Effects of exercise and diet in nonobese asthma patients - a randomized controlled trial

DEFF Research Database (Denmark)

Tønnesen, Louise Lindhardt; Meteran, Howraman; Hostrup, Morten

2018-01-01

BACKGROUND: Behavioral interventions focusing on exercise and healthy diet improve asthma control in obese patients with asthma, but whether these interventions can lead to improvements in nonobese patients remains unclear. OBJECTIVES: In a randomized, controlled parallel-group design, we studied...... the effects of an 8-week intervention of either exercise (high-intensity interval training), diet (high protein/low glycemic index), or a combination of the 2, on asthma control and clinical outcomes in nonobese patients with asthma. METHODS: Nonobese adult patients with asthma (n = 149) were randomized to 1...... of 4 groups: an exercise group, a diet group, an exercise + diet group, or a control group. Outcomes included Asthma Control Questionnaire (ACQ) score, asthma-related quality-of-life (Asthma-Related Quality-of-Life Questionnaire [AQLQ]) score, inflammatory cell counts in induced sputum, FEV1...

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

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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.

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

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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

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

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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

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

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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.

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.

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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

Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

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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.

Recent randomized controlled trials in otolaryngology.

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Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

2015-03-01

To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

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

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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.

Comparison of the effect of acupressure and pilates-based exercises on sleep quality of postmenopausal women: A randomized controlled trial

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Maryam Ahmadinezhad

2017-01-01

Full Text Available Background: Postmenopausal women experience a variety of symptoms, among which sleep disorder is one of the most common problems. Acupressure and Pilates exercise programs are effective nonpharmaceutical treatments which can improve sleep quality. In the present study, we aimed to compare the effects of acupressure and Pilates-based exercises on the sleep quality of postmenopausal women referred to medical clinics. Materials and Methods: In this single-blinded randomized controlled clinical trial, we recruited 108 women aged 40–60 years who were randomly assigned into one control and two intervention groups using balanced block randomization method (three groups of 36 each. The patients in the Pilates exercise group participated in an exercise training program of three 1-hour sessions per week for 6 consecutive weeks. The participants of acupressure group received acupressure intervention three times a week for 6 weeks. The sleep quality of all participants was assessed and recorded using the Pittsburgh Sleep Quality Index (PSQI once before and once after the intervention. Results: The results showed no statistically significant difference among the three groups on the total scores of sleep quality after the intervention. The intragroup comparison revealed that the changes in the mean total scores were significant in both the intervention groups (P < 0.001 but not in the control group (P = 0.76. Conclusions: Pilates-based exercises and acupressure can effectively improve women's sleep quality. Both techniques can be applied as effective alternative and complementary methods for improving sleep quality during the postmenopausal period.

Computer-aided control of high-quality cast iron

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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.

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

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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

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

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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.

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

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

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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.

Effect of weight reduction on the quality of life in obese patients with fibromyalgia syndrome: a randomized controlled trial.

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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.

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.

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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.

Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial.

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Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebaek, Camilla

2016-12-01

The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia. Nursing home residents with severe dementia often experience social withdrawal and lower quality of life, which are suggested to be enhanced by non-pharmacological interventions. A cluster-randomized controlled trial. Ten nursing home units were randomized to robot-assisted intervention or control group (treatment as usual). Data were collected between March 2013-September 2014. 27 participants participated in group activity for 30 minutes twice a week over 12 weeks, 26 participated in the control group. Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline, after end of intervention and at 3 months follow-up. The scale and regular psychotropic medication were analysed stratified by dementia severity. Analysis using mixed model, one-way anova and linear regression were performed. An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group. The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia. The intervention group used significantly less psychotropic medication compared with the control group after end of intervention. Pleasant and engaging activities facilitated by nursing staff, such as group activity with Paro, could improve quality of life in people with severe dementia. The trial is in adherence with the CONSORT statement and is registered at www.clinicaltrials.gov (study ID number: NCT02008630). © 2016 John Wiley & Sons Ltd.

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

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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.

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

Effects of tai chi chuan on anxiety and sleep quality in young adults: lessons from a randomized controlled feasibility study

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Caldwell KL

2016-11-01

Full Text Available Karen L Caldwell,1 Shawn M Bergman,2 Scott R Collier,3 N Travis Triplett,3 Rebecca Quin,4 John Bergquist,5 Carl F Pieper6 1Department of Human Development and Psychological Counseling, 2Department of Psychology, 3Department of Health and Exercise Science, 4Department of Theatre and Dance, 5Department of Psychology, Appalachian State University, Boone, 6Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA Objective: To determine feasibility and estimate the effect of a 10-week tai chi chuan (TCC intervention on anxiety and sleep quality in young adults. Participants: Seventy-five adults (18–40 years from a predominately undergraduate mid-sized university. Methods: This was an assessor blinded, randomized feasibility trial, and participants were randomized into one of three groups: 10 weeks of TCC meeting 2 times per week, 10 weeks of TCC with a DVD of the curriculum, and control group receiving a handout on anxiety management. Anxiety and sleep quality were assessed 4 times: baseline, 4 weeks, 10 weeks (immediate post-intervention, and 2 months post-intervention. Retention was defined as a participant attending the baseline assessment and at least one other assessment. Adherence to the intervention was set a priori as attendance at 80% of the TCC classes. Results: Eighty-five percent of participants were retained during the intervention and 70% completed the 2 month follow-up assessments. To increase statistical power, the two TCC groups were combined in the analyses of anxiety and sleep quality measures. No significant changes in anxiety were found in the control group, while levels of anxiety decreased significantly over time in the two TCC groups. Sleep quality scores improved across time for all three groups, but adherent TCC participants reported greater improvement than control participants. Conclusion: TCC may be an effective nonpharmaceutical means of improving anxiety and poor sleep quality

Monitoring and discussing health-related quality of life in adolescents with type 1 diabetes improve psychosocial well-being: a randomized controlled trial

NARCIS (Netherlands)

de Wit, M.; Delemarre-van d Waal, H.A.; Bokma, J.A.; Haasnoot, K.; Houdijk, M.C.; Gemke, R.J.B.J.; Snoek, F.J.

2008-01-01

OBJECTIVE - To test the effects of monitoring and discussing of health-related quality of life (HRQoL) in adolescents with type 1 diabetes in a multicenter randomized controlled trial. RESEARCH DESIGN AND METHODS - Four centers were randomly assigned to the HRQoL intervention (46 adolescents) or

A quality assessment of randomized controlled trial reports in endodontics.

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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.

[Rethinking clinical research in surgical oncology. From comic opera to quality control].

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Evrard, Serge

2016-01-01

The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation. Copyright © 2015 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Child oral health-related quality of life and early childhood caries: a non-inferiority randomized control trial.

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Arrow, P; Klobas, E

2016-06-01

The aim of this study was to compare changes in child oral health-related quality of life (COHRQoL) after treatment for early childhood caries (ECC) using two alternative treatment approaches. A randomized control trial with random allocation of parent/child dyads with ECC to test (minimum intervention) or control (standard care). Participating parents completed the Early Childhood Oral Health Impact Scale (ECOHIS) at baseline and follow-up. Changes in ECOHIS scores and extent of COHRQoL impacts between and within groups were tested using the chi-squared statistic for groups, Wilcoxon's rank-sum test, and matched-pairs signed-rank test. Two hundred and fifty-four children were randomized (test = 127; control = 127). At baseline, mean ECOHIS score 11.1, sd 8.2; mean age = 3.8 years, sd 0.90; mean dmft = 4.9, sd 4.0; and 59% male. After a mean interval of 11.4 months, 210 children were followed-up and returned a completed questionnaire (test = 111; control = 99). There was no significant difference in COHRQoL changes between test and control. For all the children combined, there were significantly fewer impacts at follow-up in the child and family domains and the total ECOHIS, Wilcoxon signed-rank test, p test and control in the extent of the improvement. © 2016 Australian Dental Association.

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

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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.

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

The reporting quality of randomized controlled trials in orthodontics.

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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 �

Effects of music and music video interventions on sleep quality: A randomized controlled trial in adults with sleep disturbances.

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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.

A randomized, controlled trial of team-based competition to increase learner participation in quality-improvement education.

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Scales, Charles D; Moin, Tannaz; Fink, Arlene; Berry, Sandra H; Afsar-Manesh, Nasim; Mangione, Carol M; Kerfoot, B Price

2016-04-01

Several barriers challenge resident engagement in learning quality improvement (QI). We investigated whether the incorporation of team-based game mechanics into an evidence-based online learning platform could increase resident participation in a QI curriculum. Randomized, controlled trial. Tertiary-care medical center residency training programs. Resident physicians (n = 422) from nine training programs (anesthesia, emergency medicine, family medicine, internal medicine, ophthalmology, orthopedics, pediatrics, psychiatry and general surgery) randomly allocated to a team competition environment (n = 200) or the control group (n = 222). Specialty-based team assignment with leaderboards to foster competition, and alias assignment to de-identify individual participants. Participation in online learning, as measured by percentage of questions attempted (primary outcome) and additional secondary measures of engagement (i.e. response time). Changes in participation measures over time between groups were assessed with a repeated measures ANOVA framework. Residents in the intervention arm demonstrated greater participation than the control group. The percentage of questions attempted at least once was greater in the competition group (79% [SD ± 32] versus control, 68% [SD ± 37], P= 0.03). Median response time was faster in the competition group (P= 0.006). Differences in participation continued to increase over the duration of the intervention, as measured by average response time and cumulative percent of questions attempted (each Ponline course delivering QI content. Medical educators should consider game mechanics to optimize participation when designing learning experiences. Published by Oxford University Press in association with the International Society for Quality in Health Care 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Comparisons for Effectiveness of Aromatherapy and Acupressure Massage on Quality of Life in Career Women: A Randomized Controlled Trial.

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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.

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

A pilot cluster randomized controlled trial of structured goal-setting following stroke.

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Taylor, William J; Brown, Melanie; William, Levack; McPherson, Kathryn M; Reed, Kirk; Dean, Sarah G; Weatherall, Mark

2012-04-01

To determine the feasibility, the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal-setting. A cluster randomized controlled trial. Inpatient rehabilitation facilities. People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal-setting and complete the primary outcome measure. Structured goal elicitation using the Canadian Occupational Performance Measure. Quality of life at 12 weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW), Functional Independence Measure, Short Form 36 and Patient Perception of Rehabilitation (measuring satisfaction with rehabilitation). Assessors were blinded to the intervention. Four rehabilitation services and 41 patients were randomized. We found high values of the intraclass correlation for the outcome measures (ranging from 0.03 to 0.40) and high variance of the SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1, leading to impractically large sample size requirements for a cluster randomized design. A cluster randomized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal-setting. Other techniques for coping with contamination effects are necessary.

Standards for reporting randomized controlled trials in neurosurgery.

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Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S

2011-02-01

The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could

Pretreatment with coenzyme Q10 improves ovarian response and embryo quality in low-prognosis young women with decreased ovarian reserve: a randomized controlled trial.

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Xu, Yangying; Nisenblat, Victoria; Lu, Cuiling; Li, Rong; Qiao, Jie; Zhen, Xiumei; Wang, Shuyu

2018-03-27

Management of women with reduced ovarian reserve or poor ovarian response (POR) to stimulation is one of the major challenges in reproductive medicine. The primary causes of POR remain elusive and oxidative stress was proposed as one of the important contributors. It has been suggested that focus on the specific subpopulations within heterogeneous group of poor responders could assist in evaluating optimal management strategies for these patients. This study investigated the effect of anti-oxidant treatment with coenzyme Q10 (CoQ10) on ovarian response and embryo quality in young low-prognosis patients with POR. This prospective, randomized controlled study included 186 consecutive patients with POR stratified according to the POSEIDON classification group 3 (age reserve parameters). The participants were randomized to the CoQ10 pre-treatment for 60 days preceding IVF-ICSI cycle or no pre-treatment. The number of high quality embryos was a primary outcome measure. A total of 169 participants were evaluated (76 treated with CoQ10 and 93 controls); 17 women were excluded due to low compliance with CoQ10 administration. The baseline demographic and clinical characteristics were comparable between the groups. CoQ10 pretreatment resulted in significantly lower gonadotrophin requirements and higher peak E2 levels. Women in CoQ10 group had increased number of retrieved oocytes (4, IQR 2-5), higher fertilization rate (67.49%) and more high-quality embryos (1, IQR 0-2); p reserve in IVF-ICSI cycles. Further work is required to determine whether there is an effect on clinical treatment endpoints.

Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

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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

Spirometry and regular follow-up do not improve quality of life in children or adolescents with asthma: Cluster randomized controlled trials.

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Abramson, Michael J; Schattner, Rosa L; Holton, Christine; Simpson, Pam; Briggs, Nancy; Beilby, Justin; Nelson, Mark R; Wood-Baker, Richard; Thien, Francis; Sulaiman, Nabil D; Colle, Eleonora Del; Wolfe, Rory; Crockett, Alan J; Massie, R John

2015-10-01

To determine whether spirometry and regular medical review improved quality of life or other outcomes in children and adolescents with asthma. We conducted two cluster randomized controlled trials. We recruited 238 asthma patients aged between 7 and 17 years from 56 general practices in South Eastern Australia. Participants were randomized to receive an intervention that included spirometry or usual care. The main outcome measure was asthma related quality of life. Baseline characteristics were well matched between the intervention and control groups. Neither trial found any difference in asthma related quality of life between groups. However because of measurement properties, a formal meta-analysis could not be performed. Nor were there any significant effects of the intervention upon asthma attacks, limitation to usual activities, nocturnal cough, bother during physical activity, worry about asthma, or written asthma action plans. The findings do not support more widespread use of spirometry for the management of childhood asthma in general practice, unless it is integrated into a complete management model. © 2014 Wiley Periodicals, Inc.

A hospital-randomized controlled trial of a formal quality improvement educational program in rural and small community Texas hospitals: one year results.

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Filardo, Giovanni; Nicewander, David; Herrin, Jeph; Edwards, Janine; Galimbertti, Percy; Tietze, Mari; McBride, Susan; Gunderson, Julie; Collinsworth, Ashley; Haydar, Ziad; Williams, Josie; Ballard, David J

2009-08-01

To investigate the effectiveness of a quality improvement educational program in rural hospitals. Hospital-randomized controlled trial. A total of 47 rural and small community hospitals in Texas that had previously received a web-based benchmarking and case-review tool. The 47 hospitals were randomized either to receive formal quality improvement educational program or to a control group. The educational program consisted of two 2-day didactic sessions on continuous quality improvement techniques, followed by the design, implementation and reporting of a local quality improvement project, with monthly coaching conference calls and annual follow-up conclaves. Performance on core measures for community-acquired pneumonia and congestive heart failure were compared between study groups to evaluate the impact of the educational program. No significant differences were observed between the study groups on any measures. Of the 23 hospitals in the intervention group, only 16 completed the didactic program and 6 the full training program. Similar results were obtained when these groups were compared with the control group. While the observed results suggest no incremental benefit of the quality improvement educational program following implementation of a web-based benchmarking and case-review tool in rural hospitals, given the small number of hospitals that completed the program, it is not conclusive that such programs are ineffective. Further research incorporating supporting infrastructure, such as physician champions, financial incentives and greater involvement of senior leadership, is needed to assess the value of quality improvement educational programs in rural hospitals.

Yoga in Correctional Settings: A Randomized Controlled Study

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Nóra Kerekes

2017-10-01

Full Text Available BackgroundThe effect of yoga in the reduction of depressive symptoms, anxiety, stress, anger as well as in the increased ability of behavioral control has been shown. These effects of yoga are highly relevant for prison inmates who often have poor mental health and low impulse control. While it has been shown that yoga and meditation can be effective in improving subjective well-being, mental health, and executive functioning within prison populations, only a limited number of studies have proved this, using randomized controlled settings.MethodsA total of 152 participants from nine Swedish correctional facilities were randomly assigned to a 10-week yoga group (one class a week; N = 77 or a control group (N = 75. Before and after the intervention period, participants answered questionnaires measuring stress, aggression, affective states, sleep quality, and psychological well-being and completed a computerized test measuring attention and impulsivity.ResultsAfter the intervention period, significant improvements were found on 13 of the 16 variables within the yoga group (e.g., less perceived stress, better sleep quality, an increased psychological and emotional well-being, less aggressive, and antisocial behavior and on two within the control group. Compared to the control group, yoga class participants reported significantly improved emotional well-being and less antisocial behavior after 10 weeks of yoga. They also showed improved performance on the computerized test that measures attention and impulse control.ConclusionIt can be concluded that the yoga practiced in Swedish correctional facilities has positive effects on inmates’ well-being and on considerable risk factors associated with recidivism, such as impulsivity and antisocial behavior. Accordingly, the results show that yoga practice can play an important part in the rehabilitation of prison inmates.

Nurse case-manager vs multifaceted intervention to improve quality of osteoporosis care after wrist fracture: randomized controlled pilot study.

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Majumdar, S R; Johnson, J A; Bellerose, D; McAlister, F A; Russell, A S; Hanley, D A; Garg, S; Lier, D A; Maksymowych, W P; Morrish, D W; Rowe, B H

2011-01-01

Few outpatients with fractures are treated for osteoporosis in the years following fracture. In a randomized pilot study, we found a nurse case-manager could double rates of osteoporosis testing and treatment compared with a proven efficacious quality improvement strategy directed at patients and physicians (57% vs 28% rates of appropriate care). Few patients with fractures are treated for osteoporosis. An intervention directed at wrist fracture patients (education) and physicians (guidelines, reminders) tripled osteoporosis treatment rates compared to controls (22% vs 7% within 6 months of fracture). More effective strategies are needed. We undertook a pilot study that compared a nurse case-manager to the multifaceted intervention using a randomized trial design. The case-manager counseled patients, arranged bone mineral density (BMD) tests, and prescribed treatments. We included controls from our first trial who remained untreated for osteoporosis 1-year post-fracture. Primary outcome was bisphosphonate treatment and secondary outcomes were BMD testing, appropriate care (BMD test-treatment if bone mass low), and costs. Forty six patients untreated 1-year after wrist fracture were randomized to case-manager (n = 21) or multifaceted intervention (n = 25). Median age was 60 years and 68% were female. Six months post-randomization, 9 (43%) case-managed patients were treated with bisphosphonates compared with 3 (12%) multifaceted intervention patients (relative risk [RR] 3.6, 95% confidence intervals [CI] 1.1-11.5, p = 0.019). Case-managed patients were more likely than multifaceted intervention patients to undergo BMD tests (81% vs 52%, RR 1.6, 95%CI 1.1-2.4, p = 0.042) and receive appropriate care (57% vs 28%, RR 2.0, 95%CI 1.0-4.2, p = 0.048). Case-management cost was $44 (CDN) per patient vs $12 for the multifaceted intervention. A nurse case-manager substantially increased rates of appropriate testing and treatment for osteoporosis in

Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial.

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Hermans, Michel P; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank; Vandenberghe, Hans; Brotons, Carlos

2013-11-01

To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. Primary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile.

Intraoperative Nerve Blocks Fail to Improve Quality of Recovery after Tissue Expander Breast Reconstruction: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Clinical Trial.

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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.

Importance of implementing an analytical quality control system in a core laboratory.

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Marques-Garcia, F; Garcia-Codesal, M F; Caro-Narros, M R; Contreras-SanFeliciano, T

2015-01-01

The aim of the clinical laboratory is to provide useful information for screening, diagnosis and monitoring of disease. The laboratory should ensure the quality of extra-analytical and analytical process, based on set criteria. To do this, it develops and implements a system of internal quality control, designed to detect errors, and compare its data with other laboratories, through external quality control. In this way it has a tool to detect the fulfillment of the objectives set, and in case of errors, allowing corrective actions to be made, and ensure the reliability of the results. This article sets out to describe the design and implementation of an internal quality control protocol, as well as its periodical assessment intervals (6 months) to determine compliance with pre-determined specifications (Stockholm Consensus(1)). A total of 40 biochemical and 15 immunochemical methods were evaluated using three different control materials. Next, a standard operation procedure was planned to develop a system of internal quality control that included calculating the error of the analytical process, setting quality specifications, and verifying compliance. The quality control data were then statistically depicted as means, standard deviations, and coefficients of variation, as well as systematic, random, and total errors. The quality specifications were then fixed and the operational rules to apply in the analytical process were calculated. Finally, our data were compared with those of other laboratories through an external quality assurance program. The development of an analytical quality control system is a highly structured process. This should be designed to detect errors that compromise the stability of the analytical process. The laboratory should review its quality indicators, systematic, random and total error at regular intervals, in order to ensure that they are meeting pre-determined specifications, and if not, apply the appropriate corrective actions

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.

Effects of music videos on sleep quality in middle-aged and older adults with chronic insomnia: a randomized controlled trial.

Science.gov (United States)

Lai, Hui-Ling; Chang, En-Ting; Li, Yin-Ming; Huang, Chiung-Yu; Lee, Li-Hua; Wang, Hsiu-Mei

2015-05-01

Listening to soothing music has been used as a complementary therapy to improve sleep quality. However, there is no empirical evidence for the effects of music videos (MVs) on sleep quality in adults with insomnia as assessed by polysomnography (PSG). In this randomized crossover controlled trial, we compared the effects of a peaceful Buddhist MV intervention to a usual-care control condition before bedtime on subjective and objective sleep quality in middle-aged and older adults with chronic insomnia. The study was conducted in a hospital's sleep laboratory. We randomly assigned 38 subjects, aged 50-75 years, to an MV/usual-care sequence or a usual-care/MV sequence. After pretest data collection, testing was held on two consecutive nights, with subjects participating in one condition each night according to their assigned sequence. Each intervention lasted 30 min. Sleep was assessed using PSG and self-report questionnaires. After controlling for baseline data, sleep-onset latency was significantly shorter by approximately 2 min in the MV condition than in the usual-care condition (p = .002). The MV intervention had no significant effects relative to the usual care on any other sleep parameters assessed by PSG or self-reported sleep quality. These results suggest that an MV intervention may be effective in promoting sleep. However, the effectiveness of a Buddhist MV on sleep needs further study to develop a culturally specific insomnia intervention. Our findings also suggest that an MV intervention can serve as another option for health care providers to improve sleep onset in people with insomnia. © The Author(s) 2014.

Deliberate Practice Enhances Quality of Laparoscopic Surgical Performance in a Randomized Controlled Trial: from Arrested Development to Expert Performance

Science.gov (United States)

Hashimoto, Daniel A.; Sirimanna, Pramudith; Gomez, Ernest D.; Beyer-Berjot, Laura; Ericsson, K. Anders; Williams, Noel N.; Darzi, Ara; Aggarwal, Rajesh

2014-01-01

Background This study investigated whether deliberate practice leads to an increase in surgical quality in virtual reality (VR) laparoscopic cholecystectomies (LC). Previous research has suggested that sustained DP is effective in surgical training. Methods Fourteen residents were randomized into deliberate practice (n=7) or control training (n=7). Both groups performed 10 sessions of two VR LCs. Each session, the DP group was assigned 30 minutes of DP activities in between LCs while the control group viewed educational videos or read journal articles. Performance was assessed on speed and dexterity; quality was rated with global (GRS) and procedure-specific (PSRS) rating scales. All participants then performed five porcine LCs. Results Both groups improved over 20 VR LCs in time, dexterity, and global rating scales (all pachieved higher quality of VR surgical performance than control for GRS (26 vs. 20, p=0.001) and PSRS (18 vs. 15, p=0.001). For VR cases, DP subjects plateaued at GRS=25 after 10 cases and control group at GRS=20 after five cases. At completion of VR training, 100% of the DP group reached target quality of performance (GRS≥21) compared to 30% in the control group. There were no significant differences for improvements in time or dexterity over five porcine LCs. Conclusion This study suggests that DP leads to higher quality performance in VR LC than standard training alone. Standard training may leave individuals in a state of “arrested development” compared to DP. PMID:25539697

Effects of supportive-expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors: a randomized control trial.

Science.gov (United States)

Tabrizi, Fatemeh Moghaddam; Radfar, Moloud; Taei, Zeynab

2016-09-01

Evaluation of the effect of supportive expressive discussion groups on loneliness, hope and quality of life in breast cancer survivors. A randomized control trial including breast cancer patients who had completed chemotherapy and randomly allocated into two groups: intervention (n = 41) and control (n = 40). The intervention consisted of twelve weekly 90-min sessions for groups of six to eight breast cancer survivors. Data were obtained pre-to -post the intervention and at 8-week follow-up. The data were analyzed using a repeated-measures analysis of variance (ANOVA). The findings revealed a significant reduction in loneliness scores (F = 69.85, p hope (F = 20.8, p life from pre- to post-intervention, and then over the 8-week follow-up period in the intervention group, while scores of control participants did not show this pattern during the study. The strongest effects were found for global quality of life (effect size) = 0.59), for future perspectives (effect size = 0.51), emotional functioning (effect size = 0.35) and social functioning (effect size = 0.31). The intervention was effective on loneliness, hope and quality of life in the intervention group. The intervention needs further evaluation in a larger study and with other cancer types. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Quality control of coated fuel particles for high temperature gas-cooled reactor

International Nuclear Information System (INIS)

Kaneko, Mitsunobu

1987-01-01

The quality control of the coated fuel particles for high temperature gas-cooled reactors is characterized by the fact that the size of the target product to be controlled is very small, and the quantity is very large. Accordingly, the sampling plan and the method of evaluating the population through satisfically treating the measured data of the samples are the important subjects to see and evaluate the quality of a batch or a lot. This paper shows the fabrication process and the quality control procedure for the coated fuel particles. The development work of a HTGR was started by Japan Atomic Energy Research Institute in 1969, and as for the production technology for coated fuel particles, Nuclear Fuel Industries, Ltd. has continued the development work. The pilot plan with the capacity of about 40 kg/year was established in 1972. The fuel product fabricated in this plant was put to the irradiation experiment and out-of-pile evaluation test. In 1983, the production capacity was expanded to 200 kg/year, and the fuel compacts for the VHTRC in JAERI were produced for two years. The basic fuel design, the fabrication process, the quality control, the process control and the quality assurance are reported. For the commercial product, the studies from the viewpoint of production and quality control costs are required. (Kako, I.)

Effect of mindfulness and yoga on quality of life for elementary school students and teachers: results of a randomized controlled school-based study.

Science.gov (United States)

Bazzano, Alessandra N; Anderson, Christopher E; Hylton, Chelsea; Gustat, Jeanette

2018-01-01

To assess the impact of a yoga curriculum in an elementary school on student quality of life, and to assess teacher and staff perception of potential barriers to, and benefits of, introducing yoga and mindfulness into the classroom. A randomized controlled trial was utilized to assess the impact of a brief intervention on third-grade students who screened positive for symptoms of anxiety. Students were randomized to an intervention group of 20 students receiving small-group yoga/mindfulness activities for 8 weeks between October 2016 and February 2017, and a control group of 32 students receiving care as usual. The Brief Multidimensional Students' Life Satisfaction Scale-Peabody Treatment Progress Battery and the Pediatric Quality of Life Inventory (PedsQL) served as outcomes. Teachers were invited to participate in two professional development sessions about introducing yoga and mindfulness into the classroom, and completed a survey following each of the sessions. In generalized estimating equation models adjusted for time, the yoga-based intervention was associated with a 14.17 unit increase in student emotional PedsQL ( p -value 0.001) and a 7.43 unit increase in psychosocial PedsQL ( p -value 0.01). Results were not attenuated by adjustment. Teachers and staff reported using yoga more frequently in the classroom following the second of two professional development sessions ( p -value classroom were similar at two data collection time points, while perceived benefits remained high. The intervention was associated with a significant improvement in emotional and psychosocial quality of life in the intervention group when compared to the control group, suggesting that yoga/mindfulness interventions may improve symptoms of anxiety among students. Yoga/mindfulness activities may facilitate stress management among elementary school students and may be added as a complement to social and emotional learning activities.

Asthma Self-Management Model: Randomized Controlled Trial

Science.gov (United States)

Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

2016-01-01

Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

Efficacy of a Social Self-Value Empowerment Intervention to Improve Quality of Life of HIV Infected People Receiving Antiretroviral Treatment in Nepal: A Randomized Controlled Trial.

Science.gov (United States)

Bhatta, Dharma Nand; Liabsuetrakul, Tippawan

2017-06-01

We developed a comprehensive and culturally applicable empowerment intervention social self-value package with an aim to assess its efficacy in order to improve the quality of life (QoL) of HIV infected people receiving antiretroviral treatment. Participants were randomly allocated to receive either six weekly intervention sessions or standard care. Nonlinear mixed-effects models were performed to compare changes in empowerment scores over time. Between September and November 2014, 1447 individuals were screened, of whom 132 were randomly assigned to either the intervention or control group. The mean scores of empowerment, social support and quality of life increased and stigma scores were reduced in the intervention group at 3- and 6-months. An intervention effect on social support, stigma and QoL was significantly increased by time and group with low and high empowerment. No adverse events were reported. The empowerment intervention was efficacious in improving QoL of HIV infected people.

Effect of whole body cryotherapy interventions on health-related quality of life in fibromyalgia patients: A randomized controlled trial.

Science.gov (United States)

Vitenet, M; Tubez, F; Marreiro, A; Polidori, G; Taiar, R; Legrand, F; Boyer, F C

2018-02-01

Although fibromyalgia syndrome (SFM) affects 2-4 percent of adults, research has not identified a preferred therapeutic option for patients worldwide yet. Based on recent findings, it can be expected that whole body cryotherapy can improve health-reported quality of life by alleviating the symptoms of musculoskeletal pain and fatigue. Our aim was to determine whether whole body cryotherapy only can result in improved perceived health and quality of life in fibromyalgia patients. 24 patients with fibromyalgia diagnosis were randomized into 2 groups (n=11 in the whole body cryotherapy group, n=13 in the control group). In the whole body cryotherapy group, 10 sessions of whole body cryotherapy were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8days. Subjects in the control group did not change anything in their everyday activities. Quality of life was assessed just before and one month after treatment. Compared with the control group, patients in the whole body cryotherapy group reported significantly improved for health-reported quality of life. These effects lasted for at least one month following intervention. Based on these findings, whole body cryotherapy can be recommended as an effective clinically adjuvant approach in the improvement of health-related quality of life in fibromyalgia patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

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.

A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury.

Science.gov (United States)

Theadom, Alice; Barker-Collo, Suzanne; Jones, Kelly; Dudley, Margaret; Vincent, Norah; Feigin, Valery

2018-05-01

To explore feasibility and potential efficacy of on-line interventions for sleep quality following a traumatic brain injury (TBI). A two parallel-group, randomized controlled pilot study. Community-based. In all, 24 participants (mean age: 35.9 ± 11.8 years) who reported experiencing sleep difficulties between 3 and 36 months after a mild or moderate TBI. Participants were randomized to receive either a cognitive behaviour therapy or an education intervention on-line. Both interventions were self-completed for 20-30 minutes per week over a six-week period. The Pittsburgh Sleep Quality Index assessed self-reported sleep quality with actigraphy used as an objective measure of sleep quality. The CNS Vital Signs on-line neuropsychological test assessed cognitive functioning and the Rivermead Post-concussion Symptoms and Quality of Life after Brain Injury questionnaires were completed pre and post intervention. Both programmes demonstrated feasibility for use post TBI, with 83.3% of participants completing the interventions. The cognitive behaviour therapy group experienced significant reductions ( F = 5.47, p = 0.04) in sleep disturbance (mean individual change = -4.00) in comparison to controls post intervention (mean individual change = -1.50) with a moderate effect size of 1.17. There were no significant group differences on objective sleep quality, cognitive functioning, post-concussion symptoms or quality of life. On-line programmes designed to improve sleep are feasible for use for adults following mild-to-moderate TBI. Based on the effect size identified in this pilot study, 128 people (64 per group) would be needed to determine clinical effectiveness.

Effects of combined high-intensity aerobic interval training program and Mediterranean diet recommendations after myocardial infarction (INTERFARCT Project): study protocol for a randomized controlled trial.

Science.gov (United States)

Maldonado-Martín, Sara; Jayo-Montoya, Jon Ander; Matajira-Chia, Tatiana; Villar-Zabala, Beatriz; Goiriena, Juan José; Aispuru, G Rodrigo

2018-03-02

Exercise therapy has long been used for rehabilitation purposes after myocardial infarction (MI) and the benefit of regular physical exercise is also well-established. High-intensity interval training (HIIT) has been proposed to be more effective than continuous exercise for improving exercise capacity and health-related adaptations to low-volume (LV) and HIIT are also known. Furthermore, the Mediterranean diet (Mediet) has been widely reported to be a model of healthy eating for its contribution to a favorable health status and a better quality of life, reducing overall mortality. This study will investigate the effects of different HIIT programs (high-volume [HV] vs LV) and Mediet recommendations in clinical condition, cardiorespiratory fitness, biomarkers, ventricular function, and perception of quality of life after MI, and compared to an attention control group that is recommended to Mediet and physical activity without supervision sessions. In this randomized controlled trial, cardiorespiratory fitness, anthropometry, central and peripheral cardiovascular variables, biochemical and nutritional condition, and quality of life will be assessed before and after 16 weeks of intervention in 177 participants diagnosed with MI type 1. All participants will be randomly (1:1:1) assigned to the attention control group or two exercise groups (Mediet recommendations plus supervised aerobic exercise two days/week: (1) HV (40 min) HIIT group and (2) LV (20 min) HIIT group. This study will be the first clinical trial comparing the effects of two different volumes of HIIT programs with Mediet recommendations for people after MI. The results of this study will provide good evidence for physical rehabilitation in this population. ClinicalTrials.gov, NCT02876952 . Registered on 24 August 2016.

[Effects of aerobic exercise program and relaxation techniques on anxiety, quality of sleep, depression, and quality of life in patients with fibromyalgia: a randomized controlled trial].

Science.gov (United States)

Arcos-Carmona, Isabel María; Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo Adolfo; Gutiérrez-Rubio, Ana Belén; Ramos-González, Elena; Moreno-Lorenzo, Carmen

2011-10-08

Fibromyalgia is considered as a combination of physical, psychological and social disabilities. The purpose of the present study was to determine the benefits of aerobic exercise program and progressive relaxation techniques on anxiety, quality of sleep, depression and quality of life in patients with fibromyalgia. An experimental study was performed with a placebo control group. Fifty-six fibromyalgia patients were randomly assigned to intervention (aerobic exercises+progressive relaxation techniques) and placebo (sham treatment with disconnected magnet therapy device) groups. Outcome measures were anxiety (STAI- State Trait Anxiety Inventory), quality of sleep (Pittsburgh sleep quality index), depression (Beck depression inventory) and quality of life (questionnaire SF-36). Measures were performed at baseline and after 10-weeks treatment. After 10 weeks of treatment, the intervention group showed significant reduction (pquality of life. The combination of aerobic exercise program and progressive relaxation techniques contribute to improve night rest, trait anxiety and quality of life in patients with fibromyalgia. Copyright © 2010 Elsevier España, S.L. All rights reserved.

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.

Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

OpenAIRE

Arija Victoria; Martín Núria; Canela Teresa; Anguera Carme; Castelao Ana I; García-Barco Montserrat; García-Campo Antoni; González-Bravo Ana I; Lucena Carme; Martínez Teresa; Fernández-Barrés Silvia; Pedret Roser; Badia Waleska; Basora Josep

2012-01-01

Abstract Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of t...

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

Effect of tree nuts on glycemic control in diabetes: a systematic review and meta-analysis of randomized controlled dietary trials.

Directory of Open Access Journals (Sweden)

Effie Viguiliouk

Full Text Available Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent.To provide better evidence for diabetes guidelines development, we conducted a systematic review and meta-analysis of randomized controlled trials to assess the effects of tree nuts on markers of glycemic control in individuals with diabetes.MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 2014.Randomized controlled trials ≥3 weeks conducted in individuals with diabetes that compare the effect of diets emphasizing tree nuts to isocaloric diets without tree nuts on HbA1c, fasting glucose, fasting insulin, and HOMA-IR.Two independent reviewer's extracted relevant data and assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD with 95% CI's. Heterogeneity was assessed (Cochran Q-statistic and quantified (I2.Twelve trials (n = 450 were included. Diets emphasizing tree nuts at a median dose of 56 g/d significantly lowered HbA1c (MD = -0.07% [95% CI:-0.10, -0.03%]; P = 0.0003 and fasting glucose (MD = -0.15 mmol/L [95% CI: -0.27, -0.02 mmol/L]; P = 0.03 compared with control diets. No significant treatment effects were observed for fasting insulin and HOMA-IR, however the direction of effect favoured tree nuts.Majority of trials were of short duration and poor quality.Pooled analyses show that tree nuts improve glycemic control in individuals with type 2 diabetes, supporting their inclusion in a healthy diet. Owing to the uncertainties in our analyses there is a need for longer, higher quality trials with a focus on using nuts to displace high-glycemic index carbohydrates.ClinicalTrials.gov NCT01630980.

Tai chi qigong as a means to improve night-time sleep quality among older adults with cognitive impairment: a pilot randomized controlled trial

Directory of Open Access Journals (Sweden)

Chan AWK

2016-09-01

Full Text Available Aileen WK Chan, Doris SF Yu, KC Choi, Diana TF Lee, Janet WH Sit, Helen YL Chan The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, People’s Republic of China Purpose: Age-related cognitive decline is a growing public health concern worldwide. More than a quarter of adults with cognitive impairment experience sleep disturbance. The objective of this pilot study was to evaluate the preliminary effects of tai chi qigong (TCQ on improving the night-time sleep quality of older adults with cognitive impairment. Participants: Older adults with cognitive impairment who complain of sleep disturbance. Methods: A randomized controlled trial with two groups. Fifty-two subjects were recruited from two district elderly community centers and randomly assigned to either the TCQ group (n=27 or the control group (n=25. The intervention group received TCQ training consisting of two 60-minute sessions each week for 2 months. The control group was advised to maintain their usual activities. Sleep quality was measured by the Chinese Pittsburgh Sleep Quality Index. Quality of life was measured by Short-form 12, cognitive functions measured by mini-mental state examination, and subjective memory deficits measured by the memory inventory for Chinese. Results: Data were collected at baseline, 2 months, and 6 months. Significant results were noted at 6 months in the Chinese Pittsburgh Sleep Quality Index global score (P=0.004, sleep duration (P=0.003, habitual sleep efficiency (P=0.002, and the Short-form 12 mental health component (P<0.001. The TCQ participants reported better sleep quality and a better (quality of life mental health component than the control group. Conclusion: TCQ can be considered a useful nonpharmacological approach for improving sleep quality in older adults with cognitive impairment.Clinical trial registration: CUHK_CCT00448 (https://www2.ccrb.cuhk.edu.hk/registry/public/287. Keywords: cognitive decline, mind�

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.

Experience of quality control for material accountancy analysis in Pu fuel facility

International Nuclear Information System (INIS)

Sumi, Mika; Satoh, Mitsuhiro; Ohnishi, Sumitaka; Suzuki, Toru

2003-01-01

Destructive analysis for material accountancy purpose should maintain higher precision referring the International Target Value (ITV). Quality control for the analysis is effective tool to maintain the analytical precision in routine analysis as well as to improve its performance. Since isotope dilution mass spectrometry for the determination of Plutonium and Uranium content and its isotopic composition has launched in the laboratory of Plutonium Fuel Center (PFC) of JNC, comprehensive quality control system has gradually growing up, which currently consists of bias detecting, random error monitoring and human error preventing system. Preventing analysis bias is the most important to maintain long-term performance of measurement. To make bias detecting capability robust, PFC is participating to several intercomparison programs regarding DA samples. Random error monitoring system is another important system to maintain high performance of each routine analysis operation, which composes functions to detect abnormal dispersion of each result and to confirm the state of health of operation of mass spectrometers by measurement of standard materials. To avoid human error during operation process, introduction of computer control system as much extent as possible is practical approach. In this paper, the comprehensive quality control system is introduced and the experiences gained so far are summarized for discussion. (author)

High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial

DEFF Research Database (Denmark)

Andersen, L.O.; Husted, H.; Otte, K.S.

2008-01-01

with a detailed description of the infiltration technique. METHODS: In a randomized, double-blind, placebo-controlled trial in 12 patients undergoing bilateral knee arthroplasty, saline or high-volume (170 ml) ropivacaine (0.2%) with epinephrine was infiltrated around each knee, with repeated doses administered...

Low-Fat Dietary Pattern Intervention and Health-Related Quality of Life: The Women's Health Initiative Randomized Controlled Dietary Modification Trial.

Science.gov (United States)

Assaf, Annlouise R; Beresford, Shirley A A; Risica, Patricia Markham; Aragaki, Aaron; Brunner, Robert L; Bowen, Deborah J; Naughton, Michelle; Rosal, Milagros C; Snetselaar, Linda; Wenger, Nanette

2016-02-01

Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women's Health Initiative Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention. To evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depression symptoms, cognitive functioning, and sleep quality. This randomized controlled trial was analyzed as intent to treat. Between 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline ≥32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type 1 diabetes, or medical conditions with predicted survival <3 years. Goals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings, and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter. The RAND 36-Item Health Survey was used to assess HRQoL at baseline, Year 1, and close-out (about 8 years postrandomization), and estimate differential HRQoL subscale change scores. Mean change in HRQoL scores (Year 1 minus baseline) were compared by randomization group using linear models. At 1 year, there was a differential change between intervention and comparison group of 1.7 units (95% CI 1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (95% CI 1.7, 2.3), vitality by 1.9 units (95% CI 1.6, 2.2), and global quality of life by 0.09 units (95% CI 0.07, 0.12). With the exception of global quality of life, these effects were significantly modified by body mass index at baseline. DM intervention was associated with small, but significant improvements in three HRQoL subscales: general health

[Acupuncture therapy for the improvement of sleep quality of outpatients receiving methadone maintenance treatment: a randomized controlled trial].

Science.gov (United States)

Li, Yi; Liu, Xue-bing; Zhang, Yao

2012-08-01

To study the efficacy and safety of acupuncture therapy for the improvement of sleep quality of outpatients receiving methadone maintenance treatment (MMT). Using randomized double-blinded controlled design, seventy-five MMT outpatients with low sleep quality [score of Pittsburgh sleep quality index (PSQI) > or = 8], were randomly assigned to the acupuncture group (38 cases) and the sham-acupuncture group (37 cases). All patients maintained previous MMT. Acupuncture was applied to Baihui (GV20), Shenmen (bilateral, TF4), Shenting (GV24), Sanyinjiao (bilateral, SP6), and Sishencong (EX-HN1) in the acupuncture group. The same procedures were performed in the sham-acupuncture group, but not to the acupoints (5 mm lateral to the acupoints selected in the acupuncture group) with shallow needling technique. The treatment was performed 5 times each week for 8 successive weeks. The PSQI was assessed before treatment, at the end of the 2nd, 4th, 6th, and 8th week of the treatment. The detection ratio of low sleep quality and the incidence of adverse acupuncture reactions were compared between the two groups at the end of the 8th week. The overall PSQI score was obviously higher in the acupuncture group than in the sham-acupuncture group with statistical difference (P acupuncture group (60.53%, 23/38 cases) than in the sham-acupuncture group (83.78%, 31/37 cases) with statistical difference (P acupuncture reaction was 5.26% (2/38 cases) in the acupuncture group and 2.70% (1/37 cases) in the sham-acupuncture group respectively, showing no statistical difference (P > 0.05). Acupuncture therapy could effectively and safely improve the sleep quality of outpatients receiving MMT.

Effect of psycho-educational interventions on quality of life in patients with implantable cardioverter defibrillators: a meta-analysis of randomized controlled trials.

Science.gov (United States)

Kao, Chi-Wen; Chen, Miao-Yi; Chen, Ting-Yu; Lin, Pai-Hui

2016-09-30

Implantable cardioverter defibrillators (ICD) were developed for primary and secondary prevention of sudden cardiac death. However, ICD recipients' mortality is significantly predicted by their quality of life (QOL). The aim of this meta-analysis was to evaluate the effects of psycho-educational interventions on QOL in patients with ICDs. We systematically searched PubMed, Medline, Cochrane Library, and CINAHL through April 2015 and references of relevant articles. Studies were reviewed if they met following criteria: (1) randomized controlled trial, (2) participants were adults with an ICD, and (3) data were sufficient to evaluate the effect of psychological or educational interventions on QOL measured by the SF-36 or SF-12. Studies were independently selected and their data were extracted by two reviewers. Study quality was evaluated using a modified Jadad scale. The meta-analysis was conducted using the Cochrane Collaboration's Review Manager Software Package (RevMan 5). Study heterogeneity was assessed by Q statistics and I 2 statistic. Depending on heterogeneity, data were pooled across trials using fixed-effect or random-effect modeling. Seven randomized controlled trials fulfilled the inclusion and exclusion criteria, and included 1017 participants. The psycho-educational interventions improved physical component summary (PCS) scores in the intervention groups more than in control groups (mean difference 2.08, 95 % CI 0.86 to 3.29, p educational interventions improved the physical component, but not the mental component of QOL in patients with ICDs.

Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.

Science.gov (United States)

Cao, Yan; Yin, Xuan; Soto-Aguilar, Francisca; Liu, Yiping; Yin, Ping; Wu, Junyi; Zhu, Bochang; Li, Wentao; Lao, Lixing; Xu, Shifen

2016-11-16

The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke. This proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up. This proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke. Chinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382 . Registered on 28 April 2016.

High-Performance Pseudo-Random Number Generation on Graphics Processing Units

OpenAIRE

Nandapalan, Nimalan; Brent, Richard P.; Murray, Lawrence M.; Rendell, Alistair

2011-01-01

This work considers the deployment of pseudo-random number generators (PRNGs) on graphics processing units (GPUs), developing an approach based on the xorgens generator to rapidly produce pseudo-random numbers of high statistical quality. The chosen algorithm has configurable state size and period, making it ideal for tuning to the GPU architecture. We present a comparison of both speed and statistical quality with other common parallel, GPU-based PRNGs, demonstrating favourable performance o...

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

Broadband plasmonic silver nanoflowers for high-performance random lasing covering visible region

Directory of Open Access Journals (Sweden)

Chang Qing

2017-05-01

Full Text Available Multicolor random lasing has broad potential applications in the fields of imaging, sensing, and optoelectronics. Here, silver nanoflowers (Ag NF with abundant nanogaps are fabricated by a rapid one-step solution-phase synthesis method and are first proposed as effective broadband plasmonic scatterers to achieve different color random lasing. With abundant nanogaps and spiky tips near the surface and the interparticle coupling effect, Ag NFs greatly enhance the local electromagnetic field and induce broadband plasmonic scattering spectra over the whole visible range. The extremely low working threshold and the high-quality factor for Ag NF-based random lasers are thus demonstrated as 0.24 MW cm−2 and 11,851, respectively. Further, coherent colorful random lasing covering the visible range is realized using the dye molecules oxazine (red, Coumarin 440 (blue, and Coumarin 153 (green, showing high-quality factor of more than 10,000. All these features show that Ag NF are highly efficient scatterers for high-performance coherent random lasing and colorful random lasers.

Family nurture intervention improves the quality of maternal caregiving in the neonatal intensive care unit: evidence from a randomized controlled trial.

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Hane, Amie A; Myers, Michael M; Hofer, Myron A; Ludwig, Robert J; Halperin, Meeka S; Austin, Judy; Glickstein, Sara B; Welch, Martha G

2015-04-01

This study assessed the impact of Family Nurture Intervention (FNI) on the quality of maternal caregiving behavior (MCB) while in the neonatal intensive care unit (NICU). FNI is a randomized controlled trial conducted in a high-acuity NICU to facilitate an emotional connection between mothers and their premature infants. FNI begins shortly after birth, continues until discharge, and involves mother/infant calming sessions that include scent cloth exchange, vocal soothing and emotion expression, eye contact, skin-to-skin and clothed holding, and family-based support sessions. Maternal caregiving behavior was coded during a single holding and feeding session (∼30 min) in the NICU before discharge at approximately 36 weeks gestational age (GA). Sixty-five mothers and their premature infants (34 male, 31 female; 26-34 wk GA) were included in these analyses (FNI, n = 35; standard care [SC], n = 30). Relative to mothers in the SC condition, those in the FNI group showed significantly higher quality MCB, which remained significant when controlling for birth order, twin status, maternal depression, and maternal anxiety. This is the first study to demonstrate that in-unit MCB can be enhanced by a hospital-based intervention. FNI provides a new rationale for integrating nurture-based interventions into standard NICU care.

HIGH QUALITY FACADE SEGMENTATION BASED ON STRUCTURED RANDOM FOREST, REGION PROPOSAL NETWORK AND RECTANGULAR FITTING

Directory of Open Access Journals (Sweden)

K. Rahmani

2018-05-01

Full Text Available In this paper we present a pipeline for high quality semantic segmentation of building facades using Structured Random Forest (SRF, Region Proposal Network (RPN based on a Convolutional Neural Network (CNN as well as rectangular fitting optimization. Our main contribution is that we employ features created by the RPN as channels in the SRF.We empirically show that this is very effective especially for doors and windows. Our pipeline is evaluated on two datasets where we outperform current state-of-the-art methods. Additionally, we quantify the contribution of the RPN and the rectangular fitting optimization on the accuracy of the result.

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

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.

Massage therapy for patients with metastatic cancer: a pilot randomized controlled trial.

Science.gov (United States)

Toth, Maria; Marcantonio, Edward R; Davis, Roger B; Walton, Tracy; Kahn, Janet R; Phillips, Russell S

2013-07-01

The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. This was a randomized controlled trial. Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects were patients with metastatic cancer. There were three interventions: massage therapy, no-touch intervention, and usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings.

Software product quality control

CERN Document Server

Wagner, Stefan

2013-01-01

Quality is not a fixed or universal property of software; it depends on the context and goals of its stakeholders. Hence, when you want to develop a high-quality software system, the first step must be a clear and precise specification of quality. Yet even if you get it right and complete, you can be sure that it will become invalid over time. So the only solution is continuous quality control: the steady and explicit evaluation of a product's properties with respect to its updated quality goals.This book guides you in setting up and running continuous quality control in your environment. Star

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.

Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

Science.gov (United States)

Eisenkopf, Gerald; Sulser, Pascal A.

2016-01-01

The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

Effect of Tai Ji Quan training on self-reported sleep quality in elderly Chinese women with knee osteoarthritis: a randomized controlled trail.

Science.gov (United States)

Lü, Jiaojiao; Huang, Lingyan; Wu, Xie; Fu, Weijie; Liu, Yu

2017-05-01

The purpose of this study was to explore the effects of a 24-week Tai Ji Quan training program on sleep quality, quality of life, and physical performance among elderly Chinese women with knee osteoarthritis (OA). A 24-week randomized, controlled trial of 46 elderly women with knee OA. Participants were randomly assigned to either a Tai Ji Quan group (n = 23) or a control group (n = 23). Participants in the Tai Ji Quan group completed training sessions three times per week, while those in the control group had bi-weekly educational classes. The primary outcome was total score of the Pittsburgh Sleep Quality of Index (PSQI). Secondary outcomes were: seven subscales of the PSQI; sleep latency; total sleep time; sleep efficiency; physical component summary (PCS) and mental component summary (MCS) of the 36-item Short Form Health Survey (SF-36); Berg Balance Scale (BBS); and Timed Up and Go (TUG). Compared with the control group, participants in the Tai Ji Quan group had significantly improved primary outcome (global PSQI score, p = 0.006) and secondary outcomes, including three PSQI sub-scores (sleep latency, p = 0.031; sleep duration, p = 0.043; daytime dysfunction, p = 0.007), total sleep time (p = 0.033), and SF-36 PCS (p = 0.006). The Tai Ji Quan group also had significant improvements compared with baseline in three PSQI sub-scores (sleep latency, p = 0.031; habitual sleep efficiency, p = 0.049; sleep disturbance, p = 0.016), sleep latency (p = 0.003), BBS (p = 0.001), and TUG (p = 0.006). Tai Ji Quan training is an effective treatment approach to improve sleep quality and quality of life in elderly Chinese women with knee OA. Chinese Clinical Trial Registry (June 16, 2013): ChiCTR-TRC-13003264. Copyright © 2017 Elsevier B.V. All rights reserved.

Concept and realization of quality control in FRG

International Nuclear Information System (INIS)

Odoj, R.; Martens, B.R.; Warnecke, E.

1987-01-01

Radioactive waste packages to be disposed of in FRG must meet the waste acceptance requirement of the repository. Compliance with the waste acceptance requirements must be checked by a quality control. Fourteen relevant properties are necessary to be assayed. The quality control group supports the observance of the waste acceptance requirements by the following measures: -checking of the documentation of the waste producers; -random tests at conditioned radioactive wastes; -qualification of conditioning processes; -control of the qualified processes by inspections. The relevant properties of disposal are termed and their checking by non-destructive and if necessary destructive test methods will be explained as well as quality control by process control, i.e. qualification of conditioning processes by instrumentation and documentation. The mobile and stationary testing facilities will be outlined

Effects of exercise programs on depressive symptoms, quality of life, and self-esteem in older people: a systematic review of randomized controlled trials.

Science.gov (United States)

Park, Seong-Hi; Han, Kuem Sun; Kang, Chang-Bum

2014-11-01

This study attempted to show evidence of exercise programs as intervention to decrease depressive symptoms and to improve quality of life and self-esteem in older people. Systematic review of randomized controlled trials. Electronic databases of KoreaMed, Korea Scientific and Technological Intelligence Center, Korean Society of Nursing Science, Korean Academy of Psychiatric Mental Health Nursing, Ovid-Medline and Embase were searched up to May 25th, 2012 for relevant articles. We searched studies of randomized controlled trials involving exercise programs administered to participants aged 65 years or over. Of 461 publications identified, 18 met the inclusion criteria for the meta-analysis. Quality assessment of the studies utilized Cochrane's Risk of Bias. Exercise therapy in older people was effective, as evidenced by a decrease in depressive symptoms [standardized mean difference (SMD) -0.36; 95% confidence interval (CI) -0.64, -0.08], and improvements in quality of life (SMD 0.86; 95% CI 0.11, 1.62) and self-esteem (SMD 0.49; 95% CI 0.09, 0.88). The changes were significant statistically, with no heterogeneity. Exercise programs in older people are effective in improving depressive symptoms, quality of life and self-esteem. Development and efficient use of tailored exercise programs for elderly people is a prudent strategy. Copyright © 2014 Elsevier Inc. All rights reserved.

The effect of psycho-educational interventions on the quality of life of the family caregivers of the patients with spinal cord injury: a randomized controlled trial.

Science.gov (United States)

Molazem, Zahra; Falahati, Tayebeh; Jahanbin, Iran; Jafari, Peyman; Ghadakpour, Soraya

2014-01-01

Family caregivers usually report the reduction of their life quality due to one of the family member's spinal cord injury. Thus, the present study aimed to investigate the effectiveness of psycho-educational interventions on the life quality of the family caregivers of the patients with spinal cord injury. The present randomized controlled trial was conducted on 72 family caregivers who had the primary responsibility of taking care of the patients with spinal cord injury. The participants were randomly divided into intervention (n=36) and control groups (n=36). The intervention group was involved in 90-minute educational sessions held once a week for four weeks. Both groups completed SF-36 questionnaire before and 2 and 6 weeks after the intervention. Then, the data were analyzed through independent t-test, Chi-square, and repeated measures ANOVA. All the caregivers had low quality of life and the lowest mean score was related to mental health in both groups. After the intervention, various dimensions of life quality had improved in the intervention group's caregivers compared to the control group (Peducational interventions on the life quality of the caregivers of the patients with spinal cord injury. According to the results, the authorities have to pay special attention to the problems of this group and educational interventions have to be continuously followed. IRCT2013070811388N2.

The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

William F. Clark

2017-08-01

Full Text Available Background: In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. Objective: To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR in patients with chronic kidney disease. Design: Parallel-group randomized controlled trial. Setting: Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. Participants: Adults (n = 631 with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m 2 and microalbuminuria. Intervention: The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight, over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. Measures: Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. Primary outcome: The between-group change in eGFR from baseline (prerandomization to 12 months after randomization. Secondary outcomes: Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation, and health-related quality of life. Planned analysis: The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using

Effect of flashlight guidance on manual ventilation performance in cardiopulmonary resuscitation: A randomized controlled simulation study.

Science.gov (United States)

Kim, Ji Hoon; Beom, Jin Ho; You, Je Sung; Cho, Junho; Min, In Kyung; Chung, Hyun Soo

2018-01-01

Several auditory-based feedback devices have been developed to improve the quality of ventilation performance during cardiopulmonary resuscitation (CPR), but their effectiveness has not been proven in actual CPR situations. In the present study, we investigated the effectiveness of visual flashlight guidance in maintaining high-quality ventilation performance. We conducted a simulation-based, randomized, parallel trial including 121 senior medical students. All participants were randomized to perform ventilation during 2 minutes of CPR with or without flashlight guidance. For each participant, we measured mean ventilation rate as a primary outcome and ventilation volume, inspiration velocity, and ventilation interval as secondary outcomes using a computerized device system. Mean ventilation rate did not significantly differ between flashlight guidance and control groups (P = 0.159), but participants in the flashlight guidance group exhibited significantly less variation in ventilation rate than participants in the control group (Pguidance group. Our results demonstrate that flashlight guidance is effective in maintaining a constant ventilation rate and interval. If confirmed by further studies in clinical practice, flashlight guidance could be expected to improve the quality of ventilation performed during CPR.

High perfomance liquid chromatography fingerprint analysis for quality control of brotowali (Tinospora crispa)

Science.gov (United States)

Syarifah, V. B.; Rafi, M.; Wahyuni, W. T.

2017-05-01

Brotowali (Tinospora crispa) is widely used in Indonesia as ingredient of herbal medicine formulation. To ensure the quality, safety, and efficacy of herbal medicine products, its chemical constituents should be continuously evaluated. High performance liquid chromatography (HPLC) fingerprint is one of powerful technique for this quality control process. In this study, HPLC fingerprint analysis method was developed for quality control of brotowali. HPLC analysis was performed in C18 column and detection was performed using photodiode array detector. The optimum mobile phase for brotowali fingerprint was acetonitrile (ACN) and 0.1% formic acid in gradient elution mode at a flow rate of 1 mL/min. The number of peaks detected in HPLC fingerprint of brotowali was 32 peaks and 23 peaks for stems and leaves, respectively. Berberine as marker compound was detected at retention time of 20.525 minutes. Evaluation of analytical performance including precision, reproducibility, and stability prove that this HPLC fingerprint analysis was reliable and could be applied for quality control of brotowali.

Randomized Controlled Trial of Expressive Writing and Quality of Life in Men and Women Treated for Colorectal Cancer

Science.gov (United States)

Lepore, Stephen J.; Revenson, Tracey A.; Roberts, Katherine J.; Pranikoff, Julie R.; Davey, Adam

2014-01-01

Objective This randomized trial tested (1) whether a home-based expressive writing (EW) intervention improves quality of life in patients with colorectal cancer and (2) whether the intervention is more beneficial for men or for people who feel constrained in disclosing cancer-related concerns and feelings. Design Patients treated for colorectal cancer were randomized to an EW (n = 101) or control writing (CW; n = 92) group. Assessments were completed at 1 month pre- and post-intervention. Sex and perceived social constraints on disclosure were evaluated as moderators. Main Outcome Measures Primary outcomes were depressive symptoms, sleep problems and quality of life indicators. Results 81% of participants completed all writing assignments. Consistent with hypotheses, relative to the CW group, participants in the EW group expressed more emotion in writing and rated their writings as more meaningful, personal, and emotionally revealing. There were no significant main effects of EW or moderating effects of sex or social constraints on outcomes. Conclusions Although EW is feasible to use with persons who have colorectal cancer, it was not effective as a stand-alone psychotherapeutic intervention. Nor was it more effective for men or for people who felt they could not freely disclose cancer-related concerns and feelings. PMID:25271396

Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

Science.gov (United States)

De Oliveira, Gildasio S; Rodes, Meghan E; Bialek, Jane; Kendall, Mark C; McCarthy, Robert J

2017-11-15

Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory breast surgery. © 2017 Wiley Periodicals, Inc.

The high-precision x-ray tomograph for quality control of the ATLAS MDT muon spectrometer

CERN Document Server

Drakoulakos, D G; Maugain, J M; Rohrbach, F; Sedykh, Yu

1997-01-01

For the Large Hadron Collider (LHC) of the next millennium, a large general-purpose high-energy physics experiment, the ATLAS project, is being designed by a world-wide collaboration. One of its detectors, the ATLAS muon tracking detector, the MDT project, is on the scale of a very large industrial project: the design, the construction and assembly of twelve hundred large muon drift chambers are aimed at producing an exceptional quality in terms of accuracy, material reliability, assembly, and monitoring. This detector, based on the concept of very high mechanical precision required by the physics goals, will use tomography as a quality control platform. An X-ray tomograph prototype, monitored by a set of interferometers, has been developed at CERN to provide high-quality control of the MDT chambers which will be built in the collaborating institutes of the ATLAS project. First results have been obtained on MDT prototypes showing the validity of the X-ray tomograph approach for mechanical control of the detec...

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

Effects of exercise training with traditional dancing on functional capacity and quality of life in patients with schizophrenia: a randomized controlled study.

Science.gov (United States)

Kaltsatou, A; Kouidi, E; Fountoulakis, K; Sipka, C; Theochari, V; Kandylis, D; Deligiannis, A

2015-09-01

To examine the effects of an eight-month exercise training programme with Greek traditional dancing on functional capacity and quality of life in patients with schizophrenia. Randomized controlled trial. Sports Medicine Laboratory. A total of 31 patients, aged 59.9 ± 14.1 years. They were randomly assigned either to a Greek traditional dancing programme (Group A) or to a sedentary control group (Group B). A functional capacity assessment was performed at baseline and the end of the study. Global Assessment of Functioning Scale and Positive and Negative Syndrome Scale were also used. Quality of life was examined using the Quality of Life and Satisfaction questionnaire. After the eight months, Group A increased walking distance in the 6-minute walk test (328.4 ± 35.9 vs. 238.0 ± 47.6 m), sit-to-stand test (19.1 ± 1.8 vs. 25.1 ± 1.4 seconds), Berg Balance Scale score (53.1 ± 2.1 vs. 43.2 ± 6.7), lower limbs maximal isometric force (77.7 ± 25.7 vs. 51.0 ± 29.8 lb), Positive and Negative Syndrome Scale total score (77.0 ± 23.1 vs. 82.0 ± 24.4), Global Assessment of Functioning Scale total score (51.3 ± 15.5 vs. 47.7 ± 13.3) and Quality of Life total score (34.9 ± 5.2 vs. 28 ± 4.5), compared with Group B. Our results demonstrate that Greek traditional dances improve functional capacity and quality of life in patients with schizophrenia. © The Author(s) 2014.

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

Quality assurance and quality control

International Nuclear Information System (INIS)

Anon.

1987-01-01

The practice of nuclear diagnostic imaging requires an appropriate quality assurance program to attain high standards of efficiency and reliability. The International Atomic Energy Agency defines the term quality assurance as ''the closeness with which the outcome of a given procedure approaches some ideal, free from all errors and artifacts.'' The term quality control is used in reference to the specific measures taken to ensure that one particular aspect of the procedure is satisfactory. Therefore, quality assurance is a hospital-wide concept that should involve all aspects of clinical practice. Quality control is concerned with the submission of requests for procedures; the scheduling of patients; the preparation and dispensing of radiopharmaceuticals; the protection of patients, staff, and the general public against radiation hazards and accidents caused by radioactive materials or by faulty equipment; the setting up, use, and maintenance of electronic instruments; the methodology of the actual procedures; the analysis and interpretation of data; the reporting of results; and, finally, the keeping of records. The chapter discusses each of these areas

Cultivating teacher mindfulness: Effects of a randomized controlled trial on work, home, and sleep outcomes.

Science.gov (United States)

Crain, Tori L; Schonert-Reichl, Kimberly A; Roeser, Robert W

2017-04-01

The effects of randomization to a workplace mindfulness training (WMT) or a waitlist control condition on teachers' well-being (moods and satisfaction at work and home), quantity of sleep, quality of sleep, and sleepiness during the day were examined in 2 randomized, waitlist controlled trials (RCTs). The combined sample of the 2 RCTs, conducted in Canada and the United States, included 113 elementary and secondary school teachers (89% female). Measures were collected at baseline, postprogram, and 3-month follow-up; teachers were randomly assigned to condition after baseline assessment. Results showed that teachers randomized to WMT reported less frequent bad moods at work and home, greater satisfaction at work and home, more sleep on weekday nights, better quality sleep, and decreased insomnia symptoms and daytime sleepiness. Training-related group differences in mindfulness and rumination on work at home at postprogram partially mediated the reductions in negative moods at home and increases in sleep quality at follow-up. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Analytical method for high resolution liquid chromatography for quality control French Macaw

International Nuclear Information System (INIS)

Garcia Penna, Caridad M; Torres Amaro, Leonid; Menendez Castillo, Rosa; Sanchez, Esther; Martinez Espinosa, Vivian; Gonzalez, Maria Lidia; Rodriguez, Carlos

2007-01-01

Was developed and validated an analytical method for high resolution liquid chromatography applicable to quality control of drugs dry French Macaw (Senna alata L. Roxb.) With ultraviolet detection at 340 nm. The method for high resolution liquid chromatography used to quantify the sennosides A and B, main components, was validated and proved to be specific, linear, precise and accurate. (Author)

Sleep quality in patients with xerostomia: a prospective and randomized case-control study.

Science.gov (United States)

Lopez-Jornet, Pia; Lucero Berdugo, Maira; Fernandez-Pujante, Alba; C, Castillo Felipe; Lavella C, Zamora; A, Pons-Fuster; J, Silvestre Rangil; Silvestre, Francisco Javier

2016-01-01

Objectives To investigate sleep quality, anxiety/depression and quality-of-life in patients with xerostomia. Materials and methods This prospective, observational, cross-sectional study was conducted among a group of xerostomia patients (n = 30) compared with 30 matched control subjects. The following evaluation scales were used to assess the psychological profile of each patient: the Hospital Anxiety and Depression Scale, the Oral Health Impact Profile-14 (OHIP-14), the Xerostomia Inventory, the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Results The PSQI obtained 5.3 3 ± 1.78 for patients with xerostomia compared with 4.26 ± 1.01 for control subjects (p = 0.006); ESS obtained 5.7 ± 2.1 for test patients vs 4.4 0 ± 1 for control subjects (p = 0.010). Statistical regression analysis showed that xerostomia was significantly associated with depression (p = 0.027). Conclusions Patients with xerostomia exhibited significant decreases in sleep quality compared with control subjects.

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.

Improving elementary school quality through the use of a social-emotional and character development program: a matched-pair, cluster-randomized, controlled trial in Hawai'i.

Science.gov (United States)

Snyder, Frank J; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J; Flay, Brian R

2012-01-01

School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools and was conducted from 2002-2003 through 2005-2006. School-level archival data, collected by the Hawai'i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. © 2011, American School Health Association.

Impact of Scribes on Physician Satisfaction, Patient Satisfaction, and Charting Efficiency: A Randomized Controlled Trial.

Science.gov (United States)

Gidwani, Risha; Nguyen, Cathina; Kofoed, Alexis; Carragee, Catherine; Rydel, Tracy; Nelligan, Ian; Sattler, Amelia; Mahoney, Megan; Lin, Steven

2017-09-01

Scribes are increasingly being used in clinical practice despite a lack of high-quality evidence regarding their effects. Our objective was to evaluate the effect of medical scribes on physician satisfaction, patient satisfaction, and charting efficiency. We conducted a randomized controlled trial in which physicians in an academic family medicine clinic were randomized to 1 week with a scribe then 1 week without a scribe for the course of 1 year. Scribes drafted all relevant documentation, which was reviewed by the physician before attestation and signing. In encounters without a scribe, the physician performed all charting duties. Our outcomes were physician satisfaction, measured by a 5-item instrument that included physicians' perceptions of chart quality and chart accuracy; patient satisfaction, measured by a 6-item instrument; and charting efficiency, measured by time to chart close. Scribes improved all aspects of physician satisfaction, including overall satisfaction with clinic (OR = 10.75), having enough face time with patients (OR = 3.71), time spent charting (OR = 86.09), chart quality (OR = 7.25), and chart accuracy (OR = 4.61) (all P values patient satisfaction. Scribes increased the proportion of charts that were closed within 48 hours (OR =1.18, P =.028). To our knowledge, we have conducted the first randomized controlled trial of scribes. We found that scribes produced significant improvements in overall physician satisfaction, satisfaction with chart quality and accuracy, and charting efficiency without detracting from patient satisfaction. Scribes appear to be a promising strategy to improve health care efficiency and reduce physician burnout. © 2017 Annals of Family Medicine, Inc.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

Science.gov (United States)

Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

Isoflavones, calcium, vitamin D and inulin improve quality of life, sexual function, body composition and metabolic parameters in menopausal women: result from a prospective, randomized, placebo-controlled, parallel-group study.

Science.gov (United States)

Vitale, Salvatore Giovanni; Caruso, Salvatore; Rapisarda, Agnese Maria Chiara; Cianci, Stefano; Cianci, Antonio

2018-03-01

Menopause results in metabolic changes that contribute to increase risk of cardiovascular diseases: increase in low density lipoprotein (LDL) and triglycerides and decrease in high density lipoprotein (HDL), weight gain are associated with a correspondent increase in incidence of hypertension and diabetes. The aim of this study was to evaluate the effect of a preparation of isoflavones, calcium vitamin D and inulin in menopausal women. We performed a prospective, randomized, placebo-controlled, parallel-group study. A total of 50 patients were randomized to receive either oral preparations of isoflavones (40 mg), calcium (500 mg) vitamin D (300 UI) and inulin (3 g) or placebo (control group). Pre- and post-treatment assessment of quality of life and sexual function were performed through Menopause-Specific Quality of Life Questionnaire (MENQOL) and Female Sexual Function Index (FSFI); evaluations of anthropometric indicators, body composition through bioelectrical impedance analyser, lumbar spine and proximal femur T-score and lipid profile were performed. After 12 months, a significant reduction in MENQOL vasomotor, physical and sexual domain scores ( p 0.05) were found in the same group. According to our data analysis, isoflavones, calcium, vitamin D and inulin may exert favourable effects on menopausal symptoms and signs.

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.

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

Electronic adherence monitoring device performance and patient acceptability: a randomized control trial.

Science.gov (United States)

Chan, Amy Hai Yan; Stewart, Alistair William; Harrison, Jeff; Black, Peter Nigel; Mitchell, Edwin Arthur; Foster, Juliet Michelle

2017-05-01

To investigate the performance and patient acceptability of an inhaler electronic monitoring device in a real-world childhood asthma population. Children 6 to 15 years presenting with asthma to the hospital emergency department and prescribed inhaled corticosteroids were included. Participants were randomized to receive a device with reminder features enabled or disabled for use with their preventer. Device quality control tests were conducted. Questionnaires on device acceptability, utility and ergonomics were completed at six months. A total of 1306 quality control tests were conducted; 84% passed pre-issue and 87% return testing. The most common failure reason was actuation under-recording. Acceptability scores were high, with higher scores in the reminder than non-reminder group (median, 5 th -95 th percentile: 4.1, 3.1-5.0 versus 3.7, 2.3-4.8; p 90%) rated the device easy to use. Feedback was positive across five themes: device acceptability, ringtone acceptability, suggestions for improvement, effect on medication use, and effect on asthma control. This study investigates electronic monitoring device performance and acceptability in children using quantitative and qualitative measures. Results indicate satisfactory reliability, although failure rates of 13-16% indicate the importance of quality control. Favorable acceptability ratings support the use of these devices in children.

Effect of uncertainty components such as recalibration on the performance of quality control charts

DEFF Research Database (Denmark)

Winkel, P; Zhang, Nevin

2005-01-01

Uncertainty components (recalibration, new reagent lots, etc.) may be the source of random changes in the level of quality control (QC) values, thus causing false alarms. We propose a method for reducing false alarms.......Uncertainty components (recalibration, new reagent lots, etc.) may be the source of random changes in the level of quality control (QC) values, thus causing false alarms. We propose a method for reducing false alarms....

High-power random distributed feedback fiber laser: From science to application

Energy Technology Data Exchange (ETDEWEB)

Du, Xueyuan [College of Optoelectronic Science and Engineering, National University of Defense Technology, Changsha 410073 (China); Naval Academy of Armament, Beijing 100161 (China); Zhang, Hanwei; Xiao, Hu; Ma, Pengfei; Wang, Xiaolin; Zhou, Pu; Liu, Zejin [College of Optoelectronic Science and Engineering, National University of Defense Technology, Changsha 410073 (China)

2016-10-15

A fiber laser based on random distributed feedback has attracted increasing attention in recent years, as it has become an important photonic device and has found wide applications in fiber communications or sensing. In this article, recent advances in high-power random distributed feedback fiber laser are reviewed, including the theoretical analyses, experimental approaches, discussion on the practical applications and outlook. It is found that a random distributed feedback fiber laser can not only act as an information photonics device, but also has the feasibility for high-efficiency/high-power generation, which makes it competitive with conventional high-power laser sources. In addition, high-power random distributed feedback fiber laser has been successfully applied for midinfrared lasing, frequency doubling to the visible and high-quality imaging. It is believed that the high-power random distributed feedback fiber laser could become a promising light source with simple and economic configurations. (copyright 2016 by WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim)

Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.

Science.gov (United States)

Holbrook, Janet T; Wise, Robert A; Gold, Benjamin D; Blake, Kathryn; Brown, Ellen D; Castro, Mario; Dozor, Allen J; Lima, John J; Mastronarde, John G; Sockrider, Marianna M; Teague, W Gerald

2012-01-25

Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control. To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization. Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157). The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control. The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for

Sleep Quality Effects Recovery After Total Knee Arthroplasty (TKA)--A Randomized, Double-Blind, Controlled Study.

Science.gov (United States)

Gong, Long; Wang, ZhenHu; Fan, Dong

2015-11-01

This study examined the effects of sleep quality on early recovery after total knee arthroplasty. A total of 148 patients were randomized 1:1 to receive either zolpidem or placebo for 2 weeks. VAS pain scores (rest, ambulation and night), range of motion (ROM), total amount of opioid analgesics and antiemetics taken, postoperative nausea and vomiting (PONV), sleep efficacy and satisfaction were recorded. It was found that patients taking zolpidem achieved greater improvement in quality of life and reported better satisfaction. Patients in the intervention group had lower pain score and took less antiemetics. Moreover, a significant correlation between sleep quality and ROM was detected. These results demonstrated that improved sleep quality is beneficial to patients' post-TKA recovery. Copyright © 2015. Published by Elsevier Inc.

Effect of intra-operative high inspired oxygen fraction on surgical site infection: a meta-analysis of randomized controlled trials.

Science.gov (United States)

Yang, W; Liu, Y; Zhang, Y; Zhao, Q-H; He, S-F

2016-08-01

Surgical site infection (SSI) causes significant mortality and morbidity. Administration of a high inspired oxygen fraction (FiO2) to patients undergoing surgery may represent a potential preventive strategy. To conduct a meta-analysis of randomized controlled trials in which high FiO2 was compared with normal FiO2 in patients undergoing surgery to estimate the effect on the development of SSI. A comprehensive search was undertaken for randomized controlled trials (until December 2015) that compared high FiO2 with normal FiO2 in adults undergoing surgery with general anaesthesia and reported on SSI. This study included 17 randomized controlled trials with 8093 patients. Infection rates were 13.11% in the control group and 11.53% in the hyperoxic group, while the overall risk ratio was 0.893 [95% confidence interval (CI) 0.794-1.003; P = 0.057]. Subgroup analyses stratified by country, definition of SSI, and type of surgery were also performed, and showed similar results. However, high FiO2 was found to be of significant benefit in patients undergoing colorectal surgery, with a risk ratio of 0.735 (95% CI 0.573-0.944; P=0.016). There is moderate evidence to suggest that administration of high FiO2 to patients undergoing surgery, especially colorectal surgery, reduces the risk of SSI. Further studies with better adherence to the intervention may affect the results of this meta-analysis. Copyright © 2016 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Dynamic Output Feedback Control for Nonlinear Networked Control Systems with Random Packet Dropout and Random Delay

Directory of Open Access Journals (Sweden)

Shuiqing Yu

2013-01-01

Full Text Available This paper investigates the dynamic output feedback control for nonlinear networked control systems with both random packet dropout and random delay. Random packet dropout and random delay are modeled as two independent random variables. An observer-based dynamic output feedback controller is designed based upon the Lyapunov theory. The quantitative relationship of the dropout rate, transition probability matrix, and nonlinear level is derived by solving a set of linear matrix inequalities. Finally, an example is presented to illustrate the effectiveness of the proposed method.

High Quality Model Predictive Control for Single Phase Grid Connected Photovoltaic Inverters

DEFF Research Database (Denmark)

Zangeneh Bighash, Esmaeil; Sadeghzadeh, Seyed Mohammad; Ebrahimzadeh, Esmaeil

2018-01-01

Single phase grid-connected inverters with LCL filter are widely used to connect the photovoltaic systems to the utility grid. Among the presented control schemes, predictive control methods are faster and more accurate but are more complex to implement. Recently, the model-predictive control...... algorithm for single-phase inverter has been presented, where the algorithm implementation is straightforward. In the proposed approach, all switching states are tested in each switching period to achieve the control objectives. However, since the number of the switching states in single-phase inverter...... is low, the inverter output current has a high total harmonic distortions. In order to reduce the total harmonic distortions of the injected current, this paper presents a high-quality model-predictive control for one of the newest structure of the grid connected photovoltaic inverter, i.e., HERIC...

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

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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)…

Quality control of mammography

International Nuclear Information System (INIS)

Hering, K.G.

1986-01-01

Random checks of mammograms allow to clearly assess quality controls concerning correct application and operation of the radiographic system indicated by rich contrast in breast tissue images, complete imaging of the mammary parenchyma, freedom from blurs due to motion, efficient breast compression, correct film labelling and perfect maintenance of the film screen system. In addition to these subjective assessments, the following points should be considered when using objective measurement procedures and phantoms: Testing the correct function of X-ray and radiographic equipment by means of test specimens to measure KV standard (KV=Association of German Panel Doctors), mAS and automatic exposure timer; comparing dose and density to initial values and checking film processing by using a sensitometer. Quality assurance handling varies from one KV to the next. That is why the users need to obtain the guidelines of the respective KV relative to radiological quality assurance and to proceed according to these. (orig.) [de

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

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

2015-03-13

The burden of cancer is increasing; projections over the next 2 decades suggest that the annual cases of cancer will rise from 14 million in 2012 to 22 million. However, cancer patients in the 21st century are living longer due to the availability of novel therapeutic regimens, which has prompted a growing focus on maintaining patients' health-related quality of life. Telehealth is increasingly being used to connect with patients outside of traditional clinical settings, and early work has shown its importance in improving quality of life and other clinical outcomes in cancer care. The aim of this study was to systematically assess the literature for the effect of supportive telehealth interventions on pain, depression, and quality of life in cancer patients via a systematic review of clinical trials. We searched PubMed, EMBASE, Google Scholar, CINAHL, and PsycINFO in July 2013 and updated the literature search again in January 2015 for prospective randomized trials evaluating the effect of telehealth interventions in cancer care with pain, depression, and quality of life as main outcomes. Two of the authors independently reviewed and extracted data from eligible randomized controlled trials, based on pre-determined selection criteria. Methodological quality of studies was assessed by the Cochrane Collaboration risk of bias tool. Of the 4929 articles retrieved from databases and relevant bibliographies, a total of 20 RCTs were included in the final review. The studies were largely heterogeneous in the type and duration of the intervention as well as in outcome assessments. A majority of the studies were telephone-based interventions that remotely connected patients with their health care provider or health coach. The intervention times ranged from 1 week to 12 months. In general, most of the studies had low risk of bias across the domains of the Cochrane Collaboration risk of bias tool, but most of the studies had insufficient information about the allocation

Statistical process control for radiotherapy quality assurance

International Nuclear Information System (INIS)

Pawlicki, Todd; Whitaker, Matthew; Boyer, Arthur L.

2005-01-01

Every quality assurance process uncovers random and systematic errors. These errors typically consist of many small random errors and a very few number of large errors that dominate the result. Quality assurance practices in radiotherapy do not adequately differentiate between these two sources of error. The ability to separate these types of errors would allow the dominant source(s) of error to be efficiently detected and addressed. In this work, statistical process control is applied to quality assurance in radiotherapy for the purpose of setting action thresholds that differentiate between random and systematic errors. The theoretical development and implementation of process behavior charts are described. We report on a pilot project is which these techniques are applied to daily output and flatness/symmetry quality assurance for a 10 MV photon beam in our department. This clinical case was followed over 52 days. As part of our investigation, we found that action thresholds set using process behavior charts were able to identify systematic changes in our daily quality assurance process. This is in contrast to action thresholds set using the standard deviation, which did not identify the same systematic changes in the process. The process behavior thresholds calculated from a subset of the data detected a 2% change in the process whereas with a standard deviation calculation, no change was detected. Medical physicists must make decisions on quality assurance data as it is acquired. Process behavior charts help decide when to take action and when to acquire more data before making a change in the process

High cardiac vagal control is related to better subjective and objective sleep quality.

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Werner, Gabriela G; Ford, Brett Q; Mauss, Iris B; Schabus, Manuel; Blechert, Jens; Wilhelm, Frank H

2015-03-01

Cardiac vagal control (CVC) has been linked to both physical and mental health. One critical aspect of health, that has not received much attention, is sleep. We hypothesized that adults with higher CVC--operationalized by high-frequency heart rate variability (HF-HRV)--will exhibit better sleep quality assessed both subjectively (i.e., with Pittsburgh Sleep Quality Index) and objectively (i.e., with polysomnography). HF-HRV was measured in 29 healthy young women during an extended neutral film clip. Participants then underwent full polysomnography to obtain objective measures of sleep quality and HF-HRV during a night of sleep. As expected, higher resting HF-HRV was associated with higher subjective and objective sleep quality (i.e., shorter sleep latency and fewer arousals). HF-HRV during sleep (overall or separated by sleep phases) showed less consistent relationships with sleep quality. These findings indicate that high waking CVC may be a key predictor of healthy sleep. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

The application of statistical process control in linac quality assurance

International Nuclear Information System (INIS)

Li Dingyu; Dai Jianrong

2009-01-01

Objective: To improving linac quality assurance (QA) program with statistical process control (SPC) method. Methods: SPC is applied to set the control limit of QA data, draw charts and differentiate the random and systematic errors. A SPC quality assurance software named QA M ANAGER has been developed by VB programming for clinical use. Two clinical cases are analyzed with SPC to study daily output QA of a 6MV photon beam. Results: In the clinical case, the SPC is able to identify the systematic errors. Conclusion: The SPC application may be assistant to detect systematic errors in linac quality assurance thus it alarms the abnormal trend to eliminate the systematic errors and improves quality control. (authors)

Effect of mindfulness and yoga on quality of life for elementary school students and teachers: results of a randomized controlled school-based study

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Bazzano AN

2018-04-01

Full Text Available Alessandra N Bazzano,1 Christopher E Anderson,2 Chelsea Hylton,3 Jeanette Gustat2 1Department of Global Community Health and Behavioral Sciences, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA; 2Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA; 3Project Peaceful Warriors, New Orleans, LA, USA Objective: To assess the impact of a yoga curriculum in an elementary school on student quality of life, and to assess teacher and staff perception of potential barriers to, and benefits of, introducing yoga and mindfulness into the classroom.Methods: A randomized controlled trial was utilized to assess the impact of a brief intervention on third-grade students who screened positive for symptoms of anxiety. Students were randomized to an intervention group of 20 students receiving small-group yoga/mindfulness activities for 8 weeks between October 2016 and February 2017, and a control group of 32 students receiving care as usual. The Brief Multidimensional Students’ Life Satisfaction Scale-Peabody Treatment Progress Battery and the Pediatric Quality of Life Inventory (PedsQL served as outcomes. Teachers were invited to participate in two professional development sessions about introducing yoga and mindfulness into the classroom, and completed a survey following each of the sessions.Results: In generalized estimating equation models adjusted for time, the yoga-based intervention was associated with a 14.17 unit increase in student emotional PedsQL (p-value 0.001 and a 7.43 unit increase in psychosocial PedsQL (p-value 0.01. Results were not attenuated by adjustment. Teachers and staff reported using yoga more frequently in the classroom following the second of two professional development sessions (p-value <0.05. Perceived barriers to introducing yoga to the classroom were similar at two data collection time points, while perceived benefits remained high

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

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Durand, Marie-Anne; Gates, Bob; Parkes, Georgina; Zia, Asif; Friedli, Karin; Barton, Garry; Ring, Howard; Oostendorp, Linda; Wellsted, David

2014-11-20

Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of

Effects of gut-directed hypnotherapy on IBS in different clinical settings-results from two randomized, controlled trials.

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Lindfors, Perjohan; Unge, Peter; Arvidsson, Patrik; Nyhlin, Henry; Björnsson, Einar; Abrahamsson, Hasse; Simrén, Magnus

2012-02-01

Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome (IBS). However, randomized, controlled studies are rare and few have been performed outside highly specialized research centers. The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical settings outside the traditional research units. The study population included IBS patients refractory to standard management. In study 1, patients were randomized to receive gut-directed hypnotherapy (12 sessions, 1 h/week) in psychology private practices or supportive therapy, whereas patients were randomized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2. Gastrointestinal symptom severity and quality of life were evaluated at baseline, at 3 months follow-up and after 1 year. We randomized 138 IBS patients refractory to standard management, 90 in study 1 and 48 in study 2. In both the studies, IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups (Phypnotherapy group than in the control group (Phypnotherapy is an effective treatment alternative for patients with refractory IBS, but the effectiveness is lower when the therapy is given outside the highly specialized research centers.

Randomized Controlled Trial of "Mind Reading" and In Vivo Rehearsal for High-Functioning Children with ASD

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Thomeer, Marcus L.; Smith, Rachael A.; Lopata, Christopher; Volker, Martin A.; Lipinski, Alanna M.; Rodgers, Jonathan D.; McDonald, Christin A.; Lee, Gloria K.

2015-01-01

This randomized controlled trial evaluated the efficacy of a computer software (i.e., "Mind Reading") and in vivo rehearsal treatment on the emotion decoding and encoding skills, autism symptoms, and social skills of 43 children, ages 7-12 years with high-functioning autism spectrum disorder (HFASD). Children in treatment (n = 22)…

A randomized controlled trial of intensive care management for disabled Medicaid beneficiaries with high health care costs.

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Bell, Janice F; Krupski, Antoinette; Joesch, Jutta M; West, Imara I; Atkins, David C; Court, Beverly; Mancuso, David; Roy-Byrne, Peter

2015-06-01

To evaluate outcomes of a registered nurse-led care management intervention for disabled Medicaid beneficiaries with high health care costs. Washington State Department of Social and Health Services Client Outcomes Database, 2008-2011. In a randomized controlled trial with intent-to-treat analysis, outcomes were compared for the intervention (n = 557) and control groups (n = 563). A quasi-experimental subanalysis compared outcomes for program participants (n = 251) and propensity score-matched controls (n = 251). Administrative data were linked to describe costs and use of health services, criminal activity, homelessness, and death. In the intent-to-treat analysis, the intervention group had higher odds of outpatient mental health service use and higher prescription drug costs than controls in the postperiod. In the subanalysis, participants had fewer unplanned hospital admissions and lower associated costs; higher prescription drug costs; higher odds of long-term care service use; higher drug/alcohol treatment costs; and lower odds of homelessness. We found no health care cost savings for disabled Medicaid beneficiaries randomized to intensive care management. Among participants, care management may have the potential to increase access to needed care, slow growth in the number and therefore cost of unplanned hospitalizations, and prevent homelessness. These findings apply to start-up care management programs targeted at high-cost, high-risk Medicaid populations. © Health Research and Educational Trust.

A Randomized, Double-blind, Placebo-controlled Clinical Trial Examining the Effects of Green Tea Extract on Systemic Lupus Erythematosus Disease Activity and Quality of Life.

Science.gov (United States)

Shamekhi, Z; Amani, R; Habibagahi, Z; Namjoyan, F; Ghadiri, Ata; Saki Malehi, A

2017-07-01

Antiinflammatory and immunomodulatory benefit of green tea (Camellia sinensis) in autoimmune disease has been proven in recent studies. The objective of this study was to assess the effects of green tea on disease activity and quality of life in systemic lupus erythematosus patients. A randomized controlled trial on subjects with lupus was conducted, and 68 patients in the age range of 39.1 ± 10.3 years and body mass index of 25.7 ± 5.21 kg/m 2 completed the 12-week study. Patients were randomly divided into two groups of intervention (1000 mg green tea extract, two capsules/day) and control (1000 mg of starch, two capsules/day). Main outcome measure, systemic lupus erythematosus disease activity, was assessed by the systemic lupus erythematosus disease activity index at the first and after 3 months of intervention. In addition, patient's quality of life was evaluated by short form of quality-of-life questionnaire at baseline and after 3 months. Green tea extract supplementation significantly reduced disease activity in lupus patients (p tea extracts for 12 weeks improves the systemic lupus erythematosus disease activity as well as some aspects of quality of life. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Regional quality control survey of blood-gas analysis.

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Minty, B D; Nunn, J F

1977-09-01

We undertook an external quality control survey of blood-gas analysis in 16 laboratories at 13 hospitals. All samples were prepared in the laboratories under investigation by equilibration of blood or serum with gas mixtures of known composition. pH of serum was measured with no significant bias but with an SD of random error 0.026 pH units, which was almost twice the SD of the reference range (0.015). An acceptable random error (half SD of reference range) was not obtained in a longitudinal internal quality control suvey although there were acceptable results for buffer pH in both field and internal surveys. Blood PO2 was measured with no significant bias but with SD of random error 1.38 kPa which reduced to 0.72 kPa by excluding one egregious result. The latter value was just over half of the SD of the reference range (1.2 kPa). PCO2 of blood was also measured without significant bias but with a much smaller SD of random error of 0.28 kPa (by excluding one egregious result), which was again just over half the SD of the reference range (0.51 kPa). Measurements of blood PO2 and PCO2 seem generally acceptable in relation to their respective reference ranges but measurements of pH were unsatisfactory in both internal and external trials.

A school-based randomized controlled trial to improve physical activity among Iranian high school girls

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Ghofranipour Fazloalha

2008-04-01

Full Text Available Abstract Background Physical activity (PA rates decline precipitously during the high school years and are consistently lower among adolescent girls than adolescent boys. Due to cultural barriers, this problem might be exacerbated in female Iranian adolescents. However, little intervention research has been conducted to try to increase PA participation rates with this population. Because PA interventions in schools have the potential to reach many children and adolescents, this study reports on PA intervention research conducted in all-female Iranian high schools. Methods A randomized controlled trial was conducted to examine the effects of two six-month tailored interventions on potential determinants of PA and PA behavior. Students (N = 161 were randomly allocated to one of three conditions: an intervention based on Pender's Health Promotion model (HP, an intervention based on an integration of the health promotion model and selected constructs from the Transtheoretical model (THP, and a control group (CON. Measures were administered prior to the intervention, at post-intervention and at a six-month follow-up. Results Repeated measure ANOVAs showed a significant interaction between group and time for perceived benefits, self efficacy, interpersonal norms, social support, behavioral processes, and PA behavior, indicating that both intervention groups significantly improved across the 24-week intervention, whereas the control group did not. Participants in the THP group showed greater use of counter conditioning and stimulus control at post-intervention and at follow-up. While there were no significant differences in PA between the HP and CON groups at follow-up, a significant difference was still found between the THP and the CON group. Conclusion This study provides the first evidence of the effectiveness of a PA intervention based on Pender's HP model combined with selected aspects of the TTM on potential determinants to increase PA among

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

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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

Evaluation of quality improvement performance in the Community Diabetes Education (CoDE) program for uninsured Mexican Americans: results of a randomized controlled trial.

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Prezio, Elizabeth A; Balasubramanian, Bijal A; Shuval, Kerem; Cheng, Dunlei; Kendzor, Darla E; Culica, Dan

2014-01-01

The objective of this article is to quantify quality improvement using data from a randomized controlled trial that tested the effectiveness of a community health worker in the primary role of diabetes educator in a clinic serving uninsured Mexican Americans. The intervention group received 7 hours of diabetes education/case management in excess of usual medical care. Of 16 process and outcome measures evaluated, the intervention group was significantly more likely to have received a dilated retinal examination, and 53% achieved a hemoglobin A1c below 7% compared with 38% of the control group participants. Composite quality measures were similar in magnitude with published practice-based benchmarks at study conclusion. This suggests that the overall diabetes care delivered in this clinic serving uninsured patients was comparable to the levels of excellence achieved in other primary care settings. Quantitative measurements of quality improvement can inform health policy regarding the relative effectiveness of diabetes interventions.

A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis.

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Turner, Abigail Norris; Carr Reese, Patricia; Fields, Karen S; Anderson, Julie; Ervin, Melissa; Davis, John A; Fichorova, Raina N; Roberts, Mysheika Williams; Klebanoff, Mark A; Jackson, Rebecca D

2014-11-01

Low serum vitamin D levels have been associated with increased prevalence of the reproductive tract condition bacterial vaginosis (BV). The objective of this trial was to evaluate the effect of high-dose vitamin D supplementation on BV recurrence. This randomized, placebo-controlled, double-blinded trial enrolled 118 women with symptomatic BV from an urban sexually transmitted disease clinic (clinicaltrials.gov registration NCT01450462). All participants received 500 mg of oral metronidazole twice daily for 7 days. Intervention participants (n = 59) also received 9 doses of 50,000 IU of cholecalciferol (vitamin D3) over 24 weeks; control women (n = 59) received matching placebo. Recurrent BV was assessed via Nugent scoring after 4, 12, and 24 weeks. We assessed the effect of the intervention using an intention-to-treat approach, fitting Cox proportional hazards models to evaluate recurrent BV over the follow-up period. Most participants (74%) were black, with a median age of 26 years. Median presupplementation serum 25-hydroxyvitamin D [25(OH)D] was similar across randomization arms: 16.6 ng/mL in the vitamin D arm and 15.8 ng/mL in the control arm. At trial completion, median 25(OH)D among women receiving vitamin D was 30.5 ng/mL, vs 17.8 ng/mL in control women; 16% of women receiving vitamin D and 57% receiving placebo remained vitamin D deficient (<20 ng/mL). BV prevalence among women randomized to vitamin D was very similar to those randomized to placebo at the 4- and 12-week visits, but by the 24-week visit, BV prevalence was 65% among women in the vitamin D arm and 48% among control women. BV recurrence was not reduced by vitamin D supplementation (intention-to-treat hazard ratio, 1.11; 95% confidence interval, 0.68-1.81). Among women experiencing recurrent BV, median time to recurrence was 13.7 weeks in the vitamin D arm and 14.3 weeks in the control arm. Women receiving vitamin D experienced significant increases in serum 25(OH)D, but this increase was not

How to Measure Motivational Interviewing Fidelity in Randomized Controlled Trials: Practical Recommendations.

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Jelsma, Judith G M; Mertens, Vera-Christina; Forsberg, Lisa; Forsberg, Lars

2015-07-01

Many randomized controlled trials in which motivational interviewing (MI) is a key intervention make no provision for the assessment of treatment fidelity. This methodological shortcoming makes it impossible to distinguish between high- and low-quality MI interventions, and, consequently, to know whether MI provision has contributed to any intervention effects. This article makes some practical recommendations for the collection, selection, coding and reporting of MI fidelity data, as measured using the Motivational Interviewing Treatment Integrity Code. We hope that researchers will consider these recommendations and include MI fidelity measures in future studies. Copyright © 2015 Elsevier Inc. All rights reserved.

Impact of complete bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy: a randomized, controlled, single blind trial.

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Nyarangi-Dix, Joanne N; Radtke, Jan Philipp; Hadaschik, Boris; Pahernik, Sascha; Hohenfellner, Markus

2013-03-01

We investigated the influence of bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy. A total of 208 men who presented for radical prostatectomy were randomized to complete bladder neck preservation with subsequent urethro-urethral anastomosis or to no preservation as controls. Patients with failed bladder neck preservation were not included in study. We documented objective continence by the 24-hour pad test, social continence by the number of pads per day and quality of life outcomes by the validated Incontinence Quality of Life questionnaire in a single blind setting. Cancer resection was assessed by surgical margin status. At 0, 3, 6 and 12 months mean urine loss in the control vs the bladder neck preservation group was 713.3 vs 237.0, 49.6 vs 15.6, 44.4 vs 5.5 and 25.4 vs 3.1 gm, respectively (each p <0.001). At 3, 6 and 12 months in the control vs the preservation group the social continence rate was 55.3% vs 84.2% (p <0.001), 74.8% vs 89.5% (p = 0.05) and 81.4% vs 94.7% (p = 0.027), and the quality of life score was 80.4 vs 90.3 (p <0.001), 85.4 vs 91.7 (p = 0.016) and 86.0 vs 93.8 (p = 0.001), respectively. We noted significantly less urine loss, higher objective and social continence rates, and higher quality of life scores after complete bladder neck preservation at all followup points. On multiple logistic regression analysis complete bladder neck preservation was an independent positive predictor of continence. No significant difference was found in surgical margin status between the control and bladder neck preservation groups (12.5% vs 14.7%, p = 0.65). In what is to our knowledge the first prospective, randomized, controlled, single blind trial complete bladder neck preservation during radical prostatectomy was associated with a significantly higher urinary continence rate and increased patient satisfaction without compromising resection margins. Copyright © 2013 American Urological

Shared Care in Monitoring Stable Glaucoma Patients: A Randomized Controlled Trial

NARCIS (Netherlands)

Holtzer-Goor, Kim M.; van Vliet, Ellen J.; van Sprundel, Esther; Plochg, Thomas; Koopmanschap, Marc A.; Klazinga, Niek S.; Lemij, Hans G.

2016-01-01

Comparing the quality of care provided by a hospital-based shared care glaucoma follow-up unit with care as usual. This randomized controlled trial included stable glaucoma patients and patients at risk for developing glaucoma. Patients in the Usual Care group (n=410) were seen by glaucoma

Impact of a Mindfulness-Based Weight-Loss Intervention on Sleep Quality Among Adults with Obesity: Data from the SHINE Randomized Controlled Trial.

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Adler, Elizabeth; Dhruva, Anand; Moran, Patricia J; Daubenmier, Jennifer; Acree, Michael; Epel, Elissa S; Bacchetti, Peter; Prather, Aric A; Mason, Ashley; Hecht, Frederick M

2017-03-01

Sleep disturbance is a common problem among adults with obesity. Mindfulness interventions have been shown to improve sleep quality in various populations but have not been investigated in adults with obesity. The aim of this study was to compare the effects of a mindfulness-based weight-loss intervention with an active control on self-reported sleep quality among adults with obesity. This study was a secondary analysis of a randomized controlled trial and included 194 adults with a body mass index in the range 30-45 kg/m 2 . The treatment intervention included mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR). Both groups received identical diet and exercise guidelines in 17 group sessions conducted over 5.5 months that were matched for time, attention, and social support. The primary outcome of this analysis was between-group change in self-reported sleep quality, which was assessed using the Pittsburgh Sleep Quality Index (PSQI) global score at baseline and at 6, 12, and 18 months. Between-group differences in mean PSQI change scores in the mindfulness group (n = 100) compared to the control group (n = 94) were -0.27 (-0.68, 1.22; p = 0.58) at 6 months, -0.57 (-0.35, 1.50; p = 0.22) at 12 months, and -0.50 (-0.53, 1.53; p = 0.34) at 18 months, all in the direction of more sleep improvement in the mindfulness group but none reaching statistical significance. In the mindfulness group, average weekly minutes of meditation practice time was associated with improved sleep quality from baseline to 6 months. No statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR. Within the mindfulness group, average weekly minutes of mindfulness practice was associated with improved sleep quality.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial

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Mash Bob

2012-12-01

Full Text Available Abstract Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Methods Trial design: Pragmatic cluster randomized controlled trial Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. Objective: To evaluate the effectiveness of the group diabetes education programme Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life Randomisation: Computer generated random numbers Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation Numbers randomized: Seventeen health centres (34 in total will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. Discussion The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can

Effectiveness of Moxibustion Treatment in Quality of Life in Patients with Knee Osteoarthritis: A Randomized, Double-Blinded, Placebo-Controlled Trial

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Xiumei Ren

2015-01-01

Full Text Available Objective. To observe the effects of traditional Chinese moxibustion, compared with sham moxibustion, on the quality of life (QOL in patients with chronic knee osteoarthritis (KOA. Methods. This is a randomized double-blinded, placebo-controlled trial. 150 patients with KOA were randomly allocated to either a true moxibustion treatment (n = 77 or a sham moxibustion treatment (n = 73 three times a week for six weeks. The QOL of patients was evaluated with SF-36 at baseline and 3, 6, and 12 weeks after baseline. Results. 136 patients were available for analysis. Participants in the true moxibustion group experienced statistically significantly greater improvement in GH (general health scores than the sham group at week 6 (P = 0.015 and week 12 (P = 0.029. Participants in the true moxibustion group experienced statistically significantly greater improvement in VT (vitality scores than the sham group at week 12 (P = 0.042. No significant adverse effects were found during the trial. Conclusion. A 6-week moxibustion treatment seems to improve general health and vitality, which are associated with physical and mental quality of life, in patients with KOA up to 12 weeks, relative to credible sham moxibustion. This trial is registered with Clinicaltrials.gov ISRCTN68475405.

Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial

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Andrew Scholey

2017-02-01

Full Text Available Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6, in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171 were randomized (1:1 to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in and/or short duration of treatment may have masked a potential beneficial effect on sleep quality.

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

Compliance, clinical outcome, and quality of life of patients with stable angina pectoris receiving once-daily betaxolol versus twice daily metoprolol: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Przemyslaw Kardas

2007-05-01

Full Text Available Przemyslaw KardasThe First Department of Family Medicine, Medical University of LodzBackground: A randomized, controlled trial was conducted in an outpatient setting to examine the effect of beta-blocker dosing frequency on patient compliance, clinical outcome, and health-related quality of life in patients with stable angina pectoris.Methods: One hundred and twelve beta-blockers-naive outpatients with stable angina pectoris were randomized to receive betaxolol, 20 mg once daily or metoprolol tartrate, 50 mg twice daily for 8 weeks. The principal outcome measure was overall compliance measured electronically, whereas secondary outcome measures were drug effectiveness and health-related quality of life.Results: The overall compliance was 86.5 ± 21.3% in the betaxolol group versus 76.1 ± 26.3% in the metoprolol group (p < 0.01, and the correct number of doses was taken on 84.4 ± 21.6% and 64.0 ± 31.7% of treatment days, respectively (p < 0.0001. The percentage of missed doses was 14.5 ± 21.5% in the once-daily group and 24.8 ± 26.4% in the twice-daily group (p < 0.01. The percentage of doses taken in the correct time window (58.6% vs 42.0%, p = 0.01, correct interdose intervals (77.4% v 53.1%, p < 0.0001, and therapeutic coverage (85.6% vs 73.7%, p < 0.001 were significantly higher in the once-daily group. Both studied drugs had similar antianginal effectiveness. Health-related quality of life improved in both groups, but this increase was more pronounced in the betaxolol arm in some dimensions.Conclusions: The study demonstrates that patient compliance with once-daily betaxolol is significantly better than with twice daily metoprolol. Similarly, this treatment provides better quality of life. These results demonstrate possible therapeutic advantages of once-daily over twice-daily beta-blockers in the treatment of stable angina pectoris.Keywords: patient compliance, quality of life, stable angina pectoris, randomized controlled trial

Spiritual Therapy to Improve the Spiritual Well-Being of Iranian Women with Breast Cancer: A Randomized Controlled Trial

OpenAIRE

Jafari, Najmeh; Farajzadegan, Ziba; Zamani, Ahmadreza; Bahrami, Fatemeh; Emami, Hamid; Loghmani, Amir; Jafari, Nooshin

2013-01-01

Purpose. The aim of this study was to investigate the role of spiritual therapy intervention in improving the spiritual well-being and quality of life (QOL) of Iranian women with breast cancer. Methods. This randomized controlled clinical trial (RCT) recruited 65 women with breast cancer, randomly assigned to a 6-week spirituality-based intervention (n = 34) or control group (n = 31). Before and after six-week spiritual therapy intervention, spiritual well-being and quality of life (QOL) were...

Long-term effects of an occupational health guideline on employees' body weight-related outcomes, cardiovascular disease risk factors, and quality of life: Results from a randomized controlled trial

NARCIS (Netherlands)

Verweij, L.M.; Proper, K.I.; Weel, A.N.H.; Hulshof, C.T.J.; Mechelen, W. van

2013-01-01

Objective This study aims to evaluate the effectiveness of a draft occupational health guideline, aimed at preventing weight gain, on employees' body weight-related outcomes, cardiovascular disease (CVD) risk factors, and quality of life. Methods In a cluster randomized controlled trial including 16

Synthesis of results of randomized controlled trials of contrast media

International Nuclear Information System (INIS)

Kinnison, M.L.; Powe, N.R.; Steinberg, E.P.

1988-01-01

The authors review 100 randomized controlled trials (RCTs) that examine the safety or efficacy of new low-osmolality contrast media (LOM) and focus on the 43 RCTs judged to be of the highest quality. These RCTs showed no consistent differences in nephrotoxicity between high- and low-osmolality contrast media. Certain cardiovascular parameters were altered less with low-osmolality agents during intracardiac injection, but the clinical significance of these differences in unclear. Heat and pain sensations occurred less often with low-osmolality contrast media. No differences were noted in the incidence of nausea, vomiting, urticaria, or bronchospasm. Even with numerous RCTs comparing these media, physicians still must make economically significant choices about contrast media without sufficient data about their relative safety

Applying STOPP Guidelines in Primary Care Through Electronic Medical Record Decision Support: Randomized Control Trial Highlighting the Importance of Data Quality.

Science.gov (United States)

Price, Morgan; Davies, Iryna; Rusk, Raymond; Lesperance, Mary; Weber, Jens

2017-06-15

Potentially Inappropriate Prescriptions (PIPs) are a common cause of morbidity, particularly in the elderly. We sought to understand how the Screening Tool of Older People's Prescriptions (STOPP) prescribing criteria, implemented in a routinely used primary care Electronic Medical Record (EMR), could impact PIP rates in community (non-academic) primary care practices. We conducted a mixed-method, pragmatic, cluster, randomized control trial in research naïve primary care practices. Phase 1: In the randomized controlled trial, 40 fully automated STOPP rules were implemented as EMR alerts during a 16-week intervention period. The control group did not receive the 40 STOPP rules (but received other alerts). Participants were recruited through the OSCAR EMR user group mailing list and in person at user group meetings. Results were assessed by querying EMR data PIPs. EMR data quality probes were included. Phase 2: physicians were invited to participate in 1-hour semi-structured interviews to discuss the results. In the EMR, 40 STOPP rules were successfully implemented. Phase 1: A total of 28 physicians from 8 practices were recruited (16 in intervention and 12 in control groups). The calculated PIP rate was 2.6% (138/5308) (control) and 4.11% (768/18,668) (intervention) at baseline. No change in PIPs was observed through the intervention (P=.80). Data quality probes generally showed low use of problem list and medication list. Phase 2: A total of 5 physicians participated. All the participants felt that they were aware of the alerts but commented on workflow and presentation challenges. The calculated PIP rate was markedly less than the expected rate found in literature (2.6% and 4.0% vs 20% in literature). Data quality probes highlighted issues related to completeness of data in areas of the EMR used for PIP reporting and by the decision support such as problem and medication lists. Users also highlighted areas for better integration of STOPP guidelines with

Quantum random number generator

Science.gov (United States)

Soubusta, Jan; Haderka, Ondrej; Hendrych, Martin

2001-03-01

Since reflection or transmission of a quantum particle on a beamsplitter is inherently random quantum process, a device built on this principle does not suffer from drawbacks of neither pseudo-random computer generators or classical noise sources. Nevertheless, a number of physical conditions necessary for high quality random numbers generation must be satisfied. Luckily, in quantum optics realization they can be well controlled. We present an easy random number generator based on the division of weak light pulses on a beamsplitter. The randomness of the generated bit stream is supported by passing the data through series of 15 statistical test. The device generates at a rate of 109.7 kbit/s.

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

What is covered by "cancer rehabilitation" in PubMed? A review of randomized controlled trials 1990-2011.

Science.gov (United States)

Gudbergsson, Sævar Berg; Dahl, Alv A; Loge, Jon Håvard; Thorsen, Lene; Oldervoll, Line M; Grov, Ellen K

2015-02-01

This focused review examines randomized controlled studies included by the term "cancer rehabilitation" in PubMed. The research questions concern the type of interventions performed and their methodological quality. Using the Medical Subject Headings (MeSH) terms: neoplasm AND rehabilitation, all articles with randomized controlled studies that included adult cancer patients, written in English, were extracted from PubMed. Papers covering physical exercise, psychiatric/psychological treatment or social support only were excluded as they had been reviewed recently. Abstracts and papers were assessed by 3 pairs of reviewers, and descriptive information was extracted systematically. Methodological quality was rated on a 10-item index scale, and the cut-off for acceptable quality was set at ≥ 8. A total of 132 (19%) of the 683 identified papers met the eligibility criteria and were assessed in detail. The papers were grouped into 5 thematic categories: 44 physical; 15 art and expressive; 47 psycho-educative; 21 emotionally supportive; and 5 others. Good quality of design was observed in 32 studies, 18 of them uni-dimensional and 14 multi-dimensional. Published randomized controlled studies on cancer rehabilitation are heterogeneous in terms of content and samples, and are mostly characterized by suboptimal design quality. Future studies should be more specific and well-designed with sufficient statistical strength.

Partner randomized controlled trial: study protocol and coaching intervention

Directory of Open Access Journals (Sweden)

Garbutt Jane M

2012-04-01

Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

Preference towards Control in Risk Taking: Control, No Control, or Randomize?

OpenAIRE

Li, King King

2010-01-01

This paper experimentally investigates preference towards different methods of control in risk taking. Participants are asked to choose between different ways for choosing which numbers to bet on for a gamble. They can choose the numbers themselves (control), let the experimenter choose (no control), or randomize. It is found that in addition to the more conventional preference for control, some participants prefer not to control, or randomization. These preferences are robust as participants...

Prospective, randomized, blinded evaluation of donor semen quality provided by seven commercial sperm banks.

Science.gov (United States)

Carrell, Douglas T; Cartmill, Deborah; Jones, Kirtly P; Hatasaka, Harry H; Peterson, C Matthew

2002-07-01

To evaluate variability in donor semen quality between seven commercial donor sperm banks, within sperm banks, and between intracervical insemination and intrauterine insemination. Prospective, randomized, blind evaluation of commercially available donor semen samples. An academic andrology laboratory. Seventy-five cryopreserved donor semen samples were evaluated. Samples were coded, then blindly evaluated for semen quality. Standard semen quality parameters, including concentration, motility parameters, World Health Organization criteria morphology, and strict criteria morphology. Significant differences were observed between donor semen banks for most semen quality parameters analyzed in intracervical insemination samples. In general, the greatest variability observed between banks was in percentage progressive sperm motility (range, 8.8 +/- 5.8 to 42.4 +/- 5.5) and normal sperm morphology (strict criteria; range, 10.1 +/- 3.3 to 26.6 +/- 4.7). Coefficients of variation within sperm banks were generally high. These data demonstrate the variability of donor semen quality provided by commercial sperm banks, both between banks and within a given bank. No relationship was observed between the size or type of sperm bank and the degree of variability. The data demonstrate the lack of uniformity in the criteria used to screen potential semen donors and emphasize the need for more stringent screening criteria and strict quality control in processing samples.

Implementing self sustained quality control procedures in a clinical laboratory.

Science.gov (United States)

Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

2013-01-01

Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.

Science.gov (United States)

Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

2018-04-01

Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children's heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28-82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). The recent literature in children's heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice.

Internet-Delivered Exposure Therapy for Fibromyalgia: A Randomized Controlled Trial.

Science.gov (United States)

Hedman-Lagerlöf, Maria; Hedman-Lagerlöf, Erik; Axelsson, Erland; Ljótsson, Brjánn; Engelbrektsson, Johanna; Hultkrantz, Sofia; Lundbäck, Karolina; Björkander, Daniel; Wicksell, Rikard K; Flink, Ida; Andersson, Erik

2018-06-01

Fibromyalgia (FM) is a common and disabling chronic pain disorder, for which existing pharmacological and psychological treatments have yet yielded insufficient effects. Previous literature has shown that exposure therapy may be an effective treatment for chronic pain. This study constitutes the first randomized controlled trial evaluating exposure therapy for FM. A total of 140 participants with diagnosed FM were randomized to a 10-week Internet-delivered exposure treatment (iExp; n=70) or a waitlist control condition (WLC; n=70). Primary outcome measure were FM symptoms and impact, and secondary outcome measures were fatigue, disability, quality of life, pain-related distress and avoidance behaviors, insomnia, depression, and anxiety. Data retention was high (100% data completion at posttreatment for primary outcome, 96% at 6-month follow-up and 94% at 12-month follow-up). Results showed that participants in the iExp group made large and superior improvements compared with WLC on FM symptoms and impact (B, -1.93; z, -10.14; P<0.001, between-group Cohen d=0.90), as well as all secondary outcomes (between-group Cohen d ranging from 0.44 to 1.38) with sustained results. We conclude that iExp seems to be an efficacious treatment for FM compared with no treatment, and the results also highlight the potential increase of accessibility by using the Internet format to deliver psychological treatments for these patients. Future trials with active control conditions are warranted.

Pilates Method for Women's Health: Systematic Review of Randomized Controlled Trials.

Science.gov (United States)

Mazzarino, Melissa; Kerr, Debra; Wajswelner, Henry; Morris, Meg E

2015-12-01

To critically analyze the benefits of Pilates on health outcomes in women. CINAHL, MEDLINE, PubMed, Science Direct, SPORTDiscus, Physiotherapy Evidence Database (PEDro), Cochrane Central Register of Controlled Trials, and Web of Science. Databases were searched using the terms Pilates and Pilates Method. Published randomized controlled trials (RCTs) were included if they comprised female participants with a health condition and a health outcome was measured, Pilates needed to be administered, and the article was published in English in a peer-reviewed journal from 1980 to July 2014. Two authors independently applied the inclusion criteria to potential studies. Methodological quality was assessed using the PEDro scale. A best-evidence grading system was used to determine the strength of the evidence. Thirteen studies met the inclusion criteria. PEDro scale values ranged from 3 to 7 (mean, 4.5; median, 4.0), indicating a relatively low quality overall. In this sample, Pilates for breast cancer was most often trialed (n=2). The most frequent health outcomes investigated were pain (n=4), quality of life (n=4), and lower extremity endurance (n=2), with mixed results. Emerging evidence was found for reducing pain and improving quality of life and lower extremity endurance. There is a paucity of evidence on Pilates for improving women's health during pregnancy or for conditions including breast cancer, obesity, or low back pain. Further high-quality RCTs are warranted to determine the effectiveness of Pilates for improving women's health outcomes. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Can Telemedicine Improve Adherence to Resuscitation Guidelines for Critically Ill Children at Community Hospitals? A Randomized Controlled Trial Using High-Fidelity Simulation.

Science.gov (United States)

Yang, Chris P; Hunt, Elizabeth A; Shilkofski, Nicole; Dudas, Robert; Egbuta, Chinyere; Schwartz, Jamie M

2017-07-01

Children transferred from community hospitals lacking specialized pediatric care are more seriously ill than those presenting to pediatric centers. Pediatric consultation and adherence to management guidelines improve outcomes. The aims of the study were (1) to assess whether telemedicine consultation in critical situations is feasible and (2) to compare the impact of pediatric critical care medicine (PCCM) consultation via telemedicine versus telephone on community hospital adherence to resuscitation guidelines through a randomized controlled telemedicine trial. In situ, high-fidelity simulation scenarios of critically ill children presenting to a community hospital and progressing to cardiopulmonary arrest were performed. Scenarios were randomized to PCCM consultation via telephone (control) or telemedicine (intervention). Primary outcome measure was proportion of teams who successfully defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia. The following 30 scenarios were completed: 15 control and 15 intervention. Only 11 (37%) of 30 teams, defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia; control: 6 (40%) of 15 versus intervention: 5 (33%) of 15, P = 0.7. Request for or use of backboard during cardiopulmonary resuscitation occurred in 24 (80%) of 30 scenarios; control: 9 (60%) of 15 versus intervention: 15 (100%) of 15, P = 0.006. Request for or use of stepstool during cardiopulmonary resuscitation occurred in 6 (20%) of 30 scenarios; control: 1 (7%) of 15 versus intervention: 5 (33%) of 15, P = 0.07. This study demonstrates the feasibility of using telemedicine to support acute management of children who present to community hospitals. Neither study arm adhered to current resuscitation guidelines and telemedicine consultation with PCCM experts was not associated with improvement. However, further research on optimizing telemedicine impact on the quality of pediatric care at

Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

Science.gov (United States)

Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

2014-04-01

This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

MALDI-TOF MS for quality control of high protein content sport supplements.

Science.gov (United States)

De Ceglie, Cristina; Calvano, Cosima D; Zambonin, Carlo G

2015-06-01

High protein content sport nutritional supplements are found as powder products containing, as ingredients, amino acids and proteins with important nutritional values as milk, soy and egg proteins. An EU Food Supplements Directive (2002) requires that supplements should be safe, both in dosages and in purity. It is important, then, to develop rapid and sensitive methods to be employed for the quality control of these substances. In this work, we apply, for the first time, matrix-assisted laser desorption ionization-mass spectrometry as a fast, reproducible and sensitive method for the quality control of sport nutritional supplements based on proteins. To this aim, several commercial egg- and/or milk-based powder products have been processed by in gel or in solution digestion and analyzed in comparison to pure standard products. This strategy allowed to assess the reliability of the indications on proteins (as caseins, whey proteins and ovalbumin) declared in the label of several sport nutritional supplements. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effect of chemotherapy counseling by pharmacists on quality of life and psychological outcomes of oncology patients in Malaysia: a randomized control trial.

Science.gov (United States)

Periasamy, Ummavathy; Mohd Sidik, Sherina; Rampal, Lekhraj; Fadhilah, Siti Irma; Akhtari-Zavare, Mehrnoosh; Mahmud, Rozi

2017-05-15

Cancer is now becoming a leading cause of death. Chemotherapy is an important treatment for cancer patients. These patients also need consultation during their treatment to improve quality of life and decrease psychological disorders. The objectives of the study were to develop, implement and evaluate the effectiveness of a chemotherapy counseling module by pharmacists among oncology patients on their quality of life and psychological outcomes in Malaysia. A single-blind randomized controlled trial was carried out among 162 oncology patients undergoing chemotherapy from July 2013 to February 2014 in a government hospital with oncology facilities in Malaysia. Participants were randomized to either the intervention group or the control group. Chemotherapy counseling using the module on 'Managing Patients on Chemotherapy' by Pharmacists was delivered to the intervention group. The outcome measures were assessed at baseline, first follow-up and second follow-up and third follow-up post-intervention. Chi-square, independent samples t-test and two-way repeated measures ANOVA were conducted in the course of the data analyses. In assessing the impact of the chemotherapy counseling module, the study revealed that the module along with repetitive counseling showed significant improvement of quality of life in the intervention group as compared to the control group with a large effect size in physical health (p = 0.001, partial Ƞ 2  = 0.66), psychological (p = 0.001, partial Ƞ 2  = 0.65), social relationships (p = 0.001, partial Ƞ 2  = 0.30), and environment (p = 0.001, partial Ƞ 2  = 0.67) and decrease in the anxiety (p = 0.000; partial Ƞ 2  = 0.23), depression (p = 0.000; partial Ƞ 2  = 0.40). The module on 'Managing Patients on Chemotherapy' along with repetitive counseling by pharmacists has been shown to be effective in improving quality of life and decreasing anxiety and depression among oncology patients undergoing chemotherapy

Controlled synthesis of high-quality crystals of monolayer MoS2 for nanoelectronic device application

DEFF Research Database (Denmark)

Yang, Xiaonian; Li, Qiang; Hu, Guofeng

2016-01-01

. Monolayer MoS2 so far can be obtained by mechanical exfoliation or chemical vapor deposition (CVD). However, controllable synthesis of large area monolayer MoS2 with high quality needs to be improved and their growth mechanism requires more studies. Here we report a systematical study on controlled...... synthesis of high-quality monolayer MoS2 single crystals using low pressure CVD. Large-size monolayer MoS2 triangles with an edge length up to 405 mu m were successfully synthesized. The Raman and photoluminescence spectroscopy studies indicate high homogenous optical characteristic of the synthesized...... monolayer MoS2 triangles. The transmission electron microscopy results demonstrate that monolayer MoS2 triangles are single crystals. The back-gated field effect transistors (FETs) fabricated using the as-grown monolayer MoS2 show typical n-type semiconductor behaviors with carrier mobility up to 21.8 cm(2...

Association between product quality control and process quality control of bulk milk

NARCIS (Netherlands)

Velthuis, A.; Asseldonk, van M.A.P.M.

2010-01-01

Assessment of dairy-milk quality is based on product quality control (testing bulk-milk samples) and process quality control (auditing dairy farms). It is unknown whether process control improves product quality. To quantify possible association between product control and process control a

Microcredit and willingness to pay for environmental quality: Evidence from a randomized-controlled trial of finance for sanitation in rural Cambodia.

Science.gov (United States)

Ben Yishay, Ariel; Fraker, Andrew; Guiteras, Raymond; Palloni, Giordano; Shah, Neil Buddy; Shirrell, Stuart; Wang, Paul

2017-11-01

Low willingness to pay (WTP) for environmental quality in developing countries is a key research question in environmental economics. One explanation is that missing credit markets may suppress WTP for environmental improvements that require large up-front investments. We test the impact of microloans on WTP for hygienic latrines via a randomized controlled trial in 30 villages in rural Cambodia. We find that microcredit dramatically raises WTP for improved latrines, with 60% of households in the Financing arm willing to purchase at an unsubsidized price, relative to 25% in the Non-financing arm. Effects on latrine installation are positive but muted by several factors, including a negative peer effect: randomly induced purchases by neighbors reduce a household's probability of installing its own latrine. On methodological grounds, this paper shows that a "decision-focused evaluation" can be integrated into academic analysis to provide insight into questions of general interest.

Meta-analysis of randomized controlled trials on cognitive effects of Bacopa monnieri extract.

Science.gov (United States)

Kongkeaw, Chuenjid; Dilokthornsakul, Piyameth; Thanarangsarit, Phurit; Limpeanchob, Nanteetip; Norman Scholfield, C

2014-01-01

Bacopa monnieri has a long history in Ayurvedic medicine for neurological and behavioral defects. To assess its efficacy in improving cognitive function. MEDLINE, EMBASE, CINAHL, AMED, Cochrane Central of clinical trial, WHO registry, Thai Medical Index, Index Medicus Siriraj library and www.clinicaltrial.gov were searched from the inception date of each database to June 2013 using scientific and common synonyms of Bacopa monnieri, cognitive performance or memory. The reference lists of retrieved articles were also reviewed. Randomized, placebo controlled human intervention trials on chronic ≥ 12 weeks dosing of standardized extracts of Bacopa monnieri without any co-medication were included in this study. The methodological quality of studies was assessed using Cochrane's risk of bias assessment and Jadad's quality scales. The weighted mean difference and 95% confidence interval (95% CI) were performed using the random-effects model of the Dersimonian-Laird method. Nine studies met the inclusion criteria using 518 subjects. Overall quality of all included trials was low risk of bias and quality of reported information was high. Meta-analysis of 437 eligible subjects showed improved cognition by shortened Trail B test (-17.9 ms; 95% CI -24.6 to -11.2; pBacopa monnieri has the potential to improve cognition, particularly speed of attention but only a large well designed 'head-to-head' trial against an existing medication will provide definitive data on its efficacy on healthy or dementia patients using a standardized preparation. © 2013 Elsevier Ireland Ltd. All rights reserved.

Chemotherapy-Related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients with, or without, High Protein Nutritional Support. A Prospective, Randomized Study.

Science.gov (United States)

Ziętarska, Monika; Krawczyk-Lipiec, Joanna; Kraj, Leszek; Zaucha, Renata; Małgorzewicz, Sylwia

2017-10-11

Cancer disease is usually associated with impaired nutritional status, which is one of the factors contributing to deterioration of the results of surgery, chemotherapy or radiotherapy. The aim of the study was to determine whether nutritional support with high protein (ONS) in adult oncologic patients in the first step of cancer cachexia-asymptomatic precachexia, has an influence on the toxicity of systemic therapy. However, secondary endpoints were established: to determine whether high protein ONS influences the nutritional status, the quality of life, and the performance status. A total of 114 persons aged 40-84 years old with colorectal cancer were examined. Based on the randomization, 47 patients were qualified to the interventional group (ONS group) and 48 to Control group. To evaluate the nutritional status NRS-2002 (Nutritional Risk Screening), SGA (Subjective Global Assessment), SCRINIO (SCReenIng the Nutritional status In Oncology) Working Group classification, VAS (Visual Analog Scale) for appetite was used. FAACT (Functional Assessment of Anorexia/Cachexia Therapy) questionnaire was used for assessment of the quality of life. The health status of patients was evaluated based on the Karnofsky Performance Scale. Anthropometric measurements were done. Severe complications of chemotherapy, which caused the end of treatment, a slight complication of the gastrointestinal tract such as diarrhea grade 2 according to ECOG (Eastern Cooperative Oncology Group) score regardless of the studied group, were observed. There were no statistical differences in the number and severity of the observed complications, i.e., neutropenia, leucopenia, thrombocytopenia, anemia, abdominal pain, nausea and vomiting, and diarrhea. During the follow-up the significant changes of SGA, VAS, albumin and prealbumin were observed between groups. In the ONS group an improvement in nutritional status was noticed (increased appetite VAS, p = 0.05; increased points in SGA, p = 0.015, and

Effects of Mat Pilates on Physical Functional Performance of Older Adults: A Meta-analysis of Randomized Controlled Trials.

Science.gov (United States)

Bueno de Souza, Roberta Oliveira; Marcon, Liliane de Faria; Arruda, Alex Sandro Faria de; Pontes Junior, Francisco Luciano; Melo, Ruth Caldeira de

2018-06-01

The present meta-analysis aimed to examine evidence from randomized controlled trials to determine the effects of mat Pilates on measures of physical functional performance in the older population. A search was conducted in the MEDLINE/PubMed, Scopus, Scielo, and PEDro databases between February and March 2017. Only randomized controlled trials that were written in English, included subjects aged 60 yrs who used mat Pilates exercises, included a comparison (control) group, and reported performance-based measures of physical function (balance, flexibility, muscle strength, and cardiorespiratory fitness) were included. The methodological quality of the studies was analyzed according to the PEDro scale and the best-evidence synthesis. The meta-analysis was conducted with the Review Manager 5.3 software. The search retrieved 518 articles, nine of which fulfilled the inclusion criteria. High methodological quality was found in five of these studies. Meta-analysis indicated a large effect of mat Pilates on dynamic balance (standardized mean difference = 1.10, 95% confidence interval = 0.29-1.90), muscle strength (standardized mean difference = 1.13, 95% confidence interval = 0.30-1.96), flexibility (standardized mean difference = 1.22, 95% confidence interval = 0.39-2.04), and cardiorespiratory fitness (standardized mean difference = 1.48, 95% confidence interval = 0.42-2.54) of elderly subjects. There is evidence that mat Pilates improves dynamic balance, lower limb strength, hip and lower back flexibility, and cardiovascular endurance in elderly individuals. Furthermore, high-quality studies are necessary to clarify the effects of mat Pilates on other physical functional measurements among older adults.

A Randomized Control Trial of Cardiopulmonary Feedback Devices and Their Impact on Infant Chest Compression Quality: A Simulation Study.

Science.gov (United States)

Austin, Andrea L; Spalding, Carmen N; Landa, Katrina N; Myer, Brian R; Donald, Cure; Smith, Jason E; Platt, Gerald; King, Heather C

2017-10-27

In effort to improve chest compression quality among health care providers, numerous feedback devices have been developed. Few studies, however, have focused on the use of cardiopulmonary resuscitation feedback devices for infants and children. This study evaluated the quality of chest compressions with standard team-leader coaching, a metronome (MetroTimer by ONYX Apps), and visual feedback (SkillGuide Cardiopulmonary Feedback Device) during simulated infant cardiopulmonary resuscitation. Seventy voluntary health care providers who had recently completed Pediatric Advanced Life Support or Basic Life Support courses were randomized to perform simulated infant cardiopulmonary resuscitation into 1 of 3 groups: team-leader coaching alone (control), coaching plus metronome, or coaching plus SkillGuide for 2 minutes continuously. Rate, depth, and frequency of complete recoil during cardiopulmonary resuscitation were recorded by the Laerdal SimPad device for each participant. American Heart Association-approved compression techniques were randomized to either 2-finger or encircling thumbs. The metronome was associated with more ideal compression rate than visual feedback or coaching alone (104/min vs 112/min and 113/min; P = 0.003, 0.019). Visual feedback was associated with more ideal depth than auditory (41 mm vs 38.9; P = 0.03). There were no significant differences in complete recoil between groups. Secondary outcomes of compression technique revealed a difference of 1 mm. Subgroup analysis of male versus female showed no difference in mean number of compressions (221.76 vs 219.79; P = 0.72), mean compression depth (40.47 vs 39.25; P = 0.09), or rate of complete release (70.27% vs 64.96%; P = 0.54). In the adult literature, feedback devices often show an increase in quality of chest compressions. Although more studies are needed, this study did not demonstrate a clinically significant improvement in chest compressions with the addition of a metronome or visual

Randomized controlled trial on the effects of a combined sleep hygiene education and behavioral approach program on sleep quality in workers with insomnia.

Science.gov (United States)

Kaku, Akiko; Nishinoue, Nao; Takano, Tomoki; Eto, Risa; Kato, Noritada; Ono, Yutaka; Tanaka, Katsutoshi

2012-01-01

To evaluate the effects of a combined sleep hygiene education and behavioral approach program on sleep quality in workers with insomnia, we conducted a randomized controlled trial at a design engineering unit in Japan. Employees evaluated for insomnia by the Athens Insomnia Scale (≥6 points) were divided into an intervention and control group. The intervention group received a short-term intervention (30 min) program that included sleep hygiene education and behavioral approaches (relaxation training, stimulus control, and sleep restriction) performed by occupational health professionals. We calculated differences in change in Pittsburgh Sleep Quality Index (PSQI) scores between the two groups from baseline to three months after the start of intervention after adjusting for gender, age, job title, job category, average number of hours of overtime during the study period, marital status, smoking habit, average number of days of alcohol consumption per week, exercise habits, K6 score, and baseline PSQI score. Results showed that the average PSQI score decreased by 1.0 in the intervention group but increased by 0.9 in the control group. Additionally, the difference in variation between the two groups was 1.9 (95% confidence interval: 0.6 to 3.4), which was significant. Taken together, these results indicate that the intervention program significantly improved the sleep quality of workers with insomnia.

Quality Control Applications

CERN Document Server

Chorafas, Dimitris N

2013-01-01

Quality control is a constant priority in electrical, mechanical, aeronautical, and nuclear engineering – as well as in the vast domain of electronics, from home appliances to computers and telecommunications. Quality Control Applications provides guidance and valuable insight into quality control policies; their methods, their implementation, constant observation and associated technical audits. What has previously been a mostly mathematical topic is translated here for engineers concerned with the practical implementation of quality control. Once the fundamentals of quality control are established, Quality Control Applications goes on to develop this knowledge and explain how to apply it in the most effective way. Techniques are described and supported using relevant, real-life, case studies to provide detail and clarity for those without a mathematical background. Among the many practical examples, two case studies dramatize the importance of quality assurance: A shot-by-shot analysis of the errors made ...

MATIN: a random network coding based framework for high quality peer-to-peer live video streaming.

Science.gov (United States)

Barekatain, Behrang; Khezrimotlagh, Dariush; Aizaini Maarof, Mohd; Ghaeini, Hamid Reza; Salleh, Shaharuddin; Quintana, Alfonso Ariza; Akbari, Behzad; Cabrera, Alicia Triviño

2013-01-01

In recent years, Random Network Coding (RNC) has emerged as a promising solution for efficient Peer-to-Peer (P2P) video multicasting over the Internet. This probably refers to this fact that RNC noticeably increases the error resiliency and throughput of the network. However, high transmission overhead arising from sending large coefficients vector as header has been the most important challenge of the RNC. Moreover, due to employing the Gauss-Jordan elimination method, considerable computational complexity can be imposed on peers in decoding the encoded blocks and checking linear dependency among the coefficients vectors. In order to address these challenges, this study introduces MATIN which is a random network coding based framework for efficient P2P video streaming. The MATIN includes a novel coefficients matrix generation method so that there is no linear dependency in the generated coefficients matrix. Using the proposed framework, each peer encapsulates one instead of n coefficients entries into the generated encoded packet which results in very low transmission overhead. It is also possible to obtain the inverted coefficients matrix using a bit number of simple arithmetic operations. In this regard, peers sustain very low computational complexities. As a result, the MATIN permits random network coding to be more efficient in P2P video streaming systems. The results obtained from simulation using OMNET++ show that it substantially outperforms the RNC which uses the Gauss-Jordan elimination method by providing better video quality on peers in terms of the four important performance metrics including video distortion, dependency distortion, End-to-End delay and Initial Startup delay.

A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

DEFF Research Database (Denmark)

Miller, I; Lynggaard, C D; Lophaven, S

2011-01-01

BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo-controlled,......BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo......-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg...... subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing...

Effects of shared medical appointments on quality of life and cost-effectiveness for patients with a chronic neuromuscular disease. Study protocol of a randomized controlled trial

Directory of Open Access Journals (Sweden)

van der Wilt Gert-Jan

2011-08-01

Full Text Available Abstract Background Shared medical appointments are a series of one-to-one doctor-patient contacts, in presence of a group of 6-10 fellow patients. This group visits substitute the annual control visits of patients with the neurologist. The same items attended to in a one-to- one appointment are addressed. The possible advantages of a shared medical appointment could be an added value to the present management of neuromuscular patients. The currently problem-focused one-to-one out-patient visits often leave little time for the patient's psychosocial needs, patient education, and patient empowerment. Methods/design A randomized, prospective controlled study (RCT with a follow up of 6 months will be conducted to evaluate the clinical and cost-effectiveness of shared medical appointments compared to usual care for 300 neuromuscular patients and their partners at the Radboud University Nijmegen Medical Center. Every included patient will be randomly allocated to one of the two study arms. This study has been reviewed and approved by the medical ethics committee of the region Arnhem-Nijmegen, the Netherlands. The primary outcome measure is quality of life as measured by the EQ-5D, SF-36 and the Individualized neuromuscular Quality of Life Questionnaire. The primary analysis will be an intention-to-treat analysis on the area under the curve of the quality of life scores. A linear mixed model will be used with random factor group and fixed factors treatment, baseline score and type of neuromuscular disease. For the economic evaluation an incremental cost-effectiveness analysis will be conducted from a societal perspective, relating differences in costs to difference in health outcome. Results are expected in 2012. Discussion This study will be the first randomized controlled trial which evaluates the effect of shared medical appointments versus usual care for neuromuscular patients. This will enable to determine if there is additional value of shared

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.

Problem-Solving Therapy During Outpatient Stroke Rehabilitation Improves Coping and Health-Related Quality of Life: Randomized Controlled Trial.

Science.gov (United States)

Visser, Marieke M; Heijenbrok-Kal, Majanka H; Van't Spijker, Adriaan; Lannoo, Engelien; Busschbach, Jan J V; Ribbers, Gerard M

2016-01-01

This study investigated whether problem-solving therapy (PST) is an effective group intervention for improving coping strategy and health-related quality of life (HRQoL) in patients with stroke. In this multicenter randomized controlled trial, the intervention group received PST as add-on to standard outpatient rehabilitation, the control group received outpatient rehabilitation only. Measurements were performed at baseline, directly after the intervention, and 6 and 12 months later. Data were analyzed using linear-mixed models. Primary outcomes were task-oriented coping as measured by the Coping Inventory for Stressful Situations and psychosocial HRQoL as measured by the Stroke-Specific Quality of Life Scale. Secondary outcomes were the EuroQol EQ-5D-5L utility score, emotion-oriented and avoidant coping as measured by the Coping Inventory for Stressful Situations, problem-solving skills as measured by the Social Problem Solving Inventory-Revised, and depression as measured by the Center for Epidemiological Studies Depression Scale. Included were 166 patients with stroke, mean age 53.06 years (SD, 10.19), 53% men, median time poststroke 7.29 months (interquartile range, 4.90-10.61 months). Six months post intervention, the PST group showed significant improvement when compared with the control group in task-oriented coping (P=0.008), but not stroke-specific psychosocial HRQoL. Furthermore, avoidant coping (P=0.039) and the utility value for general HRQoL (P=0.034) improved more in the PST group than in the control after 6 months. PST seems to improve task-oriented coping but not disease-specific psychosocial HRQoL after stroke >6-month follow-up. Furthermore, we found indications that PST may improve generic HRQoL recovery and avoidant coping. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2509. Unique identifier: CNTR2509. © 2015 American Heart Association, Inc.

Parallel Monte Carlo Particle Transport and the Quality of Random Number Generators: How Good is Good Enough?

International Nuclear Information System (INIS)

Procassini, R J; Beck, B R

2004-01-01

It might be assumed that use of a ''high-quality'' random number generator (RNG), producing a sequence of ''pseudo random'' numbers with a ''long'' repetition period, is crucial for producing unbiased results in Monte Carlo particle transport simulations. While several theoretical and empirical tests have been devised to check the quality (randomness and period) of an RNG, for many applications it is not clear what level of RNG quality is required to produce unbiased results. This paper explores the issue of RNG quality in the context of parallel, Monte Carlo transport simulations in order to determine how ''good'' is ''good enough''. This study employs the MERCURY Monte Carlo code, which incorporates the CNPRNG library for the generation of pseudo-random numbers via linear congruential generator (LCG) algorithms. The paper outlines the usage of random numbers during parallel MERCURY simulations, and then describes the source and criticality transport simulations which comprise the empirical basis of this study. A series of calculations for each test problem in which the quality of the RNG (period of the LCG) is varied provides the empirical basis for determining the minimum repetition period which may be employed without producing a bias in the mean integrated results

Effects of active/passive interventions on pain, anxiety, and quality of life in women with fibromyalgia: Randomized controlled pilot trial.

Science.gov (United States)

Ekici, Gamze; Unal, Edibe; Akbayrak, Turkan; Vardar-Yagli, Naciye; Yakut, Yavuz; Karabulut, Erdem

2017-01-01

The authors of this study compared the effects of pilates exercises and connective tissue massage (CTM) on pain intensity; pain-pressure threshold; and tolerance, anxiety, progress, and health-related quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August of 2013. Twenty-one women with fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a 4-week period. The Visual Analogue Scale, algometry, State-Trait Anxiety Inventory, Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of treatments. Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than the massage group and thus might be preferred for patients with fibromyalgia. However, an adequately powered trial is required to determine this with certainty.

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

Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial

Science.gov (United States)

Khan, Sameer; Rogers, Jason D; Otobo, Emamuzo; Patel, Nishant P; Ullman, Thomas; Colombel, Jean Fred; Moore, Shirley; Sands, Bruce E

2015-01-01

Background Inflammatory bowel disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients ideal candidates for patient-engaged care that is centered on enhanced self-management and improved doctor-patient communication. In IBD, optimal approaches to management vary for patients with different phenotypes and extent of disease and past surgical history. Hence, a single quality metric cannot define a heterogeneous disease such as IBD, unlike hypertension and diabetes. A more comprehensive assessment may be provided by complementing traditional quality metrics with measures of the patient’s quality of life (QOL) through an application like HealthPROMISE. Objective The objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes (quality of care [QOC], QOL, patient adherence, disease control, and resource utilization) as compared to a patient education app. Our hypothesis is that a patient-centric self-monitoring and collaborative decision support platform will lead to sustainable improvement in overall QOL for IBD patients. Methods Participants will be recruited during face-to-face visits and randomized to either an interventional (ie, HealthPROMISE) or control (ie, education app). Patients in the HealthPROMISE arm will be able to update their information and receive disease summary, quality metrics, and a graph showing the trend of QOL (SIBDQ) scores and resource utilization over time. Providers will use the data for collaborative decision making and quality improvement interventions at the point of care. Patients in the control arm will enter data at baseline, during office visits, and at the end of the study but will not receive any decision support (trend of QOL, alert, or dashboard views). Results Enrollment in the trial will be starting in first quarter of 2015. It is intended that up to 300

Bone marrow stromal cell therapy for ischemic stroke: A meta-analysis of randomized control animal trials.

Science.gov (United States)

Wu, Qing; Wang, Yuexiang; Demaerschalk, Bart M; Ghimire, Saruna; Wellik, Kay E; Qu, Wenchun

2017-04-01

Background Results of animal studies assessing efficacy of bone marrow stromal cell therapy for ischemic stroke remain inconsistent. Aims The aims are to assess efficacy of bone marrow stromal cell therapy for ischemic stroke in animal studies. Methods Randomized controlled animal trials assessing efficacy of bone marrow stromal cell therapy were eligible. Stroke therapy academic industry round table was used to assess methodologic quality of included studies. Primary outcomes were total infarction volume and modified Neurological Severity Score. Multiple prespecified sensitivity analyses and subgroup analyses were conducted. Random effects models were used for meta-analysis. Results Thirty-three randomized animal trials were included with a total of 796 animals. The median quality score was 6 (interquartile range, 5-7). Bone marrow stromal cell therapy decreased total infarction volume (standardized mean difference, 0.897; 95% confidence interval, 0.553-1.241; P animals treated with bone marrow stromal cell and controls was 2.47 (95% confidence interval, 1.84-3.11; P animal studies. Conclusions Bone marrow stromal cell therapy significantly decreased total infarction volume and increased neural functional recovery in randomized controlled animal models of ischemic stroke.

Randomized controlled trials and neuro-oncology: should alternative designs be considered?

Science.gov (United States)

Mansouri, Alireza; Shin, Samuel; Cooper, Benjamin; Srivastava, Archita; Bhandari, Mohit; Kondziolka, Douglas

2015-09-01

Deficiencies in design and reporting of randomized controlled trials (RCTs) hinders interpretability and critical appraisal. The reporting quality of recent RCTs in neuro-oncology was analyzed to assess adequacy of design and reporting. The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2005-2014, inclusive). The CONSORT and Jadad scales were used to assess the quality of design/reporting. Studies published in 2005-2010 were compared as a cohort against studies published in 2011-2014, in terms of general characteristics and reporting quality. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman's test was used to assess correlations. Regression analysis was used to assess associations. Overall 68 RCTs were identified. Studies were often chemotherapy-based (n = 41 studies) focusing upon high grade gliomas (46 %) and metastases (41 %) as the top pathologies. Multi-center trials (71 %) were frequent. The overall median CONSORT and Jadad scores were 34.5 (maximum 44) and 2 (maximum 5), respectively; these scores were similar in radiation and chemotherapy-based trials. Major areas of deficiency pertained to allocation concealment, implementation of methods, and blinding whereby less than 20 % of articles fulfilled all criteria. Description of intervention, random sequence generation, and the details regarding recruitment were also deficient; less than 50 % of studies fulfilled all criteria. Description of sample size calculations and blinding improved in later published cohorts. Journal impact factor was significantly associated with higher quality (p = 0.04). Large academic consortia, multi-center designs, ITT analysis, collaboration with biostatisticians, larger sample sizes, and studies with pragmatic objectives were more likely to achieve positive primary outcomes on univariate analysis; none of these variables were significant on multivariate analysis. Deficiencies in the

Quality pseudo-random number generator

International Nuclear Information System (INIS)

Tarasiuk, J.

1996-01-01

The pseudo-random number generator (RNG) was written to match needs of nuclear and high-energy physics computation which in some cases require very long and independent random number sequences. In this random number generator the repetition period is about 10 36 what should be sufficient for all computers in the world. In this article the test results of RNG correlation, speed and identity of computations for PC, Sun4 and VAX computer tests are presented

Effect of a high-intensity exercise program on physical function and mental health in nursing home residents with dementia: an assessor blinded randomized controlled trial.

Directory of Open Access Journals (Sweden)

Elisabeth Wiken Telenius

Full Text Available Dementia is among the leading causes of functional loss and disability in older adults. Research has demonstrated that nursing home patients without dementia can improve their function in activities of daily living, strength, balance and mental well being by physical exercise. The evidence on effect of physical exercise among nursing home patients with dementia is scarce and ambiguous. Thus, the primary objective of this study was to investigate the effect of a high intensity functional exercise program on the performance of balance in nursing home residents with dementia. The secondary objective was to examine the effect of this exercise on muscle strength, mobility, activities of daily living, quality of life and neuropsychiatric symptoms.This single blinded randomized controlled trial was conducted among 170 persons with dementia living in nursing homes. Mean age was 86.7 years (SD = 7.4 and 74% were women. The participants were randomly allocated to an intervention (n = 87 or a control group (n = 83. The intervention consisted of intensive strengthening and balance exercises in small groups twice a week for 12 weeks. The control condition was leisure activities.The intervention group improved the score on Bergs Balance Scale by 2.9 points, which was significantly more than the control group who improved by 1.2 points (p = 0.02. Having exercised 12 times or more was significantly associated with improved strength after intervention (p<0.05. The level of apathy was lower in the exercise group after the intervention, compared to the control group (p = 0.048.The results from our study indicate that a high intensity functional exercise program improved balance and muscle strength as well as reduced apathy in nursing home patients with dementia.ClinicalTrials.gov NCT02262104.

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.

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.

Randomized controlled trials in children’s heart surgery in the 21st century: a systematic review

Science.gov (United States)

Drury, Nigel E; Patel, Akshay J; Oswald, Nicola K; Chong, Cher-Rin; Stickley, John; Barron, David J; Jones, Timothy J

2018-01-01

Abstract OBJECTIVES Randomized controlled trials are the gold standard for evaluating health care interventions, yet are uncommon in children’s heart surgery. We conducted a systematic review of clinical trials in paediatric cardiac surgery to evaluate the scope and quality of the current international literature. METHODS We searched MEDLINE, CENTRAL and LILACS, and manually screened retrieved references and systematic reviews to identify all randomized controlled trials reporting the effect of any intervention on the conduct or outcomes of heart surgery in children published in any language since January 2000; secondary publications and those reporting inseparable adult data were excluded. Two reviewers independently screened studies for eligibility and extracted data; the Cochrane Risk of Bias tool was used to assess for potential biases. RESULTS We identified 333 trials from 34 countries randomizing 23 902 children. Most were early phase (313, 94.0%), recruiting few patients (median 45, interquartile range 28–82), and only 11 (3.3%) directly evaluated a surgical intervention. One hundred and nine (32.7%) trials calculated a sample size, 52 (15.6%) reported a CONSORT diagram, 51 (15.3%) were publicly registered and 25 (7.5%) had a Data Monitoring Committee. The overall risk of bias was low in 22 (6.6%), high in 69 (20.7%) and unclear in 242 (72.7%). CONCLUSIONS The recent literature in children’s heart surgery contains few late-phase clinical trials. Most trials did not conform to the accepted standards of reporting, and the overall risk of bias was low in few studies. There is a need for high-quality, multicentre clinical trials to provide a robust evidence base for contemporary paediatric cardiac surgical practice. PMID:29186478

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.

Controller adherence following hospital discharge in high risk children: A pilot randomized trial of text message reminders.

Science.gov (United States)

Kenyon, Chén C; Gruschow, Siobhan M; Quarshie, William O; Griffis, Heather; Leach, Michelle C; Zorc, Joseph J; Bryant-Stephens, Tyra C; Miller, Victoria A; Feudtner, Chris

2018-02-13

To assess the feasibility of a mobile health, inhaled corticosteroid (ICS) adherence reminder intervention and to characterize adherence trajectories immediately following severe asthma exacerbation in high-risk urban children with persistent asthma. Children aged 2-13 with persistent asthma were enrolled in this pilot randomized controlled trial during an asthma emergency department (ED) visit or hospitalization. Intervention arm participants received daily text message reminders for 30 days, and both arms received electronic sensors to measure ICS use. Primary outcomes were feasibility of sensor use and text message acceptability. Secondary outcomes included adherence to prescribed ICS regimen and 30-day adherence trajectories. Group-based trajectory modeling was used to examine adherence trajectories. Forty-one participants (mean age 5.9) were randomized to intervention (n = 21) or control (n = 20). Overall, 85% were Black, 88% had public insurance, and 51% of the caregivers had a high school education or less. Thirty-two participant families (78%) transmitted medication adherence data; of caregivers who completed the acceptability survey, 25 (96%) chose to receive daily reminders beyond that study interval. Secondary outcome analyses demonstrated similar average daily adherence between groups (intervention = 36%; control = 32%, P = 0.73). Three adherence trajectories were identified with none ever exceeding 80% adherence. Within a high-risk pediatric cohort, electronic monitoring of ICS use and adherence reminders delivered via text message were feasible for most participants, but there was no signal of effect. Adherence trajectories following severe exacerbation were suboptimal, demonstrating an important opportunity for asthma care improvement.

Acupuncture and physical exercise for affective symptoms and health-related quality of life in polycystic ovary syndrome: secondary analysis from a randomized controlled trial

OpenAIRE

Stener-Victorin, Elisabet; Holm, G?ran; Janson, Per Olof; Gustafson, Deborah; Waern, Margda

2013-01-01

Background Women with polycystic ovary syndrome (PCOS) have symptoms of depression and anxiety and impaired health related quality of life (HRQoL). Here we test the post-hoc hypothesis that acupuncture and exercise improve depression and anxiety symptoms and HRQoL in PCOS women. Methods Seventy-two PCOS women were randomly assigned to 16?weeks of 1) acupuncture (n?=?28); 2) exercise (n?=?29); or 3) no intervention (control) (n?=?15). Outcome measures included: change in Montgomery ?sberg Depr...

The effect of empowerment on the self-efficacy, quality of life and clinical and laboratory indicators of patients treated with hemodialysis: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Moattari Marzieh

2012-09-01

Full Text Available Abstract Background Hemodialysis patients face numerous physical and psychological stresses that result in reduced health. The aim of this study is to determine the impact of an empowerment program on self-efficacy, quality of life, clinical indicators of blood pressure and interdialytic weight gain, and laboratory results in these patients. Methods This randomized, controlled trial was conducted at Boo Ali Sina Dialysis Center, Shiraz, Iran. A total of 48 hemodialysis patients participated in this study. After acquisition of informed consent, eligible patients were randomly divided into two groups, control and experimental. Pre-test data were obtained by using a demographic data form and two questionnaires for self-efficacy and quality of life. Blood pressure and interdialytic weight gain were measured. We extracted laboratory data from patients’ charts. A six-week empowerment intervention that included four individual and two group counselling sessions was performed for the experimental group. Six weeks after intervention, post-test data were obtained from both groups in the same manner as the pre-test. Data were analyzed by ANCOVA using SPSS v11.5. Results There were no statistically significant differences in demographic variables between the groups. Pre-test mean scores for self-efficacy, quality of life, blood pressure, interdialytic weight gain and laboratory results did not differ between the groups. There was a significant difference between the experimental and control groups in terms of pre-to post-intervention changes in overall self-efficacy scores, stress reduction, and decision making, in addition to overall quality of life and all dimensions included within quality of life based on this questionnaire. Additionally, the pre- to post-intervention changes in systolic/diastolic blood pressures, interdialytic weight gain, hemoglobin and hematocrit levels significantly differed between the groups. Conclusion Our study demonstrates

Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong.

Science.gov (United States)

Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

2016-07-29

Most positive psychology interventions conducted in the West have been focused on the individual. Family relationships are highly valued in the Chinese collectivist culture, and it is of interest to know whether family-focused interventions can improve the well-being of Chinese people. We have previously reported the effectiveness of a positive psychology family intervention in terms of family well-being. Based on the data derived from the Happy Family Kitchen II project, this paper examines the effectiveness of a community-based positive psychology family intervention on subjective happiness and health-related quality of life. Thirty-one social service units and schools organized intervention programs for 2070 participants in Hong Kong. In a cluster randomized controlled trial, participants were randomly assigned on the basis of computer-generated numbers into the intervention group or the control group. The intervention programs emphasized one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. The control group engaged in activities unrelated to the intervention, such as arts and crafts workshops. Subjective happiness and mental and physical quality of life were assessed at baseline and at 4 weeks and 12 weeks postintervention. Data of 1261 participants were analyzed. The results showed that the intervention was more effective than the control condition in improving subjective happiness, with a small effect size, at 12 weeks postintervention (β = .15, p = .020, Cohen's d = .16). However, there were no improvements in mental and physical quality of life in the intervention group compared with the control group at 4 weeks (β = .39, p = .494, d = .05; β = -.10, p = 1.000, d = -.01, respectively) and 12 weeks postintervention (β = .71, p = .233, d = .08; β = -.05, p = 1.000, d = -.01, respectively). Furthermore, the booster session was no more effective than the tea

Impact of Pelvic Floor Physical Therapy on Quality of Life and Function After Obstetric Anal Sphincter Injury: A Randomized Controlled Trial.

Science.gov (United States)

Oakley, Susan H; Ghodsi, Vivian C; Crisp, Catrina C; Estanol, Maria Victoria; Westermann, Lauren B; Novicki, Kathleen M; Kleeman, Steven D; Pauls, Rachel N

2016-01-01

There is no standard of care for women sustaining an obstetric anal sphincter injury (OASIS). We sought to determine whether pelvic floor physical therapy (PFPT) would improve the quality of life and function in women 12 weeks after OASIS. This institutional review board-approved randomized trial enrolled primiparous women 2 weeks after delivery complicated by OASIS. After informed consent, all subjects underwent vaginal electromyography and anorectal manometry and completed validated questionnaires; measures were repeated for all subjects at 12 weeks after delivery. The intervention arm completed 4 PFPT sessions. The primary outcome was a change in the Fecal Incontinence Quality of Life. Three hundred four women were screened; 250 were excluded, and 54 were randomized. After four were lost to follow-up, analysis included 27 in the intervention arm and 23 in the control arm. Overall, mean age was 29.8 ± 4.7 years, and there were no demographic differences between groups.Fecal Incontinence Quality of Life domain scores showed improvement for both groups from baseline to 12 weeks for coping (P = 0.006) and depression (P = 0.009); however, there was no difference in domain scores between groups. For the secondary outcome of anorectal manometry, squeezing pressure improved for all subjects (P = 0.035) from baseline to 12 weeks. Vaginal EMG strength (microvolts) increased for all subjects in measures of rest average (P < 0.000), rapid peak (P = 0.006), and work average (P < 0.000), with no difference based on therapeutic arm. All women showed improvements in quality of life and function at 12 weeks after delivery, regardless of treatment allocation. Further study is needed to determine whether PFPT provides a significant benefit to women having OASIS.

Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: A Randomized Controlled Trial.

Science.gov (United States)

Meissner, Karin; Schweizer-Arau, Annemarie; Limmer, Anna; Preibisch, Christine; Popovici, Roxana M; Lange, Isabel; de Oriol, Barbara; Beissner, Florian

2016-11-01

To evaluate whether psychotherapy with somatosensory stimulation is effective for the treatment of pain and quality of life in patients with endometriosis-related pain. Patients with a history of endometriosis and chronic pelvic pain were randomized to either psychotherapy with somatosensory stimulation (ie, different techniques of acupuncture point stimulation) or wait-list control for 3 months, after which all patients were treated. The primary outcome was brain connectivity assessed by functional magnetic resonance imaging. Prespecified secondary outcomes included pain on 11-point numeric rating scales (maximal and average global pain, pelvic pain, dyschezia, and dyspareunia) and physical and mental quality of life. A sample size of 30 per group was planned to compare outcomes in the treatment group and the wait-list control group. From March 2010 through March 2012, 67 women (mean age 35.6 years) were randomly allocated to intervention (n=35) or wait-list control (n=32). In comparison with wait-list controls, treated patients showed improvements after 3 months in maximal global pain (mean group difference -2.1, 95% confidence interval [CI] -3.4 to -0.8; P=.002), average global pain (-2.5, 95% CI -3.5 to -1.4; P<.001), pelvic pain (-1.4, 95% CI -2.7 to -0.1; P=.036), dyschezia (-3.5, 95% CI -5.8 to -1.3; P=.003), physical quality of life (3.8, 95% CI 0.5-7.1, P=.026), and mental quality of life (5.9, 95% CI 0.6-11.3; P=.031); dyspareunia improved nonsignificantly (-1.8, 95% CI -4.4 to 0.7; P=.150). Improvements in the intervention group remained stable at 6 and 24 months, and control patients showed comparable symptom relief after delayed intervention. Psychotherapy with somatosensory stimulation reduced global pain, pelvic pain, and dyschezia and improved quality of life in patients with endometriosis. After 6 and 24 months, when all patients were treated, both groups showed stable improvements. ClinicalTrials.gov, https://clinicaltrials.gov, NCT01321840.

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

A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

Science.gov (United States)

Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

2014-09-01

To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

MATIN: a random network coding based framework for high quality peer-to-peer live video streaming.

Directory of Open Access Journals (Sweden)

Behrang Barekatain

Full Text Available In recent years, Random Network Coding (RNC has emerged as a promising solution for efficient Peer-to-Peer (P2P video multicasting over the Internet. This probably refers to this fact that RNC noticeably increases the error resiliency and throughput of the network. However, high transmission overhead arising from sending large coefficients vector as header has been the most important challenge of the RNC. Moreover, due to employing the Gauss-Jordan elimination method, considerable computational complexity can be imposed on peers in decoding the encoded blocks and checking linear dependency among the coefficients vectors. In order to address these challenges, this study introduces MATIN which is a random network coding based framework for efficient P2P video streaming. The MATIN includes a novel coefficients matrix generation method so that there is no linear dependency in the generated coefficients matrix. Using the proposed framework, each peer encapsulates one instead of n coefficients entries into the generated encoded packet which results in very low transmission overhead. It is also possible to obtain the inverted coefficients matrix using a bit number of simple arithmetic operations. In this regard, peers sustain very low computational complexities. As a result, the MATIN permits random network coding to be more efficient in P2P video streaming systems. The results obtained from simulation using OMNET++ show that it substantially outperforms the RNC which uses the Gauss-Jordan elimination method by providing better video quality on peers in terms of the four important performance metrics including video distortion, dependency distortion, End-to-End delay and Initial Startup delay.

The impact of a family skills training intervention among Burmese migrant families in Thailand: A randomized controlled trial.

Science.gov (United States)

Puffer, Eve S; Annan, Jeannie; Sim, Amanda L; Salhi, Carmel; Betancourt, Theresa S

2017-01-01

To conduct a randomized controlled trial assessing the impact of a family-based intervention delivered to Burmese migrant families displaced in Thailand on parenting and family functioning. Participants included 479 Burmese migrant families from 20 communities in Thailand. Families, including 513 caregivers and 479 children aged 7 to 15 years, were randomized to treatment and waitlist control groups. The treatment group received a 12-session family-based intervention delivered to groups of families by lay facilitators. Adapted standardized and locally derived measures were administered before and after the intervention to assess parent-child relationship quality, discipline practices, and family functioning. Compared with controls, intervention families demonstrated improved quality of parent-child interactions on scales of parental warmth and affection (Effect size (ES) = 0.25 caregivers; 0.26 children, both p quality (ES = -0.37, p children, p children and caregivers also reported an effect on relationship quality based on a locally derived measure (ES = 0.40 caregivers, p children, p Family functioning was improved, including family cohesion (ES = 0.46 caregivers; 0.36 children; both p children, p Family communication also improved according to children only (ES = 0.29, p children, reported decreased harsh discipline (ES = -0.39, p family well-being for migrant children and caregivers in a middle-income country. The strongest effects were on parent-child relationship quality and family functioning, while results were mixed on changes in discipline practices. Results suggest that a behavioral family-based approach implemented by lay providers in community settings is a promising intervention approach for strengthening families in highly stressed contexts. Clinicaltrials.gov: NCT01668992.

Effect of animal-assisted interventions on depression, agitation and quality of life in nursing home residents suffering from cognitive impairment or dementia: a cluster randomized controlled trial.

Science.gov (United States)

Olsen, Christine; Pedersen, Ingeborg; Bergland, Astrid; Enders-Slegers, Marie-José; Patil, Grete; Ihlebaek, Camilla

2016-12-01

The prevalence of neuropsychiatric symptoms in cognitively impaired nursing home residents is known to be very high, with depression and agitation being the most common symptoms. The possible effects of a 12-week intervention with animal-assisted activities (AAA) in nursing homes were studied. The primary outcomes related to depression, agitation and quality of life (QoL). A prospective, cluster randomized multicentre trial with a follow-up measurement 3 months after end of intervention was used. Inclusion criteria were men and women aged 65 years or older, with a diagnosis of dementia or having a cognitive deficit. Ten nursing homes were randomized to either AAA with a dog or a control group with treatment as usual. In total, 58 participants were recruited: 28 in the intervention group and 30 in the control group. The intervention consisted of a 30-min session with AAA twice weekly for 12 weeks in groups of three to six participants, led by a qualified dog handler. Norwegian versions of the Cornell Scale for Depression, the Brief Agitation Rating Scale and the Quality of Life in Late-stage Dementia scale were used. A significant effect on depression and QoL was found for participants with severe dementia at follow-up. For QoL, a significant effect of AAA was also found immediately after the intervention. No effects on agitation were found. Animal-assisted activities may have a positive effect on symptoms of depression and QoL in older people with dementia, especially those in a late stage. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Quality control of 192Ir high dose rate after loading brachytherapy dose veracity

International Nuclear Information System (INIS)

Feng Zhongsu; Xu Xiao; Liu Fen

2008-01-01

Recently, 192 Ir high dose rate (HDR) afterloading are widely used in brachytherapy. The advantage of using HDR systems over low dose rate systems are shorter treatment time and higher fraction dose. To guarantee the veracity of the delivery dose, several quality control methods are deseribed in this work. With these we can improve the position precision, time precision and dose precision of the brachytherapy. (authors)

Can Ashi points stimulation have specific effects on shoulder pain? A systematic review of randomized controlled trials.

Science.gov (United States)

Wang, Kang-Feng; Zhang, Li-Juan; Lu, Feng; Lu, Yong-Hui; Yang, Chuan-Hua

2016-06-01

To provide an evidence-based overview regarding the efficacy of Ashi points stimulation for the treatment of shoulder pain. A comprehensive search [PubMed, Chinese Biomedical Literature Database, China National Knowledge Infrastructure (CNKI), Chongqing Weipu Database for Chinese Technical Periodicals (VIP) and Wanfang Database] was conducted to identify randomized or quasi-randomized controlled trials that evaluated the effectiveness of Ashi points stimulation for shoulder pain compared with conventional treatment. The methodological quality of the included studies was assessed using the Cochrane risk of bias tool. RevMan 5.0 was used for data synthesis. Nine trials were included. Seven studies assessed the effectiveness of Ashi points stimulation on response rate compared with conventional acupuncture. Their results suggested significant effect in favour of Ashi points stimulation [odds ratio (OR): 5.89, 95% confidence interval (CI): 2.97 to 11.67, Pfirm conclusion could not be reached until further studies of high quality are available.

Random-phase metasurfaces at optical wavelengths

DEFF Research Database (Denmark)

Pors, Anders; Ding, Fei; Chen, Yiting

2016-01-01

, with statistics obeying the theoretical predictions. We foresee the use of random-phase metasurfaces for camouflage applications and as high-quality reference structures in dark-field microscopy, while the control of the statistics for polarised and unpolarised light might find usage in security applications...

Clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns: study protocol for a randomized controlled trial.

Science.gov (United States)

Rashaan, Zjir M; Krijnen, Pieta; van den Akker-van Marle, M Elske; van Baar, Margriet E; Vloemans, Adrianus F P; Dokter, Jan; Tempelman, Fenike R H; van der Vlies, Cees H; Breederveld, Roelf S

2016-03-05

Partial thickness burns are painful, difficult to manage and can have a negative effect on quality of life through scarring, permanent disfigurement and loss of function. The aim of burn treatment in partial thickness burns is to save lives, stimulate wound healing by creating an optimumly moist wound environment, to have debriding and analgesic effects, protect the wound from infection and be convenient for the patient and caregivers. However, there is no consensus on the optimal treatment of partial thickness wounds. Flaminal® and Flamazine® are two standard treatment options that provide the above mentioned properties in burn treatment. Nevertheless, no randomized controlled study has yet compared these two common treatment modalities in partial thickness burns. Thus, the aim of this study is to evaluate the clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns. In this two-arm open multi-center randomized controlled trial, 90 patients will be randomized between Flaminal® and Flamazine® and followed for 12 months. The study population will consist of competent or temporarily non-competent (because of sedation and/or intubation) patients, 18 years of age or older, with acute partial thickness burns and a total body surface area (TBSA) of less than 30 %. The main study outcome is time to complete re-epithelialization (greater than 95 %). Secondary outcome measures include need for grafting, wound colonization/infection, number of dressing changes, pain and anxiety, scar formation, health-related quality of life (HRQoL), and costs. This study will contribute to the optimal treatment of patients with partial thickness burn wounds and will provide evidence on the (cost-)effectiveness and quality of life of Flaminal® versus Flamazine® in the treatment of partial thickness burns. Netherlands Trial Register NTR4486 , registered on 2 April 2014.

Statistical method for quality control in presence of measurement errors

International Nuclear Information System (INIS)

Lauer-Peccoud, M.R.

1998-01-01

In a quality inspection of a set of items where the measurements of values of a quality characteristic of the item are contaminated by random errors, one can take wrong decisions which are damageable to the quality. So of is important to control the risks in such a way that a final quality level is insured. We consider that an item is defective or not if the value G of its quality characteristic is larger or smaller than a given level g. We assume that, due to the lack of precision of the measurement instrument, the measurement M of this characteristic is expressed by ∫ (G) + ξ where f is an increasing function such that the value ∫ (g 0 ) is known and ξ is a random error with mean zero and given variance. First we study the problem of the determination of a critical measure m such that a specified quality target is reached after the classification of a lot of items where each item is accepted or rejected depending on whether its measurement is smaller or greater than m. Then we analyse the problem of testing the global quality of a lot from the measurements for a example of items taken from the lot. For these two kinds of problems and for different quality targets, we propose solutions emphasizing on the case where the function ∫ is linear and the error ξ and the variable G are Gaussian. Simulation results allow to appreciate the efficiency of the different considered control procedures and their robustness with respect to deviations from the assumptions used in the theoretical derivations. (author)

Prospective, randomized, controlled trial of thoracic epidural or patient-controlled opiate analgesia on perioperative quality of life.

LENUS (Irish Health Repository)

Ali, M

2010-03-01

Perioperative epidural analgesia provides continuous pain control and may have advantages over parenteral opiate administration. This study assessed the impact of epidural analgesia on quality of life (QOL) of patients undergoing major surgery.

The impact of a family skills training intervention among Burmese migrant families in Thailand: A randomized controlled trial.

Directory of Open Access Journals (Sweden)

Eve S Puffer

Full Text Available To conduct a randomized controlled trial assessing the impact of a family-based intervention delivered to Burmese migrant families displaced in Thailand on parenting and family functioning.Participants included 479 Burmese migrant families from 20 communities in Thailand. Families, including 513 caregivers and 479 children aged 7 to 15 years, were randomized to treatment and waitlist control groups. The treatment group received a 12-session family-based intervention delivered to groups of families by lay facilitators. Adapted standardized and locally derived measures were administered before and after the intervention to assess parent-child relationship quality, discipline practices, and family functioning.Compared with controls, intervention families demonstrated improved quality of parent-child interactions on scales of parental warmth and affection (Effect size (ES = 0.25 caregivers; 0.26 children, both p < 0.05 and negative relationship quality (ES = -0.37, p < 0.001 caregivers; -0.22 children, p < 0.05. Both children and caregivers also reported an effect on relationship quality based on a locally derived measure (ES = 0.40 caregivers, p < .001; 0.43 children, p < .05. Family functioning was improved, including family cohesion (ES = 0.46 caregivers; 0.36 children; both p < 0.001 and decreased negative interactions (ES = -0.30 caregivers, p < 0.01; -0.24 children, p < 0.05. Family communication also improved according to children only (ES = 0.29, p < 0.01. Caregivers, but not children, reported decreased harsh discipline (ES = -0.39, p < 0.001, and no effects were observed on use of positive discipline strategies. Treatment attendance was high, with participants attending a mean of 9.7 out of 12 sessions.The intervention increased protective aspects of family well-being for migrant children and caregivers in a middle-income country. The strongest effects were on parent-child relationship quality and family functioning, while results were

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

2017-01-28

Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a

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.

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.

Impact of a mindfulness stress management program on stress, anxiety, depression and quality of life in women with polycystic ovary syndrome: a randomized controlled trial.

Science.gov (United States)

Stefanaki, Charikleia; Bacopoulou, Flora; Livadas, Sarantis; Kandaraki, Anna; Karachalios, Athanasios; Chrousos, George P; Diamanti-Kandarakis, Evanthia

2015-01-01

Polycystic ovary syndrome (PCOS) is a common endocrine disorder with a significant psychological burden throughout the life course of affected women. Thus, use of mindful awareness may be beneficial as an adjunct to conventional medical management of women with PCOS. A randomized, controlled trial was conducted at the Evgenideion Hospital of the Athens University Medical School to explore the impact of an 8-week mindfulness stress management program on measures of depression, anxiety and stress as well as on the quality of life in reproductive age women with PCOS. The study was approved by the Research Ethics Committee. Twenty-three and 15 women with PCOS were randomly allocated to the intervention or control group, respectively. All participants were administered DASS21, PSS-14, PCOSQ, Daily Life and General Life Satisfaction Questionnaires and provided three-timed daily samples of salivary cortisol, before and after the intervention. Intervention group participants were provided with the Credibility/Expectancy Questionnaire at the day of enrolment, to check for possible placebo effect on the outcome. Post-intervention, between-group results revealed statistically significant reductions in stress, depressive and anxiety symptoms, as well as in salivary cortisol concentrations, along with an increase in Life Satisfaction and Quality of Life scores in the intervention group only. There was no significant "placebo" effect on the outcome measures. Mindfulness techniques seem promising in ameliorating stress, anxiety, depression and the quality of life in women with PCOS and could be used as an adjunct method to the conventional management of these women.

Effectiveness of a physical activity program on weight, physical fitness, occupational stress, job satisfaction and quality of life of overweight employees in high-tech industries: a randomized controlled study.

Science.gov (United States)

Fang, Yun-Ya; Huang, Chien-Yuan; Hsu, Mei-Chi

2018-03-27

This study aimed to examine the effectiveness of a physical activity (PA) program on weight control, physical fitness, occupational stress, job satisfaction and quality of life of overweight and sedentary employees in high-tech industries. Participants in the intervention group (n = 37) were instructed to carry out a PA program at moderate intensity for 60 min/session, 3 sessions/week for 12 weeks. Those in the control group (n = 38) received no PA program and were asked to continue their routine lifestyle. Evaluations were performed at baseline and at the end of the intervention. Results of structured questionnaires and blood biochemistry tests and evaluations of physical fitness were analyzed. The PA program effectively reduced the number of risk factors for metabolic syndrome and body fat percentage, and improved physical fitness such as flexibility, muscular strength and endurance and cardiorespiratory endurance. The intervention also significantly decreased levels of serum triglyceride, total cholesterol and low-density lipoprotein cholesterol. Significant positive effects on work control, interpersonal relationships at work, global job satisfaction and quality of life were also demonstrated. This study showed that a PA program can be helpful in improving physical, physiological and psychological outcomes for overweight and sedentary employees in high-tech industries.

EFFECT OF HIGH INTENSITY INTERVAL TRAINING ON ENDOTHELIAL FUNCTION IN POSTMENOPAUSAL HYPERTENSIVE PATIENTS RANDOMIZED CONTROLLED TRIAL

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Mona Mohamed Taha

2016-02-01

Full Text Available Background: Postmenopausal hypertension is the most common risk factor of cardiovascular morbidity and mortality. As the exercises training conveys benefits of the setting of secondary prevention of hypertension. High intensity interval training (HIIT emerged as a new form of physical training and presents as therapeutic alternative to patients and health care professionals. This study aimed to investigate the effect of high intensity interval training on endothelial function in postmenopausal hypertension. Methods: Forty six mildly hypertensive postmenopausal women, their ages ranged from (45-55 years old, were randomly allocated to two groups: HIIT group (group-I; n=23 performed a high intensity interval training 3 times a week for 10 weeks at an intensity of (80-85% HR max for 40 minutes and control group (group-II; n=23 remains sedentary during this period. Serum nitric oxide (NO, vascular endothelial growth factor levels (VEGF and blood pressures were measured before and after intervention. Results: A significant reduction in both systolic and diastolic blood pressure values by 9.5% and 7 % respectively, was seen after high intensity interval training which was accompanied by increase in NO and VEGF levels by 43.3% and 15.2 % respectively, while no significant change observed in the control group. Conclusion: High intensity interval training had obvious benefits in improving plasma No, VEGF concentrations and controlling hypertension in postmenopausal women.

Chemotherapy-Related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients with, or without, High Protein Nutritional Support. A Prospective, Randomized Study

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Monika Ziętarska

2017-10-01

Full Text Available Background: Cancer disease is usually associated with impaired nutritional status, which is one of the factors contributing to deterioration of the results of surgery, chemotherapy or radiotherapy. Objectives: The aim of the study was to determine whether nutritional support with high protein (ONS in adult oncologic patients in the first step of cancer cachexia—asymptomatic precachexia, has an influence on the toxicity of systemic therapy. However, secondary endpoints were established: to determine whether high protein ONS influences the nutritional status, the quality of life, and the performance status. Materials and Methods: A total of 114 persons aged 40–84 years old with colorectal cancer were examined. Based on the randomization, 47 patients were qualified to the interventional group (ONS group and 48 to Control group. To evaluate the nutritional status NRS-2002 (Nutritional Risk Screening, SGA (Subjective Global Assessment, SCRINIO (SCReenIng the Nutritional status In Oncology Working Group classification, VAS (Visual Analog Scale for appetite was used. FAACT (Functional Assessment of Anorexia/Cachexia Therapy questionnaire was used for assessment of the quality of life. The health status of patients was evaluated based on the Karnofsky Performance Scale. Anthropometric measurements were done. Results: Severe complications of chemotherapy, which caused the end of treatment, a slight complication of the gastrointestinal tract such as diarrhea grade 2 according to ECOG (Eastern Cooperative Oncology Group score regardless of the studied group, were observed. There were no statistical differences in the number and severity of the observed complications, i.e., neutropenia, leucopenia, thrombocytopenia, anemia, abdominal pain, nausea and vomiting, and diarrhea. During the follow-up the significant changes of SGA, VAS, albumin and prealbumin were observed between groups. In the ONS group an improvement in nutritional status was noticed

A Randomized Control Study on Psycho-Education Group on Improving Health-Related Quality of Life of Chinese Persons with Major Neurocognitive Disorder.

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Young, Kim-Wan

2016-01-01

People with a major neurocognitive disorder (PwND) are found to have a lower health related quality of life (HRQoL) than those without neurocognitive disorder. This research study aims to evaluate the effectiveness of a psycho-education group in improving the HRQoL of Chinese PwND. By adopting randomized control trial (RCT), Chinese PwND were randomly assigned to either a 10-session psycho-education group or the control group. Family caregivers of treatment group were encouraged to take part in two sessions focusing on the caring and communication skills. Control group and their family caregivers received standardized educational materials on basic information on neurocognitive disorder for them to read at home. Standardized assessment was conducted both with PwND and their caregivers independently to give the self-rated and caregiver-rated HRQoL of PwND in the pre- and post- treatment periods by a research assistant who was blind to the group assignment of the participants. Moreover, qualitative interviews were also conducted for ten participants and five family caregivers of the treatment group to identify those group elements relating to its effectiveness. 2 × 2 repeated measures ANCOVA demonstrated that the treatment group (n = 32) was significantly more effective than the control group (n = 32) in improving the caregiver-rated HRQoL (F[1, 61] = 4.35, p = .04 psycho-education group significantly improves caregiver-rated HRQoL of PwND, supporting the feasibility and effectiveness of the psycho-education group.

Do manual therapy techniques have a positive effect on quality of life in people with tension-type headache? A randomized controlled trial.

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Espí-López, Gemma V; Rodríguez-Blanco, Cleofás; Oliva-Pascual-Vaca, Angel; Molina-Martínez, Francisco; Falla, Deborah

2016-08-01

Controversy exists regarding the effectiveness of manual therapy for the relief of tension-type headache (TTH). However most studies have addressed the impact of therapy on the frequency and intensity of pain. No studies have evaluated the potentially significant effect on the patient's quality of life. To assess the quality of life of patients suffering from TTH treated for 4 weeks with different manual therapy techniques. Factorial, randomized, single-blinded, controlled clinical trial. Specialized center for the treatment of headache. Seventy-six (62 women) patients aged between 18 and 65 years (age: 39.9±10.9) with either episodic or chronic TTH. Patients were divided into four groups: suboccipital inhibitory pressure; suboccipital spinal manipulation; a combination of the two treatments; control. Quality of life was assessed using the SF-12 questionnaire (considering both the overall score and the different dimensions) at the beginning and end of treatment, and after a one month follow-up. Compared to baseline, the suboccipital inhibition treatment group showed a significant improvement in their overall quality of life at the one month follow-up and also showed specific improvement in the dimensions related to moderate physical activities, and in their emotional role. All the treatment groups, but not the control group, showed improvements in their physical role, bodily pain, and social functioning at the one month follow-up. Post treatment and at the one month follow-up, the combined treatment group showed improved vitality and the two treatment groups that involved manipulation showed improved mental health. All three treatments were effective at changing different dimensions of quality of life, but the combined treatment showed the most change. The results support the effectiveness of treatments applied to the suboccipital region for patients with TTH. Manual therapy techniques applied to the suboccipital region, for as little as four weeks, offered a

The influence of fidelity of implementation on teacher-student interaction quality in the context of a randomized controlled trial of the Responsive Classroom approach.

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Abry, Tashia; Rimm-Kaufman, Sara E; Larsen, Ross A; Brewer, Alexis J

2013-08-01

This study examined the direct and indirect effects between training in the Responsive Classroom® (RC) approach, teachers' uptake of RC practices, and teacher-student interaction quality, using a structural equation modeling framework. A total of 24 schools were randomly assigned to experimental or control conditions. Third- and fourth-grade teachers in treatment schools (n=132) received training in the RC approach, whereas teachers in control schools (n=107) continued "business as usual." Observers rated teachers' fidelity of implementation (FOI) of RC practices 5 times throughout the year using the Classroom Practices Observation Measure. In addition, teachers completed self-report measures of FOI, the Classroom Practices Teacher Survey and Classroom Practices Frequency Survey, at the end of the school year. Teacher-student interactions were rated during classroom observations using the Classroom Assessment Scoring System. Controlling for teachers' grade level and teacher-student interaction quality at pretest, RC training was expected to predict posttest teacher-student interaction quality directly and indirectly through FOI. Results supported only a significant indirect effect, β=0.85, p=.002. Specifically, RC teachers had higher levels of FOI of RC practices, β=1.62, pteacher-student interaction quality, β=0.52, p=.001, R2=.32. Discussion highlights factors contributing to variability in FOI and school administrators roles in supporting FOI. Copyright © 2013 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study

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Li, Jing; Kang, Jian; Wang, Changzheng; Yang, Jing; Wang, Linda; Kottakis, Ioannis; Humphries, Michael

2016-01-01

Purpose Omalizumab is the preferred add-on therapy for patients with moderate-to-severe persistent allergic asthma and has demonstrated efficacy and safety in various ethnicities. This study evaluated the efficacy and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma. Methods This randomized, double-blind, parallel-group, placebo-controlled, phase III study assessed lung function, quality of life, asthma control, and safety of omalizumab after 24-week therapy in Chinese patients (18-75 years of age). Results A total of 616 patients were randomized (1:1) to omalizumab or placebo. The primary endpoint, least squares mean treatment difference (LSM-TD) in morning peak expiratory flow (PEF) (omalizumab vs placebo), at Weeks >20-24 was 8.85 L/min (Full analysis set; P=0.062). Per-protocol analysis set showed significant improvements with LSM-TD of 11.53 L/min in mean mPEF at Weeks >20-24 (P=0.022). The FEV1 % predicted was significantly improved with omalizumab vs placebo from 8 to 24 weeks (after 24-week treatment: LSM-TD=4.12%; P=0.001). At Week 24, a higher proportion of omalizumab-treated patients achieved clinically relevant improvements in standardized AQLQ (58.2% vs 39.3%; LSM=0.51 vs 0.10; Pquality of life, and asthma control in Chinese patients with moderate-to-severe persistent allergic asthma and has a good safety profile. PMID:27126725

Influence of manual lymphatic drainage on health-related quality of life and symptoms of chronic venous insufficiency: a randomized controlled trial.

Science.gov (United States)

dos Santos Crisóstomo, Rute Sofia; Costa, Daniela Sofia Albino; de Luz Belo Martins, Catarina; Fernandes, Tânia Isabel Russo; Armada-da-Silva, Paulo A

2015-02-01

To evaluate the efficacy of manual lymphatic drainage (MLD) in improving health-related quality of life (HRQOL), symptomatology, and physical status in patients with chronic venous insufficiency (CVI). Single-blind randomized controlled trial. Health community attendant service. Subjects with CVI (N=41) were randomly assigned to an experimental group (n=20; mean age, 54.6±11.3y) or control group (n=21; mean age, 46.8±11.1y). The experimental group completed 10 lower extremity MLD sessions over 4 weeks and 1 educational session. The control group only attended the educational session. Outcome measures were taken at baseline (t0), at the end of 4 weeks (t1), and after 2 months for follow-up (t2). HRQOL was assessed with the Chronic Venous Insufficiency Quality of Life Questionnaire-20, symptoms (fatigue, heaviness) were assessed with a visual analog scale, severity of the disease was assessed with the Venous Clinical Severity Score (VCSS) (total score, score for each item), leg volumetry was assessed with perimeters, and plantar/dorsiflexion strength and ankle range of motion (ROM) were assessed with dynamometry. A significant interaction group×time effect was found for pain on HRQOL (F2,78=3.507; P=.035; partial η2=.087), clinical severity (F2,78=5.231; P=.007; partial η2=.118), especially for venous edema (assessed with the VCSS), fatigue (F1.67,65.21=4.690; P=.012; partial η2=.107), and heaviness (F1.57,61.32=9.702; P=.001; partial η2=.199), with the experimental group improving from t0 to t1 and t0 to t2 in all of these outcomes. No effect of MLD treatment could be found for ankle muscle strength, ankle ROM, and leg volume. Short-term MLD treatment ameliorates CVI severity and related edema, symptoms, and pain HRQOL in patients with CVI. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Effect of Regular Resistance Training on Motivation, Self-Perceived Health, and Quality of Life in Previously Inactive Overweight Women: A Randomized, Controlled Trial.

Science.gov (United States)

Heiestad, Hege; Rustaden, Anne Mette; Bø, Kari; Haakstad, Lene A H

2016-01-01

Objectives. The aim was to investigate the effects of three different types of resistance training implementation. Design. Randomized controlled trial. Methods. Inactive, overweight women (n = 143), mean BMI 31.3 ± 5.2 kg/m(2), mean age 39.9 ± 10.5 years, were randomized to one of the following groups: A (BodyPump group training), B (individual follow-up by a personal trainer), C (nonsupervised exercise), or D (controls). The intervention included 12 weeks of 45-60 minutes' full-body resistance training three sessions per week. The outcomes in this paper are all secondary outcome measures: exercise motivation, self-perceived health, and quality of life. Results. Adherence averaged 26.1 ± 10.3 of 36 prescribed sessions. After the intervention period, all three training groups (A-C) had better scores on exercise motivation (A = 43.9 ± 19.8, B = 47.6 ± 15.4, C = 48.4 ± 17.8) compared to the control group (D) (26.5 ± 18.2) (p training contributed to higher scores in important variables related to exercise motivation and self-perceived health. Low adherence showed that it was difficult to motivate previously inactive, overweight women to participate in regular strength training.

Effect of an integrated approach of yoga therapy on quality of life in osteoarthritis of the knee joint: A randomized control study

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John Ebnezar

2011-01-01

Full Text Available Aim: This study was designed to evaluate the efficacy of addition of integrated yoga therapy to therapeutic exercises in osteoarthritis (OA of knee joints. Materials and Methods: This was a prospective randomized active control trial. A total of t participants with OA of knee joints between 35 and 80 years (yoga, 59.56 ± 9.54 and control, 59.42 ± 10.66 from the outpatient department of Dr. John′s Orthopedic Center, Bengaluru, were randomly assigned to receive yoga or physiotherapy exercises after transcutaneous electrical stimulation and ultrasound treatment of the affected knee joints. Both groups practiced supervised intervention (40 min per day for 2 weeks (6 days per week with followup for 3 months. The module of integrated yoga consisted of shithilikaranavyayama (loosening and strengthening, asanas, relaxation techniques, pranayama, meditation and didactic lectures on yama, niyama, jnana yoga, bhakti yoga, and karma yoga for a healthy lifestyle change. The control group also had supervised physiotherapy exercises. A total of 118 (yoga and 117 (control were available for final analysis. Results: Significant differences were observed within (P < 0.001, Wilcoxon′s and between groups (P < 0.001, Mann-Whitney U-test on all domains of the Short Form-36 (P < 0.004, with better results in the yoga group than in the control group, both at 15 th day and 90 th day. Conclusion: An integrated approach of yoga therapy is better than therapeutic exercises as an adjunct to transcutaneous electrical stimulation and ultrasound treatment in improving knee disability and quality of life in patients with OA knees.

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)

Quality Management, Quality Assurance and Quality Control in Blood Establishments

OpenAIRE

Bolbate, N

2008-01-01

Quality terms and the roots of the matter are analyzed according to European Committee’s recommendations. Essence of process and product quality control as well as essence of quality assurance is described. Quality system’s structure including quality control, quality assurance and management is justified in the article.

The Effects of a Mobile Phone Application on Quality of Life in Patients With Type 1 Diabetes Mellitus: A Randomized Controlled Trial.

Science.gov (United States)

Drion, Iefke; Pameijer, Loes R; van Dijk, Peter R; Groenier, Klaas H; Kleefstra, Nanne; Bilo, Henk J G

2015-05-11

The combination of an increasing prevalence of diabetes mellitus and more people having access to smartphones creates opportunities for patient care. This study aims to investigate whether the use of the Diabetes Under Control (DBEES) mobile phone application, a digital diabetes diary, results in a change in quality of life for patients with type 1 diabetes mellitus (T1DM) compared with the standard paper diary. In this randomized controlled open-label trial, 63 patients with T1DM having access to a smartphone were assigned to the intervention group using the DBEES application (n = 31) or the control group using the standard paper diary (n = 32). Primary outcome was the change in quality of life, as measured by the RAND-36 questionnaire, between both groups. Secondary outcomes included diabetes-related distress (PAID), HbA1c, frequency of self-monitoring blood glucose, and the usability of the diabetes application (SUS). Patients had a median age (IQR) of 33 (21) years, diabetes duration of 17 (16) years, and an HbA1c of 62 ± 16 mmol/mol. No significant differences in the QOL, using the RAND-36, within and between both groups were observed after 3 months. Glycemic control, diabetes-related emotional distress, and frequency of self-monitoring of blood glucose remained within and between groups. Users reviewed the usability of DBEES with a 72 ± 20, on a range of 0-100. The use of the DBEES application in the management of patients with T1DM for 3 months yields no alterations in quality of life compared to the standard paper diary. © 2015 Diabetes Technology Society.

Tai Chi for Lower Urinary Tract Symptoms and Quality of Life in Elderly Patients with Benign Prostate Hypertrophy: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Seil Jung

2012-01-01

Full Text Available Tai chi exercise has been recommended as suitable for the improvement of health in the elderly. The purpose of this study was to investigate the effects of tai chi on lower urinary tract symptoms (LUTSs, quality of life (QoL, and sex hormone levels in patients with benign prostate hypertrophy (BPH. The elderly patients with BPH were randomized to receive tai chi or usual care. Fifty-six participants were randomized into either the tai chi group (n=28 or the control group (n=28. After 12 weeks of treatment, the tai chi group showed significant improvement in LUTS and QoL. There was a significant effect of tai chi on testosterone but no significant effect on insulin or glucose. No serious adverse events were observed during the study period. In conclusion, our results suggest that 12 weeks of tai chi may improve LUTS and QoL in elderly patients with BPH.

Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial.

Science.gov (United States)

Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W

2015-04-01

Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Impact of a Mental Health Curriculum on Knowledge and Stigma Among High School Students: A Randomized Controlled Trial.

Science.gov (United States)

Milin, Robert; Kutcher, Stanley; Lewis, Stephen P; Walker, Selena; Wei, Yifeng; Ferrill, Natasha; Armstrong, Michael A

2016-05-01

This study evaluated the effectiveness of a school-based mental health literacy intervention for adolescents on knowledge and stigma. A total of 24 high schools and 534 students in the regional area of Ottawa, Ontario, Canada participated in this randomized controlled trial. Schools were randomly assigned to either the curriculum or control condition. The curriculum was integrated into the province's grade 11 and 12 "Healthy Living" courses and was delivered by teachers. Changes in mental health knowledge and stigma were measured using pre- and posttest questionnaires. Descriptive analyses were conducted to provide sample characteristics, and multilevel modeling was used to examine study outcomes. For the curriculum condition, there was a significant change in stigma scores over time (p = .001), with positive attitudes toward mental illness increasing from pre to post. There was also a significant change in knowledge scores over time (p mental health (p mental health literacy of an integrated, manualized mental health educational resource for high school students on knowledge and stigma. Findings also support the applicability by teachers and suggest the potential for broad-based implementation of the educational curriculum in high schools. Replication and further studies are warranted. Clinical trial registration information-Impact of a Mental Health Curriculum for High School Students on Knowledge and Stigma; http://clinicaltrials.gov/; NCT02561780. Copyright © 2016 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Validity of Qualis database as a predictor of evidence hierarchy and risk of bias in randomized controlled trials: a case study in dentistry

Directory of Open Access Journals (Sweden)

Christiane Alves Ferreira

2011-01-01

Full Text Available OBJECTIVE: To evaluate the validity of the Qualis database in identifying the levels of scientific evidence and the quality of randomized controlled trials indexed in the Lilacs database. METHODS: We selected 40 open-access journals and performed a page-by-page hand search, to identify published articles according to the type of study during a period of six years. Classification of studies was performed by independent reviewers assessed for their reliability. Randomized controlled trials were identified for separate evaluation of risk of bias using four dimensions: generation of allocation sequence, allocation concealment, blinding, and incomplete outcome data. The Qualis classification was considered to be the outcome variable. The statistical tests used included Kappa, Spearman's correlation, Kendall-tau and ordinal regressions. RESULTS: Studies with low levels of scientific evidence received similar Qualis classifications when compared to studies with high levels of evidence. In addition, randomized controlled trials with a high risk of bias for the generation of allocation sequences and allocation concealment were more likely to be published in journals with higher Qualis levels. DISCUSSION: The hierarchy level of the scientific evidence as classified by type of research design, as well as by the validity of studies according to the bias control level, was not correlated or associated with Qualis stratification. CONCLUSION: Qualis classifications for journals are not an approximate or indirect predictor of the validity of randomized controlled trials published in these journals and are therefore not a legitimate or appropriate indicator of the validity of randomized controlled trials.

Feasibility and preliminary effectiveness of ice therapy in patients with an acute tear in the gastrocnemius muscle: A pilot randomized controlled trial

NARCIS (Netherlands)

Prins, J.C.M.; Stubbe, J.H.; Meeteren, N.L.U. van; Scheffers, F.A.; Dongen, M.C.J.M. van

2011-01-01

Objective: To investigate the feasibility of a randomized controlled trial and the preliminary effectiveness of ice therapy in the acute phase of a gastrocnemius tear for the quality of functional recovery. Design: A pilot version of an intended prospective randomized controlled clinical trial was

Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

Science.gov (United States)

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2013-09-01

Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. We evaluated a rural participatory women's group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14,576 and 20,576 births were recorded during baseline (June 2007-September 2008) and intervention (October 2008-December 2010) periods. For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60-1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72-0.97). We did not observe any intervention effects on maternal mortality. Despite implementation problems, a combined community and facility approach using participatory women's groups and quality improvement at health centres reduced newborn mortality in rural Malawi.

Concrete and steel construction quality control and assurance

CERN Document Server

El-Reedy, Mohamed A

2014-01-01

Starting with the receipt of materials and continuing all the way through to the final completion of the construction phase, Concrete and Steel Construction: Quality Control and Assurance examines all the quality control and assurance methods involving reinforced concrete and steel structures. This book explores the proper ways to achieve high-quality construction projects, and also provides a strong theoretical and practical background. It introduces information on quality techniques and quality management, and covers the principles of quality control. The book presents all of the quality control and assurance protocols and non-destructive test methods necessary for concrete and steel construction projects, including steel materials, welding and mixing, and testing. It covers welding terminology and procedures, and discusses welding standards and procedures during the fabrication process, as well as the welding codes. It also considers the total quality management system based on ISO 9001, and utilizes numer...

Internet-based home training is capable to improve balance in multiple sclerosis: a randomized controlled trial.

Science.gov (United States)

Frevel, D; Mäurer, M

2015-02-01

Balance disorders are common in multiple sclerosis. Aim of the study is to investigate the effectiveness of an Internet-based home training program (e-Training) to improve balance in patients with multiple sclerosis. A randomized, controlled study. Academic teaching hospital in cooperation with the therapeutic riding center Gut Üttingshof, Bad Mergentheim. Eighteen multiple sclerosis patients (mean EDSS 3,5) took part in the trial. Outcome of patients using e-Training (N.=9) was compared to the outcome of patients receiving hippotherapy (N.=9), which can be considered as an advanced concept for the improvement of balance and postural control in multiple sclerosis. After simple random allocation patients received hippotherapy or Internet-based home training (balance, postural control and strength training) twice a week for 12 weeks. Assessments were done before and after the intervention and included static and dynamic balance (primary outcome). Isometric muscle strength of the knee and trunk extension/flexion (dynamometer), walking capacity, fatigue and quality of life served as secondary outcome parameters. Both intervention groups showed comparable and highly significant improvement in static and dynamic balance capacity, no difference was seen between the both intervention groups. However looking at fatigue and quality of life only the group receiving hippotherapy improved significantly. Since e-Training shows even comparable effects to hippotherapy to improve balance, we believe that the established Internet-based home training program, specialized on balance and postural control training, is feasible for a balance and strength training in persons with multiple sclerosis. We demonstrated that Internet-based home training is possible in patients with multiple sclerosis.

TEACCH-based group social skills training for children with high-functioning autism: a pilot randomized controlled trial.

Science.gov (United States)

Ichikawa, Kayoko; Takahashi, Yoshimitsu; Ando, Masahiko; Anme, Tokie; Ishizaki, Tatsuro; Yamaguchi, Hinako; Nakayama, Takeo

2013-10-01

Although social skills training programs for people with high-functioning autism (HFA) are widely practiced, the standardization of curricula, the examination of clinical effectiveness, and the evaluation of the feasibility of future trials have yet to be done in Asian countries. To compensate for this problem, a Japanese pilot randomized controlled trial (RCT) of the Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted. Eleven children with HFA, aged 5-6 years, and their mothers were randomly assigned to the TEACCH program (n=5) or a waiting-list control group (n=6). The program involved comprehensive group intervention and featured weekly 2-hour sessions, totaling 20 sessions over six months. The adaptive behaviors and social reciprocity of the children, parenting stress, and parent-child interactions were assessed using the Strengths and Difficulties Questionnaire (SDQ), Parenting Stress Index (PSI), Beck depression inventory-II (BDI-II), and Interaction Rating Scale (IRS). Through this pilot trial, the intervention and evaluation of the program has been shaped. There were no dropouts from the program and the mothers' satisfaction was high. The outcome measurements improved more in the program group than in the control group, with moderate effect sizes (SDQ, 0.71; PSI, 0.58; BDI-II, 0.40; and IRS, 0.69). This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not. We have standardized the TEACCH program, confirmed the feasibility of a future trial, and successfully estimated the positive effect size. These findings will contribute to a larger trial in the future and to forthcoming systematic reviews with meta-analyses. UMIN000004560.

Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

Science.gov (United States)

Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

2018-05-01

Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p Home patients were more physically active (median minutes, 209 vs. 78; p home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

Descriptive study of the quality control in mammography

International Nuclear Information System (INIS)

Gaona, E.; Perdigon C, G.M.; Casian C, G.A.; Azorin N, J.; Diaz G, J.A.I.; Arreola, M.

2005-01-01

The goal of mammography is to provide contrast between a lesion that is possible residing within the breast and normal surrounding tissue. Quality control is essential for maintaining the contrast imaging performance of a mammography system and incorporate tests that are relevant in that they are predictive of future degradation of contrast imaging performance. These tests will also be done at frequency that is high enough to intercept most drifts in quality imaging or performance before they become diagnostically significant. The quality control study has as objective to describe the results of the assessment of quality imaging elements (film optical density, contrast (density difference), uniformity, resolution and noise) of 62 mammography departments without quality control program and comparison these results with a mammography reference department with a quality control program. When comparing the results they allow seeing the clinical utility of to have a quality control program to reduce the errors of mammography interpretation. (Author)

A randomized controlled trial on the effects of combined aerobic-resistance exercise on muscle strength and fatigue, glycemic control and health-related quality of life of type 2 diabetes patients.

Science.gov (United States)

Tomas-Carus, Pablo; Ortega-Alonso, Alfredo; Pietilainen, Kirsi H; Santos, Vitoria; Goncalves, Helena; Ramos, Jorge; Raimundo, Armando

2016-05-01

The aim of this paper was to evaluate the effects of a 12-weeks combined aerobic-resistance exercise therapy on fatigue and isokinetic muscle strength, glycemic control and health-related quality of life (HRQoL) in moderately affected type 2 diabetes (T2DM) patients. A randomized controlled trial design was employed. Forty-three T2DM patients were assigned to an exercise group (N.=22), performing 3 weekly sessions of 60 minutes of combined aerobic-resistance exercise for 12-weeks; or a no exercise control group (N.=21). Both groups were evaluated at a baseline and after 12-weeks of exercise therapy for: 1) muscle strength and fatigue by isokinetic dynamometry; 2) plasma glycated hemoglobin A1C (HbA1C); and 3) HRQoL utilizing the SF-36 questionnaire. The exercise therapy led to improvements in muscle fatigue in knee extensors (-55%) and increased muscle strength in knee flexors and extensors (+15 to +30%), while HbA1C decreased (-18%). In addition, the exercising patients showed sizeable improvements in HRQoL: physical function (+53%), vitality (+21%) and mental health (+40%). Twelve-weeks of combined aerobic-resistance exercise was highly effective to improve muscle strength and fatigue, glycemic control and several aspects of HRQoL in T2DM patients. These data encourage the use of aerobic and resistance exercise in the good clinical care of T2DM.

Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

Science.gov (United States)

2014-01-01

Background Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann–Whitney test. Results The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck’s disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0–1) and for the shoulder RCTs 3.0 (range 0–5) (p = 0.012). Conclusion Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically

The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials.

Science.gov (United States)

Liu, Hua; Zeng, Chao; Gao, Shu-guang; Yang, Tuo; Luo, Wei; Li, Yu-sheng; Xiong, Yi-lin; Sun, Jin-peng; Lei, Guang-hua

2013-10-01

A meta-analysis was conducted to examine the effect of mud therapy on pain relief in patients with knee osteoarthritis (OA). A detailed search of PubMed®/MEDLINE® was undertaken to identify randomized controlled trials and prospective comparative studies published before 9 March 2013 that compared mud therapy with control group treatments in patients with knee OA. A quantitative meta-analysis of seven studies (410 patients) was performed. There was a significant difference between the groups in the visual analogue scale pain score (standardized mean difference [SMD] -0.73) and Western Ontario and McMaster Universities Osteoarthritis Index pain score (SMD -0.30), with differences in favour of mud therapy. Mud therapy is a favourable option for pain relief in patients with knee OA. Additional high-quality randomized controlled trials need to be conducted to explore this issue further and to confirm this conclusion.

Effect of a multidisciplinary supportive program for family caregivers of patients with heart failure on caregiver burden, quality of life, and depression: A randomized controlled study.

Science.gov (United States)

Hu, Xiaolin; Dolansky, Mary A; Su, Yonglin; Hu, Xiuying; Qu, Moying; Zhou, Lingjuan

2016-10-01

Caregivers of patients with heart failure experience burden and negative health outcomes. Adequate support for family caregivers improves their well-being and the quality of care provided to the patients. However, little is known about the benefits of interventions for caregivers of patients with heart failure in China. To test the effects of a multidisciplinary supportive program for family caregivers on caregiver burden, quality of life, and depression. A randomized controlled design with repeated measures was used in this study. A total of 118 participants were randomized into experimental (n=59) and control groups (n=59) from May to December 2014 in one hospital in Chengdu, People's Republic of China. Participants in the experimental group received a 3-month multidisciplinary supportive program, consisting of three 60-min sessions of group classes, three 30-min peer support groups, and regular telephone follow-ups and consultations, while participants in the control group received usual care only. Outcomes were caregiver burden, quality of life, and depression. Data were collected at baseline, post-test (3 months after discharge), and 3 months after post-test (6 months after discharge). The repeated measures analysis of variance was used to examine the effects of groups, changes over time, and time-group interaction on outcome variables. There were significant improvements in caregiver burden, mental health, and depression after post-test and 3 months after post-test in the experimental group. However, there was no significant improvement in caregivers' physical health at either 3 or 6 months following discharge. A multidisciplinary supportive program for caregivers of heart failure patients had positive effects and provides a unique perspective of an intervention considering Chinese culture and customs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial.

Science.gov (United States)

Fulkerson, Jayne A; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y

2015-12-15

Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011-2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

Quality control methodology for high-throughput protein-protein interaction screening.

Science.gov (United States)

Vazquez, Alexei; Rual, Jean-François; Venkatesan, Kavitha

2011-01-01

Protein-protein interactions are key to many aspects of the cell, including its cytoskeletal structure, the signaling processes in which it is involved, or its metabolism. Failure to form protein complexes or signaling cascades may sometimes translate into pathologic conditions such as cancer or neurodegenerative diseases. The set of all protein interactions between the proteins encoded by an organism constitutes its protein interaction network, representing a scaffold for biological function. Knowing the protein interaction network of an organism, combined with other sources of biological information, can unravel fundamental biological circuits and may help better understand the molecular basics of human diseases. The protein interaction network of an organism can be mapped by combining data obtained from both low-throughput screens, i.e., "one gene at a time" experiments and high-throughput screens, i.e., screens designed to interrogate large sets of proteins at once. In either case, quality controls are required to deal with the inherent imperfect nature of experimental assays. In this chapter, we discuss experimental and statistical methodologies to quantify error rates in high-throughput protein-protein interactions screens.

Placement and promotion strategies to increase sales of healthier products in supermarkets in low-income, ethnically diverse neighborhoods: a randomized controlled trial.

Science.gov (United States)

Foster, Gary D; Karpyn, Allison; Wojtanowski, Alexis C; Davis, Erica; Weiss, Stephanie; Brensinger, Colleen; Tierney, Ann; Guo, Wensheng; Brown, Jeffery; Spross, Carly; Leuchten, Donna; Burns, Patrick J; Glanz, Karen

2014-06-01

The greater presence of supermarkets in low-income, high-minority neighborhoods has the potential to positively affect diet quality among those at greatest risk of obesity. In-store marketing strategies that draw attention to healthier products may be effective, sustainable, and scalable for improving diet quality and health. Few controlled studies of in-store marketing strategies to promote sales of healthier items in low-income, high-minority neighborhoods have been conducted. The objective of this study was to evaluate the effects of in-store marketing strategies to promote the purchase of specific healthier items in 5 product categories: milk, ready-to-eat cereal, frozen meals, in-aisle beverages, and checkout cooler beverages. The design was a cluster-randomized controlled trial conducted from 2011 to 2012. Eight urban supermarkets in low-income, high-minority neighborhoods were the unit of randomization, intervention, and analysis. Stores were matched on the percentage of sales from government food-assistance programs and store size and randomly assigned to an intervention or control group. The 4 intervention stores received a 6-mo, in-store marketing intervention that promoted the sales of healthier products through placement, signage, and product availability strategies. The 4 control stores received no intervention and were assessment-only controls. The main outcome measure was weekly sales of the targeted products, which was assessed on the basis of the stores' sales data. Intervention stores showed significantly greater sales of skim and 1% milk, water (in aisle and at checkout), and 2 of 3 types of frozen meals compared with control store sales during the same time period. No differences were found between the stores in sales of cereal, whole or 2% milk, beverages, or diet beverages. These data indicate that straightforward placement strategies can significantly enhance the sales of healthier items in several food and beverage categories. Such

Improving depression and enhancing resilience in family dementia caregivers: a pilot randomized placebo-controlled trial of escitalopram.

Science.gov (United States)

Lavretsky, Helen; Siddarth, Prabha; Irwin, Michael R

2010-02-01

This study examined the potential of an antidepressant drug, escitalopram, to improve depression, resilience to stress, and quality of life in family dementia caregivers in a randomized placebo-controlled double-blinded trial. Forty family caregivers (43-91 years of age, 25 children and 15 spouses; 26 women) who were taking care of their relatives with Alzheimer disease were randomized to receive either escitalopram 10 mg/day or placebo for 12 weeks. Severity of depression, resilience, burden, distress, quality of life, and severity of care-recipient's cognitive and behavioral disturbances were assessed at baseline and over the course of the study. The Hamilton Depression Rating Scale scores at baseline ranged between 10 and 28. The groups were stratified by the diagnosis of major and minor depression. Most outcomes favored escitalopram over placebo. The severity of depression improved, and the remission rate was greater with the drug compared with placebo. Measures of anxiety, resilience, burden, and distress improved on escitalopram compared with placebo. Among caregivers, this small randomized controlled trial found that escitalopram use resulted in improvement in depression, resilience, burden and distress, and quality of life. Our results need to be confirmed in a larger sample.

Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis

NARCIS (Netherlands)

Sheffler, L.R.; Taylor, P.N.; Gunzler, D.D.; Buurke, Jaap; IJzerman, Maarten Joost; Chae, J.

2013-01-01

Objective: To compare the motor relearning effect of a surface peroneal nerve stimulator (PNS) versus usual care on lower limb motor impairment, activity limitation, and quality of life among chronic stroke survivors. Design: Single-blinded randomized controlled trial. Setting: Teaching hospital of

A Randomized Controlled Trial of an Eczema Care Plan.

Science.gov (United States)

Rea, Corinna J; Tran, Katherine D; Jorina, Maria; Wenren, Larissa M; Hawryluk, Elena B; Toomey, Sara L

2018-03-02

To test whether an eczema care plan (ECP) would improve provider documentation and management, decrease eczema severity, and increase patient quality of life (QOL) in the pediatric primary care setting. We conducted a randomized controlled trial from June 2015 to September 2016 at a large hospital-based pediatric primary care clinic. Participants included children from 1 month to 16 years of age with a diagnosis of eczema. The intervention group received the ECP and the control group received usual care. Both groups completed a validated eczema severity scale (Patient-Oriented Eczema Measure [POEM]) and a QOL scale (Infant's Dermatitis Quality of Life Index [IDQOL]) or Children's Dermatology Life Quality Index [CDLQI]) before the visit and again ~1 month later. A total of 211 caregivers completed both the pre- and postintervention surveys (100 control group and 111 intervention group [94% completion]). Intervention group providers were more likely to recommend a comprehensive "step-up" plan (88%) vs 28%; P plan to families (80%) vs 2%; P improved between the pre- and postintervention periods. However, there was not a significant difference between the groups on either measure: POEM difference -0.8, 95% confidence interval (CI) -3.2 to 1.7; IDQOL difference -0.1, 95% CI -1.8 to 1.6; CDLQI difference 0.8, 95% CI -0.9 to 2.6. Intervention group providers documented more comprehensive eczema care than control group providers. Although patients improved on all measures in the postintervention period, the ECP did not augment that improvement. Copyright © 2018 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

Science.gov (United States)

Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Zhang-Jin; Chan, Wai-Chi; Zhang, Shi-Ping; Ng, Roger Man-Kin; Chan, Connie Lai-Wah; Ho, Lai-Ming; Yu, Yee-Man; Lao, Li-Xing

2017-03-31

Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. ClinicalTrials.gov NCT02475538 .

Principles and Practices for Quality Assurance and Quality Control

Science.gov (United States)

Jones, Berwyn E.

1999-01-01

Quality assurance and quality control are vital parts of highway runoff water-quality monitoring projects. To be effective, project quality assurance must address all aspects of the project, including project management responsibilities and resources, data quality objectives, sampling and analysis plans, data-collection protocols, data quality-control plans, data-assessment procedures and requirements, and project outputs. Quality control ensures that the data quality objectives are achieved as planned. The historical development and current state of the art of quality assurance and quality control concepts described in this report can be applied to evaluation of data from prior projects.

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

Checking quality control?

DEFF Research Database (Denmark)

Brodersen, Lars

2005-01-01

How is quality control doing within the community of GIS, web-services based on geo-information, GI etc.?......How is quality control doing within the community of GIS, web-services based on geo-information, GI etc.?...

Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

Science.gov (United States)

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2016-01-01

Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

Quality control of gamma radiation measuring systems

International Nuclear Information System (INIS)

Surma, M.J.

2002-01-01

The problem of quality control and assurance of gamma radiation measuring systems has been described in detail. The factors deciding of high quality of radiometric measurements as well as statistical testing and calibration of measuring systems have been presented and discussed

Effects of yoga versus hydrotherapy training on health-related quality of life and exercise capacity in patients with heart failure: A randomized controlled study.

Science.gov (United States)

Hägglund, Ewa; Hagerman, Inger; Dencker, Kerstin; Strömberg, Anna

2017-06-01

The aims of this study were to determine whether yoga and hydrotherapy training had an equal effect on the health-related quality of life in patients with heart failure and to compare the effects on exercise capacity, clinical outcomes, and symptoms of anxiety and depression between and within the two groups. The design was a randomized controlled non-inferiority study. A total of 40 patients, 30% women (mean±SD age 64.9±8.9 years) with heart failure were randomized to an intervention of 12 weeks, either performing yoga or training with hydrotherapy for 45-60 minutes twice a week. Evaluation at baseline and after 12 weeks included self-reported health-related quality of life, a six-minute walk test, a sit-to-stand test, clinical variables, and symptoms of anxiety and depression. Yoga and hydrotherapy had an equal impact on quality of life, exercise capacity, clinical outcomes, and symptoms of anxiety and depression. Within both groups, exercise capacity significantly improved (hydrotherapy p=0.02; yoga p=0.008) and symptoms of anxiety decreased (hydrotherapy p=0.03; yoga p=0.01). Patients in the yoga group significantly improved their health as rated by EQ-VAS ( p=0.004) and disease-specific quality of life in the domains symptom frequency ( p=0.03), self-efficacy ( p=0.01), clinical summary as a combined measure of symptoms and social factors ( p=0.05), and overall summary score ( p=0.04). Symptoms of depression were decreased in this group ( p=0.005). In the hydrotherapy group, lower limb muscle strength improved significantly ( p=0.01). Yoga may be an alternative or complementary option to established forms of exercise training such as hydrotherapy for improvement in health-related quality of life and may decrease depressive symptoms in patients with heart failure.

Randomized Controlled Trial of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Insomnia

Science.gov (United States)

Arnedt, J. Todd; Cuddihy, Leisha; Swanson, Leslie M.; Pickett, Scott; Aikens, James; Chervin, Ronald D.

2013-01-01

Study Objectives: To compare the efficacy of telephone-delivered cognitive-behavioral therapy for insomnia to an information pamphlet control on sleep and daytime functioning at pretreatment, posttreatment, and 12-wk follow-up. Design: Randomized controlled parallel trial. Setting: N/A. Participants: Thirty individuals with chronic insomnia (27 women, age 39.1 ± 14.4 years, insomnia duration 8.7 ± 10.7 years). Interventions: Cognitive behavioral therapy for insomnia (CBTI) delivered in up to eight weekly telephone sessions (CBTI-Phone, n = 15) versus an information pamphlet control (IPC, n = 15). Measurements and Results: Sleep/wake diary, sleep-related questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, 16-item Dysfunctional Beliefs and Attitudes about Sleep), and daytime symptom assessments (fatigue, depression, anxiety, and quality of life) were completed at pretreatment, posttreatment, and 12-wk follow-up. Linear mixed models indicated that sleep/wake diary sleep efficiency and total sleep time improved significantly at posttreatment in both groups and remained stable at 12-wk follow-up. More CBTI-Phone than IPC patients showed posttreatment improvements in unhelpful sleep-related cognitions (P insomnia at follow-up (P insomnia. Future larger-scale studies with more diverse samples are warranted. Some individuals with insomnia may also benefit from pamphlet-delivered CBTI with brief telephone support. Citation: Arnedt JT; Cuddihy L; Swanson LM; Pickett S; Aikens J; Chervin RD. Randomized controlled trial of telephone-delivered cognitive behavioral therapy for chronic insomnia. SLEEP 2013;36(3):353-362. PMID:23450712

A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients.

Science.gov (United States)

Denault, André Y; Bussières, Jean S; Arellano, Ramiro; Finegan, Barry; Gavra, Paul; Haddad, François; Nguyen, Anne Q N; Varin, France; Fortier, Annik; Levesque, Sylvie; Shi, Yanfen; Elmi-Sarabi, Mahsa; Tardif, Jean-Claude; Perrault, Louis P; Lambert, Jean

2016-10-01

Inhaled milrinone (iMil) has been used for the treatment of pulmonary hypertension (PH) but its efficacy, safety, and prophylactic effects in facilitating separation from cardiopulmonary bypass (CPB) and preventing right ventricular (RV) dysfunction have not yet been evaluated in a clinical trial. The purpose of this study was to investigate if iMil administered before CPB would be superior to placebo in facilitating separation from CPB. High-risk cardiac surgical patients with PH were randomized to receive iMil or placebo after the induction of anesthesia and before CPB. Hemodynamic parameters and RV function were evaluated by means of pulmonary artery catheterization and transesophageal echocardiography. The groups were compared for the primary outcome of the level of difficulty in weaning from CPB. Among the secondary outcomes examined were the reduction in the severity of PH, the incidence of RV failure, and mortality. Of the 124 patients randomized, the mean (standard deviation [SD]) EuroSCORE II was 8.0 (2.6), and the baseline mean (SD) systolic pulmonary artery pressure (SPAP) was 53 (9) mmHg. The use of iMil was associated with increases in cardiac output (P = 0.03) and a reduction in SPAP (P = 0.04) with no systemic hypotension. Nevertheless, there was no difference in the combined incidence of difficult or complex separation from CPB between the iMil and control groups (30% vs 28%, respectively; absolute difference, 2%; 95% confidence interval [CI], -14 to 18; P = 0.78). There was also no difference in RV failure between the iMil and control groups (15% vs 14%, respectively; difference, 1%; 95% CI, -13 to 12; P = 0.94). Mortality was increased in patients with RV failure vs those without (22% vs 2%, respectively; P < 0.001). In high-risk cardiac surgery patients with PH, the prophylactic use of iMil was associated with favourable hemodynamic effects that did not translate into improvement of clinically relevant endpoints. This trial was registered at

Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials

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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

Proteomics Quality Control: Quality Control Software for MaxQuant Results.

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Bielow, Chris; Mastrobuoni, Guido; Kempa, Stefan

2016-03-04

Mass spectrometry-based proteomics coupled to liquid chromatography has matured into an automatized, high-throughput technology, producing data on the scale of multiple gigabytes per instrument per day. Consequently, an automated quality control (QC) and quality analysis (QA) capable of detecting measurement bias, verifying consistency, and avoiding propagation of error is paramount for instrument operators and scientists in charge of downstream analysis. We have developed an R-based QC pipeline called Proteomics Quality Control (PTXQC) for bottom-up LC-MS data generated by the MaxQuant software pipeline. PTXQC creates a QC report containing a comprehensive and powerful set of QC metrics, augmented with automated scoring functions. The automated scores are collated to create an overview heatmap at the beginning of the report, giving valuable guidance also to nonspecialists. Our software supports a wide range of experimental designs, including stable isotope labeling by amino acids in cell culture (SILAC), tandem mass tags (TMT), and label-free data. Furthermore, we introduce new metrics to score MaxQuant's Match-between-runs (MBR) functionality by which peptide identifications can be transferred across Raw files based on accurate retention time and m/z. Last but not least, PTXQC is easy to install and use and represents the first QC software capable of processing MaxQuant result tables. PTXQC is freely available at https://github.com/cbielow/PTXQC .

Efficacy of short-term high-dose statin in preventing contrast-induced nephropathy: a meta-analysis of seven randomized controlled trials.

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Yongchuan Li

Full Text Available A few studies focused on statin therapy as specific prophylactic measures of contrast-induced nephropathy have been published with conflicting results. In this meta-analysis of randomized controlled trials, we aimed to assess the effectiveness of short-term high-dose statin treatment for the prevention of CIN and clinical outcomes and re-evaluate of the potential benefits of statin therapy.We searched PubMed, OVID, EMBASE, Web of science and the Cochrane Central Register of Controlled Trials databases for randomized controlled trials comparing short-term high-dose statin treatment versus low-dose statin treatment or placebo for preventing CIN. Our outcome measures were the risk of CIN within 2-5 days after contrast administration and need for dialysis.Seven randomized controlled trials with a total of 1,399 patients were identified and analyzed. The overall results based on fixed-effect model showed that the use of short-term high-dose statin treatment was associated with a significant reduction in risk of CIN (RR =0.51, 95% CI 0.34-0.76, p =0.001; I(2 = 0%. The incidence of acute renal failure requiring dialysis was not significant different after the use of statin (RR = 0.33, 95% CI 0.05-2.10, p = 0.24; I(2 = 0%. The use of statin was not associated with a significant decrease in the plasma C-reactive protein level (SMD -0.64, 95% CI: -1.57 to 0.29, P = 0.18, I(2 = 97%.Although this meta-analysis supports the use of statin to reduce the incidence of CIN, it must be considered in the context of variable patient demographics. Only a limited recommendation can be made in favour of the use of statin based on current data. Considering the limitations of included studies, a large, well designed trial that incorporates the evaluation of clinically relevant outcomes in participants with different underlying risks of CIN is required to more adequately assess the role for statin in CIN prevention.

Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study.

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Huri, Meral; Huri, Emre; Kayihan, Hulya; Altuntas, Onur

2015-08-01

To evaluate the efficiency of occupational therapy relative to a home program in improving quality of life (QoL) among men who were treated for metastatic prostate cancer (MPC). Fifty-five men were assigned randomly to either the 12-week cognitive behavioral therapy based occupational therapy (OT-CBSM) intervention (treatment group) or a home program (control group) between March 2012 and August 2014 in the Department of Occupational Therapy, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey. The Canadian Occupational Performance Measure (COPM) was used to measure the occupational performance and identify difficulties in daily living activities. The QoL and symptom status were measured by The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 and its Prostate Cancer Module. A 12-week OT-CBSM intervention including client-centered training of daily living activities, recreational group activities, and cognitive behavioral stress management intervention were applied. The COPM performance and satisfaction scores, which indicate occupational participation and QoL increased statistically in the treatment group in relation to men who were included in the home-program (p less than or equal to 0.05). A 12-week OT-CBSM intervention was effective in improving QoL in men treated for MPC, and these changes were associated significantly with occupational performance.

Changes in Energy Intake and Diet Quality during an 18-Month Weight-Management Randomized Controlled Trial in Adults with Intellectual and Developmental Disabilities.

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Ptomey, Lauren T; Steger, Felicia L; Lee, Jaehoon; Sullivan, Debra K; Goetz, Jeannine R; Honas, Jeffery J; Washburn, Richard A; Gibson, Cheryl A; Donnelly, Joseph E

2018-06-01

Previous research indicates that individuals with intellectual and developmental disabilities (IDDs) are at risk for poor diet quality. The purpose of this secondary analysis was to determine whether two different weight-loss diets affect energy intake, macronutrient intake, and diet quality as measured by the Healthy Eating Index-2010 (HEI-2010) during a 6-month weight-loss period and 12-month weight-management period, and to examine differences in energy intake, macronutrient intake, and HEI-2010 between groups. Overweight/obese adults with IDDs took part in an 18-month randomized controlled trial and were assigned to either an enhanced Stop Light Diet utilizing portion-controlled meals or a conventional diet consisting of reducing energy intake and following the 2010 Dietary Guidelines for Americans. Proxy-assisted 3-day food records were collected at baseline, 6 months, and 18 months, and were analyzed using Nutrition Data System for Research software. HEI-2010 was calculated using the data from Nutrition Data System for Research. The study took place from June 2011 through May 2014 in the greater Kansas City metropolitan area. This was a secondary analysis of a weight-management intervention for adults with IDDs randomized to an enhanced Stop Light Diet or conventional diet, to examine differences in energy intake, macronutrient intake, and HEI-2010 across time and between groups. Independent- and paired-samples t tests and general mixed modeling for repeated measures were performed to examine group differences and changes at baseline, 6 months, and 18 months between the enhanced Stop Light Diet and conventional diet groups. One hundred and forty six participants (57% female, mean±standard deviation age=36.2±12.0 years) were randomized to either the enhanced Stop Light Diet or conventional diet group (77 enhanced Stop Light Diet, 69 conventional diet) and provided data for analysis at baseline, 124 completed the 6-month weight-loss period, and 101 completed

The results of a quality-control programme in mammography

International Nuclear Information System (INIS)

Ramsdale, M.L.; Hiles, P.A.

1989-01-01

With the introduction of a breast screening programme in the UK, quality assurance in mammography is of paramount importance in assuring optimum imaging performance with low dose. Quality control checks are an essential part of the quality-assurance system. A quality-control programme at a breast screening clinic is described. Daily checks include film sensitometry for X-ray processor control and radiography of a lucite phantom to monitor the consistency of the X-ray machine automatic exposure control. Weekly checks include additional measurements on the performance of the automatic exposure control for different breast thickness and an overall assessment of image quality using a prototype mammography test phantom. The test phantom measures low-contrast sensitivity, high-contrast resolution and small-detail visibility. The results of the quality-control programme are presented with particular attention paid to tolerances and limiting values. (author)

Effects of massage therapy on anxiety, depression, hyperventilation and quality of life in HIV infected patients: A randomized controlled trial.

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Gregory, Reychler; Caty, Gilles; Aude, Arcq; Laurie, Lebrun; Leïla, Belkhir; Jean-Cyr, Yombi; Jean-Christophe, Marot

2017-06-01

HIV infection is often preceded or accompanied by psychiatric comorbidities. These disorders improve with complementary therapies. The aim of this study was to measure the effect of massage therapy on anxiety, depression, hyperventilation and quality of life in HIV infected patients. Adult HIV-infected patients were randomized (n=29) in massage therapy group (one hour a week during four weeks) and control group. Anxiety and depression (HADS-A and HADS-D), hyperventilation (Nijmegen questionnaire) and quality of life (WHOQOL-HIV) were evaluated at inclusion and after 4 weeks. At inclusion, 51% and 17% of the patients had a positive HADS-A and HADS-D score respectively. Two facets from WHOQOL-HIV ("Home environment" and "Death and dying" (p=0.04)) were different between groups. After the four week massage therapy, a significant improvement was observed only for Nijmegen questionnaire (p=0.01) and HADS-A (p=0.04) contrarily to WHOQOL-HIV and HADS-D. Domains of the WHOQOL-HIV did not improve following the massage therapy. Only "Pain and discomfort" facet improved after massage therapy (p=0.04). This study highlights the positive impact of a four week massage therapy on anxiety and hyperventilation in HIV infected patients. However, neither benefit of this program was observed on depression and quality of life. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluating the impact of continuous quality improvement methods at hospitals in Tanzania: a cluster-randomized trial.

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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

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study

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Fiorentino, Lavinia; McQuaid, John R; Liu, Lianqi; Natarajan, Loki; He, Feng; Cornejo, Monique; Lawton, Susan; Parker, Barbara A; Sadler, Georgia R; Ancoli-Israel, Sonia

2010-01-01

Purpose Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I) on sleep in breast cancer survivors. Patients and methods Twenty-one participants were randomly assigned to either a treatment group (six weekly IND-CBT-I sessions followed by six weeks of follow up) or a delayed treatment control group (no treatment for six weeks followed by six weekly IND-CBT-I sessions). Of these, 14 participants completed the pilot study (six in the treatment group and eight in the delayed treatment control group). Results Self-rated insomnia was significantly improved in the treatment group compared to the waiting period in the delayed treatment control group. The pooled pre-post-IND-CBT-I analyses revealed improvements in self-rated insomnia, sleep quality, and objective measures of sleep. Conclusions These preliminary results suggest that IND-CBT-I is appropriate for improving sleep in breast cancer survivors. Individual therapy in a clinic or private practice may be a more practical option for this population as it is more easily accessed and readily available in an outpatient setting. PMID:23616695

Nuevo Amanecer: results of a randomized controlled trial of a community-based, peer-delivered stress management intervention to improve quality of life in Latinas with breast cancer.

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Nápoles, Anna María; Ortíz, Carmen; Santoyo-Olsson, Jasmine; Stewart, Anita L; Gregorich, Steven; Lee, Howard E; Durón, Ysabel; McGuire, Peggy; Luce, Judith

2015-07-01

We evaluated a community-based, translational stress management program to improve health-related quality of life in Spanish-speaking Latinas with breast cancer. We adapted a cognitive-behavioral stress management program integrating evidence-based and community best practices to address the needs of Latinas with breast cancer. Spanish-speaking Latinas with breast cancer were randomly assigned to an intervention or usual-care control group. Trained peers delivered the 8-week intervention between February 2011 and February 2014. Primary outcomes were breast cancer-specific quality of life and distress, and general symptoms of distress. Of 151 participants, 95% were retained at 6 months (between May 2011 and May 2014). Improvements in quality of life from baseline to 6 months were greater for the intervention than the control group on physical well-being, emotional well-being, breast cancer concerns, and overall quality of life. Decreases from baseline to 6 months were greater for the intervention group on depression and somatization. Results suggest that translation of evidence-based programs can reduce psychosocial health disparities in Latinas with breast cancer. Integration of this program into community-based organizations enhances its dissemination potential.

The Reduction of Distress Using Therapeutic Geothermal Water Procedures in a Randomized Controlled Clinical Trial

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Rapolienė, Lolita; Razbadauskas, Artūras; Jurgelėnas, Antanas

2015-01-01

Stress is an element of each human's life and an indicator of its quality. Thermal mineral waters have been used empirically for the treatment of different diseases for centuries. Aim of the Study. To investigate the effects of highly mineralised geothermal water balneotherapy on distress and health risk. Methodology. A randomized controlled clinical trial was performed with 130 seafarers: 65 underwent 2 weeks of balneotherapy with 108 g/L full-mineralisation bath treatment; the others were in control group. The effect of distress was measured using the General Symptoms Distress Scale. Factorial and logistic regression analyses were used for statistical analysis. Results. A significant positive effect on distress (P Balneotherapy with highly mineralised geothermal water reduces distress, by reducing the health risk posed by distress by 26%, increasing the health resources by 11%, and reducing probability of general health risk by 18%. Balneotherapy is an effective preventive tool and can take a significant place in integrative medicine. PMID:25866680

Air-insufflated high-definition dacryoendoscopy yields significantly better image quality than conventional dacryoendoscopy

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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

Completion report : Effect of Comprehensive Yogic Breathing program on type 2 diabetes: A randomized control trial

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V P Jyotsna

2014-01-01

Full Text Available Background: Yoga has been shown to be benefi cial in diabetes in many studies, though randomized control trials are few. The aim of this randomized control trial was to see the effect of Sudarshan Kriya and related practices (comprehensive yogic breathing program on quality of life, glycemic control, and cardiac autonomic functions in diabetes. Diabetes mellitus is a risk factor for sudden cardiac death. Cardiac autonomic neuropathy has been implicated in the causation of sudden cardiac death. Therefore, a maneuver to prevent progression of cardiac autonomic neuropathy holds signifi cance. Materials and Methods: A total of 120 patients of diabetes on oral medication and diet and exercise advice were randomized into two groups: (1 Continued to receive standard treatment for diabetes. (2 Patients administered comprehensive yogic breathing program and monitored to regularly practice yoga in addition to standard treatment of diabetes. At 6 months, quality of life and postprandial plasma glucose signifi cantly improved in the group practicing yoga compared to baseline, but there was no significant improvement in the fasting plasma glucose and glycated hemoglobin. Results: On per protocol analysis, sympathetic cardiac autonomic functions signifi cantly improved from baseline in the group practicing comprehensive yogic breathing. Conclusion: This randomized control trial points towards the beneficial effect of yogic breathing program in preventing progression of cardiac neuropathy. This has important implications as cardiac autonomic neuropathy has been considered as one of the factors for sudden cardiac deaths.Keywords: comprehensive yogic breathing program, diabetes mellitus, cardiac autonomic function

Independent and Social Living Skills Training for People with Schizophrenia in Iran: a Randomized Controlled Trial

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Ashraf Karbalaee-Nouri

2015-09-01

Full Text Available Objectives: Schizophrenia is responsible for a significant proportion of burden of mental diseases in Iran. Lack of a follow-up system has resulted in the repeated hospitalizations. In this study it is hypothesized that standardized living skills training delivered to participants with schizophrenia in outpatient and inpatient centers can be effective compared to a  control group (with occupational therapy in reducing psychopathology severity and increasing quality of life. Methods: This is a multi-centered parallel group randomized controlled trial in Iran and it is single-blinded. Eligible participants are randomly allocated into two groups in a 1:1 ratio. Participants are assigned by stratified balanced block randomization method. The trial is conducted in the cities of Tehran and Mashhad. Its aim is to recruit 160 clients with schizophrenia. The intervention for the experimental group is social living skills training. The intervention for the control group is occupational therapy. The intervention for both groups is conducted in 90 to 120-minute group sessions. Results: The primary outcome of the study would be a decrease in  psychopathology severity, an improvement in participants' quality of life, and reduction in family burden will be followed for 6 months. Discussion: This paper presents a protocol for a randomized controlled trial of independent and social living skills training intervention delivered to participants with schizophrenia. If this intervention is effective, it could be scaled up to be developing for policymaking and improving outcomes for schizophrenic participants and their families in Iran.

HPLC for quality control of polyimides

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Young, P. R.; Sykes, G. F.

1979-01-01

High Pressure Liquid Chromatography (HPLC) as a quality control tool for polyimide resins and prepregs are presented. A data base to help establish accept/reject criteria for these materials was developed. This work is intended to supplement, not replace, standard quality control tests normally conducted on incoming resins and prepregs. To help achieve these objectives, the HPLC separation of LARC-160 polyimide precursor resin was characterized. Room temperature resin aging effects were studied. Graphite reinforced composites made from fresh and aged resin were fabricated and tested to determine if changes observed by HPLC were significant.

Massage Therapy for Pain and Function in Patients With Arthritis: A Systematic Review of Randomized Controlled Trials.

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Nelson, Nicole L; Churilla, James R

2017-09-01

Massage therapy is gaining interest as a therapeutic approach to managing osteoarthritis and rheumatoid arthritis symptoms. To date, there have been no systematic reviews investigating the effects of massage therapy on these conditions. Systematic review was used. The primary aim of this review was to critically appraise and synthesize the current evidence regarding the effects of massage therapy as a stand-alone treatment on pain and functional outcomes among those with osteoarthritis or rheumatoid arthritis. Relevant randomized controlled trials were searched using the electronic databases Google Scholar, MEDLINE, and PEDro. The PEDro scale was used to assess risk of bias, and the quality of evidence was assessed with the GRADE approach. This review found seven randomized controlled trials representing 352 participants who satisfied the inclusion criteria. Risk of bias ranged from four to seven. Our results found low- to moderate-quality evidence that massage therapy is superior to nonactive therapies in reducing pain and improving certain functional outcomes. It is unclear whether massage therapy is more effective than other forms of treatment. There is a need for large, methodologically rigorous randomized controlled trials investigating the effectiveness of massage therapy as an intervention for individuals with arthritis.

Automatic quality control in clinical (1)H MRSI of brain cancer.

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Pedrosa de Barros, Nuno; McKinley, Richard; Knecht, Urspeter; Wiest, Roland; Slotboom, Johannes

2016-05-01

MRSI grids frequently show spectra with poor quality, mainly because of the high sensitivity of MRS to field inhomogeneities. These poor quality spectra are prone to quantification and/or interpretation errors that can have a significant impact on the clinical use of spectroscopic data. Therefore, quality control of the spectra should always precede their clinical use. When performed manually, quality assessment of MRSI spectra is not only a tedious and time-consuming task, but is also affected by human subjectivity. Consequently, automatic, fast and reliable methods for spectral quality assessment are of utmost interest. In this article, we present a new random forest-based method for automatic quality assessment of (1)H MRSI brain spectra, which uses a new set of MRS signal features. The random forest classifier was trained on spectra from 40 MRSI grids that were classified as acceptable or non-acceptable by two expert spectroscopists. To account for the effects of intra-rater reliability, each spectrum was rated for quality three times by each rater. The automatic method classified these spectra with an area under the curve (AUC) of 0.976. Furthermore, in the subset of spectra containing only the cases that were classified every time in the same way by the spectroscopists, an AUC of 0.998 was obtained. Feature importance for the classification was also evaluated. Frequency domain skewness and kurtosis, as well as time domain signal-to-noise ratios (SNRs) in the ranges 50-75 ms and 75-100 ms, were the most important features. Given that the method is able to assess a whole MRSI grid faster than a spectroscopist (approximately 3 s versus approximately 3 min), and without loss of accuracy (agreement between classifier trained with just one session and any of the other labelling sessions, 89.88%; agreement between any two labelling sessions, 89.03%), the authors suggest its implementation in the clinical routine. The method presented in this article was implemented

Dietary weight loss and exercise interventions effects on quality of life in overweight/obese postmenopausal women: a randomized controlled trial

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Wang Ching-Yun

2011-10-01

Full Text Available Abstract Background Although lifestyle interventions targeting multiple lifestyle behaviors are more effective in preventing unhealthy weight gain and chronic diseases than intervening on a single behavior, few studies have compared individual and combined effects of diet and/or exercise interventions on health-related quality of life (HRQOL. In addition, the mechanisms of how these lifestyle interventions affect HRQOL are unknown. The primary aim of this study was to examine the individual and combined effects of dietary weight loss and/or exercise interventions on HRQOL and psychosocial factors (depression, anxiety, stress, social support. The secondary aim was to investigate predictors of changes in HRQOL. Methods This study was a randomized controlled trial. Overweight/obese postmenopausal women were randomly assigned to 12 months of dietary weight loss (n = 118, moderate-to-vigorous aerobic exercise (225 minutes/week, n = 117, combined diet and exercise (n = 117, or control (n = 87. Demographic, health and anthropometric information, aerobic fitness, HRQOL (SF-36, stress (Perceived Stress Scale, depression [Brief Symptom Inventory (BSI-18], anxiety (BSI-18 and social support (Medical Outcome Study Social Support Survey were assessed at baseline and 12 months. The 12-month changes in HRQOL and psychosocial factors were compared using analysis of covariance, adjusting for baseline scores. Multiple regression was used to assess predictors of changes in HRQOL. Results Twelve-month changes in HRQOL and psychosocial factors differed by intervention group. The combined diet + exercise group improved 4 aspects of HRQOL (physical functioning, role-physical, vitality, and mental health, and stress (p ≤ 0.01 vs. controls. The diet group increased vitality score (p Conclusions A combined diet and exercise intervention has positive effects on HRQOL and psychological health, which may be greater than that from exercise or diet alone. Improvements in

Investigating the effect of a 3-month workplace-based pedometer-driven walking programme on health-related quality of life in meat processing workers: a feasibility study within a randomized controlled trial.

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Mansi, Suliman; Milosavljevic, Stephan; Tumilty, Steve; Hendrick, Paul; Higgs, Chris; Baxter, David G

2015-04-22

In New Zealand, meat processing populations face many health problems as a result of the nature of work in meat processing industries. The primary aim of this study was to examine the feasibility of using a pedometer-based intervention to increase physical activity and improve health-related outcomes in a population of meat processing workers. A single-blinded randomized controlled trial (RCT) was conducted. A convenience sample of meat workers (n = 58; mean age 41.0 years; range: 18-65) participated in the trial. Participants were randomly allocated into two groups. Intervention participants (n = 29) utilized a pedometer to self monitor their activity, whilst undertaking a brief intervention, and educational material. Control participants (n = 29) received educational material only. The primary outcomes of ambulatory activity, and health-related quality of life, were evaluated at baseline, immediately following the 12-week intervention and three months post-intervention. Fifty three participants completed the program (91.3% adherence). Adherence with the intervention group was high, 93% (n = 27/29), and this group increased their mean daily step count from 5993 to 9792 steps per day, while the control group steps changed from 5788 to 6551 steps per day from baseline. This increase in step counts remained significant within the intervention group p workplace setting over the short term. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000087752.

Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review.

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Isabelle Boutron

2006-10-01

Full Text Available BACKGROUND: Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments. METHODS AND FINDINGS: We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1 established blinding of patients or health care providers, (2 maintained the blinding of patients or health care providers, and (3 obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58% describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage, or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or

The results of a quality-control programme in mammography

International Nuclear Information System (INIS)

Ramsdale, M.L.; Hiles, P.A.

1989-01-01

A quality-control programme at a breast screening clinic is described. Daily checks include film sensitometry for X-ray processor control and radiography of a lucite phantom to monitor the consistency of the X-ray machine automatic exposure control. Weekly checks include additional measurements on the performance of the automatic exposure control for different breast thickness and an overall assessment of image quality using a prototype mammography test phantom. The test phantom measures low-contrast sensitivity, high-control resolution and small-detail visibility. The results of the quality-control programme are presented with particular attention paid to tolerances and limiting values. (author)

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.

Quality control of intelligence research

International Nuclear Information System (INIS)

Lu Yan; Xin Pingping; Wu Jian

2014-01-01

Quality control of intelligence research is the core issue of intelligence management, is a problem in study of information science This paper focuses on the performance of intelligence to explain the significance of intelligence research quality control. In summing up the results of the study on the basis of the analysis, discusses quality control methods in intelligence research, introduces the experience of foreign intelligence research quality control, proposes some recommendations to improve quality control in intelligence research. (authors)

A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study

DEFF Research Database (Denmark)

Jensen, Janet F.; Egerod, Ingrid; Bestle, Morten H.

2016-01-01

and December 2015, at ten intensive care units (ICUs) in Denmark. We randomly assigned 386 adult patients (≥18 years) after receiving mechanical ventilation (≥48 h) to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC......Purpose: The aim of this randomized controlled trial (RCT) was to test the effectiveness of a post-ICU recovery program compared to standard care during the first year after ICU discharge. Methods: A pragmatic, non-blinded, multicenter, parallel-group RCT was conducted between December 2012......). Primary outcome was health-related quality of life (HRQOL) at 12 months. Secondary outcomes were sense of coherence (SOC), anxiety, depression, and posttraumatic stress disorder (PTSD) assessed at 3 and 12 months after ICU discharge including utilization of healthcare services at 12 months. Results: At 12...

Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial

OpenAIRE

Mannerkorpi, Kaisa; Nordeman, Lena; Cider, ?sa; Jonsson, Gunilla

2010-01-01

Introduction The objective of this study was to investigate the effects of moderate-to-high intensity Nordic walking (NW) on functional capacity and pain in fibromyalgia (FM). Methods A total of 67 women with FM were recruited to the study and randomized either to moderate-to-high intensity Nordic Walking (n = 34, age 48 ? 7.8 years) or to a control group engaging in supervised low-intensity walking (LIW, n = 33, age 50 ? 7.6 years). Primary outcomes were the six-minute walk test (6MWT) and t...

Interaction between production control and quality control

NARCIS (Netherlands)

Bij, van der J.D.; Ekert, van J.H.W.

1999-01-01

Describes a qualitative study on interaction between systems for production control and quality control within industrial organisations. Production control and quality control interact in a sense. Good performance for one aspect often influences or frustrates the performance of the other. As far as

Quality control in radiotherapy

International Nuclear Information System (INIS)

Batalla, A.

2009-01-01

The authors discuss the modalities and periodicities of internal quality control on radiotherapy installations. They indicate the different concerned systems and the aspects and items to be controlled (patient and personnel security, apparatus mechanical characteristics, beam quality, image quality, isodose and irradiation duration calculation, data transfer). They present the measurement instruments and tools used for the mechanical controls, dose measurement, beam homogeneity and symmetry, anatomic data acquisition systems, and dose distribution and control imagery calculation

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.

Can Team-Based Care Improve Patient Satisfaction? A Systematic Review of Randomized Controlled Trials

Science.gov (United States)

Wen, Jin; Schulman, Kevin A.

2014-01-01

Background Team-based approaches to patient care are a relatively recent innovation in health care delivery. The effectiveness of these approaches on patient outcomes has not been well documented. This paper reports a systematic review of the relationship between team-based care and patient satisfaction. Methods We searched MEDLINE, EMBASE, Cochrane Library, CINAHL, and PSYCHOINFO for eligible studies dating from inception to October 8, 2012. Eligible studies reported (1) a randomized controlled trial, (2) interventions including both team-based care and non-team-based care (or usual care), and (3) outcomes including an assessment of patient satisfaction. Articles with different settings between intervention and control were excluded, as were trial protocols. The reference lists of retrieved papers were also evaluated for inclusion. Results The literature search yielded 319 citations, of which 77 were screened for further full-text evaluation. Of these, 27 articles were included in the systematic review. The 26 trials with a total of 15,526 participants were included in this systematic review. The pooling result of dichotomous data (number of studies: 10) showed that team-based care had a positive effect on patient satisfaction compared with usual care (odds ratio, 2.09; 95% confidence interval, 1.54 to 2.84); however, combined continuous data (number of studies: 7) demonstrated that there was no significant difference in patient satisfaction between team-based care and usual care (standardized mean difference, −0.02; 95% confidence interval, −0.40 to 0.36). Conclusions Some evidence showed that team-based care is better than usual care in improving patient satisfaction. However, considering the pooling result of continuous data, along with the suboptimal quality of included trials, further large-scale and high-quality randomized controlled trials comparing team-based care and usual care are needed. PMID:25014674

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

Mindfulness-based stress reduction for residents: A randomized controlled trial

NARCIS (Netherlands)

Verweij, H.; Ravesteijn, H.J. van; Hooff, M.L.M. van; Lagro-Janssen, A.L.M.; Speckens, A.E.M.

2018-01-01

Background: Burnout is highly prevalent in residents. No randomized controlled trials have been conducted measuring the effects of Mindfulness-Based Stress Reduction (MBSR) on burnout in residents. Objective: To determine the effectiveness of MBSR in reducing burnout in residents. Design: A

Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial.

Science.gov (United States)

Visscher, Arjan P; Lam, Tze J; Meurs-Szojda, Maria M; Felt-Bersma, Richelle J F

2017-08-01

Controlled delivery of radiofrequency energy has been suggested as treatment for fecal incontinence. The aim of this study was to determine whether the clinical response to the radiofrequency energy procedure is superior to sham in patients with fecal incontinence. This was a randomized sham-controlled clinical trial from 2008 to 2015. This study was conducted in an outpatient clinic. Forty patients with fecal incontinence in whom maximal conservative management had failed were randomly assigned to receiving either radiofrequency energy or sham procedure. Fecal incontinence was measured using the Vaizey incontinence score (range, 0-24). The impact of fecal incontinence on quality of life was measured by using the fecal incontinence quality-of-life score (range, 1-4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the radiofrequency energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The fecal incontinence quality-of-life score at t = 6 months was not statistically different. Anorectal function did not show any alteration. Patients with severe fecal incontinence were included in the study, thus making it difficult to generalize the results. Both radiofrequency energy and sham procedure improved the fecal incontinence score, the radiofrequency energy procedure more than sham. Although statistically significant, the clinical impact for most of the patients was negligible. Therefore, the radiofrequency energy procedure should not be recommended for patients with fecal incontinence until patient-related factors associated with treatment success are known. See Video Abstract at http://links.lww.com/DCR/A373.

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.

A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

Science.gov (United States)

Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

2014-05-24

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

Controllable Edge Oxidation and Bubbling Exfoliation Enable the Fabrication of High Quality Water Dispersible Graphene.

Science.gov (United States)

Tian, Suyun; Sun, Jing; Yang, Siwei; He, Peng; Wang, Gang; Di, Zengfeng; Ding, Guqiao; Xie, Xiaoming; Jiang, Mianheng

2016-09-26

Despite significant progresses made on mass production of chemically exfoliated graphene, the quality, cost and environmental friendliness remain major challenges for its market penetration. Here, we present a fast and green exfoliation strategy for large scale production of high quality water dispersible few layer graphene through a controllable edge oxidation and localized gas bubbling process. Mild edge oxidation guarantees that the pristine sp 2 lattice is largely intact and the edges are functionalized with hydrophilic groups, giving rise to high conductivity and good water dispersibility at the same time. The aqueous concentration can be as high as 5.0 mg mL -1 , which is an order of magnitude higher than previously reports. The water soluble graphene can be directly spray-coated on various substrates, and the back-gated field effect transistor give hole and electron mobility of ~496 and ~676 cm 2 V -1 s -1 , respectively. These results achieved are expected to expedite various applications of graphene.

Controllable Edge Oxidation and Bubbling Exfoliation Enable the Fabrication of High Quality Water Dispersible Graphene

Science.gov (United States)

Tian, Suyun; Sun, Jing; Yang, Siwei; He, Peng; Wang, Gang; di, Zengfeng; Ding, Guqiao; Xie, Xiaoming; Jiang, Mianheng

2016-09-01

Despite significant progresses made on mass production of chemically exfoliated graphene, the quality, cost and environmental friendliness remain major challenges for its market penetration. Here, we present a fast and green exfoliation strategy for large scale production of high quality water dispersible few layer graphene through a controllable edge oxidation and localized gas bubbling process. Mild edge oxidation guarantees that the pristine sp2 lattice is largely intact and the edges are functionalized with hydrophilic groups, giving rise to high conductivity and good water dispersibility at the same time. The aqueous concentration can be as high as 5.0 mg mL-1, which is an order of magnitude higher than previously reports. The water soluble graphene can be directly spray-coated on various substrates, and the back-gated field effect transistor give hole and electron mobility of ~496 and ~676 cm2 V-1 s-1, respectively. These results achieved are expected to expedite various applications of graphene.

Effectiveness of acupuncture therapy as treatment for tinnitus: a randomized controlled trial

Directory of Open Access Journals (Sweden)

Marcelo Yugi Doi

Full Text Available ABSTRACT INTRODUCTION: Tinnitus is a subjective sensation of hearing a sound in the absence of an external stimulus, which significantly worsens the quality of life in 15-25% of affected individuals. OBJECTIVE: To assess the effectiveness of acupuncture therapy for tinnitus. METHODS: Randomized clinical trial (REBEC: 2T9T7Q with 50 participants with tinnitus, divided into two groups: 25 participants in the acupuncture group and 25 participants in the control group. The acupuncture group received acupuncture treatment and the control group received no treatment. After a period of 5 weeks, they were called to perform the final evaluation and the control group received acupuncture treatment for ethical reasons. RESULTS: A statistically significant result was found for the primary outcome, reducing the intensity of tinnitus, with p = 0.0001 and the secondary endpoint, showing improvement in quality of life, with p = 0.0001. CONCLUSION: Chinese scalp acupuncture associated with bilateral electroacupuncture demonstrated, in the short term, a statistically significant improvement by reducing the level of tinnitus intensity, as well as improving the quality of life of individuals with tinnitus.

Effectiveness of acupuncture therapy as treatment for tinnitus: a randomized controlled trial.

Science.gov (United States)

Doi, Marcelo Yugi; Tano, Simone Sayomi; Schultz, Adriane Rocha; Borges, Ricardo; Marchiori, Luciana Lozza de Moraes

2016-01-01

Tinnitus is a subjective sensation of hearing a sound in the absence of an external stimulus, which significantly worsens the quality of life in 15-25% of affected individuals. To assess the effectiveness of acupuncture therapy for tinnitus. Randomized clinical trial ( 2T9T7Q) with 50 participants with tinnitus, divided into two groups: 25 participants in the acupuncture group and 25 participants in the control group. The acupuncture group received acupuncture treatment and the control group received no treatment. After a period of 5 weeks, they were called to perform the final evaluation and the control group received acupuncture treatment for ethical reasons. A statistically significant result was found for the primary outcome, reducing the intensity of tinnitus, with p=0.0001 and the secondary endpoint, showing improvement in quality of life, with p=0.0001. Chinese scalp acupuncture associated with bilateral electroacupuncture demonstrated, in the short term, a statistically significant improvement by reducing the level of tinnitus intensity, as well as improving the quality of life of individuals with tinnitus. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Spiritual therapy to improve the spiritual well-being of Iranian women with breast cancer: a randomized controlled trial.

Science.gov (United States)

Jafari, Najmeh; Farajzadegan, Ziba; Zamani, Ahmadreza; Bahrami, Fatemeh; Emami, Hamid; Loghmani, Amir; Jafari, Nooshin

2013-01-01

Purpose. The aim of this study was to investigate the role of spiritual therapy intervention in improving the spiritual well-being and quality of life (QOL) of Iranian women with breast cancer. Methods. This randomized controlled clinical trial (RCT) recruited 65 women with breast cancer, randomly assigned to a 6-week spirituality-based intervention (n = 34) or control group (n = 31). Before and after six-week spiritual therapy intervention, spiritual well-being and quality of life (QOL) were assessed using Functional Assessment of Chronic Illness Therapy Spiritual Well-being scale (FACIT-Sp12) and cancer quality-of-life questionnaire (QLQ-C30), respectively. t-test, Paired t-test, pearson's correlation, and hierarchical regression analyses were used for analysis using Predictive Analytic software (PASW, version 18) for Windows. Results. After six spiritual therapy sessions, the mean spiritual well-being score from 29.76 (SD = 6.63) to 37.24 (SD = 3.52) in the intervention group (P spiritual well-being and overall QOL. Social functioning was another significant predictor of spiritual well-being. Conclusion. The results of this randomized controlled trial study suggest that participation in spiritual therapy program is associated with improvements in spiritual well-being and QOL. Targeted interventions to acknowledge and incorporate spiritual needs into conventional treatment should be considered in caring of Iranian patients with breast cancer.

Compression Stockings after Endovenous Laser Ablation of the Great Saphenous Vein : A Prospective Randomized Controlled Trial

NARCIS (Netherlands)

Bakker, N. A.; Schieven, L. W.; Bruins, R. M. G.; van den Berg, M.; Hissink, R. J.

2013-01-01

Objectives: To determine if the duration of wearing compression stockings after endovenous laser ablation (EVLA) of the great saphenous vein (GSV) has influence on pain and quality of life. Methods: This was a prospective randomized controlled trial. Between December 2006 and February 2008, 109

Quality control in paediatric nuclear medicine

International Nuclear Information System (INIS)

Fischer, S.; Hahn, K.

1997-01-01

Nuclear medicine examinations in children require a maximum in quality. This is true for the preparation of the child and parents, the imaging procedure, processing and documentation. It is necessary that quality control through all steps is performed regularly. The aim must be that the children receive a minimum radiation dose, while there needs to be a high quality in imaging and clinical information from the study. Furthermore the child should not be too much psychologically affected by the nuclear medicine examination. (orig.) [de

Effectiveness of a Behavior Change Program on Physical Activity and Eating Habits in Patients With Hypertension: A Randomized Controlled Trial.

Science.gov (United States)

Gerage, Aline Mendes; Benedetti, Tânia Rosane Bertoldo; Ritti-Dias, Raphael Mendes; Dos Santos, Ana Célia Oliveira; de Souza, Bruna Cadengue Coêlho; Almeida, Fábio Araujo

2017-12-01

This study aimed to analyze the effect of a behavior change program, called Vida Ativa Melhorando a Saúde (VAMOS), on physical activity, eating habits, and quality of life in patients with hypertension. A randomized controlled trial was carried out in 90 patients with hypertension (57.8 ± 9.9 y). They were randomly assigned to 2 groups: VAMOS group (n = 45) and control group (n = 45). The VAMOS group participated in a behavioral change program aimed at motivating changes in physical activity and nutrition behavior for 12 weeks. Physical activity, eating habits, quality of life, self-efficacy, and social support were evaluated at preintervention and postintervention. The control group increased sedentary time (407 ± 87 vs 303 ± 100 min/d; P healthy eating habits score (36.9 ± 6.6 vs 43.4 ± 5.8; P eating habits and quality of life in patients with hypertension.

Quality control and analysis of radiotracer compounds

International Nuclear Information System (INIS)

Sheppard, G.; Thomson, R.

1977-01-01

Special emphasis was on the problems and errors possible in quality control and analysis. The principles underlying quality control were outlined, and analytical techniques applicable to radiotracers were described. Chapter concluded with a selection of examples showing the effects of impurities on the use of radiotracers. The subject of quality control and analysis was treated from the viewpoint of the user and those research workers who need to synthesize and analyze their own radiochemicals. The quality characteristics for radiotracers are of two kinds, valuable or attributive. These were discussed in the chapter. For counting low radioactive concentration, scintillation techniques are in general use, whereas ionization techniques are now used mainly for the measurement of high radioactive concentrations or large quantities of radioactivity, for scanning chromatograms, and a number of very specific purposes. Determination of radionuclidic purity was discussed. Use of radiotracers in pharmaceuticals were presented. 4 figures, 6 tables

High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial.

Science.gov (United States)

Levinger, Pazit; Dunn, Jeremy; Bifera, Nancy; Butson, Michael; Elias, George; Hill, Keith D

2017-08-18

The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined. This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA. The results of this study will improve understanding

Pregabalin for anxiety in patients with schizophrenia - A randomized, double-blind placebo-controlled study

DEFF Research Database (Denmark)

Schjerning, Ole; Damkier, Per; Lykkegaard, Signe Engelhardt

2017-01-01

INTRODUCTION: Anxiety is frequent in patients with schizophrenia and poses a major impact on patients perceived quality of life, daily functioning and risk of suicide. Pregabalin has shown effective in the treatment of generalized anxiety disorder and has been suggested for the treatment of anxiety...... in patients with schizophrenia. As evidence is sparse regarding treatment of anxiety in this patient group, we aimed to investigate the use of pregabalin for anxiety in patients with schizophrenia. METHODS: A randomized, double-blind placebo controlled study was used. Patients were randomized to either...... placebo or pregabalin (≤600mg/d) as add-on treatment. Primary analyses were intention-to-treat based with change in Hamilton Anxiety Scale after 4 and 8weeks of treatment as primary outcome. Secondary outcomes were change in psychopathology, quality-of-life, cognitive functioning and sleep. The study used...

Automated daily quality control analysis for mammography in a multi-unit imaging center.

Science.gov (United States)

Sundell, Veli-Matti; Mäkelä, Teemu; Meaney, Alexander; Kaasalainen, Touko; Savolainen, Sauli

2018-01-01

Background The high requirements for mammography image quality necessitate a systematic quality assurance process. Digital imaging allows automation of the image quality analysis, which can potentially improve repeatability and objectivity compared to a visual evaluation made by the users. Purpose To develop an automatic image quality analysis software for daily mammography quality control in a multi-unit imaging center. Material and Methods An automated image quality analysis software using the discrete wavelet transform and multiresolution analysis was developed for the American College of Radiology accreditation phantom. The software was validated by analyzing 60 randomly selected phantom images from six mammography systems and 20 phantom images with different dose levels from one mammography system. The results were compared to a visual analysis made by four reviewers. Additionally, long-term image quality trends of a full-field digital mammography system and a computed radiography mammography system were investigated. Results The automated software produced feature detection levels comparable to visual analysis. The agreement was good in the case of fibers, while the software detected somewhat more microcalcifications and characteristic masses. Long-term follow-up via a quality assurance web portal demonstrated the feasibility of using the software for monitoring the performance of mammography systems in a multi-unit imaging center. Conclusion Automated image quality analysis enables monitoring the performance of digital mammography systems in an efficient, centralized manner.

Autoshaping, random control, and omission training in the rat.

Science.gov (United States)

Locurto, C; Terrace, H S; Gibbon, J

1976-11-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

Very high performance pseudo-random number generation on DAP

Science.gov (United States)

Smith, K. A.; Reddaway, S. F.; Scott, D. M.

1985-07-01

Since the National DAP Service began at QMC in 1980, extensive use has been made of pseudo-random numbers in Monte Carlo simulation. Matrices of uniform numbers have been produced by various generators: (a) multiplicative ( x+ 1 = 13 13xn mod 2 59); (b) very long period shift register ( x4423 + x271 + 1); (c) multiple shorter period ( x127 + x7 + 1) shift registers generating several matrices per iteration. The above uniform generators can also feed a normal distribution generator that uses the Box-Muller transformation. This paper describes briefly the generators, their implementation and speed. Generator (b) has been greatly speeded-up by re-implementation, and now produces more than 100 × 10 6 high quality 16-bit numbers/s. Generator (c) is under development and will achieve even higher performance, mainly due to producing data in greater bulk. High quality numbers are expected, and performance will range from 400 to 800 × 10 6 numbers/s, depending on how the generator is used.

Can a combination of average of normals and "real time" External Quality Assurance replace Internal Quality Control?

Science.gov (United States)

Badrick, Tony; Graham, Peter

2018-03-28

Internal Quality Control and External Quality Assurance are separate but related processes that have developed independently in laboratory medicine over many years. They have different sample frequencies, statistical interpretations and immediacy. Both processes have evolved absorbing new understandings of the concept of laboratory error, sample material matrix and assay capability. However, we do not believe at the coalface that either process has led to much improvement in patient outcomes recently. It is the increasing reliability and automation of analytical platforms along with improved stability of reagents that has reduced systematic and random error, which in turn has minimised the risk of running less frequent IQC. We suggest that it is time to rethink the role of both these processes and unite them into a single approach using an Average of Normals model supported by more frequent External Quality Assurance samples. This new paradigm may lead to less confusion for laboratory staff and quicker responses to and identification of out of control situations.

Severe negative energy balance during 21 d at high altitude decreases fat-free mass regardless of dietary protein intake: a randomized controlled trial.

Science.gov (United States)

Berryman, Claire E; Young, Andrew J; Karl, J Philip; Kenefick, Robert W; Margolis, Lee M; Cole, Renee E; Carbone, John W; Lieberman, Harris R; Kim, Il-Young; Ferrando, Arny A; Pasiakos, Stefan M

2018-02-01

In this 2-phase randomized controlled study, we examined whether consuming a higher-protein (HP) diet would attenuate fat-free mass (FFM) loss during energy deficit (ED) at high altitude (HA) in 17 healthy males (mean ± sd: 23 ± 6 yr; 82 ± 14 kg). During phase 1 at sea level (SL, 55 m), participants consumed a eucaloric diet providing standard protein (SP; 1.0 g protein/kg,) for 21 d. During phase 2, participants resided at HA (4300 m) for 22 d and were randomly assigned to either an SP or HP (2.0 g protein/kg) diet designed to elicit a 40% ED. Body composition, substrate oxidation, and postabsorptive whole-body protein kinetics were measured. Participants were weight stable during SL and lost 7.9 ± 1.9 kg ( P Berryman, C. E., Young, A. J., Karl, J. P., Kenefick, R. W., Margolis, L. M., Cole, R. E., Carbone, J. W., Lieberman, H. R., Kim, I.-Y., Ferrando, A. A., Pasiakos, S. M. Severe negative energy balance during 21 d at high altitude decreases fat-free mass regardless of dietary protein intake: a randomized controlled trial.

A randomized controlled trial of laser treatment among hirsute women with polycystic ovary syndrome.

Science.gov (United States)

Clayton, W J; Lipton, M; Elford, J; Rustin, M; Sherr, L

2005-05-01

Facial hirsutism is one of the characteristic features of polycystic ovary syndrome (PCOS), and this can lead to high levels of depression and anxiety. To evaluate the impact of laser treatment on the severity of facial hirsutism and on psychological morbidity in women with PCOS. A randomized controlled trial of five high-fluence treatments (intervention) vs. five low-fluence treatments (control) was performed over 6 months in a National Health Service teaching hospital. Subjects were 88 women with facial hirsutism due to PCOS recruited from hospital outpatient clinics and a patient support group in 2001-2002. The main outcomes were self-reported severity of facial hair (measured on a scale of 1-10), depression, anxiety (measured on the Hospital Anxiety and Depression Scale) and quality of life (measured on the WHOQOL-BREF). Self-reported severity of facial hair in the intervention group (n = 51) fell from 7.3 to 3.6 over the 6-month study period; for the control group (n = 37) the corresponding scores were 7.1 and 6.1. The change was significantly greater in the intervention group [ancova F((1,83)) = 24.5, P hair removal declined from 112 to 21 min per week in the intervention group and from 92 to 56 min in the control group [F((1,80)) = 10.2, P Psychological quality of life also improved more in the intervention group, from 49.6 to 61.2 vs. 50.1 to 51.5 in the control group [F((1,84)) = 10.9, P facial hair and time spent on hair removal as well as alleviating depression and anxiety in women with PCOS. These findings suggest that ways of making this method of hair removal more widely available to women with facial hirsutism should be considered.

Smart light random memory sprays Retinex: a fast Retinex implementation for high-quality brightness adjustment and color correction.

Science.gov (United States)

Banić, Nikola; Lončarić, Sven

2015-11-01

Removing the influence of illumination on image colors and adjusting the brightness across the scene are important image enhancement problems. This is achieved by applying adequate color constancy and brightness adjustment methods. One of the earliest models to deal with both of these problems was the Retinex theory. Some of the Retinex implementations tend to give high-quality results by performing local operations, but they are computationally relatively slow. One of the recent Retinex implementations is light random sprays Retinex (LRSR). In this paper, a new method is proposed for brightness adjustment and color correction that overcomes the main disadvantages of LRSR. There are three main contributions of this paper. First, a concept of memory sprays is proposed to reduce the number of LRSR's per-pixel operations to a constant regardless of the parameter values, thereby enabling a fast Retinex-based local image enhancement. Second, an effective remapping of image intensities is proposed that results in significantly higher quality. Third, the problem of LRSR's halo effect is significantly reduced by using an alternative illumination processing method. The proposed method enables a fast Retinex-based image enhancement by processing Retinex paths in a constant number of steps regardless of the path size. Due to the halo effect removal and remapping of the resulting intensities, the method outperforms many of the well-known image enhancement methods in terms of resulting image quality. The results are presented and discussed. It is shown that the proposed method outperforms most of the tested methods in terms of image brightness adjustment, color correction, and computational speed.

Effects of Exergames on Quality of Life, Pain, and Disease Effect in Women With Fibromyalgia: A Randomized Controlled Trial.

Science.gov (United States)

Collado-Mateo, Daniel; Dominguez-Muñoz, Francisco Javier; Adsuar, Jose Carmelo; Garcia-Gordillo, Miguel Angel; Gusi, Narcis

2017-09-01

To evaluate the effects of an exergame-based intervention on a population sample of women with fibromyalgia. Single-blinded, randomized controlled trial with 8-week intervention. Fibromyalgia center. Participants (all women) (N=83) were divided into 2 groups: an exercise group (n=42; mean age ± SD, 52.52±9.73y) and a nonexercise group (n=41; mean age ± SD, 52.47±8.75y). Women in the exercise group completed an 8-week exergame-based training program, which was focused on postural control and coordination of the upper and lower limbs, aerobic conditioning, strength, and mobility. Women (groups of 3) were encouraged to exercise for 120 minutes (over 2 sessions) per week. Main outcome measures included pain and disease effect, which were assessed with the Fibromyalgia Impact Questionnaire (FIQ), a specific measure for fibromyalgia. Secondary outcome measure included quality of life, which was assessed with the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) generic instrument. The results showed that 97.62% of participants in the exercise group completed the 8-week intervention. The exercise group showed a significant improvement (Pquality of life in women with fibromyalgia. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Risk of fatigue in cancer patients receiving anti-EGFR monoclonal antibodies: results from a systematic review and meta-analysis of randomized controlled trial.

Science.gov (United States)

Zhu, Jianhong; Zhao, Wenxia; Liang, Dan; Li, Guocheng; Qiu, Kaifeng; Wu, Junyan; Li, Jianfang

2018-04-01

To evaluate the association between fatigue and anti-epidermal growth factor receptor monoclonal antibodies (anti-EGFR MAbs), we conducted the first meta-analysis to access the incidence and risk of fatigue associated with anti-EGFR MAbs. Electronic databases were searched for randomized controlled trials (RCTs) published up to February 2017. Eligible studies were selected according to PRISMA statement. Incidence rates, risk ratio (RRs), and 95% confidence intervals (CIs) were calculated using fixed-effects or random-effects models. Outcomes of quality were summarized in accordance with the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology. Thirty-five RCTs (including 15,622 patients) were included; median follow-up ranged from 8.1 to 71.4 months, and the fatigue events were recorded and graded according to the Common Toxicity Criteria for Adverse Events version 2.0 or 3.0 in most of the included trials. For patients receiving anti-EGFR MAbs, the overall incidence of all-grade and high-grade fatigue was 54.1% and 10.5%, respectively. Compared with control, anti-EGFR MAbs significantly increased the risk of all-grade fatigue (RR 1.10, 95% CI, 1.05-1.14, moderate-quality evidence) and high-grade fatigue (RR 1.31, 95% CI, 1.19-1.45, moderate-quality evidence). No significant differences among subgroup analyses (anti-EGFR MAbs, tumor type, and median follow-up) on high-grade fatigue were observed. No evidence of publication bias was observed. The present study suggested that anti-EGFR MAbs may increase the risk of fatigue in cancer patients.

Quality control of 5mg diazepam suppositories manipulated in the city of Campos Goytacazes – RJ

OpenAIRE

Renata Aparecida Venturi Canzian; Fernanda Fraga Pessanha; Jean Carlos Brandão Storck

2012-01-01

Diazepam suppositories are widely used by children and elderly, and require close attention to quality control because it is a controlled prescription drug. The objective of the study was to analyze diazepam suppositories manipulated in Campos dos Goytacazes, RJ, to verify if they are within the required quality standards, and offer safety and efficiency to patients. We analyzed samples of 5mg diazepam suppositories acquired in five randomly selected pharmacies, identified as Pharmacy A, Phar...

The psychosocial effects of a companion robot: a randomized controlled trial.

Science.gov (United States)

Robinson, Hayley; Macdonald, Bruce; Kerse, Ngaire; Broadbent, Elizabeth

2013-09-01

To investigate the psychosocial effects of the companion robot, Paro, in a rest home/hospital setting in comparison to a control group. Randomized controlled trial. Residents were randomized to the robot intervention group or a control group that attended normal activities instead of Paro sessions. Sessions took place twice a week for an hour over 12 weeks. Over the trial period, observations were conducted of residents' social behavior when interacting as a group with the robot. As a comparison, observations were also conducted of all the residents during general activities when the resident dog was or was not present. A residential care facility in Auckland, New Zealand. Forty residents in hospital and rest home care. Residents completed a baseline measure assessing cognitive status, loneliness, depression, and quality of life. At follow-up, residents completed a questionnaire assessing loneliness, depression, and quality of life. During observations, behavior was noted and collated for instances of talking and stroking the dog/robot. In comparison with the control group, residents who interacted with the robot had significant decreases in loneliness over the period of the trial. Both the resident dog and the seal robot made an impact on the social environment in comparison to when neither was present. Residents talked to and touched the robot significantly more than the resident dog. A greater number of residents were involved in discussion about the robot in comparison with the resident dog and conversation about the robot occurred more. Paro is a positive addition to this environment and has benefits for older people in nursing home care. Paro may be able to address some of the unmet needs of older people that a resident animal may not, particularly relating to loneliness. Copyright © 2013 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

Effectiveness of flipped classrooms in Chinese baccalaureate nursing education: A meta-analysis of randomized controlled trials.

Science.gov (United States)

Hu, Rujun; Gao, Huiming; Ye, Yansheng; Ni, Zhihong; Jiang, Ning; Jiang, Xiaolian

2018-03-01

In recent years, the flipped classroom approach has been broadly applied to nursing courses in China. However, a systematic and quantitative assessment of the outcomes of this approach has not been conducted. The purpose of the meta-analysis is to evaluate the effectiveness of the flipped classroom pedagogy in Chinese baccalaureate nursing education. Meta-analysis of randomized controlled studies. All randomized controlled trials relevant to the use of flipped classrooms in Chinese nursing education were retrieved from the following databases from their date of inception through September 23, 2017: PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, CINAHL, the China National Knowledge Infrastructure, the Wanfang Database, and the Chinese Scientific Journals Database. Search terms including "flipp*", "inverted", "classroom", and "nurs*" were used to identify potential studies. We also manually searched the reference lists of the retrieved articles to identify potentially relevant studies. Two reviewers independently assessed the eligibility of each study and extracted the data. The Cochrane risk-of-bias tool was used to evaluate the quality of the studies. RevMan (Version 5.3) was used to analyze the data. Theoretical knowledge scores and skill scores (continuous data) were synthesized using the standardized mean difference (SMD) and 95% confidence interval (CI). The statistical heterogeneity of the included studies was analyzed by calculating the I 2 statistic and applying a chi-square test. Publication bias was assessed by funnel plots. The quality of the combined results was evaluated using the Grading of Recommendations Assessment, Development and Evaluation system. Eleven randomized controlled trials published between 2015 and 2017 were selected. All the included studies had a moderate possibility of bias due to low methodological quality. The meta-analysis indicated that the theoretical knowledge scores and skill scores were significantly

A quality control manual for oral radiology

International Nuclear Information System (INIS)

Peixoto, J.E.; Ferreira, R.S.; Bessa, S.O.; Domingues, C.; Gomes, C.A.; Oliveira, S.L.G.; Ortiz, J.A.P.

1988-01-01

A quality control manual for oral radiology is showed. The X-ray equipment used for this activity is described, such as the X-ray tube, collimator. The high tension in X-ray tube, the spectra, the quality and the quantity of radiation and the X-ray intensity are also analysed. (C.G.C.) [pt

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

Science.gov (United States)

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

Online psycho-education to the treatment of bipolar disorder: protocol of a randomized controlled trial.

Science.gov (United States)

González-Ortega, Itxaso; Ugarte, Amaia; Ruiz de Azúa, Sonia; Núñez, Nuria; Zubia, Marta; Ponce, Sara; Casla, Patricia; Llano, Josu Xabier; Faria, Ángel; González-Pinto, Ana

2016-12-22

Bipolar disorder patients frequently present recurrent episodes and often experience subsyndromal symptoms, cognitive impairment and difficulties in functioning, with a low quality of life, illness relapses and recurrent hospitalization. Early diagnosis and appropriate intervention may play a role in preventing neuroprogression in this disorder. New technologies represent an opportunity to develop standardized psychological treatments using internet-based tools that overcome some of the limitations of face-to-face treatments, in that they are readily accessible and the timing of therapy can be tailored to user needs and availability. However, although many psychological programs are offered through the web and mobile devices for bipolar disorder, there is a lack of high quality evidence concerning their efficacy and effectiveness due to the great variability in measures and methodology used. This clinical trial is a simple-blind randomized trial within a European project to compare an internet-based intervention with treatment as usual. Bipolar disorder patients are to be included and randomly assigned to one of two groups: 1) the experimental group (tele-care support) and 2) the control group. Participants in both groups will be evaluated at baseline (pre-treatment) and post-treatment. This study describes the design of a clinical trial based on psychoeducation intervention that may have a significant impact on both prognosis and treatment in bipolar disorder. Specifically, bringing different services together (service aggregation), it is hoped that the approach proposed will significantly increase the impact of information and communication technologies on access and adherence to treatment, quality of the service, patient safety, patient and professional satisfaction, and quality of life of patients. NCT02924415 . Retrospectively registered 27 September 2016.

The Effectiveness of Mindfulness-based Cognitive Therapy on Psychological Symptoms and Quality of Life in Systemic Lupus Erythematosus Patients: 
A Randomized Controlled Trial.

Science.gov (United States)

Solati, Kamal; Mousavi, Mohammad; Kheiri, Soleiman; Hasanpour-Dehkordi, Ali

2017-09-01

This study was conducted to determine the efficacy of mindfulness-based cognitive therapy (MBCT) on psychological symptoms and quality of life (QoL) in patients with systemic lupus erythematosus (SLE). We conducted a randomized single-blind clinical trial in patients with SLE referred from the Imam Ali Clinic in Shahrekord, southwest Iran. The patients (46 in total in two groups of 23 each) were randomly assigned into the experimental and control groups. Both groups underwent routine medical care, and the experimental group underwent eight group sessions of MBCT in addition to routine care. The patient , s QoL was assessed using the General Health Questionnaire-28 and 36-Item Short Form Health Survey before, after, and six months after intervention (follow-up). A significant difference was seen in psychological symptoms and QoL between MBCT and control groups immediately after the intervention and at follow-up ( p ≤ 0.050). However, the difference was not significant for the physical components of QoL ( p ≥ 0.050). MBCT contributed to decreased psychological symptoms and improved QoL in patients with SLE with a stable effect on psychological symptoms and psychological components of QoL, but an unstable effect on physical components.

Comparing 36.5°C with 37°C for human embryo culture: a prospective randomized controlled trial.

Science.gov (United States)

Fawzy, Mohamed; Emad, Mai; Gad, Mostafa A; Sabry, Mohamed; Kasem, Hesham; Mahmoud, Manar; Bedaiwy, Mohamed A

2018-03-27

This prospective, double-blind, randomized controlled trial was designed to evaluate the efficacy of a culture temperature of 36.5°C versus 37°C on human embryo development in vitro. A total of 412 women undergoing IVF were randomized to two groups: the oocytes and embryos of the intervention group were cultured at 36.5°C; those of the control group were cultured at 37°C. Although no significant effect of culture temperature was observed on pregnancy or implantation rates, differences were found in embryo development. Embryo culture at 36.5°C was associated with a significantly higher cleavage rate (OR 1.6, 95% CI 1.03 to 2.51), but a lower fertilization rate, fewer high-quality embryos on day 3, a lower blastocyst formation rate on day 5, and fewer high-quality and cryopreserved blastocysts (OR 0.87, 95% CI 0.78 to 0.98), (OR 0.60, 95% CI 0.53 to 0.69), (OR 0.85, 95% CI 0.75 to 0.97), (OR 0.5, 95% CI 0.44 to 0.56) and (OR 0.77, 95% CI 0.68 to 0.88), respectively, compared with 37°C. On the basis of these results, and in the absence of data on the optimal temperature for each stage of embryo development in vitro, we recommend continuation of the use of 37°C for human embryo culture. Copyright © 2018 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Study protocol: to investigate effects of highly specialized rehabilitation for patients with multiple sclerosis. A randomized controlled trial of a personalized, multidisciplinary intervention

Directory of Open Access Journals (Sweden)

Sørensen Jan

2012-09-01

Full Text Available Abstract Background Multiple sclerosis (MS is a complex, chronic and progressive disease and rehabilitation services can provide important support to patients. Few MS rehabilitation programs have been shown to provide health improvements to patients in a cost-effective manner. The objective of this study is to assess the effects in terms of changes measured by a variety of standardized quality of life, mastery, coping, compliance and individual goal-related endpoints. This combination provides the basis for analyzing the complexity of MS and outcomes of a personalized rehabilitation. Methods/Design Patients with MS referred to hospital rehabilitation services will be randomized to either early admission (within two months or usual admission (after an average waiting time of eight months. They will complete a battery of standardized health outcome instruments prior to randomization, and again six and twelve months after randomization, and a battery of goal-related outcome measures at admission and discharge, and again one, six and twelve months after randomization. Discussion The results of the study are expected to contribute to further development of MS rehabilitation services and to discussions about the design and content of such services. The results will also provide additional information to health authorities responsible for providing and financing rehabilitation services. Trial registration Current Controlled Trials (ISRCTN05245917

Design of Energy Storage Control Strategy to Improve the PV System Power Quality

DEFF Research Database (Denmark)

Lei, Mingyu; Yang, Zilong; Wang, Yibo

2016-01-01

Random fluctuation of PV power is becoming a more and more serious problem affecting the power quality and stability of grid as the PV penetration keeps increasing recent years. Aiming at this problem, this paper proposed a control strategy of energy storage system based on Model Predictive Contr...

Quality assurance and quality control

International Nuclear Information System (INIS)

Kaden, W.

1986-01-01

General preconditions and methods for QA work in the nuclear field are analysed. The application of general QA principles to actual situations is illustrated by examples in the fields of engineering and of the manufacturing of mechanical and electrical components. All QA measures must be fitted to the complexity and relevance of the work steps, which are under consideration. The key to good product quality is the control of working processes. The term 'controlled process' is discussed in detail and examples of feed back systems are given. The main QA measures for the operation of nuclear power plants include the establishment of a Quality Assurance Program, training and qualification of personnel, procurement control, inspection and tests, reviews and audits. These activities are discussed. (orig.)

Assurance and control of quality in trace element analysis

International Nuclear Information System (INIS)

Heinonen, J.

1979-01-01

The study demonstrates in practice the assurance and control of the quality of results from trace analysis in biological materials. The performance of three analytical methods is studied: one involving the determination of Cs and two the determination of As by neutron activation techniques in biological materials at the natural background level. In the case of Cs, the validity of the analytical procedure was investigated by the means available in the laboratory of the Institute and by utilizing the specific properties of the determinant. In the establishment and control of accuracy, the analysis of precision was essential. The investigation of the two different methods applied for the determination of arsenic demonstrates the many problems connected with trace analysis. For the control of accuracy a number of different kinds of reference materials (RMs) were used, namely four former intercomparison materials of the IAEA and two certified RMs of the NBS. The various tests performed revealed two different types of systematic errors. The scheme applied for the long-term surveillance of systematic and random errors is found to be suitable for the continuous control of quality of results from routine analysis. (author)

Quality control in nuclear medicine

International Nuclear Information System (INIS)

Leme, P.R.

1983-01-01

The following topics are discussed: objectives of the quality control in nuclear medicine; the necessity of the quality control in nuclear medicine; guidelines and recommendations. An appendix is given concerning the guidelines for the quality control and instrumentation in nuclear medicine. (M.A.) [pt

Randomized algorithms in automatic control and data mining

CERN Document Server

Granichin, Oleg; Toledano-Kitai, Dvora

2015-01-01

In the fields of data mining and control, the huge amount of unstructured data and the presence of uncertainty in system descriptions have always been critical issues. The book Randomized Algorithms in Automatic Control and Data Mining introduces the readers to the fundamentals of randomized algorithm applications in data mining (especially clustering) and in automatic control synthesis. The methods proposed in this book guarantee that the computational complexity of classical algorithms and the conservativeness of standard robust control techniques will be reduced. It is shown that when a problem requires "brute force" in selecting among options, algorithms based on random selection of alternatives offer good results with certain probability for a restricted time and significantly reduce the volume of operations.

Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

Directory of Open Access Journals (Sweden)

Nuria eRuffini

2015-08-01

Full Text Available Context: Heart Rate Variability (HRV indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT on ANS activity through changes of High Frequency, a heart rate variability index indicating the parasympathetic activity, in healthy subjects, compared with sham therapy and control group.Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults, both smokers and non-smokers and not on medications. At enrollment subjects were randomized in 3 groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920.Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 minutes.Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency rate (p<0.001, and decrease of sympathetic activity, as revealed by Low Frequency rate (p<0.01; results also showed a reduction of Low Frequency/High Frequency ratio (p<0.001 and Detrended fluctuation scaling exponent (p<0.05. Conclusions: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

Possibilities of obtaining and controlling high-quality pressure castings

Directory of Open Access Journals (Sweden)

S. Pietrowski

2011-07-01

Full Text Available The paper presents the influence of the type of furnace charging melting, refining and modification silumins 226 and 231 on the porosity and microstructure of castings. It was shown that in order to reduce or eliminate the porosity of the castings is necessary to the refining ECOSAL-AL113 of liquid silumin both in the melting furnace, and in the ladle and an additional nitrogen, in the heat furnace modified and refining with nitrogen. To control the effects of refining and modifying the TDA method was used. It was found that based on crystal- lization curve can be qualitatively assess the gas porosity of the castings. In order to control and quality control silumins author developed a computer program using the method of TDA, which sets out: Rm, A5, HB and casting porosity P and the concentration of hydrogen in them. The program also informs the technological procedures to be performed for liquid silumin improper preparation.

Tamsulosin, Solifenacin, and Their Combination for the Treatment of Stent-Related Symptoms: A Randomized Controlled Study.

Science.gov (United States)

Dellis, Athanasios E; Papatsoris, Athanasios G; Keeley, Francis X; Bamias, Aristotelis; Deliveliotis, Charalambos; Skolarikos, Andreas A

2017-01-01

To properly use the Ureteric Symptom Score Questionnaire (USSQ) to evaluate, in a randomized control study, the effect of tamsulosin, solifenacin, and their combination in improving symptoms and quality of life in patients with indwelling ureteral stents. After institutional review board approval, 260 patients with a ureteral stent were randomly assigned to receive tamsulosin 0.4 mg, solifenacin 5 mg, or placebo and further randomized to receive their combination. The validated USSQ was completed 1 and 4 weeks after stent insertion and 4 weeks after stent removal. Kruskal-Wallis test, chi-squared test (or Fisher's exact test), one-way analysis of variance, and T-test (or Wilcoxon rank-sum test if not normal data) were used for statistical analysis. The results were considered significant at p tamsulosin or solifenacin expressed significantly lower urinary (p tamsulosin and solifenacin alone or in combination, improves stent-related symptoms and has a positive impact on quality of life.

Use of intravenous tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials

Directory of Open Access Journals (Sweden)

FU De-jie

2013-04-01

Full Text Available 【Abstract】 Objective: The effect of tranexamic acid (TA on patients receiving total knee arthroplasty (TKA has been reported in many small clinical trials. But single trials are not sufficient enough to clarify the effectiveness and safety of TA. So, we carried out a meta-analysis of randomized controlled trials to investigate the efficacy and safety of the intravenous use of TA in TKA. Methods: Literatures were retrieved in Cochrane Library, OVID, PubMed, EMBASE, CNKI and Wanfang Data. All the related literatures were checked by two independent investigators and only the high quality randomized con-trolled trials were enrolled. Relevant data were analyzed using RevMan 5.1 to compare the difference of blood loss, transfusion and complications between TA group and con-trol group. Results: There were 353 related literatures and only 22 randomized controlled trials met the inclusion criteria. The use of TA in TKA significantly reduced total blood loss by a mean of 435.41 ml (95% CI 300.62-570.21, P<0.01, post-operative blood loss by a mean of 406.69 ml (95% CI 333.16-480.22, P<0.01. TA also significantly lowered the transfu-sion rate (risk difference 0.30, 95% CI 0.21-0.39, P<0.01 and transfusion volume (mean difference 0.95 unit, 95% CI 0.53-1.37, P<0.01. The risks between TA group and control group in developing deep vein thrombosis and pulmonary embo-lism were not statistically significant. Conclusion: TA is beneficial for patients undergoing TKA, which can significantly reduce total blood loss, post-operative blood loss, transfusion rate, and transfusion volume. Meanwhile TA is recommended to reduce deep vein thrombosis and pulmonary embolism following TKA. Key words: Tranexamic acid; Arthroplasty; Knee; Blood loss, surgical; Meta-analysis

[Pharmaceutical product quality control and good manufacturing practices].

Science.gov (United States)

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

Adapted physical activity is beneficial on balance, functional mobility, quality of life and fall risk in community-dwelling older women: a randomized single-blinded controlled trial.

Science.gov (United States)

Kovács, E; Prókai, L; Mészáros, L; Gondos, T

2013-06-01

Exercise programmes have important role in prevention of falls, but to date, we have little knowledge about the effects of Adapted Physical Activity programme on balance of older women. The aim of this study was to investigate the effects of an Adapted Physical Activity programme on balance, risk of falls and quality of life in community-dwelling older women. This was a randomized controlled study. Community, in a local sport centre. Older women aged over 60 years. Seventy-six women were randomised to an exercise group providing Adapted Physical Activity programme for 25 weeks or a control group (in which they did not participate in any exercise programme). The one-leg stance test, Timed Up and Go test, incidence of fall and the quality of life (SF-36V2) were measured at baseline and after 25 weeks. The one-leg stance test and the Timed Up and Go test in the exercise group was significantly better than in the control group after the intervention period (P=0.005; P=0.001, respectively). The Physical Functioning, Vitality and General Health subdomains of quality of life were also significantly better in the exercise group compared to the control group (P=0.004; P=0.005; P=0.038, respectively). Relative risk was 0.40 (90% CI 0.174 to 0.920) and the number needed to treat was 5 (95% CI 2.3 to 23.3). This 25-week Adapted Physical Activity programme improves static balance, functional mobility, as well as Physical Functioning, Vitality and General Health subdomains of quality of life. Based on our results, the Adapted Physical Activity programme may be a promising fall prevention exercise programme improving static balance and functional mobility for community-dwelling older women.

40 CFR 75.21 - Quality assurance and quality control requirements.

Science.gov (United States)

2010-07-01

... quality assurance audit or any other audit, the system is out-of-control. The owner or operator shall... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Quality assurance and quality control... assurance and quality control requirements. (a) Continuous emission monitoring systems. The owner or...

Internal quality control indicators of cervical cytopathology exams performed in laboratories monitored by the External Quality Control Laboratory.

Science.gov (United States)

Ázara, Cinara Zago Silveira; Manrique, Edna Joana Cláudio; Tavares, Suelene Brito do Nascimento; de Souza, Nadja Lindany Alves; Amaral, Rita Goreti

2014-09-01

To evaluate the impact of continued education provided by an external quality control laboratory on the indicators of internal quality control of cytopathology exams. The internal quality assurance indicators for cytopathology exams from 12 laboratories monitored by the External Quality Control Laboratory were evaluated. Overall, 185,194 exams were included, 98,133 of which referred to the period preceding implementation of a continued education program, while 87,061 referred to the period following this intervention. Data were obtained from the Cervical Cancer Database of the Brazilian National Health Service. Following implementation of the continued education program, the positivity index (PI) remained within recommended limits in four laboratories. In another four laboratories, the PI progressed from below the limits to within the recommended standards. In one laboratory, the PI remained low, in two laboratories, it remained very low, and in one, it increased from very low to low. The percentage of exams compatible with a high-grade squamous intraepithelial lesion (HSIL) remained within the recommended limits in five laboratories, while in three laboratories it progressed from below the recommended levels to >0.4% of the total number of satisfactory exams, and in four laboratories it remained below the standard limit. Both the percentage of atypical squamous cells of undetermined significance (ASC-US) in relation to abnormal exams, and the ratio between ASC-US and intraepithelial lesions remained within recommended levels in all the laboratories investigated. An improvement was found in the indicators represented by the positivity index and the percentage of exams compatible with a high-grade squamous intraepithelial lesion, showing that the role played by the external quality control laboratory in providing continued education contributed towards improving laboratory staff skills in detecting cervical cancer precursor lesions.

Quality control of radiopharmaceuticals

International Nuclear Information System (INIS)

Kristensen, K.

1981-01-01

Quality assurance was introduced in the pharmaceutical field long before it was used in many other areas, and the term quality control has been used in a much broader sense than merely analytical quality control. The term Good Manufacturing Practice (GMP) has been used to describe the system used for producing safe and effective drugs of a uniform quality. GMP has also been used for the industrial production of radiopharmaceuticals. For the preparation and control of radiopharmaceuticals in hospitals a similar system has been named Good Radiopharmacy Practice (GRP). It contains the same elements as GMP but takes into account the special nature of this group of drugs. Data on the assessment of the quality of radiopharmaceuticals in relation to present standards are reviewed. The general conclusion is that the quality of radiopharmaceuticals appears comparable to that of other drugs. It seems possible to establish the production of radiopharmaceuticals, generators and preparation kits in such a way that analytical control of the final product at the hospital may be limited provided the final preparation work is carried out in accordance with GRP principles. The elements of GRP are reviewed. (author)

The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial.

Science.gov (United States)

Ahmed, Sara; Ernst, Pierre; Bartlett, Susan J; Valois, Marie-France; Zaihra, Tasneem; Paré, Guy; Grad, Roland; Eilayyan, Owis; Perreault, Robert; Tamblyn, Robyn

2016-12-01

Whether Web-based technologies can improve disease self-management is uncertain. My Asthma Portal (MAP) is a Web-based self-management support system that couples evidence-based behavioral change components (self-monitoring of symptoms, physical activity, and medication adherence) with real-time monitoring, feedback, and support from a nurse case manager. The aim of this study was to compare the impact of access to a Web-based asthma self-management patient portal linked to a case-management system (MAP) over 6 months compared with usual care on asthma control and quality of life. A multicenter, parallel, 2-arm, pilot, randomized controlled trial was conducted with 100 adults with confirmed diagnosis of asthma from 2 specialty clinics. Asthma control was measured using an algorithm based on overuse of fast-acting bronchodilators and emergency department visits, and asthma-related quality of life was assessed using the Mini-Asthma Quality of Life Questionnaire (MAQLQ). Secondary mediating outcomes included asthma symptoms, depressive symptoms, self-efficacy, and beliefs about medication. Process evaluations were also included. A total of 49 individuals were randomized to MAP and 51 to usual care. Compared with usual care, participants in the intervention group reported significantly higher asthma quality of life (mean change 0.61, 95% CI 0.03 to 1.19), and the change in asthma quality of life for the intervention group between baseline and 3 months (mean change 0.66, 95% CI 0.35 to 0.98) was not seen in the control group. No significant differences in asthma quality of life were found between the intervention and control groups at 6 (mean change 0.46, 95% CI -0.12 to 1.05) and 9 months (mean change 0.39, 95% CI -0.2 to 0.98). For poor control status, there was no significant effect of group, time, or group by time. For all self-reported measures, the intervention group had a significantly higher proportion of individuals, demonstrating a minimal clinically

Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

Science.gov (United States)

Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

2015-11-01

Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

Commercial jet fuel quality control

Energy Technology Data Exchange (ETDEWEB)

Strauss, K.H.

1995-05-01

The paper discusses the purpose of jet fuel quality control between the refinery and the aircraft. It describes fixed equipment, including various types of filters, and the usefulness and limitations of this equipment. Test equipment is reviewed as are various surveillance procedures. These include the Air Transport Association specification ATA 103, the FAA Advisory Circular 150/5230-4, the International Air Transport Association Guidance Material for Fuel Quality Control and Fuelling Service and the Guidelines for Quality Control at Jointly Operated Fuel Systems. Some past and current quality control problems are briefly mentioned.

SPECT quality control tests

International Nuclear Information System (INIS)

Robilotta, C.C.; Rebelo, M.F.S.; Oliveira, M.A.; Abe, R.

1987-01-01

Quality control tests of tomographic system composed by a rotatory chamber (CGR Gammatomome T-9000) and a microcomputer are presented. Traditional quality control tests for scintilation chambers and specific tests for tomographic systems are reported. (M.A.C.) [pt

The use of Animal-Assisted Therapy in adolescents with acute mental disorders: A randomized controlled study.

Science.gov (United States)

Stefanini, M C; Martino, A; Allori, P; Galeotti, F; Tani, F

2015-02-01

The aim of this study was to compare the effects of Animal-Assisted Therapy (AAT) with a standard treatment protocol in children and adolescents admitted to the psychiatry hospital for acute mental disorders. We used a methodology involving high quality standards for AAT research. A pre-post experimental design with a randomized controlled trial (RCT) in 34 hospitalized patients (17 treatment, 17 control) was carried out. The study focused on improvement in clinical status including, global functioning measured by the Children Global Assessment Scale (C GAS), format of care and ordinary school attendance measured by a rating scale. Our results indicate a statistically significant improvement in global functioning, reduction in format of care and increased ordinary school attendance in the treatment group, but not in the control group. Our results verify that AAT can have significant positive effects on therapeutic progress and the recovery process. Copyright © 2015 Elsevier Ltd. All rights reserved.

Home-based video exercise intervention for community-dwelling frail older women: a randomized controlled trial

DEFF Research Database (Denmark)

Vestergaard, Sonja; Kronborg, Christian; Puggaard, Lis

2008-01-01

and health-related quality of life. METHODS: Communitydwelling frail women >/=75 yrs, receiving public home care, were randomized into a training group (n=30) and a control group (n=31). Participants exercised for 26 minutes, three times per week for five months. Both groups received a bi-weekly telephone...... call. The effect of intervention was evaluated by the physical performance test, mobility-tiredness score, maximal isometric handgrip and biceps strength, lower limb explosive power, repeated chair rise (5 times), 10-m maximal walking-speed, semi-tandem balance, and health-related quality of life......, handgrip, biceps strength, chair rise, and 10-m maximal walking-speed in the training group, and for walking-speed and self-rated health in the control group. CONCLUSIONS: These results suggest that homebased training for frail older women using an exercise video induces lasting health-related quality...

Survey of product quality control of radioactive waste

International Nuclear Information System (INIS)

Warnecke, E.

1989-01-01

The PTB has developed basic procedures with regard to deriving final storage conditions and product quality control. After this, requirements for radioactive waste are derived via safety analysers, in which information about the radioactive waste, the geological overall situation of the site and the layout of the final storage mine, in particular, are included as basic data. The final storage conditions are only determined with the awarding of the planning decision. Compliance with them can be proved by random sample tests on waste containers or via a qualification and inspection of the conditioning process. (DG) [de

Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

Directory of Open Access Journals (Sweden)

van Balkom Anton

2008-11-01

Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an

The process of managerial control in quality improvement initiatives.

Science.gov (United States)

Slovensky, D J; Fottler, M D

1994-11-01

The fundamental intent of strategic management is to position an organization with in its market to exploit organizational competencies and strengths to gain competitive advantage. Competitive advantage may be achieved through such strategies as low cost, high quality, or unique services or products. For health care organizations accredited by the Joint Commission on Accreditation of Healthcare Organizations, continually improving both processes and outcomes of organizational performance--quality improvement--in all operational areas of the organization is a mandated strategy. Defining and measuring quality and controlling the quality improvement strategy remain problematic. The article discusses the nature and processes of managerial control, some potential measures of quality, and related information needs.

A Meta-Analysis of Randomized Controlled Trials of Yiqi Yangyin Huoxue Method in Treating Diabetic Nephropathy

Directory of Open Access Journals (Sweden)

Jiao Ying Ou

2016-01-01

Full Text Available Objective. The purpose of this systematic review is to evaluate the evidence of Yiqi Yangyin Huoxue Method for diabetic nephropathy. Methods. 11 electronic databases, through September 2015, were searched to identify randomized controlled trials of Yiqi Yangyin Huoxue Method for diabetic nephropathy. The quality of the included trials was assessed using the Jadad scale. Results. 26 randomized controlled trials were included in our review. Of all the included trials, most of them were considered as high quality. The aggregated results suggested that Yiqi Yangyin Huoxue Method is beneficial to diabetic nephropathy in bringing down the microalbuminuria (SMD = −0.98, 95% CI −1.22 to −0.74, serum creatinine (SMD = −0.56, 95% CI −0.93 to −0.20, beta-2 microglobulin (MD = 0.06, 95% CI 0.01 to 0.12, fasting plasma glucose (MD = −0.35, 95% CI −0.62 to −0.08, and 2-hour postprandial blood glucose (MD = 1.13, 95% CI 0.07 to 2.20, but not in decreasing blood urea nitrogen (SMD = −0.72, 95% CI −1.47 to 0.02 or 2-hour postprandial blood glucose (SMD = −0.48, 95% CI −1.01 to 0.04. Conclusions. Yiqi Yangyin Huoxue Method should be a valid complementary and alternative therapy in the management of diabetic nephropathy, especially in improving UAER, serum creatinine, fasting blood glucose, and beta-2 microglobulin. However, more studies with long follow-up are warrant to confirm the current findings.

Randomized controlled trial of video self-modeling following speech restructuring treatment for stuttering.

Science.gov (United States)

Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

2010-08-01

In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech restructuring treatment. Post treatment, participants were randomly assigned to 2 trial arms: standard maintenance and standard maintenance plus VSM. Participants in the latter arm viewed stutter-free videos of themselves each day for 1 month. The addition of VSM did not improve speech outcomes, as measured by percent syllables stuttered, at either 1 or 6 months postrandomization. However, at the latter assessment, self-rating of worst stuttering severity by the VSM group was 10% better than that of the control group, and satisfaction with speech fluency was 20% better. Quality of life was also better for the VSM group, which was mildly to moderately impaired compared with moderate impairment in the control group. VSM intervention after treatment was associated with improvements in self-reported outcomes. The clinical implications of this finding are discussed.

Creative art therapy to enhance rehabilitation for stroke patients: a randomized controlled trial.

Science.gov (United States)

Kongkasuwan, Ratcharin; Voraakhom, Kotchakorn; Pisolayabutra, Prim; Maneechai, Pichai; Boonin, Jiraporn; Kuptniratsaikul, Vilai

2016-10-01

To examine the efficacy of creative art therapy plus conventional physical therapy, compared with physical therapy only, in increasing cognitive ability, physical functions, psychological status and quality of life of stroke patients. Randomized controlled trial with blinded assessor. An in-patient setting PARTICIPANTS: One hundred and eighteen stroke patients aged ⩾50 years who could communicate verbally. All participants received conventional physical therapy five days per week. An intervention group received additional creative art therapy, twice a week for four weeks, in a rehabilitation ward. Cognitive function, anxiety and depression, physical performance and quality of life were measured with the Abbreviated Mental Test, the Hospital Anxiety and Depression Scale, the modified Barthel Index scale and the pictorial Thai Quality of Life questionnaire, respectively. Mean differences for the intervention group were significantly greater than the control group for depression (-4.5, 95% CI -6.5, -2.5, part therapy and most reported improved concentration (68.5%), emotion (79.6%), self-confidence (72.2%) and motivation (74.1%). Creative art therapy combined with conventional physical therapy can significantly decrease depression, improve physical functions and increase quality of life compared with physical therapy alone. © The Author(s) 2015.

Functional High-Intensity Circuit Training Improves Body Composition, Peak Oxygen Uptake, Strength, and Alters Certain Dimensions of Quality of Life in Overweight Women

OpenAIRE

Sperlich, Billy; Wallmann-Sperlich, Birgit; Zinner, Christoph; Von Stauffenberg, Valerie; Losert, Helena; Holmberg, Hans-Christer

2017-01-01

Source at https://doi.org/10.3389/fphys.2017.00172 The effects of circuit-like functional high-intensity training (CircuitHIIT) alone or in combination with high-volume low-intensity exercise (Circuitcombined) on selected cardio-respiratory and metabolic parameters, body composition, functional strength and the quality of life of overweight women were compared. In this single-center, two-armed randomized, controlled study, overweight women performed 9-weeks (3 sessions·wk−1) of either Ci...

Optimal control of a high-frequency class-D amplifier

DEFF Research Database (Denmark)

Dahl, Nicolai J.; Iversen, Niels Elkjær; Knott, Arnold

2018-01-01

Control loops have been used with switch-mode audio amplifiers to improve the sound quality of the amplifier. Because these amplifiers use a high-frequency modulation, precautions in the controller design must be taken. Further, the quality factor of the output filter can have a great impact...... on the controller's capabilities to suppress noise and track the audio signal. In this paper design methods for modern control are presented. The control method proves to easily overcome the challenge of designing a good performing controller when the output filter has a high quality factor. The results show...... that the controller is able to produce a clear improvement in the Total Harmonic Distortion with up to a 30 times improvement compared to open-loop with a clear reduction in the noise. This places the audio quality on pair with current solutions....

A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

Science.gov (United States)

Zangrillo, Alberto; Alvaro, Gabriele; Pisano, Antonio; Guarracino, Fabio; Lobreglio, Rosetta; Bradic, Nikola; Lembo, Rosalba; Gianni, Stefano; Calabrò, Maria Grazia; Likhvantsev, Valery; Grigoryev, Evgeny; Buscaglia, Giuseppe; Pala, Giovanni; Auci, Elisabetta; Amantea, Bruno; Monaco, Fabrizio; De Vuono, Giovanni; Corcione, Antonio; Galdieri, Nicola; Cariello, Claudia; Bove, Tiziana; Fominskiy, Evgeny; Auriemma, Stefano; Baiocchi, Massimo; Bianchi, Alessandro; Frontini, Mario; Paternoster, Gianluca; Sangalli, Fabio; Wang, Chew-Yin; Zucchetti, Maria Chiara; Biondi-Zoccai, Giuseppe; Gemma, Marco; Lipinski, Michael J; Lomivorotov, Vladimir V; Landoni, Giovanni

2016-07-01

Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. Double-blind, placebo-controlled, multicenter randomized trial. Tertiary care hospitals. Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours. The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery. Copyright © 2016 Elsevier Inc. All rights reserved.

Effects of a Randomized Couple-Based Intervention on Quality of Life of Breast Cancer Patients and Their Partners

Science.gov (United States)

Kayser, Karen; Feldman, Barry N.; Borstelmann, Nancy A.; Daniels, Ann A.

2010-01-01

The purpose of this study was to determine the effectiveness of a couple-based intervention on the quality of life (QOL) of early-stage breast cancer patients and their partners. A randomized controlled design was used to assign couples to either the hospital standard social work services (SSWS) or a couple-based intervention, the Partners in…

Moxibustion treatment for primary osteoporosis: A systematic review of randomized controlled trials.

Directory of Open Access Journals (Sweden)

Fanping Xu

Full Text Available Primary osteoporosis (POP has a serious impact on quality of life for middle-aged and elderly, which particularly increase the risk of fracture. We conducted the systematic review to evaluate the effects of moxibustion for POP in randomized controlled trials (RCTs.Eight databases were searched from their inception to July 30, 2016. The RCTs reporting the moxibustion as a monotherapy or in combination with conventional therapy for POP were enrolled. The outcomes might be fracture incidence, quality of life, clinical symptoms, death attributed to osteoporosis, adverse effect, bone mineral density (BMD, and biochemical indicators. Literature selection, data abstraction, quality evaluation, and data analysis were in accordance with Cochrane standards.Thirteen trials including 808 patients were included. Meta-analysis was not conducted because of the obvious clinical or statistical heterogeneity. Limited evidence suggested that moxibustion plus anti-osteoporosis medicine might be more effective in relieving the pain (visual analogue scale scores average changed 2 scores between groups, 4 trials, increasing the BMD of femoral neck (average changed 0.4 g/cm2 between groups, 3 trials, and improving the level of bone gla protein, osteoprotegerin and bone alkaline phosphatase (2 trials compared with anti-osteoporosis medicine alone. However, the quality of previous studies was evaluated as generally poor. The safety evidence of moxibustion was still insufficient. Due to the paucity of high-quality studies, there was no definite conclusion about the efficacy and safety of moxibustion treating POP although parts of positive results were presented. Future research should pay attention to the dose-response relation and fracture incidence of moxibustion for POP.

Research on the Random Shock Vibration Test Based on the Filter-X LMS Adaptive Inverse Control Algorithm

Directory of Open Access Journals (Sweden)

Wang Wei

2016-01-01

Full Text Available The related theory and algorithm of adaptive inverse control were presented through the research which pointed out the adaptive inverse control strategy could effectively eliminate the noise influence on the system control. Proposed using a frequency domain filter-X LMS adaptive inverse control algorithm, and the control algorithm was applied to the two-exciter hydraulic vibration test system of random shock vibration control process and summarized the process of the adaptive inverse control strategies in the realization of the random shock vibration test. The self-closed-loop and field test show that using the frequency-domain filter-X LMS adaptive inverse control algorithm can realize high precision control of random shock vibration test.

The effect of ginseng (the genus panax on glycemic control: a systematic review and meta-analysis of randomized controlled clinical trials.

Directory of Open Access Journals (Sweden)

Esra' Shishtar

Full Text Available Despite the widespread use of ginseng in the management of diabetes, supporting evidence of its anti-hyperglycemic efficacy is limited, necessitating the need for evidence-based recommendations for the potential inclusion of ginseng in diabetes management.To elucidate the effect of ginseng on glycemic control in a systematic review and meta-analysis of randomized controlled trials in people with and without diabetes.MEDLINE, EMBASE, CINAHL and the Cochrane Library (through July 3, 2013.Randomized controlled trials ≥30 days assessing the glycemic effects of ginseng in people with and without diabetes.Relevant data were extracted by 2 independent reviewers. Discrepancies were resolved by consensus. The Heyland Methodological Quality Score and the Cochrane risk of bias tool were used to assess study quality and risk of bias respectively.Sixteen trials were included, in which 16 fasting blood glucose (n = 770, 10 fasting plasma insulin (n = 349, 9 glycated hemoglobin (n = 264, and 7 homeostasis model assessment of insulin resistance (n = 305 comparisons were reported. Ginseng significantly reduced fasting blood glucose compared to control (MD =  -0.31 mmol/L [95% CI: -0.59 to -0.03], P = 0.03. Although there was no significant effect on fasting plasma insulin, glycated hemoglobin, or homeostasis model assessment of insulin resistance, a priori subgroup analyses did show significant reductions in glycated hemoglobin in parallel compared to crossover trials (MD = 0.22% [95%CI: 0.06 to 0.37], P = 0.01.Most trials were of short duration (67% trials<12wks, and included participants with a relatively good glycemic control (median HbA1c non-diabetes = 5.4% [2 trials]; median HbA1c diabetes = 7.1% [7 trials].Ginseng modestly yet significantly improved fasting blood glucose in people with and without diabetes. In order to address the uncertainty in our effect estimates and provide better assessments of ginseng's anti

EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol

Directory of Open Access Journals (Sweden)

Chamorro-Viña Carolina

2012-09-01

Full Text Available Abstract Background Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The primary objective of this randomized-controlled trial (RCT is to study the effect of an exercise program (in- and outpatient on immune cell recovery in patients undergoing an autologous stem cell transplantation. The secondary objective is to determine if an exercise intervention diminishes the usual deterioration in quality of life, physical fitness, and the acquisition of a sedentary lifestyle. Methods This RCT has received approval from The Conjoint Health Research Ethics Board (CHREB of the University of Calgary (Ethics ID # E-24476. Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years in the Alberta Children’s Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in- and outpatient from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system

Quality assurance and quality control of nuclear engineering during construction phase

International Nuclear Information System (INIS)

Zhang Zhihua; Deng Yue; Liu Yaoguang; Xu Xianqi; Zhou Shan; Qian Dazhi; Zhang Yang

2007-01-01

The quality assurance (QA) and quality control (QC) is a very important work in the nuclear engineering. This paper starts with how to establish quality assurance system of nuclear engineering construction phase, then introduces several experiments and techniques such as the implementation of quality assurance program, the quality assurance and quality control of contractors, the quality surveillance and control of supervisory companies, quality assurance audit and surveillance of builders. (authors)

Internal quality control: planning and implementation strategies.

Science.gov (United States)

Westgard, James O

2003-11-01

The first essential in setting up internal quality control (IQC) of a test procedure in the clinical laboratory is to select the proper IQC procedure to implement, i.e. choosing the statistical criteria or control rules, and the number of control measurements, according to the quality required for the test and the observed performance of the method. Then the right IQC procedure must be properly implemented. This review focuses on strategies for planning and implementing IQC procedures in order to improve the quality of the IQC. A quantitative planning process is described that can be implemented with graphical tools such as power function or critical-error graphs and charts of operating specifications. Finally, a total QC strategy is formulated to minimize cost and maximize quality. A general strategy for IQC implementation is recommended that employs a three-stage design in which the first stage provides high error detection, the second stage low false rejection and the third stage prescribes the length of the analytical run, making use of an algorithm involving the average of normal patients' data.

High-resolution wavefront control of high-power laser systems

International Nuclear Information System (INIS)

Brase, J.; Brown, C.; Carrano, C.; Kartz, M.; Olivier, S.; Pennington, D.; Silva, D.

1999-01-01

Nearly every new large-scale laser system application at LLNL has requirements for beam control which exceed the current level of available technology. For applications such as inertial confinement fusion, laser isotope separation, laser machining, and laser the ability to transport significant power to a target while maintaining good beam quality is critical. There are many ways that laser wavefront quality can be degraded. Thermal effects due to the interaction of high-power laser or pump light with the internal optical components or with the ambient gas are common causes of wavefront degradation. For many years, adaptive optics based on thing deformable glass mirrors with piezoelectric or electrostrictive actuators have be used to remove the low-order wavefront errors from high-power laser systems. These adaptive optics systems have successfully improved laser beam quality, but have also generally revealed additional high-spatial-frequency errors, both because the low-order errors have been reduced and because deformable mirrors have often introduced some high-spatial-frequency components due to manufacturing errors. Many current and emerging laser applications fall into the high-resolution category where there is an increased need for the correction of high spatial frequency aberrations which requires correctors with thousands of degrees of freedom. The largest Deformable Mirrors currently available have less than one thousand degrees of freedom at a cost of approximately $1M. A deformable mirror capable of meeting these high spatial resolution requirements would be cost prohibitive. Therefore a new approach using a different wavefront control technology is needed. One new wavefront control approach is the use of liquid-crystal (LC) spatial light modulator (SLM) technology for the controlling the phase of linearly polarized light. Current LC SLM technology provides high-spatial-resolution wavefront control, with hundreds of thousands of degrees of freedom, more

Adding high-intensity interval training to conventional training modalities: optimizing health-related outcomes during chemotherapy for breast cancer: the OptiTrain randomized controlled trial.

Science.gov (United States)

Mijwel, Sara; Backman, Malin; Bolam, Kate A; Jervaeus, Anna; Sundberg, Carl Johan; Margolin, Sara; Browall, Maria; Rundqvist, Helene; Wengström, Yvonne

2018-02-01

Exercise training is an effective and safe way to counteract cancer-related fatigue (CRF) and to improve health-related quality of life (HRQoL). High-intensity interval training has proven beneficial for the health of clinical populations. The aim of this randomized controlled trial was to compare the effects of resistance and high-intensity interval training (RT-HIIT), and moderate-intensity aerobic and high-intensity interval training (AT-HIIT) to usual care (UC) in women with breast cancer undergoing chemotherapy. The primary endpoint was CRF and the secondary endpoints were HRQoL and cancer treatment-related symptoms. Two hundred and forty women planned to undergo chemotherapy were randomized to supervised RT-HIIT, AT-HIIT, or UC. Measurements were performed at baseline and at 16 weeks. Questionnaires included Piper Fatigue Scale, EORTC-QLQ-C30, and Memorial Symptom Assessment Scale. The RT-HIIT group was superior to UC for CRF: total CRF (p = 0.02), behavior/daily life (p = 0.01), and sensory/physical (p = 0.03) CRF. Role functioning significantly improved while cognitive functioning was unchanged for RT-HIIT compared to declines shown in the UC group (p = 0.04). AT-HIIT significantly improved emotional functioning versus UC (p = 0.01) and was superior to UC for pain symptoms (p = 0.03). RT-HIIT reported a reduced symptom burden, while AT-HIIT remained stable compared to deteriorations shown by UC (p HIIT was superior to UC for total symptoms (p HIIT was effective in preventing increases in CRF and in reducing symptom burden for patients during chemotherapy for breast cancer. These findings add to a growing body of evidence supporting the inclusion of structured exercise prescriptions, including HIIT, as a vital component of cancer rehabilitation. Clinicaltrials.gov Registration Number: NCT02522260.