the gas flow is perpendicular to the tape's surface. Precursors are injected into the gas flow for deposition on the substrate tape. In this way, superconductor tapes can be fabricated with variable thicknesses, uniform precursor deposition, and high critical current densities.

  11. Managing quality inside a high-technology project organization

    OpenAIRE

    Jokinen, T. (Tauno)

    2004-01-01

    Abstract This action research addresses the deployment of Total Quality Management (TQM) principles in a high-technology new product development organisation. During the period of study, the organisation grew fast. High-technology product development and hypergrowth provided a unique combination of extreme conditions for the study. The existing concepts of TQM are presented as an organised map enabling strategic analysis for an implementation plan. The history of TQM dates back to the ...

  12. Improvement of quality of reporting in randomised controlled trials to prevent hypotension after spinal anaesthesia for caesarean section

    NARCIS (Netherlands)

    A. Herdan; R. Roth; D. Grass; M. Klimek (Markus); S. Will; B. Schauf; R. Rossaint; M. Heesen

    2011-01-01

    textabstractHypotension is a frequent complication of spinal anaesthesia for caesarean section and can threaten the well-being of the unborn child. Numerous randomised controlled trials (RCTs) dealt with measures to prevent hypotension. The aim of this study was to determine the reporting quality of

  13. A protocol for generating a high-quality genome-scale metabolic reconstruction.

    Science.gov (United States)

    Thiele, Ines; Palsson, Bernhard Ø

    2010-01-01

    Network reconstructions are a common denominator in systems biology. Bottom-up metabolic network reconstructions have been developed over the last 10 years. These reconstructions represent structured knowledge bases that abstract pertinent information on the biochemical transformations taking place within specific target organisms. The conversion of a reconstruction into a mathematical format facilitates a myriad of computational biological studies, including evaluation of network content, hypothesis testing and generation, analysis of phenotypic characteristics and metabolic engineering. To date, genome-scale metabolic reconstructions for more than 30 organisms have been published and this number is expected to increase rapidly. However, these reconstructions differ in quality and coverage that may minimize their predictive potential and use as knowledge bases. Here we present a comprehensive protocol describing each step necessary to build a high-quality genome-scale metabolic reconstruction, as well as the common trials and tribulations. Therefore, this protocol provides a helpful manual for all stages of the reconstruction process.

  14. Clinical trial of telepathology as an alternative modality in breast histopathology quality assurance.

    Science.gov (United States)

    Leong, F J; Graham, A K; Schwarzmann, P; McGee, J O

    2000-01-01

    Telepathology is a potential alternative to conventional histopathology. A clinical trial using a robotic telepathology system was conducted to assess the clinical and technical utility and effectiveness of telepathology in the U.K. breast screening pathology quality assurance program. Eighty-seven cases of breast disease were chosen at random from a series of 192 cases from the U.K. Breast Screening Pathology National Quality Assurance Scheme (NEQAS) collection. There were 20 benign, 23 carcinoma in situ (CIS), and 44 invasive malignant cases. The diagnostic accuracy of telepathology (TP) compared with conventional light microscopic (LM) diagnosis was 98.8%; this included a single case deferred for LM examination. The figure was similar when compared with expert consensus diagnosis (CD). In invasive tumor typing, TP accuracy was 95.4% (42/44 cases), the difference being attributable to slide color fading and would have had no impact on patient management. The accuracy of TP versus LM and expert consensus in tumor grading was 91.3% for carcinoma in situ (21/23 cases), a discordance with no relevance to patient management. TP grading of invasive tumor compared with LM diagnosis, had an accuracy of 86.4% (38/44) with a clinically significant accuracy of 97.7% (43/44). The time taken for TP diagnosis averaged 3.9 minutes per case by the end of the study. This data demonstrates that telepathology diagnostic accuracy is comparable to conventional microscopy and may therefore be envisaged as an alternative to conventional light microscopy for more rapid proficiency testing in breast screening (and perhaps other) quality assurance schemes.

  15. [Quality of sleep and academic performance in high school students].

    Science.gov (United States)

    Bugueño, Maithe; Curihual, Carolina; Olivares, Paulina; Wallace, Josefa; López-AlegrÍa, Fanny; Rivera-López, Gonzalo; Oyanedel, Juan Carlos

    2017-09-01

    Sleeping and studying are the day-to-day activities of a teenager attending school. To determine the quality of sleep and its relationship to the academic performance among students attending morning and afternoon shifts in a public high school. Students of the first and second year of high school answered an interview about socio-demographic background, academic performance, student activities and subjective sleep quality; they were evaluated using the Pittsburgh Sleep Quality Index (PSQI). The interview was answered by 322 first year students aged 15 ± 5 years attending the morning shift and 364 second year students, aged 16 ± 0.5 years, attending the afternoon shift. The components: sleep latency, habitual sleep efficiency, sleep disturbance, drug use and daytime dysfunction were similar and classified as good in both school shifts. The components subjective sleep quality and duration of sleep had higher scores among students of the morning shift. The mean grades during the first semester of the students attending morning and afternoon shifts were 5.9 and 5.8, respectively (of a scale from 1 to 7). Among students of both shifts, the PSQI scale was associated inversely and significantly with academic performance. A bad sleep quality influences academic performance in these students.

  16. Manual therapy for tension-type headache related to quality of work life and work presenteeism: Secondary analysis of a randomized controlled trial.

    Science.gov (United States)

    Monzani, Lucas; Espí-López, Gemma Victoria; Zurriaga, Rosario; Andersen, Lars L

    2016-04-01

    The objective of this research is to evaluate the efficacy of manual therapy for tension-type headache (TTH) in restoring workers quality of work life, and how work presenteeism affects this relation. This study is a secondary analysis of a factorial, randomized clinical trial on manual therapy interventions. Altogether, 80 patients (85% women) with TTH and without current symptoms of any other concomitant disease participated. An experienced therapist delivered the treatment: myofascial inhibitory technique (IT), articulatory technique (AT), combined technique (IT and AT), and control group (no treatment). In general, all treatments as compared to our control group had a large effect (f≥.69) in the improvement of participants' quality of work life. Work presenteeism interacted with TTH treatment type's efficacy on participant's quality of work life. The inhibitory technique lead to higher reports of quality of work life than other treatment options only for participants with very low frequency of work presenteeism. In turn, TTH articulatory treatment techniques resulted in higher reports of quality of work life for a high to very high work presenteeism frequency. Articulatory manipulation technique is the more efficient treatment to improve quality of work life when the frequency of work presenteeism is high. Implications for future research and practice are discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Highly qualified does not equal high quality: A study of urban stakeholders' perceptions of quality in science teaching

    Science.gov (United States)

    Miranda, Rommel Joseph

    By employing qualitative methods, this study sought to determine the perceptions that urban stakeholders hold about what characteristics should distinguish a high school science teacher whom they would consider to demonstrate high quality in science teaching. A maximum variation sample of six science teachers, three school administrators, six parents and six students from a large urban public school district were interviewed using semi-structured, in-depth interview techniques. From these data, a list of observable characteristics which urban stakeholders hold as evidence of high quality in science teaching was generated. Observational techniques were utilized to determine the extent to which six urban high school science teachers, who meet the NCLB Act criteria for being "highly qualified", actually possessed the characteristics which these stakeholders hold as evidence of high quality in science teaching. Constant comparative analysis was used to analyze the data set. The findings suggest that urban stakeholders perceive that a high school science teacher who demonstrates high quality in science teaching should be knowledgeable about their subject matter, their student population, and should be resourceful; should possess an academic background in science and professional experience in science teaching; should exhibit professionalism, a passion for science and teaching, and a dedication to teaching and student learning; should be skillful in planning and preparing science lessons and in organizing the classroom, in presenting the subject matter to students, in conducting a variety of hands-on activities, and in managing a classroom; and should assess whether students complete class goals and objectives, and provide feedback about grades for students promptly. The findings further reveal that some of the urban high school science teachers who were deemed to be "highly qualified", as defined by the NCLB Act, engaged in practices that threatened quality in science

  18. High quality digital holographic reconstruction on analog film

    Science.gov (United States)

    Nelsen, B.; Hartmann, P.

    2017-05-01

    High quality real-time digital holographic reconstruction, i.e. at 30 Hz frame rates, has been at the forefront of research and has been hailed as the holy grail of display systems. While these efforts have produced a fascinating array of computer algorithms and technology, many applications of reconstructing high quality digital holograms do not require such high frame rates. In fact, applications such as 3D holographic lithography even require a stationary mask. Typical devices used for digital hologram reconstruction are based on spatial-light-modulator technology and this technology is great for reconstructing arbitrary holograms on the fly; however, it lacks the high spatial resolution achievable by its analog counterpart, holographic film. Analog holographic film is therefore the method of choice for reconstructing highquality static holograms. The challenge lies in taking a static, high-quality digitally calculated hologram and effectively writing it to holographic film. We have developed a theoretical system based on a tunable phase plate, an intensity adjustable high-coherence laser and a slip-stick based piezo rotation stage to effectively produce a digitally calculated hologram on analog film. The configuration reproduces the individual components, both the amplitude and phase, of the hologram in the Fourier domain. These Fourier components are then individually written on the holographic film after interfering with a reference beam. The system is analogous to writing angularly multiplexed plane waves with individual component phase control.

  19. Long quantum channels for high-quality entanglement transfer

    International Nuclear Information System (INIS)

    Banchi, L; Apollaro, T J G; Cuccoli, A; Verrucchi, P; Vaia, R

    2011-01-01

    High-quality quantum-state and entanglement transfer can be achieved in an unmodulated spin bus operating in the ballistic regime, which occurs when the endpoint qubits A and B are nonperturbatively coupled to the chain by a suitable exchange interaction j 0 . Indeed, the transition amplitude characterizing the transfer quality exhibits a maximum for a finite optimal value j opt 0 (N), where N is the channel length. We show that j opt 0 (N) scales as N -1/6 for large N and that it ensures a high-quality entanglement transfer even in the limit of arbitrarily long channels, almost independently of the channel initialization. For instance, for any chain length the average quantum-state transmission fidelity exceeds 90% and decreases very little in a broad neighbourhood of j opt 0 (N). We emphasize that, taking the reverse point of view, should j 0 be experimentally constrained, high-quality transfer can still be obtained by adjusting the channel length to its optimal value. (paper)

  20. Integration study of high quality teaching resources in universities

    Directory of Open Access Journals (Sweden)

    Honglu Liu

    2012-12-01

    Full Text Available Purpose: The development level and quality of education depend on the merits and efficiency in the use of teaching resources, especially in the case of obvious contradiction between the demand and supply of teaching resources. So to integrate teaching resources, improve the efficiency in the use of high quality teaching resources, and take the road of content development to enhance the competitiveness of education has become very important and urgent.Design/methodology/approach: On the basis of analysis on the teaching resources of universities and the problems they faced, this paper introduced the basic concepts of cloud storage, and built the integration architecture of high quality teaching resources in universities based on the cloud storage.Findings and Originality/value: The HDFS-based cloud storage proposed in this paper is a dynamically adjustable and Internet-based storage solution, and the users can access storage targets using the network through a common and easy-to-use protocol and application programming interfaces. This new technology is useful for end users benefits. With the continuous development and improvement of cloud storage, it will necessarily result in more and more applications in the institutions of higher learning and education network.Originality/value: This paper introduced the cloud storage into the integration of high quality teaching resources in universities first and as a new form of service, it can be a good solution.

  1. Target for improvement: a cluster randomised trial of public involvement in quality-indicator prioritisation (intervention development and study protocol

    Directory of Open Access Journals (Sweden)

    Burgers Jako

    2011-05-01

    Full Text Available Abstract Background Public priorities for improvement often differ from those of clinicians and managers. Public involvement has been proposed as a way to bridge the gap between professional and public clinical care priorities but has not been studied in the context of quality-indicator choice. Our objective is to assess the feasibility and impact of public involvement on quality-indicator choice and agreement with public priorities. Methods We will conduct a cluster randomised controlled trial comparing quality-indicator prioritisation with and without public involvement. In preparation for the trial, we developed a 'menu' of quality indicators, based on a systematic review of existing validated indicator sets. Participants (public representatives, clinicians, and managers will be recruited from six participating sites. In intervention sites, public representatives will be involved through direct participation (public representatives, clinicians, and managers will deliberate together to agree on quality-indicator choice and use and consultation (individual public recommendations for improvement will be collected and presented to decision makers. In control sites, only clinicians and managers will take part in the prioritisation process. Data on quality-indicator choice and intended use will be collected. Our primary outcome will compare quality-indicator choice and agreement with public priorities between intervention and control groups. A process evaluation based on direct observation, videorecording, and participants' assessment will be conducted to help explain the study's results. The marginal cost of public involvement will also be assessed. Discussion We identified 801 quality indicators that met our inclusion criteria. An expert panel agreed on a final set of 37 items containing validated quality indicators relevant for chronic disease prevention and management in primary care. We pilot tested our public-involvement intervention with 27

  2. Examination of Operation Quality for High-frequent Railway Operation

    DEFF Research Database (Denmark)

    Landex, Alex; Kaas, Anders H.

    2009-01-01

    take the first train in their direction. The article examines four different approaches to examine operation quality for high-frequent operation that are based on the experiences of the passengers. These approaches are the service frequency of the operation, travel time extension, a combination......The examination of operation quality for high-frequent operation requires other approaches than the typical evaluation of punctuality (trains on time) and reliability (operated trains). This is because passengers in high-frequent railway systems do not necessarily notice train delays as they just...... of the service frequency and travel time approaches, and passenger delays. The service frequency and travel time approaches are simple measurements with low complexity and complement each other. Therefore, the article recommends combining the service frequency and travel time approaches to get a more accurate...

  3. A randomized controlled trial of an educational video to improve quality of bowel preparation for colonoscopy.

    Science.gov (United States)

    Park, Jin-Seok; Kim, Min Su; Kim, HyungKil; Kim, Shin Il; Shin, Chun Ho; Lee, Hyun Jung; Lee, Won Seop; Moon, Soyoung

    2016-06-17

    High-quality bowel preparation is necessary for colonoscopy. A few studies have been conducted to investigate improvement in bowel preparation quality through patient education. However, the effect of patient education on bowel preparation has not been well studied. A randomized and prospective study was conducted. All patients received regular instruction for bowel preparation during a pre-colonoscopy visit. Those scheduled for colonoscopy were randomly assigned to view an educational video instruction (video group) on the day before the colonoscopy, or to a non-video (control) group. Qualities of bowel preparation using the Ottawa Bowel Preparation Quality scale (Ottawa score) were compared between the video and non-video groups. In addition, factors associated with poor bowel preparation were investigated. A total of 502 patients were randomized, 250 to the video group and 252 to the non-video group. The video group exhibited better bowel preparation (mean Ottawa total score: 3.03 ± 1.9) than the non-video group (4.21 ± 1.9; P educational video could improve the quality of bowel preparation in comparison with standard preparation method. Clinical Research Information Service KCT0001836 . The date of registration: March, 08(th), 2016, Retrospectively registered.

  4. Sleep Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

    Science.gov (United States)

    2016-10-01

    Cognition, Quality of Life, and Cardiovascular Disease PRINCIPAL INVESTIGATOR: Shirin Shafazand, MD, MS CONTRACTING ORGANIZATION: University of Miami...with positive airway pressure (PAP) will improve cognitive impairment, sleep quality, quality of life, and cardiovascular disease (CVD) surrogate...Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease Shirin Shafazand, MD, MS Nothing listed 12

  5. Electronic symptom reporting between patient and provider for improved health care service quality: a systematic review of randomized controlled trials. part 2: methodological quality and effects.

    Science.gov (United States)

    Johansen, Monika Alise; Berntsen, Gro K Rosvold; Schuster, Tibor; Henriksen, Eva; Horsch, Alexander

    2012-10-03

    We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy. To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies. We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions. Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12

  6. Quality and efficiency in high dimensional Nearest neighbor search

    KAUST Repository

    Tao, Yufei; Yi, Ke; Sheng, Cheng; Kalnis, Panos

    2009-01-01

    Nearest neighbor (NN) search in high dimensional space is an important problem in many applications. Ideally, a practical solution (i) should be implementable in a relational database, and (ii) its query cost should grow sub-linearly with the dataset size, regardless of the data and query distributions. Despite the bulk of NN literature, no solution fulfills both requirements, except locality sensitive hashing (LSH). The existing LSH implementations are either rigorous or adhoc. Rigorous-LSH ensures good quality of query results, but requires expensive space and query cost. Although adhoc-LSH is more efficient, it abandons quality control, i.e., the neighbor it outputs can be arbitrarily bad. As a result, currently no method is able to ensure both quality and efficiency simultaneously in practice. Motivated by this, we propose a new access method called the locality sensitive B-tree (LSB-tree) that enables fast highdimensional NN search with excellent quality. The combination of several LSB-trees leads to a structure called the LSB-forest that ensures the same result quality as rigorous-LSH, but reduces its space and query cost dramatically. The LSB-forest also outperforms adhoc-LSH, even though the latter has no quality guarantee. Besides its appealing theoretical properties, the LSB-tree itself also serves as an effective index that consumes linear space, and supports efficient updates. Our extensive experiments confirm that the LSB-tree is faster than (i) the state of the art of exact NN search by two orders of magnitude, and (ii) the best (linear-space) method of approximate retrieval by an order of magnitude, and at the same time, returns neighbors with much better quality. © 2009 ACM.

  7. High quality flux control system for electron gun evaporation

    International Nuclear Information System (INIS)

    Appelbloom, A.M.; Hadley, P.; van der Marel, D.; Mooij, J.E.

    1991-01-01

    This paper reports on a high quality flux control system for electron gun evaporation developed and tested for the MBE growth of high temperature superconductors. The system can be applied to any electron gun without altering the electron gun itself. Essential elements of the system are a high bandwidth mass spectrometer, control electronics and a high voltage modulator to sweep the electron beam over the melt at high frequencies. the sweep amplitude of the electron beam is used to control the evaporation flux at high frequencies. The feedback loop of the system has a bandwidth of over 100 Hz, which makes it possible to grow superlattices and layered structures in a fast and precisely controlled manner

  8. CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial.

    Science.gov (United States)

    Mendelson, Monique; Vivodtzev, Isabelle; Tamisier, Renaud; Laplaud, David; Dias-Domingos, Sonia; Baguet, Jean-Philippe; Moreau, Laurent; Koltes, Christian; Chavez, Léonidas; De Lamberterie, Gilles; Herengt, Frédéric; Levy, Patrick; Flore, Patrice; Pépin, Jean-Louis

    2014-11-01

    Obstructive sleep apnea (OSA) has been associated with hypertension, which is one of the intermediary mechanisms leading to increased cardiovascular morbidity. This study aimed at evaluating the effects of a combination of continuous positive airway pressure (CPAP) and telemedicine support on blood pressure (BP) reduction in high cardiovascular risk OSA patients. A multi-center randomized controlled trial that compared standard CPAP care and CPAP care and a telemedicine intervention. Sleep clinics in France. 107 adult (18-65 years old) OSA patients (AHI > 15 events/h) with a high cardiovascular risk (cardiovascular SCORE > 5% or secondary prevention). Patients were randomized to either standard care CPAP (n = 53) or CPAP and telemedicine (n = 54). Patients assigned to telemedicine were equipped with a smartphone for uploading BP measurements, CPAP adherence, sleepiness, and quality of life data; in return, they received pictograms containing health-related messages. The main outcome was home self-measured BP and secondary outcomes were cardiovascular risk evolution, objective physical activity, CPAP adherence, sleepiness and quality of life. Self-measured BP did not improve in either group (telemedicine or standard care). Patients in primary prevention showed greater BP reduction with CPAP treatment than those in secondary prevention. CPAP treatment supported by telemedicine alone did not improve blood pressure and cardiovascular risk in high cardiovascular risk OSA patients. This study emphasizes the need for diet and physical activity training programs in addition to CPAP when aiming at decreasing cardiometabolic risk factors in these patients. ClinicalTrials.gov identifier: NCT01226641.

  9. Evaluation of the quality of the reporting of phase II clinical trials in oncology: A systematic review.

    Science.gov (United States)

    Rivoirard, Romain; Langrand-Escure, Julien; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Rancoule, Chloé; Magné, Nicolas; Bourmaud, Aurélie

    2018-05-01

    To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles. The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies. Copyright © 2018 Elsevier B.V. All rights reserved.

  10. Long-term quality of life in patients with rectal cancer treated with preoperative (chemo)-radiotherapy within a randomized trial

    International Nuclear Information System (INIS)

    Tiv, M.; Puyraveau, M.; Mercier, M.; Bosset, J.F.; Puyraveau, M.; Mineur, L.; Calais, G.; Maingon, P.; Bardet, E.; Mercier, M.; Bosset, J.F.

    2010-01-01

    Purpose: Few studies have evaluated the quality of life (QoL) of patients with rectal cancer. This report describes the quality of life of French patients who entered the 22921 EORTC trial that investigated the role and place of chemotherapy (CT) added to preoperative radiotherapy (preop-RT). Patients and Methods: Patients without recurrences were evaluated with EORTC QLQ-C30 and QLQ-CR38 questionnaires, after a median time of 4.6 years from randomization. Results: All the scores of QLQ-C30 functions were high, from 78 up to 88, with those of global health quality of life scale (GHQL) status being 73. The mean scores of symptoms were low except for diarrhea. For QLQ-CR38, the mean scores for 'body image' and 'future perspective' were high at 79.6 and 69.7 respectively. The scores for 'sexual functioning' and 'enjoyment' were low. Men had more sexual problems than females (62.5 vs 25 mean scores respectively). Chemotherapy was associated with more diarrhea complaints, lower 'role', lower 'social functioning' and lower global health quality of life scale. Conclusion: The overall quality of life of patients with rectal cancer is quite good 4.6 years after the beginning preoperative treatments. However, adding chemotherapy to preoperative radiotherapy has a negative effect on diarrhea complaints and some quality of life dimensions. (authors)

  11. Safety and quality management at the high flux reactor Petten

    International Nuclear Information System (INIS)

    Zurita, A.; Ahlf, J.

    1995-01-01

    The High Flux Reactor (HFR) is one high power multi-purpose materials testing research reactor of the tank-in-pool type, cooled and moderated by light-water. It is operated at 45 MW at a prescribed schedule of 11 cycles per year, each comprising 25 operation days and three shut-down days. Since the licence for the operation of HFR was granted in 1962, a total of 14 amendments to the original licence have been made following different modifications in the installations. In the meantime, international nuclear standards were developed, especially in the framework of the NUSS programme of the IAEA, which were adopted by the Dutch Licensing Authorities. In order to implement the new standards, the situation at the HFR was comprehensively reviewed in the course of an audit performed by the Dutch Licensing Authorities in 1988. This also resulted in formulating the task of setting-up an 'HFR - Integral Quality Assurance Handbook' (HFR-IQAD) involving both organizations JRCIAM and ECN, which had the unique framework and basic guideline to assure the safe and efficient operation and exploitation of the HFR and to promote safety and quality in all aspects of HFR related activities. The assurance of safe and efficient operation and exploitation of the HFR is condensed together under the concepts of safety and quality of services and is achieved through the safety and quality management. (orig.)

  12. Evaluating quality of life and cost implications of prophylactic radiotherapy in mesothelioma: Health economic analysis of the SMART trial.

    Science.gov (United States)

    Stewart, Samuel Alan; Clive, Amelia O; Maskell, Nick A; Penz, Erika

    2018-01-01

    The SMART trial is a UK-based, multicentre RCT comparing prophylactic radiotherapy and symptom-based (deferred) radiotherapy in 203 patients with Malignant Pleural Mesothelioma who had undergone large bore pleural interventions. Using costs and quality of life data collected alongside the clinical trial, we will estimate the cost-effectiveness of prophylactic radiotherapy compared to deferred radiotherapy over a 1-year period. Healthcare utilization and costs were captured during the trial. Utility weights produced by the EQ-5D questionnaire were used to determine quality-adjusted life-years (QALY) gained. The incremental cost-effectiveness ratio was calculated over the one-year trial period. Costs were similar in the immediate and deferred radiotherapy groups: £5480.40 (SD = £7040; n = 102) and £5461.40 (SD = £7770; n = 101) respectively. There was also no difference in QALY: 0.498 (95% CI: [0.45, 0.547]) in the prophylactic radiotherapy group versus 0.525 (95% CI: [0.471, 0.580]) in the deferred group. At a willingness to pay threshold of £30,000/QALY there was only a 24% chance that prophylactic radiotherapy was cost-effective compared to deferred radiotherapy. There was no significant effect of prophylactic radiotherapy on quality of life in the intervention group, nor was there any discernable decrease in healthcare costs. There is little evidence to suggest that prophylactic radiotherapy is a cost-effective intervention in this population. ISRCTN72767336 with ISRCTN.

  13. The effect of technology-based interventions on pain, depression, and quality of life in patients with cancer: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Agboola, Stephen O; Ju, Woong; Elfiky, Aymen; Kvedar, Joseph C; Jethwani, Kamal

    2015-03-13

    concealment domain. Two of the three studies focused on pain control reported significant effects of the intervention; four of the nine studies focus on depression reported significant effects, while only the studies that were focused on quality of life reported significant effects. This systematic review demonstrates the potential of telehealth interventions in improving outcomes in cancer care. However, more high-quality large-sized trials are needed to demonstrate cogent evidence of its effectiveness.

  14. Improving the quality of colonoscopy bowel preparation using a smart phone application: a randomized trial.

    Science.gov (United States)

    Lorenzo-Zúñiga, Vicente; Moreno de Vega, Vicente; Marín, Ingrid; Barberá, Marta; Boix, Jaume

    2015-07-01

    Getting ready for a colonoscopy is difficult and involves many steps. Information given to patients is very important for adherence to treatment. We created a novel smart phone application (SPA) aimed to increase bowel preparation quality and patient satisfaction. We carried out a prospective, endoscopist-blinded, randomized, controlled trial. We enrolled 260 outpatient (58% female, age range 21-75 years) owners of a smartphone. Patients were allocated to two different protocols: instructions provided by SPA (SPA group; n = 108) or written instructions with visual aids (control group; n = 152). All procedures were carried out in the afternoon and patients received the same purgative regimen (2 L polyethylene glycol (PEG) solution plus ascorbic acid), in a full-dose same-day regimen. The study was designed to detect an improvement in quality of bowel preparation using the Harefield Cleansing Scale (HCS) scale. Effect of protocol on patient satisfaction was assessed with a specific questionnaire at the time of colonoscopy. Proportion of patients who obtained successful bowel preparation for colonoscopy (HCS A or B) was significantly higher in the SPA group than in the control group (100% vs 96.1%, respectively; P = 0.037). Mean global HCS scores were similar in both groups. Patient-reported tolerability and overall experience with the prescribed bowel preparation were significantly higher for the SPA group than for the control group. Successful cleansing and patient acceptability with the use of SPA were superior to written instructions in outpatients submitted for colonoscopy using 2 L PEG solution plus ascorbic acid. © 2015 The Authors. Digestive Endoscopy © 2015 Japan Gastroenterological Endoscopy Society.

  15. Wellbeing Understanding in High Quality Healthcare Informatics and Telepractice.

    Science.gov (United States)

    Fiorini, Rodolfo A; De Giacomo, Piero; L'Abate, Luciano

    2016-01-01

    The proper use of healthcare informatics technology and multidimensional conceptual clarity are fundamental to create and boost outstanding clinical and telepractice results. Avoiding even terminology ambiguities is mandatory for high quality of care service. For instance, well-being or wellbeing is a different way to write the same concept only, or there is a good deal of ambiguity around the meanings of these terms the way they are written. In personal health, healthcare and healthcare informatics, this kind of ambiguity and lack of conceptual clarity has been called out repeatedly over the past 50 years. It is time to get the right, terse scenario. We present a brief review to develop and achieve ultimate wellbeing understanding for practical high quality healthcare informatics and telepractice application. This article presents an innovative point of view on deeper wellbeing understanding towards its increased clinical effective application.

  16. Oral health related quality of life among pregnant women: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marta Liliana Musskopf

    2018-01-01

    Full Text Available Abstract: The aim of the present study was to compare negative impacts of oral conditions in Oral Heath Related Quality of Life (OHRQoL assessed by the Oral Health Impact Profile-14 (OHIP-14 scores in pregnant women receiving or not comprehensive periodontal treatment. This randomized controlled clinical trial included pregnant women aged between 18 and 35 years old. Participants were randomized in a test group with 96 and a control group with 114 women. Patients in the test group received comprehensive periodontal treatment, supra and subgingival scaling and root-planning and periodontal maintenance appointments. The OHIP-14 was applied before and after treatment. The primary outcome was changes in OHIP-14 scores after follow-up period. The impact of having received or not comprehensive periodontal treatment on the change of the OHIP-14 scores was also investigated. Both groups showed significant reduction in OHIP-14 scores and effect size for the test group was 0.60 and 0.36 for the control group. Multinomial logistic regression analysis showed that participants of the control group had 5.9-fold odds (CI 95% 1.88-18.52 of worsening in OHIP-14 scores and their perception of oral conditions in relation to test group. Comprehensive periodontal treatment during pregnancy can reduce the negative impacts in OHRQoL.

  17. Quality assurance system for sitting high risk facilities

    International Nuclear Information System (INIS)

    Rodriguez, Aymee; Peralta, Jose L.; Fernandez, Manuel

    1999-01-01

    The paper shows how we have conceived and designed the quality assurance system for the site selection process of an area for sitting the facility of high risk in correspondence with the approved methodology. The results obtained in the implementation of the system have permitted the satisfactory performance of each one the expected stage, defining the most favorable sectors in order to continue the studies of the repository site for the disposal of low and intermedium. (author)

  18. High-quality uniform dry transfer of graphene to polymers.

    Science.gov (United States)

    Lock, Evgeniya H; Baraket, Mira; Laskoski, Matthew; Mulvaney, Shawn P; Lee, Woo K; Sheehan, Paul E; Hines, Daniel R; Robinson, Jeremy T; Tosado, Jacob; Fuhrer, Michael S; Hernández, Sandra C; Walton, Scott G

    2012-01-11

    In this paper we demonstrate high-quality, uniform dry transfer of graphene grown by chemical vapor deposition on copper foil to polystyrene. The dry transfer exploits an azide linker molecule to establish a covalent bond to graphene and to generate greater graphene-polymer adhesion compared to that of the graphene-metal foil. Thus, this transfer approach provides a novel alternative route for graphene transfer, which allows for the metal foils to be reused. © 2011 American Chemical Society

  19. Coupling of high-quality-factor optical resonators

    International Nuclear Information System (INIS)

    Salzenstein, Patrice; Henriet, Rémi; Coillet, Aurélien; Chembo, Yanne K; Mortier, Michel; Sérier-Brault, Hélène; Rasoloniaina, Alphonse; Dumeige, Yannick; Féron, Patrice

    2013-01-01

    We improve theoretically and experimentally the problem of the coupling between a high Q-factor resonator and its external coupler. We have observed oscillations of ringing induced by the sweeping of the excitation frequency of an active microsphere. Thanks to this approach, the quality factor of an optical resonator was measured and we obtained Q = 5.8 × 10 8 . (paper)

  20. Effects of Rosmarinus officinalis L. on memory performance, anxiety, depression, and sleep quality in university students: A randomized clinical trial.

    Science.gov (United States)

    Nematolahi, Pouya; Mehrabani, Mitra; Karami-Mohajeri, Somayyeh; Dabaghzadeh, Fatemeh

    2018-02-01

    To evaluate the effects of oral rosemary on memory performance, anxiety, depression, and sleep quality in university students. In this double-blinded randomized controlled trial, the 68 participating students randomly received 500 mg rosemary and placebo twice daily for one month. Prospective and retrospective memory performance, depression, anxiety and sleep quality of the students were measured using Prospective and Retrospective Memory Questionnaire, Hospital Anxiety and Depression Scale, and Pittsburgh Sleep Quality Inventory at baseline and after one month. The scores of all the scales and subscales except the sleep latency and sleep duration components of Pittsburgh Sleep Quality Inventory were significantly decreased in the rosemary group in comparison with the control group after one month. Rosemary as a traditional herb could be used to boost prospective and retrospective memory, reduce anxiety and depression, and improve sleep quality in university students. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. A high throughput DNA extraction method with high yield and quality

    Directory of Open Access Journals (Sweden)

    Xin Zhanguo

    2012-07-01

    Full Text Available Abstract Background Preparation of large quantity and high quality genomic DNA from a large number of plant samples is a major bottleneck for most genetic and genomic analyses, such as, genetic mapping, TILLING (Targeting Induced Local Lesion IN Genome, and next-generation sequencing directly from sheared genomic DNA. A variety of DNA preparation methods and commercial kits are available. However, they are either low throughput, low yield, or costly. Here, we describe a method for high throughput genomic DNA isolation from sorghum [Sorghum bicolor (L. Moench] leaves and dry seeds with high yield, high quality, and affordable cost. Results We developed a high throughput DNA isolation method by combining a high yield CTAB extraction method with an improved cleanup procedure based on MagAttract kit. The method yielded large quantity and high quality DNA from both lyophilized sorghum leaves and dry seeds. The DNA yield was improved by nearly 30 fold with 4 times less consumption of MagAttract beads. The method can also be used in other plant species, including cotton leaves and pine needles. Conclusion A high throughput system for DNA extraction from sorghum leaves and seeds was developed and validated. The main advantages of the method are low cost, high yield, high quality, and high throughput. One person can process two 96-well plates in a working day at a cost of $0.10 per sample of magnetic beads plus other consumables that other methods will also need.

  2. Methods and systems for fabricating high quality superconducting tapes

    Energy Technology Data Exchange (ETDEWEB)

    Majkic, Goran; Selvamanickam, Venkat

    2018-02-13

    An MOCVD system fabricates high quality superconductor tapes with variable thicknesses. The MOCVD system can include a gas flow chamber between two parallel channels in a housing. A substrate tape is heated and then passed through the MOCVD housing such that the gas flow is perpendicular to the tape's surface. Precursors are injected into the gas flow for deposition on the substrate tape. In this way, superconductor tapes can be fabricated with variable thicknesses, uniform precursor deposition, and high critical current densities.

  3. High quality mask storage in an advanced Logic-Fab

    Science.gov (United States)

    Jähnert, Carmen; Fritsche, Silvio

    2012-02-01

    High efficient mask logistics as well as safe and high quality mask storage are essential requirements within an advanced lithography area of a modern logic waferfab. Fast operational availability of the required masks at the exposure tool with excellent mask condition requires a safe mask handling, safeguarding of high mask quality over the whole mask usage time without any quality degradation and an intelligent mask logistics. One big challenge is the prevention of haze on high advanced phase shift masks used in a high volume production line for some thousands of 248nm or 193nm exposures. In 2008 Infineon Dresden qualified a customer specific developed semi-bare mask storage system from DMSDynamic Micro Systems in combination with a high advanced mask handling and an interconnected complex logistic system. This high-capacity mask storage system DMS M1900.22 for more than 3000 masks with fully automated mask and box handling as well as full-blown XCDA purge has been developed and adapted to the Infineon Lithotoollandscape using Nikon and SMIF reticle cases. Advanced features for ESD safety and mask security, mask tracking via RFID and interactions with the exposure tools were developed and implemented. The stocker is remote controlled by the iCADA-RSM system, ordering of the requested mask directly from the affected exposure tool allows fast access. This paper discusses the advantages and challenges for this approach as well as the practical experience gained during the implementation of the new system which improves the fab performance with respect to mask quality, security and throughput. Especially the realization of an extremely low and stable humidity level in addition with a well controlled air flow at each mask surface, preventing masks from haze degradation and particle contamination, turns out to be a notable technical achievement. The longterm stability of haze critical masks has been improved significantly. Relevant environmental parameters like

  4. Provision of medical supply kits to improve quality of antenatal care in Mozambique: a stepped-wedge cluster randomised trial.

    Science.gov (United States)

    Betrán, Ana Pilar; Bergel, Eduardo; Griffin, Sally; Melo, Armando; Nguyen, My Huong; Carbonell, Alicia; Mondlane, Santos; Merialdi, Mario; Temmerman, Marleen; Gülmezoglu, A Metin

    2018-01-01

    High levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99

  5. Quality Assurance and Improvement in Head and Neck Cancer Surgery: From Clinical Trials to National Healthcare Initiatives.

    Science.gov (United States)

    Simon, Christian; Caballero, Carmela

    2018-05-24

    It is without question in the best interest of our patients, if we can identify ways to improve the quality of care we deliver to them. Great progress has been made within the last 25 years in terms of development and implementation of quality-assurance (QA) platforms and quality improvement programs for surgery in general, and within this context for head and neck surgery. As of now, we have successfully identified process indicators that impact outcome of our patients and the quality of care we deliver as surgeons. We have developed risk calculators to determine the risk for complications of individual surgical patients. We have created perioperative guidelines for complex head and neck procedures. We have in Europe and North America created audit registries that can gather and analyze data from institutions across the world to better understand which processes need change to obtain good outcomes and improve quality of care. QA platforms can be tested within the clearly defined environment of prospective clinical trials. If positive, such programs could be rolled out within national healthcare systems, if feasible. Testing quality programs in clinical trials could be a versatile tool to help head neck cancer patients benefit directly from such initiatives on a global level.

  6. Improved plan quality with automated radiotherapy planning for whole brain with hippocampus sparing: a comparison to the RTOG 0933 trial.

    Science.gov (United States)

    Krayenbuehl, J; Di Martino, M; Guckenberger, M; Andratschke, N

    2017-10-02

    Whole-brain radiation therapy (WBRT) with hippocampus sparing (HS) has been investigated by the radiation oncology working group (RTOG) 0933 trial for patients with multiple brain metastases. They showed a decrease of adverse neurocognitive effects with HS WBRT compared to WBRT alone. With the development of automated treatment planning system (aTPS) in the last years, a standardization of the plan quality at a high level was achieved. The goal of this study was to evaluate the feasibility of using an aTPS for the treatment of HS WBRT and see if the RTOG 0933 dose constraints could be achieved and improved. Ten consecutive patients treated with HS WBRT were enrolled in this study. 10 × 3 Gy was prescribed according to the RTOG 0933 protocol to 92% of the target volume (whole-brain excluding the hippocampus expanded by 5 mm in 3-dimensions). In contrast to RTOG 0933, the maximum allowed point dose to normal brain was significantly lowered and restricted to 36.5 Gy. All patients were planned with volumetric modulated arc therapy (VMAT) technique using four arcs. Plans were optimized using Auto-Planning (AP) (Philips Radiation Oncology Systems) with one single AP template and optimization. All the constraints from the RTOG 0933 trial were achieved. A significant improvement for the maximal dose to 2% of the brain with a reduction of 4 Gy was achieved (33.5 Gy vs. RTOG 37.5 Gy) and the minimum hippocampus dose was reduced by 10% (8.1 Gy vs. RTOG 9 Gy). A steep dose gradient around the hippocampus was achieved with a mean dose of 27.3 Gy at a distance between 0.5 cm and 1 cm from the hippocampus. The effective working time to optimize a plan was kept below 6'. Automated treatment planning for HS WBRT was able to fulfil all the recommendations from the RTOG 0933 study while significantly improving dose homogeneity and decreasing unnecessary hot spot in the normal brain. With this approach, a standardization of plan quality was achieved and the effective

  7. Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial

    NARCIS (Netherlands)

    Koeneman, M. M.; Kruse, Arnold-Jan; Kooreman, L. F. S.; zur Hausen, Axel; Hopman, Anton H N; Sep, S. J. S.; Van Gorp, T.; Slangen, B. F. M.; van Beekhuizen, H. J.; de Sande, Michiel A. J. van; Gerestein, Cornelis G.; Nijman, H. W.; Kruitwagen, R. F. M. P.

    2017-01-01

    The "TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia" (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia

  8. Construction of High-Quality Camel Immune Antibody Libraries.

    Science.gov (United States)

    Romão, Ema; Poignavent, Vianney; Vincke, Cécile; Ritzenthaler, Christophe; Muyldermans, Serge; Monsion, Baptiste

    2018-01-01

    Single-domain antibodies libraries of heavy-chain only immunoglobulins from camelids or shark are enriched for high-affinity antigen-specific binders by a short in vivo immunization. Thus, potent binders are readily retrieved from relatively small-sized libraries of 10 7 -10 8 individual transformants, mostly after phage display and panning on a purified target. However, the remaining drawback of this strategy arises from the need to generate a dedicated library, for nearly every envisaged target. Therefore, all the procedures that shorten and facilitate the construction of an immune library of best possible quality are definitely a step forward. In this chapter, we provide the protocol to generate a high-quality immune VHH library using the Golden Gate Cloning strategy employing an adapted phage display vector where a lethal ccdB gene has to be substituted by the VHH gene. With this procedure, the construction of the library can be shortened to less than a week starting from bleeding the animal. Our libraries exceed 10 8 individual transformants and close to 100% of the clones harbor a phage display vector having an insert with the length of a VHH gene. These libraries are also more economic to make than previous standard approaches using classical restriction enzymes and ligations. The quality of the Nanobodies that are retrieved from immune libraries obtained by Golden Gate Cloning is identical to those from immune libraries made according to the classical procedure.

  9. Using the web for recruitment, screen, tracking, data management, and quality control in a dietary assessment clinical validation trial.

    Science.gov (United States)

    Arab, Lenore; Hahn, Harry; Henry, Judith; Chacko, Sara; Winter, Ashley; Cambou, Mary C

    2010-03-01

    Screening and tracking subjects and data management in clinical trials require significant investments in manpower that can be reduced through the use of web-based systems. To support a validation trial of various dietary assessment tools that required multiple clinic visits and eight repeats of online assessments, we developed an interactive web-based system to automate all levels of management of a biomarker-based clinical trial. The "Energetics System" was developed to support 1) the work of the study coordinator in recruiting, screening and tracking subject flow, 2) the need of the principal investigator to review study progress, and 3) continuous data analysis. The system was designed to automate web-based self-screening into the trial. It supported scheduling tasks and triggered tailored messaging for late and non-responders. For the investigators, it provided real-time status overviews on all subjects, created electronic case reports, supported data queries and prepared analytic data files. Encryption and multi-level password protection were used to insure data privacy. The system was programmed iteratively and required six months of a web programmer's time along with active team engagement. In this study the enhancement in speed and efficiency of recruitment and quality of data collection as a result of this system outweighed the initial investment. Web-based systems have the potential to streamline the process of recruitment and day-to-day management of clinical trials in addition to improving efficiency and quality. Because of their added value they should be considered for trials of moderate size or complexity. Copyright 2009 Elsevier Inc. All rights reserved.

  10. The quality of the reported sample size calculations in randomized controlled trials indexed in PubMed.

    Science.gov (United States)

    Lee, Paul H; Tse, Andy C Y

    2017-05-01

    There are limited data on the quality of reporting of information essential for replication of the calculation as well as the accuracy of the sample size calculation. We examine the current quality of reporting of the sample size calculation in randomized controlled trials (RCTs) published in PubMed and to examine the variation in reporting across study design, study characteristics, and journal impact factor. We also reviewed the targeted sample size reported in trial registries. We reviewed and analyzed all RCTs published in December 2014 with journals indexed in PubMed. The 2014 Impact Factors for the journals were used as proxies for their quality. Of the 451 analyzed papers, 58.1% reported an a priori sample size calculation. Nearly all papers provided the level of significance (97.7%) and desired power (96.6%), and most of the papers reported the minimum clinically important effect size (73.3%). The median (inter-quartile range) of the percentage difference of the reported and calculated sample size calculation was 0.0% (IQR -4.6%;3.0%). The accuracy of the reported sample size was better for studies published in journals that endorsed the CONSORT statement and journals with an impact factor. A total of 98 papers had provided targeted sample size on trial registries and about two-third of these papers (n=62) reported sample size calculation, but only 25 (40.3%) had no discrepancy with the reported number in the trial registries. The reporting of the sample size calculation in RCTs published in PubMed-indexed journals and trial registries were poor. The CONSORT statement should be more widely endorsed. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  11. The health-related quality of life was not improved by targeting higher hemoglobin in the Normal Hematocrit Trial.

    Science.gov (United States)

    Coyne, Daniel W

    2012-07-01

    The Normal Hematocrit Trial (NHT) was the largest trial of epoetin randomizing 1265 hemodialysis patients with cardiac disease to lower (9-11 g/dl) or higher (13-15 g/dl) hemoglobin (Hgb), hypothesizing that higher Hgb would reduce mortality, and improve survival and quality of life. The trial was terminated early, and a 1998 publication reported that targeting higher hematocrit levels led to an insignificant increase in the primary end points (death or myocardial infarct), or risk ratio 1.3, 95% confidence interval (CI), 0.9-1.90, but the P-value was not given, and all-cause death risk was not reported. A higher target reportedly did not increase hospitalization rates, but did significantly improve the 'physical function' domain of quality of life. Comparing the 1996 Food and Drug Administration (FDA)-filed clinical trial report to the 1998 publication, however, found several discrepancies. Among these, the 1998 article reported interim trial results with only the adjusted CI but did not state that the unadjusted CIs were 99.912th percentile, and despite being a secondary end point, reported only the association of achieved Hgb with higher quality of life score. Randomization to the higher target had actually increased the risk for the primary end point (risk ratio 1.28, 95% CI=1.06-1.56; P=0.0112; 99.92% CI=0.92-1.78), the risk of death (risk ratio 1.27, 95% CI=1.04-1.54), non-access thrombotic events (P=0.041), and hospitalization rate (P=0.04), while 'physical function' did not improve (P=0.88). Hence, disclosure of these results in the 1998 publication or access to the FDA-filed report on the NHT in the late 1990s would likely have led to earlier concerns about epoetin safety and greater doubts about its benefits.

  12. Stroke rehabilitation at home before and after discharge reduced disability and improved quality of life: a randomised controlled trial.

    Science.gov (United States)

    Rasmussen, Rune Skovgaard; Østergaard, Ann; Kjær, Pia; Skerris, Anja; Skou, Christina; Christoffersen, Jane; Seest, Line Skou; Poulsen, Mai Bang; Rønholt, Finn; Overgaard, Karsten

    2016-03-01

    To evaluate if home-based rehabilitation of inpatients improved outcome compared to standard care. Interventional, randomised, safety/efficacy open-label trial. University hospital stroke unit in collaboration with three municipalities. Seventy-one eligible stroke patients (41 women) with focal neurological deficits hospitalised in a stroke unit for more than three days and in need of rehabilitation. Thirty-eight patients were randomised to home-based rehabilitation during hospitalization and for up to four weeks after discharge to replace part of usual treatment and rehabilitation services. Thirty-three control patients received treatment and rehabilitation following usual guidelines for the treatment of stroke patients. Ninety days post-stroke the modified Rankin Scale score was the primary endpoint. Other outcome measures were the modified Barthel-100 Index, Motor Assessment Scale, CT-50 Cognitive Test, EuroQol-5D, Body Mass Index and treatment-associated economy. Thirty-one intervention and 30 control patients completed the study. Patients in the intervention group achieved better modified Rankin Scale score (Intervention median = 2, IQR = 2-3; Control median = 3, IQR = 2-4; P=0.04). EuroQol-5D quality of life median scores were improved in intervention patients (Intervention median = 0.77, IQR = 0.66-0.79; Control median = 0.66, IQR = 0.56 - 0.72; P=0.03). The total amount of home-based training in minutes highly correlated with mRS, Barthel, Motor Assessment Scale and EuroQol-5D™ scores (P-values ranging from Prehabilitation reduced disability and increased quality of life. Compared to standard care, home-based stroke rehabilitation was more cost-effective. © The Author(s) 2015.

  13. A randomized control intervention trial to improve social skills and quality of life in pediatric brain tumor survivors.

    Science.gov (United States)

    Barrera, Maru; Atenafu, Eshetu G; Sung, Lillian; Bartels, Ute; Schulte, Fiona; Chung, Joanna; Cataudella, Danielle; Hancock, Kelly; Janzen, Laura; Saleh, Amani; Strother, Douglas; Downie, Andrea; Zelcer, Shayna; Hukin, Juliette; McConnell, Dina

    2018-01-01

    To determine if a group social skills intervention program improves social competence and quality of life (QOL) in pediatric brain tumor survivors (PBTS). We conducted a randomized control trial in which PBTS (8-16 years old, off therapy for over 3 months) were allocated to receive social skills training (eg, cooperation, assertion, using social cognitive problem solving strategies, role playing, games, and arts and crafts) in 8 weekly 2-hour sessions, or an attention placebo control (games and arts and crafts only). Outcomes were self-reported, proxy-reported (caregiver), and teacher-reported using the Social Skills Rating System (SSRS), to measure social competence, and the Pediatric Quality of Life (PedsQL4.0, generic) to measure QOL at baseline, after intervention, and at 6 months follow-up. At baseline, SSRS were stratified into low and high scores and included as a covariate in the analysis. Compared to controls (n = 48), PBTS in the intervention group (n = 43) reported significantly better total and empathy SSRS scores, with improvements persisting at follow-up. The PBTS in the intervention group who had low scores at baseline reported the greatest improvements. Proxy and teacher reports showed no intervention effect. Participating in group social skills intervention can improve self-reported social competence that persisted to follow up. The PBTS should be given the opportunity to participate in social skills groups to improve social competence. Copyright © 2017 John Wiley & Sons, Ltd.

  14. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  15. Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial).

    Science.gov (United States)

    Fieten, Karin B; Zijlstra, Wieneke T; van Os-Medendorp, Harmieke; Meijer, Yolanda; Venema, Monica Uniken; Rijssenbeek-Nouwens, Lous; l'Hoir, Monique P; Bruijnzeel-Koomen, Carla A; Pasmans, Suzanne G M A

    2014-03-26

    About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking. This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children's Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children's Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters. The results of this trial will provide

  16. High beam quality and high energy short-pulse laser with MOPA

    Science.gov (United States)

    Jin, Quanwei; Pang, Yu; Jiang, JianFeng; Tan, Liang; Cui, Lingling; Wei, Bin; Sun, Yinhong; Tang, Chun

    2018-03-01

    A high energy, high beam quality short-pulse diode-pumped Nd:YAG master oscillator power-amplifier (MOPA) laser with two amplifier stages is demonstrated. The two-rod birefringence compensation was used as beam quality controlling methods, which presents a short-pulse energy of 40 mJ with a beam quality value of M2 = 1.2 at a repetition rate of 400Hz. The MOPA system delivers a short-pulse energy of 712.5 mJ with a pulse width of 12.4 ns.The method of spherical aberration compensation is improved the beam quality, a M2 factor of 2.3 and an optical-to-optical efficiency of 27.7% is obtained at the maximum laser out power.The laser obtained 1.4J out energy with polarization integration.

  17. Satisfaction with the decision to participate in cancer clinical trials is high, but understanding is a problem.

    Science.gov (United States)

    Jefford, M; Mileshkin, L; Matthews, J; Raunow, H; O'Kane, C; Cavicchiolo, T; Brasier, H; Anderson, M; Reynolds, J

    2011-03-01

    Partially presented in poster format at the 40th and 41st Annual Meetings of the American Society of Clinical Oncology, held in 2004 in New Orleans, Louisiana and in 2005 in Orlando, Florida. We aimed to: (a) assess patient knowledge about cancer clinical trials (CCT) and satisfaction with their decision to participate, (b) determine whether satisfaction correlates with objective understanding, or other factors, and (c) identify correlates of increased understanding. A convenience sample of 100 patients were recruited. Instruments assessed quality of informed consent (QuIC), quality of life (EORTC QLQ C-30), anxiety and depression (HADS), and preferences for information and involvement in decision making. Measures were completed within 2 weeks of clinical trial enrollment. One hundred two patients (68 male) with a median age of 58.4 years (29-85) were registered in 27 of the 33 therapeutic cancer clinical trials approved for the Consent Study. Mean QuIC objective knowledge (QuIC-A) was 77.6 (/100) (95% CI, 75.7-79.4) and perceived (subjective) understanding (QuIC-B) 91.5 (95% CI, 89.6-93.3). There was low but significant correlation between QuIC-A and B (R = 0.26, p = 0.008). Satisfaction was very high. Correlation between QuIC-B and satisfaction was moderate (0.430, p < 0.001). QuIC-B, but not QuIC-A was associated with QOL scores. Preferences regarding participation in decision making and whether these preferences were achieved did not impact upon knowledge, understanding or satisfaction. Patient knowledge regarding CCT is similar to published US data, and satisfaction is high. Satisfaction correlates with perceived but not objective understanding of CCT. Strategies to further improve the consent process need to be developed.

  18. Chinese phytotherapy to reduce stress, anxiety and improve quality of life: randomized controlled trial.

    Science.gov (United States)

    Kurebayashi, Leonice Fumiko Sato; Turrini, Ruth Natalia Teresa; Kuba, Gisele; Shimizu, Miki Hoshi Minamizawa; Takiguch, Raymond Sehiji

    2016-01-01

    To evaluate the effect of Chinese phytotherapyto reduce stress levels, anxiety and improve quality of life. double-blind randomized controlled trial with 89 volunteers divided into three groups: control (no intervention), Placebo and Phytotherapy. The study was conducted in 2015 with healthy adults treated at the Integrated and Eastern Therapy Institute,in Sao Paulo, Brazil. Participants were evaluated at baseline and after three weeks with the Stress Symptoms List (SSL), Anxiety Inventory-Trait and State and SF12v2 for quality of life. Intervention groups received a placebo or Gan May Zao formula (GMDZ)flaskwith 50 ml. According to ANOVA, there were significant differences (p = 0.025) after treatment of stress (SSL2). And the difference was between control and Phytotherapy groups, according to the Tukey post hoc (p = 0.022). There were no differences in the levels of state-anxiety and physical and mental domains in the SF12v2. The GMDZ formula reduced stress levels, but more studies are needed with greater sample, with reassessment of dosage and a longer period of treatment to confirm and extend the results. Brazilian Registry of Clinical Trials: RBR-28s4hz. Avaliar o efeito da fitoterapia chinesa na redução de níveis de estresse, ansiedade e melhoria de qualidade de vida. Ensaio clínico randomizado duplo-cego, com 89 voluntários divididos em três grupos: Controle (sem intervenção), Placebo e Fitoterapia. Foi realizado em 2015, com adultos saudáveis atendidos no Instituto de Terapia Integrada e Oriental, São Paulo. Foram avaliados no baseline e, após 3 semanas,pela Lista de Sintomas de Stress (LSS), Inventário de Ansiedade-Traço e Estado e o SF12v2 de qualidade de vida. Os grupos de intervenção receberam um frasco de 50 ml de placebo ou da fórmula Gan Mai Da Zao (GMDZ). Segundo ANOVA, houve diferença (p=0,025) no pós-tratamento de estresse (LSS2). E a diferença foi entre os grupos Controle e Fitoterapia, de acordo com o post hocde Tukey (p=0

  19. Workflow in clinical trial sites & its association with near miss events for data quality: ethnographic, workflow & systems simulation.

    Science.gov (United States)

    de Carvalho, Elias Cesar Araujo; Batilana, Adelia Portero; Claudino, Wederson; Reis, Luiz Fernando Lima; Schmerling, Rafael A; Shah, Jatin; Pietrobon, Ricardo

    2012-01-01

    With the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. However, questions still remain regarding the quality of data being collected in these countries. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil. Two sites in Sao Paolo and Rio Janeiro were evaluated using ethnographic observations of workflow during subject enrolment and data collection. Emerging themes related to threats to near miss events for data quality were derived from observations. They were then transformed into workflows using UML-AD and modeled using System Dynamics. 139 tasks were observed and mapped through the ethnographic study. The UML-AD detected four major activities in the workflow evaluation of potential research subjects prior to signature of informed consent, visit to obtain subject́s informed consent, regular data collection sessions following study protocol and closure of study protocol for a given project. Field observations pointed to three major emerging themes: (a) lack of standardized process for data registration at source document, (b) multiplicity of data repositories and (c) scarcity of decision support systems at the point of research intervention. Simulation with policy model demonstrates a reduction of the rework problem. Patterns of threats to data quality at the two sites were similar to the threats reported in the literature for American sites. The clinical trial site managers need to reorganize staff workflow by using information technology more efficiently, establish new standard procedures and manage professionals to reduce near miss events and save time/cost. Clinical trial

  20. Development of nuclear quality high pressure valve bellows in Canada

    International Nuclear Information System (INIS)

    Janzen, P.; Astill, C.J.

    1978-06-01

    Concurrent with the decision to use bellows stem sealed nuclear valves where feasible in commercial-scale CANDU plants, AECL undertook to develop an indigenous high pressure valve bellows technology. This program included developing the capability to fabricate improved high pressure valve bellows in conjunction with a Canadian manufacturer. This paper describes the evolution of a two-stage bellows fabrication process involving: (1) manufacture of discrete lengths of precision thin wall telescoping tubes - from preparation of strip blanks through edge grinding and edge forming to longitudinal welding; (2) forming of bellows from tube assemblies using a novel combination of mechanical inward forming followed by hydraulic outward forming. Bellows of Inconel 600 and Inconel 625 have been manufactured and evaluated. Test results indicate comparable to improved performance over alternative high quality bellows. (author)

  1. Comparison of investigator-delineated gross tumour volumes and quality assurance in pancreatic cancer: Analysis of the on-trial cases for the SCALOP trial.

    Science.gov (United States)

    Fokas, Emmanouil; Spezi, Emiliano; Patel, Neel; Hurt, Chris; Nixon, Lisette; Chu, Kwun-Ye; Staffurth, John; Abrams, Ross; Mukherjee, Somnath

    2016-08-01

    We performed a retrospective central review of tumour outlines in patients undergoing radiotherapy in the SCALOP trial. The planning CT scans were reviewed retrospectively by a central review team, and the accuracy of investigators' GTV (iGTV) and PTV (iPTV) was compared to the trials team-defined gold standard (gsGTV and gsPTV) using the Jaccard Conformity Index (JCI) and Geographical Miss Index (GMI). The prognostic value of JCI and GMI was also assessed. The RT plans were also reviewed against protocol-defined constraints. 60 patients with diagnostic-quality planning scans were included. The median whole volume JCI for GTV was 0.64 (IQR: 0.43-0.82), and the median GMI was 0.11 (IQR: 0.05-0.22). For PTVs, the median JCI and GMI were 0.80 (IQR: 0.71-0.88) and 0.04 (IQR: 0.02-0.12) respectively. Tumour was completely missed in 1 patient, and⩾50% of the tumour was missed in 3. Patients with JCI for GTV⩾0.7 had 7.12 (95% CIs: 1.83-27.67, p=0.005) higher odds of progressing by 9months in multivariate analysis. Major deviations in RT planning were noted in 4.5% of cases. Radiotherapy workshops and real-time central review of contours are required in RT trials of pancreatic cancer. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  2. Quality of life at 6 months in the Idiopathic Intracranial Hypertension Treatment Trial.

    Science.gov (United States)

    Bruce, Beau B; Digre, Kathleen B; McDermott, Michael P; Schron, Eleanor B; Wall, Michael

    2016-11-01

    To examine the changes in vision-specific and overall health-related quality of life (QOL) at 6 months in participants with idiopathic intracranial hypertension (IIH) and mild visual loss enrolled in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) and to determine the signs and symptoms of IIH that mediate the effect of acetazolamide on QOL. We assessed QOL using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), the 10-Item NEI-VFQ-25 Neuro-Ophthalmic Supplement, and the 36-Item Short Form Health Survey (SF-36). We examined associations among changes in QOL measures over 6 months, treatment status, and changes in signs and symptoms using linear and structural equation models. Among the 165 participants with IIH (86 randomized to acetazolamide, 79 to placebo), beneficial effects of acetazolamide were seen on all QOL scales evaluated, as well as on the Near Activities (5.60 points, p = 0.03), Social Functioning (3.85 points, p = 0.04), and Mental Health (9.82, p = 0.04) subscales of the NEI-VFQ-25. Positive acetazolamide-related effects on QOL appeared to be primarily mediated by improvements in visual field, neck pain, pulsatile tinnitus, and dizziness/vertigo that outweighed the side effects of acetazolamide. The marked reductions in baseline QOL seen among patients with mild visual loss from IIH are improved by treatment with acetazolamide. When combined with acetazolamide-associated improvements in visual field and other aspects of IIH, our findings with respect to QOL provide further support from the IIHTT in favor of acetazolamide to augment a dietary intervention in the treatment of IIH with mild visual loss (clinicaltrials.gov: NCT01003639). © 2016 American Academy of Neurology.

  3. Have CONSORT guidelines improved the quality of reporting of randomised controlled trials published in public health dentistry journals?

    Science.gov (United States)

    Savithra, Prakash; Nagesh, Lakshminarayan Shetty

    2013-01-01

    To assess a) whether the quality of reporting of randomised controlled trials (RCTs) has improved since the formulation of the Consolidated Standards of Reporting Trials (CONSORT) statement and b) whether there is any difference in reporting of RCTs between the selected public health dentistry journals. A hand search of the journals of public health dentistry was performed and four journals were identified for the study. They were Community Dentistry and Oral Epidemiology (CDOE), Community Dental Health (CDH), Journal of Public Health Dentistry (JPHD) and Oral Health and Preventive Dentistry (OHPD). A total of 114 RCTs published between 1990 and 2009 were selected. CONSORT guidelines were applied to each selected article in order to assess and determine any improvement since the publication of CONSORT guidelines. The chi-square test was employed to determine any statistical significant difference in quality of reporting of RCTs before and after the publication of the CONSORT guidelines. A comparison was also done to determine any statistically significant difference in quality of reporting of RCTs between the selected journals. Title, abstract, discussion and conclusion sections of the selected articles showed adherence to the CONSORT guidelines, whereas the compliance was poor with respect to the methodology section. The quality of reporting of RCTs is generally poor in public health dentistry journals. Overall, the quality of reporting has not substantially improved since the publication of CONSORT guidelines.

  4. Fat Quality Influences the Obesogenic Effect of High Fat Diets

    Directory of Open Access Journals (Sweden)

    Raffaella Crescenzo

    2015-11-01

    Full Text Available High fat and/or carbohydrate intake are associated with an elevated risk for obesity and chronic diseases such as diabetes and cardiovascular diseases. The harmful effects of a high fat diet could be different, depending on dietary fat quality. In fact, high fat diets rich in unsaturated fatty acids are considered less deleterious for human health than those rich in saturated fat. In our previous studies, we have shown that rats fed a high fat diet developed obesity and exhibited a decrease in oxidative capacity and an increase in oxidative stress in liver mitochondria. To investigate whether polyunsaturated fats could attenuate the above deleterious effects of high fat diets, energy balance and body composition were assessed after two weeks in rats fed isocaloric amounts of a high-fat diet (58.2% by energy rich either in lard or safflower/linseed oil. Hepatic functionality, plasma parameters, and oxidative status were also measured. The results show that feeding on safflower/linseed oil diet attenuates the obesogenic effect of high fat diets and ameliorates the blood lipid profile. Conversely, hepatic steatosis and mitochondrial oxidative stress appear to be negatively affected by a diet rich in unsaturated fatty acids.

  5. Publishing high-quality climate data on the semantic web

    Science.gov (United States)

    Woolf, Andrew; Haller, Armin; Lefort, Laurent; Taylor, Kerry

    2013-04-01

    The effort over more than a decade to establish the semantic web [Berners-Lee et. al., 2001] has received a major boost in recent years through the Open Government movement. Governments around the world are seeking technical solutions to enable more open and transparent access to Public Sector Information (PSI) they hold. Existing technical protocols and data standards tend to be domain specific, and so limit the ability to publish and integrate data across domains (health, environment, statistics, education, etc.). The web provides a domain-neutral platform for information publishing, and has proven itself beyond expectations for publishing and linking human-readable electronic documents. Extending the web pattern to data (often called Web 3.0) offers enormous potential. The semantic web applies the basic web principles to data [Berners-Lee, 2006]: using URIs as identifiers (for data objects and real-world 'things', instead of documents) making the URIs actionable by providing useful information via HTTP using a common exchange standard (serialised RDF for data instead of HTML for documents) establishing typed links between information objects to enable linking and integration Leading examples of 'linked data' for publishing PSI may be found in both the UK (http://data.gov.uk/linked-data) and US (http://www.data.gov/page/semantic-web). The Bureau of Meteorology (BoM) is Australia's national meteorological agency, and has a new mandate to establish a national environmental information infrastructure (under the National Plan for Environmental Information, NPEI [BoM, 2012a]). While the initial approach is based on the existing best practice Spatial Data Infrastructure (SDI) architecture, linked-data is being explored as a technological alternative that shows great promise for the future. We report here the first trial of government linked-data in Australia under data.gov.au. In this initial pilot study, we have taken BoM's new high-quality reference surface

  6. A Feasibility Study of Moxibustion for Treating Anorexia and Improving Quality of Life in Patients With Metastatic Cancer: A Randomized Sham-Controlled Trial.

    Science.gov (United States)

    Jeon, Ju-Hyun; Cho, Chong-Kwan; Park, So-Jung; Kang, Hwi-Joong; Kim, Kyungmin; Jung, In-Chul; Kim, Young-Il; Lee, Suk-Hoon; Yoo, Hwa-Seung

    2017-03-01

    The aim of this study was to determine the feasibility, acceptability, and safety of using moxibustion for treating anorexia and improving quality of life in patients with metastatic cancer. We conducted a randomized sham-controlled trial of moxibustion. Sixteen patients with metastatic cancer were recruited from Daejeon, South Korea. The patients were randomly placed into a true or a sham moxibustion group and received 10 true or sham moxibustion treatments administered to the abdomen (CV12, CV8, CV4) and legs (ST36) over a 2-week period. Outcome measures included interest in participating in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria, and compliance with the treatment plan (ie, attendance at treatment sessions). Clinical outcomes included results of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), answers on the European Organization for Research and Treatment of Cancer 30-item core quality of life (EORTC QLQ-C30) questionnaires, scores on the visual analogue scale (VAS), and the results from blood tests and a safety evaluation. Moxibustion was an acceptable intervention in patients with metastatic cancer. Compliance with the treatment protocol was high, with 11 patients completing all 10 treatments. No serious adverse events related to moxibustion occurred, but 4 patients in the true moxibustion group reported mild rubefaction, which disappeared in a few hours. This study suggests that moxibustion may be safely used to treat anorexia and improve quality of life in patients with metastatic cancer. However, further research is needed to confirm this result.

  7. High quality electron beams from a laser wakefield accelerator

    Energy Technology Data Exchange (ETDEWEB)

    Wiggins, S M; Issac, R C; Welsh, G H; Brunetti, E; Shanks, R P; Anania, M P; Cipiccia, S; Manahan, G G; Aniculaesei, C; Ersfeld, B; Islam, M R; Burgess, R T L; Vieux, G; Jaroszynski, D A [SUPA, Department of Physics, University of Strathclyde, Glasgow (United Kingdom); Gillespie, W A [SUPA, Division of Electronic Engineering and Physics, University of Dundee, Dundee (United Kingdom); MacLeod, A M [School of Computing and Creative Technologies, University of Abertay Dundee, Dundee (United Kingdom); Van der Geer, S B; De Loos, M J, E-mail: m.wiggins@phys.strath.ac.u [Pulsar Physics, Burghstraat 47, 5614 BC Eindhoven (Netherlands)

    2010-12-15

    High quality electron beams have been produced in a laser-plasma accelerator driven by femtosecond laser pulses with a peak power of 26 TW. Electrons are produced with an energy up to 150 MeV from the 2 mm gas jet accelerator and the measured rms relative energy spread is less than 1%. Shot-to-shot stability in the central energy is 3%. Pepper-pot measurements have shown that the normalized transverse emittance is {approx}1{pi} mm mrad while the beam charge is in the range 2-10 pC. The generation of high quality electron beams is understood from simulations accounting for beam loading of the wakefield accelerating structure. Experiments and self-consistent simulations indicate that the beam peak current is several kiloamperes. Efficient transportation of the beam through an undulator is simulated and progress is being made towards the realization of a compact, high peak brilliance free-electron laser operating in the vacuum ultraviolet and soft x-ray wavelength ranges.

  8. Effect of Educational Program on Quality of Life of Patients with Heart Failure: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Khajegodary

    2013-02-01

    Full Text Available Introduction: Heart failure is one of the most common cardiovascular diseases which decrease the quality of life. Most of the factors influencing the quality of life can be modified with educational interventions. Therefore, this study examined the impact of a continuous training program on quality of life of patients with heart failure. Methods: This randomized clinical trial study was conducted during May to August 2011. Forty four participants with heart failure referred to Shahid Madani's polyclinics of Tabriz were selected through convenient sampling method and were randomly allocated to two groups. The intervention group (n = 22 received ongoing training including one-to-one teaching, counseling sessions and phone calls over 3 months. The control group (n = 22 received routine care program. Data on quality of life was collected using the Minnesota Living with Heart Failure Questionnaire at baseline as well as three months later. Results: The statistical tests showed significant differences in the physical, emotional dimensions and total quality of life in intervention group. But in control group, no significant differences were obtained. There was not any significant association in demographic characteristics and quality of life. Conclusion: Ongoing training programs can be effective in improving quality of life of patients with heart failure. Hence applying ongoing educational program as a non-pharmacological intervention can help to improve the quality of life of these patients.

  9. Effect of educational program on quality of life of patients with heart failure: a randomized clinical trial.

    Science.gov (United States)

    Lakdizaji, Sima; Hassankhni, Hadi; Mohajjel Agdam, Alireza; Khajegodary, Mohammad; Salehi, Rezvanieh

    2013-03-01

    Heart failure is one of the most common cardiovascular diseases which decrease the quality of life. Most of the factors influencing the quality of life can be modified with educational interventions. Therefore, this study examined the impact of a continuous training program on quality of life of patients with heart failure. This randomized clinical trial study was conducted during May to August 2011. Forty four participants with heart failure referred to Shahid Madani's polyclinics of Tabriz were selected through convenient sampling method and were randomly allocated to two groups. The intervention group (n = 22) received ongoing training including one-to-one teaching, counseling sessions and phone calls over 3 months. The control group (n = 22) received routine care program. Data on quality of life was collected using the Minnesota Living with Heart Failure Questionnaire at baseline as well as three months later. The statistical tests showed significant differences in the physical, emotional dimensions and total quality of life in intervention group. But in control group, no significant differences were obtained. There was not any significant association in demographic characteristics and quality of life. Ongoing training programs can be effective in improving quality of life of patients with heart failure. Hence applying ongoing educational program as a non-pharmacological intervention can help to improve the quality of life of these patients.

  10. Sleep quality and its relationship with quality of life among high-risk pregnant women (gestational diabetes and hypertension).

    Science.gov (United States)

    Saadati, Fatemeh; Sehhatiei Shafaei, Fahimeh; Mirghafourvand, Mozhgan

    2018-01-01

    Sleep is one of the most basic human requirements. This research aims at determining the status of sleep quality and its relationship with quality of life among high-risk pregnant women in Tabriz, Iran, in 2015. This research was a sectional study done on 364 qualified women in 28-36 weeks of pregnancy suffering from mild preeclampsia and gestational diabetes. The sampling was done as convenience. Personal-social-midwifery questionnaire, Pittsburg sleep quality, and quality of life in pregnancy (QOL-ORAV) were used for gathering data. Multivariate linear regression model was used for determining the relationship between sleep quality and its subsets with quality of life and controlling confounders. In the current study, the prevalence of sleep disturbance was 96.4%. Mean (SD) of the total score of sleep quality was 10.1 (4.1) and the total score of quality of life was 61.7 (17.3). According to Pearson's correlation test, there was statistically significant relationship between quality of life and sleep quality and all its subsets except sleep duration and use of sleep medication (p quality of life. The findings of current research show that sleep quality is low among high-risk pregnant women and quality of life is medium. So, it is necessary that required training is given by health cares for improving sleep quality and quality of life to mothers.

  11. Trial manufacture of liquid nitrogen cooling High Temperature Superconductivity Motor

    International Nuclear Information System (INIS)

    Sugimoto, H; Nishikawa, T; Tsuda, T; Hondou, Y; Akita, Y; Takeda, T; Okazaki, T; Ohashi, S; Yoshida, Y

    2006-01-01

    We present a new high temperature superconductivity (HTS) synchronous motor using the liquid nitrogen as the refrigerant in this paper. This motor is designed to be used as the propulsion motor in ship. Because we use the liquid nitrogen as the refrigerant, it is possible to simplify the cooling equipments in the motor. And in our design, we apply the axial flux type of motor to simplify the cryostat of the HTS wires used to make the field coils. Here, the fields using the bismuth HTS wire for the HTS coils are fixed. Moreover, the cores used in the fields are separated from cryostat, and the armature applies the core-less structure. According to various the electromagnetic field analysis results, the new motor was designed and produced. The diameter of the motor is 650mm, and the width of the motor is 360mm. The motor's rated output is 8.8kW at 100rpm, while the overload output is 44kW, and the maximum efficiency is 97.7%. Also, in order to further miniaturize the motor, other magnetic field analysis have been done when the high-current-density type HTS wire was used and the permendur was used instead of magnetic steel plates. In this case, the motor's rated output is 12kW, and the overload output is 60kW

  12. Present status of high quality beam facility at Waseda University

    International Nuclear Information System (INIS)

    Washio, M.; Kawai, H.; Hama, Y.; Kudo, N.; Kobayashi, M.; Kuribayasi, T.; Kawaguchi, M.; Kuroda, R.; Maeda, K.; Nagasawa, F.; Ueyama, D.; Hizume, K.; Wang, X.J.; Hayano, H.; Urakawa, J.; Kashiwagi, S.

    2004-01-01

    A research project named High-Tech Research Center Project has been conducted at Waseda University. In this project, an RF gun system has been used for production of low emittance and short bunched electron beam. The experiments for the electron beam quality measurement have been carried out by slit scan techniques, etc. Short pulsed x-ray with the energy range of so-called water window has been generation by the inverse compton scattering. Further, the pulse radiolysis system has been constructed, and the stroboscopic pulse radiolysis has been applied for the detection of hydrated electron in picosecond time region. (author)

  13. Anti-Stokes Luminescence in High Quality Quantum Wells

    Science.gov (United States)

    Vinattieri, A.; Bogani, F.; Miotto, A.; Ceccherini, S.

    1997-11-01

    We present a detailed investigation of the anti-Stokes (AS) luminescence which originates from exciton recombination when below gap excitation is used, in a set of high quality quantum well structures. We observe strong excitonic resonances in the AS signal as measured from photoluminescence and photoluminescence excitation spectra. We demonstrate that neither the electromagnetic coupling between the wells nor the morphological disorder can explain this up-conversion effect. Time-resolved luminescence data after ps excitation and fs correlation spectroscopy results provide clear evidence of the occurrence of a two-step absorption which is assisted by the exciton population resonantly excited by the first photon.

  14. The quality of high-energy X-ray beams

    International Nuclear Information System (INIS)

    LaRiviere, P.D.

    1989-01-01

    Supplement 17 of the British Journal of Radiology is a survey of central-axis depth doses for radiotherapy machines, patterned largely on BJR Supplement 11 (1972). Inspection of high-energy X-ray depth doses for a 10 x 10 cm field at an SSD of 100 cm disclosed large differences between the two sets of data, especially for qualities above 8 MV, e.g. a depth dose of 80% at 10 cm is rated at about 19 MV according to BJR Supplement 11, and 23 MV according to BJR Supplement 17. It was found that Supplement 17 depth-dose data above 8 MV were erratic, but Supplement 11 data could be represented by an analytical expression, providing a unique means of assigning MV quality. It was also found that dose-weighted average energy of the filtered beam plotted smoothly against depth dose. For dosimetric purposes, it is suggested that this parameter be used as a true measure of beam quality, removing discrepancies introduced by the use of nominal MV for this purpose. (author)

  15. CCD Astrophotography High-Quality Imaging from the Suburbs

    CERN Document Server

    Stuart, Adam

    2006-01-01

    This is a reference book for amateur astronomers who have become interested in CCD imaging. Those glorious astronomical images found in astronomy magazines might seem out of reach to newcomers to CCD imaging, but this is not the case. Great pictures are attainable with modest equipment. Adam Stuart’s many beautiful images, reproduced in this book, attest to the quality of – initially – a beginner’s efforts. Chilled-chip astronomical CCD-cameras and software are also wonderful tools for cutting through seemingly impenetrable light-pollution. CCD Astrophotography from the Suburbs describes one man’s successful approach to the problem of getting high-quality astronomical images under some of the most light-polluted conditions. Here is a complete and thoroughly tested program that will help every CCD-beginner to work towards digital imaging of the highest quality. It is equally useful to astronomers who have perfect observing conditions, as to those who have to observe from light-polluted city skies.

  16. Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years.

    Science.gov (United States)

    Lemieux, Julie; Brundage, Michael D; Parulekar, Wendy R; Goss, Paul E; Ingle, James N; Pritchard, Kathleen I; Celano, Paul; Muss, Hyman; Gralow, Julie; Strasser-Weippl, Kathrin; Whelan, Kate; Tu, Dongsheng; Whelan, Timothy J

    2018-02-20

    Purpose MA.17R was a Canadian Cancer Trials Group-led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor-positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL.

  17. Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years

    Science.gov (United States)

    Brundage, Michael D.; Parulekar, Wendy R.; Goss, Paul E.; Ingle, James N.; Pritchard, Kathleen I.; Celano, Paul; Muss, Hyman; Gralow, Julie; Strasser-Weippl, Kathrin; Whelan, Kate; Tu, Dongsheng; Whelan, Timothy J.

    2018-01-01

    Purpose MA.17R was a Canadian Cancer Trials Group–led phase III randomized controlled trial comparing letrozole to placebo after 5 years of aromatase inhibitor as adjuvant therapy for hormone receptor–positive breast cancer. Quality of life (QOL) was a secondary outcome measure of the study, and here, we report the results of these analyses. Methods QOL was measured using the Short Form-36 (SF-36; two summary scores and eight domains) and menopause-specific QOL (MENQOL; four symptom domains) at baseline and every 12 months up to 60 months. QOL assessment was mandatory for Canadian Cancer Trials Group centers but optional for centers in other groups. Mean change scores from baseline were calculated. Results One thousand nine hundred eighteen women were randomly assigned, and 1,428 women completed the baseline QOL assessment. Compliance with QOL measures was > 85%. Baseline summary scores for the SF-36 physical component summary (47.5 for letrozole and 47.9 for placebo) and mental component summary (55.5 for letrozole and 54.8 for placebo) were close to the population norms of 50. No differences were seen between groups in mean change scores for the SF-36 physical and mental component summaries and the other eight QOL domains except for the role-physical subscale. No difference was found in any of the four domains of the MENQOL Conclusion No clinically significant differences were seen in overall QOL measured by the SF-36 summary measures and MENQOL between the letrozole and placebo groups. The data indicate that continuation of aromatase inhibitor therapy after 5 years of prior treatment in the trial population was not associated with a deterioration of overall QOL. PMID:29328860

  18. The effect of nabilone on appetite, nutritional status, and quality of life in lung cancer patients: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Turcott, Jenny G; Del Rocío Guillen Núñez, María; Flores-Estrada, Diana; Oñate-Ocaña, Luis F; Zatarain-Barrón, Zyanya Lucia; Barrón, Feliciano; Arrieta, Oscar

    2018-03-17

    Over one half of the patients diagnosed with advanced lung cancer experience anorexia. In addition to its high incidence, cancer-induced anorexia promotes the development of the anorexia-cachexia syndrome, which is related to poor clinical outcomes. Recently, drugs derived from cannabinoids, such as Nabilone, have been recognized for their appetite improvement properties; however, clinical trials to support their use in cancer patients are necessary. This is a randomized, double-blind, placebo-controlled clinical trial to assess the effect of Nabilone vs. placebo on the appetite, nutritional status, and quality of life in patients diagnosed with advanced Non-small cell lung cancer (NSCLC) (NCT02802540). A total of 65 patients from the outpatient clinic at the National Institute of Cancer (INCan) were assessed for eligibility and 47 were randomized to receive Nabilone (0.5 mg/2 weeks followed by 1.0 mg/6 weeks) or placebo. After 8 weeks of treatment, patients who received Nabilone increased their caloric intake (342-kcal) and had a significantly higher intake of carbohydrates (64 g) compared to patients receiving placebo (p = 0.040). Quality of life also showed significant improvements in patients in the experimental arm of the trial, particularly in role functioning (p = 0.030), emotional functioning (p = 0.018), social functioning (p = 0.036), pain (p = 0.06), and insomnia (p = 0.020). No significant change in these scales was seen in the control group. Nabilone is an adequate and safe therapeutic option to aid in the treatment of patients diagnosed with anorexia. Larger trials are necessary in order to draw robust conclusions in regard to its efficacy in lung cancer patients.

  19. Psychometric performance and responsiveness of the functional outcomes of sleep questionnaire and sleep apnea quality of life instrument in a randomized trial: the HomePAP study.

    Science.gov (United States)

    Billings, Martha E; Rosen, Carol L; Auckley, Dennis; Benca, Ruth; Foldvary-Schaefer, Nancy; Iber, Conrad; Zee, Phyllis C; Redline, Susan; Kapur, Vishesh K

    2014-12-01

    Measures of health-related quality of life (HRQL) specific for sleep disorders have had limited psychometric evaluation in the context of randomized controlled trials (RCTs). We investigated the psychometric properties of the Functional Outcomes of Sleep Questionnaire (FOSQ) and Sleep Apnea Quality of Life Instrument (SAQLI). We evaluated the FOSQ and SAQLI construct and criterion validity, determined a minimally important difference, and assessed for associations of responsiveness to baseline subject characteristics and continuous positive airway pressure (CPAP) adherence in a RCT population. Secondary analysis of data collected in a multisite RCT of home versus laboratory-based diagnosis and treatment of obstructive sleep apnea (HomePAP trial). Individuals enrolled in the HomePAP trial (n = 335). N/A. The FOSQ and SAQLI subscores demonstrated high reliability and criterion validity, correlating with Medical Outcomes Study 36-Item Short Form Survey domains. Correlations were weaker with the Epworth Sleepiness Scale (ESS). Both the FOSQ and SAQLI scores improved after 3 mo with CPAP therapy. Averaging 4 h or more of CPAP use was associated with an increase in the FOSQ beyond the minimally important difference. Baseline depressive symptoms and sleepiness predicted FOSQ and SAQLI responsiveness; demographic, objective obstructive sleep apnea (OSA) severity and sleep habits were not predictive in linear regression. The FOSQ and SAQLI are responsive to CPAP intervention, with the FOSQ being more sensitive to differences in CPAP adherence than the SAQLI. These instruments provide unique information about health outcomes beyond that provided by changes in physiological measures of OSA severity (apnea-hypopnea index). Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP) URL: http://clinicaltrials.gov/show/NCT00642486. NIH clinical trials registry number: NCT00642486. © 2014 Associated Professional Sleep Societies, LLC.

  20. Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Legemate, Catherine M; Goei, Harold; Middelkoop, Esther; Oen, Irma M M H; Nijhuis, Tim H J; Kwa, Kelly A A; van Zuijlen, Paul P M; Beerthuizen, Gerard I J M; Nieuwenhuis, Marianne K; van Baar, Margriet E; van der Vlies, Cornelis H

    2018-04-19

    Deep dermal burns require tangential excision of non-viable tissue and skin grafting to improve wound healing and burn-scar quality. Tangential excision is conventionally performed with a knife, but during the last decade hydrosurgery has become popular as a new tool for tangential excision. Hydrosurgery is generally thought to be a more precise and controlled manner of burn debridement leading to preservation of viable tissue and, therefore, better scar quality. Although scar quality is considered to be one of the most important outcomes in burn surgery today, no randomized controlled study has compared the effect of these two common treatment modalities with scar quality as a primary outcome. The aim of this study is, therefore, to compare long-term scar quality after hydrosurgical versus conventional tangential excision in deep dermal burns. A multicenter, randomized, intra-patient, controlled trial will be conducted in the Dutch burn centers of Rotterdam, Beverwijk, and Groningen. All patients with deep dermal burns that require excision and grafting are eligible. Exclusion criteria are: a burn wound burned > 30%, full-thickness burns, chemical or electrical burns, infected wounds (clinical symptoms in combination with positive wound swabs), insufficient knowledge of the Dutch or English language, patients that are unlikely to comply with requirements of the study protocol and follow-up, and patients who are (temporarily) incompetent because of sedation and/or intubation. A total of 137 patients will be included. Comparable wound areas A and B will be appointed, randomized and either excised conventionally with a knife or with the hydrosurgery system. The primary outcome is scar quality measured by the observer score of the Patient and Observer Scar Assessment Scale (POSAS); a subjective scar-assessment instrument, consisting of two separate six-item scales (observer and patient) that are both scored on a 10-point rating scale. This study will contribute to

  1. A quality assurance audit: phase iii trial of maximal androgen deprivation in prostate cancer (TROG 96.01)

    International Nuclear Information System (INIS)

    Steigler, A.; Kovacev, O.; Denham, J.; Lamb, D.; North, J.

    2000-01-01

    In 1997 the Trans-Tasman Radiation Oncology Group (TROG) performed a quality assurance (QA) audit of its phase III randomized clinical trial investigating the effectiveness of different durations of maximal androgen deprivation prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate (TROG 96.01). The audit reviewed a total of 60 cases from 15 centres across Australia and New Zealand. In addition to verification of technical adherence to the protocol, the audit also incorporated a survey of centre planning techniques and a QA time/cost analysis. The present report builds on TROG's first technical audit conducted in 1996 for the phase III accelerated head and neck trial (TROG 91.01) and highlights the significant progress TROG has made in the interim period. The audit provides a strong validation of the results of the 96.01 trial, as well as valuable budgeting and treatment planning information for future trials. Overall improvements were detected in data quality and quantity, and in protocol compliance, with a reduction in the rate of unacceptable protocol violations from 10 to 4%. Audit design, staff education and increased data management resources were identified as the main contributing factors to these improvements. In addition, a budget estimate of $100 per patient has been proposed for conducting similar technical audits. The next major QA project to be undertaken by TROG during the period 1998-1999 is an intercentre dosimetry study. Trial funding and staff education have been targeted as the key major issues essential to the continued success and expansion of TROG's QA programme. Copyright (1999) Blackwell Science Pty Ltd

  2. A quality assurance audit: phase III trial of maximal androgen deprivation in prostate cancer (TROG 96.01).

    Science.gov (United States)

    Steigler, A; Mameghan, H; Lamb, D; Joseph, D; Matthews, J; Franklin, I; Turner, S; Spry, N; Poulsen, M; North, J; Kovacev, O; Denham, J

    2000-02-01

    In 1997 the Trans-Tasman Radiation Oncology Group (TROG) performed a quality assurance (QA) audit of its phase III randomized clinical trial investigating the effectiveness of different durations of maximal androgen deprivation prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate (TROG 96.01). The audit reviewed a total of 60 cases from 15 centres across Australia and New Zealand. In addition to verification of technical adherence to the protocol, the audit also incorporated a survey of centre planning techniques and a QA time/cost analysis. The present report builds on TROG's first technical audit conducted in 1996 for the phase III accelerated head and neck trial (TROG 91.01) and highlights the significant progress TROG has made in the interim period. The audit provides a strong validation of the results of the 96.01 trial, as well as valuable budgeting and treatment planning information for future trials. Overall improvements were detected in data quality and quantity, and in protocol compliance, with a reduction in the rate of unacceptable protocol violations from 10 to 4%. Audit design, staff education and increased data management resources were identified as the main contributing factors to these improvements. In addition, a budget estimate of $100 per patient has been proposed for conducting similar technical audits. The next major QA project to be undertaken by TROG during the period 1998-1999 is an intercentre dosimetry study. Trial funding and staff education have been targeted as the key major issues essential to the continued success and expansion of TROG's QA programme.

  3. Next-generation audit and feedback for inpatient quality improvement using electronic health record data: a cluster randomised controlled trial.

    Science.gov (United States)

    Patel, Sajan; Rajkomar, Alvin; Harrison, James D; Prasad, Priya A; Valencia, Victoria; Ranji, Sumant R; Mourad, Michelle

    2018-03-05

    Audit and feedback improves clinical care by highlighting the gap between current and ideal practice. We combined best practices of audit and feedback with continuously generated electronic health record data to improve performance on quality metrics in an inpatient setting. We conducted a cluster randomised control trial comparing intensive audit and feedback with usual audit and feedback from February 2016 to June 2016. The study subjects were internal medicine teams on the teaching service at an urban tertiary care hospital. Teams in the intensive feedback arm received access to a daily-updated team-based data dashboard as well as weekly inperson review of performance data ('STAT rounds'). The usual feedback arm received ongoing twice-monthly emails with graphical depictions of team performance on selected quality metrics. The primary outcome was performance on a composite discharge metric (Discharge Mix Index, 'DMI'). A washout period occurred at the end of the trial (from May through June 2016) during which STAT rounds were removed from the intensive feedback arm. A total of 40 medicine teams participated in the trial. During the intervention period, the primary outcome of completion of the DMI was achieved on 79.3% (426/537) of patients in the intervention group compared with 63.2% (326/516) in the control group (Paudit and feedback using timely data and STAT rounds significantly increased performance on a composite discharge metric compared with usual feedback. With the cessation of STAT rounds, performance between the intensive and usual feedback groups did not differ significantly, highlighting the importance of feedback delivery on effecting change. The trial was registered with ClinicalTrials.gov (NCT02593253). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. Controlled rehabilitative and supportive care intervention trials in patients with high-grade gliomas and their caregivers

    DEFF Research Database (Denmark)

    Piil, K; Juhler, M; Jakobsen, J

    2016-01-01

    and Embase were searched for literature published from 1995 to May 2013. Data from eight studies were reviewed for substantive methods and results. Methodological quality was described and assessed using the scoring system for appraising mixed methods research and concomitantly appraising qualitative......, quantitative and mixed methods primary studies in mixed study reviews. RESULTS: The search yielded 914 unique publications, of which 9 were classified eligible for this review. There is preliminary evidence that cognitive group therapy improves memory skills in patients with high-grade gliomas, early physical....... CONCLUSIONS: As evidence is beginning to emerge, there is a need for well-designed longitudinal and randomised controlled trials of non-pharmacological interventions in high-grade glioma patients and their caregivers in order to develop clinical guidelines for supportive and rehabilitative approaches...

  5. The addition of voice prompts to audiovisual feedback and debriefing does not modify CPR quality or outcomes in out of hospital cardiac arrest--a prospective, randomized trial.

    Science.gov (United States)

    Bohn, Andreas; Weber, Thomas P; Wecker, Sascha; Harding, Ulf; Osada, Nani; Van Aken, Hugo; Lukas, Roman P

    2011-03-01

    Chest compression quality is a determinant of survival from out-of-hospital cardiac arrest (OHCA). ERC 2005 guidelines recommend the use of technical devices to support rescuers giving compressions. This prospective randomized study reviewed influence of different feedback configurations on survival and compression quality. 312 patients suffering an OHCA were randomly allocated to two different feedback configurations. In the limited feedback group a metronome and visual feedback was used. In the extended feedback group voice prompts were added. A training program was completed prior to implementation, performance debriefing was conducted throughout the study. Survival did not differ between the extended and limited feedback groups (47.8% vs 43.9%, p = 0.49). Average compression depth (mean ± SD: 4.74 ± 0.86 cm vs 4.84 ± 0.93 cm, p = 0.31) was similar in both groups. There were no differences in compression rate (103 ± 7 vs 102 ± 5 min(-1), p=0.74) or hands-off fraction (16.16% ± 0.07 to 17.04% ± 0.07, p = 0.38). Bystander CPR, public arrest location, presenting rhythm and chest compression depth were predictors of short term survival (ROSC to ED). Even limited CPR-feedback combined with training and ongoing debriefing leads to high chest compression quality. Bystander CPR, location, rhythm and chest compression depth are determinants of survival from out of hospital cardiac arrest. Addition of voice prompts does neither modify CPR quality nor outcome in OHCA. CC depth significantly influences survival and therefore more focus should be put on correct delivery. Further studies are needed to examine the best configuration of feedback to improve CPR quality and survival. ClinicalTrials.gov (NCT00449969), http://www.clinicalTrials.gov. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  6. Percutaneous vertebroplasty with a high-quality rotational angiographic unit

    Energy Technology Data Exchange (ETDEWEB)

    Pedicelli, Alessandro [Department of Bioimaging and Radiological Sciences, Catholic University of Sacred Heart, Policl. A.Gemelli, l.go Gemelli 1, 00168 Rome (Italy)], E-mail: apedicelli@rm.unicatt.it; Rollo, Massimo [Department of Bioimaging and Radiological Sciences, Catholic University of Sacred Heart, Policl. A.Gemelli, l.go Gemelli 1, 00168 Rome (Italy)], E-mail: mrollo@rm.unicatt.it; Piano, Mariangela [Department of Bioimaging and Radiological Sciences, Catholic University of Sacred Heart, Policl. A.Gemelli, l.go Gemelli 1, 00168 Rome (Italy)], E-mail: mariangela.piano@gmail.com; Re, Thomas J. [Department of Bioimaging and Radiological Sciences, Catholic University of Sacred Heart, Policl. A.Gemelli, l.go Gemelli 1, 00168 Rome (Italy)], E-mail: tomjre@gmail.com; Cipriani, Maria C. [Department of Gerontology, Catholic University of Sacred Heart, Policl. A.Gemelli, l.go Gemelli 1, 00168 Rome (Italy)], E-mail: alexped@yahoo.com; Colosimo, Cesare [Department of Bioimaging and Radiological Sciences, Catholic University of Sacred Heart, Policl. A.Gemelli, l.go Gemelli 1, 00168 Rome (Italy)], E-mail: colosimo@rm.unicatt.it; Bonomo, Lorenzo [Department of Bioimaging and Radiological Sciences, Catholic University of Sacred Heart, Policl. A.Gemelli, l.go Gemelli 1, 00168 Rome (Italy)], E-mail: lbonomo@rm.unicatt.it

    2009-02-15

    We evaluated the reliability of a rotational angiographic unit (RA) with flat-panel detector as a single technique to guide percutaneous vertebroplasty (PVP) and for post-procedure assessment by 2D and 3D reformatted images. Fifty-five consecutive patients (104 vertebral bodies) were treated under RA fluoroscopy. Rotational acquisitions with 2D and 3D reconstruction were obtained in all patients for immediate post-procedure assessment. In complex cases, this technique was also used to evaluate the needle position during the procedure. All patients underwent CT scan after the procedure. RA and CT findings were compared. In all cases, a safe trans-pedicular access and an accurate control of the bone-cement injection were successfully performed with high-quality fluoroscopy, even at the thoracic levels and in case of vertebra plana. 2D and 3D rotational reconstructions permitted CT-like images that clearly showed needle position and were similar to CT findings in depicting intrasomatic implant-distribution. RA detected 40 cement leakages compared to 42 demonstrated by CT and showed overall 95% sensitivity and 100% specificity compared to CT for final post-procedure assessment. Our preliminary results suggest that high-quality RA is reliable and safe as a single technique for PVP guidance, control and post-procedure assessment. It permits fast and cost-effective procedures avoiding multi-modality imaging.

  7. Computer-aided control of high-quality cast iron

    Directory of Open Access Journals (Sweden)

    S. Pietrowski

    2008-04-01

    Full Text Available The study discusses the possibility of control of the high-quality grey cast iron and ductile iron using the author’s genuine computer programs. The programs have been developed with the help of algorithms based on statistical relationships that are said to exist between the characteristic parameters of DTA curves and properties, like Rp0,2, Rm, A5 and HB. It has been proved that the spheroidisation and inoculation treatment of cast iron changes in an important way the characteristic parameters of DTA curves, thus enabling a control of these operations as regards their correctness and effectiveness, along with the related changes in microstructure and mechanical properties of cast iron. Moreover, some examples of statistical relationships existing between the typical properties of ductile iron and its control process were given for cases of the melts consistent and inconsistent with the adopted technology.A test stand for control of the high-quality cast iron and respective melts has been schematically depicted.

  8. Automated high speed volume computed tomography for inline quality control

    International Nuclear Information System (INIS)

    Hanke, R.; Kugel, A.; Troup, P.

    2004-01-01

    Increasing complexity of innovative products as well as growing requirements on quality and reliability call for more detailed knowledge about internal structures of manufactured components rather by 100 % inspection than just by sampling test. A first-step solution, like radioscopic inline inspection machines, equipped with automated data evaluation software, have become state of the art in the production floor during the last years. However, these machines provide just ordinary two-dimensional information and deliver no volume data e.g. to evaluate exact position or shape of detected defects. One way to solve this problem is the application of X-ray computed tomography (CT). Compared to the performance of the first generation medical scanners (scanning times of many hours), today, modern Volume CT machines for industrial applications need about 5 minutes for a full object scan depending on the object size. Of course, this is still too long to introduce this powerful method into the inline production quality control. In order to gain acceptance, the scanning time including subsequent data evaluation must be decreased significantly and adapted to the manufacturing cycle times. This presentation demonstrates the new technical set up, reconstruction results and the methods for high-speed volume data evaluation of a new fully automated high-speed CT scanner with cycle times below one minute for an object size of less than 15 cm. This will directly create new opportunities in design and construction of more complex objects. (author)

  9. Production of high quality water for oil sands application

    Energy Technology Data Exchange (ETDEWEB)

    Beaudette-Hodsman, C.; Macleod, B. [Pall Corp., Mississauga, ON (Canada); Venkatadri, R. [Pall Corp., East Hills, NY (United States)

    2008-10-15

    This paper described a pressurized microfiltration membrane system installed at an oil sands extraction site in Alberta. The system was designed to complement a reverse osmosis (RO) system installed at the site to produce the high quality feed water required by the system's boilers. Groundwater in the region exhibited moderate total suspended solids and high alkalinity and hardness levels, and the RO system required feed water with a silt density index of 3 or less. The conventional pretreatment system used at the site was slowing down production due to the severe fouling of the RO membranes. The new microfiltration system contained an automated PVDF hollow fiber microfiltration membrane system contained in a trailer. Suspended particles and bacteria were captured within the filter, and permeate was sent to the RO unit. Within 6 hours of being installed, the unit was producing water with SDI values in the range of 1.0 to 2.5. It was concluded that the microfiltration system performed reliably regardless of wide variations in feed water quality and flow rates. 3 refs., 1 tab., 8 figs.

  10. Quality of registration for clinical trials published in emergency medicine journals.

    Science.gov (United States)

    Jones, Christopher W; Platts-Mills, Timothy F

    2012-10-01

    In 2005, the International Committee of Medical Journal Editors established clinical trial registration as a requirement for articles submitted to member journals, with the goal of improving the transparency of clinical research. The objective of this study is to characterize the registration of clinical trials published in emergency medicine journals. Randomized trials involving human subjects and published between June 1, 2008, and May 31, 2011 in the 5 emergency medicine journals with the highest impact factors were included. We assessed the clarity of registered primary outcomes, timing of registration relative to patient enrollment, and consistency between registered and published outcomes. Of the 123 trials included, registry entries were identified for 57 (46%). Of the 57 registered studies, 45 (79%) were registered after the initiation of subject enrollment, 9 (16%) had registered outcomes that were unclear, and 26 (46%) had discrepancies between registered and published outcomes. Only 5 studies were registered before patient enrollment with a clear primary outcome that was consistent with the published primary outcome. Annals of Emergency Medicine was the only journal in which the majority of trials were registered. Current compliance with clinical trial registration guidelines is poor among trials published in emergency medicine journals. Copyright © 2012. Published by Mosby, Inc.

  11. High Framingham risk score decreases quality of life in adults

    Directory of Open Access Journals (Sweden)

    Christian Yosaputra

    2010-04-01

    Full Text Available Cardiovascular disease (CVD risk factors, such as diabetes, hypertension, hypercholesterolemia, smoking, and obesity tend to occur together in the general population. Increasing prevalence of multiple CVD risk factors has been related to increased risk of death from coronary heart disease and stroke. Studies have suggested that people with several risk factors of CVD may have impaired health-related quality of life. The objective of this study was to assess the association of CVD risk factors with quality of life (QOL among adults aged 40 to 65 years. A cross-sectional study was conducted involving 220 subjects 40 - 65 years of age at a health center. The CVD risk factors were assessed using the Framingham risk score that is the standard instrument for assessment of the risk of a first cardiac event. The risk factors assessed were age, smoking, blood pressure, total cholesterol and high density lipoprotein cholesterol concentrations. QOL was assessed by means of the WHOQOL-BREF instrument that had been prevalidated. The results of the study showed that 28.2% of subjects were smokers, 56.4% had stage 1 hypertension, 42.8% high total cholesterol and 13.6% low HDL cholesterol. The high risk group amounted to 45.5% and 42.3% constitued an intermediate risk group. High CVD risk scores were significantly associated with a low QOL for all domains (physical, psychological, social and environment (p=0.000. Preventing or reducing the multiple CVD risk factors to improve QOL is necessary among adults.

  12. Evaluating quality of life and cost implications of prophylactic radiotherapy in mesothelioma: Health economic analysis of the SMART trial.

    Directory of Open Access Journals (Sweden)

    Samuel Alan Stewart

    Full Text Available The SMART trial is a UK-based, multicentre RCT comparing prophylactic radiotherapy and symptom-based (deferred radiotherapy in 203 patients with Malignant Pleural Mesothelioma who had undergone large bore pleural interventions. Using costs and quality of life data collected alongside the clinical trial, we will estimate the cost-effectiveness of prophylactic radiotherapy compared to deferred radiotherapy over a 1-year period.Healthcare utilization and costs were captured during the trial. Utility weights produced by the EQ-5D questionnaire were used to determine quality-adjusted life-years (QALY gained. The incremental cost-effectiveness ratio was calculated over the one-year trial period.Costs were similar in the immediate and deferred radiotherapy groups: £5480.40 (SD = £7040; n = 102 and £5461.40 (SD = £7770; n = 101 respectively. There was also no difference in QALY: 0.498 (95% CI: [0.45, 0.547] in the prophylactic radiotherapy group versus 0.525 (95% CI: [0.471, 0.580] in the deferred group. At a willingness to pay threshold of £30,000/QALY there was only a 24% chance that prophylactic radiotherapy was cost-effective compared to deferred radiotherapy.There was no significant effect of prophylactic radiotherapy on quality of life in the intervention group, nor was there any discernable decrease in healthcare costs. There is little evidence to suggest that prophylactic radiotherapy is a cost-effective intervention in this population.ISRCTN72767336 with ISRCTN.

  13. Improving the quality of depression and pain care in multiple sclerosis using collaborative care: The MS-care trial protocol.

    Science.gov (United States)

    Ehde, Dawn M; Alschuler, Kevin N; Sullivan, Mark D; Molton, Ivan P; Ciol, Marcia A; Bombardier, Charles H; Curran, Mary C; Gertz, Kevin J; Wundes, Annette; Fann, Jesse R

    2018-01-01

    Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care, which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting. We describe a 16-week randomized controlled trial comparing the MS Care collaborative care intervention to usual care in an outpatient MS specialty center. Eligible participants with chronic pain of at least moderate intensity (≥3/10) and/or major depressive disorder are randomly assigned to MS Care or usual care. MS Care utilizes a care manager to implement and coordinate guideline-based medical and behavioral treatments with the patient, clinic providers, and pain/depression treatment experts. We will compare outcomes at post-treatment and 6-month follow up. We hypothesize that participants randomly assigned to MS Care will demonstrate significantly greater control of both pain and depression at post-treatment (primary endpoint) relative to those assigned to usual care. Secondary analyses will examine quality of care, patient satisfaction, adherence to MS care, and quality of life. Study findings will aid patients, clinicians, healthcare system leaders, and policy makers in making decisions about effective care for pain and depression in MS healthcare systems. (PCORI- IH-1304-6379; clinicaltrials.gov: NCT02137044). This trial is registered at ClinicalTrials.gov, protocol NCT02137044. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2018-02-13

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

  15. Economic evidence for the clinical management of major depressive disorder: a systematic review and quality appraisal of economic evaluations alongside randomised controlled trials.

    Science.gov (United States)

    Karyotaki, E; Tordrup, D; Buntrock, C; Bertollini, R; Cuijpers, P

    2017-10-01

    The aim of this systematic review of economic evaluations alongside randomised controlled trials (RCTs) was to provide a comprehensive overview of the evidence concerning cost-effectiveness analyses of common treatment options for major depression. An existing database was used to identify studies reporting cost-effectiveness results from RCTs. This database has been developed by a systematic literature search in the bibliographic databases of PubMed, PsychINFO, Embase and Cochrane library from database inception to December 2014. We evaluated the quality of economic evaluations using a 10-item short version of the Drummond checklist. Results were synthesised narratively. The risk of bias of the included RCTs was assessed, based on the Cochrane risk of bias assessment tool. Fourteen RCTs were included from the 5580 articles screened on titles and abstracts. The methodological quality of the health economic evaluations was relatively high and the majority of the included RCTs had low risk of bias in most of Cochrane items except blinding of participants and personnel. Cognitive behavioural therapy was examined in seven trials as part of a variety of treatment protocols and seems cost-effective compared with pharmacotherapy in the long-term. However cost-effectiveness results for the combination of psychotherapy with pharmacotherapy are conflicting and should be interpreted with caution due to limited comparability between the examined trials. For several treatments, only a single economic evaluation was reported as part of a clinical trial. This was the case for comparisons between different classes of antidepressants, for several types of psychotherapy (behavioural activation, occupational therapy, interpersonal psychotherapy, short-term psychotherapy, psychodynamic psychotherapy, rational emotive behavioural therapy, solution focused therapy), and for transcranial magnetic stimulation v. electroconvulsive therapy. The limited evidence base for these interventions

  16. The effects of exercise on the quality of life of patients with breast cancer (the UMBRELLA Fit study) : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Gal, Roxanne; Monninkhof, Evelyn M; Groenwold, Rolf H H; van Gils, Carla H; van den Bongard, Desiree H J G; Peeters, Petra H M; Verkooijen, Helena M; May, Anne M

    2017-01-01

    BACKGROUND: Meta-analyses of randomized controlled trials (RCTs) have shown that exercise has beneficial effects on quality of life (QoL) in patients with breast cancer. However, these effects were often small. Blinding in an exercise trial is not possible, which has the possible disadvantage of

  17. Automated Theorem Proving in High-Quality Software Design

    Science.gov (United States)

    Schumann, Johann; Swanson, Keith (Technical Monitor)

    2001-01-01

    The amount and complexity of software developed during the last few years has increased tremendously. In particular, programs are being used more and more in embedded systems (from car-brakes to plant-control). Many of these applications are safety-relevant, i.e. a malfunction of hardware or software can cause severe damage or loss. Tremendous risks are typically present in the area of aviation, (nuclear) power plants or (chemical) plant control. Here, even small problems can lead to thousands of casualties and huge financial losses. Large financial risks also exist when computer systems are used in the area of telecommunication (telephone, electronic commerce) or space exploration. Computer applications in this area are not only subject to safety considerations, but also security issues are important. All these systems must be designed and developed to guarantee high quality with respect to safety and security. Even in an industrial setting which is (or at least should be) aware of the high requirements in Software Engineering, many incidents occur. For example, the Warshaw Airbus crash, was caused by an incomplete requirements specification. Uncontrolled reuse of an Ariane 4 software module was the reason for the Ariane 5 disaster. Some recent incidents in the telecommunication area, like illegal "cloning" of smart-cards of D2GSM handies, or the extraction of (secret) passwords from German T-online users show that also in this area serious flaws can happen. Due to the inherent complexity of computer systems, most authors claim that only a rigorous application of formal methods in all stages of the software life cycle can ensure high quality of the software and lead to real safe and secure systems. In this paper, we will have a look, in how far automated theorem proving can contribute to a more widespread application of formal methods and their tools, and what automated theorem provers (ATPs) must provide in order to be useful.

  18. Frequency of chromosomal aneuploidy in high quality embryos from young couples using preimplantation genetic screening

    Directory of Open Access Journals (Sweden)

    Farzaneh Fesahat

    2017-09-01

    Full Text Available Background: Selection of the best embryo for transfer is very important in assisted reproductive technology (ART. Using morphological assessment for this selection demonstrated that the correlation between embryo morphology and implantation potential is relatively weak. On the other hand, aneuploidy is a key genetic factor that can influence human reproductive success in ART. Objective: The aim of this lab trial study was to evaluate the incidence of aneuploidies in five chromosomes in the morphologically high-quality embryos from young patients undergoing ART for sex selection. Materials and Methods: A total of 97 high quality embryos from 23 women at the age of 37or younger years that had previously undergone preimplantation genetic screening for sex selection were included in this study. After washing, the slides of blastomeres from embryos of patients were reanalyzed by fluorescence in-situ hybridization for chromosomes 13, 18 and 21. Results: There was a significant rate of aneuploidy determination in the embryos using preimplantation genetic screening for both sex and three evaluated autosomal chromosomes compared to preimplantation genetic screening for only sex chromosomes (62.9% vs. 24.7%, p=0.000. The most frequent detected chromosomal aneuploidy was trisomy or monosomy of chromosome 13. Conclusion: There is considerable numbers of chromosomal abnormalities in embryos generated in vitro which cause in vitro fertilization failure and it seems that morphological characterization of embryos is not a suitable method for choosing the embryos without these abnormalities

  19. Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ahmed, Sara; Bartlett, Susan J; Ernst, Pierre; Paré, Guy; Kanter, Maria; Perreault, Robert; Grad, Roland; Taylor, Laurel; Tamblyn, Robyn

    2011-12-14

    Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to

  20. Recruiting and retaining high-quality teachers in rural areas.

    Science.gov (United States)

    Monk, David H

    2007-01-01

    In examining recruitment and retention of teachers in rural areas, David Monk begins by noting the numerous possible characteristics of rural communities--small size, sparse settlement, distance from population concentrations, and an economic reliance on agricultural industries that are increasingly using seasonal and immigrant workers to minimize labor costs. Many, though not all, rural areas, he says, are seriously impoverished. Classes in rural schools are relatively small, and teachers tend to report satisfaction with their work environments and relatively few problems with discipline. But teacher turnover is often high, and hiring can be difficult. Monk observes that rural schools have a below-average share of highly trained teachers. Compensation in rural schools tends to be low, perhaps because of a lower fiscal capacity in rural areas, thus complicating efforts to attract and retain teachers. Several student characteristics, including relatively large shares of students with special needs and with limited English skills and lower shares of students attending college, can also make it difficult to recruit and retain high-quality teachers. Other challenges include meeting the needs of highly mobile children of low-income migrant farm workers. With respect to public policy, Monk asserts a need to focus on a subcategory of what might be called hard-to-staff rural schools rather than to develop a blanket set of policies for all rural schools. In particular, he recommends a focus on such indicators as low teacher qualifications, teaching in fields far removed from the area of training, difficulty in hiring, high turnover, a lack of diversity among teachers in the school, and the presence of migrant farm workers' children. Successful efforts to stimulate economic growth in these areas would be highly beneficial. He also calls attention to the potential for modern telecommunication and computing technologies to offset some of the drawbacks associated with teaching

  1. Randomised controlled trial of the effectiveness of using foot reflexology to improve quality of sleep amongst Taiwanese postpartum women.

    Science.gov (United States)

    Li, Chia-Yen; Chen, Su-Chiu; Li, Chung-Yi; Gau, Meei-Ling; Huang, Chiu-Mieh

    2011-04-01

    to examine the effectiveness of using foot reflexology to improve sleep quality in postpartum women. randomised controlled trial, conducted at two postpartum centres in northern Taiwan. 65 postpartum women reporting poor quality of sleep were recruited from July 2007 to December 2007. participants were assigned randomly to either an intervention or a control group. Participants in both groups received the same care except for reflexology therapy. The intervention group received a single 30-minute foot reflexology session at the same time each evening for five consecutive days. Sessions were administered by a certified nurse reflexologist. MEASURES AND FINDINGS: the outcome measure was the Pittsburgh sleep quality index (PSQI), and this was performed at baseline and post test. Mean PQSI scores for both groups declined over time between baseline and post test. Using a generalised estimation equation to control several confounding variables, the changes in mean PSQI were found to be significantly lower in the intervention group (β=-2.24, standard error=0.38, pfoot reflexology in the postnatal period significantly improved the quality of sleep. midwives should evaluate maternal sleep quality and design early intervention programmes to improve quality of sleep in order to increase maternal biopsychosocial well-being. Midwives interested in complementary therapies should be encouraged to obtain training in reflexology and to apply it in clinical settings if it is allowed. Copyright © 2009 Elsevier Ltd. All rights reserved.

  2. Redesigning Radiotherapy Quality Assurance: Opportunities to Develop an Efficient, Evidence-Based System to Support Clinical Trials-Report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance

    Energy Technology Data Exchange (ETDEWEB)

    Bekelman, Justin E., E-mail: bekelman@uphs.upenn.edu [University of Pennsylvania, Philadelphia, Pennsylvania (United States); Deye, James A.; Vikram, Bhadrasain [National Cancer Institute, Bethesda, Maryland (United States); Bentzen, Soren M. [University of Wisconsin, Madison, Wisconsin (United States); Bruner, Deborah [University of Pennsylvania, Philadelphia, Pennsylvania (United States); Curran, Walter J. [Emory University, Atlanta, Georgia (United States); Dignam, James [University of Chicago, Chicago, Illinois (United States); Efstathiou, Jason A. [Massachusetts General Hospital, Boston, Massachusetts (United States); FitzGerald, T.J. [University of Massachusetts, Boston, Massachusetts (United States); Hurkmans, Coen [European Organization for Research and Treatment of Cancer, Brussels (Belgium); Ibbott, Geoffrey S.; Lee, J. Jack [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Merchant, Thomas E. [St. Jude Children' s Research Hospital, Memphis, Tennessee (United States); Michalski, Jeff [University of Washington, St. Louis, Missouri (United States); Palta, Jatinder R. [University of Florida, Miami, Florida (United States); Simon, Richard [National Institutes of Health, Bethesda, Maryland (United States); Ten Haken, Randal K. [University of Michigan, Ann Arbor, Michigan (United States); Timmerman, Robert [University of Texas Southwestern Medical Center, Dallas, Texas (United States); Tunis, Sean [Center for Medical Technology Policy, Baltimore, Maryland (United States); Coleman, C. Norman [National Cancer Institute, Bethesda, Maryland (United States); and others

    2012-07-01

    Purpose: In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute sponsored a 2-day workshop to examine challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods and Materials: Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. The lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities such as proton beam therapy, and the international harmonization of clinical trial QA. Results: Four recommendations were made: (1) to develop a tiered (and more efficient) system for radiotherapy QA and tailor the intensity of QA to the clinical trial objectives (tiers include general credentialing, trial-specific credentialing, and individual case review); (2) to establish a case QA repository; (3) to develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and (4) to explore the feasibility of consolidating clinical trial QA in the United States. Conclusion: Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based.

  3. Complementary religious and spiritual interventions in physical health and quality of life: A systematic review of randomized controlled clinical trials.

    Directory of Open Access Journals (Sweden)

    Juliane Piasseschi de Bernardin Gonçalves

    Full Text Available To examine whether religious and spiritual interventions (RSIs can promote physical health and quality of life in individuals.The following databases were used to conduct a systematic review: PubMed, Scopus, Web of Science, EMBASE, PsycINFO, Cochrane, and Scielo. Randomized controlled trials that evaluated RSIs regarding physical health outcomes and/or quality of life in English, Spanish or Portuguese were included. RSI protocols performed at a distance (i.e. intercessory prayer or for psychiatric disorders were excluded. This study consisted of two phases: (a reading titles and abstracts, and (b assessing the full articles and their methodological quality using the Cochrane Back Review Group scale.In total, 7,070 articles were identified in the search, but 6884 were excluded in phase 1 because they were off topic or repeated in databases. Among the 186 articles included in phase 2, 140 were excluded because they did not fit the inclusion criteria and 16 did not have adequate randomization process. Thus, a final selection of 30 articles remained. The participants of the selected studies were classified in three groups: chronic patients (e.g., cancer, obesity, pain, healthy individuals and healthcare professionals. The outcomes assessed included quality of life, physical activity, pain, cardiac outcomes, promotion of health behaviors, clinical practice of healthcare professionals and satisfaction with protocols. The divergence concerning scales and protocols proposed did not allow a meta-analysis. RSIs as a psychotherapy approach were performed in 40% of the studies, and the control group was more likely to use an educational intervention (56.7%. The results revealed small effect sizes favoring RSIs in quality of life and pain outcomes and very small effects sizes in physical activity, promotion of health behaviors and clinical practice of health professionals compared with other complementary strategies. Other outcomes, such as cardiac measures

  4. Routine quality control of high dose rate brachytherapy equipment

    International Nuclear Information System (INIS)

    Guzman Calcina, Carmen S.; Almeida, Adelaide de; Rocha, Jose R. Oliveira

    2001-01-01

    A Quality Assurance program should be installed also for High Dose Rate brachytherapy, in the order to achieve a correct dose administration to the patient and for the safety to those involved directly with the treatment. The work presented here has the following purposes: Analyze the types of equipment tests presented by the official protocols (TG40, TG56 e ARCAL XXX), evaluate the brachytherapy routine tests of protocols from various national and international radiotherapy services and compare the latter with those presented in the official protocols. As a result, we conclude the following: TG56 presents a higher number of tests when compared to the other official protocols and most of the tests presented by the analyzed services are present in TG56. A suggestion for a basic protocol is presented, emphasizing the periodicity and tolerance level of each of the tests. (author)

  5. High quality diesel fuels by VO-LSGO hydrotreatment

    Energy Technology Data Exchange (ETDEWEB)

    Stanica-Ezeanu, Dorin; Juganaru, Traian [Petroleum and Gas Univ. of Ploiesti (Romania)

    2013-06-01

    The aim of the paper is to obtain a high quality Diesel fuel by hydro-deoxigenation of vegetable oils (VO) mixed with a low sulfur gasoil (LSGO). The process is possible by using a bi-functional catalyst Ni-Mo supported by an activated Al{sub 2}O{sub 3} containing 2% Ultrastable Y-zeolite. The experimental conditions were: T =340 - 380 C, Pressure = 50 bar, LHSV = 1,5 h{sup -1}, H{sub 2}/Feed ratio = 15 mole H{sub 2} /mole liquid feed. The liquid product was separated in two fractions: a light distillate (similar to gasoline) and a heavy distillate (boiling point > 200 C) with very good characteristics for Diesel engines. The reaction chemistry is very complex, but the de-oxygenation process is decisive for the chemical structure of hydrocarbons from final product. Finally, a schema for the reaction mechanism is proposed. (orig.)

  6. Supercapacitors based on high-quality graphene scrolls

    Science.gov (United States)

    Zeng, Fanyan; Kuang, Yafei; Liu, Gaoqin; Liu, Rui; Huang, Zhongyuan; Fu, Chaopeng; Zhou, Haihui

    2012-06-01

    High-quality graphene scrolls (GSS) with a unique scrolled topography are designed using a microexplosion method. Their capacitance properties are investigated by cyclic voltammetry, galvanostatic charge-discharge and electrical impedance spectroscopy. Compared with the specific capacity of 110 F g-1 for graphene sheets, a remarkable capacity of 162.2 F g-1 is obtained at the current density of 1.0 A g-1 in 6 M KOH aqueous solution owing to the unique scrolled structure of GSS. The capacity value is increased by about 50% only because of the topological change of graphene sheets. Meanwhile, GSS exhibit excellent long-term cycling stability along with 96.8% retained after 1000 cycles at 1.0 A g-1. These encouraging results indicate that GSS based on the topological structure of graphene sheets are a kind of promising material for supercapacitors.

  7. A roadmap to high quality chemically prepared graphene

    Energy Technology Data Exchange (ETDEWEB)

    Gengler, Regis Y N; Spyrou, Konstantinos; Rudolf, Petra, E-mail: r.gengler@rug.n, E-mail: p.rudolf@rug.n [Zernike Institute for Advanced Materials, University of Groningen, Nijenborgh 4, 9747AG Groningen (Netherlands)

    2010-09-22

    Graphene was discovered half a decade ago and proved the existence of a two-dimensional system which becomes stable as a result of 3D corrugation. It appeared very quickly that this exceptional material had truly outstanding electronic, mechanical, thermal and optical properties. Consequently a broad range of applications appeared, as the graphene science speedily moved forward. Since then, a lot of effort has been devoted not only to the study of graphene but also to its fabrication. Here we review the chemical approaches to graphene production, their advantages as well as their downsides. Our aim is to draw a roadmap of today's most reliable path to high quality graphene via chemical preparation.

  8. High quality factor HTS Josephson junctions on low loss substrates

    Energy Technology Data Exchange (ETDEWEB)

    Stornaiuolo, D; Longobardi, L; Massarotti, D; Barone, A; Tafuri, F [CNR-SPIN Napoli, Complesso Universitario di Monte Sant' Angelo, via Cinthia, 80126 Napoli (Italy); Papari, G; Carillo, F [NEST, CNR-NANO and Scuola Normale Superiore, Piazza San Silvestro 12, 56127 Pisa (Italy); Cennamo, N [Dipartimento Ingegneria dell' Informazione, Seconda Universita degli Studi di Napoli, via Roma 29, 81031 Aversa (Italy)

    2011-04-15

    We have extended the off-axis biepitaxial technique to produce YBCO grain boundary junctions on low loss substrates. Excellent transport properties have been reproducibly found, with remarkable values of the quality factor I{sub c}R{sub n} (with I{sub c} the critical current and R{sub n} the normal state resistance) above 10 mV, far higher than the values commonly reported in the literature for high temperature superconductor (HTS) based Josephson junctions. The outcomes are consistent with a picture of a more uniform grain boundary region along the current path. This work supports a possible implementation of grain boundary junctions for various applications including terahertz sensors and HTS quantum circuits in the presence of microwaves.

  9. A roadmap to high quality chemically prepared graphene

    International Nuclear Information System (INIS)

    Gengler, Regis Y N; Spyrou, Konstantinos; Rudolf, Petra

    2010-01-01

    Graphene was discovered half a decade ago and proved the existence of a two-dimensional system which becomes stable as a result of 3D corrugation. It appeared very quickly that this exceptional material had truly outstanding electronic, mechanical, thermal and optical properties. Consequently a broad range of applications appeared, as the graphene science speedily moved forward. Since then, a lot of effort has been devoted not only to the study of graphene but also to its fabrication. Here we review the chemical approaches to graphene production, their advantages as well as their downsides. Our aim is to draw a roadmap of today's most reliable path to high quality graphene via chemical preparation.

  10. CHOREOGRAPHIC METHODS FOR CREATING NOVEL, HIGH QUALITY DANCE

    Directory of Open Access Journals (Sweden)

    David Kirsh

    2016-02-01

    Full Text Available We undertook a detailed ethnographic study of the dance creation process of a noted choreographer and his distinguished troupe. All choreographer dancer interactions were videoed, the choreographer and dancers were interviewed extensively each day, as well as other observations and tests performed. The choreographer used three main methods to produce high quality and novel content: showing, making-on, and tasking. We present, analyze and evaluate these methods, and show how these approaches allow the choreographer to increase the creative output of the dancers and him. His methods, although designed for dance, apply more generally to other creative endeavors, especially where brainstorming is involved, and where the creative process is distributed over many individuals. His approach is also a case study in multi-modal direction, owing to the range of mechanisms he uses to communicate and direct.

  11. Biotransformation of Organic Waste into High Quality Fertilizer

    DEFF Research Database (Denmark)

    Bryndum, Sofie

    Agriculture faces several challenges of future provision of nutrients such as limited P reserves and increasing prices of synthetic fertilizers and recycling of nutrients from organic waste can be an important strategy for the long-term sustainability of the agricultural systems. Organically...... and S, is often low; and (3) the unbalanced composition of nutrients rarely matches crop demands. Therefore the objective of this project was to investigate the potential for (1) recycling nutrients from agro-industrial wastes and (2) compost biotransformation into high-quality organic fertilizers...... other uses into fertilizer use would be unlikely. An estimated ~50 % of the total organic waste pool, primarily consisting of animal manure and waste from the processing of sugar cane, coffee, oil palm and oranges, is currently being re-used as “fertilizers”, meaning it is eventually returned...

  12. New product trial, use of edibles, and unexpected highs among marijuana and hashish users in Colorado.

    Science.gov (United States)

    Allen, Jane A; Davis, Kevin C; Duke, Jennifer C; Nonnemaker, James M; Bradfield, Brian R; Farrelly, Matthew C

    2017-07-01

    This study examines the relationships between trial of new marijuana or hashish products and unexpected highs, and use of edible products and unexpected highs. We conducted an online survey of 634 adult, past-year marijuana users in Colorado. We used logistic regression models to examine the relationship between new product trial or edible use and unexpected highs. In the first year that recreational marijuana was legal in Colorado, 71.4% of respondents tried a new marijuana or hashish product, and 53.6% used an edible product. Trial of new products was associated with greater odds of experiencing an unexpected high after controlling for age, gender, education, mental health status, current marijuana or hashish use, and mean amount of marijuana or hashish consumed in the past month (OR=2.13, pmarijuana or hashish products, or use edible marijuana or hashish products, are at greater risk for an unexpected high. It is possible that some negative outcomes associated with marijuana use and unexpected highs may be averted through a better understanding of how to use product packaging to communicate with consumers. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. [The impact of researchers loyal to Big Pharma on the ethics and quality of clinical trials in Latin America].

    Science.gov (United States)

    Ugalde, Antonio; Homedes, Núria

    2015-03-01

    This article explains the difficulties innovative pharmaceutical firms have in repaying shareholders with attractive dividends. The problem is the result of the expiration of the patents of blockbuster drugs and the difficulties that the firms have in bringing new blockbuster drugs to the market. One of the solutions companies have found has been to accelerate the implementation of clinical trials in order to expedite the commercialization of new drugs. Doing so increases the period in which they can sell drugs at monopoly prices. We therefore discuss how innovative pharmaceutical firms shorten the implementation time of clinical trials in Latin America and the consequences such actions have on the quality of the collected data, the protection of human rights of the subjects of experimentation, and compliance with the ethical principles approved in international declarations.

  14. Exercise and health-related quality of life during the first year following acute stroke. A randomized controlled trial.

    Science.gov (United States)

    Langhammer, Birgitta; Stanghelle, Johan K; Lindmark, Birgitta

    2008-02-01

    To evaluate the impact of two different physiotherapy exercise regimes in patients after acute stroke on health-related quality of life (HRQoL) and to investigate how the degree of motor and balance function, gait capacity, activities of daily living and instrumental activities of daily living influenced HRQoL. A longitudinal randomized controlled stratified trial of two interventions: the intensive exercise groups with scheduled intensive training during four periods of the first year after stroke and the regular exercise group with self-initiated training. There was a tendency of better HRQoL in the regular exercise group on NHP total score (p = 0.05). Patients with low scores in activities of daily living, balance and motor function and inability to perform 6-minute walk test on admission, scored lower on self-perceived health than patients with high scores and ability to perform the walking test. At 1 year post-stroke, total scores on NHP were moderately associated with motor function (r = -0.63), balance (r = -0.56), gait (r = -0.57), activities of daily living (r = -0.57) and instrumental activities of daily living (r = -0.49-0.58). The physical mobility sub-scale of NHP had the strongest association ranging from r = -0.47-0.82. The regular exercise group with self-initiated training seemed to enhance HRQoL more than the intensive exercise group with scheduled intensive training. The degree of motor function, balance, walking capacity and independence in activities of daily living is of importance for perceived HRQoL.

  15. Intraoperative Nerve Blocks Fail to Improve Quality of Recovery after Tissue Expander Breast Reconstruction: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Lanier, Steven T; Lewis, Kevin C; Kendall, Mark C; Vieira, Brittany L; De Oliveira, Gildasio; Nader, Anthony; Kim, John Y S; Alghoul, Mohammed

    2018-03-01

    The authors' study represents the first level I evidence to assess whether intraoperative nerve blocks improve the quality of recovery from immediate tissue expander/implant breast reconstruction. A prospective, randomized, double-blinded, placebo-controlled clinical trial was conducted in which patients undergoing immediate tissue expander/implant breast reconstruction were randomized to either (1) intraoperative intercostal and pectoral nerve blocks with 0.25% bupivacaine with 1:200,000 epinephrine and 4 mg of dexamethasone or (2) sham nerve blocks with normal saline. The 40-item Quality of Recovery score, pain score, and opioid use in the postoperative period were compared statistically between groups. Power analysis ensured 80 percent power to detect a 10-point (clinically significant) difference in the 40-item Quality of Recovery score. Forty-seven patients were enrolled. Age, body mass index, laterality, mastectomy type, and lymph node dissection were similar between groups. There were no statistical differences in quality of recovery, pain burden as measured by visual analogue scale, opioid consumption, antiemetic use, or length of hospital stay between groups at 24 hours after surgery. Mean global 40-item Quality of Recovery scores were 169 (range, 155 to 182) for the treatment arm and 165 (range, 143 to 179) for the placebo arm (p = 0.36), indicating a high quality of recovery in both groups. Although intraoperative nerve blocks can be a safe adjunct to a comprehensive postsurgical recovery regimen, the authors' results indicate no effect on overall quality of recovery from tissue expander/implant breast reconstruction. Therapeutic, I.

  16. Questionnaire based quality assurance for the RT01 trial of dose escalation in conformal radiotherapy for prostate cancer (ISRCTN 47772397)

    International Nuclear Information System (INIS)

    Mayles, W.; Moore, A.Rollo; Aird, Edwin G.A.; Bidmead, A. Margaret; Dearnaley, David P.; Griffiths, Sue E.; Stephens, Richard J.; Warrington, A.P. Jim

    2004-01-01

    Background and purpose: In order to ensure the validity of the outcome of the Medical Research Council's 'RT01 trial' of dose escalation in conformal radiotherapy for prostate cancer it was considered important that the quality of treatment delivery should meet an adequate standard across all contributing centres. A questionnaire was therefore devised to ensure that all aspects of the planning and delivery process were adequately covered. Patients and methods: The questionnaire considered each step in the planning and delivery process and drew the attention of the participants to the specific requirements of the trial. Before entering patients into the trial each participating centre had to complete the questionnaire and an outlining exercise (reported elsewhere). Results: It was not practicable to define a detailed universally acceptable protocol for the whole process of delivery of conformal radiotherapy, not least because of the different equipment available for planning and treatment in different centres. The questionnaire identified some areas of difference in practice between centres where there may be a need for the development of a consensus as to best practice, particularly in the area of patient set-up. Occasionally it was necessary to follow up responses to questions that had been misunderstood or inadequately answered, but in most cases these issues proved to be easily resolved. Conclusions: The questionnaire proved to be a useful self-assessment tool as well as enabling the quality assurance group to ensure that the standards of the trial were being met. Subsequent follow-up visits confirmed the usefulness and validity of this self assessment process

  17. Reporting quality of conference abstracts on randomised controlled trials in gerontology and geriatrics: a cross-sectional investigation.

    Science.gov (United States)

    Mann, Eva; Meyer, Gabriele

    2011-01-01

    Without transparent reporting of how a randomised controlled trial was designed and conducted and of the methods used, its internal validity cannot be assessed by the reader. A congress abstract is often the only source providing information about a trial. In January 2008, an extended CONSORT statement on abstract reporting was published. Its impact has yet to be evaluated. Using a slightly modified CONSORT checklist comprising 17 items, we thus investigated the reporting quality of randomised controlled trials published in the book of abstracts presented at the World Congress of Geriatrics and Gerontology in Paris in July 2009. A total of n=4,416 abstracts was screened for inclusion; n=129 met the inclusion criteria. The overall quality of the abstracts was remarkably poor. The primary outcome was mentioned in 34/129 abstracts (26%), none of the abstracts reported on the procedure of random allocation of participants or clusters, 21/129 abstracts (16%) reported some kind of blinding, and the attrition rate was mentioned in only 12/129 abstracts (9%). The majority of abstracts fulfilled two items: description of intended intervention for each group (102/129; 79%) and general interpretation of results (107/129; 83%). Trial status was reported in all abstracts. Both journal editors and committees organising congresses are requested to define the use of the CONSORT statement as a prerequisite in their guidelines for authors and to instruct reviewers to conduct compliance checks. Medical associations should finally endorse the indispensability of the CONSORT statement and publish it in their journals. Otherwise the intended benefits cannot be fully generated. Copyright © 2010. Published by Elsevier GmbH.

  18. Efficacy of omeprazole on cough, pulmonary function and quality of life of patients with sulfur mustard lung injury: A placebo-control, cross-over clinical trial study

    Directory of Open Access Journals (Sweden)

    Mohammad Hossein Emami

    2014-01-01

    Full Text Available Background: Gastro-esophageal reflux disease (GERD is prevalent and related to more severe disease in patients with respiratory problems. We evaluated the effects of antireflux therapy in warfare victims of exposure to Mustard gas with chronic cough. Materials and Methods: This randomized, double-blind, placebo-controlled, cross-over study was conducted on 45 cases of sulfur mustard injury with chronic cough (≥8 weeks and GERD. Patients were randomized into two groups, receiving either 20 mg twice daily omeprazole-placebo (OP or matching placebo (placebo-omeprazole [PO] for 4 months, followed by a 1-month washout period and the alternative treatment for 4 months. Assessments included GERD and cough, quality of life, and pulmonary function using spirometry. Leicester Cough Questionnaire and SF-36 were used for measuring quality of life. Results: Patients in the OP group experienced a more decrease than those in the PO group in severity of Leicester cough scores during the first 4-month of trial. After crossing the groups, the OP group experienced an increase (P = 0.036 and the PO group experienced a nonsignificant decrease (P = 0.104 in the severity of scores. The OP group also experienced improvement in GERD symptoms and quality of life at the end of the trial, but changes in the PO group was not significant. There was no significant change in respiratory function indices in any groups. Conclusion: Long-term treatment with high-dose omeprazole improved GERD as well as cough, and quality of life, but not changed respiratory function indices in sulfur mustard injured cases with respiratory symptoms.

  19. Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

    Science.gov (United States)

    Yang, Chiu-Ling; Chen, Chung-Hey

    2018-01-01

    Gymnastics is a preferable safe exercise for postnatal women performing regularly. The aim of this pilot randomized controlled trial was to determine whether the aerobic gymnastic exercise improves stress, fatigue, sleep quality and depression in postpartum women. Single-blinded, randomized controlled trial held from December 2014 until September 2015. Postnatal clinic of a medical center in southern Taiwan. 140 eligible postnatal women were systematically assigned, with a random start to experimental (n=70) or a control (n=70) group. Engage in aerobic gymnastic exercise at least three times (15min per section) a week for three months using compact disc in the home. Perceived Stress Scale, Postpartum Fatigue Scale, Postpartum Sleep Quality Scale, and Edinburgh Postnatal Depression Scale. In a two-way ANOVA with repeated measures, the aerobic gymnastic exercise group showed significant decrease in fatigue after practicing exercise 4 weeks and the positive effects extended to the 12-week posttests. Paired t-tests revealed that aerobic gymnastic exercise participants had improved significantly in perceived stress and fatigue after 4 weeks gymnastic exercise; these positive effects extended to the 12-week posttests. In addition, the changes in physical symptoms-related sleep inefficiency after 12 weeks gymnastic exercise were significantly decreased in the experimental group compared with the control group. The findings can be used to encourage postnatal women to perform moderate-intensity gymnastic exercise in their daily life to reduce their stress, fatigue and improve sleep quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Pretreatment data is highly predictive of liver chemistry signals in clinical trials.

    Science.gov (United States)

    Cai, Zhaohui; Bresell, Anders; Steinberg, Mark H; Silberg, Debra G; Furlong, Stephen T

    2012-01-01

    The goal of this retrospective analysis was to assess how well predictive models could determine which patients would develop liver chemistry signals during clinical trials based on their pretreatment (baseline) information. Based on data from 24 late-stage clinical trials, classification models were developed to predict liver chemistry outcomes using baseline information, which included demographics, medical history, concomitant medications, and baseline laboratory results. Predictive models using baseline data predicted which patients would develop liver signals during the trials with average validation accuracy around 80%. Baseline levels of individual liver chemistry tests were most important for predicting their own elevations during the trials. High bilirubin levels at baseline were not uncommon and were associated with a high risk of developing biochemical Hy's law cases. Baseline γ-glutamyltransferase (GGT) level appeared to have some predictive value, but did not increase predictability beyond using established liver chemistry tests. It is possible to predict which patients are at a higher risk of developing liver chemistry signals using pretreatment (baseline) data. Derived knowledge from such predictions may allow proactive and targeted risk management, and the type of analysis described here could help determine whether new biomarkers offer improved performance over established ones.

  1. Strengthening exercises improve symptoms and quality of life but do not change autonomic modulation in fibromyalgia: a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Maria Bernadete Renoldi Oliveira Gavi

    Full Text Available OBJECTIVE: Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia (FM. Exercise is an effective treatment, with benefits potentially mediated through changes in autonomic modulation. Strengthening is one of the less studied exercises in FM, and the acute and chronic effects of strengthening on the autonomic system remain unknown. The objective of this study was to assess the chronic effects of strengthening exercises (STRE on autonomic modulation, pain perception and the quality of life (QOL of FM patients. METHODS: Eighty sedentary women with FM (ACR 1990 were randomly selected to participate in STRE or flexibility (FLEX exercises in a blinded controlled trial. The intensity of STRE was set at 45% of the estimated load of 1 Repetition Maximum (RM in 12 different exercises. Outcomes were Visual Analog Scale (VAS for pain, Heart Rate Variability (HRV analysis, treadmill test, the sit and reach test (Wells and Dillon's Bench, maximal repetitions test and handgrip dynamometry; and quality of life by the Fibromyalgia Impact Questionnaire (FIQ, the Beck and Idate Trait-State Inventory (IDATE, a short-form health survey (SF-36. RESULTS: The STRE group was more effective to strength gain for all muscles and pain control after 4 and 16 weeks (p<0.05. The FLEX group showed higher improvements in anxiety (p<0.05. Both groups showed improvements in the QOL, and there was no significant difference observed between the groups. There was no change in the HRV of the STRE and FLEX groups. CONCLUSIONS: Strengthening exercises show greater and more rapid improvements in pain and strength than flexibility exercises. Despite the benefits in fitness, pain, depression, anxiety and quality of life, no effect was observed on the autonomic modulation in both groups. This observation suggests that changes in autonomic modulation are not a target tobe clinically achieved in fibromyalgia. TRIAL REGISTRATION: ClinicalTrials

  2. Process evaluation of the Data-driven Quality Improvement in Primary Care (DQIP) trial: quantitative examination of variation between practices in recruitment, implementation and effectiveness.

    Science.gov (United States)

    Dreischulte, Tobias; Grant, Aileen; Hapca, Adrian; Guthrie, Bruce

    2018-01-05

    The cluster randomised trial of the Data-driven Quality Improvement in Primary Care (DQIP) intervention showed that education, informatics and financial incentives for general medical practices to review patients with ongoing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets reduced the primary end point of high-risk prescribing by 37%, where both ongoing and new high-risk prescribing were significantly reduced. This quantitative process evaluation examined practice factors associated with (1) participation in the DQIP trial, (2) review activity (extent and nature of documented reviews) and (3) practice level effectiveness (relative reductions in the primary end point). Invited practices recruited (n=33) and not recruited (n=32) to the DQIP trial in Scotland, UK. (1) Characteristics of recruited versus non-recruited practices. Associations of (2) practice characteristics and 'adoption' (self-reported implementation work done by practices) with documented review activity and (3) of practice characteristics, DQIP adoption and review activity with effectiveness. (1) Recruited practices had lower performance in the quality and outcomes framework than those declining participation. (2) Not being an approved general practitioner training practice and higher self-reported adoption were significantly associated with higher review activity. (3) Effectiveness ranged from a relative increase in high-risk prescribing of 24.1% to a relative reduction of 77.2%. High-risk prescribing and DQIP adoption (but not documented review activity) were significantly associated with greater effectiveness in the final multivariate model, explaining 64.0% of variation in effectiveness. Intervention implementation and effectiveness of the DQIP intervention varied substantially between practices. Although the DQIP intervention primarily targeted review of ongoing high-risk prescribing, the finding that self-reported DQIP adoption was a stronger predictor of

  3. High quality protein microarray using in situ protein purification

    Directory of Open Access Journals (Sweden)

    Fleischmann Robert D

    2009-08-01

    Full Text Available Abstract Background In the postgenomic era, high throughput protein expression and protein microarray technologies have progressed markedly permitting screening of therapeutic reagents and discovery of novel protein functions. Hexa-histidine is one of the most commonly used fusion tags for protein expression due to its small size and convenient purification via immobilized metal ion affinity chromatography (IMAC. This purification process has been adapted to the protein microarray format, but the quality of in situ His-tagged protein purification on slides has not been systematically evaluated. We established methods to determine the level of purification of such proteins on metal chelate-modified slide surfaces. Optimized in situ purification of His-tagged recombinant proteins has the potential to become the new gold standard for cost-effective generation of high-quality and high-density protein microarrays. Results Two slide surfaces were examined, chelated Cu2+ slides suspended on a polyethylene glycol (PEG coating and chelated Ni2+ slides immobilized on a support without PEG coating. Using PEG-coated chelated Cu2+ slides, consistently higher purities of recombinant proteins were measured. An optimized wash buffer (PBST composed of 10 mM phosphate buffer, 2.7 mM KCl, 140 mM NaCl and 0.05% Tween 20, pH 7.4, further improved protein purity levels. Using Escherichia coli cell lysates expressing 90 recombinant Streptococcus pneumoniae proteins, 73 proteins were successfully immobilized, and 66 proteins were in situ purified with greater than 90% purity. We identified several antigens among the in situ-purified proteins via assays with anti-S. pneumoniae rabbit antibodies and a human patient antiserum, as a demonstration project of large scale microarray-based immunoproteomics profiling. The methodology is compatible with higher throughput formats of in vivo protein expression, eliminates the need for resin-based purification and circumvents

  4. Air-insufflated high-definition dacryoendoscopy yields significantly better image quality than conventional dacryoendoscopy

    Directory of Open Access Journals (Sweden)

    Sasaki T

    2017-08-01

    Full Text Available Tsugihisa Sasaki,1 Tsutomu Sounou,2 Hideki Tsuji,3 Kazuhisa Sugiyama4 1Sasaki Eye Clinic, Mikuni, Sakai, 2Department of Ophthalmology, Keiju Kanazawa Hospital, 3Department of Ophthalmology, Cancer Institute Hospital, 4Department of Ophthalmology and Visual Science, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan Purpose: To facilitate the analysis of lacrimal conditions, we utilized high-definition dacryoendoscopy (HDD and undertook observations with a pressure-controlled air-insufflation system. We report the safety and performance of HDD.Methods: In this retrospective, non-randomized clinical trial, 46 patients (14 males and 32 females; age range 39–91 years; mean age ± SD 70.3±12.0 years who had lacrimal disorders were examined with HDD and conventional dacryoendoscopy (CD. The high-definition dacryoendoscope had 15,000 picture element image fibers and an advanced objective lens. Its outer diameter was 0.9–1.2 mm. Air insufflation was controlled at 0–20 kPa with a digital manometer-based pressure-controlled air-insufflation system to evaluate the quality of the image. The HDD had an air/saline irrigation channel between the outer sheath (outer diameter =1.2 mm and the metal inner sheath of the endoscope. We used it and the CD in air, saline, and diluted milk saline with and without manual irrigation to quantitatively evaluate the effect of air pressure and saline irrigation on image quality.Results: In vivo, the most significant improvement in image quality was demonstrated with air-insufflated (5–15 kPa HDD, as compared with saline-irrigated HDD and saline-irrigated CD. No emphysema or damage was noted under observation with HDD. In vitro, no significant difference was demonstrated between air-insufflated HDD and saline-irrigated HDD. In vitro, the image quality of air-insufflated HDD was significantly improved as compared with that of saline-irrigated CD.Conclusion: Pressure-controlled (5–15 kPa air

  5. The structure of high-quality aluminium cast iron

    Directory of Open Access Journals (Sweden)

    D. Kopyciński

    2012-01-01

    Full Text Available In this study presents the analyse of aluminium iron cast structure (as-cast condition which are used in high temperature. While producing the casts of aluminium iron major influence has been preserve the structure of technological process parameters. The addition to Fe-C-Al alloy V, Ti, Cr leads to the improvement of functional and mechanical cast qualities. In this study, a method was investigated to eliminate the presence of undesirable Al4C3 phases in a aluminium cast iron structure and thus improve the production process. V and Ti additions in aluminium cast iron allows to development of FeAl - VC or TiC alloys. In particular, V or Ti contents above 5 wt.% were found to totally eliminate the presence of Al4C3. In addition, preliminary work indicates that the alloy with the FeAl - VC or TiC structure reveals high oxidation resistance. The introduction of 5 wt.% chromium to aluminium cast iron strengthened Al4C3 precipitate. Thus, the resultant alloy can be considered an intermetallic FeAl matrix strengthened by VC and TiC or modified Al4C3 reinforcements.

  6. High-Quality Seismic Observations of Sonic Booms

    Science.gov (United States)

    Wurman, Gilead; Haering, Edward A., Jr.; Price, Michael J.

    2011-01-01

    The SonicBREWS project (Sonic Boom Resistant Earthquake Warning Systems) is a collaborative effort between Seismic Warning Systems, Inc. and NASA Dryden Flight Research Center. This project aims to evaluate the effects of sonic booms on Earthquake Warning Systems in order to prevent such systems from experiencing false alarms due to sonic booms. The airspace above the Antelope Valley, California includes the High Altitude Supersonic Corridor and the Black Mountain Supersonic Corridor. These corridors are among the few places in the US where supersonic flight is permitted, and sonic booms are commonplace in the Antelope Valley. One result of this project is a rich dataset of high-quality accelerometer records of sonic booms which can shed light on the interaction between these atmospheric phenomena and the solid earth. Nearly 100 sonic booms were recorded with low-noise triaxial MEMS accelerometers recording 1000 samples per second. The sonic booms had peak overpressures ranging up to approximately 10 psf and were recorded in three flight series in 2010 and 2011. Each boom was recorded with up to four accelerometers in various array configurations up to 100 meter baseline lengths, both in the built environment and the free field. All sonic booms were also recorded by nearby microphones. We present the results of the project in terms of the potential for sonic-boom-induced false alarms in Earthquake Warning Systems, and highlight some of the interesting features of the dataset.

  7. Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study.

    Science.gov (United States)

    Gattrell, William T; Hopewell, Sally; Young, Kate; Farrow, Paul; White, Richard; Wager, Elizabeth; Winchester, Christopher C

    2016-02-21

    Authors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs). Cross-sectional study. Primary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123). Proportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined. The number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5-231 days) vs 136 days (IQR 77-193 days)). In this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

  8. Blueprint for action: steps toward a high-quality, high-value maternity care system.

    Science.gov (United States)

    Angood, Peter B; Armstrong, Elizabeth Mitchell; Ashton, Diane; Burstin, Helen; Corry, Maureen P; Delbanco, Suzanne F; Fildes, Barbara; Fox, Daniel M; Gluck, Paul A; Gullo, Sue Leavitt; Howes, Joanne; Jolivet, R Rima; Laube, Douglas W; Lynne, Donna; Main, Elliott; Markus, Anne Rossier; Mayberry, Linda; Mitchell, Lynn V; Ness, Debra L; Nuzum, Rachel; Quinlan, Jeffrey D; Sakala, Carol; Salganicoff, Alina

    2010-01-01

    Childbirth Connection hosted a 90th Anniversary national policy symposium, Transforming Maternity Care: A High Value Proposition, on April 3, 2009, in Washington, DC. Over 100 leaders from across the range of stakeholder perspectives were actively engaged in the symposium work to improve the quality and value of U.S. maternity care through broad system improvement. A multi-disciplinary symposium steering committee guided the strategy from its inception and contributed to every phase of the project. The "Blueprint for Action: Steps Toward a High Quality, High Value Maternity Care System", issued by the Transforming Maternity Care Symposium Steering Committee, answers the fundamental question, "Who needs to do what, to, for, and with whom to improve the quality of maternity care over the next five years?" Five stakeholder workgroups collaborated to propose actionable strategies in 11 critical focus areas for moving expeditiously toward the realization of the long term "2020 Vision for a High Quality, High Value Maternity Care System", also published in this issue. Following the symposium these workgroup reports and recommendations were synthesized into the current blueprint. For each critical focus area, the "Blueprint for Action" presents a brief problem statement, a set of system goals for improvement in that area, and major recommendations with proposed action steps to achieve them. This process created a clear sightline to action that if enacted could improve the structure, process, experiences of care, and outcomes of the maternity care system in ways that when anchored in the culture can indeed transform maternity care. Copyright 2010 Jacobs Institute of Women

  9. Stress and sleep quality in high school brazilian adolescents

    Directory of Open Access Journals (Sweden)

    Gema Mesquita

    2010-06-01

    Full Text Available OBJECTIVE: The objective of the present study is to analyze the effect of stress on sleep quality in a group of adolescents. METHOD: Two high schools in Alfenas, southern Minas Gerais State, Brazil, were chosen to participate in the study. The sample consisted of both genders (n=160 with 65.63% females. The age range of participants was 15 to18 years. The Pittsburgh Sleep Quality Index (PSQI was applied for collection of data to quantify sleep quality. The Lipp Inventory of Stress Symptoms that objectively identifies symptoms of stress was applied. RESULTS: It was observed that 23.53% of stressed students and 45.33% of unstressed ones sleep well; 76.47% of stressed pupils and 54.67% of those unstressed do not sleep well. With regard to school performance, a mean of 0.65 was found for stressed students and 0.60 for those without stress, Mann-Whitney (p=0.0596. CONCLUSION: Stress contributed to raising the percentage of poor sleepers, as ell as increasing ean school performance.OBJETIVO: O objetivo do presente estudo foi analisar a influência do stress sobre a qualidade do sono em um grupo de adolescentes. MÉTODO: Foram escolhidas duas instituições educacionais do ensino médio, na cidade de Alfenas, sul de Minas Gerais, Brasil. A amostra foi composta por ambos os sexos (n=160, com 65,63% do sexo feminino. A faixa etária dos participantes foi de 15 a 18 anos. Para a coleta de dados aplicou-se: Índice de Qualidade de Sono de Pittsburgh (IQSP utilizado para quantificar a qualidade do sono; o Inventário de Sintomas de Stress para Adultos de Lipp (ISSL que identifica de modo objetivo a sintomatologia de stress foi aplicado. RESULTADOS: Observou-se que 23,53% dos estressados dormem bem e 45,33% dos não estressados dormem bem; 76,47% dos estressados não dormem bem e 54,67% dos não estressados não dormem bem. Quanto ao rendimento escolar têm-se as médias 0,65 para os alunos estressados e 0,60 para aqueles que não sofrem de stress, Mann

  10. High-quality endoscope reprocessing decreases endoscope contamination.

    Science.gov (United States)

    Decristoforo, P; Kaltseis, J; Fritz, A; Edlinger, M; Posch, W; Wilflingseder, D; Lass-Flörl, C; Orth-Höller, D

    2018-02-24

    Several outbreaks of severe infections due to contamination of gastrointestinal (GI) endoscopes, mainly duodenoscopes, have been described. The rate of microbial endoscope contamination varies dramatically in literature. The aim of this multicentre prospective study was to evaluate the hygiene quality of endoscopes and automated endoscope reprocessors (AERs) in Tyrol/Austria. In 2015 and 2016, a total of 463 GI endoscopes and 105 AERs from 29 endoscopy centres were analysed by a routine (R) and a combined routine and advanced (CRA) sampling procedure and investigated for microbial contamination by culture-based and molecular-based analyses. The contamination rate of GI endoscopes was 1.3%-4.6% according to the national guideline, suggesting that 1.3-4.6 patients out of 100 could have had contacts with hygiene-relevant microorganisms through an endoscopic intervention. Comparison of R and CRA sampling showed 1.8% of R versus 4.6% of CRA failing the acceptance criteria in phase I and 1.3% of R versus 3.0% of CRA samples failing in phase II. The most commonly identified indicator organism was Pseudomonas spp., mainly Pseudomonas oleovorans. None of the tested viruses were detected in 40 samples. While AERs in phase I failed (n = 9, 17.6%) mainly due to technical faults, phase II revealed lapses (n = 6, 11.5%) only on account of microbial contamination of the last rinsing water, mainly with Pseudomonas spp. In the present study the contamination rate of endoscopes was low compared with results from other European countries, possibly due to the high quality of endoscope reprocessing, drying and storage. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  11. 76 FR 45397 - Export Inspection and Weighing Waiver for High Quality Specialty Grain Transported in Containers

    Science.gov (United States)

    2011-07-29

    ...-AB18 Export Inspection and Weighing Waiver for High Quality Specialty Grain Transported in Containers... permanent a waiver due to expire on July 31, 2012, for high quality specialty grain exported in containers... of high quality specialty grain exported in containers are small entities that up until recently...

  12. How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction).

    Science.gov (United States)

    Bidad, Natalie; MacDonald, Lindsay; Winters, Zoë E; Edwards, Sarah J L; Emson, Marie; Griffin, Clare L; Bliss, Judith; Horne, Rob

    2016-09-02

    Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have been methodologically limited. This study evaluated how women weigh up different motivations after initially expressing altruism, and explored their understanding of a trial and its alternatives. The trial was the 'Quality of Life after Mastectomy and Breast Reconstruction' (QUEST) trial. Thirty-nine women participated in qualitative interviews 1 month post-surgery. Twenty-seven women (10 trial decliners and 17 acceptors) who spontaneously mentioned 'altruism' were selected for thematic analysis. Verbatim transcripts were coded independently by two researchers. Participants' motivations to accept or decline randomisation were cross-referenced with their understanding of the QUEST trials and the process of randomisation. The seven emerging themes were: (1) altruism expressed by acceptors and decliners; (2) overriding personal needs in decliners; (3) pure altruism in acceptors; (4) 'hypothetical altruism' amongst acceptors; (5) weak altruism amongst acceptors; (6) conditional altruism amongst acceptors; and (7) sense of duty to participate. Poor understanding of the trial rationale and its implications was also evident. Altruism was a motivating factor for participation in the QUEST randomised controlled trials where the main outcomes comprised quality of life and allocated treatments comprised established surgical procedures. Women's decisions were influenced by their understanding of the trial. Both acceptors and decliners of the trial expressed 'altruism', but most acceptors lacked an obvious treatment preference, hoped for personal benefits regarding a treatment allocation, or did not articulate complete understanding of the trial. QUEST A, ISRCTN38846532 ; Date assigned 6 January 2010. QUEST B, ISRCTN92581226 ; Date assigned 6 January 2010.

  13. A trial map and GIS class on junior high school with university collaboration in Yokohama, Japan

    Science.gov (United States)

    Tabe, Toshimitsu; Ohnishi, Koji

    2018-05-01

    On the new curriculum of high school in Japan, geography will be compulsory subject in Japan from 2022. The indexes of new high school geography as compulsory subject will be 1. Using of maps and GIS, 2. Understanding of the world and International collaboration: Life and culture, issues of world, 3. Disaster prevention and ESD: natural environment and disaster, and construction of ideal society. The instruction of the GIS will be one of the issues for social studies teachers in the new curriculum. The aim of this study is to make the utilize map and GIS education content through trial class in junior high school. Trial class was done on Tsurugamine junior high school in Yokohama city with university and Yokohama city school board collaboration. In the trial class, the teacher indicated the old and new topographical maps to students and asked them to consider the characteristics of the area and the land use change. Transparent sheets overlaying is useful this activity. Transparent usage indicated the GIS function of overlay. It is good activity for students to understand the function of GIS. After the considering land use changes, they considered the future of their town. The several unused lands are spread in this area. Students present their opinions how to develop them. The important thing to carry out map and GIS class through neighborhood area is preparation of adequate maps. For this preparation, collaboration with university geography stuffs or undergraduate students are effective.

  14. RAndomised controlled trial to imProve depressIon and the quality of life of people with Dementia using cognitive bias modification: RAPID study protocol.

    Science.gov (United States)

    Almeida, Osvaldo P; MacLeod, Colin; Flicker, Leon; Ford, Andrew; Grafton, Ben; Etherton-Beer, Christopher

    2014-07-23

    Depressive symptoms are common and undermine the quality of life of people with Alzheimer's disease (AD). Cholinesterase inhibitors and antidepressants have all but no effect on the mood of patients, and their use increases adverse events. Cognitive bias modification (CBM) targets attentional and interpretative biases associated with anxiety, dysphoria and depression and may be useful to treat depression in AD (DAD). This trial aims to determine the effect of CBM on depression scores and the quality of life of people with DAD. Randomised, double-blind, parallel, controlled trial of CBM (1:1 allocation ratio). Participants will be 80 adults with probable AD living in the Western Australian community who score 8 or more on the Cornell Scale for Depression in Dementia (CSDD). They will have mild to moderate dementia (Mini-Mental State Examination-MMSE score ≥15) and will be free of severe sensory impairment or suicidal intent. The intervention will consist of 10 40 min sessions of CBM delivered over 2 weeks using a high-resolution monitor using a local computer station at the Western Australian Centre for Health and Ageing. The primary outcomes of interest are the 2-week change, from baseline, in the severity of CSDD scores and the Quality of Life AD (QoL-AD) scores. Secondary outcomes include changes in the CSDD, QoL-AD after 12 weeks, and changes in MMSE scores, negative attentional and interpretative bias and the proportion of participants with CSDD principles of the Declaration of Helsinki and participants will provide written informed consent. The Ethics Committee of the Royal Perth Hospital will approve and oversee the study (REG14-036). The results of this trial will provide level 2 evidence of efficacy for CBM as a treatment of DAD. Australian and New Zealand Clinical Trials Registry number ACTRN12614000420640, date registered 06/04/2014. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  15. The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van den Hout Lieke

    2011-11-01

    Full Text Available Abstract Background Congenital diaphragmatic hernia (CDH is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. Methods/design This trial is designed as a multicentre trial in which 400 infants (200 in each arm will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. Discussion To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. Trial registration Netherlands Trial Register (NTR: NTR1310

  16. Reading Aloud: Does Previous Trial History Modulate the Joint Effects of Stimulus Quality and Word Frequency?

    Science.gov (United States)

    O'Malley, Shannon; Besner, Derek

    2013-01-01

    No one would argue with the proposition that how we process events in the world is strongly affected by our experience. Nonetheless, recent experience (e.g., from the previous trial) is typically not considered in the analysis of timed cognitive performance in the laboratory. Masson and Kliegl (2013) reported that, in the context of the lexical…

  17. External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance

    NARCIS (Netherlands)

    Murphy, S.C.; Hermsen, C.C.; Douglas, A.D.; Edwards, N.J.; Petersen, I.; Fahle, G.A.; Adams, M.; Berry, A.A.; Billman, Z.P.; Gilbert, S.C.; Laurens, M.B.; Leroy, O.; Lyke, K.E.; Plowe, C.V.; Seilie, A.M.; Strauss, K.A.; Teelen, K.; Hill, A.V.; Sauerwein, R.W.

    2014-01-01

    Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal

  18. Inactive experiments for advanced separation processes prior to high activity trials in ATALANTE

    International Nuclear Information System (INIS)

    Duhamet, Jean; Lanoe, Jean-Yves; Rivalier, Patrick; Borda, Gilles

    2008-01-01

    Many trials have been performed in ATALANTE's shielded cells to demonstrate the technical feasibility of processes involving minor actinide separation. They required developments of new extractors as well as a step by step procedure have been used to lower the risks of malfunction during high active operation. The design of the extractors developed by Cea has included shielded cells restrictions, miniaturization to lower the quantity of high active material and wastes and the care for being representative of industrial equipment. After individual shake down inactive tests, with actual phases, each process experiment scheduled in ATALANTE has been tested at G1 Facility in Marcoule. The objective was to reproduce as much as possible all the equipment chosen for active tests. This procedure has demonstrated its efficiency to detect many problems that would have heavy impact if they have been discovered during active trials. It was also used for operators'training. (authors)

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

    Science.gov (United States)

    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.

  20. Patient-reported Outcomes in Randomised Controlled Trials of Prostate Cancer: Methodological Quality and Impact on Clinical Decision Making

    Science.gov (United States)

    Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane

    2014-01-01

    Context Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. Objective The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. Evidence acquisition A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Evidence synthesis Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Conclusions Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient

  1. J-pouch versus Roux-en-Y reconstruction after gastrectomy: functional assessment and quality of life (randomized trial

    Directory of Open Access Journals (Sweden)

    Zonca P

    2016-12-01

    Full Text Available Pavel Zonča,1,2 Tomáš Malý,3 Peter Ihnát,1,2 Matus Peteja,1,2 Otakar Kraft,4 Kamil Kuca2,5 1Department of Surgery, University Hospital Ostrava, 2Department of Surgical Studies, Faculty of Medicine, University of Ostrava, Ostrava, 3Department of Surgery, University Hospital Olomouc, Olomouc, 4Department of Nuclear Medicine, University Hospital Ostrava, Ostrava, 5Biomedical Research Center, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic Purpose: The aim of this study was to evaluate the quality of life and functional emptying of J-pouch versus Roux-en-Y reconstruction after total gastrectomy for malignancy. Methods: This study was designed as a prospective, nonblinded, randomized, parallel clinical trial (Trial Number: MN Ostrava, 200604. With informed consent, patients undergoing gastrectomy for malignancy were randomized to J-pouch or Roux-en-Y reconstruction. The time taken for a test semisolid meal labeled with 99mTc-sulfur colloid to exit the reconstructed parts was measured by dynamic scintigraphy 1 year after resection. Quality of life was measured using the Eypasch questionnaire at the same time as functional emptying assessment. This trial was investigator-initiated. Results: In all, 72 patients were included into the study. The time taken for the test meal to exit the postgastrectomy reconstruction was 16.5±10.0 minutes (mean ± standard deviation in the Roux-en-Y group and 89.4±37.8 minutes in the “J-pouch” group; the difference was statistically significant (P<0.001. Emptying of the J-pouch appeared to be a linear decreasing function compared to the exponential pattern seen in the Roux-en-Y group. The quality of life measurement showed scores of 106±18.8 points (mean ± standard deviation in the Roux-en-Y group compared to 122±22.5 points in the J-pouch group; the difference was statistically significant (P=0.0016. There were no important adverse events. Conclusion: After total gastrectomy, a J

  2. Comparing the Effects of Reflexology and Footbath on Sleep Quality in the Elderly: A Controlled Clinical Trial.

    Science.gov (United States)

    Valizadeh, Leila; Seyyedrasooli, Alehe; Zamanazadeh, Vahid; Nasiri, Khadijeh

    2015-11-01

    Sleep disorders are common mental disorders reported among the elderly in all countries, and with nonpharmacological interventions, they could be helped to improve their sleep quality. The aim of this study was to compare the effects of two interventions, foot reflexology and foot bath, on sleep quality in elderly people. This three-group randomized clinical trial (two experimental groups and a control group) was conducted on 69 elderly men. The two experimental groups had reflexology (n = 23) and foot bath (n = 23) interventions for 6 weeks. The reflexology intervention was done in the mornings, once a week for ten minutes on each foot. The participants in the foot bath group were asked to soak their feet in 41°C to 42°C water one hour before sleeping. The pittsburgh sleep quality index (PSQI) was completed before and after the intervention through an interview process. The results showed that the PSQI scores after intervention compared to before it in the reflexology and foot bath groups were statistically significant (P = 0.01 , P = 0.001); however, in the control group did not show a statistically significant difference (P = 0.14). In addition, the total score changes among the three groups were statistically significant (P = 0.01). Comparing the score changes of quality of sleep between the reflexology and foot bath groups showed that there was no significant difference in none of the components and the total score (P = 0.09). The two interventions had the same impact on the quality of sleep. It is suggested that the training of nonpharmacological methods to improve sleep quality such as reflexology and foot bath be included in the elderly health programs. In addition, it is recommended that the impact of these interventions on subjective sleep quality using polysomnographic recordings be explored in future research.

  3. Long-Run Benefits from Universal High-Quality Preschooling

    DEFF Research Database (Denmark)

    Bauchmüller, Robert; Gørtz, Mette; Rasmussen, Astrid Würtz

    2014-01-01

    This paper investigates the role of preschool quality for children's school performance at the end of primary school. We construct five structural quality indicators based on unique Danish administrative register data. 30,444 children finishing primary school's 9th grade in 2008 and who attended ...... in children's test results in Danish. Boys benefit more from preschool quality than girls. Ethnic minority children benefit from higher staff stability....

  4. Low-quality birds do not display high-quality signals: The cysteine-pheomelanin mechanism of honesty

    Science.gov (United States)

    Galván, Ismael; Wakamatsu, Kazumasa; Camarero, Pablo R; Mateo, Rafael; Alonso-Alvarez, Carlos

    2015-01-01

    The mechanisms that make that the costs of producing high-quality signals are unaffordable to low-quality signalers are a current issue in animal communication. The size of the melanin-based bib of male house sparrows Passer domesticus honestly signals quality. We induced the development of new bibs while treating males with buthionine-sulfoximine (BSO), a substance that depletes the levels of the antioxidant glutathione (GSH) and the amino acid cysteine, two elements that switch melanogenesis from eumelanin to pheomelanin. Final bib size is negatively related to pheomelanin levels in the bib feathers. BSO reduced cysteine and GSH levels in all birds, but improved phenotypes (bibs larger than controls) were only expressed by high-quality birds (BSO birds with largest bibs initially). Negative associations between final bib size and cysteine levels in erythrocytes, and between pheomelanin and cysteine levels, were observed in high-quality birds only. These findings suggest that a mechanism uncoupling pheomelanin and cysteine levels may have evolved in low-quality birds to avoid producing bibs of size not corresponding to their quality and greater relative costs. Indeed, greater oxidative stress in cells was not observed in low-quality birds. This may represent the first mechanism maintaining signal honesty without producing greater relative costs on low-quality signalers. PMID:25330349

  5. Systems and processes that ensure high quality care.

    Science.gov (United States)

    Bassett, Sally; Westmore, Kathryn

    2012-10-01

    This is the second in a series of articles examining the components of good corporate governance. It considers how the structures and processes for quality governance can affect an organisation's ability to be assured about the quality of care. Complex information systems and procedures can lead to poor quality care, but sound structures and processes alone are insufficient to ensure good governance, and behavioural factors play a significant part in making sure that staff are enabled to provide good quality care. The next article in this series looks at how the information reporting of an organisation can affect its governance.

  6. Characterization of non equilibrium effects on high quality critical flows

    International Nuclear Information System (INIS)

    Camelo, E.; Lemonnier, H.; Ochterbeck, J.

    1995-01-01

    The appropriate design of various pieces of safety equipment such as relief systems, relies on the accurate description of critical flow phenomena. Most of the systems of industrial interest are willing to be described by one-dimensional area-averaged models and a large fraction of them involves multi-component high gas quality flows. Within these circumstances, the flow is very likely to be of an annular dispersed nature and its description by two-fluid models requires various closure relations. Among the most sensitive closures, there is the interfacial area and the liquid entrained fraction. The critical flowrate depends tremendously on the accurate description of the non equilibrium which results from the correctness of the closure equations. In this study, two-component flows are emphasized and non equilibrium results mainly form the differences in the phase velocities. It is therefore of the utmost importance to have reliable data to characterize non equilibrium phenomena and to assess the validity of the closure models. A comprehensive description of air-water nozzle flows, with emphasis on the effect of the nozzle geometry, has been undertaken and some of the results are presented here which helps understanding the overall flow dynamics. Besides the critical flowrate, the presented material includes pressure profiles, droplet size and velocity, liquid film flowrate and liquid film thickness

  7. Characterization of non equilibrium effects on high quality critical flows

    Energy Technology Data Exchange (ETDEWEB)

    Camelo, E.; Lemonnier, H.; Ochterbeck, J. [Commissariat a l Energie Atomique, Grenoble (France)] [and others

    1995-09-01

    The appropriate design of various pieces of safety equipment such as relief systems, relies on the accurate description of critical flow phenomena. Most of the systems of industrial interest are willing to be described by one-dimensional area-averaged models and a large fraction of them involves multi-component high gas quality flows. Within these circumstances, the flow is very likely to be of an annular dispersed nature and its description by two-fluid models requires various closure relations. Among the most sensitive closures, there is the interfacial area and the liquid entrained fraction. The critical flowrate depends tremendously on the accurate description of the non equilibrium which results from the correctness of the closure equations. In this study, two-component flows are emphasized and non equilibrium results mainly form the differences in the phase velocities. It is therefore of the utmost importance to have reliable data to characterize non equilibrium phenomena and to assess the validity of the closure models. A comprehensive description of air-water nozzle flows, with emphasis on the effect of the nozzle geometry, has been undertaken and some of the results are presented here which helps understanding the overall flow dynamics. Besides the critical flowrate, the presented material includes pressure profiles, droplet size and velocity, liquid film flowrate and liquid film thickness.

  8. A 3-week multimodal intervention involving high-intensity interval training in female cancer survivors: a randomized controlled trial.

    Science.gov (United States)

    Schmitt, Joachim; Lindner, Nathalie; Reuss-Borst, Monika; Holmberg, Hans-Christer; Sperlich, Billy

    2016-02-01

    To compare the effects of a 3-week multimodal rehabilitation involving supervised high-intensity interval training (HIIT) on female breast cancer survivors with respect to key variables of aerobic fitness, body composition, energy expenditure, cancer-related fatigue, and quality of life to those of a standard multimodal rehabilitation program. A randomized controlled trial design was administered. Twenty-eight women, who had been treated for cancer were randomly assigned to either a group performing exercise of low-to-moderate intensity (LMIE; n = 14) or a group performing high-intensity interval training (HIIT; n = 14) as part of a 3-week multimodal rehabilitation program. No adverse events related to the exercise were reported. Work economy improved following both HIIT and LMIE, with improved peak oxygen uptake following LMIE. HIIT reduced mean total body fat mass with no change in body mass, muscle or fat-free mass (best P body mass. Total energy expenditure (P = 0.45) did not change between the groups, whereas both improved quality of life to a similar high extent and lessened cancer-related fatigue. This randomized controlled study demonstrates that HIIT can be performed by female cancer survivors without adverse health effects. Here, HIIT and LMIE both improved work economy, quality of life and cancer-related fatigue, body composition or energy expenditure. Since the outcomes were similar, but HIIT takes less time, this may be a time-efficient strategy for improving certain aspects of the health of female cancer survivors. © 2016 The Authors. Physiological Reports published by Wiley Periodicals, Inc. on behalf of the American Physiological Society and The Physiological Society.

  9. What drives quality improvement in chronic kidney disease (CKD) in primary care: process evaluation of the Quality Improvement in Chronic Kidney Disease (QICKD) trial.

    Science.gov (United States)

    Nihat, Akin; de Lusignan, Simon; Thomas, Nicola; Tahir, Mohammad Aumran; Gallagher, Hugh

    2016-04-06

    This study is a process evaluation of the Quality Improvement in Chronic Kidney Disease (QICKD) study, comparing audit-based education (ABE) and sending clinical guidelines and prompts (G&P) with usual practice, in improving systolic blood pressure control in primary care. This evaluation aimed to explore how far clinical staff in participating practices were aware of the intervention, and why change in practice might have taken place. 4 primary care practices in England: 2 received ABE, and 2 G&P. We purposively selected 1 northern/southern/city and rural practice from each study arm (from a larger pool of 132 practices as part of the QICKD trial). The 4 study practices were purposively sampled, and focus groups conducted with staff from each. All staff members were invited to attend. Focus groups in each of 4 practices, at the mid-study point and at the end. 4 additional trial practices not originally selected for in-depth process evaluation took part in end of trial focus groups, to a total of 12 focus groups. These were recorded, transcribed and analysed using the framework approach. 5 themes emerged: (1) involvement in the study made participants more positive about the CKD register; (2) clinicians did not always explain to patients that they had CKD; (3) while practitioners improved their monitoring of CKD, many were sceptical that it improved care and were more motivated by pay-for-performance measures; (4) the impact of study interventions on practice was generally positive, particularly the interaction with specialists, included in ABE; (5) the study stimulated ideas for future clinical practice. Improving quality in CKD is complex. Lack of awareness of clinical guidelines and scepticism about their validity are barriers to change. While pay-for-performance incentives are the main driver for change, quality improvement interventions can have a complementary influence. Published by the BMJ Publishing Group Limited. For permission to use (where not already

  10. Strengthening exercises improve symptoms and quality of life but do not change autonomic modulation in fibromyalgia: a randomized clinical trial.

    Science.gov (United States)

    Gavi, Maria Bernadete Renoldi Oliveira; Vassalo, Dalton Valentin; Amaral, Fabian Tadeu; Macedo, Danielle Constância Felício; Gava, Pablo Lúcio; Dantas, Eduardo Miranda; Valim, Valéria

    2014-01-01

    Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia (FM). Exercise is an effective treatment, with benefits potentially mediated through changes in autonomic modulation. Strengthening is one of the less studied exercises in FM, and the acute and chronic effects of strengthening on the autonomic system remain unknown. The objective of this study was to assess the chronic effects of strengthening exercises (STRE) on autonomic modulation, pain perception and the quality of life (QOL) of FM patients. Eighty sedentary women with FM (ACR 1990) were randomly selected to participate in STRE or flexibility (FLEX) exercises in a blinded controlled trial. The intensity of STRE was set at 45% of the estimated load of 1 Repetition Maximum (RM) in 12 different exercises. Outcomes were Visual Analog Scale (VAS) for pain, Heart Rate Variability (HRV) analysis, treadmill test, the sit and reach test (Wells and Dillon's Bench), maximal repetitions test and handgrip dynamometry; and quality of life by the Fibromyalgia Impact Questionnaire (FIQ), the Beck and Idate Trait-State Inventory (IDATE), a short-form health survey (SF-36). The STRE group was more effective to strength gain for all muscles and pain control after 4 and 16 weeks (pquality of life, no effect was observed on the autonomic modulation in both groups. This observation suggests that changes in autonomic modulation are not a target tobe clinically achieved in fibromyalgia. ClinicalTrials.gov NCT02004405.

  11. Aura interruption: the Andrews/Reiter behavioral intervention may reduce seizures and improve quality of life - a pilot trial.

    Science.gov (United States)

    Elsas, S M; Gregory, W L; White, G; Navarro, G; Salinsky, M C; Andrews, D J

    2011-12-01

    Patients with epilepsy frequently experience depression and emotional stress and these may function as seizure triggers in epileptogenic frontotemporal cortex, which serves in emotional processing. Eight patients enrolled in a pilot trial of a 6-month epilepsy-specific behavioral approach comprising counseling and relaxation to recognize and eliminate emotional seizure triggers. Potential participants with psychogenic seizures were excluded by long-term EEG and/or the MMPI profile. One participant became seizure free, another had an approximately 90% reduction in seizures, and two additional participants achieved a greater than 50% reduction in seizure frequency (total responder rate=50%), stable during 6 months of observation after the intervention. All completers showed marked and stable improvement of quality of life (Quality of Life in Epilepsy-89 inventory) and temporary improvement in the Profile of Mood States. An adequately powered randomized controlled trial is needed to confirm our findings, which suggest that behavioral approaches may hold promise for motivated patients with epilepsy. Copyright © 2011 Elsevier Inc. All rights reserved.

  12. Radiochemotherapy of locally advanced anal canal carcinoma: Prospective assessment of early impact on the quality of life (randomized trial ACCORD 03)

    International Nuclear Information System (INIS)

    Tournier-Rangeard, Laetitia; Mercier, Mariette; Peiffert, Didier; Gerard, Jean-Pierre; Romestaing, Pascale; Lemanski, Claire; Mirabel, Xavier; Pommier, Pascal; Denis, Bernard

    2008-01-01

    Background and purpose: The aim of this study was to prospectively assess the quality of life (QOL) of patients treated by concomitant chemo radiation for locally advanced anal canal carcinoma. Materials and methods: We report on a subgroup of 119 patients enrolled in a 306-patient therapeutic intensification prospective trial (ACCORD 03). This trial evaluated the impact on colostomy-free survival of induction chemotherapy and/or high dose radiotherapy (factorial design 2 * 2 treatment arms). QOL was assessed both before and 2 months after treatment using the EORTC QLQ-C30 questionnaire as well as a questionnaire relating to anal sphincter conservative treatment (AS-CT). Results: Compared to pre-treatment scores, patients reported significant improvement in their emotional function (+8.4 points p = 0.002), global health status (+5.9 points p = 0.0007), as well as a decrease in insomnia (-13.8 points p < 0.0001), constipation (-12.0 points p < 0.0001), appetite loss (-10.3 points p < 0.0001) and pain (-9.6 points p = 0.0002). The AS-CT degree of satisfaction with intestinal functions score was increased (+11.2 points p < 0.0001). Conclusion: This is the first prospective study comparing QOL of patients with advanced anal canal carcinoma, before and 2 months after conservative treatment. Two months after treatment, QOL was improved. Induction chemotherapy and/or high dose radiotherapy did not provide a negative impact on QOL

  13. Image Quality in High-resolution and High-cadence Solar Imaging

    Science.gov (United States)

    Denker, C.; Dineva, E.; Balthasar, H.; Verma, M.; Kuckein, C.; Diercke, A.; González Manrique, S. J.

    2018-03-01

    Broad-band imaging and even imaging with a moderate bandpass (about 1 nm) provides a photon-rich environment, where frame selection (lucky imaging) becomes a helpful tool in image restoration, allowing us to perform a cost-benefit analysis on how to design observing sequences for imaging with high spatial resolution in combination with real-time correction provided by an adaptive optics (AO) system. This study presents high-cadence (160 Hz) G-band and blue continuum image sequences obtained with the High-resolution Fast Imager (HiFI) at the 1.5-meter GREGOR solar telescope, where the speckle-masking technique is used to restore images with nearly diffraction-limited resolution. The HiFI employs two synchronized large-format and high-cadence sCMOS detectors. The median filter gradient similarity (MFGS) image-quality metric is applied, among others, to AO-corrected image sequences of a pore and a small sunspot observed on 2017 June 4 and 5. A small region of interest, which was selected for fast-imaging performance, covered these contrast-rich features and their neighborhood, which were part of Active Region NOAA 12661. Modifications of the MFGS algorithm uncover the field- and structure-dependency of this image-quality metric. However, MFGS still remains a good choice for determining image quality without a priori knowledge, which is an important characteristic when classifying the huge number of high-resolution images contained in data archives. In addition, this investigation demonstrates that a fast cadence and millisecond exposure times are still insufficient to reach the coherence time of daytime seeing. Nonetheless, the analysis shows that data acquisition rates exceeding 50 Hz are required to capture a substantial fraction of the best seeing moments, significantly boosting the performance of post-facto image restoration.

  14. MEAL-BASED ENHANCEMENT OF PROTEIN QUALITY AND QUANTITY DURING WEIGHT LOSS IN OBESE OLDER ADULTS WITH MOBILITY LIMITATIONS: RATIONALE AND DESIGN FOR THE MEASUR-UP TRIAL

    Science.gov (United States)

    McDonald, Shelley R.; Starr, Kathryn N. Porter; Mauceri, Luisa; Orenduff, Melissa; Granville, Esther; Ocampo, Christine; Payne, Martha E.; Pieper, Carl F.; Bales, Connie W.

    2015-01-01

    Obese older adults with even modest functional limitations are at a disadvantage for maintaining their independence into late life. However, there is no established intervention for obesity in older individuals. The Measuring Eating, Activity and Strength: Understanding the Response --Using Protein (MEASUR-UP) trial is a randomized controlled pilot study of obese women and men aged ≥60 years with mild to moderate functional impairments. Changes in body composition (lean and fat mass) and function (Short Physical Performance Battery) in an enhanced protein weight reduction (Protein) arm will be compared to those in a traditional weight loss (Control) arm. The Protein intervention is based on evidence that older adults achieve optimal rates of muscle protein synthesis when consuming about 25-30 grams of high quality protein per meal; these participants will consume −30 g of animal protein at each meal via a combination of provided protein (beef) servings and diet counseling. This trial will provide information on the feasibility and efficacy of enhancing protein quantity and quality in the context of a weight reduction regimen and determine the impact of this intervention on body weight, functional status, and lean muscle mass. We hypothesize that the enhancement of protein quantity and quality in the Protein arm will result in better outcomes for function and/or lean muscle mass than in the Control arm. Ultimately, we hope our findings will help identify a safe weight loss approach that can delay or prevent late life disability by changing the trajectory of age-associated functional impairment associated with obesity. PMID:25461495

  15. Central pathology review with two-stage quality assurance for pathological response after neoadjuvant chemotherapy in the ARTemis Trial.

    Science.gov (United States)

    Thomas, Jeremy St John; Provenzano, Elena; Hiller, Louise; Dunn, Janet; Blenkinsop, Clare; Grybowicz, Louise; Vallier, Anne-Laure; Gounaris, Ioannis; Abraham, Jean; Hughes-Davies, Luke; McAdam, Karen; Chan, Stephen; Ahmad, Rizvana; Hickish, Tamas; Houston, Stephen; Rea, Daniel; Caldas, Carlos; Bartlett, John Ms; Cameron, David Allan; Hayward, Richard Laurence; Earl, Helena Margaret

    2017-08-01

    The ARTemis Trial tested standard neoadjuvant chemotherapy±bevacizumab in the treatment of HER2-negative early breast cancer. We compare data from central pathology review with report review and also the reporting behavior of the two central pathologists. Eight hundred women with HER2-negative early invasive breast cancer were recruited. Response to chemotherapy was assessed from local pathology reports for pathological complete response in breast and axillary lymph nodes. Sections from the original core biopsy and surgical excision were centrally reviewed by one of two trial pathologists blinded to the local pathology reports. Pathologists recorded response to chemotherapy descriptively and also calculated residual cancer burden. 10% of cases were double-reported to compare the central pathologists' reporting behavior. Full sample retrieval was obtained for 681 of the 781 patients (87%) who underwent surgery within the trial and were evaluable for pathological complete response. Four hundred and eighty-three (71%) were assessed by JSJT, and 198 (29%) were assessed by EP. Residual cancer burden calculations were possible in 587/681 (86%) of the centrally reviewed patients, as 94/681 (14%) had positive sentinel nodes removed before neoadjuvant chemotherapy invalidating residual cancer burden scoring. Good concordance was found between the two pathologists for residual cancer burden classes within the 65-patient quality assurance exercise (kappa 0.63 (95% CI: 0.57-0.69)). Similar results were obtained for the between-treatment arm comparison both from the report review and the central pathology review. For pathological complete response, report review was as good as central pathology review but for minimal residual disease, report review overestimated the extent of residual disease. In the ARTemis Trial central pathology review added little in the determination of pathological complete response but had a role in evaluating low levels of residual disease. Calculation

  16. Quality Assurance Roadmap for High Performance Residential Buildings

    Energy Technology Data Exchange (ETDEWEB)

    None

    2008-10-05

    This report outlines the approach to quality assurance in the construction process for new residential construction, including seven process steps from the assessment of current construction practice, through design and documentation changes, to training and quality control for on-site personnel.

  17. Paying for High- and Low-Quality Teaching

    Science.gov (United States)

    Schacter, John; Thum, Yeow Meng

    2004-01-01

    The extensive research on teacher quality has led to two conclusions. First, there are large and significant differences among teachers in terms of their capacity to improve student achievement. Second, these differences are not captured by common measures of teacher qualifications (E.A. Hanushek, Teacher quality, in: L.T. Izumi, W.M. Evers…

  18. Effect of weight reduction on the quality of life in obese patients with fibromyalgia syndrome: a randomized controlled trial.

    Science.gov (United States)

    Senna, Mohammed Kamal; Sallam, Rehab Abd-El Raouf; Ashour, Hala Salah; Elarman, Mohammed

    2012-11-01

    The aim of the study was to examine whether weight reduction can result in improvement of fibromyalgia impact questionnaire (FIQ) in the patients with fibromyalgia syndrome (FMS). This study was a randomized controlled trial. Obese patients with fibromyalgia were randomly assigned to 6-month dietary weight loss (n = 41) and no weight loss (n = 42) groups. Patients were assessed at baseline and at 6 months. The primary outcome measure was FIQ. Secondary measures included the tender point (TP) examination, Beck Depression Inventory-II, and Pittsburg Sleep Quality Index. Compared to the control group, patients who underwent weight reduction obtained significantly better FIQ (p = 0.007), lower mean TP count (p = 0.015), and lower mean TP pain rating in the lower body (p quality than the controls. Patients who lost weight had significantly lower interleukin 6 and C-reactive protein levels than those in the control group (p = 0.034 and p = 0.007, respectively). Weight loss in obese patients with FMS leads to significant improvement in the quality of life as shown by the decrease in the FIQ score. Depression, sleep quality, and tender point count are also significantly improved by weight loss in obese patients with fibromyalgia. Our results suggest that weight reduction should be a part of fibromyalgia treatment.

  19. Quality of reporting of randomised controlled trials of herbal interventions in ASEAN Plus Six Countries: a systematic review.

    Science.gov (United States)

    Pratoomsoot, Chayanin; Sruamsiri, Rosarin; Dilokthornsakul, Piyameth; Chaiyakunapruk, Nathorn

    2015-01-01

    Many randomised controlled trials (RCTs) of herbal interventions have been conducted in the ASEAN Communities. Good quality reporting of RCTs is essential for assessing clinical significance. Given the importance ASEAN placed on herbal medicines, the reporting quality of RCTs of herbal interventions among the ASEAN Communities deserved a special attention. To systematically review the quality of reporting of RCTs of herbal interventions conducted in the ASEAN Plus Six Countries. Searches were performed using PubMed, EMBASE, The Cochrane Library, and Allied and Complementary Medicine (AMED), from inception through October 2013. These were limited to studies specific to humans and RCTs. Herbal species search terms were based on those listed in the National List of Essential Medicines [NLEM (Thailand, 2011)]. Studies conducted in the ASEAN Plus Six Countries, published in English were included. Seventy-one articles were identified. Thirty (42.25%) RCTs were from ASEAN Countries, whereas 41 RCTs (57.75%) were from Plus Six Group. Adherence to the recommended CONSORT checklist items for reporting of RCTs of herbal interventions among ASEAN Plus Six Countries ranged from 0% to 97.18%. Less than a quarter of the RCTs (18.31%) reported information on standardisation of the herbal products. However, the scope of our interventions of interest was limited to those developed from 20 herbal species listed in the NLEM of Thailand. The present study highlights the need to improve reporting quality of RCTs of herbal interventions across ASEAN Plus Six Communities.

  20. Comparisons for Effectiveness of Aromatherapy and Acupressure Massage on Quality of Life in Career Women: A Randomized Controlled Trial.

    Science.gov (United States)

    Kao, Yu-Hsiu; Huang, Yi-Ching; Chung, Ue-Lin; Hsu, Wen-Ni; Tang, Yi-Ting; Liao, Yi-Hung

    2017-06-01

    This study was aimed to compare the effectiveness of aromatherapy and acupressure massage intervention strategies on the sleep quality and quality of life (QOL) in career women. The randomized controlled trial experimental design was used in the present study. One hundred and thirty-two career women (24-55 years) voluntarily participated in this study and they were randomly assigned to (1) placebo (distilled water), (2) lavender essential oil (Lavandula angustifolia), (3) blended essential oil (1:1:1 ratio of L. angustifolia, Salvia sclarea, and Origanum majorana), and (4) acupressure massage groups for a 4-week treatment. The Pittsburgh Sleep Quality Index and Short Form 36 Health Survey were used to evaluate the intervention effects at pre- and postintervention. After a 4-week treatment, all experimental groups (blended essential oil, lavender essential oil, and acupressure massage) showed significant improvements in sleep quality and QOL (p aromatherapy and acupressure massage improve the sleep and QOL and may serve as the optimal means for career women to improve their sleep and QOL.

  1. Evaluation of Valerians’ effect on sleep quantity and quality of menopausal women: cross-over clinical trial

    Directory of Open Access Journals (Sweden)

    Mandana Mirmohammadali

    2014-02-01

    Full Text Available Background: Menopause causes poor sleep quality in women, so that great throngs of menopausal women experience menopause-induced sleep disorders. This study was conducted to determine the effects of valerian extract on sleep quantity and quality of postmenopausal women. Methods: This triple-blind, randomized, cross-over clinical trial was performed on 144 eligible postmenopausal women. Participants were randomly classified into two groups to use either 700 mg valerian extract (group A or a placebo (group B for one month. After a 2-week washout period, the treatment regimens were reversed. Sleep quantity and quality were evaluated using Pittsburgh and Insomnia Severity Index (ISI questionnaires at baseline and after both phases of intervention. Results: Mean score of Pittsburgh scale was 10.93.6 at baseline. Valerian reduced this score to 7.83.4 and 7.43 at the first and the second phase of intervention, respectively (P<0.001. After the first phase of intervention, ISI score was reduced to 2.870.62 in group A (P<0.001. It was reduced to 4.020.5 in group B after the second phase of intervention (P<0.001. Conclusion: Daily consumption of 700 mg valerian improved sleep quantity and quality in postmenopausal women

  2. The Effects of Aromatherapy on Intensive Care Unit Patients’ Stress and Sleep Quality: A Nonrandomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Eun Hee Cho

    2017-01-01

    Full Text Available Background. Stress has both physiological and psychological effects and can negatively impact patients’ treatment and recovery. We examined whether the aromatherapy alleviated patients’ stress and improved their sleep quality and provided data that can be utilized in clinical settings. Methods. This was a nonrandomised controlled experimental study. Participants included lucid adult patients who were admitted to the intensive care unit and had spent more than two nights there. The experimental treatment required participants to engage in deep breathing with essential oils as part of the aromatherapy. The control group was instructed to go to sleep without receiving the lavender aroma oil. Results. The experimental group and control group showed a significant difference in perceived stress (F=60.11, p<.001, objective stress index (F=25.65, p<.001, systolic blood pressure (F=9.09, p<.001, diastolic blood pressure (F=2.47, p=.046, heart rate (F=5.71, p<.001, and sleep quality (F=109.46, p<.001. Conclusions. The results revealed that aromatherapy alleviated stress and improved sleep quality in intensive care unit patients after 2 days of the experimental treatment. These results demonstrate that aromatherapy affects stress and sleep quality, thus indicating its value in nursing interventions. This trial is registered with KCT0002344.

  3. EORTC 22972-26991/MRC BR10 trial: Fractionated stereotactic boost following conventional radiotherapy of high grade gliomas

    International Nuclear Information System (INIS)

    Baumert, Brigitta G.; Brada, Michael; Bernier, Jacques; Kortmann, Rolf D.; Dehing-Oberije, Cary; Collette, Laurence; Davis, J. Bernard

    2008-01-01

    Background and purpose: The EORTC trial No. 22972 investigated the role of an additional fractionated stereotactic boost (fSRT) to conventional radiotherapy for patients with high grade gliomas. A quality-assurance (QA) programme was run in conjunction with the study and was the first within the EORTC addressing the quality of a supposedly highly accurate treatment technique such as stereotactic radiotherapy. A second aim was to investigate a possible relation between the clinical results of the stereotactic boost arm and the results of the QA. Materials and methods: The trial was closed in 2001 due to low accrual. In total, 25 patients were randomized: 14 into the experimental arm and 11 into the control arm. Six centres randomized patients, 8 centres had completed the dummy run (DR) for the stereotactic boost part. All participating centres (9) were asked to complete a quality-assurance questionnaire. The DR consisted of treatment planning according to the guidelines of the protocol on 3 different tumour volumes drawn on CT images of a humanized phantom. The SRT technique to be used was evaluated by the questionnaire. Clinical data from patients recruited to the boost arm from 6 participating centres were analysed. Results: There was a full compliance to the protocol requirements for 5 centres. Major and minor deviations in conformality were observed for 2 and 3 centres, respectively. Of the 8 centres which completed the DR, one centre did not comply with the requirements of stereotactic radiotherapy concerning accuracy, dosimetry and planning. Median follow-up and median overall survival were 39.2 and 21.4 months, respectively. Acute and late toxicities of the stereotactic boost were low. One radiation necrosis was seen for a patient who has not received the SRT boost. Three reported serious adverse events were all seizures and probably therapy-related. Conclusions: Overall compliance was good but not ideal from the point of view of this highly precise radiation

  4. A review of randomized controlled trials of medical record powered clinical decision support system to improve quality of diabetes care.

    Science.gov (United States)

    Ali, Syed Mustafa; Giordano, Richard; Lakhani, Saima; Walker, Dawn Marie

    2016-03-01

    A gap between current diabetes care practice and recommended diabetes care standards has consistently been reported in the literature. Many IT-based interventions have been developed to improve adherence to the quality of care standards for chronic illness like diabetes. The widespread implementation of electronic medical/health records has catalyzed clinical decision support systems (CDSS) which may improve the quality of diabetes care. Therefore, the objective of the review is to evaluate the effectiveness of CDSS in improving quality of type II diabetes care. Moreover, the review aims to highlight the key indicators of quality improvement to assist policy makers in development of future diabetes care policies through the integration of information technology and system. Setting inclusion criteria, a systematic literature search was conducted using Medline, Web of Science and Science Direct. Critical Appraisal Skills Programme (CASP) tools were used to evaluate the quality of studies. Eight randomized controlled trials (RCTs) were selected for the review. In the selected studies, seventeen clinical markers of diabetes care were discussed. Three quality of care indicators were given more importance in monitoring the progress of diabetes care, which is consistent with National Institute for Health and Care Excellence (NICE) guidelines. The presence of these indicators in the studies helped to determine which studies were selected for review. Clinical- and process-related improvements are compared between intervention group using CDSS and control group with usual care. Glycated hemoglobin (HbA1c), low density lipid cholesterol (LDL-C) and blood pressure (BP) were the quality of care indicators studied at the levels of process of care and clinical outcome. The review has found both inconsistent and variable results for quality of diabetes care measures. A significant improvement has been found in the process of care for all three measures of quality of diabetes care

  5. Teaching quality: High school students' autonomy and competence.

    Science.gov (United States)

    León, Jaime; Medina-Garrido, Elena; Ortega, Miriam

    2018-05-01

    How teachers manage class learning and interact with students affects students’ motivation and engagement. However, it could be that the effect of students’ representation of teaching quality on the students’ motivation varies between classes. Students from 90 classes participated in the study. We used multilevel random structural equation modeling to analyze whether the relationship of the students’ perception of teaching quality (as an indicator of the students’ mental representation) and students’ motivation varies between classes, and if this variability depends on the class assessment of teaching quality (as an indicator of teaching quality). The effect of teachers’ structure on the regression slope of student perception of student competence was .127. The effect of teachers’ autonomy support on the regression slope of student perception of student autonomy was .066. With this study we contribute a more detailed description of the relationship between teaching quality, competence and autonomy.

  6. Implications of medical devices quality assurance for implementation of experimental clinical trials

    International Nuclear Information System (INIS)

    Tirindelli Danesi, D.; Altavista, P.; Marino, C.; Benassi, M.

    1992-01-01

    The basis for all controlled clinical trials is the comparison of a new treatment with the standard treatment. The effect of the experimental procedure on the natural history of the disease is the result observed; but the interpretation of the results in cancer clinical experimentation is often difficult due to the variability of the clinical course of individual cancers in a given category. It has been possible to categorize cancers by means of prognostic factors and evaluate the results of therapy within each prognostic category, but there is still much variability within each category. The only way to determine whether or not a new treatment can be used for a particular form of cancer is to try it out on patients in clinical trials. The cooperative practice was originally induced by the realistic need for large sample sizes, but the variability in the interpretation of the results increased due to difficulties in comparing data. This is one of the main problems in cancer literature. These problems originate from inconsistent or incomplete reporting of the patient population under study, the treatment administered, the statistical methods employed to assess treatment efficacy and from differences in the definition of response criteria. This paper tries to outline the impact on the results evaluation of the lack of standardized prognostic factors and standardized therapeutic modalities in the selection and treatment of patients included in clinical trials

  7. A regular yoga intervention for staff nurse sleep quality and work stress: a randomised controlled trial.

    Science.gov (United States)

    Fang, Ronghua; Li, Xia

    2015-12-01

    Although many studies have assessed the efficacy of yoga in older individuals, minimal research has focused on how nurses use yoga to improve sleep quality and to reduce work stress after work hours. We used the Pittsburgh Sleep Quality Index in Chinese and the Questionnaire on Medical Worker's Stress in Chinese to determine the impact of yoga on the quality of sleep and work stress of staff nurses employed by a general hospital in China. Disturbances in the circadian rhythm interrupt an individual's pattern of sleep. Convenient sampling method. One hundred and twenty nurses were randomised into two groups: a yoga group and a non-yoga group. The yoga group performed yoga more than two times every week for 50-60 minutes each time after work hours. The NG group did not participate in yoga. After six months, self-reported sleep quality and work stress were compared between the two groups, and then we used linear regression to confirm the independent factors related to sleep quality. Nurses in the yoga group had better sleep quality and lower work stress compared with nurses in the non-yoga group. The linear regression model indicated that nursing experience, age and yoga intervention were significantly related to sleep quality. Regular yoga can improve sleep quality and reduce work stress in staff nurses. This study provides evidence that hospital management should pay attention to nurse sleep quality and work stress, thereby taking corresponding measures to reduce work pressure and improve health outcomes. © 2015 John Wiley & Sons Ltd.

  8. New developments in high quality grey cast irons

    Directory of Open Access Journals (Sweden)

    Iulian Riposan

    2014-07-01

    Full Text Available The paper reviews original data obtained by the present authors, revealed in recent separate publications, describing specific procedures for high quality grey irons, and reflecting the forecast needs of the worldwide iron foundry industry. High power, medium frequency coreless induction furnaces are commonly used in electric melting grey iron foundries. This has resulted in low sulphur (1,500 °C, contributing to unfavourable conditions for graphite nucleation. Thin wall castings are increasingly produced by these electric melt shops with a risk of greater eutectic undercooling during solidification. The paper focused on two groups of grey cast irons and their specific problems: carbides and graphite morphology control in lower carbon equivalent high strength irons (CE=3.4%-3.8%, and austenite dendrite promotion in eutectic and slightly hypereutectic irons (CE=4.1%-4.5%, in order to increase their strength characteristics. There are 3 stages and 3 steps involving graphite formation, iron chemistry and iron processing that appear to be important. The concept in the present paper sustains a threestage model for nucleating flake graphite [(Mn,XS type nuclei]. There are three important groups of elements (deoxidizer, Mn/S, and inoculant and three technological stages in electric melting of iron (superheat, pre-conditioning of base iron, final inoculation. Attention is drawn to a control factor (%Mn x (%S ensuring it equals to 0.03 – 0.06, accompanied by 0.005wt.%–0.010wt.% Al and/or Zr content in inoculated irons. It was found that iron powder addition promotes austenite dendrite formation in eutectic and slightly eutectic, acting as reinforcement for the eutectic cells. But, there is an accompanying possible negative influence on the characteristics of the (Mn,XS type graphite nuclei (change the morphology of nuclei from polygonal compact to irregular polygonal, and therefore promote chill tendency in treated irons. A double addition (iron

  9. The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial.

    Science.gov (United States)

    van den Hout, Lieke; Tibboel, Dick; Vijfhuize, Sanne; te Beest, Harma; Hop, Wim; Reiss, Irwin

    2011-11-02

    Congenital diaphragmatic hernia (CDH) is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO) to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. This trial is designed as a multicentre trial in which 400 infants (200 in each arm) will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. Netherlands Trial Register (NTR): NTR1310.

  10. The effect of nutritional supplementation on quality of life in people living with HIV: a randomised controlled trial.

    Science.gov (United States)

    Tesfaye, Markos; Kaestel, Pernille; Olsen, Mette Frahm; Girma, Tsinuel; Yilma, Daniel; Abdissa, Alemseged; Ritz, Christian; Michaelsen, Kim F; Hanlon, Charlotte; Friis, Henrik

    2016-06-01

    To determine the effects of lipid-based nutrient supplements (LNS) on the quality of life of people living with HIV (PLHIV) during the first 3 months of antiretroviral treatment (ART) and to investigate the effects of timing of supplementation by comparing with supplementation during the subsequent 3 months. A randomised controlled trial was conducted in three ART clinics within public health facilities in Jimma, Ethiopia. Participants were PLHIV eligible to start ART with body mass index >17 kg/m(2) and given daily supplements of 200 g of LNS containing whey or soya either during the first 3 months or the subsequent months of ART. The outcome was measured in terms of total quality-of-life scores on the adapted version of the WHOQOL-HIV-BREF assessed at baseline, three and six months. Of the 282 participants, 186 (66.0%) were women. The mean age (SD) was 32.8 (±9.0) years, and the mean (SD) total quality-of-life score was 82.0 (±14.8) at baseline assessment. At 3 months, participants who received LNS showed better quality of life than those who only received ART without LNS (β = 6.2, 95% CI: 2.9: 9.6). At 6 months, there was no difference in total quality-of-life score between the early and delayed supplementation groups (β = 3.0, 95% CI: -0.4: 6.4). However, the early supplementation group showed higher scores on the social and spirituality domains than the delayed group. LNS given during the first three months of ART improves the quality of life of PLHIV. © 2016 John Wiley & Sons Ltd.

  11. Effects of ethnic attributes on the quality of family planning services in Lima, Peru: a randomized crossover trial.

    Directory of Open Access Journals (Sweden)

    Maria-Elena Planas

    Full Text Available Most studies reporting ethnic disparities in the quality of healthcare come from developed countries and rely on observational methods. We conducted the first experimental study to evaluate whether health providers in Peru provide differential quality of care for family planning services, based on the indigenous or mestizo (mixed ethnoracial ancestry profile of the patient. In a crossover randomized controlled trial conducted in 2012, a sample of 351 out of the 408 public health establishments in Metropolitan Lima, Peru were randomly assigned to receive unannounced simulated patients enacting indigenous and mestizo profiles (sequence-1 or mestizo and then indigenous profiles (sequence-2, with a five week wash-out period. Both ethnic profiles used the same scripted scenario for seeking contraceptive advice but had distinctive cultural attributes such as clothing, styling of hair, make-up, accessories, posture and patterns of movement and speech. Our primary outcome measure of quality of care is the proportion of technical tasks performed by providers, as established by Peruvian family planning clinical guidelines. Providers and data analysts were kept blinded to the allocation. We found a non-significant mean difference of -0.7% (p = 0.23 between ethnic profiles in the percentage of technical tasks performed by providers. However we report large deficiencies in the compliance with quality standards of care for both profiles. Differential provider behaviour based on the patient's ethnic profiles compared in the study did not contribute to deficiencies in family planning outcomes observed. The study highlights the need to explore other determinants for poor compliance with quality standards, including demand and supply side factors, and calls for interventions to improve the quality of care for family planning services in Metropolitan Lima.

  12. Severe Health-Related Quality of Life Impairment in Active Primary Sjögren's Syndrome and Patient-Reported Outcomes: Data From a Large Therapeutic Trial.

    Science.gov (United States)

    Cornec, Divi; Devauchelle-Pensec, Valérie; Mariette, Xavier; Jousse-Joulin, Sandrine; Berthelot, Jean-Marie; Perdriger, Aleth; Puéchal, Xavier; Le Guern, Véronique; Sibilia, Jean; Gottenberg, Jacques-Eric; Chiche, Laurent; Hachulla, Eric; Yves Hatron, Pierre; Goeb, Vincent; Hayem, Gilles; Morel, Jacques; Zarnitsky, Charles; Dubost, Jean Jacques; Saliou, Philippe; Pers, Jacques Olivier; Seror, Raphaèle; Saraux, Alain

    2017-04-01

    To identify the principal determinants of health-related quality of life (HRQOL) impairment in patients with active primary Sjögren's syndrome (SS) participating in a large therapeutic trial, Tolerance and Efficacy of Rituximab in Primary Sjögren's Syndrome (TEARS). At the inclusion visit for the TEARS trial, 120 patients with active primary SS completed the Short Form 36 health survey (SF-36), a validated HRQOL assessment tool. Univariate then multivariate linear regression analyses were used to assess associations linking SF-36 physical and mental components to demographic data, patient-reported outcomes (symptom intensity assessments for dryness, pain, and fatigue, including the European League Against Rheumatism [EULAR] Sjögren's Syndrome Patient Reported Index [ESSPRI]), objective measures of dryness and autoimmunity, and physician evaluation of systemic activity (using the EULAR Sjögren's Syndrome Disease Activity Index [ESSDAI]). SF-36 scores indicated marked HRQOL impairments in our population with active primary SS. Approximately one-third of the patients had low, moderate, and high systemic activity according to the ESSDAI. ESSPRI and ESSDAI scores were moderately but significantly correlated. The factors most strongly associated with HRQOL impairment were patient-reported symptoms, best assessed using the ESSPRI, with pain and ocular dryness intensity showing independent associations with HRQOL. Conversely, systemic activity level was not associated with HRQOL impairment in multivariate analyses, even in the patient subset with ESSDAI values indicating moderate-to-high systemic activity. The cardinal symptoms of primary SS (dryness, pain, and fatigue, best assessed using the ESSPRI) are stronger predictors of HRQOL impairment than systemic involvement (assessed by the ESSDAI) and should be used as end points in future therapeutic trials focusing on patients' well-being. New consensual and data-driven response criteria are needed for primary SS

  13. Physics and quality assurance for high dose rate brachytherapy

    International Nuclear Information System (INIS)

    Anderson, Lowell L.

    1995-01-01

    Purpose: To review the physical aspects of high dose rate (HDR) brachytherapy, including commissioning and quality assurance, source calibration and dose distribution measurements, and treatment planning methods. Following the introduction of afterloading in brachytherapy, development efforts to make it 'remote' culminated in 1964 with the near-simultaneous appearance of remote afterloaders in five major medical centers. Four of these machines were 'high dose rate', three employing 60Co and one (the GammaMed) using a single, cable-mounted 192Ir source. Stepping-motor source control was added to the GammaMed in 1974, making it the precursor of modern remote afterloaders, which are now suitable for interstitial as well as intracavitary brachytherapy by virtue of small source-diameter and indexer-accessed multiple channels. Because the 192Ir sources currently used in HDR remote afterloaders are supplied at a nominal air-kerma strength of 11.4 cGy cm2 s-1 (10 Ci), are not collimated in clinical use, and emit a significant fraction (15%) of photons at energies greater than 600 keV, shielding and facility design must be undertaken as carefully and thoroughly as for external beam installations. Licensing requirements of regulatory agencies must be met with respect both to maximum permissible dose limits and to the existence and functionality of safety devices (door interlocks, radiation monitors, etc.). Commissioning and quality assurance procedures that must be documented for HDR remote afterloading relate to (1) machine, applicator, guide-tube, and facility functionality checks, (2) source calibration, (3) emergency response readiness, (4) planning software evaluation, and (5) independent checks of clinical dose calculations. Source calibration checks must be performed locally, either by in-air measurement of air kerma strength or with a well ionization chamber calibrated (by an accredited standards laboratory) against an in-air measurement of air kerma strength for the

  14. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

    Science.gov (United States)

    2011-01-01

    Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

  15. Twin pregnancy possibly associated with high semen quality

    DEFF Research Database (Denmark)

    Asklund, Camilla; Jensen, Tina Kold; Jørgensen, Niels

    2007-01-01

    BACKGROUND: Recent studies found an association between a long waiting time to pregnancy (TTP) and reduced probability of twinning and a reduced dizygotic (DZ) twinning rate in subfertile men. However, it remains unsolved whether semen quality is associated with twin offspring. We therefore studied...... the semen quality in a group of fathers of naturally conceived twins. METHODS: In this study, 37 fathers of DZ twins and 15 fathers of monozygotic (MZ) twins participated, and 349 normal fertile men served as a reference group. All men delivered a semen sample, underwent a physical examination and completed...... points higher than the reference group (P semen quality than the reference group, which supports...

  16. Evolution of Randomized Trials in Advanced/Metastatic Soft Tissue Sarcoma: End Point Selection, Surrogacy, and Quality of Reporting.

    Science.gov (United States)

    Zer, Alona; Prince, Rebecca M; Amir, Eitan; Abdul Razak, Albiruni

    2016-05-01

    Randomized controlled trials (RCTs) in soft tissue sarcoma (STS) have used varying end points. The surrogacy of intermediate end points, such as progression-free survival (PFS), response rate (RR), and 3-month and 6-month PFS (3moPFS and 6moPFS) with overall survival (OS), remains unknown. The quality of efficacy and toxicity reporting in these studies is also uncertain. A systematic review of systemic therapy RCTs in STS was performed. Surrogacy between intermediate end points and OS was explored using weighted linear regression for the hazard ratio for OS with the hazard ratio for PFS or the odds ratio for RR, 3moPFS, and 6moPFS. The quality of reporting for efficacy and toxicity was also evaluated. Fifty-two RCTs published between 1974 and 2014, comprising 9,762 patients, met the inclusion criteria. There were significant correlations between PFS and OS (R = 0.61) and between RR and OS (R = 0.51). Conversely, there were nonsignificant correlations between 3moPFS and 6moPFS with OS. A reduction in the use of RR as the primary end point was observed over time, favoring time-based events (P for trend = .02). In 14% of RCTs, the primary end point was not met, but the study was reported as being positive. Toxicity was comprehensively reported in 47% of RCTs, whereas 14% inadequately reported toxicity. In advanced STS, PFS and RR seem to be appropriate surrogates for OS. There is poor correlation between OS and both 3moPFS and 6moPFS. As such, caution is urged with the use of these as primary end points in randomized STS trials. The quality of toxicity reporting and interpretation of results is suboptimal. © 2016 by American Society of Clinical Oncology.

  17. Quality assurance in the 22991 EORTC ROG trial in localized prostate cancer: Dummy run and individual case review

    International Nuclear Information System (INIS)

    Matzinger, Oscar; Poortmans, Philip; Giraud, Jean-Yves; Maingon, Philippe; Budiharto, Tom; Bergh, Alfons C.M. van den; Davis, J. Bernard; Musat, Elena; Ataman, Fatma; Huyskens, Dominique P.; Gulyban, Akos; Bolla, Michel

    2009-01-01

    Introduction: EORTC trial 22991 was designed to evaluate the addition of concomitant and adjuvant short-term hormonal treatments to curative radiotherapy in terms of disease-free survival for patients with intermediate risk localized prostate cancer. In order to assess the compliance to the 3D conformal radiotherapy protocol guidelines, all participating centres were requested to participate in a dummy run procedure. An individual case review was performed for the largest recruiting centres as well. Materials and methods: CT-data of an eligible prostate cancer patient were sent to 30 centres including a description of the clinical case. The investigator was requested to delineate the volumes of interest and to perform treatment planning according to the protocol. Thereafter, the investigators of the 12 most actively recruiting centres were requested to provide data on five randomly selected patients for an individual case review. Results: Volume delineation varied significantly between investigators. Dose constraints for organs at risk (rectum, bladder, hips) were difficult to meet. In the individual case review, no major protocol deviations were observed, but a number of dose reporting problems were documented for centres using IMRT. Conclusions: Overall, results of this quality assurance program were satisfactory. The efficacy of the combination of a dummy run procedure with an individual case review is confirmed in this study, as none of the evaluated patient files harboured a major protocol deviation. Quality assurance remains a very important tool in radiotherapy to increase the reliability of the trial results. Special attention should be given when designing quality assurance programs for more complex irradiation techniques

  18. Pretreatment data is highly predictive of liver chemistry signals in clinical trials

    Directory of Open Access Journals (Sweden)

    Cai Z

    2012-11-01

    Full Text Available Zhaohui Cai,1,* Anders Bresell,2,* Mark H Steinberg,1 Debra G Silberg,1 Stephen T Furlong11AstraZeneca Pharmaceuticals, Wilmington, DE, USA; 2AstraZeneca Pharmaceuticals, Södertälje, Sweden*These authors contributed equally to this workPurpose: The goal of this retrospective analysis was to assess how well predictive models could determine which patients would develop liver chemistry signals during clinical trials based on their pretreatment (baseline information.Patients and methods: Based on data from 24 late-stage clinical trials, classification models were developed to predict liver chemistry outcomes using baseline information, which included demographics, medical history, concomitant medications, and baseline laboratory results.Results: Predictive models using baseline data predicted which patients would develop liver signals during the trials with average validation accuracy around 80%. Baseline levels of individual liver chemistry tests were most important for predicting their own elevations during the trials. High bilirubin levels at baseline were not uncommon and were associated with a high risk of developing biochemical Hy’s law cases. Baseline γ-glutamyltransferase (GGT level appeared to have some predictive value, but did not increase predictability beyond using established liver chemistry tests.Conclusion: It is possible to predict which patients are at a higher risk of developing liver chemistry signals using pretreatment (baseline data. Derived knowledge from such predictions may allow proactive and targeted risk management, and the type of analysis described here could help determine whether new biomarkers offer improved performance over established ones.Keywords: bilirubin, Hy’s Law, ALT, GGT, baseline, prediction

  19. High quality ceramic coatings sprayed by high efficiency hypersonic plasma spraying gun

    International Nuclear Information System (INIS)

    Zhu Sheng; Xu Binshi; Yao JiuKun

    2005-01-01

    This paper introduced the structure of the high efficiency hypersonic plasma spraying gun and the effects of hypersonic plasma jet on the sprayed particles. The optimised spraying process parameters for several ceramic powders such as Al 2 O 3 , Cr 2 O 3 , ZrO 2 , Cr 3 C 2 and Co-WC were listed. The properties and microstructure of the sprayed ceramic coatings were investigated. Nano Al 2 O 3 -TiO 2 ceramic coating sprayed by using the high efficiency hypersonic plasma spraying was also studied. Compared with the conventional air plasma spraying, high efficiency hypersonic plasma spraying improves greatly the ceramic coatings quality but at low cost. (orig.)

  20. A novel high resolution and high efficiency dual head detector for molecular breast imaging: New results from clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Garibaldi, F., E-mail: franco.garibaldi@iss.infn.i [ISS and INFN Roma, gr. Sanita, Rome (Italy); Cisbani, E.; Colilli, S.; Cusanno, F.; Fratoni, R.; Giuliani, F.; Gricia, M.; Lucentini, M.; Magliozzi, M.L.; Santavenere, F.; Torrioli, S. [ISS and INFN Roma, gr. Sanita, Rome (Italy); Musico, P. [INFN Genova, Genova (Italy); Argentieri, A. [INFN Bari, Bari (Italy); Cossu, E.; Padovano, F.; Simonetti, G. [ISS and INFN Roma, gr. Sanita, Rome (Italy); Schillaci, O. [University of Tor Vergata, Rome (Italy); Majewski, S. [West Virginia University, Morgantown, West Virginia (United States)

    2010-05-21

    Detecting small breast tumors is a challenging task. Molecular Breast Imaging with radionuclides has a central role to play in this respect. Our group has recently designed and implemented a dual detector setup that allows spot compression and improves significantly the performance of the system. The single head detector has been successfully used for clinical trials with 10 patients in comparison with a commercial high resolution detector. Then the dual head system has been showed to have significant advantages for the detection of small tumors.

  1. Safe and high quality food production using low quality waters and improved irrigation systems and management

    DEFF Research Database (Denmark)

    Plauborg, Finn; Andersen, Mathias Neumann; Liu, Fulai

    2010-01-01

    uneven irrigation patterns can increase the water use efficiency as well as the quality of vegetable crops. Furthermore, recent innovations in the water treatment and irrigation industry have shown potential for the use of low quality water resources, such as reclaimed water or surface water in peri...

  2. High throughput electrospinning of high-quality nanofibers via an aluminum disk spinneret

    Science.gov (United States)

    Zheng, Guokuo

    In this work, a simple and efficient needleless high throughput electrospinning process using an aluminum disk spinneret with 24 holes is described. Electrospun mats produced by this setup consisted of fine fibers (nano-sized) of the highest quality while the productivity (yield) was many times that obtained from conventional single-needle electrospinning. The goal was to produce scaled-up amounts of the same or better quality nanofibers under variable concentration, voltage, and the working distance than those produced with the single needle lab setting. The fiber mats produced were either polymer or ceramic (such as molybdenum trioxide nanofibers). Through experimentation the optimum process conditions were defined to be: 24 kilovolt, a distance to collector of 15cm. More diluted solutions resulted in smaller diameter fibers. Comparing the morphologies of the nanofibers of MoO3 produced by both the traditional and the high throughput set up it was found that they were very similar. Moreover, the nanofibers production rate is nearly 10 times than that of traditional needle electrospinning. Thus, the high throughput process has the potential to become an industrial nanomanufacturing process and the materials processed by it may be used as filtration devices, in tissue engineering, and as sensors.

  3. A Cluster-Randomised Trial of Staff Education to Improve the Quality of Life of People with Dementia Living in Residential Care: The DIRECT Study

    OpenAIRE

    Beer, Christopher; Horner, Barbara; Flicker, Leon; Scherer, Samuel; Lautenschlager, Nicola T.; Bretland, Nick; Flett, Penelope; Schaper, Frank; Almeida, Osvaldo P.

    2011-01-01

    BACKGROUND: The Dementia In Residential care: EduCation intervention Trial (DIRECT) was conducted to determine if delivery of education designed to meet the perceived need of GPs and care staff improves the quality of life of participants with dementia living in residential care. METHODOLOGY/PRINCIPAL FINDINGS: This cluster-randomised controlled trial was conducted in 39 residential aged care facilities in the metropolitan area of Perth, Western Australia. 351 care facility residents aged 65 ...

  4. Improving the quality of pork and pork products for the consumer : development of innovative, integrated, and sustainable food production chains of high quality pork products matching consumer demands

    NARCIS (Netherlands)

    Heimann, B.; Christensen, M.; Rosendal Rasmussen, S.; Bonneau, M.; Grunert, K.G.; Arnau, J.; Trienekens, J.H.; Oksbjerg, N.; Greef, de K.H.; Petersen, B.

    2012-01-01

    Improving the quality of pork and pork products for the consumer: development of innovative, integrated, and sustainable food production chains of high quality pork products matching consumer demands.

  5. Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2010-02-01

    Full Text Available Abstract Background Experts recommend formulating a structured research question to guide the research design. However, the basis for this recommendation has not been formally evaluated. The aim of this study was to examine if a structured research question using the PICOT (Population, Intervention, Comparator, Outcome, Time-frame format is associated with a better reporting quality of randomized controlled trials (RCTs. Methods We evaluated 89 RCTs reports published in three endocrinology journals in 2005 and 2006, the quality of reporting of which was assessed in a previous study. We examined whether the reports stated each of the five elements of a structured research question: population, intervention, comparator, outcome and time-frame. A PICOT score was created with a possible score between 0 and 5. Outcomes were: 1 a 14-point overall reporting quality score (OQS based on the Consolidated Standards for Reporting Trials; and 2 a 3-point key score (KS, based on allocation concealment, blinding and use of intention-to-treat analysis. We conducted multivariable regression analyses using generalized estimating equations to determine if a higher PICOT score or the use of a structured research question were independently associated with a better reporting quality. Journal of publication, funding source and sample size were identified as factors associated with OQS in our previous report on this dataset, and therefore included in the model. Results A higher PICOT score was independently associated with OQS (incidence rate ratio (IRR = 1.021, 95% CI: 1.012 to 1.029 and KS (IRR = 1.142, 95% CI: 1.079 to 1.210. A structured research question was present in 33.7% of the reports and it was associated with a better OQS (IRR = 1.095, 95% CI 1.059-1.132 and KS (IRR = 1.530, 95% CI 1.311-1.786. Conclusions Better framing of the research question using the PICOT format is independently associated with better overall reporting quality - although the effect

  6. A caregiver educational program improves quality of life and burden for cancer patients and their caregivers: a randomised clinical trial.

    Science.gov (United States)

    Belgacem, Bénédicte; Auclair, Candy; Fedor, Marie-Christine; Brugnon, David; Blanquet, Marie; Tournilhac, Olivier; Gerbaud, Laurent

    2013-12-01

    The French setting, including laws and guidelines, advocates greater involvement of informal caregivers in the care of cancer patients to protect the caregivers from depression, distress, and a decrease in their quality of life. This study aimed to assess the efficacy of a caregiver educational programme by measuring two outcomes: patients' and caregivers' quality of life and caregivers' burden. A multicentre randomised controlled trial was performed in six oncology wards in French hospitals. Eligible patients had a cancer, a main caregiver, allowed their caregivers' involvement, and received an inclusion agreement by a doctor/psychologist dyad. The experimental group participated in an educational programme performed by nurses to improve their skills in meal support, nursing care, welfare care, or symptom management. The SF36 and the Zarit burden scales were used to measure quality of life and caregivers' burden at the beginning and at the end of the study. 67 patients were randomised and 33 were included in the experimental group. Evolution scores, which measured the difference between baseline and final scores, showed an improvement in patients' and caregivers' quality of life and an alleviated burden for experimental group caregivers. An educational programme for caregivers encourages the involvement of patients, informal caregivers and health-care providers in a triangular relationship which enhances the quality of life of patients and caregivers alike and decreases caregivers' burden. Care organisation should therefore be rethought as a triangular relationship between patients, caregivers and health-care providers, with nurses as the mainstay. Copyright © 2013 Elsevier Ltd. All rights reserved.

  7. Tailored educational supportive care programme on sleep quality and psychological distress in patients with heart failure: A randomised controlled trial.

    Science.gov (United States)

    Chang, Yia-Ling; Chiou, Ai-Fu; Cheng, Shu-Meng; Lin, Kuan-Chia

    2016-09-01

    Up to 74% of patients with heart failure report poor sleep in Taiwan. Poor symptom management or sleep hygiene may affect patients' sleep quality. An effective educational programme was important to improve patients' sleep quality and psychological distress. However, research related to sleep disturbance in patients with heart failure is limited in Taiwan. To examine the effects of a tailored educational supportive care programme on sleep disturbance and psychological distress in patients with heart failure. randomised controlled trial. Eighty-four patients with heart failure were recruited from an outpatient department of a medical centre in Taipei, Taiwan. Patients were randomly assigned to the intervention group (n=43) or the control group (n=41). Patients in the intervention group received a 12-week tailored educational supportive care programme including individualised education on sleep hygiene, self-care, emotional support through a monthly nursing visit at home, and telephone follow-up counselling every 2 weeks. The control group received routine nursing care. Data were collected at baseline, the 4th, 8th, and 12th weeks after patients' enrollment. Outcome measures included sleep quality, daytime sleepiness, anxiety, and depression. The intervention group exhibited significant improvement in the level of sleep quality and daytime sleepiness after 12 weeks of the supportive nursing care programme, whereas the control group exhibited no significant differences. Anxiety and depression scores were increased significantly in the control group at the 12th week (p.05). Compared with the control group, the intervention group had significantly greater improvement in sleep quality (β=-2.22, pquality and psychological distress in patients with heart failure. We suggested that this supportive nursing care programme should be applied to clinical practice in cardiovascular nursing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. One-year health-related quality of life outcomes in weight loss trial participants: comparison of three measures

    Directory of Open Access Journals (Sweden)

    Kolotkin Ronette L

    2009-06-01

    Full Text Available Abstract Background The literature on changes in health-related quality of life (HRQOL in weight loss studies is inconsistent, and few studies use more than one type of measure. The purpose of the current study was to compare one-year changes in HRQOL as a function of weight change using three different measures: a weight-related measure (Impact of Weight on Quality of Life-Lite [IWQOL-Lite] and two generic measures (SF-36; EQ-5D. Methods Data were obtained from 926 participants (mean Body Mass Index (BMI (kg/m2 = 35.4; 84% female; mean age = 49.5 years in a placebo-controlled randomized trial for weight loss. At baseline and one-year, participants completed all three HRQOL measures. HRQOL was compared across weight change categories (≥ 5% and 0–4.9% gain, 0–4.9%, 5.0–9.9% and ≥ 10% loss, using effect sizes. Results The weight-related measure of HRQOL exhibited greater improvements with one-year weight loss than either of the generic instruments, with effect sizes ranging from 0.24 to 0.62 for 5–9.9% weight reductions and 0.44 to 0.95 for ≥ 10% reductions. IWQOL-Lite Self-Esteem also showed a small improvement with weight gain. Changes in the two generic measures of HRQOL were inconsistent with each other, and in the case of the SF-36, variable across domains. For participants gaining ≥ 5% of weight, the greatest reductions in HRQOL occurred with respect to SF-36 Mental Health, MCS, and Vitality, with effect sizes of -0.82, -0.70, and -0.63 respectively. Conclusion This study found differences between weight-related and generic measures of health-related quality of life in a one-year weight loss trial, reflecting the potential value of using more than one measure in a trial. Although weight loss was generally associated with improved IWQOL-Lite, physical SF-36 subscale and EQ-5D scores, a small amount of weight gain was associated with a slight improvement on weight-specific HRQOL and almost no change on the EQ-5D, suggesting the

  9. EORTC joint ventures in quality control: treatment-related variables and data acquisition in chemotherapy trials.

    Science.gov (United States)

    Vantongelen, K; Steward, W; Blackledge, G; Verweij, J; Van Oosterom, A

    1991-01-01

    In multicentre studies, non-compliance with the protocol may limit the chances of reaching a correct conclusion. A procedure to examine the administration of chemotherapy in multicentre EORTC protocols has been developed. General aspects are covered in a mailed questionnaire on the prescription of drugs with rounding up or down of dosages, local facilities for preparation and the procedure for preparation and administration. More detail is collected during a quality control site visit. Ten centres have been visited and there was significant variation between centres in the organisation of chemotherapy administration. However, more striking differences were noted between the type and quality of hospital files. The lack of systematic recording of sequence, timing and doses of chemotherapy and, in particular, treatment related toxicity, is a major difficulty limiting the effectiveness of quality control. These shortcomings emphasise the need for standardisation of some aspects of case records and a suggested check-list has been drafted.

  10. High Yield Chemical Vapor Deposition Growth of High Quality Large-Area AB Stacked Bilayer Graphene

    Science.gov (United States)

    Liu, Lixin; Zhou, Hailong; Cheng, Rui; Yu, Woo Jong; Liu, Yuan; Chen, Yu; Shaw, Jonathan; Zhong, Xing; Huang, Yu; Duan, Xiangfeng

    2012-01-01

    Bernal stacked (AB stacked) bilayer graphene is of significant interest for functional electronic and photonic devices due to the feasibility to continuously tune its band gap with a vertical electrical field. Mechanical exfoliation can be used to produce AB stacked bilayer graphene flakes but typically with the sizes limited to a few micrometers. Chemical vapor deposition (CVD) has been recently explored for the synthesis of bilayer graphene but usually with limited coverage and a mixture of AB and randomly stacked structures. Herein we report a rational approach to produce large-area high quality AB stacked bilayer graphene. We show that the self-limiting effect of graphene growth on Cu foil can be broken by using a high H2/CH4 ratio in a low pressure CVD process to enable the continued growth of bilayer graphene. A high temperature and low pressure nucleation step is found to be critical for the formation of bilayer graphene nuclei with high AB stacking ratio. A rational design of a two-step CVD process is developed for the growth of bilayer graphene with high AB stacking ratio (up to 90 %) and high coverage (up to 99 %). The electrical transport studies demonstrated that devices made of the as-grown bilayer graphene exhibit typical characteristics of AB stacked bilayer graphene with the highest carrier mobility exceeding 4,000 cm2/V·s at room temperature, comparable to that of the exfoliated bilayer graphene. PMID:22906199

  11. The Effects of Aromatherapy on Intensive Care Unit Patients' Stress and Sleep Quality: A Nonrandomised Controlled Trial

    Science.gov (United States)

    Cho, Eun Hee; Lee, Mi-Young

    2017-01-01

    Background Stress has both physiological and psychological effects and can negatively impact patients' treatment and recovery. We examined whether the aromatherapy alleviated patients' stress and improved their sleep quality and provided data that can be utilized in clinical settings. Methods This was a nonrandomised controlled experimental study. Participants included lucid adult patients who were admitted to the intensive care unit and had spent more than two nights there. The experimental treatment required participants to engage in deep breathing with essential oils as part of the aromatherapy. The control group was instructed to go to sleep without receiving the lavender aroma oil. Results The experimental group and control group showed a significant difference in perceived stress (F = 60.11, p aromatherapy alleviated stress and improved sleep quality in intensive care unit patients after 2 days of the experimental treatment. These results demonstrate that aromatherapy affects stress and sleep quality, thus indicating its value in nursing interventions. This trial is registered with KCT0002344. PMID:29375641

  12. A randomized controlled trial of Tai chi for balance, sleep quality and cognitive performance in elderly Vietnamese

    Directory of Open Access Journals (Sweden)

    Nguyen MH

    2012-06-01

    Full Text Available Manh Hung Nguyen, Andreas KruseInstitute of Gerontology, Heidelberg University, Heidelberg, GermanyObjective: To evaluate the effects of Tai chi exercise on balance, sleep quality, and cognitive performance in community-dwelling elderly in Vinh city, Vietnam.Design: A randomized controlled trial.Participants: One hundred two subjects were recruited.Intervention: Subjects were divided randomly into two groups. The Tai chi group was assigned 6 months' Tai chi training. The control group was instructed to maintain their routine daily activities.Outcome measures: The Falls Efficacy Scale (FES, Pittsburgh Sleep Quality Index (PSQI, and Trail Making Test (TMT were used as primary outcome measures.Results: Participants in the Tai chi group reported significant improvement in TMT (part A (F [1, 71] = 78.37, P < 0.001 and in TMT (part B, (F [1, 71] = 175.00, P < 0.001 in comparison with the control group. Tai chi participants also reported better scores in FES (F [1, 71] = 96.90, P < 0.001 and in PSQI (F [1,71] = 43.69, P = 0.001 than the control group.Conclusion: Tai chi is beneficial to improve balance, sleep quality, and cognitive performance of the elderly.Keywords: Tai chi, sleep, balance 

  13. Evaluating the impact of continuous quality improvement methods at hospitals in Tanzania: a cluster-randomized trial.

    Science.gov (United States)

    Kamiya, Yusuke; Ishijma, Hisahiro; Hagiwara, Akiko; Takahashi, Shizu; Ngonyani, Henook A M; Samky, Eleuter

    2017-02-01

    To evaluate the impact of implementing continuous quality improvement (CQI) methods on patient's experiences and satisfaction in Tanzania. Cluster-randomized trial, which randomly allocated district-level hospitals into treatment group and control group, was conducted. Sixteen district-level hospitals in Kilimanjaro and Manyara regions of Tanzania. Outpatient exit surveys targeting totally 3292 individuals, 1688 in the treatment and 1604 in the control group, from 3 time-points between September 2011 and September 2012. Implementation of the 5S (Sort, Set, Shine, Standardize, Sustain) approach as a CQI method at outpatient departments over 12 months. Cleanliness, waiting time, patient's experience, patient's satisfaction. The 5S increased cleanliness in the outpatient department, patients' subjective waiting time and overall satisfaction. However, negligible effects were confirmed for patient's experiences on hospital staff behaviours. The 5S as a CQI method is effective in enhancing hospital environment and service delivery; that are subjectively assessed by outpatients even during the short intervention period. Nevertheless, continuous efforts will be needed to connect CQI practices with the further improvement in the delivery of quality health care. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  14. Effects of music and music video interventions on sleep quality: A randomized controlled trial in adults with sleep disturbances.

    Science.gov (United States)

    Huang, Chiung-Yu; Chang, En-Ting; Hsieh, Yuan-Mei; Lai, Hui-Ling

    2017-10-01

    The present study aimed to compare the effects of music and music video interventions on objective and subjective sleep quality in adults with sleep disturbances. A randomized controlled trial was performed on 71 adults who were recruited from the outpatient department of a hospital with 1100 beds and randomly assigned to the control, music, and music video groups. During the 4 test days (Days 2-5), for 30min before nocturnal sleep, the music group listened to Buddhist music and the music video group watched Buddhist music videos. They were instructed to not listen/watch to the music/MV on the first night (pretest, Day 1) and the final night (Day 6). The control group received no intervention. Sleep was assessed using a one-channel electroencephalography machine in their homes and self-reported questionnaires. The music and music video interventions had no effect on any objective sleep parameters, as measured using electroencephalography. However, the music group had significantly longer subjective total sleep time than the music video group did (Wald χ 2 =6.23, p=0.04). Our study results increase knowledge regarding music interventions for sleep quality in adults with sleep disturbances. This study suggested that more research is required to strengthen the scientific knowledge of the effects of music intervention on sleep quality in adults with sleep disturbances. (ISRCTN94971645). Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. The effect of melatonin on sleep quality after laparoscopic cholecystectomy: a randomized, placebo-controlled trial

    DEFF Research Database (Denmark)

    Gögenur, Ismail; Kücükakin, Bülent; Bisgaard, Thue

    2009-01-01

    = 60) or placebo (n = 61) for 3 nights after surgery. Subjective sleep quality, sleep duration, sleep timing, and subjective discomfort (fatigue, general well-being, and pain) were measured. RESULTS: Sleep latency was significantly reduced in the melatonin group (mean [sd] 14 min [18]) compared...... with placebo (28 min [41]) on the first postoperative night (P = 0.015). The rest of the measured outcome variables did not differ between groups. CONCLUSIONS: Melatonin did not improve subjective sleep quality or discomfort compared with placebo after laparoscopic cholecystectomy....

  16. The quality of life among first-episode psychotic patients in the OPUS trial

    DEFF Research Database (Denmark)

    Thorup, Anne; Petersen, Lone; Jeppesen, Pia

    2010-01-01

    BACKGROUND: From an 'objective' perspective, treatment of first-episode psychosis has improved in many ways with the development of specialised early and intensive team-based treatment like e.g. the 'OPUS' treatment. However, the patients' perspective is also important and was investigated in the...... extent and more strongly with the affective balance and level of self-esteem....... in the 'OPUS' study by analysing data concerning quality of life. AIM: We aimed to investigate the 'quality of life from patients' perspective' among a cohort of young adults with a first-episode psychosis at the time of treatment initiation and after two years. Especially, we were interested in analysing...

  17. A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

    Directory of Open Access Journals (Sweden)

    Norrie John

    2010-04-01

    Full Text Available Abstract Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676

  18. Quality assurance of the PREOPANC trial (2012-003181-40) for preoperative radiochemotherapy in pancreatic cancer. The dummy run

    Energy Technology Data Exchange (ETDEWEB)

    Versteijne, Eva; Lens, Eelco; Horst, Astrid van der; Bel, Arjan; Visser, Jorrit; Tienhoven, Geertjan van [Academic Medical Center, University of Amsterdam, Department of Radiation Oncology, Amsterdam (Netherlands); Punt, Cornelis J.A. [Academic Medical Center, University of Amsterdam, Department of Medical Oncology, Amsterdam (Netherlands); Suker, Mustafa; Eijck, Casper H.J. van [Erasmus Medical Center, Erasmus University, Department of Surgery, Rotterdam (Netherlands)

    2017-08-15

    The Dutch Pancreatic Cancer Group initiated the national, multicentre, controlled PREOPANC trial, randomising between preoperative radiochemotherapy and direct explorative laparotomy for patients with (borderline) resectable pancreatic cancer. The aim of this dummy run is to evaluate compliance with the radiotherapy protocol of this trial, and the quality of delineation and radiation plans. Eleven radiation oncology departments open for accrual of patients in the PREOPANC trial were provided with all necessary information of a selected 'dummy' patient. Each institute was asked to delineate the target volumes, including gross tumour volume, internal gross tumour volume (iGTV), internal clinical target volume, and planning target volume. The institutions were also asked to provide a radiation treatment plan in accordance with the PREOPANC trial protocol. The range of the iGTV was 19.3-77.2 cm{sup 3} with a mean iGTV of 41.5 cm{sup 3} (standard deviation 14.8 cm{sup 3}). Nine institutions made a treatment plan using an arc technique for treatment delivery, one an intensity modulated technique and one a 3-field conformal technique. All institutions reached the prescribed target coverage, without exceeding the organs at risk constraints. The institution with the 3-field conformal technique was advised to use a more sophisticated technique (e. g. volumetric modulated arc therapy) to reduce the dose to the spinal cord. All institutions showed acceptable deviations from the PREOPANC trial protocol and achieved an acceptable quality of delineation and radiation technique. All institutions were allowed to continue participation in the PREOPANC trial. (orig.) [German] Die niederlaendische Gruppe fuer Bauchspeicheldruesenkrebs (Dutch Pancreatic Cancer Group, DPCG) initiierte die nationale und multizentral kontrollierte PREOPANC-Studie, worin die praeoperative Radiochemotherapie mit der direkten explorativen Laparotomie fuer Patienten mit (grenzwertig) resektablen

  19. BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301)

    International Nuclear Information System (INIS)

    Hayne, Dickon; Stockler, Martin; McCombie, Steve P.; Chalasani, Venu; Long, Anne; Martin, Andrew; Sengupta, Shomik; Davis, Ian D.

    2015-01-01

    Despite adequate trans-urethral resection of the bladder tumour (TURBT), non-muscle-invasive bladder cancer (NMIBC) is associated with high rates of recurrence and progression. Instillation of Bacillus Calmette-Guérin (BCG) into the urinary bladder after TURBT (adjuvant intravesical administration) reduces the risk of both recurrence and progression, and this is therefore the standard of care for high-risk tumours. However, over 30 % of people still recur or progress despite optimal delivery of BCG. Our meta-analysis suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both mitomycin and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase III trial using standard techniques for intravesical administration. The BCG + MMC trial (ANZUP 1301) is an open-label, randomised, stratified, two-arm multi-centre phase III trial comparing the efficacy and safety of standard intravesical therapy (BCG alone) against experimental intravesical therapy (BCG and mitomycin) in the treatment of adults with resected, high-risk NMIBC. Participants in the control group receive standard treatment with induction (weekly BCG for six weeks) followed by maintenance (four-weekly BCG for ten months). Participants in the experimental group receive induction (BCG weeks 1, 2, 4, 5, 7, and 8; mitomycin weeks 3, 6, and 9) followed by four-weekly maintenance (mitomycin weeks 13, 17, 25, 29, 37, and 41; BCG weeks 21, 33, and 45). The trial aims to include 500 participants who will be centrally randomised to one of the two treatment groups in a 1:1 ratio stratified by T-stage, presence of CIS, and study site. The primary endpoint is disease-free survival; secondary endpoints are disease activity, time to recurrence, time to progression, safety, health-related quality of life, overall survival, feasibility, and resource use

  20. Consumers' expected quality and intention to purchase high quality pork meat.

    Science.gov (United States)

    Papanagiotou, P; Tzimitra-Kalogianni, I; Melfou, K

    2013-03-01

    Expected quality is believed to be one of the most important factors that influence consumers' intention to purchase food. The present study seeks to explore the concept of pork meat expected quality and compare it with self-stated consumer intention to purchase pork meat. The aim is attempted by means of a field research conducted in Greece, following a conjoint analytic procedure. Results show that quality expectations comply with intention to buy pork, in many aspects. However, several differences have been identified. More specifically, country of origin and marbling appear to be more important for respondents' purchase decisions than they are for their quality evaluations, while the opposite appears to be true for price. Finally, socio-demographic factors such as gender, level of education, place of purchase and consumption habits seem to influence perceptions. Copyright © 2012 Elsevier Ltd. All rights reserved.

  1. Additive Effects of Word Frequency and Stimulus Quality: The Influence of Trial History and Data Transformations

    Science.gov (United States)

    Balota, David A.; Aschenbrenner, Andrew J.; Yap, Melvin J.

    2013-01-01

    A counterintuitive and theoretically important pattern of results in the visual word recognition literature is that both word frequency and stimulus quality produce large but additive effects in lexical decision performance. The additive nature of these effects has recently been called into question by Masson and Kliegl (in press), who used linear…

  2. Pain severity reduces life quality in chronic pancreatitis: Implications for design of future outcome trials

    NARCIS (Netherlands)

    Olesen, S.S.; Juel, J.; Nielsen, A.K.; Frokjaer, J.B.; Wilder-Smith, O.H.G.; Drewes, A.M.

    2014-01-01

    BACKGROUND/OBJECTIVES: Chronic pancreatitis (CP) is a disabling disease characterised by abdominal pain, and various pancreatic and extra-pancreatic complications. We investigated the interactions between pain characteristics (i.e. pain severity and its pattern in time), complications, and quality

  3. Targeting cancer patients' quality of life through social comparison : A randomised trial

    NARCIS (Netherlands)

    Brakel, Thecla M.; Dijkstra, Arie; Buunk, Abraham P.

    2014-01-01

    Objective: Former cancer patients' quality of life can be improved by offering social comparison information. Whether patients, however, benefit from the information may depend on how negative they perceive their present and their future. Design: We conducted a randomised experimental field study

  4. Safe and High Quality Food Production using Low Quality Waters and Improved Irrigation Systems and Management, EU Project

    DEFF Research Database (Denmark)

    Plauborg, Finn; Jensen, Christian Richardt; Dalsgaard, Anders

    2009-01-01

    : the safety and quality of food products, and the increasing competition for clean freshwater. SAFIR is funded for the period 2005-2009 under the Food Quality and Safety thematic area of the EU 6th Framework Research Programme. The challenge for the next years will be to produce safe and high quality foods...... a multi-disciplinary team, with food safety and quality experts, engineers, agronomists and economists from17 research institutes and private companies in Europe, Israel and China working together. The project assesses potential risks to farmers. Coupled with farm management and economic models, a new...... intelligent tool for efficient and safe use and re-use of low-quality water are being developed. Already published results indicate water saving in the order of 25-30% in agricultural crops as potatoes and tomatoes are possible without yield reduction. Slightly treated waste water can be used safely when...

  5. Implementation of Remote 3-Dimensional Image Guided Radiation Therapy Quality Assurance for Radiation Therapy Oncology Group Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Cui Yunfeng [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States); Parker, William [Department of Medical Physics, McGill University Health Center, Montreal, QC (Canada); Breen, Stephen [Department of Radiation Physics, Princess Margaret Hospital, Toronto, ON (Canada); Yin Fangfang; Cai Jing [Department of Radiation Oncology, Duke University Medical Center, Durham, North Carolina (United States); Papiez, Lech S. [Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas (United States); Li, X. Allen [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States); Bednarz, Greg [Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (United States); Chen Wenzhou [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Xiao Ying, E-mail: ying.xiao@jefferson.edu [Department of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania (United States)

    2013-01-01

    Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as part of QA

  6. Mental health first aid training for high school teachers: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Jorm Anthony F

    2010-06-01

    Full Text Available Abstract Background Mental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial. Methods The trial was carried out with teachers in South Australian high schools. Teachers at 7 schools received training and those at another 7 were wait-listed for future training. The effects of the training on teachers were evaluated using questionnaires pre- and post-training and at 6 months follow-up. The questionnaires assessed mental health knowledge, stigmatizing attitudes, confidence in providing help to others, help actually provided, school policy and procedures, and teacher mental health. The indirect effects on students were evaluated using questionnaires at pre-training and at follow-up which assessed any mental health help and information received from school staff, and also the mental health of the student. Results The training increased teachers' knowledge, changed beliefs about treatment to be more like those of mental health professionals, reduced some aspects of stigma, and increased confidence in providing help to students and colleagues. There was an indirect effect on students, who reported receiving more mental health information from school staff. Most of the changes found were sustained 6 months after training. However, no effects were found on teachers' individual support towards students with mental health problems or on student mental health. Conclusions Mental Health First Aid training has positive effects on teachers' mental health knowledge, attitudes, confidence and some aspects of their behaviour. Trial registration ACTRN12608000561381

  7. Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.

    Science.gov (United States)

    Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G

    2016-06-01

    Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.

  8. A randomized controlled clinical trial evaluating quality of life when using a simple acupressure protocol in women with primary dysmenorrhea.

    Science.gov (United States)

    Bazarganipour, Fatemeh; Taghavi, Seyed-Abdolvahab; Allan, Helen; Hosseini, Nazafarin; Khosravi, Ahmad; Asadi, Rahimeh; Salari, Shohreh; Dehghani, Raziyeh; Jamshidi, Zahra; Rezaei, Marziyeh; Saberian, Mansoreh; Javedan, Fatemeh; Salari, Zahra; Miri, Fahimeh

    2017-10-01

    To evaluate a simple acupressure protocol in LIV3 and LI4 acupoints in women with primary dysmenorrhea. This paper reports a randomized, single blinded clinical trial. 90 young women with dysmenorrhea were recruited to three groups to receive 20min acupressure every day in either LIV3 or LI4, or placebo points. Acupressure was timed five days before menstruation for three successive menstrual cycles. On menstruation, each participant completed the Wong Baker faces pain scale, and the quality of life short form -12 (QOL SF-12). Intensity and duration of pain between the three groups in the second and third cycles during the intervention (pdysmenorrhea, and improve the QOL. Registration ID in IRCT: IRCT2016052428038N1. Copyright © 2017. Published by Elsevier Ltd.

  9. Quality of life, fatigue and local response of patients with unstable spinal bone metastases under radiation therapy - a prospective trial

    International Nuclear Information System (INIS)

    Rief, Harald; Heinhold, Maximiliane; Bruckner, Thomas; Schlampp, Ingmar; Förster, Robert; Welzel, Thomas; Bostel, Tilman; Debus, Jürgen; Rieken, Stefan

    2014-01-01

    To evaluate the local response according to stability after radiotherapy (RT) with a special focus on quality-of-life (QoL), fatigue, pain and emotional distress in patients with unstable spinal bone metastases. In this prospective trial, 30 patients were treated from September 2011 until March 2013. The stability of osteolytic metastases in the thoracic and lumbar spine was evaluated on the basis of the Taneichi-score after three and six months. EORTC QLQ-BM22, EORTC QLQ-FA13, and QSC-R10 were assessed at baseline, and three months after RT. After 3 months, 25% (n = 6) and after 6 months 33.3% (n = 8) were classified as stable. QoL, fatigue, and emotional distress showed no difference over the course. The pain response 3 months after RT showed a significant difference (p < 0.001). Pathological fractures occurred in 8.3% of the patients (n = 2) within six months following RT. Our trial demonstrated that RT can improve stability in one third of patients over a 6-months period with unstable spinal metastases. Importantly, for these patients pain relief was detected but RT had no impact on QoL, fatigue, and emotional distress

  10. Changing core beliefs with trial-based cognitive therapy may improve quality of life in social phobia: a randomized study

    Directory of Open Access Journals (Sweden)

    Vania Bitencourt Powell

    2013-09-01

    Full Text Available Objective: To determine whether there are differences in quality of life (QoL improvement after treatment with the trial-based thought record (TBTR versus conventional cognitive therapy (CCT in patients with social anxiety disorder (SAD. Method: A randomized trial comparing TBTR with a set of CCT techniques, which included the standard 7-column dysfunctional thought record (DTR and the positive data log (PDL in patients with SAD, generalized type. Results: Repeated measures analysis of variance (ANOVA revealed a significant time effect in the general health, vitality, social functioning, and mental health domains of the Short Form 36. It also indicated significant treatment effects on the bodily pain, social functioning, role-emotional, and mental health domains, with higher scores in the TBTR group. One-way analysis of covariance (ANCOVA, using pretreatment values as covariates, showed that TBTR was associated with significantly better QoL post-treatment (bodily pain, social functioning and role-emotional and at follow-up (role-emotional. A significant treatment effect on the role-emotional domain at 12-month follow-up denoted a sustained effect of TBTR relative to CCT. Conclusion: This study provided preliminary evidence that TBTR is at least as effective as CCT in improving several domains of QoL in SAD, specifically when the standard 7-column DTR and the PDL are used.

  11. Changing core beliefs with trial-based cognitive therapy may improve quality of life in social phobia: a randomized study.

    Science.gov (United States)

    Powell, Vania Bitencourt; Oliveira, Olivia Haun de; Seixas, Camila; Almeida, Cláudia; Grangeon, Maria Conceição; Caldas, Milke; Bonfim, Thaís Delavechia; Castro, Martha; Galvão-de Almeida, Amanda; Galvão-de Almeida; Moraes, Roberta de Oliveira; Sudak, Donna; de-Oliveira, Irismar Reis

    2013-01-01

    To determine whether there are differences in quality of life (QoL) improvement after treatment with the trial-based thought record (TBTR) versus conventional cognitive therapy (CCT) in patients with social anxiety disorder (SAD). A randomized trial comparing TBTR with a set of CCT techniques, which included the standard 7-column dysfunctional thought record (DTR) and the positive data log (PDL) in patients with SAD, generalized type. Repeated measures analysis of variance (ANOVA) revealed a significant time effect in the general health, vitality, social functioning, and mental health domains of the Short Form 36. It also indicated significant treatment effects on the bodily pain, social functioning, role-emotional, and mental health domains, with higher scores in the TBTR group. One-way analysis of covariance (ANCOVA), using pretreatment values as covariates, showed that TBTR was associated with significantly better QoL post-treatment (bodily pain, social functioning and role-emotional) and at follow-up (role-emotional). A significant treatment effect on the role-emotional domain at 12-month follow-up denoted a sustained effect of TBTR relative to CCT. This study provided preliminary evidence that TBTR is at least as effective as CCT in improving several domains of QoL in SAD, specifically when the standard 7-column DTR and the PDL are used.

  12. Clinical Trials

    Medline Plus

    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A ...

  13. A double-blind, placebo controlled trial of high-dose lecithin in Alzheimer's disease.

    OpenAIRE

    Little, A; Levy, R; Chuaqui-Kidd, P; Hand, D

    1985-01-01

    The first long-term double-blind placebo controlled trial of high dose lecithin in senile dementia of the Alzheimer type is reported. Fifty one subjects were given 20-25 g/day of purified soya lecithin (containing 90% phosphatidyl plus lysophosphatidyl choline) for six months and followed up for at least a further six months. Plasma choline levels were monitored throughout the treatment period. There were no differences between the placebo group and the lecithin group but there was an improve...

  14. HIGH QUALITY ENVIRONMENTAL PRINCIPLES APPLIED TO THE ARCHITECTONIC DESIGN SELECTION PROCEDURE: THE NUTRE LAB CASE

    Directory of Open Access Journals (Sweden)

    Claudia Barroso Krause

    2012-06-01

    Full Text Available The need to produce more sustainable buildings has been influencing the design decisions all over the world. That’s why it is imperative, in Brazil, the development of strategies and method to aid the decision making during the design process, focused on high quality environmental. This paper presents a decision support tool based on the principles of sustainable construction developed by the Project, Architecture and Sustainability Research Group (GPAS of Federal University of Rio de Janeiro – Brazil. The methodology has been developed for the selection of a preliminary design of a laboratory to be built at Rio Technology Park at the University campus. The support provided by GPAS occurred in three stages: the elaboration of the Reference Guide for the competitors, the development of a methodology to evaluate the proposed solutions (based on environmental performance criteria and the assistance of the members of jury in the trial phase. The theoretical framework was based upon the concepts of the bioclimatic architecture, the procedures specified by the certification HQE® (Haute Qualité Environnementale and the method suggested by the ADDENDA® architecture office. The success of this experience points out the possibility to future application in similar cases.

  15. The effects of radiation therapy on quality of life in women with breast cancer: Results of a randomized trial

    International Nuclear Information System (INIS)

    Whelan, T.; Levine, M.; Julian, J.; Skingley, P.; Kirkbride, P.; Clark, R.; Lipa, M.; Wilkinson, R.

    1997-01-01

    Purpose/Objective: The effects of radiation therapy on quality of life of women with breast cancer are not well known. The purpose of this study was to evaluate the effect of breast irradiation on quality of life including cosmetic outcome in the context of a randomized controlled trial. Methods: Between 1984 and 1989 a randomized trial was conducted in Ontario in which women with node-negative breast cancer who had undergone lumpectomy and axillary section were randomized either to postoperative radiation (4000 cGy in 16 fractions to the whole breast, followed by a boost of 1250 cGy in five fractions to the primary site) or no further treatment (J Natl Cancer Inst 1996; 88:1659). A modified version of the breast cancer chemotherapy questionnaire (J Clin Oncol 1988; 6:1798) containing 17 items was administered to women at baseline, one month and two months postrandomization. Each item was scored on a Likert scale from ''1'' All of the Time to ''7'' None of the Time. Patient assessments of breast pain and cosmetic outcome were also evaluated every three months for the first two years of the study. Results: Of 837 patients, 416 were randomly allocated to radiation therapy and 421 to no further treatment. The groups were comparable in terms of baseline characteristics. Factor analysis identified three different domains of the quality of life instrument: emotional/social, fatigue, and physical/inconvenience. There was a significant difference in the physical/inconvenience and fatigue domain scores between the radiation and control groups over time. The differences in scores between groups at two months post randomization were 0.97, p = 0.0001; 0.33, p=0.0001; and 0.03, p=0.62 for the physical/inconvenience, fatigue and emotional/social domains respectively. The percentage of patients who were troubled by breast pain differed between radiation and control groups up to one year (33.3% vs 19.9%, p = 0.001 at 6 months). Beyond one year, no difference was detected. The

  16. Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial.

    Science.gov (United States)

    Sancho, Aintzane; Carrera, Sergio; Arietaleanizbeascoa, Marisol; Arce, Veronica; Gallastegui, Nere Mendizabal; Giné March, Anna; Sanz-Guinea, Aitor; Eskisabel, Araceli; Rodriguez, Ana Lopez; Martín, Rosa A; Lopez-Vivanco, Guillermo; Grandes, Gonzalo

    2015-02-06

    The optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time. We will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time

  17. Quality assessment and potential utilization of high amylolytic ...

    African Journals Online (AJOL)

    STORAGESEVER

    2008-12-03

    Dec 3, 2008 ... This study was carried out to compare the qualities of two acclaimed Nigerian amylolytic maize cultivars; SPMAT ... growing demand for usage as a gluten-free cereal. (Sweeny ... The grain was malted and the malting loss was calculated using the .... also confirmed that there was no significant difference in.

  18. Quality Alternative Certification Programs in Special Education Ensure High Retention

    Science.gov (United States)

    Karge, Belinda D.; McCabe, Marjorie

    2014-01-01

    Market driven alternative routes to teaching have evolved into a quality program option and not just an answer to the teacher shortage. Alternative certification is a viable means of recruiting, training, and certifying those who have a bachelor's degree and a strong desire to enter the field of teaching. California has been a leader in the…

  19. Innovation in Business Education: Developing a High Quality Online MBA

    Science.gov (United States)

    Roe, C. William; Toma, Alfred G.; Yallapragada, RamMohan R.

    2015-01-01

    Online degree programs were probably pioneered by for-profit universities such as University of Phoenix. Many online degree programs were initially considered low quality academic programs compared to traditional programs. Therefore, many public and private universities were slow to adopt the online programs. However, gradually more and more…

  20. Effect of e-Learning and Repeated Performance Feedback on Spirometry Test Quality in Family Practice: A Cluster Trial

    Science.gov (United States)

    Schermer, Tjard R.; Akkermans, Reinier P.; Crockett, Alan J.; van Montfort, Marian; Grootens-Stekelenburg, Joke; Stout, Jim W.; Pieters, Willem

    2011-01-01

    PURPOSE Spirometry has become an indispensable tool in primary care to exclude, diagnose, and monitor chronic respiratory conditions, but the quality of spirometry tests in family practices is a reason for concern. Aim of this study was to investigate whether a combination of e-learning and bimonthly performance feedback would improve spirometry test quality in family practices in the course of 1 year. METHODS Our study was a cluster trial with 19 family practices allocated to intervention or control conditions through minimization. Intervention consisted of e-learning and bimonthly feedback reports to practice nurses. Control practices received only the joint baseline workshop. Spirometry quality was assessed by independent lung function technicians. Two outcomes were defined, with the difference between rates of tests with 2 acceptable and repeatable blows being the primary outcome and the difference between rates of tests with 2 acceptable blows being the secondary outcome. We used multilevel logistic regression analysis to calculate odds ratios (ORs) for an adequate test in intervention group practices. RESULTS We analyzed 1,135 tests. Rate of adequate tests was 33% in intervention and 30% in control group practices (OR = 1.3; P=.605). Adequacy of tests did not differ between groups but tended to increase with time: OR = 2.2 (P = .057) after 3 and OR = 2.0 (P = .086) in intervention group practices after 4 feedback reports. When ignoring test repeatability, these differences between the groups were slightly more pronounced: OR = 2.4 (P = .033) after 3 and OR=2.2 (P = .051) after 4 feedback reports. CONCLUSIONS In the course of 1 year, we observed a small and late effect of e-learning and repeated feedback on the quality of spirometry as performed by family practice nurses. This intervention does not seem to compensate the lack of rigorous training and experience in performing spirometry tests in most practices. PMID:21747104

  1. Time to improvement of pain and sleep quality in clinical trials of pregabalin for the treatment of fibromyalgia.

    Science.gov (United States)

    Arnold, Lesley M; Emir, Birol; Pauer, Lynne; Resnick, Malca; Clair, Andrew

    2015-01-01

    To determine the time to immediate and sustained clinical improvement in pain and sleep quality with pregabalin in patients with fibromyalgia. A post hoc analysis of four 8- to 14-week phase 2-3, placebo-controlled trials of fixed-dose pregabalin (150-600 mg/day) for fibromyalgia, comprising 12 pregabalin and four placebo treatment arms. A total of 2,747 patients with fibromyalgia, aged 18-82 years. Pain and sleep quality scores, recorded daily on 11-point numeric rating scales (NRSs), were analyzed to determine time to immediate improvement with pregabalin, defined as the first of ≥2 consecutive days when the mean NRS score was significantly lower for pregabalin vs placebo in those treatment arms with a significant improvement at endpoint, and time to sustained clinical improvement with pregabalin, defined as a ≥1-point reduction of the baseline NRS score of patient responders who had a ≥30% improvement on the pain NRS, sleep NRS, or Fibromyalgia Impact Questionnaire (FIQ) from baseline to endpoint, or who reported "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC) at endpoint. Significant improvements in pain and sleep quality scores at endpoint vs placebo were seen in 8/12 and 11/12 pregabalin treatment arms, respectively (P < 0.05). In these arms, time to immediate improvements in pain or sleep occurred by day 1 or 2. Time to sustained clinical improvement occurred significantly earlier in pain, sleep, PGIC, and FIQ responders (P < 0.02) with pregabalin vs placebo. Both immediate and sustained clinical improvements in pain and sleep quality occurred faster with pregabalin vs placebo. Wiley Periodicals, Inc.

  2. Quality of recovery from anesthesia of patients undergoing balanced or total intravenous general anesthesia. Prospective randomized clinical trial.

    Science.gov (United States)

    Moro, Eduardo Toshiyuki; Leme, Fábio Caetano Oliveira; Noronha, Bernardo Roveda; Saraiva, Gustavo Farinha Pinto; de Matos Leite, Nathália Vianna; Navarro, Laís Helena Camacho

    2016-12-01

    The aim of the present study was to assess the quality of recovery from anesthesia of patients subjected to otorhinolaryngological (ORL) surgery under balanced or total intravenous general anesthesia by means of Quality of Recovery-40 (QoR-40) questionnaire. Prospective randomized clinical trial. The setting is at an operating room, a postoperative recovery area, and a hospital ward. One-hundred thirty American Society of Anesthesiologists physical status I or II patients scheduled to undergo general anesthesia for ORL interventions under remifentanil, in combination with sevoflurane (balanced technique) or propofol (total intravenous anesthesia). Occurrence of nausea, vomiting, body temperature less than 36°C, and length of stay in the postanesthesia care unit were recorded. The QoR-40 was administered by an investigator blind to group allocation 24 hours after surgery. The quality of recovery, as assessed by the score on the QoR-40, was compared between the groups. There is no difference regarding the QoR-40 score among intravenous and inhalation anesthesia groups (190.5 vs 189.5, respectively; P=.33). Similarly, among the 5 dimensions of the QoR-40, the scores were comparable between the groups. Incidence of hypothermia (P=.58), nauseas or vomits (P=.39), and length of surgery (P=.16) were similar among groups. The evaluation of pain intensity (P=.80) and dose of morphine use in the postanesthesia care unit (P=.4) was also comparable between groups. The quality of recovery from anesthesia assessed based on the patients' perception did not differ between the ones subjected to either inhalation or intravenous general anesthesia for ORL surgery based on QoR-40 questionnaire assessment. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Effect of e-learning and repeated performance feedback on spirometry test quality in family practice: a cluster trial.

    Science.gov (United States)

    Schermer, Tjard R; Akkermans, Reinier P; Crockett, Alan J; van Montfort, Marian; Grootens-Stekelenburg, Joke; Stout, Jim W; Pieters, Willem

    2011-01-01

    Spirometry has become an indispensable tool in primary care to exclude, diagnose, and monitor chronic respiratory conditions, but the quality of spirometry tests in family practices is a reason for concern. Aim of this study was to investigate whether a combination of e-learning and bimonthly performance feedback would improve spirometry test quality in family practices in the course of 1 year. Our study was a cluster trial with 19 family practices allocated to intervention or control conditions through minimization. Intervention consisted of e-learning and bimonthly feedback reports to practice nurses. Control practices received only the joint baseline workshop. Spirometry quality was assessed by independent lung function technicians. Two outcomes were defined, with the difference between rates of tests with 2 acceptable and repeatable blows being the primary outcome and the difference between rates of tests with 2 acceptable blows being the secondary outcome. We used multilevel logistic regression analysis to calculate odds ratios (ORs) for an adequate test in intervention group practices. We analyzed 1,135 tests. Rate of adequate tests was 33% in intervention and 30% in control group practices (OR = 1.3; P=.605). Adequacy of tests did not differ between groups but tended to increase with time: OR = 2.2 (P = .057) after 3 and OR = 2.0 (P = .086) in intervention group practices after 4 feedback reports. When ignoring test repeatability, these differences between the groups were slightly more pronounced: OR = 2.4 (P = .033) after 3 and OR=2.2 (P = .051) after 4 feedback reports. In the course of 1 year, we observed a small and late effect of e-learning and repeated feedback on the quality of spirometry as performed by family practice nurses. This intervention does not seem to compensate the lack of rigorous training and experience in performing spirometry tests in most practices.

  4. Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials.

    Science.gov (United States)

    Teleni, Laisa; Chan, Raymond J; Chan, Alexandre; Isenring, Elisabeth A; Vela, Ian; Inder, Warrick J; McCarthy, Alexandra L

    2016-02-01

    Men receiving androgen deprivation therapy (ADT) for prostate cancer (PCa) are likely to develop metabolic conditions such as diabetes, cardiovascular disease, abdominal obesity and osteoporosis. Other treatment-related side effects adversely influence quality of life (QoL) including vasomotor distress, depression, anxiety, mood swings, poor sleep quality and compromised sexual function. The objective of this study was to systematically review the nature and effects of dietary and exercise interventions on QoL, androgen deprivation symptoms and metabolic risk factors in men with PCa undergoing ADT. An electronic search of CINAHL, CENTRAL, Medline, PsychINFO and reference lists was performed to identify peer-reviewed articles published between January 2004 and December 2014 in English. Eligible study designs included randomised controlled trials (RCTs) with pre- and post-intervention data. Data extraction and assessment of methodological quality with the Cochrane approach was conducted by two independent reviewers. Seven exercise studies were identified. Exercise significantly improved QoL, but showed no effect on metabolic risk factors (weight, waist circumference, lean or fat mass, blood pressure and lipid profile). Two dietary studies were identified, both of which tested soy supplements. Soy supplementation did not improve any outcomes. No dietary counselling studies were identified. No studies evaluated androgen-deficiency symptoms (libido, erectile function, sleep quality, mood swings, depression, anxiety and bone mineral density). Evidence from RCTs indicates that exercise enhances health- and disease-specific QoL in men with PCa undergoing ADT. Further studies are required to evaluate the effect of exercise and dietary interventions on QoL, androgen deprivation symptoms and metabolic risk factors in this cohort. © 2016 Society for Endocrinology.

  5. Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2012-01-01

    Full Text Available Aims and Objectives: To assess the effect of Comprehensive Yogic Breathing Program on glycemic control, quality of life, and cardiac autonomic functions in diabetes. Material and Methods: This is a prospective randomized controlled intervention trial. Cardiac autonomic functions were assessed in 120 diabetics. Patients were randomized into two groups, one group receiving standard therapy for diabetes (n = 56 and the other group receiving standard therapy for diabetes and comprehensive yogic breathing program (n = 64. Standard therapy included advice on diet, walk, and oral antidiabetic drugs. Comprehensive yogic breathing program was an interactive session in which Sudarshan kriya yoga, a rhythmic cyclical breathing, preceded by Pranayam was taught under guidance of a certified teacher. Change in fasting, post prandial blood sugars, glycated hemoglobin, and quality of life were assessed. Cardiac autonomic function tests were done before and six months after intervention. Results: There was significant improvement in psychological (P = 0.006 and social domains (P = 0.04 and total quality of life (P = 0.02 in the group practicing comprehensive yogic breathing program as compared to the group following standard therapy alone. In the group following breathing program, the improvement in sympathetic cardiac autonomic functions was statistically significant (P = 0.01, while the change in the standard group was not significant (P = 0.17. When both parasympathetic and sympathetic cardiac autonomic functions were considered, there was a trend toward improvement in patients following comprehensive yogic breathing program (P = 0.07. In the standard therapy group, no change in cardiac autonomic functions was noted (P = 0.76. The parameters of glycemic control were comparable in both groups. Conclusion: There was significant improvement in quality of life and cardiac autonomic functions in the diabetes patients practicing comprehensive yogic breathing

  6. A pragmatic randomised controlled trial of hydrotherapy and land exercises on overall well being and quality of life in rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    Nightingale Peter

    2007-03-01

    Full Text Available Abstract Background Hydrotherapy is highly valued by people with rheumatoid arthritis yet few studies have compared the benefits of exercises in heated water against exercises on land. In particular, data on quality of life is rarely reported. This is especially important because patients treated with hydrotherapy often report an enhanced sense of well-being. We report a randomised controlled trial in which we compared the effects of hydrotherapy with exercises on land on overall response to treatment, physical function and quality of life in patients with rheumatoid arthritis. Methods One hundred and fifteen patients with RA were randomised to receive a weekly 30-minute se